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Outcomes of Surgical Treatment in Patients With Infective Endocarditis

Outcomes of Surgical Treatment in Patients With Infective Endocarditis: a Retrospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07529730
Acronym
ETCEI
Enrollment
140
Registered
2026-04-14
Start date
2025-04-16
Completion date
2025-12-31
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infective Endocarditis (IE)

Brief summary

Infective endocarditis (IE) is a severe disease associated with significant morbidity and mortality despite advances in antimicrobial therapy and cardiac surgery. In complicated cases, surgical intervention is frequently required. This retrospective observational study aims to evaluate outcomes in adult patients undergoing cardiac surgery for infective endocarditis at the Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo of Alessandria. The primary objective is to assess 30-day mortality after surgery and to analyze clinical and surgical factors associated with adverse outcomes. Secondary objectives include the description of epidemiological, clinical, microbiological, and therapeutic characteristics of surgically treated infective endocarditis, the identification of predictors of postoperative complications, and the evaluation of mortality and recurrence of infection at 6 and 12 months after surgery. The study also assesses the consistency between documented surgical indications and the recommendations of the European Society of Cardiology (ESC) guidelines for the management of infective endocarditis.

Detailed description

Infective endocarditis (IE) remains a severe disease associated with high morbidity and mortality despite advances in antimicrobial therapy and cardiac surgery. Surgical treatment is often required in complicated cases, such as severe valvular dysfunction, uncontrolled infection, or high embolic risk. IE is characterized by the formation of vegetations, defined as pathological masses composed of fibrin, platelets, white blood cells, and microorganisms. These lesions mainly involve native or prosthetic cardiac valves but may occasionally develop on other endocardial devices.The microorganisms most frequently responsible for complicated forms of infective endocarditis are typically aggressive pathogens or organisms with resistance to antimicrobial therapy. In recent years, the incidence of infective endocarditis appears to show a continuous increasing trend. This increase may be related to several factors, including the aging of the population, the growing use of implantable cardiac devices, and changes in antibiotic prophylaxis strategies. These epidemiological changes highlight the need for continuous evaluation and improvement of diagnostic and therapeutic strategies for a disease that remains associated with substantial morbidity and mortality. This retrospective observational study includes all adult patients who underwent cardiac surgery for infective endocarditis between 2019 and 2024 at the University Hospital of Alessandria. The diagnosis of infective endocarditis is defined according to the modified Duke criteria and is retrospectively confirmed based on the available clinical documentation. The study also evaluates the consistency between documented surgical indications and the recommendations of the current European Society of Cardiology (ESC) guidelines for the management of infective endocarditis.

Interventions

OTHERData collection

Patients retrospectively enrolled who underwent surgery for infective endocarditis between 2019 and 2024. Data are collected in a dedicated electronic database.

Sponsors

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 * Patients admitted to the AOU AL and undergoing surgery between 2019 and 2024 for infectious endocarditis with ICD-9 diagnosis: O 4210 -Acute and subacute bacterial endocarditis O 4211-Acute and subacute infectious endocarditis in diseases Classified elsewhere O 4219 -Unspecified acute endocarditis O 42490 -Endocarditis, unspecified valve, specify Specified O 42491 -Endocarditis in diseases classified elsewhere O 42499 -Other endocarditis, valves not specified \- Signature of informed consent

Exclusion criteria

* Incomplete medical records or records with data missing that is relevant to this study * Severely immunocompromised patients (e.g. organ transplant patients, patients undergoing intensive chemotherapy, patients with advanced AIDS, etc.)

Design outcomes

Primary

MeasureTime frameDescription
30-day mortality after cardiac surgery for infective endocarditisUntil the completion of the study, which is expected to last approximately 12 months.Evaluation of mortality occurring within 30 days after cardiac surgery for infective endocarditis.

Secondary

MeasureTime frameDescription
Patient characteristics in complicated infective endocarditisUntil the completion of the study, which is expected to last approximately 12 months.Describe the characteristics of patients undergoing cardiac surgery for complicated infective endocarditis.
Predictors of postoperative complicationsUntil the completion of the study, which is expected to last approximately 12 months.Identification of possible predictors of post-operative complications (infections, thromboembolic events, organ failure, need for reoperation) in patients undergoing cardiac surgery for infective endocarditis.
Consistency of surgical indications with ESC guideline recommendationsUntil the completion of the study, which is expected to last approximately 12 months.Assessment of the concordance between the surgical indications documented for patients with complicated infective endocarditis and the recommendations of the 2023 European Society of Cardiology (ESC) guidelines.
Assessment of microorganismsUntil the completion of the study, which is expected to last approximately 12 months.Assessment of microorganisms based on antibiogram in relation to an increased probability of post-operative complications.
All-cause mortality at 6 months6 months post-surgery.All-cause mortality within 6 months after cardiac surgery for complicated infective endocarditis.
All-cause mortality at 12 months12 months post-surgery.All-cause mortality within 12 months after cardiac surgery for complicated infective endocarditis.
Infectious recurrence at 6 months6 months post-surgery.Recurrence of infective endocarditis or related infection within 6 months after surgery.
Infectious recurrence at 12 months12 months post-surgery.Recurrence of infective endocarditis or related infection within 12 months after surgery.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 15, 2026