Funcional Recovery After Minithoracotomy or Sternotomy for CABG in Frail Patients

The Short Form-36 Health Survey, version 2 (SF-36v2), will be administered before surgery and 30 days after surgery. The primary outcome is the change in the Physical Component Summary score, calculated as the 30-day score minus the baseline score. SF-36 scores are transformed to a 0-to-100 scale, with higher scores indicating better self-reported physical health and functioning.

Percentage of participants experiencing at least one component of the composite outcome of perioperative myocardial infarction, angina, repeat coronary revascularization, or stroke. Each participant will be counted once in the composite, regardless of the number of events experienced.

Perioperative myocardial infarction will be defined according to the prespecified study criteria using postoperative high-sensitivity troponin levels and evidence of new myocardial ischemia. Stroke will be defined as a focal neurological deficit without complete spontaneous resolution within 24 hours.

Percentage of participants who die from any cause within 30 days after the index surgical procedure.

Percentage of participants experiencing perioperative myocardial infarction, defined as a postoperative high-sensitivity cardiac troponin concentration greater than 500 times the assay upper reference limit, or greater than 35 times the upper reference limit accompanied by evidence of new myocardial ischemia. Evidence of ischemia may include new ischemic electrocardiographic changes, documented coronary artery or graft occlusion, new loss of viable myocardium, or a new regional ventricular wall-motion abnormality.

Percentage of participants experiencing a new focal neurological deficit without complete spontaneous resolution within 24 hours after onset

Percentage of participants requiring repeat surgical or percutaneous coronary revascularization after the index procedure. This includes surgical revision or creation of coronary anastomoses and percutaneous coronary intervention performed after the index surgery.

Percentage of participants reporting postoperative angina. Angina is defined as retrosternal chest discomfort, with or without radiation, that worsens with exertion and/or improves with vasodilator therapy and is neither pleuritic nor reproducible by chest-wall palpation.

Time, measured in hours, from postoperative admission to the intensive care unit while receiving invasive mechanical ventilation until the first successful extubation.

Percentage of participants requiring invasive mechanical ventilation for more than 24 hours after admission to the intensive care unit.

Time, measured in hours, from postoperative admission to the intensive care unit until documentation that the participant meets the prespecified criteria for discharge from the intensive care unit.

Time, measured in hours, from hospital admission for the index surgical procedure until documentation that the participant meets the prespecified objective criteria for hospital discharge.

Number of days from the index surgery until the participant reports returning to the same or a better level of usual activities or functional status compared with the preoperative level.

Postoperative pain intensity measured using an 11-point Numeric Rating Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Pain scores will be assessed separately on postoperative days 1, 2, and 3.

Percentage of participants with a deep surgical site infection involving the primary thoracic surgical incision. Infection will be identified by compatible clinical findings, such as fever, purulent drainage, wound instability, or deep tissue involvement, and confirmed by imaging, microbiological testing, surgical findings.

Percentage of participants developing acute kidney injury, defined as an increase in serum creatinine of at least 0.3 mg/dL within 48 hours after surgery.

Percentage of participants requiring an additional surgical procedure to revise the index coronary revascularization, treat a complication caused by the index procedure, or re-enter the chest through the original or an alternative surgical access.

Percentage of participants assigned to minimally invasive coronary artery bypass grafting who require intraoperative conversion from left minithoracotomy to median sternotomy for completion of the operation or management of a complication.

Percentage of participants in whom all coronary targets included in the final preoperative revascularization plan are successfully treated during the index procedure, either surgically or as part of a planned hybrid revascularization strategy, as documented in the operative and procedural records.

Number of prespecified enhanced recovery measures successfully completed for each participant, ranging from 0 to 5. The measures are: abbreviated preoperative fasting, avoidance of preoperative sedatives or anxiolytics, opioid-sparing anesthesia, regional anesthesia before or after surgery, and extubation within 6 hours after intensive care unit admission. Higher scores indicate greater protocol adherence.

Percentage of participants successfully extubated within 6 hours after postoperative admission to the intensive care unit.

Percentage of participants readmitted to any hospital for any reason after discharge from the index hospitalization. Transfers to a supporting hospital solely for warfarin dose adjustment will not be classified as readmissions.

Percentage of participants with an index hospital stay of fewer than 6 days.

Percentage of participants with an index hospital stay of more than 14 days.