RESUMO
The field of transcatheter aortic valve replacement (TAVR) has matured significantly with the outcome and durability data now supporting use in lower-risk patients. We present a preventable complication from early in our experience (5 years ago) that illustrates the importance of heart team communication and cautious multidiscipline cross-pollination during the formative years of a program. An 87-year old female developed confusion, slurred speech and left upper extremity weakness 1 day following TAVR with inconclusive findings on carotid artery duplex and transthoracic echocardiography. Subsequent CT-scan disclosed a linear, ring-like, structure in the ascending aorta. The foreign body (FB) was radiolucent and successfully snared via tactile sensation and anatomic landmarks informed by the CT. The extricated FB was the valvuloplasty balloon guard (BG) that was inadvertently introduced into the patient via ascending aortic large sheath access. The failure mode was traced back to the first time use of a new balloon system and unrecognized BG by the surgical physician and technician components of the Heart Team who took the lead role in device insertion due to the open chest access. Subsequently, the heart team made changes to mitigate similar future complications by sharing multidiscipline responsibility for all procedural steps and ensuring the use of all new adjuvant devices are preceded by a procedural pause and team consensus regarding device preparation and use. Additionally, the manufacturer addition of a radiopaque marker or flair on the valvuloplasty BG may be warranted.
Assuntos
Estenose da Valva Aórtica/cirurgia , Valvuloplastia com Balão/efeitos adversos , Migração de Corpo Estranho/etiologia , Acidente Vascular Cerebral/etiologia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico por imagem , Valvuloplastia com Balão/instrumentação , Remoção de Dispositivo , Feminino , Migração de Corpo Estranho/diagnóstico por imagem , Migração de Corpo Estranho/terapia , Humanos , Índice de Gravidade de Doença , Acidente Vascular Cerebral/diagnóstico por imagem , Substituição da Valva Aórtica Transcateter/instrumentaçãoRESUMO
PURPOSE OF REVIEW: Most hypertension devices have been designed to interrupt or modify the sympathetic nervous system, which seems to be unbalanced in hypertension. Carotid baroreceptors play a pivotal role in maintaining adrenergic balance via a direct feedback interface and would be an exceptional target for intervention. The purpose of this review is to define the role of the baroreceptor in hypertension, to examine device-based therapies targeting the baroreflex and to explore future promises of endovascular baroreflex amplification (EBA). RECENT FINDINGS: In the last two decades, two therapeutic strategies targeting the carotid baroreceptor have evolved: baroreflex activation therapy (BAT) and EBA. Both therapies enhance baroreceptor activity, either directly by electrical stimulation or indirectly by changing the geometric shape of the carotid sinus and increasing pulsatile wall strain. By showing a significant, sympathetic inhibition-mediated effect on blood pressure, BAT has laid the foundation for baroreflex-targeting therapies for resistant hypertension. EBA is a less invasive therapy with promising first-in-man study results. Ongoing randomized sham-controlled trials are needed to better understand efficacy, durability, and long-term safety and define phenotypes that may most benefit from this treatment.
Assuntos
Barorreflexo/fisiologia , Pressão Sanguínea/fisiologia , Implante de Prótese Vascular , Terapia por Estimulação Elétrica , Hipertensão/terapia , Pressorreceptores/fisiopatologia , Implante de Prótese Vascular/instrumentação , Seio Carotídeo/fisiopatologia , Simulação por Computador , Humanos , Hipertensão/fisiopatologia , Stents , Sistema Nervoso Simpático/fisiopatologiaRESUMO
BACKGROUND: The D-dimer (DD) level combined with the pretest Wells criteria probability (WCP) score can safely exclude deep venous thrombosis (DVT). The objective of this study was to examine the correlation between DD results alongside WCP score with findings on venous duplex ultrasound (VDU). The hypothesis is that VDU remains overutilized in low-risk patients with negative DD and that higher DD levels may correlate with thrombus burden and location. METHODS: Patients who presented to a high-volume tertiary care center with lower limb swelling with or without associated pain were retrospectively examined through June and July for 4 consecutive years (2012 to 2015). After calculating WCP, patients were divided into low-, moderate-, and high-risk categories. Electronic DD results utilizing enzyme linked immunosorbent assay, WCP data, and VDU analysis data were merged and analyzed based on receiver operator characteristic curve to determine the DD cutoff point for each WCP. Abnormal DD with an average value ≥ 0.6 mg/L fibrinogen equivalent units (FEUs) was correlated to positive DVT to differentiate proximal DVT (above popliteal vein) from distal DVT (below popliteal vein). RESULTS: Data of 1,909 patients were analyzed, and 239 (12.5%) patients were excluded secondary to serial repeat visits or follow-ups, surveillance screens, and if they had a previous history of DVT. The average age was 62.1 ± 16.3 years with more women (55.7%) and the majority presented with limb pain and edema (87%). DD studies were ordered and completed in 202 patients and correlated with all positive and negative DVT patients (100% sensitivity and negative predictive value, with specificity and positive predictive value of 14.9% and 15.9%, respectively). Twenty-six of 202 patients had DD that were in the normal range 0.1-0.59 mg/L (FEU), all of which were negative for DVT (100% sensitive). Fifty one of 202 patients had DD values of 0.6-1.2 mg/L FEU, of which only 3 DVTs were recorded, and all of them were distal DVTs. In addition, 685 patients with WCP <1 and negative DD were sent for VDU. Thus, 762 patients had an unnecessary immediate VDU (Wells ≤1 and -DD) study during their initial presentation. Potential charge savings for VDU for all patients are 762 × $1,557 = $1,186,434 and DD for all patients are 762 × $182 = $138,684, with total potential savings of $1,047,750 (USD 2016). CONCLUSIONS: This study suggests that DD is still underutilized, and DD in conjunction with WCP could significantly reduce the number of unnecessary immediate VDUs. Higher value of DD (>1.2 mg/L FEU) may raise concern for proximal DVT. Concern on cost-effectiveness exists and raises the demand for a proposed algorithm to be followed.
Assuntos
Produtos de Degradação da Fibrina e do Fibrinogênio/análise , Ultrassonografia Doppler Dupla , Trombose Venosa/sangue , Trombose Venosa/diagnóstico por imagem , Idoso , Área Sob a Curva , Biomarcadores/sangue , Tomada de Decisão Clínica , Redução de Custos , Análise Custo-Benefício , Técnicas de Apoio para a Decisão , Feminino , Custos de Cuidados de Saúde , Hospitais com Alto Volume de Atendimentos , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Prognóstico , Curva ROC , Reprodutibilidade dos Testes , Estudos Retrospectivos , Fatores de Risco , Índice de Gravidade de Doença , Centros de Atenção Terciária , Ultrassonografia Doppler Dupla/economia , Procedimentos Desnecessários/economia , Trombose Venosa/economia , Trombose Venosa/terapiaRESUMO
BACKGROUND: Validation of subclavian duplex ultrasound velocity criteria (SDUS VC) to grade the severity of subclavian artery stenosis has not been established or systematically studied. Currently, there is a paucity of published literature and lack of practitioner consensus for how subclavian duplex velocity findings should be interpreted in patients with subclavian artery stenosis. OBJECTIVE: The objective of the present study was to validate SDUS measurements using subclavian conventional or computed tomography angiogram (subclavian angiogram [SA])-derived measurements. Secondary objectives included measuring the correlation between SDUS peak systolic velocities and SA measurements, and to determine the optimal cutoff value for predicting significant stenosis (>70%). METHODS: This is a retrospective review of all patients with suspected subclavian artery stenosis and a convenience sample of carotid artery patients who underwent SDUS and SA from May 1999 to July 2013. SA reference vessel and intralesion minimal lumen diameters were measured and compared with SDUS velocities obtained within 3 months of the imaging study. Percent stenosis was calculated using the North American Symptomatic Carotid Endarterectomy Trial method for detecting stenosis in a sufficiently large cohort. Receiver operating characteristic curves was generated for SDUS VC to predict >70% stenosis. Velocity cutoff points were determined with equal weighting of sensitivity and specificity. RESULTS: We examined 268 arteries for 177 patients. The majority of the arteries were for female patients (52.5%) with a mean age of 66.7 ± 11.1 years. Twenty-three arteries had retrograde vertebral artery flow and excluded from further analysis. For the remaining 245 arteries, the average peak systolic velocity was 212.6 ± 110.7 cm/s, with a range of 45-626 cm/s. Average stenosis was 25.8% ± 28.2%, with a range of 0% to 100%. Following receiver operating characteristic analysis, we found a cutoff value of >240 cm/s to be most predictive of >70%. Area under the curve was 0.94 with 95% confidence intervals of 0.91 to 0.97. The sensitivity and specificity for predicting >70% stenosis was 90.9 and 82.5%, respectively. CONCLUSIONS: In patients with known or suspected disease involving the great vessels, a subclavian artery flow velocity exceeding 240 cm/s seems to be predictive of significant subclavian stenosis. Thus, we propose new SDUS VC, for predicting subclavian artery stenosis. However, because of the use of a convenience sample, it is possible that the current proposed cutoff point might need to be adjusted for other populations.
Assuntos
Síndrome do Roubo Subclávio/diagnóstico por imagem , Ultrassonografia Doppler Dupla , Idoso , Área Sob a Curva , Velocidade do Fluxo Sanguíneo , Angiografia por Tomografia Computadorizada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Prognóstico , Curva ROC , Fluxo Sanguíneo Regional , Reprodutibilidade dos Testes , Estudos Retrospectivos , Índice de Gravidade de Doença , Síndrome do Roubo Subclávio/fisiopatologiaRESUMO
Since 2005, the American Board of Vascular Medicine (ABVM) endovascular examination has been used to certify vascular practitioners. Annual rigorous review has confirmed it is psychometrically valid and reliable. However, the evidence basis underlying the examination items has not been studied systematically. The aim of this study was to adjudicate class of recommendation (COR) and level of evidence (LOE) for the 2015 ABVM endovascular examination and establish an additional feedback mechanism for examination improvement based on contemporary evidence-based guidelines. We performed a pooled consensus process to classify each of the 110 items in the 2015 ABVM endovascular examination by COR and LOE as detailed in the current guideline statements. We added additional categories for items that were not eligible for assignment using traditional current evidence-based metrics: 'COR X', cannot be determined, not applicable, or simple recognition; and 'LOE X', cannot be determined or not applicable. COR classifications were assigned in the following proportion: Class I=15%, Class II=40%, Class III=3%, COR X=42%. LOE classifications were assigned in the following proportion: Level A=12%, Level B=34%, Level C=32%, LOE X=22%. Our analysis showed that nearly half of the 2015 ABVM endovascular examination items were supported by strong scientific evidence or fact-based knowledge. COR and LOE analysis yielded notably different results. Use of alternate classification schema may be powerful tools for improving certification exams in healthcare.
Assuntos
Cardiologia/normas , Certificação/normas , Competência Clínica/normas , Educação de Pós-Graduação em Medicina/normas , Avaliação Educacional/normas , Procedimentos Endovasculares/normas , Medicina Baseada em Evidências/normas , Conselhos de Especialidade Profissional/normas , Doenças Vasculares/terapia , Cardiologia/educação , Currículo , Escolaridade , Procedimentos Endovasculares/educação , Feminino , Guias como Assunto , Humanos , Masculino , Pessoa de Meia-Idade , Psicometria , Estados Unidos , Doenças Vasculares/diagnóstico , Doenças Vasculares/fisiopatologiaRESUMO
BACKGROUND: Several studies have demonstrated better outcomes for carotid endarterectomy with high-volume hospitals and providers. However, only a few studies have reported on the impact of operator specialty/volume on the perioperative outcome of carotid artery stenting (CAS). This study will analyze the correlation of CAS outcomes and provider specialty and volume. METHODS: Prospectively collected data of CAS procedures done at our institution during a 10-year period were analyzed. Major adverse events (MAEs; 30-day stroke, myocardial infarction, and death) were compared according to provider specialty (vascular surgeons [VSs], interventional cardiologists [ICs], interventional radiologists [IRs], interventional vascular medicine [IVM]), and volume (≥5 CAS/year vs. <5 CAS/year). RESULTS: Four hundred fourteen CAS procedures (44% for symptomatic indications) were analyzed. Demographics/clinical characteristics were somewhat similar between specialties. MAE rates were not significantly different between various specialties: 3.1% for IC, 6.3% for VS, 7.1% for IR, 6.7% for IVM (P = 0.3121; 6.3% for VS and 3.8% for others combined, P = 0.2469). When physicians with <5 CAS/year were excluded: the MAE rates were 3.1% for IC, 4.7% for VS, and 6.7% for IVM (P = 0.5633). When VS alone were compared with others, and physicians with <5 CAS/year were excluded, the MAE rates were 4.7% for VS vs. 3.6% for non-VS (P = 0.5958). The MAE rates for low-volume providers, regardless of their specialty, were 9.5% vs. 4% for high-volume providers (P = 0.1002). Logistic regression analysis showed that the odds ratio of MAE was 0.4 (0.15-1.1, P = 0.0674) for high-volume providers, while the odds ratio for VS was 1.3 (0.45-3.954, P = 0.5969). CONCLUSIONS: Perioperative MAE rates for CAS were similar between various providers, regardless of specialties, particularly for vascular surgeons with similar volume to nonvascular surgeons. Low-volume providers had higher MAE rates.
Assuntos
Cardiologistas , Doenças das Artérias Carótidas/terapia , Procedimentos Endovasculares/instrumentação , Avaliação de Processos em Cuidados de Saúde , Radiologistas , Especialização , Stents , Cirurgiões , Carga de Trabalho , Adulto , Idoso , Idoso de 80 Anos ou mais , Doenças das Artérias Carótidas/complicações , Doenças das Artérias Carótidas/diagnóstico por imagem , Doenças das Artérias Carótidas/mortalidade , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Razão de Chances , Radiografia Intervencionista , Estudos Retrospectivos , Fatores de Risco , Acidente Vascular Cerebral/etiologia , Fatores de Tempo , Resultado do Tratamento , West VirginiaRESUMO
Renal artery stenosis may play a significant role in the pathogenesis of secondary hypertension, renal dysfunction, and flash pulmonary edema. Currently correction of renal arterial inflow stenosis is reserved for resistant hypertension patients who have failed maximal medical therapy, have worsening renal function and/or unexplained proximal congestive failure. With the recent advances in minimally invasive percutaneous stent placement techniques, open surgical revascularization has been largely replaced by renal artery stenting. The potential benefit of revascularization seemed intuitive; however, the initial enthusiasm and rise in the number of percutaneous interventions have been tempered by many subsequent negative randomized clinical trials that failed to prove the proposed benefits of the percutaneous intervention. The negative randomized trial results have fallen under scrutiny due to trial design concerns and inconsistent outcomes of these studies compared to pivotal trials undertaken under US Food and Drug Administration scrutiny. Treatment of atherosclerotic renal artery occlusive disease has become one of the most debatable topics in the field of vascular disease. The results from recent randomized clinical trials of renal artery stenting have basically limited the utilization of the procedure in many centers, but not every clinical scenario was covered in those trials. There are potential areas for improvement focusing mainly on procedural details and patient selection with respect to catheter based treatment of atherosclerotic renal artery stenosis. We believe, limiting patient selection, enrollment criteria and outcomes measured functioned to reduce the benefit of renal artery stenosis stenting by not enrolling patients likely to benefit. Future studies incorporating potential procedural improvements and that include patients more likely to benefit from renal stenting than were included in ASTRAL and CORAL are needed to more carefully examine specific patient subgroups so that "the baby is not thrown out with the bath water." We also discuss several other concerns related to renal artery stenting which include diagnostic, procedure, indication, and reimbursement issues.
Assuntos
Angioplastia/instrumentação , Hipertensão Renovascular/terapia , Obstrução da Artéria Renal/terapia , Artéria Renal/fisiopatologia , Circulação Renal , Stents , Angioplastia/efeitos adversos , Humanos , Hipertensão Renovascular/diagnóstico , Hipertensão Renovascular/fisiopatologia , Seleção de Pacientes , Obstrução da Artéria Renal/diagnóstico , Obstrução da Artéria Renal/fisiopatologia , Fatores de Risco , Resultado do TratamentoRESUMO
When performed by experienced clinicians, renal nerve denervation (RND) can be done with very low risk of complication and/or acute renal injury Renal function seems to remain unchanged in this small series over 3 years More studies are needed to establish the role of renal biomarkers in assessment of acute renal injury in this setting and larger series of RND in azotemic patients should be done before the procedure indications can be expanded.
Assuntos
Hipertensão , Resultado do Tratamento , Injúria Renal Aguda , Biomarcadores , Humanos , Rim/inervação , SimpatectomiaRESUMO
PURPOSE: To report the long-term outcomes of patients who underwent carotid artery stenting (CAS) for de novo carotid stenosis vs patients treated for restenosis after carotid endarterectomy (CEA). METHODS: A retrospective review was conducted of all 385 patients (mean age 68.6±9.6 years; 231 men) who underwent 435 CAS procedures at a large tertiary care center between January 1999 and December 2013. For analysis, patients were stratified based on their lesion type [de novo (dn) vs post-CEA restenosis (res)] and subclassified by symptoms status [symptomatic (Sx) or asymptomatic (Asx)], creating 4 groups: (1) CAS-dn Asx, (2) CAS-dn Sx, (3) CAS-res Asx, and (4) CAS-res Sx. For the CAS-res group, the mean elapsed time from CEA to CAS was 72.4±63.6 months. Outcomes included target vessel reintervention (TVR) and in-stent restenosis (ISR), the latter defined by a carotid duplex ultrasound velocity >275 cm/s. RESULTS: The main indication for initial carotid angiography with possible revascularization was severe carotid stenosis (≥70%-99% on duplex) in both CAS-dn and CAS-res groups (83.6% vs 83.7%, p=0.999). There were no significant differences in the percentage of patients with postintervention residual stenosis (<30%; 100% each arm) or complications between CAS-res vs CAS-dn: in-hospital stroke (1.4% vs 1.8%, respectively), myocardial infarction (0.9% vs 0%), or death (0.9% vs 0%). Mean follow-up was 62.4±45.6 months (median 53.5, range 1-180). Average clinical/TVR follow-up was greater for the CAS-res group (71.9±48.6 months) compared with 53.3±40.5 months for the CAS-dn group (p<0.001). Across the 4 study groups, there were no differences in freedom from ISR (p=0.174) or TVR (p=0.856). Multivariate analysis found peripheral vascular disease (PVD) as the sole ISR independent predictor [hazard ratio (HR) 1.92, 95% confidence interval (CI) 1.03 to 3.62, p=0.041], while significant predictors for TVR were age <65 years at the time of the procedure (HR 2.55, 95% CI 1.05 to 6.18, p=0.039) and PVD (HR 2.46, 95% CI 1.03 to 5.87, p=0.043). CONCLUSION: The current study suggests that CAS is a feasible and durable therapeutic option for recurrent restenosis after CEA. Long-term outcomes were similar for patients treated for de novo lesions or post-CEA restenosis. Age and PVD appear to influence long-term CAS durability.
Assuntos
Angioplastia/instrumentação , Doenças das Artérias Carótidas/terapia , Endarterectomia das Carótidas/efeitos adversos , Stents , Fatores Etários , Idoso , Angioplastia/efeitos adversos , Doenças das Artérias Carótidas/diagnóstico , Doenças das Artérias Carótidas/epidemiologia , Doenças das Artérias Carótidas/cirurgia , Comorbidade , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Doença Arterial Periférica/epidemiologia , Modelos de Riscos Proporcionais , Recidiva , Estudos Retrospectivos , Fatores de Risco , Índice de Gravidade de Doença , Centros de Atenção Terciária , Fatores de Tempo , Resultado do Tratamento , Ultrassonografia Doppler Dupla , West VirginiaRESUMO
Carotid artery stenting (CAS) has evolved into a viable alternative to carotid endarterectomy. Although CAS outcomes have improved during the last decade, the associated stroke rate remains higher when compared with carotid endarterectomy. Therefore, the pivotal role of embolic protection devices (EPDs) in minimizing stroke risk cannot be underestimated as a vital component of CAS. As technology advances, EPDs continue to be refined, and each device currently on the market has its own advantages and disadvantages. This review provides an overview of the current status of EPDs and highlights the unique features of each device, followed by suggestions for application in specific clinical scenarios.
Assuntos
Estenose das Carótidas/cirurgia , Dispositivos de Proteção Embólica , Stents/efeitos adversos , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Humanos , Desenho de PróteseRESUMO
OBJECTIVE: Contrary to coronary artery literature, the effect of preprocedural clopidogrel on renal artery restenosis (RAR) has not been characterized. This study was designed to evaluate the effect of preprocedural clopidogrel on target vessel revascularization (TVR), reintervention, and restenosis for patients who underwent recurrent renal artery angioplasty. METHODS: A retrospective analysis of patients treated for RAR in a single tertiary center from January 1999 to December 2009 was conducted. Patients were divided into preadmission use of (1) clopidogrel or (2) aspirin only (acetylsalicylic acid [ASA]) for the initial procedure. TVR was defined as occurrence of a tertiary procedure for symptomatic RAR. Rate of freedom from event (ie, tertiary restenosis and TVR) was analyzed using Kaplan-Meier method. RESULTS: Eighty-eight interventions were performed on 77 patients with RAR; 66% were females with average (mean ± SEM) age and body mass index of 68.8 ± 1.1 and 28.6 ± 0.8, respectively. Comorbidities included 96% chronic hypertension, 33% diabetes, 76% hyperlipidemia, 20% renal insufficiency, 39% tobacco use, 58% coronary artery disease, and 51% peripheral vascular disease. Clopidogrel use increased significantly during the index procedure from admission 35.2% to discharge 97.7% (P < .001, McNemar test). There was a trend toward risk reduction of a tertiary intervention (23%) for patients admitted on clopidogrel compared with ASA (P = .052). Likewise, there was a trend (P = .051) toward increased freedom from a tertiary intervention, with cumulative freedom at 8 years 93.5% for clopidogrel vs 61% for ASA. No differences were found for restenosis. CONCLUSIONS: The use of preprocedural clopidogrel was associated with a possible risk reduction of TVR reintervention, but this finding needs to be validated in randomized clinical trial.
Assuntos
Angioplastia com Balão , Inibidores da Agregação Plaquetária/uso terapêutico , Obstrução da Artéria Renal/terapia , Ticlopidina/análogos & derivados , Idoso , Aspirina/uso terapêutico , Clopidogrel , Comorbidade , Feminino , Humanos , Tábuas de Vida , Masculino , Obstrução da Artéria Renal/epidemiologia , Retratamento , Prevenção Secundária , Stents , Ticlopidina/uso terapêuticoRESUMO
OBJECTIVES: The purpose of this study was to evaluate short and long-term outcomes of percutaneous transluminal intervention in patients with symptomatic renal artery stenosis due to fibromuscular dysplasia (RAFMD) and/or the combination of RAFMD with aorto-ostial atherosclerotic disease. METHODS: A retrospective analysis of all patients with renal artery RAFMD who underwent transcatheter therapy between January 1999 and December 2009 was performed. Blood pressure (BP) measurement, number of BP medications, and hypertension defined by a systolic BP >140 ± diastolic BP >90 were recorded. Renal function was defined by estimated glomerular filtration rate (eGFR). Restenosis was defined by stenosis >60% and was determined by renal artery duplex and/or angiography. Freedom from event (restenosis, renal failure, or recurrent hypertension) was performed using life table analysis. RESULTS: Forty-three procedures were performed on 35 patients with RAFMD. Thirty-two patients (91%) were women, with mean age of 61.9 years old. Technical success was 100% with adjunctive stent placement required in the FMD segment for dissection in 1 patient (2.3%) and in the non-FMD aorto-ostial atherosclerotic lesion in 4 patients (9.3%). Short-term outcomes: the majority (69%) had an immediate clinical benefit for hypertension, 6% were cured without BP medications, and 63% improved with less than or equal to preoperative BP medications. Postintervention, 17% remained at moderately reduced renal function (<60), whereas the percent above >60 mL/minute eGFR increased significantly (from 51% to 69%; P = .002). For the entire cohort, renal function (mean eGFR) significantly increased from 71.9 mL/minute + 5.8 to 80.8 mL/minute + 5.2 (P = .007). Long-term outcomes: freedom from recurrent or worsening hypertension (>140 systolic blood pressure [SBP] and >90 diastolic blood pressure [DBP]) was (93%, 75%, and 41%) and freedom from reduced renal function (eGFR <30 mL/minute) was (100%, 95%, and 64%) at 1, 5, and 8 years, respectively. Patients with reduced baseline renal function (<60 mL/minute) and combined atherosclerotic disease were more likely to experience long-term reduced renal function (eGFR <30 mL/minute; P = .003). Primary and assisted primary patency was (95%, 71%, and 50%) and (100%, 100%, and 100%) at 1, 5, and 9 years, respectively. CONCLUSION: Renal angioplasty is a safe and durable modality for treating RAFMD with favorable short and long-term clinical outcomes. Patients with combined atherosclerotic disease and FMD were older and were more likely to have declining renal function over time. Early intervention may be imperative to achieve possible cure of hypertension.
Assuntos
Angioplastia com Balão/instrumentação , Aterosclerose/terapia , Pressão Sanguínea , Displasia Fibromuscular/terapia , Hipertensão Renovascular/terapia , Obstrução da Artéria Renal/terapia , Artéria Renal , Stents , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/mortalidade , Anti-Hipertensivos/uso terapêutico , Aterosclerose/complicações , Aterosclerose/diagnóstico , Aterosclerose/mortalidade , Aterosclerose/fisiopatologia , Pressão Sanguínea/efeitos dos fármacos , Distribuição de Qui-Quadrado , Feminino , Displasia Fibromuscular/complicações , Displasia Fibromuscular/diagnóstico , Displasia Fibromuscular/mortalidade , Displasia Fibromuscular/fisiopatologia , Taxa de Filtração Glomerular , Humanos , Hipertensão Renovascular/diagnóstico , Hipertensão Renovascular/etiologia , Hipertensão Renovascular/mortalidade , Hipertensão Renovascular/fisiopatologia , Estimativa de Kaplan-Meier , Rim/irrigação sanguínea , Rim/fisiopatologia , Tábuas de Vida , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Radiografia , Recidiva , Artéria Renal/diagnóstico por imagem , Artéria Renal/fisiopatologia , Obstrução da Artéria Renal/diagnóstico , Obstrução da Artéria Renal/etiologia , Obstrução da Artéria Renal/mortalidade , Obstrução da Artéria Renal/fisiopatologia , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Ultrassonografia Doppler Dupla , Ultrassonografia de Intervenção , West VirginiaRESUMO
OBJECTIVES: The aim of this study was to evaluate the long-term (3-year) safety and effectiveness of endovascular baroreflex amplification (EVBA) from both the European and American CALM-FIM cohorts. BACKGROUND: The CALM-FIM study demonstrated that EVBA in patients with resistant hypertension significantly lowered blood pressure (BP) with an acceptable safety profile during 6-month follow-up. METHODS: The CALM-FIM studies were prospective, nonrandomized, first-in-human studies that enrolled patients with resistant hypertension (office systolic BP ≥160 mm Hg and mean 24-hour ambulatory BP ≥130/80 mm Hg despite a stable regimen of ≥3 antihypertensive medications, including a diuretic agent). The incidence of (serious) adverse events and changes in BP, heart rate, and prescribed antihypertensive medication up to 3 years after implantation were determined. RESULTS: The Mobius device was implanted in 47 patients (30 in Europe, 17 in the United States; mean age 54 years, 23 women). Five serious adverse events (hypotension, n = 2; hypertension, n = 1; vascular access complications, n = 2) and 2 transient ischemic attacks occurred within 30 days postprocedure. Two strokes and 1 transient ischemic attack occurred more than 2 years postimplantation. Mean office BP at baseline was 181 ± 17/107 ± 16 mm Hg and decreased by 25/12 mm Hg (95% CI: 17-33/8-17 mm Hg) at 6 months and 30/12 mm Hg (95% CI: 21-38/8-17 mm Hg) at 3 years. Mean 24-hour ambulatory BP at baseline was 166 ± 16/98 ± 15 mm Hg and decreased by 20/11 mm Hg (95% CI: 14-25/8-15 mm Hg) at 6 months. CONCLUSIONS: EVBA with the MobiusHD was effective in reducing BP at 3-year follow-up and appears to have an acceptable safety profile in patients with uncomplicated implantation, although data from randomized sham-controlled trials are needed to further evaluate the risk-benefit profile. (Controlling and Lowering Blood Pressure With the MobiusHD™ [CALM-FIM_EUR], NCT01911897; Controlling and Lowering Blood Pressure With the MobiusHD™ [CALM-FIM_US], NCT01831895).
Assuntos
Barorreflexo , Hipertensão , Anti-Hipertensivos/efeitos adversos , Barorreflexo/fisiologia , Pressão Sanguínea , Monitorização Ambulatorial da Pressão Arterial , Feminino , Humanos , Hipertensão/diagnóstico , Hipertensão/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Atherosclerotic renal artery stenosis (RAS) is the most common cause of secondary hypertension. Renal stenting has become the treatment of choice for RAS in most centers. Primary patency of RAS is well defined, but limited data are available on outcomes of secondary interventions for treatment of in-stent restenosis. METHODS: This was a retrospective analysis of a 10-year experience with renal artery stenting in patients presenting with recurrent symptomatic stenosis. End points included freedom from tertiary procedures, change in baseline renal function by ≥20% measured by estimated glomerular filtration rate (eGFR), patency confirmed by duplex imaging, long-term hypertension response, freedom from hemodialysis, and survival. RESULTS: We reviewed 948 patients with 1150 treated renal arteries. Of these, 107 patients (122 renal stents) returned with symptomatic in-stent restenosis and required reintervention (target vessel revascularization [TVR] rate, 10.6%): 97% had recurrent or worsening hypertension, and 67% had worsening renal function. There were 69 women (64%) and 38 men (35%) with an average age of 68.9 years. Mean follow-up was 35.5 months (range, 1.0-104.7 months) for patency and 37.7 months (range, 0.03-100.9 months) for renal function (creatinine). Secondary interventions included 27 percutaneous transluminal angioplasties (PTAs), 10 PTAs with cutting balloon, 77 repeat renal artery stenting, and 8 placements of drug-eluting stents (DES). Twenty-five of the 122 arteries (20%) required tertiary interventions in 23 patients, a significantly higher TVR rate vs de novo interventions (11%; P = .003). Freedom from tertiary interventions at 60 months was similar among treatment groups undergoing PTA (66%), cutting balloon (100%), stent (80%), and DES (75%; P = .348). Seventeen (16%) had an increase of >20%, 50 (47%) had a decrease of >20%, and 30 (28%) had no change in renal function. Ultimately 25 (23%) remained or progressed to renal failure (eGFR < 30%), and 8 required hemodialysis. The survival rate was 73% at 5 years. Mean follow-up for long-term hypertension response was 3.2 years, with 56% improved, 28% with no improvement or deterioration, 16% without long-term data available, and no patients cured. CONCLUSIONS: Secondary interventions for renal in-stent restenosis had higher TVR vs de novo renal stents in this large series (21% vs 11%; P = .003). Definitive recommendations on the best secondary treatment strategy cannot be made because a medical treatment control group was not available for comparison.
Assuntos
Angioplastia com Balão/instrumentação , Rim/irrigação sanguínea , Obstrução da Artéria Renal/terapia , Artéria Renal , Stents , Idoso , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/mortalidade , Anti-Hipertensivos/uso terapêutico , Distribuição de Qui-Quadrado , Stents Farmacológicos , Feminino , Taxa de Filtração Glomerular , Humanos , Hipertensão Renovascular/etiologia , Hipertensão Renovascular/terapia , Estimativa de Kaplan-Meier , Rim/fisiopatologia , Masculino , Recidiva , Artéria Renal/fisiopatologia , Obstrução da Artéria Renal/complicações , Obstrução da Artéria Renal/mortalidade , Obstrução da Artéria Renal/fisiopatologia , Diálise Renal , Insuficiência Renal/etiologia , Insuficiência Renal/terapia , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular , West VirginiaRESUMO
INTRODUCTION: West Virginia has the highest incidence of obesity, smoking, and diabetes within the United States, placing its population at higher risk of stroke. In addition to these endemic risk factors, Appalachia faces various socioeconomic and health care access challenges that could negatively impact stroke incidence and outcomes. At present, there are limited data regarding geographic variables on stroke outcomes in rural Appalachia. We set out to quantify Appalachian geographic patterns of stroke incidence and outcomes. METHODS: This is a retrospective analysis of all patients hospitalized with a diagnosis of stroke in West Virginia's largest tertiary hospital. During the study (2000-2018), 14,488 patients were analyzed, with an emphasis on those who died from stroke (n = 1022). We first used institutional ICD-9/10 data alongside demographics information and chart reviews to evaluate disease patterns while also exploring emerging hot spot pattern changes over time; we then exploited an emerging time series analysis using temporal trends to assess differing instances of stroke occurrence regionally with hot spots defined as higher than expected incidences of stroke and stroke death. RESULTS: Data analysis revealed several hot spots of increasing stroke and mortality rates, many of which achieved statistically significant variance compared to expected norms (P = 0.001). Moreover, this study revealed high-risk zones in rural West Virginia wherein the incidence and mortality rates of stroke are suggestively higher and less resistance to economic change than urban centers. CONCLUSIONS: Stroke incidence and mortality were found to be higher than expected in many areas of rural West Virginia. The higher stroke risk populations correlate with area that may be impacted by socioeconomic factors and limited access to primary care. These high-risk areas may therefore benefit from investments in infrastructure, patient education, and unrestricted primary care.
RESUMO
PURPOSE: Our objective was to determine significant predictors of spinal cord ischemia (SCI) following Thoracic Endovascular Aortic Repair (TEVAR) and to further develop a simple and clinically orientated risk score model. METHODS: A retrospective review of data from the Society of Vascular Surgery/Vascular Quality Initiative national data set was performed for all patients undergoing TEVAR from January, 2014 to June 2018. Preoperative demographics, procedure-related variables, and clinical details related to SCI were examined. A SCI risk score was developed utilizing a multivariable logistic regression model. RESULTS: For the 7889 patients in the final analysis who underwent TEVAR during the study period, the mean age was 67.6 ± 13.9, range 18 to 90 years, and the majority was male (65%). Postoperative outcomes included stroke (3.0%), myocardial infarction (2.9%), inhospital mortality (5.4%), transient SCI (1.5%), and permanent SCI (2.1%). Nearly half of the overall cases were performed in high volume centers. Predictors of increased risk for SCI included age by decade (odds ratio [OR]: 1.2), celiac coverage (OR: 1.5), current smoker (OR: 1.6), dialysis (OR: 1.9), 3 or more aortic implanted devices (OR: 1.7), emergent or urgent surgery (OR: 1.5), adjunct aorta-related procedure (OR: 2.5), adjunct not related (OR: 2.6), total estimated length of aortic device (19-31 cm, OR: 1.9 and ≥32 cm, OR: 3.0), ASA class 4 or 5 (OR: 1.6), and procedure time ≥154 minutes (OR: 1.8). Two predictors decreased the risk of SCI, cases from high-volume centers (OR: 0.6) and eGFR ≥ 60 (OR: 0.6). To evaluate the risk score model, probabilities of SCI from the original regression, raw score, and raw score categories resulted in area under the curve statistics of 0.792, 0.786, and 0.738, respectively. CONCLUSIONS: Spinal cord ischemia remains one of the most feared complications of TEVAR. Incidence of SCI in this large series of patients with TEVAR was 3.6% with nearly 60% being permanent. The proposed model provides an assessment tool to guide clinical decisions, patient consent process, risk-assessment, and procedural strategy.
Assuntos
Aorta Torácica/cirurgia , Aneurisma da Aorta Torácica/cirurgia , Implante de Prótese Vascular/efeitos adversos , Técnicas de Apoio para a Decisão , Procedimentos Endovasculares/efeitos adversos , Isquemia do Cordão Espinal/etiologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Aorta Torácica/diagnóstico por imagem , Aorta Torácica/fisiopatologia , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/fisiopatologia , Tomada de Decisão Clínica , Bases de Dados Factuais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Seleção de Pacientes , Valor Preditivo dos Testes , Sistema de Registros , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Isquemia do Cordão Espinal/diagnóstico , Isquemia do Cordão Espinal/fisiopatologia , Resultado do Tratamento , Estados Unidos , Adulto JovemRESUMO
INTRODUCTION: Early promising results of renal nerve denervation awakened interest in developing medical device alternatives for patients with resistant hypertension. The subsequent sham-controlled renal nerve denervation randomized trials were disappointing leading researchers and innovators to explore alternative device and trial designs to address this significant unmet need. We describe the innovation process leading to the first endovascular carotid baroreflex amplification device currently undergoing clinical trials in the United States and Europe. AREAS COVERED: We provide a brief overview of carotid baroreceptor physiology and then couple this knowledge with the fundamental principles of strain pattern changes that led to the proposed innovation. The mechanism of blood pressure reduction via enhancing innate physiologic carotid sinus baroreceptor signaling through changes in pulsatile focal carotid bulb strain is described alongside preclinical testing and early clinical results. EXPERT OPINION: The collective data to date suggest endovascular carotid baroreflex amplification may be an innovative alternative for resistant hypertension patients. However, well-controlled studies will be needed to assess efficacy, safety, durability, and risk: benefit of this permanent intravascular carotid implant. SUBJECT CODES: high blood pressure, hypertension, treatment, physiology.
Assuntos
Barorreflexo/fisiologia , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Hipertensão/fisiopatologia , Hipertensão/terapia , Animais , Seio Carotídeo/fisiopatologia , Ensaios Clínicos como Assunto , Humanos , Resultado do TratamentoRESUMO
OBJECTIVES: To confirm whether a relationship exists between male sex and coronavirus disease 2019 (COVID-19) mortality and whether this relationship is age dependent. PATIENTS AND METHODS: We queried the COVID-19 Research Network, a multinational database using the TriNetX network, to identify patients with confirmed COVID-19 infection. The main end point of the study was all-cause mortality. RESULTS: A total of 14,712 patients were included, of whom 6387 (43%) were men. Men were older (mean age, 55.0±17.7 years vs 51.1±17.9 years; P<.001) and had a higher prevalence of hypertension, diabetes, coronary disease, obstructive pulmonary disease, nicotine dependence, and heart failure but a lower prevalence of obesity. Before propensity score matching (PSM), all-cause mortality rate was 8.8% in men and 4.3% in women (odds ratio, 2.15; 95% CI, 1.87 to 2.46; P<.001) at a median follow-up duration of 34 and 32 days, respectively. In the Kaplan-Meier survival analysis, the cumulative probability of survival was significantly lower in men than in women (73% vs 86%; log-rank, P<.001). After PSM, all-cause mortality remained significantly higher in men than in women (8.13% vs 4.60%; odds ratio, 1.81; 95% CI, 1.55 to 2.11; P<.001). In the Kaplan-Meier survival analysis, the cumulative probability of survival remained significantly lower in men than in women (74% vs 86%; log-rank, P<.001). The cumulative probability of survival remained significantly lower in propensity score-matched men than in women after excluding patients younger than 50 years and those who were taking angiotensin-converting enzyme inhibitor or angiotensin receptor blocker medications on admission. CONCLUSION: Among patients with COVID-19 infection, men had a significantly higher mortality than did women, and this difference was not completely explained by the higher prevalence of comorbidities in men.