Heart Failure, Infective Endocarditis
Conditions
Keywords
IE ; CAH ; AVRpl ; Root replacement; Intervalvular fibrosa
Brief summary
: Evidence suggested that autologous or allogeneic tissue is more suitable to synthetic material in an infected field. Given the unwillingness of some surgeons to use artificial foreign materials, such as conventional mechanical or stent xenograft valve prostheses, cryopreserved aortic homografts (CAH) have been recommended revealing favorable outcomes in aortic valve endocarditis (AVE) surgery (1-5). This aspect is even more evident in cases involving prosthetic valve endocarditis (PVE) and other complex and aggressive lesions involving the aortic root and intervalvular fibrosa with abscess formation. However, most of these reports are fixed on single-arm observational studies without comparing CAH with conventional prostheses. The key question of this study is to establish the difference in treatment failure (death, recurrent aortic valve regurgitation and reoperation), all-cause and cause-specific (cardiac vs noncardiac) mortality, hospitalizations for heart failure during follow-up (structural/non structural valve deterioration, thromboembolism and recurrent endocarditis) in patients who received the CAH vs conventional mechanical or stent xenograft valve prostheses for aortic valve replacement (AVR) secondary to infective endocarditis (IE)
Detailed description
The target population enrolled in the study includes patients with aortic-valve endocarditis at risk of embolization, heart failure and uncontrolled infection undergoing AVR with the use of CAH or conventional mechanical or stent xenograft valve prostheses. Individuals were adequately treated per applicable standards, including for the treatment of infection, LV dysfunction and heart failure. Patients enrolled in the studies were NYHA functional class II, III, or outpatient NYHA IV. Three groups of patients are included in the study. Patients who were managed with CAH, patients who received AVR with conventional stented xenograft and recipients of AVR undergoing surgery with the use of mechanical prostheses.
Interventions
PROCEDURECryopreserved Aortic Homograft
CAH is used for aortic root reconstruction and for repair of mitro-aortic curtain (emicommando procedure) and it is inserted as miniroot . In cases of PVE the infected prosthesis is removed with aggressive debridement of all infected and necrotic tissue. (7)The coronary ostia are prepared for reconstruction of aortic root. In complex valve endocarditis involving aortic and mitral valve a double homograft may be used.Mitro-aortic endocarditis intervalvular fibrosa is largely involved.The abscess cavity is precisely bounded and debrided. and a double homograft is used for the reconstruction (commando procedure
PROCEDUREStented/Non stented xenograft
The insertion of stented/non stented xenograft may be performed using separate or continuos stich with or without teflon pledget. Biological valves may be implated alone or combined with polyester or pericardial patch when reconstruction of annulus is required. In cases of aggressive lesions requiring root and /or intervalvular fibrosa reconstruction the choice of prosthetic bioroot using bioprosthetic valve is considered acceptable alternatives to CAH although it should be guided by the surgeon's experience
PROCEDUREMechanical prostheses
The insertion of conventional mechanical valves may be performed using separate or continuos stich with or without teflon pledget. Mechanical prostheses may be implated alone or combined with polyester or pericardial patch when reconstruction of annulus is required. In cases of aggressive lesions requiring root and /or intervalvular fibrosa reconstruction the choice of prosthetic valved conduit with a mechanical valve is considered acceptable alternatives to CAH although it should be guided by the surgeon's experience
Sponsors
Centre Cardiologique du Nord
Campus Bio-Medico University
Henri Mondor University Hospital
Universita degli Studi di Genova
University of Bristol
Aberdeen Royal Infirmary
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Duke Criteria * Uncontrolled Infection Local abscess Large vegetation False aneurysm, Fistula, Dehiscence of PV * Embolism Large vegetation \>10mm, persistent infection * Heart Failure Involvement of aortic root, intervalvular fibrosa, pulmonary edema, cardiogenic shock
Exclusion criteria
: * Pediatric * Any echocardiographic evidence of absence of IE
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment failure | 10 years] | The primary end point of the study is the degree of treatment failure as assessed by death, recurrent aortic valve regurgitation and reoperation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Mortality | 10 years | The secondary endpoint of the study is the evaluation of overall mortality |
| Cardiac Death | 10 years | The secondary endpoint of the study is the evaluation of cardiac death |
| Non Cardiac Death | 10 years | The secondary endpoint of the study is the evaluation of non cardiac death |
| Hospitalizations for Heart Failure (HF) | 10 years | The secondary endpoint of the study is the evaluation of hospedalization rates for heart failure valve due to structural/non structural valve deterioration, thromboembolism and recurrent endocarditis |
| Major Adverse Cardiac or Cerebrovascular Events (MACCE) | 10 years | Composite of major adverse cardiac or cerebrovascular events (rate of death, stroke, subsequent mitral valve surgery, hospitalization for heart failure, or an increase in New York Heart Association class higher than one), serious adverse events, recurrent aortic regurgitation, quality of life, and rehospitalization. |
| Echocardiographic Parameter Changes (LVEF) | 10 years | Changes from baseline parameters including left ventricular ejection fraction |
| Echocardiographic Parameter Changes (recurrence) | 10 years | Recurrent moderate-to-severe aortic regurgitation after intervention |
| Echocardiographic Parameter Changes (LVEDD) | 10 years | Changes from baseline Left Ventricular End Diastolic Diameter |
| Echocardiographic Parameter Changes (Aortic Root diameter) | 10 years | Changes from baseline aortic root diameter |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORFrancesco Nappi, MD
Centre Cardiologique du Nord
Outcome results
None listed