Infective Endocarditis Surgery Using Conventional Prosthetic Valves Versus Cryopreserved Aortic Homograft

Heart Failure Clinical Trial

— IESCOPHO  

Official title:

Cryopreserved Aortic Homograft Versus Conventional Prosthetic Valves for Infective Endocarditis Involving the Aortic Valve : a Propensity Score Matched Analysis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05253469
• Other study ID #: CN-21-24
• Status: Enrolling by invitation
• Start date: February 14, 2022
• Est. completion date: October 30, 2024

Study information

• Verified date: January 2024
• Source: Centre Cardiologique du Nord
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 800
• Est. completion date: October 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial
• Heart Failure
• Infective Endocarditis

Intervention

Procedure:
• Cryopreserved 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
• Stented/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
• Mechanical 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

Locations

Country	Name	City	State
France	Francesco Nappi	Saint Denis

Sponsors (6)

Lead Sponsor	Collaborator
Centre Cardiologique du Nord	Aberdeen Royal Infirmary, Campus Bio-Medico University, Henri Mondor University Hospital, Universita degli Studi di Genova, University of Bristol

Country where clinical trial is conducted

France, 

References & Publications (7)

Kim JB, Ejiofor JI, Yammine M, Camuso JM, Walsh CW, Ando M, Melnitchouk SI, Rawn JD, Leacche M, MacGillivray TE, Cohn LH, Byrne JG, Sundt TM. Are homografts superior to conventional prosthetic valves in the setting of infective endocarditis involving the — View Citation

Nappi F, Nenna A, Petitti T, Spadaccio C, Gambardella I, Lusini M, Chello M, Acar C. Long-term outcome of cryopreserved allograft for aortic valve replacement. J Thorac Cardiovasc Surg. 2018 Oct;156(4):1357-1365.e6. doi: 10.1016/j.jtcvs.2018.04.040. Epub — View Citation

Nappi F, Spadaccio C, Acar C. Use of allogeneic tissue to treat infective valvular disease: Has everything been said? J Thorac Cardiovasc Surg. 2017 Apr;153(4):824-828. doi: 10.1016/j.jtcvs.2016.09.071. Epub 2016 Oct 24. No abstract available. — View Citation

Nappi F, Spadaccio C, Dreyfus J, Attias D, Acar C, Bando K. Mitral endocarditis: A new management framework. J Thorac Cardiovasc Surg. 2018 Oct;156(4):1486-1495.e4. doi: 10.1016/j.jtcvs.2018.03.159. Epub 2018 Apr 13. No abstract available. — View Citation

Olivito S, Lalande S, Nappi F, Hammoudi N, D'Alessandro C, Fouret P, Acar C. Structural deterioration of the cryopreserved mitral homograft valve. J Thorac Cardiovasc Surg. 2012 Aug;144(2):313-20, 320.e1. doi: 10.1016/j.jtcvs.2011.06.041. Epub 2011 Sep 8. — View Citation

Sabik JF, Lytle BW, Blackstone EH, Marullo AG, Pettersson GB, Cosgrove DM. Aortic root replacement with cryopreserved allograft for prosthetic valve endocarditis. Ann Thorac Surg. 2002 Sep;74(3):650-9; discussion 659. doi: 10.1016/s0003-4975(02)03779-7. — View Citation

Savage EB, Saha-Chaudhuri P, Asher CR, Brennan JM, Gammie JS. Outcomes and prosthesis choice for active aortic valve infective endocarditis: analysis of the Society of Thoracic Surgeons Adult Cardiac Surgery Database. Ann Thorac Surg. 2014 Sep;98(3):806-1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment failure	The primary end point of the study is the degree of treatment failure as assessed by death, recurrent aortic valve regurgitation and reoperation	10 years
Secondary	Overall Mortality	The secondary endpoint of the study is the evaluation of overall mortality	10 years
Secondary	Cardiac Death	The secondary endpoint of the study is the evaluation of cardiac death	10 years
Secondary	Non Cardiac Death	The secondary endpoint of the study is the evaluation of non cardiac death	10 years
Secondary	Hospitalizations for Heart Failure (HF)	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	10 years
Secondary	Major Adverse Cardiac or Cerebrovascular Events (MACCE)	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.	10 years
Secondary	Echocardiographic Parameter Changes (LVEF)	Changes from baseline parameters including left ventricular ejection fraction	10 years
Secondary	Echocardiographic Parameter Changes (recurrence)	Recurrent moderate-to-severe aortic regurgitation after intervention	10 years
Secondary	Echocardiographic Parameter Changes (LVEDD)	Changes from baseline Left Ventricular End Diastolic Diameter	10 years
Secondary	Echocardiographic Parameter Changes (Aortic Root diameter)	Changes from baseline aortic root diameter	10 years