A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device for the Treatment of Pulmonary Embolism (ENGULF).

Background: Despite advances in therapy options, pulmonary embolism (PE) continues to carry a high risk of mortality and morbidity. Currently, therapeutic options are limited with only 2 US Food and Drug Administration-cleared catheter-based embolectomy devices approved for the treatment of intermediate-risk PE. The novel Helo PE thrombectomy catheter (Endovascular Engineering, Inc) has a flexible and collapsible funnel with an internal agitator for a dual mechanism of treatment for acute PE. We sought to investigate the safety and feasibility of the novel Helo PE thrombectomy catheter in intermediate-risk PE. Methods: A prospective, single-arm feasibility study evaluating the Helo PE catheter was performed in patients presenting with intermediate-risk PE. Patients underwent preprocedural and postprocedural computed tomography angiography. Primary efficacy was the difference in preprocedural to postprocedural right ventricle/left ventricle (RV/LV) ratio. Primary and secondary safety outcomes were all-cause mortality, major life-threatening bleeding, device-related serious adverse events, pulmonary or cardiac injury, and clinical decompensation at 48 hours postprocedure and at 30 days. Results: A total of 25 patients from 8 centers were consented and included in the analysis. Preprocedural computed tomography angiography revealed an RV/LV ratio of 1.53 ± 0.27. All patients underwent a successful thrombectomy procedure. Postprocedure, the RV/LV ratio was reduced to 1.15 ± 0.18, translating into a 23.2 ± 12.81% decrease from baseline. No patients underwent adjunctive thrombolysis. Two patients had adjunctive catheter-directed embolectomy with an alternative device. Two patients had postprocedural anemia requiring transfusion but did not meet criteria for major life-threatening bleeding by VARC-2 criteria. There were no major adverse events including no deaths, major bleeding, pulmonary injury, or vascular complications at 48 hours or 30 days post procedure. Conclusions: In this multicenter first-in-human study, use of the Helo PE thrombectomy catheter was feasible and safe for the treatment of acute PE.

Barriers and facilitators to interhospital transfer of acute pulmonary embolism: An inductive qualitative analysis.

Background: Interhospital transfer (IHT) of patients with acute life-threatening pulmonary embolism (PE) is necessary to facilitate specialized care and access to advanced therapies. Our goal was to understand what barriers and facilitators may exist during this transfer process from the perspective of both receiving and referring physicians. Methods: This qualitative descriptive study explored physician experience taking care of patients with life threatening PE. Subject matter expert physicians across several different specialties from academic and community United States hospitals participated in qualitative semi-structured interviews. Interview transcripts were subsequently analyzed using inductive qualitative description approach. Results: Four major themes were identified as barriers that impede IHT among patients with life threatening PE. Inefficient communication which mainly pertained to difficulty when multiple points of contact were required to complete a transfer. Subjectivity in the indication for transfer which highlighted the importance of physicians understanding how to use standardized risk stratification tools and to properly triage these patients. Delays in data acquisition were identified in regards to both obtaining clinical information and imaging in a timely fashion. Operation barriers which included difficulty finding available beds for transfer and poor weather conditions inhibiting transportation. In contrast, two main facilitators to transfer were identified: good communication and reliance on colleagues and dedicated team for transferring and treating PE patients. Conclusion: The most prominent themes identified as barriers to IHT for patients with acute life-threatening PE were: (1) inefficient communication, (2) subjectivity in the indication for transfer, (3) delays in data acquisition (imaging or clinical), and (4) operational barriers. Themes identified as facilitators that enable the transfer of patients were: (1) good communication and (2) a dedicated transfer team. The themes presented in our study are useful in identifying opportunities to optimize the IHT of patients with acute PE and improve patient care. These opportunities include instituting educational programs, streamlining the transfer process, and formulating a consensus statement to serve as a guideline regarding IHT of patients with acute PE.

Known Unknowns in the Contemporary Management of High-Risk Pulmonary Embolism: What Do the Guidelines Tell Us.

Pulmonary embolism (PE) is a life-threatening condition with increasing hospital admissions. Prompt identification and treatment of PE patients with hemodynamic collapse are essential. Conflicting recommendations and weak evidence hinder effective management of PE, resulting in unchanged mortality rates despite advancements in therapies. Current risk stratification lacks granularity, necessitating a more detailed classification to guide treatment, predict outcomes, and improve patient selection for clinical trials. This article reviews clinical practice guidelines from major North American and European societies, emphasizing the need for more research and guidance to improve mortality and morbidity outcomes in PE.

Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Lesions: Long-Term Sex-Specific Outcomes.

Background: Intravascular lithotripsy (IVL) for calcified lesion preparation prior to drug-eluting stent placement has high procedural success and safety, especially in women, whereas other atheroablative approaches are associated with increased procedural complications. We sought to investigate long-term sex-based outcomes of IVL-facilitated stenting. Methods: We performed a patient-level pooled analysis of the single-arm Disrupt CAD III and IV studies. Patient baseline, procedural characteristics, and outcomes were examined according to sex at 30 days and 1 year. The primary end point was major adverse cardiac events (a composite of cardiac death, all myocardial infarction, or target vessel revascularization). Target lesion failure was defined as cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. Results: A total of 448 patients, 106 (24%) women, were included. Women were older and less likely to be smokers. Women had smaller reference vessel diameters (2.8 mm vs 3.1 mm), shorter lesion length (23.6 mm vs 27.1 mm), and shorter total calcified length (44.4 mm vs 49.3 mm) compared with men. Post-IVL angiographic outcomes and complications were similar between women and men. At 1 year, major adverse cardiac event rates (12.3% vs 13.2%, P = .52) were not different between women and men. There were no differences between women and men (10.4% vs 11.2%; P = .43) in target lesion failure at 1 year. Conclusions: Use of IVL in the treatment of severely calcified lesions is associated with low rates of adverse clinical events and with similar safety and effectiveness in women and men at 1 year.

Advocacy 101 for Interventional Cardiologists: A Society for Cardiovascular Angiography & Interventions Policy Statement.

Advocacy is a core mission of the Society for Cardiovascular Angiography & Interventions (SCAI). SCAI advocates on behalf of interventional cardiologists and our patients. This document provides foundational information and a toolkit for grassroots advocacy by interventional cardiologists. The first half of the document summarizes how health care laws are made, how medical devices are approved, and how procedure reimbursement is determined. The second half of the document is a playbook of advocacy strategies: legislative advocacy, judicial advocacy, advocacy with regulators and payors, advocacy in the media, and participation in SCAI advocacy initiatives, such as the Government Relations Committee and SCAI Political Action Committee. Equipped with this toolbox, interventional cardiologists must increase our advocacy activities with government, payors, and industry.

The Effect of Geographic Cohorting of Inpatient Teaching Services on Patient Outcomes and Resident Experience.

BACKGROUND: Geographic cohorting is a hospital admission structure in which every patient on a given physician team is admitted to a dedicated hospital unit. Little is known about the long-term impact of this admission structure on patient outcomes and resident satisfaction. OBJECTIVE: To evaluate the effect of geographic cohorting on patient outcomes and resident satisfaction among inpatient internal medicine teaching services within an academic hospital. DESIGN AND INTERVENTION: We conducted an interrupted time series analysis examining patient outcomes before and after the transition to geographic cohorting of our 3 inpatient teaching services within a 520-bed academic hospital in November 2017. The study observation period spanned from January 2017 to October 2018, allowing for a 2-month run-in period (November-December 2017). PARTICIPANTS: We included patients discharged from the inpatient teaching teams during the study period. We excluded patients admitted to the ICU and observation admissions. MAIN MEASURES: Primary outcome was 6-month mortality adjusted for patient age, sex, race, insurance status, and Charlson Comorbidity Index (CCI) analyzed using a linear mixed effects model. Secondary outcomes included hospital length of stay (LOS), 7-day and 30-day readmission rate, Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores, and resident evaluations of the rotation. KEY RESULTS: During the observation period, 1720 patients (mean age 64, 53% female, 56% white, 62% Medicare-insured, mean CCI 1.57) were eligible for inclusion in the final adjusted model. We did not detect a significant change in 6-month mortality, LOS, and 7-day or 30-day readmission rates. HCAHPS scores remained unchanged (77 to 80% top box, P = 0.19), while resident evaluations of the rotation significantly improved (mean overall score 3.7 to 4.0, P = 0.03). CONCLUSIONS: Geographic cohorting was associated with increased resident satisfaction while achieving comparable patient outcomes to those of traditional hospital admitting models.

Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Lesions: 1-Year Results From the Disrupt CAD III Study.

Background: Coronary calcification impairs stent delivery and optimal expansion, a significant predictor of subsequent stent thrombosis and restenosis. Current calcium ablative technologies may be limited by guidewire bias and periprocedural complications. Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcium, enhance vessel compliance, and optimize stent deployment. The Disrupt CAD III study demonstrated high (92.4%) procedural success and low (7.8%) 30-day major adverse cardiac event (MACE) rates following IVL, but longer term follow-up is required to determine the durability of clinical benefit and the late impact of optimized stent implantation associated with IVL. This analysis evaluates 1-year outcomes from the Disrupt CAD III study. Methods: Disrupt CAD III (NCT03595176) was a prospective, single-arm approval study designed to assess the safety and effectiveness of IVL as an adjunct to coronary stenting in de novo, severely calcified coronary lesions (n = 384). MACE was defined as the composite of cardiac death, myocardial infarction (MI), or ischemia-driven target vessel revascularization; target lesion failure was defined as cardiac death, MI, or ischemia-driven target lesion revascularization (ID-TLR). Results: At 1 year, MACE occurred in 13.8% of patients (cardiac death: 1.1%, MI: 10.5%, ischemia-driven target vessel revascularization: 6.0%) and target lesion failure occurred in 11.9% (ID-TLR: 4.3%), both driven by non-Q-wave MI (9.2%). Stent thrombosis (definite or probable) occurred in 1.1% of patients (including 1 event [0.3%] beyond 30 â€‹days). Conclusions: Disrupt CAD III represents the largest long-term (1-year) analysis of coronary IVL to date. IVL treatment prior to coronary stent implantation in severely calcified lesions was associated with low 1-year rates of MACE, ID-TLR, and stent thrombosis.

Sex-Specific Outcomes After Coronary Intravascular Lithotripsy: A Patient-Level Analysis of the Disrupt CAD Studies.

Background: Coronary artery calcification increases the procedural complexity of percutaneous coronary intervention and is associated with worse outcomes, especially in women. Intravascular lithotripsy (IVL) has been demonstrated to be safe and effective for vessel preparation in severely calcified stenotic lesions before stent implantation. Sex-based outcomes of IVL-facilitated stenting have not been defined. Methods: We performed a patient-level pooled analysis of the 4 prospective, single-arm Disrupt CAD studies that evaluated the safety and efficacy of IVL-facilitated stenting. Patient baseline and procedural characteristics and clinical outcomes were examined based on sex. The primary safety end point was 30-day major adverse cardiovascular events, defined as the composite of cardiac death, myocardial infarction, or target vessel revascularization. The primary efficacy end point was procedural success, defined as stent delivery with residual in-stent stenosis ≤30% without in-hospital major adverse cardiovascular events. Results: A total of 628 patients were included, of which 144 (22.9%) were women. Women were older (P < .001) and more likely to have hyperlipidemia (P = .03), renal insufficiency (P = .05), and prior myocardial infarction (P = .05). Women had smaller mean reference vessel diameter (2.7 â€‹ ± â€‹0.4 â€‹mm vs 3.0 â€‹ ± â€‹0.5 â€‹mm, P < .001), shorter lesion length (22.4 â€‹ ± â€‹10.3 â€‹mm vs 25.0 â€‹ ± â€‹11.7 â€‹mm, P = .01), and less side branch involvement (22.9% vs 32.4%, P = .03). Severe coronary calcification defined by angiography, stent delivery success, lesion predilatation, post-IVL dilatation, and poststent dilatation was similar between groups. There were no significant differences between women and men in the primary safety end point (8.3% vs 7.1%, P = .61; adjusted odds ratio 1.66; 95% confidence interval 0.78, 3.34; P = .17) or the primary efficacy end point (91.7% vs 92.6%, P = .72; adjusted odds ratio 0.58; 95% confidence interval 0.29, 1.24; P = .15). Post-IVL serious angiographic complications (flow-limiting dissection, perforation, abrupt closure, slow flow, no reflow) were similar for women and men (1.6% vs 2.3%, P = .75). Conclusions: Despite more comorbidities and smaller vessel size, IVL-facilitated stenting of severely calcified lesions achieves similar safety and efficacy in women and men.

SCAI Position Statement on Best Practices for Percutaneous Axillary Arterial Access and Training.

Axillary artery access has become increasingly widespread as an alternative to the femoral route for large-bore transcatheter aortic valve replacement (TAVR), endovascular aortic repair (EVAR), and mechanical circulatory support (MCS) procedures. Advantages of percutaneous access include avoidance of a surgical incision, general anesthesia, and conduit graft infection. This statement aims to review the anatomic considerations and risks for percutaneous axillary artery access, suggest best practices for access techniques, hemostasis/closure strategies, and complication management, and recommend options for training and privileging.

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.

Grit Does Not Predict Burnout among First-Year Internal Medicine Residents.

OBJECTIVES: Grit, defined as passion and perseverance for long-term goals, has been associated with the avoidance of burnout among residents in a number of specialties. We aimed to evaluate the relationship between grit and burnout among first-year Internal Medicine residents. METHODS: During the 2018-2019 academic year, the authors recruited 75 first-year Internal Medicine residents within a large academic program to complete the Short Grit Scale (Grit-S) and the Maslach Burnout Inventory General Survey (MBI-GS) at baseline and after 6 and 12 months. The primary outcome was the association between baseline Grit-S and MBI-GS scores within the domains of emotional exhaustion (EE) or cynicism (CYN) over time using linear mixed models. Secondary outcomes included the association between grit and high burnout at 6 or 12 months, grit and persistently high burnout, and the association of baseline high burnout with later high scores at 6 and 12 months using logistic regression models and trends in grit over time using repeated-measures analysis of variance. RESULTS: A total of 53 of 75 (71%) first-year residents completed the Grit-S and MBI-GS at baseline and at least one other time point. There was no association between grit and EE (P = 0.44) or CYN (P = 0.61) burnout domain scores. High baseline EE and high baseline CYN significantly increased the odds of later high burnout scores within each domain (EE odds ratio 9.66, 95% confidence interval 1.16-80.83; CYN odds ratio 13.37, 95% confidence interval 1.52-117.75). Grit scores and professional efficacy scores remained stable throughout the year (P = 0.15 and 0.46, respectively), while EE and CYN significantly increased (both P < 0.01). CONCLUSIONS: In this single-center study, grit was not associated with burnout among first-year Internal Medicine residents; however, our findings highlight the value of baseline burnout scores in helping to identify first-year residents who may be at higher risk of later burnout.

Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies.

OBJECTIVES: The aim of this pooled analysis was to assess the cumulative safety and effectiveness of coronary intravascular lithotripsy (IVL). BACKGROUND: The clinical outcomes of IVL to optimize target lesion preparation in severely calcified de novo coronary stenoses have been examined in 4 prospective studies (Disrupt CAD I [NCT02650128], Disrupt CAD II [NCT03328949], Disrupt CAD III [NCT03595176], and Disrupt CAD IV [NCT04151628]). METHODS: Patient data were pooled from the Disrupt CAD studies, which shared uniform study criteria, endpoint definitions and adjudication, and procedural follow-up. The primary safety endpoint was freedom from major adverse cardiovascular events (composite of cardiac death, all myocardial infarction, or target vessel revascularization) at 30 days. The primary effectiveness endpoint was procedural success, defined as stent delivery with a residual stenosis ≤30% by quantitative coronary angiography without in-hospital major adverse cardiovascular events. Secondary outcomes included serious angiographic complications, target lesion failure, cardiac death, and stent thrombosis at 30 days. RESULTS: Between December 2015 and April 2020, 628 patients were enrolled at 72 sites from 12 countries. Presence of severe calcification was confirmed in 97.0% of target lesions with an average calcified segment length of 41.5 ± 20.0 mm. The primary safety and effectiveness endpoints were achieved in 92.7% and 92.4% of patients, respectively. At 30 days, the rates of target lesion failure, cardiac death, and stent thrombosis were 7.2%, 0.5%, and 0.8%. Rates of post-IVL and final serious angiographic complications were 2.1% and 0.3%, with no IVL-associated perforations, abrupt closure, or episodes of no reflow. CONCLUSIONS: In the largest cohort of patients treated with coronary IVL assessed to date, coronary IVL safely facilitated successful stent implantation in severely calcified coronary lesions with a high rate of procedural success.

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.