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Aortic Stenosis (AS): Managed Surgically by Transcatheter Aortic Valve Replacement (TAVR) – Search Results for “TAVR” on NIH.GOV website, Top 16 pages

Reporter: Aviva Lev-Ari, PhD, RN

UPDATED on 9/24/2018

Sapien 3, CoreValve Evolut R on Par for Aortic Stenosis

Head-to-head trial also shows local, general anesthesia outcomes similar

by Ashley Lyles, Staff Writer, MedPage Today

September 23, 2018

• This article is a collaboration between MedPage Today® and:

  

SAN DIEGO — Transfemoral transcatheter aortic valve replacement (TAVR) with the balloon-expandable Edwards Sapien 3 valve yields the same early outcomes as the self-expanding CoreValve Evolut R, regardless of anesthesia strategy, a two-by-two randomized trial showed.

In the valve comparison, the primary endpoint of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days met criteria for equivalence, with a composite rate of 27.2% with Evolut R and 26.1% with Sapien 3, Holger Thiele, MD, of University Hospital in Leipzig, Germany, reported here at the Transcatheter Cardiovascular Therapeutics meeting.

The researchers also evaluated the effects of anesthesia used during these procedures and found no significant difference. The composite endpoint at 30 days came out 27.0% for local anesthesia and 25.5% for general anesthesia.

“The SOLVE-TAVI trial is the first adequately powered randomized trial comparing local versus general anesthesia in patients with symptomatic aortic valve stenosis undergoing TAVR,” said Thiele in a press release. “Results indicate that local anesthesia is both safe and effective and may be a good option for those patients undergoing TAVR with an intermediate or high surgical risk.”

In the majority of aortic stenosis cases, it doesn’t matter which valve you choose, although there are still some cases, like heavy calcification, when it may be better to choose one valve over the other, noted panel discussant Molly Szerlip, MD, of Baylor Scott & White The Heart Group in McKinney, Texas.

The researchers evaluated 447 patients who were receiving care at German medical centers for severe symptomatic aortic stenosis and were at an intermediate- to high-surgical risk. The patients were randomized to have the Sapien 3 valve or CoreValve Evolut R and to either receive general or local anesthesia with conscious sedation.

The individual valve strategy findings again showed equivalence without superiority between Evolut R and Sapien 3 for mortality (2.8% vs 2.3%) and moderate or severe valve regurgitation (1.9% vs 1.4%). But for stroke Evolut R came out superior (0.5% vs 4.7%), and the two didn’t meet criteria for equivalence on pacemaker implantation (22.9% vs 19.0%, P=0.06 for equivalence).

“The rate of relevant valve regurgitation was low whereas permanent pacemaker rates are still relatively high,” the researchers wrote.

The anesthesia comparison endpoints all met the criteria for equivalence without superiority of general anesthesia over local anesthesia:

• Morality (2.3% vs 2.8%)
• Stroke (2.8% vs 2.4%)
• Myocardial infarction (both 0.5%)
• Infection requiring antibiotics (both 21.0%)
• Acute kidney injury (9.2% vs 8.9%)

SOURCE

https://www.medpagetoday.com/meetingcoverage/tct/75262?xid=nl_mpt_ACC_Reporter_2018-09-23&eun=g5099207d2r

The concept of transcatheter balloon expandable valves was first introduced in the 1980s by a Danish researcher by the name of H. R. Anderson who began testing this idea on pigs. In 2002, Dr. Alain Cribier performed the first successful percutaneous aortic valve replacement on an inoperable patient. The first approval of TAVR for the indication of severe AS in prohibitive risk patients came in 2011. In 2012, the FDA approved TAVR in patients at high surgical risk. In 2015 the indication was expanded to include “valve-in-valve” procedure for failed surgical bioprosthetic valves. Most recently, in 2016 the FDA approved the SAPIEN valve for use in patients with severe AS at intermediate risk.

SOURCE

https://www.ncbi.nlm.nih.gov/pubmed/28613729