Colchicine for prevention of postpericardiotomy syndrome and postoperative atrial fibrillation: the COPPS-2 randomized clinical trial.

IMPORTANCE: Postpericardiotomy syndrome, postoperative atrial fibrillation (AF), and postoperative 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 gastrointestinal adverse effects reduced the potential benefits of colchicine in this setting. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01552187.

Diffuse coronary disease: short- and long-term outcome after percutaneous coronary intervention.

AIM: The aim of this study was to evaluate short- and long-term results of PCI (percutaneous coronary intervention) in patients with small vessel coronary artery disease and the prognostic impact of the extension and the length of coronary lesions. METHODS AND RESULTS: All consecutive patients treated with PCI in our centre between July 2002 and December 2004 were included and divided into two groups according to the diameter of the implanted stents: small vessel disease was defined as requiring implantation of stents < 2.75 mm in diameter. The primary end point was the long-term incidence of major adverse cardiac events (MACE), the composite of cardiac mortality, nonfatal myocardial reinfarction, and repeated percutaneous target vessel revascularization (re-PTCA TVR). 1599 patients were treated by PCI: 419 (26.2%) were implanted with 2.75 mm or smaller stents. At both 1 and 36 months as well as at 53 + 20 months of follow-up small vessel stenting was associated with a higher rate of MACE (4.2% vs 2.1%, P= 0.028; 20.3% vs 17.9%, P <0.001; 27.5% vs 22.4%, P= 0.04, respectively). Multivariate analysis showed higher rates of revascularization for patients with small vessel disease regardless of lesion length. Rates of death were higher in patients with small vessels and long lesions. CONCLUSION: Atherosclerotic involvement of small vessels in patients with CAD confers a higher short- and long-term risk of adverse outcome after PCI.

Timing, positioning and ancillary therapies: the triad for successful Impella RP.

Clear clinical guidelines for the assessment and treatment of right ventricular failure (RVF) remain an unmet need. Although high complexity patients are common in this setting, the ideal management remains uncertain, resulting in high mortality rates despite presumably optimal medical therapy. Timely treatment with Impella RP may offer benefits by supplying circulatory support during the acute RVF phase and providing the time and unloading necessary for native right heart recovery. As such, mastering the technicalities and ancillary therapies is crucial to best utilize this salvage opportunity, particularly in these high complexity patients. Here, we report three different clinical scenarios of medically refractory RVF supported with Impella RP to provide examples and discuss the contribution of mechanical RV support to patient outcomes.

Impella 5.0/5.5 Implantation via Innominate Artery: Further Expanding the Opportunities for Temporary Mechanical Circulatory Support.

When axillary/subclavian arteries are not suitable because of size or anatomy, alternative access for the Impella pump 5.0/5.5 via the innominate artery allows circulatory support and eventually de-escalation from VA-ECMO to isolated left-side support. Moreover, less invasive surgery without the need to open the pericardium reduces the risk of RV dysfunction and bleeding. Finally, upper body strategies allow early rehabilitation during support, which is associated with improved survival in cardiogenic shock.

Percutaneous closure of atrial septal defect in adults: very long-term clinical outcome and effects on aortic and mitral valve function.

AIM: To investigate the very long-term clinical outcomes of atrial septal defect (ASD) percutaneous closure in adult patients and to evaluate the 12-month effects of the device on aortic and mitral valve function. METHODS: Over a 12-year period, a total of 110 consecutive patients underwent percutaneous ASD closure. A yearly clinical follow-up was conducted and any adverse event was recorded. In a 55-patient echocardiographic subgroup, the baseline and 12-month aortic and mitral regurgitation rate was recorded. RESULTS: Mean age was 50.9 ± 17 years and 75% of patients were female. Mean ASD echocardiographic dimension was 17.6 ± 6.2 mm (range, 5-36 mm). Procedural success rate was 97%. After a mean follow-up of 61.8 ± 34.9 months (range, 6-167 months), all-cause death occurred in 2 patients (1.8%) and the composite primary outcome of major adverse cardiovascular event (MACE) occurred in 5 patients (4.5%): 2 non-device related cardiac deaths occurred and 3 surgeries were required. The Kaplan-Meier analysis showed an event-free survival at 140 months of 90%. In the 12-month echocardiographic substudy, no case of significant (moderate or severe) new-onset aortic regurgitation was detected, while 1 case (1.8%) of worsening mild-to-moderate aortic regurgitation was described (P=.90). No case of significant new-onset or worsening mitral regurgitation was noted. No patient needed aortic or mitral surgical repair at very long-term follow-up. CONCLUSIONS: Transcatheter ASD closure is a safe procedure with satisfactory very long-term clinical outcomes. The ASD device does not significantly affect aortic and mitral valve function.