Mortality and 30-Day Readmission Rates After Inpatient Leadless Pacemaker Implantation: Insights From a Nationwide Readmissions Database

Tonegawa‐Kuji, Reina; Kanaoka, Koshiro; Mori, Makoto; Nakai, Michikazu; Iwanaga, Yoshitaka

doi:10.1016/j.cjca.2022.08.002

Cited by 12 publications

(4 citation statements)

References 15 publications

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“…After adjustment for patient comorbidities, in-hospital mortality post-CIED implantation was similar between Japan and the USA, except for leadless pacemaker recipients. Consistent with previous reports, 26 27 in-hospital mortality and complication rates for leadless pacemaker recipients in NRD were relatively high, but they revealed a decreasing trend overtime. These changes are likely due to the operator’s learning curve, which has been reported as an important factor for quality of leadless pacemaker implantation.…”

Section: Discussionsupporting

confidence: 90%

Differences in patient characteristics, clinical practice and outcomes of cardiac implantable electric device therapy between Japan and the USA: a cross-sectional study using data from nationally representative administrative databases

et al. 2023

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ObjectivesTo identify differences in patient characteristics, clinical practice and outcomes of cardiac implantable electronic device (CIED) therapy between Japan and the USA.DesignA cross-sectional study.SettingNationally representative administrative databases from Japan and the USA containing hospitalisations with first-time implantations of pacemakers, implantable cardioverter-defibrillators (ICD) and cardiac-resynchronisation therapy with or without defibrillators (CRTP/CRTD).ParticipantsPatients hospitalised with first-time implantations of CIEDs.Outcome measuresIn-hospital mortality, in-hospital complication and 30-day readmission rates.ResultsOverall, 107 339 (median age 78 (71–84), 48 415 women) and 295 584 (age 76 (67–83), 127 349 women) records with CIED implantations were included from Japan and the USA, respectively. Proportion of women in defibrillator recipients was lower in Japan than in the USA (ICD, 21% vs 28%, p<0.001; CRTD, 24% vs 29%, p<0.001). Length of stay after CIED implantation was longer in Japan than in the USA for all device types (conventional pacemaker, 8(7–11) vs 1 (1–3) days, p<0.001; leadless pacemaker, 5 (3–9) vs 2 (1–5) days, p<0.001; ICD, 8 (7–11) vs 1 (1–3) days, p<0.001, CRTP, 9 (7–13) vs 2 (1–4) days, p<0.001; CRTD, 9 (8–14) vs 2 (1–4) days, p<0.001). In-hospital mortality after CIED implantation was similar between Japan and the USA ((OR) (95% CI), conventional pacemaker 0.58 (0.83 to 1.004); ICD 0.77 (0.57 to 1.03); CRTP 0.85 (0.51 to 1.44); CRTD 1.11 (0.81 to 1.51)), except that after leadless pacemaker implantation in Japan was lower than that in the USA (0.32 (0.23 to 0.43)). 30-day readmission rates were lower in Japan than in the USA for all device types (conventional pacemaker 0.55 (0.53 to 0.57); leadless pacemaker 0.50 (0.43 to 0.58); ICD 0.54 (0.49 to 0.58); CRTP 0.51 (0.42 to 0.62); CRTD 0.57 (0.51 to 0.64)).ConclusionsInternational variations in patient characteristics, practice and outcomes were observed. In-hospital mortality after CIED implantation was similar between Japan and the USA, except in cases of leadless pacemaker recipients.

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Section: Discussionsupporting

confidence: 90%

Differences in patient characteristics, clinical practice and outcomes of cardiac implantable electric device therapy between Japan and the USA: a cross-sectional study using data from nationally representative administrative databases

et al. 2023

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“…Elderly or malnourished patients with high infectious risk are prone to choosing LPMs [ 17 , 18 ]. Patients on haemodialysis would benefit from LPM implantation because it spares the subclavian and superior cava veins for dialysis treatment.…”

Section: Leadless Ventricular Pacemakersmentioning

confidence: 99%

“…A continuous enrollment study and contemporaneous comparison of the Micra and TPMs in the Micra Coverage with Evidence Development (CED) study observed that the Micra implantation was associated with 23% fewer and 31% fewer complications compared with TPMs over 6 months [ 26 ] and 2 years [ 9 ], respectively, indicating that the fewer LPM complications were due to a time-dependent effect, which was also manifested by the improved LPM complication rates from the 6 month follow-up to the 2 year follow-up, and the similar 30 day adjusted complication rate of LPMs to that of TPMs [ 26 ]. A large and real-world analysis of the national database from the United States showed that, overall, the unadjusted in-hospital complication rate of 16% for LPMs was higher than that of the 6.4% for TPMs; however, it should be noted that the patients with LPMs in this analysis were older and had more sepsis, chronic kidney disease, heart failure and malnutrition [ 18 ]. Transvenous lead- and subcutaneous-pocket-related complications account for most of these TPM complications [ 3 , 4 ], and they take time to occur.…”

Section: Leadless Ventricular Pacemakersmentioning

confidence: 99%

“…The Manufacturer and User Facility Device Experience (MAUDE) report also estimated a 1% incidence of cardiac tamponade, and more than three times the cardiac tamponade of the Micra compared with the TPM ventricular lead [ 28 ]. In a real-world setting, 1.3% of LPM recipients suffered from cardiac effusion or perforation [ 18 ], and the figure was significantly higher than that of TPM recipients [ 25 ]. Similarly, as for Aveir VR implantation, the rate of cardiac tamponade was 1.5% (3/200) in the LEADLESS II-phase 2 IDE study [ 12 ].…”

Section: Leadless Ventricular Pacemakersmentioning

confidence: 99%

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Strategies for Safe Implantation and Effective Performance of Single-Chamber and Dual-Chamber Leadless Pacemakers

Tong

Sun

2023

JCM

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Leadless pacemakers (LPMs) have emerged as an alternative to conventional transvenous pacemakers to eliminate the complications associated with leads and subcutaneous pockets. However, LPMs still present with complications, such as cardiac perforation, dislodgment, vascular complications, infection, and tricuspid valve regurgitation. Furthermore, the efficacy of the leadless VDD LPMs is influenced by the unachievable 100% atrioventricular synchrony. In this article, we review the available data on the strategy selection, including appropriate patient selection, procedure techniques, device design, and post-implant programming, to minimize the complication rate and maximize the efficacy, and we summarize the clinical settings in which a choice must be made between VVI LPMs, VDD LPMs, or conventional transvenous pacemakers. In addition, we provide an outlook for the technology for the realization of true dual-chamber leadless and battery-less pacemakers.

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Real-World Use of Leadless Pacing: Lessons Learned

Philippon

2022

Canadian Journal of Cardiology

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Mortality and 30-Day Readmission Rates After Inpatient Leadless Pacemaker Implantation: Insights From a Nationwide Readmissions Database

Cited by 12 publications

References 15 publications

Differences in patient characteristics, clinical practice and outcomes of cardiac implantable electric device therapy between Japan and the USA: a cross-sectional study using data from nationally representative administrative databases

Differences in patient characteristics, clinical practice and outcomes of cardiac implantable electric device therapy between Japan and the USA: a cross-sectional study using data from nationally representative administrative databases

Strategies for Safe Implantation and Effective Performance of Single-Chamber and Dual-Chamber Leadless Pacemakers

Real-World Use of Leadless Pacing: Lessons Learned

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