- Email: [email protected]
Endovascular Treatment of Descending Thoracic Aortic Pathology: Results of the Regis-TEVAR Study
Clinical Research Endovascular Treatment of Descending Thoracic Aortic Pathology: Results of the Regis-TEVAR Study Cristina Lopez Espada,1 Jose Patricio Linares Palomino,1 Jose Manuel Domı´nguez Gonzalez,2 Elena Iborra Ortega,3 Pascual Lozano Vilardell,4 Teresa Solanich Valldaura,5 Guido Volo Perez,6 Estrella Blanco Ca~ nibano,7 Andres Alvarez Salgado,8 9 Juan Carlos Fern andez Fern andez, Manuel Hernando Rydings,10 and Manuel Miralles Hern andez,11 Spain
Background: Endovascular techniques have become an essential tool for treatment of thoracic aortic pathology. The objective of this study was to analyze indications and results of thoracic endovascular aortic repair (TEVAR) in vascular surgery units, through a retrospective and multicentric national registry called Regis-TEVAR. Methods: From 2012 to 2016, a total of 287 patients from 11 vascular surgery units, treated urgently and electively, were recruited consecutively. The primary variables analyzed are mortality, survival, and reintervention rate. The following indications for TEVAR were also analyzed: aortic dissections, thoracic aneurysms, traumatisms, and intramural hematomas or penetrating ulcers, as well as results and postoperative complications in accordance with each indication. Results: Of the 287 TEVAR performed (239 men, mean age 64.1 ± 14.1 years), 155 were because of aortic aneurysm (54%), 90 because of type B aortic dissection (31.4%), 36 because of traumatic aortic rupture (12.5%), and 6 because of penetrating ulcers or intramural hematomas (2.1%). Overall mortality at 30 days was 11.5% (18.5% in urgent and 5.3% in elective), being higher in dissections (13.3%). The median actuarial survival was 73% at 4 years. The stroke rate was 3.1%, and the rate of spinal cord ischemia was 4.9%. Aortic reoperations were necessary in 23 patients (8.1%). Conclusions: This registry provides complete and reliable information on real clinical practice of TEVAR in Spain, with results similar to international series of open surgery. In accordance with these data, TEVAR can be performed with acceptable morbidity and mortality and with low rates of postoperative complications.
1 Vascular Surgery Unit, University Hospital Virgen de las Nieves of Granada, Spain. 2
Vascular Surgery Unit, University Hospital Vall d’Hebron of Barcelona, Spain. 3 Vascular Surgery Unit, University Hospital Bellvitge of Barcelona, Spain. 4
Vascular Surgery Unit, University Hospital Son Espases Palma de Mallorca, Spain. 5 Vascular Surgery Unit, Corporacio Sanitaria Parc Tauli de Sabadell, Spain. 6
Vascular Surgery Unit, University Hospital Dr.Negrı´n de Gran Canaria, Spain. 7
Vascular Surgery Unit, University Hospital Guadalajara, Spain.
8
Vascular Surgery Unit, University Hospital Cabue~ nes, Spain.
9
Vascular Surgery Unit, Hospital de Galdakao, Spain.
10
Vascular Surgery Unit, University Hospital Basurto, Spain. Vascular Surgery Unit, University Hospital La Fe Valencia, Spain.
11
Correspondence to: Cristina Lopez Espada, Coordinator of the RegisTEVAR Collaborative Group, Vascular Surgery Unit University Hospital Virgen de las Nieves, Avenue De las Fuerzas Armadas, 2, 18014 Granada, Spain; E-mail: [email protected] Ann Vasc Surg 2020; -: 1–10 https://doi.org/10.1016/j.avsg.2020.02.012 Ó 2020 Elsevier Inc. All rights reserved. Manuscript received: October 24, 2019; manuscript accepted: February 6, 2020; published online: - - -
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2 Lopez Espada et al.
INTRODUCTION The techniques for thoracic endovascular aortic repair (TEVAR) have revolutionized in recent years the treatment of patients with different pathologies: type B dissections (TBAD), descending thoracic aortic aneurysms (DTAA), traumatic thoracic aortic injuries (TAI), intramural hematomas (IMH), penetrating aortic ulcers (PAU), and so on. TEVAR consists in implanting a stent graft by means of femoral access, with the aim of excluding such lesions. A priori, these are less invasive techniques than conventional open surgery, which leads to lower morbidity and mortality.1 Globally accumulated evidence shows that TEVAR can reduce mortality, paraplegia, and the overall rate of complications, compared with open surgery (OR),2e4 which it has made the procedure of choice in high-risk patients and in a critical situation. In Spain, it was deployed for the first time in 1995,5 and since then, the expansion has been spectacular, requiring a review of its indications, complications, and limitations of a technique that has been adopted by multiple specialties including cardiologists, cardiac surgeons, radiologists, and vascular surgeons. The aim of this observational study was to analyze the indications and the results of TEVAR, through the data obtained from a national multicenter registry. This is the first publication of a Spanish registry of patients treated by TEVAR.
MATERIALS AND METHODS Study Design The Regis-TEVAR study is a retrospective and multicentric national registry in angiology and vascular surgery units in Spain. It comprised 5 years of inclusion from January 2012 to December 2016. The Spanish Endovascular Chapter and the Spanish Society of Vascular Surgery sponsored the creation of a voluntary database, where the clinical units could provide information about their practice in the TEVAR. They were invited to participate through the forums of scientific diffusion of our scientific society and 11 clinical units accepted. The registry was carried out independently of the industry and supported by the interest of the vascular society. In 2017, the database used was validated by the Vascunet, a European working group for the collaboration of international vascular registries, administered and funded by the European Society of Vascular Surgery. This working group was established to improve the quality, safety, and efficiency of vascular care in Europe and Australia.
Annals of Vascular Surgery
The data have been collected by physicians in charge of the patient, together with the approval from the ethics institutional review board, to participate in this registry and obtained locally in each institution. The database includes 4 sections: preoperative demographic data with 9 variables, specific data as per the clinical indication with 13 variables, intraoperative data with 17 variables, and postoperative data with 16 variables (see Table I). The proximal and distal landing zones were based on the classification by Fillinger et al.6 (see Figs. 1 and 2). Data such as femoral access type (percutaneous vs. open), use of ultrasound (transesophageal ultrasound or intravascular ultrasound), and lumbar drainage of the cerebrospinal fluid were not included in this study. Specifically for each indication, the analyzed variables were as follows: the acute or chronic presentation form in dissections, ruptured or intact aneurysms, and the type of thoracic aortic trauma (type I, type II, type III, or type IV) as per the classification from Azizzadeh et al.7 In patients with DTAA, the diameter of the aorta was determined at the time of repair and its etiopathogenesis. In the complicated TBAD, the indication for intervention was taken into account, in addition to the maximum aortic diameter. Postoperative complications included the following: infection, hemorrhage requiring reintervention, paraplegia, cerebrovascular accident, acute coronary events, renal failure requiring dialysis, respiratory failure, and intestinal ischemia.2,6,8 We also analyzed survival at 30 days and in the 4-year follow-up period, as well as the percentage of endovascular reinterventions at 30 days. Statistical Analysis Continuous variables are expressed as mean ± standard deviation. The categorical data are given as a percentage. Perioperative survival, up to 4 years, has been estimated using the Kaplan-Meier analysis. The comparison of survival rates has been made by the log-rank test and the Gehan test. Mortality predictors were identified by Cox regression. Statistical analysis was performed using the IBM SPSS 24 program. The level of statistical significance has been reached for P < 0.05.
RESULTS Population From 2012 to 2016, 287 patients were consecutively included: 239 men (83.3%) and 48 women (16.7%) from 11 vascular surgery units in Spain. The
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Table I. Data collected in the Regis-TEVAR Preoperative data
Age Sex Cardiovascular risk factors
Diabetes Ischemic heart disease Chronic obstructive pulmonary disease Cerebrovascular disease
ASA grade Creatinine levels Disease specific data based on indication for TEVAR
Thoracic type B aortic dissection (TBAD)
Descending thoracic aortic aneurysm (DTAA) Traumatic thoracic aortic injuries (TAI) Others: hematoma intramural (IMH), penetrating aortic ulcer (PAU),.
Acute/chronic Indications for repair acute TEVARs
Visceral ischemia Rupture Dilatation Refractory pain Extremity ischemia
Intact/rupture Aortic pathology Maximum aortic diameter Trauma severity grading
Operative data
Proximal landing zone Distal landing zone Number of implanted stent grafts Type of stent grafts used Covered aortic branches Revascularization of branches
Figure 1 Figure 2
Left carotid, left subclavian, celiac trunk, superior mesenteric artery, left renal artery, right renal artery Left carotid, left subclavian, celiac trunk, superior mesenteric artery, left renal artery, right renal artery
Blood loss Postoperative data Hemorrhage requiring return to theater Infection Postoperative stroke within 30 days Paraplegia Acute coronary event Renal replacement therapy Ischemic bowel Respiratory failure 30-day mortality Survival after the operation Reintervention in the first 30 days
number of patients included per center oscillated between 8 and 78 cases. The average age was 64.1 ± 14.2 years. 17.1% of the patients were diabetic, with ischemic heart disease in 37.3% and chronic obstructive pulmonary disease in 26.8%. The main cardiovascular risk factors (Table II)
None, chest, wound, graft, others. Disabling, nondisabling
highlight a preoperative anesthetic risk scale of the American Society of Anesthesiologist IV and V in 43.3% (120) of the patients. The most frequent indications for TEVAR were DTAA, 155 cases (54%); followed by TBAD, 90 cases (31.4%); TAI, 36 cases (12.5%); and other less
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Table II. General characteristics of the patients General characteristics
Sex Age Risk factors Diabetes mellitus Ischemic heart disease COPDa Cerebrovascular disease Paraparesia preoperatoria ASA grade ASAb I ASA II ASA III ASA IV ASA V Fig. 1. Classification of aortic segments and possible proximal landing zones of thoracic aortic endoprosthesis.
n ¼ 287
Male 83.7% (239) Female 16.7% (48) 64.1 ± 14.2 (16e86) 17.1% (49) 37.3% (107) 26.8% (77) 8.7% (25) 2.8% (8) 2.1% (6) 10.1% (29) 44.6% (128) 22% (63) 21.3% (61)
Continuous data are presented as the mean ± standard deviation (rank), and the categorical data are given as the counts (percentages). a COPD: chronic obstructive pulmonary disease. b ASA: Anesthetic Risk Scale of the American Society of Anesthesiologist.
as mycotic, or connective tissue diseases. The aneurysm diameter was greater than 6 cm in 65.4% of the cases, being below 5 cm in 19.2% of the cases (Table IV). Of the 90 patients with TBAD, 63.3% of patients were operated in the first 2 weeks after the dissections occurred, compared with 34.4% of patients who were operated later. With regard to TAI, 88.9% of patients were operated urgently. Twenty-two (61%) of the thoracic injuries were type III or pseudoaneurysms and 11 (30.6%) were type IV (aortic ruptures). There were 8 cases of preoperative paraparesis: none in the dissection group, 4 in TAI, and 4 in the DTAA group (2.8% of preoperative paraparesis: 2.6% in the DTAA group and 11.1% in the TAI group). Fig. 2. Classification of aortic segments and possible distal landing zones of the thoracic aortic endoprosthesis.
Procedure Technique frequent cases such as intramural hematomas and penetrating ulcers (2.1%) (Table III). There were 8 cases of preoperative paraparesis (2.8%). In accordance with the type of admission, surgery was elective in 152 cases (53%), compared with 135 patients (47%) who underwent emergency surgery (before 24 hr); 72.3% of the aneurysm, 40% of the dissections and 11.1% of the traumatic aortic injuries were also operated electively. 40% of the dissections and 11.1% of the traumatic aortic injuries were also operated electively. Of the 155 patients with DTAA, 67.1% were arteriosclerotic, compared with other etiologies such
With regard to the number of implanted stent grafts, most patients were treated with 1 stent graft (50.2%), 37.5% with 2 stent grafts and 12.4% requiring 3 or more. Proximal landing zone (Fig. 1): The stent graft was delivered distal to the left subclavian artery (LSA) in 42.7% (46.7% of the DTAA, 35.6% of the TBAD, and 45.7% of the TAI). The LSA was intentionally covered (zone 2) in a total of 106 cases (36.9%): 18.7% in the DTAA, 50% in the TBAD, and 48.6% in the TAI. The LSA was covered without revascularization in 55 cases and with revascularization in 51 cases, which represents a 48% frequency
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Table III. Mode of admission and indication for endovascular repair of thoracic aorta Mode of admission n ¼ 287 Dissections n ¼ 90
Elective surgery
Emergency surgery
152 (53%) 36 40.0% 135 (47%) 54 60.0%
Aneurysm n ¼ 155
Aortic trauma n ¼ 36
112 72.3%
4 11.1%
43 27.7%
32 88.9%
Indication for TEVAR n ¼ 287
Descending thoracic aorta aneurysm (DTAA) Thoracic type B aortic dissection (TBAD) Traumatic thoracic aortic injuries (TAI) Others (IMHa, PAUa, etc.) a
155 90 36 6
54% 31.4% 12.5% 2.1%
IMH, intramural hematoma; PAU, penetrating aortic ulcer.
Table IV. Maximum aortic diameter of the 155 patients with descending thoracic aortic aneurysm (DTAA) treated by endoprosthesis in Regis-TEVAR Maximum aortic aneurysm diameter
Number of patients
%
<50 mm 50-60 mm 60 mm Unknown data Total
26 20 87 22 155
19.5% 15.0% 65.4% 14.2% 100%
of revascularization; there was no statistically significant differences in the rate of paraplegia or stroke between both the groups. In 35 patients (12% of the series), it was necessary to cover the left carotid artery (zone 1); all these cases were revascularized. There were only 2 cases of retrograde dissections at the time of implantation. Distal landing zone (Fig. 2): 52.1% were fixed in zone 5 and 35.1% in zone 4, which makes a total of 83.2% of landings above the celiac trunk (CT) without visceral branches coverage. 10.5% of the distal stent grafts were deployed in zones 6, 7, and 8, which involved the coverage of 8 CTs (75% revascularized), 4 superior mesenteric arteries (100% revascularized), and 9 renal arteries (100% revascularized). No specific data on the type of revascularization were obtained. Mortality and Reinterventions The overall mortality was 11.49% (33 of the 287 patients died during the first 30 days after the
operation): 13.3% in the TBAD, 12.3% in the DTAA, and 5.6% in the TAI. Mortality varies depending on the form of presentation; if the repair was urgent, the mortality increased to 18.5% (17.5% in the TBAD and 50% in the ruptured DTAA) and decreased in the elective cases to 5.3% (6.5% in the TBAD and 5.2% in DTAA). Survival by actuarial Kaplan-Meier method was calculated for a maximum follow-up of 60 months, although only 20% of the patients exceeded 48 months of follow-up; so actuarial survival was limited to 4 years. And 73 ± 4% arrived alive at the end of the follow-up period and 16% died during this period (Fig. 3). The actuarial survival for 48 months in accordance with the etiological cause was as follows: for aortic ulcers, 100%; for TAI, 86 ± 7%; for dissections, 82 ± 6%; and for aneurysm, 65 ± 5% (Fig. 4). Attempts have been made to identify predictors of mortality/survival using Cox regression. This analysis was made in 2 phases: first phase for preoperative variables (age, urgent/scheduled admission,
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Fig. 3. Kaplan-Meier curve of survival of the entire group that exceeded the first month after the surgery, along the first 48 months. At the bottom of the curve is
the absolute number of patients who survive each year, also the annual survival rate. The actuarial average survival is 57.276 months. CI (53.851e60.701).
risk factors, ASA grade, and type of disease for TEVAR) and none of these conditioned mortality; second phase for variables identified such as complications, as hemorrhage (P ¼ 0.037) having a hazard ratio of 2.92, with a 95% CI of 1.06e8.07 and postoperative respiratory failure (P ¼ 0.007) having obtained statistical significance with a hazard ratio of 2.57 and 95% CI of 1.3e5.1. The rest of the complications were not identified as significant. Reinterventions during admission were necessary in 23 patients (8.1%), more frequent in dissections (11.1%) than others pathologies.
forms), together with a frequency of postoperative paraplegia of 4.9% (the highest again in dissections 6.8%, 8.8% in the acute forms and 3.2% in the chronic forms). Coronary events occurred in 2.1% of the operated patients, and 7.3% required postoperative hemofiltration. Mesenteric ischemia occurred in 3.5% of cases, being more frequent among dissections (6.5%). In patients with thoracic aortic trauma, one-third of the cases suffered postoperative respiratory failure, being only 15% in the rest of the groups.
Immediate Postoperative Complications
DISCUSSION
The frequency of postoperative hemorrhages was 5.6%, being higher in thoracic aneurysms (8.4%; Table V). The infection of any location reached 6.6% (13.9% in TAI, mainly respiratory infection). There were 3.1% cases of postoperative stroke, mainly in the dissections (5.7% in the total of the TBAD, 7% in the acute, and 3.2% in the chronic
The pathology of the descending thoracic aorta encompasses a broad spectrum of degenerative, structural, genetic, and traumatic diseases. Its real incidence is uncertain but known that it is increasing because of the aging of the population and the improvement in diagnostic methods.9 The most common forms of presentation are DTAA, TBAD, TAI,
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Spanish multicenter TEVAR registry 7
Fig. 4. Kaplan-Meier survival curve of each of the subgroups of pathology in the first 48 months. Under the curve in the second column is the number of patients that form each subgroup. In the following columns is the annual survival rate. The actuarial average survival for the cases of dissection is 61.541 months, CI (56.135e66.974). For the aneurysm cases, it is
53.199 months, CI (48.171e58.227). Injuries have had an average survival of 52.983 months, CI (47.468e 58.497). For intramural hematomas and penetrating ulcers, it has not been estimated because they have all come alive at 48-month follow-up, and they are only 6 patients. Print color requested.
penetrating ulcers (PAU), and intramural hematomas that in our series coincide with 54%, 31, 4%, 12.5%, and 2.1% of cases, respectively. Since 1996, these lesions can be treated in 3 ways: open surgery (OR), endovascular procedures (TEVAR), or hybrid techniques that combine the 2 previous ones. The main advantage of endovascular procedures is their lower invasiveness and their potential reduction in morbidity and mortality compared with classical OR. For endovascular repair, there are 3 metaanalyses available in complicated TBADs, which show an in-hospital mortality between 2.6% and 9.8% and a postoperative stroke rate generally associated with the manipulation of the guides in the arch, between 3% and 10%.9e11 In our series, mortality was higher (17.5%) with rates of stroke and similar
postoperative paraplegia (5.7% and 6.8%). On the other hand, in-hospital mortality of classical surgical open repair (OR) remains high, between 25% and 50%. The recent European guideline on the management of descending thoracic aorta diseases considers open repair as an alternative to endovascular therapy after failure of endovascular management or where endovascular interventions are contraindicated.12 In another recent meta-analysis of TEVARs on chronic TBAD, mortality for OR has been shown to be higher than 20%,13,14 than 3.2% of the TEVARs (6.5% in our Regis-TEVAR). There are no randomized controlled trials comparing OR with endovascular treatment in cases of ruptured thoracic aneurysms. However, in a recent meta-analysis,15 30-day mortality was 33% and 19%, being
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Table V. Postoperative complications Postoperative complications Complications
Total
Dissections
Aneurysm
Trauma
Others
Hemorrhage Infection Stroke Paraplegia Acute coronary events Renal replacement therapy Respiratory failure Ischemic bowel Reinterventions 30-day mortality
5.6% 6.6% 3.1% 4.9% 2.1% 7.3% 15% 3.5% 8.1% 11.5%
2.2% 4.4% 5.7% 6.8% 2.2% 11.1% 14.4% 6.7% 11.1% 13.3%
8.4% 6.5% 1.9% 3.9% 2.6% 5.8% 11 % 2.6% 7.25 12.3%
2.8% 13.9% 0% 5.6% 0% 5.6% 33.3% 0% 5.6% 5.6%
0% 0% 0% 0% 0% 0% 16.7% 0% 0% 0%
Dissections
Aneurysms
Acute
Chronic
Intact
Ruptured
17.5%
6.5%
5.2%
50%
somewhat higher in our series. In the case of thoracic aortic injuries, endovascular treatment has become the first therapeutic option since its inception, demonstrating a reduction in mortality from 27.7% for OR to 9.7% for patients who underwent endovascular treatment (5.6 % in our series).16 In terms of long-term survival, a North American report with more than 11.166 patients undergoing thoracic aortic repair demonstrates that 5-year survival is equal for both techniques (TEVAR vs. OR), once the initial increase in mortality after OR has been overcome.17 In our series, survival is high and is influenced by factors such as hemorrhage and respiratory failure. The evident benefits of TEVAR must be balanced against the risks associated with the management of the guidewires in the aortic arch, the need to cover a large area of the thoracic aorta, or to occlude the LSA, which leads to an increased risk of stroke and postoperative paraplegia. Published postoperative stroke rates range between 3% and 10%, especially in patients with severe arteriosclerotic pathology of the aortic arch and high risk of embolization.18 In Regis-TEVAR, it remained close to 3.1%, being higher in the TBAD group (5.7%) and with coverage of the LSA (7.1%), but without reaching statistically significant differences. The LSA coverage is often necessary to achieve a good proximal landing during the TEVAR and reaches 38% of the cases in several series (36.9% in our registry).19 There is not enough scientific evidence available to indicate the mandatory revascularization of LSA in all cases; it is recommended in emergency situations, in patients with permeable coronary bypass from the left internal mammary artery
or with a single or dominant left vertebral artery. Another devastating complication is spinal cord ischemia that manifests as paraparesis or paraplegia with incidences ranging from 2% to 6% in the literature.20 In our registry, paraplegia reached 4.9%, within the limits expected based on the evidence. However, we have not recorded the medullar protection measures that have achieved these results. A protocolized patients’ follow-up is essential for both techniques, to avoid the development of anastomotic pseudoaneurysms in OR, migrations, infection, endoleaks, or stent graft fractures in the case of TEVARs.8,21e23 In a recent review by Fairman AS et al.,8 6.180 patients treated with TEVAR were evaluated and data were included in the US Vascular Quality Initiative registry from 2010. An in-hospital reintervention rate of 3.29% was reported. In our series, there was a percentage of reinterventions of 8.1% at 30 days, mainly in the dissection group (11.1%). The available evidence recommends that the deployment of these endovascular devices in the thoracic aorta has to be performed in accordance with precise anatomical and clinical requirements.12,24,25 There are no published randomized controlled trials comparing OR against TEVAR and most of the evidence is obtained from international registries. Regis-TEVAR shows the daily and real clinical activity in a multicentric, collaborative, and independent way of the industry. Evidently, it has two limitations: it is a retrospective study and does not include all the vascular units that treat this pathology, if not a sample of 11 of them. However, it is advantageous to reflect that our clinical
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practice adjusts to the international thoracic endovascular practice. The distribution of pathologies treated in our series is very similar to that published in other registers.24,26e29 Other specific features to be taken into account in TEVARs are as follows: 1) the number of stent grafts deployed, which in our series involves a single stent graft in 49.5% of the cases and 36.9% with 2 implants, and 2) the proximal and distal landing zones because the coverage or noncoverage of the LSA and the higher number of stent graft modules imply greater risk of stroke and paraplegia. In our registry, 43% of the proximal landing zones were landed distal to the LSA. On the other hand, in TBAD cases, it was more frequent to require a proximal landing, which implies the coverage of the LSA. The distal landing zone did not surpass zone 4, and in 88.2% of the cases, the CT was not reached. This decreased the risk of injury to the intestinal vascularization with low rates of mesenteric ischemia: 3.5% in our series (taking into account that 8 CTs were covered and 6 of them were revascularized). Jeffrey et al.30 presented an extensive review of the literature with intentional coverage of the CT and showed low rates of intestinal complications, provided that there is adequate collaterality with the superior mesenteric artery (SMA) and that it is healthy. If the stent graft covers the renal arteries, it could cause acute renal failure, within other causes as renal embolization and contrast media injury. In our series, only 7.3% of patients required long-term renal replacement therapy, especially in dissections (11.1%). In other series, the frequency ranges between 1% and 34%, the range being so wide because of discrepancies in the definition, the dose of contrast administered, and the preoperative renal dysfunction.31 There are several factors that reduce the validity of this work, such as its retrospective nature and the absence of a control group of patients with OR. However, the existence of detailed information with regard to the technique and its complications compensates for these weaknesses and makes it comparable to the results published by other series. Being a retrospective study, the follow-up is different in each patient. In some cases, it was completed up to 5 years and less time in others.
CONCLUSIONS For the first time, a Spanish registry of endovascular treatment of thoracic aortic pathology has been published, giving complete information of the real clinical practice and with results similar to international
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series of OR. In accordance with our data, TEVAR can be performed with acceptable morbidity and mortality and with low rates of postoperative complications. Our study confirms treatment advantages for TEVAR for thoracic aortic diseases. It is not likely that randomized trials will be performed; prospective population-based studies including thoracic descending aortic diseases will provide the best attainable level of evidence on this issue. National registries complement the scientific evidence in this pathology.
Thanks to the Chapter of Endovascular Surgery (CCEV) and the Spanish Society of Vascular Surgery (SEACV) for the support to this project to promote initiatives to improve the quality of care in their specialty. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
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from the International Registry of Acute Aortic Dissection (IRAD). Circulation 2006;114(Suppl 1):I357e64. Thrumurthy SG, Karthikesalingam A, Patterson BO, et al. A systematic review of mid-term outcomes of thoracic endovascular repair (TEVAR) of chronic type B aortic dissection. Eur J Vasc Endovasc Surg 2011;42:632e47. Jonker FH, Trimarchi S, Verhagen HJ, et al. Meta-analysis of open versus endovascular repair for ruptured descending thoracic aortic aneurysm. J Vasc Surg 2010;51:1026e30. Karmy-Jones R, Ferrigno L, Teso D, et al. Endovascular repair compared with operative repair of traumatic rupture of the thoracic aorta: a nonsystematic review and a plea for traumaspecific reporting guidelines. J Trauma 2011;71:1059e72. Conrad MF, Ergul EA, Patel VI, et al. Management of diseases of the descending thoracic aorta in the endovascular era: a Medicare population study. Ann Surg 2010;252:603e10. Buth J, Harris PL, Hobo R. Neuropathy associated with endovascular repair of thoracic aortic pathology: incidence and risk factors. a study from the European Collaborators on Stent/Graft Technologies for Aortic Aneurysm Repair (EUROSTAR) registry. J Vasc Surg 2007;46:1103e10. Matsumura JS, Lee WA, Mitchell RS, et al. The Society for Vascular Surgery Practice Guidelines: management of the left subclavian artery with thoracic endovascular aortic repair. J Vasc Surg 2009;50:1155e8. Coselli JS, LeMaire SA, Koksoy C, et al. Cerebrospinal fluid drainage reduces paraplegia after throracoabdominal aortic aneurysm repair: results of a randomized clinical trial. J Vasc Surg 2002;35:631e9. Tsai TT, Trimarchi S, Nienaber CA. Acute aortic dissection: perspectives from the international registry of acute aortic dissection (IRAD). Eur J Vasc Endovasc Surg 2009;37:149e59. Tsai TT, Fattori R, Trimarchi S, et al. Long-term survival in patients presenting with type B acute aortic dissection: insights from the International Registry of Acute Aortic Dissection. Circulation 2006;114:2226e31.
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23. Desai ND, Burtch K, Moser W, et al. Long-term comparison of thoracic endovascular aortic repair (TEVAR) to OR for the treatment of thoracic aortic aneurysms. J Thorac Cardiovasc Surg 2012;144:604e9. 24. Grabenw€ oger M, Alfonso F, Bachet J, et al. Thoracic endovascular aortic repair (TEVAR) for the treatment of aortic diseases: a position statement from the European association for cardio-thoracic surgery (EACTS) and the European society of cardiology (ESC) in collaboration with the European association of percutaneous cardiovascular inteventions (EAPCI). Eur J Cardiothorac Surg 2012;42:17e24. 25. Boodhwani M, Andelfinger G, Leipsic J, et al. Canadian Caridovascular Society position statement on the management of thoracic aortic Disease. Can J Cardiol 2014;30:577e89. 26. Heijmen R, Fattori R, Thompson M, et al. Virtue Registry Investigators. The VIRTUE Registry of type B thoracic dissections and study design and early results. Eur J Vasc Endovasc Surg 2011;41:159e66. 27. Gopaldas RR, Dao TK, LeMaire SA, et al. Endovascular versus open repair of ruptured descending thoracic aortic aneurysms: a nationwide risk-adjusted study of 923 patients. J Thorac Cardiovasc Surg 2011;142:1010e8. 28. Ricco JB, Cau J, Marchand C, et al. Stent-graft repair for thoracic aortic Disease: results of an independent nationwide study in France from 1999 to 2001. J Thorac Cardiovasc Surg 2006;131:131e7. 29. Zahn R, Erbel R, Nienaber CA, et al. Endovascular aortic repair of thoracic aortic Disease: early and 1-year results from a German multicenter registry. J Endovasc Ther 2013;20:265e72. 30. Jeffrey Jim, Caputo FJ, Sanchez LA. Intentional coverage of the celiac artery during thoracic endovascular aortic repair. J Vasc Surg 2013;58:270e5. 31. Drews JD, Patel HJ, Williams DM, et al. The impact of acute renal failure on early and late outcomes after thoracic aortic endovascular repair. Ann Thorac Surg 2014;97:2027e33.
Background: Endovascular techniques have become an essential tool for treatment of thoracic aortic pathology. The objective of this study was to analyze indications and results of thoracic endovascular aortic repair (TEVAR) in vascular surgery units, through a retrospective and multicentric national registry called Regis-TEVAR. Methods: From 2012 to 2016, a total of 287 patients from 11 vascular surgery units, treated urgently and electively, were recruited consecutively. The primary variables analyzed are mortality, survival, and reintervention rate. The following indications for TEVAR were also analyzed: aortic dissections, thoracic aneurysms, traumatisms, and intramural hematomas or penetrating ulcers, as well as results and postoperative complications in accordance with each indication. Results: Of the 287 TEVAR performed (239 men, mean age 64.1 ± 14.1 years), 155 were because of aortic aneurysm (54%), 90 because of type B aortic dissection (31.4%), 36 because of traumatic aortic rupture (12.5%), and 6 because of penetrating ulcers or intramural hematomas (2.1%). Overall mortality at 30 days was 11.5% (18.5% in urgent and 5.3% in elective), being higher in dissections (13.3%). The median actuarial survival was 73% at 4 years. The stroke rate was 3.1%, and the rate of spinal cord ischemia was 4.9%. Aortic reoperations were necessary in 23 patients (8.1%). Conclusions: This registry provides complete and reliable information on real clinical practice of TEVAR in Spain, with results similar to international series of open surgery. In accordance with these data, TEVAR can be performed with acceptable morbidity and mortality and with low rates of postoperative complications.
1 Vascular Surgery Unit, University Hospital Virgen de las Nieves of Granada, Spain. 2
Vascular Surgery Unit, University Hospital Vall d’Hebron of Barcelona, Spain. 3 Vascular Surgery Unit, University Hospital Bellvitge of Barcelona, Spain. 4
Vascular Surgery Unit, University Hospital Son Espases Palma de Mallorca, Spain. 5 Vascular Surgery Unit, Corporacio Sanitaria Parc Tauli de Sabadell, Spain. 6
Vascular Surgery Unit, University Hospital Dr.Negrı´n de Gran Canaria, Spain. 7
Vascular Surgery Unit, University Hospital Guadalajara, Spain.
8
Vascular Surgery Unit, University Hospital Cabue~ nes, Spain.
9
Vascular Surgery Unit, Hospital de Galdakao, Spain.
10
Vascular Surgery Unit, University Hospital Basurto, Spain. Vascular Surgery Unit, University Hospital La Fe Valencia, Spain.
11
Correspondence to: Cristina Lopez Espada, Coordinator of the RegisTEVAR Collaborative Group, Vascular Surgery Unit University Hospital Virgen de las Nieves, Avenue De las Fuerzas Armadas, 2, 18014 Granada, Spain; E-mail: [email protected] Ann Vasc Surg 2020; -: 1–10 https://doi.org/10.1016/j.avsg.2020.02.012 Ó 2020 Elsevier Inc. All rights reserved. Manuscript received: October 24, 2019; manuscript accepted: February 6, 2020; published online: - - -
1
2 Lopez Espada et al.
INTRODUCTION The techniques for thoracic endovascular aortic repair (TEVAR) have revolutionized in recent years the treatment of patients with different pathologies: type B dissections (TBAD), descending thoracic aortic aneurysms (DTAA), traumatic thoracic aortic injuries (TAI), intramural hematomas (IMH), penetrating aortic ulcers (PAU), and so on. TEVAR consists in implanting a stent graft by means of femoral access, with the aim of excluding such lesions. A priori, these are less invasive techniques than conventional open surgery, which leads to lower morbidity and mortality.1 Globally accumulated evidence shows that TEVAR can reduce mortality, paraplegia, and the overall rate of complications, compared with open surgery (OR),2e4 which it has made the procedure of choice in high-risk patients and in a critical situation. In Spain, it was deployed for the first time in 1995,5 and since then, the expansion has been spectacular, requiring a review of its indications, complications, and limitations of a technique that has been adopted by multiple specialties including cardiologists, cardiac surgeons, radiologists, and vascular surgeons. The aim of this observational study was to analyze the indications and the results of TEVAR, through the data obtained from a national multicenter registry. This is the first publication of a Spanish registry of patients treated by TEVAR.
MATERIALS AND METHODS Study Design The Regis-TEVAR study is a retrospective and multicentric national registry in angiology and vascular surgery units in Spain. It comprised 5 years of inclusion from January 2012 to December 2016. The Spanish Endovascular Chapter and the Spanish Society of Vascular Surgery sponsored the creation of a voluntary database, where the clinical units could provide information about their practice in the TEVAR. They were invited to participate through the forums of scientific diffusion of our scientific society and 11 clinical units accepted. The registry was carried out independently of the industry and supported by the interest of the vascular society. In 2017, the database used was validated by the Vascunet, a European working group for the collaboration of international vascular registries, administered and funded by the European Society of Vascular Surgery. This working group was established to improve the quality, safety, and efficiency of vascular care in Europe and Australia.
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The data have been collected by physicians in charge of the patient, together with the approval from the ethics institutional review board, to participate in this registry and obtained locally in each institution. The database includes 4 sections: preoperative demographic data with 9 variables, specific data as per the clinical indication with 13 variables, intraoperative data with 17 variables, and postoperative data with 16 variables (see Table I). The proximal and distal landing zones were based on the classification by Fillinger et al.6 (see Figs. 1 and 2). Data such as femoral access type (percutaneous vs. open), use of ultrasound (transesophageal ultrasound or intravascular ultrasound), and lumbar drainage of the cerebrospinal fluid were not included in this study. Specifically for each indication, the analyzed variables were as follows: the acute or chronic presentation form in dissections, ruptured or intact aneurysms, and the type of thoracic aortic trauma (type I, type II, type III, or type IV) as per the classification from Azizzadeh et al.7 In patients with DTAA, the diameter of the aorta was determined at the time of repair and its etiopathogenesis. In the complicated TBAD, the indication for intervention was taken into account, in addition to the maximum aortic diameter. Postoperative complications included the following: infection, hemorrhage requiring reintervention, paraplegia, cerebrovascular accident, acute coronary events, renal failure requiring dialysis, respiratory failure, and intestinal ischemia.2,6,8 We also analyzed survival at 30 days and in the 4-year follow-up period, as well as the percentage of endovascular reinterventions at 30 days. Statistical Analysis Continuous variables are expressed as mean ± standard deviation. The categorical data are given as a percentage. Perioperative survival, up to 4 years, has been estimated using the Kaplan-Meier analysis. The comparison of survival rates has been made by the log-rank test and the Gehan test. Mortality predictors were identified by Cox regression. Statistical analysis was performed using the IBM SPSS 24 program. The level of statistical significance has been reached for P < 0.05.
RESULTS Population From 2012 to 2016, 287 patients were consecutively included: 239 men (83.3%) and 48 women (16.7%) from 11 vascular surgery units in Spain. The
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Table I. Data collected in the Regis-TEVAR Preoperative data
Age Sex Cardiovascular risk factors
Diabetes Ischemic heart disease Chronic obstructive pulmonary disease Cerebrovascular disease
ASA grade Creatinine levels Disease specific data based on indication for TEVAR
Thoracic type B aortic dissection (TBAD)
Descending thoracic aortic aneurysm (DTAA) Traumatic thoracic aortic injuries (TAI) Others: hematoma intramural (IMH), penetrating aortic ulcer (PAU),.
Acute/chronic Indications for repair acute TEVARs
Visceral ischemia Rupture Dilatation Refractory pain Extremity ischemia
Intact/rupture Aortic pathology Maximum aortic diameter Trauma severity grading
Operative data
Proximal landing zone Distal landing zone Number of implanted stent grafts Type of stent grafts used Covered aortic branches Revascularization of branches
Figure 1 Figure 2
Left carotid, left subclavian, celiac trunk, superior mesenteric artery, left renal artery, right renal artery Left carotid, left subclavian, celiac trunk, superior mesenteric artery, left renal artery, right renal artery
Blood loss Postoperative data Hemorrhage requiring return to theater Infection Postoperative stroke within 30 days Paraplegia Acute coronary event Renal replacement therapy Ischemic bowel Respiratory failure 30-day mortality Survival after the operation Reintervention in the first 30 days
number of patients included per center oscillated between 8 and 78 cases. The average age was 64.1 ± 14.2 years. 17.1% of the patients were diabetic, with ischemic heart disease in 37.3% and chronic obstructive pulmonary disease in 26.8%. The main cardiovascular risk factors (Table II)
None, chest, wound, graft, others. Disabling, nondisabling
highlight a preoperative anesthetic risk scale of the American Society of Anesthesiologist IV and V in 43.3% (120) of the patients. The most frequent indications for TEVAR were DTAA, 155 cases (54%); followed by TBAD, 90 cases (31.4%); TAI, 36 cases (12.5%); and other less
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Table II. General characteristics of the patients General characteristics
Sex Age Risk factors Diabetes mellitus Ischemic heart disease COPDa Cerebrovascular disease Paraparesia preoperatoria ASA grade ASAb I ASA II ASA III ASA IV ASA V Fig. 1. Classification of aortic segments and possible proximal landing zones of thoracic aortic endoprosthesis.
n ¼ 287
Male 83.7% (239) Female 16.7% (48) 64.1 ± 14.2 (16e86) 17.1% (49) 37.3% (107) 26.8% (77) 8.7% (25) 2.8% (8) 2.1% (6) 10.1% (29) 44.6% (128) 22% (63) 21.3% (61)
Continuous data are presented as the mean ± standard deviation (rank), and the categorical data are given as the counts (percentages). a COPD: chronic obstructive pulmonary disease. b ASA: Anesthetic Risk Scale of the American Society of Anesthesiologist.
as mycotic, or connective tissue diseases. The aneurysm diameter was greater than 6 cm in 65.4% of the cases, being below 5 cm in 19.2% of the cases (Table IV). Of the 90 patients with TBAD, 63.3% of patients were operated in the first 2 weeks after the dissections occurred, compared with 34.4% of patients who were operated later. With regard to TAI, 88.9% of patients were operated urgently. Twenty-two (61%) of the thoracic injuries were type III or pseudoaneurysms and 11 (30.6%) were type IV (aortic ruptures). There were 8 cases of preoperative paraparesis: none in the dissection group, 4 in TAI, and 4 in the DTAA group (2.8% of preoperative paraparesis: 2.6% in the DTAA group and 11.1% in the TAI group). Fig. 2. Classification of aortic segments and possible distal landing zones of the thoracic aortic endoprosthesis.
Procedure Technique frequent cases such as intramural hematomas and penetrating ulcers (2.1%) (Table III). There were 8 cases of preoperative paraparesis (2.8%). In accordance with the type of admission, surgery was elective in 152 cases (53%), compared with 135 patients (47%) who underwent emergency surgery (before 24 hr); 72.3% of the aneurysm, 40% of the dissections and 11.1% of the traumatic aortic injuries were also operated electively. 40% of the dissections and 11.1% of the traumatic aortic injuries were also operated electively. Of the 155 patients with DTAA, 67.1% were arteriosclerotic, compared with other etiologies such
With regard to the number of implanted stent grafts, most patients were treated with 1 stent graft (50.2%), 37.5% with 2 stent grafts and 12.4% requiring 3 or more. Proximal landing zone (Fig. 1): The stent graft was delivered distal to the left subclavian artery (LSA) in 42.7% (46.7% of the DTAA, 35.6% of the TBAD, and 45.7% of the TAI). The LSA was intentionally covered (zone 2) in a total of 106 cases (36.9%): 18.7% in the DTAA, 50% in the TBAD, and 48.6% in the TAI. The LSA was covered without revascularization in 55 cases and with revascularization in 51 cases, which represents a 48% frequency
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Table III. Mode of admission and indication for endovascular repair of thoracic aorta Mode of admission n ¼ 287 Dissections n ¼ 90
Elective surgery
Emergency surgery
152 (53%) 36 40.0% 135 (47%) 54 60.0%
Aneurysm n ¼ 155
Aortic trauma n ¼ 36
112 72.3%
4 11.1%
43 27.7%
32 88.9%
Indication for TEVAR n ¼ 287
Descending thoracic aorta aneurysm (DTAA) Thoracic type B aortic dissection (TBAD) Traumatic thoracic aortic injuries (TAI) Others (IMHa, PAUa, etc.) a
155 90 36 6
54% 31.4% 12.5% 2.1%
IMH, intramural hematoma; PAU, penetrating aortic ulcer.
Table IV. Maximum aortic diameter of the 155 patients with descending thoracic aortic aneurysm (DTAA) treated by endoprosthesis in Regis-TEVAR Maximum aortic aneurysm diameter
Number of patients
%
<50 mm 50-60 mm 60 mm Unknown data Total
26 20 87 22 155
19.5% 15.0% 65.4% 14.2% 100%
of revascularization; there was no statistically significant differences in the rate of paraplegia or stroke between both the groups. In 35 patients (12% of the series), it was necessary to cover the left carotid artery (zone 1); all these cases were revascularized. There were only 2 cases of retrograde dissections at the time of implantation. Distal landing zone (Fig. 2): 52.1% were fixed in zone 5 and 35.1% in zone 4, which makes a total of 83.2% of landings above the celiac trunk (CT) without visceral branches coverage. 10.5% of the distal stent grafts were deployed in zones 6, 7, and 8, which involved the coverage of 8 CTs (75% revascularized), 4 superior mesenteric arteries (100% revascularized), and 9 renal arteries (100% revascularized). No specific data on the type of revascularization were obtained. Mortality and Reinterventions The overall mortality was 11.49% (33 of the 287 patients died during the first 30 days after the
operation): 13.3% in the TBAD, 12.3% in the DTAA, and 5.6% in the TAI. Mortality varies depending on the form of presentation; if the repair was urgent, the mortality increased to 18.5% (17.5% in the TBAD and 50% in the ruptured DTAA) and decreased in the elective cases to 5.3% (6.5% in the TBAD and 5.2% in DTAA). Survival by actuarial Kaplan-Meier method was calculated for a maximum follow-up of 60 months, although only 20% of the patients exceeded 48 months of follow-up; so actuarial survival was limited to 4 years. And 73 ± 4% arrived alive at the end of the follow-up period and 16% died during this period (Fig. 3). The actuarial survival for 48 months in accordance with the etiological cause was as follows: for aortic ulcers, 100%; for TAI, 86 ± 7%; for dissections, 82 ± 6%; and for aneurysm, 65 ± 5% (Fig. 4). Attempts have been made to identify predictors of mortality/survival using Cox regression. This analysis was made in 2 phases: first phase for preoperative variables (age, urgent/scheduled admission,
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Fig. 3. Kaplan-Meier curve of survival of the entire group that exceeded the first month after the surgery, along the first 48 months. At the bottom of the curve is
the absolute number of patients who survive each year, also the annual survival rate. The actuarial average survival is 57.276 months. CI (53.851e60.701).
risk factors, ASA grade, and type of disease for TEVAR) and none of these conditioned mortality; second phase for variables identified such as complications, as hemorrhage (P ¼ 0.037) having a hazard ratio of 2.92, with a 95% CI of 1.06e8.07 and postoperative respiratory failure (P ¼ 0.007) having obtained statistical significance with a hazard ratio of 2.57 and 95% CI of 1.3e5.1. The rest of the complications were not identified as significant. Reinterventions during admission were necessary in 23 patients (8.1%), more frequent in dissections (11.1%) than others pathologies.
forms), together with a frequency of postoperative paraplegia of 4.9% (the highest again in dissections 6.8%, 8.8% in the acute forms and 3.2% in the chronic forms). Coronary events occurred in 2.1% of the operated patients, and 7.3% required postoperative hemofiltration. Mesenteric ischemia occurred in 3.5% of cases, being more frequent among dissections (6.5%). In patients with thoracic aortic trauma, one-third of the cases suffered postoperative respiratory failure, being only 15% in the rest of the groups.
Immediate Postoperative Complications
DISCUSSION
The frequency of postoperative hemorrhages was 5.6%, being higher in thoracic aneurysms (8.4%; Table V). The infection of any location reached 6.6% (13.9% in TAI, mainly respiratory infection). There were 3.1% cases of postoperative stroke, mainly in the dissections (5.7% in the total of the TBAD, 7% in the acute, and 3.2% in the chronic
The pathology of the descending thoracic aorta encompasses a broad spectrum of degenerative, structural, genetic, and traumatic diseases. Its real incidence is uncertain but known that it is increasing because of the aging of the population and the improvement in diagnostic methods.9 The most common forms of presentation are DTAA, TBAD, TAI,
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Fig. 4. Kaplan-Meier survival curve of each of the subgroups of pathology in the first 48 months. Under the curve in the second column is the number of patients that form each subgroup. In the following columns is the annual survival rate. The actuarial average survival for the cases of dissection is 61.541 months, CI (56.135e66.974). For the aneurysm cases, it is
53.199 months, CI (48.171e58.227). Injuries have had an average survival of 52.983 months, CI (47.468e 58.497). For intramural hematomas and penetrating ulcers, it has not been estimated because they have all come alive at 48-month follow-up, and they are only 6 patients. Print color requested.
penetrating ulcers (PAU), and intramural hematomas that in our series coincide with 54%, 31, 4%, 12.5%, and 2.1% of cases, respectively. Since 1996, these lesions can be treated in 3 ways: open surgery (OR), endovascular procedures (TEVAR), or hybrid techniques that combine the 2 previous ones. The main advantage of endovascular procedures is their lower invasiveness and their potential reduction in morbidity and mortality compared with classical OR. For endovascular repair, there are 3 metaanalyses available in complicated TBADs, which show an in-hospital mortality between 2.6% and 9.8% and a postoperative stroke rate generally associated with the manipulation of the guides in the arch, between 3% and 10%.9e11 In our series, mortality was higher (17.5%) with rates of stroke and similar
postoperative paraplegia (5.7% and 6.8%). On the other hand, in-hospital mortality of classical surgical open repair (OR) remains high, between 25% and 50%. The recent European guideline on the management of descending thoracic aorta diseases considers open repair as an alternative to endovascular therapy after failure of endovascular management or where endovascular interventions are contraindicated.12 In another recent meta-analysis of TEVARs on chronic TBAD, mortality for OR has been shown to be higher than 20%,13,14 than 3.2% of the TEVARs (6.5% in our Regis-TEVAR). There are no randomized controlled trials comparing OR with endovascular treatment in cases of ruptured thoracic aneurysms. However, in a recent meta-analysis,15 30-day mortality was 33% and 19%, being
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Table V. Postoperative complications Postoperative complications Complications
Total
Dissections
Aneurysm
Trauma
Others
Hemorrhage Infection Stroke Paraplegia Acute coronary events Renal replacement therapy Respiratory failure Ischemic bowel Reinterventions 30-day mortality
5.6% 6.6% 3.1% 4.9% 2.1% 7.3% 15% 3.5% 8.1% 11.5%
2.2% 4.4% 5.7% 6.8% 2.2% 11.1% 14.4% 6.7% 11.1% 13.3%
8.4% 6.5% 1.9% 3.9% 2.6% 5.8% 11 % 2.6% 7.25 12.3%
2.8% 13.9% 0% 5.6% 0% 5.6% 33.3% 0% 5.6% 5.6%
0% 0% 0% 0% 0% 0% 16.7% 0% 0% 0%
Dissections
Aneurysms
Acute
Chronic
Intact
Ruptured
17.5%
6.5%
5.2%
50%
somewhat higher in our series. In the case of thoracic aortic injuries, endovascular treatment has become the first therapeutic option since its inception, demonstrating a reduction in mortality from 27.7% for OR to 9.7% for patients who underwent endovascular treatment (5.6 % in our series).16 In terms of long-term survival, a North American report with more than 11.166 patients undergoing thoracic aortic repair demonstrates that 5-year survival is equal for both techniques (TEVAR vs. OR), once the initial increase in mortality after OR has been overcome.17 In our series, survival is high and is influenced by factors such as hemorrhage and respiratory failure. The evident benefits of TEVAR must be balanced against the risks associated with the management of the guidewires in the aortic arch, the need to cover a large area of the thoracic aorta, or to occlude the LSA, which leads to an increased risk of stroke and postoperative paraplegia. Published postoperative stroke rates range between 3% and 10%, especially in patients with severe arteriosclerotic pathology of the aortic arch and high risk of embolization.18 In Regis-TEVAR, it remained close to 3.1%, being higher in the TBAD group (5.7%) and with coverage of the LSA (7.1%), but without reaching statistically significant differences. The LSA coverage is often necessary to achieve a good proximal landing during the TEVAR and reaches 38% of the cases in several series (36.9% in our registry).19 There is not enough scientific evidence available to indicate the mandatory revascularization of LSA in all cases; it is recommended in emergency situations, in patients with permeable coronary bypass from the left internal mammary artery
or with a single or dominant left vertebral artery. Another devastating complication is spinal cord ischemia that manifests as paraparesis or paraplegia with incidences ranging from 2% to 6% in the literature.20 In our registry, paraplegia reached 4.9%, within the limits expected based on the evidence. However, we have not recorded the medullar protection measures that have achieved these results. A protocolized patients’ follow-up is essential for both techniques, to avoid the development of anastomotic pseudoaneurysms in OR, migrations, infection, endoleaks, or stent graft fractures in the case of TEVARs.8,21e23 In a recent review by Fairman AS et al.,8 6.180 patients treated with TEVAR were evaluated and data were included in the US Vascular Quality Initiative registry from 2010. An in-hospital reintervention rate of 3.29% was reported. In our series, there was a percentage of reinterventions of 8.1% at 30 days, mainly in the dissection group (11.1%). The available evidence recommends that the deployment of these endovascular devices in the thoracic aorta has to be performed in accordance with precise anatomical and clinical requirements.12,24,25 There are no published randomized controlled trials comparing OR against TEVAR and most of the evidence is obtained from international registries. Regis-TEVAR shows the daily and real clinical activity in a multicentric, collaborative, and independent way of the industry. Evidently, it has two limitations: it is a retrospective study and does not include all the vascular units that treat this pathology, if not a sample of 11 of them. However, it is advantageous to reflect that our clinical
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practice adjusts to the international thoracic endovascular practice. The distribution of pathologies treated in our series is very similar to that published in other registers.24,26e29 Other specific features to be taken into account in TEVARs are as follows: 1) the number of stent grafts deployed, which in our series involves a single stent graft in 49.5% of the cases and 36.9% with 2 implants, and 2) the proximal and distal landing zones because the coverage or noncoverage of the LSA and the higher number of stent graft modules imply greater risk of stroke and paraplegia. In our registry, 43% of the proximal landing zones were landed distal to the LSA. On the other hand, in TBAD cases, it was more frequent to require a proximal landing, which implies the coverage of the LSA. The distal landing zone did not surpass zone 4, and in 88.2% of the cases, the CT was not reached. This decreased the risk of injury to the intestinal vascularization with low rates of mesenteric ischemia: 3.5% in our series (taking into account that 8 CTs were covered and 6 of them were revascularized). Jeffrey et al.30 presented an extensive review of the literature with intentional coverage of the CT and showed low rates of intestinal complications, provided that there is adequate collaterality with the superior mesenteric artery (SMA) and that it is healthy. If the stent graft covers the renal arteries, it could cause acute renal failure, within other causes as renal embolization and contrast media injury. In our series, only 7.3% of patients required long-term renal replacement therapy, especially in dissections (11.1%). In other series, the frequency ranges between 1% and 34%, the range being so wide because of discrepancies in the definition, the dose of contrast administered, and the preoperative renal dysfunction.31 There are several factors that reduce the validity of this work, such as its retrospective nature and the absence of a control group of patients with OR. However, the existence of detailed information with regard to the technique and its complications compensates for these weaknesses and makes it comparable to the results published by other series. Being a retrospective study, the follow-up is different in each patient. In some cases, it was completed up to 5 years and less time in others.
CONCLUSIONS For the first time, a Spanish registry of endovascular treatment of thoracic aortic pathology has been published, giving complete information of the real clinical practice and with results similar to international
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series of OR. In accordance with our data, TEVAR can be performed with acceptable morbidity and mortality and with low rates of postoperative complications. Our study confirms treatment advantages for TEVAR for thoracic aortic diseases. It is not likely that randomized trials will be performed; prospective population-based studies including thoracic descending aortic diseases will provide the best attainable level of evidence on this issue. National registries complement the scientific evidence in this pathology.
Thanks to the Chapter of Endovascular Surgery (CCEV) and the Spanish Society of Vascular Surgery (SEACV) for the support to this project to promote initiatives to improve the quality of care in their specialty. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
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