Is an Abnormal Vascular Response After Renal Sympathetic Denervation Predictive of Permanent Damage? An Unusual Case of Late Renal Artery Stenosis After Energy Delivery

Versaci, Francesco; Trivisonno, Antonio; Olivieri, Carlo; Magri, Geo; Caranci, Fiorella; Prati, Francesco

doi:10.1583/13-4574mr.1

Cited by 13 publications

(6 citation statements)

References 9 publications

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“…Nevertheless, the problems associated with this procedure should not be ignored. Currently, although the number of patients who undergo percutaneous endovascular RDN is limited and the follow-up period is short, some side effects have been reported [15], i.e., lumen stenosis, atrial wall hematoma, intimal tears, intraluminal thrombosis, intima-media thickening [16][17][18][19], etc. Most of these factors may be caused by the direct delivery of RF energy or stimulation of the endothelium by the wire and catheter.…”

Section: Discussionmentioning

confidence: 99%

Laparoscopic-based perivascular renal sympathetic nerve denervation: a feasibility study in a porcine model

Zhao

Yang

et al. 2020

Eur J Med Res

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Background: This study aims to evaluate the effects and safety of laparoscopic-based perivascular renal sympathetic nerve denervation (RDN) in a porcine model fed a high-fat diet. Method: Thirty-six high-fat diet-fed Bama minipigs were randomly divided into an RDN group (n = 18), in which minipigs received laparoscopic-based perivascular RDN, and a sham group (n = 18). All pigs were fed the high-fat diet after the operation to establish a model of obesity-induced hypertension. Bama pigs in the RDN and sham groups were killed at 3 time points [2 days after RDN (n = 6), day 90 (n = 6) and day 180 (n = 6)]. Result: The systolic blood pressure (SBP) and noradrenaline (NE) concentration in the kidney tissue were significantly lower in the RDN group than in the sham group at 2 days (113.83 ± 3.26 mmHg vs 129.67 ± 3.32 mmHg, P = 0.011, and 112.02 ± 17.34 ng/g vs 268.48 ± 20.61 ng/g, P < 0.001, respectively), 90 days (116.83 ± 3.88 mmHg vs 145.00 ± 4.22 mmHg, P = 0.001, respectively) and 180 days (129.33 ± 2.87 mmHg vs 168.57 ± 2.86 mmHg, P < 0.001, and 152.15 ± 16.61 ng/g vs 318.97 ± 24.84 ng/g, P < 0.001, respectively) after the operation. The diastolic blood pressure (DBP) was significantly lower in the RDN group than in sham group at 90 and 180 days after the operation (72.17 ± 2.7 mmHg vs 81.50 ± 2.22 mmHg, P = 0.037, and 76.83 ± 2.75 mmHg vs 86.33 ± 2.22 mmHg P = 0.021, respectively). Based on the pathological evaluation, the renal sympathetic nerve fascicles were successfully disrupted by radiofrequency energy after laparoscopic-based perivascular RDN, but the intima was intact. Tyrosine hydroxylase (TH) expression was decreased, while the expression of the S100 protein was increased in treated renal arteries after RDN. Conclusions: Laparoscopic-based perivascular RDN prevented the occurrence and development of hypertension, and thus it may be an efficient and safe method for controlling blood pressure in an experimental model.

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Section: Discussionmentioning

confidence: 99%

Laparoscopic-based perivascular renal sympathetic nerve denervation: a feasibility study in a porcine model

Zhao

Yang

et al. 2020

Eur J Med Res

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“…Some of the reported complications are: renal artery spasm [85], renal artery stenosis [61,86,87], dissection of the renal artery [7], hematoma in the groin [6], and pseudoaneurysm [6,7] at the femoral access site. Another concern has been kidney function.…”

Section: Safety and Complicationsmentioning

confidence: 99%

Renal denervation

Olsen

Kamper

Svendsen

et al. 2015

European Journal of Internal Medicine

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Initial studies demonstrated that RDN in patients with resistant hypertension was both feasible and safe and indicated that RDN may lead to impressive reductions in BP. However, recent controlled studies question the BP lowering effect of RDN treatment. Large-scale registry data still supports the favorable BP reducing effect of RDN. We suggest that, in the near future, RDN should not be performed outside clinical studies. The degree of denervation between individual operators and between different catheters and techniques used should be clarified. The major challenge ahead is to identify which patients could benefit from RDN, to clarify the lack of an immediate procedural success parameter, and to establish further documentation of overall effect of treatment such as long-term cardiovascular morbidity and mortality.

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“…Up to now, at least 13 cases of significant, de novo renal artery stenosis have been documented 3 to 6 months after RDN performed using four different renal ablation systems [2••, 55–65]. The diagnosis was made following blood pressure increase after an initial decrease [2••, 56–65], renal function degradation [59, 61] and/or repeated pulmonary oedema [61, 63].…”

Section: A Closer Look At Safety Issuesmentioning

confidence: 99%

“…The diagnosis was made following blood pressure increase after an initial decrease [2••, 56–65], renal function degradation [59, 61] and/or repeated pulmonary oedema [61, 63]. Notably, most of these reports were published in 2014, i.e., after the Medtronic announcement that Symplicity HTN-3 had failed to reach its primary endpoint.…”

Section: A Closer Look At Safety Issuesmentioning

confidence: 99%

Renal Denervation after Symplicity HTN-3: An Update

et al. 2014

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After three years of excessive confidence, overoptimistic expectations and performance of 15 to 20,000 renal denervation procedures in Europe, the failure of a single well-designed US trial—Symplicity HTN-3—to meet its primary efficacy endpoint has cast doubt on renal denervation as a whole. The use of a sound methodology, including randomisation and blinded endpoint assessment was enough to see the typical 25–30 mmHg systolic blood pressure decrease observed after renal denervation melt down to less than 3 mmHg, the rest being likely explained by Hawthorne and placebo effects, attenuation of white coat effect, regression to the mean and other physician and patient-related biases. The modest blood pressure benefit directly assignable to renal denervation should be balanced with unresolved safety issues, such as potentially increased risk of renal artery stenosis after the procedure (more than ten cases reported up to now, most of them in 2014), unclear long-term impact on renal function and lack of morbidity–mortality data. Accordingly, there is no doubt that renal denervation is not ready for clinical use. Still, renal denervation is supported by a strong rationale and is occasionally followed by major blood pressure responses in at-risk patients who may otherwise have remained uncontrolled. Upcoming research programmes should focus on identification of those few patients with truly resistant hypertension who may derive a substantial benefit from the technique, within the context of well-designed randomised trials and independent registries. While electrical stimulation of baroreceptors and other interventional treatments of hypertension are already “knocking at the door”, the premature and uncontrolled dissemination of renal denervation should remain an example of what should not be done, and trigger radical changes in evaluation processes of new devices by national and European health authorities.

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Is an Abnormal Vascular Response After Renal Sympathetic Denervation Predictive of Permanent Damage? An Unusual Case of Late Renal Artery Stenosis After Energy Delivery

Abstract: Renal denervation can be complicated by local tissue injury at the ablation sites that could be a possible trigger of late arterial disease.

Cited by 13 publications

References 9 publications

Laparoscopic-based perivascular renal sympathetic nerve denervation: a feasibility study in a porcine model

Laparoscopic-based perivascular renal sympathetic nerve denervation: a feasibility study in a porcine model

Renal denervation

Renal Denervation after Symplicity HTN-3: An Update

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