Post-cardiotomy right ventricular failure requiring intraoperative right ventricular assist device placement: real-world experiences

Introduction

Post-cardiotomy right ventricular failure (RVF) is a feared complication of cardiac surgery (1). Reports demonstrate high rates of both in-hospital and 6-month mortality in patients with severe post-cardiotomy RVF (1,2). Traditionally, post-cardiotomy RVF is managed medically via pulmonary vasodilators, fluid balance optimization, and inotropes; however, many cases can be refractory to medical management (3). In such cases, temporary mechanical circulatory support in the form of extracorporeal membrane oxygenation (ECMO), and increasingly, right ventricular assist device (RVAD) support may be beneficial (4). Multiple RVAD devices are available for use. The ProtekDuo (LivaNova, London, UK) is a dual-lumen cannula, which is commonly placed via the right internal jugular vein or the left subclavian vein. The inflow port is placed in the right atrium while the outflow tract is placed in the pulmonary artery, bypassing the right ventricle. Whereas the Impella RP (Abiomed, Danvers, Massachusetts, USA), is a catheter-based, microaxial flow pump placed via the femoral vein. The inflow port is placed within the inferior vena cava and, similarly to the ProtekDuo (LivaNova), the outflow port is placed within the pulmonary artery bypassing the right ventricle (4). While RVAD therapy for isolated ventricular support is becoming more common, historical results are mixed, and little information exists about intraoperative RVF requiring concomitant RVAD placement (5). Although societal guidelines provide definitions of RVF, they lack a standardized treatment algorithm, complicating treatment decisions and leaving much to physician discretion (2,6). Despite no specific criterion for intraoperative RVAD placement, guidelines recommend judicious decision making to avoid serious complications (7,8). Thus, a better understanding of the outcomes of patients with post-cardiotomy RVF requiring intraoperative RVAD placement is needed. Due to a paucity of data regarding these outcomes, we found it important to report our outcomes. We present this article in accordance with the STROBE reporting checklist (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-281/rc).

Methods

Study design and patient selection

This is a single-center retrospective cohort study of all patients who underwent RVAD placement from 2018 to 2023. All patients who underwent concomitant RVAD placement for post-cardiotomy RVF during the index operation were included. The institutional electronic medical record was used to corroborate operative data and obtain patient characteristics. The primary outcome was survival to discharge. Secondary outcomes included: 30-day survival, duration of support, hospital length of stay, and successful weaning of RVAD support. In an effort to reduce potential biases, all consecutive patients requiring intraoperative RVAD placement were included. No patients were excluded from analysis. All devices were initially placed intraoperatively during the index operation. Longitudinal follow-up data were obtained from the electronic medical record. This study was reviewed and approved by the Baylor Scott & White Research Institute Institutional Review Board (IRB# 014-209). Informed consent was waived due to the retrospective nature of the study. This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments.

Device and implant strategy

Over the course of this study, two different venous-pulmonary artery (V-PA) RVADs were utilized: in the earlier part of this study, a surgical RVAD was constructed, while in the later part of the study, the Protek Duo (LivaNova) device was utilized. The surgical RVAD consisted of the direct cannulae of an 8 or 10 mm Gelweave graft anastomosed directly to the main pulmonary artery with a 21-Fr single-stage arterial cannula and a multistage femoral venous drainage cannula. During the later part of our study, percutaneous V-PA cannulation was achieved using the Protek Duo (LivaNova) cannula. Percutaneous V-PA ECMO cannulation was achieved using ultrasound-guided, percutaneous access of the right internal jugular vein or the left subclavian vein. After cannulation, a 7-Fr wedge catheter (Medtronic, Galway, Ireland) is floated into the pulmonary artery and then replaced with a double J Lunderquist wire. A 29-or 31-Fr Protek Duo (LivaNova) cannula is then inserted over this wire and connected to an ECMO circuit.

Device indications and weaning

Placement of RVAD is considered in any postoperative patient with difficulty separating from cardiopulmonary bypass and both echocardiographic and hemodynamic evidence of right ventricular dysfunction. Attention intraoperatively is placed on right ventricular size and motion, new tricuspid valve regurgitation, left ventricular filling, septal bulging, along with hemodynamic parameters. While placement remains, a multidisciplinary decision based on a compilation of these factors, RVAD is not considered unless patients are requiring at least two high-dose ionotropic medications. In our practice, pulmonary vasodilators are rarely used in this setting. Prior to proceeding with RVAD placement, the technical success of the operation is evaluated intraoperatively: all valves are checked for normal function, and any bypass grafts are assessed at surgeon discretion via transit time flow assessment or manual palpation.

In the immediate postoperative phase, the focus of RVAD management is to provide full support to allow for the patient to resolve any acidosis, allow any vasoplegia to dissipate, and prevent end-organ dysfunction. Once patient stability is achieved, the second phase of device management is to achieve euvolemia. This is achieved through diuresis or dialysis if needed. After achieving euvolemia, attention is turned to weaning device support. RVAD flows are gradually weaned and cardiac function assessed with echocardiography and hemodynamic assessment. Once patients are able to tolerate weaning to 2 L of flow with adequate cardiac function demonstrated by echocardiography, we consider decannulation.

Statistical analysis

Descriptive statistics were used to analyze this data. Normality of continuous variables was assessed. Normal continuous variables are reported as mean ± standard deviation, whereas non-normal continuous variables are reported as median [interquartile range (IQR)]. Categorical variables are presented as counts with percentages. The Kaplan-Meier method was used to estimate survival probability. The Kruskal-Wallis test for non-paired non-parametric data was used for data comparison. Categorical data was compared using the Chi-squared test. Significance of all comparative tests was set as a P value <0.05. Any missing data was excluded from the analysis.

Results

From 2018 to 2023, 23 patients experienced intraoperative post-cardiotomy RVF and underwent concomitant RVAD placement. During this time frame, a total of 9,268 cardiac surgeries were performed at Baylor Scott & White Research Institute. Patients with intraoperative post-cardiotomy RVF requiring RVAD placement represented 0.24% (23/9,268) of all cases. Of these 23 patients, 22 underwent Protek Duo (LivaNova) RVAD placement, while 1 patient underwent surgical RVAD placement. Median patient age was 67 (IQR, 60–72) years, median body mass index (BMI) was 26.7 (IQR, 23.5–31.8) kg/m², and 13 (56.5%) patients were male. Common co-morbidities are listed in Table 1. Median left ventricular ejection fraction was 25% (IQR, 11.3–50%) and median preoperative New York Heart Association heart failure classification was 3.5 (IQR, 1.5–4). In those with an available Society of Thoracic Surgeons predicted risk of mortality (STS-PROM) operative risk was 1.3% (IQR, 1.1–3.7%). Operative complexity was high with 13 (56.5%) patients requiring repeat sternotomy (Table 2). Primary operative indications included: left ventricular assist device (LVAD) (n=14), mitral valve replacement/repair (n=3), Aortic valve replacement/repair (n=4), transposition of right coronary artery (n=1), and patent foramen ovale closure (n=1). Of these, 10/23 (43.5%) patients underwent an additional procedure concomitantly with the primary indication for operation. These included: tricuspid valve replacement/repair (n=6), mitral valve replacement/repair (n=4), and coronary artery bypass grafting (n=4). As Baylor Scott & White Research Institute is a destination therapy LVAD center, all patients who received an LVAD did so for destination therapy.

The median duration of RVAD support was 8 (IQR, 7–17) days, and 2 patients required multiple rounds of RVAD support. Complications included: stroke (n=4), renal failure requiring renal replacement therapy (n=6), and clinically significant bleeding requiring transfusion or reoperation (n=16). There were no thrombotic events related to the device. Mechanical circulatory support was successfully withdrawn in 20 (87.0%) patients, while 3 patients expired while receiving RVAD support. There were 5 in-hospital mortalities, equating to a survival to discharge rate of 78.3% (18/23). Similarly, 30-day survival was 78.3% (18/23). At a follow-up duration of 219 (IQR, 61–469) days, overall survival was 52.2% (12/23). Kaplan-Meier estimated 1-year patient survival was 69.6% (Figure 1). Overall, median hospital length of stay was 30 (IQR, 20–41) days (Table 3). In total, 13 (56.5%) patients’ primary operation was LVAD placement. In patients who underwent primary LVAD placement median RVAD duration was 11 (IQR, 7.5–16) days, 30-day mortality was 7.7% (1/13), and 92.3% (12/13) of patients were successfully weaned from RVAD support. A total of 10 (43.5%) patients had a primary operation which was not LVAD placement. In these patients median RVAD duration was 9 (IQR, 2–17) days, 30-day mortality was 30% (3/10), and 80% (8/10). When compared these two groups were not significantly different in RVAD duration or successful RVAD weaning: P=0.23 and P=0.38. Thirty-day mortality was higher in the non-LVAD cohort: P=0.002.

Figure 1 Kaplan-Meier analysis of patient survival. RVAD, right ventricular assist device.

Discussion

Post-cardiotomy RVF is a complex problem with a high morbidity and mortality (1,2). Although medical management with inotropes, pulmonary vasodilators, and fluid balance optimization is the mainstay of treatment, refractory cases may require temporary mechanical circulatory support (3,4). While univentricular support via RVAD is becoming more common, there remains little data regarding this strategy, particularly in patients requiring concomitant RVAD for intraoperative RVF (4,5). This retrospective review of consecutive patients with intraoperative RVF requiring concomitant RVAD placement noted the following: acceptable overall patient outcomes, low rate of repeat RVAD cannulation, a short duration of support, and acceptable short-term outcomes in patients able to wean successfully from RVAD support.

Although guidelines recommend early initiation of ventricular support, there remains little data assessing concomitant RVAD placement for intraoperative RVF. Previous reports estimate in-hospital mortality up to 75% in all patients with severe post-cardiotomy RVF, and early experiences with RVAD support demonstrated in-hospital mortality of 33% (1,9). In contrast, we demonstrate an in-hospital mortality of 21.7% in patients requiring RVAD support. This difference is notable as the need for RVAD support for post-cardiotomy RVF has been associated with worse patient outcomes (10). Furthermore, compared to a previous single-center analysis of all patients requiring RVAD support, including post-cardiotomy RVF, our cohort demonstrates a survival-to-discharge of 78.3% compared to 47.4% (4). As the post-cardiotomy RVF cohort has traditionally been associated with particularly poor outcomes, these findings suggest early initiation of RVAD support may be a beneficial adjunctive therapy in this population. Prior data have reported 1-year survival rates of 50% in patients who underwent RVAD placement for acute RVF, whereas our Kaplan-Meier survival analysis demonstrated a 1-year survival of 69.6% (11). Compared to prior data, our 1-year survival is promising; however, when assessing overall survival, 52.2%, our mortality rates are similar to prior data. These findings suggest early initiation of RVAD may improve early outcomes, and there are likely significant sequelae of post-cardiotomy RVF which impact long-term outcomes.

Although we noted improved early survival compared to prior data, we did observe a high rate of complications in these patients. Overall, 26.1% (6/23) of patients required renal replacement therapy, 17.4% (4/23) of patients suffered a clinically documented stroke, and 69.6% (17/23) of patients suffered a clinically significant bleeding event requiring re-operation or multiple transfusions. These observations underscore the severity of post-cardiotomy RVF and undoubtedly affect patient outcomes. Strategies to mitigating further complications in this cohort will be important to identify.

We must note that while our outcomes are improved compared to historical data, technological advancements in RVAD devices may have a significant impact on our outcomes. Moazami et al.’s analysis of patients with isolated post-cardiotomy RVF demonstrated high in-hospital mortality and failure to wean compared to our analysis (9). However, this data included a significant percentage (90%) of patients who received surgical RVAD. In our experiences use of the Protek Duo (LivaNova) allows for increased left ventricular filling, decreases in CVP, and for decreased pressor support, which may in turn help clear lactate and preserve renal function compared to traditional methods. Further, these patients are often able to be extubated and mobilized, unlike patients requiring traditional ECMO support. In the Baylor Scott & White Research Institute, we do not consider the presence of an RVAD to be a contraindication to extubation. On the contrary, as we typically use an oxygenator with the RVAD, we are able to be more aggressive with extubation, as the RVAD is used to support pulmonary function as needed. Thus, airway protection is our primary concern in most of these patients, and most patients are able to be extubated on the same day of surgery. Further, we are able to utilize the same enhanced recovery after surgery mobilization protocols. These include bedside exercises on the day of surgery, and sitting patients in a chair and walking on postoperative day 1. Although we believe early initiation of therapy is important, we hypothesize that technological improvements have played a significant role in the improved outcomes observed.

We observed a high rate of successful RVAD weaning overall and 30-day survival of 90% patients who were able to be successfully weaned from RVAD support. While this finding was not unexpected, we still found it noteworthy. Not only will a better understanding of the indications for RVAD support be important, but future analysis assessing predictors of successful right ventricular recovery will be necessary to better triaging the implementation of RVAD support.

Compared to national data, the overall STS-PROM in patients with an applicable score was similar. Our cohort had a median STS-PROM of 1.95% (IQR, 1.18–3.94%) compared to national data demonstrating predicted risk of operative mortality of 1.7% for CABG, 2.04% for aortic valve replacement, 1.16% for mitral valve repair, and 5.6% for tricuspid valve surgery (12,13). Those undergoing LVAD placement had a median Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile of 1 (IQR, 1–1.5), with 12/13 (92.3%) being INTERMACS profile 1 or 2. Only one patient was INTERMACS profile 3. Compared to national data, our patients who underwent LVAD placement appeared to be a higher-risk cohort, as national data suggests roughly 50% of patients undergoing LVAD placement are INTERMACS profile 1–2 (14). These findings suggest a high variability of preoperative risk profiles in our cohort and underscore the difficulties of predicting post-cardiotomy RVF preoperatively. However, the heterogeneity of our cohort must be acknowledged. While post-cardiotomy RVF appears to be difficult to predict preoperatively, the patients undergoing LVAD placement are certainly a higher-risk group. Data suggests patients undergoing LVAD placement are at a risk of RVF ranging from 9% to 42% (15). Compared to the general cardiac surgical population, this risk is substantially higher, where the reported rate of post-cardiotomy RVF is 0.04–0.1% (16). The increased rates of post-cardiotomy RVF in patients undergoing LVAD placement are proposed to be multifactorial, given these patients heart failure and common concomitant disease; however, the development of RVF in this population remains difficult to predict (17). While the general cardiac surgical population remains a lower risk for post-cardiotomy RVF, multiple factors have been proposed to contribute to the development of post-cardiotomy RVF: suboptimal myocardial protection, long cardiopulmonary bypass time, ischemia-reperfusion injury, atrial arrhythmias, preexisting pulmonary hypertension, and protamine-induced pulmonary hypertension (18). Data suggests patients right ventricular dysfunction is not uncommon following mitral valve surgery (19). While, to our knowledge, there has been no data correlating mitral valve surgery with intraoperative RVF, it is possible that this increased risk of right ventricular dysfunction may contribute to an increased risk of RVF in mitral valve surgery. Further, significant tricuspid valve disease has been associated with right ventricular remodeling and dysfunction (20,21). The pathophysiologic changes secondary to tricuspid valve disease may place these patients at a higher risk of post-cardiotomy RVF. Future studies will be important to assessing the true risks of post-cardiotomy RVF following mitral or tricuspid valve surgery.

Interestingly, while we noted no differences in median duration of support or successful weaning between the two cohorts, we observed a higher 30-day mortality rate in the non-LVAD cohort. This suggests patients undergoing cardiac procedures other than LVAD implantation who experience post-cardiotomy RVF may be a higher-risk cohort. This finding mirrors the results of the RECOVER RIGHT study, which observed a higher mortality in patients who underwent RVAD support for postcardiotomy/post-myocardial infarction shock opposed to those who experienced RVF following LVAD placement (22). The follow-up study, which included 60 patients, showed similarly impressive overall survival rates, with a higher mortality in the postcardiotomy/post-myocardial infarction shock (23). This is possibly due to a lack of chronic compensation in these patients; however, future studies will be important to better assess the risk of post-cardiotomy RVF in these patients compared to LVAD implantation patients.

While the majority of patients within our cohort underwent RVAD support with a ProtekDuo (LivaNova), it is important to acknowledge other forms of right ventricular support. The Impella RP (Abiomed) is a percutaneous microaxial flow pump approved for right ventricular support in the setting of medically refractory RVF. Previous data have reported overall 30-day survival rates of 73.3%, 53.3%, and 51% following Impella RP (Abiomed) RVAD support for RVF (22-25). Similarly, the THRIVE registry, which included both ProtekDuo (LivaNova) and Impella RP (Abiomed) devices, reported a survival to discharge rate of 43% (26). Compared to previous data, our 30-day survival of 78.3% compares favorably and suggests concomitant RVAD placement using the ProtekDuo (LivaNova) for intraoperative RVF is a viable treatment strategy. Future data will be important to further understanding this treatment strategy compared to other methods of right ventricular support.

While the heterogeneity of our patient population limits the strength of this analysis, we found it important to report our results given the paucity of data surrounding intraoperative initiation of RVAD support in the setting of early post-cardiotomy RVF. Importantly, future analyses will be integral to understanding the nuances of this treatment therapy, particularly in these heterogenous patient populations.

Limitations

This study is susceptible to the same limitations as all retrospective analyses: namely patient selection bias. Importantly, the assessment and decision to implement RVAD support have a significant subjective component and likely has significant provider variation, which may have influenced our findings. Our analysis lacks a comparator group; either patients with severe RVF supported with vasoactive medications alone or a group supported with more traditional venoarterial (VA)-ECMO would be suitable for a comparative group in future studies. Unfortunately, given the significant clinical variability in treatment strategies for RVF, such a comparator group was not possible in our study. We must also acknowledge the heterogeneity of our patient population and the possibility for significant differences between patients undergoing LVAD placement compared to other cardiac surgeries. Further, given our limited cohort size, we are unable to draw any conclusions based on the type of surgery performed or the etiology of RVF. However, given the paucity of data addressing this topic and our small sample size, larger studies will be necessary to understand these differences.

Conclusions

Post-cardiotomy RVF remains a morbid condition with poor patient outcomes. This analysis of patients with intraoperative RVF requiring intraoperative RVAD support suggests this may be a helpful adjunctive therapy in this patient population. Further, we believe these findings support recommendations calling for early initiation of therapy to support the failing right ventricle. Further data will be important to understand how intraoperative RVAD placement compares to medical management and delayed RVAD placement strategies.

Acknowledgments

This study has been presented orally at the Technology and Heart Failure Therapeutics Annual Meeting on March 4, 2024.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-281/rc

Data Sharing Statement: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-281/dss

Peer Review File: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-281/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-281/coif). A.A. and T.J.G. are part of the Abiomed speaker’s bureau. The other authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. This study was reviewed and approved by the Baylor Scott & White Research Institute Institutional Review Board (IRB# 014-209). Informed consent was waived due to the retrospective nature of the study. This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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