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.
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.
Study Type
OBSERVATIONAL
Enrollment
900
There is no study-specific intervention. The investigators will record data generated by clinical activity before, during and after implementation of the PMI-screening. Follow-up data and the final PMI event adjudication will be the only data generated specifically for this study.
University Hospital Innsbruck
Innsbruck, Tyrol, Austria
RECRUITINGUniversity Hospital Geneva
Geneva, Canton of Geneva, Switzerland
NOT_YET_RECRUITINGCantonal Hospital Lucerne
Lucerne, Canton of Lucerne, Switzerland
RECRUITINGCanton Hospital Olten
Olten, Canton of Solothurn, Switzerland
ACTIVE_NOT_RECRUITINGBürgerspital Solothurn
Solothurn, Switzerland
RECRUITINGPerioperative Myocardial Infarction/Injury (PMI)-Screening (Reach)
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)
Time frame: during the hospital stay (up to postoperative day 2)
Incidence of PMI
Percentage of patients experiencing PMI following noncardiac surgery
Time frame: after the surgery until postoperative day 2
Cardiology consultation (Fidelity)
Percentage of patients with detected PMI by PMI-screening on screening days, seen vs. not seen by a cardiologist
Time frame: during hospital stay (up to postoperative day 5)
Diagnostic challenge
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
Time frame: during hospital stay (up to postoperative day 5)
Barriers to 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
Time frame: following the post-implementation period (6 months after implementation)
Medicoeconomic impact
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
Time frame: Within 3 - 30 days following surgery
Resource Usage
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
Time frame: Within 3 - 30 days following surgery
Major adverse cardiac events (MACE)
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
Time frame: 1 year
Complications of cardiology diagnostics
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)
Time frame: 30 days
Major bleeding
Bleeding Academic Research Consortium Typ 3-5
Time frame: Postoperative day 1 - 1 year (blinding of first 24h following surgery)
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