On-pump versus off-pump coronary surgery outcomes in patients requiring dialysis: perspectives from a single center and the United States experience.

OBJECTIVE: Coronary artery bypass graft surgery carries increased risk for patients requiring dialysis compared with other groups. Little data exist comparing outcomes of on-pump and off-pump techniques in dialysis patients. This study compares outcomes of bypass grafting in dialysis patients with these two techniques at a single institution and in the United States Renal Data System (USRDS) database. METHODS: From March 1997 to April 2004, 37 patients requiring dialysis underwent bypass graft surgery at our institution. On-pump surgery was performed for 16 patients and off-pump surgery for 21. From January 1, 2001, to December 31, 2002, a total of 3922 patients in the USRDS underwent bypass graft surgery. On-pump surgery was performed for 3382 and off-pump surgery for 540. Comparisons were made between patients undergoing on-pump and off-pump bypass surgery with respect to demographics, risk factors, and outcomes. Univariate analysis, the Kaplan-Meier method, and a multivariate Cox model were used. RESULTS: Institutional analysis revealed similar patient demographics, risk factors, use of thoracic artery grafts, and number of distal anastomoses. Outcome analysis was significant for less postoperative atrial fibrillation with the off-pump technique: 37.5% on-pump and 4.8% off-pump (P = .028). USRDS data revealed all-cause survivals at 1 and 18 months of 87.5% and 59.5% for on-pump versus 88.3% and 61.9% for off-pump procedures (P = .226). In a comorbidity-adjusted Cox model, off-pump bypass grafting was associated with a 16% reduction in all-cause mortality (P = .032). CONCLUSION: Off-pump bypass grafting is uncommon in patients in the United States who require dialysis. Off- pump bypass grafting provides a morbidity benefit and is associated with a lower risk of death.

Long-term (2-year) clinical events following transthoracic intramyocardial gene transfer of VEGF-2 in no-option patients.

BACKGROUND: The short-term clinical impact of intramyocardial gene transfer (GT) of the angiogenic protein vascular endothelial growth factor-2 (VEGF-2) has been previously reported to significantly reduce Canadian Cardiovascular Society (CCS) angina class and to prolong exercise treadmill test (ETT) time. We describe the safety and long-term events (>1 year) in consecutive, nonrandomized, patients who received intramyocardial VEGF-2. METHODS: Thirty patients with intractable CCS class III or IV angina and no options for revascularization underwent direct intramyocardial GT of VEGF-2 naked DNA via limited thoracotomy at total doses of 0.2, 0.8, or 2.0 mg. Patients were followed for clinical events after 1 year by hospital records, follow-up visits or telephone contact. Due to one perioperative death, 29 patients were followed. RESULTS: At a mean follow-up of 751 +/- 102.5 days (range 459-959) there were four deaths (13.8%), five myocardial infarctions (MIs) (17.2%), and seven revascularization procedures (24.1%). There were 15 hospitalizations in 12 patients. At the end of the follow-up period no patient (0%) had CCS class IV angina, 3 patients (11.5%) had class III angina, and 23 (88.5%) had class I to II angina. There were two new diagnoses of cancer. CONCLUSION: Transthoracic intramyocardial injection of VEGF-2 is associated with an improvement of symptoms of angina in the majority of patients beyond the first year of treatment. Major clinical events such as death, MI, and repeat revascularization are uncommon during the first year but more frequent after 1 year at a rate consistent with the severity of underlying disease in this population with advanced atherosclerosis. The majority of events were the result of progression of disease in areas of the heart remote from the site of GT. A large randomized trial is planned to determine the efficacy of intramyocardial VEGF-2 injections in inoperable patients.

One-year follow-up of direct myocardial gene transfer of vascular endothelial growth factor-2 using naked plasmid deoxyribonucleic acid by way of thoracotomy in no-option patients.

This phase I open label, dose-escalating study shows that gene transfer of vascular endothelial growth factor-2 naked deoxyribonucleic acid by direct myocardial injection by way of thoracotomy in patients with Canadian Cardiovascular Society class 3 or 4 angina is feasible and safe. The procedure is well tolerated, with few major adverse cardiac events at 1 year, and without complications directly related to gene expression. In this prospective, nonblinded study, the procedure is associated with clinical improvement; however, there was no angiographic evidence of angiogenesis and there is a great potential for a sham or placebo effect in the study patients. A randomized phase III trial is underway that will help determine the efficacy of vascular endothelial growth factor-2 gene transfer in "no-option" patients.