Magnetic resonance imaging for cerebral lesions during minimal invasive mitral valve surgery: study protocol for a randomized controlled trial.

BACKGROUND: Recent data have highlighted a higher rate of neurological injuries in minimal invasive mitral valve surgery (MIMVS) compared with the standard sternotomy approach; therefore, the role of specific clamping techniques and perfusion strategies on the occurrence of this complication is a matter of discussion in the medical literature. The purpose of this trial is to prospectively evaluate major, minor and silent neurological events in patients undergoing right mini-thoracotomy mitral valve surgery using retrograde perfusion and an endoaortic clamp or a transthoracic clamp. METHODS/DESIGN: A prospective, blinded, randomized controlled study on the rate of neurological embolizations during MIMVS started at the University of Turin in June 2014. Major, minor and silent neurological events are being investigated through standard neurological evaluation and magnetic resonance imaging assessment. The magnetic resonance imaging protocol includes conventional sequences for the morphological and quantitative assessment and nonconventional sequences for the white matter microstructural evaluation. Imaging studies are performed before surgery as baseline assessment and on the third postoperative day and, in patients who develop postoperative ischemic lesions, after 6 months. DISCUSSION: Despite recent concerns raised about the endoaortic setting with retrograde perfusion, we expect to show equivalence in terms of neurological events of this technique compared with the transthoracic clamp in a selected cohort of patients. With the first results expected in December 2016 the findings would be of help in confirming the efficacy and safety of MIMVS. TRIAL REGISTRATION: ClinicalTrials.gov, Identifier: NCT02818166 . Registered on 8 February 2016 - trial retrospectively registered.

Safety and usefulness of composite grafts for total arterial myocardial revascularization: a prospective randomized evaluation.

OBJECTIVES: To evaluate the results of total arterial revascularization with composite grafts compared with the results of conventional coronary surgery, we enrolled 200 consecutive patient undergoing myocardial revascularization. METHODS: Patients were randomly assigned to 2 groups of 100 patients each: group 1 underwent total arterial revascularization, and group 2 received left internal thoracic artery on left anterior descending artery grafts plus additional saphenous vein grafts. The groups were comparable in terms of continuous and discrete variables and preoperative risk factors. RESULTS: There were no differences between group 1 and group 2 in terms of the number of grafted vessels (mean, 2.8 vs 2.9, respectively), crossclamping time (mean, 38 +/- 7 vs 40 +/- 6 min, respectively), intensive care unit stay (mean, 25 +/- 8 vs 24 +/- 7 hours, respectively), and hospital mortality (1% in both groups) nor were there any differences in postoperative complications. At the mean follow-up of 12 +/- 4 months, patients receiving total arterial revascularization (group 1) showed a better outcome in terms of angina recurrence (group 1 vs group 2: 2 vs 13 patients, P =.007), need of percutaneous transluminal coronary angioplasty reintervention (group 1 vs group 2: 0 vs 8 patients, P =.0012), and actuarial freedom from cardiac events (group 1 vs group 2: 96% vs 67%, P =.006). Angiography carried out in 72% in group 1 and in 68% in group 2 demonstrated a patency rate of 99% of saphenous vein grafts in group 1 and 89% of saphenous grafts in group 2. CONCLUSIONS: Total myocardial revascularization with composite arterial grafts provided superior clinical results and improved patient outcome, even in the short term to midterm. Arterial conduit-related benefits were clearly evident with respect to recurrence of angina and a higher graft patency rate.