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New antiviral combination for HCV infection in kidney disease
The combination of glecaprevir and pibrentasvir has been found to be both safe and effective as a treatment for hepatitis C virus (HCV) infection in patients with end-stage kidney disease, according to a paper published in the New England Journal of Medicine.
There are few treatment options available for these patients, as ribavirin can accumulate systemically in patients with severe renal impairment with serious adverse consequences such as hemolytic anemia and pruritus, and interferon has a negative side-effect profile in this population.
In this open-label phase 3 trial, 104 patients with hepatitis C infection and either compensated liver disease with severe renal impairment, dependence on dialysis, or both received 300 mg glecaprevir and 120 mg pibrentasvir daily for 12 weeks (N Engl J Med. 2017 Oct 12. doi: 10.1056/NEJMoa1704053).
The treatment was associated with a sustained virologic response in 102 patients (98%) at 12 weeks and 100 patients (96%) at 24 weeks, with no cases of virologic failure.
Of the two patients who did not have a sustained virologic response at 12 weeks, one was undergoing hemodialysis at baseline and had both compensated cirrhosis and underlying hypertension, while the other had a history of gastrointestinal tract telangiectasia and discontinued after a nonserious adverse event of diarrhea.
One-quarter of patients experienced serious adverse events, but none were deemed drug related, and there were no reports of liver decompensation. Five patients reported grade 3 hemoglobin abnormalities, but none showed abnormalities in alanine aminotransferase of grade 2 or higher.
The most common adverse events were pruritus, fatigue, and nausea, which were each reported in more than 10% of patients. The authors described this as an acceptable safety profile in a population of patients with numerous coexisting conditions. However, they noted that the absence of a placebo control group made it difficult to compare treatment-related adverse events with the underlying adverse event profile of this group of patients.
“Glecaprevir–pibrentasvir may fulfill an important unmet need; the absence of ribavirin as part of the treatment regimen minimizes the risks of treatment discontinuation and of adverse events due to anemia, which represents a considerable benefit for patients with severe renal insufficiency, since they are at increased risk for life-threatening anemia and cardiac events,” they wrote.
The study was supported by AbbVie. Twelve authors declared speakers bureau, advisory board positions, grants, or other support from AbbVie, as well as grants and funding from other pharmaceutical companies outside this work. Five authors were employees and stockholders of AbbVie.
The combination of glecaprevir and pibrentasvir has been found to be both safe and effective as a treatment for hepatitis C virus (HCV) infection in patients with end-stage kidney disease, according to a paper published in the New England Journal of Medicine.
There are few treatment options available for these patients, as ribavirin can accumulate systemically in patients with severe renal impairment with serious adverse consequences such as hemolytic anemia and pruritus, and interferon has a negative side-effect profile in this population.
In this open-label phase 3 trial, 104 patients with hepatitis C infection and either compensated liver disease with severe renal impairment, dependence on dialysis, or both received 300 mg glecaprevir and 120 mg pibrentasvir daily for 12 weeks (N Engl J Med. 2017 Oct 12. doi: 10.1056/NEJMoa1704053).
The treatment was associated with a sustained virologic response in 102 patients (98%) at 12 weeks and 100 patients (96%) at 24 weeks, with no cases of virologic failure.
Of the two patients who did not have a sustained virologic response at 12 weeks, one was undergoing hemodialysis at baseline and had both compensated cirrhosis and underlying hypertension, while the other had a history of gastrointestinal tract telangiectasia and discontinued after a nonserious adverse event of diarrhea.
One-quarter of patients experienced serious adverse events, but none were deemed drug related, and there were no reports of liver decompensation. Five patients reported grade 3 hemoglobin abnormalities, but none showed abnormalities in alanine aminotransferase of grade 2 or higher.
The most common adverse events were pruritus, fatigue, and nausea, which were each reported in more than 10% of patients. The authors described this as an acceptable safety profile in a population of patients with numerous coexisting conditions. However, they noted that the absence of a placebo control group made it difficult to compare treatment-related adverse events with the underlying adverse event profile of this group of patients.
“Glecaprevir–pibrentasvir may fulfill an important unmet need; the absence of ribavirin as part of the treatment regimen minimizes the risks of treatment discontinuation and of adverse events due to anemia, which represents a considerable benefit for patients with severe renal insufficiency, since they are at increased risk for life-threatening anemia and cardiac events,” they wrote.
The study was supported by AbbVie. Twelve authors declared speakers bureau, advisory board positions, grants, or other support from AbbVie, as well as grants and funding from other pharmaceutical companies outside this work. Five authors were employees and stockholders of AbbVie.
The combination of glecaprevir and pibrentasvir has been found to be both safe and effective as a treatment for hepatitis C virus (HCV) infection in patients with end-stage kidney disease, according to a paper published in the New England Journal of Medicine.
There are few treatment options available for these patients, as ribavirin can accumulate systemically in patients with severe renal impairment with serious adverse consequences such as hemolytic anemia and pruritus, and interferon has a negative side-effect profile in this population.
In this open-label phase 3 trial, 104 patients with hepatitis C infection and either compensated liver disease with severe renal impairment, dependence on dialysis, or both received 300 mg glecaprevir and 120 mg pibrentasvir daily for 12 weeks (N Engl J Med. 2017 Oct 12. doi: 10.1056/NEJMoa1704053).
The treatment was associated with a sustained virologic response in 102 patients (98%) at 12 weeks and 100 patients (96%) at 24 weeks, with no cases of virologic failure.
Of the two patients who did not have a sustained virologic response at 12 weeks, one was undergoing hemodialysis at baseline and had both compensated cirrhosis and underlying hypertension, while the other had a history of gastrointestinal tract telangiectasia and discontinued after a nonserious adverse event of diarrhea.
One-quarter of patients experienced serious adverse events, but none were deemed drug related, and there were no reports of liver decompensation. Five patients reported grade 3 hemoglobin abnormalities, but none showed abnormalities in alanine aminotransferase of grade 2 or higher.
The most common adverse events were pruritus, fatigue, and nausea, which were each reported in more than 10% of patients. The authors described this as an acceptable safety profile in a population of patients with numerous coexisting conditions. However, they noted that the absence of a placebo control group made it difficult to compare treatment-related adverse events with the underlying adverse event profile of this group of patients.
“Glecaprevir–pibrentasvir may fulfill an important unmet need; the absence of ribavirin as part of the treatment regimen minimizes the risks of treatment discontinuation and of adverse events due to anemia, which represents a considerable benefit for patients with severe renal insufficiency, since they are at increased risk for life-threatening anemia and cardiac events,” they wrote.
The study was supported by AbbVie. Twelve authors declared speakers bureau, advisory board positions, grants, or other support from AbbVie, as well as grants and funding from other pharmaceutical companies outside this work. Five authors were employees and stockholders of AbbVie.
FROM NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: The combination of glecaprevir and pibrentasvir has been found to be both safe and effective as a treatment for hepatitis C infection in patients with end-stage kidney disease.
Major finding:
Data source: Open-label phase 3 trial in 104 patients with hepatitis C infection and renal failure.
Disclosures: The study was supported by AbbVie. Twelve authors declared speakers bureau, advisory board positions, grants, or other support from AbbVie, as well as grants and funding from other pharmaceutical companies outside this work. Five authors were employees and stockholders of AbbVie.
PBC linked to low BMD, increased risk of osteoporosis
Patients with primary biliary cholangitis (PBC) have lower lumbar spine and hip bone mineral density (BMD) and are at an increased risk of osteoporosis and fracture, according to Junyu Fan, MD, and associates.
In a meta-analysis of 210 potentially relevant articles, only 8 met the study’s criteria. Of those, five studies were pooled and the overall relationship between PBC and osteoporosis risk was assessed. Results found a significant association between PBC (n = 504) and the prevalence of osteoporosis (P = .01), compared with the control group (n = 2,052).
The study additionally examined possible connection between PBC and bone fractures; more fracture events were reported in PBC patients (n = 929) than in controls (n = 8,699; P less than .00001). It is noted that there was no publication bias (P = .476).
“Further clinical management, follow-up, and surveillance issues should be addressed with caution,” researchers concluded. “Given the limited number of studies included, more high-quality studies will be required to determine the mechanisms underpinning the relationship between PBC and osteoporosis risk.”
Find the full study in Clinical Rheumatology (2017. doi: 10.1007/s10067-017-3844-x).
Patients with primary biliary cholangitis (PBC) have lower lumbar spine and hip bone mineral density (BMD) and are at an increased risk of osteoporosis and fracture, according to Junyu Fan, MD, and associates.
In a meta-analysis of 210 potentially relevant articles, only 8 met the study’s criteria. Of those, five studies were pooled and the overall relationship between PBC and osteoporosis risk was assessed. Results found a significant association between PBC (n = 504) and the prevalence of osteoporosis (P = .01), compared with the control group (n = 2,052).
The study additionally examined possible connection between PBC and bone fractures; more fracture events were reported in PBC patients (n = 929) than in controls (n = 8,699; P less than .00001). It is noted that there was no publication bias (P = .476).
“Further clinical management, follow-up, and surveillance issues should be addressed with caution,” researchers concluded. “Given the limited number of studies included, more high-quality studies will be required to determine the mechanisms underpinning the relationship between PBC and osteoporosis risk.”
Find the full study in Clinical Rheumatology (2017. doi: 10.1007/s10067-017-3844-x).
Patients with primary biliary cholangitis (PBC) have lower lumbar spine and hip bone mineral density (BMD) and are at an increased risk of osteoporosis and fracture, according to Junyu Fan, MD, and associates.
In a meta-analysis of 210 potentially relevant articles, only 8 met the study’s criteria. Of those, five studies were pooled and the overall relationship between PBC and osteoporosis risk was assessed. Results found a significant association between PBC (n = 504) and the prevalence of osteoporosis (P = .01), compared with the control group (n = 2,052).
The study additionally examined possible connection between PBC and bone fractures; more fracture events were reported in PBC patients (n = 929) than in controls (n = 8,699; P less than .00001). It is noted that there was no publication bias (P = .476).
“Further clinical management, follow-up, and surveillance issues should be addressed with caution,” researchers concluded. “Given the limited number of studies included, more high-quality studies will be required to determine the mechanisms underpinning the relationship between PBC and osteoporosis risk.”
Find the full study in Clinical Rheumatology (2017. doi: 10.1007/s10067-017-3844-x).
FROM CLINICAL RHEUMATOLOGY
Minimal residual disease measures not yet impactful for AML patients
SAN FRANCISCO – Routine testing for minimal residual disease is probably not of value in acute myeloid leukemia, as there is no evidence that changing treatment based on MRD status currently makes a difference in patient outcomes, experts said at the annual congress on Hematologic Malignancies held by the National Comprehensive Cancer Network.
“If we find minimal residual disease, we don’t always have a better therapy to offer our patients,” Jessica Altman, MD, associate professor of hematology and oncology at the Northwestern University Feinberg School of Medicine, said.
Beyond that therapeutic reality, there are no clear guidelines and standards for MRD testing. The optimal timing for MRD testing and a standard threshold for an MRD classification are not yet established, she said.
“Having MRD is bad, not having it is better,” Richard Stone, MD, PhD, clinical director of the adult leukemia program at the Dana-Farber Cancer Institute, said. The problem in AML, he said, is, “So?” There is no reliable “MRD eraser” in AML, he said. Until then, there is not much point in knowing whether a patient is MRD positive or not.
A recent survey conducted by researchers at Moffitt Cancer Center, Tampa, addressed MRD testing at 13 major cancer centers. While most centers reported that they test for MRD, many physicians said that they are unsure about what to do with the results.
A 2013 study by the HOVON group found that patients who were in complete remission but MRD positive after their first course of therapy, subsequently became MRD negative after their second course of therapy. But the second regimen would not have been different based on knowledge of MRD status, according to the HOVON/SAKK AML 42A study (J Clin Oncol. 2013; 31:3889-97).
The AML community is awaiting guidelines on MRD use from the NCCN and other groups, Dr. Altman said. An option for using NPM1 mutations to assess MRD should be available soon, and could be an improvement on existing options (N Engl J Med 2016; 374:422-33).
Given the treatment limitations, knowing about MRD status can have a negative mental toll on patients, Dr. Stone said. “I would not underplay the psychological burden.” Nevertheless, MRD should be measured in clinical trials, and it could be a valuable surrogate marker by which to compare drug efficacy.
One of the biggest hopes is that MRD status could eventually be useful in determining the need for allogeneic stem cell transplant in patients deemed intermediate risk, Dr. Altman said. “I think we are finally on the brink of this being actionable.”
Dr. Altman reports financial relationships with Astellas, Bristol-Myers Squibb, Celgene, Janssen, Novartis, and Syros. Dr. Stone reports financial relationships with AbbVie, Actinium, Agios, Amgen and many other companies.
SAN FRANCISCO – Routine testing for minimal residual disease is probably not of value in acute myeloid leukemia, as there is no evidence that changing treatment based on MRD status currently makes a difference in patient outcomes, experts said at the annual congress on Hematologic Malignancies held by the National Comprehensive Cancer Network.
“If we find minimal residual disease, we don’t always have a better therapy to offer our patients,” Jessica Altman, MD, associate professor of hematology and oncology at the Northwestern University Feinberg School of Medicine, said.
Beyond that therapeutic reality, there are no clear guidelines and standards for MRD testing. The optimal timing for MRD testing and a standard threshold for an MRD classification are not yet established, she said.
“Having MRD is bad, not having it is better,” Richard Stone, MD, PhD, clinical director of the adult leukemia program at the Dana-Farber Cancer Institute, said. The problem in AML, he said, is, “So?” There is no reliable “MRD eraser” in AML, he said. Until then, there is not much point in knowing whether a patient is MRD positive or not.
A recent survey conducted by researchers at Moffitt Cancer Center, Tampa, addressed MRD testing at 13 major cancer centers. While most centers reported that they test for MRD, many physicians said that they are unsure about what to do with the results.
A 2013 study by the HOVON group found that patients who were in complete remission but MRD positive after their first course of therapy, subsequently became MRD negative after their second course of therapy. But the second regimen would not have been different based on knowledge of MRD status, according to the HOVON/SAKK AML 42A study (J Clin Oncol. 2013; 31:3889-97).
The AML community is awaiting guidelines on MRD use from the NCCN and other groups, Dr. Altman said. An option for using NPM1 mutations to assess MRD should be available soon, and could be an improvement on existing options (N Engl J Med 2016; 374:422-33).
Given the treatment limitations, knowing about MRD status can have a negative mental toll on patients, Dr. Stone said. “I would not underplay the psychological burden.” Nevertheless, MRD should be measured in clinical trials, and it could be a valuable surrogate marker by which to compare drug efficacy.
One of the biggest hopes is that MRD status could eventually be useful in determining the need for allogeneic stem cell transplant in patients deemed intermediate risk, Dr. Altman said. “I think we are finally on the brink of this being actionable.”
Dr. Altman reports financial relationships with Astellas, Bristol-Myers Squibb, Celgene, Janssen, Novartis, and Syros. Dr. Stone reports financial relationships with AbbVie, Actinium, Agios, Amgen and many other companies.
SAN FRANCISCO – Routine testing for minimal residual disease is probably not of value in acute myeloid leukemia, as there is no evidence that changing treatment based on MRD status currently makes a difference in patient outcomes, experts said at the annual congress on Hematologic Malignancies held by the National Comprehensive Cancer Network.
“If we find minimal residual disease, we don’t always have a better therapy to offer our patients,” Jessica Altman, MD, associate professor of hematology and oncology at the Northwestern University Feinberg School of Medicine, said.
Beyond that therapeutic reality, there are no clear guidelines and standards for MRD testing. The optimal timing for MRD testing and a standard threshold for an MRD classification are not yet established, she said.
“Having MRD is bad, not having it is better,” Richard Stone, MD, PhD, clinical director of the adult leukemia program at the Dana-Farber Cancer Institute, said. The problem in AML, he said, is, “So?” There is no reliable “MRD eraser” in AML, he said. Until then, there is not much point in knowing whether a patient is MRD positive or not.
A recent survey conducted by researchers at Moffitt Cancer Center, Tampa, addressed MRD testing at 13 major cancer centers. While most centers reported that they test for MRD, many physicians said that they are unsure about what to do with the results.
A 2013 study by the HOVON group found that patients who were in complete remission but MRD positive after their first course of therapy, subsequently became MRD negative after their second course of therapy. But the second regimen would not have been different based on knowledge of MRD status, according to the HOVON/SAKK AML 42A study (J Clin Oncol. 2013; 31:3889-97).
The AML community is awaiting guidelines on MRD use from the NCCN and other groups, Dr. Altman said. An option for using NPM1 mutations to assess MRD should be available soon, and could be an improvement on existing options (N Engl J Med 2016; 374:422-33).
Given the treatment limitations, knowing about MRD status can have a negative mental toll on patients, Dr. Stone said. “I would not underplay the psychological burden.” Nevertheless, MRD should be measured in clinical trials, and it could be a valuable surrogate marker by which to compare drug efficacy.
One of the biggest hopes is that MRD status could eventually be useful in determining the need for allogeneic stem cell transplant in patients deemed intermediate risk, Dr. Altman said. “I think we are finally on the brink of this being actionable.”
Dr. Altman reports financial relationships with Astellas, Bristol-Myers Squibb, Celgene, Janssen, Novartis, and Syros. Dr. Stone reports financial relationships with AbbVie, Actinium, Agios, Amgen and many other companies.
EXPERT ANALYSIS AT NCCN HEMATOLOGIC MALIGNANCIES CONGRESS
Venography for stenting led to good results for patients with May-Thurner syndrome
Stenting of the left common iliac vein of patients with May-Thurner syndrome provided good short-term results as compared with nonstenting, according to the results of a retrospective, single-center registry study.
When to treat patients with May-Thurner syndrome (MTS) who have mild symptoms and what degree of compression should trigger intervention are in considerable question. Approximately 50% of the general population has some degree of left common iliac vein (LCIV) compression as detected using intravascular ultrasound (IVUS) and axial imaging, according to Johnathon C. Rollo, MD, of the University of Washington, Seattle, and his colleagues at the University of California, Los Angeles. They performed their study in order to address the debate over what were the optimal IVUS and venography criteria for stent implantation in these patients.
Of 102 patients in a registry, 63 had clear evidence of LCIV compression by the overlying right common iliac artery by IVUS assessment or venography. Nonthrombotic MTS patients who presented with chronic leg swelling or venous claudication underwent duplex ultrasound to rule out deep-vein thrombosis (DVT) were placed in compression therapy, and venography was performed to assess for iliac vein involvement
Iliac vein stenting was offered to those patients who met the following criteria:
• Sufficiently severe symptoms of swelling, venous claudication, or pain to affect their quality of life despite compression therapy.
• Diagnostic venogram imaging showing evidence of physiologically significant MTS compression, including contrast stagnation within the proximal left common and external iliac vein, contralateral cross-filling to the right iliac venous • circulation via hypogastric collateral networks, and/or significant retroperitoneal collateralization.
• IVUS assessment demonstrating greater than 50% luminal narrowing of the LCIV or extensive intravascular webs.
Patients who did not meet one of these criteria (generally the venogram findings) were treated with continued conservative management, which consisted of compression therapy, weight loss and exercise programs, and other conservative measures (J Vasc Surg: Venous Lymphatic Disorders. 2017;5:667-76).
Of the 63 patients in the final study group, a total of 44 were treated with iliofemoral stents, with or without thrombolysis, and 19 conservatively managed patients who were not treated with stents served as controls. The mean age of the patients was 46 years, and 76% of them were women. With regard to comorbidities, 63% had a patient-reported history of DVT, and 22% had a patient-reported history of pulmonary embolism. Of the 63 patients, 32 had nonthrombotic MTS.
Stent diameter was based on IVUS measurement, with the goal of achieving normal vein diameter, and undersizing was avoided. Stenting was performed under local anesthesia.
A total of 44 patients (70%) underwent primary stenting (70%) or thrombolysis and stenting (30%), whereas 19 patients were not stented. Of these latter, 14 were nonthrombotic and were treated conservatively with compression therapy alone; the remaining 5 patients with thrombotic MTS were treated with lysis or angioplasty alone. Technical success was achieved in 100% of patients who had an intervention.
Primary and secondary patency rates in the stented thrombotic population were 87% and 93% at 24 months, respectively, by Kaplan-Meier analysis and were not significantly different from the results of the nonthrombotic stented patients.
Clinical improvement was significantly more likely in stented patients, compared with those managed without stenting (95% vs. 58%, respectively; P less than .001), Complete clinical resolution, defined as an absence of swelling or any other venous symptoms, was three times more likely in stented patients than in nonstented patients (64% vs. 21%, respectively; P less than .001), according to the researchers.
“MTS patients are typically young and relatively healthy. Whereas several series have demonstrated good intermediate-term results out to 7-10 years, the durability of these stents 20-30 years or more after implantation is unknown. For this reason, our group has been conservative in offering stent implantation to nonthrombotic patients,” Dr. Rollo and his colleagues stated.
“Regardless of the differential in clinical outcomes between stented and nonstented patients, this selective approach to stenting is reasonable in that those believed to be best managed with conservative therapy can be re-evaluated at regular intervals for clinical deterioration,” they concluded.
The authors reported that they had no disclosures.
Most vascular specialists, including our group in New York, have relied heavily on intravascular ultrasound demonstrating greater than 50% stenosis to decide whether or not stenting is indicated. Dr. Rollo and his associates emphasized the importance of using venography-guided findings (contrast stagnation within the external iliac vein, contralateral cross-filling to the right iliac system, and/or significant retroperitoneal collateralization) to decide on stent indication. They did, however, use IVUS to guide in stent sizing and placement.
Todd Berland, MD , is the director, outpatient vascular interventions, NYU Langone Health, New York, N.Y. He had no relevant financial disclosures.
Most vascular specialists, including our group in New York, have relied heavily on intravascular ultrasound demonstrating greater than 50% stenosis to decide whether or not stenting is indicated. Dr. Rollo and his associates emphasized the importance of using venography-guided findings (contrast stagnation within the external iliac vein, contralateral cross-filling to the right iliac system, and/or significant retroperitoneal collateralization) to decide on stent indication. They did, however, use IVUS to guide in stent sizing and placement.
Todd Berland, MD , is the director, outpatient vascular interventions, NYU Langone Health, New York, N.Y. He had no relevant financial disclosures.
Most vascular specialists, including our group in New York, have relied heavily on intravascular ultrasound demonstrating greater than 50% stenosis to decide whether or not stenting is indicated. Dr. Rollo and his associates emphasized the importance of using venography-guided findings (contrast stagnation within the external iliac vein, contralateral cross-filling to the right iliac system, and/or significant retroperitoneal collateralization) to decide on stent indication. They did, however, use IVUS to guide in stent sizing and placement.
Todd Berland, MD , is the director, outpatient vascular interventions, NYU Langone Health, New York, N.Y. He had no relevant financial disclosures.
Stenting of the left common iliac vein of patients with May-Thurner syndrome provided good short-term results as compared with nonstenting, according to the results of a retrospective, single-center registry study.
When to treat patients with May-Thurner syndrome (MTS) who have mild symptoms and what degree of compression should trigger intervention are in considerable question. Approximately 50% of the general population has some degree of left common iliac vein (LCIV) compression as detected using intravascular ultrasound (IVUS) and axial imaging, according to Johnathon C. Rollo, MD, of the University of Washington, Seattle, and his colleagues at the University of California, Los Angeles. They performed their study in order to address the debate over what were the optimal IVUS and venography criteria for stent implantation in these patients.
Of 102 patients in a registry, 63 had clear evidence of LCIV compression by the overlying right common iliac artery by IVUS assessment or venography. Nonthrombotic MTS patients who presented with chronic leg swelling or venous claudication underwent duplex ultrasound to rule out deep-vein thrombosis (DVT) were placed in compression therapy, and venography was performed to assess for iliac vein involvement
Iliac vein stenting was offered to those patients who met the following criteria:
• Sufficiently severe symptoms of swelling, venous claudication, or pain to affect their quality of life despite compression therapy.
• Diagnostic venogram imaging showing evidence of physiologically significant MTS compression, including contrast stagnation within the proximal left common and external iliac vein, contralateral cross-filling to the right iliac venous • circulation via hypogastric collateral networks, and/or significant retroperitoneal collateralization.
• IVUS assessment demonstrating greater than 50% luminal narrowing of the LCIV or extensive intravascular webs.
Patients who did not meet one of these criteria (generally the venogram findings) were treated with continued conservative management, which consisted of compression therapy, weight loss and exercise programs, and other conservative measures (J Vasc Surg: Venous Lymphatic Disorders. 2017;5:667-76).
Of the 63 patients in the final study group, a total of 44 were treated with iliofemoral stents, with or without thrombolysis, and 19 conservatively managed patients who were not treated with stents served as controls. The mean age of the patients was 46 years, and 76% of them were women. With regard to comorbidities, 63% had a patient-reported history of DVT, and 22% had a patient-reported history of pulmonary embolism. Of the 63 patients, 32 had nonthrombotic MTS.
Stent diameter was based on IVUS measurement, with the goal of achieving normal vein diameter, and undersizing was avoided. Stenting was performed under local anesthesia.
A total of 44 patients (70%) underwent primary stenting (70%) or thrombolysis and stenting (30%), whereas 19 patients were not stented. Of these latter, 14 were nonthrombotic and were treated conservatively with compression therapy alone; the remaining 5 patients with thrombotic MTS were treated with lysis or angioplasty alone. Technical success was achieved in 100% of patients who had an intervention.
Primary and secondary patency rates in the stented thrombotic population were 87% and 93% at 24 months, respectively, by Kaplan-Meier analysis and were not significantly different from the results of the nonthrombotic stented patients.
Clinical improvement was significantly more likely in stented patients, compared with those managed without stenting (95% vs. 58%, respectively; P less than .001), Complete clinical resolution, defined as an absence of swelling or any other venous symptoms, was three times more likely in stented patients than in nonstented patients (64% vs. 21%, respectively; P less than .001), according to the researchers.
“MTS patients are typically young and relatively healthy. Whereas several series have demonstrated good intermediate-term results out to 7-10 years, the durability of these stents 20-30 years or more after implantation is unknown. For this reason, our group has been conservative in offering stent implantation to nonthrombotic patients,” Dr. Rollo and his colleagues stated.
“Regardless of the differential in clinical outcomes between stented and nonstented patients, this selective approach to stenting is reasonable in that those believed to be best managed with conservative therapy can be re-evaluated at regular intervals for clinical deterioration,” they concluded.
The authors reported that they had no disclosures.
Stenting of the left common iliac vein of patients with May-Thurner syndrome provided good short-term results as compared with nonstenting, according to the results of a retrospective, single-center registry study.
When to treat patients with May-Thurner syndrome (MTS) who have mild symptoms and what degree of compression should trigger intervention are in considerable question. Approximately 50% of the general population has some degree of left common iliac vein (LCIV) compression as detected using intravascular ultrasound (IVUS) and axial imaging, according to Johnathon C. Rollo, MD, of the University of Washington, Seattle, and his colleagues at the University of California, Los Angeles. They performed their study in order to address the debate over what were the optimal IVUS and venography criteria for stent implantation in these patients.
Of 102 patients in a registry, 63 had clear evidence of LCIV compression by the overlying right common iliac artery by IVUS assessment or venography. Nonthrombotic MTS patients who presented with chronic leg swelling or venous claudication underwent duplex ultrasound to rule out deep-vein thrombosis (DVT) were placed in compression therapy, and venography was performed to assess for iliac vein involvement
Iliac vein stenting was offered to those patients who met the following criteria:
• Sufficiently severe symptoms of swelling, venous claudication, or pain to affect their quality of life despite compression therapy.
• Diagnostic venogram imaging showing evidence of physiologically significant MTS compression, including contrast stagnation within the proximal left common and external iliac vein, contralateral cross-filling to the right iliac venous • circulation via hypogastric collateral networks, and/or significant retroperitoneal collateralization.
• IVUS assessment demonstrating greater than 50% luminal narrowing of the LCIV or extensive intravascular webs.
Patients who did not meet one of these criteria (generally the venogram findings) were treated with continued conservative management, which consisted of compression therapy, weight loss and exercise programs, and other conservative measures (J Vasc Surg: Venous Lymphatic Disorders. 2017;5:667-76).
Of the 63 patients in the final study group, a total of 44 were treated with iliofemoral stents, with or without thrombolysis, and 19 conservatively managed patients who were not treated with stents served as controls. The mean age of the patients was 46 years, and 76% of them were women. With regard to comorbidities, 63% had a patient-reported history of DVT, and 22% had a patient-reported history of pulmonary embolism. Of the 63 patients, 32 had nonthrombotic MTS.
Stent diameter was based on IVUS measurement, with the goal of achieving normal vein diameter, and undersizing was avoided. Stenting was performed under local anesthesia.
A total of 44 patients (70%) underwent primary stenting (70%) or thrombolysis and stenting (30%), whereas 19 patients were not stented. Of these latter, 14 were nonthrombotic and were treated conservatively with compression therapy alone; the remaining 5 patients with thrombotic MTS were treated with lysis or angioplasty alone. Technical success was achieved in 100% of patients who had an intervention.
Primary and secondary patency rates in the stented thrombotic population were 87% and 93% at 24 months, respectively, by Kaplan-Meier analysis and were not significantly different from the results of the nonthrombotic stented patients.
Clinical improvement was significantly more likely in stented patients, compared with those managed without stenting (95% vs. 58%, respectively; P less than .001), Complete clinical resolution, defined as an absence of swelling or any other venous symptoms, was three times more likely in stented patients than in nonstented patients (64% vs. 21%, respectively; P less than .001), according to the researchers.
“MTS patients are typically young and relatively healthy. Whereas several series have demonstrated good intermediate-term results out to 7-10 years, the durability of these stents 20-30 years or more after implantation is unknown. For this reason, our group has been conservative in offering stent implantation to nonthrombotic patients,” Dr. Rollo and his colleagues stated.
“Regardless of the differential in clinical outcomes between stented and nonstented patients, this selective approach to stenting is reasonable in that those believed to be best managed with conservative therapy can be re-evaluated at regular intervals for clinical deterioration,” they concluded.
The authors reported that they had no disclosures.
FROM THE JOURNAL OF VASCULAR SURGERY: VENOUS AND LYMPHATIC DISORDERS
Key clinical point:
Major finding: May-Thurner patients treated with iliofemoral stents had significantly better (95%) clinical improvement than 21 patients not treated with stents (58%).
Data source: Retrospective analysis of a single-center registry of 65 patients with May-Thurner syndrome.
Disclosures: The authors reported that they had no disclosures.
Adaptive pneumatic compression device found comparable to compression stockings
The use of an adaptive pneumatic compression device showed comparable results to compression stockings in a two-arm, randomized multicenter pilot study of previously noncompliant patients with chronic venous disease.
In addition, patient satisfaction regarding ease of use was higher in for the device, compared with the stockings, according to Fedor Lurie, MD, PhD, of the Jobst Vascular Institute, Toledo, Ohio, and his colleague.
A total of 89 subjects with unilateral or bilateral chronic venous insufficiency were randomized and included in the final analysis of the study. The patients comprised 44% women, with a median age of nearly 63 years, the majority (53%) of whom had bilateral chronic venous insufficiency (J Vasc Surg Venous Lymphat Disord. 2017 Sep;5[5]:699-706).
Significantly more patients found the ACTitouch device easy to apply (71%) versus the compression stockings (37.5%; P = .0001) and easy to remove (89% vs. 59%; P = .0001). However, compliance and average time of use were not significantly different between the two treatment groups.
In terms of limb volume reduction, the device group demonstrated a significant volume reduction (44%), compared with the standard compression garment use (17%) in obese patients (P = .019) but not in nonobese patients.
The device was easy to put on and remove and was considered comfortable, according to the researchers. “These are characteristics usually associated with good potential for long-term acceptance by patients. The observed trend that suggested an associated benefit in achieving limb volume reduction (magnified in obese patients) was greater with the AT device than with [compression stockings],” the researchers concluded.
Tactile Medical, which manufactures the device, was the study sponsor and provided funding for the study costs. The authors received no specific funding for their work.
The use of an adaptive pneumatic compression device showed comparable results to compression stockings in a two-arm, randomized multicenter pilot study of previously noncompliant patients with chronic venous disease.
In addition, patient satisfaction regarding ease of use was higher in for the device, compared with the stockings, according to Fedor Lurie, MD, PhD, of the Jobst Vascular Institute, Toledo, Ohio, and his colleague.
A total of 89 subjects with unilateral or bilateral chronic venous insufficiency were randomized and included in the final analysis of the study. The patients comprised 44% women, with a median age of nearly 63 years, the majority (53%) of whom had bilateral chronic venous insufficiency (J Vasc Surg Venous Lymphat Disord. 2017 Sep;5[5]:699-706).
Significantly more patients found the ACTitouch device easy to apply (71%) versus the compression stockings (37.5%; P = .0001) and easy to remove (89% vs. 59%; P = .0001). However, compliance and average time of use were not significantly different between the two treatment groups.
In terms of limb volume reduction, the device group demonstrated a significant volume reduction (44%), compared with the standard compression garment use (17%) in obese patients (P = .019) but not in nonobese patients.
The device was easy to put on and remove and was considered comfortable, according to the researchers. “These are characteristics usually associated with good potential for long-term acceptance by patients. The observed trend that suggested an associated benefit in achieving limb volume reduction (magnified in obese patients) was greater with the AT device than with [compression stockings],” the researchers concluded.
Tactile Medical, which manufactures the device, was the study sponsor and provided funding for the study costs. The authors received no specific funding for their work.
The use of an adaptive pneumatic compression device showed comparable results to compression stockings in a two-arm, randomized multicenter pilot study of previously noncompliant patients with chronic venous disease.
In addition, patient satisfaction regarding ease of use was higher in for the device, compared with the stockings, according to Fedor Lurie, MD, PhD, of the Jobst Vascular Institute, Toledo, Ohio, and his colleague.
A total of 89 subjects with unilateral or bilateral chronic venous insufficiency were randomized and included in the final analysis of the study. The patients comprised 44% women, with a median age of nearly 63 years, the majority (53%) of whom had bilateral chronic venous insufficiency (J Vasc Surg Venous Lymphat Disord. 2017 Sep;5[5]:699-706).
Significantly more patients found the ACTitouch device easy to apply (71%) versus the compression stockings (37.5%; P = .0001) and easy to remove (89% vs. 59%; P = .0001). However, compliance and average time of use were not significantly different between the two treatment groups.
In terms of limb volume reduction, the device group demonstrated a significant volume reduction (44%), compared with the standard compression garment use (17%) in obese patients (P = .019) but not in nonobese patients.
The device was easy to put on and remove and was considered comfortable, according to the researchers. “These are characteristics usually associated with good potential for long-term acceptance by patients. The observed trend that suggested an associated benefit in achieving limb volume reduction (magnified in obese patients) was greater with the AT device than with [compression stockings],” the researchers concluded.
Tactile Medical, which manufactures the device, was the study sponsor and provided funding for the study costs. The authors received no specific funding for their work.
FROM THE JOURNAL OF VASCULAR SURGERY: VENOUS AND LYMPHATIC DISORDERS
Vascular surgery trainees perceive weakness in venous education, case volumes
Venous training during vascular residency programs is perceived to be lacking in both case volume and didactic education, based on the results of a national survey of vascular trainees.
The majority of respondents (82%) believed that treating venous disease is part of a standard vascular practice, and 75% indicated a desire for increased venous training, according to article in press published online in the Journal of Vascular Surgery: Venous and Lymphatic Disorders.
In terms of case loads, the responders reported the following:
- 63% had performed fewer than 10 inferior vena cava stents.
- 64% had performed fewer than 10 vein stripping/ligation procedures.
- 50% had performed fewer than 10 iliac stents.
- 92% had performed fewer than 10 venous bypasses.
In contrast, 74% of responders reported having performed as many as 20 cases of endothermal ablation.
Currently, the Accreditation Council for Graduate Medical Education does not demand a minimum number of venous cases before graduation from a vascular training program, Dr. Hicks and her colleagues wrote.
Although integrated and traditional vascular surgery trainees showed no overall differences in reported venous procedure volumes (P less than or equal to .28), integrated students reported receiving significantly more didactic education than their traditionally trained peers (P less than or equal to .01).
Both integrated and traditional vascular surgery trainees recognized a need for a more comprehensive educational curriculum in venous disease in terms of both didactic education and case exposure, the authors reported.
“Our data suggest that expansion of the venous training curriculum with clear training standards is warranted and that trainees would welcome such a change,” wrote Dr. Hicks and her colleagues.
“Further study will be required to determine if the perceived deficits affect recent graduates’ experiences with venous disease in their developing practice and if increasing training in venous disease during vascular residency will increase the venous work performed by practicing vascular surgeons,” they concluded.
The authors reported that they had no conflicts of interest.
Venous training during vascular residency programs is perceived to be lacking in both case volume and didactic education, based on the results of a national survey of vascular trainees.
The majority of respondents (82%) believed that treating venous disease is part of a standard vascular practice, and 75% indicated a desire for increased venous training, according to article in press published online in the Journal of Vascular Surgery: Venous and Lymphatic Disorders.
In terms of case loads, the responders reported the following:
- 63% had performed fewer than 10 inferior vena cava stents.
- 64% had performed fewer than 10 vein stripping/ligation procedures.
- 50% had performed fewer than 10 iliac stents.
- 92% had performed fewer than 10 venous bypasses.
In contrast, 74% of responders reported having performed as many as 20 cases of endothermal ablation.
Currently, the Accreditation Council for Graduate Medical Education does not demand a minimum number of venous cases before graduation from a vascular training program, Dr. Hicks and her colleagues wrote.
Although integrated and traditional vascular surgery trainees showed no overall differences in reported venous procedure volumes (P less than or equal to .28), integrated students reported receiving significantly more didactic education than their traditionally trained peers (P less than or equal to .01).
Both integrated and traditional vascular surgery trainees recognized a need for a more comprehensive educational curriculum in venous disease in terms of both didactic education and case exposure, the authors reported.
“Our data suggest that expansion of the venous training curriculum with clear training standards is warranted and that trainees would welcome such a change,” wrote Dr. Hicks and her colleagues.
“Further study will be required to determine if the perceived deficits affect recent graduates’ experiences with venous disease in their developing practice and if increasing training in venous disease during vascular residency will increase the venous work performed by practicing vascular surgeons,” they concluded.
The authors reported that they had no conflicts of interest.
Venous training during vascular residency programs is perceived to be lacking in both case volume and didactic education, based on the results of a national survey of vascular trainees.
The majority of respondents (82%) believed that treating venous disease is part of a standard vascular practice, and 75% indicated a desire for increased venous training, according to article in press published online in the Journal of Vascular Surgery: Venous and Lymphatic Disorders.
In terms of case loads, the responders reported the following:
- 63% had performed fewer than 10 inferior vena cava stents.
- 64% had performed fewer than 10 vein stripping/ligation procedures.
- 50% had performed fewer than 10 iliac stents.
- 92% had performed fewer than 10 venous bypasses.
In contrast, 74% of responders reported having performed as many as 20 cases of endothermal ablation.
Currently, the Accreditation Council for Graduate Medical Education does not demand a minimum number of venous cases before graduation from a vascular training program, Dr. Hicks and her colleagues wrote.
Although integrated and traditional vascular surgery trainees showed no overall differences in reported venous procedure volumes (P less than or equal to .28), integrated students reported receiving significantly more didactic education than their traditionally trained peers (P less than or equal to .01).
Both integrated and traditional vascular surgery trainees recognized a need for a more comprehensive educational curriculum in venous disease in terms of both didactic education and case exposure, the authors reported.
“Our data suggest that expansion of the venous training curriculum with clear training standards is warranted and that trainees would welcome such a change,” wrote Dr. Hicks and her colleagues.
“Further study will be required to determine if the perceived deficits affect recent graduates’ experiences with venous disease in their developing practice and if increasing training in venous disease during vascular residency will increase the venous work performed by practicing vascular surgeons,” they concluded.
The authors reported that they had no conflicts of interest.
FROM THE JOURNAL OF VASCULAR SURGERY: VENOUS AND LYMPHATIC DISORDERS
Key clinical point:
Major finding: Of the of vascular trainees who responded to the survey, 75% reported a desire for increased venous training.
Data source: Nationwide U.S. survey of vascular trainees resulting in a 104/464 (22%) response rate.
Disclosures: The authors reported having no conflicts of interest.
Watch for our breaking news coverage
GI & Hepatology News will be in Orlando next week at the Orange County Convention Center reporting the latest news from the World Congress of Gastroenterology at ACG 2017. Studies slated for presentation will detail new findings in every area of clinical concern to the gastroenterologist.
Our onsite reporters will cover new drugs and treatment regimens in inflammatory bowel disease, endoscopic advances for treatment along the GI tract, and novel tests and biomarkers for various disease states.
Highly anticipated presentations include:
- Risk of metachronous high-risk adenomas and large (greater than or equal to 1 cm) serrated polyps in individuals with serrated polyps on index colonoscopy: Longitudinal data from the New Hampshire Colonoscopy Registry.
- Enhanced recovery in acute pancreatitis (RAPTor): A randomized controlled trial.
- A prospective validation of deep learning for polyp autodetection during colonoscopy.
GI & Hepatology News will be in Orlando next week at the Orange County Convention Center reporting the latest news from the World Congress of Gastroenterology at ACG 2017. Studies slated for presentation will detail new findings in every area of clinical concern to the gastroenterologist.
Our onsite reporters will cover new drugs and treatment regimens in inflammatory bowel disease, endoscopic advances for treatment along the GI tract, and novel tests and biomarkers for various disease states.
Highly anticipated presentations include:
- Risk of metachronous high-risk adenomas and large (greater than or equal to 1 cm) serrated polyps in individuals with serrated polyps on index colonoscopy: Longitudinal data from the New Hampshire Colonoscopy Registry.
- Enhanced recovery in acute pancreatitis (RAPTor): A randomized controlled trial.
- A prospective validation of deep learning for polyp autodetection during colonoscopy.
GI & Hepatology News will be in Orlando next week at the Orange County Convention Center reporting the latest news from the World Congress of Gastroenterology at ACG 2017. Studies slated for presentation will detail new findings in every area of clinical concern to the gastroenterologist.
Our onsite reporters will cover new drugs and treatment regimens in inflammatory bowel disease, endoscopic advances for treatment along the GI tract, and novel tests and biomarkers for various disease states.
Highly anticipated presentations include:
- Risk of metachronous high-risk adenomas and large (greater than or equal to 1 cm) serrated polyps in individuals with serrated polyps on index colonoscopy: Longitudinal data from the New Hampshire Colonoscopy Registry.
- Enhanced recovery in acute pancreatitis (RAPTor): A randomized controlled trial.
- A prospective validation of deep learning for polyp autodetection during colonoscopy.
Phrenic nerve stimulator shows heart failure benefits
DALLAS– Heart failure patients with central sleep apnea who received treatment with a transvenous phrenic nerve–stimulating device showed dramatic improvement in their global self-assessment, compared with control patients, in a subgroup analysis of 80 patients enrolled in the device’s pivotal trial.
Among 35 patients with heart failure enrolled in the remedē System pivotal trial and treated for 6 months with phrenic nerve stimulation, 57% reported that they had “markedly” or “moderately” improved, compared with a 9% rate for this self-rating among 44 control heart failure patients in the trial, a statistically significant difference, Lee R. Goldberg, MD, said at the annual scientific meeting of the Heart Failure Society of America.
Further analysis focused on echocardiographic examinations after 12 months in 23 of the heart failure patients who entered the study with a left ventricular ejection fraction of 45% or less and received 12 months of phrenic nerve stimulation. The average LVEF rose in these patients from 30% at baseline to 35%, a statistically significant difference, and left ventricular end systolic volume fell by an average of almost 11 mL from baseline, a difference just short of statistical significance, findings Dr. Goldberg called “a little exciting.”
“It is very encouraging to see some evidence for ventricular remodeling,” commented Lynne W. Stevenson, MD, professor of medicine and a heart failure specialist at Vanderbilt University in Nashville, Tenn.
The FDA approved the use of this device for the treatment of moderate to severe central sleep apnea on Oct. 6. “I think we would use it” in heart failure patients with intolerable symptoms from central sleep apnea, Dr. Goldberg said in an interview during the meeting.
“There is a tight connection between sleep-disordered breathing, sleep apnea, heart failure, and cardiovascular disease, and we have been pretty aggressive in trying to treat the sleep apnea. Even if phrenic nerve stimulation just improves patients’ quality of life and is neutral for other outcomes,” it would be reasonable to offer it to patients, he said. “But many of us think there is a bigger connection that results in a therapeutic benefit [to heart failure patients] by treating their central sleep apnea.”
The pivotal trial enrolled a total of 151 patients with central sleep apnea at 31 centers in Germany, Poland, and the United States who were selected based on having an apnea-hypopnea index of at least 20 events per hour. All participants received a transvenous phrenic nerve–stimulator implant, and then randomization assigned 73 patients to have the device turned on for the first 6 months while 78 device recipients had their devices left off to serve as controls. The study’s primary efficacy endpoint was the percentage of patients having at least a 50% cut in their apnea-hypopnea index, which happened in 51% of evaluable patients in the active treatment arm and in 11% of the evaluable controls. The primary results were published last year (Lancet. 2016 Sep 3;388[10048]974-82).
“We hope this treatment will have the collateral effect of improving cardiovascular disease outcomes, but we don’t know that yet. The initial target will be patients with apnea-hypopnea episodes that affect their quality of life,” Dr. Goldberg said.
The apparent safety of this approach for treating central sleep apnea may relate to its mechanism of action, he suggested. The mortality-boosting effect of adaptive servo-ventilation may correlate with the positive pressure it creates in a patient’s chest that perhaps causes myocardial stress or hemodynamic problems. In contrast, phrenic nerve stimulation produces diaphragm motion that mimics normal breathing and creates negative chest pressure. “A lot of hypothesis generation needs to happen to better understand the underlying physiology,” Dr. Goldberg conceded.
At the end of the 6-month period that compared active treatment with control, the heart failure subgroup also showed statistically significant benefits from treatment for several sleep metrics, including apnea-hypopnea index, the central apnea index, and oxygen desaturation, and also for daytime sleepiness measured on the Epworth Sleepiness Scale. After 12 months on active treatment, patients also showed a significant improvement over baseline in their score on the Minnesota Living With Heart Failure Questionnaire, Dr. Goldberg reported.
The trial was sponsored by Respicardia, the company developing the remedē System. Dr. Goldberg has been a consultant to and has received research funding from Respicardia. Dr. Stevenson had no relevant disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
DALLAS– Heart failure patients with central sleep apnea who received treatment with a transvenous phrenic nerve–stimulating device showed dramatic improvement in their global self-assessment, compared with control patients, in a subgroup analysis of 80 patients enrolled in the device’s pivotal trial.
Among 35 patients with heart failure enrolled in the remedē System pivotal trial and treated for 6 months with phrenic nerve stimulation, 57% reported that they had “markedly” or “moderately” improved, compared with a 9% rate for this self-rating among 44 control heart failure patients in the trial, a statistically significant difference, Lee R. Goldberg, MD, said at the annual scientific meeting of the Heart Failure Society of America.
Further analysis focused on echocardiographic examinations after 12 months in 23 of the heart failure patients who entered the study with a left ventricular ejection fraction of 45% or less and received 12 months of phrenic nerve stimulation. The average LVEF rose in these patients from 30% at baseline to 35%, a statistically significant difference, and left ventricular end systolic volume fell by an average of almost 11 mL from baseline, a difference just short of statistical significance, findings Dr. Goldberg called “a little exciting.”
“It is very encouraging to see some evidence for ventricular remodeling,” commented Lynne W. Stevenson, MD, professor of medicine and a heart failure specialist at Vanderbilt University in Nashville, Tenn.
The FDA approved the use of this device for the treatment of moderate to severe central sleep apnea on Oct. 6. “I think we would use it” in heart failure patients with intolerable symptoms from central sleep apnea, Dr. Goldberg said in an interview during the meeting.
“There is a tight connection between sleep-disordered breathing, sleep apnea, heart failure, and cardiovascular disease, and we have been pretty aggressive in trying to treat the sleep apnea. Even if phrenic nerve stimulation just improves patients’ quality of life and is neutral for other outcomes,” it would be reasonable to offer it to patients, he said. “But many of us think there is a bigger connection that results in a therapeutic benefit [to heart failure patients] by treating their central sleep apnea.”
The pivotal trial enrolled a total of 151 patients with central sleep apnea at 31 centers in Germany, Poland, and the United States who were selected based on having an apnea-hypopnea index of at least 20 events per hour. All participants received a transvenous phrenic nerve–stimulator implant, and then randomization assigned 73 patients to have the device turned on for the first 6 months while 78 device recipients had their devices left off to serve as controls. The study’s primary efficacy endpoint was the percentage of patients having at least a 50% cut in their apnea-hypopnea index, which happened in 51% of evaluable patients in the active treatment arm and in 11% of the evaluable controls. The primary results were published last year (Lancet. 2016 Sep 3;388[10048]974-82).
“We hope this treatment will have the collateral effect of improving cardiovascular disease outcomes, but we don’t know that yet. The initial target will be patients with apnea-hypopnea episodes that affect their quality of life,” Dr. Goldberg said.
The apparent safety of this approach for treating central sleep apnea may relate to its mechanism of action, he suggested. The mortality-boosting effect of adaptive servo-ventilation may correlate with the positive pressure it creates in a patient’s chest that perhaps causes myocardial stress or hemodynamic problems. In contrast, phrenic nerve stimulation produces diaphragm motion that mimics normal breathing and creates negative chest pressure. “A lot of hypothesis generation needs to happen to better understand the underlying physiology,” Dr. Goldberg conceded.
At the end of the 6-month period that compared active treatment with control, the heart failure subgroup also showed statistically significant benefits from treatment for several sleep metrics, including apnea-hypopnea index, the central apnea index, and oxygen desaturation, and also for daytime sleepiness measured on the Epworth Sleepiness Scale. After 12 months on active treatment, patients also showed a significant improvement over baseline in their score on the Minnesota Living With Heart Failure Questionnaire, Dr. Goldberg reported.
The trial was sponsored by Respicardia, the company developing the remedē System. Dr. Goldberg has been a consultant to and has received research funding from Respicardia. Dr. Stevenson had no relevant disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
DALLAS– Heart failure patients with central sleep apnea who received treatment with a transvenous phrenic nerve–stimulating device showed dramatic improvement in their global self-assessment, compared with control patients, in a subgroup analysis of 80 patients enrolled in the device’s pivotal trial.
Among 35 patients with heart failure enrolled in the remedē System pivotal trial and treated for 6 months with phrenic nerve stimulation, 57% reported that they had “markedly” or “moderately” improved, compared with a 9% rate for this self-rating among 44 control heart failure patients in the trial, a statistically significant difference, Lee R. Goldberg, MD, said at the annual scientific meeting of the Heart Failure Society of America.
Further analysis focused on echocardiographic examinations after 12 months in 23 of the heart failure patients who entered the study with a left ventricular ejection fraction of 45% or less and received 12 months of phrenic nerve stimulation. The average LVEF rose in these patients from 30% at baseline to 35%, a statistically significant difference, and left ventricular end systolic volume fell by an average of almost 11 mL from baseline, a difference just short of statistical significance, findings Dr. Goldberg called “a little exciting.”
“It is very encouraging to see some evidence for ventricular remodeling,” commented Lynne W. Stevenson, MD, professor of medicine and a heart failure specialist at Vanderbilt University in Nashville, Tenn.
The FDA approved the use of this device for the treatment of moderate to severe central sleep apnea on Oct. 6. “I think we would use it” in heart failure patients with intolerable symptoms from central sleep apnea, Dr. Goldberg said in an interview during the meeting.
“There is a tight connection between sleep-disordered breathing, sleep apnea, heart failure, and cardiovascular disease, and we have been pretty aggressive in trying to treat the sleep apnea. Even if phrenic nerve stimulation just improves patients’ quality of life and is neutral for other outcomes,” it would be reasonable to offer it to patients, he said. “But many of us think there is a bigger connection that results in a therapeutic benefit [to heart failure patients] by treating their central sleep apnea.”
The pivotal trial enrolled a total of 151 patients with central sleep apnea at 31 centers in Germany, Poland, and the United States who were selected based on having an apnea-hypopnea index of at least 20 events per hour. All participants received a transvenous phrenic nerve–stimulator implant, and then randomization assigned 73 patients to have the device turned on for the first 6 months while 78 device recipients had their devices left off to serve as controls. The study’s primary efficacy endpoint was the percentage of patients having at least a 50% cut in their apnea-hypopnea index, which happened in 51% of evaluable patients in the active treatment arm and in 11% of the evaluable controls. The primary results were published last year (Lancet. 2016 Sep 3;388[10048]974-82).
“We hope this treatment will have the collateral effect of improving cardiovascular disease outcomes, but we don’t know that yet. The initial target will be patients with apnea-hypopnea episodes that affect their quality of life,” Dr. Goldberg said.
The apparent safety of this approach for treating central sleep apnea may relate to its mechanism of action, he suggested. The mortality-boosting effect of adaptive servo-ventilation may correlate with the positive pressure it creates in a patient’s chest that perhaps causes myocardial stress or hemodynamic problems. In contrast, phrenic nerve stimulation produces diaphragm motion that mimics normal breathing and creates negative chest pressure. “A lot of hypothesis generation needs to happen to better understand the underlying physiology,” Dr. Goldberg conceded.
At the end of the 6-month period that compared active treatment with control, the heart failure subgroup also showed statistically significant benefits from treatment for several sleep metrics, including apnea-hypopnea index, the central apnea index, and oxygen desaturation, and also for daytime sleepiness measured on the Epworth Sleepiness Scale. After 12 months on active treatment, patients also showed a significant improvement over baseline in their score on the Minnesota Living With Heart Failure Questionnaire, Dr. Goldberg reported.
The trial was sponsored by Respicardia, the company developing the remedē System. Dr. Goldberg has been a consultant to and has received research funding from Respicardia. Dr. Stevenson had no relevant disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
AT THE HFSA ANNUAL SCIENTIFIC MEETING
Key clinical point:
Major finding: Patient-reported global assessment improved markedly or moderately in 57% of treated patients and in 9% of controls.
Data source: Subgroup analysis of the remedē System pivotal trial.
Disclosures: The trial was sponsored by Respicardia, the company developing the remedē System. Dr. Goldberg has been a consultant to and has received research funding from Respicardia. Dr. Stevenson had no relevant disclosures.
Consider PBC in diagnosing hepatobiliary disorders in UC patients
While primary sclerosing cholangitis (PSC) is the most common hepatobiliary disorder associated with ulcerative colitis, primary biliary cholangitis (PBC) should not be forgotten, according to Erietta Polychronopoulou, MD, and her associates.
In two case studies, a 67-year-old woman and a 71-year-old man presented with long-standing cases of asymptomatic elevation of cholestatic enzymes. Both patients had long histories of ulcerative colitis, but both were in remission. Both patients had previous clinical diagnoses of either small duct PSC or drug-induced liver injury. Both patients denied drug use, and imaging studies revealed nothing in either patient.
In testing for hepatobiliary disorders, both patients showed high titers of antimitochondrial antibodies, the hallmark of PBC. Despite the asymptomatic nature of the PBC, both patients were treated with 13 mg/kg per day ursodeoxycholic acid and have remained stable for 17 and 18 months, respectively.
“The relationship of PBC with UC [ulcerative colitis] remains obscure as there are few reported cases regarding the combined presentation of these diseases. Although the pathogenesis of either disease has not yet been completely clarified, environmental and genetic factors are considered important in the susceptibility to both diseases, suggesting that the two diseases may share common immunopathogenetic pathways,” the investigators noted.
Find the full report in BMJ Case Reports (2017 Sep 25. doi: 10.1136/bcr-2017-220824).
While primary sclerosing cholangitis (PSC) is the most common hepatobiliary disorder associated with ulcerative colitis, primary biliary cholangitis (PBC) should not be forgotten, according to Erietta Polychronopoulou, MD, and her associates.
In two case studies, a 67-year-old woman and a 71-year-old man presented with long-standing cases of asymptomatic elevation of cholestatic enzymes. Both patients had long histories of ulcerative colitis, but both were in remission. Both patients had previous clinical diagnoses of either small duct PSC or drug-induced liver injury. Both patients denied drug use, and imaging studies revealed nothing in either patient.
In testing for hepatobiliary disorders, both patients showed high titers of antimitochondrial antibodies, the hallmark of PBC. Despite the asymptomatic nature of the PBC, both patients were treated with 13 mg/kg per day ursodeoxycholic acid and have remained stable for 17 and 18 months, respectively.
“The relationship of PBC with UC [ulcerative colitis] remains obscure as there are few reported cases regarding the combined presentation of these diseases. Although the pathogenesis of either disease has not yet been completely clarified, environmental and genetic factors are considered important in the susceptibility to both diseases, suggesting that the two diseases may share common immunopathogenetic pathways,” the investigators noted.
Find the full report in BMJ Case Reports (2017 Sep 25. doi: 10.1136/bcr-2017-220824).
While primary sclerosing cholangitis (PSC) is the most common hepatobiliary disorder associated with ulcerative colitis, primary biliary cholangitis (PBC) should not be forgotten, according to Erietta Polychronopoulou, MD, and her associates.
In two case studies, a 67-year-old woman and a 71-year-old man presented with long-standing cases of asymptomatic elevation of cholestatic enzymes. Both patients had long histories of ulcerative colitis, but both were in remission. Both patients had previous clinical diagnoses of either small duct PSC or drug-induced liver injury. Both patients denied drug use, and imaging studies revealed nothing in either patient.
In testing for hepatobiliary disorders, both patients showed high titers of antimitochondrial antibodies, the hallmark of PBC. Despite the asymptomatic nature of the PBC, both patients were treated with 13 mg/kg per day ursodeoxycholic acid and have remained stable for 17 and 18 months, respectively.
“The relationship of PBC with UC [ulcerative colitis] remains obscure as there are few reported cases regarding the combined presentation of these diseases. Although the pathogenesis of either disease has not yet been completely clarified, environmental and genetic factors are considered important in the susceptibility to both diseases, suggesting that the two diseases may share common immunopathogenetic pathways,” the investigators noted.
Find the full report in BMJ Case Reports (2017 Sep 25. doi: 10.1136/bcr-2017-220824).
FROM BMJ CASE REPORTS
Cardio-oncology booms but awareness lags
Cardio-oncology is expanding, fed by a steadily increasing population of cancer survivors at elevated risk for a range of cardiovascular diseases and complications because of the anticancer treatments they received. Cardio-oncology’s quick growth has also been driven by the rapidly expanding universe of cancer treatments with direct or indirect adverse effects on a diverse range of cardiovascular functions.
During the past year, the field’s rapid evolution has featured the first formal diagnostic and care standards in two iterations: A position paper on the cardiovascular toxicities of cancer treatment from the European Society of Cardiology (ESC), released in August 2016 (Eur Heart J. 2016 Sept 21;37[36]:2766-801); and a guideline for preventing and monitoring cardiac dysfunction in adult cancer survivors, issued last December by the American Society of Clinical Oncology (ASCO) and endorsed by the American Heart Association (J Clin Oncol. 2017 March 10;35[8]:893-913), but notably not endorsed by the American College of Cardiology, despite having an ACC representative on the guideline panel. In 2015, the ACC started a Cardio-Oncology Section, one of 20 special-interest sections it maintains, and by mid-2017 the section had some 500 members.
“I’ve had recent conversations with cardiologists who said ‘I’m not sure what cardio-oncology is,’ ” said Tomas G. Neilan, MD, director of the cardio-oncology program at Massachusetts General Hospital in Boston.
More than just heart failure
A few decades ago, in the primordial days of cardio-oncology, the concept of cardiovascular damage during cancer therapy focused entirely on myocardial damage caused by anthracyclines and chest radiation, a concern that eventually expanded to include trastuzumab (Herceptin) and other agents that target the human epidermal growth factor receptor 2 (HER2). These treatments cause significantly reduced left ventricular ejection fractions and heart failure in a significant minority of treated patients. Patients who receive combined treatment with an anthracycline and trastuzumab are at the highest risk for developing heart failure with reduced ejection fraction, but even among patients treated with this combination, fewer than 5% develop outright heart failure.
While this parochial view of cardio-oncology has recently shifted, it remains true that myocardial damage from a relatively large cumulative anthracycline dose, or from radiation, causes some of the most extreme cases of cardiovascular adverse effects and remains an ongoing problem as these treatments stay front line for selected cancer patients.
But some of the recent burgeoning of cardio-oncology has followed the recognition that many other drugs and drug classes can cause a spectrum of adverse cardiovascular effects.
“There has been a significant focus on heart failure and cardiomyopathy due to anthracyclines and HER2-targeted therapies. I think the field will continue to evolve over the next 5 years to focus on other cardiovascular complications, including arrhythmias and vascular disease,” observed Michael Fradley, MD, director of cardio-oncology at Moffitt Cancer Center in Tampa. “In addition, there will be an increased focus on targeted drugs and immunotherapies,” agents that Dr. Fradley said “have many unique cardiovascular complications. We need additional guidelines regarding the management of a variety of cardiotoxicities as well as long-term monitoring strategies.”
In a review article Dr. Moslehi published toward the end of 2016, he fleshed out the wider scope of adverse cardiovascular effects from cancer therapies, noting that the vascular endothelial growth factor (VEGF) signaling pathway inhibitors, drugs such as bevacizumab (Avastin) and aflibercept (Zaltrap), have been documented to cause hypertension, arterial thromboembolic events, and cardiomyopathy; and that tyrosine kinase inhibitors have been shown to cause vascular events, QT interval prolongation, and cerebral and peripheral vascular events (N Engl J Med. 2016 Oct 13;375[15]:1457-67).
In his own recent review, Dr. Fradley highlighted adverse cardiovascular effects from additional anticancer drug classes, including proteasome inhibitors, which can trigger hypertension and cardiomyopathy; immunomodulators, implicated in causing both venous and arterial thromboembolism; and the immune checkpoint inhibitors, linked with myocarditis, arrhythmias, hypotension, and myocardial ischemia (Eur Heart J. 2016 Sept 21;37[36]:2740-2). A similarly broad spectrum of adverse cardiovascular effects linked with a wide range of anticancer treatments also appeared in the ESC 2016 position paper on cancer treatments.
But while the range of cancer treatments that can have some impact on the cardiovascular system is strikingly large, experts uniformly caution that far from every patient treated for cancer needs an immediate cardiology consult and work-up, especially when the cancers appear in young adults.
“We’re not quite at the point where every cancer patient needs to be seen by a cardiologist or cardio-oncologist,” Dr. Fradley noted in an interview.
“If a patient develops hypertension while on treatment I refer them to a PCP or cardiologist. I don’t treat hypertension myself. But if a patient is ‘normal’ they don’t need a cardiology assessment up front. It’s impossible to refer all patients, especially younger patients, with current resources. There are too many patients who receive cardiotoxic therapies to refer everyone. I involve the cardiologist once there is evidence of damage,”she explained.
Cardio-oncology centers or community practice?
The rise of cardio-oncology, especially over the last decade or so, has given rise to a new academic niche, the cardio-oncology clinic. Starting from almost no programs a few years ago, by 2016 one tally put the total number of U.S. self-designated cardio-oncology centers at about 40 (Heart Fail Clin. 2017 April;13[2]:347-55), and that number undoubtedly grew even more during the year since. While these programs promote and advance the nascent subspecialty of cardio-oncology, and provide a foundation for development of formalized training programs, many experts see a clear hierarchy of risk that distinguishes the patients who should ideally be managed at these focused, multidisciplinary programs from the lower-risk patients who probably do fine under the care of just their oncologist or their oncologist in collaboration with a community cardiologist or primary care physician.
“The cardio-oncology community recognizes that it is nice to have programs at academic centers but it’s more important to deliver this care in the community,” said Dr. Lenihan. “Many cancer patients have no prior history of cardiovascular disease. These low-risk patients don’t necessarily need a cardio-oncologist. They may need to have their blood pressure managed more effectively or receive other preventive care, but that can certainly be done locally. There are low-risk patients who don’t need to go to a major center.” Dr. Lenihan and other cardio-oncologists see the majority of cancer patients as low risk when it comes to cardiovascular complications.
But it’s different when patients receive an anthracycline or an anthracycline plus trastuzumab. “This high-risk population is best seen at a cardio-oncology center.” Dr. Lenihan also included in this high-risk subgroup patients treated with mediastinal radiation, an option often used during the 1980s-2000s.
“Any time a patient receives treatment with the potential to cause a cardiovascular effect, which is pretty much any drug that now comes out, you need an accurate baseline assessment. But that doesn’t mean you need do anything different; you still treat the patient’s cancer. A thorough baseline assessment is a necessity, but it does not need to be done at a cardio-oncology center,” Dr. Lenihan said in an interview.
“For the vast majority of patients, care can be at community hospitals, similar to the delivery of the vast majority of oncology care. Some patients need referral to tertiary cardiology centers for advanced heart failure or to undergo advanced procedures, but that is a very small percentage of patients,” said Ana Barac, MD, director of the cardio-oncology program at the MedStar Heart Institute in Washington, and chair of the ACC’s Cardio-Oncology Section.
“Patients receiving more novel or unusual therapies, and those participating in trials” are appropriate for centers, while community care by a cardiologist and oncologist should suffice for more routine patients, said Dr. Fradley.
“Cardio-oncology centers are good for patients with type I damage from anthracycline treatment, especially patients who already had underlying heart disease,” said Michael S. Ewer, MD, a cardiologist and professor of medicine at MD Anderson Cancer Center in Houston. Specialist centers are also for patients with cardiovascular risk factors: older age, diabetes, preexisting coronary artery disease, and patients who receive cardiotoxic type I therapy (J Clin Oncol. 2005 May;23[13]:2900-2). Also, patients with a significant, immediate cardiac reaction to treatment, and those with an unexpected cardiac reaction, Dr. Ewer said.
A somewhat more expansive view of the typical cardio-oncology patient came from Dr. Neilan, based on the patients he sees at his program in Boston. Dr. Neilan estimated that roughly 60%-70% of his patients first present while they undergo active cancer treatment, with another 20% coming to the program as cancer survivors, and a small percentage of patients showing up for cardiology assessments and treatments without a cancer history. Among those with a cancer history, he guessed that perhaps 10%-20% were treated with an anthracycline, at least 10% received trastuzumab, and about 10% received radiation treatment. “I also see a lot of patients with complications from treatment” with tyrosine kinase inhibitors, VEGF inhibitors, and immunotherapies. “I don’t see a lot of patients for cardiovascular disease assessment before they start cancer therapy,” Dr. Neilan added.
Cardio-oncology heads toward a new cardiology subspecialty
These views of how cardio-oncology is practiced in the real world raise a question about the role of the growing roster of U.S. cardio-oncology programs. If most cancer patients can have their cardiology needs taken care of in the community, how do all the academic programs fit in? The answer seems to be that they model successful oncology and cardiology collaborations, provide a training ground for physicians from both specialties to learn how to collaborate, and serve as the home for research that broadens the field’s evidence base and moves knowledge forward.
“Education and partnerships with oncology teams is the key,” said Dr. Barac. “Our traditional subspecialty training focused on ‘treating cancer’ and ‘treating cardiovascular disease.’ Learning about and seeing effective partnerships during training” is the best model to foster cardiology and oncology partnerships among early-career physicians, she suggested.
“What is the spectrum of knowledge required to be proficient in cardio-oncology, and how do we enhance training at the resident or fellowship level? How do we get [all cardiology] trainees exposed to this knowledge?” wondered Dr. Lenihan, who viewed cardio-oncology programs as a way to meet these needs. “Cardio-oncology is not an established subspecialty. A goal is to establish training requirements and expand training opportunities. And the whole field needs to contribute to clinical research. We need cardio-oncologists to share their experience and improve our level of research.”
ASCO’s cardiac dysfunction practice guideline, first released last December and formally published in March, is likely helping to further entrench cardio-oncology as a new subspecialty. The guideline was “a remarkable step forward,” said Dr. Barac. In addition to establishing a U.S. standard of care for preventing and monitoring cardiac dysfunction in cancer patients, “I use it as a guide for creation of referral pathways with my oncology colleagues, as well as in education of cardiovascular and oncology trainees,” she said in an interview.
Though produced primarily through ASCO’s leadership, the target audience for the guideline seems to be as much cardiologists as it is oncologists. Dissemination of the guideline to cardiologists snagged when it failed to appear in the cardiology literature. That wasn’t the original plan, said guideline participants.
“Before we started, it was agreed that both ASCO and the ACC would publish it. We had a [letter] signed by the president of the ACC saying the ACC would publish it,” recalled Dr. Lenihan, a guideline coauthor. “After all the details were settled, the ACC bailed. They said that they had changed their organizational structure and that they wouldn’t publish the guideline even though they had agreed to.” Not having the guideline appear simultaneously in the cardiology literature “hinders getting the message to the cardiology community,” he said, a sentiment echoed by other cardio-oncologists.
“I served as the ACC representative on the guideline, and the lack of ACC endorsement was the unfortunate consequence of approval and publication timing that coincided with restructuring of the ACC committees,” said Dr. Barac. “It absolutely does not reflect a lack of interest from the ACC.” As an example of the College’s commitment example, she cited an ACC 1.5-day educational course on cardiovascular care of oncology patients held for the first time in February 2017 and scheduled for a second edition next February.
Publication of the guideline in a cardiology journal “would indeed help dissemination among U.S. cardiologists,” agreed Pamela S. Douglas, MD, professor of medicine at Duke University in Durham, N.C., and another of the several cardiologists who served on the ASCO guideline’s panel.
Further advancing awareness of patients with cardio-oncology issues, what Dr. Moslehi has called “an emerging epidemic,” seems the most fundamental of the goals currently advanced by many active in this field.
One step to grow the subspecialty that he and his associates at Vanderbilt have taken is to start this year a formally recognized fellowship program in cardio-oncology; an initial class of three cardiologists started in the program this summer. The Vanderbilt group also plans to launch a website before the end of 2017 that will include an oncology-drug database that compiles all available information on each agent’s cardiovascular effects. The planned website will aggregate links to all existing cardio-oncology programs.
“We will absolutely see the field grow,” said Dr. Swain. “It has only sprung up in the past 10 or so years. It is now getting recognition, people are being trained in cardio-oncology, and it will grow as a subspecialty. It’s very exciting, and it’s better for patients.”
“A cardiologist with no cancer patients or survivors in their practice is unheard of; many cardiologists just don’t realize that,” Dr. Lenihan said. At least 10%-15% of the U.S. population in their 60s or older has a cancer history, he noted. The common mindset among cardiologists has been that cancer patients and survivors are not among their patients.
“It’s unlikely that a busy cardiology practice has no cancer survivors or active cancer patients,” Dr. Douglas suggested. When this happens, a likely explanations is that the cardiologist simply failed to elicit a completely comprehensive history from the practice’s patient roster. And even a cardiology practice today that includes no cancer patients or survivors will likely see some turning up soon, she predicted, because so many are receiving cardiovascular-toxic therapies and then surviving longer than ever before.
“What oncologists and cardiologists want to do is to optimize oncologic outcomes but with an acceptable adverse event profile. The cardio-oncologist helps push that envelope. The goal is not to eliminate cardiac events at the expense of oncologic outcomes, but to shift the balance to fewer and less severe cardiac events without unduly compromising oncologic outcomes,” explained Dr. Ewer. Cardio-oncology grapples with one of the core challenges of medicine, how to balance the potential risks from treatment against its potential benefits, he observed.
Dr. Neilan has been a consultant to Ariad and Takeda. Dr. Lenihan has been a consultant to Janssen and Roche and has received research funding from Takeda. Dr. Moslehi has been a consultant to Acceleron, Ariad, Bristol-Myers Squibb, Incyte, Pfizer, Takeda/Millennium, Verastem and Vertex. Dr. Ewer, Dr. Fradley, and Dr. Barac had no relevant disclosures. Dr. Swain has been a consultant to Genentech and Roche. Dr. Douglas has been a consultant to CardioDx, Interleukin Genetics, and Omicia, and has an ownership interest in CardioDx.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
Cardio-oncology is expanding, fed by a steadily increasing population of cancer survivors at elevated risk for a range of cardiovascular diseases and complications because of the anticancer treatments they received. Cardio-oncology’s quick growth has also been driven by the rapidly expanding universe of cancer treatments with direct or indirect adverse effects on a diverse range of cardiovascular functions.
During the past year, the field’s rapid evolution has featured the first formal diagnostic and care standards in two iterations: A position paper on the cardiovascular toxicities of cancer treatment from the European Society of Cardiology (ESC), released in August 2016 (Eur Heart J. 2016 Sept 21;37[36]:2766-801); and a guideline for preventing and monitoring cardiac dysfunction in adult cancer survivors, issued last December by the American Society of Clinical Oncology (ASCO) and endorsed by the American Heart Association (J Clin Oncol. 2017 March 10;35[8]:893-913), but notably not endorsed by the American College of Cardiology, despite having an ACC representative on the guideline panel. In 2015, the ACC started a Cardio-Oncology Section, one of 20 special-interest sections it maintains, and by mid-2017 the section had some 500 members.
“I’ve had recent conversations with cardiologists who said ‘I’m not sure what cardio-oncology is,’ ” said Tomas G. Neilan, MD, director of the cardio-oncology program at Massachusetts General Hospital in Boston.
More than just heart failure
A few decades ago, in the primordial days of cardio-oncology, the concept of cardiovascular damage during cancer therapy focused entirely on myocardial damage caused by anthracyclines and chest radiation, a concern that eventually expanded to include trastuzumab (Herceptin) and other agents that target the human epidermal growth factor receptor 2 (HER2). These treatments cause significantly reduced left ventricular ejection fractions and heart failure in a significant minority of treated patients. Patients who receive combined treatment with an anthracycline and trastuzumab are at the highest risk for developing heart failure with reduced ejection fraction, but even among patients treated with this combination, fewer than 5% develop outright heart failure.
While this parochial view of cardio-oncology has recently shifted, it remains true that myocardial damage from a relatively large cumulative anthracycline dose, or from radiation, causes some of the most extreme cases of cardiovascular adverse effects and remains an ongoing problem as these treatments stay front line for selected cancer patients.
But some of the recent burgeoning of cardio-oncology has followed the recognition that many other drugs and drug classes can cause a spectrum of adverse cardiovascular effects.
“There has been a significant focus on heart failure and cardiomyopathy due to anthracyclines and HER2-targeted therapies. I think the field will continue to evolve over the next 5 years to focus on other cardiovascular complications, including arrhythmias and vascular disease,” observed Michael Fradley, MD, director of cardio-oncology at Moffitt Cancer Center in Tampa. “In addition, there will be an increased focus on targeted drugs and immunotherapies,” agents that Dr. Fradley said “have many unique cardiovascular complications. We need additional guidelines regarding the management of a variety of cardiotoxicities as well as long-term monitoring strategies.”
In a review article Dr. Moslehi published toward the end of 2016, he fleshed out the wider scope of adverse cardiovascular effects from cancer therapies, noting that the vascular endothelial growth factor (VEGF) signaling pathway inhibitors, drugs such as bevacizumab (Avastin) and aflibercept (Zaltrap), have been documented to cause hypertension, arterial thromboembolic events, and cardiomyopathy; and that tyrosine kinase inhibitors have been shown to cause vascular events, QT interval prolongation, and cerebral and peripheral vascular events (N Engl J Med. 2016 Oct 13;375[15]:1457-67).
In his own recent review, Dr. Fradley highlighted adverse cardiovascular effects from additional anticancer drug classes, including proteasome inhibitors, which can trigger hypertension and cardiomyopathy; immunomodulators, implicated in causing both venous and arterial thromboembolism; and the immune checkpoint inhibitors, linked with myocarditis, arrhythmias, hypotension, and myocardial ischemia (Eur Heart J. 2016 Sept 21;37[36]:2740-2). A similarly broad spectrum of adverse cardiovascular effects linked with a wide range of anticancer treatments also appeared in the ESC 2016 position paper on cancer treatments.
But while the range of cancer treatments that can have some impact on the cardiovascular system is strikingly large, experts uniformly caution that far from every patient treated for cancer needs an immediate cardiology consult and work-up, especially when the cancers appear in young adults.
“We’re not quite at the point where every cancer patient needs to be seen by a cardiologist or cardio-oncologist,” Dr. Fradley noted in an interview.
“If a patient develops hypertension while on treatment I refer them to a PCP or cardiologist. I don’t treat hypertension myself. But if a patient is ‘normal’ they don’t need a cardiology assessment up front. It’s impossible to refer all patients, especially younger patients, with current resources. There are too many patients who receive cardiotoxic therapies to refer everyone. I involve the cardiologist once there is evidence of damage,”she explained.
Cardio-oncology centers or community practice?
The rise of cardio-oncology, especially over the last decade or so, has given rise to a new academic niche, the cardio-oncology clinic. Starting from almost no programs a few years ago, by 2016 one tally put the total number of U.S. self-designated cardio-oncology centers at about 40 (Heart Fail Clin. 2017 April;13[2]:347-55), and that number undoubtedly grew even more during the year since. While these programs promote and advance the nascent subspecialty of cardio-oncology, and provide a foundation for development of formalized training programs, many experts see a clear hierarchy of risk that distinguishes the patients who should ideally be managed at these focused, multidisciplinary programs from the lower-risk patients who probably do fine under the care of just their oncologist or their oncologist in collaboration with a community cardiologist or primary care physician.
“The cardio-oncology community recognizes that it is nice to have programs at academic centers but it’s more important to deliver this care in the community,” said Dr. Lenihan. “Many cancer patients have no prior history of cardiovascular disease. These low-risk patients don’t necessarily need a cardio-oncologist. They may need to have their blood pressure managed more effectively or receive other preventive care, but that can certainly be done locally. There are low-risk patients who don’t need to go to a major center.” Dr. Lenihan and other cardio-oncologists see the majority of cancer patients as low risk when it comes to cardiovascular complications.
But it’s different when patients receive an anthracycline or an anthracycline plus trastuzumab. “This high-risk population is best seen at a cardio-oncology center.” Dr. Lenihan also included in this high-risk subgroup patients treated with mediastinal radiation, an option often used during the 1980s-2000s.
“Any time a patient receives treatment with the potential to cause a cardiovascular effect, which is pretty much any drug that now comes out, you need an accurate baseline assessment. But that doesn’t mean you need do anything different; you still treat the patient’s cancer. A thorough baseline assessment is a necessity, but it does not need to be done at a cardio-oncology center,” Dr. Lenihan said in an interview.
“For the vast majority of patients, care can be at community hospitals, similar to the delivery of the vast majority of oncology care. Some patients need referral to tertiary cardiology centers for advanced heart failure or to undergo advanced procedures, but that is a very small percentage of patients,” said Ana Barac, MD, director of the cardio-oncology program at the MedStar Heart Institute in Washington, and chair of the ACC’s Cardio-Oncology Section.
“Patients receiving more novel or unusual therapies, and those participating in trials” are appropriate for centers, while community care by a cardiologist and oncologist should suffice for more routine patients, said Dr. Fradley.
“Cardio-oncology centers are good for patients with type I damage from anthracycline treatment, especially patients who already had underlying heart disease,” said Michael S. Ewer, MD, a cardiologist and professor of medicine at MD Anderson Cancer Center in Houston. Specialist centers are also for patients with cardiovascular risk factors: older age, diabetes, preexisting coronary artery disease, and patients who receive cardiotoxic type I therapy (J Clin Oncol. 2005 May;23[13]:2900-2). Also, patients with a significant, immediate cardiac reaction to treatment, and those with an unexpected cardiac reaction, Dr. Ewer said.
A somewhat more expansive view of the typical cardio-oncology patient came from Dr. Neilan, based on the patients he sees at his program in Boston. Dr. Neilan estimated that roughly 60%-70% of his patients first present while they undergo active cancer treatment, with another 20% coming to the program as cancer survivors, and a small percentage of patients showing up for cardiology assessments and treatments without a cancer history. Among those with a cancer history, he guessed that perhaps 10%-20% were treated with an anthracycline, at least 10% received trastuzumab, and about 10% received radiation treatment. “I also see a lot of patients with complications from treatment” with tyrosine kinase inhibitors, VEGF inhibitors, and immunotherapies. “I don’t see a lot of patients for cardiovascular disease assessment before they start cancer therapy,” Dr. Neilan added.
Cardio-oncology heads toward a new cardiology subspecialty
These views of how cardio-oncology is practiced in the real world raise a question about the role of the growing roster of U.S. cardio-oncology programs. If most cancer patients can have their cardiology needs taken care of in the community, how do all the academic programs fit in? The answer seems to be that they model successful oncology and cardiology collaborations, provide a training ground for physicians from both specialties to learn how to collaborate, and serve as the home for research that broadens the field’s evidence base and moves knowledge forward.
“Education and partnerships with oncology teams is the key,” said Dr. Barac. “Our traditional subspecialty training focused on ‘treating cancer’ and ‘treating cardiovascular disease.’ Learning about and seeing effective partnerships during training” is the best model to foster cardiology and oncology partnerships among early-career physicians, she suggested.
“What is the spectrum of knowledge required to be proficient in cardio-oncology, and how do we enhance training at the resident or fellowship level? How do we get [all cardiology] trainees exposed to this knowledge?” wondered Dr. Lenihan, who viewed cardio-oncology programs as a way to meet these needs. “Cardio-oncology is not an established subspecialty. A goal is to establish training requirements and expand training opportunities. And the whole field needs to contribute to clinical research. We need cardio-oncologists to share their experience and improve our level of research.”
ASCO’s cardiac dysfunction practice guideline, first released last December and formally published in March, is likely helping to further entrench cardio-oncology as a new subspecialty. The guideline was “a remarkable step forward,” said Dr. Barac. In addition to establishing a U.S. standard of care for preventing and monitoring cardiac dysfunction in cancer patients, “I use it as a guide for creation of referral pathways with my oncology colleagues, as well as in education of cardiovascular and oncology trainees,” she said in an interview.
Though produced primarily through ASCO’s leadership, the target audience for the guideline seems to be as much cardiologists as it is oncologists. Dissemination of the guideline to cardiologists snagged when it failed to appear in the cardiology literature. That wasn’t the original plan, said guideline participants.
“Before we started, it was agreed that both ASCO and the ACC would publish it. We had a [letter] signed by the president of the ACC saying the ACC would publish it,” recalled Dr. Lenihan, a guideline coauthor. “After all the details were settled, the ACC bailed. They said that they had changed their organizational structure and that they wouldn’t publish the guideline even though they had agreed to.” Not having the guideline appear simultaneously in the cardiology literature “hinders getting the message to the cardiology community,” he said, a sentiment echoed by other cardio-oncologists.
“I served as the ACC representative on the guideline, and the lack of ACC endorsement was the unfortunate consequence of approval and publication timing that coincided with restructuring of the ACC committees,” said Dr. Barac. “It absolutely does not reflect a lack of interest from the ACC.” As an example of the College’s commitment example, she cited an ACC 1.5-day educational course on cardiovascular care of oncology patients held for the first time in February 2017 and scheduled for a second edition next February.
Publication of the guideline in a cardiology journal “would indeed help dissemination among U.S. cardiologists,” agreed Pamela S. Douglas, MD, professor of medicine at Duke University in Durham, N.C., and another of the several cardiologists who served on the ASCO guideline’s panel.
Further advancing awareness of patients with cardio-oncology issues, what Dr. Moslehi has called “an emerging epidemic,” seems the most fundamental of the goals currently advanced by many active in this field.
One step to grow the subspecialty that he and his associates at Vanderbilt have taken is to start this year a formally recognized fellowship program in cardio-oncology; an initial class of three cardiologists started in the program this summer. The Vanderbilt group also plans to launch a website before the end of 2017 that will include an oncology-drug database that compiles all available information on each agent’s cardiovascular effects. The planned website will aggregate links to all existing cardio-oncology programs.
“We will absolutely see the field grow,” said Dr. Swain. “It has only sprung up in the past 10 or so years. It is now getting recognition, people are being trained in cardio-oncology, and it will grow as a subspecialty. It’s very exciting, and it’s better for patients.”
“A cardiologist with no cancer patients or survivors in their practice is unheard of; many cardiologists just don’t realize that,” Dr. Lenihan said. At least 10%-15% of the U.S. population in their 60s or older has a cancer history, he noted. The common mindset among cardiologists has been that cancer patients and survivors are not among their patients.
“It’s unlikely that a busy cardiology practice has no cancer survivors or active cancer patients,” Dr. Douglas suggested. When this happens, a likely explanations is that the cardiologist simply failed to elicit a completely comprehensive history from the practice’s patient roster. And even a cardiology practice today that includes no cancer patients or survivors will likely see some turning up soon, she predicted, because so many are receiving cardiovascular-toxic therapies and then surviving longer than ever before.
“What oncologists and cardiologists want to do is to optimize oncologic outcomes but with an acceptable adverse event profile. The cardio-oncologist helps push that envelope. The goal is not to eliminate cardiac events at the expense of oncologic outcomes, but to shift the balance to fewer and less severe cardiac events without unduly compromising oncologic outcomes,” explained Dr. Ewer. Cardio-oncology grapples with one of the core challenges of medicine, how to balance the potential risks from treatment against its potential benefits, he observed.
Dr. Neilan has been a consultant to Ariad and Takeda. Dr. Lenihan has been a consultant to Janssen and Roche and has received research funding from Takeda. Dr. Moslehi has been a consultant to Acceleron, Ariad, Bristol-Myers Squibb, Incyte, Pfizer, Takeda/Millennium, Verastem and Vertex. Dr. Ewer, Dr. Fradley, and Dr. Barac had no relevant disclosures. Dr. Swain has been a consultant to Genentech and Roche. Dr. Douglas has been a consultant to CardioDx, Interleukin Genetics, and Omicia, and has an ownership interest in CardioDx.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
Cardio-oncology is expanding, fed by a steadily increasing population of cancer survivors at elevated risk for a range of cardiovascular diseases and complications because of the anticancer treatments they received. Cardio-oncology’s quick growth has also been driven by the rapidly expanding universe of cancer treatments with direct or indirect adverse effects on a diverse range of cardiovascular functions.
During the past year, the field’s rapid evolution has featured the first formal diagnostic and care standards in two iterations: A position paper on the cardiovascular toxicities of cancer treatment from the European Society of Cardiology (ESC), released in August 2016 (Eur Heart J. 2016 Sept 21;37[36]:2766-801); and a guideline for preventing and monitoring cardiac dysfunction in adult cancer survivors, issued last December by the American Society of Clinical Oncology (ASCO) and endorsed by the American Heart Association (J Clin Oncol. 2017 March 10;35[8]:893-913), but notably not endorsed by the American College of Cardiology, despite having an ACC representative on the guideline panel. In 2015, the ACC started a Cardio-Oncology Section, one of 20 special-interest sections it maintains, and by mid-2017 the section had some 500 members.
“I’ve had recent conversations with cardiologists who said ‘I’m not sure what cardio-oncology is,’ ” said Tomas G. Neilan, MD, director of the cardio-oncology program at Massachusetts General Hospital in Boston.
More than just heart failure
A few decades ago, in the primordial days of cardio-oncology, the concept of cardiovascular damage during cancer therapy focused entirely on myocardial damage caused by anthracyclines and chest radiation, a concern that eventually expanded to include trastuzumab (Herceptin) and other agents that target the human epidermal growth factor receptor 2 (HER2). These treatments cause significantly reduced left ventricular ejection fractions and heart failure in a significant minority of treated patients. Patients who receive combined treatment with an anthracycline and trastuzumab are at the highest risk for developing heart failure with reduced ejection fraction, but even among patients treated with this combination, fewer than 5% develop outright heart failure.
While this parochial view of cardio-oncology has recently shifted, it remains true that myocardial damage from a relatively large cumulative anthracycline dose, or from radiation, causes some of the most extreme cases of cardiovascular adverse effects and remains an ongoing problem as these treatments stay front line for selected cancer patients.
But some of the recent burgeoning of cardio-oncology has followed the recognition that many other drugs and drug classes can cause a spectrum of adverse cardiovascular effects.
“There has been a significant focus on heart failure and cardiomyopathy due to anthracyclines and HER2-targeted therapies. I think the field will continue to evolve over the next 5 years to focus on other cardiovascular complications, including arrhythmias and vascular disease,” observed Michael Fradley, MD, director of cardio-oncology at Moffitt Cancer Center in Tampa. “In addition, there will be an increased focus on targeted drugs and immunotherapies,” agents that Dr. Fradley said “have many unique cardiovascular complications. We need additional guidelines regarding the management of a variety of cardiotoxicities as well as long-term monitoring strategies.”
In a review article Dr. Moslehi published toward the end of 2016, he fleshed out the wider scope of adverse cardiovascular effects from cancer therapies, noting that the vascular endothelial growth factor (VEGF) signaling pathway inhibitors, drugs such as bevacizumab (Avastin) and aflibercept (Zaltrap), have been documented to cause hypertension, arterial thromboembolic events, and cardiomyopathy; and that tyrosine kinase inhibitors have been shown to cause vascular events, QT interval prolongation, and cerebral and peripheral vascular events (N Engl J Med. 2016 Oct 13;375[15]:1457-67).
In his own recent review, Dr. Fradley highlighted adverse cardiovascular effects from additional anticancer drug classes, including proteasome inhibitors, which can trigger hypertension and cardiomyopathy; immunomodulators, implicated in causing both venous and arterial thromboembolism; and the immune checkpoint inhibitors, linked with myocarditis, arrhythmias, hypotension, and myocardial ischemia (Eur Heart J. 2016 Sept 21;37[36]:2740-2). A similarly broad spectrum of adverse cardiovascular effects linked with a wide range of anticancer treatments also appeared in the ESC 2016 position paper on cancer treatments.
But while the range of cancer treatments that can have some impact on the cardiovascular system is strikingly large, experts uniformly caution that far from every patient treated for cancer needs an immediate cardiology consult and work-up, especially when the cancers appear in young adults.
“We’re not quite at the point where every cancer patient needs to be seen by a cardiologist or cardio-oncologist,” Dr. Fradley noted in an interview.
“If a patient develops hypertension while on treatment I refer them to a PCP or cardiologist. I don’t treat hypertension myself. But if a patient is ‘normal’ they don’t need a cardiology assessment up front. It’s impossible to refer all patients, especially younger patients, with current resources. There are too many patients who receive cardiotoxic therapies to refer everyone. I involve the cardiologist once there is evidence of damage,”she explained.
Cardio-oncology centers or community practice?
The rise of cardio-oncology, especially over the last decade or so, has given rise to a new academic niche, the cardio-oncology clinic. Starting from almost no programs a few years ago, by 2016 one tally put the total number of U.S. self-designated cardio-oncology centers at about 40 (Heart Fail Clin. 2017 April;13[2]:347-55), and that number undoubtedly grew even more during the year since. While these programs promote and advance the nascent subspecialty of cardio-oncology, and provide a foundation for development of formalized training programs, many experts see a clear hierarchy of risk that distinguishes the patients who should ideally be managed at these focused, multidisciplinary programs from the lower-risk patients who probably do fine under the care of just their oncologist or their oncologist in collaboration with a community cardiologist or primary care physician.
“The cardio-oncology community recognizes that it is nice to have programs at academic centers but it’s more important to deliver this care in the community,” said Dr. Lenihan. “Many cancer patients have no prior history of cardiovascular disease. These low-risk patients don’t necessarily need a cardio-oncologist. They may need to have their blood pressure managed more effectively or receive other preventive care, but that can certainly be done locally. There are low-risk patients who don’t need to go to a major center.” Dr. Lenihan and other cardio-oncologists see the majority of cancer patients as low risk when it comes to cardiovascular complications.
But it’s different when patients receive an anthracycline or an anthracycline plus trastuzumab. “This high-risk population is best seen at a cardio-oncology center.” Dr. Lenihan also included in this high-risk subgroup patients treated with mediastinal radiation, an option often used during the 1980s-2000s.
“Any time a patient receives treatment with the potential to cause a cardiovascular effect, which is pretty much any drug that now comes out, you need an accurate baseline assessment. But that doesn’t mean you need do anything different; you still treat the patient’s cancer. A thorough baseline assessment is a necessity, but it does not need to be done at a cardio-oncology center,” Dr. Lenihan said in an interview.
“For the vast majority of patients, care can be at community hospitals, similar to the delivery of the vast majority of oncology care. Some patients need referral to tertiary cardiology centers for advanced heart failure or to undergo advanced procedures, but that is a very small percentage of patients,” said Ana Barac, MD, director of the cardio-oncology program at the MedStar Heart Institute in Washington, and chair of the ACC’s Cardio-Oncology Section.
“Patients receiving more novel or unusual therapies, and those participating in trials” are appropriate for centers, while community care by a cardiologist and oncologist should suffice for more routine patients, said Dr. Fradley.
“Cardio-oncology centers are good for patients with type I damage from anthracycline treatment, especially patients who already had underlying heart disease,” said Michael S. Ewer, MD, a cardiologist and professor of medicine at MD Anderson Cancer Center in Houston. Specialist centers are also for patients with cardiovascular risk factors: older age, diabetes, preexisting coronary artery disease, and patients who receive cardiotoxic type I therapy (J Clin Oncol. 2005 May;23[13]:2900-2). Also, patients with a significant, immediate cardiac reaction to treatment, and those with an unexpected cardiac reaction, Dr. Ewer said.
A somewhat more expansive view of the typical cardio-oncology patient came from Dr. Neilan, based on the patients he sees at his program in Boston. Dr. Neilan estimated that roughly 60%-70% of his patients first present while they undergo active cancer treatment, with another 20% coming to the program as cancer survivors, and a small percentage of patients showing up for cardiology assessments and treatments without a cancer history. Among those with a cancer history, he guessed that perhaps 10%-20% were treated with an anthracycline, at least 10% received trastuzumab, and about 10% received radiation treatment. “I also see a lot of patients with complications from treatment” with tyrosine kinase inhibitors, VEGF inhibitors, and immunotherapies. “I don’t see a lot of patients for cardiovascular disease assessment before they start cancer therapy,” Dr. Neilan added.
Cardio-oncology heads toward a new cardiology subspecialty
These views of how cardio-oncology is practiced in the real world raise a question about the role of the growing roster of U.S. cardio-oncology programs. If most cancer patients can have their cardiology needs taken care of in the community, how do all the academic programs fit in? The answer seems to be that they model successful oncology and cardiology collaborations, provide a training ground for physicians from both specialties to learn how to collaborate, and serve as the home for research that broadens the field’s evidence base and moves knowledge forward.
“Education and partnerships with oncology teams is the key,” said Dr. Barac. “Our traditional subspecialty training focused on ‘treating cancer’ and ‘treating cardiovascular disease.’ Learning about and seeing effective partnerships during training” is the best model to foster cardiology and oncology partnerships among early-career physicians, she suggested.
“What is the spectrum of knowledge required to be proficient in cardio-oncology, and how do we enhance training at the resident or fellowship level? How do we get [all cardiology] trainees exposed to this knowledge?” wondered Dr. Lenihan, who viewed cardio-oncology programs as a way to meet these needs. “Cardio-oncology is not an established subspecialty. A goal is to establish training requirements and expand training opportunities. And the whole field needs to contribute to clinical research. We need cardio-oncologists to share their experience and improve our level of research.”
ASCO’s cardiac dysfunction practice guideline, first released last December and formally published in March, is likely helping to further entrench cardio-oncology as a new subspecialty. The guideline was “a remarkable step forward,” said Dr. Barac. In addition to establishing a U.S. standard of care for preventing and monitoring cardiac dysfunction in cancer patients, “I use it as a guide for creation of referral pathways with my oncology colleagues, as well as in education of cardiovascular and oncology trainees,” she said in an interview.
Though produced primarily through ASCO’s leadership, the target audience for the guideline seems to be as much cardiologists as it is oncologists. Dissemination of the guideline to cardiologists snagged when it failed to appear in the cardiology literature. That wasn’t the original plan, said guideline participants.
“Before we started, it was agreed that both ASCO and the ACC would publish it. We had a [letter] signed by the president of the ACC saying the ACC would publish it,” recalled Dr. Lenihan, a guideline coauthor. “After all the details were settled, the ACC bailed. They said that they had changed their organizational structure and that they wouldn’t publish the guideline even though they had agreed to.” Not having the guideline appear simultaneously in the cardiology literature “hinders getting the message to the cardiology community,” he said, a sentiment echoed by other cardio-oncologists.
“I served as the ACC representative on the guideline, and the lack of ACC endorsement was the unfortunate consequence of approval and publication timing that coincided with restructuring of the ACC committees,” said Dr. Barac. “It absolutely does not reflect a lack of interest from the ACC.” As an example of the College’s commitment example, she cited an ACC 1.5-day educational course on cardiovascular care of oncology patients held for the first time in February 2017 and scheduled for a second edition next February.
Publication of the guideline in a cardiology journal “would indeed help dissemination among U.S. cardiologists,” agreed Pamela S. Douglas, MD, professor of medicine at Duke University in Durham, N.C., and another of the several cardiologists who served on the ASCO guideline’s panel.
Further advancing awareness of patients with cardio-oncology issues, what Dr. Moslehi has called “an emerging epidemic,” seems the most fundamental of the goals currently advanced by many active in this field.
One step to grow the subspecialty that he and his associates at Vanderbilt have taken is to start this year a formally recognized fellowship program in cardio-oncology; an initial class of three cardiologists started in the program this summer. The Vanderbilt group also plans to launch a website before the end of 2017 that will include an oncology-drug database that compiles all available information on each agent’s cardiovascular effects. The planned website will aggregate links to all existing cardio-oncology programs.
“We will absolutely see the field grow,” said Dr. Swain. “It has only sprung up in the past 10 or so years. It is now getting recognition, people are being trained in cardio-oncology, and it will grow as a subspecialty. It’s very exciting, and it’s better for patients.”
“A cardiologist with no cancer patients or survivors in their practice is unheard of; many cardiologists just don’t realize that,” Dr. Lenihan said. At least 10%-15% of the U.S. population in their 60s or older has a cancer history, he noted. The common mindset among cardiologists has been that cancer patients and survivors are not among their patients.
“It’s unlikely that a busy cardiology practice has no cancer survivors or active cancer patients,” Dr. Douglas suggested. When this happens, a likely explanations is that the cardiologist simply failed to elicit a completely comprehensive history from the practice’s patient roster. And even a cardiology practice today that includes no cancer patients or survivors will likely see some turning up soon, she predicted, because so many are receiving cardiovascular-toxic therapies and then surviving longer than ever before.
“What oncologists and cardiologists want to do is to optimize oncologic outcomes but with an acceptable adverse event profile. The cardio-oncologist helps push that envelope. The goal is not to eliminate cardiac events at the expense of oncologic outcomes, but to shift the balance to fewer and less severe cardiac events without unduly compromising oncologic outcomes,” explained Dr. Ewer. Cardio-oncology grapples with one of the core challenges of medicine, how to balance the potential risks from treatment against its potential benefits, he observed.
Dr. Neilan has been a consultant to Ariad and Takeda. Dr. Lenihan has been a consultant to Janssen and Roche and has received research funding from Takeda. Dr. Moslehi has been a consultant to Acceleron, Ariad, Bristol-Myers Squibb, Incyte, Pfizer, Takeda/Millennium, Verastem and Vertex. Dr. Ewer, Dr. Fradley, and Dr. Barac had no relevant disclosures. Dr. Swain has been a consultant to Genentech and Roche. Dr. Douglas has been a consultant to CardioDx, Interleukin Genetics, and Omicia, and has an ownership interest in CardioDx.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
