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Recent advances in therapy and the promulgation of multidisciplinary pulmonary embolism teams show great promise to improve management and outcomes of acute pulmonary embolism (PE). However, the absence of randomized evidence and lack of consensus leads to tremendous variations in treatment and compromises the wide implementation of new innovations. Moreover, the changing landscape of health care, where quality, cost, and accountability are increasingly relevant, dictates that a broad spectrum of outcomes of care must be routinely monitored to fully capture the impact of modern PE treatment. We set out to standardize data collection in patients with PE undergoing evaluation and treatment, and thus establish the foundation for an expanding evidence base that will address gaps in evidence and inform future care for acute PE. To do so, >100 international PE thought leaders convened in Washington, DC, in April 2022 to form the Pulmonary Embolism Research Collaborative. Participants included physician experts, key members of the US Food and Drug Administration, patient representatives, and industry leaders. Recognizing the multidisciplinary nature of PE care, the Pulmonary Embolism Research Collaborative was created with representative experts from stakeholder medical subspecialties, including cardiology, pulmonology, vascular medicine, critical care, hematology, cardiac surgery, emergency medicine, hospital medicine, and pharmacology. A list of critical evidence gaps was composed with a matching comprehensive set of standardized data elements; these data points will provide a foundation for productive research, knowledge enhancement, and advancement of clinical care within the field of acute PE, and contribute to answering urgent unmet needs in PE management. Evidence produced through the Pulmonary Embolism Research Collaborative, as it is applied to data collection, promises to provide crucial knowledge that will ultimately produce a robust evidence base that will lead to standardization and harmonization of PE management and improved outcomes., Competing Interests: Dr Rosenfield reports consulting fees from Abbott Vascular, Boston Scientific, Contego, Imperative Care, Johnson & Johnson, Biosense Webster, Medtronic, Neptune Medical, and Philips; board membership for the PERT (Pulmonary Embolism Response Team) Consortium; and stock or stock options in Access Vascular, Althea Medical, Auxetics, Contego, Endospan, Imperative Care, Innova Vascular, InspireMD, JanaCare, Magneto, MedAlliance, Neptune Medical, Orchestra, Sealonix, Shockwave, Skydance, Summa Therapeutics, Thrombolex, Vantis Vascular, Vasorum, Viz.ai, and Vumedi. Dr Bowers reports consulting fees from Truvic, Inc, lecture fees from Janssen and Bristol Myers Squibb (BMS)-Pfizer, payment for expert testimony, and participation on Advisory Board of Truvic, Inc. Dr Barnett reports payment for expert testimony. Dr Davis reports travel support for attending the Pulmonary Embolism Research Collaborative meeting. Dr Giri reports research support from Boston Scientific, Inc, and Inari Medical; consulting fees from Boston Scientific, Inc, Cordis, and Abbott Vascular; support for attending meetings from Inari Medical; participation on an advisory board for Angiodynamics, Inc, and Boston Scientific, Inc; participation in leadership at Society for Cardiac Angiography and Intervention and the PERT Consortium; and stock or stock options in Endovascular Engineering. Dr Horowitz reports research support from Inari Medical; consultation and personal lecture fees from Inari Medical and Penumbra, Inc; and support for attending meetings from Inari Medical. Dr Keeling reports consulting fees from Angiodynamics, Inc, Penumbra, Inc, Viz.ai, and Dexcom. Dr Klok reports institutional research support from Bayer, Bristol Myers Squibb, Actelion, Boston Scientific, Inc, Leo Pharma, the Netherlands Organisation for Health Research and Development, the Dutch Thrombosis Association, the Dutch Heart Foundation, and the Horizon Europe program; service on the Board of the Rembrandt Institute of Cardiovascular Science; Chair of the Board of the Dutch Society of Vascular Medicine; nucleus member of the European Society of Cardiology work group on pulmonary circulation and RV function; nucleus member of ISTH SSC diagnostic and predictive variables; Chair of the Board of the Dutch Thrombosis Network; and medical lead, Anticoagulation Clinic Leiden. Dr Konstantinides reports personal and institutional consulting fees from Bayer AG, Daiichi-Sankyo, and Boston Scientific, Inc, and personal lecture fees from Bayer AG, Daiichi-Sankyo, Pfizer–Bristol Myers Squibb, and Boston Scientific, Inc. Dr Lookstein reports consulting fees from Penumbra, Inc, Boston Scientific, Inc, Medtronic, Cordis, Becton Dickinson, Abbott Vascular, Neptune Medical, Imperative Care, and Aidoc; payment for expert testimony; participation on advisory boards for Magneto, Boston Scientific, Inc, Medtronic, and Trireme; leadership roles at the PERT Consortium, Critical Limb Ischemia Global Society, and Society of Interventional Radiology; and stock or stock options in Imperative Vascular, Thrombolex, Innova Vascular, and Summa Vascular. Dr Moriarty reports research support from Angiodynamics, Inc, and Penumbra, Inc; consulting fees from Angiodynamics, Inc, Penumbra Inc, Inquis Medical, Innova Vascular, Boston Scientific Inc, Auxetics, and Retriever Medical; and participation on the data safety monitoring board for Penumbra, Inc. Dr Ní Áinle reports institutional research support from Sanofi, Daiichi-Sankyo, the Irish Health Research Board, Bayer, and Boston Scientific, Inc; patents pending for European Application No. 20166826.6; past member of World Thrombosis Day International Steering Committee; Director at Large and Member, International Network of Venous ThromboEmbolism Research Networks Council; Co-Director, InVite; Co-Founder and member of Executive Committee of Venous Thromboembolism Ireland; Advisory Committee for Human Medicines; member of “Preventing Venous Thromboembolism in Hospitals” Collaborative Advisory Group; Board Member, Thrombosis Ireland Patient Organization and Charity; and National Lead, Irish Venous Thromboembolism Patient Safety Programme. Dr Rosovsky reports research support from BMS and Janssen; consulting fees from Abbott, BMS, Dova, Inari Medical, Janssen, and Penumbra, Inc; participation on the data safety monitoring board for the Pepper Trial and Harvard Cancer Center; unpaid President-Elect of the PERT Consortium; and unpaid member of ASH Committee on Quality. Dr Secemsky reports research support from NIH/NHLBINIH/NHBLI K23HL150290, Food and Drug Administration, Becton-Dickinson, Boston Scientific, Inc, Cook Medical, Cardiovascular Systems Inc., Laminate Medical, Medtronic, and Philip; consulting fees and personal lecture fees from Abbott, Bayer, Becton-Dickinson, Boston Scientific, Inc, Cook, Cardiovascular Systems Inc., Inari Medical, Medtronic, Philips, Shockwave, and VentureMed; and participation on data safety monitoring boards for LIFE BTK, BIOMIMCS3D, HI-PEITHO, and Transcend. Dr Sharp reports consulting and lecture fees from Medtronic, Boston Scientific, Inc, Philips, Recor Medical, and Penumbra, Inc. Dr Sista reports research support from NIH/NHLBI as principal investigator of U34 and UG3 awards, unpaid participation on data safety monitoring boards for Angiodynamics, Inc, and Thrombolex, Inc; and participation on the Board of Directors for the Society of Interventional Radiology. Dr Wells reports participation on the data safety monitoring board for Anthos. The other authors report no conflicts.

Aims: Catheter-directed treatment (CDT) of acute pulmonary embolism (PE) is entering a growth phase in Europe following a steady increase in the USA in the past decade, but the potential economic impact on European healthcare systems remains unknown., Methods and Results: We built two statistical models for the monthly trend of proportion of CDT among patients with severe (intermediate- or high-risk) PE in the USA. The conservative model was based on admission data from the National Inpatient Sample (NIS) 2016-20 and the model reflecting increasing access to advanced treatment from the PERT™ national quality assurance database registry 2018-21. By applying these models to the forecast of annual PE-related hospitalizations in Germany, we calculated the annual number of severe PE cases and the expected increase in CDT use for the period 2025-30. The NIS-based model yielded a slow increase, reaching 3.1% (95% confidence interval 3.0-3.2%) among all hospitalizations with PE in 2030; in the PERT-based model, increase would be steeper, reaching 8.7% (8.3-9.2%). Based on current reimbursement rates, we estimated an increase of annual costs for PE-related hospitalizations in Germany ranging from 15.3 to 49.8 million euros by 2030. This calculation does not account for potential cost savings, including those from reduced length of hospital stay., Conclusion: Our approach and results, which may be adapted to other European healthcare systems, provide a benchmark for healthcare costs expected to result from CDT. Data from ongoing trials on clinical benefits and cost savings are needed to determine cost-effectiveness and inform reimbursement decisions., Competing Interests: Conflict of interest: K.M, Kl.K., Ka.K., H.B., T.N., C.A., I.T.F., T.M.T., K.C., M.L., J.R., and L.V.: no disclosures; B.K.: AngioDynamics, Penumbra, Viz.ai, and Dexcom (consultant); R.P.R.: BMS and Janssen (institutional research support); Abbott, Dova, Inari, Janssen, and Penumbra (advisory/consultant); STORM-PE National Lead Investigator, Penumbra; The PERT Consortium™ President; J.M.M.: AngioDynamics, Penumbra, Argon Medical, Pavmed, Auxetics, Innova Vascular, Inquis Medical, Retriever Medical, and Boston Scientific (consultant); K.R.: Abbott Vascular, AngioDynamics, Auxetics, Becton Dickinson, Boston Scientific, Contego, Imperative Care/TRUVIC, Johnson and Johnson Biosense Webster, Medtronic, Neptune Medical, Philips, SurModics, and Terumo (consultant/advisory board); Access Vascular, Aerami, Althea Medical, Auxetics, Contego, Endospan, Imperative Care/TRUVIC, Innova Vascular, InspireMD, JanaCare, Magneto, MedAlliance, Neptune Medical, Orchestra, ProSomnus, Sealonix, Shockwave, Skydance, Summa Therapeutics, Thrombolex, Valcare, Vantis Vascular, Vasorum, and VuMedi (equity or stock options); NIH, Abiomed, Boston Scientific, Novo Nordisk, Penumbra, and Gettinge-Atrium (research grants via institution); The National PERT Consortium™, Board of Directors; S.B. Boston Scientific, Medtronic, Bayer, and Sanofi (institutional research support by Board); Boston Scientific, Penumbra, and Viatris (personal fees/honoraria); R.N.C.: Penumbra, Steering Committee; J.S.G.: advisor and research fees to the institution from Boston Scientific and Inari Medical; equity in Endovascular Engineering; R.A.L.: Boston Scientific and Medtronic (advisory board); Penumbra, Abbott Vascular, Neptune Medical, Bard Vascular, Cordis, Biosense Webster, Becton Dickinson, SurModics, and Abbott Vascular (speakers bureau); Philips Healthcare, Spectranetics, Terumo, Boston Scientific, Inari, Penumbra, Ethicon, Vesper, and Black Swan (research support); Imperative Vascular, Summa Vascular, Innova Vascular, and Thrombolex (equity shareholder); L.H.: MSD and Janssen (personal lecture/consultant fees); S.V.K.: Bayer AG, Boston Scientific, Daiichi-Sankyo, LumiraDx, and Penumbra (personal lecture/advisory fees and research grants to institution); MSD, Pfizer, and Bristol-Myers Squibb (personal lecture/advisory fees); E.A.S.: NIH/NHLBI K23HL150290, Food & Drug Administration, and SCAI (funding); Abbott, BD, Boston Scientific, Cook, Medtronic, and Philips (grants to institution); Abbott, BD, Boston Scientific, Cagent, Conavi, Cook, Cordis, InfraRedx, Medtronic, Philips, Recor, Shockwave, and VentureMed (speaking/consulting)., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Balloon pulmonary angioplasty continues to gain traction as a treatment option for patients with chronic thromboembolic pulmonary disease with and without pulmonary hypertension. Recent European Society of Cardiology guidelines on pulmonary hypertension now give balloon pulmonary angioplasty a Class 1 recommendation for inoperable and residual chronic thromboembolic pulmonary hypertension. Not surprisingly, chronic thromboembolic pulmonary hypertension centers are rapidly initiating balloon pulmonary angioplasty programs. However, we need a comprehensive, expert consensus document outlining critical concepts, including identifying necessary personnel and expertise, criteria for patient selection, and a standardized approach to preprocedural planning and establishing criteria for evaluating procedural efficacy and safety. Given this lack of standards, the balloon pulmonary angioplasty skill set is learned through peer-to-peer contact and training. This document is a state-of-the-art, comprehensive statement from key thought leaders to address this gap in the current clinical practice of balloon pulmonary angioplasty. We summarize the current status of the procedure and provide a consensus opinion on the role of balloon pulmonary angioplasty in the overall care of patients with chronic thromboembolic pulmonary disease with and without pulmonary hypertension. We also identify knowledge gaps, provide guidance for new centers interested in initiating balloon pulmonary angioplasty programs, and highlight future directions and research needs for this emerging therapy.

Background: Contemporary care patterns/outcomes in high-risk pulmonary embolism (PE) patients are unknown., Objectives: This study sought to characterize the management of high-risk PE patients and identify factors associated with poor outcomes., Methods: A retrospective analysis of the PERT (Pulmonary Embolism Response Team) Consortium Registry was performed. Patients presenting with intermediate-risk PE, high-risk PE, and catastrophic PE (those with hemodynamic collapse) were identified. Patient characteristics were compared with chi-square testing for categorical covariates and Student's t-test for continuous covariates. Multivariable logistic regression was used to assess associations between clinical characteristics and outcomes in the high-risk population., Results: Of 5,790 registry patients, 2,976 presented with intermediate-risk PE and 1,442 with high-risk PE. High-risk PE patients were more frequently treated with advanced therapies than intermediate-risk PE patients (41.9% vs 30.2%; P < 0.001). In-hospital mortality (20.6% vs 3.7%; P < 0.001) and major bleeding (10.5% vs. 3.5%; P < 0.001) were more common in high-risk PE. Multivariable regression analysis demonstrated vasopressor use (OR: 4.56; 95% CI: 3.27-6.38; P < 0.01), extracorporeal membrane oxygenation use (OR: 2.86; 95% CI: 1.12-7.30; P = 0.03), identified clot-in-transit (OR: 2.26; 95% CI: 1.13-4.52; P = 0.02), and malignancy (OR: = 1.70; 95% CI: 1.13-2.56; P = 0.01) as factors associated with in-hospital mortality. Catastrophic PE patients (n = 197 [13.7% of high-risk PE patients]) had higher in-hospital mortality (42.1% vs 17.2%; P < 0.001) than those presenting with noncatastrophic high-risk PE. Extracorporeal membrane oxygenation (13.3% vs. 4.8% P < 0.001) and systemic thrombolysis (25% vs 11.3%; P < 0.001) were used more commonly in catastrophic PE., Conclusions: In the largest analysis of high-risk PE patients to date, mortality rates were high with the worst outcomes among patients with hemodynamic collapse., Competing Interests: Funding Support and Author Disclosures This work was funded through a grant from the PERT Consortium, a 501(c)3 not-for-profit organization. Dr Kobayashi’s institution has received funding for research from Inari medical and Endovascular Engineering. Dr Sethi has received honoraria/consulting fees from Boston Scientific, Janssen, Chiesi, Terumo, and Inari. Dr Parikh has received institutional research funding from Abbott, Boston Scientific, TriReme Medical, Shockwave Medical, Surmodics, Reflow Medical, Concept Medical, Veryan Medical, and MedAlliance; has served as an advisor to Abbott, Boston Scientific, Cordis, Medtronic, and Philips; and has served as a consultant for Terumo, Inari, Penumbra, and Canon. Dr Rosenfield has served as a consultant or on the scientific advisory board for Abbott Vascular, Althea Medical, Angiodynamics, Auxetics, Becton Dickinson, Boston Scientific, Contego, Crossliner, Imperative Care/Truvic, Innova Vascular, Inspire MD, Janssen/Johnson and Johnson, Magneto, Mayo Clinic, MedAlliance, Medtronic, Neptune Medical, Penumbra, Philips, Surmodics, Terumo, Thrombolex, Vasorum, Vantis Vascular, and Vumedi; owns equity or stock options in Access Vascular, Aerami, Althea Medical, Auxetics, Contego, Endospan, Imperative Care/Truvic, Innova Vascular, InspireMD, JanaCare, Magneto, MedAlliance, Neptune Medical, Orchestra, Prosomnus, Shockwave, Skydance, Summa Therapeutics, Thrombolex, Valcare, Vantis Vascular, Vasorum, and Vumedi; his institution has received funding from the National Institutes of Health, Abiomed, Boston Scientific, Novo Nordisk, Penumbra, Gettinge-Atrium; and has served on the Board of Directors of the National PERT Consortium. Dr Lookstein has served on the advisory board for Boston Scientific and Medtronic; has served as a consultant for Penumbra Vascular, Abbott Vascular, Neptune Medical, Imperative Vascular, Becton Dickinson Vascular, Biosense Webster, and Cordis Vascular; and owns equity in Imperative Vascular, Innova Vascular, Thrombolex, and Summa Vascular. Dr Gibson has served as a consultant for Alexion, AstraZeneca, Bayer, Janssen, and CytoSorbents. Dr Khandhar has received consulting fees from Inari Medical. Dr Secemsky has received consulting fees from Abbott, Bayer, BD, Boston Scientific, Cook, Cordis, CSI, HeartFlow, Inari, InfraRedx, Medtronic, Philips, RapidAI, Shockwave, and VentureMed; and his institution has received research funding from the National Institutes of Health/National Heart, Lung, and Blood Institute (K23HL150290), the U.S. Food and Drug Administration, the Society for Cardiovascular Angiography and Interventions, BD, Boston Scientific, Cook, CSI, Laminate Medical, Medtronic, and Philips. Dr Giri has served on the advisory board for and his institution has received research funding from Boston Scientific, Abbott Vascular, Recor Medical, Inari Medical, Edwards, and Abiomed; and owns equity in Endovascular Engineering. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Rationale: Acute pulmonary embolism is a leading cause of cardiovascular death. There are limited data on the national mortality trends from pulmonary embolism. Understanding these trends is crucial for addressing the mortality and associated disparities associated with pulmonary embolism. Objectives: To analyze the national mortality trends related to acute pulmonary embolism and determine the overall age-adjusted mortality rate (AAMR) per 100,000 population for the study period and assess changes in AAMR among different sexes, races, and geographic locations. Methods: We conducted a retrospective cohort analysis using mortality data of individuals aged ⩾15 years with pulmonary embolism listed as the underlying cause of death in the Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research database from January 2006 to December 2019. These data are produced by the National Center for Health Statistics. Results: A total of 109,992 pulmonary embolism-related deaths were noted in this dataset nationwide between 2006 and 2019. Of these, women constituted 60,113 (54.7%). The AAMR per 100,000 was not significantly changed, from 2.84 in 2006 to 2.81 in 2019 (average annual percentage change [AAPC], 0.2; 95% confidence interval [CI], -0.1 to 0.5; P  = 0.15). AAMR increased for men throughout the study period compared with women (AAPC, 0.7 for men; 95% CI, 0.3 to 1.2; P  = 0.004 vs. AAPC, -0.4 for women; 95% CI, -1.1 to 0.3; P  = 0.23, respectively). Similarly, AAMR for pulmonary embolism increased for Black compared with White individuals, from 5.18 to 5.26 (AAPC, 0.4; 95% CI, 0.0 to 0.7; P  = 0.05) and 2.82 to 2.86 (AAPC, 0.0; 95% CI, -0.6 to 0.6; P  = 0.99), respectively. Similarly, AAMR for pulmonary embolism was higher in rural areas than in micropolitan and large metropolitan areas during the study period (4.07 [95% CI, 4.02 to 4.12] vs. 3.24 [95% CI, 3.21 to 3.27] vs. 2.32 [95% CI, 2.30-2.34], respectively). Conclusions: Pulmonary embolism mortality remains high and unchanged over the past decade, and enduring sex, racial and socioeconomic disparities persist in pulmonary embolism. Targeted efforts to decrease pulmonary embolism mortality and address such disparities are needed.

Balloon pulmonary angioplasty (BPA) was first described in 2001 and now has evolved into a class I indication for inoperable or residual chronic thromboembolic pulmonary hypertension. This review article aims to describe evidence from studies performed at various pulmonary hypertension (PH) centers across the globe, to better understand the role of BPA in chronic thromboembolic pulmonary disease with and without PH. Additionally, we hope to highlight innovations and the ever-changing safety and efficacy profile of BPA., (Published by Elsevier Inc.)

Background: Balloon pulmonary angioplasty (BPA) was introduced as a treatment modality for patients with inoperable, medically refractory chronic thromboembolic pulmonary hypertension decades ago; however, reports of high rates of pulmonary vascular injury have led to considerable refinement in procedural technique., Objectives: The authors sought to better understand the evolution of BPA procedure-related complications over time., Methods: The authors conducted a systematic review of original articles published by pulmonary hypertension centers globally and performed a pooled cohort analysis of procedure-related outcomes with BPA., Results: This systematic review identified 26 published articles from 18 countries worldwide from 2013 to 2022. A total of 1,714 patients underwent 7,561 total BPA procedures with an average follow up of 7.3 months. From the first period (2013-2017) to the second period (2018-2022), the cumulative incidence of hemoptysis/vascular injury decreased from 14.1% (474/3,351) to 7.7% (233/3,029) (P < 0.01); lung injury/reperfusion edema decreased from 11.3% (377/3,351) to 1.4% (57/3,943) (P < 0.01); invasive mechanical ventilation decreased from 0.7% (23/3,195) to 0.1% (4/3,062) (P < 0.01); and mortality decreased from 2.0% (13/636) to 0.8% (8/1,071) (P < 0.01)., Conclusions: Procedure-related complications with BPA, including hemoptysis/vascular injury, lung injury/reperfusion edema, mechanical ventilation, and death, were less common in the second period (2018-2022), compared with first period (2013-2017), likely from refinement in patient and lesion selection and procedural technique over time., Competing Interests: Funding Support and Author Disclosures Dr Krasuski has been a consultant to Actelion/Janssen Pharmaceuticals, Bayer Pharmaceuticals, Gore Medical and Medtronic; and has received research funding from the Adult Congenital Heart Association, Actelion, Corvia, CryoLife, Edwards Lifesciences, and Medtronic. Dr Rosenfield has been a consultant to or served on scientific advisory boards for Abbott Vascular, Althea Medical, Angiodynamics, Auxetics, Becton-Dickinson, Boston Scientific, Contego, Crossliner, Innova Vascular, Inspire MD, Janssen/Johnson and Johnson, Magneto, Mayo Clinic, MedAlliance, Neptune Medical, Penumbra, Philips, Surmodics, Terumo, Thrombolex, Truvic, Vasorum, and Vumedi; has received institutional research grants from the NIH, Abiomed, Boston Scientific, Novo Nordisk, Penumbra, and Gettinge-Atrium; has equity interest in Accolade, Access Vascular, Aerami, Althea Medical, Auxetics, Contego, Crossliner, Cruzar Systems, Embolitech, Endospan, Imperative Care/Truvic, Innova Vascular, InspireMD, JanaCare, Magneto, MedAlliance, Neptune Medical, Orchestra, PQ Bypass, Prosomnus, Shockwave, Skydance, Summa Therapeutics, Thrombolex, Valcare, Vasorum, and Vumedi; and is a board member and founder of the National PERT Consortium. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Published by Elsevier Inc.)

Background: Catheter-directed thrombolysis (CDT) has been associated with rapid recovery of right ventricular (RV) function. The Bashir catheter was developed for enhanced thrombolysis in large vessels such as the pulmonary arteries (PAs) with lower doses of tissue plasminogen activator (tPA)., Objectives: The aim of this study was to evaluate the efficacy and safety of tPA infused using a pharmacomechanical (PM) CDT device called the Bashir endovascular catheter in patients with intermediate-risk acute pulmonary embolism (PE)., Methods: Patients with symptoms of acute PE with computed tomographic evidence of RV dilatation were enrolled. The Bashir catheter was used to deliver 7 mg tPA into each PA over 5 hours. The primary efficacy endpoint was the core laboratory-assessed change in computed tomographic angiography-derived RV/left ventricular (LV) diameter ratio at 48 hours, and the primary safety endpoint was serious adverse events (SAEs) including major bleeding at 72 hours., Results: At 18 U.S. sites, 109 patients were enrolled. The median device placement time was 15 minutes. At 48 hours after PM-CDT, the RV/LV diameter ratio decreased by 0.56 (33.3%; P < 0.0001). PA obstruction as measured by the refined modified Miller index was reduced by 35.9% (P < 0.0001). One patient (0.92%) had 2 SAEs: a retroperitoneal bleed (procedure related) and iliac vein thrombosis (device related). Two other procedure-related SAEs were epistaxis and non-access site hematoma with anemia., Conclusions: PM-CDT with the Bashir endovascular catheter is associated with a significant reduction in RV/LV diameter ratio and a very low rate of adverse events or major bleeding in patients with intermediate-risk acute PE. The notable finding was a significant reduction in PA obstruction with low-dose tPA. (Recombinant tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden [RESCUE]; NCT04248868)., Competing Interests: Funding Support and Author Disclosures The study was sponsored by the National Heart, Lung, and Blood Institute (NHLBI) under a Small Business Innovation Research grant to Thrombolex (Grant # R44HL151032-03, Principal investigator, Brian G. Firth, MD, PhD), the Commonwealth of Pennsylvania Department of Health, and Thrombolex. Dr Bashir is the coinventor of the Bashir endovascular catheter; has equity interest in Thrombolex; and is supported by an NHLBI grant under the Small Business Innovation Research grant mechanism. Dr Sista has received research grant support from the NHLBI; and is an unpaid member of the scientific advisory board of Thrombolex. Dr Piazza has received research grant support from EKOS, a BTG International Group company, Bayer, the Bristol Myers Squibb/Pfizer Alliance, Daiichi-Sankyo, Portola, and Janssen; and has received consulting fees from Amgen, Pfizer, Boston Scientific, and Thrombolex. Dr Firth is chief scientific officer for Thrombolex. Dr Comerota is a member of the scientific advisory board of Thrombolex. Dr Rosenfield is a member of the scientific advisory board or a consultant for Abbott Vascular, Access Vascular, Boston Scientific–BTG, Volcano-Philips, Surmodics, Cruzar Systems, Magneto, Summa Therapeutics, and the University of Maryland; is an unpaid member of the scientific advisory board of Thrombolex; has received grants from the National Institutes of Health and Boston Scientific; has equity in Access Vascular, Accolade, Contego, Endospan, Embolitech, Eximo, JanaCare, PQ Bypass, Primacea, MD Insider, Shockwave, Silk Road, Summa Therapeutics, Cruzar Systems, Capture Vascular, Magneto, Micell, and Valcare; and is a board member of VIVA Physicians, a not-for-profit 501(c)(3) organization, and the National PERT Consortium, a not-for-profit 501(c)(3) organization. Dr Darki has received research grant support from EKOS, a BTG International Group company. Dr Jaber has received consultation fees and institutional educational and research grants from Inari Medical and Medtronic. Dr Gandhi is a consultant to Boston Scientific, Medtronic, Penumbra, and Inari. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Due to the bleeding risk of full-dose systemic thrombolysis and the lack of major trials focusing on the clinical benefits of catheter-directed treatment, heparin antiocoagulation remains the standard of care for patients with intermediate-high-risk pulmonary embolism (PE)., Methods and Results: The Higher-Risk Pulmonary Embolism Thrombolysis (HI-PEITHO) study (ClinicalTrials.gov Identifier: NCT04790370) is a multinational multicenter randomized controlled parallel-group comparison trial. Patients with: (1) confirmed acute PE; (2) evidence of right ventricular (RV) dysfunction on imaging; (3) a positive cardiac troponin test; and (4) clinical criteria indicating an elevated risk of early death or imminent hemodynamic collapse, will be randomized 1:1 to treatment with a standardized protocol of ultrasound-facilitated catheter-directed thrombolysis plus anticoagulation, vs anticoagulation alone. The primary outcome is a composite of PE-related mortality, cardiorespiratory decompensation or collapse, or non-fatal symptomatic and objectively confirmed PE recurrence, within 7 days of randomization. Further assessments cover, apart from bleeding complications, a broad spectrum of functional and patient-reported outcomes including quality of life indicators, functional status and the utilization of health care resources over a 12-month follow-up period. The trial plans to include 406 patients, but the adaptive design permits a sample size increase depending on the results of the predefined interim analysis. As of May 11, 2022, 27 subjects have been enrolled. The trial is funded by Boston Scientific Corporation and through collaborative research agreements with University of Mainz and The PERT Consortium., Conclusions: Regardless of the outcome, HI-PEITHO will establish the first-line treatment in intermediate-high risk PE patients with imminent hemodynamic collapse. The trial is expected to inform international guidelines and set the standard for evaluation of catheter-directed reperfusion options in the future., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)

Acute pulmonary embolism (PE) is associated with significant morbidity and mortality. The management paradigm for acute PE has evolved in recent years with wider availability of advanced treatment modalities ranging from catheter-directed reperfusion therapies to mechanical circulatory support. This evolution has coincided with the development and implementation of institutional pulmonary embolism response teams (PERT) nationwide and internationally. Because most institutions are not equipped or staffed for advanced PE care, patients often require transfer to centers with more comprehensive resources, including PERT expertise. One of the unmet needs in current PE care is an organized approach to the process of interhospital transfer (IHT) of critically ill PE patients. In this review, we discuss medical optimization and support of patients before and during transfer, transfer checklists, defined roles of emergency medical services, and the roles and responsibilities of referring and receiving centers involved in the IHT of acute PE patients., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The Bashir Endovascular Catheter (BEC) is a novel pharmaco-mechanical device designed to enhance thrombolysis by increasing the exposure of thrombus to endogenous and exogenous thrombolytics. The aim of this prospective, multicenter, single-arm study was to evaluate the feasibility and initial safety of the BEC in patients with acute intermediate-risk pulmonary embolism (PE)., Methods: Patients with symptomatic PE and right ventricular to left ventricular diameter ratio ≥0.9 as documented by computer tomography angiography were eligible for enrollment. The primary safety end points were device related death or adverse events, and major bleeding within 72 hours after BEC directed therapy., Results: Nine patients were enrolled across 4 US sites. The total dose of r-tPA (recombinant tissue-type plasminogen activator) was 14 mgs in bilateral PE and 12 mgs in unilateral PE over 8 hours delivered via the expanded BEC. At 30-day follow-up, there were no deaths or device-related adverse events. At 48 hours post-BEC therapy, the right ventricular to left ventricular diameter ratio decreased from 1.52±0.26 to 0.97±0.06 ( P =0.0009 [95% CI, 0.33-0.82]; 37.0% reduction). Thrombus burden as measured by the Modified Miller Index decreased from 25.4±5.3 to 16.0±4.0 ( P =0.0005; [95% CI, 5.5-13.4]; 37.1% reduction)., Conclusions: In this early feasibility study of the BEC for intermediate-risk PE, there were no deaths or device-related adverse events and a significant reduction in right ventricular to left ventricular diameter ratio and thrombus burden. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03927508.

The coexistence of coronavirus disease 2019 (COVID-19) and pulmonary embolism (PE), two life-threatening illnesses, in the same patient presents a unique challenge. Guidelines have delineated how best to diagnose and manage patients with PE. However, the unique aspects of COVID-19 confound both the diagnosis and treatment of PE, and therefore require modification of established algorithms. Important considerations include adjustment of diagnostic modalities, incorporation of the prothrombotic contribution of COVID-19, management of two critical cardiorespiratory illnesses in the same patient, and protecting patients and health-care workers while providing optimal care. The benefits of a team-based approach for decision-making and coordination of care, such as that offered by pulmonary embolism response teams (PERTs), have become more evident in this crisis. The importance of careful follow-up care also is underscored for patients with these two diseases with long-term effects. This position paper from the PERT Consortium specifically addresses issues related to the diagnosis and management of PE in patients with COVID-19., (Copyright © 2020 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

Background: The FlowTriever Pulmonary Embolectomy Clinical Study (FLARE) was a multicenter, single-arm trial that demonstrated effectiveness of the FlowTriever percutaneous pulmonary embolectomy system in reducing right ventricular/left ventricular (RV/LV) diameter ratio in patients with acute intermediate-risk pulmonary embolism (PE). Patients diagnosed in emergency departments (EDs) with acute PE may have a different presentation from those diagnosed in an in-hospital setting., Objectives: The goal of this sub-study was to evaluate the safety and effectiveness of mechanical embolectomy in ED patients with acute intermediate-risk PE., Methods: ED patients with acute PE and RV/LV ratio ≥ 0.9 enrolled in the FLARE study were core laboratory analyzed. The primary efficacy endpoint was the change in RV/LV ratio from baseline to 48 h post procedure. The change in RV/LV ratio of patients with nonelevated cardiac troponin (cTn) and zero simplified PE Severity Index (sPESI) score (normal cTn-sPESI: intermediate-low risk) was also examined. Major adverse events (MAEs) included major bleeding, device-related death or clinical deterioration, and vascular or cardiac injury., Results: Seventy-six ED patients were included. Thirty-nine had a sPESI score of ≥ 1 and 32 had elevated cTn. The median preprocedure RV/LV ratio for all ED patients was 1.50 (0.88-2.52), with a change by -0.37 postprocedure (p < 0.001.) Three patients experienced MAEs. Seventeen patients (22.4%) presented with normal cTn-sPESI and had an RV/LV ratio reduced by 0.27 (p < 0.001) after embolectomy., Conclusion: ED patients with intermediate-risk PE had significant improvement in their RV/LV ratio and low complication rates when treated with mechanical embolectomy, irrespective of their baseline cTn-sPESI risk score., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the FlowTriever System (Inari Medical, Irvine, California) in a prospective trial of patients with acute intermediate-risk pulmonary embolism (PE)., Background: Catheter-directed thrombolysis has been shown to improve right ventricular (RV) function in patients with PE. However, catheter-directed thrombolysis increases bleeding risk and many patients with PE have relative and absolute contraindications to thrombolysis., Methods: Patients with symptomatic, computed tomography-documented PE and RV/left ventricular (LV) ratios ≥0.9 were eligible for enrollment. The primary effectiveness endpoint was core laboratory-assessed change in RV/LV ratio. The primary safety endpoint comprised device-related death, major bleeding, treatment-related clinical deterioration, pulmonary vascular injury, or cardiac injury within 48 h of thrombectomy., Results: From April 2016 to October 2017, 106 patients were treated with the FlowTriever System at 18 U.S. sites. Two patients (1.9%) received adjunctive thrombolytics and were analyzed separately. Mean procedural time was 94 min; mean intensive care unit stay was 1.5 days. Forty-three patients (41.3%) did not require any intensive care unit stay. At 48 h post-procedure, average RV/LV ratio reduction was 0.38 (25.1%; p < 0.0001). Four patients (3.8%) experienced 6 major adverse events, with 1 patient (1.0%) experiencing major bleeding. One patient (1.0%) died, of undiagnosed breast cancer, through 30-day follow-up., Conclusions: Percutaneous mechanical thrombectomy with the FlowTriever System appears safe and effective in patients with acute intermediate-risk PE, with significant improvement in RV/LV ratio and minimal major bleeding. Potential advantages include immediate thrombus removal, absence of thrombolytic complications, and reduced need for post-procedural critical care., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Pulmonary embolism (PE) is a life-threatening condition and a leading cause of morbidity and mortality. There have been many advances in the field of PE in the last few years, requiring a careful assessment of their impact on patient care. However, variations in recommendations by different clinical guidelines, as well as lack of robust clinical trials, make clinical decisions challenging. The Pulmonary Embolism Response Team Consortium is an international association created to advance the diagnosis, treatment, and outcomes of patients with PE. In this consensus practice document, we provide a comprehensive review of the diagnosis, treatment, and follow-up of acute PE, including both clinical data and consensus opinion to provide guidance for clinicians caring for these patients.

Intermediate-risk pulmonary embolism (PE) has variable outcomes. Current risk stratification models lack the positive predictive value to identify patients at highest risk of PE-related mortality. We identified intermediate-risk PE patients who underwent catheter-based interventions and right heart catheterization (RHC) and identified those with low cardiac index (CI < 2.2 L/min/m 2 ). We utilized regression models to identify echocardiographic predictors of low CI and Kaplan Meier curve to evaluate PE-related mortality when stratified by the echocardiographic predictor. Of 174 intermediate-risk PE patients, 41 underwent RHC. Within this cohort, 46.3% had low CI. Univariable linear regression identified right ventricular outflow tract velocity time integral (RVOT VTI), right/left ventricular ratio, S prime, inferior vena cava diameter, and pulmonary artery systolic pressure as potential predictors of low CI. Multivariable linear regression identified RVOT VTI as significant predictor of low CI (β coefficient 0.124, 95% confidence interval [CI]: 0.01-0.24, P = .034). Right ventricular outflow tract velocity time integral <9.5 cm was associated with increased PE-related mortality, P = .002. A substantial proportion of intermediate-risk PE patients referred for catheter-based interventions had low CI despite normotension. Right ventricular outflow tract velocity time integral was a significant predictor of low CI. Low RVOT VTI was associated with increased PE-related mortality.

Multidisciplinary pulmonary embolism response teams (PERTs) are being implemented to improve care of patients with life-threatening PE. We sought to determine how the creation of PERT affects treatment and outcomes of patients with serious PE. A pre- and post-intervention study was performed using an interrupted time series design, to compare patients with PE before (2006-2012) and after (2012-2016) implementation of PERT at a university hospital. T-tests, Chi square tests and logistic regression were used to compare outcomes, and multivariable regression were used to adjust for differences in PE severity. Two-sided p-value < 0.05 was considered significant. For the interrupted time-series analysis, data was divided into mutually exclusive 6-month time periods (11 pre- and 7 post-PERT). To examine changes in treatment and outcomes associated with PERT, slopes and change points were compared pre- and post-PERT. Two-hundred and twelve pre-PERT and 228 post-PERT patients were analyzed. Patient demographics were generally similar, though pre-PERT, PE were more likely to be low-risk (37% vs. 19%) while post-PERT, PE were more likely to be submassive (32% vs. 49%). More patients underwent catheter directed therapy (1% vs. 14%, p = < 0.0001) or any advanced therapy (19 [9%] vs. 44 [19%], p = 0.002) post PERT. Interrupted time series analysis demonstrated that this increase was sudden and coincident with implementation of PERT, and most noticeable among patients with submassive PE. There were no differences in major bleeding or mortality pre- and post-PERT. While the use of advanced therapies, particularly catheter-directed therapies, increased after creation of PERT, especially among patients with submassive PE, there was no apparent increase in bleeding.

Background: Extracorporeal membrane oxygenation (ECMO) has been used to stabilize patients with massive pulmonary embolism though few reports describe this approach. We describe the presentation, management and outcomes of patients who received ECMO for massive pulmonary embolism (PE) in our pulmonary embolism response team (PERT) registry., Methods: We enrolled a consecutive cohort of patients with confirmed PE for whom PERT was activated and selected patients treated with ECMO. We prospectively captured clinical, therapeutic and outcome data at the time of PERT activation and during the follow-up period for up to 365 days., Results: Thirteen patients who had PERT activation with confirmed PE diagnosis have undergone ECMO since the initiation of our PERT program in 2012. The mean age was 49 ± 19 years. Six (46%) patients were female. All the patients had cardiac arrest, either as an initial presentation or in-hospital cardiac arrest after presentation. All the patients exhibited right ventricular (RV) dilation on echocardiogram with RV hypokinesis. Eight (62%) patients received systemic thrombolysis with intravenous tissue plasminogen activator (tPA) and three (23%) patients underwent catheter-directed thrombolysis therapy using the EKOS system (EKOS Corporation, Bothell, WA, USA). Four (31%) patients underwent surgical embolectomy. Mean ECMO duration was 5.5 days, ranging from 2-18 days. Thirty-day mortality was 31% and one-year mortality was 54%., Conclusions: Patients with massive pulmonary embolism who suffer a cardiac arrest have high morbidity and mortality. ECMO can be used in conjunction with systemic thrombolysis, catheter-directed therapy or as a bridge to surgical embolectomy.

Background: Few contemporary studies have assessed the management and outcomes of patients with massive and submassive pulmonary embolism. Given advances in therapy, we report contemporary practice patterns and event rates among these patients., Methods: We analyzed a prospective database of patients with massive and submassive pulmonary embolism. We report clinical characteristics, therapies, and outcomes stratified by pulmonary embolism type. Treatment escalation beyond systemic anticoagulation was defined as advanced therapy. Cox proportional hazards regression was used to identify predictors of 90-day mortality., Results: Among 338 patients, 46 (13.6%) presented with massive and 292 (86.4%) with submassive pulmonary embolism. The average age was 63 ± 15 years, 49.9% were female, 32.0% had malignancy, and 21.9% had recent surgery. Massive pulmonary embolism patients received advanced therapy in 71.7% (30.4% systemic thrombolysis, 17.4% catheter-directed thrombolysis, 15.2% surgical embolectomy) and had greater 90-day mortality rates compared with submassive pulmonary embolism patients (41.3% vs 12.3%, respectively; P < .01). Most massive pulmonary embolism deaths (78.9%) occurred in-hospital, whereas mortality risk persisted after discharge for submassive pulmonary embolism. After multivariable adjustment, massive pulmonary embolism was associated with a 5.23-fold greater hazard of mortality (95% confidence interval, 2.70-10.13; P < .01). Advanced therapies among all pulmonary embolism patients were associated with a 61% reduction in mortality (95% confidence interval, 0.20-0.76; P < .01)., Conclusions: Among contemporary massive and submassive pulmonary embolism patients, mortality remains substantial. Advanced therapies were frequently utilized and independently associated with lower mortality. Further investigation is needed to determine how to improve outcomes among these high-risk patients, including the optimal use of advanced therapies., (Copyright © 2018. Published by Elsevier Inc.)

Pulmonary Embolism Response Teams (PERTs) are being created around the United States to immediately and simultaneously bring together multiple specialists to determine the best course of action and coordinate clinical care for patients with severe pulmonary embolism (PE). The organization and structure of each PERT will depend on local clinical demands and resources. Creating a follow up clinic for PE patients after discharge from the hospital is an essential component of any PERT program. PERT programs, which have come together to form the PERT Consortium®, are changing the landscape of PE treatment and may represent a new standard of care., (Copyright © 2018 Elsevier Inc. All rights reserved.)

There is a paucity of robust clinical trial data to guide the treatment of acute pulmonary embolism (PE) thus the clinical guidelines rely heavily on expert opinion. Pulmonary Embolism Response Teams (PERT) have been developed to streamline the care of patients with acute PE. We conducted a survey among 100 experts in the field of PE during the second annual meeting of the PERT Consortium. Respondents were queried with respect to their demographic information, clinical practice questions and clinical vignettes. Clinical practice questions were focused questions about the risk stratification and treatment of patients with acute submassive PE, anticoagulation strategies for patients receiving thrombolysis and the use of inferior vena cava filters. Clinical vignettes were designed to assess participants' preferred choice of treatment for a variety of commonly encountered clinical scenarios. Among physicians affiliated with a PERT, there is overall agreement with regards to the criteria used for risk classification of patients with PE and its application to patients in the provided clinical vignettes. In contrast, there is substantial variability in the treatment strategies of patients presenting with commonly encountered clinical scenarios. The results of this survey highlight the need for more clinical trial data along with accepted algorithms for treatment of acute PE. In the absence of this, PERTs can facilitate multidisciplinary discussions in order to standardize treatment and provide evidence-based therapies to patients with acute PE.

Background: Venous thromboembolism (VTE) is the third leading cause of vascular disease and accounts for $10 billion in annual US healthcare costs. The nationwide burden of 30-day readmissions after such events has not been comprehensively assessed., Methods and Results: We analyzed adults ≥18 years of age with hospitalizations associated with acute VTE between January 1, 2010, and December 31, 2014, in the Nationwide Readmissions Database. International Classification of Disease, Ninth Revision, Clinical Modification ( ICD-9- ) codes were used to identify hospitalizations associated with acute pulmonary embolism or deep vein thrombosis. The primary outcome was the rate of unplanned 30-day readmission. Hierarchical logistic regression was used to calculate hospital-specific 30-day risk-standardized readmission rates, a marker of healthcare quality. Among 1 176 335 hospitalizations with acute VTE, in-hospital death occurred in 6.2%. VTE was associated with malignancy in 19.7%, recent surgery in 19.3%, recent trauma in 4.6%, hypercoagulability in 3.3%, and pregnancy in 1.0%. Among survivors to discharge, the 30-day readmission rate was 17.5%, with no significant difference in rates across study years (17.4%-17.7%; CM ) codes were used to identify hospitalizations associated with acute pulmonary embolism or deep vein thrombosis. The primary outcome was the rate of unplanned 30-day readmission. Hierarchical logistic regression was used to calculate hospital-specific 30-day risk-standardized readmission rates, a marker of healthcare quality. Among 1 176 335 hospitalizations with acute VTE, in-hospital death occurred in 6.2%. VTE was associated with malignancy in 19.7%, recent surgery in 19.3%, recent trauma in 4.6%, hypercoagulability in 3.3%, and pregnancy in 1.0%. Among survivors to discharge, the 30-day readmission rate was 17.5%, with no significant difference in rates across study years (17.4%-17.7%; P =0.10 for trend). Major predictors of readmission were malignancy (relative risk, 1.49, 95% confidence interval 1.47-1.50), Medicaid insurance (relative risk, 1.48, 95% confidence interval 1.46-1.50), and nonelective index admission (relative risk, 1.31, 95% confidence interval 1.29-1.33). Top causes of readmission included sepsis (9.6%) and procedural complications (8.1%). Median rehospitalization costs were $9781.7 (interquartile range, $5430.7-$18 784.1), and 8.1% died during readmission. The interquartile range in risk-standardized readmission rates was 16.6% to 18.3%, suggesting modest interhospital heterogeneity in readmission risk., Conclusions: Nearly 1 in 5 patients with acute VTE were readmitted within 30 days. Predictors and causes of readmission were primarily related to patient characteristics and complications from comorbid conditions, whereas healthcare quality had a moderate impact on readmission risk., (© 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

Mortality associated with high-risk pulmonary embolism (PE) remains high. Extra-corporeal membrane oxygenation (ECMO) allows for acute hemodynamic stabilization and potentially for administration of other disease process altering therapies. We sought to compare two eras: pre-ECMO and post-ECMO in relation to high-risk PE treatment and mortality. A single-center retrospective chart review was conducted of high-risk PE patients. High-risk PE was defined as acute PE and cardiac arrest or shock. A total of 60 patients were identified, 31 in the pre-ECMO era and 29 in the post-ECMO era. Mean age was 56.1±21.1 years and 51.7% were women. More patients in the post-ECMO era were identified with computed tomography (82.8% vs 51.6%, p=0.011) and more patients in the post-ECMO era had right ventricular dysfunction on echocardiography (96.4% vs 78.3%, p=0.045). No other differences were noted in baseline characteristics or clinical, laboratory and imaging data between the two groups. In total, ECMO was used in 13 (44.8%) patients in the post-ECMO era. There was greater utilization of catheter-directed therapies in the post-ECMO era compared to the pre-ECMO era ( n = 7 (24.1%) vs n = 1 (3.2%), p=0.024). Thirty-day survival increased from 17.2% in patients who presented in the pre-ECMO era to 41.4% in the post-ECMO era ( p=0.043). While more work is necessary to better identify those PE patients who stand to benefit from mechanical circulatory support, our findings have important implications for the management of such patients.

Objectives: Pulmonary embolism response teams (PERT) are developing rapidly to operationalize multi-disciplinary care for acute pulmonary embolism patients. Our objective is to describe the core components of PERT necessary for newly developing programs., Methods: An online organizational survey of active National PERT™ Consortium members was performed between April and June 2016. Analysis, including descriptive statistics and Kruskal-Wallis tests, was performed on centers self-reporting a fully operational PERT program., Results: The survey response rate was 80%. Of the 31 institutions that responded (71% academic), 19 had fully functioning PERT programs. These programs were run by steering committees (17/19, 89%) more often than individual physicians (2/19, 11%). Most PERT programs involved 3-5 different specialties (14/19, 74%), which did not vary based on hospital size or academic affiliation. Of programs using multidisciplinary discussions, these occurred via phone or conference call (12/18, 67%), with a minority of these utilizing 'virtual meeting' software (2/12, 17%). Guidelines for appropriate activations were provided at 16/19 (84%) hospitals. Most PERT programs offered around-the-clock catheter-based or surgical care (17/19, 89%). Outpatient follow up usually occurred in personal physician clinics (15/19, 79%) or dedicated PERT clinics (9/19, 47%), which were only available at academic institutions., Conclusions: PERT programs can be implemented, with similar structures, at small and large, community and academic medical centers. While all PERT programs incorporate team-based multi-disciplinary care into their core structure, several different models exist with varying personnel and resource utilization. Understanding how different PERT programs impact clinical care remains to be investigated.

Objectives: The development of pulmonary embolism response teams (PERTs) has been widely adopted nationally with the goal of providing multidisciplinary care to patients with high-risk PE. Most PERT activations originate from the emergency department (ED), while others are from the intensive care unit (ICU) or inpatient floors. It is unclear if ED PERT activations differ from non-ED PERT activation in terms of presentation, management, and outcome., Methods: We enrolled a consecutive cohort of patients for whom PERT was activated at an urban academic medical center. We compared three groups of PERT activations based on whether the activation originated from the ED, ICU, or a non-ICU inpatient floor. We compared these groups in terms of the proportion of PERT activations that occurred during day, evening, or weekend hours and the proportion of confirmed PE. We also compared PE severity, treatment, and outcomes across locations. We tested differences using chi-square tests, with a two-tailed p-value of <0.05 considered statistically significant., Results: We enrolled 561 patients, of whom 449 (79.5%) had confirmed PE. The mean ± SD age of patients with confirmed PE was 61 ± 17 years, and 300 (53.5%) were male. Activations from the ED (n = 283, 88.4%) or floor (n = 100, 74.6%) were more likely to be for confirmed PE than activations from the ICU (n = 63, 58.9%; p < 0.0001). There was a statistical difference in the time of day of PERT activation with the ED having more activations during night hours than the ICU or floors (p = 0.004). Most activations for confirmed, massive PE originated from the ICU (n = 41, 65.1%), followed by the ED (n = 82, 29%) and inpatient floors (n = 22, 22%; p < 0.0001). Most activations from the ED (n = 155, 54.8%) and floors (n = 55, 55%) were for submassive PE. The use of thrombolysis or thrombectomy was more common among ICU patients (n = 18, 33.3%), followed by ED patients (n = 53, 19.6%) and then floor patients (n = 8, 8.2%). Mortality and major bleeding events were most common among ICU patients and similar among ED and floor patients., Conclusions: Pulmonary embolism response team activations from different clinical locations differ in terms of patient presentation, PE confirmation, treatments, and outcomes. PERTs should be customized to support the different needs of each clinical area., (© 2017 by the Society for Academic Emergency Medicine.)

Introduction: Acute pulmonary embolism (PE) is a common cardiovascular condition resulting in significant morbidity and mortality. Consensus recommendations suggest risk stratification of patients into three main categories: high-risk or 'massive' PE, intermediate-risk or 'submassive' PE, and low-risk PE. Given the relative dearth of prospective, randomized clinical trials delineating optimal selection of the diverse medical, interventional, and surgical treatment approaches, clinical care requires a multidisciplinary expert approach to patients with PE. Areas covered: The Massachusetts General Hospital (MGH) Pulmonary Embolism Response Team (PERT) was the first of its kind to create a multidisciplinary, rapid response team for acute PE, integrated within a research and educational framework. The MGH PERT has treated more than 700 patients with PE, the majority of which are in the 'massive' or 'submassive' categories. The PERT Consortium™ was founded in 2015 as a collaborative network between the growing number of PERT programs internationally, with greater than 80 institutions participating within one year of establishment. Expert commentary: Since its advent, the PERT model has expanded throughout the United States and internationally through a collaborative institutional and research network. PERT may represent a new standard for the care of patients with acute PE.

Pulmonary embolism (PE) is common and management is based on risk stratification. The significance of clot location in submassive and massive PE is unclear. Data from a prospectively gathered database of submassive and massive PE were used for analysis. Available data included patient presentation, diagnostics, treatment, and outcome. Comparisons were made according to clot location: central or peripheral. A multivariable model was used for composite outcome of death or right ventricular (RV) strain at 90 days. Among 269 patients, there were no significant demographic differences between patients with peripheral and central PE. Peripheral PE was more likely to present with hypotension (46.4% vs 32.6%; p = 0.02), but central PE was more likely to have RV strain on echocardiography (76.7% vs 57.7%, p <0.001) and computed tomography (58.1% vs 32.0%, p <0.0001). Peripheral PE was more likely to receive anticoagulation as the only form of therapy (69.1% vs 55.8%; p = 0.03), and central PE was more likely to receive catheter-directed therapies (18.3% vs 3.3%; p <0.001). Nonetheless, peripheral PE had higher 30- and 90-day all-cause mortality (18.5% vs 9.3%; p = 0.03; 25.9% vs 13.5%; p = 0.02, respectively). In a multivariable analysis, the only independent predictor of death or RV strain at 90 days was increased age (odds radio 1.35, CI 1.06 to 1.72 per 10 years). Specifically, neither clot location nor treatment was associated with patient outcomes. In conclusion, in this cohort of patients with submassive and massive PE, clot location was associated with treatment patterns but not patient outcomes to 90 days. Reevaluation of practice is thus warranted., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Pulmonary embolism (PE) is a serious and prevalent cause of vascular disease. Nevertheless, optimal treatment for many phenotypes of PE remains uncertain. Treating PE requires appropriate risk stratification as a first step. For the highest-risk PE, presenting as shock or arrest, emergent systemic thrombolysis or embolectomy is reasonable, while for low-risk PE, anticoagulation alone is often chosen. Normotensive patients with PE but with indicia of right heart dysfunction (by biomarkers or imaging) constitute an intermediate-risk group for whom there is controversy on therapeutic strategy. Some intermediate-risk patients with PE may require urgent stabilization, and ≈10% will decompensate hemodynamically and suffer high mortality, though identifying these specific patients remains challenging. Systemic thrombolysis is a consideration, but its risks of major and intracranial hemorrhages rival overall harms from intermediate PE. Multiple hybrid pharmacomechanical approaches have been devised to capture the benefits of thrombolysis while reducing its risks, but there is limited aggregate clinical experience with such novel interventional strategies. One method to counteract uncertainty and generate a consensus multidisciplinary prognostic and therapeutic plan is through a Pulmonary Embolism Response Team, which combines expertise from interventional cardiology, interventional radiology, cardiac surgery, cardiac imaging, and critical care. Such a team can help determine which intervention-catheter-directed fibrinolysis, ultrasound-assisted thrombolysis, percutaneous mechanical thrombus fragmentation, or percutaneous or surgical embolectomy-is best suited to a particular patient. This article reviews these various modalities and the background for each., (© 2017 American Heart Association, Inc.)

Background: Integrating newly developed tests and treatments for severe pulmonary embolism (PE) into clinical care requires coordinated multispecialty collaboration. To meet this need, we developed a new paradigm: a multidisciplinary Pulmonary Embolism Response Team (PERT). In this report, we provide the first longitudinal analysis of patients treated by a PERT., Methods: Our PERT includes specialists in cardiovascular medicine and surgery, emergency medicine, hematology, pulmonary/critical care, and radiology, and is organized as a rapid response team. We prospectively captured clinical, therapeutic, and outcome data at PERT activation and during follow-up periods up to 365 days. We analyzed data collectively, and as five mutually exclusive 6-month periods. We performed Fisher exact tests and regression analysis to test for trend., Results: In 30 months, there were 394 unique PERT activations, 314 (80%) for confirmed PE. PERT activations increased by 16% every 6 months. Most confirmed PEs were submassive (n = 143, 46%) or massive (n = 80, 26%). The PERT treated a relatively large proportion of patients with PE and systemic or catheter-directed thrombolysis (n = 35, 11%), though the most common treatment was anticoagulation alone (n = 215, 69%). Hemorrhagic complications were rare overall, especially among patients treated with catheter-directed thrombolysis. The all-cause 30-day mortality of PERT patients with confirmed PE was 12%., Conclusions: We report our initial 30-month experience with a novel multidisciplinary PERT that rapidly engages multiple specialists to deliver efficient, organized, and evidence-based care to patients with high-risk PE. The PERT paradigm was rapidly adopted and may become a new standard of care for patients with PE., (Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

Compared with recent advances in treatment of serious cardiovascular diseases, such as myocardial infarction and stroke, the treatment and outcome of acute pulmonary embolism (PE) have remained relatively unchanged over the last few decades. This has prompted several experts to call for the formation of multidisciplinary PE response teams with a more proactive approach to the treatment of PE. In the current document, we discuss the formation of such teams and describe the available treatment options beyond anticoagulation, with a focus on the interventional approach. Acknowledging the paucity of data to support widespread adoption of such techniques, we call for the collection of outcomes data in multicenter registries and support for randomized trials to evaluate interventional treatments in patients with high-risk PE., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: To describe the first single center experience with a novel aspiration thrombectomy device., Background: The appearance of inferior vena cava or right-sided intracardiac thrombus may prompt consideration of percutaneous thrombectomy as a method to prevent new or worsening pulmonary embolism (PE). The AngioVac is a novel thrombectomy device composed of a cannula and extracorporeal circuit with filter for pump-assisted removal of intravascular debris which is coupled with a reinfusion catheter for return of blood to the patient. The device has been approved by the United States Food and Drug Administration since 2009. This report represents the first significant case series describing its use, feasibility and outcomes in evacuating large caval thrombi or intracardiac masses in PE., Methods: This is a retrospective analysis of patient and case characteristics and in-hospital clinical outcomes of AngioVac thrombectomy in 14 consecutive patients treated between April 2010 and July 2013 at our institution., Results: Fourteen consecutive patients (mean age 50, 64% female) underwent 15 AngioVac procedures over 40 months. Indications included intracardiac mass (73%), acute PE (33%), and caval thrombus (73%). Four patients (27%) were in shock at the start of the procedure. Peri-procedure mortality was 0% and in-hospital mortality was 13% at a mean follow-up of 23 days. There were no pulmonary hemorrhages, strokes or myocardial infarctions. Though 73% had a post procedural drop in hematocrit, only two bleeding events were related to access site and required a transfusion., Conclusions: AngioVac thrombectomy is feasible in critically ill patients with acute DVT or PE and large caval thrombi or intracardiac masses., (© 2015 Wiley Periodicals, Inc.)

New and innovative tools have emerged for the treatment of massive and submassive pulmonary embolism (PE). These novel treatments, when considered alongside existing therapy, such as anticoagulation, systemic intravenous thrombolysis, and open surgical pulmonary embolectomy, have the potential to improve patient outcomes. However, data comparing different treatment modalities are sparse, and guidelines provide only general advice for their use. Treatment decisions rest on clinician expertise and institutional resources. Because various medical and surgical specialties offer different perspectives and expertise, a multidisciplinary approach to patients with massive and submassive PE is required. To address this need, we created a novel multidisciplinary program - the Massachusetts General Hospital (MGH) Pulmonary Embolism Response Team (PERT) - which brings together multiple specialists to rapidly evaluate intermediate- and high-risk patients with PE, formulate a treatment plan, and mobilize the necessary resources to provide the highest level of care. Development of a clinical, educational, and research infrastructure, as well as the creation of a national PERT consortium, will make our experience available to other institutions and serve as a platform for future studies to improve the care of complex patients with massive and submassive PE.