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Timing of Temporary Right Ventricular Assist Device Insertion for Severe Right Heart Failure After Left Ventricular Assist Device Implantation

Takeda, Koji*; Naka, Yoshifumi*; Yang, Jonathan A.*; Uriel, Nir; Colombo, Paolo C.; Jorde, Ulrich P.; Takayama, Hiroo*

doi: 10.1097/MAT.0b013e3182a816d1
Adult Circulatory Support

Data on how the timing of a temporary right ventricular assist device (RVAD) insertion affects outcome are limited in patients receiving left ventricular assist device (LVAD). Of the 282 patients who underwent LVAD placement between January 2000 and November 2010, 40 (14%) required concomitant (n = 26) or delayed (n = 14) RVAD insertion as temporary support. We analyzed early and 1-year outcomes. Preoperative variables were similar in the concomitant and delayed RVAD groups. The hospital mortality rate was approximately 50% in both groups (p = 0.82). The 1-year actuarial survival was similar in both groups (p = 0.42). Patients who required RVAD support had higher in-hospital mortality and worse 1-year survival rates than those who received LVAD only (48% vs. 9.5%, p < 0.0001; 40% vs. 82%, p < 0.0001). Multivariate logistic regression analysis indicated RVAD use as a significant risk factor for 1-year mortality (odds ratio, 18; p = 0.0003; 95% confidence interval, 3.765–86.74). Timing of temporary RVAD insertion did not affect overall survival. Necessity of RVAD support is associated with significantly worse early and late mortality at any rate. The decision to place the RVAD can be made once it is clinically necessary.

From the *Department of Surgery, Division of Cardiothoracic Surgery, Columbia University Medical Center, New York, NY; and Department of Medicine, Division of Cardiology, Columbia University Medical Center, New York, NY.

Submitted for consideration April 2013; accepted for publication in revised form July 2013.

Disclosure: Ulrich P. Jorde and Yoshifumi Naka have received consulting fees from Thoratec Corp. The remaining authors have no conflicts of interest to disclose.

Reprint Requests: Hiroo Takayama, MD, PhD, Columbia University, 177 Fort Washington Avenue, New York, NY 10032. Email:

Right ventricular (RV) failure is a serious complication associated with significant perioperative mortality and morbidity in patients receiving a left ventricular assist device (LVAD).1,2 Approximately 20% patients develop some form of RV failure after LVAD placement.2 Studies that have attempted to ascertain the preoperative predictors of RV failure have identified various factors.2–6 A planned placement of a durable-type biventricular assist device (BiVAD) might result in superior outcomes over a delayed placement for patients having such risk factors.6 However, because many factors contribute to RV function after LVAD, RV failure often becomes clinically obvious after LVAD support is initiated. Moreover, the outcome of BiVAD remains poorer than those of isolated LVAD.7

Recently, some studies reported the usefulness of temporary right ventricular assist device (RVAD) to avoid implantation of durable-type BiVAD.8–14 This strategy might be useful to identify patients who require only a few days or weeks of RV support. In either case, the timely placement of RVAD would be necessary to establish an adequate end-organ support without a delay. However, the data on how the timing of temporary RVAD placement affects the outcomes remain limited to a small series of patients. In this study, we review our larger experience of temporary RVAD after LVAD placement.

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The Institutional Review Board approved this study. We retrospectively reviewed our experience at the Columbia Presbyterian Medical Center from January 2000 to November 2010. During this period, a total of 282 patients with end-stage heart failure underwent implantation of a HeartMate LVAD (Thoratec, Pleasanton, CA). Of these, 40 (14%) developed severe postoperative RV failure and required insertion of a temporary RVAD. The decision of RVAD insertion in each patient was made on the discretion of a surgeon and a heart failure cardiologist. The definition of severe RV failure and the indications for implantation of an RVAD were according to those described elsewhere.15

Based on the timing of RVAD insertion, the RVAD group was divided into two subgroups: (1) concomitant RVAD or (2) delayed RVAD. The concomitant RVAD group included patients who required the RVAD support concurrently with the LVAD. Most of those patients could not be weaned from cardiopulmonary bypass after the LVAD insertion. The delayed group was defined as patients who received RVAD support at any point after the day of LVAD implantation.

Preoperative and postoperative variables that correlate with survival were collected for each patient. One-year overall survival was the primary endpoint that was compared between the groups.

In patients who received the RVAD, we specifically collected early postoperative data, including blood urea nitrogen (BUN), creatinine, total bilirubin, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) levels to assess end-organ recovery after RVAD insertion. Values were measured before RVAD implantation and on postoperative days 1 and 3.

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During this study period, for LVAD support, HeartMate I was used in 168 (60%) and HeartMate II in 114 (40%). For RVAD support, we used Thoratec PVAD (Thoratec, Pleasanton, CA) in two patients (5%), Abiomed AB 5000 (Abiomed, Danvers, MA) in 25 (63%), and CentriMag (Thoratec, Pleasanton, CA) in 13 (32%). The RVAD was established with the right atrium and pulmonary artery cannulation in all cases.

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Statistical Analysis

Data were represented as frequency distributions and percentages. Continuous variables were expressed as a mean ± standard deviation and were compared using samples t-tests. Categorical variables were compared by means of χ2 tests. For all analyses, p < 0.05 was considered statistically significant. Kaplan–Meier analysis was used to calculate survival along with a log-rank p value when comparing groups. Stepwise logistic regression analysis was performed to identify the risk factors of the need for RVAD and 1-year mortality. Factors with a value of p < 0.1 in the univariate analyses were entered into the stepwise logistic regression model. All data were analyzed using SPSS 11.0 (SPSS Inc, Chicago, IL).

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Baseline Patient Characteristics

Baseline characteristics are outlined in Table 1. A high proportion of women required RVAD support, and they were more likely to have higher central venous pressure (CVP), worse hepatic function, and deteriorating other biomarker levels, including white blood cell count, hematocrit, and international normalized ratio. Using multivariate stepwise logistic regression analysis, preoperative CVP (odds ratio [OR], 1.075; 95% confidence interval [CI], 1.016–1.138; p = 0.013) was a significant predictor for RVAD insertion.

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Early and Late Outcomes According to the Necessity of RVAD

Early postoperative mortality and morbidity are listed in Table 2. In-hospital mortality, postoperative major morbidities, and length of intensive care unit stay were significantly higher for patients with RVAD compared with those without RVAD. Actuarial survival rate at 1 year was 40% for the RVAD group versus 82% for the non-RVAD group (p < 0.0001, Figure 1). Using multivariate stepwise logistic regression analysis, RVAD use (OR, 18.07; 95% CI, 3.765–86.74; p = 0.0003), preoperative pulmonary vascular resistance (OR, 1.365; 95% CI, 1.125–1.655; p = 0.0016), and preoperative BUN levels (OR, 1.043; 95% CI, 1.004–1.083; p = 0.031) were significant predictors for 1-year mortality.

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Effect of Timing of RVAD Insertion on Outcomes

Twenty-six patients underwent concomitant RVAD insertion while 14 underwent delayed RVAD insertion (median delay of 3 days after LVAD implantation, range 1–66 days). Baseline characteristics were similar between groups, except for the body mass index. Median duration of RVAD support was 13 days (range, 1–103 days) in the concomitant RVAD group versus 25 days (range, 5–104 days) in the delayed RVAD group (p = 0.41). Of patients who underwent concomitant RVAD insertion, 3 (12%) underwent successful transplant during a temporary RVAD support, and 14 (53%) successfully weaned off RVAD support. Of the 14 patients who underwent delayed RVAD insertion, 4 (29%) had successful transplant during a temporary RVAD support, and 6 (43%) were successfully weaned off RVAD support. In-hospital mortality was similar between groups (50% for the delayed group vs. 46% for the concomitant group, p = 0.82). The 1-year actuarial survival was 42% in the concomitant RVAD group and 36% in the delayed group (p = 0.42, Figure 2).

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Outcomes According to the Era

To investigate the impact of the era on outcomes, the cohort was divided into 2 groups: 2000–2004 (Era 1, n = 101) and 2005–2010 (Era 2, n = 181). Preoperative patient’s status significantly varied across the era. Patients in Era 1 were significantly sicker than those in Era 2 with lower ejection fraction (16 ± 5.9% vs. 18 ± 6.2%, p = 0.0013), lower sodium (131 ± 6.7 mmol/L vs. 133 ± 4.4 mmol/L, p = 0.032), higher BUN (42 ± 23 mg/dl vs. 36 ± 18 mg/dl, p = 0.0022) and creatinine (1.8 ± 0.73 mg/dl vs. 1.5 ± 0.58 mg/dl, p = 0.0004), higher AST (131 ± 288 IU/L vs. 51 ± 109 IU/L, p = 0.0013), and lower total protein (5.9 ± 1.6 g/dl vs. 6.6 ± 1.0 g/dl, p < 0.0001). The 1-year survival rate increased significantly from Era 1 (67.2%) to Era 2 (79.7%) (p = 0.0059). Era 1 included 15 patients who required RVAD support and Era 2 included 25. Survival rate at 1 year for RVAD group was 27% in Era 1 and 48% in Era 2, respectively (p = 0.029, Figure 3).

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Impact of Device Type on Outcomes

Incidence of severe RV failure requiring RVAD support was significantly lower in patients with HeartMate II (5.3%) compared with those with HeartMate I (20%) (p = 0.0004). Outcomes were compared according to the type of RV support device either with pulsatile flow device (Thoratec PVAD or Abiomed 5000, n = 27) or continuous flow device (Centrimag, n = 13). The 1-year survival rate was not statistically different between pulsatile (41%) and Centrimag (54%) group (p = 0.28).

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Effect of RVAD Insertion on End-Organ Function

Table 3 demonstrated the time course of hepatic and renal function after RVAD insertion according to in-hospital mortality. In nonsurvivors, hepatic and renal functional marker levels, including AST, ALT, and creatinine, deteriorated with time. However, in survivors, hepatic and renal functions were likely to recover on postoperative day 3. Creatinine levels on postoperative day 3 showed a statistically prominent difference between survivors and nonsurvivors.

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The major findings of this study are that the development of RV failure that requires RVAD support in LVAD recipients is associated with high mortality irrespective of the timing of device insertion.

The use of LVAD has become standard care for heart failure patients with mild inotrops as a bridge to transplantation or as destination therapy.16,17 However, there are still two major limiting factors for further success with LVAD. One is device-related complications such as thromboembolism, infection, and bleeding. Another is the RV failure after LVAD implantation. The recent innovation of technology could dramatically improve device-related complications.17 Furthermore, some studies implied that the continuous flow LVAD might decrease the incidence of RV failure compared with pulsatile flow devices.2,18 Indeed, our study showed that the use of HeartMate II had significantly reduced the postoperative need for RVAD. However, simultaneously, all these studies, including ours, confirmed that the RV failure after LVAD remains problematic in terms of outcomes.

In the current study, 1-year survival rate was 82% for the non-RVAD group and 40% for the RVAD group. The recent data from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) showed 6-month survival rate was 86% for the LVAD group and 56% for the BiVAD group.7 Compared with this registry data, present data showed worse survival for the RVAD group. This is explained by the fact that our cohort included old series since 2000. Patient’s selection for device insertion has significantly changed during the study period, resulting in improving outcomes in the latter half of period. Furthermore, our RVAD cohort only included patients who required “unplanned” RVAD support after LVAD insertion. A previous study showed that “planned” BiVAD implantation improved outcomes compared with delayed conversion.6 This might also influence the outcomes.

Multiple studies have attempted to identify the risk factors for the development of RV failure after LVAD placement.2–6 Like these studies, our study identified preoperative CVP as a risk factor for RVAD implantation. However, in the clinical setting, we cannot precisely predict which patients would newly develop RV failure after LVAD implantation because the etiology of RV failure is multifactorial. Proposed underlying mechanisms include intrinsic myocardial dysfunction, leftward ventricular septum shifting, and insufficient RV afterload reduction.2,19,20 It is important to keep in mind numerous other potential complications after LVAD surgery such as renal failure, infection, and bleeding, which might predispose patients to RV failure. Intra- and perioperative strategies to avoid these complications as well as preoperative optimization to reduce CVP should be made as much as possible to reduce the incidence of RV failure.

Timing of mechanical support for RV failure remains controversial issue. The insertion of RVAD is mandatory before the end-organ malperfusion progresses, as hospital survivors adequately restored end-organ function after RVAD support in contrast to nonsurvivors. However, our results suggest that no benefits are gained by placing RVAD prophylactically in high-risk patients of RV failure after LVAD insertion. Most recently, Aissaoui et al.8 showed results similar to ours. They reported similar 6-month survival between the early RVAD group (50%) and the delayed RVAD group (44%). On the contrary, some reports recommend simultaneous establishment of RVAD with LVAD insertion. Fitzpatrick et al.6 showed superior 1-year survival in the planned BiVAD group (51%) versus in the unplanned RVAD group (29%). However, their series consisted of patients in the old era from 1995. Their long duration of study period undoubtedly have an effect on outcomes similar to ours. Our unplanned RVAD group in Era 2 showed comparable survival (48%) to their planned BiVAD group. Kormos et al.2 reported most comprehensive data regarding RV failure after contemporary continuous flow device insertion. They included 30 patients who required RVAD support. Within this group, patients who received an RVAD within the first 24 hours had better 6-month survival compared with those who received an RVAD later (77% vs. 39%). However, there were only eight patients in the later group. Further studies including larger population would be necessary to draw a conclusion. Loforte et al.14 also described better outcome for simultaneous temporary RVAD insertion. They reported higher in-hospital mortality associated with multiple end-organ failure in the delayed RVAD group. Importantly, patients requiring mechanical RV support already had a great degree of hemodynamic compromise and end-organ malperfusion; therefore, these patients had increased major adverse events and in-hospital mortality rates. One reason explaining our result as opposed to them is that degree of end-organ dysfunction and hemodynamic indices was similar between two groups, suggesting that RVAD was inserted without significant delay once it was clinically necessary. Therefore, from these results, patient status at the timing of RVAD insertion is more likely to be the key determinants affecting survival.

The data from the INTERMACS demonstrated no difference in survival between durable LVAD/durable RVAD and the durable LVAD/temporary RVAD configurations.7 However, our study showed that approximately half of the patients could be weaned from RVAD support with a median duration of 13 days. Recent studies also support our findings with a 20–70% chance of RV recovery, after which RVAD can be removed.8–11,13,14 Furthermore, temporary RVAD with devices such as CentriMag (Levitronix, LLC., Waltham, MA) is easy to implant and explant.11–14 These findings again make surgeons consider prophylactic RVAD insertion in patients at high risk for RV failure.2,14 However, further studies are required to justify this strategy because it could generate unnecessary device insertion and device-related complications. Currently, we only use temporary RVAD for refractory RV failure after LVAD insertion. The use of isolated continuous flow LVAD after optimization of RV status is our first-line strategy.

There are several limitations in this study. This is a retrospective analysis from a single-center experience. HeartMate II was only used in 40% of patients. Furthermore, various type of device was used for RVAD support. Further studies including larger population will be useful to determine the impact of contemporary continuous flow devices on the outcomes. The number of patients receiving RVAD support was relatively low, therefore limiting statistical power. The timing of RVAD insertion was based on the clinical picture of each patient. No definite criteria were used to decide RVAD insertion.

In conclusion, severe RV failure requiring temporary RVAD support after LVAD implantation is associated with poor outcomes. The timing of RVAD insertion does not affect overall outcomes. Preoperative patient status including hemodynamic indices and end-organ function is the key determinants affecting survival. Appropriate pre-, intra-, and postoperative management for RV failure is mandatory to improve outcomes.

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right ventricle; heart failure; ventricular assist device

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