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Standardized Definitions for Evaluation of Acute Decompensated Heart Failure Therapies: HF-ARC Expert Panel Paper

Lala, Anuradha; Hamo, Carine E; Bozkurt, Biykem; Fiuzat, Mona; Blumer, Vanessa; Bukhoff, Daniel; Butler, Javed; Costanzo, Maria Rosa; Felker, G Michael; Filippatos, Gerasimos; Konstam, Marvin A; McMurray, John J V; Mentz, Robert J; Metra, Marco; Psotka, Mitchell A; Solomon, Scott D; Teerlink, John; Abraham, William T; O'Connor, Christopher M; ,
Acute decompensated heart failure (ADHF) is one of the most common reasons for hospitalizations or urgent care and is associated with poor outcomes. Therapies shown to improve outcomes are limited, however, and innovation in pharmacologic and device-based therapeutics are therefore actively being sought. Standardizing definitions for ADHF and its trajectory is complex, limiting the generalizability and translation of clinical trials to effect clinical care and policy change. The Heart Failure Collaboratory is a multi-stakeholder organization comprising clinical investigators, clinicians, patients, government representatives (including U.S. Food and Drug Administration and National Institutes of Health participants), payors, and industry collaborators. The following expert consensus document is the product of the Heart Failure Collaboratory convening with the Academic Research Consortium, including members from academia, the U.S. Food and Drug Administration, and industry, for the purposes of proposing standardized definitions for ADHF and highlighting important endpoint considerations to inform the design and conduct of clinical trials for drugs and devices in this clinical arena.
PMID: 38069997
ISSN: 2213-1787
CID: 5589772

A Roadmap to Reinvigorating Training Pathways Focused on the Care of Patients With Heart Failure: Shifting From Failure to Function

Blumer, Vanessa; Kittleson, Michelle M; Teerlink, John R; Drazner, Mark H; Walsh, Mary N; Gorodeski, Eiran Z; Mentz, Robert J; Lala, Anuradha
PMID: 36610557
ISSN: 1532-8414
CID: 5506142

Vaccines, Antibodies and Donors: Varying Attitudes and Policies Surrounding COVID-19 and Heart Transplantation

Defilippis, Ersilia M; Allen, Larry A; Bhatt, Ankeet S; Joseph, Susan; Kittleson, Michelle; Vardeny, Orly; Drazner, Mark H; Lala, Anuradha
INTRODUCTION/BACKGROUND:There are varied opinions in the United States regarding many aspects of care related to COVID-19. The purpose of this study was to examine the opinions of health care personnel and the policies of heart transplant centers concerning practices for the prevention and treatment of COVID-19 in donors and recipients of heart transplants. METHODS:Two anonymous, electronic web-based surveys were developed: 1 was administered to health care personnel through a mailing list maintained by the Heart Failure Society of America (HFSA); another was administered to U.S. medical adult and pediatric heart transplant (HT) program directors. Individual and group e-mails were sent with an embedded link to the respective surveys in February 2022. RESULTS:A total of 176 individuals (8.6%) responded to the survey administered through the HFSA. Of medical directors of transplant programs, 78 (54% response rate) completed a separate survey on their centers' policies. Although 95% (n = 167) of individuals indicated vaccination against COVID-19 should be required prior to HT, only 67% (n = 52) of centers mandated that practice. Similarly, 61% of individuals thought vaccination should be required prior to HT for caregivers, but only 13% of transplant centers mandated caregiver vaccination. Of the centers, 63% reported considering donors despite histories of recent COVID-19 infection (within 3 months), and 47% considered donors with current positive polymerase chain reaction tests. Regarding post-transplant care, only 22% of programs routinely measured antibodies to COVID-19, and 71% used tixagevimab/cilgavimab (Evusheld) for pre-exposure prophylaxis. CONCLUSIONS:There were significant differences between individual preferences and centers' practices with respect to COVID-19 management of candidates for and recipients of HT. Additionally, there was wide variation in policies among centers, reflecting the need for further study to inform consistent guidance and recommendations across centers to optimize equitable care for this high-risk patient population.
PMCID:9212876
PMID: 35718306
ISSN: 1532-8414
CID: 5413172

Recognizing Efforts that Support Clinical Trial Success: Site-Based Research Awards from the Heart Failure Collaboratory and Heart Failure Society of America [Editorial]

Lala, Anuradha; O'Connor, Christopher M; Fiuzat, Mona; Drazner, Mark H; Mentz, Robert J
PMID: 36113899
ISSN: 1532-8414
CID: 5342022

Frailty Measures of Patient-reported Activity and Fatigue May Predict 1-year Outcomes in Ambulatory Advanced Heart Failure: A Report From the REVIVAL Registry

Lala, Anuradha; Shah, Palak; Khalatbari, Shokoufeh; Yosef, Matheos; Mountis, Maria M; Robinson, Shawn W; Lanfear, David E; Estep, Jerry D; Jeffries, Neal; Taddei-Peters, Wendy C; Stevenson, Lynne W; Richards, Blair; Mann, Douglas L; Mancini, Donna M; Stewart, Garrick C; Aaronson, Keith D
BACKGROUND:The Fried Frailty Phenotype predicts adverse outcomes in geriatric populations, but has not been well-studied in advanced heart failure (HF). The Registry Evaluation of Vital Information for Ventricular Assist Devices (VADs) in Ambulatory Life (REVIVAL) study prospectively collected frailty measures in patients with advanced HF to determine relevant assessments and their impact on clinical outcomes. METHODS AND RESULTS/RESULTS:HF-Fried Frailty was defined by 5 baseline components (1 point each): (1) weakness: hand grip strength less than 25% of body weight; (2) slowness based on time to walk 15 feet; (3) weight loss of more than 10 lbs in the past year; (4) inactivity; and (5) exhaustion, both assessed by the Kansas City Cardiomyopathy Questionnaire. A score of 0 or 1 was deemed nonfrail, 2 prefrail, and 3 or greater was considered frail. The primary composite outcome was durable mechanical circulatory support implantation, cardiac transplant or death at 1 year. Event-free survival for each group was determined by the Kaplan-Meier method and the hazard of prefrailty and frailty were compared with nonfrailty with proportional hazards modeling. Among 345 patients with all 5 frailty domains assessed, frailty was present in 17%, prefrailty in 40%, and 43% were nonfrail, with 67% (n = 232) meeting the criteria based on inactivity and 54% (n = 186) for exhaustion. Frail patients had an increased risk of the primary composite outcome (unadjusted hazard ratio [HR] 2.82, 95% confidence interval [CI] 1.52-5.24; adjusted HR 3.41, 95% CI 1.79-6.52), as did prefrail patients (unadjusted HR 1.97, 95% CI 1.14-3.41; adjusted HR 2.11, 95% CI 1.21-3.66) compared with nonfrail patients, however, the predictive value of HF-Fried Frailty criteria was modest (Harrel's C-statistic of 0.603, P = .004). CONCLUSIONS:The HF-Fried Frailty criteria had only modest predictive power in identifying ambulatory patients with advanced HF at high risk for durable mechanical circulatory support, transplant, or death within 1 year, driven primarily by assessments of inactivity and exhaustion. Focus on these patient-reported measures may better inform clinical trajectories in this population.
PMID: 34961663
ISSN: 1532-8414
CID: 5100102

Sex Differences in Heart Failure

Lala, Anuradha; Tayal, Upasana; Hamo, Carine E; Youmans, Quentin; Al-Khatib, Sana M; Bozkurt, Biykem; Davis, Melinda B; Januzzi, James; Mentz, Robert; Sauer, Andrew; Walsh, Mary Norine; Yancy, Clyde; Gulati, Martha
Heart failure (HF) continues to be a major contributor of morbidity and mortality for men and women alike, yet how the predisposition for, course and management of HF differ between men and women remains underexplored. Sex differences in traditional risk factors as well as sex-specific risk factors influence the prevalence and manifestation of HF in unique ways. The pathophysiology of HF differs between men and women and may explain sex-specific differences in clinical presentation and diagnosis. This in turn, contributes to variation in response to both pharmacologic and device/surgical therapy. This review examines sex-specific differences in HF spanning prevalence, risk factors, pathophysiology, presentation, and therapies with a specific focus on highlighting gaps in knowledge with calls to action for future research efforts.
PMID: 34774749
ISSN: 1532-8414
CID: 5234622

Effect of Treatment With Sacubitril/Valsartan in Patients With Advanced Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial

Mann, Douglas L; Givertz, Michael M; Vader, Justin M; Starling, Randall C; Shah, Palak; McNulty, Steven E; Anstrom, Kevin J; Margulies, Kenneth B; Kiernan, Michael S; Mahr, Claudius; Gupta, Divya; Redfield, Margaret M; Lala, Anuradha; Lewis, Gregory D; DeVore, Adam D; Desvigne-Nickens, Patrice; Hernandez, Adrian F; Braunwald, Eugene
Importance/UNASSIGNED:The use of sacubitril/valsartan is not endorsed by practice guidelines for use in patients with New York Heart Association class IV heart failure with a reduced ejection fraction because of limited clinical experience in this population. Objective/UNASSIGNED:To compare treatment with sacubitril/valsartan treatment with valsartan in patients with advanced heart failure and a reduced ejection fraction and recent New York Heart Association class IV symptoms. Design, Setting, and Participants/UNASSIGNED:A double-blind randomized clinical trial was conducted; a total of 335 patients with advanced heart failure were included. The trial began on March 2, 2017, and was stopped early on March 23, 2020, owing to COVID-19 risk. Intervention/UNASSIGNED:Patients were randomized to receive sacubitril/valsartan (target dose, 200 mg twice daily) or valsartan (target dose, 160 mg twice daily) in addition to recommended therapy. Main Outcomes and Measures/UNASSIGNED:The area under the curve (AUC) for the ratio of N-terminal pro-brain natriuretic peptide (NT-proBNP) compared with baseline measured through 24 weeks of therapy. Results/UNASSIGNED:Of the 335 patients included in the analysis, 245 were men (73%); mean (SD) age was 59.4 (13.5) years. Seventy-two eligible patients (18%) were not able to tolerate sacubitril/valsartan, 100 mg/d, during the short run-in period, and 49 patients (29%) discontinued sacubitril/valsartan during the 24 weeks of the trial. The median NT-proBNP AUC for the valsartan treatment arm (n = 168) was 1.19 (IQR, 0.91-1.64), whereas the AUC for the sacubitril/valsartan treatment arm (n = 167) was 1.08 (IQR, 0.75-1.60). The estimated ratio of change in the NT-proBNP AUC was 0.95 (95% CI 0.84-1.08; P = .45). Compared with valsartan, treatment with sacubitril/valsartan did not improve the clinical composite of number of days alive, out of hospital, and free from heart failure events. Aside from a statistically significant increase in non-life-threatening hyperkalemia in the sacubitril/valsartan arm (28 [17%] vs 15 [9%]; P = .04), there were no observed safety concerns. Conclusions and Relevance/UNASSIGNED:The findings of this trial showed that, in patients with chronic advanced heart failure with a reduced ejection fraction, there was no statistically significant difference between sacubitril/valsartan and valsartan with respect to reducing NT-proBNP levels. Trial Registration/UNASSIGNED:ClinicalTrials.gov Identifier: NCT02816736.
PMCID:8567189
PMID: 34730769
ISSN: 2380-6591
CID: 5090732

Coronavirus Disease-2019 and Heart Failure: A Scientific Statement From the Heart Failure Society of America

Bhatt, Ankeet S; Adler, Eric D; Albert, Nancy M; Anyanwu, Anelechi; Bhadelia, Nahid; Cooper, Leslie T; Correa, Ashish; Defilippis, Ersilia M; Joyce, Emer; Sauer, Andrew J; Solomon, Scott D; Vardeny, Orly; Yancy, Clyde; Lala, Anuradha
PMCID:8408888
PMID: 34481067
ISSN: 1532-8414
CID: 5136602

COVID-19 in solid organ transplant: A multi-center cohort study

Kates, Olivia S; Haydel, Brandy M; Florman, Sander S; Rana, Meenakshi M; Chaudhry, Zohra S; Ramesh, Mayur S; Safa, Kassem; Kotton, Camille Nelson; Blumberg, Emily A; Besharatian, Behdad D; Tanna, Sajal D; Ison, Michael G; Malinis, Maricar; Azar, Marwan M; Rakita, Robert M; Morillas, Jose A; Majeed, Aneela; Sait, Afrah S; Spaggiari, Mario; Hemmige, Vagish; Mehta, Sapna A; Neumann, Henry; Badami, Abbasali; Goldman, Jason D; Lala, Anuradha; Hemmersbach-Miller, Marion; McCort, Margaret E; Bajrovic, Valida; Ortiz-Bautista, Carlos; Friedman-Moraco, Rachel; Sehgal, Sameep; Lease, Erika D; Fisher, Cynthia E; Limaye, Ajit P
BACKGROUND:The COVID-19 pandemic has led to significant reductions in transplantation, motivated in part by concerns of disproportionately more severe disease among solid organ transplant (SOT) recipients. However, clinical features, outcomes, and predictors of mortality in SOT recipients are not well-described. METHODS:We performed a multi-center cohort study of SOT recipients with laboratory-confirmed COVID-19. Data were collected using standardized intake and 28-day follow-up electronic case report forms. Multivariable logistic regression was used to identify risk factors for the primary endpoint, 28-day mortality, among hospitalized patients. RESULTS:Four hundred eighty-two SOT recipients from >50 transplant centers were included: 318 (66%) kidney or kidney/pancreas, 73 (15.1%) liver, 57 (11.8%) heart, and 30 (6.2%) lung. Median age was 58 (IQR 46-57), median time post-transplant was 5 years (IQR 2-10), 61% were male, and 92% had ≥1 underlying comorbidity. Among those hospitalized (376 [78%]), 117 (31%) required mechanical ventilation, and 77 (20.5%) died by 28 days after diagnosis. Specific underlying comorbidities (age >65 [aOR 3.0, 95%CI 1.7-5.5, p<0.001], congestive heart failure [aOR 3.2, 95%CI 1.4-7.0, p=0.004], chronic lung disease [aOR 2.5, 95%CI 1.2-5.2, p=0.018], obesity [aOR 1.9, 95% CI 1.0-3.4, p=0.039]) and presenting findings (lymphopenia [aOR 1.9, 95%CI 1.1-3.5, p=0.033], abnormal chest imaging [aOR 2.9, 95%CI 1.1-7.5, p=0.027]) were independently associated with mortality. Multiple measures of immunosuppression intensity were not associated with mortality. CONCLUSIONS:Mortality among SOT recipients hospitalized for COVID-19 was 20.5%. Age and underlying comorbidities rather than immunosuppression intensity-related measures were major drivers of mortality.
PMCID:7454362
PMID: 32766815
ISSN: 1537-6591
CID: 4652602

Risk for non-home discharge following surgery for ischemic mitral valve disease

Lala, Anuradha; Chang, Helena L; Liu, Xiaoyu; Charles, Eric J; Yerokun, Babatunde A; Bowdish, Michael E; Thourani, Vinod H; Mack, Michael J; Miller, Marissa A; O'Gara, Patrick T; Blackstone, Eugene H; Moskowitz, Alan J; Gelijns, Annetine C; Mullen, John C; Stevenson, Lynne W; DeRose, Joseph J; Wang, Alice; Smith, Peter K; Acker, Michael A; Ailawadi, Gorav; Miller, Marissa A; Taddei-Peters, Wendy C; Buxton, Dennis; Caulder, Ron; Geller, Nancy L; Gordon, David; Jeffries, Neal O; Lee, Albert; Gombos, Ilana Kogan; Ralph, Jennifer; Weisel, Richard D; Gardner, Timothy J; O'Gara, Patrick T; Rose, Eric A; Gelijns, Annetine C; Parides, Michael K; Ascheim, Deborah D; Moskowitz, Alan J; Bagiella, Emilia; Moquete, Ellen; Chang, Helena; Chase, Melissa; Foo, James; Chen, Yingchun; Goldfarb, Seth; Gupta, Lopa; Kirkwood, Katherine; Dobrev, Edlira; Levitan, Ron; O'Sullivan, Karen; Overbey, Jessica; Santos, Milerva; Williams, Deborah; Weglinski, Michael; Williams, Paula; Wood, Carrie; Ye, Xia; Nielsen, Sten Lyager; Wiggers, Henrik; Malgaard, Henning; Mack, Michael; Adame, Tracine; Settele, Natalie; Adams, Jenny; Ryan, William; Smith, Robert L; Grayburn, Paul; Chen, Frederick Y; Nohria, Anju; Cohn, Lawrence; Shekar, Prem; Aranki, Sary; Couper, Gregory; Davidson, Michael; Bolman, R Morton 3rd; Burgess, Anne; Conboy, Debra; Lawrence, Rita; Noiseux, Nicolas; Stevens, Louis-Mathieu; Prieto, Ignacio; Basile, Fadi; Dionne, Joannie; Fecteau, Julie; Blackstone, Eugene H; Gillinov, A Marc; Lackner, Pamela; Berroteran, Leoma; Dolney, Diana; Fleming, Suzanne; Palumbo, Roberta; Whitman, Christine; Sankovic, Kathy; Sweeney, Denise Kosty; Geither, Carrie; Doud, Kristen; Pattakos, Gregory; Clarke, Pamela A; Argenziano, Michael; Williams, Mathew; Goldsmith, Lyn; Smith, Craig R; Naka, Yoshifumi; Stewart, Allan; Schwartz, Allan; Bell, Daniel; Van Patten, Danielle; Sreekanth, Sowmya; Wang, Alice; Alexander, John H; Milano, Carmelo A; Glower, Donald D; Mathew, Joseph P; Harrison, J Kevin; Welsh, Stacey; Berry, Mark F; Parsa, Cyrus J; Tong, Betty C; Williams, Judson B; Ferguson, T Bruce; Kypson, Alan P; Rodriguez, Evelio; Harris, Malissa; Akers, Brenda; O'Neal, Allison; Puskas, John D; Thourani, Vinod H; Guyton, Robert; Baer, Jefferson; Baio, Kim; Neill, Alexis A; Voisine, Pierre; Senechal, Mario; Dagenais, François; O'Connor, Kim; Dussault, Gladys; Ballivian, Tatiana; Keilani, Suzanne; Speir, Alan M; Magee, Patrick; Ad, Niv; Keyte, Sally; Dang, Minh; Slaughter, Mark; Headlee, Marsha; Moody, Heather; Solankhi, Naresh; Birks, Emma; Groh, Mark A; Shell, Leslie E; Shepard, Stephanie A; Trichon, Benjamin H; Nanney, Tracy; Hampton, Lynne C; Mangusan, Ralph; Michler, Robert E; D'Alessandro, David A; DeRose, Joseph J Jr; Goldstein, Daniel J; Bello, Ricardo; Jakobleff, William; Garcia, Mario; Taub, Cynthia; Spevak, Daniel; Swayze, Roger; Sookraj, Nadia; Perrault, Louis P; Basmadjian, Arsène-Joseph; Bouchard, Denis; Carrier, Michel; Cartier, Raymond; Pellerin, Michel; Tanguay, Jean François; El-Hamamsy, Ismail; Denault, André; Demers, Philippe; Jonathan Lacharité, Sophie Robichaud; Horvath, Keith A; Corcoran, Philip C; Siegenthaler, Michael P; Murphy, Mandy; Iraola, Margaret; Greenberg, Ann; Sai-Sudhakar, Chittoor; Hasan, Ayseha; McDavid, Asia; Kinn, Bradley; Pagé, Pierre; Sirois, Carole; Latter, David; Leong-Poi, Howard; Bonneau, Daniel; Errett, Lee; Peterson, Mark D; Verma, Subodh; Feder-Elituv, Randi; Cohen, Gideon; Joyner, Campbell; Fremes, Stephen E; Moussa, Fuad; Christakis, George; Karkhanis, Reena; Yau, Terry; Farkouh, Michael; Woo, Anna; Cusimano, Robert James; David, Tirone; Feindel, Christopher; Garrard, Lisa; Fredericks, Suzanne; Mociornita, Amelia; Mullen, John C; Choy, Jonathan; Meyer, Steven; Kuurstra, Emily; Gammie, James S; Young, Cindi A; Beach, Dana; Villanueva, Robert; Atluri, Pavan; Woo, Y Joseph; Mayer, Mary Lou; Bowdish, Michael; Starnes, Vaughn A; Shavalle, David; Matthews, Ray; Javadifar, Shadi; Romar, Linda; Kron, Irving L; Ailawadi, Gorav; Johnston, Karen; Dent, John M; Kern, John; Keim, Jessica; Burks, Sandra; Gahring, Kim; Bull, David A; Dixon, Dennis O; Haigney, Mark; Holubkov, Richard; Jacobs, Alice; Miller, Frank; Murkin, John M; Spertus, John; Wechsler, Andrew S; Sellke, Frank; Byington, Robert; Dickert, Neal; Ikonomidis, John S; Williams, David O; Yancy, Clyde W; Fang, James C; Giannetti, Nadia; Richenbacher, Wayne; Rao, Vivek; Furie, Karen L; Miller, Rachel; Pinney, Sean; Roberts, William C; Walsh, Mary N; Hung, Judy; Zeng, Xin; Kilcullen, Niamh; Hung, David; Keteyian, Stephen J; Brawner, Clinton A; Aldred, Heather; Browndyke, Jeffrey; Toulgoat-Dubois, Yanne
OBJECTIVES/OBJECTIVE:To determine the frequency and risk factors for non-home discharge (NHD) and its association with clinical outcomes and quality of life (QOL) at 1 year following cardiac surgery in patients with ischemic mitral regurgitation (IMR). METHODS:Discharge disposition was evaluated in 552 patients enrolled in trials of severe or moderate IMR. Patient and in-hospital factors associated with NHD were identified using logistic regression. Subsequently, association of NHD with 1-year mortality, serious adverse events (SAEs), and QOL was assessed. RESULTS:NHD was observed in 30% (154/522) with 25% (n = 71/289) in moderate and 36% (n = 83/233) in patients with severe IMR (unadjusted P = .006), a difference not significant after including age (5-year change: adjusted odds ratio [adjOR], 1.52; 95% confidence interval [CI], 1.35-1.72; P < .001), diabetes (adjOR, 1.94; 95% CI, 1.27-2.94; P = .002), and previous heart failure (adjOR, 1.64; 95% CI, 1.06-2.52; P = .03). Odds of NHD were increased for patients with postoperative SAEs (adjOR, 1.85; 95% CI, 1.19-2.86; P = .01) but not based on type of cardiac surgery. Greater rates of death and SAEs were observed in NHD patients at 1 year: adjusted hazard ratio, 4.29 (95% CI, 2.14-8.59; P < .001) and adjusted rate ratio, 1.45 (95% CI, 1.03-2.02; P = .03), respectively. QOL did not differ significantly between groups. CONCLUSIONS:NHD is common following surgery for IMR, influenced by older age, diabetes, previous heart failure, and postoperative SAEs. These patients may be at greater risk of death and subsequent SAEs after discharge. Discussion of NHD with patients may have important implications for decision-making and guiding expectations following cardiac surgery.
PMID: 32307181
ISSN: 1097-685x
CID: 5451222