Hospital market concentration and the use of mechanical circulatory support devices in acute myocardial infarction complicated by cardiogenic shock.

BACKGROUND: As health care markets in the United States have become increasingly consolidated, the role of market concentration on physician treatment behavior remains unclear. In cardiology, specifically, there has been evolving treatment of acute myocardial infarction complicated by cardiogenic shock (AMI-CS) with increasing use of mechanical circulatory support (MCS). However, there remains wide variation in it use. The role of market concentration in the utilization of MCS in AMI-CS is unknown. We examined the use of MCS in AMI-CS and its effect on outcomes between competitive and concentrated markets. METHODS AND RESULTS: We used the National Inpatient Sample to query patients admitted with AMI-CS between 2003 and 2009. The primary study outcome was the use of mechanical circulatory support. The primary study exposure was market concentration, measured using the Herfindahl-Hirschman Index, which was used to classify markets as unconcentrated (competitive), moderately concentrated, and highly concentrated. Baseline characteristics, procedures, and outcomes were compared for patients in differently concentrated markets. Multivariable logistic regression was used to examine the association between HHI and use of MCS. RESULTS: There were 32,406 hospitalizations for patients admitted with AMI-CS. Patients in unconcentrated markets were more likely to receive MCS than in highly concentrated markets (unconcentrated 46.8% [5087/10,873], moderately concentrated 44.9% [2933/6526], and high concentrated 44.5% [6676/15,007], p < 0.01). Multivariable regression showed that patients in more concentrated markets had decreased use of MCS in patients in later years of the study period (2009, OR 0.64, 95% CI 0.44-0.94, p = 0.02), with no effect in earlier years. There was no significant difference in in-hospital mortality. CONCLUSION: Multivariable analysis did not show an association with market concentration and use of MCS in AMI-CS. However, subgroup analysis did show that competitive hospital markets were associated with more frequent use of MCS in AMI-CS as frequency of utilization increased over time. Further studies are needed to evaluate the effect of hospital market consolidation on the use of MCS and outcomes in AMI-CS.

Prognostically relevant periprocedural myocardial injury and infarction associated with percutaneous coronary interventions: a Consensus Document of the ESC Working Group on Cellular Biology of the Heart and European Association of Percutaneous Cardiovascular Interventions (EAPCI).

A substantial number of chronic coronary syndrome (CCS) patients undergoing percutaneous coronary intervention (PCI) experience periprocedural myocardial injury or infarction. Accurate diagnosis of these PCI-related complications is required to guide further management given that their occurrence may be associated with increased risk of major adverse cardiac events (MACE). Due to lack of scientific data, the cut-off thresholds of post-PCI cardiac troponin (cTn) elevation used for defining periprocedural myocardial injury and infarction, have been selected based on expert consensus opinions, and their prognostic relevance remains unclear. In this Consensus Document from the ESC Working Group on Cellular Biology of the Heart and European Association of Percutaneous Cardiovascular Interventions (EAPCI), we recommend, whenever possible, the measurement of baseline (pre-PCI) cTn and post-PCI cTn values in all CCS patients undergoing PCI. We confirm the prognostic relevance of the post-PCI cTn elevation >5× 99th percentile URL threshold used to define type 4a myocardial infarction (MI). In the absence of periprocedural angiographic flow-limiting complications or electrocardiogram (ECG) and imaging evidence of new myocardial ischaemia, we propose the same post-PCI cTn cut-off threshold (>5× 99th percentile URL) be used to define prognostically relevant 'major' periprocedural myocardial injury. As both type 4a MI and major periprocedural myocardial injury are strong independent predictors of all-cause mortality at 1 year post-PCI, they may be used as quality metrics and surrogate endpoints for clinical trials. Further research is needed to evaluate treatment strategies for reducing the risk of major periprocedural myocardial injury, type 4a MI, and MACE in CCS patients undergoing PCI.

Development and validation of a predictive model for bleeding after peripheral vascular intervention: A report from the National Cardiovascular Data Registry Peripheral Vascular Interventions Registry.

OBJECTIVES: To develop a model to predict risk of in-hospital bleeding following endovascular peripheral vascular intervention. BACKGROUND: Peri-procedural bleeding is a common, potentially preventable complication of catheter-based peripheral vascular procedures and is associated with increased mortality. We used the National Cardiovascular Data Registry (NCDR) Peripheral Vascular Interventions (PVI) Registry to develop a novel risk-prediction model to identify patients who may derive the greatest benefit from application of strategies to prevent bleeding. METHODS: We examined all patients undergoing lower extremity PVI at 76 NCDR PVI hospitals from 2014 to 2017. Patients with acute limb ischemia (n = 1600) were excluded. Major bleeding was defined as overt bleeding with a hemoglobin (Hb) drop of ≥ 3 g/dl, any Hb decline of ≥ 4 g/dl, or a blood transfusion in patients with pre-procedure Hb ≥ 8 g/dl. Hierarchical multivariable logistic regression was used to develop a risk model to predict major bleeding. Model validation was performed using 1000 bootstrapped replicates of the population after sampling with replacement. RESULTS: Among 25,382 eligible patients, 1017 (4.0%) developed major bleeding. Predictors of bleeding included age, female sex, critical limb ischemia, non-femoral access, prior heart failure, and pre-procedure hemoglobin. The model demonstrated good discrimination (optimism corrected c-statistic = 0.67), calibration (corrected slope = 0.98, intercept of -0.04) and range of predicted risk (1%-18%). CONCLUSIONS: Post-procedural PVI bleeding risk can be predicted based upon pre- and peri-procedural patient characteristics. Further studies are needed to determine whether this model can be utilized to improve procedural safety through developing and targeting bleeding avoidance strategies.

Impact of COVID-19 pandemic on STEMI care: An expanded analysis from the United States.

OBJECTIVE: To evaluate the impact of COVID-19 pandemic migitation measures on of ST-elevation myocardial infarction (STEMI) care. BACKGROUND: We previously reported a 38% decline in cardiac catheterization activations during the early phase of the COVID-19 pandemic mitigation measures. This study extends our early observations using a larger sample of STEMI programs representative of different US regions with the inclusion of more contemporary data. METHODS: Data from 18 hospitals or healthcare systems in the US from January 2019 to April 2020 were collecting including number activations for STEMI, the number of activations leading to angiography and primary percutaneous coronary intervention (PPCI), and average door to balloon (D2B) times. Two periods, January 2019-February 2020 and March-April 2020, were defined to represent periods before (BC) and after (AC) initiation of pandemic mitigation measures, respectively. A generalized estimating equations approach was used to estimate the change in response variables at AC from BC. RESULTS: Compared to BC, the AC period was characterized by a marked reduction in the number of activations for STEMI (29%, 95% CI:18-38, p < .001), number of activations leading to angiography (34%, 95% CI: 12-50, p = .005) and number of activations leading to PPCI (20%, 95% CI: 11-27, p < .001). A decline in STEMI activations drove the reductions in angiography and PPCI volumes. Relative to BC, the D2B times in the AC period increased on average by 20%, 95%CI (-0.2 to 44, p = .05). CONCLUSIONS: The COVID-19 Pandemic has adversely affected many aspects of STEMI care, including timely access to the cardiac catheterization laboratory for PPCI.

Hot topics in interventional cardiology: Proceedings from the society for cardiovascular angiography and interventions (SCAI) 2021 think tank.

The Society for Cardiovascular Angiography and Interventions (SCAI) Think Tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community annually for high-level field-wide discussions. The 2021 Think Tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease. Each session was moderated by a senior content expert and co-moderated by a member of SCAI's Emerging Leader Mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialog from a broader base, and thereby aid SCAI, the industry community and external stakeholders in developing specific action items to move these areas forward.

Cardiac implantable electronic device placement following alcohol septal ablation for hypertrophic cardiomyopathy in the United States.

BACKGROUND: Cardiac implantable electronic devices (CIED) are sometimes required after alcohol septal ablation (ASA) for hypertrophic cardiomyopathy (HCM). The primary objectives of this study were to characterize the incidence, timing, and predictors of CIED placement after ASA for HCM. METHODS: Patients were identified from the 2010-2015 Nationwide Readmissions Databases. Incidence, timing and independent predictors of CIED placement, as well as 30-day readmission rates were examined. RESULTS: There were 1296 patients (national estimate = 2864) with HCM who underwent ASA. CIED were implanted in 322 (25% overall; 14% permanent pacemaker, 11% implantable cardioverter defibrillator) during the index hospitalization. Of these, 21%, 23%, 21%, and 18% occurred on postprocedure day 0, 1, 2, and 3, respectively. Only 17 (1.3%) patients underwent CIED implantation between discharge and 30-day follow up. Independent predictors of index hospitalization CIED implantation included older age, diabetes, heart failure, nonelective index hospital admission and hospitalization at a privately owned hospital. Nonelective 30-day readmission rates among those who did and did not undergo CIED placement during their index hospitalization, were 6.8% and 7.9%, respectively (p = .53); median time to readmission was also similar between groups. CONCLUSIONS: One in four HCM patients undergoing ASA underwent CIED implantation during their index hospitalization; nearly 2/3rd during the first 48 h postprocedure. Private hospital ownership independently predicted CIED placement. More data are needed to better understand the unexpectedly high rates of CIED placement, earlier than anticipated timing of implantation and differential rates by hospital ownership.

SCAI expert consensus statement update on best practices for transradial angiography and intervention.

Transradial angiography and intervention continues to become increasingly common as an access site for coronary procedures. Since the first "Best Practices" paper in 2013, ongoing trials have shed further light onto the safest and most efficient methods to perform these procedures. Specifically, this document comments on the use of ultrasound to facilitate radial access, the role of ulnar artery access, the utility of non-invasive testing of collateral flow, strategies to prevent radial artery occlusion, radial access for primary PCI and topics that require further study.

Considerations for cardiac catheterization laboratory procedures during the COVID-19 pandemic perspectives from the Society for Cardiovascular Angiography and Interventions Emerging Leader Mentorship (SCAI ELM) Members and Graduates.

The novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is highly infectious, carries significant morbidity and mortality, and has rapidly resulted in strained health care system and hospital resources. In addition to patient-related care concerns in infected individuals, focus must also relate to diminishing community spread, protection of staff, case selection, and concentration of resources. The current document based on available data and consensus opinion addresses appropriate catheterization laboratory preparedness for treating these patients, including procedure-room readiness to minimize external contamination, safe donning and doffing of personal protective equipment (PPE) to eliminate risk to staff, and staffing algorithms to minimize exposure and maximize team availability. Case selection and management of both emergent and urgent procedures are discussed in detail, including procedures that may be safely deferred or performed bedside.

SCAI publications committee manual of standard operating procedures.

Evidence-based recommendations for clinical practice are intended to help health care providers and patients make decisions, minimize inappropriate practice variation, promote effective resource use, improve clinical outcomes, and direct future research. The Society for Cardiovascular Angiography and Interventions (SCAI) has been engaged in the creation and dissemination of clinical guidance documents since the 1990s. These documents are a cornerstone of the society's education, advocacy, and quality improvement initiatives. The publications committee is charged with oversight of SCAI's clinical documents program and has created this manual of standard operating procedures to ensure consistency, methodological rigor, and transparency in the development and endorsement of the society's documents. The manual is intended for use by the publications committee, document writing groups, external collaborators, SCAI representatives, peer reviewers, and anyone seeking information about the SCAI documents program.

Hot topics in interventional cardiology: Proceedings from the society for cardiovascular angiography and interventions 2020 think tank.

The society for cardiovascular angiography and interventions (SCAI) think tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community for high-level field-wide discussions. The 2020 think tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease (CHD). Each session was moderated by a senior content expert and co-moderated by a member of SCAI's emerging leader mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialogue from a broader base, and thereby aid SCAI and the industry community in developing specific action items to move these areas forward.

Expanding opportunities to understand quality and outcomes of peripheral vascular interventions: The ACC NCDR PVI Registry.

Lower extremity peripheral artery disease (PAD) and cerebrovascular disease (CeVD) are prevalent conditions in the United States, and both are associated with significant morbidity (eg, stroke, myocardial infarction, and limb loss) and increased mortality. With a growth in invasive procedures for PAD and CeVD, this demands a more clear responsibility and introduces an opportunity to study how patients are treated and evaluate associated outcomes. The American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) Peripheral Vascular Intervention (PVI) Registry is a prospective, independent collection of data elements from individual patients at participating centers, and it is a natural extension of the already robust NCDR infrastructure. As of September 20, 2018, data have been collected on 45,316 lower extremity PVIs, 12,417 carotid artery stenting procedures, and 11,027 carotid endarterectomy procedures at 208 centers in the United States. The purpose of the present report is to describe the patient and procedural characteristics of the overall cohort and the methods used to design and implement the registry. In collecting these data, ACC and ACC PVI Registry have the opportunity to play a pivotal role in scientific evidence generation, medical device surveillance, and creation of best practices for PVI and carotid artery revascularization.

Outcomes of multivessel vs culprit lesion-only percutaneous coronary intervention in patients with acute myocardial infarction complicated by cardiogenic shock: Evidence from an updated meta-analysis.

OBJECTIVES: This updated meta-analysis evaluated outcomes with multi-vessel (MV-PCI) vs culprit lesion-only percutaneous coronary intervention (CL-PCI), in patients with acute myocardial infarction (AMI) complicated by cardiogenic shock (CS). BACKGROUND: There is considerable debate regarding the optimal revascularization strategy in patients with AMI and CS, particularly regarding management of non-culprit lesions. METHODS: Databases were searched for studies comparing MV-PCI and CL-PCI in patients with AMI and CS. The primary outcome of interest was short-term all-cause mortality. Secondary outcomes included long-term mortality, repeat revascularization and myocardial reinfarction. Safety outcomes were stroke, acute renal failure and major bleeding. Pooled odds ratios (OR) and 95% confidence intervals (CI) were estimated using random-effects models. RESULTS: Our meta-analysis consisting of 14 studies (13 observational, 1 RCT) involving 8,552 patients showed that in comparison to CL-PCI, MV-PCI was associated with similar short-term mortality (OR 1.14; 95% CI 0.9-1.43), as well as similar long-term mortality (OR 0.94; 95% CI 0.68-1.28). There was no significant difference in the risk of myocardial reinfarction (OR 1.19; 95% CI 0.76-1.86), or repeat revascularization (OR 0.79; 95% CI 0.41-1.55) between the two groups. Compared to CL-PCI, MV-PCI was associated with a similar risk of bleeding (OR 1.13; 95% CI 0.91-1.40) and stroke (OR 1.28; 95% CI 0.84-1.96), but a higher risk of developing renal failure (OR 1.32; 95% CI 1.05-1.65). CONCLUSIONS: Our meta-analysis suggests that there is a higher risk of renal failure with no additional benefit in efficacy outcomes with MV-PCI, compared to CL-PCI in patients with AMI and CS.

A quality framework for the role of invasive, non-interventional cardiologists in the present-day cardiac catheterization laboratory: A multidisciplinary SCAI/HFSA expert consensus statement.

The present-day cardiac catheterization laboratory (CCL) is home to varied practitioners who perform both diagnostic, interventional, and complex invasive procedures. Invasive, non-interventional cardiologists are performing a significant proportion of the work as the CCL environment has evolved. This not only includes those who perform diagnostic-only cardiac catheterization but also heart failure specialists who may be involved in hemodynamic assessment and in mechanical circulatory support and pulmonary hypertension specialists and transplant cardiologists. As such, the training background of those who work in the CCL is varied. While most quality metrics in the CCL are directed towards evaluation of patients who undergo traditional interventional procedures, there has not been a focus upon providing these invasive, noninterventional cardiologists, hospital/CCL administrators, and CCL directors a platform for quality metrics. This document focuses on benchmarking quality for the invasive, noninterventional practice, providing this physician community with guidance towards a patient-centered approach to care, and offering tools to the invasive, noninterventionalists to help their professional growth. This consensus statement aims to establish a foundation upon which the invasive, noninterventional cardiologists can thrive in the CCL environment and work collaboratively with their interventional colleagues while ensuring that the highest quality of care is being delivered to all patients.

Length of stay following percutaneous coronary intervention: An expert consensus document update from the society for cardiovascular angiography and interventions.

Since the publication of the 2009 SCAI Expert Consensus Document on Length of Stay Following percutaneous coronary intervention (PCI), advances in vascular access techniques, stent technology, and antiplatelet pharmacology have facilitated changes in discharge patterns following PCI. Additional clinical studies have demonstrated the safety of early and same day discharge in selected patients with uncomplicated PCI, while reimbursement policies have discouraged unnecessary hospitalization. This consensus update: (1) clarifies clinical and reimbursement definitions of discharge strategies, (2) reviews the technological advances and literature supporting reduced hospitalization duration and risk assessment, and (3) describes changes to the consensus recommendations on length of stay following PCI (Supporting Information Table S1). These recommendations are intended to support reasonable clinical decision making regarding postprocedure length of stay for a broad spectrum of patients undergoing PCI, rather than prescribing a specific period of observation for individual patients.

Transcatheter versus surgical aortic valve replacement in intermediate-risk patients: Evidence from a meta-analysis.

OBJECTIVES: We performed a meta-analysis to evaluate the efficacy and safety of transcatheter aortic valve replacement (TAVR) in comparison to surgical aortic valve replacement (SAVR) in intermediate-risk patients. BACKGROUND: TAVR is an established treatment option in high-risk patients with severe aortic valve stenosis (AS). There are fewer data regarding efficacy of TAVR in intermediate-risk patients. METHODS: Databases were searched through April 30, 2016 for studies that compared TAVR with SAVR for the treatment of intermediate-risk patients with severe AS. We calculated summary risk ratios (RRs) and 95% confidence intervals (CIs) with the random-effects model. RESULTS: The analysis included 4,601 patients from 7 studies (2 randomized and 5 observational). There was no significant difference in all-cause mortality between the two groups after mean follow-up of 1.15 years [14.7% with TAVR vs 15.4% with SAVR; RR 0.93; 95% CI 0.77-1.12]. TAVR resulted in lower rates of acute kidney injury [number needed to treat (NNT) = 26], major bleeding (NNT = 4), and atrial-fibrillation (NNT = 6), but higher rates of major vascular complications [number needed to harm (NNH)= 18], and moderate/severe aortic regurgitation (NNH = 13). The rate of permanent-pacemaker implantation was significantly higher with TAVR in observational studies (RR 2.31; 95% CI 1.22-2.81), but not in RCTs (RR 1.21; 95% CI 0.93-1.56). No significant difference in the rate of stroke or myocardial infarction was observed. CONCLUSIONS: Our analysis of mid-term results showed that TAVR has similar clinical efficacy to SAVR in intermediate-risk patients with severe AS, and can be a suitable alternative to surgical valve replacement. © 2017 Wiley Periodicals, Inc.

Five-year mortality outcomes in patients with chronic kidney disease undergoing percutaneous coronary intervention.

OBJECTIVE: To examine peri-procedural and long-term outcomes in patients with chronic kidney disease (CKD) undergoing percutaneous coronary interventions (PCI). BACKGROUND: Patients with advanced CKD are considered high risk when undergoing PCI. Limited published data exist on quantifying risk and assessment of long-term outcomes after PCI in this group. METHODS: Examining the Cornell Coronary Registry, we prospectively collected data of 6,478 consecutive patients who underwent elective or urgent PCI between 2009 and 2013. Patients were grouped into CKD stages by estimated glomerular filtration rate (eGFR) according to KDOQI guidelines. Procedural and 30-day outcomes are reported with assessment of long-term differences in 5-year all-cause mortality. RESULTS: Patients were grouped by CKD stages: 1,351 patients with eGFR ≥90 mL/min/1.73 m2 (stage 1), 2,882 with eGFR 60-89 (stage 2), 1,742 with eGFR 30-59 (stage 3), 191 with eGFR 15-29 (stage 4), and 312 with eGFR <15 or on dialysis (stage 5). The incidence of post-procedural acute heart failure, stroke, new dialysis requirement, transfusions, and bleeding events were higher in patients with greater CKD stage (P < 0.05). Five-year Kaplan-Meier overall survival among CKD stages 1-5 was 98.1, 95.5, 91.8, 82.5, and 76.9%, respectively (P < 0.001 by log-rank test). The hazard ratios of all-cause mortality for CKD stages 2-5 as compared to stage 1 by multivariate Cox regression analysis were as follows: 1.32 (P = 0.26), 2.04 (P < 0.01), 2.79 (P < 0.01), and 5.49 (P < 0.001). CONCLUSION: Among patients undergoing PCI, lower GFR is associated with decreased long-term survival. © 2016 Wiley Periodicals, Inc.

Prognostic Importance of Diastolic Dysfunction in Relation to Post Procedural Aortic Insufficiency in Patients Undergoing Transcatheter Aortic Valve Replacement.

OBJECTIVES: We sought to examine whether baseline diastolic dysfunction (DD) is associated with increased mortality in patients who develop aortic insufficiency (AI) after transcatheter aortic valve replacement (TAVR). BACKGROUND: Significant post-TAVR AI is associated with increased mortality, likely secondary to adverse hemodynamics secondary to volume overload and decreased LV compliance from chronic pressure overload. However, the effect of baseline DD on outcomes of patients with post-TAVR AI has not been studied. METHODS: A total of 195 patients undergoing TAVR were included in the study. Patients with moderate-to-severe mitral stenosis, prior mitral valve replacement or atrial fibrillation were excluded. DD was classified at baseline by a 2-step approach as recommended by the American Society of Echocardiography while AI was evaluated 30 days post-TAVR. Follow up data up to 2 years post-TAVR was used in survival analysis. RESULTS: Patients with severe baseline DD who developed ≥mild post-TAVR AI had increased mortality compared to all other patients (HR = 3.89, CI: 1.76-8.6, P = 0.001), which remained significant after adjusting for post-TAVR AI, pre-TAVR AI, baseline mitral regurgitation, ejection fraction, pulmonary artery pressure, creatinine clearance and history of stroke. CONCLUSIONS: Even mild post-TAVR AI may have a negative impact on outcomes of patients with underlying severe DD. © 2016 Wiley Periodicals, Inc.

Impact of Paravalvular Aortic Insufficiency on Left Ventricular Remodeling and Mortality after Transcatheter Aortic Valve Replacement.

BACKGROUND: Paravalvular aortic regurgitation (PAR) remains a common complication following transcatheter aortic valve replacement (TAVR), and has been associated with increased mortality. Adverse left ventricular (LV) remodelling has been reported in patients with post-TAVR PAR, but the association between adverse LV remodeling and increased mortality remains unclear. The aim of the present study was to examine the association between PAR, LV remodeling and mortality following TAVR in a non-PARTNER (Placement of Aortic Transcatheter Valves) trial population. METHODS: A total of 195 patients that underwent TAVR was included in the study. The LV ejection fraction (LVEF), LV mass index (LVMI), LV internal dimension at systole (LVIDs) and diastole (LVIDd) were compared between patients with different degrees of PAR at baseline, and at one month and one year after TAVR. Survival analysis was performed for different degrees of PAR and LV remodeling. RESULTS: PAR ≥moderate was associated with increased mortality (HR 4.58 [1.80-11.63], p = 0.001), but PAR >mild was not. The LVIDd and LVIDs were persistently increased at one year after TAVR in patients with PAR >mild compared to those with PAR ≤mild (5.9 ± 0.8 cm versus 5.4 ± 0.7 cm, p = 0.02 and 4.4 ± 0.8 cm versus 3.9 ± 0.8, p = 0.03, respectively). The LVEF was improved similarly between the two groups at one year after TAVR (p = 0.1). Patients with PAR ≥moderate had significantly more adverse LV remodeling at one month after TAVR in terms of LVIDd, LVIDs, and LVMI. The degree of remodeling as expressed in terms of LVIDd, LVIDs, LVMI and LVEF changes from baseline did not have a direct impact on mortality. CONCLUSIONS: A worse PAR was associated with more adverse LV remodeling and a higher mortality after TAVR in a non-PARTNER patient population.