Rihal, Charanjit S.

ObjectivesTo identify number of cases needed to maximize device success and minimize adverse events after transfemoral transcatheter aortic valve replacement (TF‐TAVR), and determine if adverse events were linked to the technical performance learning curve.BackgroundTF‐TAVR is a complex procedure with an incompletely characterized learning curve for clinical outcomes.MethodsFrom 4/2007–2/2012, 1521 patients underwent TF‐TAVR in the PARTNER‐I trial. Outcomes learning curves were defined as number of cases needed to reach a plateau for device success, adverse events, and post‐procedure length of stay. Institutional variation was accounted for by mixed‐model non‐linear techniques, which were also used to identify contribution of the procedure time learning curve to 30‐day major adverse events and length of stay.ResultsEighty percent device success was achieved after 22 cases; major vascular complications fell below 5% after 70 cases and major bleeding below 10% after 25 cases. It took an average of 28 cases to achieve a consistent low risk of 30‐day major adverse events, but institutions entering in the middle of the trial achieved it after about 26. The most significant correlate of 30‐day major adverse events and post‐procedure length of stay was procedure time (P < 0.0001). However, this association was related to patient and unmeasured variables, not the procedure time learning curve (P = 0.6).ConclusionsBy end of trial, a consistent low risk of adverse events was achieved after ∼26 cases. However, these improved results were due to change in patient risk profile; outcomes were not linked to the technical performance learning curve. © 2015 Wiley Periodicals, Inc.

Background— Current risk models for predicting long-term mortality after percutaneous coronary intervention are restricted to all-cause mortality. We sought to develop novel risk models for the prediction of cardiac and noncardiac mortality after percutaneous coronary intervention. Methods and Results— We retrospectively evaluated patients who underwent index percutaneous coronary intervention at Mayo Clinic from 2003 to 2008. Long-term deaths were ascertained through scheduled prospective surveillance. Cause of death was determined via telephone interviews, medical records, and autopsy reports. Fine and Gray extension of Cox proportional hazards models was used to model cause-specific cumulative incidence. Candidate variables and interactions were chosen a priori, without variable selection methods. Resulting models were mapped to an integer-based risk score. The study comprised 6636 patients followed up over a median of 62 months (25th, 75th percentiles: 45, 77 months). There were 1488 deaths, 518 (35%) cardiac, 938 (63%) noncardiac, and 32 (2%) unknown. The 5-year predicted cardiac mortality ranged from 0.6% to 97%, with a corrected c -statistic of 0.82. Risk factors for cardiac death included age, body mass index, ejection fraction, and history of congestive heart failure. The integer score for noncardiac death included age, medicine index, body mass index, current smoker, noncardiac Charlson index and cardiac Charlson index, and accommodated significant age-based interactions for smoking and the 2 Charlson indices. Predicted noncardiac mortality at 5 years ranged from 0.2% to 81%, with a corrected c -statistic of 0.77. Conclusions— We report novel risk models to predict cardiac and noncardiac long-term mortality after percutaneous coronary intervention.

ObjectivesTo assess technical performance learning curves of teams performing transfemoral transcatheter aortic valve replacement (TF‐TAVR).BackgroundTF‐TAVR is a new procedure for treating severe aortic stenosis. The number of cases required for procedural efficiency is unknown.MethodsIn the PARTNER‐I trial, 1,521 patients underwent TF‐TAVR from 4/2007–2/2012. Learning curve analysis of technical performance metrics was performed using institution‐specific patient sequence number, interval between procedures, and institutional trial entry date. Learning curve characteristics were assessed using semi‐parametric and parametric mixed‐effects models.ResultsAs patient sequence number increased, average procedure time decreased from 154 to 85 minutes (P < 0.0001), and fluoroscopy time from 28 to 20 minutes (P < 0.0001). Procedure time plateaued at an average of 83 minutes (range 52–140). Procedure time plateau was dynamic during the course of the trial, averaging 25 cases (range 21–52) by its end. The later institutions enrolled in the trial, the shorter the initial procedure time. During the trial, percutaneous rather than surgical access increased from 7.9% to 69%.ConclusionsTechnical performance learning curves exist for TF‐TAVR; procedural efficiency increased with experience, with concomitant decreases in radiation and contrast media exposure. The number of cases needed to achieve efficiency decreased progressively, with optimal procedural performance reached after approximately 25 cases for late‐entering institutions. Knowledge and experience accumulated by early TF‐TAVR institutions were disseminated, shortening the learning curve of late‐entering institutions. Technological advances resulting from learning during the trial moved the field from initial conservative surgical cut‐down to percutaneous access for most patients. © 2015 Wiley Periodicals, Inc.

Objectives To determine event‐free survival after transcatheter closure of ventricular septal defect (VSD), and to identify predictors of adverse events (AE) in post myocardial infarction VSD (post‐MI VSD) subgroup. Background There are limited data on mid‐term follow‐up after transcatheter VSD closure. Methods Retrospective review of 27 cases of transcatheter VSD closure (post‐MI = 18 and non‐ischemic = 9) performed from 1999 to 2013. We defined AE as death, device embolization, hemolysis requiring blood transfusion, heart block and reintervention. Results In the post‐MI VSD subgroup, mean age and follow‐up was 69 ± 11 and 7.3 ± 7 years, respectively. AE occurred in 8 (44%) patients (death‐3, device embolization‐1, hemolysis‐1, surgical VSD closure‐2, reintervention‐1). Event‐free survival was 56% at 1 month and 5 years, and all AE occurred in the periprocedural period. Cardiogenic shock (HR: 3.21, CI: 1.82–5.41, P = 0.002), and VSD closure in acute phase (HR: 2.14, CI: 1.12–4.31, P = 0.004) were independent predictors of AE. In the non‐ischemic VSD subgroup, mean age and follow‐up was 49 ± 15 and 8.7 ± 8 years, respectively. AE occurred in 3 (33%) patients (late death‐1, surgical VSD closure‐2). For the entire cohort, freedom from death was 89% and 85% at 1 month and 5 years, and event‐free survival was 70% and 61% at 1 month and 5 years. Conclusions Transcatheter closure of post‐MI VSD carries a moderate risk of periprocedural complications but low event rates afterwards. By comparison, device closure of non‐ischemic VSD has lower periprocedural morbidity but some patients continued to experience AE during follow‐up. © 2015 Wiley Periodicals, Inc.

ObjectiveTo describe the effects of percutaneously implanted valve‐in‐valve in the tricuspid position for patients with pre‐existing transvalvular device leads.MethodsIn this case series, we describe implantation of the Melody valve and SAPIEN XT valve within dysfunctional bioprosthetic tricuspid valves in three patients with transvalvular device leads.ResultsIn all cases, the valve was successfully deployed and device lead function remained unchanged. In 1/3 cases with 6‐month follow‐up, device lead parameters remain unchanged and transcatheter valve‐in‐valve function remains satisfactory.ConclusionsTranscatheter tricuspid valve‐in‐valve is feasible in patients with pre‐existing transvalvular devices leads. Further study is required to determine the long‐term clinical implications of this treatment approach. © 2015 Wiley Periodicals, Inc.

This article provides a brief summary of the relevant recommendations and references related to percutaneous mechanical circulatory support. The goal was to provide the clinician with concise, evidence‐based contemporary recommendations, and the supporting documentation to encourage their application. The full text includes disclosure of all relevant relationships with industry for each writing committee member. A fundamental aspect of all expert consensus statements is that these carefully developed, evidence‐based documents can neither encompass all clinical circumstances, nor replace the judgment of individual physicians in management of each patient. The science of medicine is rooted in evidence, and the art of medicine is based on the application of this evidence to the individual patient. This expert consensus statement has adhered to these principles for optimal management of patients requiring percutaneous mechanical circulatory support. © 2015 by The Society for Cardiovascular Angiography and Interventions, The American College of Cardiology Foundation, the Heart Failure Society of America, and The Society of Thoracic Surgeons.