Conscious Sedation in TAVR Linked to Lower Mortality, Shorter Hospital Stays: TVT Registry

The practice of using conscious sedation instead of general anesthesia for TAVR has increased in recent years and is associated with better survival and less time spent in the hospital, according to an analysis of nationwide data published recently in Circulation.

Senior author Jay Giri, MD, MPH (Hospital of the University of Pennsylvania, Philadelphia), told TCTMD that the study, which captured approximately 90% of all patients who underwent TAVR in the United States during the study period, adds to a limited evidence base on the use of conscious sedation in this setting.

Giri said he and his colleagues tried to adjust for what many people would fear are very disparate populations for comparison, and that in the end they feel “strongly” that the findings are as close as anyone is going to get to a definitive answer without a large and costly randomized trial.

“The additional issue is that the field is moving to adopt [conscious sedation],” he added. “There are many people out there who have been using this method for quite a while now and would feel uncomfortable putting patients under general anesthesia at this point for the sake of a randomized trial, especially after seeing the type of outcomes from a patient-centric perspective that we are getting, let alone from a hospital perspective of reducing length of stay.”

Conscious Sedation Increasingly Being Chosen

Led by Giri’s colleague Matthew C. Hyman, MD, PhD (Hospital of the University of Pennsylvania), the study evaluated data from the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) TVT Registry on 10,997 patients who underwent transfemoral TAVR in the United States between April 2014 and June 2015.

In all, 15.8% underwent TAVR with conscious sedation, with the percentage of cases performed under conscious sedation increasing from 11% to 20% per quarter over the study period (P < 0.001). Additionally, there was in increase in the percentage of sites performing TAVR that reported conscious sedation use.

Among those treated via conscious sedation, 5.9% were converted to general anesthesia. According to Giri, this number is “right in range” with other TAVR case reports.

“The crossover we saw is not trivial—it’s higher than what you would see with PCI, for example,” he said, adding, “It brings up the point that anesthesiologists are still needed on the TAVR team and should still be involved with every case.”

Anesthesiologists are still needed on the TAVR team and should still be involved with every case. Jay Giri

Compared with patients undergoing conscious sedation, those who received general anesthesia were older, less likely to be deemed inoperable or extreme surgical risk, and more likely to receive a balloon-expandable bioprosthesis.

Patients in the conscious sedation group had lower rates of mortality in the hospital (1.5% vs 2.4%; P = 0.01) and at 30 days (2.3% vs 4.0%; P < 0.001), as well as lower rates of the combined endpoint of in-hospital mortality/stroke (3.1% vs 4.1%; P < 0.001) and 30-day mortality/stroke (4.8% vs 6.4%; P < 0.001).

Patients receiving conscious sedation also had a reduction in the need for intraprocedural inotropes (29.3% vs 43.7%; P < 0.001) and a shorter stay in the intensive care unit/hospital (6.0 vs 6.5 days; P < 0.001). However, conscious sedation also was associated with lower procedural success compared with general anesthesia (97.9% vs 98.6%; P < 0.001).

To TCTMD, Giri explained that the researchers also included “falsification endpoints” to strengthen the validity of the analysis. They included vascular complications, bleeding, and new pacemaker/defibrillator implantation—all of which were not significantly different between the anesthesia and conscious sedation groups after adjustment.

Parsing the Mortality Benefit

Although other analyses of TAVR outcomes, including the FRANCE 2 registry, have failed to show a mortality benefit with conscious sedation, Giri said the differences in the STS/ACC TVT Registry outcomes are clear but by no means massive.

“I think I’d be surprised if there was a 3% or 4% mortality difference, but seeing a less than 1% difference makes me feel pretty good that conscious sedation is a least as safe as general anesthesia and raises the question of whether general anesthesia in this patient population carries risks over and above conscious sedation,” Giri said.

“There are a series of steps required in the use of general anesthesia that have the potential to raise risk in patients who are otherwise potentially candidates for both approaches,” he added. “I would never say don’t ever put a patient under general anesthesia for TAVR. . . . But it’s a call to action to groups that have been resistant to get together with their heart team to come up with protocols that enable us to select patients initially that we find we’re comfortable attempting without general anesthesia.” He added that a “deep dive” is needed to determine characteristics that might predict crossover to anesthesia.

During the time frame of the study, only slightly more than 40 institutions in the US were using conscious sedation for TAVR. Giri said it’s likely that “if you studied it now, things would look a little different and there would be a lot more cases being done with conscious sedation in a much more diverse group of institutions.”