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Early outcomes from Post Market Observational study on Zenith® t-
Branch® endograft
Michel J. Bosiers, MD
Consultant Vascular and Endovascular Surgery
St. Franziskus-Hospital Münster
Director: Prof. G. Torsello
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Disclosure
Speaker name: Michel Bosiers
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)
I do not have any potential conflict of interest
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CMD- FEVAR/BEVAR:
Well established for about 15 years.
Limitation: Waiting-time for the CMD.
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Off the shelf: T-BRANCH (COOK) Unibody34mm
18 mm
202 mm
81, 98, 115, 132 mm
22 mm
T-BRANCH:CE-marked 2012
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< 50mm
>67 mm
Renal
artery cuff
Gasper et al. J Vasc Surg 2013;57:1153-5
Bisdas et al. J Endovasc Ther 2013;20:672-77
IFU intended useHigh-risk TAAA patients not amenable to open
surgical repair, with suitable morphology
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57%
63%
• 10% unsuitable renovsiceral
configuration
• 13% previous EVAR
or open AAA repair
• 7% >90° axial deviation
cuff-target vessel
• 21% >56mm distance CT – RA
• 12% <25mm diameter
renovisceral segment, TBAD
Suitability for t-Branch
Gasper et al. J Vasc Surg 2013;57:1153-5
Bisdas et al. J Endovasc Ther 2013;20:672-77
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0
10
20
30
40
50
10
20
30
40
50
✓ Longer BSG available :
VBX : 79mm
✓ Combination of BSG
✓ TBE prox. Extension 77 or 81mm
✓ Or combination with other Zenith
thoracic endografts:
TX2 with ProForm platform includes a
wide range of Tapered and Non-
Tapered components
• No waiting time
• Easy planning
• Forgiving
T-Branch
6 7 8 9 10 11 12 1 2 3 4 5 6
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Ruptured Aneurysms
1Spanos K, et al. Early Outcomes of the t-Branch Off-the-Shelf Multibranched Stent-Graft in Urgent Thoracoabdominal Aortic Aneurysm Repair.J Endovasc Ther. 2018;25:31-39.
2Gallitto E, et al. Off-the-shelf multibranched endograft for urgent endovascular repair of thoracoabdominal aortic aneurysms. J Vasc Surg. 2017 Sep;66(3):696-704.3Hongku K, et al. Mid-term Outcomes of Endovascular Repair of Ruptured Thoraco-abdominal Aortic Aneurysms with Off the Shelf Branched Stent Grafts.
Eur J Vasc Endovasc Surg 2018;55:377-384.
• Hamburg group1:
42 patients, 55% within IFU 93% technical success
• Bologna group2:
17 patients, 87% adj. procedures 82% technical success
• Malmö group3:
11 ruptured patients, 18% within IFU 64% technical success
Feasible with adjunctive procedures
18 symptomatic TAAA, 12 contained rupture, 12 TAAA diameter >=8 cm
4 contained TAAA rupture, 4 symptomatic TAAA (pain or peripheral embolism), 9 TAAA diameter >=8 cm
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Case
• Female, 68y
• Symptomatic TAAA 6cm
• TAA 5,5cm, symptomatic
• Occluded left hypogastric artery
• Previous transabdominal bowel resection (CA)
• Previous ovariectomy,
complicated by bowel and bladder injury
• Multiple redo surgeries for adhesions
and anastomosis insufficiency
• AHT, HLP, hypothyreosis
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Case
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Case
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Case
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Case
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Case
SMA
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Case
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Case
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Case12 days later: attachement of CT
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Case
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Case 2
• Male 84y
• Symptomatic TAAA Type 4, 6cm
• AHT• CAD, previous MI• COPD
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Case 2
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Case 2
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Case 2
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Case 2
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Case 2
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Case 2
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Zenith t-Branch Post-Market Observational Study
Early outcomes
Sponsored by Cook Medical
Clinical Trial Registration: NCT02104089
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• ObjectiveTo evaluate the t-Branch TAAA endovascular graft used in routine clinical care
• Study design– Observational, multicenter– 80 patients, prospective or retrospective– Placement of the t-Branch device in accordance with the IFU
• Study outcomes– Primary: Procedure-related mortality and morbidity at 30 days– Secondary: Longer-term mortality and morbidity, procedural
outcomes, patency of the graft and bridging stents, device integrity, endoleaks, aneurysm growth and secondary procedures at follow up
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Patient Enrollment
• A total of 80 patients were enrolled between September 2012 and November 2017
InstitutionNumber of
Patients(Retrospective,
prospective)
St. Franziskus Hospital, Münster, Germany 39 (29, 10)
University Heart Center, Hamburg, Germany 34 (29, 5)
Skåne University (SU), Malmö, Sweden 7 (5, 2)
Total 80 (63, 17)
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Disease Treated 80 patients
Aneurysm
96%
(77/80)
Dissection
4%
(3/80)
Type III
18%
(14/77)
Type IV
34%
(26/77)
Type I
7%
(5/77)
Type II
38%
(29/77)
Stable: 4
Symptomatic: 0
Contained
Rupture: 1
Stable: 22
Symptomatic: 2
Contained
Rupture: 5
Stable: 12
Symptomatic: 1
Contained
Rupture: 1
Stable: 16
Symptomatic: 3
Contained
Rupture: 7
Reason for
treatment
Crawford
Classification
Aneurysm
Status
Mean maximum aneurysm diameter: 71.2 ± 18.3 mm
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Patient Characteristics
Comorbid Conditions (cont.)
% (n/N)
Pulmonary
COPD 22.5% (18/80)
Renal
Dialysis 3.8% (3/80)
Chronic renal insufficiency 30.0% (24/80)
Endocrine
Diabetes 10.0% (8/80)
Neurologic
Stroke 10.0% (8/80)
Smoking
Current or past 52.5% (42/80)
DemographicsMean ± SD, or %
(n/N)
Demographics
Age (years) 71.0 ± 7.4
Male 70.0% (56/80)
Comorbid Conditions % (n/N)
Cardiovascular
Myocardial infarction 13.8% (11/80)
Congestive heart failure 3.8% (3/80)
Coronary artery disease 35.0% (28/80)
Cardiac arrhythmia 13.8% (11/80)
Vascular
Peripheral vascular disease 20.0% (16/80)
Hypertension 83.8% (67/80)
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Procedural Measures
Mean ± SD, or % (n/N)
Anesthesia
General 98.7% (79/80)
Regional 1.3% (1/80)
Access
Percutaneous 55.0% (44/80)
Cutdown 40.0% (32/80)
Conduit 5.0% (4/80)
Procedure time (min) 369.3 ± 128.4
Fluoroscopy time (min) 81.9 ± 38.9
Contrast volume (cc) 182.2 ± 70.3
Duration of ICU stay (days) 5.9 ± 6.6
Duration of hospital stay (days) 14.6 ± 10.9
• In 1 patient, the Zenith t-Branch device could not be inserted during the index procedure.
Learning curve Extensive repair
Additional components
• TX2 proximal: 51% (40/79)
• TX2 distal: 22% (17/79)
• TX2 PE: 20% (16/79)
• Distal body: 68% (54/79)
• Iliac graft
– Left: 59% (47/79)
– Right: 62% (49/79)
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Branch Stent Placement - Covered
Celiac SMALeft
renalRight renal
# Vessels with covered stent placement
68 77 74 76
# Covered stents placed 87 106 114 104
Advanta/iCAST(Getinge AB; Getinge, Sweden)
36 61 48 45
Begraft(Bentley Innomed; Hechingen, Germany)
9 1 11 9
Covera(C.R. Bard; Covington, GA)
1 0 1 5
E-ventus(JOTEC; Hechingen, Germany)
0 1 3 2
Fluency (C.R. Bard; Covington, GA)
29 33 11 11
Viabahn(Gore Medical; Flagstaff, AZ)
12 10 40 32
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Branch Stent Placement -Uncovered
Celiac SMALeft
renalRight renal
# Vessels with uncovered stent placement
49 65 49 53
# Uncovered stents placed 55 79 61 68
Complete(Medtronic; Minneapolis, MN)
14 17 5 7
Everflex(Medtronic; Minneapolis, MN)
7 25 31 31
Flexive(Boston Scientific; Marlborough, MA)
0 0 0 2
Genesis(Cordis; Santa Clara, CA)
19 19 16 18
Omnilink(Abbott; Chicago, IL)
2 1 0 0
SMART (Cordis; Santa Clara, CA)
12 16 3 6
Visi-Pro(Medtronic; Minneapolis, MN)
1 0 4 4
Zilver Flex(Cook Medical; Bloomington, IN)
0 1 2 0
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Early Imaging Findings
Post-procedure CT according to the standard of care at each site:
• No stent-graft fracture, component separation, or barb separation
• 100% patency for t-Branch main body and attached branches (i.e., with branch stent placement)
• Endoleak
• Type Ia: 5.6% (4/72)
• 2 resolved spontanously, 1 with reintervention, 1 without intervention
• Type III: 8.3% (6/72)
• 2 between mainbody grafts, 2 associated with intentionally open branch/limb to presnt SCI, 1 at an occluded renal branch, 1 at an unknown location
• Type II: 41.7% (30/72)
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30-Day Clinical Outcomes
• 1 death within 30 days, procedure-related
Patient died on POD 30, one day after experiencing multiorgan failure, CT no endoleak, branches patent
% (n/N)
All-cause mortality 1.3% (1/80)
Rupture 0% (0/80)
Conversion 0% (0/80)
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30-Day Clinical Outcomes
Adverse Events (cont.) % (n/N)
Access site
Infection 2.5% (2/80)
Hematoma 1.3% (1/80)
Bleeding 2.5% (2/80)
Vascular
Occlusion of a branch vessel 1.3%
(1/80)a
Other notable events
Multiorgan failure 1.3% (1/80)
Suspected mesenteric ischemia 1.3% (1/80)
Adverse Events % (n/N)
Cardiovascular
Cardiac ischemia requiring
intervention1.3% (1/80)
Pulmonary
Pneumonia 1.3% (1/80)
Neurologic
Stroke 3.8% (3/80)
Paraplegia 1.3% (1/80)
Paraparesis 7.5% (6/80)
Renal
Renal insufficiency 2.5% (2/80)
Renal failure requiring dialysis 2.5% (2/80)
a This patient had bilateral renal artery occlusion on POD 24 while in hospital (patient had heparin-induced thrombocytopenia unknown at the time of procedure) and experienced renal insufficiency. Occlusion was treated with thrombectomy.
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30-Day Secondary Interventions
POD Reason for Secondary Intervention
Treatment
9 Uncovered celiac stent stenosis Stent placement
14 Proximal Type I endoleak Stent-graft placement
19 Left internal iliac artery stenosis Stent placement
24 Bilateral renal branch occlusion Thrombectomy
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Freedom from Secondary Interventions
Freedom from secondary interventions: 88.8% ± 3.5% at 365 days
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Secondary Interventions 31-365 Days
POD Reason for Secondary Intervention Treatment
50Celiac branch unstented intentionally during the index procedure
Celiac stent placement
130 Distal Type Ic endoleak (at covered SMA stent) SMA Stent placement
217 Occlusion of right renal stent Renal stent placement
325Stenosis of left renal stent,Type III endoleak between t-Branchand right renal stent
Renal stent placement, angioplasty
356 Type III endoleak at broken coverage of celiac stent Celiac stent placement
• A total of 9 patients with secondary interventions within 1 year
– 4 patients within 30 days (as shown earlier)
– 5 patients between 31-365 days
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Freedom from All-Cause Mortality
Freedom from all-
cause mortality
88.8% ± 3.5% at 365
days
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• This is one of the few multicenter, observational, post-market studies on
the off-the-shelf Zenith t-Branch endovascular graft
• The t-Branch repair appears safe with good 30-day mortality and
morbidity results in both stable and symptomatic cases treated under
routine clinical care
• The T-Branch design leads to a broad applicability also in urgent cases.
• Planning is easy and Implantation is a very save and straight forwardprocedure.
• Sec. procedures can be done by endovascular means.
• T-Branch for emergency cases saves lifes!
Conclusion
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Early outcomes from Post Market Observational study on Zenith® t-
Branch® endograft
Michel J. Bosiers, MD
Consultant Vascular and Endovascular Surgery
St. Franziskus-Hospital Münster
Director: Prof. G. Torsello