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Official Newspaper of the American College of Surgeons
Frail elders at high mortality risk in the year following surgery
SAN DIEGO – Frail elderly patients face a significantly increased risk of mortality in the year after undergoing major elective noncardiac surgery, a large study from Canada showed.
“The current literature on perioperative frailty clearly shows that being frail before surgery substantially increases your risk of adverse postoperative outcomes,” Dr. Daniel I. McIsaac said in an interview prior to the annual meeting of the American Society of Anesthesiologists, where the study was presented. “In fact, frailty may underlie a lot of the associations between advanced age and adverse postoperative outcomes. Frailty increases in prevalence with increasing age, and as we all know, the population is aging. Therefore, we expect to see an increasing number of frail patients coming for surgery.”
In an effort to determine the risk of 1-year mortality in frail elderly patients having major elective surgery, the researchers used population-based health administrative data in Ontario, to identify 202,811 patients over the age of 65 who had intermediate- to high-risk elective noncardiac surgery between 2002 and 2012. They used the Johns Hopkins Adjusted Clinical Groups (ACG) frailty indicator and captured all deaths that occurred within 1 year of surgery. Proportional hazards regression models adjusted for age, gender, and socioeconomic status were used to evaluate the impact of frailty on 1-year postoperative mortality.
Of the 202,811 patients, 6,289 (3.1%) were frail, reported Dr. McIsaac of the department of anesthesiology at the University of Ottawa. The 1-year postoperative mortality was 13.6% among frail patients, compared with 4.8% of nonfrail patients, for an adjusted hazard ratio of 2.23. Mortality was higher among frail patients for all types of surgery, compared with their nonfrail counterparts, with the exception of pancreaticoduodenectomy. Frailty had the strongest impact on the risk of mortality after total joint arthroplasty (adjusted hazard ratio of 3.79 for hip replacement and adjusted HR of 2.68 for knee replacement).
The risk of postoperative mortality for frail patients was much higher than for nonfrail patients in the early time period after surgery, especially during the first postoperative week. “Depending on how you control for other variables, a frail patient was 13-35 times more likely to die in the week after surgery than a nonfrail patient of the same age having the same surgery,” said Dr. McIsaac, who is also a staff anesthesiologist at the Ottawa Hospital. “This makes a lot of sense; frail patients are vulnerable to stressors, and surgery puts an enormous physiological stress on even healthy patients. Future work clearly needs to focus [on] addressing this high-risk time in the immediate postoperative period.”
He acknowledged certain limitations of the study, including its reliance on health administrative data and the fact that frailty “is a challenging exposure to study because there are a plethora of instruments that can be used to call someone frail. We used a validated set of frailty-defining diagnoses that have been shown to identify people with multidimensional frailty. That said, you can’t necessarily generalize our findings to patients identified as frail using other instruments.”
The findings, Dr. McIsaac concluded, suggest that clinicians should focus on identifying frail patients prior to surgery, “support them to ensure that they are more likely to derive benefit from surgery than harm, and focus on optimizing their care after surgery to address this early mortality risk.”
The study was funded by departments of anesthesiology at the University of Ottawa and at the Ottawa Hospital. Dr. McIsaac reported having no financial disclosures.
SAN DIEGO – Frail elderly patients face a significantly increased risk of mortality in the year after undergoing major elective noncardiac surgery, a large study from Canada showed.
“The current literature on perioperative frailty clearly shows that being frail before surgery substantially increases your risk of adverse postoperative outcomes,” Dr. Daniel I. McIsaac said in an interview prior to the annual meeting of the American Society of Anesthesiologists, where the study was presented. “In fact, frailty may underlie a lot of the associations between advanced age and adverse postoperative outcomes. Frailty increases in prevalence with increasing age, and as we all know, the population is aging. Therefore, we expect to see an increasing number of frail patients coming for surgery.”
In an effort to determine the risk of 1-year mortality in frail elderly patients having major elective surgery, the researchers used population-based health administrative data in Ontario, to identify 202,811 patients over the age of 65 who had intermediate- to high-risk elective noncardiac surgery between 2002 and 2012. They used the Johns Hopkins Adjusted Clinical Groups (ACG) frailty indicator and captured all deaths that occurred within 1 year of surgery. Proportional hazards regression models adjusted for age, gender, and socioeconomic status were used to evaluate the impact of frailty on 1-year postoperative mortality.
Of the 202,811 patients, 6,289 (3.1%) were frail, reported Dr. McIsaac of the department of anesthesiology at the University of Ottawa. The 1-year postoperative mortality was 13.6% among frail patients, compared with 4.8% of nonfrail patients, for an adjusted hazard ratio of 2.23. Mortality was higher among frail patients for all types of surgery, compared with their nonfrail counterparts, with the exception of pancreaticoduodenectomy. Frailty had the strongest impact on the risk of mortality after total joint arthroplasty (adjusted hazard ratio of 3.79 for hip replacement and adjusted HR of 2.68 for knee replacement).
The risk of postoperative mortality for frail patients was much higher than for nonfrail patients in the early time period after surgery, especially during the first postoperative week. “Depending on how you control for other variables, a frail patient was 13-35 times more likely to die in the week after surgery than a nonfrail patient of the same age having the same surgery,” said Dr. McIsaac, who is also a staff anesthesiologist at the Ottawa Hospital. “This makes a lot of sense; frail patients are vulnerable to stressors, and surgery puts an enormous physiological stress on even healthy patients. Future work clearly needs to focus [on] addressing this high-risk time in the immediate postoperative period.”
He acknowledged certain limitations of the study, including its reliance on health administrative data and the fact that frailty “is a challenging exposure to study because there are a plethora of instruments that can be used to call someone frail. We used a validated set of frailty-defining diagnoses that have been shown to identify people with multidimensional frailty. That said, you can’t necessarily generalize our findings to patients identified as frail using other instruments.”
The findings, Dr. McIsaac concluded, suggest that clinicians should focus on identifying frail patients prior to surgery, “support them to ensure that they are more likely to derive benefit from surgery than harm, and focus on optimizing their care after surgery to address this early mortality risk.”
The study was funded by departments of anesthesiology at the University of Ottawa and at the Ottawa Hospital. Dr. McIsaac reported having no financial disclosures.
SAN DIEGO – Frail elderly patients face a significantly increased risk of mortality in the year after undergoing major elective noncardiac surgery, a large study from Canada showed.
“The current literature on perioperative frailty clearly shows that being frail before surgery substantially increases your risk of adverse postoperative outcomes,” Dr. Daniel I. McIsaac said in an interview prior to the annual meeting of the American Society of Anesthesiologists, where the study was presented. “In fact, frailty may underlie a lot of the associations between advanced age and adverse postoperative outcomes. Frailty increases in prevalence with increasing age, and as we all know, the population is aging. Therefore, we expect to see an increasing number of frail patients coming for surgery.”
In an effort to determine the risk of 1-year mortality in frail elderly patients having major elective surgery, the researchers used population-based health administrative data in Ontario, to identify 202,811 patients over the age of 65 who had intermediate- to high-risk elective noncardiac surgery between 2002 and 2012. They used the Johns Hopkins Adjusted Clinical Groups (ACG) frailty indicator and captured all deaths that occurred within 1 year of surgery. Proportional hazards regression models adjusted for age, gender, and socioeconomic status were used to evaluate the impact of frailty on 1-year postoperative mortality.
Of the 202,811 patients, 6,289 (3.1%) were frail, reported Dr. McIsaac of the department of anesthesiology at the University of Ottawa. The 1-year postoperative mortality was 13.6% among frail patients, compared with 4.8% of nonfrail patients, for an adjusted hazard ratio of 2.23. Mortality was higher among frail patients for all types of surgery, compared with their nonfrail counterparts, with the exception of pancreaticoduodenectomy. Frailty had the strongest impact on the risk of mortality after total joint arthroplasty (adjusted hazard ratio of 3.79 for hip replacement and adjusted HR of 2.68 for knee replacement).
The risk of postoperative mortality for frail patients was much higher than for nonfrail patients in the early time period after surgery, especially during the first postoperative week. “Depending on how you control for other variables, a frail patient was 13-35 times more likely to die in the week after surgery than a nonfrail patient of the same age having the same surgery,” said Dr. McIsaac, who is also a staff anesthesiologist at the Ottawa Hospital. “This makes a lot of sense; frail patients are vulnerable to stressors, and surgery puts an enormous physiological stress on even healthy patients. Future work clearly needs to focus [on] addressing this high-risk time in the immediate postoperative period.”
He acknowledged certain limitations of the study, including its reliance on health administrative data and the fact that frailty “is a challenging exposure to study because there are a plethora of instruments that can be used to call someone frail. We used a validated set of frailty-defining diagnoses that have been shown to identify people with multidimensional frailty. That said, you can’t necessarily generalize our findings to patients identified as frail using other instruments.”
The findings, Dr. McIsaac concluded, suggest that clinicians should focus on identifying frail patients prior to surgery, “support them to ensure that they are more likely to derive benefit from surgery than harm, and focus on optimizing their care after surgery to address this early mortality risk.”
The study was funded by departments of anesthesiology at the University of Ottawa and at the Ottawa Hospital. Dr. McIsaac reported having no financial disclosures.
AT THE ASA ANNUAL MEETING
Key clinical point: Frail elderly patients face an increased risk of mortality within 1 year of undergoing noncardiac surgery.
Major finding: The 1-year postoperative mortality was 13.6% among frail patients, compared with 4.8% of nonfrail patients, for an adjusted hazard ratio of 2.23.
Data source: A study of 202,811 patients over the age of 65 years who underwent noncardiac surgery between 2002 and 2012.
Disclosures: The study was funded by departments of anesthesiology at the University of Ottawa and at The Ottawa Hospital. Dr. McIsaac reported having no financial disclosures.
TCT: Paclitaxel-coated balloon delivers durable SFA patency
SAN FRANCISCO – Treatment of femoropopliteal arterial disease with a paclitaxel-coated balloon produced durable, 2-year benefits compared with conventional balloon angioplasty during extended follow-up of the pivotal trial that led to U.S. approval of this drug-coated balloon.
The durability of the benefit first seen after 1 year when follow-up continued out to 2 years was an important finding that distinguishes the IN.PACT Admiral paclitaxel-covered balloon used in the current study from the first and only other drug-covered balloon (DCB) approved for U.S. practice, the Lutonix 035 DCB.
“Not all drug-coated balloons are the same,” Dr. John R. Laird said while reporting the IN.PACT Admiral DCB results at the Transcatheter Cardiovascular Therapeutics annual meeting.
Although both the IN.PACT Admiral and Lutonix 035 DCB have paclitaxel coatings, the two devices differ by paclitaxel dose density on the balloon’s surface (3.5 mcg/mm2 and 2.0 mcg/mm2, respectively), type of excipient (carrier) used, and the balloon coating, noted Dr. Laird, professor and medical director of the Vascular Center at the University of California, Davis in Sacramento.
After the first year, primary patency ran 82% among the 220 patients randomized to the DCB and 52% in patients treated with percutaneous transluminal angioplasty, a statistically significant 30 percentage point difference in favor of the DCB. After 2 years, the rates were 79% in the DCB arm and 50% with a conventional balloon. “We saw no late catch-up that reduced the patency rate,” said Dr. Laird.
The INPACT SFA I(Randomized Trial of IN.PACT Admiral Drug Coated Balloon vs. Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease) trial enrolled 331 patients at 57 centers in the United States and Europe. Researchers reported the study’s primary efficacy and safety endpoints with 1-year follow-up earlier this year (Circulation. 2015 Feb 3;131:495-502). Concurrent with Dr. Laird’s report at the meeting, the 2-year results appeared online (J Amer Coll Card. 2015.doi:10.1016/j.jacc.2015.09.063).
Dr. Laird acknowledged that some types of stents also have shown good efficacy for treating femoropopliteal disease, but he had reservations about placing a stent when the DCB option exists.
“A lot of people have the sense that if we can avoid placing a stent in a femoral artery it helps preserve future treatment options for the patient. The problem with a stent is that once in-stent restenosis occurs in a leg artery, then the chances of getting a good result with an intravascular approach are poor,” Dr. Laird said at the meeting, sponsored by the Cardiovascular Research Foundation.
One potentially concerning finding from the 2-year follow-up was a statistically significant excess of all-cause mortality in the patients who received the DCB, with 16 deaths in the DCB arm and 1 death in the control, angioplasty arm. Dr. Laird dismissed the clinical importance of the finding, noting that all the deaths in the DCB arm had been independently adjudicated with none judged related to the device or procedure. In addition, the deaths occurred an average of 560 days following the procedure.
On Twitter @mitchelzoler
The IN.PACT Admiral paclitaxel-covered balloon provides a powerful new tool for treating superficial femoral artery and popliteal artery disease that works better than does a conventional balloon and avoids using a stent.
Not all drug-coated balloons (DCBs) are alike, even if they use the same antiproliferative drug, paclitaxel. The evidence suggests that the IN.PACT Admiral drug-coated balloon is superior to the performance of the Lutonix 035 DCB, although this has only been assessed in separate studies and not as a head-to-head comparison.
|
Dr. Gary Gershony |
Another option for treating superficial femoropopliteal disease is with any of a variety of stents. I think the general feeling among peripheral-artery specialists is that it’s better for patients to avoid having a stent permanently in their leg when other, equally-good options are available to try first. Sometimes placing a stent is unavoidable to produce a substantially better revascularization outcome, for example when a dissection occurs or for treating a significant residual stenosis.
The IN.PACT Admiral DCB has not yet been tested on complex or calcified lesions so its performance in those settings is not yet know. The basic message from this 2-year follow-up is that this paclitaxel-coated balloon had better results out to 2-years than a conventional balloon for lesions that were not especially complex and with an average length of 9 cm. For many patients with lesions like these a DCB is a good option because it may produce a durable result while maintaining the option to use a stent later if necessary.
Vascular specialists have been concerned about longer-term follow-up of the results from the IN.PACT SFA trial to see if a signal appeared of catchup restenosis between years 1 and 2. The results showed no evidence of this. It is reassuring to see this DCB technology can produce an effect that’s durable for 2 years without leaving behind a permanent implant. It strengthens the case for this particular DCB but should not be extrapolated to all drug-coated balloons or to all types of femoropopliteal lesions.
Dr. Gary Gershony is an interventional cardiologist and medical director of cardiovascular research, education and technology at John Muir Cardiovascular Institute of John Muir Health in Concord, Calif. He had no relevant disclosures. He made these comments as a discussant for the report and in an interview.
The IN.PACT Admiral paclitaxel-covered balloon provides a powerful new tool for treating superficial femoral artery and popliteal artery disease that works better than does a conventional balloon and avoids using a stent.
Not all drug-coated balloons (DCBs) are alike, even if they use the same antiproliferative drug, paclitaxel. The evidence suggests that the IN.PACT Admiral drug-coated balloon is superior to the performance of the Lutonix 035 DCB, although this has only been assessed in separate studies and not as a head-to-head comparison.
|
|
Dr. Gary Gershony |
Another option for treating superficial femoropopliteal disease is with any of a variety of stents. I think the general feeling among peripheral-artery specialists is that it’s better for patients to avoid having a stent permanently in their leg when other, equally-good options are available to try first. Sometimes placing a stent is unavoidable to produce a substantially better revascularization outcome, for example when a dissection occurs or for treating a significant residual stenosis.
The IN.PACT Admiral DCB has not yet been tested on complex or calcified lesions so its performance in those settings is not yet know. The basic message from this 2-year follow-up is that this paclitaxel-coated balloon had better results out to 2-years than a conventional balloon for lesions that were not especially complex and with an average length of 9 cm. For many patients with lesions like these a DCB is a good option because it may produce a durable result while maintaining the option to use a stent later if necessary.
Vascular specialists have been concerned about longer-term follow-up of the results from the IN.PACT SFA trial to see if a signal appeared of catchup restenosis between years 1 and 2. The results showed no evidence of this. It is reassuring to see this DCB technology can produce an effect that’s durable for 2 years without leaving behind a permanent implant. It strengthens the case for this particular DCB but should not be extrapolated to all drug-coated balloons or to all types of femoropopliteal lesions.
Dr. Gary Gershony is an interventional cardiologist and medical director of cardiovascular research, education and technology at John Muir Cardiovascular Institute of John Muir Health in Concord, Calif. He had no relevant disclosures. He made these comments as a discussant for the report and in an interview.
The IN.PACT Admiral paclitaxel-covered balloon provides a powerful new tool for treating superficial femoral artery and popliteal artery disease that works better than does a conventional balloon and avoids using a stent.
Not all drug-coated balloons (DCBs) are alike, even if they use the same antiproliferative drug, paclitaxel. The evidence suggests that the IN.PACT Admiral drug-coated balloon is superior to the performance of the Lutonix 035 DCB, although this has only been assessed in separate studies and not as a head-to-head comparison.
|
|
Dr. Gary Gershony |
Another option for treating superficial femoropopliteal disease is with any of a variety of stents. I think the general feeling among peripheral-artery specialists is that it’s better for patients to avoid having a stent permanently in their leg when other, equally-good options are available to try first. Sometimes placing a stent is unavoidable to produce a substantially better revascularization outcome, for example when a dissection occurs or for treating a significant residual stenosis.
The IN.PACT Admiral DCB has not yet been tested on complex or calcified lesions so its performance in those settings is not yet know. The basic message from this 2-year follow-up is that this paclitaxel-coated balloon had better results out to 2-years than a conventional balloon for lesions that were not especially complex and with an average length of 9 cm. For many patients with lesions like these a DCB is a good option because it may produce a durable result while maintaining the option to use a stent later if necessary.
Vascular specialists have been concerned about longer-term follow-up of the results from the IN.PACT SFA trial to see if a signal appeared of catchup restenosis between years 1 and 2. The results showed no evidence of this. It is reassuring to see this DCB technology can produce an effect that’s durable for 2 years without leaving behind a permanent implant. It strengthens the case for this particular DCB but should not be extrapolated to all drug-coated balloons or to all types of femoropopliteal lesions.
Dr. Gary Gershony is an interventional cardiologist and medical director of cardiovascular research, education and technology at John Muir Cardiovascular Institute of John Muir Health in Concord, Calif. He had no relevant disclosures. He made these comments as a discussant for the report and in an interview.
SAN FRANCISCO – Treatment of femoropopliteal arterial disease with a paclitaxel-coated balloon produced durable, 2-year benefits compared with conventional balloon angioplasty during extended follow-up of the pivotal trial that led to U.S. approval of this drug-coated balloon.
The durability of the benefit first seen after 1 year when follow-up continued out to 2 years was an important finding that distinguishes the IN.PACT Admiral paclitaxel-covered balloon used in the current study from the first and only other drug-covered balloon (DCB) approved for U.S. practice, the Lutonix 035 DCB.
“Not all drug-coated balloons are the same,” Dr. John R. Laird said while reporting the IN.PACT Admiral DCB results at the Transcatheter Cardiovascular Therapeutics annual meeting.
Although both the IN.PACT Admiral and Lutonix 035 DCB have paclitaxel coatings, the two devices differ by paclitaxel dose density on the balloon’s surface (3.5 mcg/mm2 and 2.0 mcg/mm2, respectively), type of excipient (carrier) used, and the balloon coating, noted Dr. Laird, professor and medical director of the Vascular Center at the University of California, Davis in Sacramento.
After the first year, primary patency ran 82% among the 220 patients randomized to the DCB and 52% in patients treated with percutaneous transluminal angioplasty, a statistically significant 30 percentage point difference in favor of the DCB. After 2 years, the rates were 79% in the DCB arm and 50% with a conventional balloon. “We saw no late catch-up that reduced the patency rate,” said Dr. Laird.
The INPACT SFA I(Randomized Trial of IN.PACT Admiral Drug Coated Balloon vs. Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease) trial enrolled 331 patients at 57 centers in the United States and Europe. Researchers reported the study’s primary efficacy and safety endpoints with 1-year follow-up earlier this year (Circulation. 2015 Feb 3;131:495-502). Concurrent with Dr. Laird’s report at the meeting, the 2-year results appeared online (J Amer Coll Card. 2015.doi:10.1016/j.jacc.2015.09.063).
Dr. Laird acknowledged that some types of stents also have shown good efficacy for treating femoropopliteal disease, but he had reservations about placing a stent when the DCB option exists.
“A lot of people have the sense that if we can avoid placing a stent in a femoral artery it helps preserve future treatment options for the patient. The problem with a stent is that once in-stent restenosis occurs in a leg artery, then the chances of getting a good result with an intravascular approach are poor,” Dr. Laird said at the meeting, sponsored by the Cardiovascular Research Foundation.
One potentially concerning finding from the 2-year follow-up was a statistically significant excess of all-cause mortality in the patients who received the DCB, with 16 deaths in the DCB arm and 1 death in the control, angioplasty arm. Dr. Laird dismissed the clinical importance of the finding, noting that all the deaths in the DCB arm had been independently adjudicated with none judged related to the device or procedure. In addition, the deaths occurred an average of 560 days following the procedure.
On Twitter @mitchelzoler
SAN FRANCISCO – Treatment of femoropopliteal arterial disease with a paclitaxel-coated balloon produced durable, 2-year benefits compared with conventional balloon angioplasty during extended follow-up of the pivotal trial that led to U.S. approval of this drug-coated balloon.
The durability of the benefit first seen after 1 year when follow-up continued out to 2 years was an important finding that distinguishes the IN.PACT Admiral paclitaxel-covered balloon used in the current study from the first and only other drug-covered balloon (DCB) approved for U.S. practice, the Lutonix 035 DCB.
“Not all drug-coated balloons are the same,” Dr. John R. Laird said while reporting the IN.PACT Admiral DCB results at the Transcatheter Cardiovascular Therapeutics annual meeting.
Although both the IN.PACT Admiral and Lutonix 035 DCB have paclitaxel coatings, the two devices differ by paclitaxel dose density on the balloon’s surface (3.5 mcg/mm2 and 2.0 mcg/mm2, respectively), type of excipient (carrier) used, and the balloon coating, noted Dr. Laird, professor and medical director of the Vascular Center at the University of California, Davis in Sacramento.
After the first year, primary patency ran 82% among the 220 patients randomized to the DCB and 52% in patients treated with percutaneous transluminal angioplasty, a statistically significant 30 percentage point difference in favor of the DCB. After 2 years, the rates were 79% in the DCB arm and 50% with a conventional balloon. “We saw no late catch-up that reduced the patency rate,” said Dr. Laird.
The INPACT SFA I(Randomized Trial of IN.PACT Admiral Drug Coated Balloon vs. Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease) trial enrolled 331 patients at 57 centers in the United States and Europe. Researchers reported the study’s primary efficacy and safety endpoints with 1-year follow-up earlier this year (Circulation. 2015 Feb 3;131:495-502). Concurrent with Dr. Laird’s report at the meeting, the 2-year results appeared online (J Amer Coll Card. 2015.doi:10.1016/j.jacc.2015.09.063).
Dr. Laird acknowledged that some types of stents also have shown good efficacy for treating femoropopliteal disease, but he had reservations about placing a stent when the DCB option exists.
“A lot of people have the sense that if we can avoid placing a stent in a femoral artery it helps preserve future treatment options for the patient. The problem with a stent is that once in-stent restenosis occurs in a leg artery, then the chances of getting a good result with an intravascular approach are poor,” Dr. Laird said at the meeting, sponsored by the Cardiovascular Research Foundation.
One potentially concerning finding from the 2-year follow-up was a statistically significant excess of all-cause mortality in the patients who received the DCB, with 16 deaths in the DCB arm and 1 death in the control, angioplasty arm. Dr. Laird dismissed the clinical importance of the finding, noting that all the deaths in the DCB arm had been independently adjudicated with none judged related to the device or procedure. In addition, the deaths occurred an average of 560 days following the procedure.
On Twitter @mitchelzoler
AT TCT 2015
Key clinical point: Two-year follow-up of paclitaxel-coated balloon treatment of femoropopliteal lesions showed durable and substantially better patency, compared with conventional balloon treatment.
Major finding: Two-year primary patency rate was 79% after treatment with the IN.PACT Admiral balloon and 50% with a conventional balloon.
Data source: INPACT SFA 1, a multicenter, randomized trial with 331 enrolled patients.
Disclosures: INPACT SFA I was sponsored by Medtronic, the company that markets the IN.PACT Admiral drug-coated balloon. Dr. Laird has been a consultant to Medtronic as well as to Bard, Abbott Vascular, Boston Scientific and Cordis. He also owns stock in several device companies.
TCT: Immobilized leaflets on bioprosthetic aortic valves trigger concern
SAN FRANCISCO – The newly discovered issue of reduced leaflet motion and possible thrombus on bioprosthetic aortic heart valves, called by one expert “an imaging observation of uncertain clinical significance,” nonetheless drew lots of attention at the Transcatheter Cardiovascular Therapeutics annual meeting. Reduced leaflet motion was the focus of the meeting’s opening session as well as a specially scheduled press conference.
Much of the attention dealt with clarifying the situation and calling for calm after patient concerns were aroused by a report on Oct. 5 that examination of detailed CT scans from small series of patients who had recently undergone aortic valve replacement showed reduced-motion or immobilized valve leaflets on some of the bioprosthetic valves. The pattern of the finding, made using four-dimensional CT imaging, indicated that reduced-motion leaflets did not occur, and possibly even resolved, when patients were on anticoagulant therapy, suggesting that leaflet immobilization involved thrombus. Also, reduced-motion leaflets appeared following both transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR), said Dr. Raj R. Makkar.
Dr. Makkar summarized his CT findings in several talks during the meeting and also in a report published a few days before the meeting (N Engl J Med. 2015 Oct 5. doi: 10.1056/NEJMoa1509233).
“We started with what we thought was an imaging artifact and established that is it real. We also established with reasonable certainty that it is related to thrombus,” said Dr. Makkar, professor at the University of California, Los Angeles, and director of the Cardiovascular Interventional Center at Cedars-Sinai Medical Center in Los Angeles. The evidence also indicates that this is a class effect that occurs with all types of TAVR systems as well as surgically placed valves.
What the evidence so far does not indicate is that patients with reduced-motion leaflets face any clinical consequence nor need for routine CT imaging of a newly-placed TAVR or SAVR valve. Also no need for routine anticoagulant therapy instead of standard treatment with dual antiplatelet therapy for several months following placement of a bioprosthetic aortic valve. “We should not make the leap that following TAVR, everyone should be on an anticoagulant” because anticoagulant treatment carries it own risks, said Dr. Makkar, who noted that roughly a quarter of TAVR patients receive anticoagulant treatment because of another indication, such as atrial fibrillation.
“The study did not show a temporal or causal relationship between the imaging findings and stroke. That needs emphasis,” commented Dr. Susheel Kodali, codirector of the Heart Valve Center at the Center for Interventional Vascular Therapy at Columbia University in New York. The possible link between leaflet immobility and strokes or other neurologic events “warrants further study,” as the data that Dr. Makkar reported involved a total of only six strokes or transient ischemic attacks. Data from all the TAVR trials and registries reported so far showed “no late signal of stroke,” said Dr. Kodali, who added that SAVR had a 30-year record of net benefit for appropriate patients.
“Is valve-leaflet thickening an important controversy or much ado about nothing?” wondered Dr. Martin B. Leon, director of the Center for Interventional Vascular Therapy of Columbia University.
“Patients should not feel at risk, and there is no need to do anything differently” for the time being in routine practice, commented Dr. Jeffrey J. Popma, professor at Harvard Medical School and director of interventional cardiology at Beth Israel Deaconess Medical Center, both in Boston.
Dr. Makkar said that in the days following the publication of his report, he had “a lot of phone calls and time spent allaying anxiety in patients and reassuring them.”
One reason why these leaflet-motion abnormalities may have shown up on CT examinations recently is that “the cameras have gotten better,” said Dr. Jonathon A. Leipsic, codirector of advanced cardiac imaging at the Providence Health Care Heart Center at St. Paul’s Hospital in Vancouver. Dr. Leipsic also highlighted that with state-of-the-art CT images, immobilized leaflets are easy to identify.
Despite that, Dr. Popma stressed that standardized imaging protocols are needed going forward to produce reliable incidence data.
The data that Dr. Makkar reported came from a review of four-dimensional CT imaging done on 187 replacement aortic valves, usually within 3 months of placement. Images for 55 aortic valves came from the device-approval trial for a new TAVR system, taken 30 days after patients underwent TAVR with any of three types of systems. The images showed reduced leaflet motion in 22 valves (40%).
CT images for another 132 valves came from a Cedar’s-Sinai registry and a second, independent registry maintained in Denmark. CT images showed that 17 (13%) of the replaced aortic valves showed a leaflet-motion abnormality, including two valves placed using SAVR. Half the registry patients had undergone CT imaging within 88 days of valve replacement. The only signal of a clinical outcome linked with reduced-motion leaflets was a small increase in the incidence of transient ischemic attacks, but Dr. Makkar cautioned that transient ischemic attacks “are hard to adjudicate.”
Dr. Makkar’s report was “a small but important study, one of the first reports of this phenomenon. You don’t want to lose sight of all the evidence of patient benefit” from aortic valve replacement, stressed Dr. Kodali at the meeting, sponsored by the Cardiovascular Research Foundation. “This needs to be investigated further, probably by a Food and Drug Administration–mandated trial with CT imaging.”
“Aortic valves are lifesaving devices. The last thing that should happen is patients not getting their aortic valves replaced” when their condition demands it, Dr. Makkar said.
The PORTICO IDE study and RESOLVE registry were funded by St. Jude. Dr. Makkar has received honoraria and research support from St. Jude, lecture fees from Edwards Lifesciences, research grants from Edwards and Medtronic, and has an equity interest in Entourage. Dr. Kodali has been a consultant to Edwards Lifesciences and Claret Medical and has an equity interest in Thubrikar Aortic Valve. Dr. Leon has been a consultant to Edwards. Dr. Popma has been a consultant to Abbott Laboratories, Boston Scientific, and St. Jude, and he has been a speaker for and received grants from Medtronic, Dr. Leipsic has been a consultant to Edwards and Heartflow and received grants from Edwards, Neovasc, and Tendyne.
On Twitter @mitchelzoler
SAN FRANCISCO – The newly discovered issue of reduced leaflet motion and possible thrombus on bioprosthetic aortic heart valves, called by one expert “an imaging observation of uncertain clinical significance,” nonetheless drew lots of attention at the Transcatheter Cardiovascular Therapeutics annual meeting. Reduced leaflet motion was the focus of the meeting’s opening session as well as a specially scheduled press conference.
Much of the attention dealt with clarifying the situation and calling for calm after patient concerns were aroused by a report on Oct. 5 that examination of detailed CT scans from small series of patients who had recently undergone aortic valve replacement showed reduced-motion or immobilized valve leaflets on some of the bioprosthetic valves. The pattern of the finding, made using four-dimensional CT imaging, indicated that reduced-motion leaflets did not occur, and possibly even resolved, when patients were on anticoagulant therapy, suggesting that leaflet immobilization involved thrombus. Also, reduced-motion leaflets appeared following both transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR), said Dr. Raj R. Makkar.
Dr. Makkar summarized his CT findings in several talks during the meeting and also in a report published a few days before the meeting (N Engl J Med. 2015 Oct 5. doi: 10.1056/NEJMoa1509233).
“We started with what we thought was an imaging artifact and established that is it real. We also established with reasonable certainty that it is related to thrombus,” said Dr. Makkar, professor at the University of California, Los Angeles, and director of the Cardiovascular Interventional Center at Cedars-Sinai Medical Center in Los Angeles. The evidence also indicates that this is a class effect that occurs with all types of TAVR systems as well as surgically placed valves.
What the evidence so far does not indicate is that patients with reduced-motion leaflets face any clinical consequence nor need for routine CT imaging of a newly-placed TAVR or SAVR valve. Also no need for routine anticoagulant therapy instead of standard treatment with dual antiplatelet therapy for several months following placement of a bioprosthetic aortic valve. “We should not make the leap that following TAVR, everyone should be on an anticoagulant” because anticoagulant treatment carries it own risks, said Dr. Makkar, who noted that roughly a quarter of TAVR patients receive anticoagulant treatment because of another indication, such as atrial fibrillation.
“The study did not show a temporal or causal relationship between the imaging findings and stroke. That needs emphasis,” commented Dr. Susheel Kodali, codirector of the Heart Valve Center at the Center for Interventional Vascular Therapy at Columbia University in New York. The possible link between leaflet immobility and strokes or other neurologic events “warrants further study,” as the data that Dr. Makkar reported involved a total of only six strokes or transient ischemic attacks. Data from all the TAVR trials and registries reported so far showed “no late signal of stroke,” said Dr. Kodali, who added that SAVR had a 30-year record of net benefit for appropriate patients.
“Is valve-leaflet thickening an important controversy or much ado about nothing?” wondered Dr. Martin B. Leon, director of the Center for Interventional Vascular Therapy of Columbia University.
“Patients should not feel at risk, and there is no need to do anything differently” for the time being in routine practice, commented Dr. Jeffrey J. Popma, professor at Harvard Medical School and director of interventional cardiology at Beth Israel Deaconess Medical Center, both in Boston.
Dr. Makkar said that in the days following the publication of his report, he had “a lot of phone calls and time spent allaying anxiety in patients and reassuring them.”
One reason why these leaflet-motion abnormalities may have shown up on CT examinations recently is that “the cameras have gotten better,” said Dr. Jonathon A. Leipsic, codirector of advanced cardiac imaging at the Providence Health Care Heart Center at St. Paul’s Hospital in Vancouver. Dr. Leipsic also highlighted that with state-of-the-art CT images, immobilized leaflets are easy to identify.
Despite that, Dr. Popma stressed that standardized imaging protocols are needed going forward to produce reliable incidence data.
The data that Dr. Makkar reported came from a review of four-dimensional CT imaging done on 187 replacement aortic valves, usually within 3 months of placement. Images for 55 aortic valves came from the device-approval trial for a new TAVR system, taken 30 days after patients underwent TAVR with any of three types of systems. The images showed reduced leaflet motion in 22 valves (40%).
CT images for another 132 valves came from a Cedar’s-Sinai registry and a second, independent registry maintained in Denmark. CT images showed that 17 (13%) of the replaced aortic valves showed a leaflet-motion abnormality, including two valves placed using SAVR. Half the registry patients had undergone CT imaging within 88 days of valve replacement. The only signal of a clinical outcome linked with reduced-motion leaflets was a small increase in the incidence of transient ischemic attacks, but Dr. Makkar cautioned that transient ischemic attacks “are hard to adjudicate.”
Dr. Makkar’s report was “a small but important study, one of the first reports of this phenomenon. You don’t want to lose sight of all the evidence of patient benefit” from aortic valve replacement, stressed Dr. Kodali at the meeting, sponsored by the Cardiovascular Research Foundation. “This needs to be investigated further, probably by a Food and Drug Administration–mandated trial with CT imaging.”
“Aortic valves are lifesaving devices. The last thing that should happen is patients not getting their aortic valves replaced” when their condition demands it, Dr. Makkar said.
The PORTICO IDE study and RESOLVE registry were funded by St. Jude. Dr. Makkar has received honoraria and research support from St. Jude, lecture fees from Edwards Lifesciences, research grants from Edwards and Medtronic, and has an equity interest in Entourage. Dr. Kodali has been a consultant to Edwards Lifesciences and Claret Medical and has an equity interest in Thubrikar Aortic Valve. Dr. Leon has been a consultant to Edwards. Dr. Popma has been a consultant to Abbott Laboratories, Boston Scientific, and St. Jude, and he has been a speaker for and received grants from Medtronic, Dr. Leipsic has been a consultant to Edwards and Heartflow and received grants from Edwards, Neovasc, and Tendyne.
On Twitter @mitchelzoler
SAN FRANCISCO – The newly discovered issue of reduced leaflet motion and possible thrombus on bioprosthetic aortic heart valves, called by one expert “an imaging observation of uncertain clinical significance,” nonetheless drew lots of attention at the Transcatheter Cardiovascular Therapeutics annual meeting. Reduced leaflet motion was the focus of the meeting’s opening session as well as a specially scheduled press conference.
Much of the attention dealt with clarifying the situation and calling for calm after patient concerns were aroused by a report on Oct. 5 that examination of detailed CT scans from small series of patients who had recently undergone aortic valve replacement showed reduced-motion or immobilized valve leaflets on some of the bioprosthetic valves. The pattern of the finding, made using four-dimensional CT imaging, indicated that reduced-motion leaflets did not occur, and possibly even resolved, when patients were on anticoagulant therapy, suggesting that leaflet immobilization involved thrombus. Also, reduced-motion leaflets appeared following both transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR), said Dr. Raj R. Makkar.
Dr. Makkar summarized his CT findings in several talks during the meeting and also in a report published a few days before the meeting (N Engl J Med. 2015 Oct 5. doi: 10.1056/NEJMoa1509233).
“We started with what we thought was an imaging artifact and established that is it real. We also established with reasonable certainty that it is related to thrombus,” said Dr. Makkar, professor at the University of California, Los Angeles, and director of the Cardiovascular Interventional Center at Cedars-Sinai Medical Center in Los Angeles. The evidence also indicates that this is a class effect that occurs with all types of TAVR systems as well as surgically placed valves.
What the evidence so far does not indicate is that patients with reduced-motion leaflets face any clinical consequence nor need for routine CT imaging of a newly-placed TAVR or SAVR valve. Also no need for routine anticoagulant therapy instead of standard treatment with dual antiplatelet therapy for several months following placement of a bioprosthetic aortic valve. “We should not make the leap that following TAVR, everyone should be on an anticoagulant” because anticoagulant treatment carries it own risks, said Dr. Makkar, who noted that roughly a quarter of TAVR patients receive anticoagulant treatment because of another indication, such as atrial fibrillation.
“The study did not show a temporal or causal relationship between the imaging findings and stroke. That needs emphasis,” commented Dr. Susheel Kodali, codirector of the Heart Valve Center at the Center for Interventional Vascular Therapy at Columbia University in New York. The possible link between leaflet immobility and strokes or other neurologic events “warrants further study,” as the data that Dr. Makkar reported involved a total of only six strokes or transient ischemic attacks. Data from all the TAVR trials and registries reported so far showed “no late signal of stroke,” said Dr. Kodali, who added that SAVR had a 30-year record of net benefit for appropriate patients.
“Is valve-leaflet thickening an important controversy or much ado about nothing?” wondered Dr. Martin B. Leon, director of the Center for Interventional Vascular Therapy of Columbia University.
“Patients should not feel at risk, and there is no need to do anything differently” for the time being in routine practice, commented Dr. Jeffrey J. Popma, professor at Harvard Medical School and director of interventional cardiology at Beth Israel Deaconess Medical Center, both in Boston.
Dr. Makkar said that in the days following the publication of his report, he had “a lot of phone calls and time spent allaying anxiety in patients and reassuring them.”
One reason why these leaflet-motion abnormalities may have shown up on CT examinations recently is that “the cameras have gotten better,” said Dr. Jonathon A. Leipsic, codirector of advanced cardiac imaging at the Providence Health Care Heart Center at St. Paul’s Hospital in Vancouver. Dr. Leipsic also highlighted that with state-of-the-art CT images, immobilized leaflets are easy to identify.
Despite that, Dr. Popma stressed that standardized imaging protocols are needed going forward to produce reliable incidence data.
The data that Dr. Makkar reported came from a review of four-dimensional CT imaging done on 187 replacement aortic valves, usually within 3 months of placement. Images for 55 aortic valves came from the device-approval trial for a new TAVR system, taken 30 days after patients underwent TAVR with any of three types of systems. The images showed reduced leaflet motion in 22 valves (40%).
CT images for another 132 valves came from a Cedar’s-Sinai registry and a second, independent registry maintained in Denmark. CT images showed that 17 (13%) of the replaced aortic valves showed a leaflet-motion abnormality, including two valves placed using SAVR. Half the registry patients had undergone CT imaging within 88 days of valve replacement. The only signal of a clinical outcome linked with reduced-motion leaflets was a small increase in the incidence of transient ischemic attacks, but Dr. Makkar cautioned that transient ischemic attacks “are hard to adjudicate.”
Dr. Makkar’s report was “a small but important study, one of the first reports of this phenomenon. You don’t want to lose sight of all the evidence of patient benefit” from aortic valve replacement, stressed Dr. Kodali at the meeting, sponsored by the Cardiovascular Research Foundation. “This needs to be investigated further, probably by a Food and Drug Administration–mandated trial with CT imaging.”
“Aortic valves are lifesaving devices. The last thing that should happen is patients not getting their aortic valves replaced” when their condition demands it, Dr. Makkar said.
The PORTICO IDE study and RESOLVE registry were funded by St. Jude. Dr. Makkar has received honoraria and research support from St. Jude, lecture fees from Edwards Lifesciences, research grants from Edwards and Medtronic, and has an equity interest in Entourage. Dr. Kodali has been a consultant to Edwards Lifesciences and Claret Medical and has an equity interest in Thubrikar Aortic Valve. Dr. Leon has been a consultant to Edwards. Dr. Popma has been a consultant to Abbott Laboratories, Boston Scientific, and St. Jude, and he has been a speaker for and received grants from Medtronic, Dr. Leipsic has been a consultant to Edwards and Heartflow and received grants from Edwards, Neovasc, and Tendyne.
On Twitter @mitchelzoler
EXPERT ANALYSIS FROM TCT 2015
Key clinical point: CT imaging of recently placed bioprosthetic aortic valves showed several cases of leaflets with reduced motion, suggesting possible clinical consequences.
Major finding: CT imaging showed reduced leaflet motion in 22 of 55 (40%) trial patients and 17 of 132 (13%) registry patients.
Data source: An observational study of CT images collected on 187 patients who had undergone aortic valve replacement from the PORTICO IDE study (55 patients), and the RESOLVE and SAVORY registries (132 total patients).
Disclosures: The PORTICO IDE study and RESOLVE registry were funded by St. Jude. Dr. Makkar has received honoraria and research support from St. Jude, lecture fees from Edwards Lifesciences, research grants from Edwards and Medtronic, and has an equity interest in Entourage.
TCT: FORMA system tested in severe tricuspid regurgitation
The investigational FORMA system seems safe and may be effective in patients with NYHA Class III/IV heart failure and severe tricuspid valve regurgitation, based on 13 first-in-human cases.
A Canadian surgical team employed the FORMA system (Edwards Lifesciences) as compassionate use therapy for a set of patients with inoperable tricuspid regurgitation. The device was successfully deployed in 12 of the 13 patients, according to data presented at the Transcatheter Cardiovascular Therapeutics annual meeting. There were no deaths or major clinical complications in any of the patients.
A report on seven of these patients was simultaneously published in the Journal of the American College of Cardiology. All of the patients had severe tricuspid regurgitation and heart failure; before surgery, six had a New York Heart Association (NYHA) Functional Classification of III/IV. By 30 days after the procedure, all had improved to NYHA II, wrote Dr. Francisco Campelo-Parada of the Quebec Heart and Lung Institute, the paper’s primary author. Peripheral edema declined and all patients experienced functional improvement, as well.
According to Edwards Lifesciences, the FORMA device uses a foam-filled polymer balloon spacer to reduce tricuspid regurgitation by occupying the regurgitant orifice area and providing a surface for the coaptation of the valve’s native leaflets. Implantation is performed via the left axillary vein.
Patients in the series were a mean of 76 years old. All had severe tricuspid regurgitation. The mean maximal vena contracta was 15.5 mm.
Six had coronary artery disease and five had previously undergone open heart surgery. Additionally, two had previously undergone mitral valve surgery and two had undergone aortic valve surgery. Pulmonary hypertension was present in five. Five patients also had persistent atrial fibrillation. Six had renal insufficiency, with one patient on dialysis. The baseline furosemide dose was 80 mg/day.
All procedures were performed under general sedation and fluoroscopic guidance, with postprocedural positioning checked by cardiac-CT and/or a chest x-ray. The mean postop stay was 4 days.
Tricuspid regurgitation was reduced by at least 1 degree in all patients during the operation; four patients had an immediate 2-degree reduction, reclassifying their regurgitation as mild. Two experienced new-onset atrial fibrillation, and one had several episodes of nonsustained ventricular tachycardia that was managed with beta-blockers.
At the first clinical follow-up 30 days after surgery, all but one patient had an improvement to Class II NYHA status.
Two patients were able to reduce their diuretic dosage; there were no other medication changes. Peripheral edema declined in the entire cohort. Tricuspid regurgitation was graded as moderate in all patients.
There were also associated improvements in quality of life, based on scores on the Kansas City Cardiomyopathy Questionnaire, which increased from 59 before surgery to 86 after surgery. Exercise capacity as measured by the 6-Minute Walk Test improved from 297 meters to 326 meters.
The authors suggested that the 15-mm spacer used in the FORMA device was not well-matched with the mean 15.5-mm vena contracta size in the cohort. Better outcomes might be possible if a larger spacer were available.
“Despite good device positioning, complete coaptation was not achieved, resulting in significant residual degree of postprocedural tricuspid regurgitation,” they said. “Also, the very advanced stage of the disease in most patients may have played a role in the mild reduction at 30 days.”
Despite the rather mild, 1-degree improvement, patients did make considerable improvements in heart failure and functional status. Therefore, the team recommended further study for FORMA, with an eye toward optimizing patient selection.
“Specific criteria for quantifying right ventricular dysfunction and pulmonary hypertension, along with novel quantitative echocardiographic imaging criteria may be required,” they said. “It is conceivable that larger than the currently available spacer sizes may be required to improve echocardiographic results in patients with large noncoaptation defects and vena contracta.”
Dr. Campelo-Parada had no financial disclosures with regard to the device.
The investigational FORMA system seems safe and may be effective in patients with NYHA Class III/IV heart failure and severe tricuspid valve regurgitation, based on 13 first-in-human cases.
A Canadian surgical team employed the FORMA system (Edwards Lifesciences) as compassionate use therapy for a set of patients with inoperable tricuspid regurgitation. The device was successfully deployed in 12 of the 13 patients, according to data presented at the Transcatheter Cardiovascular Therapeutics annual meeting. There were no deaths or major clinical complications in any of the patients.
A report on seven of these patients was simultaneously published in the Journal of the American College of Cardiology. All of the patients had severe tricuspid regurgitation and heart failure; before surgery, six had a New York Heart Association (NYHA) Functional Classification of III/IV. By 30 days after the procedure, all had improved to NYHA II, wrote Dr. Francisco Campelo-Parada of the Quebec Heart and Lung Institute, the paper’s primary author. Peripheral edema declined and all patients experienced functional improvement, as well.
According to Edwards Lifesciences, the FORMA device uses a foam-filled polymer balloon spacer to reduce tricuspid regurgitation by occupying the regurgitant orifice area and providing a surface for the coaptation of the valve’s native leaflets. Implantation is performed via the left axillary vein.
Patients in the series were a mean of 76 years old. All had severe tricuspid regurgitation. The mean maximal vena contracta was 15.5 mm.
Six had coronary artery disease and five had previously undergone open heart surgery. Additionally, two had previously undergone mitral valve surgery and two had undergone aortic valve surgery. Pulmonary hypertension was present in five. Five patients also had persistent atrial fibrillation. Six had renal insufficiency, with one patient on dialysis. The baseline furosemide dose was 80 mg/day.
All procedures were performed under general sedation and fluoroscopic guidance, with postprocedural positioning checked by cardiac-CT and/or a chest x-ray. The mean postop stay was 4 days.
Tricuspid regurgitation was reduced by at least 1 degree in all patients during the operation; four patients had an immediate 2-degree reduction, reclassifying their regurgitation as mild. Two experienced new-onset atrial fibrillation, and one had several episodes of nonsustained ventricular tachycardia that was managed with beta-blockers.
At the first clinical follow-up 30 days after surgery, all but one patient had an improvement to Class II NYHA status.
Two patients were able to reduce their diuretic dosage; there were no other medication changes. Peripheral edema declined in the entire cohort. Tricuspid regurgitation was graded as moderate in all patients.
There were also associated improvements in quality of life, based on scores on the Kansas City Cardiomyopathy Questionnaire, which increased from 59 before surgery to 86 after surgery. Exercise capacity as measured by the 6-Minute Walk Test improved from 297 meters to 326 meters.
The authors suggested that the 15-mm spacer used in the FORMA device was not well-matched with the mean 15.5-mm vena contracta size in the cohort. Better outcomes might be possible if a larger spacer were available.
“Despite good device positioning, complete coaptation was not achieved, resulting in significant residual degree of postprocedural tricuspid regurgitation,” they said. “Also, the very advanced stage of the disease in most patients may have played a role in the mild reduction at 30 days.”
Despite the rather mild, 1-degree improvement, patients did make considerable improvements in heart failure and functional status. Therefore, the team recommended further study for FORMA, with an eye toward optimizing patient selection.
“Specific criteria for quantifying right ventricular dysfunction and pulmonary hypertension, along with novel quantitative echocardiographic imaging criteria may be required,” they said. “It is conceivable that larger than the currently available spacer sizes may be required to improve echocardiographic results in patients with large noncoaptation defects and vena contracta.”
Dr. Campelo-Parada had no financial disclosures with regard to the device.
The investigational FORMA system seems safe and may be effective in patients with NYHA Class III/IV heart failure and severe tricuspid valve regurgitation, based on 13 first-in-human cases.
A Canadian surgical team employed the FORMA system (Edwards Lifesciences) as compassionate use therapy for a set of patients with inoperable tricuspid regurgitation. The device was successfully deployed in 12 of the 13 patients, according to data presented at the Transcatheter Cardiovascular Therapeutics annual meeting. There were no deaths or major clinical complications in any of the patients.
A report on seven of these patients was simultaneously published in the Journal of the American College of Cardiology. All of the patients had severe tricuspid regurgitation and heart failure; before surgery, six had a New York Heart Association (NYHA) Functional Classification of III/IV. By 30 days after the procedure, all had improved to NYHA II, wrote Dr. Francisco Campelo-Parada of the Quebec Heart and Lung Institute, the paper’s primary author. Peripheral edema declined and all patients experienced functional improvement, as well.
According to Edwards Lifesciences, the FORMA device uses a foam-filled polymer balloon spacer to reduce tricuspid regurgitation by occupying the regurgitant orifice area and providing a surface for the coaptation of the valve’s native leaflets. Implantation is performed via the left axillary vein.
Patients in the series were a mean of 76 years old. All had severe tricuspid regurgitation. The mean maximal vena contracta was 15.5 mm.
Six had coronary artery disease and five had previously undergone open heart surgery. Additionally, two had previously undergone mitral valve surgery and two had undergone aortic valve surgery. Pulmonary hypertension was present in five. Five patients also had persistent atrial fibrillation. Six had renal insufficiency, with one patient on dialysis. The baseline furosemide dose was 80 mg/day.
All procedures were performed under general sedation and fluoroscopic guidance, with postprocedural positioning checked by cardiac-CT and/or a chest x-ray. The mean postop stay was 4 days.
Tricuspid regurgitation was reduced by at least 1 degree in all patients during the operation; four patients had an immediate 2-degree reduction, reclassifying their regurgitation as mild. Two experienced new-onset atrial fibrillation, and one had several episodes of nonsustained ventricular tachycardia that was managed with beta-blockers.
At the first clinical follow-up 30 days after surgery, all but one patient had an improvement to Class II NYHA status.
Two patients were able to reduce their diuretic dosage; there were no other medication changes. Peripheral edema declined in the entire cohort. Tricuspid regurgitation was graded as moderate in all patients.
There were also associated improvements in quality of life, based on scores on the Kansas City Cardiomyopathy Questionnaire, which increased from 59 before surgery to 86 after surgery. Exercise capacity as measured by the 6-Minute Walk Test improved from 297 meters to 326 meters.
The authors suggested that the 15-mm spacer used in the FORMA device was not well-matched with the mean 15.5-mm vena contracta size in the cohort. Better outcomes might be possible if a larger spacer were available.
“Despite good device positioning, complete coaptation was not achieved, resulting in significant residual degree of postprocedural tricuspid regurgitation,” they said. “Also, the very advanced stage of the disease in most patients may have played a role in the mild reduction at 30 days.”
Despite the rather mild, 1-degree improvement, patients did make considerable improvements in heart failure and functional status. Therefore, the team recommended further study for FORMA, with an eye toward optimizing patient selection.
“Specific criteria for quantifying right ventricular dysfunction and pulmonary hypertension, along with novel quantitative echocardiographic imaging criteria may be required,” they said. “It is conceivable that larger than the currently available spacer sizes may be required to improve echocardiographic results in patients with large noncoaptation defects and vena contracta.”
Dr. Campelo-Parada had no financial disclosures with regard to the device.
FROM TCT 2015
Key clinical point: The investigational FORMA system seems safe and may be effective in patients with NYHA Class III/IV heart failure and severe tricuspid valve regurgitation.
Major finding: The improved heart failure from NYHA Class III/IV to Class II in six of seven patients with severe tricuspid valve regurgitation.
Data source: The device has been used in 13 patients thus far, under compassionate use allowance.
Disclosures: Edwards Lifesciences manufactures and is investigating the device. Dr. Campelo-Parada had no disclosures.
ACS: Hopkins risk score predicts need for early nutrition after cardiac surgery
CHICAGO – A few simple baseline variables predict if heart surgery patients will need early nutritional support after their operations, based on a review of more than 1,000 cardiac surgery patients from Johns Hopkins Hospital in Baltimore.
Nonelective surgery and a cardiopulmonary bypass time of 100 minutes or more, plus five preop variables – previous cardiac interventions; total albumin below 4 g/dL; total bilirubin at or above 1.2 mg/dL; white blood cell counts at or above 11,000/mcL; and hematocrit below 27% – predict the need for nutrition in the first few days after cardiac surgery, they found (J Am Coll Surg. 2015 Oct: 221[4];e70).
The Hopkins team has combined those factors into a risk score, with 4 points assigned for low albumin, 6 points for nonelective surgery, 6 points for low hematocrit, and 5 points for the other four variables, yielding a maximum score of 36 points.
The researchers developed the system after discovering that it sometimes took more than a week for cardiac patients who needed postop nutrition to get it. About 40% of patients with scores of 20 or higher will need early nutritional support, and those heart patients are now the ones at Hopkins who get a nutrition consult as soon as they return from the operating room, said Dr. Rika Ohkuma, a general surgery research fellow at Johns Hopkins. “The score can be used for risk stratification and has potential quality improvement implications related to early initiation of nutritional support in high-risk patients.”
Just 2% of patients who score 10 points or below need early nutrition, so consults are less pressing. About 9% of patients who score from 10-20 points will require nutrition, so consults are at the discretion of the physician, the investigators concluded.
Those insights came from a review of 1,056 adult heart cases in 2012. Just 87 patients (8%) had a postop consult for nutritional support. Most wound up with enteral feedings, but they started an average of 5 days after surgery. The handful that needed both parenteral and enteric feedings started them an average of 7 days after surgery.
Meanwhile, those 87 patients had significantly higher hospital mortality (29% vs. 3%), ventilator time (278 vs. 20 hours), and gastrointestinal complications (32% vs. 5%), and fewer discharges to home (49% vs. 84%) than did other patients.
The team thought that the delay in feeding might have had something to do with the poor outcomes, so “we tried to improve our behavior. We know that nutrition is beneficial for critically ill patients and that we need to start early, but there was no gold standard for when to start,” Dr. Ohkuma said.
The investigators came up with the risk score after figuring out how patients who needed nutrition differed from those who did not. They found, for example, that patients who have emergent surgery were more than three times as likely to have a nutrition consult than were those who had elective procedures.
Now when patients are admitted to the ICU after cardiac surgery, “we all know their [nutrition] score; if they are likely to need support, we immediately call the nutritional support service for a consult.” Patients no longer have to wait, Dr. Ohkuma said.
The researchers launched a prospective study in January 2015. Nutritional needs were addressed sooner, at about postop day 4, for the 70 patients who have needed, and mortality seems to be dropping.
The investigators have no relevant disclosures.
CHICAGO – A few simple baseline variables predict if heart surgery patients will need early nutritional support after their operations, based on a review of more than 1,000 cardiac surgery patients from Johns Hopkins Hospital in Baltimore.
Nonelective surgery and a cardiopulmonary bypass time of 100 minutes or more, plus five preop variables – previous cardiac interventions; total albumin below 4 g/dL; total bilirubin at or above 1.2 mg/dL; white blood cell counts at or above 11,000/mcL; and hematocrit below 27% – predict the need for nutrition in the first few days after cardiac surgery, they found (J Am Coll Surg. 2015 Oct: 221[4];e70).
The Hopkins team has combined those factors into a risk score, with 4 points assigned for low albumin, 6 points for nonelective surgery, 6 points for low hematocrit, and 5 points for the other four variables, yielding a maximum score of 36 points.
The researchers developed the system after discovering that it sometimes took more than a week for cardiac patients who needed postop nutrition to get it. About 40% of patients with scores of 20 or higher will need early nutritional support, and those heart patients are now the ones at Hopkins who get a nutrition consult as soon as they return from the operating room, said Dr. Rika Ohkuma, a general surgery research fellow at Johns Hopkins. “The score can be used for risk stratification and has potential quality improvement implications related to early initiation of nutritional support in high-risk patients.”
Just 2% of patients who score 10 points or below need early nutrition, so consults are less pressing. About 9% of patients who score from 10-20 points will require nutrition, so consults are at the discretion of the physician, the investigators concluded.
Those insights came from a review of 1,056 adult heart cases in 2012. Just 87 patients (8%) had a postop consult for nutritional support. Most wound up with enteral feedings, but they started an average of 5 days after surgery. The handful that needed both parenteral and enteric feedings started them an average of 7 days after surgery.
Meanwhile, those 87 patients had significantly higher hospital mortality (29% vs. 3%), ventilator time (278 vs. 20 hours), and gastrointestinal complications (32% vs. 5%), and fewer discharges to home (49% vs. 84%) than did other patients.
The team thought that the delay in feeding might have had something to do with the poor outcomes, so “we tried to improve our behavior. We know that nutrition is beneficial for critically ill patients and that we need to start early, but there was no gold standard for when to start,” Dr. Ohkuma said.
The investigators came up with the risk score after figuring out how patients who needed nutrition differed from those who did not. They found, for example, that patients who have emergent surgery were more than three times as likely to have a nutrition consult than were those who had elective procedures.
Now when patients are admitted to the ICU after cardiac surgery, “we all know their [nutrition] score; if they are likely to need support, we immediately call the nutritional support service for a consult.” Patients no longer have to wait, Dr. Ohkuma said.
The researchers launched a prospective study in January 2015. Nutritional needs were addressed sooner, at about postop day 4, for the 70 patients who have needed, and mortality seems to be dropping.
The investigators have no relevant disclosures.
CHICAGO – A few simple baseline variables predict if heart surgery patients will need early nutritional support after their operations, based on a review of more than 1,000 cardiac surgery patients from Johns Hopkins Hospital in Baltimore.
Nonelective surgery and a cardiopulmonary bypass time of 100 minutes or more, plus five preop variables – previous cardiac interventions; total albumin below 4 g/dL; total bilirubin at or above 1.2 mg/dL; white blood cell counts at or above 11,000/mcL; and hematocrit below 27% – predict the need for nutrition in the first few days after cardiac surgery, they found (J Am Coll Surg. 2015 Oct: 221[4];e70).
The Hopkins team has combined those factors into a risk score, with 4 points assigned for low albumin, 6 points for nonelective surgery, 6 points for low hematocrit, and 5 points for the other four variables, yielding a maximum score of 36 points.
The researchers developed the system after discovering that it sometimes took more than a week for cardiac patients who needed postop nutrition to get it. About 40% of patients with scores of 20 or higher will need early nutritional support, and those heart patients are now the ones at Hopkins who get a nutrition consult as soon as they return from the operating room, said Dr. Rika Ohkuma, a general surgery research fellow at Johns Hopkins. “The score can be used for risk stratification and has potential quality improvement implications related to early initiation of nutritional support in high-risk patients.”
Just 2% of patients who score 10 points or below need early nutrition, so consults are less pressing. About 9% of patients who score from 10-20 points will require nutrition, so consults are at the discretion of the physician, the investigators concluded.
Those insights came from a review of 1,056 adult heart cases in 2012. Just 87 patients (8%) had a postop consult for nutritional support. Most wound up with enteral feedings, but they started an average of 5 days after surgery. The handful that needed both parenteral and enteric feedings started them an average of 7 days after surgery.
Meanwhile, those 87 patients had significantly higher hospital mortality (29% vs. 3%), ventilator time (278 vs. 20 hours), and gastrointestinal complications (32% vs. 5%), and fewer discharges to home (49% vs. 84%) than did other patients.
The team thought that the delay in feeding might have had something to do with the poor outcomes, so “we tried to improve our behavior. We know that nutrition is beneficial for critically ill patients and that we need to start early, but there was no gold standard for when to start,” Dr. Ohkuma said.
The investigators came up with the risk score after figuring out how patients who needed nutrition differed from those who did not. They found, for example, that patients who have emergent surgery were more than three times as likely to have a nutrition consult than were those who had elective procedures.
Now when patients are admitted to the ICU after cardiac surgery, “we all know their [nutrition] score; if they are likely to need support, we immediately call the nutritional support service for a consult.” Patients no longer have to wait, Dr. Ohkuma said.
The researchers launched a prospective study in January 2015. Nutritional needs were addressed sooner, at about postop day 4, for the 70 patients who have needed, and mortality seems to be dropping.
The investigators have no relevant disclosures.
AT THE AMERICAN COLLEGE OF SURGEONS CLINICAL CONGRESS
Key clinical point: Early evaluation for nutritional needs following heart surgery might prove to reduce morbidity and mortality.
Major finding: In a retrospective study, the 87 patients who received nutritional support an average of 5 or more days after surgery had significantly higher hospital mortality (29% vs. 3%), ventilator time (278 vs. 20 hours), and gastrointestinal complications (32% vs. 5%) than did other post-op patients.
Data source: Review of 1,056 heart surgery patients
Disclosures: The investigators have no relevant disclosures.
ACS: Loop ileostomy may give IBD colitis patients an alternative to urgent colectomy
CHICAGO – Diverting loop ileostomy may be a better option than urgent colectomy as the first surgical step for medically refractory severe ulcerative colitis and Crohn’s disease.
Investigators from the University of California, Los Angeles, have found that ileostomy gives patients a chance to recover from their acute illness – and their colons a chance to heal – so they’re in better shape for definitive surgery further down the road, if it’s even needed (J Am Coll Surg. 2015 Oct;221[4]:S37-S38).
“Urgent colectomy is standard practice for medically refractory severe ulcerative and Crohn’s colitis. However, immunosuppression and malnutrition can result in significant morbidity. This change in management strategy does not eliminate the potential need for definitive surgery, but it does allow for the more extensive procedure to be performed in an elective setting under optimized conditions, thereby improving clinical outcomes,” said the investigators, led by Dr. Amy Lightner, formerly of UCLA but now a colorectal surgery fellow at the Mayo Clinic in Rochester, Minn.
There were just eight patients in the series, so the results are tentative. Six had ulcerative colitis (UC) and two had Crohn’s disease (CD). On presentation, the patients were tachycardic, febrile, malnourished, and anemic, with severe mucosal disease confirmed by endoscopy. Steroids, immunomodulators, and biologics no longer helped. Overall, the patients were too sick to go home, but not quite sick enough for the ICU. Their average age was 29 years.
They underwent a single-incision, laparoscopic diverting loop ileostomy, which took about 45 minutes. The technique, and perhaps the thinking behind it, are similar to one gaining popularity for Clostridium difficile colitis, but without the colonic lavage.
Within 24-48 hours postop, tachycardia and fevers resolved, and patients tolerated oral intake. Narcotic use dropped, and bloody stools became less frequent, and then ceased in all but one patient. Within a month, the average hemoglobin level had climbed from a baseline of 9 g/dL to 11.5 g/dL, and average albumin from 2.5 g/dL to 4 g/dL. Within 2 months, patients’ bowels looked pink and healthy on repeat endoscopy.
“It was a remarkable turnaround. Within 48 hours, they looked markedly different. We are having very good results with this, and it’s much better for patients” than is colectomy during acute illness. “It’s a good change in management,” Dr. Lightner said.
After months of follow-up, two patients, one with UC and one with CD, haven’t needed a colectomy and are maintained on biologics. The other UC patients have had ileal pouch-anal anastomosis. The other CD patient had a subsequent ileorectal anastomosis. Patients were able to undergo those procedures laparoscopically and “have done really well,” Dr. Lightner said.
It’s unclear why loop ileostomy seems so helpful. Perhaps it has something to do with shifts in bacterial populations or decompression of the colon. Maybe it’s just about giving the colon a rest, she said.
The investigators will continue to study the approach. Since the initial report, 8 more patients have joined the series, for a current total of 16. “We are still seeing good results,” Dr. Lightner said.
Dr. Lightner has no disclosures, and there was no outside funding for the work.
These patients are challenging. Often, they are on multiple immunomodulators and are malnourished and anemic, with systemic manifestations of inflammatory disease. The abdomen may be hostile. None of these are favorable factors for doing a total abdominal colectomy, but that remains the standard even today.
This is truly a feasibility or pilot study, and as such, it’s difficult to draw definitive conclusions. Cost-effectiveness is unclear, and some patients are maintained on biologics when, in fact, they may have had a curative procedure with surgery. The follow-up isn’t long enough to look at recurrence of colitis. Nevertheless, it certainly is an intriguing and perhaps revolutionary approach to treating these patients.
Dr. Sean C. Glasgow is a colorectal surgeon and assistant professor of surgery at Washington University in St. Louis. He was not involved with the study.
These patients are challenging. Often, they are on multiple immunomodulators and are malnourished and anemic, with systemic manifestations of inflammatory disease. The abdomen may be hostile. None of these are favorable factors for doing a total abdominal colectomy, but that remains the standard even today.
This is truly a feasibility or pilot study, and as such, it’s difficult to draw definitive conclusions. Cost-effectiveness is unclear, and some patients are maintained on biologics when, in fact, they may have had a curative procedure with surgery. The follow-up isn’t long enough to look at recurrence of colitis. Nevertheless, it certainly is an intriguing and perhaps revolutionary approach to treating these patients.
Dr. Sean C. Glasgow is a colorectal surgeon and assistant professor of surgery at Washington University in St. Louis. He was not involved with the study.
These patients are challenging. Often, they are on multiple immunomodulators and are malnourished and anemic, with systemic manifestations of inflammatory disease. The abdomen may be hostile. None of these are favorable factors for doing a total abdominal colectomy, but that remains the standard even today.
This is truly a feasibility or pilot study, and as such, it’s difficult to draw definitive conclusions. Cost-effectiveness is unclear, and some patients are maintained on biologics when, in fact, they may have had a curative procedure with surgery. The follow-up isn’t long enough to look at recurrence of colitis. Nevertheless, it certainly is an intriguing and perhaps revolutionary approach to treating these patients.
Dr. Sean C. Glasgow is a colorectal surgeon and assistant professor of surgery at Washington University in St. Louis. He was not involved with the study.
CHICAGO – Diverting loop ileostomy may be a better option than urgent colectomy as the first surgical step for medically refractory severe ulcerative colitis and Crohn’s disease.
Investigators from the University of California, Los Angeles, have found that ileostomy gives patients a chance to recover from their acute illness – and their colons a chance to heal – so they’re in better shape for definitive surgery further down the road, if it’s even needed (J Am Coll Surg. 2015 Oct;221[4]:S37-S38).
“Urgent colectomy is standard practice for medically refractory severe ulcerative and Crohn’s colitis. However, immunosuppression and malnutrition can result in significant morbidity. This change in management strategy does not eliminate the potential need for definitive surgery, but it does allow for the more extensive procedure to be performed in an elective setting under optimized conditions, thereby improving clinical outcomes,” said the investigators, led by Dr. Amy Lightner, formerly of UCLA but now a colorectal surgery fellow at the Mayo Clinic in Rochester, Minn.
There were just eight patients in the series, so the results are tentative. Six had ulcerative colitis (UC) and two had Crohn’s disease (CD). On presentation, the patients were tachycardic, febrile, malnourished, and anemic, with severe mucosal disease confirmed by endoscopy. Steroids, immunomodulators, and biologics no longer helped. Overall, the patients were too sick to go home, but not quite sick enough for the ICU. Their average age was 29 years.
They underwent a single-incision, laparoscopic diverting loop ileostomy, which took about 45 minutes. The technique, and perhaps the thinking behind it, are similar to one gaining popularity for Clostridium difficile colitis, but without the colonic lavage.
Within 24-48 hours postop, tachycardia and fevers resolved, and patients tolerated oral intake. Narcotic use dropped, and bloody stools became less frequent, and then ceased in all but one patient. Within a month, the average hemoglobin level had climbed from a baseline of 9 g/dL to 11.5 g/dL, and average albumin from 2.5 g/dL to 4 g/dL. Within 2 months, patients’ bowels looked pink and healthy on repeat endoscopy.
“It was a remarkable turnaround. Within 48 hours, they looked markedly different. We are having very good results with this, and it’s much better for patients” than is colectomy during acute illness. “It’s a good change in management,” Dr. Lightner said.
After months of follow-up, two patients, one with UC and one with CD, haven’t needed a colectomy and are maintained on biologics. The other UC patients have had ileal pouch-anal anastomosis. The other CD patient had a subsequent ileorectal anastomosis. Patients were able to undergo those procedures laparoscopically and “have done really well,” Dr. Lightner said.
It’s unclear why loop ileostomy seems so helpful. Perhaps it has something to do with shifts in bacterial populations or decompression of the colon. Maybe it’s just about giving the colon a rest, she said.
The investigators will continue to study the approach. Since the initial report, 8 more patients have joined the series, for a current total of 16. “We are still seeing good results,” Dr. Lightner said.
Dr. Lightner has no disclosures, and there was no outside funding for the work.
CHICAGO – Diverting loop ileostomy may be a better option than urgent colectomy as the first surgical step for medically refractory severe ulcerative colitis and Crohn’s disease.
Investigators from the University of California, Los Angeles, have found that ileostomy gives patients a chance to recover from their acute illness – and their colons a chance to heal – so they’re in better shape for definitive surgery further down the road, if it’s even needed (J Am Coll Surg. 2015 Oct;221[4]:S37-S38).
“Urgent colectomy is standard practice for medically refractory severe ulcerative and Crohn’s colitis. However, immunosuppression and malnutrition can result in significant morbidity. This change in management strategy does not eliminate the potential need for definitive surgery, but it does allow for the more extensive procedure to be performed in an elective setting under optimized conditions, thereby improving clinical outcomes,” said the investigators, led by Dr. Amy Lightner, formerly of UCLA but now a colorectal surgery fellow at the Mayo Clinic in Rochester, Minn.
There were just eight patients in the series, so the results are tentative. Six had ulcerative colitis (UC) and two had Crohn’s disease (CD). On presentation, the patients were tachycardic, febrile, malnourished, and anemic, with severe mucosal disease confirmed by endoscopy. Steroids, immunomodulators, and biologics no longer helped. Overall, the patients were too sick to go home, but not quite sick enough for the ICU. Their average age was 29 years.
They underwent a single-incision, laparoscopic diverting loop ileostomy, which took about 45 minutes. The technique, and perhaps the thinking behind it, are similar to one gaining popularity for Clostridium difficile colitis, but without the colonic lavage.
Within 24-48 hours postop, tachycardia and fevers resolved, and patients tolerated oral intake. Narcotic use dropped, and bloody stools became less frequent, and then ceased in all but one patient. Within a month, the average hemoglobin level had climbed from a baseline of 9 g/dL to 11.5 g/dL, and average albumin from 2.5 g/dL to 4 g/dL. Within 2 months, patients’ bowels looked pink and healthy on repeat endoscopy.
“It was a remarkable turnaround. Within 48 hours, they looked markedly different. We are having very good results with this, and it’s much better for patients” than is colectomy during acute illness. “It’s a good change in management,” Dr. Lightner said.
After months of follow-up, two patients, one with UC and one with CD, haven’t needed a colectomy and are maintained on biologics. The other UC patients have had ileal pouch-anal anastomosis. The other CD patient had a subsequent ileorectal anastomosis. Patients were able to undergo those procedures laparoscopically and “have done really well,” Dr. Lightner said.
It’s unclear why loop ileostomy seems so helpful. Perhaps it has something to do with shifts in bacterial populations or decompression of the colon. Maybe it’s just about giving the colon a rest, she said.
The investigators will continue to study the approach. Since the initial report, 8 more patients have joined the series, for a current total of 16. “We are still seeing good results,” Dr. Lightner said.
Dr. Lightner has no disclosures, and there was no outside funding for the work.
AT THE ACS CLINICAL CONGRESS
Key clinical point: Patients with refractory inflammatory bowel disease may benefit from loop ileostomy in lieu of urgent colectomy as a first surgical step.
Major finding: Within 24-48 hours after diverting loop ileostomy, tachycardia and fevers resolved, and patients tolerated oral intake. Narcotic use dropped, and bloody stools became less frequent, then ceased.
Data source: Pilot study in eight patients with refractory inflammatory bowel disease
Disclosures: The lead investigator has no disclosures, and there was no outside funding for the work.
ACS: Don’t shy away from venovenous ECMO for trauma lung failure
CHICAGO – Venovenous extracorporeal membrane oxygenation will save perhaps a third of patients who – despite maximum ventilator support – go into end-stage respiratory failure after trauma, according to investigators from the University of Maryland, Baltimore.
“Institutions without the available expertise and ICU capabilities should promptly refer patients with end-stage respiratory failure secondary to trauma to a tertiary care center. Venovenous ECMO [extracorporeal membrane oxygenation] life support may be their only chance for survival and should not be overlooked due to fear of complications,” they concluded.
ECMO usually requires heparin anticoagulation to prevent clots; the fear of subsequent bleeding is one of the things that prevents ECMO’s widespread use in trauma. As a result, “a lot of patients who need ECMO lung support don’t get it,” said Dr. Sarwat Ahmad, of the university.
Dr. Ahmad and her colleagues, however, found that ECMO did not lead to worse outcomes in their lung failure patients.
Their conclusions come from a review of 39 adult blunt and penetrating trauma patients who received ECMO at the university’s Level I trauma center over the past 9 years.
Thirty-two patients had venovenous ECMO mostly for acute respiratory distress; maximal ventilator support, adjunctive medications, and chest therapy did not help. ECMO outflow was from the femoral vein, and blood was returned to the internal jugular vein. Twelve patients (38%) survived, which “is good in this scenario because they otherwise would have died,” Dr. Ahmad said.
The mean pre-ECMO P/F ratio – arterial oxygen partial pressure to fractional inspired oxygen – among the survivors was 98 mm Hg. Values below 100 mm Hg indicate severe lung injury, but some patients had values approaching 200 mm Hg, meaning that ECMO was a good idea even in patients with less severe lung injury.
Seven patients received venoarterial ECMO mostly for cardiac arrest, with outflow from the femoral vein and blood returned via the femoral artery. The patients were pulseless on arrival, so bypassing the heart seemed the only option, but none of them survived. Because of that, the investigators concluded that venoarterial ECMO is “not going to help” in trauma patients, Dr. Ahmad said.
One of the 12 survivors and over half of those who died had injury severity scores above 40 points. Also, Glasgow coma scores below 8 points were far more common among patients who died.
All 12 of the survivors and 14 of the 27 who died were anticoagulated with heparin. “We didn’t see an increased incidence of complications between those who got heparin and those who did not” and, overall, there wasn’t a higher incidence of complications in ECMO patients, compared with other trauma patients. “Even traumatic brain injury patients didn’t do any worse on ECMO. We don’t think that the fear of complications should turn you away from using ECMO,” Dr. Ahmad said.
Dr. Ahmad has no disclosures; there was no external funding for the work.
CHICAGO – Venovenous extracorporeal membrane oxygenation will save perhaps a third of patients who – despite maximum ventilator support – go into end-stage respiratory failure after trauma, according to investigators from the University of Maryland, Baltimore.
“Institutions without the available expertise and ICU capabilities should promptly refer patients with end-stage respiratory failure secondary to trauma to a tertiary care center. Venovenous ECMO [extracorporeal membrane oxygenation] life support may be their only chance for survival and should not be overlooked due to fear of complications,” they concluded.
ECMO usually requires heparin anticoagulation to prevent clots; the fear of subsequent bleeding is one of the things that prevents ECMO’s widespread use in trauma. As a result, “a lot of patients who need ECMO lung support don’t get it,” said Dr. Sarwat Ahmad, of the university.
Dr. Ahmad and her colleagues, however, found that ECMO did not lead to worse outcomes in their lung failure patients.
Their conclusions come from a review of 39 adult blunt and penetrating trauma patients who received ECMO at the university’s Level I trauma center over the past 9 years.
Thirty-two patients had venovenous ECMO mostly for acute respiratory distress; maximal ventilator support, adjunctive medications, and chest therapy did not help. ECMO outflow was from the femoral vein, and blood was returned to the internal jugular vein. Twelve patients (38%) survived, which “is good in this scenario because they otherwise would have died,” Dr. Ahmad said.
The mean pre-ECMO P/F ratio – arterial oxygen partial pressure to fractional inspired oxygen – among the survivors was 98 mm Hg. Values below 100 mm Hg indicate severe lung injury, but some patients had values approaching 200 mm Hg, meaning that ECMO was a good idea even in patients with less severe lung injury.
Seven patients received venoarterial ECMO mostly for cardiac arrest, with outflow from the femoral vein and blood returned via the femoral artery. The patients were pulseless on arrival, so bypassing the heart seemed the only option, but none of them survived. Because of that, the investigators concluded that venoarterial ECMO is “not going to help” in trauma patients, Dr. Ahmad said.
One of the 12 survivors and over half of those who died had injury severity scores above 40 points. Also, Glasgow coma scores below 8 points were far more common among patients who died.
All 12 of the survivors and 14 of the 27 who died were anticoagulated with heparin. “We didn’t see an increased incidence of complications between those who got heparin and those who did not” and, overall, there wasn’t a higher incidence of complications in ECMO patients, compared with other trauma patients. “Even traumatic brain injury patients didn’t do any worse on ECMO. We don’t think that the fear of complications should turn you away from using ECMO,” Dr. Ahmad said.
Dr. Ahmad has no disclosures; there was no external funding for the work.
CHICAGO – Venovenous extracorporeal membrane oxygenation will save perhaps a third of patients who – despite maximum ventilator support – go into end-stage respiratory failure after trauma, according to investigators from the University of Maryland, Baltimore.
“Institutions without the available expertise and ICU capabilities should promptly refer patients with end-stage respiratory failure secondary to trauma to a tertiary care center. Venovenous ECMO [extracorporeal membrane oxygenation] life support may be their only chance for survival and should not be overlooked due to fear of complications,” they concluded.
ECMO usually requires heparin anticoagulation to prevent clots; the fear of subsequent bleeding is one of the things that prevents ECMO’s widespread use in trauma. As a result, “a lot of patients who need ECMO lung support don’t get it,” said Dr. Sarwat Ahmad, of the university.
Dr. Ahmad and her colleagues, however, found that ECMO did not lead to worse outcomes in their lung failure patients.
Their conclusions come from a review of 39 adult blunt and penetrating trauma patients who received ECMO at the university’s Level I trauma center over the past 9 years.
Thirty-two patients had venovenous ECMO mostly for acute respiratory distress; maximal ventilator support, adjunctive medications, and chest therapy did not help. ECMO outflow was from the femoral vein, and blood was returned to the internal jugular vein. Twelve patients (38%) survived, which “is good in this scenario because they otherwise would have died,” Dr. Ahmad said.
The mean pre-ECMO P/F ratio – arterial oxygen partial pressure to fractional inspired oxygen – among the survivors was 98 mm Hg. Values below 100 mm Hg indicate severe lung injury, but some patients had values approaching 200 mm Hg, meaning that ECMO was a good idea even in patients with less severe lung injury.
Seven patients received venoarterial ECMO mostly for cardiac arrest, with outflow from the femoral vein and blood returned via the femoral artery. The patients were pulseless on arrival, so bypassing the heart seemed the only option, but none of them survived. Because of that, the investigators concluded that venoarterial ECMO is “not going to help” in trauma patients, Dr. Ahmad said.
One of the 12 survivors and over half of those who died had injury severity scores above 40 points. Also, Glasgow coma scores below 8 points were far more common among patients who died.
All 12 of the survivors and 14 of the 27 who died were anticoagulated with heparin. “We didn’t see an increased incidence of complications between those who got heparin and those who did not” and, overall, there wasn’t a higher incidence of complications in ECMO patients, compared with other trauma patients. “Even traumatic brain injury patients didn’t do any worse on ECMO. We don’t think that the fear of complications should turn you away from using ECMO,” Dr. Ahmad said.
Dr. Ahmad has no disclosures; there was no external funding for the work.
AT THE ACS CLINICAL CONGRESS
Key clinical point: Venovenous ECMO can be life saving when trauma patients go into respiratory failure.
Major finding: Thirty-two patients had venovenous ECMO, mostly for acute respiratory distress; twelve (38%) survived.
Data source: Review of ECMO in 39 trauma patients
Disclosures: The lead investigator has no disclosures, and there was no external funding for the work.
VIDEO: Identifying preexisting conditions crucial before pneumonectomy, even for benign disease
BOSTON – When performing pneumonectomy on patients with benign disease, it is important to be aware of specific preexisting conditions that could complicate surgery before bringing patients into the operating room.
“Sometimes the usual, standard operative procedure is not appropriate, given the circumstances of a particular patient, [and] typically, these pneumonectomies for benign disease are very challenging operations because the inflamed lung is usually quite densely adherent to the inside of the chest cavity,” explained Dr. G. Alex Patterson of Washington University in St. Louis.
In an interview at the Focus on Thoracic Surgery: Technical Challenges and Complications meeting sponsored by the American Association for Thoracic Surgeons, Dr. Patterson talked about the challenges associated with pneumonectomies for benign disease and how surgeons can safely navigate them.
Dr. Patterson had no relevant disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
BOSTON – When performing pneumonectomy on patients with benign disease, it is important to be aware of specific preexisting conditions that could complicate surgery before bringing patients into the operating room.
“Sometimes the usual, standard operative procedure is not appropriate, given the circumstances of a particular patient, [and] typically, these pneumonectomies for benign disease are very challenging operations because the inflamed lung is usually quite densely adherent to the inside of the chest cavity,” explained Dr. G. Alex Patterson of Washington University in St. Louis.
In an interview at the Focus on Thoracic Surgery: Technical Challenges and Complications meeting sponsored by the American Association for Thoracic Surgeons, Dr. Patterson talked about the challenges associated with pneumonectomies for benign disease and how surgeons can safely navigate them.
Dr. Patterson had no relevant disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
BOSTON – When performing pneumonectomy on patients with benign disease, it is important to be aware of specific preexisting conditions that could complicate surgery before bringing patients into the operating room.
“Sometimes the usual, standard operative procedure is not appropriate, given the circumstances of a particular patient, [and] typically, these pneumonectomies for benign disease are very challenging operations because the inflamed lung is usually quite densely adherent to the inside of the chest cavity,” explained Dr. G. Alex Patterson of Washington University in St. Louis.
In an interview at the Focus on Thoracic Surgery: Technical Challenges and Complications meeting sponsored by the American Association for Thoracic Surgeons, Dr. Patterson talked about the challenges associated with pneumonectomies for benign disease and how surgeons can safely navigate them.
Dr. Patterson had no relevant disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT AATS FOCUS ON THORACIC SURGERY
VIDEO: Complications during thoracoscopic lobectomy are surmountable
BOSTON – When it comes to intraoperative complications during thoracoscopic lobectomy, the mantra for success is to always have a preoperative plan, but be flexible enough to improvise should anything out of the norm arise.
“Many surgeons, when they ask [me] about this specific topic, ask what specific tricks [I] have, but I don’t like to use the word ‘trick’ [because] it’s not something we can do that other people can’t,” explained Dr. Thomas A. D’Amico, chief of general thoracic surgery at Duke University in Durham, North Carolina.
“It’s really just about strategy – how you start an operation, what the conduct of it should be, and when you see things that are less common or more difficult cases, how you think about those and manage those.”
In an interview at the Focus on Thoracic Surgery: Technical Challenges and Complications meeting held by the American Association for Thoracic Surgeons, Dr. D’Amico talked about why surgeons around the world are apprehensive about thoracoscopic lobectomy and why it’s important to begin training residents on how to properly perform the procedure as soon as possible, as it helps mitigate uncertainty while giving them valuable experience to solve any issues that may come up during an operation.
Dr. D’Amico disclosed that he is a consultant for Scanlan, but that it is not relevant to this discussion.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
BOSTON – When it comes to intraoperative complications during thoracoscopic lobectomy, the mantra for success is to always have a preoperative plan, but be flexible enough to improvise should anything out of the norm arise.
“Many surgeons, when they ask [me] about this specific topic, ask what specific tricks [I] have, but I don’t like to use the word ‘trick’ [because] it’s not something we can do that other people can’t,” explained Dr. Thomas A. D’Amico, chief of general thoracic surgery at Duke University in Durham, North Carolina.
“It’s really just about strategy – how you start an operation, what the conduct of it should be, and when you see things that are less common or more difficult cases, how you think about those and manage those.”
In an interview at the Focus on Thoracic Surgery: Technical Challenges and Complications meeting held by the American Association for Thoracic Surgeons, Dr. D’Amico talked about why surgeons around the world are apprehensive about thoracoscopic lobectomy and why it’s important to begin training residents on how to properly perform the procedure as soon as possible, as it helps mitigate uncertainty while giving them valuable experience to solve any issues that may come up during an operation.
Dr. D’Amico disclosed that he is a consultant for Scanlan, but that it is not relevant to this discussion.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
BOSTON – When it comes to intraoperative complications during thoracoscopic lobectomy, the mantra for success is to always have a preoperative plan, but be flexible enough to improvise should anything out of the norm arise.
“Many surgeons, when they ask [me] about this specific topic, ask what specific tricks [I] have, but I don’t like to use the word ‘trick’ [because] it’s not something we can do that other people can’t,” explained Dr. Thomas A. D’Amico, chief of general thoracic surgery at Duke University in Durham, North Carolina.
“It’s really just about strategy – how you start an operation, what the conduct of it should be, and when you see things that are less common or more difficult cases, how you think about those and manage those.”
In an interview at the Focus on Thoracic Surgery: Technical Challenges and Complications meeting held by the American Association for Thoracic Surgeons, Dr. D’Amico talked about why surgeons around the world are apprehensive about thoracoscopic lobectomy and why it’s important to begin training residents on how to properly perform the procedure as soon as possible, as it helps mitigate uncertainty while giving them valuable experience to solve any issues that may come up during an operation.
Dr. D’Amico disclosed that he is a consultant for Scanlan, but that it is not relevant to this discussion.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT AATS FOCUS ON THORACIC SURGERY
Low incidence of DVT reported after percutaneous EVAR
Completely percutaneous endovascular aortic aneurysm repair (PEVAR) has become more common, using the suture-mediated “preclose” technique. The rate of periprocedural, iatrogenic, acute deep vein thrombosis (DVT), hitherto unknown, was found to be low for this approach, according to a study reported by Dr. Courtney E. Morgan and her colleagues at the Northwestern University, Chicago.
The researchers assessed 52 consecutive patients (44 men) with a mean age of 73 years, who underwent PEVAR at their center. Only 6% had a prior history of DVT (J Vasc Surg. 2015 Aug; 62:351-4).
Acute DVT was seen in four patients on postoperative day 1. These four DVTs comprised one femoropopliteal, and three calf DVTs. Three of these patients had associated risk factors: history of DVT (two patients); active smokers (one patient); and obesity (body mass index greater than 30 kg/m2 in all three patients).
At 2 weeks postoperatively, 75% of the DVTs had resolved.
“We found an overall rate of proximal DVT of 4% after PEVAR, which increased to 13% when calf-vein DVTs were included. Most patients with postoperative DVT had preexisting risk factors, which suggests that routine duplex ultrasound screening after PEVAR is not necessary unless there exist preclinical risk factors or postprocedural clinical indications suggestive of DVT,” the authors concluded.
Two of the researchers have received funding and/or served as speakers/consultants for device companies involved in EVAR.
Read the full study online in the Journal of Vascular Surgery.
Completely percutaneous endovascular aortic aneurysm repair (PEVAR) has become more common, using the suture-mediated “preclose” technique. The rate of periprocedural, iatrogenic, acute deep vein thrombosis (DVT), hitherto unknown, was found to be low for this approach, according to a study reported by Dr. Courtney E. Morgan and her colleagues at the Northwestern University, Chicago.
The researchers assessed 52 consecutive patients (44 men) with a mean age of 73 years, who underwent PEVAR at their center. Only 6% had a prior history of DVT (J Vasc Surg. 2015 Aug; 62:351-4).
Acute DVT was seen in four patients on postoperative day 1. These four DVTs comprised one femoropopliteal, and three calf DVTs. Three of these patients had associated risk factors: history of DVT (two patients); active smokers (one patient); and obesity (body mass index greater than 30 kg/m2 in all three patients).
At 2 weeks postoperatively, 75% of the DVTs had resolved.
“We found an overall rate of proximal DVT of 4% after PEVAR, which increased to 13% when calf-vein DVTs were included. Most patients with postoperative DVT had preexisting risk factors, which suggests that routine duplex ultrasound screening after PEVAR is not necessary unless there exist preclinical risk factors or postprocedural clinical indications suggestive of DVT,” the authors concluded.
Two of the researchers have received funding and/or served as speakers/consultants for device companies involved in EVAR.
Read the full study online in the Journal of Vascular Surgery.
Completely percutaneous endovascular aortic aneurysm repair (PEVAR) has become more common, using the suture-mediated “preclose” technique. The rate of periprocedural, iatrogenic, acute deep vein thrombosis (DVT), hitherto unknown, was found to be low for this approach, according to a study reported by Dr. Courtney E. Morgan and her colleagues at the Northwestern University, Chicago.
The researchers assessed 52 consecutive patients (44 men) with a mean age of 73 years, who underwent PEVAR at their center. Only 6% had a prior history of DVT (J Vasc Surg. 2015 Aug; 62:351-4).
Acute DVT was seen in four patients on postoperative day 1. These four DVTs comprised one femoropopliteal, and three calf DVTs. Three of these patients had associated risk factors: history of DVT (two patients); active smokers (one patient); and obesity (body mass index greater than 30 kg/m2 in all three patients).
At 2 weeks postoperatively, 75% of the DVTs had resolved.
“We found an overall rate of proximal DVT of 4% after PEVAR, which increased to 13% when calf-vein DVTs were included. Most patients with postoperative DVT had preexisting risk factors, which suggests that routine duplex ultrasound screening after PEVAR is not necessary unless there exist preclinical risk factors or postprocedural clinical indications suggestive of DVT,” the authors concluded.
Two of the researchers have received funding and/or served as speakers/consultants for device companies involved in EVAR.
Read the full study online in the Journal of Vascular Surgery.
FROM THE JOURNAL OF VASCULAR SURGERY
