Abstract The role and timing of percutaneous mechanical circulatory support (MCS) devices in the treatment of acute myocardial infarction complicated by cardiogenic shock (AMICS) is not well ...understood. We sought to evaluate patient characteristics and predictors of outcomes in patients presenting with AMICS supported with an axial flow percutaneous MCS device. 287 consecutive unselected patients enrolled in the cVAD Registry presenting with AMICS who underwent percutaneous coronary intervention (PCI) were included in this analysis. All patients were supported with either the Impella 2.5 or Impella CP. Mean patient age was 66±12.5 years, 76% were male, mean left ventricular ejection fraction was 25 ±12 %. Prior to receiving MCS, 80% of patients required inotropes or vasopressors and 40% were supported with intra-aortic balloon pump. 9% of patients were under active cardiopulmonary resuscitation at the time of MCS implantation. Survival to discharge was 44%. In a multivariate analysis early implantation of a MCS device prior to PCI (p=0.04) and prior to requiring inotropes and vasopressors (p=0.05) was associated with increased survival. Survival was 66% when MCS was initiated <1.25 hours from shock onset, 37% when initiated within 1.25-4.25 hours, and 26% when initiated after 4.25 hours (p=0.017). Survival was 68%, 46%, 35%, 35%, 26% for patients requiring 0, 1, 2, 3, ≥4 inotropes prior to MCS support respectively (P<0.001). In conclusion, MCS implantation early after shock onset, before initiation of inotropes or vasopressors and prior to PCI, is independently associated with improved survival in patients presenting with AMICS.
Objective
The ‘Detroit Cardiogenic Shock Initiative’ is a single‐arm, multicenter study to assess the feasibility of early mechanical circulatory support (MCS) in patients who present with acute ...myocardial infarction complicated by cardiogenic shock (AMICS) who undergo percutaneous coronary intervention.
Methods
Between July 2016 and February 2017, 4 metro Detroit sites participated in the study. The centers agreed to treat patients with AMICS using a mutually agreed‐upon protocol emphasizing invasive hemodynamic monitoring and rapid initiation of MCS. Inclusion and exclusion criteria mimicked those from the ‘SHOCK’ trial with an additional exclusion criteria being use of intra‐aortic balloon pump counter pulsation prior to MCS.
Results
A total of 41 consecutive patients were included. Patients had an average age of 65 ± 14 years, 71% were male and 59% of patients were admitted to the hospital in cardiogenic shock. Prior to receiving MCS, 93% of patients were on vasopressors or inotropes, 15% of patients had a witnessed out of hospital cardiac arrest, 27% of patients had an in‐hospital cardiac arrest, and 17% were under active cardiopulmonary resuscitation while MCS was being implanted. In accordance to the protocol recommendation, 66% of patients had a MCS device inserted prior to PCI. Right heart catheterization and hemodynamic monitoring was performed in 83% of patients. Door to support times averaged 83 ± 58 minutes and 71% of patients were able to reduce the levels of inotropes and vasopressors within the first 24‐hours of their index procedure. Pre‐procedure cardiac power output (CPO) was 0.57 W and post‐procedure CPO was 0.95 W, a 67% increase (p < 0.001). Survival to explant for the entire cohort was 85% a significant improvement from institutional historical controls (85% vs 51% p < 0.001) and survival to discharge was 76%.
Conclusion
Centers who adopted a regional shock protocol emphasizing the delivery of early MCS with invasive hemodynamic monitoring can achieve rapid door to support times and can improve survival in patients who present with AMICS. Larger national studies will be needed to further validate this pilot feasibility study.
Objectives This study sought to evaluate the safety and efficacy of the CoreValve transcatheter heart valve (THV) for the treatment of severe aortic stenosis in patients at extreme risk for surgery. ...Background Untreated severe aortic stenosis is a progressive disease with a poor prognosis. Transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis is a potentially effective therapy. Methods We performed a prospective, multicenter, nonrandomized investigation evaluating the safety and efficacy of self-expanding TAVR in patients with symptomatic severe aortic stenosis with prohibitive risks for surgery. The primary endpoint was a composite of all-cause mortality or major stroke at 12 months, which was compared with a pre-specified objective performance goal (OPG). Results A total of 41 sites in the United States recruited 506 patients, of whom 489 underwent attempted treatment with the CoreValve THV. The rate of all-cause mortality or major stroke at 12 months was 26.0% (upper 2-sided 95% confidence bound: 29.9%) versus 43.0% with the OPG (p < 0.0001). Individual 30-day and 12-month events included all-cause mortality (8.4% and 24.3%, respectively) and major stroke (2.3% and 4.3%, respectively). Procedural events at 30 days included life-threatening/disabling bleeding (12.7%), major vascular complications (8.2%), and need for permanent pacemaker placement (21.6%). The frequency of moderate or severe paravalvular aortic regurgitation was lower 12 months after self-expanding TAVR (4.2%) than at discharge (10.7%; p = 0.004 for paired analysis). Conclusions TAVR with a self-expanding bioprosthesis was safe and effective in patients with symptomatic severe aortic stenosis at prohibitive risk for surgical valve replacement. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902 )
Ventricular septal myomectomy (VSM) is the primary modality for left ventricular outflow tract gradient reduction in patients with obstructive hypertrophic cardiomyopathy with refractory symptoms. ...Comprehensive postprocedural data for VSM from a large multicenter registry are sparse. The primary objective of this study was to evaluate postprocedural mortality, complications, length of stay (LOS), and cost of hospitalization after VSM and to further appraise the multivariate predictors of these outcomes. The Healthcare Cost and Utilization Project's Nationwide Inpatient Sample was queried from 1998 through 2010 using International Classification of Diseases, Ninth Revision, procedure codes 37.33 for VSM and 425.1 for hypertrophic cardiomyopathy. The severity of co-morbidities was defined using the Charlson co-morbidity index. Hierarchical mixed-effects models were generated to identify independent multivariate predictors of in-hospital mortality, procedural complications, LOS, and cost of hospitalization. The overall mortality was 5.9%. Almost 9% (8.7%) of patients had postprocedural complete heart block requiring pacemakers. Increasing Charlson co-morbidity index was associated with a higher rate of complications and mortality (odds ratio 2.41, 95% confidence interval 1.17 to 4.98, p = 0.02). The mean cost of hospitalization was $41,715 ± $1,611, while the average LOS was 8.89 ± 0.35 days. Occurrence of any postoperative complication was associated with increased cost of hospitalization (+$33,870, p <0.001) and LOS (+6.08 days, p <0.001). In conclusion, the postoperative mortality rate for VSM was 5.9%; cardiac complications were most common, specifically complete heart block. Age and increasing severity of co-morbidities were predictive of poorer outcomes, while a higher burden of postoperative complications was associated with a higher cost of hospitalization and LOS.
Management of patients requiring temporary, mechanical hemodynamic support during high- risk percutaneous coronary intervention (PCI) or in cardiogenic shock is rapidly evolving. With the ...availability of the Impella 2.5, CP, 5.0, LD, and RP percutaneous mechanical circulatory support devices, there is a need for continued surveillance of outcomes.
Three factors underline the importance of a registry for these populations. First, large randomized trials of hemodynamic support, involving cardiogenic shock, are challenging to conduct. Second, there is increasing interest in the use of registries to provide “real-world” experience and to allow the flexibility to evaluate individual patient uses and outcomes. Third, current, large databases have not captured the specific impact of mechanical support treatment of cardiogenic shock.
The predecessor to the catheter-based ventricular assist devices registry, known as USpella, began in 2009 with paper data acquisition but beginning in 2011 transferred to electronic data capture, enrolling 3,339 patients through 2016. Throughout, registry data have been used to assess the outcomes of Impella therapy, leading to 8 publications and 4 Food and Drug Administration premarket approvals covering multiple indications and Impella devices.
Going forward, the registry will continue to assess not only in-hospital outcomes but long-term follow-up to 1 year. In addition, data management will be enhanced to assess quality and clinical experiences. The registry will also provide a mechanism for postmarketing surveillance.
This manuscript reviews the ongoing catheter-based ventricular assist devices registry design, management, and contributions of the registry data. The upgraded registry will provide a more robust opportunity to assess acute and late outcomes of current and future device use worldwide.
The current catheter-based ventricular assist devices registry is an international database documenting outcomes with temporary Impella hemodynamic support. The registry has supported 8 publications and 4 Food and Drug Administration premarket approvals since its inception in 2009. The current registry is more robust containing outcomes up to 1 year postprocedure.
With rates of ECMO utilization on the rise, prevention of nosocomial infections is of paramount importance. Candida auris, an emerging highly pathogenic multidrug resistant fungus, is of particular ...concern as it is associated with persistent colonization of environmental surfaces, inability to be recognized by many diagnostic platforms, inconsistent laboratory susceptibility results, and high mortality rates. We describe a case of C. auris in a VV-ECMO patient successfully managed with a combination of anidulafungin, amphotericin B, and flucytosine.
Contemporary practices for hemodynamically supported high-risk percutaneous coronary intervention have evolved over the last decade. This study sought to compare outcomes of the prospective, ...multicenter, PROTECT III study to historic patients treated with Impella in the PROTECT II randomized controlled trial.
Of 1,134 patients enrolled in PROTECT III from March 2017 to March 2020, 504 were “PROTECT II-like” (met eligibility for PROTECT II randomized controlled trial) and are referred to as PROTECT III for comparative analysis. Major adverse cardiac and cerebrovascular events (MACCE), comprising all-cause mortality, stroke/transient ischemic attack, myocardial infarction, and repeat revascularization, were compared at hospital discharge and 90 days.
Compared with PROTECT II (N = 216), PROTECT III patients were less often Caucasian (77.1% vs 83.8%, P = .045), with less prior CABG (13.7% vs 39.4%; P < .001) and prior myocardial infarction (40.7% vs 69.3%; P < .001). More PROTECT III patients underwent rotational atherectomy (37.1% vs 14.8%, P < .001) and duration of support was longer (median 1.6 vs 1.3 hours; p<0.001), with greater improvement achieved in myocardial ischemia jeopardy scores (7.0±2.4 vs 4.4±2.9; P < .001) and SYNTAX scores (21.4±10.8 vs 15.7±9.5; P < .001). In-hospital bleeding requiring transfusion was significantly lower in PROTECT III (1.8% vs 9.3%; P < .001), as was procedural hypotension (2.2% vs 10.1%; P < .001) and cardiopulmonary resuscitation or ventricular arrhythmia (1.6% vs 6.9%; P < .001). At 90 days, MACCE was 15.1% and 21.9% in PROTECT III and PROTECT II, respectively (p=0.037). Following propensity score matching, Kaplan-Meier analysis showed improved 90-day MACCE rates in PROTECT III (10.4% vs 16.9%, P = .048).
The PROTECT III study demonstrates improved completeness of revascularization, less bleeding, and improved 90-day clinical outcomes compared to PROTECT II for Impella-supported high-risk percutaneous coronary intervention among patients with severely depressed LVEF.
Objectives
To evaluate the periprocedural characteristics and outcomes of patients supported with Impella 2.5 prior to percutaneous coronary intervention (pre‐PCI) versus those who received it after ...PCI (post‐PCI) in the setting of cardiogenic shock (CS) complicating an acute myocardial infarction (AMI).
Background
Early mechanical circulatory support may improve outcome in the setting of CS complicating an AMI. However, the optimal timing to initiate hemodynamic support has not been well characterized.
Methods
Data from 154 consecutive patients who underwent PCI and Impella 2.5 support from 38 US hospitals participating in the USpella Registry were included in our study. The primary end‐point was survival to discharge. Secondary end‐points included assessment of patients' hemodynamics and in‐hospital complications. A multivariate regression model was used to identify independent predictors for mortality.
Results
Both groups were comparable except for diabetes (P = 0.02), peripheral vascular disease (P = 0.008), chronic obstructive pulmonary disease (P = 0.05), and prior stroke (P = 0.04), all of which were more prevalent in the pre‐PCI group. Patients in the pre‐PCI group had more lesions (P = 0.006) and vessels (P = 0.01) treated. These patients had also significantly better survival to discharge compared to patients in the post‐PCI group (65.1% vs.40.7%, P = 0.003). Survival remained favorable for the pre‐PCI group after adjusting for potential confounding variables. Initiation of support prior to PCI with Impella 2.5 was an independent predictor of in‐hospital survival (Odds ratio 0.37, 95% confidence interval: 0.17–0.79, P = 0.01) in multivariate analysis. The incidence of in‐hospital complications included in the secondary end‐point was similar between the 2 groups.
Conclusions
The results of our study suggest that early initiation of hemodynamic support prior to PCI with Impella 2.5 is associated with more complete revascularization and improved survival in the setting of refractory CS complicating an AMI. (J Interven Cardiol 2014;27:1–11)
Background
Protection against acute kidney injury (AKI) has been reported with the use of Impella during high‐risk percutaneous coronary intervention (HR‐PCI). We sought to evaluate this finding by ...determining the occurrence of AKI during Impella‐supported HR‐PCI in patients from the Global cVAD Study and compare this incidence with their calculated AKI risk at baseline.
Methods and Results
In this prospective, multicenter study, we enrolled 314 consecutive patients. We included 223 patients that underwent nonemergent HR‐PCI supported with Impella 2.5 or Impella CP and excluded those requiring hemodialysis prior to HR‐PCI (19) and those with insufficient data (72). The primary outcome was AKI postprocedurally at 48 hr versus the predicted risk of AKI according to Mehran risk score. Logistic regression analysis determined predictors of AKI. Overall, 4.9% (11) of Impella‐supported patients developed AKI (exclusively stage 1) at 48 hr versus a predicted rate of 21.9%, representing a 77.6% lower AKI rate (p < .0001). In this study, no Impella‐supported patients required renal replacement therapy. Estimated glomerular filtration rate (ml/min/1.73 m2) alone predicted AKI (adjusted odds ratio AOR: 4.915; 95% confidence intervals CI: 1.02–23.53, p = .046), and increasing contrast had insignificant effects on AKI during high‐risk PCI (AOR: 1.15; 95% CI: 0.87–1.51, p = .332). In patients not protected from AKI, the postprocedure incidence of AKI was not significantly greater and did not correlate with chronic kidney disease severity.
Conclusion
The incidence of AKI was lower during HR‐PCI than expected from current risk models. Although further exploration of this finding is warranted, these data support a new protective strategy against AKI during HR‐PCI.
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