Daniel Bensimhon, MD Cone Health

1. Devices in the
Management of
Chronic Heart
Failure
DAN BENSIMHON, MD
MEDICAL DIRECTOR,
AFH/MCS Program
Cone Health
4 May 2024

2. 2
1. Heidenreich PA, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure. Circulation 2022; 2. Vaduganathan M, et al. Estimating lifetime benefits of comprehensive disease-modifying pharmacological therapies in patients with heart failure with reduced ejection fraction: a comparative analysis of three randomised controlled trials. Lancet Vol 396,
Issue 10244, P121-128, July 11, 2020; 3. Rahamim E, et al. Contemporary Pillars of Heart Failure with Reduced Ejection Fraction Medical Therapy. J. Clin. Med. 2021, 10, 4409
GDMT improves HF morbidity and mortality
1.4-6.3years
ARNI
20% decrease in sudden death, 21% decrease
in VA, ICD shock or resuscitated cardiac arrest
in PARADIGM-HF
Β-Blockers
31% decreased in sudden death based on meta-
analysis of trials
MRA
23% decrease in sudden death in RALES,
EPHESUS, EMPHASIS-HF
SGLT2i
21% decrease in VA, resuscitated cardiac arrest
or sudden death in DAPA-HF
Estimated aggregate mortality benefit of
comprehensive quadruple therapy in HFrEF1
2022 AHA/ACC/HFSA HF Guidelines1-3

3. Disclosures
◼ Consulting/speaker/ownership interests: Boehringer-Ingelheim,
Pfizer, Janssen, AstraZeneca, Sensible Medical, Caption Health,
AquaPass, scPharmaceuticals, Adjacent Health, Ventricle Health

4. Residual risk remains despite full GDMT
1. Fatima K Eur Jrnal of (2023) 25, 1477–1480 2. Packer M, Circ: NEJM 2020

5. DEVICES in CHRONIC HF:
ICDs/CRT

6. 2022 HF ICD Guidelines

7. HF 2022 CRT Guidelines

8. DEVICES in CHRONIC HF:
Filling the Gap Between MEDs & VADs

9. DEVICES in CHRONIC HF: Filling the Gap
II III IV
I
NYHA CLASS

10. DEVICES in CHRONIC HF:
BAROSTIM

11. 11
1. Creager MA, Creager SJ. J Am Coll Cardiol. 1994;23(2):401-5
BAROSTIM: Autonomic nervous system as therapeutic target

12. 12
12
*Data from different studies and different patient populations may not be directly comparable
1. Zile MR, et al. J Am Coll Cardiol 2020; 76:1-13. 2. Rector TS, et al. J Card Fail. 1995;1(3):201-216. 3. Higgins SL, et al. J Am Coll Cardiol 2003;42:1454 –1459.
4. Abraham WT, et al. N Engl J Med 2002;346:1845–1853. 5. Gremeaux V, et al. Arch Phys Med Rehabil. 2011;92(4):611-619.
BeAT-HF symptom improvement at 6 months1
52%
29%
13%
2%
0%
10%
20%
30%
40%
50%
60%
70%
Change
in
6
month
NYHA
Class
NYHA class
Barostim Control
Improved
2 NYHA
Classes
34%
Improved
CRT trial results
CONTAK CD3
NYHA III or IV
LVEF ≤ 35%
QRS > 120ms
20%
MIRACLE4
NYHA III
LVEF ≤ 35%
QRS > 130ms
30%
Improved
1 NYHA
Class
34%
Improve
-21
-6
-14
-25
-20
-15
-10
-5
0
Change
in
6
month
MLWHF
Quality of life
(MLWHF)
Clinically
Meaningful2
-5 Points
-14
Points
CRT trial results
CONTAK CD3
NYHA III or IV
LVEF ≤ 35%
QRS > 120ms
-11
MIRACLE4
NYHA III or IV
LVEF ≤ 35%
QRS > 130ms
-9
Barostim Control Diff
49
-8
60
-20
-10
0
10
20
30
40
50
60
70
Change
in
6
month
6MHW
Exercise capacity
(6MHW)
Clinically
Meaningful5
25 Meters
CRT trial results
CONTAK CD3
NYHA III or IV
LVEF ≤ 35%
QRS > 120ms
39
MIRACLE4
NYHA III or IV
LVEF ≤ 35%
QRS > 130ms
29
Barostim Control Diff
+60
Meters

13. 13
1. Zile MR, et al. J Am Coll Cardiol 2020;76:1-13 2 Zile MR, et al. J Am Coll Cardiol. 2016;68:2425-2436.
BeAT-HF Results: NT-proBNP reduction1
-25%
reduction
Clinically
meaningful
10% relative
reduction2
Change
to
6
Month
NT-
proBNP
(%
Change
from
baseline)
10%
5%
0
-
10%
-
15%
-25%
-
30%
-
5%
-
20% -21%
-25% p=0.004
BAT Control Diff
3% Barostim Indication
• NYHA Class III or Class II (who had a recent
h/o Class III) despite treatment with GDMT
• LVEF ≤ 35%
• NT-proBNP <1600 pg/ml.

14. DEVICES in CHRONIC HF:
Cardiac Contractility Modulation (CCM)

15. Cardiac Contractility Modulation (CCM)
There are thought to be two modes of action:
1. Improvement of calcium handling within the myocyte
2. Normalization of abnormal gene expression seen in HF

16. 0.91
9.5
20 67%
1.7
11.4 34
81%
2.32
14.9
57
82%
Peak Vo2 (ml/kg/min) MLWHFQ (points)
Clinically Meaningful @ 5 Points
6MHW (meters)
Clinically Meaningful @ 25M
NYHA (% Improving ≥ 1 Class)
CRT
CCM
CCM (EF 35-45%)
• NYHA Class III
• LVEF 25-45%
16
CRT and CCM Landmark Trials
16
10 For CRT: Higgins JACC 2003, Abraham NEJM 2002, Abraham Circulation 2004, Young JAMA 2003, Cazeau NEJM 2001, Leclercq EHJ 2002
11 For CCM 25-45% - 2020 - Wiegn, et al, Circulation Heart Failure - doi.org/10.1161/CIRCHEARTFAILURE.119.006512
12 For CCM 35-45% - 2018 - Abraham, et al, JACC Heart Failure - doi.org/10.1016/j.jchf.2018.04.010
Note - data weighted by patient numbers and provided only as a comparison
CCM Indication

17. 503 RW Prospective European Registry
17
Kuschyk et al, Eur J Heart Failure 2021 doi:10.1002/ ejhf.2202
Symptomatic systolic heart failure“ (NYHA II-IV, EF < 50%)

18. DEVICES in CHRONIC HF:
Left Atrial Shunts & SDS & AquaPass

19. • Iatrogenic interatrial shunting has demonstrated promise as a treatment
for symptomatic patients via left to right atrial unloading
EXERCISE
8mm diameter
shunt
Interatrial Shunt Size and Left Atrial Decompression:
Therapeutic Rational
SHUNT
NO SHUNT
Kaye et al. J CardFail. 2014

20. Device/
procedure
Corvia V-Wave Occlutech Edwards Alleviant NoYA InterShun
t
Type Implant Implant Implant Implant Procedure Procedure Procedure
Description Nitinol stent Nitinol/PTFE
hourglass
Nitinol braid with
central orifice
Tubular nitinol
device with
retention arms
RF catheter RF catheter Cutting
catheter
Shunt flow LA  RA LA  RA LA  RA LA  CS LA  RA LA  RA LA  RA
Shunt size 8 mm 5.1 mm 4, 6, 8, 10 mm 7 mm 6 mm 4-12 mm 4 mm
*CS = coronary sinus
Atrial shunt devices/procedures

21. Win ratio: 1.0 (95% 0.8-1.2)
Finkelstein-Schoenfeld p-
value=0.85
REDUCE LAP-HF II RCT: Neutral overall
Shah SJ, et al. Lancet 2022
Cumulative
incidence
of
CVD
death
or
CVA
(%)
Cumulative
incidence
of
HF
events
(%)
30
25
20
15
10
5
0
6
5
4
3
2
1
0
0 2 4 6 8 10 12 0 4 8 12 16 20 24
Time since randomization (months)
Time since randomization (months)
Atrial shunt device
Sham procedure
Log-rank P=0.41
Atrial shunt device
Sham procedure
Log-rank P=0.42

22. LVEF >40% (n=302)
Pinteraction<0.0001
RELIEVE-HF: Risk of all CV Events by LVEF
LVEF ≤40% (n=206)
Stone GW, et al. ACC.24 LBCT Abstract Presentation, April 6, 2024
Courtesy: W. Abraham, MD. ACC 2024

23. VisONE Implant System: Synchronized Diaphragmatic Stimulation
Implantable Pulse Generator (IPG)
Active Fixation Leads
Lead Placement Tool
Placement Through Minimal Invasive Laparoscopy

24. Acute SDS Impact on Cardio-Pulmonary Pressures
Porcine model. Achanta S, Fudim M et al., Duke University
SDS On SDS Off
ECG
Intrathoracic Pressure
Pericardial Pressure
2. Post HF initiation +
volume overload
1. Baseline
3. SDS on
for 10 min
⬇ Intrathoracic pressure -> ⬆︎ RA filling
⬇ Intrathoracic pressure -> ⬆︎ PV capacitance -> ⬇ LA volume

25. SDS: RECOVER-HF Pilot
HF Parameter Trends
Non-US Multicenter Study Piloting the
RECOVER-HF: Double Blind RCT
- 2 centers, enroll up to 30pts. EF<40% & QRSd <130ms
- 3 month follow-up
- Interim analysis on subset N=13 (6 control)
- Ages: 62+/- 12y
- LVEF 33 +/- 5%
Courtesy: M. Fudim, MD. THT 2024

26. • Controlled micro-
environment -> stay dry
• Adjunct to diuretics
• Independent of renal
function
• Use 2-3x/week or in ADHF
with diuretic resistance
• Dialysis patients?
AquaPass Technology – Sweating off HF
900 60
800 55 2.4
700
600
500
400
300
200
1
00
0
50
45
40
35
30
25
20
1
5
2.2
2
1
.8
1
.6
1
.4
1
.2
1
EFFECTIVENESS RENAL FUNCTION
Fluid loss & Rate in 3.9hr BUN m g /dL Cr m g /dL
Meaning ful fluid loss
Fluid loss gr Rate gr/hr
M ed ian (all patients)
Baseline En d of Study
M ed ian (all patients)
Baseline End of
M edian (all patients
Preserved renal function
RESULTS ADHF STUDY
193gr/hr

27. AquaPass Technology – Sweating off HF
HF Fluid removal rate vs. Renal Function
CKD IV CKD III CKD II
Initial ADHF study (n=40):
- Nt-ProBNP (↓50%), KCCQ (14 → 61)
- Congestion score (6 → 2), Weight Loss (-4.7Kg)
- 30% reduction in diuretic dose
Interdialytic Pilot data in ESRD
1,2 Aquapass, unpublished data
Interdialytic patients
- Significant decrease in interdialytic weight gain
- Stable electrolytes

28. Questions? And yes, they do grow up