Comparison of Local Versus General Anesthesia Following Transfemoral Transcatheter Self-Expanding Aortic Valve Implantation (from the Transcatheter Valve Therapeutics Registry).

Transfemoral transcatheter aortic valve replacement (TF-TAVR) is mostly performed under general anesthesia (GA) in most US centers. We examined in-hospital and 30-day outcomes in patients who underwent TF-TAVR with a self-expanding bioprosthesis using local anesthesia (LA) or GA. Patients from the Transcatheter Valve Therapeutics Registry who underwent TF-TAVR from January 2014 to June 2016 with LA or GA were evaluated. Propensity matching was performed and procedural and clinical outcomes compared up to 30 days. A total of 11,006 patients were included (GA: 8,239 [74.9%] and LA: 2,767 [25.1%]). After propensity matching (n = 1,988 matched sets), device success was similar (94.5% vs 94.6%, p = 0.905). No differences in in-hospital stroke (2.7% vs 2.3%, p = 0.413) or paravalvular regurgitation grade (p = 0.113) were noted. Fewer LA patients were converted to open heart surgery (0.2% vs 0.6%, p = 0.076) or experienced an in-hospital major vascular complication (0.7% vs 1.4%, p = 0.026). Intensive care unit time (40.1 ± 58.4 vs 50.9 ± 72.1 hours, p < 0.001) and postprocedure length of stay (4.1 ± 3.6 vs 5.0 ± 4.5 days, p < 0.001) were significantly shorter with LA. In-hospital and 30-day all-cause mortality were lower in the LA cohort compared to the GA cohort ([1.1% vs 2.7%, p < 0.001] and [2.1% vs 3.9%, p = 0.001]). In conclusion, in the largest series of self-expanding bioprostheses for TF-TAVR, these propensity-matched cohorts demonstrate that LA is an acceptable alternative to GA with comparable success, lower safety outcomes, complications rates, and in-hospital and 30-day all-cause mortality.

Outcomes in the Randomized CoreValve US Pivotal High Risk Trial in Patients With a Society of Thoracic Surgeons Risk Score of 7% or Less.

Importance: Transcatheter aortic valve replacement (TAVR) is now a well-accepted alternative to surgical AVR (SAVR) for patients with symptomatic aortic stenosis at increased operative risk. There is interest in whether TAVR would benefit patients at lower risk. Objective: The Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) has trended downward in US TAVR trials and the STS/American College of Cardiology Transcatheter Valve Therapy Registry. We hypothesized that if the Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) alone is sufficient to define decreased risk, the contribution to survival based on the degree of invasiveness of the TAVR procedure will decrease, making it more difficult to show improved survival and benefit over SAVR. Design, Setting, and Participants: The CoreValve US Pivotal High Risk Trial was a multicenter, randomized, noninferiority trial. This retrospective analysis evaluated patients who underwent an attempted implant and had an STS PROM of 7% or less. The trial was performed at 45 US sites. Patients had severe aortic stenosis and were at increased surgical risk based on their STS PROM score and other risk factors. Interventions: Eligible patients were randomly assigned (1:1) to self-expanding TAVR or to SAVR. Main Outcomes and Measures: We retrospectively stratified patients by the overall median STS PROM score (7%) and analyzed clinical outcomes and quality of life using the Kansas City Cardiomyopathy Questionnaire in patients with an STS PROM score of 7% or less. Results: The mean (SD) ages were 81.5 (7.6) years for the TAVR group and 81.2 years (6.6) for the SAVR group. A little more than half were men (57.9% in the TAVR group and 55.8% in the SAVR group). Of 750 patients who underwent attempted implantation, 383 (202 TAVR and 181 SAVR) had an STS PROM of 7% or less (median [interquartile range]: TAVR, 5.3% [4.3%-6.1%]; SAVR, 5.3% [4.1%-5.9%]). Two-year all-cause mortality for TAVR vs SAVR was 15.0% (95% CI, 8.9-10.0) vs 26.3% (95% CI, 19.7-33.0) (log rank P = .01). The 2-year rate of stroke for TAVR vs SAVR was 11.3% vs 15.1% (log rank P = .50). Quality of life by the Kansas City Cardiomyopathy Questionnaire summary score showed significant and equivalent increases in both groups at 2 years (mean [SD] TAVR, 20.0 [25.0]; SAVR, 18.6 [23.6]; P = .71; both P < .001 compared with baseline). Medical benefit, defined as alive with a Kansas City Cardiomyopathy Questionnaire summary score of at least 60 and a less than 10-point decrease from baseline, was similar between groups at 2 years (TAVR, 51.0%; SAVR, 44.4%; P = .28). Conclusions and Relevance: Self-expanding TAVR compares favorably with SAVR in high-risk patients with STS PROM scores traditionally considered intermediate risk. Trial Registration: Clinicaltrials.gov Identifier: NCT01240902.

Outcomes before and after initiation of an acute aortic treatment center.

BACKGROUND: Acute aortic syndromes remain life-threatening. Time is of the essence, as mortality rises with increasing time after the acute episode. The aim of this report is to show changes in practice and outcomes after the establishment of an acute aortic treatment center (AATC) to expedite the care of acute aortic syndromes in a major metropolitan area with the belief that "door to intervention time under 90 minutes" reduces mortality and morbidity from acute aortic disease. METHODS: A database of patients admitted with acute aortic disease (Type A and B aortic dissections, acute thoraco-abdominal aortic aneurysms, acute and ruptured abdominal aortic aneurysms) for 1 year prior to initiation (2007) and 1 year after initiation of the pathway (AATC) in 2008 was developed. Comorbidities were scored according to Society of Vascular Surgery criteria. Anatomic and functional outcomes were determined and categorized by Society of Vascular Surgery reporting criteria. Multivariate analysis was performed for categorical outcomes and Cox proportional hazard analyses for time-dependent outcomes. RESULTS: Six hundred twenty-one patients reported with aortic disease to the cardiovascular services; 306 patients were considered to have acute disease. When compared with the year before the AATC was instituted, there was a 30% increase in the total number of admissions and a 25% increase in acute pathology after setting up the AATC (P = .02). There was a two-fold increase in thoracic aortic dissections admitted to the service. Initiation of the treatment pathway resulted in a highly significant 64% reduction in time to definitive therapy (526 ± 557 vs 187 ± 258 minutes, mean ± SD pre-AATC vs AATC; P = .0001). Comorbidity scores were equivalent between the two cohorts. Despite the increase in acuity, mortality (4% vs 6%) and morbidity (41% vs 45%) rates were unchanged, and there was a significant decrease in intensive care unit length of stay (5 vs 4 days, pre-AATC cohort vs the AATC cohort), but total hospital length of stay (11 vs 10 days) was unchanged. There was no correlation between deaths within 30 days and length of stay in the intensive care unit. CONCLUSION: Establishment of a multidisciplinary AATC pathway was associated with a 30% increase in volume, 64% reduction in time to definitive treatment, improved throughput with reduced intensive care unit time, and maintained clinical efficacy despite an increase in acute admissions. These results suggest the concept be further evaluated.