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1.
J Vasc Interv Radiol ; 35(3): 335-348, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38206255

RESUMO

Percutaneous revascularization is the primary strategy for treating lower extremity venous and arterial disease. Angiography is limited by its ability to accurately size vessels, precisely determine the degree of stenosis and length of lesions, characterize lesion morphology, or correctly diagnose postintervention complications. These limitations are overcome with use of intravascular ultrasound (IVUS). IVUS has demonstrated the ability to improve outcomes following percutaneous coronary intervention, and there is increasing evidence to support its benefits in the setting of peripheral vascular intervention. At this stage in its evolution, there remains a need to standardize the use and approach to peripheral vascular IVUS imaging. This manuscript represents considerations and consensus perspectives that emerged from a roundtable discussion including 15 physicians with expertise in interventional cardiology, interventional radiology, and vascular surgery, representing 6 cardiovascular specialty societies, held on February 3, 2023. The roundtable's aims were to assess the current state of lower extremity revascularization, identify knowledge gaps and need for evidence, and determine how IVUS can improve care and outcomes for patients with peripheral arterial and deep venous pathology.


Assuntos
Prova Pericial , Doenças Vasculares , Humanos , Máquina de Vetores de Suporte , Ultrassonografia , Doenças Vasculares/terapia , Ultrassonografia de Intervenção/métodos , Angiografia Coronária
2.
Catheter Cardiovasc Interv ; 100(6): 950-954, 2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-36183400

RESUMO

OBJECTIVES: Here we investigate the safety and efficacy of a continuous mechanical aspiration system when used before percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS). BACKGROUND: Historically, trials of routine manual aspiration thrombectomy in ACS patients have reported mixed results. This may be due to the technical limitations of manual aspiration, which suffers from decreasing vacuum power as aspiration is performed. METHODS: This is a retrospective case series of all patients treated with continuous mechanical aspiration (Indigo CAT RX Aspiration System; Penumbra Inc.) before PCI between August 2017 and July 2020 at five centers in the United States. Data regarding angiographic assessments, procedure, and safety were examined. RESULTS: Seventy-two patients (mean age 60 ± 12.5 years, 34.7% female) with ST Elevation Myocardial Infarction (STEMI) (80.6%) or Non-ST Elevation Myocardial Infarction (NSTEMI) (19.4%) were included. Target vessels were the right coronary (43.1%), left anterior descending (33.3%), and left circumflex (23.6%). Preprocedure, 94.4% had a high thrombus burden (thrombolysis in myocardial infarction [TIMI] thrombus grade ≥ 3). Median aspiration time was 35 s and median access-to-reperfusion time was 10 min. After CAT RX alone, 86.1% had complete perfusion (TIMI flow grade 3). After the procedure, 94.4% had TIMI thrombus grade <3% and 97.2% had TIMI flow grade 3. There were no cases of ischemic stroke. Cardiovascular mortality at 30 days was 1.4%. CONCLUSIONS: In our initial experience, aspirating thrombus from ACS patients using the Indigo CAT RX Aspiration System before PCI was safe and effective for reducing thrombus burden and restoring flow.


Assuntos
Trombose Coronária , Infarto do Miocárdio , Intervenção Coronária Percutânea , Trombose , Feminino , Masculino , Humanos , Sucção , Estudos Retrospectivos , Índigo Carmim , Resultado do Tratamento , Trombectomia/efeitos adversos , Trombectomia/métodos , Trombose/etiologia , Infarto do Miocárdio/etiologia , Trombose Coronária/diagnóstico por imagem , Trombose Coronária/etiologia , Trombose Coronária/terapia , Angiografia Coronária
3.
J Endovasc Ther ; : 15266028221131459, 2022 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-36320143

RESUMO

BACKGROUND: Current endovascular treatments of below the knee (BTK) popliteal or tibial/peroneal arteries including investigational drug-coated balloons have limited long-term efficacy. OBJECTIVES: This Phase 2 trial assessed the feasibility of adventitial deposition of temsirolimus to reduce neointimal hyperplasia and clinically relevant target lesion failure (CR-TLF) 6 months after BTK arterial revascularization. METHODS: This prospective, multicenter, double-blinded, comparative, dose-escalation trial enrolled 61 patients with Rutherford 3 to 5 symptoms undergoing endovascular revascularization of ≥1 angiographically significant BTK lesions. Perivascular infusion after completion of arterial revascularization was randomized into control (saline) vs low-dose (0.1 mg/mL) temsirolimus groups for the first 30 patients. In the second part of the trial, patients were randomized to control versus high-dose (0.4 mg/mL) temsirolimus groups. Primary and secondary efficacy endpoints were target lesion (TL) transverse-view vessel area loss percentage (TVAL%) and CR-TLF at 6 months, respectively. CR-TLF was defined as a composite of ischemia-driven major amputation of the target limb, clinically driven target lesion revascularization (CD-TLR), and clinically relevant TL occlusion. The primary safety endpoint was freedom from major adverse limb events or perioperative death (MALE+POD) at 30 days. RESULTS: There was no discernable difference in effect between temsirolimus doses; therefore, the low- and high-dose cohorts were pooled for the analyses. The principal analysis on the per protocol (PP) group of 53 patients revealed superior primary efficacy of the treatment arm, with reduction in TVAL% of 13.9% absolute (37.3% relative) and the rate of CR-TLF reduced by 27.1% absolute (51.3% relative), at 6 months. Subgroup analysis of all Trans-Atlantic Inter-Society Consensus (TASC) B to D lesions (N=36) revealed TVAL% reduction of 22.3% absolute (48.3% relative) and the rate of CR-TLF reduced by 39.2% absolute (56.6% relative). Freedom from 30-day MALE+POD was 100% in all groups. CONCLUSIONS: This hypothesis-generating trial suggests that adventitial infusion of temsirolimus in BTK arteries improves TVAL% and CR-TLF with no adverse safety signals through 6 months, supporting the move to a Phase 3 trial. CLINICAL IMPACT: There remain gaps in the endovascular treatment of patients with atherosclerotic lesions of below-the-knee (BTK) arteries. The TANGO trial evaluated the use of sub-adventitial temsirolimus with the Bullfrog micro-infusion device during BTK interventions. The therapy was safe and effective. Compared with controls, vessel lumen area patency was improved, and target lesion failure was less frequent. The effects were most appreciable in subjects with higher baseline TASC lesions (B, C, or D). Sub-adventitial temsirolimus offers the potential to improve the results of BTK interventions in this challenging patient population.

4.
Vascular ; 30(1): 72-80, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33730954

RESUMO

BACKGROUND: Carbon dioxide angiography with addition of optical coherence tomography imaging may improve procedural success and clinical outcomes in patients with peripheral artery disease and chronic kidney disease. METHODS: Single-center, retrospective analysis of patients with chronic kidney disease who underwent carbon dioxide angiography and optical coherence tomography-guided chronic total occlusion crossing and/or optical coherence tomography-guided directional atherectomy was performed. Patient and procedure-related characteristics, along with peri- and one-year post-procedural major adverse events, were analyzed. RESULTS: A total of 18 vessels in 11 patients, with mean age 70 years were treated. All had co-morbidities such as hypertension, hyperlipidemia, had history or were current smokers with baseline peripheral artery disease. Majority were diabetic with coronary disease (82%); 55% baseline chronic kidney disease IV, 55% Rutherford class III and 45% class IV. Contrast was used in only two patients. Mean total fluoroscopy time and radiation dose was 24.1 min and 249.2 mGY, respectively. Half of the lesions were femoro-popliteal chronic total occlusions, and Ocelot catheter was used to cross seven of nine chronic total occlusions and was successful in six. Adjunctive optical coherence tomography-guided directional atherectomy was performed in 8 of 11 patients. Only two adverse events occurred: one clinically significant event of slow-flow intra-procedurally and one target limb revascularization within one year of index procedure in a vessel different than prior treated. Optical coherence tomography imaging in both chronic total occlusion-crossing and atherectomy resulted in 10-min mean fluoroscopy reduction time and 32 mGY reduction in radiation dose. CONCLUSION: Carbon dioxide angiography with the addition of optical coherence tomography imaging for chronic total occlusion crossing and/or optical coherence tomography-guided directional atherectomy reduced the need for contrast agents, total fluoroscopy time, and radiation exposure in patients with peripheral artery disease and baseline chronic kidney disease.


Assuntos
Doença Arterial Periférica , Insuficiência Renal Crônica , Idoso , Angiografia , Aterectomia/efeitos adversos , Aterectomia/métodos , Dióxido de Carbono , Artéria Femoral , Humanos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Insuficiência Renal Crônica/complicações , Insuficiência Renal Crônica/diagnóstico , Insuficiência Renal Crônica/terapia , Estudos Retrospectivos , Resultado do Tratamento
5.
Catheter Cardiovasc Interv ; 97(3): E343-E345, 2021 Feb 15.
Artigo em Inglês | MEDLINE | ID: mdl-32433796

RESUMO

Coronavirus disease-2019 (COVID-19) pandemic is the biggest global health threat in the 21st century. We describe a case of a patient with suspected COVID-19 who needed urgent coronary artery interrogation, in which we utilized robotic assistance to minimize the risk of exposure to COVID-19 and reduced personal protective equipment needed by the procedural team.


Assuntos
COVID-19/diagnóstico , Controle de Infecções , Intervenção Coronária Percutânea , Procedimentos Cirúrgicos Robóticos , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Infarto do Miocárdio com Supradesnível do Segmento ST/virologia , COVID-19/complicações , COVID-19/terapia , Teste de Ácido Nucleico para COVID-19 , Feminino , Humanos , Transmissão de Doença Infecciosa do Paciente para o Profissional/prevenção & controle , Pessoa de Meia-Idade , Reação em Cadeia da Polimerase Via Transcriptase Reversa , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico
6.
Catheter Cardiovasc Interv ; 98(4): 743-747, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-33527695

RESUMO

Below the knee (BTK) peripheral arterial disease often presents with critical limb ischemia (CLI) clinically with involvement of more than one tibial vessels. Drug eluting stent (DES) technology for treatment of BTK disease has shown promising long-term durable results; however, currently only coronary DESs are available for application in the United States. Although coronary bifurcation stenting techniques are backed by extensive data in literature, there is a scarcity of data for the treatment of tibial bifurcation disease. Bifurcation angles in the tibials are similar to those in the coronaries and therefore the same two stent bifurcation technique can be applied in BTK disease. Double Kiss crush (DK crush) stenting has superior outcomes when compared to provisional or culotte stenting in randomized coronary trials (based on Medina classification). We present a case of BTK CLI with tibial bifurcation chronic total occlusion treated with two stent DK crush technique using coronary DES.


Assuntos
Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Angiografia Coronária , Humanos , Fatores de Risco , Stents , Artérias da Tíbia/diagnóstico por imagem , Artérias da Tíbia/cirurgia , Fatores de Tempo , Resultado do Tratamento
7.
Catheter Cardiovasc Interv ; 97(2): 292-298, 2021 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-32975377

RESUMO

OBJECTIVES: Determine the baseline clinical, laboratory, and echocardiographic values that predict reduced cardiac index (CI) among subjects with acute submassive pulmonary embolism (PE). BACKGROUND: Submassive PE represents a large portion of acute PE population and there is controversy regarding optimal treatment strategies for these patients. There is significant heterogeneity within the submassive PE population and further refinement of risk stratification may aid clinical decision-making. METHODS: We identified subjects with normotensive acute PE who underwent echocardiogram and right heart catheterization (RHC) prior to catheter-directed thrombolysis (CDT). We sought to determine the predictors of reduced CI, defined as CI < 2.2 L min-1 m-2 . RESULTS: Thirty-two subjects met the inclusion criteria and 41% had reduced CI. Baseline variables did not distinguish subjects with reduced versus normal CI. Brain natriuretic peptide (BNP) was significantly different between the reduced versus normal CI groups (BNP 440 vs. 160 pg/ml, p = .004, respectively). Univariate logistic regression identified BNP, right ventricular (RV):left ventricular (LV) diameter ratio, tricuspid annular plane systolic excursion (TAPSE), and right ventricular systolic pressure as predictors of reduced CI. In a multivariate logistic regression model, only TAPSE was an independent predictor of reduced CI. ROC curve analysis identified the following optimal cut points for prediction of reduced CI: BNP > 216 pg/ml, RV:LV ratio > 1.41, or TAPSE <1.6 cm. CONCLUSIONS: Almost half of subjects with acute submassive PE have reduced CI, despite normal systemic blood pressure. Optimal cut points for BNP, RV:LV ratio, and TAPSE were identified to predict reduced CI among patients with acute PE. These findings may aid in clinical decision-making and risk stratification of patients with acute submassive PE.


Assuntos
Embolia Pulmonar , Disfunção Ventricular Direita , Doença Aguda , Ecocardiografia , Humanos , Peptídeo Natriurético Encefálico , Embolia Pulmonar/diagnóstico por imagem , Embolia Pulmonar/terapia , Resultado do Tratamento
8.
Am Heart J ; 226: 174-187, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32599258

RESUMO

As the severe acute respiratory syndrome coronavirus 2 virus pandemic continues to grow globally, an association is apparent between patients with underlying cardiovascular disease comorbidities and the risk of developing severe COVID-19. Furthermore, there are potential cardiac manifestations of severe acute respiratory syndrome coronavirus 2 including myocyte injury, ventricular dysfunction, coagulopathy, and electrophysiologic abnormalities. Balancing management of the infection and treatment of underlying cardiovascular disease requires further study. Addressing the increasing reports of health care worker exposure and deaths remains paramount. This review summarizes the most contemporary literature on the relationship of the cardiovascular system and COVID-19 and society statements with relevance to protection of health care workers, and provides illustrative case reports in this context.


Assuntos
Betacoronavirus , Doenças Cardiovasculares/complicações , Infecções por Coronavirus/complicações , Pessoal de Saúde , Pandemias , Pneumonia Viral/complicações , Síndrome Coronariana Aguda/epidemiologia , Adulto , Fatores Etários , Idoso , Antagonistas de Receptores de Angiotensina/efeitos adversos , Antagonistas de Receptores de Angiotensina/uso terapêutico , Inibidores da Enzima Conversora de Angiotensina/efeitos adversos , Arritmias Cardíacas/etiologia , Biomarcadores/sangue , COVID-19 , Cateterismo Cardíaco , Reanimação Cardiopulmonar , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/mortalidade , Sistema Cardiovascular , Comorbidade , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/mortalidade , Infecções por Coronavirus/prevenção & controle , Eletrocardiografia , Evolução Fatal , Feminino , Hospitalização/estatística & dados numéricos , Hospitalização/tendências , Humanos , Masculino , Pessoa de Meia-Idade , Doenças Profissionais/epidemiologia , Doenças Profissionais/prevenção & controle , Pandemias/prevenção & controle , Equipamento de Proteção Individual , Pneumonia Viral/epidemiologia , Pneumonia Viral/mortalidade , Pneumonia Viral/prevenção & controle , SARS-CoV-2 , Função Ventricular
9.
Catheter Cardiovasc Interv ; 96(2): 410-412, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32369662

RESUMO

The use of robotic assistance in endovascular interventions may facilitate smoother procedures with fewer device manipulations, improve precision and accuracy of device deployment, and reduce exposure to fluoroscopic radiation. We used the CorPath GRX Robotic System for carotid balloon angioplasty and stent placement in a patient with limited surgical options.


Assuntos
Angioplastia com Balão/instrumentação , Estenose das Carótidas/terapia , Dispositivos de Proteção Embólica , Robótica , Stents , Idoso , Estenose das Carótidas/diagnóstico por imagem , Contraindicações de Procedimentos , Humanos , Masculino , Fatores de Risco , Resultado do Tratamento
10.
Catheter Cardiovasc Interv ; 95(2): E66-E70, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31313483

RESUMO

Femoropopliteal in-stent chronic total occlusions (CTOs) remain one of the most challenging subsets of peripheral arterial disease to treat percutaneously. Advances in available CTO crossing technology and operator experience have increased percutaneous intervention success rates. We report a case of critical limb ischemia in a patient with chronically occluded femoropopliteal nonoverlapping stents treated with a novel percutaneous approach of subintimal retrograde angioplasty using high compression resistant nitinol stents to crush the occluded previous stents to create a neo-lumen.


Assuntos
Procedimentos Endovasculares/instrumentação , Artéria Femoral , Claudicação Intermitente/terapia , Isquemia/terapia , Doença Arterial Periférica/terapia , Artéria Poplítea , Stents , Constrição Patológica , Estado Terminal , Procedimentos Endovasculares/efeitos adversos , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Claudicação Intermitente/diagnóstico por imagem , Claudicação Intermitente/fisiopatologia , Isquemia/diagnóstico por imagem , Isquemia/fisiopatologia , 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 , Retratamento , Resultado do Tratamento , Grau de Desobstrução Vascular
11.
Catheter Cardiovasc Interv ; 95(7): 1314-1319, 2020 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-31925989

RESUMO

Chronic total occlusion (CTO) of mesenteric arteries with associated chronic mesenteric ischemia (CMI) is associated with high morbidity and mortality. Endovascular intervention has been associated with high technical success with high rates of freedom from symptoms and long-term patency. However, to achieve high procedural success, use of optimal vascular access and expertise in CTO hybrid algorithm including advanced dissection reentry strategies are essential. We present a case of CMI from severe celiac artery (CA) stenosis and CTO of superior mesenteric artery (SMA) and inferior mesenteric artery (IMA). After treatment of CA stenosis, we were unsuccessful in our first attempt at recanalization of SMA CTO. On second attempt, left brachial artery (BA) access was obtained and the hybrid algorithm along with use of Stingray Reentry balloon (Boston Scientific) for dissection reentry into true lumen was successful in recanalizing the SMA CTO with placement of balloon expandable covered stents (CS). To the best of our knowledge, this is the first case report utilizing Sting-ray Reentry balloon in the mesenteric arteries.


Assuntos
Angioplastia com Balão/instrumentação , Artéria Celíaca , Artéria Mesentérica Superior , Isquemia Mesentérica/terapia , Oclusão Vascular Mesentérica/terapia , Stents , Dispositivos de Acesso Vascular , Idoso , Angioplastia com Balão/efeitos adversos , Artéria Celíaca/diagnóstico por imagem , Artéria Celíaca/fisiopatologia , Doença Crônica , Constrição Patológica , Humanos , Masculino , Artéria Mesentérica Superior/diagnóstico por imagem , Artéria Mesentérica Superior/fisiopatologia , Isquemia Mesentérica/diagnóstico por imagem , Isquemia Mesentérica/fisiopatologia , Oclusão Vascular Mesentérica/diagnóstico por imagem , Oclusão Vascular Mesentérica/fisiopatologia , Resultado do Tratamento
12.
Circ Res ; 121(11): 1263-1278, 2017 Nov 10.
Artigo em Inglês | MEDLINE | ID: mdl-28912121

RESUMO

RATIONALE: Cortical bone stem cells (CBSCs) have been shown to reduce ventricular remodeling and improve cardiac function in a murine myocardial infarction (MI) model. These effects were superior to other stem cell types that have been used in recent early-stage clinical trials. However, CBSC efficacy has not been tested in a preclinical large animal model using approaches that could be applied to patients. OBJECTIVE: To determine whether post-MI transendocardial injection of allogeneic CBSCs reduces pathological structural and functional remodeling and prevents the development of heart failure in a swine MI model. METHODS AND RESULTS: Female Göttingen swine underwent left anterior descending coronary artery occlusion, followed by reperfusion (ischemia-reperfusion MI). Animals received, in a randomized, blinded manner, 1:1 ratio, CBSCs (n=9; 2×107 cells total) or placebo (vehicle; n=9) through NOGA-guided transendocardial injections. 5-ethynyl-2'deoxyuridine (EdU)-a thymidine analog-containing minipumps were inserted at the time of MI induction. At 72 hours (n=8), initial injury and cell retention were assessed. At 3 months post-MI, cardiac structure and function were evaluated by serial echocardiography and terminal invasive hemodynamics. CBSCs were present in the MI border zone and proliferating at 72 hours post-MI but had no effect on initial cardiac injury or structure. At 3 months, CBSC-treated hearts had significantly reduced scar size, smaller myocytes, and increased myocyte nuclear density. Noninvasive echocardiographic measurements showed that left ventricular volumes and ejection fraction were significantly more preserved in CBSC-treated hearts, and invasive hemodynamic measurements documented improved cardiac structure and functional reserve. The number of EdU+ cardiac myocytes was increased in CBSC- versus vehicle- treated animals. CONCLUSIONS: CBSC administration into the MI border zone reduces pathological cardiac structural and functional remodeling and improves left ventricular functional reserve. These effects reduce those processes that can lead to heart failure with reduced ejection fraction.


Assuntos
Osso Cortical/citologia , Infarto do Miocárdio/cirurgia , Traumatismo por Reperfusão Miocárdica/cirurgia , Miocárdio/patologia , Células-Tronco/fisiologia , Função Ventricular Esquerda , Remodelação Ventricular , Animais , Apoptose , Arritmias Cardíacas/fisiopatologia , Arritmias Cardíacas/prevenção & controle , Proliferação de Células , Células Cultivadas , Modelos Animais de Doenças , Feminino , Hemodinâmica , Contração Miocárdica , Infarto do Miocárdio/patologia , Infarto do Miocárdio/fisiopatologia , Traumatismo por Reperfusão Miocárdica/patologia , Traumatismo por Reperfusão Miocárdica/fisiopatologia , Fenótipo , Volume Sistólico , Sus scrofa , Fatores de Tempo
13.
J Endovasc Ther ; 24(3): 342-348, 2017 06.
Artigo em Inglês | MEDLINE | ID: mdl-28351204

RESUMO

PURPOSE: To evaluate the safety and effectiveness of primary stenting of the common (CIA) or external iliac artery (EIA) using the Visi-Pro Balloon-Expandable Peripheral Stent System for treatment of stenotic, restenotic, or occluded lesions. METHODS: Between 2011 and 2012, 75 patients (mean age 64.2±8.9 years; 46 men) with Rutherford category 2-4 ischemia and atherosclerotic lesions ≤10 cm in length underwent iliac artery stenting at 17 centers in the United States and Europe. The primary outcome of the study was the major adverse event (MAE) rate at 9 months postprocedure [composite of periprocedural death, in-hospital myocardial infarction, clinically driven target lesion revascularization (CD-TLR), and amputation of the treated limb]. Secondary outcomes included 30-day MAE rate, 9-month primary patency, changes in ankle-brachial index (ABI) and the Walking Impairment Questionnaire at 30 days and 9 months postprocedure, device success, and clinically driven target vessel revascularization (CD-TVR) at 30 days and 9 months. Outcomes in specific patient cohorts (ie, gender, stent location, calcification severity, and lesion grade) were analyzed. RESULTS: Eighty-one stents were implanted in 61 CIA and 15 EIA lesions (41 with moderate/severe calcification). The mean lesion treated length was 29.3±13.9 mm. All devices were successfully deployed. MAE occurred in 3 (4.0%) of 75 subjects at 9 months. Primary patency and freedom from CD-TVR at 9 months were both 95.8%. ABI improved from 0.67±0.14 at baseline to 0.94±0.14 and 0.96±0.16 at 30 days and 9-month follow-up, respectively (p<0.001 for both). There were no differences with respect to any of the analyzed patient characteristics, including gender. CONCLUSION: Nine-month results of the VISIBILITY Iliac stent study ( ClinicalTrials.gov identifier NCT01402700) demonstrated safety and effectiveness for the treatment of atherosclerotic CIA and EIA lesions with the Visi-Pro stent across all treated cohorts.


Assuntos
Artéria Ilíaca , Doença Arterial Periférica/terapia , Idoso , Amputação Cirúrgica , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/instrumentação , Índice Tornozelo-Braço , Constrição Patológica , Intervalo Livre de Doença , Europa (Continente) , Feminino , Humanos , Artéria Ilíaca/diagnóstico por imagem , Artéria Ilíaca/fisiopatologia , Estimativa de Kaplan-Meier , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Estudos Prospectivos , Fatores de Risco , Índice de Gravidade de Doença , Stents , Inquéritos e Questionários , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Grau de Desobstrução Vascular
14.
J Endovasc Ther ; 24(3): 355-366, 2017 06.
Artigo em Inglês | MEDLINE | ID: mdl-28393673

RESUMO

PURPOSE: To evaluate the safety and efficacy of a novel optical coherence tomography (OCT)-guided atherectomy catheter in treating patients with symptomatic femoropopliteal disease. METHODS: The VISION trial ( ClinicalTrials.gov identifier NCT01937351) was a single-arm, multicenter, global investigational device exemption study enrolling 158 subjects (mean age 67.2±10.5 years; 87 men) across 20 participating sites. In this cohort, 198 lesions were treated with an average length of 53±40 mm using the Pantheris catheter alone or Pantheris + adjunctive therapy. The primary safety endpoint was the composite of major adverse events (MAEs) through 6 months (objective performance goal 43.2%). Technical success (primary efficacy outcome) was defined as the percent of target lesions with a residual diameter stenosis ≤50% after treatment with the Pantheris device alone (objective performance goal 87.0%). Procedural success was defined as reduction in stenosis to ≤30% after Pantheris ± adjunctive therapy. Tissue specimens retrieved from each treated lesion were histologically analyzed to evaluate the accuracy and precision of OCT image guidance. RESULTS: The primary efficacy outcome was achieved in 192 (97.0%) of the 198 lesions treated with the Pantheris catheter. Across all lesions, mean diameter stenosis was reduced from 78.7%±15.1% at baseline to 30.3%±11.8% after Pantheris alone (p<0.001) and to 22.4%±9.9% after Pantheris ± adjunctive therapy (p<0.001). Of the 198 target lesions, 104 (52.5%) were treated with the Pantheris alone, 84 (42.4%) were treated with Pantheris + adjunctive angioplasty, and 10 (5.1%) with Pantheris + angioplasty + stenting. The composite MAE outcome through 6 months occurred in 25 (16.6%) of 151 subjects. There were no clinically significant perforations, 1 (0.5%) catheter-related dissection, 4 (2%) embolic events, and a 6.4% clinically driven target lesion revascularization rate at 6 months. The 40-lesion chronic total occlusion (CTO) subset (mean lesion length 82±38 mm) achieved a similar significant reduction in stenosis to 35.5%±13.6% after Pantheris alone (p<0.001). Histological analysis of atherectomy specimens confirmed <1% adventitia in 82.1% of the samples, highlighting the precision of OCT guidance. Characterization of the OCT-guided lesions revealed evidence of an underestimation of disease burden when using fluoroscopy. CONCLUSION: OCT-guided atherectomy for femoropopliteal disease is safe and effective. Additionally, the precision afforded by OCT guidance leads to greater removal of plaque during atherectomy while sparing the adventitia.


Assuntos
Aterectomia/métodos , Artéria Femoral/diagnóstico por imagem , Extremidade Inferior/irrigação sanguínea , Doença Arterial Periférica/terapia , Artéria Poplítea/diagnóstico por imagem , Tomografia de Coerência Óptica/métodos , Idoso , Angioplastia/instrumentação , Aterectomia/efeitos adversos , Aterectomia/instrumentação , Competência Clínica , Constrição Patológica , Desenho de Equipamento , Feminino , Artéria Femoral/fisiopatologia , Alemanha , Humanos , Curva de Aprendizado , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/fisiopatologia , Valor Preditivo dos Testes , Estudos Prospectivos , Stents , Fatores de Tempo , Tomografia de Coerência Óptica/instrumentação , Resultado do Tratamento , Estados Unidos , Dispositivos de Acesso Vascular
16.
J Interv Cardiol ; 29(6): 612-618, 2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-27492647

RESUMO

BACKGROUND: Percutaneous balloon aortic valvuloplasty (PBAV) is a palliative therapeutic option for relief of severe aortic stenosis (AS) in patients that are poor surgical or transcatheter aortic valve replacement (TAVR) candidates or as a bridge to definitive therapy. The outcomes following PBAV are highly variable and studies identifying factors that correlate with outcomes are sparse. The purpose of this study was to identify predictors at the time of the index procedures that can predict 1-year survival or need for repeat PBAV. METHODS: Demographic and procedural information of 505 PBAVs performed on 388 patients from January 1999 to December 2012 at the Deborah Heart and Lung Center were reviewed. Procedural data were compared across many variables and outcomes to identify predictors of outcomes. These predictors were statistically compared using chi-squared tests or Student's t-test. RESULTS: Of the 388 patients analyzed, 145 (37.4%) expired within 1 year following the index procedure. The cohort was then stratified into 3 groups based on the number of balloon inflations. They were similar with regard to baseline characteristics. The mean age was 81.9 ± 9 years. Males constituted 51% of the cohort. Patients who underwent 2 and 3+ inflations had a 47.6% and 93.0% increase in the postprocedural aortic valve area compared to patients who had only 1 inflation. Patients who underwent 3+ inflations were significantly less likely to require a repeat PABV within a year and the repeat procedure free survival rate of 94.5% (P = 0.009). Despite improvement in valve area, there was no statistically significant difference in 1 year mortality between the groups (28.8% vs 42.9% vs 46.1% for 1 vs 2 vs 3+ inflations, respectively). CONCLUSIONS: PBAV provides a modest improvement in valve function and continues to be a safe and feasible option in experienced hands for select patients that are high risk for surgery or TAVR. The use of additional inflations during PBAV resulted in better long-term outcomes.


Assuntos
Estenose da Valva Aórtica , Valva Aórtica , Valvuloplastia com Balão , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/cirurgia , Valvuloplastia com Balão/efeitos adversos , Valvuloplastia com Balão/métodos , Feminino , Humanos , Masculino , Avaliação de Processos e Resultados em Cuidados de Saúde , Seleção de Pacientes , Prognóstico , Reoperação/métodos , Reoperação/estatística & dados numéricos , Estudos Retrospectivos , Risco Ajustado/métodos , Taxa de Sobrevida , Resultado do Tratamento , Estados Unidos/epidemiologia
18.
J Endovasc Ther ; 22(3): 319-26, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25862365

RESUMO

PURPOSE: To determine the risk factors and clinical impact of stent fractures after superficial femoral artery (SFA) stenting. METHODS: From May 2009 to June 2012, 171 consecutive patients (mean age 74.5±7.8, years; 106 men) who presented with SFA stenosis or occlusion in 205 limbs underwent stent implantation in the SFA at a single center. Stent fractures were determined by radiography and classified into types I through V. Loss of patency was assessed by duplex ultrasonography (>2.4 peak systolic velocity ratio) or angiography (percent diameter stenosis >50%). RESULTS: The 12- and 24-month primary patency rates were 49.8% and 43.4%, respectively. Stent fractures occurred in 12.5% and 26.8% per limb (6.6% and 19.4% per stent) at 12 and 24 months, respectively. Primary patency was numerically worse in the stent fracture group but not statistically different from the group without fractures at 2 years. Primary patency for different classes of stent fracture were 30.8% (type I), 50.0% (type II), and 31.3% (type III-V). Hyperlipidemia (p=0.001), TransAtlantic Inter-Society Consensus II classification (p=0.007), chronic total occlusion (CTO; p<0.001), proximal lesion location (p=0.008), lesion calcification (p=0.025), total stent length (p=0.005), stent diameter (p=0.001), and number of stents (p=0.001) were statistically significant predictors of stent fracture. Multivariate analysis showed that CTO (hazard ratio 0.173, 95% confidence interval 0.042 to 0.716, p=0.015) was an independent predictor of stent fracture. CONCLUSION: Stent fractures occur more frequently in patients with CTOs after treatment of longer stented lesions. Although multivariate analysis showed that CTO was the only independent predictor regardless of stent length or number, the stent fracture rate was numerically higher in the severe calcification and proximal SFA lesion subgroups. Stent fracture did not appear to affect long-term patency rates, but this is yet to be confirmed with further follow-up.


Assuntos
Procedimentos Endovasculares/instrumentação , Artéria Femoral/fisiopatologia , Doença Arterial Periférica/terapia , Falha de Prótese , Stents , Grau de Desobstrução Vascular , Idoso , Idoso de 80 Anos ou mais , Doença Crônica , Bases de Dados Factuais , Procedimentos Endovasculares/efeitos adversos , Feminino , Artéria Femoral/diagnóstico por imagem , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/fisiopatologia , Modelos de Riscos Proporcionais , Desenho de Prótese , Radiografia , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Ultrassonografia Doppler Dupla , Calcificação Vascular/diagnóstico , Calcificação Vascular/fisiopatologia , Calcificação Vascular/terapia
19.
J Vasc Interv Radiol ; 25(6): 954-61, 2014 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-24768325

RESUMO

PURPOSE: To report experience with the novel interwoven-wire self-expanding nitinol SUPERA stent (IDEV Technologies, Inc/Abbott Laboratories, Inc, Webster, Texas) for the treatment of severely diseased superficial femoral and popliteal arteries. MATERIALS AND METHODS: Consecutive patients with severely diseased superficial femoral and popliteal arteries who received SUPERA stents (n = 80 patients [98 limbs]; mean age, 70.8 y; 80% male) were retrospectively identified. Patients were followed for an average of 14.3 months after intervention. RESULTS: Total occlusions were present in 39% of the lesions, 21% had tissue loss, and 61% demonstrated calcification on fluoroscopy. Patients were prescribed dual antiplatelet therapy (aspirin and clopidogrel) for at least 30 days unless contraindicated, followed by aspirin alone indefinitely. The mean (± SD) lesion length was 143 mm (± 98). Based on need for clinical intervention, primary patency was 96.9% at 6 months and 85.8% at 12 months (Kaplan-Meier estimates). Assisted primary patency and secondary patency rates at 12 months were 96.8% and 100%, respectively. Ankle-brachial index increased from 0.60 at baseline to 0.83 at last follow-up (P < .001). No stent fractures were found by fluoroscopy inspection in 19 limbs (16 patients) that required reintervention. CONCLUSIONS: Based on experience with multiple operators at a single clinical center, the interwoven nitinol stent design provides a viable option for high-grade obstructive disease in the femoropopliteal artery.


Assuntos
Ligas , Procedimentos Endovasculares/instrumentação , Artéria Femoral , Doença Arterial Periférica/terapia , Artéria Poplítea , Stents , Idoso , Idoso de 80 Anos ou mais , Índice Tornozelo-Braço , Aspirina/administração & dosagem , Clopidogrel , Constrição Patológica , Quimioterapia Combinada , Procedimentos Endovasculares/efeitos adversos , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/fisiopatologia , Inibidores da Agregação Plaquetária/administração & dosagem , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Valor Preditivo dos Testes , Desenho de Prótese , Radiografia , Estudos Retrospectivos , Índice de Gravidade de Doença , Ticlopidina/administração & dosagem , Ticlopidina/análogos & derivados , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular
20.
J Ultrasound Med ; 33(3): 387-95, 2014 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-24567449

RESUMO

Intracardiac echocardiography (ICE) uses a catheter-based steerable ultrasound probe that is passed into the right heart chambers to image intracardiac structures. The transducer can be variably positioned for optimal imaging: in the inferior vena cava to visualize the abdominal aorta; in the right atrium for the interatrial septum, aortic, mitral, and tricuspid valves, and pulmonary veins; or in the right ventricle for the left ventricular function, outflow tract, or pulmonary artery. Intracardiac echocardiography is primarily used for imaging during an invasive cardiac procedure using conscious sedation, when transthoracic image quality would likely be inadequate, and transesophageal imaging would require general anesthesia. Intracardiac echocardiography is generally well tolerated and provides adequate images and sufficient information for the procedure performed. In the cardiac catheterization laboratory, ICE is routinely used for patent foramen ovale, atrial septal defect, and ventricular septal defect closures, allowing adequate percutaneous placement of septal occluders. It is now being considered in the current era of transcatheter aortic valve implantation necessitating improved imaging approaches for accurate placement. It is also routinely used for trans-septal punctures during mitral valvuloplasty and, more recently, with the advent of left atrial appendage closure devices. This article provides a comprehensive review of the current technology for ICE and its growing applications in the realm of interventional cardiology.


Assuntos
Procedimentos Cirúrgicos Cardiovasculares/métodos , Ecocardiografia/métodos , Endossonografia/métodos , Cirurgia Assistida por Computador/métodos , Ultrassonografia de Intervenção/métodos , Humanos
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