Total aortic arch replacement with Thoraflex hybrid prosthesis Malakh Shrestha Div. of Cardio-thoracic, Transplantation and Vascular Surgery Hannover Medical school
Total aortic arch replacement withThoraflex hybrid prosthesis
Malakh Shrestha
Div. of Cardio-thoracic, Transplantation and Vascular SurgeryHannover Medical school
Cardio-Thoracic,Transplantation and Vascular Surgery
1. Adequate Cerebral/ Organ protection
(minimize PND, TND,Myocardial infarction)
(Do not forget the Intestines, Kidneys & other organs!!)
2. Pathology related extension of surgery
3. Haemostasis
Goals in aortic arch operations
Cardio-Thoracic,Transplantation and Vascular Surgery
40mm30mm
Brain
Bone
Cardioplegia line
INVOS® Somanetics, Troy, MI, USAINVOS® Somanetics, Troy, MI, USA
Cardio-Thoracic,Transplantation and Vascular Surgery
Strategies for treatment of combined Disease of the aortic arch
& descending aorta
• Two Stage
• Elephant Trunk procedure
• Single Stage
(Clam-shell, Sternotomy+ Thoracotomy)
New techniques:
• Frozen Elephant Trunk (Hybrid)
• Aortic debranching + Endo-vascular Stenting
Total aortic arch replacement remains a surgical challenge!
Cardio-Thoracic,Transplantation and Vascular Surgery
Core temperature 24-26°C
Cold selective antegrade cerebral perfusion (22-24°C)Innominate + left carotid arteryContinous infrared spectroscopy
Topical cooling (head in ice)High dose methylprednisolone
Lower Body Perfusion (2-3 ltr/ min)
Minimize Myocardial ischaemia time: (distal anastomosis first followed by & proximal anstomosis, supra-aortic
anastomoses at end)
Novel hybrid Graft
Hannover Cerebral/ Organ Protection Concept
Cardio-Thoracic,Transplantation and Vascular Surgery
1. Adequate Cerebral/organ protection
2. Pathology related extension of surgery
3. Haemostasis
Goals in aortic arch operations
Cardio-Thoracic,Transplantation and Vascular Surgery
Stage 1
Stage 2
Borst HG et al. Extensive aortic replacement using the ‚elephant trunk prosthesis‘
Thorac Cardiovasc Surg 1983; 31 (1): 37-40
Endovascular completionSurgical completion
ET procedure for treatment of combined disease of the aortic arch & descending aorta
Cardio-Thoracic,Transplantation and Vascular Surgery
Aortic Arch “Debranching“ (Less Invasive?)
• Reliance on extra-anatomic bypass patency
• -The amount of real estate gained is not that great
– Relatively short, not parallel unless into ascending prosthetic graft
• Distal Arch Re-routing
– Double transposition of the subclavian artery to the left common carotid artery
and of the left common carotid artery to the innominate artery
• Total Arch Re-routing
-Reversed bifurcated prosthesis from the ascending aorta to the innominate & left commoncarotid arteries
• What about the Radiation effects?.
Cardio-Thoracic,Transplantation and Vascular Surgery
TEVAR in Aortic Arch:Technical Difficulties
• presence of Supra-aotic vessels: where is the ‘landing Zone‘ ?
-Necessity for ‘Debranching‘
•Anatomic & hemodynamic specialities of the aortic arch:
-Curvature (almost 270°)
-High blood flow velocity
-Substantial movement of this portion of of aorta with every Heart-beat
unlike other segments of aorta
Side biting clamps on diseased ascending aorta
Emboli, Retrograde dissection: ? Stroke
Cardio-Thoracic,Transplantation and Vascular Surgery
Cardio-Thoracic,Transplantation and Vascular Surgery
FET ProcedureThe Frozen elephant trunk technique uses a stented section
of graft. This potentially allows the procedure to be carried
out in one stage, dependant on the length of affected vessel.
Dake et al. The‚ first generation‘ of endovascular stent grafts for patients with aneurysms of
the descending aorta. JTCVS 1998
Usui et al. Clinical results of implantation of an endovascular covered stent graft via
midsternotomy for distal aortic arch aneursyms. Cardiovasc Surg 2000.
Karck et al. The frozen elephant trunk technique: a new treatment for thoracic aortic
aneurysms. JTCVS 2003
Cardio-Thoracic,Transplantation and Vascular Surgery
• Aneurysms of the aortic arch and the descending aorta
• Initially limited to pts. with extended pathology of the first half of the descending
aorta.
• Normal aortic diameter below the ‘Landing Zone‘ (for single stage treatment)
• Dissections (chronic, acute )
Indications
DeBakeyStanford
IA
IIA
IIIB
Cardio-Thoracic,Transplantation and Vascular Surgery
J Cardiovasc Surg (Torino). 2011 Oct;52(5):717-23.
The International E-vita Open Registry: data sets of 274 patients.
Jakob H, Tsagakis K, Pacini D, Di Bartolomeo R, Grabenwoger M, Mestres C, Mohr F, Bonser R, Cerny S, Oberwalder P.
AIM:
After the introduction of the hybrid stent-graft "E-vita-open" by the Essen group in 1/2005 for one stage repair of complex thoracic aortic disease, the International E-vita open Registry was founded in 2008 to study the principles of this treatment algorithm and to control reported favorable single center results on a large patient data set basis up to six years after the first clinical implant.
METHODS:
Retrospective data work-up after prospective data acquisition was achieved by institution of the International E-vita open Registry with anonymous registration and calculation at Essen University Hospital. From January 2005 to December 2010, 274 patients (mean age 60; 74% males) with complex aortic disease, 190 with aortic dissection (88 acute (AAD), 102 chronic aortic dissection (CAD), and 84 with complex thoracic aortic aneurysm (TAA) were included in the studied.
RESULTS:
Eighty-one out of 274 (30%) patients underwent emergency surgery. Stent-graft deployment and arch replacement (238 total, 36 subtotal) was performed under selective antegrade cerebral perfusion (75 min mean). Cardiopulmonary bypass (CPB) and cardiac arrest times were mean 235 and 134 minutes, respectively. In-hospital mortality was 15% (40/274), 18% for AAD, 13% for CAD, and 14% for TAA. New strokes were observed in 6% (16/274), spinal cord injury in 8% (22/274). The false lumen (FL) was evaluated throughout the first hospital stay and at a median follow up time of 59 months after surgery. From the first follow up CT-examination to the last, thoracic complete FL thrombosis increased from 83% to 93% in AAD, from 72% to 92% in CAD. Full exclusion of the aneurysmal disease was achieved in 77% (61/79) during the primary hospital stay.
CONCLUSION:
Favorable single center results could be confirmed by an International community of
cardiac surgical centers in regard to hospital mortality and morbidity, as well as a low
postoperative complication rate and exclusion of false lumen in aortic dissection.
Cardio-Thoracic,Transplantation and Vascular Surgery
Early Frozen ETs: lot of improvisations
Cardio-Thoracic,Transplantation and Vascular Surgery
Custom made FET: Haverich- Chavan
Jotec E-vita
Cardio-Thoracic,Transplantation and Vascular Surgery
Proposed advantages of 4-finger (Plexus) graft for
aortic arch vessel re-implantation
1. Reduction of myocardial and lower body ischaemia
2. Reduction of subclavian artery ischaemia
3. Pathological (potentially) regions of the aortic arch can be totally resected (eg. Marfan Pts)
4. Anstomoses can be to supraaortic vessels where dissection has not extended to.
5. Hemostasis is easier at the individual arch vessel anastomoses.
6. Atheromatous regions of the arch or the beginnings of the arch vessels can be completely resected.
Cardio-Thoracic,Transplantation and Vascular Surgery
Ann Thorac Surg. 2004 Jun;77(6):2021-8.
Separate grafts or en bloc anastomosis for arch vessels reimplantation to the aortic arch.
Di Eusanio M, Schepens MA, Morshuis WJ, Dossche KM, Kazui T, Ohkura K, Washiyama N, Di Bartolomeo R, Pacini D,
Pierangeli A.
BACKGROUND:
This study compares the results of the separated graft technique and the en bloc technique as a method of arch vessels
reimplantation during surgery of the aortic arch and determines the predictive risk factors associated with hospital mortality and
adverse neurologic outcome during aortic arch repair.
METHODS:
Between October 1995 and March 2002, 352 patients (mean age 64.9 +/- 11.3 years; urgent status: 49/352 [13.9%]) underwent
surgery of the aortic arch using the separated graft technique (group A: n = 230 [65.3%]) and the en bloc technique (group B: n
= 122 [34.7%]) to reimplant the arch vessels. The mean cardiopulmonary bypass time was 204.8 +/- 61.9 minutes (group A:
199.7 +/- 57.0 minutes; group B: 214.5 +/- 69.4 minutes; p = 0.033), the mean myocardial ischemic time was 121.5 +/- 43.2
minutes (group A: 116.7 +/- 38.9 minutes; group B: 130.80 +/- 49.4 minutes; p = 0.003), and the mean antegrade selective
cerebral perfusion time was 84.5 +/- 36.4 (group A: separated graft technique 91.3 +/- 36.3 minutes; group B: 70.6 +/- 32.7
minutes; p = 0.000).
RESULTS:
Overall hospital mortality was 6.8% (group A: 6.5%; group B: 7.4%; p = not significant [NS]). The permanent neurologic
dysfunction rate was 3.5% (group A: 4.0%; group B: 2.5%; p = NS). The transient neurologic dysfunction rate was 5.4% (group
A: 5.5%; group B: 5.2%, p = NS). Postoperative systemic morbidity was similar in the two groups.
CONCLUSIONS:
The separated graft technique had no adverse impact on hospital mortality and morbidity.
Cardio-Thoracic,Transplantation and Vascular Surgery
1. Adequate Cerebral/organ protection
2. Pathology related extension of surgery
3. Haemostasis
Goals in aortic arch operations
Cardio-Thoracic,Transplantation and Vascular Surgery
Shimamura et al 2009
Homemade devices
Cardio-Thoracic,Transplantation and Vascular Surgery
Vascutek Hybrid graft
• Device consists of a unstented proximal part with Dacron & a stenteddistal part made of polyester and nitinol stent
• Un-stented dacropart has 4 ‘fingers’, three for the supra-aortic vessels & one for the arterial cannulation.
• The length of the stented part: 10 & 15 cms.
• The proximal unstented & distal stented parts are available in different sizes
• a sewing collar simplifies the suturing of distal anastomosis.
• Radio-opaque markers in the stented part.
Fully Sealed Device
• Removes need for in situ sealing and suturing together of two devices
• Faster Procedure
Product Development Collaboration
• Hannover Medical School, Germany
Cardio-Thoracic,Transplantation and Vascular Surgery
Splitter•Provides rotational and axial
attachment of device to delivery
system
•Splits the sheath during retraction
Tip•Provides side guide wire
access
Release Clip•Attachment to release wire
Handle•User Interface
Plexus Graft
Splittable Sheath•Completely removed from system
after deployment
Strap•User interface
•Attachment to sheath
Vascutek Thoraflex: Delivery System
Malleable St/St Shaft•Provides adequate stiffness during
deployment
•Allow the surgeon to pre-curve the delivery
system for particular anatomy
Cardio-Thoracic,Transplantation and Vascular Surgery
Vascutek Thoraflex Hybrid Graft
Collar
Simplifies distal anastamosis
Fully Sealed Device
Endograft
Added Stability Columnar Integrity
Plexus 4 Branch Gelweave graft
Radiopaque Markers
Visibility of stented section
Cardio-Thoracic,Transplantation and Vascular Surgery
Cardio-Thoracic,Transplantation and Vascular Surgery
Cardio-Thoracic,Transplantation and Vascular Surgery
Cardio-Thoracic,Transplantation and Vascular Surgery
a
b
Jotec E-vita
Haverich Chavan (Custom made)
Vascutek Thoraflex
Cardio-Thoracic,Transplantation and Vascular Surgery
Pre-operative Data Total Haverich-Chavan Jotec E-vita Vascutek Thoraflex
Total Patients (n) n= 131 n= 66 n=30 n=35
Sex (Male/Female) Male:95, Female:36 Male:47, Female:19 Male :24,Female:6 Male:24, Female:11
Age (Years) 61± 13 61 ± 13 61 ± 12 61 ± 13
Marfan Syndrome (n,%) n=12 (9%) n=9 (14%) n=2 (7%) n=1 (3%)
Mega aortic syndrome (n,%) n=15 (11%) n=3 (5%) n=4 ( 13%) n=8 (23%)
Degenerative aneurysm (n,%) n=40 (3%) n= 19 (30%) n=10 (33%) n=11 (31%)
Acute aortic dissection (n,%) n=48 (37%) n=17 (26%) n=14 (47%) n=16 (46%)
AADA (n,%) n=45 (34%) n=14 (21%) n=14 (47%) n=16 (46%)
AADB (n,%) n=3 (2%) n=3 (5%) n=0 n=0
Chronic aortic dissection n=43 (33%) n=29 (44%) n=6(20%) n=8 (23%)
Chr. Aortic dissection :type A n=33 (25%) n=21 (32%) n=4 (13%) n=8 (23%)
Chr. Aortic dissection :type B n=10 (8%) n=8 (12%) n=2 (7%) n=0
Hanover Medical School FET: (Pre-operative patient data; 8/2001 to 1/2012)
Total aortic arch replacement with FET: 10 year single centre experience
Cardio-Thoracic,Transplantation and Vascular Surgery
• Vascutek paper
Cardio-Thoracic,Transplantation and Vascular Surgery
• Aortic arch surgery is a technical challenge and should be done in experienced centres.
• Gold Standard for aortic arch pathology treatment remains the conventional open repair (no Ia endo-
leaks)
• The FET procedure allows a one stage repair.
- If necessary, it offers a secure landing zone for additional endovascular procedures.
-Second stage operations are generally possible.
• Hybrid procedures (with TEVAR):
- Enable aortic arch treatment without the use of CPB and HCA,
- as of now only in patients unfit for conventional surgery and “special cases“
Cost of treatment should also be a factor!
Every center has to take into account their expertise & results in deciding which technique to use.
Tailoring the operation based upon a patients individual needs and anatomical considerations is
crucial.
Conclusions I
Cardio-Thoracic,Transplantation and Vascular Surgery
Hybrid 4-Finger Dacron graft (Plexus™) prosthesis
1. The Gel-coat ensures classical hemostatic properties combined with excellent handling.
2. Unique features of the graft (different sizes of the unstented & stented parts as well as a
sewing collar) simplifies the surgical procedure.
3. Branched grafts facilitate active hemostasis and potentially reduces ischaemia times
(myocardial, and lower body) while allowing for highest degree of flexibility during
procedure.
4. Ringstent design allows for excellent anatomical conformity to the descending aorta.
Conclusions II