Background: It is unclear whether renal denervation (RDN) can safely result in blood pressure (BP) reductions in Asian hypertensive patients and whether such reductions would be sustainable. The study is to assess the safety and efficacy of RDN achieved by either main renal artery ablation using the Symplicity Flex catheter or main plus branch renal artery ablations using the Symplicity Spyral catheter in Taiwanese uncontrolled hypertensive patients enrolled in the Global SYMPLICITY Registry (GSR) with 3 years of follow-up.
Methods: The GSR is a prospective, open-label, and all-comer registry to evaluate the safety and effectiveness of RDN in patients with uncontrolled hypertension worldwide.
Results: Among 26 patients enrolled (mean age, 59.1 ± 13.8 years), 8 were treated with the Symplicity Flex catheter, and 18 were treated with the Symplicity Spyral catheter. Baseline office systolic BP was 168.2 ± 19.8 mmHg and diastolic BP was 89.0 ± 14.3 mmHg. Office BP reductions following RDN were sustained throughout the follow-up periods of up to 3 years in the Symplicity Flex group and 2 years in the Symplicity Spyral group. In the Symplicity Flex group, the office systolic BP reductions were 14.9 ± 14.7 mmHg and 29.7 ± 25.9 mmHg at 3 months and 3 years, respectively (both p < 0.05 from baseline). In the Symplicity Spyral group, the office systolic BP reductions were 21.2 ± 28.7 mmHg and 42.4 ± 10.7 mmHg at 3 months and 2 years, respectively (both p < 0.05 from baseline). There were no significant changes in heart rate or antihypertensive medication classes. Three protocol-defined adverse events occurred in 2 patients, including new-onset end-stage renal disease, stroke, and hospitalization for new-onset heart failure.
Conclusions: Given the susceptibility of Asian populations to hypertension, RDN, as a safe antihypertensive procedure with long-lasting BP-lowering effects, could reliably serve as an alternative or complementary BP-lowering strategy for patients with uncontrolled hypertension in Taiwan and other Asian countries.
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| http://dx.doi.org/10.6515/ACS.201911_35(6).20190826A | DOI Listing |
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Article Synopsis
- The SYMPLICITY HTN-3 trial aimed to evaluate the safety and effectiveness of the Symplicity system for treating patients with uncontrolled hypertension, initially showing safety after 6 months but not efficacy.
- Conducted across 88 centers in the USA, the trial involved adults aged 18-80 with treatment-resistant hypertension and compared outcomes of renal artery denervation versus a sham control over a follow-up period of 36 months.
- The final report details long-term blood pressure changes, analyzing results from participants in both the renal denervation group and those who crossed over from the sham group after the 6-month mark.
Long-term outcomes after renal denervation in an Asian population: results from the Global SYMPLICITY Registry in South Korea (GSR Korea).
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September 2021
Department of Internal Medicine, Cardiology Division, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.
The objective of this work was to investigate the long-term safety and efficacy of renal denervation in Korean patients from the Global SYMPLICITY Registry (GSR). GSR Korea is a substudy of GSR with additional inclusion and exclusion criteria compared to GSR, including inclusion criteria of office systolic blood pressure ≥160 mmHg, or ≥150 mmHg for type 2 diabetes patients, while receiving 3 or more antihypertensive medications without changes for 2 weeks prior to enrollment. Renal denervation was performed using a Symplicity Flex catheter for ablation in the main renal arteries.
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