EFFECT OF IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR IMPLANTATION ON SURGICAL MORBIDITY IN THE CABG PATCH TRIAL

Background-The Coronary Artery Bypass Graft (CABG) Patch Trial tested the hypothesis that prophylactic insertion of an implantable cardiover ter-defibrillator (ICD) improves survival rates after high-risk CABG. We compared group-specific perioperative morbidity and mortality rates . Methods and Results-Patients were randomized intraoperatively to und ergo CABG (control subjects, n=454) or CABG plus ICD implantation (n=4 46). There were no significant differences between groups in the incid ence of diabetes, ejection fraction <0.25, end-diastolic pressure, pri or myocardial infarction, or congestive heart failure. Cardiopulmonary bypass time averaged 106 minutes in control subjects and 127 minutes in the ICD group. At the inception of the trial, investigators were co ncerned that ICD therapy could increase surgical mortality rates or th e incidence of shock, bleeding, congestive heart failure, arrhythmias, or deep sternal wound infection. Of these, only sternal wound infecti on was significantly more frequent in the ICD group (2.2% versus 0.4%, P<0.05). Also more common in the ICD group were infection at a wound or catheter site (12% versus 6%), urinary tract infection (4% versus 1 %), pneumonitis (8% versus 4%), respiratory insufficiency (13% versus 8%), transient central nervous system deficit (6% versus 2%), and psyc hotic reaction (4% versus 1%). The all-cause death rate was 6.7% in th e ICD group and 4.6% for control patients (P=NS) at the time of the la st surgical death, postoperative day 48. Conclusions-Epicardial ICD in sertion during CABG is associated with an increase in perioperative in fection. Although reporting bias may have influenced the data, if ICD insertion is indicated in CABG patients, metachronous endocardial impl antation should be considered.