-
Something wrong with this record ?
Worldwide Chronic Retrieval Experience of Helix-Fixation Leadless Cardiac Pacemakers
P. Neuzil, DV. Exner, RE. Knops, DJ. Cantillon, P. Defaye, R. Banker, P. Friedman, C. Hubbard, SM. Delgado, A. Bulusu, VY. Reddy
Language English Country United States
Document type Journal Article, Multicenter Study
- MeSH
- Equipment Design MeSH
- Adult MeSH
- Pacemaker, Artificial * MeSH
- Middle Aged MeSH
- Humans MeSH
- Device Removal * methods MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
BACKGROUND: The growing use of leadless pacemaker (LP) technology requires safe and effective solutions for retrieving and removing these devices over the long term. OBJECTIVES: This study sought to evaluate retrieval and removal of an active helix-fixation LP studied in worldwide regulatory clinical trials. METHODS: Subjects enrolled in the LEADLESS II phase 1 investigational device exemption, LEADLESS Observational, or LEADLESS Japan trials with an attempted LP retrieval at least 6 weeks postimplantation were included. The retrieval success rate was evaluated for all attempted retrievals. Site-reported complications associated with LP retrievals were quantified, with the severity and relationship adjudicated by an independent clinical events committee. RESULTS: There were 1,423 successful LP implants and 234 chronic LP retrieval attempts in 233 subjects. The overall retrieval success rate was 87.6% (205 of 234 attempts). The most common reason for failed retrieval (86.2%, 25 of 29 attempts) was inability to access the LP docking button. The mean time from implantation to attempted retrieval was 3.2 years (range 0.2-9.0 years) and did not significantly influence the retrieval success (P = 0.71). The clinical events committee adjudicated 11 complications in 9 subjects as being retrieval related (3.9%, 9 of 233 subjects). CONCLUSIONS: The safety and efficacy of chronic LP retrieval of an active helix-fixation device was demonstrated in an international clinical trial setting, with implant durations up to 9 years.
Abbott Medical Sylmar California USA
Amsterdam UMC University of Amsterdam Amsterdam the Netherlands
Heart and Vascular Institute Cleveland Clinic Cleveland Ohio USA
Hoag Memorial Hospital Newport Beach California USA
Icahn School of Medicine at Mount Sinai New York New York USA
Mayo Clinic Rochester Minnesota USA
Na Homolce Hospital Prague Czech Republic
References provided by Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc25009439
- 003
- CZ-PrNML
- 005
- 20250429134720.0
- 007
- ta
- 008
- 250415s2025 xxu f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1016/j.jacc.2024.10.094 $2 doi
- 035 __
- $a (PubMed)39772361
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a xxu
- 100 1_
- $a Neuzil, Petr $u Na Homolce Hospital, Prague, Czech Republic. Electronic address: pneuzil@seznam.cz
- 245 10
- $a Worldwide Chronic Retrieval Experience of Helix-Fixation Leadless Cardiac Pacemakers / $c P. Neuzil, DV. Exner, RE. Knops, DJ. Cantillon, P. Defaye, R. Banker, P. Friedman, C. Hubbard, SM. Delgado, A. Bulusu, VY. Reddy
- 520 9_
- $a BACKGROUND: The growing use of leadless pacemaker (LP) technology requires safe and effective solutions for retrieving and removing these devices over the long term. OBJECTIVES: This study sought to evaluate retrieval and removal of an active helix-fixation LP studied in worldwide regulatory clinical trials. METHODS: Subjects enrolled in the LEADLESS II phase 1 investigational device exemption, LEADLESS Observational, or LEADLESS Japan trials with an attempted LP retrieval at least 6 weeks postimplantation were included. The retrieval success rate was evaluated for all attempted retrievals. Site-reported complications associated with LP retrievals were quantified, with the severity and relationship adjudicated by an independent clinical events committee. RESULTS: There were 1,423 successful LP implants and 234 chronic LP retrieval attempts in 233 subjects. The overall retrieval success rate was 87.6% (205 of 234 attempts). The most common reason for failed retrieval (86.2%, 25 of 29 attempts) was inability to access the LP docking button. The mean time from implantation to attempted retrieval was 3.2 years (range 0.2-9.0 years) and did not significantly influence the retrieval success (P = 0.71). The clinical events committee adjudicated 11 complications in 9 subjects as being retrieval related (3.9%, 9 of 233 subjects). CONCLUSIONS: The safety and efficacy of chronic LP retrieval of an active helix-fixation device was demonstrated in an international clinical trial setting, with implant durations up to 9 years.
- 650 _2
- $a lidé $7 D006801
- 650 12
- $a kardiostimulátor $7 D010138
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a senioři $7 D000368
- 650 12
- $a odstranění implantátu $x metody $7 D020878
- 650 _2
- $a lidé středního věku $7 D008875
- 650 _2
- $a senioři nad 80 let $7 D000369
- 650 _2
- $a design vybavení $7 D004867
- 650 _2
- $a dospělí $7 D000328
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a multicentrická studie $7 D016448
- 700 1_
- $a Exner, Derek V $u University of Calgary, Calgary, Alberta, Canada
- 700 1_
- $a Knops, Reinoud E $u Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands
- 700 1_
- $a Cantillon, Daniel J $u Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio, USA
- 700 1_
- $a Defaye, Pascal $u University Hospital of Grenoble Alpes, Grenoble, France
- 700 1_
- $a Banker, Rajesh $u Hoag Memorial Hospital, Newport Beach, California, USA
- 700 1_
- $a Friedman, Paul $u Mayo Clinic, Rochester, Minnesota, USA
- 700 1_
- $a Hubbard, Chris $u Abbott Medical, Sylmar, California, USA
- 700 1_
- $a Delgado, Stephanie M $u Abbott Medical, Sylmar, California, USA
- 700 1_
- $a Bulusu, Anuradha $u Abbott Medical, Sylmar, California, USA
- 700 1_
- $a Reddy, Vivek Y $u Icahn School of Medicine at Mount Sinai, New York, New York, USA
- 773 0_
- $w MED00002964 $t Journal of the American College of Cardiology $x 1558-3597 $g Roč. 85, č. 11 (2025), s. 1111-1120
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/39772361 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y - $z 0
- 990 __
- $a 20250415 $b ABA008
- 991 __
- $a 20250429134716 $b ABA008
- 999 __
- $a ok $b bmc $g 2311055 $s 1246520
- BAS __
- $a 3
- BAS __
- $a PreBMC-MEDLINE
- BMC __
- $a 2025 $b 85 $c 11 $d 1111-1120 $e 20250108 $i 1558-3597 $m Journal of the American College of Cardiology $n J Am Coll Cardiol $x MED00002964
- LZP __
- $a Pubmed-20250415
