Clinical Predictors and Outcomes After Left Ventricular Assist Device Implantation and Tracheostomy.

BACKGROUND: Postoperative respiratory failure is a major complication that affects up to 10% of patients who undergo cardiac surgery and has a high in-hospital mortality rate. Few studies have investigated whether patients who require tracheostomy for postoperative respiratory failure after continuous-flow left ventricular assist device (CF-LVAD) implantation have worse survival outcomes than patients who do not. OBJECTIVE: To identify risk factors for respiratory failure necessitating tracheostomy in CF-LVAD recipients and to compare survival outcomes between those who did and did not require tracheostomy. METHODS: Consecutive patients who underwent primary CF-LVAD placement at a single institution between August 1, 2002, and December 31, 2019, were retrospectively reviewed. Propensity score matching accounted for baseline differences between the tracheostomy and nontracheostomy groups. Multivariate logistic regression was used to identify tracheostomy risk factors and 90-day survival; Kaplan-Meier analysis was used to assess midterm survival. RESULTS: During the study period, 664 patients received a CF-LVAD; 106 (16.0%) underwent tracheostomy for respiratory failure. Propensity score matching produced 103 matched tracheostomy-nontracheostomy pairs. Patients who underwent tracheostomy were older (mean [SD] age, 57.9 [12.3] vs 54.6 [13.9] years; P = .02) and more likely to need preoperative mechanical circulatory support (61.3% vs 47.8%; P = .01) and preoperative intubation (27.4% vs 8.8%; P < .001); serum creatinine was higher in the tracheostomy group (mean [SD], 1.7 [1.0] vs 1.4 [0.6] mg/dL; P < .001), correlating with tracheostomy need (odds ratio, 1.76; 95% CI, 1.21-2.56; P = .003). Both before and after propensity matching, 30-day, 60-day, 90-day, and 1-year survival were worse in patients who underwent tracheostomy. Median follow-up was 0.8 years (range, 0.0-11.2 years). Three-year Kaplan-Meier survival was significantly worse for the tracheostomy group before (22.0% vs 61.0%; P < .001) and after (22.4% vs 48.3%; P < .001) matching. CONCLUSION: Given the substantially increased probability of death in patients who develop respiratory failure and need tracheostomy, those at high risk for respiratory failure should be carefully considered for CF-LVAD implantation. Comprehensive management to decrease respiratory failure before and after surgery is critical.

Preoperative hyponatremia and survival after left ventricular assist device implantation.

BACKGROUND: Hyponatremia is associated with adverse outcomes in heart failure and after cardiac surgery. We hypothesized that hyponatremia is associated with poorer short-term and longer term survival in patients after continuous-flow left ventricular assist device (CF-LVAD) placement. METHODS: We reviewed a single-center database of patients who received a CF-LVAD during 2012-2017. Sodium (Na) values obtained within 14 days before CF-LVAD insertion were averaged; patients (n = 332) were divided into hyponatremia (mean Na <135 mEq/L; n = 160; 48.2%) and normonatremia groups (mean Na 135-145 mEq/L; n = 172; 51.8%). Patients requiring preoperative dialysis or pump exchange were excluded. We compared outcomes between preoperative hyponatremia and normonatremia groups. RESULTS: The two groups' baseline characteristics were similar, although hyponatremia patients more often had preoperative mechanical circulatory support (44.4% vs. 31.4%, p = 0.002). Although hyponatremic and normonatremic patients did not differ in 30-day mortality (7.5% vs. 6.5%, p = 0.7), preoperative hyponatremia was associated with greater 5-year mortality (61% vs. 44%, p = 0.03). On binary logistic regression analysis, the strongest independent predictors of late mortality were hyponatremia (odds ratio [OR] 1.88, 95% CI [1.07-3.31], p = 0.02), older age (OR 1.03, 95% CI [1.01-1.05], p = 0.01), and elevated mean right atrial pressure/pulmonary capillary wedge pressure ratio (OR 4.69, 95% CI [1.76-12.47], p = 0.002). CONCLUSIONS: Hyponatremia was not associated with greater early mortality but was associated with poorer late survival. The optimal timing of LVAD implantation in relation to hyponatremia, and whether correcting hyponatremia perioperatively improves long-term survival, should be investigated.

The influence of preoperative dialysis on survival after continuous-flow left ventricular assist device implantation.

OBJECTIVES: Dialysis is considered a contraindication to continuous-flow left ventricular assist device (CF-LVAD) implantation. We evaluated clinical outcomes and survival in carefully selected, low-risk patients with renal failure who required dialysis before CF-LVAD implantation. METHODS: We extracted medical record data of patients who underwent CF-LVAD placement at our centre between 1 January 2006 and 31 August 2017, with 2 clinical scenarios: those who required long-term (>14 days) dialysis and those who required short-term (≤14 days) dialysis immediately before implantation. Demographic, clinical and intraoperative characteristics and survival outcomes were assessed. RESULTS: Of 621 patients who underwent CF-LVAD implantation during the study period, 31 underwent dialysis beforehand. Of these, 17 required long-term dialysis (13 haemodialysis, 4 peritoneal dialysis), and 14 underwent short-term haemodialysis. Compared with the long-term dialysis patients, the short-term dialysis patients were more likely to be Interagency Registry for Mechanically Assisted Circulatory Support profile 1-2 (92.9% vs 70.6%; P < 0.001), to have needed preoperative mechanical circulatory support (78.6% vs 70.6%; P < 0.01) and to have higher in-hospital mortality (85.7% vs 29.4%; P = 0.01). Patients stable on long-term dialysis had acceptable overall survival and markedly better 6-month and 1-year survival than those with short-term dialysis before implantation (64.7% vs 14.3% and 58.8% vs 7.1%, respectively; P < 0.001). CONCLUSIONS: Carefully selected patients who are stable on long-term dialysis have acceptable survival rates after CF-LVAD implantation. Patients with acute renal failure had much poorer outcomes than those with chronic end-stage renal disease.

Predictors of renal replacement therapy in patients with continuous flow left ventricular assist devices.

Renal replacement therapy (RRT) after continuous flow left ventricular assist device (CF-LVAD) implantation significantly affects patients' quality of life and survival. To identify preoperative prognostic markers in patients requiring RRT after CF-LVAD implantation, we retrospectively reviewed data from patients who underwent implantation of a CF-LVAD at our institution during 2012-2017. Patients who required preoperative RRT were excluded. Preoperative and operative characteristics, as well as survival and adverse events, were compared between 74 (22.2%) patients requiring any duration of postoperative RRT and 259 (77.8%) not requiring RRT. Patients requiring RRT experienced more postoperative complications than patients who did not, including respiratory failure necessitating tracheostomy (35.7% vs 2.5%, p < 0.001), reoperation for bleeding (34.3% vs 11.7%, p < 0.001), and right heart failure necessitating perioperative mechanical circulatory support (32.4% vs 6.9%, p < 0.001). Patients requiring postoperative RRT also had poorer survival at 30 days (74.7% vs 98.8%), 6 months (48.2% vs 95.1%), and 12 months (45.3% vs 90.2%) (p < 0.001). Significant predictors of RRT after CF-LVAD implantation included urine proteinuria (odds ratio [OR] 3.6, 95% confidence interval [CI] [1.7-7.6], p = 0.001), estimated glomerular filtration rate < 45 mL/min/1.73 m2 (OR 3.4, 95% CI [1.5-17.8], p = 0.004), and mean right atrial pressure to pulmonary capillary wedge pressure ratio ≥ 0.54 (OR 2.6, 95% CI [1.3-5.], p = 0.01). Of the 74 RRT patients, 11 (14.9%) recovered renal function before discharge, 36 (48.6%) still required RRT after discharge, and 27 (36.5%) died before discharge. We conclude that preoperative renal and right ventricular dysfunction significantly predict postoperative renal failure and mortality after CF-LVAD implantation.

Continuous-Flow Left Ventricular Assist Device Therapy in Adults with Transposition of the Great Vessels.

An increasing number of children with congenital heart disease are surviving into adulthood and subsequently developing end-stage heart failure. Two example populations are adults who have been previously operated on for congenitally corrected transposition of the great arteries (CCTGA) and transposition of the great arteries (TGA). Implantation of a continuous flow left ventricular assist device (CF-LVAD) in these patients can present unusual anatomical and physiologic challenges. In this report, we describe outcomes of CF-LVAD implantation in three such patients. These cases demonstrate the feasibility of implanting a CF-LVAD in patients who have undergone surgery for CCTGA and/or TGA.

Left Ventricular Recovery with Explantation of Continuous-Flow Left Ventricular Assist Device after 5 Years of Support.

Mechanical circulatory support may result in sufficient myocardial recovery to allow for explantation of the left ventricular assist device (LVAD). The duration of support associated with left ventricular recovery has generally been 6-12 months. In this report, we present a patient in whom the left ventricle recovered after 5 years of support with a LVAD. Our report demonstrates that long-term monitoring for left ventricular recovery is prudent and may allow for late device explantation.

Effect of cardiac arrest with aortic cross-clamping during left ventricular assist device implantation.

OBJECTIVES: Some patients who undergo continuous-flow left ventricular assist device (CF-LVAD) implantation require concomitant procedures that can be performed with or without cardiac arrest under aortic cross-clamping (AXC). Procedures normally performed with cardiac arrest are sometimes avoided or performed without cardiac arrest because it may be detrimental to right heart function. However, the effects of cardiac arrest on patients with advanced heart failure necessitating CF-LVAD support have not been thoroughly studied. We examined our single-centre experience to determine whether cardiac arrest during CF-LVAD implantation was associated with worse patient outcomes. METHODS: From November 2003 to March 2016, a total of 526 patients with chronic end-stage heart failure underwent primary CF-LVAD implantation. Preoperative demographics, postoperative complications and mortality rates were compared between patients who required cardiac arrest with AXC (n = 50) and those who did not (n = 476). RESULTS: The most frequently performed procedure requiring AXC was aortic valve closure (n = 23, 26.1%). Although the AXC group had longer cardiopulmonary bypass times (P < 0.01), long-term (5-year) survival was similar in AXC and non-AXC patients (P = 0.13). Also, postoperative right heart failure (P = 0.15) and neurological dysfunction (P = 0.89) rates were not significantly different between the 2 groups. Cox proportional hazards analysis showed that cardiac arrest with AXC was not an independent predictor of mortality (hazard ratio, 0.89; P = 0.73). CONCLUSIONS: Cardiac arrest with AXC during CF-LVAD implantation did not negatively affect long-term survival or the incidence of right ventricular failure or stroke. These findings should be considered in deciding surgical strategies. Additional investigation may be warranted to further understand the effects of cardiac arrest during LVAD implantation.

Accuracy of Postoperative Risk Scores for Survival Prediction in Interagency Registry for Mechanically Assisted Circulatory Support Profile 1 Continuous-Flow Left Ventricular Assist Device Recipients.

In this study, we sought to determine the accuracy of several critical care risk scores for predicting survival of Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Profile 1 patients after continuous-flow left ventricular assist device (CF-LVAD) placement. We retrospectively analyzed the records of 605 patients who underwent CF-LVAD implantation between 2003 and 2016. We calculated the preoperative HeartMate II Risk Score (HMRS) and preoperative Right Ventricular Failure Risk Score (RVFRS) and the following risk scores for postoperative days 1-5: HMRS, RVFRS, Model for End-stage Liver Disease (MELD), MELD-eXcluding International Normalized Ratio, Post Cardiac Surgery (POCAS) risk score, Sequential Organ Failure Assessment (SOFA) risk score, and Acute Physiology and Chronic Health Evaluation III. The preoperative scores and the postoperative day 1, 5-day mean, and 5-day maximum scores were entered into a receiver operating characteristic curve analysis to examine accuracy for predicting 30-day, 90-day, and 1-year survival. The mean POCAS score was the best predictor of 30-day and 90-day survival (area under the curve [AUC] = 0.869 and 0.816). The postoperative mean RVFRS was the best predictor of 1-year survival (AUC = 0.7908). The postoperative maximum and mean RVFRS and HMRS were more accurate than the preoperative scores. Both of these risk score measurements of acuity in the postoperative intensive care unit setting help predict early mortality after LVAD implantation.

Outcomes of Repeat Left Ventricular Assist Device Exchange.

Implantable continuous-flow left ventricular assist devices (CF-LVADs) are used for long-term LV support in bridging patients to heart transplantation or as destination therapy. With prolonged support times, some patients will have repeat complications necessitating multiple device exchanges. To elucidate the safety and efficacy of repeat device exchange, we retrospectively reviewed data from 25 patients who underwent two or more CF-LVAD implantations between July 2005 and August 2017. Indications for exchange were thrombus/hemolysis (n = 8, 32%), electromechanical device malfunction (n = 14, 56%), and infection (n = 3, 12%). The implanted devices were the HeartMate II (n = 13, 52%), the HeartWare HVAD (n = 11, 44%), and the Jarvik 2000 (n = 1, 4%). Average hospital length of stay was 44 days (range 4-221 days), and 17 patients (68%) survived to discharge. Average duration of support after the most recent LVAD implantation was 802 days (range 1-3,229 days). Overall survival was 72% at 1 year and 60% at 2 years. Postoperative complications included respiratory failure in five patients (20%), device infection in five (20%), bleeding requiring reoperation in four (16%), neurologic dysfunction in four (16%), and acute renal failure in two (8%). Overall, our data suggest that repeat LVAD exchange is a feasible option for patients with recurrent device-related complications.

Plasmapheresis in Patients With Heparin-induced Thrombocytopenia Requiring Ventricular Assist Device.

Anticoagulation with unfractionated heparin is vital to reduce the risk of thromboembolic events during cardiopulmonary bypass and left ventricular assist device placement. However patients with heparin-induced thrombocytopenia are at risk of developing immune-mediated thrombotic events. We describe 2 patients with heparin-induced thrombocytopenia confirmed via serotonin release assay who were successfully treated with plasmapheresis exchange before left ventricular assist device placement.

Concomitant valve procedures in patients undergoing continuous-flow left ventricular assist device implantation: A single-center experience.

OBJECTIVE: Long-term support with continuous-flow left ventricular assist devices (CF-LVADs) has improved the outcomes of patients with end-stage heart failure. However, valve disease management in patients who undergo CF-LVAD implantation remains controversial. The aim of this study was to assess our single-center experience with patients who underwent a concomitant valve procedure during implantation of a CF-LVAD. METHODS: From November 2003 through March 2016, 526 patients underwent primary CF-LVAD implantation with a HeartMate II (St Jude Inc, St Paul, Minn; n = 403) or HeartWare (Medtronic, Minneapolis, Minn; n = 123) device at our center. Of those, 91 underwent a concomitant valve procedure during implantation (CF-LVAD+valve procedure group), whereas 435 did not (CF-LVAD-only group). We compared preoperative characteristics and short-term and mid-term survival rates between these groups. RESULTS: The concomitant valve procedures performed included 13 tricuspid valve repairs, 19 aortic valve repairs or replacements, 30 mitral valve repairs or replacements, and 29 double valve repairs or replacements. Survival rates at 1 month, 6 months, 12 months, and 24 months were 90.3%, 81.4%, 74.9%, and 67.4%, respectively, for the CF-LVAD-only group and 89.0%, 75.8%, 70.3%, and 65.9%, respectively, for the CF-LVAD+valve procedure group (P = .55). The results of Cox regression multivariable modeling showed that performing a concomitant valve procedure was not an independent predictor of mortality (hazard ratio, 1.29; 95% confidence interval, 0.96-1.74; P = .08). CONCLUSIONS: In our experience, performing a concomitant valve procedure during CF-LVAD implantation was not associated with an increased mortality rate. The decision to perform a concomitant valve procedure should be made primarily on the basis of clinical indications for the procedure.

Severe LVAD-related infections requiring surgical treatment: Incidence, predictors, effect on survival, and impact of device selection.

BACKGROUND: Left ventricular assist devices (LVADs) are being used more frequently for treating refractory, advanced heart failure. However, infection remains a frequent complication. In this study, we analyzed the incidence of severe infections in LVAD recipients to determine its impact on survival. METHODS: From May 2009 through March 2016, 437 patients with advanced heart failure underwent implantation of a continuous-flow LVAD (n = 314, HeartMate II LVAD [Abbott Laboratories, Abbott Park, IL]; n = 123 HeartWare HVAD [Medtronic, Minneapolis, MN]). We analyzed the rate of severe device infection requiring surgical intervention or involving sepsis and the impact of severe infection on outcomes in patients on long-term LVAD support. RESULTS: Infection occurred in 244 patients (HeartMate II, n = 186; HVAD, n = 58); severe infections developed in 160 patients (HeartMate II, n = 119; HVAD, n = 41). HeartMate II recipients had 344 severe infection events (0.63 events per patient-year [EPPY]), whereas HeartWare recipients had 89 severe infection events (0.42 EPPY; P = 0.047). HeartMate II recipients had a higher incidence of pump infections (P < 0.001). Severe infections did not significantly affect survival (P = 0.42). CONCLUSIONS: Although HeartMate II patients had a significantly higher incidence of pump infections requiring surgical treatment, survival was not adversely affected. The difference in postoperative infection rates may be an important factor in device type selection.

A left ventricular end-diastolic dimension less than 6.0 cm is associated with mortality after implantation of an axial-flow pump.

OBJECTIVE: The effects of having a lower left ventricular end-diastolic dimension before HeartMate II (Thoratec Corp, Pleasanton, Calif) left ventricular assist device implantation remain unclear. We analyzed our single-center data on HeartMate II implantation to determine whether having a lower left ventricular end-diastolic dimension preoperatively was associated with inferior outcomes. METHODS: From November 2003 to March 2016, 393 patients with chronic heart failure underwent primary HeartMate II implantation. We compared the preoperative left ventricular end-diastolic dimension and associated survival outcomes of these patients to determine the left ventricular end-diastolic dimension cutoff for worse overall survival. Then, we compared the preoperative demographics, stroke rate, and mortality of patients with a left ventricular end-diastolic dimension above the cutoff for worse survival with those of patients with a left ventricular end-diastolic dimension below the cutoff. RESULTS: A Cox multivariate regression model showed that low left ventricular end-diastolic dimension was an independent predictor of mortality (hazard ratio, 1.49; P = .02). The Contal and O'Quigley method showed that overall survival postimplantation was decreased in patients with a left ventricular end-diastolic dimension less than 6.0 cm (n = 91). Kaplan-Meier analysis confirmed that the left ventricular end-diastolic dimension less than 6.0 cm group had lower overall survival than the left ventricular end-diastolic dimension 6.0 cm or greater group (P = .04). Furthermore, a competing-risk analysis showed that postoperative stroke was more common in the left ventricular end-diastolic dimension less than 6.0 cm group than in the left ventricular end-diastolic dimension 6.0 cm or greater group (P < .01). CONCLUSIONS: Overall survival was decreased and postoperative stroke was increased in HeartMate II recipients with a preoperative left ventricular end-diastolic dimension less than 6.0 cm. Future research should determine the left ventricular end-diastolic dimension cutoff values for safely implanting other support devices, and device designs should be improved to better accommodate the needs of patients with a limited left ventricle size.

Fatal Neurologic Dysfunction During Continuous-Flow Left Ventricular Assist Device Support.

BACKGROUND: During continuous-flow left ventricular assist device (CF-LVAD) support, neurologic dysfunction (ND) is a common complication and can be fatal. Few reports provide detailed data on neurologic mortality in such patients. Therefore, we examined ND-related mortality during CF-LVAD support. METHODS: Between November 2003 and March 2016, 526 patients underwent implantation of a CF-LVAD (403 HeartMate II [Thoratec, Pleasanton, CA] and 123 HVAD [HeartWare International, Framingham, MA]) at our center. We categorized ND as hemorrhagic or ischemic and recorded resulting deaths. Records were reviewed to determine preoperative demographics, perioperative variables, prevalence and causes of postimplantation ND, duration of support until ND, time from ND to death, laboratory data and medications at the time of ND, post-ND treatment procedures, and causes of hemorrhagic ND. We also performed Cox multivariable logistic regression analysis to identify predictors of ND-related mortality by calculating odds ratios and confidence intervals. RESULTS: Neurologic dysfunction occurred in 141 patients (26.8%), 48 (9.1%) of whom subsequently died. Median duration of left ventricular assist device support before ND was 230 days (range, 3 to 2,422), and median time from ND to death was 3.5 days (range, 0 to 55). Parenchymal hemorrhage was the most frequent cause of early conversion (76.7%). In the Cox multivariable regression analysis, predictors of fatal ND were age, ischemic cause of heart failure, history of stroke, and longer intraoperative aortic cross-clamp time. CONCLUSIONS: Our study elucidates the characteristics and risk factors of patients who died of ND during CF-LVAD support. Further studies are required to find ways to decrease the incidence of fatal ND during CF-LVAD support.

Predictive value of preoperative serum albumin levels on outcomes in patients undergoing LVAD implantation.

BACKGROUND: We performed a single-center retrospective analysis to determine whether preoperative serum albumin levels were associated with postoperative adverse events and short- and long-term survival in patients who underwent continuous-flow left ventricular assist device (CF-LVAD) implantation. METHODS: From November 2003 through March 2016, 526 patients underwent CF-LVAD implantation. Patients whose preoperative serum albumin level was normal (≥3.5 g/dL) were compared to patients with preoperative hypoalbuminemia (<3.5 g/dL), which was further categorized as moderate (2.5-3.5 g/dL) or severe (<2.5 g/dL). These groups were compared regarding preoperative demographics, incidence of postoperative complications, and long-term survival. RESULTS: Patients with hypoalbuminemia had higher serum levels of liver enzymes (P < 0.05) and total bilirubin (P < 0.001) and significantly lower platelet counts (P = 0.02) and prealbumin levels (P < 0.001) than patients with normal preoperative albumin levels. Survival in patients with moderate and severe preoperative hypoalbuminemia was significantly decreased compared with patients with normal preoperative serum albumin levels (P < 0.001). Preoperative hypoalbuminemia was also associated with higher incidences of postoperative infection, gastrointestinal bleeding, neurological dysfunction, and acute kidney injury (P ≤ 0.01 for all) but did not affect the success of bridge to transplantation or survival after transplantation. CONCLUSIONS: Our data demonstrated that there is a significant association of preoperative low serum albumin levels with postoperative adverse outcomes and lower survival rates. This highlights the importance of a patient's preoperative nutritional status on postoperative outcomes after CF-LVAD implantation.

HeartMate II implantation technique that spares the sternum and ascending aorta.

Left ventricular assist devices (LVADs) have become the standard therapy for patients with end-stage heart failure, and the use of LVADs for long-term support has grown exponentially over the past decade. As the number of LVAD implantations has increased, surgeons have faced more challenging cases, such as those in which the patient has previously undergone a sternotomy. The HeartMate II is one of the most widely implanted LVADs. The standard procedure for HeartMate II implantation is median sternotomy and sewing the outflow graft to the ascending aorta. However, in patients with sternal comorbidities, it can be advantageous to use a less invasive approach that avoids this procedure. We describe the case of a 64-year-old man with a history of end-stage ischemic cardiomyopathy who had previously undergone a median sternotomy and a coronary artery bypass grafting operation and had patent grafts. He required a HeartMate II LVAD (destination therapy), which was implanted via a left subcostal incision; the pump was placed subdiaphragmatically, and the outflow graft was sewed to the descending aorta to avoid a complicated redo cardiac operation via median sternotomy and to minimize the risk of injuring the patent bypass grafts. The patient survived for more than 500 days postoperatively. This approach is feasible and could be a safer method for implanting a HeartMate II device in patients with serious comorbidities that preclude the use of the traditional implantation techniques.

Incidence, Predictors, and Significance of Ventricular Arrhythmias in Patients With Continuous-Flow Left Ventricular Assist Devices: A 15-Year Institutional Experience.

OBJECTIVES: The aim of this study was to evaluate the incidence, predictors, and associated mortality of pre-implantation, early, and late ventricular arrhythmias (VAs) in patients receiving continuous-flow left ventricular assist devices (CFLVADs). BACKGROUND: VAs are common both pre- and post-implantation of left ventricular assist devices. Limited data exist on their prognostic impact in contemporary CFLVADs. METHODS: A retrospective review was performed to identify patients who underwent CFLVAD implantation between 2000 and 2015 with 2 years of follow-up. All VAs, defined as ventricular fibrillation, ventricular tachycardia lasting >30 s, or a ventricular rhythm requiring defibrillation, were analyzed. VAs occurring within 30 days of implantation were defined as early. Recorded outcomes included death and receipt of cardiac transplant. RESULTS: A total of 517 patients were included for analysis. Early VAs were associated with a significant reduction in survival (hazard ratio: 1.83; 95% confidence interval: 1.28 to 2.61; p = 0.001) compared with patients with late or no VAs. Pre-implantation variables independently predictive of early VAs included prior cardiac surgery (odds ratio: 1.90; 95% confidence interval: 1.09 to 3.32; p = 0.023) and pre-CFLVAD ventricular tachycardia storm (odds ratio: 3.15; 95% confidence interval: 1.49 to 6.69; p = 0.003). The incidence of early VAs from 2000 to 2007 was as high as 47%, whereas the highest incidence from 2008 to 2015 was <22%. CONCLUSIONS: VAs within 30 days after CFLVAD implantation are associated with an increased risk for death. Predictors of early VAs include prior cardiac surgery and pre-CFLVAD ventricular tachycardia storm. Temporal trends have shown a decrease in VA from 2000 to 2015. Strategies to reduce arrhythmia burden shortly after CFLVAD implantation warrant further investigation.

Model of End-Stage Liver Disease-eXcluding International Normalized Ratio (MELD-XI) Scoring System to Predict Outcomes in Patients Who Undergo Left Ventricular Assist Device Implantation.

BACKGROUND: The use of continuous-flow left ventricular assist devices (CF-LVADs) to treat advanced heart failure is increasing. Although risk scores, such as Model for End-Stage Liver Disease and the HeartMate II Risk Score, require the use of the international normalized ratio, many patients are on anticoagulation before CF-LVAD implantation. This study evaluated the ability of the Model of End-Stage Liver Disease-eXcluding International Normalized Ratio (MELD-XI) scoring system to predict clinical outcomes in patients with advanced heart failure who undergo CF-LVAD implantation. METHODS: A single-center retrospective review was performed of 524 patients who were implanted with the HeartMate II LVAD (Thoratec Corporation, Pleasanton, CA) or the HeartWare HVAD (HeartWare International Inc, Framingham, MA) between 2004 and 2016. Patients were stratified into two cohorts: those with a MELD-XI score of less than 14 (n = 301) and 14 or higher (n = 223). RESULTS: Patients with the higher-risk MELD-XI score of 14 or higher demonstrated lower survival rates at 1, 3, 6, 12, and 24 months (p < 0.001 for all) and increased risk of early right heart failure and infections compared with patients with MELD-XI score of less than 14. MELD-XI was not significantly inferior at predicting 90-day mortality compared with the HeartMate II Risk Score (p = 0.92). Patients with elevated MELD-XI scores at follow-up demonstrated higher rates of mortality. CONCLUSIONS: These findings suggest that a MELD-XI score of 14 or higher was associated with a higher postoperative mortality rate than that seen in patients with a lower MELD-XI score. The MELD-XI scoring system can be used to predict outcomes in patients with advanced heart failure who undergo CF-LVAD implantation.

Continuous-Flow Left Ventricular Assist Device Implantation in Patients With a Small Left Ventricle.

BACKGROUND: Having a preoperative small left ventricle (LV) has been associated with higher complication and mortality rates after left ventricular assist device (LVAD) implantation; however, the outcomes after continuous-flow LVAD implantation have not been well studied. This is the first large-scale analysis of long-term survival after continuous-flow LVAD implantation in patients with a preoperative small LV. METHODS: Our cohort comprised 511 patients who underwent primary implantation of a HeartMate II (n = 393 [Thoratec, Pleasanton, CA]) or HeartWare HVAD (n = 118 [HeartWare International, Framingham, MA]) at our institution between November 2003 and March 2016. Preoperative small LV was defined as having an LV end-diastolic diameter of 5.5 cm or less. HeartMate II and HVAD recipients with a small LV were compared with patients not having a small LV in terms of perioperative characteristics, complications, and long-term survival. RESULTS: The HeartMate II was implanted in 393 patients (non-small LV, n = 352; small LV, n = 41), and the HVAD was implanted in 118 patients (non-small LV, n = 94; small LV, n = 24). For the HeartMate II recipients, the 24-month survival rate was 66.8% for the non-small LV patients and 56.1% for the small LV patients (p = 0.17); non-small LV patients had significantly better overall survival (p = 0.02). For the HVAD recipients, the 24-month survival rate was 71.3% for the non-small LV patients and 70.8% for the small LV patients (p = 0.96); these groups showed no significant difference in overall survival (p = 0.89). CONCLUSIONS: Although the indications for implantation are different for these two devices, our study suggests that the survival advantage associated with HVAD implantation should be considered when selecting a device for small LV patients.

Preoperative Prealbumin Level as a Predictor of Outcomes in Patients Who Underwent Left Ventricular Assist Device Implantation.

Malnutrition has been associated with an increased risk of morbidity and mortality in patients who undergo cardiac surgery. However, many measurements of malnutrition have been inadequate prognostic markers. In this study, we sought to determine whether low preoperative serum prealbumin level was associated with morbidity and mortality in patients who underwent continuous-flow left ventricular assist device (CF-LVAD) implantation. From November 2003 to March 2016, 526 patients with chronic heart failure underwent implantation of a CF-LVAD (HeartMate II, n = 403; HeartWare HVAD, n = 123). Our cohort comprised the 317 CF-LVAD recipients whose records included the preoperative serum prealbumin level. These patients were divided into 2 groups: those with a normal preoperative serum prealbumin level (>17 g/dL) and those with hypoprealbuminemia (≤17 g/dL). These groups were then compared with regard to preoperative demographics, incidence of postoperative complications, long-term survival rate, and cause of death. Kaplan-Meier survival analysis revealed that patients with a low preoperative prealbumin level had significantly decreased survival rates at 1, 6, 12, and 24 months (p <0.001) after CF-LVAD implantation and higher overall mortality (p = 0.04) than the patients with a normal prealbumin level, and that exacerbated heart failure made up the majority of this difference within the first 6 months. However, we found no significant correlations between low prealbumin level and postoperative complications. In conclusion, our findings demonstrate that preoperative serum prealbumin levels predict patient outcomes after CF-LVAD implantation.