Validation of a Novel Renal Denervation System With Cryoablation

Ji, Meng; Chen, Han; Shen, Li; Zhang, Yi; Yao, Zhifeng; Wu, Yizhe; Xu, Yawei; Ge, Junbo

doi:10.1016/j.jacbts.2021.11.002

Cited by 6 publications

(5 citation statements)

References 32 publications

(37 reference statements)

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“…All trials demonstrated that the RDN group outperformed the sham group. Furthermore, alcohol-mediated denervation and cryo-RDN are being studied to demonstrate their short-term efficacy and safety, and initial data demonstrate that the two systems have a high potential [ 46 , [57] , [58] , [59] ], whilst high-frequency non-focused US was studied in RDN and PADN with the TIVUS system, which got FDA approval, demonstrating good safety and efficacy results [ 60 , 61 ] (see Table 1 ).…”

Section: Renal Denervationmentioning

confidence: 99%

Device's design and clinical perspectives for resistant hypertension therapy

Jami,

Oussama,

Mohammed

et al. 2024

International Journal of Cardiology Cardiovascular Risk and Pre

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Section: Renal Denervationmentioning

confidence: 99%

Device's design and clinical perspectives for resistant hypertension therapy

Jami,

Oussama,

Mohammed

et al. 2024

International Journal of Cardiology Cardiovascular Risk and Pre

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“…All trials have shown the superiority of RDN group over sham group. In addition, alcohol-mediated denervation and Cryo-RDN are undergoing research to demonstrate their shortterm efficacy and safety, and the preliminary results indicate a promising future for both systems [38,[50][51][52], whereas the high-frequency non-focused ultrasound was investigated in both RDN and PADN (Pulmonary Artery Denervation) with the TIVUS system which received FDA Investigational Device Exemption (IDE) approval, showing good safety and efficacy results [53,54].…”

Section: Renal Denervationmentioning

confidence: 99%

Device-Based Therapy for Resistant Hypertension: An Up‐to‐Date Review

Jami

Tijani

Ettahir

2022

High Blood Press Cardiovasc Prev

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Hypertension is the major risk factor for cardiovascular morbidity and mortality. Matter of fact, untreated hypertension can worsen the overall health, whereas pharmacotherapy can play an important role in lowering the risk of high blood pressure in hypertensive patients. However, persistent uncontrolled hypertension remains an unsolved condition characterized by non-adherence to medication and increased sympathetic activity. This paper will review the non-pharmacological treatments for resistant hypertension (RH) that have emerged in recent years. In addition, the technologies developed in device-based RH therapy, as well as the clinical trials that support their use, will be discussed. Indeed, the novel device-based approaches that target RH present a promising therapy which has been supported by several studies and clinical trials, whereas drug non-adherence and high sympathetic activity are known to be the main causes of RH. Nevertheless, some additional aspects of these RH systems need to be tested in the near future, with a particular focus on the device's design and availability of randomized controlled trials.

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“…9,10 Radiofrequency ablation is the most commonly used method, and other methods include cryoablation and ultrasound ablation. Meng and colleagues 11 used a cryoablation catheter and found a reduction in 24-h SBP and DBP of 12.17 Our analysis was restricted to patients free of antihypertensive medications at baseline. Patients were then divided into two groups based on a coin toss.…”

Section: Introductionmentioning

confidence: 99%

“…Radiofrequency ablation is the most commonly used method, and other methods include cryoablation and ultrasound ablation. Meng and colleagues 11 used a cryoablation catheter and found a reduction in 24‐h SBP and DBP of 12.17 ± 8.35 mmHg and 8.50 ± 3.83 mmHg, respectively, over a 6‐month follow‐up ( n = 6). Two additional clinical studies used ultrasound ablation catheters.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of 3D reconstruction and basket multi‐electrode renal denervation (RDN) for refractory hypertensive patients with chronic kidney disease

Cai,

Fang,

et al. 2024

J of Clinical Hypertension

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Renal Artery Sympathetic Denervation (RDN) can lower blood pressure. Different ablation catheters (single electrode, multi‐electrode) have different scopes of ablation (renal artery main stem and branches). Few studies have compared the advantages and disadvantages of different ablation catheters and different procedures in terms of antihypertensive efficacy. To compare the efficacy and safety of 3D reconstruction radiofrequency ablation (3DRA) and basket multi‐electrode radiofrequency ablation (BMRA) in Renal Artery Sympathetic Denervation. Fifty‐three patients with Refractory hypertension (RHT) were divided into BMRA, (n = 28) and 3DRA(n = 25). BMRA group used a stereobasket multi‐electrode ablation catheter with a controlled ablation temperature of 60°C and an ablation time of 120 s per site. 3DRA group used a NavStar pressure‐monitored perfusion monopolar ablation catheter with a controlled ablation temperature of 40°C, an ablation time of 40 s per site, and an ablation energy of 12 W. Baseline and RDN parameters and complications were compared in both groups. Home and 24 h ambulatory blood pressure, type of anti‐hypertensive medication taken, and serum creatinine were followed up at 1, 3, 6, 12, and 24 months after the RDN. There were no differences in baseline characteristics between the two groups. (23.14 ± 2.00)months of follow‐up in the BMRA group resulted in a total of (25.86 ± 8.61) loci ablation. (19.28 ± 7.40)months of follow‐up in the 3DRA group resulted in a total of (21.04 ± 6.47)loci ablation. Home SBP was significantly lower in both groups at 1 month after RDN treatment compared to baseline(H‐SBP/mmHg: BMRA 149.9 ± 10.59 vs. baseline 168.36 ± 12.76; 3DRA 152.6 ± 14.91 vs. 164.89 ± 12.96, both p < .05). The proportion of people with 24 h ambulatory SBP attainment was significantly higher in both groups and was maintained for 24 months. At each follow‐up time point, there were no differences in home and 24‐h flow SBP, DBP, or Scr between the two groups. There were two cases of severe renal artery complications from implanted vascular stents and one case of femoral artery pseudoaneurysm in the 3DRA group. At follow‐up, 1 (1.9%) patient in the 3DRA group died of unexplained death and 1 (1.9%) patient developed heart failure, and 1 (1.9%) patient in the BMRA group died of unexplained death. Basket multi‐electrode radiofrequency ablation and 3D reconstruction radiofrequency ablation of the renal artery applied to RDN have comparable efficacy in reducing systolic blood pressure.

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Validation of a Novel Renal Denervation System With Cryoablation

Cited by 6 publications

References 32 publications

Device's design and clinical perspectives for resistant hypertension therapy

Device's design and clinical perspectives for resistant hypertension therapy

Device-Based Therapy for Resistant Hypertension: An Up‐to‐Date Review

Efficacy and safety of 3D reconstruction and basket multi‐electrode renal denervation (RDN) for refractory hypertensive patients with chronic kidney disease

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