Trends in the use of percutaneous ventricular assist devices: analysis of national inpatient sample data, 2007 through 2012.
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ABSTRACT:
SUBMITTER: Khera R
PROVIDER: S-EPMC4780323 | biostudies-literature | 2015 Jun
REPOSITORIES: biostudies-literature
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Trends in the use of percutaneous ventricular assist devices: analysis of national inpatient sample data, 2007 through 2012.
Khera Rohan R Cram Peter P Lu Xin X Vyas Ankur A Gerke Alicia A Rosenthal Gary E GE Horwitz Phillip A PA Girotra Saket S
JAMA internal medicine 20150601 6
<h4>Importance</h4>Percutaneous ventricular assist devices (PVADs) provide robust hemodynamic support compared with intra-aortic balloon pumps (IABPs), but clinical use patterns are unknown.<h4>Objective</h4>To examine contemporary patterns in PVAD use in the United States and compare them with use of IABPs.<h4>Design, setting, and participants</h4>Retrospective study of adults older than 18 years who received a PVAD or IABP while hospitalized in the United States (2007-2012).<h4>Main outcomes a ...[more]
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Project description:Data on relative safety, efficacy, and role of different percutaneous left ventricular assist devices for hemodynamic support during the ventricular tachycardia (VT) ablation procedure are limited.We performed a multicenter, observational study from a prospective registry including all consecutive patients (N=66) undergoing VT ablation with a percutaneous left ventricular assist devices in 6 centers in the United States. Patients with intra-aortic balloon pump (IABP group; N=22) were compared with patients with either an Impella or a TandemHeart device (non-IABP group; N=44). There were no significant differences in the baseline characteristics between both the groups. In non-IABP group (1) more patients could undergo entrainment/activation mapping (82% versus 59%; P=0.046), (2) more number of unstable VTs could be mapped and ablated per patient (1.05±0.78 versus 0.32±0.48; P<0.001), (3) more number of VTs could be terminated by ablation (1.59±1.0 versus 0.91±0.81; P=0.007), and (4) fewer VTs were terminated with rescue shocks (1.9±2.2 versus 3.0±1.5; P=0.049) when compared with IABP group. Complications of the procedure trended to be more in the non-IABP group when compared with those in the IABP group (32% versus 14%; P=0.143). Intermediate term outcomes (mortality and VT recurrence) during 12±5-month follow-up were not different between both groups. Left ventricular ejection fraction ?15% was a strong and independent predictor of in-hospital mortality (53% versus 4%; P<0.001).Impella and TandemHeart use in VT ablation facilitates extensive activation mapping of several unstable VTs and requires fewer rescue shocks during the procedure when compared with using IABP.
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Project description:BackgroundPercutaneous ventricular assist devices (PVADs) have been replacing intra-aortic balloon pumps for hemodynamic support during percutaneous coronary intervention (PCI), even though data supporting a benefit for hard clinical end points remain limited. We evaluated diffusion of PVADs across US markets and examined the association of market utilization of PVAD with mortality and cost.MethodsUsing the 2013 to 2019 Medicare data, we identified all patients aged ≥65 years who underwent PCI with either a PVAD or intra-aortic balloon pump. We used hospital referral region to define regional health care markets and categorized them in quartiles based on the proportional use of PVADs during PCI. Multilevel models were constructed to determine the association of patient, hospital, and market factors with utilization of PVADs and the association of PVAD utilization with 30-day mortality and cost.ResultsA total of 79 176 patients underwent PCI with either intra-aortic balloon pump (47 514 [60.0%]) or PVAD (31 662 [40.0%]). The proportion of PCI procedures with PVAD increased over time (17% in 2013 to 57% in 2019; P for trend, <0.001), such that PVADs overtook intra-aortic balloon pump for hemodynamic support during PCI in 2018. There was a large variation in PVAD utilization across markets (range, 0%-85%), which remained unchanged after adjustment of patient characteristics (median odds ratio, 2.05 [95% CI, 1.91-2.17]). The presence of acute myocardial infarction, cardiogenic shock, and emergent status was associated with a 45% to 50% lower odds of PVAD use suggesting that PVADs were less likely to be used in the sickest patients. Greater utilization of PVAD at the market level was not associated with lower risk mortality but was associated with higher cost.ConclusionsAlthough utilization of PVADs for PCI continues to increase, there is large variation in PVAD utilization across markets. Greater market utilization of PVADs was not associated with lower mortality but was associated with higher cost.
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Project description:BackgroundRecent studies describe an emerging role for percutaneous left ventricular assist devices such as Impella CP® as rescue therapy for refractory cardiac arrest. We hypothesized that the addition of mechanical chest compressions to percutaneous left ventricular assist device assisted CPR would improve hemodynamics by compressing the right ventricle and augmenting pulmonary blood flow and left ventricular filling. We performed a pilot study to test this hypothesis using a swine model of prolonged cardiac arrest.MethodsEight Yorkshire swine were anesthetized, intubated, and instrumented for hemodynamic monitoring. They were subjected to untreated ventricular fibrillation for 5.75 (SD 2.90) minutes followed by mechanical chest compressions for a mean of 20.0 (SD 5.0) minutes before initiation of percutaneous left ventricular assist device. After percutaneous left ventricular assist device initiation, mechanical chest compressions was stopped (n = 4) or continued (n = 4). Defibrillation was attempted 4, 8 and 12 minutes after initiating percutaneous left ventricular assist device circulatory support.ResultsThe percutaneous left ventricular assist device + mechanical chest compressions group had significantly higher percutaneous left ventricular assist device flow prior to return of spontaneous heartbeat at four- and twelve-minutes after percutaneous left ventricular assist device initiation, and significantly higher end tidal CO2 at 4-minutes after percutaneous left ventricular assist device initiation, when compared with the percutaneous left ventricular assist device alone group. Carotid artery flow was not significantly different between the two groups.ConclusionThe addition of mechanical chest compressions to percutaneous left ventricular assist device support during cardiac arrest may generate higher percutaneous left ventricular assist device and carotid artery flow prior to return of spontaneous heartbeat compared to percutaneous left ventricular assist device alone. Further studies are needed to determine if this approach improves other hemodynamic parameters or outcomes after prolonged cardiac arrest.
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Project description:Worldwide, the left ventricular assist device Impella® (Abiomed, Danvers, MA, USA) is increasingly implanted in patients with acute cardiogenic shock or undergoing high-risk cardiac interventions. Despite its long history of use, few studies have assessed its safety and possible complications associated with its use. All patients treated with a left-sided Impella® device at the University Hospital of Basel from 1 January 2011 to 31 December 2019 were enrolled. The primary endpoint was the composite rate of mortality and adverse events (bleeding, acute kidney injury, and limb ischemia). Out of 281 included patients, at least one adverse event was present in 262 patients (93%). Rates of in-hospital, 90-day, and one-year mortality were 48%, 47%, and 50%, respectively. BARC type 3 bleeding (62%) and hemolysis (41.6%) were the most common complications. AKI was observed in 50% of all patients. Renal replacement therapy was required in 97 (35%) of all patients. Limb ischemia occurred in 13% of cases. Bleeding and hemolysis are common Impella®-associated complications. Additionally, we found a high rate of AKI. A careful selection of patients receiving microaxial LV support and defining the indication for its use are essential measures to be taken for the benefits to outweigh potential complications.
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Project description:Background:Understanding racial differences in outcomes for atrial fibrillation (AF) may guide interventions to diminish health inequities. Methods and Results:In a retrospective, cross-sectional study of adults hospitalized with a principal diagnosis of AF using the 2001-2012 National Inpatient Sample, we assessed racial differences for in-hospital. We accounted for case-mix and clustering by race within hospitals to estimate odds ratios (OR) for death associated with individual patient race and hospital racial composition. We identified 676,567 hospitalizations (mean age 71.8 years, 53.6% women) with principal diagnosis of AF (84.2% White, 7.1% Black, 5.0% Hispanic). Black (vs. White) race was associated with 1.63-fold (95% CI, 1.50-1.78) risk of death. Other races had similar risk of death as Whites. Risk of death for Blacks (vs. Whites) declined over time [2001: OR 1.78(95% CI 1.31-2.43); 2012: OR 1.23(95% CI 0.92-1.64)]. Racial differences in deaths within hospitals narrowed, while hospitals with larger proportions of Blacks had persistently worse outcomes than hospitals with fewer Blacks (OR 1.08 per 10% increase in Blacks in 2001 and 2012). Conclusion:Black patients with a principal diagnosis of AF were more likely to suffer in-hospital death than Whites. Our findings suggest racial disparities based upon individual patients' race improved over time, but outcomes were persistently worse at hospitals with higher proportions of Black patients, regardless of patients' races.
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Project description:This review provides a comprehensive overview of the past 25+ years of research into the development of left ventricular assist device (LVAD) to improve clinical outcomes in patients with severe end-stage heart failure and basic insights gained into the biology of heart failure gleaned from studies of hearts and myocardium of patients undergoing LVAD support. Clinical aspects of contemporary LVAD therapy, including evolving device technology, overall mortality, and complications, are reviewed. We explain the hemodynamic effects of LVAD support and how these lead to ventricular unloading. This includes a detailed review of the structural, cellular, and molecular aspects of LVAD-associated reverse remodeling. Synergisms between LVAD support and medical therapies for heart failure related to reverse remodeling, remission, and recovery are discussed within the context of both clinical outcomes and fundamental effects on myocardial biology. The incidence, clinical implications and factors most likely to be associated with improved ventricular function and remission of the heart failure are reviewed. Finally, we discuss recognized impediments to achieving myocardial recovery in the vast majority of LVAD-supported hearts and their implications for future research aimed at improving the overall rates of recovery.
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Project description:This study sought to examine trends in mortality, readmission, and costs among Medicare beneficiaries receiving ventricular assist devices (VADs) and associations between hospital-level procedure volume and outcomes.VADs are an option for patients with advanced heart failure, but temporal changes in outcomes and associations between facility-level volume and outcomes are poorly understood.This is a population-based, retrospective cohort study of all fee-for-service Medicare beneficiaries with heart failure who received an implantable VAD between 2006 and 2011. We used Cox proportional hazards models to examine temporal changes in mortality, readmission, and hospital-level procedure volume.Among 2,507 patients who received a VAD at 103 centers during the study period, the in-hospital mortality decreased from 30% to 10% (p < 0.001), the 1-year mortality decreased from 42% to 26% (p < 0.001), and the all-cause readmission was frequent (82% and 81%; p = 0.70). After covariate adjustment, in-hospital and 1-year mortality decreased (p < 0.001 for both), but the all-cause readmission did not change (p = 0.82). Hospitals with a low procedure volume had higher risks of in-hospital mortality (risk ratio: 1.72; 95% confidence interval [CI]: 1.28 to 2.33) and 1-year mortality (risk ratio: 1.55; 95% CI: 1.24 to 1.93) than high-volume hospitals. Procedure volume was not associated with risk of readmission. The greatest cost was from the index hospitalization and remained unchanged ($204,020 in 2006 and $201,026 in 2011; p = 0.21).Short- and long-term mortality after VAD implantation among Medicare beneficiaries improved, but readmission remained similar over time. A higher volume of VAD implants was associated with lower risk of mortality but not readmission. Costs to Medicare have not changed in recent years.
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Project description:ImportanceInformation regarding the performance and outcomes of noncardiac surgery (NCS) in patients with left ventricular assist devices (LVADs) is scarce, with limited longitudinal follow-up data that are mostly limited to single-center reports.ObjectiveTo examine the trends, patient characteristics, and outcomes associated with NCS among patients with LVAD.Design, setting, and participantsThis cohort study examined patients enrolled in Medicare undergoing durable LVAD implantation from January 2012 to November 2017 with follow-up through December 2017. The study included all Medicare Provider and Analysis Review Part A files for the years 2012 to 2017. Patients identified by International Classification of Diseases, Ninth Revision Clinical Modification (ICD-9-CM) and International Classification of Diseases, Tenth Revision (ICD-10) procedure codes for new LVAD implantation were included. Data analysis was performed from November 2019 to February 2020.ExposuresNCS procedures were identified using the ICD-9-CM and ICD-10 procedural codes and divided into elective and urgent or emergent.Main outcomes and measuresThe primary outcome was major adverse cardiovascular events (MACEs), defined as in-hospital or 30-day all-cause mortality, ischemic stroke, or intracerebral hemorrhage after NCS. Early (<60 days after NCS) and late (≥60 days after NCS) mortality after NCS were analyzed in both subgroups using time-varying covariate and landmark analysis using patients who did not undergo NCS as reference.ResultsOf the 8118 patients with LVAD (mean [SD] age, 63.4 [10.8] years; 6484 men [79.9%]), 1326 (16.3%, or approximately 1 in 6) underwent NCS, of which 1000 procedures (75.4%) were emergent or urgent and 326 (24.6%) were elective. There was no difference in age between patients who underwent NCS and patients who did not (mean [SD] age, 63.6 [10.6] vs 63.4 [10.9] years). The number of NCS procedures among patients with LVAD increased from 64 in 2012 to 304 in 2017. The median (interquartile range) time from LVAD implantation to NCS was 309 (133-606) days. The most frequent type of NCS was general (613 abdominal, pelvic, and gastrointestinal procedures [46.2%]). Perioperative MACEs occurred in 169 patients (16.9%) undergoing emergent or urgent NCS and 23 patients (7.1%) undergoing elective NCS. Urgent or emergent NCS was associated with higher mortality early (adjusted hazard ratio [aHR], 8.78; 95% CI, 7.20-10.72; P < .001) and late (aHR, 1.71; 95% CI, 1.53-1.90; P < .001) after NCS compared with patients with LVAD who did not undergo NCS. Elective NCS was also associated with higher mortality early (aHR, 2.65; 95% CI, 1.74-4.03; P < .001) and late (aHR, 1.29; 95% CI, 1.07-1.56; P = .008) after NCS.Conclusions and relevanceOne of 6 patients with LVAD underwent NCS. Perioperative MACEs were frequent. Higher mortality risk transcended the early postoperative period in urgent or emergent and elective surgical procedures.
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