Hypertension urgencies in the SPYRAL HTN-OFF MED Pivotal trial

Weber, Michael A.; Schmieder, Roland E.; Kandzari, David E.; Townsend, Raymond R.; Mahfoud, Felix; Tsioufis, Κonstantinos; Kario, Kazuomi; Pocock, Stuart J.; Tatakis, Fotis; Ewen, Sebastian; Choi, James W.; East, Cara; Lee, David P.; Ma, Adrian; Cohen, Debbie L.; Wilensky, Robert L.; Devireddy, Chandan; Lea, Janice P.; Schmid, Axel; Fahy, Martin; Böhm, Michael

doi:10.1007/s00392-022-02064-5

Cited by 9 publications

(1 citation statement)

References 15 publications

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“…However, it is crucial to note that this trial used the first-generation ablation catheter with a single electrode, which did not allow for a verification of contact between the electrode and the arterial wall. Subsequent clinical studies utilizing the second-generation devices, such as the DENERHTN trial [ 72 ], the Spyral HTN-ON MED trial [ 73 , 74 ], and the Spyral HTN-OFF MED trial [ 75 , 76 ], have shown promising results with a significant blood pressure reduction. These second-generation devices have offered more advanced features and improvements in the ablation catheter technology.…”

Section: Unresolved Cardinal Questionsmentioning

confidence: 99%

Emerging Role of Renal Sympathetic Denervation as an Adjunct Therapy to Atrial Fibrillation Ablation

Akrawinthawong,

Yamada

2024

Rev. Cardiovasc. Med.

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The central anatomical locus in the context of atrial fibrillation (AF) ablation has been the pulmonary veins. Despite the attainment of a modest long-term success rate through pulmonary vein isolation (PVI), the pursuit of achieving a therapeutic efficacy nearing a definitive cure has spurred an investigation into alternative strategies and anatomical loci beyond the pulmonary veins. Despite extensive exploration, none of these alternative targets have succeeded in establishing themselves as routine ablation sites comparable to the pulmonary veins. Consequently, there exists an imperative for further inquiry and refinement of ablation strategies to propel advancements within the domain of AF ablation, thereby augmenting patient outcomes. Simultaneously, the examination of the autonomic system’s role in AF pathophysiology introduces an additional ablation target aimed at rectifying sympathovagal imbalance. This discourse presents a contemporary review of renal denervation (RDN) as an emergent and auspicious technique poised to complement PVI, thereby contributing substantively to the augmentation of long-term success within the ambit of AF rhythm-control strategies.

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Section: Unresolved Cardinal Questionsmentioning

confidence: 99%

Emerging Role of Renal Sympathetic Denervation as an Adjunct Therapy to Atrial Fibrillation Ablation

Akrawinthawong,

Yamada

2024

Rev. Cardiovasc. Med.

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Real-world experience with ultrasound renal denervation utilizing home blood pressure monitoring: the Global Paradise System registry study design

Mahfoud,

Azizi,

Daemen

et al. 2023

Clin Res Cardiol

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Background Hypertension is a major public health issue due to its association with cardiovascular disease risk. Despite the availability of effective antihypertensive drugs, rates of blood pressure (BP) control remain suboptimal. Renal denervation (RDN) has emerged as an effective non-pharmacological, device-based treatment option for patients with hypertension. The multicenter, single-arm, observational Global Paradise™ System (GPS) registry has been designed to examine the long-term safety and effectiveness of ultrasound RDN (uRDN) with the Paradise System in a large population of patients with hypertension. Methods The study aims to enroll up to 3000 patients undergoing uRDN in routine clinical practice. Patients will be recruited over a 4-year period and followed for 5 years (at 3, 6, and 12 months after the uRDN procedure and annually thereafter). Standardized home BP measurements will be taken every 3 months with automatic upload to the cloud. Office and ambulatory BP and adverse events will be collected as per routine clinical practice. Quality-of-Life questionnaires will be used to capture patient-reported outcomes. Conclusions This observational registry will provide real-world information on the safety and effectiveness of uRDN in a large population of patients treated during routine clinical practice, and also allow for a better understanding of responses in prespecified subgroups. The focus on home BP in this registry is expected to improve completeness of long-term follow-up and provide unique insights into BP over time. Graphical abstract Global Paradise System registry study design. ABP, ambulatory blood pressure; BP, blood pressure; FU, follow-up; M, month; OBP, office blood pressure.

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Ultra-long-term efficacy and safety of catheter-based renal denervation in resistant hypertension: 10-year follow-up outcomes

Al Ghorani,

Kulenthiran,

Lauder

et al. 2024

Clin Res Cardiol

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Background Randomized sham-controlled trials have confirmed the efficacy and safety of catheter-based renal denervation in hypertension. Data on the very long-term effects of renal denervation are scarce. Aims This study evaluates the 10-year safety and efficacy of renal denervation in resistant hypertension. Methods This prospective single-center study included patients with resistant hypertension undergoing radio-frequency renal denervation between 2010 and 2012. Office blood pressure, 24-h ambulatory blood pressure, antihypertensive medication, color duplex sonography, and renal function were assessed after 1-, 2- and 10-years. Results Thirty-nine patients completed the 10-year follow-up (mean follow-up duration 9.4 ± 0.7 years). Baseline office and 24-h ambulatory systolic blood pressure were 164 ± 23 mmHg and 153 ± 16 mmHg, respectively. After 10 years, 24-h ambulatory and office systolic blood pressure were reduced by 16 ± 17 mmHg (P < 0.001) and 14 ± 23 mmHg (P = 0.001), respectively. The number of antihypertensive drugs remained unchanged from 4.9 ± 1.4 to 4.5 ± 1.2 drugs (P = 0.087). The estimated glomerular filtration rate declined within the expected range from 69 (95% CI 63 to 74) to 60 mL/min/1.73m2 (95% CI 53 to 68; P < 0.001) through 10-year follow-up. Three renal artery interventions were documented for progression of pre-existing renal artery stenosis in two patients and one patient with new-onset renal artery stenosis. No other adverse events were observed during the follow-up. Conclusion Renal denervation was safe and sustainedly reduced ambulatory and office blood pressure out to 10 years in patients with resistant hypertension. Graphical abstract Left panel, Change in 24-h and office SBP. Right panel, eGFR over time. SBP, systolic blood pressure; eGFR, estimated glomerular filtration rate.

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Hypertension urgencies in the SPYRAL HTN-OFF MED Pivotal trial

Cited by 9 publications

References 15 publications

Emerging Role of Renal Sympathetic Denervation as an Adjunct Therapy to Atrial Fibrillation Ablation

Emerging Role of Renal Sympathetic Denervation as an Adjunct Therapy to Atrial Fibrillation Ablation

Real-world experience with ultrasound renal denervation utilizing home blood pressure monitoring: the Global Paradise System registry study design

Ultra-long-term efficacy and safety of catheter-based renal denervation in resistant hypertension: 10-year follow-up outcomes

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