Influence of Original Native Aortic Valve Lesion (Stenosis or Steno-insufficiency vs. Insufficiency) on Post-implant Structural Bioprosthetic Degeneration After Aortic Valve Replacement

N/AEnrolling By InvitationNCT06964035

Maastricht University Medical Center10,000 enrolled

Overview

All patients undergoing elective aortic valve replacement for stenotic aortic valve replacement or aortic valve regurgitation at our institution from 2012 to 2021 who met the inclusion criteria for the study (described in the dedicated session) will be enrolled in the study. These patients will be contacted to provide information about the clinical status, NYHA functional class, possible rehospitalization, possible cardiovascular events and to perform a postoperative echocardiography if not performed in the previous year. Once consent is given, pre-, intra- and post-operative data will be collected in a dedicated, structured, database.

Study Type

OBSERVATIONAL

Enrollment

10,000

Conditions

Aortic Bioprosthesis Degeneration

Interventions

All operations were performed through median longitudinal sternotomy or mini-sternotomy. 8 Intraoperative transesophageal echocardiography (TOE) was used in all patients. Arterial cannulation was central and venous cannulation was achieved with a common two-stage cannula in the right atrium. Left ventricle was vented through the right superior pulmonary vein. In minimally invasive procedures, venous cannulation was achieved percutaneously. Myocardial protection was achieved by administration of cold crystalloid or blood cardioplegia at the surgeon's discretion in an antegrade (indirect or selective) or retrograde fashion. The removal of the calcified cusps and the decalcification of the annulus was performed according to traditional techniques. All the prosthesis were be implanted with supranular technique and 2-0 U-shaped pledgeted sutures.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * \- Age ≥ 18 years; 9 * Patients who underwent isolated aortic and mitral valve replacement for stenosis or regurgitation * Signed informed consent, inclusive of release of medical information. Exclusion Criteria: * \- Aortic and mitral valve replacement associated with surgery of ascending aorta/aortic root; * Aortic and mitral valve replacement associated with other cardiac valve surgery (apart from arrythmia-related ablation or procedures); * Previous cardiac surgery of any kind; * Surgery for acute endocarditis * Surgery for Type A aortic dissection * Participation in another clinical trial that could interfere with the endpoints of this study. * Pregnant or breastfeeding at time of screening.

Outcomes

Primary Outcomes

Prosthetic valve deterioration and degenration

Echocardiographic analisys with multiparametric datas will be used. From quantitative to qualitative.

Time frame: 10-15 years

Secondary Outcomes

Survival

Longitudinal analysis will be used to establish the surival rate at long term.

Time frame: 15 years