Systematic Review and Meta-Analysis of Acute Mortality and Complication Rates Following Leadless Pacemaker Placement Using National-Level Data
Abstract
1. Introduction
2. Materials and Methods
2.1. Search Strategy
2.2. Eligibility Criteria
2.3. Selection of Studies and Data Extraction
2.4. Meta-Analysis Strategy
2.5. Risk of Bias and Certainty of Evidence Assessment
3. Results
3.1. Included Study Characteristics
3.2. LPM vs. TPM Placement Outcome Data
3.3. Risk of Bias and Certainty of Evidence Assessment
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Abbreviations
GRADE | Grading of Recommendations Assessment, Development, and Evaluation |
IQR | Interquartile range |
LPM | Leadless pacemaker |
OR | Odds ratio |
PMSI | Programme de Médicalisation des Systèmes d’Information |
SD | Standard deviation |
TPMs | Transvenous pacemakers |
USA | United States of America |
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Study | Country | Database Name | Period | Sample Size | Age Mean ± SD or Median (IQR) | Objective | ||
---|---|---|---|---|---|---|---|---|
LPM | TPM | LPM | TPM | |||||
Piccini, 2021 [31] | USA | Medicare Claims Data | 9 March 2017–1 December 2018 | 3726 | 7265 | 79.4 ± 9.5 | 82.0 ± 8.1 | 30-day and 6-month complication rates |
Bodin, 2022 [32] | France | PMSI | 1 January 2017–1 September 2020 | 1487 | 40,828 | 70.7 ± 18.4 | 83.4 ± 9.1 | 30-day complication rate, including all-cause death and cardiovascular death |
Tonegawa-Kuji, 2022 [33] | USA | Nationwide Readmissions Database | April 2017–December 2019 | 5986 | 131,746 | 79 (70–86) | 78 (70–85) | In-hospital complications and 30-day readmission |
Alhuarrat, 2023 [34] | USA | National Inpatient Sample Database | 2016–2019 | 7780 | 27,650 | 77.1 ± 12.1 | 81.3 ± 9.4 | In-hospital outcome and procedural complications |
Crossley, 2024 [35] | USA | Medicare Claims Data | 5 February 2020–1 December 2021 | 7471 | 107,800 | 79.0 ± 10.2 | 78.7 ± 8.0 | 30 days and 6 months overall and device-related complications, and all-cause mortality |
Study | Complication Assessment Period | Acute Complications |
---|---|---|
Piccini, 2021 [31] | 30-day | Embolism and thrombosis, puncture site events, cardiac effusion and perforation, device-related, and other complications. |
Bodin, 2022 [32] | In-hospital | Embolism and thrombosis, puncture site events, cardiac effusion and perforation, device-related, and other complications. |
Tonegawa-Kuji, 2022 [33] | 30-day | Cardiac tamponade, pneumothorax, hemothorax, major bleeding, transfusion, and device-related complications. |
Alhuarrat, 2023 [34] | In-hospital | Bleeding, vascular events, venous thromboembolism, device-related, cardiac, pulmonary, infection, and neurologic complications. |
Crossley, 2024 [35] | 30-day | Embolism and thrombosis, puncture site events, cardiac effusion and perforation, device-related, and other complications. |
Authors | Question | Recruitment | Exposure | Outcome | Confounding | Follow up | Results | Applicability | Fit | Implications | Score |
---|---|---|---|---|---|---|---|---|---|---|---|
Piccini, 2021 [31] | Yes | Yes | Yes | Yes | Cannot t tell | Yes | Yes | Yes | Cannot tell | Yes | 9.0 |
Bodin, 2022 [32] | Yes | Yes | Yes | Yes | Cannot tell | Yes | Yes | Yes | Cannot tell | Yes | 9.0 |
Tonegawa-Kuji, 2022 [33] | Yes | Yes | Yes | Yes | Cannot tell | Yes | Yes | Cannot tell | Cannot tell | Yes | 8.5 |
Alhuarrat, 2023 [34] | Yes | Yes | Yes | Yes | Cannot tell | Can’t tell | Yes | Yes | Cannot tell | Yes | 8.5 |
Crossley, 2024 [35] | Yes | Yes | Yes | Yes | Cannot tell | Yes | Yes | Yes | Cannot tell | Yes | 9.0 |
Outcome | Risk of Bias | Inconsistency | Indirectness | Imprecision | Publication Bias | Certainty of Evidence |
---|---|---|---|---|---|---|
Acute mortality | Low | Serious | Not serious | Serious | Not assessed | Low |
Acute overall complications | Low | Serious | Not serious | Serious | Not assessed | Low |
Acute device-related complications | Low | Serious | Not serious | Serious | Not assessed | Low |
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Sarsenbayeva, A.; Baimbetov, A.; Puodziukynas, A.; Baimakhanov, B.; Sapunov, A.; Bizhanov, K. Systematic Review and Meta-Analysis of Acute Mortality and Complication Rates Following Leadless Pacemaker Placement Using National-Level Data. Medicina 2025, 61, 974. https://doi.org/10.3390/medicina61060974
Sarsenbayeva A, Baimbetov A, Puodziukynas A, Baimakhanov B, Sapunov A, Bizhanov K. Systematic Review and Meta-Analysis of Acute Mortality and Complication Rates Following Leadless Pacemaker Placement Using National-Level Data. Medicina. 2025; 61(6):974. https://doi.org/10.3390/medicina61060974
Chicago/Turabian StyleSarsenbayeva, Akmoldir, Adil Baimbetov, Aras Puodziukynas, Bolatbek Baimakhanov, Alexander Sapunov, and Kenzhebek Bizhanov. 2025. "Systematic Review and Meta-Analysis of Acute Mortality and Complication Rates Following Leadless Pacemaker Placement Using National-Level Data" Medicina 61, no. 6: 974. https://doi.org/10.3390/medicina61060974
APA StyleSarsenbayeva, A., Baimbetov, A., Puodziukynas, A., Baimakhanov, B., Sapunov, A., & Bizhanov, K. (2025). Systematic Review and Meta-Analysis of Acute Mortality and Complication Rates Following Leadless Pacemaker Placement Using National-Level Data. Medicina, 61(6), 974. https://doi.org/10.3390/medicina61060974