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

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.

Impact of cryoballoon applications on lesion gaps detected by magnetic resonance after pulmonary vein isolation.

INTRODUCTION: Ablation with second-generation cryoballoon technology evolves as an effective and safe alternative to radiofrequency for atrial fibrillation ablation procedures. Nevertheless, the optimal freezing strategy remains unknown. Our objective was to identify the procedural cryoablation parameters predicting successful peri-pulmonary vein (PV) lesions by directly analyzing Postablation gaps in late-gadolinium-enhanced cardiac magnetic resonance (LGE-CMR). METHODS AND RESULTS: Forty-nine consecutive patients (196 PVs) undergoing ablation with second-generation cryoballoon at our center were included. The number and duration of cryoballoon application to achieve PV isolation were left to operator discretion. Gap number and length were quantified in all patients with a LGE-CMR performed 3 months postablation. Application time (420 ± 217 seconds), number of applications (2.1 ± 1.2), application time after electrical isolation (311 ± 194 seconds) and minimum temperature (-45.8 ± 6.5°C) were similar in the 4 PVs. Gaps were observed in 148 PVs (76%), averaging 1.3 ± 1 gaps per vein. Gaps were longer and more frequent in the right PVs (91% vs 59% in left PVs, P < .001). Neither the number, total duration of applications, nor postisolation application time predicted relative length or number of gaps. CONCLUSIONS: After successful PV isolation was achieved in patients undergoing cryoablation, increasing the number of applications, the total application time or application time postisolation did not result in a reduction in the number or the relative length of gaps.

Failure-free survival of the Riata implantable cardioverter-defibrillator lead after a very long-term follow-up.

AIMS: Riata® implantable cardioverter-defibrillator (ICD) leads from St. Jude Medical are prone to malfunction. This study aimed to describe the rate of this lead's malfunction in a very long-term follow-up. METHODS: This single-centre observational study included 50 patients who received a Riata 7Fr dual-coil lead between 2003 and 2008. Follow-up was conducted both in person and remotely, and analysed at 8-month intervals. We evaluated the rates of cable externalization (CE), electrical failure (EF), and the interaction of these two complications. Structural lead failure was defined as radiographic CE. Oversensing of non-cardiac signal or sudden changes in impedance, sensing, or pacing thresholds constituted EF. RESULTS: During a mean follow-up of 10.2 ±â€¯2.9 years, 16 patients (32%) died. We observed lead malfunction in 13 patients (26%): three (23%) due to CE, six (46%) to EF and four (31%) to both complications. Of the malfunctioning leads, 77% failed after seven years of follow-up. The incidence rate (IR) of overall malfunction per 100 patients per year was 0.9 during the first seven years post-implantation, increased to 7.0 after the 7th year and more than doubled (to 16.7) after 10 years. Beyond seven years post-implantation, IR per 100 patient-years increased in both EF and CE (from 0.6 to 5.6 vs. 0.3 to 4.2, respectively). Presence of CE was associated with a 4-fold increase in the proportion of EF. CONCLUSION: The incidence of Riata ICD lead malfunction, both for EF and CE, increased dramatically after seven years and then more than doubled after 10 years post-implantation.

Undetected displacement of a subcutaneous implantable cardioverter-defibrillator lead. importance of performing a chest X-ray during the first weeks post-implant: a case report.

BACKGROUND: In recent years, subcutaneous implantable cardioverter-defibrillator (S-ICD) implants have progressively increased and have been shown to be safe and highly successful, affording low reintervention rates regardless of the technique used. CASE SUMMARY: We present a case of S-ICD implantation in a patient diagnosed with idiopathic ventricular fibrillation. In the first follow-up consultation the patient showed appropriate detection parameters in the three configurations. However, chest X-ray revealed lead displacement with a tip migration from the manubrium area of the sternum to the xiphoid process. DISCUSSION: This case highlights the importance of performing at least one chest X-ray during the first weeks after S-ICD implantation, allowing the detection of a problem such as lead displacement, which can lead to undersensing of ventricular arrhythmias or S-ICD oversensing.

Management of anticoagulation in patients undergoing leadless pacemaker implantation.

BACKGROUND: The Micra transcatheter pacing system (Micra TPS) is often implanted in patients with atrial fibrillation and thus with increased thromboembolic risk. It is unknown whether the use of anticoagulants, associated with the use of a large venous introducer, implies an increased risk of bleeding in this group of patients. OBJECTIVE: The purpose of this study was to assess the incidence of bleeding and thromboembolic complications after Micra TPS implantation with and without therapeutic anticoagulation. METHODS: This single-center observational study included 107 consecutive patients receiving the Micra TPS from 2014 to 2018. At procedure completion, a figure-of-eight suture was placed at the femoral puncture site after sheath withdrawal and was maintained for 24 hours. In patients receiving enoxaparin or new oral anticoagulants, treatment was discontinued 12 or 24 hours before the procedure, respectively, and was reinitiated 4-6 hours postprocedure. In those receiving vitamin K antagonists (VKAs), dosing was not discontinued and the procedure was performed if the international normalized ratio was less than 3. RESULTS: Sixty-four patients (60%) did not receive anticoagulants. Of the 43 (40%) who did, 29 (67%) received VKAs, 8 (19%) received new oral anticoagulants, and 6 (14%) received enoxaparin. Two patients presented hemorrhagic or thromboembolic complications during short-term follow-up: 1 woman receiving VKAs presented hemorrhagic pericardial effusion without tamponade and 1 woman not receiving anticoagulants presented thrombosis of the ipsilateral saphenous vein. CONCLUSION: Bleeding and thromboembolic complications after receiving Micra TPSs are infrequent. The use of anticoagulant therapy, regardless of the type, does not increase the complications associated with the procedure.