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Data regarding outcomes with Impella 5.5 are limited. The aim of this systematic review and meta-analysis was to summarize patient and treatment characteristics and early clinical outcomes among patients supported by Impella 5.5. A systematic literature search was conducted in PubMed, Scopus, and Cochrane databases from September 2019 to March 2023. Studies reporting outcomes in greater than or equal to 5 patients were included for review. Patient characteristics, treatment characteristics, and early clinical outcomes were extracted. Outcomes included adverse events, survival to hospital discharge, and 30 day survival. Random-effect models were used to estimate pooled effects for survival outcomes. Assessment for bias was performed using funnel plots and Egger’s tests. Fifteen studies were included for qualitative review, representing 707 patients. Mean duration of support was 9.9 ± 8.2 days. On meta-analysis of 13 studies reporting survival outcomes, survival to hospital discharge was 68% (95% confidence interval [CI], 58–78%), and 30 day survival was 65% (95% CI, 56–74%) among patients with Impella devices predominantly supported by Impella 5.5 (>60%). There was significant study heterogeneity for these outcomes. Among 294 patients with Impella 5.5 only, survival to discharge was 78% (95% CI, 72–82%) with no significant study heterogeneity. This data present early benchmarks for outcomes with Impella 5.5 as clinical experience with these devices accrues.

The Extracorporeal Life Support Organization (ELSO) maintains the world’s largest extracorporeal membrane oxygenation (ECMO) registry by volume, center participation, and international scope. This 2022 ELSO Registry Report describes the program characteristics of ECMO centers, processes of ECMO care, and reported outcomes. Neonates (0–28 days), children (29 days–17 years), and adults (≥18 years) supported with ECMO from 2009 through 2022 and reported to the ELSO Registry were included. This report describes adjunctive therapies, support modes, treatments, complications, and survival outcomes. Data are presented descriptively as counts and percent or median and interquartile range (IQR) by year, group, or level. Missing values were excluded before calculating descriptive statistics. Complications are reported per 1,000 ECMO hours. From 2009 to 2022, 154,568 ECMO runs were entered into the ELSO Registry. Seven hundred and eighty centers submitted data during this time (557 in 2022). Since 2009, the median annual number of adult ECMO runs per center per year increased from 4 to 15, whereas for pediatric and neonatal runs, the rate decreased from 12 to 7. Over 50% of patients were transferred to the reporting ECMO center; 20% of these patients were transported with ECMO. The use of prone positioning before respiratory ECMO increased from 15% (2019) to 44% (2021) for adults during the coronavirus disease-2019 (COVID-19) pandemic. Survival to hospital discharge was greatest at 68.5% for neonatal respiratory support and lowest at 29.5% for ECPR delivered to adults. By 2022, the Registry had enrolled its 200,000th ECMO patient and 100,000th patient discharged alive. Since its inception, the ELSO Registry has helped centers measure and compare outcomes across its member centers and strategies of care. Continued growth and development of the Registry will aim to bolster its utility to patients and centers.

The Jarvik 2000 bridge to transplant investigational device exemption study was a multicentered, prospective study of 150 UNOS status I patients implanted with the Jarvik 2000 between 2005 and 2012. During the study period, there were numerous modifications of the system that included converting from pin to cone bearings. Results were analyzed for three cohorts: total (n = 150), pin (n = 128), and cone (n = 22). Baseline demographics included age (52 ± 13), gender (79% male), size (BSA 1.98), and etiology (37% idiopathic dilated cardiomyopathy; 43% Ischemic). Seventy percent of patients were either INTERMACS 1 or 2. The primary endpoint—defined as successful transplantation or listing at 180 days (prespecified at 65%; 95% lower CI: 57%)—was successfully achieved for the total cohort (67.3%; 95% CI: 59.5%–74.3%; p= 0.006). In subgroup analysis of the more contemporary, cone-bearing group, the primary endpoint was met in 91% (95% CI: 72%–97.5%; p= 0.001). Compared with pin patients, cone-bearing patients had less hemolysis as well as decreased end-organ dysfunction. Functional and quality of life scores improved after implantation independent type of bearing. In conclusion, despite a particularly sick patient population, the Jarvik 2000 was shown to be effective in supporting the advanced HF patient.

In the MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3) pivotal trial, the HeartMate 3 (HM3) fully magnetically levitated left ventricular assist device (LVAD) demonstrated superiority over the axial-flow HeartMate II (HMII) LVAD. The patterns and predictors of hospitalizations with the HM3 LVAD have not been characterized.

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1067/mtc.2000.105457 Byline: B.Zane Atkins, Scott C. Silvestry, Ravi N. Samy, Ashish S. Shah, David C. Sabiston, Donald D. Glower Abstract: Introduction: Calcitonin gene-related peptide, a potent vasodilating inotropic agent, increases coronary artery perfusion when administered exogenously and reduces ischemic injury in nonmyocardial tissue. However, it is unclear whether this agent improves recovery of myocardial performance after reversible myocardial ischemia. Methods: Nine dogs underwent complete occlusion of the left anterior descending coronary artery for 15 minutes and were monitored during 24 hours of reperfusion. Calcitonin gene-related peptide (0.07 [mu]g * kg.sup.-1 * min.sup.-1), nitroglycerin (65 [mu]g * kg.sup.-1 * min.sup.-1), or saline solution placebo was infused intravenously during initial reperfusion. Ischemia/reperfusion was repeated in concurrent 24-hour periods until all animals received infusions in random order. Micromanometry and sonomicrometry determined left ventricular pressure and myocardial segment length. Myocardial performance, based on the linear relationship between stroke work and end-diastolic segment length, was estimated with the preload recruitable work area.Results were analyzed as percent control and compared statistically with the use of repeated measures analysis of variance. Results: Recovery of myocardial performance was augmented during reperfusion with calcitonin gene-related peptide infusion relative to placebo (P = .005; mean preload recruitable work area [+ or -] SE after calcitonin gene-related peptide infusion, 2484 [+ or -] 705 mm Hg at 90 minutes of reperfusion versus 1473 [+ or -] 300 mm Hg for placebo. Recovery of performance after nitroglycerin infusion was similar to recovery after placebo. Conclusions: Calcitonin gene-related peptide infusion improves recovery of contractile function in stunned myocardium. Unlike inotropic agents that impair recovery from reversible ischemia, calcitonin gene-related peptide may confer cardioprotective effects on ischemic myocardium. (J Thorac Cardiovasc Surg 2000;119:1246-54) Author Affiliation: Departments of Surgery and Biomedical Engineering, Duke University Medical Center, Durham, NC. Article History: Received 20 May 1999; Revised 8 August 1999; Revised 27 December 1999; Accepted 29 December 1999 Article Note: (footnote) [star] Supported by National Institutes of Health grants HL08902, HL09315, and HL29436 and by Specialized Center of Research (SCOR) grant HL17670., [star][star] Address for reprints: Donald D. Glower, MD, Box 3851, Duke University Medical Center, Durham, NC 27710 (E-mail: glowe001@mc.duke.edu ).

Supplemental Digital Content is available in the text.We sought to characterize patients who underwent heart transplant (HTx) following destination therapy (DT) implant in the combined ENDURANCE/ENDURANCE Supplemental Trials (DT/DT2). A post hoc analysis of the DT/DT2 trials was performed. Baseline characteristics and adverse events between the HTx and no-HTx cohorts were analyzed. Reasons for transplant were examined. Time to HTx was compared with contemporaneous HVAD BTT trial patients. Of the 604 DT/DT2 HVAD patients, 80 (13%) underwent HTx. The HTx cohort was younger (53.6 ± 11.1 vs.65.2 ± 10.8, P < 0.0001) with fewer Caucasians (60.0% vs.76.5%, P = 0.002), less ischemic cardiomyopathy (42.5% vs.58.8%, P = 0.01), and atrial fibrillation (38.8% vs.54.4%, P = 0.01). The HTx cohort had longer 6-minute walk distances (183.6 vs.38.0 m, P = 0.02). Most HTx in DT/DT2 were categorized as elective (n = 63, 79%) and, of these, 70% were due to modification of behavioral issues and weight loss. Adverse events were the main indication for urgent HTx (n = 17, 21%). Median times to HTx were longer in DT/DT2 (550.0 days) versusBTT/lateral (285.2 days). In this post hoc analysis of the DT/DT2 trials, over 1 in 10 underwent heart transplantation within 3 years of HVAD support. In DT therapy patients, consideration for transplant following DT VAD implant may be feasible.

Supplemental Digital Content is available in the text.There is limited data on the cost-effectiveness of continuous-flow left ventricular assist devices (LVAD) in the United States particularly for the bridge-to-transplant indication. Our objective is to study the cost-effectiveness of a small intrapericardial centrifugal LVAD compared with medical management (MM) and subsequent heart transplantation using the respective clinical trial data. We developed a Markov economic framework. Clinical inputs for the LVAD arm were based on prospective trials employing the HeartWare centrifugal-flow ventricular assist device system. To better assess survival in the MM arm, and in the absence of contemporary trials randomizing patients to LVAD and MM, estimates from the Seattle Heart Failure Model were used. Costs inputs were calculated based on Medicare claim analyses and when appropriate prior published literature. Time horizon was lifetime. Costs and benefits were appropriately discounted at 3% per year. The deterministic cost-effectiveness analyses resulted in $69,768 per Quality Adjusted Life Year and $56,538 per Life Year for the bridge-to-transplant indication and $102,587 per Quality Adjusted Life Year and $87,327 per Life Year for destination therapy. These outcomes signify a substantial improvement compared with prior studies and re-open the discussion around the cost-effectiveness of LVADs.

Supplemental Digital Content is available in the text.This study reports the first analysis regarding cost-effectiveness of left ventricular assist device (LVAD) implantation viathoracotomy. Cost-effectiveness of LVADs implanted viathe traditional surgical approach of sternotomy has been improved through the years because of technological advances, along with understanding the importance of patient selection and postimplant management have on positively affecting outcomes. Given the positive clinical outcomes of the thoracotomy approach, we seek to study the cost-effectiveness of a centrifugal LVAD viathis less invasive approach. We developed a Markov model. Survival and quality of life inputs (QALY) for the LVAD arm were based on data from the LATERAL clinical trial. For the Medical Management arm, survival was derived from the Seattle Heart Failure Model. The heart transplant probability was derived from INTERMACS. Survival after heart transplantation used International Society for Heart and Lung Transplantation data. Cost inputs were calculated based on Medicare data and past literature. The incremental cost-effectiveness ratio was found to be $64,632 per quality adjusted life year and $57,891 per life year in the bridge to transplant indication. These results demonstrate further improvement in the overall cost-effectiveness of LVAD therapy and confirm implantation of LVADs viaa less invasive approach as being cost-effective.

Randomized controlled trials can provide optimal clinical evidence to assess the benefits of new devices, and it is these data that often shape device usage in real-world practice. However, individual clinical trial results sometimes appear discordant for the same device, and alternative devices are sometimes not employed in similar patient populations. To make sound evidence-based decisions, clinicians routinely rely on cross-trial comparisons from different trials of similar but not identical patient populations to assess competing technology when head-to-head randomized comparisons are unavailable.

Supplemental Digital Content is available in the text.

Advanced heart failure patients who are classified as bridge to transplant (BTT) often remain on mechanical circulatory support (MCS) for long durations because of the limited supply of donor organs. Here, we present the outcomes of patients who have been supported by the HeartWare ventricular assist device system for more than 2 years. In the HeartWare BTT and continued access protocol trial, 74 of the 382 total patients (19.4%) had more than 2 years of MCS with a mean time of 1,045 days on device. The long-term group was more frequently female, was nonwhite, and had Interagency Registry for Mechanically Assisted Circulatory Support profiles 4–7. Postimplant adverse event rates including bleeding, cardiac arrhythmia, infection, stroke, renal dysfunction, and right heart failure were less frequent in the long-term cohort. In addition, the long-term cohort displayed significant improvements in Kansas City Cardiomyopathy Questionnaire Overall Summary Score, EuroQOL-5D Overall Health State Score, and 6 minute walk scores from baseline values. The rate of heart transplantation was lower for the long-term cohort, which may have been a result of their sex and blood type. However, most of these patients are still listed for cardiac transplantation and maintained their quality of life profiles through 3 years of support.

This study evaluated gastrointestinal bleeding (GIB) in patients receiving the HeartWare HVAD System (HeartWare Inc., Framingham, Massachusetts) in the pivotal BTT (Bridge to Transplant) trial and under the continued access protocol (CAP).

This study evaluated the Heartmate Risk Score (HMRS) and its potential benefits in clinical practice.

Objective We sought to study the outcomes of redo-mitral valve surgery in patients with pulmonary hypertension.Methods We reviewed data on redo mitral valve surgery in patients with pulmonary hypertension measured by Swan-Ganz catheter (mean pulmonary artery pressure ≥ 25 mm Hg or systolic pulmonary artery pressure ≥ 40 mm Hg).Results Between 1996 and 2010, 637 patients underwent 658 redo mitral valve operations; 138 of them had pulmonary hypertension. The mean patient age was 61.3 (13.9) years, with mean left ventricular ejection fraction of 47.6% (13.2%). The mean systolic pulmonary artery pressure was 61.5 (16.8) mm Hg, and mean pulmonary artery pressure was 40.8 (11.6) mm Hg. Patients had one (71%, 98/138), two (23.9%, 33/138), and three (5.1%, 7/138) previous mitral valve operations. Thirty-day mortality was 10.1% (14/138). Multivariate predictors of 30-day mortality were chronic renal failure [odds ratio (OR), 8.041; P= 0.022], peripheral vascular disease (OR, 5.976; P= 0.025), previous mitral valve replacement (OR, 9.034; P= 0.014), and increasing age (OR, 1.077; P= 0.013). The severity of pulmonary hypertension did not impact 30-day (P= 0.314) or late mortality (P= 0.860). Kaplan-Meier survival rates at 1, 3, and 5 years were 76.6% (n = 99), 65.7% (n = 62), and 55.9% (n = 41), respectively.Conclusions Patients with pulmonary hypertension that undergo redo mitral valve surgery have a 55.9% 5-year survival rate. Increasing age, chronic renal insufficiency, peripheral vascular disease, and preexisting mitral valve prosthesis are associated with early mortality. The severity of pulmonary hypertension does not affect operative mortality rates, but it may decrease 1-, 3-, and 5-year survival.

Introduction:Although significant cardiac reverse remodeling is a prerequisite for a left ventricular (LV) assist device (LVAD) patient to be considered for device weaning, multiple factors including patient goals, physician comfort, and center experience, weigh in on this complex decision. Existing predictive models defining recovery as device removal may under detect patients that could benefit from a targeted bridge to recovery strategy. We sought to derive and validate a predictive tool to identify patients prone to reverse remodel, independent of the complex decision of device explant.Methods:Heart failure patients (N=782) requiring LVAD were enrolled at the Utah Transplant Affiliated Hospitals (n=537) and 5 US programs (n=245). Baseline characteristics were recorded. The primary outcome was ‘responder’ incidence, defined as follow-up LV ejection fraction (LVEF) ≥40% and LV end-diastolic diameter (LVEDD) ≤6 cm within one year on LVAD support. Bootstrap imputation and lasso variable selection techniques were used to derive a predictive model which was then validated. A predictive calculator was developed and patients were classified into groups with varying potential for reverse remodeling.Results:Patients were predominantly white (84%), males (82%), aged 56±1 years. Overall, 14.8% patients were identified as responders. A subset of 10 pre-operative variables associated with reverse remodeling were included in the multivariate model achieving an optimism-corrected C-statistic of 0.75 (95% CI: 0.73-0.84) (Figure).Conclusions:The UCAR calculator is a machine learning-based multicenter and validated risk tool, implementing routine pre-operative clinical data, effectively stratifying patients into groups with varying potential for reverse remodeling. This tool can be useful in selecting patients to implement diagnostic and therapeutic protocols to promote reverse remodeling and myocardial recovery.

This study evaluated clinical outcomes associated with erythropoiesis stimulating agent (ESA) use in left ventricular assist devices (LVAD)–supported patients.

Evaluating cardiac gene therapy in the intact animal requires an index of cardiac function capable of detecting regional differences in contractility in a load-independent fashion. Potentially load-insensitive measures of ventricular performance were therefore evaluated in 10 open- and closed-chested, anesthetized rabbits. LV transmural pressure and myocardial segment length were measured using micromanometry and sonomicrometry during steady-state and transient inferior vena caval occlusion, over a range of inotropic and loading conditions. For each intervention, segmental stroke work was calculated as the area within the left ventricular transmural pressure-length loops at a given end-diastolic segment length during inferior vena caval occlusion; regression analysis was applied to obtain the linear Frank–Starling relationship. In both open- and closed-chested states, these relationships were highly linear (r=0.97±0.1) and reproducible. The slope of the linear relationship between segmental stroke work and end-diastolic segment length increased significantly with calcium and epinephrine infusions (P<0.05vcontrol) but was not significantly altered by decreased afterload or increased afterload (P>0.4). The x-intercept was not significantly altered by changes in intropy or afterload (P>0.4). These data validate the linear Frank–Starling relationship and the slope, MW, as a load-insensitive index of contractility in the intact rabbit. This study presents a novel approach to the quantification of regional cardiac function in smaller animals.

We describe the use of an Impella 5.0 for mechanical support in acute cardiogenic shock after an acute myocardial infarction. A 61-year-old man with a history of severe coronary artery disease who underwent coronary artery bypass grafting with ischemic cardiomyopathy presented with cardiogenic shock after an ST-elevation myocardial infarction. An Impella Recover LP 5.0 (Abiomed, Danvers, MA USA) was inserted via a right axillary side graft, using transesophageal echocardiographic and fluoroscopic guidance. The patient remained in the intensive care unit, where he required a tracheostomy to beweaned off the ventilator. He required renal replacement therapy with subsequent complete recovery. His Impella support was weaned, and on postoperative day 35, the device was removed. The patient developed axillary thrombosis the morning after removal, requiring thrombectomy. Discharge echocardiogram showed mild left ventricular enlargement with global hypokinesis and left ventricular ejection fraction of 25%. The Impella 5.0 device can safely and effectively be used in the long-term support of cardiogenic shock.

Patients with suspected esophageal perforations are routinely evaluated with a swallow study using a water-soluble contrast medium followed by thin-barium administration when the first fails to demonstrate a leak. Intrapleural barium instillation has been historically correlated with mild degree of pleural inflammation and a low-grade talclike reactive process. Still, if administered in excessive quantities, it may contribute to complicate the clinical scenario of pleural contamination secondary to the perforated esophagus. We report the case of a patient that presented with a malignant esophageal perforation and developed a trapped lung from extensive pleural contamination with barium sulfate that required video-assisted thoracic drainage and decortication with successful reexpansion of the lung and resolution of the acute symptoms.

Introduction:Caregivers (CGs) provide essential support to patients with advanced heart failure (HF), yet caregiving can be burdensome and adversely affect CG?s lives. Understanding CG burden, specifically time spent caring for patients and difficulty of tasks, may inform CG support needs before and early after cardiac surgery. We compared CG burden before and 6 months after surgery for heart transplantation (HT), with or without baseline mechanical circulatory support (MCS), and destination therapy (DT) MCS.Methods:Between 10/1/15?12/31/18, we enrolled 302 CGs of HF patients from 12 U.S. hospitals: 193 awaiting HT (89 with and 104 without MCS), and 109 scheduled for DT MCS. At baseline and 3 and 6 months after surgery, CGs completed the Oberst Caregiving Burden Scale (OCBS) which has 15 items with 2 subscales: (1) time: range=1-5, higher score=more time spent on task and (2) difficulty: range=1-5, higher score=higher difficulty of task. Analyses included t-tests, chi-square tests, and baseline-adjusted linear regression models.Results:Overall, CGs were aged 61.0?10.3 years, and the majority were spouses (85%), female (86%), and white (86%). Time spent on caregiving was moderate and decreased significantly from before to 6 months after surgery for both HT groups, but not for the DT MCS cohort. See Figure. Levels of task difficulty were low and did not change over time for all groups. DT MCS CGs reported significantly more time and difficulty in caregiving than HT non-MCS CGs at baseline and follow-up. See Figure.Conclusions:While CG time on tasks decreased from before to early after surgery in all three groups, task difficulty was greater for DT MCS vs HT non-MCS CGs. Understanding caregiver burden in CGs of patients who undergo advanced cardiac surgical procedures, especially DT MCS CGs, may inform identification of support options and potentially reduce burden.

Calcitonin gene-related peptide (CGRP) has been found to have inotropic properties and a short half-life. CGRP has been demonstrated to reduce ischemic injury in tissue flaps as well as to increase coronary artery flow, while other available inotropes have been shown to impair recovery from myocardial ischemia. Yet, a therapeutic role for CGRP in myocardial ischemia has not been defined. Therefore, CGRP was compared to placebo in nine chronically instrumented conscious dogs who underwent two 15 minute left anterior descending coronary artery occlusions separated by at least 24 hours of reperfusion. Left ventricular transmural pressure and myocardial segment length were measured at control and during reperfusion. Either CGRP (0.07 μg/kg/min) or saline placebo was randomly chosen and continuously infused from 45 to 105 minutes of reperfusion. The alternative infusion was given during the second study. Regional function was assessed using preload recruitable work area (PRWA), a load-insensitive measure of regional myocardial performance. PRWA was calculated as the area beneath the linear stroke work vs. end-diastolic length relationship. Data are mean PRWA (% of control) ± SEM for the 9 dogs.90 Min3 Hours8 Hours24 HoursPlacebo89 ± 782 ± 894 ± 1079 ± 7CGRP*155 ± 22*115 ± 9*118 ± 12*108 ± 15*p &lt; 0.05 vs. placebo

Whether biological or mechanical valves should be used in patients on chronic dialysis therapy remains to be clearly defined. Therefore, a retrospective review was performed of all 19 patients from our institution with end-stage renal disease (ESRD) on chronic peritoneal or hemodialysis undergoing aortic (N=12) or mitral (N=5) valve replacement. Two patients underwent aortic and mitral valve replacement. The 9 biological (BV) and 10 mechanical (MV) valve patients had similar ages (56.5 vs. 56.6 yrs) and cardiovascular risk factors. BV and MV patients combined had an estimated Kaplan-Meier survival of 60±12% at 12 months and 42±14% at 60 months with no significant difference in survival between BV and MV patients. MV patients had a significantly higher rate of postoperative cerebrovascular accidents or bleeding complications (10/10 vs. 0/9; χ2=17.0, P&lt;0.001). MV patients on hemodialysis required frequent reoperation for hemorrhage or infection at the access site. Furthermore, there were no subsequent reoperations required for BV failure. Only one BV developed prosthetic dysfunction lat (56 months).