Endovascular repair in patients with aortic dissection and aortic aneurysm: A retrospective cohort study.

doi:10.21203/rs.3.rs-3773822/v1

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Endovascular repair in patients with aortic dissection and aortic aneurysm: A retrospective cohort study.

https://doi.org/10.21203/rs.3.rs-3773822/v1

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Background

Therapeutic options in patients with aortic diseases include medical treatment, surgical and percutaneous intervention. The latter has been proved to be safe in patients with aortic aneurysm (AA) and aortic dissection (AD), but still represents challenging and with significant mortality rates. For these reasons, we aimed to compare procedural and in-hospital complications in patients with AA and AD treated with transfemoral transcatheter endovascular aortic repair (EVAR).

Methods

Patients treated using transfemoral EVAR from 2012 to 2017 at the Hospital de Cardiología, Centro Médico Nacional Siglo XXI, Mexico City with complete computed tomography (CT) and diagnostic of AA and AD were included. Procedural and in-hospital related complications were compared among patients treated due to AA and AD. Endpoints of the study were in-hospital and thirty days all-cause mortality and any cause of readmission.

Results

A total of 38 patients with high quality CT were included in the analysis. From them, 25 had AA and 13 AD. Mean age was 64 ± 14 yeas, 23.7% were females. Urgent treatment was required in 31.6%, the number of prosthesis used was 2.13 [1, 5] per patients. No in-hospital mortality was observed. Type 1a endoleak was similar in both groups (AA 8% vs. AD 15.4%, p = 0.59). Conversion to surgery was needed only in one patient (AA 4% vs AD 0%, p > 0.99). No difference was observed regarding endovascular reintervention (16% vs. 15.4%, p > 0.99), graft thrombosis (12% vs. 0%, p = 0.53), spinal cord injury (0% vs. 15.4%, p = 0.11) or vascular complication (8% vs. 15.4%, p = 0.59%) between AA and AD respectively. No 30-days mortality was observed.

Conclusions

EVAR represents a safe procedure in patients presenting with AA or AD, with no in-hospital or 30 days mortality rate and very low reintervention rate.

Aortic aneurysm

Aortic dissection

Endovascular aortic repair

Aortic disease, including aortic aneurysm (AA), aortic dissection (AD), intramural haematoma (IMH), penetrating aortic ulcer (PAU) and traumatic aortic injury, represents a mortality rate from 2.49–2.78%, affecting mostly men over 60 years and those with typical cardiovascular risk factors (age, male sex, smoking, vascular disease, atherosclerosis, hypercholesterolemia and hypertension)(1–4).

Therapeutic management include medical therapy and surgical or endovascular treatment. While medical therapy is aimed to reduce and control risk of complications associated factors like blood pressure and heart rate(1), surgical or endovascular treatment is focused on aortic repair, and thus, reducing mortality associated to rupture. In type A AD or complex AA, surgical repair is the preferred option(5), while endovascular aortic repair (EVAR) is preferred for type B AD and non-complex AA(6–8), due to the nature of less invasive strategy.

EVAR has been proved to be safe(5, 9) and it has been the treatment option compared to surgical approach in aortic disease involving the descending aorta(1, 10). Even compared to inoperable patients, endovascular treatment has proved better survival and aneurysm-related survival up to 12 years of follow-up(11). The aim of this study is to compare procedural and in-hospital complications in patients with AA and AD treated with transfemoral transcatheter EVAR.

Study Population

This observational retrospective cohort analysis included patients undergoing transfemoral transcatheter EVAR at the Hospital de Cardiología, Centro Médico Nacional Siglo XXI, Mexico City, Mexico. All patients with AA or AD from the thoracic descendent or abdominal aorta treated using a transcatheter transfemoral EVAR were eligible for inclusion. After interdisciplinary discussion by the local heart team, patients were treated through transfemoral approach using percutaneous vascular system. For procedure planning, patients underwent 3D multi-slice computed tomography (MSCT). Anatomical characteristics were evaluated using 40-row multidetector CT scanner (Somatom Sensation 40, Siemens Medical Solutions, Forcheim, Germany). CT were evaluated by an experience interventional cardiologist in the field. Anatomical description of the aorto-iliac vessels including the location of the aortic lesion (AD or AA), its exact anatomy and morphology, involvement of other structures or vessels, the extent of the aneurysm sac, the relationships of the aneurysm neck and aortic injury site with adjacent aortic branch vessels, was done. Decision of treatment and endoprosthesis to be implanted was at discretion of the operator based on standard clinical guidelines(1). All patients provide written informed consent for the procedure and subsequent follow-up, either in-hospital or telephonic follow-up up to 30 days. The study was approved by local ethics committee from the Hospital de Cardiología, Centro Médico Nacional Siglo XXI under the number R-2017-3604-78 and complied with the Declaration of Helsinki.

Endpoints

Baseline clinical characteristics, procedural characteristics and in-hospital complications were obtained from hospital clinical records. In-hospital complications were compared among patients treated due to aortic dissection and aortic aneurysm, and included clinical related (pneumonia, acute renal failure, acute peripheral artery disease associated to access site, anemia, cardiac arrest) and procedural related (endoleak, bleeding, conversion to surgery, endovascular re-intervention, graft thrombosis, abdominal surgery, spinal-cord injury and vascular injury).

Endpoints of the study were in-hospital and thirty days all-cause mortality and any cause of readmission. Follow-up was established by telephone contact, hospital visit or follow-up letter.

Statistical analysis

Categorical variables were summarized using frequencies and proportions. Continuous data were tested for normality with the Shapiro-Wilk test, summarized using mean (± standard deviation) or median (inter- quartile range [IQR]) as appropriate. In-hospital complications and 30-days follow-up were compared using chi-square test or Fisher’s exact test, as appropriate

Statistical analysis was performed using IBM SPSS Statistics (Version 25, IBM^© Corporation). All tests were 2-sided at the 0.05 significance level.

A total of 38 patients treated with endovascular prosthesis due to AA or AD from the thoracic descendent or abdominal aorta with complete CT scan from 2012 to 2017 were identified in our institution (Hospital de Cardiología, Centro Médico Nacional Siglo XXI) (Fig. 1). Baseline characteristics are described in Table 1. The mean age of the entire population was 64 ± 14 years, 23.7% female, 71.1% with hypertension, mean left ventricular ejection fraction (LVEF) 60 ± 11%. AA was presented in 65.8% and AD in 34.2%.

Table 1

Baseline characteristics
	n = 38
Age, years, mean ± SD	64 ± 14
Male, %	29 (76.3)
BMI (kg/m²), mean ± SD 19–25, % 26–29, % 30–35, % 36–40, % >40, %	27.7 ± 4.04 9 (23.7) 20 (52.6) 7 (18.4) 1 (2.6) 1 (2.6)
Smoke, %	30 (78.9)
Hypertension, %	27 (71.1)
Diabetes, %	3 (7.9)
Dyslipidemia, %	9 (23.7)
GFR > 60ml/min, %	35 (92.1)
Previous MI, %	7 (18.4)
Coronary disease, %	10 (26.3)
Valvular disease, %	2 (5.3)
NYHA I, % NYHA II, %	28 (73.7) 10 (26.3)
Peripheral artery disease, %	4 (10.5)
COPD, %	3 (7.9)
Cancer, %	1 (2.6)
LVEF, mean ± SD, %	60 ± 11
LVEF > 45%, %	36 (94.7)
Main diagnostic Aneurysm, % Biggest diameter of the anuerysm, median [IQR], mm, Smallest diameter of the aneurysm, median [IQR], mm Narrowest point (neck), median [IQR], mm Location Crawford I, % Crawford II, % Crawford IV, % Dissecting aneurysm, % Dissection Stanford A/DeBakey I, % Stanford B/DeBakey III, % Penetrating ulcer, %	25 (65.8) 63 [51, 74] 57.5 [49.25, 70.5] 22 [14.75, 25] 7 (28) 3 (12) 15 (60) 3 (12.5) 13 (34.2) 3 (23.1) 8 (61.5) 2 (15.4)
Concomitant findings associated to main diagnostic Aneurysm, % Dissection, % Penetrating ulcer, % Intramular haematoma, % Other, %	30 (78.9) 14 (36.8) 4 (10.5) 7 (18.4) 1 (2.6)
Other vessels involvement Celiac trunk, % Supra-aortic arch, % Left renal artery, % Right renal artery, % Inferior mesenteric artery, % Right femoral, % Both iliacs, % Right iliac, % Hepatic artery, %	4 (10.5) 2 (5.2) 1 (2.6) 5 (13.1) 1 (2.6) 1 (2.6) 6 (15.7) 3 (7.8) 1 (2.6)
BMI = Body mass index; kg/m² = kilograms per square meters; GFR = Glomerular Filtration Rate; MI = Myocardial infarction; NYHA = New York Heart Association Functional Class; COPD = Chronic Obstructive Pulmonary Disease; LVEF = Left Ventricular Ejection Fraction; SD = Standard deviation; IQR = Interquartile Range; mm = millimeters

Procedural characteristics are described in Table 2. Urgent treatment was needed in 31.6%, median contrast medium was 345 [245, 427] mL, and the number of endoprosthesis used was 2.13 [1, 5] per patient. The most used endoprosthesis was Valiant Captivia™ (Medtronic, Minneapolis, USA) (36.8%) followed by Cook Zenith® (Cook Medical, Indiana, USA) (18.4%) and Endurant™ (Medtronic, Minneapolis, USA) (15.8%). Additional procedure was performed in 65.8% of patients (see in detail in Table 2).

Table 2

Procedural characteristics
	N = 38 (%)
Urgent treatment	12 (31.6)
Contrast media, median [IQR], mL	345 [245, 427]
Number of endoprostheses, median [IQR]	2.13 [1, 5]
Total endoprosthesis length, median [IQR], mm	237.5 [186.25, 367.75]
Biggest endoprosthesis diameter, median [IQR], mm	34 [28, 40]
Smallest endoprosthesis diameter, median [IQR], mm	32 [16, 36.5]
Other endoprosthesis diameter, median [IQR], mm	20 [16, 38]
Type of endoprostheses Atrium Cast Valiant Captivia Gore Viabahn Cook Zenith Rely plus Endurant Gore Excluder	1 (2.6) 14 (36.8) 3 (7.9) 7 (18.4) 5 (13.2) 6 (15.8) 2 (5.3)
Other procedure One procedure (endoprosthesis) Femoro-femoral bridge Aortic-valve tube Arterial coil Carotid deviation Cartotid-subclavian deviation Carotid stent Subclavian plug Femoral intervention with Gorotex tube Renal stent Iliac angioplasty Iliac stent Palmaz stent Cuff occluder Iliac extension Debranching with carotid-carotid anastomosis	13 (34.2) 2 (5.2) 2 (5.2) 3 (7.8) 4 (10.5) 1 (2.6) 1 (2.6) 1 (2.6) 1 (2.6) 3 (7.8) 3 (7.8) 2 (5.2) 1 (3.2) 1 (3.2) 6 (15.7) 3 (7.8)
IQR = Interquartile Range; mm = millimeters; mL = milliliters.

In-hospital complications are described in Table 3. From 38 treated patients, 25 were treated due to AA and 13 due to AD. Comparing patients treated due to AA and AD, there was no difference regarding type A1 endoleak (8% vs. 15.4%, p = 0.59), mayor bleeding (36% vs. 46.2%, p = 0.54), conversion to surgery (4% vs. 0%, p = > 0.99), endovascular reintervention (16% vs. 15.4%, p = > 0.99), or vascular complication (8% vs. 15.4%, p = 0.59), respectively. There was no difference between groups (AA vs. AD) regarding in-hospital clinical complications (pneumonia 8% vs. 15.4%, p = 0.59; acute renal failure 20% vs. 30.8%, p = 0.68; anemia 52% vs. 61.5%, p = 0.73). Three patients presented cardiac arrets after procedure in the AA group (12% vs. 0% in AD group, p = 0.53). Overall hospital stay was 16.5 [6.75, 26.25] days, with more days on the AD group that in the AA group [26 (18, 34.5) vs. 9 (6, 20.5) days, p = < 0.01 respectively].

Table 3

In-hospital complications
	All n = 38	Aneurysm n = 25	Dissection n = 13	p value
In-hospital mortality Type 1A endoleak Bleeding Minor bleeding Mayor bleeding Conversion to surgery Endovascular reintervention Graft thrombosis Abdominal surgery Spinal-cord injury Vascular complication	0 (0) 4 (10.5) 22 (57.9) 7 (18.4) 15 (39.5) 1 (2.6) 6 (15.8) 3 (7.9) 1 (2.6) 2 (5.3) 4 (10.5)	0 (0) 2 (8) 15 (60) 6 (24) 9 (36) 1 (4) 4 (16) 3 (12) 1 (4) 0 (0) 2 (8)	0 (0) 2 (15.4) 7 (53.8) 1 (7.7) 6 (46.2) 0 (0) 2 (15.4) 0 (0) 0 (0) 2 (15.4) 2 (15.4)	NA 0.59* 0.71^# 0.38* 0.54^# > 0.99* > 0.99* 0.53 > 0.99* 0.11* 0.59*
Pneumonia Acute renal failure Acute peripheral vascular obstruction Anemia Cardiac arrest	4 (10.5) 9 (23.7) 3 (7.9) 21 (55.3) 3 (7.9)	2 (8) 5 (20) 1 (4) 13 (52) 3 (12)	2 (15.4) 4 (30.8) 2 (15.4) 8 (61.5) 0 (0)	0.59* 0.68* 0.26* 0.73* 0.53*
Total hospital stay, median [IQR], days Intensive care stay, median [IQR], days	16.5 [6.75, 26.25] 3 [1, 8.25]	9 [6; 20.5] 2 [1; 4.5]	26 [18, 34.5] 8 [4.5, 16]	< 0.001^& < 0.001^&
* Fisher; ^# Chi²; ^& U Mann-Whitney; NA = Non-applicable

There was no in-hospital or 30 days mortality observed. Thirty days follow up is described in Table 4. Thirty days re-hospitalization rate was more observed in AD group compared to AA group (46.2% vs. 32%, p = 0.39, respectively). The main cause of re-hospitalization was vascular access site pain (AD 30.8% vs. AA 20%, p = 0.68).

Table 4

Thirty days follow-up
	All n = 38	Aneurysm n = 25	Dissection n = 13	p* value
30-days mortality	0	0	0	NA
Any cause re-hospitalisation	14 (36.8)	8 (32)	6 (46.2)	0.39
Re-hospitalization cause Vascular access site pain Percutaneous reintervention Vascular repair Bleeding	9 (23.6) 1 (2.6) 1 (2.6) 3 (7.8)	5 (20) 1 (4) 0 (0) 2 (8)	4 (30.8) 0 (0) 1 (7.7) 1 (7.7)	0.68 > 0.99 0.34 > 0.99
* Fischer test; NA = Non-applicable

In this single centre analysis, treating patients with AA and AD, the use of transcatheter EVAR approach showed no in-hospital mortality, with comparable and low complications rates after procedure between AA and AD. Three cases presented cardiac arrest, that needed cardiac resuscitation less than one minute. Two patients had volume depletion, and one patient was associated to acute renal failure. Anemia secondary to bleeding and major bleeding was the most common in-hospital complication rate, but no life-threating or major bleeding requiring intervention was observed in any group. Complications associated to intervention, i.e. conversion to surgery, graft thrombosis, spinal-cord injury or vascular complications remained low, while endovascular reintervention remained comparable between AA and AD groups. Thirty days follow up showed no severe EVAR-related complications, observing vascular access site pain as the most common cause to require hospitalization after discharge with conservative management for pain relieve.

Interestingly, there was no in-hospital or 30-days mortality observed in our patients. Thirty days mortality rate has been described to be as high as 27% in patients presenting with thoracic or abdominal aortic rupture(7), and as low as 4% in those patients with chronic thoracic and abdominal disease(12), while higher mortality rate in EVAR patients is associated with infection(13). Thirty das mortality rates has been reached 9% after EVAR and only 1.7% in those without intervention, but with a rupture aneurysma rate of 9 per 100 persons years(14). The EVAR trial 1(15) reported a six-months lower aneurysm-related mortality rate in EVAR group compared with open repair (2% vs. 5%, p = 0.031, respectively). In patients with type B A, 12-months mortality was relative higher compared with optimal medical therapy (OMT) (6.9% vs 2.9%, p = 0.44, respectively), but after two year, EVAR revealed beneficial prognostic benefit in comparison to OMT(16). The higher mortality rates seen in OMT patients seems to be related to AA or AD complications.

In-hospital complications were comparable between patients with AA and AD. The most observed complication was bleeding, especially in AA, but major bleeding complication was more common in AD treated patients. This is explained by the nature of the disease, where small ruptures from the aortic walls due to dissection are more labile to cause hemorrhage and hence major bleeding. This complication also explains endovascular re-intervention as the second most seen complication. As bleeding and endoleak are related each-other, re-intervention was used to approach and treat the cause. We observed an endoleak type 1a rate of 8% in AA patients and 15.4% in AD patients. Similar 8% has been reported by Thomas et al.(17), using ballooning of the proximal site in 43% of the cases or a Palmaz Stent in 25% of the cases, with 35% rate of remained endoleak, persisting only 6% at one year, while other authors have reported 21% of endoleak type 1a(18), with an estimated overall success rate after reintervention of 91% at 19 months but 12% of surgical re-intervention(19). In our center, there was only one patient requiring surgical re-intervention after AA repair, after vascular and major bleeding complication, with successful outcome.

Study Limitations

The current analysis is limited by the single-centre observational and retrospective nature of the investigation, and its susceptibility to selection bias. The lack of a core lab for CT analysis, the different type of aortic disease, the reduce number of patients included in the analysis and the short follow up period represents a limitation of the study.

EVAR represents a safe procedure in patients presenting with AA or AD, with no in-hospital or 30 days mortality rate after procedure. Although there was a trend of more endoleak in patients treated after AD, reintervention rate is low. Rehospitalizations EVAR-related represents a minor concern, and no major or mortality related complications were associated.

AA Aortic Aneurysm

AD Aortic Dissection

CT Computed tomography

EVAR Endovascular Aortic Repair

IMH Intramural Haematoma

PAU Penetrating Aortic Ulcer

Ethics approval and consent to participate

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. For this type of study formal consent is not required. This study has obtained IRB approval from (local ethics committee from the Hospital de Cardiología, Centro Médico Nacional Siglo XXI under the number R-2017-3604-78) and the need for informed consent was waived.

Consent for publication

Not applicable.

Availability of data and materials

Not applicable.

Competing interests

“The authors declare that they have no competing interests”

Funding

This study was not supported by any funding.

Authors' contributions

All authors contributed to the study conception and design. Conceptualization: HAAC and SAMG; Methodology: HAAC and JUG; Formal analysis and investigation: HAAC; Writing - original draft preparation: HAAC and JEG; Writing - review and editing: HAAC and GSC; Supervision: HAAC, JEG and GSC.

Acknowledgements

Not applicable.

Availability of data and materials

Not applicable.

Disclosures

The authors have no conflicts of interest to declare.

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No competing interests reported.

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Endovascular repair in patients with aortic dissection and aortic aneurysm: A retrospective cohort study.

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Abstract

Background

Methods

Results

Conclusions

Figures

Introduction

Methods

Study Population

Endpoints

Statistical analysis

Results

Discussion

Study Limitations

Conclusions

Abbreviations

Declarations

References

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