Outcomes Following Radiofrequency Renal Denervation According to Antihypertensive Medications: Subgroup Analysis of the Global SYMPLICITY Registry DEFINE

BACKGROUND: The Global SYMPLICITY Registry DEFINE investigates radiofrequency renal denervation (RDN) in a broad range of patients with hypertension. We evaluated whether the number or type of antihypertensive medications were associated with increased long-term blood pressure (BP) reductions and cardiovascular outcomes following radiofrequency RDN. METHODS: Patients underwent radiofrequency RDN and were categorized by baseline number (0-3 and ≥4) and different combinations of medication classes. BP changes were compared between groups through 36 months. Individual and composite major adverse cardiovascular events were analyzed. RESULTS: Of 2746 evaluable patients, 18% were prescribed 0 to 3 and 82% prescribed ≥4 classes. At 36 months, office systolic BP significantly decreased (P<0.0001) by -19.0±28.3 and -16.2±28.6 mm Hg in the 0 to 3 and ≥4 class groups, respectively. Twenty-four-hour mean systolic BP significantly decreased (P<0.0001) by -10.7±19.7 and -8.9±20.5 mm Hg, respectively. BP reduction was similar between the medication subgroups. Antihypertensive medication classes decreased from 4.6±1.4 to 4.3±1.5 (P<0.0001). Most decreased (31%) or had no changes (47%) to the number of medications, while 22% increased. The number of baseline antihypertensive medication classes was inversely related to the change in prescribed classes at 36 months (P<0.001). Cardiovascular event rates were generally low. More patients in the ≥4 compared with 0 to 3 medication classes had myocardial infarction at 36 months (2.8% versus 0.3%; P=0.009). CONCLUSIONS: Radiofrequency RDN reduced BP safely through 36 months, independent of the number and type of baseline antihypertensive medication classes. More patients decreased than increased their number of medications. Radiofrequency RDN is a safe and effective adjunctive therapy regardless of antihypertensive medication regimen. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01534299

Cardiovascular Risk Reduction After Renal Denervation According to Time in Therapeutic Systolic Blood Pressure Range

Background: Renal denervation (RDN) has been shown to lower blood pressure (BP), but its effects on cardiovascular events have only been preliminarily evaluated. Time in therapeutic range (TTR) of BP is associated with cardiovascular events. Objectives: This study sought to assess the impact of catheter-based RDN on TTR and its association with cardiovascular outcomes in the GSR (Global SYMPLICITY Registry). Methods: Patients with uncontrolled hypertension were enrolled and treated with radiofrequency RDN. Office and ambulatory systolic blood pressure (OSBP and ASBP) were measured at 3, 6, 12, 24, and 36 months postprocedure and used to derive TTR. TTR through 6 months was assessed as a predictor of cardiovascular events from 6 to 36 months using a Cox proportional hazard regression model. Results: As of March 1, 2022, 3,077 patients were enrolled: 42.2% were female; mean age was 60.5 ± 12.2 years; baseline OSBP was 165.6 ± 24.8 mm Hg; and baseline ASBP was 154.3 ± 18.7 mm Hg. Patients were prescribed 4.9 ± 1.7 antihypertensive medications at baseline and 4.8 ± 1.9 at 36 months. At 36 months, mean changes were −16.7 ± 28.4 and −9.0 ± 20.2 mm Hg for OSBP and ASBP, respectively. TTR through 6 months was 30.6%. A 10% increase in TTR after RDN through 6 months was associated with significant risk reductions from 6 to 36 months of 15% for major adverse cardiovascular events (P < 0.001), 11% cardiovascular death (P = 0.010), 15% myocardial infarction (P = 0.023), and 23% stroke (P < 0.001). Conclusions: There were sustained BP reductions and higher TTR through 36 months after RDN. A 10% increase in TTR through 6 months was associated with significant risk reductions in major cardiovascular events from 6 to 36 months. (Global SYMPLICITY Registry [GSR] DEFINE; NCT01534299

Impact of COVID-19 Pandemic on TAVR Activity: A Worldwide Registry

Background: The COVID-19 pandemic had a considerable impact on the provision of structural heart intervention worldwide. Our objectives were: 1) to assess the impact of the COVID-19 pandemic on transcatheter aortic valve replacement (TAVR) activity globally; and 2) to determine the differences in the impact according to geographic region and the demographic, development, and economic status of diverse international health care systems. Methods: We developed a multinational registry of global TAVR activity and invited individual TAVR sites to submit TAVR implant data before and during the COVID-19 pandemic. Specifically, the number of TAVR procedures performed monthly from January 2019 to December 2021 was collected. The adaptive measures to maintain TAVR activity by each site were recorded, as was a variety of indices relating to type of health care system and national economic indices. The primary subject of interest was the impact on TAVR activity during each of the pandemic waves (2020 and 2021) compared with the same period pre–COVID-19 (2019). Results: Data were received from 130 centers from 61 countries, with 14 subcontinents and 5 continents participating in the study. Overall, TAVR activity increased by 16.7% (2,337 procedures) between 2018 and 2019 (ie, before the pandemic), but between 2019 and 2020 (ie, first year of the pandemic), there was no significant growth (–0.1%; –10 procedures). In contrast, activity again increased by 18.9% (3,085 procedures) between 2020 and 2021 (ie, second year of the pandemic). During the first pandemic wave, there was a reduction of 18.9% (945 procedures) in TAVR activity among participating sites, while during the second and third waves, there was an increase of 6.7% (489 procedures) and 15.9% (1,042 procedures), respectively. Further analysis and results of this study are ongoing and will be available at the time of the congress. Conclusion: The COVID-19 pandemic initially led to a reduction in the number of patients undergoing TAVR worldwide, although health care systems subsequently adapted, and the number of TAVR recipients continued to grow in subsequent COVID-19 pandemic waves. Categories: STRUCTURAL: Valvular Disease: Aorti

Pre-discharge 18F-Flourodeoxyglucose uptake pattern following transcatheter aortic-valve replacement and adverse prognostic features in aortic stenosis

18F-Flourodeoxyglucose positron emission tomography/computed tomography (18F-FDG-PET/CT) has been shown to be of utility in transcatheter aortic valve replacement (TAVR) patients with suspected prosthetic valve endocarditis. In the present study, we sought to analyze the relationship between 18F-FDG-PET/CT performed before discharge in TAVR patients and adverse prognostic features of aortic stenosis. We analyzed the association between 18F-FDG-PET/CT uptake pattern and degree of left ventricular mass index, aortic root dilatation, and aortic leaflet calcification extent. This is the first study to demonstrate that pre-discharge 18F-FDG-PET/CT in patients undergoing TAVR shows a significant negative correlation between 18F-FDG uptake pattern and adverse prognostic features

Native aortic leaflets and permanent pacemaker implantation risk following balloon-expandable transcatheter aortic valve implantation

Objective: Permanent pacemaker implantation (PPI) risk is higher following transcatheter aortic valve implantation (TAVI) than surgical valve replacement. Native aortic leaflets are retained in patients undergoing TAVI, unlike in surgical valve replacement. Whether the retained leaflets influence PPI risk because of their proximity to the conduction system is unknown. The study sought to determine the association between infra-annular extension of native right coronary cusp/noncoronary cusp (RCC/NCC) post balloon-expandable TAVI and PPI risk. Methods: We performed a retrospective analysis of 190 patients undergoing balloon-expandable TAVI at a single center. Manifestation of infra-annular extension of RCC/NCC was considered to be present when part of leaflet extended below aortic–annular plane on post-implantation aortic-root angiography. Results: Infra-annular extension of RCC/NCC was observed in 33 patients (17.37%). PPI incidence post-TAVI was higher in patients with infra-annular extension of RCC/NCC than in those without (36.36% versus 8.92%, relative-risk: 4.08, p˂0.0001). On logistic-regression analysis, preexisting right bundle-branch block (RBBB) (odds-ratio: 12.73, 95% confidence-interval: 2.16–74.93, p = 0.005), and infra-annular extension of RCC/NCC (odds-ratio: 5.63, 95% confidence-interval: 2.17–14.58, p < 0.0001) were independently associated with PPI risk. Preexisting RBBB (φ = +0.25, p = 0.001) and infra-annular extension of RCC/NCC (φ = +0.30, p < 0.0001) showed a positive-correlation with PPI risk. Infra-annular extension of RCC/NCC was a significant predictor of PPI risk on receiver-operating-characteristic curve analysis (area under-the-curve 0.67; 95% confidence-interval: 0.54–0.79, p = 0.006). Conclusion: The retained native aortic leaflets play a significant role in PPI risk following balloon-expandable TAVI. Infra-annular extension of RCC/NCC is a novel predictor, and is associated with a four-fold higher risk of PPI

Outcomes Following Radiofrequency Renal Denervation According to Antihypertensive Medications: Subgroup Analysis of the Global SYMPLICITY Registry DEFINE

BACKGROUND: The Global SYMPLICITY Registry DEFINE (Denervation Findings in Real World) investigates radiofrequency renal denervation (RDN) in a broad range of patients with hypertension. We evaluated whether the number or type of antihypertensive medications were associated with increased long-term blood pressure (BP) reductions and cardiovascular outcomes following radiofrequency RDN.METHODS: Patients underwent radiofrequency RDN and were categorized by baseline number (0-3 and &gt;= 4) and different combinations of medication classes. BP changes were compared between groups through 36 months. Individual and composite major adverse cardiovascular events were analyzed.RESULTS: Of 2746 evaluable patients, 18% were prescribed 0 to 3 and 82% prescribed &gt;= 4 classes. At 36 months, office systolic BP significantly decreased (P&lt;0.0001) by -19.0 +/- 28.3 and -16.2 +/- 28.6 mm Hg in the 0 to 3 and =4 class groups, respectively. Twenty-four-hour mean systolic BP significantly decreased (P&lt;0.0001) by -10.7 +/- 19.7 and -8.9 +/- 20.5 mm Hg, respectively. BP reduction was similar between the medication subgroups. Antihypertensive medication classes decreased from 4.6 +/- 1.4 to 4.3 +/- 1.5 (P&lt;0.0001). Most decreased (31%) or had no changes (47%) to the number of medications, while 22% increased. The number of baseline antihypertensive medication classes was inversely related to the change in prescribed classes at 36 months (P&lt;0.001). Cardiovascular event rates were generally low. More patients in the &gt;= 4 compared with 0 to 3 medication classes had myocardial infarction at 36 months (2.8% versus 0.3%; P=0.009).CONCLUSIONS: Radiofrequency RDN reduced BP safely through 36 months, independent of the number and type of baseline antihypertensive medication classes. More patients decreased than increased their number of medications. Radiofrequency RDN is a safe and effective adjunctive therapy regardless of antihypertensive medication regimen.REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01534299

Cardiovascular Risk Reduction After Renal Denervation According to Time in Therapeutic Systolic Blood Pressure Range

BACKGROUND Renal denervation (RDN) has been shown to lower blood pressure (BP), but its effects on cardiovascular events have only been preliminarily evaluated. Time in therapeutic range (TTR) of BP is associated with cardiovascular events.OBJECTIVES This study sought to assess the impact of catheter-based RDN on TTR and its association with cardiovascular outcomes in the GSR (Global SYMPLICITY Registry).METHODS Patients with uncontrolled hypertension were enrolled and treated with radiofrequency RDN. Office and ambulatory systolic blood pressure (OSBP and ASBP) were measured at 3, 6, 12, 24, and 36 months postprocedure and used to derive TTR. TTR through 6 months was assessed as a predictor of cardiovascular events from 6 to 36 months using a Cox proportional hazard regression model.RESULTS As of March 1, 2022, 3,077 patients were enrolled: 42.2% were female; mean age was 60.5 +/- 12.2 years; baseline OSBP was 165.6 +/- 24.8 mm Hg; and baseline ASBP was 154.3 +/- 18.7 mm Hg. Patients were prescribed 4.9 +/- 1.7 antihypertensive medications at baseline and 4.8 +/- 1.9 at 36 months. At 36 months, mean changes were -16.7 +/- 28.4 and -9.0 +/- 20.2 mm Hg for OSBP and ASBP, respectively. TTR through 6 months was 30.6%. A 10% increase in TTR after RDN through 6 months was associated with significant risk reductions from 6 to 36 months of 15% for major adverse cardiovascular events (P &lt; 0.001), 11% cardiovascular death (P = 0.010), 15% myocardial infarction (P = 0.023), and 23% stroke (P &lt; 0.001).CONCLUSIONS There were sustained BP reductions and higher TTR through 36 months after RDN. A 10% increase in TTR through 6 months was associated with significant risk reductions in major cardiovascular events from 6 to 36 months. (Global SYMPLICITY Registry [GSR] DEFINE; NCT01534299) (c) 2022 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation

Impact of the COVID-19 Pandemic on Global TAVR Activity:The COVID-TAVI Study

Background: The COVID-19 pandemic adversely affected health care systems. Patients in need of transcatheter aortic valve replacement (TAVR) are especially susceptible to treatment delays. Objectives: This study sought to evaluate the impact of the COVID-19 pandemic on global TAVR activity. Methods: This international registry reported monthly TAVR case volume in participating institutions prior to and during the COVID-19 pandemic (January 2018 to December 2021). Hospital-level information on public vs private, urban vs rural, and TAVR volume was collected, as was country-level information on socioeconomic status, COVID-19 incidence, and governmental public health responses. Results: We included 130 centers from 61 countries, including 65,980 TAVR procedures. The first and second pandemic waves were associated with a significant reduction of 15% (P &lt; 0.001) and 7% (P &lt; 0.001) in monthly TAVR case volume, respectively, compared with the prepandemic period. The third pandemic wave was not associated with reduced TAVR activity. A greater reduction in TAVR activity was observed in Africa (−52%; P = 0.001), Central-South America (−33%; P &lt; 0.001), and Asia (−29%; P &lt; 0.001). Private hospitals (P = 0.005), urban areas (P = 0.011), low-volume centers (P = 0.002), countries with lower development (P &lt; 0.001) and economic status (P &lt; 0.001), higher COVID-19 incidence (P &lt; 0.001), and more stringent public health restrictions (P &lt; 0.001) experienced a greater reduction in TAVR activity. Conclusions: TAVR procedural volume declined substantially during the first and second waves of the COVID-19 pandemic, especially in Africa, Central-South America, and Asia. National socioeconomic status, COVID-19 incidence, and public health responses were associated with treatment delays. This information should inform public health policy in case of future global health crises.</p