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Endovascular Treatment of Complex Aortic Pathologies – The Importance of Adequate Patient Selection and Thorough Evaluation of Novel Techniques
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Vascular Surgery. (Vascular Surgery)ORCID iD: 0000-0002-6445-0575
2023 (English)Doctoral thesis, comprehensive summary (Other academic)
Description
Abstract [en]

Aortic pathologies include a broad spectrum of diseases, whose inci-dence, prevalence and mortality typically increases with age. Traditional-ly, open surgery was the only viable treatment solution. However, endo-vascular repair has revolutionized aortic treatment, with ever-increasing available devices, more developed techniques, and improved patient outcomes. The combination of an aging population and improving out-comes has led to an ever-increasing number of patients being offered - and ultimately undergoing – treatments, for which 20 years ago they would have been considered too “high-risk”. The past years have also seen significant strides in innovation and technical device feasibility. However, in conjunction with the development of new systems and technologies, an increase in the number of device recalls from the mar-ket has occurred. Is the broadening of patient selection criteria and novel devices really associated with improved outcomes? As these techniques continue to break new boundaries, adequate patient selection and thor-ough assessment of novel technologies becomes only more vital.

The aim of this PhD is therefore to 1) evaluate the effect of age on the outcomes of aortic endovascular treatment; and 2) to expand our knowledge of outcomes following the implementation of novel technolo-gies used for endovascular aortic treatments.   

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2023. , p. 69
Series
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 1941
Keywords [en]
Endovascular, Aortic, Aneurysm, Dissection, Minimally Invasive, Endograft
National Category
Cardiology and Cardiovascular Disease
Identifiers
URN: urn:nbn:se:uu:diva-500192ISBN: 978-91-513-1791-5 (print)OAI: oai:DiVA.org:uu-500192DiVA, id: diva2:1750282
Public defence
2023-06-02, H:sson Holmdahls-salen, Ingång 100/101, Dag Hammarskjölds Väg 8, Uppsala, 13:00 (English)
Opponent
Supervisors
Available from: 2023-05-09 Created: 2023-04-12 Last updated: 2025-02-10
List of papers
1. International Collaborative Study Reporting Outcomes on Fenestrated Endovascular Aortic Repair in OCtogenarian Patients: The FEVOC study
Open this publication in new window or tab >>International Collaborative Study Reporting Outcomes on Fenestrated Endovascular Aortic Repair in OCtogenarian Patients: The FEVOC study
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(English)Manuscript (preprint) (Other academic)
Abstract [en]

Objective: With an increasing life expectancy, more octogenarian patients are referred with complex aortic aneurysms (cAAA). The aim of this study was to evaluate short and mid-term outcomes following fenestrated aortic repair (FEVAR) in octogenarians.

Methods: Retrospective, multicentre cohort study including 8 centres across Europe and New Zealand. Consecutive patients undergoing elective FEVAR for the treatment of juxta/pararenal or type IV thoracoabdominal aortic aneurysms between 2013 and 2021 were included. The primary outcome was 30-day mortality. Secondary outcomes included 1, 2 and 5-year survival rates and mid-to-long term reintervention rates.

Results: A total of 729 patients were included, of which 169 were octogenarians. Octogenarian patients were more frequently male and had larger (61mm vs. 58mm) aneurysms. No differences in 30-day mortality (4.7% vs. 3.9%) or 30-day complication rates (29% vs 28.4%) were found. Median follow-up was 23.56 months. The 1, 2 and 5-year survival rates for octogenarian vs nonoctogenarian patients were 90.7%, 80.1% and 40.1% vs. 90.2%, 85.5% and 68.1%, respectively (p=.001). Cox regression analysis found a BMI ≥ 30 (HR 0.50, 95% CI 0.28-0.88), chronic heart failure (HR 2.14, 95% CI 1.04 – 4.39) and AAA diameter between 60-70mm (HR 2.35, 95% CI 1.31 – 4.23) to be predictors of longterm mortality.

Conclusions: Thirty-day outcomes after FEVAR were similar in octogenarians and younger patients. However, mid to long term survival rates, especially after 3 years, are considerably low in both groups. Whilst FEVAR in octogenarians can be performed safely and with good early outcomes, methods to improve case selection and ensure patient benefit in the long term are highly of interest.

National Category
Cardiology and Cardiovascular Disease
Research subject
Medical Science; Surgery
Identifiers
urn:nbn:se:uu:diva-500002 (URN)
Available from: 2023-04-10 Created: 2023-04-10 Last updated: 2025-02-10Bibliographically approved
2. Pre-Loaded Fenestrated Thoracic Endografts for Distal Aortic Arch Pathologies: Multicentre Retrospective Analysis of Short and Mid Term Outcomes
Open this publication in new window or tab >>Pre-Loaded Fenestrated Thoracic Endografts for Distal Aortic Arch Pathologies: Multicentre Retrospective Analysis of Short and Mid Term Outcomes
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2021 (English)In: European Journal of Vascular and Endovascular Surgery, ISSN 1078-5884, E-ISSN 1532-2165, Vol. 62, no 6, p. 887-895Article in journal (Refereed) Published
Abstract [en]

Objective: To determine short and midterm outcomes of a pre-loaded fenestrated thoracic endograft (f-TEVAR) for exclusion of distal aortic arch pathologies.

Methods: This was a multicentre, retrospective study including consecutive patients from six experienced European vascular centres undergoing f-TEVAR for distal arch pathologies. Primary endpoints included peri-operative mortality and peri-operative stroke and/or spinal cord ischaemia rates. Secondary outcomes were technical success and mid to late events, including death and re-interventions. Statistical analysis was performed with SPSS 26. Mid to late term events were calculated using Kaplan-Meier survival analysis.

Results: One hundred and eight patients were included (mean age 68 ± 11 years, 70% men). A total of 38% (n = 42) had a prior history of aortic dissection, and 24% (n = 26) prior aortic surgery. The mean aneurysm diameter was 59 ± 12 mm and the most frequent indication for treatment was post-dissection aneurysms (n = 42, 39%). Technical success was 99% (n = 107) despite intra-operative wire entanglement occurring in 29% (n = 31). The 30 day mortality rate was 3.7% (n = 4), with a 5.6% major stroke incidence (n = 6) and 3.7% (n = 4) spinal cord ischaemia rate. Three cases of retrograde dissection occurred (two of which were fatal), all in post-type B dissecting aneurysm patients without prior aortic surgery (three of 19, 15.8%). Median follow up was 12 months (range, 1 - 26). Endoleaks were documented during follow up, with 3.5% type Ia (4/104) and 2.9% type Ib (3/104) as a result of persistent false lumen perfusion. The one, two, and three year survivals and freedom from re-intervention rates were 93.2% and 92.1%, 89.1% and 86.3%, and 84.4% and 73%, respectively.

Cconclusion: This multicentre study shows that treatment of the distal aortic arch by f-TEVAR is feasible, with promising 30 day mortality, stroke, and spinal cord ischaemia rates.

Place, publisher, year, edition, pages
Elsevier, 2021
Keywords
Aneurysm, Aorta, Arch repair, Endovascular, Fenestrated, Post-dissecting
National Category
Surgery Cardiology and Cardiovascular Disease
Identifiers
urn:nbn:se:uu:diva-499661 (URN)10.1016/j.ejvs.2021.08.018 (DOI)000731065700014 ()
Available from: 2023-04-03 Created: 2023-04-03 Last updated: 2025-02-10Bibliographically approved
3. A systematic review of experimental and clinical studies reporting on in situ laser fenestration of aortic endografts.
Open this publication in new window or tab >>A systematic review of experimental and clinical studies reporting on in situ laser fenestration of aortic endografts.
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2022 (English)In: Journal of Vascular Surgery, ISSN 0741-5214, E-ISSN 1097-6809, Vol. 75, no 2, p. 740-752.e1, article id S0741-5214(21)02190-XArticle in journal (Refereed) Published
Abstract [en]

OBJECTIVE: To summarize available in-situ laser fenestration (ISLF) literature, including experimental studies with their subsequent recommendations regarding optimal fenestration technique and fabric; as well as the short and mid-term results of clinical studies.

METHODS: A systematic review of English articles was performed in MEDLINE, the Cochrane Database and EMBASE, following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines by two researchers. The search period was without starting date until the 31st August 2020, and search terms included were in situ, laser, fenestration, and endograft. Quality assessment of the studies was performed using the Newcastle-Ottawa scale by two other independent researchers.

RESULTS: A total of 19 clinical studies were included, with a total of 428 patients (390 supra-aortic trunk ISLF, 38 visceral vessel ISLF). The technical success was 96.9% and 95.6% supra-aortic and visceral vessel ISLF, respectively. Most studies have less than 12-month follow-up, and the longest available follow-up (in one study) was 5-years for left-subclavian fenestration and 17-months for visceral vessel ISLF. Overall, the quality of the evaluated clinical studies was low. Six experimental studies were included, with the highest level of evidence suggesting fenestration of multifilament polyethylene terephthalate grafts, followed by dilation with either a 6- or 8-mm non-compliant balloon.

CONCLUSION: Experimental studies favour the use of multifilament polyethylene terephthalate , followed by dilation with non-compliant balloons as the most durable "in-vitro" technique for ISLF. Short-term outcomes for arch and visceral vessel revascularization are promising, with low rates of in-hospital mortality, stroke, and end-organ ischemia. Nonetheless, the long-term durability of ISLF is yet to be determined and they should be limited to selected symptomatic or urgent cases.

Place, publisher, year, edition, pages
ElsevierElsevier BV, 2022
Keywords
Aortic Aneurysms, Endovascular aortic repair, Fenestration, Innovative techniques, Laser, Surgeon modified grafts
National Category
Surgery Cardiology and Cardiovascular Disease
Identifiers
urn:nbn:se:uu:diva-459192 (URN)10.1016/j.jvs.2021.09.031 (DOI)000746023000048 ()34634422 (PubMedID)
Available from: 2021-11-22 Created: 2021-11-22 Last updated: 2025-02-10Bibliographically approved
4. Endovascular Aortic Repair in Nonagenarian Patients
Open this publication in new window or tab >>Endovascular Aortic Repair in Nonagenarian Patients
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2021 (English)In: Journal of the American College of Cardiology, ISSN 0735-1097, E-ISSN 1558-3597, Vol. 77, no 15, p. 1891-1899Article in journal (Refereed) Published
Abstract [en]

Background

The increasing proportion of elderly patients being treated for abdominal aortic aneurysm (AAA) in the endovascular era is controversial.

Objectives

This study compared 30-day outcomes of endovascular aortic repair (EVAR) in nonagenarians (NAs) with non-nonagenarians (NNAs).

Methods

This retrospective analysis of the American College of Surgeons National Surgical Quality Improvement Program database included EVAR procedures performed from 2011 to 2017. Multivariate logistic regression in the unadjusted cohort, followed by propensity-score matching (PSM), was performed. Primary outcomes were 30-day mortality and 30-day major adverse events.

Results

A total of 12,267 patients were included (365 NAs). Ruptured aneurysms accounted for 6.7% (n = 819): 15.7% (n = 57) in NAs versus 6.5% (n = 762) in NNAs (p < 0.001). Mean aneurysm diameter was 6.5 ± 1.8 cm in NAs versus 5.8 ± 1.7 cm in NNAs (p < 0.001). The unadjusted 30-day mortality was 9.9% in NA versus 2.2% in NNAs (p < 0.001). Multivariate analysis revealed age ≥90 years (odds ratio [OR]: 3.36), male sex (OR: 1.78), functional status (OR: 4.22), pre-operative ventilator dependency (OR: 3.80), bleeding disorders (OR: 1.52), dialysis (OR: 2.56), and ruptured aneurysms (OR: 17.21) as independent predictors of mortality. After PSM, no differences in 30-day mortality (intact AAA [iAAA]: 5.3% NA vs. 3% NNA [p = 0.15]; ruptured AAA [rAAA]: 38% NA vs. 28.6% NNA [p = 0.32]) or 30-day major adverse events (iAAA: 7% NA vs. 4.6% NNA [p = 0.22]; rAAA: 28% NA vs. 36.7% NNA [p = 0.35]) were observed.

Conclusions

Age was identified as an independent predictor of 30-day mortality after EVAR on multivariate analysis. However, no differences were found after PSM, suggesting that being ≥90 years of age but with similar comorbidities to younger patients is not associated with a higher short-term mortality after EVAR. Age ≥90 years alone should not exclude patients from EVAR, and tailored indications and carefully balanced risk assessment are advised.

Place, publisher, year, edition, pages
Elsevier, 2021
Keywords
elderly population, endovascular aortic repair, nonagenarians, NSQIP, ruptures, aortic aneurysms
National Category
Cardiology and Cardiovascular Disease Surgery
Identifiers
urn:nbn:se:uu:diva-499659 (URN)10.1016/j.jacc.2021.02.042 (DOI)000640242300007 ()
Available from: 2023-04-03 Created: 2023-04-03 Last updated: 2025-02-10Bibliographically approved
5. "In vitro" evaluation of the optimal degree of oversizing of thoracic endografts in prosthetic landing areas: A Pilot Study
Open this publication in new window or tab >>"In vitro" evaluation of the optimal degree of oversizing of thoracic endografts in prosthetic landing areas: A Pilot Study
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(English)Manuscript (preprint) (Other academic)
Abstract [en]

Objectives: The optimal degree of proximal thoracic endograft oversizing when aiming for durable sealing in prosthetic grafts in unknown. The aim of this study was to create an in vitro model for testing different oversized thoracic endografts in a reproducible and standardized manner, and subsequently determining the optimal oversizing range when planning procedures with proximal landing in prosthetic zones in the descending thoracic aorta or aortic arch.

Materials and Methods: An in-vitro model consisting of a fixated 24mm polyethylene terephthalate (Dacron) graft sutured proximally and distally to two specifically designed 40mm rings, with four force sensing resistors attached at 4 equally distant positions and a USB camera attached proximally for photographic and video documentation was used for deployment of Zenith TX2 (Cook Medical, Bloomington, IN, USA) dissection platform endografts with diameters between 24 and 36mm. After deployment, ballooning with a 32mm compliant balloon was performed to simulate real life conditions. Assessment of oversizing included visual inspection, calculation of the valley areas created between the prosthetic wall and the stentgraft fabric, distance between stentgraft peaks, radial force exerted by the proximal sealing stent and the pull-out force necessary for endograft extraction.

Results: A total of 70 endografts were deployed: 10x 24mm, 10x 26mm, 10x 28mm, 10x30mm, 10x32mm, 10x34mm and 10x36mm, with oversizing ranging between 0-50%. Two cases of infolding occurred with 50% oversizing. Valley areas increased from 8.79 ± 0,23 mm with 16.7% oversizing to 14.26 ± 0.45 mmÇ for 50% oversizing (p<.001). There was a significant difference in the pull-out force required for endografts <10% oversizing vs. 10% oversizing or more (p<.001), which reached a plateau at approximately 4 N after oversizing > 15%. The mean radial force of the proximal sealing stent was greater after remodelling with a compliant balloon (.55 ± .02 N vs .60 ± .02 N after ballooning (p<.001)). However, larger oversizing did not lead to an increase in the radial force exerted by the proximal sealing stent.

Conclusion: The findings of this study offer additional insight into the mechanics of oversized stentgrafts in surgical grafts. In endografts with the z-stent design (TX2), oversizing below 16.7% resulted in reduced resistance to displacement forces, while oversizing > 50% was associated to major infolding in 20% of the cases. Long-term in vitro and in vivo testing are required to understand how these mechanical properties impact clinical outcomes of oversizing.

National Category
Cardiology and Cardiovascular Disease
Research subject
Medical Science; Medical Science
Identifiers
urn:nbn:se:uu:diva-500003 (URN)
Note

De två första författarna delar förstaförfattarskapet

Available from: 2023-04-10 Created: 2023-04-10 Last updated: 2025-02-10Bibliographically approved

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