Systematic multi-staged endovascular repair of ... · endovascular repair of thoracoabdominal...
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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
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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
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San Raffaele STaged Endovascular Repair protocolProgressive thrombosis of intercostal and lumbar arteries
Thoracic step Visceral step Limb stepType II TAAA
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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
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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)
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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
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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
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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
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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
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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)
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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
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Discussion
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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
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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
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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
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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
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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
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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