MD; for the COPPS-2 Investigators IMPORTANCE Postpericardiotomy syndrome, postoperative atrial fibrillation (AF), and postop-erative effusions may be responsible for increased morbidity and health care costs after cardiac surgery. Postoperative use of colchicine prevented these complications in a single trial. OBJECTIVE To determine the efficacy and safety of perioperative use of oral colchicine in reducing postpericardiotomy syndrome, postoperative AF, and postoperative pericardial or pleural effusions. DESIGN, SETTING, AND PARTICIPANTS Investigator-initiated, double-blind, placebo-controlled, randomized clinical trial among 360 consecutive candidates for cardiac surgery enrolled in 11 Italian centers between March 2012 and March 2014. At enrollment, mean age of the trial participants was 67.5 years (SD, 10.6 years), 69% were men, and 36% had planned valvular surgery. Main exclusion criteria were absence of sinus rhythm at enrollment, cardiac transplantation, and contraindications to colchicine. INTERVENTIONS Patients were randomized to receive placebo (n=180) or colchicine (0.5 mg twice daily in patients 70 kg or 0.5 mg once daily in patients <70 kg; n=180) starting between 48 and 72 hours before surgery and continued for 1 month after surgery. MAIN OUTCOMES AND MEASURES Occurrence of postpericardiotomy syndrome within 3 months; main secondary study end points were postoperative AF and pericardial or pleural effusion. RESULTS The primary end point of postpericardiotomy syndrome occurred in 35 patients (19.4%) assigned to colchicine and in 53 (29.4%) assigned to placebo (absolute difference, 10.0%; 95% CI, 1.1%-18.7%; number needed to treat = 10). There were no significant differences between the colchicine and placebo groups for the secondary end points of postoperative AF (colchicine, 61 patients [33.9%]; placebo, 75 patients [41.7%]; absolute difference, 7.8%; 95% CI, −2.2% to 17.6%) or postoperative pericardial/pleural effusion (colchicine, 103 patients [57.2%]; placebo, 106 patients [58.9%]; absolute difference, 1.7%; 95% CI, −8.5% to 11.7%), although there was a reduction in postoperative AF in the prespecified on-treatment analysis (placebo, 61/148 patients [41.2%]; colchicine, 38/141 patients [27.0%]; absolute difference, 14.2%; 95% CI, 3.3%-24.7%). Adverse events occurred in 21 patients (11.7%) in the placebo group vs 36 (20.0%) in the colchicine group (absolute difference, 8.3%; 95% CI; 0.76%-15.9%; number needed to harm = 12), but discontinuation rates were similar. No serious adverse events were observed. CONCLUSIONS AND RELEVANCE Among patients undergoing cardiac surgery, perioperative use of colchicine compared with placebo reduced the incidence of postpericardiotomy syndrome but not of postoperative AF or postoperative pericardial/pleural effusion. The increased risk of gastro-intestinal adverse effects reduced the potential benefits of colchicine in this setting.

We report the reliability and safety of percutaneous liver biopsy in the evaluation of hepatic iron loading and histology in patients with homozygous /3thalassaemia prior to and in serial biopsies following allogeneic bone marrow transplantation for this disorder. 501 thalassaemic patients aged 11 + 4.5 years (range 1-32

Objective Video-assisted minimally invasive mitral valve surgery can be performed through different approaches. The aim of the study was to report our early results and compare the external transthoracic aortic clamping with the endoaortic balloon occlusion techniques according to our experience. Methods Between January 2000 and March 2010, 138 patients (103 women, aged 58.4 ± 10.2 years) underwent video-assisted mitral valve surgery through a right thoracotomy. Cardiopulmonary bypass was instituted by femoral arterial and bicaval cannulation with active venous drainage and normothermia; cardioplegic arrest achieved with intermittent blood cardioplegia. In group A (93 patients, 68 women, aged 58.8 ± 7.8 years, 72 MV replacement, 21 MV repair), aortic clamping was achieved using the external transthoracic aortic clamp. In group B (45 patients, 35 women, aged 58.1 ± 11.4 years, 33 MV replacement, 12 MV repair), aortic clamping was achieved with endoaortic balloon occlusion. Results Intraoperative procedure-associated problems were experienced in one patient (0.7%) in group A (one conversion to sternotomy for pleural adhesions and bad exposure). At a mean follow-up of 36 ± 18 months, 135 patients (97.8%) were in New York Heart Association class I to II, with satisfactory echocardiographic follow-up. In group A, two patients had noncardiac-related deaths. No perioperative deaths were observed in both groups. There were four (2.8%) transient ischemic attacks and one (0.7%) peripheral ischemic event (group A) during the early postoperative period. Mitral valve repair patients had a 5-year freedom from reoperation of 100% in both groups. There was no significant difference between the two groups regarding preoperative variables, such as age, sex, New York Heart Association class, and left ventricular ejection fraction (P ≥ 0.05). Postoperative levels of myocardial cytonecrosis enzymes (MB fraction, creatine kinase, and troponine I) as well as operative time, extracorporeal circulation, and aortic cross-clamping times or ventilation and intensive care unit times were not significantly different between the two groups (P ≥ 0.05). More microembolic events were observed in group A than in group B (total 143.4 ± 30.6 per patient vs 78.9 ± 28.6 per patient) by means of continuous automated intraoperative transcranial Doppler evaluations (P < 0.05) applied to part of population. Conclusions Both techniques proved safe and comparable with low risk of morbidity and mortality. Patients undergoing endoclamp technique resulted to be less subject to embolism.

Right ventricular failure after continuous-flow left ventricular assist device (LVAD) implantation is still an unsolved issue and remains a life-threatening event for patients. We undertook this study to determine predictors of the patients who are candidates for isolated LVAD therapy as opposed to biventricular support (BVAD). We reviewed demographic, echocardiographic, hemodynamic, and laboratory variables for 258 patients who underwent both isolated LVAD implantation and unplanned BVAD because of early right ventricular failure after LVAD insertion, between 2006 and 2017 (LVAD = 170 and BVAD = 88). The final study patients were randomly divided into derivation (79.8%, n = 206) and validation (20.1%, n = 52) cohorts. Fifty-seven preoperative risk factors were compared between patients who were successfully managed with an LVAD and those who required a BVAD. Nineteen variables demonstrated statistical significance on univariable analysis. Multivariable logistic regression analysis identified destination therapy (odds ratio [OR] 2.0 [1.7-3.9], p = 0.003), a pulmonary artery pulsatility index <2 (OR 3.3 [1.7-6.1], p = 0.001), a right ventricle/left ventricle end-diastolic diameter ratio >0.75 (OR 2.7 [1.5-5.5], p = 0.001), an right ventricle stroke work index <300 mm Hg/ml/m (OR 4.3 [2.5-7.3], p < 0.001), and a United Network for Organ Sharing modified Model for End-Stage Liver Disease Excluding INR score >17 (OR 3.5 [1.9-6.9], p < 0.001) as the major predictors of the need for BVAD. Using these data, we propose a simple risk calculator to determine the suitability of patients for isolated LVAD support in the era of continuous-flow mechanical circulatory support devices.

Long-term HeartMate II LVAD provides good mid-term, long-term results. This new technology requires delicate management. Functional status and quality of life greatly improve in patients who survive the perioperative period.