Clinical trial NCT00335036: Pediatric Lead Extractability and Survival Evaluation (PLEASE)
Official title: Pediatric Lead Extractability and Survival Evaluation (PLEASE)Study: A Prospective Assessment of Implantable Cardioverter Defibrillator (ICD) Lead Extractability and Survival in Children and Congenital Heart Disease Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ventricular Tachycardia
Ventricular Fibrillation
Cardiomyopathy
Long QT Syndrome
Congenital Heart Disease
Keywords: Implantable Cardioverter Defibrillator
Ventricular Arrhythmia
Sudden Cardiac Death
Congenital Heart Disease
Pediatric Electrophysiology
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: Medtronic
name: Guidant Corporation
First posted: 2006-06-08
Enrollment: 55
Sex: ALL
Minimum age (years): 1
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, prospective clinical trial comparing 2 different types of implantable cardioverter defibrillator (ICD) leads in children and patients with congenital heart disease. ICD lead survival in this patient group is particularly suboptimal, and lead extraction is technically difficult and carries a substantial morbidity risk. Recently, improved ICD lead designs have been released and are currently being utilized in patients. The main aim of the study is to determine if either type of lead performs better in terms of implantation electrical characteristics, long-term survival without breaking, and ease of extractability.

Detailed description: The recognition that ICD therapy in children can be life-saving, as well as the development of smaller devices and leads, are resulting in increased ICD implantation in the pediatric and young adult populations. However, ICD lead survival in this patient group is suboptimal. Lead extraction is technically difficult and has substantial morbidity. Recently, improved ICD lead designs have been released and are currently being utilized. While the development of transvenous ICD leads has allowed for less invasive implantation, the long-term presence of these leads carries some risks. When a lead becomes infected or causes patient morbidity, it must be removed. Because of the larger caliber of ICD leads and the presence of uninsulated shocking coils, non-functional ICD leads usually warrant removal to avoid future mechanical or electrical lead interactions. The larger size of ICD leads is of concern in this younger population, particularly with regard to avoiding the accumulation of implanted hardware. The principal indication for lead revision in children and young adults is lead malfunction, commonly related to patient growth and increased physical activity in this younger population. The removal of chronic indwelling pacer or ICD leads is not trivial. Scar tissue begins to bind transvenous leads to the endothelial surface several weeks after implantation, and this fibrous adherence progresses over time, exacerbated by high-energy shock delivery. In children and younger adult ICD recipients, exuberant lead scarring is prevalent, particularly in the regions of venous entry, high voltage shocking coils, and the lead tip. Transvenous lead extraction has been facilitated by the use of telescoping sheaths and powered sheaths that can be advanced over the lead to disrupt scar tissue and free the lead from the endothelium.

The 2 ICD lead types to be compared (thin ICD leads versus ePTFE-coated leads) in the proposed study are at clinical equipoise. Both types are believed to be improved over prior generation ICD leads. However, a direct comparison has not been performed. As the pediatric and congenital heart disease patient subgroup is younger than the average ICD patient population, they will have greater likelihood of long-term survival, and therefore, the issues of lead survival, durability, and extractability are critically important. While these themes are important for all ICD patients, they are particularly germane for younger patients who have more active lifestyles and are, in general, expected to outlive their ICD leads.

This study will prospectively assess the improvements in ICD lead design, specifically comparing a Gore ePTFE coating and thinner caliber ICD leads in pediatric and congenital heart disease population.

Specific Aim #1: To prospectively evaluate the long-term performance of modern-generation ICD leads in pediatric and congenital heart disease patients.

Specific Aim #2: To determine the potential beneficial effects of two improvements in ICD lead design - Gore ePTFE coil coating and thinner lead diameter in pediatric and congenital heart disease patients.

Specific Aim #3: To directly compare the safety and efficacy of these new ICD lead technologies in terms of extractability in pediatric and congenital heart disease patients.

The primary hypothesis is that improved lead designs and smaller diameter leads will demonstrate benefit in survival and extractability. The primary outcome variables will include: a) ICD lead functionality and performance by subtype, b) inappropriate shocks due to lead issues, c) lead extractability by subtype (Gore-coated versus thin leads).

Secondary outcomes include comparison of implant electrical parameters, patient morbidity and mortality, comparing each new lead type with each other and against historical pediatric controls with standard transvenous ICD leads.

Eligibility criteria: Inclusion Criteria:

* Patients will be eligible for study enrollment at the time of implantation of a new ICD and transvenous ICD lead.
* All patients under the age of 21 years at the time of initial ICD implantation, or those patients with congenital heart disease and an indication for ICD implantation are eligible for participation.

Exclusion Criteria:

* Patients who have existing ICD leads in place.
* Patients with expected survival less than 1 year.
* Patients who cannot be expected to participate in follow-up visits.
* Patients receiving an epicardial or subcutaneous ICD (without transvenous ICD lead).

Primary outcomes:
measure: ICD lead functionality and performance by subtype
timeFrame: 5 years
measure: Lead extractability by subtype
timeFrame: 5 years
Secondary outcomes:
measure: Comparison of implant electrical parameters
timeFrame: 5 years
measure: Patient morbidity and mortality
timeFrame: 5 years
measure: Comparing each new lead type with each other and against historical pediatric controls with standard transvenous ICD leads
timeFrame: 5 years
measure: Comparison of inappropriate shocks
timeFrame: 5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Charles I Berul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alexander ME, Cecchin F, Walsh EP, Triedman JK, Bevilacqua LM, Berul CI. Implications of implantable cardioverter defibrillator therapy in congenital heart disease and pediatrics. J Cardiovasc Electrophysiol. 2004 Jan;15(1):72-6. doi: 10.1046/j.1540-8167.2004.03388.x.
citation: Stephenson EA, Batra AS, Knilans TK, Gow RM, Gradaus R, Balaji S, Dubin AM, Rhee EK, Ro PS, Thogersen AM, Cecchin F, Triedman JK, Walsh EP, Berul CI. A multicenter experience with novel implantable cardioverter defibrillator configurations in the pediatric and congenital heart disease population. J Cardiovasc Electrophysiol. 2006 Jan;17(1):41-6. doi: 10.1111/j.1540-8167.2005.00271.x.
citation: Cooper JM, Stephenson EA, Berul CI, Walsh EP, Epstein LM. Implantable cardioverter defibrillator lead complications and laser extraction in children and young adults with congenital heart disease: implications for implantation and management. J Cardiovasc Electrophysiol. 2003 Apr;14(4):344-9. doi: 10.1046/j.1540-8167.2003.02500.x.
citation: Link MS, Hill SL, Cliff DL, Swygman CA, Foote CB, Homoud MK, Wang PJ, Estes NA 3rd, Berul CI. Comparison of frequency of complications of implantable cardioverter-defibrillators in children versus adults. Am J Cardiol. 1999 Jan 15;83(2):263-6, A5-6. doi: 10.1016/s0002-9149(98)00834-0.
citation: Atallah J, Erickson CC, Cecchin F, Dubin AM, Law IH, Cohen MI, Lapage MJ, Cannon BC, Chun TU, Freedenberg V, Gierdalski M, Berul CI; Pediatric and Congenital Electrophysiology Society (PACES). Multi-institutional study of implantable defibrillator lead performance in children and young adults: results of the Pediatric Lead Extractability and Survival Evaluation (PLEASE) study. Circulation. 2013 Jun 18;127(24):2393-402. doi: 10.1161/CIRCULATIONAHA.112.001120. Epub 2013 May 21.