Victor J M Zeijen1, Lida Feyz1, Rajiv Nannan Panday1, Kevin Veen2, Jorie Versmissen3, Isabella Kardys1, Nicolas M Van Mieghem1, Joost Daemen4. 1. Department of Cardiology, Erasmus University Medical Center, Room Rg-628, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands. 2. Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands. 3. Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, The Netherlands. 4. Department of Cardiology, Erasmus University Medical Center, Room Rg-628, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands. j.daemen@erasmusmc.nl.
Abstract
OBJECTIVES: Renal denervation (RDN) proved to significantly lower blood pressure (BP) at 2-6 months in patients on and off antihypertensive drugs. Given a lack of longer-term follow-up data, our aim was to assess the safety and efficacy of RDN up to five years taking into account antihypertensive drug regimen changes over time. METHODS: In the present single-center study, patients underwent RDN for (therapy resistant) hypertension. Patients underwent protocolized yearly follow-up out to five years. Data were collected on 24-h ambulatory BP and office BP monitoring, renal function, antihypertensive drug regimen, and safety events, including non-invasive renal artery imaging at 6/12 months. Efficacy analyses were performed using linear mixed-effects models. RESULTS: Seventy-two patients with mean age 63.3 ± 9.5 (SD) years (51% female) were included. Median follow-up time was 3.5 years and Clark's Completeness Index was 72%. Baseline ambulatory daytime BP was 146.1/83.7 ± 17.4/12.2 mmHg under a mean number of 4.9 ± 2.7 defined daily doses (DDD). At five years, ambulatory daytime systolic BP as calculated from the mixed model was 120.8 (95% CI 114.2-127.5) mmHg and diastolic BP was 73.3 (95% CI 69.4-77.3) mmHg, implying a reduction of -20.9/-8.3 mmHg as compared to baseline estimates (p < 0.0001). The number of DDDs remained stable over time (p = 0.87). No procedure-related major adverse events resulting in long-term consequences were observed. CONCLUSIONS: The BP-lowering effect of RDN was safely maintained at least five years post-procedure as reflected by a significant decrease in ambulatory daytime BP in the absence of escalating antihypertensive drug therapy over time.
OBJECTIVES: Renal denervation (RDN) proved to significantly lower blood pressure (BP) at 2-6 months in patients on and off antihypertensive drugs. Given a lack of longer-term follow-up data, our aim was to assess the safety and efficacy of RDN up to five years taking into account antihypertensive drug regimen changes over time. METHODS: In the present single-center study, patients underwent RDN for (therapy resistant) hypertension. Patients underwent protocolized yearly follow-up out to five years. Data were collected on 24-h ambulatory BP and office BP monitoring, renal function, antihypertensive drug regimen, and safety events, including non-invasive renal artery imaging at 6/12 months. Efficacy analyses were performed using linear mixed-effects models. RESULTS: Seventy-two patients with mean age 63.3 ± 9.5 (SD) years (51% female) were included. Median follow-up time was 3.5 years and Clark's Completeness Index was 72%. Baseline ambulatory daytime BP was 146.1/83.7 ± 17.4/12.2 mmHg under a mean number of 4.9 ± 2.7 defined daily doses (DDD). At five years, ambulatory daytime systolic BP as calculated from the mixed model was 120.8 (95% CI 114.2-127.5) mmHg and diastolic BP was 73.3 (95% CI 69.4-77.3) mmHg, implying a reduction of -20.9/-8.3 mmHg as compared to baseline estimates (p < 0.0001). The number of DDDs remained stable over time (p = 0.87). No procedure-related major adverse events resulting in long-term consequences were observed. CONCLUSIONS: The BP-lowering effect of RDN was safely maintained at least five years post-procedure as reflected by a significant decrease in ambulatory daytime BP in the absence of escalating antihypertensive drug therapy over time.
Authors: W L Verloop; W R P Agema; C P Allaart; P J Blankestijn; M Khan; M Meuwissen; W M Muijs van de Moer; B J W M Rensing; W Spiering; M Voskuil; P A Doevendans Journal: Neth J Med Date: 2014-11 Impact factor: 1.422
Authors: V J M Zeijen; A A Kroon; B H van den Born; P J Blankestijn; S C A Meijvis; A Nap; E Lipsic; A Elvan; J Versmissen; R J van Geuns; M Voskuil; P A L Tonino; W Spiering; J Deinum; J Daemen Journal: Neth Heart J Date: 2022-08-24 Impact factor: 2.854