European prospective multicentre study of hybrid thoracoscopic and transcatheter ablation of persistent atrial fibrillation: the HISTORIC-AF trial.

OBJECTIVES: The HISTORIC-AF trial is a prospective, multicentre, single-arm study designed to evaluate the outcomes of a staged endoscopic and transcatheter ablation in patients with stand-alone, persistent or long-standing persistent atrial fibrillation (AF). METHODS: From 2012 to 2015, 100 consecutive patients were enrolled and underwent thoracoscopic left atrial epicardial isolation ('box lesion') followed by transcatheter ablation in case of AF recurrency. The safety end point was the composite outcome of freedom from major adverse events at 30-days, while efficacy end points were: (i) primary: freedom from AF and stable sinus rhythm following isolated thoracospic ablation >60% and (ii) secondary: freedom from AF and stable sinus rhythm >80% following hybrid ablation (as per HRS criteria). RESULTS: No death occurred and surgical thoracoscopic procedure was successfully completed in all patients. Survival free from major adverse events at 30 days was 94%: there were 3 permanent pacemaker implants, 2 episodes of stroke and 1 revision for bleeding. At discharge, 87% of patients were in sinus rhythm. A staged transcatheter ablation was carried out in all patients with AF recurrences at the end of 3 months blanking period (17% of patients). At 12-months follow-up, a stable restoration of sinus rhythm was achieved in 75% and 88% of patients following isolated thoracoscopic ablation and hybrid ablation, respectively. CONCLUSIONS: The HISTORIC-AF trial showed that thoracoscopic isolated surgical ablation reached both the safety and the efficacy end points. Hybrid ablation steadily improved rhythm outcomes and may be considered in the future as the treatment of choice for patients with persistent and long-standing persistent AF. CLINICALTRIALS.GOV IDENTIFIER: NCT01622907.

Endoaortic Clamping Does Not Increase the Risk of Stroke in Minimal Access Mitral Valve Surgery: A Multicenter Experience.

BACKGROUND: Some controversy exists regarding the safety of endoaortic balloon clamping in minimal access isolated mitral valve surgery (MIMVS). The aim of this European multicenter study was to analyze the results in 10 experienced centers and compare the outcomes with published data. METHODS: The most recent 50 consecutive MIMVS cases from 10 European surgeons who had performed at least 100 procedures were prospectively collected and retrospectively analyzed. All procedures were performed through right minithoracotomy with femoral cannulation and endoaortic balloon occlusion. In-hospital and 30-day outcomes were studied. Mortality and stroke rates were compared with published median sternotomy and MIMVS outcomes. RESULTS: Mean age was 63.2 ± 12.5 years, 289 (57.8%) were male, mean logistic European system for cardiac operative risk evaluation was 6.1 ± 6.2, and 53 (10.6%) procedures had cardiac reoperations. Concomitant procedures were performed in 126 (25.9%) cases. Three patients (0.6%) required conversion to full sternotomy. Ten patients (2.0%) necessitated endoaortic balloon clamping conversion (8 to external clamping), and re-exploration for bleeding was necessary in 24 (4.8%) cases. Mean aortic cross-clamp and cardiopulmonary bypass times were 85.6 ± 30.1 and 129.5 ± 40.2 min, respectively, and were significantly longer for concomitant procedures (p < 0.001). There were no aortic dissections and no deep venous thromboses. Operative mortality (none neurologic) and major stroke occurred in 7 (1.4%) and 4 (0.8%) patients, respectively. These rates compared favorably with the published literature on isolated primary mitral valve surgery (MVS) through sternotomy or minithoracotomy (mortality rates 0.2% to 11.6%, stroke rates 0.6% to 4.4%). CONCLUSIONS: Once procedural proficiency is acquired, endoaortic balloon clamping in MIMVS is a safe and effective technique. Despite the fact that this patient cohort also includes combined and redo procedures, the observed mortality and stroke rate compared favorably with the existing literature on primary isolated mitral valve surgery irrespective of the approach.

Cross-sectional survey on minimally invasive mitral valve surgery.

BACKGROUND: Minimally invasive mitral valve surgery (MIMVS) has become a standard technique to perform mitral valve surgery in many cardiac centers. However, there remains a question regarding when MIMVS should not be performed due to an increased surgical risk. Consequently, expert surgeons were surveyed regarding their opinions on patient factors, mitral valve pathology and surgical skills in MIMVS. METHODS: Surgeons experienced in MIMVS were identified through an electronic search of the literature. A link to an online survey platform was sent to all surgeons, as well as two follow-up reminders. Survey responses were then submitted to a central database and analyzed. RESULTS: The survey was completed by 20 surgeons. Overall results were not uniform with regard to contraindications to performing MIMVS. Some respondents do not consider left atrial enlargement (95% of surgeons), complexity of surgery (75%), age (70%), aortic calcification (70%), EuroSCORE (60%), left ventricular ejection fraction (55%), or obesity (50%) to be contraindication to surgery. Ninety percent of respondents believe more than 20 cases are required to gain familiarity with the procedure, while 85% believe at least one MIMVS case needs to be performed per week to maintain proficiency. Eighty percent recommend establishment of multi-institutional databases and standardized surgical mentoring courses, while 75% believe MIMVS should be incorporated into current training programs for trainees. CONCLUSIONS: These results suggest that MIMVS has been accepted as a treatment option for patients with mitral valve pathologies according the expert panel. Initial training and continuing practice is recommended to maintain proficiency, as well as further research and formalization of training programs.

Mid-term results of endoscopic mitral valve repair in combination with endocardial or epicardial ablation.

OBJECTIVE: Concomitant ablative therapy for atrial fibrillation can be effective at converting patients to normal sinus rhythm and at maintaining a regular rhythm for at least 5 years. We provide herein a comparison of an endocardial approach using Cryoablation with an epicardial approach using a suction-based RF ablation technology. METHODS: Between February 2004 and January 2009, 325 patients underwent an endoscopic mitral valve repair. Of those patients, 112 (35%) had a history of atrial fibrillation prior to the procedure, all of whom underwent a concomitant ablation procedure. The first group of 78 concomitant ablation patients underwent a left-sided endocardial ablation procedure using a Cryoablation device. The second group of 34 ablation patients underwent a left-sided epicardial ablation procedure using an internally cooled monopolar RF device. No significant differences existed between groups in the preoperative data. All ablated patients were treated by the same Amiodarone protocol. Patients were followed for a minimum of 6 months for determining each ablated patient's rhythm, medication use, and overall health status. RESULTS: The AF-free rates of group I and group II patients were statistically equivalent for both ablation groups at all evaluation time points. None of the 112 patients treated with endoscopic mitral valve repair and ablative therapy experienced a specific patient injury attributable to ablation; no ablated patients died in hospital following the procedure; there were no esophageal perforations and no coronary artery stenosis due to the ablations in either ablation group. The rate of patients without AF was 74% in group I and 82% in group II in the 6-month follow-up. The group I pacemaker implantation rate of 14% was significantly higher than non-ablated group (4.7%), but the group II rate of 5.9% observed did not differ significantly from the non-ablated group. CONCLUSIONS: It was shown with our results that one succeeds with the en bloc-ablation in treating patients with different kinds of atrial fibrillation with concurrent intervention in the mitral valve reliably and with a high rate. The combination of this procedure with endocardial interventional ablation technologies can possibly develop to a promising strategy in the hybrid therapy of the isolated chronic atrial fibrillation as a standalone procedure.

Intraoperative left atrial ablation (for atrial fibrillation) using a new argon cryocatheter: early clinical experience.

PURPOSE: Recently surgical treatment of atrial fibrillation has gained more popularity and presently is being performed in large numbers of patients. This report describes our early experience in treatment of patients with chronic or paroxysmal atrial fibrillation with a new tool for left atrial cryoablation. DESCRIPTION: From July 2002 through January 2003, 28 patients underwent left atrial cryoablation with the Surgifrost CryoCath. Patients underwent cryotherapy as an isolated procedure (n = 1), in combination with mitral valve surgery (n = 13), or with other surgical procedures (n = 14). In all patients contiguous lesion lines to the orifices of the pulmonary veins connected to the mitral annulus and the atriotomy were created. Surgery was performed through a conventional sternotomy in 8 patients (29%) and a right lateral minithoracotomy using video-assistance in 20 patients (71%). EVALUATION: Postoperatively sinus rhythm was restored in 27 patients (96%). At discharge 82% (23/28) of patients were in sinus rhythm and 18% (5/28) were in atrial fibrillation. Four patients (14%) required pacemaker implantation. There was no in-hospital mortality. At 6-months follow-up (19/28 patients) all were alive and 74% were in stable sinus rhythm, New York Heart Association functional class was 1.2 +/- 0.4. CONCLUSIONS: As indicated by our small and early patient cohort left atrial cryoablation with the Surgifrost argon cryocatheter is effective for the treatment of atrial fibrillation. This new device is technically easy to handle, it can be applied through a median sternotomy or lateral minithoracotomy. Long-term follow-up is necessary to evaluate further rhythm outcome.

Right heart support during off-pump coronary artery bypass surgery--a multi-center study.

BACKGROUND: Off-pump coronary artery bypass (OPCAB) surgery for posterior and inferior wall vessels requires heart displacement, which leads to hemodynamic instability. Based on results indicating that displacement primarily alters right heart function, this study evaluates the safety and efficacy of right heart support during OPCAB surgery to the posterior and inferior wall vessels. METHODS: In a multi-center, prospective study, 25 patients underwent multi-vessel OPCAB surgery. Right heart support was carried out using the Enabler circulatory support system (Hemodynamics Systems Ltd., Upper Yokneam, Israel). Hemodynamic measurements were recorded at baseline and during heart displacement with and without right heart support. RESULTS: No mortality was recorded. Mean graft number was 2.25 +/- 0.36. Inability to position the Enabler system occurred in five cases. Once the Enabler was properly positioned, there was no case of conversion to cardiopulmonary bypass (CPB) due to failure of the Enabler to provide adequate support. Cardiac index (CI) declined from 2.4 +/- 0.5 L/min x /m2 to 1.6 +/- 0.6 L/min x /m2 (p <0.05) during heart displacement and increased to 2.3 +/- 0.6 L/min x /m2 (p <0.05) following Enabler activation. Mean arterial blood pressure (MAP) dropped from 82 +/- 18.6 mmHg to 53.1 +/- 16.6 mmHg (p <0.001) during heart displacement and was restored to 69.8 +/- 19.4 mmHg (p <0.001) with Enabler support. CONCLUSIONS: Heart displacement caused a significant hemodynamic deterioration that was stabilized with right heart support. The Enabler system is safe and effective in facilitating multi-vessel OPCAB surgery. However, there are still serious technical problems during cannula insertion that cause an unacceptable failure rate of device utilization.