Original article
Renal denervation for the treatment of resistant hypertension in Spain. The Flex-Spyral RegistryDenervación renal para el tratamiento de la hipertensión arterial resistente en España. Registro Flex-Spyral

https://doi.org/10.1016/j.rec.2019.08.001Get rights and content

Abstract

Introduction and objectives

Renal denervation is a percutaneous intervention for the treatment of resistant hypertension. Randomized studies have shown contradictory results on its efficacy. We present the results of a renal denervation registry for the treatment of resistant hypertension in real-life patients in Spain.

Methods

Multicenter registry of consecutive patients with resistant hypertension treated with renal denervation in Spain between 2009 and 2018.

Results

We included 125 patients (mean age, 56 years; 41% female; mean onset of hypertension 14 ± 9 years previously). Office systolic and diastolic blood pressure and ambulatory blood pressure monitoring decreased 6 months after the intervention (166 ± 20/95 ± 16 to 149 ± 22/87 ± 16 mmHg and 151 ± 14/89 ± 12 to 143 ± 15/84 ± 11, both P < .0001). At 12 months, the blood pressure reduction was maintained and the number of antihypertensive drugs decreased from 4.9 ± 1.2 to 4.4 ± 1.5 (P = .0001). There were no significant procedure-related complications. The response rate to denervation at 1 year was 80%, but there were wide differences between centers.

Conclusions

In patients with resistant hypertension, treatment with renal denervation was related to a decrease in office blood pressure and, more importantly, in ambulatory blood pressure monitoring, with a significant reduction in pharmacological treatment.

Resumen

Introducción y objetivos

La denervación renal es una intervención percutánea para el tratamiento de la hipertensión arterial resistente. Estudios aleatorizados han mostrado resultados contradictorios sobre su eficacia. Se presentan los resultados de un registro de denervación en pacientes con hipertensión resistente según práctica clínica en España.

Métodos

Registro multicéntrico de pacientes consecutivos con hipertensión arterial resistente tratados con denervación renal en España en el periodo 2009-2018.

Resultados

Se ha incluido a 125 pacientes (media de edad, 56 ± años; el 41% mujeres; media de 14 ± 9 años de evolución de la hipertensión). La presión arterial sistólica y diastólica en la consulta y ambulatoria de 24 h disminuyeron a los 6 meses de la intervención (de 166 ± 20/95 ± 16 a 149 ± 22/87 ± 16 mmHg y de 151 ± 14/89 ± 12 a 143 ± 15/84 ± 11; ambas, p < 0,0001). A los 12 meses se mantenía la reducción en la presión arterial con una disminución en el número de fármacos antihipertensivos de 4,9 ± 1,2 a 4,4 ± 1,5 (p = 0,0001). No hubo complicaciones importantes relacionadas con el procedimiento. La tasa de respuesta a la denervación al año fue del 80%, si bien con una amplia variabilidad entre centros.

Conclusiones

La denervación renal en pacientes con hipertensión resistente se relacionó con una disminución de las cifras de presión arterial en la consulta y, lo que es más importante, en la monitorización ambulatoria de presión arterial, con una disminución significativa del tratamiento farmacológico.

Section snippets

INTRODUCTION

Hypertension is the most prevalent modifiable cardiovascular risk factor, affecting more than 1 billion people worldwide and causing the death of more than 9 million people each year.1 Observational studies have revealed a progressive association between elevated blood pressure (BP) and the development of cardiovascular disease,2 with an increase of 20 mmHg in systolic BP and of 10 mmHg in diastolic BP, doubling the risk of cardiovascular death.3

Despite efforts to control the condition, data from

METHODS

This multicenter registry with retrospective data collection included consecutive patients with resistant hypertension who underwent pRDN with SYMPLICITY FLEX (2009-2015) or SPYRAL (2015-2018) catheter in 7 Spanish centers.

Study population

During the study period, pRDN was performed in 125 patients. The baseline characteristics of the patients included in the registry are summarized in table 1.

Percutaneous renal denervation procedure

The pRDN procedure was successfully completed in the 125 patients. No data were collected on the anatomy of the renal arteries, presence of polar arteries, or number or location of radiofrequency ablations. In all patients, the procedure was performed via femoral access. There were no immediate renal complications related to the

DISCUSSION

Analysis of the data from this multicenter registry of patients with resistant hypertension treated with pRDN in a real-life setting has shown that the treatment effectively decreases office BP and, more importantly, ABPM values, with a reduction in the number of antihypertensive drugs taken by the patients. The procedure was safe, with a very low rate of intervention-related complications. The success of the intervention was independent of the type of radiofrequency catheter used, although

CONCLUSIONS

In real-world patients with resistant hypertension treated with radiofrequency-based pRDN, there is a fall in office BP and, more importantly, 24-hour ABPM values in up to 80% of patients, with a significant decrease in drug therapy. The procedure is safe, with a very low rate of intervention-related complications. The pRDN response is independent of the type of radiofrequency catheter used, although there is significant variability in the response rate per center.

CONFLICTS OF INTEREST

None.

WHAT IS KNOWN ABOUT THE TOPIC?

  • Renal denervation is an intervention for the treatment of resistant hypertension that has shown contradictory efficacy results.

  • Three recent randomized studies with a small number of patients and short follow-up showed that denervation was effective in the control of moderate hypertension in patients without pharmacological treatment or with incomplete treatment.

WHAT DOES THIS STUDY ADD?

  • This work shows the denervation results of real-world patients with resistant hypertension in Spain, with a significant

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