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Archives of cardiovascular diseases
Volume 111, n° 5
pages 332-339 (mai 2018)
Doi : 10.1016/j.acvd.2017.07.006
Received : 23 January 2017 ;  accepted : 31 July 2017
Clinical research

Electrical storm in the early phase of HeartMate® II device implantation: Incidence, risk factors and prognosis
Orage rythmique à la phase précoce de l’implantation d’un HeartMate® II. Incidence, facteurs de risque et pronostic
 

Jerome Corre a, , François Picard b, Rodrigue Garcia a, Adlane Zemmoura a, Nicolas Derval a, Arnaud Denis a, c, Antoine Romen b, Karine Nubret b, Pierre Jais a, c, Michel Haissaguerre a, c, Pierre Dos Santos a, Laurent Barandon d, Frederic Sacher a, c
a Service de rythmologie, hôpital cardiologique du Haut-Lévêque, 1, avenue Magellan, 33600 Pessac, France 
b Service d’insuffisance cardiaque, hôpital cardiologique du Haut-Lévêque, 33600 Pessac, France 
c LIRYC Institute, Inserm 1045, University of Bordeaux, Bordeaux, France 
d Service de chirurgie cardiaque, hôpital cardiologique du Haut-Lévêque, Pessac, France 

Corresponding author.
Summary
Background

Ventricular arrhythmia is common after left ventricular assist device (LVAD) implantation, especially in the early postoperative phase (<30 days).

Aim

To identify the incidence of and risk factors for electrical storm (ES) occurring within 30 days of HeartMate® II implantation.

Methods

We reviewed data from all consecutive patients undergoing HeartMate® II device implantation at our institution from January 2008 to December 2014. Patient demographic data, pharmacotherapies and outcomes were collected. The primary endpoint was occurrence of early ES (within 30 days of surgery), defined as three or more separate episodes of sustained ventricular arrhythmia within a 24-hour interval, requiring appropriate therapy.

Results

Forty-three patients (mean age 56.7±11.2 years; 39 men) were included. At HeartMate® II implantation, mean left ventricular ejection fraction was 20±5%, 32 (74.4%) patients had ischaemic cardiomyopathy and 31 (72.1%) were implanted with an indication of bridge to cardiac transplantation. During follow-up, 12 (27.9%) patients experienced early ES after HeartMate® II implantation (median delay 9.1±7.8 days). Early ES was more frequent in larger patients (body surface area 1.99 vs 1.81 m2; P <0.01), tended to be associated with previous sustained ventricular tachycardia (50.0% vs 22.6%; P =0.08), previous implantable cardioverter-defibrillator implantation (66.7% vs 38.7%; P =0.09), discontinuation of long-term beta-blocker therapy (75.0% vs 45.2%; P =0.08), weaning of adrenergic drugs after the third day (66.7% vs 35.5%; P =0.06) and the use of extracorporeal life support (50% vs 22.6%; P =0.079), but was not associated with the cardiomyopathy aetiology or the indication for assistance. Catheter ventricular tachycardia ablation was performed in six (14.0%) patients. Early ES was associated with a significantly higher all-cause mortality rate at the 30th day (33.3% vs 6.5%; P =0.02).

Conclusion

ES is a common and pejorative feature in the early postoperative period.

The full text of this article is available in PDF format.
Résumé
Introduction

L’arythmie ventriculaire (AV) est fréquente après l’implantation d’une assistance ventriculaire gauche (AVG), particulièrement dans la phase postopératoire précoce (30 premiers jours). Nous avons cherché à identifier l’incidence et les facteurs de risque des orages rythmiques (OR) survenant précocement après implantation d’une prothèse HeartMate® II (HM2, Thoratec Corporation, Plesanton, États-Unis).

Méthodes

Nous avons analysé les données de tous les patients implantés d’un HM2 dans notre institution de janvier 2008 jusqu’à décembre 2014. Les données démographiques, pharmacologiques et le devenir ont été recueillis. Le critère principal était la survenue d’un OR précoce (dans les 30jours après la chirurgie) – défini comme la survenue, sur un intervalle de 24heures, d’au moins 3 épisodes distincts d’AV soutenue ayant nécessité une thérapie appropriée.

Résultats

Quarante-trois patients (39 homes, âge 57±11 ans) ont été inclus. À l’implantation, la FEVG moyenne était de 20±5 %, 32 (74 %) avaient une cardiomyopathie ischémique, 31 (72 %) ont été implantés dans l’attente d’une transplantation cardiaque. Durant le suivi, 12 patients (28 %) ont présenté un OR précoce, avec un délai médian de 9±8jours. Les OR précoces étaient significativement plus fréquents chez les patients avec une large surface corporelle (1,99 vs 1,81 m2, p <0,01) et tendaient à être associés aux patients avec un antécédent de tachycardie ventriculaire (TV) soutenue (50 % vs 22 %, p =0,08), porteurs d’un défibrillateur automatique (66,7 % vs 38,7 %, p = 0,09), à l’arrêt d’un traitement prolongé par bêtabloquant (75 % vs 45 %, p = 0,08), au sevrage des drogues adrénergiques après le troisième jour (66,7 % vs 35,5 %, p = 0,06) et au recours à une assistance cardiaque extracorporelle (50 % vs 22,6 %, p =0,079), tandis qu’ils n’étaient associés ni à l’étiologie de la cardiopathie ni à l’indication de l’assistance. Une ablation de TV a été réalisée chez 6 patients (14 %) sous HM2. Les OR précoces étaient associés à une surmortalité à j30 (33,3 % vs 6,5 %, p = 0,02).

Conclusion

Les OR postopératoires précoces sont une complication fréquente grevant le pronostic des patients.

The full text of this article is available in PDF format.

Keywords : Ventricular arrhythmia, Electrical storm, Endocardial ventricular tachycardia ablation, Left ventricular assist device, HeartMate® II, Electromagnetic interference

Mots clés : Arythmie ventriculaire, Orage rythmique, Ablation endocardique de tachycardie ventriculaire, Assistance ventriculaire gauche, HeartMate® II, Interférences électromagnétiques

Abbreviations : ES, ICD, LVAD, LVEDD, LVEF, VA, VT


Background

The left ventricular assist device (LVAD) has emerged as a beneficial new therapeutic option in end-stage congestive heart failure, improving survival and quality of life [1, 2], with an increasing number of LVAD implantations being performed for both destination therapy and as a bridge to cardiac transplantation [3]. However, the complications of these cardiac mechanical assistances are frequent, including bleeding, infections, right ventricular failure and cardiac arrhythmias [3].

Ventricular arrhythmias (VAs) seem common in patients undergoing LVAD implantation [4, 5, 6]. Although the occurrence of sustained VA is often well tolerated in this population under assistance, with minimal symptoms and stable haemodynamics [7], it may worsen prognosis [8]. Many of the promoting factors for late VA (occurring>30 days after continuous-flow LVAD implantation) have been well documented [9, 10, 11].

The early postoperative stage (<30 days after LVAD implantation) appears to be a critical time for arrhythmias [4, 6, 12, 13] and may affect up to 39% of patients [4]. Early postimplantation VAs may also increase mortality and decrease transplantation rates [8, 14], but little is known about the incidence of and predictive factors for recurrent sustained VAs [10].

The purpose of this study was to assess the incidence and prognosis of arrhythmic storms occurring within 30 days after LVAD implantation and to identify their risk factors.

Methods
Study population and data collection

All patients undergoing implantation of the HeartMate® II LVAD continuous-flow device (Thoratec Corp., Pleasanton, CA, USA) between January 2008 and December 2014 at our institution were included retrospectively. The HeartMate® II device is a third-generation LVAD, which provides extended circulatory support by continuous unloading of the left ventricle through an axial flow rotary pump, and by delivering blood flow to the ascending aorta (Figure 1).



Figure 1


Figure 1. 

A. HeartMate® II left ventricular assist device. B. Chest X-ray of patient with implantable cardioverter-defibrillator (ICD) and HeartMate® II device.

Zoom

Patients gave their informed consent. The study was conducted in accordance with the ethical principles stated in the Declaration of Helsinki and in adherence with applicable guidelines for good clinical practice. Sociodemographic, clinical and treatment characteristics were collected at baseline by reviewing the electronic medical records (clinical and ultrasound data and implantable cardioverter-defibrillator [ICD] and LVAD logs).

Follow-up and endpoints

Patients were followed up to the end of April 2015. Data were collected using hospital archives and the hospital software for archiving medical data. All relevant hospitalization and consultation reports were examined. If necessary, the referring cardiologist was contacted by telephone.

The primary endpoint was the occurrence of an electrical storm (ES) in the early period (first month) after LVAD implantation. The secondary endpoints were related to the potential risk factors for early ES – history of ventricular tachycardia (VT), aetiology of heart disease (ischaemic or not), presence of ICD, baseline ultrasound variables (left ventricular ejection fraction [LVEF] and left ventricular end-diastolic diameter [LVEDD]) and suction events – and also the overall mortality rate at 30 days and 1 year and the occurrence of interactions between ICDs and LVADs.

Definitions

Sustained VA was defined as any VT or ventricular fibrillation lasting>30seconds. ES was consensually defined as the occurrence of three or more separate episodes of sustained VA within a 24-hour interval.

Statistical analysis

Quantitative continuous variables are expressed as means and standard deviations. Means were compared using Student's t test or the Mann-Whitney test. Categorical variables are described as numbers with corresponding percentages and were compared using Pearson's χ 2 test or Fischer's exact test, as appropriate. Statistical analysis was performed using StatPlus software for Mac (AnalystSoft, Walnut, CA, USA). All P values were two-tailed, with statistical significance set at 0.05.

Results
Population characteristics before HeartMate® II implantation

From January 2008 to December 2014, forty-three consecutive patients (mean age 56.7±11.2 years; 39 men) underwent HeartMate® II implantation at our institution (Table 1). Indications for mechanical assistance were progressive heart failure (n =20, 46.5%), acute cardiogenic shock (n =23, 53.5%; of these, 11 patients experienced ES leading to the LVAD implantation), as a bridge to cardiac transplantation (n =31, 72.1%) or as destination therapy (n =12, 27.9%). The underlying cardiomyopathy was mostly ischaemic (n =32, 74.4%). Ten (23.3%) patients had an idiopathic dilated cardiomyopathy and one (2.3%) patient had an anthracycline-induced cardiomyopathy.

Mean LVEF and mean LVEDD before LVAD implantation were 20±5% and 71±10mm, respectively. Severe right ventricular failure was not reported before surgery.

Twenty (46.5%) patients had previous ICD implantation, for a prophylactic indication (n =16, 80%) or secondary prevention (n =4, 20%), with biventricular resynchronization therapy in 14 (70%), single-chamber pacing in four (20%) and dual-chamber pacing in two (10%).

Seventeen of 20 (85%) patients with chronic heart failure and six of 23 (26%) patients with acute cardiac dysfunction had been treated previously with long-term beta-blocker therapy.

Before HeartMate® II implantation, 13 patients had experienced sustained VA or had been treated for VT (mostly with ICD therapy) and one had a history of ES unrelated to an acute myocardial infarction.

Catheter endocardial ablation of VT was carried out in two patients (4.7%) before the HeartMate® II device implantation. Surgical VT ablation during device implantation was performed in two other patients (4.7%).

Outcome

During a mean follow-up of 18.5±18.5 months, 11 (25.6%) patients underwent cardiac transplantation, two (4.6%) had their device explanted after myocardial recovery of non-ischaemic myocardiopathy (LVEF increased from 20% to 50%) and 26 (60%) died. The median time to death was 8.2 months after LVAD implantation. Seven (16.3%) patients underwent ICD implantation after HeartMate® II placement.

Early ES

Twelve (27.9%) patients (eight with ischaemic myocardiopathy, eight with previous ICD implantation) experienced early ES, with an average time to onset of 9.1±7.8 days after HeartMate® II implantation. Among them, 10 (83.3%) patients experienced ES within the first 15 days after surgery.

Among the 13 patients with a history of sustained or treated VA, six (46.2%) experienced ES within 30 days after LVAD, whereas six (20.0%) patients without a history of VA experienced an early postimplantation ES.

No early ES occurred under beta-blocker therapy. Four (33.3%) patients were still receiving a beta-agonist (norepinephrine) when ES occurred. A suction event in the HeartMate® II log was reported in one patient presenting an early ES; change in turbine speed stopped the arrhythmic storm.

Early ES occurred significantly more frequently in larger patients (weight, 82±13 vs 69±11kg [P =0.01], body surface area, 1.99±0.17 vs 1.81±0.16 m2 [P <0.01]) and tended to be associated with previous symptomatic or treated sustained VT (50% vs 22.6%; P =0.079), previous ICD implantation (66.7% vs 38.7%; P =0.09), discontinuation of beta-blocker therapy (75.0% vs 45.2%; P =0.08), weaning of adrenergic drugs after third day (66.7% vs 35.5%; P =0.06) and the use of extracorporeal life support (50.0% vs 22.6%; P =0.079) (Table 2).

Emergency LVAD implantation for acute cardiogenic shock and the ischaemic aetiology of the cardiomyopathy were not associated with early ES (50% vs 55% [P not significant] and 67% vs 77% [P not significant], respectively).

ES occurring just before LVAD implantation (25% vs 26%; P not significant) was not associated with recurrence of ES.

Six (50.0%) patients required catheter endocardial VT ablation after medical therapeutic failure (amiodarone for all, lidocaine for seven and beta-blockers for three). One patient underwent a second ablation procedure after recurrence (Table 3).

Four patients who had early ES died before the 30th day: refractory ES with myocardial failure (n =2); cerebral haematoma (n =1) and cardiogenic shock despite extracorporeal life support (n =1). Two patients with no early ES died because of refractory cardiac failure.

One patient underwent implantation of a Thoratec® biventricular assist device (Thoratec Corp., Pleasanton, CA, USA) because of right ventricular failure after early ES.

Early ES was associated with a significantly higher mortality rate at the 30th day (33.3% vs 6.5%; P =0.02) (Figure 2). However, the survival rate at 1 year was similar in both groups (50.0% vs 54.8%; P not significant).



Figure 2


Figure 2. 

Early arrhythmic storm and survival at 30th day in population with HeartMate® II left ventricular assist device implantation. LVEF: left ventricular ejection fraction; VT: ventricular arrhythmia; yo: years old.

Zoom

ICD interference with LVAD

Twenty patients had previous ICD implantation before LVAD. Seven patients underwent ICD implantation after LVAD.

Some major problems of electromagnetic interference between the HeartMate® II LVAD and the ICD telemetry, preventing any interrogation or variable setting, were reported in four patients: three with ICD devices by Sorin (Milan, Italy; Ovatio®, Paradym®); and one with an ICD device by St. Jude Medical (St. Paul, MN, USA; Atlas®). Two interferences with Sorin devices led to switching of devices after telemetry failure despite changing the position of the programmer head.

No interference was reported in two patients with ICD devices by Guidant/Boston Scientific (Indianapolis, IN, USA; Teligen®, Vitality®), four patients with ICD devices by Medtronic (Minneapolis, MN, USA; Protecta®, Secura®, Virtuoso®), five patients with ICD devices by Biotronik (Berlin, Germany; Kronos®, Lexos®, Lumax®) and six patients with other ICD devices by St. Jude Medical (Current®, Ellipse®, Epic II® and Fortify®).

That said, LVAD interferences have never been responsible for inappropriate shock.

Discussion

VA storms were frequent in the 30 days after continuous-flow LVAD implantation, occurring in 28% of patients who underwent HeartMate® II implantation, in our series; they were more frequent in larger patients, patients with a history of sustained or treated VA, patients with previous ICD implantation and those who stopped beta-blocker therapy for implantation. VA storms were also associated with higher all-cause mortality at 30 days, but long-term survival was similar in patients with or without VA [15].

VA is frequent with continuous-flow LVAD [9, 10, 15] and remains one of the most common problems after LVAD implantation. The increased occurrence of VA in the early period after LVAD implantation (both with pulsatile and continuous-flow devices) has been well reported in a few studies [3, 4, 10, 13, 15], with incidence rates varying from 13% [13] to 39% [4]. In our study, we reported an incidence of early recurrent VA of 28% after LVAD placement. This rate is similar to that (about 25%) reported in the only prospective study [10], where several rapid-succession episodes of VA within 12 consecutive hours were considered as a single event.

Promoting factors and management of early VA after LVAD implantation

Several predisposing factors for VA after LVAD implantation have been reported. A history of VT has emerged as a particularly powerful predictor of early VA [10, 15]. Our study does not report any association with the aetiology of myocardiopathy, the predisposing character of which has been contested [16]. Non-ischaemic cardiomyopathy has been associated with a higher risk of VA [10], while ischaemic cause has also been reported as a predictor of VA [6, 8].

Apical myocardial scarring at the HeartMate® II inflow cannula could be a predominant substrate for VA [6, 8], but it has not been confirmed in endocardial mapping before VA ablation [17].

In our study, early ES was more frequent in larger patients, suggesting that a lower assisted cardiac index could play a role in the arrhythmia onset.

We also noted that early VA tended to be associated with long-term beta-blocker therapy and with the prolonged use of catecholamines for >3 days after surgery. The promoting role of the autonomic system imbalance in arrhythmia onset in the postoperative period could be incriminating, including beta-blocker weaning and the use of adrenergic medication. It is important to clarify that no early ES occurred under beta-blocker treatment, the late introduction of which promotes VA occurrence [5].

It should also be mentioned that precipitants of early VA events may be different to those of late (>30 days) VA events in patients who have undergone LVAD implantation: electrolyte disorder [10], inflow cannula suction event [18]– which was reported once in our study – and prolonged ventricular repolarization have also been evoked.

Prognosis and VT ablation therapy

Although patients who have undergone LVAD implantation may tolerate sustained VA [12], its occurrence could worsen their prognosis by impairing right ventricular filling, thereby leading to device thrombosis and right ventricular failure [8, 19]. Contrary to the results of a previous study [10], we reported a poorer early outcome in patients with recurrent VA occurring in postoperative period. A meta-analysis of nine observational studies, including 1179 patients who underwent LVAD implantation, also found an increased risk of all-cause mortality with VA after LVAD implantation [16].

Radiofrequency ablation therapy should be considered as an option in case of intractable arrhythmia [17]; it could also be considered before (endocardial and catheter pathway) or during (endocardial and surgical pathway [20]) LVAD placement in identified high-risk VA patients. Such a preventive strategy would merit assessment in a prospective randomized study.

LVAD and ICD incompatibilities caused by electromagnetic interferences have previously been described, particularly with regard to St. Jude Medical and Sorin devices [9, 19]. In our study, two Sorin ICD generators had to be changed, because of the disabling loss of telemetry communication with the programmer.

Study limitations

Our analysis suffers from several methodological limitations. First, this was a retrospective single-centre study, so the results are not generalizable to other LVAD populations (including other devices). Some data (ionic disturbance, repolarization modification) have not been analysed. Moreover, given the relatively limited number of patients, multivariable regression analysis was not performed. In addition, there has been very little reporting about early VA in patients who have undergone LVAD implantation and it is important to collect further and more complete data to improve their diagnostic and therapeutic management.

Conclusions

Recurrent VA or ES was the usual complication early after HeartMate® II implantation, occurring in more than one quarter of patients and worsening their short-term prognosis. Specific studies are required to determine more precisely the promoting factors and to decide on the optimal therapeutic strategy.

Sources of funding

None.

Disclosure of interest

The authors declare that they have no competing interest.

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