Going the distance: Conformable Gore TAG device demonstrates durable outcomes over the long D.Böckler University Hospital Heidelberg, Germany
Disclosures Speaker name: Dittmar Böckler I have the following potential conflicts of interest to report: Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Research Grant I do not have any potential conflict of interest
Launch: October 2009 100.000 Implants worldwide
Concept of CTAG FDA-approved to treat various thoracic aortic pathologies
Concept: Device Modifications Design Size - Configurations
Concept - Oversizing windows for different pathologies Aortic diameter 31mm: TAG 34 mm Aortic diameter 31mm: CTAG 34 / 37 / 40mm CTAG - engineered for 6-33% oversizing conditions IMH with 31 mm > CTAG 34 mm = 10 % Oversizing TAA with 31 mm > CTAG 37 mm = 20 % Ovversizing
4-5 Years Results with CTAG (mean 2 yrs.) Prospective Multicentre Regulatory US- Study 1 Prospective Multicentre Europen Registry 2 GREAT Registry unpublished Single Center Experience 2 Heidelberg Experience (407 devices/163 pat.) unpublished HUMAN STUDY eissn 2325-4416 Med Sci Monit Basic Res, 2015; 21: 262-270 DOI: 10.12659/MSMBR.897010 Received: Accepted: Published: Device Conformabilit y and Morphological Assessment Af t er TEVAR for Aortic Type B Dissect ion: A Single-Cent re Experience with a Conformable Thoracic Stent-Graf t Design 2015.12.07 2015.12.20 2015.12.31 Authors Contribution: Study Design A Data Collection B Statistical Analysis C Data Interpretation D Manuscript Preparation E Literature Search F Funds Collection G ABCDEF 1 BCD 2 BEF 1 EF 1 ACDE 1 Corresponding Author: Source of support: Background: Material/Methods: Results: 1Jordan Moritz S. Bischoff Matthias Müller-Eschner Katrin Meisenbacher Andreas S. Peters Dittmar Böckler 1 Department of Vascular and Endovascular Surgery, Heidelberg University Hospital, Heidelberg, Germany 2 Department of Radiodiagnostics and Interventional Radiology, Heidelberg University Hospital, Heidelberg, Germany Dittmar Böckler, e-mail: dittmar.boeckler@med.uni-heidelberg.de Departmental sources The aim of this study was to analyze device conformability in TEVARof acute and chronic (a/c) type B aortic dissections (TBAD) using the Gore Conformab le Thoracic Aortic Stent-graft (CTAG). From January 1997 to February 2014, a total of 90 out of 405 patients in our center received TEVARfor TBAD. Since November 2009, 23 patients (16 men; median age: 62 years) were treated with the CTAG. Indications were complicated atbad in 15 (65%) and expanding ctbad in 8 (35%) patients. Primary endpoints were the assessment of device conformability by measuring the distance (D) from the radiopaque gold band marker (GM) at the proximal CTAG end to the inner curvature (IC) of the arch on parasagittal multiplanar reformations of CT angiography, as well as the evaluation of aortic diameter changes following TEVAR. Median follow-up was 13.3 months (range: 2 days to 35 months). Primary and secondary success rates were 91.3%(21/23) and 95.6%(22/23), respectively. There was 1 type Ia endoleak, retrograde dissection or primary conversion was not observed. Median GM-IC-D was 0 mm (range: 0 mm to 10 mm). GM-IC-Dwas associated with zone 2 placement compared to zone 3 (P=0.036). There was no association between GM-IC-D formation and arch type. In atbad cases the true lumen significantly increased after TEVAR(P=0.017) and the false lumen underwent shrinkage (P=0.025). In ctbad patients the false lumen decreased after TEVAR(P=0.036). The CTAGshows favorable conformability and wall apposition in challenging arch pathologies such as TBAD., JVS 2015, 2Böckler EJVES 2016, 3 Bischoff Med Sci Research 2015, 3Böckler,Endovascular Today 2014 Conclusions: MeSH Keywords: Aneurysm, Dissecting Cardiovascular Diseases Endovascular Procedures
CTAG 08-03 Aneurysm Study (USA) 1 Jordan W et al., JVS 2015:61:589-95 8 sites: 66 patients all aneurysms (DTAA) Oct 2009- Sept. 2011 30 d results: Mortality 1.5 % Any SAE 23 % Paraplegia 2 % Stroke 2 % 2 yrs. results Type Ia Endoleak 3.2 % TAA rupture 0 % 5 mm decrease 86%
Aneurysm Related Survival: 97% (n=2) 1 rupture of ascending aneurysm 1 arterial access rupture for secondary intervention both separate from procedure 1 Jordan W et al., JVS 2015:61:589-95
European Prospective CTAG Registry 5 sites: 100 patients 56 TAA, 32 B-Diss., 4 Trauma 30 day Results Technical success 92 % Mortality 3.3% Complication rate 34 % Stroke rate 11% 2 yr. Results Overall survival 74% - Elective 80% - Emergency 62% Böckler, Brunkwall, Taylor, Mangilardi, Larzon EJVES. 2016;51: 791-800
Technical Results Device deployment 100 % Accuracy deployment 99 % Conformability 95 % Böckler, Brunkwall, Taylor, Mangilardi, Larzon EJVES. 2016;51: 791-800
Predicting Risk Factors for Death and SAE Böckler, Brunkwall, Taylor, Mangilardi, Larzon EJVES. 2016;51: 791-800
GREAT - Real World Registry
GREAT - Real World Registry
GREAT - Real World Registry (n=133 through 2 years follow up) 2 Type Ia endoleaks 4 Type Ib endoleaks 2 type II endoleaks 1 migration 3% device related re-intervention through 2 yr. FU 8% death rate though 2 year follow up
Device Conformability HUMAN STUDY eissn 2325-4416 Med Sci Monit Basic Res, 2015; 21: 262-270 DOI: 10.12659/MSMBR.897010 2.07 2.20 2.31 Device Conformability and Morphological Assessment After TEVAR for Aortic Type B Dissection: A Single-Centre Experience with a Conformable Thoracic Stent-Graft Design n: A B C D E F G ABCDEF 1 BCD 2 BEF 1 EF 1 ACDE 1 nding Author: Moritz S. Bischoff Matthias Müller-Eschner Katrin Meisenbacher Andreas S. Peters Dittmar Böckler Dittmar Böckler, e-mail: dittmar.boeckler@med.uni-heidelberg.de 1 Department of Vascular and Endovascular Surgery, Heidelberg University Hospital, Heidelberg, Germany 2 Department of Radiodiagnostics and Interventional Radiology, Heidelberg University Hospital, Heidelberg, Germany Apposition to inner wall 100% N = 1 (5,0%) N = 13 (65,0%) N = 6 (30,0%) No association between apposition and arch type 21/23) and 95.6% (22/23), respectively. There was 1 type Ia endoleak, retrograde dissection or primary conversion was not observed. Median GM-IC-D was 0 mm (range: 0 mm to 10 mm). GM-IC-D was associated with zone 2 placement compared to zone 3 (P=0.036). There was no association between GM-IC-D formation and arch type. In atbad cases the true lumen significantly increased after TEVAR (P=0.017) and the false lumen underwent shrinkage (P=0.025). In ctbad patients the false lumen decreased after TEVAR(P=0.036). Conclusions: The CTAG shows favorable conformability and wall in challenging arch pathologies such as TBAD. Less apposition in LZ 2 versus 3 (p=0.03) Keywords: Aneurysm, Dissecting Cardiovascular Diseases Endovascular Procedures ull-text PDF: http://www.basic.medscimonit.com/abstract/index/idart/897010 2872 5 2 34 3 BischofffM, Blckler D, Med Sci Research 2015,
TEVAR Heidelberg (n=487) March 1997 Oct 2016 Total elektiv Notfall Thoracic aortic aneurysm (TAA) 80 61 (76.3) 19 (23.7) Sept. 2010 Sept. 2016 Ruptured TAA 30-30 (100.0) Thoracoabdominal aneurysm 74 50 (67.5 24 (33.5) 163 patients (male 58%, mean age 66 yrs.) Penetrating aortic ulcer (PAU) 65 32 (49.2) 33 (60.8) Traumatic aortic rupture 26-26 (100.0) Chronic Typ B dissection 49 36 (71.4) 13 (28.6) 407 CTAG devices (verage 2.5 / patients) Acute Typ B dissection 45 13 (28.8) 32 (71.2) Intramural haematoma (IMH) 26 14 (53.8) 12 (46.2) Mean 2.5 devices p.p. Type A dissection 5 1 (20.0) 4 (80.0) Aortobronchial fistula 7 1 (14.3) 6 (85.7) Ruptured Patch-aneurysm 3 1 (33.3) 2 (66.7) 83 % Arch involvment (Zone 0-3) Patch-aneurysm 7 5 (71.4) 2 (28.6) Anastomotic aneurysm 7 5 (85.7) 2 (14.3)
Indications for TEVAR with CTAG Sept. 2010 Sept. 2016 Indication N Acute type B-Dissection 35 PAU 27 TAA* 19 TAAA 18 IMH 17 Traumatic rupture 10 CEAD** 10 rtaa 7 ABF 5 Anastomotic 5 Aneurysm Acute Type A Dissection 3 Posttraumatic TAA 2 Patchaneurysm 2 Patchrupture 1 Corpus alienum 1 (Palakossporn) Symptomatic Aortic Thrombus 1
Heidelberg Single Center 6 yr Experience 30 day Results: Technical success 97,5 % Mortality 3.3% Follow up Results: Reintervention rate 21 % Overall mortality (43/166) 26 % Aortic related mortality 8/166) 5 %
Advantages - Personal Opinion Oversizing windows for each pathology Unsheated device very flexible for arch and tortous anatomy easy access for multiple devices Highly confomable in the arch Fast or slow deployment 1 Jordan, JVS 2015, 2 Böckler EJVES 2016, 3 Bischoff Med Sci Research 2015, 3 Böckler,Endovascular Today 2014
Example of Complex Arch Morphology
Future Refinements of the CTAG Branched technology Steering delivery system to enhance control and vessel wall Partial deployment Partial deployment All products are under development and not available or approved for sale in any market.
Conclusions Concept is proven in the long run Modifications of CTAG increased conformability CTAG shows very favorable results at mean 2 years No device failures, low major device events CTAG is our prefered device for aortic arch pathologies Continued FU over the next 5 yrs. will be important
Going the distance: Conformable Gore TAG device demonstrates durable outcomes over the long D.Böckler University Hospital Heidelberg, Germany