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1.
N Engl J Med ; 390(1): 9-19, 2024 Jan 04.
Artigo em Inglês | MEDLINE | ID: mdl-37888915

RESUMO

BACKGROUND: Among patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease, angioplasty has been associated with frequent reintervention and adverse limb outcomes from restenosis. The effect of the use of drug-eluting resorbable scaffolds on these outcomes remains unknown. METHODS: In this multicenter, randomized, controlled trial, 261 patients with CLTI and infrapopliteal artery disease were randomly assigned in a 2:1 ratio to receive treatment with an everolimus-eluting resorbable scaffold or angioplasty. The primary efficacy end point was freedom from the following events at 1 year: amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion. The primary safety end point was freedom from major adverse limb events at 6 months and from perioperative death. RESULTS: The primary efficacy end point was observed (i.e., no events occurred) in 135 of 173 patients in the scaffold group and 48 of 88 patients in the angioplasty group (Kaplan-Meier estimate, 74% vs. 44%; absolute difference, 30 percentage points; 95% confidence interval [CI], 15 to 46; one-sided P<0.001 for superiority). The primary safety end point was observed in 165 of 170 patients in the scaffold group and 90 of 90 patients in the angioplasty group (absolute difference, -3 percentage points; 95% CI, -6 to 0; one-sided P<0.001 for noninferiority). Serious adverse events related to the index procedure occurred in 2% of the patients in the scaffold group and 3% of those in the angioplasty group. CONCLUSIONS: Among patients with CLTI due to infrapopliteal artery disease, the use of an everolimus-eluting resorbable scaffold was superior to angioplasty with respect to the primary efficacy end point. (Funded by Abbott; LIFE-BTK ClinicalTrials.gov number, NCT04227899.).


Assuntos
Angioplastia , Implante de Prótese Vascular , Isquemia Crônica Crítica de Membro , Stents Farmacológicos , Doença Arterial Periférica , Artéria Poplítea , Humanos , Implantes Absorvíveis , Angioplastia/efeitos adversos , Angioplastia/métodos , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/métodos , Implante de Prótese Vascular/métodos , Doença Crônica , Isquemia Crônica Crítica de Membro/etiologia , Isquemia Crônica Crítica de Membro/cirurgia , Everolimo/administração & dosagem , Everolimo/efeitos adversos , Everolimo/uso terapêutico , Imunossupressores/administração & dosagem , Imunossupressores/efeitos adversos , Imunossupressores/uso terapêutico , Isquemia/tratamento farmacológico , Isquemia/etiologia , Isquemia/cirurgia , Doença Arterial Periférica/complicações , Doença Arterial Periférica/tratamento farmacológico , Doença Arterial Periférica/cirurgia , Artéria Poplítea/cirurgia , Alicerces Teciduais , Resultado do Tratamento
2.
J Endovasc Ther ; : 15266028231158946, 2023 Mar 10.
Artigo em Inglês | MEDLINE | ID: mdl-36896877

RESUMO

CLINICAL IMPACT: After percutaneous deep venous arterialization (pDVA), the created arteriovenous circuit needs time to develop. Postprocedural care in patients after pDVA is essential in order to create optimal conditions for maturation of the circuit, and thus save the limb. However, current literature mainly focusses on the procedure itself, making postprocedural care an underexposed topic. Therefore, this study presents an overview of the available literature of postprocedural care of pDVA patients and provides recommendations based on expert opinion when current knowledge is limited.

3.
J Endovasc Ther ; : 15266028231210220, 2023 Nov 27.
Artigo em Inglês | MEDLINE | ID: mdl-38009322

RESUMO

BACKGROUND: Chronic limb-threatening ischemia (CLTI) is known for its high rates of major amputation and mortality. Conventional revascularization techniques often fail in CLTI patients due to the heavily diseased arteries. Foot vein arterialization (FVA) has been proposed as an alternative technique to provide arterial blood to the foot by using the disease-free venous bed. OBJECTIVES: This systematic review and meta-analysis aimed to determine outcomes of surgical FVA (sFVA) and percutaneous FVA (pFVA) at 6 and 12 months post-procedure. DATA SOURCES: PubMed, Scopus, Web of Science, and the Cochrane Library databases were searched to identify papers reporting clinical outcomes of sFVA and pFVA published between January 1966 and March 2023. METHODS: Databases were searched for eligible studies. A meta-analysis was performed to evaluate the limb salvage rate, overall survival rate, and wound healing rate at 6 and 12 months. RESULTS: A total of 27 studies were included, with 753 patients and 793 limbs. Of the included studies, 16 analyzed the sFVA technique and 11 the pFVA technique. Of the included patients, 86.3% were Rutherford 5/6 in the sFVA group versus 98.4% in the pFVA group. The pooled limb salvage rate at 6 and 12 months was 78.1% and 74.1% in the sFVA group and 81.7% and 78.6% in the pFVA group, respectively. Wound healing rates were not reported in the sFVA group. In the pFVA group, the pooled wound healing rates were 48.1% and 64.5% at 6 and 12 months, respectively. CONCLUSION: This study showed promising results after FVA among a large population of CLTI patients. In high-risk patients, pFVA is a feasible option with favorable limb salvage and wound healing rates.

4.
Ann Vasc Surg ; 90: 27-32, 2023 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-36509370

RESUMO

BACKGROUND: To offer an alternative to conventional techniques of lateral prosthetic anastomosis on arteries which require a long training, and impose an extensive open surgery, we are proposing the clampless 2 device (C2D) implanted by a simple arterial puncture and allows a lateral implantation of a polytetrafluoroethylene (PTFE) vascular graft in an artery, without arterial clamping or suture. METHODS: C2D is a "T" shaped 25-mm long and 8-mm diameter Nitinol stent with a 6-mm PTFE graft prosthesis mounted laterally on the stent, and implanted in an artery, via a 21-French sheath, and a compliant balloon inflation. In vitro testing of the C2D was first performed on a bench including a segment of a 7-mm internal diameter pig abdominal aorta. A series of 5 consecutive C2D implantation was analyzed with evaluation of the implantation time and the fluid losses at a fluid pressure of 80 and 150 mm Hg. The C2D implantation was finally controlled by angioscopy. An aorto-iliac bypass was then secondly performed on 8 living sows, with a side-to-end C2D implantation in the infrarenal abdominal aorta, followed by a conventional end-to-end prosthetic left iliac trunk anastomosis. The C2D and distal conventional anastomotic times were evaluated, as well as the total operative time and blood loss. A postoperative angiogram was systematically performed. RESULTS: The C2D was successfully implanted in all 5 in vitro tests, with an average implantation time of 2'58 (range: 2'25-3'22). The mean value of fluid losses was 84 ml (range: 67-94 ml), with no fluid leakage occurring at 80- and 150-mm Hg pressure. All anastomoses were patent after macroscopic study by angioscopy with a perfect application of the stent in the aortic wall. In 8 living sows (mean weight: 42 kg, 37-50 kg), an aorto-left iliac bypass was successfully implanted in all cases, with a total mean procedure time of 101 min (range: 90-130 min), and an average fluid loss of 77 ml (range:20-120 ml). The mean implantation time was 4'39 (range 3'29-5'52) for C2D and 16 min (range 12-17 min) to perform the conventional distal prosthetic-iliac anastomosis. Systematic arteriographic and angioscopy control showed perfect patency of the C2D implantations. CONCLUSIONS: Preliminary in vitro and acute in vivo testing of C2D implantation show good early results, allowing further long-lasting pig experiments on the way to human homologation.


Assuntos
Implante de Prótese Vascular , Humanos , Suínos , Animais , Feminino , Constrição , Resultado do Tratamento , Aorta Abdominal/cirurgia , Stents , Anastomose Cirúrgica , Suturas , Politetrafluoretileno , Artéria Ilíaca/cirurgia , Prótese Vascular
5.
Catheter Cardiovasc Interv ; 100(7): 1273-1283, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36385562

RESUMO

OBJECTIVES: The long-term data on the use of drug-coated balloons (DCBs) for femoropopliteal atherosclerotic lesions in the real-world setting are limited, even more so for racially and geographically distinct populations. The present analysis reports the 5-year safety and effectiveness outcomes of a DCB in the Asian subset of the prospective, real-world IN.PACT Global Study. METHODS: The IN.PACT Global Study was a prospective, multicenter, international, single-arm study designed to assess the long-term safety and effectiveness of the IN.PACT Admiral DCB in real-world participants with femoropopliteal artery disease. The present analysis included 114 Asian participants (138 lesions) treated in South Korea and Singapore. Assessments through 5 years included freedom from clinically driven target lesion revascularization, the safety endpoint (a composite of freedom from device- and procedure-related mortality through 30 days; and freedom from major target limb amputation and clinically driven target vessel revascularization within 60 months after the index procedure) and major adverse events. RESULTS: In this prespecified Asian subset, there was a high incidence of diabetes mellitus (54.4%), hypertension (78.1%), coronary artery disease (43.9%), and concomitant below-the-knee vascular disease of target leg (39.5%). Mean lesion length was 17.4 ± 12.4 cm; 26.8% were in-stent restenosis, and more than half of the lesions were totally occluded (51.4%) and calcified (54.3%). The 5-year Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization was 77.1% (95% confidence interval: 67.0%-84.5%). The safety composite endpoint was 76.0%; the cumulative incidence of all-cause mortality was 19.9%, and no major target limb amputations were reported through 5 years. CONCLUSIONS: This subset analysis of Asian participants from the IN.PACT Global Study demonstrated consistent results with the previously reported data of the IN.PACT Admiral DCB. The data confirm the durable clinical effectiveness and safety profile of the DCB through 5 years for femoropopliteal atherosclerotic disease in this real-world population.


Assuntos
Angioplastia com Balão , Fármacos Cardiovasculares , Doença Arterial Periférica , Dispositivos de Acesso Vascular , Humanos , Paclitaxel/efeitos adversos , Artéria Poplítea/diagnóstico por imagem , Estudos Prospectivos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Fármacos Cardiovasculares/efeitos adversos , Materiais Revestidos Biocompatíveis , Grau de Desobstrução Vascular , Resultado do Tratamento , Fatores de Tempo , Angioplastia com Balão/efeitos adversos , Artéria Femoral/diagnóstico por imagem
6.
J Vasc Interv Radiol ; 33(8): 913-918, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35597367

RESUMO

PURPOSE: To assess the feasibility and outcomes of an approach utilizing transbasilic access for balloon-assisted maturation (BAM) of brachiocephalic arteriovenous fistulas (BCAVFs). MATERIALS AND METHODS: This retrospective analysis comprised 28 patients (mean age, 63 years ± 10.8) who underwent endovascular treatment of their immature BCAVFs via a basilic approach from December 2016 to December 2018. The mean age of the BCAVFs was 3.3 months ± 1.4 at the time of BAM. Other demographic data, vascular access characteristics, procedural data, technical and clinical success rates, and adverse events were also evaluated. RESULTS: All patients had inflow juxta-anastomotic stenoses, with 4 patients (14%) having concomitant outflow tract stenoses and 1 patient (4%) having a short-segment occlusion at the stenotic juxta-anastomotic segment. Technical success was achieved in 27 patients (96%). The mean diameter of the largest balloon used was 5.7 mm ± 0.6. Clinical success was achieved in 22 patients (79%), with 6 patients (21%) requiring a subsequent additional intervention before successful cannulation. No perioperative adverse events were observed. CONCLUSIONS: The retrograde basilic approach is feasible, safe, and effective for BAM of BCAVFs.


Assuntos
Angioplastia com Balão , Fístula Arteriovenosa , Derivação Arteriovenosa Cirúrgica , Angioplastia com Balão/efeitos adversos , Fístula Arteriovenosa/etiologia , Derivação Arteriovenosa Cirúrgica/efeitos adversos , Constrição Patológica/etiologia , Oclusão de Enxerto Vascular/terapia , Humanos , Lactente , Pessoa de Meia-Idade , Diálise Renal , Estudos Retrospectivos , Resultado do Tratamento , Grau de Desobstrução Vascular
7.
Vasc Med ; 26(2): 195-199, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33507844

RESUMO

Previous studies on everolimus-eluting bioresorbable vascular scaffolds (BVS) have shown promising 1-year primary patency rates in infrapopliteal arteries. Literature from large cohorts on long-term outcomes with the infrapopliteal Absorb BVS (Abbott Vascular) is lacking. The aim of this study is to pool published and unpublished data to provide a more precise estimate of the 24-month outcomes of Absorb BVS for the treatment of infrapopliteal disease. For the pooled analysis, updated original and newly collected data from three cohorts on treatment with the Absorb BVS for de novo infrapopliteal lesions were combined. The primary endpoint was freedom from restenosis. Secondary endpoints were freedom from clinically driven target lesion revascularization (CD-TLR), major amputation and survival. The pooled analysis included a total of 121 patients with 161 lesions, treated with 189 Absorb BVS in 126 limbs. The mean age of the patients was 73 years, 57% had diabetes mellitus, and 75% were classified as Rutherford-Becker class 5 or 6. Of the 161 lesions, 101 (63%) were calcified and 36 (22%) were occlusions. Successful deployment was achieved with all scaffolds. Freedom from restenosis was 91.7% and 86.6% at 12 and 24 months, respectively, and freedom from CD-TLR was 97.2% and 96.6%. Major amputation occurred in 1.6% of the limbs. Overall survival was 85% at 24 months. In conclusion, this pooled analysis represents the largest reported analysis of mid-term results of the Absorb BVS for the management of chronic limb-threatening ischemia. At 24 months, the Absorb BVS was safe with promising clinical outcomes for the treatment of infrapopliteal disease.


Assuntos
Doença da Artéria Coronariana , Everolimo , Doença Arterial Periférica , Implantes Absorvíveis , Idoso , Everolimo/administração & dosagem , Humanos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Artéria Poplítea/diagnóstico por imagem , Desenho de Prótese , Resultado do Tratamento , Grau de Desobstrução Vascular
8.
Vasc Med ; 26(3): 267-272, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33733963

RESUMO

The fluoropolymer-coated, paclitaxel-eluting Eluvia stent has shown promising results for the endovascular treatment of femoropopliteal artery lesions in patients with claudication. The aim of the current study was to evaluate efficacy and safety outcomes of the Eluvia stent for the treatment of long femoropopliteal lesions in Asian patients. This is a single-center, retrospective study. The primary endpoint was primary patency at 1 year. Secondary outcomes were 30-days complication rate, technical success, 1-year freedom from clinically driven target lesion revascularization (CD-TLR), limb salvage, survival, amputation-free survival (AFS), wound healing, and clinical improvement. A total of 64 patients with 67 femoropopliteal lesions were included; 78% suffered from diabetes and 84% had chronic limb-threatening ischemia (CLTI). Of those with ischemic wounds, 79% did not have run-off to the foot. Mean lesion length was 193 ± 128 mm and 52% were severely calcified. Primary patency at 1 year was 84% in the overall cohort and 91% in patients with complete lesion coverage with the Eluvia stent. Technical success was achieved in 100% of the cases and 30-day complications occurred in six patients. Twelve-month freedom from CD-TLR, limb salvage, survival, and AFS were 92%, 93%, 85%, and 80%, respectively. In 80% of patients, complete wound healing was experienced and 84% had clinical improvement after 1 year. The Eluvia stent showed promising 12-month patency and clinical results for femoropopliteal treatment in this CLTI-dominant patient population with severely calcified, long lesions. Patient numbers were, however, small; larger trials are required to validate these findings. Aneurysmal change seen in some cases also needs further investigation.


Assuntos
Stents Farmacológicos , Paclitaxel , Doença Arterial Periférica , Isquemia Crônica Crítica de Membro , Artéria Femoral/diagnóstico por imagem , Humanos , Salvamento de Membro , Paclitaxel/efeitos adversos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Artéria Poplítea , Estudos Retrospectivos , Resultado do Tratamento , Grau de Desobstrução Vascular
9.
J Endovasc Ther ; 27(4): 658-665, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32419597

RESUMO

Purpose: To evaluate the midterm results of patients suffering from no-option chronic limb-threatening ischemia (CLTI) treated with a dedicated system for percutaneous deep venous arterialization (pDVA). Materials and Methods: Thirty-two consecutive CLTI patients (mean age 67±14 years; 20 men) treated with pDVA using the Limflow device at 4 centers between 11 July 2014 and 11 June 2018 were retrospectively analyzed. Of all patients, 21 (66%) had diabetes, 8 (25%) were on immunosuppression, 4 (16%) had dialysis-dependent renal failure, 9 (28%) had Rutherford category 6 ischemia, and 25 (78%) were deemed at high risk of amputation. The primary outcome was amputation-free survival (AFS) at 6 months. Secondary outcomes were wound healing, limb salvage, and survival at 6, 12, and 24 months. Results: Technical success was achieved in 31 patients (96.9%). The median follow-up was 34 months (range 16-63). At 6, 12, and 24 months, estimates were 83.9%, 71.0%, and 67.2% for AFS, 86.8%, 79.8% and 79.8% for limb salvage, and 36.6%, 68.2%, and 72.7% for complete wound healing, respectively. Median time to complete wound healing was 4.9 months (range 0.5-15). The DVA circuit occluded during follow-up in 21 patients; the median time to occlusion was 2.6 months. Reintervention for occlusion was performed in 17 patients: 16 because of unhealed wounds and 1 for a newly developed ulcer. Conclusion: This study represents the largest population of patients with no-option CLTI treated with pDVA using the LimFlow device with midterm results. In this complex group of patients, pDVA using the LimFlow device has been shown to be feasible, with a high technical success rate and AFS at 6 up to 24 months coupled with wound healing. In selected patients with no-option CLTI, pDVA could be a recommended treatment to prevent amputation and heal wounds.


Assuntos
Procedimentos Endovasculares/instrumentação , Isquemia/cirurgia , Doenças Vasculares Periféricas/cirurgia , Idoso , Idoso de 80 Anos ou mais , Amputação Cirúrgica , Doença Crônica , Procedimentos Endovasculares/efeitos adversos , Feminino , Humanos , Isquemia/diagnóstico por imagem , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doenças Vasculares Periféricas/diagnóstico por imagem , Doenças Vasculares Periféricas/fisiopatologia , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular , Cicatrização
10.
J Endovasc Ther ; 27(4): 616-622, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32469296

RESUMO

Purpose: To report an experience with the Absorb bioresorbable vascular scaffold (BVS) in an Asian cohort with chronic limb-threatening ischemia (CLTI) from the DISAPEAR (Drug Impregnated Bioresorbable Stent in Asian Population Extremity Arterial Revascularization) registry. Materials and Methods: A retrospective analysis was conducted of 41 patients (median age 64 years; 23 men) with CLTI owing to >50% de novo infrapopliteal lesions (n=53) treated with the Absorb BVS between August 2012 and June 2017. The majority of patients (37, 90%) had diabetes, 24 (59%) had ischemic heart disease, and 39 (95%) had Rutherford category 5/6 ischemia with tissue loss. The mean lesion length was 22.7±17.2 mm; 10 (24%) lesions were severely calcified. Assessments included technical success, primary patency, freedom from clinically-driven target lesion revascularization (CD-TLR), amputation-free survival, limb salvage, complete wound healing, resolution of rest pain, and resolution of CLTI without TLR at 6 and 12 months after the index intervention. Results: Overall, 69 scaffolds were implanted in the 53 lesions, with 100% technical success. There were no deaths within 30 days of the index procedure. The primary patency rates at 6 and 12 months were 95% and 86%, respectively. The corresponding rates of freedom from CD-TLR were 98% and 93%, respectively. Freedom from major amputation was 98% at both time points, and amputation-free survival was 93% and 85% at 6 and 12 months after the index procedure. Wound healing occurred in 31 patients (79%) with Rutherford category 5/6 ischemia by the end of 12 months. Conclusion: The Absorb BVS demonstrated good 1-year patency and clinical outcomes in CLTI patients with complex infrapopliteal disease.


Assuntos
Implantes Absorvíveis , Fármacos Cardiovasculares/administração & dosagem , Procedimentos Endovasculares/instrumentação , Everolimo/administração & dosagem , Isquemia/terapia , Doença Arterial Periférica/terapia , Artéria Poplítea , Idoso , Amputação Cirúrgica , Povo Asiático , Fármacos Cardiovasculares/efeitos adversos , Doença Crônica , Procedimentos Endovasculares/efeitos adversos , Everolimo/efeitos adversos , Feminino , Humanos , Isquemia/diagnóstico por imagem , Isquemia/etnologia , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/etnologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Desenho de Prótese , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Singapura , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular , Cicatrização
12.
J Endovasc Ther ; 26(1): 7-17, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30591004

RESUMO

PURPOSE: To describe a preliminary experience in treating no-option critical limb ischemia (CLI) patients with a hybrid foot vein arterialization (HFVA) technique combining open plus endovascular approaches. MATERIALS AND METHODS: Between May 2016 and January 2018, 35 consecutive patients (mean age 68±12 years; 28 men) with 36 no-option CLI limbs underwent HFVA in our center. All limbs had grade 3 WIfI (Wound, Ischemia, and foot Infection) ischemia, and the wound classification was grade 1 in 4 (11%) limbs, grade 2 in 4 (11%), and grade 3 in 28 (78%). Surgical bypass was done on the medial marginal vein or a posterior tibial vein, followed by endovascular removal of foot vein valves and embolization of foot vein collaterals. A "tension-free" surgical approach was used to treat foot lesions. RESULTS: At a mean follow-up of 10.8±2 months, limb salvage was achieved in 25 (69%) limbs and wound healing in 16 (44%); 9 patients presented an unhealed wound. Eleven (31%) patients underwent a major amputation (2 below the knee and 9 thigh). One patient with an unhealed wound and open bypass died of myocardial infarction. CONCLUSION: HFVA is a promising technique able to achieve acceptable rates of limb salvage and wound healing in no-option patients generally considered candidates for an impending major amputation. Further studies are needed to standardize the technique and better identify patients who can benefit from this approach.


Assuntos
Embolização Terapêutica , Procedimentos Endovasculares , Pé/irrigação sanguínea , Isquemia/cirurgia , Doença Arterial Periférica/cirurgia , Veias/cirurgia , Idoso , Idoso de 80 Anos ou mais , Amputação Cirúrgica , Estado Terminal , Embolização Terapêutica/efeitos adversos , Embolização Terapêutica/mortalidade , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Humanos , Isquemia/diagnóstico por imagem , Isquemia/mortalidade , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Dados Preliminares , Fluxo Sanguíneo Regional , Reoperação , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Veias/diagnóstico por imagem , Veias/fisiopatologia , Cicatrização
13.
J Vasc Interv Radiol ; 30(9): 1361-1368.e2, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31371138

RESUMO

PURPOSE: To evaluate the safety and effectiveness of below-the-ankle (BTA) angioplasty and to assess whether additional BTA angioplasty after below-the-knee (BTK) angioplasty would improve clinical outcomes in patients with critical limb ischemia. MATERIALS AND METHODS: Two authors independently performed the search, study selection, assessment of methodological quality, and data extraction for this systematic review and meta-analysis. MEDLINE, Embase, and the Cochrane Database of Systematic Reviews were searched. Articles were eligible if it was reported that BTA angioplasty was performed and if the articles were published in English and had the full text available. Methodological quality was assessed using the Methodological Index for Non-Randomized Studies (MINORS) score. The primary outcome was 12-month limb salvage rate. Secondary outcomes were 12-month amputation-free survival, technical success, complications, survival, and freedom from reintervention. RESULTS: Ten articles met the inclusion criteria, reporting a total of 478 patients with BTA angioplasty performed in 524 legs. Three of the 10 included studies compared BTK angioplasty only to BTK angioplasty and additional BTA angioplasty. The pooled 12-month limb salvage rate was 92% (95% confidence interval [CI], 0.88-0.96). No statistically significant difference was found in limb salvage when additional BTA angioplasty was compared to BTK angioplasty only (odds ratio [OR], 1.23; 95% CI, 0.61-2.49). The pooled 12-month amputation-free survival was 78% (95% CI, 0.69-0.87). No statistically significant difference was found in amputation-free survival rate when additional BTA angioplasty was compared to BTK angioplasty only (OR, 1.58; 95% CI, 0.95-2.64). The methodological quality of the studies included was moderate, according to the MINORS score. CONCLUSIONS: This systematic review and meta-analysis showed that additional BTA angioplasty is a safe and feasible procedure, with a 92% pooled proportion of limb salvage at 12 months.


Assuntos
Angioplastia , Tornozelo/irrigação sanguínea , Isquemia/terapia , Doença Arterial Periférica/terapia , Idoso , Amputação Cirúrgica , Angioplastia/efeitos adversos , Estado Terminal , Feminino , Humanos , Isquemia/diagnóstico por imagem , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Intervalo Livre de Progressão , Fluxo Sanguíneo Regional , Retratamento , Fatores de Risco , Fatores de Tempo
14.
Vasa ; 47(1): 17-22, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29065790

RESUMO

Patients with critical limb ischaemia have a poor life expectancy. Aggressive revascularization is accepted in order to preserve their independence in the final phase of their lives. Bypass surgery and more recently endovascular interventions with angioplasty and stenting have become the treatment of choice to prevent amputation and to resolve pain. However, as many as 20 % of patients with critical limb ischaemia are unsuitable candidates for a vascular intervention because of extensive occlusions of outflow in the crural and pedal vessels. Such "no-option critical limb ischaemia" may be treated with venous arterialization. In the present review, we discuss the history of the venous arterialization procedure, the mechanisms, the different techniques, and complications of venous arterialization.


Assuntos
Isquemia/cirurgia , Salvamento de Membro , Extremidade Inferior/irrigação sanguínea , Doença Arterial Periférica/cirurgia , Humanos , Fluxo Sanguíneo Regional , Grau de Desobstrução Vascular
15.
J Endovasc Ther ; 24(3): 337-341, 2017 06.
Artigo em Inglês | MEDLINE | ID: mdl-28351311

RESUMO

PURPOSE: To describe relevant technical details with which to facilitate safe and effective use of the Absorb coronary bioresorbable vascular scaffold (BVS) in lower extremity arteries. TECHNIQUE: The Absorb BVS is a balloon-expandable, poly-l-lactide structure covered in a poly-d,l-lactide bioresorbable polymer that contains the antiproliferative drug everolimus. As a polymeric structure, it has a number of unique physical, handling, and imaging properties that may differ from metallic stents and pose a challenge to the interventionist. Attention must be paid to lesion selection, preparation, scaffold sizing, deployment, and postdilation to achieve optimal outcomes. A detailed description of these issues and deployment techniques is offered based on experience using this BVS in below-the-knee arteries. CONCLUSION: The Absorb BVS may have application in the infrapopliteal circulation; however, its unique properties warrant careful consideration before use in the lower limb.


Assuntos
Implantes Absorvíveis , Angioplastia com Balão/instrumentação , Materiais Revestidos Biocompatíveis , Doença Arterial Periférica/terapia , Artéria Poplítea , Angiografia , Angioplastia com Balão/efeitos adversos , Fármacos Cardiovasculares/administração & dosagem , Everolimo/administração & dosagem , Humanos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Poliésteres/química , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Desenho de Prótese , Fatores de Tempo , Resultado do Tratamento
16.
J Endovasc Ther ; 24(5): 619-626, 2017 10.
Artigo em Inglês | MEDLINE | ID: mdl-28697694

RESUMO

PURPOSE: To report the initial clinical experience with percutaneous deep vein arterialization (PDVA) to treat critical limb ischemia (CLI) via the creation of an arteriovenous fistula. METHODS: Seven patients (median age 85 years; 5 women) with CLI and no traditional endovascular or surgical revascularization options (no-option CLI) were recruited in a pilot study to determine the safety of PDVA. All patients were diabetic; 4 had Rutherford category 6 ischemia. Six were classified at high risk of amputation based on the Society for Vascular Surgery WIfI (wound, ischemia, and foot infection) classification. The primary safety endpoints were major adverse limb events and major adverse coronary events through 30 days and serious adverse events through 6 months. Secondary objectives included clinical efficacy based on outcome measures including thermal measurement, transcutaneous partial pressure of oxygen (TcPO2), clinical improvement at 6 months, and wound healing. RESULTS: The primary safety endpoints were achieved in 100% of patients, with no deaths, above-the-ankle amputations, or major reinterventions at 30 days. The technical success rate was 100%. Two myocardial infarctions occurred within 30 days, each with minor clinical consequences. All patients demonstrated symptomatic improvement with formation of granulation tissue, resolution of rest pain, or both. Complete wound healing was achieved in 4 of 7 patients and 5 of 7 patients at 6 and 12 months, respectively, with a median healing time of 4.6 months (95% confidence interval 84-192). Median postprocedure peak TcPO2 was 61 mm Hg compared to a preprocedure level of 8 mm Hg (p=0.046). At the time of wound healing, 4 of 5 of patients achieved TcPO2 levels of >40 mm Hg. There were 2 major amputations, 1 above the knee after PDVA thrombosis and 1 below the knee for infection. Three patients died of causes unrelated to the procedure or study device at 6, 7, and 8 months, respectively. Limb salvage was 71% at 12 months. CONCLUSION: PDVA is an innovative approach for treating no-option CLI and represents an alternative option for the "desert foot," potentially avoiding major amputation. Our results demonstrate its safety and feasibility, with promising early clinical results in this small cohort.


Assuntos
Derivação Arteriovenosa Cirúrgica/métodos , Cateterismo Periférico/métodos , Isquemia/cirurgia , Extremidade Inferior/irrigação sanguínea , Doença Arterial Periférica/terapia , Idoso , Idoso de 80 Anos ou mais , Amputação Cirúrgica , Derivação Arteriovenosa Cirúrgica/efeitos adversos , Derivação Arteriovenosa Cirúrgica/instrumentação , Cateterismo Periférico/efeitos adversos , Cateterismo Periférico/instrumentação , Estado Terminal , Estudos de Viabilidade , Feminino , Humanos , Isquemia/diagnóstico por imagem , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Projetos Piloto , Complicações Pós-Operatórias/cirurgia , Estudos Prospectivos , Recuperação de Função Fisiológica , Fluxo Sanguíneo Regional , Reoperação , Fatores de Risco , Stents , Fatores de Tempo , Resultado do Tratamento , Dispositivos de Acesso Vascular , Cicatrização
19.
Ann Vasc Surg ; 29(7): 1454.e21-5, 2015 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-26133995

RESUMO

Mesentericoportal venous thrombosis (MVT) is a rare condition, accounting for 5-15% of acute mesenteric ischemia. Primary MVT is even rarer, with some reports quoting an incidence rate of 10-30% of reported cases. It presents a diagnostic challenge and is associated with a significant mortality rate, ranging from 13% to 50%. As it is an uncommon condition, the evidence in current literature regarding the treatment of MVT is limited. We discuss our surgical experience with a case of acute primary MVT that was managed with good clinical outcome and discuss the current evidence for the treatment of acute MVT. A 50-year-old Chinese lady with no significant past medical history presented with a 2-day history of abdominal pain and epigastric tenderness on examination. Computed tomography of her abdomen and pelvis showed evidence of extensive acute thrombi present in portal confluence extending into the superior mesenteric vein, associated with submucosal edema in some central jejunal loops. Despite systemic anticoagulation therapy with intravenous heparin, the patient deteriorated clinically, and decision was made for an exploratory laparotomy, small bowel resection, and open thrombectomy. Postoperative recovery was uneventful. She was discharged on postoperative day 13 with lifelong oral anticoagulation. In conclusion, we describe the successful management of a patient with extensive acute primary MVT where open thrombectomy was performed together with small bowel resection.


Assuntos
Isquemia Mesentérica/cirurgia , Oclusão Vascular Mesentérica/cirurgia , Veias Mesentéricas/cirurgia , Veia Porta/cirurgia , Trombectomia , Doença Aguda , Administração Oral , Anticoagulantes/administração & dosagem , Procedimentos Cirúrgicos do Sistema Digestório , Feminino , Humanos , Isquemia Mesentérica/diagnóstico , Isquemia Mesentérica/fisiopatologia , Oclusão Vascular Mesentérica/diagnóstico , Oclusão Vascular Mesentérica/fisiopatologia , Veias Mesentéricas/diagnóstico por imagem , Veias Mesentéricas/fisiopatologia , Pessoa de Meia-Idade , Flebografia/métodos , Veia Porta/diagnóstico por imagem , Veia Porta/fisiopatologia , Circulação Esplâncnica , Tomografia Computadorizada por Raios X , Resultado do Tratamento , Ultrassonografia
20.
JACC Cardiovasc Interv ; 17(5): 589-607, 2024 Mar 11.
Artigo em Inglês | MEDLINE | ID: mdl-38244007

RESUMO

Patients with chronic limb-threatening ischemia, the terminal stage of peripheral artery disease, are frequently afflicted by below-the-knee disease. Although all patients should receive guideline-directed medical therapy, restoration of inline flow is oftentimes necessary to avoid limb loss. Proper patient selection and proficiency in endovascular techniques for below-the-knee revascularization are intended to prevent major amputation and promote wound healing. This review, a consensus among an international panel of experienced operators, provides guidance on these challenges from an endovascular perspective and offers techniques to navigate this complex disease process.


Assuntos
Procedimentos Endovasculares , Doença Arterial Periférica , Humanos , Resultado do Tratamento , Fatores de Risco , Salvamento de Membro , Extremidade Inferior/irrigação sanguínea , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/métodos , Isquemia/diagnóstico por imagem , Isquemia/terapia , Estudos Retrospectivos , Doença Crônica
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