Feature | November 04, 2013

Second Generation Transcatheter Aortic Valve Shown to Successfully Address TAVR Complications

Results of the REPRISE II trial reported at TCT 2013

heart valve repair hybrid or cath lab reprise II boston scientific lotus tct
November 4, 2013 — In a clinical trial of the Boston Scientific Lotus valve, a second-generation transcatheter aortic valve, the device demonstrated low rates of complications that are sometimes seen in transcatheter aortic valve replacement (TAVR), including challenges with positioning, post-procedure paravalvular aortic regurgitation, vascular complications and stroke. 
 
The findings were presented at the 25th annual Transcatheter Cardiovascular Therapeutics scientific symposium (TCT 2013).
 
The valve studied in REPRISE II is fully retrievable and repositionable with an adaptive seal intended to minimize paravalvular regurgitation, a complication that has been associated with higher mortality among patients undergoing TAVR. In this prospective, single-arm, multicenter study, symptomatic patients at high risk for surgery received the Lotus valve to treat calcific aortic stenosis. 
 
The trial enrolled 120 patients; mean age was 84.4±5.3 years, 56.7 percent were female and 75.8 percent were considered New York Heart Association (NYHA) Class III or IV. The mean Society of Thoracic Surgeons score was 7.1±4.6 percent and all patients were confirmed by their site heart team to be at high risk for surgery due to frailty or associated comorbidities. 
 
The valve was successfully implanted in all 120 patients with valve repositioning and retrieval performed as needed. There was no embolization, ectopic valve deployment or need for implantation of a second prosthetic valve. 
 
The primary device performance endpoint was the mean aortic valve pressure gradient at 30 days compared to a performance goal of 18 mmHg; the primary safety endpoint was 30-day mortality. The primary device performance endpoint was met with a 30 day mean aortic valve pressure gradient of 11.5±5.2 mmHg; mean effective orifice area was 1.7±0.4 cm2.
 
All cause mortality and disabling stroke were low at 30 days (4.2 percent and 1.7 percent, respectively). Additional clinical event rates were consistent with those reported for other valves. Aortic regurgitation at 30 days was negligible in 99 percent of patients (78.3 percent none, 5.2 percent trace and 15.5 percent mild). The total stroke rate, disabling and non-disabling, was 5.9 percent, which is the same as the rate as the Edward's Sapien valve's performance in the PARTNER trial.
 
“These findings suggest this valve, which is a differentiated, second generation TAVR device, will be a valuable addition for the treatment of severe aortic stenosis,” said Ian Meredith, MBBS, Ph.D., director, Monash HEART, executive director, Monash Cardiovascular Research Centre, professor of medicine, Monash University in Melbourne, Australia, and lead investigator of the study.
 
For more information: www.crf.org, www.bostonscientific.com

Related Content

Sponsored Content | Videos | Angiography| December 07, 2016
Shimadzu's latest generation interventional lab angiography imaging system, the Trinias, enables advanced imaging cap
Lotus Edge valve
News | Heart Valve Technology| December 07, 2016
December 7, 2016 — Boston Scientific announced a definitive agreement to acquire certain manufacturing assets and cap
Impella CP, Abiomed
News | Hemodynamic Support Devices| December 07, 2016
December 7, 2016 — Abiomed Inc. announced it has expanded its U.S.
Vascular Solutions, Teleflex
Feature | December 07, 2016
December 7, 2016 — Teleflex Inc. and Vascular Solutions Inc.
Siemens Healthineers, PURE Platform, angiography, EVAR, CTO, RSNA 2016
News | Angiography| December 07, 2016
December 7, 2016 — At the 102nd Scientific Assembly and Annual Meeting of the Radiological Society of North America (
Spectranetics, Stellarex 0.014-inch DCB, CE Mark
News | Drug-Eluting Balloons| December 06, 2016
December 6, 2016 — The Spectranetics Corp.
TCT 2016, TCT.16, main arena, late breaking trials, transcatheter cardiovascular therapeutics

There were several hot topics that came out of the 2016 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting Oct. 29 - Nov. 2, which made this month's top 20 list, including several videos. Number 4 on the list of content was the result of the EXCEL Trial key TCT late-breaker, which showed stenting is equal in outcomes to surgery for the first time, when using one of the latest generation drug-eluting stents. 

Feature | December 05, 2016
December 5, 2016 — Here is the list of the top 20 most popular pieces of content on the Diagnostic and Interventional
Cardioband, valtech, Edwards Lifesciences, transcatheter mitral repair, transcatheter tricuspid valve repair, transcatheter annuloplasty

An illustration of how the transcatheter Cardioband System can used as a non-surgical form on annuloplasty repair. 

News | Heart Valve Technology| December 02, 2016
December 2, 2016 — Edwards Lifesciences Corp.
Sponsored Content | Videos | Robotic Systems| November 22, 2016
Corindus Vascular Robotics received U.S.
Infinix-i Sky +, RSNA 2016, Toshiba, angiography systems

Toshiba Medical’s Infinix-i product line, including the Infinix-i Sky +, delivers patient access, image quality and safety features for virtually any image-guided procedure, including those in hybrid OR settings.

News | Angiography| November 21, 2016
November 21, 2016 – Healthcare providers seeking versatile imaging technology for their angiography needs can find a
Overlay Init