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Aims Simplified ablation technologies for pulmonary vein isolation (PVI) are increasingly performed worldwide. One of the most common complications following PVI are vascular access-related complications. Lately, venous closure systems (VCSs) were introduced into clinical practice, aiming to reduce the time of bed rest, to increase the patients' comfort, and to reduce vascular access-related complications. The aim of the present study is to compare the safety and efficacy of using a VCS to achieve haemostasis following single-shot PVI to the actual standard of care [figure-of-eight suture and manual compression (MC)]. Methods and results This is a prospective, multicentre, randomized, controlled, open-label trial performed at three German centres. Patients were randomized 1:1 to undergo haemostasis either by means of VCS (VCS group) or of a figure-of-eight suture and MC (F8 group). The primary efficacy endpoint was the time to ambulation, while the primary safety endpoint was the incidence of major periprocedural adverse events until hospital discharge. A total of 125 patients were randomized. The baseline characteristics were similar between the groups. The VCS group showed a shorter time to ambulation [109.0 (82.0, 160.0) vs. 269.0 (243.8, 340.5) min; P < 0.001], shorter time to haemostasis [1 (1, 2) vs. 5 (2, 10) min; P < 0.001], and shorter time to discharge eligibility [270 (270, 270) vs. 340 (300, 458) min; P < 0.001]. No major vascular access-related complication was reported in either group. A trend towards a lower incidence of minor vascular access-related complications on the day of procedure was observed in the VCS group [7 (11.1%) vs. 15 (24.2%); P = 0.063] as compared to the control group. Conclusion Following AF ablation, the use of a VCS results in a significantly shorter time to ambulation, time to haemostasis, and time to discharge eligibility. No major vascular access-related complications were identified. The use of MC and a figure-of-eight suture showed a trend towards a higher incidence of minor vascular access-related complications. [ABSTRACT FROM AUTHOR]

Aims: Simplified ablation technologies for pulmonary vein isolation (PVI) are increasingly performed worldwide. One of the most common complications following PVI are vascular access-related complications. Lately, venous closure systems (VCSs) were introduced into clinical practice, aiming to reduce the time of bed rest, to increase the patients' comfort, and to reduce vascular access-related complications. The aim of the present study is to compare the safety and efficacy of using a VCS to achieve haemostasis following single-shot PVI to the actual standard of care [figure-of-eight suture and manual compression (MC)]., Methods and Results: This is a prospective, multicentre, randomized, controlled, open-label trial performed at three German centres. Patients were randomized 1:1 to undergo haemostasis either by means of VCS (VCS group) or of a figure-of-eight suture and MC (F8 group). The primary efficacy endpoint was the time to ambulation, while the primary safety endpoint was the incidence of major periprocedural adverse events until hospital discharge. A total of 125 patients were randomized. The baseline characteristics were similar between the groups. The VCS group showed a shorter time to ambulation [109.0 (82.0, 160.0) vs. 269.0 (243.8, 340.5) min; P < 0.001], shorter time to haemostasis [1 (1, 2) vs. 5 (2, 10) min; P < 0.001], and shorter time to discharge eligibility [270 (270, 270) vs. 340 (300, 458) min; P < 0.001]. No major vascular access-related complication was reported in either group. A trend towards a lower incidence of minor vascular access-related complications on the day of procedure was observed in the VCS group [7 (11.1%) vs. 15 (24.2%); P = 0.063] as compared to the control group., Conclusion: Following AF ablation, the use of a VCS results in a significantly shorter time to ambulation, time to haemostasis, and time to discharge eligibility. No major vascular access-related complications were identified. The use of MC and a figure-of-eight suture showed a trend towards a higher incidence of minor vascular access-related complications., Competing Interests: Conflict of interest: R.R.T. is a consultant for Boston Scientific, Biotronik, Biosense Webster, and Abbott Medical, and he received speaker’s honoraria from Boston Scientific, Biotronik, Biosense Webster, Abbott Medical, and Lifetech and research grants from Abbott, Biosense Webster, and Lifetech. C.-H.H. received travel grants and research grants from Abbott Medical, Boston Scientific, Medtronic, Lifetech, Biosense Webster, and CardioFocus. He is a consultant for Boston Scientific, Biosense Webster, and Lifetech and received speaker honoraria from Abbott Medical, Boston Scientific, Medtronic, Biosense Webster, CardioFocus, Pfizer, BMS, C.T.I. GmbH, and Doctrina Med. K.-H.K. reports grants and personal fees from Abbott Vascular, Medtronic, and Biosense Webster outside the submitted work. C.E. received travel grants and research grants from Abbott, Boston Scientific, and Biosense Webster and speaker honoraria from Abbott, Boston Scientific, Biosense Webster, C.T.I. GmbH, and Doctrina Med. S.S.P. received travel grants and congress grants from Lifetech and an Educational Grant and speaker honoraria from Abbott Medical. J.V. received honoraria for lectures / talks: Abbott, Astra Zeneca, Pfizer, Boston Scientific, C.T.I., Doctrina Med, Medtronic and travel grants: Medtronic, Boston Scientific, Abbott, and is proctor for Boston Scientific. P.S. is Member of Advisory Board of Abbott, Biosense Webster, Boston Scientific and Medtronic. All other authors have no relevant disclosures., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: In patients with a total cavopulmonary connection in Fontan circulation, the access to the common atrium (CA) during a catheter ablation can be challenging, even in the presence of fenestration in an intra-atrial lateral tunnel (IALT). In our department, the fenestration is typically marked with metal clips (MCs). To the best of our knowledge, there is no previous report of balloonoplasty of clipped fenestration., Case Summary: A 19-year-old male with hypoplastic left heart syndrome (HLHS) was scheduled for catheter ablation of recurrent atrial tachycardia. He was diagnosed with HLHS prenatally and underwent a stepwise surgical palliation. Fontan circulation was completed with the creation of a fenestrated IALT. The fenestration was marked by four MCs. During the ablation procedure, the passage of the steerable sheath with mapping catheter to the CA was prevented by a small fenestration size and rigidness of the edges of the fenestration caused by the MCs. Multiple attempts to dilate the fenestration using a peripheric angioplasty balloon failed. Only angioplasty with the 'balloon-against-dilator' technique was finally successful. Activation map showed a counterclockwise atrial flutter in the CA; successful ablation was performed., Discussion: We present a case of challenging access to the CA through a clipped fenestration in a polytetrafluoroethylene baffle for atrial tachycardia ablation. Even though a tunnel fenestration in Fontan patients facilitates access to the CA, the passage of a steerable introducer with a mapping catheter may be challenging due to diameter mismatch and the rigidity of its edges caused by MCs. The balloon-against-dilator technique might be helpful when conventional balloon angioplasty fails., Competing Interests: Conflict of interest: None declared., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Nonischemic dilated cardiomyopathies (DCM) are the most common reason for heart failure in developed countries after ischemic disease. They often lead to device therapy. Left ventricular ejection fraction as a single parameter to identify patients at risk for sudden cardiac death revealed inconclusive data in patients with DCM., Methods: Autonomic tone, measured by classical and innovative parameters of heart rate variability (HRV), heart rate turbulence or baroreceptor reflex, was demonstrated to give valuable prognostic information especially in patients with ischemic disease and after acute myocardial infarction. In patients with DCM, classical parameters of HRV showed inhomogeneous data in a heterogeneous patient collective caused by unsystematic measurement of single parameters in various patient collectives., Results: Innovative parameters of HRV are promising in patients with DCM and showed prognostic relevance although patient numbers are limited and prospective data are missing. Further studies are needed in this field., Conclusion: Despite the in part convincing evidence for the relevance of autonomic tone as a prognostic marker in patients with DCM, their evaluation is still not part of clinical routine. Additional parameters to estimate the risk of sudden cardiac death are urgently needed.