Background:The implantation procedure of left ventricular (LV) leads and the management of cardiac resynchronization therapy (CRT) patients can be challenging. The IS-4 standard for CRT offers additional pacing vectors compared to bipolar leads (IS-1). IS-4 leads improve procedural outcome and may also result in lower adverse events during follow-up (FU) and improve clinical outcome in CRT patients. Further long-term FU data comparing the two lead designs are necessary. Methods:In this retrospective, single-center study we included adult patients implanted with a CRT-Defibrillator (CRT-D) or CRT-Pacemaker (CRT-P) with a quadripolar (IS-4 group) or bipolar (IS-1 group) LV lead and with available ≥3 years clinical FU. The combined primary endpoint was a combination of predefined, lead-related adverse events. Secondary endpoints were all single components of the primary endpoint.Results: Overall, 133 patients (IS-4 n = 66; IS-1 n = 67) with a mean FU of 4.03 ± 1.93 years were included. Lead-related adverse events were less frequent in patients with an IS-4 lead than with an IS-1 lead (n = 8, 12.1% vs. n = 23, 34.3%; p = .002).The secondary outcomes showed a lower rate of LV lead deactivation/explantation and LV lead dislodgement/dysfunction (4.5% vs. 22.4%; p = .003; 4.5% vs. 17.9%; p = .015, respectively) in the IS-4 patient group. Less patients suffered from unresolved phrenic nerve stimulation with an IS-4 lead (3.0% vs. 13.4%; p = .029). LV lead-related re-interventions were fewer in case of an IS-4 lead (6.1% vs. 17.9%; p = .036). Conclusion:In this retrospective analysis, the IS-4 LV lead is associated with lower lead-related complication rates than the IS-1 lead at long-term FU.
Background A novel multipolar pulsed-field ablation (PFA) catheter has recently been introduced for pulmonary vein isolation (PVI). Pre-market data showed high rates for PVI-durability during mandatory remapping studies. Objective: To present post-market data in patients with recurrent arrhythmias. Methods Consecutive patients undergoing a redo procedure after an index PFA PVI using a bipolar-biphasic PFA system were included. 3-D electro-anatomical maps (3D-EAM) on redo procedure were compared to the 3D-EAM acquired after ablation during the index procedure. PVI durability was assessed on a per-vein and per-patient level and the sites of reconnections were identified. Furthermore, lesion extent around veins with durable isolation was compared to study lesion regression. Results Of 341 patients treated with a PFA PVI, 29 (8.5%) underwent a left atrial redo ablation due to arrhythmia recurrence. At the end of the index procedure, 110/112 veins (98%, four common ostia) were isolated. On redo procedures performed a median of 6 months after the first ablation, 3D-EAM identified 69/110 (63%) PVs with durable isolation. In 6 (21%) patients, all PVs were durably isolated. Reconnections were more often found on the right-sided veins and on the anterior aspects of the upper veins. Only minor lesion regression was observed between the index and redo procedure (a median of 3 mm (0 – 9.5) on the posterior wall). Conclusion In patients with arrhythmia recurrence after PFA PVI using a first-generation PFA device, durable isolation was observed in 63% of the veins and 21% of the patients showed durable isolation of all previously isolated veins. Graphical abstract
BACKGROUND The implantation of left ventricular (LV) leads for cardiac resynchronization therapy (CRT) and the management of lead-related complications can be challenging. The introduction of the quadripolar IS-4 LV lead may have facilitated the implantation procedure and may have reduced lead-related complications. Data of long-term follow-up (FU) comparing the IS-4 lead with the IS-1 LV lead are rare and conflicting. PURPOSE Comparison of lead-related complications and all-cause mortality between CRT patients who received an IS-4 or an IS-1 LV lead in the long-term FU. METHODS Adults with an indication for a CRT-Defibrillator or CRT-Pacemaker, a successful endovascular IS-4 or IS-1 LV lead implantation, and a minimal FU of three years were included in this retrospective study. The combined primary endpoint was freedom from lead-related complications defined as (i) occurrence of persisting high pacing threshold (>2.75V/0.4ms), (ii) unresolved phrenic nerve stimulation, (iii) LV lead dislodgement/disruption, (iv) the necessity of re-interventions affecting the LV lead, and (v) LV lead deactivation/explantation. Secondary endpoints were all singular complications and all-cause mortality. RESULTS Eligible for the study were 133 patients (IS-4 n = 66; IS-1 n = 67) with a mean FU of 4.03 ± 1.93 years. Baseline characteristics of both patient groups did not differ significantly. Freedom from lead-related complications was higher in patients with an IS-4 lead as compared to an IS-1 lead (Figure 1; 87.9% vs. 65.7%; p = 0.002). The secondary outcomes showed a higher rate of LV lead dislodgement/disruption (4.5% vs. 17.9%; p = 0.015) in the IS-1 patient group and more patients suffered from unresolved phrenic nerve stimulation with an IS-1 lead (3.0% vs. 13.4%; p = 0.029). LV lead deactivation/explantation during FU and LV lead-related re-interventions were fewer in case of an IS-4 lead (4.5% vs 22.4%; p = 0.003; 6.1% vs. 17.9%; p = 0.036, respectively). The rate of persisting high pacing thresholds and all-cause mortality did not differ (4.5% vs. 9.0%; p = 0.492; 22.7% vs 25.4%; p = 0.721, respectively). CONCLUSION The quadripolar IS-4 LV lead showed in this retrospective study a better long-term performance than the bipolar IS-1 lead. Abstract Figure 1
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