Arch Repair with the Bolton Medical RelayBranch Thoracic Stent-graft system: Multicenter experience
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1 Arch Repair with the Bolton Medical RelayBranch Thoracic Stent-graft system: Multicenter experience Joost van Herwaarden, MD, PhD University Medical Center, Utrecht
2 Disclosure I have the following potential conflicts of interest to report: Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s): Proctor agreement with Bolton medical and Cook
3 Conventional Open repair of Aortic Arch aneurysms Associated with significant perioperative morbidity and mortality Risk of stroke up to 12% Mortality 7-20% Mean age 63 yrs Semin Thorac Cardiovasc Surg 2009;21:347
4 Hybrid Procedures
5 OR (n=25) HR (n=21) Mean age (yrs) Mortality 20% 19% Permanent stroke 17% 21% ICU stay (days) * Hospital stay (days) 29 24
6 Hybrid Procedures = Less invasive But the aim is minimal invasive What we need are probably total endovascular interventions
7 Endovascular Aortic Arch Repair Challenges of the aortic Arch Aortic curvature Trackability/ Bird beak phenomena Supra aortic target vessels Patency / Stroke risk / Endoleak Dynamic Environment Migration / Disconnections / stent fracture
8 RelayBranch Thoracic Stent-Graft Device is not commercially available Patients are treated via the Custom Made program Device based on Relay Non-Bare Stent (NBS) Technology Intended for Zone 0 deployment
9 RelayBranch: Design Overview Based on RELAY NBS PLUS: DUAL SHEATH SYSTEM PRE-CURVED NITINOL INNER CATHETER Tracking through the arch, the pre-curve enhance the alignment of the stentgraft INNER SHEATH Flexible inner sheath allows atraumatic advancement OUTER SHEATH Provides support / pushability during delivery and protects access vessels by acting a conduit for the inner sheath.
10 RelayBranch: Design Overview Based on RELAY NBS PLUS SUPPORT WIRES Provides controlled stent-graft expansion avoiding the retroflex & bird s beak effect PROXIMAL CLASPING Two clasping points located on the outer curve allow repositioning of the device and prevent windsock effect.
11 RelayBranch: Design Overview Wide window gives access to two antegrade 12mm inner branches ( tunnels ) Brain perfusion is preserved during the procedure due to Flow through the tunnels directly after deployment of the graft Catheterization of the tunnels from the LCCA and BCT is in general easy 2 Internal Tunnels
12 RelayBranch: Design Overview Lock-Stent 13mm Diameter Tunnels feature Lock- Stent with rounded barbs, that prevents branch disjunction Branches are available in wide range of sizes
13 Case Female 76 yrs Severe COPD 2011 TEVAR after left carotid-subclavian bypass Type IA and IB endoleak Rejected for open repair
14 Case
15 Case
16 Experiences To date 120 pts are treated with RelayBranch stentgrafts worldwide
17 Experiences 15 pts from 4 centers (Freiburg, Toulouse, Tübingen and Utrecht) EJCTS doi: / ejcts/ezx493
18 Demographics / comorbidities Median Age 76 yrs (IQR 74-82) 12 (80%) Male, 3 Female Mean Aneurysm size 6.3cm 47% COPD 27% Renal insufficiency 40% Coronary artery disease Previous coronary bypass n=1 Previous aortic surgery 60% All patients rejected/ unfit for open repair
19 Results Perioperative 93.3% technical success (1 self-limiting type Ib) Mortality n=1 (6.7%) (after 2 wks, myocardial infarction & stroke) Non-disabling stroke n=2 (13.3%) Follow-up (median 263 days, IQR ) 0 % Type I/III endoleaks 100% Patency graft & target vessels 1 (6.7%) Re-intervention (Type II el from LSCA) 0% Aortic related death 0% Aneurysm growth
20 Summary Positive experiences with RelayBranch for total endovascular arch repair Safe & feasible technique for treating aortic arch Mortality and disabling stroke(6.7%) are limited Low re-intervention rate (6.7%) 2 (13.3%) patients with temporally symptoms stroke Important to optimize endovascular techniques, especially to minimize numbers of strokes Further studies are needed to confirm results and the long-term durability
21 Thank you
22 Arch Repair with the Bolton Medical RelayBranch Thoracic Stent-graft system: Multicenter experience Joost van Herwaarden, MD, PhD University Medical Center, Utrecht
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