Twelve-month efficacy of second-generation cryoballoon ablation for atrial fibrillation performed at community hospitals: results of the German register on cryoballoon ablation in local hospitals (regional).

BACKGROUND: The 12-month follow-up (F/U) efficacy of CBA PVI performed at community hospitals for treatment of symptomatic paroxysmal and persistent atrial fibrillation (AF) is unknown. This study determined the 12-month efficacy of pulmonary vein isolation (PVI) using cryoballoon ablation (CBA) performed at community hospitals with limited annual case numbers. METHODS: This registry study included 983 consecutive patients (pts) from 19 hospitals, each with an annual procedural volume of < 100 PVI procedures/year. Pts underwent CBA PVI for paroxysmal AF (n = 520), persistent AF (n = 423), or redo PVI (n = 40). The primary endpoint was frequency of documented recurrent AF, the occurrence of atrial flutter or tachycardia following a 90-day period after the index ablation and up to 12 months. The frequency of repeat ablation was determined. RESULTS: Isolation of all PVs was documented in 98% of pts at the end of the procedure. Twelve-month F/U data could be obtained in 916 pts. A 24-h ECG registration was performed in 641 pts (70.0%); in 107 pts (16.7%) of them, recurrent AF was documented. The primary endpoint was met in 193 F/U pts (21.1%). It occurred in 80/486 F/U pts with paroxysmal AF (16.4%), and in 107/390 F/U pts with persistent AF (27.4%). Redo PVI was performed in 71 pts (7.8%), and atrial flutter ablation was performed in 12 pts (1.4%). CONCLUSIONS: CBA PVI for paroxysmal or persistent AF can be performed at community hospitals with adequate rates of 12-month symptom freedom and arrhythmia recurrence. The study was registered at the German register of clinical studies (DRKS00016504).

Safety and acute efficacy of cryoballoon ablation for atrial fibrillation at community hospitals.

AIMS: Pulmonary vein isolation (PVI) using cryoballoon ablation (CBA) is an established procedure for treating symptomatic paroxysmal and persistent atrial fibrillation (AF). The safety and efficacy of PVI performed at community hospitals are unknown. We aimed to determine the safety and acute efficacy of PVI using CBA performed at community hospitals with limited annual case numbers. METHODS AND RESULTS: This registry study included 1004 consecutive patients who had PVI performed for symptomatic paroxysmal (n = 563) or persistent AF (n = 441) from January 2019 to September 2020 at 20 hospitals. Each hospital performed fewer than 100 CBA-PVI procedures/year according to local standards. Procedural data, efficacy, and complication rates were determined. The mean number of CBA procedures performed/year at each centre was 59 ± 25. The average procedure time was 90.1 ± 31.6 min and the average fluoroscopy time was 19.2 ± 11.4 min. Isolation of all pulmonary veins was documented in 97.9% of patients. The most frequent reason for not achieving complete isolation was development of phrenic nerve palsy. No hospital deaths were observed. Two patients (0.2%) suffered a clinical stroke. Pericardial effusion occurred in six patients (0.6%), two of whom (0.2%) required pericardial drainage. Vascular complications occurred in 24 patients (2.4%), two of whom (0.2%) required vascular surgery. Phrenic nerve palsy occurred in 48 patients (4.8%) and persisted up to hospital discharge in six patients (0.6%). CONCLUSION: Pulmonary vein isolation procedures for paroxysmal or persistent AF using CBA can be performed at community hospitals with high acute efficacy and low complication rates.

The ABC of a Simple Method for Pulmonary Vein Angiography.

Catheter-directed intervention to treat atrial fibrillation (AF) is becoming widely accepted procedure in current clinical practice. For assessment of pulmonary vein (PV) anatomy, angiography of left atrium (LA) and/or PV is often performed. We present a new, simple angiographic method for PVs and LA opacification using SL1 sheath. Total of 100 patients in our clinic underwent this procedure. In all of the cases good angiographic results were achieved. No immediate or late complications related to this procedure were observed.

Improved success rate of cardiac resynchronization therapy implant by employing an active fixation coronary sinus lead.

AIMS: Cardiac resynchronization therapy (CRT) is the standard treatment for heart failure with severe reduced left ventricular (LV) function and wide QRS complex. Coronary sinus (CS) lead implantation is challenging and accompanied by substantial dislocation rates. We evaluated the usage of an active fixation LV lead (Attain Starfix, Medtronic, MN, USA) with deployable lobes in challenging lead positions. METHODS AND RESULTS: Between September 2006 and August 2009, 678 CRT devices were implanted. In 82 patients (12%) (59 male, 70 +/- 10 years, 39 ICM, 41 DCM, 2 valvular CM, LVEF 28 +/- 9%, NYHA 3.0 +/- 0.4, QRS 169 +/- 29 ms), the Attain Starfix active fixation lead was used. The main reason was intra-operative dislodgement of one (n = 47) or two (n = 5) passive fixation leads during implantation or revision procedure (n = 30). Active fixation lead implantation was overall successful with 90% (n = 74). Anatomical peculiarity was mostly an optimal lead position in otherwise unstable proximal parts of the target vein or a circumscripted areal of optimal threshold without phrenic nerve stimulation. At median follow-up of 99 days the threshold remained stable (1.2 +/- 0.8 vs. 1.0 +/- 0.5 V at 0.5 ms). Revisions due to instability in ectatic vein (n = 1) after 12 months and extractions (n = 2) because of device perforation/infection after 6/15 months were performed without complication. CONCLUSION: The Attain Starfix active fixation lead proved to be an important option in anatomically challenging, otherwise unstable positions often located in the proximal part of the target vein. Lead revisions or extractions as late as 15 months after implantation were feasible.

Atrioventricular node ablation is not a prerequisite for cardiac resynchronization therapy in patients with chronic atrial fibrillation.

BACKGROUND: In drug-refractory heart failure, cardiac resynchronization therapy (CRT) is an established method in patients with sinus rhythm, severe reduced ejection fraction and broad QRS. Heart failure is known as a predisposition for atrial fibrillation (AF). However, the putative impact of atrioventricular node (AVN) ablation in chronic AF and CRT remains unclear. The aim of this study was to elucidate the effects of CRT in patients with chronic AF and the requirement for AVN ablation. METHODS: A total of 100 patients were included in the retrospective study, 64 with sinus rhythm (SR) and 36 with chronic AF with a mean duration of 2.8 +/- 0.5 years. Clinical parameters, QRS duration and echocardiographic parameters were compared at baseline and after a follow-up of 11 +/- 0.34 months in patients with SR and in 27 patients with chronic AF who received optimized medication to control ventricular rate and nine patients who underwent an AVN ablation. RESULTS: Baseline characteristics between patients with SR or AF in the presence or absence of AVN ablation were comparable. In each group, a significant improvement of NYHA class, ejection fraction could be observed, with an analogous reduction of QRS duration and a diminished left ventricular end-diastolic dimension after 11 +/- 0.34 months of CRT. CONCLUSIONS: The present results demonstrate a comparable improvement in left ventricular function and functional capacity in all treated groups. In conclusion, AVN ablation is not a prerequisite for CRT in patients with severe heart failure and chronic AF.

A prospective randomized evaluation of VV delay optimization in CRT-D recipients: echocardiographic observations from the RHYTHM II ICD study.

BACKGROUND: All current cardiac resynchronization therapy (CRT) devices allow the programming of the atrioventricular (AV/PV) delays and the sequential stimulation of the ventricles via the inter ventricular (VV) delay. AIM: This post hoc analysis of the RHYTHM II study was conducted to compare the reverse remodeling associated with VV delay optimization in patients randomly assigned to simultaneous (SIM) biventricular stimulation versus patients assigned to optimized VV delay programming (OPT) (1:3 randomization scheme). METHODS: The analysis included 14 patients assigned to the SIM group and 34 patients to the OPT group who completed the 6-month follow-up period with paired echocardiographic recordings. RESULTS: In both study groups, changes consistent with left ventricular (LV) remodeling were observed between baseline and 6 months, with significant improvements in LV function and decrease in LV dimensions. In the OPT group, there was also a decrease in left atrial diameter and mitral valve closure to opening time. At 6 months, the overall proportion of echocardiographic responders (> or =10% decrease in LV end-systolic volume or > or =5% absolute increase in LV ejection fraction) was similar in both groups. The optimal AV/VV delays, evaluated by maximization of LV outflow tract velocity time integral, changed over time. CONCLUSIONS: Ventriculo-ventricular delay optimization was associated with better immediate hemodynamic function than simultaneous biventricular stimulation, though did not promote additional reverse remodeling at 6 months and did not increase the proportion of echocardiographic responders to CRT. Optimization of both the AV and VV intervals was patient-specific and optimal values changed over time.

Different venous angioplasty manoeuvres for successful implantation of CRT devices.

AIMS: Cardiac resynchronization therapy (CRT) has growing impact in the treatment of severe heart failure Stenosis of coronary veins, complex structure of coronary sinus and occlusions of subclavian veins can limit lead passage in the target vein. METHODS AND RESULTS: Retrospective analysis of 705 implantation procedures of CRT devices from 1999 to July 2007 in a single centre to show the impact of venous angioplasty manoeuvres for successful placement of left ventricular lead. In 31 patients (3.5%) venous angioplasty was performed for LV-lead placement: 24 coronary veins (balloons 2.5-4.0 mm), 4 subclavian veins, 3 valves in the coronary sinus and one Marshall vein were dilated. Ring like strictures of coronary veins made high inflation pressures (16 +/- 4 atm) necessary. Success rate of LV lead placement were 99%. Complications were rare. CONCLUSIONS: Angioplasty of coronary or subclavian veins and valve structures of coronary sinus are a useful and safe tool for successful lead placement. The use of balloons of 3.0mm in size usually allows implantation of at least a unipolar lead.

Randomized comparison of simultaneous biventricular stimulation versus optimized interventricular delay in cardiac resynchronization therapy. The Resynchronization for the HemodYnamic Treatment for Heart Failure Management II implantable cardioverter defibrillator (RHYTHM II ICD) study.

BACKGROUND: The clinical value of interventricular (V-V) delay optimization in patients with chronic congestive heart failure (CHF) undergoing implantation of a device for cardiac resynchronization therapy (CRT) has not been clearly demonstrated. METHODS: RHYTHM II was a single-blind randomized trial including 121 recipients of a device for CRT with cardioverter/defibrillator capabilities (CRT-D) randomly assigned in a 1:3 ratio to simultaneous (n = 30) versus optimized (OPT) (n = 91) biventricular pacing. V-V delay was optimized by echocardiography. The study end points were (1) freedom from CRT-D system-related complications and (2) changes between preimplant and 6 months of follow-up in (a) New York Heart Association CHF functional class, (b) distance covered during a 6-minute hall walk, and (c) quality of life (QOL). RESULTS: In the OPT group, the V-V delay ranged from 0 to 80 milliseconds, with 28.4% of patients stimulated at an OPT V-V delay of 0 milliseconds. The overall 6-month survival free of adverse events requiring invasive interventions was 81.8%. In the whole cohort, 6 months of CRT-D was associated with a significant decrease in New York Heart Association class, increase in the distance covered during the 6-minute hall walk, and improvement in QOL (each P < .0001). The effects of CRT-D on these end points were similar in both study groups. CONCLUSIONS: Cardioverter-defibrillator capabilities was associated with a significant alleviation of CHF symptoms, increase in functional capacity, and improvement in QOL. The optimization of the V-V delay conferred no additional benefit compared with simultaneous biventricular stimulation.