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1.
J Vasc Surg ; 2024 Mar 25.
Article in English | MEDLINE | ID: mdl-38537877

ABSTRACT

OBJECTIVE: The aim of this multicenter national study was to compare the outcomes of primary open surgery by aorto-bifemoral bypass (ABFB) with those performed after a failed endovascular treatment (EVT) by kissing stent technique for complex aortoiliac occlusive disease (AIOD) lesions (TransAtlantic Inter-Society Consensus [TASC] II C and D). METHODS: All consecutive ABFB cases carried out at 12 vascular surgery centers between 2016 and 2021 were retrospectively collected and analyzed. Data included patients' baseline demographics and clinical characteristics, procedural details, perioperative outcomes, and follow-up results (survival, patency, amputation). The study cohort was divided into two groups based on indications for ABFB: primary treatment vs secondary treatment after EVT failure. RESULTS: Overall, 329 patients underwent ABFB during the study period (71% males; mean age, 64 years), of which 285 were primary treatment and 44 were after prior EVT. At baseline, no significant differences were found between study groups in demographics and clinical characteristics. TASC C and D lesions were similarly represented in the study groups (TASC C: 22% vs 78%; TASC D: 16% vs 84%). No major differences were found between study groups in terms of procedural details, early mortality, and perioperative complications. At 5 years, primary patency rates were significantly higher for primary ABFB (88%; 95% confidence interval [CI], 93.2%-84%) as compared with ABFB after prior EVT (69%; 95% CI 84.9%-55%; log rank P value < .001); however, the 5-year rates of secondary patency (100% vs 95%; 95% CI, 100%-86%) and limb salvage (97%; 95% CI, 99%-96 vs 97%; 95% CI, 100%-94%) were similar between study groups. CONCLUSIONS: Surgical treatment of TASC C/D AIOD with ABFB seems to be equally safe and effective when performed after prior EVT, although primary ABFB seemed to have higher primary patency rates. Despite the need for more frequent reinterventions, secondary patency and limb salvage rates were similar. However, future large prospective trials are required to confirm these findings.

2.
Ann Surg ; 2024 Feb 07.
Article in English | MEDLINE | ID: mdl-38323417

ABSTRACT

OBJECTIVE: To analyze the outcomes of urgent/emergent endovascular aortic repair of patients with free/contained ruptured thoracoabdominal aortic aneurysms (rTAAA). BACKGROUND: Endovascular repair of rTAAA has been scarcely described in emergent setting. METHODS: An international multicenter retrospective observational study (ClinicalTrials.govID:NCT05956873) from January-2015 to January-2023 in 6 European and 1 United States Vascular Surgery Centers. Primary end-points were technical success, 30-day and/or in-hospital mortality and follow-up survival. RESULTS: A total of 100 rTAAA patients were included (75 male; mean age 73 y). All patients (86 contained and 14 free ruptures) were symptomatic and treated within 24-hours from diagnosis: multi-branched off-the-shelf devices (Zenith t-branch,Cook Medical Inc.Bjaeverskov,Denmark) in 88 patients, physician-modified endografts in 8, patient-specific device or parallel grafts in two patients each. Primary technical success was achieved in 89 patients and 30-day and/or in-hospital mortality was 24%. Major adverse events (MAEs) occurred in 34% of patients (permanent dialysis and paraplegia in 4 and 8 patients, respectively). No statistical differences were detected in mortality rates between free and contained ruptured patients (43%vs.21%; P =0.075). Multivariate analysis revealed contained rupture favoring technical success (Odd-Ratio10.1;95%Confidence-Interval:3.0-33.6; P =<0.001). MAEs (OR9.4;95%C-I:2.8-30.5; P =<0.001) and pulmonary complications (OR11.3;95%CI:3.0-41.5; P =<0.001) were independent risk factors for 30-day and/or in-hospital mortality. Median follow-up time was 13 months (interquartile range 5-24); 1-year survival rate was 65%. Aneurysm diameter>80 mm (Hazard-Ratio:2.0;95%CI:1.0-30.5; P =0.037), technical failure (HR:2.6;95%CI:1.1-6.5; P =0.045) and pulmonary complications (HR:3.0;95%CI:1.2-7.9; P =0.021) were independent risk factors for follow-up mortality. CONCLUSION: Endovascular repair of rTAAA shows high technical success; the presence of free rupture alone appear not to correlate with early mortality. Effective prevention/management of post-operative complications is crucial for survival.

3.
J Cardiovasc Surg (Torino) ; 65(1): 49-63, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38037721

ABSTRACT

The objective of these Guidelines is to provide recommendations for the classification, indication, treatment and management of patients suffering from aneurysmal pathology of the visceral and renal arteries. The methodology applied was the GRADE-SIGN version, and followed the instructions of the AGREE quality of reporting checklist. Clinical questions, structured according to the PICO (Population, Intervention, Comparator, Outcome) model, were formulated, and systematic literature reviews were carried out according to them. Selected articles were evaluated through specific methodological checklists. Considered Judgments were compiled for each clinical question in which the characteristics of the body of available evidence were evaluated in order to establish recommendations. Overall, 79 clinical practice recommendations were proposed. Indications for treatment and therapeutic options were discussed for each arterial district, as well as follow-up and medical management, in both candidate patients for conservative therapy and patients who underwent treatment. The recommendations provided by these guidelines simplify and improve decision-making processes and diagnostic-therapeutic pathways of patients with visceral and renal arteries aneurysms. Their widespread use is recommended.


Subject(s)
Aneurysm , Embolization, Therapeutic , Humans , Renal Artery/diagnostic imaging , Radiology, Interventional , Aneurysm/diagnostic imaging , Aneurysm/surgery , Embolization, Therapeutic/adverse effects , Italy
4.
Int Angiol ; 42(6): 520-527, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37943290

ABSTRACT

BACKGROUND: The aim of the study was to evaluate the correlation between frailty, measured by the Five-Factor Modified Frailty Index (mFI-5) and mortality and all major adverse events (MAE) in patients who underwent proximal abdominal aortic aneurysm (p-AAA) open surgery (OS). METHODS: Data of all elective patients submitted to p-AAA OS from 2010 to 2021 were recorded. Primary endpoints were 30-day mortality and mid-term survival and secondary endpoints included postoperative acute kidney injury (AKI), freedom from aortic reintervention and any MAE. The impact of frailty was assessed by univariate and multivariate analysis; mid-term overall survival were estimated using Kaplan-Meier method (log-rank test). RESULTS: Two-hundred twenty-one patients (197 male, 24 female; aged 72.2±7.4) were included. Thirty-seven (16.4%) were octogenarians (>80 years). The mFI-5 was assessed in the entire group: mean mFI-5 was 0.29±0.12. One-hundred patients (100/221, 45.25%, 91:9 male-to-female ratio) were defined "frail" considering the mFI-5 cut-off >0.25. At univariate analysis a correlation was found between mFI-5>0.25 and mid-term mortality (Pearson correlation [r] 0.280, P<0.001) and AKI (r=0.146, P=0.030). No correlation with 30-day mortality was found (P not significant). At multivariate analysis mFI-5>0.25 increased the risk for midterm mortality (odds ratio 3.32, P=0.021) and postoperative AKI (OR 2.09, P<0.001). The effect of mFI-5>0.25 on mid-term mortality persisted after adjustment for age (P<0.001). Survival was estimated with Kaplan-Meyer method (mean follow-up of 52.7 months, 95% CI: 48.6-56.8); 68 (30.7%) deaths were recorded: 23 among non-frail patients (19.0%) and 45 among frail patients (45/100, 45%, P<0.001). CONCLUSIONS: These findings suggest that mFI-5 is a tool capable to identify "frail" patients, who appear to be at increased risk of postoperative AKI and mid-term mortality, but not 30-day mortality. Five-factor modified Frailty Index assessment is simple, fast and can be widely applied in surgical practice to perform appropriate risk stratifications.


Subject(s)
Acute Kidney Injury , Aortic Aneurysm, Abdominal , Frailty , Aged, 80 and over , Humans , Male , Female , Frailty/complications , Frailty/diagnosis , Risk Factors , Risk Assessment , Postoperative Complications/etiology , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Abdominal/complications , Retrospective Studies , Acute Kidney Injury/complications
5.
Int Angiol ; 42(5): 402-411, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37943291

ABSTRACT

BACKGROUND: The aim of this study was to assess perioperative and late performance of a silver acetate and triclosan impregnated antimicrobial vascular graft (Intergard Synergy, Intervascular SAS, La Ciotat, France) during open surgical repair of abdominal aortic aneurysms (AAA), and to compare it with standard polyester grafts ones. METHODS: This retrospective single-centre study (STAGER Study, clinicaltrials.gov: NCT04557254) included patients undergone non-infectious AAA surgical repair between 2012 and 2019, divided into two groups according to the implanted aortic prosthesis: standard polyester graft (PolyG) and silver-triclosan graft (SynG). Early primary endpoints were 30-day mortality, major adverse events (MAEs), and reintervention rates; late primary endpoints were overall and aortic-related survival, reintervention-free survival, and graft infection rate at a mean follow-up (FU) of 49.4±26.8 months. RESULTS: Five hundred forty-seven patients were included [PolyG 49%, and SynG 51%]. Both groups were substantially homogeneous in risk factors and demographics. Two patients died within 30 days. In-hospital MAE rate [PolyG 14.2% vs. SynG 10.7%; P=.248] and 30-day reintervention rate were not significantly different [PolyG 2.6% vs. SynG 1.4%; P=.374]. At 5 years, overall survival in the PolyG and SynG groups were 85% and 84%, respectively. Reintervention-free survival was 82% for both groups. Aortic-related survival was 95% and 96%, respectively. Graft infection was observed in 8 (3.3%) PolyG patients and 5 (1.8%) SynG patients. CONCLUSIONS: Silver acetate and triclosan impregnated grafts demonstrated good early and mid-term results, being considered safe and durable for AAA open repair. Similar graft infection and related death rates were observed compared to polyester standard grafts, supporting non-superiority of one graft over the other.


Subject(s)
Anti-Infective Agents , Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Triclosan , Humans , Triclosan/adverse effects , Blood Vessel Prosthesis/adverse effects , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/methods , Retrospective Studies , Postoperative Complications/etiology , Aortic Aneurysm, Abdominal/surgery , Polyesters , Treatment Outcome , Risk Factors
6.
Ann Surg ; 278(4): 568-577, 2023 10 01.
Article in English | MEDLINE | ID: mdl-37395613

ABSTRACT

OBJECTIVE: To describe outcomes after elective and non-elective fenestrated-branched endovascular aortic repair (FB-EVAR) for thoracoabdominal aortic aneurysms (TAAAs). BACKGROUND: FB-EVAR has been increasingly utilized to treat TAAAs; however, outcomes after non-elective versus elective repair are not well described. METHODS: Clinical data of consecutive patients undergoing FB-EVAR for TAAAs at 24 centers (2006-2021) were reviewed. Endpoints including early mortality and major adverse events (MAEs), all-cause mortality, and aortic-related mortality (ARM), were analyzed and compared in patients who had non-elective versus elective repair. RESULTS: A total of 2603 patients (69% males; mean age 72±10 year old) underwent FB-EVAR for TAAAs. Elective repair was performed in 2187 patients (84%) and non-elective repair in 416 patients [16%; 268 (64%) symptomatic, 148 (36%) ruptured]. Non-elective FB-EVAR was associated with higher early mortality (17% vs 5%, P <0.001) and rates of MAEs (34% vs 20%, P <0.001). Median follow-up was 15 months (interquartile range, 7-37 months). Survival and cumulative incidence of ARM at 3 years were both lower for non-elective versus elective patients (50±4% vs 70±1% and 21±3% vs 7±1%, P <0.001). On multivariable analysis, non-elective repair was associated with increased risk of all-cause mortality (hazard ratio, 1.92; 95% CI] 1.50-2.44; P <0.001) and ARM (hazard ratio, 2.43; 95% CI, 1.63-3.62; P <0.001). CONCLUSIONS: Non-elective FB-EVAR of symptomatic or ruptured TAAAs is feasible, but carries higher incidence of early MAEs and increased all-cause mortality and ARM than elective repair. Long-term follow-up is warranted to justify the treatment.


Subject(s)
Aortic Aneurysm, Abdominal , Aortic Aneurysm, Thoracic , Aortic Aneurysm, Thoracoabdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Male , Humans , Middle Aged , Aged , Aged, 80 and over , Female , Aortic Aneurysm, Thoracic/surgery , Aortic Aneurysm, Abdominal/surgery , Endovascular Aneurysm Repair , Blood Vessel Prosthesis Implantation/adverse effects , Treatment Outcome , Risk Factors , Endovascular Procedures/adverse effects , Time Factors , Retrospective Studies , Blood Vessel Prosthesis
7.
Expert Rev Med Devices ; 20(9): 715-720, 2023.
Article in English | MEDLINE | ID: mdl-37486180

ABSTRACT

INTRODUCTION: Radial access is the standard of care for nearly all cardiac catheterization procedures. It improves patient satisfaction, reduces the length of stay, and is associated with fewer complications. However, few devices and tools are available for the treatment of peripheral arterial disease via a transradial approach (TRA). The S.M.A.R.T. RADIANZ Vascular Stent System is among the RADIANZ suite of products, which is aimed at expanding the portfolio of devices to treat peripheral arterial disease. AREAS COVERED: In this Expert review, the following areas will be covered: (1) Current Landscape of peripheral vascular intervention (PVI) using TRA (2) Detailed description of the S.M.A.R.T. RADIANZ Vascular Stent System. (3) Ongoing clinical trials to evaluate safety of this approach. (4) Future directions and current regulatory status. EXPERT OPINION: TRA for PVI is a promising approach. It holds the possibility of substantially improving the care of patients with peripheral arterial disease (PAD). Numerous challenges must be overcome to realize the full potential of a radial-to-peripheral (RTP) approach. The length of devices and the small sheath size are the main constraints of this approach. The results of the ongoing RADIANCY trial will demonstrate the safety, in selected patients, of the RADIANZ suite of products.


Subject(s)
Catheterization, Peripheral , Endovascular Procedures , Peripheral Arterial Disease , Humans , Treatment Outcome , Radial Artery/surgery , Catheterization, Peripheral/methods , Peripheral Arterial Disease/surgery , Stents
8.
J Clin Med ; 12(9)2023 Apr 29.
Article in English | MEDLINE | ID: mdl-37176634

ABSTRACT

BACKGROUND: In the last decade, advances in surgical techniques, and the introduction of adjuncts for organ protection, have modified the approach for thoracoabdominal aortic aneurysm (TAAA) surgical repair. The aim of this study is to determine whether the contemporary approach influenced the outcomes. METHODS: From 1989 to 2022, patients who had received elective open surgical repair (OSR) for TAAA at our institution were retrospectively analyzed. This series has been divided in two groups: Group 1 (1989-2009), and Group 2 (2010-2022). Patients included in Group 1 were those treated with a selective use of adjuncts, and Group 2 included patients treated with the systematic use of adjuncts. RESULTS: A total of 1107 patients were treated (Group 1: 455; Group 2: 652). The surgical management was significantly different between the two groups. The in-hospital mortality was significantly different between the two groups (Group 1: 13.4%, Group 2: 8.1%; p 0.004), as was the rate of permanent spinal cord ischemia (Group 1: 11.9%, Group 2: 7.8%; p 0.023). Renal and respiratory failure were reduced in Group 2, but not significantly. CONCLUSIONS: The use of the adjuncts enabled the achievement of improvement in mortality and SCI prevention in TAAA OSR. Although a refined surgical technique, mortality and morbidity are still noteworthy in this complex aortic field.

9.
J Thorac Cardiovasc Surg ; 165(2): 569-579.e5, 2023 02.
Article in English | MEDLINE | ID: mdl-33820636

ABSTRACT

OBJECTIVE: The objective of this study was to compare the efficacy of renal perfusion with Custodiol (Dr Franz-Kohler Chemie GmbH, Bensheim, Germany) versus enriched Ringer's solution for renal protection in patients undergoing open thoracoabdominal aortic aneurysm (TAAA) repair. METHODS: Ninety consecutive patients scheduled for elective open TAAA repair were enrolled between 2015 and 2017 in a single-center, phase IV, prospective, parallel, randomized, double-blind trial (the CUstodiol versus RInger: whaT Is the Best Agent [CURITIBA] trial), and randomized to renal arteries perfusion with 4°C Custodiol (Dr Franz-Kohler Chemie GmbH, Bensheim, Germany; n = 45) or 4°C lactated Ringer's solution (n = 45). The incidence of acute kidney injury (AKI) in patients undergoing TAAA open surgery using Custodiol renal perfusion versus an enriched Ringer's solution was the primary end point. RESULTS: Ninety patients completed the study (45 patients in each group). The incidence of postoperative AKI was significantly lower in the Custodiol group (48.9% vs 75.6%; P = .02). In the multivariable model, only the use of Custodiol solution resulted as protective from the occurrence of any AKI (odds ratio, 0.230; 95% confidence interval, 0.086-0.614; P = .003), whereas TAAA type II extent was associated with the development of severe AKI (odds ratio, 4.277; 95% confidence interval, 1.239-14.762; P = .02). At 1-year follow-up, serum creatinine was not significantly different from the preoperative values in both groups. CONCLUSIONS: The use of Custodiol during open TAAA repair was safe and resulted in significantly lower rates of postoperative AKI compared with Ringer's solution. These findings support safety and efficacy of Custodiol in this specific setting, which is currently off-label.


Subject(s)
Acute Kidney Injury , Aortic Aneurysm, Thoracic , Humans , Ringer's Solution , Histidine , Tryptophan , Prospective Studies , Acute Kidney Injury/epidemiology , Acute Kidney Injury/etiology , Acute Kidney Injury/prevention & control , Perfusion/adverse effects , Perfusion/methods , Aortic Aneurysm, Thoracic/surgery , Aortic Aneurysm, Thoracic/complications , Treatment Outcome , Retrospective Studies
10.
J Endovasc Ther ; 30(2): 281-288, 2023 04.
Article in English | MEDLINE | ID: mdl-35236159

ABSTRACT

PURPOSE: The aim of this study is to report an Italian multicenter experience analyzing the incidence and the risk factors associated with spinal cord ischemia (SCI) in a large cohort of thoracoabdominal aortic aneurysms (TAAAs) treated by fenestrated-branched endovascular aneurysm repair (F-/B-EVAR). MATERIALS AND METHODS: All consecutive patients undergoing F-/B-EVAR in 4 Italian university centers between 2008 and 2019 were prospectively recorded and retrospectively analyzed. Spinal cord ischemia, 30 day/in-hospital adverse events, and mortality were assessed as early outcomes. Risk factors for SCI were determined by multivariable analysis. RESULTS: A total of 351 patients received F-/B-EVAR for a TAAA. Twenty-eight (8.0%) patients died within 30 postoperative days or during the hospitalization. Regarding SCI, 47 patients (13.4%) developed neurological symptoms related to spinal cord impaired perfusion. Among them, 17 (4.8%) had a major permanent impairment. The multivariable analysis identified that SCI was associated with Crawford extent I to III (odds ratio [OR]: 20.90, p=0.004, 95% confidence interval [CI]=2.69-162.57), and with endovascular procedures performed for ruptured TAAA (OR: 5.74, p=0.010, 95% CI=1.53-21.57). Spinal cord ischemia was also significantly associated with a grade 3 bleeding during the visceral stage (OR: 4.34, p=0.005, 95% CI=1.55-12.16) and a grade 2 renal insufficiency at 30 days (OR: 7.45, p=0.002, 95% CI=2.12-26.18). CONCLUSION: The present study indicates that SCI is still an open issue after extent I to III TAAA endovascular repair, while its incidence in extent IV TAAA and pararenal/juxtarenal aneurysms is rare. Thoracoabdominal aortic aneurysms extension, urgent TAAA repair for rupture, severe bleeding, and 30 day renal insufficiency have been identified as significant risk factors for SCI. In the presence of such factors, adjunctive strategies may be considered to reduce SCI rates, while in low-risk patients invasive or potentially-risky maneuvers might not be justified.


Subject(s)
Aortic Aneurysm, Abdominal , Aortic Aneurysm, Thoracic , Aortic Aneurysm, Thoracoabdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Renal Insufficiency , Spinal Cord Ischemia , Humans , Blood Vessel Prosthesis/adverse effects , Endovascular Aneurysm Repair , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/surgery , Retrospective Studies , Treatment Outcome , Spinal Cord Ischemia/diagnostic imaging , Spinal Cord Ischemia/epidemiology , Spinal Cord Ischemia/etiology , Risk Factors , Renal Insufficiency/complications , Renal Insufficiency/surgery , Registries
11.
Aorta (Stamford) ; 10(4): 162-168, 2022 Aug.
Article in English | MEDLINE | ID: mdl-36521807

ABSTRACT

Open conversion of thoracoabdominal aortic (TAA) disease after failed attempts of endovascular treatment is increasingly required. The main causes are endoleak, endograft failure, infection, disease progression, or persistent false lumen perfusion in dissected aortas. Mortality and morbidity rates are high, higher than after standard TAA open repair. Therefore, this surgery should be performed only in dedicated centers by experienced teams. Specific perioperative organ protection protocols, as well as surgical techniques, are crucial to guarantee acceptable results.

12.
Cir Cir ; 90(5): 713-716, 2022.
Article in English | MEDLINE | ID: mdl-36327486

ABSTRACT

The skills development to address vascular trauma by general surgeons is important in hospitals in countries with a lack of vascular surgeons, so we agree the implementation of training programs in vascular surgery basic techniques for general surgeons. In Peru, through an exploratory survey, 43 public hospitals have at least one vascular surgeon, of which 20 are located in Metropolitan Lima, and 14 of the 26 regions of Peru have at least one public institution with vascular surgery capabilities. We recommend the incorporation of the transient arterial shunt technique as an alternative to vascular anastomosis due to its security and feasibility for general surgeons training programs.


Es importante el desarrollo de habilidades por los cirujanos generales para abordar el trauma vascular en los hospitales de países con escaso número de cirujanos vasculares, por lo que coincidimos con la implementación de programas de capacitación en técnicas básicas de cirugía vascular para los cirujanos generales. En Perú, a través de una encuesta exploratoria, encontramos que 43 hospitales públicos cuentan con al menos un cirujano vascular, de los cuales 20 están ubicados en Lima Metropolitana, y 14 de las 26 regiones del Perú cuentan con al menos una institución pública con capacidades en cirugía vascular. Recomendamos la incorporación de la técnica de derivación arterial transitoria como alternativa a la anastomosis vascular debido a su seguridad y factibilidad para los programas de formación de cirujanos generales.


Subject(s)
Surgeons , Humans , Surgeons/education , Peru , Retrospective Studies
13.
Circulation ; 146(21): 1564-1576, 2022 11 22.
Article in English | MEDLINE | ID: mdl-36254728

ABSTRACT

BACKGROUND: A clear patency benefit of a drug-eluting stent (DES) over bare metal stents (BMSs) for treating peripheral artery disease of the femoropopliteal segment has not been definitively demonstrated. The EMINENT study (Trial Comparing Eluvia Versus Bare Metal Stent in Treatment of Superficial Femoral and/or Proximal Popliteal Artery) was designed to evaluate the patency of the Eluvia DES (Boston Scientific, Marlborough, MA), a polymer-coated paclitaxel-eluting stent, compared with BMSs for the treatment of femoropopliteal artery lesions. METHODS: EMINENT is a prospective, randomized, controlled, multicenter European study with blinded participants and outcome assessment. Patients with symptomatic peripheral artery disease (Rutherford category 2, 3, or 4) of the native superficial femoral artery or proximal popliteal artery with stenosis ≥70%, vessel diameter of 4 to 6 mm, and total lesion length of 30 to 210 mm were randomly assigned 2:1 to treatment with DES or BMS. The primary effectiveness outcome was primary patency at 12 months, defined as independent core laboratory-assessed duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically driven target lesion revascularization or surgical bypass of the target lesion. Primary sustained clinical improvement was a secondary outcome defined as a decrease in Rutherford classification of ≥1 categories compared with baseline without a repeat target lesion revascularization. Health-related quality of life and walking function were assessed. RESULTS: A total of 775 patients were randomly assigned to treatment with DES (n=508) or commercially available BMSs (n=267). Baseline clinical, demographic, and lesion characteristics were similar between the study groups. Mean lesion length was 75.6±50.3 and 72.2±47.0 mm in the DES and BMS groups, respectively. The 12-month incidence of primary patency for DES treatment (83.2% [337 of 405]) was significantly greater than for BMS (74.3% [165 of 222]; P<0.01). Incidence of primary sustained clinical improvement was greater among patients treated with the DES than among those who received a BMS (83.0% versus 76.6%; P=0.045). The health-related quality of life dimensions of mobility and pain/discomfort improved for the majority of patients in both groups (for 66.4% and 53.6% of DES-treated and for 64.2% and 58.1% of BMS-treated patients, respectively) but did not differ significantly. At 12 months, no statistical difference was observed in all-cause mortality between patients treated with the DES or BMS (2.7% [13 of 474] versus 1.1% [3 of 263]; relative risk, 2.4 [95% CI, 0.69-8.36]; P=0.15). CONCLUSIONS: By demonstrating superior 1-year primary patency, the results of the EMINENT randomized study support the benefit of using a polymer-based paclitaxel-eluting stent as a first-line stent-based intervention for patients with symptomatic peripheral artery disease attributable to femoropopliteal lesions. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02921230.


Subject(s)
Drug-Eluting Stents , Peripheral Arterial Disease , Humans , Prospective Studies , Quality of Life , Vascular Patency , Popliteal Artery/diagnostic imaging , Popliteal Artery/pathology , Femoral Artery/pathology , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/therapy , Peripheral Arterial Disease/pathology , Stents , Paclitaxel , Polymers , Treatment Outcome
14.
Int Angiol ; 41(5): 444-453, 2022 Oct.
Article in English | MEDLINE | ID: mdl-35913078

ABSTRACT

BACKGROUND: To face the "first wave" of the pandemic (01/03/2020-15/05/2020), Lombardy's healthcare system was reorganized according to the "Hub-and-Spoke" model, and deferrable inpatient and outpatient activities were suspended. The limitations imposed by COVID-19, associated with patients' fear of presenting to medical attention, may have led to a delay in diagnosis and treatment of time-dependent pathologies. Our multicenter retrospective cohort study aims at analyzing the impact on COVID-negative patients of the shift of medical resources in Lombardy, the Italian epicenter of the pandemic. METHODS: Inclusion criteria were an age ≥18, COVID-negative condition, and referral to IRCCS Istituto Clinico Humanitas - Rozzano, Milan (Spoke Center) or IRCCS Ospedale San Raffaele - Milan (Hub Center) for acute vascular diseases requiring urgent treatment. SARS-CoV-2 infection, either on admission or during hospitalization, was the exclusion criterion. Data of the "first wave" were compared with the corresponding months of 2019, to highlight differences in vascular pathologies' case rates, clinical presentation, treatment type and post-treatment outcomes (mortality, rate of adverse events, primary and secondary clinical success and of amputation). RESULTS: Two hundred and two patients were treated for acute vascular diseases, 52 in 2019, 150 in 2020 (P<0.001). A later presentation to medical attention (4.3 versus 5.9 days after symptoms onset, P=0.03) and an increased need for urgent treatment for peripheral arterial disease (P=0.04) differentiated 2020. A higher number of peripheral arterial disease patients underwent major amputations (P=0.38). Access to post-surgical rehabilitation programs was restricted (P<0.001). CONCLUSIONS: During the first wave of COVID-19 pandemic, in the face of a radical health care rearrangement, no increase in mortality nor in post-operative adverse event rate was registered. Anyway, urgent hospitalizations for vascular disease increased, more specifically for peripheral ischemia, in which late presentation may have influenced an increase in amputation rate.


Subject(s)
COVID-19 , Peripheral Arterial Disease , Humans , Pandemics , COVID-19/epidemiology , SARS-CoV-2 , Retrospective Studies , Italy/epidemiology
15.
J Vasc Surg ; 76(2): 546-555.e3, 2022 08.
Article in English | MEDLINE | ID: mdl-35470015

ABSTRACT

OBJECTIVE: The optimal revascularization modality following complete resection of aortic graft infection (AGI) without enteric involvement remains unclear. The purpose of this investigation is to determine the revascularization approach associated with the lowest morbidity and mortality using real-world data in patients undergoing complete excision of AGI. METHODS: A retrospective, multi-institutional study of AGI from 2002 to 2014 was performed using a standardized database. Baseline demographics, comorbidities, and perioperative variables were recorded. The primary outcome was infection-free survival. Descriptive statistics, Kaplan-Meier survival analysis, and univariate and multivariable analyses were performed. RESULTS: A total of 241 patients at 34 institutions from seven countries presented with AGI during the study period (median age, 68 years; 75% male). The initial aortic procedures that resulted in AGI were 172 surgical grafts (71%), 66 endografts (27%), and three unknown (2%). Of the patients, 172 (71%) underwent complete excision of infected aortic graft material followed by in situ (in-line) bypass (ISB), including antibiotic-treated prosthetic graft (35%), autogenous femoral vein (neo-aortoiliac surgery) (24%), and cryopreserved allograft (41%). Sixty-nine patients (29%) underwent extra-anatomic bypass (EAB). Overall median Kaplan-Meier estimated survival was 5.8 years. Perioperative mortality was 16%. When stratified by ISB vs EAB, there was a significant difference in Kaplan-Meier estimated infection-free survival (2910 days; interquartile range, 391-3771 days vs 180 days; interquartile range, 27-3750 days; P < .001). There were otherwise no significant differences in presentation, comorbidities, or perioperative variables. Multivariable Cox regression showed lower infection-free survival among patients with EAB (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.6-3.6; P < .001), polymicrobial infection (HR, 2.2; 95% CI, 1.4-3.5; P = .001), methicillin-resistant Staphylococcus aureus infection (HR, 1.7; 95% CI, 1.1-2.7; P = .02), as well as the protective effect of omental/muscle flap coverage (HR, 0.59; 95% CI, 0.37-0.92; P = .02). CONCLUSIONS: After complete resection of AGI, perioperative mortality is 16% and median overall survival is 5.8 years. EAB is associated with nearly a two and one-half-fold higher reinfection/mortality compared with ISB. Omental and/or muscle flap coverage of the repair appear protective.


Subject(s)
Blood Vessel Prosthesis Implantation , Coinfection , Methicillin-Resistant Staphylococcus aureus , Prosthesis-Related Infections , Aged , Blood Vessel Prosthesis/adverse effects , Coinfection/surgery , Female , Humans , Male , Prosthesis-Related Infections/diagnosis , Prosthesis-Related Infections/surgery , Reoperation , Retrospective Studies , Risk Factors , Treatment Outcome
17.
J Cardiovasc Surg (Torino) ; 63(2): 131-136, 2022 Apr.
Article in English | MEDLINE | ID: mdl-35238521

ABSTRACT

Endovascular treatment is the current standard of care for complicated acute and subacute type B aortic dissection. Closure of the primary entry tear with thoracic endovascular aneurysm repair (TEVAR) is often insufficient to induce complete false lumen thrombosis and a positive aortic remodeling. Moreover, TEVAR does not solve all the cases of malperfusion. The Provisional ExTension to Induce COmplete ATtachment (PETTICOAT) technique (deploying self-expandable bare metal stents in the true lumen in addition to TEVAR) can re-expand the true lumen, stabilize the lamella and promote aortic remodeling, but it does not recreate a single-lumen aorta and long-term aneurysmal degeneration of the aorta is frequent. Endovascular treatment by means of TEVAR + PETTICOAT does not recreate a single-lumen aorta so long-term aneurysmal degeneration of the aorta is frequent. The stent-assisted, balloon-induced intimal disruption and relamination of aortic dissection (STABILISE) technique may help to this purpose disrupting the intimal lamella and creating a relaminated uni-luminal aorta.


Subject(s)
Aortic Aneurysm, Abdominal , Aortic Aneurysm, Thoracic , Aortic Dissection , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Aortic Dissection/complications , Aortic Dissection/diagnostic imaging , Aortic Dissection/surgery , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/methods , Endovascular Procedures/adverse effects , Endovascular Procedures/methods , Humans , Retrospective Studies , Stents , Treatment Outcome
18.
JACC Cardiovasc Interv ; 15(6): 618-626, 2022 03 28.
Article in English | MEDLINE | ID: mdl-35219622

ABSTRACT

OBJECTIVES: The aim of the study was to assess 24-month efficacy and safety of a novel drug-eluting stent (DES) for femoropopliteal interventions with an innovative stent design and abluminal reservoir technology releasing the amphilimus formulation (sirolimus plus fatty acid) for efficient drug transfer and optimized release kinetics. BACKGROUND: DES releasing paclitaxel exhibited good patency rates after femoropopliteal interventions. No benefit has been reported when sirolimus or everolimus were used for antiproliferative stent coating. METHODS: Within a multicenter, first-in-man, single-arm study, 100 patients with symptomatic femoropopliteal disease (Rutherford category 2-4, mean lesion length 5.8 ± 3.9 cm, 35.0% total occlusions) were treated with the NiTiDES stent (Alvimedica). Two-year follow-up included assessment of primary patency (defined as absence of clinically driven target lesion revascularization or binary restenosis with a peak systolic velocity ratio >2.4 by duplex ultrasound), safety, functional, and clinical outcomes. RESULTS: At 24 months, Kaplan-Meier estimates of primary patency and freedom from clinically driven target lesion revascularization were 83.4% (95% CI: 73.9%-89.6%) and 93.1% (95% CI: 85.3%-96.9%), respectively. Over the study period, 3 deaths were reported with no major limb amputation. Functional and clinical benefits were sustained, as 82.1% of patients fell into Rutherford category 0 or 1 at 24 months, which was associated with preserved improvements in all walking disability questionnaire scores. CONCLUSIONS: The 2-year results of the ILLUMINA (Innovative siroLimus seLf expanding drUg-eluting stent for the treatMent of perIpheral disease: evaluation of safety aNd efficAcy) study demonstrate a sustained treatment benefit with a novel sirolimus-eluting stent that also compares favorably to other femoropopliteal intervention trials. Head-to-head comparisons of NiTiDES with a paclitaxel-based DES are warranted. (The ILLUMINA Study [ILLUMINA]; NCT03510676).


Subject(s)
Cardiovascular Agents , Drug-Eluting Stents , Peripheral Arterial Disease , Cardiovascular Agents/adverse effects , Femoral Artery/diagnostic imaging , Humans , Paclitaxel/adverse effects , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/therapy , Popliteal Artery/diagnostic imaging , Sirolimus/adverse effects , Stents , Treatment Outcome , Vascular Patency
19.
Int Angiol ; 41(2): 128-135, 2022 Apr.
Article in English | MEDLINE | ID: mdl-35112827

ABSTRACT

BACKGROUND: Postoperative pain after thoracoabdominal (TAAA) or thoracic (TAA) aortic aneurysm open surgical repair may be debilitating and induce limitations in mobilization resulting in a longer length of stay, higher rate of pulmonary adverse events, readmissions, and a higher risk of mortality. Commonly employed analgesic strategies do not completely solve this issue and have their own drawbacks. Cryoablation of intercostal nerves has been proposed as an appealing alternative to address the postoperative pain. METHODS: Between 2020 and 2021, data of all consecutive patients undergoing TAA or TAAA aortic aneurysms open repair with electroneurography-guided cryoablation of intercostal nerves were collected. Postoperative pain was recorded using patient-reported 0-10 numeric rating scale (NRS). Need for adjunctive opioid drugs and postoperative complications were also recorded. Narcotic usage was calculated as morphine milligram equivalents (MMEs) per day. RESULTS: A total of 15 patients (8 males, mean age 61.1-year-old) underwent open surgical repair for TAAA (13 cases) or TAA (2 cases) and received intercostal nerve cryoablation. There were no intraoperative deaths and cases of spinal cord ischemia. Overall, 70 intercostal nerves underwent electroneurography-guided cryoablation, with a mean of 4.6 nerves per patient. On the first day after extubating, mean NRS was 4.6 and the MMEs calculated was 6.7, decreasing over the days. There was one case of pneumonia and atelectasis requiring bronchoscopy. There were no reported bowel complications. The mean postoperative length of stay was 16 days and in the intensive care unit stay was 6.5 days. CONCLUSIONS: Electroneurography-guided cryoablation of intercostal nerves is a safe and reproducible technique which can be used in addition to systemic pain management for TAA and TAAA open repair.


Subject(s)
Aortic Aneurysm, Thoracic , Cryosurgery , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/surgery , Cryosurgery/adverse effects , Cryosurgery/methods , Humans , Intercostal Nerves/surgery , Male , Middle Aged , Pain Management/adverse effects , Pain Management/methods , Pain, Postoperative/diagnosis , Pain, Postoperative/etiology , Pain, Postoperative/prevention & control , Retrospective Studies , Treatment Outcome
20.
Neurophysiol Clin ; 52(3): 232-241, 2022 Jun.
Article in English | MEDLINE | ID: mdl-34998631

ABSTRACT

OBJECTIVES: Despite the introduction of several adjuncts to improve spinal perfusion, spinal cord ischemia (SCI) remains a devastating complication of thoracoabdominal aortic aneurysm (TAAA) repair. Our aim was to assess the effects on clinical outcome of interventions triggered by motor evoked potentials (MEP) alerts. Furthermore, we want to assess whether a multimodal intraoperative neurophysiologic monitoring (IONM) protocol is helpful for stratifying patients according to the risk of SCI at the end of the vascular phase of surgery. METHODS: We prospectively studied one-hundred consecutive patients who underwent TAAA repair. We applied a multimodal IONM including MEP, somatosensory evoked potentials (SEP) and peripheral nerve monitoring techniques. Signal deteriorations were classified as reversible/irreversible according to whether they recovered or not at the end of monitoring (EOM), set at the end of the vascular phase of surgery. Significant MEP changes drove a series of corrective measures aimed to improve spinal perfusion. RESULTS: The rate of immediate postoperative motor deficits consistent with SCI was significantly higher with irreversible MEP deteriorations compared to reversible ones. The interpretation of MEP findings at the EOM led to the development of risk categories for SCI, based on the association between MEP results and motor outcome. CONCLUSIONS: Our data seem to justify interventions made to reverse MEP deterioration in order to improve the clinical outcome. A multimodal IONM protocol could improve MEP interpretation at the end of the vascular phase of surgery, supporting the surgeon in their decision-making, before concluding vascular maneuvers.


Subject(s)
Aortic Aneurysm, Thoracic , Intraoperative Neurophysiological Monitoring , Spinal Cord Ischemia , Aortic Aneurysm, Thoracic/complications , Aortic Aneurysm, Thoracic/surgery , Decision Making , Evoked Potentials, Motor/physiology , Feedback , Humans , Intraoperative Neurophysiological Monitoring/adverse effects , Retrospective Studies , Spinal Cord Ischemia/etiology , Spinal Cord Ischemia/prevention & control
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