HeartWare miniaturized intrapericardial ventricular assist device: Advantages and adverse events in comparison to contemporary devices

Expert Review of Medical Devices

Volumn 10, Issue 4, 2013, Pages 441-452

  Sabashnikov, Anton ^a   Mohite, Prashant N ^a   Simon, André R ^a   Popov, Aron F ^a  

^a HAREFIELD HOSPITAL   (United Kingdom)

Author keywords

HeartWare; HVAD; ventricular assist device

Indexed keywords

CARDIAC TRANSPLANTATION; CONGENITAL HEART DISEASE; DESTINATION THERAPY; HEART TRANSPLANTATION; HEARTWARE; HVAD; VENTRICULAR ASSIST DEVICE; VENTRICULAR ASSIST SYSTEM;

BLOOD PRESSURE; CARDIOLOGY; LEFT VENTRICULAR ASSIST DEVICES; PATIENT REHABILITATION; SECONDARY RECOVERY;

FIBER OPTIC SENSORS;

ARTICLE; CONGENITAL HEART DISEASE; CONTROLLED STUDY; HEART FAILURE; HEART TRANSPLANTATION; HUMAN; LEFT VENTRICULAR ASSIST DEVICE; LUNG VASCULAR RESISTANCE; OFF PUMP SURGERY; VENTRICULAR ASSIST DEVICE; ADOLESCENT; ANIMAL; COMPARATIVE STUDY; ELECTRONICS; HEART ASSIST DEVICE; HEART DEFECTS, CONGENITAL; PATHOPHYSIOLOGY; TRENDS; VASCULAR RESISTANCE;

ADOLESCENT; ANIMALS; HEART DEFECTS, CONGENITAL; HEART FAILURE; HEART-ASSIST DEVICES; HUMANS; MINIATURIZATION; VASCULAR RESISTANCE;

EID: 84881095694     PISSN: 17434440     EISSN: 17452422     Source Type: Journal    
DOI: 10.1586/17434440.2013.811851     Document Type: Article

References (77)

1. Birks EJ, Yacoub MH, Banner NR, Khaghani A. The role of bridge to transplantation: Should LVAD patients be transplanted? Curr. Opin. Cardiol. 19(2), 148-153 (2004
2. Goldstein DJ, Oz MC, Rose EA. Implantable left ventricular assist devices. N. Engl. J. Med. 339(21), 1522-1533 (1998
3. Slaughter MS, Rogers JG, Milano CA et al.; HeartMate II Investigators. Advanced heart failure treated with continuous-flow left ventricular assist device. N. Engl. J. Med. 361(23), 2241-2251 (2009
4. Rogers JG, Aaronson KD, Boyle AJ et al.; HeartMate II Investigators. Continuous flow left ventricular assist device improves functional capacity and quality of life of advanced heart failure patients. J. Am. Coll. Cardiol. 55(17), 1826-1834 (2010
5. Lahpor Jr. State of the art: Implantable ventricular assist devices. Curr. Opin. Organ Transplant. 14(5), 554-559 (2009
6. Larose JA, Tamez D, Ashenuga M, Reyes C. Design concepts and principle of operation of the HeartWare ventricular assist system. ASAIO J. 56(4), 285-289 (2010
7. HeartWare International, Inc. HeartWare® Ventricular Assist System. Instructions for Use. HeartWare International, Inc., MA, USA (2012
8. Wieselthaler GM, O Driscoll G, Jansz P, Khaghani A, Strueber M; HVAD Clinical Investigators. Initial clinical experience with a novel left ventricular assist device with a magnetically levitated rotor in a multi-institutional trial. J. Heart Lung Transplant. 29(11), 1218-1225 (2010
9. Strueber M, O'Driscoll G, Jansz P, Khaghani A, Levy WC, Wieselthaler GM; HeartWare Investigators. Multicenter evaluation of an intrapericardial left ventricular assist system. J. Am. Coll. Cardiol. 57(12), 1375-1382 (2011
10. HeartWare International, Inc. US FDA Executive Summary. The Meeting of the Circulatory System Devices Panel P100047, April 25, 2012. HeartWare International, Inc., MA, USA (2013
11. Miller LW, Pagani FD, Russell SD et al.; HeartMate II Clinical Investigators. Use of a continuous-flow device in patients awaiting heart transplantation. N. Engl. J. Med. 357(9), 885-896 (2007
12. Aaronson KD, Slaughter MS, Miller LW et al.; HeartWare Ventricular Assist Device (HVAD) Bridge to Transplant ADVANCE Trial Investigators. Use of an intrapericardial, continuous-flow, centrifugal pump in patients awaiting heart transplantation. Circulation 125(25), 3191-3200 (2012
13. Strueber M, Meyer AL, Malehsa D, Haverich A. Successful use of the HeartWare HVAD rotary blood pump for biventricular support. J. Thorac. Cardiovasc. Surg. 140(4), 936-937 (2010
14. Loforte A, Monica PL, Montalto A, Musumeci F. HeartWare third-generation implantable continuous flow pump as biventricular support: Mid-Term follow-up. Interact. Cardiovasc. Thorac. Surg. 12(3), 458-460 (2011
15. Hetzer R, Krabatsch T, Stepanenko A, Hennig E, Potapov EV. Long-Term biventricular support with the HeartWare implantable continuous flow pump. J. Heart Lung Transplant. 29(7), 822-824 (2010
16. McGee EC Jr, Ahmad U, Tamez D et al. Biventricular continuous flow VADs demonstrate diurnal flow variation and lead to end-organ recovery. Ann. Thorac. Surg. 92(1), e1-e3 (2011
17. Krabatsch T, Potapov E, Stepanenko A et al. Biventricular circulatory support with two miniaturized implantable assist devices. Circulation 124(11 Suppl.), S179-S186 (2011
18. Stepanenko A, Krabatsch T, Hennig E et al. Retrospective hemolysis comparison between patients with centrifugal biventricular assist and left ventricular assist devices. ASAIO J. 57(5), 382-387 (2011
19. Krabatsch T, Stepanenko A, Schweiger M et al. Alternative technique for implantation of biventricular support with HeartWare implantable continuous flow pump. ASAIO J. 57(4), 333-335 (2011
20. Stulak JM, Griffith KE, Nicklas JM, Pagani FD. The use of the HeartWare HVAD for long-Term right ventricular support after implantation of the Heart-Mate II device. J. Thorac. Cardiovasc. Surg. 142(3), e140-e142 (2011
21. Gregoric ID, La Francesca S, Myers T et al. A less invasive approach to axial flow pump insertion. J. Heart Lung Transplant. 27(4), 423-426 (2008
22. Cheung A, Bashir J, Kaan A, Kealy J, Moss R, Shayan H. Minimally invasive, off-pump explant of a continuous-flow left ventricular assist device. J. Heart Lung Transplant. 29(7), 808-810 (2010
23. Haj-Yahia S, Birks EJ, Dreyfus G, Khaghani A. Limited surgical approach for explanting the HeartMate II left ventricular assist device after myocardial recovery. J. Thorac. Cardiovasc. Surg. 135(2), 453-454 (2008
24. Tansley P, Yacoub M. Minimally invasive explantation of implantable left ventricular assist devices. J. Thorac. Cardiovasc. Surg. 124(1), 189-191 (2002
25. Lodge AJ. Clinical experience with sternotomy versus subcostal approach for exchange of the HeartMate XVE to the HeartMate II ventricular assist device. Invited commentary. Ann. Thorac. Surg. 85(5), 1650 (2008
26. Haj-Yahia SM, Birks EJ, Hardy J, Yacoub MH, Khaghani A. Minimally invasive technique for explantation of right ventricular assist devices. Ann. Thorac. Surg. 82(4), 1547-1548 (2006
27. Gregoric ID, Bruckner BA, Jacob L et al. Clinical experience with sternotomy versus subcostal approach for exchange of the HeartMate XVE to the HeartMate II ventricular assist device. Ann. Thorac. Surg. 85(5), 1646-1649 (2008
28. Hill JD, Avery GJ, Egrie G, Turley K, Reichenbach S. Less invasive Thoratec LVAD insertion: A surgical technique. Heart Surg. Forum 3(3), 218-223 (2000
29. Popov AF, Hosseini MT, Zych B, Simon AR, Bahrami T. HeartWare left ventricular assist device implantation through bilateral anterior thoracotomy. Ann. Thorac. Surg. 93(2), 674-676 (2012
30. Cheung A, Lamarche Y, Kaan A et al. Off-pump implantation of the HeartWare HVAD left ventricular assist device through minimally invasive incisions. Ann. Thorac. Surg. 91(4), 1294-1296 (2011
31. Sajjad M, Butt T, Oezalp F et al. An alternative approach to explantation and exchange of the HeartWare left ventricular assist device. Eur. J. Cardiothorac. Surg. doi:10.1161/CIRCULATIONAHA. 109.933960 (2012) (Epub ahead of print
32. Schweiger M, Potapov E, Vierecke J, Stepanenko A, Hetzer R, Krabatsch T. Expeditious and less traumatic explantation of a heartware LVAD after myocardial recovery. ASAIO J. 58(5), 542-544 (2012
33. Gossman MS, Graham JD, Das IJ et al. Evaluation of a ventricular assist device system: Stability in a proton beam therapy. ASAIO J. 58(6), 597-600 (2012
34. Gossman MS, Graham JD, Tamez D, Voskoboynikov N, Larose JA. Evaluation of a ventricular assist device: Stability under x-rays and therapeutic beam attenuation. ASAIO J. 58(3), 212-216 (2012
35. Lasher DE, Wojcicka JB, Malcom R, Shears LL. Case study of radiation therapy treatment of a patient with a cardiac ventricular assist device. J. Appl. Clin. Med. Phys. 9(4), 2851 (2008
36. Chelikani NM, Masterson K, Down LA et al. Effects of γ radiation on a ventricular assist device and its percutaneous lead components. ASAIO J. 58(1), 19-24 (2012
37. Kirk R, Dipchand AI, Edwards LB et al.; International Society for Heart and Lung Transplantation. The Registry of the International Society for Heart and Lung Transplantation: Fifteenth pediatric heart transplantation report -2012. J. Heart Lung Transplant. 31(10), 1065-1072 (2012
38. Almond CS, Thiagarajan RR, Piercey GE et al. Waiting list mortality among children listed for heart transplantation in the United States. Circulation 119(5), 717-727 (2009
39. Miera O, Potapov EV, Redlin M et al. First experiences with the HeartWare ventricular assist system in children. Ann. Thorac. Surg. 91(4), 1256-1260 (2011
40. D'Alessandro D, Forest SJ, Lamour J, Hsu D, Weinstein S, Goldstein D. First reported use of the heartware HVAD in the US as bridge to transplant in an adolescent. Pediatr. Transplant. 16(8), E356-E359 (2012
41. Kirklin JK, Pearce FB, Pamboukian SV et al. Implantation of the HeartWare HVAD in a child after a recent thromboembolic stroke. Ann. Thorac. Surg. 93(3), 977-978 (2012
42. Huebler M, Stepanenko A, Krabatsch T, Potapov EV, Hetzer R. Mechanical circulatory support of systemic ventricle in adults with transposition of great arteries. ASAIO J. 58(1), 12-14 (2012
43. Takeda K, Ahmad U, Malaisrie SC, Lee R, McCarthy PM, McGee EC Jr. Successful implantation of HeartWare HVAD left ventricular assist device with concomitant ascending and sinus of Valsalva aneurysms repair. J. Artif. Organs 15(2), 204-206 (2012
44. Popov AF, Hosseini MT, Zych B et al. Clinical experience with HeartWare left ventricular assist device in patients with end-stage heart failure. Ann. Thorac. Surg. 93(3), 810-815 (2012
45. Kamouh A, John R, Eckman P. Successful treatment of early thrombosis of HeartWare left ventricular assist device with intraventricular thrombolytics. Ann. Thorac. Surg. 94(1), 281-283 (2012
46. Garbade J, Bittner HB, Mohr FW, Barten MJ. Fluoroscopy-guided resolution of ingested thrombus leading to functional disturbance of a continuous-flow left ventricular assist device. Case Rep. Surg. 2012, 791056 (2012
47. Aissaoui N, Börgermann J, Gummert J, Morshuis M. HeartWare continuous-flow ventricular assist device thrombosis: The Bad Oeynhausen experience. J. Thorac. Cardiovasc. Surg. 143(4), e37-e39 (2012
48. Santise G, Sciacca S, Baglini R, Clemenza F, Pilato M Can learning to interpret pump messages help lead to an early diagnosis of HeartWare ventricular assist device thrombosis? ASAIO J. 58(6), 629-632 (2012
49. Kiernan MS, Pham DT, DeNofrio D, Kapur NK. Management of HeartWare left ventricular assist device thrombosis using intracavitary thrombolytics. J. Thorac. Cardiovasc. Surg. 142(3), 712-714 (2011
50. Shah NR, Cevik C, Hernandez A, Gregoric ID, Frazier OH, Stainback RF. Transthoracic echocardiography of the Heart-Ware left ventricular assist device. J. Card. Fail. 18(9), 745-748 (2012
51. Paluszkiewicz L, Gürsoy D, Spiliopoulos S et al. HeartMate II ventricular assist device thrombosis-An echocardiographic approach to diagnosis: Can Doppler evaluation of flow be useful? J. Am. Soc. Echocardiogr. 24(3), 350.e1-350.e4 (2011
52. Uriel N, Morrison KA, Garan AR et al. Development of a novel echocardiography ramp test for speed optimization and diagnosis of device thrombosis in continuous-flow left ventricular assist devices: The Columbia ramp study. J. Am. Coll. Cardiol. 60(18), 1764-1775 (2012
53. Aissaoui N, Paluszkiewicz L, Schulte-Eistrup S, Morshuis M, Gummert J. An atypical thrombus in the inflow cannula of the HeartWare left ventricular assist device. Ann. Thorac. Surg. 92(3), e57 (2011
54. Soleimani B, Haouzi A, Manoskey A, Stephenson ER, El-Banayosy A, Pae WE. Development of aortic insufficiency in patients supported with continuous flow left ventricular assist devices. ASAIO J. 58(4), 326-329 (2012
55. Hatano M, Kinugawa K, Shiga T et al. Less frequent opening of the aortic valve and a continuous flow pump are risk factors for postoperative onset of aortic insufficiency in patients with a left ventricular assist device. Circ. J. 75(5), 1147-1155 (2011
56. Parikh KS, Mehrotra AK, Russo MJ et al. Percutaneous transcatheter aortic valve closure successfully treats left ventricular assist device-Associated aortic insufficiency and improves cardiac hemodynamics. JACC Cardiovasc. Interv. 6(1), 84-89 (2013
57. Pauwaa S, Bhat G, Tatooles AJ et al. How effective are continuous flow left ventricular assist devices in lowering high pulmonary artery pressures in heart transplant candidates? Cardiol. J. 19(2), 153-158 (2012
58. Baumwol J, Macdonald PS, Keogh AM et al. Right heart failure and 'failure to thrive' after left ventricular assist device: Clinical predictors and outcomes. J. Heart Lung Transplant. 30(8), 888-895 (2011
59. Kormos RL, Teuteberg JJ, Pagani FD et al.; HeartMate II Clinical Investigators. Right ventricular failure in patients with the HeartMate II continuous-flow left ventricular assist device: Incidence, risk factors, and effect on outcomes. J. Thorac. Cardiovasc. Surg. 139(5), 1316-1324 (2010
60. Drakos SG, Janicki L, Horne BD et al. Risk factors predictive of right ventricular failure after left ventricular assist device implantation. Am. J. Cardiol. 105(7), 1030-1035 (2010
61. Topkara VK, Kondareddy S, Malik F et al. Infectious complications in patients with left ventricular assist device: Etiology and outcomes in the continuous-flow era. Ann. Thorac. Surg. 90(4), 1270-1277 (2010
62. Hannan MM, Husain S, Mattner F et al.; International Society for Heart and Lung Transplantation. Working formulation for the standardization of definitions of infections in patients using ventricular assist devices. J. Heart Lung Transplant. 30(4), 375-384 (2011
63. Dell'Aquila AM, Schneider SR, Schlarb D et al. Initial clinical experience with the HeartWare left ventricular assist system: A single-center report. Ann. Thorac. Surg. 95(1), 170-177 (2013
64. Kato TS, Schulze PC, Yang J et al. Pre-operative and post-operative risk factors associated with neurologic complications in patients with advanced heart failure supported by a left ventricular assist device. J. Heart Lung Transplant. 31(1), 1-8 (2012
65. Aggarwal A, Gupta A, Kumar S et al Are blood stream infections associated with an increased risk of hemorrhagic stroke in patients with a left ventricular assist device? ASAIO J. 58(5), 509-513 (2012
66. Komoda T, Drews T, Hetzer R, Lehmkuhl HB. Lower body surface area is highly related to mortality due to stroke or systemic bleeding in patients receiving an axial flow blood pump as a left ventricular assist device. Eur. J. Cardiothorac. Surg. 43(5), 1036-1042 (2013
67. Meyer AL, Malehsa D, Bara C et al. Acquired von Willebrand syndrome in patients with an axial flow left ventricular assist device. Circ. Heart Fail. 3(6), 675-681 (2010
68. Crow S, Chen D, Milano C et al. Acquired von Willebrand syndrome in continuousflow ventricular assist device recipients. Ann. Thorac. Surg. 90(4), 1263-1269; discussion 1269 (2010
69. Backes D, van den Bergh WM, van Duijn AL, Lahpor JR, van Dijk D, Slooter AJ. Cerebrovascular complications of left ventricular assist devices. Eur. J. Cardiothorac. Surg. 42(4), 612-620 (2012
70. Saeed D, Albert A, Kamiya H, Maxhera B, Westenfeld R, Lichtenberg A. Five days of no anticoagulation or antiplatelet therapy and NovoSeven administration in a HeartWare HVAD patient. Artif. Organs 36(8), 751-753 (2012
71. Hayes HM, Dembo LG, Larbalestier R, O'Driscoll G. Management options to treat gastrointestinal bleeding in patients supported on rotary left ventricular assist devices: A single-center experience. Artif. Organs 34(9), 703-706 (2010
72. Meyns BP, Simon A, Klotz S et al. Clinical benefits of partial circulatory support in New York Heart Association Class IIIB and Early Class IV patients. Eur. J. Cardiothorac. Surg. 39(5), 693-698 (2011
73. Mozes A, DeNofrio D, Pham DT, Homoud MK. Inappropriate implantable cardioverter-defibrillator therapy due to electromagnetic interference in patient with a HeartWare HVAD left ventricular assist device. Heart Rhythm 8(5), 778-780 (2011
74. Salamonsen RF, Mason DG, Ayre PJ. Response of rotary blood pumps to changes in preload and afterload at a fixed speed setting are unphysiological when compared with the natural heart. Artif. Organs 35(3), e47-e53 (2011
75. Meyer AL, Kugler C, Malehsa D, Haverich A, Strueber M. Patient satisfaction with the external equipment of implantable left ventricular assist devices. Artif. Organs 34(9), 721-725 (2010
76. Geidl L, Deckert Z, Zrunek P et al. Intuitive use and usability of ventricular assist device peripheral components in simulated emergency conditions. Artif. Organs 35(8), 773-780 (2011
77. Mohite PN, Bowles CT, Simon AR. A novel drive-line handling tool for the HeartWare ventricular assist device in patients with a physical disability. J. Heart Lung Transplant. 31(12), 1323-1325 (2012