AstraZeneca, Biosensors, and The Medicines Company.

The Portico system (St. Jude Medical, Minneapolis, MN, USA) consists of a self-expanding valve prosthesis and a delivery system designed for transcatheter aortic valve replacement (TAVR). We describe this system, its 10-steps implantation procedure, and provide tips and tricks based on our personal experience with this system.

Background In the GLOBAL LEADERS trial, ticagrelor monotherapy beyond 1 month compared with standard antiplatelet regimens after coronary stent implantation did not improve outcomes at intention‐to‐treat analysis. Considerable differences in treatment adherence between the experimental and control groups may have affected the intention‐to‐treat results. In this reanalysis of the GLOBAL LEADERS trial, we compared the experimental and control treatment strategies in a per‐protocol analysis of patients who did not deviate from the study protocol. Methods and Results Baseline and postrandomization information were used to classify whether and when patients were deviating from the study protocol. With logistic regressions, we derived time‐varying inverse probabilities of nondeviation from protocol to reconstruct the trial population without protocol deviation. The primary end point was a composite of all‐cause mortality or nonfatal Q‐wave myocardial infarction at 2 years. At 2‐year follow‐up, 1103 (13.8%) of 7980 patients in the experimental group and 785 (9.8%) of 7988 patients in the control group qualified as protocol deviators. At per‐protocol analysis, the rate ratio for the primary end point was 0.88 (95% CI, 0.75–1.03; P =0.10) on the basis of 274 versus 325 events in the experimental versus control group. The rate ratio for the key safety end point of major bleeding was 1.00 (95% CI, 0.79–1.26; P =0.99). The per‐protocol and intention‐to‐treat effect estimates were overall consistent. Conclusions Among patients who complied with the study protocol in the GLOBAL LEADERS trial, ticagrelor plus aspirin for 1 month followed by ticagrelor monotherapy was not superior to 1‐year standard dual antiplatelet therapy followed by aspirin alone at 2 years after coronary stenting. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01813435.

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Background: Transcatheter aortic valve implantation (TAVI) has been designed to treat elderly patients with severe aortic stenosis at high risk for surgery; however these patients are also often affected by severe iliac-femoral arteriopathy, rendering the trans-femoral approach unemployable. Methods: All European centres with experience of Corevalve implantation through a direct aortic approach were surveyed. All the 15 centers with 3 or more implants were invited to contribute procedural data and outcomes onto a dedicated database. Results: This multi-centre experience comprises 151 patients treated in the 15 centre in 9 countries in Europe and Israel. The mean age was 80.8Ϯ6.4 years, 46% of patients were female. The mean logistic EuroScore was 26.6Ϯ16; 85% of patients were in NYHA functional class Ն III. Echocardiographic max trans-valvular gradient was 80 mmHg and left ventricle ejection fraction was 50%. Peripheral vascular disease was present in 86% of cases and was the main reason for femoral TAVI exclusion. Fifty four % of patients had coronary artery disease and 28% of the patients had undergone previous coronary artery bypass surgery. The procedure was performed in 62% of cases via a mini-sternotomy and in 58 patients through a right anterior mini-thoracotomy in the 2nd intercostal space. The CoreValve 29 mm was implanted in 50% of the cases. In all patients after valve deployment, the mean aortic gradient immediately dropped to Յ 5 mmHg. Procedural success was achieved in 97% of cases. There were no procedural deaths and 30 day mortality was 8.6%. The incidence of stroke was 3.9% and 7/52 required a new permanent pacemaker 20% of patients. Median post-operative hospitalization was 10 days. Conclusions: Direct aortic access is a feasible approach for TAVI with the selfexpanding Corevalve prosthesis. These initial results with this technique are encouraging given the high risk patient cohort (with a particularly high incidence of concomitant vascular disease) and the fact that this series includes each unit's initial experience and early learning curve with this approach. In our opinion, the direct aortic approach should be considered a viable alternative to the standard transapical technique.