ASAIO Journal 2014

Clinical Cardiovascular

Comparison of Biventricular and Left Ventricular Assist Devices for the Management of Severe Right Ventricular Dysfunction in Patients with End-Stage Heart Failure Nadia Aissaoui,*† Michiel Morshuis,* Lech Paluszkiewicz,* Volker Lauenroth,* Jochen Börgermann,* and Jan Gummert*

V

Right ventricular failure (RVF) exposes ventricular assist device (VAD) recipients to a high risk of death, but its management has not yet been standardized. We report three separate management strategies used for VAD recipients that present with RVF at a single center: 1) Thoratec paracorporeal biventricular VAD implantation, 2) left ventricular assist device (LVAD) implantation with temporary CentriMag right ventricular assist device (RVAD), and 3) LVAD combined with inotropic therapy. We retrospectively compared the preoperative data, the clinical outcomes, and the rates of adverse events in 84 biventricular assist device (BiVAD) recipients and 89 LVAD recipients presenting with postoperative RVF (57 were treated with a temporary RVAD and 32 were managed medically). Risk factors for death were analyzed. The BiVAD recipients were significantly younger, more critically ill at the time of device implantation, and required extracorporeal membrane oxygenation, an intraaortic balloon pump, mechanical ventilation, inotropes, or cardiopulmonary resuscitation significantly more often (at the time of device implant) than the LVAD recipients with RVF. The 6 month mortality was comparable in the two groups: 44 BiVAD patients (52%) and 38 LVAD patients (43%). Age, previous cardiac surgery, low platelet count, increased creatinine levels, the use of preoperative mechanical ventilation, and the need for a temporary RVAD were associated with 6 month mortality. The occurrence of RVF at the time of device implantation is a severe situation; it is associated with excess mortality, even if it is managed using a BiVAD or a LVAD with a temporary RVAD, probably because of the high preoperative risk profiles of the patients. In all cases, RVF must be managed quickly. ASAIO Journal 2014; 60:400–406.

entricular assist devices have become a life-saving therapeutic option for patients suffering from end-stage heart failure (HF).1,2 The 1 year survival after left ventricular assist device (LVAD) implantation is similar to that after cardiac transplantation but remains limited by early morbidity and mortality because of multiple organ failure, postoperative hemorrhages, pulmonary complications, thromboembolic events, and right ventricular (RV) failure.3,4 There is up to a 50% incidence of right ventricular failure (RVF) after LVAD implantation; this is responsible for a perioperative mortality and morbidity rate between 19% and 43%5,6 and end-organ dysfunction associated with prolonged intensive care and hospitalization.7,8 The prediction and management of postoperative RV dysfunction is complicated as there are many factors that can contribute to RVF after LVAD implantation.1,5,6 The use of biventricular mechanical support for end-stage congestive HF remains controversial, despite its effectiveness in the treatment of severe RVF, as patients who require prolonged support with biventricular assist devices (BiVADs) have a lower survival than recipients of LVADs.9–11 The 6 month mortality after BiVAD implantation may reach 44% but can be 24% after LVAD implantation.10,11 BiVAD recipients also suffer higher rates of major adverse events such as thromboembolisms, device infections, and mechanical complications; these can decrease their survival after cardiac transplantation.11 It has been argued that early BiVAD implantation might markedly increase survival,9 but this is disputed.8,12 The value of a temporary CentriMag right ventricular assist device (RVAD) (Levitronix LCC, Waltham, MA) implant to manage postoperative RVF after LVAD implantation has been suggested.13,14 However, reports of postoperative RVF management by temporary placement of an RVAD after LVAD implantation are limited to isolated cases or small group sample sizes. RVF after LVAD implantation can be managed with pulmonary vasodilators (such as nitroprusside, nitric oxide, and iloprost) and inotropes (such as milrinone, dobutamine, and epinephrine).7 However, the consequences of prolonged inotropic support on a dysfunctional RV, in the presence of a LVAD, are poorly known and medical therapy alone may be insufficient. No study has compared RVF management strategies during the implementation of mechanical circulatory support (MCS). We report three strategies for managing ventricular assist device (VAD) recipients suffering from RVF: 1) Thoratec

Key Words:  end-stage heart failure, right ventricular failure, LVAD, BiVAD, mechanical circulatory support From the *Heart & Diabetes Center, North Rhine-Westphalia, Bad Oeynhausen, Germany; and †Hôpital Européen Georges Pompidou, APHP, Paris, France. Submitted for consideration August 2013; accepted for publication in revised form March 2014. Disclosure: The authors have no conflicts of interest to report. Correspondence: Nadia Aissaoui, MD, Hôpital Européen Georges Pompidou, 20 rue Leblanc, 75015 Paris, France. Email: [email protected]. Copyright © 2014 by the American Society for Artificial Internal Organs DOI: 10.1097/MAT.0000000000000082

400



401

RIGHT VENTRICULAR FAILURE IN VAD RECIPIENTS

paracorporeal BiVAD (Thoratec Corp., Pleasanton, CA) implantation (or HeartWare [HeartWare International Inc., Miami Lakes, FL] BiVAD), 2) LVAD implantation with temporary CentriMag system implantation, and 3) LVAD implantation combined with the administration of inotropes and nitric oxide. We compared the clinical outcomes and adverse events in BiVAD recipients and LVAD recipients with postoperative RVF (LVAD recipients were treated medically or with a temporary RVAD). Methods Data collection.  Demographic and clinical data (including all laboratory tests, adverse events, device-related complications and malfunctions, and long-term outcomes) were systematically and prospectively entered into a database. The entries were completed by study coordinators, bioengineers, and physicians at the time of VAD implantation or listing for transplantation. This study complies with the Declaration of Helsinki; our database was designed for clinical purpose and research protocols approved by the Ethics Committee for the Protection of Human Subjects of our institution. This observational study did not modify diagnostic tests or therapeutic interventions and so informed consent was not sought from the patients. Study participants.  Data were collected prospectively, and analyzed retrospectively, from all patients who underwent VAD implantation between January 2000 and May 2011, at the Clinic for Thoracic and Cardiovascular Surgery of Bad Oeynhausen, Germany. Mechanical circulatory support was required for 723 patients. The 151 patients who received a total artificial heart (TAH) were excluded from the analysis. Since 2001 the TAH is available in our center. Total artificial heart therapy was suitable for patients with BiVAD failure, no chance on recovery with a body surface area >1.7 m2. Our strategy changed over the years; the decision was taken by the implanting surgeon. If the patient suffered from severe biventricular failure, LVAD or LVAD with temporary RVAD was not an option, our first choice was a Thoratec paracorporeal ventricular assist device (PVAD) BiVAD or in rare cases a HeartWare BiVAD. In case of severe damage of the ventricle because of myocardial infarction, in case of onset of multi-organ failure, TAH was the only option. Total artificial heart could be considered if a mechanical valve was in place, thrombus formation in the left ventricle, redo cases with severe adhesions, or hypertrophic cardiomyopathy. The data of TAH are available on supplementary material online (Tables 1 and 2). Of the remaining 572 patients, 84 were Thoratec paracorporeal PVAD and HeartWare BiVAD recipients and 488 were LVAD recipients. The BiVAD group consisted of 69 patients for whom the decision to implant had been made preoperatively and 15 LVAD recipients who could not be weaned from cardiopulmonary bypass. The LVAD group consisted of 399 patients without RVF and 89 patients with RVF who required a temporary RVAD implant or medical therapy (Figure 1). Definition and management of right ventricular failure.   Right ventricular failure has been defined as an unplanned insertion of an RVAD or the use of an intravenous inotrope for longer than 14 days postoperatively.3,10 In our center, the decision to implant an RVAD was made by a cardiac surgeon in consultation with a cardiologist specialized in HF. This was based on multiple factors including overall clinical status,

Table 1.  Baseline Characteristics of the Treatment Groups Study Groups BiVAD (N = 84)

LVAD with RVF (N = 89)

Age (years) 49.6 ± 13.8 54.0 ± 13.9 Men 67 (80) 74 (83) 1.88 ± 0.21 1.89 ± 0.21 Body surface area (m2) Cardiomyopathy  Ischemic 38 (45) 48 (54)   Idiopathic, dilated 32 (36) 31 (37) Myocarditis 10 (12) 4 (4) Other heart disease 4 (5) 5 (6) History of   Cardiac surgery 31 (37) 35 (39)   Myocardial infarction 11 (13) 4 (4) Reason for treatment   Bridge to 71 (85) 66 (74) transplantation   Bridge to recovery 2 (2) 1 (1)   Destination therapy 7 (8) 19 (21)   Bridge to decision 4 (5) 3 (3) Left ventricular   End diastolic 66.6 ± 13.6 68.9 ± 11.1 diameter (mm)   Ejection fraction (%) 23.4 ± 12.1 21.3 ± 7.3 2.0 ± 0.4 2.1 ± 0.5 Cardiac index (L/min/m2) Central venous 15.8 ± 5.8 11.1 ± 6.2 pressure (mm Hg) Mean pulmonary arterial 33.3 ± 8.78 32.4 ± 10.8 pressure (mm Hg) 255.4 ± 148.4 298.8 ± 239.7 Pulmonary vascular resistance 5 (dynes-sec/cm ) 1,164.1 ± 550.3 1,191.5 ± 414.6 Systemic vascular resistance (dynes-sec/cm5) Pulmonary capillary 22.7 ± 7.6 20.8 ± 8.1 wedge pressure (mm Hg)

p 0.011 0.39 0.95 0.55 0.33 0.45 0.80 0.75 0.43 0.78 0.88 0.63 0.69 0.58 0.35 0.42 0.005 0.54 0.54 0.23 0.29

Values are means ± standard deviation or numbers (%) of observations. BiVAD, biventricular assist device; LVAD, left ventricular assist device; RVF, right ventricular failure.

patient size, transplant eligibility, device availability, expected duration of support, and patient preference. The planned BiVAD were implanted in case of severe preoperative impaired RV function (assessed by hemodynamic and echo parameters) in patients with impaired general conditions (multiorgan failure). The preoperative risk profile was very important in the selection. We used the Michigan score. In others cases, LVAD was planned. In planned LVAD patients, when central venous pressure increased (>15 mm Hg) with decreased left atrial pressure (

Comparison of biventricular and left ventricular assist devices for the management of severe right ventricular dysfunction in patients with end-stage heart failure.

Right ventricular failure (RVF) exposes ventricular assist device (VAD) recipients to a high risk of death, but its management has not yet been standa...
384KB Sizes 0 Downloads 3 Views