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Upcoming ESC revascularization guidelines cement heart team’s role
PARIS – A joint European Society of Cardiology and European Association for Cardio-Thoracic Surgery task force that will publish revised revascularization guidelines in late August gave a sneak peak of some important elements of the revision, including renewed endorsement of and a refinement to the heart team concept that was first introduced in the prior, 2010 version of the guidelines.
"One of the most important aspects of the 2010 guidelines was the introduction of the heart team (Eur. Heart J. 2010;31:2501-55) said Dr. Philippe H. Kolh. "In 2010, the heart team concept was still controversial, but I think now it is well accepted. We are further supporting and emphasizing the importance of the heart team," he said of the revised guidelines that will be released in August, during a session that previewed selected parts of the new guidelines at the annual congress of the European Association of Percutaneous Cardiovascular Interventions, an organization that also collaborated on the guidelines.
The revision also calls on each institution where operators perform revascularization to establish local protocols to guide the choice in routine cases between percutaneous coronary interventions (PCIs) or coronary artery bypass grafting (CABG), said Dr. Kolh, a cardiac surgeon at University Hospital in Liège, Belgium, and cochairman of the guideline-writing panel.
"The 2010 guidelines produced a misconception that every patient needs to be discussed by a heart team; the 2014 revision makes it clear that the heart team should develop institutional protocols for appropriate revascularization strategies for different types of patients. So if a patient has single-vessel disease, you can go ahead and do PCI and not wait for a heart-team decision," said Dr. Ulf Landmesser, professor and head of the acute cardiology clinic at University Hospital, Zurich, and a member of the 2014 panel. "Hopefully, it will now be clear that the heart team only needs to discuss complex patients that involve difficult decisions, and that institutional protocols can handle routine cases," Dr. Landmesser said.
The revision comes at a time when "the competition today is not so much between CABG and PCI; the more burning question is who should have revascularization, and how do patients get to the cath lab," noted Dr. Spencer B. King III, an interventional cardiologist at St. Joseph’s Medical Group in Atlanta who was invited to the session to comment on the new revision.
Results from a new meta-analysis highlight the critical role of revascularization relative to medical therapy alone in improving outcomes of patients with coronary artery disease. This finding is especially relevant in 2014, because it marks the 50th anniversary of the launch of revascularization with the first successful CABG performed, observed Dr. Stephan Windecker, professor and chief of cardiology at University Hospital in Bern, Switzerland, and cochairman of the guidelines-writing panel.
He presented an analysis of results from 100 randomized, controlled trials that compared some form of revascularization against medical therapy in 93,553 randomized patients followed for more than 260,000 patient-years. The results showed that CABG cut the rate of all-cause mortality by 20%, compared with medical therapy, a statistically significant difference, and that treatment with new-generation drug-eluting stents produced a significant reduction of more than 25%, according to an as-yet unpublished report by members of the European Myocardial Revascularization Collaborative. Dr. Windecker also noted that all the recommendations in the new revision were approved with 100% consensus by the panel, which included cardiac surgeons, interventional cardiologists, and noninterventional cardiologists in equal numbers.
The session highlighted several other notable new elements in the revised guidelines, although Dr. Windecker stressed several times during the session that everything presented remained pending until the final version is released later this summer. The changes include:
• An "upgrade" of the recommendation for PCI use in patients with left main disease and a SYNTAX score of 23-32 to a IIa, "should be considered" class recommendation, boosted from class III "not recommended" status in 2010. Five-year outcomes from the SYNTAX trial showed "no difference in outcomes between PCI and CABG, a major reason to upgrade the recommendation for PCI," said Dr. Landmesser (Lancet 2013;381:629-38). "The guidelines put a lot of weight on SYNTAX score."
• When performing PCI in patients with non–ST-elevation myocardial infarction (NSTEMI), bivalirudin (Angiomax) is recommended exclusively as the anticoagulant to use during and immediately following PCI – with unfractionated heparin recommended only for patients who cannot receive bivalirudin – based on bivalirudin’s proven reduced risk for causing major bleeds, said Dr. Franz-Josef Neumann, professor and director of the University Heart Center in Bad Krozingen, Germany.
• But for patients with ST-elevation MI (STEMI) undergoing primary PCI, unfractionated heparin received the only unqualified, level I recommendation for anticoagulation, with bivalirudin receiving a level IIa, "should be considered" recommendation. This repositioning of the two options occurred, based to some extent on yet unpublished results from a very large, single-center study in Liverpool, HEAT-PPCI, reported at the annual meeting of the American College of Cardiology meeting in March that showed unfractionated heparin outperformed bivalirudin for 28-day outcomes, Dr. Neumann said. "I was very pleased and sort of amazed that results from HEAT-PPCI jumped into the guidelines, and it’s not even published yet. That [recommendation] will have an impact, I suspect," commented Dr. King.
• For patients with either STEMI or NSTEMI, the preferred antiplatelet P2Y12 inhibitors are prasugrel (Effient) and ticagrelor (Brilinta), with clopidogrel reduced to a back-up role "only when prasugrel or ticagrelor are not available," said Dr. Neumann. "I was a little surprised that clopidogrel has fallen off the charts. With the new stents having a low stent thrombosis rate, U.S. physicians tend to stick with clopidogrel; there has been more of a shift in Europe," commented Dr. King. "For elective cases, we still have a clear statement in favor of clopidogrel," countered Dr. Neumann. "It is only for higher risk, acute coronary syndrome and STEMI patients where the guidelines recommend the new agents."
Dr. Kolh said that he has received honoraria from Astra Zeneca and Braun, and research support from Edwards. Dr. Landmesser said that he had no disclosures. Dr. King said that he had no disclosures. Dr. Windecker said that he had received honoraria from, had been a consultant to, or had been a speaker for nine companies and had received research grants from seven companies. Dr. Neumann said that his institution had received research grants from 15 companies.
On Twitter @mitchelzoler
PARIS – A joint European Society of Cardiology and European Association for Cardio-Thoracic Surgery task force that will publish revised revascularization guidelines in late August gave a sneak peak of some important elements of the revision, including renewed endorsement of and a refinement to the heart team concept that was first introduced in the prior, 2010 version of the guidelines.
"One of the most important aspects of the 2010 guidelines was the introduction of the heart team (Eur. Heart J. 2010;31:2501-55) said Dr. Philippe H. Kolh. "In 2010, the heart team concept was still controversial, but I think now it is well accepted. We are further supporting and emphasizing the importance of the heart team," he said of the revised guidelines that will be released in August, during a session that previewed selected parts of the new guidelines at the annual congress of the European Association of Percutaneous Cardiovascular Interventions, an organization that also collaborated on the guidelines.
The revision also calls on each institution where operators perform revascularization to establish local protocols to guide the choice in routine cases between percutaneous coronary interventions (PCIs) or coronary artery bypass grafting (CABG), said Dr. Kolh, a cardiac surgeon at University Hospital in Liège, Belgium, and cochairman of the guideline-writing panel.
"The 2010 guidelines produced a misconception that every patient needs to be discussed by a heart team; the 2014 revision makes it clear that the heart team should develop institutional protocols for appropriate revascularization strategies for different types of patients. So if a patient has single-vessel disease, you can go ahead and do PCI and not wait for a heart-team decision," said Dr. Ulf Landmesser, professor and head of the acute cardiology clinic at University Hospital, Zurich, and a member of the 2014 panel. "Hopefully, it will now be clear that the heart team only needs to discuss complex patients that involve difficult decisions, and that institutional protocols can handle routine cases," Dr. Landmesser said.
The revision comes at a time when "the competition today is not so much between CABG and PCI; the more burning question is who should have revascularization, and how do patients get to the cath lab," noted Dr. Spencer B. King III, an interventional cardiologist at St. Joseph’s Medical Group in Atlanta who was invited to the session to comment on the new revision.
Results from a new meta-analysis highlight the critical role of revascularization relative to medical therapy alone in improving outcomes of patients with coronary artery disease. This finding is especially relevant in 2014, because it marks the 50th anniversary of the launch of revascularization with the first successful CABG performed, observed Dr. Stephan Windecker, professor and chief of cardiology at University Hospital in Bern, Switzerland, and cochairman of the guidelines-writing panel.
He presented an analysis of results from 100 randomized, controlled trials that compared some form of revascularization against medical therapy in 93,553 randomized patients followed for more than 260,000 patient-years. The results showed that CABG cut the rate of all-cause mortality by 20%, compared with medical therapy, a statistically significant difference, and that treatment with new-generation drug-eluting stents produced a significant reduction of more than 25%, according to an as-yet unpublished report by members of the European Myocardial Revascularization Collaborative. Dr. Windecker also noted that all the recommendations in the new revision were approved with 100% consensus by the panel, which included cardiac surgeons, interventional cardiologists, and noninterventional cardiologists in equal numbers.
The session highlighted several other notable new elements in the revised guidelines, although Dr. Windecker stressed several times during the session that everything presented remained pending until the final version is released later this summer. The changes include:
• An "upgrade" of the recommendation for PCI use in patients with left main disease and a SYNTAX score of 23-32 to a IIa, "should be considered" class recommendation, boosted from class III "not recommended" status in 2010. Five-year outcomes from the SYNTAX trial showed "no difference in outcomes between PCI and CABG, a major reason to upgrade the recommendation for PCI," said Dr. Landmesser (Lancet 2013;381:629-38). "The guidelines put a lot of weight on SYNTAX score."
• When performing PCI in patients with non–ST-elevation myocardial infarction (NSTEMI), bivalirudin (Angiomax) is recommended exclusively as the anticoagulant to use during and immediately following PCI – with unfractionated heparin recommended only for patients who cannot receive bivalirudin – based on bivalirudin’s proven reduced risk for causing major bleeds, said Dr. Franz-Josef Neumann, professor and director of the University Heart Center in Bad Krozingen, Germany.
• But for patients with ST-elevation MI (STEMI) undergoing primary PCI, unfractionated heparin received the only unqualified, level I recommendation for anticoagulation, with bivalirudin receiving a level IIa, "should be considered" recommendation. This repositioning of the two options occurred, based to some extent on yet unpublished results from a very large, single-center study in Liverpool, HEAT-PPCI, reported at the annual meeting of the American College of Cardiology meeting in March that showed unfractionated heparin outperformed bivalirudin for 28-day outcomes, Dr. Neumann said. "I was very pleased and sort of amazed that results from HEAT-PPCI jumped into the guidelines, and it’s not even published yet. That [recommendation] will have an impact, I suspect," commented Dr. King.
• For patients with either STEMI or NSTEMI, the preferred antiplatelet P2Y12 inhibitors are prasugrel (Effient) and ticagrelor (Brilinta), with clopidogrel reduced to a back-up role "only when prasugrel or ticagrelor are not available," said Dr. Neumann. "I was a little surprised that clopidogrel has fallen off the charts. With the new stents having a low stent thrombosis rate, U.S. physicians tend to stick with clopidogrel; there has been more of a shift in Europe," commented Dr. King. "For elective cases, we still have a clear statement in favor of clopidogrel," countered Dr. Neumann. "It is only for higher risk, acute coronary syndrome and STEMI patients where the guidelines recommend the new agents."
Dr. Kolh said that he has received honoraria from Astra Zeneca and Braun, and research support from Edwards. Dr. Landmesser said that he had no disclosures. Dr. King said that he had no disclosures. Dr. Windecker said that he had received honoraria from, had been a consultant to, or had been a speaker for nine companies and had received research grants from seven companies. Dr. Neumann said that his institution had received research grants from 15 companies.
On Twitter @mitchelzoler
PARIS – A joint European Society of Cardiology and European Association for Cardio-Thoracic Surgery task force that will publish revised revascularization guidelines in late August gave a sneak peak of some important elements of the revision, including renewed endorsement of and a refinement to the heart team concept that was first introduced in the prior, 2010 version of the guidelines.
"One of the most important aspects of the 2010 guidelines was the introduction of the heart team (Eur. Heart J. 2010;31:2501-55) said Dr. Philippe H. Kolh. "In 2010, the heart team concept was still controversial, but I think now it is well accepted. We are further supporting and emphasizing the importance of the heart team," he said of the revised guidelines that will be released in August, during a session that previewed selected parts of the new guidelines at the annual congress of the European Association of Percutaneous Cardiovascular Interventions, an organization that also collaborated on the guidelines.
The revision also calls on each institution where operators perform revascularization to establish local protocols to guide the choice in routine cases between percutaneous coronary interventions (PCIs) or coronary artery bypass grafting (CABG), said Dr. Kolh, a cardiac surgeon at University Hospital in Liège, Belgium, and cochairman of the guideline-writing panel.
"The 2010 guidelines produced a misconception that every patient needs to be discussed by a heart team; the 2014 revision makes it clear that the heart team should develop institutional protocols for appropriate revascularization strategies for different types of patients. So if a patient has single-vessel disease, you can go ahead and do PCI and not wait for a heart-team decision," said Dr. Ulf Landmesser, professor and head of the acute cardiology clinic at University Hospital, Zurich, and a member of the 2014 panel. "Hopefully, it will now be clear that the heart team only needs to discuss complex patients that involve difficult decisions, and that institutional protocols can handle routine cases," Dr. Landmesser said.
The revision comes at a time when "the competition today is not so much between CABG and PCI; the more burning question is who should have revascularization, and how do patients get to the cath lab," noted Dr. Spencer B. King III, an interventional cardiologist at St. Joseph’s Medical Group in Atlanta who was invited to the session to comment on the new revision.
Results from a new meta-analysis highlight the critical role of revascularization relative to medical therapy alone in improving outcomes of patients with coronary artery disease. This finding is especially relevant in 2014, because it marks the 50th anniversary of the launch of revascularization with the first successful CABG performed, observed Dr. Stephan Windecker, professor and chief of cardiology at University Hospital in Bern, Switzerland, and cochairman of the guidelines-writing panel.
He presented an analysis of results from 100 randomized, controlled trials that compared some form of revascularization against medical therapy in 93,553 randomized patients followed for more than 260,000 patient-years. The results showed that CABG cut the rate of all-cause mortality by 20%, compared with medical therapy, a statistically significant difference, and that treatment with new-generation drug-eluting stents produced a significant reduction of more than 25%, according to an as-yet unpublished report by members of the European Myocardial Revascularization Collaborative. Dr. Windecker also noted that all the recommendations in the new revision were approved with 100% consensus by the panel, which included cardiac surgeons, interventional cardiologists, and noninterventional cardiologists in equal numbers.
The session highlighted several other notable new elements in the revised guidelines, although Dr. Windecker stressed several times during the session that everything presented remained pending until the final version is released later this summer. The changes include:
• An "upgrade" of the recommendation for PCI use in patients with left main disease and a SYNTAX score of 23-32 to a IIa, "should be considered" class recommendation, boosted from class III "not recommended" status in 2010. Five-year outcomes from the SYNTAX trial showed "no difference in outcomes between PCI and CABG, a major reason to upgrade the recommendation for PCI," said Dr. Landmesser (Lancet 2013;381:629-38). "The guidelines put a lot of weight on SYNTAX score."
• When performing PCI in patients with non–ST-elevation myocardial infarction (NSTEMI), bivalirudin (Angiomax) is recommended exclusively as the anticoagulant to use during and immediately following PCI – with unfractionated heparin recommended only for patients who cannot receive bivalirudin – based on bivalirudin’s proven reduced risk for causing major bleeds, said Dr. Franz-Josef Neumann, professor and director of the University Heart Center in Bad Krozingen, Germany.
• But for patients with ST-elevation MI (STEMI) undergoing primary PCI, unfractionated heparin received the only unqualified, level I recommendation for anticoagulation, with bivalirudin receiving a level IIa, "should be considered" recommendation. This repositioning of the two options occurred, based to some extent on yet unpublished results from a very large, single-center study in Liverpool, HEAT-PPCI, reported at the annual meeting of the American College of Cardiology meeting in March that showed unfractionated heparin outperformed bivalirudin for 28-day outcomes, Dr. Neumann said. "I was very pleased and sort of amazed that results from HEAT-PPCI jumped into the guidelines, and it’s not even published yet. That [recommendation] will have an impact, I suspect," commented Dr. King.
• For patients with either STEMI or NSTEMI, the preferred antiplatelet P2Y12 inhibitors are prasugrel (Effient) and ticagrelor (Brilinta), with clopidogrel reduced to a back-up role "only when prasugrel or ticagrelor are not available," said Dr. Neumann. "I was a little surprised that clopidogrel has fallen off the charts. With the new stents having a low stent thrombosis rate, U.S. physicians tend to stick with clopidogrel; there has been more of a shift in Europe," commented Dr. King. "For elective cases, we still have a clear statement in favor of clopidogrel," countered Dr. Neumann. "It is only for higher risk, acute coronary syndrome and STEMI patients where the guidelines recommend the new agents."
Dr. Kolh said that he has received honoraria from Astra Zeneca and Braun, and research support from Edwards. Dr. Landmesser said that he had no disclosures. Dr. King said that he had no disclosures. Dr. Windecker said that he had received honoraria from, had been a consultant to, or had been a speaker for nine companies and had received research grants from seven companies. Dr. Neumann said that his institution had received research grants from 15 companies.
On Twitter @mitchelzoler
EXPERT ANALYSIS FROM EUROPCR 2014
From the Vascular Community: In Memoriam - Dr. John J. Bergan
Vascular pioneer, Dr. John J. Bergan, died on June 11th, 2014.
Dr. Bergan’s illustrious career spanned more than 50 years. He completed his residency at Chicago Wesley Memorial Hospital in 1959 and began his medical career as a clinical assistant in surgery at Northwestern University Medical School. He rose through the ranks at Northwestern and served as the chief of the Division of Transplantation at Northwestern University Medical School from 1969 to 1976. When the Division of Vascular Surgery was formed in 1976, Dr. Bergan was appointed as the first division chief (1976-1988). Along with Dr. James Yao, Dr. Bergan established one of the earliest clinical vascular fellowship programs in 1976 at Northwestern. This fellowship program was the genesis for many future leaders of vascular surgery. In 1989, Dr. Bergan left Northwestern for southern California where he concentrated on developing clinical and basic research in venous disease.
Dr. Bergan was instrumental in founding and developing many new societies and publications, including Midwestern Vascular Surgical Society. He also participated in the development of many practice guidelines including a method for data retrieval using computer programming and guidelines for venous disease diagnosis and treatment. He served as president of numerous societies, including the Society for Vascular Surgery, the American Venous Forum, American Venous Forum Foundation, Midwestern Vascular Surgical Society, European-American Venous Symposium, Gulf Coast Vascular Society, Chicago Surgical Society, Lymphedema Association of North America, and Southern California Vascular Surgical Society.
In his career, he authored and co-authored more than 750 publications, including peer-reviewed journal articles, scientific reports, editorials, and book chapters, as well as editing over 35 books. He was invited to speak to professional audiences all over the world and received numerous national and international honors and awards, including the Rovsing Silver Medal from the Danish Surgical Society, Honorary Fellowship in the Royal College of Surgeons of England, and the Lifetime Achievement Award from the International Society for Endovascular Surgery.
Dr. Bergan was a world renowned leader and contributor to the field of Vascular Surgery. He was a prolific scholar, tireless investigator, eloquent speaker, and dedicated educator. When asked what was the most rewarding experience in his long, successful career, Dr. Bergan responded "to teach". We are truly grateful for all that he has contributed and he will be sorely missed.
The Memorial and Celebration of Dr. Bergan\'s life will be held on July 7, 2014, 4:00pm, at the Chicago Yacht Club - Belmont at the Lake (not the Monroe Street clubhouse). If you are able to attend, please send a note to [email protected] so that plans can be made accordingly since space may be limited.
In lieu of flowers, Dr. Bergan’s family has asked that you please make a contribution to the:
John J. Bergan, MD Lectureship
Northwestern University Feinberg School of Medicine.
Address: 420 E. Superior Street
Rubloff Building, 9th Floor
Chicago, Illinois 60611
If you would like to leave a message for Dr. Bergan’s family or share a remembrance of him, you may do so at http://www.caringbridge.org/visit/johnjbergan/guestbook.
Dr. Eskandari is The James S.T. Yao, MD, PhD Professor of Education in Vascular Surgery, chief and program director, Division of Vascular Surgery, Northwestern University Feinberg School of Medicine, Chicago.
Vascular pioneer, Dr. John J. Bergan, died on June 11th, 2014.
Dr. Bergan’s illustrious career spanned more than 50 years. He completed his residency at Chicago Wesley Memorial Hospital in 1959 and began his medical career as a clinical assistant in surgery at Northwestern University Medical School. He rose through the ranks at Northwestern and served as the chief of the Division of Transplantation at Northwestern University Medical School from 1969 to 1976. When the Division of Vascular Surgery was formed in 1976, Dr. Bergan was appointed as the first division chief (1976-1988). Along with Dr. James Yao, Dr. Bergan established one of the earliest clinical vascular fellowship programs in 1976 at Northwestern. This fellowship program was the genesis for many future leaders of vascular surgery. In 1989, Dr. Bergan left Northwestern for southern California where he concentrated on developing clinical and basic research in venous disease.
Dr. Bergan was instrumental in founding and developing many new societies and publications, including Midwestern Vascular Surgical Society. He also participated in the development of many practice guidelines including a method for data retrieval using computer programming and guidelines for venous disease diagnosis and treatment. He served as president of numerous societies, including the Society for Vascular Surgery, the American Venous Forum, American Venous Forum Foundation, Midwestern Vascular Surgical Society, European-American Venous Symposium, Gulf Coast Vascular Society, Chicago Surgical Society, Lymphedema Association of North America, and Southern California Vascular Surgical Society.
In his career, he authored and co-authored more than 750 publications, including peer-reviewed journal articles, scientific reports, editorials, and book chapters, as well as editing over 35 books. He was invited to speak to professional audiences all over the world and received numerous national and international honors and awards, including the Rovsing Silver Medal from the Danish Surgical Society, Honorary Fellowship in the Royal College of Surgeons of England, and the Lifetime Achievement Award from the International Society for Endovascular Surgery.
Dr. Bergan was a world renowned leader and contributor to the field of Vascular Surgery. He was a prolific scholar, tireless investigator, eloquent speaker, and dedicated educator. When asked what was the most rewarding experience in his long, successful career, Dr. Bergan responded "to teach". We are truly grateful for all that he has contributed and he will be sorely missed.
The Memorial and Celebration of Dr. Bergan\'s life will be held on July 7, 2014, 4:00pm, at the Chicago Yacht Club - Belmont at the Lake (not the Monroe Street clubhouse). If you are able to attend, please send a note to [email protected] so that plans can be made accordingly since space may be limited.
In lieu of flowers, Dr. Bergan’s family has asked that you please make a contribution to the:
John J. Bergan, MD Lectureship
Northwestern University Feinberg School of Medicine.
Address: 420 E. Superior Street
Rubloff Building, 9th Floor
Chicago, Illinois 60611
If you would like to leave a message for Dr. Bergan’s family or share a remembrance of him, you may do so at http://www.caringbridge.org/visit/johnjbergan/guestbook.
Dr. Eskandari is The James S.T. Yao, MD, PhD Professor of Education in Vascular Surgery, chief and program director, Division of Vascular Surgery, Northwestern University Feinberg School of Medicine, Chicago.
Vascular pioneer, Dr. John J. Bergan, died on June 11th, 2014.
Dr. Bergan’s illustrious career spanned more than 50 years. He completed his residency at Chicago Wesley Memorial Hospital in 1959 and began his medical career as a clinical assistant in surgery at Northwestern University Medical School. He rose through the ranks at Northwestern and served as the chief of the Division of Transplantation at Northwestern University Medical School from 1969 to 1976. When the Division of Vascular Surgery was formed in 1976, Dr. Bergan was appointed as the first division chief (1976-1988). Along with Dr. James Yao, Dr. Bergan established one of the earliest clinical vascular fellowship programs in 1976 at Northwestern. This fellowship program was the genesis for many future leaders of vascular surgery. In 1989, Dr. Bergan left Northwestern for southern California where he concentrated on developing clinical and basic research in venous disease.
Dr. Bergan was instrumental in founding and developing many new societies and publications, including Midwestern Vascular Surgical Society. He also participated in the development of many practice guidelines including a method for data retrieval using computer programming and guidelines for venous disease diagnosis and treatment. He served as president of numerous societies, including the Society for Vascular Surgery, the American Venous Forum, American Venous Forum Foundation, Midwestern Vascular Surgical Society, European-American Venous Symposium, Gulf Coast Vascular Society, Chicago Surgical Society, Lymphedema Association of North America, and Southern California Vascular Surgical Society.
In his career, he authored and co-authored more than 750 publications, including peer-reviewed journal articles, scientific reports, editorials, and book chapters, as well as editing over 35 books. He was invited to speak to professional audiences all over the world and received numerous national and international honors and awards, including the Rovsing Silver Medal from the Danish Surgical Society, Honorary Fellowship in the Royal College of Surgeons of England, and the Lifetime Achievement Award from the International Society for Endovascular Surgery.
Dr. Bergan was a world renowned leader and contributor to the field of Vascular Surgery. He was a prolific scholar, tireless investigator, eloquent speaker, and dedicated educator. When asked what was the most rewarding experience in his long, successful career, Dr. Bergan responded "to teach". We are truly grateful for all that he has contributed and he will be sorely missed.
The Memorial and Celebration of Dr. Bergan\'s life will be held on July 7, 2014, 4:00pm, at the Chicago Yacht Club - Belmont at the Lake (not the Monroe Street clubhouse). If you are able to attend, please send a note to [email protected] so that plans can be made accordingly since space may be limited.
In lieu of flowers, Dr. Bergan’s family has asked that you please make a contribution to the:
John J. Bergan, MD Lectureship
Northwestern University Feinberg School of Medicine.
Address: 420 E. Superior Street
Rubloff Building, 9th Floor
Chicago, Illinois 60611
If you would like to leave a message for Dr. Bergan’s family or share a remembrance of him, you may do so at http://www.caringbridge.org/visit/johnjbergan/guestbook.
Dr. Eskandari is The James S.T. Yao, MD, PhD Professor of Education in Vascular Surgery, chief and program director, Division of Vascular Surgery, Northwestern University Feinberg School of Medicine, Chicago.
Ruxolitinib improves disease control in PV
©ASCO/Phil McCarten
CHICAGO—The JAK1/2 inhibitor ruxolitinib may be a “valuable new treatment option” for patients with polycythemia vera (PV) who cannot tolerate or are resistant to hydroxyurea, according to a speaker at the 2014 ASCO Annual Meeting.
Results of the phase 3 RESPONSE trial showed that ruxolitinib can reduce spleen size in these patients and improve hematocrit control without the need for phlebotomy.
And the drug was generally well-tolerated.
“Patients with PV may not have their disease controlled with existing therapies, increasing their risk for cardiovascular complications,” said Srdan Verstovsek, MD, PhD, of MD Anderson Cancer Center in Houston, Texas.
“In the RESPONSE trial, patients treated with ruxolitinib showed better disease control and improved symptom management compared to [patients who received] current therapies.”
Dr Verstovsek presented results from the trial at ASCO as abstract 7026. RESPONSE was funded by Incyte Corporation, the company developing ruxolitinib.
The study has enrolled 222 patients with PV that is resistant to or intolerant of hydroxyurea. Patients were randomized to receive either ruxolitinib at a starting dose of 10 mg twice-daily or best available therapy (BAT). The ruxolitinib dose was adjusted as needed throughout the study.
At week 32, 77% of patients on ruxolitinib and 20% on BAT achieved hematocrit control or spleen reduction.
The primary endpoint of the study was the proportion of patients whose hematocrit was controlled without phlebotomy from week 8 through 32 and whose spleen volume was reduced by 35% or more from baseline as assessed by imaging at 32 weeks.
Twenty-one percent of patients in the ruxolitinib arm achieved this endpoint, compared to 1% of patients in the BAT arm.
“Ninety-one percent of patients who achieved the primary end point had a confirmed response at 48 weeks,” Dr Verstovsek said.
He also noted that nearly half of ruxolitinib-treated patients had a 50% or greater reduction in debilitating PV symptoms, compared to 5% of those on BAT.
Patients treated with ruxolitinib also experienced a reduction in night sweats and itchiness. In addition, a greater proportion of patients in the ruxolitinib arm achieved complete hematologic response when compared to the BAT arm—24% and 9%, respectively.
Ruxolitinib was generally well-tolerated, Dr Verstovsek said, noting that 85% of patients were still receiving the drug at a median follow-up of 81 weeks.
However, 3.6% of patients on ruxolitinib discontinued treatment due to adverse events, compared to 1.8% of patients on BAT.
Most adverse events observed in the ruxolitinib arm were grade 1 or 2 and were consistent with those previously seen in ruxolitinib studies in PV and myelofibrosis.
Few patients developed grade 3 or 4 cytopenias. Within the first 32 weeks of treatment, grade 3 or 4 hematologic adverse events in the ruxolitinib treatment arm were anemia (1.8%) and thrombocytopenia (5.5%). Fewer patients treated with ruxolitinib experienced thromboembolic events when compared to those who received BAT.
The most common non-hematologic adverse events were headache, diarrhea, and fatigue, which were mainly grade 1 or 2. Dr Verstovsek noted that herpes zoster infection was higher in the ruxolitinib arm than in the BAT arm.
Ruxolitinib is currently approved in more than 60 countries for patients with myelofibrosis. Global regulatory filings for PV are underway based on the RESPONSE data. 
©ASCO/Phil McCarten
CHICAGO—The JAK1/2 inhibitor ruxolitinib may be a “valuable new treatment option” for patients with polycythemia vera (PV) who cannot tolerate or are resistant to hydroxyurea, according to a speaker at the 2014 ASCO Annual Meeting.
Results of the phase 3 RESPONSE trial showed that ruxolitinib can reduce spleen size in these patients and improve hematocrit control without the need for phlebotomy.
And the drug was generally well-tolerated.
“Patients with PV may not have their disease controlled with existing therapies, increasing their risk for cardiovascular complications,” said Srdan Verstovsek, MD, PhD, of MD Anderson Cancer Center in Houston, Texas.
“In the RESPONSE trial, patients treated with ruxolitinib showed better disease control and improved symptom management compared to [patients who received] current therapies.”
Dr Verstovsek presented results from the trial at ASCO as abstract 7026. RESPONSE was funded by Incyte Corporation, the company developing ruxolitinib.
The study has enrolled 222 patients with PV that is resistant to or intolerant of hydroxyurea. Patients were randomized to receive either ruxolitinib at a starting dose of 10 mg twice-daily or best available therapy (BAT). The ruxolitinib dose was adjusted as needed throughout the study.
At week 32, 77% of patients on ruxolitinib and 20% on BAT achieved hematocrit control or spleen reduction.
The primary endpoint of the study was the proportion of patients whose hematocrit was controlled without phlebotomy from week 8 through 32 and whose spleen volume was reduced by 35% or more from baseline as assessed by imaging at 32 weeks.
Twenty-one percent of patients in the ruxolitinib arm achieved this endpoint, compared to 1% of patients in the BAT arm.
“Ninety-one percent of patients who achieved the primary end point had a confirmed response at 48 weeks,” Dr Verstovsek said.
He also noted that nearly half of ruxolitinib-treated patients had a 50% or greater reduction in debilitating PV symptoms, compared to 5% of those on BAT.
Patients treated with ruxolitinib also experienced a reduction in night sweats and itchiness. In addition, a greater proportion of patients in the ruxolitinib arm achieved complete hematologic response when compared to the BAT arm—24% and 9%, respectively.
Ruxolitinib was generally well-tolerated, Dr Verstovsek said, noting that 85% of patients were still receiving the drug at a median follow-up of 81 weeks.
However, 3.6% of patients on ruxolitinib discontinued treatment due to adverse events, compared to 1.8% of patients on BAT.
Most adverse events observed in the ruxolitinib arm were grade 1 or 2 and were consistent with those previously seen in ruxolitinib studies in PV and myelofibrosis.
Few patients developed grade 3 or 4 cytopenias. Within the first 32 weeks of treatment, grade 3 or 4 hematologic adverse events in the ruxolitinib treatment arm were anemia (1.8%) and thrombocytopenia (5.5%). Fewer patients treated with ruxolitinib experienced thromboembolic events when compared to those who received BAT.
The most common non-hematologic adverse events were headache, diarrhea, and fatigue, which were mainly grade 1 or 2. Dr Verstovsek noted that herpes zoster infection was higher in the ruxolitinib arm than in the BAT arm.
Ruxolitinib is currently approved in more than 60 countries for patients with myelofibrosis. Global regulatory filings for PV are underway based on the RESPONSE data.
©ASCO/Phil McCarten
CHICAGO—The JAK1/2 inhibitor ruxolitinib may be a “valuable new treatment option” for patients with polycythemia vera (PV) who cannot tolerate or are resistant to hydroxyurea, according to a speaker at the 2014 ASCO Annual Meeting.
Results of the phase 3 RESPONSE trial showed that ruxolitinib can reduce spleen size in these patients and improve hematocrit control without the need for phlebotomy.
And the drug was generally well-tolerated.
“Patients with PV may not have their disease controlled with existing therapies, increasing their risk for cardiovascular complications,” said Srdan Verstovsek, MD, PhD, of MD Anderson Cancer Center in Houston, Texas.
“In the RESPONSE trial, patients treated with ruxolitinib showed better disease control and improved symptom management compared to [patients who received] current therapies.”
Dr Verstovsek presented results from the trial at ASCO as abstract 7026. RESPONSE was funded by Incyte Corporation, the company developing ruxolitinib.
The study has enrolled 222 patients with PV that is resistant to or intolerant of hydroxyurea. Patients were randomized to receive either ruxolitinib at a starting dose of 10 mg twice-daily or best available therapy (BAT). The ruxolitinib dose was adjusted as needed throughout the study.
At week 32, 77% of patients on ruxolitinib and 20% on BAT achieved hematocrit control or spleen reduction.
The primary endpoint of the study was the proportion of patients whose hematocrit was controlled without phlebotomy from week 8 through 32 and whose spleen volume was reduced by 35% or more from baseline as assessed by imaging at 32 weeks.
Twenty-one percent of patients in the ruxolitinib arm achieved this endpoint, compared to 1% of patients in the BAT arm.
“Ninety-one percent of patients who achieved the primary end point had a confirmed response at 48 weeks,” Dr Verstovsek said.
He also noted that nearly half of ruxolitinib-treated patients had a 50% or greater reduction in debilitating PV symptoms, compared to 5% of those on BAT.
Patients treated with ruxolitinib also experienced a reduction in night sweats and itchiness. In addition, a greater proportion of patients in the ruxolitinib arm achieved complete hematologic response when compared to the BAT arm—24% and 9%, respectively.
Ruxolitinib was generally well-tolerated, Dr Verstovsek said, noting that 85% of patients were still receiving the drug at a median follow-up of 81 weeks.
However, 3.6% of patients on ruxolitinib discontinued treatment due to adverse events, compared to 1.8% of patients on BAT.
Most adverse events observed in the ruxolitinib arm were grade 1 or 2 and were consistent with those previously seen in ruxolitinib studies in PV and myelofibrosis.
Few patients developed grade 3 or 4 cytopenias. Within the first 32 weeks of treatment, grade 3 or 4 hematologic adverse events in the ruxolitinib treatment arm were anemia (1.8%) and thrombocytopenia (5.5%). Fewer patients treated with ruxolitinib experienced thromboembolic events when compared to those who received BAT.
The most common non-hematologic adverse events were headache, diarrhea, and fatigue, which were mainly grade 1 or 2. Dr Verstovsek noted that herpes zoster infection was higher in the ruxolitinib arm than in the BAT arm.
Ruxolitinib is currently approved in more than 60 countries for patients with myelofibrosis. Global regulatory filings for PV are underway based on the RESPONSE data.
Treating HIV+ lymphoma patients
©ASCO/Brian Powers
CHICAGO—Hepatitis C reactivation does not worsen survival outcomes for HIV-positive patients diagnosed with lymphoma, new research indicates.
The study showed these patients can tolerate chemotherapy without adverse outcomes and are therefore eligible for aggressive treatment.
They should be closely monitored, however, according to study investigator Stefan K. Barta, MD, of Fox Chase Cancer Center in Philadelphia, Pennsylvania.
Dr Barta and his colleagues presented results observed in HIV-positive lymphoma patients at the 2014 ASCO Annual Meeting as abstract 8578.
The team noted that more than a quarter of HIV-positive patients are also infected with the hepatitis C virus (HCV), which may complicate treatment and care decisions after a cancer diagnosis.
“Patients undergoing chemotherapy can experience reactivation of the hepatitis C virus, which, in turn, can lead to liver failure,” Dr Barta said. “This means we have to dose-reduce chemotherapy, which could negatively affect outcomes.”
In addition, HIV-positive patients often take a host of other medications, including anti-retrovirals, which makes them especially vulnerable to side effects.
However, Dr Barta said these potential risks shouldn’t deter oncologists from treating these patients with chemotherapy because he and his colleagues found that reactivation of HCV did not worsen survival outcomes in this population.
The researchers analyzed the medical records of 190 HIV-positive patients who had been diagnosed with lymphoma at the Albert Einstein Cancer Center in Bronx, New York, from 1997 to 2013. Patients with primary central nervous system lymphomas were excluded.
Fifty-three (28%) eligible patients were also infected with HCV. The virus reactivated in 17 of those patients, or about one-third of the patient population infected with HCV, during treatment.
Patients infected with HCV had an overall survival of 59.7 months, compared to 88.6 months for patients with neither HCV nor hepatitis B virus (HBV).
However, that survival advantage vanished when the researchers adjusted for variables including age, sex, race, CD4 count, the presence of cirrhosis, type of lymphoma, and levels of lactate dehydrogenase (LDH).
The multivariate analysis showed that co-infection with HCV was not associated with lower overall survival in lymphoma patients.
At the same time, the researchers did find worse overall survival outcomes associated with low CD4 count (below 100 cells/cubic millimeter), a diagnosis of non-Hodgkin lymphoma, advanced stage disease, LDH levels over 190, or cirrhosis.
Dr Barta said he hopes this research will open cancer trials up to an understudied patient population. HIV-positive patients with HCV are often excluded from these trials because of concerns about liver failure and toxicity arising from the interaction of retroviral medications with chemotherapy.
“This is really important for a large proportion of patients,” he said. “We want to assure researchers that these patients, as long as they have adequate liver function, should also be enrolled in clinical trials.”
©ASCO/Brian Powers
CHICAGO—Hepatitis C reactivation does not worsen survival outcomes for HIV-positive patients diagnosed with lymphoma, new research indicates.
The study showed these patients can tolerate chemotherapy without adverse outcomes and are therefore eligible for aggressive treatment.
They should be closely monitored, however, according to study investigator Stefan K. Barta, MD, of Fox Chase Cancer Center in Philadelphia, Pennsylvania.
Dr Barta and his colleagues presented results observed in HIV-positive lymphoma patients at the 2014 ASCO Annual Meeting as abstract 8578.
The team noted that more than a quarter of HIV-positive patients are also infected with the hepatitis C virus (HCV), which may complicate treatment and care decisions after a cancer diagnosis.
“Patients undergoing chemotherapy can experience reactivation of the hepatitis C virus, which, in turn, can lead to liver failure,” Dr Barta said. “This means we have to dose-reduce chemotherapy, which could negatively affect outcomes.”
In addition, HIV-positive patients often take a host of other medications, including anti-retrovirals, which makes them especially vulnerable to side effects.
However, Dr Barta said these potential risks shouldn’t deter oncologists from treating these patients with chemotherapy because he and his colleagues found that reactivation of HCV did not worsen survival outcomes in this population.
The researchers analyzed the medical records of 190 HIV-positive patients who had been diagnosed with lymphoma at the Albert Einstein Cancer Center in Bronx, New York, from 1997 to 2013. Patients with primary central nervous system lymphomas were excluded.
Fifty-three (28%) eligible patients were also infected with HCV. The virus reactivated in 17 of those patients, or about one-third of the patient population infected with HCV, during treatment.
Patients infected with HCV had an overall survival of 59.7 months, compared to 88.6 months for patients with neither HCV nor hepatitis B virus (HBV).
However, that survival advantage vanished when the researchers adjusted for variables including age, sex, race, CD4 count, the presence of cirrhosis, type of lymphoma, and levels of lactate dehydrogenase (LDH).
The multivariate analysis showed that co-infection with HCV was not associated with lower overall survival in lymphoma patients.
At the same time, the researchers did find worse overall survival outcomes associated with low CD4 count (below 100 cells/cubic millimeter), a diagnosis of non-Hodgkin lymphoma, advanced stage disease, LDH levels over 190, or cirrhosis.
Dr Barta said he hopes this research will open cancer trials up to an understudied patient population. HIV-positive patients with HCV are often excluded from these trials because of concerns about liver failure and toxicity arising from the interaction of retroviral medications with chemotherapy.
“This is really important for a large proportion of patients,” he said. “We want to assure researchers that these patients, as long as they have adequate liver function, should also be enrolled in clinical trials.”
©ASCO/Brian Powers
CHICAGO—Hepatitis C reactivation does not worsen survival outcomes for HIV-positive patients diagnosed with lymphoma, new research indicates.
The study showed these patients can tolerate chemotherapy without adverse outcomes and are therefore eligible for aggressive treatment.
They should be closely monitored, however, according to study investigator Stefan K. Barta, MD, of Fox Chase Cancer Center in Philadelphia, Pennsylvania.
Dr Barta and his colleagues presented results observed in HIV-positive lymphoma patients at the 2014 ASCO Annual Meeting as abstract 8578.
The team noted that more than a quarter of HIV-positive patients are also infected with the hepatitis C virus (HCV), which may complicate treatment and care decisions after a cancer diagnosis.
“Patients undergoing chemotherapy can experience reactivation of the hepatitis C virus, which, in turn, can lead to liver failure,” Dr Barta said. “This means we have to dose-reduce chemotherapy, which could negatively affect outcomes.”
In addition, HIV-positive patients often take a host of other medications, including anti-retrovirals, which makes them especially vulnerable to side effects.
However, Dr Barta said these potential risks shouldn’t deter oncologists from treating these patients with chemotherapy because he and his colleagues found that reactivation of HCV did not worsen survival outcomes in this population.
The researchers analyzed the medical records of 190 HIV-positive patients who had been diagnosed with lymphoma at the Albert Einstein Cancer Center in Bronx, New York, from 1997 to 2013. Patients with primary central nervous system lymphomas were excluded.
Fifty-three (28%) eligible patients were also infected with HCV. The virus reactivated in 17 of those patients, or about one-third of the patient population infected with HCV, during treatment.
Patients infected with HCV had an overall survival of 59.7 months, compared to 88.6 months for patients with neither HCV nor hepatitis B virus (HBV).
However, that survival advantage vanished when the researchers adjusted for variables including age, sex, race, CD4 count, the presence of cirrhosis, type of lymphoma, and levels of lactate dehydrogenase (LDH).
The multivariate analysis showed that co-infection with HCV was not associated with lower overall survival in lymphoma patients.
At the same time, the researchers did find worse overall survival outcomes associated with low CD4 count (below 100 cells/cubic millimeter), a diagnosis of non-Hodgkin lymphoma, advanced stage disease, LDH levels over 190, or cirrhosis.
Dr Barta said he hopes this research will open cancer trials up to an understudied patient population. HIV-positive patients with HCV are often excluded from these trials because of concerns about liver failure and toxicity arising from the interaction of retroviral medications with chemotherapy.
“This is really important for a large proportion of patients,” he said. “We want to assure researchers that these patients, as long as they have adequate liver function, should also be enrolled in clinical trials.”
FDA warns of VTE related to testosterone products
Credit: Kevin MacKenzie
The US Food and Drug Administration (FDA) is taking additional action to warn the public about the risk of venous thromboembolism (VTE) associated with the use of testosterone products.
The agency is now requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of VTE these products pose.
The risk is already included in the labeling as a possible consequence of polycythemia, which sometimes occurs with testosterone treatment.
But there have been post-market reports of VTE unrelated to polycythemia.
So the FDA has mandated the label change to provide a more general warning and ensure the risk of VTE is described consistently in the labeling of all approved testosterone products.
This new warning is not related to FDA’s ongoing evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products.
The agency is currently evaluating the potential risk of these events, which are described in the Drug Safety Communication posted on January 31, 2014.
Testosterone products are FDA-approved for use in men who lack testosterone or have low testosterone levels in conjunction with an associated medical condition.
The FDA is asking healthcare professionals and consumers to report any adverse reactions related to testosterone products to the agency’s MedWatch Safety Information and Adverse Event Reporting program.
Credit: Kevin MacKenzie
The US Food and Drug Administration (FDA) is taking additional action to warn the public about the risk of venous thromboembolism (VTE) associated with the use of testosterone products.
The agency is now requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of VTE these products pose.
The risk is already included in the labeling as a possible consequence of polycythemia, which sometimes occurs with testosterone treatment.
But there have been post-market reports of VTE unrelated to polycythemia.
So the FDA has mandated the label change to provide a more general warning and ensure the risk of VTE is described consistently in the labeling of all approved testosterone products.
This new warning is not related to FDA’s ongoing evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products.
The agency is currently evaluating the potential risk of these events, which are described in the Drug Safety Communication posted on January 31, 2014.
Testosterone products are FDA-approved for use in men who lack testosterone or have low testosterone levels in conjunction with an associated medical condition.
The FDA is asking healthcare professionals and consumers to report any adverse reactions related to testosterone products to the agency’s MedWatch Safety Information and Adverse Event Reporting program.
Credit: Kevin MacKenzie
The US Food and Drug Administration (FDA) is taking additional action to warn the public about the risk of venous thromboembolism (VTE) associated with the use of testosterone products.
The agency is now requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of VTE these products pose.
The risk is already included in the labeling as a possible consequence of polycythemia, which sometimes occurs with testosterone treatment.
But there have been post-market reports of VTE unrelated to polycythemia.
So the FDA has mandated the label change to provide a more general warning and ensure the risk of VTE is described consistently in the labeling of all approved testosterone products.
This new warning is not related to FDA’s ongoing evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products.
The agency is currently evaluating the potential risk of these events, which are described in the Drug Safety Communication posted on January 31, 2014.
Testosterone products are FDA-approved for use in men who lack testosterone or have low testosterone levels in conjunction with an associated medical condition.
The FDA is asking healthcare professionals and consumers to report any adverse reactions related to testosterone products to the agency’s MedWatch Safety Information and Adverse Event Reporting program.
Lipid instigates leukemic cell death
Scientists say they’ve identified a tumor-associated lipid that successfully stimulates T cells to kill leukemia cells in vitro and in vivo.
The team noted that certain T cells can recognize the presentation of self-derived lipids on the CD1c protein.
These T cells are commonly found in healthy individuals and are known to kill transformed hematopoietic cells.
However, their antigen specificity and potential antileukemic effects have not been well characterized.
So Gennaro De Libero, MD, PhD, of the University Hospital Basel in Switzerland, and his colleagues analyzed these cells and reported their findings in The Journal of Experimental Medicine.
The researchers discovered that CD1c self-reactive T cells recognize a novel class of self-lipids called methyl-lysophosphatidic acids (mLPAs), which were abundant in several human leukemias.
These mLPAs are the first example of lipid tumor-associated antigens (TAAs). TAAs are produced by tumors and stimulate T cells that can kill leukemia cells.
However, protein TAA accumulation can be drastically reduced by variant leukemia cells. And some TAAs may change their structure, which prevents recognition by T cells and facilitates tumor evasion.
mLPAs, on the other hand, do not change their structure and remain abundant in leukemia cells.
Furthermore, Dr De Libero and his colleagues found they could isolate the T cells that recognize and kill mLPA-expressing leukemia cells in in vitro tests.
And when the team transplanted the T cells into mice, the cells displayed therapeutic efficacy against leukemia cells.
The researchers noted that this type of immunotherapy, if proven effective in humans, could be used to help prevent leukemia relapse after chemotherapy or stem cell transplant.
Scientists say they’ve identified a tumor-associated lipid that successfully stimulates T cells to kill leukemia cells in vitro and in vivo.
The team noted that certain T cells can recognize the presentation of self-derived lipids on the CD1c protein.
These T cells are commonly found in healthy individuals and are known to kill transformed hematopoietic cells.
However, their antigen specificity and potential antileukemic effects have not been well characterized.
So Gennaro De Libero, MD, PhD, of the University Hospital Basel in Switzerland, and his colleagues analyzed these cells and reported their findings in The Journal of Experimental Medicine.
The researchers discovered that CD1c self-reactive T cells recognize a novel class of self-lipids called methyl-lysophosphatidic acids (mLPAs), which were abundant in several human leukemias.
These mLPAs are the first example of lipid tumor-associated antigens (TAAs). TAAs are produced by tumors and stimulate T cells that can kill leukemia cells.
However, protein TAA accumulation can be drastically reduced by variant leukemia cells. And some TAAs may change their structure, which prevents recognition by T cells and facilitates tumor evasion.
mLPAs, on the other hand, do not change their structure and remain abundant in leukemia cells.
Furthermore, Dr De Libero and his colleagues found they could isolate the T cells that recognize and kill mLPA-expressing leukemia cells in in vitro tests.
And when the team transplanted the T cells into mice, the cells displayed therapeutic efficacy against leukemia cells.
The researchers noted that this type of immunotherapy, if proven effective in humans, could be used to help prevent leukemia relapse after chemotherapy or stem cell transplant.
Scientists say they’ve identified a tumor-associated lipid that successfully stimulates T cells to kill leukemia cells in vitro and in vivo.
The team noted that certain T cells can recognize the presentation of self-derived lipids on the CD1c protein.
These T cells are commonly found in healthy individuals and are known to kill transformed hematopoietic cells.
However, their antigen specificity and potential antileukemic effects have not been well characterized.
So Gennaro De Libero, MD, PhD, of the University Hospital Basel in Switzerland, and his colleagues analyzed these cells and reported their findings in The Journal of Experimental Medicine.
The researchers discovered that CD1c self-reactive T cells recognize a novel class of self-lipids called methyl-lysophosphatidic acids (mLPAs), which were abundant in several human leukemias.
These mLPAs are the first example of lipid tumor-associated antigens (TAAs). TAAs are produced by tumors and stimulate T cells that can kill leukemia cells.
However, protein TAA accumulation can be drastically reduced by variant leukemia cells. And some TAAs may change their structure, which prevents recognition by T cells and facilitates tumor evasion.
mLPAs, on the other hand, do not change their structure and remain abundant in leukemia cells.
Furthermore, Dr De Libero and his colleagues found they could isolate the T cells that recognize and kill mLPA-expressing leukemia cells in in vitro tests.
And when the team transplanted the T cells into mice, the cells displayed therapeutic efficacy against leukemia cells.
The researchers noted that this type of immunotherapy, if proven effective in humans, could be used to help prevent leukemia relapse after chemotherapy or stem cell transplant.
Later-life PTSD boosts vascular risk, study finds
ORLANDO – Military veterans aged 55 years or older with current posttraumatic stress disorder are at significantly higher risk of developing new-onset vascular disease than are those without PTSD, according to a very large national longitudinal study.
"This study suggests the need for greater monitoring and treatment of PTSD in older veterans to assist in the prevention of vascular disorders," Amy L. Byers, Ph.D., said at the annual meeting of the American Association for Geriatric Psychiatry.
She reported on 138,341 veterans aged 55 years or older who were free of known vascular disease at baseline. During 8 years of follow-up, those with PTSD had significantly higher rates of incident cerebrovascular disease, acute MI, heart failure, and peripheral vascular disease than did those without PTSD, even after adjustment for demographics, comorbid diabetes, hypertension, cancer, chronic obstructive pulmonary disease, renal disease, traumatic brain injury, dementia, substance use disorders, and psychiatric diagnoses. The fully adjusted increased risk of each of the forms of vascular disease under study still remained significant at P less than .001, noted Dr. Byers, an epidemiologist in the psychiatry department at the University of California, San Francisco.
In a separate study led by Dr. Byers, PTSD in the general population with onset prior to and persistence beyond age 55 was a powerful independent predictor of global disability.
Dr. Byers’ study of older veterans was funded by the Department of Defense. She had no disclosures.
This paper continues to strengthen a link between PTSD and inflammatory markers. Dewleen Baker of the VA health care system in San Diego reported that there was a 10-fold increase in C-reactive protein (CRP) post deployment as compared with these same soldiers predeployment CRP levels. After adjustment for battlefield experience scores and combat exposures, those patients with PTSD symptoms had elevated CRP levels of 1.0 ng/mL versus 0.7 ng/mL without postdeployment symptoms (JAMA Psychiatry. 2014;71:423-31). So it seems that there may be a link between PTSD negative cardiovascular outcomes. And there may be a link between PTSD and elevated CRP. So, this leaves us with at least two questions: Is elevated CRP related to increased incidence of negative cardiovascular outcomes? And, which came first, the chicken (PTSD) or the egg (elevated CRP)?
Dr. Mark A. Adelman is chief of vascular and endovascular surgery at NYU Langone Medical Center, New York, and an associate medical editor for Vascular Specialist.
This paper continues to strengthen a link between PTSD and inflammatory markers. Dewleen Baker of the VA health care system in San Diego reported that there was a 10-fold increase in C-reactive protein (CRP) post deployment as compared with these same soldiers predeployment CRP levels. After adjustment for battlefield experience scores and combat exposures, those patients with PTSD symptoms had elevated CRP levels of 1.0 ng/mL versus 0.7 ng/mL without postdeployment symptoms (JAMA Psychiatry. 2014;71:423-31). So it seems that there may be a link between PTSD negative cardiovascular outcomes. And there may be a link between PTSD and elevated CRP. So, this leaves us with at least two questions: Is elevated CRP related to increased incidence of negative cardiovascular outcomes? And, which came first, the chicken (PTSD) or the egg (elevated CRP)?
Dr. Mark A. Adelman is chief of vascular and endovascular surgery at NYU Langone Medical Center, New York, and an associate medical editor for Vascular Specialist.
This paper continues to strengthen a link between PTSD and inflammatory markers. Dewleen Baker of the VA health care system in San Diego reported that there was a 10-fold increase in C-reactive protein (CRP) post deployment as compared with these same soldiers predeployment CRP levels. After adjustment for battlefield experience scores and combat exposures, those patients with PTSD symptoms had elevated CRP levels of 1.0 ng/mL versus 0.7 ng/mL without postdeployment symptoms (JAMA Psychiatry. 2014;71:423-31). So it seems that there may be a link between PTSD negative cardiovascular outcomes. And there may be a link between PTSD and elevated CRP. So, this leaves us with at least two questions: Is elevated CRP related to increased incidence of negative cardiovascular outcomes? And, which came first, the chicken (PTSD) or the egg (elevated CRP)?
Dr. Mark A. Adelman is chief of vascular and endovascular surgery at NYU Langone Medical Center, New York, and an associate medical editor for Vascular Specialist.
ORLANDO – Military veterans aged 55 years or older with current posttraumatic stress disorder are at significantly higher risk of developing new-onset vascular disease than are those without PTSD, according to a very large national longitudinal study.
"This study suggests the need for greater monitoring and treatment of PTSD in older veterans to assist in the prevention of vascular disorders," Amy L. Byers, Ph.D., said at the annual meeting of the American Association for Geriatric Psychiatry.
She reported on 138,341 veterans aged 55 years or older who were free of known vascular disease at baseline. During 8 years of follow-up, those with PTSD had significantly higher rates of incident cerebrovascular disease, acute MI, heart failure, and peripheral vascular disease than did those without PTSD, even after adjustment for demographics, comorbid diabetes, hypertension, cancer, chronic obstructive pulmonary disease, renal disease, traumatic brain injury, dementia, substance use disorders, and psychiatric diagnoses. The fully adjusted increased risk of each of the forms of vascular disease under study still remained significant at P less than .001, noted Dr. Byers, an epidemiologist in the psychiatry department at the University of California, San Francisco.
In a separate study led by Dr. Byers, PTSD in the general population with onset prior to and persistence beyond age 55 was a powerful independent predictor of global disability.
Dr. Byers’ study of older veterans was funded by the Department of Defense. She had no disclosures.
ORLANDO – Military veterans aged 55 years or older with current posttraumatic stress disorder are at significantly higher risk of developing new-onset vascular disease than are those without PTSD, according to a very large national longitudinal study.
"This study suggests the need for greater monitoring and treatment of PTSD in older veterans to assist in the prevention of vascular disorders," Amy L. Byers, Ph.D., said at the annual meeting of the American Association for Geriatric Psychiatry.
She reported on 138,341 veterans aged 55 years or older who were free of known vascular disease at baseline. During 8 years of follow-up, those with PTSD had significantly higher rates of incident cerebrovascular disease, acute MI, heart failure, and peripheral vascular disease than did those without PTSD, even after adjustment for demographics, comorbid diabetes, hypertension, cancer, chronic obstructive pulmonary disease, renal disease, traumatic brain injury, dementia, substance use disorders, and psychiatric diagnoses. The fully adjusted increased risk of each of the forms of vascular disease under study still remained significant at P less than .001, noted Dr. Byers, an epidemiologist in the psychiatry department at the University of California, San Francisco.
In a separate study led by Dr. Byers, PTSD in the general population with onset prior to and persistence beyond age 55 was a powerful independent predictor of global disability.
Dr. Byers’ study of older veterans was funded by the Department of Defense. She had no disclosures.
Major finding: Military veterans with late-life posttraumatic stress disorder were 80% more likely to develop new-onset cerebrovascular disease during 8 years of follow-up than were those without PTSD. They were also 82% more likely to have a first acute myocardial infarction, 56% more likely to develop heart failure, and 60% more likely to be diagnosed with peripheral vascular disease.
Data source: This was a longitudinal observational study in 138,341 veterans aged 55 years or older who were free of known vascular disease at baseline and were followed for 8 years.
Disclosures: Dr. Byers’ study of older veterans was funded by the Department of Defense. She reported having no financial conflicts.
Another surgeon’s error – Must you tell the patient?
YES: Surgeons have a duty to tell patients when a medical error has been made by a physician colleague.
Surgeons have a moral and ethical obligation to inform a patient when a medical error has occurred, including cases when the error was made by another surgeon.
Principles that support complete and honest disclosure to the patient and/or the patient’s family in such cases include professional obligation on the part of both the surgeon who made the error and the surgeon who discovered the error, the integrity of both surgeons, the patient’s right to informed care throughout the continuum of care, and the patient’s right to informed consent.
With respect to the first, the American Medical Association’s code of ethics provides a framework for disclosure; it clearly states that situations occur in which a patient experiences significant complications that may have resulted from a physician’s mistake or judgment and that the physician is ethically required to inform the patient of all facts necessary to ensure understanding of the error that occurred.
The American College of Physicians’ ethics manual also states that physicians should disclose to patients information about procedural or judgment errors made during the course of care, as long as that information is pertinent and material to the patient’s well-being.
Errors do not necessarily imply negligence or unethical behavior, but failure to disclose may.
As for patients’ rights, I think that patients are entitled to honest information. They shouldn’t bear the burden of determining how they came to be in another surgeon’s care.
Patients with complications may have impactful financial burdens that result from the additional treatment that is needed, and without all pertinent information, they may have difficulty understanding the benefits, such as deferment of payments, to which they are entitled.
The patient must also be kept informed as to the long-term care plan, and honest and timely disclosure will facilitate moving beyond blame and toward patient advocacy.
The patient is entitled to informed consent, and this requires an understanding of the conditions under which they arrived in another surgeon’s care. If a second procedure is required, the patient must be made aware of potential complications – including how the effects of the initial error might impact outcomes.
Although surgeons have an ethical obligation to disclose errors made by another surgeon, this is a difficult task. Pressures from society and medical professionals can make disclosure difficult, but the benefits of disclosure are real; studies show that open, honest communication improves patient satisfaction, strengthens the physician-patient relationship, and can improve outcomes.
Disclosure also has the potential to improve the well-being of the surgeons involved, through relieving feelings of guilt, and satisfying the need to fulfill one’s obligations. Furthermore, data suggest that error disclosure reduces long-term litigation and costs. Admittedly, however, there are little data on how disclosure of another surgeon’s errors ultimately reduces litigation and costs.
Ultimately, supporting a just culture allows us to emphasize the importance of disclosing errors and to be accountable in setting a standard that involves exploring errors rather than ignoring them; it must be remembered, though, that this process of disclosure involves obtaining facts to help both surgeons and patients understand what truly happened.
Surgeon-to-surgeon discussions can be productive and can facilitate disclosure. However, if the doctor who made the error declines to be part of the disclosure process, one still has an obligation to disclose the error and to answer the patient’s questions honestly.
This approach requires a commitment to support surgeons in their efforts to promote transparency, and it requires a clear understanding of our obligations and the role of disclosure during training; we need to engage medical students and residents.
Dr. Susan D. Moffatt-Bruce is an associate professor at the Ohio State University, Columbus.
NO: Surgeons are not required to inform a patient of another physician’s possible error.
Surgeons do not have an obligation to disclose to a patient another surgeon’s possible medical error.
A consensus has been reached in medicine about our ethical duty to inform patients about our own medical errors. Although nondisclosure has previously been rationalized by concerns about invoking anxiety or confusion in the patient, this approach has largely been discredited; disclosure preserves patient trust and bolsters the physician-patient relationship.
However, it is an entirely different story when it comes to disclosing another surgeon’s mistake – a situation that is quite common. A recent survey showed that two-thirds of respondents had encountered a similar dilemma in the past 6 months (Qual. Saf. Health Care 2009;18:209-12).
The approach that physicians have previously taken when faced with this dilemma is an important measure of what they believe represents an ethical or just response. A poll of many of my colleagues across the country and at my own institution suggests that the preferred approach is to provide appropriate care for the patient and to answer their questions honestly, but to not proactively disclose the perceived medical error.
In fact, this was the preferred approach of every surgeon who responded.
A recent article in the New England Journal of Medicine addressed this very topic. The authors noted that there is little guidance available regarding the reporting of another physician’s error (2013;369:1752-7).
Among the challenges inherent in disclosing another’s mistake is the difficulty in determining exactly what happened. Uncertainty inevitably exists regarding the conversations that took place between the patient and the surgeon, and also about what actually defines a medical error. Incidents regarded as medical errors may comprise a large spectrum, ranging from "not what I would have done – but within the standard of care," to "blatant negligence."
Several studies suggest that highly trained physicians and surgeons routinely disagree about whether negligence has occurred in a given case. In one study, two reviewers disagreed 38% of the time as to whether appropriate care was provided.
Physicians have difficulty judging if the standard of care has been met. Therefore, it is not acceptable for each of us to assume we are the medical expert capable of rendering an opinion of whether previous care was appropriate and informing patients of our opinion.
Physicians overwhelmingly report that in the event they are responsible for a medical error discovered by another physician, they would prefer that the physician come to them first to discuss the matter. In fact, 93% of 400 respondents in one survey reported this preference.
The most acceptable approach when dealing with a peer’s medical error is to discuss the error with the responsible physician and to encourage the physician to disclose any error with the patient.
If there is disagreement as to whether an error occurred, institutional guidance should be applied. Only a collaborative approach can appropriately meet the needs of the patient and family after harmful medical errors.
Dr. Chadrick E. Denlinger is an associate professor at the Medical University of South Carolina, Charleston.
YES: Surgeons have a duty to tell patients when a medical error has been made by a physician colleague.
Surgeons have a moral and ethical obligation to inform a patient when a medical error has occurred, including cases when the error was made by another surgeon.
Principles that support complete and honest disclosure to the patient and/or the patient’s family in such cases include professional obligation on the part of both the surgeon who made the error and the surgeon who discovered the error, the integrity of both surgeons, the patient’s right to informed care throughout the continuum of care, and the patient’s right to informed consent.
With respect to the first, the American Medical Association’s code of ethics provides a framework for disclosure; it clearly states that situations occur in which a patient experiences significant complications that may have resulted from a physician’s mistake or judgment and that the physician is ethically required to inform the patient of all facts necessary to ensure understanding of the error that occurred.
The American College of Physicians’ ethics manual also states that physicians should disclose to patients information about procedural or judgment errors made during the course of care, as long as that information is pertinent and material to the patient’s well-being.
Errors do not necessarily imply negligence or unethical behavior, but failure to disclose may.
As for patients’ rights, I think that patients are entitled to honest information. They shouldn’t bear the burden of determining how they came to be in another surgeon’s care.
Patients with complications may have impactful financial burdens that result from the additional treatment that is needed, and without all pertinent information, they may have difficulty understanding the benefits, such as deferment of payments, to which they are entitled.
The patient must also be kept informed as to the long-term care plan, and honest and timely disclosure will facilitate moving beyond blame and toward patient advocacy.
The patient is entitled to informed consent, and this requires an understanding of the conditions under which they arrived in another surgeon’s care. If a second procedure is required, the patient must be made aware of potential complications – including how the effects of the initial error might impact outcomes.
Although surgeons have an ethical obligation to disclose errors made by another surgeon, this is a difficult task. Pressures from society and medical professionals can make disclosure difficult, but the benefits of disclosure are real; studies show that open, honest communication improves patient satisfaction, strengthens the physician-patient relationship, and can improve outcomes.
Disclosure also has the potential to improve the well-being of the surgeons involved, through relieving feelings of guilt, and satisfying the need to fulfill one’s obligations. Furthermore, data suggest that error disclosure reduces long-term litigation and costs. Admittedly, however, there are little data on how disclosure of another surgeon’s errors ultimately reduces litigation and costs.
Ultimately, supporting a just culture allows us to emphasize the importance of disclosing errors and to be accountable in setting a standard that involves exploring errors rather than ignoring them; it must be remembered, though, that this process of disclosure involves obtaining facts to help both surgeons and patients understand what truly happened.
Surgeon-to-surgeon discussions can be productive and can facilitate disclosure. However, if the doctor who made the error declines to be part of the disclosure process, one still has an obligation to disclose the error and to answer the patient’s questions honestly.
This approach requires a commitment to support surgeons in their efforts to promote transparency, and it requires a clear understanding of our obligations and the role of disclosure during training; we need to engage medical students and residents.
Dr. Susan D. Moffatt-Bruce is an associate professor at the Ohio State University, Columbus.
NO: Surgeons are not required to inform a patient of another physician’s possible error.
Surgeons do not have an obligation to disclose to a patient another surgeon’s possible medical error.
A consensus has been reached in medicine about our ethical duty to inform patients about our own medical errors. Although nondisclosure has previously been rationalized by concerns about invoking anxiety or confusion in the patient, this approach has largely been discredited; disclosure preserves patient trust and bolsters the physician-patient relationship.
However, it is an entirely different story when it comes to disclosing another surgeon’s mistake – a situation that is quite common. A recent survey showed that two-thirds of respondents had encountered a similar dilemma in the past 6 months (Qual. Saf. Health Care 2009;18:209-12).
The approach that physicians have previously taken when faced with this dilemma is an important measure of what they believe represents an ethical or just response. A poll of many of my colleagues across the country and at my own institution suggests that the preferred approach is to provide appropriate care for the patient and to answer their questions honestly, but to not proactively disclose the perceived medical error.
In fact, this was the preferred approach of every surgeon who responded.
A recent article in the New England Journal of Medicine addressed this very topic. The authors noted that there is little guidance available regarding the reporting of another physician’s error (2013;369:1752-7).
Among the challenges inherent in disclosing another’s mistake is the difficulty in determining exactly what happened. Uncertainty inevitably exists regarding the conversations that took place between the patient and the surgeon, and also about what actually defines a medical error. Incidents regarded as medical errors may comprise a large spectrum, ranging from "not what I would have done – but within the standard of care," to "blatant negligence."
Several studies suggest that highly trained physicians and surgeons routinely disagree about whether negligence has occurred in a given case. In one study, two reviewers disagreed 38% of the time as to whether appropriate care was provided.
Physicians have difficulty judging if the standard of care has been met. Therefore, it is not acceptable for each of us to assume we are the medical expert capable of rendering an opinion of whether previous care was appropriate and informing patients of our opinion.
Physicians overwhelmingly report that in the event they are responsible for a medical error discovered by another physician, they would prefer that the physician come to them first to discuss the matter. In fact, 93% of 400 respondents in one survey reported this preference.
The most acceptable approach when dealing with a peer’s medical error is to discuss the error with the responsible physician and to encourage the physician to disclose any error with the patient.
If there is disagreement as to whether an error occurred, institutional guidance should be applied. Only a collaborative approach can appropriately meet the needs of the patient and family after harmful medical errors.
Dr. Chadrick E. Denlinger is an associate professor at the Medical University of South Carolina, Charleston.
YES: Surgeons have a duty to tell patients when a medical error has been made by a physician colleague.
Surgeons have a moral and ethical obligation to inform a patient when a medical error has occurred, including cases when the error was made by another surgeon.
Principles that support complete and honest disclosure to the patient and/or the patient’s family in such cases include professional obligation on the part of both the surgeon who made the error and the surgeon who discovered the error, the integrity of both surgeons, the patient’s right to informed care throughout the continuum of care, and the patient’s right to informed consent.
With respect to the first, the American Medical Association’s code of ethics provides a framework for disclosure; it clearly states that situations occur in which a patient experiences significant complications that may have resulted from a physician’s mistake or judgment and that the physician is ethically required to inform the patient of all facts necessary to ensure understanding of the error that occurred.
The American College of Physicians’ ethics manual also states that physicians should disclose to patients information about procedural or judgment errors made during the course of care, as long as that information is pertinent and material to the patient’s well-being.
Errors do not necessarily imply negligence or unethical behavior, but failure to disclose may.
As for patients’ rights, I think that patients are entitled to honest information. They shouldn’t bear the burden of determining how they came to be in another surgeon’s care.
Patients with complications may have impactful financial burdens that result from the additional treatment that is needed, and without all pertinent information, they may have difficulty understanding the benefits, such as deferment of payments, to which they are entitled.
The patient must also be kept informed as to the long-term care plan, and honest and timely disclosure will facilitate moving beyond blame and toward patient advocacy.
The patient is entitled to informed consent, and this requires an understanding of the conditions under which they arrived in another surgeon’s care. If a second procedure is required, the patient must be made aware of potential complications – including how the effects of the initial error might impact outcomes.
Although surgeons have an ethical obligation to disclose errors made by another surgeon, this is a difficult task. Pressures from society and medical professionals can make disclosure difficult, but the benefits of disclosure are real; studies show that open, honest communication improves patient satisfaction, strengthens the physician-patient relationship, and can improve outcomes.
Disclosure also has the potential to improve the well-being of the surgeons involved, through relieving feelings of guilt, and satisfying the need to fulfill one’s obligations. Furthermore, data suggest that error disclosure reduces long-term litigation and costs. Admittedly, however, there are little data on how disclosure of another surgeon’s errors ultimately reduces litigation and costs.
Ultimately, supporting a just culture allows us to emphasize the importance of disclosing errors and to be accountable in setting a standard that involves exploring errors rather than ignoring them; it must be remembered, though, that this process of disclosure involves obtaining facts to help both surgeons and patients understand what truly happened.
Surgeon-to-surgeon discussions can be productive and can facilitate disclosure. However, if the doctor who made the error declines to be part of the disclosure process, one still has an obligation to disclose the error and to answer the patient’s questions honestly.
This approach requires a commitment to support surgeons in their efforts to promote transparency, and it requires a clear understanding of our obligations and the role of disclosure during training; we need to engage medical students and residents.
Dr. Susan D. Moffatt-Bruce is an associate professor at the Ohio State University, Columbus.
NO: Surgeons are not required to inform a patient of another physician’s possible error.
Surgeons do not have an obligation to disclose to a patient another surgeon’s possible medical error.
A consensus has been reached in medicine about our ethical duty to inform patients about our own medical errors. Although nondisclosure has previously been rationalized by concerns about invoking anxiety or confusion in the patient, this approach has largely been discredited; disclosure preserves patient trust and bolsters the physician-patient relationship.
However, it is an entirely different story when it comes to disclosing another surgeon’s mistake – a situation that is quite common. A recent survey showed that two-thirds of respondents had encountered a similar dilemma in the past 6 months (Qual. Saf. Health Care 2009;18:209-12).
The approach that physicians have previously taken when faced with this dilemma is an important measure of what they believe represents an ethical or just response. A poll of many of my colleagues across the country and at my own institution suggests that the preferred approach is to provide appropriate care for the patient and to answer their questions honestly, but to not proactively disclose the perceived medical error.
In fact, this was the preferred approach of every surgeon who responded.
A recent article in the New England Journal of Medicine addressed this very topic. The authors noted that there is little guidance available regarding the reporting of another physician’s error (2013;369:1752-7).
Among the challenges inherent in disclosing another’s mistake is the difficulty in determining exactly what happened. Uncertainty inevitably exists regarding the conversations that took place between the patient and the surgeon, and also about what actually defines a medical error. Incidents regarded as medical errors may comprise a large spectrum, ranging from "not what I would have done – but within the standard of care," to "blatant negligence."
Several studies suggest that highly trained physicians and surgeons routinely disagree about whether negligence has occurred in a given case. In one study, two reviewers disagreed 38% of the time as to whether appropriate care was provided.
Physicians have difficulty judging if the standard of care has been met. Therefore, it is not acceptable for each of us to assume we are the medical expert capable of rendering an opinion of whether previous care was appropriate and informing patients of our opinion.
Physicians overwhelmingly report that in the event they are responsible for a medical error discovered by another physician, they would prefer that the physician come to them first to discuss the matter. In fact, 93% of 400 respondents in one survey reported this preference.
The most acceptable approach when dealing with a peer’s medical error is to discuss the error with the responsible physician and to encourage the physician to disclose any error with the patient.
If there is disagreement as to whether an error occurred, institutional guidance should be applied. Only a collaborative approach can appropriately meet the needs of the patient and family after harmful medical errors.
Dr. Chadrick E. Denlinger is an associate professor at the Medical University of South Carolina, Charleston.
Paclitaxel-eluting balloon shows high claudication efficacy
PARIS – A drug-eluting balloon produced a stentlike rate of primary patency and need for target vessel revascularization in a multinational, controlled trial with 331 patients with claudication.
The results showed that the paclitaxel-eluting angioplasty balloon used in the study, the IN.PACT model made by Medtronic, has the "potential to become the standard of care" for treating stenoses in the superficial femoral and popliteal arteries, Dr. Marianne Brodmann said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions. After 1 year, the rate of clinically driven target-vessel revascularizations was 2% in the 220 patients treated with the drug-eluting balloon and 21% in 111 control patients treated with plain balloon angioplasty, a statistically significant difference, reported Dr. Brodmann, professor of angiology at the Medical University of Graz (Austria).*
The results seen in this trial contrast with results from studies of other types of drug-eluting balloons in these arteries, said Dr. Marc Bosiers, head of the department of vascular surgery at St. Blasius Hospital in Dendermonde, Belgium, and a coinvestigator in the study. "What we’ve learned from this trial, if you look at the results from other trials [of drug-eluting balloons], is that not all drug-eluting balloons are equal, just as not all stents are equal," Dr. Bosiers said.
The IN.PACT SFA Trial enrolled 150 patients at 13 centers in Europe and 181 patients at 44 U.S. centers. All patients were adults with Rutherford stage 2, 3, or 4 disease; claudication and rest pain; and a single or closely tandem lesion in the superficial femoral or popliteal arteries with a total length of no more than 18 cm. Their average age was 68, and about 40% had diabetes. The trial protocol allowed provisional stenting, which occurred in 7% of the patients treated with a paclitaxel-eluting balloon and in 13% of those treated with a plain balloon. The average lesion length treated was about 9 cm in both arms of the study.
The study’s primary endpoint was the rate of primary patency at 12 months, defined as freedom from clinically driven target-vessel revascularization and freedom from restenosis assessed by Doppler ultrasound at 12 months, which was 82% in patients treated with the drug-eluting balloon and 52% among patients in the control arm, a statistically significant difference.
The study’s primary safety endpoint was the combined rate of procedure- and device-related death at 30 days, freedom from target-limb major amputation at 1 year, and freedom from clinically driven target-vessel revascularization at 1 year, which occurred in 96% of patients treated with the paclitaxel-eluting balloon and in 77% of the control patients, a statistically significant difference.
These outcomes included "the lowest target-vessel revascularization rates and the highest patency rates ever reported" in this setting, and provide "robust, level 1 evidence" for the safety and efficacy of the paclitaxel-eluting balloon for this indication, Dr. Brodmann concluded.
If restenosis were to occur in the target vessel following treatment with the paclitaxel-eluting balloon, it would be possible to retreat the same vessel with a second paclitaxel-eluting balloon, although that scenario was not tested in the trial, Dr. Brodmann said in an interview. The paclitaxel essentially disappears within a few months of treatment, which should allow safe retreatment.
A written statement from Medtronic said that the company has an application pending with the Food and Drug Administration for U.S. marketing approval of the IN.PACT balloon for this indication. The balloon has been available in Europe since 2009.
The IN.PACT SFA Trial was sponsored by Medtronic, which markets the IN.PACT drug-eluting balloon. Dr. Brodmann said she is a consultant to Medtronic. Dr. Bosiers said that he had no disclosures.
On Twitter @mitchelzoler
*Correction, 6/24/2014: A previous version of this article misstated the number of patients in the control arm, the number of study centers, the name of the study, and two references to the device.
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Mitchel L. Zoler/Frontline Medical News
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The results from this trial change the way we think about treating stenoses in the superficial femoral and popliteal arteries. These results are probably the first to show with such robust, level 1 evidence that a drug-eluting balloon works at least as well as the best stent available today.
The results mean that the concept of "leave nothing behind" when treating vascular disease in the superficial femoral artery will be the best approach going forward. The 82% 1-year patency rate and the 2.4% rate of clinically driven target-vessel revascularizations were absolutely outstanding results.
Dr. Alberto Cremonesi, director of the interventional cardioangiology unit at Villa Maria Cecilia Hospital in Cotignola-Ravenna, Italy, made these comments in an interview. He said he had no relevant financial disclosures.
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Mitchel L. Zoler/Frontline Medical News
|
The results from this trial change the way we think about treating stenoses in the superficial femoral and popliteal arteries. These results are probably the first to show with such robust, level 1 evidence that a drug-eluting balloon works at least as well as the best stent available today.
The results mean that the concept of "leave nothing behind" when treating vascular disease in the superficial femoral artery will be the best approach going forward. The 82% 1-year patency rate and the 2.4% rate of clinically driven target-vessel revascularizations were absolutely outstanding results.
Dr. Alberto Cremonesi, director of the interventional cardioangiology unit at Villa Maria Cecilia Hospital in Cotignola-Ravenna, Italy, made these comments in an interview. He said he had no relevant financial disclosures.
|
Mitchel L. Zoler/Frontline Medical News
|
The results from this trial change the way we think about treating stenoses in the superficial femoral and popliteal arteries. These results are probably the first to show with such robust, level 1 evidence that a drug-eluting balloon works at least as well as the best stent available today.
The results mean that the concept of "leave nothing behind" when treating vascular disease in the superficial femoral artery will be the best approach going forward. The 82% 1-year patency rate and the 2.4% rate of clinically driven target-vessel revascularizations were absolutely outstanding results.
Dr. Alberto Cremonesi, director of the interventional cardioangiology unit at Villa Maria Cecilia Hospital in Cotignola-Ravenna, Italy, made these comments in an interview. He said he had no relevant financial disclosures.
PARIS – A drug-eluting balloon produced a stentlike rate of primary patency and need for target vessel revascularization in a multinational, controlled trial with 331 patients with claudication.
The results showed that the paclitaxel-eluting angioplasty balloon used in the study, the IN.PACT model made by Medtronic, has the "potential to become the standard of care" for treating stenoses in the superficial femoral and popliteal arteries, Dr. Marianne Brodmann said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions. After 1 year, the rate of clinically driven target-vessel revascularizations was 2% in the 220 patients treated with the drug-eluting balloon and 21% in 111 control patients treated with plain balloon angioplasty, a statistically significant difference, reported Dr. Brodmann, professor of angiology at the Medical University of Graz (Austria).*
The results seen in this trial contrast with results from studies of other types of drug-eluting balloons in these arteries, said Dr. Marc Bosiers, head of the department of vascular surgery at St. Blasius Hospital in Dendermonde, Belgium, and a coinvestigator in the study. "What we’ve learned from this trial, if you look at the results from other trials [of drug-eluting balloons], is that not all drug-eluting balloons are equal, just as not all stents are equal," Dr. Bosiers said.
The IN.PACT SFA Trial enrolled 150 patients at 13 centers in Europe and 181 patients at 44 U.S. centers. All patients were adults with Rutherford stage 2, 3, or 4 disease; claudication and rest pain; and a single or closely tandem lesion in the superficial femoral or popliteal arteries with a total length of no more than 18 cm. Their average age was 68, and about 40% had diabetes. The trial protocol allowed provisional stenting, which occurred in 7% of the patients treated with a paclitaxel-eluting balloon and in 13% of those treated with a plain balloon. The average lesion length treated was about 9 cm in both arms of the study.
The study’s primary endpoint was the rate of primary patency at 12 months, defined as freedom from clinically driven target-vessel revascularization and freedom from restenosis assessed by Doppler ultrasound at 12 months, which was 82% in patients treated with the drug-eluting balloon and 52% among patients in the control arm, a statistically significant difference.
The study’s primary safety endpoint was the combined rate of procedure- and device-related death at 30 days, freedom from target-limb major amputation at 1 year, and freedom from clinically driven target-vessel revascularization at 1 year, which occurred in 96% of patients treated with the paclitaxel-eluting balloon and in 77% of the control patients, a statistically significant difference.
These outcomes included "the lowest target-vessel revascularization rates and the highest patency rates ever reported" in this setting, and provide "robust, level 1 evidence" for the safety and efficacy of the paclitaxel-eluting balloon for this indication, Dr. Brodmann concluded.
If restenosis were to occur in the target vessel following treatment with the paclitaxel-eluting balloon, it would be possible to retreat the same vessel with a second paclitaxel-eluting balloon, although that scenario was not tested in the trial, Dr. Brodmann said in an interview. The paclitaxel essentially disappears within a few months of treatment, which should allow safe retreatment.
A written statement from Medtronic said that the company has an application pending with the Food and Drug Administration for U.S. marketing approval of the IN.PACT balloon for this indication. The balloon has been available in Europe since 2009.
The IN.PACT SFA Trial was sponsored by Medtronic, which markets the IN.PACT drug-eluting balloon. Dr. Brodmann said she is a consultant to Medtronic. Dr. Bosiers said that he had no disclosures.
On Twitter @mitchelzoler
*Correction, 6/24/2014: A previous version of this article misstated the number of patients in the control arm, the number of study centers, the name of the study, and two references to the device.
PARIS – A drug-eluting balloon produced a stentlike rate of primary patency and need for target vessel revascularization in a multinational, controlled trial with 331 patients with claudication.
The results showed that the paclitaxel-eluting angioplasty balloon used in the study, the IN.PACT model made by Medtronic, has the "potential to become the standard of care" for treating stenoses in the superficial femoral and popliteal arteries, Dr. Marianne Brodmann said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions. After 1 year, the rate of clinically driven target-vessel revascularizations was 2% in the 220 patients treated with the drug-eluting balloon and 21% in 111 control patients treated with plain balloon angioplasty, a statistically significant difference, reported Dr. Brodmann, professor of angiology at the Medical University of Graz (Austria).*
The results seen in this trial contrast with results from studies of other types of drug-eluting balloons in these arteries, said Dr. Marc Bosiers, head of the department of vascular surgery at St. Blasius Hospital in Dendermonde, Belgium, and a coinvestigator in the study. "What we’ve learned from this trial, if you look at the results from other trials [of drug-eluting balloons], is that not all drug-eluting balloons are equal, just as not all stents are equal," Dr. Bosiers said.
The IN.PACT SFA Trial enrolled 150 patients at 13 centers in Europe and 181 patients at 44 U.S. centers. All patients were adults with Rutherford stage 2, 3, or 4 disease; claudication and rest pain; and a single or closely tandem lesion in the superficial femoral or popliteal arteries with a total length of no more than 18 cm. Their average age was 68, and about 40% had diabetes. The trial protocol allowed provisional stenting, which occurred in 7% of the patients treated with a paclitaxel-eluting balloon and in 13% of those treated with a plain balloon. The average lesion length treated was about 9 cm in both arms of the study.
The study’s primary endpoint was the rate of primary patency at 12 months, defined as freedom from clinically driven target-vessel revascularization and freedom from restenosis assessed by Doppler ultrasound at 12 months, which was 82% in patients treated with the drug-eluting balloon and 52% among patients in the control arm, a statistically significant difference.
The study’s primary safety endpoint was the combined rate of procedure- and device-related death at 30 days, freedom from target-limb major amputation at 1 year, and freedom from clinically driven target-vessel revascularization at 1 year, which occurred in 96% of patients treated with the paclitaxel-eluting balloon and in 77% of the control patients, a statistically significant difference.
These outcomes included "the lowest target-vessel revascularization rates and the highest patency rates ever reported" in this setting, and provide "robust, level 1 evidence" for the safety and efficacy of the paclitaxel-eluting balloon for this indication, Dr. Brodmann concluded.
If restenosis were to occur in the target vessel following treatment with the paclitaxel-eluting balloon, it would be possible to retreat the same vessel with a second paclitaxel-eluting balloon, although that scenario was not tested in the trial, Dr. Brodmann said in an interview. The paclitaxel essentially disappears within a few months of treatment, which should allow safe retreatment.
A written statement from Medtronic said that the company has an application pending with the Food and Drug Administration for U.S. marketing approval of the IN.PACT balloon for this indication. The balloon has been available in Europe since 2009.
The IN.PACT SFA Trial was sponsored by Medtronic, which markets the IN.PACT drug-eluting balloon. Dr. Brodmann said she is a consultant to Medtronic. Dr. Bosiers said that he had no disclosures.
On Twitter @mitchelzoler
*Correction, 6/24/2014: A previous version of this article misstated the number of patients in the control arm, the number of study centers, the name of the study, and two references to the device.
AT EUROPCR 2014
Key clinical point: A drug-eluting balloon produced stentlike patency after 1 year in superficial femoral and popliteal arteries.
Major finding: Angioplasty with a paclitaxel-eluting balloon produced a 1-year 82% primary patency rate, compared with 52% in controls.
Data source: A multicenter, randomized controlled trial with 331 patients with claudication and rest pain treated at 57 international sites.
Disclosures: The IN.PACT SFA Trial was sponsored by Medtronic, which markets the IN.PACT drug-eluting balloon. Dr. Brodmann said she is a consultant to Medtronic. Dr. Bosiers said he had no disclosures.
Repeat biopsy and long-term surveillance key for rare Hodgkin’s lymphoma subtype
Time to progression was inferior in patients with advanced-stage nodular lymphocyte-predominant Hodgkin’s lymphoma, compared with patients with classical Hodgkin’s lymphoma, in a study that compared outcomes between the two groups of Hodgkin’s lymphoma patients enrolled in the British Columbia Cancer Agency database.
Over 10 years, time to progression was 63% in the nodular lymphocyte-predominant Hodgkin’s lymphoma (NLPHL) group, vs. 73% in the classical Hodgkin’s lymphoma (CHL) group (P =.040), reported Dr. Katharine Xing of the Centre for Lymphoid Cancer at the BCCA and the University of British Columbia, Vancouver, and her associates.
Transformation to an aggressive non–Hodgkin’s lymphoma (NHL) over 15 years occurred in 24% of those with NLPHL, but in none of those with CHL (P = .00018), and the median time to transformation among those with NLPHL was 5.45 years (Blood 2014;123:3567-73).
The study compared 42 patients with advanced-stage NLPHL to 84 controls with advanced CHL, matched for age, sex, decade of diagnosis, stage, and chemotherapy type; all had been diagnosed between 1970 and 2011. Their mean age was 37 years, about two-thirds were men, most in both groups had stage III disease, and they were followed up for a median of about 11 years. Treatments included standard doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) and most received standard ABVD or ABVD-equivalent chemotherapy. The study was conducted to "highlight the distinct natural history of this rare HL subtype," which accounts for 5% of HL cases, the authors noted.
Over 10 years, "HL freedom from treatment failure," which reflects only relapses from HL, was 75% among those with NLPHL and 73% among those with CHL. Overall survival was also similar between the two groups (83.5% among those with NLPHL and 81% among those with CHL at 10 years).
Among their other findings was a significantly higher incidence of transformation over 10 years among those who had splenic involvement at the time of NLPHL diagnosis, compared with those who did not have splenic involvement (29% vs. 7.8%). When they looked at only those NLPHL patients who had received ABVD-like treatment, the incidence of transformation over 10 years was 34% among those with splenic involvement at diagnosis, vs. 9% among those who did not have splenic involvement (P = .014).
Since NLPHL is rare, information on the optimal treatment is limited, particularly for those with advanced disease, the authors pointed out. The analysis "highlights the distinct disease behavior of NLPHL, compared with CHL, and the need for repeat biopsy at relapse as well as long-term surveillance," the authors concluded. "Given the strong expression of CD20" on the lymphocyte predominant cells that distinguishes NLPHL from CHL, the results also provide "a rationale for further evaluation" of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) with rituximab, they added.
Time to progression was inferior in patients with advanced-stage nodular lymphocyte-predominant Hodgkin’s lymphoma, compared with patients with classical Hodgkin’s lymphoma, in a study that compared outcomes between the two groups of Hodgkin’s lymphoma patients enrolled in the British Columbia Cancer Agency database.
Over 10 years, time to progression was 63% in the nodular lymphocyte-predominant Hodgkin’s lymphoma (NLPHL) group, vs. 73% in the classical Hodgkin’s lymphoma (CHL) group (P =.040), reported Dr. Katharine Xing of the Centre for Lymphoid Cancer at the BCCA and the University of British Columbia, Vancouver, and her associates.
Transformation to an aggressive non–Hodgkin’s lymphoma (NHL) over 15 years occurred in 24% of those with NLPHL, but in none of those with CHL (P = .00018), and the median time to transformation among those with NLPHL was 5.45 years (Blood 2014;123:3567-73).
The study compared 42 patients with advanced-stage NLPHL to 84 controls with advanced CHL, matched for age, sex, decade of diagnosis, stage, and chemotherapy type; all had been diagnosed between 1970 and 2011. Their mean age was 37 years, about two-thirds were men, most in both groups had stage III disease, and they were followed up for a median of about 11 years. Treatments included standard doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) and most received standard ABVD or ABVD-equivalent chemotherapy. The study was conducted to "highlight the distinct natural history of this rare HL subtype," which accounts for 5% of HL cases, the authors noted.
Over 10 years, "HL freedom from treatment failure," which reflects only relapses from HL, was 75% among those with NLPHL and 73% among those with CHL. Overall survival was also similar between the two groups (83.5% among those with NLPHL and 81% among those with CHL at 10 years).
Among their other findings was a significantly higher incidence of transformation over 10 years among those who had splenic involvement at the time of NLPHL diagnosis, compared with those who did not have splenic involvement (29% vs. 7.8%). When they looked at only those NLPHL patients who had received ABVD-like treatment, the incidence of transformation over 10 years was 34% among those with splenic involvement at diagnosis, vs. 9% among those who did not have splenic involvement (P = .014).
Since NLPHL is rare, information on the optimal treatment is limited, particularly for those with advanced disease, the authors pointed out. The analysis "highlights the distinct disease behavior of NLPHL, compared with CHL, and the need for repeat biopsy at relapse as well as long-term surveillance," the authors concluded. "Given the strong expression of CD20" on the lymphocyte predominant cells that distinguishes NLPHL from CHL, the results also provide "a rationale for further evaluation" of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) with rituximab, they added.
Time to progression was inferior in patients with advanced-stage nodular lymphocyte-predominant Hodgkin’s lymphoma, compared with patients with classical Hodgkin’s lymphoma, in a study that compared outcomes between the two groups of Hodgkin’s lymphoma patients enrolled in the British Columbia Cancer Agency database.
Over 10 years, time to progression was 63% in the nodular lymphocyte-predominant Hodgkin’s lymphoma (NLPHL) group, vs. 73% in the classical Hodgkin’s lymphoma (CHL) group (P =.040), reported Dr. Katharine Xing of the Centre for Lymphoid Cancer at the BCCA and the University of British Columbia, Vancouver, and her associates.
Transformation to an aggressive non–Hodgkin’s lymphoma (NHL) over 15 years occurred in 24% of those with NLPHL, but in none of those with CHL (P = .00018), and the median time to transformation among those with NLPHL was 5.45 years (Blood 2014;123:3567-73).
The study compared 42 patients with advanced-stage NLPHL to 84 controls with advanced CHL, matched for age, sex, decade of diagnosis, stage, and chemotherapy type; all had been diagnosed between 1970 and 2011. Their mean age was 37 years, about two-thirds were men, most in both groups had stage III disease, and they were followed up for a median of about 11 years. Treatments included standard doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) and most received standard ABVD or ABVD-equivalent chemotherapy. The study was conducted to "highlight the distinct natural history of this rare HL subtype," which accounts for 5% of HL cases, the authors noted.
Over 10 years, "HL freedom from treatment failure," which reflects only relapses from HL, was 75% among those with NLPHL and 73% among those with CHL. Overall survival was also similar between the two groups (83.5% among those with NLPHL and 81% among those with CHL at 10 years).
Among their other findings was a significantly higher incidence of transformation over 10 years among those who had splenic involvement at the time of NLPHL diagnosis, compared with those who did not have splenic involvement (29% vs. 7.8%). When they looked at only those NLPHL patients who had received ABVD-like treatment, the incidence of transformation over 10 years was 34% among those with splenic involvement at diagnosis, vs. 9% among those who did not have splenic involvement (P = .014).
Since NLPHL is rare, information on the optimal treatment is limited, particularly for those with advanced disease, the authors pointed out. The analysis "highlights the distinct disease behavior of NLPHL, compared with CHL, and the need for repeat biopsy at relapse as well as long-term surveillance," the authors concluded. "Given the strong expression of CD20" on the lymphocyte predominant cells that distinguishes NLPHL from CHL, the results also provide "a rationale for further evaluation" of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) with rituximab, they added.
FROM BLOOD
Key clinical point: Repeat biopsy and long-term surveillance are necessary in nodular lymphocyte-predominant Hodgkin’s lymphoma.
Major finding: Overall survival was similar between patients with advanced-stage NLPHL and those with advanced-stage CHL, but differences between the two groups included an inferior time to progression among those with NLPHL over 10 years (63% vs 73%).
Data source: The study compared outcomes in 42 patients with advanced-stage NLPHL and 84 matched controls with advanced CHL, who were diagnosed between 1970 and 2011 and were enrolled in a Canadian cancer database.
Disclosures: Fourauthors received research funding from Roche; the remaining seven authors, including the lead author, had no relevant disclosures.