Systematic multi-staged endovascular repair of

thoracoabdominal aneurysms with fenestrated and branched endografts (STEAR study)

Loschi Diletta

Vascular Surgery, “Vita-Salute” - San Raffaele UniversityScientific Institute Ospedale San Raffaele, Milan – Italy

Chief: Prof. R. Chiesa

I have the following potential conflicts of interest to report:

Receipt of grants/research support

Receipt of honoraria and travel support

Participation in a company sponsored speakers‘ bureau

Employment in industry

Shareholder in a healthcare company

Owner of a healthcare company

I do not have any potential conflict of interest

Disclosures

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BackgroundStaged TAAAs open aortic procedures

Etz CD et al. J Thorac Cardiovasc Surg 2010 O'Callaghan A et al. J Vasc Surg 2015

San Raffaele STaged Endovascular Repair protocolProgressive thrombosis of intercostal and lumbar arteries

Thoracic step Visceral step Limb stepType II TAAA

STaged Endovascular Repair (STEAR) study

Population: 67 patients treated with staged F/BEVAR - 44 patients retrospective (Jan. 2013 – Nov. 2017)

- 23 patients prospective (Dec. 2017 – present)

Inclusion criteria : no pararenal aneurysms or emergencies (6 cases), only elective TAAAs

Primary endpoint: Clinical success and spinal cord ischemia rates

Status: Recruiting

ClinicalTrials.gov Identifier: NCT03342755

Intersurgical intervals Median overall treatment time interval: 97 days (IQR 59-127)*

Thoracic step50 cases (75%)

Visceral step64 cases (96%)

Limb step24 cases (36%)

70 days 18 days

*T-branch interval: 40 days (IQR 30-65)

1st step: proximal TEVAR50 cases (75%)

Local anesthesia 27 (54%)

Percutaneous 37 (74%)

Preop. CSFD 0%

PLZ 0-2 arch 10 (20%)

LSA revascularization 9/10 (90%)

Rapid pacing 9/10 (90%)

Mean procedural time 85 min

ICU stay 3 (6%)

Lenght of hospital stay3 (IQR 3 – 4)

daysProximal thrombosis

Custom made thoracic componentsAvoid unnecessary thoracic coverage: waiting time 1 week

a. Extra tapered short component b. “2 in 1” thoracic component

Bertoglio et al. J Vasc Surg 2018

2nd step: FEVAR / BEVAR

64 cases – Intersurgical interval: 70 days (IQR 47-113)

Local anesthesia 31 (46%)

Totally percutaneous 42 (67%)

CSFD 7 (11%)

Self-expandable covered 31%

Ballon-expandable covered 69%

Target vessel loss 2%

Bare reinforcement 34%

Median procedural time 310 min

Need for ICU stay 14 (22%)

Lenght of hospital stay 5 days (IQR 4 - 6)

Bertoglio et al. J Vasc Surg 2018

Percutaneous axillaryaccess

3rd step: controlateral limb24 cases (36%) – Intersurgical interval: 18 days (IQR 11-25)

Local anesthesia 15 (63%)

Percutaneous 18 (75%)

CSFD 1 (4%)

Mean procedural time 54 min

ICU stay 0

Lenght of hospital stay 3 (IQR 2-5)

Contralateral limbdeployment

1st Step Interval 2nd Step Interval 3rd Step Cumulative Results

Clinical success - - - 50 (75%)

Related Mortality 1 1 1 1 4 (6%)

Un-related Mortality 1 1 2 (3%)

Type I-III Endoleak - - - 13 (19%)

Open Conversion 0 0 0 0

Ischemic stroke 0 1 1 2 (3%)

Permanent SCI 0 1 0 1 (1.5%)

Temporary SCI 5* 4* 1* 7* (11%)

Respiratory failure 2 5 1 8 (12%)

Cardiac failure 1 3* 0 4 (6%)

Renal Injury / failure 0 3 0 3 (5%)

30-day resultsAny systemic complication (grade > 2): 10 (19%)

Grade > 2 SVS reporting standards*same patients

Intersurgical rupture in the CMD waiting time (1 case)

Patient Preop. risk factors 1st Step 2st Step 3rd Step 6-month Outcome

#2 P.C.Thoracic open repairAbdominal open repairRight vertebral artery

Tarlov 3Delayed (2 day)

CSFD – Immediate recovery0 0 Tarlov 5

# 11 G.F.Thoracic open repairAbdominal open repair

Tarlov 2Delayed (9 days)

No CSFD0

Tarlov 3Delayed (2 days)

CSFD preop. insertedTarlov 5

# 17 G.I.TAAA open repairLeft subclavian artery stenosis

0Tarlov 2

Delayed (3 days)CSFD – progressive recovery

0 Tarlov 5

#34 D.G. Left vertebral artery occlusion Tarlov 3

Delayed (2 days) no CSFD - controindicated

Tarlov 1 Immediate

No recovery

Not performedRelated death

Related death

# 43 D.M.Previous EVAR Left internal iliac occlusion

Tarlov 1 Immediate

CSFD – Immediate recovery

Not performedUn-related death

Not performedUn-related death

Un-related Death

# 55 B.R Previous open AAA 0Tarlov 4

ImmediateNo CSFD -controindicated

0 Tarlov 5

# 56 D.G.Previous open AAAPrevious EVAR 0

Tarlov 3Delayed (3 days)

No CSFD -controindicated0 Tarlov 5

# 57 G.C.Previous TEVARPrevious open AAARight hypogastric occlusion

0

Tarlov 4Delayed (2 days)

No CSFD -controindicated0 Tarlov 5

Spinal cord ischemia details10 any grade SCI events in 8 patients (11.9%)

75% delayed

2 immediate recovery2 recovery within 1 month

60% delayed

1 immediate recovery3 recovery within 1 month

1 Permanent SCI

100% delayed

1 recovery within 1 month

1 permanent and fatal SCI

50% previous thoracic repair63% previous open repair38% vertebral impairment

25% hypogastric impairment

75% at least two territories

Discussion

Different visceral staging optionsPROs and CONs?

a. One branch open

b. Perfusion branches

c. All branch open

d. MISACE

e. Contralateral limb open

Kasprzak et al. Eur J Vasc Endovasc Surg 2014

Harrison SC et al. J Vasc Surg 2012

No series

ESVS submitted 2018

Branzan D et al. EuroIntervention 2018

Different authors

Why a third limb stage?PROs

- Final exclusion of the aneurysm in stable condition (15 min. of procedure under local anesthesia)

- No redo upper extremities access (no stroke risk)

- High flow type IB endoelak rather that IA with no exit

- Anyone can do it, in any hospital if the patient become symptomatic or rupture

Why a third limb stage?PROs

- Final exclusion of the aneurysm in stable condition (15 min. of procedure under local anesthesia)

- No redo upper extremities access (no stroke risk)

- High flow type IB endoelak rather that IA with no exit

- Anyone can do it, in any hospital if the patient become symptomatic or rupture

Open limbHigh flow Type IB EL

Why a third limb stage?PROs

- Final exclusion of the aneurysm in stable condition (15 min. of procedure under local anesthesia)

- No redo upper extremities access (no stroke risk)

- High flow type IB endoelak rather that IA with no exit

- Anyone can do it, in any hospital if the patient become symptomatic or rupture

OSR discharge summary

Conclusions

- Tailor the procedure according to patients’ anatomy

- Reduce the invasiveness and risk of permanent SC ischemia

- Open limb strategy: easy, safe and feasible

Multistaged approach

Post-dissecting TAAA

Systematic multi-staged endovascular repair of

thoracoabdominal aneurysms with fenestrated and branched endografts (STEAR study)

Loschi Diletta

Vascular Surgery, “Vita-Salute” - San Raffaele UniversityScientific Institute Ospedale San Raffaele, Milan – Italy

Chief: Prof. R. Chiesa