Optical coherence tomography-guided versus angiography-guided implantation of everolimus-eluting bioresorbable vascular scaffolds: Comparison of coverage, apposition and clinical outcome. The ALSTER-OCT ABSORB registry

Background: Suboptimal implantation of everolimus-eluting bioresorbable vascular scaffolds (EE-BVS) leading to strut malapposition and lack of neointima coverage has been hypothesized to be linked to late BVS-thrombosis. Optical coherence tomography (OCT) allows assessing subtle differences in BVS-healing. We aimed to link 6-months OCT-data on EE-BVS coverage and malapposition to implantation technique and clinical outcome. Methods: Twenty-nine consecutive EE-BVS-patients were included. EE-BVS-implantation was guided by angiography in the first 17 patients (group 1). Vessel sizing prior to implantation and implantation result was assessed by OCT in the 12 following patients (group 2). EE-BVS-implantation was performed in both groups with adequate lesion preparation, sizing and systematic high-pressure post-dilatation. All patients received 6-months invasive control including OCT-analysis and clinical follow-up for 2 years. Results: The rate of uncovered struts was group 1: 10.8 ± 10.0%; group 2: 10.6 ± 8.2%, p = 0.934. Target lesion failure due to BVS-thrombosis occurred in 2/17 patients at 9 and 18 months (11.8%, group 1), and no patients in group 2 (p = 0.218). Conclusions: Optical coherence tomography analysis at 6-months following EE-BVS-implantation finds almost 90% of struts to be covered. No difference between OCT vs. angiography-guided EE-BVS-implantation was observed. OCT at 6-months was not able to predict late BVS-thrombosis of EE-BVS

Time-to-effect guided pulmonary vein isolation utilizing the third-generation versus second generation cryoballoon: One year clinical success

Background: The second-generation cryoballoon (CB2) provides effective and durable pulmonary vein isolation (PVI) associated with encouraging and reproducible clinical outcome data. The latest- -generation cryoballoon (CB3) incorporates a 40% shorter distal tip, thus allowing for an increased rate of PVI real-time signal recording and facilitating individualized ablation strategies taking the time-to- -effect (TTE) into account. However, whether this characteristic translates into favorable clinical success has not been evaluated yet. Herein was investigated 1-year clinical success after CB3 in comparison to CB2 based-PVI. Methods: One hundred and ten consecutive patients with paroxysmal or short-standing persistent atrial fibrillation (AF) underwent CB2 (n = 55 patients) -or CB3 (n = 55 patients) -based PVI. The freeze-cycle duration was set to TTE + 120 s if TTE could be recorded, otherwise a fixed freeze-cycle duration of 180 s was applied. Results: A total of 217/218 (99%, CB3) and 217/217 (100%, CB2) pulmonary veins (PV) were successfully isolated. The real-time PVI visualization rate was 69.2% (CB3) and 54.8% (CB2; p = 0.0392). The mean freeze-cycle duration was 194 ± 77 s (CB3) and 206 ± 85 s (CB2; p = 0.132), respectively. During a median follow-up of 409 days (interquartile range [IQR] 378–421, CB3) and 432 days (IQR 394–455, CB2) 73.6% (CB3) and 73.1% of patients (CB2) remained in stable sinus rhythm after a single procedure (p = 0.806). Conclusions: A higher rate of real-time electrical PV recordings was seen using the CB3 as compared to CB2. There was no difference in 1-year clinical follow-up

Outcome of a polymer-free drug-coated coronary stent in bifurcation lesions-Pilot registry with serial OCT imaging

Background Polymer-free and carrier-free drug-coated stents (DCS) represent a novel therapeutic option for the treatment of coronary artery disease. The objective of this pilot registry is to evaluate the safety and efficacy of DCS implantation in bifurcation lesions. Methods Overall, 23 consecutive patients with 24 lesions received a Biolimus A9-coated DCS for coronary bifurcation lesions. Patients were examined with quantitative coronary angiography (QCA) and optical coherence tomography (OCT) at 3-6 months of follow-up. Results A total of 23 patients with 24 bifurcation lesions were included in this study. Nine (33.3%) lesions of eight patients revealed angiographical target lesion failure due to in-stent restenosis (ISR). In total, 19 patients with 20 bifurcation lesions were suitable for OCT analysis. A total of 2936 struts were analyzed and 14 struts (0.47%) were classified as malapposed. The mean luminal area (mm(2)) was not different in lesions with ISR vs. lesions with no ISR (5.07 +/- 2.0 vs. 5.73 +/- 1.34, p = 0.39) at follow-up. Lesions with ISR showed higher mean neointimal burden (27.11 +/- 10.59 vs. 13.93 +/- 9.16%, respectively; p = 0.009). All of the patients who presented with significant ISR required percutaneous re-intervention. Conclusions We observed a high rate of DCS ISR in bifurcation lesions, possibly related to increased inflammation and neoatherosclerosis. The small size of the study warrants careful interpretation of our results. Larger trials are necessary to expand knowledge of these findings

Safety and Efficacy of Cryoballoon Based Pulmonary Vein Isolation in Patients with Atrial Fibrillation and a History of Cancer

Introduction: A growing body of evidence suggests a strong association between atrial fibrillation (AF) and cancer. A relevant number of patients with a present or former malignant disease with highly symptomatic drug-refractory AF are in need of interventional therapy. Data on the safety and efficacy of catheter ablation in these patients are sparse. The present study aims to analyze the safety and efficacy of cryoballoon-based pulmonary vein isolation (CB-PVI) for symptomatic AF in patients with past or present cancer disease. Methods and Results: Consecutive patients undergoing CB-PVI for symptomatic AF at University Hospital Lübeck, Germany between July 2015 and January 2019 were included in this study. Propensity-score based matching was performed to identify comparable patients with and without cancer disease and further analyze clinical characteristics, periprocedural complications and arrhythmia-free survival. A total of 70 patients with a history of cancer undergoing CB-PVI were matched to 70 patients without a history of cancer. The frequency of complications was similar between patients with and without a history of cancer (p = 0.11), with four phrenic nerve palsies occurring in patients with a history of cancer (5.6% of the cohort) vs. one phrenic nerve palsy in patients without cancer (p = 0.36). Arrhythmia free survival after 12 months did not differ significantly in patients with and without a history of cancer (67.1 ± 5.8% vs. 77.8% ± 5.1%, p = 0.16). Conclusion: This study indicates that CB-PVI for symptomatic AF is equally safe and effective in patients with and without a history of cancer and cancer treatment

Does Size Matter? Cryoballoon-Based Pulmonary Vein Isolation Using a Novel 25-mm Circular Mapping Catheter

Real-time recording of pulmonary vein isolation (PVI) using a circular mapping catheter has become a key aspect of cryoballoon (CB) ablation. The aim of this study was to investigate the procedural safety, efficacy and rate of real-time pulmonary vein (PV) recording using a novel circular mapping catheter with a 25-mm loop size for CB-based PVI.Methods and Results:A total of 40 patients with symptomatic atrial fibrillation (AF) underwent PVI using a second-generation CB and a novel 25-mm circular mapping catheter. A total of 159 PV were identified and successfully isolated. Real-time PV recording was achieved in 80% of the PV. In 3 right inferior PV the circular mapping catheter had to be exchanged for a stiff guidewire due to insufficient mechanical support. Therefore, acute PVI using exclusively the circular mapping catheter was achieved in 156/159 PV (98%). Mean procedure and fluoroscopy times were 66±21 min and 15±6 min, respectively. Transient phrenic nerve palsy occurred in 1 patient as the only procedural complication

Is less more? Impact of different ablation protocols on periprocedural complications in second-generation cryoballoon based pulmonary vein isolation

Second-generation cryoballoon (CB2) based pulmonary vein isolation (PVI) has emerged as an effective treatment option for symptomatic atrial fibrillation (AF). The current study sought to assess the impact of different ablation protocols on the incidence and characteristics of procedural complications in a large patient cohort