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

radiation dose in the cath lab
News | Radiation Dose Management| May 02, 2016
May 2, 2016 — Starting at the Society for Cardiovascular Angiography and Interventions (SCAI) 2016 annual meeting May
Feature | Business| April 28, 2016 | Dave Fornell
 
Technology | Stents Peripheral| April 27, 2016
Veniti Inc. announced the first successful treatment with the Vici Verto Venous Stent System of a patient suffering...
Mitralign Percutaneous Annuloplasty System, MPAS, CE Mark approval
News | Annuloplasty Rings| April 27, 2016
Mitralign Inc. announced its Mitralign Percutaneous Annuloplasty System (MPAS) has received CE mark approval from its...
Auris Surgical Robotics, acquisition, Hansen Medical
News | Robotic Systems| April 26, 2016
Auris Surgical Robotics Inc. and Hansen Medical Inc. announced that they have signed a definitive merger agreement...
Siemens Sensis Vibe, hemodyanamics system

Siemens released the Sensis Vibe hemodyanamics system at ACC.16. The newer system offers better integration of cath lab data into cath lab reports and the electronic medical record (EMR).

Feature | ACC| April 25, 2016 | Jon Brubaker, MBA, RCVT, Tom Watson, BS, RCVT, and Sabrina Newell MS, RCS
There were several trends seen in new cardiovascular technologies showcased on the expo floor at the 2016 American...
Medtronic, Drug-Filled Stent, RevElution Trial results, ACC.16, CE Mark
News | Stents Drug Eluting| April 21, 2016
Medtronic plc announced new clinical data from one of the endpoints in the RevElution Trial for its novel, next-...
Boston Scientific, Fetch 2 aspiration catheter, Class 1 recall
News | Thrombectomy Devices| April 20, 2016
April 20, 2016 — Boston Scientific Corp. announced a U.S.
TAVR, Sapien 3, ACC.16
Feature | Heart Valve Repair| April 19, 2016 | Michael J. Rinaldi, M.D., FACC, FSCAI
The continuation of positive clinical trial data for transcatheter aortic valve repair (TAVR), showing it is equal to
ischemic postconditioning, STEMI patients, clinical outcomes, ACC.16
News | Cath Lab| April 19, 2016
A large randomized controlled trial of ischemic postconditioning in patients who had experienced ST-segment elevation...
Overlay Init