Use of short-term MCS in the United States has increased rapidly, whereas rates of in-hospital mortality have decreased. These changes have taken place in the context of declining hospital costs associated with short-term MCS.
Recent studies have shown the benefits of extracorporeal membrane oxygenation (ECMO) in supporting adults with severe respiratory or cardiac failure refractory to conventional treatments. The purpose of this investigation was to analyze the usage of ECMO in adults to identify recent trends within the United States. The usage of ECMO, the survival rates, and the hospitalization costs from 2006 to 2011 were analyzed using the Nationwide Inpatient Sample from the Healthcare Cost and Utilization Project. The rate of ECMO cases per million adult discharges increased 433% from 11.4 (95% confidence interval, 6.1-16.8) in 2006 to 60.9 (95% confidence interval, 28.1-93.7) in 2011 (p for trend = 0.001). There was a trend toward improved survival rates, but this was not statistically significant (p for trend = 0.14). The costs per day have not changed significantly (p for trend = 0.07) nor have the total costs per patient (p for trend = 0.87). In conclusion, there was a huge increase in the usage of ECMO in adults from 2006 to 2011 with a trend toward improved survival rates and no increase in hospitalization costs.
Background
Right ventricular (RV) failure is a significant complication following implantation of a left ventricular assist device (LVAD). It is therefore important to identify patients at risk a-priori. However, prognostic models derived from multivariate analyses have had limited predictive power.
Methods
This study retrospectively analyzed 183 patient records of LVAD recipients between May 1996 and Oct. 2009; 27 of which later required a right ventricular assist device (RVAD+) and 156 remained on LVAD only (RVAD−) until the time of transplantation or death. A decision tree model was constructed to represent combinatorial nonlinear relationships of the preoperative data that are predictive of the need for RVAD support.
Results
An optimal set of eight preoperative variables were identified: transpulmonary gradient, age, right atrial pressure, international normalized ratio, heart rate, white blood cell count, alanine aminotransferase and the number of inotropic agents. The resultant decision tree, comprised of 28 branches and 14 leaves, identified RVAD+ patients with 85% sensitivity, RVAD− patients with 83% specificity, and exhibited an area under the ROC curve of 0.87.
Conclusions
The decision tree model developed in this study exhibited several advantages over existing risk scores. Quantitatively, it provided improved prognosis of RV support by encoding the nonlinear, synergic interactions among preoperative variables. Because of its intuitive structure, it more closely mimics clinical reasoning and therefore can be more readily interpreted. Further development with additional multi-center, longitudinal data may provide a valuable prognostic tool for triage of LVAD therapy, and potentially improve outcomes.
We recently demonstrated that electroporation enhances transfection in a mouse wound-healing model. Keratinocyte growth factor (KGF) is an inducer of epithelial cell proliferation and differentiation and has been shown to be under expressed in the wounds of diabetic individuals. We hypothesized that KGF delivered into an excisional wound via naked DNA injection with subsequent electroporation would be a novel and potentially effective method to enhance wound closure in a diabetic mouse model. ELISA assays confirmed production of KGF protein in cultured mouse cells and RT-PCR assays confirmed KGF mRNA in skin samples taken from mice. In all, 32 genetically diabetic mice were given two identical excisional wounds of their dorsum and split into two groups with one group receiving KGF DNA injection and electroporation with the other group receiving no treatment. Over 90% of wounds healed in the presence of KGF and electroporation versus 40% in the untreated group by day 12. Histological analysis of the wounds demonstrated that untreated wounds contained microulcers with thin or incomplete epithelium with unresolved inflammation as compared to treated wounds where intact and mature epithelium was observed. Taken together these findings suggest that a single injection of KGF DNA encoded on a plasmid coupled with electroporation improves and accelerates wound closure in a delayed wound-healing model.
IMPORTANCE Left ventricular assist devices (LVADs) are well established in the treatment of advanced heart failure, but it is unclear whether outcomes are different based on the intended goal of therapy in patients who are eligible vs ineligible for heart transplant. OBJECTIVE To determine whether clinical outcomes in the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) trial differed by preoperative categories of bridge to transplant (BTT) or bridge to transplant candidacy (BTC) vs destination therapy (DT). DESIGN, SETTING, AND PARTICIPANTS This study was a prespecified secondary analysis of the MOMENTUM 3 trial, a multicenter randomized clinical trial comparing the magnetically levitated centrifugal-flow HeartMate 3 (HM3) LVAD to the axial-flow HeartMate II (HMII) pump. It was conducted in 69 centers with expertise in managing patients with advanced heart failure in the United States. Patients with advanced heart failure were randomized to an LVAD, irrespective of the intended goal of therapy (BTT/BTC or DT). MAIN OUTCOMES AND MEASURES The primary end point was survival free of disabling stroke or reoperation to remove or replace a malfunctioning device at 2 years. Secondary end points included adverse events, functional status, and quality of life. RESULTS Of the 1020 patients with implants (515 with HM3 devices [50.5%] and 505 with HMII devices [49.5%]), 396 (38.8%) were in the BTT/BTC group (mean [SD] age, 55 [12] years; 310 men [78.3%]) and 624 (61.2%) in the DT group (mean [SD] age, 63 [12] years; 513 men [82.2%]). Of the patients initially deemed as transplant ineligible, 84 of 624 patients (13.5%) underwent heart transplant within 2 years of LVAD implant. In the primary end point analysis, HM3 use was superior to HMII use in patients in the BTT/BTC group (76.8% vs 67.3% for survival free of disabling stroke and reoperation; hazard ratio, 0.62 [95% CI, 0.40-0.94]; log-rank P = .02) and patients in the DT group (73.2% vs 58.7%; hazard ratio, 0.61 [95% CI, 0.46-0.81]; log-rank P < .001). For patients in both BTT/BTC and DT groups, there were not significantly different reductions in rates of pump thrombosis, stroke, and gastrointestinal bleeding with HM3 use relative to HMII use. Improvements in quality of life and functional capacity for either pump were not significantly different regardless of preimplant strategy. CONCLUSIONS AND RELEVANCE In this trial, the superior treatment effect of HM3 over HMII was similar for patients in the BTT/BTC or DT groups. It is possible that use of arbitrary categorizations based on current or future transplant eligibility should be clinically abandoned in favor of a single preimplant strategy: to extend the survival and improve the quality of life of patients with medically refractory heart failure.
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