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Iliac vein stenosis after implantation of a central arteriovenous coupler device in the treatment of therapy resistant arterial hypertension

Journal of Human Hypertension volume 32, pages 691–692 (2018)Cite this article

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Device-based treatment of therapy resistant hypertension (TRH) was investigated by Lobo et al., in the ROX CONTROL HTN randomized trial [1, 2], where creation of a fixed diameter shunt between the external iliac artery and vein was compared to medical treatment alone. An immediate and persisting blood pressure (BP) lowering effect was observed during a twelve month follow-up period after implantation of this central arteriovenous (cAV) ROX Coupler device (ROX Medical, San Clemente, CA, USA). A striking 33% of patients treated with this device developed, however, an iliac venous stenosis [2]. In this correspondence we want to address on clinical presentation, diagnosis, and treatment of cAV coupler associated venous stenosis by presenting two cases, to emphasize the need for further investigation on this late and not uncommon complication.

The second case concerns a 58-year old female with cAV coupler device implantation for TRH (office BP 182/95 mmHg; 24-h mean BP 163/84 mmHg) despite treatment with five antihypertensive drugs, prior renal denervation and baroreceptor stimulation. At six-month follow-up the patient complained of right sided leg pain during physical exertion. BP control over the same period was stable. Doppler study of the anastomosis site was inconclusive, but contrast computed tomography revealed a short, tight lesion of the external iliac vein. Venography confirmed stenosis at the level of the fistula (Fig. 1d). Immediate venoplasty and a self-expanding nitinol stent (16 × 60 mm) was deployed, overlapping the cAV coupler device (Fig. 1e), with remaining functionality of the shunt. The patient was discharged without incident the same day. One month post-procedure the patient had resumed normal exercise activities without residual complaints, with office BP at 142/75 mmHg.

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Fig. 1

References

  1. Lobo MD, Sobotka PA, Stanton A, et al. Central arteriovenous anastomosis for the treatment of patients with uncontrolled hypertension (the ROX CONTROL HTN study): a randomized controlled trial. Lancet. 2015;385:1634–41.

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  2. Lobo MD, Ott C, Sobotka PA, et al. Central iliac arteriovenous anastomosis for patients with uncontrolled hypertension: 1 year results from the ROX CONTROL HTN randomized controlled trial. Hypertension. 2017;70:1099–105.

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Authors and Affiliations

  1. ZNA Hartcentrum, Lindendreef 1, 2020, Antwerp, Belgium

    Liesbeth Rosseel & Benjamin Scott

  2. ROX Medical, 150 Calle San Iglesia, San Clemente, CA, 92672, USA

    Peter Balmforth & Paul Sobotka

  3. CVC Frankfurt, Seckbacher Landstraße, 60389, Frankfurt, Germany

    Horst Sievert

Authors
  1. Liesbeth Rosseel
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  2. Benjamin Scott
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  3. Peter Balmforth
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  4. Paul Sobotka
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  5. Horst Sievert
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Corresponding author

Correspondence to Liesbeth Rosseel.

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Conflict of interest

PB is employed at ROX Medical. PS is employed at ROX Medical. HS has received study honoraria, consulting fee or travel expenses of 4tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Bavaria Medizin, Technologie GmbH, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Celonova, Cibiem, CGuard, Comed B.V., Contego, CVRx, Edwards, Endologix, Hemoteq, InspireMD, Lifetech, Maquet Getinge Group, Medtronic, Mitralign, Nuomao Medtech, Occlutech, pfm Medical, Recor, Renal Guard, Rox Medical, Terumo, Vascular Dynamics, Vivasure Medical, Venus, Veryan. The other authors declare that they have no conflict of interest.

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Rosseel, L., Scott, B., Balmforth, P. et al. Iliac vein stenosis after implantation of a central arteriovenous coupler device in the treatment of therapy resistant arterial hypertension. J Hum Hypertens 32, 691–692 (2018). https://doi.org/10.1038/s41371-018-0090-x

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