Search

Your search keyword '"Fahy, M"' showing total 459 results
Start Over Author "Fahy, M"

Refine your results

more »

more »

more »

more »

more »
459 results on '"Fahy, M"'

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

Author

Mahfoud, F, Mancia, G, Schmieder, R, Ruilope, L, Narkiewicz, K, Schlaich, M, Williams, B, Ribichini, F, Weil, J, Almerri, K, Sharif, F, Lauder, L, Wanten, M, Fahy, M, Böhm, M, Mahfoud F., Mancia G., Schmieder R. E., Ruilope L., Narkiewicz K., Schlaich M., Williams B., Ribichini F., Weil J., Almerri K., Sharif F., Lauder L., Wanten M., Fahy M., Böhm M., Mahfoud, F, Mancia, G, Schmieder, R, Ruilope, L, Narkiewicz, K, Schlaich, M, Williams, B, Ribichini, F, Weil, J, Almerri, K, Sharif, F, Lauder, L, Wanten, M, Fahy, M, Böhm, M, Mahfoud F., Mancia G., Schmieder R. E., Ruilope L., Narkiewicz K., Schlaich M., Williams B., Ribichini F., Weil J., Almerri K., Sharif F., Lauder L., Wanten M., Fahy M., and Böhm M.

Abstract

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 ≥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; Uniqu

Published
2023

4. Contemporary results from the PelvEx collaborative: improvements in surgical outcomes for locally advanced and recurrent rectal cancer.

Author

Fahy, M, Kelly, ME, Abecasis, N, Akhtar, SN, Akiyoshi, T, Alvarez‐Gallego, M, Andric, MD, Arteaga‐Asensio, P, Assi, H, Austin, KK, Ayub, B, Aytac, E, Bacalbasa, N, Balescu, I, Baransi, S, Baseckas, G, Bedford, MR, Berg, P, Berle, M, and Bloemen, JG

Subjects
*RECTAL cancer, *RECTAL surgery, *PELVIC exenteration, *SURGICAL margin, *EXENTERATION, *SURVIVAL rate
Abstract

Aim: The PelvEx Collaborative collates global data on outcomes following exenterative surgery for locally advanced and locally recurrent rectal cancer (LARC and LRRC, respectively). The aim of this study is to report contemporary data from within the collaborative and benchmark it against previous PelvEx publications. Method: Anonymized data from 45 units that performed pelvic exenteration for LARC or LRRC between 2017 and 2021 were reviewed. The primary endpoints were surgical outcomes, including resection margin status, radicality of surgery, rates of reconstruction and associated morbidity and/or mortality. Results: Of 2186 patients who underwent an exenteration for either LARC or LRRC, 1386 (63.4%) had LARC and 800 (36.6%) had LRRC. The proportion of males to females was 1232:954. Median age was 62 years (interquartile range 52–71 years) compared with a median age of 63 in both historical LARC and LRRC cohorts. Compared with the original reported PelvEx data (2004–2014), there has been an increase in negative margin (R0) rates from 79.8% to 84.8% and from 55.4% to 71.7% in the LARC and LRRC cohorts, respectively. Bone resection and flap reconstruction rates have increased accordingly in both cohorts (8.2%–19.6% and 22.6%–32% for LARC and 20.3%–41.9% and 17.4%–32.1% in LRRC, respectively). Despite this, major morbidity has not increased. Conclusion: In the modern era, patients undergoing pelvic exenteration for advanced rectal cancer are undergoing more radical surgery and are more likely to achieve a negative resection margin (R0) with no increase in major morbidity. [ABSTRACT FROM AUTHOR]

Published
2024
Full Text
View/download PDF

6. 82 Needs of stroke survivors after acute stroke and early supported discharge (ESD), at hospital discharge, and at 3- and 6-months

Author

O'Callaghan, G, primary, Fahy, M, additional, O'Meara, S, additional, Chawke, M, additional, Waldron, E, additional, Corry, M, additional, Gallagher, S, additional, Coyne, C, additional, Lynch, J, additional, Kennedy, E, additional, Walsh, T, additional, Cronin, H, additional, Hannon, N, additional, Fallon, C, additional, Williams, D, additional, Langorne, P, additional, Galvin, R, additional, and Horgan, F, additional

Published
2023
Full Text
View/download PDF

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

Author

Mahfoud, F, Mancia, G, Schmieder, R, Ruilope, L, Narkiewicz, K, Schlaich, M, Williams, B, Ribichini, F, Weil, J, Kao, H, Rodriguez-Leor, O, Noory, E, Ong, T, Unterseeh, T, de Araujo Goncalves, P, Zirlik, A, Almerri, K, Sharif, F, Lauder, L, Wanten, M, Fahy, M, Bohm, M, Mahfoud F., Mancia G., Schmieder R. E., Ruilope L., Narkiewicz K., Schlaich M., Williams B., Ribichini F., Weil J., Kao H. -L., Rodriguez-Leor O., Noory E., Ong T. K., Unterseeh T., de Araujo Goncalves P., Zirlik A., Almerri K., Sharif F., Lauder L., Wanten M., Fahy M., Bohm M., Mahfoud, F, Mancia, G, Schmieder, R, Ruilope, L, Narkiewicz, K, Schlaich, M, Williams, B, Ribichini, F, Weil, J, Kao, H, Rodriguez-Leor, O, Noory, E, Ong, T, Unterseeh, T, de Araujo Goncalves, P, Zirlik, A, Almerri, K, Sharif, F, Lauder, L, Wanten, M, Fahy, M, Bohm, M, Mahfoud F., Mancia G., Schmieder R. E., Ruilope L., Narkiewicz K., Schlaich M., Williams B., Ribichini F., Weil J., Kao H. -L., Rodriguez-Leor O., Noory E., Ong T. K., Unterseeh T., de Araujo Goncalves P., Zirlik A., Almerri K., Sharif F., Lauder L., Wanten M., Fahy M., and Bohm M.

Abstract

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)

Published
2022

8. Renal denervation in patients with versus without chronic kidney disease: Results from the Global SYMPLICITY Registry with follow-up data of 3 years

Author

Ott, C, Mahfoud, F, Mancia, G, Narkiewicz, K, Ruilope, L, Fahy, M, Schlaich, M, Bohm, M, Schmieder, R, Ott C., Mahfoud F., Mancia G., Narkiewicz K., Ruilope L. M., Fahy M., Schlaich M. P., Bohm M., Schmieder R. E., Ott, C, Mahfoud, F, Mancia, G, Narkiewicz, K, Ruilope, L, Fahy, M, Schlaich, M, Bohm, M, Schmieder, R, Ott C., Mahfoud F., Mancia G., Narkiewicz K., Ruilope L. M., Fahy M., Schlaich M. P., Bohm M., and Schmieder R. E.

Abstract

Background: Activity of the sympathetic nervous system is increased in patients with hypertension and chronic kidney disease (CKD). Here we compare short-and long-term blood pressure (BP)-lowering effects of renal denervation (RDN) between hypertensive patients with or without CKD in the Global SYMPLICITY Registry. Methods: Office and 24-h ambulatory BP (ABP) were assessed at prespecified time points after RDN. The presence of CKD was defined according to the estimated glomerular filtration rate (eGFR) and enrolled patients were stratified based on the presence (n = 475, eGFR <60 mL/min/1.73 m2) or absence (n = 1505, eGFR ≥60mL/min/1.73 m2) of CKD. Results: Patients with CKD were older (P < 0.001) and were prescribed more antihypertensive medications (P < 0.001). eGFR decline per year was not significantly different between groups after the first year. Office and 24-h ABP were significantly reduced from baseline at all time points after RDN in both groups (all P < 0.001). After adjusting for baseline data, patients without CKD had a greater reduction in office systolic BP (-17.3 ± 28.3 versus-11.7 ± 29.9 mmHg; P = 0.009) but not diastolic BP at 36 months compared with those with CKD. Similar BP and eGFR results were found when the analysis was limited to patients with both baseline and 36-month BP data available. There was no difference in the safety profile of the RDN procedure between groups. Conclusions: After adjusting for baseline data, 24-h systolic and diastolic ABP reduction were similar in patients with and without CKD after RDN, whereas office systolic but not diastolic BP was reduced less in patients with CKD. We conclude that RDN is an effective antihypertensive treatment option in CKD patients.

Published
2022

9. Clinical event reductions in high-risk patients after renal denervation projected from the global SYMPLICITY registry

Author

Schmieder, R, Mahfoud, F, Mancia, G, Narkiewicz, K, Ruilope, L, Hutton, D, Cao, K, Hettrick, D, Fahy, M, Schlaich, M, Böhm, M, Pietzsch, J, Schmieder, RE, Hettrick, DA, Schlaich, MP, Pietzsch, JB, Schmieder, R, Mahfoud, F, Mancia, G, Narkiewicz, K, Ruilope, L, Hutton, D, Cao, K, Hettrick, D, Fahy, M, Schlaich, M, Böhm, M, Pietzsch, J, Schmieder, RE, Hettrick, DA, Schlaich, MP, and Pietzsch, JB

Abstract

Aims: Renal denervation has been shown to lower blood pressure in sham-controlled trials and represents a device-based treatment option for hypertension. We sought to project clinical event reductions after radiofrequency renal denervation using a novel modelling approach. Methods and results: The Global SYMPLICITY Registry is a global, prospective all-comer registry to evaluate safety and efficacy after renal denervation. For this analysis, change in office systolic blood pressure from baseline was calculated from reported follow-up in the Global SYMPLICITY Registry. Relative risks for death and other cardiovascular events as well as numbers needed to treat for event avoidance were obtained for the respective blood pressure reductions based on previously reported meta-regression analyses for the full cohort and high-risk subgroups including type 2 diabetes, chronic kidney disease, resistant hypertension, and high basal cardiovascular risk. Average baseline office systolic blood pressure and reduction estimates for the full cohort (N = 2651) were 166±25 and -14.8 ± 0.4 mmHg, respectively. Mean reductions in blood pressure ranged from -11.0 - 21.8 mmHg for the studied high-risk subgroups. Projected relative risks ranged from 0.57 for stroke in the resistant hypertension cohort to 0.92 for death in the diabetes cohort. Significant absolute reductions in major adverse cardiovascular events over 3 years compared with the projected control (8.6 ± 0.7% observed vs. 11.7 ± 0.9% for projected control; P < 0.01) were primarily due to reduced stroke incidence. The robustness of findings was confirmed in sensitivity and scenario analyses. Conclusion: Model-based projections suggest radiofrequency renal denervation for patients with uncontrolled hypertension adds considerable clinical benefit across a spectrum of different cohort characteristics.

Published
2023

11. Changes in blood pressure after catheter-based renal denervation in South Africa

Author

Ebrahim, I, Ntsekhe, M, Rayner, B, Fahy, M, Mancia, G, Böhm, M, Ebrahim, IO, Ebrahim, I, Ntsekhe, M, Rayner, B, Fahy, M, Mancia, G, Böhm, M, and Ebrahim, IO

Abstract

Background: Renal denervation (RDN) is an interventional treatment for patients with uncontrolled hypertension. The all-comer, world-wide registry designed to assess the safety and efficacy of RDN. We evaluated the outcomes in South African patients in the GSR over 12 months. Methods: Eligible patients with hypertension had a daytime mean blood pressure (BP) > 135/85 mmHg or night-time mean BP > 120/70 mmHg. Office and 24-hour ambulatory systolic BP reduction and adverse events over 12 months were Results: South African patients (n = 36) in the GSR had a mean age of 54.4 & PLUSMN; 9.9 years with a median of four prescribed patients were consistent with world-wide GSR results.

Published
2023

16. Making it work: a qualitative study of the work-care reconciliation strategies adopted by family carers in Ireland to sustain their caring role.

Author

Lafferty, A., Phillips, D., Fealy, G., Paul, G., Duffy, C., Dowling-Hetherington, L., Fahy, M., Moloney, B., and Kroll, T.

Subjects
CAREGIVERS, ROLE conflict, QUALITATIVE research, THEMATIC analysis, FAMILIES, SEMI-structured interviews
Abstract

While work-care reconciliation strategies can benefit family carers, employers, wider society and the economy, juggling family caregiving responsibilities with paid employment can lead to role strain. Family carers frequently find themselves engaged in role decisions and role negotiations and being faced with decisions to alter their work commitments in order to fulfil their caregiving responsibilities. The purpose of this study was to explore family carers' experiences of modifying work arrangements to accommodate caregiving responsibilities for an ill or dependant family member. Ten face-to-face, semi-structured interviews were conducted with family carers in Ireland, which were audio-recorded, transcribed verbatim and analysed using thematic content analysis. The findings highlighted the value placed on work by family carers, but despite this, the caring role always took precedence over the employee role. Family carers adopted a combination of strategies, and where possible, carved out a carer-friendly career for themselves. The findings also revealed the key triggers for work alterations and the sacrifices made by family carers. It is important that family carers are supported by employers to successfully balance work with caregiving responsibilities and that an array of work options are available to them, so that they can make better-informed choices regarding work-care reconciliation. [ABSTRACT FROM AUTHOR]

Published
2023
Full Text
View/download PDF

17. Renal Denervation in High-Risk Patients With Hypertension

Author

Mahfoud, F, Mancia, G, Schmieder, R, Narkiewicz, K, Ruilope, L, Schlaich, M, Whitbourn, R, Zirlik, A, Zeller, T, Stawowy, P, Cohen, S, Fahy, M, Bohm, M, Mahfoud F., Mancia G., Schmieder R., Narkiewicz K., Ruilope L., Schlaich M., Whitbourn R., Zirlik A., Zeller T., Stawowy P., Cohen S. A., Fahy M., Bohm M., Mahfoud, F, Mancia, G, Schmieder, R, Narkiewicz, K, Ruilope, L, Schlaich, M, Whitbourn, R, Zirlik, A, Zeller, T, Stawowy, P, Cohen, S, Fahy, M, Bohm, M, Mahfoud F., Mancia G., Schmieder R., Narkiewicz K., Ruilope L., Schlaich M., Whitbourn R., Zirlik A., Zeller T., Stawowy P., Cohen S. A., Fahy M., and Bohm M.

Abstract

Background: Renal denervation (RDN) is under investigation for treatment of uncontrolled hypertension and might represent an attractive treatment for patients with high cardiovascular (CV) risk. It is important to determine whether baseline CV risk affects the efficacy of RDN. Objectives: The purpose of this study was to assess blood pressure (BP) reduction and event rates after RDN in patients with various comorbidities, testing the hypothesis that RDN is effective and durable in these high-risk populations. Methods: BP reduction and adverse events over 3 years were evaluated for several high-risk subgroups in the GSR (Global proSpective registrY for syMPathetic renaL denervatIon in seleCted IndicatIons Through 3 Years Registry), an international registry of RDN in patients with uncontrolled hypertension (n = 2,652). Comparisons were made for patients age ≥65 years versus age <65 years, with versus without isolated systolic hypertension, with versus without atrial fibrillation, and with versus without diabetes mellitus. Baseline cardiovascular risk was estimated using the American Heart Association (AHA)/American College of Cardiology (ACC) atherosclerosis cardiovascular disease (ASCVD) risk score. Results: Reduction in 24-h systolic BP at 3 years was −8.9 ± 20.1 mm Hg for the overall cohort, and for high-risk subgroups, BP reduction was −10.4 ± 21.0 mm Hg for resistant hypertension, −8.7 ± 17.4 mm Hg in patients age ≥65 years, −10.2 ± 17.9 mm Hg in patients with diabetes, −8.6 ± 18.7 mm Hg in isolated systolic hypertension, −10.1 ± 20.3 mm Hg in chronic kidney disease, and −10.0 ± 19.1 mm Hg in atrial fibrillation (p < 0.0001 compared with baseline for all). BP reduction in patients with measurements at 6, 12, 24, and 36 months showed similar reductions in office and 24-h BP for patients with varying baseline ASCVD risk scores, which was sustained to 3 years. Adverse event rates at 3 years were higher for patients with higher baseline CV risk. Conclusions: B

Published
2020

21. Contemporary management of locally advanced and recurrent rectal cancer: views from the PelvEx collaborative

Author

Kelly M. E., O’Sullivan N. J., Fahy M. R., Aalbers A. G. J., Abdul Aziz N., Abecasis N., Abraham-Nordling M., Abu Saadeh F., Akiyoshi T., Alberda W., Albert M., Andric M., Angeles M. A., Angenete E., Antoniou A., Auer R., Austin K. K., Aytac E., Aziz O., Bacalbasa N., Baker R. P., Bali M., Baransi S., Baseckas G., Bebington B., Bedford M., Bednarski B. K., Beets G. L., Berg P. L., Bergzoll C., Beynon J., Biondo S., Boyle K., Bordeianou L., Brecelj E., Bremers A. B., Brunner M., Buchwald P., Bui A., Burgess A., Burger J. W. A., Burling D., Burns E., Campain N., Carvalhal S., Castro L., Caycedo-Marulanda A., Ceelen W., Chan K. K. L., Chang G. J., Chang M., Chew M. H., Chok A. Y., Chong P., Clouston H., Codd M., Collins D., Colquhoun A. J., Constantinides J., Corr A., Coscia M., Cosimelli M., Cotsoglou C., Coyne P. E., Croner R. S., Damjanovich L., Daniels I. R., Davies M., Delaney C. P., de Wilt J. H. W., Denost Q., Deutsch C., Dietz D., Domingo S., Dozois E. J., Drozdov E., Duff M., Eglinton T., Enriquez-Navascues J. M., Espín-Basany E., Evans M. D., Eyjólfsdóttir B., Fearnhead N. S., Ferron G., Fichtner-Feigl S., Flatmark K., Fleming F. J., Flor B., Folkesson J., Frizelle F. A., Funder J., Gallego M. A., Gargiulo M., García-Granero E., García-Sabrido J. L., Gava V. G., Gentilini L., George M. L., George V., Georgiou P., Ghosh A., Ghouti L., Gil-Moreno A., Giner F., Ginther D. N., Glyn T., Glynn R., Golda T., Griffiths B., Harris D. A., Hanchanale V., Harji D. P., Harris C., Helewa R. M., Hellawell G., Heriot A. G., Hochman D., HohenbergerW., Holm T., Hompes R., Hornung B., Hurton S., Hyun E., Ito M., Iversen L. H., Jenkins J. T., Jourand K., Kaffenberger S., Kandaswamy G. V., Kapur S., Kanemitsu Y., Kazi M., Kelley S. R., Keller D. S., Ketelaers S. H. J., Khan M. S., Kiran R. P., Kim H., Kim H. J., Koh C. E., Kok N. F. M., Kokelaar R., Kontovounisios C., Kose F., Koutra M., Kristensen H. Ø., Kroon H. M., Kumar S., Kusters M., Lago V., Lampe B., Lakkis Z., Larach J. T., Larkin J. O., Larsen S. G., Larson D. W., Law W. L., Lee P. J., Limbert M., Loria A., Lydrup ML., Lyons A., Lynch A. C., Maciel J., Manfredelli S., Mann C., Mantyh C., Mathis K. L., Marques C. F. S., Martinez A., Martling A., Mehigan B. J., MeijerinkW. J. H. J., Merchea A., Merkel S., Mehta A. M., Mikalauskas S., McArthur D. R., McCormick J. J., McCormick P., McDermott F. D., McGrath J. S., Malde S., Mirnezami A., Monson J. R. T., Navarro A. S., Neeff H., Negoi I., Neto J. W. M., Ng J. L., Nguyen B., Nielsen M. B., Nieuwenhuijzen G. A. P., Nilsson P. J., Nordkamp S., Nugent T., Oliver A., O’Dwyer S. T., Paarnio K., Palmer G., Pappou E., Park J., Patsouras D., Peacock O., Pellino G., Peterson A. C., Pfeffer F., Pinson J., Poggioli G., Proud D., Quinn M., Quyn A., Rajendran N., Radwan R. W., Rao C., Rasheed S., Rausa E., Regenbogen S. E., Reims H. M., Renehan A., Rintala J., Rocha R., Rochester M., Rohila J., Rothbarth J., Rottoli M., Roxburgh C., Rutten H. J. T., Safar B., Sagar P. M., Sahai A., Saklani A., Sammour T., Sayyed R., Schizas A. M. P., Schwarzkopf E., Scripcariu D., Scripcariu V., Selvasekar C., Shaikh I., Simpson A., Skeie-Jensen T., Smart N. J., Smart P., Smith J. J., Solbakken A. M., Solomon M. J., Sørensen M. M., Sorrentino L., Steele S. R., Steffens D., Stitzenberg K., Stocchi L., Stylianides N. A., Swartling T., Spasojevic M., Sumrien H., Sutton P. A., Swartking T., Takala H., Tan E. J., Taylor C., Taylor D., Tekin A., Tekkis P. P., Teras J., Thaysen H. V., Thurairaja R., Thorgersen E. B., Tiernan J., Toh E. L., Tolenaar J., Tsarkov P., Tsukada Y., Tsukamoto S., Tuech J. J., Turner W. H., Tuynman J. B., Valente M., van Ramshorst G. H., van Rees J., van Zoggel D., Vasquez-JimenezW., Vather R., Verhoef C., Vierimaa M., Vizzielli G., Voogt E. L. K., Uehara K., Urrejola G., Wakeman C., Warrier S. K., Wasmuth H. H., Waters P. S., Weber K., Weiser M. R., Wheeler J. M. D., Wild J., Williams A., Wilson M., Wolthuis A., Yano H., Yip B., Yoo R. N., Zappa M. A., Winter D. C., and Kelly M.E., O’Sullivan N.J., Fahy M.R., Aalbers A.G.J., Abdul Aziz N., Abecasis N., Abraham-Nordling M., Abu Saadeh F., Akiyoshi T., Alberda W., Albert M., Andric M., Angeles M.A., Angenete E., Antoniou A., Auer R., Austin K.K., Aytac E., Aziz O., Bacalbasa N., Baker R.P., Bali M., Baransi S., Baseckas G., Bebington B., Bedford M., Bednarski B.K., Beets G.L., Berg P.L., Bergzoll C., Beynon J., Biondo S., Boyle K., Bordeianou L., Brecelj E., Bremers A.B., Brunner M., Buchwald P., Bui A., Burgess A., Burger J.W.A., Burling D., Burns E., Campain N., Carvalhal S., Castro L., Caycedo-Marulanda A., Ceelen W., Chan K.K.L., Chang G.J., Chang M., Chew M.H., Chok A.Y., Chong P., Clouston H., Codd M., Collins D., Colquhoun A.J., Constantinides J., Corr A., Coscia M., Cosimelli M., Cotsoglou C., Coyne P.E., Croner R.S., Damjanovich L., Daniels I.R., Davies M., Delaney C.P., de Wilt J.H.W., Denost Q., Deutsch C., Dietz D., Domingo S., Dozois E.J., Drozdov E., Duff M., Eglinton T., Enriquez-Navascues J.M., Espín-Basany E., Evans M.D., Eyjólfsdóttir B., Fearnhead N.S., Ferron G., Fichtner-Feigl S., Flatmark K., Fleming F.J., Flor B., Folkesson J., Frizelle F.A., Funder J., Gallego M.A., Gargiulo M., García-Granero E., García-Sabrido J.L., Gargiulo M., Gava V.G., Gentilini L., George M.L., George V., Georgiou P., Ghosh A., Ghouti L., Gil-Moreno A., Giner F., Ginther D.N., Glyn T., Glynn R., Golda T., Griffiths B., Harris D.A., Hanchanale V., Harji D.P., Harris C., Helewa R.M., Hellawell G., Heriot A.G., Hochman D., HohenbergerW., Holm T., Hompes R., Hornung B., Hurton S., Hyun E., Ito M., Iversen L.H., Jenkins J.T., Jourand K., Kaffenberger S., Kandaswamy G.V., Kapur S., Kanemitsu Y., Kazi M., Kelley S.R., Keller D.S., Ketelaers S.H.J., Khan M.S., Kiran R.P., Kim H., Kim H.J., Koh C.E., Kok N.F.M., Kokelaar R., Kontovounisios C., Kose F., Koutra M., Kristensen H.Ø., Kroon H.M., Kumar S., Kusters M., Lago V., Lampe B., Lakkis Z., Larach J.T., Larkin J.O., Larsen S.G., Larson D.W., Law W.L., Lee P.J., Limbert M., Loria A., Lydrup ML., Lyons A., Lynch A.C., Maciel J., Manfredelli S., Mann C., Mantyh C., Mathis K.L., Marques C.F.S., Martinez A., Martling A., Mehigan B.J., MeijerinkW.J.H.J., Merchea A., Merkel S., Mehta A.M., Mikalauskas S., McArthur D.R., McCormick J.J., McCormick P., McDermott F.D., McGrath J.S., Malde S., Mirnezami A., Monson J.R.T., Navarro A.S., Neeff H., Negoi I., Neto J.W.M., Ng J.L., Nguyen B., Nielsen M.B., Nieuwenhuijzen G.A.P., Nilsson P.J., Nordkamp S., Nugent T., Oliver A., O’Dwyer S.T., Paarnio K., Palmer G., Pappou E., Park J., Patsouras D., Peacock O., Pellino G., Peterson A.C., Pfeffer F., Pinson J., Poggioli G., Proud D., Quinn M., Quyn A., Rajendran N., Radwan R.W., Rajendran N., Rao C., Rasheed S., Rausa E., Regenbogen S.E., Reims H.M., Renehan A., Rintala J., Rocha R., Rochester M., Rohila J., Rothbarth J., Rottoli M., Roxburgh C., Rutten H.J.T., Safar B., Sagar P.M., Sahai A., Saklani A., Sammour T., Sayyed R., Schizas A.M.P., Schwarzkopf E., Scripcariu D., Scripcariu V., Selvasekar C., Shaikh I., Simpson A., Skeie-Jensen T., Smart N.J., Smart P., Smith J.J., Solbakken A.M., Solomon M.J., Sørensen M.M., Sorrentino L., Steele S.R., Steffens D., Stitzenberg K., Stocchi L., Stylianides N.A., Swartling T., Spasojevic M., Sumrien H., Sutton P.A., Swartking T., Takala H., Tan E.J., Taylor C., Taylor D., Tekin A., Tekkis P.P., Teras J., Thaysen H.V., Thurairaja R., Thorgersen E.B., Tiernan J., Toh E.L., Tolenaar J., Tsarkov P., Tsukada Y., Tsukamoto S., Tuech J.J., Turner W.H., Tuynman J.B., Valente M., van Ramshorst G.H., van Rees J., van Zoggel D., Vasquez-JimenezW., Vather R., Verhoef C., Vierimaa M., Vizzielli G., Voogt E.L.K., Uehara K., Urrejola G., Wakeman C., Warrier S.K.,Wasmuth H.H.,Waters P.S.,Weber K.,Weiser M.R., Wheeler J.M.D.,Wild J., Williams A., Wilson M., Wolthuis A., Yano H., Yip B., Yoo R.N., Zappa M.A., Winter D.C.

Subjects
Cancer Research, perioperative care, ENHANCED RECOVERY, diagnostic, EXENTERATION, surgical management, surgical outcomes, recurrent rectal cancer, SDG 3 - Good Health and Well-being, locally advanced rectal cancer, QUALITY-OF-LIFE, Medicine and Health Sciences, diagnostics, 1112 Oncology and Carcinogenesis, PATHOLOGICAL COMPLETE RESPONSE, rectal cancer, SURGICAL TECHNIQUES, OUTCOMES, Science & Technology, HYPERTHERMIC INTRAPERITONEAL, PelvEx Collaborative, CHEMOTHERAPY, WHOLE-BODY MRI, NEOADJUVANT CHEMORADIOTHERAPY, Oncology, quality of life, CYTOREDUCTIVE SURGERY, HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY, Life Sciences & Biomedicine
Abstract

Pelvic exenteration is a complex operation performed for locally advanced and recurrent pelvic cancers. The goal of surgery is to achieve clear margins, therefore identifying adjacent or involved organs, bone, muscle, nerves and/or vascular structures that may need resection. While these extensive resections are potentially curative, they can be associated with substantial morbidity. Recently, there has been a move to centralize care to specialized units, as this facilitates better multidisciplinary care input. Advancements in pelvic oncology and surgical innovation have redefined the boundaries of pelvic exenterative surgery. Combined with improved neoadjuvant therapies, advances in diagnostics, and better reconstructive techniques have provided quicker recovery and better quality of life outcomes, with improved survival This article provides highlights of the current management of advanced pelvic cancers in terms of surgical strategy and potential future developments.

Published
2022
Full Text
View/download PDF

22. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial

Author

Mahfoud, F. Kandzari, D.E. Kario, K. Townsend, R.R. Weber, M.A. Schmieder, R.E. Tsioufis, K. Pocock, S. Dimitriadis, K. Choi, J.W. East, C. D'Souza, R. Sharp, A.S.P. Ewen, S. Walton, A. Hopper, I. Brar, S. McKenna, P. Fahy, M. Böhm, M.

Abstract

Background: Renal denervation has been shown to lower blood pressure in the presence of antihypertensive medications; however, long-term safety and efficacy data from randomised trials of renal denervation are lacking. In this pre-specified analysis of the SPYRAL HTN-ON MED study, we compared changes in blood pressure, antihypertensive drug use, and safety up to 36 months in renal denervation versus a sham control group. Methods: This randomised, single-blind, sham-controlled trial enrolled patients from 25 clinical centres in the USA, Germany, Japan, the UK, Australia, Austria, and Greece, with uncontrolled hypertension and office systolic blood pressure between 150 mm Hg and 180 mm Hg and diastolic blood pressure of 90 mm Hg or higher. Eligible patients had to have 24-h ambulatory systolic blood pressure between 140 mm Hg and less than 170 mm Hg, while taking one to three antihypertensive drugs with stable doses for at least 6 weeks. Patients underwent renal angiography and were randomly assigned (1:1) to radiofrequency renal denervation or a sham control procedure. Patients and physicians were unmasked after 12-month follow-up and sham control patients could cross over after 12-month follow-up completion. The primary endpoint was the treatment difference in mean 24-h systolic blood pressure at 6 months between the renal denervation group and the sham control group. Statistical analyses were done on the intention-to-treat population. Long-term efficacy was assessed using ambulatory and office blood pressure measurements up to 36 months. Drug surveillance was used to assess medication use. Safety events were assessed up to 36 months. This trial is registered with ClinicalTrials.gov, NCT02439775; prospectively, an additional 260 patients are currently being randomly assigned as part of the SPYRAL HTN-ON MED Expansion trial. Findings: Between July 22, 2015, and June 14, 2017, among 467 enrolled patients, 80 patients fulfilled the qualifying criteria and were randomly assigned to undergo renal denervation (n=38) or a sham control procedure (n=42). Mean ambulatory systolic and diastolic blood pressure were significantly reduced from baseline in the renal denervation group, and were significantly lower than the sham control group at 24 and 36 months, despite a similar treatment intensity of antihypertensive drugs. The medication burden at 36 months was 2·13 medications (SD 1·15) in the renal denervation group and 2·55 medications (2·19) in the sham control group (p=0·26). 24 (77%) of 31 patients in the renal denervation group and 25 (93%) of 27 patients in the sham control group adhered to medication at 36 months. At 36 months, the ambulatory systolic blood pressure reduction was −18·7 mm Hg (SD 12·4) for the renal denervation group (n=30) and −8·6 mm Hg (14·6) for the sham control group (n=32; adjusted treatment difference −10·0 mm Hg, 95% CI −16·6 to −3·3; p=0·0039). Treatment differences between the renal denervation group and sham control group at 36 months were −5·9 mm Hg (95% CI −10·1 to −1·8; p=0·0055) for mean ambulatory diastolic blood pressure, −11·0 mm Hg (−19·8 to −2·1; p=0·016) for morning systolic blood pressure, and −11·8 mm Hg (−19·0 to −4·7; p=0·0017) for night-time systolic blood pressure. There were no short-term or long-term safety issues associated with renal denervation. Interpretation: Radiofrequency renal denervation compared with sham control produced a clinically meaningful and lasting blood pressure reduction up to 36 months of follow-up, independent of concomitant antihypertensive medications and without major safety events. Renal denervation could provide an adjunctive treatment modality in the management of patients with hypertension. Funding: Medtronic. © 2022 Elsevier Ltd

Published
2022

25. Effects of renal denervation on kidney function and long-term outcomes: 3-year follow-up from the Global SYMPLICITY Registry

Author

Mahfoud, F, Bohm, M, Schmieder, R, Narkiewicz, K, Ewen, S, Ruilope, L, Schlaich, M, Williams, B, Fahy, M, Mancia, G, Mahfoud F., Bohm M., Schmieder R., Narkiewicz K., Ewen S., Ruilope L., Schlaich M., Williams B., Fahy M., Mancia G., Mahfoud, F, Bohm, M, Schmieder, R, Narkiewicz, K, Ewen, S, Ruilope, L, Schlaich, M, Williams, B, Fahy, M, Mancia, G, Mahfoud F., Bohm M., Schmieder R., Narkiewicz K., Ewen S., Ruilope L., Schlaich M., Williams B., Fahy M., and Mancia G.

Abstract

Aims: Several studies and registries have demonstrated sustained reductions in blood pressure (BP) after renal denervation (RDN). The long-term safety and efficacy after RDN in real-world patients with uncontrolled hypertension, however, remains unknown. The objective of this study was to assess the long-term safety and efficacy of RDN, including its effects on renal function. Methods and results: The Global SYMPLICITY Registry is a prospective, open-label registry conducted at 196 active sites worldwide in hypertensive patients receiving RDN treatment. Among 2237 patients enrolled and treated with the SYMPLICITY Flex catheter, 1742 were eligible for follow-up at 3 years. Baseline office and 24-h ambulatory systolic BP (SBP) were 166 ± 25 and 154 ± 18 mmHg, respectively. SBP reduction after RDN was sustained over 3 years, including decreases in both office (-16.5 ± 28.6 mmHg, P < 0.001) and 24-h ambulatory SBP (-8.0 ± 20.0 mmHg; P < 0.001). Twenty-one percent of patients had a baseline estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2. Between baseline and 3 years, renal function declined by 7.1 mL/min/1.73 m2 in patients without chronic kidney disease (CKD; eGFR ≥60 mL/min/1.73 m2; baseline eGFR 87 ± 17 mL/min/1.73 m2) and by 3.7 mL/min/1.73 m2 in patients with CKD (eGFR <60 mL/min/1.73 m2; baseline eGFR 47 ± 11 mL/min/1.73 m2). No long-term safety concerns were observed following the RDN procedure. Conclusion: Long-term data from the Global SYMPLICITY Registry representing the largest available cohort of hypertensive patients receiving RDN in a real-world clinical setting demonstrate both the safety and efficacy of the procedure with significant and sustained office and ambulatory BP reductions out to 3 years.

Published
2019

27. Correction to: Rationale and design of two randomized sham‑controlled of catheter‑based renal denervation in subjects with uncontrolled hypertension in the absence (SPYRAL HTN‑OFF MED Pivotal) and presence (SPYRAL HTN‑ON MED Expansion) of antihypertensive medications: a novel approach using Bayesian design (Clinical Research in Cardiology, (2020), 109, 3, (289-302), 10.1007/s00392-020-01595-z)

Author

Böhm, M. Townsend, R.R. Kario, K. Kandzari, D. Mahfoud, F. Weber, M.A. Schmieder, R.E. Tsioufis, K. Hickey, G.L. Fahy, M. DeBruin, V. Brar, S. Pocock, S.

Abstract

The original version of this article unfortunately contained a mistake. © 2020, The Author(s).

Published
2020

28. The global cost of pelvic exenteration:in-hospital perioperative costs

Author

Kelly, M. E., Agj, Aalbers, Abdul Aziz, N., Abecasis, N., Abraham-Nordling, M., Akiyoshi, T., Alberda, W., Albert, M., Andric, M., Angenete, E., Antoniou, A., Auer, R., Austin, K. K., Aziz, O., Baker, R. P., Bali, M., Baseckas, G., Bebington, B., Bedford, M., Bednarski, B. K., Beets, G. L., Berg, P. L., Beynon, J., Biondo, S., Boyle, K., Bordeianou, L., Bremers, A. B., Brunner, M., Buchwald, P., Bui, A., Burgess, A., Jwa, Burger, Burling, D., Burns, E., Campain, N., Carvalhal, S., Castro, L., Caycedo-Marulanda, A., Kkl, Chan, Chang, G. J., Chang, M., Chew, M. H., Chok, A. K., Chong, P., Christensen, H. K., Clouston, H., Codd, M., Collins, D., Colquhoun, A. J., Corr, A., Coscia, M., Cosimelli, M., Coyne, P. E., Croner, R. S., Damjanovic, L., Daniels, I. R., Davies, M., Davies, R. J., Delaney, C. P., Jhw, Wilt, Denost, Q., Deutsch, C., Dietz, D., Domingo, S., Dozois, E. J., Duff, M., Eglinton, T., Enrique-Navascues, J. M., Espin-Basany, E., Evans, M. D., Eyjólfsdóttir, B., Fahy, M., Fearnhead, N. S., Flatmark, K., Fleming, F., Folkesson, J., Frizelle, F. A., Gallego, M. A., Garcia-Granero, E., Garcia-Sabrido, J. L., Gentilini, L., George, M. L., George, V., Ghouti, L., Giner, F., Ginther, N., Glynn, R., Golda, T., Griffiths, B., Harris, D. A., Jaw, Hagemans, Hanchanale, V., Harji, D. P., Helewa, R. M., Hellawell, G., Heriot, A. G., Hochman, D., Hohenberger, W., Holm, T., Hompes, R., Jenkins, J. T., Kaffenberger, S., Kandaswamy, G. V., Kapur, S., Kanemitsu, Y., Kelley, S. R., Keller, D. S., Khan, M. S., Kim, H. J., Koh, C. E., Nfm, Kok, Kokelaar, R., Kontovounisios, C., Kristensen, H., Kroon, H. M., Kumar, S., Kusters, M., Lago, V., Lakkis, Z., Larsen, S. G., Larson, D. W., Law, W. L., Laurberg, S., Lee, P. J., Limbert, M., Lydrup, M. L., Lyons, A., Lynch, A. C., Mantyh, C., Mathis, K. L., Cfs, Margues, Martling, A., Wjhj, Meijerink, Merchea, A., Merkel, S., Mehta, A. M., McArthur, D. R., McDermott, F. D., McGrath, J. S., Malde, S., Mirnezami, A., Jrt, Monson, Morton, J. R., Mullaney, T. G., Negoi, I., Jwm, Neto, Ng, J. L., Nguyen, B., Nielsen, M. B., Gap, Nieuwenhuijzen, Nilsson, P. J., Oliver, A., O'Dwyer, S. T., Palmer, G., Pappou, E., Park, J., Patsouras, D., Pellino, G., Peterson, A. C., Poggioli, G., Proud, D., Quinn, M., Quyn, A., Rajendran, N., Radwan, R. W., Rasheed, S., Rasmussen, P. C., Rausa, E., Regenbogen, S. E., Renehan, A., Rocha, R., Rochester, M., Rohila, J., Rothbarth, J., Rottoli, M., Roxburgh, C., Hjt, Rutten, Safar, B., Sagar, P. M., Sahai, A., Saklani, A., Sammour, T., Sayyed, R., Amp, Schizas, Schwarzkopf, E., Scripcariu, V., Selvasekar, C., Shaikh, I., Shida, D., Simpson, A., Skeie-Jensen, T., Smart, N. J., Smart, P., Smith, J. J., Solbakken, A. M., Solomon, M. J., Sørensen, M. M., Steele, S. R., Steffens, D., Stitzenberg, K., Stocchi, L., Stylianides, N. A., Swartling, T., Sumrien, H., Sutton, P. A., Swartking, T., Tan, E. J., Taylor, C., Tekkis, P. P., Teras, J., Thurairaja, R., Toh, E. L., Tsarkov, P., Tsukada, Y., Tsukamoto, S., Tuech, J. J., Turner, W. H., Tuynman, J. B., van Ramshorst, G. H., van Zoggel, D., Vasquez-Jimenez, W., Verhoef, C., Vizzielli, G., Elk, Voogt, Uehara, K., Wakeman, C., Warrier, S., Wasmuth, H. H., Weber, K., Weiser, M. R., Jmd, Wheeler, Wild, J., Wilson, M., Wolthuis, A., Yano, H., Yip, B., Yip, J., Yoo, R. N., Zappa, M. A., Winter, D. C., Kelly, M. E., Agj, Aalbers, Abdul Aziz, N., Abecasis, N., Abraham-Nordling, M., Akiyoshi, T., Alberda, W., Albert, M., Andric, M., Angenete, E., Antoniou, A., Auer, R., Austin, K. K., Aziz, O., Baker, R. P., Bali, M., Baseckas, G., Bebington, B., Bedford, M., Bednarski, B. K., Beets, G. L., Berg, P. L., Beynon, J., Biondo, S., Boyle, K., Bordeianou, L., Bremers, A. B., Brunner, M., Buchwald, P., Bui, A., Burgess, A., Jwa, Burger, Burling, D., Burns, E., Campain, N., Carvalhal, S., Castro, L., Caycedo-Marulanda, A., Kkl, Chan, Chang, G. J., Chang, M., Chew, M. H., Chok, A. K., Chong, P., Christensen, H. K., Clouston, H., Codd, M., Collins, D., Colquhoun, A. J., Corr, A., Coscia, M., Cosimelli, M., Coyne, P. E., Croner, R. S., Damjanovic, L., Daniels, I. R., Davies, M., Davies, R. J., Delaney, C. P., Jhw, Wilt, Denost, Q., Deutsch, C., Dietz, D., Domingo, S., Dozois, E. J., Duff, M., Eglinton, T., Enrique-Navascues, J. M., Espin-Basany, E., Evans, M. D., Eyjólfsdóttir, B., Fahy, M., Fearnhead, N. S., Flatmark, K., Fleming, F., Folkesson, J., Frizelle, F. A., Gallego, M. A., Garcia-Granero, E., Garcia-Sabrido, J. L., Gentilini, L., George, M. L., George, V., Ghouti, L., Giner, F., Ginther, N., Glynn, R., Golda, T., Griffiths, B., Harris, D. A., Jaw, Hagemans, Hanchanale, V., Harji, D. P., Helewa, R. M., Hellawell, G., Heriot, A. G., Hochman, D., Hohenberger, W., Holm, T., Hompes, R., Jenkins, J. T., Kaffenberger, S., Kandaswamy, G. V., Kapur, S., Kanemitsu, Y., Kelley, S. R., Keller, D. S., Khan, M. S., Kim, H. J., Koh, C. E., Nfm, Kok, Kokelaar, R., Kontovounisios, C., Kristensen, H., Kroon, H. M., Kumar, S., Kusters, M., Lago, V., Lakkis, Z., Larsen, S. G., Larson, D. W., Law, W. L., Laurberg, S., Lee, P. J., Limbert, M., Lydrup, M. L., Lyons, A., Lynch, A. C., Mantyh, C., Mathis, K. L., Cfs, Margues, Martling, A., Wjhj, Meijerink, Merchea, A., Merkel, S., Mehta, A. M., McArthur, D. R., McDermott, F. D., McGrath, J. S., Malde, S., Mirnezami, A., Jrt, Monson, Morton, J. R., Mullaney, T. G., Negoi, I., Jwm, Neto, Ng, J. L., Nguyen, B., Nielsen, M. B., Gap, Nieuwenhuijzen, Nilsson, P. J., Oliver, A., O'Dwyer, S. T., Palmer, G., Pappou, E., Park, J., Patsouras, D., Pellino, G., Peterson, A. C., Poggioli, G., Proud, D., Quinn, M., Quyn, A., Rajendran, N., Radwan, R. W., Rasheed, S., Rasmussen, P. C., Rausa, E., Regenbogen, S. E., Renehan, A., Rocha, R., Rochester, M., Rohila, J., Rothbarth, J., Rottoli, M., Roxburgh, C., Hjt, Rutten, Safar, B., Sagar, P. M., Sahai, A., Saklani, A., Sammour, T., Sayyed, R., Amp, Schizas, Schwarzkopf, E., Scripcariu, V., Selvasekar, C., Shaikh, I., Shida, D., Simpson, A., Skeie-Jensen, T., Smart, N. J., Smart, P., Smith, J. J., Solbakken, A. M., Solomon, M. J., Sørensen, M. M., Steele, S. R., Steffens, D., Stitzenberg, K., Stocchi, L., Stylianides, N. A., Swartling, T., Sumrien, H., Sutton, P. A., Swartking, T., Tan, E. J., Taylor, C., Tekkis, P. P., Teras, J., Thurairaja, R., Toh, E. L., Tsarkov, P., Tsukada, Y., Tsukamoto, S., Tuech, J. J., Turner, W. H., Tuynman, J. B., van Ramshorst, G. H., van Zoggel, D., Vasquez-Jimenez, W., Verhoef, C., Vizzielli, G., Elk, Voogt, Uehara, K., Wakeman, C., Warrier, S., Wasmuth, H. H., Weber, K., Weiser, M. R., Jmd, Wheeler, Wild, J., Wilson, M., Wolthuis, A., Yano, H., Yip, B., Yip, J., Yoo, R. N., Zappa, M. A., and Winter, D. C.

Published
2020

34. Seventeenth sir peter freyer memorial lecture and surgical symposium: September 18th & 19th, 1992

Author

O’Gradaigh, D., Byrne, P. J., Gillen, P., Lawlor, P., Walsh, T. N., Hennessy, T. P. J., O’Sullivan, S. T., O’Sullivan, G. C., Kirwan, W. O., Li, H., Caldwell, M. T. P., Hone, S., Attwood, S. E. A., Kelly, I. P., Corrigan, T. P., Mulligan, E., Kerin, M. J., Williams, N. N., Cronin, K. J., Sadar, M. El, Dervan, P., Fitzpatrick, J. M., Gorey, T. F., Maher, M., Hehir, D., Horgan, A., Stuart, R., O’Donnell, J. A., Brady, M. P., O’Donoghue, J. M., Flynn, J. R., Doyle, J., Gallagher, M., Connolly, K., Barry, M., Davies, M. G, West, M., O’Broin, E., Connolly, J. A., Long, D., Shine, M. F., Lennon, F., Dawson, K. J., Novell, J. R., Burroughs, A. K., Rolles, K., Joyce, W. P., Dolan, J., Hyland, J., Traynor, O., Bennett, M., Tighe, O., Mulcahy, H., O’Donoghue, D., Bouchier-Hayes, D., Croke, D. T., Santos, G., Khoury, G., Winslet, M. C., Lewis, A. A. M., Beausang, E., Mealy, K., Joyce, L., McNicholls, M., McErlean, D., Stokes, M. A., Barry, K., Sullivan, R., Byrne, J., Callaghan, J., O’Gorman°, T., Given, H. F., Dudeney, M. S., Redmond, M. P., Deasy, J. M., Young, V. K., Watson, R. G. K., O’Kane, G., Murphy, K., McDowell, C., Khan, K., Al-Ghazal, S. K., McCann, J., Stuart, R. C., O’Connor, M., McCabe, J., O’Byrne, J., O’Farrell, D., Walsh, M., O’Beirne, J., O’Flannagan, S., McGuinness, A., Brady, O., Quinlan, W., McCabe, J. P., Curtin, B., Stephens, M., Stack, J., McCarthy, P., Schnall, M., Pollack, H., Lynch, T. H., Waymont, B., Dunn, J. A., Hughes, M. A., Wallace, D. M. A., McDermott, T. E. D., Grainger, R., Rogers, E., Corcoran, M., Bredin, H., Grimes, H., Lanigan, D., Roobottom, C., Dubbins, P. A., Choa, R. G., Creagh, T., Butler, M. R., O’Flynn, K. J., MacDonagh, R. P., Thomas, D. G., Dawson, K., Aitken, J., Cooke, B., Parbhoo, S. P., Cannon, P. M., Low, S. C., Dixon, A., Ellis, I. O., Elston, C. W., Blarney, R. W., Mulligan, E. D., Cronin, K., Stack, A., Ennis, J., Gorey, T. F., Abbaskoor, F., O’Donoghue, M. K., Fulton, G., Tanner, W. A., Keane, F. B. V., Joseph, B. V., Cunningham, F. O., Dowling, M., Conveney, E., Geraghty, J. G., Byrne, P., Clarke, G., Duffy, J., O’Higgins, N., O’Hanlon, D., Horgan, P. G., O’Brien, D., Phelan, C., Given, P., Barry, M., Kent, P., Sheehan, S., Colgan, M. P., Moore, D., Shanik, G., Kent, P., Murphy, P., Sheehan, S., Colgan, M. P., Moore, D., Shanik, G., Vashisht, R., Sian, M., Franks, P., O’Malley, M. K., Hone, S., Gul, Y., Waldron, D., Hederman, W. P., Hone, S., Gul, Y., Waldron, D., Hederman, W. P., Maher, M., Singh, H. P., Dias, S., Aherne, T., O’Sullivan, S. T., Hehir, D. J., O’Connor, M., O’Donnell, J. A., Brady, M. P., McKeever, J. A., Stokes, M. A., Bannon, C. A., Beausang, E., Mehigan, D., Keaveney, T. V., Browne, T. F., Sivananthan, U. M., Rees, M. R., Whittaker, S., Davies, G. A., Vashisght, R., Sharp, E., Coady, A., Sterpetti, A., Greenhalgh, R. M., O’Malley, M. K., O’Brien, D. P., Gough, D. B., Horgan, P. G., Phelan, C., Given, H. F., Regan, M. C., Efron, I. E., Kirk, S. I., Hurson, M., Wasserkrug, H. L., Barbul, A., Browne, T. F., Haynes, S., Davies, G. A., Thornton, J., Sparkes, J., Hill, A. D. K., Gillen, P., Walsh, T. N., Hennessy, T. P. J., Kelly, C. J., Gallagher, J., Modyka, L., Redmond, H. P., Daly, J. M., Austin, O. M., Redmond, H. P., Cunney, R. J., Grace, P. A., Bouchier-Hayes, D., Curran, C., Byrne, J., O’Donoghue, J., Horgan, P. G., Given, H. F., Stokes, M. A., Abernathy, M., Sharpe, N., Lucy, M., McDermott, E. W. D., Mercer, P. M., O’Higgins, N. J., Murugasu, G., Geraghty, J. G., Groeschel, A., Carmody, M., Donohue, J., Osborne, D. H., O’Brien, D. P., McLaughlin, M., Devlin, J., Phillips, J. P., Ellias, Y., Tahir, M., McKeever, J., Tighe, M., Lynch, V., Ahmed, M., Smyth, P. P. A., Hetherton, A. M., Cunningham, F. O., O’Hanlon, D., Horgan, P., Little, M., Given, H. F., Quill, D. S., Duncan, C. O., McKeever, J. A., Stokes, M. A., Lynch, V., O’Donnell, M., Hobby, J. A. E., Little, D., Murphy, M., Mealy, K., Burke, P., Broe, P., Al-Ghazal, S. K., McKiernan, M., Khan, K., McCann, J., Murphy, M., Mealy, K., Broe, P., O’Donnell, M., Hobby, J. A. E., Regan, M. C., Kirk, S. J., Hurson, M., Wasserkrug, H. L., Barbul, A., Cronin, K. J., Kerin, M. J., Williams, N. N., Attwood, S. E. A., Crowe, J., MacMathuna, P., Lennon, J., Corrigan, T., O’Connell, R., Fitzpatrick, J. M., Gorey, T. F., Browne, A., Quershi, A., Leahy, A., Courtney, G., Grace, P., Osborne, H., Bouchier-Hayes, D., Dudeney, M. S., Redmond, H. P., Grace, P. A., Bouchier-Hayes, D., Buckley, D. J., Hehir, D. J., Kirwan, W. O., Goggin, M., Joyce, W. P., Traynor, O., Hyland, J., Buckley, D. J., Hehir, D. J., Kirwan, W. O., Farrell, T. A., Geraghty, J., Keeling, F. K., Kelly, I. P., Attwood, S. E. A., O’Connell, P. R., Corrigan, T. P., Hill, A. D. K., Redmond, H. P., Naama, H., Grace, P. A., Bouchier-Hayes, D., Moore, E., Barry, E., Duffy, C., Hogan, P., Nee, G., Fahy, M., McKiernan, M., Kenny, D. P., McCann, J., Ellias, V., Gibney, E., Joyce, W., Traynor, O., Gaffney, E., Doyle, J., Dervan, P., McMahon, J., McCabe, M., Kelly, P., Leader, M., Timon, C. I., Gullane, P., Dardick, I., Redmond, H. P., McCarthy, I., Dudeney, M. S., Hill, A. D. K., Grace, P. A., Bouchier-Hayes, D., Williams, N. N., Joyce, W. P., Couse, N. F., Morrin, M., and Delaney, P. V.

Published
1994
Full Text
View/download PDF

37. Royal academy of medicine in ireland section of biological sciences: Proceedings of the section of biological sciences section, summer meeting, ucg, 23rd & 24th june, 1989.

Author

McCabe, J. P., Waldron, R. P., Kerin, M. J., Courtney, D. F., Given, H. F., McAnena, O. J., Grimes, H., Tymkewycz, P. M., Gascoine, P. S., Gaffney, P. J., Felle, P., Gaine, S., Cox, J., England, R., Walsh, J., Coakley, D., Feely, J., O’Brien, E., O’Malley, K., Daly, L., Sheppard, B. L., Carroll, E., Hennelly, B., Bonnar, J., Fahy, M. M., Carragher, V., Kane, M. T., McGuinness, S., Pratt, I., Ryan, M. P., Cahill, P. A., Daly, S., Keenan, A. K., Barrett, R. P., Rowan, M. J., Smyth, Maria, O’Cuinn, G., Sharma, S. C., Sheppard, B. L., Bonnar, J., Feely, S., Kennedy, M., O’Regan, R. G., Hughes, Gwen, Allen, J. M., McHale, N. G., Thombury, K. D., Croal, S., Anderson, J. McC, Allen, J. D., Jamison, J. P., Mercer, C. G., Gracey, A. E., Flynn, N., Otoole, D. P., O’Malley, K., Clery, A. P., Cunningham, A. J., Dundee, J. W., Ghaly, R. G., Yang, Jing, Sharma, S. C., Etwebi, A. B., Alazreg, A. A., Lavelle, S. M., Etwebi, A., Comerford, F. R., Donohoe, N., Kagashe, Godeliver A. B., Leonard, B. E., Kelly, J. P., Bannon, C., Nolan, P., Bradford, A., McGlynn, H., Kavanagh, B., Bullock, Caroline G., O’Connor, Brigid A., Pippard, Corinna J., Wallace, W. F. M., Holland, P. C., Pratt, I., Ryan, M. P., Blake, M., Redmond, E., Keenan, A. K., Redmond, E. M., Brennan, M., Anwyl, R., Gaynor, A., Luckwill, R. G., Caldwell, M., Lyons, O., McNamara, D., Lynott, A., Fleming, F., Walsh, R., Farrell, L., Homer, C. H., Glacken, P., O’Brien, M., Caird, J., Grogan, A., Ng, C. Y., Glacken, P., O’Brien, M., Arora, A., Carroll, M., McKone, E., O’Gradaigh, D., O’Reilly, P. M. R., FitzGerald, M. J. T., Tierney, S., Russell, J., and Folan, J. C.

Published
1990
Full Text
View/download PDF

38. The lattice locations of silicon atoms in delta-doped layers in GaAs

Author

Ashwin, M.J., Fahy, M., Harris, J.J., Newman, R.C., Sansom, D.A., Addinall, R., McPhail, D.S., and Sharma, V.K.M.

Subjects
Silicon -- Research, Gallium arsenide semiconductors -- Research, Semiconductor doping -- Romania, Physics
Abstract

The incorporation of Si delta-doped planes into GaAs grown by molecular beam epitaxy was investigated using secondary ion mass spectrometry, local vibrational mode infrared absorption and electrical characterization. The results showed that the density of Si(sub Ga) donors, the free electron concentration and the total Si coverage were associated with each other. However, when the Si coverage was greater than 10(super 13) cm(super -2), electron density decreased while the Si(sub Ga) remained constant.

Published
1993

39. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial

Author

Kandzari, DE, Böhm, M, Mahfoud, F, Townsend, RR, Weber, MA, Pocock, S, Tsioufis, K, Tousoulis, D, Choi, JW, East, C, Brar, S, Cohen, SA, Fahy, M, Pilcher, G, Kario, K, SPYRAL HTN-ON MED Trial Investigators, COLLABORATORS, Aoki, J, Batson, B, Cohen, DL, Dangas, G, David, S, Davies, J, Devireddy, CM, Kandzari, D, Lee, DP, Lurz, PC, Papademetriou, V, Patel, M, Patel, K, Schmieder, RE, Sharp, ASP, Singh, J, Walton, A, Weber, T, Weil, J, Zeller, T, Ziada, K, Tanabe, K, Wilkins, R, Wilensky, R, Contreras, J, Steigerwalt, S, Chapman, N, Lea, JP, Reedus, D, Hoshide, S, Ma, A, Fengler, K, Li, P, Svetkey, L, Rao, A, Schmid, A, Watkinson, AF, Brown, A, Hopper, I, Suppan, M, Agdirlioglu, T, Noory, E, and Chasen, C

Abstract

Previous catheter-based renal denervation studies have reported variable efficacy results. We aimed to evaluate safety and blood pressure response after renal denervation or sham control in patients with uncontrolled hypertension on antihypertensive medications with drug adherence testing. : In this international, randomised, single-blind, sham-control, proof-of-concept trial, patients with uncontrolled hypertension (aged 20-80 years) were enrolled at 25 centres in the USA, Germany, Japan, UK, Australia, Austria, and Greece. Eligible patients had an office systolic blood pressure of between 150 mm Hg and 180 mm Hg and a diastolic blood pressure of 90 mm Hg or higher; a 24 h ambulatory systolic blood pressure of between 140 mm Hg and 170 mm Hg at second screening; and were on one to three antihypertensive drugs with stable doses for at least 6 weeks. Patients underwent renal angiography and were randomly assigned to undergo renal denervation or sham control. Patients, caregivers, and those assessing blood pressure were masked to randomisation assignments. The primary efficacy endpoint was blood pressure change from baseline (measured at screening visit two), based on ambulatory blood pressure measurements assessed at 6 months, as compared between treatment groups. Drug surveillance was used to assess medication adherence. The primary analysis was done in the intention-to-treat population. Safety events were assessed through 6 months as per major adverse events. This trial is registered with ClinicalTrials.gov, number NCT02439775, and follow-up is ongoing. : Between July 22, 2015, and June 14, 2017, 467 patients were screened and enrolled. This analysis presents results for the first 80 patients randomly assigned to renal denervation (n=38) and sham control (n=42). Office and 24 h ambulatory blood pressure decreased significantly from baseline to 6 months in the renal denervation group (mean baseline-adjusted treatment differences in 24 h systolic blood pressure -7·0 mm Hg, 95% CI -12·0 to -2·1; p=0·0059, 24 h diastolic blood pressure -4·3 mm Hg, -7·8 to -0·8; p=0.0174, office systolic blood pressure -6·6 mm Hg, -12·4 to -0·9; p=0·0250, and office diastolic blood pressure -4·2 mm Hg, -7·7 to -0·7; p=0·0190). The change in blood pressure was significantly greater at 6 months in the renal denervation group than the sham-control group for office systolic blood pressure (difference -6·8 mm Hg, 95% CI -12·5 to -1·1; p=0·0205), 24 h systolic blood pressure (difference -7·4 mm Hg, -12·5 to -2·3; p=0·0051), office diastolic blood pressure (difference -3·5 mm Hg, -7·0 to -0·0; p=0·0478), and 24 h diastolic blood pressure (difference -4·1 mm Hg, -7·8 to -0·4; p=0·0292). Evaluation of hourly changes in 24 h systolic blood pressure and diastolic blood pressure showed blood pressure reduction throughout 24 h for the renal denervation group. 3 month blood pressure reductions were not significantly different between groups. Medication adherence was about 60% and varied for individual patients throughout the study. No major adverse events were recorded in either group. : Renal denervation in the main renal arteries and branches significantly reduced blood pressure compared with sham control with no major safety events. Incomplete medication adherence was common. : Medtronic.

Published
2018

40. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial

Author

Kandzari, D.E. Böhm, M. Mahfoud, F. Townsend, R.R. Weber, M.A. Pocock, S. Tsioufis, K. Tousoulis, D. Choi, J.W. East, C. Brar, S. Cohen, S.A. Fahy, M. Pilcher, G. Kario, K. Aoki, J. Batson, B. Böhm, M. Choi, J.W. Cohen, D.L. Dangas, G. David, S. Davies, J. Devireddy, C.M. Kandzari, D. Kario, K. Lee, D.P. Lurz, P.C. Papademetriou, V. Patel, M. Patel, K. Schmieder, R.E. Sharp, A.S.P. Singh, J. Tsioufis, K. Walton, A. Weber, T. Weil, J. Zeller, T. Ziada, K. Tanabe, K. Wilkins, R. Mahfoud, F. East, C. Wilensky, R. Contreras, J. Steigerwalt, S. Chapman, N. Lea, J.P. Reedus, D. Hoshide, S. Ma, A. Fengler, K. Li, P. Svetkey, L. Rao, A. Schmid, A. Watkinson, A.F. Brown, A. Tousoulis, D. Hopper, I. Suppan, M. Agdirlioglu, T. Noory, E. Chasen, C. SPYRAL HTN-ON MED Trial Investigators

Abstract

Background: Previous catheter-based renal denervation studies have reported variable efficacy results. We aimed to evaluate safety and blood pressure response after renal denervation or sham control in patients with uncontrolled hypertension on antihypertensive medications with drug adherence testing. Methods: In this international, randomised, single-blind, sham-control, proof-of-concept trial, patients with uncontrolled hypertension (aged 20–80 years) were enrolled at 25 centres in the USA, Germany, Japan, UK, Australia, Austria, and Greece. Eligible patients had an office systolic blood pressure of between 150 mm Hg and 180 mm Hg and a diastolic blood pressure of 90 mm Hg or higher; a 24 h ambulatory systolic blood pressure of between 140 mm Hg and 170 mm Hg at second screening; and were on one to three antihypertensive drugs with stable doses for at least 6 weeks. Patients underwent renal angiography and were randomly assigned to undergo renal denervation or sham control. Patients, caregivers, and those assessing blood pressure were masked to randomisation assignments. The primary efficacy endpoint was blood pressure change from baseline (measured at screening visit two), based on ambulatory blood pressure measurements assessed at 6 months, as compared between treatment groups. Drug surveillance was used to assess medication adherence. The primary analysis was done in the intention-to-treat population. Safety events were assessed through 6 months as per major adverse events. This trial is registered with ClinicalTrials.gov, number NCT02439775, and follow-up is ongoing. Findings: Between July 22, 2015, and June 14, 2017, 467 patients were screened and enrolled. This analysis presents results for the first 80 patients randomly assigned to renal denervation (n=38) and sham control (n=42). Office and 24 h ambulatory blood pressure decreased significantly from baseline to 6 months in the renal denervation group (mean baseline-adjusted treatment differences in 24 h systolic blood pressure −7·0 mm Hg, 95% CI −12·0 to −2·1; p=0·0059, 24 h diastolic blood pressure −4·3 mm Hg, −7·8 to −0·8; p=0.0174, office systolic blood pressure −6·6 mm Hg, −12·4 to −0·9; p=0·0250, and office diastolic blood pressure −4·2 mm Hg, −7·7 to −0·7; p=0·0190). The change in blood pressure was significantly greater at 6 months in the renal denervation group than the sham-control group for office systolic blood pressure (difference −6·8 mm Hg, 95% CI −12·5 to −1·1; p=0·0205), 24 h systolic blood pressure (difference −7·4 mm Hg, −12·5 to −2·3; p=0·0051), office diastolic blood pressure (difference −3·5 mm Hg, −7·0 to −0·0; p=0·0478), and 24 h diastolic blood pressure (difference −4·1 mm Hg, −7·8 to −0·4; p=0·0292). Evaluation of hourly changes in 24 h systolic blood pressure and diastolic blood pressure showed blood pressure reduction throughout 24 h for the renal denervation group. 3 month blood pressure reductions were not significantly different between groups. Medication adherence was about 60% and varied for individual patients throughout the study. No major adverse events were recorded in either group. Interpretation: Renal denervation in the main renal arteries and branches significantly reduced blood pressure compared with sham control with no major safety events. Incomplete medication adherence was common. Funding: Medtronic. © 2018 Elsevier Ltd

Published
2018

46. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial

Author

Townsend, RR, Mahfoud, F, Kandzari, DE, Kario, K, Pocock, S, Weber, MA, Ewen, S, Tsioufis, K, Tousoulis, D, Sharp, ASP, Watkinson, AF, Schmieder, RE, Schmid, A, Choi, JW, East, C, Walton, A, Hopper, I, Cohen, DL, Wilensky, R, Lee, DP, Ma, A, Devireddy, CM, Lea, JP, Lurz, PC, Fengler, K, Davies, J, Chapman, N, Cohen, SA, DeBruin, V, Fahy, M, Jones, DE, Rothman, M, Böhm, M, SPYRAL HTN-OFF MED trial investigators, COLLABORATORS, Aoki, J, Batson, B, Dangas, G, David, S, Kandzari, D, Patel, M, Patel, K, Singh, J, Weber, T, Weil, J, Zeller, T, Ziada, K, Tanabe, K, Wilkins, R, Contreras, J, Steigerwalt, S, Reedus, D, Hoshide, S, Svetkey, L, Rao, A, Brown, A, Suppan, M, Agdirlioglu, T, Noory, E, and Chasen, C

Abstract

Previous randomised renal denervation studies did not show consistent efficacy in reducing blood pressure. The objective of our study was to evaluate the effect of renal denervation on blood pressure in the absence of antihypertensive medications. SPYRAL HTN-OFF MED was a multicentre, international, single-blind, randomised, sham-controlled, proof-of-concept trial. Patients were enrolled at 21 centres in the USA, Europe, Japan, and Australia. Eligible patients were drug-naive or discontinued their antihypertensive medications. Patients with an office systolic blood pressure (SBP) of 150 mm Hg or greater and less than 180 mm Hg, office diastolic blood pressure (DBP) of 90 mm Hg or greater, and a mean 24-h ambulatory SBP of 140 mm Hg or greater and less than 170 mm Hg at second screening underwent renal angiography and were randomly assigned to renal denervation or sham control. Patients, caregivers, and those assessing blood pressure were blinded to randomisation assignments. The primary endpoint, change in 24-h blood pressure at 3 months, was compared between groups. Drug surveillance was done to ensure patient compliance with absence of antihypertensive medication. The primary analysis was done in the intention-to-treat population. Safety events were assessed at 3 months. This study is registered with ClinicalTrials.gov, number NCT02439749. Between June 25, 2015, and Jan 30, 2017, 353 patients were screened. 80 patients were randomly assigned to renal denervation (n=38) or sham control (n=42) and followed up for 3 months. Office and 24-h ambulatory blood pressure decreased significantly from baseline to 3 months in the renal denervation group: 24-h SBP -5·5 mm Hg (95% CI -9·1 to -2·0; p=0·0031), 24-h DBP -4·8 mm Hg (-7·0 to -2·6; p

Published
2017

47. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial

Author

Townsend, R.R. Mahfoud, F. Kandzari, D.E. Kario, K. Pocock, S. Weber, M.A. Ewen, S. Tsioufis, K. Tousoulis, D. Sharp, A.S.P. Watkinson, A.F. Schmieder, R.E. Schmid, A. Choi, J.W. East, C. Walton, A. Hopper, I. Cohen, D.L. Wilensky, R. Lee, D.P. Ma, A. Devireddy, C.M. Lea, J.P. Lurz, P.C. Fengler, K. Davies, J. Chapman, N. Cohen, S.A. DeBruin, V. Fahy, M. Jones, D.E. Rothman, M. Böhm, M. Aoki, J. Batson, B. Dangas, G. David, S. Patel, M. Patel, K. Singh, J. Weber, T. Weil, J. Zeller, T. Ziada, K. Tanabe, K. Wilkins, R. Contreras, J. Steigerwalt, S. Reedus, D. Hoshide, S. Svetkey, L. Rao, A. Brown, A. Suppan, M. Agdirlioglu, T. Noory, E. Chasen, C. SPYRAL HTN-OFF MED trial investigators* SPYRAL HTN-OFF MED trial investigators

Abstract

Background Previous randomised renal denervation studies did not show consistent efficacy in reducing blood pressure. The objective of our study was to evaluate the effect of renal denervation on blood pressure in the absence of antihypertensive medications. Methods SPYRAL HTN-OFF MED was a multicentre, international, single-blind, randomised, sham-controlled, proof-of-concept trial. Patients were enrolled at 21 centres in the USA, Europe, Japan, and Australia. Eligible patients were drug-naive or discontinued their antihypertensive medications. Patients with an office systolic blood pressure (SBP) of 150 mm Hg or greater and less than 180 mm Hg, office diastolic blood pressure (DBP) of 90 mm Hg or greater, and a mean 24-h ambulatory SBP of 140 mm Hg or greater and less than 170 mm Hg at second screening underwent renal angiography and were randomly assigned to renal denervation or sham control. Patients, caregivers, and those assessing blood pressure were blinded to randomisation assignments. The primary endpoint, change in 24-h blood pressure at 3 months, was compared between groups. Drug surveillance was done to ensure patient compliance with absence of antihypertensive medication. The primary analysis was done in the intention-to-treat population. Safety events were assessed at 3 months. This study is registered with ClinicalTrials.gov, number NCT02439749. Findings Between June 25, 2015, and Jan 30, 2017, 353 patients were screened. 80 patients were randomly assigned to renal denervation (n=38) or sham control (n=42) and followed up for 3 months. Office and 24-h ambulatory blood pressure decreased significantly from baseline to 3 months in the renal denervation group: 24-h SBP −5·5 mm Hg (95% CI −9·1 to −2·0; p=0·0031), 24-h DBP −4·8 mm Hg (−7·0 to −2·6; p

Published
2017

49. Reduced blood pressure-lowering effect of catheter-based renal denervation in patients with isolated systolic hypertension: Data from SYMPLICITY HTN-3 and the Global SYMPLICITY Registry

Author

Mahfoud, F, Bakris, G, Bhatt, D, Esler, M, Ewen, S, Fahy, M, Kandzari, D, Kario, K, Mancia, G, Weber, M, Böhm, M, Bhatt, DL, Mahfoud, F, Bakris, G, Bhatt, D, Esler, M, Ewen, S, Fahy, M, Kandzari, D, Kario, K, Mancia, G, Weber, M, Böhm, M, and Bhatt, DL

Abstract

Aims Catheter-based renal artery denervation (RDN) has been shown to lower blood pressure (BP) in certain patients with uncontrolled hypertension. Isolated systolic hypertension (ISH) (systolic BP [SBP] ≥140 mmHg and diastolic BP ,90 mmHg), characterized by increased vascular stiffness, is the predominant hypertensive phenotype in elderly patients. This study compared baseline characteristics and SBP change at 6 months between patients with ISH and combined systolic-diastolic hypertension (CH). Methods and results This study pooled data from1103 patients from SYMPLICITY HTN-3 and the Global SYMPLICITY Registry. A total of 429 patients had ISH, and 674 had CH. Patients with ISH were significantly older than those with CH (66 vs. 55 years), had more type 2 diabetes mellitus (52.9 vs. 34.6%), and a lower estimated glomerular filtration rate (71.8 vs. 78.6 mL/min/ 1.73 m2); all P , 0.001. At 6 months, the SBP drop for CH patients was 218.7+23.7 mmHg compared with a reduction of 210.9+21.7 mmHg for ISH patients 27.8 mmHg, 95% confidence interval, CI, 210.5, 25.1, P , 0.001). The change in 24-h SBP at 6 months was 28.8+16.2 mmHg in patients with CH vs. 25.8+15.4 mmHg in ISH (23.0 mmHg, 95% CI 25.4, 20.6, P = 0.015). Presence of ISH at baseline but not age was associated with less pronounced BP changes following the procedure. The strongest predictor of office SBP reduction at 6 months was CH, followed by aldosterone antagonist use and non-use of vasodilators. Conclusion The reduction in BP among patients with ISH following RDNwas less pronounced than the reduction in patientswith CH.

Published
2017

50. Improvement in health-related quality of life after renal sympathetic denervation in real-world hypertensive patients: 12-month outcomes in the Global SYMPLICITY Registry

Author

Kindermann, I, Wedegärtner, S, Mahfoud, F, Weil, J, Brilakis, N, Ukena, J, Ewen, S, Linz, D, Fahy, M, Mancia, G, Böhm, M, Wedegärtner, SM, Böhm, M., MANCIA, GIUSEPPE, Kindermann, I, Wedegärtner, S, Mahfoud, F, Weil, J, Brilakis, N, Ukena, J, Ewen, S, Linz, D, Fahy, M, Mancia, G, Böhm, M, Wedegärtner, SM, Böhm, M., and MANCIA, GIUSEPPE

Abstract

Renal denervation has been shown to reduce blood pressure in patients with uncontrolled hypertension, but less is known about its impact on quality of life. This analysis evaluated 12-month blood pressure and quality of life outcomes in 934 patients from the Global SYMPLICITY Registry who completed the EuroQoL five-dimensions three-level questionnaire (EQ-5D-3L). At baseline, 32% of patients reported anxiety/depression and 48% reported pain/discomfort. At 12 months (n=496), office and 24-hour ambulatory systolic blood pressure were reduced by 13.9±26.6 and 7.7±19.3 mm Hg, respectively, and 8% (P<.001) more patients reported no problems in anxiety/depression. Furthermore, numerically more patients reported no problems in pain/discomfort (4%, P=.08). Perceived health-related quality of life (visual analog scale) improved from baseline to 12 months (68±18 vs 73±17, P<.001), and the improvement was largest among patients with severe anxiety/depression at baseline (50±24 vs 64±22, P=.005 [n=32]). In this analysis, renal denervation was associated with a significant improvement in health-related quality of life, particularly anxiety/depression.

Published
2017

Catalog

Books, media, physical & digital resources
See catalog results