Pulmonary Artery Denervation for Patients With Residual Pulmonary Hypertension After Pulmonary Endarterectomy.

BACKGROUND: Pulmonary artery denervation (PADN) procedure has not been applied to patients with residual chronic thromboembolic pulmonary hypertension (CTEPH) after pulmonary endarterectomy (PEA). OBJECTIVES: This study sought to assess the safety and efficacy of PADN using remote magnetic navigation in patients with residual CTEPH after PEA. METHODS: Fifty patients with residual CTEPH despite medical therapy at least 6 months after PEA, who had mean pulmonary artery pressure ≥25 mm Hg or pulmonary vascular resistance (PVR) > 400 dyn‧s‧cm-5 based on right heart catheterization were randomized to treatment with PADN (PADN group; n = 25) using remote magnetic navigation for ablation or medical therapy with riociguat (MED group; n = 25). In the MED group, a sham procedure with mapping but no ablation was performed. The primary endpoint was PVR at 12 months after randomization. Key secondary endpoint included 6-min walk test. RESULTS: After PADN procedure, 2 patients (1 in each group) developed groin hematoma that resolved without any consequences. At 12 months, mean PVR reduction was 258 ± 135 dyn‧s‧cm-5 in the PADN group versus 149 ± 73 dyn‧s‧cm-5 in the MED group, mean between-group difference was 109 dyn‧s‧cm-5 (95% confidence interval: 45 to 171; p = 0.001). The 6-min walk test distance was significantly increased in the PADN group as compared to distance in the MED group (470 ± 84 m vs. 399 ± 116 m, respectively; p = 0.03). CONCLUSIONS: PADN in patients with residual CTEPH resulted in substantial reduction of PVR at 12 months of follow-up, accompanied by improved 6-min walk test.

Long-term suppression of atrial fibrillation by botulinum toxin injection into epicardial fat pads in patients undergoing cardiac surgery: Three-year follow-up of a randomized study.

BACKGROUND: Botulinum toxin (BTX) injections into epicardial fat pads in patients undergoing coronary artery bypass grafting (CABG) has resulted in suppression of atrial fibrillation (AF) during the early postoperative period through 1-year of follow-up in a pilot program. OBJECTIVE: The purpose of this study was to report 3-year AF patterns by the use of implantable cardiac monitors (ICMs). METHODS: Sixty patients with a history of paroxysmal AF and indications for CABG were randomized 1:1 to either BTX or placebo injections into 4 posterior epicardial fat pads. All patients received an ICM with regular follow-up for 3 years after surgery. The primary end point of the extended follow-up period was incidence of any atrial tachyarrhythmia after 30 days of procedure until 36 months on no antiarrhythmic drugs. The secondary end points included clinical events and AF burden. RESULTS: At the end of 36 months, the incidence of any atrial tachyarrhythmia was 23.3% in the BTX group vs 50% in the placebo group (hazard ratio 0.36; 95% confidence interval 0.14-0.88; P = .02). AF burden at 12, 24, and 36 months was significantly lower in the BTX group than in the placebo group: 0.22% vs 1.88% (P = .003), 1.6% vs 9.5% (P < .001), and 1.3% vs 6.9% (P = .007), respectively. In the BTX group, 2 patients (7%) were hospitalized during follow-up compared with 10 (33%) in the placebo group (P = .02). CONCLUSION: Injection of BTX into epicardial fat pads in patients undergoing CABG resulted in a sustained and substantial reduction in atrial tachyarrhythmia incidence and burden during 3-year follow-up, accompanied by reduction in hospitalizations.

Prophylactic pulmonary vein isolation during isthmus ablation for atrial flutter: Three-year outcomes of the PREVENT AF I study.

INTRODUCTION: The PREVENT AF I study demonstrated that prophylactic pulmonary vein isolation (PVI) in patients with pure typical atrial flutter (AFL) resulted in substantial reduction of new-onset atrial fibrillation (AF) during 1-year follow-up as assessed by continuous implantable cardiac monitor (ICM). The objective of this study was to assess 3-year outcomes. METHODS AND RESULTS: Fifty patients with documented AFL were randomized to either cavotricuspid isthmus (CTI) ablation alone (n = 25) or CTI with concomitant PVI (n = 25). The primary endpoint of the study was the occurrence of any atrial tachyarrhythmia with the monthly burden exceeding 0.5% on the ICM. At the end of 3 years, freedom from any atrial tachyarrhythmia was 48% (95% confidence interval [CI]: 32-72%) in the CTI plus PVI group as compared to 20% (95% CI: 9-44%) in the CTI-only group (P = 0.01). Freedom from redo procedures was also higher: 92% (95% CI: 82-100%) versus 68% (95% CI: 52-89%), respectively (P = 0.027). The 3-year AF burden favored the combined ablation group: 6.2% versus 16.8% (P = 0.03). In the CTI-only group, 12 (48%) patients were hospitalized compared to 4 (16%) in the PVI + CTI group (P = 0.03). Two patients in the CTI-only group developed stroke with no serious adverse events in the PVI + CTI group. CONCLUSION: Prophylactic PVI in patients with only typical AFL resulted in a significant reduction of new-onset AF and burden during long-term follow-up as assessed by ICM, with consequent reduction in hospitalizations and need to perform repeat ablation for AF.

Effect of left atrial appendage excision on procedure outcome in patients with persistent atrial fibrillation undergoing surgical ablation.

BACKGROUND: Catheter ablation is less successful for treatment of persistent atrial fibrillation (PersAF) than for paroxysmal atrial fibrillation. Some studies suggest that left atrial appendage (LAA) isolation in addition to pulmonary vein isolation (PVI) is required to maximize the benefits for PersAF after ablation. OBJECTIVE: The purpose of this study was to compare the efficacy and safety of 2 surgical ablation approaches for PersAF via video-assisted thoracoscopy: PVI + box lesion and PVI + box lesion + LAA excision. METHODS: We randomly assigned 176 patients with PersAF to video-assisted thoracoscopic surgical ablation with PVI + box lesion (88 patients) or PVI + box lesion + LAA excision (88 patients). The primary endpoint was freedom from any documented atrial arrhythmia lasting >30 seconds after a single ablation procedure without antiarrhythmic drug (AAD). RESULTS: After 18 months of follow-up, 61 of 86 patients (70.9%) assigned to PVI + box lesion were free from recurrent atrial fibrillation compared to 64 of 87 patients (73.6%) assigned to PVI + box lesion + LAA excision after a single ablation procedure without AAD (P = .73). Freedom from any atrial arrhythmia after a single procedure with or without AAD was also nonsignificant (70.9% vs 74.7%, respectively). There were no significant differences between groups with regard to adverse events, including death, transient ischemic attack, stroke, pneumothorax, and hydrothorax. CONCLUSION: Among patients with PersAF, no reduction in the rate of recurrent atrial fibrillation was found when LAA excision was performed in addition to PVI and box lesion during surgical ablation.

Cardiac resynchronization therapy combined with coronary artery bypass grafting in ischaemic heart failure patients: long-term results of the RESCUE study.

OBJECTIVES: Totally epicardial cardiac resynchronization therapy (CRT) is a novel treatment modality for patients with heart failure (HF) and systolic dyssynchrony undergoing coronary artery bypass grafting (CABG). In this study, we have prospectively evaluated the long-term outcomes of totally epicardial CRT. METHODS: Between September 2007 and June 2009, one hundred and seventy-eight patients were randomly assigned to the CABG alone group (n = 87) and CABG with concomitant epicardial CRT implantation (n = 91). The primary end-point of the study was all-cause mortality in the two groups between the day of surgery and 13 August 2013 (common closing date). The secondary outcomes included mode of death, adverse cardiac events and lead performance. RESULTS: The mean follow-up was 55 ± 10.7 months. According to per-protocol analysis with treatment as a time-dependent variable to account for conversion from CABG to CABG + CRT, there were 24 deaths (35.8%) in the CABG group and 17 deaths (15.3%) in the CABG + CRT group. When compared with CABG alone, concomitant CRT was associated with reduced risk of both all-cause mortality [hazard ratio (HR) 0.43, 95% confidence interval (CI) 0.23-0.84, P = 0.012] and cardiac death (HR 0.39, 95% CI 0.21-0.72, P = 0.002). Eleven (12.6%) sudden deaths were observed in the CABG group in comparison with 4 (4.4%) in the CABG + CRT group (P = 0.048). Hospital readmission was required for 9 (9.9%) patients in CABG + CRT group and for 25 (28.7%) patients in the CABG group (P = 0.001). There were 4 (1.5%) epicardial lead failures. CONCLUSIONS: The results of our study suggest that the procedure of CABG and totally epicardial CRT system implantation is safe and significantly improves the survival of patients with HF and dyssynchrony during long-term follow-up. CLINICAL TRIAL REGISTRATION: NCT 00846001 (http://www.clinicaltrials.gov).