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 stabilizing potential of anterior, posterior and combined techniques for the reconstruction of a 2-level cervical corpectomy model: biomechanical study and first results of ATPS prototyping.

Clinical studies reported frequent failure with anterior instrumented multilevel cervical corpectomies. Hence, posterior augmentation was recommended but necessitates a second approach. Thus, an author group evaluated the feasibility, pull-out characteristics, and accuracy of anterior transpedicular screw (ATPS) fixation. Although first success with clinical application of ATPS has already been reported, no data exist on biomechanical characteristics of an ATPS-plate system enabling transpedicular end-level fixation in advanced instabilities. Therefore, we evaluated biomechanical qualities of an ATPS prototype C4-C7 for reduction of range of motion (ROM) and primary stability in a non-destructive setup among five constructs: anterior plate, posterior all-lateral mass screw construct, posterior construct with lateral mass screws C5 + C6 and end-level fixation using pedicle screws unilaterally or bilaterally, and a 360° construct. 12 human spines C3-T1 were divided into two groups. Four constructs were tested in group 1 and three in group 2; the ATPS prototypes were tested in both groups. Specimens were subjected to flexibility test in a spine motion tester at intact state and after 2-level corpectomy C5-C6 with subsequent reconstruction using a distractable cage and one of the osteosynthesis mentioned above. ROM in flexion-extension, axial rotation, and lateral bending was reported as normalized values. All instrumentations but the anterior plate showed significant reduction of ROM for all directions compared to the intact state. The 360° construct outperformed all others in terms of reducing ROM. While there were no significant differences between the 360° and posterior constructs in flexion-extension and lateral bending, the 360° constructs were significantly more stable in axial rotation. Concerning primary stability of ATPS prototypes, there were no significant differences compared to posterior-only constructs in flexion-extension and axial rotation. The 360° construct showed significant differences to the ATPS prototypes in flexion-extension, while no significant differences existed in axial rotation. But in lateral bending, the ATPS prototype and the anterior plate performed significantly worse than the posterior constructs. ATPS was shown to confer increased primary stability compared to the anterior plate in flexion-extension and axial rotation with the latter yielding significance. We showed that primary stability after 2-level corpectomy reconstruction using ATPS prototypes compared favorably to posterior systems and superior to anterior plates. From the biomechanical point, the 360° instrumentation was shown the most efficient for reconstruction of 2-level corpectomies. Further studies will elucidate whether fatigue testing will enhance the benefit of transpedicular anchorage with posterior constructs and ATPS.