Novel Nebulized Milrinone Formulation for the Treatment of Acute Heart Failure Requiring Inotropic Therapy: A Phase 1 Study.

BACKGROUND: Nonintravenous inotropic-delivery options are needed for patients with inotropic-dependent heart failure (HF) to reduce the costs, infections and thrombotic risks associated with chronic central venous catheters and home infusion services. METHODS: We developed a novel, concentrated formulation of nebulized milrinone for inhalation and evaluated the feasibility, safety and pharmacokinetic profile in a prospective, single-arm, phase I clinical trial. We enrolled 10 patients with stage D HF requiring inotropic therapy during a hospital admission for acute HF. Milrinone 60 mg/4 mL was inhaled via nebulization 3 times daily for 48 hours. The coprimary outcomes were adverse events and pharmacokinetic profiles of inhaled milrinone. Acute changes in hemodynamic parameters were secondary outcomes. RESULTS: A concentrated nebulized milrinone formulation was well tolerated, without hypotensive events, arrhythmias or inhalation-related adverse events requiring discontinuation. Nebulized milrinone produced serum concentrations in the goal therapeutic range with a median plasma milrinone trough concentration of 39 (17-66) ng/mL and a median peak concentration of 207 (134-293) ng/mL. There were no serious adverse events. From baseline to 24 hours, mean pulmonary artery saturation increased (60% ± 7%-65 ± 5%; P = 0.001), and mean cardiac index increased (2.0 ± 0.5 mL/min/1.73m2-2.5 ± 0.1 mL/min/1.73m2; P = 0.001) with nebulized milrinone. CONCLUSIONS: In a proof-of-concept study, a concentrated, nebulized milrinone formulation for inhalation was safe and produced therapeutic serum milrinone concentrations. Nebulized milrinone was associated with improved hemodynamic parameters of cardiac output in a population with advanced HF. These promising results require further investigation in a longer-term trial in patients with inotrope-dependent advanced HF.

Electromagnetic interference from left ventricular assist devices detected in patients with implantable cardioverter-defibrillators.

INTRODUCTION: Electromagnetic interference (EMI) from left ventricular assist devices (LVADs) can cause implantable cardioverter-defibrillator (ICD) oversensing. We sought to assess the frequency of inappropriate shocks/oversensing due to LVAD-related EMI and prospectively compare integrated (IB) versus dedicated bipolar (DB) sensing in patients with LVADs. METHODS: Single-center study in LVAD patients with Medtronic or Abbott ICDs between September 2017 and March 2020. We excluded patients that were pacemaker dependent. Measurements were obtained of IB and DB sensing and noise to calculate a signal-to-noise ratio (SNR). Device checks were reviewed to assess appropriate and inappropriate sensing events. RESULTS: Forty patients (age 52 ± 14 years, 75% men, 38% ischemic cardiomyopathy) were included with the median time between LVAD implantation and enrollment of 6.7 months (2.3, 11.4 months). LVAD subtypes included: HeartWare (n = 22, 55%), Heartmate II (n = 10, 25%), and Heartmate III (n = 8, 20%). Over a follow-up duration of 21.6 ± 12.9 months after LVAD implantation, 5% of patients (n = 2) had oversensing of EMI from the LVAD (both with HeartWare LVADs and Abbott ICDs) at 4 days and 10.8 months after LVAD implantation. Both patients underwent adjustment of ventricular sensing with resolution of oversensing and no further events over 5 and 15 months of further follow-up. The SNR was similar between IB and DB sensing (50 [29-67] and 57 [41-69], p = 0.89). CONCLUSION: ICD oversensing of EMI from LVADs is infrequent and can be managed with reprogramming the sensitivity. There was no significant difference in the R-wave SNR with IB versus DB ICD leads.

Impact of ultra-conservative ICD programming in patients with LVADs: Avoiding potentially unnecessary tachy-therapies.

BACKGROUND: Patients with left ventricular assist devices (LVAD) often tolerate ventricular arrhythmias (VA). We aim to assess the frequency and outcomes of ICD therapies averted by ultraconservative ICD programming (UCP) in LVAD patients. METHODS: This single center, retrospective cohort study included patients with LVADs and ICDs implanted from 2015 to 2019 that had UCP. The aim for UCP was to maximally delay VA treatments and maximize anti-tachycardia pacing (ATP) prior to ICD shocks. VA events were reviewed after UCP and evaluated under prior conservative programming to assess for potentially averted events (that would have resulted in either ATP or defibrillation with prior programming). RESULTS: Fifty patients were included in the study with follow-up of median 16 ± 10.2 months after UCP. The median time from LVAD implantation to reprogramming was 7 days (IQR 5-9 days). Fourteen patients (28%) had potentially averted VA events that would have been treated with their prior ICD programming (82 total events, median two events per patient, IQR 1-10 events). Treated VA events occurred in 15 patients (30%). Eleven of the 14 patients with potentially averted VAs had treated events as well. Only one patient reported definitive symptoms of self-limited "dizziness" during a potentially averted event that did not result in hospitalization. No patients died of complications from or needed emergent care/hospitalization due a potentially averted VA. CONCLUSIONS: UCP in LVAD patients likely prevented unnecessary VA treatments in many patients with minimal reported symptoms during these potentially averted events. Prospective studies are necessary to confirm these findings.

Non-Invasive Cardiac Output Monitoring in Cardiogenic Shock: The NICOM Study.

BACKGROUND: The bioreactance technique is a relatively new, totally noninvasive technique that is used to measure cardiac output (CO) and is easy to use. The Non-Invasive Cardiac Output Monitor (NICOM) is 1 such system. Although approved by the Food and Drug Administration for measurement of stroke volume, there is a paucity of literature validating this technology in decompensated heart failure and cardiogenic shock. METHODS AND RESULTS: Fifty patients admitted to our cardiac intensive care unit for cardiogenic shock and Swan-Ganz catheter-guided therapy were prospectively enrolled in the study after informed consent. Simultaneous measurements of CO were obtained using NICOM, indirect Fick and bolus thermodilution. The intraclass correlation coefficient (ICC) was used to assess the precision of NICOM for CO using the 3 repeated measurements of CO over the pooled data. The agreement of the NICOM device in the defined clinical population, compared to indirect Fick and thermodilution, was evaluated by comparing the Pearson correlation coefficient, the Bland-Altman plot and the Lin concordance correlation coefficient. The ICC for cardiac output measured by NICOM showed excellent repeatability (ICC = 0.93, 95% CI = 0.92-0.94, n = 262) in the pooled data. The Pearson correlation coefficient for cardiac output measured by NICOM was poor when compared to indirect Fick (n = 263, r = 0.132, P = 0.033) and TD (n = 258, r = 0.275, P < 0.001). CONCLUSIONS: NICOM technology is not a reliable method of measuring CO in patients with decompensated heart failure and cardiogenic shock.

A novel, highly discriminatory risk model predicting acute severe right ventricular failure in patients undergoing continuous-flow left ventricular assist device implant.

Various risk models with differing discriminatory power and predictive accuracy have been used to predict right ventricular failure (RVF) after left ventricular assist device (LVAD) placement. There remains an unmet need for a contemporary risk score for continuous flow (CF)-LVADs. We sought to independently validate and compare existing risk models in a large cohort of patients and develop a simple, yet highly predictive risk score for acute, severe RVF. Data from the Mechanical Circulatory Support Research Network (MCSRN) registry, consisting of patients who underwent CF-LVAD implantation, were randomly divided into equal-sized derivation and validation samples. RVF scores were calculated for the entire sample, and the need for a right ventricular assist device (RVAD) was the primary endpoint. Candidate predictors from the derivation sample were subjected to backward stepwise logistic regression until the model with lowest Akaike information criterion value was identified. A risk score was developed based on the identified variables and their respective regression coefficients. Between May 2004 and September 2014, 734 patients underwent implantation of CF-LVADs [HeartMate II LVAD, 76% (n = 560), HeartWare HVAD, 24% (n = 174)]. A RVAD was required in 4.5% (n = 33) of the patients [Derivation cohort, n = 15 (4.3%); Validation cohort, n = 18 (5.2%); P = 0.68)]. 19.5% of the patients (n = 143) were female, median age at implant was 59 years (IQR, 49.4-65.3), and median INTERMACS profile was 3 (IQR, 2-3). RVAD was required in 4.5% (n = 33) of the patients. Correlates of acute, severe RVF in the final model included heart rate, albumin, BUN, WBC, cardiac index, and TR severity. Areas under the curves (AUC) for most commonly used risk predictors ranged from 0.61 to 0.78. The AUC for the new model was 0.89 in the derivation and 0.92 in the validation cohort. Proposed risk model provides very high discriminatory power predicting acute severe right ventricular failure and can be reliably applied to patients undergoing placement of contemporary continuous flow left ventricular assist devices.

Impact of a Monoplane Hemodynamic TEE (hTEE) Monitoring Device on Decision Making in a Heterogeneous Hemodynamically Unstable Intensive Care Unit Population: A Prospective, Observational Study.

OBJECTIVE: This prospective observational study was undertaken to evaluate the utility of a miniature transesophageal echocardiography probe (ImaCor hemodynamic [hTEE]) in the management of hemodynamically unstable intensive care unit patients with and without various forms of mechanical circulatory support. DESIGN: A prospective observational study. SETTING: A single tertiary care cardiothoracic and surgical intensive care unit. PARTICIPANTS: Fifty-three cardiothoracic and surgical intensive care unit patients undergoing miniature transesophageal echocardiography examinations. All patients had hemodynamic instability as defined by necessity of mechanical circulatory support (MCS) devices or vasoactive medications. INTERVENTIONS: From April 2012 to February 2014, 53 hemodynamically unstable intensive care unit patients received an examination with the miniature transesophageal echocardiography probe when deemed necessary by the intensivist for rapid and/or ongoing transesophageal echocardiographic examinations. Twenty-eight of the examinations were performed in patients with MCS devices (53%). The remainder of examinations (n = 25, 47%) were performed in patients after other cardiothoracic surgery or noncardiac surgery with cardiac complications. MEASUREMENTS AND MAIN RESULTS: The measured endpoint was determination of usefulness of management guidance due to the miniature transesophageal echocardiographic examination as assessed by the intensivist caring for the patient. The incidence of hTEE imaging provoking a change in management also was recorded. Overall, of the 53 examinations, 77% (n = 41) provided useful information to the management. Of the 25 examinations in patients without MCS, 92% (n = 23) of the examinations were useful in guiding management. Among the 28 examinations in patients with MCS devices, 64% (n = 18) of examinations were useful in guiding management (odds ratio = 0.156; 95% confidence interval, 0.015-0.899; p = 0.022). Eight of the 53 examinations (15%) were deemed to have "poor image quality" by the echocardiographer. Age, sex, and body mass index did not significantly affect the usefulness of the hTEE examinations. CONCLUSION: Examination of a heterogeneous hemodynamically unstable intensive care population with a miniature transesophageal echocardiography probe provided useful information beyond standard intensive care unit monitoring data, which influenced post-hTEE medical decision making. The examinations were more useful in patients without MCS devices than in those with MCS. Of the patients with MCS, patients with durable ventricular assist devices had the lowest rate of useful examinations.

Temporal Differences in Outcomes During Long-Term Mechanical Circulatory Support.

BACKGROUND: Device indications have changed for placement of continuous-flow left ventricular assist devices (CF-LVADs). We performed a multicenter analysis evaluating temporal variations in outcomes after CF-LVAD implantation. METHODS & RESULTS: We retrospectively defined 3 time intervals to reflect changes in CF-LVAD technology (period 1, 2004-2009; period 2, 2010-2012; and period 3, 2012-2014). A total of 1,064 patients (Heartmate II [HMII] = 835; Heartware [HVAD] = 229) underwent CF-LVAD implantation from May 2004 to October 2014. Device utilization was different between periods: period 1: HMII = 134 (100%); period 2: HMII = 480 (88%) and HW = 63 (12%); and period 3: HMII = 221 (57%) and HW = 166 (43%); P < .001. Despite few baseline group differences, adjusted survivals were similar among the time periods (P = .96). Adjusted multivariable analysis revealed age (per 10-year increase) and Interagency Registry for Mechanically Assisted Circulatory Support category (1 vs all others) as the only independent predictors of mortality: P < .001 and P = .008, respectively. Furthermore, it also showed the later periods to be at an increased risk of adverse events: 1) pump thrombosis (periods 2 and 3); and 2) gastrointestinal bleeding (period 3). CONCLUSIONS: Despite significant differences in device types, indications, and patient characteristics, post-implantation survivals were similar across time intervals. The most recent cohort seems to be at an increased risk of gastrointestinal bleeding and pump thrombosis.

Ventricular Assist Device Therapy in Older Patients With Heart Failure: Characteristics and Outcomes.

BACKGROUND: Limited data exist on outcomes in patients ≥70 years of age supported with the use of continuous-flow left ventricular assist devices (LVADs). METHODS: Data on 1149 continuous-flow LVAD recipients was queried from the Mechanical Circulatory Support Research Network. Groups were assigned based on age: ≥70 years ("older patients") and <70 years. The primary outcome was survival at one-year based on age grouping. RESULTS: Compared with younger patients (54.3 ± 11.2 y; n = 986), older patients (73.4 ± 3.0 y) constituted only 14% of LVAD implants. Older patients had similar rates of device thrombosis (P = .47) and stroke (P = .44), but survival-free of gastrointestinal bleeding (GIB) at 1 year was lower compared with younger patients (58% vs 69%; P < .01). Unadjusted survival at 1 year in older patients was 75% compared with 84% in younger patients, and at 2 years 65% versus 73% (P = .18). Age ≥70 years was not associated with increased mortality (adjusted hazard ratio [aHR] 0.94, 95% confidence interval [CI] 0.70-1.26; P = .67). Preoperative creatinine (aHR 1.57, 95% CI: 1.30-1.89, P < .0001), bilirubin (aHR 1.22, 95% CI 1.05-1.42; P = .010), and ischemic cardiomyopathy (aHR 1.43, 95% CI 1.11-1.84; P = .005) portended increased risk of death. In older patients, the only predictor of mortality was creatinine (HR 2.1, 95% CI 1.2-3.4; P = .007). Creatinine ≥1.4 mg/dL was associated with a 1-year survival of 65%, compared with 84% when the creatinine was <1.4 mg/dL (P = .009). CONCLUSION: Age >70 years is an important consideration when assessing LVAD risk, but other correlates may be more predictive of LVAD survival. Older patients without renal dysfunction have survival similar to younger patients. Older patients should be counseled about age-correlated risks, including higher rates of GIB.

Inhaled Milrinone After Left Ventricular Assist Device Implantation.

BACKGROUND: Proven strategies to reduce right ventricular (RV) dysfunction after continuous-flow left ventricular assist device (CF-LVAD) implantation are lacking. We sought to evaluate the tolerability, feasibility, efficacy, and pharmacokinetics of inhaled milrinone (iMil) delivery after CF-LVAD implantation. METHODS AND RESULTS: We prospectively evaluated fixed-dose nebulized iMil delivered into a ventilator circuit for 24 hours in 10 postoperative CF-LVAD (Heartmate-II) patients. Tolerability (arrhythmias, hypotension, and hypersensitivity reaction), efficacy (hemodynamics), pharmacokinetics (plasma milrinone levels), and cost data were collected.Mean age was 56 ± 9 years, 90% were male, and mean INTERMACS profile was 2.5 ± 0.8. No new atrial arrhythmia events occurred, although 3 (30%) ventricular tachycardia (1 nonsustained, 2 sustained) events occurred. Sustained hypotension, drug hypersensitivity, death, or need for right ventricular assist device were not observed. Invasive mean pulmonary arterial pressure from baseline to during iMil therapy was improved (P = .017). Mean plasma milrinone levels (ng/mL) at baseline, and 1, 4, 8, 12, and 24 hours were 74.2 ± 35.4, 111.3 ± 70.9, 135.9 ± 41.5, 205.0 ± 86.7, 176.8 ± 61.3 187.6 ± 105.5, respectively. Reduced institutional cost was observed when iMil was compared with nitric oxide therapy over 24 hours ($165.29 vs $1,944.00, respectively). CONCLUSIONS: iMil delivery after CF-LVAD implantation was well tolerated, feasible, and demonstrated favorable hemodynamic, pharmacokinetic, and cost profiles. iMil therapy warrants further study in larger clinical trials.

Minimally invasive thoracic left ventricular assist device implantation; case series demonstrating an integrated multidisciplinary strategy.

OBJECTIVES: The present report describes the authors' initial experience with implantation of the Heartware left ventricular assist devices (HeartWare Inc., Framingham, MA). via a minimally invasive surgical approach without cardiopulmonary bypass. A detailed overview of the anesthesiologist's role during the procedure, characteristics of the patient population, and short-term clinical outcomes are provided, and the clinical considerations that influence the decision to implant this device via an off-pump minimally invasive approach are outlined. DESIGN: Retrospective medical record review. SETTING: University hospital. PARTICIPANTS: Thirteen patients with advanced heart failure deemed candidates for off-pump minimally invasive left ventricular Heartware implantation as a bridge to heart transplantation. INTERVENTIONS: The Heartware left ventricular assist device was implanted in all 13 patients via a minimally invasive approach. MEASUREMENTS AND MAIN RESULTS: One patient required unplanned cardiopulmonary bypass to control bleeding around the left ventricular outflow cannula. The average operating room time was 249.8 minutes±46.2 minutes. Six of 13 patients required no intraoperative red blood cell transfusions. Seven patients were extubated within 12 hours after surgery. Two patients required reintubation within 48 hours. No patients required reoperation for bleeding. Average intensive care unit and hospital lengths of stay were 7.2±3.9 days and 13.4±3.6 days, respectively. There were no in-hospital deaths. CONCLUSIONS: Minimally invasive off-pump left ventricular Heartware implantation is an emerging alternative to placement by midline sternotomy. The authors speculate, based on their limited experience, that an off-pump thoracic strategy may be a desirable option for some patients and that clinical outcomes may be non-inferior to placement by midline sternotomy with cardiopulmonary bypass.

Combined usage of stem cells in end-stage heart failure therapies.

Remarkable achievements have been made in the clinical application of mechanical circulatory support and cardiac transplantation for patients with end-stage heart failure. Despite the successes, complications associated with these therapies continue to drive cardiac regenerative research utilizing stem cell based therapies. Multiple stem cell lineages hold clinical promise for cardiac regeneration-mostly through cellular differentiation, cellular fusion, and paracrine signaling mechanisms. Bone marrow-derived endothelial progenitor cells are among the most intriguing and controversial cell types currently being investigated. Formidable barriers exist, however, in finding the ideal cardiac regenerative stem cell, such as identifying specific lineage markers, optimizing in vitro cellular expansion and improving methods of stem cell delivery. Hybrid approaches of cardiac regeneration using stem cell therapies in conjunction with immunomodulation after cardiac transplantation or with mechanical circulatory support produce cutting edge stem cell technologies. This review summarizes the current knowledge and therapeutic applications of stem cells in patients with end-stage heart failure, including stem cell therapy after implantation of mechanical circulatory support and cardiac transplantation.

Worsening renal function in patients with acute decompensated heart failure treated with ultrafiltration: predictors and outcomes.

BACKGROUND: Ultrafiltration (UF) is used to treat patients with diuretic-resistant acute decompensated heart failure. The aim of this study was to identify predictors and the effect of worsening renal failure(WRF) on mortality in patients treated with UF. METHODS AND RESULTS: Based on changes in serum creatinine, 99 patients treated with UF were divided into WRF and control groups. Overall creatinine increased from 1.9 ± 0.7 to 1.2 ± 1.0 mg/dL (P!.001),and WRF developed in 41% of the subjects. The peak UF rate was higher in the WRF group in univariate analysis (174 ± 75 vs 144 ± 52 mL/h; P = .03). Based on multivariate analysis, aldosterone antagonist treatment (odds ratio [OR] 3.38, 95% confidence interval [CI] 1.17-13.46, P = .04), heart rate ≤65 beats/min (OR 6.03, 95% CI 1.48-48.42; P = .03), and E/E0 ≥ 15 (OR 3.78, 95% CI 1.26-17.55; P 5 .04) at hospital admission were associated with WRF. Patients with baseline glomerular filtration rate (GFR) ≤60mg/dL who developed WRF during UF had a 75% 1-year mortality rate. CONCLUSIONS: WRF occurred frequently during UF. Increased LV filling pressures, lower heart rate, and treatment with aldosterone antagonist at hospital admission can identify patients at increased risk for WRF. Patients with baseline GFR ≤60 mg/dL and WRF during UF have an extremely high 1-year mortality rate.

Are peripherally inserted central catheters associated with increased risk of adverse events in status 1B patients awaiting transplantation on continuous intravenous milrinone?

BACKGROUND: Peripherally inserted central catheters (PICCs) are used to deliver continuous intravenous (IV) milrinone in stage D heart failure (HF) patients awaiting heart transplantation (HT). METHODS: We retrospectively analyzed PICC adverse events (AEs) and associated cost in 129 status 1B patients from 2005 to 2012. End points were HT, left ventricular assist device (LVAD), and death. Regression analysis was used to identify AE risk factors. RESULTS: Fifty-three PICC AEs occurred in 35 patients (27%), consisting of 48 infections, 4 thromboses, and 1 bleeding event. Median duration of PICC support was 63 (interquartile range [IQR] 34-131) days, and median time to first PICC infection was 44 (IQR 14-76) days. Among PICC infections, 9% required defibrillator removal and 30% were inactivated on the HT list for a mean of 23 ± 17 days. Rate of HT, LVAD, or death was similar between groups (P > .05). Regression analysis found that a double lumen PICC was associated with a shorter time to first PICC infection (hazard ratio 7.59, 95% CI 1.97-29.23; P = .003). Median cost per PICC infection was $10,704 (IQR $7,401-$26,083). CONCLUSIONS: PICC infections were the most frequent AEs. PICCs with >1 lumen were associated with increased risk of infection. PICC AEs accounted for increased intensive care unit admissions, HT list inactivations, and overall cost.

Hemodynamic transesophageal echocardiography after left ventricular assist device implantation.

OBJECTIVE: The authors hypothesized that the clinical profile of patients undergoing hTEE after continuous flow left ventricular assist device (CF-LVAD) implant would be in patients with greater acuity, more blood product utilization, and longer length of ICU stay, and that hTEE would change clinical management. DESIGN: Retrospective review. SETTING: University hospital. PARTICIPANTS: One hundred consecutive patients receiving a CF-LVAD. INTERVENTIONS: Retrospective review using a standardized electronic form of a miniaturized disposable transesophageal echocardiography probe that documented not only physical findings but also changes in hemodynamic management (hTEE) in CF-LVAD patients. MEASUREMENTS AND MAIN RESULTS: Of the 100 patients, 41 received an hTEE probe. The INTERMACS score, Leitz-Miller Score, and Kormos score indicated the hTEE group had a statistically significant greater risk of morbidity and mortality. Interoperatively, the hTEE group received more blood products and was more likely to have an open chest. Postoperatively, the hTEE group received more blood products, had a longer total length of stay, and had increased mortality. ICU length of stay, days on inotropes and days on mechanical ventilation were not statistically significant between the 2 groups. Information obtained from hTEE changed ICU management in 72% of studies. CONCLUSION: Retrospective review of CF-LVAD patients revealed that postoperative hTEE is used in sicker CF-LVAD patients and frequently leads to changes in ICU clinical management.

Worsening renal function in patients with acute decompensated heart failure treated with ultrafiltration: predictors and outcomes.

BACKGROUND: Ultrafiltration (UF) is used to treat patients with diuretic-resistant acute decompensated heart failure. The aim of this study was to identify predictors and the effect of worsening renal failure (WRF) on mortality in patients treated with UF. METHODS AND RESULTS: Based on changes in serum creatinine, 99 patients treated with UF were divided into WRF and control groups. Overall creatinine increased from 1.9 ± 9.7 to 2.2 ± 2.0 mg/dL (P < .001), and WRF developed in 41% of the subjects. The peak UF rate was higher in the WRF group in univariate analysis (174 ± 45 vs 144 ± 42 mL/h; P = .03). Based on multivariate analysis, aldosterone antagonist treatment (odds ratio [OR] 3.38, 95% confidence interval [CI] 1.17-13.46, P = .04), heart rate ≤65 beats/min (OR 6.03, 95% CI 1.48-48.42; P = .03), and E/E' ≥15 (OR 3.78, 95% CI 1.26-17.55; P = .04) at hospital admission were associated with WRF. Patients with baseline glomerular filtration rate (GFR) ≤60 mg/dL who developed WRF during UF had a 75% 1-year mortality rate. CONCLUSIONS: WRF occurred frequently during UF. Increased LV filling pressures, lower heart rate, and treatment with aldosterone antagonist at hospital admission can identify patients at increased risk for WRF. Patients with baseline GFR ≤60 mg/dL and WRF during UF have an extremely high 1-year mortality rate.

Impact of Biopsy Proven Liver Fibrosis on Patients Undergoing Evaluation and Treatment for Advanced Heart Failure Surgical Therapies.

There is a paucity of data regarding the impact of liver fibrosis on patients with stage D heart failure (HF). We conducted a retrospective study (January 1, 2017 to December 12, 2020) in patients with stage D HF who underwent liver biopsy as part of their advanced HF therapy evaluation. Baseline characteristics and 1-year outcomes were compared between no- or mild-to-moderate-fibrosis (grade 0 to 2) and advanced-fibrosis (grade 3 to 4) groups. Of 519 patients with stage D HF, 136 who underwent liver biopsy (113 [83%] no or mild-to-moderate fibrosis and 23 [17%] advanced fibrosis) were included. A total of 71 patients (52%) received advanced HF therapies (23 heart transplantation, 48 left ventricular assist devices). One-year mortality was higher among patients with advanced fibrosis (52% vs 18%, p <0.001). Further subgroup analysis suggested a trend toward increased 1-year mortality among patients with advanced fibrosis who underwent advanced therapies (37% vs 13%, p = 0.09). There was a trend of lower likelihood of receiving advanced HF therapies in the advanced-fibrosis group, only 1 heart transplantation and 7 left ventricular assist devices, but it did not reach statistical significance (35% vs 56%, p = 0.06). After adjustment for confounders, degree of liver fibrosis was an independent predictor of mortality (odds ratio 6.2; 95% 1.27 to 30.29, p = 0.02). We conclude that advanced liver fibrosis is common among patients with stage D HF who undergo evaluation for advanced HF surgical therapies and significantly increases 1-year mortality. Further larger studies are needed to support our findings.

Inpatient characteristics, complications, and outcomes of patients with cardiac sarcoidosis: A study from the National Inpatient Sample.

Although seen in ∼5% of sarcoidosis patients, cardiac sarcoidosis (CS) accounts for nearly 25% of disease-related deaths. This study aimed to describe characteristics and outcomes among CS patients. Patients diagnosed with CS in 2016-2017 in the US National Inpatient Sample Database were evaluated to study patient characteristics, reasons ascribed to admission, in-hospital outcomes, and complications. A total of 2420 patients (median age 56 years) were included in the analysis. Most admissions occurred due to ventricular tachycardia (12.8%), followed by myocarditis (9.9%) with a mean length of stay of 7 ± 7 days. The overall incidence of in-hospital mortality was 2.5%.

Use of Extracorporeal Membrane Oxygenation as Bridge to Replacement Therapies in Cardiogenic Shock: Insights From the Extracorporeal Life Support Organization.

BACKGROUND: There has been increasing use of extracorporeal membrane oxygenation (ECMO) as bridge to heart transplant (orthotopic heart transplant [OHT]) or left ventricular assist device (LVAD) over the last decade. We aimed to provide insights on the population, outcomes, and predictors for the selection of each therapy. METHODS: Using the Extracorporeal Life Support Organization Registry between 2010 and 2019, we compared in-hospital mortality and length of stay, predictors of OHT versus LVAD, and predictors of in-hospital mortality for patients with cardiogenic shock that were bridged with ECMO to OHT or LVAD. One hundred sixty-seven patients underwent LVAD versus 234 patients who underwent OHT. RESULTS: The overall use of ECMO has increased from 1.7% in 2010 to 22.2% in 2019. Mortality was similar between groups (LVAD: 28.7% versus OHT: 29.1%) while length of stay was longer for OHT (LVAD: 49.6 versus OHT: 59.5 days, P=0.05). Factors associated with OHT included prior transplant (odds ratio [OR]=31.26 [CI, 3.84-780.5]), use of a temporary pacemaker (OR=6.5 [CI, 1.39-50.15]), and increased use of inotropes on ECMO (OR=3.77 [CI, 1.39-11.07]), whereas LVAD use was associated with weight (OR=0.98 [CI, 0.97-0.99]), cardiogenic shock presentation (OR=0.40 [CI, 0.21-0.78]), previous LVAD (OR=0.01 [CI, 0.0001-0.22]), respiratory failure (OR=0.28 [CI, 0.11-0.70]), and milrinone infusion (OR=0.32 [CI, 0.15-0.67]). Older age (OR=1.07 [CI, 1.02-1.12]), cannulation bleeding (OR=26.1 [CI, 4.32-221.3]), and surgical bleeding (OR=6.7 [CI, 1.26-39.9]) in patients receiving LVAD and respiratory failure (OR=5 [CI, 1.17-23.1]) and continuous renal replacement therapy (OR=3.82 [CI, 1.28-11.9]) in patients receiving OHT were associated with increased mortality. CONCLUSIONS: ECMO use as a bridge to advanced therapies has increased over time, with more patients undergoing LVAD than OHT. Mortality was equal between the 2 groups while length of stay was longer for OHT.

Thirty-day readmissions among patients with cardiogenic shock who underwent extracorporeal membrane oxygenation support in the United States: Insights from the nationwide readmissions database.

Background: There is a paucity of data on readmission rates and predictors of readmissions in cardiogenic shock patients after contemporary Extracorporeal Membrane Oxygenation (ECMO) use. Methods: Using the Nationwide Readmission Database, we included adult patients (≥18 years old) hospitalized between January to November 2016-2018 for cardiogenic shock requiring ECMO support. Thirty-day readmission rates, associated variables, and predictors of readmission were assessed. Results: A total of 10,723 patients underwent ECMO for cardiogenic shock. After excluding patients who died (n = 5602; 52%) and who underwent LVAD or OHT during index admission (n = 892; 8%), 4229 patients discharged alive were included. Of those, 694 (16.4%) were readmitted within 30 days. The median time to readmission was 10 days. Diabetes mellitus (OR = 1.77; 95% CI 1.32-2.37), chronic liver disease (OR = 1.35; 95% CI 1.03-1.77), and prolonged LOS (≥30 days; OR = 1.38; 95% CI 1.05-1.81) were associated with increased risk of 30-day readmissions while heart failure diagnosis (OR = 0.69; 95% CI 0.50-0.95) and short-term hospital post-discharge care (OR = 0.53; 95% CI 0.28-0.99) conferred a lower risk. Sepsis, followed by congestive heart failure, was the most common readmission diagnoses. Conclusions: Patients with CS requiring ECMO support have high mortality and high 30-day readmission rates, with sepsis being the leading cause of readmissions followed by heart failure.