TCT-825 Simplicity Denervation System for Pulmonary Artery Denervation in Patients with Chronic Thrombembolic Pulmonary Hypertension (first-in-man study).


nos: 825 844 TCT-825 Simplicity Denervation System for Pulmonary Artery Denervation in Patients with Chronic Thrombembolic Pulmonary Hypertension (first-in-man study) Boris Rudenko, Artem Shanoian, Sergey Boytsov, Oksana Drapkina, Svetlana Beregovskaya, Anna Akhadova, Daria Feshchenko, Vsevolod Vlasov, Firdavs Shukurov, Alexandr Koltunov, Sergey Dzemeshkevich, Yulia Frolova Moscow, Russian Federation; Nat. Rsrch Ctr for Preventive Med., Moscow, Russian Federation; National Center for Preventive Medicine; National Center for Preventive Medicine; National Center for Preventive Medicine; National Center for Preventive Medicine; National Center for Preventive Medicine; National Center for Preventive Medicine; National Center for Preventive Medicine; Central Military Hospital; National Center for Surgery; National Center for Surgery BACKGROUND The goal of our study was to evaluate the safety and effectivenessofSimplicitydenervationsystemin loweringpulmonaryartery pressure inpatientswith chronic thromboembolicpulmonaryhypertension. METHODS Patients with the chronic thromboembolic pulmonary hypertension (defined as mean pulmonary artery pressure > 25) were eligible for the study. A total of 12 patients were included. All patients were on the multidrug theraphy, including sildenafil. Functional capacity was determined by the 6MWT performed 1 week prior and 3 months following the PADN procedure. The right heart catheterization, hemodynamic measurements and blood oxygen saturation data from the RA, RV, and PA were done before the PADN procedure. The PVR [PVR 1⁄4 (mean PAP d PAOP)/CO] was calculated. The PADN procedure was made by Simplicity 6 Fr-compatible radiofrequency ablation catheter inserted through the coronary guiding catheter. Ablation was perfored at the bifurcation level of the main PA and at the ostium of the left and right PA. Procedural success was defined as a reduction in the mean PAP >10 mm Hg (as measured by guiding catheter at the end of ablation), and there were no complications. The primary endpoints were improvement of functional capacity by the 6MWT and mean PAP at 3 months. RESULTS During and immediately following the PADN procedure, no complications (death, arrhythmias, PA perforation, acute thrombus formation in the PA or in the femoral vein, bleeding) were recorded. During 3-months of follow-up no rehospitalization was required. All patients reported no deterioration of the symptoms and no complications were registered. 9 patients noticed significant improvements in dyspnea and fatigue, in all patients sildenafil was discontinued. After 3 months all patients underwent right heart catheterization and functional capacity measurements. At 3 months follow-up the reduction of mean pulmonary artery pressure was 25 mm Hg (from 58 6 to 33 4 mm Hg) (p < 0.01) and improvement of the 6 minutes walking test from 321 19 m to 487 29 m (p < 0.01) was observed. CONCLUSION The Simplicity denervation system is proven to be safe and effective for pulmonary artery denervation. Further randomized study is needed to confirm the clinical benefit of this procedures in patients with pulmonary hypertension. CATEGORIES OTHER: Pre-Clinical/First In-Human Studies TCT-826 Prospective single center First In Human (FIH) clinical trial to evaluate the safety and effectiveness of a septal occluder with bioresorbable framework in patients with clinically significant atrial septum defect (ASD) or patent foramen ovale (PFO) Björn Söderberg, Laura Vaskelyte, Sameer Gafoor, Ilona Hofmann, Andreas Mellmann, Jerome Bernhard, Horst Sievert Atlanticare Medical Center; University of Missouri-Columbia, Frankfurt am Main, Germany; CardioVascular Center Frankfurt, Frankfurt, Germany; CVC, Frankfurt/Main, Germany; Carag, Baar, Switzerland; Unknown, Zurich, Switzerland; CardioVascular Center Frankfurt CVC, Sankt Katharinen, Frankfurt, Germany BACKGROUND The objective of this trial is to investigate the effectiveness and safety of a new septal occluder with bioresorbable framework (Carag Bioresorbable Septal Occluder CBSO, CARAG AG, Switzerland) in the treatment of secundum ASD or PFO. Device closure of ASD/PFO is standard of care in most countries. Current devices use a metal framework and occlusive patch material. Metal frameworks are reported to cause serious complications (eg erosion, perforation, arrhythmia) as late as 10 years following implantation. A septal occluder with bioresorbable framework has long been desired. Until now, development of a clinically effective bioresorbable framework has been elusive. We report on the initial 14 subjects implanted at the CardiovascularCenter, Frankfurt. METHODS The CBSO employs a poly lactic-co-glycolic acid (PLGA) framework with polyester patches. Available in 3 sizes, it treats defects 25mm balloon diameter. It is delivered over a guidewire via a 12F transseptal sheath under fluoro/TEE guidance. Follow-up is at 1, 6, 12 and 24 months & includes clinical examination echo, ECG & blood panel. Closure effectiveness is determined by TEE at 6 months. In this FIH trial, only ASD with atrial rims 5mm or PFO tunnels 4mm are treated. RESULTS 14 patients (age 50.5 11.4 years) have been treated: ASD (n1⁄48) ranged from 12.9-21mm in diameter, PFO (n1⁄46) ranged from 5.4-10.8mm in diameter. All devices were successfully implanted without complication. Mean time for loading and placement was 30 25.0 minutes. At 6 months, echo exam showed complete closure in 4/6 PFO patients and complete closure in 6/7 ASD and one small residual shunt (2mm). TTE at long term follow-up (2 at 24 months; 8 at 12 months) confirmed flat septum and showed no re-canalization. There have been no procedure or device related serious adverse events, no thrombus formation and no new occurring arrhythmias during follow-up. CONCLUSION CBSO is the first clinically effective septal occluder with a bioresorbable framework. It can be easily and safely implanted in humans with excellent closure results at procedure and long term. A learning curve may be required. Additional patients and longer follow-up is needed to further assess outcome. CATEGORIES OTHER: Pre-Clinical/First In-Human Studies TCT-827 Abstract Withdrawn TCT-828 Very Late Vasomotor Responses and Gene Expression Profiles of Porcine Coronary Arteries at 4 Years after Deployment of the Everolimus-eluting Bioresorbable Vascular Scaffold and the Everolimus-eluting Metallic Xience V stent Bill D. Gogas, sandeep kumar, James Benham, Deepal Panchal, Yasir Bouchi, Olivia Hung, Rounak Gandhi, Nikolaos Spilias,

DOI: 10.1016/j.jacc.2016.09.854

Cite this paper

@article{Rudenko2016TCT825SD, title={TCT-825 Simplicity Denervation System for Pulmonary Artery Denervation in Patients with Chronic Thrombembolic Pulmonary Hypertension (first-in-man study).}, author={Boris Rudenko and Artem Shanoian and Sergey A. Boytsov and Oksana Drapkina and Svetlana Beregovskaya and Anna Akhadova and Daria Feshchenko and Vsevolod Vlasov and Firdavs Shukurov and Alexandr Koltunov and Sergey L Dzemeshkevich and Yulia V Frolova}, journal={Journal of the American College of Cardiology}, year={2016}, volume={68 18S}, pages={B334} }