Trends and outcomes of device-related 30-day readmissions after left ventricular assist device implantation

BackgroundLeft ventricular assist devices (LVAD) improve morbidity and mortality in end-stage heart failure patients, but high rates of readmissions remain a problem after implantation. We aimed to assess the incidence, trends, outcomes, and predictors of device-related 30-day readmissions after LVAD implantation.MethodsThe National Readmission Database was used to identify patients who underwent LVAD implantation between 2012 and 2017 and those with 30-day readmissions.ResultsThe analysis included a total of 16499 adults who survived the index hospitalization for LVAD implantation. Among those, 28.1% were readmitted at 30 days, and the readmission rate has been grossly stable during the study period. Most of the readmissions occurred in the first 15 days after discharge from the index admission. The most frequent cause of readmissions was gastrointestinal bleeding (14.9% of readmissions), followed by heart failure, arrhythmias, device infection, and device thrombosis. Among reasons for readmission, intracranial bleeding was associated with highest mortality (37.6%), followed by device thrombosis (13.1%), and ischemic stroke (7.6%). Intracranial bleeding and device thrombosis were associated with lengthier stay (20.4 and 15.5 days, respectively). Readmission rates for gastrointestinal bleeding decreased, whereas device infection increased. Multivariate logistic regression model revealed the length of stay, oxygen dependence, gastrointestinal bleeding at index admission, depression and ECMO, private insurance as independent predictors of 30-day readmission.ConclusionOver one-fourth of LVAD recipients have 30-day readmissions, with most of them occurring within 15 days. Most frequent cause of readmission was gastrointestinal bleeding, which was associated with the lowest in-hospital mortality among other complications.     

Association Between Timing of Extracorporeal Membrane Oxygenation and Clinical Outcomes in Refractory Cardiogenic Shock

ObjectivesThe aim of this study was to investigate whether earlier extracorporeal membrane oxygenation (ECMO) support is associated with improved clinical outcomes in patients with refractory cardiogenic shock (CS).BackgroundThe prognosis of patients with refractory CS receiving ECMO remains poor. However, little is known about the association between the timing of ECMO implantation and clinical outcomes in these patients.MethodsFrom a multicenter registry, 362 patients with refractory CS who underwent ECMO between January 2014 and December 2018 were identified. Participants were classified into 3 groups according to tertiles of shock-to-ECMO time (early, intermediate, and late ECMO). Inverse probability of treatment weighting was conducted to adjust for baseline differences among the groups, followed by a weighted Cox proportional hazards regression analysis to calculate hazard ratios and 95% confidence intervals for 30-day mortality associated with each ECMO time group.ResultsThe overall 30-day mortality rate was 40.9%. The risk for 30-day mortality was lower in the early group than in the late group (hazard ratio: 0.53; 95% confidence interval: 0.28 to 0.99). Early ECMO support was also associated with lower risk for in-hospital mortality, ECMO weaning failure, composite of all-cause mortality or rehospitalization for heart failure at 1 year, all-cause mortality at 1 year, and poor neurological outcome at discharge. However, the incidence of adverse events, including stroke, limb ischemia, ECMO-site bleeding, and gastrointestinal bleeding, did not differ significantly among the groups.ConclusionsEarlier ECMO support was associated with improved clinical outcomes in patients with refractory CS.     

Sixteen-Year National Trends in Use and Outcomes of VA-ECMO in Cardiogenic Shock

There is a lack of data on contemporary trends in the use and outcomes of Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO) for cardiogenic shock (CS) at a national level. Patients with CS admitted during January 1st, 2002-December 31, 2018, were identified from the United States National Inpatient Sample. Among all patients admitted with CS, those who received VA-ECMO were identified. We report the trends in use and outcomes in terms of mortality, exit strategies and complications among all patients who received VA ECMO for CS. Among a total of approximately 1.6 million patients admitted with CS during the period from January 1st, 2002 to December 31, 2018; 25, 621(1.5 %) received VA-ECMO. There has been a 23-fold increase in the use of VA-ECMO over the study period, from 0.1 % in 2002 to 3 % in 2018, with a simultaneous decreasing trend of in hospital mortality from 77 % in 2002 to 50 % in 2018. Only approximately 15 % of VA-ECMO patients are discharged home with most survivors discharged to a skilled nursing facility or short-term rehabilitation. Moreover, only a minor proportion of patients on VA ECMO are bridged to heart replacement therapy with durable LVAD (6 %) or cardiac transplantation (2.5 %). In conclusion, the use of VA-ECMO in CS has increased 23-fold from January 2002 to December 2018 with a concomitant decrease in mortality from 77 % in 2002 to 50 % in 2018, only a minority of patients on VA-ECMO for CS are bridged to durable LVAD or cardiac transplantation.     

Contemporary Use of Venoarterial Extracorporeal Membrane Oxygenation: Insights from the Multicenter RESCUE Registry

BackgroundVenoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly used as a life-saving therapy for patients with cardiovascular collapse, but identifying patients unlikely to benefit remains a challenge.Methods and ResultsWe created the RESCUE registry, a retrospective, observational registry of adult patients treated with VA-ECMO between January 2007 and June 2017 at 3 high-volume centers (Columbia University, Duke University, and Washington University) to describe short-term patient outcomes. In 723 patients treated with VA-ECMO, the most common indications for deployment were postcardiotomy shock (31%), cardiomyopathy (including acute heart failure) (26%), and myocardial infarction (17%). Patients frequently suffered in-hospital complications, including acute renal dysfunction (45%), major bleeding (41%), and infection (33%). Only 40% of patients (n = 290) survived to discharge, with a minority receiving durable cardiac support (left ventricular assist device [n = 48] or heart transplantation [n = 7]). Multivariable regression analysis identified risk factors for mortality on ECMO as older age (odds ratio [OR], 1.26; 95% confidence interval [CI], 1.12–1.42) and female sex (OR, 1.44; 95% CI, 1.02–2.02) and risk factors for mortality after decannulation as higher body mass index (OR 1.17; 95% CI, 1.01-1.35) and major bleeding while on ECMO support (OR, 1.92; 95% CI, 1.23–2.99).ConclusionsDespite contemporary care at high-volume centers, patients treated with VA-ECMO continue to have significant in-hospital morbidity and mortality. The optimization of outcomes will require refinements in patient selection and improvement of care delivery.     

Interdependence of VA-ECMO output,pulmonary congestion and outcome after cardiac surgery

BackgroundVenoarterial-extracorporeal membrane oxygenation (VA-ECMO) is a life-saving method for patients with low-output failure after cardiac surgery. However, VA-ECMO therapy may increase left ventricular afterload due to retrograde blood flow in the aorta, which may lead to progression of pulmonary congestion. We examined the predictive value of pulmonary congestion in patients that need VA-ECMO support after cardiovascular surgery.MethodsWe enrolled a total of 266 adult patients undergoing VA-ECMO support following cardiovascular surgery at a university-affiliated tertiary care centre into our single-center registry. Pulmonary edema was assessed on bedside chest X rays at day 0, 3, 5 after VA-ECMO implantation.ResultsMedian age was 65 (57–72) years, 69% of patients were male and 30-day survival was 63%. At ICU-admission 20% of patients had mild, 54% had moderate and 26% showed severe pulmonary congestion. Pulmonary congestion at day 0 was not associated with outcome (adjusted HR 1.31; 95%-CI 0.89–1.93;P = 0.18), whereas pulmonary congestion at day 3 (adj. HR 2.81; 95%-CI 1.76–4.46;P<0.001) and day 5 (adj. HR 3.01;95%-CI 1.84–4.93;P<0.001) was significantly associated with survival. Linear regression revealed that out of left ventricular function, cardiac output, central venous saturation, maximum dobutamine and norepinephrine dose as well as fluid balance solely ECMO rotation was associated with the evolution of pulmonary congestion (P = 0.007).ConclusionsPulmonary edema three and five days after ECMO implantation are associated with poor survival. Interestingly, a high VA-ECMO output was the most important determinant of worsening pulmonary congestion within the first five days.     

Contemporary Trends of Clinical Outcomes in Primary Left Ventricular Assist Device Implantation and Postprocedure High-Risk Categories

ObjectiveWe aimed to analyze trends of 30-day readmission and find high-risk patients associated with increased risk of mortality, resource use, and readmission after primary left ventricular assist device (LVAD) implantation. Limited data exist on the contemporary trends of readmission rates and patients at a higher risk of worse outcomes after LVAD implantation.Methods and ResultsThis is a retrospective study of adults from the Nationwide Readmission Database who underwent primary durable LVAD implantation from 2010 to 2018. The main outcomes were 30-day readmission rates and their trends in patients with primary durable LVAD implantation from 2010 to 2018. This study also sought to identify patients at the highest risk for readmission, in-hospital mortality, and resource use. A total of 31,002 adults with primary durable LVAD implantation were included in the present analysis. Overall, 3808 patients (12.3%) died and 27,168 (87.6%) were discharged alive. Of those discharged alive, 8303 patients (30.6%) were readmitted within 30 days. The trend of 30-day all-cause readmission among LVAD implantation patients remained similar from 2010 to 2018 (P = .809). The in-hospital mortality rate during the index hospitalization decreased significantly (P = .014), and the mean cost of an index hospitalization increased (P = .031) during the study period. The patients with post-LVAD in-hospital cardiac, vascular, and thromboembolic complications (ie, high-risk patients) had the highest mortality, resource use, and readmission rates compared with patients without major complications.ConclusionsThis study found that the readmission rates associated with LVAD implantation did not change from 2010 to 2018 and identified high-risk patients who may benefit from closer monitoring after primary LVAD implantation.     

Extracorporeal Membrane Oxygenation for Graft Dysfunction Early After Heart Transplantation: A Systematic Review and Meta-analysis

IntroductionVenoarterial extracorporeal membrane oxygenation (VA-ECMO) is a prevailing option for the management of severe early graft dysfunction. This systematic review and individual patient data (IPD) meta-analysis aims to evaluate (1) mortality, (2) rates of major complications, (3) prognostic factors, and (4) the effect of different VA-ECMO strategies on outcomes in adult heart transplant (HT) recipients supported with VA-ECMO.Methods and ResultsWe conducted a systematic search and included studies of adults (≥18 years) who received VA-ECMO during their index hospitalization after HT and reported on mortality at any timepoint. We pooled data using random effects models. To identify prognostic factors, we analysed IPD using mixed effects logistic regression. We assessed the certainty in the evidence using the GRADE framework. We included 49 observational studies of 1477 patients who received VA-ECMO after HT, of which 15 studies provided IPD for 448 patients. There were no differences in mortality estimates between IPD and non-IPD studies. The short-term (30-day/in-hospital) mortality estimate was 33% (moderate certainty, 95% confidence interval [CI] 28%–39%) and 1-year mortality estimate 50% (moderate certainty, 95% CI 43%–57%). Recipient age (odds ratio 1.02, 95% CI 1.01–1.04) and prior sternotomy (OR 1.57, 95% CI 0.99–2.49) are associated with increased short-term mortality. There is low certainty evidence that early intraoperative cannulation and peripheral cannulation reduce the risk of short-term death.ConclusionsOne-third of patients who receive VA-ECMO for early graft dysfunction do not survive 30 days or to hospital discharge, and one-half do not survive to 1 year after HT. Improving outcomes will require ongoing research focused on optimizing VA-ECMO strategies and care in the first year after HT.     

Efficacy of Mechanical Circulatory Support Used Before Versus After Primary Percutaneous Coronary Intervention in Patients with Cardiogenic Shock From ST-Elevation Myocardial Infarction: A Systematic Review and Meta-Analysis

BackgroundOptimal timing to initiate mechanical circulatory support (MCS) in patients with ST-elevation myocardial infarction (STEMI) complicated by cardiogenic shock (CS) remains unclear with studies showing conflicting results on whether to start before or after primary percutaneous coronary intervention (PPCI). This study aims to examine the association between mortality and MCS initiated before vs after PPCI in patients with STEMI complicated by CS.MethodsWe systematically searched PubMed, Embase, and Scopus for abstracts and full-text articles from inception to October 2021. Studies were included if they evaluated the association of mortality in patients who initiated MCS (specifically intra-aortic balloon pump (IABP), Impella, and venoarterial extracorporeal membrane oxygenation (VA-ECMO)) before PPCI versus after PPCI, specifically in patients with STEMI complicated by CS. Data were integrated using the random-effects models.ResultsTen studies involving 1,352 patients (956, 203, and 193 patients underwent IABP, Impella, and VA-ECMO respectively) with STEMI complicated by CS were included. There was no difference in mortality using IABP before or after PPCI ([OR] 1.77, 95% CI 0.77–1.61, I2 = 27%, p = 0.57). Nevertheless, Impella and VA-ECMO started before PPCI were significantly associated with a reduced risk of mortality compared to that started after PPCI ([OR] 0.49, 95% CI 0.26–0.92, I2 = 0%, p = 0.03 and [OR] 0.29, 95% CI 0.14–0.62, I2 = 0%, p = 0.001, respectively).ConclusionsIn patients with STEMI complicated by CS undergoing PPCI, the use of IMPELLA or VA-ECMO prior to PPCI significantly decreased mortality, in contrast to IABP, in which no difference in mortality was found between using it before or after PPCI. More rigorous studies are needed to clarify this association.     

Use of durable left ventricular assist devices for high-risk patients: Korean experience before insurance coverage

BackgroundLeft ventricular assist devices (LVADs) were not covered by the Korean national insurance until September 2018, and they were implanted at the patient’s own or a third party’s expense. However, there have been no reports on using an LVAD without insurance coverage or manufacturer support.MethodsWe reviewed 23 patients who underwent durable LVAD implantation at our institution from August 2012 to September 2018. Patients with temporary LVADs using extracorporeal or paracorporeal circulation were excluded. The available devices were the HeartMate II^TM (HMII) and HeartWare^TM Ventricular Assist Device (HVAD). The primary outcome was 30-day mortality. The secondary outcomes were postoperative complications and late mortality.ResultsThe mean age of the patients was 68.7±9.9 years. The study sample comprised six female (26.1%) and 17 male (73.9%) patients. All patients had modifiable (bridge to candidacy) or unmodifiable absolute (destination therapy) contraindications for heart transplantation (HT). Among the patients in this study, 12 (52.2%) had ischemic cardiomyopathy and 11 (47.8%) had non-ischemic cardiomyopathy. Nine patients (39.1%) had temporary mechanical circulatory support such as extracorporeal membrane oxygenation or a temporary LVAD in place preoperatively. The average duration of LVAD support was 618.6±563.2 days (range, 59–2,285 days). There was no 30-day mortality. Four patients (17.4%) underwent HT. Six patients (26.1%) underwent re-exploration for postoperative bleeding, and one patient (4.3%) had a disabling stroke after discharge. The estimated survival rates at 12 and 24 months were 89.2% and 68.8%, respectively.ConclusionsAll patients who received LVADs before insurance coverage had contraindications for HT. The overall outcomes were comparable with those reported in the international registry.     

Outcomes in Patients With Chronic Kidney Disease and End-stage Renal Disease and Durable Left Ventricular Assist Device: Insights From the United States Renal Data System Database

BackgroundThere is paucity of data regarding durable left ventricular assist device (LVAD) outcomes in patients with chronic kidney disease (CKD) stages 3–5 and CKD stage 5 on dialysis (end-stage renal disease [ESRD]).Methods and ResultsWe conducted a retrospective study of Medicare beneficiaries with ESRD and a 5% sample of patients with CKD with an LVAD (2006–2018) to determine 1-year outcomes using the United States Renal Data System database. The LVAD implantation, comorbidities, and outcomes were identified using appropriate International Classification of Diseases, 9th and 10th edition codes. We identified 496 patients with CKD and 95 patients with ESRD who underwent LVAD implantation. The patients with ESRD were younger (59 years vs 66 years; P < .001), had more Blacks (40% vs 24.6%, P = .009), compared with the CKD group. The 1-year mortality (49.5% vs 30.9%, P < .001) and index mortality (27.4% vs 16.7%, P = .014) rates were higher for patients with ESRD. A subgroup analysis showed significantly higher mortality in ESRD vs CKD 3 (49.5% vs 30.2%, adjusted P = .009), but no significant difference in mortality between stage 3 vs 4/5 (30.2% vs 30.8%, adjusted P = .941). There was no significant difference in secondary outcomes (bleeding, stroke, and sepsis/infection) during follow-up between the 2 groups.ConclusionsPatients with ESRD undergoing LVAD implantation had significantly higher index and 1-year mortality rates compared with patients with CKD.     

The Effect of Age on Outcomes After Destination-Therapy Left Ventricular Assist Device Implantation: An Analysis of the IMACS Registry

BackgroundAs patients with advanced heart failure are living longer, defining the impact of left ventricular assist devices (LVADs) on outcomes in an aging population is of great importance. We describe overall survival, rates of adverse events (AEs), and post-AE survival in patients age ≥ 70 years vs age 50-69 years after destination-therapy (DT) LVAD implantation.MethodsA retrospective analysis was conducted with the use of the International Society for Heart and Lung Transplantation Mechanically Assisted Circulatory Support (IMACS) registry. All adults age ≥ 50 years with a continuous-flow DT LVAD from 2013 to 2017 were included. The primary outcome was all-cause mortality. The secondary outcomes were the incidence of and survival after gastrointestinal (GI) bleeding, infection, stroke, pump thrombosis, pump exchange, and right-side heart failure. Mortality and AEs were assessed with the use of competing risk models.ResultsAt total of 5,572 patients were included: 3,700 aged 50-69 and 1,872 aged ≥ 70. All-cause mortality by 42 months was 55.8% in patients aged ≥ 70 and 44.8% in patients aged 50-69 (P = 0.001). Patients aged ≥ 70 had a 37.8% higher risk of death after DT LVAD implantation (hazard ratio 1.378, 95% CI 1.251-1.517). Patients aged ≥ 70 had higher risk of GI bleeding but lower risk of right-side heart failure. There was no difference between age groups for risk of infection or stroke. Experiencing any AE was associated with an increased risk of death that did not vary with age.ConclusionsPatients aged ≥ 70 years have reduced survival after DT LVAD, in part because of increased GI bleeding, while the incidence of other AEs is similar to that of patients aged 50-69 years. Careful patient selection beyond age alone may allow for optimal outcomes after DT LVAD implantation.     

Impella Versus Extracorporeal Membranous Oxygenation (ECMO) for Cardiogenic Shock: A Systematic Review and Meta-analysis

The use of mechanical circulatory support (MCS) in cardiogenic shock (CS) is increasing. We conducted a systematic review and meta-analysis to compare the outcomes of Impella use with extracorporeal membranous oxygenation (ECMO) support in patients with CS. We searched the Medline, EMBASE, Cochrane, and Clinicaltrials.gov databases for observational studies comparing Impella to ECMO in patients with CS. Risk ratios (RRs) for categorical variables and standardized mean differences (SMDs) for continuous variables were calculated with 95% confidence intervals (CIs) using a random-effects model. Twelve retrospective studies and one prospective study (Impella n=6652, ECMO n=1232) were identified. Impella use was associated with lower incidence of in-hospital mortality (RR 0.88 [95% CI 0.80-0.94], P=0.0004), stroke (RR 0.30 [0.21-0.42], P<0.00001), access-site bleeding (RR 0.50 [0.37-0.69], P<0.0001), major bleeding (RR 0.56 [0.39-0.80], P=0.002), and limb ischemia (RR 0.42 [0.27-0.65], P=0.0001). Baseline lactate levels were significantly lower in the Impella group (SMD -0.52 [-0.73- -0.31], P<0.00001). There was no significant difference in mortality at 6-12 months, MCS duration, need for MCS escalation, bridge-to-LVAD or heart transplant, and renal replacement therapy use between Impella and ECMO groups. In patients with CS, Impella device use was associated with lower in-hospital mortality, stroke, and device-related complications than ECMO. However, patients in the ECMO group had higher baseline lactate levels.     

Thirty-Day Readmissions After Chronic Total Occlusion Percutaneous Coronary Intervention in the United States: Insights From the Nationwide Readmissions Database

BackgroundSeveral studies have investigated early readmissions after percutaneous coronary interventions (PCIs). However, studies investigating 30-day readmission following PCI for chronic total occlusion (CTO) are lacking.MethodsThe National-Readmission-Database (NRD) was queried to identify patients undergoing elective CTO PCI between January 1, 2016 and December 31, 2016. We assessed the incidence, predictors, and cost of 30-day readmissions.ResultsA total of 30,579 CTO PCIs were identified in the NRD. After excluding patients who had acute myocardial infarction (n = 14,852), the final cohort included 15,907 patients. In this group of patients, 254 patients (1.5%) expired during their index admission and, 1600 patients (10%) had an unplanned readmission within 30 days. Cardiac causes constituted 54.2% of all causes of readmission. During the readmission, 15.8% of patients had coronary angiography, 8.4% underwent PCI, and 0.9% underwent bypass grafting. Independent predictors of 30-day readmission included baseline characteristics [age (OR 0.99, 95%CI 0.98–0.99), female (OR 1.14, 95%CI 1.01–1.28), lung disease (OR 1.36, 95%CI 1.20–1.55), heart failure (OR 1.42, 95%CI 1.24–1.62), anemia (OR 1.30, 95%CI 1.12–1.50), vascular disease (OR 1.18, 95%CI 1.03–1.35), history of stroke (OR 1.50, 95%CI 1.28–1.76) and the presence of a defibrillator (OR 1.68, 95%CI 1.39–2.03)], and procedural complications [acute kidney injury (OR 1.55, 95%CI 1.33–1.80) and gastrointestinal bleeding (OR 1.67, 95%CI 1.03–2.71)].ConclusionsOne-tenth of patients undergoing CTO PCI are readmitted within 30-days, mostly for cardiac causes. The majority undergo angiography but <10% receive revascularization. Certain patient and procedural characteristics independently predicted 30-day readmission.     

Modelo de predicción de riesgo de mortalidad hospitalaria para pacientes con infarto de miocardio tratados con oxigenador extracorpóreo de membrana venoarterial

Introduction and objectivesThere are limited data to develop a risk prediction model of in-hospital mortality for acute myocardial infarction (AMI) patients treated with venoarterial (VA)-extracorporeal membrane oxygenation (ECMO). We aimed to develop a risk prediction model for in-hospital mortality in patients with AMI who were treated with VA-ECMO.MethodsA total of 145 patients with AMI who underwent VA-ECMO between May 2004 and April 2016 were included from the Samsung Medical Center ECMO registry. The primary outcome was in-hospital mortality. To develop a new predictive scoring system, named the AMI-ECMO score, backward stepwise elimination and β coefficient-based scoring were used based on logistic regression analyses. The leave-one-out cross-validation method was performed for internal validation.ResultsIn-hospital mortality occurred in 69 patients (47.6%). On multivariable logistic regression analysis, the AMI-ECMO score comprised 6 pre-ECMO or angiographic parameters: age > 65 years, body mass index > 25 kg/m², Glasgow coma score < 6, lactic acid > 8 mmol/L, anterior wall infarction, and no or failed revascularization. The C-statistic value of AMI-ECMO score for predicting in-hospital mortality was 0.880 (95%CI, 0.820-0.940). The incidence of in-hospital mortality after VA-ECMO insertion was 6.2%, 28.1%, 51.6%, and 93.8% for AMI-ECMO score quartiles (0 to 16, 17 to 19, 20 to 26, and > 26), respectively (P < .001 for trend). The AMI-ECMO scores were also significantly associated with the estimated rate of all-cause mortality during follow-up (per 1 increase, HR, 1.11; 95%CI, 1.08-1.14; P < .001).ConclusionsThe AMI-ECMO score can help predict early prognosis in AMI patients who undergo VA-ECMO.Full English text available from:www.revespcardiol.org/en     

Short and long-term clinical impact of transcatheter aortic valve implantation in Portugal according to different access routes: Data from the Portuguese National Registry of TAVI

IntroductionThe Portuguese National Registry of Transcatheter Aortic Valve Implantation records prospectively the characteristics and outcomes of transcatheter aortic valve implantation (TAVI) procedures in Portugal.ObjectivesTo assess the 30-day and one-year outcomes of TAVI procedures in Portugal.MethodsWe compared TAVI results according to the principal access used (transfemoral (TF) vs. non-transfemoral (non-TF)). Cumulative survival curves according to access route, other procedural and clinical variables were obtained. The Valve Academic Research Consortium-2 (VARC-2) composite endpoint of early (30-days) safety was assessed. VARC-2 predictors of 30-days and 1-year all-cause mortality were identified.ResultsBetween January 2007 and December 2018, 2346 consecutive patients underwent TAVI (2242 native, 104 valve-in-valve; mean age 81±7 years, 53.2% female, EuroSCORE-II - EuroS-II, 4.3%). Device success was 90.1% and numerically lower for non-TF (87.0%). Thirty-day all-cause mortality was 4.8%, with the TF route rendering a lower mortality rate (4.3% vs. 10.1%, p=0.001) and higher safety endpoint (86.4% vs. 72.6%, p<0.001). The one-year all-cause mortality rate was 11.4%, and was significantly lower for TF patients (10.5% vs. 19.4%, p<0.002). After multivariate analysis, peripheral artery disease, previous percutaneous coronary intervention, left ventricular dysfunction and NYHA class III-IV were independent predictors of 30-day all-cause mortality. At one-year follow-up, NYHA class III-IV, non-TF route and occurrence of life-threatening bleeding predicted mortality. Kaplan-Meier survival analysis of the first year of follow-up shows decreased survival for patients with an EuroS-II>5% (p<0.001) and who underwent non-TF TAVI (p<0.001).ConclusionData from our national real-world registry showed that TAVI was safe and effective. The use of a non-transfemoral approach demonstrated safety in the short term. Long-term prognosis was, however, adversely associated with this route, with comorbidities and the baseline clinical status.     

Clinical Outcomes of the Self-Expandable Evolut R Valve Versus the Balloon-Expandable SAPIEN 3 Valve in Transcatheter Aortic Valve Implantation: A Meta-Analysis and Systematic Review

BackgroundTranscatheter aortic valve replacement (TAVR) is now indicated in patients with symptomatic aortic stenosis and low, moderate, and high surgical risk. There are multiple types of valves available in TAVR. SAPIEN 3, and Evolut R are two of the most commonly used valves.MethodsWe conducted a systematic review and meta-analysis of all studies that compared SAPIEN 3 vs Evolut R in patients undergoing TAVR. The primary endpoint of this meta-analysis was 30-day mortality. Secondary outcomes included major of life-threatening bleeding, risk of stroke, need of permanent pacemaker implantation, and risk of moderate to severe paravalvular regurgitation (PVR).ResultsWe included a total of 9 studies. One study was a randomized clinical trial, five were prospective observational studies and three were retrospective. 30-day mortality rate was similar between SAPIEN 3 and Evolut R (odds ratio (OR) 1.19; 95% confidence interval (CI) 0.72 to 1.93; p = 0.47). The risk of major or life-threatening bleeding (OR of 0.83, 95% CI 0.50 to 1.39; p = 0.48), and the risk of stroke (OR of 0.82, 95% CI 0.38 to 1.78; p = 0.62) were also similar between the two types of valves. Compared to SAPIEN 3, Evolut R was associated with statistically significant risk of permanent pacemaker implantation (OR of 1.40, 95% CI 1.15 to 1.70; p = 0.0007), and moderate to severe PVR (OR of 2.56, 95% CI 1.14 to 5.74; p = 0.02).ConclusionsAt 30 day follow up, both Evolut R and SAPIEN 3 shared similar risks of 30-day mortality, major or life-threatening bleeding, and stroke; however greater odds of pacemaker placement implantation and moderate to severe PVR were associated with Evolut R.     

Left Ventricular Assist Devices Impact Hospital Resource Utilization Without Affecting Patient Mortality in Gastrointestinal Bleeding

Background

Left ventricular assist devices (LVADs) are being utilized for management of end-stage heart failure and require systemic anticoagulation. Gastrointestinal bleeding (GIB) is one of the most common adverse events following LVAD implantation.

Aim

To investigate the impact of continuous-flow (CF) LVAD implants on outcomes of patients admitted with GIB.

Methods

This is a cross-sectional study utilizing the Nationwide Inpatient Sample in the CF-LVAD era from 2010 to 2012. All adult admissions with a primary diagnosis of GIB were included. Among hospitalizations with GIB, patients with (cases) and without (controls) CF-LVAD implants were compared using univariate and multivariate analyses. The main outcome measurements were in-hospital mortality, length of stay, and hospitalization costs.

Results

Among 1,002,299 hospitalizations for GIB, 1112 (0.11%) patients had CF-LVADs. Bleeding angiodysplasia accounted for a majority of GIB in CF-LVAD patients (35.4% of 1112). Multivariate analysis adjusting for demographic, hospital and etiological differences, site of GIB, and patient comorbidities revealed that CF-LVADs were not adversely associated with mortality in GIB (OR 0.53, 95% CI 0.07–4.15). However, CF-LVADs independently accounted for prolonged hospitalization (3.5 days, 95% CI 2.6–4.6) and higher hospital charges ($37,032, 95% CI $7991–$66,074).

Conclusions

In patients admitted with GIB, CF-LVAD implantation accounts for higher healthcare utilization, but is not adversely associated with mortality despite therapeutic anticoagulation, increased comorbidities, and comparatively delayed endoscopy. These findings are relevant as CF-LVADs are the dominant type of LVAD and are associated with increased risk of GIB compared to their predecessors.

     

Impact of chronic kidney disease on in-hospital outcomes following left ventricular assist device placement: A national perspective

BackgroundLeft ventricular assist devices (LVADs) are being increasingly utilized for the treatment of stage-D heart failure. A LVAD is a battery-operated, mechanical pump that assists in pumping blood out of the left ventricle (LV) into the aorta, thereby lowering left ventricular burden. Prevalence of chronic kidney disease (CKD) is increasing in patients receiving LVAD.ObjectivesThe purpose of this study was to compare in-hospital mortality and hospitalization expenditure associated with CKD in patients receiving LVAD implantation.MethodsUsing the National Inpatient Sample from January 2012 through September 2015, index hospitalizations for LVAD were identified. Based on kidney function, LVAD recipients were divided into three groups: Group 1 included patients with normal renal function or CKD stages I–III. Groups 2 and 3 comprised of patients with CKD stage IV/V, and end-stage renal disease on dialysis respectively.ResultsA total of 20,656 patients received LVAD during the study period. Mean age was 56.1 years; 76.8% were men. In a fully adjusted model, in-hospital mortality was higher in group 2 (OR: 1.33, CI: 1.16–1.50) and highest in group 3 (OR: 8.95, CI: 6.90–11.61). Similarly, the length of hospitalization, and hospitalization cost were higher in group 2 and highest in group 3.ConclusionDespite improving outcomes in patients receiving LVAD, CKD remained a significant health problem. Worsening in-hospital outcomes paralleling the degree of kidney dysfunction were observed in patients receiving LVADs in this study.     

Cinética del lactato para el pronóstico en el shock cardiogénico asistido con oxigenador extracorpóreo de membrana venoarterial

Introduction and objectivesLactate and its evolution are associated with the prognosis of patients in shock, although there is little evidence in those assisted with an extracorporeal venoarterial oxygenation membrane (VA-ECMO). Our objective was to evaluate its prognostic value in cardiogenic shock assisted with VA-ECMO.MethodsStudy of patients with cardiogenic shock treated with VA-ECMO for medical indication between July 2013 and April 2021. Lactate clearance was calculated: [(initial lactate ? 6 h lactate) / initial lactate × exact time between both determinations].ResultsFrom 121 patients, 44 had acute myocardial infarction (36.4%), 42 implant during cardiopulmonary resuscitation (34.7%), 14 pulmonary embolism (11.6%), 14 arrhythmic storm (11.6%), and 6 fulminant myocarditis (5.0%). After 30 days, 60 patients (49.6%) died, mortality was higher for implant during cardiopulmonary resuscitation than for implant in spontaneous circulation (30 of 42 [71.4%] vs 30 of 79 [38.0%], P = .030). Preimplantation GPT and lactate (both baseline, at 6 hours, and clearance) were independently associated with 30-day mortality. The regression models that included lactate clearance had a better predictive capacity for survival than the ENCOURAGE and ECMO-ACCEPTS scores, with the area under the ROC curve being greater in the model with lactate at 6 h.ConclusionsLactate (at baseline, 6 h, and clearance) is an independent predictor of prognosis in patients in cardiogenic shock supported by VA-ECMO, allowing better risk stratification and predictive capacity.     

Clinical Impact of Diabetes Mellitus on Short-Term Outcomes andIn-Hospital Mortality of Cardiac Mechanical Support with Left Ventricular Assist Device (LVAD): A Retrospective Study from a National Database

BackgroundCardiac support with left ventricular assist devices (LVAD) is a growing field. LVAD are increasingly used for patients with advanced congestive heart failure. Multiple studies have evaluated the outcomes of cardiac support with LVAD in patients with and without diabetes mellitus (DM), yet we still have conflicting results. This study aimed to assess the clinical impact of diabetes mellitus on patients undergoing cardiac support with LVAD.MethodsDiabetic patients who underwent mechanical support with LVAD between 2011 and 2014 were identified in the National Inpatient Sample (NIS) database using the International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM). The primary outcome was the effect of diabetes mellitus on inpatient mortality. Secondary outcomes were the impact of diabetes on other immediate post-LVAD complications and the cost of hospitalization. Multivariable logistic regression models analysis was performed to address potential confounding.ResultsAfter adjusting for patient-level and hospital-level characteristics, diabetic patients who underwent cardiac support with LVAD have no significant increase in in-hospital mortality (OR: 0.79, 95% CI (0.57–1.10), p = 0.166), post-LVAD short-term complications and cost of hospitalization (OR: 0.97, 95% CI (0.93–1.01), p = 0.102).ConclusionCardiac mechanical support with LVAD implantation is feasible and relatively safe in patients with diabetes and stage-D heart failure as a bridge for transplantation or as destination therapy for patients who are not candidates for transplantation. However, further trials and studies using bigger study sample and more comprehensive databases, need to be conducted for a stronger and more valid evidence.