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      Leadless pacemaker implantation after transcatheter lead extraction in complex anatomy patient

      case-report

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          Key Clinical Message

          After transvenous lead extraction, leadless pacemaker might be a valid alternative to the traditional two‐step strategy including an active fixation leads temporary PM and subsequent contralateral permanent implantation in patients who are pacemaker‐dependent. Moreover, leadless PM might be of great importance in patients presenting with congenital vascular or cardiac abnormality.

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          Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management: this document was endorsed by the American Heart Association (AHA).

          Bruce L Wilkoff, Charles J. Love, Charles Byrd … (2009)
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            Incidence and predictors of short- and long-term complications in pacemaker therapy: the FOLLOWPACE study.

            Erik Udo, Nicolaas Zuithoff, Norbert van Hemel … (2012)
            Today quantitative information about the type of complications and their incidence during long-term pacemaker (PM) follow-up is scarce. To assess the incidence and determinants of short- and long-term complications after first pacemaker implantation for bradycardia. A prospective multicenter cohort study (the FOLLOWPACE study) was conducted among 1517 patients receiving a PM between January 2003 and November 2007. The independent association of patient and implantation-procedure characteristics with the incidence of PM complications was analyzed using multivariable Cox regression analysis. A total of 1517 patients in 23 Dutch PM centers were followed for a mean of 5.8 years (SD 1.1), resulting in 8797 patient-years. Within 2 months, 188 (12.4%) patients developed PM complications. Male gender, age at implantation, body mass index, a history of cerebrovascular accident, congestive heart failure, use of anticoagulant drugs, and passive atrial lead fixation were independent predictors for complications within 2 months, yielding a C-index of 0.62 (95% confidence interval 0.57-0.66). Annual hospital implanting volume did not additionally contribute to the prediction of short-term complications. Thereafter, 140 (9.2%) patients experienced complications, mostly lead-related complications (n = 84). Independent predictors for long-term complications were age, body mass index, hypertension, and a dual-chamber device, yielding a C-index of 0.62 (95% confidence interval 0.57-0.67). The occurrence of a short-term PM complication was not predictive of future PM complications. Complication incidence in modern pacing therapy is still substantial. Most complications occur early after PM implantation. Although various patient- and procedure-related characteristics are independent predictors for early and late complications, their ability to identify the patient at high risk is rather poor. This relatively high incidence of PM complications and their poor prediction underscores the usefulness of current guidelines for regular follow-up of patients with PM. Copyright © 2012 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.
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              Early performance of a miniaturized leadless cardiac pacemaker: the Micra Transcatheter Pacing Study

              Philippe Ritter, Gabor Duray, Clemens Steinwender … (2015)
              Aims Permanent cardiac pacing is the only effective treatment for symptomatic bradycardia, but complications associated with conventional transvenous pacing systems are commonly related to the pacing lead and pocket. We describe the early performance of a novel self-contained miniaturized pacemaker. Methods and results Patients having Class I or II indication for VVI pacing underwent implantation of a Micra transcatheter pacing system, from the femoral vein and fixated in the right ventricle using four protractible nitinol tines. Prespecified objectives were >85% freedom from unanticipated serious adverse device events (safety) and <2 V 3-month mean pacing capture threshold at 0.24 ms pulse width (efficacy). Patients were implanted (n = 140) from 23 centres in 11 countries (61% male, age 77.0 ± 10.2 years) for atrioventricular block (66%) or sinus node dysfunction (29%) indications. During mean follow-up of 1.9 ± 1.8 months, the safety endpoint was met with no unanticipated serious adverse device events. Thirty adverse events related to the system or procedure occurred, mostly due to transient dysrhythmias or femoral access complications. One pericardial effusion without tamponade occurred after 18 device deployments. In 60 patients followed to 3 months, mean pacing threshold was 0.51 ± 0.22 V, and no threshold was ≥2 V, meeting the efficacy endpoint (P < 0.001). Average R-wave was 16.1 ± 5.2 mV and impedance was 650.7 ± 130 ohms. Conclusion Early assessment shows the transcatheter pacemaker can safely and effectively be applied. Long-term safety and benefit of the pacemaker will further be evaluated in the trial. Clinical Trial Registration ClinicalTrials.gov ID NCT02004873.
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                Author and article information

                Contributors
                Valentina De Regibus:
                ORCID: http://orcid.org/0000-0001-5221-464X
                valentina.deregibus@gmail.com
                Journal
                Journal ID (nlm-ta): Clin Case Rep
                Journal ID (iso-abbrev): Clin Case Rep
                Journal ID (doi): 10.1002/(ISSN)2050-0904
                Journal ID (publisher-id): CCR3
                Title: Clinical Case Reports
                Publisher: John Wiley and Sons Inc. (Hoboken )
                ISSN (Electronic): 2050-0904
                Publication date (Electronic): 19 April 2018
                Publication date Collection: June 2018
                Volume: 6
                Issue: 6 ( doiID: 10.1002/ccr3.2018.6.issue-6 )
                Pages: 1106-1108
                Affiliations
                [ 1 ] GVM Care&Research Maria Cecilia Hospital Cotignola Italy
                [ 2 ] GVM Care&Research Città di Lecce Hospital Lecce Italy
                [ 3 ] GVM Care&Research Anthea Hospital Bari Italy
                Author notes
                [*] [* ] Correspondence

                Valentina De Regibus, GVM Care&Research Via Corriera, Maria Cecilia Hospital, 1 Cotignola‐ 48033 RA, Italy. Tel: +39 0545 217111; Fax: +390545217108; E‐mail: valentina.deregibus@ 123456gmail.com

                Author information
                http://orcid.org/0000-0001-5221-464X
                Article
                Publisher ID: CCR31532
                DOI: 10.1002/ccr3.1532
                PMC ID: 5986052
                PubMed ID: 29881575
                SO-VID: 90787344-e9e3-4a02-9f87-a0f61d587930
                Copyright © © 2018 The Authors. Clinical Case Reports published by John Wiley & Sons Ltd.
                License:

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 29 November 2017
                Date revision received : 08 March 2018
                Date accepted : 14 March 2018
                Page count
                Figures: 1, Tables: 0, Pages: 3, Words: 1482
                Categories
                Subject: Case Report
                Subject: Case Reports
                Custom metadata
                source-schema-version-number 2.0
                component-id ccr31532
                cover-date June 2018
                details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_NLMPMC version:version=5.4.0 mode:remove_FC converted:04.06.2018

                Keywords: dextrocardia,leadless pacemaker,situs viscerum inversus,transvenous lead extraction
                Data availability:
                Keywords: dextrocardia, leadless pacemaker, situs viscerum inversus, transvenous lead extraction

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