Sequential hybrid ablation vs. surgical CryoMaze alone for treatment of atrial fibrillation: results of multicentre randomized controlled trial.

AIMS: Data on the hybrid atrial fibrillation (AF) treatment are lacking in patients with structural heart disease undergoing concomitant CryoMaze procedures. The aim was to assess whether the timely pre-emptive catheter ablation would achieve higher freedom from AF or atrial tachycardia (AT) and be associated with better clinical outcomes than surgical ablation alone. METHODS AND RESULTS: The trial investigated patients with non-paroxysmal AF undergoing coronary artery bypass grafting and/or valve repair/replacement with mandatory concomitant CryoMaze procedure who were randomly assigned to undergo either radiofrequency catheter ablation [Hybrid Group (HG)] or no further treatment (Surgery Group). The primary efficacy endpoint was the first recurrence of AF/AT without class I or III antiarrhythmic drugs as assessed by implantable cardiac monitors. The primary clinical endpoint was a composite of hospitalization for arrhythmia recurrence, worsening of heart failure, cardioembolic event, or major bleeding. We analysed 113 and 116 patients in the Hybrid and Surgery Groups, respectively, with a median follow-up of 715 (IQR: 528-1072) days. The primary efficacy endpoint was significantly reduced in the HG [41.1% vs. 67.4%, hazard ratio (HR) = 0.38, 95% confidence interval (CI): 0.26-0.57, P < 0.001] as well as the primary clinical endpoint (19.9% vs. 40.1%, HR = 0.51, 95% CI: 0.29-0.86, P = 0.012). The trial groups did not differ in all-cause mortality (10.6% vs. 8.6%, HR = 1.17, 95%CI: 0.51-2.71, P = 0.71). The major complications of catheter ablation were infrequent (1.9%). CONCLUSION: Pre-emptively performed catheter ablation after the CryoMaze procedure was safe and associated with higher freedom from AF/AT and improved clinical outcomes.

Sequential hybrid ablation versus surgical CryoMaze alone for treatment of atrial fibrillation (SurHyb Trial): a protocol of the multicentre randomized controlled trial.

BACKGROUND: Atrial fibrillation is common in patients with structural heart disease who are undergoing cardiac surgery. Surgical CryoMaze has been shown to be an effective treatment in several trials, but success rates have varied considerably, between 47-95%. The sequential hybrid approach, combining surgical CryoMaze followed by radiofrequency catheter ablation, can achieve high freedom from atrial arrhythmias. However, in patients with concomitant surgical atrial fibrillation treatment, data comparing the hybrid approach to CryoMaze alone are lacking. METHODS: The SurHyb study was designed as a prospective, open-label, multicentre randomized trial. Patients with non-paroxysmal atrial fibrillation who were scheduled for coronary artery bypass grafting or valve repair/replacement were randomized to either surgical CryoMaze alone or surgical CryoMaze followed by radiofrequency catheter ablation 3 months post-surgery. The primary outcome measure was arrhythmia-free survival without class I or III antiarrhythmic drugs, which has been evaluated using implantable cardiac monitors. CONCLUSIONS: This is the first randomized study that compares concomitant surgical CryoMaze alone with the staged hybrid surgical CryoMaze followed by catheter ablation, in patients with non-paroxysmal atrial fibrillation using rigorous rhythm monitoring. The results may contribute to the optimization of the treatment in patients undergoing concomitant CryoMaze for atrial fibrillation.

Use of Amplatzer occluders for treatment of aorto-pulmonary fistulas - case and review of the literature.

INTRODUCTION: the use of amplatzer occluder family in daily clinical practice has already overcome on-label indications, with growing clinical experience and the technological evolution of devices. Areas covered: We present the case of a patient with a very rare complication following proximal aortic surgery treated using a unique strategy. A huge pseudoaneurysm around an ascending aortic prosthesis ruptured into the right pulmonary artery. A hybrid treatment strategy consisting of percutaneous closure of the fistula followed by cardiosurgery was chosen due to the patient's poor haemodynamic condition. We also review current clinical experience of endovascular treatment of aortopulmonary fistulas by searching case reports in PubMed. Expert commentary: Closure of the APF using an Amplatzer occluder via the antegrade venous approach is feasible, and may improve the haemodynamic conditions and decrease the risk of subsequent cardiac surgery.

An embolus in the right atrium caught in the Chiari network and resistant to thrombolysis.

Case report is presented, which describes a patient with thromboemboli trapped in the Chiari network within the right heart and resistant to thrombolysis. The right atrial masses were completely removed under cardiopulmonary bypass. Histological evaluation confirmed a mixed thromboemboli, with thrombus structures showing signs of organization and surrounded by a fibrous capsule. A heterozygous methylenetetrahydrofolate reductase gene polymorphism was found, and the plasma level of the plasminogen activator inhibitor type-1 (PAI-1) was 50% higher than the normal upper limit. In this presented case, the Chiari network displayed a protective function, but the expansion and organization of the thromboembolus caught there made it resistant to lytic therapy. Another important factor which could have influenced the resistance to thrombolysis was the high level of PAI-1. PAI-1 is the primary physiologic inhibitor of plasminogen activation in blood. Elevated pre-treatment levels of PAI-1 may reduce the efficacy of thrombolytic therapy by preventing or retarding clot dissolution. The patient's DNA was tested for a common single-base-pair polymorphism (four or five guanine bases) in the promoter region of the gene (4G/5G), but the presence of this variant allele was not confirmed: the patient was homozygous for the 5G allele (5G/5G genotype).

Rescue peri-operative management of the patient with giant electrical storm and severe left ventricular dysfunction: support by levosimendan and intraaortic balloon counterpulsation.

We present a case of a 62-year-old male patient (coronary heart disease, and stenosis of aortic valve) with severe left ventricular dysfunction (left ventricular ejection fraction 20%, left ventricular end-diastolic diameter 80 mm, end-diastolic volume 329 ml) who developed giant electrical storm (on the whole 115 episodes of pulseless ventricular tachycardia treated by antiarrhythmics and electrical discharges) with low-elevation of cardiac biomarkers. The patient was referred to emergent cardiac surgery (double coronary bypass grafting, aortic valve replacement, and implantation of left ventricular epicardial electrode). Levosimendan and intraaortic balloon counterpulsation were used for successful weaning from the cardiopulmonary bypass; no other arrhythmia appeared in the post-bypass period. Postoperatively no arrhythmic events were detected, and repeated echocardiographic examinations of the patient in good general condition showed gradual improvement of left ventricular ejection fraction (30-35%), likewise in other parameters (left ventricular end-diastolic diameter 72 mm, end-diastolic volume 285 ml).

Fibrinolytic inhibitors in off-pump coronary surgery: a prospective, randomized, double-blind TAP study (tranexamic acid, aprotinin, placebo).

OBJECTIVE: To evaluate and compare hemostatic effects of tranexamic acid vs. aprotinin vs. placebo in off-pump coronary artery bypass (OPCAB) surgery and, in addition, to assess the safety of fibrinolytic inhibitors therapies. METHODS: In a prospective, randomized, double-blind study finally 91 patients undergoing OPCAB were investigated (group A, n=32, tranexamic acid 1g before skin incision and continuously 200mg/h; group B, n=29, aprotinin 1,000,000IU before skin incision and 250,000IU/h; group C, n=30, placebo). RESULTS: Highly significant inter-group differences were found in cumulative blood loss within 4h (geometric means [95% confidence intervals]-group A: 89.3 [72.7, 109.8] mL, group B: 72.3 [49.2, 106.3] mL and group C: 192.3 [151.8, 243.5] mL) (P<0.001), within 8h (group A: 152.1 [120.7, 191.6] mL, group B: 130.3 [88.1, 192.8] mL and group C: 283.8 [226.0, 356.3] mL) (P=0.001), and within 24h postoperatively (group A: 410.3 [337.6, 498.6] mL, group B: 345.8 [256.0, 398.2] mL and group C: 619.8 [524.3, 732.8] mL) (P<0.001). At all time points, placebo group C was significantly distinct from the groups treated with fibrinolytic inhibitors (groups A and B). However, no differences between groups A and B were found. Both mean hemoglobin and hematocrit values 24h postoperatively were different between the groups (P=0.018 and P=0.077, respectively), acheiving the lowest value in group C. Number of re-transfuzed patients was highest in group C, but without statistical significance (either packed red blood cells, P=0.119 or fresh-frozen plasma, P=0.118). We observed one postoperative myocardial infarction in aprotinin treated group B and one temporary postoperative myocardial ischemia in placebo group C, no cerebrovascular or pulmonary embolism was noticed. Treated groups A and B did not demonstrate postoperative increase in mean levels of myocardial enzymes, compared with group C. Significantly higher mean values of D-dimer were found in group C 24h postoperatively (P<0.001). CONCLUSIONS: Both tranexamic acid and aprotinin seem to be similarly effective in the reduction of postoperative blood loss in OPCAB. Tranexamic acid appears to be cost-effective and safe alternative to aprotinin.

One-year coronary bypass graft patency: a randomized comparison between off-pump and on-pump surgery angiographic results of the PRAGUE-4 trial.

BACKGROUND: Off-pump coronary bypass surgery has become a widely used technique during recent years. However, limited data are available with regard to 1-year patency of bypass grafts implanted on the beating heart in unselected consecutive bypass surgery candidates. The aim of this study was to compare 1-year angiographic patency of bypass grafts done on the beating heart (off pump) with those done classically (on pump). METHODS AND RESULTS: The PRAGUE-4 trial randomized 400 consecutive nonselected cardiac surgery candidates into group A (on pump; n=192) and group B (off pump; n=208). One-year follow-up coronary angiography was done in 255 patients. The arterial graft patency after 1 year was 91% in both groups. Saphenous graft patency was 59% (on pump) versus 49% (off pump; P=NS). Saphenous graft patency per patient was lower in the off-pump group: 0.7 patent anastomosis per patient versus 1.1 patent anastomosis in the on-pump group (P<0.01). There were 46% on-pump patients with all grafts patent versus 52% off-pump patients (P=NS). Grafts anastomosed distally to collateralized chronic total occlusions of native coronary arteries remained patent in 100% on the left anterior descending artery compared with 23% on other arteries (P<0.0001). CONCLUSIONS: The patency of arterial coronary bypass grafts done on the beating heart is excellent and equal to grafts done on pump. The off-pump procedure in the unselected patient population results in fewer patent saphenous grafts per patient.

Off-pump versus on-pump coronary surgery: final results from a prospective randomized study PRAGUE-4.

BACKGROUND: Off-pump coronary artery bypass surgery is becoming increasingly popular despite the lack of sufficient evidence from randomized trials. The aim of our prospective, randomized, single-center study was to examine the role of off-pump revascularization among nonselected patients. METHODS: A total of 400 consecutive nonselected patients (mean age 63 years) scheduled for isolated coronary revascularization were randomized by a cardiologist into two groups: A (on-pump) and B (off-pump). The cardiac surgeon was allowed to change the operative technique at any time after randomization. The only exclusion criterion was an emergency procedure. The primary end point was any of the following within 30 days: death, myocardial infarction, stroke, or new renal failure requiring hemodialysis. The study was analyzed on the intention-to-treat principle. RESULTS: The primary end point occurred in 4.9% of patients in group A versus 2.9% in group B (not significant). Mortality was 1.1% in group A versus 2.0% in group B (not significant). Preoperative crossover occurred in 5.4% of patients in each group (not significant). Intraoperative conversion was necessary in 9.8% of patients in group B versus 1.1% of patients in group A (p < 0.001). Group B patients had fewer distal anastomoses (2.3 versus 2.7 in group A; p < 0.001), less blood loss (560 versus 680 mL; p < 0.001), lower postoperative creatine kinase MB levels (0.15 versus 0.56 microkat/L; p < 0.001) and lower total hospital costs (3,451 versus 4,387; p < 0.001). CONCLUSIONS: In our study off-pump technique was applicable in 85% of nonselected patients and is at least as clinically safe and effective as on-pump surgery.