{"id":46685,"date":"2015-01-22T19:23:32","date_gmt":"2015-01-23T00:23:32","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&p=46685"},"modified":"2015-01-22T19:33:52","modified_gmt":"2015-01-23T00:33:52","slug":"new-device-to-lower-resistant-hypertensive-shows-early-promise","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2015\/01\/22\/new-device-to-lower-resistant-hypertensive-shows-early-promise\/","title":{"rendered":"New Device to Lower Resistant Hypertension Shows Early Promise"},"content":{"rendered":"

A novel implantable device appears to show early promise in the treatment of resistant hypertension. The “Coupler” device from ROX Medical is about the size of a paper clip and is delivered via a catheter to the upper thigh, where it creates an anastomosis between the distal external iliac vein and artery, thereby mechanically lowering blood pressure.<\/p>\n

In a paper published in the\u00a0Lancet<\/em><\/a>, European investigators report the results of an open-label trial in in which 83 patients with persistent high blood pressure despite taking multiple antihypertensive drugs were randomized to implantation of the Coupler device or current treatment. After six months there were large and highly significant reductions in blood pressure in the treatment group but not in the control group: systolic BP measured in the office decreased by 26.9 mm Hg in the treatment group versus 3.7 mm Hg in the control group; systolic blood pressure measured by a 24-hour ambulatory monitor decreased 13.5 mm Hg in the treatment group versus 0.5 mm Hg in the control group. The same pattern was evident in the group of 17 who\u00a0had previously undergone renal denervation.<\/p>\n

Twenty-nine percent of patients who received the device developed edema in the leg caused by venous stenosis, which was treated with venoplasty or stenting. Three patients in the control group and none in the treatment group were admitted to the hospital for a hypertensive crisis.<\/p>\n

In their discussion the investigators pointed out that, unlike renal denervation as it has been performed in the past, “technical success with the arteriovenous coupler is documented during the procedure and is associated with an immediate fall in blood pressure.\u00a0This difference eliminates the placebo effect and isolates the sham effect to an interaction between a patient\u2019s knowledge of treatment allocation with longer-term clinical behaviors.”\u00a0In a press statement, Melvin Lobo, the study principal investigator, said:<\/p>\n

This is an entirely new and highly promising concept in high blood pressure treatment. Existing drugs focus on hormonal or neurological regulation of blood pressure, and newer treatments such as renal denervation are uniquely centered on the renal nervous system. The Coupler effectively targets the mechanical aspects of how blood circulation works\u00a0\u2014 so it’s a totally new approach to controlling blood pressure. The Coupler also highlights the importance of arterial stiffness as a major cause of resistant high blood pressure and it targets this issue both safely and successfully. Once the Coupler is placed, the results are also immediate, which again is unique to this treatment.”<\/p><\/blockquote>\n

Hypertension experts Franz Messerli and Sripal Bangalore offered the following comment:<\/p>\n

This is an exceedingly provocative study identifying a novel mechanism to treat hypertension. By creating an arterio-venous anastomosis with an\u00a0arterio-venous coupler, the investigators create an additional big branch in a stiff arterial tree, thereby improving\u00a0 overall arterial compliance, restoring the Windkessel function and of course, lowering peripheral resistance and blood pressure. In contrast to renal denervation, this innovative technique is straightforward and easy to understand. However, as fascinating as such an approach\u00a0 of \u201cletting off steam\u201d in a high pressure system seems\u00a0at a first glance, a few items will have to be scrutinized. Most important will be the long-term sequelae to the local venous system that now will have to bear the brunt of a potentially destructive hemodynamic burden. Could several small shunts possibly be better tolerated than a single large one? Are we setting the stage for a high-output heart failure situation?\u00a0 And of course after the sobering results of Symplicity HTN-3, we have become skeptical about interventional studies without a sham control. Finally, if this really were to work, shouldn\u2019t there be little or no hypertension in\u00a0our dialysis patients with arterio-venous fistula?”<\/p><\/blockquote>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

A novel implantable device appears to show early promise in the treatment of resistant hypertension. The “Coupler” device from ROX Medical is about the size of a paper clip and is delivered via a catheter to the upper thigh, where it creates an anastomosis between the distal external iliac vein and artery, thereby mechanically lowering […]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,9,7],"tags":[1480,454,581,921],"class_list":["post-46685","post","type-post","status-publish","format-standard","hentry","category-general","category-interventional-cardiology","category-prevention","tag-antihypertensive-drugs","tag-hypertension","tag-renal-denervation","tag-resistant-hypertension"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/46685","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/196"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=46685"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/46685\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=46685"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=46685"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=46685"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}