Rationale and design of SAN.OK randomized clinical trial and registry: Comparison of the effects of evidence-based pacemaker therapy and cardioneuroablation in sinus node dysfunction

Stec, Sebastian; Jankowska‐Polańska, Beata; Jagielski, Dariusz; Wileczek, Antoni; Josiak, Krystian; Śledź, Janusz; Reichert, Agnieszka; Kustroń, Anna; Zyśko, Dorota; Skonieczny, Bartosz; Fedorowski, Artur; Ratajska, Anna; Zając, Magdalena; Hering, Dagmara; Wąsek, Wojciech; Stodółkiewicz-Nowarska, Edyta

doi:10.5603/cj.a2022.0103

Cited by 3 publications

(2 citation statements)

References 18 publications

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“…Single cases of patients were reported in whom pacing was discontinued after CNA as a result of bradycardia treatment, complications of pacemaker therapy, or when other etiologies of a transient loss of consciousness were misdiagnosed [ 13 , 14 , 29 ]. Moreover, a national Danish survey including young adults (age < 50 years) with pacemakers and AVBs demonstrated that the incidences of reflex and unexplained etiology were 5% and 50%, respectively [ 30 , 31 ]. Shared decision making may be particularly relevant in young patients when the initial indications for pacemaker implantation were imprecise or appear to have resolved (e.g., transient heart block during an infection), or when control EPS including ECVS confirmed the efficacy of CNA [ 1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 ].…”

Section: Discussionmentioning

confidence: 99%

Shared Decision Making and Cardioneuroablation Allow Discontinuation of Permanent Pacing in Patients with Vagally Mediated Bradycardia

Stec,

Wileczek,

Reichert

et al. 2023

JCDD

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Background: Safe discontinuation of pacemaker therapy for vagally mediated bradycardia is a dilemma. The aim of the study was to present the outcomes of a proposed diagnostic and therapeutic process aimed at discontinuing or not restoring pacemaker therapy (PPM) in patients with vagally mediated bradycardia. Methods: The study group consisted of two subgroups of patients with suspected vagally mediated bradycardia who were considered to have PPM discontinued or not to restore their PPM if cardioneuroablation (CNA) would successfully treat their bradycardia. A group of 3 patients had just their pacemaker explanted but reimplantation was suggested, and 17 patients had preexisting pacemakers implanted. An invasive electrophysiology study was performed. If EPS was negative, extracardiac vagal nerve stimulation (ECVS) was performed. Then, patients with positive ECVS received CNA. Patients with an implanted pacemaker had it programmed to pace at the lowest possible rate. After the observational period and control EPS including ECVS, redo-CNA was performed if pauses were induced. The decision to explant the pacemaker was obtained based on shared decision making (SDM). RESULTS: After initial clinical and electrophysiological evaluation, 17 patients were deemed eligible for CNA (which was then performed). During the observational period after the initial CNA, all 17 patients were clinically asymptomatic. The subsequent invasive evaluation with ECVS resulted in pause induction in seven (41%) patients, and these patients underwent redo-CNA. Then, SDM resulted in the discontinuation of pacemaker therapy or a decision to not perform pacemaker reimplantation in all the patients after CAN. The pacemaker was explanted in 12 patients post-CNA, while in 2 patients explantation was postponed. During a median follow-up of 18 (IQR: 8–22) months, recurrent syncope did not occur in the CNA recipients. Conclusions: Pacemaker therapy in patients with vagally mediated bradycardia could be discontinued safely after CNA.

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Section: Discussionmentioning

confidence: 99%

Shared Decision Making and Cardioneuroablation Allow Discontinuation of Permanent Pacing in Patients with Vagally Mediated Bradycardia

Stec,

Wileczek,

Reichert

et al. 2023

JCDD

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“…Anatomically guided biatrial and binodal CNA was performed, with fluoroscopic and ultrasonographic guidance for ECVS [8]. CNA was performed using three-dimensional electroanatomic systems (EnSite Velocity/Precision Mapping Systems, Abbott, US), as reported previously [8][9][10]. Six GPs were targeted: superior septal GP (left and right), inferior septal GP (left and right), vena cava superior/aortic root GP, and left superior GP.…”

Section: Methodsmentioning

confidence: 99%

Reevaluation of the indications for permanent pacemaker implantation after cardioneuroablation

Wileczek,

Stodolkiewicz-Nowarska,

Reichert

et al. 2023

Kardiol Pol

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Preventive and Personalized Strategies in Ambulatory and Clinical Cardiac Electrophysiology

Jagielski,

Skoczyński,

Pawłowski

et al. 2023

Advances in Predictive, Preventive and Personalised Medicine

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Rationale and design of SAN.OK randomized clinical trial and registry: Comparison of the effects of evidence-based pacemaker therapy and cardioneuroablation in sinus node dysfunction

Cited by 3 publications

References 18 publications

Shared Decision Making and Cardioneuroablation Allow Discontinuation of Permanent Pacing in Patients with Vagally Mediated Bradycardia

Shared Decision Making and Cardioneuroablation Allow Discontinuation of Permanent Pacing in Patients with Vagally Mediated Bradycardia

Reevaluation of the indications for permanent pacemaker implantation after cardioneuroablation

Preventive and Personalized Strategies in Ambulatory and Clinical Cardiac Electrophysiology

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