Central arteriovenous anastomosis for the treatment of patients with uncontrolled hypertension (the ROX CONTROL HTN study): a randomised controlled trial

Lobo, Melvin D.; Sobotka, Paul; 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; Ott, Christian; Schmieder, Roland E.

doi:10.1016/s0140-6736(14)62053-5

Cited by 164 publications

(118 citation statements)

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“…It was anticipated that ≈25 patients would qualify to proceed from the Run‐In phase to the PHC Hypertension Therapy phase and complete the study. With an assumed 15 mm Hg SD of changes observed in prior studies,7, 10 the study was able to detect a mean reduction of 9 mm Hg or greater in 24hASBP with a power of ≈80%. To compare the incidences of atrial fibrillation between observed on 24‐hour Holter monitoring between baseline and 1 month, a 2‐sided McNemar test for the difference between correlated proportions was used.…”

Section: Methodsmentioning

confidence: 80%

“…This has motivated the investigation of nonpharmacologic approaches 7, 10, 11, 12. The present study investigated the safety and efficacy of a pacemaker‐based therapy that takes advantage of the fact that ventricular pressure generation is preload dependent and that preload can be manipulated by altering atrioventricular pacing delay.…”

Section: Discussionmentioning

confidence: 99%

“…These include baroreceptor activation therapy,17, 18, 19 renal denervation,7, 20 arteriovenous shunting,10, 21 carotid body resection or denervation,12, 22 and mechanical stimulation of the baroreceptors 23. Prior review articles have provided overviews and comparisons of these different approaches and will not be repeated here,24, 25 other than to say that treatment of isolated systolic hypertension (ie, patients with office diastolic blood pressure <90 mm Hg), which is characterized by increased vascular stiffness, has proved to be particularly challenging for some of these approaches, with such patients excluded from the recently complete SPYRAL HTN‐OFF MED study 19, 26.…”

Section: Discussionmentioning

confidence: 99%

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Pacemaker‐Mediated Programmable Hypertension Control Therapy

Neužil

Merkely

Ērglis

et al. 2017

JAHA

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BackgroundMany patients requiring a pacemaker have persistent hypertension with systolic blood pressures above recommended levels. We evaluated a pacemaker‐based Programmable Hypertension Control (PHC) therapy that uses a sequence of variably timed shorter and longer atrioventricular intervals.Methods and ResultsPatients indicated for dual‐chamber pacing with office systolic blood pressure (oSBP) >150 mm Hg despite stable medical therapy were implanted with a Moderato™ pulse generator that delivers PHC therapy. Patients were followed for 1 month (Run‐In period) with conventional pacing; those with persistent oSBP >140 mm Hg were included in the study and had PHC therapy activated. The co‐primary efficacy end points were changes in 24‐hour ambulatory systolic blood pressure and oSBP between baseline and 3 months. Safety was assessed by tracking adverse events. Thirty‐five patients met the initial inclusion criteria and underwent Moderato implantation. At 1 month, oSBP was <140 mm Hg in 7 patients who were excluded. PHC was activated in the remaining 27 patients with baseline office blood pressure 166±11/80±10 mm Hg despite an average of 3.2 antihypertensive medications. During the Run‐In period, oSBP and 24‐hour ambulatory systolic blood pressure decreased by 8±13 and 5±12 mm Hg (P<0.002), respectively. Compared with pre‐PHC activation measurements, oSBP decreased by another 16±15 mm Hg and 24‐hour ambulatory systolic blood pressure decreased by an additional 10±13 mm Hg (both P<0.01) at 3 months. No device‐related serious adverse effects were noted.ConclusionsIn pacemaker patients with persistent hypertension despite medical therapy, oSBP and 24‐hour ambulatory systolic blood pressure are decreased by PHC therapy. Initial indications are that this therapy is a safe and promising therapy for such patients.Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT02282033.

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Section: Methodsmentioning

confidence: 80%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Pacemaker‐Mediated Programmable Hypertension Control Therapy

Neužil

Merkely

Ērglis

et al. 2017

JAHA

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“…For this purpose it is necessary to conduct additional studies cycle. It looks promising engineering solution: the installation on the testimony of artificial anastomosis (shunt) [20]. For example, setting the modified device type «ROX AV Coupler» company ROX Medical.…”

Section: Comparison Of Two Theories: the Theory Of Qigong And The Newmentioning

confidence: 99%

The new theory of cancer complements ancient Chinese Qigong therapy

Ermoshkin¹

2017

Hypertens Curr Concepts Ther

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Goal: The death rate from cancer is ranked second in the world after the death from cardiovascular disease (CVD). The official medicine it is believed that the causes of cancer are many. This article describes an updated view of the mechanism of occurrence of cancer, which is almost the same as the qigong therapy, but with an important addition. Methods:Finding information in the literature, participation in medical conferences in Russia (2012Russia ( -2016, in Australia (Brisbane "Arrhythmia-2016"), correspondence with scientists, discussions with leading Russian cardiologists, publication of articles. Results:It was possible to show that the study of cancer of reasons in terms of a new theory and from the point of view of the ancient Chinese Tai Chi-Qigong therapy is almost identical. The only difference is that in the new theory, compared with Qigong Tai Chi, there is an important addition to the existence in the human cardiovascular system periodically opens major arteriovenous anastomoses and some correction treatment of the underlying causes of the disease. Conclusions:With the proposed theory, and taking into account the findings of ancient Chinese medicine is possible in the near future be able to move forward in the knowledge of the main causes of morbidity certain types of cancer and its treatment.

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“…Most of these new technologies target sympatho‐modulation either through renal nerve ablation (renal denervation or RDN) or through electrical carotid sinus stimulation (baroreflex activation therapy), although other technologies may target mechanical aspects of the circulation through the creation of a central iliac arteriovenous anastomosis 2, 3, 4, 5, 6, 7. At present, RDN has been studied the most and is thought to lower blood pressure (BP) by reducing central sympathetic drive and in turn, reducing sympathetic outflow to kidneys 8, 9…”

mentioning

confidence: 99%

Attenuation of Splanchnic Autotransfusion Following Noninvasive Ultrasound Renal Denervation: A Novel Marker of Procedural Success

Saxena

Shour

Shah

et al. 2018

JAHA

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BackgroundRenal denervation has no validated marker of procedural success. We hypothesized that successful renal denervation would reduce renal sympathetic nerve signaling demonstrated by attenuation of α‐1‐adrenoceptor‐mediated autotransfusion during the Valsalva maneuver.Methods and ResultsIn this substudy of the Wave IV Study: Phase II Randomized Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension, we enrolled 23 subjects with resistant hypertension. They were randomized either to bilateral renal denervation using therapeutic levels of ultrasound energy (n=12) or sham application of diagnostic ultrasound (n=11). Within‐group changes in autonomic parameters, office and ambulatory blood pressure were compared between baseline and 6 months in a double‐blind manner. There was significant office blood pressure reduction in both treatment (16.1±27.3 mm Hg, P<0.05) and sham groups (27.9±15.0 mm Hg, P<0.01) because of which the study was discontinued prematurely. However, during the late phase II (Iii) of Valsalva maneuver, renal denervation resulted in substantial and significant reduction in mean arterial pressure (21.8±25.2 mm Hg, P<0.05) with no significant changes in the sham group. Moreover, there were significant reductions in heart rate in the actively treated group at rest (6.0±11.5 beats per minute, P<0.05) and during postural changes (supine 7.2±8.4 beats per minute, P<0.05, sit up 12.7±16.7 beats per minute, P<0.05), which were not observed in the sham group.ConclusionsBlood pressure reduction per se is not necessarily a marker of successful renal nerve ablation. Reduction in splanchnic autotransfusion following renal denervation has not been previously demonstrated and denotes attenuation of (renal) sympathetic efferent activity and could serve as a marker of procedural success.Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT02029885.

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Central arteriovenous anastomosis for the treatment of patients with uncontrolled hypertension (the ROX CONTROL HTN study): a randomised controlled trial

Cited by 164 publications

References 35 publications

Pacemaker‐Mediated Programmable Hypertension Control Therapy

Pacemaker‐Mediated Programmable Hypertension Control Therapy

The new theory of cancer complements ancient Chinese Qigong therapy

Attenuation of Splanchnic Autotransfusion Following Noninvasive Ultrasound Renal Denervation: A Novel Marker of Procedural Success

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