Abstract

Abstract Background Cardioneuroablation(CNA) is promising and innovative method to cure vagally mediated bradycardia.However, according to current ESC2021 guidelines patients may have indications for permanent pacing. CNA is still referred to patients as an experimental and alternative method,not being recommended in guidelines due to too small amount of evidence.The study sought to validate criteria for permanent pacemaker(PPM) implantation,discontinuation of PPM therapy(PPMT) and risk of PPM implantation after CNA in a large population of patients qualified for electrophysiologic study(EPS),Extracardiac vagal nerve stimulation(ECVS) and CNA. Methods Data were collected from POLish prospective multicentre CardioneuroAblation registry(POLCA) with comprehensive management, interdisciplinary consultations, state-of-art autonomic tests, atropine tests, EPS as well as ECVS. Shared-decision making was used to developed patient-oriented therapy with clear declaration of fulfilling indications for PPMT according to ESC guidelines,(when applicable) and CNA only as alternative and developing technique. Results A total of 195 consecutive adult patients(mean age:55,6+/-14,3 years; min 20,0 Q1 44,96-Q2 58,4 - Q3 67,2; max 82;107(54%)females,) underwent first CNA. Out of them, 17(8,2%) had already PPM. According to current guidelines 100/178(51%) patients had de novo indications for PPM implantation prior to CNA including: SND(n=88,45%), AVB(n=21, 10%), TBS (n=26, 13%), CI-VVS(n=41; 21%),M-VVS(n=1;0,5%), CI-CCS(n=41;21%) or mixed etiologies (n=45;23%). Indications for de novo PMT were present in 32(37%) patients above age 60. During moderate-term (23,7+/-10,3 months), no patient died, and only 10 had syncope (which was diagnosed as orthostatic or vasodepressive). Despite preprocedural positive atropine test and positive ECVS, 6 out of 195 patients (had early and elective PPM implantation due to coexistence of functional and structural bradycardia(n=3) or bradycardia recurrences(n=2) or severe sinus chronotropic incompetence(n=1). There were 7(3,5%) major complications (tamponade (n=2), pericarditis(n=2), pericardial effusion(n=1), femoral aneurysm(n=1), pneumothorax(n=1) of CNA. Only 4 of patients with indications for PPM implantation before CNA still had those indications during follow-up. Out of 6 patients with late PPM implantations after CNA, 1 patient had syncope due to development of AVB. Conclusions About 51%patients referred for CNA had indications for PPM therapy. CNA in subgroup of patients with functional bradycardia is becoming alternative choice to PPMT and allowed to give up PPM implantation at least temporarily in 96%patients without prior PPMT. However some patients require PMT due to failed CNA or reinnervation,but also co-existence or development of complex structural bradyarrhythmias.

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