Reconnection patterns after CLOSE-guided 50 W high-power-short-duration circumferential pulmonary vein isolation and substrate modification-PV reconnection might no longer be an issue.

INTRODUCTION: Ablation of atrial fibrillation (AF) with high-power-short-duration (HPSD) radiofrequency (RF) technology is emerging as a new standard of care in many electrophysiology laboratories. While procedural short-term efficacy and efficiency is very promising, little is known about mid- to long-term effects of HPSD ablation for pulmonary vein isolation (PVI) and left atrial substrate modification. METHODS: In a single-center registry, 412 AF procedures were performed in 400 individual patients using a standardized CLOSE protocol-guided fixed 50 W HPSD ablation, aiming for an ablation index (AI) of 400 on the posterior and 550 on the anterior wall. Additional substrate-tailored lines were performed when required. RESULTS: After a mean clinical follow-up of 337 ± 134 days, 15 patients suffered from AF recurrence beyond the blinding period. Twelve gave consent to the indicated reablation. Here, 11 of 12 patients had chronic isolation of all four pulmonary veins (PV). In three of six patients, a reconnection of additional left atrial ablation lines was revealed. Ten out of 12 patients showed progressive fibrous atrial cardiomyopathy and required additional left atrial substrate modification or reisolation of left-atrial lines. During the follow-up no clinical case of atrioesophageal fistula was registered. No PV stenosis after initial HPSD PVI was documented. CONCLUSIONS: Patients requiring reablation of AF or other atrial tachycardia after a fixed 50 W HPSD circumferential PVI and substrate modification predominantly suffer from progressive fibrous atrial cardiomyopathy, while PV reconnection appears to be a rare cause of AF recurrence.

Esophageal safety in CLOSE-guided 50 W high-power-short-duration pulmonary vein isolation: The PREHEAT-PVI-registry.

INTRODUCTION: Pulmonary vein isolation (PVI) using high-power-short-duration (HPSD) radiofrequency ablation (RF) is emerging as the standard of care for treatment of atrial fibrillation (AF). While procedural short-term to midterm efficacy and efficiency are very promising, this registry aims to investigate esopahgeal safety using an optimized ablation approach. METHODS: In a single-center experience, 388 consecutive standardized first-time AF ablation were performed using a CLOSE-guided-fixed-50 W-circumferential PVI and substrate modification without intraprocedural esophageal temperature measurement. Three hundred patients underwent postprocedural esophageal endoscopy to diagnose and grade endoscopically detected esophageal lesions (EDEL) and were included in the analysis. RESULTS: EDEL were detected in 35 of 300 patients (11.6%), 25 of 35 were low-grade Kansas-city-classification (KCC) 1 lesions with fast healing tendencies. Six patients suffered KCC 2a lesions, 4 patients had KCC 2b lesions (1.3% of all patients). No esophageal perforation or fistula formation was observed. Patient baseline characteristics, especially patients age, gender, and body mass index did not influence EDEL incidence. Additional posterior box isolation did not increase the incidence of EDEL. In patients diagnosed with EDEL, mean catheter contact force during posterior wall ablation was higher (11.9 ± 1.8 vs. 14.7 ± 3 g, p < .001), mean RF duration was shorter (11.9 ± 1 vs. 10.7 ± 1.2 s, p < .001), while achieved ablation index was not different between groups (434 ± 4.9 vs. 433 ± 9.5, n.s.). CONCLUSION: Incidence of EDEL after CLOSE-guided-50 W-HPSD PVI is lower compared to historical cohorts using standard-power RF settings. Catheter contact force during posterior HPSD ablation should not exceed 15 g.

Short term outcome after left atrial appendage occlusion with the AMPLATZER Amulet and WATCHMAN device: results from the ORIGINAL registry (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure).

BACKGROUND: Various randomized multicenter studies have shown that percutaneous left atrial appendage closure (LAAC) is not inferior in stroke prevention compared to vitamin K antagonists (VKA) and can be performed safely and effectively. AIMS: The prospective multicenter ORIGINAL registry in the Free State of Saxony (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure) investigated the efficiency and safety of LAAC with Watchman or Amulet device in a real word setting. A special focus was put on the influence of LAAC frequency on periprocedural efficiency and safety. METHODS AND RESULTS: The total of 482 consecutive patients (Abbott Amulet N = 93 and Boston Scientific Watchman N = 389) were included in the periinterventional analyses. After 6 weeks, 353 patients completed the first follow-up including transoesophageal echocardiography (TEE) (73.2%). Successful LAAC could be performed in more than 94%. The complication rate does not significantly differ between device types (p = 0.92) according to Fischer test and comprised 2.2% in the Amulet and 2.3% in the Watchman group. The kind of device and the frequency of LAAC per study center had no influence on the success and complication rates. Device related thrombus could be revealed more frequently in the Watchman group (4.5%) than in the Amulet group (1.4%) but this difference is still not significant in Fisher test (p = 0.14). Same conclusion can be made about residual leakage 1.1% versus 0% [not significant in Fisher test (p = 0.26)]. Dual antiplatelet therapy followed the intervention in 64% and 22% of patients were discharged under a combination of an anticoagulant (VKA/DOAC/Heparin) and one antiplatelet agent. CONCLUSIONS: The ORIGINAL registry supports the thesis from large, randomized trials that LAAC can be performed with a very high procedural success rate in the everyday clinical routine irrespective of the used LAA device (Watchman or Amulet). The postprocedural antithrombotic strategy differs widely among the participating centers. Trial registration Name of the registry: "saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure", Trial registration number: DRKS00023803; Date of registration: 15/12/2020 'Retrospectively registered'; URL of trial registry record: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023803 .

Procedural efficacy and safety of standardized, ablation index guided fixed 50 W high-power short-duration pulmonary vein isolation and substrate modification using the CLOSE protocol.

INTRODUCTION: Ablation index (AI)-guided ablation according to the CLOSE protocol is very effective in terms of chronic pulmonary vein isolation (PVI). However, the optimal radiofrequency (RF) power remains controversial. Here, we thought to investigate the efficiency and safety of an AI-guided fixed circumferential 50 W high-power short-duration (HPSD) PVI using the CLOSE protocol. METHODS AND RESULTS: In a single-center trial, 40 patients underwent randomized PVI using AI-guided ablation without esophageal temperature monitoring. In 20 patients a CLOSE protocol guided fixed 50 W HPSD was followed irrespective of the anatomical localization. Twenty subjects were treated according to the CLOSE protocol with standard power settings (20 W posterior and 40 W roof and anterior wall). In addition, 80 consecutive patients were treated according to the HPSD protocol to gather additional safety data. All patients underwent postprocedural esophagogastroduodenoscopy to reveal esophageal lesions (EDELs). The mean total procedural time was 80.3 ± 22.5 in HPSD compared to control 109.1 ± 27.4 min (p < .001). The total RF-time was significantly lower in HPSD with 1379 ± 505 s versus control 2374 ± 619 s (p < .001). There were no differences in periprocedural complications. EDEL occurred in 13% in the HPSD and 10% in the control group. EDEL occurring in the 50 W HSDP patients were smaller, more superficial, and had a faster healing tendency. CONCLUSION: A fixed 50 W HPSD circumferential PVI relying on the AI and CLOSE protocol reduce the total procedure time and the total RF time, without increasing the complication rates. The incidence of EDELs was similar using 50 W at the posterior atrial wall.

The effects of interventional mitral valve repair using the MitraClip System on the results of pulmonary function testing, pulmonary pressure and diffusing capacity of the lung.

BACKGROUND: The study analyzes changes in lung function, pulmonary pressure and diffusing capacity of the lung in patients with mitral valve regurgitation (MR) treated by MitraClip implantation. METHODS: A total of 43 patients (19 women and 24 men with an average age of 78.0 ± 6.6 years) who were able to perform pulmonary function testing including diffusing capacity of the lung for carbon monoxide (DLCO), vital capacity (VC), total lung capacity (TLC), residual volume (RV) and forced expiratory volume in 1 s (FEV1) before and 6 weeks after MitraClip implantation participated in this study. Furthermore, clinical and echocardiographic parameters including systolic pulmonary artery pressure (sPAP), left ventricular ejection fraction (LVEF) and left atrial diameter (LAD) measurements were recorded in all patients. RESULTS: The procedure was performed successfully in all 43 patients leading to a reduction of MR in 97.7% of cases. One patient died on day 4 after the intervention most likely due to pulmonary artery embolism. Six weeks after the implantation 79.1% of patients showed a MR of at most mild to moderate. Furthermore, we could demonstrate a significant reduction of systolic pulmonary artery pressure during follow-up (from 48.8 ± 11.4 mmHg to 42.9 ± 9.0 mmHg (t(41) = - 2.6, p = 0.01). However, no changes in LVEF were detected. Comparing pre and post implant lung function tests, no significant alterations were seen for VC, TLC, DLCO and FEV1. Though, in a subgroup of patients with moderate to severe preexisting deterioration of DLCO at the baseline (max. 50%) the MitraClip procedure resulted in a significant improvement in DLCO (37.8% ± 9.0 to 41.6% ± 10.0, p < 0.001). CONCLUSIONS: Treatment of MR with the MitraClip system successfully reduces MR severity in the vast majority of patients. Consecutively, a reduction in pulmonary pressure could be observed, however no changes in LVEF were obvious. Lung function tests remained unaltered during follow-up. However, in a subgroup of patients with severe preexisting deterioration of DLCO the MitraClip procedure resulted in a significant improvement in DLCO. TRIAL REGISTRATION: Name of the registry: Die Auswirkung der interventionellen Mitralklappenreparatur mit MitraClip-System auf die Ergebnisse der Lungenfunktionsmessung. TRIAL REGISTRATION NUMBER: DRKS00022435; Date of registration: 09/07/2020 'Retrospectively registered'; URL of trial registry record: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00022435 .

Evaluation of heart involvement in calpainopathy (LGMD2A) using cardiovascular magnetic resonance.

INTRODUCTION: Cardiac dysfunction occurs in several forms of limb girdle muscular dystrophy (LGMD). The aim of this study was to investigate cardiac involvement in calpainopathy (LGMD2A). METHODS: Cardiovascular evaluation was performed in 10 patients with genetically verified LGMD2A by echocardiography, 3 Tesla - cardiovascular magnetic resonance, 24-h electrocardiography recordings with heart rate variability (HRV) analysis, and 24-h blood pressure recordings. RESULTS: No patient with calpainopathy showed impairment of left or right ventricular function. One patient had a small amount (2% of left ventricle mass) of late gadolinium enhancement. HRV analysis revealed no significant difference compared with external reference data. CONCLUSIONS: The main finding of this study is the lack of cardiac involvement in patients with calpainopathy. Cardiac involvement was not found, even in individuals with advanced age and greater disease severity. Furthermore, we did not observe an overall reduction of cardiac autonomic regulation in calpainopathy.

Soluble ST2 and myocardial fibrosis in 3T cardiac magnetic resonance.

OBJECTIVE: The soluble form of ST2 (sST2) is a novel laboratory parameter for cardiac risk prediction, and over the past years, several studies have tried to evaluate its utility, especially in the management of heart failure. We investigated whether increased serum levels of sST2 show a characteristic pathomorphologic pattern in 3-Tesla cardiac magnetic resonance imaging (CMRI). METHODS: One hundred and fifty-six patients referred to 3T CMRI due to suspected coronary artery disease (CAD) or myocarditis were prospectively enrolled in the study. Ninety patients were diagnosed with CAD, 22 patients with myocarditis, and 44 patients, who constituted the reference group, showed no pathologic CMRI pattern. RESULTS: There was no significant difference between the sST2 values for patients in the reference group and patients with CAD or myocarditis. The sST2 concentration showed a weak correlation with the NYHA functional class (P = 0.002, r = 0.22), but correlation of sST2 and LGE, left ventricular parameters, and LVEF could not be seen. In contrast NT-proBNP was positively correlated to left ventricular parameters, LGE, and NYHA class function (P < 0.05). Additionally, it showed an inverse relationship to LVEF (P < 0.001, r = - 0.42). CONCLUSIONS: Soluble ST2 is not able to detect myocardial scar and should not be used alone as a parameter for detection of inflammation and myocardial scar formation.

3-T magnetic resonance for determination of aortic valve area: a comparison to echocardiography.

OBJECTIVES: For evaluation of aortic valve area (AVA), transthoracic echocardiography (TTE) is the method of choice. Cardiac magnetic resonance (CMR) at 1.5-Tesla is an alternative. The aim of the study was to check whether quantification of whole range of AVA without severe aortic stenosis is possible and reliable in higher magnetic field strength, and also including a comparison to TTE. METHODS: In 3-T CMR phase contrast sequences were assessed above aortic valve and left ventricular output tract. AVA was calculated using the continuity equation. Planimetric analysis of AVA was performed in magnitude images. TTE was used as reference method for graduation of AVA. RESULTS: Totally 48 patients (64 ± 18 years) without severe aortic valve stenosis were prospectively enrolled. In CMR planimetric AVA was 2.5 ± 1.3 cm(2) and calculated AVA 2.4 ± 1.3 cm(2), whereas AVA in TTE was 1.9 ± 1.1 cm(2). Planimetric and calculated AVA in CMR and also AVA in CMR and TTE showed good correlation (r = 0.97, 0.92, respectively). Bland-Altman analysis demonstrated no signs of over- or underestimation. Inter- and intraobserver variabilities were low. DISCUSSION: Determination of AVA using 3-T CMR is possible using direct planimetry and continuity equation. CMR is the alternative first choice method in cases with discrepant or insufficient echocardiographic results.

Safety and Efficiency of Cephalic Vein Puncture by Modified Seldinger Technique Compared to Subclavian Vein Puncture for Cardiac Implantable Electronic Devices.

INTRODUCTION: The establishment of venous access is one of the driving factors for complications during implantation of pacemakers and defibrillators (cardiac implantable electronic devices [CIED]). Recently, a novel approach of accessing the cephalic vein for CIED by cephalic vein puncture (CVP) using a modified Seldinger technique has been described, promising high success rates and simplified handling with steeper learning curves. In this single-center registry, we analyzed the safety and efficiency of CVP to SVP access after defining CVP as the primary access route in our center. METHODS: A total of 229 consecutive patients receiving a CIED were included in the registry. Sixty-one patients were implanted by primary or bail-out SVP; 168 patients received primary cephalic preparation and CVP was performed when possible, using a hydrophilic transradial sheath. RESULTS: Implantation of at least one lead via CVP was successful in 151 of 168 patients (90%), and implantation of all leads was possible in 122 of 168 patients (72.6%). Total implantation times and fluoroscopy times and doses did not differ between CVP and SVP implantations. Pneumothorax occurred in 0/122 patients implanted via CVP alone, but 8/107 (7.5%) patients received at least one lead via SVP. CONCLUSION: Our data confirms high success rates of the CVP for CIED implantation. Moreover, this method can be used without significantly prolonging the total procedure time or applying fluoroscopy dose compared to the highly efficient SVP while showing lower overall complication rates.

Right ventricular reduction for repair of functional tricuspid valve regurgitation: one-year follow up.

BACKGROUND AND AIM OF THE STUDY: The study aim was to assess the impact of reducing the right ventricular (RV) cavity in order to optimize the outcome of tricuspid valve (TV) repair in cases of functional tricuspid regurgitation (FTR) with dilated right ventricle. METHODS: Between May 2007 and February 2010, a total of 17 patients (six males, 11 females; mean age 69.5 +/- 10.1 years; mean logistic EuroSCORE 24 +/- 13%) with severe FTR and severe RV dilation were included. Echocardiography and magnetic resonance imaging (MRI) were performed for geometric assessment of the right ventricle. Intraoperatively, the lateral RV free wall was plicated to reduce the RV cavum to approximate the papillary muscles and decrease tethering of the TV; a conventional ring annuloplasty was then performed. Follow up included echocardiography and MRI at one month and one year postoperatively. RESULTS: The mean operative time was 157 +/- 30 min, and the cross-clamp time 63 13 min. Postoperatively, the mean bleeding volume was 486 +/- 455 ml, the rethoracotomy rate 5.9%, intensive therapy unit (ITU) stay 6.0 +/- 4.4 days, and hospital stay 19.0 +/- 8.8 days. In-hospital mortality was 17.6%. The mean follow up was 14.4 +/- 2.4 months. The one-year follow up revealed a survival of 82.3%, a slight decrease in RV ejection fraction (from 33.5 +/- 4.2% to 31.7 +/- 5.7%; p = 0.13), a significant reduction in the RV end-diastolic volume index (from 160 +/- 15.6 to 128 +/- 10 ml/m2; p = 0.0001), a reduction in TV tenting area (from 3.3 +/- 0.9 to 0.9 +/- 0.3 cm2; p = 0.0001), and a significant reduction in the ratio of TR jet to right atrial surface area (from 54.8 +/- 8.2% to 14.1 +/- 3.5%; p = 0.0001). CONCLUSION: In cases of FTR, RV dilation may be considered as a correctable factor at subvalvular level to optimize the outcome of TV repair.