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1.
J Invasive Cardiol ; 32(3): E76-E77, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32123148

RESUMO

We present the case of a young woman who became pregnant following placement of a Venovo venous stent (BD/Bard) in her left common iliac vein. Our case illustrates the safety of the Venovo stent during pregnancy. This needs further validation with a larger registry.

2.
Vasc Health Risk Manag ; 16: 67-73, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32110032

RESUMO

Endarterectomy of common femoral artery lesions (CFA) carries favorable long-term results and is currently still considered the gold standard for treating these lesions. Although routine stenting has been considered an option for treating the CFA, it has yielded conflicting results and is currently reserved for a bailout of suboptimal endovascular results. Newer therapies with atherectomy or lithoplasty in conjunction with pharmacologic anti-proliferative therapies are promising with less bailout stenting and dissections but randomized trials are needed to confirm their effectiveness and safety.


Assuntos
Endarterectomia , Procedimentos Endovasculares/métodos , Artéria Femoral/cirurgia , Doença Arterial Periférica/terapia , Idoso , Angioplastia/instrumentação , Aterectomia , Endarterectomia/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Masculino , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Stents , Resultado do Tratamento , Grau de Desobstrução Vascular
3.
J Endovasc Ther ; 27(1): 60-65, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31686573

RESUMO

Purpose: To report a propensity score analysis comparing outcomes of the Supera interwoven nitinol stent to bare nitinol stents (BNS) in the femoropopliteal segment. Materials and Methods: A retrospective study was conducted utilizing data extracted from the Excellence in Peripheral Artery Disease (XLPAD) registry (ClinicalTrials.gov identifier NCT01904851) on 871 patients (mean age 65.1 years; 713 men) who underwent femoropopliteal balloon angioplasty with either Supera stent implantation in 118 limbs or other contemporary BNS in 753 limbs between January 2006 and December 2016. All patients in both groups were matched for baseline demographic and clinical characteristics in a 1:1 propensity score matching using the nearest neighbor method to create the 118-patient matched BNS cohort. One-year outcomes included all-cause mortality, target vessel revascularization (TVR), and target limb revascularization (TLR). An additional core laboratory analysis was conducted to measure the deployed length of Supera stents. Results: In unmatched data, the Supera stent group had a numerically lower rate of TVR (7.6% vs 13.4%, p=0.08) and a significantly lower 1-year TLR rate (7.6% vs 16.2%, p=0.02) compared to the BNS group. Both groups had similar 1-year mortality (2.5% vs 2.7%, p=0.9). Kaplan-Meier analysis demonstrated that the Supera group had a significantly lower risk of TVR (p=0.02) and TLR (p=0.002) than the BNS group. After propensity matching, the 1-year TVR estimate was lower for Supera stents (7.6% vs 12.7%, p=0.08) and significantly lower for TLR (7.6% vs 13.6%, p=0.04) than the BNS group. There was no statistically significant association between Supera stent elongation (>10% of the labeled stent length) and 1-year risk of TLR (p=0.6). Conclusion: Supera stent usage in femoropopliteal intervention was associated with reduced risk of 1-year repeat target limb revascularization compared with BNS treatment in both unmatched and matched cohorts.

4.
Cardiovasc Revasc Med ; 21(1): 86-92, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30559030

RESUMO

BACKGROUND: B-Laser™ is a novel atherectomy device that uses a solid-state third harmonic pulsed Nd:YAG laser with an output of 355 nm. Early data showed that the B-Laser™ is safe in treating a broad range of infrainguinal arterial lesions. We present the results of the EX-PAD-03 U.S. pivotal trial of the EXIMO B-Laser™. METHODS: EX-PAD-03 is a prospective, single-arm, multi-center, international, open-label, clinical study. The study enrolled patients in the United States and Europe. The primary efficacy endpoint was the average reduction in residual diameter stenosis of >20% from baseline prior to any adjunctive therapy achieved by the B-Laser™ catheter alone. The primary safety endpoint was freedom from major adverse events (MAEs) defined as: unplanned target limb amputation above the ankle, clinically driven target lesion revascularization (CD-TLR) and cardiovascular related death. RESULTS: A total of 97 subjects (107 lesions) were enrolled. Mean age was 70.5 years and 51% were males. Diabetes mellitus was present in 42.3%. Mean lesion length was 53.96 ±â€¯43.18 mm and 26.2% had severe calcification. Lesions were de novo (79.4%), followed by in-stent restenosis (ISR) (15.9%) and non in-stent restenosis (4.7%). The mean percent stenosis at the target lesion as assessed by the Core lab was 85.7% ±â€¯12.2 (femoro-popliteal 85.6 ±â€¯12.8%; tibials 86.0 ±â€¯9.6%). Post B-Laser™ and prior to adjunctive therapy, the mean percent stenosis at the target lesion was 52.1%. This resulted in a mean reduction from baseline to post B-Laser™ of 33.6% ±â€¯14.2% meeting the primary efficacy endpoint goal. The freedom from MAE through the 30-day follow-up period after intervention was 98.9%. Per Core lab, there was no device-related distal embolization, dissections that required additional therapy, perforation, or pseudoaneurysm. Bailout stenting was 0.9%. A significant improvement from baseline in ABI (0.24 ±â€¯0.18), Rutherford category (-1.79 ±â€¯1.22) and WIQ (0.26 ±â€¯0.28) were noted at 1 month. There was no target lesion revascularization and the patency was 96.8% by duplex ultrasound criteria at 30-day follow up. CONCLUSION: The Eximo B-Laser™ is effective and safe in ablating atherosclerotic and restenotic tissue for both above and below the knee obstructive arterial disease. The device has a high safety profile including a low risk of distal embolization.

5.
Cardiovasc Revasc Med ; 21(1): 96-99, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30503038

RESUMO

BACKGROUND: The WIRION EPS filter was recently approved by the Food and Drug Administration (FDA) to be used in conjunction with all atherectomy devices when treating infrainguinal peripheral arterial disease. The safety of this filter with Jetstream atherectomy (JA) in a real world setting remains unclear. METHODS: Consecutive patients from the practice of one operator who underwent JA under WIRION EPS when treating femoropopliteal arteries were enrolled in this retrospective analysis. The primary safety endpoint was the ability of the filter to capture macrodebris with no dissection or thrombosis at the filter site and no filter-related major adverse events. Descriptive analysis on demographics, clinical, procedural and angiographic variables was done using mean ±â€¯SD for continuous variables and percentages for categorical variables. RESULTS: 37 patients were enrolled in this study between June 2016 and September of 2018 (64.9% males, age 68.7 ±â€¯9.0, BMI 27.7 ±â€¯5.4). TASC II classification of the treated lesions were 51.4% B, 24.3% A, 21.6% C, and 2.7% D. At the filter site, spasm occurred in 1/37 (2.7%), while dissection did not occur (0%). Embolization within the filter was found in 51.4% of patients: 14/37 (37.8%) macro debris and 5/35 (13.5%) micro debris. Clinically significant embolization distal to the filter that required treatment with more than a simple aspiration was 1/37 (2.7%). CONCLUSION: WIRION EPS filter use with Jetstream atherectomy was safe and was associated with a low rate of significant distal embolization that required more than a simple aspiration to treat.

6.
JACC Cardiovasc Interv ; 12(20): 1991-2001, 2019 Oct 28.
Artigo em Inglês | MEDLINE | ID: mdl-31648761

RESUMO

OBJECTIVES: This study sought to evaluate the incidence and causes of an abnormal instantaneous wave-free ratio (iFR) after angiographically successful percutaneous coronary intervention (PCI). BACKGROUND: Impaired coronary physiology as assessed by fractional flow reserve is present in some patients after PCI and is prognostically relevant. METHODS: DEFINE PCI (Physiologic Assessment of Coronary Stenosis Following PCI) was a multicenter, prospective, observational study in which a blinded iFR pull back was performed after angiographically successful PCI in 562 vessels in 500 patients. Inclusion criteria were angina with either multivessel or multilesion coronary artery disease with an abnormal baseline iFR. The primary endpoint of the study was the rate of residual ischemia after operator-assessed angiographically successful PCI, defined as an iFR <0.90. The causes of impaired iFR were categorized as stent related, untreated proximal or distal focal stenosis, or diffuse atherosclerosis. RESULTS: An average of 1.1 vessels per patient had abnormal baseline iFRs, with a mean value of 0.69 ± 0.22, which improved to 0.93 ± 0.07 post-PCI. Residual ischemia after angiographically successful PCI was present in 112 patients (24.0%), with a mean iFR in that population of 0.84 ± 0.06 (range 0.60 to 0.89). Among patients with impaired post-PCI iFRs, 81.6% had untreated focal stenoses that were angiographically inapparent, and 18.4% had diffuse disease. Among the focal lesions, 38.4% were located within the stent segment, while 31.5% were proximal and 30.1% were distal to the stent. Post-PCI vessel angiographic diameter stenosis was not a predictor of impaired post-procedural iFR. CONCLUSIONS: Blinded post-PCI physiological assessment detected residual ischemia in nearly 1 in 4 patients after coronary stenting despite an operator-determined angiographically successful result. Most cases of residual ischemia were due to inapparent focal lesions potentially amenable to treatment with additional PCI. (Physiologic Assessment of Coronary Stenosis Following PCI [DEFINE PCI]; NCT03084367).

7.
Vasc Health Risk Manag ; 15: 283-290, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31496717

RESUMO

Angiography remains a widely utilized imaging modality during vascular procedures. Angiography, however, has its limitations by underestimating the true vessel size, plaque morphology, presence of calcium and thrombus, plaque vulnerability, true lesion length, stent expansion and apposition, residual narrowing post intervention and the presence or absence of dissections. Intravascular ultrasound (IVUS) has emerged as an important adjunctive modality to angiography. IVUS offers precise imaging of the vessel size, plaque morphology and the presence of dissections and guides interventional procedures including stent sizing, assessing residual narrowing and stent apposition and expansion. IVUS-guided treatment has shown to yield superior outcomes when compared to angiography-only guided therapy. The cost-effectiveness of the routine use of IVUS during vascular procedures needs to be further studied.


Assuntos
Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Ultrassonografia de Intervenção , Doença da Artéria Coronariana/fisiopatologia , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Humanos , Doença Arterial Periférica/fisiopatologia , Valor Preditivo dos Testes , Fatores de Risco , Índice de Gravidade de Doença , Stents , Resultado do Tratamento
8.
Am Heart J ; 216: 74-81, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31419621

RESUMO

Lower extremity peripheral artery disease (PAD) and cerebrovascular disease (CeVD) are prevalent conditions in the United States, and both are associated with significant morbidity (eg, stroke, myocardial infarction, and limb loss) and increased mortality. With a growth in invasive procedures for PAD and CeVD, this demands a more clear responsibility and introduces an opportunity to study how patients are treated and evaluate associated outcomes. The American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) Peripheral Vascular Intervention (PVI) Registry is a prospective, independent collection of data elements from individual patients at participating centers, and it is a natural extension of the already robust NCDR infrastructure. As of September 20, 2018, data have been collected on 45,316 lower extremity PVIs, 12,417 carotid artery stenting procedures, and 11,027 carotid endarterectomy procedures at 208 centers in the United States. The purpose of the present report is to describe the patient and procedural characteristics of the overall cohort and the methods used to design and implement the registry. In collecting these data, ACC and ACC PVI Registry have the opportunity to play a pivotal role in scientific evidence generation, medical device surveillance, and creation of best practices for PVI and carotid artery revascularization.

9.
Catheter Cardiovasc Interv ; 94(7): 1010-1017, 2019 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-31408257

RESUMO

BACKGROUND: The B-Laser™ atherectomy system (Eximo Medical, Israel) is a 355 nm solid-state Nd:YAG short pulse laser for de-novo and restenotic infrainguinal PAD with enhanced affinity for atheroma and calcified plaque. METHODS: The study was a prospective, single-arm, multi-center, international, open-label study assessing the B-Laser™ in symptomatic (Rutherford 2 to 4) infrainguinal peripheral artery disease. Primary core lab efficacy was mean reduction in diameter stenosis >20% by the B-Laser™ catheter alone. Cardiovascular death, major amputation, target lesion revascularization, WIQ, ABI and Rutherford class were obtained at baseline and out to 6 months. Duplex ultrasound patency (PSVR <2.5), was evaluated by Core Lab. RESULTS: 97 (77 in USA) PAD subjects (51 male, mean 70.5 years [range 46-86]) with 107 lesions were treated with B-Laser™ (average length 5.4 cm [range 1-24], 29.0% infrapopliteal. 77.6% calcification [26.2% severe], 21.5% chronic total occlusions, 20.6% re-stenotic). Average reduction in residual stenosis post B-Laser™ alone was 33.6 ± 14.2%. Baseline and final stenosis (post laser and adjunctive therapy) were 85.7 ± 12.2% and 17.7 ± 11.0%, respectively. Duplex patency was 96.8% at 30-days and 85.6% at 6 months (95.7% 6-month patency with severe calcification), and did not differ between POBA vs. DCB sub-groups. ABI, Rutherford category and WIQ all improved. There was one MAE and three TLRs out of 101 lesions. No procedural distal embolization was noted and there were no major device-related dissections. CONCLUSIONS: Experience with the B-Laser™ atherectomy system in infrainguinal PAD procedures demonstrates a high level of safety and efficacy for denovo and restenotic infrainguinal arterial lesions.

11.
Vasc Health Risk Manag ; 15: 115-122, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31190849

RESUMO

Iliac vein compression (LIVC) is a prevalent finding in the general population, but a smaller number of patients are symptomatic. ILVC should be considered in symptomatic patients with unexplained unilateral lower leg swelling. Patients typically complain of one or more of the following symptoms: lower leg pain, heaviness, venous claudication, swelling, hyperpigmentation and ulceration. ILVC can be thrombotic, combined with acute or chronic DVT, or non-thrombotic. ILVC is best diagnosed with intravascular ultrasound (IVUS), but computed tomography angiography (CTA) and magnetic resonance angiography (MRA) have emerged as valid screening tests. Venography underestimates the severity of ILVC but may provide insights into the anatomy and the presence of collaterals. Based on current available evidence, endovascular therapy with stenting remains the main treatment strategy for ILVC. Dedicated nitinol venous stents are currently under review by the Food and Drug Administration for potential approval in the United States. These stents have been released outside the US. There is no consensus to the optimal anticoagulation regimen post-ILVC stenting. Oral anticoagulants, however, remain a preferred therapy in patients with history of thrombotic ILVC.


Assuntos
Anticoagulantes/administração & dosagem , Diagnóstico por Imagem/métodos , Procedimentos Endovasculares , Veia Ilíaca , Síndrome de May-Thurner , Administração Oral , Anticoagulantes/efeitos adversos , Angiografia por Tomografia Computadorizada , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Humanos , Veia Ilíaca/diagnóstico por imagem , Veia Ilíaca/fisiopatologia , Veia Ilíaca/cirurgia , Angiografia por Ressonância Magnética , Síndrome de May-Thurner/diagnóstico por imagem , Síndrome de May-Thurner/epidemiologia , Síndrome de May-Thurner/fisiopatologia , Síndrome de May-Thurner/terapia , Flebografia/métodos , Valor Preditivo dos Testes , Prevalência , Stents , Resultado do Tratamento , Ultrassonografia Doppler em Cores , Ultrassonografia de Intervenção
12.
J Invasive Cardiol ; 31(5): 121-126, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31034434

RESUMO

BACKGROUND: Luminal gain post balloon angioplasty (PTA) is in part due to the occurrence of dissections. The depth and extent of dissections, however, can influence the short- and long-term outcomes of a procedure. Focal force and scoring balloons have been used to reduce angiographic dissections post PTA. The role of the Flex Vessel Prep (VP) system (VentureMed Group), a dynamic, microincision, non-balloon based system, prior to PTA in reducing and/or limiting severe dissections has not been fully characterized. METHODS: In this prospective pilot study, a total of 15 patients were evaluated by angiography and intravascular ultrasound (IVUS) following treatment of femoropopliteal de novo or no-stent restenosis with the Flex VP system and PTA. Eagle Eye Platinum ST IVUS catheters were used in this study. No atherectomy devices were allowed. Cine and IVUS images were obtained at baseline, after Flex, and following adjunctive PTA. Angiographic and IVUS core labs analyzed the images. RESULTS: Mean patient age was 74.6 ± 11.7 years. Diabetes and claudication were present in 40% and 73.3%, respectively. Median baseline, post-Flex, and postadjunctive PTA stenosis severities were 77.0%, 60.0%, and 34.0%, respectively (P=.07 and P<.001 for baseline vs post Flex and post Flex vs post PTA, respectively). Lesion length was 63.6 ± 32.5 mm. Using PACSS classification for calcium grading, grades 3 and 4 were 6.7% and 40.0%, respectively. Total dissections identified on IVUS post-Flex microincisions were 14 compared with 3 dissections on angiogram (P=.35) (ratio, 4.7 to 1). Post adjunctive angioplasty, there were 49 dissections on IVUS vs 6 on angiogram (P<.01) (ratio, 8.2 to 1). Of these dissections and when compared with baseline, 3 and 37 dissections were new on IVUS post Flex and PTA, respectively. Of these dissections, 2/3 and 7/37 were ≥180° in circumference post Flex and post PTA, respectively. Also, 1/3 and 8/37 dissections involved the media and/or adventitia as seen on IVUS post Flex and PTA, respectively. The majority of dissections post PTA following Flex VP involved mostly the intima (71.4%) and were <180° in circumference (77.6%). CONCLUSION: Dissections are grossly under-appreciated on angiogram when compared with IVUS. Dissections on IVUS post PTA following the Flex VP system involved mostly the intima, with <180° in width. The clinical significance of these findings needs to be further explored.


Assuntos
Angioplastia com Balão/efeitos adversos , Constrição Patológica , Artéria Femoral , Doença Arterial Periférica , Artéria Poplítea , Complicações Pós-Operatórias , Idoso , Idoso de 80 Anos ou mais , Angiografia/métodos , Angioplastia com Balão/métodos , Constrição Patológica/diagnóstico por imagem , Constrição Patológica/etiologia , Constrição Patológica/patologia , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/cirurgia , Humanos , Masculino , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/cirurgia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/cirurgia , Complicações Pós-Operatórias/diagnóstico por imagem , Complicações Pós-Operatórias/patologia , Estudos Prospectivos , Ultrassonografia de Intervenção/métodos
13.
Open J Cardiovasc Surg ; 11: 1179065219834523, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30886524

RESUMO

We present a case of a flush chronic total occlusion of the superficial femoral artery treated successfully with a combined antegrade approach using radial access and a retrograde approach using a pedal access. Patient has total occlusion of the contralateral left external iliac and common femoral artery. Our case illustrates the feasibility of the combined pedal-radial approach in treating flush occlusions of the superficial femoral artery.

14.
J Invasive Cardiol ; 31(1): 1-9, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30611122

RESUMO

BACKGROUND: The contemporary limb outcomes and costs of stent-based vs non-stent based strategies in endovascular revascularization of femoropopliteal (FP) peripheral artery disease (PAD) are not well understood. METHODS AND RESULTS: We present data from the ongoing United States multicenter Excellence in Peripheral Artery Disease Registry between 2006-2016 to compare stent vs non-stent treatment outcomes and associated costs in FP interventions. A total of 2910 FP interventions were performed in 2162 patients (mean age, 66 years), comprising 1339 stent based (superficial femoral artery, 93%) in 1007 patients and 1571 non-stent interventions (superficial femoral artery, 85%) in 1155 patients. A growing trend for non-stent based interventions and a declining trend in repeat revascularization rate at 1 year were observed across years of registry enrollment. Stent implantation was the prevailing strategy in treating longer FP lesions (mean length, 152 mm vs 105 mm; P<.001) and chronic total occlusions (65% vs 40%; P<.001), while stent implantation was employed less frequently when treating in-stent restenotic lesions (14% vs 20%; P<.001). Stent and non-stent interventions had similar 1-year limb outcomes in all-cause death, target-limb revascularization, target-vessel revascularization, and major or minor amputation. The average procedure costs for the stent group were significantly higher than the non-stent group ($6215 vs $4790; P<.001). CONCLUSION: There is a growing trend for non-stent FP artery interventions, with a significant decline in 1-year target-limb revascularization rates over time. One-year limb outcomes in stent-based compared to non-stent interventions are similar; however, at a significantly higher procedural cost.


Assuntos
Análise Custo-Benefício , Procedimentos Endovasculares/métodos , Doença Arterial Periférica/terapia , Sistema de Registros , Stents/economia , Idoso , Angiografia/métodos , Procedimentos Endovasculares/economia , Procedimentos Endovasculares/instrumentação , Feminino , Artéria Femoral/patologia , Artéria Femoral/cirurgia , Custos de Cuidados de Saúde , Humanos , Canal Inguinal , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Artéria Poplítea/patologia , Artéria Poplítea/cirurgia , Prognóstico , Estudos Retrospectivos , Medição de Risco , Stents/estatística & dados numéricos , Resultado do Tratamento , Estados Unidos , Grau de Desobstrução Vascular/fisiologia
15.
Catheter Cardiovasc Interv ; 93(3): 488-493, 2019 02 15.
Artigo em Inglês | MEDLINE | ID: mdl-30499198

RESUMO

BACKGROUND: Use of atherectomy for the treatment of peripheral arterial disease (PAD) is increasing as an adjunctive treatment to either conventional or drug-coated balloon angioplasty. There is limited data on atherectomy outcomes in below-the-knee (BTK) endovascular interventions. METHODS: Data from the multicenter Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851) were analyzed to examine predictors of atherectomy use and its associated 1-year patency rate. We analyzed 518 BTK procedures performed between January 2005 and December 2016. RESULTS: Overall a total of 518 BTK procedures were treated in 430 patients, and 43% of interventions used atherectomy. African American patients were less likely (13% vs 25%; |standard residual| = 3.41) to be treated with atherectomy. Use of atherectomy was lower in chronic total occlusive (CTO) lesions (48% vs 58%; P = 0.02). There were no significant associations of baseline comorbidities, critical limb ischemia (CLI), ankle-brachial index, number of BTK vessel run-off, or vessel location with atherectomy use. Compared with patients without atherectomy, use of atherectomy was associated with lower incidence of repeat target limb intervention at 1 year after adjusting for age, CLI, in-stent restenosis, heavy calcification, presence of diffuse disease, and CTO lesion traits (Hazard Ratio 0.41, 95% confidence interval 0.23-0.72; P < 0.01). CONCLUSIONS: Compared with no atherectomy, use of atherectomy in BTK interventions is associated with lower rates of 1-year repeat target limb revascularization. These findings require confirmation in prospective, randomized clinical studies.

16.
J Invasive Cardiol ; 30(12): 452-455, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30504513

RESUMO

BACKGROUND: Intravascular ultrasound (IVUS) is considered the gold standard in diagnosing common iliac vein (CIV) compression. The presence of >50% surface area reduction by IVUS is considered significant compression by most operators. Thus, we evaluated the role of computed tomography angiography (CTA) and venography in diagnosing CIV compression when compared to IVUS. METHODS: All patients who underwent CTA of the pelvis with venous filling phase, IVUS, and venography within a few weeks apart to evaluate for symptomatic CIV compression from one cardiovascular practice were retrospectively reviewed. Quantitative vascular analysis was performed on all images obtained to determine (1) percent stenosis (PS) by venogram; and (2) minimal lumen area (MLA) and PS by CTA and IVUS at the compression site (using ipsilateral distal CIV as reference area). Spearman's rank correlation, paired t-tests, or signed rank tests were performed as appropriate to compare between values of MLA and PS among the three different imaging modalities. RESULTS: A total of 96 patients were included (62.5% females; mean age, 62.3 ± 14.8 years). A significant correlation was found between MLA-CTA and MLA-IVUS (Spearman's rho, 0.27; P=.01) and PS-CTA and PS-IVUS (Spearman's rho, 0.327; P<.01). A significant correlation was also found between PS-venogram and PS-IVUS (Spearman's rho, 0.471; P<.001). MLA-CTA and MLA-IVUS had a median difference of +41 mm² (95% CI, 25.0-57.5; P<.001) whereas PS-CTA and PS-IVUS were not statistically different (median difference, -5.6 mm²; 95% CI, -12.2 to 0.7). Furthermore, PS-IVUS and PS-venogram had a median difference of +15.2% (95% CI, 10.4-20.1; P<.001). CONCLUSION: PS-venogram correlates with PS-IVUS, but venogram underestimates the PS by an average of 15.2%. In contrast, PS-CTA and PS-IVUS are not statistically different despite an over-estimation of MLA by CTA when compared to IVUS. Therefore, we conclude that PS-CTA and not PS-venogram can be used to predict PS on IVUS.


Assuntos
Angiografia por Tomografia Computadorizada/métodos , Veia Ilíaca/diagnóstico por imagem , Doenças Vasculares Periféricas/diagnóstico , Flebografia/métodos , Ultrassonografia de Intervenção/métodos , Constrição Patológica/diagnóstico , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Estudos Retrospectivos , Fatores de Tempo
17.
Cardiovasc Revasc Med ; 19(7 Pt A): 771-777, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30420096

RESUMO

BACKGROUND: The long-term outcome of Jetstream atherectomy (JA) with or without adjunctive drug coated balloons (DCB) in a real-world setting remains unknown. We report 16-month target lesion revascularization (TLR) rates on patients treated for femoropopliteal (FP) artery disease with JA in a single center by one operator. METHODS: From 1/1/12 to 8/24/16 a total of 311 procedures were performed with atherectomy by a single operator at a single center. Of these procedures, 75 met inclusion and exclusion criteria. This report evaluates the outcomes of these 75 patients treated at index and who were followed up to 16 months. The primary endpoint of the study was clinically driven TLR. Patients were stratified by the use of DCB (vs angioplasty (PTA)) post-JA. TLR was calculated by excluding bailout stenting as TLR. Survival analysis for TLR over time was plotted. RESULTS: 75 patients (49.3% male, mean age 68.0 years, 54.7% diabetes) with de novo or restenotic FP lesions whose symptoms were classified as Rutherford category I-V were enrolled. Adjunctive PTA was performed on 50 patients (26 de novo, 13 in-stent restenosis, 3 non-stent restenosis, 8 mixed lesions) and adjunctive DCB (LUTONIX® 24, IN.PACT® 1) on 25 patients (21 de novo, 1 in-stent restenosis, 2 non-stent restenosis, 1 mixed lesion) (p = 0.0249). There was no difference in the median treated length between the adjunctive PTA (15 cm) and DCB (10 cm) groups (p = 0.0530). The estimated freedom from TLR (fTLR) was significantly higher with atherectomy and adjunctive DCB compared to atherectomy with adjunctive PTA at 12 months (94.7% vs 68.0%, p = 0.002) and 16 months (94.4% vs 54%; p = 0.002). CONCLUSIONS: In a single center cohort of JA reflecting real-world practice, JA with DCB had a superior TLR rate up to 16-month follow-up when compared to JA with PTA in treating all comers FP arterial disease.


Assuntos
Angioplastia com Balão/instrumentação , Aterectomia/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Artéria Femoral , Doença Arterial Periférica/terapia , Artéria Poplítea , Dispositivos de Acesso Vascular , Idoso , Idoso de 80 Anos ou mais , Angioplastia com Balão/efeitos adversos , Aterectomia/efeitos adversos , Fármacos Cardiovasculares/efeitos adversos , Constrição Patológica , Desenho de Equipamento , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Iowa , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Recidiva , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular
18.
JACC Cardiovasc Interv ; 11(19): 1995-2003, 2018 10 08.
Artigo em Inglês | MEDLINE | ID: mdl-30286857

RESUMO

OBJECTIVES: The WISE LE (WIRION™ EPS in Lower Extremities Arteries) study was designed to assess the clinical performance of the WIRION Embolic Protection System (EPS) in subjects undergoing lower extremity atherectomy for the treatment of peripheral artery disease. BACKGROUND: Embolization is ubiquitous during endovascular procedures for lower extremity peripheral artery disease. METHODS: The WISE LE was a multicenter study, performed in the United States and Germany. The primary endpoint was freedom from major adverse events (MAEs) occurring within 30 days post-procedure and was compared with an objective performance goal derived from historical atherectomy trials. MAE was defined as a serious adverse event that resulted in death, acute myocardial infarction, thrombosis, pseudoaneurysm, dissection (grade C or greater), or clinical perforation at the filter location, clinically relevant distal embolism, unplanned amputation, or clinically driven target vessel revascularization. The study also included a histopathological analysis of debris captured by the filter during the procedures. RESULTS: The study protocol specified enrollment of 153 patients with the primary endpoint successfully met if 18 (12.0%) or fewer MAEs occurred. A pre-specified interim analysis performed after 103 patients revealed only 2 MAEs, and the study was stopped because it had met its pre-determined metric for success. Lesion deemed not accessible by the WIRION EPS occurred in 7 patients. Debris of <1-mm, 1- to 2-mm, and >2-mm diameter were found in 98%, 22%, and 9% of patients, respectively. CONCLUSIONS: The WIRION EPS is safe and noninferior to the pre-specified performance goal in capturing debris in the vast majority of patients and with the use of a broad range of atherectomy systems.


Assuntos
Aterectomia/instrumentação , Dispositivos de Proteção Embólica , Embolia/prevenção & controle , Extremidade Inferior/irrigação sanguínea , Doença Arterial Periférica/terapia , Idoso , Aterectomia/efeitos adversos , Embolia/etiologia , Feminino , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/complicações , Estudos Prospectivos , Desenho de Prótese , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
19.
J Invasive Cardiol ; 30(11): 401-405, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30318483

RESUMO

BACKGROUND: We report on intraprocedural and up to 1-year outcomes on the safety of the Atlas Gold balloon (Bard) in iliofemoral venous interventions. METHODS: All patients who underwent iliofemoral vein compression treatment in our laboratory from September 1, 2013 to May 30, 2017 were identified and medical records were reviewed. The primary safety endpoint was the intraprocedural freedom from major device-related serious adverse events (≥95%) for the Atlas Gold balloon in iliofemoral venous treatment. RESULTS: Seventy-seven patients with iliac vein compression underwent intervention. Predilation was performed in 20 patients with the Atlas Gold balloon (mean diameter, 12.1 mm). The mean pressure was 5.2 atm (range, 3.0-14.0 atm). Post-stent dilation was performed in 61 patients treated with the Atlas Gold balloon (mean diameter: 17.0 mm; range: 12 to 22 mm), with a mean pressure of 6.8 atm (range, 2.0-20.0 atm). There was no stent thrombosis, target-lesion revascularization (TLR), or target-vessel revascularization (TVR) at 1 month. Symptom improvement was reported in 89% of patients. There were 58 patients assessed for patency in the total cohort at 262.7 days, of which 48 patients were postdilated with the Atlas Gold balloon. All stents were patent at 1 year, and there was no stent thrombosis, TLR, or TVR in the cohort treated with the Atlas Gold balloon. Symptom improvement continued at 1 year (37/45 Atlas Gold cohort). CONCLUSION: All patients postdilated with the Atlas Gold balloon exceeded the 95% safety benchmark set in this study. No balloon perforation, vessel laceration, or balloon-related intravascular events occurred.


Assuntos
Angioplastia com Balão/instrumentação , Cateterismo Periférico/instrumentação , Procedimentos Endovasculares/métodos , Veia Femoral/cirurgia , Veia Ilíaca/cirurgia , Síndrome Pós-Trombótica/cirurgia , Desenho de Equipamento , Feminino , Veia Femoral/diagnóstico por imagem , Seguimentos , Humanos , Veia Ilíaca/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Flebografia , Síndrome Pós-Trombótica/etiologia , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento , Trombose Venosa/complicações
20.
J Invasive Cardiol ; 30(10): 373-379, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30279293

RESUMO

OBJECTIVES: Paclitaxel drug-eluting stents (DESs) have been shown to improve primary patency of femoropopliteal lesions compared to plain balloon angioplasty with provisional bare-metal stents (BMSs) in randomized controlled studies. However, data are lacking on patency outcomes of real-world DES use relative to BMS use. This study compared clinically driven target-lesion revascularization (TLR), target-vessel revascularization (TVR), and target-limb revascularization outcomes at 1 year between DES and BMS treatments in a real-world setting. METHODS: The study identified 174 DES (Zilver PTX; Cook Medical) and 784 BMS femoropopliteal interventions from the available 969 Excellence in Peripheral Artery Disease (XLPAD) registry patients between October 2013 and December 2016. We analyzed both unmatched (174 DES and 784 BMS) and propensity score (PS)-matched datasets (174 for each). RESULTS: This study found that patients who underwent DES femoropopliteal endovascular revascularization had significantly lower TLR rates in both unmatched (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.35-0.91; P=.02) and matched data (HR, 0.50 95% CI, 0.27-0.91; P=.02). The DES group had a 43% lower TVR risk than the BMS group in the PS matched cohort (HR, 0.57; 95% CI, 0.33-0.98; P=.04). Mortality rate in the DES group (5%) was significantly higher than the BMS group in both unmatched (2%; P=.04) and matched groups (1%; P=.046) at 1 year. CONCLUSIONS: Patients treated with DES had higher lesion and vessel patency than BMS after adjusting for confounding, which included complexity of lesion characteristics and operators' clinical decision-making regarding selection of treatment modalities, in femoropopliteal endovascular interventions in a real-world registry.


Assuntos
Arteriopatias Oclusivas/cirurgia , Stents Farmacológicos , Procedimentos Endovasculares/métodos , Artéria Femoral/cirurgia , Artéria Poplítea/cirurgia , Implantação de Prótese/métodos , Angiografia , Arteriopatias Oclusivas/diagnóstico , Feminino , Artéria Femoral/diagnóstico por imagem , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Artéria Poplítea/diagnóstico por imagem , Desenho de Prótese , Estudos Retrospectivos , Resultado do Tratamento
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