Right Ventricular Contractility and Pulmonary Arterial Coupling After Less Invasive Left Ventricular Assist Device Implantation.

Right ventricular failure contributes significantly to morbidity and mortality after left ventricular assist device implantation. Recent data suggest a less invasive strategy (LIS) via thoracotomy may be associated with less right ventricular failure than conventional median sternotomy (CMS). However, the impact of these approaches on load-independent right ventricular (RV) contractility and RV-pulmonary arterial (RV-PA) coupling remains uncertain. We hypothesized that the LIS approach would be associated with preserved RV contractility and improved RV-PA coupling compared with CMS. We performed a retrospective study of patients who underwent durable, centrifugal left ventricular assist device implantation and had paired hemodynamic assessments before and after implantation. RV contractility (end-systolic elastance [Ees]), RV afterload (pulmonary effective arterial elastance [Ea]), and RV-PA coupling (Ees/Ea) were determined using digitized RV pressure waveforms. Forty-two CMS and 21 LIS patients were identified. Preimplant measures of Ees, Ea, and Ees/Ea were similar between groups. After implantation, Ees declined significantly in the CMS group (0.60-0.40, p = 0.008) but not in the LIS group (0.67-0.58, p = 0.28). Coupling (Ees/Ea) was unchanged in CMS group (0.54-0.59, p = 0.80) but improved significantly in the LIS group (0.58-0.71, p = 0.008). LIS implantation techniques may better preserve RV contractility and improve RV-PA coupling compared with CMS.

Changing Strategy Between Bridge to Transplant and Destination LVAD Therapy After the First 3 Months: Analysis of the STS-INTERMACS Database.

BACKGROUND: Left ventricular assist devices (LVADs) have been implanted as bridge to transplantation (BTT), bridge to candidacy (BTC) or destination therapy (DT) on the basis of relative and absolute contraindications to transplantation. Multiple factors may lead to changes in the strategy of support after LVAD implantation. METHODS: Based on INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) 2012-2020 data, 11,262 patients survived to 3 months on continuous-flow LVADs with intent of BTT or DT. Preimplant characteristics and early events post-LVAD were analyzed in relation to changes in BTT or DT strategy during the next 12 months. RESULTS: Among 3216 BTT patients at 3 months, later transplant delisting or death without transplant occurred in 536 (16.7%) and was more common with age, profiles 1-2, renal dysfunction, and independently for prior cardiac surgery (HR 1.25, 95% CI 1.04-1.51; P = 0.02). Post-LVAD events of infections, gastrointestinal bleeding, stroke, and right heart failure as defined by inotropic therapy, predicted delisting and death, as did in-hospital location at 3 months (HR 1.67, 95% CI 1.20-2.33; P = 0.0024). Of 8046 patients surviving to 3 months with the intent of destination therapy, 750 (9.3%) subsequently underwent listing or transplantation, often with initial histories of acute HF (HR 1.70, 95% CI 1.27-2.27; P = 0.0012) or malnutrition-cachexia (1.73, 95% CI 1.14-2.63; P = 0.0099). Multiple gastrointestinal bleeding events (≥ 4) with LVAD increased transition from BTT to DT (HR 4.22, 95% CI 1.46-12.275; P = 0.0078) but also from DT to BTT (HR 5.17, 95% CI 1.92-13.9; P = 0.0011). CONCLUSIONS: Implant strategies change over time in relation to preimplant characteristics and adverse events post implant. Preimplant recognition of factors predicting later change in implant strategy will refine initial triage, whereas further reduction of post-LVAD complications will expand options, including eventual consideration of heart transplantation.

Cardio-Obstetric Shock: Mechanical Circulatory Support as a Bridge to Pregnancy Viability.

Cardiogenic shock in pregnancy is rare but is associated with significant morbidity and mortality. Timely recognition with multidisciplinary management is necessary for optimal maternal and fetal outcomes. Here we present a case of cardiogenic shock in the antepartum period managed with mechanical circulatory support as a bridge to pregnancy viability.

Outcomes of Combined Heart-Kidney Transplantation in Older Recipients.

Objectives: The upper limit of recipient age for combined heart-kidney transplantation (HKT) remains controversial. This study evaluated the outcomes of HKT in patients aged ≥65 years. Methods: The United Network of Organ Sharing (UNOS) was used to identify patients undergoing HKT from 2005 to 2021. Patients were stratified by age at transplantation: <65 and ≥ 65 years. The primary outcome was one-year mortality. Secondary outcomes included 90-day and 5-year mortality, postoperative new-onset dialysis, postoperative stroke, acute rejection prior to discharge, and rejection within one-year of HKT. Survival was compared using Kaplan-Meier analysis, and risk adjustment for mortality was performed using Cox proportional hazards modeling. Results: HKT in recipients aged ≥65 significantly increased from 5.6% of all recipients in 2005 to 23.7% in 2021 (p=0.002). Of 2,022 HKT patients in the study period, 372 (18.40%) were aged ≥65. Older recipients were more likely to be male and white, and fewer required dialysis prior to HKT. There were no differences between cohorts in unadjusted 90-day, 1-year, or 5-year survival in Kaplan-Meier analysis. These findings persisted after risk-adjustment, with an adjusted hazard for one-year mortality for age ≥65 of 0.91 (95% CI (0.63-1.29), p=0.572). As a continuous variable, increasing age was not associated with one-year mortality (HR 1.01 (95% CI (1.00-1.02), p=0.236) per year). Patients aged ≥65 more frequently required new-onset dialysis prior to discharge (11.56% vs. 7.82%, p=0.051). Stroke and rejection rates were comparable. Conclusion: Combined HKT is increasing in older recipients, and advanced age ≥65 should not preclude HKT.

Impact of Donor Hemodynamics on Recipient Survival in Heart Transplantation.

BACKGROUND: Heart transplantation is the gold-standard therapy for end-stage heart failure, but rates of donor-heart use remain low due to various factors that are often not evidence based. The impact of donor hemodynamics obtained via right-heart catheterization on recipient survival remains unclear. METHODS: The United Network for Organ Sharing registry was used to identify donors and recipients from September 1999-December 2019. Donor hemodynamics data were obtained and analyzed using univariate and multivariable logistical regression, with the primary endpoints being 1- and 5-year post-transplant survival. RESULTS: Of the 85,333 donors who consented to heart transplantation during the study period, 6573 (7.7%) underwent right-heart catheterization, of whom 5531 eventually underwent procurement and transplantation. Donors were more likely to undergo right-heart catheterization if they had high-risk criteria. Recipients who had donor hemodynamic assessment had 1- and 5-year survival rates similar to those without donor hemodynamic assessment (87% vs 86%, 1 year). Abnormal hemodynamics were common in donor hearts but did not impact recipient survival rates, even when risk-adjusted in multivariable analysis. CONCLUSIONS: Donors with abnormal hemodynamics may represent an opportunity to expand the pool of viable donor hearts.

The HeartMate 3 left ventricular assist device as a strategy to bridge to transplant.

PURPOSE: Recent changes in the market for left ventricular assist devices have resulted in the HeartMate 3 (HM3) being the only commercially-available device. This study evaluates the outcomes of patients with a HM3 waitlisted for and undergoing orthotopic heart transplantation (OHT). METHODS: Patients waitlisted for isolated OHT with a HM3 or undergoing OHT after bridge-to-transplant (BTT) with a HM3 between 2015 and 2021 were identified from the UNOS registry and included in this study. Propensity matching was used to compare outcomes of BTT-HM3 versus primary OHT. RESULTS: A total of 1321 patients supported with a HM3 underwent OHT during our study period. Unadjusted 30-day, 90-day, and 1-year survival following OHT in the BTT-HM3 cohort was 96.5%, 94.4%, and 90.7%, respectively. In propensity-matched analysis, 1103 BTT-HM3 patients were compared with 1103 primary OHT patients. Rates of post-OHT stroke were higher in the BTT-HM3 group (4.4% vs. 2.0%, p = .001). The BTT-HM3 group had lower 30-day survival (96.2% vs. 97.4%, p = .033) although 90-day (94.2% vs. 95.3%, p = .103) and 1-year survival (90.4% vs. 91.7%, p = .216) were comparable. A total of 1251 patients were supported with a HM3 at the time of OHT listing during the study period. At the time of this analysis, 60 (4.5%) remained on the waitlist, 991 (75.0%) underwent OHT, and 119 (9.0%) died or clinically deteriorated with waitlist removal. CONCLUSIONS: The HM3 is a viable method for BTT with acceptable waitlist outcomes. Although 1-year survival is comparable to primary OHT, early outcomes are worse, suggesting that refinement of patient selection and perioperative management is prudent to optimizing outcomes.

Sex mismatch following heart transplantation in the United States: Characteristics and impact on outcomes.

BACKGROUND: Available literature indicates the possible detrimental effect of sex mismatching on mortality in patients undergoing heart transplantation. Our objective was to examine the role of sex and heart mass (predicted heart mass [PHM]) mismatch on mortality and graft rejection in patients undergoing heart transplantation in the US. METHODS: Data on adult patients who underwent heart transplantation between January 2015 and October 2021 were queried from the United Network of Organ Sharing (UNOS) registry. The main outcomes were all-cause mortality, 1-year all-cause mortality and treated acute rejection. RESULTS: A total of 19 805 adult patients underwent heart transplant during the study period. 92.2% of the patients in the female graft to male group had a PHM mismatch <25%, while only 38.5% had such a mismatch in the male graft to female group. In male to male and female to female groups, 79% and 76% of the patients had a PHM mismatch <25% (p = .122). Proportion of PHM mismatch was similar throughout the study period. Unadjusted analysis showed that male recipients of female grafts had increased risk for all-cause mortality (hazard ratio [HR]: 1.13; 95% confidence intervals [CI]: 1.02, 1.27; p = .026) and 1-year mortality (HR: 1.26; 95% CI: 1.09, 1.45; p = .002) compared to male recipients of male grafts. Graft failure incidence was also higher (HR: 1.12; 95% CI: 1.01, 1.25; p = .041). However, all these associations were non- significant after risk factor adjustment. CONCLUSIONS: Sex mismatching is associated with post-transplant mortality with transplantation of female donor grafts to male recipients demonstrating worse outcomes, although this association disappears after risk factor adjustment. Further research is required to elucidate the need for potential changes in clinical practice.

Hemodynamic reserve predicts early right heart failure after LVAD implantation.

BACKGROUND: Early right heart failure (RHF) remains a major source of morbidity and mortality after left ventricular assist device (LVAD) implantation, yet efforts to predict early RHF have proven only modestly successful. Pharmacologic unloading of the left ventricle may be a risk stratification approach allowing for assessment of right ventricular and hemodynamic reserve. METHODS: We performed a multicenter, retrospective analysis of patients who had undergone continuous-flow LVAD implantation from October 2011 to April 2020. Only those who underwent vasodilator testing with nitroprusside during their preimplant right heart catheterization were included (n = 70). Multivariable logistic regression was used to determine independent predictors of early RHF as defined by Mechanical Circulatory Support-Academic Research Consortium. RESULTS: Twenty-seven patients experienced post-LVAD early RHF (39%). Baseline clinical characteristics were similar between patients with and without RHF. Patients without RHF, however, achieved higher peak stroke volume index (SVI) (30.1 ± 8.8 vs 21.7 ± 7.4 mL/m2; p < 0.001; AUC: 0.78; optimal cut-point: 22.1 mL/m2) during nitroprusside administration. Multivariable analysis revealed that peak SVI was significantly associated with early RHF, demonstrating a 16% increase in risk of early RHF per 1 ml/m2 decrease in SVI. A follow up cohort of 10 consecutive patients from July 2020 to October 2021 resulted in all patients being categorized appropriately in regards to early RHF versus no RHF according to peak SVI. CONCLUSION: Peak SVI with nitroprusside administration was independently associated with post-LVAD early RHF while resting hemodynamics were not. Vasodilator testing may prove to be a strong risk stratification tool when assessing LVAD candidacy though additional prospective validation is needed.

Characteristics and outcomes of left ventricular assist device recipients transplanted before and after the new donor heart allocation system.

BACKGROUND: Concerns about the impact of the new donor heart allocation system on posttransplant outcomes have emerged after its implementation. We sought to evaluate the characteristics and outcomes of left ventricular assist device (LVAD) recipients transplanted before and after the implantation of the new policy on October 18, 2018. METHODS: Data on bridge to transplantation of adult patients with LVAD between January 2015 and October 2021, with durable LVAD as a (BTT), was queried from the United Network of Organ Sharing (UNOS) registry. The main outcomes were 30-day all-cause mortality, 30-day fatal graft failure, 1-year all-cause mortality, treated acute rejection at 1 year and renal replacement therapy (RRT) for acute renal failure. RESULTS: In our study, 7096 patients met the inclusion criteria including 2435 in the new allocation system. The transplanted patients in the new allocation system era had older donor age, longer ischemic time, and higher proportion of newer generation LVADs. Adjusted 30-day all-cause mortality was significantly lower for LVAD recipients in the new allocation system era (2.5% vs. 3.6%; sub-hazard ratio [SHR] 0.36, 95% Confidence intervals [CI] 0.27-0.48, p < 0.001) without differences in the risk of fatal graft failure and 1-year mortality (7.8% vs. 9.6%). Significantly lower adjusted 30-day mortality with HVAD and HM3 devices than HM2 in the new allocation system era was found, without differences in 1-year mortality. Acute allograft rejection requiring treatment was significantly lower (Odds Ratio 0.78, 95% CI 0.65-0.94, p = 0.01), whereas a trend toward higher risk of renal failure requiring RRT was identified. CONCLUSIONS: Despite changing donor characteristics and longer ischemic times, posttransplant outcomes in LVAD recipients have not worsened with the implementation of the new allocation system and this finding is related to the use of newer generation continuous flow LVADs.

Outcomes in Patients With LVADs Undergoing Simultaneous Heart-Kidney Transplantation.

BACKGROUND: Multiple studies have shown better outcomes for simultaneous heart-kidney transplant (sHKT) than for isolated orthotopic heart transplant (iOHT) in recipients with chronic kidney disease (CKD). However, outcomes in patients supported by durable left ventricular assist devices (LVADs) have not been well studied. METHODS: Patients with durable LVADs and stage 3 or higher CKD (eGFR < 60 mL/min/1.73 m2) undergoing iOHT or sHKT between 2008 and 2020 were identified from the United Network for Organ Sharing registry. A Kaplan-Meier survival analysis with associated log-rank test was conducted to compare post-transplant survival rates. Multivariable modeling was used to identify risk-adjusted predictors of 1 year post-transplant mortality. RESULTS: We identified 4375 patients; 366 underwent sHKT, and 4009 underwent iOHT. The frequency of sHKT increased during the study period. The 1-year post-transplant survival rate was worse in patients after sHKT than in patients after iOHT (80.3% vs 88.3%; P < 0.001) and persisted up to 5 years post-transplant (P = 0.001). sHKT recipients were more likely to require dialysis after transplantation and had longer hospital lengths of stay (P < 0.001). Multivariable analysis showed that sHKT remained an independent risk factor for mortality at 1 year (OR 1.58; P = 0.002). CONCLUSIONS: sHKT is becoming more common in patients with durable LVADs. Compared with iOHT, patients with sHKTs have worse short- and long-term survival rates and are more likely to require post-transplant dialysis.

Hemodynamic and Clinical Determinants of Left Atrial Enlargement in Liver Transplant Candidates.

New-onset heart failure is a frequent complication after orthotopic liver transplantation (OLT). Left atrial enlargement (LAE) may be a sign of occult left heart disease. Our primary objective was to determine invasive hemodynamic and clinical predictors of LAE and then investigate its effect on post-transplant outcomes. Of 609 subjects who received OLT between January 1, 2010, and October 1, 2018, 145 who underwent preoperative right-sided cardiac catheterization and transthoracic echocardiography were included. Seventy-eight subjects (54%) had pretransplant LAE. Those with LAE had significantly lower systemic vascular resistance with higher cardiac and stroke volume index (61.0 vs 51.7 ml/m2; p <0.001), but there was no difference in pulmonary artery wedge pressure. There was a linear relation between left atrial volume index and stroke volume index (R2 = 0.490, p<0.001), but not pulmonary artery wedge pressure. The presence of severe LAE was associated with a reduced likelihood (hazard ratio = 0.26, p = 0.033) of reaching the composite end point of new-onset systolic heart failure, heart failure hospitalization, or heart failure death within 12 months post-transplant. There was also a significant reduction in LAE after transplantation (p = 0.013). In conclusion, LAE was common in OLT recipients and was more closely associated with stroke volume than left heart filling pressures. The presence of LAE was associated with a reduced likelihood of reaching composite outcomes and tended to regress after transplant.

The impact of changes in renal function during waitlist time on outcomes after heart transplantation.

BACKGROUND AND AIM: This study evaluated the impact of changes in renal function during the waitlist period on posttransplant outcomes of orthotopic heart transplantation (OHT). METHODS: The United Network for Organ Sharing registry was used to identify adult patients undergoing isolated OHT from 2010 to 2020. Patients were stratified by whether their National Kidney Foundation chronic kidney disease (CKD) stage improved, worsened, or remained unchanged between listing and transplantation. Univariate analysis and multivariable Cox regression were conducted to determine whether a change in estimated glomerular filtration rate (eGFR) or change in CKD stage predicted 1-year mortality after OHT. RESULTS: Of 22,746 patients, the majority of patients remained in the same CKD stage (59.6%), and the frequencies of patients progressing to improved (19.3%) and worsened (21.1%) CKD stages were similar. Temporary mechanical circulatory support (MCS) was associated with improved CKD stage and durable MCS with worsened CKD stage (p < .001). Post-OHT dialysis was most common in patients with worsened CKD stage (13.2%) and least common in the improved cohort (9.4%) (p < .001). Kaplan-Meier unadjusted 1-year survival rates after OHT were similar between CKD change groups (log-rank p = .197). Multivariable analysis demonstrated no risk-adjusted effect of change in eGFR (p = .113) or change in CKD stage (p = .076) on 1-year mortality after OHT. CONCLUSIONS: Approximately 20% of patients improve CKD stage and 20% worsen CKD stage between listing and OHT, with the remaining 60% having unchanged CKD stage. Worsening CKD stage predicts increased likelihood of post-OHT dialysis, but CKD stage change does not predict 1-year survival following OHT.

Pulmonary Hypertension in the Context of Heart Failure With Preserved Ejection Fraction.

Heart failure with preserved ejection fraction (HFpEF) is the most common form of heart failure and frequently is associated with pulmonary hypertension (PH). HFpEF associated with PH may be difficult to distinguish from precapillary forms of PH, although this distinction is crucial because therapeutic pathways are divergent for the two conditions. A comprehensive and systematic approach using history, clinical examination, and noninvasive and invasive evaluation with and without provocative testing may be necessary for accurate diagnosis and phenotyping. After diagnosis, HFpEF associated with PH can be subdivided into isolated postcapillary pulmonary hypertension (IpcPH) and combined postcapillary and precapillary pulmonary hypertension (CpcPH) based on the presence or absence of elevated pulmonary vascular resistance. CpcPH portends a worse prognosis than IpcPH. Despite its association with reduced functional capacity and quality of life, heart failure hospitalizations, and higher mortality, therapeutic options focused on PH for HFpEF associated with PH remain limited. In this review, we aim to provide an updated overview on clinical definitions and hemodynamically characterized phenotypes of PH, pathophysiologic features, therapeutic strategies, and ongoing challenges in this patient population.

Treatment of right ventricular dysfunction and heart failure in pulmonary arterial hypertension.

Right heart dysfunction and failure is the principal determinant of adverse outcomes in patients with pulmonary arterial hypertension (PAH). In addition to right ventricular (RV) dysfunction, systemic congestion, increased afterload and impaired myocardial contractility play an important role in the pathophysiology of RV failure. The behavior of the RV in response to the hemodynamic overload is primarily modulated by the ventricular interaction and its coupling to the pulmonary circulation. The presentation can be acute with hemodynamic instability and shock or chronic producing symptoms of systemic venous congestion and low cardiac output. The prognostic factors associated with poor outcomes in hospitalized patients include systemic hypotension, hyponatremia, severe tricuspid insufficiency, inotropic support use and the presence of pericardial effusion. Effective therapeutic management strategies involve identification and effective treatment of the triggering factors, improving cardiopulmonary hemodynamics by optimization of volume to improve diastolic ventricular interactions, improving contractility by use of inotropes, and reducing afterload by use of drugs targeting pulmonary circulation. The medical therapies approved for PAH act primarily on the pulmonary vasculature with secondary effects on the right ventricle. Mechanical circulatory support as a bridge to transplantation has also gained traction in medically refractory cases. The current review was undertaken to summarize recent insights into the evaluation and treatment of RV dysfunction and failure attributable to PAH.

The impact of insurance type on listing status and wait-list mortality of patients with left ventricular assist devices as bridge to transplantation.

AIMS: Adequate health insurance coverage is necessary for heart transplantation (HT) candidates. Prior studies have suggested inferior outcomes post HT with public health insurance. We sought to evaluate the effects of insurance type on transplantation rates, listing status and mortality prior to HT. METHODS AND RESULTS: Patients ≥18 years old with a left ventricular assist device implanted and listed with 1A status were identified in the United Network for Organ Sharing registry between January 2010 and December 2017, with follow-up through March 2018. Patients were grouped based on the type of insurance private/self-pay (PV), Medicare (MC), and Medicaid (MA) at the time of listing. We conducted multivariable competing risks regression analysis on listing status and mortality on the waiting list, stratified by insurance type at the time of listing. We identified 2604 patients listed in status 1A (PV: 51.4%, MC: 32.1%, and MA: 16.5%). MA patients were younger (43.5 vs. 56.4 for MC vs. 51.5 for PV, P < 0.001) and less frequently White (P < 0.001). The cumulative incidence of HT did not differ among the three insurance types (PV: 74.8%, MC 76.3%, and MA 71.1%, P = 0.14). The cumulative mortality on the waiting list prior to HT was not different among groups (PV: 29.3%, MC 26.3%, and MA 21.8%, P = 0.94). Μore patients with MA were removed from the list because of improvement of their condition (MA 40.3% vs. MC 28.3% and PV 32.8%). CONCLUSIONS: We did not detect any disparities in listing status and mortality among different insurance types.

Characteristics and outcomes in patients with atrial fibrillation receiving direct oral anticoagulants in off-label doses.

BACKGROUND: We evaluated adherence to dosing criteria for patients with atrial fibrillation (AF) taking dabigatran or rivaroxaban and the impact of off-label dosing on thromboembolic and bleeding risk. METHODS: We used data for a retrospective cohort from a large U.S. health plan for Medicare beneficiaries age > =65 years with AF who initiated dabigatran or rivaroxaban during 2010-2016. Stroke and major bleeding were quantified in patients who were eligible for low dose but received standard dose, and in patients who were eligible for standard dose but received low dose. RESULTS: We identified 8035 and 19,712 patients who initiated dabigatran or rivaroxaban, respectively. Overall, 1401 (17.4%) and 7820 (39.7%) patients who received dabigatran and rivaroxaban met criteria for low dose, respectively. Of those, 959 (68.5%) and 3904 (49.9%) received standard dose. In contrast, 1013 (15.3%) and 2551 (21.5%) of patients eligible for standard dose dabigatran and rivaroxaban received low dose. Mean follow-up for patients eligible for low and standard dose dabigatran and rivaroxaban were 13.9, 15.1, 10.1, and 12.3 months, respectively. In unadjusted analyses, patients eligible for low or standard dose dabigatran and rivaroxaban but receiving off-label dose, had no differences in the rates of ischemic stroke. Among patients who met criteria for standard dose direct oral anticoagulants (DOAC), use of low dose was associated with significantly higher risk of any major bleeding (Dabigatran: HR = 1.44; 95% CI 1.14-1.8, P = 0.002, Rivaroxaban HR 1.34, 95% CI 1.11-1.6, P = 0.002) and gastrointestinal bleeding (Dabigatran: HR = 1.48; 95% CI 1.08-2, P = 0.016). In patients who met criteria for low dose DOACs, there was lower risk of major bleeding (Dabigatran: HR = 0.59; 95% CI 0.43-0.8, P < 0.001), gastrointestinal (Rivaroxaban: HR 0.79; 95% CI 0.64-0.98, P = 0.03) and intracranial bleeding (Dabigatran: HR = 0.33; 95% CI 0.12-0.9, P = 0.001) with standard dosing. After propensity matching, use of off-label doses was not associated with stroke, major, gastrointestinal or intracranial bleeding for either dabigatran or rivaroxaban. CONCLUSIONS: While a significant number of patients receive higher or lower dose of dabigatran and rivaroxaban than recommended, we found no evidence of significant impact on thromboembolic or hemorrhagic outcomes.

Trends in utilization, mortality, major complications, and cost after total artificial heart implantation in the United States (2009-2015).

OBJECTIVE: Total artificial heart (TAH) is a viable bridge to transplant (BTT) strategy for patients with severe biventricular failure or complex congenital heart disease. These patients have higher mortality and morbidity than patients undergoing left ventricular assist device (LVAD) implantation. To assess national trends in in-hospital mortality, major complications, cost, length of stay, and disposition of patients undergoing TAH implantation. METHODS: Data from the National Inpatient Sample, the largest all-payer inpatient data set in the United States, and the US Census Bureau, for the years 2009 to 2015 were analyzed. Participants included all adult patients who received TAH from 2009 to 2015. Endpoints included in-hospital mortality, in-hospital complications, heart transplantation (HT) in the same admission, length of stay, cost, and disposition at the time of discharge. RESULTS: We identified a total of 143 (weighted = 703) TAH implantations. The number of TAH implants increased during the study period (average annual change +5.8%, p = 0.03). Rates of in-hospital mortality and major complications including ischemic stroke, major bleeding, postoperative infections, acute kidney injury requiring dialysis, and HT did not change significantly over the study period. Although the length of stay and disposition patterns did not change over time, we found a significant increase in cost of hospitalization (average annual change +44,362, p = 0.01). The number of HT during the same hospital stay decreased significantly (average annual change -8.1%, p = 0.02). CONCLUSION: In-hospital mortality and complication rates associated with TAH implantation remain increased and did not change in the era of continuous flow LVADs.

Management of Patients with Heart Failure: Focus on New Pharmaceutical and Device Options.

Hospitalization rates and survival of patients with Heart Failure (HF) have improved. However, 5-year mortality rates remain high and the prevalence of the disease is rising likely due to aging of the population and advances in diagnosis and treatment of other acute and chronic cardiovascular diseases. Over the past three decades the therapeutic armamentarium of heart failure has improved substantially with development of medications targeting neuro-hormonal activation and devices preventing sudden cardiac death and improving cardiac synchrony. Recently, inhibition of angiotensin receptors and neprilysin as well as sinoatrial pacemaker modulating f-current, have been found safe and effective strategies that improve HF hospitalization rates and/or mortality. Antidiabetic agents inhibiting sodium-glucose co-transporters 2, result in natriuresis and osmotic diuresis and may further improve HF related outcomes. Furthermore, emerging therapies such as cardiac myosin activators, soluble guanylate cyclase stimulators and non-steroidal mineralocorticoid receptor antagonists are undergoing investigation in phase II and III studies of HF patients. Finally, rapid evolution of in the management of advanced HF has occurred with the application of second and third generation continuous flow left ventricular assist devices in clinical practice. Ongoing clinical studies will validate the safety and efficacy of emerging therapeutic strategies in HF population underrepresented in previous clinical trials.

Gender Differences in Outcomes After Implantation of Left Ventricular Assist Devices.

BACKGROUND: Left ventricular assist device (LVAD) implantation has historically been underutilized in women compared with men. It was hypothesized that the introduction of continuous-flow LVADs would lead to more LVAD implantations in women and possibly narrow the gender gap. METHODS: Patients who underwent LVAD implantation between 2009 and 2014 were identified using the national inpatient sample. RESULTS: A total of 3511 patients (17,251 when weighted) underwent LVAD implantation in the United States between 2009 and 2014. Mean age was 56 years and there were 817 women in the study sample (23.32%). LVAD implantations in women doubled from 2009 to 2014, but men continued to receive LVAD 3 times more than women. Inpatient mortality after LVAD placement was similar between men and women (13.42% women vs 12.85% men; odds ratio, 1.05; P = .16). Most common complications after LVAD implantation in both genders included acute kidney injury, bleeding requiring blood transfusion, and postoperative sepsis. There were no gender-specific differences in the incidence of periprocedural complications, including postoperative cardiac tamponade, postoperative thromboembolism, or sepsis. In addition, no significant difference was found in length of stay and median hospitalization cost. The use of extracorporeal membrane oxygenation did not differ between men and women. Subgroup analysis in patients older than 65 years of age showed higher in-hospital mortality but no differences between genders. CONCLUSIONS: The number of women undergoing LVAD implantation has increased with the introduction of continuous-flow LVADs, but a gender gap still exists. Most major in-hospital outcomes after LVAD implantation are similar between genders.

Trends, Outcomes, and Readmissions Among Left Ventricular Assist Device Recipients with Acute Kidney Injury Requiring Hemodialysis.

Although renal function may improve after left ventricular assist devices (LVAD) implantation, acute kidney injury (AKI) requiring hemodialysis (HD) therapy can occur postoperatively. We used data from the National Readmissions Database to calculate annual rates of in-hospital outcomes and readmissions among patients who underwent implantation and developed acute kidney injury (AKI) requiring hemodialysis (HD) for years 2012-2015. We identified 178 (weighted 469) patients with AKI requiring HD after LVAD implantation. In-hospital mortality was significantly higher among LVAD recipients who required HD for AKI compared with those who did not (42.38% vs. 8.38%, p < 0.001). Rates of in-hospital mortality (from 52.1% in 2012 to 33.9% in 2014, p = 0.046) and length of stay (from 60.3 days in 2012 to 47.1 days in 2014, p = 0.003) decreased significantly, whereas there was a trend toward reduced hospital cost (from $320,414 in 2012 to $267,285 in 2014, p = 0.076) during the study period. However, postoperative bleeding increased significantly (p = 0.01). Acute kidney injury requiring HD after implantation was not associated with significantly higher rates of readmissions compared with LVAD recipients without AKI on HD, after adjustment for clinical and hospital characteristics (41.4% vs. 30.5%; odds ratio 1.28; 95% confidence interval [CI]: 0.85-1.95; P = 0.239). However, 5.42% of these patients required maintenance hemodialysis in readmissions. In-hospital mortality and length of stay are decreasing but remain unacceptably high in patients requiring HD for AKI after LVAD implantation but remain higher than LVAD recipients without AKI on HD. A minority of these patients who survive hospital discharge require maintenance hemodialysis.