Transfemoral transcatheter aortic valve replacement has become the standard of care for older patients with symptomatic aortic stenosis.  While most procedures were initially performed under general anesthesia, based on the assumption that avoiding general anesthesia may improve postinterventional well-being and patient satisfaction, an increasing number of procedures are now performed with local anesthesia plus conscious sedation.  Since this assumption, to the best of our knowledge, has never been formally proven, the primary hypothesis of this analysis was that patient well-being and patient satisfaction would be higher in patients treated with local anesthesia plus conscious sedation in comparison to general anesthesia.

Recently, we have shown in a 2 × 2 factorial design, randomized, multicenter trial in 447 medium- to high-risk patients with aortic stenosis undergoing transcatheter aortic valve replacement that second-generation self-expandable and balloon-expandable valves as well as general anesthesia or local anesthesia with conscious sedation resulted in similar short- and long-term outcomes with respect to a combined primary endpoint including all-cause mortality, stroke, myocardial infarction, acute kidney injury, and infection mandating antibiotic treatment.  The comparison of anesthesia strategies within the 2 × 2 design of the comparison of second-generation self-expandable versus balloon-expandable Valves and general versus local anesthesia in Transcatheter Aortic Valve Implantation (SOLVE-TAVI) trial was powered for equivalence with a margin of 10% at a significance level of 0.05%. Power analysis revealed a necessary sample size of 392 for the combined primary endpoint. The primary endpoint occurred in 27.2% of patients treated with local anesthesia with conscious sedation versus 26.4% in patients treated with general anesthesia (P equivalence = 0.015). 

The study was approved by the ethical committees of all participating centers and was registered at clinicaltrials.gov (NCT02737150; April 13, 2016 by Holger Thiele, M.D.). Preinterventional written informed consent was obtained from all patients. As a part of the protocol, all patients were asked to complete a validated and structured postanesthesia questionnaire  24 to 72 h after the intervention, performed by study personal not involved in anesthesia management. The questionnaire was administered to 380 participants. A total of 61 patients did not recall the immediate postinterventional period, 14 patients had not been treated per protocol (i.e., had undergone a change in anesthesia management either from general anesthesia to local anesthesia with conscious sedation [n = 13] or vice versa [n = 1]), and 10 patients had incomplete surveys, thus leaving 295 patients for the current analysis. We did not perform an a priori sample size calculation. However, 2 × 141 patients would be sufficient to show a 10% difference assuming patient satisfaction with the sedation or anesthesia itself of 85% versus 95% with a power of 80% and α = 0.05. Between-group differences for the four survey expressions were analyzed (Medcalc 20.2, MedCalc Software Ltd, Ostend, Belgium) by chi-square tests without adjustments for multiple comparisons followed by determination of relative risk after dichotomization (“no and little” vs. “moderately and strong”).

The questions and the results of the questionnaire are presented in table 1. There were no significant differences in patient satisfaction with anesthesia or conscious sedation itself during the procedure (fig. 1), or with the care by the anesthesia providers during and immediately after the intervention. A significantly higher number of patients in the general anesthesia group did recall the immediate postinterventional time period only to a minor degree. Evaluation of well-being (feeling comfortable or physically uncomfortable) was not different between groups for the immediate postinterventional period and during the survey period 24 to 72 h after surgery. However, for the immediate postintervention period, significantly more patients in the general anesthesia group claimed to have felt warm or sweaty and to have suffered from hoarseness. In contrast, patients in the local anesthesia with conscious sedation group more frequently noted pain in the surgical area and the site of line insertion for this time period. This suggests a benefit of local anesthesia with conscious sedation in terms of avoidance of unadjusted use of heating blankets and airway manipulation, while general anesthesia may be beneficial in terms of a prolonged analgetic effect in the immediate postinterventional period. No further significant differences were observed between patients undergoing transcatheter aortic valve replacement with general anesthesia or local anesthesia with conscious sedation.

Table 1.

During Awakening from Anesthesia or Sedation and in the Immediate Period Thereafter

During Awakening from Anesthesia or Sedation and in the Immediate Period Thereafter
Fig. 1.
Results of a postinterventional questionnaire on patient satisfaction with the respective mode of anesthesia or sedation performed 24 to 72 h after the intervention in patients who had undergone transcatheter aortic valve replacement with either general anesthesia (n = 146) or local anesthesia with conscious sedation (n = 149). Chi-square test (P = 0.1805) and analyses of proportions (P values depicted in the figure) revealed no significant differences between the modes of anesthesia.

Results of a postinterventional questionnaire on patient satisfaction with the respective mode of anesthesia or sedation performed 24 to 72 h after the intervention in patients who had undergone transcatheter aortic valve replacement with either general anesthesia (n = 146) or local anesthesia with conscious sedation (n = 149). Chi-square test (P = 0.1805) and analyses of proportions (P values depicted in the figure) revealed no significant differences between the modes of anesthesia.

Taking into account the limitation of an increased chance of type 1 error due to multiple testing of the individual items, rendering all conclusions exploratory, the results of this current post hoc analysis of the randomized SOLVE-TAVI trial show overall equivalency in self-evaluated well-being and satisfaction with the procedure between general anesthesia and local anesthesia with conscious sedation in patients undergoing transcatheter aortic valve replacement. This is in line with the neutral results observed in a combined primary endpoint including all-cause mortality and postinterventional morbidity in the main trial. Future work needs to address whether certain patient subtypes can be identified that benefit more from one anesthesia type over the other in terms of patient satisfaction and postinterventional well-being.