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Rapid Communication|Articles in Press

Pacing failure of leadless pacemaker caused by fractured tines

Open AccessPublished:March 17, 2023DOI:https://doi.org/10.1016/j.hrcr.2023.03.007

      Keywords

      Introduction

      Leadless pacemakers (LLPM) have a low incidence of complications and good electrical performance. Although LLPM has a passive fixation mechanism using tines, the dislodgement issues remain a safety concern for patients. Here, we report the first case with pacing failure caused by tines fracture.

      Case report

      An 81-year-old man with a syncopal attack was referred to our hospital for the treatment of complete heart block. The echocardiography revealed normal left ventricular ejection fraction and no evidence of cardiac hypertrophy, atrial enlargement, intracardiac thrombus, or infiltrative disease. The chamber sizes were normal for body surface area, although there was a mild diastolic dysfunction with impaired relaxation pattern. The patient remained relatively active (height 160 cm, weight 60 kg, BMI 23.4, frailty score 5), but had thrombocytopenia with a platelet count of 36,000/μ L and diabetes mellitus. The LLPM (Micra AVTM) was selected with concerns over the possible difficulty in hemostasis. The femoral veins tortuousity and anatomical abnormalities of the heart were excluded by venography and right ventriculography. (Figure 1-A, 1-B) LLPM was successfully implanted in the right ventricular mid-septum on the first attempt, with a capture threshold of 1.00 V at 0.24 ms, R wave amplitude of 5.5 mV, and pacing impedance of 480 ohms. (Figure 1-C, 1-D) The engagement of the device was confirmed with the standard pull and hold test, showing at least three of the four tines were fixed. However, pacing threshold obtained by remote monitoring increased gradually two months after the implantation. The device parameters did not change significantly between initial implantation and final measurement except for a capture threshold. (a capture threshold of 1.00V at 0.24 ms to 4.63V at 0.24 ms, pacing impedance of 480ohms to 400 ohms, R wave amplitude of 5.5mV to 6.8mV, A4 amplitude of 2.8m/s2 to 5.1m/s2 respectively). The patient presented to our hospital with fatigue at 6 months after implantation. Intermittent pacing failure was observed even at maximal pacing output. (Figure 2-A) Fluoroscopy showed that two of tines were fractured, one of which was completely isolated from Micra and buried in myocardium. (Figure 2-B, red arrow, Supplementary Movie) Since the LLPM body was well fixed with the remaining two tines, device removal was avoided. As the platelet count was recovered from 36,000/μ L to 61,000/μ L, the reoperation with a transvenous pacemaker (TVPM) was performed with no complications.
      Figure thumbnail gr1
      Figure 1-A, 1-BAnatomical abnormalities of the heart were excluded by right ventriculography in right anterior oblique (RAO) and left anterior oblique (LAO) view. ; The contrast from the device tip confirmed device engagement with and near tissue.
      Figure thumbnail gr2
      Figure 2-AThe intermittent pacing failure was observed in 12 leads electrocardiogram even at maximal pacing output., ; The fluoroscopy showed that two of tines were fractured, one of which was completely isolated from Micra and buried in myocardium.

      Discussion

      To our knowledge, this is the first report of pacing failure caused by LLPM tines fracture. LLPM has been reported with a low risk of complications and good electrical performance. In a systematic review and meta-analysis, the incidence of complications at 90 days was 0.46% (95% CI, 0.08%–1.05%) and at 1 year was 1.77% (95% CI, 0.76%–3.07%) respectively. At 1 year, 98.96% (95% CI, 97.26%–99.94%) of 1376 patients had good pacing capture thresholds. [

      Linh Ngo, Daniel Nour, Russell A Denman, et al. Safety and Efficacy of Leadless Pacemakers: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2021 Jul 6; 10(13): e019212.

      ] In an investigational device exemption study, the dislodgement of LLPM was observed in 0.13% of patients in 30 days after implantation, with no tine fracture observed at 1 year follow-up. [

      Paul R Roberts, Nicolas Clementy, Faisal Al Samadi, et al. A leadless pacemaker in the real-world setting: The Micra Transcatheter Pacing System Post-Approval Registry. Heart Rhythm. 2017 Sep; 14(9): 1375-1379.

      ]
      The selection of LLPM or TVPM for the treatment of bradycardia is an important issue. Although numerous developments have augmented pacemaker design and functionality, TVPM is still associated with a significant number of complications (8%-12%), mostly related to the transvenous lead or subcutaneous pocket. [
      • Udo EO
      • Zuithoff NP
      • van Hemel NM
      • et al.
      Incidence and predictors of short- and long-term complications in pacemaker therapy: the FOLLOWPACE study.
      ] The LLPM eliminates complications associated with transvenous leads and pockets and improves pacing therapy. The complication rate was significantly lower in LLPM than TVPM (0.9% vs 4.7%) at 800 days of follow-up. [4] The reasons for choosing LLPM at the initial procedure in this case were as follows; the patient was relatively elderly; the indication of pacemaker was complete heart block and the Micra AVTM is capable of atrioventricular synchronization; the generator pocket hematomas of TVPM could lead to serious device infection, while femoral vein puncture site hematomas were less likely.
      This case demonstrated an extremely rare phenomenon of pacing failure caused by LLPM tines fracture. Although the precise mechanism of tines fracture is unclear, electrophysiologists should be made aware of this phenomenon.

      Uncited reference

      [

      Tjong FVY, Knops RE, Udo EO, et al. Leadless pacemaker versus transvenous single-chamber pacemaker therapy: A propensity score-matched analysis. Heart Rhythm. 2018 Sep; 15(9): 1387-1393.

      ].

      Supplementary Data

      Reference

      1. Linh Ngo, Daniel Nour, Russell A Denman, et al. Safety and Efficacy of Leadless Pacemakers: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2021 Jul 6; 10(13): e019212.

      2. Paul R Roberts, Nicolas Clementy, Faisal Al Samadi, et al. A leadless pacemaker in the real-world setting: The Micra Transcatheter Pacing System Post-Approval Registry. Heart Rhythm. 2017 Sep; 14(9): 1375-1379.

        • Udo EO
        • Zuithoff NP
        • van Hemel NM
        • et al.
        Incidence and predictors of short- and long-term complications in pacemaker therapy: the FOLLOWPACE study.
        Heart Rhythm. 2012 May; 9: 728-735
      3. Tjong FVY, Knops RE, Udo EO, et al. Leadless pacemaker versus transvenous single-chamber pacemaker therapy: A propensity score-matched analysis. Heart Rhythm. 2018 Sep; 15(9): 1387-1393.