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PARIS – A next-generation system for transcatheter aortic valve replacement produced substantially less aortic regurgitation, compared with the historical performance of marketed, percutaneous valve-replacement systems in a pilot, multicenter, uncontrolled study with 60 patients.
At 30 days after transcatheter aortic valve replacement (TAVR) using the investigational Lotus valve system, 1 of 53 patients assessed had moderate aortic regurgitation and no patients had severe regurgitation, Dr. Ian T. Meredith said at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions. In addition, 10 patients (19%) had mild regurgitation, 5 patients (9%) had trace regurgitation, and 37 patients, 70%, had no regurgitation.
By contrast, results from one of the most recent TAVR studies reported using the Sapien valve systems now on the worldwide market in more than 400 patients (the Placement of Aortic Transcatheter Valves [PARTNER] II cohort B trial) showed a roughly 20% incidence of severe or moderate aortic regurgitation 30 days after TAVR, with about 40% of patients having mild regurgitation and fewer than 20% of patients with no regurgitation.
Dr. Meredith attributed the superior regurgitation performance with the new device to a key feature of the Lotus valve, an adaptive seal around the valve that he likened to "cling wrap" that fills most or all of the small spaces around the valve after it’s placed. This produces a tight seal and prevents regurgitation, said Dr. Meredith, professor and director of MonasHeart at Monash University in Victoria, Australia.
The other major feature of the new valve is that it is easily retrievable after deployment, allowing operators to reposition it if needed following initial deployment. In the 60 cases reported by Dr. Meredith operators took advantage of the retrievable feature in 16 cases: 12 times to reposition the valve, and in 4 cases, they completely removed the first valve and replaced it with a different-size (the valves used in the study came in two different sizes).
The REPRISE (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System–Evaluation of Safety and Performance) II trial enrolled 60 patients with severe, calcific aortic stenosis at seven centers in Australia and France during October 2012-January 2013. The patients averaged 86 years of age, and their average Society of Thoracic Surgeons risk score was 6.4%. At baseline their average aortic valve gradient was 47.5 mm Hg.
Valves were placed successfully in all 60 patients. The study’s primary performance endpoint was to produce an average aortic valve gradient of 18 mm Hg or less measured 30 days after valve placement. Actual performance was an average aortic valve gradient of 11.3 mm Hg in 52 patients measured at 30 days. In addition, one patient died, two patients had a disabling stroke, three had a nondisabling stroke, and five had a life-threatening bleed. The overall 30-day safety composite-event rate was 19%.
Valve calcification is the main cause of regurgitation following TAVR, Dr. Meredith said in an interview. The calcium in the aortic annulus appears in various shapes and sizes and can be difficult to flatten so that a simple valve seal could still be subject to leaks. The adaptive seal of the Lotus valve is better able to stop leaks, he said.
The study was sponsored by Boston Scientific, which is developing the Lotus valve system. Dr. Meredith said that he has been a consultant to and has received honoraria from Boston Scientific and Medtronic.
On Twitter @mitchelzoler
PARIS – A next-generation system for transcatheter aortic valve replacement produced substantially less aortic regurgitation, compared with the historical performance of marketed, percutaneous valve-replacement systems in a pilot, multicenter, uncontrolled study with 60 patients.
At 30 days after transcatheter aortic valve replacement (TAVR) using the investigational Lotus valve system, 1 of 53 patients assessed had moderate aortic regurgitation and no patients had severe regurgitation, Dr. Ian T. Meredith said at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions. In addition, 10 patients (19%) had mild regurgitation, 5 patients (9%) had trace regurgitation, and 37 patients, 70%, had no regurgitation.
By contrast, results from one of the most recent TAVR studies reported using the Sapien valve systems now on the worldwide market in more than 400 patients (the Placement of Aortic Transcatheter Valves [PARTNER] II cohort B trial) showed a roughly 20% incidence of severe or moderate aortic regurgitation 30 days after TAVR, with about 40% of patients having mild regurgitation and fewer than 20% of patients with no regurgitation.
Dr. Meredith attributed the superior regurgitation performance with the new device to a key feature of the Lotus valve, an adaptive seal around the valve that he likened to "cling wrap" that fills most or all of the small spaces around the valve after it’s placed. This produces a tight seal and prevents regurgitation, said Dr. Meredith, professor and director of MonasHeart at Monash University in Victoria, Australia.
The other major feature of the new valve is that it is easily retrievable after deployment, allowing operators to reposition it if needed following initial deployment. In the 60 cases reported by Dr. Meredith operators took advantage of the retrievable feature in 16 cases: 12 times to reposition the valve, and in 4 cases, they completely removed the first valve and replaced it with a different-size (the valves used in the study came in two different sizes).
The REPRISE (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System–Evaluation of Safety and Performance) II trial enrolled 60 patients with severe, calcific aortic stenosis at seven centers in Australia and France during October 2012-January 2013. The patients averaged 86 years of age, and their average Society of Thoracic Surgeons risk score was 6.4%. At baseline their average aortic valve gradient was 47.5 mm Hg.
Valves were placed successfully in all 60 patients. The study’s primary performance endpoint was to produce an average aortic valve gradient of 18 mm Hg or less measured 30 days after valve placement. Actual performance was an average aortic valve gradient of 11.3 mm Hg in 52 patients measured at 30 days. In addition, one patient died, two patients had a disabling stroke, three had a nondisabling stroke, and five had a life-threatening bleed. The overall 30-day safety composite-event rate was 19%.
Valve calcification is the main cause of regurgitation following TAVR, Dr. Meredith said in an interview. The calcium in the aortic annulus appears in various shapes and sizes and can be difficult to flatten so that a simple valve seal could still be subject to leaks. The adaptive seal of the Lotus valve is better able to stop leaks, he said.
The study was sponsored by Boston Scientific, which is developing the Lotus valve system. Dr. Meredith said that he has been a consultant to and has received honoraria from Boston Scientific and Medtronic.
On Twitter @mitchelzoler
PARIS – A next-generation system for transcatheter aortic valve replacement produced substantially less aortic regurgitation, compared with the historical performance of marketed, percutaneous valve-replacement systems in a pilot, multicenter, uncontrolled study with 60 patients.
At 30 days after transcatheter aortic valve replacement (TAVR) using the investigational Lotus valve system, 1 of 53 patients assessed had moderate aortic regurgitation and no patients had severe regurgitation, Dr. Ian T. Meredith said at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions. In addition, 10 patients (19%) had mild regurgitation, 5 patients (9%) had trace regurgitation, and 37 patients, 70%, had no regurgitation.
By contrast, results from one of the most recent TAVR studies reported using the Sapien valve systems now on the worldwide market in more than 400 patients (the Placement of Aortic Transcatheter Valves [PARTNER] II cohort B trial) showed a roughly 20% incidence of severe or moderate aortic regurgitation 30 days after TAVR, with about 40% of patients having mild regurgitation and fewer than 20% of patients with no regurgitation.
Dr. Meredith attributed the superior regurgitation performance with the new device to a key feature of the Lotus valve, an adaptive seal around the valve that he likened to "cling wrap" that fills most or all of the small spaces around the valve after it’s placed. This produces a tight seal and prevents regurgitation, said Dr. Meredith, professor and director of MonasHeart at Monash University in Victoria, Australia.
The other major feature of the new valve is that it is easily retrievable after deployment, allowing operators to reposition it if needed following initial deployment. In the 60 cases reported by Dr. Meredith operators took advantage of the retrievable feature in 16 cases: 12 times to reposition the valve, and in 4 cases, they completely removed the first valve and replaced it with a different-size (the valves used in the study came in two different sizes).
The REPRISE (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System–Evaluation of Safety and Performance) II trial enrolled 60 patients with severe, calcific aortic stenosis at seven centers in Australia and France during October 2012-January 2013. The patients averaged 86 years of age, and their average Society of Thoracic Surgeons risk score was 6.4%. At baseline their average aortic valve gradient was 47.5 mm Hg.
Valves were placed successfully in all 60 patients. The study’s primary performance endpoint was to produce an average aortic valve gradient of 18 mm Hg or less measured 30 days after valve placement. Actual performance was an average aortic valve gradient of 11.3 mm Hg in 52 patients measured at 30 days. In addition, one patient died, two patients had a disabling stroke, three had a nondisabling stroke, and five had a life-threatening bleed. The overall 30-day safety composite-event rate was 19%.
Valve calcification is the main cause of regurgitation following TAVR, Dr. Meredith said in an interview. The calcium in the aortic annulus appears in various shapes and sizes and can be difficult to flatten so that a simple valve seal could still be subject to leaks. The adaptive seal of the Lotus valve is better able to stop leaks, he said.
The study was sponsored by Boston Scientific, which is developing the Lotus valve system. Dr. Meredith said that he has been a consultant to and has received honoraria from Boston Scientific and Medtronic.
On Twitter @mitchelzoler
AT EUROPCR 2013
Major finding: The Lotus valve had a 79% rate of no or trace aortic-valve regurgitation 30 days after transcatheter aortic valve replacement.
Data source: An uncontrolled, multicenter study with 60 patients.
Disclosures: The study was sponsored by Boston Scientific, which is developing the Lotus valve system. Dr. Meredith said that he has been a consultant to and has received honoraria from Boston Scientific and Medtronic.
