Tag Archives: aortic stenosis

In Historic Moment, Transcatheter Aortic Valve Replacement Proven Superior to Surgical AVR

Three years ago after hearing two amazing presentations at the ACC meeting the skeptical cardiologist opined:

These studies suggest to me for the first time that TAVR may ultimately replace SAVR for all patients with severe aortic stenosis, low to high in their risk for surgery.

Clearly, we need ongoing follow up of these patients and more long term data, but as these devices improve and the operators gain more experience it is likely that results will only get better.

This represents a huge paradigm shift in our approach to valvular heart disease.

This morning I watched two more amazing study presentations at the ACC meeting in New Orleans which unequivocally establish the minimally invasive TAVR procedure (which my cardiology colleagues perform here at St. Luke’s) as the treatment of choice for patients who have symptoms related to severe narrowing of their aortic valve (aortic stenosis).

I just published a piece on the presentations for the physician social media site, SERMO which follows:

Since 2015 it’s been clear to me that catheter-based procedures (TAVR) were a better option than open-heart surgical aortic valve replacement for most of my patients with severe symptomatic aortic stenosis who were at high (>8% STS )  and intermediate (>4% STS) risk for surgery.  

Based on continued durability of TAVR results and outstanding results in my own institution, I’ve been advising my low risk patients with severe aortic stenosis that it was only a matter of time before TAVR would become the best option for them.

At the American College of Cardiology Meetings in New Orleans this morning two back to back presentations have confirmed that TAVR should be considered the treatment of choice rather than surgical aortic valve replacement ( SAVR) for most low risk patients with severe symptomatic AS.

This is such a dramatic paradigm shift in the treatment of AS that the Eugene Braunwald (now 90 years old) the first discussant of the presentations after reviewing the history of the treatment of AS, described it as an “historic moment” , one that we will tell our grandchildren that we were present at.

Furthermore, in a display I’ve never seen at an ACC session, the audience spontaneously stood and gave the presenters a standing ovation. 

Both studies were published yesterday in the NEJM (something the presenters indicated was an error) and disappointingly I read the results described in a New York Times article prior to watching the live presentation.

The first presentation was from Martin Leon on the Partner 3 trial which utilizes the Edwards Sapien 3, third generation baloon-expandable valve. The study randomized 1,000 patients to either TAVR  or standard SAVR with a bioprosthetic valve. The primary endpoint was the composite of death from any cause, stroke or re-hospitalization at one year after the procedure. At one year, the primary endpoint occurred in 8.5 percent of the TAVR group compared with 15.1 percent of the surgery group, meeting the requirements for both noninferiority (p<0.001) and superiority of TAVR vs. surgery (p<0.001).

The Kaplan-Meir analysis of the primary endpoint components with TAVR vs. surgery found mortality rates of 1.0 percent vs. 2.5 percent, stroke rates of 1.2 percent vs. 3.1 percent, and rehospitalization rates of 7.3 percent vs. 11.0 percent, respectively. The length of hospital stay was reduced from seven to three days with TAVR.

A cardiac surgeon, Michael Reardon (who I described as cocky and folksy in my 2015 post on TAVR), presented the results of the  EVOLUT  trial which randomized 1,468 patients to TAVR with a self-expanding bioprosthesis compared with surgical replacement. The primary endpoint was the composite of death from any cause or disabling stroke at 24 months. At 24 months, death or disabling stroke occurred in 5.3 percent of the TAVR group compared with 6.7 percent of the surgery group,

At 30 days, TAVR was statistically superior to surgery for the secondary combined endpoint of all-cause mortality or disabling stroke (0.8 vs. 2.6 percent). Patients receiving TAVR had significantly better quality of life and hemodynamics at 30 days.

I concur that these studies represent tremendous data that will drive a paradigm shift in the treatment of AS and anticipate that we will rapidly receive approval to use these two TAVR devices in all patients who meet the entry criteria (note that bicuspid AV was an exclusion but a subsequent presentation at ACC19 suggests that outcomes are similar in bicuspid valve patients to tricuspid valve patients).

Transfemorally Yours,

-ACP

ACC15 Presentations Make Nonsurgical Aortic Valve Replacement Look Very Promising

At the ACC meetings yesterday, several “late-breaking clinical trial” presentations provided substantial reasons to be enthusiastic about transcutaneous aortic valve replacement (TAVR) in comparison to standard surgical AV replacement (SAVR).

Five Year Results of First Generation TAVR Show Durability

Michael Mack, from Baylor, presented the 5 year follow-up of the ground breaking PARTNER trial results  and they were simultaneously published here.

This study randomized high risk surgical patients with severe aortic stenosis to treatment with a balloon-expandable bovine pericardial tissue valve employed by either a transfemoral (2/3) or transapical approach or a standard surgical aortic valve replacement.

There was no difference in death rate at 5 years between TAVR (68%) and SAVR (62%) in this trial of Edwards Lifescience’s first generation Sapien device.

Interestingly, follow up with echocardiography showed durability of  both surgical and catheter-implanted aortic valves with the mean gradient staying at 11 mm Hg and aortic valve areas at around 1.5 cm2.

Two Year Mortality/Stroke Rates Show Superiority of Corevalve TAVR over SAVR

The very next presentation at this session came from another surgeon from Texas named Mike, the cocky and folksy Mike Reardon, on the two year results of a competing technology in the TAVR field.

The Corevalve TAVR device made by Medtronic is self-expandable as opposed to the balloon-expanded Sapien device and Dr. Reardon declared the results with this device so good that they were “unique and provocative”.  Slides of presentation available here.

Indeed, the Corevalve TAVR two year follow up results showed a significantly lower mortality rate for TAVR (22%) versus SAVR (29%) and a LOWER stroke rate for TAVR (11%) versus (17%).

There was no difference in major stroke between the approaches.
TAVR had a lower mortality plus major stroke rate (24%) versus SAVR (32.5%).
These were dramatic results, indicating for the first time that TAVR may be a superior approach for aortic stenosis in patients who are high AND intermediate in their risk for surgery.
In the discussion that followed, Dr. Reardon asserted that TAVR using the Corevalve approach should be considered the preferred approach to high and intermediate surgical risk patients with severe aortic stenosis.

Will TAVR Become The Procedure of Choice for Severe Aortic Stenosis?

These studies suggest to me for the first time that TAVR may ultimately replace SAVR for all patients with severe aortic stenosis, low to high in their risk for surgery.

Clearly, we need ongoing follow up of these patients and more long term data, but as these devices improve and the operators gain more experience it is likely that results will only get better.

This represents a huge paradigm shift in our approach to valvular heart disease.

Skeptically Yours,

ACP