The future of adult cardiac assist devices: novel systems and mechanical circulatory support strategies.

The recent, widespread success of mechanical circulatory support has prompted the development of numerous implantable devices to treat advanced heart failure. It is important to raise awareness of novel device systems, the mechanisms by which they function, and implications for patient management. This article discusses devices that are being developed or are in clinical trials. Devices are categorized as standard full support, less-invasive full support, partial support: rotary pumps, partial support: counterpulsation devices, right ventricular assist device, and total artificial heart. Implantation strategy, mechanism of action, durability, efficacy, hemocompatibility, and human factors are considered. The feasibility of novel strategies for unloading the failing heart is examined.

[1]  R. Dowling,et al.  Acute Hemodynamic Efficacy of a 32-ml Subcutaneous Counterpulsation Device in a Calf Model of Diminished Cardiac Function , 2008, ASAIO journal.

[2]  A. Rahmel,et al.  The Registry of the International Society for Heart and Lung Transplantation: twenty-seventh official adult heart transplant report--2010. , 2010, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[3]  Bart Meyns,et al.  Hemodynamic effects of partial ventricular support in chronic heart failure: results of simulation validated with in vivo data. , 2007, The Journal of thoracic and cardiovascular surgery.

[4]  D. Burkhoff,et al.  Partial mechanical long-term support with the CircuLite Synergy pump as bridge-to-transplant in congestive heart failure. , 2010, The Thoracic and cardiovascular surgeon.

[5]  W. Cohn,et al.  Continuous-flow total artificial heart supports long-term survival of a calf. , 2009, Texas Heart Institute journal.

[6]  S. Spiliopoulos,et al.  New experience with the paracardial right ventricular axial flow micropump impella elect 600. , 2003, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[7]  M. Pasque,et al.  Mechanical support for isolated right ventricular failure in patients after cardiotomy. , 2004, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[8]  BARTLEY P. GRIFFITH,et al.  The Cool Seal System: A Practical Solution to the Shaft Seal Problem and Heat Related Complications With Implantable Rotary Blood Pumps , 1997, ASAIO journal.

[9]  Mark S Slaughter,et al.  Transcutaneous Energy Transmission for Mechanical Circulatory Support Systems: History, Current Status, and Future Prospects , 2010, Journal of cardiac surgery.

[10]  G. Giridharan,et al.  Predicted Hemodynamic Benefits Of Counterpulsation Therapy Using A Superficial Surgical Approach , 2006, ASAIO journal.

[11]  D. Pennington,et al.  Cardiac assist devices. , 1998, The Surgical clinics of North America.

[12]  J. Maessen,et al.  Efficacy of a new intraaortic propeller pump vs the intraaortic balloon pump: an animal study. , 2003, Chest.

[13]  T. Kaul,et al.  Postoperative acute refractory right ventricular failure: incidence, pathogenesis, management and prognosis. , 2000, Cardiovascular surgery.

[14]  T. Myers,et al.  Left ventricular assist system as a bridge to myocardial recovery. , 1999, The Annals of thoracic surgery.

[15]  Roland Hetzer,et al.  Initial experience with miniature axial flow ventricular assist devices for postcardiotomy heart failure. , 2004, The Annals of thoracic surgery.

[16]  T. Athanasiou,et al.  Recent advances in minimal-access cardiac surgery using robotic-enhanced surgical systems , 2004, Expert review of cardiovascular therapy.

[17]  Kevin Bourque,et al.  In vivo assessment of a rotary left ventricular assist device-induced artificial pulse in the proximal and distal aorta. , 2006, Artificial organs.

[18]  Daniel Tamez,et al.  HeartWare miniature axial-flow ventricular assist device: design and initial feasibility test. , 2009, Texas Heart Institute journal.

[19]  J. Entwistle Short- and long-term mechanical ventricular assistance towards myocardial recovery. , 2004, The Surgical clinics of North America.

[20]  P. McCarthy,et al.  Understanding the C-Pulse Device and Its Potential to Treat Heart Failure , 2010, Current heart failure reports.

[21]  R. Hetzer,et al.  Experience with over 1000 Implanted Ventricular Assist Devices , 2008, Journal of cardiac surgery.

[22]  O. Frazier Implantation of the Jarvik 2000 left ventricular assist device without the use of cardiopulmonary bypass. , 2003, The Annals of thoracic surgery.

[23]  A. Montalto,et al.  HeartWare third-generation implantable continuous flow pump as biventricular support: mid-term follow-up. , 2011, Interactive cardiovascular and thoracic surgery.

[24]  C. Garrard,et al.  Implications for the vascular surgeon with prolonged (3 to 89 days) intraaortic balloon pump counterpulsation. , 1997, Journal of Vascular Surgery.

[25]  Axel Haverich,et al.  Successful use of the HeartWare HVAD rotary blood pump for biventricular support. , 2010, The Journal of thoracic and cardiovascular surgery.

[26]  A. Rose,et al.  Pathology in patients with ventricular assist devices: a study of 21 autopsies, 24 ventricular apical core biopsies and 24 explanted hearts. , 2005, Cardiovascular pathology : the official journal of the Society for Cardiovascular Pathology.

[27]  A. Montalto,et al.  Biventricular support with the HeartWare implantable continuous flow pump: an additional contribution. , 2010, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[28]  Daniel Burkhoff,et al.  LVAD-induced reverse remodeling: basic and clinical implications for myocardial recovery. , 2006, Journal of cardiac failure.

[29]  D. Mann,et al.  NHLBI's program for VAD therapy for moderately advanced heart failure: the REVIVE-IT pilot trial. , 2010, Journal of cardiac failure.

[30]  R. Dowling,et al.  Development and Early Testing of a Simple Subcutaneous Counterpulsation Device , 2006, ASAIO journal.

[31]  Helmut Reul,et al.  In vivo experimental testing of a microaxial blood pump for right ventricular support. , 2006, Artificial organs.

[32]  Filip Rega,et al.  Clinical benefits of partial circulatory support in New York Heart Association Class IIIB and Early Class IV patients. , 2011, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[33]  George M Pantalos,et al.  Intraoperative evaluation of the HeartMate II flow estimator. , 2009, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[34]  G. Giridharan,et al.  Hemodynamic and Left Ventricular Pressure-Volume Responses to Counterpulsation in Mock Circulation and Acute Large Animal Models , 2004, The 26th Annual International Conference of the IEEE Engineering in Medicine and Biology Society.

[35]  K. Fukamachi,et al.  Chronic evaluation of the Cleveland Clinic CorAide left ventricular assist system in calves. , 2002, Artificial organs.

[36]  Christoph Benk,et al.  Non-surgical bleeding in patients with ventricular assist devices could be explained by acquired von Willebrand disease. , 2008, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[37]  R. Dowling,et al.  Total artificial heart: destination therapy. , 2003, Cardiology clinics.

[38]  D. Burkhoff,et al.  Mechanical unloading during left ventricular assist device support increases left ventricular collagen cross-linking and myocardial stiffness. , 2005, Circulation.

[39]  Mitsuo Umezu,et al.  In vivo evaluation of a MPC polymer coated continuous flow left ventricular assist system. , 2003, Artificial organs.

[40]  B. Reitz Mechanical devices and US Food and Drug Administration (FDA) approval. , 2006, Seminars in thoracic and cardiovascular surgery. Pediatric cardiac surgery annual.

[41]  Öyvind Reitan,et al.  Hemodynamic Effects of a New Percutaneous Circulatory Support Device in a Left Ventricular Failure Model , 2003, ASAIO journal.

[42]  G. Stein,et al.  Properties of blood‐contacting surfaces of clinically implanted cardiac assist devices: Gene expression, matrix composition, and ultrastructural characterization of cellular linings , 1995, Journal of cellular biochemistry.

[43]  Christoph Benk,et al.  The new Impella intracardiac microaxial pump for treatment of right heart failure after orthotopic heart transplantation , 2001 .

[44]  S. Russell,et al.  Advanced heart failure treated with continuous-flow left ventricular assist device. , 2009, The New England journal of medicine.

[45]  Hiroshi Sugiki,et al.  Temporary Right Ventricular Support with Impella Recover RD Axial Flow Pump , 2009, Asian cardiovascular & thoracic annals.

[46]  A. Cheung,et al.  Comparative outcomes in cardiogenic shock patients managed with Impella microaxial pump or extracorporeal life support. , 2011, The Journal of thoracic and cardiovascular surgery.

[47]  Yoshifumi Naka,et al.  Effects of left ventricular assist device therapy on ventricular arrhythmias. , 2005, Journal of the American College of Cardiology.

[48]  Kiyotaka Fukamachi,et al.  New technologies for mechanical circulatory support: current status and future prospects of CorAide and MagScrew technologies , 2004, Journal of artificial organs : the official journal of the Japanese Society for Artificial Organs.

[49]  L. Hillis,et al.  Intra-aortic balloon counterpulsation. , 2006, The American journal of cardiology.

[50]  K. Fukamachi,et al.  Development of the DexAide Right Ventricular Assist Device Inflow Cannula , 2008, ASAIO journal.

[51]  T. Myers,et al.  Biventricular assistance with the Jarvik FlowMaker: a case report. , 2004, The Journal of thoracic and cardiovascular surgery.

[52]  K. Fukamachi,et al.  Introduction of fixed-flow mode in the DexAide right ventricular assist device. , 2010, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[53]  M. Slaughter,et al.  Hemodynamic Responses to Continuous versus Pulsatile Mechanical Unloading of the Failing Left Ventricle , 2010, ASAIO journal.

[54]  A. Merry,et al.  Chronic extra-aortic balloon counterpulsation: first-in-human pilot study in end-stage heart failure. , 2010, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[55]  T. Akutsu,et al.  Cardiac disuse atrophy during LVAD pumping. , 1988, ASAIO transactions.

[56]  Victor L Poirier,et al.  Design Features, Developmental Status, and Experimental Results With the Heartmate III Centrifugal Left Ventricular Assist System With a Magnetically Levitated Rotor , 2007, ASAIO journal.

[57]  R. Autschbach,et al.  Treatment of Right Heart Failure with a New Microaxial Blood Pump , 2006, Asian cardiovascular & thoracic annals.

[58]  T. Mihaljevic,et al.  Human clinical fitting study of the DexAide right ventricular assist device. , 2009, Artificial organs.

[59]  Marvin J Slepian,et al.  Cardiac replacement with a total artificial heart as a bridge to transplantation. , 2004, The New England journal of medicine.

[60]  W. Keon,et al.  Patient selection for left ventricular assist devices. , 2004, Artificial organs.

[61]  D. Farrar,et al.  A versatile intracorporeal ventricular assist device based on the thoratec VAD system. , 2001, The Annals of thoracic surgery.

[62]  B. Griffith,et al.  Proof of concept: hemodynamic response to long-term partial ventricular support with the synergy pocket micro-pump. , 2009, Journal of the American College of Cardiology.

[63]  Harvey S Borovetz,et al.  The National Heart, Lung, and Blood Institute Pediatric Circulatory Support Program. , 2005, Circulation.

[64]  H. Schima,et al.  Suction events during left ventricular support and ventricular arrhythmias. , 2007, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[65]  V. Jeevanandam,et al.  Circulatory Assistance With a Permanent Implantable IABP: Initial Human Experience , 2002, Circulation.

[66]  K. Fukamachi,et al.  In vivo evaluation of zirconia ceramic in the DexAide right ventricular assist device journal bearing. , 2010, Artificial organs.

[67]  R. Autschbach,et al.  A new right ventricular assist device for right ventricular support. , 2003, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[68]  Y. Taenaka,et al.  Influence of prolonged ventricular assistance on myocardial histopathology in intact heart. , 1996, The Annals of thoracic surgery.

[69]  Mitsuo Umezu,et al.  EVAHEART: an implantable centrifugal blood pump for long-term circulatory support. , 2002, The Japanese journal of thoracic and cardiovascular surgery : official publication of the Japanese Association for Thoracic Surgery = Nihon Kyobu Geka Gakkai zasshi.

[70]  G. White,et al.  Extra-ascending aortic versus intra-descending aortic balloon counterpulsation-effect on coronary artery blood flow. , 2005, Heart, lung & circulation.

[71]  Magdi H Yacoub,et al.  The role of bridge to transplantation: should LVAD patients be transplanted? , 2004, Current opinion in cardiology.

[72]  William E Cohn,et al.  Total Heart Replacement Using Dual Intracorporeal Continuous-Flow Pumps in a Chronic Bovine Model: A Feasibility Study , 2006, ASAIO journal.

[73]  M. Rothman,et al.  A first‐in‐man study of the reitan catheter pump for circulatory support in patients undergoing high‐risk percutaneous coronary intervention , 2009, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[74]  K. Kamohara,et al.  Cadaver fitting study of the DexAide right ventricular assist device. , 2007, Artificial organs.

[75]  D. T. George,et al.  Aortomyoplasty: hemodynamics and comparison to the intraaortic balloon pump. , 2003, The Journal of surgical research.

[76]  E. Birks,et al.  Molecular Changes Occurring During Reverse Remodelling Following Left Ventricular Assist Device Support , 2010, Journal of cardiovascular translational research.

[77]  Kiyotaka Fukamachi,et al.  In vivo acute performance of the Cleveland Clinic self-regulating, continuous-flow total artificial heart. , 2010, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[78]  Roland Hetzer,et al.  Long-term biventricular support with the heartware implantable continuous flow pump. , 2010, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[79]  William E Cohn,et al.  Induced pulsation of a continuous-flow total artificial heart in a mock circulatory system. , 2010, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[80]  K. Fukamachi,et al.  Acute In Vivo Evaluation of an Implantable Continuous Flow Biventricular Assist System , 2008, ASAIO journal.

[81]  Tadahiko Shinshi,et al.  Third-generation blood pumps with mechanical noncontact magnetic bearings. , 2006, Artificial organs.

[82]  S. Hunt Mechanical circulatory support: new data, old problems. , 2007, Circulation.

[83]  Kiyotaka Fukamachi,et al.  Speed Modulation of the Continuous-Flow Total Artificial Heart to Simulate a Physiologic Arterial Pressure Waveform , 2010, ASAIO journal.

[84]  Marvin A. Konstam,et al.  Emerging ventricular assist devices for long-term cardiac support , 2010, Nature Reviews Cardiology.

[85]  J. Piek,et al.  Percutaneous left ventricular assist devices for high-risk percutaneous coronary intervention , 2010, Expert review of cardiovascular therapy.

[86]  S. Schenk,et al.  Preclinical readiness testing of the Arrow International CorAide left ventricular assist system. , 2004, The Annals of thoracic surgery.

[87]  M C Oz,et al.  Implantable left ventricular assist devices. , 1998, The New England journal of medicine.

[88]  Daniel Tamez,et al.  Total Heart Replacement with Dual Centrifugal Ventricular Assist Devices , 2005, ASAIO journal.

[89]  L. Stevenson,et al.  Third INTERMACS Annual Report: the evolution of destination therapy in the United States. , 2011, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[90]  Satoshi Saito,et al.  Completely pulsatile high flow circulatory support with a constant-speed centrifugal blood pump: mechanisms and early clinical observations , 2007, General thoracic and cardiovascular surgery.

[91]  A. Kantrowitz,et al.  Intraaortic balloon pumping for prolonged circulatory support. , 1988, The American journal of cardiology.

[92]  K. Fukamachi,et al.  Development of DexAide Right Ventricular Assist Device: Update II , 2008, ASAIO journal.

[93]  P. Verdonck,et al.  The impact of pump speed and inlet cannulation site on left ventricular unloading with a rotary blood pump. , 2004, Artificial organs.

[94]  K. Kamohara,et al.  Development of a Small Implantable Right Ventricular Assist Device , 2005, ASAIO journal.

[95]  Sachin H. Shah,et al.  Skeletal muscle ventricle aortic counterpulsation: function during chronic heart failure. , 2002, The Annals of thoracic surgery.

[96]  Alan F Merry,et al.  Extra-Aortic Balloon Counterpulsation: An Intraoperative Feasibility Study , 2005, Circulation.

[97]  Magdi H Yacoub,et al.  Left ventricular assist device and drug therapy for the reversal of heart failure. , 2006, The New England journal of medicine.

[98]  M. Oz,et al.  Right ventricular dysfunction and organ failure in left ventricular assist device recipients: a continuing problem. , 2002, The Annals of thoracic surgery.

[99]  K. Litwak,et al.  HeartMate III: Pump Design for a Centrifugal LVAD with a Magnetically Levitated Rotor , 2001, ASAIO journal.

[100]  C. Pierrakos,et al.  Superior Performance of a Paraaortic Counterpulsation Device Compared to the Intraaortic Balloon Pump , 2003, World Journal of Surgery.

[101]  Kiyotaka Fukamachi,et al.  An innovative, sensorless, pulsatile, continuous-flow total artificial heart: device design and initial in vitro study. , 2010, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[102]  Carlo Pellegrini,et al.  Arrow CorAide left ventricular assist system: initial experience of the cardio-thoracic surgery center in Pavia. , 2007, The Annals of thoracic surgery.

[103]  Kenji Yamazaki,et al.  Preclinical biocompatibility assessment of the EVAHEART ventricular assist device: coating comparison and platelet activation. , 2007, Journal of biomedical materials research. Part A.

[104]  J F Antaki,et al.  Rotary blood pump flow spontaneously increases during exercise under constant pump speed: results of a chronic study. , 1999, Artificial organs.

[105]  M C Oz,et al.  Long-term use of a left ventricular assist device for end-stage heart failure. , 2001, The New England journal of medicine.

[106]  M. Slaughter,et al.  A novel subcutaneous counterpulsation device: acute hemodynamic efficacy during pharmacologically induced hypertension, hypotension, and heart failure. , 2010, Artificial organs.

[107]  Julian A. Smith,et al.  Extra-aortic implantable counterpulsation pump in chronic heart failure. , 2008, The Annals of thoracic surgery.

[108]  Kiyotaka Fukamachi,et al.  Cleveland Clinic CorAide Blood Pump Circulatory Support Without Anticoagulation , 2002, ASAIO journal.

[109]  K. Fukamachi,et al.  Use of zirconia ceramic in the DexAide right ventricular assist device journal bearing. , 2010, Artificial organs.