Efficacy of a web-based intervention for improving psychosocial well-being in patients with implantable cardioverter-defibrillators: the randomized controlled ICD-FORUM trial.

AIMS: Anxiety, depression, and reduced quality of life (QoL) are common in patients with implantable cardioverter-defibrillators (ICDs). Treatment options are limited and insufficiently defined. We evaluated the efficacy of a web-based intervention (WBI) vs. usual care (UC) for improving psychosocial well-being in ICD patients with elevated psychosocial distress. METHODS AND RESULTS: This multicentre, randomized controlled trial (RCT) enrolled 118 ICD patients with increased anxiety or depression [≥6 points on either subscale of the Hospital Anxiety and Depression Scale (HADS)] or reduced QoL [≤16 points on the Satisfaction with Life Scale (SWLS)] from seven German sites (mean age 58.8 ± 11.3 years, 22% women). The primary outcome was a composite assessing change in heart-focused fear, depression, and mental QoL 6 weeks after randomization to WBI or UC, stratified for age, gender, and indication for ICD placement. Web-based intervention consisted of 6 weeks' access to a structured interactive web-based programme (group format) including self-help interventions based on cognitive behaviour therapy, a virtual self-help group, and on-demand support from a trained psychologist. Linear mixed-effects models analyses showed that the primary outcome was similar between groups (ηp2 = 0.001). Web-based intervention was superior to UC in change from pre-intervention to 6 weeks (overprotective support; P = 0.004, ηp2 = 0.036), pre-intervention to 1 year (depression, P = 0.004, ηp2 = 0.032; self-management, P = 0.03, ηp2 = 0.015; overprotective support; P = 0.02, ηp2 = 0.031), and 6 weeks to 1 year (depression, P = 0.02, ηp2 = 0.026; anxiety, P = 0.03, ηp2 = 0.022; mobilization of social support, P = 0.047, ηp2 = 0.018). CONCLUSION: Although the primary outcome was neutral, this is the first RCT showing that WBI can improve psychosocial well-being in ICD patients.

Stand-alone mapping using different transluminal mapping catheters--an accurate and safe way to isolate all pulmonary veins with the cryoballoon?

PURPOSE: Cryoballoon isolation of the pulmonary veins (PVI) is an effective and safe method in the treatment of patients with paroxysmal atrial fibrillation (PAF). The circular mapping catheter Achieve® (Medtronic Inc., Minneapolis, USA) can be introduced into the pulmonary vein (PV) through the inner lumen of the balloon catheter, allowing online mapping of the PV electrograms during ablation. We prospectively compared the accuracy of this catheter in both available sizes to a standard circular mapping catheter (SCMC) in order to determine bidirectional PV block. METHODS: Patients with symptomatic PAF underwent cryoballoon ablation using either the Achieve® 15-mm catheter (group 1, 15 patients) or the Achieve® 20 mm (group 2, 15 patients). PV potentials were recorded using Achieve® before, during, and after ablation, and exit block was obtained by pacing from inside the PV. Accuracy of PV potential detection was controlled by a SCMC before and after ablation. RESULTS: Rate of PV which could be isolated exclusively using the Achieve® as guidewire was 98 % (59/60) in group 1 and 93 % (57/60) in group 2. Online signal recording during ablation was possible in 40 and 60 % of PV (p = 0.037), respectively. Final Achieve® diagnosis was accurate in 55/60 (92 %) of the PVs and 12/15 (80 %) of patients in group 1 and 60/60 (100 %) of PV and 15/15 (100 %) of patients in group 2. CONCLUSION: Stand-alone mapping using Achieve® 15 mm resulted in a significant lack of diagnostic accuracy. Achieve® 20 mm provided excellent diagnostic accuracy comparable to a SCMC and should be preferentially used.

Recurrence of paroxysmal atrial fibrillation after cryoisolation of the pulmonary veins. Is a "redo" procedure using the cryoballoon useful?

BACKGROUND: Pulmonary vein (PV) isolation with the cryoballoon technique is an effective and safe method to treat patients with paroxysmal atrial fibrillation (AF). However, the optimal treatment strategy for patients with recurrences after this ablation is unclear. AIMS: The aim of this single centre study was to evaluate the efficacy and safety of a "redo" procedure using the cryoballoon in this patient cohort. The secondary study objectives were to determine the rate of reconduction for individual PVs of the patients undergoing "redo" ablation and potential predictors of persistent PV isolation (PVI). METHODS: Between April 2006 and September 2009, all patients with paroxysmal AF recurrences after cryoballoon ablation a "redo" ablation with the cryoballoon was offered. PV conduction was determined and cryoapplications were performed in all reconnected PVs. Every 3 months, 7-day Holter ECG, symptom-driven transtelephonic ECG recordings, and questionnaires were collected for 12 months. RESULTS: Forty-seven patients underwent "redo" cryoballoon ablation. In all these patients, at least one PV with reconduction was found. Recurrent conduction was documented in 63 % of the left superior PV, 56 % of the left inferior PV, 43 % of the right superior PV, and 56 % of the right inferior PV. In 28 of the 47 patients (60 %), no AF recurrence was detectable during the 12-month follow-up (after 3 months blanking period). Rate of severe complications was low and not significantly different from that of the initial ablations. CONCLUSION: "Redo" ablation using cryoballoon technology may be an effective and safe method to treat patients with recurrence of paroxysmal AF after cryoballoon PVI.