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NCT Number: NCT05253469

Infective Endocarditis Surgery Using Conventional Prosthetic Valves Versus Cryopreserved Aortic Homograft

: 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)

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Key information

Conditions

Infective Endocarditis Cardiovascular Diseases Endocarditis Heart Diseases Heart Failure

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Francesco Nappi

Saint-Denis, 93200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cryopreserved Aortic Homograft

Procedure

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

Other names: Root replacement, Commando procedure, Emicommando procedure

Stented/Non stented xenograft

Procedure

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

Other names: Root replacement, Commando procedure, Emicommando procedure

Mechanical prostheses

Procedure

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

Other names: Root replacement, Commando procedure

Primary outcomes

  1. Treatment failure

    Time frame: 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 outcomes

  1. Overall Mortality

    Time frame: 10 years

    The secondary endpoint of the study is the evaluation of overall mortality

  2. Cardiac Death

    Time frame: 10 years

    The secondary endpoint of the study is the evaluation of cardiac death

  3. Non Cardiac Death

    Time frame: 10 years

    The secondary endpoint of the study is the evaluation of non cardiac death

  4. Hospitalizations for Heart Failure (HF)

    Time frame: 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

  5. Major Adverse Cardiac or Cerebrovascular Events (MACCE)

    Time frame: 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.

  6. Echocardiographic Parameter Changes (LVEF)

    Time frame: 10 years

    Changes from baseline parameters including left ventricular ejection fraction

  7. Echocardiographic Parameter Changes (recurrence)

    Time frame: 10 years

    Recurrent moderate-to-severe aortic regurgitation after intervention

  8. Echocardiographic Parameter Changes (LVEDD)

    Time frame: 10 years

    Changes from baseline Left Ventricular End Diastolic Diameter

  9. Echocardiographic Parameter Changes (Aortic Root diameter)

    Time frame: 10 years

    Changes from baseline aortic root diameter

Sponsors and collaborators

Lead sponsor

Centre Cardiologique du Nord

Other

Collaborators

  • Aberdeen Royal Infirmary
  • Campus Bio-Medico University
  • Henri Mondor University Hospital
  • Universita degli Studi di Genova
  • University of Bristol

Registry information

Official study title

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

Acronym: IESCOPHO

Important dates

Study start
2005
Primary completion
2024
Study completion
2026
First posted
Feb 23, 2022
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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