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2.
Port J Card Thorac Vasc Surg ; 31(1): 47-51, 2024 May 13.
Artigo em Inglês | MEDLINE | ID: mdl-38743524

RESUMO

Epithelioid angiosarcoma is a rare high-grade vascular neoplasm with a poor prognosis. We present an anticoagulated 77-year-old man, with a history of popliteal/soleal vein thrombosis in the previous month, complaining of ipsilateral persistent lower limb pain and claudication. Absent popliteal/distal pulses prompted an arterial doppler ultrasound (DUS), revealing thrombosis of the distal superficial femoral artery and a popliteal mass. As the arterial wall's integrity could not be appropriately evaluated by DUS, adventitial cystic disease of the popliteal artery was suspected. Computed tomography angiography and magnetic resonance imaging findings were also suggestive. Due to refractory pain, he was submitted to a popliteal mass excision along with a femoral-posterior tibial bypass. Pathology revealed an epithelioid angiosarcoma. He was referred to a Sarcoma Center, requiring hospitalization for agitation and fever. A positron emission tomography (PET) scan revealed extensive lower limb disease persistence and distant metastases. He died on the 56th day after surgery. To our knowledge, there are only 15 cases of angiosarcoma of the popliteal artery described in the literature. Ours stands out as the first one unrelated to a popliteal aneurysm. Being a highly-aggressive tumor, an early diagnosis is challenging but essential to a successful treatment, warranting the need for suspicion of this neoplasm. An early core biopsy or surgical sample may expedite the diagnosis.


Assuntos
Hemangiossarcoma , Artéria Poplítea , Neoplasias Vasculares , Humanos , Masculino , Idoso , Hemangiossarcoma/patologia , Hemangiossarcoma/cirurgia , Hemangiossarcoma/diagnóstico , Hemangiossarcoma/diagnóstico por imagem , Neoplasias Vasculares/cirurgia , Neoplasias Vasculares/patologia , Neoplasias Vasculares/diagnóstico , Neoplasias Vasculares/diagnóstico por imagem , Artéria Poplítea/patologia , Artéria Poplítea/cirurgia , Artéria Poplítea/diagnóstico por imagem , Evolução Fatal , Angiografia por Tomografia Computadorizada
5.
Catheter Cardiovasc Interv ; 103(6): 963-971, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38566517

RESUMO

BACKGROUND: Complex femoropopliteal artery disease represents a challenge. The Supera stent holds the promise of improving the results of endovascular therapy for complex femoropopliteal disease. AIMS: We aimed at appraising the early and long-term effectiveness of the Supera stent after successful subintimal angioplasty (SuperSUB strategy) for complex femoropopliteal lesions. METHODS: We conducted a multicenter, prospective, single-arm observational study including consecutive patients at participating centers in whom Supera was implanted after successful subintimal angioplasty for complex femoropopliteal lesions. RESULTS: A total of 92 patients were included Femoropopliteal arteries were the most common target, and lesion length was 261 ± 102 mm. Most procedures were technically demanding, with antegrade femoral access in 35 (38%) and retrograde distal access in 55 (60%). Supera stent length was 281 ± 111 mm, with 4, 5, and 6 mm devices being most commonly used: 32 (35%), 35 (38%), and 23 (25%), respectively. Technical success was achieved in 100% of subjects, as was clinical success (per subject), whereas procedural success (per subject) was obtained in 98%. At 24 months, freedom from clinically driven target lesion revascularization was 93%, whereas primary patency was 87%. When compared with a similar historical cohort, Supera stent use appeared to be associated with a reduction in resources. CONCLUSION: Use of Supera stent after successful subintimal recanalization of complex lower limb arterial lesions yields favorable procedural results, which are maintained over follow-up, and are associated also with a favorable resource use profile.


Assuntos
Artéria Femoral , Doença Arterial Periférica , Artéria Poplítea , Desenho de Prótese , Stents , Grau de Desobstrução Vascular , Humanos , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Estudos Prospectivos , Masculino , Feminino , Idoso , Doença Arterial Periférica/terapia , Doença Arterial Periférica/fisiopatologia , Doença Arterial Periférica/diagnóstico por imagem , Fatores de Tempo , Pessoa de Meia-Idade , Resultado do Tratamento , Idoso de 80 Anos ou mais , Fatores de Risco , Constrição Patológica
6.
Int J Cardiol ; 404: 131977, 2024 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-38508322

RESUMO

PURPOSE: To evaluate the best endovascular treatment for de novo femoropopliteal lesions at long-term follow-up through network meta-analysis of randomized controlled trials. METHODS: Medical databases were searched on September 17, 2023. 17 trials and 7 treatments were selected. Outcomes were primary patency, target lesion revascularization (TLR), major amputation and all-cause mortality at 3 and/or 5 years. RESULTS: Regarding 3-year primary patency, drug-eluting stents (DES) was the best and better than balloon angioplasty (BA; odds ratio [OR], 4.96; 95% confidence interval [CI], 2.68-9.18), bare metal stents (BMS; OR, 2.81; 95% CI, 1.45-5.46), cryoplasty (OR, 6.75; 95% CI, 2.76-16.50), covered stents (CS; OR, 3.25; 95% CI, 1.19-8.87) and drug-coated balloons (DCB; OR, 2.04; 95% CI, 1.14-3.63). Regarding 5-year primary patency, DES was the best and better than BMS (OR, 2.34; 95% CI, 1.10-4.99). Regarding 3-year TLR, DES was the best and better than BA (OR, 0.24; 95% CI, 0.13-0.44). Regarding 5-year TLR, DES was the best and better than BA (OR, 0.20; 95% CI, 0.09-0.42) and balloon angioplasty with brachytherapy (OR, 0.21; 95% CI, 0.06-0.74). Regarding 3- and 5-year major amputation, DCB was the best. Regarding 3-year mortality, DES was the best and better than CS (OR, 0.09; 95% CI, 0.01-0.67). CONCLUSIONS: DES was the best treatment regarding 3-year primary patency, TLR and mortality, and DCB was the best regarding major amputation. DES was the best treatment regarding 5-year TLR, and DCB was the best regarding primary patency and major amputation. DES and DCB should be given priority in treating femoropopliteal lesions.


Assuntos
Angioplastia com Balão , Stents Farmacológicos , Doença Arterial Periférica , Humanos , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/cirurgia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/cirurgia , Metanálise em Rede , Resultado do Tratamento , Grau de Desobstrução Vascular , Ensaios Clínicos Controlados Aleatórios como Assunto , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/cirurgia , Materiais Revestidos Biocompatíveis
7.
Vasc Med ; 29(2): 182-188, 2024 04.
Artigo em Inglês | MEDLINE | ID: mdl-38457137

RESUMO

BACKGROUND: Although the 1-year clinical outcomes of fluoropolymer-based drug-eluting stents (FP-DES) were favorable for the treatment of real-world femoropopliteal lesions in symptomatic peripheral artery disease (PAD), their performance beyond 1 year remained unknown. The current study determined the 3-year clinical course of FP-DES implantation for real-world femoropopliteal lesions. METHODS: This multicenter, prospective, observational study evaluated 1204 limbs (chronic limb-threatening ischemia, 34.8%; mean lesion length, 18.6 ± 9.9 cm, chronic total occlusion: 53.2%) of 1097 patients with PAD (age, 75 ± 9 years; diabetes mellitus, 60.8%) undergoing FP-DES implantation for femoropopliteal lesions. The primary outcome measure was 3-year restenosis. The secondary outcome measures included 3-year occlusive restenosis, stent thrombosis, target lesion revascularization (TLR), and aneurysmal degeneration. RESULTS: The 3-year cumulative occurrence of restenosis was 27.3%, whereas that of occlusive restenosis, stent thrombosis, and TLR was 16.1%, 7.3%, and 19.6%, respectively. The annual occurrence of restenosis decreased by 12.0%, 9.5%, and 5.8% in the first, second, and third year, respectively (p < 0.001). Similarly, the rates of occlusive restenosis and stent thrombosis decreased (p < 0.001 and p = 0.007, respectively), whereas the rate of TLR remained unchanged for 3 years (p = 0.15). The incidence of aneurysmal degeneration at 3 years (15.7%) did not significantly differ from that at 1 and 2 years (p = 0.69 and 0.20, respectively). CONCLUSIONS: This study highlights the favorable long-term clinical course of FP-DES in real-world practice, emphasizing the importance of monitoring for occlusive restenosis and stent thrombosis while considering the potential onset of aneurysmal degeneration.


Assuntos
Stents Farmacológicos , Doença Arterial Periférica , Trombose , Humanos , Idoso , Idoso de 80 Anos ou mais , Artéria Femoral/diagnóstico por imagem , Artéria Poplítea/diagnóstico por imagem , Polímeros de Fluorcarboneto , Resultado do Tratamento , Estudos Prospectivos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Progressão da Doença , Grau de Desobstrução Vascular , Desenho de Prótese
8.
JACC Cardiovasc Interv ; 17(5): 608-618, 2024 Mar 11.
Artigo em Inglês | MEDLINE | ID: mdl-38479962

RESUMO

BACKGROUND: Whether intraluminal drug-coated balloon (DCB) angioplasty is superior to subintimal DCB angioplasty regarding femoropopliteal (FP) chronic total occlusion (CTO) outcomes has not been systematically determined. OBJECTIVES: The aim of this study was to compare the 1-year clinical outcomes of intraluminal and subintimal DCB angioplasty for the treatment of patients with symptomatic FP CTO. METHODS: This subanalysis of POPCORN (Prospective Multi-Center Registry of Drug-Coated Balloon for Femoropopliteal Disease) evaluated 469 lesions in 469 symptomatic patients with lower extremity artery disease who presented with FP CTO and underwent DCB treatment. Wire passage (intraluminal vs subintimal) was evaluated using intravascular ultrasound. The outcome measure, 1-year freedom from restenosis, was compared between subintimal and intraluminal DCB angioplasty groups after propensity score matching analysis. The Institutional Review Boards of participating centers approved this study. Informed consent was obtained from the participants or their families. RESULTS: During the median follow-up period of 14.2 months, restenosis occurred in 140 patients. After propensity score matching, the subintimal group had a significantly lower 1-year rate of freedom from restenosis than the intraluminal group (77.0% vs 84.2%, respectively; P = 0.024). Interaction analysis revealed a more marked increased risk for restenosis in the subintimal DCB angioplasty group in patients with severe calcification, low-dose DCB use, or smoking. CONCLUSIONS: The present study revealed that intraluminal DCB angioplasty was superior to subintimal DCB angioplasty for FP CTO treatment, with a significantly better 1-year rate of freedom from restenosis.


Assuntos
Angioplastia com Balão , Doença Arterial Periférica , Humanos , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/cirurgia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/cirurgia , Estudos Prospectivos , Resultado do Tratamento , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Doença Arterial Periférica/etiologia , Angioplastia com Balão/efeitos adversos , Materiais Revestidos Biocompatíveis , Grau de Desobstrução Vascular
10.
Ann Vasc Surg ; 103: 81-88, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38395346

RESUMO

BACKGROUND: Endovascular therapy is nowadays the first choice for most patients with peripheral artery disease. The most important cause of technical failure is failure to cross the lesion with a wire. In this retrospective study, we explore possible risk factors of crossing failure. METHODS: We included all consecutive patients in whom the lesion could not be crossed in the period of the January 1, 2017-January 1, 2022. The lesions of these patients were compared with patients in whom the lesion could be crossed (2:1). The following potential anatomical risk factors were compared: location of the lesion, occlusion length, lesion length, Peripheral Arterial Calcium Scoring Scale, Peripheral Academic Research Consortium, circumferential characterization classification, and the Trans-Atlantic Inter-Society Consensus II classification. RESULTS: In 71 patients, the lesion could not be crossed; these patients were compared with 142 patients. There were significantly more patients with hypertension and hyperlipidemia in the group with crossing failure. The following factors were risk factors for crossing failure: occlusion length, lesion length, Peripheral Arterial Calcium Scoring Scale, Peripheral Academic Research Consortium, and circumferential characterization classification. CONCLUSIONS: Although conclusions should be carefully drawn from this retrospective study, calcification and length of the lesion are associated with crossing failure in the femoropopliteal segment. The Trans-Atlantic Inter-Society Consensus II classification was the best predictor of crossing failure.


Assuntos
Artéria Femoral , Doença Arterial Periférica , Artéria Poplítea , Falha de Tratamento , Calcificação Vascular , Humanos , Estudos Retrospectivos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Doença Arterial Periférica/fisiopatologia , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Masculino , Feminino , Idoso , Fatores de Risco , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/terapia , Pessoa de Meia-Idade , Medição de Risco , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Idoso de 80 Anos ou mais
11.
Circ Cardiovasc Interv ; 17(2): e013084, 2024 02.
Artigo em Inglês | MEDLINE | ID: mdl-38348677

RESUMO

BACKGROUND: The treatment of complex infra-inguinal disease with drug-coated balloons (DCBs) is associated with a significant number of patients undergoing provisional stenting to treat a suboptimal result. To determine the potential long-term impact of DCB treatment with provisional bare metal stenting in complex lesions in real-world patients, a post hoc analysis was performed on data from the IN.PACT Global Study (The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral Drug-Eluting Balloon). Five-year outcomes were compared between participants who were stented after DCB treatment versus those treated with DCB alone. METHODS: The IN.PACT Global Study enrolled 1535 participants with intermittent claudication and/or ischemic rest pain caused by femoropopliteal lesions; 1397 patients were included in this subgroup analysis (353 stented and 1044 nonstented). Effectiveness was assessed as freedom from clinically driven target lesion revascularization through 60 months. The primary safety composite end point was defined as freedom from device- and procedure-related death through 30 days, and freedom from major target limb amputation and clinically driven target vessel revascularization through 60 months. RESULTS: Lesions in the stented group were longer (15.37 versus 10.98 cm; P<0.001) and had more total occlusions (54.7% versus 28.6%; P<0.001) compared with the nonstented group. The 5-year Kaplan-Meier estimated freedom from clinically driven target lesion revascularization was similar between groups (66.8% stented versus 70.0% nonstented group, log-rank P=0.22). The safety composite end point was achieved in 64.5% stented versus 68.2% nonstented participants (log-rank P=0.19) as estimated by the Kaplan-Meier method. No significant difference was observed in the cumulative incidence of major adverse events (49.1% stented versus 45.0% nonstented; log-rank P=0.17), including all-cause death (19.6% stented versus 19.3% nonstented, log-rank P=0.99). CONCLUSIONS: In this real-world study, revascularization of complex femoropopliteal artery lesions with DCB angioplasty alone or DCB followed by provisional bare metal stenting in certain lesions achieved comparable long-term safety and clinical effectiveness. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01609296.


Assuntos
Angioplastia com Balão , Doença Arterial Periférica , Dispositivos de Acesso Vascular , Humanos , Angioplastia com Balão/efeitos adversos , Materiais Revestidos Biocompatíveis , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/patologia , Paclitaxel/efeitos adversos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Doença Arterial Periférica/etiologia , Artéria Poplítea/diagnóstico por imagem , Estudos Prospectivos , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular , Estudos Clínicos como Assunto
12.
JBJS Case Connect ; 14(1)2024 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-38422191

RESUMO

CASE: The patient, a 21-year-old female Division I track and field athlete, presents with bilateral calf pain, tightness, numbness, and swelling during activity. Initially diagnosed with chronic exertional compartment syndrome (CECS), she underwent bilateral four-compartment fasciotomies. After 4 months, she experienced persistence of some of her prefasciotomy symptoms and was referred to vascular surgery. A fibrous band was compressing the popliteal artery, making the diagnosis of popliteal artery entrapment syndrome (PAES). She underwent bilateral popliteal artery decompressions. She had a successful recovery with no recurrence of numbness, weakness, or pain. CONCLUSION: Recognize that structural PAES may coexist with CECS.


Assuntos
Síndrome Compartimental Crônica do Esforço , Síndrome do Aprisionamento da Artéria Poplítea , Feminino , Humanos , Adulto Jovem , Hipestesia , Dor , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/cirurgia
13.
Cardiovasc Intervent Radiol ; 47(5): 543-553, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38332120

RESUMO

PURPOSE: The aim of this study was to analyze the impact of calcification on the 12 and 24 months outcomes of the Eluvia™ (Boston Scientific®) drug-eluting stent (DES) for femoropopliteal occlusive disease using three different calcium scoring systems. MATERIAL AND METHODS: A single-center, retrospective cohort-study (March-2016 to December-2018) of patients treated with the Eluvia™ DES for femoropopliteal atherosclerosis was performed. Outcomes included primary and secondary patency rates and freedom from target lesion revascularization (FTLR) and were analyzed by comparing the impact of calcium burden according to the following calcium scores: Peripheral Arterial Calcium Scoring System (PACSS) score, number of vessel quadrants affected (0-4) and calcification score per Peripheral Academic Research Consortium (PARC) definitions. RESULTS: In total, 111 Patients were included (mean age: 71.2 ± 7.9; 64% male). Most patients presented with Rutherford class 3 (79.9%), followed by class 5 (12.7%), class 4 (10%) and class 6 (6.4%). The mean lesion length was 197.6 ± 108.5 mm and 74.3% of patients had chronic total occlusions. There were no differences in primary patency between the calcification scores at 12 months (PACSS, LogRank = 0.28; quadrants, LogRank = 0.29; PARC, LogRank = 0.42) and 24 months (PACSS, LogRank = 0.13; quadrants, LogRank = 0.42; PARC, LogRank = 0.13). FTLR was significantly lower at 12 months in patients with calcification affecting 3 or 4 quadrants (LogRank = 0.022) but not at 24 months (LogRank = 0.36). CONCLUSIONS: In this study, the Eluvia™ DES showed promising performance in calcified disease and the analysis according to the quadrant model predicted an increased risk for TLR at 12 months.


Assuntos
Stents Farmacológicos , Procedimentos Endovasculares , Artéria Femoral , Doença Arterial Periférica , Artéria Poplítea , Calcificação Vascular , Humanos , Masculino , Feminino , Idoso , Artéria Poplítea/diagnóstico por imagem , Artéria Femoral/diagnóstico por imagem , Estudos Retrospectivos , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/terapia , Doença Arterial Periférica/terapia , Doença Arterial Periférica/diagnóstico por imagem , Procedimentos Endovasculares/métodos , Resultado do Tratamento , Grau de Desobstrução Vascular , Polímeros , Pessoa de Meia-Idade , Idoso de 80 Anos ou mais
14.
Port J Card Thorac Vasc Surg ; 30(4): 75-79, 2024 Feb 09.
Artigo em Inglês | MEDLINE | ID: mdl-38345877

RESUMO

INTRODUCTION: Popliteal artery aneurysms (PAA) can be very challenging, especially in cases of very large PAAs, with a minimal number of case reports published in the literature. METHODS: This is a case report of a 68-year-old male patient with hypertension, hyperlipidemia, diabetes, and schizophrenia who was found to have a giant (10x8x6cm) partially thrombosed PAA, treated with interposition polytetrafluoroethylene (PTFE) graft via a posterior approach. RESULTS: Under general anesthesia, the patient was placed in a prone position, and an extended lazy "S" incision was made on the popliteal fossa. After obtaining proximal and distal exposure, the aneurysm sac was skeletonized, preserving the popliteal vein and the tibial nerve. After proximal and distal control was obtained, the patient was systemically heparinized, and the aneurysm sac was opened. Some genicular branches were ligated inside the aneurysm, and part of the aneurysm sac was excised. A 7 mm PTFE graft was used for reconstruction in an end-to-end fashion. Suction drains were placed in the popliteal space, and the fascia and skin were approximated. The patient was discharged home on the 2nd postoperative day on aspirin and statin with ultrasound surveillance. The patient has remained asymptomatic during follow-up with a patent graft. CONCLUSIONS: Open surgical repair constitutes the gold standard of care for huge PAAs to prevent distal thromboembolic events and mass pressure effects from the aneurysm. Documentation of additional experience with open repair of huge PAAs would be beneficial and could help clinical decision-making.


Assuntos
Aneurisma , Aneurisma da Artéria Poplítea , Masculino , Humanos , Idoso , Aneurisma/diagnóstico , Joelho , Extremidade Inferior , Politetrafluoretileno , Artéria Poplítea/diagnóstico por imagem
15.
Vascular ; 32(1): 32-41, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38308424

RESUMO

BACKGROUND: Popliteal artery aneurysms (PAA) were traditionally treated by open repair (OR). Endovascular repair (ER) has become a new treatment strategy. The aim of this systemic review and meta-analysis was to evaluate and compare the current outcomes of OR and ER in the emergency treatment of PAA. METHODS: A systematic literature search of the PubMed/Medline database was carried out. Outcomes were 30-day mortality, morbidity, major amputation rate (30 days), major amputation rate (1 year), 1-year primary patency rate, 1-year secondary patency rate and 1-year survival. Additionally, we included clinical data of patients with popliteal aneurysms treated between 2009 and 2021 at the Martin-Luther University Halle-Wittenberg. RESULTS: We identified two cohort studies from 2014 and 2015 with a total of 199 patients that underwent emergent surgery (39 ER and 160 OR). We also included 26 patients from our institution. For emergency treatment, 30-day major amputation rates (18% vs 3%, Odds Ratio 5.82, 95% CI [1.75; 19.30], p = .004), 30-day mortality rates (10% vs 1%, Odds Ratio 5.57, 95% CI [1.01; 30.58], p = .05), 1-year major amputation rates (15% vs 6% Odds Ratio 3.61, 95% CI [1.18; 11.09], p = .02), 1-year loss of primary patency (54% vs 23%, Odds Ratio 3.19, 95% CI [0.91; 11.20], p = .07), and 1-year loss of secondary patency (44% vs 12%, Odds Ratio 6.91, 95% CI [3.01; 15.83], p < .05) were higher in the ER group when compared to the OR group. CONCLUSION: Endovascular repair represents an alternative approach for the emergency treatment of PAA. Limited evidence from the available non-randomized studies shows unfavorable outcomes for patients undergoing ER. However, the results are prone to selection bias, and only randomized trials comparing ER to OR might reveal whether a subgroup of patients would benefit from ER as primary treatment of PAA in an emergency setting.


Assuntos
Aneurisma , Procedimentos Endovasculares , Aneurisma da Artéria Poplítea , Humanos , Grau de Desobstrução Vascular , Salvamento de Membro , Resultado do Tratamento , Aneurisma/diagnóstico por imagem , Aneurisma/cirurgia , Aneurisma/etiologia , Tratamento de Emergência , Estudos Retrospectivos , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/cirurgia , Fatores de Risco
17.
J Vasc Surg ; 79(5): 1142-1150.e2, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38190927

RESUMO

OBJECTIVE: The aim of this study was to report the results of a prospective, single-arm, registry-based study assessing the safety and performance of a paclitaxel drug-coated balloon (DCB) for the treatment of superficial femoral artery (SFA) or popliteal artery in-stent restenosis (ISR) in a United States population. METHODS: We conducted a prospective, non-randomized, multi-center, single-arm, post-market registry of the IN.PACT Admiral DCB for the treatment of ISR lesions in the SFA or popliteal artery at 43 sites within the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Registry from December 2016 to January 2020. Clinical outcomes were assessed at 12, 24, and 36 months. The primary endpoint was target lesion revascularization at 12 months. Secondary endpoints included technical success, target vessel revascularization, major limb amputation, and all-cause mortality. Results are presented as survival probabilities based on Kaplan-Meier survival estimates. RESULTS: Patients (N = 300) were 58% male, with a mean age of 68 ± 10 years. Diabetes was present in 56%, 80% presented with claudication, and 20% with rest pain. Lesions included ISR of the SFA in 68%, SFA-popliteal in 26%, and popliteal arteries in 7%. The mean lesion length was 17.8 ± 11.8 cm. Lesions were categorized as occlusions in 43% (mean occluded length, 16 ± 10 cm). TASC type was A (17%), B (29%), C (38%), and D (15%). Technical success was 99%. Re-stenting was performed in 5% and thrombolysis in 0.6% of patients. Kaplan-Meier estimates for freedom from target lesion revascularization were 90%, 72%, and 62% at 12, 24, and 36 months. Freedom from target vessel revascularization was 88%, 68%, and 59% and freedom from major target limb amputation was 99.6%, 98.9%, and 98.9%, respectively, at 12, 24, and 36 months. Survival was 95%, 89%, and 85% at 12, 24, and 36 months. CONCLUSIONS: This post-market registry-based study shows promising results in treating femoral-popliteal ISR with paclitaxel DCB in comparison to the results of plain balloon angioplasty reported in the literature. These results demonstrate the ability of the SVS VQI to conduct post-market evaluation of peripheral devices in partnership with industry and federal regulators.


Assuntos
Angioplastia com Balão , Reestenose Coronária , Doença Arterial Periférica , Humanos , Masculino , Pessoa de Meia-Idade , Idoso , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Poplítea/diagnóstico por imagem , Paclitaxel/efeitos adversos , Estudos Prospectivos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Salvamento de Membro , Fatores de Tempo , Constrição Patológica , Sistema de Registros , Materiais Revestidos Biocompatíveis , Resultado do Tratamento
18.
J Vasc Surg ; 79(5): 1163-1169.e2, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38244642

RESUMO

OBJECTIVE: The infrageniculate popliteal artery is a potential source for inflow in lower extremity bypass surgery in patients with isolated tibial artery disease. The objective of our study was to assess the short- and long-term outcomes of popliteal-distal bypasses using data from the Vascular Quality Initiative (VQI). METHODS: The VQI registry was queried between 2003 and 2021 for patients undergoing surgical revascularizations with the below-knee popliteal artery serving as inflow. Demographics, comorbidities, intraoperative characteristics, and postoperative complications were analyzed. Kaplan-Meier models were used to estimate amputation-free survival, survival, and freedom from amputation. Cox regression analysis was conducted to determine factors associated with major amputation or death. RESULTS: A total of 1884 procedures were analyzed. The mean age of the included patients was 67.7 years. The most frequently observed preoperative comorbidities included insulin-dependent diabetes (52.3%), coronary disease (32.4%), and end-stage renal disease (14.4%). Of all the patients, 670 (35.6%) had a history of ipsilateral endovascular intervention. The procedures were performed for a variety of indications, including tissue loss (84.3%), rest pain (10.9%), and claudication (4.8%). Intraoperatively, the outflow targets were the dorsalis pedis (31.4%), the posterior tibial (24.4%), and the anterior tibial arteries (15.6%). Vein conduit was used in 92.1% of cases. The rate of perioperative myocardial infarction (MI) was 2.4%, and the 30-day mortality was 1.9%. The median length of follow up was 371 days. Amputation-free survival was found to be 85.6% (95% confidence interval [CI], 84.0%-87.2%) at 6 months and 78.6% (95% CI, 76.6%-80.4%) at 12 months. Survival was found to be 93.4% (95% CI, 92.2%-94.5%) at 6 months and 88.6% (95% CI, 87.1%-90.0%) at 12 months. Freedom from amputation was found to be 92.0% (95% CI, 90.7%-93.3%) at 6 months and 89.0% (95% CI, 87.3%-90.4%) at 12 months. Cox regression analysis demonstrated that age greater than 65 years, congestive heart failure, coronary artery disease, and end-stage renal disease were associated with a higher risk of major amputation or death (P < .05). CONCLUSIONS: Below-knee popliteal-distal bypass is a safe and effective approach to treat severe tibial vessel occlusive disease in this challenging patient cohort. Patients exhibited low perioperative complication rates and good amputation-free survival at 1 year.


Assuntos
Isquemia , Falência Renal Crônica , Humanos , Idoso , Resultado do Tratamento , Isquemia/cirurgia , Grau de Desobstrução Vascular , Salvamento de Membro , Extremidade Inferior/irrigação sanguínea , Amputação Cirúrgica , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/cirurgia , Estudos Retrospectivos , Fatores de Risco
19.
Cardiovasc Intervent Radiol ; 47(2): 177-185, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38228879

RESUMO

PURPOSE: To investigate the long-term results of the Eluvia drug-eluting stent (DES) implantation for femoropopliteal arterial disease, including the 'halo' phenomenon. Long-term data of DES is scarce. A focal reaction ('halo') following Eluvia DES deployment has been described. However, the long-term clinical impact of this phenomenon remains unclear. METHODS: This prospective, non-randomized, single-arm study included 130 consecutive patients treated with an Eluvia DES for symptomatic femoropopliteal disease between March 2016 and December 2018. Clinical outcomes and imaging were assessed after 6 months and annually thereafter for up to 5 years. The primary outcome measure was primary patency. Secondary outcomes were freedom from clinically driven target lesion revascularization (CD-TLR), freedom from major amputation, overall survival and amputation-free survival rates. RESULTS: The primary patency was 65% at 5 years. The freedom from CD-TLR and from major amputation at 5 years was 79 and 96%, respectively. The overall survival and amputation-free survival rates were 88 and 83% at 60 months, respectively. Out of the 27 patients with a halo sign, two showed an increased (7.4%) and 6 (22.2%) a decreased diameter. In 19 cases (70.4%), the diameter remained unchanged at the latest follow-up. The presence of the 'halo' sign was associated with increased primary patency (87% versus 59%, HR: 2.48, 95%CI 1.19-5.16, P = .015). CONCLUSIONS: The presented patient cohort treated with the Eluvia DES for femoropopliteal artery lesions indicates durable efficacy and a good safety profile regardless of the halo phenomenon. The results need to be confirmed in a larger patient cohort. LEVEL OF EVIDENCE III: Non-randomized controlled cohort/follow-up study.


Assuntos
Stents Farmacológicos , Doença Arterial Periférica , Humanos , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/patologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/patologia , Seguimentos , Resultado do Tratamento , Paclitaxel/uso terapêutico , Estudos Prospectivos , Polímeros , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Grau de Desobstrução Vascular
20.
J Vasc Surg ; 79(3): 623-631.e2, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-37951514

RESUMO

OBJECTIVE: There is a lack of consensus regarding the optimal strategy for evaluating the efficiency and safety of dual-pathway inhibition (DPI) in preventing femoropopliteal restenosis in patients undergoing repeated endovascular interventions. Despite several therapeutic interventions available for preventing femoropopliteal restenosis post repeated endovascular interventions, the ideal strategy, particularly evaluating the efficacy and safety of DPI, remains a matter of debate. METHODS: From January 2015 to September 2021, patients who underwent repeated endovascular interventions for femoropopliteal restenosis were compared with those who underwent DPI or dual antiplatelet therapy (DAPT) after surgery using a propensity score-matched analysis. The primary outcome was clinically driven target lesion revascularization (CD-TLR). The principal safety outcome was a composite of major bleeding and clinically relevant non-major (CRNM) bleeding. To further enhance the rigor, Kaplan-Meier plots, Cox proportional hazards modeling, and sensitivity analyses, as well as subgroup analyses were employed, reducing potential confounders. RESULTS: A total of 441 patients were included in our study, of whom 294 (66.7%) received DAPT and 147 (33.1%) received DPI, with 114 matched pairs (mean age, 72.21 years; 84.2% male). Cumulative probability of CD-TLR at 36 months in the DPI group (17%) trended lower than that in the DAPT group (32%) (hazard ratio [HR], 0.45; 95% confidence interval [CI], 0.26-0.78; P =.004). The cumulative probability of freedom from CD-TLR at 36 months in the DPI group was 83%. No significant difference was observed in the composite outcome of major or CRNM bleeding between the DPI and DAPT groups (HR, 1.26; 95% CI, 0.34 to 4.69; P = .730). The DPI group was associated with significantly lower rates of CD-TLR in the main subgroup analyses of diabetes (P = .001), previous smoking history (P = .008), longer lesion length (>10 cm) (P = .003), and treatment with debulking strategy (P = .003). CONCLUSIONS: In our investigation focused on CD-TLR, we found that DPI exhibited a significant reduction in the risk of reintervention compared with other treatment modalities. This underscores the potential of DPI as a viable therapeutic strategy in preventing reinterventions. Moreover, our assessment of safety outcomes revealed that the bleeding risks associated with DPI were on par with DAPT, thereby not compromising patient safety. These findings pave the way for potential broader clinical implications, emphasizing the effectiveness and safety of DPI in the context of reducing reintervention risks.


Assuntos
Angioplastia com Balão , Doença Arterial Periférica , Humanos , Masculino , Idoso , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/patologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/cirurgia , Artéria Poplítea/patologia , Inibidores da Agregação Plaquetária/efeitos adversos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Doença Arterial Periférica/patologia , Resultado do Tratamento , Grau de Desobstrução Vascular , Fatores de Risco
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