The Petticoat Technique Managing Type B Dissection with both Early and Long Term Considerations

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1 The Petticoat Technique Managing Type B Dissection with both Early and Long Term Considerations Joseph V. Lombardi, MD Professor & Chief, Division of Vascular & Endovascular Surgery Department of Surgery, Cooper University Hospital Cooper Medical School of Rowan University 1

2 Disclosure Statement of Financial Interest Grant/Research Support Consulting Fees/Honoraria CookMedical Covidien Gore CookMedical

3 Case Presentation Acute Complicated TBAD 53 y/o with Tearing back pain X 4hours Severe HTN Renal failure Lower extremity ischemia

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7 Courtesy of Terry Devine, Melbourne Australia Investigational device, limited by federal (U.S.A.) law to investigational use

8 Courtesy of Terry Devine, Melbourne Australia Investigational device, limited by federal (U.S.A.) law to investigational use

9 Investigational device, limited by federal (U.S.A.) law to investigational use

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11 Investigational device, limited by federal (U.S.A.) law to investigational use

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15 Bare Metal Stent Properties: Re-approximates delaminated intima Alleviate persistent Dynamic obstruction Reduces False lumen volume Expands True lumen volume Favorably positions pt for future intervention

16 Composite Device Design Complicated Dissection STABLE I Completed enrollment 86 pts 3 year data available Real world data STABLE II Enrollment Completed Device modification TX2: no proximal barbs Nitinol bare metal stent Enrollment eligibilty Malperfusion Rupture Acute (< 14 days)

17 Composite System Zenith TX2 Endovascular Graft Caution - Investigational device. Limited by Federal (or United States) law to investigational use. Zenith Dissection Endovascular Stent 17

18 STABLE I 2 Year follow-up 30 day mortality: 4.7% All cause mortality: 15% Positive aortic remodeling Acute phase treatment: Higher rate of: Stroke Retrograde dissection Aortic growth

19 STABLE I Study - Patients 86 patients (73% male; mean age 59 years) Type B aortic dissections warranting surgical intervention or not responding well to medical management All treated within 90 days of symptom onset Phase treated % (n/n) Mean time to treatment, days Acute (0-14 days) 64% (55/86) 4.2 ± 3.7 (0-14) Non-acute (15-90 days) 36% (31/86) 40.5 ± 22.5 (15-86) 19

20 STABLE I Study - Dissections Complicated Type B aortic dissections Inclusion criteria Acute, % (n/n) N = 55 Non-acute, % (n/n) N = 31 P value Branch vessel obstruction/compromise 69% (38/55) 58% (18/31).35 Peri-aortic effusion/hematoma 20% (11/55) 10% (3/31).36 Resistant hypertension 55% (30/55) 55% (17/31) >.99 Persistent pain/symptoms 82% (45/55) 65% (20/31).12 Transaortic growth 5 mm within 3 months (or transaortic diameter 40 mm) 35% (19/55) 74% (23/31) <.001 Dissection was extensive in most patients Extending below the diaphragm in 99% In or below common iliac arteries in 77% 20

21 STABLE I Study - Devices TX2 TXD Dissection stent was placed in 93% of patients (6 patients did not receive a dissection stent at physician s discretion) A majority of patients received only 1 TX2 component (79%) Successful device deployment in all patients, with 100% patency 21

22 Mortality Within 30 Days 30-day mortality Acute dissection: 5.5% (3/55) Non-acute dissection: 3.2% (1/31) Overall group: 4.7% (4/86) Patient Days to death Cause of death Acute 5 Stroke Related Acute 11 Stroke Related Acute 11 Aortic rupture Related CEC adjudication of relationship to dissection repair Non-acute 29 Unknown Unable to determine 22

23 Acute Dissection: 30-Day Results Comparison to Literature 30-Day Event STABLE I Acute (N = 55) White 2011 Pooled SVS dataset Acute, complicated (N = 85) Fattori 2013 Pooled results on TEVAR Acute (N = 2,359) Mortality 5.5% (3/55) 10.6% (9/85) Stroke 10.9% (6/55) 9.4% (8/85) 10.2% 30-day or in-hospital mortality 4.9% 30-day or in-hospital stroke Paraplegia 1.8% (1/55) 9.4% (8/85) Paralysis/paraparesis 4.2% 30-day or in-hospital spinal cord ischemia Bowel ischemia 1.8% (1/55) 3.5% (3/85) Not reported Renal failure 10.9% (6/55) 9.4% (8/85) Not reported White et al. J Vasc Surg. 2011;53: Fattori et al. J Am Coll Cardiol. 2013;61:

24 Non-Acute Dissection: 30-Day Results Comparison to Literature 30-Day Event STABLE I Non-acute (15-90 days, N = 31) White 2011 Pooled SVS dataset Sub-acute/chronic (15-90 days, N = 14) Fattori 2013 Pooled results on TEVAR Chronic (>60 days, N = 1,098) Mortality 3.2% (1/31) 7.1% (1/14) Stroke 0% (0/31) 0% (0/14) 6.6% 30-day or in-hospital mortality 1.9% 30-day or in-hospital stroke Paraplegia 0% (0/31) Bowel ischemia 0% (0/14) Paralysis/paraparesis 1.5% 30-day or in-hospital spinal cord ischemia 0% (0/31) 0% (0/14) Not reported Renal failure 3.2% (1/31) 0% (0/14) Not reported White et al. J Vasc Surg. 2011;53: Fattori et al. J Am Coll Cardiol. 2013;61:

25 Aortic Remodeling Pre-procedure 24-month 48-month 48-month 25

26 False Lumen Thrombosis Descending thoracic aorta (down to the celiac artery) Complete thrombosis Pre-op 1-year 3-year Acute dissection: 0% 38% 53% Non-acute dissection: 0% 25% 40% No patent false lumen at 6 months and beyond Abdominal aorta Complete thrombosis Pre-op 1-year 3-year Acute dissection: 1.8% 12% 9.7% Non-acute dissection: 0% 4.2% 20% Patent false lumen: 58% (pre-procedure) to 4.3% (3 years) 26

27 Remodeling - Descending Thoracic Aorta Acute dissections (N = 55) Non-acute dissections (N = 31) Significant true lumen expansion and false lumen compression 27

28 Remodeling Abdominal Aorta Estimated changes in the true and false lumen diameters Acute dissections (N = 55) Non-acute dissections (N = 31) 28

29 Growth of Aorta Definition: Increase >5mm in the transaortic diameter compared to post-procedure (or 1-month if post-procedure measurement was not available) Largest diameter Time Acute Non-acute Descending thoracic aorta, % (n/n*) 1-year 29% (12/41) 4.0% (1/25) 2-year 37% (14/38) 14% (3/21) 3-year 29% (9/31) 13% (2/15) Largest diameter Time Acute Non-acute Abdominal aorta, % (n/n*) 1-year 29% (12/42) 8.0% (2/25) 2-year 51% (19/37) 9.5% (2/21) 3-year 47% (15/32) n/a *Number of patients with available CT images (with adequate quality) analyzed by the core laboratory 29

30 Aortic Growth after TEVAR Study Resch 2006 Sobocinski 2013 Fattori 2013 IRAD registry Dissections N = 74 (mixed acute and chronic) TEVAR (stent-graft alone) N = 52 (all acute) TEVAR (stent-graft alone) N = 276 (all acute) TEVAR Thoracic Aorta (> 5mm increase) Abdominal Aorta (> 5mm increase) 14% Not reported 25% at 1 year 33% at 12 months 28% at 1 year 33% at 2 years 63% at 5 years Lombardi 2013 STABLE Trial N = 86 acute and chronic TEVAR / Petticoat 29% at 1 year 37% at 2 years 29% at 3 years 29% at 1 year 51% at 2 years 47% at 3 years Brunkwall Adsorb trial 2014 N = 30 (acute uncomplicated) 1 year Not reported Resch et al. J Cardiovasc Surg (Torino). 2006;47: Sobocinski et al. Eur J Vasc Endovasc Surg. 2013;45:

31 Secondary Interventions Within 3 years in overall patient group: 29 secondary interventions in 23 patients: Persistent entry-flow or sealing of re-entry tear, n = 13 Malperfusion or ischemia, n = 5 Type A or retrograde dissection, n = 5 Aneurysm growth or degeneration, n = 5 Device migration, separation, or kink, n = 4 Aortic rupture, n = 2 31

32 Persistent False Lumen flow Patients treated ACUTE Setting % Future Growth Re-entry tears: Iliac Renal Celiac Management? Re-entry tear exclusion False lumen embolization

33 Adjunctive Stent Placement & Direct False Lumen Embolization

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45 Conclusions Low 30-day mortality and paraplegia rates for petticoat technique using the Zenith dissection system. Aortic remodeling was observed within and beyond the stent-grafted segment, in both acute and non-acute dissections There exists a risk of aortic dilation, especially in dissections treated in the acute phase Management of ctabd is a long-term commitment 45