title: Worldwide results from the RESTORE II on elective endografting of thoracic aneurysms and dissections.
abstract: OBJECTIVE
  To assess safety, performance, and efficacy of the RELAY thoracic stent graft (Bolton Medical, Barcelona, Spain) in the treatment of patients who require elective thoracic endovascular aortic repair including aneurysms and dissections.
  
  
  METHODS
  The RELAY Endovascular Registry for Thoracic Disease II (RESTORE II) is a multicenter, prospective, international cohort study involving 21 centers in 12 countries worldwide. All consecutively included patients underwent elective thoracic endovascular aortic repair with a RELAY or RELAY NBS stent graft (including off the shelf and custom-made devices) to repair thoracic aortic aneurysms or dissections. Demographic, clinical, and aortic parameters were Web-based registers. Safety and efficacy data were collected for a follow-up period of 24 months. RESTORE was a precedent registry involving European sites that used RELAY first-generation devices.
  
  
  RESULTS
  A total of 173 patients were enrolled in the registry from October 2010 to September 2014 (aneurysm [n = 99]/dissection [n = 74]). Overall technical success of the intervention reached 97.1% irrespective of the etiology and geographic origin of patients. Baseline clinical heterogeneity was observed between devices concerning the etiology of the disease and certain comorbidities and/or risk factor distribution (diabetes, hypertension, myocardial infarction, angina pectoris). An average of 1.36 stent graft components were used per patient, with mean intended treatment length of 197.0 ± 87.7/188.7 ± 103.1 mm and mean access site diameter of 10.3 ± 8.2/9.7 ± 1.7 mm in aneurysms/dissections, respectively. The rate of all-cause 30-day mortality was lower than in the RESTORE registry (4.0% vs 7.2%). Perioperative neurologic complications were infrequent: paraplegia/paraparesis (2.9%) and stroke (0.6%) (vs 2.0% and 1.6% in the RESTORE registry). Freedom from all-cause mortality at 2 years was 93.6%. At the final completion angiography, device-associated complications were detected in 4.6% of the patients (vs 5.3% in the RESTORE) and endoleak rate was 6.4% (type I 5.8% and type II 1.7%).
  
  
  CONCLUSIONS
  The worldwide results of the RESTORE II registry show the safety and effectiveness of RELAY and RELAY NBS stent grafts for elective endovascular thoracic aortic repair. Compared with the RESTORE registry, the device presents a lower rate of perioperative complications.
authors.affiliation: Department of Cardiothoracic and Vascular Surgery, German Heart Institute Berlin, Berlin, Germany.
authors.forename: Burkhart
authors.initials: B
authors.lastname: Zipfel
authors.affiliation: Department of Vascular Surgery, Cardiovascular Institute of Buenos Aires, Buenos Aires, Argentina.
authors.forename: Patricio
authors.initials: P
authors.lastname: Zaefferer
authors.affiliation: Vascular Surgery Division, Hospital Clinic of Barcelona, Barcelona, Spain. Electronic address: vriambau@clinic.ub.es.
authors.forename: Vicenç
authors.initials: V
authors.lastname: Riambau
authors.affiliation: Department of Vascular Surgery, Semmelweis Medical University, Budapest, Hungary.
authors.forename: Zoltán
authors.initials: Z
authors.lastname: Szeberin
authors.affiliation: Department of Cardiothoracic and Vascular Surgery, University Medical Center, Mainz, Germany; Academic Hospital Hubertus, Berlin, Germany.
authors.forename: Ernst
authors.initials: E
authors.lastname: Weigang
authors.affiliation: Cardiology Service, Cooperativa Médica Limitada, Concepción, Argentina.
authors.forename: Marcelo
authors.initials: M
authors.lastname: Menéndez
authors.affiliation: Department of Cardiovascular and Interventional Radiology, Vienna General Hospital, Vienna, Austria.
authors.forename: Martin
authors.initials: M
authors.lastname: Funovics
authors.affiliation: Faculty of Medicine, Department of Surgery & Cancer, Imperial College London, St Mary's Hospital, London, United Kingdom.
authors.forename: Mohamad
authors.initials: M
authors.lastname: Hamady
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000784:Aortic Dissection / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D017545:Aortic Aneurysm, Thoracic / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D017558:Elective Surgical Procedures; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome