Creation of an Arteriovenous Fistula to Treat Hypertension Horst Sievert, Ilona Hofmann, Laura Vaskelyte, Sameer Gafoor, Stefan Bertog, Predrag Matić, Markus Reinartz, Bojan Jovanovic, Kolja Sievert CardioVascular Center Frankfurt - CVC, Frankfurt, Germany
Potential conflicts of interest Speaker's name: Horst Sievert I have the following potential conflicts of interest to report: Study honoraria, travel expenses, consulting fees : Abbott, Ablative Solutions, Acoredis, Ancona Heart, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, CardioKinetix, Celonova, Cibiem, CGuard, Coherex, Comed B.V., Contego, CSI, CVRx, ev3, Gardia, Hemoteq, InspireMD, Kona Medical, Lifetech,
How this started.
How this started. ROX Coupler device - Developed by Rodney Brenneman and the Rox Medical team FIM Dec. 2003 in Costa Rica - Dr. Guillermo Elizondo, Monterrey, Mexico
How this started. I learned about this only in 2005 - Dan Miller, Rodney Brenneman, John Faul
The Concept To Create an Arteriovenous Fistula to utilize Cardiovascular Reserve to Overcome A Respiratory Insufficiency Improved Oxygenation
Before Room air, 750 mmhg po 2 150 mmhg After Room air, 750 mmhg po 2 =150 mmhg O 2 in Alveola = 150 O 2 in Alveola = 150 Pulmonary artery Ppa02 = 28 Pulmonary artery Ppa02 = 45 Pa02 = 55 Pa02 PaO 2 =?? 65 Vena Pv02 = 30 Tissue Pa02 = 50 Vena Pv02 = 45 Tissue Pa02 =?? 60 Tissue O 2 Extraction Tissue O 2 Extraction
Did it work in COPD? We had been busy with - angioplasty/stenting of iliac vein stenoses - closing fistulas - explaining that and why the procedure did not help
The revival of the procedure The Rox Medical team realized and told me that some COPD patients who had also hypertension showed a fall in blood pressure Creating an av-shunt made sense in hypertensive patients with "stiff arteries" But I could not believe in the concept because I had all the complications and failures in COPD patients in mind
Immediate BP reduction -28/-15 mmhg 186-180 Systolic BP ( mmhg ) 150-153 ~72 Diastolic BP ~60 ( mmhg )
Randomized Lancet Trial Prospective, randomized 1:1, controlled N = 83 Stable on 3 meds including a diuretic Office BP >140 mmhg and ABMP >135/85 mmhg Medications vs. medications + ROX Coupler Primary endpoints - Changes in Office BP - Changes in ABPM Safety outcomes - Procedure complications - Late AE s or SAE s
Change from baseline (mm Hg) Randomized RH-02: Change in Office BP Systolic BP Diastolic BP 3 Mo n=42 6 Mo n=42 AV Coupler Group 9 Mo n=38 12 Mo n=38 24 Mo n=9 Control Group 3 Mo n=33 6 Mo n=34 20 10 0-10 -20-30 -40-50 -60-21.4-15.6-26.9-20.1-22.1-18.4-25.4-21.1-30.3-7.4-3.8-3.7-2.4-70 -80-32.3 Statistically significant at all points p-values 3, 6, 9 and 12m < 0.0001; 24m < 0.015
Change from baseline (mm Hg) Change in 24-h Ambulatory BP Systolic BP Diastolic BP 3 Mo n=41 AV Coupler Group 6 Mo n=42 12 Mo n=37 24 Mo n=5 Control Group 3 Mo n=32 6 Mo n=35 20 10 0-10 -20-1.3-1.5-0.1-0.5-30 -14.0-13.5-15.7-13.5-12.8-15.6-12.4-16.8-40 -50 Statistically significant at all points p-values 3, 6 and 12m < 0.0001
Change from baseline (mm Hg) Systolic BP Diastolic BP Change in Office BP: Prior Renal Denervation subset 3 Mo n=10 6 Mo n=10 AV Coupler Group 9 Mo n=9 12 Mo n=9 24 Mo n=2 Control Group 3 Mo n=5 6 Mo n=6 30 20 3.1 3.2 10 0.5 0-10 -20-30 -40-50 -60-70 -80-15.9-18.6-25.2-21.6-24.2-24.8-30.7-34.3 Statistically significant at all points p-values 3, 6, 9 and 12m < 0.005-44.8-37.8-4.6
Change from baseline (mm Hg) Systolic BP Diastolic BP Change in 24-h Ambulatory BP Prior Renal Denervation Subset 3 Mo n=10 AV Coupler Group 6 Mo n=10 12 Mo n=9 24 Mo n=2 Control Group 3 Mo n=5 6 Mo n=6 30 20 4.4 5.2 4.4 5.2 10 0-10 -20-30 -14.7-16.4-13.6-14.6-12.4-14.4-21.5-40 -50 p-values 3, 6 and 12m < 0.02-21.5 Statistically significant at all points
Number of Patients Venous stenosis occurs in first 12 mo treatable with venous stent 50 45 40 35 30 25 20 15 10 5 0 2 6 HTN Trials RH-01 and RH-02: Coupler Implant n=61 5 2 Stenosis Free (%) Target right leg venous stenosis rate is 20 0 3m 6m 9m 12m 15m 18m 21m 24m # Patients New Onset Cumulative Incidence (%) 100% 80% 60% 40% 20% 0% Months post-coupler placement to onset
ROX significantly reduced medications and hypertension related hospitalizations Events related to improvement in BP ROX Coupler (n = 42) Control Group (n = 39) p-value Non-serious events: Events Patients Events Patients Desired medication reduction Hypotensive symptoms permitting reduction in antihypertensive meds 8 8 (19.0%) 0 0 (0%) 0.0056 Events related to worsening in BP Serious events: Events Patients Events Patients Hypertensive crisis 0 0 (0%) 5 4 (10.3%) 0.0101 Non-serious events: Worsening BP requiring increase in medication 1 1 (2.4%) 4 4 (10.3%) TOTAL 1 1 (2.4%) 10 8 (20.5%) 0.0027 Not included above, one Control group death related to hypertension at month 8
Conclusions Creating an av-shunt causes a blood pressure decrease and a decrease in hypertension associated complications in uncontrolled hypertension This effect is maintained for at least 12 mo Complications include venous stenoses / edema but they are manageable This is one of the very few device based therapies which is reversible
Thank you!