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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
✓
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