A Predictive Model for the Long-Term Electrical Performance of a Leadless Transcatheter Pacemaker

Kiani, Soroosh; Wallace, Kristie; Stromberg, Kurt; Piccini, Jonathan P.; Roberts, Paul R.; El‐Chami, Mikhael F.; Soejima, Kyoko; Garweg, Christophe; Fagan, Dedra H.; Lloyd, Michael S.

doi:10.1016/j.jacep.2020.09.010

Cited by 15 publications

(15 citation statements)

References 12 publications

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“…Our study also confirms the excellent long-term electrical performance of LL devices. This information, together with recent work putting forward a number of predictors of poor LL electrical performance, suggest that LL long-term performance is not only highly efficient but has also a significant degree of predictability [ 20 ]. Lastly, our multivariate analysis on survival did not identify any significant factor associated with all-cause mortality at follow-up, with the exception of age, whose associated comorbidities pose a heavy burden of non-cardiovascular mortality ( Table 3 , Figure 2 and Figure 3 ).…”

Section: Discussionmentioning

confidence: 99%

Is Less Always More? A Prospective Two-Centre Study Addressing Clinical Outcomes in Leadless versus Transvenous Single-Chamber Pacemaker Recipients

Bertelli

Toniolo

Ziacchi

et al. 2022

JCM

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(1) Background: Leadless (LL) stimulation is perceived to lower surgical, vascular, and lead-related complications compared to transvenous (TV) pacemakers, yet controlled studies are lacking and real-life experience is non-conclusive. (2) Aim: To prospectively analyse survival and complication rates in leadless versus transvenous VVIR pacemakers. (3) Methods: Prospective analysis of mortality and complications in 344 consecutive VVIR TV and LL pacemaker recipients between June 2015 and May 2021. Indications for VVIR pacing were “slow” AF, atrio-ventricular block in AF or in sinus rhythm in bedridden cognitively impaired patients. LL indication was based on individualised clinical judgement. (4) Results: 72 patients received LL and 272 TV VVIR pacemakers. LL pacemaker indications included ongoing/expected chronic haemodialysis, superior venous access issues, active lifestyle with low pacing percentage expected, frailty causing high bleeding/infectious risk, previous valvular endocarditis, or device infection requiring extraction. No significant difference in the overall acute and long-term complication rate was observed between LL and TV cohorts, with greater mortality occurring in TV due to selection of older patients. (5) Conclusions: Given the low complication rate and life expectancy in this contemporary VVIR cohort, extending LL indications to all VVIR candidates is unlikely to provide clear-cut benefits. Considering the higher costs of LL technology, careful patient selection is mandatory for LL PMs to become advantageous, i.e., in the presence of vascular access issues, high bleeding/infectious risk, and long life expectancy, rendering lead-related issues and repeated surgery relevant in the long-term perspective.

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Section: Discussionmentioning

confidence: 99%

Is Less Always More? A Prospective Two-Centre Study Addressing Clinical Outcomes in Leadless versus Transvenous Single-Chamber Pacemaker Recipients

Bertelli

Toniolo

Ziacchi

et al. 2022

JCM

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“…Recently, Micra was developed to avoid complications of traditional transvenous pacing systems. 1 , 2 Micra is a single-chamber pacemaker, and there is limited clinical research data about the feasibility and safety of the long-term implantation of Micra 6 ; therefore, older patients with symptomatic bradycardiac atrial fibrillation are good candidates for Micra implantation. Older patients are likely to have many comorbidities, such as atrial fibrillation and dementia.…”

Section: Discussionmentioning

confidence: 99%

End-of-service program compulsory ventricular pacing by the transvenous pacemaker remaining after implantation of a leadless pacemaker

Ogano¹,

Kimura²,

Kawanaka³

et al. 2022

HeartRhythm Case Reports

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Section: Discussionmentioning

confidence: 99%

“…The pacing impedance after fixation has been reported to be associated with the capture threshold during the follow‐up period 10–12 . Kiani et al 10 showed that a pacing impedance of <800 Ω at implantation was related to an elevated capture threshold at 12 months. Other reports have identified a pacing impedance at implantation of >600 Ω or 660 Ω as a predictor of an acceptable threshold 11,12 .…”

Section: Discussionmentioning

confidence: 99%

Fluoroscopic predictors of acceptable capture threshold during the implantation of the micra transcatheter pacing system

Togashi

Sato

Maeda

et al. 2022

Cardiovasc electrophysiol

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Introduction Few predictors of low capture threshold before the deployment of the Micra transcatheter pacing system (Micra TPS) have been determined. We aimed to identify fluoroscopic predictors of an acceptable capture threshold before Micra TPS deployment. Methods Sixty patients were successfully implanted with Micra TPS. Before deployment, gooseneck appearance of the catheter shaft was quantified using the angle between the tangent line of the shaft and the cup during diastole in the right anterior oblique (RAO) view. The direction of the device cup toward the ventricular septum was evaluated using the angle between the cup and the horizontal plane in the left anterior oblique (LAO) view. Results Of the 95 deployments we evaluated, 56 achieved an acceptable capture threshold of ≤2.0 V at 0.24 ms. In this acceptable threshold group, the deflection angle of the gooseneck shaft was significantly larger and the device cup was placed more horizontally with a lower elevation angle compared with those in the high threshold group. A deflection angle of ≥6° and an elevation angle of ≤30° were identified as the predictors of an acceptable capture threshold after deployment. An acceptable capture threshold was achieved in 24/31 (77.4%) patients in whom either angle criterion was satisfied at the first deployment. Conclusions Diastolic gooseneck appearance of the delivery catheter in the RAO view or near‐horizontal direction in the LAO view predicts an acceptable capture threshold after deployment. The shape of the delivery catheter before deployment should be evaluated using multiple fluoroscopic views to ensure successful implantation of Micra TPS.

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A Predictive Model for the Long-Term Electrical Performance of a Leadless Transcatheter Pacemaker

Cited by 15 publications

References 12 publications

Is Less Always More? A Prospective Two-Centre Study Addressing Clinical Outcomes in Leadless versus Transvenous Single-Chamber Pacemaker Recipients

Is Less Always More? A Prospective Two-Centre Study Addressing Clinical Outcomes in Leadless versus Transvenous Single-Chamber Pacemaker Recipients

End-of-service program compulsory ventricular pacing by the transvenous pacemaker remaining after implantation of a leadless pacemaker

Fluoroscopic predictors of acceptable capture threshold during the implantation of the micra transcatheter pacing system

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