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Letter to the editor: Impact of right ventricular reserve during exercise on aortic valve opening in patients with a left ventricular assist device [Letter]

Kittipibul, Veraprapas; Katz, Jason N
PMID: 41511422
ISSN: 1557-3117
CID: 5981382

Withdrawal of aspirin in patients with left ventricular assist device treated with vitamin K antagonists: impact of anticoagulation quality in the randomized ARIES-HM3 trial

Connors, Jean M; Gustafsson, Finn; Uriel, Nir; Pagani, Francis D; Jorde, Ulrich P; Katz, Jason N; Netuka, Ivan; Zimpfer, Daniel; Nemeh, Hassan; Ransom, John M; Agarwal, Richa; Byku, Mirnela; Givertz, Michael M; Hall, Shelley; Kanwar, Manreet K; Cogswell, Rebecca; Sheikh, Farooq H; Phancao, Anita; Ravichandran, Ashwin; Conway, Jennifer; Adler, Eric; Chung, Eugene S; Grinstein, Jonathan; Dirckx, Nicholas; Chakouri, Nourdine; Mehra, Mandeep R
BACKGROUND AND AIMS/OBJECTIVE:Left ventricular assist devices (LVADs), including the HeartMate 3 (HM3), have improved outcomes in patients with advanced heart failure. Use of vitamin K antagonists (VKA) is mandated to reduce the risk of thrombotic events, but there is heterogeneity in management. Time in therapeutic range (TTR) is a crucial metric for assessing the quality of VKA management. The ARIES-HM3 trial demonstrated that aspirin can be safely omitted from the antithrombotic regimen, resulting in reduced bleeding without increased thrombosis. This pre-specified trial analysis explores the relationship of quality of VKA management assessed by TTR with haemocompatibility-related outcomes. METHODS:ARIES-HM3 was an international, randomized, double-blind, placebo-controlled study of aspirin (100 mg/day) or placebo (1:1) with VKA therapy in patients with de-novo HM3 placement. Participants were stratified into low TTR or high TTR groups based on median levels (n = 554). Primary endpoint success and secondary endpoint rates were stratified based on TTR groups. Bleeding rates at 12 months were estimated using an Andersen-Gill model with TTR as a single continuous variable, and multivariable regression analysis was performed. RESULTS:The percentage of patients with a TTR above or below the median of 56 was similar between the aspirin and placebo groups. More participants achieved primary endpoint success with TTR ≥56% (77% vs 66.9%, P = .01). Higher TTR was associated with lower bleeding rates at 12 months (26.4 vs 49.2 events per 100 participant-years; rate ratio 1.84, 95% confidence interval [CI] 1.37-2.53) without stroke increase (3.2 vs 2.8 events per 100 participant-years; rate ratio 0.88 [95% CI: 0.30-2.53]). No interaction was observed between the assigned treatment group and TTR. Modelling demonstrated a constant decrease in bleeding as a function of increasing TTR. Female sex and Black race were independent predictors of low TTR (odds ratio: 1.70 [95% CI: 1.12-2.57]; 1.62 [95% CI: 1.11-2.35], respectively), with more frequent INRs below the therapeutic range. Multivariable modelling identified age ≥65 years, aspirin use, TTR <56%, and blood urea nitrogen ≥30 mg/dL as predictors of non-surgical bleeding. CONCLUSIONS:The quality of VKA management as measured by TTR correlates with the occurrence of non-surgical bleeding in patients with the HM3 LVAD, with a lower TTR associated with an increased bleeding risk. These data provide new clinical direction to define a benchmark TTR to achieve further mitigation of residual risk of bleeding and enhance haemocompatibility with the HM3 LVAD.
PMID: 41206679
ISSN: 1522-9645
CID: 5966322

Characteristics and Outcomes of Patients With Cardiogenic Shock and Clinically Significant Valvular Heart Disease: From the Critical Care Cardiology Trials Network

Carnicelli, Anthony P; Miller, P Elliott; Berg, David D; Aliyev, Nijat; Alviar, Carlos L; Bohula, Erin A; Chaudhry, Sunit-Preet; Chonde, Meshe; Chow, Christine; Cooper, Howard A; Daniels, Lori B; Fordyce, Christopher B; Ghafghazi, Shahab; Goldfarb, Michael J; Gorder, Kari L; Hamilton, Madeleine M; Keane, Ryan R; Kontos, Michael C; Kusner, Jonathan J; Leibner, Evan; Loriaux, Daniel B; Menon, Venu; Nair, Raunak M; Newby, L Kristin; Oduah, Mary-Tiffany; Palazzolo, Michael G; Patolia, Harsh; Pierce, Jacob B; Pierce, Matthew J; Potter, Brian J; Proudfoot, Alastair; Roswel, Robert O; Schnell, Gregory; Shaw, Jeffrey; Sidhu, Kiran; Sinha, Shashank S; Varshney, Anubodh S; Katz, Jason N; Diepen, Sean VAN; Morrow, David A
BACKGROUND:Cardiogenic shock (CS) can be complicated by severe valvular heart disease (VHD). We analyzed cardiac intensive care unit (CICU) admissions according to VHD status. METHODS AND RESULTS/RESULTS:The Critical Care Cardiology Trials Network is a multicenter network of tertiary CICUs. Centers contributed data from consecutive admissions during 2-month annual snapshots from 2017-2023. CS admissions were classified as having CS attributed to VHD, CS with noncausative VHD or CS without severe VHD. Demographics and therapies were compared. Unadjusted and adjusted odds ratios for in-hospital mortality were calculated. We analyzed 5242 admissions with CS (4.1% attributed to VHD, 18.8% with noncausative VHD, 77.1% without severe VHD). Mitral regurgitation (32.1%) and aortic stenosis (27.9%) were the most common pathologies in CS attributed to VHD. Admissions with CS attributed to VHD more commonly had LVEF ≥ 40% on admission (present in 62.8%, 22.6% and 15.1%, respectively; P < 0.001). Valve intervention was performed in 32.1% of those with CS attributed to VHD. Unadjusted in-hospital mortality in admissions with CS attributed to VHD was 40.0%, compared to 33.4% and 30.3% in the other groups. CONCLUSIONS:VHD is the underlying cause of CS in a minority of CICU admissions but is associated with high in-hospital mortality rates.
PMID: 39970998
ISSN: 1532-8414
CID: 5843092

Respiratory Support and Mortality Risk Across the Spectrum of Cardiogenic Shock Severity

El Zarif, Talal; Caraballo, Cesar; Victoria-Castro, Angela M; Safiriyu, Israel; Gastanadui, Maria Gabriela; Dudzinski, David M; Senman, Balimkiz; Alviar, Carlos; Tavazzi, Guido; Elliott, Andrea; Rali, Aniket S; Jacobs, Mark; Katz, Jason N; Gage, Ann; Miller, P Elliott
BACKGROUND/UNASSIGNED:The Society for Cardiovascular Angiography & Intervention (SCAI) SHOCK stages classification schema risk-stratifies patients with cardiogenic shock (CS). The updated 2022 SCAI SHOCK stages removed the use of respiratory support, either noninvasive (NIV) or invasive mechanical ventilation (IMV), as a criterion. We sought to investigate the impact of receiving respiratory support on in-hospital mortality for patients with CS stratified by SCAI SHOCK stages. METHODS/UNASSIGNED:Utilizing a nationally representative database, adults aged ≥18 years admitted from 2015 to 2023 with a diagnosis of CS were used to assess for the association between respiratory support, either NIV or IMV, on the first day of admission, with in-hospital mortality stratified by SCAI SHOCK stages B through E. We utilized inverse probability treatment weighting, adjusting for demographic characteristics, comorbidities, hospital characteristics, and vasoactive/mechanical circulatory support. RESULTS/UNASSIGNED:We identified 317,325 patients with CS, including 2.4%, 39.0%, 34.2%, and 24.5% with SCAI stages B through E, respectively. Respiratory support was utilized in 38.0% (n = 120,594) of patients, with 5.4% receiving NIV, 33.8% receiving IMV, and 1.1% receiving both on the first day of admission. After inverse probability treatment weighting, respiratory support use remained associated with an increased mortality overall (weighted mean mortality increase of 18.3%; 95% CI, 17.9%-18.7%), when stratified by each SCAI SHOCK stage and in several key sensitivity analyses. CONCLUSIONS/UNASSIGNED:Compared with patients not receiving respiratory support, the use of respiratory support was associated with an increased mortality for each SCAI stage of CS and could be a simple, easily identifiable CS risk modifier.
PMCID:12766037
PMID: 41497992
ISSN: 2772-9303
CID: 5980902

Hemocompatibility Outcomes With Pharmacological Therapy Following LVAD Implantation: Insights From the ARIES-HM3 Trial

Katz, Jason N; Connors, Jean M; Pagani, Francis D; Jorde, Ulrich P; Gustafsson, Finn; Uriel, Nir; Netuka, Ivan; Byku, Mirnela; Anyanwu, Anelechi; Keebler, Mary; Nathan, Sriram; Selzman, Craig H; Alexis, Jeffrey D; Sulemanjee, Nasir; Atluri, Pavan; D'Allesandro, David; Porter, Sydney; Lee, Fei San; Mehra, Mandeep R; ,
BACKGROUND:The ARIES-HM3 (Antiplatelet Removal and Hemocompatibility Events With the HeartMate 3 Pump) trial demonstrated safety and decreased bleeding in eliminating aspirin from the antithrombotic regimen of patients implanted with a HM3 left ventricular assist device (LVAD). Whether pharmacologic therapies impact hemocompatibility-related adverse events (HRAEs) remains uncertain. OBJECTIVES/OBJECTIVE:In this trial analysis, the authors investigated associations between pharmacologic therapy and hemocompatibility outcomes. METHODS:Among 547 of 589 randomized patients who were discharged, non-inotrope-dependent, and completed 1-month of follow-up, the study explored the influence of pharmacotherapy (renin-angiotensin-aldosterone system [RAAS] inhibitors, heart failure [HF]-related and other cardiovascular drugs) on blood pressure control and on survival free of major nonsurgical HRAE (stroke, pump thrombosis, bleeding, and arterial thromboembolism) at 12 months. RESULTS:In 547 eligible patients, 65% received RAAS inhibitors, 89% received other HF-related therapy, and 82% received another cardiovascular drug at 1 month. No statistically significant interaction between RAAS inhibitors (P = 0.08), other HF-related therapies (P = 0.65), or other cardiovascular drugs (P = 0.92) on aspirin use and primary endpoint success was observed. Patients receiving RAAS inhibitors at 1 month had greater primary endpoint success (78.9% vs 69.3%, HR: 0.61 [95% CI: 0.37-1.01]; P = 0.14). Other HF-related therapies and cardiovascular drugs were not associated with primary event success either on or off prescription (HF-related therapy: 75.4% vs 76.7%; other cardiovascular drugs: 74.3% vs 81.3%). Pharmacologic therapy did not have a significant interaction with blood pressure control (RAAS inhibitors: P = 0.69; other HF-related therapy: P = 0.40). CONCLUSIONS:Background pharmacologic therapy did not modify the effect of aspirin on HRAE; however, the use of a RAAS inhibitor was independently associated with a reduction in HRAE. These exploratory observations may potentially point to opportunity for enhancing hemocompatibility in patients receiving LVAD therapy. (Antiplatelet Removal and Hemocompatibility Events With the HeartMate 3 Pump [ARIES-HM3]; NCT04069156).
PMID: 41258850
ISSN: 2213-1787
CID: 5975892

Towards an Understanding of Best Practice - The Good, The Bad and the Future of Cardiogenic Shock Teams

Senman, Balimkiz; Sinha, Shashank; Truesdell, Alexander G; Safiriyu, Israel; Drakos, Stavros; Dupont, Allison; Basir, Mir Babar; Miller, P Elliott; Rali, Aniket S; Bennett, Courtney; Tehrani, Behnam; Cowger, Jennifer; Hall, Shelley A; Rosner, Carolyn; Hackmann, Amy E; Wang, David E; Papolos, Alexander I; Kadosh, Bernard S; Vallabhajosyula, Saraschandra; Ferri, Michelle; Kochar, Ajar; Gage, Ann; Horowitz, James M; Katz, Jason N; ,
Cardiogenic shock (CS) remains a high-mortality condition that demands rapid diagnosis, coordinated multidisciplinary management, and timely initiation of mechanical circulatory support. As more institutions implement dedicated CS teams, substantial heterogeneity has emerged in how these teams are structured, activated, and sustained. To better characterize this variability and begin defining the components of an optimal CS team, the Society of Critical Care Cardiology (SoCCC), in partnership with the Society for Cardiovascular Angiography and Interventions (SCAI), convened the Inaugural Cardiogenic Shock Teams Think Tank. Held on October 17, 2024, as a pre-conference program to SCAI SHOCK 2024 in Washington, DC, the meeting brought together national leaders in CS care, mechanical circulatory support, and resuscitation to identify shared challenges and propose practical solutions. This manuscript summarizes key insights from this inaugural Think Tank, which represents the first in an ongoing series of collaborative efforts aimed at informing the standardization and optimization of CS teams nationwide. Specifically, we review the ideal composition and core competencies of a CS team; the rationale and emerging evidence supporting dedicated team-based CS care; activation algorithms and operational workflows; and common barriers to establishing and sustaining such teams. We also outline future directions and opportunities to strengthen collaborative infrastructure, refine clinical pathways, and enhance the reliability, responsiveness, and effectiveness of cardiogenic shock teams across diverse healthcare settings.
PMID: 41285212
ISSN: 1097-6744
CID: 5968062

Impact of Atrial Fibrillation, Diabetes Mellitus and Obesity on Outcomes with Aspirin Avoidance and Hemocompatibility with a Left Ventricular Assist Device: An analysis from the ARIES-HM3 Trial

Uriel, Nir; Netuka, Ivan; Jorde, Ulrich P; Pagani, Francis D; Katz, Jason N; Connors, Jean M; Ivak, Peter; Zimpfer, Daniel; Pya, Yuriy; Conway, Jennifer; Gustafsson, Finn; Nathan, Sriram; Scandroglio, Anna Mara; Hayward, Christopher; D'Alessandro, David A; Collins, Morgan; Dirckx, Nicholas; Mehra, Mandeep R
BACKGROUND:The ARIES-HM3 trial demonstrated the safety and effectiveness of aspirin elimination from the antithrombotic regimen after HeartMate 3 (HM3) LVAD implantation. We explored the interaction of atrial fibrillation, diabetes mellitus and obesity [AF/DM/Ob] with aspirin elimination on hemocompatibility-related adverse events (HRAE) at 1 year post-implant. METHODS:level suppression. RESULTS:levels. CONCLUSION/CONCLUSIONS:Among ARIES-HM3 trial patients with AF/DM/Ob, either comorbidity alone or in combination, did not alter the safety or observed effect size on bleeding reduction with aspirin elimination in patients implanted with the HM3 LVAD.
PMID: 41308860
ISSN: 1532-8414
CID: 5968652

Modern Cardiac ICU Care Delivery and the Role of the Cardiac ICU Cardiologist: Submitted on behalf of the American College of Cardiology's Critical Care Cardiology Council and the Society of Critical Care Cardiology

Papolos, Alexander I; Brusca, Samuel B; Barnett, Christopher F; Kenigsberg, Benjamin B; Roswell, Robert O; Solomon, Michael A; Gutierez, Alejandra; Lee, Ran; Tachil, Rosy; Katz, Jason N; Yuriditsky, Eugene; Chaudhry, Sunit-Preet; Duvvuri, Padmaraj; Geller, Bram J; Jentzer, Jacob C
BACKGROUND:The cardiac intensive care unit (CICU) has evolved into a complex care environment for critically ill patients with cardiac and noncardiac diseases. OBJECTIVES/OBJECTIVE:Our goal was to describe contemporary CICU care delivery and the role of cardiologists therein. METHODS:The American College of Cardiology administered a 42-item survey to U.S. and Canadian CICU-focused cardiologists designed to capture models of care delivery and workforce demographics. RESULTS:The survey was distributed by email to 1,085 U.S. and Canadian CICU cardiologists. The response rate was 20%, yielding a final sample of 166 after excluding trainees and those not board-certified or board-eligible in cardiology. The majority were from medium (34%) or large (64%) academic (81%) medical centers. Fifty-three percent reported working in high-intensity care models and 61% reported that their CICU was dedicated exclusively to medical cardiology patients. Critical care medicine-boarded physicians contributed to care through consultative (53%), comanagement (29%), and/or primary roles (44%). Subspecialization beyond cardiology was common (82%), with critical care medicine being most frequent (46%), followed by echocardiography (37%), advanced heart failure (21%), and interventional cardiology (16%). Limitations include the low survey response rate, which raises the risk of selection bias. CONCLUSIONS:This study provides insight into the current landscape of cardiac critical care delivery in North America, highlighting wide variation in staffing models, subspecialty training, and clinical practice. Our findings highlight growing trends toward high-intensity staffing models that incorporate critical care medicine-boarded physicians in consultative, comanagement, and or primary roles.
PMID: 41297175
ISSN: 2772-963x
CID: 5968402

Efficacy and Safety of Different Combinations of Add-on Diuretic Therapy in Acute Heart Failure: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials

Sephien, Andrew; Girgis, Julia G; Reljic, Tea; Dayto, Denisse Camille; Joly, Joanna M; Katz, Jason N; Tallaj, Jose A; Colombo, Rosario A; Tsalatsanis, Athanasios; Kumar, Ambuj
Patients hospitalized with acute heart failure (HF) may experience diuretic resistance and require an add-on agent despite increasing loop diuretic dosage. While randomized controlled trials (RCTs) have compared add-on therapy to loop diuretics only, sparse literature exists on direct comparisons between various add-on therapies. We performed a systematic review and network meta-analysis of RCTs to assess the efficacy and safety of different diuretic add-on therapies in patients hospitalized with acute HF. Any RCT evaluating the effect of add-on diuretic therapy in patients hospitalized with acute HF was eligible for inclusion. A complete search of EMBASE and PubMed was conducted until March 29, 2024. The primary outcome was the hospital length of stay. Data was pooled using a random-effects model for direct comparisons. A network meta-analysis using frequentist methods was performed under random-effects multiple treatment comparisons. We assessed ranking probability by surface under the cumulative ranking curve (SUCRA). Of the 1,103 references, 29 RCTs enrolling 8,362 patients met the eligibility and were included. For the direct comparisons, there was no significant difference in hospital length of stay (MD -0.42, 95% CI= -0.87,0.02). Ranking probability based on SUCRA indicated that acetazolamide had the highest likelihood of being the best treatment for shorter hospital length of stay (SUCRA, 0.89), followed by SGLT2i (SUCRA, 0.70). The certainty of estimates for all outcomes ranged from moderate to very low. In conclusion, the efficacy of add-on therapy was associated with reduced hospital length of stay. Albeit uncertain, the results from NMA provide initial evidence suggesting there may be optimal treatment strategies to decongest patients with heart failure to achieve and maintain euvolemia. However, well-designed direct comparison RCTs are needed to increase the certainty of the estimates. Protocol registered in PROSPERO (CRD42023476669).
PMID: 40876527
ISSN: 1879-1913
CID: 5910592

An Educational Curriculum for Residents, Advanced Practice Providers, and Fellows in Cardiac Intensive Care Units

Carnicelli, Anthony P; Senman, Balimkiz C; Miller, P Elliott; Dahiya, Garima; Jentzer, Jacob C; Ambalavanan, Manoj S; Garfinkel, Amanda C; Zaas, Aimee; Poindexter, Elizabeth; Judge, Dan P; Sinha, Shashank S; Berg, David D; Elliott, Andrea M; Morrow, David A; Katz, Jason N
The contemporary cardiac intensive care unit (CICU) serves as a dynamic educational environment for postgraduate physicians and advanced practice provider trainees. This educational experience, however, can vary substantially between institutions. Specific learning objectives are needed to standardize the educational experience for trainees rotating through the contemporary CICU. We provide a structured, CICU-based curriculum emphasizing exposure to a wide spectrum of cardiovascular pathologies and incorporating learner progression from early to advanced stages, adaptable to a variety of training pathways. Prioritizing standardized educational objectives during training will better prepare learners for further subspecialty training programs and the complexities of modern CICU-based practice.
PMID: 40882606
ISSN: 2772-963x
CID: 5910812