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BACKGROUND: Compared with everolimus-eluting metallic stents, the Absorb bioresorbable scaffold (BRS) results in increased rates of myocardial infarction (MI) and scaffold thrombosis (ST) during its three-year bioresorption phase. It is unknown whether prolonged dual antiplatelet therapy (DAPT) duration might decrease the risk of ischaemic events. AIMS: We sought to evaluate the impact of DAPT duration on ischaemic and bleeding outcomes following BRS implantation. METHODS: We conducted an individual patient data pooled analysis from four ABSORB randomised trials and one prospective ABSORB registry. Study endpoints were MI, ST, bleeding, and death up to three-year follow-up. Propensity score-adjusted Cox regression analysis was used to account for baseline differences related to DAPT duration. RESULTS: The five ABSORB studies included 2,973 patients. DAPT use was 91.7%, 53.2%, and 48.0% at 1, 2, and 3 years, respectively. DAPT use within the first year after BRS implantation was associated with markedly lower risks of MI (adjusted hazard ratio [aHR] 0.17, 95% CI: 0.10-0.32; p

Background The long-term prognostic impact of IVUS findings following Absorb BVS implantation remains uncertain. This study aimed to identify the IVUS predictors of long-term clinical outcomes following ABSORB bioresorbable vascular scaffold (BVS) implantation from the pooled IVUS substudy cohorts of the ABSORB III and Japan trials. Methods A total of 298 lesions in 286 patients were enrolled with 2:1 randomization to ABSORB BVS vs. cobalt-chromium everolimus-eluting stents. This sub-analysis included 168 lesions of 160 patients in the Absorb arm whose post-procedural quantitative IVUS were available. The primary endpoint of this analysis was device-oriented composite endpoint (DOCE) of target lesion failure, including cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization. The median follow-up duration was 4.9 [3.1–5.0] years. Results During follow-up, DOCE occurred in 10.1% of lesions treated with Absorb BVS. Among several post-procedural IVUS indices associated with DOCE, non-uniform device expansion (defined as uniformity index = minimum / maximum device area) (hazard ratio 0.47 per 0.1 increase [95%CI 0.28 to 0.77]; p = 0.003) and residual reference plaque burden (hazard ratio 4.01 per 10% increase [95%CI 1.50 to 10.77]; p = 0.006) were identified as independent predictors of DOCE by Cox multivariable analysis. Conclusions Nonuniform device expansion and substantial untreated residual plaque in reference segments were associated with long-term adverse events following BVS implantation. Baseline imaging to identify the appropriate device landing zone and procedural imaging to achieve uniform device expansion if possible (e.g. through post-dilatation) may improve clinical outcomes of BVS implantation. Clinical trial registration URL: http://www.clinicaltrials.gov . Unique identifier: NCT01751906 (ABSORB III); NCT01844284 (ABSORB Japan).

Guidelines suggest differential management of diabetics and nondiabetics with coronary artery disease (CAD) referred for revascularization, but pre-diabetics, who now comprise up to 20% to 30% of CAD patients, have been excluded from the diabetic group. To address this, we studied long-term cardiac outcomes in 1,323 consecutively drug-eluting stent (DES)-stented patients from prespecified local zip codes, dividing patients into normal-glycemic patients, prediabetics and diabetics, based upon conventional definitions. Patient age was 63±11 years, 65.5% male, mean baseline SYNTAX score of 10.2±6.8 and residual SYNTAX score=3.0±4.6. Only 2.9% of patients were lost to follow up at 10 years. Duration of follow up for alive patients was 124±33 mos. Major adverse cardiac events (MACE) by Kaplan Meier (KM) was similar for normal glycemics and prediabetics (42.9±2.5% vs 38.6±3.1% at 10 years, p=0.35), whereas that for diabetics was worse (56.7±2.6% at 10 years, p

Objectives The objective of this study is to identify and model risk factors for major adverse cardiac events (MACE) and all-cause mortality among patients with ESRD treated with PCI using DES. Background Patients with end-stage renal disease (ESRD) have poor long-term outcomes after percutaneous coronary intervention (PCI) compared with non-ESRD patients. However, there is a paucity of literature regarding risk factors associated with outcomes of ESRD patients after PCI with drug-eluding stents (DES). Methods This retrospective cohort study includes all patients with ESRD who underwent first-time PCI with DES at a single, high-volume hospital between 1/1/2005 and 12/31/2015, with follow-up through 9/1/2019. Primary outcomes were MACE (cardiac death, myocardial infarction, or unplanned revascularization) and all-cause mortality. Results Five-year MACE was 83.0% and five-year morality was 77.9% in patients with ESRD (n = 285). Among ESRD patients, factors independently associated with MACE were C-reactive peptide level, SYNTAX score, peripheral vascular occlusive disease, hemoglobin, and treatment of a restenotic lesion (c-index = 0.66). Factors independently associated with mortality in ESRD patients were age, SYNTAX score, non-use of statins at baseline, insulin-dependent diabetes, chronic obstructive pulmonary disease (COPD), peripheral vascular occlusive disease, and platelet count (c-index = 0.65). Conclusions Despite relatively poor 1-and 5-year outcomes among ESRD patients after PCI, risk of MACE and mortality among this cohort can be successfully modelled, which meaningfully informs clinicians regarding management of ESRD patients with coronary artery disease (CAD). Further investigations are necessary to determine whether or not outcomes might be improved through risk profile modification.

Excimer laser coronary atherectomy (ELCA) during percutaneous coronary intervention (PCI) has been in use for more than twenty years. While early experiences were not favorable over balloon angioplasty alone, with improvement in operator technique, patient selection and technology, ELCA has established its own niche in contemporary PCI as a safe and effective atherectomy strategy. With growing experience in complex coronary interventions worldwide, ELCA has become one of the essential atherectomy tools offering unique advantages over other atherectomy devices. In the modern era, ELCA is commonly used for patients with in-stent restenosis, stent under expansion, balloon uncrossable lesions and chronic total occlusions. Technical success rates are reported to be >80% in most situations while procedural complication rates such as vessel dissection and perforation among others are reported to average 9% over the past 25 years with improvement over time. In this review, we provide a comprehensive systematic review of the ELCA system, its practical use, indications, and procedural techniques in the contemporary PCI era.

Mortality in patients with STEMI-associated cardiogenic shock (CS) is increasing. Whether a comprehensive ST-elevation myocardial infarction (STEMI) protocol (CSP) can improve their care delivery and mortality is unknown. We evaluated the impact of a CSP on incidence and outcomes in patients with STEMI-associated CS. We implemented a 4-step CSP including: (1) Emergency Department catheterization lab activation; (2) STEMI Safe Handoff Checklist; (3) immediate catheterization lab transfer; (4) and radial-first percutaneous coronary intervention (PCI). We studied 1,272 consecutive STEMI patients who underwent PCI and assessed for CS incidence per National Cardiovascular Data Registry definitions within 24-hours of PCI, care delivery, and mortality before (January 1, 2011, to July 14, 2014; n = 723) and after (July 15, 2014, to December 31, 2016; n = 549) CSP implementation. Following CSP implementation, CS incidence was reduced (13.0% vs 7.8%, p = 0.003). Of 137 CS patients, 43 (31.4%) were in the CSP group. CSP patients had greater IABP-Shock II risk scores (1.9 ± 1.8 vs 2.8 ± 2.2, p = 0.014) with otherwise similar hemodynamic and baseline characteristics, cardiac arrest incidence, and mechanical circulatory support use. Administration of guideline-directed medical therapy was similar (89.4% vs 97.7%, p = 0.172) with significant improvements in trans-radial PCI (9.6% vs 44.2%, p < 0.001) and door-to-balloon time (129.0 [89:160] vs 95.0 [81:116] minutes, p = 0.001) in the CSP group, translating to improvements in infarct size (CK-MB 220.9 ± 156.0 vs 151.5 ± 98.5 ng/ml, p = 0.005), ejection fraction (40.8 ± 14.5% vs 46.7 ± 14.6%, p = 0.037), and in-hospital mortality (30.9% vs 14.0%, p = 0.037). In conclusion, CSP implementation was associated with improvements in CS incidence, infarct size, ejection fraction, and in-hospital mortality in patients with STEMI-associated CS. This strategy offers a potential solution to bridging the historically elusive gap in their care.

Although it is well established that adding early revascularization to optimal medical therapy reduces mortality and recurrent myocardial infarction in acute coronary syndrome, there is less convincing evidence to guide intervention in stable ischemic heart disease. This review summarizes the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) trial, which investigated whether there is benefit from initial catheterization and possible revascularization in addition to optimal medical therapy in patients with at least moderate ischemia on stress testing.

OBJECTIVES We sought to compare in-hospital outcomes between patients with and without end-stage renal disease (ESRD) undergoing coronary drug-eluting stent (DES) placement and to model risk of in-hospital adverse postpercutaneous coronary intervention (PCI) events in ESRD patients. BACKGROUND The effect of ESRD on the risk of in-hospital complications after DES PCI is relatively unclear, as is the ability to prospectively stratify risk in this population. METHODS Consecutive patients undergoing first-time DES between April 1, 2003 and June 30, 2018 at a single tertiary care hospital were included in a prospective registry. Outcomes in those with ESRD were compared to those without ESRD. The primary endpoint was in-hospital all-cause mortality; secondary endpoints included in-hospital major adverse cardiac events (MACE)-defined as cardiac death, myocardial infarction, or unplanned revascularization-and major bleeding. Multivariate logistic regression modeling was used to identify factors associated with each outcome and to generate risk scores. RESULTS Among 18,134 patients in the study population, 382 (2.1%) had ESRD. ESRD was associated with increased risk of in-hospital mortality (7.1 vs. 2.9%, p

Intracoronary stent restenosis (ISR) is a clinically relevant challenge in the modern era. Heterogeneity in patient- and lesion-specific factors can further compound this clinical challenge. Coronary intravascular brachytherapy (IVBT) was the standard therapeutic approach for ISR prior to the advent of drug-eluting stents (DES). Despite prospective data describing the superiority of DES over IVBT for treating de novo ISR, IVBT remains a treatment option for patients with complex disease. The purpose of this review is to evaluate the historical and contemporary literature surrounding IVBT in order to elucidate its role in modern cardiac care and to describe opportunities for future investigations to improve patient selection. Herein, we provide a review of the contemporary literature describing IVBT as a safe and effective treatment option for patients with recurrent, refractory ISR after multilayer DES and no good surgical or mechanical option. Combination therapy with emerging technologies such as DCBs may further increase efficacy.

Introduction: Radiation reduction measures were incorporated in the Cleveland Clinic Catheterization laboratories to mitigate the hazards from radiation exposure to patients and personnel during diagnostic and interventional coronary procedures. We report our experience with these improved systems over a 10-year period. Methods: Fluoroscopes were modified in 2013 by reducing the default fluoroscopic pulse rate from 10 to 7.5 pules/s, added default low-dose acquisitions, revised field-of-view dose factors, and instructed operators to use larger fields-of-view with appropriate collimation. A retrospective data analysis of all patients undergoing diagnostic catheterization from 2009 to 2012 (pre-initiative group), and 2013 to 2019 (post-initiative group) was done using Siemens CARE analytics software. The effectiveness of radiation reduction measures was assessed by comparing the total air kerma (K a,r ), and fluoroscopy- and acquisition-mode air kerma in patients in the two groups after propensity matching them based on age, sex, BSA, and total fluoroscopic time. Results: The total fluoroscopic time for the pre-initiative group (N=18,181) was 8.02 seconds while that for the post-initiative group (N=25,868) was 8.05 seconds. After matching 18,181 patients in both the groups (mean age, 64 years; 62% males), a significant reduction (54.4%) in the mean K a,r was observed in the post- in comparison to the pre-initiative group (420.94 mGy vs. 921.21 mGy; p-16 ). Further analysis revealed a reduction in the mean acquisition- (59.3%; 217.33 mGy vs. 533.50 mGy; p-16 ) and fluoroscopy-mode (47.5%; 203.61 mGy vs. 387.71 mGy; p-16 ) air kerma in the post-initiative group. A sub-analysis of patients matched on the basis of their exact fluoroscopy and acquisition times also revealed a significant reduction in K a,r , acquisition- and fluoroscopy-mode air kerma in the post-initiative group relative to the pre-initiative group (43.95%, 44.04%, 43.78% respectively). Conclusions: Optimization of imaging systems can significantly reduce patient radiation exposures which directly affect the radiation exposure of the Cath lab personnel. Similar algorithms can be applied in other labs to achieve a reduction in radiation exposure.

In stable coronary artery disease (CAD), revascularization improves outcomes only for patients with high-risk coronary anatomy (HRCA). We sought to derive and validate a prediction model, incorporating clinical and exercise stress test characteristics, to identify patients with HRCA. We conducted a retrospective analysis of patients undergoing exercise stress testing at Cleveland Clinic (2005 to 2014), followed by invasive coronary angiography within 3 months. We excluded patients with acute coronary syndrome, known CAD or ejection fraction50%. HRCA was defined as left main, 3-vessel, or 2-vessel disease involving the proximal left anterior descending artery. Clinical and stress test predictors of HRCA were identified in a multivariable logistic regression model, internally validated with 1,000-fold bootstrapping. The model was then externally validated at the University of Pittsburgh Medical Center (2017 to 2019). The model was derived from 2,758 patients with complete data. HRCA was identified in 418 patients (15.2%) in the derivation cohort. The model consisted of 10 variables: age, male gender, hypertension, hypercholesterolemia, diabetes mellitus, family history of premature CAD, high-density lipoprotein, chest pain, exercise time, and Duke Treadmill Score. Bias-corrected c-statistic was 0.79 (95% confidence interval 0.77 to 0.81) with excellent calibration. In all, 762 patients (27.6%) had a predicted probability and observed prevalence of HRCA5%. In the validation cohort, the model had a c-statistic of 0.79 (95% confidence interval 0.74 to 0.85) and 210 patients had an observed prevalence of HRCA5% (40%). In conclusion, an externally validated prediction model, based on clinical characteristics and exercise stress test variables, can identify stable patients with CAD who have HRCA.

Aims To determine whether a comprehensive ST-elevation myocardial infarction (STEMI) protocol is associated with reduced sex disparities over 5 years. Methods and results This was an observational cohort study of 1833 consecutive STEMI patients treated with percutaneous coronary intervention (PCI) before (1 January 2011–14 July 2014, control group) and after (15 July 2014–15 July 2019, protocol group) implementation of a protocol for early guideline-directed medical therapy (GDMT), rapid door to balloon time (D2BT), and use of trans-radial PCI. In the control group, females had less GDMT (77.1% vs. 68.1%, P = 0.03), similarly low trans-radial PCI (19.0% vs. 17.6%, P = 0.73), and longer D2BT [104 min (79, 133) vs. 112 min (85, 147), P = 0.02] corresponding to higher in-hospital mortality [4.5% vs. 10.3%, odds ratio (OR) 2.44 (1.34–4.46), P = 0.004], major adverse cardiac and cerebrovascular events [MACCE, 9.8% vs. 16.3%, OR 1.79 (1.14–2.84), P = 0.01], and net adverse clinical events [NACE, 16.1% vs. 28.3%, OR 2.06 (1.42–2.99), P < 0.001]. In the protocol group, no significant sex differences were observed in GDMT (87.2% vs. 86.4%, P = 0.81) or D2BT [85 min (64–106) vs. 89 min (65–111), P = 0.06], but trans-radial PCI was used less in females (77.6% vs. 71.2%, P = 0.03). In-hospital mortality [2.5% vs. 4.4%, OR 1.78 (0.91–3.51), P = 0.09] and MACCE [9.0% vs. 11.1%, OR 1.27 (0.83–1.92), P = 0.26] were similar between sexes, but higher NACE in females approached significance [14.8% vs. 19.4%, OR 1.38 (0.99–1.92), P = 0.05] due to higher bleeding risk [7.2% vs. 11.1%, OR 1.60 (1.04–2.46), P = 0.03]. Conclusions A comprehensive STEMI protocol was associated with sustained reductions for in-hospital ischaemic outcomes over 5 years, but higher bleeding rates in females persisted.

BackgroundLong‐term outcomes of percutaneous coronary intervention (PCI) based on patients’ decision‐making ability have not been studied. Our objective was to assess long‐term outcomes after PCI in patients who provided individual versus surrogate consent.Methods and ResultsData were collected retrospectively for patients who underwent PCI at Cleveland Clinic between January 1, 2015 and December 31, 2016. Inclusion criteria consisted of hospitalized patients aged ≥20 years who had PCI. Patients with outpatient PCI, or major surgery 30 days before or 90 days after PCI, were excluded. Patients who underwent PCI with surrogate consent versus individual consent were matched using the propensity analysis. Kaplan–Meier, log rank,t‐statistic, and χ2tests were used for statistical analysis. The study was approved by the Institutional Review Board at Cleveland Clinic, Ohio. Of 3136 patients who underwent PCI during the study period, 183 had surrogate consent. Propensity matching yielded 149 patients from each group. Two‐year all‐cause mortality was significantly higher in the surrogate consent group (38 [25.5%] versus 16 [10.7%] deaths, log‐rankχ2=10.16,Pχ2=8.36,P=0.003).ConclusionsPatients with surrogate consent had significantly higher all‐cause mortality and higher major adverse cardiac events when compared with patients with individual consent. This study emphasizes the fact that patients with an inability to give consent are at high risk and may need special attention in postprocedural and postdischarge care.

Background: The Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support similar to those of metallic drug-eluting stents, followed by complete resorption in ≈3 years with recovery of vascular structure and function. The ABSORB III trial demonstrated noninferior rates of target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year with BVS compared with cobalt chromium everolimus-eluting stents. Between 1 and 3 years and cumulative to 3 years, adverse event rates (particularly target vessel myocardial infarction and scaffold thrombosis) were increased after BVS. We sought to assess clinical outcomes after BVS through 5 years, including beyond the 3-year time point of complete scaffold resorption. Methods: Clinical outcomes from ABSORB III were analyzed by randomized device (intention to treat) cumulative to 5 years and between 3 and 5 years. Results: Rates of target lesion failure, target vessel myocardial infarction, and scaffold thrombosis were increased through the 5-year follow-up with BVS compared with everolimus-eluting stents. However, between 3 and 5 years, reductions in the relative hazards of the BVS compared with everolimus-eluting stents were observed, particularly for target lesion failure (hazard ratio, 0.83 [95% CI, 0.55–1.24] versus 1.35 [95% CI, 1.02–1.78]; P int =0.052) and scaffold thrombosis (hazard ratio, 0.26 [95% CI, 0.02–2.87] versus 3.23 [95% CI, 1.25–8.30]; P int =0.056) compared with the 0- to 3-year time period. Conclusions: In the ABSORB III trial, cumulative 5-year adverse event rates were increased after BVS compared with everolimus-eluting stents. However, the period of excess risk for BVS ended at 3 years, coincident with complete scaffold resorption. Clinical Trial Registration: URL: https://clinicaltrials.gov . Unique identifier: NCT01751906.

Management of ST-elevation myocardial infarction complicated by cardiogenic shock (STEMI-CS) has evolved in the last decade. There is paucity of data on readmissions in this study population. We aimed to assess the burden, major etiologies, and resource utilization for 30-day readmissions among patients with STEMI and CS. The Nationwide Readmission Database was queried from 2010 to 2014. All adult patients with an index admission for STEMI-CS were identified using International Classification of Diseases, ninth edition codes. Patient with mortality on index admission and transfers to other hospitals were excluded. A total of 18,659 admissions were identified with primary diagnosis of STEMI-CS for the study duration. Percutaneous coronary interventions was performed in 78.1% and mechanical circulatory devices were utilized in 53.9% with a mean length of stay of 10.6 (±0.2) days and mean cost of hospitalization of $47,744 (±327). Among these, 2,404 (12.9%) patients were readmitted within 30 days. Major etiologies for readmission include congestive heart failure (25.7%), acute myocardial infarction (9.4%), arrhythmias (4.5%), and sepsis (4.2%). The mean length of stay and cost of hospitalization for 30-day readmission were 5.9 (±0.3) days and $17,043 (±590), respectively. Older age, female gender, lower socioeconomic status, and discharge to home health care were significant predictors for readmission. In conclusion, there is a significant burden of 30-day readmission among patients with STEMI-CS. Percutaneous coronary interventions and mechanical circulatory devices were utilized in a majority of index admissions. Congestive heart failure was the single most common reason for 30-day readmission. Patients discharged to skilled nursing facility, patients with private insurance and higher socioeconomic status were less likely to be readmitted. Moreover, readmissions among STEMI-CS patients contribute to significant resource utilization.

Patients of different racial backgrounds may have socioeconomic, cultural, or genetic differences that impact outcomes after percutaneous coronary intervention (PCI). There are limited data beyond 2 to 3 years for Blacks to inform discussions and perhaps improve outcomes. We studied consecutive limus-stent treated patients, having their first PCI at our institution January 2003 to March 2010 in 2 cohorts; Cohort 1: standard 3-year follow-up (n = 3,782, 12.4% Blacks) and Cohort 2: from nearby zip codes with intended detailed follow-up through 8 to 13 years (n = 616, 31.8% Blacks). The primary outcomes of interest were mortality and death/MI/revascularization (DMIR) (Cohort 1) or major adverse cardiac events (cardiac DMIR) (Cohort 2). In all cohorts, Blacks had a higher prevalence of many risk factors. In Cohort 1, 3-year mortalities were 14.6% and 9.6% (p = 0.001) and DMIR were 32.1% and 25.0% (p = 0.001), for Blacks and Whites, respectively. In Cohort 2, over 9.5 ± 2.0 years, treatment intensity was as high or higher for Blacks, but they continued to have higher low-density lipoprotein-cholesterol and blood pressure values. Major adverse cardiac events and mortality at 10 years were higher for Blacks (59.0% vs 48.1%, p = 0.024 and 44.3% vs 23.0%, p0.001). Differences in outcomes, except 10 year mortality, were not significantly different after adjustment for baseline characteristics. Blacks have a higher risk profile at the time of PCI and worse long-term outcomes after drug-eluting stent, most of which is explained by baseline differences.

OBJECTIVES This study aimed to evaluate the incidence, treatment, and outcomes of acute myocardial infarction (AMI) following transcatheter or surgical aortic valve replacement (TAVR or SAVR). BACKGROUND Coronary artery disease is common in patients who undergo aortic valve replacement. However, little is known about differences in clinical features of post-TAVR or post-SAVR AMI. METHODS We retrospectively identified post-TAVR or post-SAVR (including isolated and complex SAVR) patients admitted with AMI using the Nationwide Readmissions Database 2012-2017. Incidence, invasive strategy (coronary angiography or revascularization), and in-hospital outcomes were compared between post-TAVR and post-SAVR AMIs. RESULTS The incidence of 180-day AMI was higher post-TAVR than post-SAVR (1.59% vs. 0.72%; p

Background: To risk stratify patients undergoing single-photon emission computed tomography myocardial perfusion imaging (SPECT-MPI) in accordance with appropriate use criteria for referral to coronary angiography, we developed a risk classification algorithm incorporating appropriate use criteria–defined risk features. We evaluated the association between this algorithm with downstream angiography, revascularization, and all-cause mortality. Methods: We studied consecutive patients who underwent SPECT-MPI from January 1, 2015, to December 31, 2017, and assigned a scan risk of low, intermediate, high, or indeterminate. With this stratification, we assessed referral for angiography and revascularization within 3 months of SPECT-MPI and intermediate-term mortality. Results: Among 12 799 patients, the mean age was 66 years, and a majority were men (56.8%). Most patients were low risk (83.6%) followed by intermediate (9.9%) and high risk (5.2%). Compared with low-risk patients, intermediate- and high-risk patients were more frequently referred for angiography (14.8% and 13.6% versus 2.0%; P P P P =0.008) and high scan risk (hazard ratio, 1.98 [95% CI, 1.53–2.56]; P Conclusions: This appropriate use criteria–derived risk classification algorithm for SPECT-MPI guided referral for coronary angiography and revascularization and was significantly associated with mortality. This algorithm may serve as an important tool to reaffirm appropriate use criteria and direct management of patients with stable ischemic heart disease undergoing stress testing.

Coronavirus disease 2019 (COVID-19) causes significant morbidity and mortality for a proportion of infected patients, and our knowledge and understanding of its clinical, radiological and histopathological features are still evolving. An association between COVID-19 and pneumothorax has been described in an increasing number of case reports and series in the literature, which have largely focused on clinical and imaging features. We report the case of a patient who developed COVID-19 complicated by pneumothorax, requiring surgical intervention. We describe the histopathological features seen in the thorascopically resected bullectomy specimen-this is, to our knowledge, the first reported description of the morphological features of pneumothorax in this important clinical setting.

Background: Although most drug-eluding stent (DES) patients live longer than 10 years, there is no generally accepted clinical tool to predict risk of major adverse cardiac events (MACE) after DES over that period of time. Methods: Local consecutive patients receiving their first limus-eluting DES from 6/04-6/12 were characterized at baseline and prospectively followed. Patients were randomly allocated to a training or validation cohort, and a predictive Cox model using pre-procedural variables was developed in the training set. This model was then retested in a validation cohort. The primary endpoint was the c-index in the validation cohort. CIF and Fine-Gray were used for sensitivity analysis. Results: Patients (n=1321) had mean follow up of 10±3 years (3% were lost to follow up). Baseline characteristics included age=63±11 years, 65% male, SYNTAX Score=10±7, 1st/2nd Gen DES (%)=42.8/57.2, DES length (mm)=33±22. In the training set, MACE was independently correlated with renal insufficiency (p Conclusions: Ten year risk of MACE can be accurately modeled using this simple model, with risk ranging from about 30% to nearly 100%.

Background We sought to determine (1) long‐term outcomes in patients presenting with documented Takotsubo syndrome (TS), (2) whether left ventricular global longitudinal strain (LV‐GLS) provides incremental prognostic value, and (3) prognostic cutoffs of LV ejection fraction (LVEF) and LV‐GLS during an acute TS episode. Methods and Results We studied 650 patients with TS (aged 66±14 years, 88% women) who were diagnosed clinically and angiographically between 2006 and 2018. Baseline LVEF and LV‐GLS (using velocity vector imaging) were recorded. The primary end point was all‐cause mortality. TS triggers were unknown (34%), emotional (16%), physical (41%), and neurologic (10%). Mean LVEF and LV‐GLS were 36±10% and −11.6±0.4%; in addition, 94% patients had LVEF P P P Conclusions Patients with TS with a neurologic or physical trigger had significantly worse survival than those without such a trigger, with baseline LVEF and LV‐GLS providing incremental prognostic value.

To investigate the impact of novel, polymer-jacketed, tapered-tip, low-force guidewires with composite-core, dual-coil design (Fielder XT-R and Fielder XT-A; Asahi Intecc) on antegrade wire escalation (AWE) crossing of coronary chronic total occlusion (CTO) lesions.From March of 2017 to December 2018, a total of 164 consecutive CTO lesions at a single institution were treated with a primary AWE strategy using either Fielder XT-R or XT-A (XTRA) as the starting wire regardless of lesion characteristics. Success rates, wiring times, and complications were analyzed.The mean Japanese (J)-CTO score was 3.71 ± 1.27, mean PROGRESS-CTO score was 2.46 ± 1.15, and mean PROGRESS-CTO Complications score was 3.9 ± 2.0. Mean CTO length was 25.0 ± 0.5 mm, 48 lesions (29.3%) were previously bypassed, 77 lesions (47.0%) had moderate to severe calcification, and 62 lesions (37.8%) had moderate to severe tortuosity. Antegrade success rates using XTRA wires were 79%, 60%, and 17% of lesions with J-CTO scores of 0-1, 2-3, and 4-5, respectively. In successful antegrade XTRA cases, median wiring times were 6.5 min (interquartile range [IQR], 5.0-11.0 min), 9.0 min (IQR, 4.2-14.0 min), and 12.0 min (IQR, 9.0-15.0 min) for J-CTO scores of 0-1, 2-3, and 4-5, respectively, and differed non-significantly according to J-CTO score (P=.20). Complication rates were low (In-hospital major adverse cardiac event rate, 1.3%) with no wire perforations caused by XTRA wires.Use of Fielder XTRA wires as part of an AWE strategy in CTO percutaneous coronary interventions may facilitate more efficient antegrade lesion crossing and overall procedural success in lesions that have been traditionally challenging to treat using an antegrade-first approach.

AIMS The Absorb bioresorbable vascular scaffold (BVS) has high rates of target lesion failure (TLF) at three years. Low wall shear stress (WSS) promotes several mechanisms related to device TLF. We investigated the impact of BVS compared to XIENCE V (XV) on coronary WSS after device deployment. METHODS AND RESULTS In the prospective, randomised, controlled ABSORB III Imaging study (BVS [n=77] or XV [n=36]), computational fluid dynamics were performed on fused angiographic and intravascular ultrasound (IVUS) images of post-implanted vessels. Low WSS was defined as

Background Early coronary ischemic events are uncommon after cardiac surgery, with little known about their management or associated outcomes. We evaluated clinical outcomes of patients undergoing coronary angiography ± percutaneous coronary intervention or redo coronary artery bypass grafting for suspected coronary ischemia within 3 weeks after index cardiac surgery. Methods This is a retrospective observational study based on data from 53,287 patients who underwent cardiac surgery at our institution (1996-2017); 180 patients (0.34%) satisfied the inclusion criteria. The primary outcome was 1-year all-cause mortality. Statistical evaluation involved χ2, analysis of variance, Kaplan-Meier, and receiver operating characteristic curve analyses. Results Most coronary angiography ± percutaneous coronary intervention and redo coronary artery bypass grafting procedures occurred in the first 2 weeks after index cardiac surgery. Patients presenting with ST elevation myocardial infarction (STEMI)/non-STEMI had the lowest 1-year mortality (13.5%), followed by patients with ventricular tachycardia/fibrillation (28.1%), and patients with non–ventricular tachycardia/fibrillation arrest or hemodynamic instability alone the worst (38.6%) (χ2 = 17.3, P = .001). Peak troponin T level after cardiac surgery was strongly predictive of 1-year mortality (area under the curve, 0.74; 95% confidence interval, 0.65-0.84; P Conclusions Although suspected myocardial ischemia requiring coronary angiography or intervention early after cardiac surgery was rare, mortality was high, particularly in presentations other than STEMI/non-STEMI. In patients with overt signs and symptoms of myocardial ischemia after index cardiac surgery, troponin T was not a reliable marker of underlying coronary or graft obstruction but was a robust predictor of 1-year mortality.

Summary Background Previous studies showed more adverse events with coronary bioresorbable vascular scaffolds (BVS) than with metallic drug-eluting stents (DES), although in one randomised trial angina was reduced with BVS. However, these early studies were unmasked, lesions smaller than intended for the scaffold were frequently enrolled, implantation technique was suboptimal, and patients with myocardial infarction, in whom BVS might be well suited, were excluded. Methods In the active-controlled, blinded, multicentre, randomised ABSORB IV trial, patients with stable coronary artery disease or acute coronary syndromes aged 18 years or older were recruited from 147 hospitals in five countries (the USA, Germany, Australia, Singapore, and Canada). Enrolled patients were randomly assigned (1:1) to receive polymeric everolimus-eluting BVS (Absorb; Abbott Vascular, Santa Clara, CA, USA) with optimised implantation technique or cobalt-chromium everolimus-eluting stents (EES; Xience; Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetic status, whether patients would have been eligible for enrolment in the previous ABSORB III trial, and site. Patients and clinical assessors were masked to randomisation. The primary endpoint was target lesion failure (cardiac death, target vessel myocardial infarction, or ischaemia-driven target lesion revascularisation) at 30 days, tested for non-inferiority with a 2·9% margin for the risk difference. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02173379, and is closed to accrual. Findings Between Aug 15, 2014, and March 31, 2017, we screened 18 722 patients for eligibility, 2604 of whom were enrolled. 1296 patients were assigned to BVS, and 1308 patients were assigned to EES. Follow-up data at 30 days and 1 year, respectively, were available for 1288 and 1254 patients with BVS and for 1303 and 1272 patients with EES. Biomarker-positive acute coronary syndromes were present in 622 (24%) of 2602 patients, and, by angiographic core laboratory analysis, 78 (3%) of 2893 of lesions were in very small vessels. Target lesion failure at 30 days occurred in 64 (5·0%) patients assigned to BVS and 48 (3·7%) patients assigned to EES (difference 1·3%, upper 97·5% confidence limit 2·89; one-sided p non-inferiority =0·0244). Target lesion failure at 1 year occurred in 98 (7·8%) patients assigned to BVS and 82 (6·4%) patients assigned to EES (difference 1·4%, upper 97·5% confidence limit 3·4; one-sided p non-inferiority =0·0006). Angina, adjudicated by a central events committee at 1 year, occurred in 270 (20·3%) patients assigned to BVS and 274 (20·5%) patients assigned to EES (difference −0·3%, 95% CI −3·4% to 2·9%; one-sided p non-inferiority =0·0008; two-sided p superiority =0·8603). Device thrombosis within 1 year occurred in nine (0·7%) patients assigned to BVS and four (0·3%) patients assigned to EES (p=0·1586). Interpretation Polymeric BVS implanted with optimised technique in an expanded patient population resulted in non-inferior 30-day and 1-year rates of target lesion failure and angina compared with metallic DES. Funding Abbott Vascular.

Objectives The aim of this study was to identify independent correlates of very late scaffold thrombosis (VLST) from an analysis of consecutively treated patients from 15 multicenter studies. Background Recent analyses suggest an increased risk for VLST with the Absorb Bioresorbable Vascular Scaffold compared with drug-eluting stents, but insights as to correlates of risk are limited. Methods A total of 55 patients were identified with scaffold thrombosis. They were matched 2:1 with control subjects selected randomly from patients without thrombosis from the same study. Quantitative coronary angiography was available for 96.4% of patients. Multiple logistic and Cox regression analysis were used to identify significant independent outcome correlates from 6 pre-specified characteristics. Results Patients had scaffold thrombosis at a median of 20 months (interquartile range: 17 to 27 months). Control subjects were followed for 36 months (interquartile range: 24 to 38 months). For the combined groups, reference vessel diameter (RVD) was 2.84 ± 0.50 mm, scaffold length was 26 ± 16 mm, and post-dilatation was performed in 56%. Univariate correlates of thrombosis were smaller nominal scaffold/RVD ratio (linear p = 0.001; ratio 2.72 mm; odds ratio: 3.4; p = 0.001). Post-dilatation at ≥16 atm, post-dilatation balloon/scaffold ratio, final percentage stenosis, and dual antiplatelet therapy were not correlated with VLST. Only scaffold/RVD ratio remained a significant independent correlate of VLST (p = 0.001), as smaller ratio was correlated with RVD (p Conclusions In the present analysis, the largest to date of its type, relative scaffold undersizing was the strongest determinant of VLST. Given current understanding of “scaffold dismantling,” this finding likely has ramifications for all bioresorbable scaffolds.

OBJECTIVES To determine if fractional flow reserve guided percutaneous coronary intervention (FFR-guided PCI) is associated with reduced ischemic myocardium compared with angiography-guided PCI. BACKGROUND Although FFR-guided PCI has been shown to improve outcomes, it remains unclear if it reduces the extent of ischemic myocardium at risk compared with angiography-guided PCI. METHODS We evaluated 380 patients (190 FFR-guided PCI cases and 190 propensity-matched controls) who underwent PCI from 2009 to 2014. Clinical, laboratory, angiographic, stress testing, and major adverse cardiac events [MACE] (all-cause mortality, recurrence of MI requiring PCI, stroke) data were collected. RESULTS Mean age was 63 ± 11 years; the majority of patients were males (76%) and Caucasian (77%). Median duration of follow up was 3.4 [Range: 1.9, 5.0] years. Procedural complications including coronary dissection (2% vs. 0%, P = .12) and perforation (0% vs. 0%, P = 1.00) were similar between FFR-guided and angiography-guided PCI patients. FFR-guided PCI patients had lower unadjusted (14.7% vs. 23.2%, P = .04) and adjusted [OR = 0.58 (95% CI: 0.34-0.98)] risk of repeat revascularization at one year. FFR-guided PCI patients were less likely (23% vs. 32%, P = .02) to have ischemia and had lower (5.9% vs. 21.1%, P

This study sought to report outcomes from an efficiency improvement project in a large cardiac cath lab.Operational inefficiencies are common in the cath lab, yet solutions are challenging. A detailed report describing and providing solutions for these inefficiencies may be valuable in guiding improvements in productivity.In this observational study, the authors report metrics of efficiency before and after a cath lab quality improvement program in June 2014. Main outcomes included lab room start times, room turnaround times, laboratory use, and employee satisfaction. Time series analysis was used to assess trend over time. Chi-square testing and analysis of variance were used to assess change before and after the initiative.The principal changes included implementation of a pyramidal nursing schedule, increased use of an electronic scheduling system, and increased utilization of a preparation and recovery area. Comparing before with after the program, start times improved an average of 17 min, and on-time starts improved from 61.8% to 81.7% (p = 0.0024). Turnaround times improved from 20.5 min to 16.4 min (trend p 0.0001), and the proportion of days at full lab utilization improved from 7.7% to 77.3% (p 0.00001). There were no increases in overtime, night, or weekend cases. There was a reduction in full time employees from 36.1 in 2013 to 29.6 in 2016, with an improvement in employee satisfaction.A systematic approach to reducing inefficiencies can improve cath lab start times, turnaround times, and overall productivity. This knowledge may be helpful in assisting other cath labs in similar efficiency improvement initiatives.

Background: The Absorb bioresorbable vascular scaffold (BVS) completely resorbs within 3 years after coronary artery implantation. The safety and effectiveness of BVS through this critical 3-year period have not been characterized. Methods: We performed an individual-patient-data pooled meta-analysis of the 4 randomized ABSORB trials in which 3389 patients with coronary artery disease were randomly assigned to everolimus-eluting Absorb BVS (n=2164) or cobalt-chromium everolimus-eluting stents (n=1225). The primary efficacy outcome measure was target lesion failure (cardiac mortality, target vessel myocardial infarction, or ischemia-driven target lesion revascularization), and the primary safety outcome measure was device thrombosis. Results: BVS compared with cobalt-chromium everolimus-eluting stents resulted in higher 3-year rates of target lesion failure (11.7% versus 8.1%; risk ratio [RR], 1.38; 95% confidence interval [CI], 1.10–1.73; P =0.006), driven by greater target vessel myocardial infarction (7.8% versus 4.2%; RR, 1.72; 95% CI, 1.26–2.35; P =0.0006) and ischemia-driven target lesion revascularization (6.6% versus 4.4%; RR, 1.44; 95% CI, 1.05–1.98; P =0.02), with comparable cardiac mortality (1.1% versus 1.1%; RR, 0.93; 95% CI, 0.47–1.88; P =0.85). Device thrombosis rates through 3 years were also higher with BVS (2.4% versus 0.6%; RR, 3.71; 95% CI, 1.70–8.11; P =0.001). Between 1 and 3 years, target lesion failure rates (6.1% versus 3.9%; P =0.02) and device thrombosis rates (1.1% versus 0.0%; P Conclusions: In the present individual-patient-data pooled meta-analysis of the ABSORB trials, BVS was associated with increased rates of target lesion failure and device thrombosis between 1 and 3 years and cumulatively through 3 years of follow-up compared with everolimus-eluting stents. Clinical Trial Registration: URL: https://clinicaltrials.gov . Unique identifiers: NCT01751906, NCT01844284, NCT01923740, and NCT01425281.

Background: Cardiac arrest (CA) complicating ST-elevation myocardial infarction (STEMI) is associated with a disproportionately higher risk of mortality. We described the contemporary presentation, management, and outcomes of CA patients in the era of primary percutaneous coronary intervention (PCI). Methods: We reviewed 1,272 consecutive STEMI patients who underwent PCI between 1/1/2011-12/31/2016 and compared characteristics and outcomes between non-CA (N = 1,124) and CA patients (N = 148), defined per NCDR definitions as pulseless arrest requiring cardiopulmonary resuscitation and/or defibrillation within 24-hr of PCI. Results: Male gender, cerebrovascular disease, chronic kidney disease, in-hospital STEMI, left main or left anterior descending culprit vessel, and initial TIMI 0 or 1 flow were independent predictors for CA. CA patients had longer door-to-balloon-time (106 [83,139] vs. 97 [74,121] minutes, p = 0.003) and greater incidence of cardiogenic shock (48.0% vs. 5.9%, p < 0.001), major bleeding (25.0% vs. 9.4%, p < 0.001), and 30-day mortality (16.2% vs. 4.1%, p < 0.001). Risk score for 30-day mortality based on presenting characteristics provided excellent prognostic accuracy (area under the curve = 0.902). However, over long-term follow-up of 4.5 ± 2.4 years among hospital survivors, CA did not portend any additional mortality risk (HR: 1.01, 95% CI: 0.56–1.82, p = 0.97). Conclusions: In a contemporary cohort of STEMI patients undergoing primary PCI, CA occurs in >10% of patients and is an important mechanism of mortality in patients with in-hospital STEMI. While CA is associated with adverse outcomes, it carries no additional risk of long-term mortality among survivors highlighting the need for strategies to improve the in-hospital care of STEMI patients with CA.

Significant progress has been made in the percutaneous coronary intervention technique from the days of balloon angioplasty to modern-day metallic drug-eluting stents (DES). Although metallic stents solve a temporary problem of acute recoil following balloon angioplasty, they leave behind a permanent problem implicated in very late events (in addition to neoatherosclerosis). BRS were developed as a potential solution to this permanent problem, but the promise of these devices has been tempered by clinical trials showing increased risk of safety outcomes, both early and late. This is not too dissimilar to the challenges seen with first-generation DES in which refinement of deployment technique, prolongation of dual antiplatelet therapy, and technical iteration mitigated excess risk of very late stent thrombosis, making DES the treatment of choice for coronary artery disease. This white paper discusses the factors potentially implicated in the excess risks, including the scaffold consideration and deployment technique, and outlines patient and lesion selection, implantation technique, and dual antiplatelet therapy considerations to potentially mitigate this excess risk with the first-generation thick strut Absorb scaffold (Abbott Vascular, Abbott Park, Illinois). It remains to be seen whether these considerations together with technical iterations will ultimately close the gap between scaffolds and metal stents for short-term events while at the same time preserving options for future revascularization once the scaffold bioresorbs.

Objectives The study sought to investigate the incidence, characteristics, predictors, and possible mechanisms of early and 3-year coronary scaffold thrombosis (ScT). Background An increased incidence of both early and late ScT has been shown in randomized trials. Methods Consecutive patients were enrolled in a single-center registry. Quantitative coronary angiography was performed. Incidence and predictors of ScT were assessed with Kaplan-Meier and Cox regression analyses. Results A total of 657 patients (63 ± 12 years of age, 79% men, 21% diabetic, 64% acute coronary syndrome) who received 925 coronary bioresorbable scaffolds (BRS) (Abbott Vascular, Santa Clara, California) between May 2012 and January 2015 were enrolled. Clinical and procedural characteristics and outcome data at 1,076 (interquartile range: 762 to 1,206) days (3-year follow-up rate 93%) were collected. Twenty-eight ScTs were recorded: 14 early (Kaplan-Meier estimate: 2.2%), 5 late (Kaplan-Meier estimate: 0.9%), and 9 very late (Kaplan-Meier estimate: 1.7%). The incidence of ScT followed a U-shaped curve with highest incidence at the extremes of the distributions of reference vessel diameter (RVD) and the ratio of BRS nominal diameter to RVD. At quantitative coronary angiography, RVD (hazard ratio [HR]: 0.14; 95% confidence interval [CI]: 0.04 to 0.49) and BRS oversizing (ratio of BRS nominal diameter to RVD >1.15; HR: 107.40; 95% CI: 9.20 to 1,261.30) emerged as potent predictors of early ScT. RVD (HR: 9.55; 95% CI: 3.90 to 23.42) and BRS undersizing (ratio of BRS nominal diameter to RVD Conclusions Different mechanisms underlie early and late ScT: although incomplete BRS deployment was a predictor of the former, the latter was associated with large vessel size and BRS undersizing. However, both phenomena are significantly less frequent with an optimized implantation technique. (Mainz Intracoronary Database. The Coronary Slow-flow and Microvascular Diseases Registry [MICAT]; NCT02180178)

Background The Absorb everolimus-eluting poly-L-lactic acid–based bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support functions similar to metallic drug-eluting stents (DES), followed by complete bioresorption in approximately 3 years with recovery of vascular structure and function. The ABSORB III trial demonstrated noninferior rates of target lesion failure (cardiac death, target vessel myocardial infarction [TVMI], or ischemia-driven target lesion revascularization) at 1 year in 2,008 patients with coronary artery disease randomized to BVS versus cobalt-chromium everolimus-eluting stents (EES). Objectives This study sought to assess clinical outcomes through 3 years following BVS implantation. Methods Clinical outcomes from the ABSORB III trial were analyzed by randomized treatment assignment cumulative through 3 years, and between 1 and 3 years. Results The primary composite endpoint of target lesion failure through 3 years occurred in 13.4% of BVS patients and 10.4% of EES patients (p = 0.06), and between 1 and 3 years in 7.0% versus 6.0% of patients, respectively (p = 0.39). TVMI through 3 years was increased with BVS (8.6% vs. 5.9%; p = 0.03), as was device thrombosis (2.3% vs. 0.7%; p = 0.01). In BVS-assigned patients, treatment of very small vessels (those with quantitatively determined reference vessel diameter Conclusions In the ABSORB III trial, 3-year adverse event rates were higher with BVS than EES, particularly TVMI and device thrombosis. Longer-term clinical follow-up is required to determine whether bioresorption of the polymeric scaffold will influence patient prognosis. (ABSORB III Randomized Controlled Trial [RCT] [ABSORB-III]; NCT01751906)