Worldwide Chronic Retrieval Experience of Helix-Fixation Leadless Cardiac Pacemakers
The growing use of leadless pacemaker (LP) technology requires safe and effective solutions for retrieving and removing these devices over the long term. This study sought to evaluate retrieval and removal of an active helix-fixation LP studied in worldwide regulatory clinical trials. Subjects enrol...
Saved in:
| Published in: | Journal of the American College of Cardiology Vol. 85; no. 11; p. 1111 |
|---|---|
| Main Authors: | , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
United States
25.03.2025
|
| Subjects: | |
| ISSN: | 1558-3597, 1558-3597 |
| Online Access: | Get more information |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| Abstract | The growing use of leadless pacemaker (LP) technology requires safe and effective solutions for retrieving and removing these devices over the long term.
This study sought to evaluate retrieval and removal of an active helix-fixation LP studied in worldwide regulatory clinical trials.
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.
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).
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. |
|---|---|
| AbstractList | The growing use of leadless pacemaker (LP) technology requires safe and effective solutions for retrieving and removing these devices over the long term.
This study sought to evaluate retrieval and removal of an active helix-fixation LP studied in worldwide regulatory clinical trials.
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.
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).
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. The growing use of leadless pacemaker (LP) technology requires safe and effective solutions for retrieving and removing these devices over the long term.BACKGROUNDThe growing use of leadless pacemaker (LP) technology requires safe and effective solutions for retrieving and removing these devices over the long term.This study sought to evaluate retrieval and removal of an active helix-fixation LP studied in worldwide regulatory clinical trials.OBJECTIVESThis study sought to evaluate retrieval and removal of an active helix-fixation LP studied in worldwide regulatory clinical trials.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.METHODSSubjects 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.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).RESULTSThere 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).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.CONCLUSIONSThe 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. |
| Author | Reddy, Vivek Y Bulusu, Anuradha Neuzil, Petr Defaye, Pascal Exner, Derek V Delgado, Stephanie M Knops, Reinoud E Friedman, Paul Hubbard, Chris Cantillon, Daniel J Banker, Rajesh |
| Author_xml | – sequence: 1 givenname: Petr surname: Neuzil fullname: Neuzil, Petr email: pneuzil@seznam.cz organization: Na Homolce Hospital, Prague, Czech Republic. Electronic address: pneuzil@seznam.cz – sequence: 2 givenname: Derek V surname: Exner fullname: Exner, Derek V organization: University of Calgary, Calgary, Alberta, Canada – sequence: 3 givenname: Reinoud E surname: Knops fullname: Knops, Reinoud E organization: Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands – sequence: 4 givenname: Daniel J surname: Cantillon fullname: Cantillon, Daniel J organization: Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio, USA – sequence: 5 givenname: Pascal surname: Defaye fullname: Defaye, Pascal organization: University Hospital of Grenoble Alpes, Grenoble, France – sequence: 6 givenname: Rajesh surname: Banker fullname: Banker, Rajesh organization: Hoag Memorial Hospital, Newport Beach, California, USA – sequence: 7 givenname: Paul surname: Friedman fullname: Friedman, Paul organization: Mayo Clinic, Rochester, Minnesota, USA – sequence: 8 givenname: Chris surname: Hubbard fullname: Hubbard, Chris organization: Abbott Medical, Sylmar, California, USA – sequence: 9 givenname: Stephanie M surname: Delgado fullname: Delgado, Stephanie M organization: Abbott Medical, Sylmar, California, USA – sequence: 10 givenname: Anuradha surname: Bulusu fullname: Bulusu, Anuradha organization: Abbott Medical, Sylmar, California, USA – sequence: 11 givenname: Vivek Y surname: Reddy fullname: Reddy, Vivek Y organization: Icahn School of Medicine at Mount Sinai, New York, New York, USA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/39772361$$D View this record in MEDLINE/PubMed |
| BookMark | eNpNUM1Kw0AYXKRiW_UFPEiOXhL3N9s9SmmtUFDEn2PYfPsFt-anZlOtb9Nn6ZMZsIKXmWEYBmbGZFA3NRJywWjCKEuvV8nKAiScctkbCTXyiIyYUpNYKKMH__SQjENYUUrTCTMnZCiM1lykbEReXpu2dF_eYTR9a5vaQ_SIXevx05bRbLvGXtaA-11TRAss_Tae-63tfFNHS7SuxBD2u6ltnbcQPVjAyr5jG87IcWHLgOcHPiXP89nTdBEv72_vpjfLGJTgXQwmBaRSKS7QOY7aKGELWehcO8Mnkmvu-nU9FAIgpxJcLg2VBThUAJafkqvf3nXbfGwwdFnlA2BZ2hqbTcgE04ZLyVLVRy8P0U1eocvWra9s-539fcF_ACXYZjQ |
| CitedBy_id | crossref_primary_10_1016_j_jacc_2024_11_027 crossref_primary_10_1016_j_jacep_2025_04_031 crossref_primary_10_1016_j_hrthm_2025_06_030 crossref_primary_10_1007_s00059_025_05337_7 crossref_primary_10_1016_j_jacc_2025_02_013 crossref_primary_10_1016_j_hrthm_2025_05_002 |
| ContentType | Journal Article |
| Copyright | Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved. |
| Copyright_xml | – notice: Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved. |
| DBID | CGR CUY CVF ECM EIF NPM 7X8 |
| DOI | 10.1016/j.jacc.2024.10.094 |
| DatabaseName | Medline MEDLINE MEDLINE (Ovid) MEDLINE MEDLINE PubMed MEDLINE - Academic |
| DatabaseTitle | MEDLINE Medline Complete MEDLINE with Full Text PubMed MEDLINE (Ovid) MEDLINE - Academic |
| DatabaseTitleList | MEDLINE MEDLINE - Academic |
| Database_xml | – sequence: 1 dbid: NPM name: PubMed url: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed sourceTypes: Index Database – sequence: 2 dbid: 7X8 name: MEDLINE - Academic url: https://search.proquest.com/medline sourceTypes: Aggregation Database |
| DeliveryMethod | no_fulltext_linktorsrc |
| Discipline | Medicine |
| EISSN | 1558-3597 |
| ExternalDocumentID | 39772361 |
| Genre | Evaluation Study Journal Article |
| GroupedDBID | --- --K --M .1- .FO .~1 0R~ 18M 1B1 1P~ 1~. 1~5 4.4 457 4G. 5GY 5RE 5VS 6PF 7-5 71M 8P~ AABNK AABVL AAEDT AAEDW AAIKJ AAKUH AALRI AAOAW AAQFI AAQQT AAXUO ABBQC ABFNM ABFRF ABLJU ABMAC ABMZM ABOCM ACGFO ACGFS ACIUM ACJTP ACPRK ACVFH ADBBV ADCNI ADEZE AEFWE AEKER AENEX AEVXI AFCTW AFETI AFRAH AFRHN AFTJW AGCQF AGYEJ AHMBA AITUG AJRQY AKRWK ALMA_UNASSIGNED_HOLDINGS AMRAJ BAWUL BLXMC CGR CS3 CUY CVF DU5 E3Z EBS ECM EFKBS EIF EO8 EO9 EP2 EP3 F5P FDB FEDTE FNPLU G-Q GBLVA GX1 HVGLF IHE IXB J1W KQ8 L7B MO0 N9A NPM O-L O9- OA. OAUVE OK1 OL~ OZT P-8 P-9 P2P PC. PQQKQ Q38 ROL RPZ SCC SDF SDG SDP SES SEW SSZ TR2 UNMZH UV1 WH7 WOQ WOW YYM YZZ Z5R 7X8 ~HD |
| ID | FETCH-LOGICAL-c532t-c96ce045523edd2e7953af4f7b7d9284272d0242d0f3ccb04cdb4904fcde5cca2 |
| IEDL.DBID | 7X8 |
| ISICitedReferencesCount | 7 |
| ISICitedReferencesURI | http://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=Summon&SrcAuth=ProQuest&DestLinkType=CitingArticles&DestApp=WOS_CPL&KeyUT=001486907500001&url=https%3A%2F%2Fcvtisr.summon.serialssolutions.com%2F%23%21%2Fsearch%3Fho%3Df%26include.ft.matches%3Dt%26l%3Dnull%26q%3D |
| ISSN | 1558-3597 |
| IngestDate | Thu Oct 02 10:58:36 EDT 2025 Mon Jul 21 06:01:35 EDT 2025 |
| IsDoiOpenAccess | false |
| IsOpenAccess | true |
| IsPeerReviewed | true |
| IsScholarly | true |
| Issue | 11 |
| Keywords | leadless pacemaker retrieval leadless pacemaker replacement helix-fixation |
| Language | English |
| License | Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved. |
| LinkModel | DirectLink |
| MergedId | FETCHMERGED-LOGICAL-c532t-c96ce045523edd2e7953af4f7b7d9284272d0242d0f3ccb04cdb4904fcde5cca2 |
| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 |
| OpenAccessLink | https://dx.doi.org/10.1016/j.jacc.2024.10.094 |
| PMID | 39772361 |
| PQID | 3179244165 |
| PQPubID | 23479 |
| ParticipantIDs | proquest_miscellaneous_3179244165 pubmed_primary_39772361 |
| PublicationCentury | 2000 |
| PublicationDate | 2025-03-25 |
| PublicationDateYYYYMMDD | 2025-03-25 |
| PublicationDate_xml | – month: 03 year: 2025 text: 2025-03-25 day: 25 |
| PublicationDecade | 2020 |
| PublicationPlace | United States |
| PublicationPlace_xml | – name: United States |
| PublicationTitle | Journal of the American College of Cardiology |
| PublicationTitleAlternate | J Am Coll Cardiol |
| PublicationYear | 2025 |
| SSID | ssj0006819 |
| Score | 2.5124295 |
| Snippet | The growing use of leadless pacemaker (LP) technology requires safe and effective solutions for retrieving and removing these devices over the long term.
This... The growing use of leadless pacemaker (LP) technology requires safe and effective solutions for retrieving and removing these devices over the long... |
| SourceID | proquest pubmed |
| SourceType | Aggregation Database Index Database |
| StartPage | 1111 |
| SubjectTerms | Adult Aged Aged, 80 and over Clinical Trials, Phase I as Topic Device Removal - adverse effects Device Removal - methods Equipment Design Female Humans Male Middle Aged Multicenter Studies as Topic Observational Studies as Topic Pacemaker, Artificial - adverse effects |
| Title | Worldwide Chronic Retrieval Experience of Helix-Fixation Leadless Cardiac Pacemakers |
| URI | https://www.ncbi.nlm.nih.gov/pubmed/39772361 https://www.proquest.com/docview/3179244165 |
| Volume | 85 |
| WOSCitedRecordID | wos001486907500001&url=https%3A%2F%2Fcvtisr.summon.serialssolutions.com%2F%23%21%2Fsearch%3Fho%3Df%26include.ft.matches%3Dt%26l%3Dnull%26q%3D |
| hasFullText | |
| inHoldings | 1 |
| isFullTextHit | |
| isPrint | |
| link | http://cvtisr.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwpV1LS8NAEF7Uinjx_agvVvC6mu5usslJpFi8tBSp0FvY7APiI6m2an--s5stPQmCl5BLQpidzPfN7Ox8CF2lvIgSDZmqKzAQDphM0kJauLOAdprJgisvNiEGg3Q8zoah4DYNbZWLmOgDta6Vq5HfAM5BqgD0Ib6dvBOnGuV2V4OExipqMaAyrqVLjJfTwpPUC3sAZKaEAXMOh2aa_q5nqdwIQ8qvXXeXEy3-jWJ6qOlt__cjd9BWIJn4rvGKXbRiqj200Q_b6Pto5FtovkttcBiOix-9sha4HV4OP8a1xQBL5Zz0yrlfQewUOV8hOOKu9yyFh1KZN_kCJPIAPfXuR90HEuQViIoZnRGVJcoAo4NU1GhNjchiJi23ohA6A9SigmqH4DqyTKki4koXPIu4VdrEsPD0EK1VdWWOEU6tABqpIy4YpFdAOuMikR3Z4bIQ8P64jS4X9srBfd2ehKxM_TnNlxZro6PG6PmkmbORO27qZsOc_OHpU7RJnTJvxAiNz1DLws9rztG6-pqV048L7xdwHQz7P5gawZs |
| linkProvider | ProQuest |
| openUrl | ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fsummon.serialssolutions.com&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Worldwide+Chronic+Retrieval+Experience%C2%A0of+Helix-Fixation+Leadless%C2%A0Cardiac+Pacemakers&rft.jtitle=Journal+of+the+American+College+of+Cardiology&rft.au=Neuzil%2C+Petr&rft.au=Exner%2C+Derek+V&rft.au=Knops%2C+Reinoud+E&rft.au=Cantillon%2C+Daniel+J&rft.date=2025-03-25&rft.eissn=1558-3597&rft.volume=85&rft.issue=11&rft.spage=1111&rft_id=info:doi/10.1016%2Fj.jacc.2024.10.094&rft_id=info%3Apmid%2F39772361&rft_id=info%3Apmid%2F39772361&rft.externalDocID=39772361 |
| thumbnail_l | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/lc.gif&issn=1558-3597&client=summon |
| thumbnail_m | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/mc.gif&issn=1558-3597&client=summon |
| thumbnail_s | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/sc.gif&issn=1558-3597&client=summon |