Hybrid Aortic Arch Debranching With Staged Endovascular Completion in DeBakey Type I Aortic Dissection

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1 Hybrid Aortic Arch Debranching With Staged Endovascular Completion in DeBakey Type I Aortic Dissection Antonino G.M. Marullo, MD, PhD, Samuele Bichi, MD, Rocco A. Pennetta, MD, Gerardo Di Matteo, MD, Antonio M. Cricco, MD, Luigi Specchia, MD, Fausto Castriota, MD, and Giampiero Esposito, MD Department of Cardiovascular Disease, Città di Lecce Hospital, GVM Research and Care, Strada Provinciale per Arnesano, Lecce, Department of Surgery and Bioengineering, Unit of Cardiac Surgery, University of Siena, Siena, Italy Background. We assess midterm results of a hybrid approach to DeBakey type I aortic dissection using a new multibranched Dacron graft to create, by relocation of the inflow openings to the arch vessels toward the aortic root, a new aortic arch for an easier and safer second-staged endovascular stent grafting of the distal thoracic aorta. Methods. From March 2006 to July patients with DeBakey type I aortic dissection underwent ascending aorta and aortic arch replacement with debranching of epiaortic vessels using a new prosthesis to create an optimal landing zone for possible subsequent endovascular stent grafting of the distal thoracic aorta. Fifteen patients, who postoperatively presented a residual patent distal false lumen, underwent a successful second-stage endovascular stent-graft implantation. Results. One patient died after the surgical stage while there was no death after the endovascular stage with hospital mortality of 4.2%. Follow-up confirmed complete thrombosis of the residual distal false lumen in 95.6% and partial thrombosis in 4.4% of patients with no evidence of endoleaks in the cases that required the endovascular procedure. Overall actuarial survival at 28 months is 92.1% 7.9% with 100% freedom from reoperation. Conclusions. Hybrid treatment of DeBakey type I aortic dissection with aortic arch debranching, using a new multibranched prosthesis (Lupiae Graft; Vascutek Terumo Inc, Scotland, United Kingdom) is confirmed to facilitate the subsequent endovascular completion. Midterm results in terms of survival and distal false lumen thrombosis are satisfactory. Further study of this operation is warranted to confirm the effectiveness and the durability of this approach. (Ann Thorac Surg 2010;90: ) 2010 by The Society of Thoracic Surgeons Accepted for publication July 26, Address correspondence to Dr Marullo, Viale Bracci no. 1, Siena, 53100, Italy; antoninomarullo@hotmail.com. Acute De Bakey type I aortic dissection (AIAD) remains one of the most challenging diseases for cardiothoracic surgeons. Despite technical improvements perioperative mortality rate is still significant [1 3], suggesting in emergency a limited use of ascending aortic or hemiarch replacement in order to allow the primary goal of immediate survival [3, 4]. Moreover, late complications requiring reoperation are reported in almost 40% of patients with late survival at 10 years ranging, between 30% and 60% [5, 6]. Several reports [7 12] have already demonstrated that late complications are related to the fate of residual dissection of the aortic arch or thoracoabdominal aorta, and false lumen patency is actually considered the most significant independent predictor of dissection-related events. Therefore, it is evident that any advancement in surgical strategies for the treatment of AIAD should hence include measures to reduce the likelihood of persistent patency of the distal false lumen and so to eliminate the need for additional operations [4, 6, 8, 13]. Recently, some authors demonstrated that more aggressive surgical strategies with aortic arch replacement, regardless of the location of the entry site or extent of the pathologic process, might improve long-term outcome by decreasing the incidence of residual false lumen patency without increasing morbidity and mortality [13, 14]. Besides, the recent introduction of endovascular stent graft, and the evidence that residual distal false lumen patency has been described in 50% to 70% of patients after ascending aortic replacement and in 15% to 30% of patients after aortic arch replacement [6, 14 17], has stimulated alternative approaches to complex aortic arch pathology and AIAD with the use of surgical techniques that can facilitate subsequent endovascular approach to the descending thoracic aorta [17 24]. The purpose of this study is to describe and to evaluate efficacy and outcome of a hybrid treatment of AIAD using a new multibranched Dacron prosthesis (Lupiae Graft; Vascutek Terumo Inc, Scotland, UK) for a staged endovascular completion. Patients and Methods After approval by Città di Lecce Hospital s Ethical Committee and with the individual informed consent, 24 consecutive patients underwent (between March by The Society of Thoracic Surgeons /$36.00 Published by Elsevier Inc doi: /j.athoracsur

2 1848 MARULLO ET AL Ann Thorac Surg DEBAKEY TYPE I AORTIC DISSECTION 2010;90: Table 1. Clinical Data Mean SD Number % Sex M:F 12:12 50:50 Age (years) Aortic aneurysm Marfan syndrome Symptom status Stable 6 25 Unstable Chest or back pain Severe pain Abrupt onset of pain 6 25 Migrating pain 6 25 TIA Cardiac tamponade Hypotension - shock Any pulse deficit Abdominal pain CHF NIDDM Hypercholesterolemia Hypertension Cr 2.3 mg/dl COPD Atrial Fib./Flutter Moderate AR Severe AR EF EF AR aortic regurgitation (graded as mild, moderate and severe when the Perry index was 0.1 to 0.3, 0.3 to 0.6, and more than 0.6, respectively); atrial fib/flutter atrial fibrillation/flutter; CHF congestive heart failure; COPD chronic obstructive pulmonary disease; Cr creatinine; EF ejection fraction; hypercholesterolemia treated or total cholesterol greater than 200 mg/dl; hypertension treated or blood pressure greater than 140/90 on 1 occasion prior to admission; NIDDM noninsulin-dependent diabetes mellitus; TIA transient ischemic attack. and July 2008) emergency ascending aorta and aortic arch replacement with epiaortic vessels debranching for spontaneously occurring AIAD in the Department of Cardiovascular Surgery at Città di Lecce Hospital, Lecce, Italy. Patients with chronic aortic dissections, iatrogenic aortic dissections, or acute aortic dissections limited to the ascending aorta and the proximal aortic arch were excluded from the study. The patients of the present study were aged 42 to 84 years (mean age years) and 12 (50%) were men. Demographics and clinical data are shown in Table 1. Among known risk factors for adverse outcome, moderate renal dysfunction was present in 4 patients (16%), chronic obstructive pulmonary disease in 10 patients (41%), severe obesity in 3 patients (12%), noninsulin dependent diabetes mellitus in 4 patients (16%), moderate to severe aortic regurgitation in 18 patients (75%), and moderate left ventricular dysfunction in 3 patients (12%). One patient had previous aortic valve replacement and one patient presented an annuloaortic ectasia with a grade 3 aortic regurgitation associated with Marfan syndrome. All patients underwent preoperative computed tomographic (CT) scans to verify the extent of dissection and surgery was performed within 18 hours from the confirmed diagnosis. The primary intimal tear was located by intraoperative transesophageal echocardiography (TEE) and subsequent direct intraoperative observation in the ascending aorta in 4 patients (16%) and in the aortic arch in 14 patients (58%), while the remaining 6 patients (25%) presented a retrograde dissection with the intimal tear in the descending aorta. All patients underwent CT control at hospital discharge to evaluate the descending aorta and short axial images were used to measure the diameter of the false lumen and descending aorta. Operative Technique After induction of general anesthesia with endotracheal intubation as well as bilateral arterial line monitoring, a transesophageal probe was inserted and TEE monitoring was performed throughout the case in all patients for both diagnostic confirmation and therapeutic evaluation. Surgical repair was attempted through a median sternotomy approach with extension of the incision superiorly along the medial border of the left sternocleidomastoid muscle in order to expose epiaortic vessels. The operative data are summarized in Table 2. After full intravenous anticoagulation, either the innominate trunk or the right axillary arteries, exposed through a small infraclavicular incision, were cannulated using an 8-mm interposition Dacron graft. In 2 patients with extensive dissection, involving the innominate artery and right axillary artery, arterial cannulation was performed directly through the left ventricle apex with TEE guidance to assure perfusion of the true lumen [25]. Extracorporeal circulation and systemic cooling were started after cannulation of the right atrium with a standard two-stage cannula, and the heart was vented through the right superior pulmonary vein. The left subclavian artery was then detached off the aortic arch and anastomosed in end-to-end fashion to an 8-mm Dacron graft connected to a separate low-flow (10 ml/kg 1 /min 1 ) perfusion line. The aorta was subsequently cross-clamped and myocardial protection achieved by antegrade or intracoronary infusion of cold Table 2. Operative Data Mean SD Number % Aortic valve and root Replacement Aortic valve repair CPB time (minutes) XC time (minutes) Circulatory arrest time (minutes) Graft size: N N N CBP cardiopulmonary bypass; XC aortic cross-clamp.

3 Ann Thorac Surg MARULLO ET AL 2010;90: DEBAKEY TYPE I AORTIC DISSECTION 1849 Fig. 1. The Lupiae prosthesis (Vascutek Terumo Inc, Scotland, UK). (5 C to 8 C) crystalloid cardioplegia (Custodiol; Koehler Chemie, Alsbach-Haenlein, Germany). The sinuses of Valsalva involved in the dissection were then reinforced with Teflon felt as a neomedia and the aortic root repaired using a sandwich of felt to obliterate the false lumen. In patients with preoperative aortic regurgitation the aortic valve leaflets were resuspended utilizing three 4-0 Ticron (Tyco Healthcare, Norwalk, CT) pledgeted supracommissural sutures and two patients required aortic valve and root replacement. Thereafter the proximal supracoronary aortic anastomosis was performed with 4-0 monofilament sutures using our newly developed Lupiae graft (the roman ancient name of the city of Lecce where this prosthesis and technique were developed) (Vascutek Terumo Inc, Scotland, United Kingdom) constructed with a standard cylindrical Dacron graft with a trifurcated graft of different sizes (10, 10, and 8 mm) and another side branch of 10 mm coming off the main body of the prosthesis (Fig 1). After completion of the proximal anastomosis and achievement of moderate systemic hypothermia (26 C to 28 C), cardiopulmonary bypass was discontinued and selective antegrade cerebral protection begun, with a flow rate of approximately 10 ml/kg 1 / min 1 to maintain the right radial pressure between 40 and 60 mm Hg. Selective antegrade cerebral protection was achieved through the innominate trunk or right axillary artery maintaining left subclavian artery perfusion to assure maximal cerebral and spinal protection. The distal anastomosis of the Lupiae graft (Vascutek Terumo Inc) was then completed with a 4-0 monofilament suture with external and internal Teflon felt stripes. At this point the antegrade systemic perfusion was restarted through the 10-mm side branch of the multibranched prosthesis maintaining the perfusion of the innominate trunk and left subclavian artery. The aortic cross-clamp was released and two branches of the trifurcated graft (coming off very laterally from the main graft toward the superior vena cava) were connected, respectively, to the innominate trunk (10-mm branch) and the left carotid artery (8-mm branch). After rewarming and weaning off extracorporeal circulation, operation was completed by connecting the left subclavian artery either to the 10-mm side branch used previously as arterial inflow, or to the third branch of the trifurcated graft, according to the geometry of the aortic arch vessels (Fig 2). Second Endovascular Stage Fifteen patients (65.2%) underwent a second-stage endovascular descending thoracic aortic repair for residual patency of distal false lumen in the descending aorta with a diameter greater than 22 mm and (or) dilatation of the distal thoracic aorta. Of these, 10 patients (66.7%) presented persistent false lumen with a diameter greater than 22 mm, while a dilatation of the distal thoracic aorta greater than 45 mm was found in 12 patients (80%). Five patients with distal false lumen partial thrombosis presented subclinical abdominal malperfusion signs, probably related to a blind sac effect into the false lumen, while no other major complications were detected during the waiting time between the two procedures. Staged endovascular repair was performed, within 1 and 3 months from surgery, under general anesthesia and TEE control using spinal fluid drainage to minimize the risk of paraplegia. Through a left femoral artery access a selfexpanding stent graft (Valiant; AVE/Medtronic Inc, Santa Rosa, CA) was successfully deployed into the descending thoracic aorta using the Lupiae prosthesis, just distal to the origin of the side branches, as proximal landing zone (Fig 3A 3B). Fig 2. First-stage surgical technique.

4 1850 MARULLO ET AL Ann Thorac Surg DEBAKEY TYPE I AORTIC DISSECTION 2010;90: Fig 3. (A) Second stage endovascular stenting graft repair. (B) Threedimensional computed tomographic scan control after endovascular stenting graft repair. Statistical Analysis Continuous data are expressed as mean standard deviation. Categoric data are expressed as percentages. Survival analyses with the Kaplan-Meier method were used to estimate survival. Statistical analysis was performed with the MedCalc statistical package (MedCalc version ). Results One patient died after surgical stage while there was no death after the endovascular stage with an overall hospital mortality of 4.2%. The single death resulted from multiple organ failure due to infective complication with mediastinitis and septicemia in an 82-year-old patient with preoperative transient cerebral ischemic attack associated with cardiac tamponade and acute renal failure. Cardiopulmonary bypass and aortic cross-clamp time were, respectively, minutes and minutes, while circulatory arrest time was minutes. Postoperative complications were common and are reported in Table 3. One patient (4.2%) underwent reoperation for bleeding. Three patients (12.6%) required prolonged intubation and one underwent tracheostomy. Two patients (8.4%) had postoperative renal dysfunction requiring dialysis, and one (4.2%) required permanent pacemaker implantation. According to the classification of Ergin and colleagues [26], three patients (12.6%) had transient neurologic dysfunction. Predischarge CT scans, performed in all patients who survived first-stage surgical procedure, showed full thrombosis of the false lumen in 7 patients (30.4%), partial thrombosis in 12 patients (52.2 %), and fully patent distal false lumen in 4 patients (17.4 %). The mean diameter of distal false lumen and distal thoracic aorta were, respectively, mm and mm, and two patients had distal thoracic aortic diameter greater than 60 mm. Endovascular procedure was successfully performed in 15 patients with complete thrombosis of the distal false lumen throughout the Table 3. Postoperative Complications Mean SD Number % Inotropes Atrial fibrillation Permanent pacing Bleeding/tamponade Postoperative ventilation: 12 hours hours day 6 25 Chest infection Reintubation 6 25 Tracheostomy Transient stroke Sternotomy req. debrid./res Septicemia due to any cause Cr 2.3 mg/dl Dialysis Peptic ulceration Hospital LOS (days) Cr creatinine; Inotropes any dose of epinephrine or norepinephrine; isoprenaline 0.1 mcg kg -1 min -1 ; dopamine, dobutamine, or enoximone 5 mcg kg -1 min -1 ; LOS length of stay; Sternotomy req. debri./res sternotomy requiring debridement-resinthesis.

5 Ann Thorac Surg MARULLO ET AL 2010;90: DEBAKEY TYPE I AORTIC DISSECTION 1851 Fig 4. Kaplan-Meier overall survival at 36 months. thoracoabdominal aorta and no evidence of endoleaks or major complications. Follow-up was complete in all patients with a mean follow-up time of 13.6 months (range, 5 to 28 months). Data were obtained by outpatient clinic and CT-scan control at intervals of 3, 6, and 12 months after discharge. Complete thrombosis was confirmed in 95.6% of patients with slight or no decrease in aortic diameter, while one patient who did not undergo the endovascular procedure had residual partial patency of the distal false lumen with a diameter of 14 mm and distal thoracic aortic diameter of 38.3 mm. Only one patient died after five months of acute respiratory insufficiency with an overall actuarial survival at 28 months of 92.1% 7.9% and 100% freedom from reoperation (Fig 4). Comment Although the immediate surgical outcome of acute type I aortic dissection has recently improved [1 3], surviving the emergency procedure does not warrant freedom from subsequent aortic events [5, 6]. Several studies have already demonstrated that late complications are related to the fate of residual dissection of the aortic arch or thoracoabdominal aorta, and residual distal false lumen patency related to unresected intimal tear, leakage from the distal anastomosis, or reentry in the distal aorta, is a well-known risk factor for future aortic enlargement [10 12]. The evidence of a high incidence of late complications in the thoracoabdominal aorta has stimulated the use of various techniques and approaches to reduce the incidence of distal false lumen patency. Recent evidence stress the advantages of a more aggressive approach to the aortic arch in AIAD, regardless of the location of the entry site, in terms of decreased incidence of residual distal false lumen patency [13, 14, 27]. Thus, considering that a more radical and extensive approach to the aortic arch does not increase morbidity and mortality compared with surgical strategies limited to the ascending aorta or the hemiarch, extended total arch replacement might be electively indicated in all patients during emergent repair of AIAD; especially in the presence of intimal tear in the aortic arch, retrograde dissections, reentries in the arch or in the proximal descending aorta, Marfan syndrome, arch aneurysm or dilatation, massive arch dissection, and relatively young age [6]. Moreover, recent innovations in endovascular stent grafting of the distal thoracic and thoracoabdominal aorta have generated alternative surgical strategies with the intent to facilitate the endovascular repair. The elephant trunk procedure, first introduced in 1983 by Borst and colleagues, has been used in different studies to reconstruct the aortic arch and provide an optimal Dacron graft landing zone for the endograft. Nevertheless, the need of an elephant trunk longer than 2.5 cm to avoid serious complications, such as coverage of the left subclavian and left carotid arteries, or type I endoleaks, implicates an increased risk of peripheral embolization and (or) paraplegia caused by the flapping action of the elephant trunk and possible clotting around the free floating graft [28, 29]. In the present study all patients with AIAD were approached with aortic arch debranching using a newly developed multibranched Dacron prosthesis for an easier predetermined second-stage endovascular repair. Considering the advantages of an extended repair in terms of residual distal false lumen patency, all patients who survived the surgical stage underwent CT control at hospital discharge to evaluate the distal thoracic and thoracoabdominal aorta. Therefore, hypothesizing that the morphologic status of residual aorta after AIAD extensive repair would mirror a type B dissection, and considering the favorable results of endovascular treatment, we decided to adopt an aggressive approach. Patients who presented either residual false lumen patency with false lumen diameter 22 mm or greater and (or) distal thoracic aorta diameter 45 mm or greater underwent second-staged endovascular completion [10 12]. The use of our new multibranched prosthesis in the surgical stage allowed the reconstruction of the ascending aorta and the aortic arch consenting to obtain an optimal Dacron landing zone of 4 to 6 cm for an easier endovascular stent graft deployment (Figs 1; 2). The presence of a radiopaque marker just distal to the origin of the trifurcated graft assisted the release of the stent graft in the safe area of the Dacron graft, minimizing the risk of type I endoleak that still represents the major adverse complication of the endovascular procedure [30]. Moreover, as previously described [24], the configuration of the Lupiae prosthesis might facilitate a transdiaphragmatic visceral vessels revascularization without crossclamping the diseased abdominal aorta when required. One-stage approach is of course a valid option, but considering the encouraging results in terms of distal false lumen thrombosis after aortic arch replacement and the evidence that an elective staged approach might consent a safer planned strategy, we decided to consider one-stage repair only in patients who presented, acutely, signs and symptoms of mesenteric and end-organ ischemia. In this preliminary experience morbidity and mortality were relatively low and we did not experience adverse complications related to the procedure. This approach allowed to optimize the surgical technique with the reduction of circulatory arrest time and with no need

6 1852 MARULLO ET AL Ann Thorac Surg DEBAKEY TYPE I AORTIC DISSECTION 2010;90: of deep hypothermic circulatory arrest, resulting in a reduction of cardiopulmonary bypass time and complications related to deep hypothermia. The incidence of residual patent false lumen was higher than the one reported by other groups, and interestingly only 17.4% of patients in our series showed fully patent false lumen. Second-staged endovascular completion was performed in 65.2% of patients with complete thrombosis of the distal false lumen without incidence of paralysis and no evidence of progression of the aortic disease or endograft leaks or dislocation. Residual abdominal false lumen patency was observed in only one patient, confirming the effectiveness of this strategy. In this study our experience with Marfan patients is limited to one patient who underwent extensive aortic root and aortic arch replacement shortly followed by staged endovascular repair with thrombosis of the false lumen throughout the thoracoabdominal aorta and no evidence, at twelve months follow-up, of progression of the aortic disease. Therefore, this limited experience does not give clear indication whether a more aggressive management will influence prognosis or offer improved long-term survival in patients with Marfan syndrome. In conclusion, ascending aorta and aortic arch replacement with debranching of epiaortic vessels for spontaneously occurring DeBakey type I aortic dissection, using our new prosthesis, proved to be safe and effective. Second-stage endostent grafting was facilitated, enabling a complete repair in patients with persistent complicated distal false lumen or dilatation of the distal thoracic aorta. These results are encouraging and demonstrate a role for an extensive approach in treatment of AIAD. Further experience and follow-up is required to validate these initial results and to confirm the effectiveness and durability of extensive two-staged repair, and justify an aggressive approach to residual dissected thoracic aorta after extensive AIAD surgical repair. References 1. Westaby S, Saito S, Katsumata T. Acute type A dissection: conservative methods provide consistently low mortality. Ann Thorac Surg 2002;73: Bavaria JE, Brinster DR, Gorman RC, Woo YJ, Gleason T, Pochettino A. Advances in the treatment of acute type A dissection: an integrated approach. Ann Thorac Surg 2002; 74:S Hagan PG, Nienaber CA, Isselbacher EM, et al. The International Registry of Acute Aortic Dissection (IRAD): new insights into an old disease. JAMA 2000;283: Sabik JF, Lytle BW, Blackstone EH, McCarthy PM, Loop FD, Cosgrove DM. Long-term effectiveness of operations for ascending aortic dissections. 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7 Ann Thorac Surg MARULLO ET AL 2010;90: DEBAKEY TYPE I AORTIC DISSECTION Taniguchi K, Toda K, Hata H, et al. Elephant trunk anastomosis proximal to origin of innominate artery in total arch replacement. Ann Thorac Surg 2007;84: Kouchoukos N. Complications and limitations of the elephant trunk procedure. Ann Thorac Surg 2008;85: INVITED COMMENTARY 29. LeMaire SA, Carter SA, Coselli JS. The elephant trunk technique for staged repair of complex aneurysms of the entire thoracic aorta. Ann Thorac Surg 2006;81: Mikhail P, Hes PJ Jr, Klodell CT et al. Closure of type I endoleaks and landing zone preparation of the thoracic aorta. Ann Thorac Surg 2008;85:e9 11. Conventional repair of acute type A aortic dissection is tear oriented. As such, replacement of proximal segments, including the concavity of the aortic arch remains sufficient for the acute situation in the majority of patients. As experience grows, the awareness of late dilatation in primarily untreated segments requiring secondary surgical intervention in downstream segments increases. Consequently, approaches offering one-stop treatment of the entire thoracic aorta are warranted. One of these approaches is promoted by the authors [1]. Their approach facilitates surgery by proximal rerouting of the supra-aortic branches followed by thoracic endovascular aortic repair (TEVAR), thereby realizing entire apposition of the dissecting membrane to the adventitia within the thoracic aorta. It is without doubt that this approach augments the surgical armentarium in treating complex multi-segmental aortic disease in a very elegant manner. Therefore, we encourage the authors to report the longterm results of their technique; as with all other indications for TEVAR, this will extensively justify approaching this disease or put it into question. Before long-term results are available, surgeons should not feel bad when remaining with a tear-oriented approach in treatment of acute type A aortic dissection. Thierry Carrel, MD Martin Czerny, MD Department of Cardiovascular Surgery University Hospital Freiburgstrasse, CH-3010 Berne, Switzerland thierry.carrel@insel.ch Reference 1. Marullo AGM, Bichi S, Pennetta RA, et al. Hybrid aortic arch debranching with staged endovascular completion in De- Bakey type I aortic dissection. Ann Thorac Surg 2010;90: by The Society of Thoracic Surgeons /$36.00 Published by Elsevier Inc doi: /j.athoracsur