A rapid overview of indications to Mechanical Circulatory Support in the Acute and Chronic Setting of Heart Failure concluding with the new horizons in LVAD therapy and Heart Replacement.

1. Dr. Rita Gravino
UOSD Cardiologia Riabilitativa Intensiva e Scompenso
Università degli Studi di Napoli “Luigi Vanvitelli”
AORN dei Colli
Ospedale Monaldi, Napoli
Dr. Cristiano Amarelli
UOSD Trapianti di cuore e assistenza meccanica di circolo
UOC Cardiochirurgia
Università degli Studi di Napoli “Luigi Vanvitelli”
AORN dei Colli
Ospedale Monaldi, Napoli
New
ventricular
assist
devices
Napoli, venerdì 6 Ottobre 2017

2. VENTRICULAR ASSIST DEVICES
• Initially developed to address short
term needs in patients who struggled
coming off pump during cardiac surgery
• With new technology, subsequently used
when needed to provide hemodynamic
support for those patients who were
clinically declining while awaiting
transplant

3. 1957:PVC 1969: full metal 1969: Diaphragma
4-chamber heart 1969: first implant TAH

5. 5
VENTRICULAR ASSIST DEVICES
• Bridge to recovery
– explant once clinically stabilized with expectation
of acceptable native cardiac function (post MI)
• Bridge to transplant
– unable to wait until an organ is available
• Bridge to decision
– options unclear
• Destination Therapy
– non-transplant candidate

6. Acute
Setting
ESC 2016

7. Short term assist device

8. Short term assist device

9. Short term assist device

12. Short term assist device

13. Chronic
Setting
ESC 2016

14. Selection Criteria
• Inability to walk a block without shortness of breath
• Intolerant or refractory to ACE inhibitors, ARBs, B-
blockers
• 1 HF–related admission in the past 6 months
• CRT nonresponder
• High diuretic dose (e.g., 120 mg/d furosemide)
• Serum sodium < 136 mmol/L
• BUN > 40 mg/dL
• Hematocrit < 35%
Thoratec

15. Issues to Assess Pre-operatively
• RV function – there is no DT RVAD
• Aortic insufficiency – may require AVR
• Anticoagulation - contraindications
• Insight/compliance – not a “quick fix”
• Family/social support – a total buy-in
• Financial – will Heathcare system cover it?
1
5

16. When Should You Refer?
• Medication intolerance
• Repeat hospitalizations
• Can’t “bounce back”
• Failure to thrive
1
6

17. Patient selection - Achilles`heel
Before they get too sick

19. Partial replacement of
ventricular function
(Booster pumps)
VADs
Pulsatile
VENTRICULAR ASSIST DEVICES
Pumps that emulate
the natural heart.
Continuous
Pumps with no direct
resemblance to natural
heart
Bulky valved devices
Blood pressure variations and pulse still
present
Smaller valveless devices
No palpable pulse; BP detectable
by Doppler

20. Generation
Long-Term
Use
Short-
Term
Use
Valves
Pulsatile 1 HeartMate XVE Valved
Continuous
2
(Coaxial)
HeartMate II Impella
Valveless
3
(Centrifugal)
HeartWare
HeartMate 3
CentriMag
Ventricular Assist Devices

21. New generation of ventricular
assist device I
Axial flow pump: HM II / Thoratec for LVAD

22. New generation of ventricular
assist device II
HVAD® Miniaturized Pump / HeartWare for LVAD / RVAD / BiVAD
Simplified Surgical Procedure
• Implanted in the pericardial
space
• Via median sternotomy or left
thoracotomy
• No surgical pump pocket
Advanced Design
• Centrifugal flow Hydromagnetic
suspension
• Wear-less, wide channel
impeller design
• Design optimizes flow, pump
surface washing, and
hemocompatibility

23. New generation of LVAD
Outcome
Survival 1y 48%
Survival 2y 17%
Survival 1y 70%
Survival 2y 60%
Rose et al. REMATCH
NEJM 2001
Slaughter et al. NEJM 2010

24. New generation of LVAD
Outcome
90%
86%
78%
180
days
Strueber, et al. ISHLT Annual Meeting2010
Survival 0.5y 90%
Survival 1y 86%
HeartWare HVAD: Data from europe, Kaplan-Meier Survival
Curve (n = 100)

25. INTERMACS 2: Which are the possible
solutions?

26. 0
1
2
3
4
5
6
7
8
2010 2011 2012 2013 2014 2015 2016 2017
NUMERO IMPIANTI/ANNO
HM2 HVAD TAH

27. • 11 TAH (età media 61,4)
• Intermacs 1=7, 2=1, 3=1
• 3 ECMO – 1 IABP
• 10 BTC; 2 DT (?)
• 4 Dimessi (498 d)
• 2 Emorragie Cerebrali
• 0 Ongoing
• 3 Trapianti (2 Ongoing)
• 13 HVAD (età media 61)
• Intermacs 2-4
• 6 BTT, 3 BTC, 4 DT (età 73)
• 10 Dimessi (survival condizionale
527 d)
• 4 Trapianti (1 Ongoing)
• 1 Trombosi (DT)
• 3 RVF
• 3 Ongoing (1 BTT, 2 DT)
• 1 Figlio Concepito durante
supporto ;-)

29. Limits of Actual Devices

32. Jarvik 2000 LVAD
➢ Axial-flow (non-pulsatile)
pump
● electric, intra-ventricular
● left heart support only
➢ Speed: 8000-12000 rpm
● flow: ~3-5 lpm
➢ Medium- to long-term therapy
(months to years)
● bridge to transplant
(investigational)

33. Energy sources

34. Fully-Implantable LVAS (FILVAS)
Project Objectives
• Develop a left ventricular assist
system incorporating an
implantable battery and control
system enabling patients to have
some duration of “un-tethered
time” without external
components.
• Mitigate the need for a standard
percutaneous lead, reducing
the incidence of infection.
• Minimize the need for external
components, reducing the
burden for patients and
enhancing quality of life.
Conventional FILVAS Alternative FILVAS
With permission of Thoratec

35. Fully Implantable System
Free
Mobile
Tethered
• Based on Transcutaneous Energy Transfer (“TET”) technology
• Periodically recharged using inductive coupling across the skin
• Fully implantable controller & battery optimized for long term
support and patient mobility
• Wireless monitoring and management of VAD parameters
• Designed for both HVAD® Pump and MVAD® Pump
• No exit site care or risk of trauma to exit site
• Patient physical freedom from external components
• Discreet physical appearance
Advanced Technology
Patient Benefits
Caution: In development and not available for clinical use.

36. Project Objectives
• Develop a full-support, blood pump with full
magnetic rotor levitation and wide gaps for
optimized blood flow
– Reduced adverse event profile
• Incorporate textured surfaces
– Potential for reduced or no anticoagulation
• Capable of producing an artificial pulse
– Physiologic blood flow with potential to
help address late bleeding
• Operate at lower power consumption, allowing
miniaturization of external components
– Optimizes patient quality of life
• Leverage all product development initiatives from
HeartMate II
With permission of Thoratec
Better Haemocompatibility / HeartMate III

37. Strictly Confidential – the contents of this document are the intellectual property of Calon Cardio-Technology Ltd and must not be communicated to any third parties without the written consent of Calon Cardio-Technology Ltd
The MiniVAD pump is uniquely positioned to deliver

38. Strictly Confidential – the contents of this document are the intellectual property of Calon Cardio-Technology Ltd and must not be communicated to any third parties without the written consent of Calon Cardio-Technology Ltd
Introducing the MiniVAD System

39. Partial ventricular support New philosophy and indications
HealthStatus/
Prognosis
Disease Severity
VADCRT
CGSNYHAIII NYHAIV
Wide
QRS
(~30%)
Highly
Invasive
Current therapy limitations
Big Gap due to
No-rmal QRS
Not sick enough
for LVAD
NYHAII
ICDs

40. CircuLite Current VADs
Patient • Class IIIb and early Class IV
• Cardiac Output: 2-3L/minute
• Ambulatory, home-bound
• Late Class IV and Shock
• Cardiac Output: 1-2L/minute
• Hospitalized, bed-bound
Design • Partial Support, 2-3L/minute
• Supplements native function
• Full Support, 5-6L/minute
• Replaces native function
Procedure • Superficial procedure
• Off-pump mini-thoracotomy
• Urgent, open heart procedure
• Sternotomy and bypass
Partial ventricular
support

41. Partial ventricular support
Meyns et al. Proofe of concept … JACC 2009
Synergy Pocket Micro-pump
• Partial support / 3l/min.
• Study in 17 CHF patients.
• Duration of support median 213 days
Improvement of Hemodynamics and
CI
Safe and durable

42. CircuLite® Surgical System
• Pump in subcutaneous
pacemaker pocket
• Right sided mini-
thoracotomy
• Extubation in OR possible
• Off-pump implant procedure
CAUTION: Investigational Device. Limited by United States law to investigational use. Not available for sale.
Designed to assist the less sick patient

43. Endovascular VAD Implantation
With permission of CircuLite
Project Objectives
• Inflow cannula transeptally
deployed in left atrium, via the
subclavian vein and right
atrium.
• Outflow graft attached to the
subclavian artery.
• Pre-clinical evaluation
underway.

44. A next-generation platform designed to enable:
• Support for a wider range of patients
• Left and right ventricular support (LVAD, RVAD)
• Partial and full flow (turn-down capability)
• Less invasive implant technique
MVAD® Pump Platform
CAUTION: Investigational Device. Limited by United States law to investigational use.
Advanced Technology
• MVAD® Pump is approximately half the size of HVAD® Pump
• Similar hydrodynamic and magnetic impeller technology to
HVAD® Pump
• Impeller design optimized to minimize shear stresses
• Thin (3.5 mm diameter), modular driveline
• Gimbaled Sewing Ring to allow for inflow depth adjustments
Potential Benefits

45. Miniaturized VAD Design / MVAD
Goal : Decrease invasiveness & morbidity without decreasing efficacy
Project Objectives
• Three MVADS designs all showing strong
results in preclinical studies.
• Wide bladed, axial flow technology allows
significant miniaturization.
• Partial or full support attainable in all
designs.
• All versions can eliminate full sternotomy.
• Wear-less impeller suspension.
• Versatile, configurable and scalable.
With permission of HeartWare

46. HeartMate X
Dramatically Downsized Chronic Device
(Technology Development)
•Versatile platform, capable of providing partial and
full support (1-8 L/min)
•Leverages core HeartMate II technology
•Dramatic size reduction
− Rapid, less invasive implant
− Versatile cannulation options
•Meets needs of expanded patient pool
− Earlier-stage patients
− RVAD / BiVAD population
•Low power consumption
− Potential for smaller external batteries and
components

47. • Eliminate CPB
• Reduce LOS
• Reduce blood utilization
• Expand treatment population
Transapical® Pump Platform
CAUTION: Investigational Device. Limited by United States law to investigational use.
Advanced Technology
• Intracardiac device with no arterial anastomosis required
• Outflow cannula across aortic valve
• Designed for: Small, single incision, minimally invasive
implant (similar to Transapical TAVR)
• Off-pump implant procedure
Potential Benefits

48. We Continue to Innovate for Providers & Patients
MVAD® Pump SYNERGY®
TET
Transapical
CAUTION: Investigational Device. Limited by United States law to investigational use.
CAUTION: In development and not available for clinical use.
CAUTION: In development and not available for clinical use.

49. Percutaneous Heart Pump (PHP)
Catheter-based
axial flow pump
(Finalizing Design)
•Designed to deliver over 4L of flow under
normal physiologic conditions
•Percutaneous placement through 11F sheath
•Collapsible elastomeric impeller and nitinol
cannula; expands to ~24F
• Unstable AMI
• High-risk PCI
• Acutely decompensated heart
failure
• Potentially other patient
populations
Targeted Applications

50. Endovascular VAD Implantation

51. Total
Artificial
Hearts

52. Trends and perspectives
•Focus and aims of development
– Incidence of AEs and SAEs
– System durability and reliability
– Patient QoL
– Surgical procedure
•Miniaturization of internal and external components
– Potential for “less invasive insertion, connector systems
– Avoid sternotomy
– Less surgical trauma, CPB time and bleeding, hospital stay
•Partial or full support / Potential for LV and RV support
•Full implantable FILVADs
•Transcutaneous energy transfer (TET)