Effect of implantable cardioverter-defibrillator implantation on surgical morbidity in the CABG Patch Trial. Surgical Investigators of the Coronary Artery Bypass Graft Patch Trial.

BACKGROUND

The Coronary Artery Bypass Graft (CABG) Patch Trial tested the hypothesis that prophylactic insertion of an implantable cardioverter-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 undergo CABG (control subjects, n = 454) or CABG plus ICD implantation (n = 446). There were no significant differences between groups in the incidence of diabetes, ejection fraction < 0.25, end-diastolic pressure, prior 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 concerned that ICD therapy could increase surgical mortality rates or the incidence of shock, bleeding, congestive heart failure, arrhythmias, or deep sternal wound infection. Of these, only sternal wound infection 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 psychotic reaction (4% versus 1%). The all-cause death rate was 6.7% in the ICD group and 4.6% for control patients (P = NS) at the time of the last surgical death, postoperative day 48.

CONCLUSIONS

Epicardial ICD insertion during CABG is associated with an increase in perioperative infection. Although reporting bias may have influenced the data, if ICD insertion is indicated in CABG patients, metachronous endocardial implantation should be considered.