Anastasiadis K, Papaconstantinou C. Mechanical support of patients with dilated cardiomyopathy. Epitheorese Klin Farmakol Farmakokinet. 2010;28(2):197-202 Review Anastasiadis K, Antonitsis P, Chalvatzoulis O, Papakonstantinou C. Use of a short-term mechanical circulatory support device for cardiac recovery. J Heart Lung Transplant. 2011 Jun;30(6):732-3 Device used is not magnetically levitated centrifugal pump CentriMag or PediVAS/PediMag, manufactured by Levitronix or Thoratec Anderson E, Jaroszewski D, Pierce C, DeValeria P, Arabia F. Parallel application of extracorporeal membrane oxygenation and the Cardiowest artificial heart as a bridge to transplant. Ann Thorac Surg. 2009 Nov;88(5):1676-8 Case report of CentriMag (assessment of clinical effectiveness) Askegard-Giesmann JR, Besner GE, Fabia R, Caniano DA, Preston T, Kenney BD. Extracorporeal membrane oxygenation as a lifesaving modality in the treatment of pediatric patients with burns and respiratory failure. J Pediatr Surg. 2010 Jun;45(6):1330-5 Device name is not reported Aubert S, Leprince P, Bonnet N, Barreda T, Ouattara A, Varnous S, Pavie A, Gandjbakhch I. Limited mechanical circulatory support following orthotopic heart transplantation. Interact Cardiovasc Thorac Surg. 2006 Apr;5(2):88-9 Device name is not reported Editorial Bakhtiary F, Keller H, S, Dzemali O, Oezaslan F, Meininger D, Ackermann H, Zwissler B, Kleine P, Moritz A. Venoarterial extracorporeal membrane oxygenation for treatment of cardiogenic shock: clinical experiences in 45 adult patients. J Thorac Cardiovasc Surg. 2008 Feb;135(2):382-8 Device used is not magnetically levitated centrifugal pump CentriMag or PediVAS/PediMag, manufactured by Levitronix or Thoratec
neonatal period at the royal children's hospital, Melbourne. Pediatr Crit Care Med. 2011;12(3):A59-A60 Busch T, Laudi S, Kaisers U. Ventilatory support versus ECMO for severe adult respiratory failure. Lancet 2010 Feb 13;375(9714):549 Letter Bedossa M, Flecher E, Guillaume L, Bertheuil N, Fouquet O, Bellouin A, Verhoye JP. Acute myocardial infarction and refractory shock: Is there a way with ECMO? Analysis of the results of a French center. Catheterization and Cardiovascular Interventions 2010; 75 Suppl. 2 (S62-S63) Device name is not reported Beiderlinden M, Eikermann M, Boes T, Breitfeld C, Peters J. Treatment of severe respiratory distress syndrome: role of extracorporeal gas exchange. Intensive Care Med. 2006 Oct;32(10):1627-31 Device used is not magnetically levitated centrifugal pump CentriMag or PediVAS/PediMag, manufactured by Levitronix or Thoratec Bein T, Graf B, Weber-Carstens S. Ventilatory support versus ECMO for severe adult respiratory failure. Lancet 2010 Feb 13;375(9714):549-50 Letter Beitzke D, Wieselthaler G, Schima H, Loewe C. Pulmonary embolism in a patient with a biventricular assist device--imaging with multislice computed tomography. Eur J Cardiothorac Surg. 2011 Mar;39(3):415 Device used is not magnetically levitated centrifugal pump CentriMag or PediVAS/PediMag, manufactured by Levitronix or Thoratec Belle L, Mangin L, Bonnet H, Fol S, Santre C, Bougon D, Vialle E, Dompnier A, Desjoyaux E, Blin D. Emergency extra-corporeal membrane oxygenation in cardiac shock and cardiac arrest in hospital without on-site cardiac surgical facilities. Eur. Heart J. 2011;32(S1):80-81 Device name is not reported trial
fluids for in vitro evaluation of potential blood damage in blood pumps. ASAIO J 2010 Jan-Feb;56(1):6-11 D'Ancona G, Capitanio G, Chiaramonte G, Serretta R, Turrisi M, Pilato M, Arcadipane A. Extracorporeal membrane oxygenator rescue and airborne transportation of patients with influenza A (H1N1) acute respiratory distress syndrome in a Mediterranean underserved area. Interact Cardiovasc Thorac Surg. 2011 Jun;12(6):935-7 Device used is not magnetically levitated centrifugal pump CentriMag or PediVAS/PediMag, manufactured by Levitronix or Thoratec Dasse K, Gellman B, Kameneva M, Wooley J, Johnson C, Gempp T, Marks J, Kent S, Koert A, Richardson S, Franklin S, Snyder T, Wearden P, Wagner W, Gilbert R, Borovetz H. Assessment of hydraulic performance and biocompatibility of a maglev centrifugal pump system designed for pediatric cardiac or cardiopulmonary support. ASAIO J 2007;52:771-777 Technical of CentriMag pump Dassinger MS, Copeland DR, Gossett J, Little DC, Jackson RJ, SD. Congenital Diaphragmatic Hernia Study Group. Early repair of congenital diaphragmatic hernia on extracorporeal membrane oxygenation. J Pediatr Surg. 2010 Apr;45(4):693-7 Device name is not reported Davies RR, MJ, Yang J, Quaegebeur JM, Mosca RS, Chen JM. Listing and transplanting adults with congenital heart disease. Circulation. 2011 Feb 22;123(7):759-67 Device name is not reported Davies RR, Russo MJ, Hong KN, O'Byrne ML, Cork DP, Moskowitz AJ, Gelijns AC, Mital S, Mosca RS, Chen JM. The use of mechanical circulatory support as a bridge to transplantation in pediatric patients: an analysis of the United Network for Organ Sharing database. J Thorac Cardiovasc Surg. 2008 Feb;135(2):421-7 Device name is not reported
surgery. J Cardiothorac Vasc Anesth. 2010 Emin A, Rogers CA, Thomas HL, Tsui S, Schueler S, MacGowan G, Simon A, Bonser RS, Parameshwar J, Banner NR. Management of advanced heart failure in the UK: Trends in heart transplantation and mechanical circulatory support. Heart 2011;97:A48-A49 Device name is not reported Factora FN, Bustamante S, Spiotta A, Avitsian R. Intracranial hemorrhage surgery on patients on mechanical circulatory support: a case series. J Neurosurg Anesthesiol. 2011 Jan;23(1):30-4 Device name is not reported Ferrari M, Hekmat K, Jung C, Ferrari-Kuehne K, Pfeifer R, Schlosser MH, Werner GS, Figulla HR. Better outcome after cardiopulmonary resuscitation using percutaneous emergency circulatory support in non-coronary patients compared to those with myocardial infarction. Acute Card Care. 2011 Mar;13(1):30-4 Device used is not magnetically levitated centrifugal pump CentriMag or PediVAS/PediMag, manufactured by Levitronix or Thoratec Field D, Elbourne D, Hardy P, Fenton AC, Ahluwalia J, Halliday HL, Subhedar N, Heinonen K, Aikio O, Grieve R, Truesdale A, Tomlin K, Normand C, Stocks J. INNOVO Collaborating Group. Neonatal ventilation with inhaled nitric oxide vs. ventilatory support without inhaled nitric oxide for infants with severe respiratory failure born at or near term: the INNOVO multicentre randomised controlled trial. Neonatology 2007;91(2):73-82 Device name is not reported. Impact of VAD/ECMO on outcomes is not assessed Field DJ, Firmin R, Azzopardi DV, Cowan F, Juszczak E, Brocklehurst P; NEST Study Group. Neonatal ECMO Study of Temperature (NEST)--a randomised controlled trial.BMC Pediatr. 2010 Apr 19;10:24 Description of the NEST methodology
Jainandunsing JS, Ismael F. Ventilatory support versus ECMO for severe adult respiratory failure. Lancet 2010 Feb 13;375(9714):549. Letter. Jaroszewski D, Marranca M, Pierce C, Wong R, Steidley E, Scott R, DeValeria P, Arabia F. Successive circulatory support stages: a triple bridge to recovery from fulminant myocarditis. J Heart Lung Transplant. 2009 Case report.of CentriMag (assessment of clinical effectiveness) Jaschinski UJ, Kierschke G, Forst H, Beyer M. Extracorporal membrane oxygenation for cardiopulmonary support after open heart surgery. Crit Care. 2011;15:S4 Device name is not reported Johnson CA Jr, Shankarraman V, Wearden PD, Kocyildirim E, Maul TM, JD, Richardson JS, Gellman BN, Borovetz HS, Dasse KA, Wagner WR. Platelet activation after implantation of the Levitronix PediVAS in the ovine model. ASAIO J. 2011 Animal study of CentriMag Jokinen JJ, Hämmäinen P, Raivio P, Werkkala K, Sipponen J, Lemström KB. Ventricular assist devices program in finland-ten years after Heart Surg. Forum 2011;14(S2):S31 Device used is not magnetically levitated centrifugal pump CentriMag or PediVAS/PediMag, manufactured by Levitronix or Thoratec Josan K, Cheung A, Kaan A, Ignaszewski A, Bashir J, Toma M. Right ventricular dysfunction should not preclude left ventricular assist device explantation in patients exhibiting left ventricular recovery. Circulation 2011;124(21) Device name is not reported Jung C, Lauten A, Ferrari M. Microcirculation in cardiogenic shock: from scientific bystander to therapy target. Crit Care. 2010;14(5):193 Review
ex vivo. Interact Cardiovasc Thorac Surg. 2011 Feb;12(2):162-5 Thoratec. Impact of VAD/ECMO on outcomes is not assessed Linneweber L, Konertz W. Clinical Experience with the Levitronix CentriMag Ventricular Assist System. ISRBP 2005. (Abstract) Excluded because of inconsistent reporting of outcomes Listijono DR, Watson A, Pye R, Keogh AM, Kotlyar E, Spratt P, Granger E, Dhital K, Jansz P, Macdonald PS, Hayward CS. Usefulness of extracorporeal membrane oxygenation for early cardiac allograft dysfunction.J Heart Lung Transplant. 2011 Jul;30(7):783-9 Device name is not reported Litmathe J, Sucker C, Easo J, Wigger L, Dapunt O.Prone and ECMO - a contradiction per se?. Perfusion. 2012 Jan;27(1):78-82 Device name is not reported Liu Y, Cheng YT, Chang JC, Chao SF, Chang BS. Extracorporeal membrane oxygenation to support prolonged conventional cardiopulmonary resuscitation in adults with cardiac arrest from acute myocardial infarction at a very low-volume centre. Interact Cardiovasc Thorac Surg. 2011 Mar;12(3):389-93 Device used is not magnetically levitated centrifugal pump CentriMag or PediVAS/PediMag, manufactured by Levitronix or Thoratec Loforte A, Monica PL, Musumeci F. A unique case of driveline fracture in a continuous-flow mechanical support device.J Heart Lung Transplant. 2011 Aug;30(8):967-8 Device used is not magnetically levitated centrifugal pump CentriMag or PediVAS/PediMag, manufactured by Levitronix or Thoratec López-Saubidet I, Rodríguez PO, Maskin P, Attie S, Bonelli I, Valentini R. (Utilization of extracorporeal membrane oxygenation in late stage of the acute respiratory distress syndrome). Med Intensiva. 2011 Oct;35(7):448-50 Device name is not reported. Case study
manufactured by Levitronix or Thoratec Shah SA, Shankar V, Churchwell KB, Taylor MB, Scott BP, Bartilson R, Byrne DW, Christian KG, Drinkwater DC. Clinical outcomes of 84 children with congenital heart disease managed with extracorporeal membrane oxygenation after cardiac surgery. ASAIO J 2005 Device used is not magnetically levitated centrifugal pump CentriMag or PediVAS/PediMag, manufactured by Levitronix or Thoratec Sharma MS, Forbess JM, Guleserian KJ. Ventricular assist device support in children and adolescents with heart failure: The children's medical of dallas experience. Artif Organs 2011;35(4):A7 Device used is not magnetically levitated centrifugal pump CentriMag or PediVAS/PediMag, manufactured by Levitronix or Thoratec Sharples LD, Cafferty F, Demitis N, Freeman C, Dyer M, Banner N, Birks EJ, Khaghani A, Large SR, Tsui S, Caine N, Buxton M. Evaluation of the clinical effectiveness of the Ventricular Assist Device Program in the United Kingdom (EVAD UK). J Heart Lung Transplant. 2007 Device used is not magnetically levitated centrifugal pump CentriMag or PediVAS/PediMag, manufactured by Levitronix or Thoratec Sharples L, Buxton M, Caine N, Cafferty F, Demiris N, Dyer M, Freeman C. Evaluation of the ventricular assist device programme in the UK. Health Technol Assess. 2006 Nov;10(48):1-119, iii-iv Device used is not magnetically levitated centrifugal pump CentriMag or PediVAS/PediMag, manufactured by Levitronix or Thoratec Sharples LD, Dyer M, Cafferty F, Demiris N, Freeman C, Banner NR, Large SR, Tsui S, Caine N, Buxton M. of ventricular assist device use in the United Kingdom: results from the evaluation of ventricular assist device programme in the UK (EVAD-UK). J Heart Lung Transplant. 2006 Nov;25(11):1336-43 Device used is not magnetically levitated centrifugal pump CentriMag or PediVAS/PediMag, manufactured by Levitronix or Thoratec effectiveness
manufactured by Levitronix or Thoratec. Case report Tarzia V, Gasparetto N, Cacciavillani L, Bottio T, Bianco R, Marra MP, Hiso E, Marzari A, Iliceto S, Gerosa G. Extracorporeal membrane oxygenation as a bridge to life for refractory cardiogenic shock. Circulation. 2011;124(21);S1 Device name is not reported Taskin ME, Fraser KH, Zhang T, Gellman B, Fleischli A, Dasse KA, Griffith BP, Wu ZJ. Computational Characterization of Flow and Hemolytic Performance of the UltraMag Blood Pump for Circulatory Support. Artif Organs. 2010 Dec;34(12):1099-113. doi: Device used is not magnetically levitated centrifugal pump CentriMag or PediVAS/PediMag, manufactured by Levitronix or Thoratec. Technical study Tayama E, Aoyagi S. Timing of conversion from percutaneous cardiopulmonary support system to left ventricular assist system for severe fulminant myocarditis. Ann Thorac Cardiovasc Surg. 2010 Aug;16(4):301-2 Device name is not reported Tedford RJ, James C, Judge DP, Tichnell C, Murray B, Bhonsale A, Philips B, Abraham T, Dalal D, Halushka MK, Tandri H, Calkins H, Russell SD. Cardiac transplantation in arrhythmogenic right ventricular dysplasia/cardiomyopathy. J Am Coll Cardiol. 2012 Jan 17;59(3):289-90 Device name is not reported SA, Allan CK, Laussen PC, Newburger JW, Gauvreau K, Thiagarajan RR. Management and outcomes in pediatric patients presenting with acute fulminant myocarditis. J Pediatr. 2011 Apr;158(4):638-643.e1 Device name is not reported Thiagarajan RR, Laussen PC, Rycus PT, Bartlett RH, Bratton SL. Extracorporeal membrane oxygenation to aid Device name is not reported
Meta-analysis of and safety outcomes Table 7. Meta-analysis of effectiveness outcomes, survival (random-effect model) Indication Survival, percentage (95% confidence interval), I2 N studies (n pts) On support N studies (n pts) At discharge N studies (n pts) 30-day N studies (n pts) 90-day N studies (n pts) 6-month N studies (n pts) 1-year VAD support in pre-cardiotomy cardiogenic indication 5 (45) 78% (48-97%), I2=75.4% 3 (23) 75% (32-99%), I2=74.2% 6 (69) 67% (45-86%), I2=71.7% 3 (29) 78% (45-98%), I2=67.3% 4 (46) 73% (47-93%), I2=69.2% 3 (32) 78% (47-97%), I2=67% VAD support in post-cardiac surgery cardiogenic shock indication 4 (32) 79% (43-99%), I2=62.3% 6 (32) 61% (29-88%), I2= 65% 5 (65) 41% (30-54%), I2= 0% - - 2 (20) 37% (3-82%), I2= 78.4% - - VAD support in post-transplant rejection or failure indication 3 (40) 91% (35-100%), I2= 84.1% 2 (12) 84% (23-100%), I2= 68% 3 (45) 54% (39-68%), I2= 0% - - - - - - VAD support in post-LVAD placement right ventricular failure indication 6 (58) 87% (70-97%), I2= 57% 4 (54) 67% (38-91%), I2=77.5% 3 (41) 40% (2-88%), I2=90% - - - - - - Pts – patients; VAD, ventricular assist device.
Table 8. Meta-analysis of effectiveness outcomes, weaning from support or bridging to repeat heart transplant or VAD (random-effect model) Indication Survival, percentage (95% confidence interval), I2 N studies (n pts) Proportion of patients weaned from support or bridged to heart transplant or bridged to VAD (95% CI) N studies (n pts) Proportion of patients weaned from support or bridged to heart transplant (95% CI) VAD support in post-transplant graft rejection or failure indication - - 5 (55) 81% (54-98%), I2=70.3% VAD support in post-LVAD placement right ventricular failure indication 8 (82) 80% (64-92%), I2=58.6% - - Pts – patients; VAD, ventricular assist device.
11. Meta-analysis of effectiveness outcomes with exclusion of studies, which contribute to heterogeneity (fixed-effect model) Indication Survival, percentage (95% confidence interval) N studies (n pts) On support N studies (n pts) At discharge N studies (n pts) 30-day VAD support in pre-cardiotomy cardiogenic indication 4 (40) 88% (76-96%) - - 5 (60) 72% (60-83%) VAD support in post-LVAD placement right ventricular failure indication - - 3 (48) 54% (40-68%) 2 (36) 73% (57-86%) Pts – patients; VAD, ventricular assist device.