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).

How-to: Focus Cardiac Ultrasound in acute settings.

Focus cardiac ultrasound (FoCUS) provides vital information at at the bedside which has the potential of improving outcomes in the acute settings. FoCUS could help the clinicians in their daily clinical decision-making while applied within the clinical context as an extension of bedside clinical examination. FoCUS practitioners should be aware of their own limitations with the importance of the timely referral for comprehensive Echocardiography whenever required.

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.

Level 1 of Entrustable Professional Activities in adult echocardiography: a position statement from the EACVI regarding the training and competence requirements for selecting and interpreting echocardiographic examinations.

The goal of Level 1 training in echocardiography is to enable the trainee to select echocardiography appropriately for the evaluation of a specific clinical question, and then to interpret the report. It is not the goal of Level 1 training to teach how to perform the examination itself-that is the goal of higher levels of training. However, understanding the principles, indications, and findings of this crucial technique is valuable to many medical professionals including outside cardiology. This should be seen as part of a general understanding of cardiac imaging modalities. The purpose of this position statement is to define the scope and outline the general requirements for Level 1 training and competence in echocardiography. Moreover, the document aims to make a clear distinction between Level 1 competence in echocardiography and focus cardiac ultrasound (FoCUS).

Outcome in patients undergoing upgrade to cardiac resynchronization therapy: predictors of outcome after upgrade to CRT.

The advantages of upgrade to cardiac resynchronisation therapy (CRT) have not been explored as carefully as the outcomes of de novo CRT implantations. Furthermore selection criteria for patients with the potential to benefit the most from this therapy are unknown. Therefore, we analyzed the long term outcome and its predictors in a real-world cohort receiving a CRT upgrade from previous pacemaker (PM) and defibrillator devices (ICD). We analyzed 86 patients (mean age 68 ± 9 years; 89% male) undergoing CRT upgrade procedures. Response to CRT as well as long term patient outcome was analyzed. NYHA class improved in majority of the patients during short term period (61%), and this trend remained constant during long term follow-up (54%). The observed all-cause mortality was 54% with mean survival of 49 ± 4 months. 11 patients underwent left ventricular assist device implantation or heart transplantation. In the multivariate analysis, only kidney function assessed by GFR (HR 0.97; 95% CI 0.95-0.99; p = 0.009) and LVEF (HR 0.92; 95% CI 0.87-0.97; p = 0.002) remain predictors for mortality. Patients who undergo an upgrade procedure to CRT demonstrate a significant response rate assessed by improvement in NYHA class, with initial baseline parameters such as LVEF and kidney function remaining significant predictors for mortality.

Characterizing left ventricular mechanical and electrical activation in patients with normal and impaired systolic function using a non-fluoroscopic cardiovascular navigation system.

PURPOSE: Cardiac disease frequently has a degenerative effect on cardiac pump function and regional myocardial contraction. Therefore, an accurate assessment of regional wall motion is a measure of the extent and severity of the disease. We sought to further validate an intra-operative, sensor-based technology for measuring wall motion and strain by characterizing left ventricular (LV) mechanical and electrical activation patterns in patients with normal (NSF) and impaired systolic function (ISF). METHODS: NSF (n = 10; ejection fraction = 62.9 ± 6.1%) and ISF (n = 18; ejection fraction = 35.1 ± 13.6%) patients underwent simultaneous electrical and motion mapping of the LV endocardium using electroanatomical mapping and navigational systems (EnSite™ NavX™ and MediGuide™, Abbott). Motion trajectories, strain profiles, and activation times were calculated over the six standard LV walls. RESULTS: NSF patients had significantly greater motion and systolic strains across all LV walls than ISF patients. LV walls with low-voltage areas showed less motion and systolic strain than walls with normal voltage. LV electrical dyssynchrony was significantly smaller in NSF and ISF patients with narrow-QRS complexes than ISF patients with wide-QRS complexes, but mechanical dyssynchrony was larger in all ISF patients than NSF patients. The latest mechanical activation was most often the lateral/posterior walls in NSF and wide-QRS ISF patients but varied in narrow-QRS ISF patients. CONCLUSIONS: This intra-operative technique can be used to characterize LV wall motion and strain in patients with impaired systolic function. This technique may be utilized clinically to provide individually tailored LV lead positioning at the region of latest mechanical activation for patients undergoing cardiac resynchronization therapy. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01629160.

Individually tailored vs. standardized substrate modification during radiofrequency catheter ablation for atrial fibrillation: a randomized study.

Aims: This randomized single-centre study sought to compare the efficacy and safety of pulmonary vein isolation (PVI) plus voltage-guided ablation vs. PVI with or without linear ablation depending on the type of atrial fibrillation (AF). Methods and results: Overall, 124 ablation-naive patients with paroxysmal or persistent AF were randomized to PVI with (persistent AF) or without (paroxysmal AF) additional linear ablation (control group) vs. PVI plus ablation of low-voltage areas (LVAs) irrespective of AF type. Bipolar voltage mapping was performed during stable sinus rhythm. An LVA consisted of ≥ 3 adjacent mapping points that each had a peak-to-peak amplitude ≤0.5 mV. After a mean follow-up of 12 ± 3 months, significantly more patients in the LVA ablation group were free from atrial arrhythmia recurrence >30 s off antiarrhythmic drugs (AADs) after a single procedure (primary endpoint) compared with control group patients [40/59 (68%) vs. 25/59 (42%), log-rank P = 0.003]. Arrhythmia-free survival on or off AADs was found in 33/59 control group patients (56%) and in 41/59 LVA ablation group patients (70%) (adjusted log-rank P = 0.10). During the 7 day Holter monitoring period at 12 months, significantly more patients in the LVA ablation group were free from arrhythmia recurrence on or off AADs [45/50 (90%) vs. 33/46 (72%), P = 0.04]. No between-group differences were observed regarding procedure duration, fluoroscopy time, and major complications. Conclusion: In this single-centre study, individually tailored substrate modification guided by voltage mapping was associated with a significantly higher arrhythmia-free survival rate compared with a conventional approach applying linear ablation according to AF type.

[Malignant bileaflet mitral valve prolapse syndrome in otherwise idiopathic ventricular fibrillation]. / Malignes Mitralklappenprolapssyndrom bei "idiopathischem" Kammerflimmern.

A 32-year-old, otherwise healthy woman was admitted after successful out-of-hospital resuscitation due to ventricular fibrillation. Established cardiac, pulmonary, metabolic, and toxicological causes were excluded. However, persisting (biphasic) negative T waves in the inferior ECG leads and premature ventricular contractions (PVC) were noted. PVC morphology indicated a focus alternating between the posterior papillary muscle/the left posterior fascicle and the left ventricular outflow tract region/anterior papillary muscle. Echocardiography revealed a bileaflet mitral prolapse with mild mitral valve regurgitation. This case is a typical presentation of the recently described malignant bileaflet mitral valve prolapse syndrome. The patient was discharged without overt neurological deficit after implantation of a cardioverter-defibrillator.

Mapping-guided characterization of mechanical and electrical activation patterns in patients with normal systolic function using a sensor-based tracking technology.

AIMS: In times of evolving cardiac resynchronization therapy, intra-procedural characterization of left ventricular (LV) mechanical activation patterns is desired but technically challenging with currently available technologies. In patients with normal systolic function, we evaluated the feasibility of characterizing LV wall motion using a novel sensor-based, real-time tracking technology. METHODS AND RESULTS: Ten patients underwent simultaneous motion and electrical mapping of the LV endocardium during sinus rhythm using electroanatomical mapping and navigational systems (EnSite™ NavX™ and MediGuide™, SJM). Epicardial motion data were also collected simultaneously at corresponding locations from accessible coronary sinus branches. Displacements at each mapping point and times of electrical and mechanical activation were combined over each of the six standard LV wall segments. Mechanical activation timing was compared with that from electrical activation and preoperative 2D speckle tracking echocardiography (echo). MediGuide-based displacement data were further analysed to estimate LV chamber volumes that were compared with echo and magnetic resonance imaging (MRI). The lateral and septal walls exhibited the largest (12.5 [11.6-15.0] mm) and smallest (10.2 [9.0-11.3] mm) displacement, respectively. Radial displacement was significantly larger endocardially than epicardially (endo: 6.7 [5.0-9.1] mm; epi: 3.8 [2.4-5.6] mm), while longitudinal displacement was significantly larger epicardially (endo: 8.0 [5.0-10.6] mm; epi: 10.3 [7.4-13.8] mm). Most often, the anteroseptal/anterior and lateral walls showed the earliest and latest mechanical activations, respectively. 9/10 patients had concordant or adjacent wall segments of latest mechanical and electrical activation, and 6/10 patients had concordant or adjacent wall segments of latest mechanical activation as measured by MediGuide and echo. MediGuide's LV chamber volumes were significantly correlated with MRI (R2= 0.73, P < 0.01) and echo (R2= 0.75, P < 0.001). CONCLUSION: The feasibility of mapping-guided intra-procedural characterization of LV wall motion was established. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov; Unique identifier: CT01629160.

Association between ventricular arrhythmias and myocardial mechanical dispersion assessed by strain analysis in patients with nonischemic cardiomyopathy.

BACKGROUND: Mechanical dispersion (MD), defined as the standard deviation of time to maximum myocardial shortening assessed by 2D speckle tracking echocardiographic strain imaging (2DS), has been recently proposed as a predictor for ventricular tachycardia or fibrillation (VT/VF) in patients with ischemic cardiomyopathy and long QT syndrome. However, the role of MD in patients with non-ischemic cardiomyopathy (NICM) has not yet been studied. METHODS AND RESULTS: In 20 patients with NICM (mean age 62 ± 11 years, 75 % male, mean EF 32 ± 6 %, mean QRS duration 102 ± 14 ms), we measured longitudinal strain by 2DS in a 16-segment left ventricular model and calculated the MD. Patients were divided into two groups, defined by the presence or absence of documented VT/VF. In 11 patients (55 %), VT/VF was documented. The median time from VT/VF to echocardiographic examination was 26 (IQR 15-58) months. There were no significant differences in baseline characteristics between patients with and without index events. MD was significantly greater in patients with VT/VF as compared to those without arrhythmias (84 ± 31 ms vs. 53 ± 16 ms, p = 0.017). The analysis of the ROC curve (AUC 0.81, 95 % CI 0.63-1.00, p = 0.017) revealed that dispersion >50 ms is associated with twelve times higher risk of VT/VF in patients with NICM (OR 12.5, 95 % CI 1.1-143.4, p = 0.024). CONCLUSIONS: In this small cohort of NICM patients, greater MD was associated with a higher incidence of VT/VF.

Irrigated tip catheters for radiofrequency ablation in ventricular tachycardia.

Radiofrequency (RF) ablation with irrigated tip catheters decreases the likelihood of thrombus and char formation and enables the creation of larger lesions. Due to the potential dramatic consequences, the prevention of thromboembolic events is of particular importance for left-sided procedures. Although acute success rates of ventricular tachycardia (VT) ablation are satisfactory, recurrence rate is high. Apart from the progress of the underlying disease, reconduction and the lack of effective transmural lesions play a major role for VT recurrences. This paper reviews principles of lesion formation with radiofrequency and the effect of tip irrigation as well as recent advances in new technology. Potential areas of further development of catheter technology might be the improvement of mapping by better substrate definition and resolution, the introduction of bipolar and multipolar ablation techniques into clinical routine, and the use of alternative sources of energy.

Precordial QRS amplitude ratio predicts long-term outcome after catheter ablation of electrical storm due to ventricular tachycardias in patients with arrhythmogenic right ventricular cardiomyopathy.

BACKGROUND: Radiofrequency catheter ablation is currently considered as the therapeutic option of choice in patients with arrhythmogenic right ventricular cardiomyopathy (ARVC) and recurrent ventricular tachycardia (VT). METHODS: This study intended to assess the long-term outcome of catheter ablation in patients with ARVC and electrical storm. The specific objective was to assess the relationship between precordial QRS amplitude ratio and outcome of catheter ablation in these patients. RESULTS: Twenty-eight patients (19 men, age 52.3±14.2years) underwent 48 catheter ablation procedures (range 1-6, six epicardial). During a mean follow-up of 18.7±15.1months, 13 patients (46.5%) experienced VT recurrence. Age >50years and ∑QRSmvV1-V3/∑QRSmvV1-V6≤0.48 but not right ventricular size and acute ablation outcome were associated with VT recurrence during the follow up. CONCLUSION: Age >50years and ∑QRSmvV1-V3/∑QRSmvV1-V6≤0.48 predict recurrence of VT after successful radiofrequency catheter ablation of VT in patients with ARVC and electrical storm.

Sensor-based electromagnetic navigation to facilitate implantation of left ventricular leads in cardiac resynchronization therapy.

INTRODUCTION: Implantation of cardiac resynchronization therapy (CRT) devices can be challenging, time consuming, and fluoroscopy intense. To facilitate placement of left ventricular (LV) leads, a novel electromagnetic navigation system (MediGuide™, St. Jude Medical, St. Paul, MN, USA) has been developed, displaying real-time 3-D location of sensor-embedded delivery tools superimposed on prerecorded X-ray cine-loops of coronary sinus venograms. We report our experience and advanced progress in the use of this new electromagnetic tracking system to guide LV lead implantation. METHODS AND RESULTS: Between January 2012 and December 2013, 71 consecutive patients (69 ± 9 years, 76% male) were implanted with a CRT device using the new electromagnetic tracking system. Demographics, procedural data, and periprocedural adverse events were gathered. The impact of the operator's experience, optimized workflow, and improved software technology on procedural data were analyzed. LV lead implantation was successfully achieved in all patients without severe adverse events. Total procedure time measured 87 ± 37 minutes and the median total fluoroscopy time (skin-to-skin) was 4.9 (2.5-7.8) minutes with a median dose-area-product of 476 (260-1056) cGy*cm(2) . An additional comparison with conventional CRT device implantations showed a significant reduction in fluoroscopy time from 8.0 (5.8; 11.5) to 4.5 (2.8; 7.3) minutes (P = 0.016) and radiation dose from 603 (330; 969) to 338 (176; 680) cGy*cm(2) , respectively (P = 0.044 ). CONCLUSION: Use of the new navigation system enables safe and successful LV lead placement with improved orientation and significantly reduced radiation exposure during CRT implantation.

Patient discomfort following catheter ablation and rhythm device surgery.

AIMS: Proper management of post-interventional pain relieves unwarranted patient distress and enhances patient satisfaction. There have been only a limited number of investigations into patient discomfort following electrophysiological interventions. This study aims to quantify pain after interventional procedures, including ablation of atrial fibrillation (AF) or ventricular tachycardia (VT), as well as implant or explant of pacemakers or implantable cardioverter defibrillators. METHODS AND RESULTS: One-hundred and two consecutive patients (mean age 66 years, 70 men) were asked to quantify post-interventional pain on a numeric rating scale (NRS 0-10) every 2 h during a period of 24 h after their intervention (49 ablations in deep propofol sedation, 53 device surgeries in local anaesthesia with mepivacaine 1%) and to specify the type of pain. Pain was classified as moderate to severe in case of NRS > 3. Post-operative pain medication included non-opioid and opioid analgesics as per the treating physicians' discretion. Sixty-one patients (60%) suffered from moderate-to-severe pain within the first 24 h after the procedure, despite the use of analgesics in 47 patients (46%). Pain was present in an early period (0-6 h) in 54% and in a late period (8-24 h) in 40% of patients. Patients complained of back pain (44%), pain at the site of the device pocket (39%), pain at the groin after puncture (7%), and pericarditic pain (5%). Multivariate analysis identified female gender (P = 0.046) associated with early post-interventional pain while age, diabetes mellitus, body mass index, type of intervention, and procedure time were not related to early or late post-interventional pain. CONCLUSION: The findings highlight the high prevalence and the poor predictability of moderate-to-severe post-interventional pain within the first 24 h after catheter ablation and cardiac device surgery procedures, despite the use of peri-interventional analgesics. These findings highlight the need for more careful pain assessment and management programmes.

Comparison of dabigatran and uninterrupted warfarin in patients with atrial fibrillation undergoing cardiac rhythm device implantations. Case-control study.

BACKGROUND: The incidence of postoperative complications following pacemaker or implantable cardioverter-defibrillator implantations in patients treated with new oral anticoagulation agents has not been studied. Here we present a first comparison of complications after cardiac rhythm device (CRD) implantations in patients with atrial fibrillation (AF) treated with dabigatran or uninterrupted warfarin. METHODS AND RESULTS: Using a case-control study design, we compared complications within 30 days after 236 CRD procedures performed under uninterrupted warfarin (n=118) or interrupted dabigatran (n=118).There were no significant differences in the baseline characteristics of both groups. In the warfarin group, 9 (8%) pocket hematomas were observed vs. 3 (3%) in the dabigatran group (P=0.075). Two complications in the warfarin group necessitated surgical intervention as opposed to none in the dabigatran group (P=0.156). The postprocedural blood loss expressed as a drop in hemoglobin was significantly greater in the warfarin group (-0.9±0.7 vs. -0.5±0.4 mmol/L, P=0.023). In the dabigatran group, 1 case of transient ischemic attack occurred. The mean time to hospital discharge was shorter in patients treated with dabigatran (2.5±2.3 vs. 3.8±4.1 days, P=0.02). CONCLUSIONS: The incidence and severity of bleeding complications may be lower in patients treated with periprocedurally discontinued dabigatran when compared with uninterrupted warfarin therapy. Further evaluation of peri-interventional complications and establishment of an optimal anticoagulation management protocol are needed.

Comparison of Dabigatran and Uninterrupted Warfarin in Patients With Atrial Fibrillation Undergoing Cardiac Rhythm Device Implantations.

Background:The incidence of postoperative complications following pacemaker or implantable cardioverter-defibrillator implantations in patients treated with new oral anticoagulation agents has not been studied. Here we present a first comparison of complications after cardiac rhythm device (CRD) implantations in patients with atrial fibrillation (AF) treated with dabigatran or uninterrupted warfarin.Methods and Results:Using a case-control study design, we compared complications within 30 days after 236 CRD procedures performed under uninterrupted warfarin (n=118) or interrupted dabigatran (n=118).There were no significant differences in the baseline characteristics of both groups. In the warfarin group, 9 (8%) pocket hematomas were observed vs. 3 (3%) in the dabigatran group (P=0.075). Two complications in the warfarin group necessitated surgical intervention as opposed to none in the dabigatran group (P=0.156). The postprocedural blood loss expressed as a drop in hemoglobin was significantly greater in the warfarin group (-0.9±0.7 vs. -0.5±0.4 mmol/L, P=0.023). In the dabigatran group, 1 case of transient ischemic attack occurred. The mean time to hospital discharge was shorter in patients treated with dabigatran (2.5±2.3 vs. 3.8±4.1 days, P=0.02).Conclusions:The incidence and severity of bleeding complications may be lower in patients treated with periprocedurally discontinued dabigatran when compared with uninterrupted warfarin therapy. Further evaluation of peri-interventional complications and establishment of an optimal anticoagulation management protocol are needed.