Oluseun Alli

Quality of Life Assessment in the Randomized PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) Trial of Patients at Risk for Stroke With Nonvalvular Atrial Fibrillation

OBJECTIVES This study sought to assess quality of life parameters in a subset of patients enrolled in the PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial. BACKGROUND The PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial demonstrated that in patients with nonvalvular atrial fibrillation (AF) and CHADS2 (congestive heart failure, hypertension, age, diabetes mellitus, and prior stroke, transient ischemic attack, or thromboembolism) score ≥1, a left atrial appendage closure device is noninferior to long-term warfarin for stroke prevention. Given this equivalency, quality of life (QOL) indicators are an important metric for evaluating these 2 different strategies. METHODS QOL using the Short-Form 12 Health Survey, version 2, measurement tool was obtained at baseline and 12 months in a subset of 547 patients in the PROTECT AF trial (361 device and 186 warfarin patients). The analysis cohort consisted of patients for whom either paired quality of life data were available after 12 months of follow-up or for patients who died. RESULTS With the device, the total physical score improved in 34.9% and was unchanged in 29.9% versus warfarin in whom 24.7% were improved and 31.7% were unchanged (p = 0.01). Mental health improvement occurred in 33.0% of the device group versus 22.6% in the warfarin group (p = 0.06). There was a significant improvement in QOL in patients randomized to device for total physical score, physical function, and in physical role limitation compared to control. There were significant differences in the change in total physical score among warfarin naive and not-warfarin naive subgroups in the device group compared to control, but larger gains were seen with the warfarin naive subgroup with a 12-month change of 1.3 ± 8.8 versus -3.6 ± 6.7 (p = 0.0004) device compared to warfarin. CONCLUSIONS Patients with nonvalvular AF at risk for stroke treated with left atrial appendage closure have favorable QOL changes at 12 months versus patients treated with warfarin. (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation [WATCHMAN PROTECT]; NCT00129545).

Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER‐I trial: Success and safety

To 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.

Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial: Technical performance.

To assess technical performance learning curves of teams performing transfemoral transcatheter aortic valve replacement (TF‐TAVR).

Percutaneous therapeutic approaches to closure of cardiac pseudoaneurysms.

Cardiac and aortic pseudoaneurysms are rare complications following myocardial infarction or cardiac surgery. They are characterized by a contained cardiac or aortic rupture within surrounding tissue and have a high mortality rate if left untreated. Percutaneous treatment of cardiac pseudoaneurysms might be a feasible treatment option in patients who are at high risk of reoperative surgery. There is limited literature on the outcomes and the approaches to percutaneous treatment of these pseudoaneurysms. We review nine cases of cardiac and aortic pseudoaneurysms and percutaneous techniques for closure. Pseudoaneurysms were categorized anatomically as left ventricular posterior (posterobasal or posterolateral), left ventricular outflow tract, left ventricular apical, and ascending aortic pseudoaneurysms. Two patients with posterior pseudoaneurysms (one posterobasal treated with an Amplatzer Septal Occluder device, and one wide‐mouthed posterolateral pseudoaneurysm which was not closed, are described. We further describe two left ventricular outflow tract pseudoaneurysms treated successfully with percutaneous coil embolization, one left ventricular apical pseudoaneurysm treated with coils, and three ascending aortic pseudoaneurysms treated with a septal occluder device or vascular plug. We review the technical approaches, device selection strategies, outcomes, and complications with these percutaneous treatment options. The size of the pseudoaneurysm dimensions of its neck and relative anatomy, particularly to the coronaries and valves, are critical issues to be addressed before percutaneous treatment of these pseudoaneurysms.

Five-year follow-up of the Sirolimus-Eluting Stents vs Vascular Brachytherapy for Bare Metal In-Stent Restenosis (SISR) trial.

OBJECTIVES The aim of this study was to evaluate the 5-year clinical safety and efficacy outcomes of patients treated for in-stent restenosis of bare-metal stents (BMSs). BACKGROUND The SISR trial is a prospective, randomized trial that compared the safety and efficacy of sirolimus-eluting stent (SES) vs vascular brachytherapy (VBT) for the treatment of BMS in-stent restenosis. METHODS A total of 384 patients with BMS in-stent restenosis were randomized to treatment with SES (n = 259) or VBT (n = 125) and were followed for 5 years. RESULTS At 5 years, the rates of target lesion revascularization (TLR) had narrowed and were nonsignificant between the SES and VBT groups, with TLR rates of 24.7% and 31.2% (95% CI -16.3% to 2.8%, P = .179) respectively. Target vessel failure was 33.6% vs 36.8% (95% CI -13.5% to 6.7% P = .568) for SES compared with VBT. The rate of major adverse cardiac event at 5 years was 34.0% vs 36.8% (95% CI -13.1% to7.1%, P = .648) for the SES compared with VBT. There were no differences between SES and VBT in terms of survival free from TLR (72.9% vs 66.4%, log-rank P = .08) or from target vessel failure (64.4% vs 61.3%, log-rank P = .349). There were no significant differences in the rates of definite/probable stent thrombosis (5.9% vs 2.5%, 95% CI -7.9% to 1.3%, P = .182) between the 2 groups. CONCLUSIONS At a 5-year follow-up, no differences in safety or efficacy outcomes were observed for treatment of BMS restenosis with SES vs VBT. There were no significant differences in survival free from TLR, target vessel revascularization, or major adverse cardiac events between the 2 groups at 5 years. Sirolimus-eluting stent is a viable treatment option compared with VBT for BMS restenosis.

Left Atrial Appendage Occlusion for Stroke Prevention

Atrial fibrillation (AF) remains the most common arrhythmia encountered in clinical practice. One of its more common deleterious effects is the development of thromboembolism leading to stroke. The left atrial appendage (LAA) has been shown to the site of the majority of thrombus formation leading to stroke. Anticoagulation with warfarin has been the treatment of choice for prevention of embolic events. Newer anticoagulants have been developed but they still have the potential side effect of causing major bleeding. Occlusion of the LAA has emerged as an alternative therapeutic approach to medical therapy. The aim of this article is to discuss in detail the role of the LAA in thromboembolism in AF, role of device and surgical therapies, and the current clinical data supporting their use. This is particularly timely in that there is now an approved LAA closure device approved in the US for stroke prevention in patients with nonvalvular AF.

Percutaneous left ventricular assist device with TandemHeart for high-risk percutaneous coronary intervention: the Mayo Clinic experience.

In patients with poor left ventricular function and severe left main or multivessel coronary disease, coronary artery bypass grafting (CABG) surgery has been the preferred therapy. However, a number of these patients are either inoperable or poor surgical candidates due to comorbid conditions and previous cardiac surgical procedures. These patients are generally poor candidates for standard percutaneous coronary intervention (PCI) techniques. A hybrid PCI approach with hemodynamic support may be a viable strategy for these patients. We report our experience using the TandemHeart percutaneous left ventricular assist device during high‐risk PCI.

Successful percutaneous transvenous antegrade mitral valve-in-valve implantation

We report a case of transcatheter valve‐in‐valve therapy performed on an 85‐year‐old man with severe mitral bioprosthetic valve dysfunction. He was a high risk candidate for conventional surgery and he underwent placement of the Melody transcatheter heart valve into the mitral bioprosthesis via the right femoral vein.© 2012 Wiley Periodicals, Inc.

Recurrent dyspnea following multiple ablations for atrial fibrillation explained by the “stiff left atrial syndrome”

We present the case of a patient who underwent repeated ablations for atrial fibrillation and presented with recurrent dyspnea, elevated left atrial pressure with large V waves in the absence of mitral regurgitation. This case provides an example of “stiff left atrial syndrome” as has been described in patients with mitral valve replacement and only recently in patients with radiofrequency ablations for atrial fibrillation.

Left atrial appendage occlusion

Left atrial appendage (LAA) occlusion for stroke and thromboembolism prevention in patients with atrial fibrillation (AF) represents a significant advancement in the field of cardiovascular disease. Prevention and avoidance of the devastating consequences of thromboembolic complications from AF continues to be central in the management of these patients. The role of LAA as a nidus for thrombus formation is well documented. Multiple approaches to exclude the LAA from the circulation either percutaneously or surgically have been described and are undergoing testing. Although pharmacological therapy for stroke prevention remains the cornerstone of treatment, device and surgical exclusion of the LAA have proven to be viable alternatives in carefully selected patients. Even though current evidence show that LAA occlusion is safe and effective, approval and adoption of this strategy has been quite difficult due to paucity of randomised clinical trial data on the risk and benefit ratio, cost effectiveness and the issues of procedural risk as well as longer-term outcome. This review aims to provide an update on the current status of LAA occlusion, specifically looking at interpretation of current clinical data, available techniques and devices, issues with current devices and future direction.