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.

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.

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.

Achieving timely percutaneous reperfusion for rural ST-elevation myocardial infarction patients by direct transport to an urban PCI-hospital.

BACKGROUNDS: ST-elevation myocardial infarction (STEMI) guidelines recommend reperfusion by primary percutaneous coronary intervention (PCI) ≤ 90 min from time of first medical contact (FMC). This strategy is challenging in rural areas lacking a nearby PCI-capable hospital. Recommended reperfusion times can be achieved for STEMI patients presenting in rural areas without a nearby PCI-capable hospital by ground transportation to a central PCI-capable hospital by use of protocol-driven emergency medical service (EMS) STEMI field triage protocol. METHODS: Sixty STEMI patients directly transported by EMS from three rural counties (Nassau, Camden and Charlton Counties) within a 50-mile radius of University of Florida Health-Jacksonville (UFHJ) from 01/01/2009 to 12/31/2013 were identified from its PCI registry. The STEMI field triage protocol incorporated three elements: (1) a cooperative agreement between each of the rural emergency medical service (EMS) agency and UFHJ; (2) performance of a pre-hospital ECG to facilitate STEMI identification and laboratory activation; and (3) direct transfer by ground transportation to the UFHJ cardiac catheterization laboratory. FMC-to-device (FMC2D), door-to-device (D2D), and transit times, the day of week, time of day, and EMS shift times were recorded, and odds ratio (OR) of achieving FMC2D times was calculated. RESULTS: FMC2D times were shorter for in-state STEMIs (81 ± 17 vs. 87 ± 19 min), but D2D times were similar (37 ± 18 vs. 39 ± 21 min). FMC2D ≤ 90 min were achieved in 82.7% in-state STEMIs compared to 52.2% for out-of-state STEMIs (OR = 4.4, 95% CI: 1.24-15.57; P = 0.018). FMC2D times were homogenous after adjusting for weekday vs. weekend, EMS shift times. Nine patients did not meet FMC2D ≤ 90 min. Six were within 10 min of target; all patient achieved FMC2D ≤ 120 min. CONCLUSIONS: Guideline-compliant FMC2D ≤ 90 min is achievable for rural STEMI patients within a 50 mile radius of a PCI-capable hospital by use of protocol-driven EMS ground transportation. As all patients achieved a FMC2D time ≤ 120 min, bypass of non-PCI capable hospitals may be reasonable in this situation.

Operator radiation exposure and physical discomfort during a right versus left radial approach for coronary interventions: a randomized evaluation.

OBJECTIVES: This study sought to assess radiation exposure and operator discomfort when using left radial approach (LRA) versus right radial approach (RRA) for coronary diagnostic and percutaneous interventions. BACKGROUND: The transradial approach is increasingly being adopted as the preferred vascular access for coronary interventions. Currently, most are performed using an RRA. This is in part due to the perceived increased operator physical discomforts as well increased radiation exposure with an LRA. METHODS: One hundred patients were randomized to an LRA or RRA. Each operator (n = 5) had an independent randomization process, and patients were stratified according to obesity status. Operator radiation was measured using separate sets of radiation dosimeter badges placed externally on the head and thyroid and internally on the sternum. Operator physical discomfort was surveyed at 2 time points: during vascular access and at the end of the procedure. Moderate to severe physical discomfort was defined as a score of >4. RESULTS: There were no significant differences in baseline and procedural variables between groups. There was a significant increase in external radiation exposure using the RRA versus LRA (head: median: 6.12 [interquartile range (IQR): 2.6 to 16.6] mRems vs. median: 12.0 [IQR: 6.4 to 22.0] mRems, p = 0.02; thyroid: median: 10.10 [IQR: 4.3 to 25] mRems vs. median: 18.70 [IQR: 11.0 to 38] mRems, p = 0.001). More discomfort was reported with the LRA during access (LRA: 22% vs. RRA: 4%; p = 0.017), but not during the procedure (LRA: 10.0% vs. RRA: 4.0%, p = 0.43). This difference was almost entirely noted in obese patients (LRA: 30.0% vs. RRA: 3.7%, p = 0.005). CONCLUSIONS: LRA is as effective as RRA, showing a safer profile with decreased radiation exposure to the operator, at the expense of more operator discomfort only during vascular access and limited to obese patients.

An algorithm for identification of ST-elevation myocardial infarction patients by emergency medicine services.

OBJECTIVE: ST-elevation myocardial infarction (STEMI) identification by emergency medicine services (EMS) leading to pre-hospital catheterization laboratory (CL) activation shortens ischemic time and improves outcomes. We examined the incremental value of addition of a screening clinical tool (CT), containing clinical information and a Zoll electrocardiogram (ECG)-resident STEMI identification program (ZI) to ZI alone. METHODS: All EMS-performed and ZI-analyzed ECGs transmitted to a percutaneous coronary intervention hospital from October 2009 to January 2011 were reviewed for diagnostic accuracy. ZI performance was also compared to ECG interpretations by 2 experienced readers The CT was then retrospectively applied to determine the incremental benefit above the ZI alone. RESULTS: ST-elevation myocardial infarction was confirmed in 23 (7.5%) of 305 patients. ZI was positive in 37 (12.1%): sensitivity: 95.6% and specificity: 94.6%, positive predictive value (PPV), 59.5%, negative predictive value (NPV), 99.6%, and accuracy of 93.8%. Moderate agreement was observed among the readers and ZI. CT criteria for CL activation were met in 24 (7.8%): 20 (83.3%) were confirmed STEMIs: sensitivity: 86.9%, specificity: 98.5%, a PPV: 83.3%, and NPV: 98.6%, accuracy of 97.7%. CT + ZI increased PPV (P<0.05) and specificity (P<0.003) by reducing false positive STEMI identifications from 15 (4.9%) to 4 (1.3%). CONCLUSIONS: In an urban cohort of all EMS transmitted ECGs, ZI has high sensitivity and specificity for STEMI identification. Whereas the PPV was low, reflecting both low STEMI prevalence and presence of STEMI-mimics, the NPV was very high. These findings suggest that a simplified CT combined with computer STEMI interpretation can identify patients for pre-hospital CL activation. Confirmation of these results could improve the design of STEMI care systems.

Effects of pioglitazone on platelet P2Y12-mediated signalling in clopidogrel-treated patients with type 2 diabetes mellitus.

Patients with type 2 diabetes mellitus (T2DM) have impaired clopidogrel-induced antiplatelet effects, which may be in part attributed to their reduced sensitivity to insulin and consequently, results in upregulation of the P2Y12 signalling pathway. It has been hypothesised that insulin sensitising strategies may enhance clopidogrel-mediated P2Y12 inhibitory effects. The aim of this pilot pharmacodynamics (PD) study was to assess the impact of pioglitazone on clopidogrel-mediated P2Y12 inhibitory effects in patients with T2DM. This was a prospective, randomised, double-blind, placebo-controlled, cross-over PD study. Patients with T2DM and stable coronary artery disease on maintenance aspirin and clopidogrel were randomised to receive either pioglitazone 30 mg or matching placebo daily for 14 days. PD assessments were measured at baseline, 14 days after randomisation, at the end of the wash-out period, and 14 days after cross-over. The primary endpoint measure was maximal platelet aggregation (MPA) to 20 µM adenosine diphosphate (ADP) as assessed by light transmittance aggregometry (LTA). Flow cytometric analysis of vasodilator-stimulated phosphoprotein phosphorylation (VASP-PRI), and VerifyNow P2Y12 testing were also performed. A total of 15 randomised patients completed the study. MPA to 20 µM ADP (primary endpoint) was not significantly different with pioglitazone compared with placebo (49.53 ± 4.76 vs. 52.52 ± 3.89%; p = 0.594). Similarly, other PD measures did not differ significantly between the groups. In conclusion, in patients with T2DM on maintenance aspirin and clopidogrel therapy, the adjunctive use of pioglitazone does not result in enhanced inhibition of platelet P2Y12 mediated signalling.

Pharmacodynamic effects of prasugrel dosing regimens in patients on maintenance prasugrel therapy: results of a prospective randomized study.

OBJECTIVES: The purpose of this study is to assess the pharmacodynamic effects of different prasugrel dosing regimens in patients on maintenance prasugrel therapy. BACKGROUND: There are a growing number of patients on chronic prasugrel therapy regimens, leading to questions about the dosing regimen of prasugrel to administer if percutaneous coronary intervention is required. METHODS: This is a prospective pharmacodynamic study in patients (n = 64) receiving maintenance prasugrel therapy who were randomly allocated to a 10 mg, 30 mg, or 60 mg dose of prasugrel. Pharmacodynamic assessments using multiple assays were conducted at 3 timepoints (baseline and 1 h and 4 h after dosing). RESULTS: Intragroup comparisons showed that a 60 mg dose reduced the platelet reactivity index (PRI) after 1 h (p = 0.004) and 4 h (p < 0.001, primary endpoint; p = 0.002 between 1 h and 4 h). A 30 mg dose also reduced PRI levels at 1 h (p = 0.006) and 4 h (p < 0.001; p = 0.044 between 1 h and 4 h). A 10 mg dose was associated with modest pharmacodynamic effects. Intragroup comparisons showed similar findings with VerifyNow-P2Y12 and light transmission aggregometry. Intergroup comparisons showed that a 60 mg dose achieved lower PRI levels than 30 mg at 4 h (p = 0.05), and a numerical trend toward better pharmacodynamic effects at 1 h (p = 0.171). Intergroup comparisons were similar with VerifyNow-P2Y12, but not light transmission aggregometry. CONCLUSIONS: For patients on maintenance prasugrel therapy, a 60 mg dosing strategy is associated with faster and higher platelet inhibition compared with lower doses, as assessed by P2Y(12) specific assays. (Impact of Prasugrel Re-load on Platelet Aggregation in Patients on Chronic Prasugrel Therapy; NCT01201772).

Impact of adjunctive cilostazol therapy on platelet function profiles in patients with and without diabetes mellitus on aspirin and clopidogrel therapy.

Cilostazol is a platelet inhibitor which when added to aspirin and clopidogrel has shown to reduce the risk of recurrent ischaemic events without an increase in bleeding. These clinical benefits have shown to be more pronounced in patients with diabetes mellitus (DM). However, it remains unknown whether cilostazol exerts different pharmacodynamic effects in patients with and without DM. This was a randomised, double-blind, placebo-controlled, cross-over pharmacodynamic study comparing platelet function in patients with and without DM on aspirin and clopidogrel therapy. Patients (n=111) were randomly assigned to either cilostazol 100 mg or placebo twice daily for 14 days and afterwards crossed-over treatment for another 14 days. Platelet function was performed at baseline, 14 days post-randomisation, and 14 days post-cross-over. Functional testing to assess P2Y12 signalling included flow cytometric analysis of phosphorylation status of vasodilator-stimulated phosphoprotein measured by P2Y12 reactivity index (PRI), light transmittance aggregometry and VerifyNow. Thrombin generation processes were also studied using thrombelastography. Significantly lower PRI values were observed following treatment with cilostazol compared with placebo both in DM and non-DM groups (p < 0.0001). The absolute between-treatment differences of PRI between groups was a 35.1% lower in patients with DM (p=0.039). Similar results were obtained using all other functional measures assessing P2Y12 signalling. Thrombin generation was not affected by cilostazol. Cilostazol reduces platelet reactivity both in patients with and without DM, although these pharmacodynamic effects are enhanced in patients with DM. Despite the marked platelet inhibition, cilostazol does not alter thrombin-mediated haemostatic processes, which may explain its ischaemic benefit without the increased risk of bleeding.

A randomized study assessing the impact of cilostazol on platelet function profiles in patients with diabetes mellitus and coronary artery disease on dual antiplatelet therapy: results of the OPTIMUS-2 study.

AIMS: Patients with type 2 diabetes mellitus (T2DM) have reduced platelet inhibition compared with non-diabetics following P2Y(12) receptor blockade. Whether inhibition of P2Y(12) signalling can be enhanced by adjunctive treatment with cilostazol in T2DM patients is unknown. The aim of this pilot study was to assess the functional impact of cilostazol in T2DM patients on standard aspirin and clopidogrel treatment. METHODS AND RESULTS: This was a prospective, double-blind, double-dummy, placebo-controlled, randomized, cross-over platelet function study. T2DM patients on dual antiplatelet therapy were assigned to receive cilostazol 100 mg or placebo twice daily for 14 days and afterwards crossed-over treatment assignments for another 14 days. Platelet function was performed at three time points: at baseline, 14 days after randomization, and 14 days after treatment cross-over. The P2Y(12) reactivity index, determined through flow cytometric assessment of the phosphorylation status of the vasodilator-stimulated phosphoprotein, was the primary endpoint measure. In addition to this flow cytometric evaluation, light transmittance aggregometry and VerifyNow testing were performed. A total of 25 T2DM patients were randomized; five patients discontinued treatment due to side effects. The P2Y(12) reactivity index was significantly lower following cilostazol treatment compared with placebo (36.3 +/- 20 vs. 59.9 +/- 16%; P = 0.0002). All other P2Y(12)-specific functional assessments showed enhanced inhibition of this signalling pathway following treatment with cilostazol. CONCLUSION: Adjunctive treatment with cilostazol in T2DM patients on standard dual antiplatelet therapy enhances inhibition of platelet P2Y(12) signalling.

Variable histological and ultrasonic characteristics of restenosis after drug-eluting stents.

Bare-metal stents have undergone intense pathological and clinical examination, but histological characterization of drug-eluting stent (DES) restenosis (ISR) remains unknown. We report a series of cases (n=6) with intravascular ultrasound (IVUS) and pathological examinations over 8 months after DES deployment. Tissue samples were obtained using atherectomy devices in 5 cases and a thrombectomy catheter in 1 case. Histology revealed not only smooth muscle cell proliferation, which correlated with homogeneous hypoechoic tissue by IVUS in one case, but also demonstrated delayed healing features such as organized fibrin deposition in 3 cases (one with homogeneous echolucent tissue by IVUS), macrophage and T-lymphocyte infiltration in others. IVUS appearance of ISR components varied from echolucent to echodense images. This report suggests a variable histological and IVUS pattern of ISR after DES implantation. Further investigations are necessary to define the potentially pro-thrombotic histological features of ISR after DES implantation, and the relationship between the molecular mechanisms of thrombosis and DES restenosis.

Heterogeneity of atherosclerotic plaque characteristics in human coronary artery disease: a three-dimensional intravascular ultrasound study.

OBJECTIVES: The objective of this study was to describe the intraplaque variability of coronary atherosclerosis in humans. BACKGROUND: Atherosclerosis is a heterogeneous process. The degree and patterns of intraplaque heterogeneity are not well described. This study uses 3D intravascular ultrasound (IVUS) to examine variability in individual atherosclerotic plaques in human coronary arteries. METHODS: IVUS images of 170 coronary plaques in 98 patients were evaluated. Each plaque was divided into proximal, middle, and distal sections. Quantitative and qualitative analyses were performed for each section using a dedicated 3D IVUS protocol. Intralesion heterogeneity was assessed between sections. RESULTS: Heterogeneity in composition was observed in most plaques (89%). The pattern of remodeling was heterogeneous in 23% of lesions. External elastic membrane (EEM) areas demonstrated an average percent deviation of 28.9% +/- 15.5%. Positive remodeling was associated with longer lesions (>> median length of 12.7 mm) (P = 0.031). Soft and calcific sections had a smaller mean EEM area (P = 0.034). Calcific lesions had a smaller mean lumen area (P = 0.027) and a greater percent plaque burden (PPB) (P = 0.001). Neither the location within the vessel or within the plaque was associated with plaque morphology. Greater qualitative heterogeneity was found in patients presenting with acute coronary syndrome (P < 0.001). CONCLUSIONS: Our results demonstrate a high degree of heterogeneity in composition and morphological features within individual atherosclerotic plaques in human coronary arteries. Intraplaque heterogeneity represents a challenge for imaging protocols correlating plaque features with cardiovascular events and for the development of future therapeutic options.

Effect of female partner age on pregnancy rates after vasectomy reversal.

OBJECTIVE: To determine the effect of female partner age on pregnancy rates after vasectomy reversal. DESIGN: Retrospective review. SETTING: Two academic infertility practices. PATIENT(S): Men undergoing vasectomy reversal and their partners. INTERVENTION(S): Microsurgical vasectomy reversal. MAIN OUTCOME MEASURE(S): Patency and pregnancy rates. RESULT(S): Two hundred ninety-four patients met the inclusion criteria. Groups were similar with regard to types of procedure performed (vasovasostomy or vasoepididymostomy), obstructive interval, female factors, number of repeat procedures, and quality of vasal fluid. Patency rates were 90%, 89%, 90%, 86%, and 83% for patients with female partners aged 20-24, 25-29, 30-34, 35-39, and 40+ years, respectively. Pregnancy rates were 67%, 52%, 57%, 54%, and 14% for patients with female partners aged 20-24, 25-29, 30-34, 35-39, and 40+ years, respectively. The pregnancy rate for couples with female partner aged 40 or older was lower than for those with the female partner aged 39 or younger (14% vs. 56%). CONCLUSION(S): Pregnancy rates for vasectomy reversal were good regardless of female age as long as the partner was 39 years old or younger. Pregnancy rates were lower if the female partner was 40 or more years old.

Secondary azoospermia after vasovasostomy.

OBJECTIVES: To determine the frequency of secondary azoospermia after microsurgical vasovasostomy and to determine what factors increase the risk of its occurrence. METHODS: We performed a retrospective review of three surgeons' experience. Patency was defined as the presence of sperm in at least one postoperative semen sample. Transient patency was defined as azoospermia or no motile sperm after previous documentation of motile sperm. RESULTS: A total of 242 patients underwent 245 procedures (233 bilateral, 12 unilateral). The mean patient age was 39.2 +/- 0.4 years (range 24 to 56), and the mean obstructive interval was 8.7 +/- 0.3 years (range 0.25 to 24). The patency rates were 91% (224 of 245, sperm present in the semen) and 86% (208 of 245, motile sperm present in the semen). The transient patency rates were 5.3% (13 of 245, presence of sperm, with subsequent azoospermia) and 2.9% (7 of 241, motile sperm in the semen, with subsequent azoospermia) at a follow-up of 9.0 +/- 0.7 months (range 1 to 60). Transient patency occurred at a mean of 9.7 +/- 2.3 months. A greater risk of transient patency was observed with unilateral cases than bilateral cases (3 of 12, 25% versus 10 of 233, 4.3%; P = 0.0196, Fisher's exact test), and the obstructive interval was shorter for patent than for transient patent cases (Mann-Whitney U test, P = 0.0458). CONCLUSIONS: The results of our study demonstrated that secondary azoospermia after vasovasostomy is rare. It is more common in unilateral cases and the obstructive interval for transiently patent cases is longer. Sperm cryopreservation, when motile sperm appear in the semen postoperatively, can circumvent the problem of secondary azoospermia, but most men will not need the frozen sperm.