Mechanical circulatory support: Technical tips for the implantation of a right ventricular assist deviceCentral Message

Central MessageA modification of HeartMate 3 when used as an RVAD is polytetrafluoroethylene ring augmentation of the inflow cannula to reduce the intraluminal part of the cannula. A complication is pump thrombosis.See Commentary on page 41.Small, implantable continuous-flow pumps were introduced into clinical practice in 1998.1Potapov E.V. Loebe M. Nasseri B.A. Sinawski H. Koster A. Kuppe H. et al.Pulsatile flow in patients with a novel nonpulsatile implantable ventricular assist device.Circulation. 2000; 102: III183-III187PubMed Google Scholar Conceptually designed as devices for bridge to transplantation, most devices are currently implanted as long-term support devices.2Potapov E.V. Kaufmann F. Müller M. Mulzer J. Falk V. Longest ongoing support (13 years) with magnetically levitated left ventricular assist device.ASAIO J. 2020; 66: e121-e122Crossref PubMed Scopus (4) Google Scholar Paracorporeal pumps, except in the pediatric population, are rarely used. Due to the limited availability and complexity of total artificial hearts (TAHs), these systems are almost exclusively used for patients in emergency settings with no other support option. As a result, there is a growing need for a continuous-flow biventricular assist device (cfBIVAD). Left ventricular assist device (LVAD) pumps, which were developed for supporting the systemic circulation, can also assist the right ventricle (RV).3Krabatsch T. Potapov E. Stepanenko A. Schweiger M. Kukucka M. Huebler M. et al.Biventricular circulatory support with two miniaturized implantable assist devices.Circulation. 2011; 124: S179-S186Crossref PubMed Scopus (150) Google Scholar Up to now, no commercially available implantable device is approved by the Food and Drug Administration or the European Medicines Agency for RV support, neither as isolated support of the RV nor in a biventricular mode. At the same time, the only commercially available device in the United States, the paracoroporeal Thoratec (Abbott Cardiovascular, Abbott Park, Ill) RV assist device (RVAD), has not been available for quite some time. The alternative is cardiectomy and implantation of the SynCardia (SynCardia Systems, Tucson, Ariz) TAH device or the Aeson TAH (Carmat, Vélizy-Villacoubay, France) device, which are both approved by the European Medicines Agency.Long-term mechanical circulatory support has emerged as a subspecialty of cardiac surgery. In Germany, only 3 out of 77 heart centers perform more than 200 VAD operations annually, and only an additional 4 centers perform around 100 operations per year. Most surgeries involve the implantation of single-ventricle support devices. During this period, the use of cfBIVAD and TAH was almost negligible. Between 2013 and 2019, only 14 to 68 BIVADs were implanted annually. Of approximately 1000 long-term mechanical circulatory support systems implanted annually during the same period, only 7 to 27 per year were TAH implantations.4German heart report 2020 [article in German].https://www.herzstiftung.de/system/files/2021-06/Deutscher-Herzbericht-2020.pdfGoogle ScholarThe differences between implantable cfBIVAD and TAH are presented in Table 1. No direct comparisons were ever performed in a trial, and hence Table 1 represents only an expert opinion on the available studies on cfBIVAD or TAH.Table 1Total artificial heart (TAH) and continuous-flow biventricular assist device (cfBIVAD)VariableTAHcfBIVAD1-y survivalSimilar∗The Intermacs analysis reports 1-year survival of 59% for TAH and of 56% for cfBVAD.5Similar∗The Intermacs analysis reports 1-year survival of 59% for TAH and of 56% for cfBVAD.5Device functionEntirely dependent on device functionPartially dependent on device functionSuccessful resuscitation in case of device malfunctionNot possiblePossible, if residual function of ventricles is presentSuitable for small body sizesNoYesSuitable for small ventricles/restrictive cardiomyopathyYesNo∗ The Intermacs analysis reports 1-year survival of 59% for TAH and of 56% for cfBVAD.5Kirklin J.K. Naftel D.C. Pagani F.D. Kormos R.L. Stevenson L.W. Blume E.D. et al.Seventh INTERMACS annual report: 15,000 patients and counting.J Heart Lung Transplant. 2015; 34: 1495-1504Abstract Full Text Full Text PDF PubMed Scopus (1019) Google Scholar Open table in a new tab There are many reasons why a direct comparison between TAH and cfBIVAD and comparisons between different publications must be interpreted with caution. First, mortality is usually driven by the indication, as exemplified by the fact that 90% of deaths after TAH occur within the first 40 days.6Copeland J.C. Copeland H. Gustafson M. Mineburg N. Covington D. Smith R.G. et al.Experience with more than 100 total artificial heart implants.J Thorac Cardiovasc Surg. 2012; 143: 727-734Abstract Full Text Full Text PDF PubMed Scopus (117) Google Scholar Second, the transplant rate differs considerably between regions. In Spain, with 47.3 million inhabitants, 321 cardiac transplants were performed during 2018.7González-Vílchez F. Almenar-Bonet L. Crespo-Leiro M.G. Segovia-Cubero J. Gonzalez-Costello J. Del Prado J.M.A. et al.Spanish Heart Transplant Teams Spanish Heart Transplant Registry30th official report of the Spanish Society of Cardiology working group on heart failure (1984-2018).Rev Esp Cardiol (Engl Ed). 2019; 72: 954-962PubMed Google Scholar,8EuroStatFirst population estimates: EU population in 2020 at almost 448 million: More deaths than births [press release in German].https://ec.europa.eu/eurostat/documents/2995521/11081097/3-10072020-AP-DE.pdf/7f863daa-c1ac-758f-e82b-954726c4621fGoogle Scholar In contrast, in Germany, with a population of 83.2 million; that the population of Spain, cardiac transplants were heart and heart report 2020 [article in German].https://www.herzstiftung.de/system/files/2021-06/Deutscher-Herzbericht-2020.pdfGoogle Scholar,8EuroStatFirst population estimates: EU population in 2020 at almost 448 million: More deaths than births [press release in German].https://ec.europa.eu/eurostat/documents/2995521/11081097/3-10072020-AP-DE.pdf/7f863daa-c1ac-758f-e82b-954726c4621fGoogle Scholar In a report by and E. M. et with biventricular assist Heart Lung Transplant. Full Text Full Text PDF PubMed Scopus Google Scholar patients with cfBIVAD a heart In the cfBIVAD the rate was F. N. M. Mulzer J. et implantable continuous-flow ventricular assist devices in a biventricular and Cardiovasc Thorac Surg. PubMed Scopus Google Scholar transplant and in different can the of TAH and cfBIVAD of this is to the for and for the HeartMate 3 (Abbott to support a There are different for long-term of RV failure after by In a is of RV failure or after biventricular RV failure to or as E.V. T. A. T. of a with after and mechanical circulatory Thorac Cardiovasc Surg. 2015; Full Text Full Text PDF PubMed Scopus Google H. T. right ventricular assist device implantation with the continuous-flow ventricular assist first the European for patients with mechanical circulatory Surg. 2015; PubMed Scopus Google 4 for the same implantation a right or a RV implantation of the inflow cannula and the to the The most is RV implantation was in of in a Society of Intermacs J. J.C. J. M. et Society of annual report: the of devices and Thorac Surg. 2020; Full Text Full Text PDF PubMed Scopus Google the rate of RV failure in patients is there is no and the are not The of in HeartMate 3 right heart failure in of patients at with per in patients with a HeartMate 3 N. J.C. M. et magnetically levitated left ventricular assist 2019; PubMed Scopus Google Scholar was that an RV assist N. J.C. M. et magnetically levitated left ventricular assist 2019; PubMed Scopus Google Scholar The Intermacs report right heart failure in of the patients at 1 in at 1 and in at J. J.C. J. M. et Society of annual report: the of devices and Thorac Surg. 2020; Full Text Full Text PDF PubMed Scopus Google Scholar heart failure is during the first A at a analysis of the Intermacs the of RV support into to were with only biventricular both and the same period, were implanted and patients an isolated R.L. J. Pagani F.D. et Society of annual report: and Heart Lung Transplant. 2019; Full Text Full Text PDF PubMed Scopus Google Scholar at the long-term for the of RV failure in patients with heart support and TAH In to the TAH devices SynCardia TAH and Aeson TAH are approved for patients with biventricular failure as bridge to total artificial heart is approved for in the United PubMed Scopus Google M. A. Heart after total artificial heart Surg. 2020; PubMed Google Scholar of is that are not for patients with most TAH currently available for clinical use is the SynCardia analysis of the Intermacs between and reports a 1-year survival of 56% for cfBIVAD and of 59% for J.K. Naftel D.C. Pagani F.D. Kormos R.L. Stevenson L.W. Blume E.D. et al.Seventh INTERMACS annual report: 15,000 patients and counting.J Heart Lung Transplant. 2015; 34: 1495-1504Abstract Full Text Full Text PDF PubMed Scopus (1019) Google by Copeland and J.C. Copeland H. Gustafson M. Mineburg N. Covington D. Smith R.G. et al.Experience with more than 100 total artificial heart implants.J Thorac Cardiovasc Surg. 2012; 143: 727-734Abstract Full Text Full Text PDF PubMed Scopus (117) Google Scholar is that 90% of deaths after TAH implantation occur during the first 40 TAH was used as a bridge to to was by and M. L. V. V. et with SynCardia total artificial heart 1 J. PubMed Scopus Google Scholar that a with of patients implanted with a TAH of failure to an and E. M. et with biventricular assist Heart Lung Transplant. Full Text Full Text PDF PubMed Scopus Google Scholar report failure in and in of patients as of E. M. et with biventricular assist Heart Lung Transplant. Full Text Full Text PDF PubMed Scopus Google Scholar The if small in patients with a is an and the of is to in to patients with a TAH are dependent on device In the case of a device in patients with a is for the heart to cardiac the device ca

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