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Left atrial appendage closure after cryoballoon ablation in patients with atrial fibrillation

Verschluss des linken Herzohrs nach Kryoballonablation bei Patienten mit Vorhofflimmern

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Abstract

Background

Cryoballoon ablation (CBA) is effective for patients with drug-refractory symptomatic atrial fibrillation (AF). For patients with a high risk of stroke (CHA2DS2-VASc score ≥2), life-long oral anticoagulation therapy should be continued even after successful catheter ablation. We investigated the safety and efficacy of concomitant use of a second-generation CBA catheter for pulmonary vein isolation (PVI) and a left atrial appendage closure (LAAC) device in patients with AF.

Methods

We enrolled 27 patients (64.7 ± 6.3 years, 74% male, 63% paroxysmal AF, 37% persistent AF, 4.8 ± 1.4 CHA2DS2-VASc score, and 3.6 ± 1.3 HAS-BLED score). In total, 85% of the patients had a prior stroke or TIA, and 30% of patients had a clinical history of bleeding. Patients received a CBA for PVI and underwent occlusion of the LAA with an LAAC device. The efficacy of CBA was defined as lack of arrhythmia recurrence (AF, atrial flutter, and/or atrial tachycardia lasting ≥30 s) after a 90-day blanking period. The success of LAAC was determined by the rate of stroke, TIA, and/or bleeding events.

Results

The mean procedural time for CBA and LAAC was 80 ± 16 min and 44 ± 12 min, respectively. Acute PVI by CBA was achieved in 100% of the procedures, and 96% of patients obtained acute LAAC device placement during the procedure. Upon complete release of the LAAC device, only 62% patients (16/26) had no detectable leakage during intraprocedural transesophageal echocardiography. Three patients experienced an acute complication: a pericardial effusion and two phrenic nerve palsy events. Mean follow-up was 18 months (range 9–23 months), and freedom from AF recurrence was 74% (20/27).

Conclusion

The intraprocedural combination of CBA and LAAC is feasible in patients with non-valvular AF with a high risk of stroke, TIA, and/or bleeding. Larger long-term randomized studies are needed to judge the overall safety and efficacy of the combined procedure.

Zusammenfassung

Hintergrund

Die Kryoballonablation (CBA) ist bei Patienten mit medikamentenresistentem symptomatischem Vorhofflimmern („atrial fibrillation“, AF) wirksam. Besteht ein hohes Risiko für einen Schlaganfall (CHA2DS2-VASc-Score ≥2), so sollte bei solchen Patienten die Antikoagulationstherapie lebenslang fortgeführt werden, auch nach einer erfolgreichen Katheterablation. Die Autoren untersuchten die Sicherheit und Wirksamkeit der gleichzeitigen Anwendung eines CBA-Katheters der 2. Generation für die Pulmonalvenenisolation (PVI) und eines Systems zum Verschluss des linken Herzohrs („left atrial appendage closure“, LAAC) bei Patienten mit AF.

Methoden

In die Studie wurden 27 Patienten im Alter von 64,7 ± 6,3 Jahren einbezogen; 74% männlich; 63% paroxysmales AF; 37% persistierendes AF; CHA2DS2-VASc-Score (kongestive Herzinsuffizienz, Hypertonie, Alter >75 Jahre: 2 Punkte, Diabetes, Schlaganfall/TIA: 2 Punkte, vaskuläre Erkrankung, Alter: 65–74 Jahre, „sex“/Geschlecht: weiblich): 4,8 ± 1,4; HAS-BLED-Score (Hypertonie, abnormale Nierenfunktion, Schlaganfall, Blutung, labile INR-Einstellung, „elderly“/Alter, „drugs“/Medikamente): 3,6 ± 1,3. Anamnestisch gaben 85% der Patienten einen Schlaganfall oder eine TIA (transitorische ischämische Attacke) an, 30% eine Blutung. Bei den Patienten erfolgte eine CBA zur PVI und der Verschluss des linken Herzohrs mit einem LAAC-System. Die Wirksamkeit der CBA war als das Nichtwiederauftreten der Arrhythmie (AF, Vorhofflattern und/oder Vorhoftachkardie ≥30 s) nach einer Stabilisierungsphase („blanking period“) von 90 Tagen definiert. Der Erfolg der LAAC-Intervention wurde anhand der Rate für Schlaganfall, TIA und/oder Blutungen ermittelt.

Ergebnisse

Die mittlere Interventionsdauer für CBA und LAAC betrug 80 ± 16 min bzw. 44 ± 12 min. In 100% der Eingriffe wurde eine akute PVI mit der CBA erzielt, und bei 96% der Patienten erfolgte die Platzierung des LAAC-Systems während des Eingriffs. Bei vollständiger Freigabe des LAAC-Systems war nur bei 62% der Patienten (16/26) keine Leckage in der intraprozeduralen transösophagealen Echokardiographie erkennbar. Eine akute Komplikation trat bei 3 Patienten auf: einmal ein Perikarderguss und 2 Fälle mit Parese des N. phrenicus. Im Mittel betrug die Nachbeobachtungsdauer 18 Monate (Spanne: 9–23 Monate), und die AF-Rezidivfreiheit lag bei 74% (20/27).

Schlussfolgerung

Die Kombination von CBA und LAAC in einem Eingriff ist bei Patienten mit nichtvalvulärem AF und hohem Risiko für Schlaganfall, TIA und/oder Blutung praktikabel. Es sind größere randomisierte Langzeitstudien erforderlich, um die Gesamtsicherheit und -wirksamkeit der kombinierten Intervention zu beurteilen.

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Abbreviations

AAD:

antiarrhythmic drug

AF:

atrial fibrillation

AFL:

atrial flutter

AT:

atrial tachycardia

CBA:

cryoballoon ablation

CT:

computerized tomography

LA:

left atrium

LAA:

left atrial appendage

LAAC:

left atrial appendage closure

LAAI:

left atrial appendage isolation

OAC:

oral anticoagulation

PV:

pulmonary vein

PVI:

pulmonary vein isolation

RFCA:

radiofrequency catheter ablation

TEE:

transesophageal echocardiography

TIA:

transient ischemic attack

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Acknowledgements

We thank Dr. Hae Lim for editorial assistance and language modifications.

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Authors and Affiliations

  1. Center for Arrhythmia Diagnosis and Treatment, Fu Wai Hospital, PUMC & CAMS, Beijing, China

    Jun Liu MD, PhD, Yu Xia MD, Hao Zhang MD, Xiaofeng Li MD, Shu Zhang MD, PhD & Pihua Fang MD, PhD

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  1. Jun Liu MD, PhD
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  2. Yu Xia MD
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  4. Xiaofeng Li MD
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  5. Shu Zhang MD, PhD
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Correspondence to Jun Liu MD, PhD.

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Conflict of interest

J. Liu, Y. Xia, H. Zhang, X. Li, S. Zhang, and P. Fang declare that they have no competing interests.

For this article no studies with human participants or animals were performed by any of the authors. All studies performed were in accordance with the ethical standards indicated in each case.

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Liu, J., Xia, Y., Zhang, H. et al. Left atrial appendage closure after cryoballoon ablation in patients with atrial fibrillation. Herz 46 (Suppl 1), 82–88 (2021). https://doi.org/10.1007/s00059-019-04880-4

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  • DOI: https://doi.org/10.1007/s00059-019-04880-4

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