Summary
Background
Despite the increased number of implantable cardioverter defibrillator (ICD) recipients and the frequent need for device upgrading and/or occurrence of lead malfunction, the optimal approach to managing abandoned leads remains debated.
Aims
To determine the rate and type of complications related to either abandoned or extracted ICD leads.
Methods
Patients with abandoned or extracted leads were identified retrospectively. Patient medical records were reviewed to assess long-term lead or device malfunction, defibrillation test values before and after lead abandonment or extraction, and appropriateness of delivered shocks and subsequent surgical procedures related to devices or leads.
Results
A total of 58 ICD patients with 47 extracted and 34 abandoned leads were identified. After a mean follow-up of 3.2 ± 2.6 years, the defibrillation test was not affected by either abandoned or extracted leads (23.4 ± 6.6 J vs 25.4 ± 4.9 J, respectively; P = 0.24). There were no differences in the number of ICD-related surgical procedures after extracting versus abandoning leads (22% vs 12%, respectively; P = 0.3) or in the thromboembolic event rate (7.7% vs 6.3%; P = 0.83). During follow-up, no differences in the occurrence of major complications or appropriate/inappropriate shocks were observed between patients with or without abandoned leads.
Conclusion
We observed no difference in rates of immediate or medium-term complications between extracting versus abandoning leads. Lead abandonment remains an alternative and safe option when extraction does not appear mandatory according to the age of the leads or experience of the operating centre.
Résumé
Contexte
Malgré le nombre croissant d’implantations de défibrillateurs automatiques implantables (ICD) et la nécessité fréquente soit d’une optimisation de la prothèse (rajout d’une stimulation gauche), soit en cas de dysfonctionnement de sonde d’en rajouter une nouvelle, la façon de gérer les sondes abandonnées est toujours sujette à controverse.
Objectif
Le but de cette étude est d’évaluer le taux et le type de complications liées à l’option choisie d’abandon ou d’extraction de sondes de défibrillateurs.
Méthodes
Les patients avec des sondes extraites et abandonnées ont été rétrospectivement identifiés et leurs données médicales analysées pour authentifier les dysfonctionnements de sondes, les valeurs de seuils de défibrillation avant et après abandon/extraction, les chocs appropriés et les autres types de complications.
Résultats
Nous avons identifié 58 patients avec 47 extractions et 34 abandons de sondes. Après un suivi moyen de 3,2 ± 2,6 ans, les tests de défibrillation sont restés comparables entre les patients avec sondes abandonnées ou extraites (23,4 ± 6,6 J contre 25,4 ± 4,9 J respectivement, p = 0,24). Aucune différence n’a été notée dans le nombre de procédures chirurgicales entre les sondes extraites et abandonnées (22 % contre 12 %, p = 0,3), ni dans le nombre d’événements thrombo-emboliques (7,7 % contre 6,3 %, p = 0,83). Durant le suivi, aucune différence dans la survenue de complications majeures ou de chocs appropriés et inappropriés n’a été observée entre les deux groupes.
Conclusions
Aucune différence en terme de complications à court et moyen terme entre les deux stratégies d’extraction et d’abandon de sondes de défibrillation n’a été observée. L’abandon de sondes reste une décision raisonnable si l’extraction n’apparaît pas obligatoire, et en fonction de l’âge des sondes et de l’expérience des opérateurs du centre.
Abbreviations
CIED
cardiovascular implantable electronic device
ICD
implantable cardioverter defibrillator
NYHA
New York Heart Association
SCD
sudden cardiac death
SCV
superior cava vein
Background
ICD have been used to treat ventricular arrhythmias since the early 1980s, with an increasing number of implantations performed due to incremental indications in the primary prevention of SCD and in patients with heart failure. Nonetheless, the long-term reliability of endocardial ICD leads is a major and frequent concern, following the report by Kleemann et al. of a 20% annual failure rate for 10-year-old leads.
The best approach for managing non-functioning or malfunctioning leads has not been clearly defined, and is the subject of ongoing debate. Infection of a CIED requires complete removal of the device in order to ensure sterilization of blood cultures. Infection is the most common indication for lead extraction. In fact, a large volume of data exists to show that lead extraction exposes patients to a risk of complications including death (particularly with older leads) ; consequently, lead abandonment is currently considered safer than percutaneous lead extraction when lead removal is not mandatory.
While abandoning rather than extracting ICD leads provides no clinically significant additional risk for future complications, the clinical outcomes for the two options have not been compared directly. Recently, Glikson et al. studied patients with abandoned ICD leads, but did not compare their outcomes with a matched group for whom the leads were extracted. Although the authors reported no additional burden related to the abandoned leads, questions remain about the appropriateness of lead extraction versus abandonment. Extraction, for example, would eliminate the potential for ‘noise’ when an abandoned lead comes into contact with the new lead, and the risk of a high defibrillation threshold caused by energy shunting along the abandoned lead . Lead abandonment may also increase the risk of venous obstruction due to the presence of multiple leads, while extraction itself may cause thromboembolic complications, particularly when extraction is incomplete . Hence, we sought to compare both immediate and long-term risk of complications in patients with abandoned or extracted leads, but without focusing on the reasons for or techniques of extraction.
Methods
Patient population
The study population comprised patients who underwent a second ICD implantation procedure and were subsequently followed in our institution between December 1993 and April 2009. Patient data were systematically registered before implantation. Follow-up was carried out every 6 months. Data on NYHA status and appropriate and inappropriate therapies were collected, and the ICD was checked. Thromboembolic events were diagnosed by phlebography. In most cases, phlebography was performed when a new lead was implanted. Only thromboembolic events that occurred after lead extraction or abandonment were investigated in this analysis.
All procedures during which leads were either abandoned or extracted were identified by retrospective review of the clinical ICD database. In this population, lead extractions were essentially performed for cases of device infection, whereas most non-functioning leads were abandoned. Some leads were either extracted or abandoned (and replaced) because of signs of pre-clinical lead dysfunction, such as acute or progressive impedance or sensing lead drop, and were considered as ‘prophylactic’ extraction or abandonment. Immediate and long-term outcomes were reviewed for minimal effective energy before and after lead abandonment or extraction (during the first and the second procedure, respectively), venous thromboembolic complications, device sensing malfunction, appropriately and inappropriately delivered shocks, and subsequent surgical procedures related to devices or leads. All outcomes, including episodes of delivered shocks, were reviewed systematically and independently by two authors (M.A., A.F.).
Statistical analysis
Data are expressed as mean ± standard deviation (SD), median [interquartile range] or as frequency and percentage. Categorical variables were compared using the Chi-square statistic and continuous variables by the Wilcoxon rank sum test. A P -value < 0.05 was considered as statistically significant.
Results
Patient characteristics
Patient characteristics data are summarized in Table 1 . During the study period, 58 patients were identified in whom a second ICD and lead(s) implantation procedure was carried out. Among these patients, 32 (55%) underwent lead extraction and 26 (45%) had their leads abandoned. Mean age at the time of the second procedure implantation was 58 ± 12 years; all of the patients were male. Most patients had underlying heart disease (ischaemic or non-ischaemic). Mean left ventricular ejection fraction was 34 ± 15%. The initial indication for ICD implantation was primary prevention in 22 (38%) patients and secondary prevention in 36 (62%) patients.
| All patients ( n = 58) | Patients with abandoned leads ( n = 26) | Patients with extracted leads ( n = 32) | P | |
|---|---|---|---|---|
| Age (years) | 58 ± 12 | 62 ± 9 | 55 ± 13 | 0.17 |
| Diabetes | 10 (17) | 6 (23) | 4 (12) | 0.29 |
| Hypertension | 21 (36) | 11 (42) | 10 (31) | 0.38 |
| Type of cardiomyopathy | ||||
| Coronary artery disease | 34 (59) | 16 (62) | 18 (53) | 0.22 |
| Dilated cardiomyopathy | 19 (33) | 9 (33) | 10 (31) | |
| Valvular cardiomyopathy a | 1 (2) | 0 | 1 (3) | |
| Brugada’s syndrome | 4 | 0 | 4 (12) | |
| No heart disease | 1 (2) | 1 (4) | 0 | |
| Left ventricular ejection fraction (%) | 34 ± 15 | 34 ± 14 | 34 ± 16 | 0.56 |
| NYHA status (%) | 0.59 | |||
| Class I | 12 (21) | 4 (15) | 8 (25) | |
| Class II | 33 (57) | 15 (57) | 18 (56) | |
| Class III | 13 (22) | 7 (27) | 6 (19) | |
| Initial indication for implantation | 0.28 | |||
| Primary prevention | 22 (38) | 9 (35) | 13 (40) | |
| Secondary prevention | 36 (62) | 17 (65) | 19 (59) | |
| Pacing indication b | 13 (22) | 8 (31) | 5 (16) | |
| Median date of initial implantation | 4/03/2003 | 13/12/2000 | 24/05/2005 | < 0.0001 |
| Median duration c (months) | 72 (55–96) | 6 (1–30) | < 0.0001 | |
| Average date of reimplantation | 29/11/2006 | 23/08/2006 | 0.72 | |
| Indications for reimplantation | ||||
| Primary prevention | 19 | 18 | 0.49 | |
| Secondary prevention | 26 | 37 |
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