75 results on '"Rocha-Singh K"'
Search Results
2. Predictors of blood pressure response in the SYMPLICITY HTN-3 trial
- Author
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Kandzari, D. E., primary, Bhatt, D. L., additional, Brar, S., additional, Devireddy, C. M., additional, Esler, M., additional, Fahy, M., additional, Flack, J. M., additional, Katzen, B. T., additional, Lea, J., additional, Lee, D. P., additional, Leon, M. B., additional, Ma, A., additional, Massaro, J., additional, Mauri, L., additional, Oparil, S., additional, O'Neill, W. W., additional, Patel, M. R., additional, Rocha-Singh, K., additional, Sobotka, P. A., additional, Svetkey, L., additional, Townsend, R. R., additional, and Bakris, G. L., additional
- Published
- 2014
- Full Text
- View/download PDF
3. International expert consensus statement: percutaneous transluminal renal denervation for the treatment of resistant hypertension
- Author
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Schlaich, M, Schmieder, R, Bakris, G, Blankestijn, P, Böhm, M, Campese, V, Francis, D, Grassi, G, Hering, D, Katholi, R, Kjeldsen, S, Krum, H, Mahfoud, F, Mancia, G, Messerli, F, Narkiewicz, K, Parati, G, Rocha Singh, K, Ruilope, L, Rump, L, Sica, D, Sobotka, P, Tsioufis, C, Vonend, O, Weber, M, Williams, B, Zeller, T, Esler, M, Schlaich, MP, Schmieder, RE, Blankestijn, PJ, Campese, VM, Francis, DP, GRASSI, GUIDO, MANCIA, GIUSEPPE, Messerli, FH, PARATI, GIANFRANCO, Rocha Singh, KJ, Ruilope, LM, Rump, LC, Sica, DA, Sobotka, PA, Weber, MA, Esler, MD, Schlaich, M, Schmieder, R, Bakris, G, Blankestijn, P, Böhm, M, Campese, V, Francis, D, Grassi, G, Hering, D, Katholi, R, Kjeldsen, S, Krum, H, Mahfoud, F, Mancia, G, Messerli, F, Narkiewicz, K, Parati, G, Rocha Singh, K, Ruilope, L, Rump, L, Sica, D, Sobotka, P, Tsioufis, C, Vonend, O, Weber, M, Williams, B, Zeller, T, Esler, M, Schlaich, MP, Schmieder, RE, Blankestijn, PJ, Campese, VM, Francis, DP, GRASSI, GUIDO, MANCIA, GIUSEPPE, Messerli, FH, PARATI, GIANFRANCO, Rocha Singh, KJ, Ruilope, LM, Rump, LC, Sica, DA, Sobotka, PA, Weber, MA, and Esler, MD
- Abstract
Catheter-based radiofrequency ablation technology to disrupt both efferent and afferent renal nerves has recently been introduced to clinical medicine after the demonstration of significant systolic and diastolic blood pressure reductions. Clinical trial data available thus far have been obtained primarily in patients with resistant hypertension, defined as standardized systolic clinic blood pressure ≥160 mm Hg (or ≥150 mm Hg in patients with type 2 diabetes) despite appropriate pharmacologic treatment with at least 3 antihypertensive drugs, including a diuretic agent. Accordingly, these criteria and blood pressure thresholds should be borne in mind when selecting patients for renal nerve ablation. Secondary forms of hypertension and pseudoresistance, such as nonadherence to medication, intolerance of medication, and white coat hypertension, should have been ruled out, and 24-h ambulatory blood pressure monitoring is mandatory in this context. Because there are theoretical concerns with regard to renal safety, selected patients should have preserved renal function, with an estimated glomerular filtration rate ≥45 ml/min/1.73 m(2). Optimal periprocedural management of volume status and medication regimens at specialized and experienced centers equipped with adequate infrastructure to cope with potential procedural complications will minimize potential patient risks. Long-term safety and efficacy data are limited to 3 years of follow-up in small patient cohorts, so efforts to monitor treated patients are crucial to define the long-term performance of the procedure. Although renal nerve ablation could have beneficial effects in other conditions characterized by elevated renal sympathetic nerve activity, its potential use for such indications should currently be limited to formal research studies of its safety and efficacy.
- Published
- 2013
4. Catheter-based renal sympathetic denervation reduces systolic blood pressure by 32 mm Hg in people with treatment-resistant hypertension
- Author
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Katholi, R. E., primary and Rocha-Singh, K. J., additional
- Published
- 2011
- Full Text
- View/download PDF
5. Results of intracoronary recombinant human vascular endothelial growth factor (rhVEGF) administration trial
- Author
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Henry, T.D., primary, Rocha-Singh, K., additional, Isner, J.M., additional, Kereiakes, D.J., additional, Giordano, F.J., additional, Simons, M., additional, Losordo, D.W., additional, Hendel, R.C., additional, Bonow, R.O., additional, Rothman, J.M., additional, Borbas, E.R., additional, and McCluskey, E.R., additional
- Published
- 1998
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6. Concanavalin A amplifies both beta-adrenergic and muscarinic cholinergic receptor-adenylate cyclase-linked pathways in cardiac myocytes.
- Author
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Rocha-Singh, K J, primary, Hines, D K, additional, Honbo, N Y, additional, and Karliner, J S, additional
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- 1991
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7. 1 Adrenoceptor mediated signal transduction in neonatal rat ventricular myocytes: effects of prolonged hypoxia and reoxygenation
- Author
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Kagiya, T., primary, Rocha-Singh, K. J, additional, Honbo, N., additional, and Karliner, J. S, additional
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- 1991
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8. Hypoxia and glucose independently regulate the beta-adrenergic receptor-adenylate cyclase system in cardiac myocytes.
- Author
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Rocha-Singh, K J, primary, Honbo, N Y, additional, and Karliner, J S, additional
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- 1991
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9. Embolic protection and platelet inhibition during renal artery stenting.
- Author
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Cooper CJ, Haller ST, Colyer W, Steffes M, Burket MW, Thomas WJ, Safian R, Reddy B, Brewster P, Ankenbrandt MA, Virmani R, Dippel E, Rocha-Singh K, Murphy TP, Kennedy DJ, Shapiro JI, D'Agostino RD, Pencina MJ, and Khuder S
- Published
- 2008
10. Effect of intracoronary recombinant human vascular endothelial growth factor on myocardial perfusion: evidence for a dose-dependent effect.
- Author
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Hendel, R C, Henry, T D, Rocha-Singh, K, Isner, J M, Kereiakes, D J, Giordano, F J, Simons, M, and Bonow, R O
- Published
- 2000
11. Evaluation of the Safety and Effectiveness of Renal Artery Stenting After Unsuccessful Balloon Angioplasty: The ASPIRE-2 Study
- Author
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Rocha-Singh, K., Jaff, M.R., and Rosenfield, K.
- Published
- 2006
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12. Evaluation of the Safety and Effectiveness of Renal Artery Stenting After Unsuccessful Balloon Angioplasty. The ASPIRE-2 Study
- Author
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Rocha-Singh, K., Jaff, M.R., and Rosenfield, K.
- Published
- 2005
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13. Hypercalcemia, nausea, years of bloody diarrhea
- Author
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Jacobson Ej, Rocha-Singh K, and Asbill Mc
- Subjects
Diarrhea ,Male ,Pediatrics ,medicine.medical_specialty ,Nausea ,business.industry ,General Medicine ,Middle Aged ,Chronic Disease ,medicine ,Dysentery, Amebic ,Hypercalcemia ,Humans ,Bloody diarrhea ,medicine.symptom ,business ,Gastrointestinal Hemorrhage - Published
- 1984
14. Hypercalcemia, Nausea, Years of Bloody Diarrhea
- Author
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Asbill, M. C., primary, Rocha-Singh, K., additional, and Jacobson, E. J., additional
- Published
- 1984
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15. Frequency and Nonsurgical Therapy of Femoral Artery Pseudoaneurysm Complicating Interventional Cardiology Procedures
- Author
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Rocha-Singh, K. J., Schwend, R. B., Otis, S. M., and Schatz, R. A.
- Published
- 1994
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16. Design of the therapeutic angiogenesis with recombinant fibroblast growth factor-2 for intermittent claudication (TRAFFIC) trial.
- Author
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Lederman, Robert J., Tenaglia, Alan N., Anderson, R. David, Hermiller, James B., Rocha-Singh, Krishna, Mendelsohn, Farrell O., Hiatt, William R., Moon, Thomas, Whitehouse, M.J., Annex, Brian H., Lederman, R J, Tenaglia, A N, Anderson, R D, Hermiller, J B, Rocha-Singh, K, Mendelsohn, F O, Hiatt, W R, Moon, T, and Annex, B H
- Subjects
- *
BLOOD vessels , *NEOVASCULARIZATION , *GROWTH factors , *RECOMBINANT proteins , *CLINICAL trials , *COMPARATIVE studies , *EXPERIMENTAL design , *INTERMITTENT claudication , *RESEARCH methodology , *MEDICAL cooperation , *RESEARCH , *EVALUATION research , *RANDOMIZED controlled trials , *BLIND experiment , *THERAPEUTICS - Abstract
The Therapeutic Angiogenesis With Recombinant Fibroblast Growth Factor-2 for Intermittent Claudication (TRAFFIC) is a large, randomized, placebo-controlled, regimen-finding trial of intra-arterial recombinant fibroblast growth factor-2 in patients with intermittent claudication. This report describes the major design considerations and end points in TRAFFIC. [ABSTRACT FROM AUTHOR]
- Published
- 2001
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17. International expert consensus statement: Percutaneous transluminal renal denervation for the treatment of resistant hypertension
- Author
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Schlaich, Markus P., Schmieder, Roland E., Bakris, George, Blankestijn, Peter J., Böhm, Michael, Campese, Vito M., Francis, Darrel P., Grassi, Guido, Hering, Dagmara, Katholi, Richard, Kjeldsen, Sverre, Krum, Henry, Mahfoud, Felix, Mancia, Giuseppe, Messerli, Franz H., Narkiewicz, Krzysztof, Parati, Gianfranco, Rocha-Singh, Krishna J., Ruilope, Luis M., Rump, Lars C., Sica, Domenic A., Sobotka, Paul A., Tsioufis, Costas, Vonend, Oliver, Weber, Michael A., Williams, Bryan, Zeller, Thomas, Esler, Murray D., Schlaich, M, Schmieder, R, Bakris, G, Blankestijn, P, Böhm, M, Campese, V, Francis, D, Grassi, G, Hering, D, Katholi, R, Kjeldsen, S, Krum, H, Mahfoud, F, Mancia, G, Messerli, F, Narkiewicz, K, Parati, G, Rocha Singh, K, Ruilope, L, Rump, L, Sica, D, Sobotka, P, Tsioufis, C, Vonend, O, Weber, M, Williams, B, Zeller, T, and Esler, M
- Subjects
estimated glomerular filtration rate ,NE ,Kidney ,norepinephrine ,radiofrequency ,BP ,Renal Artery ,MSNA ,ABPM ,RDN ,eGFR ,Humans ,atrial fibrillation ,renal denervation ,pulmonary vein isolation ,muscle sympathetic nerve activity ,Patient Selection ,blood pressure ,resistant hypertension ,Anticoagulants ,sympathetic ,AF ,Denervation ,ambulatory blood pressure monitoring ,Hypertension ,Catheter Ablation ,RF ,PVI ,Platelet Aggregation Inhibitors ,Glomerular Filtration Rate - Abstract
Catheter-based radiofrequency ablation technology to disrupt both efferent and afferent renal nerves has recently been introduced to clinical medicine after the demonstration of significant systolic and diastolic blood pressure reductions. Clinical trial data available thus far have been obtained primarily in patients with resistant hypertension, defined as standardized systolic clinic blood pressure≥160 mm Hg (or≥150 mm Hg in patients with type 2 diabetes) despite appropriate pharmacologic treatment with at least 3 antihypertensive drugs, including a diuretic agent. Accordingly, these criteria and blood pressure thresholds should be borne in mind when selecting patients for renal nerve ablation. Secondary forms of hypertension and pseudoresistance, such as nonadherence to medication, intolerance of medication, and white coat hypertension, should have been ruled out, and 24-h ambulatory blood pressure monitoring is mandatory in this context. Because there are theoretical concerns with regard to renal safety, selected patients should have preserved renal function, with an estimated glomerular filtration rate≥45 ml/min/1.73 m(2). Optimal periprocedural management of volume status and medication regimens at specialized and experienced centers equipped with adequate infrastructure to cope with potential procedural complications will minimize potential patient risks. Long-term safety and efficacy data are limited to 3 years of follow-up in small patient cohorts, so efforts to monitor treated patients are crucial to define the long-term performance of the procedure. Although renal nerve ablation could have beneficial effects in other conditions characterized by elevated renal sympathetic nerve activity, its potential use for such indications should currently be limited to formal research studies of its safety and efficacy.
- Published
- 2013
18. Endovascular Ablation of the Greater Splanchnic Nerve in Heart Failure With Preserved Ejection Fraction: The REBALANCE-HF Randomized Clinical Trial.
- Author
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Fudim M, Borlaug BA, Mohan RC, Price MJ, Fail P, Goyal P, Hummel SL, Zirakashvili T, Shaburishvili T, Patel RB, Reddy VY, Nielsen CD, Chetcuti SJ, Sukul D, Gulati R, Kim L, Benzuly K, Mitter SS, Klein L, Uriel N, Augostini RS, Blair JE, Rocha-Singh K, Burkhoff D, Patel MR, Somo SI, Litwin SE, and Shah SJ
- Abstract
Importance: Greater splanchnic nerve ablation may improve hemodynamics in patients with heart failure and preserved ejection fraction (HFpEF)., Objective: To explore the feasibility and safety of endovascular right-sided splanchnic nerve ablation for volume management (SAVM)., Design, Setting, and Participants: This was a phase 2, double-blind, 1:1, sham-controlled, multicenter, randomized clinical trial conducted at 14 centers in the US and 1 center in the Republic of Georgia. Patients with HFpEF, left ventricular ejection fraction of 40% or greater, and invasively measured peak exercise pulmonary capillary wedge pressure (PCWP) of 25 mm Hg or greater were included. Study data were analyzed from May 2023 to June 2024., Intervention: SAVM vs sham control procedure., Main Outcomes and Measures: The primary efficacy end point was a reduction in legs-up and exercise PCWP at 1 month. The primary safety end point was serious device- or procedure-related adverse events at 1 month. Secondary efficacy end points included HF hospitalizations, changes in exercise function and health status through 12 months, and baseline to 1-month change in resting, legs-up, and 20-W exercise PCWP., Results: A total of 90 patients (median [range] age, 71 [47-90] years; 58 female [64.4%]) were randomized at 15 centers (44 SAVM vs 46 sham). There were no differences in adverse events between groups. The primary efficacy end point did not differ between SAVM or sham (mean between-group difference in PCWP, -0.03 mm Hg; 95% CI, -2.5 to 2.5 mm Hg; P = .95). There were also no differences in the secondary efficacy end points. There was no difference in the primary safety end point between the treatment (6.8% [3 of 44]) and sham (2.2% [1 of 46]) groups (difference, 4.6%; 95% CI, -6.1% to 15.4%; P = .36). There was no difference in the incidence of orthostatic hypotension between the treatment (11.4% [5 of 44]) and sham (6.5% [3 of 46]) groups (difference, 4.9%; 95% CI, -9.2% to 18.8%; P = .48)., Conclusions and Relevance: Results show that SAVM was safe and technically feasible, but it did not reduce exercise PCWP at 1 month or improve clinical outcomes at 12 months in a broad population of patients with HFpEF., Trial Registration: ClinicalTrials.gov Identifier: NCT04592445.
- Published
- 2024
- Full Text
- View/download PDF
19. Long-term outcomes after catheter-based renal artery denervation for resistant hypertension: final follow-up of the randomised SYMPLICITY HTN-3 Trial.
- Author
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Bhatt DL, Vaduganathan M, Kandzari DE, Leon MB, Rocha-Singh K, Townsend RR, Katzen BT, Oparil S, Brar S, DeBruin V, Fahy M, and Bakris GL
- Subjects
- Adult, Female, Humans, Male, Middle Aged, Antihypertensive Agents therapeutic use, Blood Pressure physiology, Catheters, Denervation methods, Diuretics therapeutic use, Follow-Up Studies, Kidney surgery, Kidney blood supply, Single-Blind Method, Sympathectomy methods, Treatment Outcome, Hypertension surgery, Hypertension drug therapy, Renal Artery surgery
- Abstract
Background: The SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) trial showed the safety but not efficacy of the Symplicity system (Medtronic, Santa Rosa, CA, USA) at 6 months follow-up in patients with treatment-resistant hypertension. This final report presents the 36-month follow-up results., Methods: SYMPLICITY HTN-3 was a single-blind, multicentre, sham-controlled, randomised clinical trial, done in 88 centres in the USA. Adults aged 18-80 years, with treatment-resistant hypertension on stable, maximally tolerated doses of three or more drugs including a diuretic, who had a seated office systolic blood pressure of 160 mm Hg or more and 24 h ambulatory systolic blood pressure of 135 mm Hg or more were randomly assigned (2:1) to receive renal artery denervation using the single electrode (Flex) catheter or a sham control. The original primary endpoint was the change in office systolic blood pressure from baseline to 6 months for the renal artery denervation group compared with the sham control group. Patients were unmasked after the primary endpoint assessment at 6 months, at which point eligible patients in the sham control group who met the inclusion criteria (office blood pressure ≥160 mm Hg, 24 h ambulatory systolic blood pressure ≥135 mm Hg, and still prescribed three or more antihypertensive medications) could cross over to receive renal artery denervation. Changes in blood pressure up to 36 months were analysed in patients in the original renal artery denervation group and sham control group, including those who underwent renal artery denervation after 6 months (crossover group) and those who did not (non-crossover group). For comparisons between the renal artery denervation and sham control groups, follow-up blood pressure values were imputed for patients in the crossover group using their most recent pre-crossover masked blood pressure value. We report long-term blood pressure changes in renal artery denervation and sham control groups, and investigate blood pressure control in both groups using time in therapeutic blood pressure range analysis. The primary safety endpoint was the incidence of all-cause mortality, end stage renal disease, significant embolic event, renal artery perforation or dissection requiring intervention, vascular complications, hospitalisation for hypertensive crisis unrelated to non-adherence to medications, or new renal artery stenosis of more than 70% within 6 months. The trial is registered with ClinicalTrials.gov, NCT01418261., Findings: From Sep 29, 2011, to May 6, 2013, 1442 patients were screened, of whom 535 (37%; 210 [39%] women and 325 [61%] men; mean age 57·9 years [SD 10·7]) were randomly assigned: 364 (68%) patients received renal artery denervation (mean age 57·9 years [10·4]) and 171 (32%) received the sham control (mean age 56·2 years [11·2]). 36-month follow-up data were available for 219 patients (original renal artery denervation group), 63 patients (crossover group), and 33 patients (non-crossover group). At 36 months, the change in office systolic blood pressure was -26·4 mm Hg (SD 25·9) in the renal artery denervation group and -5·7 mm Hg (24·4) in the sham control group (adjusted treatment difference -22·1 mm Hg [95% CI -27·2 to -17·0]; p≤0·0001). The change in 24 h ambulatory systolic blood pressure at 36 months was -15·6 mm Hg (SD 20·8) in the renal artery denervation group and -0·3 mm Hg (15·1) in the sham control group (adjusted treatment difference -16·5 mm Hg [95% CI -20·5 to -12·5]; p≤0·0001). Without imputation, the renal artery denervation group spent a significantly longer time in therapeutic blood pressure range (ie, better blood pressure control) than patients in the sham control group (18% [SD 25·0] for the renal artery denervation group vs 9% [SD 18·8] for the sham control group; p≤0·0001) despite a similar medication burden, with consistent and significant results with imputation. Rates of adverse events were similar across treatment groups, with no evidence of late-emerging complications from renal artery denervation. The rate of the composite safety endpoint to 48 months, including all-cause death, new-onset end-stage renal disease, significant embolic event resulting in end-organ damage, vascular complication, renal artery re-intervention, and hypertensive emergency was 15% (54 of 352 patients) for the renal artery denervation group, 14% (13 of 96 patients) for the crossover group, and 14% (10 of 69 patients) for the non-crossover group., Interpretation: This final report of the SYMPLICITY HTN-3 trial adds to the totality of evidence supporting the safety of renal artery denervation to 36 months after the procedure. From 12 months to 36 months after the procedure, patients who were originally randomly assigned to receive renal artery denervation had larger reductions in blood pressure and better blood pressure control compared with patients who received sham control., Funding: Medtronic., Competing Interests: Declaration of interests DLB served as the co-principal investigator of SYMPLICITY HTN-3 with funding from Medtronic paid to Brigham and Women's Hospital. DLB reports acting on advisory boards for AngioWave, Bayer, Boehringer Ingelheim, Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, High Enroll, Janssen, Level Ex, McKinsey, Medscape Cardiology, Merck, MyoKardia, NirvaMed, Novo Nordisk, PhaseBio, PLx Pharma, Regado Biosciences, and Stasys; is a member of the Board of Directors of AngioWave (stock options), Boston VA Research Institute, Bristol Myers Squibb (stock), DRS.LINQ (stock options), High Enroll (stock), Society of Cardiovascular Patient Care, and TobeSoft; is the Inaugural Chair of the American Heart Association Quality Oversight Committee; has consulted for Broadview Ventures; is a member of Data Monitoring Committees for Acesion Pharma, Assistance Publique-Hôpitaux de Paris, Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St Jude Medical, now Abbott), Boston Scientific, Cleveland Clinic, Contego Medical, Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine, Novartis, and Population Health Research Institute; Rutgers University; honoraria from the American College of Cardiology, Arnold and Porter law firm (work related to Sanofi/Bristol-Myers Squibb clopidogrel litigation), and Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute); is a member of the RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; is a member of the AEGIS-II executive committee (funded by CSL Behring), Belvoir Publications, Canadian Medical and Surgical Knowledge Translation Research Group, Cowen and Company, Duke Clinical Research Institute, HMP Global, Journal of the American College of Cardiology, K2P, Level Ex, Medtelligence/ReachMD, MJH Life Sciences, Oakstone CME, Piper Sandler, Population Health Research Institute, Slack Publications, Society of Cardiovascular Patient Care, WebMD, and Wiley; is the deputy editor of Clinical Cardiology; the chair of NCDR-ACTION Registry Steering Committee, and VA CART Research and Publications Committee; holds a patent on sotagliflozin (patent application 17/574,977); is named on a patent for sotagliflozin assigned to Brigham and Women's Hospital who assigned to Lexicon (neither DLB nor Brigham and Women's Hospital receive any income from this patent); research funding from Abbott, Acesion Pharma, Afimmune, Aker Biomarine, Amarin, Amgen, AstraZeneca, Bayer, Beren, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, CSL Behring, Eisai, Ethicon, Faraday Pharmaceuticals, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Garmin, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Javelin, Lexicon, Lilly, Medtronic, Merck, Moderna, MyoKardia, NirvaMed, Novartis, Novo Nordisk, Owkin, Pfizer, PhaseBio, PLx Pharma, Recardio, Regeneron, Reid Hoffman Foundation, Roche, Sanofi, Stasys, Synaptic, The Medicines Company, and 89Bio; reports royalties from Elsevier for Braunwald's Heart Disease; is a site co-investigator for Abbott, Biotronik, Boston Scientific, CSI, Endotronix, St Jude Medical (now Abbott), Philips, SpectraWAVE, Svelte, and Vascular Solutions; is a trustee of the American College of Cardiology; and reports unfunded research from FlowCo and Takeda. MV reports research grant support from or served on advisory boards for American Regent, Amgen, AstraZeneca, Bayer, Baxter Healthcare, Boehringer Ingelheim, Cytokinetics, Lexicon Pharmaceuticals, Novartis, Pharmacosmos, Relypsa, Roche Diagnostics, Sanofi, and Tricog Health; speaker engagements with AstraZeneca, Novartis, and Roche Diagnostics; and participates on clinical trial committees for studies sponsored by Galmed, Novartis, Bayer AG, Occlutech, and Impulse Dynamics. DEK reports institutional research or grant support from Medtronic and Ablative Solutions, and personal consulting honoraria from Medtronic. MBL reports institutional research support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; and has served on consulting or advisory boards for Medtronic, Boston Scientific, Gore, Meril Lifescience, and Abbott. SB, VD, and MF are employees of Medtronic. KR-S is a consultant for Alucent Biomedical. RRT reports grant support from the National Institutes of Health and consultant fees from Medtronic and JanssenMD; travel support from the American Society of Nephrology, North American Artery, and the National Kidney Foundation; and royalties from UpToDate. BTK is Chief Medical Executive and member of the steering committee for Medtronic Vascular. SO has received grant support from Medtronic, Merck, and Bayer; and personal fees from Medtronic, Daiichi Sankyo, and Bayer. GLB is supported by T32 National Institutes of Health grant DK07011 and is a consultant to Bayer, KBP Biosciences, Ionis, Alnylam, AstraZeneca, Quantum Genomics, Novo Nordisk, Dia Medica Therapeutics, and InREGEN; and is the Editor of the American Journal of Nephrology., (Copyright © 2022 Elsevier Ltd. All rights reserved.)
- Published
- 2022
- Full Text
- View/download PDF
20. Endovascular ablation of the right greater splanchnic nerve in heart failure with preserved ejection fraction: early results of the REBALANCE-HF trial roll-in cohort.
- Author
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Fudim M, Fail PS, Litwin SE, Shaburishvili T, Goyal P, Hummel SL, Borlaug BA, Mohan RC, Patel RB, Mitter SS, Klein L, Rocha-Singh K, Patel MR, Reddy VY, Burkhoff D, and Shah SJ
- Subjects
- Aged, Female, Humans, Male, Pulmonary Wedge Pressure, Splanchnic Nerves, Stroke Volume, Ventricular Function, Left, Heart Failure surgery
- Abstract
Aims: In heart failure (HF) with preserved ejection fraction (HFpEF), excessive redistribution of blood volume into the central circulation leads to elevations of intracardiac pressures with exercise limitations. Splanchnic ablation for volume management (SAVM) has been proposed as a therapeutic intervention. Here we present preliminary safety and efficacy data from the initial roll-in cohort of the REBALANCE-HF trial., Methods and Results: The open-label (roll-in) arm of REBALANCE-HF will enrol up to 30 patients, followed by the randomized, sham-controlled portion of the trial (up to 80 additional patients). Patients with HF, left ventricular ejection fraction (LVEF) ≥50%, and invasive peak exercise pulmonary capillary wedge pressure (PCWP) ≥25 mmHg underwent SAVM. Baseline and follow-up assessments included resting and exercise PCWP, New York Heart Association (NYHA) class, Kansas City Cardiomyopathy Questionnaire (KCCQ), 6-min walk test, and N-terminal pro-B-type natriuretic peptide (NT-proBNP). Efficacy and safety were assessed at 1 and 3 months. Here we report on the first 18 patients with HFpEF that have been enrolled into the roll-in, open-label arm of the study across nine centres; 14 (78%) female; 16 (89%) in NYHA class III; and median (interquartile range) age 75.2 (68.4-81) years, LVEF 61.0 (56.0-63.2)%, and average (standard deviation) 20 W exercise PCWP 36.4 (±8.6) mmHg. All 18 patients were successfully treated. Three non-serious moderate device/procedure-related adverse events were reported. At 1-month, the mean PCWP at 20 W exercise decreased from 36.4 (±8.6) to 28.9 (±7.8) mmHg (p < 0.01), NYHA class improved by at least one class in 33% of patients (p = 0.02) and KCCQ score improved by 22.1 points (95% confidence interval 9.4-34.2) (p < 0.01)., Conclusion: The preliminary open-label results from the multicentre REBALANCE-HF roll-in cohort support the safety and efficacy of SAVM in HFpEF. The findings require confirmation in the ongoing randomized, sham-controlled portion of the trial., (© 2022 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)
- Published
- 2022
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- View/download PDF
21. Retrograde Tibioperoneal Access to Treat Complex Infrainguinal Disease: An Advanced Technique in Search of Advanced Technology.
- Author
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Rocha-Singh K
- Subjects
- Humans, Treatment Outcome, Limb Salvage, Peripheral Arterial Disease
- Published
- 2019
- Full Text
- View/download PDF
22. Drug-Coated Balloon Treatment of Femoropopliteal Lesions Typically Excluded From Clinical Trials: 12-Month Findings From the IN.PACT Global Study.
- Author
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Ansel GM, Brodmann M, Keirse K, Micari A, Jaff MR, Rocha-Singh K, Fernandez EJ, Wang H, and Zeller T
- Subjects
- Aged, Angioplasty, Balloon adverse effects, Equipment Design, Female, Humans, Male, Middle Aged, Peripheral Arterial Disease diagnostic imaging, Peripheral Arterial Disease physiopathology, Progression-Free Survival, Randomized Controlled Trials as Topic, Retrospective Studies, Time Factors, Vascular Patency, Angioplasty, Balloon instrumentation, Coated Materials, Biocompatible, Femoral Artery diagnostic imaging, Femoral Artery physiopathology, Patient Selection, Peripheral Arterial Disease therapy, Popliteal Artery diagnostic imaging, Popliteal Artery physiopathology, Vascular Access Devices
- Abstract
Purpose: To report a post hoc analysis comparing outcomes between subjects who would have been included in the IN.PACT SFA randomized controlled trial vs those who would have been excluded., Methods: The 1406 subjects enrolled in the IN.PACT Global Study ( ClinicalTrials.gov identifier NCT01609296) were retrospectively assigned to a standard-use group (n=281) based on the inclusion and exclusion criteria from the randomized IN.PACT SFA trial; the remaining 1125 patients were assigned to the broader-use group. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated at 12 months. The composite primary safety endpoint was freedom from 30-day device- and procedure-related death plus freedom from 12-month target limb major amputation and clinically-driven target vessel revascularization (CD-TVR). Functional outcomes were evaluated with dedicated questionnaires., Results: Compared with the standard-use cohort, the broader-use lesions were longer, more calcified, and had more popliteal involvement, bilateral disease, and in-stent restenosis (p<0.001 for all). Freedom from 12-month CD-TLR by Kaplan-Meier analysis was 96.6% for the standard-use group and 91.6% for the broader-use group (p=0.005). The safety endpoint was 96.2% in the standard-use group and 91.0% in the broader-use group (p=0.003). The 12-month CD-TLR (3.4% standard-use vs 8.5% broader-use, p=0.004) and CD-TVR (4.2% standard-use vs 9.1% broader-use, p=0.008) were increased in the broader-use group. Twelve-month all-cause mortality was not increased (3.8% standard-use vs 3.4% broader-use, p=0.852)., Conclusion: Post hoc analysis of the IN.PACT Global Study of real-world patients demonstrated consistent outcomes with significant clinical improvement to 12 months in subjects with complex lesions typically excluded from a randomized controlled trial.
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- 2018
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23. An analysis of the blood pressure and safety outcomes to renal denervation in African Americans and Non-African Americans in the SYMPLICITY HTN-3 trial.
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Flack JM, Bhatt DL, Kandzari DE, Brown D, Brar S, Choi JW, D'Agostino R, East C, Katzen BT, Lee L, Leon MB, Mauri L, O'Neill WW, Oparil S, Rocha-Singh K, Townsend RR, and Bakris G
- Subjects
- Adult, Black or African American, Aged, Antihypertensive Agents therapeutic use, Blood Pressure Monitoring, Ambulatory, Catheter Ablation, Cohort Studies, Female, Humans, Hypertension ethnology, Male, Medication Adherence, Middle Aged, Multivariate Analysis, Prospective Studies, Sympathectomy methods, Treatment Outcome, Hypertension physiopathology, Hypertension surgery, Kidney innervation, Sympathetic Nervous System surgery
- Abstract
SYMPLICITY HTN-3, the first trial of renal denervation (RDN) versus sham, enrolled 26% African Americans, a prospectively stratified cohort. Although the 6-month systolic blood pressure (SBP) reduction in African Americans (AAs) was similar in the RDN group (-15.5 ± 25.4 mm Hg, n = 85 vs. -17.8 ± 29.2, n = 49, P = .641), the sham SBP response was 9.2 mm Hg greater (P = .057) in AAs than non-AAs. In multivariate analyses, sham SBP response was predicted by an interaction between AA and a complex antihypertensive regimen (at least one antihypertensive medication prescribed ≥3 times daily), while in the RDN group, SBP response was predicted by an interaction between AA race and baseline BP ≥ 180 mm Hg. AA race did not independently predict SBP response in either sham or RDN. There appears to be effect modification by race with individual-level patient characteristics in both treatment arms that affect the observed pattern of SBP responses., (Copyright © 2015 American Society of Hypertension. Published by Elsevier Inc. All rights reserved.)
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- 2015
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24. Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease.
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Rosenfield K, Jaff MR, White CJ, Rocha-Singh K, Mena-Hurtado C, Metzger DC, Brodmann M, Pilger E, Zeller T, Krishnan P, Gammon R, Müller-Hülsbeck S, Nehler MR, Benenati JF, and Scheinert D
- Subjects
- Aged, Angioplasty, Balloon adverse effects, Diabetes Complications therapy, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Peripheral Arterial Disease mortality, Radiography, Single-Blind Method, Smoking, Vascular Patency, Angioplasty, Balloon instrumentation, Femoral Artery diagnostic imaging, Paclitaxel administration & dosage, Peripheral Arterial Disease therapy, Popliteal Artery diagnostic imaging
- Abstract
Background: The treatment of peripheral artery disease with percutaneous transluminal angioplasty is limited by the occurrence of vessel recoil and restenosis. Drug-coated angioplasty balloons deliver antiproliferative agents directly to the artery, potentially improving vessel patency by reducing restenosis., Methods: In this single-blind, randomized trial conducted at 54 sites, we assigned, in a 2:1 ratio, 476 patients with symptomatic intermittent claudication or ischemic pain while at rest and angiographically significant atherosclerotic lesions to angioplasty with a paclitaxel-coated balloon or to standard angioplasty. The primary efficacy end point was primary patency of the target lesion at 12 months (defined as freedom from binary restenosis or from the need for target-lesion revascularization). The primary safety end point was a composite of freedom from perioperative death from any cause and freedom at 12 months from limb-related death (i.e., death from a medical complication related to a limb), amputation, and reintervention., Results: The two groups were well matched at baseline; 42.9% of the patients had diabetes, and 34.7% were current smokers. At 12 months, the rate of primary patency among patients who had undergone angioplasty with the drug-coated balloon was superior to that among patients who had undergone conventional angioplasty (65.2% vs. 52.6%, P=0.02). The proportion of patients free from primary safety events was 83.9% with the drug-coated balloon and 79.0% with standard angioplasty (P=0.005 for noninferiority). There were no significant between-group differences in functional outcomes or in the rates of death, amputation, thrombosis, or reintervention., Conclusions: Among patients with symptomatic femoropopliteal peripheral artery disease, percutaneous transluminal angioplasty with a paclitaxel-coated balloon resulted in a rate of primary patency at 12 months that was higher than the rate with angioplasty with a standard balloon. The drug-coated balloon was noninferior to the standard balloon with respect to safety. (Funded by Lutonix-Bard; LEVANT 2 ClinicalTrials.gov number, NCT01412541.).
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- 2015
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25. 12-month blood pressure results of catheter-based renal artery denervation for resistant hypertension: the SYMPLICITY HTN-3 trial.
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Bakris GL, Townsend RR, Flack JM, Brar S, Cohen SA, D'Agostino R, Kandzari DE, Katzen BT, Leon MB, Mauri L, Negoita M, O'Neill WW, Oparil S, Rocha-Singh K, and Bhatt DL
- Subjects
- Adult, Aged, Blood Pressure Determination, Blood Pressure Monitoring, Ambulatory, Cross-Over Studies, Female, Follow-Up Studies, Humans, Male, Middle Aged, Prospective Studies, Treatment Outcome, Blood Pressure physiology, Catheterization methods, Hypertension surgery, Renal Artery innervation, Sympathectomy methods
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Background: Results of the SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) trial confirmed the safety but not the efficacy of renal denervation for treatment-resistant hypertension at 6 months post procedure., Objectives: This study sought to analyze the 12-month SYMPLICITY HTN-3 results for the original denervation group, the sham subjects who underwent denervation after the 6-month endpoint (crossover group), and the sham subjects who did not undergo denervation after 6 months (non-crossover group)., Methods: Eligible subjects were randomized 2:1 to denervation or sham procedure. Subjects were unblinded to their treatment group after the 6-month primary endpoint was ascertained; subjects in the sham group meeting eligibility requirements could undergo denervation. Change in blood pressure (BP) at 12 months post randomization (6 months for crossover subjects) was analyzed., Results: The 12-month follow-up was available for 319 of 361 denervation subjects and 48 of 101 non-crossover subjects; 6-month denervation follow-up was available for 93 of 101 crossover subjects. In denervation subjects, the 12-month office systolic BP (SBP) change was greater than that observed at 6 months (-15.5 ± 24.1 mm Hg vs. -18.9 ± 25.4 mm Hg, respectively; p = 0.025), but the 24-h SBP change was not significantly different at 12 months (p = 0.229). The non-crossover group office SBP decreased by -32.9 ± 28.1 mm Hg at 6 months, but this response regressed to -21.4 ± 19.9 mm Hg (p = 0.01) at 12 months, increasing to 11.5 ± 29.8 mm Hg., Conclusions: These data support no further reduction in office or ambulatory BP after 1-year follow-up. Loss of BP reduction in the non-crossover group may reflect decreased medication adherence or other related factors. (Renal Denervation in Patients With Uncontrolled Hypertension [SYMPLICITY HTN-3]; NCT01418261)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2015
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26. Drug-coated balloons to improve femoropopliteal artery patency: Rationale and design of the LEVANT 2 trial.
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Jaff MR, Rosenfield K, Scheinert D, Rocha-Singh K, Benenati J, Nehler M, and White CJ
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- Aged, Antineoplastic Agents, Phytogenic administration & dosage, Antineoplastic Agents, Phytogenic pharmacokinetics, Coated Materials, Biocompatible, Female, Femoral Artery physiopathology, Follow-Up Studies, Humans, Male, Paclitaxel pharmacokinetics, Peripheral Arterial Disease metabolism, Peripheral Arterial Disease physiopathology, Popliteal Artery physiopathology, Prospective Studies, Single-Blind Method, Treatment Outcome, Angioplasty, Balloon methods, Drug-Eluting Stents, Femoral Artery surgery, Paclitaxel administration & dosage, Peripheral Arterial Disease surgery, Popliteal Artery surgery, Vascular Patency physiology
- Abstract
Background: Atherosclerotic peripheral artery disease (PAD) is common and results in limitations in quality of life and potential progression to limb loss. Options for therapy include medical therapy, supervised exercise, surgical revascularization, and, more recently, endovascular therapies to restore arterial perfusion to the limb. Endovascular revascularization has evolved over the past 2 decades, from percutaneous transluminal angioplasty (PTA) to self-expanding stents, atherectomy, laser angioplasty, and drug-eluting stents. Despite impressive technologic advances, PTA remains the standard of care at many institutions and is the recommended primary treatment modality for femoral-popliteal PAD according to current American College of Cardiology Foundation/American Heart Association guidelines. However, restenosis after PTA is common. Therefore, a significant clinical need remains for a device that is able to achieve more durable patency than PTA but does not require a permanent implant. Drug-coated balloons (DCBs) have the potential to address this need. Several randomized controlled clinical trials of PTA balloons coated with different formulations of paclitaxel have been conducted in Europe (N Engl J Med 2008;358:689-699) (Circulation 2008;118:1358-1365) (Circ Cardiovasc Interv 2012;5:831-840) (JACC Cardiovas Interv 2014;7:10-19) and demonstrated more durable efficacy than PTA with comparable safety. These studies were limited by small sample sizes and powered solely for an angiographic primary end point. The pivotal LEVANT 2 trial was designed in collaboration with the US Food and Drug Administration to demonstrate safety and efficacy in a large population and to obtain US Food and Drug Administration approval., Methods: A prospective, multicenter, single-blind trial comparing the Lutonix DCB (Bard Lutonix; New Hope, MN) versus PTA for treatment of femoropopliteal PAD (LEVANT 2) is the first US-based 2:1 randomized controlled trial of 476 patients with femoral-popliteal PAD designed to demonstrate superior efficacy and noninferior safety of a novel paclitaxel DCB compared with PTA. The primary efficacy end point is primary patency at 12 months. The primary safety end point is composite freedom at 12 months from perioperative death, index limb amputation, reintervention, and limb-related mortality. A series of important secondary end points include physical functioning, quality of life, revascularizations, and alternative measures of patency. To minimize bias potential for confounding variables, LEVANT 2 (1) excluded patients stented after predilation before randomization, (2) incorporated very stringent criteria for bailout stenting, (3) did not count bailout stenting as a target lesion revascularization or failure of any end point, (4) required a blinded clinician to perform clinical evaluations at follow-up, and (5) required clinical assessment before review of duplex ultrasound results., Conclusions: LEVANT 2 represents the first US-inclusive multicenter, randomized controlled trial to assess the safety and efficacy of a novel DCB compared with PTA as primary therapy for symptomatic PAD on the background of standard medical therapy., (Copyright © 2014 Elsevier Inc. All rights reserved.)
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- 2015
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27. Predictors of blood pressure response in the SYMPLICITY HTN-3 trial.
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Kandzari DE, Bhatt DL, Brar S, Devireddy CM, Esler M, Fahy M, Flack JM, Katzen BT, Lea J, Lee DP, Leon MB, Ma A, Massaro J, Mauri L, Oparil S, O'Neill WW, Patel MR, Rocha-Singh K, Sobotka PA, Svetkey L, Townsend RR, and Bakris GL
- Subjects
- Adult, Blood Pressure physiology, Catheter Ablation methods, Chronic Disease, Female, Humans, Hypertension physiopathology, Male, Middle Aged, Treatment Outcome, Hypertension surgery, Kidney innervation, Sympathectomy methods
- Abstract
Aims: The SYMPLICITY HTN-3 randomized, blinded, sham-controlled trial confirmed the safety of renal denervation (RDN), but did not meet its primary efficacy endpoint. Prior RDN studies have demonstrated significant and durable reductions in blood pressure. This analysis investigated factors that may help explain these disparate results., Methods and Results: Patients with resistant hypertension were randomized 2 : 1 to RDN (n = 364) or sham (n = 171). The primary endpoint was the difference in office systolic blood pressure (SBP) change at 6 months. A multivariable analysis identified predictors of SBP change. Additional analyses examined the influence of medication changes, results in selected subgroups and procedural factors. Between randomization and the 6-month endpoint, 39% of patients underwent medication changes. Predictors of office SBP reduction at 6 months were baseline office SBP ≥ 180 mmHg, aldosterone antagonist use, and non-use of vasodilators; number of ablations was a predictor in the RDN group. Non-African-American patients receiving RDN had a significantly greater change in office SBP than those receiving sham; -15.2 ± 23.5 vs. -8.6 ± 24.8 mmHg, respectively (P = 0.012). Greater reductions in office and ambulatory SBP, and heart rate were observed with a higher number of ablations and energy delivery in a four-quadrant pattern., Conclusions: Post hoc analyses, although derived from limited patient cohorts, reveal several potential confounding factors that may partially explain the unexpected blood pressure responses in both the sham control and RDN groups. These hypothesis-generating data further inform the design of subsequent research to evaluate the potential role of RDN in the treatment of resistant hypertension. CLINICALTRIALS.GOV IDENTIFIER: NCT01418261., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.)
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- 2015
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28. Efficacy and safety of catheter-based radiofrequency renal denervation in stented renal arteries.
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Mahfoud F, Tunev S, Ruwart J, Schulz-Jander D, Cremers B, Linz D, Zeller T, Bhatt DL, Rocha-Singh K, Böhm M, and Melder RJ
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- Animals, Antihypertensive Agents therapeutic use, Disease Models, Animal, Endovascular Procedures adverse effects, Female, Humans, Hypertension, Renovascular diagnosis, Hypertension, Renovascular etiology, Hypertension, Renovascular physiopathology, Kidney metabolism, Male, Middle Aged, Norepinephrine metabolism, Renal Artery Obstruction complications, Renal Artery Obstruction diagnosis, Renal Artery Obstruction physiopathology, Sus scrofa, Sympathectomy adverse effects, Sympathetic Nervous System metabolism, Sympathetic Nervous System physiopathology, Treatment Failure, Treatment Outcome, Blood Pressure drug effects, Catheter Ablation adverse effects, Endovascular Procedures instrumentation, Hypertension, Renovascular therapy, Kidney blood supply, Renal Artery innervation, Renal Artery Obstruction therapy, Stents, Sympathectomy methods, Sympathetic Nervous System surgery
- Abstract
Background: In selected patients with hypertension, renal artery (RA) stenting is used to treat significant atherosclerotic stenoses. However, blood pressure often remains uncontrolled after the procedure. Although catheter-based renal denervation (RDN) can reduce blood pressure in certain patients with resistant hypertension, there are no data on the feasibility and safety of RDN in stented RA., Methods and Results: We report marked blood pressure reduction after RDN in a patient with resistant hypertension who underwent previous stenting. Subsequently, radiofrequency ablation was investigated within the stented segment of porcine RA, distal to the stented segment, and in nonstented RA and compared with stent only and untreated controls. There were neither observations of thrombus nor gross or histological changes in the kidneys. After radiofrequency ablation of the nonstented RA, sympathetic nerves innervating the kidney were significantly reduced, as indicated by significant decreases in sympathetic terminal axons and reduction of norepinephrine in renal tissue. Similar denervation efficacy was found when RDN was performed distal to a renal stent. In contrast, when radiofrequency ablation was performed within the stented segment of the RA, significant sympathetic nerve ablation was not seen. Histological observation showed favorable healing in all arteries., Conclusions: Radiofrequency ablation of previously stented RA demonstrated that RDN provides equally safe experimental procedural outcomes in a porcine model whether the radiofrequency treatment is delivered within, adjacent, or without the stent struts being present in the RA. However, efficacious RDN is only achieved when radiofrequency ablation is delivered to the nonstented RA segment distal to the stent., (© 2014 American Heart Association, Inc.)
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- 2014
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29. Impact of renal denervation on 24-hour ambulatory blood pressure: results from SYMPLICITY HTN-3.
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Bakris GL, Townsend RR, Liu M, Cohen SA, D'Agostino R, Flack JM, Kandzari DE, Katzen BT, Leon MB, Mauri L, Negoita M, O'Neill WW, Oparil S, Rocha-Singh K, and Bhatt DL
- Subjects
- Double-Blind Method, Female, Humans, Male, Middle Aged, Prospective Studies, Time Factors, Blood Pressure, Blood Pressure Monitoring, Ambulatory, Hypertension surgery, Renal Artery innervation, Renal Artery surgery, Sympathectomy
- Abstract
Background: Prior studies of catheter-based renal artery denervation have not systematically performed ambulatory blood pressure monitoring (ABPM) to assess the efficacy of the procedure., Objectives: SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) was a prospective, blinded, randomized, sham-controlled trial. The current analysis details the effect of renal denervation or a sham procedure on ABPM measurements 6 months post-randomization., Methods: Patients with resistant hypertension were randomized 2:1 to renal denervation or sham control. Patients were on a stable antihypertensive regimen including maximally tolerated doses of at least 3 drugs including a diuretic before randomization. The powered secondary efficacy endpoint was a change in mean 24-h ambulatory systolic blood pressure (SBP). Nondipper to dipper (nighttime blood pressure [BP] 10% to 20% lower than daytime BP) conversion was calculated at 6 months., Results: The 24-h ambulatory SBP changed -6.8 ± 15.1 mm Hg in the denervation group and -4.8 ± 17.3 mm Hg in the sham group: difference of -2.0 mm Hg (95% confidence interval [CI]: -5.0 to 1.1; p = 0.98 with a 2 mm Hg superiority margin). The daytime ambulatory SBP change difference between groups was -1.1 (95% CI: -4.3 to 2.2; p = 0.52). The nocturnal ambulatory SBP change difference between groups was -3.3 (95 CI: -6.7 to 0.1; p = 0.06). The percent of nondippers converted to dippers was 21.2% in the denervation group and 15.0% in the sham group (95% CI: -3.8% to 16.2%; p = 0.30). Change in 24-h heart rate was -1.4 ± 7.4 in the denervation group and -1.3 ± 7.3 in the sham group; (95% CI: -1.5 to 1.4; p = 0.94)., Conclusions: This trial did not demonstrate a benefit of renal artery denervation on reduction in ambulatory BP in either the 24-h or day and night periods compared with sham (Renal Denervation in Patients With Uncontrolled Hypertension [SYMPLICITY HTN-3]; NCT01418261)., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2014
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30. Evaluation of renal nerve morphological changes and norepinephrine levels following treatment with novel bipolar radiofrequency delivery systems in a porcine model.
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Cohen-Mazor M, Mathur P, Stanley JR, Mendelsohn FO, Lee H, Baird R, Zani BG, Markham PM, and Rocha-Singh K
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- Animals, Blood Pressure, Creatinine blood, Heart Rate, Kidney chemistry, Kidney innervation, Models, Animal, Renal Artery pathology, Swine, Tyrosine 3-Monooxygenase analysis, Catheter Ablation methods, Norepinephrine analysis, Renal Artery innervation, Sympathectomy methods
- Abstract
Objective: To evaluate the safety and effectiveness of different bipolar radiofrequency system algorithms in interrupting the renal sympathetic nerves and reducing renal norepinephrine in a healthy porcine model., Methods: A porcine model (N = 46) was used to investigate renal norepinephrine levels and changes to renal artery tissues and nerves following percutaneous renal denervation with radiofrequency bipolar electrodes mounted on a balloon catheter. Parameters of the radiofrequency system (i.e. electrode length and energy delivery algorithm), and the effects of single and longitudinal treatments along the artery were studied with a 7-day model in which swine received unilateral radiofrequency treatments. Additional sets of animals were used to examine norepinephrine and histological changes 28 days following bilateral percutaneous radiofrequency treatment or surgical denervation; untreated swine were used for comparison of renal norepinephrine levels., Results: Seven days postprocedure, norepinephrine concentrations decreased proportionally to electrode length, with 81, 60 and 38% reductions (vs. contralateral control) using 16, 4 and 2-mm electrodes, respectively. Applying a temperature-control algorithm with the 4-mm electrodes increased efficacy, with a mean 89.5% norepinephrine reduction following a 30-s treatment at 68°C. Applying this treatment along the entire artery length affected more nerves vs. a single treatment, resulting in superior norepinephrine reduction 28 days following bilateral treatment., Conclusion: Percutaneous renal artery application of bipolar radiofrequency energy demonstrated safety and resulted in a significant renal norepinephrine content reduction and renal nerve injury compared with untreated controls in porcine models.
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- 2014
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31. A controlled trial of renal denervation for resistant hypertension.
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Bhatt DL, Kandzari DE, O'Neill WW, D'Agostino R, Flack JM, Katzen BT, Leon MB, Liu M, Mauri L, Negoita M, Cohen SA, Oparil S, Rocha-Singh K, Townsend RR, and Bakris GL
- Subjects
- Aged, Blood Pressure, Female, Humans, Intention to Treat Analysis, Male, Middle Aged, Placebos, Radiography, Renal Artery diagnostic imaging, Renal Artery innervation, Single-Blind Method, Treatment Failure, Denervation, Hypertension surgery, Renal Artery surgery
- Abstract
Background: Prior unblinded studies have suggested that catheter-based renal-artery denervation reduces blood pressure in patients with resistant hypertension., Methods: We designed a prospective, single-blind, randomized, sham-controlled trial. Patients with severe resistant hypertension were randomly assigned in a 2:1 ratio to undergo renal denervation or a sham procedure. Before randomization, patients were receiving a stable antihypertensive regimen involving maximally tolerated doses of at least three drugs, including a diuretic. The primary efficacy end point was the change in office systolic blood pressure at 6 months; a secondary efficacy end point was the change in mean 24-hour ambulatory systolic blood pressure. The primary safety end point was a composite of death, end-stage renal disease, embolic events resulting in end-organ damage, renovascular complications, or hypertensive crisis at 1 month or new renal-artery stenosis of more than 70% at 6 months., Results: A total of 535 patients underwent randomization. The mean (±SD) change in systolic blood pressure at 6 months was -14.13±23.93 mm Hg in the denervation group as compared with -11.74±25.94 mm Hg in the sham-procedure group (P<0.001 for both comparisons of the change from baseline), for a difference of -2.39 mm Hg (95% confidence interval [CI], -6.89 to 2.12; P=0.26 for superiority with a margin of 5 mm Hg). The change in 24-hour ambulatory systolic blood pressure was -6.75±15.11 mm Hg in the denervation group and -4.79±17.25 mm Hg in the sham-procedure group, for a difference of -1.96 mm Hg (95% CI, -4.97 to 1.06; P=0.98 for superiority with a margin of 2 mm Hg). There were no significant differences in safety between the two groups., Conclusions: This blinded trial did not show a significant reduction of systolic blood pressure in patients with resistant hypertension 6 months after renal-artery denervation as compared with a sham control. (Funded by Medtronic; SYMPLICITY HTN-3 ClinicalTrials.gov number, NCT01418261.).
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- 2014
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32. Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study.
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Krum H, Schlaich MP, Sobotka PA, Böhm M, Mahfoud F, Rocha-Singh K, Katholi R, and Esler MD
- Subjects
- Antihypertensive Agents therapeutic use, Blood Pressure physiology, Chronic Disease, Diabetic Angiopathies physiopathology, Diabetic Angiopathies surgery, Drug Resistance, Female, Glomerular Filtration Rate physiology, Humans, Hypertension drug therapy, Hypertension physiopathology, Male, Middle Aged, Treatment Outcome, Catheter Ablation methods, Hypertension surgery, Sympathectomy methods
- Abstract
Background: Renal denervation (RDN) with radiofrequency ablation substantially reduces blood pressure in patients with treatment-resistant hypertension. We assessed the long-term antihypertensive effects and safety., Methods: Symplicity HTN-1 is an open-label study that enrolled 153 patients, of whom 111 consented to follow-up for 36 months. Eligible patients had a systolic blood pressure of at least 160 mm Hg and were taking at least three antihypertensive drugs, including a diuretic, at the optimum doses. Changes in office systolic blood pressure and safety were assessed every 6 months and reported every 12 months. This study is registered with ClinicalTrials.gov, numbers NCT00483808, NCT00664638, and NCT00753285., Findings: 88 patients had complete data at 36 months. At baseline the mean age was 57 (SD 11) years, 37 (42%) patients were women, 25 (28%) had type 2 diabetes mellitus, the mean estimated glomerular filtration rate was 85 (SD 19) mL/min per 1·73 m(2), and mean blood pressure was 175/98 (SD 16/14) mm Hg. At 36 months significant changes were seen in systolic (-32·0 mm Hg, 95% CI -35·7 to -28·2) and diastolic blood pressure (-14·4 mm Hg, -16·9 to -11·9). Drops of 10 mm Hg or more in systolic blood pressure were seen in 69% of patients at 1 month, 81% at 6 months, 85% at 12 months, 83% at 24 months, and 93% at 36 months. One new renal artery stenosis requiring stenting and three deaths unrelated to RDN occurred during follow-up., Interpretation: Changes in blood pressure after RDN persist long term in patients with treatment-resistant hypertension, with good safety., Funding: Ardian LLC/Medtronic Inc., (Copyright © 2014 Elsevier Ltd. All rights reserved.)
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- 2014
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33. Excimer laser with adjunctive balloon angioplasty and heparin-coated self-expanding stent grafts for the treatment of femoropopliteal artery in-stent restenosis: twelve-month results from the SALVAGE study.
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Laird JR Jr, Yeo KK, Rocha-Singh K, Das T, Joye J, Dippel E, Reddy B, Botti C, and Jaff MR
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- Aged, Aged, 80 and over, Angioplasty, Balloon adverse effects, Ankle Brachial Index, Arterial Occlusive Diseases complications, Arterial Occlusive Diseases diagnosis, Arterial Occlusive Diseases physiopathology, Atherectomy adverse effects, Combined Modality Therapy, Constriction, Pathologic, Female, Humans, Intermittent Claudication etiology, Intermittent Claudication therapy, Ischemia etiology, Ischemia therapy, Lasers, Excimer adverse effects, Male, Middle Aged, Prospective Studies, Prosthesis Design, Recurrence, Registries, Time Factors, Treatment Outcome, Ultrasonography, Doppler, Duplex, United States, Vascular Patency, Angioplasty, Balloon instrumentation, Anticoagulants administration & dosage, Arterial Occlusive Diseases therapy, Atherectomy methods, Coated Materials, Biocompatible, Drug-Eluting Stents, Femoral Artery diagnostic imaging, Femoral Artery physiopathology, Heparin administration & dosage, Lasers, Excimer therapeutic use, Popliteal Artery diagnostic imaging, Popliteal Artery physiopathology
- Abstract
Objectives: The aim of the study is to evaluate the safety and effectiveness of treating femoropopliteal in-stent restenosis (ISR) with debulking with excimer laser followed by implantation of a VIABAHN endoprosthesis., Background: The optimal treatment strategy for femoropopliteal ISR is unclear., Methods: The SALVAGE study is a multicenter prospective registry involving nine US centers. Patients with femoropopliteal ISR with moderate to severe intermittent claudication or critical limb ischemia (Rutherford categories 2-5) and an ankle-brachial index (ABI) =0.8 were treated with excimer laser and the VIABAHN endoprosthesis. The primary efficacy endpoint is primary patency at 12 months as measured by duplex ultrasonography. The primary safety endpoint is the major adverse event (MAE) rate at 30 days., Results: Twenty-seven patients were enrolled. The mean lesion length was 20.7 ± 10.3 cm. The majority of lesions were TASC (TASC I) C and D (81.4%). All lesions were pretreated with excimer laser and percutaneous transluminal angioplasty (PTA) prior to VIABAHN implantation. Technical success was achieved in 100% of cases. There were no MAE at 30 days. Primary patency at 12 months was 48%. The ankle brachial index increased from 0.58 ± 0.24 at baseline to 0.90 ± 0.17 at 12 months. There was improvement in all quality-of-life parameters. The 12-month TLR rate was 17.4%., Conclusions: The strategy of excimer laser atherectomy and PTA followed by implantation of a self-expanding stent graft for the treatment of femoropopliteal ISR is safe and associated with high procedural success. Primary patency rate at 12-months was suboptimal; however, the TLR rate was low., (Copyright © 2012 Wiley Periodicals, Inc.)
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- 2012
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34. Catheter-based renal denervation for resistant hypertension: rationale and design of the SYMPLICITY HTN-3 Trial.
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Kandzari DE, Bhatt DL, Sobotka PA, O'Neill WW, Esler M, Flack JM, Katzen BT, Leon MB, Massaro JM, Negoita M, Oparil S, Rocha-Singh K, Straley C, Townsend RR, and Bakris G
- Subjects
- Adult, Aged, Blood Pressure, Blood Pressure Monitoring, Ambulatory, Catheters, Humans, Kidney innervation, Middle Aged, Research Design, Single-Blind Method, Treatment Outcome, Young Adult, Hypertension surgery, Kidney surgery, Renal Artery surgery, Sympathectomy methods
- Abstract
Hypertension represents a significant global public health concern, contributing to vascular and renal morbidity, cardiovascular mortality, and economic burden. The opportunity to influence clinical outcomes through hypertension management is therefore paramount. Despite adherence to multiple available medical therapies, a significant proportion of patients have persistent blood pressure elevation, a condition termed resistant hypertension. Recent recognition of the importance of the renal sympathetic and somatic nerves in modulating blood pressure and the development of a novel procedure that selectively removes these contributors to resistant hypertension represents an opportunity to provide clinically meaningful benefit across wide and varied patient populations. Early clinical evaluation with catheter-based, selective renal sympathetic denervation in patients with resistant hypertension has mechanistically correlated sympathetic efferent denervation with decreased renal norepinephrine spillover and renin activity, increased renal plasma flow, and has demonstrated clinically significant, sustained reductions in blood pressure. The SYMPLICITY HTN-3 Trial is a pivotal study designed as a prospective, randomized, masked procedure, single-blind trial evaluating the safety and effectiveness of catheter-based bilateral renal denervation for the treatment of uncontrolled hypertension despite compliance with at least 3 antihypertensive medications of different classes (at least one of which is a diuretic) at maximal tolerable doses. The primary effectiveness endpoint is measured as the change in office-based systolic blood pressure from baseline to 6 months. This manuscript describes the design and methodology of a regulatory trial of selective renal denervation for the treatment of hypertension among patients who have failed pharmacologic therapy., (© 2012 Wiley Periodicals, Inc.)
- Published
- 2012
- Full Text
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35. Feasibility of FiberNet® embolic protection system in patients undergoing angioplasty for atherosclerotic renal artery stenosis.
- Author
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Laird JR, Tehrani F, Soukas P, Joye JD, Ansel GM, and Rocha-Singh K
- Subjects
- Aged, Aged, 80 and over, Angioplasty adverse effects, Atherosclerosis physiopathology, Blood Pressure, Embolism etiology, Feasibility Studies, Female, Humans, Male, Middle Aged, Prospective Studies, Prosthesis Design, Renal Artery Obstruction physiopathology, Severity of Illness Index, Stents, Treatment Outcome, United States, Angioplasty instrumentation, Atherosclerosis therapy, Embolic Protection Devices, Embolism prevention & control, Renal Artery Obstruction therapy
- Abstract
Objective: To evaluate the procedural safety and filter efficiency of Lumen Biomedical FiberNet® embolic protection system in conjunction with primary stenting of ostial atherosclerotic renal artery lesions., Background: There is limited data regarding the utility of distal embolic protection devices in renal artery angioplasty and stenting., Methods: Patients with angiographically severe (≥70%) renal artery stenosis were prospectively enrolled if one or more inclusion criteria met: resistant hypertension, progressive chronic kidney disease, unexplained heart failure, or flash pulmonary edema. Patients underwent renal artery angioplasty and stenting with utilization of the Lumen Biomedical FiberNet® EPS. The protection devices and aspirate were analyzed for degree of atheromatous particles. Procedural safety and clinical outcomes were assessed through 6 months., Results: Twenty patients were prospectively enrolled at five centers; average age 73.8 (±9.5) years, mean baseline eGFR 60.8 cm(3) min(-1). Twenty-five renal artery stenting procedures were performed. Device and procedural success were achieved in 100% of cases. All patients tolerated the procedure without any adverse events. Embolic debris was captured in all cases. Debris analysis of the distal protection system displayed an average post procedure atheroma area of 51.31 mm(2). There was no clinical evidence of peripheral atheroembolization through 30-days follow-up. No subjects progressed to temporary or permanent renal replacement therapy. Favorable trends in blood pressure control were observed at 6 months., Conclusion: The Lumen Biomedical FiberNet® embolic protection system is a safe and feasible method to prevent atheroembolization associated with angioplasty and stenting of renal artery ostial lesions., (Copyright © 2011 Wiley Periodicals, Inc.)
- Published
- 2012
- Full Text
- View/download PDF
36. Stroke intervention: catheter-based therapy for acute ischemic stroke.
- Author
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White CJ, Abou-Chebl A, Cates CU, Levy EI, McMullan PW, Rocha-Singh K, Weinberger JM, and Wholey MH
- Subjects
- Angioplasty methods, Cardiology methods, Diagnostic Imaging methods, Guidelines as Topic, Humans, Reperfusion methods, Stents, Thrombectomy methods, Thrombolytic Therapy methods, Treatment Outcome, United States, Catheters, Ischemia therapy, Stroke therapy
- Abstract
The majority (>80%) of the three-quarters of a million strokes that will occur in the United States this year are ischemic in nature. The treatment of acute ischemic stroke is very similar to acute myocardial infarction, which requires timely reperfusion therapy for optimal results. The majority of patients with acute ischemic stroke do not receive any form of reperfusion therapy, unlike patients with acute myocardial infarction. Improving outcomes for acute stroke will require patient education to encourage early presentation, an aggressive expansion of qualified hospitals, and willing providers and early imaging strategies to match patients with their best options for reperfusion therapy to minimize complications., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2011
- Full Text
- View/download PDF
37. Heparin-induced thrombocytopenia with thrombosis after endovascular aneurysm repair.
- Author
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Kolluri R, Rocha-Singh K, Sarac T, and Bartholomew JR
- Subjects
- Aged, Angiography, Arterial Occlusive Diseases pathology, Arterial Occlusive Diseases therapy, Humans, Male, Middle Aged, Thrombocytopenia pathology, Thrombocytopenia therapy, Thrombosis pathology, Thrombosis therapy, Ultrasonography, Doppler, Duplex, Venous Thrombosis pathology, Venous Thrombosis therapy, Anticoagulants adverse effects, Aortic Aneurysm, Abdominal surgery, Arterial Occlusive Diseases chemically induced, Blood Vessel Prosthesis Implantation, Heparin adverse effects, Thrombocytopenia chemically induced, Thrombosis chemically induced, Venous Thrombosis chemically induced
- Abstract
Heparin-induced thrombocytopenia is an immune-mediated syndrome that results from unfractionated heparin or low molecular weight heparin exposure. It often remains unrecognized and undertreated and can cause limb and/or life-threatening thrombosis. The authors present 2 cases of thrombosis: one arterial and the other venous that occurred following endovascular abdominal aortic aneurysm repair. To the authors' knowledge, this is only the second report of arterial thrombosis and the first of deep vein thrombosis as a result of heparin-induced thrombocytopenia developing following endovascular abdominal aortic aneurysm repair. This underscores the importance of considering heparin-induced thrombocytopenia as a potential cause for postendovascular thrombotic complications in the patient who develops thrombocytopenia following this procedure.
- Published
- 2009
- Full Text
- View/download PDF
38. Renal artery stenting with noninvasive duplex ultrasound follow-up: 3-year results from the RENAISSANCE renal stent trial.
- Author
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Rocha-Singh K, Jaff MR, and Lynne Kelley E
- Subjects
- Adult, Aged, Aged, 80 and over, Angiography, Digital Subtraction, Angioplasty, Balloon adverse effects, Female, Humans, Male, Middle Aged, Predictive Value of Tests, Prospective Studies, Prosthesis Design, Recurrence, Renal Circulation, Time Factors, Treatment Outcome, United States, Vascular Patency, Vascular Resistance, Angioplasty, Balloon instrumentation, Atherosclerosis diagnostic imaging, Atherosclerosis surgery, Renal Artery Obstruction diagnostic imaging, Renal Artery Obstruction surgery, Stents, Ultrasonography, Doppler, Color
- Abstract
Objective: The multicenter, single-arm RENAISSANCE trial evaluated outcomes in patients with progressive atherosclerotic renal artery stenosis (ARAS) treated with the Express Renal Premounted Stent System (Boston Scientific, Natick, MA)., Background: Renal artery stenting may prevent the morbidity and mortality of surgical revascularization and high restenosis rates of percutaneous renal angioplasty (PTRA). Renal artery duplex ultrasonography (DUS) offers an alternative to traditional invasive poststenting angiographic surveillance, though concordance with angiography for in-stent restenosis has yet to be validated independently., Methods: RENAISSANCE enrolled 100 patients (117 lesions) with de novo or restenotic ostial atherosclerotic lesions
or=4.0 and or=70%. The primary endpoint, 9-month binary restenosis, was compared to an objective performance criterion (OPC) of 40% for published PTRA results. Follow-up was conducted through 3 years., Results: Technical and procedural success was both 99%. Follow-up angiography, triggered clinically or by ultrasonography, revealed 21.3% binary restenosis at 9 months, which was superior to the OPC (P < 0.0001). Concordance between ultrasonography and angiography for detection of binary restenosis at 9 months was 87%. Peak systolic velocity and renal-to-aortic ratio were both significantly improved compared to baseline at 9 months and 2 years. The major adverse event (defined as device- or procedure-related death, target lesion revascularization or significant embolic event) rate was 10.5% at 9 months and 20.9% at 3 years., Conclusions: RENAISSANCE demonstrates that renal artery stenting is superior to the prespecified OPC at 9 months, and also shows that DUS can accurately identify in-stent restenosis., ((c) 2008 Wiley-Liss, Inc.) - Published
- 2008
- Full Text
- View/download PDF
39. Results from a phase II multicenter, double-blind placebo-controlled study of Del-1 (VLTS-589) for intermittent claudication in subjects with peripheral arterial disease.
- Author
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Grossman PM, Mendelsohn F, Henry TD, Hermiller JB, Litt M, Saucedo JF, Weiss RJ, Kandzari DE, Kleiman N, Anderson RD, Gottlieb D, Karlsberg R, Snell J, and Rocha-Singh K
- Subjects
- Adult, Aged, Aged, 80 and over, Ankle blood supply, Blood Pressure, Brachial Artery physiopathology, Calcium-Binding Proteins, Cell Adhesion Molecules, Double-Blind Method, Exercise Tolerance, Female, Genetic Therapy, Humans, Injections, Intramuscular, Intermittent Claudication physiopathology, Male, Middle Aged, Quality of Life, Treatment Outcome, Walking, Carrier Proteins therapeutic use, Genetic Vectors therapeutic use, Intermittent Claudication etiology, Intermittent Claudication therapy, Peripheral Vascular Diseases complications, Plasmids therapeutic use
- Abstract
Background: This study compared VLTS-589 (plasmid encoding the angiomatrix protein Del-1 in conjunction with poloxamer 188) with poloxamer 188 control, for the treatment of intermittent claudication in patients with moderate to severe peripheral arterial disease., Methods: Subjects with bilateral intermittent claudication and peak walking time (PWT) between 1 and 10 minutes on 2 qualifying (reproducible; within 25% of each other) treadmill tests were enrolled. Patients received VLTS-589 or poloxamer 188 control, administered as 21 intramuscular injections to each lower extremity (42 mL in each extremity). In addition to safety and tolerability, efficacy evaluations compared to baseline included the following: change in PWT at 90 days (primary end point), change in claudication onset time, change in ankle brachial index (ABI), and change in quality of life measures., Results: A total of 105 patients were randomized and treated. During the 30, 90, and 180 days follow-up, mean PWT, claudication onset time, and ABI were significantly increased compared to baseline values in both treatment groups with no significant difference between groups in the primary or secondary end points. In addition, both groups demonstrated significantly improved quality of life at follow-up vs baseline, with no significant differences between groups. Serious adverse events were similar in both groups--none were definitely treatment-related., Conclusion: Intramuscular delivery of both Del-1 expressing plasmid and the control resulted in significant improvement in exercise capacity compared to baseline at 30, 90, and 180 days. There was no difference in outcome measures associated with the Del-1 plasmid.
- Published
- 2007
- Full Text
- View/download PDF
40. Percutaneous renal artery intervention for preservation of renal function: strategies for identification of "at-risk" patients.
- Author
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Rocha-Singh K
- Subjects
- Atherosclerosis complications, Glomerular Filtration Rate physiology, Humans, Kidney blood supply, Renal Artery Obstruction etiology, Renal Artery Obstruction physiopathology, Risk Factors, Kidney physiopathology, Renal Artery Obstruction therapy, Vascular Surgical Procedures methods
- Published
- 2006
- Full Text
- View/download PDF
41. Percutaneous vascular interventions in renal artery diseases.
- Author
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Kolluri R, Goldstein JA, and Rocha-Singh K
- Subjects
- Humans, Renal Artery Obstruction diagnosis, Renal Artery Obstruction etiology, Stents, Treatment Outcome, Angioplasty, Balloon instrumentation, Angioplasty, Balloon methods, Atherosclerosis complications, Renal Artery Obstruction therapy
- Abstract
Renal artery stenosis (RAS) is a progressive manifestation of atherosclerosis. It is associated with hypertension and progressive renal failure. Noninvasive testing includes renal artery duplex, computed tomographic angiography (CTA) and magnetic resonance angiography (MRA). Percutaneous transluminal renal angioplasty and stenting (PTRAS) is indicated for significant atherosclerotic RAS while percutaneous transluminal renal angioplasty (PTRA) is indicated for fibromuscular dysplasias (FMD) associated with the proper clinical indications. PTRAS is associated with a high technical success rate and an acceptable adverse event and restenosis rate. PTRAS appears to improve control of hypertension and renal preservation. All patients should be followed clinically and with periodic duplex ultrasonography. Restenosis is treated with repeat angioplasty and occasionally stenting. Current and future areas of investigation will involve distal protection and drug eluting stents.
- Published
- 2006
42. Functional and clinical outcomes of nitinol stenting with and without abciximab for complex superficial femoral artery disease: a randomized trial.
- Author
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Ansel GM, Silver MJ, Botti CF Jr, Rocha-Singh K, Bates MC, Rosenfield K, Schainfeld RM, Laster SB, and Zander C
- Subjects
- Abciximab, Aged, Aged, 80 and over, Alloys, Angiography, Angioplasty, Balloon, Chi-Square Distribution, Female, Humans, Male, Middle Aged, Treatment Outcome, Ultrasonography, Doppler, Duplex, Antibodies, Monoclonal administration & dosage, Arterial Occlusive Diseases therapy, Femoral Artery, Immunoglobulin Fab Fragments administration & dosage, Peripheral Vascular Diseases therapy, Platelet Glycoprotein GPIIb-IIIa Complex antagonists & inhibitors, Stents
- Abstract
Objective: To evaluate the effect of glycoprotein IIb/IIIa inhibition during nitinol stenting, of superficial femoral occlusive disease., Background: Stent implantation in the superficial femoral artery has been associated with suboptimal results while Glycoprotein IIb/IIIa inhibitors have shown improved procedural results during coronary intervention. We evaluated abciximab infusion during (Smart Stent) implantation in superficial femoral obstructions., Methods: We conducted a randomized placebo controlled trial. The two primary end points include: (1) 9-month restenosis defined as a decrease in ankle brachial index and in-stent duplex ultrasound restenosis: (2) adverse events defined as death (30 days) or repeat revascularization within 9 months., Results: Twenty-seven patients were randomized to abciximab and 24 patients to control (placebo). The primary end point of cumulative restenosis occurred in 15.4% of patients administered abciximab and in 12% administered placebo (P = 0.873). The primary restenosis endpoint in diabetics and total occlusions were similar at 14.3% and 15.4% respectively. The composite end point of 30-day mortality and 9-month revascularization occurred in 5.8% abciximab and 0% (P = 0.274) placebo with no 30-day deaths. Graded treadmill time and Rutherford class were all significantly improved in both groups, but the abciximab group did not appear to demonstrate any identifiable effect., Conclusion: (Smart Stent) nitinol stenting of the superficial femoral artery was associated with favorable functional outcomes at 9 months. Adjunctive abciximab did not appear to demonstrate any identifiable effect., (2006 Wiley-Liss, Inc.)
- Published
- 2006
- Full Text
- View/download PDF
43. Evaluation of the safety and effectiveness of renal artery stenting after unsuccessful balloon angioplasty: the ASPIRE-2 study.
- Author
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Rocha-Singh K, Jaff MR, and Rosenfield K
- Subjects
- Adult, Aged, Aged, 80 and over, Atherosclerosis therapy, Female, Humans, Male, Middle Aged, Prospective Studies, Renal Artery Obstruction therapy, Reoperation, Time Factors, Angioplasty, Balloon, Atherosclerosis surgery, Blood Vessel Prosthesis Implantation, Renal Artery Obstruction surgery, Stents, Treatment Failure
- Abstract
Objectives: This study sought to define the safety and durability of renal stenting after suboptimal/failed renal artery angioplasty in patients with suspected renovascular hypertension., Background: Few prospective multicenter studies have detailed the safety, efficacy, and long-term clinical benefits of renal artery stent revascularization in hypertensive patients with aorto-ostial atherosclerotic renal artery lesions., Methods: This non-randomized study enrolled 208 patients with de novo or restenotic > or = 70% aorto-ostial renal artery stenoses, who underwent implantation of a balloon-expandable stent after unsuccessful percutaneous transluminal renal angioplasty (PTRA), which was defined as a > or = 50% residual stenosis, persistent translesional pressure gradient, or a flow-limiting dissection. The primary end point was the nine-month quantitative angiographic or duplex ultrasonography restenosis rate adjudicated by core laboratory analysis. Secondary end points included renal function, blood pressure, and cumulative incidence of major adverse events and target lesion revascularization at 24 months., Results: The stent procedure was immediately successful in 182 of 227 (80.2%) lesions treated. The nine-month restenosis rate was 17.4%. Systolic/diastolic blood pressure decreased from 168 +/- 25/82 +/- 13 mm Hg (mean +/- standard deviation) at baseline to 149 +/- 24/77 +/- 12 mm Hg at 9 months (p < 0.001 vs. baseline), and 149 +/- 25/77 +/- 12 mm Hg at 24 months (p < 0.001 vs. baseline). Mean serum creatinine concentration was unchanged from baseline values at 9 and 24 months. The 24-month cumulative rate of major adverse events was 19.7%., Conclusions: In hypertensive patients with aorto-ostial atherosclerotic renal artery stenosis in whom PTRA is unsuccessful, Palmaz (Cordis Corp., Warren, New Jersey) balloon-expandable stents provide a safe and durable revascularization strategy, with a beneficial impact on hypertension.
- Published
- 2005
- Full Text
- View/download PDF
44. Femoropopliteal subintimal angioplasty and nitinol stenting: a marriage of technique and technology...but will it last?
- Author
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Rocha-Singh K
- Subjects
- Angioplasty, Balloon, Arterial Occlusive Diseases diagnostic imaging, Blood Vessel Prosthesis Implantation methods, Coated Materials, Biocompatible therapeutic use, Coronary Stenosis diagnostic imaging, Coronary Stenosis therapy, Femoral Artery diagnostic imaging, Humans, Intermittent Claudication diagnostic imaging, Intermittent Claudication therapy, Popliteal Artery diagnostic imaging, Popliteal Artery pathology, Popliteal Artery surgery, Radiography, Tunica Intima diagnostic imaging, Alloys therapeutic use, Arterial Occlusive Diseases therapy, Femoral Artery pathology, Femoral Artery surgery, Stents, Tunica Intima pathology, Tunica Intima surgery
- Published
- 2005
- Full Text
- View/download PDF
45. Renal and iliac artery stenting by interventional cardiologists and vascular surgeons: the Foundation to Advance Medical Education (FAME) initiative.
- Author
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Holmes DR Jr, Fox RD, Tommaso C, Hodgson PK, Green R, Rocha-Singh K, and Rosenfield K
- Subjects
- Animals, Computer Simulation, Humans, Pilot Projects, Program Evaluation, Cardiology education, Education, Medical, Continuing, Iliac Artery, Renal Artery, Stents, Vascular Surgical Procedures education
- Abstract
The American College of Cardiology, in concert with the Society for Coronary Angiography and Interventions and the Society for Vascular Surgery, planned and implemented an initiative to teach stenting of renal and iliac arteries to their peers in practice. Supported by the Foundation to advance medical Education (FAME), the initiative involved 25 preceptees and 6 preceptors and included a didactic portion (a remote learning exercise), an animal practicum, a procedural simulation, and a preceptor/preceptee training segment, all of which was followed by evaluations by the participants. Assessments of the success of the initiative differed between preceptees, who were positive about the experience, and preceptors, who were more critical of the endeavor (with surgeons more critical than cardiologists). Technical problems, such as obtaining temporary licensure to practice medicine in another state, interfered with the hands-on experiences of several preceptees. Programs such as the FAME initiative will grow in importance as new technologies continue to be introduced into medical practice and the need to train physicians in practice in their use expands.
- Published
- 2005
- Full Text
- View/download PDF
46. The peripheral artery questionnaire: a new disease-specific health status measure for patients with peripheral arterial disease.
- Author
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Spertus J, Jones P, Poler S, and Rocha-Singh K
- Subjects
- Aged, Diabetes Complications, Female, Humans, Hypertension complications, Male, Middle Aged, Outcome Assessment, Health Care methods, Patient Satisfaction, Prospective Studies, Quality of Life, Reproducibility of Results, Health Status, Peripheral Vascular Diseases complications, Peripheral Vascular Diseases psychology, Surveys and Questionnaires
- Abstract
Background: The most common indication for treating patients with peripheral arterial disease is to improve their health status: their symptoms, function, and quality of life. Quantifying health status requires a valid, reproducible, and sensitive disease-specific measure. The Peripheral Artery Questionnaire (PAQ) is a 20-item questionnaire developed to meet this need by quantifying patients' physical limitations, symptoms, social function, treatment satisfaction, and quality of life., Methods: Psychometric and clinical properties of the PAQ were evaluated in a prospective cohort study of 44 patients undergoing elective percutaneous peripheral revascularization. To establish reproducibility, 2 assessments were performed 2 weeks apart and before revascularization. The change in scores before and 6 weeks after revascularization were used to determine the instruments' responsiveness and were compared with the Short Form-36 and the Walking Impairment Questionnaire. A series of cross-sectional analyses were performed to establish the construct validity of the PAQ., Results: The 7 domains of the PAQ were internally reliable, with Cronbach alpha = 0.80 to 0.94. The test-retest reliability analyses revealed insignificant mean changes of 0.6 to 2.3 points (P = not significant for all). Conversely, the change after revascularization ranged from 13.7 to 41.9 points (P < or =.001 for all), reflecting substantial sensitivity of the PAQ to clinical improvement. The PAQ Summary Scale was the most sensitive of all scales tested. Construct validity was established by demonstrating correlations with other measures of patient health status., Conclusions: The PAQ is a valid, reliable, and responsive disease-specific measure for patients with peripheral arterial disease. It may prove to be a useful end point in clinical trials and a potential aid in disease management.
- Published
- 2004
- Full Text
- View/download PDF
47. Aortorenal artery translesion pressure gradients in renovascular hypertension: In search of clinical significance.
- Author
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Rocha-Singh K
- Subjects
- Blood Pressure Determination, Catheterization methods, Equipment Design, Equipment Safety, Hemodynamics physiology, Humans, Pressure, Risk Assessment, Sensitivity and Specificity, Catheterization instrumentation, Hypertension, Renovascular diagnosis, Renal Artery Obstruction diagnosis
- Published
- 2003
- Full Text
- View/download PDF
48. Hope springs eternal: the unfulfilled promise of femoropopliteal stenting.
- Author
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Rocha-Singh K
- Subjects
- Humans, Arterial Occlusive Diseases therapy, Arteriosclerosis therapy, Femoral Artery, Popliteal Artery, Stents
- Published
- 2002
- Full Text
- View/download PDF
49. Therapeutic angiogenesis with recombinant fibroblast growth factor-2 for intermittent claudication (the TRAFFIC study): a randomised trial.
- Author
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Lederman RJ, Mendelsohn FO, Anderson RD, Saucedo JF, Tenaglia AN, Hermiller JB, Hillegass WB, Rocha-Singh K, Moon TE, Whitehouse MJ, and Annex BH
- Subjects
- Aged, Analysis of Variance, Double-Blind Method, Drug Administration Schedule, Female, Fibroblast Growth Factor 2 administration & dosage, Fibroblast Growth Factor 2 adverse effects, Humans, Infusions, Intra-Arterial, Leg blood supply, Male, Treatment Outcome, Walking, Fibroblast Growth Factor 2 therapeutic use, Intermittent Claudication drug therapy, Neovascularization, Physiologic drug effects
- Abstract
Background: Recombinant fibroblast growth factor-2 (rFGF-2) improves perfusion in models of myocardial and hindlimb ischaemia. We investigated whether one or two doses of intra-arterial rFGF-2 improves exercise capacity in patients with moderate-to-severe intermittent claudication., Methods: 190 patients with intermittent claudication caused by infra-inguinal atherosclerosis were randomly assigned (1:1:1) bilateral intra-arterial infusions of placebo on days 1 and 30 (n=63); rFGF-2 (30 microg/kg) on day 1 and placebo on day 30 (single-dose, n=66); or rFGF-2 (30 microg/kg) on days 1 and 30 (double-dose, n=61). Primary outcome was 90-day change in peak walking time. Secondary outcomes included ankle-brachial pressure index and safety. The main analysis was per protocol., Findings: Before 90 days, six patients had undergone peripheral revascularisation and were excluded, and ten withdrew or had missing data. 174 were therefore assessed for primary outcome. Peak walking time at 90 days was increased by 0.60 min with placebo, by 1.77 min with single-dose, and by 1.54 min with double-dose. By ANOVA, the difference between groups was p=0.075. In a secondary intention-to-treat analysis, in which all 190 patients were included, the difference was p=0.034. Pairwise comparison showed a significant difference between placebo and single-dose (p=0.026) but placebo and double-dose did not differ by much (p=0.45). Serious adverse events were similar in all groups., Interpretation: Intra-arterial rFGF-2 resulted in a significant increase in peak walking time at 90 days; repeat infusion at 30 days was no better than one infusion. The findings of TRAFFIC provide evidence of clinical therapeutic angiogenesis by intra-arterial infusion of an angiogenic protein.
- Published
- 2002
- Full Text
- View/download PDF
50. The Barath cutting balloon: battling the sword of Damocles.
- Author
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Rocha-Singh K
- Subjects
- Angioplasty, Balloon instrumentation, Humans, Angioplasty, Balloon methods, Coronary Stenosis therapy
- Published
- 2002
- Full Text
- View/download PDF
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