Thoracic Surgery News (Archived)

Dr. Michael Ellis DeBakey, pioneer heart surgeon and medical device innovator, died July 11, 2008, in Houston, about 2 months shy of his 100th birthday on Sept. 7.

In his lifetime, Dr. DeBakey was renowned for his immense contributions to the progress of medical science, such that he was declared a "living legend" by the Library of Congress and was this year awarded a Congressional Gold Medal for his lifetime achievements, in particular his pioneering work as a heart surgeon.

And although it was as a heart surgeon that Dr. DeBakey gained greatest fame, his accomplisments in vascular surgery were unique and profound, from his development of the Dacron graft to his active membership in the SVS, and his role as founder and first editor of the Journal of Vascular Surgery.

Even before Dr. DeBakey received his medical degree from Tulane University in 1932, he began his contributions to modern medicine by developing a small continuous flow–roller pump designed to improve blood transfusion—a device that would later be used by Dr. John Gibbon as a crucial component of his heart-lung machine. And in 1939, with his mentor, Dr. Alton Ochsner, Dr. DeBakey suggested a strong link between smoking and lung cancer.

After internships in New Orleans and surgical training in Europe, Dr. DeBakey volunteered for service during World War II and was assigned to the U.S. Army Surgeon General’s office. From his observations in the field, he became convinced of the need for a mobile surgical unit that would give soldiers access to high-level medical treatment on the combat field and convinced the surgeon general to form what would become the mobile army surgical hospitals (MASH units)—an innovation that gained him the U.S. Army Legion of Merit in 1945.

His government service continued throughout his civilian career, as he helped to establish the Veterans Administration medical center research system. He also initiated the movement that in 1956 took the Army’s poorly housed medical library and used it to create the National Library of Medicine, of which he was first board member and then chairman. He served three terms on the National Heart, Lung, and Blood Advisory Council as well. He was responsible for helping establish health care systems in a host of countries, including Belgium, China, Egypt, England, Germany, Saudi Arabia, Australia, and numerous other Middle Eastern and Central and South American nations.

According to the Web site of Baylor College of Medicine’s department of surgery, where he spent almost his entire postwar career, Dr. DeBakey operated on more than 60,000 patients in the Houston area alone. But these were not all just standard operations. In 1953, he performed the first successful carotid endarterectomy, as well as the first successful removal and graft replacement of a fusiform thoracic aortic aneurysm, and in 1954, the first successful resection and graft replacement of an aneurysm of the distal aortic arch and upper descending thoracic aorta.

In 1955 he performed the first successful resection of a thoracoabdominal aortic aneurysm using the DeBakey Dacron graft—the first artificial arterial graft of its kind.

"If we now tried to develop the Dacron graft the way we developed it, I am not sure we would have it today with the way they regulate things. ...When I went down to the department store . . . they said, ‘We are fresh out of nylon, but we do have a new material called Dacron.’ I felt it, and it looked good to me. So I bought a yard of it. . . . I took this yard of Dacron cloth, I cut two sheets the width I wanted, sewed the edges on each side, and made a tube out of it. . . . We put the graft on a stent, wrapped nylon thread around it, pushed it together, and baked it. . . . After about two or three years of laboratory work on my own [including experiments in dogs], I decided that it was time to put the graft in a human being. I did not have a committee to approve it. . . . In 1954, I put the first one in during an abdominal aortic aneurysm. That first patient lived, I think, for 13 years and never had any trouble," Dr. DeBakey related in an interview published in 1996 in the Journal of Vascular Surgery.

And among his other pioneering surgical developments, in 1964, Dr. DeBakey was the first to perform a successful coronary artery bypass, using a portion of leg vein as the graft, in what is now one of the most commonly performed heart operations—coronary artery bypass grafting.

As if surgically repairing failing hearts was not enough, Dr. DeBakey became a pioneer of artificial heart research and of cardiac assist devices. On July 18, 1963, after years of animal research, he performed the first successful human implantation of a left ventricular assist device (LVAD), one which he devised; the patient died after 4 days from causes unrelated to the technology. In 1966, Dr. DeBakey’s redesigned, extracorporeal pneumatic pump was used in a 37-year-old woman who could not be weaned from the heart-lung machine after dual valve replacement. After 10 days of LVAD support, she recovered sufficiently for the pump to be removed and she survived. This pump served as the basis of Dr. DeBakey’s first total artificial heart model, created in 1968.

Dr. DeBakey was honored profusely throughout his lifetime by the medical community and the general public. Numerous medical facilities are named after him in this country and around the world. He received countless awards for his technical and social achievements in medicine. Among these honors were the American Medical Association’s Distinguished Service Award (1959), the Albert Lasker Award for Clinical Medical Research (1963), the Presidential Medal of Freedom (1969), and the National Medal of Science (1987). More recently, he was the first foreign member elected to the Russian Academy of Sciences (1999), was given the Library of Congress Bicentennial Living Legend Award (2000), and was awarded the Congressional Gold Medal in April 2008.

In his death, Dr. DeBakey was the first Houston resident given the honor of lying in state at City Hall and, at the request of his family, he lay dressed in his characteristic glasses, scrubs, and white coat for viewing by long lines of the general public.n

Sources and suggested readingsHeart Fail. Clin. 2007;3:117-20.J. Vasc. Surg. 1996;23:1031-4.

Dr. Michael Ellis DeBakey, pioneer heart surgeon and medical device innovator, died July 11, 2008, in Houston, about 2 months shy of his 100th birthday on Sept. 7.

In his lifetime, Dr. DeBakey was renowned for his immense contributions to the progress of medical science, such that he was declared a "living legend" by the Library of Congress and was this year awarded a Congressional Gold Medal for his lifetime achievements, in particular his pioneering work as a heart surgeon.

And although it was as a heart surgeon that Dr. DeBakey gained greatest fame, his accomplisments in vascular surgery were unique and profound, from his development of the Dacron graft to his active membership in the SVS, and his role as founder and first editor of the Journal of Vascular Surgery.

Even before Dr. DeBakey received his medical degree from Tulane University in 1932, he began his contributions to modern medicine by developing a small continuous flow–roller pump designed to improve blood transfusion—a device that would later be used by Dr. John Gibbon as a crucial component of his heart-lung machine. And in 1939, with his mentor, Dr. Alton Ochsner, Dr. DeBakey suggested a strong link between smoking and lung cancer.

After internships in New Orleans and surgical training in Europe, Dr. DeBakey volunteered for service during World War II and was assigned to the U.S. Army Surgeon General’s office. From his observations in the field, he became convinced of the need for a mobile surgical unit that would give soldiers access to high-level medical treatment on the combat field and convinced the surgeon general to form what would become the mobile army surgical hospitals (MASH units)—an innovation that gained him the U.S. Army Legion of Merit in 1945.

His government service continued throughout his civilian career, as he helped to establish the Veterans Administration medical center research system. He also initiated the movement that in 1956 took the Army’s poorly housed medical library and used it to create the National Library of Medicine, of which he was first board member and then chairman. He served three terms on the National Heart, Lung, and Blood Advisory Council as well. He was responsible for helping establish health care systems in a host of countries, including Belgium, China, Egypt, England, Germany, Saudi Arabia, Australia, and numerous other Middle Eastern and Central and South American nations.

According to the Web site of Baylor College of Medicine’s department of surgery, where he spent almost his entire postwar career, Dr. DeBakey operated on more than 60,000 patients in the Houston area alone. But these were not all just standard operations. In 1953, he performed the first successful carotid endarterectomy, as well as the first successful removal and graft replacement of a fusiform thoracic aortic aneurysm, and in 1954, the first successful resection and graft replacement of an aneurysm of the distal aortic arch and upper descending thoracic aorta.

In 1955 he performed the first successful resection of a thoracoabdominal aortic aneurysm using the DeBakey Dacron graft—the first artificial arterial graft of its kind.

"If we now tried to develop the Dacron graft the way we developed it, I am not sure we would have it today with the way they regulate things. ...When I went down to the department store . . . they said, ‘We are fresh out of nylon, but we do have a new material called Dacron.’ I felt it, and it looked good to me. So I bought a yard of it. . . . I took this yard of Dacron cloth, I cut two sheets the width I wanted, sewed the edges on each side, and made a tube out of it. . . . We put the graft on a stent, wrapped nylon thread around it, pushed it together, and baked it. . . . After about two or three years of laboratory work on my own [including experiments in dogs], I decided that it was time to put the graft in a human being. I did not have a committee to approve it. . . . In 1954, I put the first one in during an abdominal aortic aneurysm. That first patient lived, I think, for 13 years and never had any trouble," Dr. DeBakey related in an interview published in 1996 in the Journal of Vascular Surgery.

And among his other pioneering surgical developments, in 1964, Dr. DeBakey was the first to perform a successful coronary artery bypass, using a portion of leg vein as the graft, in what is now one of the most commonly performed heart operations—coronary artery bypass grafting.

As if surgically repairing failing hearts was not enough, Dr. DeBakey became a pioneer of artificial heart research and of cardiac assist devices. On July 18, 1963, after years of animal research, he performed the first successful human implantation of a left ventricular assist device (LVAD), one which he devised; the patient died after 4 days from causes unrelated to the technology. In 1966, Dr. DeBakey’s redesigned, extracorporeal pneumatic pump was used in a 37-year-old woman who could not be weaned from the heart-lung machine after dual valve replacement. After 10 days of LVAD support, she recovered sufficiently for the pump to be removed and she survived. This pump served as the basis of Dr. DeBakey’s first total artificial heart model, created in 1968.

Dr. DeBakey was honored profusely throughout his lifetime by the medical community and the general public. Numerous medical facilities are named after him in this country and around the world. He received countless awards for his technical and social achievements in medicine. Among these honors were the American Medical Association’s Distinguished Service Award (1959), the Albert Lasker Award for Clinical Medical Research (1963), the Presidential Medal of Freedom (1969), and the National Medal of Science (1987). More recently, he was the first foreign member elected to the Russian Academy of Sciences (1999), was given the Library of Congress Bicentennial Living Legend Award (2000), and was awarded the Congressional Gold Medal in April 2008.

In his death, Dr. DeBakey was the first Houston resident given the honor of lying in state at City Hall and, at the request of his family, he lay dressed in his characteristic glasses, scrubs, and white coat for viewing by long lines of the general public.n

Sources and suggested readingsHeart Fail. Clin. 2007;3:117-20.J. Vasc. Surg. 1996;23:1031-4.

Dr. Michael Ellis DeBakey, pioneer heart surgeon and medical device innovator, died July 11, 2008, in Houston, about 2 months shy of his 100th birthday on Sept. 7.

In his lifetime, Dr. DeBakey was renowned for his immense contributions to the progress of medical science, such that he was declared a "living legend" by the Library of Congress and was this year awarded a Congressional Gold Medal for his lifetime achievements, in particular his pioneering work as a heart surgeon.

And although it was as a heart surgeon that Dr. DeBakey gained greatest fame, his accomplisments in vascular surgery were unique and profound, from his development of the Dacron graft to his active membership in the SVS, and his role as founder and first editor of the Journal of Vascular Surgery.

Even before Dr. DeBakey received his medical degree from Tulane University in 1932, he began his contributions to modern medicine by developing a small continuous flow–roller pump designed to improve blood transfusion—a device that would later be used by Dr. John Gibbon as a crucial component of his heart-lung machine. And in 1939, with his mentor, Dr. Alton Ochsner, Dr. DeBakey suggested a strong link between smoking and lung cancer.

After internships in New Orleans and surgical training in Europe, Dr. DeBakey volunteered for service during World War II and was assigned to the U.S. Army Surgeon General’s office. From his observations in the field, he became convinced of the need for a mobile surgical unit that would give soldiers access to high-level medical treatment on the combat field and convinced the surgeon general to form what would become the mobile army surgical hospitals (MASH units)—an innovation that gained him the U.S. Army Legion of Merit in 1945.

His government service continued throughout his civilian career, as he helped to establish the Veterans Administration medical center research system. He also initiated the movement that in 1956 took the Army’s poorly housed medical library and used it to create the National Library of Medicine, of which he was first board member and then chairman. He served three terms on the National Heart, Lung, and Blood Advisory Council as well. He was responsible for helping establish health care systems in a host of countries, including Belgium, China, Egypt, England, Germany, Saudi Arabia, Australia, and numerous other Middle Eastern and Central and South American nations.

According to the Web site of Baylor College of Medicine’s department of surgery, where he spent almost his entire postwar career, Dr. DeBakey operated on more than 60,000 patients in the Houston area alone. But these were not all just standard operations. In 1953, he performed the first successful carotid endarterectomy, as well as the first successful removal and graft replacement of a fusiform thoracic aortic aneurysm, and in 1954, the first successful resection and graft replacement of an aneurysm of the distal aortic arch and upper descending thoracic aorta.

In 1955 he performed the first successful resection of a thoracoabdominal aortic aneurysm using the DeBakey Dacron graft—the first artificial arterial graft of its kind.

"If we now tried to develop the Dacron graft the way we developed it, I am not sure we would have it today with the way they regulate things. ...When I went down to the department store . . . they said, ‘We are fresh out of nylon, but we do have a new material called Dacron.’ I felt it, and it looked good to me. So I bought a yard of it. . . . I took this yard of Dacron cloth, I cut two sheets the width I wanted, sewed the edges on each side, and made a tube out of it. . . . We put the graft on a stent, wrapped nylon thread around it, pushed it together, and baked it. . . . After about two or three years of laboratory work on my own [including experiments in dogs], I decided that it was time to put the graft in a human being. I did not have a committee to approve it. . . . In 1954, I put the first one in during an abdominal aortic aneurysm. That first patient lived, I think, for 13 years and never had any trouble," Dr. DeBakey related in an interview published in 1996 in the Journal of Vascular Surgery.

And among his other pioneering surgical developments, in 1964, Dr. DeBakey was the first to perform a successful coronary artery bypass, using a portion of leg vein as the graft, in what is now one of the most commonly performed heart operations—coronary artery bypass grafting.

As if surgically repairing failing hearts was not enough, Dr. DeBakey became a pioneer of artificial heart research and of cardiac assist devices. On July 18, 1963, after years of animal research, he performed the first successful human implantation of a left ventricular assist device (LVAD), one which he devised; the patient died after 4 days from causes unrelated to the technology. In 1966, Dr. DeBakey’s redesigned, extracorporeal pneumatic pump was used in a 37-year-old woman who could not be weaned from the heart-lung machine after dual valve replacement. After 10 days of LVAD support, she recovered sufficiently for the pump to be removed and she survived. This pump served as the basis of Dr. DeBakey’s first total artificial heart model, created in 1968.

Dr. DeBakey was honored profusely throughout his lifetime by the medical community and the general public. Numerous medical facilities are named after him in this country and around the world. He received countless awards for his technical and social achievements in medicine. Among these honors were the American Medical Association’s Distinguished Service Award (1959), the Albert Lasker Award for Clinical Medical Research (1963), the Presidential Medal of Freedom (1969), and the National Medal of Science (1987). More recently, he was the first foreign member elected to the Russian Academy of Sciences (1999), was given the Library of Congress Bicentennial Living Legend Award (2000), and was awarded the Congressional Gold Medal in April 2008.

In his death, Dr. DeBakey was the first Houston resident given the honor of lying in state at City Hall and, at the request of his family, he lay dressed in his characteristic glasses, scrubs, and white coat for viewing by long lines of the general public.n

Sources and suggested readingsHeart Fail. Clin. 2007;3:117-20.J. Vasc. Surg. 1996;23:1031-4.

CHICAGO – The diagnostic accuracy of FDG-PET in lung cancer performed below levels described in previous reports and varied widely among U.S. centers in a secondary analysis of a large phase III clinical trial.

"FDG-PET performed poorly for diagnosing non–small cell lung cancer in a national sample of clinical stage 1 patients," Dr. Eric L. Grogan said at the annnual meeting of the of the American Society of Clinical Oncology.

The current National Comprehensive Cancer Network guidelines recommend the use of fluorodeoxyglucose positron emission tomography (FDG-PET) for the diagnosis of NSCLC based on studies showing a high degree of accuracy for this diagnostic tool, notably a sensitivity of 94% and a median specificity of 83% in a meta-analysis of 40 studies (JAMA 2001;285:914-24).

Others have reported, however, that FDG-PET performs poorly at single institutions in regions of endemic fungal lung diseases (Ann. Thor. Surg. 2011;92:428-32 and Lung Cancer 2002;36:297-301), observed Dr. Grogan, of Vanderbilt-Ingram Cancer Center in Nashville, Tenn.

Among 682 patients in the American College of Surgeons Oncology Group (ACOSOG) Z4031 trial, the overall accuracy of FDG-PET was 73%, the sensitivity 82%, and the specificity only 31%.

The series is the largest to date evaluating the accuracy of FDG-PET in patients with known or suspected clinical stage 1 NSCLC. In addition, it is generalizable to clinical practice because multiple FDG-PET scanners were used and the scans were performed in community and academic centers and interpreted by multiple radiologists, Dr. Grogan said.

"Results of PET scans in this population should be interpreted cautiously, and reasons for the poor test performance should be explored in other studies," he said.

Discussant Dr. Tetsuya Mitsudomi, who is the chief of thoracic surgery at Aichi Cancer Center Hospital in Nagoya, Japan, said FDG-PET shows reasonable sensitivity, but very low specificity compared with previous studies.

"I think this reflects the real world," he said. "So, the lung cancer diagnosis cannot be made on the basis of PET positivity alone."

Investigators at 51 sites in 39 cities enrolled 969 patients with known or clinically suspicious stage 1 lesions between 2004 and 2006 to evaluate the value of proteomic analysis in diagnosing NSCLC (the results were presented at ASCO 2010). FDG-PET scans were available for 682 patients. All underwent surgical resection. Analyses were performed for all patients and for sites with more than 25 patients.

PET avidity was determined by the radiologist’s description of lesion activity or by the reported maximum standard uptake value (SUV). Avidity was classified in four categories: category 1 was no avidity/not cancer (SUV = 0), category 2 was low avidity/not likely cancer (SUV 0 to less than 2.5), category 3 was avidity/possibly cancer (SUV 2.5 to less than 5.0), and category 4 was high avidity/likely cancer (SUV 5.0 or more).

Among the 682 patients, there were 566 cancers and 116 benign cases. In all, 82% of the cancerous lesions were PET avid, and "surprisingly, 69% of the benign lesions were avid," Dr. Grogan said.

Patients with cancer were significantly older (67 vs. 61 years; P less than .001) and had larger lesions (26 mm vs. 20 mm; P less than .001).

The positive predictive value of FDG-PET was 85% and negative predictive value 26%. This translates into 80 false positives and 101 false negatives. The majority of false positives were found to be granulomas (69%), he observed. Eleven of the false negatives were 10 mm or less.

Not surprising, FDG-PET accuracy improved with lesion size, Dr. Grogan said. The accuracy was less than 50% for lesions less than 20 mm, but greater than 80% for lesions larger than 30 mm. "Above 30 mm, the accuracy did not seem to improve," he observed.

In the eight cities that had more than 25 patients, the sensitivity varied significantly, from a low of 67% in Los Angeles to a high of 91% in Durham, N.C. (P = .03), Dr. Grogan said, without explanation. Specificity ranged from 15% in Birmingham, Ala., to 46% in Philadelphia, but this did not reach statistical significance because of the small number of benign cases at each institution (P = .72).

Dr. Mitsudomi said he could not explain the reason for the heterogeneity, especially in terms of the specificity, between centers.

"It’s not possible to remove all the false positives if you use FDG, but newer tracers are being developed and they may increase the specificity rate," he added.

Dr. Grogan reported no disclosures. Dr. Mitsudomi reported having a consulting/advisory role with Boehringer Ingelheim, Kyowa Hakko Kirin, Lilly, and Pfizer, and receiving honoraria from AstraZeneca, Chugai Pharma, Lilly, and Roche.☐

CHICAGO – The diagnostic accuracy of FDG-PET in lung cancer performed below levels described in previous reports and varied widely among U.S. centers in a secondary analysis of a large phase III clinical trial.

"FDG-PET performed poorly for diagnosing non–small cell lung cancer in a national sample of clinical stage 1 patients," Dr. Eric L. Grogan said at the annnual meeting of the of the American Society of Clinical Oncology.

The current National Comprehensive Cancer Network guidelines recommend the use of fluorodeoxyglucose positron emission tomography (FDG-PET) for the diagnosis of NSCLC based on studies showing a high degree of accuracy for this diagnostic tool, notably a sensitivity of 94% and a median specificity of 83% in a meta-analysis of 40 studies (JAMA 2001;285:914-24).

Others have reported, however, that FDG-PET performs poorly at single institutions in regions of endemic fungal lung diseases (Ann. Thor. Surg. 2011;92:428-32 and Lung Cancer 2002;36:297-301), observed Dr. Grogan, of Vanderbilt-Ingram Cancer Center in Nashville, Tenn.

Among 682 patients in the American College of Surgeons Oncology Group (ACOSOG) Z4031 trial, the overall accuracy of FDG-PET was 73%, the sensitivity 82%, and the specificity only 31%.

The series is the largest to date evaluating the accuracy of FDG-PET in patients with known or suspected clinical stage 1 NSCLC. In addition, it is generalizable to clinical practice because multiple FDG-PET scanners were used and the scans were performed in community and academic centers and interpreted by multiple radiologists, Dr. Grogan said.

"Results of PET scans in this population should be interpreted cautiously, and reasons for the poor test performance should be explored in other studies," he said.

Discussant Dr. Tetsuya Mitsudomi, who is the chief of thoracic surgery at Aichi Cancer Center Hospital in Nagoya, Japan, said FDG-PET shows reasonable sensitivity, but very low specificity compared with previous studies.

"I think this reflects the real world," he said. "So, the lung cancer diagnosis cannot be made on the basis of PET positivity alone."

Investigators at 51 sites in 39 cities enrolled 969 patients with known or clinically suspicious stage 1 lesions between 2004 and 2006 to evaluate the value of proteomic analysis in diagnosing NSCLC (the results were presented at ASCO 2010). FDG-PET scans were available for 682 patients. All underwent surgical resection. Analyses were performed for all patients and for sites with more than 25 patients.

PET avidity was determined by the radiologist’s description of lesion activity or by the reported maximum standard uptake value (SUV). Avidity was classified in four categories: category 1 was no avidity/not cancer (SUV = 0), category 2 was low avidity/not likely cancer (SUV 0 to less than 2.5), category 3 was avidity/possibly cancer (SUV 2.5 to less than 5.0), and category 4 was high avidity/likely cancer (SUV 5.0 or more).

Among the 682 patients, there were 566 cancers and 116 benign cases. In all, 82% of the cancerous lesions were PET avid, and "surprisingly, 69% of the benign lesions were avid," Dr. Grogan said.

Patients with cancer were significantly older (67 vs. 61 years; P less than .001) and had larger lesions (26 mm vs. 20 mm; P less than .001).

The positive predictive value of FDG-PET was 85% and negative predictive value 26%. This translates into 80 false positives and 101 false negatives. The majority of false positives were found to be granulomas (69%), he observed. Eleven of the false negatives were 10 mm or less.

Not surprising, FDG-PET accuracy improved with lesion size, Dr. Grogan said. The accuracy was less than 50% for lesions less than 20 mm, but greater than 80% for lesions larger than 30 mm. "Above 30 mm, the accuracy did not seem to improve," he observed.

In the eight cities that had more than 25 patients, the sensitivity varied significantly, from a low of 67% in Los Angeles to a high of 91% in Durham, N.C. (P = .03), Dr. Grogan said, without explanation. Specificity ranged from 15% in Birmingham, Ala., to 46% in Philadelphia, but this did not reach statistical significance because of the small number of benign cases at each institution (P = .72).

Dr. Mitsudomi said he could not explain the reason for the heterogeneity, especially in terms of the specificity, between centers.

"It’s not possible to remove all the false positives if you use FDG, but newer tracers are being developed and they may increase the specificity rate," he added.

Dr. Grogan reported no disclosures. Dr. Mitsudomi reported having a consulting/advisory role with Boehringer Ingelheim, Kyowa Hakko Kirin, Lilly, and Pfizer, and receiving honoraria from AstraZeneca, Chugai Pharma, Lilly, and Roche.☐

CHICAGO – The diagnostic accuracy of FDG-PET in lung cancer performed below levels described in previous reports and varied widely among U.S. centers in a secondary analysis of a large phase III clinical trial.

"FDG-PET performed poorly for diagnosing non–small cell lung cancer in a national sample of clinical stage 1 patients," Dr. Eric L. Grogan said at the annnual meeting of the of the American Society of Clinical Oncology.

The current National Comprehensive Cancer Network guidelines recommend the use of fluorodeoxyglucose positron emission tomography (FDG-PET) for the diagnosis of NSCLC based on studies showing a high degree of accuracy for this diagnostic tool, notably a sensitivity of 94% and a median specificity of 83% in a meta-analysis of 40 studies (JAMA 2001;285:914-24).

Others have reported, however, that FDG-PET performs poorly at single institutions in regions of endemic fungal lung diseases (Ann. Thor. Surg. 2011;92:428-32 and Lung Cancer 2002;36:297-301), observed Dr. Grogan, of Vanderbilt-Ingram Cancer Center in Nashville, Tenn.

Among 682 patients in the American College of Surgeons Oncology Group (ACOSOG) Z4031 trial, the overall accuracy of FDG-PET was 73%, the sensitivity 82%, and the specificity only 31%.

The series is the largest to date evaluating the accuracy of FDG-PET in patients with known or suspected clinical stage 1 NSCLC. In addition, it is generalizable to clinical practice because multiple FDG-PET scanners were used and the scans were performed in community and academic centers and interpreted by multiple radiologists, Dr. Grogan said.

"Results of PET scans in this population should be interpreted cautiously, and reasons for the poor test performance should be explored in other studies," he said.

Discussant Dr. Tetsuya Mitsudomi, who is the chief of thoracic surgery at Aichi Cancer Center Hospital in Nagoya, Japan, said FDG-PET shows reasonable sensitivity, but very low specificity compared with previous studies.

"I think this reflects the real world," he said. "So, the lung cancer diagnosis cannot be made on the basis of PET positivity alone."

Investigators at 51 sites in 39 cities enrolled 969 patients with known or clinically suspicious stage 1 lesions between 2004 and 2006 to evaluate the value of proteomic analysis in diagnosing NSCLC (the results were presented at ASCO 2010). FDG-PET scans were available for 682 patients. All underwent surgical resection. Analyses were performed for all patients and for sites with more than 25 patients.

PET avidity was determined by the radiologist’s description of lesion activity or by the reported maximum standard uptake value (SUV). Avidity was classified in four categories: category 1 was no avidity/not cancer (SUV = 0), category 2 was low avidity/not likely cancer (SUV 0 to less than 2.5), category 3 was avidity/possibly cancer (SUV 2.5 to less than 5.0), and category 4 was high avidity/likely cancer (SUV 5.0 or more).

Among the 682 patients, there were 566 cancers and 116 benign cases. In all, 82% of the cancerous lesions were PET avid, and "surprisingly, 69% of the benign lesions were avid," Dr. Grogan said.

Patients with cancer were significantly older (67 vs. 61 years; P less than .001) and had larger lesions (26 mm vs. 20 mm; P less than .001).

The positive predictive value of FDG-PET was 85% and negative predictive value 26%. This translates into 80 false positives and 101 false negatives. The majority of false positives were found to be granulomas (69%), he observed. Eleven of the false negatives were 10 mm or less.

Not surprising, FDG-PET accuracy improved with lesion size, Dr. Grogan said. The accuracy was less than 50% for lesions less than 20 mm, but greater than 80% for lesions larger than 30 mm. "Above 30 mm, the accuracy did not seem to improve," he observed.

In the eight cities that had more than 25 patients, the sensitivity varied significantly, from a low of 67% in Los Angeles to a high of 91% in Durham, N.C. (P = .03), Dr. Grogan said, without explanation. Specificity ranged from 15% in Birmingham, Ala., to 46% in Philadelphia, but this did not reach statistical significance because of the small number of benign cases at each institution (P = .72).

Dr. Mitsudomi said he could not explain the reason for the heterogeneity, especially in terms of the specificity, between centers.

"It’s not possible to remove all the false positives if you use FDG, but newer tracers are being developed and they may increase the specificity rate," he added.

Dr. Grogan reported no disclosures. Dr. Mitsudomi reported having a consulting/advisory role with Boehringer Ingelheim, Kyowa Hakko Kirin, Lilly, and Pfizer, and receiving honoraria from AstraZeneca, Chugai Pharma, Lilly, and Roche.☐

SAN FRANCISCO – Thoracic surgeons should not shy away from segmentectomy in select patients with NSCLC, an expert advises, because the technique confers specific advantages.

In addition, it is as feasible as lobectomy. "If you can do a lobectomy, you can do a segmentectomy. There is no doubt about it," Dr. Matthew J. Schuchert said at the annual meeting of the American Association for Thoracic Surgery.

He shared patient selection criteria and technique tips based on experience with the more than 800 segmentectomies performed at the University of Pittsburgh Medical Center/UPMC Cancer Institute, where he is a general and thoracic surgeon.

Anatomic segmentectomy accomplishes the fundamental surgical tenets achieved by lobectomy, including R0 resection, adequate margins, and an opportunity for systematic nodal staging in early lung cancer, Dr. Schuchert said.

Lung preservation is another potential benefit of segmentectomy and the procedure is particularly useful for tumors with low malignancy potential where you may not have to take out an entire lobe to gain oncologic control, he said.

Equivalent survival to lobectomy has been demonstrated for stage 1A disease, especially for lesions smaller than 2 cm. In addition, "there may be decreased morbidity and mortality risk, especially among the elderly, a population we are going to be seeing more and more of."

Patient selection is paramount. In addition to the elderly, segmentectomy is particularly suitable for patients with marginal pulmonary function; those with "ground glass opacity" that may have low nodal positivity rates; and those who had prior lobectomy seeking parenchymal preservation.

"If you are contemplating the use of segmentectomy, it all really comes down to evaluation of the case," he said. Preoperative imaging ideally reveals a small tumor (less than 2 cm) in the outer one third of the lung. In addition, tumors should be confined to a discrete segmental boundary. "That’s critical. That’s the ticket for success," he said.

Surgeons can use the same anatomic approach they employ for lobectomy, only direct it at one segment. It is important to know segmental vascular and segmental bronchial anatomy, Dr. Schuchert noted.

"All of the same anatomic concerns, exposure concerns, and dissection concerns and techniques really apply." Segmentectomy can be performed through video-assisted thoracic surgery (VATS) or an open approach; the majority of cases at the University of Pittsburgh are VATS.

"We typically position the camera at about the seventh interspace in the mid-axillary line. Along the same interspace, a little more posteriorly, we will utilize a 10-mm incision for retraction and stapling. The access incision is pretty much the same as it is for a VATS lobectomy, usually somewhere along the line of the inframammary crease, and we place it right over the anterior hilum." This incision is usually around the level of the minor fissure on the right and slightly above the major fissure on the left, he added. Next, a 5-mm incision is made for retraction; it can also be particularly useful during node dissection, Dr. Schuchert said.

Preservation of the remaining lung is always a goal. "If you devitalize the remaining lung or impinge upon the bronchial supply, that patient is going to be doomed to have some perioperative issues." Remember that segmentectomy is a functional operation as well, he pointed out. "We are not just taking things out; what we leave behind still has to work."

Dissection assisted by an energy device is a more recent development in their hands. "We have now utilized energy in well over 100 patients undergoing both segmentectomy and lobectomy," he said.

Another essential goal of segmentectomy is to achieve a margin-to-tumor ratio greater than the size of the tumor itself, he said. As an example, he cited the case of a 71-year-old man with a history of diverticulitis with a pulmonary nodule picked up on an abdominal CT scan. The nodule was 1.7 cm, well confined in the outer third of the lung, and well centered within the basilar segment. Fine-needle aspiration of the nodule revealed adenocarcinoma. "He was considered to be an excellent candidate for segmentectomy. In this case, the margin was about 5 cm for a 1.7-cm tumor."

He and his colleagues published additional details of the segmentectomies they performed between 2002 and 2010 at UPMC in a retrospective study (Ann. Thorac. Surg. 2012:93:1780-7).

He said that he had no disclosures.

SAN FRANCISCO – Thoracic surgeons should not shy away from segmentectomy in select patients with NSCLC, an expert advises, because the technique confers specific advantages.

In addition, it is as feasible as lobectomy. "If you can do a lobectomy, you can do a segmentectomy. There is no doubt about it," Dr. Matthew J. Schuchert said at the annual meeting of the American Association for Thoracic Surgery.

He shared patient selection criteria and technique tips based on experience with the more than 800 segmentectomies performed at the University of Pittsburgh Medical Center/UPMC Cancer Institute, where he is a general and thoracic surgeon.

Anatomic segmentectomy accomplishes the fundamental surgical tenets achieved by lobectomy, including R0 resection, adequate margins, and an opportunity for systematic nodal staging in early lung cancer, Dr. Schuchert said.

Lung preservation is another potential benefit of segmentectomy and the procedure is particularly useful for tumors with low malignancy potential where you may not have to take out an entire lobe to gain oncologic control, he said.

Equivalent survival to lobectomy has been demonstrated for stage 1A disease, especially for lesions smaller than 2 cm. In addition, "there may be decreased morbidity and mortality risk, especially among the elderly, a population we are going to be seeing more and more of."

Patient selection is paramount. In addition to the elderly, segmentectomy is particularly suitable for patients with marginal pulmonary function; those with "ground glass opacity" that may have low nodal positivity rates; and those who had prior lobectomy seeking parenchymal preservation.

"If you are contemplating the use of segmentectomy, it all really comes down to evaluation of the case," he said. Preoperative imaging ideally reveals a small tumor (less than 2 cm) in the outer one third of the lung. In addition, tumors should be confined to a discrete segmental boundary. "That’s critical. That’s the ticket for success," he said.

Surgeons can use the same anatomic approach they employ for lobectomy, only direct it at one segment. It is important to know segmental vascular and segmental bronchial anatomy, Dr. Schuchert noted.

"All of the same anatomic concerns, exposure concerns, and dissection concerns and techniques really apply." Segmentectomy can be performed through video-assisted thoracic surgery (VATS) or an open approach; the majority of cases at the University of Pittsburgh are VATS.

"We typically position the camera at about the seventh interspace in the mid-axillary line. Along the same interspace, a little more posteriorly, we will utilize a 10-mm incision for retraction and stapling. The access incision is pretty much the same as it is for a VATS lobectomy, usually somewhere along the line of the inframammary crease, and we place it right over the anterior hilum." This incision is usually around the level of the minor fissure on the right and slightly above the major fissure on the left, he added. Next, a 5-mm incision is made for retraction; it can also be particularly useful during node dissection, Dr. Schuchert said.

Preservation of the remaining lung is always a goal. "If you devitalize the remaining lung or impinge upon the bronchial supply, that patient is going to be doomed to have some perioperative issues." Remember that segmentectomy is a functional operation as well, he pointed out. "We are not just taking things out; what we leave behind still has to work."

Dissection assisted by an energy device is a more recent development in their hands. "We have now utilized energy in well over 100 patients undergoing both segmentectomy and lobectomy," he said.

Another essential goal of segmentectomy is to achieve a margin-to-tumor ratio greater than the size of the tumor itself, he said. As an example, he cited the case of a 71-year-old man with a history of diverticulitis with a pulmonary nodule picked up on an abdominal CT scan. The nodule was 1.7 cm, well confined in the outer third of the lung, and well centered within the basilar segment. Fine-needle aspiration of the nodule revealed adenocarcinoma. "He was considered to be an excellent candidate for segmentectomy. In this case, the margin was about 5 cm for a 1.7-cm tumor."

He and his colleagues published additional details of the segmentectomies they performed between 2002 and 2010 at UPMC in a retrospective study (Ann. Thorac. Surg. 2012:93:1780-7).

He said that he had no disclosures.

SAN FRANCISCO – Thoracic surgeons should not shy away from segmentectomy in select patients with NSCLC, an expert advises, because the technique confers specific advantages.

In addition, it is as feasible as lobectomy. "If you can do a lobectomy, you can do a segmentectomy. There is no doubt about it," Dr. Matthew J. Schuchert said at the annual meeting of the American Association for Thoracic Surgery.

He shared patient selection criteria and technique tips based on experience with the more than 800 segmentectomies performed at the University of Pittsburgh Medical Center/UPMC Cancer Institute, where he is a general and thoracic surgeon.

Anatomic segmentectomy accomplishes the fundamental surgical tenets achieved by lobectomy, including R0 resection, adequate margins, and an opportunity for systematic nodal staging in early lung cancer, Dr. Schuchert said.

Lung preservation is another potential benefit of segmentectomy and the procedure is particularly useful for tumors with low malignancy potential where you may not have to take out an entire lobe to gain oncologic control, he said.

Equivalent survival to lobectomy has been demonstrated for stage 1A disease, especially for lesions smaller than 2 cm. In addition, "there may be decreased morbidity and mortality risk, especially among the elderly, a population we are going to be seeing more and more of."

Patient selection is paramount. In addition to the elderly, segmentectomy is particularly suitable for patients with marginal pulmonary function; those with "ground glass opacity" that may have low nodal positivity rates; and those who had prior lobectomy seeking parenchymal preservation.

"If you are contemplating the use of segmentectomy, it all really comes down to evaluation of the case," he said. Preoperative imaging ideally reveals a small tumor (less than 2 cm) in the outer one third of the lung. In addition, tumors should be confined to a discrete segmental boundary. "That’s critical. That’s the ticket for success," he said.

Surgeons can use the same anatomic approach they employ for lobectomy, only direct it at one segment. It is important to know segmental vascular and segmental bronchial anatomy, Dr. Schuchert noted.

"All of the same anatomic concerns, exposure concerns, and dissection concerns and techniques really apply." Segmentectomy can be performed through video-assisted thoracic surgery (VATS) or an open approach; the majority of cases at the University of Pittsburgh are VATS.

"We typically position the camera at about the seventh interspace in the mid-axillary line. Along the same interspace, a little more posteriorly, we will utilize a 10-mm incision for retraction and stapling. The access incision is pretty much the same as it is for a VATS lobectomy, usually somewhere along the line of the inframammary crease, and we place it right over the anterior hilum." This incision is usually around the level of the minor fissure on the right and slightly above the major fissure on the left, he added. Next, a 5-mm incision is made for retraction; it can also be particularly useful during node dissection, Dr. Schuchert said.

Preservation of the remaining lung is always a goal. "If you devitalize the remaining lung or impinge upon the bronchial supply, that patient is going to be doomed to have some perioperative issues." Remember that segmentectomy is a functional operation as well, he pointed out. "We are not just taking things out; what we leave behind still has to work."

Dissection assisted by an energy device is a more recent development in their hands. "We have now utilized energy in well over 100 patients undergoing both segmentectomy and lobectomy," he said.

Another essential goal of segmentectomy is to achieve a margin-to-tumor ratio greater than the size of the tumor itself, he said. As an example, he cited the case of a 71-year-old man with a history of diverticulitis with a pulmonary nodule picked up on an abdominal CT scan. The nodule was 1.7 cm, well confined in the outer third of the lung, and well centered within the basilar segment. Fine-needle aspiration of the nodule revealed adenocarcinoma. "He was considered to be an excellent candidate for segmentectomy. In this case, the margin was about 5 cm for a 1.7-cm tumor."

He and his colleagues published additional details of the segmentectomies they performed between 2002 and 2010 at UPMC in a retrospective study (Ann. Thorac. Surg. 2012:93:1780-7).

He said that he had no disclosures.

CHICAGO – The diagnostic accuracy of FDG-PET in lung cancer performed below levels described in previous reports and varied widely among U.S. centers in a secondary analysis of a large phase III clinical trial.

"FDG-PET performed poorly for diagnosing non–small cell lung cancer in a national sample of clinical stage 1 patients," Dr. Eric L. Grogan said at the annnual meeting of the of the American Society of Clinical Oncology.

The current National Comprehensive Cancer Network guidelines recommend the use of fluorodeoxyglucose positron emission tomography (FDG-PET) for the diagnosis of NSCLC based on studies showing a high degree of accuracy for this diagnostic tool, notably a sensitivity of 94% and a median specificity of 83% in a meta-analysis of 40 studies (JAMA 2001;285:914-24).

Others have reported, however, that FDG-PET performs poorly at single institutions in regions of endemic fungal lung diseases (Ann. Thor. Surg. 2011;92:428-32 and Lung Cancer 2002;36:297-301), observed Dr. Grogan, of Vanderbilt-Ingram Cancer Center in Nashville, Tenn.

Among 682 patients in the American College of Surgeons Oncology Group (ACOSOG) Z4031 trial, the overall accuracy of FDG-PET was 73%, the sensitivity 82%, and the specificity only 31%.

The series is the largest to date evaluating the accuracy of FDG-PET in patients with known or suspected clinical stage 1 NSCLC. In addition, it is generalizable to clinical practice because multiple FDG-PET scanners were used and the scans were performed in community and academic centers and interpreted by multiple radiologists, Dr. Grogan said.

"Results of PET scans in this population should be interpreted cautiously, and reasons for the poor test performance should be explored in other studies," he said.

Discussant Dr. Tetsuya Mitsudomi, who is the chief of thoracic surgery at Aichi Cancer Center Hospital in Nagoya, Japan, said FDG-PET shows reasonable sensitivity, but very low specificity compared with previous studies.

"I think this reflects the real world," he said. "So, the lung cancer diagnosis cannot be made on the basis of PET positivity alone."

Investigators at 51 sites in 39 cities enrolled 969 patients with known or clinically suspicious stage 1 lesions between 2004 and 2006 to evaluate the value of proteomic analysis in diagnosing NSCLC (the results were presented at ASCO 2010). FDG-PET scans were available for 682 patients. All underwent surgical resection. Analyses were performed for all patients and for sites with more than 25 patients.

PET avidity was determined by the radiologist’s description of lesion activity or by the reported maximum standard uptake value (SUV). Avidity was classified in four categories: category 1 was no avidity/not cancer (SUV = 0), category 2 was low avidity/not likely cancer (SUV 0 to less than 2.5), category 3 was avidity/possibly cancer (SUV 2.5 to less than 5.0), and category 4 was high avidity/likely cancer (SUV 5.0 or more).

Among the 682 patients, there were 566 cancers and 116 benign cases. In all, 82% of the cancerous lesions were PET avid, and "surprisingly, 69% of the benign lesions were avid," Dr. Grogan said.

Patients with cancer were significantly older (67 vs. 61 years; P less than .001) and had larger lesions (26 mm vs. 20 mm; P less than .001).

The positive predictive value of FDG-PET was 85% and negative predictive value 26%. This translates into 80 false positives and 101 false negatives. The majority of false positives were found to be granulomas (69%), he observed. Eleven of the false negatives were 10 mm or less.

Not surprising, FDG-PET accuracy improved with lesion size, Dr. Grogan said. The accuracy was less than 50% for lesions less than 20 mm, but greater than 80% for lesions larger than 30 mm. "Above 30 mm, the accuracy did not seem to improve," he observed.

In the eight cities that had more than 25 patients, the sensitivity varied significantly, from a low of 67% in Los Angeles to a high of 91% in Durham, N.C. (P = .03), Dr. Grogan said, without explanation. Specificity ranged from 15% in Birmingham, Ala., to 46% in Philadelphia, but this did not reach statistical significance because of the small number of benign cases at each institution (P = .72).

Dr. Mitsudomi said he could not explain the reason for the heterogeneity, especially in terms of the specificity, between centers.

"It’s not possible to remove all the false positives if you use FDG, but newer tracers are being developed and they may increase the specificity rate," he added.

Dr. Grogan reported no disclosures. Dr. Mitsudomi reported having a consulting/advisory role with Boehringer Ingelheim, Kyowa Hakko Kirin, Lilly, and Pfizer, and receiving honoraria from AstraZeneca, Chugai Pharma, Lilly, and Roche.☐

CHICAGO – The diagnostic accuracy of FDG-PET in lung cancer performed below levels described in previous reports and varied widely among U.S. centers in a secondary analysis of a large phase III clinical trial.

"FDG-PET performed poorly for diagnosing non–small cell lung cancer in a national sample of clinical stage 1 patients," Dr. Eric L. Grogan said at the annnual meeting of the of the American Society of Clinical Oncology.

The current National Comprehensive Cancer Network guidelines recommend the use of fluorodeoxyglucose positron emission tomography (FDG-PET) for the diagnosis of NSCLC based on studies showing a high degree of accuracy for this diagnostic tool, notably a sensitivity of 94% and a median specificity of 83% in a meta-analysis of 40 studies (JAMA 2001;285:914-24).

Others have reported, however, that FDG-PET performs poorly at single institutions in regions of endemic fungal lung diseases (Ann. Thor. Surg. 2011;92:428-32 and Lung Cancer 2002;36:297-301), observed Dr. Grogan, of Vanderbilt-Ingram Cancer Center in Nashville, Tenn.

Among 682 patients in the American College of Surgeons Oncology Group (ACOSOG) Z4031 trial, the overall accuracy of FDG-PET was 73%, the sensitivity 82%, and the specificity only 31%.

The series is the largest to date evaluating the accuracy of FDG-PET in patients with known or suspected clinical stage 1 NSCLC. In addition, it is generalizable to clinical practice because multiple FDG-PET scanners were used and the scans were performed in community and academic centers and interpreted by multiple radiologists, Dr. Grogan said.

"Results of PET scans in this population should be interpreted cautiously, and reasons for the poor test performance should be explored in other studies," he said.

Discussant Dr. Tetsuya Mitsudomi, who is the chief of thoracic surgery at Aichi Cancer Center Hospital in Nagoya, Japan, said FDG-PET shows reasonable sensitivity, but very low specificity compared with previous studies.

"I think this reflects the real world," he said. "So, the lung cancer diagnosis cannot be made on the basis of PET positivity alone."

Investigators at 51 sites in 39 cities enrolled 969 patients with known or clinically suspicious stage 1 lesions between 2004 and 2006 to evaluate the value of proteomic analysis in diagnosing NSCLC (the results were presented at ASCO 2010). FDG-PET scans were available for 682 patients. All underwent surgical resection. Analyses were performed for all patients and for sites with more than 25 patients.

PET avidity was determined by the radiologist’s description of lesion activity or by the reported maximum standard uptake value (SUV). Avidity was classified in four categories: category 1 was no avidity/not cancer (SUV = 0), category 2 was low avidity/not likely cancer (SUV 0 to less than 2.5), category 3 was avidity/possibly cancer (SUV 2.5 to less than 5.0), and category 4 was high avidity/likely cancer (SUV 5.0 or more).

Among the 682 patients, there were 566 cancers and 116 benign cases. In all, 82% of the cancerous lesions were PET avid, and "surprisingly, 69% of the benign lesions were avid," Dr. Grogan said.

Patients with cancer were significantly older (67 vs. 61 years; P less than .001) and had larger lesions (26 mm vs. 20 mm; P less than .001).

The positive predictive value of FDG-PET was 85% and negative predictive value 26%. This translates into 80 false positives and 101 false negatives. The majority of false positives were found to be granulomas (69%), he observed. Eleven of the false negatives were 10 mm or less.

Not surprising, FDG-PET accuracy improved with lesion size, Dr. Grogan said. The accuracy was less than 50% for lesions less than 20 mm, but greater than 80% for lesions larger than 30 mm. "Above 30 mm, the accuracy did not seem to improve," he observed.

In the eight cities that had more than 25 patients, the sensitivity varied significantly, from a low of 67% in Los Angeles to a high of 91% in Durham, N.C. (P = .03), Dr. Grogan said, without explanation. Specificity ranged from 15% in Birmingham, Ala., to 46% in Philadelphia, but this did not reach statistical significance because of the small number of benign cases at each institution (P = .72).

Dr. Mitsudomi said he could not explain the reason for the heterogeneity, especially in terms of the specificity, between centers.

"It’s not possible to remove all the false positives if you use FDG, but newer tracers are being developed and they may increase the specificity rate," he added.

Dr. Grogan reported no disclosures. Dr. Mitsudomi reported having a consulting/advisory role with Boehringer Ingelheim, Kyowa Hakko Kirin, Lilly, and Pfizer, and receiving honoraria from AstraZeneca, Chugai Pharma, Lilly, and Roche.☐

CHICAGO – The diagnostic accuracy of FDG-PET in lung cancer performed below levels described in previous reports and varied widely among U.S. centers in a secondary analysis of a large phase III clinical trial.

"FDG-PET performed poorly for diagnosing non–small cell lung cancer in a national sample of clinical stage 1 patients," Dr. Eric L. Grogan said at the annnual meeting of the of the American Society of Clinical Oncology.

The current National Comprehensive Cancer Network guidelines recommend the use of fluorodeoxyglucose positron emission tomography (FDG-PET) for the diagnosis of NSCLC based on studies showing a high degree of accuracy for this diagnostic tool, notably a sensitivity of 94% and a median specificity of 83% in a meta-analysis of 40 studies (JAMA 2001;285:914-24).

Others have reported, however, that FDG-PET performs poorly at single institutions in regions of endemic fungal lung diseases (Ann. Thor. Surg. 2011;92:428-32 and Lung Cancer 2002;36:297-301), observed Dr. Grogan, of Vanderbilt-Ingram Cancer Center in Nashville, Tenn.

Among 682 patients in the American College of Surgeons Oncology Group (ACOSOG) Z4031 trial, the overall accuracy of FDG-PET was 73%, the sensitivity 82%, and the specificity only 31%.

The series is the largest to date evaluating the accuracy of FDG-PET in patients with known or suspected clinical stage 1 NSCLC. In addition, it is generalizable to clinical practice because multiple FDG-PET scanners were used and the scans were performed in community and academic centers and interpreted by multiple radiologists, Dr. Grogan said.

"Results of PET scans in this population should be interpreted cautiously, and reasons for the poor test performance should be explored in other studies," he said.

Discussant Dr. Tetsuya Mitsudomi, who is the chief of thoracic surgery at Aichi Cancer Center Hospital in Nagoya, Japan, said FDG-PET shows reasonable sensitivity, but very low specificity compared with previous studies.

"I think this reflects the real world," he said. "So, the lung cancer diagnosis cannot be made on the basis of PET positivity alone."

Investigators at 51 sites in 39 cities enrolled 969 patients with known or clinically suspicious stage 1 lesions between 2004 and 2006 to evaluate the value of proteomic analysis in diagnosing NSCLC (the results were presented at ASCO 2010). FDG-PET scans were available for 682 patients. All underwent surgical resection. Analyses were performed for all patients and for sites with more than 25 patients.

PET avidity was determined by the radiologist’s description of lesion activity or by the reported maximum standard uptake value (SUV). Avidity was classified in four categories: category 1 was no avidity/not cancer (SUV = 0), category 2 was low avidity/not likely cancer (SUV 0 to less than 2.5), category 3 was avidity/possibly cancer (SUV 2.5 to less than 5.0), and category 4 was high avidity/likely cancer (SUV 5.0 or more).

Among the 682 patients, there were 566 cancers and 116 benign cases. In all, 82% of the cancerous lesions were PET avid, and "surprisingly, 69% of the benign lesions were avid," Dr. Grogan said.

Patients with cancer were significantly older (67 vs. 61 years; P less than .001) and had larger lesions (26 mm vs. 20 mm; P less than .001).

The positive predictive value of FDG-PET was 85% and negative predictive value 26%. This translates into 80 false positives and 101 false negatives. The majority of false positives were found to be granulomas (69%), he observed. Eleven of the false negatives were 10 mm or less.

Not surprising, FDG-PET accuracy improved with lesion size, Dr. Grogan said. The accuracy was less than 50% for lesions less than 20 mm, but greater than 80% for lesions larger than 30 mm. "Above 30 mm, the accuracy did not seem to improve," he observed.

In the eight cities that had more than 25 patients, the sensitivity varied significantly, from a low of 67% in Los Angeles to a high of 91% in Durham, N.C. (P = .03), Dr. Grogan said, without explanation. Specificity ranged from 15% in Birmingham, Ala., to 46% in Philadelphia, but this did not reach statistical significance because of the small number of benign cases at each institution (P = .72).

Dr. Mitsudomi said he could not explain the reason for the heterogeneity, especially in terms of the specificity, between centers.

"It’s not possible to remove all the false positives if you use FDG, but newer tracers are being developed and they may increase the specificity rate," he added.

Dr. Grogan reported no disclosures. Dr. Mitsudomi reported having a consulting/advisory role with Boehringer Ingelheim, Kyowa Hakko Kirin, Lilly, and Pfizer, and receiving honoraria from AstraZeneca, Chugai Pharma, Lilly, and Roche.☐

SAN FRANCISCO – Thoracic surgeons should not shy away from segmentectomy in select patients with NSCLC, an expert advises, because the technique confers specific advantages.

In addition, it is as feasible as lobectomy. "If you can do a lobectomy, you can do a segmentectomy. There is no doubt about it," Dr. Matthew J. Schuchert said at the annual meeting of the American Association for Thoracic Surgery.

He shared patient selection criteria and technique tips based on experience with the more than 800 segmentectomies performed at the University of Pittsburgh Medical Center/UPMC Cancer Institute, where he is a general and thoracic surgeon.

Anatomic segmentectomy accomplishes the fundamental surgical tenets achieved by lobectomy, including R0 resection, adequate margins, and an opportunity for systematic nodal staging in early lung cancer, Dr. Schuchert said.

Lung preservation is another potential benefit of segmentectomy and the procedure is particularly useful for tumors with low malignancy potential where you may not have to take out an entire lobe to gain oncologic control, he said.

Equivalent survival to lobectomy has been demonstrated for stage 1A disease, especially for lesions smaller than 2 cm. In addition, "there may be decreased morbidity and mortality risk, especially among the elderly, a population we are going to be seeing more and more of."

Patient selection is paramount. In addition to the elderly, segmentectomy is particularly suitable for patients with marginal pulmonary function; those with "ground glass opacity" that may have low nodal positivity rates; and those who had prior lobectomy seeking parenchymal preservation.

"If you are contemplating the use of segmentectomy, it all really comes down to evaluation of the case," he said. Preoperative imaging ideally reveals a small tumor (less than 2 cm) in the outer one third of the lung. In addition, tumors should be confined to a discrete segmental boundary. "That’s critical. That’s the ticket for success," he said.

Surgeons can use the same anatomic approach they employ for lobectomy, only direct it at one segment. It is important to know segmental vascular and segmental bronchial anatomy, Dr. Schuchert noted.

"All of the same anatomic concerns, exposure concerns, and dissection concerns and techniques really apply." Segmentectomy can be performed through video-assisted thoracic surgery (VATS) or an open approach; the majority of cases at the University of Pittsburgh are VATS.

"We typically position the camera at about the seventh interspace in the mid-axillary line. Along the same interspace, a little more posteriorly, we will utilize a 10-mm incision for retraction and stapling. The access incision is pretty much the same as it is for a VATS lobectomy, usually somewhere along the line of the inframammary crease, and we place it right over the anterior hilum." This incision is usually around the level of the minor fissure on the right and slightly above the major fissure on the left, he added. Next, a 5-mm incision is made for retraction; it can also be particularly useful during node dissection, Dr. Schuchert said.

Preservation of the remaining lung is always a goal. "If you devitalize the remaining lung or impinge upon the bronchial supply, that patient is going to be doomed to have some perioperative issues." Remember that segmentectomy is a functional operation as well, he pointed out. "We are not just taking things out; what we leave behind still has to work."

Dissection assisted by an energy device is a more recent development in their hands. "We have now utilized energy in well over 100 patients undergoing both segmentectomy and lobectomy," he said.

Another essential goal of segmentectomy is to achieve a margin-to-tumor ratio greater than the size of the tumor itself, he said. As an example, he cited the case of a 71-year-old man with a history of diverticulitis with a pulmonary nodule picked up on an abdominal CT scan. The nodule was 1.7 cm, well confined in the outer third of the lung, and well centered within the basilar segment. Fine-needle aspiration of the nodule revealed adenocarcinoma. "He was considered to be an excellent candidate for segmentectomy. In this case, the margin was about 5 cm for a 1.7-cm tumor."

He and his colleagues published additional details of the segmentectomies they performed between 2002 and 2010 at UPMC in a retrospective study (Ann. Thorac. Surg. 2012:93:1780-7).

He said that he had no disclosures.

SAN FRANCISCO – Thoracic surgeons should not shy away from segmentectomy in select patients with NSCLC, an expert advises, because the technique confers specific advantages.

In addition, it is as feasible as lobectomy. "If you can do a lobectomy, you can do a segmentectomy. There is no doubt about it," Dr. Matthew J. Schuchert said at the annual meeting of the American Association for Thoracic Surgery.

He shared patient selection criteria and technique tips based on experience with the more than 800 segmentectomies performed at the University of Pittsburgh Medical Center/UPMC Cancer Institute, where he is a general and thoracic surgeon.

Anatomic segmentectomy accomplishes the fundamental surgical tenets achieved by lobectomy, including R0 resection, adequate margins, and an opportunity for systematic nodal staging in early lung cancer, Dr. Schuchert said.

Lung preservation is another potential benefit of segmentectomy and the procedure is particularly useful for tumors with low malignancy potential where you may not have to take out an entire lobe to gain oncologic control, he said.

Equivalent survival to lobectomy has been demonstrated for stage 1A disease, especially for lesions smaller than 2 cm. In addition, "there may be decreased morbidity and mortality risk, especially among the elderly, a population we are going to be seeing more and more of."

Patient selection is paramount. In addition to the elderly, segmentectomy is particularly suitable for patients with marginal pulmonary function; those with "ground glass opacity" that may have low nodal positivity rates; and those who had prior lobectomy seeking parenchymal preservation.

"If you are contemplating the use of segmentectomy, it all really comes down to evaluation of the case," he said. Preoperative imaging ideally reveals a small tumor (less than 2 cm) in the outer one third of the lung. In addition, tumors should be confined to a discrete segmental boundary. "That’s critical. That’s the ticket for success," he said.

Surgeons can use the same anatomic approach they employ for lobectomy, only direct it at one segment. It is important to know segmental vascular and segmental bronchial anatomy, Dr. Schuchert noted.

"All of the same anatomic concerns, exposure concerns, and dissection concerns and techniques really apply." Segmentectomy can be performed through video-assisted thoracic surgery (VATS) or an open approach; the majority of cases at the University of Pittsburgh are VATS.

"We typically position the camera at about the seventh interspace in the mid-axillary line. Along the same interspace, a little more posteriorly, we will utilize a 10-mm incision for retraction and stapling. The access incision is pretty much the same as it is for a VATS lobectomy, usually somewhere along the line of the inframammary crease, and we place it right over the anterior hilum." This incision is usually around the level of the minor fissure on the right and slightly above the major fissure on the left, he added. Next, a 5-mm incision is made for retraction; it can also be particularly useful during node dissection, Dr. Schuchert said.

Preservation of the remaining lung is always a goal. "If you devitalize the remaining lung or impinge upon the bronchial supply, that patient is going to be doomed to have some perioperative issues." Remember that segmentectomy is a functional operation as well, he pointed out. "We are not just taking things out; what we leave behind still has to work."

Dissection assisted by an energy device is a more recent development in their hands. "We have now utilized energy in well over 100 patients undergoing both segmentectomy and lobectomy," he said.

Another essential goal of segmentectomy is to achieve a margin-to-tumor ratio greater than the size of the tumor itself, he said. As an example, he cited the case of a 71-year-old man with a history of diverticulitis with a pulmonary nodule picked up on an abdominal CT scan. The nodule was 1.7 cm, well confined in the outer third of the lung, and well centered within the basilar segment. Fine-needle aspiration of the nodule revealed adenocarcinoma. "He was considered to be an excellent candidate for segmentectomy. In this case, the margin was about 5 cm for a 1.7-cm tumor."

He and his colleagues published additional details of the segmentectomies they performed between 2002 and 2010 at UPMC in a retrospective study (Ann. Thorac. Surg. 2012:93:1780-7).

He said that he had no disclosures.

SAN FRANCISCO – Thoracic surgeons should not shy away from segmentectomy in select patients with NSCLC, an expert advises, because the technique confers specific advantages.

In addition, it is as feasible as lobectomy. "If you can do a lobectomy, you can do a segmentectomy. There is no doubt about it," Dr. Matthew J. Schuchert said at the annual meeting of the American Association for Thoracic Surgery.

He shared patient selection criteria and technique tips based on experience with the more than 800 segmentectomies performed at the University of Pittsburgh Medical Center/UPMC Cancer Institute, where he is a general and thoracic surgeon.

Anatomic segmentectomy accomplishes the fundamental surgical tenets achieved by lobectomy, including R0 resection, adequate margins, and an opportunity for systematic nodal staging in early lung cancer, Dr. Schuchert said.

Lung preservation is another potential benefit of segmentectomy and the procedure is particularly useful for tumors with low malignancy potential where you may not have to take out an entire lobe to gain oncologic control, he said.

Equivalent survival to lobectomy has been demonstrated for stage 1A disease, especially for lesions smaller than 2 cm. In addition, "there may be decreased morbidity and mortality risk, especially among the elderly, a population we are going to be seeing more and more of."

Patient selection is paramount. In addition to the elderly, segmentectomy is particularly suitable for patients with marginal pulmonary function; those with "ground glass opacity" that may have low nodal positivity rates; and those who had prior lobectomy seeking parenchymal preservation.

"If you are contemplating the use of segmentectomy, it all really comes down to evaluation of the case," he said. Preoperative imaging ideally reveals a small tumor (less than 2 cm) in the outer one third of the lung. In addition, tumors should be confined to a discrete segmental boundary. "That’s critical. That’s the ticket for success," he said.

Surgeons can use the same anatomic approach they employ for lobectomy, only direct it at one segment. It is important to know segmental vascular and segmental bronchial anatomy, Dr. Schuchert noted.

"All of the same anatomic concerns, exposure concerns, and dissection concerns and techniques really apply." Segmentectomy can be performed through video-assisted thoracic surgery (VATS) or an open approach; the majority of cases at the University of Pittsburgh are VATS.

"We typically position the camera at about the seventh interspace in the mid-axillary line. Along the same interspace, a little more posteriorly, we will utilize a 10-mm incision for retraction and stapling. The access incision is pretty much the same as it is for a VATS lobectomy, usually somewhere along the line of the inframammary crease, and we place it right over the anterior hilum." This incision is usually around the level of the minor fissure on the right and slightly above the major fissure on the left, he added. Next, a 5-mm incision is made for retraction; it can also be particularly useful during node dissection, Dr. Schuchert said.

Preservation of the remaining lung is always a goal. "If you devitalize the remaining lung or impinge upon the bronchial supply, that patient is going to be doomed to have some perioperative issues." Remember that segmentectomy is a functional operation as well, he pointed out. "We are not just taking things out; what we leave behind still has to work."

Dissection assisted by an energy device is a more recent development in their hands. "We have now utilized energy in well over 100 patients undergoing both segmentectomy and lobectomy," he said.

Another essential goal of segmentectomy is to achieve a margin-to-tumor ratio greater than the size of the tumor itself, he said. As an example, he cited the case of a 71-year-old man with a history of diverticulitis with a pulmonary nodule picked up on an abdominal CT scan. The nodule was 1.7 cm, well confined in the outer third of the lung, and well centered within the basilar segment. Fine-needle aspiration of the nodule revealed adenocarcinoma. "He was considered to be an excellent candidate for segmentectomy. In this case, the margin was about 5 cm for a 1.7-cm tumor."

He and his colleagues published additional details of the segmentectomies they performed between 2002 and 2010 at UPMC in a retrospective study (Ann. Thorac. Surg. 2012:93:1780-7).

He said that he had no disclosures.

The Food and Drug Administration has declined to approve the oral anticoagulant rivaroxaban as a treatment for patients with acute coronary syndrome, according to a statement issued by Johnson & Johnson.

The agency has issued a complete response letter regarding the supplemental indication for rivaroxaban for use in reducing the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS) that has been under review at the agency, the statement said.

The FDA issues complete response letters for a drug when there are outstanding issues that need to be resolved before approval; the FDA does not make these letters public, and the company statement did not provide any details about the issues that were raised in the FDA letter.

Rivaroxaban, an oral factor Xa inhibitor marketed as Xarelto by Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, was initially approved in July 2011 for the prophylaxis of deep vein thrombosis in patients undergoing knee or hip replacement surgery; and in November 2011 for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

In December of last year, Janssen submitted the ACS application for rivaroxaban at a dose of 2.5 mg twice a day, to "reduce the risk of thrombotic cardiovascular events in patients with ACS [ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI), or unstable angina (UA)] in combination with aspirin alone or with aspirin plus clopidogrel or ticlopidine."

But at a meeting in May, the majority of the FDA’s Cardiovascular and Renal Drugs Advisory Committee recommended against approval for this indication, with those voting no citing a large amount of missing data in ATLAS ACS, the pivotal study, as well as safety concerns, among the reasons for their votes (6 to 4 with one abstention).

In the study of 15,526 people with recent ACS, the risk of the combined end point of a composite of cardiovascular death, MI, or stroke, the primary efficacy end point, was reduced by 15% among those on the 2.5-mg twice-daily dosage who were also on aspirin plus a thienopyridine over those on placebo plus dual therapy (primarily driven by a reduction in CV deaths).

This was a statistically significant difference but with a marginal P value of .039. Among those on 2.5 mg twice a day, major bleeding was significantly higher (1.3%) than in those on placebo (0.4%). Intracranial hemorrhage and hemorrhagic stroke rates were also higher in those on rivaroxaban than in those on placebo (N. Engl. J. Med. 2012;366:9-19).

In an interview, Dr. Sanjay Kaul, one of the panel members who voted against approval, referred to the degree of missing data and the lack of robust data in favor of rivaroxaban in this study, pointing out that fewer than 10 excess events in the treatment arm would have negated the statistically significant treatment advantage.

He also referred to the lack of a dose response (there was a greater benefit with the lower dose), a differential impact of the two doses on cardiovascular mortality and MI that was difficult to explain, and the lack of external evidence supporting an incremental advantage of anticoagulant therapy over antiplatelet therapy.

Although the contents of the FDA’s letter are not made public, "I suspect some, if not all, of these issues likely contributed to the unfavorable verdict," said Dr. Kaul, who is the director of the vascular physiology and thrombosis research laboratory at the Burns and Allen Research Institute, Cedars-Sinai Medical Center, Los Angeles.

"I hope that with proper due diligence, which might involve additional trials, the sponsor will be able to respond satisfactorily to the FDA’s concerns," he added.

In the Johnson & Johnson statement, Dr. Paul Burton, vice president and cardiovascular franchise medical leader at Janssen R&D, said that the company "will continue to work with the FDA to fully address their questions as quickly as possible."

Warfarin and three P2Y12 inhibitors – ticagrelor (Brilinta), prasugrel (Effient), and ticlopidine (Ticlid) – are approved for reducing the risk of thrombotic CV events in patients with ACS.

Dr. Kaul holds stock in Johnson & Johnson, but less than the amount for which a waiver to be on an FDA panel is required.

The Food and Drug Administration has declined to approve the oral anticoagulant rivaroxaban as a treatment for patients with acute coronary syndrome, according to a statement issued by Johnson & Johnson.

The agency has issued a complete response letter regarding the supplemental indication for rivaroxaban for use in reducing the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS) that has been under review at the agency, the statement said.

The FDA issues complete response letters for a drug when there are outstanding issues that need to be resolved before approval; the FDA does not make these letters public, and the company statement did not provide any details about the issues that were raised in the FDA letter.

Rivaroxaban, an oral factor Xa inhibitor marketed as Xarelto by Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, was initially approved in July 2011 for the prophylaxis of deep vein thrombosis in patients undergoing knee or hip replacement surgery; and in November 2011 for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

In December of last year, Janssen submitted the ACS application for rivaroxaban at a dose of 2.5 mg twice a day, to "reduce the risk of thrombotic cardiovascular events in patients with ACS [ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI), or unstable angina (UA)] in combination with aspirin alone or with aspirin plus clopidogrel or ticlopidine."

But at a meeting in May, the majority of the FDA’s Cardiovascular and Renal Drugs Advisory Committee recommended against approval for this indication, with those voting no citing a large amount of missing data in ATLAS ACS, the pivotal study, as well as safety concerns, among the reasons for their votes (6 to 4 with one abstention).

In the study of 15,526 people with recent ACS, the risk of the combined end point of a composite of cardiovascular death, MI, or stroke, the primary efficacy end point, was reduced by 15% among those on the 2.5-mg twice-daily dosage who were also on aspirin plus a thienopyridine over those on placebo plus dual therapy (primarily driven by a reduction in CV deaths).

This was a statistically significant difference but with a marginal P value of .039. Among those on 2.5 mg twice a day, major bleeding was significantly higher (1.3%) than in those on placebo (0.4%). Intracranial hemorrhage and hemorrhagic stroke rates were also higher in those on rivaroxaban than in those on placebo (N. Engl. J. Med. 2012;366:9-19).

In an interview, Dr. Sanjay Kaul, one of the panel members who voted against approval, referred to the degree of missing data and the lack of robust data in favor of rivaroxaban in this study, pointing out that fewer than 10 excess events in the treatment arm would have negated the statistically significant treatment advantage.

He also referred to the lack of a dose response (there was a greater benefit with the lower dose), a differential impact of the two doses on cardiovascular mortality and MI that was difficult to explain, and the lack of external evidence supporting an incremental advantage of anticoagulant therapy over antiplatelet therapy.

Although the contents of the FDA’s letter are not made public, "I suspect some, if not all, of these issues likely contributed to the unfavorable verdict," said Dr. Kaul, who is the director of the vascular physiology and thrombosis research laboratory at the Burns and Allen Research Institute, Cedars-Sinai Medical Center, Los Angeles.

"I hope that with proper due diligence, which might involve additional trials, the sponsor will be able to respond satisfactorily to the FDA’s concerns," he added.

In the Johnson & Johnson statement, Dr. Paul Burton, vice president and cardiovascular franchise medical leader at Janssen R&D, said that the company "will continue to work with the FDA to fully address their questions as quickly as possible."

Warfarin and three P2Y12 inhibitors – ticagrelor (Brilinta), prasugrel (Effient), and ticlopidine (Ticlid) – are approved for reducing the risk of thrombotic CV events in patients with ACS.

Dr. Kaul holds stock in Johnson & Johnson, but less than the amount for which a waiver to be on an FDA panel is required.

The Food and Drug Administration has declined to approve the oral anticoagulant rivaroxaban as a treatment for patients with acute coronary syndrome, according to a statement issued by Johnson & Johnson.

The agency has issued a complete response letter regarding the supplemental indication for rivaroxaban for use in reducing the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS) that has been under review at the agency, the statement said.

The FDA issues complete response letters for a drug when there are outstanding issues that need to be resolved before approval; the FDA does not make these letters public, and the company statement did not provide any details about the issues that were raised in the FDA letter.

Rivaroxaban, an oral factor Xa inhibitor marketed as Xarelto by Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, was initially approved in July 2011 for the prophylaxis of deep vein thrombosis in patients undergoing knee or hip replacement surgery; and in November 2011 for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

In December of last year, Janssen submitted the ACS application for rivaroxaban at a dose of 2.5 mg twice a day, to "reduce the risk of thrombotic cardiovascular events in patients with ACS [ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI), or unstable angina (UA)] in combination with aspirin alone or with aspirin plus clopidogrel or ticlopidine."

But at a meeting in May, the majority of the FDA’s Cardiovascular and Renal Drugs Advisory Committee recommended against approval for this indication, with those voting no citing a large amount of missing data in ATLAS ACS, the pivotal study, as well as safety concerns, among the reasons for their votes (6 to 4 with one abstention).

In the study of 15,526 people with recent ACS, the risk of the combined end point of a composite of cardiovascular death, MI, or stroke, the primary efficacy end point, was reduced by 15% among those on the 2.5-mg twice-daily dosage who were also on aspirin plus a thienopyridine over those on placebo plus dual therapy (primarily driven by a reduction in CV deaths).

This was a statistically significant difference but with a marginal P value of .039. Among those on 2.5 mg twice a day, major bleeding was significantly higher (1.3%) than in those on placebo (0.4%). Intracranial hemorrhage and hemorrhagic stroke rates were also higher in those on rivaroxaban than in those on placebo (N. Engl. J. Med. 2012;366:9-19).

In an interview, Dr. Sanjay Kaul, one of the panel members who voted against approval, referred to the degree of missing data and the lack of robust data in favor of rivaroxaban in this study, pointing out that fewer than 10 excess events in the treatment arm would have negated the statistically significant treatment advantage.

He also referred to the lack of a dose response (there was a greater benefit with the lower dose), a differential impact of the two doses on cardiovascular mortality and MI that was difficult to explain, and the lack of external evidence supporting an incremental advantage of anticoagulant therapy over antiplatelet therapy.

Although the contents of the FDA’s letter are not made public, "I suspect some, if not all, of these issues likely contributed to the unfavorable verdict," said Dr. Kaul, who is the director of the vascular physiology and thrombosis research laboratory at the Burns and Allen Research Institute, Cedars-Sinai Medical Center, Los Angeles.

"I hope that with proper due diligence, which might involve additional trials, the sponsor will be able to respond satisfactorily to the FDA’s concerns," he added.

In the Johnson & Johnson statement, Dr. Paul Burton, vice president and cardiovascular franchise medical leader at Janssen R&D, said that the company "will continue to work with the FDA to fully address their questions as quickly as possible."

Warfarin and three P2Y12 inhibitors – ticagrelor (Brilinta), prasugrel (Effient), and ticlopidine (Ticlid) – are approved for reducing the risk of thrombotic CV events in patients with ACS.

Dr. Kaul holds stock in Johnson & Johnson, but less than the amount for which a waiver to be on an FDA panel is required.

Doctors providing primary care services could earn some additional money next year under a new Medicare proposal that would pay them for coordinating the care of their patients who have been discharged from a hospital or nursing home.

Medicare proposes to create a new G code that would allow physicians to bill for postdischarge transitional care services such as obtaining and reviewing the patient’s discharge summary; reviewing diagnostic tests and treatments; updating the medical record within 14 business days post discharge; establishing a new care plan; educating the patient or caregiver within 2 business days post discharge; and communicating with other health care providers.

The G code would apply when a Medicare beneficiary is discharged from an inpatient stay, a skilled nursing facility, an outpatient hospital observation unit, partial hospitalization services, or a community mental health center.

Officials at the Centers for Medicare and Medicaid Services (CMS) estimate that the use of the new G code could increase payments to family physicians by 7%; other doctors who provide primary care services could see a bump of 3%-5% starting in January 2013.

"Helping primary care doctors will help improve patient care and lower health care costs long term," CMS Acting Administrator Marilyn B. Tavenner said in a statement.

The news that CMS will pay physicians specifically for providing these non face-to-face postdischarge services is "very encouraging," said Shari Erickson, director of regulatory and insurer affairs at the American College of Physicians. CMS is projecting that most internists will see about a 5% increase in Medicare payments due to the policy change. Ms. Erickson said the amount will vary based on how often different types of physicians bill for the codes.

The rule does not specify which physicians can use the new G code but Medicare will only pay one physician to perform the service. Ms. Erickson said most of the time it will likely be a primary care physician.

The ACP is now waiting to see how the CMS proposal aligns with work already underway by the American Medical Association’s CPT Editorial Panel and its Specialty Society Relative Value Scale Update Committee (RUC) to develop codes for these services.

The addition of the new G code is a "good step," said Dr. Glen Stream, president of the American Academy of Family Physicians. The AAFP has been working on this issue for a while and earlier this year issued recommendations on better ways to pay for primary care services. Dr. Stream said they would next like to see CMS develop evaluation and management codes that are specific to primary care, rather than simply increase payments for the 99213 and 99214 codes that are used by many specialties.

The postdischarge transitional care services plan was part of the 2013 Medicare Physician Fee Schedule proposed rule, which was released July 6.

But the fee schedule proposal is not all good news. The proposed rule also details the 27% across-the-board cut to physician fees scheduled to take effect on Jan. 1. The reduction is required by law, based in part on spending targets set under the Sustainable Growth Rate (SGR) formula, which links fees to changes in the gross domestic product.

That formula has been criticized by physicians and lawmakers for years. While no long-term solution to the SGR problem has ever been formulated, lawmakers have taken short-term measures to keep the physician fee cuts from going into effect over the last several years.

The proposed rule would also mean cuts to payments for many cardiology diagnostic tests. Under the proposal, CMS is seeking to expand its multiple-procedure payment reduction policy to diagnostic tests in both cardiology and ophthalmology.

Starting in January 2013, there would be an across-the-board reduction of 25% to the technical component for second and subsequent procedures performed by the same physician or physicians in the same group practice for the same patient on the same day. The cut will not apply to the professional component of the fee. The proposed rule lists 131 diagnostic cardiovascular services that would be subject to the multiple-procedure payment reduction policy.

Dr. William Zoghbi, president of the American College of Cardiology, said the planned reductions in cardiology diagnostic test fees would be bad for both physicians and patients. "This policy disadvantages physicians who aim for efficiency, and reduces payments based on a misguided understanding of how different services, such as echocardiology and SPECT imaging, are from one another," Dr. Zoghbi said in a statement. "Furthermore, it would lead to a major inconvenience to patients."

The 2013 fee schedule proposal also outlines the implementation of the physician value-based payment modifier, which adjusts physician payments based on the quality and cost of the care they provide. The program, which was mandated under the Affordable Care Act, will be phased in over 3 years starting in 2015.

The proposed rule also would implement the physician value-based payment modifier for all medical groups with 25 or more eligible providers starting in 2015.

Groups that do not participate in the Physician Quality Reporting System would see a 1% cut in Medicare payments. Groups that do participate would be paid in part based on their performance.

Groups with higher quality and lower costs would be paid more, and those with lower quality and higher costs would be paid less, according to CMS. The payment adjustments made in 2015 will be based on 2013 performance in the PQRS.

CMS will publish the proposed rule in the Federal Register on July 30, and will accept public comments until Sept. 4. The agency plans to finalize the physician payment rule by Nov. 1.

Doctors providing primary care services could earn some additional money next year under a new Medicare proposal that would pay them for coordinating the care of their patients who have been discharged from a hospital or nursing home.

Medicare proposes to create a new G code that would allow physicians to bill for postdischarge transitional care services such as obtaining and reviewing the patient’s discharge summary; reviewing diagnostic tests and treatments; updating the medical record within 14 business days post discharge; establishing a new care plan; educating the patient or caregiver within 2 business days post discharge; and communicating with other health care providers.

The G code would apply when a Medicare beneficiary is discharged from an inpatient stay, a skilled nursing facility, an outpatient hospital observation unit, partial hospitalization services, or a community mental health center.

Officials at the Centers for Medicare and Medicaid Services (CMS) estimate that the use of the new G code could increase payments to family physicians by 7%; other doctors who provide primary care services could see a bump of 3%-5% starting in January 2013.

"Helping primary care doctors will help improve patient care and lower health care costs long term," CMS Acting Administrator Marilyn B. Tavenner said in a statement.

The news that CMS will pay physicians specifically for providing these non face-to-face postdischarge services is "very encouraging," said Shari Erickson, director of regulatory and insurer affairs at the American College of Physicians. CMS is projecting that most internists will see about a 5% increase in Medicare payments due to the policy change. Ms. Erickson said the amount will vary based on how often different types of physicians bill for the codes.

The rule does not specify which physicians can use the new G code but Medicare will only pay one physician to perform the service. Ms. Erickson said most of the time it will likely be a primary care physician.

The ACP is now waiting to see how the CMS proposal aligns with work already underway by the American Medical Association’s CPT Editorial Panel and its Specialty Society Relative Value Scale Update Committee (RUC) to develop codes for these services.

The addition of the new G code is a "good step," said Dr. Glen Stream, president of the American Academy of Family Physicians. The AAFP has been working on this issue for a while and earlier this year issued recommendations on better ways to pay for primary care services. Dr. Stream said they would next like to see CMS develop evaluation and management codes that are specific to primary care, rather than simply increase payments for the 99213 and 99214 codes that are used by many specialties.

The postdischarge transitional care services plan was part of the 2013 Medicare Physician Fee Schedule proposed rule, which was released July 6.

But the fee schedule proposal is not all good news. The proposed rule also details the 27% across-the-board cut to physician fees scheduled to take effect on Jan. 1. The reduction is required by law, based in part on spending targets set under the Sustainable Growth Rate (SGR) formula, which links fees to changes in the gross domestic product.

That formula has been criticized by physicians and lawmakers for years. While no long-term solution to the SGR problem has ever been formulated, lawmakers have taken short-term measures to keep the physician fee cuts from going into effect over the last several years.

The proposed rule would also mean cuts to payments for many cardiology diagnostic tests. Under the proposal, CMS is seeking to expand its multiple-procedure payment reduction policy to diagnostic tests in both cardiology and ophthalmology.

Starting in January 2013, there would be an across-the-board reduction of 25% to the technical component for second and subsequent procedures performed by the same physician or physicians in the same group practice for the same patient on the same day. The cut will not apply to the professional component of the fee. The proposed rule lists 131 diagnostic cardiovascular services that would be subject to the multiple-procedure payment reduction policy.

Dr. William Zoghbi, president of the American College of Cardiology, said the planned reductions in cardiology diagnostic test fees would be bad for both physicians and patients. "This policy disadvantages physicians who aim for efficiency, and reduces payments based on a misguided understanding of how different services, such as echocardiology and SPECT imaging, are from one another," Dr. Zoghbi said in a statement. "Furthermore, it would lead to a major inconvenience to patients."

The 2013 fee schedule proposal also outlines the implementation of the physician value-based payment modifier, which adjusts physician payments based on the quality and cost of the care they provide. The program, which was mandated under the Affordable Care Act, will be phased in over 3 years starting in 2015.

The proposed rule also would implement the physician value-based payment modifier for all medical groups with 25 or more eligible providers starting in 2015.

Groups that do not participate in the Physician Quality Reporting System would see a 1% cut in Medicare payments. Groups that do participate would be paid in part based on their performance.

Groups with higher quality and lower costs would be paid more, and those with lower quality and higher costs would be paid less, according to CMS. The payment adjustments made in 2015 will be based on 2013 performance in the PQRS.

CMS will publish the proposed rule in the Federal Register on July 30, and will accept public comments until Sept. 4. The agency plans to finalize the physician payment rule by Nov. 1.

Doctors providing primary care services could earn some additional money next year under a new Medicare proposal that would pay them for coordinating the care of their patients who have been discharged from a hospital or nursing home.

Medicare proposes to create a new G code that would allow physicians to bill for postdischarge transitional care services such as obtaining and reviewing the patient’s discharge summary; reviewing diagnostic tests and treatments; updating the medical record within 14 business days post discharge; establishing a new care plan; educating the patient or caregiver within 2 business days post discharge; and communicating with other health care providers.

The G code would apply when a Medicare beneficiary is discharged from an inpatient stay, a skilled nursing facility, an outpatient hospital observation unit, partial hospitalization services, or a community mental health center.

Officials at the Centers for Medicare and Medicaid Services (CMS) estimate that the use of the new G code could increase payments to family physicians by 7%; other doctors who provide primary care services could see a bump of 3%-5% starting in January 2013.

"Helping primary care doctors will help improve patient care and lower health care costs long term," CMS Acting Administrator Marilyn B. Tavenner said in a statement.

The news that CMS will pay physicians specifically for providing these non face-to-face postdischarge services is "very encouraging," said Shari Erickson, director of regulatory and insurer affairs at the American College of Physicians. CMS is projecting that most internists will see about a 5% increase in Medicare payments due to the policy change. Ms. Erickson said the amount will vary based on how often different types of physicians bill for the codes.

The rule does not specify which physicians can use the new G code but Medicare will only pay one physician to perform the service. Ms. Erickson said most of the time it will likely be a primary care physician.

The ACP is now waiting to see how the CMS proposal aligns with work already underway by the American Medical Association’s CPT Editorial Panel and its Specialty Society Relative Value Scale Update Committee (RUC) to develop codes for these services.

The addition of the new G code is a "good step," said Dr. Glen Stream, president of the American Academy of Family Physicians. The AAFP has been working on this issue for a while and earlier this year issued recommendations on better ways to pay for primary care services. Dr. Stream said they would next like to see CMS develop evaluation and management codes that are specific to primary care, rather than simply increase payments for the 99213 and 99214 codes that are used by many specialties.

The postdischarge transitional care services plan was part of the 2013 Medicare Physician Fee Schedule proposed rule, which was released July 6.

But the fee schedule proposal is not all good news. The proposed rule also details the 27% across-the-board cut to physician fees scheduled to take effect on Jan. 1. The reduction is required by law, based in part on spending targets set under the Sustainable Growth Rate (SGR) formula, which links fees to changes in the gross domestic product.

That formula has been criticized by physicians and lawmakers for years. While no long-term solution to the SGR problem has ever been formulated, lawmakers have taken short-term measures to keep the physician fee cuts from going into effect over the last several years.

The proposed rule would also mean cuts to payments for many cardiology diagnostic tests. Under the proposal, CMS is seeking to expand its multiple-procedure payment reduction policy to diagnostic tests in both cardiology and ophthalmology.

Starting in January 2013, there would be an across-the-board reduction of 25% to the technical component for second and subsequent procedures performed by the same physician or physicians in the same group practice for the same patient on the same day. The cut will not apply to the professional component of the fee. The proposed rule lists 131 diagnostic cardiovascular services that would be subject to the multiple-procedure payment reduction policy.

Dr. William Zoghbi, president of the American College of Cardiology, said the planned reductions in cardiology diagnostic test fees would be bad for both physicians and patients. "This policy disadvantages physicians who aim for efficiency, and reduces payments based on a misguided understanding of how different services, such as echocardiology and SPECT imaging, are from one another," Dr. Zoghbi said in a statement. "Furthermore, it would lead to a major inconvenience to patients."

The 2013 fee schedule proposal also outlines the implementation of the physician value-based payment modifier, which adjusts physician payments based on the quality and cost of the care they provide. The program, which was mandated under the Affordable Care Act, will be phased in over 3 years starting in 2015.

The proposed rule also would implement the physician value-based payment modifier for all medical groups with 25 or more eligible providers starting in 2015.

Groups that do not participate in the Physician Quality Reporting System would see a 1% cut in Medicare payments. Groups that do participate would be paid in part based on their performance.

Groups with higher quality and lower costs would be paid more, and those with lower quality and higher costs would be paid less, according to CMS. The payment adjustments made in 2015 will be based on 2013 performance in the PQRS.

CMS will publish the proposed rule in the Federal Register on July 30, and will accept public comments until Sept. 4. The agency plans to finalize the physician payment rule by Nov. 1.

The Supreme Court's decision to largely uphold the Affordable Care Act in essence preserved the status quo for the health system and took away some uncertainty - but only in the short term. The congressional and presidential elections in November could bring further changes to the law.

For now, though, the nation's physicians are pondering the court's ruling and how it will affect their practices. Concerns remain regarding some aspects of the law, and there is uncertainty on what the justices' Medicaid decision means.

Christian Shalgian, director of the division of advocacy and health policy at the American College of Surgeons, said he was surprised by the ruling, adding that surgeons are more concerned about what the law doesn't do than what it does.

"The biggest issue in my mind [with] the Affordable Care Act is what's not included in the [law]," said Mr. Shalgian. "The Medicare physician payment issue is one that's driving health care costs, and it needs to be fixed."

However, many other physician groups praised the court's opinions, noting that keeping the law in place would increase health care coverage and maintain the ACA's enhanced preventive care benefits.

"We are pleased that this decision means millions of Americans can look forward to the coverage they need to get healthy and stay healthy," said Dr. Jeremy Lazarus, president of the American Medical Association, in a statement. "This decision protects important improvements, such as ending coverage denials due to preexisting conditions and lifetime caps on insurance and allowing the 2.5 million young adults up to age 26 who gained coverage under the law to stay on their parents' health insurance policies."

Dr. David L. Bronson, president of the American College of Physicians, noted in a statement that although the group did not take a position on the constitutional issues, "we believe that the individual insurance mandate, combined with the ACA's subsidies to buy qualified coverage through state marketplaces (exchanges), Medicaid expansion to more low-income persons, and consumer protections against insurance practices that deny or limit coverage, are the most effective ways to expand coverage to nearly all Americans."

The American Academy of Family Physicians said that keeping the law in place will also allow the continuation of efforts to boost the breadth and depth of primary care.

"The Supreme Court decision maintains already-launched initiatives that support wider implementation of the patient-centered medical home and that value primary medical care through payment incentives for primary care physicians," said Dr. Glen Stream, AAFP president, in a statement.

Oncologists noted that they were pleased that many provisions that protect cancer patients would continue to stay intact, such as coverage for preventive screenings like colonoscopies and mammograms, the elimination of lifetime caps and preexisting condition exclusions for insurance plans, and the requirement that private insurers cover the cost of participating in clinical trials.

Cardiologists also applauded the fact that provisions ensuring preventive care and coverage of preexisting conditions would stay in place. American College of Cardiology president William Zoghbi said in a statement that the organization "favors provisions in the law that support preventive care, access to care, elimination of waste, and a payment system that encourages quality." However, the transformation is not complete. "Hard work remains ahead before we arrive at a sustainable payment system that emphasizes value and a strong patient-doctor relationship," said Dr. Zoghbi.

Because the law basically remains the same - for now - the 2.3% excise tax on medical devices will still go into effect on Jan. 1, 2013. AdvaMed, an industry lobbying group, said that it will continue to try to overturn that tax, which could end up driving up the cost of devices such as pacemakers.

The largely positive statements from organized medicine did not hide the fact that many individual physicians are still fearful of the law's effect on their practice.

In a survey of 644 primary care physicians that was conducted the day the Supreme Court ruled, 66% of respondents said that they did not believe the law could achieve health care coverage for all Americans. The poll was conducted by MDLinx, a Web-based information provider for doctors. "The survey showed a surprisingly high level of skepticism among primary care physicians," said Stephen Smith, chief marketing officer for MDLinx, in a statement. The poll also found that only 21% said that increased patient volume would have an "extremely positive" impact on their medical practice. Almost half said it would have an "extremely negative" impact. Respondents expressed concerns about the shortage of primary care doctors.

And most physician organizations indicated their continuing dissatisfaction with some parts of the law, including the Independent Payment Advisory Board, or IPAB, and the lack of any concrete malpractice reform.

The American Association of Clinical Urologists (AACU), the American Urological Association (AUA), and the Large Urology Group Practice Association (LUGPA) issued a joint statement, noting that "we are concerned that there are key aspects to this law that will, ultimately, hurt this nation's ability to provide widespread care for its citizens," including the IPAB. Mr. Shalgian said that the IPAB has been an issue for the ACS since it was first proposed.

At a press briefing called by the Republican Doctors Caucus, Rep. Phil Gingrey (R-Ga.), an ob.gyn., said that he and his fellow caucus members would work to overturn most if not all of the ACA, starting with the IPAB.

Some of Rep. Gingrey's colleagues were adamant that they'd do everything possible to overturn the law. Rep. Tom Price (R-Ga.), an orthopedic surgeon, said that the ACA "violates accessibility, violates affordability, violates quality, violates choices."

Rep. Paul Broun (R-Ga.) called the Act a "destroyer." He said it would "destroy a patient's ability to go to see a doctor and get the quality care they desperately need." Added Dr. Broun, "Obamacare must be repealed. It must be replaced with some policy that will make health care cheaper for everyone, provide coverage for all Americans, and save Medicare from going broke."

With the Supreme Court's efforts in the rear-view mirror, Republicans renewed their vow to repeal all or part of the ACA; however, that's unlikely to happen as long as Democrats maintain control of the Senate and the White House.

If Republicans win a majority in the Senate in November, and if Mitt Romney wins the presidential election, there could be major change.

In the meantime, most physician groups said they would work to fix the parts of the law that were objectionable.

Mr. Shalgian said that the ACS will be exploring options for medical liability reform during the annual Clinical Congress in Chicago.

Dr. Stream of the AAFP said that such reform is essential. "The [ACA] provides a foundation for reforming our health care system, but much work still lies ahead including a permanent replacement for the Sustainable Growth Rate formula and meaningful medical liability reform," he said.

Dr. Bronson of the ACP said that the organization realizes that "even with the Supreme Court's ruling, the political debate over the ACA continues and that its future is a major issue in the 2012 election."

He added, "We hope that a day will come when the debate will no longer be polarized between repeal on one hand, or keeping the law exactly as it is on the other, but on preserving all of the good things that it does while making needed improvements," among which would be "meaningful reforms to the medical liability system."

The Supreme Court's decision to largely uphold the Affordable Care Act in essence preserved the status quo for the health system and took away some uncertainty - but only in the short term. The congressional and presidential elections in November could bring further changes to the law.

For now, though, the nation's physicians are pondering the court's ruling and how it will affect their practices. Concerns remain regarding some aspects of the law, and there is uncertainty on what the justices' Medicaid decision means.

Christian Shalgian, director of the division of advocacy and health policy at the American College of Surgeons, said he was surprised by the ruling, adding that surgeons are more concerned about what the law doesn't do than what it does.

"The biggest issue in my mind [with] the Affordable Care Act is what's not included in the [law]," said Mr. Shalgian. "The Medicare physician payment issue is one that's driving health care costs, and it needs to be fixed."

However, many other physician groups praised the court's opinions, noting that keeping the law in place would increase health care coverage and maintain the ACA's enhanced preventive care benefits.

"We are pleased that this decision means millions of Americans can look forward to the coverage they need to get healthy and stay healthy," said Dr. Jeremy Lazarus, president of the American Medical Association, in a statement. "This decision protects important improvements, such as ending coverage denials due to preexisting conditions and lifetime caps on insurance and allowing the 2.5 million young adults up to age 26 who gained coverage under the law to stay on their parents' health insurance policies."

Dr. David L. Bronson, president of the American College of Physicians, noted in a statement that although the group did not take a position on the constitutional issues, "we believe that the individual insurance mandate, combined with the ACA's subsidies to buy qualified coverage through state marketplaces (exchanges), Medicaid expansion to more low-income persons, and consumer protections against insurance practices that deny or limit coverage, are the most effective ways to expand coverage to nearly all Americans."

The American Academy of Family Physicians said that keeping the law in place will also allow the continuation of efforts to boost the breadth and depth of primary care.

"The Supreme Court decision maintains already-launched initiatives that support wider implementation of the patient-centered medical home and that value primary medical care through payment incentives for primary care physicians," said Dr. Glen Stream, AAFP president, in a statement.

Oncologists noted that they were pleased that many provisions that protect cancer patients would continue to stay intact, such as coverage for preventive screenings like colonoscopies and mammograms, the elimination of lifetime caps and preexisting condition exclusions for insurance plans, and the requirement that private insurers cover the cost of participating in clinical trials.

Cardiologists also applauded the fact that provisions ensuring preventive care and coverage of preexisting conditions would stay in place. American College of Cardiology president William Zoghbi said in a statement that the organization "favors provisions in the law that support preventive care, access to care, elimination of waste, and a payment system that encourages quality." However, the transformation is not complete. "Hard work remains ahead before we arrive at a sustainable payment system that emphasizes value and a strong patient-doctor relationship," said Dr. Zoghbi.

Because the law basically remains the same - for now - the 2.3% excise tax on medical devices will still go into effect on Jan. 1, 2013. AdvaMed, an industry lobbying group, said that it will continue to try to overturn that tax, which could end up driving up the cost of devices such as pacemakers.

The largely positive statements from organized medicine did not hide the fact that many individual physicians are still fearful of the law's effect on their practice.

In a survey of 644 primary care physicians that was conducted the day the Supreme Court ruled, 66% of respondents said that they did not believe the law could achieve health care coverage for all Americans. The poll was conducted by MDLinx, a Web-based information provider for doctors. "The survey showed a surprisingly high level of skepticism among primary care physicians," said Stephen Smith, chief marketing officer for MDLinx, in a statement. The poll also found that only 21% said that increased patient volume would have an "extremely positive" impact on their medical practice. Almost half said it would have an "extremely negative" impact. Respondents expressed concerns about the shortage of primary care doctors.

And most physician organizations indicated their continuing dissatisfaction with some parts of the law, including the Independent Payment Advisory Board, or IPAB, and the lack of any concrete malpractice reform.

The American Association of Clinical Urologists (AACU), the American Urological Association (AUA), and the Large Urology Group Practice Association (LUGPA) issued a joint statement, noting that "we are concerned that there are key aspects to this law that will, ultimately, hurt this nation's ability to provide widespread care for its citizens," including the IPAB. Mr. Shalgian said that the IPAB has been an issue for the ACS since it was first proposed.

At a press briefing called by the Republican Doctors Caucus, Rep. Phil Gingrey (R-Ga.), an ob.gyn., said that he and his fellow caucus members would work to overturn most if not all of the ACA, starting with the IPAB.

Some of Rep. Gingrey's colleagues were adamant that they'd do everything possible to overturn the law. Rep. Tom Price (R-Ga.), an orthopedic surgeon, said that the ACA "violates accessibility, violates affordability, violates quality, violates choices."

Rep. Paul Broun (R-Ga.) called the Act a "destroyer." He said it would "destroy a patient's ability to go to see a doctor and get the quality care they desperately need." Added Dr. Broun, "Obamacare must be repealed. It must be replaced with some policy that will make health care cheaper for everyone, provide coverage for all Americans, and save Medicare from going broke."

With the Supreme Court's efforts in the rear-view mirror, Republicans renewed their vow to repeal all or part of the ACA; however, that's unlikely to happen as long as Democrats maintain control of the Senate and the White House.

If Republicans win a majority in the Senate in November, and if Mitt Romney wins the presidential election, there could be major change.

In the meantime, most physician groups said they would work to fix the parts of the law that were objectionable.

Mr. Shalgian said that the ACS will be exploring options for medical liability reform during the annual Clinical Congress in Chicago.

Dr. Stream of the AAFP said that such reform is essential. "The [ACA] provides a foundation for reforming our health care system, but much work still lies ahead including a permanent replacement for the Sustainable Growth Rate formula and meaningful medical liability reform," he said.

Dr. Bronson of the ACP said that the organization realizes that "even with the Supreme Court's ruling, the political debate over the ACA continues and that its future is a major issue in the 2012 election."

He added, "We hope that a day will come when the debate will no longer be polarized between repeal on one hand, or keeping the law exactly as it is on the other, but on preserving all of the good things that it does while making needed improvements," among which would be "meaningful reforms to the medical liability system."

The Supreme Court's decision to largely uphold the Affordable Care Act in essence preserved the status quo for the health system and took away some uncertainty - but only in the short term. The congressional and presidential elections in November could bring further changes to the law.

For now, though, the nation's physicians are pondering the court's ruling and how it will affect their practices. Concerns remain regarding some aspects of the law, and there is uncertainty on what the justices' Medicaid decision means.

Christian Shalgian, director of the division of advocacy and health policy at the American College of Surgeons, said he was surprised by the ruling, adding that surgeons are more concerned about what the law doesn't do than what it does.

"The biggest issue in my mind [with] the Affordable Care Act is what's not included in the [law]," said Mr. Shalgian. "The Medicare physician payment issue is one that's driving health care costs, and it needs to be fixed."

However, many other physician groups praised the court's opinions, noting that keeping the law in place would increase health care coverage and maintain the ACA's enhanced preventive care benefits.

"We are pleased that this decision means millions of Americans can look forward to the coverage they need to get healthy and stay healthy," said Dr. Jeremy Lazarus, president of the American Medical Association, in a statement. "This decision protects important improvements, such as ending coverage denials due to preexisting conditions and lifetime caps on insurance and allowing the 2.5 million young adults up to age 26 who gained coverage under the law to stay on their parents' health insurance policies."

Dr. David L. Bronson, president of the American College of Physicians, noted in a statement that although the group did not take a position on the constitutional issues, "we believe that the individual insurance mandate, combined with the ACA's subsidies to buy qualified coverage through state marketplaces (exchanges), Medicaid expansion to more low-income persons, and consumer protections against insurance practices that deny or limit coverage, are the most effective ways to expand coverage to nearly all Americans."

The American Academy of Family Physicians said that keeping the law in place will also allow the continuation of efforts to boost the breadth and depth of primary care.

"The Supreme Court decision maintains already-launched initiatives that support wider implementation of the patient-centered medical home and that value primary medical care through payment incentives for primary care physicians," said Dr. Glen Stream, AAFP president, in a statement.

Oncologists noted that they were pleased that many provisions that protect cancer patients would continue to stay intact, such as coverage for preventive screenings like colonoscopies and mammograms, the elimination of lifetime caps and preexisting condition exclusions for insurance plans, and the requirement that private insurers cover the cost of participating in clinical trials.

Cardiologists also applauded the fact that provisions ensuring preventive care and coverage of preexisting conditions would stay in place. American College of Cardiology president William Zoghbi said in a statement that the organization "favors provisions in the law that support preventive care, access to care, elimination of waste, and a payment system that encourages quality." However, the transformation is not complete. "Hard work remains ahead before we arrive at a sustainable payment system that emphasizes value and a strong patient-doctor relationship," said Dr. Zoghbi.

Because the law basically remains the same - for now - the 2.3% excise tax on medical devices will still go into effect on Jan. 1, 2013. AdvaMed, an industry lobbying group, said that it will continue to try to overturn that tax, which could end up driving up the cost of devices such as pacemakers.

The largely positive statements from organized medicine did not hide the fact that many individual physicians are still fearful of the law's effect on their practice.

In a survey of 644 primary care physicians that was conducted the day the Supreme Court ruled, 66% of respondents said that they did not believe the law could achieve health care coverage for all Americans. The poll was conducted by MDLinx, a Web-based information provider for doctors. "The survey showed a surprisingly high level of skepticism among primary care physicians," said Stephen Smith, chief marketing officer for MDLinx, in a statement. The poll also found that only 21% said that increased patient volume would have an "extremely positive" impact on their medical practice. Almost half said it would have an "extremely negative" impact. Respondents expressed concerns about the shortage of primary care doctors.

And most physician organizations indicated their continuing dissatisfaction with some parts of the law, including the Independent Payment Advisory Board, or IPAB, and the lack of any concrete malpractice reform.

The American Association of Clinical Urologists (AACU), the American Urological Association (AUA), and the Large Urology Group Practice Association (LUGPA) issued a joint statement, noting that "we are concerned that there are key aspects to this law that will, ultimately, hurt this nation's ability to provide widespread care for its citizens," including the IPAB. Mr. Shalgian said that the IPAB has been an issue for the ACS since it was first proposed.

At a press briefing called by the Republican Doctors Caucus, Rep. Phil Gingrey (R-Ga.), an ob.gyn., said that he and his fellow caucus members would work to overturn most if not all of the ACA, starting with the IPAB.

Some of Rep. Gingrey's colleagues were adamant that they'd do everything possible to overturn the law. Rep. Tom Price (R-Ga.), an orthopedic surgeon, said that the ACA "violates accessibility, violates affordability, violates quality, violates choices."

Rep. Paul Broun (R-Ga.) called the Act a "destroyer." He said it would "destroy a patient's ability to go to see a doctor and get the quality care they desperately need." Added Dr. Broun, "Obamacare must be repealed. It must be replaced with some policy that will make health care cheaper for everyone, provide coverage for all Americans, and save Medicare from going broke."

With the Supreme Court's efforts in the rear-view mirror, Republicans renewed their vow to repeal all or part of the ACA; however, that's unlikely to happen as long as Democrats maintain control of the Senate and the White House.

If Republicans win a majority in the Senate in November, and if Mitt Romney wins the presidential election, there could be major change.

In the meantime, most physician groups said they would work to fix the parts of the law that were objectionable.

Mr. Shalgian said that the ACS will be exploring options for medical liability reform during the annual Clinical Congress in Chicago.

Dr. Stream of the AAFP said that such reform is essential. "The [ACA] provides a foundation for reforming our health care system, but much work still lies ahead including a permanent replacement for the Sustainable Growth Rate formula and meaningful medical liability reform," he said.

Dr. Bronson of the ACP said that the organization realizes that "even with the Supreme Court's ruling, the political debate over the ACA continues and that its future is a major issue in the 2012 election."

He added, "We hope that a day will come when the debate will no longer be polarized between repeal on one hand, or keeping the law exactly as it is on the other, but on preserving all of the good things that it does while making needed improvements," among which would be "meaningful reforms to the medical liability system."

CHICAGO ? The new oral anticoagulants for stroke prevention in atrial fibrillation may be garnering all the buzz, but don?t count out the old standby warfarin yet.

"It?s not just a knee-jerk reaction that all patients should be switched to the new agents. It?s dependent upon how well you as a physician are managing your patients on warfarin," Dr. Jack E. Ansell asserted at the annual meeting of the American College of Cardiology.

"Warfarin therapy is all about management. If it?s not managed well, you can compare it to anything, and anything is going to be better. And if it?s managed very well, then it?s very difficult to beat warfarin therapy," said Dr. Ansell, who is the chairman of the department of medicine at Lenox Hill Hospital in New York.

A growing body of evidence indicates that the new standard in high-quality management of warfarin therapy involves patient self-testing of International Normalized Ratios (INR) at home using a fingerstick blood sample and a portable point-of-care device.

As a case in point: Dr. Ansell presented highlights of the new STABLE study, in which he and his coinvestigators conducted a retrospective analysis of the real-world experience of more than 29,000 warfarin-treated patients enrolled in a national commercial comprehensive self-test support service. The study was reported in JACC 2012 March 27 [doi: 10.1016/S0735-1097(12)61865-8]).

Patients who performed frequent self-testing ? meaning more than 80% of their self-testing was done on a weekly basis ? had a mean time spent in the therapeutic INR range (TTR) of 74%. That?s unprecedented, he said.

By comparison, in the pivotal RE-LY randomized trial for dabigatran (Pradaxa), the control group on warfarin had a TTR of 64% (N. Engl. J. Med. 2009;361:1139-51). In the ROCKET-AF trial of rivaroxaban (Xarelto), warfarin controls had a TTR of 55% (N. Engl. J. Med. 2011;365:883-91). And in the ARISTOTLE study of apixaban (Eliquis), an agent expected to soon receive Food and Drug Administration marketing approval, the warfarin control group had a TTR of 62% (N. Engl. J. Med. 2011;365:981-92).

In all these major randomized trials involving the novel oral anticoagulants, patients assigned to warfarin were closely managed, but in traditional fashion ? home self-testing wasn?t involved.

In contrast, in the STABLE study, the overall TTR, including those patients who self-tested variably and inconsistently, was still 69.7%.

"This is important because the cost-effectiveness analyses done with dabigatran and the other new anticoagulants suggest that when you get up to a TTR above 70% with warfarin, the cost-effectiveness of the new agents diminishes and warfarin actually becomes more cost-effective," according to Dr. Ansell.

A particularly impressive finding in STABLE was that patients who did weekly self-testing had a 2.3% incidence of critical value INR results, defined as an INR below 1.5 or greater than 5.0. "This is really a phenomenally low result," he commented. It represented a 48% reduction from the 4.4% incidence in patients with variable self-testing frequency.

Participants in the STABLE study tested themselves at home, but their warfarin dosing was managed by their referring physicians or anticoagulation clinics. Thus, an individual?s TTR reflected the warfarin management expertise of the referral source.

There are several reasons why home monitoring achieves better TTRs and ? as shown in other studies ? lower major bleeding and thrombotic event rates than with usual care or anticoagulation clinics not utilizing patient self-monitoring, Dr. Ansell said.

Home testing is more frequent, timely, and consistent, and the immediate feedback regarding INR results is likely to promote adherence.

A variant of patient self-testing starting to catch on in the United States is patient self-management. This entails teaching patients how to manage their own warfarin dose on the basis of their home INR measurements.

The most recent American College of Chest Physicians clinical practice guidelines on antithrombotic therapy for atrial fibrillation give patient self-management of warfarin therapy a class 2B recommendation, stating, "For patients treated with vitamin K antagonists who are motivated and can demonstrate competency in self-management strategies, including the self-testing equipment, we suggest patient self-management rather than the usual outpatient INR monitoring" (CHEST 2012;141: 2 suppl. e531S-e575S [doi: 10.1378/chest.11-2304]).

Session cochair Dr. Samuel Z. Goldhaber agreed with Dr. Ansell that warfarin still has a place in anticoagulation therapy. The fact that it costs as little as $4 per month while dabigatran, for example, retails for 60 times that amount, is not to be shrugged off in an era of runaway health care spending, he said.

Plus, warfarin, for all its drawbacks, is a known quantity backed by more than a half century of clinical experience.

"Even though warfarin can cause horrible complications, there are no more surprises left about what warfarin can do," observed Dr. Goldhaber, who is a professor of medicine at Harvard Medical School and director of the venous thromboembolism research group at Brigham and Women?s Hospital, Boston.

A potential game changer for warfarin is the possibility that rapid pharmacogenetic testing will enable physicians to improve upon the current method of warfarin dosing.

One advantage warfarin has is that bleeding episodes can be reversed by administration of vitamin K. In contrast, there is as yet no reliable means of reversing major bleeding in patients on the novel anticoagulants. But Dr. Lars Wallentin said this limitation of the new agents is outweighed by the consistent finding that they have lower rates of intracranial hemorrhage than those of warfarin.

"There is no antidote to warfarin that has proven to have any effect in patients with ICH. And there is no evidence as far as I can see that however you control INR you can reach as low a level of ICH as with these new agents. I think this is a specific downside of warfarin that we can?t get away from," said Dr. Wallentin, who is a professor of cardiology at Uppsala (Sweden) University.

The STABLE study was funded by Alere Home Monitoring, Inc. Dr. Ansell is a consultant to the company.

Dr. Goldhaber has served as a consultant to numerous pharmaceutical companies developing cardiovascular medications.

Dr. Wallentin was principal investigator in the ARISTOTLE study of apixaban, funded by Pfizer and Bristol Myers Squibb, and has served as a consultant to those and other pharmaceutical companies.

CHICAGO ? The new oral anticoagulants for stroke prevention in atrial fibrillation may be garnering all the buzz, but don?t count out the old standby warfarin yet.

"It?s not just a knee-jerk reaction that all patients should be switched to the new agents. It?s dependent upon how well you as a physician are managing your patients on warfarin," Dr. Jack E. Ansell asserted at the annual meeting of the American College of Cardiology.

"Warfarin therapy is all about management. If it?s not managed well, you can compare it to anything, and anything is going to be better. And if it?s managed very well, then it?s very difficult to beat warfarin therapy," said Dr. Ansell, who is the chairman of the department of medicine at Lenox Hill Hospital in New York.

A growing body of evidence indicates that the new standard in high-quality management of warfarin therapy involves patient self-testing of International Normalized Ratios (INR) at home using a fingerstick blood sample and a portable point-of-care device.

As a case in point: Dr. Ansell presented highlights of the new STABLE study, in which he and his coinvestigators conducted a retrospective analysis of the real-world experience of more than 29,000 warfarin-treated patients enrolled in a national commercial comprehensive self-test support service. The study was reported in JACC 2012 March 27 [doi: 10.1016/S0735-1097(12)61865-8]).

Patients who performed frequent self-testing ? meaning more than 80% of their self-testing was done on a weekly basis ? had a mean time spent in the therapeutic INR range (TTR) of 74%. That?s unprecedented, he said.

By comparison, in the pivotal RE-LY randomized trial for dabigatran (Pradaxa), the control group on warfarin had a TTR of 64% (N. Engl. J. Med. 2009;361:1139-51). In the ROCKET-AF trial of rivaroxaban (Xarelto), warfarin controls had a TTR of 55% (N. Engl. J. Med. 2011;365:883-91). And in the ARISTOTLE study of apixaban (Eliquis), an agent expected to soon receive Food and Drug Administration marketing approval, the warfarin control group had a TTR of 62% (N. Engl. J. Med. 2011;365:981-92).

In all these major randomized trials involving the novel oral anticoagulants, patients assigned to warfarin were closely managed, but in traditional fashion ? home self-testing wasn?t involved.

In contrast, in the STABLE study, the overall TTR, including those patients who self-tested variably and inconsistently, was still 69.7%.

"This is important because the cost-effectiveness analyses done with dabigatran and the other new anticoagulants suggest that when you get up to a TTR above 70% with warfarin, the cost-effectiveness of the new agents diminishes and warfarin actually becomes more cost-effective," according to Dr. Ansell.

A particularly impressive finding in STABLE was that patients who did weekly self-testing had a 2.3% incidence of critical value INR results, defined as an INR below 1.5 or greater than 5.0. "This is really a phenomenally low result," he commented. It represented a 48% reduction from the 4.4% incidence in patients with variable self-testing frequency.

Participants in the STABLE study tested themselves at home, but their warfarin dosing was managed by their referring physicians or anticoagulation clinics. Thus, an individual?s TTR reflected the warfarin management expertise of the referral source.

There are several reasons why home monitoring achieves better TTRs and ? as shown in other studies ? lower major bleeding and thrombotic event rates than with usual care or anticoagulation clinics not utilizing patient self-monitoring, Dr. Ansell said.

Home testing is more frequent, timely, and consistent, and the immediate feedback regarding INR results is likely to promote adherence.

A variant of patient self-testing starting to catch on in the United States is patient self-management. This entails teaching patients how to manage their own warfarin dose on the basis of their home INR measurements.

The most recent American College of Chest Physicians clinical practice guidelines on antithrombotic therapy for atrial fibrillation give patient self-management of warfarin therapy a class 2B recommendation, stating, "For patients treated with vitamin K antagonists who are motivated and can demonstrate competency in self-management strategies, including the self-testing equipment, we suggest patient self-management rather than the usual outpatient INR monitoring" (CHEST 2012;141: 2 suppl. e531S-e575S [doi: 10.1378/chest.11-2304]).

Session cochair Dr. Samuel Z. Goldhaber agreed with Dr. Ansell that warfarin still has a place in anticoagulation therapy. The fact that it costs as little as $4 per month while dabigatran, for example, retails for 60 times that amount, is not to be shrugged off in an era of runaway health care spending, he said.

Plus, warfarin, for all its drawbacks, is a known quantity backed by more than a half century of clinical experience.

"Even though warfarin can cause horrible complications, there are no more surprises left about what warfarin can do," observed Dr. Goldhaber, who is a professor of medicine at Harvard Medical School and director of the venous thromboembolism research group at Brigham and Women?s Hospital, Boston.

A potential game changer for warfarin is the possibility that rapid pharmacogenetic testing will enable physicians to improve upon the current method of warfarin dosing.

One advantage warfarin has is that bleeding episodes can be reversed by administration of vitamin K. In contrast, there is as yet no reliable means of reversing major bleeding in patients on the novel anticoagulants. But Dr. Lars Wallentin said this limitation of the new agents is outweighed by the consistent finding that they have lower rates of intracranial hemorrhage than those of warfarin.

"There is no antidote to warfarin that has proven to have any effect in patients with ICH. And there is no evidence as far as I can see that however you control INR you can reach as low a level of ICH as with these new agents. I think this is a specific downside of warfarin that we can?t get away from," said Dr. Wallentin, who is a professor of cardiology at Uppsala (Sweden) University.

The STABLE study was funded by Alere Home Monitoring, Inc. Dr. Ansell is a consultant to the company.

Dr. Goldhaber has served as a consultant to numerous pharmaceutical companies developing cardiovascular medications.

Dr. Wallentin was principal investigator in the ARISTOTLE study of apixaban, funded by Pfizer and Bristol Myers Squibb, and has served as a consultant to those and other pharmaceutical companies.

CHICAGO ? The new oral anticoagulants for stroke prevention in atrial fibrillation may be garnering all the buzz, but don?t count out the old standby warfarin yet.

"It?s not just a knee-jerk reaction that all patients should be switched to the new agents. It?s dependent upon how well you as a physician are managing your patients on warfarin," Dr. Jack E. Ansell asserted at the annual meeting of the American College of Cardiology.

"Warfarin therapy is all about management. If it?s not managed well, you can compare it to anything, and anything is going to be better. And if it?s managed very well, then it?s very difficult to beat warfarin therapy," said Dr. Ansell, who is the chairman of the department of medicine at Lenox Hill Hospital in New York.

A growing body of evidence indicates that the new standard in high-quality management of warfarin therapy involves patient self-testing of International Normalized Ratios (INR) at home using a fingerstick blood sample and a portable point-of-care device.

As a case in point: Dr. Ansell presented highlights of the new STABLE study, in which he and his coinvestigators conducted a retrospective analysis of the real-world experience of more than 29,000 warfarin-treated patients enrolled in a national commercial comprehensive self-test support service. The study was reported in JACC 2012 March 27 [doi: 10.1016/S0735-1097(12)61865-8]).

Patients who performed frequent self-testing ? meaning more than 80% of their self-testing was done on a weekly basis ? had a mean time spent in the therapeutic INR range (TTR) of 74%. That?s unprecedented, he said.

By comparison, in the pivotal RE-LY randomized trial for dabigatran (Pradaxa), the control group on warfarin had a TTR of 64% (N. Engl. J. Med. 2009;361:1139-51). In the ROCKET-AF trial of rivaroxaban (Xarelto), warfarin controls had a TTR of 55% (N. Engl. J. Med. 2011;365:883-91). And in the ARISTOTLE study of apixaban (Eliquis), an agent expected to soon receive Food and Drug Administration marketing approval, the warfarin control group had a TTR of 62% (N. Engl. J. Med. 2011;365:981-92).

In all these major randomized trials involving the novel oral anticoagulants, patients assigned to warfarin were closely managed, but in traditional fashion ? home self-testing wasn?t involved.

In contrast, in the STABLE study, the overall TTR, including those patients who self-tested variably and inconsistently, was still 69.7%.

"This is important because the cost-effectiveness analyses done with dabigatran and the other new anticoagulants suggest that when you get up to a TTR above 70% with warfarin, the cost-effectiveness of the new agents diminishes and warfarin actually becomes more cost-effective," according to Dr. Ansell.

A particularly impressive finding in STABLE was that patients who did weekly self-testing had a 2.3% incidence of critical value INR results, defined as an INR below 1.5 or greater than 5.0. "This is really a phenomenally low result," he commented. It represented a 48% reduction from the 4.4% incidence in patients with variable self-testing frequency.

Participants in the STABLE study tested themselves at home, but their warfarin dosing was managed by their referring physicians or anticoagulation clinics. Thus, an individual?s TTR reflected the warfarin management expertise of the referral source.

There are several reasons why home monitoring achieves better TTRs and ? as shown in other studies ? lower major bleeding and thrombotic event rates than with usual care or anticoagulation clinics not utilizing patient self-monitoring, Dr. Ansell said.

Home testing is more frequent, timely, and consistent, and the immediate feedback regarding INR results is likely to promote adherence.

A variant of patient self-testing starting to catch on in the United States is patient self-management. This entails teaching patients how to manage their own warfarin dose on the basis of their home INR measurements.

The most recent American College of Chest Physicians clinical practice guidelines on antithrombotic therapy for atrial fibrillation give patient self-management of warfarin therapy a class 2B recommendation, stating, "For patients treated with vitamin K antagonists who are motivated and can demonstrate competency in self-management strategies, including the self-testing equipment, we suggest patient self-management rather than the usual outpatient INR monitoring" (CHEST 2012;141: 2 suppl. e531S-e575S [doi: 10.1378/chest.11-2304]).

Session cochair Dr. Samuel Z. Goldhaber agreed with Dr. Ansell that warfarin still has a place in anticoagulation therapy. The fact that it costs as little as $4 per month while dabigatran, for example, retails for 60 times that amount, is not to be shrugged off in an era of runaway health care spending, he said.

Plus, warfarin, for all its drawbacks, is a known quantity backed by more than a half century of clinical experience.

"Even though warfarin can cause horrible complications, there are no more surprises left about what warfarin can do," observed Dr. Goldhaber, who is a professor of medicine at Harvard Medical School and director of the venous thromboembolism research group at Brigham and Women?s Hospital, Boston.

A potential game changer for warfarin is the possibility that rapid pharmacogenetic testing will enable physicians to improve upon the current method of warfarin dosing.

One advantage warfarin has is that bleeding episodes can be reversed by administration of vitamin K. In contrast, there is as yet no reliable means of reversing major bleeding in patients on the novel anticoagulants. But Dr. Lars Wallentin said this limitation of the new agents is outweighed by the consistent finding that they have lower rates of intracranial hemorrhage than those of warfarin.

"There is no antidote to warfarin that has proven to have any effect in patients with ICH. And there is no evidence as far as I can see that however you control INR you can reach as low a level of ICH as with these new agents. I think this is a specific downside of warfarin that we can?t get away from," said Dr. Wallentin, who is a professor of cardiology at Uppsala (Sweden) University.

The STABLE study was funded by Alere Home Monitoring, Inc. Dr. Ansell is a consultant to the company.

Dr. Goldhaber has served as a consultant to numerous pharmaceutical companies developing cardiovascular medications.

Dr. Wallentin was principal investigator in the ARISTOTLE study of apixaban, funded by Pfizer and Bristol Myers Squibb, and has served as a consultant to those and other pharmaceutical companies.