Minimalist Approach to Sedation Improves Early TAVR Outcomes: STS-ACC TVT Registry Analysis

ORLANDO, FL—More and more TAVR cases are being performed with a “lightened up” approach to anesthesia, resulting in better 30-day outcomes, registry data suggest. 

With technological improvements in TAVR, such as decreased sheath profiles and reductions in significant aortic insufficiency, “there’s been a lot of interest in so-called minimalist TAVR, according to lead investigator Jay Giri, MD (Hospital of the University of Pennsylvania, Philadelphia, PA).

Presented at SCAI 2016, the study showed that moderate sedation had no adverse impact on procedural success, which was about 98% in both the moderate sedation and general anesthesia groups. Additionally, in-hospital mortality was lower in the moderate sedation group, length of stay was shorter by nearly a full day, and 30-day mortality as well as death/stroke also were less frequent.

When outcomes were compared in inverse probability of treatment weighted analysis, the reductions in short-term mortality, death and stroke remained robust.

The study involved 10,997 patients from the large, mandatory STS/ACC TVT Registry who underwent femoral TAVR between April 2014 and June 2015. Moderate sedation included conscious sedation or monitored anesthesia care with no incision and no intubation. However, approximately 6% of patients were converted during the procedure from moderate to general anesthesia.

Snapshot of Contemporary TAVR

In a briefing to the media, co-investigator Howard C. Herrmann, MD (Hospital of the University of Pennsylvania, Philadelphia, PA), noted that early in the TAVR experience, nearly all procedures in the United States were done with general anesthesia and guided by transesophageal echocardiography (TEE). But since approximately April 2014, he said, there has been a gradual increase in the proportion of cases—totaling nearly 25% in the last quarter of 2015—being performed with a moderate sedation approach.

“This [study] is a snapshot of what’s happening now in the US,” Herrmann said, adding that moderate sedation “certainly doesn’t impact procedural success, and if anything, it results in a reduction in early and 30-day mortality and other outcomes.”

As to whether the reductions in mortality are attributed solely to the minimalist anesthesia approach or to unknown differences between the groups, Herrmann said they cannot be certain yet. “We’ve calculated that we would need close to 5,000 patients in a randomized trial in order to compare in a prospective fashion and be able to answer that question correctly and absolutely,” he noted. “There are certainly advantages to not having general anesthesia from the standpoint of hemodynamic perturbations, recovery, length of stay, how soon patients can get up out of bed—and all of those play into that, so I can’t say . . . we know that it’s all related to the lack of general anesthesia and the use of sedation.”

Furthermore, Herrmann noted that in his own experience patients prefer a conscious sedation approach, while others prefer to be “out of it for the entire procedure and don’t really want to know what’s happening.”

But there are disadvantages, too, he commented. Most notably, TEE guidance is difficult in conscious sedation patients, so it is infrequently used in those cases. “One could argue that you don’t get quite as good a view of things like paravalvular leaks and early recognition of complications,” Herrmann said.

Questions and Learning Curves

Giri said further research will focus on clinical characteristics that might influence the selection of one form of anesthesia over another in TAVR cases, including choice of valve. They also will be looking more in-depth at the roughly 100 patients who were converted to general anesthesia to better describe this group and the factors that may predict need for a general anesthesia approach.

Panelist Ted Feldman, MD (NorthShore University Health System, Evanston, IL), noted that there is wide variation across the country at the moment in use of conscious sedation for TAVR, with centers such as his performing over 90% of their cases that way, while others “are really just learning how to do it.” At the same time, device and sheath sizes have been changing, he added, “so there’s a lot of interplay of . . . several learning curves here, and it doesn’t take away from the value of the study at all. It makes it even more interesting to see how it changes in the next year.”

Giri pointed out that other factors that need to be considered in future research endeavors on minimalist TAVR are differences in care pathways between institutions that could account for differences in some outcomes.

• Giri J. Moderate vs. general anesthesia for transcatheter aortic valve replacement: an STS/ACC transcatheter valve therapy registry analysis. Presented at: SCAI 2016; May 6, 2016; Orlando, FL.

Disclosures:

• Giri reports grants to his institution from St. Jude Medical, and being co-primary investigator of the PORTICO TAVR trial.

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