Morbidity and mortality in patients precluded for transvenous pacemaker implantation: Experience with a leadless pacemaker

Aatish Garg; Jayanthi N. Koneru; Dedra H. Fagan; Kurt Stromberg; Santosh K. Padala; Mikhael F. El-Chami; Paul R. Roberts; Jonathan P. Piccini; Alan Cheng; Kenneth A. Ellenbogen

doi:10.1016/j.hrthm.2020.07.035

Morbidity and mortality in patients precluded for transvenous pacemaker implantation: Experience with a leadless pacemaker

Aatish Garg, Jayanthi N. Koneru, Dedra H. Fagan, Kurt Stromberg, Santosh K. Padala, Mikhael F. El-Chami, Paul R. Roberts, Jonathan P. Piccini, Alan Cheng, Kenneth A. Ellenbogen

Research output: Contribution to journal › Article › peer-review

2 Scopus citations

Abstract

Background: The Micra transcatheter pacemaker is a safe and effective alternative to transvenous permanent pacemakers (TV-PPMs). However, the safety profile and mortality outcomes of Micra implantation in patients deemed poor candidates for TV-PPM are incompletely understood. Objective: The purpose of this study was to evaluate safety and all-cause mortality in patients undergoing Micra implantation stratified by whether they were precluded for therapy with a TV-PPM. Methods: Patients from the Micra clinical trials were divided into groups on the basis of whether the implanter considered the patient to be precluded from receiving a TV-PPM. Micra groups were compared with one another as well as with a historical cohort of patients who received a single-chamber TV-PPM. Results: A total of 2817 patients underwent a Micra implantation attempt, of whom 546 (19%) patients deemed ineligible for TV-PPM implantation for reasons such as venous access issues or prior device infections. Both acute mortality (2.75% vs 1.32%; P=.022) and total mortality at 36 months (38.1% vs 20.6%; P<.001) were significantly higher in the precluded group than in the nonprecluded group. Mortality was similar among nonprecluded patients and patients implanted with a TV-PPM. The major complication rate through 36 months was similar between the 2 Micra groups (3.81% vs 4.30%; P=.40). Conclusion: All-cause mortality is higher in Micra patients deemed ineligible for TV-PPM implantation than in nonprecluded Micra patients and those who received a TV-PPM, in part related to a higher incidence of chronic comorbidities in these patients. The overall major complication rate was low and did not differ by preclusion status. Clinical Trial Registration: Micra Post-Approval Registry ClinicalTrials.gov identifier: NCT02536118; Micra Continued Access Study ClinicalTrials.gov identifier: NCT02488681; Micra Transcatheter Pacing Study ClinicalTrials.gov identifier: NCT02004873; Medtronic Product Surveillance Registry ClinicalTrials.gov identifier: NCT01524276.

Original language	English (US)
Pages (from-to)	2056-2063
Number of pages	8
Journal	Heart Rhythm
Volume	17
Issue number	12
DOIs	https://doi.org/10.1016/j.hrthm.2020.07.035
State	Published - Dec 2020
Externally published	Yes

Keywords

Clinical trials
Leadless pacemaker
Micra VR
Pacemaker complications
Transvenous pacemaker

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine
Physiology (medical)

Access to Document

10.1016/j.hrthm.2020.07.035

Cite this

@article{81533a920ca34af9be84db67d731b1bb,

title = "Morbidity and mortality in patients precluded for transvenous pacemaker implantation: Experience with a leadless pacemaker",

abstract = "Background: The Micra transcatheter pacemaker is a safe and effective alternative to transvenous permanent pacemakers (TV-PPMs). However, the safety profile and mortality outcomes of Micra implantation in patients deemed poor candidates for TV-PPM are incompletely understood. Objective: The purpose of this study was to evaluate safety and all-cause mortality in patients undergoing Micra implantation stratified by whether they were precluded for therapy with a TV-PPM. Methods: Patients from the Micra clinical trials were divided into groups on the basis of whether the implanter considered the patient to be precluded from receiving a TV-PPM. Micra groups were compared with one another as well as with a historical cohort of patients who received a single-chamber TV-PPM. Results: A total of 2817 patients underwent a Micra implantation attempt, of whom 546 (19%) patients deemed ineligible for TV-PPM implantation for reasons such as venous access issues or prior device infections. Both acute mortality (2.75% vs 1.32%; P=.022) and total mortality at 36 months (38.1% vs 20.6%; P<.001) were significantly higher in the precluded group than in the nonprecluded group. Mortality was similar among nonprecluded patients and patients implanted with a TV-PPM. The major complication rate through 36 months was similar between the 2 Micra groups (3.81% vs 4.30%; P=.40). Conclusion: All-cause mortality is higher in Micra patients deemed ineligible for TV-PPM implantation than in nonprecluded Micra patients and those who received a TV-PPM, in part related to a higher incidence of chronic comorbidities in these patients. The overall major complication rate was low and did not differ by preclusion status. Clinical Trial Registration: Micra Post-Approval Registry ClinicalTrials.gov identifier: NCT02536118; Micra Continued Access Study ClinicalTrials.gov identifier: NCT02488681; Micra Transcatheter Pacing Study ClinicalTrials.gov identifier: NCT02004873; Medtronic Product Surveillance Registry ClinicalTrials.gov identifier: NCT01524276.",

keywords = "Clinical trials, Leadless pacemaker, Micra VR, Pacemaker complications, Transvenous pacemaker",

author = "Aatish Garg and Koneru, {Jayanthi N.} and Fagan, {Dedra H.} and Kurt Stromberg and Padala, {Santosh K.} and El-Chami, {Mikhael F.} and Roberts, {Paul R.} and Piccini, {Jonathan P.} and Alan Cheng and Ellenbogen, {Kenneth A.}",

note = "Funding Information: Dr Koneru has received honoraria from Medtronic and Biotronik and fellowship support from Boston Scientific, Biosense Webster, Medtronic, and Abbott Medical. Dr Fagan is an employee and shareholder of Medtronic. Dr Stromberg is an employee and shareholder of Medtronic. Dr Padala serves as a consultant to Medtronic. Dr El-Chami serves as a consultant to Medtronic, Boston Scientific, and Biotronik. Dr Roberts has received honoraria from Medtronic and Boston Scientific. Dr Piccini has been supported by R01HL128595 from the National Heart, Lung and Blood Institute; he has received grants for clinical research from Abbott, American Heart Association, the Association for the Advancement of Medical Instrumentation, Bayer, Boston Scientific, and Phillips and serves as a consultant to Abbott, Allergan, ARCA Biopharma, Biotronik, Boston Scientific, LivaNova, Medtronic, Milestone, Myokardia, Sanofi, and Phillips. Dr Cheng is an employee and shareholder of Medtronic. Dr Ellenbogen serves as a consultant to Abbott, Biotronik, Boston Scientific, Medtronic, and Biosense Webster. Dr Garg reports no conflicts of interest. Publisher Copyright: {\textcopyright} 2020 Heart Rhythm Society",

year = "2020",

month = dec,

doi = "10.1016/j.hrthm.2020.07.035",

language = "English (US)",

volume = "17",

pages = "2056--2063",

journal = "Heart Rhythm",

issn = "1547-5271",

publisher = "Elsevier",

number = "12",

}

TY - JOUR

T1 - Morbidity and mortality in patients precluded for transvenous pacemaker implantation

T2 - Experience with a leadless pacemaker

AU - Garg, Aatish

AU - Koneru, Jayanthi N.

AU - Fagan, Dedra H.

AU - Stromberg, Kurt

AU - Padala, Santosh K.

AU - El-Chami, Mikhael F.

AU - Roberts, Paul R.

AU - Piccini, Jonathan P.

AU - Cheng, Alan

AU - Ellenbogen, Kenneth A.

N1 - Funding Information: Dr Koneru has received honoraria from Medtronic and Biotronik and fellowship support from Boston Scientific, Biosense Webster, Medtronic, and Abbott Medical. Dr Fagan is an employee and shareholder of Medtronic. Dr Stromberg is an employee and shareholder of Medtronic. Dr Padala serves as a consultant to Medtronic. Dr El-Chami serves as a consultant to Medtronic, Boston Scientific, and Biotronik. Dr Roberts has received honoraria from Medtronic and Boston Scientific. Dr Piccini has been supported by R01HL128595 from the National Heart, Lung and Blood Institute; he has received grants for clinical research from Abbott, American Heart Association, the Association for the Advancement of Medical Instrumentation, Bayer, Boston Scientific, and Phillips and serves as a consultant to Abbott, Allergan, ARCA Biopharma, Biotronik, Boston Scientific, LivaNova, Medtronic, Milestone, Myokardia, Sanofi, and Phillips. Dr Cheng is an employee and shareholder of Medtronic. Dr Ellenbogen serves as a consultant to Abbott, Biotronik, Boston Scientific, Medtronic, and Biosense Webster. Dr Garg reports no conflicts of interest. Publisher Copyright: © 2020 Heart Rhythm Society

PY - 2020/12

Y1 - 2020/12

N2 - Background: The Micra transcatheter pacemaker is a safe and effective alternative to transvenous permanent pacemakers (TV-PPMs). However, the safety profile and mortality outcomes of Micra implantation in patients deemed poor candidates for TV-PPM are incompletely understood. Objective: The purpose of this study was to evaluate safety and all-cause mortality in patients undergoing Micra implantation stratified by whether they were precluded for therapy with a TV-PPM. Methods: Patients from the Micra clinical trials were divided into groups on the basis of whether the implanter considered the patient to be precluded from receiving a TV-PPM. Micra groups were compared with one another as well as with a historical cohort of patients who received a single-chamber TV-PPM. Results: A total of 2817 patients underwent a Micra implantation attempt, of whom 546 (19%) patients deemed ineligible for TV-PPM implantation for reasons such as venous access issues or prior device infections. Both acute mortality (2.75% vs 1.32%; P=.022) and total mortality at 36 months (38.1% vs 20.6%; P<.001) were significantly higher in the precluded group than in the nonprecluded group. Mortality was similar among nonprecluded patients and patients implanted with a TV-PPM. The major complication rate through 36 months was similar between the 2 Micra groups (3.81% vs 4.30%; P=.40). Conclusion: All-cause mortality is higher in Micra patients deemed ineligible for TV-PPM implantation than in nonprecluded Micra patients and those who received a TV-PPM, in part related to a higher incidence of chronic comorbidities in these patients. The overall major complication rate was low and did not differ by preclusion status. Clinical Trial Registration: Micra Post-Approval Registry ClinicalTrials.gov identifier: NCT02536118; Micra Continued Access Study ClinicalTrials.gov identifier: NCT02488681; Micra Transcatheter Pacing Study ClinicalTrials.gov identifier: NCT02004873; Medtronic Product Surveillance Registry ClinicalTrials.gov identifier: NCT01524276.

AB - Background: The Micra transcatheter pacemaker is a safe and effective alternative to transvenous permanent pacemakers (TV-PPMs). However, the safety profile and mortality outcomes of Micra implantation in patients deemed poor candidates for TV-PPM are incompletely understood. Objective: The purpose of this study was to evaluate safety and all-cause mortality in patients undergoing Micra implantation stratified by whether they were precluded for therapy with a TV-PPM. Methods: Patients from the Micra clinical trials were divided into groups on the basis of whether the implanter considered the patient to be precluded from receiving a TV-PPM. Micra groups were compared with one another as well as with a historical cohort of patients who received a single-chamber TV-PPM. Results: A total of 2817 patients underwent a Micra implantation attempt, of whom 546 (19%) patients deemed ineligible for TV-PPM implantation for reasons such as venous access issues or prior device infections. Both acute mortality (2.75% vs 1.32%; P=.022) and total mortality at 36 months (38.1% vs 20.6%; P<.001) were significantly higher in the precluded group than in the nonprecluded group. Mortality was similar among nonprecluded patients and patients implanted with a TV-PPM. The major complication rate through 36 months was similar between the 2 Micra groups (3.81% vs 4.30%; P=.40). Conclusion: All-cause mortality is higher in Micra patients deemed ineligible for TV-PPM implantation than in nonprecluded Micra patients and those who received a TV-PPM, in part related to a higher incidence of chronic comorbidities in these patients. The overall major complication rate was low and did not differ by preclusion status. Clinical Trial Registration: Micra Post-Approval Registry ClinicalTrials.gov identifier: NCT02536118; Micra Continued Access Study ClinicalTrials.gov identifier: NCT02488681; Micra Transcatheter Pacing Study ClinicalTrials.gov identifier: NCT02004873; Medtronic Product Surveillance Registry ClinicalTrials.gov identifier: NCT01524276.

KW - Clinical trials

KW - Leadless pacemaker

KW - Micra VR

KW - Pacemaker complications

KW - Transvenous pacemaker

UR - http://www.scopus.com/inward/record.url?scp=85091538096&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85091538096&partnerID=8YFLogxK

U2 - 10.1016/j.hrthm.2020.07.035

DO - 10.1016/j.hrthm.2020.07.035

M3 - Article

C2 - 32763431

AN - SCOPUS:85091538096

SN - 1547-5271

VL - 17

SP - 2056

EP - 2063

JO - Heart Rhythm

JF - Heart Rhythm

IS - 12

ER -

Morbidity and mortality in patients precluded for transvenous pacemaker implantation: Experience with a leadless pacemaker

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this