New ventricular assist devices. FW Mohr Clinical seminar: Devices for severe heart failure ESC congress Stockholm 2010
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1 New ventricular assist devices FW Mohr Clinical seminar: Devices for severe heart failure ESC congress Stockholm 2010
2 The real world of CHF Prevalence 1-3% in europe, in the age of years up to 10-20% Incidence rate 1 case / 1000 per year About 2% of adult population have CHF Approximately 10 million people in europe Ration man to women 1.5:1 CHF has significant economic impact on health care ESC Guidlines 2008 ESC Stockholm 2010
3 Organ shortage A Global Problem! VAD Therapy - Alternative to HTx? Status quo ESC Stockholm 2010
4 VAD + TAH History 1957:PVC 1969: full metal 1969: Diaphragma 4-chamber heart 1969: first implant TAH
5 Mechanical Assist Indication Kardiogenic shock post AMI Postoperative Low Output Syndrome bridge to transplant destination therapy
6 Definition brigde to bridge bridge to transplant bridge to recovery post-cardiotomy Myocarditis destination therapy BTB BTT BTR ATT
7 Definition II Assist system VAD <-> Left/right <-> bi ventricular intracoroporal <-> paracorporal TAH total implantable <-> percutaneously driven pulsatile <-> continous flow Pneumatic <> electrical driven
8 LVAD versus TAH LVAD TAH
9 LionHeart total implantierbares LVAD
10 CardioWest TAH
11 Ventricular Assist and TAH F.W.Mohr
12 Pulsatile Kardiale Assist-Systeme parakorporale VAD Excor Primary indication bridge to HTx and post cardiotomy LCOS univentricular and biventricular For adults + children Pneumatically driven high mobility Anticoagulation cumadin+aspirin Weaning possible
13 Fibrin layers >> Exchange
14 Excor LVAD u. BIVAD complications Thrombo embolic: splen,cerebral (8 / 48 ) Bleeding: Re thoracotomies (13 / 48) cerebral hemorrhage (6 / 48) retroperitoneal Hämatoma(5 / 48)
15 TCI Heartmate
16 Rematch Trial 129 pts. (68 LVAD / 61 medical therapy) Enrollment May 1998 July 2001 NYHA 4 / all pts. non eligible for HTx
17 REMATCH-Studie (enrollment ) 100 survival (%) Med n = 61 LVAD n = 68 HTx Timinterval post implant (Months) Rose et al. NEJM 2001
18 Current trends of treatment of CHF Mortality,Morbidity, Prevention, and QoL Pharmacological treatment Physical training and non-medical management Device therapy ICD and CRT Surgical options Revascularization Surgical ventricular restoration Surgical / interventional MV-Repair Transplantation VAD TAH ESC Stockholm 2010
19 Patient selection - Achilles`heel ESC Stockholm 2010
20 Device selection - the way to go Support as LVAD / RVAD or BiVAD Partial support or TAH Intra- or extracorporeal implantation Pulsatile or non-pulsatile device Current trend, pulsatile VADs are being displaced by axial or centrifugal pumps LVAD / RVAD BiVAD TAH HM II TCI HVAD Excor IVAD TAH CardioWest AbioCor AbioCor II Carmat Reinheart ESC Stockholm 2010
21 INCOR in situ
22 New generation of ventricular Axial flow pump: HM II / Thoratec for LVAD assist device I ESC Stockholm 2010
23 Clinical scenario A 52-year old man, ICM, ventricular arrhythmia, NYHA 4 ESC Stockholm 2010
24 Clinical scenario OR: LV reconstruction / modified DOR + LVAD (HMII) Currently, the patient is 364 days on pump, feeling well without any problems, NYHA II, and with good QoL ESC Stockholm 2010
25 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 ESC Stockholm 2010
26 Clinical scenario HeartWare HVAD as LVAD, RVAD and full implantable biventricular assist CRT 3: HVAD as RVAD and 4: HVAD as LVAD not seen HVAD as LVAD: Mohr et al HVAD HVAD as BiVAD: Hetzer R et al HVAD as BiVAD: Strueber et al ESC Stockholm 2010
27 New generation of LVAD Outcome Survival 1y 48% Survival 2y 17% Rose et al. REMATCH NEJM 2001 Survival 1y 70% Survival 2y 60% Slaughter et al. NEJM 2010 ESC Stockholm 2010
28 New generation of LVAD Outcome HeartWare HVAD: Data from europe, Kaplan-Meier Survival Curve (n = 100) 90% 86% 78% Survival 0.5y 90% 180 days Survival 1y 86% Strueber, et al. ISHLT Annual Meeting 2010 ESC Stockholm 2010
29 Health Status / Prognosis Partial ventricular support New philosophy and indications Current therapy limitations Wide QRS (~30%) CRT VAD Highly Invasive Big Gap due to Normal QRS - Not sick enough for LVAD ICDs NYHA II NYHA III NYHA IV CGS Disease Severity ESC Stockholm 2010
30 Partial ventricular support Patient Design Procedure CircuLite Class IIIb and early Class IV Cardiac Output: 2-3L/minute Ambulatory, home-bound Partial Support, 2-3L/minute Supplements native function Superficial procedure Off-pump mini-thoracotomy Current VADs Late Class IV and Shock Cardiac Output: 1-2L/minute Hospitalized, bed-bound Full Support, 5-6L/minute Replaces native function Urgent, open heart procedure Sternotomy and bypass ESC Stockholm 2010
31 Partial ventricular support 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 Meyns et al. Proofe of concept JACC 2009 ESC Stockholm 2010
32 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) ESC Stockholm 2010
33 Surgical Implant Improvement Technology / HM II Graft Tunneling Final Connection & De-air Pump Aortic Anastomosis Apical Connection Project Objectives Improve the HeartMate implant procedure to reduce surgical time, recovery time and adverse events (e.g., bleeding) Develop a set of tools and methods to enable a less invasive and safe off-pump placement Apical Attachment Device Develop a rapidly-deployable and durable left ventricular attachment mechanism With permission of Thoratec ESC Stockholm 2010
34 New pumps / HeartMate III 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 ESC Stockholm 2010
35 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 ESC Stockholm 2010
36 Force (lb) Infection Reduction Technology Project Objectives Develop stabilization and exit site improvement technologies to significantly reduce percutaneous lead (driveline) infection Maximum Force at Cutaneous Tissue Separation Pursuing device-based internal mechanical stability anchoring technologies Focus on trauma-induced lateonset infection Advanced exit site material morphology and chemistry for improved tissue / percutaneous lead interface 0 Control Test With permission of Thoratec ESC Stockholm 2010
37 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 ESC Stockholm 2010
38 Endovascular VAD Implantation 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. With 38 permission of CircuLite ESC Stockholm 2010
39 Upcoming Challenge of VAD The real clinical scenario Device selection, indication and outcome Increasing numbers of pts. suffering from CHF Type of VAD, LVAD or BiVAD, TAH Deficit or marginal donor hearts Bridging or destination Screening, Evaluation and decision-making Technology therapy and Product developemt should be done In by a hospital Heart Failure care, Team (HFT) Miniaturization teams, coordinator / MiniVADs and easy connectors Time point of implantation Patient QoL not to late! Durability and reliability Infrastructure, Solutions Home Care, for Hard-Ware Telemonitoring problems Prospective Platforms Trials and Registries for out-hospital monitoring Costs ESC Stockholm 2010
40 Database Home Statute Members Executive Board Forms Important Dates Contact Founded on December 10, 2009 in Berlin EUROMACS unites individuals and institutions with the goal of running a European registry for data from patients with mechanical circulatory support systems. The data collected will then be made available for research purposes. Further, the registry will allow comparison between European and international data in the field of mechanical circulatory support, e.g. with data from the American INTERMACS registry. Euromacs will publish annual reports on the development of ventricular assist device therapy in Europe. ESC Stockholm 2010
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