Carlos E. Ruiz

2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease

The medical profession should play a central role in evaluating evidence related to drugs, devices, and procedures for detection, management, and prevention of disease. When properly applied, expert analysis of available data on the benefits and risks of these therapies and procedures can improve

2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines

Jeffrey L. Anderson, MD, FACC, FAHA, Chair , Jonathan L. Halperin, MD, FACC, FAHA, Chair-Elect , Nancy M. Albert, PhD, CCNS, CCRN, FAHA, Biykem Bozkurt, MD, PhD, FACC, FAHA, Ralph G. Brindis, MD, MPH, MACC, Mark A. Creager, MD, FACC, FAHA[§§][1], Lesley H. Curtis, PhD, FAHA, David DeMets, PhD,

2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines

Jeffrey L. Anderson, MD, FACC, FAHA, Chair , Jonathan L. Halperin, MD, FACC, FAHA, Chair-Elect , Nancy M. Albert, PhD, CCNS, CCRN, FAHA, Biykem Bozkurt, MD, PhD, FACC, FAHA, Ralph G. Brindis, MD, MPH, MACC, Mark A. Creager, MD, FACC, FAHA[§§][1], Lesley H. Curtis, PhD, FAHA, David DeMets, PhD,

2016 Annual Report of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

BACKGROUNDnThe Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry captures all procedures with Food and Drug Administration-approved transcatheter valve devices performed in the United States, and is mandated as a condition of reimbursement by the Centers for Medicaid & Medicare Services.nnnOBJECTIVESnThis annual report focuses on patient characteristics, trends, and outcomes of transcatheter aortic and mitral valve catheter-based valve procedures in the United States.nnnMETHODSnWe reviewed data for all patients receiving commercially approved devices from 2012 through December 31, 2015, that are entered in the TVT Registry.nnnRESULTSnThe 54,782 patients with transcatheter aortic valve replacement demonstrated decreases in expected risk of 30-day operative mortality (STS Predicted Risk of Mortality [PROM]) of 7% to 6% and transcatheter aortic valve replacement PROM (TVT PROM) of 4% to 3% (both pxa0< 0.0001) from 2012 to 2015. Observed in-hospital mortality decreased from 5.7% to 2.9%, and 1-year mortality decreased from 25.8% to 21.6%. However, 30-day post-procedure pacemaker insertion increased from 8.8% in 2013 to 12.0% in 2015. The 2,556 patients who underwent transcatheter mitral leaflet clip in 2015 were similar to patients from 2013 to 2014, with hospital mortality of 2% and with mitral regurgitation reduced to gradexa0≤2 in 87% of patients (pxa0< 0.0001). The 349 patients who underwent mitral valve-in-valve and mitral valve-in-ring procedures were high risk, with an STS PROM for mitral valve replacement of 11%. Thexa0observed hospital mortality was 7.2%, and 30-day post-procedure mortality was 8.5%.nnnCONCLUSIONSnThe TVT Registry is an innovative registry that that monitors quality, patient safety and trends for these rapidly evolving new technologies.

SCAI/AATS/ACC/STS operator and institutional requirements for transcatheter valve repair and replacement. Part II. mitral valve

With the evolution of transcatheter valve replacement, an important opportunity has arisen for cardiologists and surgeons to collaborate in identifying the criteria for performing these procedures. Therefore, Additional Supporting Information may be found inxa0the online version of this article. The

Thirty-Day Readmissions After Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis in New York State

Background—Several studies have compared short-term and medium-term mortality rates for patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR), but no studies have compared short-term readmission rates for the 2 procedures. Methods and Results—New York’s Cardiac Surgery Reporting System was used to propensity match 617 TAVI and 1981 SAVR patients using numerous patient risk factors contained in the registry. The 389 propensity-matched pairs were then used to analyze differences in readmission rates between the 2 groups. TAVI and SAVR readmission rates were also compared for patients with a history of congestive heart failure and for patients aged ≥80. Also, reasons for readmission for TAVI and SAVR patients were examined and compared. Readmission rates were not statistically different for all propensity-matched TAVI and SAVR patients (respective rates, 18.8% and 19.3%; P=0.86). After further adjustment using a logistic regression model, there was still no significant difference (adjusted odds ratio, 0.97; 95% confidence interval [0.68–1.39]). For patients aged ≥80, the 30-day readmission rates were 19.9% and 22.0% (P=0.59), and when further adjusted using the logistic regression model, adjusted odds ratio=0.89 (0.55–1.45). For patients with a history of congestive heart failure, the respective rates were 22.8% and 20.4% (P=0.56), and with further adjustment, adjusted odds ratio became 1.15 (0.72–1.82). Conclusions—There are no statistically significant differences between TAVI and SAVR patients in short-term readmission rates.

Systematic CT Methodology for the Evaluation of Subclinical Leaflet Thrombosis

Subclinical leaflet thrombosis was recently described in a randomized trial of transcatheter aortic valve replacement. It was subsequently demonstrated in a series of registries that this was a commonly observed imaging finding seen in all transcatheter and surgical bioprostheses. The phenomenon has aroused considerable interest due to the as-yet-undefined risk for later clinical events and the possibility of pharmacological intervention with anticoagulation. Subclinical leaflet thrombosis is easily detected noninvasively by technically suitable computed tomography (CT) with a high degree of concordance to transesophageal echocardiography findings. The CT hallmarks were noted to be hypoattenuated leaflet thickening (HALT) associated with reduced leaflet motion (RELM). The combination of HALT and RELM signified hypoattenuation affecting motion, the standardized imaging endpoint used. This paper describes the systematic CT evaluation methodology that was devised during the Portico trial investigation and U.S. Food and Drug Administration submission; it also highlights the need for an ongoing discussion among experts to enable, with the help of the Valvexa0Academic Research Consortium, standardization of reporting of this imaging finding to cater to the present and future needs of clinical trials.

Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis: An Expert Statement

The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance withxa0VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortiumxa0provides recommendations for assessment of diseasexa0severity, data collection, and endpoint definitions. Future research in the field is warranted.

Utilization and 1-Year Mortality for Transcatheter Aortic Valve Replacement and Surgical Aortic Valve Replacement in New York Patients With Aortic Stenosis: 2011 to 2012.

OBJECTIVESnThe purpose of this study was to investigate changes in the use of transcatheter aortic valve replacement (TAVR) relative to surgical aortic valve replacement (SAVR) and to examine relative 1-year TAVR and SAVR outcomes in 2011 to 2012 in a population-based setting.nnnBACKGROUNDnTAVR has become a popular option for patients with severe aortic stenosis, particularly for higher-risk patients.nnnMETHODSnNew Yorks Cardiac Surgery Reporting System was used to identify TAVR and SAVR volumes and to propensity match TAVR and SAVR patients using numerous patient risk factors contained in the registry to compare 1-year mortality rates. Mortality rates were also compared for different levels of patient risk.nnnRESULTSnThe total number of aortic valve replacement patients increased from 2,291 in 2011 to 2,899 in 2012, an increase of 27%. The volume of SAVR patients increased by 7.1% from 1,994 to 2,135 and the volume of TAVR patients increased 157% from 297 to 764. The percentage of SAVR patients that were at higher risk (≥3% New York State [NYS] score, equivalent to a Society of Thoracic Surgeons score of about 8%) decreased from 27% to 23%, and the percentage of TAVR patients that were at higher risk decreased from 83% to 76%. There was no significant difference in 1-year mortality between TAVR and SAVR patients (15.6% vs. 13.1%; hazard ratio [HR]: 1.30 [95% confidence interval (CI): 0.89 to 1.92]). There were no differences among patients with NYS score <3% (12.5% vs. 10.2%; HR: 1.42 [95% CI: 0.68 to 2.97]) or among patients with NYS score ≥3% (17.1% vs. 14.5%; HR: 1.27 [95% CI: 0.81 to 1.98]).nnnCONCLUSIONSnTAVR has assumed a much larger share of all aortic valve replacements for severe aortic stenosis, and the average level of pre-procedural risk has decreased substantially. There are no differences between 1-year mortality rates for TAVR and SAVR patients.

The society for cardiovascular angiography and interventions structural heart disease early career task force survey results: Endorsed by the society for cardiovascular angiography and interventions†

Over the last decade, structural heart disease interventions have emerged as a new field in interventional cardiology. Currently, the Accreditation Council for Graduate Medical Education accredited interventional cardiology fellowship programs in the United States provide high‐quality and well established training curriculum in coronary and peripheral interventions, but training in structural interventions remains in its infancy. The current survey seeks to collect relevant information and assess the opinion of interventional cardiology program directors in ACGME‐accredited institutions that are actively involved in structural interventional training. Our study describes the actual number of structural procedures performed by interventional cardiology fellows in ACGME‐accredited programs, the form of the structural training today and the suggestions from program directors who are actively trying to integrate structural training in the interventional cardiology fellowship programs.