Impact of pre-existing comorbidities on outcomes of patients undergoing surgical aortic valve replacement – rationale and design of the international IMPACT registry

Abstract

Background Degenerative aortic valve disease accounts for 10–20% of all cardiac surgical procedures. The impact of pre-existing comorbidities on the outcome of patients undergoing surgical aortic valve replacement (SAVR) needs further research. Methods The IMPACT registry is a non-interventional, prospective, open-label, multicenter, international registry with a follow-up of 5 years to assess the impact of pre-existing comorbidities of patients undergoing SAVR with the INSPIRIS RESILIA aortic valve on outcomes. IMPACT will be conducted across 25 sites in Austria, Germany, The Netherlands and Switzerland and intends to enroll approximately 500 patients. Patients will be included if they are at least 18 years of age and are scheduled to undergo SAVR with the INSPIRIS RESILIA Aortic Valve with or without concomitant ascending aortic root replacement and/or coronary bypass surgery. The primary objective is to determine all-cause mortality at 1, 3, and 5 years post SAVR. Secondary objectives include cardiac-related and valve-related mortality and structural valve deterioration including hemodynamics and durability, valve performance and further clinical outcomes in the overall study population and in specific patient subgroups characterized by the presence of chronic kidney disease, hypertension, metabolic syndrome and/or chronic inflammation. Discussion IMPACT is a prospective, multicenter European registry, which will provide much-needed data on the impact of pre-existing comorbidities on patient outcomes and prosthetic valve performance, and in particular the performance of the INSPIRIS RESILIA, in a real-world setting. The findings of this study may help to support and expand appropriate patient selection for treatment with bioprostheses. Trial registration ClinicalTrials.gov identifier: NCT04053088.

Impact of Bariatric Surgery on Mortality of Mitral Valve Surgery: A National Analysis

“…14,15 In this study, a higher weighted CCI was associated with an increased risk of in-hospital mortality, even in the unadjusted model. Our finding is aligned with current literature, demonstrating that a greater presence of comorbid conditions is associated with an increased risk of mortality in cardiac surgery patients, 16,17 specifically in patients undergoing MV surgery. 18 When we stratified factors associated with mortality by comorbid conditions, multiple comorbidities increased the risk of mortality, but only endocarditis and DM remained significant when adjusting for other variables.…”

Incidence and predictors of postoperative complications in Sub-Saharan Africa: a systematic review and meta-analysis

“…Patients with comorbidities, such as pre-existing medical conditions or a high severity of illness as indicated by the High-SAS category, are particularly vulnerable to adverse surgical outcomes ( 57 ). Additionally, late presentation of patients, especially those with symptoms of peritonitis upon admission, poses challenges in timely intervention and may exacerbate postoperative morbidity and mortality rates ( 58 ).…”

Mid-term clinical and echocardiographic results of the INSPIRIS RESILIA aortic valve: a retrospective comparison to the Magna Ease

“…Interestingly, this study will include valve calcification assessment by multi-slice computerized tomography. The IMPACT registry will recruit 500 patients across 25 EU sites and will have a particular focus on the impact of pre-existing comorbidities on patient outcomes and bioprosthetic valve performance, more specifically, performance of the INSPIRIS valve at a target FU of 5 years [ 19 ]. Finally, the INSPIRIS, Valve-in-Valve Surveillance Study (INVIVITY; NCT04902053) should provide initial clues to the potential advantages of the VFit technology.…”