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A novel, proof-of-concept radiofrequency renal denervation strategy to improve procedural efficiency: 12-month results from the SPYRAL DYSTAL pilot study. Cardiovascular revascularization medicine : including molecular interventions Sharp, A. S., Kandzari, D. E., Townsend, R. R., Kario, K., Mahfoud, F., Weber, M. A., Schmieder, R. E., Tsioufis, K., Bohm, M., Choi, J. W., Liu, M., DeBruin, V., Lee, D. P. 2024

Abstract

BACKGROUND: Catheter-based renal sympathetic denervation (RDN) reduced blood pressure (BP) in multiple randomized sham-controlled trials of patients with uncontrolled hypertension (HTN). We tested proof-of-concept for a more selective treatment strategy, exclusively targeting these areas to improve the efficiency of the procedure.METHODS: The SPYRAL DYSTAL Pilot study was designed to mirror the SPYRAL HTN-OFF MED Pivotal study, enabling comparison with a propensity score adjusted active-control group. Patients were antihypertensive medication-free for one month before undergoing BP assessment. Those with office BP of 150-180/>90mmHg and with an ambulatory systolic BP of 140-170mmHg were selected to undergo open label treatment, delivering energy only to the distal main renal arteries and first order branches. Patients from DYSTAL were compared with patients who underwent maximized RF RDN treatment in the prior randomized OFF MED trial at 3months. After 3months, patients resumed antihypertensive medications as indicated. Safety and efficacy outcomes were assessed post hoc through 12months.RESULTS: The SPYRAL DYSTAL Pilot study treated 56 HTN patients. Baseline office systolic BP (OSBP) and 24-h ambulatory systolic BP (ASBP) were similar between DYSTAL and OFF MED patient groups. The number of ablations (32.3±8.0 vs 46.6±15.3, p<0.001), procedure time (67±21min vs 99±36min; p<0.001), and contrast volume (173±77cc vs 208±96cc; p=0.014) were significantly lower with the simplified treatment strategy. OSBP and ASBP changes compared with baseline were -9.0 and -1.4mmHg at 3months, -20.3 and-13.9mmHg at 6months, and-20.3 and-16.6mmHg at 12months, respectively. During the medication up-titration phase, BP reductions among DYSTAL patients were similar to reductions observed in OFF MED through 12months, with comparable number of drugs (1.4 and 1.5 medications, respectively (P=NS)). Two adverse events related to guidewire placement were reported.CONCLUSION: In this pilot study, focusing ablation treatment on the distal main and proximal branch renal arteries was performed, resulting in fewer RF lesions, and reduced contrast volume and procedure time. Whether BP reductions are similar between a selective vs. maximized RDN approach requires further prospective study.

View details for DOI 10.1016/j.carrev.2024.04.005

View details for PubMedID 38616460