PROMISE: Percutaneous peRipheral cannulatiOn for Minimally-InvaSive Heart Valve surgEry

Study Overview
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Brief Summary
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In addition to conventional heart valve surgery (HVS) via full-sternotomy, which is still the most prevalent therapeutic strategy to adress valvular heart disease (VHD), minimally-invasive approaches evolved as safe alternatives, resulting in lower postoperative ventilation times, transfusion rates and shorter in-hospital stay. Femoral artery cannulation is traditionally performed via surgical cutdown to establish cardiopulmonary bypass during minimally-invasive HVS. To avoid groin incision associated infection and lymphocele formation, and further minimize surgical trauma, the use of percutaneous cannulation including novel endovascular closure devices increases as an alternative but remains to be investigated. The Percutaneous peRipheral cannulatiOn for Minimally-InvaSive heart valve surgEry (PROMISE) registry aims to elucidate the safety, feasibility, and effectiveness of newly developed vascular closure devices during minimally-invasive HVS. Acute intra- and perioperative complications will be evaluated according to modified definitions of the Valve Academic Research Consortium (VARC)-3. In addition, based on the initial results, the comparison of percutaneous cannulation with conventional surgical cut-down techniques is planned.

Official Title
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PROMISE: Percutaneous peRipheral cannulatiOn for Minimally-InvaSive Heart Valve surgEry

Conditions
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Heart Valve Diseases, Mitral Valve Disease, Aortic Valve Disease, Tricuspid Valve Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Retrospective analysis of all patients undergoing minimally-invasive heart valve surgery using novel endovascular closure devices for percutaneous cannulation within 6 high-volume heart valve centres in Germany. Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Access site related vascular complications. | Incidence (number of) of access site related vascular complications, according to modified Valve Academic Research Consortium 3 (VARC 3) criteria. | Date of operation (day 0) untill 30 days after operation (day 30). | 
| All-cause mortality. | Incidence (number of) of death from any cause. | Date of operation (day 0) untill 30 days after operation (day 30). | 
| Cardiovascular mortality. | Incidence (number of) of cardiovascular death, defined as death attributable to myocardial ischemia and infarction, heart failure, cardiac arrest because of other or unknown cause, or cerebrovas-cular accident. | Date of operation (day 0) untill 30 days after operation (day 30). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minimally-invasive heart valve surgery, Percutaneous cannulation, Endovascular closure device