Impact of Anesthesia Strategy and Valve Type on Clinical Outcomes After Transcatheter Aortic Valve Replacement.

BACKGROUND: The randomized SOLVE-TAVI (compariSon of secOnd-generation seLf-expandable vs. balloon-expandable Valves and gEneral vs. local anesthesia in Transcatheter Aortic Valve Implantation) trial compared newer-generation self-expanding valves (SEV) and balloon-expandable valves (BEV) as well as local anesthesia with conscious sedation (CS) and general anesthesia (GA) in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). Both strategies showed similar outcomes at 30 days. OBJECTIVES: The purpose of this study was to compare clinical outcomes during 1-year follow-up in the randomized SOLVE-TAVI trial. METHODS: Using a 2 × 2 factorial design 447 intermediate- to high-risk patients with severe, symptomatic aortic stenosis were randomly assigned to transfemoral TAVR using either the SEV (Evolut R, Medtronic Inc., Minneapolis, Minnesota) or the BEV (Sapien 3, Edwards Lifesciences, Irvine, California) as well as CS or GA at 7 sites. RESULTS: In the valve-comparison strategy, rates of the combined endpoint of all-cause mortality, stroke, moderate or severe paravalvular leakage, and permanent pacemaker implantation were similar between the BEV and SEV group (n = 84, 38.3% vs. n = 87, 40.4%; hazard ratio: 0.94; 95% confidence interval: 0.70 to 1.26; p = 0.66) at 1 year. Regarding the anesthesia comparison, the combined endpoint of all-cause mortality, stroke, myocardial infarction, and acute kidney injury occurred with similar rates in the GA and CS groups (n = 61, 25.7% vs. n = 54, 23.8%; hazard ratio: 1.09; 95% confidence interval: 0.76 to 1.57; p = 0.63). CONCLUSIONS: In intermediate- to high-risk patients undergoing transfemoral TAVR, newer-generation SEV and BEV as well as CS and GA showed similar clinical outcomes at 1 year using a combined clinical endpoint. (SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI [SOLVE-TAVI]; NCT02737150).

General Versus Local Anesthesia With Conscious Sedation in Transcatheter Aortic Valve Implantation: The Randomized SOLVE-TAVI Trial.

BACKGROUND: In clinical practice, local anesthesia with conscious sedation (CS) is performed in roughly 50% of patients undergoing transcatheter aortic valve replacement. However, no randomized data assessing the safety and efficacy of CS versus general anesthesia (GA) are available. METHODS: The SOLVE-TAVI (Comparison of Second-Generation Self-Expandable Versus Balloon-Expandable Valves and General Versus Local Anesthesia in Transcatheter Aortic Valve Implantation) trial is a multicenter, open-label, 2×2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement comparing CS versus GA. The primary efficacy end point was powered for equivalence (equivalence margin 10% with significance level 0.05) and consisted of the composite of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury at 30 days. RESULTS: The primary composite end point occurred in 27.2% of CS and 26.4% of GA patients (rate difference, 0.8 [90% CI, -6.2 to 7.8]; Pequivalence=0.015). Event rates for the individual components were as follows: all-cause mortality, 3.2% versus 2.3% (rate difference, 1.0 [90% CI, -2.9 to 4.8]; Pequivalence<0.001); stroke, 2.4% versus 2.8% (rate difference, -0.4 [90% CI, -3.8 to 3.8]; Pequivalence<0.001); myocardial infarction, 0.5% versus 0.0% (rate difference, 0.5 [90% CI, -3.0 to 3.9]; Pequivalence<0.001), infection requiring antibiotics 21.1% versus 22.0% (rate difference, -0.9 [90% CI, -7.5 to 5.7]; Pequivalence=0.011); acute kidney injury, 9.0% versus 9.2% (rate difference, -0.2 [90% CI, -5.2 to 4.8]; Pequivalence=0.0005). There was a lower need for inotropes or vasopressors with CS (62.8%) versus GA (97.3%; rate difference, -34.4 [90% CI, -41.0 to -27.8]). CONCLUSIONS: Among patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement, use of CS compared with GA resulted in similar outcomes for the primary efficacy end point. These findings suggest that CS can be safely applied for transcatheter aortic valve replacement. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02737150.

Fluid Therapy With Gelatin May Have Deleterious Effects on Kidney Function: An Observational Trial.

OBJECTIVE: To explore the effects of fluid therapy with the synthetic colloids hydroxyethyl starch (HES) and gelatin (GEL) on the incidence of acute kidney injury (AKI) and need for renal replacement therapy (RRT) in patients undergoing cardiac surgery. DESIGN: Secondary analysis of a prospective observational study in cardiac surgical patients. DESIGN: University hospital. PARTICIPANTS: The study included 584 elective patients (excluding patients on preoperative dialysis). MEASUREMENTS AND MAIN RESULTS: Anamnestic and surgical core data, hemodynamics, and hemodynamic treatments were recorded intraoperatively and postoperatively. Postoperative kidney dysfunction was graded according to the Acute Kidney Injury Network criteria from perioperative changes in plasma creatinine and urine flow. Statistical analyses were performed descriptively, by logistic and probit regression, omitting inotropic and vasoactive medications as established renal risk factors. The incidence of AKI and new renal replacement therapy was 28.6% and 7.5%, respectively. Patients with AKI were older, had a higher additive Euroscore, lower preoperative glomerular filtration rates and hemoglobin level, and presented with a longer duration of cardiopulmonary bypass and surgery and higher postoperative drainage loss. HES (1 [0-2] units of 500 mL) and GEL (3 [2-5] units of 500 mL) were used in 317 and 563 patients, respectively. Crystalloids were used in all patients (4,560 [4,080-5,042] mL). Patients presenting with AKI or new RRT were treated with significantly higher amounts of GEL. The use of HES and crystalloids did not differ between these groups. Probit regression showed significant dose-response relationships between the amount of infused gelatin and the probability of AKI and new RRT. Probit regression showed significant (p = 0.0001 and 0.0003, respectively) dose-response relationships between the total units of gelatin polysuccinate infused and the probability of AKI and new RRT (Fig 1). Logistic regression revealed a statistically significant odds ratio (OR) of 1.9741 (95% CI: 1.3104-2.9740; p = 0.0011) for an association between the number of gelatin units infused and AKI (grade 1-3) but no direct association between the number of gelatin units administered and new RRT. No association between a decrease in kidney function and the application of HES was observed. CONCLUSIONS: Taking into account the limitations of the small sample size and a low event rate, the nonconsideration of established renal risk factors such as inotropes and vasopressors, and potentially unmeasured confounders, these findings suggested that gelatin solutions may have deleterious effects on renal function in cardiac surgical patients. The adverse clinical effects of HES on kidney function observed in other studies may have been blunted by the restrictive use of this synthetic colloid.