| 1. |
- Burdess, Anne, et al.
(author)
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Early Experience With a Novel Dissection-Specific Stent-Graft to Prevent Distal Stent-Graft-Induced New Entry Tears After Thoracic Endovascular Repair of Chronic Type B Aortic Dissections
- 2022
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In: Annals of Vascular Surgery. - : Elsevier. - 0890-5096 .- 1615-5947. ; 81, s. 36-47
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Journal article (peer-reviewed)abstract
- Background: The aim was to report short and mid-term outcomes of a novel, investigational, dissection-specific stent-graft (DSSG), specifically designed to address the features of chronic type B aortic dissection (CTBAD) and reduce the risk of distal stent-graft-induced new entry tears (dSINE).Materials and Methods: A retrospective single center cohort study of all patients undergoing TEVAR with the DSSG for CTBAD from January 1, 2017 to January 31, 2020. The DSSG, which is a modified stent-graft based on the Cook Zenith Alpha Thoracic platform, has no proximal barbs, and a customized longer body length with substantial taper. The second and third distal Z-stents are sited internally to avoid any contact of the metal skeleton with the dissection membrane and have reduced radial force, while the most distal stent was removed creating a distal 30 mm unsupported Dacron graft.Results: Sixteen patients (13 males, 3 females) with a median age of 66 years (range 31–79 years) underwent elective TEVAR of CTBAD using the DSSG. Six patients (38%) had an underlying connective tissue disorder. The median tapering was 10 mm (range 4 mm–21 mm) and median length 270 mm (range 210–380 mm). Technical success was achieved in all but one case (96%). One patient died within 30 days, due to retrograde type A dissection with cardiac tamponade. The 30-day rate of stroke, spinal cord ischemia, and re-interventions was 0%. After median imaging follow-up time of 17 months (range 1–31 months), one patient developed a dSINE 4 months after the index procedure. After median survival follow-up of 23 months (range 2–35 months), one late death occurred due to traumatic brain injury, while no aortic-related death occurred during follow-up. Complete false lumen (FL) thrombosis was achieved in 9 patients while the remaining 6 showed partial FL thrombosis. No instances of diameter increase at the level oftreated aortic segment were noted with serial measurements showing either stable (n = 7) or decreased (n = 8) maximal transverse diameter.Conclusions: Use of a novel DSSG with low radial force for TEVAR in the setting of CTBAD is safe and feasible. This early real-world experience shows promising mid-term effectiveness with low rates of dSINE or unplanned re-interventions and satisfactory aortic remodeling during follow-up. Longer follow-up is needed, however, before any firm conclusions can be drawn.
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| 4. |
- Burdess, Anne, et al.
(author)
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Stent-graft induced new entry tears after type B aortic dissection : how to treat and how to prevent?
- 2018
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In: Journal of Cardiovascular Surgery. - : EDIZIONI MINERVA MEDICA. - 0021-9509 .- 1827-191X. ; 59:6, s. 789-796
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Research review (peer-reviewed)abstract
- Progress of aortic disease after stent-graft treatment of aortic dissection includes the risk of stent graft-induced new entry (SINE). In this paper we review the incidence and mechanisms thought to be responsible for retrograde ascending and distal SINE after thoracic endovascular aortic repair (TEVAR) for type B dissection, and examine potential techniques for treatment and prevention. Although the risk of proximal SINE is low, the fatality of this complication requires vigilance in patients who develop new onset symptoms in the early period after TEVAR treatment. Careful technique, minimal oversizing, and use of disease specific stent grafts may reduce the risk for proximal SINE. Distally, SINE is more frequently seen during follow-up in patients treated for chronic dissection. The most important risk factor is oversizing of the stent-graft compared to the true lumen distal landing zone. Development of new disease specific stent grafts with reduced distal radial force may reduce the risk for distal SINE.
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| 5. |
- D'Oria, Mario, et al.
(author)
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Pre-Operative Moderate to Severe Chronic Kidney Disease is Associated with Worse Short-Term and Mid-Term Outcomes in Patients Undergoing Fenestrated-Branched Endovascular Aortic Repair
- 2021
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In: European Journal of Vascular and Endovascular Surgery. - : Elsevier. - 1078-5884 .- 1532-2165. ; 62:6, s. 859-868
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Journal article (peer-reviewed)abstract
- OBJECTIVE: To review experience of fenestrated-branched endovascular aortic repair (F-BEVAR) for pararenal/thoraco-abdominal aortic aneurysms (PRAA/TAAA) and to assess the association between pre-operative moderate to severe chronic kidney disease (CKD) and post-operative outcomes.METHODS: All consecutive patients undergoing (elective and non-elective) F-BEVAR at a single centre (1 January 2011 - 1 July 2019) were identified. Renal function was calculated as the estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease formula. Accordingly, presence of moderate to severe CKD was defined as eGFR < 60 mL/min/1.73m2.RESULTS: Overall, 202 consecutive patients (mean age 72 ± 8 years; 25% women) underwent F-BEVAR for the treatment of PRAA/TAAA during the study period. Of these, 51 had a history of moderate to severe CKD (none on chronic haemodialysis). No statistically significant differences were found in demographics and major comorbidities between patients with or without a history of CKD. The overall peri-operative mortality rate was 2%, without statistically significant differences between study groups (p = .26). Patients with prior CKD had statistically significantly higher rates of acute kidney injury (AKI) (37% vs. 12%, p < .001). At three years, overall survival was statistically significantly lower in patients with history of CKD compared with those without pre-operative CKD (57% vs. 82%, p = .010). Similarly, freedom from renal function decline at three years was statistically significantly poorer in patients with prior history of CKD compared with those without pre-operative CKD (43% vs. 80%, p = .020). In a multivariable analysis CKD was independently associated with higher odds of peri-operative AKI (OR 2.8, 95% CI 1.9 - 5.8, p = .030), renal function decline (OR 4.9, 95% CI 1.7 - 9.2, p = .003), and all cause mortality (HR 3.2, 95% CI 1.2 - 8.6, p = .020).CONCLUSION: Despite low peri-operative mortality rates that are comparable to patients with unimpaired renal function, occurrence of AKI was statistically significantly higher in subjects with pre-existing moderate to severe CKD. History of CKD was independently associated to renal function decline and poorer midterm survival.
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| 6. |
- D'Oria, Mario, et al.
(author)
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Short-term and Mid-term Outcomes after Use of the Native Infrarenal Aorta as Distal Landing Zone for Fenestrated-Branched Endovascular Aortic Repair
- 2021
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In: Annals of Vascular Surgery. - : Elsevier. - 0890-5096 .- 1615-5947. ; 72, s. 114-123
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Journal article (peer-reviewed)abstract
- Background: This study aimed to examine outcomes after use of the native infrarenal aorta as distal landing zone for fenestrated-branched endovascular aortic repair (F-BEVAR) of pararenal-thoracoabdominal aortic aneurysms (PRAA-TAAA). Methods: All F-BEVAR procedures for treatment of PRAA-TAAA (2011-2019) at 2 aortic centers were examined. The outcomes of interest were as follows: i) technical success, ii) perioperative morbidity, iii) preservation of lumbar arteries and the inferior mesenteric artery, iv) type IB endoleaks, v) reinterventions, vi) survival, vii) aneurysm sac behavior, and viii) infrarenal aortic changes. Results: Twenty consecutive patients with distal landing in the native infrarenal aorta were included (median age 71 years; 25% men). The median number of visible lumbar arteries at baseline was 7, and a patent inferior mesenteric artery (IMA) before the operation was present in 19 (95%) of the cases. There were no deaths within 30 days. One patient (5%), operated on with a 4-BEVAR for a type 2 TAAA, experienced spinal cord ischemia (permanent paraplegia). The median decrease in the number of visible lumbar arteries at the first postoperative scan was 3 from the baseline value, whereas a patent IMA was preserved in 12 out of 19 patients. Only in one case (5%), a type IB endoleak was noted for an overall technical success rate of 95%, which required a standard EVAR 20 months after the initial operation. The median follow-up duration for the study cohort was 491 days; all patients were alive at the longest available individual follow-up, and no instances of new-onset type IB endoleaks were observed. Another 3 late reinterventions (in addition to the one mentioned previously) were performed during midterm follow-up, all because of target vessel instability. In patients with >= 12 months of follow-up after the index procedure (n = 12, 60% of the entire cohort), no instances of aneurysm sac increase >5 mm were noted; the median largest aortic diameter was 51 mm with a median difference from baseline of -6 mm. The median distal landing zone diameter increase was 4 mm from baseline but never beyond the nominal stent-graft diameter, whereas the median aortic bifurcation diameter differed 1 mm from baseline. Conclusions: This preliminary experience shows that the use of the native infrarenal aorta as a distal landing zone for F-BEVAR is safe in the short term and midterm in patients with suitable anatomy, allowing the sparing of collateral vessels. Longer follow-up is warranted to assess durability.
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| 7. |
- Estrada, Sergio, et al.
(author)
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Preclinical evaluation of [C-11]GW457427 as a tracer for neutrophil elastase
- 2022
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In: Nuclear Medicine and Biology. - : Elsevier. - 0969-8051 .- 1872-9614. ; 106-107, s. 62-71
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Journal article (peer-reviewed)abstract
- Introduction: Neutrophils are part of the innate immune system and function as a first line of defense against invading microorganisms. Overactivity of the immune system may result in a devastating immuno-inflammation with extensive damage to tissue leading to organ damage and/or failure. The literature suggests several human diseases in which neutrophil elastase (NE) is postulated to be important in the pathophysiology including inflammatory bowel disease (IBD), chronic obstructive pulmonary disorder (COPD), abdominal aortic aneurysms (AAA), breast and lung cancer, and recently also in Sars-cov-2 virus infection (Covid-19). In particular, the lungs are affected by the destructive power of the protease neutrophil elastase (NE). In this paper, we report the pre-clinical development of a selective and specific positron emission tomography (PET) tracer, [C-11] GW457427, as an in vivo biomarker for the study of NE, now available for human studies.Methods: [C-11]GW457427 was produced by methylation of GW447631 using [C-11]methyl triflate and GMP validated production and quality control methods were developed. Chemical purity was high with no traces of the precursor GW611437 or other uv-absorbing compounds. A method for the determination of intact [C-11] GW457427 in plasma was developed and the binding characteristics were evaluated in vitro and in vivo. An animal model for lung inflammation was used to investigate the specificity and sensitivity of the [C-11]GW457427 tracer for neutrophil elastase (NE) in pulmonary inflammation, verified by blockade using two structurally different elastase inhibitors.Results: [C-11]GW457427 was obtained in approximately 45% radiochemical yield and with a radiochemical purity higher than 98%. Molar activity was in the range 130-360 GBq/mu mol. Binding to NE was shown to be highly specific both in vitro and in vivo and a significantly higher uptake of tracer was found in a lipopolysaccharide mouse model of pulmonary inflammation compared with control animals. The uptake in lung tissue measured as standardized uptake value (SUV) strongly correlated with tissue NE content as measured by ELISA. In vitro studies also showed specific tracer binding in aortic tissue of patients with abdominal aorta aneurysm (AAA). The rate of metabolism in rats was appropriate considering the critical balance between available tracer for binding and requirement for blood clearance with about 40% and 20% intact [C-11]GW457427 in plasma at 5 and 40 min, respectively. Radioactivity was cleared from blood and organs in control animals with mainly hepatobiliary excretion with distribution in the intestines and the urinary bladder; but without retention of the tracer in healthy organs of interests such as the lung, liver, kidneys or in the cardiovascular system. A dosimetry study in rat indicated that the whole-body effective dose was 2.2 mu Sv/MBq with bone marrow as the limiting organ. It is estimated that up to five PET-CT investigations could be performed in humans without exceeding a total dose of 10 mSv.Conclusion: [C-11]GW457427 is a promising in vivo PET-biomarker for NE with high specific binding demonstrated both in vitro and in vivo. A GMP validated production method including quality control has been developed and a microdosing toxicity study performed with no adverse signs. [C-11]GW457427 is currently being evaluated in a First-In-Man PET study.
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| 8. |
- Fernandez Prendes, Carlota, et al.
(author)
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A systematic review of experimental and clinical studies reporting on in situ laser fenestration of aortic endografts.
- 2022
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In: Journal of Vascular Surgery. - : Elsevier. - 0741-5214 .- 1097-6809. ; 75:2, s. 740-752.e1
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Journal article (peer-reviewed)abstract
- 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.
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| 9. |
- Gavali, Hamid, et al.
(author)
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Editor's Choice - Prolonged ICU Length of Stay after AAA Repair : Analysis of Time Trends and Long-term Outcome
- 2017
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In: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1078-5884 .- 1532-2165. ; 54:2, s. 157-163
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Journal article (peer-reviewed)abstract
- Objective: The aim of the study was to investigate the frequency and outcome of prolonged intensive care unit (ICU) length of stay (LOS) after abdominal aortic aneurysm (AAA) repair in the endovascular era.Methods: All patients operated on for AAA between 1999 and 2013 at Uppsala University hospital were identified. Data were retrieved from the Swedish Vascular registry, the Swedish Intensive Care registry, the National Population registry, and case records. Prolonged ICU LOS was defined as >= 48 h during the primary hospital stay. Patients surviving >= 48 h after AAA surgery were included in the analysis.Results: A total of 725 patients were identified, of whom 707 (97.5%) survived >= 48 h; 563 (79.6%) underwent intact AAA repair and 144 (20.4%) ruptured AAA repair. A total of 548 patients (77.5%) required < 48 h of intensive care, 115 (16.3%) 2-6 days and 44 (6.2%) >= 7 days. The rate of prolonged ICU LOS declined considerably over time, from 41.4% of all AAA repairs in 1999 to 7.3% in 2013 (p < .001) whereas the use of endovascular aortic repair (EVAR) increased from 6.9% in 1999 to 78.0% in 2013 (p < .001). The 30 day survival rate was 98.2% for those with < 48 h ICU stay versus 93.0% for 2-6 days versus 81.8% for >= 7 days (p < .001); the corresponding 90 day survival was 97.1% versus 86.1% versus 63.6% (p < .001) respectively. For patients surviving 90 days after repair, there was no difference in long-term survival between the groups.Conclusion: During the period of progressively increasing use of EVAR, a simultaneous significant reduction in frequency of prolonged ICU LOS occurred. Although prolonged ICU LOS was associated with a high short-term mortality, long-term outcome among those surviving the initial 90 days was less affected.
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| 10. |
- Holsti, Mari, 1963-, et al.
(author)
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Circulating Vascular Basement Membrane Fragments are Associated with the Diameter of the Abdominal Aorta and Their Expression Pattern is Altered in AAA Tissue
- 2018
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In: European Journal of Vascular and Endovascular Surgery. - : Saunders Elsevier. - 1078-5884 .- 1532-2165. ; 56:1, s. 110-118
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Journal article (peer-reviewed)abstract
- Objective: Abdominal aortic aneurysm (AAA) is characterised by enhanced proteolytic activity, and extracellular matrix (ECM) remodelling in the vascular wall. Type IV and XVIII collagen/endostatin are structural proteins in vascular basement membrane (VBM), a specialised ECM structure. Here the association between plasma levels of these collagens with the aortic diameter and expansion rate is studied, and their expression in aortic tissue characterised. Methods: This was a retrospective population based cohort study. Type IV and XVIII collagen/endostatin were analysed in plasma by ELISA assay in 615 men, divided into three groups based on the aortic diameter: 1) normal aorta <= 25 mm, 2) sub-aneurysmal aorta (SAA) 26-29 mm, and 3) AAA >= 30 mm. Follow up data were available for 159 men. The association between collagen levels and aortic diameter at baseline, and with the expansion rate at follow up were analysed in ordinal logistic regression and linear regression models, controlling for common confounding factors. Tissue expression of the collagens was analysed in normal aorta (n = 6) and AAA (n = 6) by immunofluorescence. Results: Plasma levels of type XVIII collagen/endostatin (136 ng/mL [SD 29] in individuals with a normal aorta diameter, 154 ng/ml [SD 45] in SAA, and 162 ng/ml [SD 46] in AAA; p = .001) and type IV collagen (105 ng/mL [SD 42] normal aorta, 124 ng/ml [SD 46] SAA, and 127 ng/ml [SD 47] AAA; p = .037) were associated with a larger aortic diameter. A significant association was found between the baseline levels of type XVIII/endostatin and the aortic expansion rate (p = .035), but in the multivariable model, only the initial aortic diameter remained significantly associated with expansion (p = .005). Altered expression patterns of both collagens were observed in AAA tissue. Conclusion: Plasma levels of circulating type IV and XVIII collagen/endostatin increase with AAA diameter. The expression pattern of VBM proteins is altered in the aneurysm wall.
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