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Paul A Sobotka - One of the best experts on this subject based on the ideXlab platform.

  • antihypertensive effects of a central Arteriovenous Anastomosis are mediated through profound reduction in systemic vascular resistance
    Circulation-cardiovascular Interventions, 2016
    Co-Authors: Manish Saxena, Paul A Sobotka, Stephen Hamshere, Ajay N Jain, Anthony Mathur, Charles Knight, David Collier, Melvin D Lobo
    Abstract:

    Device-based therapies increase therapeutic options for the treatment of hypertension for patients who fail polypharmacy because of adverse reactions or choice. Here we report the physiology related to a device, which uniquely addresses the structural pathogenesis of hypertension. Creation of a fixed-size central Arteriovenous Anastomosis mechanically causes an immediate and significant reduction of blood pressure (BP).1 We present the first detailed hemodynamic findings before and after implantation of the ROX Coupler. A 74-year-old white female with longstanding isolated systolic hypertension complicated by multiple drug intolerances was referred for treatment of her hypertension. She could only tolerate liquid furosemide 20 mg daily, which lowered her office BP from 220/100 mm Hg to 190/90 mm Hg. She exhibited features of raised arterial stiffness with increased pulse pressure and pulse wave velocity, and it was felt that sympathomodulation would not be beneficial for BP control. An Arteriovenous Anastomosis was created using the ROX coupler, inserted in a standard catheterization laboratory setting under fluoroscopic guidance via an endovascular approach through the femoral vessels (Figure 1).2 In situ, the …

  • Effect of Arteriovenous Anastomosis on Blood Pressure Reduction in Patients With Isolated Systolic Hypertension Compared With Combined Hypertension.
    2016
    Co-Authors: Christian Ott, Neil Sulke, Paul A Sobotka, Melvin D Lobo, E Dolan, Felix Mahfoud, Alice V Stanton, John Cockcroft, Markus Van Der Giet, J Hoyer
    Abstract:

    BACKGROUND: Options for interventional therapy to lower blood pressure (BP) in patients with treatment-resistant hypertension include renal denervation and the creation of an Arteriovenous Anastomosis using the ROX coupler. It has been shown that BP response after renal denervation is greater in patients with combined hypertension (CH) than in patients with isolated systolic hypertension (ISH). We analyzed the effect of ROX coupler implantation in patients with CH as compared with ISH. METHODS AND RESULTS: The randomized, controlled, prospective ROX Control Hypertension Study included patients with true treatment-resistant hypertension (office systolic BP ≥140 mm Hg, average daytime ambulatory BP ≥135/85 mm Hg, and treatment with ≥3 antihypertensive drugs including a diuretic). In a post hoc analysis, we stratified patients with CH (n=31) and ISH (n=11). Baseline office systolic BP (177±18 mm Hg versus 169±17 mm Hg, P=0.163) and 24-hour ambulatory systolic BP (159±16 mm Hg versus 154±11 mm Hg, P=0.463) did not differ between patients with CH and those with ISH. ROX coupler implementation resulted in a significant reduction in office systolic BP (CH: -29±21 mm Hg versus ISH: -22±31 mm Hg, P=0.445) and 24-hour ambulatory systolic BP (CH: -14±20 mm Hg versus ISH: -13±15 mm Hg, P=0.672), without significant differences between the two groups. The responder rate (office systolic BP reduction ≥10 mm Hg) after 6 months was not different (CH: 81% versus ISH: 82%, P=0.932). CONCLUSIONS: Our data suggest that creation of an Arteriovenous Anastomosis using the ROX coupler system leads to a similar reduction of office and 24-hour ambulatory systolic BP in patients with combined and isolated systolic hypertension. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01642498

  • central Arteriovenous Anastomosis for the treatment of patients with uncontrolled hypertension the rox control htn study a randomised controlled trial
    The Lancet, 2015
    Co-Authors: Melvin D Lobo, Steve Furniss, Neil Sulke, Paul A Sobotka, A Stanton, E Dolan, J Hoyer, John R Cockcroft, Markus Van Der Giet, John P Foran
    Abstract:

    Summary Background Hypertension contributes to cardiovascular morbidity and mortality. We assessed the safety and efficacy of a central iliac Arteriovenous Anastomosis to alter the mechanical arterial properties and reduce blood pressure in patients with uncontrolled hypertension. Methods We enrolled patients in this open-label, multicentre, prospective, randomised, controlled trial between October, 2012, and April, 2014. Eligible patients had baseline office systolic blood pressure of 140 mm Hg or higher and average daytime ambulatory blood pressure of 135 mm Hg or higher systolic and 85 mm Hg or higher diastolic despite antihypertensive treatment. Patients were randomly allocated in a 1:1 ratio to undergo implantation of an Arteriovenous coupler device plus current pharmaceutical treatment or to maintain current treatment alone (control). The primary endpoint was mean change from baseline in office and 24 h ambulatory systolic blood pressure at 6 months. Analysis was by modified intention to treat (all patients remaining in follow-up at 6 months). This trial is registered with ClinicalTrials.gov, number NCT01642498. Findings 83 (43%) of 195 patients screened were assigned Arteriovenous coupler therapy (n=44) or normal care (n=39). Mean office systolic blood pressure reduced by 26·9 (SD 23·9) mm Hg in the Arteriovenous coupler group (p Interpretation Arteriovenous Anastomosis was associated with significantly reduced blood pressure and hypertensive complications. This approach might be a useful adjunctive therapy for patients with uncontrolled hypertension. Funding ROX Medical.

  • the rox coupler creation of a fixed iliac Arteriovenous Anastomosis for the treatment of uncontrolled systemic arterial hypertension exploiting the physical properties of the arterial vasculature
    Catheterization and Cardiovascular Interventions, 2015
    Co-Authors: John P Foran, Ajay K Jain, Ivan P Casserly, David E Kandzari, Krishna J Rochasingh, Adam Witkowski, Barry T Katzen, David Deaton, Peter Balmforth, Paul A Sobotka
    Abstract:

    Objectives: Uncontrolled hypertension, whether due to drug resistance or poor adherence and persistence, remains a problem in many patients. The ROX coupler is a novel technology designed to reduce arterial blood pressure consequent to the predicted physical effects of reducing vascular resistance and improving arterial compliance. This article describes the technical aspects of the device and implantation procedure, results from a preclinical study, patient selection criteria, and potential complications of this therapy for uncontrolled hypertension. Background: The coupler is a self-expanding, stent-like device that exploits the mechanical effects of the creation of a low-resistance, high-compliance venous segment to the central arterial tree, and can be implanted in a standard catheterization laboratory under fluoroscopic guidance. Methods: Preclinical studies were conducted in sheep with acute or chronic hypertension. The devices were implanted in the aorta for up to 12 months. The anastomoses were evaluated for patency, healing, conformation into the artery and vein, and complications. Results: Deployment of the anastomotic device in ovine aortas for up to 12 months showed optimal anastomotic patency in all animals with proper healing and conformation of the device into the artery and the vein. There was no significant residual mural thrombus and minimal to moderate intimal thickening at the vein outflow, consistent with expected arterialization. Conclusions: A novel Arteriovenous coupler for percutaneous placement in the iliac vasculature is under clinical investigation as a potential treatment modality for selected patients with uncontrolled hypertension. Initial results from patients with uncontrolled hypertension are expected in Autumn 2014. © 2014 Wiley Periodicals, Inc.

Neil Sulke - One of the best experts on this subject based on the ideXlab platform.

  • central Arteriovenous Anastomosis for the treatment of patients with uncontrolled hypertension and paroxysmal af
    American Heart Journal, 2019
    Co-Authors: William Eysenck, Jet Van Zalen, Nick Freemantle, Guy Lloyd, Steve Furniss, Neil Sulke
    Abstract:

    A central iliac Arteriovenous Anastomosis, the 'coupler' (ROX Medical, California, USA) results in a significant reduction in blood pressure in hypertensive patients. This study assessed the change in AF burden following coupler implantation in patients with paroxysmal AF (PAF) and hypertension. Good blood pressure control using the coupler results in a significant reduction in AF burden.

  • Effect of Arteriovenous Anastomosis on Blood Pressure Reduction in Patients With Isolated Systolic Hypertension Compared With Combined Hypertension.
    2016
    Co-Authors: Christian Ott, Neil Sulke, Paul A Sobotka, Melvin D Lobo, E Dolan, Felix Mahfoud, Alice V Stanton, John Cockcroft, Markus Van Der Giet, J Hoyer
    Abstract:

    BACKGROUND: Options for interventional therapy to lower blood pressure (BP) in patients with treatment-resistant hypertension include renal denervation and the creation of an Arteriovenous Anastomosis using the ROX coupler. It has been shown that BP response after renal denervation is greater in patients with combined hypertension (CH) than in patients with isolated systolic hypertension (ISH). We analyzed the effect of ROX coupler implantation in patients with CH as compared with ISH. METHODS AND RESULTS: The randomized, controlled, prospective ROX Control Hypertension Study included patients with true treatment-resistant hypertension (office systolic BP ≥140 mm Hg, average daytime ambulatory BP ≥135/85 mm Hg, and treatment with ≥3 antihypertensive drugs including a diuretic). In a post hoc analysis, we stratified patients with CH (n=31) and ISH (n=11). Baseline office systolic BP (177±18 mm Hg versus 169±17 mm Hg, P=0.163) and 24-hour ambulatory systolic BP (159±16 mm Hg versus 154±11 mm Hg, P=0.463) did not differ between patients with CH and those with ISH. ROX coupler implementation resulted in a significant reduction in office systolic BP (CH: -29±21 mm Hg versus ISH: -22±31 mm Hg, P=0.445) and 24-hour ambulatory systolic BP (CH: -14±20 mm Hg versus ISH: -13±15 mm Hg, P=0.672), without significant differences between the two groups. The responder rate (office systolic BP reduction ≥10 mm Hg) after 6 months was not different (CH: 81% versus ISH: 82%, P=0.932). CONCLUSIONS: Our data suggest that creation of an Arteriovenous Anastomosis using the ROX coupler system leads to a similar reduction of office and 24-hour ambulatory systolic BP in patients with combined and isolated systolic hypertension. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01642498

  • central Arteriovenous Anastomosis for the treatment of patients with uncontrolled hypertension the rox control htn study a randomised controlled trial
    The Lancet, 2015
    Co-Authors: Melvin D Lobo, Steve Furniss, Neil Sulke, Paul A Sobotka, A Stanton, E Dolan, J Hoyer, John R Cockcroft, Markus Van Der Giet, John P Foran
    Abstract:

    Summary Background Hypertension contributes to cardiovascular morbidity and mortality. We assessed the safety and efficacy of a central iliac Arteriovenous Anastomosis to alter the mechanical arterial properties and reduce blood pressure in patients with uncontrolled hypertension. Methods We enrolled patients in this open-label, multicentre, prospective, randomised, controlled trial between October, 2012, and April, 2014. Eligible patients had baseline office systolic blood pressure of 140 mm Hg or higher and average daytime ambulatory blood pressure of 135 mm Hg or higher systolic and 85 mm Hg or higher diastolic despite antihypertensive treatment. Patients were randomly allocated in a 1:1 ratio to undergo implantation of an Arteriovenous coupler device plus current pharmaceutical treatment or to maintain current treatment alone (control). The primary endpoint was mean change from baseline in office and 24 h ambulatory systolic blood pressure at 6 months. Analysis was by modified intention to treat (all patients remaining in follow-up at 6 months). This trial is registered with ClinicalTrials.gov, number NCT01642498. Findings 83 (43%) of 195 patients screened were assigned Arteriovenous coupler therapy (n=44) or normal care (n=39). Mean office systolic blood pressure reduced by 26·9 (SD 23·9) mm Hg in the Arteriovenous coupler group (p Interpretation Arteriovenous Anastomosis was associated with significantly reduced blood pressure and hypertensive complications. This approach might be a useful adjunctive therapy for patients with uncontrolled hypertension. Funding ROX Medical.

B. Jeroen Klevering - One of the best experts on this subject based on the ideXlab platform.

  • Peripheral retinal nonperfusion associated with chronic myeloid leukemia.
    American journal of ophthalmology, 2003
    Co-Authors: Siamak Nobacht, Kathleen F.k Vandoninck, August F. Deutman, B. Jeroen Klevering
    Abstract:

    Abstract Purpose To report a case of peripheral retinal nonperfusion and chronic myeloid leukemia in a 23-year-old woman. Design Observational case report. Methods A complete ophthalmic and systemic evaluation was performed. Results Ophthalmic examination revealed peripheral retinal nonperfusion with retinal neovascularization in both eyes. Fluorescein angiography of both eyes showed a marked midperipheral and peripheral avascular retina temporally with Arteriovenous Anastomosis and seafan neovascularizations. Blood work showed no abnormalities, although marked leucocytosis (up to 750 × 10 9 /l) and thrombocytosis (646 × 10 9 /l) were present in 1998 when the patient was diagnosed with leukemia. Following treatment, the patient has been in remission. Conclusions Peripheral retinal nonperfusion with retinal neovascularization may occur as a complication of chronic myeloid leukemia. In contrast to other studies describing this association, our patient had a bilateral peripheral retinal nonperfusion with seafan neovascularizations without relapse of the myeloid leukemia and without any of the other retinal signs associated with chronic myeloid leukemia, such as tortuosity of veins, intraretinal or preretinal hemorrhages, and cotton–wool exudates.

Melvin D Lobo - One of the best experts on this subject based on the ideXlab platform.

  • antihypertensive effects of a central Arteriovenous Anastomosis are mediated through profound reduction in systemic vascular resistance
    Circulation-cardiovascular Interventions, 2016
    Co-Authors: Manish Saxena, Paul A Sobotka, Stephen Hamshere, Ajay N Jain, Anthony Mathur, Charles Knight, David Collier, Melvin D Lobo
    Abstract:

    Device-based therapies increase therapeutic options for the treatment of hypertension for patients who fail polypharmacy because of adverse reactions or choice. Here we report the physiology related to a device, which uniquely addresses the structural pathogenesis of hypertension. Creation of a fixed-size central Arteriovenous Anastomosis mechanically causes an immediate and significant reduction of blood pressure (BP).1 We present the first detailed hemodynamic findings before and after implantation of the ROX Coupler. A 74-year-old white female with longstanding isolated systolic hypertension complicated by multiple drug intolerances was referred for treatment of her hypertension. She could only tolerate liquid furosemide 20 mg daily, which lowered her office BP from 220/100 mm Hg to 190/90 mm Hg. She exhibited features of raised arterial stiffness with increased pulse pressure and pulse wave velocity, and it was felt that sympathomodulation would not be beneficial for BP control. An Arteriovenous Anastomosis was created using the ROX coupler, inserted in a standard catheterization laboratory setting under fluoroscopic guidance via an endovascular approach through the femoral vessels (Figure 1).2 In situ, the …

  • Effect of Arteriovenous Anastomosis on Blood Pressure Reduction in Patients With Isolated Systolic Hypertension Compared With Combined Hypertension.
    2016
    Co-Authors: Christian Ott, Neil Sulke, Paul A Sobotka, Melvin D Lobo, E Dolan, Felix Mahfoud, Alice V Stanton, John Cockcroft, Markus Van Der Giet, J Hoyer
    Abstract:

    BACKGROUND: Options for interventional therapy to lower blood pressure (BP) in patients with treatment-resistant hypertension include renal denervation and the creation of an Arteriovenous Anastomosis using the ROX coupler. It has been shown that BP response after renal denervation is greater in patients with combined hypertension (CH) than in patients with isolated systolic hypertension (ISH). We analyzed the effect of ROX coupler implantation in patients with CH as compared with ISH. METHODS AND RESULTS: The randomized, controlled, prospective ROX Control Hypertension Study included patients with true treatment-resistant hypertension (office systolic BP ≥140 mm Hg, average daytime ambulatory BP ≥135/85 mm Hg, and treatment with ≥3 antihypertensive drugs including a diuretic). In a post hoc analysis, we stratified patients with CH (n=31) and ISH (n=11). Baseline office systolic BP (177±18 mm Hg versus 169±17 mm Hg, P=0.163) and 24-hour ambulatory systolic BP (159±16 mm Hg versus 154±11 mm Hg, P=0.463) did not differ between patients with CH and those with ISH. ROX coupler implementation resulted in a significant reduction in office systolic BP (CH: -29±21 mm Hg versus ISH: -22±31 mm Hg, P=0.445) and 24-hour ambulatory systolic BP (CH: -14±20 mm Hg versus ISH: -13±15 mm Hg, P=0.672), without significant differences between the two groups. The responder rate (office systolic BP reduction ≥10 mm Hg) after 6 months was not different (CH: 81% versus ISH: 82%, P=0.932). CONCLUSIONS: Our data suggest that creation of an Arteriovenous Anastomosis using the ROX coupler system leads to a similar reduction of office and 24-hour ambulatory systolic BP in patients with combined and isolated systolic hypertension. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01642498

  • central Arteriovenous Anastomosis for the treatment of patients with uncontrolled hypertension the rox control htn study a randomised controlled trial
    The Lancet, 2015
    Co-Authors: Melvin D Lobo, Steve Furniss, Neil Sulke, Paul A Sobotka, A Stanton, E Dolan, J Hoyer, John R Cockcroft, Markus Van Der Giet, John P Foran
    Abstract:

    Summary Background Hypertension contributes to cardiovascular morbidity and mortality. We assessed the safety and efficacy of a central iliac Arteriovenous Anastomosis to alter the mechanical arterial properties and reduce blood pressure in patients with uncontrolled hypertension. Methods We enrolled patients in this open-label, multicentre, prospective, randomised, controlled trial between October, 2012, and April, 2014. Eligible patients had baseline office systolic blood pressure of 140 mm Hg or higher and average daytime ambulatory blood pressure of 135 mm Hg or higher systolic and 85 mm Hg or higher diastolic despite antihypertensive treatment. Patients were randomly allocated in a 1:1 ratio to undergo implantation of an Arteriovenous coupler device plus current pharmaceutical treatment or to maintain current treatment alone (control). The primary endpoint was mean change from baseline in office and 24 h ambulatory systolic blood pressure at 6 months. Analysis was by modified intention to treat (all patients remaining in follow-up at 6 months). This trial is registered with ClinicalTrials.gov, number NCT01642498. Findings 83 (43%) of 195 patients screened were assigned Arteriovenous coupler therapy (n=44) or normal care (n=39). Mean office systolic blood pressure reduced by 26·9 (SD 23·9) mm Hg in the Arteriovenous coupler group (p Interpretation Arteriovenous Anastomosis was associated with significantly reduced blood pressure and hypertensive complications. This approach might be a useful adjunctive therapy for patients with uncontrolled hypertension. Funding ROX Medical.

Siamak Nobacht - One of the best experts on this subject based on the ideXlab platform.

  • Peripheral retinal nonperfusion associated with chronic myeloid leukemia.
    American journal of ophthalmology, 2003
    Co-Authors: Siamak Nobacht, Kathleen F.k Vandoninck, August F. Deutman, B. Jeroen Klevering
    Abstract:

    Abstract Purpose To report a case of peripheral retinal nonperfusion and chronic myeloid leukemia in a 23-year-old woman. Design Observational case report. Methods A complete ophthalmic and systemic evaluation was performed. Results Ophthalmic examination revealed peripheral retinal nonperfusion with retinal neovascularization in both eyes. Fluorescein angiography of both eyes showed a marked midperipheral and peripheral avascular retina temporally with Arteriovenous Anastomosis and seafan neovascularizations. Blood work showed no abnormalities, although marked leucocytosis (up to 750 × 10 9 /l) and thrombocytosis (646 × 10 9 /l) were present in 1998 when the patient was diagnosed with leukemia. Following treatment, the patient has been in remission. Conclusions Peripheral retinal nonperfusion with retinal neovascularization may occur as a complication of chronic myeloid leukemia. In contrast to other studies describing this association, our patient had a bilateral peripheral retinal nonperfusion with seafan neovascularizations without relapse of the myeloid leukemia and without any of the other retinal signs associated with chronic myeloid leukemia, such as tortuosity of veins, intraretinal or preretinal hemorrhages, and cotton–wool exudates.