Improved outcomes in patients with severely depressed LVEF undergoing percutaneous coronary intervention with contemporary practices.

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Identifying opportunities to advance health equity in interventional cardiology: Structural heart disease.

Health care practices are influenced by variety of factors. These factors that include social determinants, race and ethnicity, and gender not only affect access to health care but can also affect quality of care and patient outcomes. These are a source of health care disparities. This article acknowledges that these disparities exist in getting optimal care in structural heart disease, reviews the literature and proposes steps that can help reduce these disparities on personal and committee levels.

Unloading the Left Ventricle Before Reperfusion in Patients With Anterior ST-Segment-Elevation Myocardial Infarction.

BACKGROUND: In ST-segment-elevation myocardial infarction (STEMI), infarct size correlates directly with heart failure and mortality. Preclinical testing has shown that, in comparison with reperfusion alone, mechanically unloading the left ventricle (LV) before reperfusion reduces infarct size and that 30 minutes of unloading activates a cardioprotective program that limits reperfusion injury. The DTU-STEMI pilot trial (Door-To-Unload in STEMI Pilot Trial) represents the first exploratory study testing whether LV unloading and delayed reperfusion in patients with STEMI without cardiogenic shock is safe and feasible. METHODS: In a multicenter, prospective, randomized exploratory safety and feasibility trial, we assigned 50 patients with anterior STEMI to LV unloading by using the Impella CP followed by immediate reperfusion (U-IR) versus delayed reperfusion after 30 minutes of unloading (U-DR). The primary safety outcome was a composite of major adverse cardiovascular and cerebrovascular events at 30 days. Efficacy parameters included the assessment of infarct size by using cardiac magnetic resonance imaging. RESULTS: All patients completed the U-IR (n=25) or U-DR (n=25) protocols with respective mean door-to-balloon times of 72 versus 97 minutes. Major adverse cardiovascular and cerebrovascular event rates were not statistically different between the U-IR versus U-DR groups (8% versus 12%, respectively, P=0.99). In comparison with the U-IR group, delaying reperfusion in the U-DR group did not affect 30-day mean infarct size measured as a percentage of LV mass (15±12% versus 13±11%, U-IR versus U-DR, P=0.53). CONCLUSIONS: We report that LV unloading using the Impella CP device with a 30-minute delay before reperfusion is feasible within a relatively short time period in anterior STEMI. The DTU-STEMI pilot trial did not identify prohibitive safety signals that would preclude proceeding to a larger pivotal study of LV unloading before reperfusion. An appropriately powered pivotal trial comparing LV unloading before reperfusion to the current standard of care is required. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03000270.

Impella support and acute kidney injury during high-risk percutaneous coronary intervention: The Global cVAD Renal Protection Study.

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.

Temporal trends in peripheral arterial interventions: Observations from the blue cross blue shield of michigan cardiovascular consortium (BMC2 PVI).

OBJECTIVES: The aim is to examine trends in procedural indication, arterial beds treated, and device usage in peripheral arterial interventions (PVIs). BACKGROUND: There is little data on indication, vascular beds treated and devices utilized for peripheral arterial interventions. METHODS: We used data from 43 hospitals participating in the BMC2 VIC registry. PVIs were separated by year and divided by arterial segment. Lower extremity PVIs were subclassified as having been performed for claudication or critical limb ischemia (CLI). Yearly device usage was also included. A repeated measure ANOVA was used to determine trends. RESULTS: 44,650 PVIs were performed from 2006 to 2013. Renal interventions decreased from 18% of interventions in 2006 to 5.6% in 2013 (P < 0.001) and femoral-popliteal increased from 54.9% in 2006 to 64.5% in 2013 (P < 0.001). No significant trend was seen for aorta-iliac or below-the-knee interventions. 58.6% of PVIs were performed for claudication in 2006 and this decreased to 44.6% in 2013 (P = 0.025). Indications for CLI were 24.1% in 2006 and 47.5% in 2013 (P < 0.001). There were significant increases in the use of balloon angioplasty (P = 0.029) and cutting/scoring balloons (P < 0.001) while cryoballoon usage decreased (P < 0.001). No significant changes were found with stenting, atherectomy, and laser. CONCLUSIONS: There is a significant increase in patients presenting with CLI. Renal artery intervention rates are decreasing while femoral-popliteal interventions are increasing. Additionally, balloon angioplasty and cutting/scoring balloon usage is increasing. © 2017 Wiley Periodicals, Inc.

Contrast-induced nephropathy in patients undergoing endovascular peripheral vascular intervention: Incidence, risk factors, and outcomes as observed in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium.

BACKGROUND: The incidence, risk factors, and outcomes associated with Contrast-induced nephropathy (CIN) after Percutaneous Vascular Intervention (PVI) in contemporary medical practice are largely unknown. METHODS: A total of 13 126 patients undergoing PVI were included in the analysis. CIN was defined as an increase in serum creatinine from pre-PVI baseline to post-PVI peak Cr of ≥0.5 mg/dL. RESULTS: CIN occurred in 3% (400 patients) of the cohort, and 26 patients (6.5%) required dialysis. Independent predictors of CIN were high and low body weight, diabetes, heart failure, anemia, baseline renal dysfunction, critical limb ischemia, and a higher acuity of the PVI procedure and a contrast dose that was greater than three times the calculated creatinine clearance (CCC) (adjusted OR 1.4, 95% CI: 1.1-1.8, P = 0.003). CIN was strongly associated with adverse outcome including in-hospital death (adjusted OR 18.1, CI 10.7-30.6, P < 0.001), myocardial infarction (adjusted OR 16.2, CI 8.9-29.5, P < 0.001), transient ischemic attack/stroke (adjusted OR 5.5, CI 3.2-14.9, P = 0.001), vascular access complications (adjusted OR 3.4, CI 2.3-5, P < 0.001), and transfusion (adjusted OR 7, CI 5.4-9, P < 0.001). Hospital stay was longer in patients who developed CIN versus those who did not. CONCLUSIONS: CIN is not an uncommon complication associated with PVI, can be reliably predicted from pre-procedural variables, including a contrast dose of greater than three times the CCC and is strongly associated with the risk of in-hospital death, MI, stroke, transfusion, and increased hospital length of stay.

Percutaneous Coronary Intervention: 2015 in Review.

In order to keep the interventional community up-to-date with the overwhelming amount of new data, we have selected where we believe to be the most important publications in percutaneous coronary intervention from January 1, 2015 to mid-November 2015. We hope that this will serve as an important overview of 2015, and ongoing reference for future years.

Endovascular Interventional Cardiology: 2015 in Review.

Minimally invasive interventional procedures have become an appealing option for patients with endovascular disease historically referred to surgery. This article reviews the major advancements and trials published in 2015.

Operational Implications of Utilizing 2 Advanced Technologies for Rendering Short-term Hemodynamic Support to Patients Presenting With Cardiogenic Shock: A View Through the Lens of Hospital Readmissions.

PURPOSE: Reducing hospital readmissions for critically ill patients is of concern to payers and providers alike. Patients in cardiogenic shock are often treated with devices to help support the functions of the heart while the patient undergoes treatment. This study compares the readmission experience of Medicare beneficiaries treated for cardiogenic shock (CS) using percutaneous ventricular assist devices (pVADs) vs. extracorporeal membrane oxygenation (ECMO), two types of advanced cardiac support devices. Hospital readmission is a surrogate for quality and cost. DESIGN AND METHODOLOGY: A retrospective comparison of readmission patterns of patients treated for CS using two advanced cardiac support devices during calendar years 2011 and 2012 was captured via the Medicare Inpatient Standard Analytic File (100% census file). A total of 649 eligible cases (pVAD, 517; ECMO, 132) with 90 days of follow-up documentation were included in this analysis. Baseline characteristics were compared, including demographics, admission type, and severity of illness, with the 2 groups generating clinically similar baseline profiles. Primary outcomes include 30- and 90-day readmissions, associated length of stay (LOS), and costs. RESULTS: At 90 days after initial hospitalization, the readmission rates in the pVAD and ECMO cohorts were 38.7% (200/517) and 53.0% (70/132), respectively. Overall, pVAD was associated with a 27.1% reduction in readmission (P = .004). With the use of pVAD, 90-day readmission costs were lower by $12,294 ($32,736 vs $20,442, a reduction of 37.6%, P=.02) and readmission LOS was shorter by approximately 8 days, (20.5 vs. 12.7 days, a 37.9% reduction, P = .002). Similar trends were observed at 30 days; however, only LOS was significantly reduced, by 7.0 days (P < .001). CONCLUSION: In clinically comparable cohorts, pVADs were associated with reduced risk of rehospitalization, lower cost, and shorter LOS, resulting in cost savings for payers and providers. Increased adoption of pVAD, as a technology to support patients in cardiogenic shock, may help hospitals deliver greater value to both government and commercial payers.

Treatment of Candida auris during extracorporeal life support: A case report.

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.

Racial disparities in left main stenting: insights from a real world inner city population.

BACKGROUND: Left main coronary artery (LMCA) disease is associated with significant cardiovascular mortality. The data on patient characteristics' predicting outcomes after LMCA revascularization is sparse. METHODS: A retrospective study of 227 patients with LMCA disease documented on coronary angiography from March 2000 to December 2008. Data included demographic variables, co-morbidities, cardiac function, and medications. Race was self-identified. The study outcome was a composite end-point including myocardial infarction (MI) and all-cause mortality. Cox proportional hazard analysis was performed to study the effect of various patient attributes including race and gender on the composite end-point. RESULTS: Baseline characteristics were specifically compared between individuals who had the study outcome versus those who did not. Mean age was higher in the group with study outcomes when compared to the group without any outcomes (64.3 ± 11.8 years versus 59.2 ± 13.6 years; p = 0.013). After the final multivariate regression analysis, only African American (AA) race and age were found to be independent predictors of adverse cardiac outcome at the end of the first year (race-hazard ratio (HR) 3.82, 95% confidence interval (CI) 1.38-10.62, p = 0.010; age-HR 1.08, 95% CI 1.04-1.13, p < 0.001) and at the end of the study (race-HR 2.71, 95% CI 1.44-5.10, p = 0.002; age-HR 1.03, 95% CI 1.01-1.08, p = 0.017). CONCLUSION: In our study of patients with unprotected LMCA disease, AA race, and age were significantly predictive of poor prognosis following revascularization, while gender had no predictive value in prognosticating cardiovascular mortality.

Impella Mechanical Circulatory Support for Takotsubo Syndrome With Shock: A Retrospective Multicenter Analysis.

OBJECTIVES: To analyze the characteristics and outcome of Impella mechanical circulatory support (MCS) for Takotsubo syndrome (TS) with cardiogenic shock. BACKGROUND: TS is an acute heart failure syndrome characterized by transient severe reduction of left ventricular (LV) systolic function, with cardiogenic shock occurring in around 10% of patients. Since inotropes should be avoided due to their role in TS pathogenesis and aggravation of LV outflow tract obstruction, the use of MCS as treatment is a viable treatment option, however, studies are lacking. METHODS: The catheter-based ventricular assist device (cVAD) registry and local MCS databases were screened for TS patients with cardiogenic shock (TS-CS) supported with an Impella percutaneous ventricular assist device (pVAD). Patient and treatment characteristics and in-hospital outcomes were retrospectively analyzed. RESULTS: At 10 US and European centers, 16 TS-CS patients supported with an Impella pVAD were identified between December 2013 and May 2018 (mean age, 61.8 ± 15.5 years; 87.5% women). LV ejection fraction (LVEF) at presentation was severely reduced (mean, 19.4 ± 8.3%). Prior to MCS, 13 patients (81.3%) were mechanically ventilated, 4 patients (25.0%) had been resuscitated, and mean serum lactate was 4.7 ± 3.5 mmol/L. Mean duration of Impella support was 1.9 ± 1.0 days (range, 1-4 days). Thirteen patients (81.3%) survived to discharge, and all survivors experienced cardiac recovery with significant improvement of LVEF at discharge compared to baseline (20.4 ± 8.8 vs. 52.9 ± 12.0, P < 0.001). CONCLUSIONS: This is the first series of TS-CS patients supported with an Impella pVAD. Mortality was low, and LV systolic function recovered in all survivors. Prospective studies of Impella support in this special condition are warranted.

Cardiogenic Shock Complicating Acute Myocardial Infarction Treated With Percutaneous Coronary Intervention Supported by Impella: Implications of Advanced Age and Refractory Shock on Outcomes.

With percutaneous left ventricular mechanical circulatory support devices becoming increasingly available for patients with cardiogenic shock due to acute myocardial infarction and the lack of a clear mortality benefit to date, identifying optimal candidates for this technology is crucial. We studied the effectiveness of Impella Cardiac Pow (Abiomed, Danvers, MA) in various stages of cardiogenic shock and elderly cohorts. DESIGN: Retrospective review. SETTING: Data were collected for patients at a single community hospital between January 1, 2018, and December 31, 2019. SUBJECTS: Thirty-one consecutive adult patients with cardiogenic shock due to acute myocardial infarction who received Impella Cardiac Pow support. Shock stages were defined by the Society for Cardiovascular Angiography and Intervention (Stages A-E). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The primary outcome was in-hospital death across Society for Cardiovascular Angiography and Intervention cardiogenic shock stages and in patients greater than or equal to 80 and less than 80 years old. Secondary outcomes were Valve Academic Research Consortium-2 vascular and bleeding complications, stroke, and renal failure requiring dialysis. The median age of the study population was 64 years, with seven patients (23%) being greater than or equal to 80 years old. No patients were in Society for Cardiovascular Angiography and Intervention Stage A, whereas there were seven in B, eight in C, six in D, and 10 (32%) in E. Overall in-hospital mortality occurred in 61% of patients. All 10 patients in Stage E died before hospital discharge. Mortality occurred in 54% of patients (13/24) age less than 80 years compared with 86% of those 80 years or older (6/7). A total of 38.7% of patients (12/31) and 32.3% of patients (10/31) experienced Valve Academic Research Consortium-2 bleeding and vascular events, which were evenly distributed across Society for Cardiovascular Angiography and Intervention cardiogenic shock Stages. CONCLUSIONS: In conclusion, patients with shock in extremis and those 80 years old and older may have a prohibitively high mortality despite Impella use. These findings merit further prospective investigation in a larger number of patients to evaluate the effectiveness of Impella (and other left ventricular mechanical circulatory devices) and the inherent resource utilization in advanced cardiogenic shock and the elderly.

Comparison of five-year outcome in African Americans versus Caucasians following percutaneous coronary intervention.

BACKGROUND: Studies regarding short-term outcomes after percutaneous coronary intervention (PCI) have reported no ethnic differences and data on long-term follow-up is conflicting and sparse. METHODS: 730 consecutive patients (67% African American) undergoing PCI from January 1999 to December 2000 at a tertiary care center in Detroit, MI, were followed up. End points studied included either all cause mortality collected from Social Security Death Index or first hospital admission after the index procedure due to myocardial infarction(MI), congestive heart failure(CHF), and revascularization (PCI or coronary artery bypass graft surgery). RESULTS: African-Americans undergoing PCI had significant differences in baseline cardiovascular co-morbidity and were more likely to present with acute myocardial infarction than Caucasians. On Kaplan Meier survival analysis and log rank test, each ethnic group had equivalent survival for cumulative end points upto 6-month follow-up, however longer follow-up to 5 year was characterized by lower survival rate in African Americans compared to Caucasians (41% vs. 54%, log rank P 0.01). After adjustment for potential confounders, AA ethnicity (Adjusted HR 1.62, 95% CI 1.01-1.28, P 0.04) remained a predictor of adverse cardiac outcome (Death/MI/CHF) at five-year follow-up (Cox regression propensity adjusted hazard analysis). CONCLUSIONS: African American patients undergoing PCI had unfavorable baseline cardiovascular characteristics but comparable short-term outcome compared to whites. However, at 5-year follow-up, African Americans had worse clinical outcome, higher incidence of acute myocardial infarction, congestive heart failure and significantly lower long-term survival.

Successful Treatment of Occlusive Left Main Coronary Artery Dissection by Impella-Supported Stenting.

We report successful treatment of a patient, who, during diagnostic angiography, developed an ostial left main coronary artery dissection with stump occlusion of the vessel. First, mechanical circulatory support with an Impella CP device was established. Then, patency of the left coronary system was achieved by placement of stents in the left anterior descending, left circumflex, and left main coronary arteries. On completion of the procedure, left ventricular systolic function, as assessed by echocardiography, was normal. At 24-month clinical follow-up, the patient remains angina-free and well. This is the first reported case of the use of an Impella device to support treatment of iatrogenic left main coronary artery dissection.

Transcatheter bicuspid aortic valve replacement in Turner syndrome: A unique experience of interventional cardiologist.

A 69-year-old short-statured Turner syndrome (TS) patient with a history of poliomyelitis in childhood and moderate bicuspid aortic stenosis (BAS) reported worsening dyspnea and fatigue over six months. A repeat transthoracic echocardiogram revealed progression to severe aortic stenosis with dilated ascending aorta (AA). As part of the work-up for aortic valve replacement, the patient underwent cardiac catheterization, which revealed a severely calcified AV with an area of 0.5 sq. cm and a mean gradient of 37 mmHg. On coronary angiography, there was 70% stenosis of the proximal left anterior descending artery (LAD). Due to poor rehabilitation potential, she was deemed high-risk for surgical aortic valve replacement. A recommendation for transcatheter aortic valve replacement (TAVR) with stenting of the proximal LAD was made. Dilated AA was managed conservatively with serial noninvasive imaging. The patient underwent TAVR with Edwards-Sapien valve (23 mm S3) and stenting of proximal LAD. The procedure was successful without complications. To our knowledge, our patient is the first case of TAVR in BAS with aortopathy in TS. .

Comparison of Outcomes of Percutaneous Coronary Intervention on Native Coronary Arteries Versus on Saphenous Venous Aorta Coronary Conduits in Patients With Low Left Ventricular Ejection Fraction and Impella Device Implantation Achieved or Attempted (from the PROTECT II Randomized Trial and the cVAD Registry).

Patients with prior coronary artery bypass grafting (CABG) represent a high-risk cohort given associated medical conditions and worse outcome of saphenous vein graft compared with native vessel percutaneous coronary intervention (PCI). The goal of the current analysis was to compare clinical outcomes in 591 patients with and without prior CABG and multivessel coronary artery disease or unprotected left main disease and severely reduced left ventricular systolic function underwent Impella supported PCI from the PROTECT II randomized trial and the cVAD Registry. Patients with prior CABG surgery (n = 201) were compared with those without prior CABG surgery (n = 390). The primary end point of this analysis was overall mortality at 30 days. Patients with prior CABG surgery had greater Society of Thoracic Surgery mortality score compared with patients without prior CABG surgery, 7.6 ± 6.4 versus 5.1 ± 5.5, respectively, p <0.001. Saphenous vein graft PCI was performed in 17% of patients with prior CABG surgery. Number of vessels treated was lower in patients with prior CABG surgery compared with patients without prior CABG surgery, 1.66 ± 0.56 versus 1.89 ± 0.64, respectively, p <0.001. Achievement of TIMI 3 flow post PCI and overall PCI success was similar in the two groups. Overall mortality at 30 days was similar in patients with prior CABG surgery compared with patients without prior CABG surgery, 6.75% versus 6.61%, respectively, p = 1.0. In conclusion, in this high-risk cohort of patients underwent hemodynamically supported PCI, prior CABG surgery was not associated with worse outcome. The use of hemodynamic support appears to mitigate the increased risk of PCI associated with prior CABG.