Outcomes of Micra leadless pacemaker implantation with uninterrupted anticoagulation
Background Implantation of the MICRA Leadless pacemaker requires the use of a 27 French introducer, blunt delivery system and device fixation to the myocardium via nitinol tines. While prior studies have proven its safety, it is unclear whether performing this procedure with uninterrupted anticoagul...
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| Veröffentlicht in: | Journal of cardiovascular electrophysiology 2019-08, Vol.30 (8), p.1313-1318 |
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| creator | Kiani, Soroosh Black, George B. Rao, Birju Thakkar, Nancy Massad, Christopher Patel, Akshar V. Merchant, Faisal M. Hoskins, Michael H. Lurgio, David B. Patel, Anshul M. Shah, Anand D. Leon, Angel R. Westerman, Stacy B. Lloyd, Michael S. El‐Chami, Mikhael F. |
| description | Background
Implantation of the MICRA Leadless pacemaker requires the use of a 27 French introducer, blunt delivery system and device fixation to the myocardium via nitinol tines. While prior studies have proven its safety, it is unclear whether performing this procedure with uninterrupted anticoagulation exposes patients to increased risks. We sought to investigate the feasibility and safety of continuing therapeutic anticoagulation during the periprocedural period.
Methods
We evaluated all patients undergoing MICRA placement at our institution between April 2014 and August 2018 with complete follow‐up data (n = 170). Patients were stratified into two groups: those on active anticoagulation (OAC, n = 26), defined as having an International normalized ratio >2.0 or having continued a direct oral anticoagulant, and those not anticoagulated (Off‐OAC, n = 144). We evaluated for a composite outcome of all major complications, including access site complications and pericardial effusion.
Results
OAC and Off‐OAC groups had similar mean age (74 ± 13 vs 75 ± 13 years; P = .914). The OAC group had a nonsignificantly lower prevalence of end‐stage renal disease (8% vs 17%; P = .375) and aspirin use (27% vs 47%; P = .131). Those in the OAC group were more likely to be on warfarin than those in the Off‐OAC group (81% vs 30%; P |
| doi_str_mv | 10.1111/jce.13965 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2219000673</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2269960772</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3535-7dfc4affb29057b1070df85a07eb9ed9c9f4a2bcdb0219f004038cc83789cbbf3</originalsourceid><addsrcrecordid>eNp10MtKxDAUBuAgiveFLyABN7qoc9K0TbOUYbwxMhtdlzQ90Yy9mbQM8_ZmHHUhmE0C58vP4SfkjME1C2ey1HjNuMzSHXLI0gSinGViN7whSSOeC35AjrxfAjCeQbpPDvhmEsvskDwvxkF3DXraGfpktVO0RlXV6D3tlcZGvaOjtulr1Q5qsF1LV3Z4o2Nr2wGdG_sBKxpmVnfqday_yAnZM6r2ePp9H5OX29nz9D6aL-4epjfzSPOUp5GojE6UMWUsIRUlAwGVyVMFAkuJldTSJCoudVVCzKQBSIDnWudc5FKXpeHH5HKb27vuY0Q_FI31GuuwK3ajL-LwDQAywQO9-EOX3ejasF1QmZQZCBEHdbVV2nXeOzRF72yj3LpgUGyqLkLVxVfVwZ5_J45lg9Wv_Ok2gMkWrGyN6_-TisfpbBv5CVPviQU</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2269960772</pqid></control><display><type>article</type><title>Outcomes of Micra leadless pacemaker implantation with uninterrupted anticoagulation</title><source>Wiley Online Library Journals Frontfile Complete</source><creator>Kiani, Soroosh ; Black, George B. ; Rao, Birju ; Thakkar, Nancy ; Massad, Christopher ; Patel, Akshar V. ; Merchant, Faisal M. ; Hoskins, Michael H. ; Lurgio, David B. ; Patel, Anshul M. ; Shah, Anand D. ; Leon, Angel R. ; Westerman, Stacy B. ; Lloyd, Michael S. ; El‐Chami, Mikhael F.</creator><creatorcontrib>Kiani, Soroosh ; Black, George B. ; Rao, Birju ; Thakkar, Nancy ; Massad, Christopher ; Patel, Akshar V. ; Merchant, Faisal M. ; Hoskins, Michael H. ; Lurgio, David B. ; Patel, Anshul M. ; Shah, Anand D. ; Leon, Angel R. ; Westerman, Stacy B. ; Lloyd, Michael S. ; El‐Chami, Mikhael F.</creatorcontrib><description>Background
Implantation of the MICRA Leadless pacemaker requires the use of a 27 French introducer, blunt delivery system and device fixation to the myocardium via nitinol tines. While prior studies have proven its safety, it is unclear whether performing this procedure with uninterrupted anticoagulation exposes patients to increased risks. We sought to investigate the feasibility and safety of continuing therapeutic anticoagulation during the periprocedural period.
Methods
We evaluated all patients undergoing MICRA placement at our institution between April 2014 and August 2018 with complete follow‐up data (n = 170). Patients were stratified into two groups: those on active anticoagulation (OAC, n = 26), defined as having an International normalized ratio >2.0 or having continued a direct oral anticoagulant, and those not anticoagulated (Off‐OAC, n = 144). We evaluated for a composite outcome of all major complications, including access site complications and pericardial effusion.
Results
OAC and Off‐OAC groups had similar mean age (74 ± 13 vs 75 ± 13 years; P = .914). The OAC group had a nonsignificantly lower prevalence of end‐stage renal disease (8% vs 17%; P = .375) and aspirin use (27% vs 47%; P = .131). Those in the OAC group were more likely to be on warfarin than those in the Off‐OAC group (81% vs 30%; P < .001). The rate of the composite endpoint was similar between the OAC and Off‐OAC groups (3.8 % vs 1.4%, respectively; P = .761). Length of stay was similar between groups (1.3 ± 2.6 vs 2.3 ± 3.4 days; P = 0.108).
Conclusion
Continuation of therapeutic anticoagulation during MICRA implantation appears to be feasible, safe and associated with shorter hospitalization among appropriately selected individuals.</description><identifier>ISSN: 1045-3873</identifier><identifier>EISSN: 1540-8167</identifier><identifier>DOI: 10.1111/jce.13965</identifier><identifier>PMID: 31045296</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>Anticoagulants ; Aspirin ; Clinical: Implantable devices – pacemaker‐bradyarrhythmias ; Complications ; Effusion ; Feasibility ; Feasibility studies ; Implantation ; Myocardium ; Nickel titanides ; Warfarin</subject><ispartof>Journal of cardiovascular electrophysiology, 2019-08, Vol.30 (8), p.1313-1318</ispartof><rights>2019 Wiley Periodicals, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3535-7dfc4affb29057b1070df85a07eb9ed9c9f4a2bcdb0219f004038cc83789cbbf3</citedby><cites>FETCH-LOGICAL-c3535-7dfc4affb29057b1070df85a07eb9ed9c9f4a2bcdb0219f004038cc83789cbbf3</cites><orcidid>0000-0001-6389-0643 ; 0000-0002-0708-9330 ; 0000-0003-4978-7177</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fjce.13965$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fjce.13965$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31045296$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kiani, Soroosh</creatorcontrib><creatorcontrib>Black, George B.</creatorcontrib><creatorcontrib>Rao, Birju</creatorcontrib><creatorcontrib>Thakkar, Nancy</creatorcontrib><creatorcontrib>Massad, Christopher</creatorcontrib><creatorcontrib>Patel, Akshar V.</creatorcontrib><creatorcontrib>Merchant, Faisal M.</creatorcontrib><creatorcontrib>Hoskins, Michael H.</creatorcontrib><creatorcontrib>Lurgio, David B.</creatorcontrib><creatorcontrib>Patel, Anshul M.</creatorcontrib><creatorcontrib>Shah, Anand D.</creatorcontrib><creatorcontrib>Leon, Angel R.</creatorcontrib><creatorcontrib>Westerman, Stacy B.</creatorcontrib><creatorcontrib>Lloyd, Michael S.</creatorcontrib><creatorcontrib>El‐Chami, Mikhael F.</creatorcontrib><title>Outcomes of Micra leadless pacemaker implantation with uninterrupted anticoagulation</title><title>Journal of cardiovascular electrophysiology</title><addtitle>J Cardiovasc Electrophysiol</addtitle><description>Background
Implantation of the MICRA Leadless pacemaker requires the use of a 27 French introducer, blunt delivery system and device fixation to the myocardium via nitinol tines. While prior studies have proven its safety, it is unclear whether performing this procedure with uninterrupted anticoagulation exposes patients to increased risks. We sought to investigate the feasibility and safety of continuing therapeutic anticoagulation during the periprocedural period.
Methods
We evaluated all patients undergoing MICRA placement at our institution between April 2014 and August 2018 with complete follow‐up data (n = 170). Patients were stratified into two groups: those on active anticoagulation (OAC, n = 26), defined as having an International normalized ratio >2.0 or having continued a direct oral anticoagulant, and those not anticoagulated (Off‐OAC, n = 144). We evaluated for a composite outcome of all major complications, including access site complications and pericardial effusion.
Results
OAC and Off‐OAC groups had similar mean age (74 ± 13 vs 75 ± 13 years; P = .914). The OAC group had a nonsignificantly lower prevalence of end‐stage renal disease (8% vs 17%; P = .375) and aspirin use (27% vs 47%; P = .131). Those in the OAC group were more likely to be on warfarin than those in the Off‐OAC group (81% vs 30%; P < .001). The rate of the composite endpoint was similar between the OAC and Off‐OAC groups (3.8 % vs 1.4%, respectively; P = .761). Length of stay was similar between groups (1.3 ± 2.6 vs 2.3 ± 3.4 days; P = 0.108).
Conclusion
Continuation of therapeutic anticoagulation during MICRA implantation appears to be feasible, safe and associated with shorter hospitalization among appropriately selected individuals.</description><subject>Anticoagulants</subject><subject>Aspirin</subject><subject>Clinical: Implantable devices – pacemaker‐bradyarrhythmias</subject><subject>Complications</subject><subject>Effusion</subject><subject>Feasibility</subject><subject>Feasibility studies</subject><subject>Implantation</subject><subject>Myocardium</subject><subject>Nickel titanides</subject><subject>Warfarin</subject><issn>1045-3873</issn><issn>1540-8167</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><recordid>eNp10MtKxDAUBuAgiveFLyABN7qoc9K0TbOUYbwxMhtdlzQ90Yy9mbQM8_ZmHHUhmE0C58vP4SfkjME1C2ey1HjNuMzSHXLI0gSinGViN7whSSOeC35AjrxfAjCeQbpPDvhmEsvskDwvxkF3DXraGfpktVO0RlXV6D3tlcZGvaOjtulr1Q5qsF1LV3Z4o2Nr2wGdG_sBKxpmVnfqday_yAnZM6r2ePp9H5OX29nz9D6aL-4epjfzSPOUp5GojE6UMWUsIRUlAwGVyVMFAkuJldTSJCoudVVCzKQBSIDnWudc5FKXpeHH5HKb27vuY0Q_FI31GuuwK3ajL-LwDQAywQO9-EOX3ejasF1QmZQZCBEHdbVV2nXeOzRF72yj3LpgUGyqLkLVxVfVwZ5_J45lg9Wv_Ok2gMkWrGyN6_-TisfpbBv5CVPviQU</recordid><startdate>201908</startdate><enddate>201908</enddate><creator>Kiani, Soroosh</creator><creator>Black, George B.</creator><creator>Rao, Birju</creator><creator>Thakkar, Nancy</creator><creator>Massad, Christopher</creator><creator>Patel, Akshar V.</creator><creator>Merchant, Faisal M.</creator><creator>Hoskins, Michael H.</creator><creator>Lurgio, David B.</creator><creator>Patel, Anshul M.</creator><creator>Shah, Anand D.</creator><creator>Leon, Angel R.</creator><creator>Westerman, Stacy B.</creator><creator>Lloyd, Michael S.</creator><creator>El‐Chami, Mikhael F.</creator><general>Wiley Subscription Services, Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QP</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-6389-0643</orcidid><orcidid>https://orcid.org/0000-0002-0708-9330</orcidid><orcidid>https://orcid.org/0000-0003-4978-7177</orcidid></search><sort><creationdate>201908</creationdate><title>Outcomes of Micra leadless pacemaker implantation with uninterrupted anticoagulation</title><author>Kiani, Soroosh ; Black, George B. ; Rao, Birju ; Thakkar, Nancy ; Massad, Christopher ; Patel, Akshar V. ; Merchant, Faisal M. ; Hoskins, Michael H. ; Lurgio, David B. ; Patel, Anshul M. ; Shah, Anand D. ; Leon, Angel R. ; Westerman, Stacy B. ; Lloyd, Michael S. ; El‐Chami, Mikhael F.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3535-7dfc4affb29057b1070df85a07eb9ed9c9f4a2bcdb0219f004038cc83789cbbf3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Anticoagulants</topic><topic>Aspirin</topic><topic>Clinical: Implantable devices – pacemaker‐bradyarrhythmias</topic><topic>Complications</topic><topic>Effusion</topic><topic>Feasibility</topic><topic>Feasibility studies</topic><topic>Implantation</topic><topic>Myocardium</topic><topic>Nickel titanides</topic><topic>Warfarin</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kiani, Soroosh</creatorcontrib><creatorcontrib>Black, George B.</creatorcontrib><creatorcontrib>Rao, Birju</creatorcontrib><creatorcontrib>Thakkar, Nancy</creatorcontrib><creatorcontrib>Massad, Christopher</creatorcontrib><creatorcontrib>Patel, Akshar V.</creatorcontrib><creatorcontrib>Merchant, Faisal M.</creatorcontrib><creatorcontrib>Hoskins, Michael H.</creatorcontrib><creatorcontrib>Lurgio, David B.</creatorcontrib><creatorcontrib>Patel, Anshul M.</creatorcontrib><creatorcontrib>Shah, Anand D.</creatorcontrib><creatorcontrib>Leon, Angel R.</creatorcontrib><creatorcontrib>Westerman, Stacy B.</creatorcontrib><creatorcontrib>Lloyd, Michael S.</creatorcontrib><creatorcontrib>El‐Chami, Mikhael F.</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of cardiovascular electrophysiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kiani, Soroosh</au><au>Black, George B.</au><au>Rao, Birju</au><au>Thakkar, Nancy</au><au>Massad, Christopher</au><au>Patel, Akshar V.</au><au>Merchant, Faisal M.</au><au>Hoskins, Michael H.</au><au>Lurgio, David B.</au><au>Patel, Anshul M.</au><au>Shah, Anand D.</au><au>Leon, Angel R.</au><au>Westerman, Stacy B.</au><au>Lloyd, Michael S.</au><au>El‐Chami, Mikhael F.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Outcomes of Micra leadless pacemaker implantation with uninterrupted anticoagulation</atitle><jtitle>Journal of cardiovascular electrophysiology</jtitle><addtitle>J Cardiovasc Electrophysiol</addtitle><date>2019-08</date><risdate>2019</risdate><volume>30</volume><issue>8</issue><spage>1313</spage><epage>1318</epage><pages>1313-1318</pages><issn>1045-3873</issn><eissn>1540-8167</eissn><abstract>Background
Implantation of the MICRA Leadless pacemaker requires the use of a 27 French introducer, blunt delivery system and device fixation to the myocardium via nitinol tines. While prior studies have proven its safety, it is unclear whether performing this procedure with uninterrupted anticoagulation exposes patients to increased risks. We sought to investigate the feasibility and safety of continuing therapeutic anticoagulation during the periprocedural period.
Methods
We evaluated all patients undergoing MICRA placement at our institution between April 2014 and August 2018 with complete follow‐up data (n = 170). Patients were stratified into two groups: those on active anticoagulation (OAC, n = 26), defined as having an International normalized ratio >2.0 or having continued a direct oral anticoagulant, and those not anticoagulated (Off‐OAC, n = 144). We evaluated for a composite outcome of all major complications, including access site complications and pericardial effusion.
Results
OAC and Off‐OAC groups had similar mean age (74 ± 13 vs 75 ± 13 years; P = .914). The OAC group had a nonsignificantly lower prevalence of end‐stage renal disease (8% vs 17%; P = .375) and aspirin use (27% vs 47%; P = .131). Those in the OAC group were more likely to be on warfarin than those in the Off‐OAC group (81% vs 30%; P < .001). The rate of the composite endpoint was similar between the OAC and Off‐OAC groups (3.8 % vs 1.4%, respectively; P = .761). Length of stay was similar between groups (1.3 ± 2.6 vs 2.3 ± 3.4 days; P = 0.108).
Conclusion
Continuation of therapeutic anticoagulation during MICRA implantation appears to be feasible, safe and associated with shorter hospitalization among appropriately selected individuals.</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>31045296</pmid><doi>10.1111/jce.13965</doi><tpages>6</tpages><orcidid>https://orcid.org/0000-0001-6389-0643</orcidid><orcidid>https://orcid.org/0000-0002-0708-9330</orcidid><orcidid>https://orcid.org/0000-0003-4978-7177</orcidid></addata></record> |
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| source | Wiley Online Library Journals Frontfile Complete |
| subjects | Anticoagulants Aspirin Clinical: Implantable devices – pacemaker‐bradyarrhythmias Complications Effusion Feasibility Feasibility studies Implantation Myocardium Nickel titanides Warfarin |
| title | Outcomes of Micra leadless pacemaker implantation with uninterrupted anticoagulation |
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