Percutaneous Ventricular Assist Device Research Articles

Prevalence of bleeding events in real-world Japanese registry for Percutaneous Ventricular Assist Device.

Bleeding complication is a critical risk factor for outcomes of acute heart failure patients requiring mechanical circulatory support (MCS), including percutaneous catheter-type heart pumps (Impella). The Japanese registry for Percutaneous Ventricular Assist Device (J-PVAD) is an ongoing, large-scale, real-world registry to characterize Japanese patients requiring Impella. Here we analyzed bleeding complication profiles in patients who received Impella. All consecutive Japanese patients who received Impella from October 2017 to January 2020 were enrolled. The 30-day survival and bleeding complications were analyzed. A total of 1344 patients were included: 653 patients received Impella alone, 685 patients received a combination of veno-arterial extracorporeal membrane oxygenation and Impella (ECPELLA), and 6 patients had failed Impella delivery. Overall 30-day survival was 67.0%, with Impella alone at 81.9% and ECPELLA at 52.7%. Overall bleeding/hematoma adverse events with a relation or not-excluded relation to Impella was 6.92%. Among them, the rates of hematoma and bleeding from medical device access sites were 1.41% and 4.09%, respectively. There was no difference between etiologies for these events. This study represents the first 3-year survival and the safety profile focused on bleeding adverse events from the J-PVAD registry. The results show that the real-world frequency of bleeding adverse events for patients who received Impella was an expected range from previous reports, and future real-world studies should aim to expand this data set to improve outcomes and adverse events.

Development and Validation of a Risk Score Predicting Death Without Transplant in Adult Heart Transplant Candidates

The US heart allocation system prioritizes medically urgent candidates with a high risk of dying without transplant. The current therapy-based 6-status system is susceptible to manipulation and has limited rank ordering ability. To develop and validate a candidate risk score that incorporates current clinical, laboratory, and hemodynamic data. A registry-based observational study of adult heart transplant candidates (aged ≥18 years) from the US heart allocation system listed between January 1, 2019, and December 31, 2022, split by center into training (70%) and test (30%) datasets. Adult candidates were listed between January 1, 2019, and December 31, 2022. A US candidate risk score (US-CRS) model was developed by adding a predefined set of predictors to the current French Candidate Risk Score (French-CRS) model. Sensitivity analyses were performed, which included intra-aortic balloon pumps (IABP) and percutaneous ventricular assist devices (VAD) in the definition of short-term mechanical circulatory support (MCS) for the US-CRS. Performance of the US-CRS model, French-CRS model, and 6-status model in the test dataset was evaluated by time-dependent area under the receiver operating characteristic curve (AUC) for death without transplant within 6 weeks and overall survival concordance (c-index) with integrated AUC. A total of 16 905 adult heart transplant candidates were listed (mean [SD] age, 53 [13] years; 73% male; 58% White); 796 patients (4.7%) died without a transplant. The final US-CRS contained time-varying short-term MCS (ventricular assist-extracorporeal membrane oxygenation or temporary surgical VAD), the log of bilirubin, estimated glomerular filtration rate, the log of B-type natriuretic peptide, albumin, sodium, and durable left ventricular assist device. In the test dataset, the AUC for death within 6 weeks of listing for the US-CRS model was 0.79 (95% CI, 0.75-0.83), for the French-CRS model was 0.72 (95% CI, 0.67-0.76), and 6-status model was 0.68 (95% CI, 0.62-0.73). Overall c-index for the US-CRS model was 0.76 (95% CI, 0.73-0.80), for the French-CRS model was 0.69 (95% CI, 0.65-0.73), and 6-status model was 0.67 (95% CI, 0.63-0.71). Classifying IABP and percutaneous VAD as short-term MCS reduced the effect size by 54%. In this registry-based study of US heart transplant candidates, a continuous multivariable allocation score outperformed the 6-status system in rank ordering heart transplant candidates by medical urgency and may be useful for the medical urgency component of heart allocation.

Current Use and Impact of Pulmonary Artery Catheters on the Short-Term Outcomes in Patients With Cardiogenic Shock Treated With an Impella: Findings From the Japan Registry for Percutaneous Ventricular Assist Device (J-PVAD).

This study aimed to investigate the current use and impact of pulmonary artery catheters (PACs) in patients with cardiogenic shock (CS) who underwent Impella support. This was a prospective multicenter observational study between January 2020 and December 2021 that registered all patients with drug-refractory acute heart failure and in whom the placement of an Impella 2.5, CP, or 5.0 pump was attempted or successful in Japan. Cardiac ICUs in Japan. Between January 2020 and December 2021, a total of 3112 patients treated with an Impella were prospectively enrolled in the Japan registry for percutaneous ventricular assist device (J-PVAD). Among them, 2063 patients with CS were divided into two groups according to the PAC use. None. The primary endpoint was the 30-day mortality, and the secondary endpoints were hemolysis, acute kidney injury, sepsis, major bleeding unrelated to the Impella, and ventricular arrhythmias within 30 days. PACs were used in 1358 patients (65.8%) who underwent an Impella implantation. The use of venoarterial extracorporeal membrane oxygenation (VA-ECMO) was significantly higher in the patients with PACs than in those without. Factors associated with PAC use were the prevalence of hypertension, out-of-hospital cardiac arrest, New York Heart Association classification IV, the lesser prevalence of a heart rate less than 50, and the use of any catecholamine. The primary and secondary endpoints did not significantly differ according to the PAC use. Focusing on the patients with VA-ECMO use, the 30-day mortality and hemolysis were univariately lower in the patients with PACs. The J-PVAD findings indicated that PAC use did not have a significant impact on the short-term outcomes in CS patients undergoing Impella support. Further prospective studies are required to explore the clinical implications of PAC-guided intensive treatment strategies in these patients.

Methodological Study of Reliability Test of Percutaneous Ventricular Assist Device

Prior to clinical application, reliability of percutaneous ventricular assist devices(pVAD) requires to be tested systematically. Currently, there's a lack of dedicated reliability testing equipment and methodologies for pVAD. Considering the structural and functional aspects of percutaneous ventricular assist devices, this study conducts research on pVAD reliability test engineering. Test setups, clinical conditions, failure modes, effects analysis, and evaluation models have been investigated. A highly feasible methodological approach for percutaneous ventricular assist device reliability assessment has been formed. This study offers valuable insights into standardizing their reliability evaluation in clinical settings.

Impella device in fulminant myocarditis: Japanese Registry for Percutaneous Ventricular Assist Device (J-PVAD) registry analysis on outcomes and adverse events.

Given that fulminant myocarditis, characterized by unstable haemodynamics, is a significant clinical challenge and that traditional pharmacological treatments have limitations, evaluating alternatives such as the Impella device is a crucial focus of this study. Further, this study presents pioneering large-scale registry data on its use in managing fulminant myocarditis. Data from the Japanese Registry for Percutaneous Ventricular Assist Devices (J-PVAD) were analysed to assess Impella's role in managing fulminant myocarditis from February 2020 to December 2021. The primary outcome was 30-day mortality for those treated with Impella. Of the 269 patients treated with Impella, 107 used Impella standalone, and 162 used ECPELLA (Impella combined with extracorporeal membrane oxygenation). The average age was 54 years, with 42.8% females. Overall, 74.3% survived at 30 days. Specifically, the success rate was 68.5% for the ECPELLA group and 83.2% for the Impella standalone group. Cox regression highlighted that lower estimated glomerular filtration rate and pre-Impella systolic blood pressure increased adverse event risk, while Swan-Ganz catheterization use reduced it. Adverse events were noted in 48.7% of patients, such as bleeding (32.0%) and deteriorating renal function (8.6%). Impella's use in fulminant myocarditis demonstrates encouraging short-term outcomes, albeit with significant adverse events. These findings align with previous mechanical circulatory support studies, emphasizing caution regarding haemorrhagic issues. Further studies are essential to enhance patient selection and treatment approaches.

Outcomes of Veno-Arterial Extracorporeal Membrane Oxygenation With Percutaneous Left Ventricular Unloading in Fulminant Myocarditis.

Fulminant myocarditis requiring peripheral veno-arterial extracorporeal membrane oxygenation (VA-ECMO) has a high mortality rate. We investigated clinical outcomes of combined use of VA-ECMO and percutaneous left ventricular assist device (VAD) (Impella) for fulminant myocarditis in 104 consecutive patients enrolled in the Japan Registry for Percutaneous VAD (J-pVAD) between October 2017 and January 2020. Patients were followed until hospital discharge and predictors of survival were analyzed with a Cox proportional hazards model. The median support duration of combined use of VA-ECMO and Impella (ECMO/Impella) was 6 days, and the median left ventricular ejection fraction improved from 15% to 52% during support ( p < 0.0001). Overall, 66 patients (63%) survived to discharge. Multivariate analysis revealed ECMO/Impella support at a transplant center as an independent predictor of survival ( p = 0.0231). Patients treated at transplant centers had better 60 days survival rates when compared to nontransplant centers (83% vs. 55%, p = 0.005). However, baseline characteristics and treatment strategies differed between the two groups. This real-world national registry database suggested the difference in survival after ECMO/Impella support for fulminant myocarditis between transplant and nontransplant centers, which may indicate hospital variations regarding patient management, although further controlled studies are needed.

Abstract 14742: Clinical Predictors of Bleeding Complications Following Percutaneous Ventricular Assist Device Insertion: Insights From the J-PVAD (Japanese Registry for Percutaneous Ventricular Assist Device) Registry

Introduction: Bleeding complications are significant concerns in clinical use of percutaneous ventricular assist devices (PVAD). This study aimed to identify predictors of bleedings in PVAD use. Methods: We analyzed 3059 cases from the J-PVAD registry, a comprehensive national registry of PVAD use in Japan, excluding 53 cases without follow-up data. Patients were stratified based on whether they had acute coronary syndrome (ACS) on the onset or not, and incidence of bleeding was evaluated within each stratum, considering the clinically selected variables, including other mechanical circulatory support (MCS) use. Risk factors were explored through multivariate analyses. The primary outcome measure was any bleeding, while major bleeding was defined as a composite of cerebral bleeding, severe bleeding (defined as life-threatening, hospitalization-requiring, disability-causing, or congenital anomaly-inducing bleeding events), and blood transfusions. Results: The median follow-up period was 32 days. The cohort included 1459 patients with ACS and 1575 without ACS. The incidence of any bleeding did not differ significantly between the ACS and Non-ACS stratum (30-day incidence: 25.4% and 27.6%, P = 0.57, respectively). We observed the same trends for major bleeding. Most any bleeding or major bleeding occurred on the day of insertion of PVAD or within a few days. The groups with MCS had significantly more bleeding complications than those without MCS in each stratum (Figure). In a multivariate analysis using the Cox proportional hazards model, adding MCS on PVAD was the most potent predictor of any bleeding in both strata, with the effects of other variables being modest by comparison. Conclusions: Bleeding complications post-PVAD insertion are often severe and occur shortly after the procedure. Although the incidence of bleeding complications did not differ significantly according to the onset type, the MCS use strongly predicted bleeding complications.

Abstract 18152: Clinical Impact and Mechanism of De Novo Aortic Insufficiency During Percutaneous Ventricular Assist Device Support for Cardiogenic Shock

Introduction: Recently, percutaneous ventricular assist device (p-LVAD) has been widely applicable for cardiogenic shock. Clinically significant aortic insufficiency (AI) is contraindication for p-LVAD, nevertheless p-LVAD itself can cause de novo AI (dAI) during the support. However the detail of dAI during p-LVAD support was not fully investigated. The aim of this study was to evaluate the clinical impact of AI during p-LVAD support and also investigate the mechanism and risk factor of dAI. Methods: Seventy-seven consecutive patients who underwent p-LVAD support (average age 66.7 years, Impella CP/2.5 in 65 and 5.5/5.0 in 12 cases) from 2018 to 2022 were retrospectively evaluated. The average support periods was 8.0±6.9 days. dAI was defined as development of AI ≥ moderate during p-LVAD support. Aortic valve pathology was examined using autopsy specimens in eight patients. Results: Three patients had AI ≥ moderate before p-LVAD support and underwent surgical intervention (AVR in 2 and AV repair in 1) during p-LVAD support. dAI was observed in 8 patients (10.3%, moderate in 7 and severe in 1). Moderate dAI in four of these patients improved after cardiac recovery and weaning of p-LVAD support. However, in 3 other patients with dAI ≥ moderate developed hemodynamic instability and deceased due to heart failure. In only a patient, moderate dAI remained after p-LVAD weaning with stable hemodynamics. Progression of AI after p-LVAD removal was not observed in all patients. In-hospital mortality was higher in the patient with dAI (75.0 vs. 47.8%, p=0.14). Pathological evaluation revealed hemorrhagic change at LV side of aortic valve with hemosiderin-laden macrophages in 3 autopsy specimens, which suggested contact of p-LVAD catheter. The univariate analysis identified mild AI before p-LVAD support as independent risk factor for dAI (Odd ratio 5.5, 95%CI 0.074-0.45, p&lt;0.001). Conclusions: Our study demonstrated that de novo AI frequently occurred during p-LVAD support and had a negative impact on hemodynamics and prognosis. Interference with aortic valve by the p-LVAD catheter may cause and exacerbate AI, even in the cases with pre-existing mild AI. Surgical intervention is essential to improve hemodynamics for severe and permanent AI during p-LVAD support.

Abstract 14959: Impact of Timing of Venoarterial Extracorporeal Membrane Oxygenation Insertion (Before or After Impella) in Patients With Acute Myocardial Infarction With Cardiogenic Shock Using Impella: From J-PVAD Registry

Introduction: In patients with cardiogenic shock (CS), Impella, one type of percutaneous ventricular assist device with a catheter-type micro-axial heart pump, plus venoarterial extracorporeal membrane oxygenation (ECPELLA) has been reported to have a better short-term prognosis than venoarterial extracorporeal membrane oxygenation (VA-ECMO) alone, although it was associated with more complications. ECPELLA has often been used in current clinical practice instead of VA-ECMO alone. However, in many cases of acute myocardial infarction (AMI) with CS, there is controversy about whether Impella or VA-ECMO should be installed first. Hypothesis: What are the factors associated with Impella use first? Does the timing of VA-ECMO insertion affect prognosis and major adverse events (MAEs) such as hemolysis, hemorrhage/hematoma, peripheral ischemia, stroke, and thrombosis? This study aims to clarify the factors of Impella use first and the prognostic impact of the timing of VA-ECMO insertion (before or after Impella). Methods: The Japanese registry for Percutaneous Ventricular Assist Device (J-PVAD) has registered all consecutive Japanese patients treated with Impella between February 2020 and December 2021. In the current study, we evaluated 523 patients with AMI with CS and investigated the factors of Impella use before VA-ECMO and the impact of the timing of VA-ECMO insertion on 30 days mortality and MAEs. Results: Out of the total number of patients, 155 (30%) received Impella prior to VA-ECMO, while 367 (70%) received Impella following VA-ECMO. The factors of Impella use before VA-ECMO were the absence of out-of-hospital and in-hospital cardiac arrest. The cumulative 30-day incidence of all-cause death was 46.1% in patients with Impella use before VA-ECMO and 53.5% in those with Impella use after VA-ECMO (Log-rank P=0.13). There was no excess risk of Impella use before VA-ECMO relative to Impella use after VA-ECMO (adjusted HR, 0.95; 95%CI, 0.47-1.94; P=0.90). There were no significant differences in the incidence of MAEs between the two groups. Conclusions: The prognosis for patients with AMI complicated by CS requiring ECPELLA remained poor, but the timing of VA-ECMO insertion did not affect the prognosis.

Safety and Effectiveness of an Anti-Xa-based Unfractionated Heparin Protocol for Impella Percutaneous Ventricular Assist Devices.

Background: Impella devices are used for mechanical circulatory support in patients with cardiogenic shock or those undergoing high-risk percutaneous coronary intervention (PCI). Anticoagulation protocols in this population are not well established and are complicated by concomitant use of purge solutions containing unfractionated heparin (UFH) and intravenous UFH continuous infusion (CI) for systemic anticoagulation. Objectives: To evaluate thrombotic and bleeding complications when using a novel UFH protocol with a reduced initial UFH CI dose of 6 units/kg/hour targeting an anti-Xa goal of 0.3 to 0.5 units/mL in patients receiving Impella support. Methods: This single-center, retrospective study included 41 patients on Impella support who received an UFH purge solution and/or an IV UFH infusion. The primary outcome was overall composite bleeding. Secondary outcomes included thrombotic events and systemic UFH exposure. An exploratory analysis was performed to identify risk factors for bleeding. Results: Anti-Xa values were in therapeutic range 46% of the time while on support (interquartile range 16.6%-75%), with a median IV UFH dose of 6 units/kg/hour. The overall bleeding rate was 29.2%, with 6 minor bleeds and 2 major bleeds with no fatal bleeding or intracranial hemorrhage. Rate of overall thrombosis was 4.9%, including 1 ischemic stroke and 1 occurrence of limb ischemia. Conclusion: Use of a modified UFH protocol to target an anti-Xa goal of 0.3 to 0.5 units/mL resulted in bleeding and thrombotic event rates similar to previous literature. This protocol utilizing an initial rate of 6 units/kg/hour may be a useful approach to achieve therapeutic anticoagulation while accounting for UFH exposure from the purge solution and minimizing need for frequent calculations.

Abstract 15300: Short-Term Outcomes in Different Revascularization for Acute Coronary Syndrome With Cardiogenic Shock Supported by Impella -Report From Japanese Registry for Percutaneous Ventricular Assist Device (J-PVAD Registry)

Introduction and Hypothesis: Percutaneous coronary intervention (PCI) has tended to be selected for the treatment of acute coronary syndrome with cardiogenic shock because of its ability of earlier and less-invasive therapy, though coronary artery bypass grafting (CABG) can perform complete revascularization. We hypothesized that Impella® support has the potential to make surgical treatment much safer because Impella® can improve hemodynamic state and could have the possibility to mitigate myocardial ischemia by unloading the left ventricle. Methods: The aim of study is to investigate if surgical revascularization is safe and effective treatment by comparing short-term outcome with different revascularization including PCI, CABG, and hybrid therapy (PCI followed by CABG). Of 1102 cardiogenic shock cases with Impella (994 cases in PCI, 48 cases in CABG, and 63 cases in Hybrid therapy) between February 2020 and December 2021 enrolled in the J-PVAD registry, short-term outcomes were compared between 62 propensity-matched cases between PCI (n=31) and CABG (n=31), as well as 68 matched cases between PCI (n=34) and hybrid therapy (n=34). Results: There was no difference in all-cause mortality between the PCI and CABG group as well as PCI and hybrid therapy group. The PCI group had a greater number of NYHA class≦2 at discharge than the CABG group (17 (54.8%) in the PCI group vs 10 (32.2%) in the CABG group, p=0.012). There was no difference in the number of NYHA class≦2 at discharge between the PCI and hybrid therapy group (18 (52.9%) in the PCI group vs 15 (44.1%) in the hybrid therapy group, p=0.12). Conclusions: CABG and hybrid therapy showed acceptable short-term outcome compared to PCI.

Abstract 14532: The Off-Hour Effect on Clinical Outcomes of ST-Segment Elevation Myocardial Infarction Complicated by Cardiogenic Shock Patients Treated With Impella: Insight From Japanese Registry for Percutaneous Ventricular Assist Device (J-PVAD)

Introduction: The off-hours effect is a contentious issue in that patients admitted on weekends or nighttime have worse outcomes than on weekday daytime. The off-hours effect in patients with ST-segment elevation myocardial infarction complicated by cardiogenic shock (STEMI-CS) treated with Impella has not been fully evaluated. Hypothesis: The off-hours admission is associated with longer door-to-unload (DTU) time, door-to-balloon (DTB) time, and higher mortality in this population. Methods: We used the Japanese large-scale registry data for Percutaneous Ventricular Assist Device (J-PVAD), which registered all consecutive patients treated with Impella from December 2019 to July 2022. We compared the effects of on-hours and off-hours admissions on DTU time, DTB time, and 30-day mortality. We defined “on-hours” as between 8:00 and 19:59 on weekdays and the other time as “off-hours”. A multiple linear regression model was used to reveal the independent factors of prolonged DTU and DTB times. The Cox proportional hazards model was applied to calculate adjusted hazard ratios [aHR] for 30-day mortality, controlling for conventional cardiac risk factors. Results: Of 2,453 patients, 775 (32%) (mean age 68 years, 628 (81%) male) STEMI-CS patients treated with Impella were included. Among them, 401 (39%) were admitted during off-hours. We observed 155 deaths (49%) among patients admitted off-hours and 134 deaths (36%) among patients admitted on-hours during the follow-up period (median: 23 days). The DTU and DTB times were significantly longer in patients admitted off-hours than in patients admitted on-hours (91 (IQR 74-164) vs. 74 (62-151) minutes, p&amp;lt;0.001; 104 (77-134) vs. 89 (61-122), p&amp;lt;0.001, respectively). The linear regression model showed that the off-hours admission was associated with longer DTU time (β=14.3 minutes, 95% CI 4.8-23.8, p=0.003) and DTB time (15.4, 5.0-25.7, p=0.004). The Cox proportional hazards model showed that off-hours admission was associated with a higher risk of 30-day mortality than on-hours admission (aHR=1.42, 95% CI: 1.03-1.96, p=0.03). Conclusion: Our findings implied that the off-hours effect existed in DTU time, DTB time, and 30-day mortality among STEMI-CS patients treated with Impella.

Access Site–Stratified Analysis of the Incidence, Predictors, and Outcomes of Impella-Supported Patients With Cardiogenic Shock

This study aimed to evaluate the incidence, predictors, and outcomes of Impella-assisted patients with cardiogenic shock, stratified by the access site-transaxillary (TX) or trans-subclavian (TS) versus the conventional transfemoral (TF) approach. For this study, we analyzed the cases entered into the Japanese Percutaneous Ventricular Assist Device registry between February 2020 and December 2021. A multivariable logistic regression analysis was conducted to calculate the adjusted odds ratio (aOR) and 95% confidence intervals (CIs) to identify the predictors of the TX/TS approach, with reference to those who received the conventional TF approach. A log-rank test was performed to compare the 30-day mortality between the 2 approaches. A total of 2,564 cases of Impella were included in the study, of which 167 (6.5%) were accessed by way of the TX/TS approach. TX/TS approach cases were younger and had a higher percentage of concomitant use of extracorporeal membrane oxygenation or an intra-aortic balloon pump. The predictors of the TX/TS approach included a presentation with the acute coronary syndrome (aOR 0.32, 95% CI 0.16 to 0.63, p <0.001), cardiac arrest (aOR 0.10, 95% CI 0.02 to 0.36, p=0.003), cardiogenic shock (aOR 0.51, 95% CI 0.33 to 0.79, p=0.002), and inotropic use (aOR 1.88, 95% CI 1.08 to 3.49, p=0.033). The 30-day mortality was comparable between TX/TS and TF approaches (29.3% vs 29.6%, respectively; log-rank, p=0.64). Our analysis revealed that approximately 6% of the Impella-assisted patients with cardiogenic shock received the TX/TS approach as their first access site. These results suggest that the TX/TS approach may be a viable alternative to the TF approach in certain patients requiring Impella support.

Sex-Related Differences in Short-Term Prognosis in Patients with Acute Myocardial Infarction-Related Cardiogenic Shock Receiving Impella Support in Japan: From the J-PVAD Registry.

Background and Objectives: Sex-specific outcome in patients with acute myocardial infarction-related cardiogenic shock (AMI-CS) receiving temporary mechanical circulatory support remains controversial. Materials and Methods: Patients with AMI-CS who received Impella support were prospectively enrolled in the Japanese registry for Percutaneous Ventricular Assist Device. Patients enrolled between January 2021 and December 2022 were considered to be eligible. Patients with out-of-hospital cardiac arrest and those without revascularization were excluded. The sex disparity in the 30-day survival after the initiation of Impella support was evaluated. Results: A total of 924 patients (median age 73 years; 21% female) were included. Female patients were older and had a smaller physiques than male patients (p < 0.05 for both). Female sex was significantly associated with a higher 30-day mortality after adjustment for four other potential confounders with a hazard ratio of 1.365 (95% confidence interval 1.026-1.816, p = 0.0324). In the female cohort, patients who received Impella prior to revascularization (N = 138) had a greater survival rate compared to those who received Impella after revascularization (68.1% versus 44.8%, p = 0.0015). Conclusions: Among the patients with AMI-CS who received Impella support and underwent revascularization, female sex was independently associated with a lower 30-day survival. For female patients, early initiation of Impella support prior to revascularization may improve their clinical outcomes.

Short-Term Outcomes of Impella Support in Japanese Patients With Cardiogenic Shock Due to Acute Myocardial Infarction - Japanese Registry for Percutaneous Ventricular Assist Device (J-PVAD).

The Impella®percutaneous left ventricular assist device has been available in Japan since 2017. This is the first large-scale registry study to analyze the efficacy and safety of Impella in Japanese patients with acute myocardial infarction with cardiogenic shock (AMICS).Methods and Results: The Japanese registry for Percutaneous Ventricular Assist Device (J-PVAD) has registered all consecutive Japanese patients treated with Impella. We extracted data for 593 AMICS patients from J-PVAD and analyzed 30-day survival and safety profiles. Overall 30-day survival was 63.1%. The 30-day survival of the Impella alone and Impella plus venoarterial extracorporeal membrane oxygenation (ECPELLA) groups was 80.9% and 45.7%, respectively. The Impella alone group was older and had a lower rate of cardiac arrest, milder consciousness disturbance, less inotrope use, lower serum lactate concentrations, higher B-type natriuretic peptide concentrations, and higher left ventricular ejection fraction (LVEF) than the ECPELLA group. Cox regression analysis revealed that older age and comorbid renal disturbance were common risk factors affecting 30-day mortality in both groups. Major adverse events were hemolysis (10.8%), hemorrhage/hematoma (7.6%), peripheral ischemia (4.4%), stroke (1.3%), and thrombosis (0.7%). LVEF improved in both groups during support. AMICS treatment with Impella showed favorable 30-day survival and safety profiles. The survival rate of patients treated with Impella alone was particularly high. Further studies are needed to improve outcomes of patients with ECPELLA support.

TCT-91 Short-Term Outcomes of Impella in Patients With Cardiogenic Shock Due to Acute Myocardial Infarction: Japanese Registry for Percutaneous Ventricular Assist Device (J-PVAD)

TCT-91 Short-Term Outcomes of Impella in Patients With Cardiogenic Shock Due to Acute Myocardial Infarction: Japanese Registry for Percutaneous Ventricular Assist Device (J-PVAD)

Diffusion of Percutaneous Ventricular Assist Devices in US Markets.

Percutaneous 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. Using 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. A 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. Although 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.

Rising Use of Percutaneous Ventricular Assist Devices: What Can Be Learned From the Data?

Rising Use of Percutaneous Ventricular Assist Devices: What Can Be Learned From the Data?

P36: Percutaneous Right Ventricular Assist Device (RVAD) as an Alternative to Continuous Renal Replacement Therapy (CRRT) in Postcardiotomy Renal Failure

P36: Percutaneous Right Ventricular Assist Device (RVAD) as an Alternative to Continuous Renal Replacement Therapy (CRRT) in Postcardiotomy Renal Failure

CARC2: The Impella 5.5 and Impella 5.0: Emerging Role of Percutaneous Ventricular Assist Devices in the Management of Cardiogenic Shock

CARC2: The Impella 5.5 and Impella 5.0: Emerging Role of Percutaneous Ventricular Assist Devices in the Management of Cardiogenic Shock