Comparison of two different radiofrequency ablation systems for renal artery denervation: Evaluation of short‐term and long‐term follow up

Abstract

Objectives To assess the clinical efficacy of renal artery denervation (RAD) in our center and to compare the efficacy of two different radiofrequency (RF) systems. Background Several systems are available for RF renal denervation. Whether there is a difference in clinical efficacy among various systems remains unknown. Methods Renal artery denervation was performed on 43 patients with resistant hypertension using either the single electrode Symplicity Flex (n = 20) or the multi‐electrode EnligHTN system (n = 23). Median post‐procedural follow‐up was 32.93 months. The primary outcome was post‐procedural change in office blood pressure (BP) within 1 year (short‐term follow‐up). Secondary outcomes were change in office BP between 1 and 4 years (long‐term follow‐up) and the difference in office BP reduction between the two systems at each follow‐up period. Results For the total cohort, mean baseline office BP (systolic/diastolic) was 174/94 mmHg. At follow‐up, mean changes in office BP from baseline were −19.70/−11.86 mmHg ( P < 0.001) and −21.90/−13.94 mmHg ( P < 0.001) for short‐term and long‐term follow‐up, respectively. The differences in office BP reduction between Symplicity and EnligHTN groups were 8.96/1.23 mmHg ( P = 0.42 for systolic BP, P = 0.83 for diastolic BP) and 9.56/7.68 mmHg ( P = 0.14 for systolic BP, P = 0.07 for diastolic BP) for short‐term and long‐term follow‐up, respectively. Conclusions In our cohort, there was a clinically significant office BP reduction after RAD, which persisted up to 4 years. No significant difference in office BP reduction between the two systems was found.

Long‐Term Safety and Efficacy of Transcatheter Microwave and Radiofrequency Denervation in a Chronic Ovine Model

“…However, previous studies have shown that the EnligHTN is similar to the Simplicity radiofrequency system available clinically. 3 , 21 …”

Comparison of ablation characteristics of three different radiofrequency applicators in renal sympathetic denervation

“…The results indicated no change in serum creatinine after RF-RDN, no augmentation of medial damage or neointimal formation in the renal artery, and no or minimal damage to surrounding tissue. AI Raisi et al [12][13][14][15] conducted a series of experimental evaluations to investigate the efficacy of different RDN, including the Symplicity Flex system, EnligHTN system, and Symplicity Spyral system, and compared their lesion sizes to illustrate the ablation effect of different systems.…”

Denervação simpática renal por cateter na insuficiência cardíaca secundária à doença de Chagas: estudo piloto controlado randomizado

“…A eficácia da DSRC, portanto, pode depender do tipo de dispositivo, da modalidade de entrega de energia e, ainda, das técnicas de ablação utilizadas. Assim, questionamentos sobre qual dispositivo de radiofrequência[154][155][156] ou qual modalidade de energia empregada para ablação pode atingir maiores graus de danos aos nervos renais, que se traduzam em benefícios clínicos mais consistentes, permanecem sem respostas conclusivas e requerem estudos experimentais e clínicos adicionais. No entanto, a despeito de sua amostra pequena, o estudo incluiu um braço controlado, que constitui uma característica chave para avaliar com mais clareza o braço ativo, particularmente nesse contexto de pacientes de alto risco e prognóstico desfavorável, com taxas potencialmente elevadas de eventos adversos naturais durante o seguimento clínico.…”