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    Interventional procedure overview of leadless cardiac pacemaker implantation for bradyarrhythmias

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    Addendum – Additional evidence considered by the Interventional Procedures Advisory Committee on 11 September 2025, after the draft guidance consultation period

    As part of the usual process for producing interventional procedures guidance, an updated literature search was done on 21 July 2025, during the consultation period. Relevant key studies that were published since the original search were identified and the data was extracted into additional evidence tables, which are shown below (tables 6 to 9). This was presented at the Interventional Procedures Advisory Committee meeting on 11 September 2025, along with consultation comments that were submitted on the draft guidance.

    There were 4 additional key studies considered by the committee. Two focused on a dual chamber leadless pacemaker system (Knops 2025, Reddy 2025) and 2 focused on atrial pacing either as a standalone therapy or as part of a dual chamber leadless pacemaker system (Nair 2025, von Felten 2025).

    In addition to the 4 key studies that were presented in detail, there were a further 25 relevant studies identified that were not prioritised. These are listed in table 10 below.

    Study details and outcomes for additional evidence

    Dual chamber leadless pacing

    Table 6 Study details

    Study no.

    First author, date

    country

    Characteristics of people in the study (as reported by the study)

    Study design

    Inclusion criteria

    Intervention

    Follow up

    17

    Knops, 2025

    (USA, Canada, Europe)

    n=300

    Mean age=69.2 years

    Male: Not specified

    Indications:

    Sinus node dysfunction: 63.3% (190/300)

    Atrioventricular block: 33.3% (100/300)

    Other: 3.4% (10/300)

    Comorbidities:

    Not reported

    Prospective, multicentre, single arm study.

    Adults 18 years and over with at least 1 standard indication for dual chamber pacing according to US or EU guidelines.

    Exclusion: mechanical tricuspid valve prosthesis, inferior vena cava filter, pre-existing leads, other electrically active implantable devices.

    AVEIR DR dual-chamber leadless pacemaker system:

    Both devices with active fixation helix.

    Bidirectional i2i communication for AV synchrony.

    Percutaneous delivery via femoral vein.

    Mean 12 months

    18

    Reddy, 2025

    Multi-centre (USA, Canada, Europe, Asia-Pacific)

    n=302

    Mean age=70.3 years

    Male: 65% (197/302)

    Indications:

    Sinus node dysfunction: 57.9% (175/302)

    AV block, 3rd degree: 15.6% (47/302)

    Other: 15.6% (47/302)

    AV block, 2nd degree: 6.3% (19/302)

    AV block, 1st degree: 4.6% (14/302).

    Comorbidities (values are shown as percent or mean):

    History of atrial fibrillation: 33.4% (101/302), body surface area: 1.9 m², weight: 80.0 kg, height: 170.4 cm, ejection fraction: 59.8%, intrinsic heart rate: 55.4 beats per minute.

    Prospective, multicentre, international clinical trial (post hoc analysis).

    Standard indications for dual-chamber pacing, de novo dual-chamber LP implants, no subsequent device revision, dual-chamber pacing programmed (DDD(R) or DDI(R)), complete longevity measurements at 12 months.

    Exclusion criteria: mechanical tricuspid valve prosthesis, inferior vena cava filter, pre-existing pacing/defibrillation leads, or electrically active implantable devices.

    AVEIR DR dual-chamber leadless pacemaker system

    Both use Li-CFx battery technology and implant to implant communication for AV synchrony.

    12 months post-implant.

    Table 7 study outcomes

    Author date

    Efficacy outcomes

    Safety outcomes

    Knops, 2025

    Implantation success (with established implant to implant communication): 98.3% (295/300) Unsuccessful atrial implants: n=2

    Inadequate implant to implant communication: n=3.

    Primary performance endpoint:

    Atrial capture threshold 3.0 volts or less at 0.4 ms and sensing amplitude P-wave 1.0 millivolts or higher at 12 months: 92.8% (95% CI: 89.7 to 95.8).

    Performance goal: >80.0% (p<0.001).

    Atrial electrical performance success at 3 months: 90.2%.

    Atrial device performance at 12 months, mean (SD):

    Capture threshold: 0.83 (0.62) volts at 0.4 ms

    P-wave amplitude: 3.51 (1.87) millivolts

    Impedance: 312 (48) ohms, decline from 331 (68) ohms at implantation.

    Implant to implant communication at 12 months:

    Ventricular-to-atrial success: 87.5%

    Atrial-to-ventricular success: 90.3%.

    AV synchrony success at 3 months: 97.3%.

    Battery longevity at 12 months, mean (SD):

    Atrial device remaining longevity: 5.4 (4.0) years (95% CI 4.9 to 5.9)

    Ventricular device remaining longevity: 10.3 (5.5) years (95% CI 9.6 to 11.0)

    Programming-specific longevity:

    • Single-chamber mode sub-cohort (18.5%):

    Atrial: mean 8.9 years (95% CI 6.7 to 11.1)

    Ventricular: mean 18.1 years (95% CI 15.9 to 20.4).

    • Dual-chamber mode only:

    Atrial: mean 4.7 years (95% CI 4.4 to 5.0)

    Ventricular: mean 8.7 years (95% CI 8.3 to 9.1).

    Indication specific longevity:

    • Sinus node dysfunction: atrial 5.3 years, ventricular 11.6 years

    • AV block: atrial 5.8 years, ventricular 7.9 years.

    Primary Safety Endpoint:

    12-month complication-free rate: 88.6% (95% CI 84.5 to 91.8)

    Performance goal: more than 76.5% (p<0.001).

    3-month complication-free rate: 90.3%.

    Complication rate at 12 months: 11.3% (n=34/300, 41 events).

    Timing of complications:

    Within 2 days: 68.3% of all complications (28 events, n=24 people)

    3 to 90 days: 7 additional complications (7 people)

    91 to 365 days: 6 new complications (6 people, 2.0%).

    Complications: 11.3% (41 events in 34 people)

    Cardiac arrhythmia (mostly AF): 3.3% (n=10)

    Device dislodgement: 3.4%

    Intra-procedural dislodgement: 1.7% (n=6)

    Post-procedural dislodgement: 1.7% (n=5)

    Capture threshold issues: 1.3% (n=4)

    Pericardial effusion: 0.7% (n=2)

    Urinary retention: 1.0% (n=3)

    Threshold elevation: n=2

    Heart failure: n=2

    Oral pain: n=1

    Pleural effusion: n=1

    Presyncope: n=1

    Syncope: n=1

    Haematoma: n=1

    Access site bleeding: n=1

    Oversensing: n=1

    Inappropriate magnet mode: n=1 (firmware updated).

    Device revisions (all successful): n=14

    LP replacement in 9

    CRT-P device in 2

    Transvenous dual chamber in 1

    No replacement device in 2

    Indications for revision were atrial device dislodgement (in 6), suboptimal implant-to-implant communication (in 1), and intermittent ventricular capture (in 1), threshold elevation of one or both devices (in 3), a change in medical condition (in 2), and mechanical dislodgement of the atrial device during cardiac surgery (in 1).

    Deaths (not procedure or device related): 2.7% (8/300)

    4 were within 90 days and 4 happened between 251 and 341 days.

    Reddy, 2025

    (Aveir DR i2i Study, NCT05252702)

    Battery longevity at 12 months (values are shown as median and IQR):

    Atrial leadless pacemaker (ALP) remaining longevity: 4.3 years [3.5, 5.1]

    ALP total longevity: 5.3 years [4.4, 6.1]

    Ventricular leadless pacemaker (VLP) remaining longevity: 9.1 years [6.8, 10.7]

    VLP total longevity: 9.9 years [7.7, 11.7].

    Programmed parameters at 12 months

    DDD mode: 65.2% (197/302)

    DDDR mode: 33.4% (101/302)

    DDI/DDIR mode: 1.4% (4/302)

    Median base rate: mean 60 beats per minute [IQR 50, 60]

    Rate-response disabled: 65.6% (198/302)

    ALP pulse amplitude: mean 1.25 volts [IQR 1.25, 2.0] (87.7% at 0.4 ms pulse width)

    VLP pulse amplitude: mean 1.5 volts [IQR 1.25, 2.0] (93.7% at 0.4 ms pulse width)

    ALP-to-VLP implant to implant communication (i2i) setting: mean 5 [IQR 4, 6] out of 7

    VLP-to-ALP i2i setting: mean 5 [IQR 4, 6] out of 7

    Device Performance at 12 months (values are shown as median and IQR):

    ALP pacing percentage: 20.5% [3.0, 56.0]

    VLP pacing percentage: 15.0% [2.0, 80.0]

    ALP event rate: 67.9 events per minute [61.0, 74.9]

    VLP event rate: 67.0 events per minute [60.3, 73.4]

    ALP impedance: 310 ohms [280, 340]

    VLP impedance: 600 ohms [500, 702].

    Longevity impact factors:

    Base rate, pulse amplitude, pacing percentage, event rate, impedance, and i2i setting level all exhibited significant correlations with ALP and VLP longevities (p<0.001). Programming i2i setting levels below 7 produced the greatest longevity savings.

    Device revisions before 12 months: 5.4% (24/446)

    Dislodgement: n=13 (11 VLP and 2 ALPs)

    Capture threshold elevation: n=7 (in 2 ALP, 4 VLP and both in 1 person).

    Implant to implant communication issue: n=1

    Upgrade to CRT-P: n=2.

    Atrial leadless pacing (either as single chamber pacing or as part of a dual chamber leadless pacing)

    Table 8 Study details

    Study no.

    First author, date

    country

    Characteristics of people in the study (as reported by the study)

    Study design

    Inclusion criteria

    Intervention

    Follow up

    19

    Nair, 2025

    USA

    n=75

    Mean age=72.1 years

    Male: 52.0% (39/75)

    Indications:

    Sinus node dysfunction: 100% (75/75)

    Comorbidities:

    Hypertension: 73.3% (55/75), coronary artery disease: 42.7% (32/75), diabetes mellitus: 40.0% (30/75), atrial fibrillation: 38.7% (29/75), chronic kidney disease: 37.3% (28/75), and congestive heart failure: 14.7% (11/75).

    Prospective, multicentre, single-arm study.

    Age18 and over with sick sinus syndrome or sinus node dysfunction meeting standard criteria for permanent pacemaker implantation (per AHA guidelines), without clinical evidence of high-grade AV block, scheduled for Aveir AR pacemaker implantation.

    AVEIR AR atrial leadless pacemaker:

    De novo implants: 92.0% (69/75)

    Replacing dual-chamber transvenous device: 8.0% (6/75).

    Dual-helix fixation mechanism.

    30 days

    20

    von Felten, 2025, Switzerland

    n=45

    Mean age=75.5 years

    Male: 48.9%

    Indications:

    AV-block: 57.8% (26/45)

    Sick sinus syndrome: 33.3% (15/45)

    Binodal disease: 6.7% (3/45)

    Pace-and-ablate: 2.2% (1/45)

    Comorbidities % (n):

    Hypertension: 66.7 (30/45), dyslipidaemia: 46.7 (21/45), chronic kidney disease: 35.6 (16/45), atrial fibrillation: 33.3 (15/45), diabetes: 20.0 (9/45), heart failure: 13.3 (6/45), coronary artery disease: 13.3 (6/45), cerebrovascular disease: 13.3 (6/45), malignancy: 13.3 (6/45), valvular heart disease: 8.9 (4/45), COPD: 4.4 (2/45), sleep apnoea: 4.4 (2/45).

    Prospective, single-centre study

    Adults having implantation of active fixation single chamber atrial LP (AR) or dual chamber LP system (DR) from July 2024 to January 2025 who consented to study inclusion.

    AVEIR leadless pacemaker system:

    dual chamber: 48.9% (22/45).

    Upgrade from ventricular device (VR) single chamber to dual chamber system (DR): 20% (9/45)

    Atrial single chamber (AR) only: 31.1% (14/45)

    Active fixation with external helix, wireless communication via i2i technology.

    Median follow-up: 21 days

    Table 9 Study outcomes

    Author, date

    Efficacy outcomes

    Safety outcomes

    Nair, 2025

    Implantation success: 100% (75/75)

    Total procedure duration: mean 36.3 minutes.

    LP implant duration (from insertion to removal of catheter): mean 21.6 minutes.

    De novo implants procedure time (which did not include existing transvenous hardware removal): mean 32.3 minutes.

    Device positioning:

    Right atrial appendage base: 82.7%

    Posterior base of appendage: 42.7%

    Anterior base of appendage: 33.3%

    Free wall: 12.0%

    Mid-to-deep appendage: 3.0%

    Bachmann's bundle: 1.3%.

    Device performance, mean (SD):

    Pacing capture threshold (PCT) during prefixation=1.1 (1.1) volts improved at discharge to 0.6 (0.6) volts, p<0.001. 91.5% of people had PCT 3.0 volts or less at release and this improved at discharge to 98.6%.

    Sensed amplitudes during prefixation=2.1 (1.0) millivolts improved by discharge to 2.9 (1.5) millivolts, p<0.001. 94.7% of people had sense amplitude 1.0 millivolts or higher at LP release and this improved at discharge to 100%.

    Pacing impedance at prefixation=315 (44) ohms and remained stable at mapping, release and discharge at 329 (46) ohms

    Acute procedural complications: 0

    Repositioning rate: 5.3% (4/75)

    (in 1 person repositioning was done because leadless pacemaker could not be released from the catheter and in 3 people repositioning was done twice because of inadequate electric parameters).

    No repositioning needed in 94.7% (71/75).

    30-day complications: 0

    There were no perforations, device dislodgements, pacing or sensing changes needing reintervention, groin haematomas, vascular complications, pericardial effusions or tamponade.

    von Felten, 2025

    Implantation success: 100% (45/45)

    Median procedure time

    Overall: 30 minutes (IQR 25 to 35)

    Atrial device (AR) only (n=14): 25 minutes

    De novo dual chamber system (DR) (n=22): 35 minutes

    DR upgrade (from ventricular device-VR to DR) (n=9): 30 minutes

    Device positioning:

    AR: 100% at right atrial appendage base

    VR: 67.7% Midseptal; 22.5% inferoseptal, 9.7% anteroseptal.

    Electric performance

    Median impedance

    AR: was 340 ohms (IQR 290 to 380, n=45) at implantation, which improved to 310 ohms (IQR 295 to 340, n=44) at follow-up (median 21 days).

    VR: was 820 ohms (IQR 757.5 to 1140, n=28) at implantation, which improved to 710 ohms (IQR 555 to 850, n=31) at follow-up.

    Median sensing

    AR: was 1.5 millivolts (IQR 1.0 to 2.3, n=44) at implantation, which improved to 3.75 millivolts (IQR 2.7 to 4.7, n=44) at follow-up.

    VR: was 5.25 millivolts (IQR 3.6 to 7.9, n=26) at implantation, which improved to 10.1 millivolts (IQR 8.41 to 2.9, n=24) at follow-up.

    Median PCT

    AR: was 1.875 volts/0.4 ms (IQR 1.5 to 3.47, n=38) at implantation which improved to 0.5 volts/0.4 ms (IQR 0.5 to 0.5, n=41) at follow-up.

    VR: was 1.26 volts/0.4ms (IQR 0.75 to 2.93, n=28) at implantation, which improved to 0.5 volts/0.4ms (IQR 0.43 to 0.53, n=31) at follow-up.

    Median estimated battery life (at follow-up: median 21 days)

    AR: 6.8 years (IQR 5.3 to 11.2)

    VR: 10.4 years (IQR 9 to 12.2).

    AR versus DR: (11.9 years, IQR 10.5 to 14.1 versus 5.8 years, IQR 5.1 to 6.9, p=0.001).

    Implant to implant communication (in 29 people with DR system at mean 21 days)

    Median implant to implant throughput achieved: 88% (IQR 80 to 94) for atrial to ventricular and 87% (IQR 71 to 95) for ventricular to atrial.

    The median implant to implant setting level was 5 (IQR 4 to 5) in the AR and 4 (IQR 4 to 5) in the VR.

    Procedure related complications

    Device repositioning: 0

    Acute complications: 0

    Complications (at median 21 days):

    Pericardial effusion (managed conservatively): 4.4% (2/45)

    Device dislodgements or dislocations: 0

    References of additional key studies

    1. Knops RE, Ip JE, Doshi R et al. (2025) One-Year Safety and Performance of a Dual-Chamber Leadless Pacemaker. Circulation. Arrhythmia and Electrophysiology 18: e013619

    2. Reddy VY, Doshi R, Ip JE et al. (2025) Battery longevity of a helix-fixation dual-chamber leadless pacemaker: results from the AVEIR DR i2i Study. Europace 27: euaf074

    3. Nair DG, Lee KW, Badie N, et al. (2025) Atrial helix-fixation leadless pacemaker: real-world single-chamber implant experience. J Interv Card Electrophysiol. doi: 10.1007/s10840-025-02041-8. Epub ahead of print

    4. von Felten E, Breitenstein A, Müller A et al. (2025) First European experience with a leadless atrial pacemaker. Heart Rhythm O2 6: 1062–69

    Table 10 additional studies identified

    Study

    Number of people and follow up

    Direction of conclusions

    Reason study was not included in main evidence summary

    Agarwal S, Patel HP, Asad ZUA et al. (2025) Real-World Outcomes of Leadless Pacemaker Implantation After Transvenous Lead Removal for Infected Cardiac Implantable Electronic Devices in the United States. Am J Cardiol. 2025 253:10-13.

    Ventricular pacing, single chamber

    Retrospective analysis of data from national readmissions database between 2016 and 2021.

    41,058 people had leadless pacemakers and of these 3,244 had the device after transvenous lead removal for Cardiac Implantable Electronic Devices (CIED) infection.

    Follow-up 180 days.

    These findings suggest that while leadless pacemaker implantation following transvenous lead removal is associated with higher procedural complexity, it remains a viable and safe option in this high-risk population and provides important real-world context to guide clinical decision-making.

    More comprehensive studies are included in the summary of evidence.

    Carretta DM, Tomasi L, Tondo C et al. (2025) Leadless Micra pacemakers: estimating long-term longevity. A real word data analysis. Int J Cardiol. 426:133062.

    Ventricular pacing, single chamber

    Prospective multicentre registry.

    n=391 people who had single chamber leadless pacemaker.

    Follow-up median 33.9 months.

    Leadless pacemakers appear to have a median expected longevity ranging from 14 to 17 years. Having a stimulation threshold less than or equal to 1 volt at 0.24 ms seems to be an excellent predictor of increased longevity.

    Projected battery longevity estimates calculated.

    Cha MJ, Park SJ, Cho Y et al. (2025) Safety and Performance of the Micra VR Leadless Pacemaker in a South Korean Cohort: A Comparison to Global Studies. Korean Circ, 55(6):526-537. doi: 10.4070/kcj.2024.0317. Epub 2025 Feb 13.

    Ventricular pacing, single chamber

    Prospective registry

    n=100 people had Micra VR leadless pacemaker implantation at 8 centres.

    Follow-up 12 months.

    In a South Korean cohort, the Micra VR leadless pacemaker was implanted with a high success rate and low major complication rate.

    More comprehensive studies are included in the summary of evidence.

    Chopra M, Hsieh JC, Mueller W et al. (2025) Incidence of pacing-induced cardiomyopathy: left bundle branch area pacing versus leadless pacing. J Interv Card Electrophysiol.

    Ventricular pacing, single chamber

    Comparative case series

    People who had either a leadless pacemaker (n=25) or a permanent pacemaker with a left bundle branch area pacing (n=70, LBBAP) lead for atrioventricular block between 2021 and 2023 were included.

    Follow-up of 14 months.

    In people who are not candidates for cardiac resynchronisation, who need a high burden of ventricular pacing, LBBAP may lead to a lower incidence of pacemaker included cardiomyopathy than right ventricular septal pacing with a leadless pacemaker.

    More comprehensive studies are included in the summary of evidence.

    Fouad M, Abdelsayed K, Tabassum S et al. (2025) Comparative analysis of leadless versus transvenous pacemakers in non-heart failure patients: A Multicenter US retrospective study. J Cardiovasc Electrophysiol. 36(6):1362-1376

    Ventricular pacing, single chamber

    Retrospective propensity-score matched study comparing leadless pacemakers (n=1,158) with transvenous pacemakers (n=1,158) in real-world people without heart failure.

    Follow-up 12 months.

    In the absence of heart failure, leadless pacemaker was associated with fewer rates of mechanical complications and cardiac-related haemodynamic instability. However, late mortality was higher with leadless pacemakers. Hospitalisation rates and reintervention rates were comparable between both groups.

    More comprehensive studies are included in the summary of evidence.

    Gill J, Harb A, Varghese J et al. (2025) Safety of Leadless Pacemaker Insertion in Nonagenarians. J Innov Card Rhythm Manag. 16(5):6272-6277.

    Ventricular pacing, single chamber

    Retrospective analysis of data from National Readmission Database for people who had leadless pacemaker insertion between 2017 and 2020.

    Study demonstrates that leadless pacemaker insertion could be safe in the very elderly population. However, study likely demonstrates survivorship bias, as people in the nonagenarian group had fewer overall comorbidities. Despite adjustment for known comorbidities, there remain confounders that are difficult to account for. Age itself does not seem to be a risk factor for worse outcomes in this population.

    More comprehensive studies are included in the summary of evidence.

    Lago-Quinteiro JR, Reyes-Santias F, Antelo M et al. (2025) Single-chamber pacemakers: with or without leads? Cost-effectiveness and cost-utility analyses. Ann Med. 57(1):2512108.

    Ventricular pacing, single chamber

    Retrospective observational study of 403 people implanted with a conventional (n=244) or leadless pacemaker (n=159).

    Study compared cost-effectiveness and cost-utility.

    Leadless pacemakers have fewer complications than conventional pacemakers and, although the device itself is more expensive, the leadless pacemaker is more cost-effective in around 90% of cases.

    Focused on costs

    Leal MA, Sheldon T, Escalante K et al. (2025) Device longevity of a leadless pacemaker family. Future Cardiol. 21(10):753-75.

    Ventricular pacing, single chamber

    Retrospective modelling and simulation study using real world data (644 people for Micra VR/VR2; 999 people for Micra AV/AV2).

    Modelling of the Micra leadless pacemakers projected meaningful improvements in device longevity and an increase in the number of people served with a single device.

    Projected battery longevity estimates.

    Manzo G, Giannola G, Nigro G et al. (2025) Outcomes of Micra leadless pacemaker implants in centers with and without cardiac surgery. J Cardiovasc Electrophysiol. 36(7):1512-1519

    Ventricular pacing, single chamber

    Retrospective cohort study.

    n=1,899 people who had a Micra pacemaker at 23 centres. People were divided into 2 groups: those implanted in centres with cardiac surgery (n=1,025) and those without (n=874)

    Follow-up 12 months

    The Micra leadless pacemaker can be safely and effectively implanted in centres without cardiac surgery capabilities, broadening access to this technology across diverse clinical settings.

    More comprehensive studies are included in the summary of evidence.

    Mitacchione G, Schiavone M, Gasperetti A et al (2025) Leadless pacemakers in patients with different stages of chronic kidney disease: Real-world data from the updated i-LEAPER registry. Heart Rhythm. 22(2):325-331.

    Ventricular pacing, single chamber

    Registry study

    People were divided into 3 groups according to chronic kidney disease (CKD) stage.

    n=1,748 people enrolled, 33% were in CKD stage G3a/G3b and 9.4% were in CKD stage G4/G5.

    In a real-world setting, people with advanced CKD who had leadless pacemaker implantation were underrepresented. Although all-cause mortality was higher in end-stage CKD, periprocedural complications and leadless pacemaker performance were overall comparable between normal kidney function and different stages of CKD, except for higher values of pacing threshold in people with CKD up to first-month follow-up.

    More comprehensive studies are included in the summary of evidence.

    Nguyen A, Khan MZ, Sattar Y et al. (2025) Procedural complications and inpatient outcomes of leadless pacemaker implantations in rural versus urban hospitals in the United States. Clin Cardiol. 48(3): e70081

    Ventricular pacing, single chamber

    Retrospective analysis

    n=29,005

    (urban hospitals n=28,340, rural hospitals n=665).

    Follow-up: inpatient outcomes only.

    Most leadless pacemaker implantations occurred in urban hospitals in the United States. Important differences in outcomes were described based on urban and rural hospital location.

    More comprehensive studies are included in the summary of evidence.

    Focused only on in-hospital outcomes.

    Palmisano P, Rovaris G, Della Rocca DG et al. (2025) Comparison of 30-day complications between a tine-based and a screw-in helix fixation single-chamber ventricular leadless pacemaker: Results of a propensity score-matched analysis from a multicenter, nationwide registry. Heart Rhythm. 22(8): e431-e437.

    doi: 10.1016/

    j.hrthm.2025.03.1881 Epub 2025 Mar 10.

    Ventricular pacing, single chamber

    Prospective registry

    n=1,141 people who had Aveir VR (n=211) or Micra VR (n=930) implantation.

    Propensity score matched 1:1 (n=189 pairs).

    Follow-up 30 days.

    The risk of acute device-related complications associated with Aveir VR and Micra VR leadless pacemaker implantation was similar. These findings suggest that despite differences in design, fixation mechanism, and implantation technique, these 2 devices appear to have a similar short-term safety profile.

    More comprehensive studies are included in the summary of evidence.

    Short term follow-up.

    Parulkar A, Sheikh W, Has P et al. (2025) Leadless versus single chamber pacemakers: An analysis from the national readmissions database of adverse outcomes. J Cardiovasc Electrophysiol. 36(7):1538-1547

    Ventricular pacing, single chamber

    Retrospective cohort study

    Data from national readmissions database was analysed from January 2016 to December 2019

    Mortality rates were higher in people having leadless pacemakers with a higher incidence of adverse outcomes in patients with dialysis dependence and pulmonary hypertension. Clinical benefits may be offset by increased risk of procedural mortality and adverse outcomes.

    More comprehensive studies are included in the summary of evidence.

    Reed SD, Yang JC, Wallace MJ et al. (2024) Patient preferences for features associated with leadless versus conventional transvenous cardiac pacemakers. Circ Cardiovasc Qual Outcomes. 17(12): e011168.

    Ventricular pacing, single chamber

    Discrete-choice experiment (DCE) survey.

    n=117 people who had a de novo pacemaker indication were included.

    Latent-class analysis revealed strong patient preferences for the type of pacemaker, with a nearly equal split between recent leadless pacemaker technology and conventional transvenous pacemakers. These findings can inform shared decision-making between health care providers and patients.

    Preference based survey.

    Sarsenbayeva A, Baimbetov A, Puodziukynas A et al. (2025) Systematic review and meta-analysis of acute mortality and complication rates following leadless pacemaker placement using national-level data. Medicina (Kaunas). 61(6):974

    Ventricular pacing, single chamber

    Systematic Review and Meta-Analysis

    5 studies were included.

    The reviewed studies suggest that leadless pacemakers offer a promising alternative to transvenous pacemakers, offering a comparable short-term safety profile. Ongoing technological advancements may further enhance their applicability in clinical practice.

    More comprehensive studies are included in the summary of evidence.

    Sears SF, Jordan EW, Hashmath Z et al. (2025) Leadless Pacemakers: The

    "Leading Edge" of quality of life in cardiac electrophysiology. Curr Cardiol Rep. 27(1):77

    Ventricular pacing, single chamber

    Review includes 7 papers that report patient reported outcome measures.

    Evidence indicates that QOL is as good, if not better, than TV-PM. People with L-PM report high levels of acceptance and satisfaction with aesthetic appearance (96%), recovery (91%), and level of physical activity (74%). Leadless pacemakers provide an attractive alternative.

    Review

    Warwas S, Jędrzejczyk-Patej E, Kowalski O et al. (2025) Quality of life in patients with a leadless pacemaker versus transvenous pacemaker. Kardiol Pol. doi: 10.33963/v.phj.106688. Epub ahead of print.

    Ventricular pacing, single chamber

    Prospective non-randomised study (single centre)

    People with leadless pacemakers (n=31) were matched with transvenous pacemaker group (n=31).

    Follow-up 12 months

    Quality of life after device implantation does not differ between leadless and transvenous pacemakers.

    More comprehensive studies are included in the summary of evidence.

    Zhang Z, Wu Z, Luan C et al. (2025) Efficacy and safety of leadless pacemaker implantation in octogenarians: a single-center experience. Front Cardiovasc Med. 12:1571665.

    Ventricular pacing, single chamber

    Case series

    n=154 people had leadless pacemaker implantation.

    (study cohort was stratified into 2 age groups: octogenarians (80 years or above, n=66) and non-octogenarians (younger than 80 years, n=88).

    Median follow-up 12 months.

    Leadless pacemaker implantation appears to be a safe and effective therapeutic option for octogenarians, including those with more combabilities. Therefore, it should be considered a viable alternative to conventional transvenous pacemakers in this aging population.

    More comprehensive studies are included in the summary of evidence.

    Mekary W, Vijayvargiya S, Mouawad C et al. (2025) A Modular Approach for Leadless Pacing. J Cardiovasc Electrophysiol. doi: 10.1111/jce.16740. Epub ahead of print

    Atrial, ventricular or dual-chamber pacing

    Retrospective case series

    n=89 people who had AVEIR leadless pacemaker implantation (37 single-chamber atrial AVEIR, 34 single-chamber ventricular AVEIR, and 18 dual-chamber devices).

    Follow-up median 4.7 months.

    A modular pacing approach for leadless pacing was adopted. This strategy focuses on minimising the amount of hardware in the heart. This reduces complications such as perforation and dislodgment while optimising battery longevity, which is affected by i2i communication.

    Short term follow-up.

    Ip J (2024) Minimizing for Maximum Benefit: An Illustrative Case-Series of Atrial Only Leadless Pacing. https://doi.org/

    10.1111/pace.15138

    Atrial pacing

    Case series

    This first report case-series of atrial LPs describes and discusses the potential use-case scenarios of recently approved helix-fixation atrial LPs. The article highlights important concepts regarding their use, including implantation techniques, programming, battery conservation, and the low rate of progression of AV block in people implanted with AAI(R) pacemakers.

    More comprehensive studies included in table 2.

    Doshi, Rahul N. et al.

    (2025) Chronic wireless communication between dual-chamber leadless pacemaker devices

    Heart Rhythm, Volume 22, Issue 4, 1010 - 1020

    Dual-chamber pacing

    Prospective case series

    n=399 (65% sinus node dysfunction, 35% atrioventricular block)

    Aveir DR i2i Study

    Follow-up 6 months.

    Wireless implant-to-implant communication in the new dual-chamber leadless pacemaker system demonstrated successful transmissions in more than 90% of beats throughout the 6-month evaluation period. Communication success improved significantly over time postimplant for specific subgroups.

    Implant to implant communication outcomes.

    Doshi RN, Ip JE, Defaye P, Reddy VY et al. (2025) Dual-chamber leadless pacemaker implant procedural outcomes: Insights from the AVEIR DR i2i study. Heart Rhythm. 13: S1547-5271 (25) 02176-9.

    Dual-chamber pacing

    Prospective case series

    n=452 people who had de novo implantation of the dual-chamber leadless pacemaker (AVEIR DR).

    Follow-up 30 days

    Implantation of a dual-chamber leadless pacemaker system was successful in 99% of people. Advanced implant experience was accompanied by improvements in procedural outcomes including reduced procedural times (introducer sheath insertion to removal, dual-chamber procedure, ventricular leadless pacemaker and atrial leadless pacemaker procedures, and fluoroscopy) and improved freedom from complications.

    More comprehensive studies are included in the summary of evidence.

    Short term follow-up (30 days).

    Hadadi CA, Lee KW, Lo M, Rashtian M et al. (2025) Commercial implant experience of a helix-fixation dual-chamber leadless pacemaker. J Cardiovasc Electrophysiol. 36(7):1559-1566.

    Dual-chamber pacing

    Multicentre registry study.

    n=175 people with sinus node dysfunction, AV node ablation was implanted with dual-chamber leadless pacemaker.

    Follow-up 30 days post-implantation.

    The initial commercial experience of the helix-fixation, dual-chamber LP system demonstrated safe and efficient implantation with clinically acceptable electrical metrics and minimal acute complications.

    More comprehensive studies are included in the summary of evidence.

    Short term follow-up (30 days), limited to initial commercial rollout without comparator group.

    Neuzil, Petr et al. (2024) Implantation techniques for a helix-fixation dual-chamber leadless pacemaker

    Heart Rhythm, Volume 21, Issue 12, 2552 - 2562

    Dual-chamber pacing

    Review the dual-chamber leadless pacemaker implantation workflow while providing guidance to optimise safe and effective implantation procedures.

    With time and adherence to guidance in this article, novel dual-chamber LP implantation can become streamlined and routine, although the workflow may differ from transvenous implantation with which users are familiar.

    Review on guidance for implantation procedures.

    Rashtian, Mayer Y. et al. (2025) Temperature-based rate response in a leadless pacemaker system

    Heart Rhythm, Volume 22, Issue 6, 1533 - 1540

    Dual-chamber pacing

    The temperature-based sensor in a dual-chamber leadless pacemaker system was shown to be effective at modulating pacing rate in response to increased metabolic demand for right ventricular and atrial devices.

    Studies with more relevant outcomes are included.