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

the Impella pVAD improves survival, mortality in AMI heart attack with cardiogenic shock
Feature | Hemodynamic Support Devices| April 28, 2017 | Dave Fornell
Recent clinical study data presented at the American College of Cardiology (ACC) 2017 meeting show new treatment prot
New Twelve-Month Data Show Efficacy of Pulsar-18 Bare Metal Stent
News | Stents Peripheral| April 28, 2017
Biotronik’s Pulsar-18 bare metal stent (BMS) has yielded high primary patency in a real-world setting, according to the...
New Hampshire Hospital Expands Vascular Care with Toshiba Medical's Infinix-I Sky +
News | Angiography| April 27, 2017
Wentworth-Douglass Hospital in Dover, N.H., installed Toshiba Medical’s Infinix-i Sky + angiography system in its...
Mercator MedSystems Announces First Enrollment in TANGO Trial for Below-the-Knee Vascular Disease
News | Peripheral Arterial Disease (PAD)| April 27, 2017
Mercator MedSystems Inc. announced the first patient enrollment into the TANGO (Temsirolimus Adventitial Delivery to...
News | Venous Therapies| April 26, 2017
A new Varicose Vein Registry has begun producing useful outcomes information, as reported in the May edition of the...
Twelve-Month Data Positive for Ranger Paclitaxel-Coated Balloon Catheter
News | Drug-Eluting Balloons| April 26, 2017
Boston Scientific announced results from the RANGER SFA trial for the Ranger Paclitaxel-Coated PTA Balloon Catheter at...
Alabama Medical Center First in Southeast to Offer CoreValve Evolut Pro TAVR Device
News | Heart Valve Technology| April 20, 2017
The Structural Heart Program at Princeton Baptist Medical Center, (Birmingham, Ala.) recently became the first center...
Updated AATS Guidelines Help Cardiovascular Surgeons Navigate Challenges of Managing Ischemic Mitral Regurgitation
News | Heart Valve Technology| April 20, 2017
April 20, 2017 — Mitral regurgitation can occur in up to 50 percent of patients with ischemic heart disease and even
CSI recall for saline pump on its atherectomy system
News | Atherectomy Devices| April 19, 2017
Cardiovascular Systems Inc. (CSI) announced April 18 it had initiated a voluntary recall of its 7-10014 Saline Infusion...
Overlay Init