ABSTRACT
La denervación de las arterias renales ha sido una alternativa para el tratamiento de la hipertensión arterial resistente. Los estudios Symplicity HTN 1 y 2 mostraron en grupos pequeños y no controlados disminuciones de la presión sistólica hasta de 30 mm Hg. Este entusiasmo ha sido opacado por el estudio Symplicity HTN 3, ensayo clínico aleatorizado y controlado con un procedimiento placebo. Sorprendentemente, los resultados sugirieron que la denervación renal tuvo un efecto similar al del placebo, aunque en el análisis de subgrupos preespecificados los pacientes que no eran de raza negra, los menores de 65 años y los que tenían función renal normal tuvieron una reducción de la presión arterial sistólica estadísticamente significativa. Esta es una evaluación crítica de los resultados del Symplicity HTN 3 y propone posibles explicaciones para estos. Además, declara la postura de nuestro grupo y las acciones futuras.
Renal artery denervation has shown to be an effective treatment for resistant hypertension. Symplicity HTN 1 and 2 trials showed in small and uncontrolled groups, significant systolic blood pressure reductions down to 30 mm Hg. Symplicity HTN-3, a double blind, randomized, placebo controlled clinical trial shaded this initial enthusiasm. Surprisingly, their results showed that renal denervation has a similar effect to placebo. Pre-specified subgroup analysis showed that non-black race individuals, younger than 65 years and with normal renal function, had a statistically significant systolic blood pressure decrease. This manuscript critically appraises the Symplicity HTN-3 trial, proposing possible explanations for the results. Also declares our group position and future actions regarding renal denervation.
Subject(s)
Humans , Denervation , Hypertension/surgery , Kidney/innervation , Kidney/surgery , Randomized Controlled Trials as TopicABSTRACT
Renal artery denervation has shown to be an effective treatment for resistant hypertension. Symplicity HTN 1 and 2 trials showed in small and uncontrolled groups, significant systolic blood pressure reductions down to 30 mm Hg. Symplicity HTN-3, a double blind, randomized, placebo controlled clinical trial shaded this initial enthusiasm. Surprisingly, their results showed that renal denervation has a similar effect to placebo. Pre-specified subgroup analysis showed that non-black race individuals, younger than 65 years and with normal renal function, had a statistically significant systolic blood pressure decrease. This manuscript critically appraises the Symplicity HTN-3 trial, proposing possible explanations for the results. Also declares our group position and future actions regarding renal denervation.
Subject(s)
Denervation , Hypertension/surgery , Kidney/innervation , Kidney/surgery , Randomized Controlled Trials as Topic , HumansABSTRACT
AIM: To assess the safety and efficacy of the intracoronary infusion of CD133+ hematopoietic stem cells to improve ventricular function and quality of life in candidates for heart transplantation due to post-infarct chronic heart failure. METHODS: We selected seven candidates for heart transplantation (six males/one female, age range 44-65 years) in whom all treatment alternatives were exhausted (angioplasty/stent and bypass surgery). These subjects had a symptomatic New York Heart Association (NYHA) scale of at least II and ejection fractions (EFs) below 35%. After obtaining informed consent, CD133+ cells were obtained by stimulation with granulocyte-colony stimulating factor, apheresis, and separation with magnetic beads. Stem cells were implanted in the infarcted zone via intracoronary percutaneous angiography. Evaluations (NYHA scale classification, plasma concentration of pro-B-natriuretic-peptide and the risk of sudden death, echocardiography, cardiac magnetic resonance, and gated-SPECT with MIBI) were performed at baseline and at 3, 6, 12, and 24 months after cell infusion. RESULTS: Stem cell isolation was efficient and safe (around 10(7) cells/patient and >92% CD133+ viable cells). Two patients died during observation due to noncardiac conditions. In the five remaining subjects, the NYHA scale improved and no accounts of hospital admissions for heart failure were documented. Plasma concentrations of pro-B-natriuretic peptide and the risk of sudden death clearly decreased, while the EF increased significantly to 35% and 40% by echocardiography and cardiac MRI, respectively (P=.013 and .009, respectively) 24 months after treatment. No other major adverse events were noticed. CONCLUSIONS: The intracoronary inoculation of CD133+ stem cells was safe and effective to improve ventricular contraction and symptomatic class function in patients with refractory post-infarct heart failure.
