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.
CaseA 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 coupler creates a fixed-caliber 4 mm conduit between the external iliac artery and vein, transferring 0.8 L/min of blood from the arterial to the venous compartment. The hemodynamic changes in relation to coupler placement were evaluated with left and right heart catheterization, pulse wave velocity, office BP, and ambulatory BP measurement (Tables 1-3). The opening of the arteriovenous coupler immediately leads to a large reduction in mean arterial pressure of 13% because of a profound reduction in systemic vascular resistance (SVR) by 38% on the table (Figure 2). In tandem, there are increases in stroke volume (24%), cardiac output (39%), and HR (14%) because of the proximal arteriovenous shunt. Of note, pulmonary vascular resistance was seen to immediately decline (−46%), despite an increase in pulmonary flow possibly because of improved central oxygenation. At 6-months post anastomosis formation, repeat catheterization demonstrated greater reductions in SVR (−50%) and mean arterial pressure (−24%) compared with baseline, accompanied by further increase in cardiac output (46%), stroke volume (67%), and pulmonary vascular resistance (53%). There were also large, immediate (1-day postcoupler) and durable (6-months post-coupler) reductions in office BP and ambulatory BP parameters at 6-months, with no change to the baseline medication regimen and no change in exercise capacity. The reduction in weight of 1 kg (2%) suggests that total body volume is largely unchanged after central arteriovenous anastomosis.
DiscussionThe opening of the 4-mm, fixed diameter, central arteriovenous conduit leads to utilization of a proximal, low resistance, high compliance central venous segment in parallel with the aorta and results in an immediate and significant reduction in SVR (−38% with coupler opening and −50% at...