Implementation of a Clinical Screening and Response System for Cardiac Complications After Noncardiac Surgery
- Conditions
- Myocardial InjuryMyocardial InfarctionPerioperative Complication
- Interventions
- Other: Patient assessment and follow-up
- Registration Number
- NCT05859620
- Lead Sponsor
- University Hospital, Basel, Switzerland
- Brief Summary
The investigators aim to show the feasibility and medicoeconomic impact of implementing a clinical screening and response system for the early detection of perioperative cardiac complications in high-risk patients.
Specifically, the investigators aim to: 1) evaluate the feasibility of implementation of a PMI-screening; 2) evaluate the medicoeconomic impact of implementing a PMI-screening; 3) identify barriers to implementation; 4) generate data for a future randomized controlled trial on outcomes by exploring opportunities to improve care following PMI, the occurrence and timing of major adverse cardiac events (MACE), and the treatment effect associated with PMI-screening.
- Detailed Description
Background: Perioperative myocardial infarction/injury (PMI) is increasingly recognised as frequent, but often undiagnosed and untreated contributor to mortality following noncardiac surgery. Due to differences in pathophysiology and perioperative anaesthesia and analgesia, most PMI do not cause typical ischemic symptoms and are therefore missed in routine clinical practice. Active surveillance using cardiac troponin (cTn) is now guideline-recommended for the early detection of PMI to possibly improve outcome1. Given substantial concerns regarding the feasibility and health economic impact of implementing such a strategy, it is not yet widely applied.
Aim: to show feasibility of implementation as well as health economic impact of an active surveillance for the early detection of PMI in high-risk patients.
Methodology: in this observational before-after study the investigators will enrol patients at high cardiovascular risk undergoing noncardiac surgery before and after implementation of a PMI screening. Patients in the pre-implementation phase will receive standard of care, while in the post-implementation phase patients receive a PMI-screening, consisting of a preoperative and two postoperative measurements of high-sensitivity cTn (hs-cTn) and a cardiology consultation will be done in case of detection of a PMI. Patient data, resource utilisation, and PMI-aetiology will be collected. Interviews with key stakeholders will identify barriers to implementation. One-year follow-up will be conducted to evaluate occurrence of death, MACE, and safety endpoints.
Potential significance: This study will generate important insights regarding the feasibility, safety and the health economic impact of implementing an active surveillance for the early detection of PMI.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 900
- Consecutive patients fulfilling the institutional criteria for inclusion into the routine PMI-screening
- aged 40-85 years
- at increased cardiovascular risk
- undergoing inpatient, noncardiac, elective or emergent surgery
- postoperative stay of ≥2 nights at the participating institution
- orthopaedic, traumatology, vascular, spinal, thoracic, neurosurgical, and visceral surgery.
- patients with cardiac surgery or interventions in the last 14 days
- chronic renal failure under dialysis, renal transplant surgery
- moderate-to-severe dementia
- previous inclusion within 5 days
- documented refusal to use of their data for research purposes or refusal of further use during follow-up
- Patients declining consent for follow-up will be excluded from follow-up analyses.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description After implementation Patient assessment and follow-up Patients included after implementation of the PMI-screening Before implementation Patient assessment and follow-up Patients included before implementation of the PMI-screening
- Primary Outcome Measures
Name Time Method Diagnostic challenge during hospital stay (up to postoperative day 5) Number of cases with mismatch of initial classification of PMI aetiology (and management pathway) at time of consultation versus final adjudication. In case of two differential diagnoses stated on the cardiology consultation, mismatch is seen when none of the diagnoses correspond to the final adjudication. If three or more differential diagnoses are stated, mismatch is seen in any case even if the final adjudication diagnosis is stated
Incidence of PMI after the surgery until postoperative day 2 Percentage of patients experiencing PMI following noncardiac surgery
Cardiology consultation (Fidelity) during hospital stay (up to postoperative day 5) Percentage of patients with detected PMI by PMI-screening on screening days, seen vs. not seen by a cardiologist
Perioperative Myocardial Infarction/Injury (PMI)-Screening (Reach) during the hospital stay (up to postoperative day 2) Percentage of patients eligible for PMI-screening according to inclusion criteria, but not screened during the implementation phase (defined as no or only one measurement of hs-cTn done during screening days)
Barriers to implementation following the post-implementation period (6 months after implementation) Barriers to implementation will be assessed by a semi-quantitive questionnaire complemented by qualitative focus group including the local investigators and representatives of cardiology and anaesthesiology
- Secondary Outcome Measures
Name Time Method Resource Usage Within 3 - 30 days following surgery Number of postoperative blood draws on day 1 and 2, length of hospital stay, days on intensive care unit, consultations within day 1-3, ECG within day 1-3, cardiac stress testing within 30 days, and cardiac catheterisation within 30 days
Complications of cardiology diagnostics 30 days Number of inappropriate interventions or complications of cardiology diagnostics and interventions, consisting of: Overtreatment (Coronary angiographies showing normal coronaries), complications of cardiac interventions (myocardial infarction, stroke, death)
Medicoeconomic impact Within 3 - 30 days following surgery Cost of postoperative blood draws on day 1 and 2, length of hospital stay, days on intensive care unit, consultations within day 1-3, ECG within day 1-3, cardiac stress testing within 30 days, and cardiac catheterisation within 30 days, denoted in Swiss Francs
Major bleeding Postoperative day 1 - 1 year (blinding of first 24h following surgery) Bleeding Academic Research Consortium Typ 3-5
Major adverse cardiac events (MACE) 1 year Occurrence and timing of a composite of major adverse cardiac events (MACE) within twelve months, consisting of: All-cause death, acute myocardial infarction Type 1, survived sudden cardiac death, and Acute heart failure
Trial Locations
- Locations (5)
Bürgerspital Solothurn
🇨🇭Solothurn, Switzerland
Cantonal Hospital Lucerne
🇨🇭Lucerne, LU, Switzerland
Canton Hospital Olten
🇨🇭Olten, SO, Switzerland
University Hospital Innsbruck
🇦🇹Innsbruck, Tyrol, Austria
University Hospital Geneva
🇨🇭Geneva, GE, Switzerland