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Design and Execution of Clinical Trials in the Cardiac Intensive Care Unit

Pierce, Jacob B; Applefeld, Willard N; Senman, Balimkiz; Loriaux, Daniel B; Lawler, Patrick R; Katz, Jason N
Clinical practice in the contemporary cardiac intensive care unit (CICU) has evolved significantly over the last several decades. With more frequent multisystem organ failure, increasing use of advanced respiratory support, and the advent of new mechanical circulatory support platforms, clinicians in the CICU are increasingly managing patients with complex comorbid disease in addition to their high-acuity cardiovascular illnesses. Here, the authors discuss challenges associated with traditional trial design in the CICU setting and review novel clinical trial designs that may facilitate better evidence generation in the CICU.
PMID: 37973354
ISSN: 1557-8232
CID: 5788392

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

The HFSA Advanced Heart Failure and Transplant Cardiology Fellowship Consensus Conference

Drazner, Mark H; Ambardekar, Amrut V; Berlacher, Kathryn; Blumer, Vanessa; Chatur, Safia; Cheng, Richard; Cheng, Richard K; Grandin, E Wilson; Gorodeski, Eiran Z; Kataria, Rachna; Katz, Jason N; Kittleson, Michelle M; Krishnamoorthy, Arun; Lala, Anuradha; Lenneman, Andrew J; Lohr, Nicole L; Margulies, Kenneth B; Mentz, Robert J; Reza, Nosheen; Wilcox, Jane; Youmans, Quentin R; Zieroth, Shelley; Teerlink, John R
There is waning interest among cardiology trainees in pursuing an Advanced Heart Failure/Transplant Cardiology (AHFTC) fellowship as evidenced by fewer applicants in the National Resident Matching Program match to this specialty. This trend has generated considerable attention across the heart failure community. In response, the Heart Failure Society of America convened the AHFTC Fellowship Task Force with a charge to develop strategies to increase the value proposition of an AHFTC fellowship. Subsequently, the HFSA sponsored the AHFTC Fellowship Consensus Conference April 26-27, 2023. Before the conference, interviews of 44 expert stakeholders diverse across geography, site of practice (traditional academic medical center or other centers), specialty/area of expertise, sex, and stage of career were conducted virtually. Based on these interviews, potential solutions to address the declining interest in AHFTC fellowship were categorized into five themes: (1) alternative training pathways, (2) regulatory and compensation, (3) educational improvements, (4) exposure and marketing for pipeline development, and (5) quality of life and mental health. These themes provided structure to the deliberations of the AHFTC Fellowship Consensus Conference. The recommendations from the Consensus Conference were subsequently presented to the HFSA Board of Directors to inform strategic plans and interventions. The HFSA Board of Directors later reviewed and approved submission of this document. The purpose of this communication is to provide the HF community with an update summarizing the processes used and concepts that emerged from the work of the HFSA AHFTC Fellowship Task Force and Consensus Conference.
PMCID:11540483
PMID: 37806488
ISSN: 1532-8414
CID: 5788362

Long-term predictors of morbidity and mortality in patients following LVAD replacement

Jimenez Contreras, Fabian; Rames, Jess David; Schroder, Jacob; Russell, Stuart D; Katz, Jason; Omer, Tariq; Barac, Yaron D; Milano, Carmelo
BACKGROUND:As heart transplant guidelines evolve, the clinical indication for 73% of durable left ventricular assist device (LVAD) implants is now destination therapy. Although completely magnetically levitated LVAD devices have demonstrated improved durability relative to previous models, LVAD replacement procedures are still required for a variety of indications. Thus, the population of patients with a replaced LVAD is growing. There is a paucity of data regarding the outcomes and risk factors for those patients receiving first-time LVAD replacements. METHODS:The study cohort consisted of all consecutive patients between 2006 and 2020 that received a first-time LVAD replacement at a single institution. Preoperative clinical and laboratory variables were collected retrospectively. The primary endpoint was death or need for an additional LVAD replacement. Data were subjected to Kaplan-Meier, univariate, and multivariate Cox hazard ratio analyses. RESULTS:In total, 152 patients were included in the study, of which 101 experienced the primary endpoint. On multivariate analysis, patients receiving HeartMate 3 (HM3) LVADs as the replacement device showed superior outcomes (HR 0.15, 95% CI 0.065-0.35, p < 0.0001). Independent risk factors for death or need for additional replacement included preoperative extracorporeal membrane oxygenation (ECMO) (HR 4.44, 95% CI 1.87-14.45, and p = 0.00042), increased number of sternotomies (HR 5.20, 95% CI 1.87-14.45, and p = 0.0016), and preoperative mechanical ventilation (HR 1.98, 95% CI 1.01-3.86, and p = 0.045). CONCLUSIONS:Replacement with HM3 showed superior outcomes compared to all other pump types when controlling for both initial pump type and other independent predictors of death or LVAD replacement. Preoperative ECMO, mechanical ventilation, and multiple sternotomies also increased the odds for death or the need for subsequent replacement.
PMID: 37814840
ISSN: 1525-1594
CID: 5783162

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

Comparing Outcomes Between Advanced Practice Providers and Housestaff Teams in the Cardiac Intensive Care Unit

Zhang, Robert S; Zhang, Peter; Bailey, Eric; Ho, Alvin; Rhee, Aaron; Xia, Yuhe; Schimmer, Hannah; Bernard, Samuel; Castillo, Patricio; Grossman, Kelsey; Dai, Matthew; Singh, Arushi; Padilla-Lopez, Mireia; Nunemacher, Kayla; Hall, Sylvie F; Rosenzweig, Barry; Katz, Jason N; Link, Nathan; Keller, Norma; Bangalore, Sripal; Alviar, Carlos L
BACKGROUND/UNASSIGNED:With an increasing demand for critical care expertise and limitations in intensivist availability, innovative staffing models, such as the utilization of advanced practice providers (APPs), have emerged. OBJECTIVES/UNASSIGNED:The purpose of the study was to compare patient outcomes between APP and housestaff teams in the cardiac intensive care unit (CICU). METHODS/UNASSIGNED:This retrospective study, spanning March 2022 to July 2023, compares patient characteristics and outcomes between two CICU teams embedded in the same CICU at a large urban academic hospital: one staffed by housestaff and the other by APPs (80% physician assistants, 20% nurse practitioners) who each had approximately 1 to 2 years of experience in the CICU. The primary outcome was CICU mortality. Multivariable Cox regression analyses and Kaplan-Meier curves were used to assess the primary outcome. RESULTS/UNASSIGNED: < 0.0001). CONCLUSIONS/UNASSIGNED:Our moderately sized study demonstrated no difference in CICU or in-hospital mortality between patients managed by a housestaff team versus those managed by an APP team.
PMCID:11576500
PMID: 39569031
ISSN: 2772-963x
CID: 5758722

'Weekend Effect' in Acute Pulmonary Embolism Management and Outcomes

Mehta, Aryan; Bansal, Mridul; Passey, Siddhant; Joshi, Saurabh; Alviar, Carlos L; Katz, Jason N; Abbott, J Dawn; Vallabhajosyula, Saraschandra
None.
PMID: 39477200
ISSN: 1879-1913
CID: 5747092

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

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

Epidemiology of Cardiogenic Shock Using the Shock Academic Research Consortium (SHARC) Consensus Definitions

Berg, David D; Bohula, Erin A; Patel, Siddharth M; Alfonso, Carlos E; Alviar, Carlos L; Baird-Zars, Vivian M; Barnett, Christopher F; Barsness, Gregory W; Bennett, Courtney E; Chaudhry, Sunit-Preet; Fordyce, Christopher B; Ghafghazi, Shahab; Gidwani, Umesh K; Goldfarb, Michael J; Katz, Jason N; Menon, Venu; Miller, P Elliott; Newby, L Kristin; Papolos, Alexander I; Park, Jeong-Gun; Pierce, Matthew J; Proudfoot, Alastair G; Sinha, Shashank S; Sridharan, Lakshmi; Thompson, Andrea D; van Diepen, Sean; Morrow, David A
BACKGROUND:The Shock Academic Research Consortium (SHARC) recently proposed pragmatic consensus definitions to standardize classification of cardiogenic shock (CS) in registries and clinical trials. We aimed to describe contemporary CS epidemiology using the SHARC definitions in a cardiac intensive care unit (CICU) population. METHODS:The Critical Care Cardiology Trials Network (CCCTN) is a multinational research network of advanced CICUs coordinated by the TIMI Study Group (Boston, MA). CS was defined as a cardiac disorder resulting in SBP<90mmHg for ≥30 minutes (or the need for vasopressors, inotropes, or mechanical circulatory support [MCS] to maintain SBP ≥90mmHg) with evidence of hypoperfusion. Primary etiologic categories included acute myocardial infarction-related CS (AMI-CS), heart failure-related CS (HF-CS), and non-myocardial (secondary) CS. Post-cardiotomy CS was not included. HF-CS was further subcategorized as de novo vs. acute-on-chronic HF-CS. Patients with both cardiogenic and non-cardiogenic components of shock were classified separately as mixed CS. RESULTS:Of 8,974 patients meeting shock criteria (2017-2023), 65% had isolated CS and 17% had mixed shock. Among patients with CS (n=5,869), 27% had AMI-CS (65% STEMI), 59% HF-CS (72% acute-on-chronic, 28% de novo), and 14% secondary CS. Patients with AMI-CS and de novo HF-CS were most likely to have had concomitant cardiac arrest (p<0.001). Patients with AMI-CS and mixed CS were most likely to present in more severe shock stages (SCAI D or E; p<0.001). Temporary MCS use was highest in AMI-CS (59%). In-hospital mortality was highest in mixed CS (48%), followed by AMI-CS (41%), similar in de novo HF-CS (31%) and secondary CS (31%), and lowest in acute-on-chronic HF-CS (25%; p<0.001). CONCLUSIONS:SHARC consensus definitions for CS classification can be pragmatically applied in contemporary registries and reveal discrete subpopulations of CS with distinct phenotypes and outcomes that may be relevant to clinical practice and future research.
PMID: 39208447
ISSN: 2048-8734
CID: 5729932