Anatomical suitability for branched endovascular aortic arch repair and balloon-expandable bridging stent grafts in a cohort of patients previously treated with a hybrid approach.

OBJECTIVE: We assessed the suitability of two triple branch arch devices (aBranch) (Terumo aortic and Cook Medical) and a balloon-expandable covered stent (VBX, W. L. Gore & Associates, Johnson & Johnson) to incorporate the brachiocephalic trunk (BCT) in a cohort previously treated with hybrid thoracic endovascular repair (TEVAR). METHODS: This is a single-center, retrospective, all-comers, preclinical suitability study. We conducted an analysis of preoperative computed tomography scans in surgical patients between 1999 and 2022 in a single vascular surgery unit. The primary outcome was the aortic suitability of aBranch devices and VBX as mating stent for BCT in previous hybrid TEVAR. Hybrid repair of the aortic arch included TEVAR, fenestrated or branched TEVAR associated with any surgical debranching of the supra-aortic trunks and chimney TEVAR with proximal landing in zones 0 to 2. Secondary outcomes included (i) suitability assessment when excluding minor instruction for use (IFU) criteria, (ii) a comparison of suitable and nonsuitable patients, (iii) risk factors analysis for nonsuitability, and (iv) a description of the exclusion causes. RESULTS: During the study period, 120 patients were treated. Among elective patients (n = 73), the suitability of any aBranch was 82.2% (60/73) and VBX was suitable in 64.4% of BCTs (47/73). The aBranch suitable patients had a significantly longer sinotubular-BCT length (P = .017) and smaller distal ascending aorta (P = .043) as compared with nonsuitable ones. The suitability of Terumo Aortic and Cook Medical devices was 52.1% (38/73) and 46.6% (34/73), respectively. When minor IFU criteria were ignored, suitability increased to 82.2% (60/73) and 63.0% (46/73), respectively. Left common carotid artery diameter and sinotubular-BCT length were significant nonsuitability risk factors for Terumo Aortic aBranch in multivariable analysis. No associations were found for Cook Medical device. The outcomes were tested in the entire cohort demonstrating a global suitability of 82.9%, increasing to 86.3% when ignoring minor IFUs. VBX was anatomically suitable to use in BCT in 73.2% of patient BCTs. CONCLUSIONS: aBranch devices are anatomically suitable in a vast majority of patients (86%) undergoing hybrid TEVAR. The innominate artery seems eligible for incorporation with VBX in almost two-thirds of patients. This mating stent may help to overcome some minor IFU restrictions.

Comparison of bridging stent grafts in branched endovascular aortic repair.

BACKGROUND: Endovascular treatment of thoracoabdominal aortic aneurysms has become common, with satisfactory results. Nevertheless, long-term durability remains an issue mainly because of target visceral vessel (TVV) instability. Currently, no covered stent has been approved as a bridging stent graft (BSG), demanding continuous research on this topic. METHODS: This was a multicenter observational retrospective cohort study comparing the midterm results of the Bard Covera Plus and Gore VBX as BSGs during branched endovascular aneurysm repair. The primary outcome was the comparison of the target vessel instability between the two groups. Primary patency, freedom from branch-related type I and III endoleaks and reintervention, and technical and clinical success were considered secondary outcomes. Logistic regression analysis was used to assess the association between selected baseline factors and TVV instability. TVV instability during follow-up was then evaluated using the Kaplan-Meier cumulative function. RESULTS: Three hundred forty-five TVVs in 106 patients were considered suitable for the analysis. Two hundred twenty vessels were stented with the Covera stent graft (64%) and 125 with VBX (36%). Two hundred ninety-nine TVVs received a single BSG, 45 two BSGs, and only 1 three BSGs. Bare metal stent relining was required in 36% of TVVs, mostly in the Covera group (89 [41%] vs 36 [29%]) (P = .030). The primary technical success rate was 96% (331/345), and the assisted primary technical success rate was 99% (342/345). The TVV instability rate within 30 days was 2% (one Covera and five VBX; P = .015). Three BSG occlusions (one Covera and two VBX) and three type Ic endoleaks (three VBX) were detected. The median follow-up was 13.9 months (range, 5.8-25.5 months). Sixteen TVV instabilities were detected during the follow-up. Twelve BSG occlusions (six Covera and six VBX), three type Ic endoleaks (one Covera and two VBX), and one type IIIc endoleak (VBX). The overall target vessel instability rate was 5% (16/342). TVV instability was associated with the use of Gore VBX in the univariable logistic regression (odds ratio, 3.0; 95% confidence interval, 1.1-8.0; P = .027). Aneurysm rupture and aneurysm diameter were also associated with TVV instability in the univariable analysis (P = .002 and P = .008, respectively). The only factor predisposing to TVV instability in the multivariable logistic regression analysis was the use of Gore VBX as a BSG (odds ratio, 2.9; 95% confidence interval, 1.0-8.0; P = .043). Kaplan-Meier analysis showed a significantly higher risk of TVV instability in the VBX group (P < .001). CONCLUSIONS: Overall midterm outcomes in this cohort were satisfactory. Patency rates were similar between the two stents. Nevertheless, VBX seems to be associated with worse TVV instability. These results may be correlated with a higher incidence of type Ic endoleaks, which require an extensive learning curve for correct stent selection and deployment.

Systematic review and meta-analysis of cerebrospinal fluid drain-related mortality and morbidity after fenestrated-branched endovascular aortic repair.

OBJECTIVE: This study aimed to investigate the incidence of cerebrospinal fluid drainage (CSFD)-related complications specifically in patients who underwent fenestrated and branched endovascular aortic repair (F/B-EVAR). This objective was chosen considering the limitations and uncertainties surrounding its efficacy in preventing spinal cord injury. METHODS: A systematic review following Cochrane Handbook and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines was conducted (PROSPERO; #CRD42022359223). Literature searches of MEDLINE, Embase, and Scopus were performed until May 1, 2023, focusing on studies published after January 1, 2000. The inclusion criteria encompassed studies reporting on F/B-EVAR, CSFD, and drain-related complications. Data extraction and quality assessment using the Newcastle-Ottawa Scale were performed by multiple reviewers to ensure accuracy and reliability. A proportion meta-analysis was conducted to calculate the pooled rate and 95% confidence interval (CI). The primary and secondary outcomes were CSFD-related mortality and morbidity, respectively. RESULTS: Six retrospective, observational, single-center studies were included, totaling 1079 patients and 730 CSFD placements (all prophylactic except for one). The Newcastle-Ottawa Scale showed a high to moderate risk of bias. The analysis revealed a CSFD-related mortality rate of 1.4% (95% CI: 0.0-4.8; I2 = 67.7%) and an overall morbidity rate of 25.6% (95% CI: 13.6-39.7; I2 = 83.2%). The overall major, moderate, and minor estimated complication rates were 6.1% (95% CI: 4.1-8.5; I2 = 0%), 4.6% (95% CI: 2.4-7.3; I2 = 33.5%), and 26.4% (95% CI: 16.5-37.7; I2 = 84.9%), respectively. Severe complications included intracranial hemorrhage (2.8%), spinal hematoma (1.4%), subarachnoid hemorrhage (1.4%), and CSFD-related neurological deficits (1.1%). A pooled estimate of 11.4% for nonfunctioning drainage was found. CONCLUSIONS: F/B-EVAR patients showed a notable incidence of CSFD-related death and substantial morbidity. This study highlights the limitations of the available data, the high prevalence of complications associated with CSFD, and the need for further research to better understand the risks and benefits of CSFD in F/B-EVAR. This calls for careful consideration regarding the routine use of prophylactic drainage due to the accumulating evidence of the risks associated with CSFD without proven benefit in this specific context.

Comparison of bare and nonbare stent grafts during thoracic endovascular aneurysm repair of the aortic arch.

OBJECTIVE: We compared the outcomes of patients treated with nonbare stents (NBS) and proximal bare stents (PBS) endografts with a proximal landing zone in the aortic arch during thoracic endovascular aortic repair (TEVAR). METHODS: We conducted a retrospective cohort, observational, multicenter study that included 361 consecutive TEVAR procedures undertaken between November 2005 and December 2021. TEVAR patients with both BS and NBS Relay stent graft configurations with proximal landing in zones 1, 2, or 3 were enrolled. Preoperative anamnestic and morphological data, clinical outcomes, and aortic modifications 30 days after surgery and at the latest follow-up available were collected. The primary outcome was freedom from proximal endoleak (type IA) comparing the two configurations. Total and detailed endoleak rates, clinical and technical success, intraoperative additional maneuvers, major adverse events, and reinterventions were secondary outcomes. RESULTS: The median follow-up was 4.9 (interquartile range, 2.0-8.1) years. No statistically significant difference between NBS and PBS patients concerning 30-day major adverse events, retrograde aortic dissection, disabling stroke, or late type IA endoleak (10.8% vs 7.8%; P = .597). Aneurysmal disease (P = .026), PLZ diameter of >34 mm (P = .026), aortic tortuosity index of >1.4 (P = .008), type III aortic arch (P = .068), and PLZ thrombus (P = .014) identified as risk factors by univariate Cox regression analysis. PLZ thrombus was the only type IA endoleak risk factor at multivariate Cox regression (P = .016). CONCLUSIONS: We found no statistically significant difference in freedom from type IA endoleak, retrograde dissection, or disabling stroke observed between the NBS and the BS configuration of the Relay endograft. Proximal landing zone thrombotic apposition was a prominent risk factor for type IA endoleak after TEVAR.

Type III Endoleak Incidence and Outcomes in Endovascular Aortic Repair: Comparison of Anatomical and Proximal Fixation Devices.

PURPOSE: To evaluate the influence of endograft fixation type on the incidence, treatment, and outcomes of type III endoleaks (TIIIELs). MATERIALS AND METHODS: Abdominal aortic aneurysms (AAAs) treated with bifurcated endografts between 1994 and 2020 were prospectively collected and reviewed. The endograft included were classified as "Anatomical Fixation" (AF) (Powerlink [Endologix] and AFX [Endologix]) or "Proximal Fixation" (PF). The primary outcome was the incidence of TIIIEL over time, stratified by fixation type. Secondary outcomes included between-group comparisons of baseline characteristics, intraoperative details during TIIIEL correction, and survival analysis after TIIIEL diagnosis. RESULTS: A total of 2065 endovascular aneurysm repairs were performed: 872 (42.2%) with AF and 1193 (57.8%) with PF devices. The estimated incidence of TIIIEL at 1, 5, and 10 years was 0.4%, 4.2%, and 7.3%, and 0.5%, 3.2%, and 4.6% for AF and PF, respectively (p=0.157), and fixation type was not associated with TIIIEL development in the competing risk regression model (p=0.101). The cumulative overall survival rate in patients diagnosed with TIIIEL did not differ significantly between the groups (p=0.077). The rate of recurrent TIIIELs was significantly lower in the AF group (7.1% vs 22.7%; p=0.044); however, no significant difference was found in secondary reintervention between the two groups (11.9% vs 27.3%, p=0.074). Patients with angulated and calcified aortic neck (SHR 3.4, 95% CI 1.2-9.6, p=0.022) and larger aneurysms (SHR 1.2; 95% CI 1.1-1.3; p<0.001) had a higher risk of TIIIEL. Likewise, the use of three or more endograft components increased the risk of TIIIEL by 3.1 times (SHR 3.1; 95% CI 1.7-5.4; p<0.001). CONCLUSIONS: The occurrence of TIIIELs was not affected by the type of endograft fixation. For larger abdominal aortic aneurysms (AAAs) and aneurysms with angulated and calcified aortic necks, there is a higher likelihood of developing TIIIELs during follow-up, regardless of the endograft type used. CLINICAL IMPACT: The type of fixation does not influence the incidence of TIII ELs. EVAR in larger AAAs and aneurysms with angulated and calcified aortic necks have a higher risk of developing TIII EL. Moreover, the risk of TIII EL is considerably increased by the use of three or more modular components.

Intravascular Ultrasound in the Detection of Bridging Stent Graft Instability During Fenestrated and Branched Endovascular Aneurysm Repair Procedures: A Multicentre Study on 274 Target Vessels.

OBJECTIVE: The use of intravascular ultrasound (IVUS) reduces contrast medium use and radiation exposure during conventional endovascular aneurysm repair (EVAR). The aim of this study was to evaluate the safety and efficacy of IVUS in detecting bridging stent graft (bSG) instability during fenestrated and branched EVAR (F/B-EVAR). METHODS: This was a prospective observational multicentre study. The following outcomes were evaluated: (1) technical success of the IVUS in each bSG, (2) IVUS findings compared with intra-operative angiography, (3) incidence of post-operative computed tomography angiography (CTA) findings not detected with IVUS, and (4) absence of IVUS related adverse events. Target visceral vessel (TVV) instability was defined as any branch or fenestration issues requiring an additional manoeuvre or re-intervention. Any IVUS assessment that detected stenosis, kinking, or any geometric TVV issue was considered to be branch instability. All procedures were performed in ad hoc hybrid rooms. RESULTS: Eighty patients (69% males; median age 72 years; interquartile range 59, 77 years) from four aortic centres treated with F/B-EVAR between January 2019 and September 2021 were included: 70 BEVAR (21 off the shelf; 49 custom made), eight FEVAR (custom made), and two F/B-EVAR (custom made), for a total of 300 potential TVVs. Two TVVs (0.7%) were left unstented and excluded from the analysis. The TVVs could not be accessed with the IVUS catheter in seven cases (2.3%). Furthermore, 17 (5.7%) TVVs could not be examined due to a malfunction of the IVUS catheter. The technical success of the IVUS assessment was 91.9% (274/298), with no IVUS related adverse events. Seven TVVs (2.5%) showed signs of bSG instability by means of IVUS, leading to immediate revisions. The first post-operative CTA at least 30 days after the index procedure was available in 268 of the 274 TVVs originally assessed by IVUS. In seven of the 268 TVVs (2.6%) a re-intervention became necessary due to bSG instability. CONCLUSION: This study suggests that IVUS is a safe and potentially valuable adjunctive imaging technology for intra-operative detection of TVV instability. Further long term investigations on larger cohorts are required to validate these promising results and to compare IVUS with alternative technologies in terms of efficiency, radiation exposure, procedure time, and costs.

Editor's Choice - Outcomes of Off the Shelf Outer Branched Versus Inner Branched Endografts in the Treatment of Thoraco-Abdominal Aortic Aneurysm in the B.R.I.O. (BRanched Inner - Outer) Study Group.

OBJECTIVE: This study aimed to compare two commercially available off the shelf branched endografts for thoraco-abdominal aortic aneurysm (TAAA) repair, namely the E-nside (Artivion) and Zenith t-Branch (Cook Medical) devices. METHODS: This multicentre retrospective study (2020 - 2023) included patients treated by branched endovascular aortic repair (BEVAR) for TAAA using the inner branched E-nside or the outer branched t-Branch. Endpoints were 30 day technical success and major adverse events (MAEs) as well as one year freedom from target vessel instability and main endograft instability. RESULTS: The study included 163 patients: 79 (307 target vessels) treated with E-nside and 84 (325 target vessels) with t-branch. Aneurysm extent was I - III in 91 patients (55.8%; 47% of E-nside and 66% of t-Branch) and IV in 72 patients (44.2%; 53% of E-nside and 34% of t-Branch) (p = .011). An adjunctive proximal thoracic endograft was used in 43% of E-nside vs. 69% of t-Branch (p < .001), with less frequent thoracic endografting (14% vs. 76%; p < .001) and shorter length of coverage (p = .024) in extent IV TAAA treated by E-nside. E-nside cases had shorter renal artery bridging lengths (66 ± 17 mm vs. 76 ± 20 mm; p < .010) and less frequent use of a distal bifurcated endograft (53% vs. 80%; p < .001). Comparing 30 day results, the mortality rate was 1% vs. 2% (p = .62), any MAE occurred in 18% vs. 21% (p = .55), the stroke rate was 3% vs. 0% (p = .23), and the elective spinal cord ischaemia rate was 5% vs. 8% (p = .40) for E-nside and t-Branch, respectively. At one year, freedom from target vessel instability was 96 ± 3% for E-nside and 95 ± 3% for t-Branch (p = .58), and freedom from endograft instability was 98 ± 2% vs. 97 ± 3% (p = .46), respectively. CONCLUSION: Both off the shelf devices provided excellent early and one year results. The E-nside may require shorter thoracic aortic coverage and bridging length for the renal arteries, and less frequent implantation of a concomitant proximal thoracic or distal abdominal bifurcated endograft. However, these aspects did not determine significant differences in clinical outcomes.

Clinical and radiologic treatment outcomes of implant presence tirggered-MRONJ: Systematic review of literature.

BACKGROUND: The present systematic review evaluated clinical and radiographic features and treatment outcomes of peri-implantitis-induced medication-related osteonecrosis of the jaws (Pi-MRONJ). MATERIALS AND METHODS: Literature search was performed in PubMed/MEDLINE, Cochrane CENTRAL, Web of Science, and Scopus databases. Studies reporting Pi-MRONJ were included. No time restrictions were applied. RESULTS: In total, 571 articles were retrieved, and 24 articles were included in the final review. Study population consisted of 111 patients (70% pharmacologically treated for osteoporosis and 30% for oncologic disease). Pi-MRONJ was characterized by pain, bone exposure and suppuration, and involved a single implant in 55 cases, two implants in 37 cases, three implants in 10 cases, and more than four implants in nine cases. Most of the lesions were assigned Stage II and III. MRONJ developed on average 46.5 ± 33.2 months following implant placement. Sixty-one lesions were surgically treated with implant removal and debridement of the surrounding necrotic bone. Complete wound healing was observed in 85% of cases. CONCLUSIONS: The presence of dental implants in patients treated with antiresorptive drugs should be considered as a potential risk factor for MRONJ onset. In cases of periimplantitis with delayed wound healing following nonsurgical therapy, the clinician should rule out the presence of Pi-MRONJ.

Early periodontal wound healing after chlorhexidine rinsing: a randomized clinical trial.

OBJECTIVES: This single-center randomized, parallel design, clinical trial with a 2-week follow-up involved patients affected by periodontitis undergoing periodontal surgery. The aim was to evaluate periodontal surgical wound healing with the use of chlorhexidine-based mouth rinses versus an untreated control group. MATERIALS AND METHODS: Periodontal surgery was performed following a standardized protocol. Patients were randomly prescribed i) chlorhexidine (CHX) + anti-discoloration system (ADS) + hyaluronic acid (HA), ii) CHX + ADS or iii) no treatment (control group). Plaque score, gingival inflammation, and Early Healing Index (EHI), assessing the degree of wound closure and the presence of fibrin and necrosis, were evaluated at 3, 7 and 14 days after surgery. RESULTS: In total, 33 patients were enrolled. Patients were comparable at baseline for all measured clinical parameters. At 3-days wound healing was significantly improved in all patients treated with CHX + ADS-based mouth rinses with a lower EHI score at the interdental papillae compared with control group (p < 0.01). CHX + ADS + HA group presented improved healing across all time points in terms of EHI, plaque containment, and gingival inflammation when compared to control group (p < 0.01). CONCLUSIONS: The usage of CHX-ADS following periodontal surgery improved early wound healing, reduced plaque accumulation and gingival inflammation. During the early post-operative period the adjunct of HA further improved soft tissue closure. CLINICAL RELEVANCE: This study aims at evaluating the response of gingival tissues to mouth rinsing with chlorhexidine and anti-discoloration system (CHX + ADS) or CHX + ADS + hyaluronic acid (CHX + ADS + HA) versus no rinse in terms of healing of the periodontal surgical wound. CHX + ADS mouth rinses enhanced early soft tissue closure after periodontal surgery and contributed to the reduction in plaque accumulation and gingival inflammation. The adjunct of HA may be beneficial especially in the early post-operative period. CHX + ADS administration following periodontal surgery may improve soft tissue healing in the first two post-operative weeks.

Transcranial Doppler detects micro emboli in patients with asymptomatic carotid stenoses undergoing endarterectomy.

OBJECTIVE: The objective of this study was to assess the primary endpoint defined as the detection of micro-embolic signals (MES) by the use of transcranial Doppler (TCD) in patients with asymptomatic carotid stenosis (≥70%) scheduled for carotid endarterectomy. The secondary endpoint consisted of testing the association of MES with stenosis severity, histopathological, and ultrasound characteristics. METHODS: This was a single-center, single-arm, prospective, observational trial. Computed tomography angiography and ultrasound assessment (Geroulakos classification) were mandatory as well as being under best medical therapy. MES number and characteristics were investigated in Holter mode TCD-X device with a standard 1.5 MHz probe. The time points of evaluation were: 24 hours preoperative, 24 hours postoperative, and 30 days postoperative. The histopathological analysis was performed according to the modified American Heart Association classification. One-way analysis of variance tested MES differences over time. Univariable and multivariable logistic regression tested variables potentially associated with MES. RESULTS: A total of 120 patients demonstrated a significant reduction of the mean number of MES (3.35 ± 10.04 and 0.82 ± 2.39; pre- and post-carotid endarterectomy, respectively), becoming undetectable at 30 days (P = .001). Hypoechogenic plaques assessed by ultrasound were a significant risk factor for MES (P = .001). The features of plaque vulnerability, such as hemorrhagic component (P = .011), neovascularization (P = .025), signs of inflammation (P = .027), and rupture of the fibrous cap (P = .002) were predictors of MES. Cap rupture was the only predictor in the multivariate analysis (odds ratio, 5.98; P = .030). The stenosis severity was not associated with MES (P = .95) CONCLUSIONS: Patients under best medical therapy had a preoperative embolic activity becoming no more detectable after surgery. Both ultrasound and histologic markers of vulnerability were predictors of MES, and stenosis severity was not associated. TCD gives better insight into the real embolic risk, and future studies should evaluate clinical results coming from its implementation with standard imaging techniques. CLINICALTRIAL: gov registration number NCT05134493.

Systematic review and meta-analysis of long-term reintervention following thoracic endovascular repair for blunt traumatic aortic injury.

OBJECTIVE: To investigate the long-term reinterventions of thoracic endovascular repair (TEVAR) after blunt traumatic aortic injury. METHODS: MEDLINE, EMBASE, and Cochrane databases were interrogated until June 2021. Inclusion criteria were blunt traumatic aortic injury treated with TEVAR and mean follow-up of more than 60 months. A systematic review was conducted and data were pooled using a random effects model of proportions applying the Freeman-Tukey transformation. Late reintervention was the primary outcome. Secondary outcomes were procedure-related complications (endoleak, in-stent thrombosis, occlusion, infolding/collapse, bird-beak, migration, and left arm claudication), overall and aortic-related mortality, and aortic diameter changes. RESULTS: Eleven studies with a low quality assessment were included. Four hundred eight patients were collected and the 389 surviving more than 30 days were included. The mean follow-up was 8.2 years (95% confidence interval [CI], 5.7-10.8; I2 = 40.2%). Late reintervention was 2.1% (95% CI, 0.6-3.9; I2 = 0.0%; 11/389 cases) with 0.1% (95% CI, 0.0-1.2; I2 = 0.0%; 3/389) occurring after 5 years. Bird-beak was identified in 38.7% (95% CI, 16.4-63.6; I2 = 86.6%). Left arm claudication occurring after 30 days was 3.1% (95% CI, 0.1-8.6; I2 = 26.9%; 11/140 cases). In-stent thrombosis was 1.9% (95% CI, 0.1-5.2; I2 = 51.8%; 11/389 cases). Endoleak was 0.5% (95% CI, 0.0-1.9; I2 = 0.0%; 5/389 cases). Infolding, occlusion, and migration were reported in 2 of 389, 1 of 389, and 0 of 389 patients, respectively. Overall late survival was 95.6% (95% CI, 88.1-99.8; I2 = 84.7%; 358/389 patients) and only one patient accounted for aortic related mortality. The increase in proximal and distal aortic diameters was estimated at 2.7 mm (95% CI, 1.2-4.3; I2 = 0.0%) and 2.5 mm (95% CI, 1.1-3.9; I2 = 0.0%), respectively. CONCLUSIONS: TEVAR demonstrates remarkably good long-term results and reinterventions are rarely required. Aortic reinterventions tend to occur within the first and after the fifth year.

Analysis of predisposing factors for type III endoleaks from directional branches after branched endovascular repair for thoracoabdominal aortic aneurysms.

BACKGROUND: Mid-term durability of branches has already been established, and BF-branched and fenestrated endovascular repair has shown comparable results with open repair in the treatment of thoracoabdominal aortic aneurysms (TAAAs). Nevertheless, target vessel instability remains the most frequent adverse event after complex endovascular aortic repair. Type III endoleaks from directional branches have been reported with a low incidence, but risk factors for this complication have not been investigated yet. METHODS: This was a dual-center observational retrospective cohort study. Data were collected prospectively for each patient treated with branched endovascular repair between April 2008 and December 2019. The primary outcome was to assess potential risk factors for branch disconnection and fracture. A logistic regression analysis was performed, including preoperative and postoperative measurements as well as intraoperative details. A Cox regression hazard analysis was performed to evaluate the influence of preoperative aneurysm diameter and target vessel angulation on the outcome during follow-up. RESULTS: Two hundred ninety-five target visceral vessels (TVVs) in 91 patients were considered suitable for cannulation. Technical success was 96.9% (286/295 TVVs). The median follow-up was 32.5 months (interquartile range, 14.2-50.1 months). Twelve type III endoleaks from directional branches were detected (4.2%; 5 bridging stent graft fractures and 7 disconnections). Five type III endoleaks involved the celiac trunk (one fracture and four disconnections), five the superior mesenteric artery (four fractures and one disconnection), and two the renal arteries (both disconnections). The median time to type III endoleak was 22.2 months (interquartile range, 10.9-37.6 months). Preoperative TAAA diameter (P = .028), preoperative TVV angulation (P = .037), the use of a BeGraft stent graft as bridging stent graft (P = .001), and different stent types on the same vessel (P = .048) were associated with type III endoleak at univariable analysis. Using a BeGraft stent graft (P = .010) was the only significant factor predisposing to type III endoleak at multiple logistic regression. The Cox regression analysis showed a two-fold increased risk for type III endoleak for every 10-mm increase in preoperative TAAA diameter (hazard ratio, 2.00; 95% confidence interval, 1.08-3.72; P = .028) and a 1.5 increased risk every 12° increase of preoperative TVV angulation (hazard ratio, 1.47; 95% confidence interval, 1.02-2.10; P = .037). CONCLUSIONS: Type III endoleaks from directional branches are a non-negligible complication after branched endovascular repair, with a relevant incidence. They tended to be clustered on specific patients, and aneurysm diameter and TVV angulation are strictly associated with the outcome. Different stent types on the same vessel should be avoided whenever possible. An intensified follow-up should be adopted for patients with large aneurysms, implanted with first-generation BeGraft, or who have been already diagnosed with type III endoleaks.

Comprehensive Learning Curve Analysis of a Long-Term Experience With Thoracic Endovascular Aneurysm Repair.

PURPOSE: To analyze the learning curve for thoracic endovascular aortic repair (TEVAR) in a single center over a period of 25 years. MATERIALS AND METHODS: In total, 390 consecutive standard TEVAR procedures undertaken between 1996 and 2021 were included in a retrospective, observational, single-center study. Cumulative sum charts were elaborated for the entire center experience (primary outcome) as well as for the first and second implanting physicians. Data on procedural variables (contrast volume, operative and fluoroscopy time), 30-day major adverse events (MAEs) and clinical success, and endoleak and reintervention rates were secondary outcomes and subdivided into 4 quartiles of experience (Q1-Q4) or presented as first 2 versus latest 2 quartiles (Q1-Q2 vs Q3-Q4). RESULTS: The mean follow-up was 4.3±4.0 years. The center's learning curve was achieved after 75 procedures, and it was similar for the first implanting physician. The surgeon coming thereafter had a significantly shorter curve (10 TEVARs). Comparing Q1-Q2 with Q3-Q4, 30-day MAEs (16.1 vs 11.3%, p=0.164), 30-day mortality (11.4% vs 3.6%, p=0.003), and intraoperative additional maneuvers (21.5% vs 13.3%, p=0.033) were reduced along with an improvement in clinical success (85.9% vs 90.3%, p=0.190). From Q1 to Q4, operative time (139.8±65.5 to 76.7±43.7 min, p=0.001), fluoroscopy time (15.1±8.8 to 7.1±5.1 min, p<0.001), and contrast volume (244.0±112.1 to 104.3±46.1 mL, p<0.001) showed a considerable reduction. Late endoleak and aortic-related mortality declined significantly from Q1-Q2 to Q3-Q4 (24.1% to 15.5%, p=0.033 and 18.6% vs 8.2%, p=0.006, respectively). Operative time (p=0.021), contrast volume (p=0.016), and fluoroscopy time (p=0.004) were independent risk factors for endoleak, causing a 1.3-fold risk increase for both each 60 minutes of additional operative time (p=0.021) and every 100 mL of additional contrast medium (p=0.016). Each 10-minute increase in fluoroscopy time determined a 1.4-fold risk increment (p=0.004). CONCLUSION: The learning curve shortened significantly over time with non-negligible clinical outcome improvements, suggesting that specific endovascular training is mandatory to become an effective TEVAR performer. CLINICAL IMPACT: For the first time in literature, the standard TEVAR's learning curve has been evaluated at a single vascular surgery center over a period of 25 years. The learning curve for the center and the first physician historically undertaking TEVAR was achieved at the 75th treated patient. The learning curve of the surgeons coming thereafter was significantly shorter (10 cases). This quarter-century demonstrated that intraoperative learning-related variables were associated with long-term clinical outcomes and all have improved over time. Centers approaching TEVAR for the first time and training program providers could use these data to aim to offer better clinical outcomes.

Anatomical Feasibility of an Off-the-shelf Single-Renal Scalloped Stent-Graft for Hostile Neck Abdominal Aortic Aneurysm: A Preclinical Study.

OBJECTIVES: To evaluate the feasibility of a standardized single-renal scallop stent-graft. DESIGN: Preclinical, single-center, real-world, all-comers, retrospective cohort study. METHODS: A total of 1347 abdominal aortic aneurysm (AAA) repairs (endovascular and open) performed between 2010 and 2020 were screened for elective treatment and retrievable preoperative high-quality computed tomography angiography (CTA) performed <6 months of the surgical procedure. Six hundred of the included CTAs involved prespecified measurements and a morphological assessment protocol (NCT05150873). The proximal sealing zones suitable for standard stent-graft implantations were further analyzed (N=547). The primary outcome assessed the feasibility of 2 single-renal scallop designs (10×10 mm and 15×10 mm, height × width). The feasibility was the inter-renal length ≥10 mm and ≥15 mm for prototypes #10 and #15, respectively. The secondary outcome quantified hypothetical length and surface improvements comparing those suitable for investigational devices implantation (study group) versus those not (control group). RESULTS: Of the total, 24.7% (n=135) was feasible with prototype #10. The study versus control group sealing zones were shorter (p=0.008), with a smaller surface (p=0.009) and a higher alpha angle (p=0.039). The length and surface area increased by about 25% and 23%, respectively, (both p<0.001) within the study group and became significantly better versus the control group (standard stent-graft; both p<0.001). Of the total, 7.1% (n=39) was suitable for prototype #15. The study versus control group sealing zones were shorter (p=0.148), with a smaller surface (p=0.077) and a higher alpha angle (p=0.027). The length and surface area increased by about 34% and 31%, respectively, (both p<0.001) within the study group and became significantly higher versus the control group (standard stent-graft; both p<0.001). CONCLUSIONS: The use of single-renal scalloped stent-graft might be feasible in a considerable number of AAA patients. The breakthrough stands in treating hostile AAAs presenting in mismatched renal arteries, keeping the complexity of the repair as similar as possible to standard endovascular repair with a remarkable improvement in sealing. CLINICAL IMPACT: The anatomic feasibility of a single renal stent graft for the treatment of "hostile" abdominal aortic aneurysm (AAA) with mismatched renal arteries was evaluated. The experimental device could be feasible in a considerable number of patients with AAA, approaching 25%, and demonstrate significant improvements in sealing. As far as we know, this is the first paper to report the prevalence of mismatched renal arteries in a large cohort of AAA patients in the real world, while proposing a dedicated device. The breakthrough is to keep the complexity of the repair as close as possible to standard endovascular repair.

Celiac Artery Coverage After Thoracic Endovascular Aortic Procedure: A Meta-Analysis of Early and Late Results.

BACKGROUND/AIM: Clinical outcomes of celiac artery (CA) coverage during aortic procedures are often contradicting and the fate of this additional maneuver is still unclear. This study summarizes the results of available literature and aims to clarify the impact of CA coverage during thoracic endovascular aneurysm repair (TEVAR) in patients with inadequate distal sealing zone. METHODS: Prospective and retrospective, observational original articles focused on CA coverage during elective/urgent TEVAR for descending thoracic aortic pathology (DTAP) were included. PubMed/MEDLINE, Embase, and Cochrane Central Register of Controlled Trials database were examined to identify articles published from January 2007 to December 2020, according to PRISMA guidelines. Early and late visceral (any sign or symptom reported) and neurological (both transient and permanent) complications were considered as primary outcomes. Onset of any endoleak, type IB endoleak, need of reintervention, and TEVAR-related mortality were considered as secondary outcomes. RESULTS: A total of 5618 articles were extracted for analysis and 13 studies were finally included in the synthesis. A total of 178 CAs were covered during 2653 TEVAR (7%). Spinal cord ischemia was 8% (95% CI, 5-14%, I2 0%) Any endoleak and type IB endoleak was observed in 12% (95% CI, 6-21%, I2 17%) and 5% (95% CI, 2-11%, I2 0%), respectively. Thoracic endovascular aneurysm repair-related reoperation was necessary in 8% (95% CI, 4-14%, I2 0%), the majority of which (14/18, 78%) performed for distal sealing failure; mortality rate was 9% (95% CI, 5-14%, I2 0%). Out of 178 patients, 168 (94%) were available for follow-up, ranged 12 to 42 months. Visceral complications, any endoleak, and type IB endoleak were identified in 15% (95% CI, 10-23%, I2 45%), 20% (95% CI, 13-29%, I2 8%), and 8% (95% CI, 4-15%, I2 0%), respectively. Thoracic endovascular aneurysm repair-related reintervention was required in 8% (95% CI, 4-14%, I2 0%). Mortality rate was 17% (95% CI, 12-25%, I2 4%). CONCLUSIONS: Celiac artery coverage in DTAP should be regarded as a "bailout" procedure especially in urgent/emergent settings but requires caution in elective cases. Even if transient visceral ischemia is frequent, life-threatening complications are rare. Early and late mortality rates are similar to standard TEVAR although the risk of type IB endoleak and reintervention may be an issue.

Incidence, Long Term Clinical Outcomes, and Risk Factor Analysis of Type III Endoleaks Following Endovascular Repair of Abdominal Aortic Aneurysm.

OBJECTIVE: To assess the real world incidence, outcomes, and risk factors of type III endoleaks (TIIIEL) after endovascular aneurysm repair (EVAR). METHODS: This was a single centre, retrospective, observational, cohort study. All patients with abdominal aortic aneurysms (AAAs) receiving EVAR between 1994 and 2020 were collected prospectively and reviewed. The primary outcome was the cumulative incidence and impact on survival of TIIIELs, either defined as disconnections of modular graft components (TIIIaEL) or fabric defects (TIIIbEL). Secondary outcomes included risk factor analysis evaluating baseline morphological and stent graft details, as well as a comparison of TIIIaEL and TIIIbEL. RESULTS: In total, 2 565 EVARs were performed and 95 (3.7%) TIIIELs were diagnosed at a median interval of 49.5 months (interquartile range [IQR] 19.4, 67.6). Estimated TIIIEL incidence at five years was 6.8%, 2.2%, and 3.6% for first and second generation, third and fourth generation, and fifth and sixth generation, respectively. The survival rate in patients without any high flow endoleak was 88.0%, 67.9%, 56.9%, and 52.1%, while in TIIIEL patients it was 98.6%, 77.2%, 49.8%, and 32.3% at one, five, 10, and 15 years, respectively (p = .77). The distribution of TIIIaEL and TIIIbEL was 70.5% and 29.5%, respectively. TIIIbEL received a higher rate of open treatment (28.6% vs. 7.5%; p = .005) and device or procedure related re-interventions (35.7% vs. 13.4%; p = .013). Fourteen (15.4%) recurrent TIIIELs were diagnosed at a median of 16.8 months (IQR 7.6, 32.1). Old generation endografts (hazard ratio [HR] 2.1, 95% confidence interval [CI] 1.3 - 3.4; p = .002) and non-proprietary extensions (HR 3.6, 95% CI 1.9 - 6.8; p < .001), and angulated and calcified aneurysm neck (HR 3.6, 95% CI 1.2 - 10.6; p = .017) were risk factors for TIIIEL. Every 10 mm maximum AAA diameter increase presented a 1.4 fold higher risk of TIIIEL. CONCLUSION: TIIIEL is a severe condition that is often fatal if left untreated. Old endografts, the implantation of non-proprietary extensions, large AAAs, and angulated and calcified necks are risk factors for TIIIEL that require careful follow up due to the high rate of recurrence.

Efficacy of adjunctive measures in peri-implant mucositis. A systematic review and meta-analysis.

AIM: To answer the following PICO question: In systemically healthy humans with peri-implant mucositis, what is the efficacy of patient-performed or administered (by prescription) measures used adjunctively to submarginal instrumentation, as compared to submarginal instrumentation alone or combined with a negative control, in terms of reducing bleeding on probing (BOP), in randomized controlled clinical trials (RCTs) with at least 3 months of follow-up? MATERIALS AND METHODS: Three databases were searched until April 2022. Weighted mean differences (WMDs) with 95% confidence intervals (CIs) and predictive intervals were calculated. RESULTS: Sixteen parallel RCTs corresponding to 14 studies with low/moderate risk of bias were included. Test groups showed greater reductions in BOP (%) than control groups (nstudies  = 16; npatients  = 650; WMD = 14.25%; 95% CI [9.06-19.45]; p < .001; I2  = 98.7%). The greatest WMD in BOP reductions (%) were obtained by antiseptics (ns  = 5; np  = 229; WMD = 22.72%; 95% CI [19.40-26.04]; p < 0.001; I2  = 94.8%), followed by probiotics (ns  = 6; np  = 260; WMD = 12.11%; 95% CI [3.20-21.03]; p = .008; I2  = 93.3%) and systemic antibiotics (ns  = 3; np  = 101; WMD = 5.97%; 95% CI [1.34-10.59]; p = .012; I2  = 58.1%). Disease resolution was scarcely reported (n = 6). CONCLUSIONS: Significant clinical improvements can be obtained when professional submarginal instrumentation is combined with patient-performed or administered (by prescription) adjunctive measures, although a complete disease resolution may not be achieved.

Acute-phase response following one-stage full-mouth versus quadrant non-surgical periodontal treatment in subjects with comorbid type 2 diabetes: A randomized clinical trial.

AIM: To compare the level of inflammatory markers and endothelial function 24 h (Day 1) and 90 days (Day 90) after conventional quadrant-wise scaling and root planing (Q-SRP) versus one-stage full-mouth SRP (FM-SRP) in patients affected by type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS: Patients affected by periodontitis and T2DM were randomly allocated to receive FM-SRP or Q-SRP and followed up at Day 1 and Day 90. Serum samples, vital signs, and flow-mediated dilation (FMD) parameters were collected at baseline, Day 1, and Day 90. Periodontal variables were collected at baseline and Day 90. The primary outcome was the C-reactive protein (CRP) concentration at Day 1 after periodontal treatment. Student's t-test for independent samples was used for between-group comparisons (Mann-Whitney U test for non-normal data), while analysis of variance with post hoc Tukey tests (Kruskal-Wallis and Dunn tests for non-normal data) were used for intra-group comparisons. RESULTS: Forty subjects were included in the study. FM-SRP produced a significant increase in CRP and a significant reduction in FMD at Day 1 compared to Q-SRP (p < .05). The absolute change in HbA1c (mmol/mol) from baseline to Day 90 was significantly improved in the Q-SRP (ΔHbA1c = -1.59 [SD = 1.20]) compared to the FM-SRP group (ΔHbA1c = -0.8 [SD = 0.95]) (p = .04). CONCLUSIONS: FM-SRP triggers a robust acute-phase response at 24 h after treatment compared to Q-SRP. Such systemic acute perturbations may offset the beneficial systemic effects of periodontal treatment in terms of HbA1c reduction and improvement in endothelial function in T2DM subjects.

Balloon Inducted Re-Lamination and False Lumen Thrombosis in Chronic Type B Aortic Dissection: Technique and Long-Term Results.

BACKGROUND: To evaluate the safety, feasibility, and effectiveness of the BAlloon Inducted re-Lamination and false lUmen Thrombosis (BAILOUT) as a simple technique to address the retrograde false lumen (FL) perfusion and subsequent aneurysmatic degeneration of the thoracic aorta due to a stent-graft crimped in a small true lumen in chronic Type B dissections. METHODS: An observational, retrospective, single-center study analyzing a nonconsecutive cohort of 8 patients affected by chronic type B aortic dissections already treated with thoracic endovascular repair and with an FL lumen backflow corrected with BAILOUT between 2006 and 2020. After a standard distal extension of the previously implanted graft, the distal end of the graft area was ballooned to completely rupture the dissection lamella to relaminate the aorta hindering the FL backflow. Computed tomography was routinely performed within the first postoperative week before discharge and then at 3 months, at 6 months, and yearly thereafter. The technical and clinical success rates were analyzed. Primary outcomes were safety and feasibility of the technique, secondary ones included FL thrombosis evaluation, and total aortic diameter analysis at the above-defined levels during the follow-up. Safety was defined if clinical success was reached. Feasibility was intended as technical success obtention. RESULTS: The technical and clinical success achieved was 100% with the complete interruption of FL backflow stating the safety and feasibility of the BAILOUT technique. No early procedure reinterventions were recorded and during a median follow-up of 62.5 months [interquartile range 43.2-94.1], only 1 death unrelated to the procedure was recorded. Freedom from aortic-related adverse events at 1 month, 3 months, 1 year, 5, and 7 years was 87.5%, 62.5%, 62.5%, 62.5%, and 62.5%, respectively. During the follow-up, no one increment of the diameter of the thoracic aorta was documented and all the patients at 3 years of computed tomography angiography showed a complete FL thrombosis. CONCLUSIONS: The BAILOUT technique demonstrates to be safe and feasible in this small cohort of patients as a simple and quick way to overcome the issue of FL backflow in chronic type B dissection. Small cohort and retrospective designs were limitations of the study.

Chimney Stenting Versus Surgical Debranching for the Treatment of Aortic Arch Pathologies-A Propensity-Matched Analysis.

BACKGROUND: Endovascular repair of aortic arch lesions requires revascularization of epiaortic vessels in case of coverage. The objective of this study was to compare the outcomes of surgical bypass versus endovascular reconstruction with a chimney graft. METHODS: A retrospective analysis of a multicenter register between January 2005 and December 2019 was performed. A total of 127 patients were included and divided into 2 groups: thoracic endovascular aortic repair + surgical debranching (n = 72) and thoracic endovascular aortic repair + chimney stenting (n = 55). The main end points were major neurologic sequelae and type IA endoleak. Propensity score matching was performed to analyse baseline variables related to these outcomes. RESULTS: The mean follow-up was 35.6 months for the debranching group and 34.1 for the chimney group (P = 0.65). The incidence of stroke was higher in the chimney group although not statistically significant (7.3% vs. 4.1%; P = 0.46); for both groups, a wide angle between the ostium of the target vessel and the aorta and landing in Ishimaru Zone 0 was found to be the main predictors for major neurologic sequelae (P = 0.002 and P = 0.003, respectively). During follow-up, 9 (12.5%) type IA endoleaks occurred in the debranching group and 12 (21.8%) in the chimney group (P = 0.14). Aortic diameter larger than 66 mm and arch angle >46° had a strong association with proximal endoleak incidence (P = 0.001 and P = 0.011, respectively) CONCLUSIONS: Surgical debranching showed better results than chimney stenting in terms of major neurologic events incidence and type IA endoleak, although the difference between the groups was not statistically significant. Further research with larger cohorts is needed to establish the indications for these procedures.