Objectives The aim of this study is to assess the feasibility and clinical outcome of transcatheter aortic valve replacement (TAVR) using aortic valve predilatation (AVPD) with a small, nonocclusive balloon. Background Balloon aortic valvuloplasty (BAV) under rapid pacing is generally performed in TAVR to ensure the passage and sufficient deployment of the prosthesis in the stenotic AV. BAV may cause serious complications, such as left ventricular stunning or cerebrovascular embolism. Methods A cohort of 50 consecutive patients with severe aortic stenosis underwent transfemoral TAVR with the Edwards Sapien 3-heart valve. All patients underwent AVPD with a small, nonocclusive balloon (12 × 60 or 14 × 60 mm) without rapid pacing. Procedural data and clinical outcomes were analyzed. Results The mean age of the cohort was 81 ± 6 years and the mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 13 ± 9. Crossing the AV and prosthesis implantation was successful in all cases. The postprocedural mean AV gradient was 12 ± 5 mmHg. There were no cases of aortic regurgitation ≥ grade 2. No periprocedural stroke occurred. One patient (2%) with chronic atrial fibrillation displayed a transient Wernicke aphasia occurring more than 24 hours after TAVR. Mortality was 0% at 30 days after procedure. Conclusion In TAVR, AVPD with a small, nonocclusive balloon can be safely performed. By avoiding rapid pacing, this technique may be a valid alternative to traditional BAV. Whether or not the use of APVD without rapid pacing translates into less periprocedural complications needs to be assessed in future studies.
Background-Cangrelor is a potent intravenous adenosine diphosphate-receptor antagonist that in the CHAMPION trials reduced the 48-hour and 30-day rates of ischemic events during percutaneous coronary intervention without an increase in severe bleeding. Coronary Intervention) were 3 randomized, double-blind, double-dummy trials in which cangrelor was compared with clopidogrel during percutaneous coronary intervention. The effect of cangrelor on ischemic events and bleeding was analyzed in the subgroup of patients with a history of cerebrovascular events at least 1 year prior to randomization; the Breslow-Day test was used to test for interaction of treatment effect in subgroups with and without such a history. The primary efficacy end point was a composite of death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis at 48 hours. Among 24 910 randomized patients, 1270 patients (5.1%) had a cerebrovascular event >1 year old, including 650 assigned to cangrelor and 620 assigned to clopidogrel. Consistent with the overall trial results, the rate of the primary efficacy end point was 4.3% in the cangrelor group versus 5.3% in the clopidogrel group (odds ratio 0.80; 95% confidence interval 0.48-1.34; P=0.40; P for interaction =0.97), and the rate of GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) severe bleeding was 0.3% in both groups (P=0.97; P for interaction =0.81). Conclusions-Among patients in the CHAMPION trials with a prior cerebrovascular event at least 1 year before the percutaneous coronary intervention, the efficacy and bleeding profile of cangrelor compared with clopidogrel was similar to that in the overall trial. (Circ Cardiovasc Interv. 2017;10:e004380.
Methods and Results-CHAMPION
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