Outcomes of Surgical Treatment in Patients With Infective Endocarditis (ETCEI)

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

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.

Study Overview

• Status: Completed
• Conditions: Infective Endocarditis (IE)
• Intervention / Treatment: Other: Data collection

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.

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• Italy
  • AL
    • Alessandria, AL, Italy, 15121
      • SC Cardiac Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who underwent surgery for infective endocarditis between 2019 and 2024

Description

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.)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Infective endocarditis (IE); Patients who have undergone surgery for infective endocarditis	Other: Data collection; Patients retrospectively enrolled who underwent surgery for infective endocarditis between 2019 and 2024. Data are collected in a dedicated electronic database.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day mortality after cardiac surgery for infective endocarditis	Evaluation of mortality occurring within 30 days after cardiac surgery for infective endocarditis.	Until the completion of the study, which is expected to last approximately 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient characteristics in complicated infective endocarditis	Describe the characteristics of patients undergoing cardiac surgery for complicated infective endocarditis.	Until the completion of the study, which is expected to last approximately 12 months.
Predictors of postoperative complications	Identification of possible predictors of post-operative complications (infections, thromboembolic events, organ failure, need for reoperation) in patients undergoing cardiac surgery for infective endocarditis.	Until the completion of the study, which is expected to last approximately 12 months.
Consistency of surgical indications with ESC guideline recommendations	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.	Until the completion of the study, which is expected to last approximately 12 months.
Assessment of microorganisms	Assessment of microorganisms based on antibiogram in relation to an increased probability of post-operative complications.	Until the completion of the study, which is expected to last approximately 12 months.
All-cause mortality at 6 months	All-cause mortality within 6 months after cardiac surgery for complicated infective endocarditis.	6 months post-surgery.
All-cause mortality at 12 months	All-cause mortality within 12 months after cardiac surgery for complicated infective endocarditis.	12 months post-surgery.
Infectious recurrence at 6 months	Recurrence of infective endocarditis or related infection within 6 months after surgery.	6 months post-surgery.
Infectious recurrence at 12 months	Recurrence of infective endocarditis or related infection within 12 months after surgery.	12 months post-surgery.

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2025
• Primary Completion (Actual): October 23, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Endocarditis; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Data Collection
• Other Study ID Numbers: ASO.Cch.25.02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No