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Surgical Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation: Interim analysis of the TVVAD trial

Mendiola Pla, Michelle; Chiang, Yuting; Nicoara, Alina; Poehlein, Emily; Green, Cynthia L; Gross, Ryan; Bryner, Benjamin S; Schroder, Jacob N; Daneshmand, Mani A; Russell, Stuart D; DeVore, Adam D; Patel, Chetan B; Katz, Jason N; Milano, Carmelo A; Bishawi, Muath
OBJECTIVES/OBJECTIVE:Right heart failure remains a serious complication of left ventricular assist device therapy. Many patients presenting for left ventricular assist device implantation have significant tricuspid regurgitation. It remains unknown whether concurrent tricuspid valve surgery reduces postoperative right heart failure. The primary aim was to identify whether concurrent tricuspid valve surgery reduced the incidence of moderate or severe right heart failure within the first 6 months after left ventricular assist device implantation. METHODS:Patients with moderate or severe tricuspid regurgitation on preoperative echocardiography were randomized to left ventricular assist device implantation alone (no tricuspid valve surgery) or with concurrent tricuspid valve surgery. Randomization was stratified by preoperative right ventricular dysfunction. The primary end point was the frequency of moderate or severe right heart failure within 6 months after surgery. RESULTS:This report describes a planned interim analysis of the first 60 randomized patients. The tricuspid valve surgery group (n = 32) had mild or no tricuspid regurgitation more frequently on follow-up echocardiography studies compared with the no tricuspid valve surgery group (n = 28). However, at 6 months, the incidence of moderate and severe right heart failure was similar in each group (tricuspid valve surgery: 46.9% vs no tricuspid valve surgery: 50%, P = .81). There was no significant difference in postoperative mortality or requirement for right ventricular assist device between the groups. There were also no significant differences in secondary end points of functional status and adverse events. CONCLUSIONS:The presence of significant tricuspid regurgitation before left ventricular assist device is associated with a high incidence of right heart failure within the first 6 months after surgery. Tricuspid valve surgery was successful in reducing postimplant tricuspid regurgitation compared with no tricuspid valve surgery but was not associated with a lower incidence of right heart failure.
PMCID:10185708
PMID: 36639288
ISSN: 1097-685x
CID: 5783182

Modes of Death in Patients with Cardiogenic Shock in the Cardiac Intensive Care Unit: A Report from the Critical Care Cardiology Trials Network

Berg, David D; Singal, Sachit; Palazzolo, Michael; Baird-Zars, Vivian M; Bofarrag, Fadel; Bohula, Erin A; Chaudhry, Sunit-Preet; Dodson, Mark W; Hillerson, Dustin; Lawler, Patrick R; Liu, Shuangbo; O'Brien, Connor G; Pisani, Barbara A; Racharla, Lekha; Roswell, Robert O; Shah, Kevin S; Solomon, Michael A; Sridharan, Lakshmi; Thompson, Andrea D; Diepen, Sean VAN; Katz, Jason N; Morrow, David A; ,
BACKGROUND:There are limited data on how patients with cardiogenic shock (CS) die. METHODS:The Critical Care Cardiology Trials Network is a research network of cardiac intensive care units coordinated by the Thrombolysis In Myocardial Infarction (TIMI) Study Group (Boston, MA). Using standardized definitions, site investigators classified direct modes of in-hospital death for CS admissions (October 2021 to September 2022). Mutually exclusive categories included 4 modes of cardiovascular death and 4 modes of noncardiovascular death. Subgroups defined by CS type, preceding cardiac arrest (CA), use of temporary mechanical circulatory support (tMCS), and transition to comfort measures were evaluated. RESULTS:Among 1068 CS cases, 337 (31.6%) died during the index hospitalization. Overall, the mode of death was cardiovascular in 82.2%. Persistent CS was the dominant specific mode of death (66.5%), followed by arrhythmia (12.8%), anoxic brain injury (6.2%), and respiratory failure (4.5%). Patients with preceding CA were more likely to die from anoxic brain injury (17.1% vs 0.9%; P < .001) or arrhythmia (21.6% vs 8.4%; P < .001). Patients managed with tMCS were more likely to die from persistent shock (P < .01), both cardiogenic (73.5% vs 62.0%) and noncardiogenic (6.1% vs 2.9%). CONCLUSIONS:Most deaths in CS are related to direct cardiovascular causes, particularly persistent CS. However, there is important heterogeneity across subgroups defined by preceding CA and the use of tMCS.
PMCID:11098678
PMID: 38387758
ISSN: 1532-8414
CID: 5655512

Early Serial Assessment of Aggregate Vasoactive Support and Mortality in Cardiogenic Shock: Insights From the Critical Care Cardiology Trials Network Registry

Patel, Siddharth M; Berg, David D; Bohula, Erin A; Baird-Zars, Vivian M; Barsness, Gregory W; Chaudhry, Sunit-Preet; Chonde, Meshe D; Cooper, Howard A; Ginder, Curtis; Jentzer, Jacob C; Kontos, Michael C; Miller, P Elliott; Newby, L Kristin; O'Brien, Connor G; Park, Jeong-Gun; Pierce, Matthew J; Pisani, Barbara A; Potter, Brian J; Shah, Kevin S; Teuteberg, Jeffrey J; Katz, Jason N; van Diepen, Sean; Morrow, David A
BACKGROUND/UNASSIGNED:Associations of early changes in vasoactive support with cardiogenic shock (CS) mortality remain incompletely defined. METHODS/UNASSIGNED:The Critical Care Cardiology Trials Network is a multicenter registry of cardiac intensive care units. Patients admitted with CS (2018-2023) had vasoactive dosing assessed at 4 and 24 hours from cardiac intensive care unit admission and quantified by the vasoactive-inotropic score (VIS). Prognostic associations of VIS at both time points, as well as change in VIS from 4 to 24 hours, were examined. Interaction testing was performed based on mechanical circulatory support status. RESULTS/UNASSIGNED: CONCLUSIONS/UNASSIGNED:Early changes in the magnitude of vasoactive support in CS are associated with a gradient of risk for mortality. These data suggest that early VIS trajectory may improve CS prognostication, with the potential to be leveraged for clinical decision-making and research applications in CS.
PMID: 38587438
ISSN: 1941-3297
CID: 5653942

Variation in risk-adjusted cardiac intensive care unit (CICU) length of stay and the association with in-hospital mortality: An analysis from the Critical Care Cardiology Trials Network (CCCTN) registry

Koerber, Daniel M; Katz, Jason N; Bohula, Erin; Park, Jeong-Gun; Dodson, Mark W; Gerber, Daniel A; Hillerson, Dustin; Liu, Shuangbo; Pierce, Matthew J; Prasad, Rajnish; Rose, Scott W; Sanchez, Pablo A; Shaw, Jeffrey; Wang, Jeffrey; Jentzer, Jacob C; Kristin Newby, L; Daniels, Lori B; Morrow, David A; van Diepen, Sean
BACKGROUND:Previous studies have suggested that there is wide variability in cardiac intensive care unit (CICU) length of stay (LOS); however, these studies are limited by the absence of detailed risk assessment at the time of admission. Thus, we evaluated inter-hospital differences in CICU LOS, and the association between LOS and in-hospital mortality. METHODS:Using data from the Critical Care Cardiology Trials Network (CCCTN) registry, we included 22,862 admissions between 2017 and 2022 from 35 primarily tertiary and quaternary CICUs that captured consecutive admissions in annual 2-month snapshots. The primary analysis compared inter-hospital differences in CICU LOS, as well as the association between CICU LOS and all-cause in-hospital mortality using a Fine and Gray competing risk model. RESULTS:= 0.31) with a higher risk of 30-day in-hospital mortality. The relationship remained significant in admissions with heart failure, ST-elevation myocardial infarction and non-ST segment elevation myocardial infarction. CONCLUSIONS:In a large registry of academic CICUs, we observed significant variation in CICU LOS and report that LOS is independently associated with all-cause in-hospital mortality. These findings could potentially be used to improve CICU resource utilization planning and refine risk prognostication in critically ill cardiovascular patients.
PMID: 38369218
ISSN: 1097-6744
CID: 5788452

Cardiogenic Shock in Older Adults: A Focus on Age-Associated Risks and Approach to Management: A Scientific Statement From the American Heart Association

Blumer, Vanessa; Kanwar, Manreet K; Barnett, Christopher F; Cowger, Jennifer A; Damluji, Abdulla A; Farr, Maryjane; Goodlin, Sarah J; Katz, Jason N; McIlvennan, Colleen K; Sinha, Shashank S; Wang, Tracy Y; ,
Cardiogenic shock continues to portend poor outcomes, conferring short-term mortality rates of 30% to 50% despite recent scientific advances. Age is a nonmodifiable risk factor for mortality in patients with cardiogenic shock and is often considered in the decision-making process for eligibility for various therapies. Older adults have been largely excluded from analyses of therapeutic options in patients with cardiogenic shock. As a result, despite the association of advanced age with worse outcomes, focused strategies in the assessment and management of cardiogenic shock in this high-risk and growing population are lacking. Individual programs oftentimes develop upper age limits for various interventional strategies for their patients, including heart transplantation and durable left ventricular assist devices. However, age as a lone parameter should not be used to guide individual patient management decisions in cardiogenic shock. In the assessment of risk in older adults with cardiogenic shock, a comprehensive, interdisciplinary approach is central to developing best practices. In this American Heart Association scientific statement, we aim to summarize our contemporary understanding of the epidemiology, risk assessment, and in-hospital approach to management of cardiogenic shock, with a unique focus on older adults.
PMCID:11067718
PMID: 38406869
ISSN: 1524-4539
CID: 5788462

Prognostic performance of the IABP-SHOCK II Risk Score among cardiogenic shock subtypes in the critical care cardiology trials network registry

Alviar, Carlos L; Li, Boyangzi K; Keller, Norma M; Bohula-May, Erin; Barnett, Christopher; Berg, David D; Burke, James A; Chaudhry, Sunit-Preet; Daniels, Lori B; DeFilippis, Andrew P; Gerber, Daniel; Horowitz, James; Jentzer, Jacob C; Katrapati, Praneeth; Keeley, Ellen; Lawler, Patrick R; Park, Jeong-Gun; Sinha, Shashank S; Snell, Jeffrey; Solomon, Michael A; Teuteberg, Jeffrey; Katz, Jason N; van Diepen, Sean; Morrow, David A; ,
BACKGROUND:Risk stratification has potential to guide triage and decision-making in cardiogenic shock (CS). We assessed the prognostic performance of the IABP-SHOCK II score, derived in Europe for acute myocardial infarct-related CS (AMI-CS), in a contemporary North American cohort, including different CS phenotypes. METHODS:The critical care cardiology trials network (CCCTN) coordinated by the TIMI study group is a multicenter network of cardiac intensive care units (CICU). Participating centers annually contribute ≥2 months of consecutive medical CICU admissions. The IABP-SHOCK II risk score includes age > 73 years, prior stroke, admission glucose > 191 mg/dl, creatinine > 1.5 mg/dl, lactate > 5 mmol/l, and post-PCI TIMI flow grade < 3. We assessed the risk score across various CS etiologies. RESULTS:= 0.17) and the IABP-SHOCK II score revealed a significant risk gradient within each SCAI stage. CONCLUSIONS:In an unselected international multicenter registry of patients admitted with CS, the IABP- SHOCK II score only moderately predicted in-hospital mortality in a broad population of CS regardless of etiology or irrespective of right, left, or bi-ventricular involvement.
PMID: 38190931
ISSN: 1097-6744
CID: 5639692

Need for a Cardiogenic Shock Team Collaborative-Promoting a Team-Based Model of Care to Improve Outcomes and Identify Best Practices

Senman, Balimkiz; Jentzer, Jacob C; Barnett, Christopher F; Bartos, Jason A; Berg, David D; Chih, Sharon; Drakos, Stavros G; Dudzinski, David M; Elliott, Andrea; Gage, Ann; Horowitz, James M; Miller, P Elliott; Sinha, Shashank S; Tehrani, Behnam N; Yuriditsky, Eugene; Vallabhajosyula, Saraschandra; Katz, Jason N
Cardiogenic shock continues to carry a high mortality rate despite contemporary care, with no breakthrough therapies shown to improve survival over the past few decades. It is a time-sensitive condition that commonly results in cardiovascular complications and multisystem organ failure, necessitating multidisciplinary expertise. Managing patients with cardiogenic shock remains challenging even in well-resourced settings, and an important subgroup of patients may require cardiac replacement therapy. As a result, the idea of leveraging the collective cognitive and procedural proficiencies of multiple providers in a collaborative, team-based approach to care (the "shock team") has been advocated by professional societies and implemented at select high-volume clinical centers. A slowly maturing evidence base has suggested that cardiogenic shock teams may improve patient outcomes. Although several registries exist that are beginning to inform care, particularly around therapeutic strategies of pharmacologic and mechanical circulatory support, none of these are currently focused on the shock team approach, multispecialty partnership, education, or process improvement. We propose the creation of a Cardiogenic Shock Team Collaborative-akin to the successful Pulmonary Embolism Response Team Consortium-with a goal to promote sharing of care protocols, education of stakeholders, and discovery of how process and performance may influence patient outcomes, quality, resource consumption, and costs of care.
PMID: 38456417
ISSN: 2047-9980
CID: 5639802

Training Paradigms in Critical Care Cardiology: A Scoping Review of Current Literature

Vallabhajosyula, Saraschandra; Mehta, Aryan; Bansal, Mridul; Jentzer, Jacob C; Applefeld, Willard N; Sinha, Shashank S; Geller, Bram J; Gage, Ann E; Rose, Scott W; Barnett, Christopher F; Katz, Jason N; Morrow, David A; Roswell, Robert O; Solomon, Michael A
BACKGROUND/UNASSIGNED:Over the past decade there has been increasing interest in critical care medicine (CCM) training for cardiovascular medicine (CV) physicians either in isolation (separate programs in either order [CV/CCM], integrated critical care cardiology [CCC] training) or hybrid training with interventional cardiology (IC)/heart failure/transplant (HF) with targeted CCC training. OBJECTIVE/UNASSIGNED:To review the contemporary landscape of CV/CCM, CCC, and hybrid training. METHODS/UNASSIGNED:We reviewed the literature from 2000-2022 for publications discussing training in any combination of internal medicine CV/CCM, CCC, and hybrid training. Information regarding training paradigms, scope of practice and training, duration, sequence, and milestones was collected. RESULTS/UNASSIGNED:Of the 2,236 unique citations, 20 articles were included. A majority were opinion/editorial articles whereas two were surveys. The training pathways were classified into - (i) specialty training in both CV (3 years) and CCM (1-2 years) leading to dual American Board of Internal Medicine (ABIM) board certification, or (ii) base specialty training in CV with competencies in IC, HF or CCC leading to a non-ABIM certificate. Total fellowship duration varied between 4-7 years after a three-year internal medicine residency. While multiple articles commented on the ability to integrate the fellowship training pathways into a holistic and seamless training curriculum, few have highlighted how this may be achieved to meet competencies and standards. CONCLUSIONS/UNASSIGNED:In 20 articles describing CV/CCM, CCC, and hybrid training, there remains significant heterogeneity on the standardized training paradigms to meet training competencies and board certifications, highlighting an unmet need to define CCC competencies.
PMID: 38352139
ISSN: 2772-963x
CID: 5737562

Efficacy of Intravenous Iron in Patients with Heart Failure with Reduced Ejection Fraction and Iron Deficiency: A Systematic Review and Meta-Analysis of Randomized Control Trials

Sephien, Andrew; Dayto, Denisse Camille; Reljic, Tea; Prida, Xavier; Joly, Joanna M; Tavares, Matthew; Katz, Jason N; Kumar, Ambuj
BACKGROUND:The European Society of Cardiology (ESC) provided a focused update to the 2021 Guideline for the Management of Heart Failure, now providing a 1A recommendation for intravenous iron in patients with heart failure with reduced ejection fraction (HFrEF) and iron deficiency (ID). However, the findings from randomized controlled trials (RCT) are mixed. This systematic review of RCTs aims to provide an update and synthesize the evidence addressing the association of intravenous iron with patient-based outcomes in patients with HFrEF and ID. METHODS:Any RCT evaluating the effect of intravenous iron in patients with HFrEF and ID was eligible for inclusion. A complete search of the EMBASE and PubMed databases was conducted from inception until 15 September 2023. The primary outcome was the composite of the quality of life (QoL) questionnaires, while the secondary outcomes included first heart failure (HF) hospitalizations and all-cause mortality. Data extraction was performed independently by two reviewers. Data were pooled using a random-effects model. RESULTS:Of the 1035 references, 15 RCTs enrolling 6649 patients were included in this study. Intravenous iron was associated with significant improvement in the composite of QoL (standardized mean difference - 1.36, 95% confidence interval [CI] - 2.24 to - 0.48; p = 0.002), a significant reduction in first HF hospitalizations (hazard ratio [HR] 0.73, 95% CI 0.56-0.95; p = 0.02), and with no change in all-cause mortality (HR 0.90, 95% CI 0.79-1.03; p = 0.12). The certainty of the evidence ranged from moderate to very low. CONCLUSION/CONCLUSIONS:Intravenous iron is possibly associated with improved QoL and reduced HF hospitalizations, without impacting all-cause mortality. These findings not only support the use of intravenous iron in patients with HFrEF but also emphasize the need for well-designed and executed RCTs with granular outcome reporting and powered sufficiently to address the impact of intravenous iron on mortality in patients with HFrEF and ID. REGISTRATION/BACKGROUND:PROSPERO identifier number CRD42023389.
PMID: 38519808
ISSN: 1179-187x
CID: 5641032

Outcomes of Patients With Cancer With Myocardial Infarction-Associated Cardiogenic Shock Managed With Mechanical Circulatory Support

Leiva, Orly; Cheng, Richard K; Pauwaa, Sunil; Katz, Jason N; Alvarez-Cardona, Jose; Bernard, Samuel; Alviar, Carlos; Yang, Eric H
BACKGROUND/UNASSIGNED:Cardiogenic shock (CS) is the leading cause of death among patients with acute myocardial infarction (AMI) and is managed with temporary mechanical circulatory support (tMCS) in advanced cases. Patients with cancer are at high risk of AMI and CS. However, outcomes of patients with cancer and AMI-CS managed with tMCS have not been rigorously studied. METHODS/UNASSIGNED:Adult patients with AMI-CS managed with tMCS from 2006 to 2018 with and without cancer were identified using the National Inpatient Sample. Propensity score matching (PSM) was performed for variables associated with cancer. Primary outcome was in-hospital death, and secondary outcomes were major bleeding and thrombotic complications. RESULTS/UNASSIGNED:< .001). After PSM, there was no difference in in-hospital death (odds ratio [OR], 1.00; 95% CI, 0.88-1.13) or thrombotic complications (OR, 1.10; 95% CI, 0.91-1.34) between patients with and without cancer. Patients with cancer had a higher risk of major bleeding (OR, 1.29; 95% CI, 1.15-1.46). CONCLUSIONS/UNASSIGNED:Among patients with AMI-CS managed with tMCS, cancer is becoming increasingly frequent and associated with increased risk of major bleeding, although there was no difference in in-hospital death. Further studies are needed to further characterize outcomes, and inclusion of patients with cancer in trials of tMCS is needed.
PMCID:11307771
PMID: 39131775
ISSN: 2772-9303
CID: 5726622