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.

Preliminary results from an Italian National Registry on the outcomes of the Najuta fenestrated aortic arch endograft.

BACKGROUND: Arch pathology represents one of the last frontiers in aortic aneurysm endovascular management. Several companies recently developed dedicated branched and fenestrated endografts specifically designed for the aortic arch, aiming to overcome some of the issues associated with standard thoracic endograft and supra-aortic vessels extra-anatomic debranching. This study aimed to evaluate early outcomes obtained with a custom-made fenestrated endograft approved for thoracic aortic aneurysms exclusion. METHODS: All consecutive patients treated with the Najuta endograft (Kawasumi Laboratories, Inc, Tokyo, Japan) in Italy were enrolled prospectively and included in the study population. Anatomic characteristics and perioperative data were analyzed retrospectively. Study end points were technical success, 30-day clinical success, overall survival, supra-aortic vessel patency, endoleak, and need for reintervention or surgical conversion. RESULTS: Between 2018 and 2022, 76 patients received a Najuta endograft in Italy and were enrolled in the study. The median patient age was 72 years (interquartile range, 69-76 years) and 80.3% were male. Most of the patients received treatment for atherosclerotic aneurysms (80.3%); others were treated for postdissection aneurysms (7.9%), penetrating aortic ulcer (9.2%), or type I endoleak correction after previous thoracic endovascular repair (2.6%). Overall, 161 supra-aortic vessels were preserved through a dedicated fenestration. Technical success was achieved in 74 of 76 procedure (97.4%); both failures were associated with endoleak detection at final angiography (one type I and one type III endoleak). Two distal migrations occurred during the implanting procedure. Clinical success at 30 days was 94.7%. Two early reinterventions were needed within 30 days after index procedure: in one case, an aortic false lumen coils embolization was performed, because distal re-entry caused enlargement of the postdissection thoracic aneurysm. The other procedure consisted of a femoral pseudoaneurysm repair. The median follow-up was 7 months (interquartile range, 3-15 months); no supra-aortic vessel occlusions occurred and no patients needed surgical conversion. CONCLUSIONS: Early results suggest that, in selected patients with aortic arch pathology needing a proximal landing, an endovascular approach with the Najuta system is safe and effective, especially for those at high surgical risk. A strict follow-up with high-quality computed tomography angiography images and eventual evaluation for long-term complications is needed to confirm these initial experience findings.

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.

Two Decades of Abdominal Aortic Endovascular Repair With the Anatomical FiXation at the Aortic Bifurcation in a Large Single-Center Experience.

OBJECTIVE: The introduction of new endograft models improved long-term results of abdominal aortic aneurysm (AAA) endovascular repair (EVAR), but most of them maintained an old and unchanged design: a short body and long legs shifting up the flow divider. This study assessed the long-term results of EVAR with unimodular endoprosthesis fixed at the aorto-iliac bifurcation (Anatomical FiXation), in a large, unselected cohort. MATERIALS AND METHODS: In a single-center, retrospective cohort study, 623 patients selectively treated between 1999 and 2016, were analyzed. Follow-up protocol included at least a computed tomography angiography within 3 months and a duplex ultrasound and clinical exam yearly. All enrolled patients were analyzed by 2020. The primary outcomes were technical success, clinical success, and survival. Secondary outcomes included survival-free from late-open-conversion (LOC), reintervention, and endoleaks. RESULTS: Median age was 74±11 years and the follow-up 93±54 months. The technical success was achieved in 99.4% and the 30-day clinical success was 98.4%. A 5-year clinical success of 97.7% was registered and at 10 years success was 96.7%. The overall survival at 1, 5, 10, and 15 years was 92.4%, 79.5%, 64.9%, and 45.5%, respectively. Six (0.98%) AAA-related death were registered, 3 caused by infection of the endograft and 3 for secondary rupture. LOCs were 9 (1.47%) and reintervention-free survival at 1, 5, 10, and 15 years were 88.4%, 78.0%, 76.2%, and 74.6%, respectively. Freedom from endoleaks was 88.8% at 1 year and 72.7% at 15 years. A total of 63 high-flow endoleaks were registered (43 type I, 7 type IIIa, 12 type IIIb, and 1 type Ib+IIIb). No migrations were recorded, and the graft limb thrombosis rate was 1.14%. From a multivariate analysis resulted that long-term clinical success appeared to be reduced in patients affected by diabetes [odds ratio (OR) 0.24; p=0.04] and in presence of calcified and thrombotic iliac accesses (OR 0.16; p=0.006). CONCLUSION: EVAR with the Anatomical FiXation was confirmed to be safe, feasible, and effective to prevent AAA rupture in the long term as well. However, the overall survival remains afflicted by cardiovascular accident. The original concept of unibody bifurcated design allowed a very low rate of graft thrombosis and zeroed the risk of migration and related reintervention.

Endoleak outcomes with different stent-graft generations in a 25-years thoracic endovascular aortic repair experience.

INTRODUCTION: To compare endoleak outcomes after thoracic endovascular aneurysm repair (TEVAR) with different stent-graft generations into long-term follow-up. DESIGN: retrospective, observational, and single-center cohort study. METHODS: TEVAR procedures performed between November 1995 and December 2020 were analyzed. The primary endpoint of this study was the freedom from endoleak (type I/III) in four stent-graft generations during the follow-up period. The first generation (GEN1) included: Vanguard; AneuRx and Talent; Stentor; Excluder; Endologix; EndoFit. The second generation (GEN2) included: TAG and TX. The third (GEN3) included: Relay Plus; Valiant Captivia; Zenith Alpha and custom-made. The fourth (GEN4) included: Relay Pro; Conformable C-TAG; Navion; E-Vita; Najuta; Nexus; standard and custom-made thoraco-abdominal devices. Nonaortic and aorta-related survival was considered as secondary outcome. RESULTS: A total of 509 TEVAR were included with a 44.3 ± 42.5 months mean follow-up. Freedom from endoleak at 5 years was 65.6%, 61.4%, 76.2%, and 69.1% for GEN1, GEN2, GEN3, and GEN4, respectively (p = 0.368). The first two generations demonstrated a higher endoleak rate when compared with the two most recent ones (27.2 vs 18.2%, respectively; p = 0.043). GEN1 was an independent risk factor (p = 0.014) and GEN4 was an independent protective factor (p = 0.001) for endoleak. GEN1 was found to be a risk factor for type-Ia endoleak (p = 0.059). GEN4 demonstrated a protective association regarding type-Ib endoleak (p = 0.012). Overall survival was 75.3%, 44.4%, 27.2%, and 17.6% at 1, 5, 10, and 15 years, respectively. Survival distinguished as non-related versus aortic-related was 86.7% vs 23.5%, 52.7% vs 9.8%, 32.9% vs 2.0%, 21.2% vs 0% at 1, 5, 10, and 15 years, respectively (p< 0.000). CONCLUSION: Endoleak occurred in a non-negligible percentage of TEVAR patients. A significant reduction of endoleak incidence over evolving stent-grafts generations was registered. Newer stent-graft generations demonstrated better long-term endoleak. Data about long-term outcomes require ongoing updates to prove both the reliability and the durability of newer stent-graft generations.

Outcome of Endovascular Repair of Popliteal Artery Aneurysms using the Supera Stent.

PURPOSE: To evaluate the efficacy of endovascular repair of popliteal artery aneurysms (PAAs) with a wire-interwoven nitinol stent. MATERIALS AND METHODS: This is a prospective, descriptive, and analytical study. From January 2016 to December 2018, 28 consecutive patients (29 lower limbs) were treated for a PAA with the deployment of the Supera stent (Abbott Vascular, Illinois). Twenty-three (79.3%) PAAs were asymptomatic; 6 (20.7%) presented with symptoms. The mean diameter and length of the aneurysm were 26.8 mm (20-40 mm) and 47.1 mm (23-145 mm) respectively. The primary endpoint was the prevention of embolic symptoms. The secondary endpoints were aneurysm exclusion, aneurysm diameter decrease, freedom from reintervention, and preservation of preoperative runoff vessels. RESULTS: Technical success was 100%, with a median of 2.4 run-off vessels at completion angiography, without any loss of run-off vessels. A double Supera stent was deployed in 10 cases. At completion angiography, a median of 2.4 runoff vessels were present, without any loss of runoff vessels. The mean follow-up time was 24.3 (12-35) months. Primary endpoints were reached in 100% of the cases and vessels run off was preserved in all cases. In 2 PAAs, complete sac thrombosis was witnessed at 6-month follow-up, while at 12-month follow-up, it was seen in 10 of 29 (34.4%) limbs. In all the other cases the diameter of the aneurysm remained stable, with a freedom from sac enlargement of 100%. No fractures or stent thromboses were detected. CONCLUSIONS: For endovascular repair of PAAs, the use of a thick interwoven-wire stent, that could work like a multilayer flow modulator showed encouraging mid-term results with no cases of stent fracture, occlusion or aneurysm increase.

Endovascular occlusion of an aortic coarctation after thoracic endovascular aortic repair of an anastomotic aneurysm.

A 58-year-old man with a history of aortic and mitral mechanical valve replacement was referred to our hospital for symptomatic chronic heart failure. In 1988, he had undergone open surgical correction of an isthmic aortic coarctation (CoA), with the creation of an extra-anatomic bypass from the left subclavian artery to the descending thoracic aorta. The following findings were found: severe mitral valve failure with perivalvular leakage, severe aortic valve stenosis, pulmonary hypertension, distal anastomotic aneurysm with the apparent occlusion of the CoA. A thoracic endovascular aneurysm repair was performed. A postoperative high-pressure leak with no evident signs of ineffective sealing was observed. Computed tomography angiography (CTA) 3D reconstruction demonstrated the recanalization of the CoA. A second procedure was planned. The CoA was anterogradely cannulated. Three coils were deployed into the aneurysmal sac, followed by a vascular plug, positioned on the coarctation conduit, but it failed to anchor and dislocated into the sac. A second plug was deployed, but it also partially dislocated. Finally, a patent foramen ovale occluder device was deployed to occlude the communication. The final angiogram showed the complete occlusion of the coarctation and correction of the leak, which was confirmed by a 6-month post-operative CTA.

Health-related quality of life outcomes and hospitalization length of stay after micro-fragmented autologous adipose tissue injection in minor amputations for diabetic foot ulceration (MiFrAADiF Trial): results from a randomized controlled single-center clinical trial.

BACKGROUND: The diabetic foot ulcer (DFU) is a high prevalence complication that significantly impairs the health-related quality of life (HRQoL) and is characterized by prolonged hospital length of stay (LOS). The impact of the micro-fragmented autologous adipose tissue injection at the minor amputation wound in the case of DFU (MiFrAADiF) on HRQoL and LOS compared to the standard care has not been determined yet. METHODS: This was a two-arm, 6-month, individually-randomized controlled single-center clinical trial. A 1:1 randomization to local injection of autologous micro-fragmented adipose tissue (treatment group; N.=57) or standard clinical care (control group; N.=57) was performed. The primary objective was the HRQoL. The secondary endpoint was the LOS. HRQoL was assessed with the Medical Outcomes Study 36-item Short-Form Health Survey which provides 2 scores focused on physical (PCS) and mental functioning (MCS). The trial was registered in ClinicalTrials.gov (NCT03276312). RESULTS: The type of treatment (P=0.009) and the time elapsed since surgery (P=0.0000) demonstrated a significant improvement on PCS. The MCS improvements resulted in a non-significant association with treatment (P=0.21). The time elapsed since surgery showed a significant influence on the MCS (P=0.0000). The mean LOS was 16.2 days and 24.4 days for the treatment and the control group respectively (P=0.025). CONCLUSIONS: The MiFrAADiF Trial demonstrated a significant improvement in terms of physical HRQoL and a significant reduction of the hospital length of stay after injection of micro-fragmented autologous adipose tissue in diabetic patients' minor amputations wound.

Autologous micro-fragmented adipose tissue for the treatment of diabetic foot minor amputations: a randomized controlled single-center clinical trial (MiFrAADiF).

BACKGROUND: The diabetic foot ulcer (DFU) is one of the most prevalent complications of diabetes mellitus and often develops severe effects that can lead to amputation. A non-healing "minor" amputation often precedes a major amputation resulting in a negative impact on the function and quality of life of the patients. Stem cell-based therapies have emerged as a promising option to improve healing, and the adipose tissue is an abundant and easy to access source. The injection of autologous micro-fragmented adipose tissue at the amputation stump of a diabetic population undergoing a lower limb minor amputation was evaluated and compared with the standard care. METHODS: In this randomized controlled trial with two arms (parallel assignment) and no masking, 114 patients undergoing a lower limb minor amputation were randomized to standard of care or to micro-fragmented adipose tissue injection prepared using a minimal manipulation technique (Lipogems®) in a closed system. Clinical outcomes were determined monthly up to 6 months. Primary endpoint of the study was the evaluation of the healing rate and time after the minor amputation. Secondary endpoints included the assessment of safety, feasibility, technical success, relapse rate, skin tropism, and intensity of pain. RESULTS: At 6 months, 80% of the micro-fragmented adipose tissue-treated feet healed and 20% failed as compared with the control group where 46% healed and 54% failed (p = 0.0064). No treatment-related adverse events nor relapses were documented, and technical success was achieved in all cases. The skin tropism was improved in the treatment group, and the pain scale did not differ between the two groups. CONCLUSION: The results of this randomized controlled trial suggest that the local injection of autologous micro-fragmented adipose tissue is a safe and valid therapeutic option able to improve healing rate following minor amputations of irreversible DFU. The technique overcomes several stem cell therapy-related criticisms and its potential in wound care should be better evaluated and the therapeutic indications could be expanded. TRIAL REGISTRATION: ClinicalTrials.gov number: NCT03276312. Date of registration: September 8, 2017 (retrospectively registered).