Five-year sex-related outcomes of thoracic endovascular aortic repair in the Global Registry for Endovascular Aortic Treatment.

OBJECTIVE: The impact of sex on outcomes of thoracic endovascular aortic repair (TEVAR) represents an area of increased interest over the last decade, and long-term data are lacking. The aim of the present study was to investigate sex-related differences in long-term outcomes after TEVAR using real-world data from the Global Registry for Endovascular Aortic Treatment. METHODS: Data were obtained retrospectively after querying the multicenter, sponsored Global Registry for Endovascular Aortic Treatment. Patients treated with TEVAR between December 2010 and January 2021 were selected regardless of the type of thoracic aortic disease. The primary outcome was sex-specific all-cause mortality at 5 years and maximum follow-up. Secondary outcomes were sex-specific all-cause mortality at 30 days and 1 year, and aorta-related mortality, major adverse cardiac events, neurological complications, and device-related complications or reinterventions at 30 days, 1 year, 5 years, and maximum follow-up. RESULTS: A total of 805 patients were analyzed; 535 (66.5%) were males. Females were older (median, 66 years [interquartile range (IQR), 57-75 years] vs 69 years [IQR, 59-78 years], P < .001). Males had more frequently a history of coronary artery bypass grafting and renal insufficiency (8.7% vs 3.7% [P = .010] and 22.4% vs 11.6% [P < .001]). The median follow-up was 3.46 years (IQR, 1.49-4.99 years) for males and 3.18 years (IQR, 1.29-4.86 years) for females. Indications for TEVAR were mostly descending thoracic aortic aneurysms (n = 307 [38.1%]) type B aortic dissections (n = 250 [31.1%]) or others (n = 248 [30.8%]). Freedom from 5-year all-cause mortality was similar for males and females (67% [95% CI, 62.1-72.2] vs 65.9% [95% CI, 58.5-74.2]; P = .847), and there were no differences in secondary outcomes. Multivariable Cox regression showed females to have lower all-cause mortality rates; however, this difference did not reach statistical significance (hazard ratio, 0.97; 95% CI, 0.72-1.30; P = .834). Additional subgroup analyses based on the indication for TEVAR did not identify differences between both sexes for the primary and secondary outcomes except more endoleak type II in females with complicated type B aortic dissection (1.8% vs 12.1%; P = .023). CONCLUSIONS: The present analysis suggests that long-term outcomes of TEVAR performed irrespective of the type of aortic disease are similar for males and females. Further studies are needed to clarify existing controversies regarding the impact of sex on outcomes of TEVAR.

Vascular Access Challenges in Thoracic Endovascular Aortic Repair: A Literature Review.

BACKGROUND: This review aims to comprehensively summarize access challenges in thoracic endovascular aortic repair (TEVAR) by describing vascular access routes, associated risks, outcomes, and complications. METHODS: A literature search was conducted utilizing the PubMed (Medline), Scopus, and Web of Science databases. Qualitative and quantitative data from selected studies are extracted and discussed according to available standards for narrative reviews. RESULTS: In total, there were 109 eligible studies based on predefined inclusion- and exclusion criteria. There were 39 original articles or reviews and 57 case series or case reports. This article summarizes the evidence from these studies and discusses traditional retrograde access routes and techniques for TEVAR via a femoral or iliac route, with or without the use of conduits. Next, alternative antegrade access routes and techniques via a brachial, axillary, carotid, ascending aorta, transapical, transcaval, or another route are discussed. Vascular access complications are presented with specific attention to the importance of gender and alternative antegrade access routes. CONCLUSIONS: Multiple access routes and techniques are currently available to overcome access challenges associated with TEVAR, based on low grade evidence from heterogeneous studies. Future research that compares different access routes and techniques might help in the development of a tailored access protocol for specific patients with challenging TEVAR access.

Rationale and current evidence of aquatic exercise therapy in venous disease: A narrative review.

Chronic venous disorders (CVD) of the lower limbs can be treated with different strategies. Typically, conservative management is based on compression therapy, anticoagulants and venoactive drugs. Endovenous treatments remain the gold standard to treat saphenous insufficiency, with sclerotherapy and surgery maintaining a role in selected cases. In addition, several 'unconventional' approaches have been proposed to prevent CVD progression and complications, minimize symptoms and improve the quality of life and postoperative outcomes. Among these, balneotherapy and aquatic exercises are proving as valid and effective supporting treatments, as mentioned in a growing number of scientific publications. Moreover, aquatic protocols have been studied for both venous and lymphatic insufficiency. For these reasons, they were mentioned in the last CVD guidelines provided by the European Society for Vascular Surgery. The aim of this narrative review is to overview and summarize current literature evidences on the role and effectiveness of aquatic rehabilitative protocols in CVD, reviewing old and current literature. Furthermore, the physical basis of the effects of water immersion on lower limb venous and tissues modifications are also described.

Risk factors for short and long-term great saphenous vein recanalization in patients treated with endovenous radiofrequency ablation.

PURPOSE: The aim of this retrospective single-center study is to describe and analyze short-, mid-, and long-term risk factors for great saphenous vein (GSV) recanalization after endovenous radiofrequency ablation (RFA). MATERIALS AND METHODS: All consecutive patients with GSV incompetence and varicose veins underwent RFA were enrolled between 2009 and 2018. Data on demographic, pre- and postoperative color Doppler scan (CDUS) findings, perioperative complications, and follow-up were prospectively collected. Primary outcome was GSV recanalization rate at 1 week after RFA. Secondary outcomes were postoperative complication rate, as well as GSV recanalization rate at 1, 3, and 5 years after RFA. Risk factors for recanalization were also analyzed, for each follow-up assessment, identifying differences in recanalized (Rec) and non-recanalized (nRec) groups. RESULTS: During the study period, 1297 patients were treated. Among these, 1265 had at least 1 week of follow-up. Mean follow-up time was 3.0 ± 1.9 years. Recanalization rate at 1 week, 1, 3, and 5 years was 2.4%, 4.3%, 9.3%, and 17.5%, respectively. After multivariate analysis for each follow-up evaluation, CEAP classes C4 and 5, as well as preoperative GSV diameter >6 mm and history of smoking were found to be independent predictors of recanalization. Furthermore, age >61 years and postoperative complications such as pigmentation, edema, and paresthesia were found to be dependent risk factors. CONCLUSION: RFA remains a safe and durable technique to ablate incompetent GSV. Despite this, particular attention should be paid to patients with high CEAP classes to avoid short and long-term recanalization.

Differences in Mid-Term Outcomes Between Patients Undergoing Thoracic Endovascular Aortic Repair for Aneurysm or Acute Aortic Syndromes: Report From the Global Registry for Endovascular Aortic Treatment.

PURPOSE: To analyze differences in baseline characteristics, overall mortality, device-related mortality, and re-intervention rates in patients who underwent thoracic endovascular aortic repair (TEVAR) for descending thoracic aortic aneurysm (DTAA) with atherosclerotic/degenerative cause or acute aortic syndrome (AAS), using the Global Registry For Endovascular Aortic Treatment (GREAT). MATERIALS AND METHODS: Patients submitted to TEVAR for AAS or DTAA, included in GREAT, were eligible for this analysis. Primary outcome was 30-day all-cause mortality rate. Secondary outcomes were 30-day aorta-related mortality and re-intervention rate, 1-year and 3-year all-cause mortality, aorta-related mortality and re-intervention rate. RESULTS: Five-hundred and seventy-five patients were analyzed (305 DTAA and 270 AAS). Thirty-day mortality rate was 1.3% and 1.8% for DTAA and AAS, respectively (p=0.741). One-year and 3-year mortality rates were 6.2% versus 9.3 and 17.3% versus 15.9% for DTAA and AAS, respectively (p=0.209 and p=0.655, respectively). Aorta-related mortality rates at 30 days, 1 year and 3 years were 1.3%, 1.3%, and 2.6% for DTAA, 1.8%, 4.2%, and 4.2% for AAS (p=ns). Re-intervention rates at 30 days, 1 year, and 3 years were 1.3%, 4.3%, and 7.5% for DTAA, 3.3%, 8.1%, and 10.7% for AAS (p=ns). Furthermore, a specific analysis with similar outcomes was performed dividing follow-up in 3 periods (1-30 days, 31-365 days, 366-1096 days) and describing mutual differences between 2 groups and temporal trends in each group. CONCLUSION: Patients who underwent TEVAR for DTAA or AAS experienced different mortality and re-intervention rates among years during mid-term follow-up. Although all-cause related deaths within 30 days were TEVAR-related, aorta-related deaths were more common for AAS patients within 1 year. A greater re-intervention rate was described for AAS patients, although only 1 year after TEVAR.

Early and Midterm Results after Endovascular Repair of Non-infected Saccular Lesions of the Infrarenal Aorta.

OBJECTIVE: The aim was to report short and midterm outcomes of a cohort of consecutive patients treated by endovascular aortic repair (EVAR) for saccular lesion of the abdominal aorta (sl-AA). METHODS: This was a multicentre, retrospective, financially unsupported physician initiated, observational cohort study that involved tertiary referral from Italian hospitals. For this study, between January 2010 and December 2020, only those patients treated by EVAR for non-infected sl-AA, namely blister/ulcer like projection and/or penetrating aortic ulcer, were analysed. Primary outcomes of interest were overall survival and freedom from aorta related mortality (ARM). RESULTS: The final cohort included 120 of 3 982 eligible aortic lesions. There were 103 (85.8%) males and 17 (14.2%) females. The median age was 76 years (interquartile range [IQR] 69, 80). Rupture on admission was observed in 10 (8.3%) cases. Early (≤ 30 days) death occurred in two (1.7%) patients. There were five (4.2%) complications requiring surgical re-intervention (iliac limb occlusion n = 4; groin haematoma, n = 1). The median duration of follow up was 20 months (IQR 4, 59.5): the estimated overall survival was 85.5% (standard error [SE] 0.035; 95% confidence interval [CI] 77.3 - 91.1) at 12 months, 78.7% (SE 0.044; 95% CI 69.0 - 86.0) at 36 months, and 74% (SE 0.050; 95% CI 63.2 - 82.5) at 60 months. Only one (0.8%) patient required aortic re-intervention during follow up because of a late endograft infection. The estimated freedom from ARM was 96% (SE 0.050; 95% CI 90.3 - 98.2) at 36 and 60 months. Cox's regression analysis identified that death was associated with age > 70 years (hazard ratio [HR] 1.10; 95% CI 1.04 - 1.17, p = .001), and coronary artery disease (HR 1.14; 95% CI 1.04 - 1.26, p = .006). CONCLUSION: EVAR for sl-AA proved to be safe and effective. The mortality rate was low for a group of patients known to be at high risk from open repair, and EVAR remained stable with no ARM during midterm follow up, and an acceptably low 0.8% endograft related re-intervention rate.

Is there a vascular side of the story? Vascular consequences during COVID-19 outbreak in Lombardy, Italy.

BACKGROUND: Lombardy, in the northern Italy, was one of the most affected region in the world by novel coronavirus COVID-19 outbreak. Due to the dramatic amount of confirmed positive cases and deaths, all clinical and surgical hospital departments changed their daily activities to face emergent pandemic situations. In particular, vascular surgery units reorganized their role and priorities for both elective and urgent patients requiring open or endovascular interventions. MATERIAL & METHODS: This brief review summarizes organization of vascular Lombardy centers network adopted during pandemic period and clinical evidences published so far by regional referral and nonreferral hospitals in terms of vascular surgery and medicine implications in COVID-19 positive or negative patients managements. RESULTS: Different patterns of disease were described during phase 1 COVID-19 outbreak in Lombardy region, with major attention in pheriperal artery disease and venous thrombosis. CONCLUSION: COVID-19 infection seems to be not only a pulmonary but also a vascular (arterial and venous) disease. Further study are necessary to described mid and long-term outcomes in COVID-19 vascular patients population.

Gender Related Access Complications After TEVAR: Analysis from the Retrospective Multicentre Cohort GORE® GREAT Registry Study.

OBJECTIVE: The Global Registry for Endovascular Aortic Treatment (GREAT), a retrospective sponsored registry, was queried to determine the incidence and identify potential predictors of access related complications after TEVAR. METHODS: This is a multicentre, observational cohort study. For the current study, all patients were treated only with the Conformable GORE® TAG® Thoracic Endoprosthesis and GORE® TAG® Thoracic Endoprosthesis devices for any kind of thoracic aortic disease. All serious adverse events within 30 days of the procedure were documented by sites. The following were considered access related complications: surgical site infection, pseudoaneurysm, avulsion, dissection, arterial bleeding, access vessel thrombosis/occlusion, seroma, and lymphocoele. RESULTS: A total of 887 patients was analysed: most of the cases had an operative indication for TEVAR of degenerative atherosclerotic aneurysm (n = 414, 46.7%) and type B dissection (n = 270, 30.4% either complicated or uncomplicated). Two hundred and ninety-five patients (33.3%) were female. The overall access related complication rate was 2.8% (n = 25): 4.7% (n = 14) in women and 1.8% (n = 11) in men (p = .013). After adjustment for age, urgency, device diameter, introducer sheath (≥24Fr vs. ≤ 24Fr), access vessel diameters, and access method, female gender was significantly associated with the risk of access complications (OR 2.85; p = .038). Brachial artery for access was also found to be an independent predictor of access related complications (OR 8.32; p < .001). CONCLUSION: This analysis suggests that women may have a higher access related complication rate after TEVAR, irrespective of the clinical setting, type of aortic disease, and device sizing.

Thoracic endovascular stent graft repair for ascending aortic diseases.

OBJECTIVES: We describe the preliminary results of thoracic endovascular aortic repair (TEVAR) in a group of patients with ascending aortic disease from the Global Registry for Endovascular Aortic Treatment (GREAT). METHODS: We identified TEVAR performed for diseases truly originating from the ascending aorta. Between July 2011 and May 2015, 5014 patients were enrolled; six (0.12%) were identified and included in the analysis. One further patient was withdrawn from the study due to lack of a signed consent form. Patients having a "zone 0" proximal landing zone reported for their TEVAR without the presence of an ascending aortic disease were not included. Reinterventions of previous open and endovascular repair were also excluded. RESULTS: Three males and three females were treated. Mean age was 69 years ± 10 years (range, 58-83 years). Indication for TEVAR was atherosclerotic aneurysm (n = 4; ruptured, n = 1), complicated type A dissection (n = 1, rupture), and pseudoaneurysm (n = 1). Mean maximum aortic lesion diameter was 60 mm 14 (range, 39-77 mm). Urgent intervention was performed in three (50%) cases. Primary clinical success was 100%. There was no TEVAR-related in-hospital mortality. Open conversion was never required. Complication such as cerebrovascular accidents, valve impairment, or myocardial infarction did not occur. All patients were discharged home alive. No patient was lost at a median follow-up of 26 months (range, 16-72 months). During the follow-up, no patient died and ongoing primary clinical success was maintained in all patients. Reintervention was never required; endoleaks, migrations, fractures, or ruptures were not observed. CONCLUSIONS: Preliminary "real-world" experience of ascending TEVAR shows satisfactory outcomes at short-term follow-up. Although concerns remain for "off-label" use of standard devices, TEVAR-related complications were not observed. Longer follow-up data are expected to confirm durability of these results.

Pre-operative Color Doppler Ultrasonography Predicts Endovenous Heat Induced Thrombosis after Endovenous Radiofrequency Ablation.

OBJECTIVES: The aim was to identify pre-operative color Doppler ultrasound (CDUS) variables predictive of post-operative endovenous heat induced thrombosis (EHIT) after radiofrequency ablation (RFA) of the saphenous veins. DESIGN: This was a single centre, observational study with retrospective analysis of consecutive patients treated from December 2010 to February 2017. MATERIALS AND METHODS: Pre-operatively, the diameter of the sapheno-femoral junction (dSFJ), distance between superficial epigastric vein and SFJ (dSEV-SFJ) [corrected], maximum great saphenous vein (GSV) diameter (mdGSV), diameter of the saphenous-popliteal junction (dSPJ), and mean small saphenous vein (SSV) diameter (adSSV) were measured. All patients received low molecular weight heparin (LWMH) at a prophylactic dose for a week. Post-operatively, CDUS was performed after 72 h, 1 week, and 3 months. RESULTS: Venous interventions on 512 patients were performed: 449 (87.7%) underwent RFA of the GSV (Group 1), and 63 (12.3%) of the SSV (Group 2). At Day 3 post-operatively, CDUS documented 100% complete closure of the treated saphenous vein segment. Overall, 40 (7.8%) cases of post-operative EHIT were identified: 29 in Group 1, and 11 in Group 2 (6.4% vs. 17.5%, p = .005). Deep venous thrombosis or pulmonary embolism did not occur in either group. At the 1 month follow up, all cases of EHIT regressed. In Group 1, on multivariate analysis, dSEV-SFJ [corrected] (OR, 1.13, p = .036; 95% CI 1.01-1.27) was the only statistically significant predictor for EHIT. A dSEV-SFJ [corrected] distance of 4.5 mm yielded an 84% of sensitivity for EHIT prediction with a 72.4% positive predictive value. In Group 2, univariate analysis did not identify independent risk factors for EHIT occurrence. CONCLUSIONS: EHIT was higher than previously reported. The dSEV-SFJ [corrected] was the most significant predictor for EHIT in the GSV group. A greater distance between the tip of the radiofrequency catheter and the SFJ may decrease the risk of developing this complication.

Surgical Treatment of Synchronous Type B Acute Aortic Dissection and Abdominal Aortic Aneurysm.

BACKGROUND: We report the results of the operative treatment of synchronous type B acute aortic dissection (TBAAD) and infrarenal abdominal aortic aneurysm (AAA). METHODS: It is an observational, descriptive multicenter case series. Inclusion criterion was patients with diagnosis of TBAAD and AAA detected synchronously for the first time at clinical onset of dissection. Follow-up imaging protocol included triple-phase spiral/computed tomography angiography performed at 1, 6, and 12 months after thoracic endovascular aortic repair (TEVAR), and annually thereafter. Major end points were perioperative mortality and long-term survival, freedom from aortic events, and freedom from reintervention. RESULTS: We identified and treated 15 cases. All TBAADs were treated by TEVAR in the acute phase: infrarenal aortic repair was performed with stent graft (SG) in 10 (66.7%) patients, with open repair in 5 (33.3%). Overall, staged repair was used in 11 (73.3%) patients. Mean descending aortic endovascular length coverage was 21 cm ± 7 (range, 10-35; interquartile range [IQR], 150-265). Overall, early perioperative mortality occurred in 1 (6.7%) patient. Median radiologic follow-up was 48 months (range, 6-120; IQR, 36-67). During the follow-up, TEVAR-related mortality was not observed. Aortic remodeling after TEVAR was obtained in 12 (85.7%) patients; abdominal sac shrinkage after SG was obtained in 8 (80.0%) patients. Freedom from aortic event rate was 79% ± 10 (95% confidence interval [CI]: 53.1-92.6) at 1 year and 64% ± 13 (95% CI: 38.1-83.5) at 5 year. Freedom from reintervention rate at 1 and 5 year was 85% ± 10 (95% CI: 57.8-95.7). CONCLUSIONS: In our experience, the association of TBAAD and AAA was a rare finding. Because of the lack of available evidence to opt for a single intervention or a staged approach, selective approach with TEVAR and endovascular/open conventional treatment of the abdominal aorta yielded satisfactory results at midterm follow-up.

Activities at Thoracic Aortic Research Center, IRCCS Policlinico San Donato.

The Thoracic Aortic Research Center (TARC) of the IRCCS Policlinico San Donato (PSD) aims to promote research on thoracic aortic diseases, to disclose the scientific knowledge and clinical experience and to develop new scientific paths within the Hospital and the aortic community, in collaboration with other national and international centres. Thoracic Aortic Research Center collaborates with many centres in both Europe (e.g. University of Utrecht, the Netherlands) and the USA (e.g. University of Michigan). This has led to multiple highly regarded publications in respected cardiovascular journals and has led to several PhD programmes resulting in doctorate degrees. Within Italy, in association with the Bioengineering School of the University of Pavia, TARC has founded the "BETA-lab" (Biomechanics for Endovascular Treatment of the Aorta laboratory), where MDs, Bioengineers, and PhD fellows conduct experimental studies using in vitro/ex vivo models of the physiologic aorta and aortic diseases. Furthermore, a database (iCardiocloud) where the medical imaging of cardiovascular patients from the PSD is structured, for in silico analysis utilizing computational fluid dynamics, and in vitro studies using also 3D printed aortic models. With the role of principal investigator or co-investigator, TARC at PSD has been participating in other several projects, including the International Registry of Acute Aortic Dissection, the International Aortic Arch Surgery Study Group, the European Registry of Endovascular Aortic Repair Complications, the ADSORB and ASSIST trials, and the GREAT registry. International collaborations have included also studies on predictors of aortic growth after dissection with the Yale University and University of Virginia, and on aortic biomarkers with the University of Tokyo.

Incidence, predictors, and prognostic impact of in-hospital serious adverse events in patients ≥75 years of age undergoing elective endovascular aneurysm repair.

BACKGROUND: This study sought to identify the factors associated with the occurrence of in-hospital serious adverse events after elective endovascular aortic repair (EVAR) in older patients within the Global Registry for Endovascular Aortic Treatment. METHODS: Consecutive patients ages ≥75 years who received GORE EXCLUDER AAA Endoprosthesis (W.L. Gore & Associates, Inc, Flagstaff, AZ) for elective EVAR. Based on the age at index elective EVAR, patients were categorized into 3 groups for subsequent analyses: those ages 75 to 79, 80 to 84, and ≥85 years. The primary end points for this study were the incidence of serious adverse events and all-cause mortality. In-hospital complications were defined according to the International Organization for Standardization 14155 standard (https://www.iso.org/standard/71690.html) and considered serious adverse events if they led to any of the following: (1) a life-threatening illness or injury, (2) a permanent impairment of a body structure or a body function, (3) in-patient or prolonged hospitalization, or (4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function. RESULTS: Overall, 1,333 older patients (ages 75-79: n = 601; 80-84: n = 474; and ≥85: n = 258) underwent elective EVAR in the Global Registry for Endovascular Aortic Treatment data set and were included in the present analysis. In total, 12 patients (0.9%) died perioperatively, and 103 patients (7.7%) experienced ≥1 in-hospital serious adverse event, with 18 patients (1.3%) experiencing >1 in-hospital complications. No significant differences were seen between the age groups in the rates of in-hospital serious adverse events (7.3% vs 8.2% vs 7.8%; P = .86). In logistic regression analysis, a history of chronic obstructive pulmonary disease (odds ratio = 2.014; 95% confidence interval, 1.215-3.340; P = .006) and prior requirement for dialysis (odds ratio = 4.655; 95% confidence interval, 1.087-19.928; P = .038) resulted as predictors for occurrence of in-hospital serious adverse events. In the whole cohort, the 5-year survival was 63% for patients who did not experience any in-hospital serious adverse events compared with 51% for those who experienced any complications (P = .003). Using multivariable Cox proportional hazards models, it was found that the occurrence of in-hospital serious adverse events (hazard ratio = 6.2; 95% confidence interval, 1.8-21.317; P = .003) and being underweight (hazard ratio = 7.0; 95% confidence interval, 1.371-35.783; P = .019) were the only independent predictors of death in ≤30 days from the initial intervention. Although age did not independently affect the risk for all-cause mortality in ≤180 days after the initial intervention, increasing age was associated with a higher risk for long-term death (ie, ≥181 days from index elective EVAR) in the multivariable analysis (ages 75-79: hazard ratio = 0.379; 95% confidence interval, 0.281-0.512; P < .001; and 80-84: hazard ratio = 0.562; 95% confidence interval, 0.419-0.754; P < .001). CONCLUSION: After elective EVAR in older patients (ie, ≥75 years), the occurrence of in-hospital serious adverse events appears to increase the risk of death, particularly in ≤180 days after the initial elective EVAR intervention, and might be related to patient baseline characteristics, including history of pulmonary and renal disease.