- Email: [email protected]
Clinical outcomes of aortic arch hybrid repair in a real-world single-center experience
Clinical outcomes of aortic arch hybrid repair in a real-world single-center experience Tony R. Soares, MD,a,b Ryan Melo, MD,a,b,c Pedro Amorim, MD,a,b,c Augusto Ministro, MD, PhD,a,b,c Gonçalo Sobrinho, MD,a,b,c Luís Silvestre, MD,a,b,c Ruy Fernandes e Fernandes, MD,a,b,c Carlos Martins, MD,a,b José Fernandes e Fernandes, MD, PhD,a,b,c and Luís Mendes Pedro, MD, PhD,a,b,c Lisbon, Portugal
ABSTRACT Objective: Aortic arch aneurysmal disease remains a therapeutic challenge. For patients unsuitable for standard open surgery, hybrid repair with debranching of the supra-aortic arteries followed by thoracic endovascular grafting has been shown to be an effective solution. The aim of this study was to report the clinical outcomes of a single-institution experience using hybrid aortic arch repair. Methods: The cases of all consecutive patients submitted to hybrid aortic arch repair between January 2010 and June 2018 were prospectively collected and retrospectively analyzed. The outcomes of the study were 30-day mortality, perioperative complications, 2-year survival, endoleak, and reintervention rates. Results: A total of 35 patients with a median age of 71 years (interquartile range, 62-77 years) were submitted to hybrid aortic arch repair, with a median follow-up of 26.9 months (interquartile range, 2.4-63.6 months). Ten procedures (28.6%) were performed urgently for contained rupture. The most common etiology was degenerative (n ¼ 14 [40.0%]). The proximal landing zones according to the Ishimaru classification were zone 2 in 20 patients (57.1%), zone 1 in 12 patients (34.3%), and zone 0 in 3 patients (8.6%). Early endoleaks were observed in six patients (17.1%), equally distributed between type I and type II. Late endoleaks were identified in 4 of 24 patients (16.7%; type I, n ¼ 2 [8.3%]; type II, n ¼ 1 [4.2%]; and type III, n ¼ 1 [4.2%]). Thirty-day mortality rate was 14.3% (n ¼ 5) with an early death rate of 8.7% (2/23) in elective cases and 30.0% (3/10) in urgent cases (odds ratio [OR], 4.93; confidence interval [CI], 0.68-35.67; P ¼ .128). Except in one patient, 30-day mortality was associated with landing zone 0 or zone 1 (26.7% vs 5.0%; OR, 6.91; CI, 0.68-69.86; P ¼ .141). Three patients (8.6%) suffered a postoperative stroke, and no episodes of spinal cord ischemia were observed. Two-year survival rate was 67.8% (CI, 49.4%-80.8%). Survival rates were significantly lower with increasing age (hazard ratio [HR], 1.10; CI, 1.03-1.18; P ¼ .004), urgent procedure (HR, 4.80; CI, 1.56-14.80; P ¼ .003), zone 0 or zone 1 (HR, 6.34; CI, 1.73-23.18; P ¼ .001), presence of arrhythmia (HR, 3.76; CI, 1.22-11.62; P ¼ .013), and cerebrovascular disease (HR, 4.12; CI, 1.38-12.35; P ¼ .006). A multivariate analysis identified age (HR, 1.11; P ¼ .047) and zone 0 or zone 1 (HR, 4.93; P ¼ .033) as the only predictors for overall mortality. Conclusions: Hybrid aortic arch repair seems to be an alternative for higher risk patients not suitable for open repair, but selection of patients is crucial and may benefit from further refinement. In this study, worse outcomes were seen in older patients and those who required more proximal landing zones. (J Vasc Surg 2020;-:1-9.) Keywords: Aortic arch; Endovascular procedures; Multimorbidity; Stroke; Spinal cord ischemia
Aortic arch aneurysmal disease remains a challenge for the contemporary surgeon.1 Open repair is the “gold standard” approach for the management of aortic arch aneurysms. However, it may require hypothermic circulatory arrest and cardiopulmonary bypass,2-4 and many patients
From the Vascular Surgery Service, Heart and Vessels Department, Hospital Santa Maria (CHULN)a; the Lisbon Academic Medical Centreb; and the Faculty of Medicine, University of Lisbon.c Author conflict of interest: none. Correspondence: Tony R. Soares, MD, Hospital de Santa Maria, Centro Hospitalar Universitário Lisboa Norte, EPE, Serviço de Angiologia e Cirurgia Vascular, Avenida Professor Egas Moniz, 1649-035 Lisboa, Portugal (e-mail: [email protected]). The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. 0741-5214 Copyright Ó 2019 by the Society for Vascular Surgery. Published by Elsevier Inc. https://doi.org/10.1016/j.jvs.2019.11.033
will not benefit from the open surgical treatment because of their frail condition and associated comorbidities.2-4 Endovascular technology has prompted new solutions to the approach to the aortic arch, expanding the treatment to higher risk patients considered otherwise poor candidates for open repair. In 2001, Ishimaru proposed an anatomic landing zone classification to indicate the proximal deployment site of the endograft, making it possible to standardize the types of debranching and to evaluate the indications for treatment as well as to compare results.5 The use of endografts in the aortic arch implies rerouting of the supra-aortic trunks, and the combination of these two concepts is known as hybrid surgery. These hybrid procedures take advantage of the best of both worlds, using open and endovascular techniques to overcome each one’s major limitations, and hybrid surgery has been shown to provide a successful treatment alternative for otherwise untreatable patients. 1
2
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The aim of this study was to report the early and midterm clinical outcomes of hybrid aortic arch repairs performed in a single institution for high-risk patients deemed unfit for open surgery, thus providing information from real-world experience with this approach.
ARTICLE HIGHLIGHTS d
d
METHODS Study design and patient population. Within the framework of the Heart and Vessels Department, a patient-tailored approach for the management of aortic arch aneurysms according to their clinical status was provided, and each patient was assessed in a multidisciplinary meeting involving vascular surgery, cardiothoracic surgery, cardiology, and anesthesiology teams. A preliminary evaluation, with full history and physical examination, blood analysis, 12-lead electrocardiography, radiography, and echocardiography, was performed for all patients. After this assessment, patients considered for open surgery were individually evaluated with coronary angiography, exercise stress testing for myocardial ischemia, and pulmonary function tests according to the multidisciplinary team. All criteria used for the surgical planning process were relative factors and did not serve as absolute indications for or contraindications to open surgery or hybrid aortic arch repair. Advanced age, frailty, significant comorbidities such as cardiac disease (eg, nonrevascularized coronary disease, heart failure), severe pulmonary function failure, history of stroke, chronic kidney disease, and history of sternotomy or patients who refused open surgery were relevant factors favoring hybrid aortic arch repair. However, the multidisciplinary team made the final decision after all these factors were considered. Patients considered fit for open surgery were referred to the Cardiothoracic Surgery servicedabout 10 to 15 patients a year. All the patients accepted for hybrid aortic arch repair were treated by the Vascular Surgery service. This study was conducted as a retrospective, noncomparative, single-center analysis of prospectively collected data of hybrid arch procedures performed in a tertiary academic hospital. The cases of all consecutive patients submitted to hybrid aortic arch repair between January 2010 and June 2018 were prospectively collected until December 2018. Patients submitted to full open surgery or pure endovascular procedures (ie, total endovascular arch repair with chimney techniques or branched arch endografts) were excluded, as were patients treated with frozen elephant trunk techniques. Demographic and study data were obtained from hospital medical records. All patients provided informed consent before treatment, and Institutional Review Board approval was waived for this study. Procedures. All patients were preoperatively evaluated by computed tomography angiography for endograft planning. Landing zones of at least 20 mm in length,
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Type of Research: Retrospective review of prospectively collected single-center data. Key Findings: Thirty-five patients with aortic arch aneurysms unsuitable for open surgery were submitted to hybrid aortic arch repair. The 30-day mortality and stroke rates were 14.3% and 8.6%, respectively, without spinal cord ischemia, and 2-year survival was 67.8%. Increased age and proximal landing zones were independent predictors of overall mortality. Take Home Message: Hybrid aortic arch repair is a valid option for higher risk patients; advanced age and need of more proximal landing zones are associated with worse outcomes.
with a proximal oversizing of 10% to 15% in dissections and 15% to 20% in degenerative aneurysms, were selected. The endograft choice was based on aortic arch morphologic and pathologic features as well as the surgeon’s preference. All procedures were performed in the operating room using the portable BV 300 C-arm (Philips Medical Systems, Eindhoven, The Netherlands) before 2016 and the Veradius Unity mobile C-arm system (Philips Medical Systems) after 2016. The facility lacks a hybrid operating room with a fixed imaging system. The patients were operated on under general anesthesia with intraoperative anticoagulation with unfractionated heparin (in general, 2500 units before clamping for debranching procedures; further doses of heparin were administered as needed to achieve an activated clotting time of 250 seconds or longer during deployment of the endovascular graft). Preoperative cerebrospinal fluid (CSF) drainage was selectively used in patients with higher risk for spinal cord ischemia (SCI; >200 mm of expected covered length of the aorta, endograft covering of the thoracoabdominal transition, previous abdominal aortic surgery, or hypogastric artery disease). The first patients were monitored by transcranial Doppler during the procedures. However, because it was difficult to differentiate air embolization from solid embolic material, we decided not to use it routinely, considering that no relevant information was provided by the technique. Total supra-aortic vessel debranching was performed with bypass grafting from the ascending aorta through a ministernotomy. For zone 1, patients were submitted to extra-anatomic right common carotid artery (RCCA)left common carotid artery (LCCA)-left subclavian artery (LSA) bypass or RCCA-LSA graft with reimplantation of the LCCA with subsequent ligation or embolization of the proximal LSA. LSA revascularization for Ishimaru zone 2 was performed with LCCA-LSA bypass or LSA to LCCA transposition. The vascular access was obtained
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by femoral cutdown. In selected cases, precise endograft positioning was obtained with rapid pacing or partial right atrial inflow occlusion using a compliant occlusion balloon in the inferior vena cava. Open and endovascular procedures were performed either synchronously or staged. A single-stage procedure was generally the preferred approach; however, it requires longer operative times and increased blood loss, which is more stressful for the patient and the surgical team. Therefore, the choice between staged and simultaneous procedures was at the discretion of the surgeon. All emergent patients underwent a single-stage procedure. Follow-up. Postoperative computed tomography angiography was routinely performed before discharge, at 6 and 12 months postoperatively, and afterward on a yearly basis. In addition, all patients underwent clinical examination and regular duplex ultrasound evaluation of the supra-aortic reconstruction. Study end points. The end points for the study were 30-day mortality, 2-year survival rates, postoperative complications, and endoleak and reintervention rates. Perioperative or early events were defined as occurring within the first 30 postoperative days; late events occurred after 30 days. Statistical analysis. A retrospective analysis of prospectively collected data was performed. Continuous variables were presented as median with interquartile range (IQR) from 25th to 75th percentile and compared between groups using the Mann-Whitney U test. Categorical variables were presented by absolute numbers with percentage values and compared between groups using the Fisher exact test. Time-to-event end points were described using Kaplan-Meier estimates. Survival curves were compared using log-rank tests for categorical predictors. Odds ratio (OR) and hazard ratio (HR) with 95% confidence intervals (CIs) were estimated with logistic regression and univariate Cox analysis, respectively. The Cox proportional hazards model was used to determine independent predictors of death. The proportional hazard assumption was assessed with Schoenfeld residuals. All analyses were considered statistically significant if a two-tailed P value < .05 was observed. Statistical analysis was carried out using Stata 12.1 (StataCorp LP, College Station, Tex).
RESULTS Patient and procedural characteristics. A total of 35 patients were submitted to hybrid aortic arch repair with debranching of the supra-aortic arteries followed by thoracic endovascular aortic repair (TEVAR). The majority of the patients were male (85.7%; 30 male, 5 female), with a median age of 71 years (IQR, 62-77 years), and 40% of the population were older than 75 years. Six patients (17.1%) had a history of sternotomy, having been
Table I. Demographic characteristics and comorbidities Demographics Patients
Total (N ¼ 35) 35
Age, years
71 (62-77)
Male
30 (85.7)
Risk factors Smoking history
20 (57.1)
Active smoker
10 (28.6)
Former smoker
10 (28.6)
Diabetes mellitus
13 (37.1)
Hypertension
29 (82.9)
Coronary artery disease
13 (37.1)
Dyslipidemia
20 (57.1)
Chronic kidney disease
8 (22.9)
Cerebrovascular disease
8 (22.9)
Arrhythmia
7 (20.0)
Thoracosternotomy
6 (17.1)
Categorical variables are presented as number (%). Continuous variables are presented as median (interquartile range).
submitted primarily to procedures such as Mustard surgery, Bentall procedure, repair of coarctation of the aorta, coronary artery bypass grafting, and aortic valve replacement. Demographic characteristics with comorbidities are presented in Table I. Ten procedures (28.6%) were performed urgently for contained rupture. Indications for treatment and other intraoperative characteristics are reported in Table II. The most common cause was degenerative aneurysm (n ¼ 14 [40.0%]), followed by chronic dissection with aneurysmal degeneration (n ¼ 7 [21.2%]), chronic post-traumatic aneurysm (n ¼ 7 [20.0%]), pseudoaneurysm (n ¼ 3 [8.6%]), type I endoleak (n ¼ 2 [5.7%]), acute dissection with malperfusion syndrome (n ¼ 2 [5.7%]), and chronic dissection with symptomatic extreme collapse of the true lumen (n ¼ 1 [2.9%]). The proximal landing zones according to the Ishimaru classification were zone 2 in 20 patients (57.1%), zone 1 in 12 patients (34.3%), and zone 0 in 3 patients (8.6%). The detailed debranching procedures are described in Table III. The pretracheal route was used for RCCALCCA bypass in all but one case, in which a retroesophageal position was chosen. Eighteen (51.4%) hybrid procedures were staged, all in the emergent patients submitted to a single-stage intervention. Endografts were predominantly Zenith Alpha or TX2 (n ¼ 29 [82.9%]; Cook Medical, Bloomington, Ind), followed by Gore TAG Conformable Thoracic Stent Graft (n ¼ 3 [8.6%]; W. L. Gore & Associates, Flagstaff, Ariz), Valiant (n ¼ 2 [5.7%]; Medtronic, Santa Rosa, Calif), and JOTEC (n ¼ 1 [2.9%]; JOTEC GmbH, Hechingen, Germany). Deliberate hypotension for precise endograft deployment was used in 17.1% (n ¼ 6) of cases (rapid
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Table II. Intraoperative characteristics Variables
Total (N ¼ 35)
Table III. Surgical procedures according to Ishimaru zones Debranching intervention
Procedure status Urgent Elective
10 (28.6)
Zone 0
Ascending aortic debranching
25 (71.4)
Zone 1
RCCA-LCCA-LSA
Diagnosis Degenerative aneurysm
14 (40.0)
Chronic dissection with aneurysmal degeneration
7 (20.0)
Chronic post-traumatic aneurysm
6 (17.1)
Pseudoaneurysm
3 (8.6)
Acute dissection
2 (5.7)
Type I endoleak Chronic dissection Intraoperative lumbar spinal fluid drainage Aortic coverage, mm Staged procedures
2020
Zone 2
No. (%) 3 (9.1) 10 (30.3)
RCCA-LSA þ LCCA reimplantation
1 (3.0)
LCCA-LSA þ left VA reimplantation (bovine aortic arch)
1 (3.0)
LCCA-LSA
16 (45.7)
LSA to LCCA transposition
2 (6.1)
LCCA-LSA þ left VA reimplantation
2 (6.1)
2 (5.7) 1 (2.9)
Total
21 (61.8)
35 (100)
LCCA, Left common carotid artery; LSA, left subclavian artery; RCCA, right common carotid artery; VA, vertebral artery.
201 (156-300) 18 (51.4)
Categorical variables are presented as number (%). Continuous variables are presented as median (interquartile range).
pacing in five patients and partial venous inflow occlusion of the inferior vena cava in one patient). Preventive CSF drainage was performed the day before surgery in 61.8% (n ¼ 21) of the patients. Perioperative outcomes. Perioperative complications are presented in Table IV. Three patients (8.6%) suffered a postoperative stroke, one in the posterior territory without sequelae. In two patients, stroke was associated with in-hospital death (one case involving the anterior circulation and another involving both territories). All stroke patients were previously submitted to LSA revascularization. No episodes of SCI were observed. The overall 30-day mortality was 14.3% (n ¼ 5), which led to a 30-day mortality of 8.7% (2/23) for elective cases and 30.0% (3/10) for urgent cases. Of these five deaths, four occurred in patients with landing zone 0 or zone 1. Deaths were due to ischemic stroke (n ¼ 2), sepsis after esophageal fistula and infection of the retroesophageal graft (n ¼ 1), multiorgan failure (n ¼ 1), and hemorrhagic shock in a patient submitted to total supra-aortic debranching with perianastomotic bleeding in the ascending aorta (n ¼ 1). In addition, five deaths were observed within 6 months of surgery; two of them were in-hospital death with multiorgan failure as the cause (Table V). There was no significant difference in the outcomes between simultaneous repair and staged repair. The 30-day mortality rate was 11.8% (2/15) for simultaneous repair and 16.7% (3/15) for staged repair (OR, 0.67; CI, 0.10-4.58; P ¼ .528). The rate of early stroke was 5.9% (1/17) for simultaneous repair and 11.1% (2/18) for staged repair (OR, 0.50; CI, 0.04-6.08; P ¼ .522).
Stroke was not related to age (OR, 1.07 per year; CI, 0.95-1.21; P ¼ .254), proximal landing zone (OR, 1.38; CI, 0.17-11.15; P ¼ 1.000), urgent procedure (OR, 0.81; CI, 0.07-8.91; P ¼ 1.000), or previous cerebrovascular disease (OR, 1.14; CI, 0.10-12.78; P ¼ 1.000). Endoleaks, reinterventions, and late follow-up outcomes. The median follow-up was 26.9 (IQR, 2.4-63.6) months, with a 2-year survival rate of 67.8% (CI, 49.4%80.8%). Causes of death are presented in Table V. Two deaths were related to rupture of aortic aneurysm. One patient with a concomitant type IV thoracoabdominal aneurysm was intended to be treated soon after complete recovery from the aortic arch repair. However, the thoracoabdominal aneurysm ruptured 2.4 months after aortic arch hybrid repair. The other patient was in a close follow-up program because of an abdominal aortic aneurysm with 5-cm diameter and was admitted with a rupture 4 years later. Seven patients (20.0%) underwent aorta-related reinterventions, and three of them were submitted to open surgery (Table VI). Early endoleaks were observed in six patients (17.1%), equally distributed between type I (n ¼ 3 [8.6%]) and type II (n ¼ 3 [8.6%]). Late endoleaks were identified in 4 of 24 patients (16.7%; type I, n ¼ 2 [8.3%]; type II, n ¼ 1 [4.2%]; and type III, n ¼ 1 [4.2%]), but 11 patients were excluded (10 deaths occurred before the 6-month computed tomography scan, and one patient was recently treated <6 months). All type I endoleaks, early and late, were successfully treated, except in one patient waiting for a suitable custom-made endograft. The only type III endoleak was successfully treated with an additional TEVAR. Additional details are shown in Fig 1. Endoleak rates, early and late, were not related to proximal landing zone (OR, 2.83; CI, 0.55-14.47; P ¼ .192), urgent procedure (OR, 1.71; CI, 0.32-9.11; P ¼ .411), or age (OR, 1.02; CI, 0.95-1.10; P ¼ .409).
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Table IV. Complications
Table V. Causes of death
Complications
No. (%)
Cause of death
Time
No. (%)
Stroke
3 (8.6)
Pneumonia
2.4 months
1 (2.9)
a
Transient renal dysfunction
3 (8.6)
Hemothorax
10 days
1 (2.9)
Cervical hematomaa,b
2 (5.7)
2.4 months
1 (2.9)
Pneumonia
1 (2.9)
Type IV thoracoabdominal aneurysm rupture
Venous thromboembolismb
1 (2.9)
58.1 months
1 (2.9)
Left CCA stenosis (endograft maldeployment)
1 (2.9)
Abdominal aortic aneurysm rupture Septic shock (esophageal fistula with graft infection)
27 days
1 (2.9)
Cardiogenic shock
1.2 months
1 (2.9)
Stroke
2 days
2 (5.7)
Tracheostomy
c
SCI
1 (2.9) 0 (0.0)
CCA, Common carotid artery; SCI, spinal cord ischemia. a Complications of transient renal dysfunction and cervical hematoma occurred in the same patient. b Complications of cervical hematoma and venous thromboembolism occurred in the same patient. c Complication of tracheostomy and pneumonia occurred in the same patient.
16 days Multiorgan failure
DISCUSSION Aortic arch repair is associated with a substantial perioperative risk regardless of the type of procedure chosen. Outcomes of open surgery have been improving with the introduction of new techniques and surgical refinements in circulatory management and cerebral protection.6,7
3 (8.6)
3.2 months 2.3 months Unknown cause
Determinants of mortality. Patients who died in the perioperative period had a median age of 76 years (IQR, 73-77 years) as opposed to 69 years (IQR, 61-77 years) for the surviving patients (OR, 1.06; CI, 0.95-1.18; P ¼ .346). Of the five perioperative deaths, four occurred in patients with landing zone 0 or zone 1 (4/15 [26.7%]) vs zone 2 (1/20 [5.0%]; OR, 6.91; CI, 0.68-69.86; P ¼ .141). Perioperative mortality rate was 8.7% (2/23) in elective cases and 30% (3/10) in urgent cases (OR, 4.93; CI, 0.68-35.67; P ¼ .128). Survival rates were significantly lower in urgent procedures (HR, 4.80; CI, 1.56-14.80; P ¼ .003), with a 2-year survival rate of 84.0% (CI, 63.8-93.7) in elective cases and 23.3% (CI, 3.6-52.9) in urgent ones. Those patients in whom landing zone 0 or zone 1 was used had a higher mortality (HR, 6.34; CI, 1.73-23.18; P ¼ .001), with 2-year survival rates of 40.0% (CI, 16.5-62.8) when proximal deployment was in zone 0 or zone 1 vs 89.4% (CI, 63.8-97.3) when zone 2 was feasible (Fig 2). Reduced survival rate was significantly associated with age (HR, 1.10; CI, 1.03-1.18; P ¼ .004), presence of arrythmia (28.6% [CI, 4.161.2] vs 78.1% [CI, 57.26-89.5]; HR, 3.76; CI, 1.22-11.62; P ¼ .013), and cerebrovascular disease (37.5% [CI, 8.767.4] vs 77.0% [CI, 55.7-89.0]; HR, 4.12; CI, 1.38-12.35; P ¼ .006). The remaining risk factors and patient characteristics were not statistically significant. In a multivariate analysis, age (HR, 1.11; CI, 1.00-1.23; P ¼ .047) and proximal landing in zone 0 or zone 1 (HR, 4.93; CI, 1.14-21.32; P ¼ .033) were the only predictors for overall mortality. Urgent treatment, sex, and presence of arrhythmia or cerebrovascular disease were not significantly associated with overall mortality.
25 days
43.2 months
2 (5.7)
7.0 months Total
e
13 (37.1)
However, for higher risk patients unsuitable for open surgery, less invasive procedures such as hybrid repair might be the only viable option. This study evaluated a real-world single-center series with an overall 30-day mortality rate of 14.7%, a stroke rate of 8.6%, and no SCI. Previously published studies showed perioperative mortality rates ranging from 3.7% to 20%,1,8-14 apparently higher in those series with more urgent cases (19.6%-27.3%), in which reported perioperative mortality ranged between 9.8% and 20.4%, as listed in Table VII, which is in agreement with our findings. This study reported 28.6% of patients treated urgently with a perioperative mortality rate of 30.0% vs 8.7% for elective cases. Previous literature had already pointed out how urgent cases resulted in worse outcomes.9,14 We did not obtain a statistically significant difference for perioperative mortality rates between urgent and elective patients, probably related to the limited sample size. However, we did observe a significant decrease in the overall survival rate of patients treated urgently. Several trials comparing hybrid aortic arch repair with open surgery outcomes reported inconclusive results, mostly because of selection bias related to patients’ risk profiles.2,9,15,16 However, there is some evidence of comparable outcomes between the two approaches when a risk stratification was performed. In a propensity score-matched analysis, 337 patients submitted to open surgery were compared with 58 patients treated by a hybrid approach, obtaining 43 matched pairs.3 Compared with open surgery, hybrid aortic arch repair was associated with similar perioperative mortality rates and midterm outcomes but with higher incidence of stroke.3
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Table VI. Endoleaks and other complications with subsequent reinterventions No.
Ishimaru zone
4
Zone 0
Early endoleak
Late endoleak
e
e
Postoperative complication Hemothorax related to bleeding from ascending aorta proximal to debranching (hemorrhagic shock)
Reintervention Emergent exploratory sternotomy and hemostatic sutures at 10 days
8
Zone 2
e
Type III
13
Zone 1
Type II
e
TEVAR at 17.8 months
14
Zone 1
e
Type I
Chimney TEVAR; chimney for BCT at 20 months
21
Zone 1
Type I
e
Chimney TEVAR; chimney for BCT at 7 days
24
Zone 2
e
e
LCCA stenosis (endograft maldeployment)
Right subclavian-LCCA bypass at 1.6 months
31
Zone 1
Type I (1)
e
Wound infection (2)
Wrapping of the ascending aorta at 5 days Substitution of Dacron debranching by venous grafts at 20 days
LSA embolization at 1.0 month
BCT, Brachiocephalic trunk; LCCA, left common carotid artery; LSA, left subclavian artery; TEVAR, thoracic endovascular aortic repair.
Fig 1. Diagram of endoleaks and subsequent reinterventions. BCT, Brachiocephalic trunk; CT, computed tomography; SCA, subclavian artery; TEVAR, thoracic endovascular aortic repair.
Cerebrovascular events are one of the major drawbacks of endovascular techniques approaching the aortic arch.17 Series similar to this study reported rates of stroke ranging from 3% to 29%1,3,9-14 (Table VII). A systematic review and meta-analysis suggested that the stroke incidence is higher if the LSA is covered without revascularization during TEVAR (pooled stroke incidence of 8.0% if the LSA is covered without revascularization vs 5.3% if the LSA is covered but revascularized vs 3.2% when the LSA is uncovered),18 thus supporting a policy for subclavian revascularization as adopted in our practice. In addition, some centers are exploring other methods to prevent these complications, such as the use of carbon dioxide to flush aortic stent grafts.17
Paraplegia, another devastating neurologic complication of thoracic and thoracoabdominal aortic repair, has dramatic repercussions on the patient’s quality of life and is an important factor in reduced long-term survival.19-21 Previous series of hybrid aortic arch repair reported rates of SCI up to 7.4%, with an average covered aortic length between 136 and 230 mm.1,8,10-12,14 The role of CSF drainage is unclear. Canaud et al14 did not use it prophylactically and had a rate of paraplegia of 4.5% with a mean length of covered aorta of 180 mm. Melissano et al12 performed CSF drainage in all cases with a planned coverage of the descending thoracic aorta >200 mm, previous abdominal aortic repair, or covering of critical intercostal arteries, reporting 2.1% SCI in a
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Fig 2. Kaplan-Meier analysis of (A) overall survival and according to (B) urgent procedures and (C) proximal landing zones
population of 143 patients. However, the aortic coverage length was not reported. Despite a median covered aortic length of 201 mm, we observed a remarkable outcome with no cases of paraparesis or paraplegia. This result could be related to the adopted program for SCI prevention with high rates of preoperative CSF drainage, permissive hypertension (median arterial pressure $80 mm Hg), hemoglobin level $10 g/dL, and preservation of the LSA and the hypogastric arteries. However, some authors did not perform preventive CSF drainage, reserving it for SCI occurrence, which may explain their increased rates of SCI.4,14 This passive approach could have some advantages, such as decreasing the risk of severe complications like epidural hematoma and meningitis with pooled rate estimates of 1.7% and 0.1%, respectively.21 However, CSF drainage is
the only preventive measure supported by a randomized trial22 and by U.S. guidelines (class IB) and European guidelines (class IIB).23,24 We do recommend an aggressive protocol to prevent SCI. Our midterm survival rated67.8% for 2 yearsdis comparable to that of other series with similar high rates of urgent cases in their population (ie, w30%): Hiraoka et al9 with a 3-year survival rate of 63.9%, Lotfi et al11 with a 2-year survival rate of 73%, and Canaud et al14 with an overall survival rate of 70%. Whereas our results were comparable to those in the literature, we recognize that 28.6% of our population have died in the first 6 months; therefore, selection of patients may benefit from further refinement. However, we are dealing with a highrisk subgroup difficult to stratify because of the absence of the appropriate tools to assess perioperative risk. The
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Table VII. Outcomes of hybrid aortic arch repair in other series: Literature review Stroke, %
CSF drainage, %
SCI, %
Survival, %
7.4
e
7.4 (permanent)
85.9 (2 years)
28.6
e
2.9
63.9 (3 years)
No.
Murashita et al8 (2012)
27
0
Hiraoka et al9 (2015)
35
25.7
De Rango et al1 (2014)
104
6.7
29.2 (mean)
5.8 (total)
3.8
2.9
4.8 (total) 2.9 (permanent)
89.0 (1 year) 82.8 (3 years)
Chiesa et al10 (2014)
179
e
27.3 (mean)
4.5 (total)
3.4
e
1.1 (permanent)
e
51
19.6
15 (mean)
9.8 (total) 4.9 (elective) 30.0 (urgent)
11.8
e
5.9 (total) 3.9 (permanent)
Melissano et al12 (2012)
143
e
4.2 (total)
2.8
21.7
2.1
e
Schumacher et al13 (2006)
25
32
21 (mean)
20.0 (total)
4.0
0
e
Canaud et al14 (2010)
44
27.3
29.9 (mean)
20.4 (total) 15.6 (elective) 33.3 (urgent)
6.8
0
4.5 (total) 2.3 (permanent)
Current study
35
28.6
26.9 (median)
14.3 (total) 8.7 (elective) 30.0 (urgent)
8.6
61.8
0
Author (year)
Lotfi et al11 (2013)
Follow-up, months
30-day mortality, %
Urgent, %
7 (median) e
e
0 14.3 (total) 7.7 (elective) 33.3 (urgent)
78 (1 year) 73 (2 years)
70 (overall)
67.8 (2 years)
CSF, Cerebrospinal fluid drainage; SCI, spinal cord ischemia.
well-known European System for Cardiac Operative Risk Evaluation (EuroSCORE I and II) and the Society of Thoracic Surgeons Predicted Risk of Mortality were validated for cardiac surgery but not for aortic diseases. A recent expert consensus recognized that these scores and other severity scores are inappropriate risk prediction tools for this population in particular.25 To surpass this situation, the Society of Thoracic Surgeons Task Force on Aortic Surgery rewrote the sections concerning the aortic arch and thoracic aortic surgery to reflect new surgical techniques.25,26 It is clear that proximal aortic arch repair is associated with worse outcomes,1,2,9,12,27 and our results were in agreement, confirming a 2-year-survival rate of 89.4% in zone 2 compared with 40.0% in zone 0 and zone 1. In fact, a multivariate analysis identified proximal landing zone and age as the only predictors for overall mortality in our study. Benrashid et al2 reported an institutional shift away from zone 0 hybrid aortic arch repair after their previous results with high mortality rates in proximal landing zones. However, in this study, some patients requiring the use of zone 0 and zone 1 also had a prohibitive risk for open surgery, which led us to seek other viable options.
The study of Benrashid et al2 is also relevant because the authors followed a patient selection policy similar to our institution’s, achieving lower long-term survival outcomes in the hybrid higher risk group compared with the lower risk patients treated by open surgery. However, the aorta-related survival was similar in both groups, which favors the careful selection policy between open and hybrid interventions that we also follow in our center. We acknowledge some limitations in the study. This is a single-center retrospective analysis, without a comparative group, and with some heterogeneity of patients regarding disease of the aorta.
CONCLUSIONS The aortic arch is one of the most challenging territories for endovascular techniques, and fit patients are still selected for open surgery. Hybrid aortic arch repair seems to be a valid alternative to open surgery and allows the treatment of higher risk patients, but selection of patients is crucial and may benefit from further refinement. In our “real-world” study, survival was independently reduced by age and patients requiring more proximal landing zones.
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AUTHOR CONTRIBUTIONS Conception and design: TS, LP Analysis and interpretation: TS, RM, PA, AM, GS, LS, RFeF, CM, JFeF, LP Data collection: TS, LP Writing the article: TS, LP Critical revision of the article: TS, RM, PA, AM, GS, LS, RFeF, CM, JFeF, LP Final approval of the article: TS, RM, PA, AM, GS, LS, RFeF, CM, JFeF, LP Statistical analysis: TS Obtained funding: Not applicable Overall responsibility: LP
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15.
16.
17.
REFERENCES 1. De Rango P, Cao P, Ferrer C, Simonte G, Coscarella C, Cieri E, et al. Aortic arch debranching and thoracic endovascular repair. J Vasc Surg 2014;59:107-14. 2. Benrashid E, Wang H, Keenan JE, Andersen ND, Meza JM, McCann RL, et al. Evolving practice pattern changes and outcomes in the era of hybrid aortic arch repair. J Vasc Surg 2016;63:323-31. 3. Hiraoka A, Chikazawa G, Totsugawa T, Tamura K, Ishida A, Sakaguchi T, et al. Objective analysis of midterm outcomes of conventional and hybrid aortic arch repair by propensityscore matching. J Thorac Cardiovasc Surg 2017;154:100-6.e1. 4. Vallejo N, Rodriguez-Lopez JA, Heidari P, Wheatley G, Caparrelli D, Ramaiah V, et al. Hybrid repair of thoracic aortic lesions for zone 0 and 1 in high-risk patients. J Vasc Surg 2012;55:318-25. 5. Mitchell RS, Ishimaru S, Ehrlich MP, Iwase T, Lauterjung L, Shimono T, et al. First International Summit on Thoracic Aortic Endografting: roundtable on thoracic aortic dissection as an indication for endografting. J Endovasc Ther 2002;9(Suppl):II98-105. 6. Sundt TM, Orszulak TA, Cook DJ, Schaff HV. Improving results of open arch replacement. Ann Thorac Surg 2008;86: 787-96. 7. Ouzounian M, LeMaire SA, Coselli JS. Open aortic arch repair: state-of-the-art and future perspectives. Semin Thorac Cardiovasc Surg 2013;25:107-15. 8. Murashita T, Matsuda H, Domae K, Iba Y, Tanaka H, Sasaki H, et al. Less invasive surgical treatment for aortic arch aneurysms in high-risk patients: a comparative study of hybrid thoracic endovascular aortic repair and conventional total arch replacement. J Thorac Cardiovasc Surg 2012;143:1007-13. 9. Hiraoka A, Chikazawa G, Tamura K, Totsugawa T, Sakaguchi T, Yoshitaka H. Clinical outcomes of different approaches to aortic arch disease. J Vasc Surg 2015;61:88-95. 10. Chiesa R, Bertoglio L, Rinaldi E, Tshomba Y. Hybrid repair of aortic arch pathology. Multimed Man Cardio-Thoracic Surg 2014;2014:mmu003. 11. Lotfi S, Clough RE, Ali T, Salter R, Young CP, Bell R, et al. Hybrid repair of complex thoracic aortic arch pathology: long-term outcomes of extra-anatomic bypass grafting of the supra-aortic trunk. Cardiovasc Intervent Radiol 2013;36: 46-55. 12. Melissano G, Tshomba Y, Bertoglio L, Rinaldi E, Chiesa R. Analysis of stroke after TEVAR involving the aortic arch. Eur J Vasc Endovasc Surg 2012;43:269-75. 13. Schumacher H, Von Tengg-Kobligk H, Ostovic M, Henninger V, Ockert S, Böckler D, et al. Hybrid aortic procedures for endoluminal arch replacement in thoracic
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aneurysms and type B dissections. J Cardiovasc Surg (Torino) 2006;47:509-17. Canaud L, Hireche K, Berthet JP, Branchereau P, MartyAné C, Alric P. Endovascular repair of aortic arch lesions in high-risk patients or after previous aortic surgery: midterm results. J Thorac Cardiovasc Surg 2010;140:52-8. Sood V, Patel HJ, Williams DM, Dasika NL, Yang B, Deeb GM. Open and endovascular repair of the nontraumatic isolated aortic arch aneurysm. J Vasc Surg 2014;60:57-63. De Rango P, Ferrer C, Coscarella C, Musumeci F, Verzini F, Pogany G, et al. Contemporary comparison of aortic arch repair by endovascular and open surgical reconstructions. J Vasc Surg 2015;61:339-46. Rohlffs F, Tsilimparis N, Saleptsis V, Diener H, Debus ES, Kölbel T. Air embolism during TEVAR: carbon dioxide flushing decreases the amount of gas released from thoracic stent-grafts during deployment. J Endovasc Ther 2017;24:84-8. von Allmen RS, Gahl B, Powell JT. Editor’s choicedincidence of stroke following thoracic endovascular aortic repair for descending aortic aneurysm: a systematic review of the literature with meta-analysis. Eur J Vasc Endovasc Surg 2017;53:176-84. Tenorio ER, Eagleton MJ, Kärkkäinen JM, Oderich GS. Prevention of spinal cord injury during endovascular thoracoabdominal repair. J Cardiovasc Surg (Torino) 2019;60: 54-65. Svensson LG, Crawford ES, Hess KR, Coselli JS, Safi HJ. Experience with 1509 patients undergoing thoracoabdominal aortic operations. J Vasc Surg 1993;17:357-70. Rong LQ, Kamel MK, Rahouma M, White RS, Lichtman AD, Pryor KO, et al. Cerebrospinal-fluid drain-related complications in patients undergoing open and endovascular repairs of thoracic and thoraco-abdominal aortic pathologies: a systematic review and meta-analysis. Br J Anaesth 2018;120: 904-13. Coselli JS, LeMaire SA, Köksoy C, Schmittling ZC, Curling PE. Cerebrospinal fluid drainage reduces paraplegia after thoracoabdominal aortic aneurysm repair: results of a randomized clinical trial. J Vasc Surg 2002;35:631-9. Hiratzka LF, Bakris GL, Beckman JA, Bersin RM, Carr VF, Casey DE, et al. 2010 ACCF/AHA/AATS/ACR/ASA/SCA/SCAI/ SIR/STS/SVM Guidelines for the diagnosis and management of patients with thoracic aortic disease. Anesth Analg 2010;111:279-315. Erbel R, Aboyans V, Boileau C, Bossone E, Di Bartolomeo R, Eggebrecht H, et al. 2014 ESC guidelines on the diagnosis and treatment of aortic diseases. Eur Heart J 2014;35: 2873-926. Czerny M, Schmidli J, Adler S, van den Berg JC, Bertoglio L, Carrel T, et al. Editor’s choicedcurrent options and recommendations for the treatment of thoracic aortic pathologies involving the aortic arch: an expert consensus document of the European Association for Cardio-Thoracic Surgery (EACTS) & the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg 2019;57:165-98. D’Agostino RS, Jacobs JP, Badhwar V, Fernandez FG, Paone G, Wormuth DW, et al. The Society of Thoracic Surgeons Adult Cardiac Surgery Database: 2019 update on outcomes and quality. Ann Thorac Surg 2019;107:24-32. Andersen ND, Williams JB, Hanna JM, Shah AA, McCann RL, Hughes GC. Results with an algorithmic approach to hybrid repair of the aortic arch. J Vasc Surg 2013;57:655-67.
Submitted Jul 15, 2019; accepted Nov 5, 2019.
ABSTRACT Objective: Aortic arch aneurysmal disease remains a therapeutic challenge. For patients unsuitable for standard open surgery, hybrid repair with debranching of the supra-aortic arteries followed by thoracic endovascular grafting has been shown to be an effective solution. The aim of this study was to report the clinical outcomes of a single-institution experience using hybrid aortic arch repair. Methods: The cases of all consecutive patients submitted to hybrid aortic arch repair between January 2010 and June 2018 were prospectively collected and retrospectively analyzed. The outcomes of the study were 30-day mortality, perioperative complications, 2-year survival, endoleak, and reintervention rates. Results: A total of 35 patients with a median age of 71 years (interquartile range, 62-77 years) were submitted to hybrid aortic arch repair, with a median follow-up of 26.9 months (interquartile range, 2.4-63.6 months). Ten procedures (28.6%) were performed urgently for contained rupture. The most common etiology was degenerative (n ¼ 14 [40.0%]). The proximal landing zones according to the Ishimaru classification were zone 2 in 20 patients (57.1%), zone 1 in 12 patients (34.3%), and zone 0 in 3 patients (8.6%). Early endoleaks were observed in six patients (17.1%), equally distributed between type I and type II. Late endoleaks were identified in 4 of 24 patients (16.7%; type I, n ¼ 2 [8.3%]; type II, n ¼ 1 [4.2%]; and type III, n ¼ 1 [4.2%]). Thirty-day mortality rate was 14.3% (n ¼ 5) with an early death rate of 8.7% (2/23) in elective cases and 30.0% (3/10) in urgent cases (odds ratio [OR], 4.93; confidence interval [CI], 0.68-35.67; P ¼ .128). Except in one patient, 30-day mortality was associated with landing zone 0 or zone 1 (26.7% vs 5.0%; OR, 6.91; CI, 0.68-69.86; P ¼ .141). Three patients (8.6%) suffered a postoperative stroke, and no episodes of spinal cord ischemia were observed. Two-year survival rate was 67.8% (CI, 49.4%-80.8%). Survival rates were significantly lower with increasing age (hazard ratio [HR], 1.10; CI, 1.03-1.18; P ¼ .004), urgent procedure (HR, 4.80; CI, 1.56-14.80; P ¼ .003), zone 0 or zone 1 (HR, 6.34; CI, 1.73-23.18; P ¼ .001), presence of arrhythmia (HR, 3.76; CI, 1.22-11.62; P ¼ .013), and cerebrovascular disease (HR, 4.12; CI, 1.38-12.35; P ¼ .006). A multivariate analysis identified age (HR, 1.11; P ¼ .047) and zone 0 or zone 1 (HR, 4.93; P ¼ .033) as the only predictors for overall mortality. Conclusions: Hybrid aortic arch repair seems to be an alternative for higher risk patients not suitable for open repair, but selection of patients is crucial and may benefit from further refinement. In this study, worse outcomes were seen in older patients and those who required more proximal landing zones. (J Vasc Surg 2020;-:1-9.) Keywords: Aortic arch; Endovascular procedures; Multimorbidity; Stroke; Spinal cord ischemia
Aortic arch aneurysmal disease remains a challenge for the contemporary surgeon.1 Open repair is the “gold standard” approach for the management of aortic arch aneurysms. However, it may require hypothermic circulatory arrest and cardiopulmonary bypass,2-4 and many patients
From the Vascular Surgery Service, Heart and Vessels Department, Hospital Santa Maria (CHULN)a; the Lisbon Academic Medical Centreb; and the Faculty of Medicine, University of Lisbon.c Author conflict of interest: none. Correspondence: Tony R. Soares, MD, Hospital de Santa Maria, Centro Hospitalar Universitário Lisboa Norte, EPE, Serviço de Angiologia e Cirurgia Vascular, Avenida Professor Egas Moniz, 1649-035 Lisboa, Portugal (e-mail: [email protected]). The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. 0741-5214 Copyright Ó 2019 by the Society for Vascular Surgery. Published by Elsevier Inc. https://doi.org/10.1016/j.jvs.2019.11.033
will not benefit from the open surgical treatment because of their frail condition and associated comorbidities.2-4 Endovascular technology has prompted new solutions to the approach to the aortic arch, expanding the treatment to higher risk patients considered otherwise poor candidates for open repair. In 2001, Ishimaru proposed an anatomic landing zone classification to indicate the proximal deployment site of the endograft, making it possible to standardize the types of debranching and to evaluate the indications for treatment as well as to compare results.5 The use of endografts in the aortic arch implies rerouting of the supra-aortic trunks, and the combination of these two concepts is known as hybrid surgery. These hybrid procedures take advantage of the best of both worlds, using open and endovascular techniques to overcome each one’s major limitations, and hybrid surgery has been shown to provide a successful treatment alternative for otherwise untreatable patients. 1
2
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The aim of this study was to report the early and midterm clinical outcomes of hybrid aortic arch repairs performed in a single institution for high-risk patients deemed unfit for open surgery, thus providing information from real-world experience with this approach.
ARTICLE HIGHLIGHTS d
d
METHODS Study design and patient population. Within the framework of the Heart and Vessels Department, a patient-tailored approach for the management of aortic arch aneurysms according to their clinical status was provided, and each patient was assessed in a multidisciplinary meeting involving vascular surgery, cardiothoracic surgery, cardiology, and anesthesiology teams. A preliminary evaluation, with full history and physical examination, blood analysis, 12-lead electrocardiography, radiography, and echocardiography, was performed for all patients. After this assessment, patients considered for open surgery were individually evaluated with coronary angiography, exercise stress testing for myocardial ischemia, and pulmonary function tests according to the multidisciplinary team. All criteria used for the surgical planning process were relative factors and did not serve as absolute indications for or contraindications to open surgery or hybrid aortic arch repair. Advanced age, frailty, significant comorbidities such as cardiac disease (eg, nonrevascularized coronary disease, heart failure), severe pulmonary function failure, history of stroke, chronic kidney disease, and history of sternotomy or patients who refused open surgery were relevant factors favoring hybrid aortic arch repair. However, the multidisciplinary team made the final decision after all these factors were considered. Patients considered fit for open surgery were referred to the Cardiothoracic Surgery servicedabout 10 to 15 patients a year. All the patients accepted for hybrid aortic arch repair were treated by the Vascular Surgery service. This study was conducted as a retrospective, noncomparative, single-center analysis of prospectively collected data of hybrid arch procedures performed in a tertiary academic hospital. The cases of all consecutive patients submitted to hybrid aortic arch repair between January 2010 and June 2018 were prospectively collected until December 2018. Patients submitted to full open surgery or pure endovascular procedures (ie, total endovascular arch repair with chimney techniques or branched arch endografts) were excluded, as were patients treated with frozen elephant trunk techniques. Demographic and study data were obtained from hospital medical records. All patients provided informed consent before treatment, and Institutional Review Board approval was waived for this study. Procedures. All patients were preoperatively evaluated by computed tomography angiography for endograft planning. Landing zones of at least 20 mm in length,
2020
d
Type of Research: Retrospective review of prospectively collected single-center data. Key Findings: Thirty-five patients with aortic arch aneurysms unsuitable for open surgery were submitted to hybrid aortic arch repair. The 30-day mortality and stroke rates were 14.3% and 8.6%, respectively, without spinal cord ischemia, and 2-year survival was 67.8%. Increased age and proximal landing zones were independent predictors of overall mortality. Take Home Message: Hybrid aortic arch repair is a valid option for higher risk patients; advanced age and need of more proximal landing zones are associated with worse outcomes.
with a proximal oversizing of 10% to 15% in dissections and 15% to 20% in degenerative aneurysms, were selected. The endograft choice was based on aortic arch morphologic and pathologic features as well as the surgeon’s preference. All procedures were performed in the operating room using the portable BV 300 C-arm (Philips Medical Systems, Eindhoven, The Netherlands) before 2016 and the Veradius Unity mobile C-arm system (Philips Medical Systems) after 2016. The facility lacks a hybrid operating room with a fixed imaging system. The patients were operated on under general anesthesia with intraoperative anticoagulation with unfractionated heparin (in general, 2500 units before clamping for debranching procedures; further doses of heparin were administered as needed to achieve an activated clotting time of 250 seconds or longer during deployment of the endovascular graft). Preoperative cerebrospinal fluid (CSF) drainage was selectively used in patients with higher risk for spinal cord ischemia (SCI; >200 mm of expected covered length of the aorta, endograft covering of the thoracoabdominal transition, previous abdominal aortic surgery, or hypogastric artery disease). The first patients were monitored by transcranial Doppler during the procedures. However, because it was difficult to differentiate air embolization from solid embolic material, we decided not to use it routinely, considering that no relevant information was provided by the technique. Total supra-aortic vessel debranching was performed with bypass grafting from the ascending aorta through a ministernotomy. For zone 1, patients were submitted to extra-anatomic right common carotid artery (RCCA)left common carotid artery (LCCA)-left subclavian artery (LSA) bypass or RCCA-LSA graft with reimplantation of the LCCA with subsequent ligation or embolization of the proximal LSA. LSA revascularization for Ishimaru zone 2 was performed with LCCA-LSA bypass or LSA to LCCA transposition. The vascular access was obtained
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by femoral cutdown. In selected cases, precise endograft positioning was obtained with rapid pacing or partial right atrial inflow occlusion using a compliant occlusion balloon in the inferior vena cava. Open and endovascular procedures were performed either synchronously or staged. A single-stage procedure was generally the preferred approach; however, it requires longer operative times and increased blood loss, which is more stressful for the patient and the surgical team. Therefore, the choice between staged and simultaneous procedures was at the discretion of the surgeon. All emergent patients underwent a single-stage procedure. Follow-up. Postoperative computed tomography angiography was routinely performed before discharge, at 6 and 12 months postoperatively, and afterward on a yearly basis. In addition, all patients underwent clinical examination and regular duplex ultrasound evaluation of the supra-aortic reconstruction. Study end points. The end points for the study were 30-day mortality, 2-year survival rates, postoperative complications, and endoleak and reintervention rates. Perioperative or early events were defined as occurring within the first 30 postoperative days; late events occurred after 30 days. Statistical analysis. A retrospective analysis of prospectively collected data was performed. Continuous variables were presented as median with interquartile range (IQR) from 25th to 75th percentile and compared between groups using the Mann-Whitney U test. Categorical variables were presented by absolute numbers with percentage values and compared between groups using the Fisher exact test. Time-to-event end points were described using Kaplan-Meier estimates. Survival curves were compared using log-rank tests for categorical predictors. Odds ratio (OR) and hazard ratio (HR) with 95% confidence intervals (CIs) were estimated with logistic regression and univariate Cox analysis, respectively. The Cox proportional hazards model was used to determine independent predictors of death. The proportional hazard assumption was assessed with Schoenfeld residuals. All analyses were considered statistically significant if a two-tailed P value < .05 was observed. Statistical analysis was carried out using Stata 12.1 (StataCorp LP, College Station, Tex).
RESULTS Patient and procedural characteristics. A total of 35 patients were submitted to hybrid aortic arch repair with debranching of the supra-aortic arteries followed by thoracic endovascular aortic repair (TEVAR). The majority of the patients were male (85.7%; 30 male, 5 female), with a median age of 71 years (IQR, 62-77 years), and 40% of the population were older than 75 years. Six patients (17.1%) had a history of sternotomy, having been
Table I. Demographic characteristics and comorbidities Demographics Patients
Total (N ¼ 35) 35
Age, years
71 (62-77)
Male
30 (85.7)
Risk factors Smoking history
20 (57.1)
Active smoker
10 (28.6)
Former smoker
10 (28.6)
Diabetes mellitus
13 (37.1)
Hypertension
29 (82.9)
Coronary artery disease
13 (37.1)
Dyslipidemia
20 (57.1)
Chronic kidney disease
8 (22.9)
Cerebrovascular disease
8 (22.9)
Arrhythmia
7 (20.0)
Thoracosternotomy
6 (17.1)
Categorical variables are presented as number (%). Continuous variables are presented as median (interquartile range).
submitted primarily to procedures such as Mustard surgery, Bentall procedure, repair of coarctation of the aorta, coronary artery bypass grafting, and aortic valve replacement. Demographic characteristics with comorbidities are presented in Table I. Ten procedures (28.6%) were performed urgently for contained rupture. Indications for treatment and other intraoperative characteristics are reported in Table II. The most common cause was degenerative aneurysm (n ¼ 14 [40.0%]), followed by chronic dissection with aneurysmal degeneration (n ¼ 7 [21.2%]), chronic post-traumatic aneurysm (n ¼ 7 [20.0%]), pseudoaneurysm (n ¼ 3 [8.6%]), type I endoleak (n ¼ 2 [5.7%]), acute dissection with malperfusion syndrome (n ¼ 2 [5.7%]), and chronic dissection with symptomatic extreme collapse of the true lumen (n ¼ 1 [2.9%]). The proximal landing zones according to the Ishimaru classification were zone 2 in 20 patients (57.1%), zone 1 in 12 patients (34.3%), and zone 0 in 3 patients (8.6%). The detailed debranching procedures are described in Table III. The pretracheal route was used for RCCALCCA bypass in all but one case, in which a retroesophageal position was chosen. Eighteen (51.4%) hybrid procedures were staged, all in the emergent patients submitted to a single-stage intervention. Endografts were predominantly Zenith Alpha or TX2 (n ¼ 29 [82.9%]; Cook Medical, Bloomington, Ind), followed by Gore TAG Conformable Thoracic Stent Graft (n ¼ 3 [8.6%]; W. L. Gore & Associates, Flagstaff, Ariz), Valiant (n ¼ 2 [5.7%]; Medtronic, Santa Rosa, Calif), and JOTEC (n ¼ 1 [2.9%]; JOTEC GmbH, Hechingen, Germany). Deliberate hypotension for precise endograft deployment was used in 17.1% (n ¼ 6) of cases (rapid
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Table II. Intraoperative characteristics Variables
Total (N ¼ 35)
Table III. Surgical procedures according to Ishimaru zones Debranching intervention
Procedure status Urgent Elective
10 (28.6)
Zone 0
Ascending aortic debranching
25 (71.4)
Zone 1
RCCA-LCCA-LSA
Diagnosis Degenerative aneurysm
14 (40.0)
Chronic dissection with aneurysmal degeneration
7 (20.0)
Chronic post-traumatic aneurysm
6 (17.1)
Pseudoaneurysm
3 (8.6)
Acute dissection
2 (5.7)
Type I endoleak Chronic dissection Intraoperative lumbar spinal fluid drainage Aortic coverage, mm Staged procedures
2020
Zone 2
No. (%) 3 (9.1) 10 (30.3)
RCCA-LSA þ LCCA reimplantation
1 (3.0)
LCCA-LSA þ left VA reimplantation (bovine aortic arch)
1 (3.0)
LCCA-LSA
16 (45.7)
LSA to LCCA transposition
2 (6.1)
LCCA-LSA þ left VA reimplantation
2 (6.1)
2 (5.7) 1 (2.9)
Total
21 (61.8)
35 (100)
LCCA, Left common carotid artery; LSA, left subclavian artery; RCCA, right common carotid artery; VA, vertebral artery.
201 (156-300) 18 (51.4)
Categorical variables are presented as number (%). Continuous variables are presented as median (interquartile range).
pacing in five patients and partial venous inflow occlusion of the inferior vena cava in one patient). Preventive CSF drainage was performed the day before surgery in 61.8% (n ¼ 21) of the patients. Perioperative outcomes. Perioperative complications are presented in Table IV. Three patients (8.6%) suffered a postoperative stroke, one in the posterior territory without sequelae. In two patients, stroke was associated with in-hospital death (one case involving the anterior circulation and another involving both territories). All stroke patients were previously submitted to LSA revascularization. No episodes of SCI were observed. The overall 30-day mortality was 14.3% (n ¼ 5), which led to a 30-day mortality of 8.7% (2/23) for elective cases and 30.0% (3/10) for urgent cases. Of these five deaths, four occurred in patients with landing zone 0 or zone 1. Deaths were due to ischemic stroke (n ¼ 2), sepsis after esophageal fistula and infection of the retroesophageal graft (n ¼ 1), multiorgan failure (n ¼ 1), and hemorrhagic shock in a patient submitted to total supra-aortic debranching with perianastomotic bleeding in the ascending aorta (n ¼ 1). In addition, five deaths were observed within 6 months of surgery; two of them were in-hospital death with multiorgan failure as the cause (Table V). There was no significant difference in the outcomes between simultaneous repair and staged repair. The 30-day mortality rate was 11.8% (2/15) for simultaneous repair and 16.7% (3/15) for staged repair (OR, 0.67; CI, 0.10-4.58; P ¼ .528). The rate of early stroke was 5.9% (1/17) for simultaneous repair and 11.1% (2/18) for staged repair (OR, 0.50; CI, 0.04-6.08; P ¼ .522).
Stroke was not related to age (OR, 1.07 per year; CI, 0.95-1.21; P ¼ .254), proximal landing zone (OR, 1.38; CI, 0.17-11.15; P ¼ 1.000), urgent procedure (OR, 0.81; CI, 0.07-8.91; P ¼ 1.000), or previous cerebrovascular disease (OR, 1.14; CI, 0.10-12.78; P ¼ 1.000). Endoleaks, reinterventions, and late follow-up outcomes. The median follow-up was 26.9 (IQR, 2.4-63.6) months, with a 2-year survival rate of 67.8% (CI, 49.4%80.8%). Causes of death are presented in Table V. Two deaths were related to rupture of aortic aneurysm. One patient with a concomitant type IV thoracoabdominal aneurysm was intended to be treated soon after complete recovery from the aortic arch repair. However, the thoracoabdominal aneurysm ruptured 2.4 months after aortic arch hybrid repair. The other patient was in a close follow-up program because of an abdominal aortic aneurysm with 5-cm diameter and was admitted with a rupture 4 years later. Seven patients (20.0%) underwent aorta-related reinterventions, and three of them were submitted to open surgery (Table VI). Early endoleaks were observed in six patients (17.1%), equally distributed between type I (n ¼ 3 [8.6%]) and type II (n ¼ 3 [8.6%]). Late endoleaks were identified in 4 of 24 patients (16.7%; type I, n ¼ 2 [8.3%]; type II, n ¼ 1 [4.2%]; and type III, n ¼ 1 [4.2%]), but 11 patients were excluded (10 deaths occurred before the 6-month computed tomography scan, and one patient was recently treated <6 months). All type I endoleaks, early and late, were successfully treated, except in one patient waiting for a suitable custom-made endograft. The only type III endoleak was successfully treated with an additional TEVAR. Additional details are shown in Fig 1. Endoleak rates, early and late, were not related to proximal landing zone (OR, 2.83; CI, 0.55-14.47; P ¼ .192), urgent procedure (OR, 1.71; CI, 0.32-9.11; P ¼ .411), or age (OR, 1.02; CI, 0.95-1.10; P ¼ .409).
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Table IV. Complications
Table V. Causes of death
Complications
No. (%)
Cause of death
Time
No. (%)
Stroke
3 (8.6)
Pneumonia
2.4 months
1 (2.9)
a
Transient renal dysfunction
3 (8.6)
Hemothorax
10 days
1 (2.9)
Cervical hematomaa,b
2 (5.7)
2.4 months
1 (2.9)
Pneumonia
1 (2.9)
Type IV thoracoabdominal aneurysm rupture
Venous thromboembolismb
1 (2.9)
58.1 months
1 (2.9)
Left CCA stenosis (endograft maldeployment)
1 (2.9)
Abdominal aortic aneurysm rupture Septic shock (esophageal fistula with graft infection)
27 days
1 (2.9)
Cardiogenic shock
1.2 months
1 (2.9)
Stroke
2 days
2 (5.7)
Tracheostomy
c
SCI
1 (2.9) 0 (0.0)
CCA, Common carotid artery; SCI, spinal cord ischemia. a Complications of transient renal dysfunction and cervical hematoma occurred in the same patient. b Complications of cervical hematoma and venous thromboembolism occurred in the same patient. c Complication of tracheostomy and pneumonia occurred in the same patient.
16 days Multiorgan failure
DISCUSSION Aortic arch repair is associated with a substantial perioperative risk regardless of the type of procedure chosen. Outcomes of open surgery have been improving with the introduction of new techniques and surgical refinements in circulatory management and cerebral protection.6,7
3 (8.6)
3.2 months 2.3 months Unknown cause
Determinants of mortality. Patients who died in the perioperative period had a median age of 76 years (IQR, 73-77 years) as opposed to 69 years (IQR, 61-77 years) for the surviving patients (OR, 1.06; CI, 0.95-1.18; P ¼ .346). Of the five perioperative deaths, four occurred in patients with landing zone 0 or zone 1 (4/15 [26.7%]) vs zone 2 (1/20 [5.0%]; OR, 6.91; CI, 0.68-69.86; P ¼ .141). Perioperative mortality rate was 8.7% (2/23) in elective cases and 30% (3/10) in urgent cases (OR, 4.93; CI, 0.68-35.67; P ¼ .128). Survival rates were significantly lower in urgent procedures (HR, 4.80; CI, 1.56-14.80; P ¼ .003), with a 2-year survival rate of 84.0% (CI, 63.8-93.7) in elective cases and 23.3% (CI, 3.6-52.9) in urgent ones. Those patients in whom landing zone 0 or zone 1 was used had a higher mortality (HR, 6.34; CI, 1.73-23.18; P ¼ .001), with 2-year survival rates of 40.0% (CI, 16.5-62.8) when proximal deployment was in zone 0 or zone 1 vs 89.4% (CI, 63.8-97.3) when zone 2 was feasible (Fig 2). Reduced survival rate was significantly associated with age (HR, 1.10; CI, 1.03-1.18; P ¼ .004), presence of arrythmia (28.6% [CI, 4.161.2] vs 78.1% [CI, 57.26-89.5]; HR, 3.76; CI, 1.22-11.62; P ¼ .013), and cerebrovascular disease (37.5% [CI, 8.767.4] vs 77.0% [CI, 55.7-89.0]; HR, 4.12; CI, 1.38-12.35; P ¼ .006). The remaining risk factors and patient characteristics were not statistically significant. In a multivariate analysis, age (HR, 1.11; CI, 1.00-1.23; P ¼ .047) and proximal landing in zone 0 or zone 1 (HR, 4.93; CI, 1.14-21.32; P ¼ .033) were the only predictors for overall mortality. Urgent treatment, sex, and presence of arrhythmia or cerebrovascular disease were not significantly associated with overall mortality.
25 days
43.2 months
2 (5.7)
7.0 months Total
e
13 (37.1)
However, for higher risk patients unsuitable for open surgery, less invasive procedures such as hybrid repair might be the only viable option. This study evaluated a real-world single-center series with an overall 30-day mortality rate of 14.7%, a stroke rate of 8.6%, and no SCI. Previously published studies showed perioperative mortality rates ranging from 3.7% to 20%,1,8-14 apparently higher in those series with more urgent cases (19.6%-27.3%), in which reported perioperative mortality ranged between 9.8% and 20.4%, as listed in Table VII, which is in agreement with our findings. This study reported 28.6% of patients treated urgently with a perioperative mortality rate of 30.0% vs 8.7% for elective cases. Previous literature had already pointed out how urgent cases resulted in worse outcomes.9,14 We did not obtain a statistically significant difference for perioperative mortality rates between urgent and elective patients, probably related to the limited sample size. However, we did observe a significant decrease in the overall survival rate of patients treated urgently. Several trials comparing hybrid aortic arch repair with open surgery outcomes reported inconclusive results, mostly because of selection bias related to patients’ risk profiles.2,9,15,16 However, there is some evidence of comparable outcomes between the two approaches when a risk stratification was performed. In a propensity score-matched analysis, 337 patients submitted to open surgery were compared with 58 patients treated by a hybrid approach, obtaining 43 matched pairs.3 Compared with open surgery, hybrid aortic arch repair was associated with similar perioperative mortality rates and midterm outcomes but with higher incidence of stroke.3
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Table VI. Endoleaks and other complications with subsequent reinterventions No.
Ishimaru zone
4
Zone 0
Early endoleak
Late endoleak
e
e
Postoperative complication Hemothorax related to bleeding from ascending aorta proximal to debranching (hemorrhagic shock)
Reintervention Emergent exploratory sternotomy and hemostatic sutures at 10 days
8
Zone 2
e
Type III
13
Zone 1
Type II
e
TEVAR at 17.8 months
14
Zone 1
e
Type I
Chimney TEVAR; chimney for BCT at 20 months
21
Zone 1
Type I
e
Chimney TEVAR; chimney for BCT at 7 days
24
Zone 2
e
e
LCCA stenosis (endograft maldeployment)
Right subclavian-LCCA bypass at 1.6 months
31
Zone 1
Type I (1)
e
Wound infection (2)
Wrapping of the ascending aorta at 5 days Substitution of Dacron debranching by venous grafts at 20 days
LSA embolization at 1.0 month
BCT, Brachiocephalic trunk; LCCA, left common carotid artery; LSA, left subclavian artery; TEVAR, thoracic endovascular aortic repair.
Fig 1. Diagram of endoleaks and subsequent reinterventions. BCT, Brachiocephalic trunk; CT, computed tomography; SCA, subclavian artery; TEVAR, thoracic endovascular aortic repair.
Cerebrovascular events are one of the major drawbacks of endovascular techniques approaching the aortic arch.17 Series similar to this study reported rates of stroke ranging from 3% to 29%1,3,9-14 (Table VII). A systematic review and meta-analysis suggested that the stroke incidence is higher if the LSA is covered without revascularization during TEVAR (pooled stroke incidence of 8.0% if the LSA is covered without revascularization vs 5.3% if the LSA is covered but revascularized vs 3.2% when the LSA is uncovered),18 thus supporting a policy for subclavian revascularization as adopted in our practice. In addition, some centers are exploring other methods to prevent these complications, such as the use of carbon dioxide to flush aortic stent grafts.17
Paraplegia, another devastating neurologic complication of thoracic and thoracoabdominal aortic repair, has dramatic repercussions on the patient’s quality of life and is an important factor in reduced long-term survival.19-21 Previous series of hybrid aortic arch repair reported rates of SCI up to 7.4%, with an average covered aortic length between 136 and 230 mm.1,8,10-12,14 The role of CSF drainage is unclear. Canaud et al14 did not use it prophylactically and had a rate of paraplegia of 4.5% with a mean length of covered aorta of 180 mm. Melissano et al12 performed CSF drainage in all cases with a planned coverage of the descending thoracic aorta >200 mm, previous abdominal aortic repair, or covering of critical intercostal arteries, reporting 2.1% SCI in a
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Fig 2. Kaplan-Meier analysis of (A) overall survival and according to (B) urgent procedures and (C) proximal landing zones
population of 143 patients. However, the aortic coverage length was not reported. Despite a median covered aortic length of 201 mm, we observed a remarkable outcome with no cases of paraparesis or paraplegia. This result could be related to the adopted program for SCI prevention with high rates of preoperative CSF drainage, permissive hypertension (median arterial pressure $80 mm Hg), hemoglobin level $10 g/dL, and preservation of the LSA and the hypogastric arteries. However, some authors did not perform preventive CSF drainage, reserving it for SCI occurrence, which may explain their increased rates of SCI.4,14 This passive approach could have some advantages, such as decreasing the risk of severe complications like epidural hematoma and meningitis with pooled rate estimates of 1.7% and 0.1%, respectively.21 However, CSF drainage is
the only preventive measure supported by a randomized trial22 and by U.S. guidelines (class IB) and European guidelines (class IIB).23,24 We do recommend an aggressive protocol to prevent SCI. Our midterm survival rated67.8% for 2 yearsdis comparable to that of other series with similar high rates of urgent cases in their population (ie, w30%): Hiraoka et al9 with a 3-year survival rate of 63.9%, Lotfi et al11 with a 2-year survival rate of 73%, and Canaud et al14 with an overall survival rate of 70%. Whereas our results were comparable to those in the literature, we recognize that 28.6% of our population have died in the first 6 months; therefore, selection of patients may benefit from further refinement. However, we are dealing with a highrisk subgroup difficult to stratify because of the absence of the appropriate tools to assess perioperative risk. The
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Table VII. Outcomes of hybrid aortic arch repair in other series: Literature review Stroke, %
CSF drainage, %
SCI, %
Survival, %
7.4
e
7.4 (permanent)
85.9 (2 years)
28.6
e
2.9
63.9 (3 years)
No.
Murashita et al8 (2012)
27
0
Hiraoka et al9 (2015)
35
25.7
De Rango et al1 (2014)
104
6.7
29.2 (mean)
5.8 (total)
3.8
2.9
4.8 (total) 2.9 (permanent)
89.0 (1 year) 82.8 (3 years)
Chiesa et al10 (2014)
179
e
27.3 (mean)
4.5 (total)
3.4
e
1.1 (permanent)
e
51
19.6
15 (mean)
9.8 (total) 4.9 (elective) 30.0 (urgent)
11.8
e
5.9 (total) 3.9 (permanent)
Melissano et al12 (2012)
143
e
4.2 (total)
2.8
21.7
2.1
e
Schumacher et al13 (2006)
25
32
21 (mean)
20.0 (total)
4.0
0
e
Canaud et al14 (2010)
44
27.3
29.9 (mean)
20.4 (total) 15.6 (elective) 33.3 (urgent)
6.8
0
4.5 (total) 2.3 (permanent)
Current study
35
28.6
26.9 (median)
14.3 (total) 8.7 (elective) 30.0 (urgent)
8.6
61.8
0
Author (year)
Lotfi et al11 (2013)
Follow-up, months
30-day mortality, %
Urgent, %
7 (median) e
e
0 14.3 (total) 7.7 (elective) 33.3 (urgent)
78 (1 year) 73 (2 years)
70 (overall)
67.8 (2 years)
CSF, Cerebrospinal fluid drainage; SCI, spinal cord ischemia.
well-known European System for Cardiac Operative Risk Evaluation (EuroSCORE I and II) and the Society of Thoracic Surgeons Predicted Risk of Mortality were validated for cardiac surgery but not for aortic diseases. A recent expert consensus recognized that these scores and other severity scores are inappropriate risk prediction tools for this population in particular.25 To surpass this situation, the Society of Thoracic Surgeons Task Force on Aortic Surgery rewrote the sections concerning the aortic arch and thoracic aortic surgery to reflect new surgical techniques.25,26 It is clear that proximal aortic arch repair is associated with worse outcomes,1,2,9,12,27 and our results were in agreement, confirming a 2-year-survival rate of 89.4% in zone 2 compared with 40.0% in zone 0 and zone 1. In fact, a multivariate analysis identified proximal landing zone and age as the only predictors for overall mortality in our study. Benrashid et al2 reported an institutional shift away from zone 0 hybrid aortic arch repair after their previous results with high mortality rates in proximal landing zones. However, in this study, some patients requiring the use of zone 0 and zone 1 also had a prohibitive risk for open surgery, which led us to seek other viable options.
The study of Benrashid et al2 is also relevant because the authors followed a patient selection policy similar to our institution’s, achieving lower long-term survival outcomes in the hybrid higher risk group compared with the lower risk patients treated by open surgery. However, the aorta-related survival was similar in both groups, which favors the careful selection policy between open and hybrid interventions that we also follow in our center. We acknowledge some limitations in the study. This is a single-center retrospective analysis, without a comparative group, and with some heterogeneity of patients regarding disease of the aorta.
CONCLUSIONS The aortic arch is one of the most challenging territories for endovascular techniques, and fit patients are still selected for open surgery. Hybrid aortic arch repair seems to be a valid alternative to open surgery and allows the treatment of higher risk patients, but selection of patients is crucial and may benefit from further refinement. In our “real-world” study, survival was independently reduced by age and patients requiring more proximal landing zones.
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AUTHOR CONTRIBUTIONS Conception and design: TS, LP Analysis and interpretation: TS, RM, PA, AM, GS, LS, RFeF, CM, JFeF, LP Data collection: TS, LP Writing the article: TS, LP Critical revision of the article: TS, RM, PA, AM, GS, LS, RFeF, CM, JFeF, LP Final approval of the article: TS, RM, PA, AM, GS, LS, RFeF, CM, JFeF, LP Statistical analysis: TS Obtained funding: Not applicable Overall responsibility: LP
14.
15.
16.
17.
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Submitted Jul 15, 2019; accepted Nov 5, 2019.