A178 Multi-center registry experience with the new radial catheter system zebra

Nusinersen, an antisense oligonucleotide enhancing the production of the survival motor neuron protein, is approved for the treatment of spinal muscular atrophy (SMA) but requires repetitive lumbar punctures. Application via a subcutaneous port connected to a permanent intrathecal catheter has been proposed as an alternative for patients with severe scoliosis, spinal fusion, or comorbidities, rendering serial interlaminar punctures complicated and risky. Since experience with this technique is sparse and follow-up data are lacking, we assessed feasibility, safety, and tolerability of this approach in eight patients with SMA II/SMA III receiving Nusinersen in a multicenter study. Median age at port implantation was 21 years (range: 10-30 years), and median follow-up time thereafter was 19 months (range: 7-24 months). Leakage of the port catheter occurred in two patients, promptly resolving after resuturing. No further complications such as infection, dislocation, kinking, or obstruction of the port were noted in any of the patients. These findings suggest that application via an intrathecal port and catheter system represents a safe and feasible option for Nusinersen treatment in subjects with SMA. However, to detect rare adverse events longer term follow-up in a larger study cohort is warranted.

We aimed to evaluate the efficacy and safety of antegrade fenestration and reentry (AFR) for chronic total occlusion (CTO) recanalization in a multicenter registry. Adoption of antegrade dissection/reentry (ADR) for CTO recanalization has been limited, and novel ADR techniques are needed. AFR involves the balloon-induced creation of multiple fenestrations between the false and true lumen. A targeted true lumen reentry is subsequently achieved with a low tip-load polymer-jacketed guidewire. Following the initial description and dissemination of AFR, patients undergoing AFR-based CTO recanalization at nine centers were included in the present registry. Study endpoints were AFR success, procedural success, and target-lesion failure (TLF) on follow-up. We included 41 patients. Mean J-CTO score was 2.5 ± 1.4. In 80.5% of cases, AFR was performed after failed antegrade wire escalation. Another ADR technique was used before AFR in one-third of cases. AFR achieved distal true lumen reentry in n = 27/41 (65.9%) cases. In n = 14/41 (34.1%) cases with AFR failure, use of alternative techniques led to successful CTO recanalization in eight additional patients. The overall technical and procedural success rates were 85.4% and 82.9%, respectively. No AFR-related complications were observed. One-year TLF rate was 8.3% overall, with no differences between successful and failed AFR. We report on AFR feasibility in a multicenter registry of patients undergoing CTO recanalization. We observed a moderate success rate, coupled with the absence of complications. Moreover, even a failed AFR attempt did not preclude the use of alternative techniques to achieve recanalization. Further studies should confirm and extend our findings.

To assess the long-term outcomes of patients treated with sirolimus-eluting Stentys stent in a real-life setting. Few data regarding the safety and effectiveness of self-apposing sirolimus-eluting Stentys stent are available. 278 patients (30% stable coronary artery disease, 70% acute coronary syndromes, and 54% on unprotected left main) treated with sirolimus eluting Stentys stent were retrospectively included in the self-aPposing, bAlloon-delivered, siRolimus-eluting stent for the Treatment of the coronary Artery disease multicenter registry. Major adverse cardiovascular events (MACE, a composite of cardiac death, myocardial infarction, target lesion revascularization, stent thrombosis) were the primary end-point, single components of MACE were the secondary ones. After 13 months (interquartile range 5-32), MACE was 14%. Stent thrombosis occurred in 3.9% of the patients (2.5% definite stent thrombosis and 1.4% probable stent thrombosis), 66% of them presenting with ST-segment elevation myocardial infarction (STEMI) at admission. Cardiovascular death, target lesion revascularization and myocardial infarction was 4.7%, 8.3%, and 7.2%, respectively. At multivariate analysis, risk of MACE was increased by diabetes (hazard ratios 4.76; P = 0.002) but was not affected by the indication leading to sirolimus-eluting Stentys stent implantation (marked vessel tapering vs. coronary ecstasies, hazard ratios 0.74, P = 0.71). Sirolimus-eluting Stentys stent may represent a potential solution for specific coronary anatomies such as bifurcation, ectasic, or tapered vessels. Risk of stent thrombosis appears related to clinical presentation with STEMI and to anatomic features, stressing the importance of the use of intracoronary imaging for self-expandable stents implantation.

The flow-diverter devices (FDDs) safety and effectiveness have been demonstrated by large series and meta-analyses. Due to the high occlusion rates and the acceptable morbidity rates of FDDs, the indications for their use are continuously expanding. We presented our Italian multicentric experience using the second generation of DERIVO® Embolization Device (DED®; Acandis, Pforzheim, Germany) to cure cerebral aneurysms, evaluating both middle and long-term safety and efficacy of this device. Between July 2016 and September 2017 we collected 109 consecutive aneurysms in 108 patients treated using DED® during 109 endovascular procedures in 34 Italian centers (100/109 aneurysms were unruptured, 9/109 were ruptured). The collected data included patient demographics, aneurysm location and characteristics, baseline angiography, adverse event and serious adverse event information, morbidity and mortality rates, and pre- and post-treatment modified Rankin Scale scores. Midterm and long-term clinical, angiographic and cross-sectional CT/MR follow-up were recorded and collected until December 2018. In 2/109 cases, DED® placement was classified as technical failures. The overall mortality and morbidity rates were respectively 6.5% and 5.5%. Overall DERIVO® related mortality and morbidity rates were respectively 0% and 4.6% (5 out of 108 patients). Midterm neuroimaging follow-up showed the complete or nearly complete occlusion of the aneurysm in 90% cases, which became 93% at long-term follow-up. Aneurysmal sac shrinking was observed in 65% of assessable aneurysms. Our multicentric experience using DED® for endovascular treatment of unruptured and ruptured aneurysms showed a high safety and efficacy profile, substantially equivalent or better compared to the other FDDs.

Immediate results and late outcomes after stent implantation in saphenous vein graft lesions: The multicenter U.S. Palmaz-Schatz stent experience

To assess the feasibility and safety of the 7 French (Fr) Glidesheath Slender for complex transradial (TR) percutaneous coronary interventions (PCI). The TR approach is increasingly used worldwide for coronary and peripheral vascular interventions. However, the small size of the radial artery remains an important limitation for the use of large-bore guiding catheters (>6 Fr), restricting thereby the treatment of highly complex lesions through the TR approach. The 7 Fr Glidesheath slender (Terumo, Tokyo, Japan) is a new dedicated radial sheath with a thinner wall and hydrophilic coating. It combines an inner diameter compatible with any 7 Fr guiding catheter and an outer diameter smaller than current 7 Fr sheaths. Prospective multicenter registry of complex TR PCI cases using the 7 Fr Glidesheath Slender to determine the procedural success, rates of vascular complications, radial spasm, and radial artery occlusion (RAO). A total of 60 patients were included. Procedural success was 97% with only one access-site crossover. The use of a 7 Fr guiding catheter was indicated for the treatment of highly complex coronary lesions including distal left main (LM) disease (n = 20), complex non-LM bifurcation lesions (n = 16), chronic total occlusion (n = 15), and severely calcified vessels requiring rotational atherectomy (n = 10). There were three vascular access-site complications (4.7%) including two moderate (type II) local hematoma and one uncomplicated guiding catheter-induced brachial artery dissection. None of the patients experienced major bleeding. The occurrence of radial spasm was reported in seven patients (11%). Doppler ultrasound imaging of the radial artery at 1 month was available in 62 of 64 radial access with three cases of RAO (4.8%). Use of the 7 Fr Glidesheath slender for complex coronary interventions is feasible and associated with a high rate of procedural success and a low rate of vascular complications. These favorable results need be confirmed in larger multicenter studies. © 2016 Wiley Periodicals, Inc.

To examine the clinical experience and practical use of the PASCAL transcatheter valve repair system (Edwards Lifesciences, Irvine, CA, USA) and to report some of the first clinical results. A total of 18 consecutive patients with severe, symptomatic mitral regurgitation (MR) were included in this German multicentre registry. All patients underwent clinical, echocardiographic, and laboratory assessment prior to the PASCAL procedure and before hospital discharge. MR was classified as functional in 6 patients, degenerative in 2, and combined in 10. All except one received a single PASCAL implant. The preprocedural severe MR present in all patients was reduced: grade 0 in 4 (22.2%), grade I in 11 (61.1%), grade II in 3 (16.7%). The v-wave was significantly reduced from 31.7 ± 9.5 to 18 ± 7.7mmHg (p < 0.001). Independent leaflet capture, performed in 4 (22.2%) of the patients, wide clasps, and the 10-mm central spacer are features of the PASCAL device to optimize mitral leaflet repair. There were no periprocedural complications. PASCAL is a safe and effective mitral valve repair device for the treatment of severe MR. Device-specific features allow valve repair tailored to the individual anatomy of the underlying mitral pathology in each patient.

Whether cooling catheters should be preferred for atrial fibrillation (AF) ablation is not yet clear. From April 2005 to October 2006, 991 (74% men) consecutive patients who underwent AF ablation were prospectively enrolled in 10 Italian centers. For the present subanalysis, patients were ranked in the two study groups on the basis of the catheter system chosen: 8-mm tip was used in 86 patients (9% conventional group) and open-irrigated tip in 905 patients (91% cooled group). The registry clinical data of both groups showed marked heterogeneity due to the fact that the higher number of patients of the cooled group had longer AF history (4.9+/-4.1 versus 1.2+/-1.8 years; P=0.0001), permanent/persistent AF (41.2 versus 27.9%; P=0.01), and larger left atrium (LA) size (44.1+/-6.2 versus 33.4+/-10.5 mm; P<or=0.00001). Moreover, they underwent a longer procedure (207.2+/-70.8 versus 85.2+/-58 min; P=0.00001), with longer fluoroscopy time (36.5+/-20.1 versus 15.6+/-12 min; P<or=0.0000), and LA roof ablation lines were more frequently added (29.6 versus 3.5%; P<0.0001). Data were confirmed in the multivariate analysis, in which a longer procedure [odds ratio (OR) 1.018; 95% CI 1.009-1.027; P=0.0001], added linear lesions (OR 16.847; 95% CI 4.288-66.190; P=0.0001), and a longer AF history (OR 1.311; 95% CI 1.063-1.616; P=0.01) continued to characterize the cooled group. Even though the lack of homogeneity of the groups could not render any reliable comparison about safety, we report that the rate of cumulative complications (4.7 versus 3.8%; P=NS), cerebral thromboembolism (0 versus 0.4%; P=NS), pulmonary vein (PV) stenosis (0 versus 0.5%; P=NS), pericardial effusions or tamponade (1.2 versus 1.5%; P=NS), and groin complications (4.7 versus 2.0%, P=NS) was low and similar in both the groups. In the present subanalysis, both the systems showed a similar safety procedural profile, though the lack of homogeneity observed in the two study groups could render any straight conclusion as mere speculation. The longer availability and the consequent higher use of open-irrigated catheters technology for LA ablation in Europe could explain the large preference given to the latter system in the present registry.