TCT-580 Initial, Prospective Analysis of Uncontrolled Hypertensive Patients Included in the Global Paradise System (GPS) Registry Outside of the United States

Abstract

Background: The Global Paradise System (GPS) Registry is a real world, all comers, retrospective, and prospective registry being conducted in 9 countries outside of the United States. GPS was designed to assess the long-term safety and effectiveness of ultrasound renal denervation (uRDN) with the Paradise System when used according to its labelling. Method(s): Office blood pressure (BP) measurements were collected from all patients with a subset of patients also collecting home and ambulatory BP. This is the first prospective analysis of the GPS Registry data. Result(s): At the time of analysis, a total of 448 patients were included in the GPS Registry, of which 396 had been treated. Of these, 317 patients, (80%) were prospectively enrolled and 212 met the criteria for uncontrolled hypertension defined as a baseline office systolic (SBP) >= 140 mmHg. Of the 212 uncontrolled hypertensive patients, 137 completed 3 months follow-up and 92 completed 6 months follow-up. The median number of anti-hypertensive medications at baseline for the prospective uncontrolled cohort was 3.0 [0.0, 10.0]. Average age was 57.1 +/- 12.6 yrs, 46% of patients were female and the majority were white, where data was available. Significant co-morbidities included diabetes (25.6%), hyperlipidemia (71.4%), coronary artery disease (31.6%), heart failure (21.4%), and history of hypertensive crisis (24.5%). Mean baseline office BP was 172.4 +/- 23.1/ 99.2 +/- 16.1 mmHg (n=212) which was reduced to 156.5 +/- 25.7/ 91.6 +/- 17.5 (-15.5/-6.6 mmHg, n=137) at 3 months follow-up and further reduced to 150.8 +/- 25.3/ 87.6 +/- 15.1 (-18.4/-9.8 mmHg, n=92) at 6 months follow-up. On average, the number of anti-hypertensive medications remained unchanged over 6 months follow-up. Few adverse events were reported, mainly related to access site complications. Conclusion(s): In summary, early prospective data from the real-world GPS Registry in patients with uncontrolled hypertension, show a substantial blood pressure lowering effect of uRDN at 3- and 6-months follow-up without any safety concerns. Categories: ENDOVASCULAR: Hypertension Therapies and Renal Denervation Copyright © 2025