Central Iliac Arteriovenous Anastomosis for Uncontrolled Hypertension

Lobo, Melvin D.; Ott, Christian; Sobotka, Paul A.; Saxena, Manish; Stanton, Alice; Cockcroft, John R.; Sulke, Neil; Dolan, Eamon; Giet, Markus van der; Hoyer, Joachim; Furniss, Stephen S.; Foran, John P.; Witkowski, Adam; Januszewicz, Andrzej; Schoors, Danny; Tsioufis, Κonstantinos; Rensing, Benno J.; Scott, Benjamin; Ng, G. André; Schmieder, Roland E.

doi:10.1161/hypertensionaha.117.10142

Cited by 45 publications

(28 citation statements)

References 31 publications

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“…The benefit of AV anastomosis in RHT has been investigated in prospective, randomized, controlled ROX-CONTROL HNT study. Despite a significant decrease in BP at 6 months and 1 year, a remarkable number of patients developed venous iliac stenosis related to the procedure ( 145 , 146 ). Moreover, the effects of a permanent AV shunt on cardiac hemodynamics is not known.…”

Section: Introductionmentioning

confidence: 99%

Turkish Society of Cardiology Consensus Paper on Evaluation and Treatment of Resistant Hypertension

et al. 2020

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Section: Introductionmentioning

confidence: 99%

Turkish Society of Cardiology Consensus Paper on Evaluation and Treatment of Resistant Hypertension

et al. 2020

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“…However, the effects on cardiac output and central haemodynamics, as well as the long‐term safety of the procedure, were not assessed. [ 29 ]…”

Section: Introductionmentioning

confidence: 99%

Cost-effectiveness of Interventional therapies for management of Treatment-resistant hypertension: systematic review of pharmacoeconomic studies

Sorato¹,

Davari

Kebriaeezadeh

et al. 2020

Journal of Pharmaceutical Health Services Research

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Background Treatment resistant hypertension (TRH) is defined as uncontrolled blood pressure (>140/90 mm Hg) after treatment with the intensified dose of three standard antihypertensive drugs. Management of TRH involves addition of fourth line drugs on standard care or interventional therapies (Renal denervation, Baroreceptor activation, Central venous anastomosis). However, evidence concerning cost‐effectiveness of interventional therapies is inconclusive. Objective: This systematic review was conducted to extract the level of evidence on cost‐effectiveness of interventional therapies for TRH. Method We systematically searched articles written in English language since January 2000 to January 2020 from the following databases: PubMed/Medline, Ovid/Medline, Embase, Scopus, Web of Science, Google scholar and other relevant sources. Key findings Twelve pharmacoeconomic studies were included in this systematic review. Renal denervation (RDN) is the most commonly studied intervention therapy for treatment of TRH. Participants included in the study vary from age 18‐99 years. The incremental cost‐effectiveness ratio (ICER) of RDN ranged from $1,709.84 per QALY gained in Netherlands to 66,380.3 per QALY gained in Australia. RDN was cost‐effective in high‐risk patients in UK, Australia, Canada, Netherlands, USA, Germany, Russia and Korea. The cost‐effectiveness was influenced by the magnitude of effect of RDN on systolic blood pressure, the rate of RDN nonresponders, and the procedure costs of RDN and assumption of long‐term time horizon. However, the ICER of RDN in Mexico was above MXN$ 139,000 GDP/capita of the country. The ICER of implantable carotid body stimulator was $64,400 per QALYs gained. The cost‐effectiveness of baroreceptor activation didn’t improve with age. Conclusion Overall cost‐effectiveness of interventional therapies for treatment of TRH was inconclusive based on the current available evidence. Therefore, strong clinical trials and pharmacoeconomic evaluations from different perspectives in various candidate populations are needed to generate adequate clinical and cost‐effectiveness evidence for using interventional therapies in treatment of treatment resistant hypertension.

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“…A central iliac arteriovenous anastomosis has been shown to alter mechanical arterial properties and reduce blood pressure (BP) in patients with resistant and/or uncontrolled hypertension . The coupler was first used to treat hypertension in 2012 and adds a low‐resistance, high‐compliance venous segment to the central arterial tree . The device is associated with an immediate and significant reduction in BP and reduces the risk of hospitalized hypertensive crises …”

Section: Introductionmentioning

confidence: 99%

The hemodynamic effects of a central iliac arteriovenous anastomosis at 6 months in patients with resistant and uncontrolled hypertension

Eysenck

Zalen

Freemantle

et al. 2019

J of Clinical Hypertension

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A central iliac arteriovenous anastomosis, termed the "coupler" (ROX Medical), results in a significant reduction in blood pressure (BP) in hypertensive patients. This study assessed functional and hemodynamic changes induced by the device. Twenty-one patients with resistant and/or uncontrolled hypertension underwent stress echocardiography and cardiopulmonary exercise testing (CPET) at baseline and 6 months post-coupler implantation. End points were selected to best evaluate cardiac function including Doppler stroke volume (SV), septal and lateral E/E′, and right ventricular systolic velocity S′ (RV S′). CPET VO 2 peak demonstrated total cardiopulmonary performance. SV increased from 76.4 SD12.2 mL to 92.1 SD22.7 mL 6 months postcoupler insertion; P = .002. No changes in RV S′, septal or lateral E/E′, or VO 2 peak were observed. Five patients experienced increased diuretic requirement ≥3 times baseline. RV S′ fell from 19.0 SD1.87 cm/s to 16.80 SD3.43 cm/s in these patients (P > .05). A significant increase in SV 6 months post-coupler insertion was observed.In patients with increased diuretic requirement, the device was associated with a lower RV S′ suggesting occult RV dysfunction as the mechanism of this pre-specified adverse outcome. |EYSENCK Et al. changes and detailed assessment of these with CPET stress echo predicts patients at risk of increased diuretic requirement post-coupler insertion. | ME THODS | Study design and participantsThis study was performed at Eastbourne General Hospital, East Sussex Healthcare NHS Trust, UK, and was approved by the UK national ethics committee. Twenty-one consecutive participants with resistant and/or uncontrolled hypertension taking part in the ROX Control Hypertension Registry (RH-03) NCT01885390 were included. 10 The rationale and design of the RH-03 registry have been described previously. 10 Inclusion criteria were patients aged 18-85 years with a diagnosis of resistant or uncontrolled hypertension made on the basis of office and 24-hour BP monitoring, medical history, and physical examination. Resistant hypertension was defined as patients with established hypertension (diagnosed ≥12 months prior to baseline) on a guideline-based drug regimen at a stable and a fully tolerated dose, consisting of ≥3 hypertensive medications (including 1 diuretic). Uncontrolled hypertension was defined as patients with hypertension and drug intolerances to antihypertensive medications and unable to take a guideline-based drug regimen. Patients were excluded if they had any serious medical condition that might have adversely affected the patient's safety, limit the subject's ability to participate in the registry, comply with follow-up requirements, or impact the scientific integrity of the study. In addition, patients were excluded if found to have a baseline pulmonary capillary mean wedge pressure >15 mm Hg at right heart catheterization. Written informed consent was obtained from all participants. All 21 participants underwent baseline and 6 months post-coupler stress echo CPET ex...

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Central Iliac Arteriovenous Anastomosis for Uncontrolled Hypertension

Abstract: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01642498.

Cited by 45 publications

References 31 publications

Turkish Society of Cardiology Consensus Paper on Evaluation and Treatment of Resistant Hypertension

Turkish Society of Cardiology Consensus Paper on Evaluation and Treatment of Resistant Hypertension

Cost-effectiveness of Interventional therapies for management of Treatment-resistant hypertension: systematic review of pharmacoeconomic studies

The hemodynamic effects of a central iliac arteriovenous anastomosis at 6 months in patients with resistant and uncontrolled hypertension

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