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Impact of Anesthesia Strategy and Valve Type on Outcomes After TAVR
Quick Takes
- 1-year follow-up of the randomized multicenter SOLVE-TAVI trial showed similar outcomes between patients who underwent transfemoral TAVR with Evolut R vs. Sapien 3 valves.
- Similarly, there was no significant difference in outcomes between patients who underwent TAVR with general anesthesia vs. conscious sedation.
Study Questions:
How do newer-generation valve types and anesthesia strategy impact outcomes after transfemoral transcatheter aortic valve replacement (TAVR) in an intermediate- to high-risk group of patients?
Methods:
This is 1-year follow-up of the prospective randomized multicenter SOLVE-TAVI (compariSon of secOnd-generation seLf-expandable vs. balloon-expandable Valves and gEneral vs. local anesthesia in Transcatheter Aortic Valve Implantation) trial conducted at seven sites in Germany. Intermediate- to high-risk patients with severe, symptomatic aortic stenosis were randomized in 2 x 2 factorial design to transfemoral TAVR with a self-expandable (Evolut R) valve (SEV) or balloon-expandable (Sapien 3) valve (BEV) and to general anesthesia (GA) or conscious sedation (CS). In the valve comparison, the primary endpoint was a composite of all-cause mortality, stroke, moderate or severe paravalvular leak (PVL), and permanent pacemaker (PPM) implantation. In the anesthesia comparison, the primary endpoint was a composite of all-cause mortality, stroke, myocardial infarction (MI), and acute kidney injury (AKI). Quality of life (QOL) was assessed using the EuroQuol-5 questionnaire. Analyses were performed as intention-to-treat. Event analyses accounted for death as a competing risk, and cause-specific hazard ratios (HRs) were compared.
Results:
A total of 447 patients were randomized to four groups: SEV (n = 225), BEV (n = 222), GA (n = 225), and CS (n = 222). Baseline clinical characteristics were well balanced. Mean age was >80 years and mean Society of Thoracic Surgeons (STS) score was 4.7% (interquartile ratio [IQR], 3.0-9.8%).
At 1-year follow-up, there were clinical data for 339 patients (SEV, n = 170; BEV n = 169). There was no significant difference in the composite endpoint (all-cause mortality, stroke, moderate or severe PVL, and PPM) between the BEV and SEV groups (n = 84, 38.3% vs. n = 87, 40.4%; HR, 0.94; 95% confidence interval [CI], 0.70-1.26; p = 0.66). Stroke occurred in 4.4% and was higher in BEV compared to SEV patients (n = 13, 6.1% vs. n = 2, 0.8%; HR, 6.63; 95% CI, 1.50-29.2; p = 0.013). Echo data available for 186 patients showed mean transvalvular gradient was higher in BEV compared to SEV patients (10 mm Hg [IQR, 8-12] vs. 6 mm Hg [IQR, 4-8 mm Hg], p < 0.001). QOL was similar between the two groups.
There was no significant difference in the composite endpoint (all-cause mortality, stroke, MI, and AKI) between the GA and CS groups (n = 61, 25.7% vs. n = 54, 23.8%; HR, 1.09; 95% CI, 0.76-1.57; p = 0.63).
Conclusions:
In a prospective randomized trial studying newer-generation valve types and different anesthesia strategies, there was no significant difference in 1-year composite endpoints between the Evolut R and Sapien 3 valves and between GA or CS strategies.
Perspective:
This study showed acceptable comparable 1-year outcomes of newer-generation valves and different anesthesia strategies in TAVR. The authors point out rates of stroke and other outcomes in this study that differed in comparison to previous randomized trials. This reinforces that no one trial can be used to provide the incidence of complications, as outcomes can change temporally with newer TAVR devices and sheaths, adjunctive devices (e.g., cerebral embolic protection), evolving techniques (e.g., cusp overlap), and expanding implanting centers. However, overall outcomes of TAVR in intermediate- to high-risk patients continue to demonstrate the safety and effectiveness of this procedure in the short-term. Continued follow-up is needed to see the long-term outcomes (5-year and 10-year), especially in the intermediate-risk patient population.
Clinical Topics: Cardiac Surgery, Cardiovascular Care Team, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease
Keywords: Acute Kidney Injury, Anesthesia, General, Anesthesia, Local, Aortic Valve Stenosis, Cardiac Surgical Procedures, Conscious Sedation, Geriatrics, Heart Valve Diseases, Heart Valve Prosthesis, Myocardial Infarction, Pacemaker, Artificial, Quality of Life, Risk Factors, Stroke, Transcatheter Aortic Valve Replacement
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