Reducing Cardiovascular Disease-An Alternative Approach.

PURPOSE: Statin drugs are effective at reducing cardiovascular events, but adherence to statin therapy remains a problem for patients and their physicians. We review a paper estimating the economic costs of poor adherence to statin drugs. METHODS: The authors examined two large databases (Medicare and Market Scan databases) including 230,000 patients with hospitalization for myocardial infarction between 2018 and 2019 to determine how many patients were not adhering to guideline-recommended anti-hyperlipidemic medications. They have also calculated the potential consequences of patients who are not adhering to the recommended therapy. RESULTS: The authors estimate that if all patients were receiving guideline-directed medical therapy, then a 22% relative risk reduction would occur in the 3-year period following discharge from the initial cardiovascular event. These findings are consistent with prior reports. This editorial discusses rationale and strategies clinicians can use to improve patients' compliance with recommendations for lipid-lowering therapy. CONCLUSION: The authors conclude that better compliance with guideline-directed lipid therapy after a cardiovascular event would lead to a large reduction in second events. Increased efforts by clinicians to improve adherence to statin therapy are warranted.

Discharge of Acute Coronary Syndrome Patients on Sub-Optimal Dual Anti-Platelet Therapy: A Single Center Experience.

PURPOSE: To identify and quantify the reasons why acute coronary syndrome (ACS) patients undergoing stenting at the University of New Mexico Hospital (UNMH) were prescribed sub-optimal dual antiplatelet therapy (DAPT) at discharge, and to identify practice patterns that could potentially lead to improved DAPT treatment for these patients. METHODS: We reviewed electronic medical records and cardiac catheterization records of 326 patients who underwent percutaneous coronary intervention (PCI) at UNMH between January 1, 2021, and June 30, 2022 and identified 229 ACS patients who survived until discharge. Demographic and clinical characteristics relevant to P2Y12 inhibitor selection were obtained from a review of medical records. Pharmacists' notes documenting their efforts to secure appropriate insurance coverage and reasons for discharging patients on clopidogrel rather than ticagrelor/prasugrel were reviewed. Patients discharged on aspirin and clopidogrel underwent review of medical records and cardiac catheterization lab records to determine if the discharge P2Y12 drug was appropriate. Reasons for inappropriate discharge on clopidogrel were categorized as cost/insurance, patient preference, concern for daily adherence to a twice-daily medication, and maintenance of pre-hospital clopidogrel therapy rather than switch to ticagrelor after PCI. RESULTS: The 229 ACS patients included 87 (38.0%) appropriately discharged on ticagrelor/prasugrel, 63 (27.5%) appropriately discharged on clopidogrel, 75 (32.8%) discharged on sub-optimal clopidogrel, and 4 (1.7%) not discharged on a P2Y12 inhibitor. For patients inappropriately discharged on clopidogrel (n = 75), the most common reasons were cost or lack of insurance (n = 56) and clinical inertia (taking clopidogrel before PCI and maintained on it afterward) (n = 17). Sub-optimal P2Y12 therapy at discharge was significantly associated with lack of insurance (odds ratio 21.5, 95% confidence interval 5.33-156,p < 0.001) but not with ethnicity, age, sex, or diabetes. CONCLUSION: At the University of New Mexico, a safety-net hospital, increasing financially restricted access to ticagrelor/prasugrel could help up to 24.5% of ACS patients reduce their risk of ischemic events. For patients admitted on clopidogrel DAPT, escalating to ticagrelor/prasugrel could reduce ischemic risk in 7.4%. Expanding and improving healthcare insurance coverage might reduce the frequency of discharge on sub-optimal P2Y12 therapy.

Ellis type 4 coronary artery perforation during percutaneous coronary intervention: Case series and review.

Ellis type 4 coronary artery perforation (CAP4), also referred to as Ellis type 3 cavity-spilling perforation, is a rare but life-threatening complication of percutaneous coronary intervention characterized by extravasation of blood into a cardiac chamber, anatomic cavity, or coronary sinus or vessel. CAP4 is uncommon, accounting for 1.9% to 3.0% of all CAP. Only 11 cases of CAP4 have been reported in detail; we report an additional two cases and review prior reports of this rare complication. Our first case highlights a patient with chronic anginal symptoms due to a 75% concentric stenotic lesion in the mid-LAD. Revascularization was complicated by perforation during pre-dilation with robust contrast extravasation into the left ventricle. Successful postperforation hemostasis was achieved with heparin reversal and covered stent placement. The second case demonstrates another major mechanism of CAP4: wire perforation. During intervention, the absence of blood flow distal to the lesion in the setting of an ST segment elevation myocardial infarction obscured the course of the nonhydrophilic floppy wire leading to perforation that was managed conservatively. In our scoping review, we found that the majority of CAP4 occurred in the LAD. The most frequently involved cavity was the left ventricle-other cavities involved were the right ventricle and coronary veins. Common etiologies of CAP4 included guidewire perforation (62%) and balloon dilation (31%). Perforation was managed with reversal of anticoagulation in 46% of cases, prolonged balloon inflation in 54% of cases, and covered stent deployment in 15% of cases. No patients required surgical repair or pericardiocentesis and perforations were successfully sealed in all cases. In-hospital mortality was 0%.

The changing landscape of interventional cardiology: A survival guide in the era of health system consolidation: The Society of Cardiovascular Angiography and Interventions affirms the value of this manuscript.

Practice environments for interventional cardiologists have evolved dramatically and now include small independent practices, large cardiology groups, multispecialty groups, and large integrated health systems. Increasingly, cardiologists are employed by hospitals or health systems. Data from MedAxiom and the American College of Cardiology (ACC) demonstrate an exponential increase in the percentage of cardiologists in employed positions from 10% in 2009 to 87% in 2020. This white paper explores these profound changes, considers their impact on interventional cardiologists, and offers guidance on how interventional cardiologists can best navigate this challenging environment. Finally, the paper offers a potential model to improve the employed physician experience through greater physician involvement in decision making, which may increase jobs satisfaction.

Interventional economics provide a roadmap to better patient care.

Costs of percutaneous coronary intervention including the index procedure and care in the subsequent 30 days are increased by half for patients who are readmitted, and increased up to two-fold for those who have major adverse events during the initial admission. Many factors "predicting" adverse events and readmission are not modifiable. However, some are modifiable. Interventionalists should focus on those. In addition to using strategies to avoid adverse events, interventionalists should lead teams to implement strategies to prevent readmission. This will require a new nonprocedural focus for interventionalists.

The appropriate use criteria: Improvements for its integration into real world clinical practice.

The purpose of this position statement is to suggest ways in which future appropriate use criteria (AUC) for coronary revascularization might be restructured to: (1) incorporate improvement in quality of life and angina relief as primary goals of therapy, (2) integrate the findings of recent trials into quality appraisal, (3) employ the combined information of the coronary angiogram and invasive physiologic measurements together with the results of stress test imaging to assess risk, and (4) recognize the essential role that patient preference plays in making individualized therapeutic decisions. The AUC is a valuable tool within the quality assurance process; it is vital that interventionists ensure that percutaneous coronary intervention case selection is both evidence-based and patient oriented. Appropriate patient selection is an important quality indicator and adherence to evidence-based practice should be one metric in a portfolio of process and outcome indicators that measure quality.

Racial and ethnic disparities in coronary, vascular, structural, and congenital heart disease.

Cardiovascular disease (CVD) remains the leading cause of death in the United States. However, percutaneous interventional cardiovascular therapies are often underutilized in Blacks, Hispanics, and women and may contribute to excess morbidity and mortality in these vulnerable populations. The Society for Cardiovascular Angiography and Interventions (SCAI) is committed to reducing racial, ethnic, and sex-based treatment disparities in interventional cardiology patients. Accordingly, each of the SCAI Clinical Interest Councils (coronary, peripheral, structural, and congenital heart disease [CHD]) participated in the development of this whitepaper addressing disparities in diagnosis, treatment, and outcomes in underserved populations. The councils were charged with summarizing the available data on prevalence, treatment, and outcomes and elucidating potential reasons for any disparities. Given the huge changes in racial and ethnic composition by age in the United States (Figure 1), it was difficult to determine disparities in rates of diagnosis and we expected to find some racial differences in prevalence of disease. For example, since the average age of patients undergoing transcatheter aortic valve replacement (TAVR) is 80 years, one may expect 80% of TAVR patients to be non-Hispanic White. Conversely, only 50% of congenital heart interventions would be expected to be performed in non-Hispanic Whites. Finally, we identified opportunities for SCAI to advance clinical care and equity for our patients, regardless of sex, ethnicity, or race.

SCAI expert consensus update on best practices in the cardiac catheterization laboratory: This statement was endorsed by the American College of Cardiology (ACC), the American Heart Association (AHA), and the Heart Rhythm Society (HRS) in April 2021.

The current document commissioned by the Society for Cardiovascular Angiography and Interventions (SCAI) and endorsed by the American College of Cardiology, the American Heart Association, and Heart Rhythm Society represents a comprehensive update to the 2012 and 2016 consensus documents on patient-centered best practices in the cardiac catheterization laboratory. Comprising updates to staffing and credentialing, as well as evidence-based updates to the pre-, intra-, and post-procedural logistics, clinical standards and patient flow, the document also includes an expanded section on CCL governance, administration, and approach to quality metrics. This update also acknowledges the collaboration with various specialties, including discussion of the heart team approach to management, and working with electrophysiology colleagues in particular. It is hoped that this document will be utilized by hospitals, health systems, as well as regulatory bodies involved in assuring and maintaining quality, safety, efficiency, and cost-effectiveness of patient throughput in this high volume area.

One or two diagnostic catheters with radial access: Does single yield celerity or double cause trouble?

One-third of interventionalists still use dedicated left and right coronary catheters for diagnostic angiography with radial access, despite some evidence that a single "universal" catheter strategy is superior. This meta-analysis of seven randomized controlled studies of one- versus two-catheter strategies with radial access showed no differences in procedural time, fluoroscopy time, or contrast use. Use of an additional catheter was more frequent with the one-catheter strategy but radial spasm was more common with a two-catheter strategy. This meta-analysis did not address cost, complication rates, or radial occlusion rates. Differences in these factors, if found in future studies, may yet prove one strategy or the other to be superior.

Communication to cure cath chaos.

Communication errors in the cath lab may lead to incorrect medication administration or dosing, or incorrect sizes of devices deployed in patients, with catastrophic results. Use of closed-loop communication minimizes these errors. In this study, two rounds of quality improvement projects improved, but did not completely close the communication gap. Standard setting by professional societies and individual cath lab leaders may be necessary to improve the use of closed-loop communication in cath labs-although a completely successful strategy remains to be identified.

The final nail in the coffin for immediate catheterization for refractory cardiac arrest with ongoing chest compressions.

In a cohort of 219 patients with out of hospital cardiac arrest, survival correlated with age, initial shockable rhythm, recovery of spontaneous circulation (ROSC) before starting catheterization, and initial pH. Mortality was 98% in patients who underwent catheterization before ROSC. Early studies of emergency extra-corporeal membrane oxygenation life support combined with hypothermia, and coronary intervention, suggest this "hyper-invasive" strategy may offer significant improvement in outcomes compared to conventional strategies employed in this study.

Post-dilatation trepidation: Post-dil is "no big dil".

Selective stent post-dilatation (PD) in a cohort of STEMI patients did not affect major adverse cardiac events but it did decrease device-oriented composite events, a secondary composite end point of less clear significance. This study suggests that selective stent PD in STEMI does not increase the incidence of acute no-reflow or long-term adverse clinical events. In primary PCI for STEMI, if the stent appears under-expanded, then PD, perhaps guided by intravascular imaging (which was not reported in this study), is reasonable.

Barriers to use of radial access for percutaneous coronary intervention.

OBJECTIVES: The aim of this study was to identify barriers to transradial access percutaneous coronary intervention (PCI). BACKGROUND: Transradial access yields fewer vascular complications, earlier ambulation, and more patient comfort. However, the adoption to practice is slow, and transfemoral access is still commonly used. METHODS: We identified all PCIs done by one operator in a radial-first trainee-driven practice. The individual charts were reviewed for all PCIs using femoral access. Reasons for not using radial access were identified. Descriptive statistics were used to report reasons for not using transradial access. Analyses were performed on a per-procedure basis. RESULTS: Of 1,948 PCIs, 1,790 (92%) were via radial access and 158 (8%) via femoral access. Femoral access was used to bail out unsuccessful radial access in 21 PCIs (13% of all femoral PCIs, 1% of all PCIs). Radial access was unsuccessful due to failure to cannulate radial artery, radial artery spasm, and radial loop in majority of radial access failure PCIs (n = 13). Femoral access was used as a primary strategy in 137 PCIs (87% of all femoral PCIs, 7% of all PCIs), mostly due to undetectable radial artery pulse (both left and right) (n = 40). CONCLUSIONS: Radial access can be used for PCI safely and effectively. Inadequate radial pulse is the main barrier. Adjunctive strategies such as ulnar access and use of ultrasound may further increase the success rate of arterial access from the upper extremities.

A randomized controlled trial to assess operator radiation exposure from cardiac catheterization procedures using RAD BOARD® with standard pelvic shielding versus standard pelvic shielding alone.

OBJECTIVE: To study radiation exposure to the primary operator during diagnostic cardiac catheterizations using a radio-dense RAD BOARD® radial access arm board. BACKGROUND: The use of radial access for catheterization in the United States has increased from 1% in 2007 to 41% in 2018. Compared to femoral access, operator radiation exposure from radial access is similar or higher. The RAD BOARD radio-dense radial access arm board has been marketed as reducing radiation to operators by 44%. MATERIALS AND METHODS: We randomized 265 patients undergoing catheterization via right radial access to standard pelvic lead drape shielding (nonboard group) versus RAD BOARD in addition to pelvic drape (board group). Operator radiation exposure was measured using Landauer Microstar nanoDot™ badges worn by the operator. RESULTS: Board and nonboard groups were similar with respect to demographic and procedural variables. Mean operator dose per case was higher in the board group (.65mSieverts) than in the nonboard group (.56mSieverts, P < 0.0001). In sub-group analyses, radiation doses were higher in the board group compared to the nonboard group in patients across all body mass index groups (P < 0.03). In multivariate analysis, operator dose correlated with use of the RAD BOARD more closely than any other variable (P < 0.001). Post hoc analysis of the table setup with RAD BOARD revealed that use of RAD BOARD prevented placement of a shield normally inserted into the top of the standard below-table shield. CONCLUSION: RAD BOARD with the pelvic shield was associated with higher radiation exposure to the operator compared with pelvic shield alone, likely due to inability to use standard radiation shielding along with the RAD BOARD.

SCAI position statement on the performance of percutaneous coronary intervention in ambulatory surgical centers.

The Centers for Medicare & Medicaid Services (CMS) began reimbursement for percutaneous coronary intervention (PCI) performed in ambulatory surgical centers (ASC) in January 2020. The ability to perform PCI in an ASC has been made possible due to the outcomes data from observational studies and randomized controlled trials supporting same day discharge (SDD) after PCI. In appropriately selected patients for outpatient PCI, clinical outcomes for SDD or routine overnight observation are comparable without any difference in short-term or long-term adverse events. Furthermore, a potential for lower cost of care without a compromise in clinical outcomes exists. These studies provide the framework and justification for performing PCI in an ASC. The Society for Cardiovascular Angiography and Interventions (SCAI) supported this coverage decision provided the quality and safety standards for PCI in an ASC were equivalent to the hospital setting. The current position paper is written to provide guidance for starting a PCI program in an ASC with an emphasis on maintaining quality standards. Regulatory requirements and appropriate standards for the facility, staff and physicians are delineated. The consensus document identified appropriate patients for consideration of PCI in an ASC. The key components of an ongoing quality assurance program are defined and the ethical issues relevant to PCI in an ASC are reviewed.

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.

A hot lead on reducing infarct size.

The intracoronary hyperoxemic oxygen therapy study, designed to demonstrate the safety of supersaturated oxygen (SSO2 ) infused into the left main coronary after percutaneous coronary intervention for anterior ST-elevation myocardial infarction (STEMI), demonstrated a net adverse clinical event rate of 7.1%, lower than the Food and Drug Administration-set goal of 10.7%. SSO2 , which has reduced infarct size in clinical STEMI trials, might become an important strategy for treating anterior STEMIs. Larger postmarketing trials are needed to determine whether decreases in infarct size are observed in real-world populations, whether they translate into improved clinical outcomes, and whether modifications in technique can streamline the administration of SSO2 therapy.

Views of Appropriate Use Criteria for catheterization and percutaneous coronary revascularization by practicing interventional cardiologists: Results of a survey of American College of Cardiology Interventional Section members.

OBJECTIVES: The American College of Cardiology (ACC) Interventional Section Council leadership sought to examine the views of interventional cardiologists regarding the practical implementation and the value of the Appropriate Use Criteria (AUC) in their clinical practice. BACKGROUND: The ACC AUC for revascularization were originally intended to assess trends in revascularization patterns by hospitals and physicians to ensure that both under- and over-utilization were minimized. As a quality assurance tool, the AUC were designed to allow physicians to obtain insight into their practice patterns and improve their practice. Recent trends toward tying payment to performance have raised concerns that these criteria will be incorrectly applied to individual patient reimbursement, which is not what they were designed to do. Consequently, the AUC have become controversial, not for their value in quality assessment, but for the manner in which agencies have used the AUC as a tool to potentially deny payment for certain patients. METHODS: Utilizing an online survey, members of the ACC Interventional Section were queried regarding the use of AUC, how they use them, and how they feel utilization impacts the care of patients. RESULTS: We found substantial variability in how the AUC were utilized and concern regarding the value of AUC. Among our findings was that respondents were split (51% vs 49%) regarding the value of AUC to patients and/or their laboratory. CONCLUSIONS: In this article, we discuss the implications of these findings and consider options on how AUC might be made a better-accepted and more impactful tool for clinicians and patients.

SCAI/ACVP expert consensus statement on cardiovascular catheterization laboratory economics: If the cath lab is your home you should understand its finances: This statement was endorsed by the Alliance of Cardiovascular Professionals (ACVP) in April 2019.

This article is intended for any physician, administrator, or cardiovascular catheterization laboratory (CCL) staff member who desires a fundamental understanding of finances and economics of CCLs in the United States. The authors' goal is to illuminate general economic principles of CCL operations and provide details that can be used immediately by CCL leaders. Any article on economics in medicine should start by acknowledging the primacy of the principles of medical ethics. While physicians have been trained to act in the best interests of their patients and avoid actions that would harm patients it is vitally important that all professionals in the CCL focus on patients' needs. Caregivers both at the bedside and in the office must consider how their actions will affect not only the patient they are treating at the time, but others as well. If the best interests of a patient were to conflict with any recommendation in this article, the former should prevail. KEY POINTS: To be successful and financially viable under current payment systems, CCL physicians, and managers must optimize the outcomes and efficiency of care by aligning CCL leadership, strategy, organization, processes, personnel, and culture. Optimizing a CCL's operating margin (profitability) requires maximizing revenues and minimizing expenses. CCL managers often focus on expense reduction; they should also pay attention to revenue generation. Expense reduction depends on efficiency (on-time starts, short turn-over time, smooth day-to-day schedules), identifying cost-effective materials, and negotiating their price downward. Revenue optimization requires accurate documentation and coding of procedures, comorbidities, and complications. In fee-for-service and bundled payment reimbursement systems, higher volumes of procedures yield higher revenues. New procedures that improve patient care but are expensive can usually be justified by negotiating with vendors for lower prices and including the "halo effect" of collateral services that accompany the new procedure. Fiscal considerations should never eclipse quality concerns. High quality CCL care that prevents complications, increases efficiency, reduces waste, and eliminates unnecessary procedures represents a win for patients, physicians, and CCL administrators.