Randall C. Starling, M.D., MPH, FACC,FESCProfessor Of Medicine

Vice Chairman, Cardiovascular MedicineSection of Heart Failure and Cardiac Transplant Medicine

Department of Cardiovascular MedicineKaufman Center for Heart Failure

Heart and Vascular InstituteCleveland Clinic

Cleveland Ohio USA

NOVEL ASSIST DEVICES

Bridge over troubled water: mechanical circulatory support in advanced heart failure

DISCLOSURES

• Thoratec: HeartMate III investigator, scientific advisory committee ROADMAP Trial

• HeartWare: Steering Committee MVAD trial, ENDURANCE Trial investigator

Outline• Covered so far

– Selection– Percutaneous devices– ECMO

• Novel devices– Emerging for mechanical circulatory support– Partial support– Other devices for heart failure

Spectrum of Support

Utilization of Assist Devices

Stretch et al, J Am Coll Cardiol 2014;64:1407–15

Limitations • Patients: Triage and predicting outcomes• Current device limitations adverse events

– High readmission rates• Stroke• Bleeding• Thrombosis• Battery and power• Lack of connectivity and telemetry• Degree of pulsatility

Importance of Triage and Outcomes and Device Selection

Journal of Heart and Lung Transplantation 2013; 32:141-156E Heart Jour 2015;17:501-9.

INTERMACS LEVEL

CARDSHOCK RISK SCORE

Mechanisms of Mechanisms of Action of Action of Cardiac-Support Cardiac-Support DevicesDevices

Baughman et al. N Engl J Med 2007;357:28-38Baughman et al. N Engl J Med 2007;357:28-38

axial

centrifugal

Survival is Excellent with LVAD

ADVERSE EVENTS WITH CF ADVERSE EVENTS WITH CF LVADLVAD

• GI Bleed • Infection • Aortic Insuff• Stroke• Right HF • Hemolysis• Thrombosis • VT

Source: The Journal of Heart and Lung Transplantation 2013; 32:141-156 (DOI:10.1016/j.healun.2012.12.004 )

Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions

Unique Adverse EventsContinuous Flow LVAD

20% at 1 year GI bleedCirc Heart Fail 2011;6:779-84 1/3 at 3 years moderate AI

Circ HF 2014;7(2):310-9.

Design Enhancements: Sintering and Coring Tool

Tissue growth on inflow cannulas of non-sintered (A) and sintered

(B) inflow cannulas

Enhanced Coring Tool

Non-Sintered (A) and Sintered (B) HVAD

A. B.

A. B.

Eccentric PannusEccentric Pannus

Healed ScarHealed Scar Also in early to mid 2011, an enhanced coring tool and sintering on the pump inflow cannula were introduced.

CAUTION: Investigational device. Limited by United States law to investigational use.

HVAD

ApprovedApprovedAxial Flow LVADAxial Flow LVAD

Axialruby bearing

New Technology

MVAD HeartMate III

*B169-0313

HeartMate III*

Hematologically Friendly, Proven Full Magnetically Levitated VADFeatures• Fully Magnetically LevitatedDesigned to be Hematologically compatibleLarge pump gaps leading to reduced blood traumaTextured blood contacting surfaces

Artificial pulseWide range of operationFull support (10L / min)

• Surgically IntelligentAdvanced Implant / Explant – Engineered apical attachment

Modular Driveline

• Pocket Controller

• Target CE Mark Clinical trials initiation mid 2013 and US trial in progress 2015

Program Status

*In development. Not approved for clinical use.

“artificial pulse”

Trial Design All Comers

www.heartware.com

Durable Partial SupportEU and US trials for “less ill”

The CircuLite® Synergy device is implanted via a small right-sided thoracotomy with an inflow cannula in the left atrium and an outflow graft connected to the right subclavian artery without the use of extracorporeal circulation. The micro-pump is the size of an AA battery, sits in the 'pacemaker' pocket subcutaneously in the right clavicular groove and pumps up to 3.0 l min⁻¹ from the left atrium to the right subclavian artery.

Non sternotomy percutaneous option: transeptal inflow cannula

Aortic External Counter-pulsation• NYHA Class III• Pre LVAD• Failed CRT• Optimal

medical • outcomes trial

– HF hosp, LVAD, TX

• Feasibility study 20 ptshttp://counterhf.sunshineheart.com/the-counter-hf-study

https://clinicaltrials.gov/ct2/show/NCT01740596JACCHF 2014;2:526-33.

LV Exclusion Device

• Outcomes trial n=560 NYHA III or early IV

• Primary: death or hosp HF

• Post MI structual remodeling

• Background GDMT

Circ Heart Fail. 2014;7:752-758.)

Left atrial decompression through unidirectional left-to-right interatrial shunt for the treatment of left heart failure: first in man

• Reducing LA pressure by shunted to the RA may relieve symptoms

• flow from the LA to the right atrium if the pressure gradient exceeds 5 mmHg

• Applicable to HF rEF and HF pEF

EuroIntervention. 2015 January ; 10(9): 1127–1131.

Summary• LVADs will evolve and improve

– Totally implanted with power supply– Smaller and lighter– Reduced risk of adverse events– Risk stratification and selective use of

percutaneous devices for recovery or bridging

• LVAD use in less ill patients…eventually

• Improved technology will expand the use of LVAD