Endoscopic Saphenous harvesting with an Open CO2 System (ESOS) trial for coronary artery bypass grafting surgery: study protocol for a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>In coronary artery bypass grafting surgery, arterial conduits are preferred because of more favourable long-term patency and outcome. Anyway <it>the greater saphenous vein </it>continues to be the most commonly used bypass conduit. <it>Minimally invasive endoscopic saphenous vein harvesting </it>is increasingly being investigated in order to reduce the morbidity associated with conventional open vein harvesting, includes postoperative leg wound complications, pain and patient satisfaction. However, to date the short and the long-term benefits of the endoscopic technique remain controversial. This study provides an interesting opportunity to address this gap in the literature.</p> <p>Methods/Design</p> <p><b>Endoscopic Saphenous harvesting with an Open CO₂System </b>trial includes two parallel vein harvesting arms in coronary artery bypass grafting surgery. It is an interventional, single centre, prospective, randomized, safety/efficacy, cost/effectiveness study, in adult patients with elective planned and first isolated coronary artery disease. A simple size of 100 patients for each arm will be required to achieve 80% statistical power, with a significant level of 0.05, for detecting most of the formulated hypotheses. A six-weeks leg wound complications rate was assumed to be 20% in the conventional arm and less of 4% in the endoscopic arm. Previously quoted studies suggest a first-year vein-graft failure rate of about 20% with an annual occlusion rate of 1% to 2% in the first six years, with practically no difference between the endoscopic and conventional approaches. Similarly, the results on event-free survival rates for the two arms have barely a 2-3% gap. Assuming a 10% drop-out rate and a 5% cross-over rate, the goal is to enrol 230 patients from a single Italian cardiac surgery centre.</p> <p>Discussion</p> <p>The goal of this prospective randomized trial is to compare and to test improvement in wound healing, quality of life, safety/efficacy, cost-effectiveness, short and long-term outcomes and vein-graft patency after endoscopic open CO₂harvesting system versus conventional vein harvesting.</p> <p>The expected results are of high clinical relevance and will show the safety/efficacy or non-inferiority of one treatment approach in terms of vein harvesting for coronary artery bypass grafting surgery.</p> <p>Trial registration</p> <p>www.clinicalTrials.gov <a href="http://www.clinicaltrials.gov/ct2/show/NCT01121341">NCT01121341</a>.</p

Effect of total arterial grafting in the Arterial Revascularization Trial

Objectives The Arterial Revascularization Trial (ART) was designed to compare 10-year survival in bilateral versus single internal thoracic artery grafts. The intention-to-treat analysis has showed comparable outcomes between the 2 groups but an explanatory analysis suggested that those receiving 2 or more arterial grafts had better survival. Whether the exclusive use of arterial grafts provide further benefit is unclear. Methods We performed an exploratory analysis of the ART based on conduits actually received (as-treated principle). From ART cohort, only patients receiving at least 3 grafts were included. The final population consisted of 1084, 1010, and 390 patients in the single arterial graft (SAG) group, in the multiple arterial graft (MAG) group (2 or more arterial grafts with additional saphenous veins) and total arterial graft (TAG) group (3 or more arterial grafts only) respectively. Inverse probability of treatment weighting was used for comparison. Results When compared with the SAG group, there was a significant trend toward a reduction of 10-year mortality in the MAG and TAG group (test for trend P = .02). The TAG group was associated with the lowest risk of late mortality (hazard ratio, 0.68; 95% confidence interval, 0.48-0.96; P = .03) and with a significant risk reduction of the composite of death/myocardial infarction/stroke and repeat revascularization (hazard ratio, 0.71; 95% confidence interval, 0.53-0.94; P = .02). Conclusions When compared with SAG, both MAG and TAG represent valuable strategies to improve clinical outcomes following coronary artery bypass grafting but TAG can potentially provide further benefit.</p

Initial experience with off-pump left ventricular assist device implantation in single center: retrospective analysis

<p>Abstract</p> <p>Background</p> <p>We hypothesize that implantation of left ventricular assist device through off-pump technique is feasible and has a comparable result to implantation on cardiopulmonary bypass and could improve one-year survival.</p> <p>Methods</p> <p>This retrospective, observational, single-center study was conducted on 29 consecutive patients at our institution who underwent off-pump left ventricular assist device implantation by a single surgeon.</p> <p>Results</p> <p>Twenty-seven procedures were performed successfully using the off-pump technique. The survival rate was 92% at 30 days, 76% at 90 days, and 67% at one year. We compared the one-year survival of different implantation periods, and divided our study into three time intervals (2004-2005, 2006, and 2007). There was a trend in reduction in number of deaths over one year that demonstrated a decrease in death rate from 50% to 17%, as well as improvement in our experience over time. However, this trend is not statistically significant (p = 0.08) due to limited sample size.</p> <p>Conclusions</p> <p>Based upon our findings, off-pump left ventricular assist device implantation is a feasible surgical technique, and combining this technique with improved device technology in the future may provide even greater improvement in patient outcomes.</p

Angiographic outcome of coronary artery bypass grafts: Radial Artery Database International Alliance

BACKGROUND: We used a large patient-level dataset including six angiographic randomized trials (RCTs) on coronary artery bypass conduits to explore incidence and determinants of coronary graft failure. METHODS: Patient-level angiographic data of six RCTs comparing long-term outcomes of the radial artery and other conduits were joined. Primary outcome was graft occlusion at maximum follow-up. The analysis was divided as follows: 1) left anterior descending coronary (LAD) distribution, 2) non-LAD distribution (circumflex and right coronary artery). To identify predictors of graft occlusion, mixed model multivariable Cox regression including all baseline characteristics with stratification by individual trials was used. RESULTS: 1091 patients and 2281 grafts were included (921 left internal mammary arteries, 74 right internal mammary arteries, 710 radial artery and 576 saphenous veins; all left internal mammary arteries were used on the LAD, the other conduits were used on the non-LAD distribution; mean angiographic follow up: 65±29 months). Occlusion rate was 2.3%, 13.5%, 9.4%, 17.5% for the left internal mammary arteries, right internal mammary arteries, radial artery and saphenous veins, respectively. At multivariable analysis type of conduit used, age, female gender, left ventricular ejection fraction<50% and use of the Y graft were significantly associated with graft occlusion in the non-LAD distribution. CONCLUSIONS: Our analyses showed that failure of the left internal mammary arteries to LAD bypass is a very uncommon event. For the non-LAD distribution, the non-use of radial artery, age, female gender, left ventricular ejection fraction<50% and use of the Y graft configuration were significantly associated with mid-term graft failure

The impact of avoiding cardiopulmonary by-pass during coronary artery bypass surgery in elderly patients: the Danish On-pump Off-pump Randomisation Study (DOORS)

<p>Abstract</p> <p>Background</p> <p>Coronary Artery Bypass Graft operation for ischemic heart disease provides improved quality of life and, in some patients, prolonged survival. Concern has, however, been raised about complications that may be related to the use of cardiopulmonary by-pass (CPB) and aortic cross-clamping. It has been hypothesized that when coronary artery by-pass grafting is performed without the use of CPB, the rate of serious complications is reduced.</p> <p>Methods/Design</p> <p>The trial is designed as an open, randomized, controlled, clinical trial with blinded assessment of end-points. Patients at or above 70 years of age, referred for surgical myocardial revascularisation, are included and randomised to receive coronary artery by-pass grafting either with or without the use of CPB and aortic cross-clamping. Follow-up is performed by clinical, biochemical, electrocardiographic, and angiographic data that are evaluated by independent committees that are blinded with respect to the result of the randomisation. End points include mortality, stroke, myocardial infarction, graft patency, quality of life, and cost-effectiveness. The trial is performed in four different Danish, cardiac surgery centres.</p> <p>Trial registration</p> <p>ClinicalTrials.gov NCT00123981</p

Evaluation of preoperative intra-aortic balloon pump in coronary patients with severe left ventricular dysfunction undergoing OPCAB surgery: early and mid-term outcomes

<p>Abstract</p> <p>Background</p> <p>The purpose of the present study was to evaluate the safety and the cost-effectiveness of using preoperative IABP as support compared with postoperative IABP treatment in coronary patients with severe left ventricular dysfunction (SLVD) who is undergoing off-pump coronary artery bypass surgery (OPCAB), including early outcomes, hospital mortality and morbidity, and mid-term follow-up outcomes.</p> <p>Methods</p> <p>Between March 2000 and December 2008, we prospectively and randomly studied the insertion of preoperative IABP in 115 (7.4%) and postoperative IABP in 106 (6.8%) of the 1560 consecutive patients. Group A is preoperative IABP therapy. Group B is postoperative IABP therapy.</p> <p>Results</p> <p>There was no significant difference in the number of grafts used between the two groups. Completeness of revascularization did not differ between the two groups. The statistically significant difference was hospital mortality (2.6% in group A vs. 3.8% in group B) (<it>p </it>< 0.05). And there was significant reduction in postoperative low cardiac output, malignant arrhythmia, acute renal failure and length of stay in ICU in group A, compared with group B (<it>p </it>< 0.05). In the two groups, six-, 12-, 24- and 48-month survival rates were similar. In the study the degree of improvement in angina and quality of life did not differ significantly between the two groups.</p> <p>Conclusion</p> <p>The use of preoperative IABP in SLVD patients undergoing OPCAB is of safety and effectiveness. The combined use of preoperative IABP and OPCAB allows complete revascularization in SLVD patients with an important reduction in operative mortality and excellent mid-term results.</p