Moderate sedation during TAVI associated with significantly better outcomes

Jay Giri
Jay Giri

Jay Giri (Cardiovascular Medicine Division, Hospital of the University of Pennsylvania, Philadelphia, USA) reported at the annual meeting of the Society for Cardiac Angiography and Interventions (SCAI; 4–7 May, Orlando, USA) that patients who undergo transcatheter aortic valve implantation (TAVI) with moderate sedation have significantly lower rates of mortality and stroke at 30 days compared with patients who undergo TAVI with general anaesthesia.

Giri reported that there has been a move towards more minimally invasive TAVI procedures—“in which physicians are able to insert the new valve through the groin with no incisions at all”—and this has led to discussions about whether or not there is a need for “the full sedation of a patient requiring breathing tube and nonresponsive unconsciousness.” He noted that previous studies have indicated that minimally invasive TAVI (eg. fully percutaneous, no intubation, and no transoesophageal echo) is associated with significantly shorter procedure times, shorter length of stay, and lower hospital costs compared with “standard” TAVI. The aim of the present study was to compare the effectiveness of general anaesthesia with that of moderate sedation and to identify conversion rates.

Using data from the Society of Thoracic Surgeons/American College of Cardiology transcatheter valve therapy registry, Giri and colleagues identified 10,997 patients who had undergone TAVI between April 2014 and June 2015. Of these, 1,737 (about 15.8%) received moderate-sedation. Compared with the patients who received general anaesthesia, the moderately sedated patients were older (82.5 vs. 81.8, respectively; p=0.01) and received a self-expanding valve more frequently (47.1% vs. 38%; p<0.0001). The primary endpoint of the study was the 30-day rate of mortality and second outcomes included procedural success, in-hospital mortality, and the 30-day mortality/stroke rates.

There were no significant differences in procedural success between groups (98.2% for moderate sedation compared with 98.5% for general anaesthesia; p=0.31) and the conversion rate from moderate sedation to general anaesthesia was 5.9%. According to an inverse probability of treated weighted analysis, the rate of 30-day mortality was significantly lower among patients who received moderate sedation: 2.96% vs. 4.01% for general anaesthesia (p<0.001). Additionally, the 30-day rate of mortality/stroke was significantly lower with moderate sedation (4.8% vs. 6.36%, respectively; p<0.001).

Giri commented: “These data show that moderate sedation is both safe and effective and has potential to become the choice approach for TAVI. These results support our hypothesis that moderate sedation can lead to better clinical outcomes and could have significant implications for patient care and for the process of the TAVI procedure.”

He added that he and his colleagues conducted a propensity-matched analysis to predict 30-day mortality after TAVI and this analysis further confirmed that moderate sedation was associated with lower rates of mortality and stroke at 30 days. “While it is nearly impossible to account for all factors that could lead to needing general anaesthesia, the 51 comorbidities and clinical characteristics we were able to account for still brought us to the same outcome—moderate sedation is associated with better clinical outcomes for patients undergoing percutaneous transfemoral TAVI,” Giri noted.

He told Cardiovascular News: “Our recommendation is that centres initially build their experience with moderate sedation in patients that are relatively lower-risk in order to gain a comfort level with the technique. Over time, the grand majority of transfemoral cases can be approached with moderate sedation.”