Vinay Badhwar

2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation

During the past three decades, catheter and surgical ablation of atrial fibrillation (AF) have evolved from investigational procedures to their current role as effective treatment options for patients with AF. Surgical ablation of AF, using either standard, minimally invasive, or hybrid techniques, is available in most major hospitals throughout the world. Catheter ablation of AF is even more widely available, and is now the most commonly performed catheter ablation procedure. In 2007, an initial Consensus Statement on Catheter and Surgical AF Ablation was developed as a joint effort of the Heart Rhythm Society (HRS), the European Heart Rhythm Association (EHRA), and the European Cardiac Arrhythmia Society (ECAS).1 The 2007 document was also developed in collaboration with the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC). This Consensus Statement on Catheter and Surgical AF Ablation was rewritten in 2012 to reflect the many advances in AF ablation that had occurred in the interim.2 The rate of advancement in the tools, techniques, and outcomes of AF ablation continue to increase as enormous research efforts are focused on the mechanisms, outcomes, and treatment of AF. For this reason, the HRS initiated an effort to rewrite and update this Consensus Statement. Reflecting both the worldwide importance of AF, as well as the worldwide performance of AF ablation, this document is the result of a joint partnership between the HRS, EHRA, ECAS, the Asia Pacific Heart Rhythm Society (APHRS), and the Latin American Society of Cardiac Stimulation and Electrophysiology (Sociedad Latinoamericana de Estimulacion Cardiaca y Electrofisiologia [SOLAECE]). The purpose of this 2017 Consensus Statement is to provide a state-of-the-art review of the field of catheter and surgical ablation of AF and to report the findings of a writing group, convened by these five international societies. The writing group is charged with defining the indications, techniques, and outcomes of AF ablation procedures. Included within this document are recommendations pertinent to the design of clinical trials in the field of AF ablation and the reporting of outcomes, including definitions relevant to this topic. The writing group is composed of 60 experts representing 11 organizations: HRS, EHRA, ECAS, APHRS, SOLAECE, STS, ACC, American Heart Association (AHA), Canadian Heart Rhythm Society (CHRS), Japanese Heart Rhythm Society (JHRS), and Brazilian Society of Cardiac Arrhythmias (Sociedade Brasileira de Arritmias Cardiacas [SOBRAC]). All the members of the writing group, as well as peer reviewers of the document, have provided disclosure statements for all relationships that might be perceived as real or potential conflicts of interest. All author and peer reviewer disclosure information is provided in Appendix A and Appendix B. In writing a consensus document, it is recognized that consensus does not mean that there was complete agreement among all the writing group members. Surveys of the entire writing group were used to identify areas of consensus concerning performance of AF ablation procedures and to develop recommendations concerning the indications for catheter and surgical AF ablation. These recommendations were systematically balloted by the 60 writing group members and were approved by a minimum of 80% of these members. The recommendations were also subject to a 1-month public comment period. Each partnering and collaborating organization then officially reviewed, commented on, edited, and endorsed the final document and recommendations. The grading system for indication of class of evidence level was adapted based on that used by the ACC and the AHA.3,4 It is important to state, however, that this document is not a guideline. The indications for catheter and surgical ablation of AF, as well as recommendations for procedure performance, are presented with a Class and Level of Evidence (LOE) to be consistent with what the reader is familiar with seeing in guideline statements. A Class I recommendation means that the benefits of the AF ablation procedure markedly exceed the risks, and that AF ablation should be performed; a Class IIa recommendation means that the benefits of an AF ablation procedure exceed the risks, and that it is reasonable to perform AF ablation; a Class IIb recommendation means that the benefit of AF ablation is greater or equal to the risks, and that AF ablation may be considered; and a Class III recommendation means that AF ablation is of no proven benefit and is not recommended. The writing group reviewed and ranked evidence supporting current recommendations with the weight of evidence ranked as Level A if the data were derived from high-quality evidence from more than one randomized clinical trial, meta-analyses of high-quality randomized clinical trials, or one or more randomized clinical trials corroborated by high-quality registry studies. The writing group ranked available evidence as Level B-R when there was moderate-quality evidence from one or more randomized clinical trials, or meta-analyses of moderate-quality randomized clinical trials. Level B-NR was used to denote moderate-quality evidence from one or more well-designed, well-executed nonrandomized studies, observational studies, or registry studies. This designation was also used to denote moderate-quality evidence from meta-analyses of such studies. Evidence was ranked as Level C-LD when the primary source of the recommendation was randomized or nonrandomized observational or registry studies with limitations of design or execution, meta-analyses of such studies, or physiological or mechanistic studies of human subjects. Level C-EO was defined as expert opinion based on the clinical experience of the writing group. Despite a large number of authors, the participation of several societies and professional organizations, and the attempts of the group to reflect the current knowledge in the field adequately, this document is not intended as a guideline. Rather, the group would like to refer to the current guidelines on AF management for the purpose of guiding overall AF management strategies.5,6 This consensus document is specifically focused on catheter and surgical ablation of AF, and summarizes the opinion of the writing group members based on an extensive literature review as well as their own experience. It is directed to all health care professionals who are involved in the care of patients with AF, particularly those who are caring for patients who are undergoing, or are being considered for, catheter or surgical ablation procedures for AF, and those involved in research in the field of AF ablation. This statement is not intended to recommend or promote catheter or surgical ablation of AF. Rather, the ultimate judgment regarding care of a particular patient must be made by the health care provider and the patient in light of all the circumstances presented by that patient. The main objective of this document is to improve patient care by providing a foundation of knowledge for those involved with catheter ablation of AF. A second major objective is to provide recommendations for designing clinical trials and reporting outcomes of clinical trials of AF ablation. It is recognized that this field continues to evolve rapidly. As this document was being prepared, further clinical trials of catheter and surgical ablation of AF were under way.

Successful linking of the Society of Thoracic Surgeons adult cardiac surgery database to Centers for Medicare and Medicaid Services Medicare data.

BACKGROUND The Centers for Medicare and Medicaid Services (CMS) Medicare database complements The Society of Thoracic Surgeons (STS) database by providing information about long-term outcomes and cost. This study demonstrates the feasibility of linking STS data to CMS data and examines the penetration, completeness, and representativeness of the STS database. METHODS Using variables common to both STS and CMS databases, STS operations were linked to CMS data for all CMS coronary artery bypass graft surgery (CABG) hospitalizations discharged between 2000 and 2007, inclusive. For each CMS CABG hospitalization, it was determined whether a matching STS record existed. RESULTS Center-level penetration (number of CMS sites with at least one matched STS participant divided by the total number of CMS CABG sites) increased from 45% to 78%. In 2007, 854 of 1,101 CMS CABG sites (78%) were linked to an STS site. Patient-level penetration (number of CMS CABG hospitalizations done at STS sites divided by the total number of CMS CABG hospitalizations) increased from 51% to 84%. In 2007, 94,409 of 111,967 CMS CABG hospitalizations (84%) were at an STS site. Completeness of case inclusion at STS sites (number of CMS CABG cases at STS sites linked to STS records divided by the total number of CMS CABG cases at STS sites) increased from 88% to 97%. In 2007, 88,857 of 91,363 CMS CABG hospitalizations at STS sites (97%) were linked to an STS record. CONCLUSIONS The successful linking of STS and CMS databases demonstrates high and increasing penetration and completeness of the STS database. Linking STS and CMS data will facilitate studying long-term outcomes of cardiothoracic surgery.

The effects of prosthetic cardiac binding and adynamic cardiomyoplasty in a model of dilated cardiomyopathy

OBJECTIVE Because adynamic cardiomyoplasty, or wrapping skeletal muscle around the heart, had been shown to provide a girdling effect and delay progressive ventricular dilatation in heart failure, a similar girdling effect by the much simpler procedure of cardiac binding, using a prosthetic membrane to wrap the heart, was studied and compared with that of adynamic cardiomyoplasty. METHODS Twenty-one dogs were divided into control, adynamic cardiomyoplasty, and cardiac binding groups. Cardiac dimension and hemodynamic studies were carried out before and 4 weeks after rapid pacing at 250 beats/min. For adynamic cardiomyoplasty, the left latissimus dorsi muscle was used for the cardiac wrap; for cardiac binding, a Marlex sheet (C. R. Bard, Inc., Murray Hill, N.J.) was used. Serial two-dimensional echocardiography, right heart catheterization, and in the cardiac binding group, left heart catheterization were performed. RESULTS Four weeks of rapid pacing induced severe heart failure and cardiac dilatation. The magnitude of ventricular dilatation at the end of rapid pacing was less in the cardiac binding group than in the control group and least in the adynamic cardiomyoplasty group. Left ventricular end-diastolic volume, end-systolic volume, and ejection fraction were 82.1 +/- 21.1 ml, 67.1 +/- 16.0 ml, and 17.5% +/- 5.8%, respectively, in the control group; 61.9. +/- 8.1 ml, 44.1 +/- 7.8 ml, and 30.1% +/- 3.6%, respectively, in the cardiac binding group; and 51.8 +/- 8.7 ml, 30.3 +/- 10.4 ml, and 27.0% +/- 4.0%, respectively, in the adynamic cardiomyoplasty group. CONCLUSIONS Both adynamic cardiomyoplasty and cardiac binding reduced cardiac enlargement and functional deterioration after rapid pacing, with adynamic cardiomyoplasty appearing to be more effective, perhaps because of the adaptive capabilities of the skeletal muscle wrap. However, cardiac binding is a simpler and less invasive procedure, which may be useful as an adjunct to prevent or delay progressive ventricular dilatation in heart failure.

Contemporary Real-World Outcomes of Surgical Aortic Valve Replacement in 141,905 Low-Risk, Intermediate-Risk, and High-Risk Patients

BACKGROUND The introduction of transcatheter aortic valve replacement mandates attention to outcomes after surgical aortic valve replacement (SAVR) in low-risk, intermediate-risk, and very high-risk patients. METHODS The study population included 141,905 patients who underwent isolated primary SAVR from 2002 to 2010. Patients were risk-stratified by Society of Thoracic Surgeons (STS) predicted risk of mortality (PROM) <4% (group 1, n = 113,377), 4% to 8% (group 2, n = 19,769), and >8% (group 3, n = 8,759). The majority of patients were considered at low risk (80%), and only 6.2% were categorized as being at high risk. Outcomes were analyzed based on two time periods: 2002 to 2006 (n = 63,754) and 2007 to 2010 (n = 78,151). RESULTS The mean age was 65 years in group 1, 77 in group 2, and 77 in group 3 (p < 0.0001). The median STS PROM for the entire population was 1.84: 1.46% in group 1, 5.24% in group 2, and 11.2% in group 3 (p < 0.0001). Compared with PROM, in-hospital mean mortality was lower than expected in all patients (2.5% vs 2.95%) and when analyzed within risk groups was as follows: group 1 (1.4% vs 1.7%), group 2 (5.1% vs 5.5%), and group 3 (11.8% vs 13.7%) (p < 0.0001). In the most recent surgical era, operative mortality was significantly reduced in group 2 (5.4% vs 6.4%, p = 0.002) and group 3 (11.9% vs 14.4%, p = 0.0004) but not in group 1. CONCLUSIONS Nearly 80% of patients undergoing SAVR have outcomes that are superior to those by the predicted risk models. In the most recent era, early results have further improved in medium-risk and high-risk patients. This large real-world assessment serves as a benchmark for patients with aortic valve stenosis as therapeutic options are further evaluated.

Longitudinal Outcome of Isolated Mitral Repair in Older Patients: Results From 14,604 Procedures Performed From 1991 to 2007

BACKGROUND Mitral valve (MV) repair is performed with less frequency than MV replacement in older persons, with referral often delayed until symptoms are severe. Surgical practice in this population remains inconsistent in the absence of national MV repair outcomes. The goal of this study was to assess durability and longitudinal outcomes after isolated primary MV repair in patients aged 65 years or more. METHODS We linked clinical data from The Society of Thoracic Surgeons adult cardiac surgery database (STS) to longitudinal claims data from the Centers for Medicare and Medicaid Services (CMS). Between January 1991 and December 2007, we identified 14,604 isolated nonemergent primary MV repair operations in STS-CMS data. These were longitudinally examined for mortality, mitral reoperation, and readmissions for heart failure, bleeding, and stroke. Predictors of 5-year death after MV repair were identified using Cox proportional hazard modeling. RESULTS The study cohort had a mean age of 73.3±5.5 years, ejection fraction 54.0%±12.9%; 55.8% (8,148 of 14,604) were female; and 8.4% (1,233 of 14,604) were non-Caucasian. Operative mortality was 2.59% (378 of 14,604). Mean follow-up was 5.9±3.9 years (range, 1.0 to 18.0). Survival during follow-up was 74.9% (10,934 of 14,604). The number of observed events for mitral reoperation, heart failure, bleeding, and stroke were 552 of 14,604 (3.7%), 2,681 of 14,604 (18.4%), 1,051 of 14,604 (7.2%), and 1,131 of 14,604 (7.7%), respectively. The 10-year Kaplan-Meier event rates for mitral reoperation, heart failure, bleeding, and stroke were 6.2%, 30.1%, 15.3%, and 16.4%, respectively. The 10-year actuarial survival of 57.4% was equivalent to the matched US population. CONCLUSIONS Utilizing linked STS and CMS databases, we demonstrate that MV repair is a safe and durable long-term option for older patients. Survival restored to the normal population suggests repair may suppress the longitudinal impact of mitral regurgitation in the elderly and that the practice of delayed referral should be reevaluated. These data provide a contemporary longitudinal benchmark of MV repair outcomes.

The Society of Thoracic Surgeons Mitral Repair/Replacement Composite Score: A Report of The Society of Thoracic Surgeons Quality Measurement Task Force.

BACKGROUND The Society of Thoracic Surgeons (STS) Quality Measurement Task Force is developing a portfolio of composite performance measures for the most commonly performed procedures in adult cardiac surgery. We now describe the fourth in this series, the STS composite measure for mitral valve repair/replacement (MVRR). METHODS We examined all patients undergoing isolated MVRR, with or without concomitant performance of tricuspid valve repair, surgical arrhythmia ablation, or repair of atrial septal defect, between July 1, 2011, and June 30, 2014. In this two-domain model, risk-adjusted mortality and any-or-none major morbidity were combined into a composite score using 3 years of STS data and 95% Bayesian credible intervals to estimate composite scores and star ratings. RESULTS There were 61,201 MVRR patients studied at 867 participant sites. Mitral valve repair was performed in 57.4% (35,114 of 61,201) and mitral valve replacement in 42.6% (26,087 of 61,201). Mortality was 2.9% (1,773 of 61,201), and occurrence of any major morbidity was 17.0% (10,381 of 61,201). The median composite score was 93.2% (interquartile range, 92.3% to 94.2%). Star rating classifications included 23 of 867 (2.6%) 1-star programs (lower-than-expected performance), 795 of 867 (91.7%) 2-star programs (as-expected or average performance), and 49 of 867 (5.7%) 3-star programs (higher-than-expected performance). CONCLUSIONS STS has developed an MVRR composite performance measure that will be used for participant feedback, quality performance assessment and improvement, and voluntary public reporting.

The Society of Thoracic Surgeons Adult Cardiac Surgery Database: 2016 Update on Outcomes and Quality

The Society of Thoracic Surgeons Adult Cardiac Database is one of the longest-standing, largest, and most highly regarded clinical data registries in health care. It serves as the foundation for all quality measurement and improvement activities of The Society of Thoracic Surgeons. This report summarizes current aggregate national outcomes in adult cardiac surgery and reviews database-related activities in the areas of quality measurement and performance improvement.

Noninferiority of Closely Monitored Mechanical Valves to Bioprostheses Overshadowed by Early Mortality Benefit in Younger Patients

BACKGROUND Confidence in bioprosthetic durability without anticoagulation has led to a contemporary trend of offering tissue valves to younger patients. Close monitoring of mechanical valve patients at lower international normalized ratio (INR) thresholds may reduce anticoagulation morbidity. We prospectively compared results of bioprostheses (BP) and a bileaflet mechanical prosthesis (MP) monitored at low INR thresholds. METHODS Patients received an isolated Carpentier-Edwards bovine or Medtronic porcine BP or the On-X MP. INR targets were 2.0 for MP recipients undergoing aortic valve replacement and 2.5 for mitral valve replacement, using point-of-care home monitoring. Operations consecutively performed between September 2003 and August 2007 were propensity matched using logistic regression by preoperative covariates of age, sex, valve position, New York Heart Association class, ejection fraction, atrial fibrillation, and creatinine. RESULTS Of 469 operations consecutively performed, 172 patients were matched for analysis. Mean age was 56.2±9.6 years (range, 24 to 72 years). Median follow-up was 4.0 years (total follow-up, 667.0 patient-years). No late bleeding events occurred. The thromboembolic complication rates per patient-year were 0.77% for MP and 0.78% for BP (p=0.67). There were 9 BP deaths vs 4 MP (2.35% vs 1.41%/patient-year; BP hazard ratio, 0.60; 95% confidence interval, 0.13 to 2.15). Postoperative linearized mortality benefit of MP was observed as early as 5 years, reaching significance at 7.5 years (p=0.04). CONCLUSIONS Patients aged 65 years or younger with MP and closely monitored anticoagulation display noninferiority to BP from bleeding and thromboembolic complications. MP valves begin to confer mortality benefit over BP as early as 7.5 years postoperatively. Because this predates the timeline of typical structural valve degeneration, equipoise is suggested when choosing a BP in a young patient with future expectations of valve-in-valve intervention.

The STS AVR + CABG Composite Score: A Report of the STS Quality Measurement Task Force

BACKGROUND The Society of Thoracic Surgeons (STS) is developing a portfolio of composite performance measures for the most commonly performed adult cardiac procedures. This manuscript describes the third composite measure in this series, aortic valve replacement (AVR) combined with coronary artery bypass grafting surgery (CABG). METHODS We identified all patients in the STS Adult Cardiac Surgery Database who underwent AVR+CABG during recent 3-year (July 1, 2009, through June 30, 2012) and 5-year (July 1, 2007, through June 30, 2012) periods. Variables from the STS risk model for AVR+CABG were used to adjust morbidity and mortality outcomes. Evidence for internal mammary artery use in AVR+CABG was examined. We compared composite measures constructed using 3 or 5 years of outcomes with Bayesian credible intervals of 90%, 95%, or 98%. The final STS AVR+CABG composite performance measure is based on 3 years of data and 95% credible intervals. It includes risk-adjusted mortality and morbidity but not internal mammary artery use. RESULTS Median composite score is 91.0% (interquartile range, 89.5% to 92.2%). There were 2.6% (24 of 915) one-star (lower performing) and 6.5% (59 of 915) three-star (higher performing) programs. Morbidity and mortality decrease monotonically as star ratings increase. The percentage of three-star programs increased substantially among programs that performed more than 150 procedures over 3 years compared with those performing 25 to 50 procedures (32.8% versus 1.6 %). Measure reliability was 0.51. CONCLUSIONS The STS has developed a composite performance measure for AVR+CABG based on 3-year data samples and 95% credible intervals. This composite measure identified 9.1% of STS participants as having higher or lower than expected performance.

Penetration, completeness, and representativeness of the society of thoracic surgeons adult cardiac surgery database

BACKGROUND The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database (ACSD) has been successfully linked to the Centers for Medicare and Medicaid (CMS) Medicare database, thereby facilitating comparative effectiveness research and providing information about long-term follow-up and cost. The present study uses this link to determine contemporary completeness, penetration, and representativeness of the STS ACSD. METHODS Using variables common to both STS and CMS databases, STS operations were linked to CMS data for all CMS coronary artery bypass graft (CABG) surgery hospitalizations discharged between 2000 and 2012, inclusive. For each CMS CABG hospitalization, it was determined whether a matching STS record existed. RESULTS Center-level penetration (number of CMS sites with at least one matched STS participant divided by the total number of CMS CABG sites) increased from 45% in 2000 to 90% in 2012. In 2012, 973 of 1,081 CMS CABG sites (90%) were linked to an STS site. Patient-level penetration (number of CMS CABG hospitalizations done at STS sites divided by the total number of CMS CABG hospitalizations) increased from 51% in 2000 to 94% in 2012. In 2012, 71,634 of 76,072 CMS CABG hospitalizations (94%) occurred at an STS site. Completeness of case inclusion at STS sites (number of CMS CABG cases at STS sites linked to STS records divided by the total number of CMS CABG cases at STS sites) increased from 88% in 2000 to 98% in 2012. In 2012, 69,213 of 70,932 CMS CABG hospitalizations at STS sites (98%) were linked to an STS record. CONCLUSIONS Linkage of STS and CMS databases demonstrates high and increasing penetration and completeness of the STS database. Linking STS and CMS data facilitates studying long-term outcomes and costs of cardiothoracic surgery.