Ten-Year Clinical Experience with the Lumenless, Catheter-Delivered, 4.1-Fr Diameter Pacing Lead in Patients with and without Congenital Heart

Neha Bansal, Sharmeen Samuel, Kathleen Zelin, Peter P. Karpawich

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background: Patients with congenital heart defects (CHD) often present more challenges to pacing therapy due to anatomy than those without CHD. The lumenless, 4.1Fr diameter M3830 pacing lead (Medtronic, Inc., Minneapolis, MN, USA), approved for use in 2005, has, to date, reported to have excellent short-term (<6 years) lead performance. Unfortunately, very long-term performance is unknown, especially among CHD patients and with implants at alternate pacing (AP) sites. This study reports a 10-year clinical experience with the M3830 lead. Methods: Records of patients who received the M3830 lead were reviewed: patient demographics, implant techniques and locations, sensing and pacing characteristics, impedances (Imp), and any complications at implant and follow-up. Results: From 2005 to 2015, 141 patients (ages 2–50, mean 20.1 years, 57% males) received 212 leads: atrial 115; ventricle 97. CHD was present in 62% of patients. Leads were inserted at AP sites in 96% of patients. Postimplant follow-up was from 3 months to 10 years (mean 56.3 months). Comparative implant versus follow-up values (mean ± standard deviation) were available on 196 leads (92.5%), showing persistently low (<1 v @ 0.4–0.5 ms) pacing thresholds (P = 0.57). Sensing was also comparable (atrial leads, P = 0.41; ventricular leads, P = 0.9). Impedances differed (P < 0.05) but remained within the normal range. Two A leads became dislodged and one was repositioned while two other leads (1 A, 1 V) were extracted. There are no differences observed in the pacing characteristics between the CHD and non-CHD groups on follow-up. Conclusions: The 4.1Fr lumenless pacing lead shows ease of implant regardless of CHD or AP site, excellent very long-term (10 years) stability, and performance indices with a very low rate of complications.

Original languageEnglish (US)
Pages (from-to)17-25
Number of pages9
JournalPACE - Pacing and Clinical Electrophysiology
Volume40
Issue number1
DOIs
StatePublished - Jan 1 2017
Externally publishedYes

Fingerprint

Congenital Heart Defects
Catheters
Electric Impedance
Lead
Anatomy
Reference Values
Demography

Keywords

  • congenital heart defect
  • lumenless pacing lead
  • pacing
  • pediatrics

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Ten-Year Clinical Experience with the Lumenless, Catheter-Delivered, 4.1-Fr Diameter Pacing Lead in Patients with and without Congenital Heart. / Bansal, Neha; Samuel, Sharmeen; Zelin, Kathleen; Karpawich, Peter P.

In: PACE - Pacing and Clinical Electrophysiology, Vol. 40, No. 1, 01.01.2017, p. 17-25.

Research output: Contribution to journalArticle

@article{24334b915c054c8a9282c6fcfeda2454,
title = "Ten-Year Clinical Experience with the Lumenless, Catheter-Delivered, 4.1-Fr Diameter Pacing Lead in Patients with and without Congenital Heart",
abstract = "Background: Patients with congenital heart defects (CHD) often present more challenges to pacing therapy due to anatomy than those without CHD. The lumenless, 4.1Fr diameter M3830 pacing lead (Medtronic, Inc., Minneapolis, MN, USA), approved for use in 2005, has, to date, reported to have excellent short-term (<6 years) lead performance. Unfortunately, very long-term performance is unknown, especially among CHD patients and with implants at alternate pacing (AP) sites. This study reports a 10-year clinical experience with the M3830 lead. Methods: Records of patients who received the M3830 lead were reviewed: patient demographics, implant techniques and locations, sensing and pacing characteristics, impedances (Imp), and any complications at implant and follow-up. Results: From 2005 to 2015, 141 patients (ages 2–50, mean 20.1 years, 57{\%} males) received 212 leads: atrial 115; ventricle 97. CHD was present in 62{\%} of patients. Leads were inserted at AP sites in 96{\%} of patients. Postimplant follow-up was from 3 months to 10 years (mean 56.3 months). Comparative implant versus follow-up values (mean ± standard deviation) were available on 196 leads (92.5{\%}), showing persistently low (<1 v @ 0.4–0.5 ms) pacing thresholds (P = 0.57). Sensing was also comparable (atrial leads, P = 0.41; ventricular leads, P = 0.9). Impedances differed (P < 0.05) but remained within the normal range. Two A leads became dislodged and one was repositioned while two other leads (1 A, 1 V) were extracted. There are no differences observed in the pacing characteristics between the CHD and non-CHD groups on follow-up. Conclusions: The 4.1Fr lumenless pacing lead shows ease of implant regardless of CHD or AP site, excellent very long-term (10 years) stability, and performance indices with a very low rate of complications.",
keywords = "congenital heart defect, lumenless pacing lead, pacing, pediatrics",
author = "Neha Bansal and Sharmeen Samuel and Kathleen Zelin and Karpawich, {Peter P.}",
year = "2017",
month = "1",
day = "1",
doi = "10.1111/pace.12995",
language = "English (US)",
volume = "40",
pages = "17--25",
journal = "PACE - Pacing and Clinical Electrophysiology",
issn = "0147-8389",
publisher = "Wiley-Blackwell",
number = "1",

}

TY - JOUR

T1 - Ten-Year Clinical Experience with the Lumenless, Catheter-Delivered, 4.1-Fr Diameter Pacing Lead in Patients with and without Congenital Heart

AU - Bansal, Neha

AU - Samuel, Sharmeen

AU - Zelin, Kathleen

AU - Karpawich, Peter P.

PY - 2017/1/1

Y1 - 2017/1/1

N2 - Background: Patients with congenital heart defects (CHD) often present more challenges to pacing therapy due to anatomy than those without CHD. The lumenless, 4.1Fr diameter M3830 pacing lead (Medtronic, Inc., Minneapolis, MN, USA), approved for use in 2005, has, to date, reported to have excellent short-term (<6 years) lead performance. Unfortunately, very long-term performance is unknown, especially among CHD patients and with implants at alternate pacing (AP) sites. This study reports a 10-year clinical experience with the M3830 lead. Methods: Records of patients who received the M3830 lead were reviewed: patient demographics, implant techniques and locations, sensing and pacing characteristics, impedances (Imp), and any complications at implant and follow-up. Results: From 2005 to 2015, 141 patients (ages 2–50, mean 20.1 years, 57% males) received 212 leads: atrial 115; ventricle 97. CHD was present in 62% of patients. Leads were inserted at AP sites in 96% of patients. Postimplant follow-up was from 3 months to 10 years (mean 56.3 months). Comparative implant versus follow-up values (mean ± standard deviation) were available on 196 leads (92.5%), showing persistently low (<1 v @ 0.4–0.5 ms) pacing thresholds (P = 0.57). Sensing was also comparable (atrial leads, P = 0.41; ventricular leads, P = 0.9). Impedances differed (P < 0.05) but remained within the normal range. Two A leads became dislodged and one was repositioned while two other leads (1 A, 1 V) were extracted. There are no differences observed in the pacing characteristics between the CHD and non-CHD groups on follow-up. Conclusions: The 4.1Fr lumenless pacing lead shows ease of implant regardless of CHD or AP site, excellent very long-term (10 years) stability, and performance indices with a very low rate of complications.

AB - Background: Patients with congenital heart defects (CHD) often present more challenges to pacing therapy due to anatomy than those without CHD. The lumenless, 4.1Fr diameter M3830 pacing lead (Medtronic, Inc., Minneapolis, MN, USA), approved for use in 2005, has, to date, reported to have excellent short-term (<6 years) lead performance. Unfortunately, very long-term performance is unknown, especially among CHD patients and with implants at alternate pacing (AP) sites. This study reports a 10-year clinical experience with the M3830 lead. Methods: Records of patients who received the M3830 lead were reviewed: patient demographics, implant techniques and locations, sensing and pacing characteristics, impedances (Imp), and any complications at implant and follow-up. Results: From 2005 to 2015, 141 patients (ages 2–50, mean 20.1 years, 57% males) received 212 leads: atrial 115; ventricle 97. CHD was present in 62% of patients. Leads were inserted at AP sites in 96% of patients. Postimplant follow-up was from 3 months to 10 years (mean 56.3 months). Comparative implant versus follow-up values (mean ± standard deviation) were available on 196 leads (92.5%), showing persistently low (<1 v @ 0.4–0.5 ms) pacing thresholds (P = 0.57). Sensing was also comparable (atrial leads, P = 0.41; ventricular leads, P = 0.9). Impedances differed (P < 0.05) but remained within the normal range. Two A leads became dislodged and one was repositioned while two other leads (1 A, 1 V) were extracted. There are no differences observed in the pacing characteristics between the CHD and non-CHD groups on follow-up. Conclusions: The 4.1Fr lumenless pacing lead shows ease of implant regardless of CHD or AP site, excellent very long-term (10 years) stability, and performance indices with a very low rate of complications.

KW - congenital heart defect

KW - lumenless pacing lead

KW - pacing

KW - pediatrics

UR - http://www.scopus.com/inward/record.url?scp=85010635813&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85010635813&partnerID=8YFLogxK

U2 - 10.1111/pace.12995

DO - 10.1111/pace.12995

M3 - Article

C2 - 28004408

AN - SCOPUS:85010635813

VL - 40

SP - 17

EP - 25

JO - PACE - Pacing and Clinical Electrophysiology

JF - PACE - Pacing and Clinical Electrophysiology

SN - 0147-8389

IS - 1

ER -