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1.
IEEE Trans Biomed Eng ; 70(9): 2540-2551, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37028021

RESUMO

OBJECTIVE: Development of a contact microphone-driven screening framework for the diagnosis of coexisting valvular heart diseases (VHDs). METHODS: A sensitive accelerometer contact microphone (ACM) is employed to capture heart-induced acoustic components on the chest wall. Inspired by the human auditory system, ACM recordings are initially transformed into Mel-frequency cepstral coefficients (MFCCs) and their first and second derivatives, resulting in 3-channel images. An image-to-sequence translation network based on the convolution-meets-transformer (CMT) architecture is then applied to each image to find local and global dependencies in images, and predict a 5-digit binary sequence, where each digit corresponds to the presence of a specific type of VHD. The performance of the proposed framework is evaluated on 58 VHD patients and 52 healthy individuals using a 10-fold leave-subject-out cross-validation (10-LSOCV) approach. RESULTS: Statistical analyses suggest an average sensitivity, specificity, accuracy, positive predictive value, and F1 score of 93.28%, 98.07%, 96.87%, 92.97%, and 92.4% respectively, for the detection of coexisting VHDs. Furthermore, areas under the curve (AUC) of 0.99 and 0.98 are respectively reported for the validation and test sets. CONCLUSION: The high performances achieved prove that local and global features of ACM recordings effectively characterize heart murmurs associated with valvular abnormalities. SIGNIFICANCE: Limited access of primary care physicians to echocardiography machines has resulted in a low sensitivity of 44% when using a stethoscope for the identification of heart murmurs. The proposed framework provides accurate decision-making on the presence of VHDs, thus reducing the number of undetected VHD patients in primary care settings.


Assuntos
Doenças das Valvas Cardíacas , Humanos , Doenças das Valvas Cardíacas/diagnóstico por imagem , Sopros Cardíacos/diagnóstico , Auscultação Cardíaca , Ecocardiografia , Valor Preditivo dos Testes
2.
J Endovasc Ther ; 30(5): 711-720, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-35503774

RESUMO

PURPOSE: To investigate the clinical implication of additional below-the-ankle (BTA) intervention in patients with chronic limb-threatening ischemia (CLTI) undergoing below-the-knee (BTK) intervention. MATERIALS AND METHODS: A sub-analysis was performed using data from the LIBERTY trial (ClinicalTrials.gov identifier NCT01855412), a prospective, observational, core-laboratory adjudicated, multicenter study of endovascular intervention in 1204 patients. Patients with CLTI (Rutherford Classification 4-6) who underwent BTK intervention were included in this sub-analysis. Participants were then stratified into 2 treatment groups according to whether at least one lesion intervened on was BTA (n=66) or not (n=273). The decision on whether and where to intervene was made during the procedure. The main outcome measures included major amputation, target vessel revascularization (TVR), major adverse events (MAE), survival, amputation-free survival, major adverse limb events or peri-operative death (MALE-POD), and all-cause death. Other outcome measures included procedural success, procedural complications, and wound healing rate. RESULTS: There were no differences in procedural success or severe angiographic complications between the 2 groups. At 1-year post-procedure, patients in the BTK group had a higher rate of freedom from major amputation (95.0% vs. 86.9%, respectively; HR: 2.87, 95% CI: 1.17-7.03), a higher rate of freedom from TVR (80.1% vs. 66.9%, respectively; HR: 1.94, 95% CI: 1.14-3.32), a higher rate of freedom from MALE-POD (94.6% vs. 86.9%, respectively; HR: 2.65, 95% CI: 1.10-6.41), and a higher rate of freedom from MAE at both 1 (76.0% vs. 60.1%, respectively; HR: 2.00, 95% CI: 1.24-3.22) and 3 years post procedure (67.5% vs. 55.8%, respectively; HR: 1.69, 95% CI: 1.08-2.65). There was a significantly lower rate of survival in the BTK group at 3 years (74.3% vs. 91.1%, respectively; HR: 0.35, 95% CI: 0.14-0.87). After risk adjustment, there was a higher rate of all-cause death in the BTK group at 3 years (19.4% vs. 9.1%, respectively; p=0.023) post-intervention. CONCLUSION: Patients with disease requiring intervention to BTA lesions have a potential increased amputation rate in the short term, but BTA intervention carries a potential survival benefit in the long term when compared to BTK intervention alone.


Assuntos
Tornozelo , Extremidade Inferior , Humanos , Estudos Prospectivos , Resultado do Tratamento , Extremidade Inferior/irrigação sanguínea , Cicatrização
3.
IEEE J Biomed Health Inform ; 27(1): 274-285, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-36318550

RESUMO

OBJECTIVE: The development of an accurate, non-invasive method for the diagnosis of peripheral artery disease (PAD) from accelerometer contact microphone (ACM) recordings of the cardiac system. METHODS: Mel frequency cepstral coefficients (MFCCs) are initially extracted from ACM recordings. The extracted MFCCs are then used to fine-tune a pre-trained ResNet50 network whose middle layers provide streams of high-level-of-abstraction coefficients (HLACs) which could provide information on blood pressure backflow caused by arterial obstructions in PAD patients. A vision transformer is finally integrated with the feature extraction layer to detect PAD, and stratify the severity level. This architecture is coined multi-stream-powered vision transformer (MSPViT). The performance of MSPViT is evaluated on 74 PAD and 21 healthy subjects. RESULTS: Sensitivity, specificity, F1 score, and area under the curve (AUC) of 99.45%, 98.21%, 99.37%, and 0.99, respectively, are reported for the binary classification which ensures accurate detection of PAD. Furthermore, MSPViT suggests average sensitivity, specificity, F1 score, and AUC of 96.66%, 97.34%, 96.29%, and 0.96, respectively, for the classification of subjects into healthy, mild-PAD, and severe-PAD classes. The silhouette score is calculated to assess the separability of clusters formed for classes in the penultimate layer of MSPViT. An average silhouette score of 0.66 and 0.81 demonstrate excellent cluster separability in PAD detection and severity classification, respectively. CONCLUSION: The achieved performance suggests that the proximal ACM-driven framework can replace state-of-the-art techniques for PAD detection. SIGNIFICANCE: This study presents a fundamental step towards prompt and accurate diagnosis of PAD and stratification of its severity level.


Assuntos
Doença Arterial Periférica , Humanos , Pressão Sanguínea , Acelerometria
4.
CVIR Endovasc ; 4(1): 9, 2021 Jan 06.
Artigo em Inglês | MEDLINE | ID: mdl-33409988

RESUMO

BACKGROUND: Transpedal access is increasingly utilized for the treatment of peripheral artery disease (PAD). Femoral-popliteal artery chronic total occlusions (CTOs) are some of the most difficult lesion subsets that sometimes require the use of re-entry support devices during percutaneous intervention. Limited data is available on the use of re-entry devices when treating femoral-popliteal CTOs via transpedal access. The aim of this study was to demonstrate the feasibility of using the Outback® Elite re-entry device for the treatment of femoral-popliteal CTOs via the transpedal approach in an outpatient based lab setting. METHODS: Seventeen patients presented with femoral-popliteal CTOs in which treatment required the use of the Outback® Elite re-entry device. All procedures were performed in a single outpatient based lab. Patients were followed at 1 week and 1 month post-procedure, with lower extremity arterial duplex ultrasound assessment during the 1 month follow-up. RESULTS: The average patient age was 78 years-old, with 71% being males. Most patients presented with Rutherford class IV symptoms. Procedural success was achieved in all patients with no requirement to convert to femoral artery access in any of the cases. No immediate post-procedural complications nor at any time during follow-up were observed. Ultrasonography at 1 month follow-up showed patent intervention sites and access site vessels in all patients. CONCLUSION: The use of the Outback® Elite re-entry device for the treatment of femoral-popliteal CTOs via transpedal access is a feasible option and may have potential benefits by avoiding risks associated with traditional femoral artery access.

5.
JACC Case Rep ; 2(3): 454-455, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-34317262

RESUMO

We describe a rare case of an exceptionally large pseudoaneurysm that developed in the right common femoral artery 6 months after an electrophysiological study. Surgical and other conventional methods to treat his pseudoaneurysm were not feasible. Therefore, the pseudoaneurysm was successfully treated via an endovascular approach with a covered stent. (Level of Difficulty: Beginner.).

6.
J Med Case Rep ; 13(1): 282, 2019 Sep 08.
Artigo em Inglês | MEDLINE | ID: mdl-31493785

RESUMO

BACKGROUND: A pseudoaneurysm is a rare but serious complication after transradial coronary catheterization. Although different treatment modalities have been proposed to treat post-catheterization pseudoaneurysm, only limited data are available to guide the treatment approach. CASE PRESENTATION: We report a rare case of two distinct pseudoaneurysms complicating transradial percutaneous coronary intervention in a 75-year-old Hispanic woman being treated with dual antiplatelet agents for myocardial infarction and warfarin for atrial fibrillation. The pseudoaneurysms were diagnosed with ultrasound and were successfully treated with a series of Terumo Corporation (TR) band compressions. CONCLUSIONS: This case demonstrates the efficacy of compression therapy in managing post-catheterization radial artery pseudoaneurysm in patients with high bleeding risk.


Assuntos
Falso Aneurisma/diagnóstico por imagem , Cateterismo Cardíaco/efeitos adversos , Artéria Radial/diagnóstico por imagem , Idoso , Fibrilação Atrial/tratamento farmacológico , Terapia Antiplaquetária Dupla , Feminino , Humanos , Infarto do Miocárdio/tratamento farmacológico , Intervenção Coronária Percutânea , Ultrassonografia Doppler Dupla
7.
Cardiovasc Revasc Med ; 20(6): 454-460, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30982659

RESUMO

BACKGROUND: Direct stenting offers many potential advantages in appropriately selected lesions. Coronary artery calcification increases the complexity and risk of adverse events associated with percutaneous coronary intervention. This study aimed to examine the feasibility of direct stenting after treatment with orbital atherectomy (OA). METHODS: ORBIT II was a single-arm trial enrolling 443 subjects with de novo severely calcified coronary lesions treated with OA; direct stenting was utilized in 59.0% of cases. Procedural outcomes and 3-year major adverse cardiac event (MACE) rates were compared in subjects treated with pre-stent balloon dilatation versus direct stenting after OA. RESULTS: Procedural success (84.2% vs. 93.3%; p = 0.004) was significantly higher in the direct stenting cohort. 3-year MACE occurred less frequently in the direct stenting cohort (29.9% vs. 19.1%; p = 0.006), driven by lower rates of myocardial infarction and target lesion revascularization. In a propensity matched analysis, procedural success and 3-year MACE rates were similar in the pre-stent balloon dilatation and direct stenting groups (85.0% vs. 91.8%; p = 0.122 and 28.2% vs. 19.6%; p = 0.078, respectively). CONCLUSIONS: Orbital atherectomy facilitates direct stenting and is associated with high procedural success and favorable 3-year outcomes in carefully selected patients. Randomized studies are needed to assess the optimal strategy after lesion preparation with OA.


Assuntos
Angioplastia Coronária com Balão/instrumentação , Aterectomia Coronária , Doença da Artéria Coronariana/terapia , Stents , Calcificação Vascular/terapia , Idoso , Idoso de 80 Anos ou mais , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/mortalidade , Aterectomia Coronária/efeitos adversos , Aterectomia Coronária/mortalidade , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/mortalidade
8.
CVIR Endovasc ; 2(1): 42, 2019 Dec 13.
Artigo em Inglês | MEDLINE | ID: mdl-32026158

RESUMO

BACKGROUND: With the advent of endovascular techniques, alternate sites such as the pedal and radial arteries can now be accessed when treating peripheral arterial disease to reduce procedural complications, shorten recovery time, and improve patient comfort. However, a paucity of literature exists on the availability of support devices that can be utilized during challenging cases. CASE PRESENTATION: A 70 year-old female patient presented for evaluation of severe lifestyle-limiting left-sided claudication refractory to maximal medical therapy. Angiography revealed a chronic total occlusion of the left external iliac artery, which was treated successfully by percutaneous intervention via a primary transpedal approach and with the assistance of the Outback® Elite re-entry device. The patient was discharged 2 h after the procedure and reported significant symptom improvement at follow-up. CONCLUSION: This case highlights a newly adopted endovascular approach through an alternate access site and illustrates how the Outback® Elite device can be used as an adjunctive tool in the treatment of complex lower-extremity vascular lesions.

9.
Catheter Cardiovasc Interv ; 92(7): 1338-1344, 2018 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-30019836

RESUMO

BACKGROUND: Improved equipment and techniques have resulted in transition from surgical bypass to endovascular intervention to treat superficial femoral artery (SFA) chronic total occlusions (CTO). A change in access site to radial (TRA) or tibiopedal (TPA) artery for the treatment of these SFA CTO has been reported. The feasibility, efficacy and safety of these two access sites for treatment of SFA CTO have not been reported. METHODS: We performed an as treated analysis of 184 SFA CTO interventions in 161 patients from 01/2014 to 09/2016 using either primary TRA or TPA (operator discretion) at two institutions. Primary end point was 30 day major adverse event (MAE) - death, amputation or target vessel revascularization, secondary endpoint was success of procedure. RESULTS: Primary TRA was used in 46 patients with 47 CTO lesions .Primary TPA was used in 115 patients with 137 CTO lesions. Primary crossing success rate was higher with TRA compared to TPA (74% vs 54%, P = 0.01). Dual TRA-TPA was required in 72 prior uncrossed lesions resulting in a crossing and procedural success of 99% and 96% respectively. The overall crossing and procedural success rate using either of these approaches was 99% and 98% respectively. The 30 day MAE was 5% in TRA arm, 0% in TPA arm and 2% in dual TRA-TPA arm, P = 0.08. All access sites were patent, confirmed by ultrasound. CONCLUSION: The treatment of SFA CTO is feasible and safe using both TRA or TPA approach providing high success rates and no access site complications.


Assuntos
Cateterismo Periférico/métodos , Procedimentos Endovasculares , Artéria Femoral , Doença Arterial Periférica/terapia , Artéria Radial , Artérias da Tíbia , Idoso , Idoso de 80 Anos ou mais , Amputação Cirúrgica , Cateterismo Periférico/efeitos adversos , Cateterismo Periférico/mortalidade , Doença Crônica , Constrição Patológica , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Estudos de Viabilidade , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Hungria , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Cidade de Nova Iorque , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
10.
J Interv Cardiol ; 30(6): 570-576, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-28786143

RESUMO

OBJECTIVES: We sought to assess the clinical outcomes when intravascular ultrasound (IVUS) was used prior to orbital atherectomy treatment (OA) versus angiography alone for lesion assessment. BACKGROUND: Percutaneous coronary intervention (PCI) of severely calcified lesions is associated with high rates of major adverse cardiac events (MACE). IVUS provides additional diagnostic information to optimize PCI. METHODS: ORBIT II was a single-arm study of 443 patients with de novo, severely calcified coronary lesions treated with OA before stent placement. Patients with IVUS imaging prior to OA (N = 35) were compared to patients without IVUS imaging for initial lesion assessment (N = 405). In this post-hoc sub-analysis procedural outcomes and the 3-year MACE rate were evaluated. RESULTS: The rates of severe angiographic complications were low in patients with and without IVUS imaging prior to OA. There was a significant reduction in the number of stents used in patients with IVUS imaging prior to OA (1.0 ± 0.2 vs 1.3 ± 0.6; P = 0.006) and increased post-OA mean minimal lumen diameter (MLD) (1.6 ± 0.6 mm vs 1.2 ± 0.5 mm; P < 0.001). The 3-year MACE rate was similar in both groups (IVUS: 14.3% vs No IVUS: 24.2%; P = 0.26). CONCLUSIONS: There were significantly fewer stents placed, increased post-OA MLD, and similar 3-year MACE outcomes in patients with IVUS assessment of the degree of lesion calcification prior to OA as compared to patients with angiographic assessment of the degree of lesion calcification. Further studies are needed to determine the optimal integration of intravascular imaging with OA.


Assuntos
Aterectomia Coronária/métodos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Ultrassonografia de Intervenção , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/terapia , Idoso , Angiografia Coronária , Feminino , Humanos , Masculino , Estudos Prospectivos
11.
Cardiovasc Revasc Med ; 18(2): 123-127, 2017 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-27842902

RESUMO

BACKGROUND: There has been an increasing use of transpedal arterial access (TPA) for evaluation and treatment of peripheral arterial disease (PAD) over a transfemoral approach (TFA). TPA, it is expected to be associated with better patient comfort, less recovery time and possibly less access site complications compared to standard TFA. Access site complications and pseudoaneurysm (PSA) associated with the TPA have not been previously reported. OBJECTIVE: Here we report a series of pedal artery PSA related to access site complicating TPA catheterization. METHODS: We studied 1460 patients with symptomatic PAD who underwent 2236 peripheral diagnostic and/or interventional procedures between 06/2014 and 01/2016 via TPA. Hemostasis was achieved using patent hemostasis technique by a radial artery compression device for 2h. PSA related to the access site were suspected clinically and confirmed with arterial duplex ultrasound. RESULTS: The incidence of PSA related to any access site was 0.002%. In this series all PSA occurred only in the posterior tibial artery, after an interventional procedure. All patients were treated successfully with thrombin injection with no residual complications. CONCLUSIONS: PSA associated with TPA is extremely rare and seems to occur exclusively after posterior tibial artery access. It is easily treatable by thrombin injection.


Assuntos
Falso Aneurisma/etiologia , Cateterismo Cardíaco/efeitos adversos , Artéria Femoral/cirurgia , Doença Arterial Periférica/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Falso Aneurisma/diagnóstico , Cateterismo Cardíaco/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico , Trombina/administração & dosagem , Trombina/uso terapêutico , Resultado do Tratamento , Ultrassonografia Doppler Dupla/métodos
12.
Cardiovasc Revasc Med ; 17(8): 556-559, 2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-27717580

RESUMO

OBJECTIVE: To demonstrate the safety and feasibility of the transpedal approach as an alternate arterial access site for iliac artery intervention. BACKGROUND: The common femoral artery is the traditional access site for the endovascular treatment of iliac artery stenoses. However, this approach is associated with complication rates as high as 2%, including retroperitoneal bleeding which carries high patient morbidity and mortality. Furthermore, the standard femoral approach is associated with longer recovery times and longer time to ambulation which are important considerations especially when performing procedures in an ambulatory setting. METHODS: Twelve patients were prospectively followed after treatment for symptomatic iliac artery stenosis via transpedal access. Under ultrasound guidance, one of the pedal arteries was visualized and accessed, and stenting of the iliac arteries were performed as per protocol. The patient was monitored immediately post procedure and clinical follow up was performed at one week and one month later. RESULTS: The average age of the patients was 71years old. 58% were male. Most patients had Rutherford class III symptoms. Successful stent placement was achieved in all 12 patients via transpedal access. No conversion to femoral access was required. No complications immediately post procedure nor at any time period during follow up were noted. Lower extremity arterial duplex at one month showed patent stents and patent pedal access site vessels in all patients. CONCLUSION: Transpedal arterial access may be a safe and feasible approach for iliac artery stenting. Given the possible benefits of avoiding femoral artery access, larger studies should be conducted directly comparing the different approaches.


Assuntos
Cateterismo Periférico/métodos , Procedimentos Endovasculares/instrumentação , Pé/irrigação sanguínea , Artéria Ilíaca , Doença Arterial Periférica/terapia , Stents , Idoso , Idoso de 80 Anos ou mais , Assistência Ambulatorial , Cateterismo Periférico/efeitos adversos , Bases de Dados Factuais , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/métodos , Estudos de Viabilidade , Feminino , Humanos , Artéria Ilíaca/diagnóstico por imagem , Artéria Ilíaca/fisiopatologia , Masculino , Pessoa de Meia-Idade , Cidade de Nova Iorque , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Projetos Piloto , Estudos Prospectivos , Fatores de Tempo , Resultado do Tratamento , Ultrassonografia Doppler Dupla , Grau de Desobstrução Vascular
13.
J Interv Cardiol ; 29(4): 424-30, 2016 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-27356488

RESUMO

BACKGROUND: Transpedal access is increasingly utilized for peripheral vascular catheterization. There is a paucity of data on the use of radial hemostasis devices as an alternative to manual compression for achievement of hemostasis after this approach. OBJECTIVE: To compare safety and efficacy of two hemostasis devices following transpedal catheterization for lower extremity revascularization for peripheral arterial disease. METHODS: A consecutive cohort of patients with bilateral Rutherford 2-5 disease who underwent transpedal catheterization for peripheral vascular interventions were retrospectively analyzed. In each patient, retrograde tibial artery access was obtained, a 4 French sheath was placed, and all revascularization was performed via tibial access. In all patients, a TR Band™ (Terumo Medical, n = 215) and/or VasoStat™ (Forge Medical, n = 99) were used to apply puncture site compression, following removal of the tibial sheath until hemostasis was achieved. Safety and efficacy of each device was compared. RESULTS: Puncture site hemostasis was achieved in all patients within 2 hours of sheath removal facilitating early discharge. Two access site pseudoaneurysms occurred within 30 days of revascularization, one of which followed TR Band™ placement and the other following VasoStat™ placement (P = 0.53). Each patient was successfully treated with ultrasound-guided thrombin injection. Loss of access site patency by duplex ultrasound occurred in 2 patients following the TR Band™ and a single patient following the VasoStat™ (P = 1.0). CONCLUSION: Both the TR Band™ and the VasoStat™ were effective in achieving hemostasis following transpedal catheterization with low rates of complications.


Assuntos
Falso Aneurisma , Cateterismo Periférico , Hemostasia Cirúrgica , Técnicas Hemostáticas/instrumentação , Doença Arterial Periférica , Complicações Pós-Operatórias , Artérias da Tíbia/cirurgia , Idoso , Falso Aneurisma/diagnóstico , Falso Aneurisma/etiologia , Falso Aneurisma/prevenção & controle , Cateterismo Periférico/efeitos adversos , Cateterismo Periférico/métodos , Pesquisa Comparativa da Efetividade , Feminino , Hemostasia Cirúrgica/efeitos adversos , Hemostasia Cirúrgica/instrumentação , Hemostasia Cirúrgica/métodos , Humanos , Extremidade Inferior/irrigação sanguínea , Masculino , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/cirurgia , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/prevenção & controle , Resultado do Tratamento
14.
JACC Cardiovasc Interv ; 7(5): 510-8, 2014 May.
Artigo em Inglês | MEDLINE | ID: mdl-24852804

RESUMO

OBJECTIVES: The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial evaluated the safety and efficacy of the coronary Orbital Atherectomy System (OAS) to prepare de novo, severely calcified coronary lesions for stent placement. BACKGROUND: Despite advances in interventional techniques, treatment of calcified coronary lesions remains a challenge. Stent placement in these lesions may result in stent underexpansion, malapposition, and procedural complications. METHODS: ORBIT II is a prospective, multicenter, nonblinded clinical trial that enrolled 443 consecutive patients with severely calcified coronary lesions at 49 U.S. sites from May 25, 2010, to November 26, 2012. Investigators used the centrifugal action of the OAS diamond-coated crown to modify calcified lesions prior to stent placement. RESULTS: The pre-procedure mean minimal lumen diameter of 0.5 mm increased to 2.9 mm after the procedure. The primary safety endpoint was 89.6% freedom from 30-day major adverse cardiac events compared with the performance goal of 83%. The primary efficacy endpoint (residual stenosis <50% post-stent without in-hospital major adverse cardiac events) was 88.9% compared with the performance goal of 82%. Stent delivery occurred successfully in 97.7% of cases with <50% stenosis in 98.6% of subjects. Low rates of in-hospital Q-wave myocardial infarction (0.7%), cardiac death (0.2%), and target vessel revascularization (0.7%) were reported. CONCLUSIONS: The ORBIT II coronary OAS trial met both the primary safety and efficacy endpoints by significant margins. Preparation of severely calcified plaque with the OAS not only helped facilitate stent delivery, but improved both acute and 30-day clinical outcomes compared with the outcomes of historic control subjects in this difficult-to-treat patient population. (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions [ORBIT II]; NCT01092416).


Assuntos
Aterectomia Coronária/instrumentação , Estenose Coronária/terapia , Calcificação Vascular/terapia , Idoso , Aterectomia Coronária/efeitos adversos , Estenose Coronária/diagnóstico , Estenose Coronária/mortalidade , Desenho de Equipamento , Feminino , Humanos , Masculino , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/mortalidade , Intervenção Coronária Percutânea/instrumentação , Estudos Prospectivos , Índice de Gravidade de Doença , Stents , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Calcificação Vascular/diagnóstico , Calcificação Vascular/mortalidade
15.
J Emerg Med ; 40(4): 367-73, 2011 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-18823734

RESUMO

BACKGROUND: Current guidelines define cardiac troponin I (TnI) as an indicator of necrosis when the concentration exceeds the 99% upper limit of a healthy reference population, a reference value near the assay's lowest detectable level. We assessed the utility of a modified TnI cutoff point derived from a population at low risk for coronary artery disease (CAD) and evaluated its utility in determining acute myocardial infarction (MI). METHODS: A modified TnI cutoff point was derived by the receiver operating characteristic (ROC) curve from 737 consecutive patients who underwent serial TnI measurements for exclusion of MI. Creatinine kinase isoenzyme MB (CK-MB) evolutionary change was used to define MI. The new derived cutoff point was validated using another subset of 320 patients who were evaluated for MI. RESULTS: ROC-derived TnI cutoff point (A) was 0.65 µg/L, and its performance was compared to the recommended cutoff point ([B] 0.15 µg/L). Cutoff point A had greater specificity (94.5% vs. 86.9%, p < 0.001) but slightly lower sensitivity (96.5% vs. 100%, p < 0.01). Cutoff point A provided significantly greater positive predictive value (PPV) for MI (74.1% vs. 55.5%, p < 0.0001) and fewer false-positive errors, while preserving comparable negative predictive value (NPV) (98.9% vs. 100%). CONCLUSION: A higher cutoff point derived from a reference population of patients at low risk for CAD may improve the TnI performance assay. The PPV for diagnosis of MI was significantly higher and false-positive values were fewer without affecting the NPV. The more reliable diagnosis of MI may have resulted, which, in turn, may have significant clinical and economic implications.


Assuntos
Infarto do Miocárdio/diagnóstico , Troponina I/sangue , Idoso , Biomarcadores/sangue , Reações Falso-Negativas , Reações Falso-Positivas , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/sangue , Valor Preditivo dos Testes , Curva ROC , Valores de Referência , Estudos Retrospectivos
16.
EuroIntervention ; 6(3): 313-20, 2010 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-20884408

RESUMO

AIMS: To investigate tissue characteristics of atherosclerotic plaques in coronary artery bifurcations. METHODS AND RESULTS: Using a global virtual histology registry, geometric and compositional characteristics of plaque in three segments (proximal, distal, and at the bifurcation) of coronary bifurcation sites were analysed with intravascular ultrasound radiofrequency data (RFD) analysis. A total of 256 bifurcation sites were analysed: left main (LM)-left anterior descending artery (LAD), 41; LAD-diagonal artery, 128; left circumflex artery-obtuse marginal artery, 34; and right coronary artery-acute marginal artery, 53. The plaque+media (P+M) burden was larger in the distal segments of LM-LAD bifurcation sites than in the proximal and at the bifurcation segments (46.55±12.08% vs. 40.40±11.76%, 41.15±11.01%, p<0.001). The % necrotic core (NC) and % dense calcium (DC) at the bifurcation and distal segments of LM-LAD bifurcation sites was significantly greater than in the proximal segments (6.75±5.09%, 7.36±6.01% vs. 4.89±4.78%, p<0.05, and 3.31±2.87%, 3.73±3.28% vs. 1.89±2.10%, p<0.001). In contrast, P+M burden, % NC and % DC in the proximal segments of non-LM bifurcation sites was significantly greater than at the bifurcation and distal segments (49.41±12.12% vs. 45.34±11.21%, 46.80±10.68% / 8.08±6.21% vs. 6.47±5.11%, 6.28±5.05% / 4.57±4.67% vs. 3.38±3.44%, 3.55±3.74%, all p<0.001). CONCLUSIONS: The results demonstrate that heterogeneous nature of coronary atherosclerosis at coronary bifurcations according to their segments and anatomical locations (LM-LAD vs. non-LM bifurcations). The further investigation for the clinical efficacy of the RFD analysis on bifurcation sites are warranted.


Assuntos
Doença da Artéria Coronariana/diagnóstico por imagem , Vasos Coronários/diagnóstico por imagem , Placa Aterosclerótica/diagnóstico por imagem , Ultrassonografia de Intervenção/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes
17.
Circ Cardiovasc Interv ; 2(1): 43-51, 2009 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-20031692

RESUMO

BACKGROUND: Only limited data describe relationships between stent parameters (length and diameter), adverse events after percutaneous coronary intervention, and effects of platelet glycoprotein IIb/IIIa blockade by stent parameters. METHODS AND RESULTS: In this post hoc analysis of the 1983 patients receiving a stent in the Enhanced Suppression of the Platelet Glycoprotein IIb/IIIa Receptor with Integrilin Therapy randomized percutaneous coronary intervention trial of eptifibatide versus placebo, rates of the major adverse cardiac event (MACE) end point (death, myocardial infarction, urgent target-vessel revascularization, or thrombotic bailout) at 48 hours and 1 year were correlated with stent parameters and then analyzed by randomization to eptifibatide versus placebo. In the placebo group, MACE increased with number of stents implanted, total stent length (by quartiles of <15, 15 to <18, 18 to <30, and >or=30 mm), and total stented vessel area (by quartiles of area <141, 141 to <188, 188 to <292, and >or=292 mm(2)). By stent parameters, MACE at 48 hours was reduced in the eptifibatide group at stent lengths of 18 to <30 mm (odds ratio [OR], 0.55; 95% CI, 0.32 to 0.94; P=0.030) and >or=30 mm (OR, 0.43; 95% CI, 0.25 to 0.75; P=0.003), stent diameters of >2.5 to <3.5 mm (OR, 0.56; 95% CI, 0.39 to 0.82; P=0.002), and with 2 stents implanted (OR, 0.39; 95% CI, 0.22 to 0.69; P=0.001). In the placebo group, near-linear relationships were observed between both increasing stent length and increasing stented vessel area and MACE at 48 hours and 1 year (all, P<0.001); these gradients were flattened in the eptifibatide group (P=0.005 for stent length). CONCLUSIONS: Stent parameters predict MACE after percutaneous coronary intervention. Glycoprotein IIb/IIIa blockade mitigates much of the hazard of increasing procedural complexity.


Assuntos
Angioplastia Coronária com Balão/instrumentação , Doença da Artéria Coronariana/terapia , Peptídeos/uso terapêutico , Inibidores da Agregação Plaquetária/uso terapêutico , Complexo Glicoproteico GPIIb-IIIa de Plaquetas/antagonistas & inibidores , Stents , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/mortalidade , Doença da Artéria Coronariana/tratamento farmacológico , Doença da Artéria Coronariana/mortalidade , Método Duplo-Cego , Eptifibatida , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/prevenção & controle , Razão de Chances , Peptídeos/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Desenho de Prótese , Medição de Risco , Fatores de Risco , Trombose/etiologia , Trombose/prevenção & controle , Resultado do Tratamento
18.
J Am Coll Cardiol ; 47(4): 715-8, 2006 Feb 21.
Artigo em Inglês | MEDLINE | ID: mdl-16487833

RESUMO

OBJECTIVES: In order to determine a differential benefit from treatment, we compared the long-term outcome of high-risk versus low-risk patients and evaluated survival free from death or myocardial infarction at one year. BACKGROUND: Newer anticoagulant strategies during percutaneous coronary intervention have necessitated a reanalysis of the role of intravenous GP IIb/IIIa inhibitors. The Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy trial randomized 2,064 patients undergoing nonurgent coronary stent implantation to eptifibatide or placebo. METHODS: High-risk characteristics were defined as age >75 years, diabetes, elevated cardiac markers, ST-segment elevation myocardial infarction within 7 days, or unstable angina within 48 h of randomization. Age <5 years, absence of diabetes, and any other reason for admission were considered low risk characterstics. RESULTS: There were 1,018 patients in the high-risk group (50.8% eptifibatide, 49.2% placebo) and 1,045 patients in the low-risk group (50.0% eptifibatide, 50.0% placebo). Baseline demographics were similar in both groups except for more hypertension (63% vs. 55%, respectively), peripheral vascular disease (8.2% vs. 5.2%, respectively), prior stroke (5.5% vs. 3.2%, respectively), and female gender (33% vs. 22%, respectively) in the high-risk than the low-risk group. At one year, the composite end point of death or myocardial infarction occurred in 15.89% of placebo patients and 7.99% of eptifibatide patients in the high-risk group and 9.02% of the placebo and 8.11% of eptifibatide patients in the low-risk group. CONCLUSIONS: Although eptifibatide treatment improved outcomes for all patients, preprocedural clinical characteristics can define a subgroup of patients who may derive greatest benefit from its use during coronary stent placement.


Assuntos
Angioplastia Coronária com Balão , Doença das Coronárias/terapia , Peptídeos/uso terapêutico , Inibidores da Agregação Plaquetária/uso terapêutico , Complexo Glicoproteico GPIIb-IIIa de Plaquetas/antagonistas & inibidores , Stents , Idoso , Doença das Coronárias/mortalidade , Intervalo Livre de Doença , Eptifibatida , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Taxa de Sobrevida , Resultado do Tratamento
19.
Catheter Cardiovasc Interv ; 66(2): 291-6, 2005 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-16142812

RESUMO

Acute peripheral arterial occlusion may be caused by thrombosis or embolism. The objectives of therapy are to preserve limb and life by restoration of blood flow. Thrombolytic therapy has been the mainstay, but is limited by a high risk of bleeding. Surgical treatment, often required, is invasive with higher rates of morbidity and mortality. Rheolytic thrombectomy offers a percutaneous means of thrombus removal. A 62-year-old man with chronic atrial fibrillation, idiopathic dilated cardiomyopathy, and hypothyroidism presented with sudden onset of left arm pain. His medications included warfarin, digoxin, amiodarone, and synthroid. Examination revealed a harsh 3/6 systolic nonradiating murmur. The left arm was cold and weak with absent pulses. Laboratory data showed a prothrombin time (PT) of 12 sec and an international normalized ratio of 1.4. After heparinization, angiography was performed, showing a total occlusion of the brachial artery. A rheolytic thrombectomy catheter (RTC) was introduced to remove the thrombus. The RTC run time was 90 sec. Flow was restored to the vessel, but sluggish with angiographic evidence of stenosis. Intravascular ultrasound was performed, revealing a high-grade fibromuscular stenosis. Balloon angioplasty was performed, followed by intracatheter injection of alteplase restoring normal flow. Sudden arterial occlusion is a medical emergency, which can result in limb loss. RTC's have demonstrated a reduced need for thrombolytic agents and surgical intervention, thereby decreasing complications, procedural time, and resource utilization. While most reports have focused on infra-aortic thromboses, this case highlights its utility in the arm.


Assuntos
Braço/irrigação sanguínea , Arteriopatias Oclusivas/terapia , Trombectomia/métodos , Ultrassonografia de Intervenção , Angioplastia , Arteriopatias Oclusivas/diagnóstico por imagem , Artéria Braquial/diagnóstico por imagem , Humanos , Masculino , Pessoa de Meia-Idade , Terapia Trombolítica
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