Creation of an Arteriovenous Fistula to Treat Hypertension

Size: px

Start display at page:

Download "Creation of an Arteriovenous Fistula to Treat Hypertension"

Damian Walker
5 years ago
Views:

1 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

2 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,

3 How this started.

4 How this started. ROX Coupler device - Developed by Rodney Brenneman and the Rox Medical team FIM Dec in Costa Rica - Dr. Guillermo Elizondo, Monterrey, Mexico

5 How this started. I learned about this only in Dan Miller, Rodney Brenneman, John Faul

6 The Concept To Create an Arteriovenous Fistula to utilize Cardiovascular Reserve to Overcome A Respiratory Insufficiency Improved Oxygenation

7 Before Room air, 750 mmhg po 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

8 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

9 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

10 Immediate BP reduction -28/-15 mmhg Systolic BP ( mmhg ) ~72 Diastolic BP ~60 ( mmhg )

13 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

15 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= Statistically significant at all points p-values 3, 6, 9 and 12m < ; 24m < 0.015

16 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= Statistically significant at all points p-values 3, 6 and 12m <

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

17 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= Statistically significant at all points p-values 3, 6, 9 and 12m <

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.

18 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= p-values 3, 6 and 12m < Statistically significant at all points

20 Number of Patients Venous stenosis occurs in first 12 mo treatable with venous stent HTN Trials RH-01 and RH-02: Coupler Implant n= Stenosis Free (%) Target right leg venous stenosis rate is m 6m 9m 12m 15m 18m 21m 24m # Patients New Onset Cumulative Incidence (%) 100% 80% 60% 40% 20% 0% Months post-coupler placement to onset

21 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%) Events related to worsening in BP Serious events: Events Patients Events Patients Hypertensive crisis 0 0 (0%) 5 4 (10.3%) 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%) Not included above, one Control group death related to hypertension at month 8

22 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

23 Thank you!

Avoiding and Managing Complications During CAS: Lessons Learned

LINC 2019 Leipzig, Germany, Jan 22-25, 2019 Avoiding and Managing Complications During CAS: Lessons Learned Horst Sievert, Ilona Hofmann, Kolja Sievert, Laura Vaskelyte, Sameer Gafoor, Stefan Bertog, Predrag