Early experience with the new Bolton TREO abdominal
stent-graft
Ciro Ferrer, MDFisiopatologia Chirurgica ad Interesse Vascolare
Sapienza Università di RomaDirettore: Prof. L. di Marzo
Disclosure
Speaker name:
Ciro Ferrer
I have the following potential conflicts of interest to report:
Consulting: Bolton Medical
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest
X
Stentgraft design
Adjustable leg landing zones for versatile treatment and adjustment to the distal landing zone
30mm Ipsilateral
Adjustable Zone
10mm Contralateral
Adjustable Zone
Active FIXATION within stent modules with the unique Lock-Stent to avoid modular disconnection
IpsilateralLock Stent
ContralateralLock Stent
1
2
LOCK STENT TECHNOLOGHY
Rounded barbs located at the base of
main body lock stent are designed
specifically to engage with leg
extensions to add resistance against
module disconnection and deliver safe
variable distal adjustment
LOW PROFILE DELIVERY SYSTEM
ADVANCED
HEMOSTASIS VALVE
Double valve mechanisms, one passive
and one active with 10 different positions,
secures hemostasis
TWO WAY FLUSH PORT
DETACH MECHANISM
DETACHABLE SHEATH
The sheath detaches from the Delivery
System providing less access vessel
manipulation and quicker access
PRECISE DELIVERY SYSTEM
The mechanical deployment provides
controlled and stable stent- graft deployment
MAIN BODY D.S. LEG EXTENSION D.S.
30 to 36mm 20 to 28mm 9 to 15mm 17 to 24mm
19 F. (OD) 18 F. (OD) 13 F. (OD) 14 F. (OD)
The overlap of the two first proximal stents provides optimal sealing even in tortuous anatomies
• TREO is indicated in neck lengths of:
– 10 mm or greater with an infrarenal angle of less than 60 degrees
– 15 mm or greater with an infrarenal angle between 60 and 75 degrees
10mm
Male, 67 yoHypertensionHyperlipidemiaCAD (previous PTCA)
Vessel analysis
10 mm
Bolton TREO is the only designed with both suprarenal and infrarenal active fixation
SUPRARENAL FIXATION
Suprarenal laser cut barbs allow for
primary proximal fixation once deployed
INFRARENAL FIXATION
Infrarenal laser cut barbs provides
supplemental fixation. Forces increases
proportionally with the infrarenal angulation
The infrarenal barbs highly contribute to migration resistance in large angulated necks
Infrarenal Barb Contribution Alone
6.41 N
Small Angle Large Angles
1-2 Barbs Engaged
5.9 N 9.75 N50% Increase
12.88 N100% Increase
Straight
SUPRARENAL FIXATION
Suprarenal barbs are completely covered
during deployment until release of the
bare stent
INFRARENAL FIXATION
Infrarenal barbs are obscured in
“valleys” prior to final deployment
Male, 80 yoHypertensionPrevious pulm lobectomyAtrial fibrillation
Enhanced DeliveryTREO’s Proximal Clasp
Forward Movement Required to Recapture
Recapture Avoided
Endurant II & IIs are known for snagging during system removal
TREO’s proximal clasp is designed to smoothly remove and not snag on the
bare stent.
Enhanced DeliveryTREO’s Proximal Clasp
RATIONALE REGISTRY
STUDY DEFINITION
A Post-Market Surveillance Clinical Registry
STUDY DESIGN
- Prospective
- Multicentric
- International
- EDC (Electronic Data Capturing) System
RATIONALE REGISTRY
PRIMARY ENDPOINT
Safety: Mortality & Morbidity (Stroke, MI, Renal Failure, Respiratory
complications, paraplegia, ischemia)
Efficacy: Aneurysm related mortality
SECONDARY ENDPOINT
Delivery / Deployment; Migration; Patency; Integrity; Endoleak; Aneurysm Sac
Size Changes; Limb Ischemia; Vascular Access Complications; Unintentionally
covering renal arteries and / or hypogastric arteries
• PARTICIPANTS
• 17 Countries• 12 Europe
• 3 Asia
• 2 Latin America
• 32 Sites
• 202 Patients enrolled
GLOBAL REGISTRY
SITES BY REGION
3 3
26
26 Europe
3 Asia
3 Latin America
Europe
EUROPEAN INSTITUTIONS
DE - Bonifatius Hospital Lingen
DE - Theresienkrankenhaus und St. Hedwig-Klinik
DE - Universitätsklinikum Tübingen
DE - Deutsches Herzzentrum Berlin
IT - Casa Di Cura Villa Dei Fiori
IT - Azienda Ospedaliera San Camillo Forlanini
IT – Azienda Ospedaliera Universitaria Senese
UK - Manchester Royal Infirmary. Central Manchester University Hospitals
UK - John Radcliffe Hospital. Oxford UniversityHospitalsUK - Addenbrooke's Hospital. Cambridge UniversityHospitals
UK - Hospital Germans Trias i Pujol Hospital
ES - Hospital Clinic Barcelona
ES - Complexo Hospitalario Universitario de Ourense
ES - Hospital Universitario Ramón y Cajal
ES - Hospital HM Modelo
NL - ZiekenhuisGroep Twente
NL - University Medical Center Utrecht
PL - Samodzielny Publiczny Szpital Kliniczny Nr 1 in Lublin
GR - Georgios Gennimatas" Thessaloniki General Hospital
GR - Evangelismos General Hospital
HU - Semmelweis Medical University Budapest
SE - Karolinska University Hospital
SE - Linköping University Hospital
IR - Cork University Hospital
DK - Rigshospitalet, National Hospital and University ofCopenhagen
NO - Haukeland University Hospital
Latin American
Asia
CL - Hospital Barros Luco Trudeau
CL - Fondo Hospital Dirección Previsión de Carabineros Dipreca
VE - Urológico San Román
HK - The University of Hong Kong
VN - Ray Hospital
TH - Lampang Hospital
INTERNATIONAL INSTITUTIONS
Number patients included at Follow-Up N %
1 Month FU 194 96,0
OUTCOMES
1 Month FU 6 Month FU 12 Month FU
6 Month FU 72 35,6
12 Month FU 31 15,3
Complications
Implant
N = 202 (%)
1 Month FU
N = 194 (%)
Device Integrity Maintained 202 (100) 194 (100)
Conversion to Surgery 0 (0) 0 (0)
Stent graft Migration ≥ 10 mm 0 (0) 0 (0)
Graft Patency 202 (100) 194 (100)
Mortality N
Aneurysm Related Mortality 0
Non Aneurysm Related Mortality 0
All Cause Mortality 0
Mortality and major adverse events
Endoleak Type 1 monthN = 194 (96%)
Type Ia 2 (1,0)
Type Ib 2 (1,0)
Type II 26 (12,4)
Type III 0 (0)
Others 0 (0)
Total 30 (13,4)
ENDOLEAK RATE AT FOLLOW-UP
Endoleak
60
50
N=1
9459,2 mm55
55,9mm
Screen 1 month VISIT
MAXIMUM DIAMETER OF LESION: Mean Values (mm)
mm
65
N=202
Aneurysm Sac Size Changes
- 96% technical success
- At 1 month 2% type I endoleak with 0% type III & IV
- 0% mortality and migration at 30 days
- 14% sac decrease at 6 months
- At 6 months no conversion to surgery, no migration, tears nor fractures
- No procedure-related mortality
RATIONALE REGISTRY
Customized solutions available within theTreo custom made program
CUSTOM SOLUTIONS
Current available designs
• Tapers
• Reverse/Extreme Tapers
• Extreme Lengths
• Scallop
• Single Fenestration
Future available designs
• Double Fenestration
• Double Fenestration w/Scallop
DELIVERY TIME
3 weeks (From design approval to delivery)
Courtesy of Prof. Carlo SetacciAzienda Ospedaliera Universitaria Senese
Early experience with the new Bolton TREO abdominal
stent-graft
Ciro Ferrer, MDFisiopatologia Chirurgica ad Interesse Vascolare
Sapienza Università di RomaDirettore: Prof. L. di Marzo
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