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378                      Mechanical Circulatory Support for
                                                 Advanced Heart Failure



              (40-50% ofpatients) or 2 (25-35% of patients) and, as   reduce intracardiac filling pressures (there by reduc-
              consequence,  the  long-term survival was marginal.   ing congestion and/or pulmonary edema),  reduce
              Most of the mortality occurred during the initial hos-  ventricular volumes, wall stress, and myocardial oxy-
              pitalization  for assist  device surgery,  closely  related   gen consumption;and augment myocardial perfusion
              to the degree  of  organ  compromise  and urgency  at   by  increasing  coronary  blood flow(theoretically also
              the time of implantation, which might have been as-  limiting the infarct  size  in the  setting of myocardial
              sociated with irreversible organ dysfunction.      infarction).Each  of the  currently available devices is
                                                                 designed to tackle the entire equation (i.e. circulatory
              These  observations  have led  the heart failure  com-  support, ventricular unloading, myocardial perfusion)
              munity  to begin using temporary(acute)  mechanical   but primarily  address  specific  aspects  of  that  equa-
              circulatory support devices in order to stabilize high-  tion.
              risk patients (profiles 1-2) and downshift the risks of
              a durable assist devices implantinto defined popula-  The temporary mechanical circulatory support devic-
              tions with lower post-operative morbidity (e.g. profiles   es can be largely divided into pulsatile and non-pul-
              3-4)leading to better survival. Indeed, the most recent   satile  devices. The  pulsatile device that  has been
              data  from INTERMACS have  shown  that  this strate-  used since 1960s  is  the intra-aortic balloon pump
              gy  yields  80% one-year  and 48% 5-year  survival  in   that  primarily  functions  to augment  the diastolic
              the current era, starting to approach the survival af-  pressure  and, as  a result,  increase  coronary  per-
              ter heart transplantation in individuals older than 60   fusion. The ventricular  unloading aspect of the  in-
              years of age (87% one-year and 69% 5-year survival).   tra-aortic balloon pump (counter pulsation) relies on
              Finally,  theresults from the recently  completed Risk   an intact  ventricular-vascular  coupling  and may be
              Assessment  and Comparative Effectivenessof  Left   diminished in patients with sicker left ventricles. The
              Ventricular Assist Device and Medical Management   third part of the equation (i.e. circulatory support) re-
              in Ambulatory HeartFailure Patients (ROADMAP) tri-  lies on the augmented mean arterial pressure that is
              al  have shown that  in carefully  selected  profile  4-7   driven primarily by the augmented diastolic pressure.
              patients, the 1 and 2 year survival were greater than   Its usefulness is limited to patients in the early shock
              continuing optimal medical therapy (80% vs. 63% for   phase or in patients with active ischemia or ischemic
              one-year,  and  70%  vs. 43%  for two year  survival in   ventricular arrhythmias.The  continuous  flow  devices
              theventricular assist device and optimal medical ther-  can be further divided into axial or centrifugal flowde-
              apy groups, respectively).                         vices. The  axial  flow  pumps  that  currently exist  are
                                                                 the Impella axial flow catheters(2.5 L, CP and 5 L) that
              Acute (Temporary) Mechanical Circulatory           use a rotodynamic  pump and work  by  taking blood
              Support Devices                                    from the left ventricle and directly ejecting it into the
                                                                 aorta. Axial flowdevices will effectively increase mean
              These devices are used primarily in patients needing   arterial pressure and directly unload the leftventricle,
              high-risk  percutaneous coronary interventions,  or  in   thereby reducing ventricular pressure. As a result of
              post-cardiotomy  failure  to wean from the cardiopul-  the increased  meanaortic pressure  and lower  ven-
              monarybypass, or in cardiogenic shock. Cardiogenic   tricular pressure, the transmyocardial perfusion gra-
              shock occurs secondary to acute left or right ventric-  dient changes and  coronary perfusion  will increase.
              ular systolic dysfunction, acute (on chronic) aortic or   The centrifugal flow pumps  are  extracorporeal  and
              mitral valvular disease, and vasodilator abnormalities   include the TandemHeartdevice and veno-arterial ex-
              in patients  with  acute  myocardial infarction,  out-of   tracorporeal  membrane oxygenation (VA ECMO).  In
              hospital cardiacarrest, and  worsening  chronic  heart   the  Tandem  Heart configuration  for left ventricular
              failure.  In clinical practice, patients with cardiogenic   support,  blood is  taken out  of the left atrium  (via  a
              shock represent  a spectrum of  disease  that  can  be   trans-septal catheter) and delivered into the systemic
              classified  as early  shock,shock,  and severe  shock,   circulationto the iliac artery. In the VA ECMO configu-
              depending on the level of blood pressure, heart rate,   ration, blood is taken from the right atrium, oxygenat-
              intracardiac  filling pressures, cardiac  output,  tissue   ed, and delivered to the iliac artery into the systemic
              perfusion  (lactate,  urine output)  and  need for vaso-  circulation.The  hemodynamic  effect between these
              active medications. Potential  benefits of temporary   two devices  is very different.  The  Tandem Heart will
              mechanical  circulatory support devices in this set-  effectively address all three components of the equa-
              ting include the ability to provide circulatory support   tion byunloading the left  ventricle, by  reducing  left
              (thereby maintaining  vital  organ perfusion  and  pre-  atrial volume (reducing left ventricular  preload), and
              venting systemic shock syndrome); provide  ventric-  by increasing mean arterial pressure, which leads to
              ular unloading (left,  right, biventricular)  in order  to
                                                                 increase in the coronary perfusion pressure. The VA

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