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.

On-Treatment Platelet Reactivity and Ischemic Outcomes in Patients With Diabetes Mellitus: Two-Year Results From ADAPT-DES.

Background Diabetes mellitus and high platelet reactivity (HPR) on clopidogrel are both associated with increased risk of ischemic events after percutaneous coronary intervention, but whether the HPR-associated risk of adverse ischemic events differs by diabetes mellitus status is unknown. Methods and Results ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) was a prospective, multicenter registry of patients treated with coronary drug-eluting stents. HPR was defined as P2Y12 reaction units >208 by the VerifyNow point-of-care assay. Cox multivariable analysis was used to assess whether HPR-associated risk of major adverse cardiac events (MACE; cardiac death, myocardial infarction, or stent thrombosis) varied for patients with insulin-treated diabetes mellitus (ITDM), non-ITDM, and no diabetes mellitus. Diabetes mellitus and HPR were included in an interaction analysis. Of 8582 patients enrolled, 2429 (28.3%) had diabetes mellitus, of whom 998 (41.1%) had ITDM. Mean P2Y12 reaction units were higher in patients with diabetes mellitus versus without diabetes mellitus, and HPR was more frequent in patients with diabetes mellitus. HPR was associated with consistently increased 2-year rates of MACE in patients with and without diabetes mellitus (Pinteraction=0.36). A significant interaction was present between HPR and non-insulin-treated diabetes mellitus versus ITDM for 2-year MACE (adjusted hazard ratio [HR] for non-ITDM, 2.28 [95% CI, 1.39-3.73] versus adjusted HR for ITDM, 1.02 [95% CI, 0.70-1.50]; Pinteraction=0.01). Conclusions HPR was more common in patients with diabetes mellitus and was associated with an increased risk of MACE in both patients with and without diabetes mellitus. In patients with diabetes mellitus, a more pronounced effect of HPR on MACE was present in lower-risk non-ITDM patients than in higher-risk patients with ITDM. Registration URL: https://clinicaltrials.gov/ct2/show/NCT00638794; Unique identifier: NCT00638794. ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents).

Stent Expansion Indexes to Predict Clinical Outcomes: An IVUS Substudy From ADAPT-DES.

OBJECTIVES: The aim of this study was to evaluate various stent expansion indexes to determine the best predictor of clinical outcomes. BACKGROUND: Numerous intravascular ultrasound (IVUS) studies have shown minimum stent area (MSA) to be the most powerful predictor of future events. METHODS: ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) was a prospective, multicenter registry of 8,582 patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents. Native coronary artery lesions treated with IVUS-guided PCI with final analyzable IVUS were included. Ten stent expansion indexes (MSA, MSA/vessel area at MSA site, conventional stent expansion [MSA/average of proximal and distal reference luminal area], minimum stent expansion using Huo-Kassab or linear model accounting for vessel tapering, stent asymmetry [minimum/maximum stent diameter within the entire stent], stent eccentricity [smallest minimum/maximum stent diameter at a single slice within the stent], IVUS-XPL [Impact of intravascular Ultrasound Guidance on Outcomes of Xience Prime Stents in Long Lesions] criteria, ULTIMATE [Intravascular Ultrasound Guided Drug Eluting Stents Implantation in "All-Comers" Coronary Lesions] criteria, and ILUMIEN IV criteria) were evaluated for their associations with lesion-specific 2-year clinically driven target lesion revascularization (TLR) or definite stent thrombosis. RESULTS: Overall, 2,140 lesions in 1,831 patients were included; final MSA measured 6.2 ± 2.4 mm2. Among the 10 stent expansion indexes, only MSA/vessel area at the MSA site was independently associated with 2-year clinically driven TLR or definite stent thrombosis (hazard ratio: 0.77; 95% confidence interval: 0.59-0.99; P = 0.04) after adjusting for morphologic and procedural parameters. CONCLUSIONS: In this IVUS-guided PCI cohort with excellent final MSA overall, stent/vessel area at the MSA site, an index of relative stent expansion, was superior to absolute MSA and other expansion indexes in predicting 2-year clinically driven TLR or definite stent thrombosis.

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.

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.

Stent Thrombosis Risk Over Time on the Basis of Clinical Presentation and Platelet Reactivity: Analysis From ADAPT-DES.

OBJECTIVES: The aim of this study was to determine the risk period for increased stent thrombosis (ST) after percutaneous coronary intervention (PCI) in patients with acute coronary syndromes (ACS) and whether this increased risk is related to high platelet reactivity (HPR). BACKGROUND: ST risk after PCI is higher among patients with ACS than those with stable ischemic heart disease. When ST risk is highest in patients with ACS and how that is affected by HPR is unknown. METHODS: Using the ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) registry, ST rates during 2-year follow-up post-PCI with drug-eluting stents were compared among patients presenting with ACS (myocardial infarction [MI] or unstable angina) or stable ischemic heart disease (non-ACS). Landmark analyses were done at 30 days and 1 year post-PCI. Platelet reactivity on aspirin and clopidogrel post-PCI was assessed using VerifyNow assays. RESULTS: Of 8,582 patients, 2,063 presented with MI, 2,370 with unstable angina, and 4,149 with non-ACS. Incidence rates of HPR were 48.0%, 43.3%, and 39.8%, respectively (p < 0.001). Within the first 30 days post-PCI, patients presenting with MI had increased ST risk compared with patients with non-ACS (hazard ratio [HR]: 4.52; 95% confidence interval [CI]: 2.01 to 10.14; p < 0.001). After 30 days, relative ST risks were progressively lower and no longer significant between groups (31 days to 1 year post-PCI: HR: 1.97; 95% CI: 0.80 to 4.85; >1 year post-PCI: HR: 0.89; 95% CI: 0.27 to 2.92). The elevated ST risk in patients with MI within 30 days was largely confined to those with HPR on clopidogrel (HR: 5.77; 95% CI: 2.13 to 15.63; p < 0.001). CONCLUSIONS: Among patients undergoing PCI, rates of ST during 2-year follow-up were highest in those with MI and lowest in those with non-ACS. Increased ST risk in patients with MI was greatest in the first 30 days post-PCI and was observed predominantly among those with increased HPR on clopidogrel. These findings emphasize the importance of adequate P2Y12 inhibition after MI, especially within the first 30 days after stent implantation.

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.

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.

Impact of high on-treatment platelet reactivity on outcomes following PCI in patients on hemodialysis: An ADAPT-DES substudy.

OBJECTIVES: We sought to compare clinical outcomes after percutaneous coronary intervention (PCI) in patients on versus not on hemodialysis (HD) and examine whether high on-treatment platelet reactivity (HPR) further impacts outcomes among patients on HD. BACKGROUND: Both chronic kidney disease (CKD) and HPR are predictors of major adverse cardiac events (MACE) after PCI. METHODS: Two-year outcomes of patients from the prospective, multicenter ADAPT-DES study (N = 8,582) were analyzed according to HD status at enrollment. All patients underwent platelet function testing with the VerifyNow assay; HPR on clopidogrel was defined as P2Y12 reaction units (PRU) >208. RESULTS: Compared with non-HD patients, patients on HD (n = 85) had significantly higher baseline PRU (median 254 vs. 188, p = .001) and more frequently had HPR (61.7% vs. 42.5%, p < .001). HD was associated with increased 2-year rates of MACE (death, myocardial infarction (MI) or definite stent thrombosis (ST); 23.4% vs. 10.7%, p < .001). HD was also strongly associated with 2-year overall mortality, cardiac death, MI, target vessel revascularization, major bleeding, stroke and ST. Following adjustment for HPR and other covariates, HD was independently associated with overall mortality, MI, ST, and major bleeding at 2 years. The relationship between HD status and 2-year MACE was consistent in patients with and without HPR (Pinteraction = .78). CONCLUSIONS: Nearly two-thirds of patients on HD exhibited HPR on clopidogrel, and both HD and HPR were independently associated with 2-year adverse outcomes after DES implantation. However, the deleterious impact of HD on clinical outcomes was present in both patients with and without HPR.

Association Between Hypertension, Platelet Reactivity, and the Risk of Adverse Events After Percutaneous Coronary Intervention (From the ADAPT-DES Study).

Hypertension is associated with vascular and endothelial dysfunction that may result in a greater propensity for reactive platelets to cause thrombosis. We sought to assess whether the risk of major adverse cardiac events (MACE) after percutaneous coronary intervention (PCI) in patients with on-clopidogrel residual high platelet reactivity (HPR) varies in patients with versus without hypertension. Assessment of dual antiplatelet therapy with drug eluting stents (ADAPT-DES) was a prospective, multicenter registry of patients successfully treated with coronary drug-eluting stents (DES). HPR was defined as P2Y12 reaction units (PRU) >208, as assessed by the VerifyNow point-of-care assay. Multivariable Cox proportional hazards regression was used to assess whether the adjusted association between HPR and 2-year risk of MACE (cardiac death, myocardial infarction [MI], or stent thrombosis) was different in patients with versus without hypertension. A total of 6833 of 8582 patients (79.6%) had a history of hypertension. Patients with compared with those without hypertension were older, more likely to have other cardiovascular risk factors, and had higher PRU (190.1 ± 97.3 vs 179.5 ± 94.3; p <0.0001). Patients with hypertension had significantly higher 2-year rates of MACE (7.0% vs 4.4%, p <0.001), all-cause death (4.2% vs 2.5%, p = 0.001), and MI (5.2% vs 3.2%, p <0.001), and had nominally higher rates of stent thrombosis (1.0% vs 0.5%, p = 0.059). A significant interaction was present between hypertension and HPR regarding 2-year MACE risk (adjusted hazard ratio for HPR vs no HPR 1.38, 95% confidence interval 1.14 to 1.68 for patients with hypertension vs 0.81, 95% confidence interval 0.50 to 1.33 for patients without hypertension, p = 0.046). In conclusion, following successful PCI with DES, 2-year MACE rates are increased in patients with both hypertension and residual HPR on clopidogrel. HPR had a greater effect on the risk of adverse events among patients with versus without hypertension.

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.

Adverse events in patients with high platelet reactivity following successful chronic total occlusion PCI: The Assessment of Dual AntiPlatelet Therapy with Drug-Eluting Stents (ADAPT-DES) study.

BACKGROUND: Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) typically requires a greater number of stents and longer stent length than non-CTO PCI, placing these patients at greater risk for adverse ischemic events. We sought to determine whether the association between high platelet reactivity (HPR) and the risk of ischemic events is stronger after CTO than non-CTO PCI. METHODS: Patients undergoing successful PCI in the multicenter ADAPT-DES study were stratified according to whether they underwent PCI of a CTO. HPR was defined as VerifyNow platelet reaction units >208. The study primary endpoint was the 2-year risk target vessel failure ([TVF] defined as cardiac death, myocardial infarction, or target lesion revascularization). RESULTS: CTO PCI was performed in 400 of 8448 patients. HPR was present in 34.5% of CTO PCI patients and 43.1% of non-CTO PCI patients (P = .0007). Patients undergoing CTO PCI with versus without HPR had significantly higher 2-year rates of TVF (15.0% versus 8.3%, P = .04) without significant differences in bleeding. HPR was an independent predictor of 2-year TVF (adjusted HR 1.16, 95% CI 1.02-1.34, P = .03) whereas CTO PCI was not (adjusted HR 0.89, 95% CI 0.65-1.22, P = .48). There was a significant interaction between CTO versus non-CTO PCI and PRU as a continuous variable for 2-year TVF (Pinteraction = 0.02). CONCLUSIONS: In ADAPT-DES, HPR was associated with an increased 2-year risk of TVF after PCI, an association that was at least as strong after CTO PCI compared with non-CTO PCI.

The Implications of Acute Clinical Care Responsibilities on the Contemporary Practice of Interventional Cardiology.

The responsibilities of the interventional cardiologist (IC) have evolved in contemporary practice to include substantial acute care clinical duties outside of the cardiac catheterization laboratory. In particular, the IC has assumed a central role in the global management of myocardial infarction and other acute coronary syndromes in the intensive care unit and beyond. These duties have expanded to include many nonprocedural tasks. The Interventional Section Leadership Council (ISLC) of the American College of Cardiology (ACC) therefore recommends: 1) these implications should be directly considered in the ACC's future planning and policy statements concerning manpower, competence, education, and reimbursement; 2) the development of an acute care cardiology subspecialty should be undertaken; 3) steps should be taken to adjust the number of ICs primarily on the basis of optimizing procedural volume and quality; and 4) the annual number of coronary interventions performed should not solely define competence in the future, but should include the performance of acute cardiology responsibilities.

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.

Relationship Between Intravascular Ultrasound Guidance and Clinical Outcomes After Drug-Eluting Stents.

Background In the large-scale ADAPT-DES study (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents), drug-eluting stent implantation with intravascular ultrasound (IVUS) guidance was associated with a reduction in 1-year rates of stent thrombosis, myocardial infarction (MI), and major adverse cardiac events (cardiac death, MI, or stent thrombosis) compared with angiography guidance alone. We assessed whether the benefits of IVUS guidance were maintained, reduced, or increased at 2 years. Methods and Results ADAPT-DES was a prospective, multicenter, nonrandomized all-comers study of 8582 consecutive patients at 11 US and German sites designed to determine the frequency, timing, and correlates of adverse events after drug-eluting stents. Propensity-adjusted multivariable analysis was performed to examine the impact of IVUS guidance on 2-year outcomes. IVUS guidance (n=3361; 39%) compared with angiography guidance (n=5221; 61%) was associated with reduced 2-year adjudicated rates of (1) major adverse cardiac events (cardiac death, MI, or stent thrombosis; 4.9% versus 7.5%; adjusted hazard ratio, 0.72; 95% CI, 0.59-0.89; P=0.003), (2) definite/probable stent thrombosis (0.55% versus 1.16%; adjusted hazard ratio, 0.40; 95% CI, 0.22-0.73; P=0.003), and (3) MI (3.5% versus 5.6%; adjusted hazard ratio, 0.65; 95% CI, 0.51-0.83; P=0.0006). By landmark analysis, IVUS guidance compared with angiography guidance was also associated with significantly reduced rates of major adverse cardiac events, MI, stent thrombosis, and clinically driven target lesion revascularization between 1 and 2 years after drug-eluting stent implantation. The number needed to treat with IVUS guidance to prevent 1 major adverse cardiac event was reduced from 64 (42-137) at 1 year to 41 (29-69) at 2 years. Conclusions In ADAPT-DES, the early improvement in event-free survival after drug-eluting stent implantation with IVUS guidance compared with angiography guidance was further increased with longer term follow-up to 2 years. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT00638794.

Prediction of Ischemic and Bleeding Events Using the Dual Antiplatelet Therapy Score in an Unrestricted Percutaneous Coronary Intervention Population.

BACKGROUND: The dual antiplatelet therapy (DAPT) risk score was developed from the DAPT trial to inform the optimal duration of DAPT after percutaneous coronary intervention. We assessed the performance of the DAPT score in the ADAPT-DES (Assessment of Dual AntiPlatelet Therapy with drug-eluting stents) all-comers registry and tested the utility of additional predictors of adverse events. METHODS AND RESULTS: Outcomes between 1 and 2 years were examined according to DAPT score ≥2 versus <2, adjusted for DAPT continuation as a time-dependent variable. To assess the incremental utility of variables not included in the DAPT score, baseline high platelet reactivity was added to the ischemia model, and high platelet reactivity, baseline hemoglobin, and warfarin use 1 year after percutaneous coronary intervention were added to the bleeding model. Among 8582 patients enrolled in ADAPT-DES, 5397 were event-free after 1 year. Between 1 and 2 years, ischemic (myocardial infarction or stent thrombosis) and bleeding events occurred in 75 (1.5%) and 124 (2.3%) patients, respectively. Patients with higher DAPT scores (≥2 versus <2) had higher rates of myocardial infarction or stent thrombosis (1.9% versus 1.1%; P=0.01) and similar rates of bleeding (2.2% versus 2.4%, respectively; P=0.79). For the prediction of myocardial infarction or stent thrombosis, bleeding and death, DAPT score ≥2 had sensitivities of 57%, 41%, and 56%, respectively; specificities of 58%, 57%, and 58%, respectively; positive predictive values of 1.9%, 2.2%, and 2.1%, respectively; and negative predictive values of 99%, 98%, and 99%, respectively. Addition of baseline high platelet reactivity to the DAPT score did not improve discrimination for ischemic events. Addition of high platelet reactivity and 2 other bleeding covariates to the DAPT score marginally improved discrimination. CONCLUSIONS: In ADAPT-DES, the DAPT score was predictive of ischemic events between 1 and 2 years after drug-eluting stents. Prediction of bleeding improved marginally after addition of variables not incorporated in the DAPT score.