Impact of time off anticoagulation in patients with continuous-flow left ventricular assist devices.

Patients with left ventricular assist devices (LVADs) receive anticoagulation to decrease the risk of thrombosis. Various circumstances require discontinuing anticoagulation in LVAD patients, but the risks entailed are not well defined. In a retrospective review of LVAD implantation procedures, we examined the effect of time off anticoagulation on thrombosis and mortality rates after implantation. An international normalized ratio ≤ 1.5 was used to screen for patients taken off anticoagulation. Patients were divided into three groups by the cumulative number of days off anticoagulation: no discontinuation, short-term discontinuation (< 30 days), and long-term discontinuation (≥ 30 days). Rates of ischemic stroke, pump thrombosis, and mortality were compared among groups. Of 245 patients who underwent LVAD implantation during the study, 70 (28.6%) were off anticoagulation during follow-up: 37 (15.1%) had short-term discontinuation (median, 11 days), and 33 (13.5%) had long-term discontinuation (median, 124 days). Patients with long-term discontinuation had a higher rate of ischemic stroke (adjusted hazard ratio 8.5, p = 0.001) and death (adjusted hazard ratio 3.9, p = 0.001). The three groups did not differ in pump thrombosis rate. We conclude that after LVAD implantation, discontinuing anticoagulation for ≥ 30 days is independently associated with an increased risk of ischemic stroke and death.

Empagliflozin Effects on Pulmonary Artery Pressure in Patients With Heart Failure: Results From the EMBRACE-HF Trial.

BACKGROUND: Sodium glucose cotransporter 2 inhibitors (SGLT2 inhibitors) prevent heart failure (HF) hospitalizations in patients with type 2 diabetes and improve outcomes in those with HF and reduced ejection fraction, regardless of type 2 diabetes. Mechanisms of HF benefits remain unclear, and the effects of SGLT2 inhibitor on hemodynamics (filling pressures) are not known. The EMBRACE-HF trial (Empagliflozin Evaluation by Measuring Impact on Hemodynamics in Patients With Heart Failure) was designed to address this knowledge gap. METHODS: EMBRACE-HF is an investigator-initiated, randomized, multicenter, double-blind, placebo-controlled trial. From July 2017 to November 2019, patients with HF (regardless of ejection fraction, with or without type 2 diabetes) and previously implanted pulmonary artery (PA) pressure sensor (CardioMEMS) were randomized across 10 US centers to empagliflozin 10 mg daily or placebo and treated for 12 weeks. The primary end point was change in PA diastolic pressure (PADP) from baseline to end of treatment (average PADP weeks 8-12). Secondary end points included health status (Kansas City Cardiomyopathy Questionnaire score), natriuretic peptides, and 6-min walking distance. RESULTS: Overall, 93 patients were screened, and 65 were randomized (33 to empagliflozin, 32 to placebo). The mean age was 66 years; 63% were male; 52% had type 2 diabetes; 54% were in New York Heart Association class III/IV; mean ejection fraction was 44%; median NT-proBNP (N-terminal pro B-type natriuretic peptide) was 637 pg/mL; and mean PADP was 22 mm Hg. Empagliflozin significantly reduced PADP, with effects that began at week 1 and amplified over time; average PADP (weeks 8-12) was 1.5 mm Hg lower (95% CI, 0.2-2.8; P=0.02); and at week 12, PADP was 1.7 mm Hg lower (95% CI, 0.3-3.2; P=0.02) with empagliflozin versus placebo. Results were consistent for PA systolic and PA mean pressures. There was no difference in mean loop diuretic management (daily furosemide equivalents) between treatment groups. No significant differences between treatment groups were observed in Kansas City Cardiomyopathy Questionnaire scores, natriuretic peptide levels, and 6-min walking distance. CONCLUSIONS: In patients with HF and CardioMEMS PA pressure sensor, empagliflozin produced rapid reductions in PA pressures that were amplified over time and appeared to be independent of loop diuretic management. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03030222.

Left Ventricular Unloading During Extracorporeal Life Support: Current Practice.

Venoarterial extracorporeal life support (VA-ECLS) is a powerful tool that can provide complete cardiopulmonary support for patients with refractory cardiogenic shock. However, VA-ECLS increases left ventricular (LV) afterload, resulting in greater myocardial oxygen demand, which can impair myocardial recovery and worsen pulmonary edema. These complications can be ameliorated by various LV venting strategies to unload the LV. Evidence suggests that LV venting improves outcomes in VA-ECLS, but there is a paucity of randomized trials to help guide optimal strategy and the timing of venting. In this review, we discuss the available evidence regarding LV venting in VA-ECLS, explain important hemodynamic principles involved, and propose a practical approach to LV venting in VA-ECLS.

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.

Extracorporeal membrane oxygenation as a bridge to durable left ventricular assist device implantation in INTERMACS-1 patients.

Left ventricular assist devices (LVADs) are increasingly used as destination therapy or as a bridge to future cardiac transplant in patients with end-stage heart failure. Extracorporeal membrane oxygenation (ECMO) can be used to bridge patients in cardiogenic shock or with decompensated heart failure to durable mechanical circulatory support. We assessed outcomes in patients in critical cardiogenic shock (Interagency Registry for Mechanically Assisted Circulatory Support [INTERMACS] profile 1) who underwent implantation of a continuous-flow (CF)-LVAD, with or without preoperative ECMO bridging. For this retrospective study, we selected INTERMACS profile 1 patients who underwent CF-LVAD implantation at our institution between Sep 1, 2004 and Nov 30, 2018. Of 768 patients identified, 133 (17.3%) were INTERMACS profile 1; 26 (19.5%) received preoperative ECMO support, and 107 (80.5%) did not. Postimplantation outcomes were compared between the ECMO and no-ECMO groups. No significant differences were found in 30-day mortality (15.4 vs. 15.9%, P = 0.95) or survival at 1 year (53.8 vs. 60.9%, P = 0.51). Three patients who received ECMO before CF-LVAD implantation subsequently underwent cardiac transplant. In the ECMO group, the lactate level 1 day after ECMO initiation was lower in survivors than nonsurvivors (2.7 ± 2.2 vs. 7.4 ± 4.2 mmol/L, P = 0.02; area under the curve = 0.85, P = 0.01) after CF-LVAD implantation. Bridging with ECMO to CF-LVAD implantation in carefully selected INTERMACS profile 1 patients (those who are at the highest risk for critical cardiogenic shock and for whom palliation may be the only other option) produced acceptable postoperative outcomes.Field of research: Artificial lung/ECMO.

Genetic testing in ambulatory cardiology clinics reveals high rate of findings with clinical management implications.

PURPOSE: Cardiovascular disease (CVD) is the leading cause of death in adults in the United States, yet the benefits of genetic testing are not universally accepted. METHODS: We developed the "HeartCare" panel of genes associated with CVD, evaluating high-penetrance Mendelian conditions, coronary artery disease (CAD) polygenic risk, LPA gene polymorphisms, and specific pharmacogenetic (PGx) variants. We enrolled 709 individuals from cardiology clinics at Baylor College of Medicine, and samples were analyzed in a CAP/CLIA-certified laboratory. Results were returned to the ordering physician and uploaded to the electronic medical record. RESULTS: Notably, 32% of patients had a genetic finding with clinical management implications, even after excluding PGx results, including 9% who were molecularly diagnosed with a Mendelian condition. Among surveyed physicians, 84% reported medical management changes based on these results, including specialist referrals, cardiac tests, and medication changes. LPA polymorphisms and high polygenic risk of CAD were found in 20% and 9% of patients, respectively, leading to diet, lifestyle, and other changes. Warfarin and simvastatin pharmacogenetic variants were present in roughly half of the cohort. CONCLUSION: Our results support the use of genetic information in routine cardiovascular health management and provide a roadmap for accompanying research.

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.

A principal components analysis of factors associated with successful implementation of an LVAD decision support tool.

BACKGROUND: A central goal among researchers and policy makers seeking to implement clinical interventions is to identify key facilitators and barriers that contribute to implementation success. Despite calls from a number of scholars, empirical insights into the complex structural and cultural predictors of why decision aids (DAs) become routinely embedded in health care settings remains limited and highly variable across implementation contexts. METHODS: We examined associations between "reach", a widely used indicator (from the RE-AIM model) of implementation success, and multi-level site characteristics of nine LVAD clinics engaged over 18 months in implementation and dissemination of a decision aid for left ventricular assist device (LVAD) treatment. Based on data collected from nurse coordinators, we explored factors at the level of the organization (e.g. patient volume), patient population (e.g. health literacy; average sickness level), clinician characteristics (e.g. attitudes towards decision aid; readiness for change) and process (how the aid was administered). We generated descriptive statistics for each site and calculated zero-order correlations (Pearson's r) between all multi-level site variables including cumulative reach at 12 months and 18 months for all sites. We used principal components analysis (PCA) to examine any latent factors governing relationships between and among all site characteristics, including reach. RESULTS: We observed strongest inclines in reach of our decision aid across the first year, with uptake fluctuating over the second year. Average reach across sites was 63% (s.d. = 19.56) at 12 months and 66% (s.d. = 19.39) at 18 months. Our PCA revealed that site characteristics positively associated with reach on two distinct dimensions, including a first dimension reflecting greater organizational infrastructure and standardization (characteristic of larger, more established clinics) and a second dimension reflecting positive attitudinal orientations, specifically, openness and capacity to give and receive decision support among coordinators and patients. CONCLUSIONS: Successful implementation plans should incorporate specific efforts to promote supportive and mutually informative interactions between clinical staff members and to institute systematic and standardized protocols to enhance the availability, convenience and salience of intervention tool in routine practice. Further research is needed to understand whether "core predictors" of success vary across different intervention types.

Donor and transplant candidate selection for solid organ transplantation during the COVID-19 pandemic.

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), a novel coronavirus responsible for a worldwide pandemic has forced drastic changes in medical practice in an alarmingly short period of time. Caregivers must modify their strategies as well as optimize the utilization of resources to ensure public and patient safety. For organ transplantation, in particular, the loss of lifesaving organs for transplantation could lead to increased waitlist mortality. The priority is to select uninfected donors to transplant uninfected recipients while maintaining safety for health care systems in the backdrop of a virulent pandemic. We do not yet have a standard approach to evaluating donors and recipients with possible SARS-CoV-2 infection. Our current communication shares a protocol for donor and transplant recipient selection during the coronavirus disease 2019 (COVID-19) pandemic to continue lifesaving solid organ transplantation for heart, lung, liver, and kidney recipients. The initial results using this protocol are presented here and meant to encourage dialogue between providers, offering ideas to improve safety in solid organ transplantation with limited health care resources. This protocol was created utilizing the guidelines of various organizations and from the clinical experience of the authors and will continue to evolve as more is understood about SARS-CoV-2 and how it affects organ donors and transplant recipients.

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 Multisite Randomized Controlled Trial of a Patient-Centered Ventricular Assist Device Decision Aid (VADDA Trial).

BACKGROUND: Studies indicate that decision making and informed consent among patients considering left ventricular assist device (LVAD) support for advanced heart failure could be improved. In the VADDA (Ventricular Assist Device Decision Aid) trial, we tested a patient-centered decision aid (DA) to enhance the quality of decision making about LVAD therapy. METHODS: After an extensive user-centered design process, we conducted a multisite randomized trial of the DA compared with standard education (SE) among inpatients considering LVAD treatment for advanced heart failure The main outcome was LVAD knowledge at 1 week and 1 month after administration of the DA versus the SE, according to a validated scale. Secondary measures included prespecified quality decision making measures recommended by the International Patient Decision Aid Standards collaboration. RESULTS: Of 105 eligible patients, 98 consented and were randomly assigned to the DA and SE arms. Patients receiving the VADDA exhibited significantly greater LVAD knowledge than the SE group at 1 week of follow-up (P = .01) but not at 1 month (P = .47). No differences were found between DA and SE patients in rates of acceptance versus decline of LVAD treatment (85% vs 78%; P = .74). Recipients in the DA arm reported greater satisfaction with life after implantation compared with nonrecipients (28 vs 23 out of 30; P = .008), although both arms reported high satisfaction. Patients rated the DA high in acceptability and usability. CONCLUSIONS: The VADDA enhances LVAD knowledge, particularly in the short term (1 week) during the peak period of decision making. The DA does not encourage decision direction and reflects patient, caregiver, and physician preferences for content and format. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02248974. The trial is registered with clinicaltrials.gov (NCT02248974).

Bridging to a Long-Term Ventricular Assist Device With Short-Term Mechanical Circulatory Support.

Implanting short-term mechanical circulatory support (MCS) devices as a bridge-to-decision is increasingly popular. However, outcomes have not been well studied in patients who receive short-term MCS before receiving long-term left ventricular assist device (LVAD) support. We analyzed outcomes in our single-center experience with long-term continuous-flow (CF)-LVAD recipients with pre-implantation short-term MCS. From November 2003 through March 2016, 526 patients (mean age, 54.7 ± 13.5 years) with chronic heart failure (mean ejection fraction, 21.7 ± 3.6%) underwent implantation of either the HeartMate II (n = 403) or the HeartWare device (n = 123). Before implantation, 269 patients received short-term MCS with the TandemHeart, the Impella 2.5/5.0, an intra-aortic balloon pump (IABP), venoarterial extracorporeal membrane oxygenation (VA-ECMO), or the CentriMag. The short-term MCS patients were compared with the CF-LVAD-only patients regarding preoperative demographics, incidence of postoperative complications, and long-term survival. The 269 patients received the following short-term MCS devices: 57 TandemHeart, 27 Impella, 172 IABP, 12 VA-ECMO, and 1 CentriMag. Survival at 30 days, 6 months, 1 year, and 2 years was 94.2, 87.2, 79.4, and 72.4%, respectively, for CF-LVAD-only patients versus 91.0, 78.1, 73.4, and 65.6%, respectively, for short-term MCS + CF-LVAD patients (P = 0.17). Within the short-term MCS group, survival at 24 months was poorest for patients supported with VA-ECMO or the TandemHeart (P = 0.03 for both), and survival across all four time points was poorest for patients supported with VA-ECMO (P = 0.02). Short-term MCS was not an independent predictor of mortality in multivariate Cox regression models (hazard ratio = 1.12, 95% confidence interval = 0.84-1.49, P = 0.43). In conclusion, we found that using short-term MCS therapy-except for VA-ECMO-as a bridge to long-term CF-LVAD support was not associated with poorer survival.

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.

Outcomes in patients with advanced heart failure and small body size undergoing continuous-flow left ventricular assist device implantation.

Left ventricular assist devices (LVADs) have become a preferred treatment option for patients with end-stage heart failure when used as a bridge to transplant or as a destination therapy. However, the association between small body size and postoperative outcomes for continuous-flow (CF) LVAD recipients is still being studied. We sought to determine whether body surface area (BSA) is associated with patient outcomes after CF-LVAD implantation. The study cohort of our single-center, retrospective review consisted of all patients (n = 526) who underwent CF-LVAD implantation (n = 403 HeartMate II, n = 123 HeartWare) between November 2003 and March 2016 regardless of indication. Patients were stratified into 2 cohorts according to their BSA measurements: small BSA (<1.5 m2, n = 13) and non-small BSA (≥1.5 m2, n = 513). We compared the survival of the small-BSA cohort with that of the non-small-BSA cohort. Patients with a small BSA had lower survival rates at 1, 6, 12, and 24 months (76.9, 61.5, 53.8, and 38.5%, respectively) than did patients with a non-small BSA (90.4, 80.9, 74.7, and 67.6% respectively; overall, p = 0.004). Cox proportional hazard analysis showed that a small BSA was an independent predictor of postoperative mortality (hazard ratio = 0.22, 95% confidence interval = 0.05-0.97, p < 0.04). These findings highlight the adverse impact of a small BSA on outcomes after CF-LVAD implantation.

Effect of obesity on outcomes in patients undergoing implantation of continuous-flow left ventricular assist devices.

The purpose of this study was to analyze the effect of obesity on outcomes after continuous-flow left ventricular assist device (CF-LVAD) implantation. A single-center retrospective analysis was performed on 526 chronic heart failure patients who were implanted with the HeartMate II CF-LVAD (n = 403) or HeartWare HVAD (n = 123) between November 2003 and March 2016. Patients were stratified into 4 groups based on BMI: underweight (< 18.5 kg/m2, n = 18, 3.4%), normal-weight (18.5-25 kg/m2, n = 173, 32.9%), overweight (25-30 kg/m2, n = 182, 30.2%), and obese (> 30 kg/m2, n = 153, 33.5%). The underweight group was excluded because of its small sample size. Records were reviewed to determine the incidence of postoperative complications and survival. Survival at 1, 6, 12, and 24 months were similar among normal-weight (91.3, 84.4, 76.3, and 67.6%), overweight (90.4, 80.8, 76.5, and 69.6%), and obese patients (90.7, 74.7, 65.3, and 61.3%, p = 0.24). Additionally, obesity was not a significant predictor of mortality in Cox proportional hazard models (hazard ratio 0.98, 95% confidence interval 0.766-1.277, p = 0.13). These findings suggest that appropriately selected obese patients receive similar survival benefit from CF-LVADs compared to non-obese patients, and obesity should not serve as a contraindication to CF-LVAD implantation.

Acute kidney injury after implantation of a left ventricular assist device: a comparison of axial-flow (HeartMate II) and centrifugal-flow (HeartWare HVAD) devices.

Continuous-flow left ventricular assist devices (CF-LVADs) are increasingly being used to treat advanced, refractory chronic heart failure. Herein, we sought to determine the incidence of postoperative acute kidney injury (AKI) in axial-flow (HeartMate II; HM-II) and centrifugal-flow (HVAD) CF-LVAD recipients, as well as the effect of AKI on mortality. The study cohort comprised 520 patients who received a HM-II (n = 398) or HVAD (n = 122) at our center between November 2003 and March 2016. Their records were reviewed to determine the incidence of RIFLE-defined AKI after LVAD implantation. We compared the perioperative characteristics, postoperative complications, and survival rates of the patients with and without AKI and differentiated the outcomes based on device type (HM-II or HVAD). Seventy-five patients (14.4%) developed AKI postoperatively. Patients with AKI after LVAD implantation had significantly reduced survival compared to patients without AKI (p = 0.01). Cox proportional hazards models showed that AKI was a significant independent predictor of mortality (HR = 1.54, p = 0.03). Preoperative mechanical circulatory support and prolonged cardiopulmonary bypass time were independent predictors of AKI. The incidence of AKI was similar for HM-II and HVAD recipients (p = 0.25). There was no significant difference in AKI rates for the HM-II and HVAD recipients. Developing AKI adversely affected survival.

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.

Left ventricular outflow tract closure during LVAD implantation: 2 cases of patients supported for over 6 years.

We previously reported a series of 5 patients with advanced heart failure and aortic insufficiency (AI) who underwent concomitant left ventricular outflow tract (LVOT) closure at the time of continuous-flow left ventricular assist device (CF-LVAD) implantation. Although this technique of treating AI has been shown to be effective in the short term, its long-term durability has not been well studied. Here, we report the long-term outcomes of two patients with severe AI who underwent LVOT closure at the time of CF-LVAD implantation. Each of the two patients survived for more than 6 years without any complications related to LVOT closure.

Total artificial heart implantation for biventricular failure due to eosinophilic myocarditis.

Idiopathic hypereosinophilic syndrome is a condition of unknown etiology characterized by proliferation of eosinophils and their infiltration into tissues. Although cardiac involvement is rare, eosinophilic myocarditis can lead to life-threating fulminant congestive heart failure. Treatment of patients with eosinophilic myocarditis is challenging as heart failure can be caused by biventricular dysfunction. To our knowledge, this is the first case reported in the literature describing a patient with acute severe biventricular heart failure caused by eosinophilic myocarditis with mural left ventricular apical thrombus who was successfully treated with implantation of a total artificial heart as a bridge to heart transplant.

The current use of Impella 2.5 in acute myocardial infarction complicated by cardiogenic shock: results from the USpella Registry.

OBJECTIVES: To evaluate the periprocedural characteristics and outcomes of patients supported with Impella 2.5 prior to percutaneous coronary intervention (pre-PCI) versus those who received it after PCI (post-PCI) in the setting of cardiogenic shock (CS) complicating an acute myocardial infarction (AMI). BACKGROUND: Early mechanical circulatory support may improve outcome in the setting of CS complicating an AMI. However, the optimal timing to initiate hemodynamic support has not been well characterized. METHODS: Data from 154 consecutive patients who underwent PCI and Impella 2.5 support from 38 US hospitals participating in the USpella Registry were included in our study. The primary end-point was survival to discharge. Secondary end-points included assessment of patients' hemodynamics and in-hospital complications. A multivariate regression model was used to identify independent predictors for mortality. RESULTS: Both groups were comparable except for diabetes (P = 0.02), peripheral vascular disease (P = 0.008), chronic obstructive pulmonary disease (P = 0.05), and prior stroke (P = 0.04), all of which were more prevalent in the pre-PCI group. Patients in the pre-PCI group had more lesions (P = 0.006) and vessels (P = 0.01) treated. These patients had also significantly better survival to discharge compared to patients in the post-PCI group (65.1% vs.40.7%, P = 0.003). Survival remained favorable for the pre-PCI group after adjusting for potential confounding variables. Initiation of support prior to PCI with Impella 2.5 was an independent predictor of in-hospital survival (Odds ratio 0.37, 95% confidence interval: 0.17-0.79, P = 0.01) in multivariate analysis. The incidence of in-hospital complications included in the secondary end-point was similar between the 2 groups. CONCLUSIONS: The results of our study suggest that early initiation of hemodynamic support prior to PCI with Impella 2.5 is associated with more complete revascularization and improved survival in the setting of refractory CS complicating an AMI.