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1.
J Vasc Surg ; 2024 Jun 20.
Article in English | MEDLINE | ID: mdl-38908806

ABSTRACT

OBJECTIVE: The aim of this study was to report the outcomes of endovascular urgent thoracoabdominal aortic (TAAA) repair, using an off-the-shelf preloaded inner branch device (E-nside; Artivion). METHODS: Data from a physician-initiated national multicenter registry, including patients treated with E-nside endograft (INBREED) were prospectively collected (2020-2024); only urgent cases were included in this study. Primary outcomes were technical success and mortality at 30 days. Secondary outcomes were spinal cord ischemia rate, stroke rate, major adverse events (MAE) as also branch instability at 12 months. RESULTS: Of 185 patients enrolled in the INBREED, 64 (34.5%) were treated in a urgent setting and were included in the study. Reason for urgent repair was presence of aneurysm-related symptoms in 31 patients (48.4%), a contained rupture in eight (12.5%), and a large aneurysm >80 mm in 25 (39.1%). Extent of repair was I to III in 32 patients (50%) and IV in 32 (50%); 18 (28%) had a narrow (<25 mm) paravisceral aortic lumen. An adjunctive proximal thoracic endograft was deployed in 29 patients (45.3%); a distal bifurcated abdominal endograft was used in 33 (51.5%). Two hundred forty-nine target vessels (97.2%) were successfully incorporated through an inner branch from an upper arm (81.2%) or femoral (18.8%) access. A balloon expandable stent was used in 184 (75.7%) target vessels, a self-expandable stent in 59 (24.3%). Mean time for target vessel bridging was 39.9 ± 28.4 minutes per target vessel. Thirty-day cumulative major adverse event (MAE) rate was 28%, and mortality occurred in five patients (9.1%). There was one postoperative stroke (1.6%), and the spinal cord ischemia (SCI) rate was 8% (n = 5). For the 249 target vessels successfully incorporated through an inner branch, 1-year freedom from target vessel instability was 93% ± 3% after 1 year. CONCLUSIONS: The E-nside represents a valid solution for the urgent treatment of TAAAs, including symptomatic and ruptured TAAAs, as well as large asymptomatic TAAAs that cannot wait for a custom-made device. The preloaded inner branches and available proximal and distal graft diameters might be useful in urgent settings and provided satisfactory early and 1-year results, in terms of both endograft and target vessel stability. Further studies are required to assess the clinical role of E-nside for urgent TAAA repair.

2.
Bioengineering (Basel) ; 10(3)2023 Mar 01.
Article in English | MEDLINE | ID: mdl-36978707

ABSTRACT

Aortic dissection is a life-threatening vascular disease associated with high rates of morbidity and mortality, especially in medically underserved communities. Understanding patients' blood flow patterns is pivotal for informing evidence-based treatment as they greatly influence the disease outcome. The present study investigates the flow patterns in the false lumen of three aorta dissections (fully perfused, partially thrombosed, and fully thrombosed) in the chronic phase, and compares them to a healthy aorta. Three-dimensional geometries of aortic true and false lumens (TLs and FLs) are reconstructed through an ad hoc developed and minimally supervised image analysis procedure. Computational fluid dynamics (CFD) is performed through a finite volume unsteady Reynolds-averaged Navier-Stokes approach assuming rigid wall aortas, Newtonian and homogeneous fluid, and incompressible flow. In addition to flow kinematics, we focus on time-averaged wall shear stress and oscillatory shear index that are recognized risk factors for aneurysmal degeneration. Our analysis shows that partially thrombosed dissection is the most prone to false lumen degeneration. In all dissections, the arteries connected to the false lumen are generally poorly perfused. Further, both true and false lumens present higher turbulence levels than the healthy aorta, and critical stagnation points. Mesh sensitivity and a thorough comparison against literature data together support the reliability of the CFD methodology. Image-based CFD simulations are efficient tools to assess the possibility of aortic dissection to lead to aneurysmal degeneration, and provide new knowledge on the hemodynamic characteristics of dissected versus healthy aortas. Similar analyses should be routinely included in patient-specific hemodynamics investigations, to plan and design tailored therapeutic strategies, and to timely assess their effectiveness.

3.
J Vasc Surg ; 77(5): 1330-1338.e2, 2023 05.
Article in English | MEDLINE | ID: mdl-36621617

ABSTRACT

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.


Subject(s)
Aortic Aneurysm, Thoracic , Aortic Aneurysm , Aortic Diseases , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Humans , Male , Aged , Female , Blood Vessel Prosthesis/adverse effects , Blood Vessel Prosthesis Implantation/adverse effects , Endoleak/etiology , Endoleak/complications , Retrospective Studies , Risk Factors , Postoperative Complications/diagnostic imaging , Postoperative Complications/etiology , Postoperative Complications/therapy , Treatment Outcome , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/surgery , Aortic Aneurysm, Thoracic/complications , Aortic Aneurysm/surgery , Endovascular Procedures/adverse effects , Aortic Diseases/surgery , Prosthesis Design
4.
Diagnostics (Basel) ; 13(2)2023 Jan 16.
Article in English | MEDLINE | ID: mdl-36673138

ABSTRACT

RFA is a relatively new treatment, approved by the FDA in 1999 and is a minimally invasive intervention that has become one of the most common alternatives due to its many advantages, including decreased pain, less morbidity, shorter hospital stay and faster return to work. We retrospectively analyzed a total of 503 limbs submitted for surgical interventions for VVs using the RFA, combined or not with surgical phlebectomies and sclerotherapy, in our institution between April 2012 and December 2020. The technical success was 99.8%, as in one case the RFA catheter arrested at the first third of the thigh due to the tortuosity of the vessel. On the first post-operative day, the mean VAS scale was 0.32 ± 0.56 (0-2). Perioperative complications occurred in 77 cases (15.3%): intraoperative pain in 24 cases, in nine cases associated with vagal syndrome, superficial hematoma in 30 cases, EHIT in seven cases, phlebitis in 14 cases and paresthesia in two cases. RFA procedures had been shown to be cost-effective therapeutic options in adult patients requiring treatment due to the incompetence of the GSV. In our study, we highlighted that this technique is feasible as an ambulatory procedure; it improves quality of life and symptoms in the majority of patients with varicose veins, with a rapid return to normal life and work activities.

5.
Ann Surg ; 277(2): e460-e466, 2023 02 01.
Article in English | MEDLINE | ID: mdl-33714965

ABSTRACT

OBJECTIVE: To assess the initial clinical experience with a novel endograft system (NEXUS Aortic Arch Stent Graft System) designed to treat aortic arch pathologies and address the morphology and hemodynamic challenges of the aortic arch. SUMMARY BACKGROUND DATA: The aortic arch remains the most challenging part of the aorta for both open and endovascular repair. Transcatheter aortic arch repair has the potential to significantly reduce surgical risks. METHODS: Patients underwent transcatheter aortic arch repair with a single branch, 2 stent graft system, implanted over a through-and-through guidewire from the brachiocephalic trunk, to the descending aorta with an ascending aorta stent graft. The ascending aorta stent graft is deployed into a designated docking sleeve to connect the 2 stent grafts and isolate the aortic arch pathology. Proximal landing zone in all cases was in Zone 0. Anatomical inclusion criteria included adequate landing zone in the ascending aorta, brachiocephalic trunk, and descending thoracic aorta. Preparatory debranching procedure was performed in all patients with carotid-carotid crossover bypass and left carotid to left subclavian bypass, or parallel graft from descending aorta to left subclavian artery. Safety and performance were evaluated through 1 year. Survival analysis used the Kaplan-Meier method. RESULTS: Twenty-eight patients, 79% males, with a mean age of 72.2 ± 6.2 years were treated with 100% procedural success. Isolated aortic arch aneurysm was the principle pathology in 17 (60.7%) of patients, while chronic aortic dissection was the principle pathology in 6 (21.4%) of patients. The remaining 5 (17.8%) had combined or other pathologies. At 1 month, the vascular pathology was excluded in 25 of 26 alive patients (96.1%). The 30 days mortality rate was 7.1%, stroke rate was 3.6% (all nondisabling), and combined mortality/stroke rate was 10.7%. One-year mortality was 10.7%, without device or aneurysm-related death. Two patients (7.1%) reported stroke or transient ischemic attack at 1 year that recovered completely. One year combined mortality/stroke rate was 17.8%. There were 3 patients (10.7%) that had device-related unplanned reinterventions through 1 year. CONCLUSIONS: The NEXUS Aortic Arch Stent Graft System, a novel single branch, 2 stent graft system used for endovascular aortic arch repair that requires landing in the ascending aorta, demonstrates a high success rate with excellent 1 year safety and performance.


Subject(s)
Aortic Dissection , Stroke , Male , Humans , Aged , Female , Aorta, Thoracic/surgery , Aorta , Stents , Aortic Dissection/surgery
6.
Eur J Cardiothorac Surg ; 63(1)2022 12 02.
Article in English | MEDLINE | ID: mdl-36484696

ABSTRACT

OBJECTIVES: Endovascular aortic arch stent grafting with branched devices has shown initial promising results. The aim of this prospective, multicentre study was to evaluate 3-year outcomes of aortic arch stent grafting with NEXUS® Aortic Arch Stent Graft System (Nexus), a single-branch, bi-modular, off-the-shelf aortic arch stent graft system in high-risk patients. METHODS: Patients treated with Nexus, either under the feasibility clinical study or as compassionate use procedures in 5 centres, were included in this study. The primary end point was overall survival. The secondary end points included the incidence of procedure-related unplanned intervention, stroke, paraplegia and endoleak. Clinical and radiologic follow-up was performed at each study site at 30 days, 6 months and on a yearly basis thereafter up to 3 years postoperatively. RESULTS: We analysed data from a total of 28 patients. The overall median follow-up was 1132 (interquartile range: 809-1537). There were no device or procedure-related deaths between 1 and 3 years. Overall survival at 1 and 3 years was 89% and 71%, respectively. The cumulative incidence of unplanned reintervention at 1 and 3 years was 11% and 29%, respectively. There were no reports of stroke, paraplegia, aneurysm rupture, myocardial infarction or new aortic valve insufficiency. In this study's 1-3 year follow-up period, 1 type Ib (4%), 1 type II (4%) and 2 type III (8%; between Nexus' distal end and Thoracic endovascular aortic repair (TEVAR) extensions) endoleak were detected. CONCLUSIONS: Endovascular aortic arch exclusion with the single-branch, off-the-shelf Nexus system provides promising clinical and radiologic results at 3-year follow-up in a high-risk patient cohort.


Subject(s)
Aortic Aneurysm, Thoracic , Aortic Dissection , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Stroke , Humans , Blood Vessel Prosthesis/adverse effects , Endoleak/epidemiology , Endoleak/etiology , Endovascular Aneurysm Repair , Follow-Up Studies , Prospective Studies , Postoperative Complications , Stents/adverse effects , Stroke/etiology , Treatment Outcome , Retrospective Studies
7.
J Vasc Surg ; 76(2): 326-334, 2022 08.
Article in English | MEDLINE | ID: mdl-35314297

ABSTRACT

OBJECTIVES: To assess the outcomes of Cook t-Branch off-the-shelf multibranched stent graft in the treatment of complex aortic aneurysms with narrow internal aortic lumen. METHODS: Between 2016 and 2020, 48 patients (mean age, 73 years) underwent elective or urgent or emergent Cook t-Branch implantation for thoracoabdominal or para/juxtarenal aortic aneurysms in two Italian vascular centers. Among these, 20 patients presented a paravisceral or pararenal luminal diameter of less than 25 mm. Major clinical and radiologic outcomes of patients with narrow aortic lumen were compared with patients with a larger lumen in a multicenter, nonrandomized, retrospective fashion. RESULTS: The in-hospital mortality was 10% (5% in the elective setting). Spinal cord ischemia occurred in 6% of the cases. During a mean follow-up of 18 months (range, 1-63 months), late t-Branch procedure-related mortality and the need for reintervention was 0% and 12%, respectively. Comparing the outcomes of patients with large internal aortic lumen (group 1) with patients with small lumen (group 2), no significant difference was found regarding fluoroscopy time (P = .3); technical success (P = 1); early (P = .4) and late (P = 1) mortality; spinal cord ischemia (P = .2); bowel ischemia (P = .5); renal (P = .7), cardiac (P = 1), and respiratory complications (P = 1); reintervention rate (P = 1); and primary patency rate of stented target vessels (P = 1). CONCLUSIONS: The use of the Cook t-Branch in our experience was safe and effective in the treatment of complex aortic aneurysms regardless the caliber of the aortic lumen. With all the limitations of a small sample size, this approach has demonstrated to be feasible when maneuverability is decreased, with low mortality and morbidity, and acceptable reintervention rates. Perioperative mortality remains closely related to clinical presentation. Large-scale studies are needed to confirm these results.


Subject(s)
Aortic Aneurysm, Thoracic , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Spinal Cord Ischemia , Aged , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis/adverse effects , Blood Vessel Prosthesis Implantation/adverse effects , Endovascular Procedures/adverse effects , Humans , Postoperative Complications , Prosthesis Design , Retrospective Studies , Risk Factors , Spinal Cord Ischemia/etiology , Stents/adverse effects , Time Factors , Treatment Outcome
8.
J Pers Med ; 12(3)2022 Feb 24.
Article in English | MEDLINE | ID: mdl-35330339

ABSTRACT

Introduction: The aim of the present study is to report the outcome of patients presenting an isolated type II endoleak (TIIEL) requiring reintervention and to identify clinical and anatomical characteristics potentially implicated in refractory TIIEL occurrence and fate. Materials and Methods: A multicenter retrospective study on TIIEL requiring reintervention was conducted between January 2003 and December 2020. Demographic and clinical characteristics, procedural technical aspects, reinterventions, and outcomes were recorded. TIIEL determining sac expansion greater than 10 mm underwent a further endovascular procedure aiming to exclude aneurismal sac. Redo endovascular procedures were performed via endoleak nidus direct embolization and/or aortic side branches occlusion. TIIELs responsible for persisting aneurysmal sac perfusion 6 months after redo endovascular procedures were classified as "refractory" and submitted to open conversion. Results: A total of 102 TIIEL requiring reintervention were included in the final analysis. Eighty-eight (86.27%) patients were male, the mean age was 77.32 ± 8.08 years, and in 72.55% of cases the American Society of Anaesthesiologists (ASA) class was ≥3. The mean aortic diameter was 64.7 ± 14.02 mm, half of treated patients had a patent inferior mesenteric artery (IMA), and 44.11% ≥ 3 couples of patent lumbar arteries (LA). In 49 cases (48.03%) standard endovascular aneurysm repair (EVAR) procedure was completed without adjunctive maneuvers. All enrolled patients were initially submitted to a further endovascular procedure once TIIEL requiring reintervention was diagnosed; 57 patients underwent LAs or IMA embolization (55.87%), 42 transarterial aneurismal sac embolization (41.17%), and three (2.96%) laparoscopic ostial ligations of the inferior mesenteric artery. During a mean follow-up of 15.22 ± 7.57 months (7−48), a redo endovascular approach was able to ensure complete sac exclusion in 52 cases, while 50 patients presented a still evident refractory TIIEL and therefore a surgical conversion or semiconversion was conducted. At the univariate analysis refractory TIIEL patients were significantly different from those who did not develop the complication in terms of preoperative clinical, morphological characteristics, and initial EVAR procedures: coronary artery disease occurrence (p = 0.005, OR: 3.18, CI95%: 1.3−7.2); preoperative abdominal aortic aneurysm (AAA) sac diameter (p = 0.0055); IMA patency (p = 0.016, OR: 2.64, CI95%: 1.18−5.90); three or more patent LAs; isolated standard EVAR without adjunctive procedures (p > 0.0001; OR: 9.48, CI95%: 3.84−23.4). Conclusions: Our experience seems to demonstrate that it is reasonable to try to preoperatively identify those patients who will develop a refractory TIIEL after EVAR and those with a TIIEL requiring reintervention for whom a simple endovascular redo will not be enough, needing surgical conversion.

10.
Ann Vasc Surg ; 69: 454.e7-454.e11, 2020 Nov.
Article in English | MEDLINE | ID: mdl-32768550

ABSTRACT

Small-sized vessels can represent a contraindication to standard endovascular aortic repair (EVAR), and more specifically, aortoiliac deformities resulting from poliomyelitis may add an adjunctive challenge for total endovascular repair. Herein we report a case of a 62-year-old man with a 55 mm abdominal aortic aneurysm (AAA) and a history of poliomyelitis. More specifically, a computed tomography angiogram (CTA) showed a very narrow infrarenal aortic neck, measuring 13 mm in maximum diameter, and severely atrophic external iliac and common femoral arteries. A total endovascular repair was planned and realized with a single aortic JOTEC iliac branch and contralateral VBX placement. All prosthetic materials were delivered from the nonatrophic side. At the 1-year CTA, the aneurysm was successfully excluded and both iliofemoral axes were patent.


Subject(s)
Aorta, Abdominal/surgery , Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Iliac Artery/surgery , Poliomyelitis/complications , Stents , Aged , Aorta, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/complications , Aortic Aneurysm, Abdominal/diagnostic imaging , Atrophy , Humans , Iliac Artery/diagnostic imaging , Iliac Artery/pathology , Male , Poliomyelitis/diagnosis , Poliomyelitis/virology , Treatment Outcome
11.
Eur J Vasc Endovasc Surg ; 60(3): 395-401, 2020 Sep.
Article in English | MEDLINE | ID: mdl-32665199

ABSTRACT

OBJECTIVE: The objective of this prospective single centre study was to assess whether branches and fenestrations have different outcomes on renal function in the early phase. METHODS: From March 2018 to June 2019, 67 patients who underwent elective fenestrated and branched endovascular aneurysm repair (F/BEVAR) procedures were enrolled in this study. The patients were divided into two groups according to the renal bridging component configuration (fenestration vs. branch). All of them underwent dynamic renal scintigraphy with 99mTc diethylenetriaminepentaacetic acid (DTPA), two weeks pre-operatively, and three months and one year post-operatively. The primary end points were peri-procedural technical success, 30 day major adverse events, differences in glomerular filtration rate (GFR) between the branch and fenestration configurations, and variations between the pre-operative and the post-operative dynamic renal scintigraphy. RESULTS: Overall, 135 kidneys were analysed: 63 in the 32 patients treated with fenestrations, and 72 in the 35 patients treated with branches; the mean GFR on baseline scintigraphy was 58.4 ± 30.9 mL/min in the fenestration group, and 65.1 ± 29.2 mL/min in the branch group. Only kidneys associated with a patent fenestration/branch were included in the split GFR final analysis. The mean total GFR at three month scintigraphy decreased by 6.0 ± 2.9 mL/min in the fenestration group and by 23.4 ± 6.4 mL/min in the branch group. The split GFR decreased by 3.5 ± 0.6 mL/min in the fenestration group, and by 15.4 ± 5.4 mL/min in the branch group. The GFR decrease remained stable at one year. CONCLUSION: In this study, the use of branches for renal arteries during F/BEVAR resulted in a greater decrease in the GFR than in those patients who were treated with fenestrations alone. The scintigraphic alterations were evident at an early phase.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Kidney Diseases/diagnostic imaging , Radionuclide Imaging , Renal Artery/surgery , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/physiopathology , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/physiopathology , Blood Vessel Prosthesis Implantation/adverse effects , Endovascular Procedures/adverse effects , Female , Glomerular Filtration Rate , Humans , Kidney Diseases/etiology , Kidney Diseases/physiopathology , Male , Predictive Value of Tests , Prospective Studies , Prosthesis Design , Radiopharmaceuticals/administration & dosage , Renal Artery/diagnostic imaging , Renal Artery/physiopathology , Technetium Tc 99m Pentetate/administration & dosage , Time Factors , Treatment Outcome
13.
Ann Vasc Surg ; 62: 365-374, 2020 Jan.
Article in English | MEDLINE | ID: mdl-31560939

ABSTRACT

BACKGROUND: The aim of this study is to assess our experience and mid-term outcomes using Jetstream atherectomy system for treatment of femoropopliteal artery disease (FPAD). METHODS: Data of 30 patients with FPAD treated at our center between 2013 and 2016 were analyzed. Two subgroups of patients were identified: Group A included patients (n = 18) with de novo lesions; Group B (n = 12) included those with in-stent restenosis. The primary study end points assessed were technical success, perioperative mortality, and major adverse event (MAE) rate at 30 days (distal embolization, major amputation, and target lesion revascularization). Other outcomes measured were survival, primary, and secondary patency, and freedom from amputation at 1 and 3 years of follow-up, respectively. RESULTS: Technical success was 100% for both groups. The MAE rate was 8.7%. No distal filter was adopted during intervention. Angioplasty was associated with 93.3% of cases (93.3% vs. 100%; P = 0.15), drug-eluting balloon (DEB) in 12 cases (22.2% vs. 66.6%; P = 0.008), drug-eluting stent and bare metal implantation in 1 (5.6% vs. 0%; P = 1) and 4 cases (11.1% vs. 16.7%; P = 1), respectively. The cumulative primary and secondary patency rates were 75.1% and 95.5% at 1 year, and 70.4% and 84.8% at 3 years of follow-up, respectively. The survival and freedom from amputation were 96.4% and 85.8% at 1 and 3 years of follow-up, respectively. The freedom from target lesion revascularization was 91.7% and 83.4% at 1 and 3 years from intervention. CONCLUSIONS: The use of the Jetstream appears to be safe and feasible with no distal embolization and low rate perioperative complications. Moreover, encouraging outcomes were observed when atherectomy was associated to DEB angioplasty.


Subject(s)
Angioplasty, Balloon , Atherectomy/instrumentation , Femoral Artery , Peripheral Arterial Disease/therapy , Aged , Aged, 80 and over , Amputation, Surgical , Angioplasty, Balloon/adverse effects , Angioplasty, Balloon/instrumentation , Angioplasty, Balloon/mortality , Atherectomy/adverse effects , Atherectomy/mortality , Coated Materials, Biocompatible , Databases, Factual , Drug-Eluting Stents , Equipment Design , Female , Femoral Artery/diagnostic imaging , Femoral Artery/physiopathology , Humans , Italy , Limb Salvage , Male , Middle Aged , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/mortality , Peripheral Arterial Disease/physiopathology , Progression-Free Survival , Retrospective Studies , Risk Factors , Time Factors , Vascular Access Devices , Vascular Patency
14.
J Vasc Surg ; 72(1): 122-128, 2020 07.
Article in English | MEDLINE | ID: mdl-31784279

ABSTRACT

OBJECTIVE: Although the long-term results of endovascular aortic repair (EVAR) with low-profile devices in patients with hostile iliac anatomies have been published, there are no reported results specifically for narrow aortic bifurcations (NAB). This study investigated the outcomes of EVAR with the INCRAFT device in NAB (<16 mm). METHODS: This multicenter retrospective study involved five vascular surgery centers. From November 2014 until June 2018, 127 patients were treated with the INCRAFT device. The patient population was divided into two groups based on aortic bifurcation diameter. They were designated as the (1) standard aortic bifurcation (SAB) group (>16 mm) and the (2) the NAB group (<16 mm). Primary end points were the differences between the two groups in terms of technical success, survival at 30 days, iliac limb patency, and reinterventions. RESULTS: The SAB group included 96 patients and the NAB group included 31 patients. The mean aortic bifurcation diameter was 25.5 mm in the SAB group and 13.2 mm in the NAB group. It is noteworthy that, in the NAB group, 21.8% of patients had aortic bifurcations with focal calcific lesions (less than one-third of the circumferential length of the bifurcation) and 48.3% showed extensive calcifications (two-thirds of the circumferential length of the bifurcation), for 29.9% of the patients in the NAB group the aortic bifurcation had a circumferential highly calcific lesion (complete occlusion of the circumferential length of the bifurcation). Technical success was 98.9% in the SAB group and 96.7% in the NAB group (P = .1). The need for iliac component stenting was not significantly different between the groups (SAB 2.0% vs NAB 3.2%; P = .07). The 1-year survival was 97.9% and 96.7% in the SAB and NAB groups, respectively, with no aneurysm-related mortality. The mean follow-up was 18.4 months and 15.3 months in the SAB and NAB groups, respectively. The iliac primary patency was 98.9 % in the SAB group and 96.8% in the NAB group (P = .088), and the primary assisted patency was 100% in both groups. CONCLUSIONS: EVAR with INCRAFT in NABs showed acceptable results. In this multicenter study, the results were comparable in terms of technical success and iliac patency rate between patients with SABs and NABs.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Iliac Artery/surgery , Stents , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/physiopathology , Blood Vessel Prosthesis Implantation/adverse effects , Databases, Factual , Endovascular Procedures/adverse effects , Female , Humans , Iliac Artery/diagnostic imaging , Iliac Artery/physiopathology , Male , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome , Vascular Patency
15.
J Vasc Surg Cases Innov Tech ; 5(4): 576-579, 2019 Dec.
Article in English | MEDLINE | ID: mdl-31867474

ABSTRACT

A 66-year-old man arrived at our emergency department 3 years after an endovascular aneurysm sealing procedure performed at another center. Computed tomography angiography showed distal migration of a Nellix endoprosthesis (Endologix, Irvine, Calif) and a posterior contained rupture. The left kidney was excluded by an occluded iliac-left renal bypass, which was performed at the time of the Nellix implantation because of unintended coverage. A t-Branch (Cook Medical, Bloomington, Ind) was implanted in an emergency, but the delivery caused disruption of the Nellix limb, requiring relining. Target vessels were bridged with VBX stents (W. L. Gore & Associates, Flagstaff, Ariz). The postoperative course was uneventful except for renal function impairment that was restored 2 weeks later.

16.
Ann Vasc Surg ; 57: 266-271, 2019 May.
Article in English | MEDLINE | ID: mdl-30684615

ABSTRACT

BACKGROUND: The aim of this study is to report the Destino-guided branched endovascular aortic repair approach as a valid alternative to catheterization downward branches in complex aortic arch/descending thoracic anatomies. METHODS & RESULTS: A 53-year-old woman with Marfan syndrome underwent a thoracoabdominal aortic aneurysm (TAAA) repair for a type III dissecting aneurysm. A custom repair with an endograft having 3 fenestrations (for renal arteries and superior mesenteric artery) and 1 branch for the celiac trunk was planned. The right axillary artery was chronically occluded; the left subclavian artery (LSA) was aneurysmatic. The catheterization of the celiac trunk branch was demanding but ultimately a bare stent was used as a bridging component between the graft and the target vessel, for spinal cord preconditioning. At the 2-month computed tomography angiography, when planning the relining of the bare metal stent, a 1 cm increase in diameter of the LSA aneurysm was documented and therefore a Destino-guided branched endovascular aortic repair was planned. This approach consists of branch catheterization via femoral access using the Destino steerable guiding sheath inside which, after bending, a smaller Cook Flexor is placed to easily deliver the stent, while maintaining stability. CONCLUSIONS: The Destino-guided branched endovascular aortic repair is a reproducible and effective alternative to the classic catheterization of side branches via brachial/axillary access allowing their completion from a femoral access.


Subject(s)
Aortic Aneurysm, Thoracic/surgery , Aortic Dissection/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Catheterization, Peripheral/instrumentation , Endovascular Procedures/instrumentation , Femoral Artery , Vascular Access Devices , Aortic Dissection/diagnostic imaging , Aortic Dissection/etiology , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/etiology , Aortography/methods , Blood Vessel Prosthesis , Computed Tomography Angiography , Equipment Design , Female , Femoral Artery/diagnostic imaging , Humans , Marfan Syndrome/complications , Marfan Syndrome/diagnosis , Middle Aged , Punctures , Treatment Outcome
17.
J Vasc Surg ; 69(6): 1655-1663, 2019 Jun.
Article in English | MEDLINE | ID: mdl-30497866

ABSTRACT

OBJECTIVE: Staged endovascular treatment of thoracoabdominal aortic aneurysms (TAAAs) with temporary perfusion of the sac through a branch left unstented or a dedicated branch is a strategy intended to reduce the risk of postoperative spinal cord ischemia (SCI). However, potential complications of this approach are aneurysm sac progression between stages, visceral embolism, and occlusion or displacement of components. We here present the "bare branch" technique, a safe adjunct to TAAA repair in terms of interstage complications. METHODS: In the first step, one branch, preferentially the one for the celiac trunk, is stented by a bare stent; in the second step, the bare branch is relined with a covered stent. There were 32 TAAAs (5 type I, 6 type II, 16 type III, 5 type IV) treated by this approach at our center from January 2015 to December 2017 (median follow-up, 13 months [range, 2-24 months]). Data were prospectively collected and retrospectively analyzed. Primary end points were aneurysm sac exclusion and freedom from major adverse events, which included SCI. Secondary end points were freedom from aneurysm growth between the stages and freedom from minor adverse events. RESULTS: Preoperative mean maximum diameter was 68.4 mm; 32 endografts (8 off-the-shelf and 24 custom-made devices) were used. The mean aortic coverage was 364 mm. The mean interval time between the two stages was 10.5 weeks (range, 7-20 weeks). In-hospital mortality was 0%. Type I or type III endoleak rate was 3.2%, whereas one type II endoleak was registered (3.2%). Two patients showed paraparesis, one after the first stage and one after the second stage, both noted at 4/5 on the Tarlov scale, and fully recovered so that the SCI rate was 6.4% with 0% permanent neurologic deficit. Interstage mean maximum diameter was 68.6 mm (P > .05). After the second step, there was an average of 4.7 spinal arteries (standard deviation, 1.4; P < .05) per patient with an increase in visibility and of diameter by 0.7 mm (standard deviation, 0.4 mm). CONCLUSIONS: This is a reproducible adjunct to staged TAAA endovascular repair. The use of a bare branch instead of a branch left completely open has the clear advantage of an easy catheterization in the second step. Furthermore, by having the target vessel stented with a bare stent, the risk of embolism is avoided. In this experience, there was no significant aneurysm sac growth in between the steps. Further comparative studies may determine whether there are different hemodynamic forces with this technique with respect to those already described in the literature.


Subject(s)
Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis Implantation/methods , Endovascular Procedures/methods , Spinal Cord Ischemia/prevention & control , Aged , Aged, 80 and over , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/physiopathology , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Female , Humans , Male , Middle Aged , Progression-Free Survival , Prosthesis Design , Regional Blood Flow , Retrospective Studies , Risk Factors , Spinal Cord Ischemia/diagnosis , Spinal Cord Ischemia/etiology , Spinal Cord Ischemia/physiopathology , Stents , Time Factors
18.
J Cardiovasc Surg (Torino) ; 60(4): 496-500, 2019 08.
Article in English | MEDLINE | ID: mdl-27145124

ABSTRACT

INTRODUCTION: Aortic dissections classification systems have always been an argument of debate. It is well known that none of the described classifications is complete and easy at the same time. While the more used classification is currently the Stanford classification, it is clear that type A and B dissections prognosis can dramatically vary, depending on many different characteristics that they can present. The aim of this study was to propose a new severity score system that could reflect the risk of in hospital mortality of acute aortic dissections. EVIDENCE ACQUISITION: Through a review of the literature, studies describing significant predictors of in hospital mortality of any type of aortic dissection were searched and selected by predefined selection criteria. EVIDENCE SYNTHESIS: Nine studies met the criteria and were finally analyzed. The Odds Ratios of the reported predictors were the basis to the drawing of the score system. Sixteen main in hospital mortality predictors were found, 14 of which described in more than one study. They were combined into a new severity score system that we named VI2TA2 S2C2ORE. CONCLUSIONS: This is a simple risk score that we propose as a first assessment risk-evaluating tool. We look forward to validate it and to describe specific in hospital mortality risk ranges once it will be adopted.


Subject(s)
Aortic Aneurysm/classification , Aortic Dissection/classification , Aortic Dissection/mortality , Hospital Mortality , Acute Disease , Aortic Aneurysm/mortality , Hospitalization , Humans , Odds Ratio , Prognosis , Risk Factors , Severity of Illness Index
19.
J Endovasc Ther ; 25(2): 169-177, 2018 Apr.
Article in English | MEDLINE | ID: mdl-30141378

ABSTRACT

PURPOSE: To assess early and midterm outcomes of iliac branch device (IBD) implantation without an aortic stent-graft for the treatment of isolated common iliac artery aneurysm (CIAA). METHODS: From December 2006 to June 2016, 49 isolated CIAAs in 46 patients were treated solely with an IBD at 7 vascular centers. Five patients were lost to follow-up, leaving 41 male patients (mean age 72.5±7.8 years) for analysis. Mean CIAA diameter was 39.1±10.5 mm (range 25-65). Thirty-two patients (2 with bilateral CIAAs) were treated with a Cook Zenith iliac branch device; 9 patients (1 bilateral) received a Gore Excluder iliac branch endoprosthesis. Primary endpoints were technical success, survival, aneurysm exclusion, device patency, and freedom from reintervention at 1 and 5 years. Freedom from major adverse events and aneurysm shrinkage at 1 year were also assessed. RESULTS: Thirty-day mortality and the IBD occlusion rate were 2.4% and 2.3%, respectively. At a mean follow-up of 40.2±33.9 months, no patient presented buttock claudication, erectile dysfunction, or bowel or spinal cord ischemia. Three patients died within 6 months after the procedure. Estimates of cumulative survival, device patency, and freedom from reintervention were 90.2%, 95.2%, and 95.7%, respectively, at 1 and 5 years. At 1 year, CIAA shrinkage ≥5 mm was recorded in 21 of 38 survivors. No evidence of endoleak, device migration, or disconnection was found on imaging follow-up. CONCLUSION: The use of IBDs without an aortic stent-graft for isolated CIAAs resulted in excellent patency, with low morbidity and mortality. This, in conjunction with no endoleak or migration and a low reintervention rate, supports the use of isolated IBDs as a stable and durable means of endovascular reconstruction in cases with suitable anatomy. Longer follow-up and a larger cohort are needed to validate these results.


Subject(s)
Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Iliac Aneurysm/surgery , Stents , Aged , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , Humans , Iliac Aneurysm/diagnostic imaging , Iliac Aneurysm/mortality , Iliac Aneurysm/physiopathology , Italy , Male , Postoperative Complications/mortality , Postoperative Complications/therapy , Progression-Free Survival , Prosthesis Design , Registries , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Vascular Patency
20.
Ann Vasc Surg ; 46: 285-298, 2018 Jan.
Article in English | MEDLINE | ID: mdl-28739452

ABSTRACT

BACKGROUND: Large gutters after chimney procedures are one of the main causes of type I endoleak (EL-I). This study aims to evaluate a new tailored planning named "Over-SIRIX," based on Osirix Imaging Software, to choose the correct main graft oversizing in order to minimize EL-I incidence. METHODS: From 2008 to 2015, 34 patients were treated with parallel grafts for aortic arch diseases at our institution. The study included 22 patients with single stent and antegrade flow configuration; they were divided into 2 groups (PRE- and POST-"Over-SIRIX"). "Over-SIRIX" was carried out in the retrospective group (PRE-"Over-SIRIX"), and it was used to plan the endovascular procedure in the prospective group (POST-"Over-SIRIX"). Through the multiplanar reconstruction (MPR) of the preoperative computed tomography angiography (CTA), the proximal neck of the chimney grafts was studied. Stent and endograft configurations were drawn in order to minimize the "gutters." To obtain the ideal main graft sizing (I-Size), a formula was used by adding the custom sizing (C-Size) to the disease oversizing (D-Over). The same MPR imaging was evaluated on postoperative CTA to study gutters area and presence of EL-I. RESULTS: The mean I-Size was 41.67 mm that was equivalent to an ideal oversizing of 19.3% (range 10-28%). The gutters area decreased from 7.3 to 1.7 mm2 (PRE/POST) and EL-I rate from 28.5% to 0% (PRE/POST). Gutters area bigger than 7.5 mm2 and planning made without "Over-SIRIX" were significantly associated (P < 0.05) to EL-I. CONCLUSIONS: "Over-SIRIX" appears to be a feasible method to customize planning during chimney technique, reducing the risk of EL-I which is significantly related to the presence and size of the gutters.


Subject(s)
Aorta, Thoracic/surgery , Aortic Diseases/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Prosthesis Design , Stents , Aged , Aged, 80 and over , Aorta, Thoracic/diagnostic imaging , Aortic Diseases/diagnostic imaging , Aortic Diseases/mortality , Aortography/methods , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Computed Tomography Angiography , Endoleak/etiology , Endoleak/prevention & control , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Feasibility Studies , Female , Humans , Male , Observer Variation , Predictive Value of Tests , Reproducibility of Results , Rome , Treatment Outcome
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