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.

Elite athletes as research model: vitamin D insufficiency associates with elevated central blood pressure in professional handball athletes.

PURPOSE: Low vitamin D levels have been associated with elevated blood pressure in the general population. Prospective studies, however, have produced conflicting evidence about the blood pressure-lowering effects of vitamin D supplementation. Cardiorespiratory fitness may modulate the vitamin D-blood pressure association. We therefore examined this association in professional athletes, whose high training load serves as a biological control for physical fitness. METHODS: 50 male professional handball players (age 26 ± 5 years) were examined. We assessed the central aortic pressure parameters using transfer function-based analysis of oscillometrically obtained peripheral arterial waveforms. Serum 25-OH vitamin D concentrations were determined by chemiluminescent immunoassay. The threshold for insufficiency was set at values of < 30 ng/mL. RESULTS: Central blood pressure (cBP) was 98 ± 7/60 ± 10 mmHg. The aortic pulse wave velocity (PWV) was 6.3 ± 1.0 m/s. Nine athletes (18%) displayed insufficient 25-OH vitamin D levels and had a significantly (p < 0.01) higher cBP compared with the 41 (82%) athletes with sufficient 25-OH vitamin D levels (106 ± 5/68 ± 8 vs. 97 ± 7/58 ± 9 mmHg). Central systolic blood pressure (cSBP) in vitamin D-sufficient athletes was significantly lower in comparison to the healthy reference population (97 mmHg vs. 103 mmHg, p < 0.001). This significance of difference was lost in vitamin D-insufficient athletes (106 mmHg vs. 103 mmHg, p = 0.12). CONCLUSION: Significantly raised central systolic and diastolic blood pressure in vitamin D-insufficient elite athletes implicates vitamin D as a potential modifier of vascular functional health.