Ischemic Versus Bleeding Outcomes After Percutaneous Coronary Interventions in Patients With High Bleeding Risk.

Patients undergoing percutaneous coronary intervention (PCI) often have high-bleeding-risk (HBR) factors. Dual antiplatelet therapy (DAPT) further increases this risk of bleeding. We sought to compare clinical outcomes according to presence or absence of HBR factors in patients with elevated ischemic risk (DAPT score ≥ 2) undergoing PCI. We evaluated all patients undergoing PCI at MedStar Washington Hospital Center (January 2009 to July 2018) with DAPT score ≥2, which is associated with elevated risk of ischemic events. Patients were categorized as HBR group (HBR score ≥1) or low-bleeding-risk (LBR) group (HBR score = 0). Outcomes included major adverse cardiac events such as target vessel revascularization, stent thrombosis, death, and bleeding events at 30 days, 6 months, 1 year, and 2 years. The final cohort consisted of 7,499 patients: 3,949 patients had LBR features, and 3,550 patients had HBR features. The 2 groups were different at baseline, with HBR patients being older and having a higher prevalence of congestive heart failure and renal dysfunction than the LBR group. The mean DAPT score was 2.96±1.1 for the LBR group and 3.7±1.4 for the HBR group (p <0.001). During follow-up at 30 days, 6 months, and 1 and 2 years, the rates of target vessel revascularization and stent thrombosis were not significantly different between the 2 groups. Bleeding events and all-cause mortality were significantly more frequent in the HBR group than in the LBR group. In conclusion, patients undergoing PCI often have pre-existing risk factors that predispose them to ischemic and bleeding complications. Prolonged duration of DAPT to mitigate ischemic events could lead to a disproportionate increase in bleeding events, especially in HBR patients.

Should Non-ST-Elevation Myocardial Infarction be Treated like ST-Elevation Myocardial Infarction With Shorter Door-to-Balloon Time?

It is estimated that each year in the United States >780,000 persons will experience an acute coronary syndrome. Approximately 70% of these will have non-ST-elevation myocardial infarction (NSTEMI). Optimal timing of angiography in NSTEMI is a matter of debate. The aim of this retrospective analysis was to evaluate whether and how the timing of percutaneous coronary intervention (PCI) affects the 1-year rate of major adverse cardiac events (MACE) in patients presenting with NSTEMI. Within our PCI database, we identified 1550 patients who underwent PCI for NSTEMI. We then divided the population into 3 groups based on door-to-balloon time (D2BT) (group 1 = D2BT <90 minutes; group 2 = D2BT >90 minutes <24 hours; group 3 = D2BT >24 hours). Primary outcome was MACE, a composite of MI, death and target vessel revascularization (TVR), or TVR at 1 year. Baseline characteristics were heterogeneous among the 3 groups, with patients who underwent angiograms >24 hours from presentation being older with more cardiovascular co-morbidities. Patients with D2BT <90 minutes were more likely to present with cardiogenic shock and had higher troponin levels. In-hospital mortality was similar among the 3 groups, but 1-year MACE/TVR was significantly higher in groups 1 and 3, driven by worse mortality. In this large cohort of patients presenting with NSTEMI, patients who underwent PCI between 90 minutes to 24 hours from presentation had better 1-year outcomes but also had fewer co-morbidities and with significantly lower prevalence of cardiogenic shock and high troponin on presentation. Therefore, treatment selection bias makes causal inference concerning rapid revascularization and outcome unreliable. Randomized clinical trials are warranted to assess outcome of rapid revascularization in patients presenting with NSTEMI.

Racial Disparities in Clinical Characteristics and Outcomes of Women Undergoing Percutaneous Coronary Intervention.

BACKGROUND/PURPOSE: Women are underrepresented in cardiovascular clinical studies. Black women have a higher ischemic heart disease mortality risk than their white counterparts. However, there exist limited outcome data comparing black women and white women after percutaneous coronary intervention (PCI). The aim of this retrospective analysis was to evaluate for racial disparities in 1-year major adverse cardiovascular events (MACE) in women undergoing PCI. METHODS/MATERIALS: Within our PCI database, we identified 4776 female patients who underwent PCI between 2003 and 2016. Of those, 1916 were black and 2860 were white. Endpoints included MACE, death, myocardial infarction, target vessel revascularization (TVR) and stent thrombosis (ST) at 30 days and 1 year. A proportional Cox hazard model analysis was performed to assess outcomes after adjustment for confounding factors. RESULTS: Black women presented at a younger age and had a significantly higher prevalence of risk factors. Periprocedural and in-hospital outcomes were similar in the 2 groups. At 30 days and 1 year, the rates of myocardial infarction, TVR and ST were significantly higher in black women. After adjustment for baseline differences, only ST appears to be more likely to occur in black women than in white women. CONCLUSIONS: In this large cohort of women with coronary artery disease undergoing PCI, we observed racial disparities primarily in baseline characteristics indicative of need for interventions to achieve early diagnosis and better prevention in black women. Future directions should include efforts to identify and better characterize the factors underlying and contributing to cardiovascular outcomes in women after PCI. SUMMARY: In this real-world analysis from a large cohort of women with coronary artery disease undergoing percutaneous coronary intervention at a US tertiary-care center, racial disparities were observed, especially in baseline characteristics, indicating late presentation.

Trends in Death Rate 2009 to 2018 Following Percutaneous Coronary Intervention Stratified by Acuteness of Presentation.

Percutaneous coronary intervention (PCI) has evolved dramatically, along with patient complexity. We studied trends in in-hospital mortality with changes in patient complexity over the last decade stratified by clinical presentation. The study population included all patients presenting to the cardiac catheterization lab between January 2009 and July 2018. Expected in-hospital mortality was calculated using the National Cardiovascular Data Registry CathPCI risk scoring system. Yearly mean in-hospital mortality rates (%) were plotted and smoothed by weighted least squares regression for each presentation: ST-elevation myocardial infarction (STEMI), non-ST-elevation acute coronary syndrome (NSTE-ACS), and stable ischemic coronary artery disease (SI CAD). The overall cohort included 13,732 patients who underwent PCI during the study period, of whom 2,142 were for STEMI, 2,836 for NSTE-ACS, and 8,754 for SI CAD. Indications for PCI have changed over time, with more PCIs being performed for NSTE-ACS and STEMI than for SI CAD. NSTE-ACS and STEMI patients had a steady decrease in in-hospital mortality over time compared with SI CAD patients. Overall observed mortality continues to decrease in NSTE-ACS patients, with reduction in the observed mortality rate within the STEMI population to below expected since 2013. Patient complexity has not changed significantly. These results may be attributed to improved patient selection coupled with optimal pharmacotherapy with more robust therapies during procedure and hospitalization.

Restenosis of Drug-Eluting Stents: A New Classification System Based on Disease Mechanism to Guide Treatment and State-of-the-Art Review.

Despite on-going evolution and iteration of drug-eluting stent (DES) technology, the prevalence of in-stent restenosis (ISR) remains relatively unchanged, encompassing ≈10% of percutaneous coronary interventions. The mechanism of ISR is multifactorial, including biological, mechanical, patient, and operator-related factors. The main mechanical contributors are stent underexpansion or fracture, while biological factors include local inflammation leading to aggressive neointimal proliferation and late neoatherosclerosis. Intracoronary imaging is critical to identify the mechanism of ISR and tailor therapy accordingly. The presentation of DES-ISR is not benign and is challenging for optimal treatment. Among the proposed treatment modalities are scoring and high-pressure balloons, percutaneous coronary intervention with additional DES, atheroablative therapies by laser or mechanical atherectomy, drug-coated balloons, vascular brachytherapy, and surgical revascularization. We propose a new classification for ISR that differentiates among mechanical, biological, and mixed etiologies. Stratifying ISR by mechanism guides individualized treatment of DES-ISR to improve clinical outcomes. An algorithmic approach, guided by intracoronary imaging, for the treatment of DES-ISR, is recommended based on the specific cause of restenosis.

Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis and Prior External Chest Radiation.

BACKGROUND/PURPOSE: Surgical aortic valve replacement (SAVR) in patients with symptomatic severe aortic stenosis (AS) and prior chest radiation is associated with poor outcomes in comparison with patients without prior radiation. Our objective was to compare clinical outcomes of patients with and without prior chest radiation undergoing transcatheter aortic valve replacement (TAVR) for symptomatic severe AS. METHODS/MATERIALS: Between January 2003 and January 2017, 1150 patients underwent TAVR at our institution. Of these, 44 had prior chest radiation. Baseline demographic and clinical characteristics, procedural details, and clinical outcomes were prospectively collected. RESULTS: Patients with prior chest radiation were younger, 76 ±â€¯13 years, compared with those without prior chest radiation, 82 ±â€¯8 years (p = 0.002). Median Society of Thoracic Surgeons score for chest radiation patients was 7 ±â€¯4, compared to 8 ±â€¯5 in those without prior radiation. Despite higher prevalence of complete heart block, there was no significant difference between the 2 groups with regard to the need for permanent pacemaker implantation. There was a trend toward longer length of intensive care unit stay in chest radiation patients, but there was no significant difference in 30-day or 1-year mortality. CONCLUSIONS: Thus, TAVR appears to be a safe treatment option in the short and medium term for patients with symptomatic severe AS and prior chest radiation.

Adverse Events Associated with the Use of Guide Extension Catheters during Percutaneous Coronary Intervention: Reports from the Manufacturer and User Facility Device Experience (MAUDE) database.

BACKGROUND/PURPOSE: We aimed to assess the reported complications and event modes for the GuideLiner and Guidezilla extension catheters. METHODS/MATERIALS: The US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was queried for reported events. RESULTS: Of the 65 cases with reported GuideLiner-related issues, 15 (23%) involved the inability to pass equipment through or damage to percutaneous coronary intervention (PCI) devices in the GuideLiner catheter, 38 (58%) involved GuideLiner catheter fracture, 9 (14%) involved coronary artery dissection, 2 (3%) involved coronary artery perforation, and 1 (1.5%) involved thrombus formation in the catheter. Of the 408 cases with reported Guidezilla-related issues, 53 (13%) involved inability to pass or damaged PCI devices into the Guidezilla catheter, 117 (29%) involved inability to advance the Guidezilla catheter to the target lesion, 59 (14%) involved kinked Guidezilla catheter, mostly because of partial or complete catheter fracture upon further investigation, 164 (40%) involved a broken Guidezilla catheter, 10 (2.5%) involved coronary artery dissection, 2 (0.5%) involved coronary artery perforation, 1 (0.2%)involved aortic dissection, 1 (0.2%) involved thrombosis formation, and 1 (0.2%) involved no-reflow phenomenon. CONCLUSIONS: Findings from the MAUDE database highlight the complications and modes of events associated with the use of GuideLiner and Guidezilla extension catheters. SUMMARY: To assess the reported complications and event modes for the GuideLiner and Guidezilla extension catheters, the US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was queried. There were more reports on Guidezilla-related events during the search period. The events for both extension catheters mainly involved the inability to pass equipment through or damage to percutaneous coronary intervention (PCI) devices in the extension catheter, extension catheter fracture, coronary artery dissection and perforation and, occasionally, the death of the patients.

Techniques to Optimize the Use of Optical Coherence Tomography: Insights from the Manufacturer and User Facility Device Experience (MAUDE) Database.

BACKGROUND/PURPOSE: Optical coherence tomography (OCT) is a high-resolution intravascular imaging modality used to assess coronary arteries and as an adjunctive tool for optimization of percutaneous coronary interventions. Overall, the rate of complications and adverse events related to intravascular imaging is low. Limited data exist on the most commonly reported complications and modes of failure related to the use of OCT. Therefore, we analyzed the post-marketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to assess the reported complications and failure modes for OCT and reviewed techniques to optimize device use. METHODS/MATERIALS: The MAUDE database was queried for all event reports involving coronary OCT devices. Two independent reviewers identified 49 device reports included in the final analysis. Modes of failure and device-related patient complications were assessed. RESULTS: Of the 49 cases with reported device-related issues, 6.1% involved malfunction prior to insertion of the OCT catheter, and 30.6% of reported events did not result in an associated patient-related adverse event. The most commonly reported adverse events included coronary dissection and difficulty removing the catheter within a previously stented segment. No events of contrast-induced nephropathy were reported. CONCLUSIONS: Findings from the MAUDE database highlight the modes of device-related events associated with OCT. Device issues are uncommon, and as a result, users should be aware of optimal techniques to prevent and minimize adverse events related to device use.

Genetic and Nongenetic Implications of Racial Variation in Response to Antiplatelet Therapy.

Race has been identified as an independent risk factor for poor prognosis and an independent predictor of survival in coronary artery disease. Race-related dissimilarities have been identified in cardiovascular patients in terms of age of presentation, co-morbidities, socioeconomic status, and treatment approach as well as genetically driven race-related disparities in responsiveness to medications. Antiplatelet therapy represents a fundamental component of therapy in cardiovascular patients, especially in patients presenting with acute coronary syndromes. It has been argued that the different level of platelet reactivity and varying response to antiplatelet therapy among races may account in part for worse outcomes in certain populations. The purpose of this review is to describe genotypic and phenotypic race-related differences in platelet reactivity and responsiveness to cardiovascular treatment, focusing on antiplatelet therapy to highlight the need establish a more effective and targeted antithrombotic strategy.

Adverse Events and Modes of Failure Related to Impella RP: Insights from the Manufacturer and User Facility Device Experience (MAUDE) Database.

BACKGROUND/PURPOSE: Right ventricular (RV) mechanical circulatory support remains an important adjunctive therapy for RV failure refractory to medical therapy. Impella RP (Abiomed, Danvers, MA) is approved for providing temporary RV support for patients with acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. Robust data on the most commonly reported complications and failure modes for the Impella RP are lacking. We analyzed the post-marketing surveillance data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database to assess these endpoints. MATERIALS/METHODS: The MAUDE database was queried for the time period January 1, 2009, through December 31, 2018, for Impella devices by Searching for the following event types: "injury", "malfunction", "death", and "other". The search yielded 436 device reports. Impella RP medical device reports were screened, and 35 reports were included for the final analysis. RESULTS: In cases of reported complications, Impella RP was placed most commonly for right ventricular failure (RVF) developing in postcardiotomy patients (20%). The most commonly reported complications included bleeding (42.9%) and vascular complications (22.8%). The modes of failure included damage or fracture of the device elements (34.2%); thrombus, or clot in the system (17.1%); and device detachment (8.6%). CONCLUSIONS: Findings from the MAUDE database highlight the failure modes of the Impella RP device that should be addressed in order to improve the device performance and obtain improved clinical outcomes when utilized for RVF.

Overview of the 2018 US Food and Drug Administration Circulatory System Devices Panel meeting on the INCRAFT AAA Stent Graft System.

On June 12, 2018, the US Food and Drug Administration (FDA) convened a meeting of the Circulatory System Devices Panel to advise on the safety and effectiveness of the INCRAFT® AAA Stent Graft System for the treatment of abdominal aortic aneurysms (AAA) and to consider a premarket approval application sponsored by Cordis, Inc., for Unique identifier: NCT01664078 based on the results of the pivotal INSPIRATION trial (URL: https://clinicaltrials.gov/ct2/show/NCT01664078). The INCRAFT® AAA Stent Graft System is designed for endovascular repair of infrarenal AAAs with complex aortic anatomies. The stent-graft system utilizes nitinol stent and polyester graft technology in an ultra-low profile delivery system, with the goal of isolating the aneurysmal sac and preventing sac rupture. The multicenter, prospective, non-randomized investigation trial met its primary composite safety and effectiveness endpoints but also showed higher-than-anticipated rates of stent fracture and endoleaks. The committee discussion focused on how these events impact the long-term safety and effectiveness, as well as the benefit/risk profile, of the device. While the panel acknowledged the risk of the device, the panel's final vote supported that the benefits of the INCRAFT AAA Stent Graft System outweigh the risks and that a post-marketing study should be mandated. The FDA approved the device for use in complex access anatomies in December 2018.

Effects of Cangrelor as Adjunct Therapy to Percutaneous Coronary Intervention.

Percutaneous coronary intervention (PCI) in patients with angiographic evidence of intracoronary thrombus is associated with in-hospital and 30-day adverse clinical outcomes. Cangrelor, a direct, rapid-onset acting intravenous P2Y12 receptor inhibitor, has been proved to be effective by reducing peri-PCI ischemic complications in subjects who underwent PCI. This study aimed to assess the angiographic and in-hospital clinical outcomes in all-comer patients receiving cangrelor immediately before PCI at a tertiary care center. The study analyzed consecutive unselected subjects treated with cangrelor at the time the decision was made to proceed with PCI. At the end of the procedure, all patients were transitioned to oral antiplatelet therapy. The target lesion angiographic assessment of Thrombolysis in myocardial infarction flow grade (TIMI-Flow), TIMI-thrombus grade (TIMI-Thrombus), myocardial blush grade, and TIMI-myocardial perfusion grade (TMPG) was performed before and post-PCI. Clinical events were recorded during the procedure and at discharge. In total, 223 patients (244 lesions) were included in the analysis (106, 97, and 20 patientswith TIMI-Flow 0/1, TIMI-Flow 2/3, and cardiogenic shock, respectively). The overall mean age was 63 ± 12 years, 70% men and 38% with diabetes mellitus. Acute myocardial infarction was the main presentation (72%). The use of cangrelor improved TIMI-Flow, MGB, TMPG, and TIMI-Thrombus in patients with initial TIMI-Flow 0 to 2. Major bleeding rate was 2.0%. In conclusion, cangrelor was effective and safe in restoring TIMI-Flow 3, reducing thrombus burden and improving myocardial blush grade and TMPG when administered to unselected subjects who underwent PCI. Therefore, cangrelor should be considered in patients presenting with intracoronary thrombus before intervention.

Relation of Sex and Race to Outcomes in Patients Undergoing Percutaneous Intervention With Drug-Eluting Stents.

Cardiovascular disease is the leading cause of death in men and women, black and white. However, there exists limited outcomes data for women and blacks after percutaneous coronary intervention (PCI). The aim of this study was to evaluate the 1-year major cardiovascular events in patients who underwent PCI based on gender and race. We retrospectively analyzed data that were prospectively collected over 13 years at a large tertiary hospital in the United States. There were 12,050 patients who underwent PCI for both stable disease and acute coronary syndrome from 2003 to 2016. Of those, 1,952 were black men, 6,013 white men, 1,619 black women, and 2,466 white women. Major cardiovascular events at 1 year were assessed, and proportional Cox hazard model analyses were performed to assess outcome adjusted for confounding factors (i.e., age, body mass index, presentation with acute myocardial infarction, diabetes, smoking, history of coronary artery disease, family history of coronary artery disease, hyperlipidemia, hypertension, previous cardiovascular intervention, and chronic kidney disease). At 1 year, white men had significantly lower major cardiovascular events driven by lower rate of death compared with the other groups. Adjusted for confounders, major cardiovascular events were 1.3 to 1.5 times more likely to occur in black men and women and white women than in white men. There was a significant race by gender interaction (p <0.001).

Coronary perfusion pressure and left ventricular hemodynamics as predictors of cardiovascular collapse following percutaneous coronary intervention.

BACKGROUND/PURPOSE: Appropriate patient selection for mechanical circulatory support following percutaneous coronary intervention (PCI) remains a challenge. This study aims to evaluate the role of coronary perfusion pressure and other left ventricular hemodynamics to predict cardiovascular collapse following PCI. METHODS/MATERIALS: We retrospectively analyzed all patients who underwent PCI for acute coronary syndrome (ACS) from 2003 to 2016. Coronary perfusion pressure was calculated for each patient and defined as the difference in mean arterial pressure and left ventricular end diastolic pressure (LVEDP). Logistic regression analysis was performed to determine predictor of composite outcome of in-hospital mortality, myocardial infarction (MI), congestive heart failure (CHF), and cardiogenic shock. RESULTS: Nine hundred twenty-two patients were analyzed. Two-hundred twenty-eight (25%) presented with ST-elevation MI (STEMI) while 694 (75%) underwent PCI for unstable angina or non-Q-wave MI. The mean LVEDP was significantly higher in the STEMI patients (24 ±â€¯9 vs. 19 ±â€¯8 mm Hg, p < 0.05) and perfusion pressure significantly lower (68 ±â€¯24 vs. 74 ±â€¯18 mm Hg, p < 0.05). Eighty-seven (9.4%) reached the composite endpoint, and there was no difference between the STEMI and Not-STEMI groups. Neither LVEDP nor coronary perfusion pressure was a predictor of the composite outcome following multivariable logistic regression analysis for either STEMI or Not-STEMI patients. Increasing age, chronic renal insufficiency (CRI), CHF, and low left ventricular ejection fraction were predictors of the composite outcome for Not-STEMI patients, whereas only history of cerebrovascular accident and CRI were predictors for STEMI patients. CONCLUSIONS: In hemodynamically stable patients presenting with ACS, LVEDP and coronary perfusion pressure are not predictive of in-hospital cardiovascular collapse. SUMMARY: The authors retrospectively analyzed 922 patients from a single center who underwent percutaneous coronary intervention (PCI) for acute coronary syndromes to evaluate the role of coronary perfusion pressure and other left ventricular hemodynamics to predict cardiovascular collapse following PCI. They found that neither coronary perfusion pressure nor left ventricular end diastolic pressure was predictive of in-hospital cardiovascular collapse.

Emergent valve-in-valve transcatheter aortic valve replacement in patient with acute aortic regurgitation and cardiogenic shock with preoperative extracorporeal membrane oxygenator: A case report and review of the literature.

We describe a challenging case of successful use of emergent veno-arterial extracorporeal membrane oxygenation and valve-in-valve transcatheter aortic valve implantation with a Sapien S3 valve.

Meta-Analysis of the Impact of Strut Thickness on Outcomes in Patients With Drug-Eluting Stents in a Coronary Artery.

The aim of this network meta-analysis is to assess the impact of strut thickness on clinical outcomes in patients who underwent percutaneous coronary intervention. We searched Medline/PubMed and performed a Bayesian network meta-analysis to compare outcomes of patients who underwent percutaneous coronary intervention with drug-eluting stents (DES) of different strut thicknesses (ultrathin 60 to 80 µm; thin 81 to 100 µm; intermediate 101 to 120 µm; thick ≥120 µm). Studies comparing DES with similar strut thickness, bare metal stents, and fully bioresorbable scaffolds were excluded. Odds ratios with credible intervals (OR [CrIs]) were generated with random-effects models to compare outcomes. Our primary end point was stent thrombosis (ST). We identified 69 RCTs including 80,885 patients (ultrathin group = 10,219; thin group = 36,575; intermediate group = 11,399; thick group = 22,692). Mean age was 64 ± 11 years and 75% were male gender. When compared with thick-strut DES, ultrathin struts had significant less ST and myocardial infarction (OR 0.43 [CrI 0.27 to 0.68]; and OR 0.73 [CrI 0.62 to 0.92], respectively). Sensitivity analysis including only studies with permanent polymer DES gave similar results. Improvement in DES technology with thinner struts is associated with significant reduction in ST and myocardial infarction compared with thicker struts.