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

European interventional cardiology market, drug-eluting stents, Abbott Laboratories, Boston Scientific, Medtronic

Boston Scientific's Eluvia drug-eluting vascular stent system. Image courtesy of Boston Scientific.

Feature | Stents| July 31, 2015
According to a new report on the Europe market for interventional cardiology by iData Research, drug-eluting stents...
Hansen Medical, Magellan 10 French Robotic Catheter, FDA 510(k) clearance
Technology | Robotic Systems| July 29, 2015
The Magellan 10 French Robotic Catheter from Hansen Medical is indicated for use in the peripheral vasculature.
Feature | Heart Valve Repair| July 28, 2015
Boston Scientific announced CE Mark and U.S. Food and Drug Administration (FDA) clearance for the Safari2 Pre-Shaped...
Products | Guidewires| July 28, 2015
The Safari2 Pre-Shaped Guidewire.
CSI, ViperWire Advance Peripheral Guide Wire with Flex Tip, Stealth, Diamondback

Diamondback 360 Peripheral OAS image courtesy of Cardiovascular Systems Inc.

Technology | Atherectomy Devices| July 22, 2015
Cardiovascular Systems Inc. announced that it has received U.S. Food and Drug Administration (FDA) clearance for its...
Direct Flow Medical, Transcatheter Aortic Valve System, SALUS Trial, FDA
News | Heart Valve Repair| July 22, 2015
Direct Flow Medical Inc. received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug...
The Medicines Company, bivalirudin, Angiomax, litigation, Hospira Inc.
News | Cath Lab| July 22, 2015
The Medicines Company announced the U.S. Court of Appeals for the Federal Circuit Court has ruled against the company...
GlobalData, TAVR, Edwards, Medtronic, CoreValve Evolut R, Sapien 3

Sapien 3 image courtesy of Edwards Lifesciences

News | Heart Valve Repair| July 21, 2015
The recent U.S. Food and Drug Administration (FDA) approvals of two next-generation transcatheter aortic valve...
Boston Scientific, fully absorbable scaffold, FAST study, resorbable
Feature | Stents Bioresorbable| July 20, 2015
Boston Scientific has initiated a study of the company's first fully resorbable drug-eluting scaffold system. The Fully...
Veryan Medical, BioMimics 3D femoropopliteal stent, MIMICS-2 study, PAD
News | Stents Peripheral| July 17, 2015
Veryan Medical announced that the first subject has been enrolled in their MIMICS-2 study at Universitäts-Herzzentrum...
Overlay Init