HISTORICAL PERSPECTIVES OF MECHANICAL CARDIAC ASSIST
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1 HISTORICAL PERSPECTIVES OF MECHANICAL CARDIAC ASSIST Rohinton J. Morris, MD Chief- Cardiothoracic Surgery, Abington-Jefferson Health Systems
2 PROGRAM Past From inception to clinical use Present Devices, patients & outcomes Future Technology, management & directions
3 THE BEGINNING
4 EARLY HORIZON OF CARDIAC SURGERY 1949-Bailey, Harken surgically treat mitral stenosis Gibbon introduces the heart-lung machine Late 50 s- multiple tissue substitutes/homografts in desc aorta 1960-Starr s caged ball valve
5 BACKGROUND Kennedy is President, declares that man will land on the moon this decade, and faces nuclear war with the Cuban missile crisis. John Glenn orbits the earth 1 st Kmart is opened Wilt Chamberlain scores a 100 pts in a game 3 Boeing 707 s have fatal crashes The Rolling Stones debut & Marilyn Monroe dies Mariner2 flies by Venus, transmitting 1 st data from another planet. Watson, Crick & Wilkins win the Nobel prize in medicine for the structure of DNA Norman Shumway is transplanting animal hearts
6 EARLY PIONEERS U.S. Artificial Heart Program (LBJ) Drs. DeBakey and Kolff The Heart is a Pump NHI morphs into NHLBI 1967 Barnaard, Shumway leadthe world into heart transplantation
7 HISTORY- MCS/DT VADs began as an additive technology Transplant List Mortality was too high Assist was the key word Whether permanent, mechanical, orthotopic replacement of the heart will be feasible or practical remains a moot question Cooley 2001 Cooley w/liotta heart
8 First Generation Long-term VADs As BTT Thoratec Paracorporeal Thoratec HeartMate XVE WorldHeart Novacor
9 DEATH ON UNOS HEART TRANSPLANT WAITING LIST Year Pts 5,401 5,946 6,286 6,380 6,971 7,165 7,291 7,658 7,540 7,336 Deaths Rate per 100 yrs UNOS 2001 Annual Report And it worked!
10 LVAD SUPPORT TAH SUPPORT From single ventricle support to biventricular support with CardioWest Increase in organ preservation, such as the brain and kidneys Removing the diseased heart NEJM Reported 79% survival compared to 46% in controls
11 CARDIOWEST TAH: HISTORY Evolved from Univ. Utah / Jarvik Developed under CardioWest Technologies Inc : IDE trial 2001: SynCardia founded 2003 : Approved by FDA
12 CARDIOWEST TAH SYSTEM Implantable TAH Drivelines External Console
13 IMPLANTABLE TAH FEATURES Outflow Occupies space of diseased heart Displaces 400 ml Weighs 160 grams Inflow Blood flow path same as normal heart Inflow <2 cm Blood path <20 cm Right Left Adjustable ventricle orientation No surgical pocket required
14 Courtesy of Dr. Arnar Geirrson
15 Courtesy of Dr. Arnar Geirrson
16 Courtesy of Dr. Arnar Geirrson
17 Courtesy of Dr. Arnar Geirrson
18 Courtesy of Dr. Arnar Geirrson
19 Courtesy of Dr. Arnar Geirrson
20 FROM BTT TO DT Can patients survive just on the pump? How long can the pump last? Most importantly : Who is a candidate? and Who is not? Dr. Eric Rose, Columbia leads the first randomized device study 20 OHT centers
21 FIRST DEVICE FOR RANDOMIZED STUDY
22 REMATCH First glimpse into our future Cardiac replacement was the holy grail DT therapy enters the lexicon and demands a greedy algorithm from industry the goal is no longer just txp
23 SLOW ADOPTION OF DT High infection rate Pump breakdown Size issues Power requirement The answer: Continuous flow instead of a pump. -Only one moving, but durable, part -No volume capacitance -Less energy requirement -Smaller w less surgical issues
24 CONTINUOUS FLOW LVAD
25 HEARTMATE VE & HEARTMATE II SIZE COMPARISON Currently in clinical trials in Europe; not available in the U.S.
26 HEARTMATE II LVAS Small, advanced blood pump, designed to improve patient outcomes and quality of life. 60 percent smaller pocket requirement and 44 percent shorter surgical time than older model Electrically powered Batteries and line power Home discharge
27 HEARTMATE II INTERNAL VIEW Outlet Housing Rotor Magnet Rotor Bearings Inlet Stator Outlet Stator Motor Capsule Motor Winding Inlet Housing
28 HEARTMATE II BTT RESULTS
29 AXIAL FLOW PUMP RESULTS Retrospective review 13 pts in pulsatile; 14 pts in non-pulsatile Equally mixed between BTTX and DT Novacor, HeartMate and Jarvik devices AnnThorSurg- 2007
30 NEAR THE PRESENT
31 HISTORICAL CHANGE IN 21 ST CENTURY- W HMII Continuous flow LVADs become the norm for BTT & DT Industry responds, research explodes, registries are formed. Joint Commission earmarks DT for formal review
32 VAD USE IN THE ELDERLY U.S. VAD use has risen steadily over the past decade and is rising exponentially (Courtesy- Thoratec) Although older pts have inferior survival post-vad 6mo), post-txp survival is 5yrs) [Sandner JHLT 2009:28] >65 ISHLT 2009
33 TXP & VAD IN ELDERLY -5 YR. SURVIVAL % ---59% drop Txp Txp >65 Txp 60-65wVAD Txp >65 w VAD [Courtesy ISHLT Registry L. Edwards, Apr, 2009] ISHLT 2009
34 THE NOW
35 VAD CERTIFIED CENTERS DT centers ( date) are CMS approved 15 in state of PA, 10 in state of NY 67 approved in % growth in 6 years.
36 COMPARABLE TECHNOLOGY
37 MEDICAL TECHNOLOGY - ICD Defibrillation known to save lives Implantable pads a surgical procedure Transvenous implantation & efficacy proven Technology that created new patient treatment pathway
38 ICD GROWTH Transformative technology that increased the patients referred for therapy Explosion in cases and in the field of electrophysiology Massive increase in #of centers, fellowship trainees, governmental oversight. A DISRUPTIVE technology that also increased survival!
39 MEDICAL TECHNOLOGY JOINT REPLACEMENT 1891 Gluck Ivory ball prosthesis...led to biocompatible materials...led to (1936) cobaltchrom alloys...led to (1981) Charnley Teflon socket... Industry explosion, massive manpower increases, research for better prostheses Consumer Reports - >600,000 patients yearly!!!
40 DISRUPTIVE TECHNOLOGY- CLAY CHRISTENSEN (HBR)
41 IF YOU DON T BELIEVE LISTEN TO CAPTAIN KIRK I m telling you, Spock, this VAD thing is the Real Deal!
42 FROM BTT TO DT
43
44 HEARTMATE DT SURVIVAL BENEFIT VS MEDICAL MANAGEMENT Two-Year Outcomes in the Destination Therapy Post-FDA-Approval Study with a Continuous Flow Left Ventricular Assist Device: A Prospective Study Using the INTERMACS Registry. U.P. Jorde, S.S. Khushwaha, A.J. Tatooles, et al. Presented at the ISHLT annual meeting, April 25, 2013.
45 IMPROVED SURVIVAL IN LVAD TRIALS Percent Survival Months HM II BTT Starling JACC 2011 HM II BTT Pagani JACC 2009 HM II BTT Miller NEJM 2007 HM II DT Slaughter NEJM 2009 VE DT LVAD REMATCH Rose NEJM 2001 XVE DT LVAD Slaughter NEJM 2009 Novacor DT LVAD INTrEPID Rogers JACC 2007 OMM REMATCH Rose NEJM 2001 OMM INTrEPID Rogers JACC 2007
46 PATIENT SELECTION DT risk score estimate of 90-day hospital mort (Lietz, Miller- SemThCVSurg) Limits older pts, exclud mech vent, iabp, small size, clin severity of HF Other models available
47 INTO THE FUTURE
48 TO BOLDLY GO WHERE NO MAN HAS GONE BEFORE...
49 PROJECTIONS-U.S. POPULATION: AGE % 6.8% 7.6% 11.3% > Totals
50 WHY SHOULD LVAD MANAGEMENT BE PERFORMED IN THE COMMUNITY 1. Better appreciation of the natural history of heart failure will improve outcomes clinically Treatment options offered to local patients Utilization of resources efficiently Earlier recognition of advanced heart failure 134HTx centers
51 GLOBAL EXPANSION OF HEARTMATE II 372 HMII centers in 47 countries HeartMate II Locations Geography Centers Americas 188 EMEA 149 APAC 35 *As of April 2014
52 THE COMING ASSIST OF THE FUTURE HeartMate III with Full MagLev
53 HEARTMATE III*: FULL MAGLEV TECHNOLOGY Key Design Feature: Fluid Dynamics (Designed to Minimize Shear Stress and Activation of Blood Components) The HeartMate III rotor and volute have been designed to minimize shear and avoid stasis over the entire range of operation (2 to 10 L/min). 10L/Min Wide Range of Operation 2L/Min
54 THE LOOK OF THE FUTURE Courtesy: The Crux (Discover magazine)
55 STILL REMAINS THE #1 PROBLEM
56 MI TISSUE ENGINEERING (JACC, CHRISTMAN, LEE)
57 CONCLUSIONS Destination Therapy is additive and disruptive Unknown long-term benefit, but more to come with other therapies Technically complicated and complex psychosocially and ethically We re still at the horizon.
58 IN SCIENCE, THE CREDIT GOES TO THE MAN WHO CONVINCES THE WORLD, NOT TO THE MAN TO WHOM THE IDEA FIRST OCCURS. FRANCIS DARWIN Thank you. Dr. Rohinton Morris QUESTIONS
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