Key result
The SonRtip atrial lead demonstrated an unexpectedly high long-term malfunction rate of 4.9% compared to 0.57% for conventional atrial leads over a median follow-up of 2.34 years.
Why the study?
Long-term performance of the SonRtip atrial lead embedded with a sensor measuring peak endocardial acceleration had not been reported.
Does the SonRtip atrial lead have a higher long-term malfunction rate compared to conventional bipolar atrial leads in patients receiving CRT?
Observational (n=669)
Yes
Does the SonRtip atrial lead have a higher long-term malfunction rate compared to conventional bipolar atrial leads in patients receiving CRT?
The SonRtip atrial lead is associated with a significantly higher long-term malfunction and replacement rate compared to conventional atrial leads in patients receiving CRT.
OBJECTIVES: To evaluate the long-term performance of the SonRtip atrial lead. BACKGROUND: To optimize atrioventricular and interventricular timing and thereby potentially improving cardiac resynchronization therapy (CRT) responder rates, a lead integrated technology and a cardioverter/defibrillator-based algorithm measuring peak endocardial acceleration have been introduced. Long-term performance of the atrial lead (SonRtip PS55D, Sorin/MicroPort CRM, Italy) embedded with such a sensor has not been reported so far. METHODS: Between 2012 and 2018, 143 patients underwent implantation of the SonRtip atrial lead in four Austrian medical centers. Conventional bipolar atrial leads implanted during the same period in 526 patients receiving CRT were used as control cohort. RESULTS: Among 669 patients included in the study, 10 (1.5%) showed increased atrial pacing thresholds and/or decreased atrial sensing amplitudes and/or sudden increase in atrial lead impedance (above 3000 Ω) after an uneventful early postoperative period. Seven (70%) of the malfunctioning leads were SonRtip leads (p <0.001). Lead replacement was needed in 4.2% of SonRtip leads (six out of 143) and in 0.38% of all other conventional atrial leads (two out of 526) (p <0.001). Because of unaltered atrial sensing properties, a wait and see strategy was chosen in two patients-one of them with a SonRtip lead. The implanted atrial lead in the latter person experienced a sudden increase in pacing threshold (4V/0.35ms). CONCLUSIONS: While short-term safety and stable technical performance of the SonRtip atrial lead could be confirmed, our study found an unexpectedly high malfunction rate over a longer follow-up period.
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Senoner et al. (2019) conducted an observational in Cardiac resynchronization therapy (CRT) indication (n=669). SonRtip atrial lead vs. Conventional bipolar atrial leads was evaluated on Atrial lead malfunction (increased pacing thresholds, decreased sensing amplitudes, or sudden increase in impedance above 3000 Ω) (p=<0.001). The SonRtip atrial lead demonstrated an unexpectedly high long-term malfunction rate of 4.9% compared to 0.57% for conventional atrial leads over a median follow-up of 2.34 years.
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