SOLVE-TAVI: TAVR Safe With Either of Two Valves, Two Types of Anesthesia

Marlene Busko

September 25, 2018

SAN DIEGO — Intermediate- to high-risk patients who underwent transcatheter aortic valve implantation (TAVR) had equally good safety and efficacy outcomes with two types of second-generation valves and two types of anesthesia, researchers report.

SOLVE-TAVI enrolled more than 400 patients with symptomatic aortic stenosis who were scheduled to undergo TAVR at eight centers in Germany and randomized them first to receive a self-expandable CoreValve Evolut R valve (Medtronic) or a balloon-expandable SAPIEN 3 valve (Edwards), and second to undergo local or general anesthesia.

Holger Thiele, MD, from Leipzig University Hospital in Germany, presented the trial results here at Transcatheter Cardiovascular Therapeutics 2018.

The findings show that "the latest-generation valves are technically so well developed that we can use either valve," Thiele told theheart.org | Medscape Cardiology.

Moreover, although "there are still many people, particularly anesthesiologists, who believe that general anesthesia may be safer," this study shows that "local anesthesia is as good as general anesthesia," so it will likely lead to more centers using local anesthesia, "whereas currently it's 50–50."

Invited to comment, B. Hadley Wilson, MD, Sanger Heart & Vascular Institute–Charlotte and the UNC School of Medicine, Chapel Hill, North Carolina, who is spokesperson for the American College of Cardiology, agreed that "now we can feel comfortable that we can pick the best valve that we think will fit our patients and not have [safety] concerns."

The first-generation Edwards SAPIEN valve was associated with more paravalvular leaks and the first-generation CoreValve was associated with more pacemaker usage, he told theheart.org | Medscape Cardiology, "but now, with this second generation, we find that they're equivalent."

The study shows that "we can decide about general or local anesthesia, according to what suits the patient best, but I do think that this suggests that more local anesthesia can be used for these procedures," he said, echoing Thiele. "That may be the most dramatic thing out of this study."

"There would be a huge cost saving" with local anesthesia, he agreed, although surprisingly, hospital stays were 9 days in each group and ICU stays were around 51 hours for each group in the study, whereas US centers typically aim to have moderate- to high-risk patients "home in 48 hours and out of the ICU in 12 to 24 hours."

 

Valve-Related Outcomes

TAVR is becoming a standard strategy for intermediate- to high-risk patients with symptomatic aortic stenosis, Thiele said. Refinements in valve design have led to lower rates of pacemaker implantation, paravalvular leaks, and vascular complications, but head-to-head comparisons of newer-generation valves are still lacking.

Similarly, registry data suggest that when TAVR is performed under local anesthesia, procedure times, ICU stays, and hospital stays are all shorter, and patient morbidity and mortality is reduced. However, this has not been tested in an adequately powered randomized controlled trial.

Thus, SOLVE-TAVI was designed to determine whether safety and efficacy outcomes in TAVR patients randomized to these two second-generation valves and the two types of anesthesia were equivalent.

The trial randomized 447 patients (about half men and half women) with a mean age of 82 years.

This was a high-risk population with a mean STS score of 7.7. Nearly 50% of the patients had atrial fibrillation, about 80% had renal insufficiency, and 50% had pulmonary hypertension. Study outcomes were determined at 30 days.

The primary outcome for valve type was similar in the two groups. Rates of the composite of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation were similar whether patients received the self-expanding of balloon-expandable valve (27.2% vs 26.1%; P = .02 for equivalence).

Mortality in both groups was low, at about 2.5%, even though the patients were mostly high-risk, and moderate/severe valve regurgitation was extremely low, at about 1.7%.  

"Perhaps surprisingly, there was a relatively high pacemaker implantation rate," occurring in about 20% in both groups, Thiele reported.

Patients who received the balloon-expandable valve had a higher rate of stroke (4.7% vs 0.5%), but the study was not powered to examine this outcome.

Anesthesia-Related Outcomes

The primary end point related to anesthesia was also similar in the two groups. Rates of the composite of all-cause mortality, stroke, myocardial infarction (MI), infection requiring antibiotic treatment, and acute kidney injury were similar whether patients underwent local or general anesthesia (27.0% 25.5%; P = .02 for equivalence).

And rates of 30-day mortality were similar with both local and general anesthesia (about 2.5%), as were rates for stroke (about 2.6%), MI (0.5%), acute kidney injury (about 9%), and infection requiring antibiotics (21%).

General anesthesia was associated with a higher rate of catecholamine use — meaning more vasopressor IV agents were used to improve blood pressure, Wilson explained.

Nevertheless, procedure time, valve-related outcomes, and clinical outcomes were similar with both types of anesthesia.

"Some people believe that if you are using TOE (transesophageal/transesophageal echocardiography) during general anesthesia, you can reduce the overall paravalvular leakage rate afterward," Thiele said. But "if you are using the latest-generation valve, it doesn't play a role, so that's the reason we don't need it, if you ask me."

Moving Forward

Currently, "we think of these two valves as overlapping Venn diagrams, [where] the overlap is about 80%," Michael J. Mack, MD, Baylor Plano Research Center, Texas, said during a press conference, "and there's 10% on one side [where] clearly a self-expanding valve is thought to be optimal and, on the other side, 10% where a balloon-expandable valve is thought to be optimal.

"This study reinforces that for 80% of patients, one valve or the other is probably fine, and therefore it's left to the experience of the institution with a particular valve, the comfort level of the operators with a particular valve," Mack said, and then the anatomic characteristics of the patient.

Robert O. Bonow, MD, Northwestern University Feinberg School of Medicine, Chicago, who is editor-in-chief, JAMA Cardiology, was concerned by the pacemaker implantation rate. Going forward, "how many patients at 30 days, 1 year, and 2 years actually still need a pacemaker?" he asked. "Obviously, this is an Achilles heel; it's going to be an issue as we move to younger patients."

Thiele said they plan to look at the reasons the pacemaker was implanted as they continue their analysis of these data.

They also want to determine if there are any patient-specific selection criteria that indicate when to use one valve over the other, Thiele said.

Thiele, Wilson, and Bonow have no relevant financial disclosures. Mack receives grant support from Abbott Vascular, Medtronic, and Edwards Lifescience.

Transcatheter Cardiovascular Therapeutics (TCT) 2018. Presented September 23, 2018.

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