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

Zoll LifeVest wearable defibrillator, WEARIT-II Registry results, CardioStim EuroPace 2016
News | Defibrillator Monitors| June 21, 2016
Zoll Medical Corp. announced that patients experience a high one-year survival rate following use of the LifeVest...
Sponsored Content | Videos | Structural Heart Occluders| June 16, 2016
This is an animation of how a Gore Cardioform Septal Occluder is implanted for the transcatheter closure of ASDs or P
GE Healthcare, Getinge Group, Maquet, Discovery IGS 730 angiography system, Magnus operating table, integrated, hybrid OR

GE Healthcare's Discovery IGS 730 angiography system

Technology | Hybrid OR| June 13, 2016
GE Healthcare and Getinge Group announced the U.S. launch of a new, highly flexible angiography solution for surgery,...
Inventory management, cath lab inventory management, automated inventory management
Sponsored Content | Webinar | Inventory Management| June 10, 2016
Do you find products are stocked based on intuition rather than actual utilization based on clinical demand?
TeleHealthRobotics, Tele-Robotic Ultrasound, TRUDI, robotic ultrasound

The Tele-Robotic Ultrasound for Distance Imaging (TRUDI) system uses a robotic arm so a remote sonographer can control the echo probe without the need for them to be in the same room or even be in the hospital during an exam or procedure. 

News | Cardiovascular Ultrasound| June 09, 2016
June 9, 2016 — The American Society of Echocardiography (ASE) will host Echovation Challenge 2016, a competition for
heart failure, muscle bleeding, British Cardiovascular Conference, MRI
News | Heart Failure| June 08, 2016
The amount a heart ‘bleeds’ following a heart attack can predict the severity of future heart failure, according to...
Biotronik, ORIENT trial results, EuroPCR 2016, Orsiro DES, hybrid drug-eluting stent
News | Stents Drug Eluting| June 03, 2016
Biotronik announced results establishing non-inferiority of the Orsiro hybrid drug-eluting stent (DES) to the Resolute...
News | Drug-Eluting Balloons| June 03, 2016
June 3, 2016 — Cardionovum GmbH recently announced the completion of enrollment of the RAPID trial.
radial access, transradial
Feature | Radial Access| May 27, 2016 | Dave Fornell
The use of transradial artery vascular access for percutaneous coronary intervention (PCI) in the United States has s
Overlay Init