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1.
JACC Cardiovasc Interv ; 14(3): 333-341, 2021 02 08.
Artigo em Inglês | MEDLINE | ID: mdl-33541543

RESUMO

OBJECTIVES: The authors analyzed data from the NCDR (National Cardiovascular Data Registry) PVI Registry and defined acute kidney injury (AKI) as increased creatinine of ≥0.3 mg/dl or 50%, or a new requirement for dialysis after PVI. BACKGROUND: AKI is an important and potentially modifiable complication of peripheral vascular intervention (PVI). The incidence, predictors, and outcomes of AKI after PVI are incompletely characterized. METHODS: A hierarchical logistic regression risk model using pre-procedural characteristics associated with AKI was developed, followed by bootstrap validation. The model was validated with data submitted after model creation. An integer scoring system was developed to predict AKI after PVI. RESULTS: Among 10,006 procedures, the average age of patients was 69 years, 58% were male, and 52% had diabetes. AKI occurred in 737 (7.4%) and was associated with increased in-hospital mortality (7.1% vs. 0.7%). Reduced glomerular filtration rate, hypertension, diabetes, prior heart failure, critical or acute limb ischemia, and pre-procedural hemoglobin were independently associated with AKI. The model to predict AKI showed good discrimination (optimism corrected c-statistic = 0.68) and calibration (corrected slope = 0.97, intercept of -0.07). The integer point system could be incorporated into a useful clinical tool because it discriminates risk for AKI with scores ≤4 and ≥12 corresponding to the lower and upper 20% of risk, respectively. CONCLUSIONS: AKI is not rare after PVI and is associated with in-hospital mortality. The NCDR PVI AKI risk model, including the integer scoring system, may prospectively estimate AKI risk and aid in deployment of strategies designed to reduce risk of AKI after PVI.

2.
J Invasive Cardiol ; 33(2): E95-E98, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33443489

RESUMO

BACKGROUND: Vessel prepping is an essential component of an optimal strategy in treating infrainguinal peripheral arterial disease. Vessel prepping with atherectomy can be aggressive in certain lesion morphologies, such as severe calcium, total occlusion, or in-stent restenosis, or can target vessel compliance without aggressive debulking. Drug elution is likely to be enhanced by vessel prepping. Optimal vessel prepping requires precise imaging of the vessel size, plaque morphology, and lesion severity/length which cannot be assessed adequately by angiography. Also, intravascular ultrasound provides information post treatment on minimal luminal area gain, residual dissections, geometric miss, and stent apposition and expansion.

3.
J Invasive Cardiol ; 33(1): E16-E18, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33385981

RESUMO

BACKGROUND: The presence of 50% or more stenosis on intravascular ultrasound (IVUS) is considered diagnostic of iliac vein compression (ILVC) by most operators. We have previously developed a scoring system combining minimal luminal area (MLA) at the compression site and age to predict ILVC as seen on IVUS. We present a revised and improved scoring system following an additional number of patients and limited to patients 65 years of age and younger. METHODS: Patients were included from retrospective (n = 52) and prospective (n = 18) registries of consecutive patients who underwent computed tomography angiography (CTA) of the pelvis with venous filling and IVUS within a few weeks apart to evaluate for symptomatic ILVC at a single cardiovascular practice. Quantitative vascular analysis was performed on all images obtained. MLA and age were used to calculate a score derived from a previously published logistic regression formula. Patients >65 years in age were excluded. The predicted findings from the score were compared with the actual presence of compression on IVUS. The revised scoring system is based on a score of < or ≥ 0.533824 and MLA (mm²) of <140, ≥140 to <200, and ≥200. The negative predictive value (NPV) and positive predictive value (NPV and PPV) of each cut-off in predicting ILVC on IVUS were calculated. RESULTS: A total of 70 symptomatic patients were included (mean age, 52.6 ± 12.3 years). The model offered the following: accuracy = 54/70 (77.1%); sensitivity = 51/52 (98.1%); specificity = 3/18 (16.7%); PPV = 51/66 (77.3%); and NPV = 3/4 (75.0%). CONCLUSION: A scoring system using MLA on CTA and age provides a fairly accurate diagnostic test to predict the presence of significant ILVC as seen on IVUS.

4.
J Invasive Cardiol ; 32(10): E250-E253, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32999095

RESUMO

Sizing of iliac vein stents remains controversial. We present the first Venovo venous stent (BD/Bard) that was explanted because of worsening of back and leg pain post treatment and analyze data from the first 50 consecutive Venovo venous stents from our center. Stent size was obtained with intravascular ultrasound of the ipsilateral common iliac vein. The data indicate that there is no statistical relationship between the stent size and worsening or emergence of low back and leg pain. Patient-specific factors may be contributing to this extremely rare and persistent pain beyond the 30-day follow-up.

5.
Int J Angiol ; 29(3): 205-209, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32904731

RESUMO

Critical limb ischemia is associated with high rates of amputation and death. Endovascular revascularization prevents amputation in approximately 80 to 90% of patients. Traditional access, however, can be a problem in some patients and pedal access may be the only way to provide adequate revascularization and potentially prevents an amputation. We present three cases to illustrate how pedal access can be the last frontier to save a leg.

6.
Artigo em Inglês | MEDLINE | ID: mdl-32921595

RESUMO

BACKGROUND: Treatment of common femoral artery (CFA) disease has been traditionally surgical. Recent data indicate that an endovascular option is feasible in treating CFA disease but there remains significant controversy about the endovascular versus surgical approach to treatment. Newer modalities of therapy have emerged to treat the CFA including atherectomy and drug coated balloons. We retrospectively reviewed data on the long-term outcome of endovascular treatment of CFA from 2 medical centers. METHODS: Consecutive patients with CFA disease treated by 6 operators using endovascular techniques from January 1, 2012 to December 31, 2017 were reviewed and analyzed. Two-year follow up was completed using medical records. Demographic, clinical, procedural and angiographic variables were collected. The primary endpoint of the study was target lesion revascularization (TLR). Secondary endpoints included target vessel revascularization (TVR), mortality, unplanned major and minor amputations and 30-day periprocedural adverse events. Descriptive analysis was performed on all variables. Kaplan-Meier for freedom from TLR was plotted. The study was approved by the Ethics Committee at our center. RESULTS: A total of 89 patients (116 limbs) were included at Index. There were males 57.3%, diabetics 42.7%. Mean age was 65.1 ± 16.3 years. Critical limb ischemia (CLI) was present in 27.7%. Disease distribution was classified by the Medina classification: 1-0-0 (CFA only) 48.3%, 1-0-1 (CFA + profunda) 6.9%, 1-1-1 (CFA+ profunda + origin of superficial femoral artery) 16.4%, 1-1-0 (CFA and origin of SFA) 28.4%. Denovo disease was present in 70.7%. Atherectomy was used in 104/116 limbs (89.7%). Drug coated balloons (DCB) in 15.5%, and stenting in 22.4%. Baseline stenosis 81.2 ± 13.1%, lesion length was 42.0 ± 14.5 mm. Final stenosis was 13.3 ± 11.0. Major bleeding occurred in 2.6%. At 2-year mortality was 9.0% (none related to procedure), CLI was 5.9% and no unplanned major or minor amputations. At 2-year KM analysis showed a probability of freedom from TLR of 72.2%. At 2-year the following TLRs were noted for various devices used: PTA 50%, orbital atherectomy 0%, jetstream 29.2%, laser 36.4%, and SilverHawk/TurboHawk 23.1% (p = 0.0476). CONCLUSION: Endovascular treatment of CFA predominantly with atherectomy in this cohort, is feasible and with acceptable outcomes considering a low percentage of DCB use. A randomized trial is needed to validate these findings and explore the added role of DCB and atherectomy on clinical outcomes when compared to endarterectomy.

7.
J Endovasc Ther ; : 1526602820951916, 2020 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-32885736

RESUMO

PURPOSE: To report the results of a study evaluating JetStream atherectomy for the treatment of in-stent restenosis (ISR). MATERIALS AND METHODS: The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective, multicenter study (JET-ISR) of 60 patients (mean age 70.2±10.8 years; 40 men) with femoropopliteal ISR (ClinicalTrials.gov identifier NCT02730234). Lesion length was 19.9±13.5 cm; 33 (55%) were chronic total occlusions and 26 (45%) were TransAtlantic Inter-Society Consensus class D. No drug-bearing device was allowed, and stenting was performed only for bailout. Lesion characteristics and stent integrity were evaluated by an independent core laboratory. The primary endpoint was target lesion revascularization (TLR) at 6 months with bailout stenting considered as TLR. Secondary endpoints included TLR (without bailout stenting) and clinical patency (no restenosis or TLR) at 1 year. The Kaplan-Meier method was employed to evaluate time-to-event endpoints; estimates are given with 95% confidence interval (CI). RESULTS: Bailout stenting was required in 6 of 60 limbs (10%). There were no stent fractures or deformities after atherectomy + adjunctive angioplasty reported by the core laboratory. Kaplan-Meier estimates of freedom from TLR at 6 months and 1 year were 79.3% (95% CI 68.9% to 89.8%) and 60.7% (95% CI 47.8% to 73.6%), respectively. When bailout stenting at the index procedure was not considered a TLR event, freedom from TLR estimates at 6 months and 1 year were 89.3% (95% CI 81.2% to 97.4%) and 66.8% (95% CI 54.3% to 74.2%), respectively. Clinical patency rates at 6 months and 1 year were 77.5% (31/40) and 51.7% (15/29), respectively. CONCLUSION: JetStream atherectomy using the XC device and no drug-eluting devices is feasible, with good clinical patency and 1-year freedom from TLR.

8.
Vasc Health Risk Manag ; 16: 271-284, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32753875

RESUMO

Introduction: Previous studies have suggested that women with chroniclimb-threatening ischemia (CLTI) may have worse outcomes than men. The aim of this study was to determine whether there are sex-related differences in outcomes of patients with CLTI undergoing endovascular treatment with current endovascular technologies. Patients and Methods: Data were derived from the LIBERTY 360 study (NCT01855412). Hazard ratios and the respective 95% confidence intervals were synthesized to examine the association between sex and all-cause mortality, target vessel revascularization (TVR), major amputation, major adverse event (MAE) and major amputation/death up to 3 years of follow-up. Results: A total of 689 patients with CLTI (female: N=252 vs male: N=437) treated with any FDA approved or cleared device were included. The mean lesion length was 126.9±117.3mm and 127.4±113.3mm for the female and male patients, respectively. Although a slightly higher incidence of in-hospital mortality was observed in the female group (1.2% vs 0.0%, p=0.049), there was no difference in female vs male survival rates during follow-up. However, the risk of major amputation at 18 months was higher for the male group (male vs female: HR: 2.36; 95% CI: 1.09-5.12; p=0.030). No difference between the two groups was detected in terms of TVR or MAE during follow-up. Discussion: Data regarding sex-related disparity in outcomes after endovascular therapy of patients with CLTI are conflicting. Gender-related characteristics rather than biological sex characteristics might be the cause of these conflicting findings. Further studies are needed to evaluate the role of sex in revascularization outcomes among this high-risk population.


Assuntos
Angioplastia com Balão , Isquemia/terapia , Doença Arterial Periférica/terapia , Idoso , Idoso de 80 Anos ou mais , Amputação , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/mortalidade , Causas de Morte , Doença Crônica , Feminino , Mortalidade Hospitalar , Humanos , Isquemia/diagnóstico , Isquemia/mortalidade , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/mortalidade , Estudos Prospectivos , Medição de Risco , Fatores de Risco , Fatores Sexuais , Fatores de Tempo , Resultado do Tratamento
9.
J Invasive Cardiol ; 32(8): 289-294, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32737264

RESUMO

BACKGROUND: We present the results of a patient-level meta-analysis of the two currently completed and core-lab adjudicated prospective trials of Jetstream atherectomy system (Boston Scientific) in femoropopliteal in-stent restenosis (FP-ISR) and compare the findings to a published, prespecified 6-month performance goal of target-lesion revascularization (TLR) with angioplasty alone. METHODS: The JETSTREAM-ISR (n = 29 patients; n = 32 lesions) was a two-center feasibility study that evaluated Jetstream atherectomy in FP-ISR. The JET-ISR (n = 60 patients; n = 60 lesions) was a 10-center investigational device exemption study that evaluated the same. Both trials were investigator-initiated, prospective, single-arm designs, with core lab assessments of stent-device interaction and with nearly identical inclusion/exclusion criteria and data definitions. The primary endpoint was TLR, which was analyzed using proportional and Kaplan-Meier analyses. RESULTS: A total of 92 lesions were treated in 89 patients. Kaplan-Meier freedom from TLR at 6 months was 78.5% (95% confidence interval, 69.9-87.1). Proportional TLR was 21.2% (18/85 limbs). The performance goal of TLR (bailout stent included as TLR) was set at 37.9% at 6 months with balloon angioplasty alone. TLR rate derived from the meta-analysis was significantly lower than the TLR rate set for the historic control accounting for the 95% confidence interval lower bound (P<.01). There was no device-stent interaction and no amputation. Distal embolization occurred in 11/92 (12.0%) (filters used in 76.1% of all cases) and bailout stenting was performed in 8.7%. CONCLUSION: In this meta-analysis, Jetstream atherectomy in treating FP-ISR had a high freedom from TLR despite no adjunctive drug-coated balloon use. Randomized trials are needed to confirm these findings.

10.
Am J Cardiol ; 133: 171-174, 2020 10 15.
Artigo em Inglês | MEDLINE | ID: mdl-32838929

RESUMO

BACKGROUND: There has been a continuous debate about the survival benefit of percutaneous coronary intervention (PCI) for the management of patients with stable ischemic heart disease (SIHD) and moderate to severe ischemia. In this study we aimed to summarize the currently available evidence from randomized controlled trials (RCTs) on PCI versus medical therapy (MT) for patients with SIHD. METHODS: An electronic database search was conducted for RCTs that compared PCI on top of MT versus MT alone. A random effects model was used to calculate relative risk (RR) and 95% confidence intervals (CIs). RESULTS: A total of 7 RCTs with 10,043 patients with a mean age of 62.54 ± 1.56 years and a median follow up of 3.9 years were identified. Among patients with SIHD and moderate to severe ischemia by stress testing, PCI didn't show any benefit for the primary outcome of all-cause mortality compared to MT(RR = 0.85; 95% CI 0.646-1.12; p = 0.639). There was also no benefit in cardiovascular (CV) death (RR = 0.88 ; 95% CI 0.71-1.09; p = 0.18) or myocardial infarction (MI) (RR = 0.271; 95% CI 0.782-1.087; P = 0.327) in the PCI group as compared to MT. CONCLUSION: Among patients with SIHD and evidence of moderate to severe ischemia by stress testing, PCI on top of MT appears to add no mortality benefit as compared to with MT alone.


Assuntos
Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/terapia , Infarto do Miocárdio/epidemiologia , Intervenção Coronária Percutânea , Doença da Artéria Coronariana/complicações , Humanos
11.
Artigo em Inglês | MEDLINE | ID: mdl-32563711

RESUMO

BACKGROUND: Calcium is a predictor of poor outcome in the treatment of infrainguinal arterial disease. Rotational atherectomy can effectively debulk atherosclerotic calcium but is less likely to significantly modify medial and adventitial calcinosis. Shockwave IVL provides circumferential sonic pressure waves capable of disrupting deeper calcium and theoretically complements the debulking process of atherectomy. We present acute and intermediate outcome data from patients with severe femoral or iliac artery calcified disease treated with the combination of rotational atherectomy and Shockwave IVL at a single center. METHODS: This is a retrospective study of prospectively collected data on rotational atherectomy (Jetstream (Boston Scientific) and orbital atherectomy (CSI)) from a single operator at a single center with core laboratory analysis of angiographic imaging. All patients that received the combination treatment of rotational atherectomy and Shockwave IVL were included in this study. Patient follow-up was done from medical records with data extracted by an experienced research coordinator. Primary safety endpoint was freedom from major adverse events including major dissection (NHLBI C or higher), perforation, distal embolization, or major amputation defined as amputation above the ankle. Primary effectiveness endpoint was procedural success (≤ 30% residual at end of procedure). 23/24 (95.8%) patients were treated with drug coated balloons (DCB) post combination therapy. Secondary endpoint on follow-up was target lesion revascularization (TLR). RESULTS: A total of 24 patients were included. Mean age was 70.7 ± 9.9 years. Lesions were in the femoropopliteal 79.1%, common femoral 12.5% and iliac 8.3% arteries. 87.0% were claudicants and 58.3% diabetics. Chronic total occlusion was 12.5%, severe calcium 100%, lesion length 84.5 ± 37.1 mm, baseline stenosis 57.1 ± 18.9% and baseline minimal luminal diameter (MLD) 2.2 ± 1.1 mm. Patients were treated with Jetstream (n = 19) or Orbital (n = 5) atherectomy. Embolic filter was used in 58.3% of cases. Post atherectomy stenosis was 36.4 ± 17.5%, post adjunctive IVL 21.1 + 15.7%, and final stenosis 13.0 ± 10.9%. Bailout stenting was 4.6% and primary stenting 13.6% (total stenting rate 18.2%). Final MLD was 4.7 ± 0.8 mm, resulting in an acute gain of 2.5 mm. No infrapopliteal embolization or amputation was noted. At a mean follow up of 591.4 ± 175.2 days, 2 patients died (unrelated to procedure or device). Target lesion revascularization (TLR) at 12 months occurred in 2 patients or 2/22 (9%). At 18-month of follow up TLR occurred in 7/22 (31%) patients. CONCLUSION: The combination of atherectomy and shockwave IVL followed by adjunctive DCB is safe and appears to be effective in treating severe calcified disease with acceptable TLR on long term follow-up in a population of severe femoropopliteal disease.

12.
J Endovasc Ther ; 27(4): 575-580, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32419593

RESUMO

PURPOSE: To investigate if imaging with intravascular ultrasound (IVUS) yields a more accurate estimate of vessel diameter and the presence of dissections than angiography after intervention in the infrapopliteal arteries. MATERIALS AND METHODS: A prospective, single-center study enrolled 20 consecutive patients (mean age 74.1±12.4 years; 12 women) with infrapopliteal disease who were treated with percutaneous transluminal angioplasty (PTA; n=10) or orbital atherectomy (OA) followed by PTA (n=10). The majority of patients were hypertensive and half were diabetic. The overall lesion length was 7.3±6.3 cm, and the diameter stenosis was 80.3%±22.1%. The baseline characteristics did not differ between the groups. Vessel diameters were measured using IVUS from the internal elastic lamina (IEL) to the IEL. IVUS was performed at baseline, post PTA or OA, and post OA+PTA. Quantitative vascular angiography (QVA) and IVUS were analyzed by a core laboratory. Dissections on cine images were categorized based on the National Heart Lung and Blood Institute (NHLBI) classification, while the arc and depth were used to characterize dissections on IVUS images. RESULTS: Mean vessel diameter by QVA was 2.9±0.6 vs 4.0±1.0 mm by IVUS according to the core laboratory (mean difference 1.1±0.9, p<0.001). On angiography, there were 7 dissections after PTA (6 C, 1 D), 1 dissection after OA (1 B), and 2 dissections after OA+PTA (1 A, 1 B; p=0.028 vs post PTA). IVUS uncovered 3.8 times more dissections than seen on angiography. There were 23 dissections after PTA (18 intima, 3 media, 2 adventitia), 12 dissections after OA (8 intima, 1 media, 3 adventitia), and 11 dissections following OA+PTA (7 intima, 1 media, 3 adventitia; p=0.425 vs PTA). Bailout stenting (all due to angiographic dissections ≥C) was necessary in 6 of the PTA cohort and none of the OA+PTA group. CONCLUSION: In addition to underestimating the infrapopliteal vessel diameter by ~25%, angiography underappreciated the presence and severity of post-intervention dissections vs IVUS, particularly in the OA+PTA group.


Assuntos
Angioplastia com Balão/efeitos adversos , Aterectomia/efeitos adversos , Isquemia/terapia , Perna (Membro)/irrigação sanguínea , Doença Arterial Periférica/terapia , Artéria Poplítea/diagnóstico por imagem , Radiografia Intervencionista , Ultrassonografia de Intervenção , Lesões do Sistema Vascular/diagnóstico por imagem , Idoso , Idoso de 80 Anos ou mais , Angioplastia com Balão/instrumentação , Aterectomia/instrumentação , Doença Crônica , Feminino , Humanos , Isquemia/diagnóstico por imagem , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/lesões , Artéria Poplítea/fisiopatologia , Valor Preditivo dos Testes , Estudos Prospectivos , Radiografia Intervencionista/efeitos adversos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Ultrassonografia de Intervenção/efeitos adversos , Grau de Desobstrução Vascular , Lesões do Sistema Vascular/etiologia , Lesões do Sistema Vascular/fisiopatologia
13.
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.

14.
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
15.
Cardiovasc Revasc Med ; 21(1): 86-92, 2020 01.
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.


Assuntos
Aterectomia/instrumentação , Lasers de Estado Sólido/uso terapêutico , Doença Arterial Periférica/terapia , Calcificação Vascular/terapia , Idoso , Idoso de 80 Anos ou mais , Amputação , Aterectomia/efeitos adversos , Aterectomia/mortalidade , Constrição Patológica , Europa (Continente) , Feminino , Humanos , Lasers de Estado Sólido/efeitos adversos , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Intervalo Livre de Progressão , Estudos Prospectivos , Recidiva , Medição de Risco , Fatores de Risco , Fatores de Tempo , Estados Unidos , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/mortalidade , Calcificação Vascular/fisiopatologia , Grau de Desobstrução Vascular
16.
J Endovasc Ther ; 27(1): 60-65, 2020 02.
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.


Assuntos
Ligas , Procedimentos Endovasculares/instrumentação , Artéria Femoral , Doença Arterial Periférica/terapia , Artéria Poplítea , Stents , Idoso , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Pontuação de Propensão , Desenho de Prótese , Sistema de Registros , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular
17.
Cardiovasc Revasc Med ; 21(1): 96-99, 2020 01.
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.


Assuntos
Aterectomia/instrumentação , Dispositivos de Proteção Embólica , Embolia/prevenção & controle , Artéria Femoral , Doença Arterial Periférica/terapia , Artéria Poplítea , Idoso , Aterectomia/efeitos adversos , Embolia/etiologia , 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 , Desenho de Prótese , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
18.
JACC Cardiovasc Interv ; 12(20): 1991-2001, 2019 10 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).


Assuntos
Angiografia Coronária , Doença da Artéria Coronariana/terapia , Estenose Coronária/terapia , Vasos Coronários/diagnóstico por imagem , Reserva Fracionada de Fluxo Miocárdico , Intervenção Coronária Percutânea , Idoso , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/fisiopatologia , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/fisiopatologia , Vasos Coronários/fisiopatologia , Europa (Continente) , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Valor Preditivo dos Testes , Estudos Prospectivos , Stents , Resultado do Tratamento , Estados Unidos
19.
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
20.
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.


Assuntos
Aterectomia/instrumentação , Terapia a Laser/instrumentação , Lasers de Estado Sólido/uso terapêutico , Doença Arterial Periférica/terapia , Idoso , Idoso de 80 Anos ou mais , Aterectomia/efeitos adversos , Europa (Continente) , Feminino , Humanos , Terapia a Laser/efeitos adversos , Lasers de Estado Sólido/efeitos adversos , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Estudos Prospectivos , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Grau de Desobstrução Vascular
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