ISHLT Guidelines
The 2013 International Society for Heart and Lung Transplantation Guidelines for mechanical circulatory support: Executive summary

https://doi.org/10.1016/j.healun.2012.09.013Get rights and content

Institutional Affiliations

Co-chairs

Feldman D: Minneapolis Heart Institute, Minneapolis, Minnesota, Georgia Institute of Technology and Morehouse School of Medicine; Pamboukian SV: University of Alabama at Birmingham, Birmingham, Alabama; Teuteberg JJ: University of Pittsburgh, Pittsburgh, Pennsylvania

Task force chairs

Birks E: University of Louisville, Louisville, Kentucky; Lietz K: Loyola University, Chicago, Maywood, Illinois; Moore SA: Massachusetts General Hospital, Boston, Massachusetts; Morgan JA: Henry Ford Hospital, Detroit, Michigan

Contributing writers

Arabia F: Mayo Clinic Arizona, Phoenix, Arizona; Bauman ME: University of Alberta, Alberta, Canada; Buchholz HW: University of Alberta, Stollery Children’s Hospital and Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada; Deng M: University of California at Los Angeles, Los Angeles, California; Dickstein ML: Columbia University, New York, New York; El-Banayosy A: Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania; Elliot T: Inova Fairfax, Falls Church, Virginia; Goldstein DJ: Montefiore Medical Center, New York, New York; Grady KL: Northwestern University, Chicago, Illinois; Jones K: Alfred Hospital, Melbourne, Australia; Hryniewicz K: Minneapolis Heart Institute, Minneapolis, Minnesota; John R: University of Minnesota, Minneapolis, Minnesota; Kaan A: St. Paul’s Hospital, Vancouver, British Columbia, Canada; Kusne S: Mayo Clinic Arizona, Phoenix, Arizona; Loebe M: Methodist Hospital, Houston, Texas; Massicotte P: University of Alberta, Stollery Children’s Hospital, Edmonton, Alberta, Canada; Moazami N: Minneapolis Heart Institute, Minneapolis, Minnesota; Mohacsi P: University Hospital, Bern, Switzerland; Mooney M: Sentara Norfolk, Virginia Beach, Virginia; Nelson T: Mayo Clinic Arizona, Phoenix, Arizona; Pagani F: University of Michigan, Ann Arbor, Michigan; Perry W: Integris Baptist Health Care, Oklahoma City, Oklahoma; Potapov EV: Deutsches Herzzentrum Berlin, Berlin, Germany; Rame JE: University of Pennsylvania, Philadelphia, Pennsylvania; Russell SD: Johns Hopkins, Baltimore, Maryland; Sorensen EN: University of Maryland, Baltimore, Maryland; Sun B: Minneapolis Heart Institute, Minneapolis, Minnesota; Strueber M: Hannover Medical School, Hanover, Germany

Independent reviewers

Mangi AA: Yale University School of Medicine, New Haven, Connecticut; Petty MG: University of Minnesota Medical Center, Fairview, Minneapolis, Minnesota; Rogers J: Duke University Medical Center, Durham, North Carolina

Section snippets

Task Force 1: Selection of candidates for MCS and risk management prior to implantation for fixed comorbidities

Chair: Katherine Lietz, MD

Contributing Writers: Mario Deng, MD; David Feldman, MD, PhD; Annemarie Kaan, MCN, RN; Salpy V. Pamboukian, MD, MSPH; J. Eduardo Rame, MD, MPhil; Jeffrey J. Teuteberg, MD

Reviewers: Emma Birks, MD; Francis Pagani, MD; Michael G. Petty, PhD, RN; Abeel A. Mangi, MD

Recommendations for the evaluation process of MCS candidates:1–7

Class I:

  • 1.

    All patients should have any reversible causes of heart failure addressed prior to consideration for MCS.

     Level of evidence: A.

  • 2.

    All patients referred for MCS should have their transplant candidacy assessed prior to implant.

     Level of evidence: A.

Recommendations for the clinical classification of MCS candidates:7

Class I:

  • 1.

    All patients being considered for MCS should have their New York Heart Association functional class assessed.

     Level of evidence: C.

  • 2.

    All patients being assessed for MCS should have their Interagency Registry for Mechanically Assisted Support

Recommendations for patients with coronary artery disease:31,32

Class IIa:

  • 1.

    Patients being considered for MCS who have a history of coronary artery bypass grafting should have a chest computed tomography (CT) scan to provide the location and course of the bypass grafts to guide the surgical approach.

     Level of evidence: C.

Recommendations for patients with acute myocardial infarction:

Class IIb:

  • 1.

    If possible, permanent MCS should be delayed in the setting of an acute infarct involving the left ventricular (LV) apex.

     Level of evidence: C.

Recommendations for the evaluation of MCS candidates with congenital heart disease:

Class I:

  • 1.

    All patients with congenital heart disease should have recent imaging to fully

Task Force 2: Patient optimization, consent, and appropriate timing for MCS: Modifiable risk management prior to implantation

Co-chairs: Emma Birks, MD; David Feldman, MD, PhD

Contributing Writers: Katarzyna Hryniewicz, MD; Nader Moazami, MD; William Perry, RN; J. Eduardo Rame, MD; Benjamin Sun, MD; Jeffrey J. Teuteberg, MD

Independent Reviewer: Francis Pagani, MD

Task Force 3: Intraoperative and immediate post-operative management

Chair: Jeffrey A. Morgan, MD

Contributing Writers: Marc L. Dickstein, MD; Aly El-Banayosy, MD; Daniel J. Goldstein, MD; Matthias Loebe, MD, PhD; Erik N. Sorensen, PhD; Martin Strueber, MD

Independent Reviewer: Francis Pagani, MD

Recommendations for managing anesthesia issues:143–157

Class I:

  • 1.

    Patients undergoing MCSD placement should have insertion of a large-bore intravenous line, arterial line, and pulmonary artery catheter to allow for continuous monitoring and intravascular access.

     Level of evidence: B

  • 2.

    Cardiac anesthesia should be performed by those familiar with the clinical issues associated with MCSD placement, including considerations at the time of induction, during surgery, during separation from cardiopulmonary bypass, and at the time the MCSD is actuated.

     Level of

Topic 2: Implantation techniques

Implant techniques vary with pump type; readers are referred to the on-line document for a full discussion of these issues (available on the JHLTonline.org Web site).

Topic 3: Special considerations for VAD implantation

These considerations may vary with pump type; readers are referred to the on-line document for a full discussion of these issues (available on the JHLTonline.org Web site).

Topic 4: Explantation techniques: Explantation of LVADs for heart transplantation

Explant techniques vary with pump type; readers are referred to the on-line document for a full discussion of these issues (available on the JHLTonline.org Web site).

Topic 5: Early post-operative management: Hemodynamic management

Recommendations for early post-operative hemodynamic management are presented in Table 1.88, 158, 159 Figure 1 provides recommendations for low pump output treatment. Early post-operative anti-coagulation management recommendations are presented in Table 2, Table 3, Table 4.43, 87, 160, 161, 162, 163, 164, 165, 166, 167 Table 5 provides guidelines for removal of invasive lines and drains in a stable post-operative MCS patient. Ventilation parameters for the early post-operative period are

Task Force 4: Inpatient management of patients with MCSDs

Co-chairs: Stephanie A. Moore, MD; Salpy V. Pamboukian MD, MSPH; Jeffrey J. Teuteberg, MD

Contributing writers: Francisco Arabia, MD; Mary E. Bauman, MScN, NP; Hoger W. Buchholz, MD; Ranjit John, MD; David Feldman, MD, PhD; Kathleen L. Grady, PhD, APN; Kylie Jones, RN; Shimon Kusne, MD; M. Patricia Massicotte, MHSc, MD; Martha Mooney, MD; Thomas Nelson, MD; Francis Pagani, MD

Task Force 5: Outpatient management of the MCSD recipient

Chair: Salpy V. Pamboukian, MD, MSPH

Contributing Writers: Tonya Elliot, RN, MSN; Paul Mogacsi, MD; Evgenij V. Potapov, MD; Stuart D. Russell, MD; Jeffrey J. Teuteberg, MD

Independent Reviewers: Joseph Rogers, MD; Francis Pagani, MD

Recommendations for evaluation of safety of the home environment:87,216,266,267

Class I:

  • 1.

    An uninterrupted supply of electricity to continuously power the MCSD must be ensured. Outlets must be grounded, and the use of electrical extension cords or outlets with a switch should be avoided. The local electrical company must be notified of the customer’s need for electricity to power life-sustaining equipment in the home. Patients are advised to develop an emergency plan in the event electricity becomes unavailable in the home.

     Level of evidence: C.

  • 2.

    Patients should have a working

Recommendations for the multidisciplinary approach to follow-up care:

Class I:

  • 1.

    Management of the patient with an MCSD should be performed by a multidisciplinary team that includes cardiovascular surgeons, advanced heart failure cardiologists, and specialized MCS coordinators. Other health care providers may collaborate with the primary MCS team when additional expertise is required.

     Level of evidence: C.

Recommendations for frequency of visits:270

Class I:

  • 1.

    MCS patients should be seen in clinic regularly, the frequency of which is dictated by their clinical stability.

     Level of evidence: B.

  • 2.

    MCS patients should

Recommendations for exercise and cardiac rehabilitation:296–308

Class I:

  • 1.

    All patients who are able should be enrolled in cardiac rehabilitation after surgical placement of an MCSD.

     Level of evidence: C.

Recommendations for anti-coagulation:86,160,309

Class I:

  • 1.

    Patients with MCSD should receive anti-coagulation with warfarin to maintain an INR within a range as specified by each device manufacturer (Table 9).

     Level of evidence: B.

Recommendations for anti-platelet therapy:237,238,310–320

Class I:

  • 1.

    Chronic anti-platelet therapy with aspirin (81–325 mg daily) may be used in addition to warfarin in patients with MCSD.

     Level of evidence: C.

  • 2.

    Anti-platelet therapy beyond aspirin may be added to warfarin according to the recommendations of specific device manufacturers.

     Level of evidence: C.

Class IIb:

  • 1.

    Assessment of

Recommendations for ICD placement:3,31,330

Class I:

  • 1.

    For patients who have an ICD prior to MCS, the ICD should be reactivated in the post-operative setting.

     Level of evidence: A.

Class IIa:

  • 1.

    Routine placement of an ICD should be considered for patients who did not have an ICD prior to MCS.

     Level of evidence: B.

  • 2.

    Inactivation of the ICD should be considered in patients with biventricular assist devices who are in persistent VT/VF or who have frequent sustained runs of VT despite optimal anti-arrhythmic therapy.

     Level of evidence: C.

Recommendations for management of atrial fibrillation and flutter:331

Class I:

  • 1.

Recommendations for psychologic and psychiatric issues:55,65,67,68,228,334–346

Class I:

  • 1.

    Patients being considered for MCSD should have a detailed psychosocial evaluation.

     Level of evidence: C.

  • 2.

    A formal consultation with a psychiatrist should be obtained for those with concerns for psychiatric illness. Appropriate pharmacologic and psychologic therapy should be initiated as needed. Counseling may need to be extended to include family members as well.

     Level of evidence: C.

Recommendations for emergency procedures with device malfunction or failures:

Class I:

  • 1.

    The patient and their caregivers should be trained to recognize MCSD alarms and troubleshoot emergencies prior to hospital discharge. This training should be delivered using both written materials and visual demonstrations, and emergency response skills should be tested before the patient and caregiver leave the hospital.

     Level of evidence: C.

  • 2.

    Ongoing refreshers should be provided to patients and caregivers at outpatient visits to ensure they remain competent in emergency procedures.

     Level

Recommendations for end of life issues:4,58,347–350

Class I:

  • 1.

    Consultation with palliative medicine should be considered prior to MCSD implantation to facilitate discussion of end of life issues and establish an advance directive or living will, particularly when implanted as DT.

     Level of evidence: C.

  • 2.

    In situations when there is no consensus about discontinuing MCSD support, consideration may be given to consulting with the hospital ethicist or ethics board.

     Level of evidence: C.

Disclosure statement

The following contributing writers and reviewers have the following disclosures:

NameCommercial interestRelationship
David FeldmanDuraheart (Terumo)Research/Principal Investigator
Mario DengXDc, Inc.Consultant, research grant
Emma BirksThoratecHonoraria
Francis PaganiHeartware/NHLBIResearch/Principal Investigator
Michael G. PettyThoratecResearch grant/honoraria
Nader MoazamiThoratecConsultant
TerumoConsultant
Benjamin SunThoratecConsultant
Sunshine HeartConsultant
Aly El-BanayosyThoratecSpeaker
Maquet

References (350)

  • L.H. Lund et al.

    Validation of peak exercise oxygen consumption and the Heart Failure Survival Score for serial risk stratification in advanced heart failure

    Am J Cardiol

    (2005)
  • M.R. Mehra et al.

    Listing criteria for heart transplantation: International Society for Heart and Lung Transplantation guidelines for the care of cardiac transplant candidates—2006

    J Heart Lung Transplant

    (2006)
  • R.E. Hershberger et al.

    Care processes and clinical outcomes of continuous outpatient support with inotropes (COSI) in patients with refractory endstage heart failure

    J Card Fail

    (2003)
  • M.J. Krell et al.

    Intermittent, ambulatory dobutamine infusions in patients with severe congestive heart failure

    Am Heart J

    (1986)
  • V. Rao et al.

    Revised screening scale to predict survival after insertion of a left ventricular assist device

    J Thorac Cardiovasc Surg

    (2003)
  • J.M. Schaffer et al.

    Evaluation of risk indices in continuous-flow left ventricular assist device patients

    Ann Thorac Surg

    (2009)
  • J. Teuteberg et al.

    Application of the destination therapy risk score to HeartMate II clinical trial data [abstract] [manuscript in press, JACC]

    J Heart Lung Transplant

    (2011)
  • A.J. Boyle et al.

    Clinical outcomes for continuous-flow left ventricular assist device patients stratified by pre-operative INTERMACS classification

    J Heart Lung Transplant

    (2011)
  • J. Cowger et al.

    The HeartMate II risk score: Predicting survival in candidates for left ventricular assist device support [abstract]

    J Heart Lung Transplant

    (2011)
  • F.D. Pagani et al.

    Extended mechanical circulatory support with a continuous-flow rotary left ventricular assist device

    J Am Coll Cardiol

    (2009)
  • M. Strueber et al.

    Multicenter evaluation of an intrapericardial left ventricular assist system

    J Am Coll Cardiol

    (2011)
  • P. Johnsson et al.

    Cardiopulmonary perfusion and cerebral blood flow in bilateral carotid artery disease

    Ann Thorac Surg

    (1991)
  • H.L. Lazar et al.

    Coronary artery bypass grafting in patients with cerebrovascular disease

    Ann Thorac Surg

    (1998)
  • N. Uriel et al.

    Fixed pulmonary hypertension and mechanical support: an unclear opportunity

    J Heart Lung Transplant

    (2011)
  • T.S. Kato 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

    (2012)
  • Y. Wadia et al.

    Pathophysiology of hepatic dysfunction and intrahepatic cholestasis in heart failure and after left ventricular assist device support

    J Heart Lung Transplant

    (2005)
  • M.C. Morel-Kopp et al.

    Whole blood impedance aggregometry detects heparin-induced thrombocytopenia antibodies

    Thromb Res

    (2010)
  • T.E. Warkentin et al.

    Heparin-induced thrombocytopenia in patients with ventricular assist devices: are new prevention strategies required?

    Ann Thorac Surg

    (2009)
  • M.J. Zucker et al.

    Cardiac transplantation and/or mechanical circulatory support device placement using heparin anti-coagulation in the presence of acute heparin-induced thrombocytopenia

    J Heart Lung Transplant

    (2010)
  • J. Butler et al.

    Diabetes and outcomes after left ventricular assist device placement

    J Card Fail

    (2005)
  • V.K. Topkara et al.

    Effect of diabetes on short- and long-term outcomes after left ventricular assist device implantation

    J Heart Lung Transplant

    (2005)
  • D.B. Sims et al.

    A successful pregnancy during mechanical circulatory device support

    J Heart Lung Transplant

    (2011)
  • W.L. Holman et al.

    Predictors of death and transplant in patients with a mechanical circulatory support device: a multi-institutional study

    J Heart Lung Transplant

    (2009)
  • R.M. Adamson et al.

    Clinical strategies and outcomes in advanced heart failure patients older than 70 years of age receiving the HeartMate II left ventricular assist device: a community hospital experience

    J Am Coll Cardiol

    (2011)
  • S. Cupples et al.

    Report of the Psychosocial Outcomes Workgroup of the Nursing and Social Sciences Council of the International Society for Heart and Lung Transplantation: present status of research on psychosocial outcomes in cardiothoracic transplantation: review and recommendations for the field

    J Heart Lung Transplant

    (2006)
  • J.L. Levenson et al.

    Psychosocial evaluation of organ transplant candidates. A comparative survey of process, criteria, and outcomes in heart, liver, and kidney transplantation

    Psychosomatics

    (1993)
  • B. Bunzel et al.

    Posttraumatic stress disorder after implantation of a mechanical assist device followed by heart transplantation: evaluation of patients and partners

    Transplant Proc

    (2005)
  • B. Bunzel et al.

    Mechanical circulatory support as a bridge to heart transplantation: what remains? Long-term emotional sequelae in patients and spouses

    J Heart Lung Transplant

    (2007)
  • F. Zahr et al.

    Obese patients and mechanical circulatory support: weight loss, adverse events, and outcomes

    Ann Thorac Surg

    (2011)
  • R.J. Brewer et al.

    Extremes of body mass index do not impact mid-term survival after continuous-flow left ventricular assist device implantation

    J Heart Lung Transplant

    (2012)
  • S.A. Hunt et al.

    Focused update incorporated into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Heart Failure in Adults A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines developed in collaboration with the International Society for Heart and Lung Transplantation

    J Am Coll Cardiol

    (2009)
  • S. Brush et al.

    End-of-life decision making and implementation in recipients of a destination left ventricular assist device

    J Heart Lung Transplant

    (2010)
  • S.E. Sandner et al.

    Renal function and outcome after continuous flow left ventricular assist device implantation

    Ann Thorac Surg

    (2009)
  • J. Butler et al.

    Relationship between renal function and left ventricular assist device use

    Ann Thorac Surg

    (2006)
  • V.K. Topkara et al.

    Predictors and outcomes of continuous veno-venous hemodialysis use after implantation of a left ventricular assist device

    J Heart Lung Transplant

    (2006)
  • C. Ootaki et al.

    Reduced pulsatility induces periarteritis in kidney: role of the local renin-angiotensin system

    J Thorac Cardiovasc Surg

    (2008)
  • S.E. Sandner et al.

    Renal function after implantation of continuous versus pulsatile flow left ventricular assist devices

    J Heart Lung Transplant

    (2008)
  • B. Radovancevic et al.

    End-organ function in patients on long-term circulatory support with continuous- or pulsatile-flow assist devices

    J Heart Lung Transplant

    (2007)
  • G.V. Letsou et al.

    Continuous axial-flow left ventricular assist device (Jarvik 2000) maintains kidney and liver perfusion for up to 6 months

    Ann Thorac Surg

    (2003)
  • M. Singh et al.

    Impact of renal function before mechanical circulatory support on posttransplant renal outcomes

    Ann Thorac Surg

    (2011)
  • Cited by (0)

    *

    Co-first authors contributed equally and are listed in alphabetical order.

    View full text