Local Anesthesia for TAVR Is Safe, Gets Patients Home More Quickly: Meta-analysis

NEW ORLEANS, LA—Going with a minimalist approach that involves local instead of general anesthesia appears to have several advantages for patients undergoing TAVR, according to a new meta-analysis.

In addition to shortening procedures and lengths of stay in the intensive care unit (ICU) and hospital, lighter sedation also seems to lower the risk of needing red blood cell transfusions or treatment with inotropes or vasopressors, Pedro Villablanca, MD (Montefiore Medical Center, New York, NY), observed during his presentation here at the American Heart Association Scientific Sessions 2016.

Those benefits did not come at the cost of worsened clinical outcomes. In fact, 30-day mortality was lower in those receiving local anesthesia (3.7% vs 4.2%; risk ratio 0.76; 95% CI 0.64-0.92).

“This meta-analysis provides preliminary evidence to suggest that local anesthesia can be considered as a potential alternative to general anesthesia for appropriate TAVR patients,” Villablanca said.

He said it would be ideal to have a randomized trial to confirm the findings, although he pointed out that such a study would be difficult to perform at a time when many centers have already started doing most of their TAVR cases with local anesthesia.

In the earlier days of TAVR, the procedure was typically performed under general anesthesia with endotracheal intubation, but in recent years, accumulating evidence has suggested that local anesthesia—as part of a minimalist approach—is feasible and comes with some benefits. These include include less time spent in the hospital, lower costs, and improved short-term outcomes.

Commenting on Villablanca’s study for TCTMD, Santiago Garcia, MD (University of Minnesota, Minneapolis), said the findings are consistent with what has been seen at his center since they switched to performing nearly all TAVRs with conscious sedation instead of general anesthesia about 5 months ago. That was done as part of an overall minimalist approach that includes avoiding use of central lines and Foley catheters, forgoing transesophageal echocardiography (TEE), and discharging patients within 24 to 48 hours.

He said it’s reassuring to see that a simplified approach does not result in more paravalvular leaks or greater contrast use, which could lead to renal failure. “I don’t see any safety signals moving in the wrong direction, and I do see efficacy signals moving in the right direction,” Garcia said.

The meta-analysis does not allow for any definitive conclusions to be made about mortality, he noted, but there are enough advantages to using local anesthesia that a positive impact on mortality is not necessarily required to support the approach.

“If all the safety signals remain the same, I think that the cost/economics of TAVR will be much more favorable if you can then discharge patients within 24 to 48 hours as centers have been doing with conscious sedation,” Garcia said, noting that the hospital stay accounts for about half of the cost of a TAVR procedure.

“Nobody, I think, is expecting a mortality benefit,” he added. “It would be a huge plus if that comes with it, but I think the rationale for going to conscious sedation was not to reduce mortality.”

Selection Bias at Play

To get a better sense of the impact of local versus general anesthesia, Villablanca and his colleagues performed a meta-analysis that included 27 studies and a total of 24,085 patients.

Most outcomes and procedural variables did not differ between the two approaches, with similar rates of stroke, MI, acute kidney injury, vascular complications, major bleeding, permanent pacemaker implantation, paravalvular leak, conduction abnormalities, annular rupture, and fluoroscopy time.

However, patients who received local anesthesia had a shorter average procedure time (90 vs 127 minutes), spent less time in the ICU (1.5 vs 3.0 days) and the hospital (5 vs 9 days), and were less likely to die within 30 days.

Commenting on the study for TCTMD, Tarek Helmy, MD (Saint Louis University, MO), one of the moderators of the session at which Villablanca presented the results, said, “I think the direction the field is moving in is that we are going to use less invasive ways to perform the procedure, [and] this study shows that using local anesthesia actually appears to be safe in a group that is well selected.”

He pointed out, though, that selection bias probably influenced the findings, particularly regarding the lower mortality risk in patients undergoing TAVR with lighter sedation, because general anesthesia is typically given to sicker patients.

“Usually you call the anesthesiologist when you have a very sick patient who is hemodynamically or respiratory-wise unstable and they take care of that part for you as you focus on the procedure,” Helmy said. “And I think this might have been one of the confounding factors.”

Conscious Sedation in Evolving TAVR Landscape

Garcia said it is difficult to say how many TAVRs in the United States are currently being done with conscious sedation because it is center-specific. At his center, lighter sedation is used for all cases, with the exception of those requiring alternative access—subclavian or transapical, for example.

He estimated that about 50% of all TAVR procedures will be done using conscious sedation “very soon,” although the expansion of TAVR to include lower-risk patients and centers just starting to perform the procedure will influence that somewhat.

Currently, Garcia noted, there are about 400 US TAVR programs, which compares with about 1,100 surgical programs. If those surgical programs start performing TAVR, they probably will not start with conscious sedation but instead will use general anesthesia as was done in the earlier days of the procedure, he said.

Another factor that will influence adoption of conscious sedation is whether operators want to retain the ability to perform TEE, which is possible but more difficult when patients are not under general anesthesia, Garcia said. He added that with improvements in technology and low paravalvular leak rates, “I don’t think we’re losing much by eliminating TEE as part of the procedure.” Instead, he said, they use transthoracic echocardiography to check the valve after deployment.

On the other hand, he said, it might make sense to retain the ability to perform TEE if more patients at lower risk or with bicuspid valves start to be treated.