Device regulation and surveillance in vascular care: Challenges and opportunities.

Cardiovascular devices are essential for the treatment of cardiovascular diseases including cerebrovascular, coronary, valvular, congenital, peripheral vascular and arrhythmic diseases. The regulation and surveillance of vascular devices in real-world practice, however, presents challenges during each individual product's life cycle. Four examples illustrate recent challenges and questions regarding safety, appropriate use and efficacy arising from FDA approved devices used in real-world practice. We outline potential pathways wherein providers, regulators and payors could potentially provide high-quality cardiovascular care, identify safety signals, ensure equitable device access, and study potential issues with devices in real-world practice.

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.

REAFFIRMING THE CORE VALUES OF ACADEMIC CARDIOLOGY.

Academic medical centers are rapidly evolving into academic health systems with expanding clinical activity. These changes coupled with financial pressures due to decreased clinical reimbursements and failure of the NHLBI budget to keep pace with inflation are challenging the ability to succeed in all our missions. New governance structures and financial models may be necessary to success in our research and educational missions.

Novel method for left ventricular unloading utilizing percutaneous pulmonary artery drainage in cardiorespiratory failure due to COVID-19 infection.

Left ventricular (LV) unloading is an important concept in patients undergoing peripheral venoarterial extracorporeal membrane oxygenation (VA-ECMO). We present a case of a 32-year-old male in acute cardiorespiratory collapse due to coronavirus disease (COVID-19) who underwent VA-ECMO cannulation in the setting of cardiogenic shock and acute respiratory distress syndrome. Due to inability to utilize percutaneous LV assist device (pLVAD) for LV unloading due to small end diastolic dimension, alternative strategies were explored. A traditionally utilized right ventricular support device, the ProTek Duo (TandemLife, Pittsburgh, PA), was utilized to drain the pulmonary artery, leading to improvement in parameters for cardiogenic shock. To our knowledge, this is the first case in which a ProTek Duo has been utilized in conjunction with VA-ECMO to provide LV unloading in support of a patient in cardiogenic shock. This method can be employed in future challenging situations where pLVAD is not feasible.

Contemporary diagnosis and management of severe tricuspid regurgitation.

Many novel percutaneous interventions are being developed for application in the tricuspid valve position. At the present time in the United States, there are no commercially available transcathter devices for this application. This article reviews the growing evidence for diagnosing, imaging, and treating severe tricuspid regurgitation as well as the surgical and transcatheter options that are under current development and in various stages of clinical trials.

TAVR operator volumes, trends, and geographic variations amongst Medicare beneficiaries in the United States.

OBJECTIVES: To evaluate transcatheter aortic valve replacement (TAVR) operator procedural volumes, and describe temporal and geographic trends. BACKGROUND: TAVR is the standard of care for most patients with severe symptomatic aortic stenosis. Despite an association between operator procedural volume and outcomes, nationwide TAVR operator volumes have been incompletely described. METHODS: We queried the National Medicare Provider Utilization and Payment Database for transfemoral TAVRs from 2014 to 2018. Annual operator volume, state and regional volumes, and longitudinal trends were extracted and analyzed using descriptive statistics. RESULTS: In 2018, the mean annual operator volume was 23.6 TAVRs. The highest 1% of operators by volume performed 7.6% of total TAVR procedures in the United States, while 35.7% of operators performed 10 or fewer TAVRs per year. From 2014 to 2018, there was a 53.9% annualized increase in TAVRs, and the mean annual volume per operator grew from 12.5 to 23.6. There was more than five-fold variability in the density of operators (range 0.35-1.79 operators per 100,000 population) and mean operator volume by state (range 14.2-52.4 TAVRs per operator). CONCLUSIONS: In this nationally representative study of operators performing transfemoral TAVRs among Medicare patients, we found the mean annual volume of TAVR in 2018 to be 23.6 and has increased since 2014. There was considerable variability in operator density and procedural volumes, with a significant proportion of operators performing 10 or fewer TAVRs per year. Ambiguity remains in regard to the optimal balance of procedural requirements to sustain high efficacy outcomes and ensure critical access to TAVR therapies.

Incidence and outcomes of cardiogenic shock among women with spontaneous coronary artery dissection.

BACKGROUND: There is a paucity of data on cardiogenic shock (CS) incidence and outcomes among patients with spontaneous coronary artery dissection (SCAD). METHODS: Women admitted to the hospital for acute myocardial infarction (AMI) with and without SCAD were identified from the United States National Readmission Database from October 1, 2015 to December 31, 2018. We calculated the incidence of CS among women with AMI with and without SCAD and odds for developing CS after adjusting for baseline characteristics. In addition, we report the utilization of percutaneous coronary intervention, mechanical circulatory support, severe disability surrogates, and 30-day readmission rates. RESULTS: A total of 664,292 patients admitted for AMI were eligible for analysis, including 6643 patients with SCAD and 657,649 without SCAD. Patients with SCAD were younger (57 years [interquartile range, IQR 48-68] vs. 71 years [IQR 60-81], p < 0.01) and had fewer comorbidities yet had a higher incidence of CS as compared to patients without SCAD (9% vs. 5%, p < 0.01) and remained at elevated risk after adjusting for baseline comorbidities (adjusted odds ratio 1.5 [95% confidence interval, CI 1.2-1.7]). Among patients who developed CS, those with SCAD had lower in-hospital mortality than non-SCAD (31% vs. 39%, p < 0.01), and were more likely to receive mechanical circulatory support. CONCLUSIONS: In a nationally representative sample of women admitted for AMI, we found that patients with SCAD had a higher risk of developing CS and required more frequent use of mechanical circulatory support but were more likely to survive to discharge than women suffering AMI from causes other than SCAD.

Age stratified sex-related differences in incidence, management, and outcomes of cardiogenic shock.

BACKGROUND: There is a lack of data on age-stratified sex differences in the incidence, treatment, and outcomes of cardiogenic shock (CS). We sought to study these differences from a contemporary database. METHODS: Patients admitted with CS (2004-2018) were identified from the United States National Inpatient Sample. We compared CS (acute myocardial infarction-related cardiogenic shock [AMI-CS] and non-acute myocardial infarction-related cardiogenic shock [Non-AMI-CS]) incidence, management, and outcomes in males and females, stratified into four age groups (20-44, 45-64, 65-84, and ≥85 years of age). Propensity score matching (PSM) was used for adjustment. RESULTS: A total of 1,506,281 weighted hospitalizations for CS were included (AMI-CS, 39%; Non-AMI-CS, 61%). Across all age groups, females had a lower incidence of CS compared with males. After PSM and among the AMI-CS cohort, higher mortality among females compared with males was observed in the age groups 45-64 (28.5% vs. 26.3%) and 65-84 years (39.3% vs. 37.9%) (p < 0.01, for all). Among the Non-AMI-CS cohort, higher mortality among females compared with males was observed in the age groups 20-44 (33.5% vs. 30.5%), 45-64 (35.1% vs. 31.9%), and 65-84 years (41.7% vs. 40.3%) (p < 0.01, for all). Similar age-dependent differences in the management of CS were also observed between females and males. CONCLUSIONS: Females have a lower incidence of CS regardless of age. Significant disparities in the management and outcomes of CS were observed based on sex. However, these disparities varied by age and etiology of CS (AMI-CS vs. Non-AMI-CS) with pronounced disparity among females in the age range of 45-84 years.

Tricuspid Valve Percutaneous Therapies.

PURPOSE OF REVIEW: In this review, we have focused on the currently available transcatheter tricuspid valve therapies, device selection, as well as role and management of tricuspid regurgitation (TR) in the setting of other transcatheter valvular procedures. RECENT FINDINGS: In this review, we have enlisted the recently finished as well as ongoing trials in the percutaneous tricuspid valve therapies. TR is highly prevalent yet remains underrecognized and is often untreated. TR has traditionally been managed conservatively with medical therapies including diuretics for volume management, whereas surgical therapies are reserved for those undergoing left-sided valvular surgery. Although the transcatheter devices for tricuspid repair and replacement are in clinical trials, the experience to date for their effectiveness and safety has been reassuring.

Spontaneous coronary artery dissection of the left anterior descending artery in a patient with COVID-19 infection.

A 48-year-old woman with a past medical history of migraines and hyperlipidemia presented due to severe retrosternal chest pain with no other associated signs or symptoms. The patient was hemodynamically stable and was found to have an elevated troponin with electrocardiogram showing no ischemic changes. Computed tomography of the coronary arteries showed a left dominant system with dissection extending from the mid-to-distal left anterior descending (LAD) artery. The patient was subsequently discharged on medical therapy but returned 3 days later due to worsening chest pain. Electrocardiogram revealed inferior and anteroseptal ST segment changes with peak troponin of 14.9 ng/ml (reference range <0.80 ng/ml). Coronavirus disease 2019 (COVID-19) nasopharyngeal swab was performed prior to urgent coronary angiogram. Coronary angiogram was performed with full personal protective equipment for respiratory and droplet precautions due to pending COVID-19 testing results. Angiogram revealed spontaneous coronary artery dissection (SCAD) extending from the ostium of the LAD to the distal vessel. COVID-19 testing returned positive while in intensive care unit. The patient was not a percutaneous coronary intervention candidate due to the extent of the dissection and was not a surgical candidate due to a lack of graftable target and medical management was continued. To our knowledge, this case is the first in which SCAD has been reported in the LAD in a patient with COVID-19 with no other symptoms of respiratory illness or symptoms classically associated with the novel coronavirus. SCAD should be considered on the differential as one of the various cardiac manifestations of COVID-19 infection.

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.

Reduced radiation exposure in the cardiac catheterization laboratory with a novel vertical radiation shield.

OBJECTIVES: Investigation of novel vertical radiation shield (VRS) in reducing operator radiation exposure. BACKGROUND: Radiation exposure to the operator remains an occupational health hazard in the cardiac catheterization laboratory (CCL). METHODS: A mannequin simulating an operator was placed near a computational phantom, simulating a patient. Measurement of dose equivalent and Air Kerma located the angle with the highest radiation, followed by a common magnification (8 in.) and comparison of horizontal radiation absorbing pads (HRAP) with or without VRS with two different: CCL, phantoms, and dosimeters. Physician exposure was subsequently measured prospectively with or without VRS during clinical procedures. RESULTS: Dose equivalent and Air Kerma to the mannequin was highest at left anterior oblique (LAO)-caudal angle (p < .005). Eight-inch magnification increased mGray by 86.5% and µSv/min by 12.2% compared to 10-in. (p < .005). Moving 40 cm from the access site lowered µSv/min by 30% (p < .005). With LAO-caudal angle and 8-in. magnification, VRS reduced µSv/min by 59%, (p < .005) in one CCL and µSv by 100% (p = .016) in second CCL in addition to HRAP. Prospective study of 177 procedures with HRAP, found VRS lowered µSv by 41.9% (µSv: 15.2 ± 13.4 vs. 26.2 ± 31.4, p = .001) with no difference in mGray. The difference was significant after multivariate adjustment for specified variables (p < .001). CONCLUSIONS: Operator radiation exposure is significantly reduced utilizing a novel VRS, HRAP, and distance from the X-ray tube, and consideration of lower magnification and avoiding LAO-caudal angles to lower radiation for both operator and patient.

Meta-analysis of bivalirudin versus heparin in transradial coronary interventions.

OBJECTIVES: We sought to evaluate the efficacy and safety of bivalirudin versus heparin in patients with coronary artery disease undergoing transradial artery coronary intervention (TRI). BACKGROUND: Bivalirudin and radial artery access are independently associated with improved cardiovascular outcomes. However, data supporting a strategy of combining both to achieve additive improvements in cardiovascular outcomes provide conflicting results. METHODS: A systematic search was performed to identify randomized controlled trials (RCTs) of bivalirudin, in which vascular access sites were reported. The primary outcome was net adverse clinical events (NACE) at 30 days. Secondary outcomes were long-term NACE, short-, and long-term major adverse cardiovascular events, all-cause mortality, myocardial infarction, unplanned revascularization, stent thrombosis, and major bleeding. RESULTS: We identified 10 RCTs, including 16,328 patients who underwent TRI (mean age 64.6 ± 15.7 years, 72.5% male). Bivalirudin use was associated with decreased 30-day NACE compared with heparin (6.3 vs. 7.4%; risk ratio [RR] = 0.87; 95% confidence interval [CI] = 0.76-0.99; p = .04; number needed to treat = 91). No significant interactions were observed based on clinical presentation, administration of P2Y12 inhibitors, or glycoprotein IIb/IIIa-receptor inhibitors (GPI) use. There were no significant differences between groups in any prespecified secondary outcomes. There was, however, a significant reduction of major bleeding in the bivalirudin group compared with heparin when used in combination with routine GPI (RR = 0.41; 95% CI = 0.19-0.90; p = .03). CONCLUSIONS: Among patients undergoing TRI, use of bivalirudin was associated with significantly reduced 30-day NACE compared with heparin. There was no significant difference in long term NACE, ischemic, or bleeding events compared with heparin.

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.

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.

A Comprehensive Update on Aspirin Management During Noncardiac Surgery.

Aspirin is considered critical lifelong therapy for patients with established cardiovascular (CV) disease (including coronary artery, cerebrovascular, and peripheral arterial diseases) and is consequently one of the most widely used medications worldwide. However, the indications for aspirin use continue to evolve and recent trials question its efficacy for primary prevention. Although one third of patients undergoing noncardiac surgery and at risk for a major adverse CV event receive aspirin perioperatively, uncertainty still exists about how aspirin should be optimally managed in this context, and significant practice variability remains. Recent trials suggest that the risks of continuing aspirin during the perioperative period outweigh the benefits in many cases, but data on patients with high CV risk remain limited. We performed a comprehensive PubMed and Medline literature search using the following keywords: aspirin, aspirin withdrawal, perioperative, coronary artery disease, cerebrovascular disease, peripheral artery disease, and CV disease; we manually reviewed all relevant citations for inclusion. Patients taking aspirin for the primary prevention of CV disease should likely discontinue it during the perioperative period, especially when there is a high risk of bleeding. Patients with established CV disease but without a coronary stent should likely continue aspirin during the perioperative period unless undergoing closed-space surgery. Patients with a history of coronary stenting also likely need aspirin continuation throughout the perioperative period for nonclosed space procedures. Perioperative clinicians need to balance the risks of ceasing aspirin before surgery against its continuation during the perioperative interval using a patient-specific strategy. The guidance on decision-making with regard to perioperative aspirin cessation or continuation using currently available clinical data from studies in high-risk patients along with nonclinical aspirin studies is conflicting and does not enable a simplified or unified answer. However, pertinent guidelines on CV disease management provide a basic framework for aspirin management, and large trial findings provide some insight into the safety of perioperative aspirin cessation in some contexts, although uncertainty on perioperative aspirin still exists. This review provides an evidence-based update on perioperative aspirin management in patients undergoing noncardiac surgery with a focus on recommendations for perioperative clinicians on continuing versus holding aspirin during this context.

Safety and efficacy of short-term (1 to 3 months) dual antiplatelet therapy in patients undergoing percutaneous coronary interventions: a meta-analysis of randomized controlled trials.

Among patients who have undergone percutaneous coronary intervention (PCI), the use of dual antiplatelet therapy (DAPT) is associated with increased risk of bleeding, but decreased stent thrombosis and myocardial infarction unrelated to the stent. As PCI techniques and devices have progressed, the optimal duration of DAPT has come into question. We identified all randomized controlled trials (RCTs) of patients undergoing PCI, who received one or more drug eluting stents (DES) for stable coronary artery disease (CAD) or acute coronary syndrome (ACS), and randomized to short (1-3 months) versus standard duration DAPT. The prespecified primary outcome was major adverse cardiovascular events (MACE). Important secondary outcomes were net adverse clinical events (NACE) defined as MACE and major bleeding; any bleeding; major bleeding; all-cause death; cardiovascular death. We calculated hazard ratios (HR) and 95% confidence intervals (CI) using random-effects model. Analysis included 7 RCTs, comprising 35,857 patients and 53,321 patient-years of follow-up. The mean (SD) age of patients was 64.4 (10.6) years, 49.6% of patients presented with ACS, and 25.5% were female. There was no difference between short and standard-length DAPT in regards to MACE (HR = 0.93; 95% CI 0.84-1.03; p = 0.19), NACE (HR = 0.93; 95% CI 0.85-1.02; p = 0.12), all-cause death (HR = 0.92; 95% CI 0.80-1.05; p = 0.21), or cardiovascular death (HR = 0.85; 95% CI 0.64-1.13; p = 0.26). However, short-term DAPT was associated with significantly reduced major bleeding events (HR = 0.67; 95% CI 0.47-0.95; p = 0.03) and any bleeding event (HR = 0.63; 95% CI 0.44-0.90; p = 0.01) compared with standard-length DAPT. Among patients undergoing PCI for CAD, the use of short-term DAPT (1-3 months) followed by single antiplatelet therapy was associated with a lower incidence of clinically relevant bleeding events, but with similar risk of MACE, all-cause death, and cardiovascular death compared with standard duration DAPT.

Replacing the mitral valve alone does not completely fix the heart!

TMVR for degenerative (stenosis and regurgitation) mitral valve prosthesis (valves and rings) results in immediate and sustainable reduction but not normalization of left atrial pressure. Concomitant comorbid conditions such as left ventricular diastolic dysfunction adversely impact left atrial pressure and should be treated. The long-term impact of postprocedural ASD and patient-prosthesis mismatch need to be systematically evaluated so we develop the appropriate data to guide decision making as more transeptal mitral procedures are being performed.

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.

Cardiovascular and Ventilatory Consequences of Laparoscopic Surgery.

Although laparoscopic surgery accounts for >2 million surgical procedures every year, the current preoperative risk scores and guidelines do not adequately assess the risks of laparoscopy. In general, laparoscopic procedures have a lower risk of morbidity and mortality compared with operations requiring a midline laparotomy. During laparoscopic surgery, carbon dioxide insufflation may produce significant hemodynamic and ventilatory consequences such as increased intraabdominal pressure and hypercarbia. Hemodynamic insults secondary to increased intraabdominal pressure include increased afterload and preload and decreased cardiac output, whereas ventilatory consequences include increased airway pressures, hypercarbia, and decreased pulmonary compliance. Hemodynamic effects are accentuated in patients with cardiovascular disease such as congestive heart failure, ischemic heart disease, valvular heart disease, pulmonary hypertension, and congenital heart disease. Prevention of cardiovascular complications may be accomplished through a sound understanding of the hemodynamic and physiological consequences of laparoscopic surgery as well as a defined operative plan generated by a multidisciplinary team involving the preoperative consultant, anesthesiologist, and surgeon.