Mark Reisman

The future of transcatheter mitral valve interventions: competitive or complementary role of repair vs. replacement?

Transcatheter mitral interventions has been developed to address an unmet clinical need and may be an alternative therapeutic option to surgery with the intent to provide symptomatic and prognostic benefit. Beyond MitraClip therapy, alternative repair technologies are being developed to expand the transcatheter intervention armamentarium. Recently, the feasibility of transcatheter mitral valve implantation in native non-calcified valves has been reported in very high-risk patients. Acknowledging the lack of scientific evidence to date, it is difficult to predict what the ultimate future role of transcatheter mitral valve interventions will be. The purpose of the present report is to review the current state-of-the-art of mitral valve intervention, and to identify the potential future scenarios, which might benefit most from the transcatheter repair and replacement devices under development.

Device Closure of Patent Foramen Ovale After Stroke: Pooled Analysis of Completed Randomized Trials.

BACKGROUND The comparative effectiveness of percutaneous closure of patent foramen ovale (PFO) plus medical therapy versus medical therapy alone for cryptogenic stroke is uncertain. OBJECTIVES The authors performed the first pooled analysis of individual participant data from completed randomized trials comparing PFO closure versus medical therapy in patients with cryptogenic stroke. METHODS The analysis included data on 2 devices (STARFlex [umbrella occluder] [NMT Medical, Inc., Boston, Massachusetts] and Amplatzer PFO Occluder [disc occluder] [AGA Medical/St. Jude Medical, St. Paul, Minnesota]) evaluated in 3 trials. The primary composite outcome was stroke, transient ischemic attack, or death; the secondary outcome was stroke. We used log-rank tests and unadjusted and covariate-adjusted Cox regression models to compare device closure versus medical therapy. RESULTS Among 2,303 patients, closure was not significantly associated with the primary composite outcome. The difference became significant after covariate adjustment (hazard ratio [HR]: 0.68; p = 0.049). For the outcome of stroke, all comparisons were statistically significant, with unadjusted and adjusted HRs of 0.58 (p = 0.043) and 0.58 (p = 0.044), respectively. In analyses limited to the 2 disc occluder device trials, the effect of closure was not significant for the composite outcome, but was for the stroke outcome (unadjusted HR: 0.39; p = 0.013). Subgroup analyses did not identify significant heterogeneity of treatment effects. Atrial fibrillation was more common among closure patients. CONCLUSIONS Among patients with PFO and cryptogenic stroke, closure reduced recurrent stroke and had a statistically significant effect on the composite of stroke, transient ischemic attack, and death in adjusted but not unadjusted analyses.

Multimodality Imaging in the Context of Transcatheter Mitral Valve Replacement: Establishing Consensus Among Modalities and Disciplines

Transcatheter mitral valve implantation (TMVI) represents a promising approach to treating mitral valve regurgitation in patients at increased risk of perioperative mortality. Similar to transcatheter aortic valve replacement (TAVR), TMVI relies on pre- and periprocedural noninvasive imaging. Although these imaging modalities, namely echocardiography, computed tomography, and fluoroscopy, are well established in TAVR, TMVI has entirely different requirements. Approaches and nomenclature need to be standardized given the multiple disciplines involved. Herein we provide an overview of anatomical principles and definitions, a methodology for anatomical quantification, and perioperative guidance.

Rotablator plus stent therapy (rotastent).

Over 400,000 percutaneous transluminal coronary angioplasties (PTCAs) are currently performed annually in the United States. Approximately 10% of these procedures include rotational atherectomy, although the national average rate of stent placements continues to increase in some centers to as high as 75%. The combination of rotational atherectomy and intra-coronary stent placement is between 2% and 7.5% of interventional procedures per year in the United States. This article reviews the existing literature on rotational atherectomy and stent implantation for complex lesions and describes the upcoming prospective, multicenter randomized Stent Implantation, Postrotational Atherectomy (SPORT) trial.

Standardized Definition of Structural Valve Degeneration for Surgical and Transcatheter Bioprosthetic Aortic Valves

Bioprostheses are prone to structural valve degeneration, resulting in limited long-term durability. A significant challenge when comparing the durability of different types of bioprostheses is the lack of a standardized terminology for the definition of a degenerated valve. This issue becomes especially important when we try to compare the degeneration rate of surgically inserted and transcatheter bioprosthetic valves. This document, by the VIVID (Valve-in-Valve International Data), proposes practical and standardized definitions of valve degeneration and provides recommendations for the timing of clinical and imaging follow-up assessments accordingly. Its goal is to improve the quality of research and clinical care for patients with deteriorated bioprostheses by providing objective and strict criteria that can be utilized in future clinical trials. We hope that the adoption of these criteria by both the cardiological and surgical communities will lead to improved comparability and interpretation of durability analyses.

Cardiac Computed Tomography Angiography for Left Atrial Appendage Closure.

Atrial fibrillation is prevalent and percutaneous left atrial appendage (LAA) closure is increasingly performed worldwide. This procedure is technically challenging and the success and procedural complexities depend on anatomy of the LAA and surrounding structures. These are readily depicted on cardiac computed tomography angiography (CCTA), which offers unique imaging planes. CCTA allows not only preplanning anatomic LAA assessment, but can also be used to evaluate for pre-existing LAA thrombus, and done postprocedure for surveillance for device-related thrombus, residual leak, and complications. In this article, we review the practical utility of CCTA for LAA closure.

Anatomy and Function of the Normal and Diseased Mitral Apparatus: Implications for Transcatheter Therapy

Transcatheter mitral valve therapy requires an in-depth understanding of the mitral valve apparatus (annulus, leaflets, chordae tendinae, and papillary muscles) and the impact of various disease states. Adjacent structures (left atrium, left ventricular outflow tract, aortic valve, coronary sinus, and circumflex artery) must also be respected. This article reviews the anatomy and function of the normal and diseased mitral valve apparatus and the implications for catheter-based intervention.

Prevalence and Procedural Outcomes of Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting in Patients with Diabetes and Multivessel Coronary Artery Disease

Abstract  Background: Percutaneous coronary intervention (PCI) is used with increasing frequency in patients with diabetes and multivessel disease. This study investigated evolving revascularization strategies in the State of Washington. Methods: The Clinical Outcomes Assessment Program captures all revascularization in the State of Washington and was used to compare diabetic patients with multivessel disease undergoing first‐time revascularization from 1999 to 2007. Categorical variables were compared with the chi‐squared test and continuous variables were compared with the students t‐test. Results were risk‐adjusted using a logistic regression. Results: A total of 11,602 patients with diabetes and multivessel disease underwent revascularization from 1999 to 2007 and were nearly equally divided between coronary artery bypass grafting (CABG) (51%) and PCI (49%). Patients undergoing CABG had a higher (p < 0.0001) prevalence of congestive heart failure, cerebrovascular disease, peripheral vascular disease, three‐vessel coronary artery disease (CAD), and intraaortic balloon pump insertion, but a lower prevalence of female gender, cardiogenic shock, and emergency procedures. Patients undergoing CABG had more (p < 0.0001) three‐vessel CAD and more complete revascularization (3.7 vs. 1.5 lesions treated). Short‐term risk‐adjusted mortality was equivalent. The prevalence of PCI increased from 34.1% in 1999 to 59.4% in 2007. Conclusions: PCI is applied with increasing frequency to patients with diabetes mellitus (DM) and multivessel disease. PCI is used most commonly in two‐vessel CAD or with acute coronary syndromes with more limited and targeted revascularization. CABG is more commonly applied to extensive disease with more complete revascularization. Both the prevalence and percentage of patients undergoing PCI as primary therapy for multivessel disease with DM is increasing. A multidisciplinary approach may be warranted to ensure optimal outcomes. (J Card Surg 2011;26:1‐8)

A Step-by-Step Guide to Fully Percutaneous Transaxillary Transcatheter Aortic Valve Replacement

ABSTRACT Transcatheter aortic valve replacement (TAVR) is now established as a viable therapy for the treatment of severe aortic stenosis. Though femoral access is used for the majority of cases today, this approach may be limited in cases of insufficient vessel caliber, tortuosity or severe iliofemoral disease. For such scenarios, a transaxillary (TAx) approach is appealing as this vessel appears to be far less frequently affected by atherosclerotic disease, even in the presence of significant iliofemoral disease. Though surgical cut-down has been the traditional method for the TAx approach, there has been a growing clinical experience with successful percutaneous transaxillary access in the setting of TAVR and mechanical circulatory support devices. In this review, we offer a step-by-step guide to TAx TAVR.

Trends and Outcomes of Off-label Use of Transcatheter Aortic Valve Replacement: Insights From the NCDR STS/ACC TVT Registry

Importance Transcatheter aortic valve replacement (TAVR) was approved by the US Food and Drug Administration for severe aortic stenosis in patients who cannot undergo surgery and for patients at high operative risk. Use of TAVR for off-label indications has not been previously reported. Objective To evaluate patterns and adverse outcomes of off-label use of TAVR in US clinical practice. Design, Setting and Participants Patients receiving commercially funded TAVR in the United States are included in the Transcatheter Valve Therapy Registry. A total of 23 847 patients from 328 sites performing TAVR between November 9, 2011, and September 30, 2014, were assessed for this study. Off-label TAVR was defined as TAVR in patients with known bicuspid valve, moderate aortic stenosis, severe mitral regurgitation, severe aortic regurgitation, or subaortic stenosis. Data were linked with the Centers for Medicare & Medicaid Services for 15 397 patients to evaluate 30-day and 1-year outcomes. Exposure Off-label use of TAVR. Main Outcomes and Measures Frequency of off-label TAVR use and the association with in-hospital, 30-day, and 1-year adverse outcomes. Results Among the 23 847 patients in the study (11 876 women and 11 971 men; median age, 84 years [interquartile range, 78-88 years]), off-label TAVR was used in 2272 patients (9.5%). In-hospital mortality was higher among patients receiving off-label TAVR than those receiving on-label TAVR (6.3% vs 4.7%; P < .001), as was 30-day mortality (8.5% vs 6.1%; P < .001) and 1-year mortality (25.6% vs 22.1%; P = .001). Adjusted 30-day mortality was higher in the off-label group (hazard ratio, 1.27; 95% CI, 1.04-1.55; P = .02), while adjusted 1-year mortality was similar in the 2 groups (hazard ratio, 1.11; 95% CI, 0.98-1.25; P = .11). The median rate of off-label TAVR use per hospital was 6.8% (range, 0%-34.7%; interquartile range, 3.4%-12.1%), with hospitals in the highest tertile of off-label use associated with increased 30-day adverse cardiovascular events compared with the lowest tertile. However, this difference was not observed in adjusted 30-day or 1-year outcomes. Conclusions and Relevance Approximately 1 in 10 patients in the United States have received TAVR for an off-label indication. After adjustment, 1-year mortality was similar in these patients to that in patients who received TAVR for an on-label indication. These results reinforce the need for additional research on the efficacy of off-label TAVR use.