Atrial pacing in Fontan patients: The effect of transvenous lead on clot burden

doi:10.1016/j.hrthm.2021.06.1191

Heart Rhythm

Volume 18, Issue 11, November 2021, Pages 1860-1867

https://doi.org/10.1016/j.hrthm.2021.06.1191 Get rights and content

Background

Transvenous permanent pacemaker (PPM) implantation is an available option for Fontan patients with sinus node dysfunction. However, the thrombogenic potential of leads within the Fontan baffle is unknown.

Objective

The purpose of this study was to compare the clot burden in Fontan patients with a transvenous atrial PPM to those without a PPM and those with an epicardial PPM.

Methods

This was a retrospective cohort study of all transvenous PPM implantations in Fontan patients followed at our institution (2000–2018). We performed frequency matching on Fontan type and age group. Primary outcome was identification of intracardiac clot, pulmonary embolus, or embolic stroke.

Results

Of 1920 Fontan patients, 58 patients (median age 23 years; interquartile range [25th–75th percentiles] 14–33) at the time of transvenous PPM implantation and 174 matched subjects formed our cohort. The type of Fontan performed in case subjects was right atrium–pulmonary artery or right atrium–right ventricle conduit (54%), lateral tunnel (43%), and extracardiac (3%). The cumulative incidence of clot was highest in patients with transvenous PPM, followed by patients with epicardial PPM and no PPM (1.2 vs 0.87 vs 0.67 per 100 person-years of follow-up, respectively). In multivariable analysis, anticoagulation and/or antiplatelet therapy were protective against clot and resulted in reduction of clot risk by 3-fold (incidence rate ratio 0.33; 95% confidence interval 0.21–0.53; P <.001).

Conclusion

In a large cohort of Fontan patients matched for age and Fontan type, patients with transvenous PPM had a higher but not statistically significant incidence of clot compared to those with no PPM and epicardial PPM. Patients treated with warfarin/aspirin had lower clot risk.

Introduction

Sinus node dysfunction (SND) is a common complication in Fontan patients, with a large proportion requiring cardiac pacing.¹^,² In fact, permanent pacemaker (PPM) implantation is the most frequent surgical reintervention in this population.³ Traditionally, Fontan patients underwent repeat thoracotomy or sternotomy for epicardial PPM. However, epicardial leads have their pitfalls. In addition to the nontrivial risk of repeat sternotomy, previous studies investigating the difference in lead characteristics and performance in Fontan patients demonstrated that epicardial devices have a higher rate of lead failure and a shorter generator longevity.²^,⁴ Considering these major disadvantages, a less invasive approach becomes appealing to both patients and physicians.

Transvenous (TV) PPM may be an available option for Fontan patients with SND. A few case reports describing this technique have been published.5, 6, 7, 8 Nonetheless, an important question regarding the risk of clots in the presence of a TV lead within the Fontan pathway remains unanswered. It has been postulated that the presence of a TV pacemaker increases the risk of thrombus formation in the Fontan circulation. As such, some clinicians recommend epicardial systems in their place, or they have started additional anticoagulation therapy in those with endocardial pacemakers. This recommendation is based largely on expert opinions and limited data.⁹ We sought to investigate the clot burden in Fontan patients with a TV atrial pacemaker and compare it to the burden in those without a pacemaker and those with an epicardial pacemaker.

Section snippets

Study design

We conducted a retrospective cohort study of all Fontan patients who underwent TV atrial PPM for SND and were evaluated at our institution between January 2000 and December 2018. Case subjects include Fontan patients with a TV atrial PPM. They were compared to Fontan patients with an epicardial PPM and to a control group of Fontan patients with no PPM. The 2 comparison groups were selected by performing frequency matching for age group (8–19 years, 20–39 years, and ≥40 years) and Fontan type in

Baseline characteristics

Of 1920 Fontan patients, 232 were included in our study: 58 with TV PPM, 116 had no PPM, and 58 with epicardial PPM. Patient demographics are summarized in Table 2. The majority of case subjects were male (n = 32 [55%]) and had a median age of 4 (0.6–30) years at the time of Fontan operation. Of the TV PPM cohort, 42 (72%) had a history of atrial arrhythmia, and 23 (40%) had ever undergone an EP ablation procedure. The majority of this group were maintained on warfarin or a novel oral

Discussion

In a large cohort study, we describe our institutional experience with TV atrial PPM implantation in Fontan patients and its impact on clot formation. The major findings were as follows. (1) Patients with TV PPM had a higher but not statistically significant incidence of clot compared to those with no PPM and epicardial PPM (1.2 vs 0.68 vs 0.87 per 100 person-years of follow-up, respectively). (2) Fontan patients with TV PPM are more likely to be anticoagulated in comparison to those with no

Conclusion

In a large cohort of Fontan patients matched for age and Fontan type, patients with TV PPM had a higher but not statistically significant incidence of clot compared to those without PPM and those with epicardial PPM. The risk is predominantly in those with RA-PA, and not in patients with lateral tunnel Fontan. The use of either antiplatelet or anticoagulation therapy reduced the risk of thromboembolism 3-fold. TV atrial PPM implantation is feasible with lead longevity comparable to that of

References (20)

A.C. Egbe et al.
Outcomes of cardiac pacing in adult patients after a Fontan operation
Am Heart J
(2017)
E. O’Leary et al.
Transvenous approach to pacemaker lead implantation for sinus node dysfunction after extracardiac lateral tunnel Fontan conduit placement
HeartRhythm Case Rep
(2016)
J. Newcombe et al.
Extracardiac autologous pericardial tunnel Fontan allows implantation of an endocardial atrial lead for sinus node dysfunction
Ann Thorac Surg
(2014)
G. Ho et al.
Prevalence and short-term clinical outcome of mobile thrombi detected on transvenous leads in patients undergoing lead extraction
JACC Clin Electrophysiol
(2019)
A.C. Egbe et al.
Prevalence and outcome of thrombotic and embolic complications in adults are Fontan operation
Am Heart J
(2017)
A.C. Egbe et al.
Thrombotic and embolic complications associated with atrial arrhythmia after Fontan operation. Role of prophylactic therapy
J Am Coll Cardiol
(2016)
C. Deshaies et al.
Thromboembolic risk after atriopulmonary, lateral tunnel, and extracardiac conduit Fontan surgery
J Am Coll Cardiol
(2019)
T.G. Wilson et al.
Twenty-five year outcomes of the lateral tunnel fontan procedure
Semin Thorac Cardiovasc Surg
(2017)
D.Y. Mah et al.
Coronary artery compression from epicardial leads: more common than we think
Heart Rhythm
(2018)
J. Rychik et al.
Evaluation and management of the child and adult with Fontan circulation: a scientific statement from the American Heart Association
Circulation
(2019)

There are more references available in the full text version of this article.

Cited by (5)

Use of an electroanatomic mapping system with high-density multipolar mapping catheters to guide transvenous atrial pacing lead implantation in a Fontan patient
2024, HeartRhythm Case Reports
Lead Management in Patients with Congenital Heart Disease
2023, Cardiac Electrophysiology Clinics
Cardiac Implantable Electronic Devices in the Fontan Patient
2022, Canadian Journal of Cardiology
Citation Excerpt :
It has been shown that shunts, even left to right, increase the risk of systemic thromboembolic events in patients with transvenous leads in place.23 In a large cohort of Fontan patients, those with transvenous leads had a numerically higher incidence of thromboembolic complications that was not statistically significant compared with patients with epicardial leads or without pacemakers (1.2 vs 0.87 vs 0.67 per 100 person-years, respectively).24 In the same retrospective study, anticoagulation and antiplatelet therapy were associated with a 3-fold lower risk of clot (incidence rate ratio, 0.33; 95% CI, 0.21-0.53; P < 0.001).
As a result of remarkable progress in operative techniques and cardiology care during childhood, Fontan patients continue to age and require team-based multidisciplinary expertise to manage complications encountered in adulthood. They face particular challenges in terms of altered hemodynamic stressors, cardiac and hepatic failure, and arrhythmias. Arrhythmias in Fontan patients are highly prevalent and associated with underlying anatomy, surgical technique, and postoperative sequelae. Diagnostic tools, treatments, and device strategies for arrhythmias in Fontan patients should be adapted to the specific anatomy, type of surgical repair, and clinical status. Great strides in our understanding of arrhythmia mechanisms, options and techniques to obtain access to relevant cardiac structures, and application of both old and new technologies have contributed to improving cardiac implantable electronic device (CIED) therapies for this unique population. In this state-of-the-art review, we discuss the various arrhythmias encountered in Fontan patients, their diagnosis, and options for treatment and prevention, with a focus on CIEDs. Throughout, access challenges particular to the Fontan circulation are considered. Recently developed technologies, such as the subcutaneous implantable cardioverter defibrillator, carry the potential to be transformative but require awareness of Fontan-specific issues. Moreover, new leadless pacing technology represents a promising strategy that may soon become applicable to Fontan patients with sinus-node dysfunction. CIEDs are essential tools in managing Fontan patients, but the complex clinical scenarios that arise in this patient population are among the most challenging for the electrophysiologist treating patients with congenital heart disease.
En raison des progrès remarquables accomplis en matière de techniques opératoires et de soins cardiologiques pédiatriques, les patients qui ont subi l’intervention de Fontan continuent d’avancer en âge et ont besoin d’une expertise multidisciplinaire pour gérer les complications qu’ils rencontrent à l’âge adulte. Ces patients doivent composer avec des difficultés particulières ayant à voir avec la modification des facteurs de stress hémodynamique, l’insuffisance cardiaque et hépatique, et les arythmies. Ces dernières sont très fréquentes chez les patients ayant subi l’intervention de Fontan et se trouvent associées à l’anatomie sous-jacente, à la technique chirurgicale et aux séquelles postopératoires. Les outils diagnostiques, les traitements et les stratégies technologiques visant à remédier aux arythmies chez les patients ayant subi l’intervention de Fontan devraient être adaptés aux ca-ractéristiques anatomiques individuelles, au type de réparation chi-rurgicale et au tableau clinique. Les grandes avancées sur le plan de notre compréhension des mécanismes de l’arythmie, les options et les techniques dont nous disposons pour accéder aux structures cardiaques d’intérêt, de même que la mise en œuvre de technologies an-ciennes et nouvelles ont contribué à améliorer les traitements faisant appel à des dispositifs cardiaques électroniques implantables (DCEI) dans cette population unique. Le présent article dresse un bilan exhaustif de la question. Nous y abordons les diverses formes d’a-rythmies qui touchent les patients ayant subi l’intervention de Fontan, leur diagnostic et les options de traitement et de prévention, en accordant une attention toute particulière aux DCEI. Les problèmes d’accès que pose la circulation de Fontan sont pris en compte tout au long de notre article. Les technologies récemment mises au point, comme le défibrillateur cardioverteur implantable sous-cutané, pourraient être porteuses de changements profonds, mais elles nécessitent une prise de conscience des problèmes qui se rattachent à l’intervention de Fontan. En outre, la nouvelle technologie de stimulation sans sonde se révèle une stratégie prometteuse qui pourrait bientôt devenir applicable dans les cas de dysfonctionnement du nœud sinusal chez les patients ayant subi l’intervention de Fontan. Les DCEI sont des outils essentiels pour la prise en charge des patients ayant subi l’intervention de Fontan. Cependant, les scénarios cliniques complexes observés au sein de cette population de patients font partie de ceux qui posent le plus de difficultés aux électrophysiologistes qui traitent les patients atteints de cardiopathies congénitales.
Complex Congenital Heart Disease in the Adult
2024, Annual Review of Medicine
Hemodynamic Impact of Atrial Pacing in Patients with Fontan Physiology and Junctional Rhythm: A Cardiac Catheterization Study
2022, Pediatric Cardiology

: Funding sources: The authors have no funding sources to disclose. Disclosures: The authors have no conflicts of interest to disclose.

View full text

ClinicalDevicesAtrial pacing in Fontan patients: The effect of transvenous lead on clot burden

Background

Objective

Methods

Results

Conclusion

Introduction

Section snippets

Study design

Baseline characteristics

Discussion

Conclusion

Am Heart J

HeartRhythm Case Rep

Ann Thorac Surg

JACC Clin Electrophysiol

Am Heart J

J Am Coll Cardiol

J Am Coll Cardiol

Semin Thorac Cardiovasc Surg

Heart Rhythm

Evaluation and management of the child and adult with Fontan circulation: a scientific statement from the American Heart Association

Circulation

Clinical
Devices
Atrial pacing in Fontan patients: The effect of transvenous lead on clot burden