Navigation Links
Study examines effectiveness, safety of transcatheter aortic valve replacement in US
Date:11/17/2013

Chicago Michael J. Mack, M.D., of the Baylor Health Care System, Plano, Texas, and colleagues describe the experience in the U.S. with transcatheter aortic valve replacement (TAVR), including patient selection, procedural details, and in-hospital and 30-day outcomes following TAVR, a less invasive procedure than open heart-valve surgery for replacing the aortic valve in the heart.

In November 2011, the U.S. Food and Drug Administration (FDA) approved use of a valve that could be implanted using a catheter for TAVR for the treatment of severe, symptomatic aortic stenosis in patients with inoperable status. The label for the valve was expanded in September 2012 to include patients at high-risk but operable status. Since commercial approval, this first-to-U.S.-market TAVR device has been introduced to nearly 250 U.S. clinical sites. "Although the [initial] trials demonstrated efficacy of TAVR within a select cohort of patients and hospital centers, there are no data on dissemination and utilization patterns of this technology in routine clinical practice in the United States. Additionally, concerns persist regarding the safety and effectiveness of this novel technology as it moves beyond protocolized trial care and highly experienced centers and operators," according to background information in the study.

For this study, the researchers gathered results from all eligible U.S. TAVR cases (n = 7,710) from 224 participating registry hospitals following the device commercialization (November 2011 - May 2013). Successful device implantation occurred in 7,069 patients (92 percent). In-hospital mortality was 5.5 percent. Other major complications included stroke (2.0 percent), dialysis-dependent renal failure (1.9 percent), and major vascular injury (6.4 percent).

Median hospital stay was 6 days, with 4,613 patients (63 percent) discharged home. Among patients with available follow-up at 30 days (n = 3,133), mortality was 7.6 percent (noncardiovascular cause, 52 percent); stroke occurred in 2.8 percent, and new dialysis in 2.5 percent.

"This analysis represents the first public report from the U.S. national Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry and documents 2 major findings. First, postapproval commercial introduction of this new technology with an early-generation device has yielded success rates and complication patterns that are similar to those documented in carefully performed randomized trials. Second, the outcomes of procedures even with this early-generation approved device are similar to the global experience of TAVR, which now is based on second- and third-generation improved devices. These findings help address a lingering question of clinical outcomes with the first-generation TAVR device after controlled U.S. dissemination to a relatively narrow group of treatment centers," the authors write. "Longer-term follow-up is essential to assess continued safety and efficacy as well as patient health status."


'/>"/>

Contact: Susan Hall
Susan.Hall@baylorhealth.edu
214-566-2589
The JAMA Network Journals
Source:Eurekalert

Related medicine news :

1. Study Suggests Vaccine May Help Kids With Brain Cancer
2. Study reveals how cancer drug causes diabetic-like state
3. Coffee Drinking in Pregnancy Wont Lead to Sleepless Baby: Study
4. Lower GI problems plague many with rheumatoid arthritis, Mayo Clinic study finds
5. Veggies Like Broccoli, Cabbage May Help Fight Breast Cancer: Study
6. No Added Cancer Risk From Hip Replacement Materials: Study
7. Reported Decline in U.S. Pneumonia Deaths May Be False: Study
8. Early Study Finds Some Promise for Lung Cancer Vaccine
9. Narcissists Often Ace Job Interviews, Study Finds
10. Sexual objectification of female artists in music videos exists regardless of race, MU study finds
11. Soy may alleviate hot flashes in menopause, large-scale study finds
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/6/2016)... ... February 06, 2016 , ... ... , MEDIA ADVISORY: 5000 PERIOPERATIVE NURSES EXPECTED AT AORN SURGICAL CONFERENCE & ... nurses in the world with an estimated 5000 perioperative nurses in attendance ...
(Date:2/5/2016)... SARASOTA, Florida (PRWEB) , ... February 05, 2016 , ... ... an event he has completed every year since it started in 2003. This year, ... attracting the attention of fellow runners and NBA team the Miami Heat. , This ...
(Date:2/5/2016)... Minneapolis, MN (PRWEB) , ... February 05, 2016 , ... ... p.m. at the Day Block Event Center in Minneapolis, Minn. Triumph Over Parkinson’s will ... , Larry Schneiderman, owner of Schneiderman’s Furniture, lives with Parkinson’s disease and is the ...
(Date:2/5/2016)... ... 05, 2016 , ... After years as an active staff surgeon and having ... surgeon Dr. Wayne Carman transitioned to chief of the Division of Plastic Surgery at ... term as chief and began a second three-year term in January of 2016. , ...
(Date:2/5/2016)... ... , ... Regular gym users know the routine: each January, they see a ... treadmills. It’s a predictable trend. After the excesses of November and December, people make ... joining gyms, starting new walking or running routines, or signing up for Zumba. And ...
Breaking Medicine News(10 mins):
(Date:2/5/2016)... York , February 5, 2016 ... Transparency Market Research report states that the global active ... 2014 and is predicted to reach US$185.9 bn by ... of 6.50% from 2014 to 2020. The title of ... Chemical/Biological, Captive/Contract Manufactured, by Geography, and by Therapeutic Area) ...
(Date:2/5/2016)... MELVILLE, N.Y. , Feb. 5, 2016  Henry ... of health care products and services to office-based dental, ... has entered into an agreement to acquire a majority ... dental supplies and equipment in Brazil ... Headquartered in Blumenau, Brazil, Dental Cremer is the dental ...
(Date:2/4/2016)... , Feb. 4, 2016 For hospitals considering ... those already participating in the program, the Health Resources ... to as the , Mega-Guidance , could have significant ... is published in September 2016. Essential Insights ... Service Marketing , summarizes the Mega-Guidance,s key proposed changes, ...
Breaking Medicine Technology: