Patients treated with Edwards Lifesciences’ (NYSE:EW) Sapien heart valve had a lower mortality rate and spent less time in hospitals at the two-year mark, according to the data released at this year’s Transcatheter Cardiovascular Therapeutics symposium.
The Partner trial consisted of patients with aortic stenosis, randomized to receive a Sapien valve with transcatheter aortic valve replacement surgery or traditional open-heart surgery.
In the first group of the Partner trial, 244 patients received transfemoral TAVR, 104 received transapical TAVR and the remaining patients received the standard surgical valve replacement surgery.
"Remarkably, the median days alive outside of the hospital was 699 days in TAVR patients and 355 days for standard therapy patients – a difference of nearly one year," said Raj Makkar, associate director of the Cedars-Sinai Heart Institute in prepared remarks. "This demonstrates that without the Sapien valve, patients that survived spent significantly more time in the hospital."
Sapien patients also had an increased quality of life compared to open-heart surgery patients, according to the company. Transfemoral patients felt better at one month than open-heart surgery patients, and felt comparable at one year.
Transfemoral valve replacement procedure was 87 minutes faster than traditional surgery and the average hospital stay was six days shorter.
The transapical trial of the Sapien valve was spiked after several patients experienced stroke, kidney failure and death.
The Sapien device won FDA pre-market approval just last week, becoming the first device enabling coronary valve replacement without open-heart surgery to hit the U.S. market. Approval was granted for an implantation procedure through the femoral artery in the leg, and only for patients at too high a risk for open-heart surgery.
Here’s a look at some other results coming out of the TCT 2011 conference:
St. Jude’s Portico valve study sees promising results
St. Jude Medical’s (NYSE:STJ) Portico transcatheter aortic heart valve saw promising results after a 10-patient feasibility study in Ireland. Read more
Tryton announces live case transmission
At the TCT conference, Tryton Medical Inc. transmitted a live satellite feed of a clinical Tryton stent case to an audience of several hundred interventional cardiologists. Read more
Researchers call Edwards’ study outcomes “reassuring”
The results of Edwards’ two year Partner clinical trial were reassuring for the TAVI industry, according to analysts from Leerink Swann. Read More
Elixir announces pivotal clinical trial for DESolve Nx system
Elixir Medical Corp. announced an international 120-patient pivotal trial for its DESolve Nx bioresorbable coronary scaffold system. Read more
And check out these briefs from TCT Daily:
- RIFLE STEACS: Radial approach safer than femoral in STEMI
- TAVR remains superior to standard therapy at 2 years
- Thrombectomy use not associated with smaller infarcts at one year
- Transfemoral TAVR improved QOL, costs vs. surgery
- TCT project II outcoming webcast
- Transapical TAVR inferior to surgery for operable elderly patients
- Embolic protection devices for TAVR show promise