Leadless pacing using the transcatheter pacing system (Micra TPS) in the real world: initial Swiss experience from the Romandie region

Valiton, Valérian; Graf, Denis; Pruvot, Étienne; Carroz, Patrice; Fromer, Martin; Bisch, Laurence; Tran, Vân Nam; Cook, Stéphane; Scharf, Christoph; Burri, Haran

doi:10.1093/europace/euy195

Cited by 36 publications

(38 citation statements)

References 11 publications

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“…The pacing thresholds observed in this study were similar to previously published results 3,10,12 . The percentage of patients with a high IPT (>1 V/0.24 ms) was similar to that observed in the largest Micra transcatheter registry 10 .…”

Section: Discussionsupporting

confidence: 90%

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Very high pacing thresholds during long‐term follow‐up predicted by a combination of implant pacing threshold and impedance in leadless transcatheter pacemakers

Tolosana

Guasch

Antonio

et al. 2020

Cardiovasc electrophysiol

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Background Micra transcatheter pacemaker system (TPS) usually achieves low implant pacing threshold (IPT). However, IPT may increase in some patients during follow‐up. Aim To apply implant parameters in predicting long‐term occurrence of very high pacing threshold (VHPT) in patients with Micra‐TPS. Methods A cohort of 110 consecutive patients implanted with a Micra‐TPS from 2014 to 2018 was evaluated at discharge and at 1, 12, 24, 36, and 48 months follow‐up. VHPT was defined as greater than 2 V/0.24 ms. VHPT predictors were identified. Results Micra‐TPS was implanted successfully in 108 patients (98.2%). During a mean follow‐up of 24 ± 16 months, 18 patients (16.7%) died of causes nonpacemaker‐related, and 4 (3.8%) developed VHPT. Patients with VHPT had higher IPT and lower implant impedance than patients with non‐VHPT: 1 ± 0.31 vs 0.55 ± 0.29 V/0.24 ms (P = .003) and 580 ± 59 vs 837 ± 232 Ω (P = .03), respectively. IPT and impedance had excellent discriminative power to predict VHPT (area under the curve: 0.85 ± 0.07 and 0.91 ± 0.05, respectively). Negative predictive value (NPV) of IPT ≤ 0.5 V/0.24 ms was 100%; positive predictive value (PPV) was 8% throughout follow‐up. Implant impedance ≤ 600 Ω had NPV of 99% throughout follow‐up, whereas PPV varied: 16%, 21%, 16%, and 28% at 1, 12, 24, and 36 months, respectively. Sequential combination of IPT greater than 0.5 V/0.24 ms and impedance ≤ 600 Ω improved PPV to 25%, 35%, 27%, and 44%, respectively, whereas NPV remained 99% throughout follow‐up. Conclusion Despite favorable long‐term electrical performance of Micra‐TPS, a small percent of patients developed VHPT during follow‐up. A sequential combination of IPT and impedance could allow the implanter to identify patients who will develop VHPT during long‐term follow‐up.

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Section: Discussionsupporting

confidence: 90%

“…Since the implantation procedures were all performed in a specialized center by two experienced operators, the reproducibility of the results in terms of complications and Micra‐TPS delivery attempts should not be extended to other centers with less experienced operators 12 …”

Section: Discussionmentioning

confidence: 99%

Very high pacing thresholds during long‐term follow‐up predicted by a combination of implant pacing threshold and impedance in leadless transcatheter pacemakers

Tolosana

Guasch

Antonio

et al. 2020

Cardiovasc electrophysiol

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“…In this case series, the mean capture threshold was 0.53 ± 0.27 V at 0.24 ms and mean R-wave was 13 ± 5.8 mV with no cases of acute dislodgement [13]. A study of 92 patients with leadless pacemakers (Micra™) at a Swiss single center found median capture thresholds at implant were 0.38 V at 0.24 ms (range 0.13-2.88 V at 0.24 ms), which remained stable throughout 1 year of follow-up [14]. In a case series of five leadless pacemaker patients (Micra™), all of the devices were successfully implanted [13].…”

Section: Implantation Techniquesmentioning

confidence: 99%

“…At 30 days after implantation, 13 major complications were reported in 12 patients (1.51% complication rate, 95% CI, 0.78-2.62%) [19]. In a Swiss retrospective observational study of 92 Micra™ patients, the serious adverse event rate was 6.5% (n = 6), resulting in extended hospitalization for five patients and one death; three other adverse events occurred over the one-year follow-up (3.3% of patients, n = 3), resulting in revision to a conventional transvenous pacemaker in two patients and extraction of the pacemaker in the third because of ventricular tachycardia [14].…”

Section: Micra™ Clinical Studiesmentioning

confidence: 99%

Leadless Pacemakers

Magnusson¹,

Pergolizzi²,

LeQuang³

2019

Cardiac Pacing and Monitoring - New Methods, Modern Devices

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Leadless or transcatheter pacemakers have recently been introduced to market with important benefits and some limitations. Implanted entirely within the right ventricle, these devices eliminate the need for transvenous pacing leads and pacemaker pockets and thus reduce the risk of infections and lead-related problems. Currently, they offer only VVI/R pacing and they cannot provide atrial sensing, antitachycardia pacing, or AV synchrony. They offer a number of features (such as rate response) and electrogram storage, albeit more limited than in a transvenous system. Real-world clinical data are needed to better comment on projected battery life, which manufacturers suggest will be at least equivalent to transvenous devices. Extracting an implanted leadless pacemaker remains a challenge, although proprietary snare and removal systems are available. However, a leadless pacemaker at end of service may be programmed to OOO and left in place; a revised device may be implanted adjacent. These innovative new devices may have important uses in special populations. Initial data on implant success and adverse events are favorable. Currently, there are two leadless pacemakers available: the Micra™ device by Medtronic and the Nanostim™ device by Abbott (formerly St. Jude Medical).

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“…), as compared with the seven different cardiologists in Valiton's paper. 3 Conflict of interest: C.G., R.W. received research funding from Biotronik, Boston Scientific and Medtronic, speakers and consultancy fees from Biotronik, Boston Scientific, Medtronic and Abbot.…”

mentioning

confidence: 99%