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

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

CMD- FEVAR/BEVAR:

Well established for about 15 years.

Limitation: Waiting-time for the CMD.

Off the shelf: T-BRANCH (COOK) Unibody34mm

18 mm

202 mm

81, 98, 115, 132 mm

22 mm

T-BRANCH:CE-marked 2012

< 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

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

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

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

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

Case

Case

Case

Case

Case

SMA

Case

Case

Case12 days later: attachement of CT

Case

Case 2

• Male 84y

• Symptomatic TAAA Type 4, 6cm

• AHT• CAD, previous MI• COPD

Case 2

Case 2

Case 2

Case 2

Case 2

Case 2

Zenith t-Branch Post-Market Observational Study

Early outcomes

Sponsored by Cook Medical

Clinical Trial Registration: NCT02104089

• 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

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)

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

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)

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)

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

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

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)

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)

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.

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

Freedom from Secondary Interventions

Freedom from secondary interventions: 88.8% ± 3.5% at 365 days

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

Freedom from All-Cause Mortality

Freedom from all-

cause mortality

88.8% ± 3.5% at 365

days

• 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

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