Results of surgical ventricular reconstruction in a specialized center and in comparison to the STICH trial: Rationale and study protocol for a patient‐level pooled analysis

Abstract

Introduction: Post-infarction left ventricular remodeling is associated with increased mortality in patients with ischemic heart disease. Surgical ventricular reconstruction (SVR) in addition to coronary artery bypass grafting (CABG) has been proposed to reduce left ventricular volume and improve clinical outcomes. The Surgical Treatment for Ischemic Heart Failure (STICH) trial found that the addition of SVR to CABG did not reduce the rates of death or rehospitalization in the 5 years after surgery compared to CABG alone. Like all randomized trials, STICH has limitations and it has been hypothesized that it may have underestimated the treatment effect of SVR. The aim of this study is to evaluate the results of SVR in one of the largest contemporary single-center series and to compare the results with those of the STICH trial using individual patient's data. Methods and Analysis: Individual data of patients who underwent SVR with or without CABG will be obtained from San Donato University Hospital in Milan. Using multivariable Cox regression analysis, significant prognostic indicators in this cohort will be identified. We will then compare the San Donato cohort to individual patient's data from the SVR arm of Hypothesis 2 of the STICH trial and from both arms of the STICH Extended Study (STICHES). To reduce confounders, propensity score adjustment will be used for this comparison. The primary endpoint will be all-cause mortality. Data will be merged and analyzed independently at Weill Cornell Medicine in New York.

Surgical ventricular reconstruction for ischemic cardiomyopathy—a systematic review and meta-analysis of 7,685 patients

“…Average time from previous myocardial infarction to surgery was 18.2 months (9.4-27.0) and 25% (18-33%) of patients had undergone previous percutaneous coronary intervention (PCI). The mean number of coronary vessels involved was 2.5 (2)(3). Left anterior descending disease was most frequently seen [93% (88-97%)] followed by right coronary [58% (37-80%)], and left circumflex [45% (11-79%)] disease respectively.…”

“…Acute myocardial infarction (AMI) leads to a number of acute and chronic complications that are mediated by various factors. Post-AMI sequelae are characterized by myocardial remodeling-an umbrella term for repair of necrotic heart muscle through thinning, formation of collagen scars, compensatory hypertrophy of non-infarcted myocardium, and eventual ventricular dilation with change in its geometry (2,3). The mechanism underlying remodeling is change at a molecular and cellular level which occurs in response to myocardial necrosis post-AMI.…”

“…Maladaptive remodeling further negatively affects Surgical ventricular reconstruction for ischemic cardiomyopathya systematic review and meta-analysis of 7,685 patients ventricular function and eventually leads to congestive heart failure, the incidence of which is increasing in survivors of acute MI. Current therapies are targeted at preventing and reversing such adverse remodeling (1)(2)(3).…”

“…Surgical ventricular reconstruction (SVR) is an attempt at controlling adverse ventricular remodeling by excluding dyskinetic and scarred ventricle, prevention of further ventricular dilation, and restoration of the geometry of the ventricle (2). This procedure, with its subsequent modifications, was pioneered by Cooley (4), Dor (5) and Jatene (6).…”

“…In 2009, results of the Surgical Treatment for Ischemic Heart Failure (STICH) trial (8) reported greater reduction in ventricular volume with addition of SVR to CABG but no difference in rates of death or hospitalization due to cardiac causes. These results put into question the utility of SVR when combined with CABG and led to a decrease in its popularity (2,9). Being the most consequential trial on SVR efficacy in the last few decades, the STICH trial started conversations regarding the proper place of SVR in treatment of post-MI remodeling and heart failure.…”