RESUMO
BACKGROUND: Endovascular therapy has become established as a first-line therapy in most arterial regions. However, open vascular surgery (endarterectomy) remains the treatment of choice for common femoral artery (CFA) lesions. The aim of this study is to investigate the acute and mid-term results of directional atherectomy plus drug-coated balloon (DCB) in comparison to endarterectomy in treatment of de novo arteriosclerotic CFA lesions. METHODS: This prospective, randomized, multicenter non-inferiority study will enroll 306 participants with symptomatic (Rutherford category 1 to 5) de novo stenosis of the CFA including the bifurcation. Patients eligible for both treatment groups could be included in this 1:1 randomized trial. Primary efficacy endpoint is patency of the target lesion at 12 months defined as restenosis < 50% without the need of clinically driven target lesion revascularization (cdTLR). Primary safety endpoint is a combined endpoint including death, myocardial infarction, major or minor amputation of the target limb, and peri-procedural complications at 30 days. Secondary endpoints include primary patency of the target lesion at 6 and 24 months, secondary patency, cdTLR 6, 12, and 24 months, change in ankle-brachial index, and Rutherford-Becker class at 6, 12, and 24 months. Limb salvage, change in quality of life measured by Walking Impairment Questionnaire, and major adverse events including death, myocardial infarction, and minor or major amputation of the target limb will be determined at 6, 12, 24, and 36 months. DISCUSSION: Endovascular treatment of CFA lesions is still a matter of debate. Few studies compared modern endovascular therapy methods against the so-called gold standard surgical endarterectomy so far. Based on recent positive results, this study aims to confirm non-inferiority of a "leaving nothing behind" endovascular approach combining directional atherectomy and DCB compared to surgical therapy. TRIAL REGISTRATION: ClinicalTrials.gov NCT02517827.
Assuntos
Endarterectomia , Artéria Femoral , Doença Arterial Periférica , Grau de Desobstrução Vascular , Humanos , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/métodos , Angioplastia com Balão/instrumentação , Aterectomia/efeitos adversos , Aterectomia/métodos , Materiais Revestidos Biocompatíveis , Endarterectomia/efeitos adversos , Endarterectomia/métodos , Estudos de Equivalência como Asunto , Artéria Femoral/cirurgia , Salvamento de Membro , Estudos Multicêntricos como Assunto , Doença Arterial Periférica/terapia , Doença Arterial Periférica/cirurgia , Doença Arterial Periférica/fisiopatologia , Estudos Prospectivos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Tempo , Resultado do Tratamento , Dispositivos de Acesso VascularAssuntos
Aterectomia , Artéria Femoral , Artéria Poplítea , Calcificação Vascular , Humanos , Artéria Femoral/diagnóstico por imagem , Artéria Poplítea/diagnóstico por imagem , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/terapia , Aterectomia/métodos , Masculino , Idoso , Tomografia de Coerência Óptica/métodos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Doença Arterial Periférica/cirurgia , FemininoAssuntos
Angioplastia com Balão , Aterectomia , Artéria Femoral , Doença Arterial Periférica , Artéria Poplítea , Humanos , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/cirurgia , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/cirurgia , Angioplastia com Balão/instrumentação , Aterectomia/métodos , Resultado do Tratamento , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Doença Arterial Periférica/cirurgia , Recidiva , Masculino , Lasers de Excimer/uso terapêutico , Stents , Idoso , Feminino , Materiais Revestidos Biocompatíveis , Grau de Desobstrução Vascular , Dispositivos de Acesso Vascular , Pessoa de Meia-IdadeRESUMO
This study evaluated the outcomes of a bare metal stent (BMS), DCB alone, atherectomy plus a drug-coated balloon (AT + DCB) and AT alone for the treatment of femoropopliteal artery occlusion. Four groups were included in this retrospective cohort study: 119 patients underwent the BMS procedure, 89 patients underwent DCB alone, 52 patients underwent AT + DCB, and 61 patients underwent AT alone. Patients were followed-up at 1, 6, 12 and 24 months after the procedure, the clinical outcomes and complications were assessed, and the primary outcomes were primary patency and restenosis. AT + DCB showed a lower bailout stent, and BMS displayed a higher retrograde puncture, flow-limiting dissection and postdilation (p < 0.05). For all procedures, the walking distance, ABI and pain score post-procedure were significantly improved compared with the pre-procedure values (p < 0.001). The restenosis rate was higher in BMS (21.0%) and AT alone (24.6%) than in DCB (10.1%) alone and AT + DCB (11.5%) (p = 0.04); there was no difference in amputation or clinically driven target lesion revascularization among procedures. The primary patency rates were 77.7%, 89.4%, 88.0% and 73.7% in the BMS, DCB alone, AT + DCB and AT alone groups at 24 months, respectively (p = 0.03), while the secondary patency and main adverse events (stroke, MI and death) were similar. Proximal concavity, proximal target vessel diameter ≥ 5 mm, runoff number ≥ 2 and DCB use were protective factors for primary patency. Our results suggested that AT + DCB and DCB alone were associated with higher primary patency, and DCB devices (combined with/without AT) should be the preferred choice for FP lesions.
Assuntos
Angioplastia com Balão , Doença Arterial Periférica , Humanos , Artéria Femoral/cirurgia , Artéria Poplítea/cirurgia , Doença Arterial Periférica/cirurgia , Doença Arterial Periférica/etiologia , Estudos Retrospectivos , Resultado do Tratamento , Fatores de Risco , Materiais Revestidos Biocompatíveis , Grau de Desobstrução Vascular , Angioplastia com Balão/efeitos adversos , Stents/efeitos adversos , Aterectomia/efeitos adversos , Aterectomia/métodosRESUMO
OBJECTIVE: We evaluated the midterm results of atherectomy-assisted angioplasty for the treatment of femoropopliteal lesions and the identification of possible subgroups of patients with superior outcomes. METHODS: We conducted a single-center, physician-initiated, nonindustry-sponsored retrospective analysis of patients with Rutherford category ranging from II to V and de novo occlusive or stenotic lesions of the superficial femoral (SFA) and/or popliteal arteries treated with atherectomy-assisted angioplasty (Jetstream rotational atherectomy + drug-eluting ballooning). In cases of subintimal recanalization or patients without an SFA stamp, with previous ipsilateral bypass surgery, systemic coagulopathy, end-stage renal disease requiring hemodialysis, life expectancy of <12 months, and intolerance to aspirin, clopidogrel, and/or heparin were excluded. RESULTS: In a total of 103 enrolled patients, the median SFA and/or popliteal lesion length was 80 mm (interquartile range, 61.2 mm) with 73 lesions being occlusive (70.9%) and 84 (81.5%) classified as Fanelli calcification score 3 and 4. Technical success was met in 96.1% of cases (n = 99) at a median operative time of 108 minutes. Adjunctive stenting was needed in 10 patients (9.8%). At a median follow-up of 18.0 ± 10.8 months, Rutherford class clinical improvement was present in 77 patients (74.8%), and 7 patients (6.79%) presented target lesion occlusion needing reintervention in 6 cases (5.82%). The primary patency rates were 97% at 12 months and 83% at 24 months with secondary patency rates of 99% at 12 months and 91% at 24 months of follow-up. There were no significant differences when treating differently located lesions, diabetic vs nondiabetic patients, or comparing experienced vs nonexperienced operators. CONCLUSIONS: The use of rotational atherectomy and drug-eluting balloons for the treatment of severe femoropopliteal disease showed relatively low need for bailout stenting and good midterm primary patency rates. The influence of lesion location, diabetes mellitus, or operator experience did not show statistically different results in terms of patency. Longer term outcomes and comparative analysis are needed to consolidate further clinical evidence.
Assuntos
Angioplastia com Balão , Aterectomia Coronária , Doença Arterial Periférica , Humanos , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/cirurgia , Estudos Retrospectivos , Resultado do Tratamento , Angioplastia com Balão/efeitos adversos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/cirurgia , Aterectomia/efeitos adversos , Aterectomia/métodos , Grau de Desobstrução VascularRESUMO
BACKGROUND: There is a paucity of real-world data on the in-hospital (IH) and post-discharge outcomes in patients undergoing lower extremity peripheral vascular intervention (PVI) with adjunctive atherectomy. AIMS: In this retrospective, registry-based study, we evaluated IH and post-discharge outcomes among patients undergoing PVI, treated with or without atherectomy, in the National Cardiovascular Data Registry PVI Registry. METHODS: The IH composite endpoint included procedural complications, bleeding or thrombosis. The primary out-of-hospital endpoint was major amputation at 1 year. Secondary endpoints included repeat endovascular or surgical revascularisation and death. Multivariable regression was used to identify predictors of atherectomy use and its association with clinical endpoints. RESULTS: A total of 30,847 patients underwent PVI from 2014 to 2019, including 10,971 (35.6%) treated with atherectomy. The unadjusted rate of the IH endpoint occurred in 524 (4.8%) of the procedures involving atherectomy and 1,041 (5.3%) of non-atherectomy procedures (p=0.07). After adjustment, the use of atherectomy was not associated with an increased risk of the combined IH endpoint (p=0.68). In the 6,889 (22.4%) patients with out-of-hospital data, atherectomy was associated with a reduced risk of amputation (adjusted hazard ratio [aHR] 0.67, 95% confidence interval [CI]: 0.51-0.85; p<0.01) and surgical revascularisation (aHR 0.63, 95% CI: 0.44-0.89; p=0.017), no difference in death rates (p=0.10), but an increased risk of endovascular revascularisation (aHR 1.21, 95% CI: 1.06-1.39; p<0.01) at 1 year. CONCLUSIONS: The use of atherectomy during PVI is common and is not associated with an increase in IH adverse events. Longitudinally, patients treated with atherectomy undergo repeat endovascular reintervention more frequently but experience a reduced risk of amputation and surgical revascularisation.
Assuntos
Procedimentos Endovasculares , Doença Arterial Periférica , Humanos , Estudos Retrospectivos , Assistência ao Convalescente , Procedimentos Endovasculares/efeitos adversos , Fatores de Risco , Resultado do Tratamento , Alta do Paciente , Aterectomia/efeitos adversos , Aterectomia/métodos , Extremidade Inferior/irrigação sanguínea , Extremidade Inferior/cirurgiaRESUMO
Catheter-based atherectomy has been discussed for some years, although the conclusions have been controversial. Recent study data did show the feasibility of multifunctional atherectomy devices for complex lesion morphologies, with moderate material use. This is then thus an alternative to bypass surgery, although a direct comparison is lacking.The results of the ByCross approval study were compared to technical and clinical data from various atherectomy systems in terms of range of indication, limitations as defined by the manufacturer, the success and complication rate and the instructions for use. As in many recent studies, a residual stenosis ≤ 50% after atherectomy and ≤ 30% in the completion imaging was defined as the primary endpoint and proof of technical success.Lesions recruited for the ByCross study were more complex than in other studies, with respect to the lesion length (124.7 mm vs. 34 mm in the EASE study and 67.2 mm in the VISION study) and the degree of stenosis (99.4% vs. 88.5% in the EASE and 78,7% in the VISION study). Calcification was also more severe - as defined by the PACSS (Peripheral Artery Calcification Severity Score). ByCross allowed recanalisation of lesions without wire passage prior to atherectomy (26.82%), which is a must for all other systems. The variable tip diameter of the ByCross can achieve a lumen gain of 4.7 mm without tip or wire exchange or run time limits. The 0% rate of embolic events, which is unique for atherectomy device approval studies, can be explained by the working principle and the high aspiration rate. No vessel injuries occurred, and the 6-month follow-up results showed 0% revascularisation rate.New generation atherectomy systems offer safe and effective enlargement of the endovascular portfolio. The ByCross device is an atherectomy, thrombectomy and crossing device free from investment and has a wider range of indications for the iliac and the femorodistal segments, which supports ByCross atherectomy as an alternative for bypass surgery.
Assuntos
Aterectomia , Humanos , Resultado do Tratamento , Constrição Patológica , Aterectomia/métodosRESUMO
BACKGROUND: Peripheral artery disease (PAD) is associated with high morbidity and mortality, particularly once patients develop critical limb threatening ischemia (CLTI). Minorities and vulnerable populations often present with CLTI and experience worse outcomes. The use of directional atherectomy (DA) and drug-coated balloon (DCB) during lower-extremity revascularization (LER) has not been previously described in a safety-net population. OBJECTIVE: To review demographic and clinical characteristics, and short- intermediate term outcomes of patients presenting to a safety-net hospital with PAD treated with DA and DCB during LER. METHODS: In this retrospective, observational cohort study, chart review was performed of all patients who underwent DA and DCB during LER for PAD from April 2016 to January 2020 in a safety-net hospital. RESULTS: The analysis included 58 patients, with 41% female, 24% Black/African American, and 31% Hispanic. From this group, 17% spoke a non-English primary language and 10% reported current or previous housing insecurity. Most (65%) presented with CLTI and had undergone a previous index leg LER (58%). The combination of DA and DCB was efficacious, resulting in low rates of bail-out stenting (16%) and target-vessel revascularization (26%) at 2 years. Low complication rates (tibial embolism in 12% and vessel perforation in 2% of cases) were also observed. Most patients (67%) with Rutherford category 5 experienced wound healing by 2 years. CONCLUSION: In this safety-net population, the majority presented with CLTI and a previous LER of the index leg. The combination of DA and DCB resulted in low complication rates, and good short-intermediate outcomes in this frequently undertreated population.
Assuntos
Angioplastia com Balão , Doença Arterial Periférica , Humanos , Feminino , Masculino , Estudos Retrospectivos , Artéria Femoral , Artéria Poplítea , Resultado do Tratamento , Fatores de Risco , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/cirurgia , Aterectomia/efeitos adversos , Aterectomia/métodos , Grau de Desobstrução Vascular , Materiais Revestidos BiocompatíveisRESUMO
INTRODUCTION: This study is an analysis of the therapeutic effects of directional atherectomy combined with drug-coated balloon angioplasty (DA+DCB) in treating superficial femoral arteriosclerosis obliterans. METHODS: Patients in our hospital with superficial femoral arteriosclerosis obliterans who received DA+DCB during the period June 2016 to February 2019 were identified retrospectively. Preoperative demographics, operative details and postoperative follow-up outcomes were analysed statistically. RESULTS: Between June 2016 and February 2019, 48 patients were enrolled in this retrospective study. The average age of the patients was 66.85 ± 11.28 years; 83.3% of the patients were male. During the procedure, flow-limiting dissection occurred frequently (9/48 patients) and there were six bailout stent implantations owing to flow-limiting dissections. The incidence rate of target artery thrombosis was 4.2% (2/48). There was no vessel perforation, embolism or operation-related death. The technical success rate was estimated at 100%. The mean ankle-brachial index of the patients was 0.54 ± 0.28 before the operation and 0.93 ± 0.13 before discharge (p < 0.0001). The mean follow-up time was 19.6 ± 9.0 months. The primary patency rate was 89.4%, 82.4% and 76.5% at 12, 24 and 36 months. The freedom from target lesion revascularisation (TLR) was 97.9%, 93.8% and 84.4% at 12, 24 and 36 months. CONCLUSION: The use of DA+DCB showed good clinical benefit for superficial femoral arteriosclerosis obliterans, which had good primary patency and freedom from TLR. Multicentre randomised controlled trials with long-term follow-up are needed.
Assuntos
Angioplastia com Balão , Arteriosclerose Obliterante , Doença Arterial Periférica , Dispositivos de Acesso Vascular , Humanos , Masculino , Pessoa de Meia-Idade , Idoso , Feminino , Artéria Femoral/cirurgia , Artéria Poplítea , Estudos Retrospectivos , Doença Arterial Periférica/cirurgia , Arteriosclerose Obliterante/cirurgia , Resultado do Tratamento , Fatores de Risco , Fatores de Tempo , Materiais Revestidos Biocompatíveis , Grau de Desobstrução Vascular , Angioplastia com Balão/efeitos adversos , Aterectomia/efeitos adversos , Aterectomia/métodosRESUMO
BACKGROUND: The use of atherectomy during peripheral endovascular interventions (PVI) has increased dramatically, but data regarding its safety and effectiveness are lacking. Aims: This study sought to determine the long-term safety of atherectomy in contemporary practice. Methods: Medicare fee-for-service beneficiaries who underwent femoropopliteal artery PVI from 2015-2018 were identified in a 100% sample of inpatient, outpatient, and carrier file data using procedural claims codes. The primary exposure was the use of atherectomy. Inverse probability of treatment weighting was used to adjust for measured differences in patient populations. Kaplan-Meier methods and multivariable Cox proportional hazards regression were used to compare outcomes. Results: Among 168,553 patients who underwent PVI, 59,142 (35.1%) underwent atherectomy. The mean patient age was 77.0±7.6 years, 44.9% were female, 81.9% were white, and 46.7% had chronic limb-threatening ischaemia. Over a median follow-up time of 993 days (interquartile range 319-1,377 days), atherectomy use was associated with no difference in the risk of either the composite endpoint of death and amputation (adjusted hazard ratio [aHR] 0.99, 95% confidence interval [CI]: 0.97-1.01; p=0.19) or of major adverse limb events (aHR 1.02, 95% CI: 0.99-1.05; p=0.26). Patients who underwent atherectomy had a modest reduction in the risk of subsequently undergoing amputation or surgical revascularisation (aHR 0.92, 95% CI: 0.90-0.94; p<0.01) but an increase in the risk of undergoing a subsequent PVI (aHR 1.19, 95% CI: 1.16-1.21; p<0.01). CONCLUSIONS: The use of atherectomy during femoropopliteal artery PVI was not associated with an increase in the risk of long-term adverse safety outcomes among patients with peripheral artery disease.
Assuntos
Procedimentos Endovasculares , Doença Arterial Periférica , Humanos , Feminino , Idoso , Estados Unidos , Idoso de 80 Anos ou mais , Masculino , Resultado do Tratamento , Fatores de Risco , Medicare , Aterectomia/efeitos adversos , Aterectomia/métodos , Artéria Femoral/cirurgia , Doença Arterial Periférica/cirurgia , Estudos Retrospectivos , Procedimentos Endovasculares/efeitos adversosRESUMO
OBJECTIVES: This study aims to report the efficacy and safety of new atherectomy methods using the Crosser system for calcified lesions in the common femoral and popliteal artery: the Crosser system supported by bended 0.014 wire (Crossbow) technique and retrograde approach of sheathless Crosser system supported by bended 0.014 wire (Rambow) technique. MATERIALS AND METHODS: This report describes a single-center, retrospective study. A total of 23 patients (mean ± SD age, 73 ± 10 years; 19 men) with symptomatic peripheral artery disease received the Crossbow technique and Rambow technique for treatment of calcified common femoral and popliteal disease; these patients were enrolled between October 2013 and October 2015. The primary efficacy outcome was acute technical success, defined as achievement of residual stenosis < 30% for stenting and < 50% for angioplasty or atherectomy. The primary safety outcome was assessed on the basis of angiographic complications. RESULTS: The Crossbow and Rambow techniques were undertaken in 100% and 17% of the patients, respectively. Acute technical success was achieved in 96% of the patients. There were two embolic events. CONCLUSION: Crossbow and Rambow techniques could be effective atherectomy methods of calcified common femoral and popliteal disease. Regarding safety, embolic protection devices may be needed for our atherectomy methods.
Assuntos
Angioplastia com Balão , Doença Arterial Periférica , Masculino , Humanos , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Artéria Femoral/diagnóstico por imagem , Estudos Retrospectivos , Angioplastia com Balão/efeitos adversos , Artéria Poplítea/diagnóstico por imagem , Aterectomia/métodos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Resultado do Tratamento , Grau de Desobstrução VascularRESUMO
INTRODUCTION: It has been reported that excimer laser atherectomy combined with a drug-coated balloon (ELA+DCB) can achieve better results than simple balloon angioplasty, especially for the treatment of femoropopliteal in-stent restenosis. However, reports on the application of ELA+DCB in China for femoropopliteal arteriosclerosis obliterans are lacking. This study focuses on analysing the effectiveness and safety of ELA+DCB. METHODS: This was a single-centre retrospective study that enrolled patients from November 2016 to January 2019 who had femoropopliteal arteriosclerosis obliterans treated by ELA+DCB. Preoperative demographics, operative details and postoperative follow-up outcomes were analysed statistically. RESULTS: There were 43 patients with an average patient age of 68.0±8.6 years; 79.1% were male. In 30 cases, the lesions were de novo and the others were in-stent restenosis (ISR). During the procedure, flow-limiting dissection (48.8%) was the main adverse event and there were 17 bailout stent implantations due to dissection. Mean (±sd) ankle-brachial index (ABI) in the patients was 0.42±0.31 before the operation and 0.83±0.13 before discharge. The mean (±sd) follow-up time was 29.35±9.71 months. The primary patency rate was 66.8%, 64.3% and 60.9% at 12, 24 and 36 months. Freedom from target lesion revascularisation (TLR) was 85.7%, 80.7% and 75.3% at 12, 24 and 36 months. Rutherford categories also greatly improved during follow-up. Overall mortality was 6.9% (3/48), and no deaths were related to the intervention. CONCLUSION: The use of ELA+DCB had good clinical benefit for femoropopliteal arteriosclerosis obliterans, which had good primary patency and freedom from TLR, although intraoperative complications still required attention. Multicentre randomised controlled trials with long-term follow-up are needed.
Assuntos
Angioplastia com Balão , Arteriosclerose Obliterante , Reestenose Coronária , Doença Arterial Periférica , Humanos , Masculino , Pessoa de Meia-Idade , Idoso , Feminino , Artéria Poplítea/cirurgia , Arteriosclerose Obliterante/cirurgia , Arteriosclerose Obliterante/etiologia , Lasers de Excimer/uso terapêutico , Estudos Retrospectivos , Reestenose Coronária/etiologia , Doença Arterial Periférica/cirurgia , Grau de Desobstrução Vascular , Aterectomia/efeitos adversos , Aterectomia/métodos , Artéria Femoral/cirurgia , Angioplastia com Balão/efeitos adversos , Constrição Patológica/etiologia , Resultado do Tratamento , Materiais Revestidos BiocompatíveisRESUMO
PURPOSE: To evaluate liver function improvement and volume gain after percutaneous recanalization of chronic portal vein thrombosis (PVT) in non-cirrhotic patients. MATERIALS AND METHODS: In this retrospective study, five non-cirrhotic participants between 21 and 67 years old with secondary chronic PVT (4-21 years from diagnose) were submitted to percutaneous portal vein recanalization, followed by varices and shunts embolization. RESULTS: After a mean of 12.6 months, all portal veins remained patent and there was complete resolution of portal hypertension (PH) symptoms in all participants. There was a significant increase in liver volume of 39.8 ± 19.0% (p = 0.042), platelets count of 53120 ± 20188/µl (p = 0.042), and a significant decrease in total bilirubin levels from 1.04 ± 0.23 mg/dL to 0.51 ± 0.09 mg/dL (p = 0.043). We also found a non-significant increase in albumin levels from 3.88 ± 0.39 g/dL to 4.38 ± 0.27 g/dL (p = 0.078) and decrease in spleen diameter from 16.88 ± 4.03 cm to 14.15 ± 2.72 cm (p = 0.068). DISCUSSION: In this retrospective study, even with a small number of participants, we were capable of showing a median of 39.8% increase in liver volume, laboratorial liver function improvement, platelets count and resolution of PH symptoms, including gastroesophageal varices disappearance after portal vein recanalization followed by shunt embolization. CONCLUSION: In this small series of cases, recanalization of chronic PVT in non-cirrhotic participants was feasible, successful and safe despite the prolonged time of occlusion. This is a new and promising approaching to an old and still challenging disease.
Assuntos
Aterectomia/métodos , Hipertensão Portal , Fígado/fisiologia , Veia Porta/fisiologia , Derivação Portossistêmica Transjugular Intra-Hepática , Trombose Venosa/terapia , Adulto , Idoso , Humanos , Hipertensão Portal/complicações , Hipertensão Portal/patologia , Fígado/crescimento & desenvolvimento , Pessoa de Meia-Idade , Veia Porta/patologia , Estudos Retrospectivos , Resultado do Tratamento , Trombose Venosa/complicações , Trombose Venosa/diagnóstico por imagem , Adulto JovemRESUMO
OBJECTIVE: In this study, we aimed to describe the immediate and long-term vascular effects of OAS in patients with peripheral arterial disease (PAD) and moderate to severely calcified lesions. BACKGROUND: Debulking the calcified atherosclerotic plaque with the orbital atherectomy system (OAS) can potentially enhance vessel compliance and increase the chance of reaching a desirable angioplasty result. METHODS: A total of 7 patients were evaluated both at baseline and at 6-month follow-up. Following a diagnostic peripheral angiogram, patients with significant SFA disease had a baseline intravascular optical coherence tomography (IV-OCT) and the lesion was treated with OAS. Repeat IV-OCT was performed after atherectomy and after drug-coated balloon, if used. Patients were also evaluated with angiography and IV-OCT imaging at their 6-month follow-up. RESULTS: The majority of tissue removed was fibrous tissue. During follow-up, luminal volume increased for 4 of the 7 patients from baseline to 6-month follow-up and decreased in 3 patients. On average there was a 6% increase of luminal volume (P<.01 compared with baseline). A recent virtual histology algorithm was used for automatic classification of IV-OCT images unaided by any reader. The algorithm used convolutional neural networks to identify regions as either calcium, fibrous, or lipid plaque, and it agreed with an expert reader 82% of the time. CONCLUSION: To the best of our knowledge, the current report is the first to describe vascular effects of OAS in medial calcified lesions immediately after and at follow-up using IV-OCT in patients with severe PAD.
Assuntos
Aterectomia Coronária , Doença da Artéria Coronariana , Doença Arterial Periférica , Placa Aterosclerótica , Calcificação Vascular , Aterectomia/métodos , Aterectomia Coronária/efeitos adversos , Doença da Artéria Coronariana/terapia , Humanos , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/cirurgia , Placa Aterosclerótica/diagnóstico por imagem , Placa Aterosclerótica/cirurgia , Fatores de Tempo , Resultado do Tratamento , Calcificação Vascular/diagnóstico , Calcificação Vascular/cirurgiaRESUMO
PURPOSE: Optimal balloon angioplasty for infrapopliteal lesions is often limited by severe calcification, which has been associated with decreased procedural success and lower long-term patency. MATERIALS AND METHODS: This was a prospective, randomized, multicenter pilot trial that included adult subjects with calcified lesions located from the popliteal segment below the knee (BTK) joint to within 5 cm above the ankle with ≥70% diameter stenosis by angiography. Patients were randomized 1:1 to undergo orbital atherectomy (OA) with adjunctive drug-coated balloon (DCB) angioplasty versus plain balloon angioplasty (BA) and DCB angioplasty (control). The periprocedural and 12 month outcomes of both procedures were compared. RESULTS: Overall, 66 subjects (OA + DCB = 32 vs control = 34) were included in an intention to treat analysis. Baseline demographics and lesion characteristics were well-balanced. The mean lesion length was 101.3 mm (SD = 72.8 mm) and 78.8 (SD = 61.0 mm) in the OA + DCB and control groups, respectively, with almost all lesions having severe calcification per the Peripheral Academic Research Consortium (PARC) criteria. Chronic total occlusions (CTOs) were present in 43.8% and 35.3% of the patients in the OA + DCB and control groups, respectively. The technical success of OA + DCB versus DCB was 81.8% and 89.2%, respectively, with 3 slow flow/no reflow, 1 perforation, 1 severe dissection occurred in OA + DCB group, and one distal embolization occurred in the control group. The target lesion primary patency rate was numerically higher in the OA + DCB versus control group at 6 (88.2% vs 50.0%, p=0.065) and 12 month follow-up (88.2% vs 54.5%, p=0.076). The 12 month freedom from major adverse events, clinically-driven target lesion revascularization, major amputation, and all-cause mortality rates were similar between both groups. CONCLUSION: The results of the Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified BTK (OPTIMIZE BTK) pilot study indicated that utilization of OA + DCB is safe for infrapopliteal disease. Further prospective adequately powered studies should investigate the potential benefit of combined OA + DCB for BTK lesions.
Assuntos
Angioplastia com Balão , Doença Arterial Periférica , Adulto , Humanos , Projetos Piloto , Artéria Poplítea/diagnóstico por imagem , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Grau de Desobstrução Vascular , Materiais Revestidos Biocompatíveis , Resultado do Tratamento , Fatores de Tempo , Aterectomia/efeitos adversos , Aterectomia/métodos , Angioplastia com Balão/efeitos adversos , Artéria FemoralAssuntos
Aterectomia Coronária , Doença da Artéria Coronariana , Calcificação Vascular , Aterectomia/métodos , Aterectomia Coronária/efeitos adversos , Aterectomia Coronária/métodos , Angiografia Coronária/métodos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Humanos , Resultado do Tratamento , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/cirurgiaRESUMO
BACKGROUND: Currently, there is little information on the optimal treatment for patients with femoropopliteal total in-stent occlusion.The aim of this study was to evaluate the benefit of drug-coated balloon(DCB) angioplasty after RotarexâS rotational atherectomy plus thrombectomy for femoropopliteal total in-stent occlusion at 12 months. METHODS: From June 2016 to April 2019, 36 patients (21 male, mean age 71.1 ± 8.2 years) with femoropopliteal total in-stent occlusion were treated using Rotarex S rotational atherectomy plus thrombectomy in combination with DCB angioplasty and 29 (18 male, meanage68.8 ± 7.2 years) underwent DCB angioplasty alone. Primary patency and freedom from target lesion revascularization (TLR) rates during12 months of follow-up were retrospectively compared between the 2 groups. RESULTS: Procedural success was achieved in all patients. There were no procedure-related adverse events. The mean lesion length was 26.1 ± 6.5 cm in the combination therapy group and 25.5 ± 6.1 cm in the DCB only group (P = 0.703). The 6-month and 12-month primary patency rates were significantly higher in the combination therapy group (94.4% [standard error, 0.038] and 77.8% [0.069], respectively) than in the DCB only group (72.4% [0.083] and 48.3% [0.093]; P = 0.010). The freedom from TLR rate at 12 months was 86.1% (standard error, 0.060) in the combination therapy group and 62.1% (0.096) in the DCB only group (P = 0.016). Three patients (combination therapy, n = 2; DCB only, n = 1) developed distal embolization and were treated successfully by additional 6-F guiding catheter aspiration. No deaths or amputations occurred in either group during 12 months of follow-up. CONCLUSIONS: Rotarex S rotational atherectomy plus thrombectomyin combination with DCB was safe and effective in patients with femoropopliteal total in-stent occlusion during12 months of follow-up.
Assuntos
Angioplastia com Balão/métodos , Aterectomia/instrumentação , Artéria Femoral/cirurgia , Doença Arterial Periférica/cirurgia , Artéria Poplítea/cirurgia , Idoso , Aterectomia/métodos , Terapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva , Estudos Retrospectivos , Grau de Desobstrução VascularRESUMO
There are few studies on excimer laser (308 nm) atherectomy in the treatment of infrapopliteal artery disease. The purpose of this retrospective clinical study was to assess the efficacy and safety of excimer laser atherectomy (ELA) in combination with adjuvant drug-coated balloon angioplasty (DCB) compared to DCB for infrapopliteal arterial revascularization in patients with ischemic diabetic foot. From September 2018 to February 2019, a total of 79 patients with diabetic foot were treated for infrapopliteal arterial revascularization at Tianjin First Central Hospital (Tianjin, China). In this project, 35 patients were treated with ELA combined with DCB angioplasty, and 44 patients were treated with DCB angioplasty. The patients' baseline characteristics were similar between the 2 groups. The primary efficacy endpoints through 24 months were clinically driven target lesion revascularization (CD-TLR), wound healing rate, major amputation rate, and target vessel patency rate. The primary safety endpoint through 24 months was all-cause mortality. The primary efficacy results at 24 months of ELA + DCB versus DCB were CD-TLR of 14.3% versus 34.1% (p = 0.044), wound healing rate of 88.6% versus 65.9% (p = 0.019), target vessel patency rate of 80.0% versus 52.3% (p = 0.010), and major amputations rate of 5.7% versus 22.7% (p = 0.036). The safety signal at 24 months of all-cause mortality rate was 2.9% for ELA + DCB group and 4.5% for DCB group (p = 0.957). ELA combined with DCB angioplasty is more effective than DCB in the treatment of infrapopliteal artery disease in patients with ischemic diabetic foot, which can improve the wound healing rate and target vessel patency rate. There was no statistical difference in the safety results between the two groups.