Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Jun 20;81(24):2328-2340.
doi: 10.1016/j.jacc.2023.04.017. Epub 2023 May 18.

Incidence, Treatment, and Outcomes of Symptomatic Device Lead-Related Venous Obstruction

Enrico G Ferro  1 , Daniel B Kramer  1 , Siling Li  2 , Andrew H Locke  3 , Shantum Misra  3 , Alec A Schmaier  3 , Brett J Carroll  1 , Yang Song  2 , Andre A D'Avila  3 , Robert W Yeh  1 , Peter J Zimetbaum  4 , Eric A Secemsky  5
Affiliations

Incidence, Treatment, and Outcomes of Symptomatic Device Lead-Related Venous Obstruction

Enrico G Ferro et al. J Am Coll Cardiol. .

Abstract

Background: The incidence and clinical impact of lead-related venous obstruction (LRVO) among patients with cardiovascular implantable electronic devices (CIEDs) is poorly defined.

Objectives: The objectives of this study were to determine the incidence of symptomatic LRVO after CIED implant; describe patterns in CIED extraction and revascularization; and quantify LRVO-related health care utilization based on each type of intervention.

Methods: LRVO status was defined among Medicare beneficiaries after CIED implant from October 1, 2015, to December 31, 2020. Cumulative incidence functions of LRVO were estimated by Fine-Gray methods. LRVO predictors were identified using Cox regression. Incidence rates for LRVO-related health care visits were calculated with Poisson models.

Results: Among 649,524 patients who underwent CIED implant, 28,214 developed LRVO, with 5.0% cumulative incidence at maximum follow-up of 5.2 years. Independent predictors of LRVO included CIEDs with >1 lead (HR: 1.09; 95% CI: 1.07-1.15), chronic kidney disease (HR: 1.17; 95% CI: 1.14-1.20), and malignancies (HR: 1.23; 95% CI: 1.20-1.27). Most patients with LRVO (85.2%) were managed conservatively. Among 4,186 (14.8%) patients undergoing intervention, 74.0% underwent CIED extraction and 26.0% percutaneous revascularization. Notably, 90% of the patients did not receive another CIED after extraction, with low use (2.2%) of leadless pacemakers. In adjusted models, extraction was associated with significant reductions in LRVO-related health care utilization (adjusted rate ratio: 0.58; 95% CI: 0.52-0.66) compared with conservative management.

Conclusions: In a large nationwide sample, the incidence of LRVO was substantial, affecting 1 of every 20 patients with CIEDs. Device extraction was the most common intervention and was associated with long-term reduction in recurrent health care utilization.

Keywords: Medicare; cardiovascular implantable electronic devices; health care utilization lead extraction; lead-related venous obstruction; percutaneous revascularization.

PubMed Disclaimer

Conflict of interest statement

Funding Support and Author Disclosures Dr Secemsky is supported in part by K23HL150290; and receives consulting fees from Abbott, Bayer, BD, Boston Scientific, Cook, CSI, Medtronic, Philips, Shockwave, and VentureMed. Dr Kramer is supported by R01HL161697 and R01AG068141. Dr Carroll has received institutional research support from Bristol Myers Squibb; and has received consulting fees from Janssen. Dr Yeh has received research funding and consulting fees from Abbott Vascular, Boston Scientific, and Medtronic; and has received research funding from Bard, Cook, and Philips. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Figures

FIGURE 1
FIGURE 1. Prevalence of LRVO Among Patients With CIEDs in the United States
This flowchart describes the creation of the final study cohort after applying all inclusion and exclusion criteria. For example, after applying the exclusion criteria, approximately 650,000 patients were found to have a first-time CIED implant during the study period. CIED = cardiovascular implantable electronic device; CRT = cardiac resynchronization therapy; DVT = deep venous thrombosis; FFS = fee-for-service; LRVO = lead-related venous obstruction.
FIGURE 2
FIGURE 2. Prevalence LRVO-Related Interventions as a Proportion of CIED Volume
This figure describes the relative proportion of different patient subgroups during each calendar quarter of the study period. For example, the blue bar represents the total number of CIEDs implanted per quarter, and the red bar represents the proportion of CIEDs that were leadless or subcutaneous devices during that quarter. The dotted arrow marks the time of FDA approval of the leadless pacemaker, and the square bracket includes the calendar quarters affected by the COVID-19 pandemic. CIED = cardiovascular implantable electronic device; FDA = U.S. Food and Drug Administration; LRVO = lead-related venous obstruction; PPM = permanent pacemaker; SubQ = subcutaneous; Q = quarter of the calendar year.
FIGURE 3
FIGURE 3. Cumulative Incidence Functions of LRVO and LRVO-Related Interventions
Each figure in this panel represents the cumulative incidence function (CIF) of specific patient subgroups. (A) CIF of LRVO development after CIED implant. (B) CIF of CIED extraction, percutaneous revascularization, and venous surgery after LRVO diagnosis. (C) CIF of different types of percutaneous revascularizations, namely balloon venoplasty, thrombolysis, percutaneous stenting, and thrombectomy. Abbreviations as in Figure 2.
CENTRAL ILLUSTRATION
CENTRAL ILLUSTRATION. Natural History of Lead-Related Venous Obstruction Among Medicare Beneficiaries in the United States
This flowchart describes the clinical progression of LRVO among patients who undergo implant of first-time CIED, where the arrows indicate the transition from one group to the next. For example, 15% of LRVO patients subsequently undergo an invasive intervention like percutaneous revascularization or extraction. The pie charts provide the relative percentage of procedural details for each intervention: for example, among patients undergoing extraction, 90% did not receive another CIED. CHB = complete heart block; CIED = cardiovascular implantable electronic device; LRVO = lead-related venous obstruction; PPM = permanent pacemaker; SQ-ICD = subcutaneous intracardiac defibrillator; VT = ventricular tachycardia.
See this image and copyright information in PMC

Comment in

References

    1. Zimetbaum P, Carroll BJ, Locke AH, Secemsky E, Schermerhorn M. Lead-related venous obstruction in patients with implanted cardiac devices: JACC Review Topic of the Week. J Am Coll Cardiol. 2022;79(3):299–308. 10.1016/j.jacc.2021.11.017 - DOI - PubMed
    1. Greenspon AJ, Patel JD, Lau E, et al. Trends in permanent pacemaker implantation in the United States from 1993 to 2009: increasing complexity of patients and procedures. J Am Coll Cardiol. 2012;60(16):1540–1545. 10.1016/j.jacc.2012.07.017 - DOI - PubMed
    1. Duijzer D, de Winter MA, Nijkeuter M, Tuinenburg AE, Westerink J. Upper extremity deep vein thrombosis and asymptomatic vein occlusion in patients with transvenous leads: a systematic review and meta-analysis. Front Cardiovasc Med. 2021;8:698336. 10.3389/fcvm.2021.698336 - DOI - PMC - PubMed
    1. Kusumoto FM, Schoenfeld MH, Wilkoff BL, et al. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm. 2017;14(12):e503–e551. 10.1016/j.hrthm.2017.09.001 - DOI - PubMed
    1. Worley SJ, Gohn DC, Pulliam RW, Raifsnider MA, Ebersole BI, Tuzi J. Subclavian venoplasty by the implanting physicians in 373 patients over 11 years. Heart Rhythm. 2011;8(4):526–533. 10.1016/j.hrthm.2010.12.014 - DOI - PubMed

Publication types