110 results on '"Nentwich K"'
Search Results
2. First experiences with protected VT ablation using surgical Impella 5.5
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Nentwich, K, primary, Ene, E, additional, Hijazi, H, additional, Berkowitz, A, additional, Lenos, A, additional, and Deneke, T, additional
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- 2024
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3. Diagnose und Behandlung ventrikulärer Extrasystolen
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Ene, E., Nentwich, K., Halbfaß, P., Sonne, K., Berkovitz, A., and Deneke, T.
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- 2019
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4. Verschluss des linken Herzohrs als therapeutische Alternative
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Nentwich, K., Ene, E., Halbfass, P., Sonne, K., Berkowitz, A., Kerber, S., and Deneke, T.
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- 2019
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5. Epikardiales Mapping und Ablation bei ventrikulären Tachykardien: Bei wem, wann, wie und mit welchen Erfolgsaussichten?
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Ene, E., Halbfaß, P., Nentwich, K., Sonne, K., Berkovitz, A., Wolf, A.-K., and Deneke, T.
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- 2018
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6. Midterm results of bipolar ablation in patients with intramural substrate and recurrent VTs based on a single center experience
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Ene, E, primary, Nentwich, K, additional, Deaconu, A, additional, Berkovitz, A, additional, Halbfass, P H, additional, Sonne, K, additional, and Deneke, T, additional
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- 2023
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7. Clinical features of cardiac sarcoidosis in a cohort treated with epi- and endocardial VT ablation
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Nentwich, K, primary, Ene, E, additional, Berkowitz, A, additional, Sonne, K, additional, and Deneke, T, additional
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- 2023
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8. Kommentar zum periprozeduralen Management der Antikoagulation
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Halbfaß, P., Nentwich, K., Ene, E., Sonne, K., and Deneke, T.
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- 2017
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9. Epikardiale Ablation ventrikulärer Tachykardien
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Ene, E., Halbfaß, P., Nentwich, K., Sonne, K., Roos, M., Fodor, S., Lehmkuhl, L., Gietzen, F., Barth, S., Hamm, K., and Deneke, T.
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- 2017
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10. Pulsed field ablation for atrial fibrillation: acute procedural efficacy and safety of an initial German multicenter experience
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Gunawardene, M A, primary, Lemoine, M, additional, Deneke, T, additional, Wakili, R, additional, Steven, D, additional, Schaeffer, B, additional, Rillig, A, additional, Nentwich, K, additional, Siebermair, J, additional, Filipovic, K, additional, Simu, G, additional, Riesinger, L, additional, Sultan, A, additional, Willems, S, additional, and Metzner, A, additional
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- 2022
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11. Efficacy and safety of VT ablation of electrical storm
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Mueller, J, primary, Nentwich, K, additional, Berkovitz, A, additional, Halbfass, P, additional, Ene, E, additional, Sonne, K, additional, Simu, GR, additional, Chakarov, I, additional, and Deneke, T, additional
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- 2022
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12. Prognosis of patients with and without septal substrate after VT ablation due to electrical storm
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Mueller, J, primary, Nentwich, K, additional, Berkovitz, A, additional, Halbfass, P, additional, Ene, E, additional, Sonne, K, additional, Simu, GR, additional, Chakarov, I, additional, and Deneke, T, additional
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- 2022
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13. Acute safety and efficacy outcome of pulmonary vein isolation using pulsed field ablation technology
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Nentwich, K, primary, Ene, EE, additional, Berkowitz, AB, additional, Simu, GS, additional, Sonne, KS, additional, Mueller, JM, additional, and Deneke, TD, additional
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- 2022
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14. Uterustumor, HCG-Exzess und Hyperthyreose bei 51-jähriger Patientin
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Mödl, B.M., Nentwich, K., Hitzler, H.J., Lorch, R., Keller, E., and Pfafferott, C.
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- 2001
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15. Hyperthyreose durch HCG-Exzeß bei Blasenmole
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Mödl, B., primary, Nentwich, K., additional, Hitzler, H.-J., additional, Pfafferott, C., additional, Lorch, R., additional, and Keller, E., additional
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- 2000
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16. P338Epicardial ligation of the left atrial appendage for antiarrhythmic indication
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Nentwich, K M, primary, Ene, E E, additional, Halbfass, P H, additional, Sonne, K S, additional, Kerber, S K, additional, and Deneke, T D, additional
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- 2018
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17. Epikardiale Ablation ventrikulärer Tachykardien – wann und wie?
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Ene, E., additional, Halbfass, P., additional, Nentwich, K., additional, Roos, M., additional, Szöllösi, A., additional, Sonne, K., additional, and Deneke, T., additional
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- 2016
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18. Indikationen zur Katheterablation bei ventrikulärer Tachykardie
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Deneke, T., additional, Israel, C., additional, Krug, J., additional, Nentwich, K., additional, Müller, P., additional, Mügge, A., additional, and Schade, A., additional
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- 2013
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19. Incidence of silent cerebral lesions using different ablation technologies
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Deneke, T., primary, Bansmann, M., additional, Nentwich, K., additional, Krug, J., additional, Majewski, P., additional, Schmitt, R., additional, Muegge, A., additional, Mueller, P., additional, Shin, D.- I., additional, and Schade, A., additional
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- 2013
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20. Ein Patient mit Aortenstenose und schwerer Ausflussbahn-Obstruktion
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Nentwich, K, primary and Flachskampf, F, additional
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- 2010
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21. P.1.28 Cryomapping and cryoablation of arrhythmogenic structures close to the AV node
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Neuser, H., primary, Nentwich, K., additional, Kerber, S., additional, and Schumacher, B., additional
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- 2003
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22. Rezidivierende Hämoptysen als Erstsymptom einer thorakalen Angiomatose beim Erwachsenen
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Bastian, D., primary, Mödl, B., additional, Nentwich, K., additional, Engel, G., additional, Brunner, E., additional, and Holper, K., additional
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- 2002
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23. P.1.28 Cryomapping and cryoablation of arrhythmogenic structures close to the AV node.
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Neuser, H., Nentwich, K., Kerber, S., and Schumacher, B.
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- 2002
24. Cardiac sarcoidosis in patients with recurrent ventricular arrhythmias refractory to endocardial ablation.
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Nentwich K, Klingel K, Ene E, Müller J, Berkowitz A, Barth S, and Deneke T
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Introduction: The clinical presentation of cardiac sarcoidosis is diverse. Detection of granuloma in histopathological evaluation proves the diagnosis, but endomyocardial biopsy (EMB) is associated with a high sampling error. However, prompt immunosuppressive therapy may significantly affect patient's prognosis. By analyzing our single center cohort of patients with recurrent ventricular arrhythmias (VA) and nonischemic cardiomyopathy after failure of endocardial ablation, we looked for additional markers supporting the diagnosis of cardiac sarcoidosis., Method: In the last 4 years, 135 patients (mean age 49 y, 63% male) were hospitalized for epicardial ventricular arrhythmia (VA) ablation after failure of endocardial ablation. Nineteen patients had either previously received a diagnosis of cardiac sarcoidosis or were newly diagnosed. The mean follow-up time was 4.3 years. The ECG criteria, primary manifestation, histological findings in EMB, history of VT ablation, distribution of scars on MRI, electroanatomical mapping (EAM), PET CT findings, presence of atrial tachycardias, valve disease and comorbidities were analyzed., Results: Six of 19 (32%) patients showed right bundle block; 6 of 19 (32%) had AV nodal disease, including 4 patients with AV-block III; and 14 patients (73%) primarily presented with ventricular arrhythmias (including 3 with cardiac arrest). In all 19 patients cardiac EMB revealed elevated CD68 macrophages and CD3 T lymphocytes, and 7 of 19 were positive for granuloma (36,8%). Six of 6 patients (100%) undergoing PET CT showed acute inflammation. By analyzing the scar distribution, the most common locations were basal anteroseptal, basal inferoseptal, mid inferoseptal, mid inferior and the septal RV/RVOT. (septal substrate in 100%). There was a high correlation between the findings on the MRIs and low voltage in the electroanatomical mapping EAM). All patients received an immunosuppressive therapy. No patient died during follow-up, 1 patient had a high urgent heart transplant after withdrawal of steroid therapy., Conclusion: Chronic untreated inflammation may be the underlying pathophysiology for patients with unspecific cardiomyopathy and recurrent VA refractory to endocardial and epicardial ablation. Septal substrate in the EAM/MRI, elevated CD3 lymphocytes in the EBM and inflammation in the PET CT may indicate the possible diagnosis of cardiac sarcoidosis. Initializing immunosuppressive therapy in patients with this dedicated constellation with should be taken into consideration., (© 2024. Springer-Verlag GmbH Germany, part of Springer Nature.)
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- 2024
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25. Prognostic value of non-invasive programmed ventricular stimulation after VT ablation to predict VT recurrences.
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Müller J, Chakarov I, Nentwich K, Berkovitz A, Barth S, Ausbüttel F, Wächter C, Lehrmann H, and Deneke T
- Abstract
Background: The prognostic value of (non)-invasive programmed ventricular stimulation (NIPS) to predict recurrences of ventricular tachycardia (VT) is under discussion. Optimal endpoints of VT ablation are not well defined, and optimal timepoint of NIPS is unknown. The goal of this study was to evaluate the ability of programmed ventricular stimulation at the end of the VT ablation procedure (PVS) and NIPS after VT ablation to identify patients at high risk for VT recurrence., Methods: Between January 2016 and February 2022, consecutive patients with VT and structural heart disease undergoing first VT ablation and consecutive NIPS were included. In total, 138 patients were included. All patients underwent NIPS through their implanted ICDs after a median of 3 (1-5) days after ablation (at least 2 drive cycle lengths (500 and 400 ms) and up to four right ventricular extrastimuli until refractoriness). Clinical VT was defined by comparison with 12-lead electrocardiograms and stored ICD electrograms from spontaneous VT episodes. Patients were followed for a median of 37 (13-61) months., Results: Of the 138 patients, 104 were non-inducible (75%), 27 were inducible for non-clinical VTs (20%), and 7 for clinical VT (5%). In 107 patients (78%), concordant results of PVS and NIPS were observed. After 37 ± 20 months, the recurrence rate for any ventricular arrhythmia was 40% (normal NIPS 29% vs. inducible VT during NIPS 66%; log-rank p = 0.001) and for clinical VT was 3% (normal NIPS 1% vs. inducible VT during NIPS 9%; log-rank p = 0.045). Positive predictive value (PPV) and negative predictive value (NPV) of NIPS were higher compared to PVS (PPV: 65% vs. 46% and NPV: 68% vs. 61%). NIPS revealed the highest NPV among patients with ICM and LVEF > 35%. Patients with inducible VT during NIPS had the highest VT recurrences and overall mortality. Patients with both negative PVS and NIPS had the lowest any VT recurrence rates with 32%. Early re-ablation of patients with recurrent VTs during index hospitalization was feasible but did not reveal better long-term VT-free survival., Conclusions: In patients after VT ablation and structural heart disease, NIPS is superior to post-ablation PVS to stratify the risk of VT recurrences. The PPV and NPV of NIPS at day 3 were superior compared to PVS at the end of the procedure to predict recurrent VT, especially in patients with ICM., (© 2024. The Author(s).)
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- 2024
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26. A screening for cerebral deoxygenation during VT ablations in patients with structural heart disease.
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Müller J, Koch L, Halbfass P, Nentwich K, Berkovitz A, Barth S, Wächter C, Lehrmann H, and Deneke T
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Background: Patients undergoing ventricular tachycardia (VT) ablation often present with structural heart disease (SHD) and reduced ejection fraction. Inducing VT by programmed electrical stimulation (PES) puts these patients at risk for hemodynamic instability and cerebral hypoperfusion., Objective: The present study screens for cerebral oxygen desaturation phases (ODPs) in patients undergoing VT ablation., Methods: Forty-seven patients (age 61 ± 14 years, 72% males) underwent ablation of sustained VT with simultaneous neuromonitoring using near-infrared spectroscopy (NIRS)., Results: Analysis of NIRS signal identified ODPs in 29 patients (62%). ODPs were associated with a higher prevalence of ischemic heart disease (IHD) (45% vs. 11%, p = 0.024), previous VT episodes (n = 16 vs. 4, p = 0.018), and VTs inducible by PES (n = 2.4 vs. 1.2, p = 0.004). Patients with ODPs were more likely to be admitted to intensive care unit (ICU) (78% vs. 33%, p = 0.005) and had more in-hospital VT recurrences (24% vs. 0%, p = 0.034). No differences were observed in VT recurrence rates after hospital discharge (41.4% vs. 44.4%, p = 0.60) and left ventricular ejection fraction (34% vs. 38%, p = 0.567). IHD (OR: 32.837, p = 0.006), ICU admission (OR: 14.112, p = 0.013), and the number of VTs inducible at PES (OR: 2.705, p = 0.015) were independently associated with ODPs., Conclusions: This study registers episodes of cerebral hypoperfusion in 62% of patients undergoing VT ablation and identifies IHD and the number of VTs inducible at PES as possible risk factors for these episodes., (© 2024. The Author(s).)
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- 2024
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27. Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study.
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Ekanem E, Neuzil P, Reichlin T, Kautzner J, van der Voort P, Jais P, Chierchia GB, Bulava A, Blaauw Y, Skala T, Fiala M, Duytschaever M, Szeplaki G, Schmidt B, Massoullie G, Neven K, Thomas O, Vijgen J, Gandjbakhch E, Scherr D, Johannessen A, Keane D, Boveda S, Maury P, García-Bolao I, Anic A, Hansen PS, Raczka F, Lepillier A, Guyomar Y, Gupta D, Van Opstal J, Defaye P, Sticherling C, Sommer P, Kucera P, Osca J, Tabrizi F, Roux A, Gramlich M, Bianchi S, Adragão P, Solimene F, Tondo C, Russo AD, Schreieck J, Luik A, Rana O, Frommeyer G, Anselme F, Kreis I, Rosso R, Metzner A, Geller L, Baldinger SH, Ferrero A, Willems S, Goette A, Mellor G, Mathew S, Szumowski L, Tilz R, Iacopino S, Jacobsen PK, George A, Osmancik P, Spitzer S, Balasubramaniam R, Parwani AS, Deneke T, Glowniak A, Rossillo A, Pürerfellner H, Duncker D, Reil P, Arentz T, Steven D, Olalla JJ, de Jong JSSG, Wakili R, Abbey S, Timo G, Asso A, Wong T, Pierre B, Ewertsen NC, Bergau L, Lozano-Granero C, Rivero M, Breitenstein A, Inkovaara J, Fareh S, Latcu DG, Linz D, Müller P, Ramos-Maqueda J, Beiert T, Themistoclakis S, Meininghaus DG, Stix G, Tzeis S, Baran J, Almroth H, Munoz DR, de Sousa J, Efremidis M, Balsam P, Petru J, Küffer T, Peichl P, Dekker L, Della Rocca DG, Moravec O, Funasako M, Knecht S, Jauvert G, Chun J, Eschalier R, Füting A, Zhao A, Koopman P, Laredo M, Manninger M, Hansen J, O'Hare D, Rollin A, Jurisic Z, Fink T, Chaumont C, Rillig A, Gunawerdene M, Martin C, Kirstein B, Nentwich K, Lehrmann H, Sultan A, Bohnen J, Turagam MK, and Reddy VY
- Subjects
- Humans, Female, Male, Middle Aged, Aged, Treatment Outcome, Postoperative Complications epidemiology, Postoperative Complications etiology, Atrial Fibrillation surgery, Atrial Fibrillation therapy, Catheter Ablation adverse effects, Catheter Ablation methods
- Abstract
Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for ~1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF., (© 2024. The Author(s).)
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- 2024
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28. Safety and Effectiveness of Pulsed Field Ablation for Atrial Fibrillation in Patients With Heart Failure.
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Turagam MK, Neuzil P, Schmidt B, Reichlin T, Neven K, Metzner A, Hansen J, Blaauw Y, Maury P, Arentz T, Sommer P, Anic A, Anselme F, Boveda S, Deneke T, Willems S, van der Voort P, Tilz R, Funasako M, Scherr D, Wakili R, Steven D, Kautzner J, Vijgen J, Jais P, Petru J, Chun J, Roten L, Füting A, Lemoine MD, Ruwald M, Mulder BA, Rollin A, Lehrmann H, Fink T, Jurisic Z, Chaumont C, Adelino R, Nentwich K, Gunawardene M, Ouss A, Heeger CH, Manninger M, Bohnen JE, Sultan A, Peichl P, Koopman P, Derval N, Kueffer T, Reinsch N, and Reddy VY
- Abstract
Background: Atrial fibrillation (AF) and heart failure (HF) coexist, increasing morbidity and mortality. Studies have demonstrated improved outcomes following AF ablation in HF patients with reduced ejection fraction (EF)., Objective: This study sought to assess the outcomes of pulsed field ablation (PFA) in HF., Methods: MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a multicenter, patient-level registry of consecutive patients undergoing PFA for paroxysmal AF or persistent AF (PerAF). In this substudy, patients were stratified as no history of HF (no-HF), HF with preserved EF (HFpEF) (left ventricular EF of ≥50%) or HF with reduced/mildly reduced EF (HFmr/rEF) (left ventricular EF of <50%). The primary effectiveness and safety endpoints were freedom from documented atrial arrhythmias lasting ≥30 seconds and major adverse events, respectively., Results: Of the 1,381 patients, 85% (n = 1,174) were no-HF, 6.2% (n = 87) were HFpEF, and 8.6% (n = 120) were HFmr/rEF. No-HF patients had less PerAF than patients with HF (P < 0.001), with no difference between HF subtypes (P = >0.99). The 1-year freedom from atrial arrhythmia was significantly higher in no-HF patients than in those with HFpEF or HFmr/rEF (79.9%, 71.3%, and 67.5%, respectively; P < 0.001) but similar between patients with HFmr/rEF and HFpEF (P = 0.26). However, there was no significant difference in freedom from atrial arrhythmia among patients with no-HF vs HFpEF vs HFmr/rEF for those with paroxysmal AF (82.8%, 82.4%, and 71.7%, respectively; P = 0.09) and PerAF (73.3%, 64.2%, and 64.9%, respectively; P = 0.14). Major adverse event rates were similar between the no-HF, HFpEF, and HFmr/rEF groups (1.9%, 0%, and 2.5%, respectively)., Conclusions: PFA appears to be potentially safe and effective in AF patients with HF. Freedom from atrial arrhythmia post-PFA was higher in patients without a history of HF, with no significant difference between HF subtypes., Competing Interests: Funding Support and Author Disclosures Boston Scientific provided a grant to help fund data collection but was not otherwise involved with study design or analysis and did not have access to this manuscript before submission. Dr Turagam has received consulting fees from Biosense Webster, Boston Scientific Inc, and AltaThera and speaker honoraria from Sanofi and Medtronic. Dr Neuzil has received a grant from the Ministry of Health, Czech Republic, Development of Research Organizations (DRO), Na Homolka Hospital (NHH) (0023884). Dr Schmidt has received speaker fees and research grants from Boston Scientific/Farapulse, Medtronic, Biosense Webster, and Abbott. Dr Reichlin has received research grants from the Swiss National Science Foundation, the Swiss Heart Foundation, and the sitem insel support fund; speaker/consulting honoraria or travel support from Abbott/SJM, Bayer, Biosense Webster, Biotronik, Boston Scientific, Daiichi Sankyo, Medtronic, and Pfizer-BMS; and support for his institution’s fellowship program from Abbott/SJM, Biosense Webster, Biotronik, Boston Journal Pre-proof 21 Scientific, and Medtronic. Dr Neven has received speaker fees from Farapulse, Inc. Dr Metzner has received a research grant and fees from Farapulse. Dr Hansen has received speaker fees and grant support from Biosense Webster and Medtronic. Dr Blaauw has received research grants from Medtronic and Atricure and consulting fees from Abbott, Biosense Webster, Boston Scientific. Dr Sommer has served as a member of the Advisory Board for Abbott, Biosense Webster, Boston Scientific, and Medtronic. He has received modest honoraria from Medtronic. Dr Anic has received consultant fees from Farapulse Inc, Boston Scientific Inc, Galaxy Medical Inc, and Biosense Webster and has performed contracted research for Farapulse Inc, Boston Scientific Inc, Galaxy Medical Inc, and Biosense Webster. Dr Anselme has received consulting fees from Boston Scientific, Medtronic, and Microport CRM. Dr Boveda has received consulting fees from Medtronic, Boston Scientific, Microport, Zoll, and BMS. Dr Deneke has received speaker honoraria from Galaxy Medical, Abbott, and Biotronik, has been a consultant to Farapulse, and has served on a Clinical Events Committee for Boston Scientific. Dr Willems has received grants and personal fees from Abbott, Boston Scientific, and Medtronic and personal fees from Boehringer Ingelheim, Brystol Myers Squibb, Bayer Vital, Accutus, Daiichi, and Farapulse Inc. Dr Tilz has received consulting fees from Boston Scientific, Abbott Medical, Biotronik, and Biosense Webster and speaker honoraria from Boston Scientific, Abbott Medical, Biotronik, and Biosense Webster. Dr Scherr has received an educational grant from Farapulse Inc and is a consultant for Boston Scientific Inc. Dr Wakili has received investigator-initiated funding for research projects (initiated by him) from Bristol Myers Squibb, Pfizer, and Boston Scientific and speaking honoraria from Boston Scientific, Biotronik, and Medtronic. Dr Steven has received speaker fees from Pfizer, Bayer, Abbott, Johnson & Johnson, and Medtronic; grants from Abbott, Johnson & Johnson, and Boston Scientific; and consulting fees from Boston Scientific and Johnson & Johnson. Dr Kautzner has received personal fees from Bayer, Biosense Webster, Boehringer Ingelheim, Medtronic, and Abbott for participation in Scientific Advisory Boards and speaker honoraria from Bayer, Biosense Webster, Biotronik, Boehringer Ingelheim, CathVision, Medtronic, Mylan, Pfizer, ProMed, and Abbott. Dr Jais has received partial funding from L'institut Des Maladies Du Rythme Cardiaque, LIRYC ANR-10-IAHU-04, equity from Farapulse, and consulting fees and a grant from Boston Scientific. Dr Chun has received speaker fees and research grants from Boston Scientific/Farapulse, Medtronic, Biosense Webster, and Abbott. Dr Roten has received research grants from Medtronic, the Swiss National Foundation, the Swiss Heart Foundation, the Immanuel and Ilse Straub Foundation, and the Sitem Insel Support Fund and speaker fees/honoraria from Biosense Webster, Boston Scientific, Abbott, and Medtronic. Dr Lemoine has received a research grant from Farapulse. Dr Rollin has received a research grant from Farapulse. Dr Gunawardene has received grants from Farapulse Inc and Abbott. Dr Heeger has received travel grants and research grants from Boston Scientific, Lifetech, Biosense Webster, and Cardiofocus and speaker honoraria from Boston Scientific, Lifetech. Biosense Webster, Bayer, and Cardiofocus and he has served as a consultant for Medtronic, Journal Pre-proof 22 Lifetech, Boston Scientific, Biosense Webster, and Cardiofocus. Dr Manninger has received speaker fees from Bayer, Biosense Webster, Biotronik, Amomed, AOP Orphan, Boston Scientific, Daiichi Sankyo, and BMS/Pfizer and research grants from Biosense Webster and Abbott. Dr Sultan has received lecture and consulting honoraria from Medtronic, Abbott, and Bayer. Dr Derval has received receiving consulting fees from Boston Scientific. Dr Reddy has received consulting fees (and equity—now divested) from Farapulse Inc; has served as a consultant for Boston Scientific Inc; unrelated to this manuscript, has also served as a consultant for and has equity in Ablacon, Acutus Medical, Affera-Medtronic, Anumana, Apama Medical–Boston Scientific, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, Cardiofocus, CardioNXT/AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EPD-Philips, EP Frontiers, Epix Therapeutics–Medtronic, EpiEP, Eximo, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Kardium, Keystone Heart, Laminar Medical, LuxMed, Medlumics, Middlepeak, Neutrace, Nuvera–Biosense Webster, Oracle Health, Restore Medical, Sirona Medical, SoundCath, and Valcare; unrelated to this work, has served as a consultant for Abbott, Adagio Medical, Append Medical, AtriAN, Biosense Webster, BioTel Heart, Biotronik, Cairdac, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Novo Nordisk, Philips, Pulse Biosciences; and unrelated to this work, has equity in Atraverse, DRS Vascular, Manual Surgical Sciences, Newpace, Nyra Medical, Soundcath, Surecor, and Vizaramed. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2024
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29. Impact of Left Atrial Posterior Wall Ablation During Pulsed-Field Ablation for Persistent Atrial Fibrillation.
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Turagam MK, Neuzil P, Schmidt B, Reichlin T, Neven K, Metzner A, Hansen J, Blaauw Y, Maury P, Arentz T, Sommer P, Anic A, Anselme F, Boveda S, Deneke T, Willems S, van der Voort P, Tilz R, Funasako M, Scherr D, Wakili R, Steven D, Kautzner J, Vijgen J, Jais P, Petru J, Chun J, Roten L, Füting A, Lemoine MD, Ruwald M, Mulder BA, Rollin A, Lehrmann H, Fink T, Jurisic Z, Chaumont C, Adelino R, Nentwich K, Gunawardene M, Ouss A, Heeger CH, Manninger M, Bohnen JE, Sultan A, Peichl P, Koopman P, Derval N, Kueffer T, Reinsch N, and Reddy VY
- Subjects
- Humans, Male, Female, Aged, Middle Aged, Retrospective Studies, Treatment Outcome, Registries, Atrial Fibrillation surgery, Catheter Ablation methods, Catheter Ablation adverse effects, Heart Atria surgery, Pulmonary Veins surgery
- Abstract
Background: Pulmonary vein isolation (PVI) alone is insufficient to treat many patients with persistent atrial fibrillation (PersAF). Adjunctive left atrial posterior wall (LAPW) ablation with thermal technologies has revealed lack of efficacy, perhaps limited by the difficulty in achieving lesion durability amid concerns of esophageal injury., Objectives: This study aims to compare the safety and effectiveness of PVI + LAPW ablation vs PVI in patients with PersAF using pulsed-field ablation (PFA)., Methods: In a retrospective analysis of the MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-approval Clinical Use of Pulsed Field Ablation) registry, we studied consecutive PersAF patients undergoing post-approval treatment with a pentaspline PFA catheter. The primary effectiveness outcome was freedom from any atrial arrhythmia of ≥30 seconds. Safety outcomes included the composite of acute and chronic major adverse events., Results: Of the 547 patients with PersAF who underwent PFA, 131 (24%) received adjunctive LAPW ablation. Compared to PVI-alone, patients receiving adjunctive LAPW ablation were younger (65 vs 67 years of age, P = 0.08), had a lower CHA
2 DS2 -VASc score (2.3 ± 1.6 vs 2.6 ± 1.6, P = 0.08), and were more likely to receive electroanatomical mapping (48.1% vs 39.0%, P = 0.07) and intracardiac echocardiography imaging (46.1% vs 17.1%, P < 0.001). The 1-year Kaplan-Meier estimate for freedom from atrial arrhythmias was not statistically different between groups in the full (PVI + LAPW: 66.4%; 95% CI: 57.6%-74.4% vs PVI: 73.1%; 95% CI: 68.5%-77.2%; P = 0.68) and propensity-matched cohorts (PVI + LAPW: 71.7% vs PVI: 68.5%; P = 0.34). There was also no significant difference in major adverse events between the groups (2.2% vs 1.4%, respectively, P = 0.51)., Conclusions: In patients with PersAF undergoing PFA, as compared to PVI-alone, adjunctive LAPW ablation did not improve freedom from atrial arrhythmia at 12 months., Competing Interests: Funding Support and Author Disclosures Boston Scientific provided a grant to help fund data collection but was not otherwise involved with study design or analysis nor did they have access to this manuscript before submission. Dr Turagam has received consulting fees from Biosense Webster; and has received speaker honorarium from Sanofi and Medtronic. Dr Neuzil has received grants from the Ministry of Health, Czech Republic, DRO (NHH, 00023884). Dr Schmidt has received speaker fees and research grants from Boston Scientific/Farapulse, Medtronic, Biosense Webster, and Abbott. Dr Reichlin has received grants from the Swiss National Science Foundation, the Swiss Heart Foundation, and the sitem insel support fund; has received speaker/consulting honoraria or travel support from Abbott/SJM, Bayer, Biosense Webster, Biotronik, Boston Scientific, Daiichi Sankyo, Medtronic, and Pfizer-BMS; and has received support for his institution’s fellowship program from Abbott/SJM, Biosense Webster, Biotronik, Boston Scientific, and Medtronic. Dr Metzner has received grants and fees from Farapulse. Dr Hansen has received speaker fees and grant support from Biosense Webster and Medtronic. Dr Blaauw has received grants from Medtronic and Atricure; and has received consulting fees from Abbott, Biosense Webster, and Boston Scientific. Dr Sommer has been a member of the advisory boards for Abbott, Biosense Webster, Boston Scientific, and Medtronic. Dr Anic has received consultant fees from Farapulse Inc, Boston Scientific Inc, Galaxy Medical Inc, Biosense Webster; and has performed contracted research for Farapulse Inc, Boston Scientific Inc, Galaxy Medical Inc, and Biosense Webster. Dr Anselme has received consulting fees from Boston Scientific, Medtronic, and Microport CRM. Dr Boveda has received consulting fees from Medtronic, Boston Scientific, Microport, Zoll, and BMS. Dr Deneke has received speaker honoraria from Galaxy Medical, Abbott, and Biotronik; has received consulting fees from Farapulse; and has served on a Clinical Events Committee for Boston Scientific. Dr Willems has received grants and personal fees from Abbott, Boston Scientific, and Medtronic; and has received personal fees from Boehringer Ingelheim, Brystol Myers Squibb, Bayer Vital, Accutus, Daiichi, and Farapulse Inc. Dr Tilz reports receiving consulting fees from Boston Scientific, Abbott Medical, Biotronik, Biosense Webster and speaker honorarium from Boston Scientific, Abbott Medical, Biotronik, Biosense Webster. Dr Scherr has received an educational grant from Farapulse Inc; and is a consultant For Boston Scientific Inc. Dr Wakili has received consulting fees and travel expenses from Boston Scientific and Biotronik; has received investigator-initiated funding for research projects (initiated by him) from Bristol-Myers Squibb, Pfizer, and Boston Scientific; and has received speaking honoraria from Boston Scientific, Biotronik, and Medtronic. Dr Scherr has received speaking fees from Pfizer, Bayer, Abbott, Johnson & Johnson, and Medtronic; has received grants from Abbott, Johnson & Johnson, and Boston Scientific; and has received consulting fees from Boston Scientific and Johnson & Johnson. Dr Kautzner has received personal fees from Bayer, Biosense Webster, Boehringer Ingelheim, Medtronic, and Abbott for participation in scientific advisory boards; and has received speaker honoraria from Bayer, Biosense Webster, Biotronik, Boehringer Ingelheim, CathVision, Medtronic, Mylan, Pfizer, ProMed, and Abbott. Dr Jais has received partial funding from IHU LIRYC ANR-10-IAHU-04; has received equity from Farapulse; and has received consulting fees and grants from Boston Scientific. Dr Chun has received speaker fees and research grants from Boston Scientific/Farapulse, Medtronic, Biosense Webster, and Abbott. Dr Roten has received speaker honoraria from Abbott/SJM; has received consulting honoraria from Medtronic; and has received research funding to the institution from Medtronic. Dr Lemoine has received grants from Farapulse. Dr Rollin has received grants from Farapulse. Dr Nentwich has received speaker fees from Farapulse, Inc. Dr Gunawardine has received grants from Farapulse Inc and Abbott. Dr Heeger has received travel grants and research grants from Boston Scientific, Lifetech, Biosense Webster, and Cardiofocus; has received speaker honoraria from Boston Scientific, Lifetech, Biosense Webster, Bayer, and Cardiofocus; and has received consulting fees from Medtronic, Lifetech, Boston Scientific, Biosense Webster, and Cardiofocus. Dr Manninger has received speaker fees from Bayer, Biosense Webster, Biotronik, Amomed, AOP Orphan, Boston Scientific, Daiichi Sankyo, and BMS/Pfizer; and has received grants from Biosense Webster and Abbott. Dr Sultan has received lecture and consulting honoraria from Medtronic, Abbott, and Bayer. Dr Derval has received consulting fees from Boston Scientific. Dr Reddy has received consulting fees (and equity – now divested) from Farapulse Inc; has received consulting fees from Boston Scientific Inc; and, unrelated to this manuscript, has served as a consultant for and has equity in Ablacon, Acutus Medical, Affera-Medtronic, Apama Medical-Boston Scientific, Anumana, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, CardioNXT/AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EPD-Philips, EP Frontiers, Epix Therapeutics-Medtronic, EpiEP, Eximo, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Kardium, Keystone Heart, Laminar, LuxMed, Medlumics, Middlepeak, Neutrace, Nuvera-Biosense Webster, Oracle Health, Restore Medical, Sirona Medical, SoundCath, Valcare; also unrelated to this work, he has received consulting fees from AtriAN, Biosense-Webster, BioTel Heart, Biotronik, Cairdac, Cardiofocus, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Philips, and Pulse Biosciences; and he has equity in Manual Surgical Sciences, Newpace, Nyra Medical, Surecor, and Vizaramed. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)- Published
- 2024
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30. Epicardial ventricular tachycardia ablation: safety and efficacy of access and ablation using low-iodine content.
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Müller J, Chakarov I, Halbfass P, Nentwich K, Berkovitz A, Sonne K, Barth S, Lehrmann H, and Deneke T
- Abstract
Background: Epicardial ablation has become an integral part of the treatment of ventricular tachycardias (VT). This study reports the safety of epicardial access as well as the efficacy of epicardial ablation of structural heart disease in a tertiary single-center experience., Methods: Between January 2016 and February 2022, consecutive patients undergoing an epicardial access for VT ablation were included. Different puncture techniques and occurrence of epicardial access-related complications as well as the safety of ablation using non-ionic 5% dextrose in water (D5W) compared to standard 0.9% normal saline (NS) irrigation were analyzed. VT recurrence rates during a mean follow-up of 37 ± 23 months were reported., Results: In total, 197 patients undergoing a total of 239 procedures were included (59.8 ± 15.3 years, 86% males). A total of 154 patients (78%) had non-ischemic cardiomyopathies with a mean LVEF of 37 ± 14. Anterior-oriented epicardial access was aimed for in all cases and was successful in 217 (91%) of all procedures, whereas access was achieved in 19 procedures (8%) only using an inferior oriented access and in three procedures (1%) using surgical access due to severe adhesions or anatomical requirements. Overall epicardial puncture-related complications occurred in 18 (8%) of all procedures with minor pericardial bleeding in nine, pericardial tamponade in one, pneumothorax in five, pneumopericardium in one, and abdominal puncture in two cases. Presence of adhesions could be identified as the only independent predictor of epicardial access-related complications. D5W was used in 79 cases and regular 0.9% saline in 117 procedures. No differences were seen regarding acute ablation success or complications. During follow-up, 47% of all patients were free from any VTs (56% D5W vs. 40% NS; log-rank p = 0.747) and 92% of clinical VTs (98% D5W vs. 91% NS; log-rank p = 0.139)., Conclusions: In this large single-centre experience, epicardial access and ablation were safe and feasible. Although long-term clinical VT recurrence rates were low, overall VT recurrences as well as mortality were high advocating for a highly experienced, interdisciplinary approach including intense management of underlying cardiac disease/heart failure. Routine usage of D5W was safe and associated with comparable short- or long-term clinical or overall VT freedom., (© 2024. The Author(s).)
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- 2024
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31. Clinical Outcomes by Sex After Pulsed Field Ablation of Atrial Fibrillation.
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Turagam MK, Neuzil P, Schmidt B, Reichlin T, Neven K, Metzner A, Hansen J, Blaauw Y, Maury P, Arentz T, Sommer P, Anic A, Anselme F, Boveda S, Deneke T, Willems S, van der Voort P, Tilz R, Funasako M, Scherr D, Wakili R, Steven D, Kautzner J, Vijgen J, Jais P, Petru J, Chun J, Roten L, Füting A, Lemoine MD, Ruwald M, Mulder BA, Rollin A, Lehrmann H, Fink T, Jurisic Z, Chaumont C, Adelino R, Nentwich K, Gunawardene M, Ouss A, Heeger CH, Manninger M, Bohnen JE, Sultan A, Peichl P, Koopman P, Derval N, Kueffer T, and Reddy VY
- Subjects
- Humans, Male, Female, Middle Aged, Aged, Adolescent, Retrospective Studies, Cohort Studies, Sex Factors, Treatment Outcome, Atrial Fibrillation drug therapy
- Abstract
Importance: Previous studies evaluating the association of patient sex with clinical outcomes using conventional thermal ablative modalities for atrial fibrillation (AF) such as radiofrequency or cryoablation are controversial due to mixed results. Pulsed field ablation (PFA) is a novel AF ablation energy modality that has demonstrated preferential myocardial tissue ablation with a unique safety profile., Objective: To compare sex differences in patients undergoing PFA for AF in the Multinational Survey on the Methods, Efficacy, and Safety on the Postapproval Clinical Use of Pulsed Field Ablation (MANIFEST-PF) registry., Design, Setting, and Participants: This was a retrospective cohort study of MANIFEST-PF registry data, which included consecutive patients undergoing postregulatory approval treatment with PFA to treat AF between March 2021 and May 2022 with a median follow-up of 1 year. MANIFEST-PF is a multinational, retrospectively analyzed, prospectively enrolled patient-level registry including 24 European centers. The study included all consecutive registry patients (age ≥18 years) who underwent first-ever PFA for paroxysmal or persistent AF., Exposure: PFA was performed on patients with AF. All patients underwent pulmonary vein isolation and additional ablation, which was performed at the discretion of the operator., Main Outcomes and Measures: The primary effectiveness outcome was freedom from clinically documented atrial arrhythmia for 30 seconds or longer after a 3-month blanking period. The primary safety outcome was the composite of acute (<7 days postprocedure) and chronic (>7 days) major adverse events (MAEs)., Results: Of 1568 patients (mean [SD] age, 64.5 [11.5] years; 1015 male [64.7%]) with AF who underwent PFA, female patients, as compared with male patients, were older (mean [SD] age, 68 [10] years vs 62 [12] years; P < .001), had more paroxysmal AF (70.2% [388 of 553] vs 62.4% [633 of 1015]; P = .002) but had fewer comorbidities such as coronary disease (9% [38 of 553] vs 15.9% [129 of 1015]; P < .001), heart failure (10.5% [58 of 553] vs 16.6% [168 of 1015]; P = .001), and sleep apnea (4.7% [18 of 553] vs 11.7% [84 of 1015]; P < .001). Pulmonary vein isolation was performed in 99.8% of female (552 of 553) and 98.9% of male (1004 of 1015; P = .90) patients. Additional ablation was performed in 22.4% of female (124 of 553) and 23.1% of male (235 of 1015; P = .79) patients. The 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was similar in male and female patients (79.0%; 95% CI, 76.3%-81.5% vs 76.3%; 95% CI, 72.5%-79.8%; P = .28). There was also no significant difference in acute major AEs between groups (male, 1.5% [16 of 1015] vs female, 2.5% [14 of 553]; P = .19)., Conclusion and Relevance: Results of this cohort study suggest that after PFA for AF, there were no significant sex differences in clinical effectiveness or safety events.
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- 2023
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32. Recurrent Atrial Fibrillation Ablation after Initial Successful Pulmonary Vein Isolation.
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Müller J, Nentwich K, Berkovitz A, Sonne K, Kozlova O, Barth S, Deacanu A, Waechter C, Halbfass P, Lehrmann H, and Deneke T
- Abstract
Background: Pulmonary vein isolation (PVI) is an effective treatment option for patients with symptomatic atrial fibrillation (AF). However, the electrical recovery of pulmonary veins (PVs) is the main trigger for AF recurrences. This study investigates the characteristics of patients admitted for redo AF ablation, the PV reconnection rates depending on previous ablation modalities and the impact of different ablation strategies for redo procedures., Methods: Consecutive patients undergoing first redo AF ablation were included. Patients were grouped according to the electrical recovery of at least one PV. The impacts of the technique for first AF ablation on PV reconnection rates and patients with and without PV reconnection were compared. Different ablation strategies for redo procedures were compared and its recurrence rates after a mean follow-up of 25 ± 20 months were investigated., Results: A total of 389 patients (68 ± 10 years; 57% male; 39% paroxysmal AF) underwent a first redo. The median time between the first and redo procedure was 40 ± 39 months. Radiofrequency was used in 278 patients, cryoballoon was used in 85 patients and surgical AF ablation was performed on 26 patients. In total, 325 patients (84%) had at least one PV reconnected, and the mean number of reconnected PVs was 2.0 ± 1.3, with significant differences between ablation approaches ( p for all = 0.002); this was mainly due to differences in the left inferior PV and right superior PV reconnections. The presence of PV reconnection during redo was not associated with better long-term success compared to completely isolated PVs (67% vs. 67%; log-rank p = 0.997). Overall, the different ablation strategies for redos were comparable regarding AF recurrences during follow-up ( p = 0.079), with the ablation approach having no impact in the case of left atrial low voltage or without., Conclusions: PV reconnections after initial successful PVI are common among all techniques of AF ablation. Long-term rhythm control off antiarrhythmic drugs was possible in 2/3 of all patients after the redo procedure; however, different ablation strategies with extra-PV trigger ablation did not improve long-term success. Patients with recurrent AF after PVI constitute a challenging group of patients.
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- 2023
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33. Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry.
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Turagam MK, Neuzil P, Schmidt B, Reichlin T, Neven K, Metzner A, Hansen J, Blaauw Y, Maury P, Arentz T, Sommer P, Anic A, Anselme F, Boveda S, Deneke T, Willems S, van der Voort P, Tilz R, Funasako M, Scherr D, Wakili R, Steven D, Kautzner J, Vijgen J, Jais P, Petru J, Chun J, Roten L, Füting A, Lemoine MD, Ruwald M, Mulder BA, Rollin A, Lehrmann H, Fink T, Jurisic Z, Chaumont C, Adeliño R, Nentwich K, Gunawardene M, Ouss A, Heeger CH, Manninger M, Bohnen JE, Sultan A, Peichl P, Koopman P, Derval N, Kueffer T, Rahe G, and Reddy VY
- Subjects
- Humans, Female, Middle Aged, Aged, Retrospective Studies, Stroke Volume, Ventricular Function, Left, Treatment Outcome, Registries, Recurrence, Atrial Fibrillation diagnosis, Atrial Fibrillation surgery, Atrial Fibrillation drug therapy, Atrial Flutter etiology, Catheter Ablation adverse effects, Catheter Ablation methods, Pulmonary Veins
- Abstract
Background: Pulsed field ablation is a novel nonthermal cardiac ablation modality using ultra-rapid electrical pulses to cause cell death by a mechanism of irreversible electroporation. Unlike the traditional ablation energy sources, pulsed field ablation has demonstrated significant preferentiality to myocardial tissue ablation, and thus avoids certain thermally mediated complications. However, its safety and effectiveness remain unknown in usual clinical care., Methods: MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a retrospective, multinational, patient-level registry wherein patients at each center were prospectively included in their respective center registries. The registry included all patients undergoing postapproval treatment with a multielectrode 5-spline pulsed field ablation catheter to treat atrial fibrillation (AF) between March 1, 2021, and May 30, 2022. The primary effectiveness outcome was freedom from clinical documented atrial arrhythmia (AF/atrial flutter/atrial tachycardia) of ≥30 seconds on the basis of electrocardiographic data after a 3-month blanking period (on or off antiarrhythmic drugs). Safety outcomes included the composite of acute (<7 days postprocedure) and latent (>7 days) major adverse events., Results: At 24 European centers (77 operators) pulsed field ablation was performed in 1568 patients with AF: age 64.5±11.5 years, female 35%, paroxysmal/persistent AF 65%/32%, CHA
2 DS2 -VASc 2.2±1.6, median left ventricular ejection fraction 60%, and left atrial diameter 42 mm. Pulmonary vein isolation was achieved in 99.2% of patients. After a median (interquartile range) follow-up of 367 (289-421) days, the 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was 78.1% (95% CI, 76.0%-80.0%); clinical effectiveness was more common in patients with paroxysmal AF versus persistent AF (81.6% versus 71.5%; P =0.001). Acute major adverse events occurred in 1.9% of patients., Conclusions: In this large observational registry of the postapproval clinical use of pulsed field technology to treat AF, catheter ablation using pulsed field energy was clinically effective in 78% of patients with AF., Competing Interests: Disclosures Dr Reddy reports receiving consulting fees (and equity—now divested) from Farapulse Inc. and is a consultant for Boston Scientific Inc; unrelated to this manuscript, Dr Reddy also serves as a consultant for and has equity in Ablacon, Acutus Medical, Affera-Medtronic, Apama Medical-Boston Scientific, Anumana, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, CardioNXT/ AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EPD-Philips, EP Frontiers, Epix Therapeutics-Medtronic, EpiEP, Eximo, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Kardium, Keystone Heart, LuxMed, Medlumics, Middlepeak, Neutrace, Nuvera-Biosense Webster, Oracle Health, Restore Medical, Sirona Medical, SoundCath, Valcare; unrelated to this work, has served as a consultant for AtriAN, Biosense-Webster, BioTel Heart, Biotronik, Cairdac, Cardiofocus, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Philips, Pulse Biosciences; and has equity in Manual Surgical Sciences, Newpace, Nyra Medical, Surecor, and Vizaramed. Dr Schmidt reports receiving speaker’s fees and research grants from Boston Scientific/Farapulse, Medtronic, Biosense Webster, and Abbott. Dr Reichlin reports research grants from the Swiss National Science Foundation, the Swiss Heart Foundation, and the sitem insel Support Fund. Speaker/consulting honoraria or travel support from Abbott/SJM, Bayer, Biosense Webster, Biotronik, Boston Scientific, Daiichi Sankyo, Medtronic, and Pfizer-BMS. Support for his institution’s fellowship programme from Abbott/SJM, Biosense Webster, Biotronik, Boston Scientific, and Medtronic. Dr Roten reports receiving speaker honoraria from Abbott/SJM, consulting honoraria from Medtronic, and research funding to the institution from Medtronic. Dr Neven reports speaker’s fees from Farapulse, Inc. Dr Metzner reports research grant and fees from Farapulse. Dr Rollin reports receiving research grant from Farapulse. Dr Lemoine reports receiving research grant from Farapulse. Dr Hansen reports receiving speaker fees and grant support from Biosense Webster, and Medtronic. Dr Blaauw reports receiving research grants from Medtronic and Atricure and consulting fees from Abbott, Biosense Webster, Boston Scientific. Dr Sommer reports member of the advisory board for Abbott, Biosense Webster, Boston Scientific, and Medtronic. Dr Anic reports receiving consultant fees from Farapulse Inc., Boston Scientific Inc., Galaxy Medical Inc., Biosense Webster, and performs contracted research for Farapulse Inc., Boston Scientific Inc., Galaxy Medical Inc., and Biosense Webster. Dr Anselme reports receiving consulting fees from Boston Scientific, Medtronic, and Microport CRM. Dr Boveda reports receiving consulting fees from Medtronic, Boston Scientific, Microport, Zoll, and BMS. Dr Deneke reports receiving speaker honoraria from Galaxy Medical, Abbott, and Biotronik, being a consultant to Farapulse, and serving on a Clinical Events Committee for Boston Scientific. Dr Willems reports receiving grants and personal fees from Abbott, Boston Scientific, Medtronic, and personal fees from Boehringer Ingelheim, Brystol Myers Squibb, Bayer Vital, Accutus, Daiichi, and Farapulse Inc. Dr Gunawardene reports grants from Farapulse Inc. and Abbott. Dr Tilz reports receiving consulting fees from Boston Scientific, Abbott Medical, Biotronik, Biosense Webster and speaker honorarium from Boston Scientific, Abbott Medical, Biotronik, and Biosense Webster. Dr Heeger received travel grants and research grants by Boston Scientific, Lifetech, Biosense Webster, and Cardiofocus and Speaker´s Honoraria from Boston Scientific, Lifetech. Biosense Webster, Bayer, and Cardiofocus. He is a consultant of Medtronic, Lifetech, Boston Scientific, Biosense Webster, and Cardiofocus. Dr Scheer reports receiving an educational grant from Farapulse Inc. and is a consultant for Boston Scientific Inc. Dr Wakili reports receiving consultant fees and travel expenses from Boston Scientific and Biotronik; investigator-initiated funding for research projects (initiated by him) from Bristol-Myers Squibb, Pfizer, and Boston Scientific; and speaking honoraria from Boston Scientific, Biotronik, and Medtronic. Dr Steven reports receiving speaking fees from Pfizer, Bayer, Abbott, Johnson & Johnson, and Medtronic; grants from Abbott, Johnson & Johnson, and Boston Scientific; and consulting fees from Boston Scientific and Johnson & Johnson. Dr Sultan reports receiving lecture and consulting honoraria from Medtronic, Abbott, and Bayer. Dr Kautzner reports personal fees from Bayer, Biosense Webster, Boehringer Ingelheim, Medtronic, and Abbott for participation in scientific advisory boards, and has received speaker honoraria from Bayer, Biosense Webster, Biotronik, Boehringer Ingelheim, CathVision, Medtronic, Mylan, Pfizer, ProMed, and Abbott. Dr Jais reports receiving equity from Farapulse and consulting fees and grant from Boston Scientific. Dr Derval reports receiving consulting fees from Boston scientific. Dr Chun reports receiving speaker’s fees and research grants from Boston Scientific/Farapulse, Medtronic, Biosense Webster, and Abbott. Dr Neuzil reports receiving grants from the Ministry of Health, Czech Republic, DRO (NHH, 00023884). Dr Manninger reports receiving speaker fees from Bayer, Biosense Webster, Biotronik, Amomed, AOP Orphan, Boston Scientific, Daiichi Sankyo, BMS/Pfizer and research grants from Biosense Webster and Abbott. All remaining authors have declared no conflict of interest.- Published
- 2023
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34. Adverse Prognosis of Patients With Septal Substrate After VT Ablation Due to Electrical Storm.
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Mueller J, Chakarov I, Halbfass P, Nentwich K, Ene E, Berkovitz A, Sonne K, Barth S, Waechter C, Behnes M, Akin I, Fodor S, Lehmkuhl L, and Deneke T
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- Humans, Male, Middle Aged, Aged, Female, Prognosis, Arrhythmias, Cardiac etiology, Recurrence, Tachycardia, Ventricular, Myocardial Ischemia complications, Catheter Ablation adverse effects
- Abstract
Background: Data about ventricular tachycardia (VT) ablation in patients with electrical storm (ES) is limited., Objectives: This study sought to compare the prognostic outcome of patients undergoing VT ablation after ES with and without a septal substrate., Methods: In this large single-center study, consecutive patients presenting with ES and undergoing VT ablation from June 2018 to April 2021 were included. Patients with septal substrate were compared with patients without septal substrate regarding endpoints of cardiovascular mortality, VT recurrences, recurrences of the clinical VT, and rehospitalization rates., Results: A total of 107 patients undergoing a first VT ablation because of electrical storm (ES) were included (age 65 ± 13 years, 86% male, 45% ischemic cardiomyopathy). Major complications occurred in 11% of all patients with increased postinterventional third-degree atrioventricular blocks among patients with septal substrate (9% vs 0%; P = 0.063). Partial ablation successes were similar (95% with a septal substrate vs 100% without a septal substrate; P = 0.251). Complete ablation success was achieved in 63% with a septal substrate and in 87% without a septal substrate (P = 0.004). After a median 22 months of follow-up, patients with septal substrate died significantly more often from cardiovascular causes (26% vs 7%; log-rank P = 0.018). In univariate analysis cardiovascular mortality for ES patients with septal substrate was 4.1-fold higher (HR: 4.192; CI: 1.194-14.719; P = 0.025). Independent predictors of adverse outcome in multivariable regression analysis were presence of septal substrate (HR: 5.723; P = 0.025) and increased age (HR: 1.104; P = 0.003). Recurrences of any ventricular arrhythmia (67% vs 56%; log rank P = 0.554) and rehospitalization rates (80% vs 66%; log rank P = 0.515) were similar between groups. Recurrences of clinical VT were similar (7% vs 2%; P = 0.252)., Conclusions: Presence of a septal substrate is associated with adverse long-term cardiovascular mortality in patients admitted for VT ablation after ES. Despite decreased acute ablation successes in these patients, VT recurrence rates were similar to those without a septal substrate during follow-up., Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2023
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35. Acute oesophageal safety and long-term follow-up of AI-guided high-power short-duration with 50 W for atrial fibrillation ablation.
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Müller J, Nentwich K, Berkovitz A, Ene E, Sonne K, Zhuravlev V, Chakarov I, Barth S, Waechter C, Behnes M, Halbfass P, and Deneke T
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- Humans, Male, Female, Follow-Up Studies, Treatment Outcome, Esophagus surgery, Artificial Intelligence, Recurrence, Atrial Fibrillation diagnosis, Atrial Fibrillation surgery, Atrial Fibrillation etiology, Catheter Ablation adverse effects, Catheter Ablation methods, Pulmonary Veins surgery
- Abstract
Aims: Pulmonary vein isolation using radiofrequency ablation is an effective treatment option for patients with symptomatic atrial fibrillation (AF). Application of high power over a short period of time (HPSD) is reported to create more efficient lesions and may prevent collateral thermal oesophageal injury. This study aims to compare efficacy and safety of two different HPSD ablation approaches using different ablation index settings., Methods and Results: Consecutive patients undergoing AF ablation with HPSD (50 W; ablation index-guided) using the ThermoCool SmartTouch SF catheter were included. Patients were grouped by ablation protocol: ablation with target ablation index (AI) of 400 on the anterior left atrial wall vs. 300 at the posterior left atrial wall (AI 400/300) or AI 450/350 was performed upon the operator's preference and compared. Peri-procedural parameters and complications were recorded, and incidences of endoscopically detected thermal oesophageal lesions (EDEL) analysed. Recurrence rates after a mean follow-up of 25 ± 7 months and reconnection patterns in patients undergoing redo procedures were investigated. A total of 795 patients (67 ± 10 years; 58% male; 48% paroxysmal AF) underwent a first AF ablation with HPSD (211 in group AI 400/300 and 584 in group 450/350). Median procedure time was 82.9 ± 24.6 min with longer ablation times in patients with target AI 400/300 due to higher intraprocedural reconnection rates, increased box lesions, and additional right atrial isthmus ablations. EDEL rates among target AI 400/300 procedures were significantly lower (3% vs. 7%; P = 0.019). Correspondingly, AI 450/350 was the strongest independent predictor of post-ablation EDEL (OR 4.799, CI 1.427-16.138, P = 0.011). Twelve-month (76% vs. 76%; P = 0.892) and long-term ablation single procedure success (68% vs. 71%; log-rank P = 0.452) after a mean of 25 ± 7 months were comparable among both target AI groups; however, long-term success was significantly higher for paroxysmal AF compared to persistent AF (12 months: 80% vs. 72%; P = 0.010; end of follow-up: 76% vs. 65%; log-rank P = 0.001). One hundred three patients (16%) underwent a redo procedure during follow-up documented comparable pulmonary vein (PV) reconnection among groups. Multivariate predictors of AF recurrence were age, left atrium (LA) size, persistent AF, and extra-PV ablation targets., Conclusion: High-power short-duration AF ablation with target AI of 400 for non-posterior wall and 300 for posterior wall lesions resulted in comparable long-term results compared to higher AI (450/350) ablations with significantly lower risk for thermal oesophageal lesions. Older age, larger LA size, persistent AF, and extra-PV ablation targets were identified in a multivariate analysis as independent risk factors for recurrences of atrial arrhythmias., Competing Interests: Conflict of interest: None declared., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2023
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36. Electrical Storm Has Worse Prognosis Compared to Sustained Ventricular Tachycardia after VT Ablation.
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Mueller J, Chakarov I, Halbfass P, Nentwich K, Ene E, Berkovitz A, Sonne K, Barth S, Waechter C, Schupp T, Behnes M, Akin I, and Deneke T
- Abstract
Background: Electrical storm (ES) represents a serious heart rhythm disorder. This study investigates the impact of ES on acute ablation success and long-term outcomes after VT ablation compared to non-ES patients., Methods: In this large single-centre study, patients presenting with ES and undergoing VT ablation from June 2018 to April 2021 were compared to patients undergoing VT ablation due to ventricular tachyarrhythmias but without ES. The primary prognostic outcome was VT recurrence, and secondary endpoints were rehospitalization rates and cardiovascular mortality, all after a median follow-up of 22 months., Results: A total of 311 patients underwent a first VT ablation due to ventricular tachyarrhythmias and were included (63 ± 14 years; 86% male). Of these, 108 presented with ES. In the ES cohort, dilated cardiomyopathy as underlying heart disease was significantly higher ( p = 0.008). Major complications were equal across both groups (all p > 0.05). Ablation of the clinical VT was achieved in 94% of all patients ( p > 0.05). Noninducibility of any VT was achieved in 91% without ES and in 76% with ES ( p = 0.001). Patients with ES revealed increased VT recurrence rates during follow-up (65% vs. 40%; log rank p = 0.001; HR 1.841, 95% CI 1.289-2.628; p = 0.001). Furthermore, ES patients suffered from increased rehospitalization rates (73% vs. 48%; log rank p = 0.001; HR 1.948, 95% CI 1.415-2.682; p = 0.001) and cardiovascular mortality (18% vs. 9%; log rank p = 0.045; HR 1.948, 95% CI 1.004-3.780; p = 0.049). After multivariable adjustment, ES was a strong independent predictor of VT recurrence and rehospitalization rates, but not for mortality. In a propensity score-matched cohort, patients with ES still had a higher risk of VT recurrences and rehospitalizations compared to non-ES patients., Conclusions: VT ablation in patients with ES is challenging and these patients reveal the highest risk for recurrent VTs, rehospitalization and cardiovascular mortality. These patients need close follow-ups and optimal guideline-directed therapy.
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- 2023
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37. Radiofrequency ablation of atrial fibrillation-50 W or 90 W?
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Mueller J, Nentwich K, Ene E, Berkovitz A, Sonne K, Chakarov I, Barth S, Waechter C, Behnes M, Akin I, Halbfass P, and Deneke T
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- Humans, Male, Female, Retrospective Studies, Recurrence, Treatment Outcome, Atrial Fibrillation diagnosis, Atrial Fibrillation surgery, Pulmonary Veins surgery, Catheter Ablation adverse effects, Catheter Ablation methods
- Abstract
Background: This study sought to evaluate the short and midterm efficacy and safety of the novel very high power very short duration (vHPvSD) 90 W approach compared to HPSD 50 W for atrial fibrillation (AF) ablation as well as reconnection patterns of 90 W ablations., Methods and Results: Consecutive patients undergoing first AF ablation with vHPvSD (90 W; predefined ablation time of 3 s for posterior wall ablation and 4 s for anterior wall ablation) were compared to patients using HPSD (50 W; ablation index-guided; AI 350 for posterior wall ablation, AI 450 for anterior wall ablation) retrospectively. A total of 84 patients (67.1 ± 9.8 years; 58% male; 47% paroxysmal AF) were included (42 with 90 W, 42 with 50 W) out of a propensity score-matched cohort. 90 W ablations revealed shorter ablation times (10.5 ± 6.7 min vs. 17.4 ± 9.9 min; p = .001). No major complication occurred. 90 W ablations revealed lower first pass PVI rates (40% vs. 62%; p = .049) and higher AF recurrences during blanking period (38% vs. 12%; p = .007). After 12 months, both ablation approaches revealed comparable midterm outcomes (62% vs. 70%; log-rank p = .452). In a multivariable Cox regression model, persistent AF (hazard ratio [HR]: 1.442, 95% confidence interval [CI]: 1.035-2.010, p = .031) and increased procedural duration (HR: 1.011, 95% CI: 1.005-1.017, p = .001) were identified as independent predictors of AF recurrence during follow-up., Conclusions: AF ablation using 90 W vHPvSD reveals a similar safety profile compared to 50 W ablation with shorter ablation times. However, vHPvSD ablation was associated with lower rates of first-pass isolations and increased AF recurrences during the blanking period. After 12 months, 90 W revealed comparable efficacy results to 50 W ablations in a nonrandomized, propensity-matched comparison., (© 2022 Wiley Periodicals LLC.)
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- 2022
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38. Empirical superior vena cava isolation in patients undergoing repeat catheter ablation procedure after recurrence of atrial fibrillation.
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Simu G, Deneke T, Ene E, Nentwich K, Berkovitz A, Sonne K, Halbfass P, Arvaniti E, Waechter C, and Müller J
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- Humans, Male, Female, Vena Cava, Superior surgery, Recurrence, Treatment Outcome, Atrial Fibrillation surgery, Catheter Ablation methods, Pulmonary Veins surgery
- Abstract
Background: Although the ectopic foci responsible for initiating atrial fibrillation (AF) are usually located in the pulmonary veins (PVs), non-PV sources may initiate AF in approximately 11% of unselected patients with paroxysmal or persistent AF. The superior vena cava (SVC) is one of the most frequent non-PV origins for initiating AF. This study aims to investigate the effect of empirical SVC isolation in redo AF ablation procedures., Methods: Consecutive patients undergoing redo AF ablation procedures using a high-power short-duration protocol (HPSD) (50 W; ablation index guided; target AI 350 for posterior wall ablation, AI 450 for anterior wall ablation; CARTO 3 mapping system) were included. Patients with SVC isolation were compared to patients without SVC isolation. Periprocedural parameters and complications were recorded and analyzed. Short-term endpoints included intrahospital AF recurrence, midterm endpoint AF freedom after 3 months, and long-term endpoint AF freedom after 12 months., Results: A total of 276 patients underwent repeat ablation for recurrent AF (67 ± 10 years; 57% male; 31.5% paroxysmal AF). The patients were divided into two groups: redo procedures with SVC isolation vs redo procedure without SVC isolation. Additional LA substrate modification was done based on intraprocedural voltage maps. Baseline characteristics did not differ significantly between the two groups. Median procedure time was 85.4 ± 27.1 min with ablation times of 14.0 ± 8.5 min. Intrahospital AF recurrence occurred in 32 patients (12%) with no difference among both groups: 17 patients (13%) SVC vs 15 patients (10%) No-SVC; p = 0.416. At 3-month follow-up, 47 (17%) presented an AF recurrence during the blanking period: 25 patients (19%) SVC vs 22 patients (15%) No-SVC; p = 0.304). After 12 months, 202 (73%) of all patients were in stable sinus rhythm with no significant difference between the two groups: 93 patients (73%) SVC vs 109 patients (74%) No-SVC; p = 0.853). No significant differences were noted when dividing the patients in paroxysmal or persistent AF with and without SVC isolation., Conclusions: In our series of repeat AF ablation procedures, the addition of empirical SVC isolation to Re-PVI and LA substrate modification did not influence AF recurrence rates. This strategy can however be safe and useful in patients in whom SVC is identified as a trigger of AF., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2022
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39. Optimal cut-off value for endocardial bipolar voltage mapping using a multipoint mapping catheter to characterize the scar regions described in cardio-CT with myocardial thinning.
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Ene E, Halbfaß P, Nentwich K, Sonne K, Berkovitz A, Cochet H, Jais P, Lehmkuhl L, Foldyna B, and Deneke T
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- Catheters, Cicatrix diagnostic imaging, Cicatrix etiology, Endocardium, Humans, Male, Tomography, X-Ray Computed, Catheter Ablation, Tachycardia, Ventricular diagnostic imaging, Tachycardia, Ventricular etiology
- Abstract
Introduction: To investigate whether the current standard voltage cut-off of <0.5 for dense scar definition on endocardial bipolar voltage mapping (EBVM), using a high-resolution multipoint mapping catheter with microelectrodes (HRMMC), correctly identifies the actual scar area described on CT with myocardial thinning (CT MT)., Methods: Forty patients (39 men; 67.0 ± 9.0 y/o) with a history of transmural myocardial infarction (mean time interval since MI 15.0 ± 7.9 years) and sustained ventricular tachycardia (VT) were consecutively enrolled. A CT MT was performed in each patient before VT ablation. The CT MT 3D anatomical model, including MT layers, was merged with the 3D electroanatomical and EBVM. Different predefined cut-off settings for scar definition on EBVM were used to identify the optimal ones, which showed the best overlap in terms of scar area with the different MT layers., Results: A cut-off value of <0.2 mV demonstrated the best correlation in terms of scar area with the 2 mm thinning on CT MT (p = .04) and a cut-off of <1 mV best overlapped with the 5 mm thinning (p = .003). The currently used <0.5 mV cut-off for scar definition on EBVM proved to be the best area correlation with 3 mm thinning (p = .0002)., Conclusion: In order to better identify the real extent of scar areas after transmural MI as described on preprocedural CT MT, higher cut-off values for scar definition should be applied if the EBVM is performed using a HRMMC., (© 2022 Wiley Periodicals LLC.)
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- 2022
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40. Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF).
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Ekanem E, Reddy VY, Schmidt B, Reichlin T, Neven K, Metzner A, Hansen J, Blaauw Y, Maury P, Arentz T, Sommer P, Anic A, Anselme F, Boveda S, Deneke T, Willems S, van der Voort P, Tilz R, Funasako M, Scherr D, Wakili R, Steven D, Kautzner J, Vijgen J, Jais P, Petru J, Chun J, Roten L, Füting A, Rillig A, Mulder BA, Johannessen A, Rollin A, Lehrmann H, Sohns C, Jurisic Z, Savoure A, Combes S, Nentwich K, Gunawardene M, Ouss A, Kirstein B, Manninger M, Bohnen JE, Sultan A, Peichl P, Koopman P, Derval N, Turagam MK, and Neuzil P
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- Adult, Aged, Aged, 80 and over, Female, Humans, Middle Aged, Retrospective Studies, Treatment Outcome, Young Adult, Atrial Fibrillation diagnosis, Atrial Fibrillation etiology, Atrial Fibrillation surgery, Catheter Ablation methods, Pulmonary Veins surgery, Stroke etiology
- Abstract
Aims: Pulsed field ablation (PFA) is a novel atrial fibrillation (AF) ablation modality that has demonstrated preferential tissue ablation, including no oesophageal damage, in first-in-human clinical trials. In the MANIFEST-PF survey, we investigated the 'real world' performance of the only approved PFA catheter, including acute effectiveness and safety-in particular, rare oesophageal effects and other unforeseen PFA-related complications., Methods and Results: This retrospective survey included all 24 clinical centres using the pentaspline PFA catheter after regulatory approval. Institution-level data were obtained on patient characteristics, procedure parameters, acute efficacy, and adverse events. With an average of 73 patients treated per centre (range 7-291), full cohort included 1758 patients: mean age 61.6 years (range 19-92), female 34%, first-time ablation 94%, paroxysmal/persistent AF 58/35%. Most procedures employed deep sedation without intubation (82.1%), and 15.1% were discharged same day. Pulmonary vein isolation (PVI) was successful in 99.9% (range 98.9-100%). Procedure time was 65 min (38-215). There were no oesophageal complications or phrenic nerve injuries persisting past hospital discharge. Major complications (1.6%) were pericardial tamponade (0.97%) and stroke (0.4%); one stroke resulted in death (0.06%). Minor complications (3.9%) were primarily vascular (3.3%), but also included transient phrenic nerve paresis (0.46%), and TIA (0.11%). Rare complications included coronary artery spasm, haemoptysis, and dry cough persistent for 6 weeks (0.06% each)., Conclusion: In a large cohort of unselected patients, PFA was efficacious for PVI, and expressed a safety profile consistent with preferential tissue ablation. However, the frequency of 'generic' catheter complications (tamponade, stroke) underscores the need for improvement., Competing Interests: Conflict of interest: V.Y.R. reports receiving consulting fees and equity (stock) from Farapulse Inc. and is a consultant for Boston Scientific Inc.; he also has additional disclosures unrelated to this manuscript that are listed in the Supplementary material online. B.S. reports receiving speaker’s fees and research grants from Boston Scientific/Farapulse, Medtronic, Biosense Webster, and Abbott. T.R. reports research grants from the Swiss National Science Foundation, the Swiss Heart Foundation, and the sitem insel support fund. Speaker/consulting honoraria or travel support from Abbott/SJM, Bayer, Biosense Webster, Biotronik, Boston Scientific, Daiichi Sankyo, Medtronic, and Pfizer-BMS. Support for his institution’s fellowship programme from Abbott/SJM, Biosense Webster, Biotronik, Boston Scientific, and Medtronic. L.R. reports receiving speaker honoraria from Abbott/SJM and consulting honoraria from Medtronic. K.N. reports speaker’s Fees from Farapulse, Inc. A.M. reports research grant and fees from Farapulse. A.R. reports receiving research grant from Farapulse. J.H. reports receiving speaker fees and grant support from Biosense Webster and Medtronic. Y.B.: reports receiving Research grant from Medtronic and Atricure and consulting fees from Abbott, Biosense Webster, Boston Scientific. P.S. reports member of the advisory board for Abbott, Biosense Webster, Boston Scientific, and Medtronic. C.S. reports receiving modest honoraria from Medtronic. A.A. reports receiving consultant fees from Farapulse Inc., Boston Scientific Inc., Galaxy Medical Inc., Biosense Webster, and performs contracted research for Farapulse Inc., Boston Scientific Inc., Galaxy Medical Inc., Biosense Webster. F.A. reports receiving consulting fees from Boston Scientific, Medtronic and Microport CRM. S.B. reports receiving consulting fees for Medtronic, Boston Scientific, Microport, Zoll, and BMS. T.D. reports receiving speaker honoraria from Galaxy Medical, Abbott and Biotronik, being a consultant to Farapulse, and serving on a Clinical Events Committee for Boston Scientific. S.W. reports receiving grants and personal fees from Abbott, Boston Scientific, Medtronic, and personal fees from Boehringer Ingelheim, Brystol Myers Squibb, Bayer Vital, Accutus, Daiichi, Farapulse Inc. M.G. reports grant from Farapulse Inc. and Abbott. R.T. reports receiving consulting fees from Boston Scientific, Abbot Medical, Biotronik, and speakers honorarium from Boston Scientific, Abbot Medical, Biotronik, Biosense Webster. B.K. reports receiving Travel and Congress Sponsoring from Biotronik, Abbott, Impulse Dynamics, DGK AG EP, EHRA, Pfizer; she also received fellowship sponsoring from Johnson & Johnson, Boston Scientific and Lecture Honorary from Biotronik, Impulse Dynamics, C.T.I. GmbH, Doctrina Med. D.S. reports receiving an educational grant from Farapulse Inc., and is a consultant For Boston Scientific Inc. R.W. reports receiving consultant fees and travel expenses from Boston Scientific and Biotronik; investigator-initiated funding for research projects (initiated by him) from Bristol-Myers Squibb, Pfizer, and Boston Scientific; and speaking honoraria from Boston Scientific, Biotronik, and Medtronic. D.S. reports receiving speaking fees from Pfizer, Bayer, Abbott, Johnson & Johnson, and Medtronic; grant from Abbott, Johnson & Johnson, and Boston Scientific; and consulting fees from Boston Scientific and Johnson & Johnson. A.S. reports receiving lecture and consulting honoraria from Medtronic, Abbott, and Bayer. J.K. reports personal fees from Bayer, Biosense Webster, Boehringer Ingelheim, Medtronic, and Abbott for participation in scientific advisory boards, and has received speaker honoraria from Bayer, Biosense Webster, Biotronik, Boehringer Ingelheim, CathVision, Medtronic, Mylan, Pfizer, ProMed, and Abbott. P.J. reports receiving equity from Farapulse and consulting fees and grant from Boston Scientific. N.D. reports receiving consulting fees from Boston scientific. J.C. reports receiving speaker’s fees and research grants from Boston Scientific/Farapulse, Medtronic, Biosense Webster, and Abbott. P.N. reports receiving grant from the Ministry of Health, Czech Republic, DRO (NHH, 00023884). All the remaining authors have declared no conflict of interest., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2022
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41. Acute oesophageal safety of high-power short duration with 50 W for atrial fibrillation ablation.
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Müller J, Berkovitz A, Halbfass P, Nentwich K, Ene E, Sonne K, Simu G, Chakarov I, Barth S, Waechter C, Behnes M, Akin I, and Deneke T
- Subjects
- Esophagoscopy adverse effects, Esophagus injuries, Female, Humans, Male, Recurrence, Treatment Outcome, Atrial Fibrillation diagnosis, Atrial Fibrillation surgery, Burns epidemiology, Catheter Ablation adverse effects, Catheter Ablation methods, Pulmonary Veins surgery
- Abstract
Aims: Pulmonary vein isolation (PVI) using radiofrequency (RF) ablation is an effective treatment option for patients with atrial fibrillation (AF). This study aims to investigate the safety of high-power short duration (HPSD) with emphasis on oesophageal lesions after PVI., Methods and Results: Consecutive patients undergoing AF ablation with HPSD (50 W; ablation index (AI)-guided; target AI 350 for posterior wall ablation, AI 450 for anterior wall ablation) using the ThermoCool SmartTouch SF catheter were included. Patients underwent post-ablation oesophageal endoscopy to detect and categorize thermal oesophageal injury (EDEL). Occurrence and risk factors of oesophageal lesions and perforating complications were analysed. A total of 1033 patients underwent AF ablation with HPSD. Of them, 953 patients (67.6 ± 9.6 years; 58% male; 43% paroxysmal AF; 68% first PVI) underwent post-procedural oesophageal endoscopy and were included in further analyses. Median procedure time was 82.8 ± 24.4 min with ablation times of 16.1 ± 9.2 min. Thermal oesophageal injury was detected in 58 patients (6%) (n = 29 Category 1 erosion, n = 29 Category 2 ulcerous). One patient developed oesophageal perforation (redo, 4th AF ablation). No patient died. Using multivariable regression models, increased total ablation time [odds ratio (OR) 1.029, P = 0.010] and history of stroke (OR 2.619, P = 0.033) were associated with increased incidence of EDEL after AF ablation, whereas increased body mass index was protective (OR 0.980, P = 0.022)., Conclusion: Thermal oesophageal lesions occur in 6% of HPSD AF ablations. The risk for development of perforating complications seems to be low. Incidence of atrio-oesophageal fistula (0.1%) is comparable to other reported series about RF ablation approaches., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2022. For permissions, please email: journals.permissions@oup.com.)
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- 2022
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42. Long-Term Outcomes after Catheter Ablation of Ventricular Tachycardia in Dilated vs. Ischemic Cardiomyopathy.
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Chakarov I, Mueller J, Ene E, Berkovitz A, Sonne K, Nentwich K, Schupp T, Behnes M, and Deneke T
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Ischemic (ICM) and dilated cardiomyopathy (DCM) represent the two main underlying heart diseases in patients referred for catheter ablation of ventricular tachycardia (VT). While VT ablation in ischemic cardiomyopathy is relatively well-studied, data in patients with DCM are still scarce. The study aimed to compare the acute and long-term outcomes in patients with ICM and DCM who underwent VT ablation at a high-volume center. Consecutive patients who underwent VT ablation from April 2018 to April 2021 were included retrospectively. Patients with ischemic cardiomyopathy were compared to those with dilated cardiomyopathy. The primary endpoint was rate of VT recurrences, the secondary endpoints included overall mortality, rehospitalization because of cardiac condition (VT, acute heart failure, acute myocardial infarction, heart transplantation or implantation of left ventricular assisting device), and major adverse cardiac events (MACE) at long-term follow-up. A total of 225 patients admitted for first VT ablation were included. A total of 156 patients (69%) revealed ICM and 69 (31%) DCM. After a mean follow-up of 22 months, the primary endpoint of VT recurrence occurred significantly more often in the patients with dilated cardiomyopathy (ICM n = 47; 37% vs. DCM n = 34; 64%; p = 0.001). In regard to the secondary endpoint of overall mortality, there was no difference between the two patient cohorts (DCM n = 9; 15% vs. ICM n = 22; 16%; p = 0.677); the patients with DCM showed significantly higher rehospitalization rates due to cardiac conditions (75% vs. 59%; p = 0.038) and more frequent MACE (68% vs. 52%; p = 0.036). In a Cox regression model, electrical storm at admission was shown to be a predictor for VT recurrence after successful catheter ablation (HR = 1.942: 95% CI 1.237-3.050; p = 0.004), while the ablation of every induced VT morphology during the procedure (HR = 0.522; 95% CI = 0.307-0.885; p = 0.016) contributed to a positive long-term outcome. DCM is associated with a higher risk of VT recurrence after catheter ablation compared to ICM. Furthermore, patients with DCM are more frequent re-hospitalized in the majority of cases due the VT recurrence. There is no difference in the long-term mortality between the two cohorts.
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- 2022
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43. Efficacy and safety of high-power short duration atrial fibrillation ablation in elderly patients.
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Müller J, Nentwich K, Berkovitz A, Ene E, Sonne K, Chakarov I, Barth S, Waechter C, Lüsebrink U, Behnes M, Akin I, and Deneke T
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- Aged, Aged, 80 and over, Female, Humans, Male, Recurrence, Retrospective Studies, Treatment Outcome, Atrial Fibrillation diagnosis, Atrial Fibrillation etiology, Atrial Fibrillation surgery, Catheter Ablation adverse effects, Catheter Ablation methods, Pulmonary Veins surgery
- Abstract
Introduction: Data about atrial fibrillation (AF) ablation using high-power short duration (HPSD) radiofrequency ablation in the elderly population is still scarce. The aim of our study was to investigate the efficacy and safety of HPSD ablation in patients over 75 years compared to younger patients., Methods: Consecutive patients older than 75 years with paroxysmal or persistent AF undergoing a first-time AF ablation using 50 W HPSD ablation approach were analyzed in this retrospective observational analysis and compared to a control group <75 years. Short-term endpoints included intraprocedural reconnection of at least one pulmonary vein (PV) and intrahospital and AF recurrence during 3 months blanking period, as well as a long-term endpoint of freedom from atrial arrhythmias of antiarrhythmic drugs after 12 months., Results: A total of 540 patients underwent a first AF ablation with HPSD (66 ± 10 years; 58% male; 47% paroxysmal AF). Mean age was 78 ± 2.4 and 63 ± 6.3 years (p < .001), respectively. Elderly patients were significantly more often women (p < .001). The procedure, fluoroscopy, and ablation were comparable. Elderly patients revealed significantly more often extra-PV low-voltage areas requiring additional left atrial ablations (p < .001). Overall complication rates were low; however, elderly patients revealed higher major complication rates mainly due to unmasking sick sinus syndrome (p = .003). Freedom from arrhythmia recurrences was comparable (68% vs. 76%, log-rank p = .087). Only in the subgroup of paroxysmal AF, AF recurrences were more common after 12 months (69% vs. 82%; log-rank p = .040; hazard ratio: 1.462, p = .044) in the elderly patients. In multivariable Cox regression analysis of the whole cohort persistent AF, female gender, diabetes mellitus and presence of left atrium low-voltage areas, but not age >75 years were associated with AF recurrences., Conclusion: HPSD AF ablation of patients >75 years in experienced centers is safe and effective. Therefore, age alone should not be the reason to withhold AF ablation from vital elderly patients due to only a slightly worse outcome and safety profile. In paroxysmal AF, elderly patients have more recurrences compared to the younger control group., (© 2022 Wiley Periodicals LLC.)
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44. Case report: Epicardial ligation of the left atrial appendage in a patient with an inaccessible left atrial cavity.
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Nentwich K, Ene E, Müller J, Berkowitz A, Kerber S, and Deneke T
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- Aged, 80 and over, Echocardiography, Transesophageal, Female, Humans, Ligation, Treatment Outcome, Atrial Appendage diagnostic imaging, Atrial Appendage surgery, Atrial Fibrillation diagnosis, Atrial Fibrillation diagnostic imaging, Cardiac Surgical Procedures
- Abstract
It has been shown that endocardial occlusion of the left atrial appendage (LAA) is equally effective in preventing embolic events compared to oral anticoagulation in patients with nonvalvular atrial fibrillation. An 82-year-old female patient was admitted for LAA occlusion for repetitive GI bleeding. She had high CHADSVASC Score and HASBLED with long persistent atrial fibrillation with many comorbities. The preprocedural transesophageal echo revealed a great mass in the left atrium (Picture 1). Cardiac surgery was denied, we performed an epicardial only ligation for closing the LAA. For this approach we performed an epicardial puncture and contrast injection within the pericardial space to delineate the LAA. An epicardial wire with a suction mechanism at its distal end was attached to the anterior lobe of the LAA. Using this epicardial wire the snare could be advanced over the appendage and closed down. Complete exclusion of the LAA was achieved. There were no procedural complications and the patient is doing well after 3 months., (© 2022 Wiley Periodicals LLC.)
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45. [Relevant anatomy of epicardial space for the electrophysiologists].
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Ene E, Didenko M, Berkovitz A, Nentwich K, Sonne K, Zhuravlev V, and Deneke T
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- Humans, Pericardium surgery, Phrenic Nerve surgery, Treatment Outcome, Cardiomyopathies, Catheter Ablation methods, Tachycardia, Ventricular diagnosis, Tachycardia, Ventricular surgery
- Abstract
The arrhythmogenic substrate in patients with Chagas cardiomyopathy, arrhythmogenic dysplasia, postmyocarditis nonischemic dilative cardiomyopathy as well as after extensive posterior or anterior wall myocardial infarction is predominantly located epicardially. This can necessitate epicardial access for an effective, substrate-based catheter ablation of the ventricular tachycardia (VT). Anterior percutaneous epicardial puncture represents the standard approach for epicardial VT ablation. The most important anatomical particularities that must be taken into account when performing an epicardial puncture or epicardial VT ablation are epicardial coronary arteries, left phrenic nerve and epicardial fat. The typical anatomic characteristics of the epicardial structures and resulting considerations for epicardial access are discussed here in detail., (© 2022. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)
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- 2022
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46. Safety aspects of very high power very short duration atrial fibrillation ablation using a modified radiofrequency RF-generator: Single-center experience.
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Mueller J, Halbfass P, Sonne K, Nentwich K, Ene E, Berkovitz A, Lehmkuhl L, Barth S, Simu GR, Waechter C, Behnes M, and Deneke T
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- Esophagus, Female, Humans, Male, Treatment Outcome, Atrial Fibrillation diagnostic imaging, Atrial Fibrillation surgery, Catheter Ablation adverse effects, Catheter Ablation methods, Pulmonary Veins diagnostic imaging, Pulmonary Veins surgery
- Abstract
Introduction: High power short duration (HPSD) ablation proved to be an effective and safe ablation technique for atrial fibrillation (AF). In former case series, a significant amount of postablation coagulation at the catheter tip as well as silent cerebral lesions (SCL) in postprocedural cerebral magnetic resonance (cMRI) have been identified in patients undergoing de-novo AF ablations with very high power 90 W short duration (vHPvSD) ablations using the QDot ablation catheter in combination with a novel RF generator (nGEN, Biosense Webster). Therefore, the RF generator software has been recently modified., Methods and Results: Consecutive patients undergoing a first AF ablation including pulmonary vein isolation (PVI) with vHPvSD (90 W, with a predefined ablation time of 3 s at posterior left atrium (LA) wall sites and 4 s at other ablation sites) using the QDOT Micro ablation catheter (Biosense Webster) in conjunction with the technically modified nGEN RF generator (software V1c; Biosense Webster) were included. Procedural characteristics including first-pass isolation per pulmonary vein (PV) pair and early reconnection location within the 30-min waiting period were recorded. In all patients postablation endoscopy to document any thermal esophageal injury (EDEL) and in eligible patients a cMRI to detect silent cerebral events (SCEs)/lesions were performed. All acute procedure-related complications were recorded during the time until hospital discharge. Furthermore, short-term and midterm success after 3 and 6-12 months of follow-up was investigated. In total, 34 consecutive patients (67 ± 9 years; 62% male; 68% paroxysmal AF) were included. First-pass isolation of all PVs was achieved in 6/34 (18%) patients. First-pass isolation was seen in 37/68 (54%) of PV pairs. Early reconnection occurred in 11 (32%) patients (including reconnections at posterior LA wall sites n = 6 and at nonposterior sites n = 5). No patient had an EDEL (0%). In 6/23 (26%) patients undergoing postablation cerebral MRI SCEs were identified. In six patients, coagulation on the catheter tip was detected at the end of the procedure. No further peri- or postprocedural complications were detected. Early AF recurrence before discharge was seen in 1/34 (3%) of the patients included in this study. Within 3 months 10/34 (29%) revealed AF recurrence during blanking period. After a mean follow-up of 7 months, 31/34 (88%) patients revealed sinus rhythm., Conclusion: AF ablation using 90 W vHPvSD with a specialized ablation catheter in conjunction with a recently modified RF generator was associated with no EDEL in the whole study cohort and 26% SCEs in a subgroup of patients undergoing acute postablation cerebral MRI. Accordingly, to our previously published results, a relevant number of catheter tip coagulations was identified in this patient cohort even after modifications of the RF generator. The vHPvSD ablation technique using the present and the previous generator seems to be associated with a very low rate of esophageal injury. However, the recently revised generator software also produced a relevant number of catheter tip coagulum formation and SCEs., (© 2022 Wiley Periodicals LLC.)
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- 2022
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47. Safety of very high-power short-duration radiofrequency ablation for pulmonary vein isolation: a two-centre report with emphasis on silent oesophageal injury.
- Author
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Halbfass P, Wielandts JY, Knecht S, Le Polain de Waroux JB, Tavernier R, De Wilde V, Sonne K, Nentwich K, Ene E, Berkovitz A, Mueller J, Lehmkuhl L, Reichart A, Lüsebrink U, Duytschaever M, and Deneke T
- Subjects
- Aged, Esophagus injuries, Humans, Male, Middle Aged, Treatment Outcome, Atrial Fibrillation diagnosis, Atrial Fibrillation surgery, Catheter Ablation adverse effects, Catheter Ablation methods, Pulmonary Veins surgery, Radiofrequency Ablation
- Abstract
Aims: Very high-power short-duration (vHPSD) via temperature-controlled ablation (TCA) is a new modality to perform radiofrequency pulmonary vein isolation (PVI), conceivably at the cost of a narrower safety margin towards the oesophagus. In this two-centre trial, we aimed to determine the safety of vHPSD-based PVI with specific emphasis on silent oesophageal injury., Methods and Results: Ninety consecutive patients with atrial fibrillation (AF) underwent vHPSD-PVI (90 W, 3-4 s, TCA) using the QDOT MICRO catheter, in conjunction with the nGEN (Bad Neustadt, n = 45) or nMARQ generator (Bruges, n = 45). All patients underwent post-ablation oesophageal endoscopy. Procedural parameters and complications were recorded. A subgroup of 21 patients from Bad Neustadt underwent cerebral magnetic resonance imaging (cMRI) to detect silent cerebral events (SCEs). Mean age was 67 ± 9 years, 59% patients were male, and 66% patients had paroxysmal AF. Pulmonary vein isolation was obtained in all cases after 96 ± 29 min. No steam pop, cardiac tamponade, stroke, or fistula was reported. None of the 90 patients demonstrated oesophageal ulceration (0%). Charring was not observed in the nMARQ cohort (0% vs. 11% in the nGEN group). In 5 out of 21 patients (24%), cMRI demonstrated SCE (exclusively nGEN cohort)., Conclusion: Temperature-controlled vHPSD catheter ablation allows straightforward PVI without evidence of oesophageal ulcerations or symptomatic complications. Catheter tip charring and silent cerebral lesions when using the nGEN generator have led to further modification., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)
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- 2022
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48. Acute and long-term outcomes of VT radiofrequency catheter ablation in patients with versus without an intramural septal substrate.
- Author
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Halbfass P, Ludwig D, Sonne K, Nentwich K, Ene E, Berkovitz A, Foldyna B, Barth S, Müller J, Lehmkuhl L, Lüsebrink U, Waechter C, and Deneke T
- Abstract
Introduction: Aim of this study was to evaluate efficacy and safety of ventricular tachycardia (VT) catheter ablation in patients with structural heart disease (SHD) in relation to the presence of an intramural septal substrate., Methods: Consecutive patients undergoing VT ablation between January 2019 and October 2020 were included. All patients were stratified based on the presence of relevant septal substrate and freedom from VT recurrences were analyzed., Results: In total, 199 consecutive patients (64.2 ± 13.0 years; 89% male; 55% ischemic cardiomyopathy (ICM)) undergoing VT ablation were included. 129/199 patients (65%) showed significant septal substrate (55/90 patients (61%) with non-ischemic cardiomyopathy (NICM) compared to 74/109 patients (68%) with ICM; p = 0.37). Acute procedural success with elimination of all inducible VTs was achieved in 66/70 patients (94%) without and in 103/129 patients (80%) with a septal substrate (p = 0.007). In the cohort including patients with a clinical FU, 15/60 patients (25%) without a septal substrate and 48/123 patients (39%) with a septal substrate experienced VT recurrence during a FU of 8.1 ± 5.9 months (p = 0.069)., Conclusion: Presence of septal VT substrate in patients with a structural heart disease or coronary artery disease is common. Acute success of VT catheter ablation was significantly higher and mid-term success tended to be higher in patients without a septal substrate., Competing Interests: Declaration of competing interest None to declare., (Copyright © 2021 Indian Heart Rhythm Society. Published by Elsevier B.V. All rights reserved.)
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- 2022
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49. [A 19-year-old woman with palpitations and mitral regurgitation].
- Author
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Deneke T, Berkovitz A, Ene E, Sonne K, Simu G, Müller J, Lehmkuhl L, Müller M, and Nentwich K
- Subjects
- Adult, Arrhythmias, Cardiac, Echocardiography, Female, Humans, Mitral Valve diagnostic imaging, Young Adult, Mitral Valve Insufficiency diagnosis, Mitral Valve Insufficiency surgery, Mitral Valve Prolapse complications, Mitral Valve Prolapse diagnosis, Mitral Valve Prolapse surgery
- Abstract
A young woman presented with palpitations. Holter monitoring revealed frequent premature ventricular complexes; echocardiography showed high-degree mitral regurgitation due to mitral valve prolapse. While mitral valve replacement or repair were being discussed, a different therapy was applied after further diagnostic work-up of the patient which in retrospect appears even more efficient., (© 2021. Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)
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- 2021
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50. Esophagopericardial Fistula: The Wolf in Sheep's Clothing.
- Author
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Deneke T, Sonne K, Ene E, Berkovitz A, and Nentwich K
- Abstract
Competing Interests: The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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- 2021
- Full Text
- View/download PDF
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