An implantable left atrial pressure sensor lead designed for percutaneous extraction using standard techniques

Abstract

Background: An implantable left atrial pressure (LAP) monitoring system for guiding the management of patients with advanced heart failure has the potential to require extraction, particularly in the setting of infection. The LAP sensor lead was designed to be suitable for ease of percutaneous extraction using standard techniques for extracting pacemaker and defibrillator leads. The clinical experience, to date, with percutaneous extraction of the LAP sensor lead is presented.

Methods: A total of 82 patients underwent successful implantation of the LAP sensor lead using transseptal catheterization. Five patients of the 82 patients during a cumulative follow-up period of 267 patient-years (median of 2.9 years/patient) underwent percutaneous extraction using manual traction with a locking stylet and/or an excimer laser sheath to bore through adhesions. The distal fixation anchors of the LAP sensor lead are designed to fold forward during extraction so that the sensor module can easily separate from the interatrial septum.

Results: Percutaneous extraction of the LAP sensor lead was accomplished successfully in all five patients with no embolic events, vascular tears, perforations, or other complications requiring surgical intervention. Manual traction alone was sufficient to detach the LAP sensor lead from the interatrial septum in all cases. Use of the excimer laser sheath was needed in selected cases to bore through scar tissue within the venous insertion site, but not within the heart.

Conclusions: The extraction of the LAP sensor lead was accomplished safely using standard techniques and equipment for percutaneously extracting pacemaker and defibrillator leads.

Trial registration: ClinicalTrials.gov NCT00547729.

©2013, The Authors. Journal compilation ©2013 Wiley Periodicals, Inc.

Figures

Figure 1

(A) Illustration of distal tip of the implantable LAP sensor lead showing sensor module with fixation anchors. (B) Illustration of a longitudinal cross section of the sensor module fixated to the interatrial septum with distal fixation anchors covered with tissue and flush with septum. (C) Illustration of a longitudinal cross-section of the sensor module being retracted from the interatrial septum during extraction and causing the distal fixation anchors to fold forward.

Figure 2

Scout film of chest and abdominal computed tomography scan demonstrating the placement of the ISL and concomitantly implanted pacemaker and defibrillator leads.

Figure 3

(A) Fluoroscopy image showing manual traction being applied to ISL with a locking stylet via the femoral vein using the inferior approach. (B) TEE image showing reverse tenting while traction is being applied to the ISL. (C) TEE image showing the absence of a residual atrial septal defect immediately following ISL extraction. ISL = implantable sensor lead; LA = left atrium; RA = right atrium; TEE = transesophageal echocardiography.

Figure 4

Photographs of the interatrial septum taken from the right side (A) and left side (B) of the septum immediately following percutaneous extraction of the ISL from a canine that was implanted with the ISL for a period of 572 days. Extraction from the septum was performed using the locking stylet alone. The neoendocardial tissue capsule is seen to remain intact over the implant site. CS = coronary sinus; ISL = implantable sensor lead.

Figure 5

Photographs of the interatrial septum taken from the right side (A) and left side (B) of the septum 28 days following percutaneous extraction of the ISL from a canine that was implanted with the ISL for a period of 723 days. Extraction from the septum was performed using both the locking stylet and the excimer laser sheath. No residual septal defect could be identified at 28 days following extraction on intracardiac echocardiography evaluation and on gross anatomical examination A small amount of scar tissue was found to be adherent to the sensor module following extraction (C). CS = coronary sinus; ISL = implantable sensor lead.