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.

Quantification of tricuspid regurgitation area by 3-dimensional color Doppler echocardiography considering different clinical settings.

PURPOSE: The precise assessment of tricuspid regurgitation (TR) using 2D imaging techniques may be associated with significant difficulties due to the nonround regurgitation area. Direct analysis of the regurgitation area by 3D color Doppler echocardiography at the vena contracta (3D VCA) has the potential to adequately quantify even complex TR. This study compared 3D VCA for quantification of the TR with the regurgitant area determined by proximal isovolumetric convergence method (PISA-EROA) considering different clinical settings. METHODS: In 95 patients with TR of different severity, the regurgitant orifice area was determined by 3D color Doppler echocardiography and by PISA-EROA. Using 3D color Doppler echocardiography, the regurgitant orifice area was determined three times in each patient considering 3 datasets. RESULTS: Mean 3D VCA was 0.27 ± 0.14, 0.27 ± 0.13, and 0.29 ± 0.14 cm2 , respectively, as determined by three separate measurements in each of the 95 patients. There was a mean relative deviation between the three measurements in each patient of 12.4 ± 14.9%. The regurgitant orifice area using the PISA method was 0.28 ± 0.14 cm2 . There was a mean difference of 0.07 cm2 (95% CI -0.124 to 0.138 cm2 ) between 3D VCA and PISA-EROA. The correlation between 3D VCA and PISA-EROA was r = .88 (P < .001). Considering a grading of TR severity in grade I (regurgitant area < 0.2 cm2 ), grade II (area 0.2-0.4 cm2 ), and grade III (area > 0.4 cm2 ), there was a good agreement between severity grade determined by 3D VCA and severity grade determined by PISA-EROA (kappa 0.71). CONCLUSION: The analysis of the VCA of a TR using 3D color Doppler echocardiography is an alternative method to determine the regurgitant severity with good agreement to the PISA method.

Clinical safety of the ProMRI implantable cardioverter-defibrillator systems during head and lower lumbar magnetic resonance imaging at 3 T: results of the ProMRI 3T ENHANCED Master study.

AIMS: There have been no published studies on the safety of magnetic resonance imaging (MRI) at 3 Tesla (3 T) in patients with MRI-conditional implantable cardioverter-defibrillators (ICDs). The aim of this study was to assess clinical safety of the Biotronik ProMRI ICD system during non-diagnostic head and lower lumbar scans under 3 T MRI conditions. METHODS AND RESULTS: The study enrolled 129 patients at 12 sites in Australia, Singapore, and Europe. Predefined head and lower lumbar MR scans (total duration ≈30 min) were performed in 112 patients. Three primary endpoints were evaluated from the pre-MRI to the 1-month post-MRI visit: (i) freedom from serious adverse device effects (SADEs) related to MRI (hypothesized to be >90%); (ii) pacing threshold invariance for all leads (geometric mean of the patient-wise ratios for 1 month vs. pre-MRI was hypothesized to be <1.07); and (iii) sensing amplitude invariance (geometric mean of the ratios was hypothesized to be >0.993). No MRI-related SADE occurred (SADE-free rate 100%, 95% confidence interval 95.98-100%). Pacing threshold and sensing amplitudes fulfilled the invariance hypotheses with high statistical significance (P < 0.0013). No threshold increase >0.5 V or sensing amplitude decrease by >50% was observed (secondary endpoints). Lead impedances, battery capacity, and detection and treatment of arrhythmias by ICDs were not affected by MRI scans. CONCLUSION: The head and lower lumbar scans under specific 3 T MRI conditions were safe in the investigated MR-conditional ICD systems. There was no evidence of harm to the patients or any negative influence of the MRI scan on the implanted systems.

Image noise reduction technology allows significant reduction of radiation dosage in cardiac device implantation procedures.

BACKGROUND: Novel x-ray systems with real-time image noise reduction technology (INRT) to reduce radiation dose during fluoroscopy and cine acquisition have become available. This study evaluated the reduction of radiation dose in device implantation with INRT. METHODS: Radiation dose data from 132 consecutive new device implantation procedures (102 pacemaker [PM] or implantable cardioverter defibrillator [ICD] and 30 cardiac resynchronization therapy [CRT] devices) performed between January 2015 and December 2015 on an angiography system with INRT (Allura ClarityIQ) were collected. For comparison, radiation dose data from 147 consecutive device implantation procedures (121 PM/ICDs and 26 CRT devices) performed between June 2013 and September 2014 on a C-arm system with continuous and pulsed fluoroscopy option (4 frames/second) were evaluated. Total dose area product (DAP), fluoroscopy DAP, and cine DAP were evaluated. RESULTS: Patient age, gender and body weight, procedure, and fluoroscopy times were similar between systems. In PM/ICD cases, DAP of INRT and C-arm system was similar (423 ± 381 cGycm2  vs 417 ± 517 cGycm) due to pulsed fluoroscopy with the C-arm system (78% of time) and sparse use of cine. In CRT procedures requiring higher image quality (82% use of continuous fluoroscopy with C-arm system), DAP of INRT was significantly lower (1,544 ± 834 cGycm vs 7,252 ± 6,431 cGycm, P < 0.001) due to less fluoroscopy DAP (1,414 ± 757 cGycm vs 5,854 ± 6,767 cGycm) and less cine DAP (130 ± 106 cGycm vs 1,399 ± 1,342 cGycm). Considering all procedures, total DAP was reduced by 60% using INRT. CONCLUSION: Novel INRT results in a substantial lowering of radiation dose in device implantation, in particular, in complex CRT implantation procedures requiring high image quality.

Reducing Radiation Dose in Coronary Angiography and Angioplasty Using Image Noise Reduction Technology.

This study sought to quantitatively evaluate the reduction of radiation dose in coronary angiography and angioplasty with the use of image noise reduction technology in a routine clinical setting. Radiation dose data from consecutive 605 coronary procedures (397 consecutive coronary angiograms and 208 consecutive coronary interventions) performed from October 2014 to April 2015 on a coronary angiography system with noise reduction technology (Allura Clarity IQ) were collected. For comparison, radiation dose data from consecutive 695 coronary procedures (435 coronary angiograms and 260 coronary interventions) performed on a conventional coronary angiography system from October 2013 to April 2014 were evaluated. Patient radiation dosage was evaluated based on the cumulative dose area product. Operators and operator practice did not change between the 2 evaluated periods. Patient characteristics were collected to evaluate similarity of patient groups. Image quality was evaluated on a 5-grade scale in 30 patients of each group. There were no significant differences between the 2 evaluated groups in gender, age, weight, and fluoroscopy time (6.8 ± 6.1 vs 6.9 ± 6.3 minutes, not significant). The dose area product was reduced from 3195 ± 2359 to 983 ± 972 cGycm(2) (65%, p <0.001) in coronary angiograms and from 7123 ± 4551 to 2431 ± 1788 cGycm(2) (69%, p <0.001) in coronary interventions using the new noise reduction technology. Image quality was graded as similar between the evaluated systems (4.0 ± 0.7 vs 4.2 ± 0.6, not significant). In conclusion, a new x-ray technology with image noise reduction algorithm provides a substantial reduction in radiation exposure without the need to prolong the procedure or fluoroscopy time.

Long-term deep brain stimulation in elderly patients with cardiac pacemakers.

OBJECT: Deep brain stimulation (DBS) has become an accepted therapy for movement disorders such as Parkinson disease (PD) and essential tremor (ET), when these conditions are refractory to medical treatment. The presence of a cardiac pacemaker is still considered a contraindication for DBS in functional neurosurgery. The goal of this study was to evaluate the technical and clinical management of DBS for the treatment of movement disorders in elderly patients with cardiac pacemakers. METHODS: Six patients with cardiac pacemakers underwent clinical and cardiac examinations to analyze the safety of DBS in the treatment of movement disorders. Four patients suffered from advanced PD and two patients had ET. The mean age of these patients at surgery was 69.5 years (range 63-79 years). The settings of the pacemakers were programmed in a manner considered to minimize the chance of interference between the two systems. There were no adverse events during surgery. Four patients underwent stimulation of the thalamic ventralis intermedius nucleus (VIM), and two patients stimulation of the subthalamic nucleus. In general, bipolar sensing was chosen for the cardiac pacemakers. In all but one patient the quadripolar DBS electrodes were programmed for bipolar stimulation. Several control electrocardiography studies, including 24-hour monitoring, did not show any interference between the two systems. At the time this paper was written the patients had been followed up for a mean of 25.3 months (range 4-48 months). CONCLUSIONS: In certain conditions it is safe for patients with cardiac pacemakers to receive DBS for treatment of concomitant movement disorders. Cardiac pacemakers should not be viewed as a general contraindication for DBS in patients with movement disorders.

Are electrophysiological studies needed prior to defibrillator implantation?

At present, patients with documented sustained VT or resuscitated cardiac arrest (CA) are treated with ICDs. The aim of this study was to retrospectively evaluate if a routine electrophysiological study should be recommended prior to ICD implantation. In 462 patients referred for ICD implantation because of supposedly documented VT (n = 223) or CA (n = 239), electrophysiological study was routinely performed. In 48% of the patients with CA, sustained VT or VF was inducible. Electrophysiological study suggested conduction abnormalities (n = 11) or supraventricular tachyarrhythmias (n = 3) in conjunction with severely impaired left ventricular function to have been the most likely cause of CA in 14 (5.9%) of 239 patients. Likewise, sustained VT was only inducible in 48% of patients with supposedly documented VT. Of these inducible VTs, nine were diagnosed as right ventricular outflow tract tachycardia or as bundle branch reentry tachycardia. Supraventricular tachyarrhythmias judged to represent the clinical event were the only inducible arrhythmia in 35 (16%) patients (AV nodal reentrant tachycardia [n = 7], AV reentry tachycardia [n = 4], atrial flutter [n = 19], and atrial tachycardia [n = 5]). Based on findings from the electrophysiological study, ICD implantation was withheld in 14 (5.9%) of 239 patients with CA and in 44 (19.7%) of 223 patients with supposedly documented VT. During electrophysiological study, VT or VF was only reproducible in about 50% of patients with supposedly documented VT or CA. Electrophysiological study revealed other, potentially curable causes for CA or supposedly documented VT in 12.6% (58/462) of all patients, indicating that ICD implantation can potentially be avoided or at least postponed in some of these patients. Based on these retrospective data, routine electrophysiological study prior to ICD implantation seems to be advisable.

Ventricular oversensing: a study of 101 patients implanted with dual chamber defibrillators and two different lead systems.

UNLABELLED: Modern dual chamber ICD systems are able to overcome various sensing problems. However, improvement of their performance is still required. The aim of this study was to assess the sensing function in 101 consecutive patients (84 men, 17 women; mean age 63 +/- 12 years; mean follow-up 24 +/- 4 months) implanted with dual chamber defibrillators and integrated (IB) or dedicated bipolar (DB) lead systems. Follow-up data were analyzed for the presence of ventricular oversensing. Oversensing occurred in 25 (25%) patients, significantly more frequent in patients implanted with IB compared to DB lead systems (21/52 vs 4/49, P = 0.0002). Patients with cardiomyopathies (CMs) were more prone to sensing malfunctions than patients with no CM (12/30 vs 13/71, P = 0.04). T wave oversensing (n = 14), respirophasic ventricular oversensing (n = 4), and P wave oversensing (n = 6) were the most common pitfalls of ventricular sensing. P wave oversensing was unique to the IB lead system. CT scans performed in these patients disclosed the position of the RV coil to be proximal to the tricuspid area. Four patients received inappropriate ICD shocks due to oversensing. In all but two patients who received lead revision, oversensing was resolved by noninvasive means. IN CONCLUSION: (1) ventricular oversensing is a common problem occurring in up to 25% of patients with dual chamber ICDs; (2) P wave oversensing is a ventricular sensing problem affecting function of 11% of dual chamber devices with IB lead systems; (3) IB leads are significantly more susceptible to T wave and P wave oversensing than DB leads; and (4) patients with cardiomyopathies are more prone to oversensing than patients with other heart diseases.