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Background: Prior studies have found that patients with chronic kidney disease (CKD) have worse outcomes following percutaneous coronary intervention (PCI). There are no data about patients with advanced CKD undergoing Impella-supported high-risk PCI. We, therefore, aimed to evaluate angiographic characteristics and clinical outcomes in patients with CKD who received Impella-supported high-risk PCI as part of the catheter-based ventricular assist device PROTECT III study (A Prospective, Multi-Center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump [IABP] in Patients Undergoing Non Emergent High Risk PCI)., Methods: Patients enrolled in the PROTECT III study were analyzed according to their baseline estimated glomerular filtration rate (eGFR). The primary outcome was 90-day major adverse cardiovascular and cerebrovascular events (the composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization)., Results: Of 1237 enrolled patients, 1052 patients with complete eGFR baseline assessment were evaluated: 586 with eGFR ≥60 mL/min per 1.73 m 2 , 190 with eGFR ≥45 to <60, 105 with eGFR ≥30 to <45, and 171 with eGFR <30 or on dialysis. Patients with lower eGFR (all groups with eGFR <60) were more frequently females and had a higher prevalence of hypertension, diabetes, anemia, and peripheral artery disease. The baseline Synergy Between PCI With Taxus and Cardiac Surgery score was similar between groups (28.2±12.6 for all groups). Patients with lower eGFR were more likely to have severe coronary calcifications and higher usage of atherectomy. There were no differences in individual PCI-related coronary complications between groups, but the rates of overall PCI complications were less frequent among patients with lower eGFR. Major adverse cardiovascular and cerebrovascular events at 90 days and 1-year mortality were significantly higher among patients with eGFR <30 mL/min per 1.73 m 2 or on dialysis., Conclusions: Patients with advanced CKD undergoing Impella-assisted high-risk PCI tend to have higher baseline comorbidities, severe coronary calcification, and higher atherectomy usage, yet CKD was not associated with a higher rate of immediate PCI-related complications. However, 90-day major adverse cardiovascular and cerebrovascular events and 1-year mortality were significantly higher among patients with eGFR<30 mL/min per 1.73 m 2 or on dialysis. Future studies of strategies to improve intermediate and long-term outcomes of these high-risk patients are warranted., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04136392., Competing Interests: Dr Bharadwaj reports consulting and speaker fees from Abiomed, Shockwave Medical, and Cardiovascular Systems, Inc. Dr Batchelor reports consulting for Abbott, Medtronic, and Boston Scientific. Dr Grines reports participation on the advisory boards for Philips and Abiomed. Dr Baron reports receiving institutional research support from Boston Scientific Corporation, Acarix, and Abiomed; speaker fees from Medtronic, Edwards Lifesciences, Shockwave, and Zoll Medical; and consulting fees/advisory board membership from Medtronic, Boston Scientific Corporation, Zoll Medical, and Abiomed. Dr Redfors reports consultant fees from Pfizer and Boehringer Ingelheim. Dr Lansky received speaker fees from Abiomed. M.B. Basir has been a consultant/speaker for Abiomed, Boston Scientific, Chiesi, Saranas, and Zoll. Dr O’Neill reports grant/research support from St. Jude Medical, Edwards Life Sciences, and Biomed; consulting fees/honoraria from Medtronic and Abiomed; and major stock shareholder/equity in Synecor, Accumed, Neovasc, Tendyne, and Mitral Align. The other authors report no conflicts.

Background: There is limited real-world data highlighting recent temporal in-hospital morbidity and mortality trends for cases of acute myocardial infarction complicated by cardiogenic shock. The role of mechanical circulatory support within this patient population remains unclear., Methods: The US National Inpatient Sample database was sampled from 2011 to 2018 identifying 206,396 hospitalizations with a primary admission diagnosis of ST- or Non-ST elevation myocardial infarction complicated by cardiogenic shock. The primary outcomes included trends of all-cause in-hospital mortality, mechanical circulatory support use, and sex-specific trends for acute myocardial infarction complicated by cardiogenic shock (AMI-CS) over the study period., Results: The annual number of AMI-CS hospitalizations increased from 22,851 in 2011 to 30,015 in 2018 and in-hospital mortality trends remained similar (42.9 % to 43.7 %, ptrend < 0.001). The proportion of patients receiving any temporary MCS device decreased (46.4 % to 44.4 %). The use of intra-aortic balloon pump (IABP) decreased (44.9 % to 32.9 %) and the use of any other non-IABP MCS device increased (2.5 % to 15.6 %), ptrend<0.001. Sex-specific mortality indicate female in-hospital mortality remained similar (50.3 % to 51 %, ptrend<0.001), but higher than male in-hospital mortality, which increased non-significantly (38.8 % to 40.2 %, ptrend = 0.372)., Conclusions: From 2011 to 2018, hospitalizations for AMI-CS patients have increased in number. However, there has been no recent appreciable change in AMI-CS mortality despite a changing treatment landscape with decreasing use of IABPs and increasing use of non-IABP MCS devices. Further research is necessary to examine the appropriate use of MCS devices within this population., Competing Interests: Declaration of competing interest None. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The authors have no other financial or personal relationships with other people or organizations to disclose., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Evidence on the comparative outcomes following percutaneous microaxial ventricular assist devices (pVAD) versus intra-aortic balloon pump for nonacute myocardial infarction cardiogenic shock is limited., Methods and Results: We included 704 and 2140 Medicare fee-for-service beneficiaries aged 65 to 99 years treated with pVAD and intra-aortic balloon pump, respectively, for nonacute myocardial infarction cardiogenic shock from 2016 to 2020. Patients treated using pVAD compared with those treated using intra-aortic balloon pump were more likely to be concurrently treated with mechanical ventilation, renal replacement therapy, and blood transfusions. We computed propensity scores for undergoing pVAD using patient- and hospital-level factors and performed a matching weight analysis. The use of pVAD was associated with higher 30-day mortality (adjusted odds ratio, 1.92 [95% CI, 1.59-2.33]) but not associated with in-hospital bleeding (adjusted odds ratio, 1.00 [95% CI, 0.81-1.24]), stroke (adjusted odds ratio, 0.91 [95% CI, 0.56-1.47]), sepsis (OR, 0.91 [95% CI, 0.64-1.28]), and length of hospital stay (adjusted mean difference, +0.4 days [95% CI, -1.4 to +2.3]). A quasi-experimental instrumental variable analysis using the cross-sectional institutional practice preferences showed similar patterns, though not statistically significant (adjusted odds ratio, 1.38; 95% CI, 0.28-6.89)., Conclusions: Our investigation using the national sample of Medicare beneficiaries showed that the use of pVAD compared with intra-aortic balloon pump was associated with higher mortality in patients with nonacute myocardial infarction cardiogenic shock. Providers should be cautious about the use of pVAD for nonacute myocardial infarction cardiogenic shock, while adequately powered high-quality randomized controlled trials are warranted to determine the clinical effects of pVAD.

Background: Surgical revascularization is associated with improved ventricular function and clinical outcomes among patients with ischemic cardiomyopathy. There are less extensive data on changes in ventricular function among patients with ischemic cardiomyopathy undergoing percutaneous coronary intervention (PCI). Accordingly, we sought to assess the extent and predictors of change in left ventricular ejection fraction (ΔLVEF) among patients undergoing hemodynamically-supported PCI., Methods: We assessed ΔLVEF following hemodynamically-supported PCI (with Impella or intra-aortic balloon counterpulsation) among patients enrolled in the PROTECT II trial and cVAD registry. The ΔLVEF was compared among patients with paired echocardiography at baseline and at least 30 days of follow-up. Independent correlates of ΔLVEF (modeled continuously and with an absolute ΔLVEF≥5%) were assessed using multivariable models., Results: Among the 689 patients with paired echocardiographic data included in the analysis, the mean LVEF improved from 24.8 ± 9.9% to 31.4 ± 13.3% after PCI, for a net increase of 6.5 ± 10.8% (p < .001). A total of 395 (57%) patients had ΔLVEF ≥ 5% following hemodynamically-supported PCI. The number of vessels treated was associated with ΔLVEF (ΔLVEF 5.5% with 1 vessel, 6.6% with 2 vessels, and 8.3% with 3 vessels, p for trend = .046). A lower baseline LVEF, absence of a history of congestive heart failure or aldosterone receptor antagonist use, and a greater number of vessels treated were independent correlates of LVEF improvement., Conclusions: Among patients with severe left ventricular systolic dysfunction and paired echocardiographic assessments, an improvement in LVEF was observed following hemodynamically-supported PCI., (© 2019 Wiley Periodicals, Inc.)

Background: The utilization of mechanical circulatory support (MCS) for percutaneous coronary intervention (PCI) using percutaneous ventricular assist device (PVAD) or intra-aortic balloon pump (IABP) has been increasing. We sought to evaluate the outcome of coronary intervention using PVAD compared with IABP in noncardiogenic shock and nonacute myocardial infarction patients., Method: Using the National Inpatient Sampling (NIS) database from 2005 to 2014, we identified patients who underwent PCI using ICD 9 codes. Patients with cardiogenic shock, acute coronary syndrome, or acute myocardial infarction were excluded. Patient was stratified based on the MCS used, either to PVAD or IABP. Univariate and multivariate logistic regression were performed to study PCI outcome using PVAD compared with IABP., Results: Out of 21,848 patients who underwent PCI requiring MCS, 17,270 (79.0%) patients received IABP and 4,578 (21%) patients received PVAD. PVAD patients were older (69 vs. 67, p < .001), were less likely to be women (23.3% vs. 33.3%, p < .001), and had higher rates of hypertension, diabetes, hyperlipidemia prior PCI, prior coronary artery bypass graft surgery, anemia, chronic lung disease, liver disease, renal failure, and peripheral vascular disease compared with IABP group (p ≤ .007). Using Multivariate logistic regression, PVAD patients had lower in-hospital mortality (6.1% vs. 8.8%, adjusted odds ratio [aOR] 0.62; 95% CI 0.51, 0.77, p < .001), vascular complications (4.3% vs. 7.5%, aOR 0.78; 95% CI 0.62, 0.99, p = .046), cardiac complications (5.6% vs. 14.5%, aOR 0.29; 95% CI 0.24, 0.36, p < .001), and respiratory complications (3.8% vs. 9.8%, aOR 0.37; 95% CI 0.28, 0.48, p < .001) compared with patients who received IABP., Conclusion: Despite higher comorbidities, nonemergent PCI procedures using PVAD were associated with lower mortality compared with IABP., (© 2019 Wiley Periodicals, Inc.)

Background: Pulseless ventricular tachycardia/ventricular fibrillation (VT/VF) is the initial rhythm in a third of in-hospital cardiac arrest patients. Mechanical circulatory support (MCS) device use remains poorly understood in this population., Methods: We conducted an observational analysis of temporal trends in the utilization of MCS in VT/VF IHCA between January 2008 and December 2014 utilizing the Nationwide Inpatient Sample (NIS) database. Using multivariable analysis, we assessed factors associated with MCS use and survival to discharge., Results: Among 151,628 hospitalizations with VT/VF IHCA, 14,981 (9.9%) received MCS. Intra-aortic balloon pump (IABP) was the most commonly used MCS (9.1%). From 2008 to 2014, there was significant increase in the utilization of MCS (8.7-11%; p trend  < 0.0001). On multivariable analysis, there was 12-fold increase and three-fold increase in the utilization of PVAD and ECMO respectively; however, there was no significant change in the use of IABP. Over the seven-year sample period, there was significant increase in the overall survival to hospital discharge (35.4-43.5%; p trend  < 0.0001). Survival to hospital discharge increased in both MCS and non-MCS groups., Conclusion: There was significant increase in utilization of MCS after VT/VF IHCA during the study period. IABP was the most commonly utilized MCS. The survival to hospital discharge increased in the overall study population including both MCS and non-MCS groups. Future studies are needed to identify patient population most likely to benefit from the use of MCS after VT/VF IHCA., (© 2019 Wiley Periodicals, Inc.)

Background: Limited knowledge exists on inter-hospital variation in the utilization of short-term, nondurable mechanical circulatory support (MCS) for myocardial infarction (MI) complicated by cardiogenic shock (CS)., Methods and Results: Hospitalizations for MI with CS in 2014 in a nationally representative all-payer database were included. The proportion of hospitalizations for MI with CS using MCS (MCS ratio) and in-hospital mortality were evaluated. Hospital characteristics and outcomes were compared across quartiles of MCS usage. Of 1813 hospitals evaluated, 1440 (79.4%) performed ≥10 percutaneous coronary interventions annually. Of these, 1064 (73.9%) had at least one code for MCS. Forty-one percent of hospitals did not use MCS. The median (interquartile range) proportion of MCS use among admissions for MI with CS was 33.3% (0.0%-50.0%). High MCS utilizing hospitals were larger ( P<0.001). Eighty-five percent (2808/3301) of MCS use was intra-aortic balloon pump. There was significant variation in receipt of MCS at different hospitals (median odds ratio of receiving MCS at 2 random hospitals: 1.58; 95% CI, 1.45-1.70). Adjusted in-hospital mortality was not different across quartiles of MCS use (Q4 versus Q1; odds ratio, 0.95; 95% CI, 0.77-1.16; P=0.58)., Conclusions: Wide variation exists in hospital use of MCS for MI with CS, unexplained by patient characteristics. The predominant form of MCS use is intra-aortic balloon pump. Risk-adjusted mortality rates were not different between higher and lower MCS-utilizing hospitals.

Aims: Despite rising rates of cardiogenic shock (CS), data on trends and in-hospital outcomes of short-term non-durable mechanical circulatory support (MCS) are limited. Thus, we aimed to identify recent national trends in MCS utilisation in the USA, patient-level predictors of MCS use, and in-hospital outcomes in CS inclusive of extracorporeal membrane oxygenation (ECMO)., Methods and Results: Hospitalisations of US adults with a discharge diagnosis of CS, from January 2004 to December 2014, in the National Inpatient Sample were included. Rates of MCS were stratified by device type and clinical presentation. Outcomes included in-hospital mortality, hospitalisation costs, and number of procedures. A total of 183,516 hospitalisations with CS (47,636 [25.9%] involving MCS) were included. MCS recipients were younger, less frequently female, received more procedures, had higher costs, and more frequently presented with MI (MCS vs. non-MCS: 71.6% vs. 42.9%; p<0.0001). Growth in CS hospitalisations (214.4%) outpaced annual MCS use (160.0%), with relative declines in intra-aortic balloon pump use starting in 2008. Right heart catheterisation rates for both groups remained low (MCS vs. non-MCS: 5.9% vs. 3.3%; p<0.0001). In-hospital mortality declined but remained high in both groups (MCS vs. non-MCS [2014]: 32.7% vs. 41.5%; p<0.0001)., Conclusions: In-hospital mortality for CS has declined but remains high. Rates of CS have outpaced MCS utilisation which remains uncommon in non-MI hospitalisations with shock. MCS is associated with utilisation of other procedures during hospitalisation.

Background: Recent trends on outcomes in cardiogenic shock (CS) complicating acute myocardial infarction (AMI) suggest improvements in early survival. However, with the ever-changing landscape in management of CS, we sought to identify age-based trends in these outcomes and mechanical circulatory support (MCS) use among patients with both AMI and non-AMI associated shock., Methods: We queried the 2005-2014 Nationwide Inpatient Sample databases to identify patients with a diagnosis of cardiogenic shock. Trends in the incidence of hospital-mortality, and use of MCS such as intra-aortic balloon pump (IABP), Impella/TandemHeart (IMP), and extra corporeal membrane oxygenation (ECMO) were analyzed within the overall population and among different age-categories (50 and under, 51-65, 66-80 and 81-99 years). We also made comparisons between patient groups admitted with CS complicating AMI and those with non-AMI associated CS., Results: We studied 144,254 cases of CS, of which 55.4% cases were associated with an AMI. Between 2005 and 2014, an overall decline in IABP use (29.8-17.7%; ptrend < 0.01), and an uptrend in IMP use (0.1-2.6%; ptrend < 0.01), ECMO use (0.3-1.8%; ptrend < 0.01) and in-hospital mortality (44.1-52.5% AMI related, 49.6-53.5% non-AMI related; ptrend < 0.01) was seen. Patients aged 81-99 years had the lowest rate of MCS use (14.8%), whereas those aged 51-65 years had highest rate of MCS use (32.3%). Multivariable analysis revealed that patients aged 51-65 years (aOR 1.46, 95% CI 1.40-1.52; p<0.001), 66-80 years (aOR 2.51, 95% CI 2.39-2.63; p<0.01) and 81-99 years (aOR 5.04, 95% CI 4.78-5.32; p<0.01) had significantly higher hospital mortality compared to patients aged ≤ 50 years. Patients admitted with CS complicating AMI were older and had more comorbidities, but lower hospital mortality (45.0 vs. 48.2%; p < 0.001) when compared to non-AMI related CS. We also noted that the proportion of patients admitted with CS complicating AMI significantly decreased from 2005 to 2014 (65.3-45.6%; ptrend < 0.01) whereas those admitted without an associated AMI increased., Conclusions: IABP use has declined whereas IMP and ECMO use has increased over time among CS admissions. Older age was associated with an incrementally higher independent risk for hospital mortality. Recent trends indicate an increase in both proportion of patients admitted with CS without associated AMI and in-hospital mortality across all CS admissions irrespective of AMI status.

Background: Transcatheter aortic valve replacement (TAVR) with the balloon-expandable Sapien transcatheter heart valve improves survival compared to standard therapy in patients with severe aortic stenosis (AS) and is noninferior to surgical aortic valve replacement (AVR) in patients at high operative risk. Nonetheless, a significant proportion of patients may require pre-emptive or emergent support with cardiopulmonary bypass (CPB) and/or intra-aortic balloon pump (IABP) during TAVR due to pre-existing comorbid conditions or as a result of procedural complications., Objectives: We hypothesized that patients who required CPB or IABP would have increased periprocedural complications and reduced long-term survival. In addition, we sought to determine whether preprocedural variables could predict the need for CPB and IABP., Methods: The study population included 2,525 patients in the PARTNER Trial (Cohort A and B) and the continuing access registry (CAR). Patients that received CPB or IABP were compared to patients that did not receive either, and then further divided into those that received support pre-TAVR and those that were placed on support emergently., Results: One-hundred sixty-three patients (6.5%) were placed on CPB and/or IABP. The use of CPB or IABP was associated with higher 1 year mortality (49.1% vs. 21.6%, P < 0.001). In multivariable analysis, utilization of CPB or IABP was an independent predictor of 30 day (HR 6.95) and 1-year (HR 2.56) mortality. Although mortality was highest in emergent cases, mortality was also greater in planned CPB and IABP cases compared with non-CPB/IABP cases (53.3% and 40.3% vs. 21.6%, P < 0.001)., Conclusions: These findings indicate that CPB and IABP use in TAVR portends a poor prognosis and its utilization, particularly in the setting of pre-emptive use, needs reconsideration., (© 2015 Wiley Periodicals, Inc.)

Background: Cardiogenic shock (CS) is associated with significant morbidity, and mortality rates approach 40% to 60%. Treatment for CS requires an aggressive, sophisticated, complex, goal-oriented, therapeutic regimen focused on early revascularization and adjunctive supportive therapies, suggesting that hospitals with greater CS volume may provide better care. The association between CS hospital volume and inpatient mortality for CS is unclear., Methods and Results: We used the Nationwide Inpatient Sample to examine 533 179 weighted patient discharges from 2675 hospitals with CS from 2004 to 2011 and divided them into quartiles of mean annual hospital CS case volume. The primary outcome was in-hospital mortality. Multivariate adjustments were performed to account for severity of illness, relevant comorbidities, hospital characteristics, and differences in treatment. Compared with the highest volume quartile, the adjusted odds ratio for inpatient mortality for persons admitted to hospitals in the lowest-volume quartile (≤27 weighted cases per year) was 1.27 (95% CI 1.15 to 1.40), whereas for admission to hospitals in the low-volume and medium-volume quartiles, the odds ratios were 1.20 (95% CI 1.08 to 1.32) and 1.12 (95% CI 1.01 to 1.24), respectively. Similarly, improved survival was observed across quartiles, with an adjusted inpatient mortality incidence of 41.97% (95% CI 40.87 to 43.08) for hospitals with the lowest volume of CS cases and a drop to 37.01% (95% CI 35.11 to 38.96) for hospitals with the highest volume of CS cases. Analysis of treatments offered between hospital quartiles revealed that the centers with volumes in the highest quartile demonstrated significantly higher numbers of patients undergoing coronary artery bypass grafting, percutaneous coronary intervention, or intra-aortic balloon pump counterpulsation. A similar relationship was demonstrated with the use of mechanical circulatory support (ventricular assist devices and extracorporeal membrane oxygenation), for which there was significantly higher use in the higher volume quartiles., Conclusions: We demonstrated an association between lower CS case volume and higher mortality. There is more frequent use of both standard supportive and revascularization techniques at the higher volume centers. Future directions may include examining whether early stabilization and transfer improve outcomes of patients with CS who are admitted to lower volume centers., (© 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

The aim of this study was to review and describe indications for intraaortic balloon counterpulsation (IABP) use and identify the impact these have on outcomes at an Australian cardiothoracic tertiary referral hospital. A secondary aim was comparison of the Australian practice with a large multinational IABP data registry. Patient demographics, IABP indication, IABP complication rate and mortality in 662 patients treated with IABP at The Prince Charles Hospital (TPCH), Brisbane, between January 1994 and December 2004 inclusive were compared with The Benchmark Counterpulsation Outcomes Registry. Data were collected between 1994 and 2000 by retrospective patient record review and prospectively using the Benchmark database from 2001 to 2004. Statistical analysis was undertaken using SAS (v8.2) software. The mean age of patients managed with IABP at TPCH (71.6% male) was 63.4 years (SD 12.4). In-hospital mortality rate was 22% and the complication rate was 10.3%. TPCH indications for IABP were: weaning from cardiopulmonary bypass (34.2%); cardiogenic shock (24.4%); preoperative support (13%); catheter laboratory support (10.6%); refractory ventricular failure (7.3%); ischaemia related to intractable ventricular arrhythmias (4.5%); unstable refractory angina (4%); mechanical complications due to acute myocardial infarction (1.2%) and other (0.4%) (0.4% not reported). In comparison to Benchmark, IABP at TPCH demonstrated a prejudice toward intraoperative use (34.2% versus 16.6%; P < or = 0.0001) and an aversion to catheter laboratory support (10.6% versus 19%; P < or = 0.0001). TPCH and Benchmark IABP outcomes demonstrated comparable mortality (22% versus 20.8%; P = ns) but increased TPCH complications (10.3% vs. 6.2%; P < or = 0.0001) owing to a 2% difference in observed insertion site bleeding.

Aims: To examine differences in patient characteristics and outcomes in 19636 patients enrolled in the USA and 3027 patients enrolled in other countries undergoing intra-aortic balloon pump (IABP) counterpulsation., Methods and Results: Indications for IABP use; a larger percentage of US patients were identified as 'early support and stabilization for angiography or angioplasty' (21.1% US vs 11.8% non-US), and 'pre-operative support for high-risk CABG' (15.9% vs 6.6%). A smaller percentage of US patients vs non-US patients were identified as 'weaning from cardiopulmonary bypass' (14.3% vs 28.2%), and 'refractory ventricular failure' (6.2% vs 9.8%). One out of five patients in both groups was listed as 'cardiogenic shock' (18.9% US vs 20.2% non-US). All cause, risk-adjusted, in-hospital mortality (20.1% vs 28.7%; P<0.001), and mortality with IABP in place (10.8% vs 18.0%; P<0.001) were lower at US vs non-US sites. In both US and non-US institutions, IABP associated complication rates, such as IABP-related mortality (0.05% vs 0.07%), major limb ischaemia (0.9% vs 0.8%), and severe bleeding (0.9% vs 0.8%), were low., Conclusions: IABP counterpulsation is deployed at an earlier clinical stage in US patients. Mortality rates are higher for non-US patients, particularly for patients with non-surgery cardiac interventions, even after adjusting for risk factors. Complication rates were low. Physicians should therefore not be reluctant to use IABP in high-risk patients undergoing cardiac procedures.