TBD Meeting (3909-19)

The Venous Venous Venous @VEITHsymposium program has become a popular staple of the the VEITHsymposium. Now in its 13th year, the Venous Venous Venous program, which will be held on Wednesday, Thursday, and Friday, features a mixture of didactic sessions and workshops to cover the full gamut of venous disorders and their treatments, surgical, endovascular, and medical. It is “considered to be the best and most complete program,” on venous diseases according to conference organizers.

The didactic Program I (Sessions 63-70) on Superficial Venous Disease will be held all day Thursday and will detail the latest developments in venous clinical examinations and imaging, superficial vein strategies and techniques, thermal and non-thermal ablation, and there will be a special session on venous societal issues and governance.

Moderated by Kathleen J. Ozsvath, MD, and Harold J. Welch, MD, this special program will feature discussions on the future of venous reimbursement In a non-fee for service environment, upcoming venous trials, appropriate use criteria to limit inappropriate venous care, and more.

The didactic Program L (Sessions 87-94) on Deep Venous Disease will be all day Friday and the sessions will include discussions on illiocaval stenting, wound care, and surgical and interventional management strategies for thromboembolic events in the venous system. A special medical management session will address topics including statin use, reversal agents for the DOAC, and the potential utility of e-selectin inhibition, and more.

In addition, two special non-CME workshops – “Ask the Experts” sessions – are being offered on Wednesday afternoon this year:

Module 1: Current Superficial Venous Treatment, Wounds, and Edema will focus on endothermal therapy, cyanoacrylate, MOCA, VTE and recanalization, perforators, sclerotherapy, CVI and lymphadema, lipedema, and wound care and compression.

Module 2: Thrombus Management will address thrombolysis and thrombectomy, stents, IVUS, valves, and Nutcracker syndrome.

The workshops will include video case presentations, lectures and demonstrations on vein management by experts, plus hands-on opportunities where participants can rotate through multiple training stations staffed by professionals to assist them.

The Venous Venous Venous @VEITHsymposium program has become a popular staple of the the VEITHsymposium. Now in its 13th year, the Venous Venous Venous program, which will be held on Wednesday, Thursday, and Friday, features a mixture of didactic sessions and workshops to cover the full gamut of venous disorders and their treatments, surgical, endovascular, and medical. It is “considered to be the best and most complete program,” on venous diseases according to conference organizers.

The didactic Program I (Sessions 63-70) on Superficial Venous Disease will be held all day Thursday and will detail the latest developments in venous clinical examinations and imaging, superficial vein strategies and techniques, thermal and non-thermal ablation, and there will be a special session on venous societal issues and governance.

Moderated by Kathleen J. Ozsvath, MD, and Harold J. Welch, MD, this special program will feature discussions on the future of venous reimbursement In a non-fee for service environment, upcoming venous trials, appropriate use criteria to limit inappropriate venous care, and more.

The didactic Program L (Sessions 87-94) on Deep Venous Disease will be all day Friday and the sessions will include discussions on illiocaval stenting, wound care, and surgical and interventional management strategies for thromboembolic events in the venous system. A special medical management session will address topics including statin use, reversal agents for the DOAC, and the potential utility of e-selectin inhibition, and more.

In addition, two special non-CME workshops – “Ask the Experts” sessions – are being offered on Wednesday afternoon this year:

Module 1: Current Superficial Venous Treatment, Wounds, and Edema will focus on endothermal therapy, cyanoacrylate, MOCA, VTE and recanalization, perforators, sclerotherapy, CVI and lymphadema, lipedema, and wound care and compression.

Module 2: Thrombus Management will address thrombolysis and thrombectomy, stents, IVUS, valves, and Nutcracker syndrome.

The workshops will include video case presentations, lectures and demonstrations on vein management by experts, plus hands-on opportunities where participants can rotate through multiple training stations staffed by professionals to assist them.

The Venous Venous Venous @VEITHsymposium program has become a popular staple of the the VEITHsymposium. Now in its 13th year, the Venous Venous Venous program, which will be held on Wednesday, Thursday, and Friday, features a mixture of didactic sessions and workshops to cover the full gamut of venous disorders and their treatments, surgical, endovascular, and medical. It is “considered to be the best and most complete program,” on venous diseases according to conference organizers.

The didactic Program I (Sessions 63-70) on Superficial Venous Disease will be held all day Thursday and will detail the latest developments in venous clinical examinations and imaging, superficial vein strategies and techniques, thermal and non-thermal ablation, and there will be a special session on venous societal issues and governance.

Moderated by Kathleen J. Ozsvath, MD, and Harold J. Welch, MD, this special program will feature discussions on the future of venous reimbursement In a non-fee for service environment, upcoming venous trials, appropriate use criteria to limit inappropriate venous care, and more.

The didactic Program L (Sessions 87-94) on Deep Venous Disease will be all day Friday and the sessions will include discussions on illiocaval stenting, wound care, and surgical and interventional management strategies for thromboembolic events in the venous system. A special medical management session will address topics including statin use, reversal agents for the DOAC, and the potential utility of e-selectin inhibition, and more.

In addition, two special non-CME workshops – “Ask the Experts” sessions – are being offered on Wednesday afternoon this year:

Module 1: Current Superficial Venous Treatment, Wounds, and Edema will focus on endothermal therapy, cyanoacrylate, MOCA, VTE and recanalization, perforators, sclerotherapy, CVI and lymphadema, lipedema, and wound care and compression.

Module 2: Thrombus Management will address thrombolysis and thrombectomy, stents, IVUS, valves, and Nutcracker syndrome.

The workshops will include video case presentations, lectures and demonstrations on vein management by experts, plus hands-on opportunities where participants can rotate through multiple training stations staffed by professionals to assist them.

Developments in carotid artery disease diagnosis and treatment have always been an important component of the VEITHsymposium programs and there will be sessions focusing on this critical area of patient management throughout the entire meeting.

This year, sessions will include a Tuesday focus on unresolved controversies in the management of carotid artery disease. The session will be moderated by Bruce A. Perler, MD, and L. Nelson Hopkins, MD, and include presentations on the value of using biomarkers of brain injury associated with carotid interventions, and how to assess and treat such adverse events as cerebral hyperfusion syndrome and intracranial artery dissection, as well as best medical treatments for carotid patients.

Of particular interest, there will be a debate Tuesday on the need for completion imaging with duplex or angiography with Hans-Henning Eckstein, MD, PhD, and R. Clement Darling III, MD.

Presentations will also address some of the latest treatment techniques for carotid artery disease. For example, on Wednesday morning, Norman H. Kumins, MD, of the Cleveland Medical Center, will present a study on the duration of blood flow reversal during transcarotid artery revascularization (TCAR), an “increasingly popular alternative to carotid endarterctomy and transfemoral artery carotid stenting,” which is designed to provide increased neuroprotection during the placement and angioplasty of the carotid stent. They analyzed the relationship between the length of TCAR flow reversal time (FRT) and major adverse events in 307 patients who underwent TCAR at four high-volume institutions. They separated patients into short (3-7minutes); medium(8-12 minutes); and long group (greater than 12 minutes) FRT. They designated a subset of the long group patients of those with greater than or equal to 20 or more minutes FRT, which they defined as the very long group. The stroke, myocardial infarction, and death rates at 30 days were assessed for all patients and were compared them between groups.

Dr. Kumins will detail how the overall stroke rate was 1.3%, with all strokes considered minor, and all patients showing full recovery. The four strokes occurred in patients with FRT of 6, 7, 11, and 12 minutes, showing no difference in the composite stroke/death or stroke/death/MI rates among the groups, the researchers indicated.

Dr. Kumins will discuss how flow reversal time does not affect stroke rates in patients undergoing TCAR, and suggest that operators should focus on the technical aspects of the procedure during flow reversal rather than being concerned about the amount of FRT.

Developments in carotid artery disease diagnosis and treatment have always been an important component of the VEITHsymposium programs and there will be sessions focusing on this critical area of patient management throughout the entire meeting.

This year, sessions will include a Tuesday focus on unresolved controversies in the management of carotid artery disease. The session will be moderated by Bruce A. Perler, MD, and L. Nelson Hopkins, MD, and include presentations on the value of using biomarkers of brain injury associated with carotid interventions, and how to assess and treat such adverse events as cerebral hyperfusion syndrome and intracranial artery dissection, as well as best medical treatments for carotid patients.

Of particular interest, there will be a debate Tuesday on the need for completion imaging with duplex or angiography with Hans-Henning Eckstein, MD, PhD, and R. Clement Darling III, MD.

Presentations will also address some of the latest treatment techniques for carotid artery disease. For example, on Wednesday morning, Norman H. Kumins, MD, of the Cleveland Medical Center, will present a study on the duration of blood flow reversal during transcarotid artery revascularization (TCAR), an “increasingly popular alternative to carotid endarterctomy and transfemoral artery carotid stenting,” which is designed to provide increased neuroprotection during the placement and angioplasty of the carotid stent. They analyzed the relationship between the length of TCAR flow reversal time (FRT) and major adverse events in 307 patients who underwent TCAR at four high-volume institutions. They separated patients into short (3-7minutes); medium(8-12 minutes); and long group (greater than 12 minutes) FRT. They designated a subset of the long group patients of those with greater than or equal to 20 or more minutes FRT, which they defined as the very long group. The stroke, myocardial infarction, and death rates at 30 days were assessed for all patients and were compared them between groups.

Dr. Kumins will detail how the overall stroke rate was 1.3%, with all strokes considered minor, and all patients showing full recovery. The four strokes occurred in patients with FRT of 6, 7, 11, and 12 minutes, showing no difference in the composite stroke/death or stroke/death/MI rates among the groups, the researchers indicated.

Dr. Kumins will discuss how flow reversal time does not affect stroke rates in patients undergoing TCAR, and suggest that operators should focus on the technical aspects of the procedure during flow reversal rather than being concerned about the amount of FRT.

Developments in carotid artery disease diagnosis and treatment have always been an important component of the VEITHsymposium programs and there will be sessions focusing on this critical area of patient management throughout the entire meeting.

This year, sessions will include a Tuesday focus on unresolved controversies in the management of carotid artery disease. The session will be moderated by Bruce A. Perler, MD, and L. Nelson Hopkins, MD, and include presentations on the value of using biomarkers of brain injury associated with carotid interventions, and how to assess and treat such adverse events as cerebral hyperfusion syndrome and intracranial artery dissection, as well as best medical treatments for carotid patients.

Of particular interest, there will be a debate Tuesday on the need for completion imaging with duplex or angiography with Hans-Henning Eckstein, MD, PhD, and R. Clement Darling III, MD.

Presentations will also address some of the latest treatment techniques for carotid artery disease. For example, on Wednesday morning, Norman H. Kumins, MD, of the Cleveland Medical Center, will present a study on the duration of blood flow reversal during transcarotid artery revascularization (TCAR), an “increasingly popular alternative to carotid endarterctomy and transfemoral artery carotid stenting,” which is designed to provide increased neuroprotection during the placement and angioplasty of the carotid stent. They analyzed the relationship between the length of TCAR flow reversal time (FRT) and major adverse events in 307 patients who underwent TCAR at four high-volume institutions. They separated patients into short (3-7minutes); medium(8-12 minutes); and long group (greater than 12 minutes) FRT. They designated a subset of the long group patients of those with greater than or equal to 20 or more minutes FRT, which they defined as the very long group. The stroke, myocardial infarction, and death rates at 30 days were assessed for all patients and were compared them between groups.

Dr. Kumins will detail how the overall stroke rate was 1.3%, with all strokes considered minor, and all patients showing full recovery. The four strokes occurred in patients with FRT of 6, 7, 11, and 12 minutes, showing no difference in the composite stroke/death or stroke/death/MI rates among the groups, the researchers indicated.

Dr. Kumins will discuss how flow reversal time does not affect stroke rates in patients undergoing TCAR, and suggest that operators should focus on the technical aspects of the procedure during flow reversal rather than being concerned about the amount of FRT.

This year at the VEITHsymposium, lower extremity arterial disease diagnosis and treatment takes pride of place in multiple sessions on each day.

For example, Tuesday will feature a special afternoon program on Hot New Topics In Lower Extremity Occlusive Disease Treatment, and on Wednesday morning, an associate faculty session will be held on Progress In Lower Extremity Occlusive Disease And Its Treatments.

In one particular presentation on Wednesday morning, Arsalan Wafi, MBBS, a clinical researcher at St. George’s Vascular Institute, London, will present a 10-year prospective study demonstrating that the poor mobility, lack of statin use, and socioeconomic deprivation are all associated with worse survival after a major lower limb amputation. Dr. Wafi will discuss how he and his colleagues assessed consecutive 805 major lower limb amputation patients seen in the Roehampton Rehabilitation Center between January 2007 and January 2018, using prospective records, which included demographics, etiologies of limb loss, operative details, medications, and mortality data over a 10-year follow-up period.

A total of 611 (76%) occurred in men, and 194 (24%) in women. Etiologies included diabetes mellitus, peripheral vascular disease, and other causes such as trauma, malignancy, sepsis, and complex regional pain syndrome.

Dr. Wafi will present data showing that living in a deprived area and being further away from the rehabilitation center were both significantly associated with poorer survival. Diabetes mellitus or peripheral vascular disease were associated with significantly shorter survival, compared with other etiologies, and not being on a statin was associated with significantly worse survival among the vascular patients. In addition, poorer overall mobility at discharge from rehabilitation was associated with poorer survival, according to the researchers. However there was no significant difference in survival between below-knee and above-knee amputees, or between unilateral and bilateral amputees.

Thursday will be highlighted by a session on New Devices For Treating Lower Extremity Lesions By Endovascular Or Open Techniques, and Friday will see a session New Developments In The Treatment Of Popliteal Diseases And Aneurysms.

This is only one of many such studies focused on lower extremity arterial disease at this year’s VEITHsymposium.

This year at the VEITHsymposium, lower extremity arterial disease diagnosis and treatment takes pride of place in multiple sessions on each day.

For example, Tuesday will feature a special afternoon program on Hot New Topics In Lower Extremity Occlusive Disease Treatment, and on Wednesday morning, an associate faculty session will be held on Progress In Lower Extremity Occlusive Disease And Its Treatments.

In one particular presentation on Wednesday morning, Arsalan Wafi, MBBS, a clinical researcher at St. George’s Vascular Institute, London, will present a 10-year prospective study demonstrating that the poor mobility, lack of statin use, and socioeconomic deprivation are all associated with worse survival after a major lower limb amputation. Dr. Wafi will discuss how he and his colleagues assessed consecutive 805 major lower limb amputation patients seen in the Roehampton Rehabilitation Center between January 2007 and January 2018, using prospective records, which included demographics, etiologies of limb loss, operative details, medications, and mortality data over a 10-year follow-up period.

A total of 611 (76%) occurred in men, and 194 (24%) in women. Etiologies included diabetes mellitus, peripheral vascular disease, and other causes such as trauma, malignancy, sepsis, and complex regional pain syndrome.

Dr. Wafi will present data showing that living in a deprived area and being further away from the rehabilitation center were both significantly associated with poorer survival. Diabetes mellitus or peripheral vascular disease were associated with significantly shorter survival, compared with other etiologies, and not being on a statin was associated with significantly worse survival among the vascular patients. In addition, poorer overall mobility at discharge from rehabilitation was associated with poorer survival, according to the researchers. However there was no significant difference in survival between below-knee and above-knee amputees, or between unilateral and bilateral amputees.

Thursday will be highlighted by a session on New Devices For Treating Lower Extremity Lesions By Endovascular Or Open Techniques, and Friday will see a session New Developments In The Treatment Of Popliteal Diseases And Aneurysms.

This is only one of many such studies focused on lower extremity arterial disease at this year’s VEITHsymposium.

This year at the VEITHsymposium, lower extremity arterial disease diagnosis and treatment takes pride of place in multiple sessions on each day.

For example, Tuesday will feature a special afternoon program on Hot New Topics In Lower Extremity Occlusive Disease Treatment, and on Wednesday morning, an associate faculty session will be held on Progress In Lower Extremity Occlusive Disease And Its Treatments.

In one particular presentation on Wednesday morning, Arsalan Wafi, MBBS, a clinical researcher at St. George’s Vascular Institute, London, will present a 10-year prospective study demonstrating that the poor mobility, lack of statin use, and socioeconomic deprivation are all associated with worse survival after a major lower limb amputation. Dr. Wafi will discuss how he and his colleagues assessed consecutive 805 major lower limb amputation patients seen in the Roehampton Rehabilitation Center between January 2007 and January 2018, using prospective records, which included demographics, etiologies of limb loss, operative details, medications, and mortality data over a 10-year follow-up period.

A total of 611 (76%) occurred in men, and 194 (24%) in women. Etiologies included diabetes mellitus, peripheral vascular disease, and other causes such as trauma, malignancy, sepsis, and complex regional pain syndrome.

Dr. Wafi will present data showing that living in a deprived area and being further away from the rehabilitation center were both significantly associated with poorer survival. Diabetes mellitus or peripheral vascular disease were associated with significantly shorter survival, compared with other etiologies, and not being on a statin was associated with significantly worse survival among the vascular patients. In addition, poorer overall mobility at discharge from rehabilitation was associated with poorer survival, according to the researchers. However there was no significant difference in survival between below-knee and above-knee amputees, or between unilateral and bilateral amputees.

Thursday will be highlighted by a session on New Devices For Treating Lower Extremity Lesions By Endovascular Or Open Techniques, and Friday will see a session New Developments In The Treatment Of Popliteal Diseases And Aneurysms.

This is only one of many such studies focused on lower extremity arterial disease at this year’s VEITHsymposium.

washington, dc – A real-world case series suggests intravascular lithotripsy (IVL) is safe and effective when used selectively to treat coronary arterial calcifications, according to data presented at the 2019 Transcatheter Cardiovascular Therapeutics (CRT) meeting.

Relative to other options, “IVL offers a more controlled means of calcium modification and it avoids the no-reflow phenomenon common to atherectomy in patients with a high calcium burden,” reported Julian Yeoh, MBBS, an interventional cardiologist affiliated with King’s College Hospital, London, UK.

On the basis of the DISRUPT CAD study, presented at the 2016 TCT meeting, IVL was approved in Europe for calcified coronary artery disease in May 2018. The Shockwave IVL device (Shockwave Medical) is currently approved in the U.S. only for treatment of calcified lesions associated with peripheral artery disease (PAD).

Ted Bosworth/MDedge News

SOURCE: Yeoh J et al. 2019 Cardiovascular Research Technologies (CRT) Meeting abstract.

washington, dc – A real-world case series suggests intravascular lithotripsy (IVL) is safe and effective when used selectively to treat coronary arterial calcifications, according to data presented at the 2019 Transcatheter Cardiovascular Therapeutics (CRT) meeting.

Relative to other options, “IVL offers a more controlled means of calcium modification and it avoids the no-reflow phenomenon common to atherectomy in patients with a high calcium burden,” reported Julian Yeoh, MBBS, an interventional cardiologist affiliated with King’s College Hospital, London, UK.

On the basis of the DISRUPT CAD study, presented at the 2016 TCT meeting, IVL was approved in Europe for calcified coronary artery disease in May 2018. The Shockwave IVL device (Shockwave Medical) is currently approved in the U.S. only for treatment of calcified lesions associated with peripheral artery disease (PAD).

Ted Bosworth/MDedge News

SOURCE: Yeoh J et al. 2019 Cardiovascular Research Technologies (CRT) Meeting abstract.

washington, dc – A real-world case series suggests intravascular lithotripsy (IVL) is safe and effective when used selectively to treat coronary arterial calcifications, according to data presented at the 2019 Transcatheter Cardiovascular Therapeutics (CRT) meeting.

Relative to other options, “IVL offers a more controlled means of calcium modification and it avoids the no-reflow phenomenon common to atherectomy in patients with a high calcium burden,” reported Julian Yeoh, MBBS, an interventional cardiologist affiliated with King’s College Hospital, London, UK.

On the basis of the DISRUPT CAD study, presented at the 2016 TCT meeting, IVL was approved in Europe for calcified coronary artery disease in May 2018. The Shockwave IVL device (Shockwave Medical) is currently approved in the U.S. only for treatment of calcified lesions associated with peripheral artery disease (PAD).

Ted Bosworth/MDedge News

SOURCE: Yeoh J et al. 2019 Cardiovascular Research Technologies (CRT) Meeting abstract.

WASHINGTON –Anticipating two pivotal trials scheduled for presentation at the 2019 annual meeting of the American College of Cardiology (ACC), an investigator-led study of transaortic valve replacement (TAVR) for aortic stenosis presented as a latebreaker at 2019 CRT meeting produced excellent results.

Ted Bosworth/MDedge News

Not least impressive, “our mortality rates are the lowest ever reported in any TAVR study at one year,” said Ronald Waksman, MD, Associate Director, Division of Cardiology, Medstar Heart Institute, Washington, DC.

In a population of patients with a median age of 71.1 years, all-cause mortality was just 3% at one year while the rate of deaths due to cardiovascular causes was only 1%, according to results of the 200-patient Low Risk TAVR study (LRT 1.0, NCT02628899) that Dr. Waksman presented.

In addition, there were low rates at one year for stroke (2.1%, none of which was deemed disability), myocardial infarction (1%), new onset atrial fibrillation (6.2%), and pacemaker placement (7.3%). The rate of rehospitalization for any cause was 20.4% but only 3.1% were considered related to TAVR. Rehospitalization for any cardiovascular cause at one year occurred in 6.8%.

Although leaflet thickening was observed at one year with imaging in 14%, this has not had any identifiable clinical consequences so far, and hemodynamics have remained stable, according to Dr. Waksman, who presented the interim 30-day outcomes at the 2018 CRT meeting.

These findings are raising expectations for two phase 3 TAVR trials in low-risk patients that are being presented as latebreakers at the 2019 ACC annual meeting. Both are large randomized trials comparing TAVR to surgical aortic valve replacement (SAVR) in low risk patients. Each trial is testing a single type of value and is funded by the valve manufacturers.

In the PARTNER-3 trial, patients randomized to TAVR received the Sapien 3 valve (Edwards Lifesciences). In the other latebreaking trial, patients randomized to TAVR received an Evolut valve (Medtronic Cardiovascular). Both are comparing TAVR to SAVR with a composite primary outcome that includes mortality and stroke measured at 30 days and one year.

In contrast to these trials, LRT 1.0 was conducted with no funding from a third party, according to Dr. Waksman. The eleven centers participated in the study at their own cost. Also, the choice of TAVR device was left to the discretion of the interventional cardiologist. Finally, most of the participating centers, although experienced in TAVR, did not have a high-volume case load. In general, with the exception of Dr. Waksman’s center, most performed 100 to 150 TAVRs per year.

“We were struck by the excellence of the performance of these sites,” said Dr. Waksman, noting that a comparison of outcomes at his center relative to the lower volume centers showed no significant differences in outcome.

This real-world experience raises the bar for the pivotal phase 3 trials, which, if positive, are expected to lead the FDA to grant an indication for TAVR in low-risk patients, according to Dr. Waksman. He announced that an LRT 2.0 trial, which will again include centers performing TAVRs at moderate volumes, is now enrolling.

SOURCE: 2019 Cardiovascular Research Technologies (CRT) Meeting.

WASHINGTON –Anticipating two pivotal trials scheduled for presentation at the 2019 annual meeting of the American College of Cardiology (ACC), an investigator-led study of transaortic valve replacement (TAVR) for aortic stenosis presented as a latebreaker at 2019 CRT meeting produced excellent results.

Ted Bosworth/MDedge News

Not least impressive, “our mortality rates are the lowest ever reported in any TAVR study at one year,” said Ronald Waksman, MD, Associate Director, Division of Cardiology, Medstar Heart Institute, Washington, DC.

In a population of patients with a median age of 71.1 years, all-cause mortality was just 3% at one year while the rate of deaths due to cardiovascular causes was only 1%, according to results of the 200-patient Low Risk TAVR study (LRT 1.0, NCT02628899) that Dr. Waksman presented.

In addition, there were low rates at one year for stroke (2.1%, none of which was deemed disability), myocardial infarction (1%), new onset atrial fibrillation (6.2%), and pacemaker placement (7.3%). The rate of rehospitalization for any cause was 20.4% but only 3.1% were considered related to TAVR. Rehospitalization for any cardiovascular cause at one year occurred in 6.8%.

Although leaflet thickening was observed at one year with imaging in 14%, this has not had any identifiable clinical consequences so far, and hemodynamics have remained stable, according to Dr. Waksman, who presented the interim 30-day outcomes at the 2018 CRT meeting.

These findings are raising expectations for two phase 3 TAVR trials in low-risk patients that are being presented as latebreakers at the 2019 ACC annual meeting. Both are large randomized trials comparing TAVR to surgical aortic valve replacement (SAVR) in low risk patients. Each trial is testing a single type of value and is funded by the valve manufacturers.

In the PARTNER-3 trial, patients randomized to TAVR received the Sapien 3 valve (Edwards Lifesciences). In the other latebreaking trial, patients randomized to TAVR received an Evolut valve (Medtronic Cardiovascular). Both are comparing TAVR to SAVR with a composite primary outcome that includes mortality and stroke measured at 30 days and one year.

In contrast to these trials, LRT 1.0 was conducted with no funding from a third party, according to Dr. Waksman. The eleven centers participated in the study at their own cost. Also, the choice of TAVR device was left to the discretion of the interventional cardiologist. Finally, most of the participating centers, although experienced in TAVR, did not have a high-volume case load. In general, with the exception of Dr. Waksman’s center, most performed 100 to 150 TAVRs per year.

“We were struck by the excellence of the performance of these sites,” said Dr. Waksman, noting that a comparison of outcomes at his center relative to the lower volume centers showed no significant differences in outcome.

This real-world experience raises the bar for the pivotal phase 3 trials, which, if positive, are expected to lead the FDA to grant an indication for TAVR in low-risk patients, according to Dr. Waksman. He announced that an LRT 2.0 trial, which will again include centers performing TAVRs at moderate volumes, is now enrolling.

SOURCE: 2019 Cardiovascular Research Technologies (CRT) Meeting.

WASHINGTON –Anticipating two pivotal trials scheduled for presentation at the 2019 annual meeting of the American College of Cardiology (ACC), an investigator-led study of transaortic valve replacement (TAVR) for aortic stenosis presented as a latebreaker at 2019 CRT meeting produced excellent results.

Ted Bosworth/MDedge News

Not least impressive, “our mortality rates are the lowest ever reported in any TAVR study at one year,” said Ronald Waksman, MD, Associate Director, Division of Cardiology, Medstar Heart Institute, Washington, DC.

In a population of patients with a median age of 71.1 years, all-cause mortality was just 3% at one year while the rate of deaths due to cardiovascular causes was only 1%, according to results of the 200-patient Low Risk TAVR study (LRT 1.0, NCT02628899) that Dr. Waksman presented.

In addition, there were low rates at one year for stroke (2.1%, none of which was deemed disability), myocardial infarction (1%), new onset atrial fibrillation (6.2%), and pacemaker placement (7.3%). The rate of rehospitalization for any cause was 20.4% but only 3.1% were considered related to TAVR. Rehospitalization for any cardiovascular cause at one year occurred in 6.8%.

Although leaflet thickening was observed at one year with imaging in 14%, this has not had any identifiable clinical consequences so far, and hemodynamics have remained stable, according to Dr. Waksman, who presented the interim 30-day outcomes at the 2018 CRT meeting.

These findings are raising expectations for two phase 3 TAVR trials in low-risk patients that are being presented as latebreakers at the 2019 ACC annual meeting. Both are large randomized trials comparing TAVR to surgical aortic valve replacement (SAVR) in low risk patients. Each trial is testing a single type of value and is funded by the valve manufacturers.

In the PARTNER-3 trial, patients randomized to TAVR received the Sapien 3 valve (Edwards Lifesciences). In the other latebreaking trial, patients randomized to TAVR received an Evolut valve (Medtronic Cardiovascular). Both are comparing TAVR to SAVR with a composite primary outcome that includes mortality and stroke measured at 30 days and one year.

In contrast to these trials, LRT 1.0 was conducted with no funding from a third party, according to Dr. Waksman. The eleven centers participated in the study at their own cost. Also, the choice of TAVR device was left to the discretion of the interventional cardiologist. Finally, most of the participating centers, although experienced in TAVR, did not have a high-volume case load. In general, with the exception of Dr. Waksman’s center, most performed 100 to 150 TAVRs per year.

“We were struck by the excellence of the performance of these sites,” said Dr. Waksman, noting that a comparison of outcomes at his center relative to the lower volume centers showed no significant differences in outcome.

This real-world experience raises the bar for the pivotal phase 3 trials, which, if positive, are expected to lead the FDA to grant an indication for TAVR in low-risk patients, according to Dr. Waksman. He announced that an LRT 2.0 trial, which will again include centers performing TAVRs at moderate volumes, is now enrolling.

SOURCE: 2019 Cardiovascular Research Technologies (CRT) Meeting.