Preliminary Results of RETREAT

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1 LINC 2015 Leipzig, Germany, Jan 27-30, 2015 Preliminary Results of RETREAT (Renal Denervation with Ultrasound After Failed Radiofrequency Denervation) Horst Sievert, Jan Philipp Kulow, Stefan Bertog, Predrag Matić, Sameer Gafoor, Ilona Hofmann, Laura Vaskelyte, Markus Reinartz CardioVascular Center Frankfurt - CVC, Frankfurt, Germany

2 There are many potential reasons why renal denervation may fail: Renal denervation may not work at all Changes in medication - before the procedure - during follow-up Patient specific factors - type of medication - race Procedural technical issues - not enough or incomplete ablations - ablation not circumferential Technology not good enough to destroy all renal nerves in all patients

3 Renal Denervation with Ultrasound As with RF energy, renal denervation is achieved by inducing thermal necrosis Ultrasound energy passes through fluids and generates frictional heating in soft tissues Unlike RF, no direct tissue contact required - Stability is less of an issue

4 Ultrasound: Recor Medical Ultrasound transducer mounted inside of a low pressure balloon Cooled water in the balloon protects the endothelium against heat 30 seconds of circumferential heating CE mark

5 REDUCE: Office Systolic Blood Pressure (93% Responder Rate) 0 mm Hg -10 mm Hg mm Hg -17 Systolic -30 mm Hg Diastolic mm Hg 2 weeks (n = 15) 1 month (n = 15) 2 months (n = 15) 3 months (n = 15) 6 months (n = 15) Source: Company Data

6 Purpose of RETREAT To evaluate the effect of renal denervation with ultrasound (Recor system) after failed denervation with radiofrequency (Symplicity)

7 RETREAT Physician initiated prospective multi-center study No funding N = 30 Enrolment clashed with - the publication of HTN-3 - stop of reimbursement for renal denervation in Germany - decline in referals for renal denervation - new treatment modalities for hypertension Enrolment was very low and almost stopped Study results are not conclusive but still some interesting observations

8 RETREAT Inclusion Criteria First renal denervation with Symplicity 12 months prior to study participation "Non-responder" - BP < 10mmHg or - BP still high (> 160mmHg) Systolic Office BP 140mmHg Optimal medical therapy - 3 or more antihypertensive drugs including one diuretic, all at max. tolerated dose Secondary hypertension was ruled out

9 RETREAT Endpoints Primary Endpoints: - change in office and ambulatory blood pressure 12 months after the procedure - decrease in antihypertensive medication Secondary Endpoint: - Freedom from adverse events

10 RETREAT Examination schedule Baseline: - OBP, ABPM - Blood test: Creatinine - MRI/angiographic evaluation to rule out renal artery abnormalities Follow up after 1, 3, 6 and 12 months: - OBP, ABPM - Changes in medication - Adverse events Renal duplex ultrasound after 6 months Creatinine after 6 and 12 months

11 Prior Renal Denervation Procedure with Radiofrequency Radiofrequency RDN with the Medtronic Symplicity Catheter Both renal arteries were treated in each patient - Circumferential ablation (14.5) ablations per patient No adverse events occurred during the procedure OBP after 6 months - Decrease of less than 10mmHg and/or - OBP >160 mmhg

12 RETREAT Procedure N = 8 Ultrasound Renal Denervation with the Recor Paradise System 2-3 (2.3) ablations per artery Technical success in all patients No device related adverse events One false occured in one patient No changes in Creatinine levels

13 Office Blood Pressure Systolic change Diastolic change M 3M 6M 12M n=3 n=6 n=7 n=1 Follow up Mean OBP n Baseline 171/87mmHg 9 1 month 150/80mmHg 3 3 months 154/84mmHg 6 6 months 175/89mmHg 7 12 months 171/94mmHg 1

14 Ambulatory Blood Pressure Systolic change Diastolic change M 3M 6M 12M n=4 n=6 n=6 n=4 Follow up Mean ABP n Baseline 158/87mmHg 9 1 month 143/77mmHg 4 3 months 145/77mmHg 6 6 months 152/82mmHg 6 12 months 154/78mmHg 4

15 Conclusions Enrolment in this trial has been too slow due to a number of reasons Renal denervation with ultrasound (Recor system) after prior denervation with radiofrequency seems to be safe After an initial decrease of BP after one month we observed an increase in blood pressure which has not been seen in other renal denervation studies Renal denervation with ultrasound (Recor system) may be effective in patients with resistant hypertension who failed to respond to renal denervation with the Symplicity system The study is too small to draw valid conclusions

16 LINC 2015 Leipzig, Germany, Jan 27-30, 2015 Preliminary Results of RETREAT (Renal Denervation with Ultrasound After Failed Radiofrequency Denervation) Horst Sievert, Jan Philipp Kulow, Stefan Bertog, Predrag Matić, Sameer Gafoor, Ilona Hofmann, Laura Vaskelyte, Markus Reinartz CardioVascular Center Frankfurt - CVC, Frankfurt, Germany

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