RESUMEN
BACKGROUND: The randomized, sham-controlled RADIANCE-HTN (A Study of the Recor Medical Paradise System in Clinical Hypertension) SOLO, RADIANCE-HTN TRIO, and RADIANCE II (A Study of the Recor Medical Paradise System in Stage II Hypertension) trials independently met their primary end point of a greater reduction in daytime ambulatory systolic blood pressure (SBP) 2 months after ultrasound renal denervation (uRDN) in patients with hypertension. To characterize the longer-term effectiveness and safety of uRDN versus sham at 6 months, after the blinded addition of antihypertensive treatments (AHTs), we pooled individual patient data across these 3 similarly designed trials. METHODS: Patients with mild to moderate hypertension who were not on AHT or with hypertension resistant to a standardized combination triple AHT were randomized to uRDN (n=293) versus sham (n=213); they were to remain off of added AHT throughout 2 months of follow-up unless specified blood pressure (BP) criteria were exceeded. In each trial, if monthly home BP was ≥135/85 mm Hg from 2 to 5 months, standardized AHT was sequentially added to target home BP <135/85 mm Hg under blinding to initial treatment assignment. Six-month outcomes included baseline- and AHT-adjusted change in daytime ambulatory, home, and office SBP; change in AHT; and safety. Linear mixed regression models using all BP measurements and change in AHT from baseline through 6 months were used. RESULTS: Patients (70% men) were 54.1±9.3 years of age with a baseline daytime ambulatory/home/office SBP of 150.5±9.8/151.0±12.4/155.5±14.4 mm Hg, respectively. From 2 to 6 months, BP decreased in both groups with AHT titration, but fewer uRDN patients were prescribed AHT (P=0.004), and fewer additional AHT were prescribed to uRDN patients versus sham patients (P=0.001). Whereas the unadjusted between-group difference in daytime ambulatory SBP was similar at 6 months, the baseline and medication-adjusted between-group difference at 6 months was -3.0 mm Hg (95% CI, -5.7, -0.2; P=0.033), in favor of uRDN+AHT. For home and office SBP, the adjusted between-group differences in favor of uRDN+AHT over 6 months were -5.4 mm Hg (-6.8, -4.0; P<0.001) and -5.2 mm Hg (-7.1, -3.3; P<0.001), respectively. There was no heterogeneity between trials. Safety outcomes were few and did not differ between groups. CONCLUSIONS: This individual patient-data analysis of 506 patients included in the RADIANCE trials demonstrates the maintenance of BP-lowering efficacy of uRDN versus sham at 6 months, with fewer added AHTs. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT02649426 and NCT03614260.
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Hipertensión , Arteria Renal , Femenino , Humanos , Masculino , Antihipertensivos/uso terapéutico , Presión Sanguínea , Monitoreo Ambulatorio de la Presión Arterial , Desnervación/efectos adversos , Desnervación/métodos , Hipertensión/diagnóstico , Hipertensión/tratamiento farmacológico , Riñón , Arteria Renal/diagnóstico por imagen , Simpatectomía/métodos , Resultado del Tratamiento , Persona de Mediana EdadRESUMEN
Importance: Two initial sham-controlled trials demonstrated that ultrasound renal denervation decreases blood pressure (BP) in patients with mild to moderate hypertension and hypertension that is resistant to treatment. Objective: To study the efficacy and safety of ultrasound renal denervation without the confounding influence of antihypertensive medications in patients with hypertension. Design, Setting, and Participants: Sham-controlled, randomized clinical trial with patients and outcome assessors blinded to treatment assignment that was conducted between January 14, 2019, and March 25, 2022, at 37 centers in the US and 24 centers in Europe, with randomization stratified by center. Patients aged 18 years to 75 years with hypertension (seated office systolic BP [SBP] ≥140 mm Hg and diastolic BP [DBP] ≥90 mm Hg despite taking up to 2 antihypertensive medications) were eligible if they had an ambulatory SBP/DBP of 135/85 mm Hg or greater and an SBP/DBP less than 170/105 mm Hg after a 4-week washout of their medications. Patients with an estimated glomerular filtration rate of 40 mL/min/1.73 m2 or greater and with suitable renal artery anatomy were randomized 2:1 to undergo ultrasound renal denervation or a sham procedure. Patients were to abstain from antihypertensive medications until the 2-month follow-up unless prespecified BP criteria were exceeded and were associated with clinical symptoms. Interventions: Ultrasound renal denervation vs a sham procedure. Main Outcomes and Measures: The primary efficacy outcome was the mean change in daytime ambulatory SBP at 2 months. The primary safety composite outcome of major adverse events included death, kidney failure, and major embolic, vascular, cardiovascular, cerebrovascular, and hypertensive events at 30 days and renal artery stenosis greater than 70% detected at 6 months. The secondary outcomes included mean change in 24-hour ambulatory SBP, home SBP, office SBP, and all DBP parameters at 2 months. Results: Among 1038 eligible patients, 150 were randomized to ultrasound renal denervation and 74 to a sham procedure (mean age, 55 years [SD, 9.3 years]; 28.6% female; and 16.1% self-identified as Black or African American). The reduction in daytime ambulatory SBP was greater with ultrasound renal denervation (mean, -7.9 mm Hg [SD, 11.6 mm Hg]) vs the sham procedure (mean, -1.8 mm Hg [SD, 9.5 mm Hg]) (baseline-adjusted between-group difference, -6.3 mm Hg [95% CI, -9.3 to -3.2 mm Hg], P < .001), with a consistent effect of ultrasound renal denervation throughout the 24-hour circadian cycle. Among 7 secondary BP outcomes, 6 were significantly improved with ultrasound renal denervation vs the sham procedure. No major adverse events were reported in either group. Conclusions and Relevance: In patients with hypertension, ultrasound renal denervation reduced daytime ambulatory SBP at 2 months in the absence of antihypertensive medications vs a sham procedure without postprocedural major adverse events. Trial Registration: ClinicalTrials.gov Identifier: NCT03614260.
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Desnervación , Hipertensión , Ultrasonografía Intervencional , Femenino , Humanos , Masculino , Persona de Mediana Edad , Antihipertensivos/uso terapéutico , Desnervación/métodos , Procedimientos Endovasculares , Hipertensión/cirugía , Riñón/diagnóstico por imagen , Riñón/inervación , Ultrasonografía Intervencional/métodos , Procedimientos Quirúrgicos Vasculares , Método Simple CiegoRESUMEN
OBJECTIVE: Previous studies have shown that hydrogen sulfide (H2S) exerts potent proangiogenic properties under in vitro conditions and in rodent models. We sought to determine whether a novel H2S prodrug promotes peripheral revascularization in a swine model of acute limb ischemia (ALI). METHODS: ALI was induced in 17 female miniswine via intravascular occlusion of the external iliac. At day 7 after ALI induction, miniswine (n = 17) were randomized to received placebo or the H2S prodrug, SG-1002 (800 mg per os twice a day), for 35 days. At day 35 SG-1002 increased circulating levels of H2S (5.0 ± 1.2 µmol/L vs 1.8 ± 0.50 µmol/L; P < .05), sulfane sulfur (10.6 ± 2.3 µmol/L vs 2.6 ± 0.8 µmol/L; P < .05), and nitrite (0.5 ± 0.05 µmol/L vs 0.3 ± 0.03 µmol/L; P < .005) compared with placebo. SG-1002 therapy increased angiographic scoring in ischemic limb vessel number (27.6 ± 1.6 vs 22.2 ± 1.8; P < .05) compared with placebo. Treatment with SG-1002 preserved existing capillaries in ischemic limbs (128.3 ± 18.7 capillaries/mm2 vs 79.0 ± 9.8 capillaries/mm2; P < .05) compared with placebo. Interestingly, treatment with SG-1002 also improved coronary vasorelaxation responses to bradykinin and substance P in miniswine with ALI. CONCLUSIONS: Our results suggest that daily administration of the H2S prodrug, SG-1002, leads to an increase in circulating H2S and nitric oxide signaling and preserves vessel number and density in ischemic limbs. Furthermore, SG-1002 therapy improved endothelial-dependent coronary artery vasorelaxation in the setting of ALI. Our data demonstrate that SG-1002 preserves the vascular architecture in ischemic limbs and exerts vascular protective effects in the coronary vasculature in a model of peripheral vascular disease.
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Inductores de la Angiogénesis/farmacología , Extremidades/irrigación sanguínea , Sulfuro de Hidrógeno/farmacología , Isquemia/tratamiento farmacológico , Neovascularización Fisiológica/efectos de los fármacos , Enfermedad Arterial Periférica/tratamiento farmacológico , Profármacos/farmacología , Enfermedad Aguda , Inductores de la Angiogénesis/sangre , Inductores de la Angiogénesis/farmacocinética , Animales , Vasos Coronarios/efectos de los fármacos , Vasos Coronarios/fisiopatología , Modelos Animales de Enfermedad , Femenino , Sulfuro de Hidrógeno/sangre , Sulfuro de Hidrógeno/farmacocinética , Isquemia/sangre , Isquemia/fisiopatología , Óxido Nítrico/sangre , Nitritos/sangre , Estrés Oxidativo/efectos de los fármacos , Enfermedad Arterial Periférica/sangre , Enfermedad Arterial Periférica/fisiopatología , Profármacos/farmacocinética , Flujo Sanguíneo Regional , Transducción de Señal , Porcinos , Porcinos Enanos , Vasodilatación/efectos de los fármacosRESUMEN
INTRODUCTION: Clinical trials have shown a short-term benefit of drug-eluting stents (DES) compared to vascular brachytherapy (VBT) for treatment of in-stent restenosis (ISR). The long-term benefits of DES vs. VBT are conflicting in the literature. This study aimed to do a meta-analysis of long-term outcomes of DES compared to VBT for treatment of ISR. METHODS: PubMed, EMBASE, Cochrane Central and unpublished data were searched for cohort studies and randomized controlled trials (RCTs) that directly compared VBT to DES for the treatment of ISR. We evaluated the following outcomes at 2-5 years of follow-up: target lesion revascularization (TLR), target vessel revascularization (TVR), myocardial infarction (MI), stent thrombosis, cardiovascular (CV) mortality, and overall mortality. Heterogeneity was defined as I(2) values > 25%. Review Manager 5.1 was used for statistical analysis. RESULTS: We included 1,375 patients from five studies, of which three were RCTs. VBT was used to treat ISR in 685 (49.8%) patients. After a 2-5 year follow-up, no significant differences were found between treatment groups regarding MI (P = 0.49), stent thrombosis (P = 0.86), CV mortality (P = 0.35), and overall mortality (P = 0.71). TLR (OR 2.37; CI 1.55-3.63; P < 0.001) and TVR (OR 2.23; CI 1.01-4.94; P = 0.05) were significantly increased in patients who received VBT. CONCLUSION: This study suggests that DES are associated with decreased long-term revascularization procedures when compared to VBT for the treatment of ISR. This benefit does not appear to be associated with a significant reduction in mortality or myocardial infarction.
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Braquiterapia , Reestenosis Coronaria/terapia , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea/instrumentación , Anciano , Braquiterapia/efectos adversos , Braquiterapia/mortalidad , Distribución de Chi-Cuadrado , Angiografía Coronaria , Reestenosis Coronaria/diagnóstico , Reestenosis Coronaria/mortalidad , Reestenosis Coronaria/radioterapia , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/etiología , Oportunidad Relativa , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Diseño de Prótesis , Factores de Riesgo , Trombosis/etiología , Factores de Tiempo , Resultado del TratamientoRESUMEN
INTRODUCTION: Multiple device closure (MDC) strategy has been used in treating of complex Atrial septal defects (ASDs) in adults. The safety profile of MDC compared to conventional single device closure (SDC) is unknown in this population. This report represents the first review examining the outcomes of single versus multiple device ASD closure in adults with ostium secundum defects. METHODS: Literature databases and manual search from their inception until June 30th, 2017 followed the Preferred Reporting Items of Systemic Review and Meta-Analysis (PRISMA) guideline. Main outcomes are 1) overall complication incidence, 2) arrhythmia incidence, 3) residual shunt rate. Each outcome profile was pooled by MDC and SDC, respectively and chi-square analysis was applied to examine statistical significance between MDC and SDC strategies (two-sided and p < .050). RESULTS: A total of 1806 + studies were initially screened, and 20 studies were finally selected (MDC group, 147 patients; SDC group, 1706 patients). There was no difference in overall complication incidence (χ2 = 1.269; p = .259) and arrhythmia incidence (χ2 = 0.325; p = .568) between MDC and SDC. There was no difference in residual shunt rate between the SDC (4.10 %; 70/1706) and MDC groups (6.80 %; 10/147; χ2 = 2.387; p = .122). CONCLUSIONS: The outcomes of percutaneous multiple ASD closure (MDC) seem to be safe and effective as compared to conventional single ASD (SDC) closure in terms of device - related complications and technical success of the procedure. Prospective registry data and randomized trials are needed to determine the long-term outcomes of percutaneous ASD closure using MDC.
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Defectos del Tabique Interatrial , Dispositivo Oclusor Septal , Adulto , Humanos , Resultado del Tratamiento , Defectos del Tabique Interatrial/diagnóstico por imagen , Defectos del Tabique Interatrial/terapia , Diseño de Prótesis , Arritmias Cardíacas/etiología , Cateterismo Cardíaco/efectos adversosRESUMEN
From the earliest experiences with carotid artery stenting (CAS) presumptive high risk features have included thrombus-containing lesions, heavily calcified lesions, very tortuous vessels, and near occlusions. In addition patients have been routinely excluded from CAS trials if they have contra-indications to dual antiplatelet therapy (aspirin and thienopyridines), a history of bleeding complications and severe peripheral arterial disease (PAD) making femoral artery vascular access difficult. Variables that increase the risk of CAS complications can be attributed to patient characteristics, anatomic or lesion features, and procedural factors. Clinical features such as older age (≥80 years), decreased cerebral reserve (dementia, multiple prior strokes, or intracranial microangiopathy) and angiographic characteristics such as excessive tortuosity (more than two 90° bends within 5 cm of the target lesion) and heavy calcification (concentric calcification ≥ 3 mm in width) have been associated with increased CAS complications. Other high risk CAS features include those that prolong catheter or guide wire manipulation in the aortic arch, make crossing a carotid stenosis more difficult, decrease the likelihood of successful deployment or retrieval of an embolic protection device (EPD), or make stent delivery or placement more difficult. Procedure volume for the operator and the catheterization laboratory team are critical elements in reducing the risk of the procedure. In this article, we help CAS operators better understand procedure risk to allow more intelligent case selection, further improving the outcomes of this emerging procedure.
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Angioplastia/efectos adversos , Angioplastia/instrumentación , Estenosis Carotídea/terapia , Stents , Anciano , Anciano de 80 o más Años , Angioplastia/mortalidad , Estenosis Carotídea/diagnóstico , Estenosis Carotídea/mortalidad , Competencia Clínica , Comorbilidad , Humanos , Selección de Paciente , Placa Aterosclerótica , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
Importance: Ultrasound renal denervation (uRDN) was shown to lower blood pressure (BP) in patients with uncontrolled hypertension (HTN). Establishing the magnitude and consistency of the uRDN effect across the HTN spectrum is clinically important. Objective: To characterize the effectiveness and safety of uRDN vs a sham procedure from individual patient-level pooled data across uRDN trials including either patients with mild to moderate HTN on a background of no medications or with HTN resistant to standardized triple-combination therapy. Data Sources: A Study of the ReCor Medical Paradise System in Clinical Hypertension (RADIANCE-HTN SOLO and TRIO) and A Study of the ReCor Medical Paradise System in Stage II Hypertension (RADIANCE II) trials. Study Selection: Trials with similar designs, standardized operational implementation (medication standardization and blinding of both patients and physicians to treatment assignment), and follow-up. Data Extraction and Synthesis: Pooled analysis using individual patient-level data using linear regression models to compare uRDN with sham across the trials. Main Outcomes and Measures: The primary outcome was baseline-adjusted change in 2-month daytime ambulatory systolic BP (dASBP) between groups. Results: A total of 506 patients were randomized in the 3 studies (uRDN, 293; sham, 213; mean [SD] age, 54.1 [9.3]; 354 male [70.0%]). After a 1-month medication stabilization period, dASBP was similar between the groups (mean [SD], uRDN, 150.3 [9.2] mm Hg; sham, 150.8 [10.5] mm Hg). At 2 months, dASBP decreased by 8.5 mm Hg to mean (SD) 141.8 (13.8) mm Hg among patients treated with uRDN and by 2.9 mm Hg to 147.9 (14.6) mm Hg among patients treated with a sham procedure (mean difference, -5.9; 95% CI, -8.1 to -3.8 mm Hg; P < .001 in favor of uRDN). BP decreases from baseline with uRDN vs sham were consistent across trials and across BP parameters (office SBP: -10.4 mm Hg vs -3.4 mm Hg; mean difference, -6.4 mm Hg; 95% CI, -9.1 to -3.6 mm Hg; home SBP: -8.4 mm Hg vs -1.4 mm Hg; mean difference, -6.8 mm Hg; 95% CI, -8.7 to -4.9 mm Hg, respectively). The BP reductions with uRDN vs sham were consistent across prespecified subgroups. Independent predictors of a larger BP response to uRDN were higher baseline BP and heart rate and the presence of orthostatic hypertension. No differences in early safety end points were observed between groups. Conclusions and Relevance: Results of this patient-level pooled analysis suggest that BP reductions with uRDN were consistent across HTN severity in sham-controlled trials designed with a 2-month primary end point to standardize medications across randomized groups. Trial Registration: ClinicalTrials.gov Identifier: NCT02649426 and NCT03614260.
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Hipertensión , Hipotensión , Humanos , Masculino , Persona de Mediana Edad , Antihipertensivos/uso terapéutico , Simpatectomía/métodos , Resultado del Tratamiento , Hipertensión/tratamiento farmacológico , Riñón/diagnóstico por imagen , Riñón/fisiopatologíaRESUMEN
Venous thromboembolism (VTE) is responsible for the hospitalization of >250 000 Americans annually and represents a significant risk for morbidity and mortality. Despite the publication of evidence-based clinical practice guidelines to aid in the management of VTE in its acute and chronic forms, the clinician is frequently confronted with manifestations of VTE for which data are sparse and optimal management is unclear. In particular, the optimal use of advanced therapies for acute VTE, including thrombolysis and catheter-based therapies, remains uncertain. This report addresses the management of massive and submassive pulmonary embolism (PE), iliofemoral deep vein thrombosis (IFDVT),and chronic thromboembolic pulmonary hypertension (CTEPH). The goal is to provide practical advice to enable the busy clinician to optimize the management of patients with these severe manifestations of VTE. Although this document makes recommendations for management, optimal medical decisions must incorporate other factors, including patient wishes, quality of life, and life expectancy based on age and comorbidities. The appropriateness of these recommendations for a specific patient may vary depending on these factors and will be best judged by the bedside clinician.
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Anticoagulantes/uso terapéutico , Cardiología/normas , Hipertensión Pulmonar/tratamiento farmacológico , Embolia Pulmonar/tratamiento farmacológico , Terapia Trombolítica/normas , Trombosis de la Vena/tratamiento farmacológico , American Heart Association , Vena Femoral , Humanos , Hipertensión Pulmonar/diagnóstico , Vena Ilíaca , Embolia Pulmonar/diagnóstico , Estados Unidos , Trombosis de la Vena/diagnósticoRESUMEN
BACKGROUND: Current "best" medical therapy with anti-platelet and/or anti-thrombotic agents for symptomatic atherosclerotic intracranial (IC) disease is associated with high recurrence. IC catheter-based therapy (CBT) using balloon angioplasty with or without stent placement is an option for patients who have failed medical therapy. We sought to examine the outcomes of CBT for patients with symptomatic IC arterial disease managed by experienced interventional cardiologists. METHODS: We retrospectively studied 89 consecutive symptomatic patients with 99 significant (≥70% diameter) IC arterial stenoses who underwent CBT. CBT was performed by experienced interventional cardiologists with the consultative support of a neurovascular team. The primary endpoint was stroke and vascular death. RESULTS: Procedure success was achieved in 96/99 (97%) lesions and percent diameter stenosis was reduced from 91% ± 7.5% preprocedure to 19% ± 15% postprocedure (P < 0.001). The rate of in-hospital periprocedural stroke and all death was 3%. The primary endpoint of stroke and vascular death rate at 1 year was 5.7% (5/88) and at 2 years was 13.5% (11/81). The 2-year all-cause mortality was 11.3% (10/88). CONCLUSIONS: For patients with symptomatic IC arterial stenosis who have failed medical therapy or are considered very high risk for stroke, CBT performed by experienced interventional cardiologists is safe and offers both high procedural success rates and excellent clinical outcomes at 1 year. CBT is an attractive option for this high-risk patient population considering the expected 12-15% rate of recurrent stroke at 1 year.
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Angioplastia de Balón , Infarto de la Arteria Cerebral Media/terapia , Arteriosclerosis Intracraneal/terapia , Anciano , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/instrumentación , Angioplastia de Balón/mortalidad , Angiografía Cerebral , Supervivencia sin Enfermedad , Femenino , Mortalidad Hospitalaria , Humanos , Infarto de la Arteria Cerebral Media/complicaciones , Infarto de la Arteria Cerebral Media/diagnóstico por imagen , Infarto de la Arteria Cerebral Media/mortalidad , Arteriosclerosis Intracraneal/complicaciones , Arteriosclerosis Intracraneal/diagnóstico por imagen , Arteriosclerosis Intracraneal/mortalidad , Ataque Isquémico Transitorio/etiología , Ataque Isquémico Transitorio/mortalidad , Ataque Isquémico Transitorio/prevención & control , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Nueva Orleans , Recurrencia , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Stents , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/mortalidad , Accidente Cerebrovascular/prevención & control , Factores de Tiempo , Resultado del TratamientoRESUMEN
Importance: Although early trials of endovascular renal denervation (RDN) for patients with resistant hypertension (RHTN) reported inconsistent results, ultrasound RDN (uRDN) was found to decrease blood pressure (BP) vs sham at 2 months in patients with RHTN taking stable background medications in the Study of the ReCor Medical Paradise System in Clinical Hypertension (RADIANCE-HTN TRIO) trial. Objectives: To report the prespecified analysis of the persistence of the BP effects and safety of uRDN vs sham at 6 months in conjunction with escalating antihypertensive medications. Design, Setting, and Participants: This randomized, sham-controlled, clinical trial with outcome assessors and patients blinded to treatment assignment, enrolled patients from March 11, 2016, to March 13, 2020. This was an international, multicenter study conducted in the US and Europe. Participants with daytime ambulatory BP of 135/85 mm Hg or higher after 4 weeks of single-pill triple-combination treatment (angiotensin-receptor blocker, calcium channel blocker, and thiazide diuretic) with estimated glomerular filtration rate (eGFR) of 40 mL/min/1.73 m2 or greater were randomly assigned to uRDN or sham with medications unchanged through 2 months. From 2 to 5 months, if monthly home BP was 135/85 mm Hg or higher, standardized stepped-care antihypertensive treatment starting with aldosterone antagonists was initiated under blinding to treatment assignment. Interventions: uRDN vs sham procedure in conjunction with added medications to target BP control. Main Outcomes and Measures: Six-month change in medications, change in daytime ambulatory systolic BP, change in home systolic BP adjusted for baseline BP and medications, and safety. Results: A total of 65 of 69 participants in the uRDN group and 64 of 67 participants in the sham group (mean [SD] age, 52.4 [8.3] years; 104 male [80.6%]) with a mean (SD) eGFR of 81.5 (22.8) mL/min/1.73 m2 had 6-month daytime ambulatory BP measurements. Fewer medications were added in the uRDN group (mean [SD], 0.7 [1.0] medications) vs sham (mean [SD], 1.1 [1.1] medications; P = .045) and fewer patients in the uRDN group received aldosterone antagonists at 6 months (26 of 65 [40.0%] vs 39 of 64 [60.9%]; P = .02). Despite less intensive standardized stepped-care antihypertensive treatment, mean (SD) daytime ambulatory BP at 6 months was 138.3 (15.1) mm Hg with uRDN vs 139.0 (14.3) mm Hg with sham (additional decreases of -2.4 [16.6] vs -7.0 [16.7] mm Hg from month 2, respectively), whereas home SBP was lowered to a greater extent with uRDN by 4.3 mm Hg (95% CI, 0.5-8.1 mm Hg; P = .03) in a mixed model adjusting for baseline and number of medications. Adverse events were infrequent and similar between groups. Conclusions and Relevance: In this study, in patients with RHTN initially randomly assigned to uRDN or a sham procedure and who had persistent elevation of BP at 2 months after the procedure, standardized stepped-care antihypertensive treatment escalation resulted in similar BP reduction in both groups at 6 months, with fewer additional medications required in the uRDN group. Trial Registration: ClinicalTrials.gov Identifier: NCT02649426.
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Antihipertensivos , Hipertensión , Humanos , Masculino , Persona de Mediana Edad , Antihipertensivos/uso terapéutico , Antagonistas de Receptores de Mineralocorticoides/uso terapéutico , Resultado del Tratamiento , Hipertensión/tratamiento farmacológico , Hipertensión/cirugía , Desnervación/métodosRESUMEN
The objective of this paper is to describe outcomes of endovascular therapy in patients with symptomatic common femoral artery (CFA) lesions. Symptomatic atherosclerotic disease of the common femoral artery is an uncommon clinical entity, and there is no consensus regarding the suitability of catheter-based therapy. We reviewed the records of 26 consecutive patients treated with catheter-based therapy for symptomatic CFA lesions between 1994 and 2009. Angiographic success and procedure success were obtained in all vessels and in all patients. At 1 year, 100% (16/16) of the claudication patients and 70% (7/10) of the critical limb ischemia (CLI) patients maintained clinical success. The ankle- brachial index (ABI) significantly improved from a baseline of 0.47 ± 0.18 to 0.77 ± 0.18 (p < 0.001) after the procedure. At their most recent clinic visit (31 months ± 14 months), clinical success was maintained in 100% of the claudication patients and in 70% (7/10) of the CLI patients. During the follow-up period, femoral vascular access for an unrelated procedure was obtained through the CFA stent. In conclusion, patients with symptomatic CFA atherosclerotic disease obtained excellent clinical outcomes with angioplasty with stenting. We found that angioplasty with stenting of the CFA did not preclude future CFA vascular access. Our data suggest that catheter-based therapies should be considered as an option to open surgery in selected patients with symptomatic CFA disease.
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Aterectomía/métodos , Aterosclerosis/terapia , Arteria Femoral , Anciano , Anciano de 80 o más Años , Angiografía , Índice Tobillo Braquial , Aterosclerosis/diagnóstico por imagen , Aterosclerosis/fisiopatología , Catéteres de Permanencia , Supervivencia sin Enfermedad , Femenino , Humanos , Claudicación Intermitente/terapia , Isquemia/terapia , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , StentsRESUMEN
Clinically evident and subclinical peri-procedural bleeding following interventional therapies are associated with adverse cardiovascular outcomes. The risk factors for clinically evident bleeding have been well described. Despite the well-documented association of adverse outcomes for patients with a subclinical peri-procedural hemoglobin drop, the clinical predictors have not yet been defined. We identified 1176 consecutive patients with a subclinical drop in hemoglobin (fall of ≥ 1 g/dl in patients without clinical bleeding) following percutaneous coronary interventions (PCI) and peripheral vascular interventions (PVI). Multivariate logistic regression analysis was performed. A subclinical peri-procedural hemoglobin drop ≥ 1 g/dl was identified in 41% (400/972) of PCI and in 49% (213/435) of PVI. More than one access site predicted a higher risk of a subclinical drop in hemoglobin in both groups. A body mass index ≥ 30 predicted a lower risk of a subclinical drop in hemoglobin in both groups. For PCI, creatinine clearance < 60 ml/min was associated with a higher risk of a subclinical drop in hemoglobin. In conclusion, clinically silent peri-procedural hemoglobin fall ≥ 1 g/dl is common in patients undergoing both coronary and peripheral percutaneous intervention. Predictors identified in our study will need prospective validation.
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Angioplastia Coronaria con Balón/efectos adversos , Enfermedad de la Arteria Coronaria/terapia , Hemoglobinas/metabolismo , Enfermedad Arterial Periférica/terapia , Hemorragia Posoperatoria/etiología , Anciano , Índice de Masa Corporal , Estudios de Cohortes , Enfermedad de la Arteria Coronaria/sangre , Creatinina/metabolismo , Femenino , Humanos , Fallo Renal Crónico/metabolismo , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/sangre , Hemorragia Posoperatoria/sangre , Estudios Retrospectivos , Factores de RiesgoRESUMEN
Symptomatic vertebral artery stenosis is associated with high risk of early recurrent stroke. Vertebral artery stenosis can be treated with angioplasty and stenting with good technical results. In this review we outline the framework for the diagnosis and management of vertebral artery disease with focus on the emerging benefits of angiography and endovascular interventions.
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Angioplastia , Endarterectomía , Injerto Vascular , Arteria Vertebral/cirugía , Insuficiencia Vertebrobasilar/terapia , Angioplastia/efectos adversos , Angioplastia/instrumentación , Endarterectomía/efectos adversos , Humanos , Recurrencia , Factores de Riesgo , Stents , Resultado del Tratamiento , Injerto Vascular/efectos adversos , Grado de Desobstrucción Vascular , Arteria Vertebral/diagnóstico por imagen , Arteria Vertebral/fisiopatología , Insuficiencia Vertebrobasilar/diagnóstico por imagen , Insuficiencia Vertebrobasilar/fisiopatologíaRESUMEN
A lack of preclinical large animal models of heart failure with preserved ejection fraction (HFpEF) that recapitulate this comorbid-laden syndrome has led to the inability to tease out mechanistic insights and to test novel therapeutic strategies. This study developed a large animal model that integrated multiple comorbid determinants of HFpEF in a miniswine breed that exhibited sensitivity to obesity, metabolic syndrome, and vascular disease with overt clinical signs of heart failure. The combination of a Western diet and 11-deoxycorticosterone acetate salt-induced hypertension in the Göttingen miniswine led to the development of a novel large animal model of HFpEF that exhibited multiorgan involvement and a full spectrum of comorbidities associated with human HFpEF.
RESUMEN
Hypertension affects millions of Americans and has adverse long-term consequences increasing morbidity and mortality. Resistant hypertension (RH) continues to be difficult to treat with medications alone which may be associated with significant side effects. Alternate therapies have been evaluated for treating RH and renal denervation has been investigated extensively. We review the data from renal denervation trials and other novel technologies which are not FDA approved to date.
Asunto(s)
Técnicas de Ablación , Presión Sanguínea , Resistencia a Medicamentos , Hipertensión/cirugía , Riñón/irrigación sanguínea , Arteria Renal/inervación , Simpatectomía , Técnicas de Ablación/efectos adversos , Antihipertensivos/uso terapéutico , Presión Sanguínea/efectos de los fármacos , Quimioterapia Combinada , Humanos , Hipertensión/diagnóstico , Hipertensión/epidemiología , Hipertensión/fisiopatología , Factores de Riesgo , Simpatectomía/efectos adversos , Resultado del TratamientoRESUMEN
BACKGROUND: Paravalvular leaks (PVLs) are a well-recognized complication of prosthetic valves that are detected up to 18% of all implanted surgical valves. Perioperative morbidity is thought to be lower in percutaneous compared to surgical PVL repair. However, a direct comparison of PVL closure techniques has never been performed. Our study is the first to demonstrate that elective PVL closure with monitored anesthesia care can be achieved with high success and low complications rates resulting in short hospital stays. METHODS: This is a retrospective cohort of patients admitted electively for catheter-based treatment of symptomatic prosthetic paravalvular regurgitation from Jan 2013 to April 2018. Both mitral and aortic PVLs were included. Patients' demographics, risk factors, procedural outcomes, In-hospital and thirty-day mortality were all reported. We followed the Valve Academic Research Consortium (VARC) criteria to define device and procedural technical success. In-hospital and 30- day outcomes were assessed by retrospective chart review. RESULTS: A total of 54 PVLs in thirty-seven patients were repaired (65% aortic & 35% mitral). The mean-age in the mitral cohort was lower than the aortic cohort (61 vs 72years, P<0.0001) but the two groups shared similar clinical risk factors (P>0.05). Average hospital stay was 1-2days (<1.5days overall cohort) which was significantly lower in the aortic compared to the mitral cohort (P=0.009). All procedures were guided by TEE under conscious sedation with monitored anesthesia care. Procedural technical success defined as any significant residual shunt was 81% in the overall cohort and 88% in the aortic group. No procedural deaths were reported. Short-term mortality during the first 30days was 5.4% (two patients). CONCLUSION: Elective catheter-based repair of symptomatic prosthetic paravalvular regurgitation appears to be safe and effective. The use of conscious sedation with monitored anesthesia care resulted in short hospital stay.
Asunto(s)
Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Insuficiencia de la Válvula Mitral , Anciano , Cateterismo Cardíaco , Sedación Consciente , Humanos , Persona de Mediana Edad , Insuficiencia de la Válvula Mitral/cirugía , Falla de Prótesis , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
OBJECTIVES: To report the technical success and clinical outcomes of catheter-based therapy (CBT) for acute ischemic stroke in patients ineligible for intravenous thrombolysis. BACKGROUND: Acute ischemic stroke is common but undertreated. CBT for acute ischemic stroke is a therapeutic option in selected patients who are not candidates for intravenous thrombolysis. METHODS: Consecutive stroke patients who were ineligible for intravenous thrombolysis and underwent CBT were identified by retrospective chart review. Demographic information, National Institutes of Health Stroke Scale (NIHSS), procedural characteristics, and clinical outcomes during hospitalization and at 90 days follow up were collected. Experienced interventional cardiologists with the consultative support of stroke neurologists were on call for acute strokes. RESULTS: A total of 33 acute ischemic stroke patients underwent emergency cerebral angiography, with 26 patients undergoing CBT. Successful "culprit" artery recanalization was achieved in 23 (88%) of the 26 patients. In-hospital adverse events occurred in 4 (15%) patients, with intracerebral hemorrhage (ICH) (12%) representing the most common adverse event. The baseline NIHSS for patients who underwent intervention was 16.5 +/- 9.9 (median 16) and improved significantly to 9.9 +/- 8.7 (median 9) (P < 0.001) at hospital discharge. A modified Rankin score of two or less (indicating mild disability) was achieved in half (n = 13) of the CBT treated patients. All cause mortality at 90 days was 8% (2/26). CONCLUSIONS: In selected patients, CBT provided by qualified interventional cardiologists supported by stroke neurologists, offers a safe and effective option for patients with acute stroke who are not eligible for intravenous thrombolysis.
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Angioplastia de Balón , Isquemia Encefálica/complicaciones , Cardiología/métodos , Angiografía Cerebral , Radiografía Intervencional , Radiología Intervencionista/métodos , Accidente Cerebrovascular/terapia , Anciano , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/instrumentación , Isquemia Encefálica/diagnóstico por imagen , Isquemia Encefálica/mortalidad , Isquemia Encefálica/terapia , Conducta Cooperativa , Evaluación de la Discapacidad , Embolectomía , Femenino , Humanos , Hemorragias Intracraneales/etiología , Hemorragias Intracraneales/mortalidad , Masculino , Persona de Mediana Edad , Neurología , Grupo de Atención al Paciente , Admisión y Programación de Personal , Derivación y Consulta , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Stents , Accidente Cerebrovascular/diagnóstico por imagen , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/mortalidad , Terapia Trombolítica/efectos adversos , Factores de Tiempo , Resultado del TratamientoRESUMEN
Sudden cardiac death (SCD) is a major public health issue in the United States and worldwide. It is estimated to affect between 1 and 1.5 million patients worldwide annually, with the global burden expected to rise due to the concomitant rise in coronary artery disease in the developing world. Although arrhythmic causes of SCD such as ventricular tachycardia and ventricular fibrillation are common and well-studied, non-arrhythmic causes are also important, with diverse etiologies from ischemia-related structural heart disease to non-ischemic heart diseases, non-atherosclerotic coronary pathologies, and inflammatory states. Recent research has also found that risk factors and/or demographics predispose certain individuals to a higher risk of non-arrhythmia-related SCD. This review discusses the epidemiology, mechanisms, etiologies, and management of non-arrhythmic SCD.
Asunto(s)
Enfermedad Coronaria/complicaciones , Muerte Súbita Cardíaca/etiología , Infarto del Miocardio/complicaciones , Adulto , Aneurisma Coronario/complicaciones , Aneurisma Coronario/diagnóstico por imagen , Muerte Súbita Cardíaca/epidemiología , Humanos , Lactante , Factores de Riesgo , Tomografía Computarizada por Rayos XRESUMEN
OBJECTIVE: We investigated whether repeat renal artery stent placement compared with treatment with balloon angioplasty alone results in better patency in patients presenting with renal artery in-stent restenosis (ISR). BACKGROUND: Although stent placement for renal artery stenosis has been demonstrated to be superior to balloon angioplasty for "de novo" renal artery lesions, the optimal therapy for ISR remains unclear. METHODS: Between January 1997 and August 2006, 34 consecutive patients (41 renal arteries) with ISR were treated at the discretion of the operator with balloon angioplasty or repeat stent placement. Quantitative angiography was performed before and immediately after intervention and at follow-up. Angiographic follow-up was obtained for clinical indications in 75% of lesions and routine noninvasive follow-up imaging was obtained in 95% of lesions. RESULTS: Repeat renal artery stent placement demonstrated improved patency compared with balloon angioplasty alone with a 58% reduction in recurrent ISR (29.4% vs. 71.4%, P = 0.02) and a 30% reduction in follow-up diameter stenosis (41% vs. 58.2%, P = 0.03). The repeat stent group also had better secondary patency (P = 0.05) and a greater freedom from repeat ISR (P = 0.01) when compared with balloon angioplasty alone. There was a trend favoring repeat stent placement for cumulative freedom from target vessel revascularization (TVR) (P = 0.08). CONCLUSIONS: Repeat stent placement appears to result in superior patency compared with balloon angioplasty alone for the treatment of renal ISR.
Asunto(s)
Angioplastia de Balón/efectos adversos , Obstrucción de la Arteria Renal/terapia , Stents , Grado de Desobstrucción Vascular , Anciano , Angioplastia de Balón/instrumentación , Femenino , Estudios de Seguimiento , Humanos , Masculino , Metales , Persona de Mediana Edad , Diseño de Prótesis , Radiografía , Obstrucción de la Arteria Renal/diagnóstico por imagen , Obstrucción de la Arteria Renal/fisiopatología , Proyectos de Investigación , Estudios Retrospectivos , Medición de Riesgo , Prevención Secundaria , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Carotid artery stent (CAS) placement is an alternative to carotid endarterectomy (CEA) for stroke prevention. Clinical adoption of CAS depends on its safety and efficacy compared to CEA. There are conflicting reports in the literature regarding the safety of CAS in the elderly. To address these safety concerns, we report our single-center 13-year CAS experience in very elderly (> or =80 years of age) patients. METHODS: Between 1994 and 2007, 816 CAS procedures were performed at the Ochsner Clinic Foundation. Very elderly patients, those > or =80 years of age, accounted for 126 (15%) of all CAS procedures. Independent neurologic examination was performed before and after the CAS procedure. RESULTS: The average patient age was 82.9 +/- 2.9 years. Almost one-half (44%) were women and 40% were symptomatic from their carotid stenoses. One-third of the elderly patients met anatomic criteria for high surgical risk as their indication for CAS. The procedural success rate was 100% with embolic protection devices used in 50%. The 30-day major adverse coronary or cerebral events (MACCE) rate was 2.7% (n = 3) with all events occurring in the symptomatic patient group [death = 0.9% (n = 1), myocardial infarction = 0%, major (disabling) stroke = 0.9% (n = 1), and minor stroke = 0.9% (n = 1)]. CONCLUSION: Elderly patients, > or =80 years of age, may undergo successful CAS with a very low adverse event rate as determined by an independent neurological examination. We believe that careful case selection and experienced operators were keys to our success.