Impact of omitting the intravenous heparin bolus on outcomes of leadless pacemaker implantation
Background Early guidance recommended a bolus of intravenous heparin at the beginning of leadless pacemaker (LP) implantation procedures. However, due to concern about bleeding complications, more recent practice has tended toward omitting the bolus and only running a continuous heparin infusion thr...
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Published in | Journal of cardiovascular electrophysiology Vol. 35; no. 6; pp. 1212 - 1216 |
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Main Authors | , , , , , , , , , |
Format | Journal Article |
Language | English |
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United States
Wiley Subscription Services, Inc
01.06.2024
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ISSN | 1045-3873 1540-8167 1540-8167 |
DOI | 10.1111/jce.16284 |
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Abstract | Background
Early guidance recommended a bolus of intravenous heparin at the beginning of leadless pacemaker (LP) implantation procedures. However, due to concern about bleeding complications, more recent practice has tended toward omitting the bolus and only running a continuous heparin infusion through the introducer sheath. The impact of omitting the heparin bolus on procedural outcomes is not clear.
Methods
We reviewed all Medtronic Micra LP implants at our institution from 9/2014 to 9/2022. The decision to bolus with heparin was at operator discretion.
Results
Among 621 LP implants, 326 received an intravenous heparin bolus, 243 did not, and 52 patients were excluded because heparin bolus status could not be confirmed. There was a trend toward more frequent omission of the heparin bolus with more recent implants. Median follow‐up after LP implant was 14.3 (interquartile range [IQR]: 8.4–27.9) months. There was no difference between heparin bolus and no bolus groups in the number of device deployments/recaptures (1.42 ± 0.81 vs. 1.31 ± 0.66, p = .15). Implant‐related adverse events were also similar between heparin bolus and no bolus groups: access‐site hematoma requiring intervention (7 vs. 5, p = .99), pseudoaneurysm (1 vs. 1, p = .99), cardiac perforation (1 vs. 1, p = .99), intraprocedural device thrombus formation (2 vs. 4, p = .41), 30‐day rehospitalization (21 vs. 15, p = .98), and 30‐day all‐cause mortality (16 vs. 14, p = .70). There was one additional nonfatal cardiac perforation in a patient who was excluded due to unknown heparin bolus status. Regarding device electrical parameters between heparin bolus and no bolus groups, there were no significant differences at the time of implant: pacing capture threshold 0.5 ± 0.4 vs. 0.5 ± 0.3, p = .10; pacing impedance 739.9 ± 226.4 vs. 719.1 ± 215.4, p = .52; R wave sensing 11.7 ± 5.7 vs. 12.0 ± 5.4, p = .34). Long‐term device performance was also similar between groups.
Conclusion
Omission of the systemic heparin bolus at the time of LP implantation appears safe in appropriately selected patients. Heparin bolus may still be considered in long cases requiring multiple device deployments or in patients at high risk for thrombotic complications. |
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AbstractList | Background
Early guidance recommended a bolus of intravenous heparin at the beginning of leadless pacemaker (LP) implantation procedures. However, due to concern about bleeding complications, more recent practice has tended toward omitting the bolus and only running a continuous heparin infusion through the introducer sheath. The impact of omitting the heparin bolus on procedural outcomes is not clear.
Methods
We reviewed all Medtronic Micra LP implants at our institution from 9/2014 to 9/2022. The decision to bolus with heparin was at operator discretion.
Results
Among 621 LP implants, 326 received an intravenous heparin bolus, 243 did not, and 52 patients were excluded because heparin bolus status could not be confirmed. There was a trend toward more frequent omission of the heparin bolus with more recent implants. Median follow‐up after LP implant was 14.3 (interquartile range [IQR]: 8.4–27.9) months. There was no difference between heparin bolus and no bolus groups in the number of device deployments/recaptures (1.42 ± 0.81 vs. 1.31 ± 0.66, p = .15). Implant‐related adverse events were also similar between heparin bolus and no bolus groups: access‐site hematoma requiring intervention (7 vs. 5, p = .99), pseudoaneurysm (1 vs. 1, p = .99), cardiac perforation (1 vs. 1, p = .99), intraprocedural device thrombus formation (2 vs. 4, p = .41), 30‐day rehospitalization (21 vs. 15, p = .98), and 30‐day all‐cause mortality (16 vs. 14, p = .70). There was one additional nonfatal cardiac perforation in a patient who was excluded due to unknown heparin bolus status. Regarding device electrical parameters between heparin bolus and no bolus groups, there were no significant differences at the time of implant: pacing capture threshold 0.5 ± 0.4 vs. 0.5 ± 0.3, p = .10; pacing impedance 739.9 ± 226.4 vs. 719.1 ± 215.4, p = .52; R wave sensing 11.7 ± 5.7 vs. 12.0 ± 5.4, p = .34). Long‐term device performance was also similar between groups.
Conclusion
Omission of the systemic heparin bolus at the time of LP implantation appears safe in appropriately selected patients. Heparin bolus may still be considered in long cases requiring multiple device deployments or in patients at high risk for thrombotic complications. Early guidance recommended a bolus of intravenous heparin at the beginning of leadless pacemaker (LP) implantation procedures. However, due to concern about bleeding complications, more recent practice has tended toward omitting the bolus and only running a continuous heparin infusion through the introducer sheath. The impact of omitting the heparin bolus on procedural outcomes is not clear. We reviewed all Medtronic Micra LP implants at our institution from 9/2014 to 9/2022. The decision to bolus with heparin was at operator discretion. Among 621 LP implants, 326 received an intravenous heparin bolus, 243 did not, and 52 patients were excluded because heparin bolus status could not be confirmed. There was a trend toward more frequent omission of the heparin bolus with more recent implants. Median follow-up after LP implant was 14.3 (interquartile range [IQR]: 8.4-27.9) months. There was no difference between heparin bolus and no bolus groups in the number of device deployments/recaptures (1.42 ± 0.81 vs. 1.31 ± 0.66, p = .15). Implant-related adverse events were also similar between heparin bolus and no bolus groups: access-site hematoma requiring intervention (7 vs. 5, p = .99), pseudoaneurysm (1 vs. 1, p = .99), cardiac perforation (1 vs. 1, p = .99), intraprocedural device thrombus formation (2 vs. 4, p = .41), 30-day rehospitalization (21 vs. 15, p = .98), and 30-day all-cause mortality (16 vs. 14, p = .70). There was one additional nonfatal cardiac perforation in a patient who was excluded due to unknown heparin bolus status. Regarding device electrical parameters between heparin bolus and no bolus groups, there were no significant differences at the time of implant: pacing capture threshold 0.5 ± 0.4 vs. 0.5 ± 0.3, p = .10; pacing impedance 739.9 ± 226.4 vs. 719.1 ± 215.4, p = .52; R wave sensing 11.7 ± 5.7 vs. 12.0 ± 5.4, p = .34). Long-term device performance was also similar between groups. Omission of the systemic heparin bolus at the time of LP implantation appears safe in appropriately selected patients. Heparin bolus may still be considered in long cases requiring multiple device deployments or in patients at high risk for thrombotic complications. Early guidance recommended a bolus of intravenous heparin at the beginning of leadless pacemaker (LP) implantation procedures. However, due to concern about bleeding complications, more recent practice has tended toward omitting the bolus and only running a continuous heparin infusion through the introducer sheath. The impact of omitting the heparin bolus on procedural outcomes is not clear.BACKGROUNDEarly guidance recommended a bolus of intravenous heparin at the beginning of leadless pacemaker (LP) implantation procedures. However, due to concern about bleeding complications, more recent practice has tended toward omitting the bolus and only running a continuous heparin infusion through the introducer sheath. The impact of omitting the heparin bolus on procedural outcomes is not clear.We reviewed all Medtronic Micra LP implants at our institution from 9/2014 to 9/2022. The decision to bolus with heparin was at operator discretion.METHODSWe reviewed all Medtronic Micra LP implants at our institution from 9/2014 to 9/2022. The decision to bolus with heparin was at operator discretion.Among 621 LP implants, 326 received an intravenous heparin bolus, 243 did not, and 52 patients were excluded because heparin bolus status could not be confirmed. There was a trend toward more frequent omission of the heparin bolus with more recent implants. Median follow-up after LP implant was 14.3 (interquartile range [IQR]: 8.4-27.9) months. There was no difference between heparin bolus and no bolus groups in the number of device deployments/recaptures (1.42 ± 0.81 vs. 1.31 ± 0.66, p = .15). Implant-related adverse events were also similar between heparin bolus and no bolus groups: access-site hematoma requiring intervention (7 vs. 5, p = .99), pseudoaneurysm (1 vs. 1, p = .99), cardiac perforation (1 vs. 1, p = .99), intraprocedural device thrombus formation (2 vs. 4, p = .41), 30-day rehospitalization (21 vs. 15, p = .98), and 30-day all-cause mortality (16 vs. 14, p = .70). There was one additional nonfatal cardiac perforation in a patient who was excluded due to unknown heparin bolus status. Regarding device electrical parameters between heparin bolus and no bolus groups, there were no significant differences at the time of implant: pacing capture threshold 0.5 ± 0.4 vs. 0.5 ± 0.3, p = .10; pacing impedance 739.9 ± 226.4 vs. 719.1 ± 215.4, p = .52; R wave sensing 11.7 ± 5.7 vs. 12.0 ± 5.4, p = .34). Long-term device performance was also similar between groups.RESULTSAmong 621 LP implants, 326 received an intravenous heparin bolus, 243 did not, and 52 patients were excluded because heparin bolus status could not be confirmed. There was a trend toward more frequent omission of the heparin bolus with more recent implants. Median follow-up after LP implant was 14.3 (interquartile range [IQR]: 8.4-27.9) months. There was no difference between heparin bolus and no bolus groups in the number of device deployments/recaptures (1.42 ± 0.81 vs. 1.31 ± 0.66, p = .15). Implant-related adverse events were also similar between heparin bolus and no bolus groups: access-site hematoma requiring intervention (7 vs. 5, p = .99), pseudoaneurysm (1 vs. 1, p = .99), cardiac perforation (1 vs. 1, p = .99), intraprocedural device thrombus formation (2 vs. 4, p = .41), 30-day rehospitalization (21 vs. 15, p = .98), and 30-day all-cause mortality (16 vs. 14, p = .70). There was one additional nonfatal cardiac perforation in a patient who was excluded due to unknown heparin bolus status. Regarding device electrical parameters between heparin bolus and no bolus groups, there were no significant differences at the time of implant: pacing capture threshold 0.5 ± 0.4 vs. 0.5 ± 0.3, p = .10; pacing impedance 739.9 ± 226.4 vs. 719.1 ± 215.4, p = .52; R wave sensing 11.7 ± 5.7 vs. 12.0 ± 5.4, p = .34). Long-term device performance was also similar between groups.Omission of the systemic heparin bolus at the time of LP implantation appears safe in appropriately selected patients. Heparin bolus may still be considered in long cases requiring multiple device deployments or in patients at high risk for thrombotic complications.CONCLUSIONOmission of the systemic heparin bolus at the time of LP implantation appears safe in appropriately selected patients. Heparin bolus may still be considered in long cases requiring multiple device deployments or in patients at high risk for thrombotic complications. BackgroundEarly guidance recommended a bolus of intravenous heparin at the beginning of leadless pacemaker (LP) implantation procedures. However, due to concern about bleeding complications, more recent practice has tended toward omitting the bolus and only running a continuous heparin infusion through the introducer sheath. The impact of omitting the heparin bolus on procedural outcomes is not clear.MethodsWe reviewed all Medtronic Micra LP implants at our institution from 9/2014 to 9/2022. The decision to bolus with heparin was at operator discretion.ResultsAmong 621 LP implants, 326 received an intravenous heparin bolus, 243 did not, and 52 patients were excluded because heparin bolus status could not be confirmed. There was a trend toward more frequent omission of the heparin bolus with more recent implants. Median follow‐up after LP implant was 14.3 (interquartile range [IQR]: 8.4–27.9) months. There was no difference between heparin bolus and no bolus groups in the number of device deployments/recaptures (1.42 ± 0.81 vs. 1.31 ± 0.66, p = .15). Implant‐related adverse events were also similar between heparin bolus and no bolus groups: access‐site hematoma requiring intervention (7 vs. 5, p = .99), pseudoaneurysm (1 vs. 1, p = .99), cardiac perforation (1 vs. 1, p = .99), intraprocedural device thrombus formation (2 vs. 4, p = .41), 30‐day rehospitalization (21 vs. 15, p = .98), and 30‐day all‐cause mortality (16 vs. 14, p = .70). There was one additional nonfatal cardiac perforation in a patient who was excluded due to unknown heparin bolus status. Regarding device electrical parameters between heparin bolus and no bolus groups, there were no significant differences at the time of implant: pacing capture threshold 0.5 ± 0.4 vs. 0.5 ± 0.3, p = .10; pacing impedance 739.9 ± 226.4 vs. 719.1 ± 215.4, p = .52; R wave sensing 11.7 ± 5.7 vs. 12.0 ± 5.4, p = .34). Long‐term device performance was also similar between groups.ConclusionOmission of the systemic heparin bolus at the time of LP implantation appears safe in appropriately selected patients. Heparin bolus may still be considered in long cases requiring multiple device deployments or in patients at high risk for thrombotic complications. |
Author | El‐Chami, Mikhael F. Huang, Jingwen Shah, Anand Merchant, Faisal M. Lloyd, Michael S. Delurgio, David Patel, Anshul M. Bhatia, Neal K. Tompkins, Christine Westerman, Stacy |
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BackLink | https://www.ncbi.nlm.nih.gov/pubmed/38650520$$D View this record in MEDLINE/PubMed |
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Cites_doi | 10.1056/NEJMoa1511643 10.1093/europace/euab315 10.1056/NEJMoa1302946 10.1111/vcp.12390 10.1093/eurheartj/ehv214 10.1093/europace/euad269 10.1111/pace.12867 10.1111/jce.15863 10.1378/chest.126.4.1177 10.1016/j.hrthm.2023.09.017 10.1016/j.hrthm.2023.01.025 |
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Notes | Disclosures Neal K. Bhatia received honorarium Medtronic; Michael S. Lloyd received research funding and consulting Medtronic; Mikhael F. El‐Chami is a part of consulting and steering committee Medtronic. Other authors: No disclosures ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 |
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References_xml | – volume: 374 start-page: 533 issue: 6 year: 2016 end-page: 541 article-title: A leadless intracardiac transcatheter pacing system publication-title: N Engl J Med – volume: 25 start-page: 1 issue: 9 year: 2023 end-page: 9 article-title: Comparison of in‐hospital outcomes and complications of leadless pacemaker and traditional transvenous pacemaker implantation publication-title: Europace – volume: 39 start-page: 675 issue: 7 year: 2016 end-page: 679 article-title: Subcutaneous double “purse string suture”—a safe method for femoral vein access site closure after leadless pacemaker implantation publication-title: Pacing Clin Electrophysiol – volume: 368 start-page: 2084 issue: 22 year: 2013 end-page: 2093 article-title: Pacemaker or defibrillator surgery without interruption of anticoagulation publication-title: N Engl J Med – volume: 20 start-page: 754 issue: 5 year: 2023 end-page: 759 article-title: How to implant leadless pacemakers and mitigate major complications publication-title: Heart Rhythm – volume: 45 start-page: 648 issue: 4 year: 2016 end-page: 656 article-title: Sensitivity and specificity of normality tests and consequences on reference interval accuracy at small sample size: a computer‐simulation study publication-title: Vet Clin Pathol – volume: 126 start-page: 1177 issue: 4 year: 2004 end-page: 1186 article-title: Pocket hematoma after pacemaker or implantable cardioverter defibrillator surgery publication-title: Chest – volume: 21 start-page: 66 issue: 1 year: 2023 end-page: 73 article-title: Outcomes of patients implanted with an atrioventricular synchronous leadless ventricular pacemaker in the Medicare population publication-title: Heart Rhythm – volume: 34 start-page: 1015 issue: 4 year: 2023 end-page: 1023 article-title: Leadless versus transvenous single‐chamber ventricular pacemakers: 3 year follow‐up of the micra CED study publication-title: J Cardiovasc Electrophysiol – volume: 24 start-page: 1119 issue: 7 year: 2022 end-page: 1126 article-title: Development and validation of a risk score for predicting pericardial effusion in patients undergoing leadless pacemaker implantation: experience with the micra transcatheter pacemaker publication-title: EP Europace – volume: 36 start-page: 2510 issue: 37 year: 2015 end-page: 2519 article-title: Early performance of a miniaturized leadless cardiac pacemaker: the micra transcatheter pacing study publication-title: Eur Heart J – ident: e_1_2_8_2_1 doi: 10.1056/NEJMoa1511643 – ident: e_1_2_8_13_1 doi: 10.1093/europace/euab315 – ident: e_1_2_8_6_1 doi: 10.1056/NEJMoa1302946 – ident: e_1_2_8_7_1 doi: 10.1111/vcp.12390 – ident: e_1_2_8_8_1 doi: 10.1093/eurheartj/ehv214 – ident: e_1_2_8_10_1 doi: 10.1093/europace/euad269 – ident: e_1_2_8_9_1 doi: 10.1111/pace.12867 – ident: e_1_2_8_3_1 doi: 10.1111/jce.15863 – ident: e_1_2_8_5_1 doi: 10.1378/chest.126.4.1177 – ident: e_1_2_8_11_1 doi: 10.1016/j.hrthm.2023.09.017 – ident: e_1_2_8_12_1 doi: 10.1016/j.hrthm.2023.01.025 – ident: e_1_2_8_4_1 |
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Early guidance recommended a bolus of intravenous heparin at the beginning of leadless pacemaker (LP) implantation procedures. However, due to... Early guidance recommended a bolus of intravenous heparin at the beginning of leadless pacemaker (LP) implantation procedures. However, due to concern about... BackgroundEarly guidance recommended a bolus of intravenous heparin at the beginning of leadless pacemaker (LP) implantation procedures. However, due to... |
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SubjectTerms | Aged Aged, 80 and over Anticoagulants Anticoagulants - administration & dosage Anticoagulants - adverse effects Cardiac Pacing, Artificial clinical:implantable devices–pacemaker‐bradyarrhythmias Drug Administration Schedule Female Heart Hematoma Heparin Heparin - administration & dosage Heparin - adverse effects Humans Intravenous administration Male Middle Aged Pacemaker, Artificial Pacemakers Prosthesis Design Prosthesis Implantation - adverse effects Prosthesis Implantation - instrumentation Pseudoaneurysm Retrospective Studies Risk Factors Thrombosis Time Factors Transplants & implants Treatment Outcome |
Title | Impact of omitting the intravenous heparin bolus on outcomes of leadless pacemaker implantation |
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