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3 results for “surgical ventricular reconstruction”
New Designed ePTFE Valved Conduits for Surgical Reconstruction of Right-ventricular Outflow Tract
ClinicalTrials.gov study NCT04152967. IPD Sharing: NO. Countries: 1. Publications: 5.
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
<p>Dataset from Gaudino M, Castelvecchio S, Rahouma M, Robinson NB, Audisio K, Soletti GJ, Garatti A, Benedetto U, Girardi LN, Menicanti L. 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. J Card Surg. 2021 Feb;36(2):689-692. doi: 10.1111/jocs.15315. Epub 2021 Jan 13. PMID: 33438823.</p> <p>Abstract</p> <p><strong>Introduction: </strong>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.</p> <p><strong>Methods and analysis: </strong>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.</p>
Long-term results of surgical ventricular reconstruction and comparison with the Surgical Treatment for Ischemic Heart Failure trial
<p>Gaudino M, Castelvecchio S, Rahouma M, Robinson NB, Audisio K, Soletti GJ, Cancelli G, Tam DY, Garatti A, Benedetto U, Doenst T, Girardi LN, Michler RE, Fremes SE, Velazquez EJ, Menicanti L. Long-term results of surgical ventricular reconstruction and comparison with the Surgical Treatment for Ischemic Heart Failure trial. J Thorac Cardiovasc Surg. 2022 Apr 26:S0022-5223(22)00493-7. doi: 10.1016/j.jtcvs.2022.04.016. Epub ahead of print. PMID: 35599207.</p> <p><strong>Abstract</strong></p> <p><strong>Objective: </strong>The role of surgical ventricular reconstruction (SVR) in patients with ischemic cardiomyopathy is controversial. Observational series and the Surgical Treatment of IsChemic Heart failure (STICH) trial reported contradictory results. SVR is highly dependent on operator experience. The aim of this study is to compare the long-term results of SVR between a high-volume SVR institution and the STICH trial using individual patient data.</p> <p><strong>Methods: </strong>Patients undergoing SVR at San Donato Hospital (Milan) were compared with patients undergoing SVR in STICH (as-treated principle) by inverse probability treatment-weighted Cox regression. The primary outcome was all-cause mortality.</p> <p><strong>Results: </strong>The San Donato cohort included 725 patients, whereas the STICH cohort included 501. Compared with the STICH-SVR cohort, San Donato patients were older (66.0, lower quartile, upper quartile [Q1, Q3: 58.0, 72.0] vs 61.9 [Q1, Q3: 55.1, 68.8], P < .001) and with lower left ventricular end-systolic volume index at baseline (LVESVI: 77.0 [Q1, Q3: 59.0, 97.0] vs 80.8 [Q1, Q3: 58.5, 106.8], P = .02). Propensity score weighting yielded 2 similar cohorts. At 4-year follow-up, mortality was significantly lower in the San Donato cohort compared with the STICH-SVR cohort (adjusted hazard ratio, 0.71; 95% confidence interval, 0.53-0.95; P = .001). Greater postoperative LVESVI was independently associated with mortality (hazard ratio, 1.02; 95% confidence interval, 1.01-1.03). At 4 to 6 months of follow-up, the mean reduction of LVESVI in the San Donato cohort was 39.6%, versus 10.7% in the STICH-SVR cohort (P < .001).</p> <p><strong>Conclusions: </strong>Patients with postinfarction LV remodeling undergoing SVR at a high-volume SVR institution had better long-term results than those reported in the STICH trial, suggesting that a new trial testing the SVR hypothesis may be warranted.</p>
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