Sandro Gelsomino

Small-dose recombinant activated factor VII (NovoSeven) in cardiac surgery.

Recombinant activated factor VII (rFVIIa) has been used at different doses in cardiac surgery patients. We tested the efficacy of small-dose rFVIIa in patients with intractable bleeding after cardiac surgery. The study group comprised 15 cardiac surgery patients with intractable bleeding treated with small-dose (1.2 mg) rFVIIa as a slow IV bolus at the end of complete step-by step transfusion protocol. Fifteen matched patients undergoing the same transfusion protocol in the pre-rFVIIa era represented the control group. Blood loss at the end of the transfusion protocol was a primary outcome. Median, 25th–75th 24-h blood loss percentiles were 1685 (1590–1770) mL versus 3170 (2700–3850) mL in study group and controls, respectively (P = 0.0004). Transfused red blood cells, fresh-frozen plasma, and platelets in the study group and controls were as follows: 7 (4–8) U versus 18 (12–21) U (P = 0.001); 7.5 (6–11) U versus 11 (9–15) U (P = 0.003); 0 (0–4) U versus 9 (6–13) U (P = 0.001). In addition, significant improvements of prothrombin time (P = 0.015), international normalized ratio (P = 0.006), activated partial prothrombin time (P = 0.01), and platelet count (P = 0.003) were detected in the study group versus controls. Finally, patients receiving rFVIIa showed a reduced intensive care unit length of stay (&khgr;2 = 15.9, P = 0.0001) and had infrequent surgical re-exploration (&khgr;2 = 16.2,P < 0.0001). Small-dose rFVIIa showed satisfactory results in cardiac patients with intractable bleeding. Further randomized studies are necessary to confirm our findings.

Minimally invasive surgical treatment of lone atrial fibrillation: Early results of hybrid versus standard minimally invasive approach employing radiofrequency sources

BACKGROUND We compared short-term results of a hybrid versus a standard surgical bilateral thoracoscopic approach employing radiofrequency (RF) sources in the surgical treatment of lone atrial fibrillation (LAF). METHODS Between January 2008 and July 2010 sixty-three consecutive patients with LAF underwent minimally invasive surgery. Thirty-five (55.5%) underwent surgery with the hybrid approach whereas 28 (45.5%) underwent bilateral thoracoscopic standard procedure (no-hybrid group). All patients underwent continuous 7-day Holter Monitoring (HM) at 3 months, 6 months and 1 year. RESULTS At 1 year, 91.4% and 82.1% (time-related prevalence 5.2% vs.6.0% [p=0.56]) of the patients were free of AF and AAD. The hybrid group yielded better results in long standing persistent AF (8.2% [time related prevalence 81.8% vs. 44.4%, p=0.001] vs.14.9%, p=0.04). One-year success rates were 87.5% vs. 100% (p=0.04) in persistent [time related prevalence 3.8% vs. 0%, p<0.001] and 87.5% vs. 100% (p=0.04) in paroxysmal AF [time related prevalence 3.2% vs. 0%, p<0.001] in the two groups. One-year prevalence of Warfarin use was significantly higher in the hybrid group (29.0% [26.2-33.1] and 13.4% [9.9-16.3]) with no difference by AF type. LA reverse remodeling occurred in 81.7% (n=30) of hybrid patients and 67.8% (n=19) of no-hybrid patients at latest control (p=0.02). Left atrial emptying fraction increased in both groups (50 ± 14%, p<0.001 and 52 ± 12%, p=0.004 in hybrid and no-hybrid, respectively) without differences between groups (p=0.6). CONCLUSIONS The hybrid procedure yielded excellent results in long-standing persistent AF. Our findings need to be confirmed by further larger studies.

Insights on left ventricular and valvular mechanisms of recurrent ischemic mitral regurgitation after restrictive annuloplasty and coronary artery bypass grafting

BACKGROUND We investigated leaflet and subvalvular configurations to identify mechanisms leading to recurrent mitral regurgitation after combined undersized mitral annuloplasty and coronary artery bypass and to preoperatively recognize patients who are unlikely to benefit from this approach. METHODS Among 261 subjects with chronic ischemic mitral regurgitation undergoing undersized annuloplasty and coronary bypass surgery at one institution between September 2001 and September 2007, 31 were excluded: 4 had intraoperative annuloplasty failure, 12 showed residual regurgitation, and 15 had incomplete echocardiograms available. The study population consisted of 230 patients who were divided into 2 groups: patients without (group 1, n = 176) or with (group 2, n = 54) late recurrent mitral regurgitation. Fifty healthy subjects were used as control subjects. Serial echocardiographic analysis was performed preoperatively, at discharge, and at follow-up appointments (early: median, 6 months [interquartile range, 5-6 months; late: median, 33 months [interquartile range, 17-51 months]). RESULTS Subjects with late regurgitation had preoperatively more symmetric tethering (P < .001), more accentuated anterior mitral leaflet tethering (P < .001), and more restricted anterior leaflet excursion (P = .003) than patients in group 1. Postoperatively, tethering of the posterior leaflet increased (P < .001) and was predominant in both groups, whereas tethering of the anterior leaflet was reduced at discharge (P = .01 and P = .03, respectively), remaining constant afterward. Multivariable analysis showed an anterior tethering angle of 39.5 degrees or greater (P < .001), an anterior/posterior tethering angle ratio of 0.76 or greater (P < .001), an anterior leaflet excursion angle of 35 degrees or less (P = .001), and a coaptation height of 11 mm or greater (P = .04) to be predictors of recurrent mitral regurgitation. CONCLUSIONS Preoperative symmetric tethering with anterior mitral leaflet predominance was strongly associated with recurrence of mitral regurgitation. Measures of leaflet tethering resulted in fundamental findings to identify ischemic patients who can really benefit from restrictive annuloplasty. Further larger studies are necessary to confirm our results.

Left Ventricular Reverse Remodeling After Undersized Mitral Ring Annuloplasty in Patients With Ischemic Regurgitation

BACKGROUND Long-term durability of combined coronary artery bypass grafting and of undersized mitral ring annuloplasty (UMRA) is uncertain. A considerable number of patients show recurrent regurgitation. This study examines the difference in the benefit of UMRA on clinical end points and recurrence of mitral regurgitation between responders and nonresponders of left ventricular reverse remodeling. METHODS Study eligibility criteria were fulfilled by 204 patients with chronic ischemic mitral regurgitation (CIMR) who survived combined coronary artery bypass grafting and reductive annuloplasty between September 2001 and September 2006. Patients underwent echocardiography preoperatively, at discharge, and at follow-up appointments (100% complete). Median early follow-up was 6 months (interquartile range [IRQ], 3 to 8 months; late follow-up, 35 months (IRQ, 21 to 50 months). Reverse remodeling was considered a reduction in left ventricular end systolic volume index exceeding 15%. RESULTS There were 84 responders (41.2%) of reverse remodeling (age, 68 +/- 7.4 years; 51 men) and 120 nonresponders (58.8%; age, 67 +/- 7.6 years; 78 men). Nonresponders had a higher recurrence of mitral regurgitation (p < 0.001), higher reoperation rate for failed repair (p < 0.001), and significantly larger left ventricular volumes and dimension at any study point (p < 0.001), with significant late increase of sphericity indexes exceeding preoperative values (p < 0.001). At multivariable analysis, a baseline myocardial performance index of less than 0.90 (p < 0.001), a systolic sphericity index of less than 0.72 (p < 0.001), and wall motion score index of less than 1.59 (p = 0.003) were independent predictors of reverse remodeling. CONCLUSIONS Our experience suggests that more information on possible echo predictors of an inadequate result may improve preoperative decision making of CIMR patients for UMRA.

Hybrid thoracoscopic and transvenous catheter ablation of atrial fibrillation

The hybrid approach combines an epicardial ablation with a percutaneous endocardial ablation in a single-step or sequential procedure. This study provides an overview of the hybrid procedure for the treatment of stand-alone atrial fibrillation (AF). Papers selected for this review were identified on PubMed and the final selection included nine studies. The total number of patients was 335 (range 15-101). Mean age ranged from 55.2 to 62.9 years. The hybrid approach achieved satisfactory results, with AF-antiarrhythmic drug-free success rates higher than those in isolated procedures. In particular, the bilateral approach with a bipolar device showed a high success rate independently of the AF type and seems to be the better choice for the hybrid procedure. Despite good preliminary results, large, multicentre trials of hybrid AF ablation that target a population of patients with long-standing persistent disease are necessary to establish whether this approach may represent, in the future, a gold-standard treatment for AF.

Minimal invasive surgery for atrial fibrillation: an updated review

AIMS Despite its proven efficacy, the Cox-Maze III procedure did not gain widespread acceptance for the treatment of stand-alone atrial fibrillation (SA-AF) because of its complexity and technical difficulty. Surgical ablation for SA-AF can now be successfully performed utilizing minimally invasive surgery (MIS). This study provides an overview of state-of-the-art MIS for the treatment of SA-AF. METHODS AND RESULTS Studies selected for this review were identified on PUBMED and exclusion and inclusion criteria were applied to select the publication to be screened. Twenty-eight studies were included; 27 (96.4%) were observational in nature whereas 1 was prospective non-randomized. The total number of patients was 1051 (range 14-114). Mean age ranged from 45.3 to 67.1 years. Suboptimal results were obtained when employing microwave and high focused ultrasound energies. In contrast, MIS ablation of SA-AF achieved satisfactory 1-year results when the bipolar radiofrequency was employed as energy source, with antiarrhythmic drug-free success rate comparable to percutaneous catheter ablation (PCA). The success rate in paroxysmal was even higher than in PCA. In contrast, ganglionated plexi ablation and left atrial appendage removal seem not to influence the recurrence of AF and the occurrence of postoperative thromboembolic events. CONCLUSION Minimally invasive surgery ablation of SA-AF achieved satisfactory 1-year results when the bipolar radiofrequency was employed. Nevertheless, the relatively high complication rate reported suggest that such techniques require further refinement. Finally, the preliminary results of the hybrid approach are promising but they need to be confirmed.

The Italian study of the Mitroflow postoperative results (ISTHMUS): a 20-year, multicenter evaluation of Mitroflow pericardial bioprosthesis

OBJECTIVE A multicentre experience with the Mitroflow pericardial bioprosthesis has been evaluated longitudinally over a 20-year period. METHODS From 1988 through 2008, 1591 patients (mean age, 75.3±6.8 years, and 60.1% female) from 12 centres had a Mitroflow in the aortic position. Concomitant coronary artery bypass was performed in 41.9% (n=666) of patients, urgency/emergency surgery in 9.5% (n=152) and replacement of degenerated prosthesis in 2.3% (n=36). Follow-up (7.447 patient-years) was 99.2% complete. Median follow-up was 61.9 months (interquartile range (IQR) 30.8-90.9 months). The study was carried out following American Association for Thoracic Surgery/Society for Thoracic Surgeons/European Association for Cardio-Thoracic Surgery (AATS/STS/EACTS) Guidelines for reporting valve morbidity and mortality. RESULTS The early (30-day) mortality was 6.5% (n=104). Actuarial survival rates at 10, 15 and 18 years were 53%, 34% and 27%, respectively (2.2 patient/year). Re-operation was required in 96 patients (5.9%), of whom 59 patients (3.7%) for structural valve degeneration. Actuarial freedom from prosthetic valve degeneration at 18 years was 65.5% (78% in patients>70 years) with a linearised rate of 1.4 patient/year (0.8 patient/year in patients>70 years). At 18 years, freedom from embolism was 82% (0.9 patient/year), freedom from valve endocarditis was 89% (0.6 patient/year) and freedom from bleeding episodes was 95% (0.2 patient/year), respectively. CONCLUSIONS This independent multicentre study indicates that the Mitroflow pericardial bioprosthesis provides favourable long-term postoperative results with a low rate of valve-related events and need of re-intervention, particularly in patients older than 70 years.

The hybrid approach for the surgical treatment of lone atrial fibrillation: One-year results employing a monopolar radiofrequency source

BackgroundThe hybrid technique combines a mono or bilateral epicardial approach with a percutaneous endocardial ablation in a single-step procedure. We present our early results with this technique employing a monopolar radiofrequency source through a right thoracoscopy in patients with lone atrial fibrillation (LAF).MethodsBetween June 2009 and December 2010 nineteen consecutive patients (mean 60.8 ± 8.6 years, 84.2% male) underwent right unilateral minimally invasive hybrid procedure for LAF at our Institution. Ten patients (52.6.6%) had long-standing persistent AF while four (21.1%) had persistent and five (26.3%) paroxysmal AF. All patients were followed-up according the Heart Rhythm Society/European Heart Rhythm Association/European Cardiac Arrhythmia Society (HRS/EHRA/ECA) and Society of Thoracic Surgeon (STS) guidelines.ResultsThere were neither early nor late deaths. It was possible to complete all the procedures as planned without any conversion to cardiopulmonary bypass. No patient died during the follow up. At one year, 7/19 (36.8%) patients were in sinus rhythm with no episode of AF and off antiarrhythmic drugs (AAD). Time-related prevalence of postoperative AF peaked at 44.4% (41.3–47.4) at two weeks, was 30.4% (27.3–34.9) at three months, fell to 14.2% (11.6–18.1) by 6 months and was 13.3% (11.0–17.4) at 12 months Among patients with long-standing persistent (LSP) AF, 20% (2/10) were in Sinus rythm and off AAD. One-year success rates were 50% (2/4) in persistent and 60% (3/5) in paroxysmal AF. At 12 months estimated prevalence of antyarrhythmic drugs and Warfarin use were 26% (22.4–33.1) and 48% (37.2–53.2), respectively.ConclusionsOne year results combining the percutaneous endocardial with the right thoracoscopic epicardial technique were, in our experience, not satisfactory, particularly in patients with LSP and persistent AF. Our findings need to be confirmed by larger studies.

Effectiveness and safety of simultaneous hybrid thoracoscopic and endocardial catheter ablation of lone atrial fibrillation

BACKGROUND We evaluated the safety and effectiveness of the hybrid thoracoscopic endocardial epicardial technique for the treatment of lone atrial fibrillation. METHODS Between 2009 and 2012, a cohort of 78 consecutive patients (median age 60.5 years, 77% male) underwent ablation of atrial fibrillation (AF) as a stand-alone procedure using a thoracoscopic, hybrid epicardial-endocardial technique. All patients underwent continuous 7-day Holter monitoring at 3 months, 6 months, 1 year and yearly thereafter. All patients reached 1-year follow-up. Median follow-up was 24 months [interquartile range 12-36]. RESULTS No death or conversion to cardiopulmonary bypass occurred. No patient demonstrated paralysis of the phrenic nerve. Overall, the incidence of perioperative complications was 8% (n=6). At the end of follow-up, sixty-eight patients (87%) were in sinus rhythm (SR) with no episode of AF, atrial flutter or atrial tachycardia lasting longer than 30 seconds and off antiarrhythmic drugs (ADD). Among patients with long-standing persistent AF, 15 (100%) were in SR and off AAD. Success rates were 82% (n=28) in persistent and 76% (n=22) in paroxysmal AF (P=0.08). No patient died and no thromboembolic/bleeding events or procedure-related complications occurred during the follow-up. CONCLUSIONS Thoracoscopic hybrid epicardial endocardial technique proved to be effective and safe in the treatment of LAF and to represent an important new suitable option to treat stand-alone AF. Our findings need to be confirmed by further larger studies.

Venoarterial extracorporeal membrane oxygenation for acute fulminant myocarditis in adult patients: A 5-year multi-institutional experience

BACKGROUND Acute fulminant myocarditis (AFM) may represent a life-threatening event, characterized by rapidly progressive cardiac compromise that ultimately leads to refractory cardiogenic shock or cardiac arrest. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) provides effective cardiocirculatory support in this circumstance, but few clinical series are available about early and long-term results. Data from a multicenter study group are reported which analyzed subjects affected by AFM and treated with VA-ECMO during a 5-year period. METHOD From hospital databases, 57 patients with diagnoses of AFM treated with VA-ECMO in the past 5 years were found and analyzed. Mean age was 37.6 ± 11.8 years; 37 patients were women. At VA-ECMO implantation, cardiogenic shock was present in 38 patients, cardiac arrest in 12, and severe hemodynamic instability in 7. A peripheral approach was used with 47 patients, whereas 10 patients had a central implantation or other access. RESULTS Mean VA-ECMO support was 9.9 ± 19 days (range, 2 to 24 days). Cardiac recovery with ECMO weaning was achieved in 43 patients (75.5%), major complications were observed in 40 patients (70.1%), and survival to hospital discharge occurred in 41 patients (71.9%). After hospital discharge (median follow-up, 15 months) there were 2 late deaths. The 5-year actual survival was 65.2% ± 7.9%, with recurrent self-recovering myocarditis observed in 2 patients (at 6 and 12 months from the first AFM event), and 1 heart transplantation. CONCLUSIONS Cardiopulmonary support with VA-ECMO provides an invaluable tool in the treatment of AFM, although major complications may characterize the hospital course. Long-term outcome appears favorable with rare episodes of recurrent myocarditis or cardiac-related events.