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2. 43017 Learning about Adaptive Capacity and Preparedness of CTSA Hubs

Author

Boris Volkov, Bart Ragon, Jamie Doyle, Miriam A. Bredella, Sandra Burks, Gaurav Dave, Keith Herzog, Kristi Holmes, Veronica Hoyo, Joe Hunt, Cathleen Kane, Wayne T. McCormack, Tanha Patel, Chris Pulley, Anne Seymour, Raj C. Shah, Laura Viera, and Anita Walden

Subjects
Medicine
Abstract

ABSTRACT IMPACT: This work will inform the ongoing development of adaptive capacity and preparedness of the CTSA Program and other clinical and translational research organizations in their quest of improving processes that drive outcomes and impacts, shaping effective programs and services, and strengthening their emergency readiness and sustainability. OBJECTIVES/GOALS: -Share the progress and preliminary findings of an ‘Adaptive Capacity and Preparedness of CTSA Hubs’ CTSA Working Group; -Improve our awareness and understanding of the efficient and effective changes helping CTSA hubs build robust capacity to address METHODS/STUDY POPULATION: A multi-case study including: - Triangulating multiple sources of information and mixed methods (survey/interviews of research administrators, researchers, evaluators, and other key stakeholders), literature review, document and M&E system information analysis, and expert review; - Describing CTSA hubs’ experiences as related to research implementation, translation, and support during the time of emergency; - Administering a comprehensive survey of the CTSAs addressing their challenges, lessons learned, and practices that work in various program components/areas. Data collection includes aggregate and cross-sectional data, with representation based on CTSA size, maturity, and population density. RESULTS/ANTICIPATED RESULTS: The described approach shows sound promise to investigate and share strategies and best practices for building adaptive capacity and preparedness of CTSAs -- across various scientific sectors, translational research spectrum, and the goals outlined by NCATS for the CTSA program. The anticipated results of this research will include the identified/shared innovative solutions and lessons learned for this rapidly emerging, high-priority clinical and translational science issue. ‘High-quality lessons learned’ are those that represent principles extrapolated from multiple sources and triangulated to increase transferability to new contexts and situations. DISCUSSION/SIGNIFICANCE OF FINDINGS: The project provides useful knowledge and tools to research organizations and stakeholders across multiple disciplines -- for mitigating the impact of the COVID-19 disaster via effective adjusting programs, practices, and processes, and building capacity for future successful, ‘emergency ready and responsive’ research and training.

Published
2021
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3. 3416 Building Resilience & Wisdom in Clinical and Translational Researchers: A Mixed-Method Study of a Pilot Curricular Intervention

Author

Sandra Burks, Karen Johnston, Nicole Chiotta-McCollum, Natalie May, John Schorling, and Margaret Plews-Ogan

Subjects
Medicine
Abstract

OBJECTIVES/SPECIFIC AIMS: The clinical and translational research workforce is in jeopardy due to investigator attrition and competing demands upon researchers. Resilience and wisdom are measurable traits that can be acquired. The aim of this study was to examine a pilot curricular intervention promoting resilience and wisdom formation in early-career translational researchers. METHODS/STUDY POPULATION: We conducted a prospective, mixed-methods evaluation of a curricular intervention promoting the development of wisdom and resilience among junior faculty in a career development program. Six 90 minute sessions were delivered between September 2017 and January 2018. Pre- and post- resilience and wisdom were measured using the Connor Davidson Resilience Scale and 3D-Wisdom Scale. Individual semi-structured interviews were conducted before and after the intervention RESULTS/ANTICIPATED RESULTS: Five scholars participated. Median resilience and wisdom scores revealed moderate levels of each trait; pre- and post-scores were not significantly different. Four themes emerged from the analysis of interview transcripts: 1. “Success” broadly defined; 2. Adversity threatens success; 3. Community breeds resilience; and 4. Wisdom formation parallels growth towards independence. DISCUSSION/SIGNIFICANCE OF IMPACT: An intervention aimed at developing capacities of resilience and wisdom is feasibly delivered to early career researchers. The relationship between these capacities and the sustainability of a research career warrants additional study.

Published
2019
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4. Progression of Tricuspid Regurgitation After Surgery for Ischemic Mitral Regurgitation

Author

Philippe B. Bertrand, Jessica R. Overbey, Xin Zeng, Robert A. Levine, Gorav Ailawadi, Michael A. Acker, Peter K. Smith, Vinod H. Thourani, Emilia Bagiella, Marissa A. Miller, Lopa Gupta, Michael J. Mack, A. Marc Gillinov, Gennaro Giustino, Alan J. Moskowitz, Annetine C. Gelijns, Michael E. Bowdish, Patrick T. O’Gara, James S. Gammie, Judy Hung, Wendy C. Taddei-Peters, Dennis Buxton, Ron Caulder, Nancy L. Geller, David Gordon, Neal O. Jeffries, Albert Lee, Claudia S. Moy, Ilana Kogan Gombos, Jennifer Ralph, Richard D. Weisel, Timothy J. Gardner, Eric A. Rose, Michael K. Parides, Deborah D. Ascheim, Ellen Moquete, Helena Chang, Melissa Chase, James Foo, Yingchun Chen, Seth Goldfarb, Katherine Kirkwood, Edlira Dobrev, Ron Levitan, Karen O’Sullivan, Jessica Overbey, Milerva Santos, Deborah Williams, Michael Weglinski, Paula Williams, Carrie Wood, Xia Ye, Sten Lyager Nielsen, Henrik Wiggers, Henning Malgaard, Michael Mack, Tracine Adame, Natalie Settele, Jenny Adams, William Ryan, Robert L. Smith, Paul Grayburn, Frederick Y. Chen, Anju Nohria, Lawrence Cohn, Prem Shekar, Sary Aranki, Gregory Couper, Michael Davidson, R. Morton Bolman, Anne Burgess, Debra Conboy, Rita Lawrence, Nicolas Noiseux, Louis-Mathieu Stevens, Ignacio Prieto, Fadi Basile, Joannie Dionne, Julie Fecteau, Eugene H. Blackstone, Pamela Lackner, Leoma Berroteran, Diana Dolney, Suzanne Fleming, Roberta Palumbo, Christine Whitman, Kathy Sankovic, Denise Kosty Sweeney, Carrie Geither, Kristen Doud, Gregory Pattakos, Pamela A. Clarke, Michael Argenziano, Mathew Williams, Lyn Goldsmith, Craig R. Smith, Yoshifumi Naka, Allan Stewart, Allan Schwartz, Daniel Bell, Danielle Van Patten, Sowmya Sreekanth, John H. Alexander, Carmelo A. Milano, Donald D. Glower, Joseph P. Mathew, J. Kevin Harrison, Stacey Welsh, Mark F. Berry, Cyrus J. Parsa, Betty C. Tong, Judson B. Williams, T. Bruce Ferguson, Alan P. Kypson, Evelio Rodriguez, Malissa Harris, Brenda Akers, Allison O'Neal, John D. Puskas, Robert Guyton, Jefferson Baer, Kim Baio, Alexis A. Neill, Pierre Voisine, Mario Senechal, François Dagenais, Kim O’Connor, Gladys Dussault, Tatiana Ballivian, Suzanne Keilani, Alan M. Speir, Patrick Magee, Niv Ad, Sally Keyte, Minh Dang, Mark Slaughter, Marsha Headlee, Heather Moody, Naresh Solankhi, Emma Birks, Mark A. Groh, Leslie E. Shell, Stephanie A. Shepard, Benjamin H. Trichon, Tracy Nanney, Lynne C. Hampton, Ralph Mangusan, Robert E. Michler, David A. D'Alessandro, Joseph J. DeRose, Daniel J. Goldstein, Ricardo Bello, William Jakobleff, Mario Garcia, Cynthia Taub, Daniel Spevak, Roger Swayze, Nadia Sookraj, Louis P. Perrault, Arsène-Joseph Basmadjian, Denis Bouchard, Michel Carrier, Raymond Cartier, Michel Pellerin, Jean François Tanguay, Ismail El-Hamamsy, André Denault, Philippe Demers, Sophie Robichaud Jonathan Lacharité, Keith A. Horvath, Philip C. Corcoran, Michael P. Siegenthaler, Mandy Murphy, Margaret Iraola, Ann Greenberg, Chittoor Sai-Sudhakar, Ayseha Hasan, Asia McDavid, Bradley Kinn, Pierre Pagé, Carole Sirois, David Latter, Howard Leong-Poi, Daniel Bonneau, Lee Errett, Mark D. Peterson, Subodh Verma, Randi Feder-Elituv, Gideon Cohen, Campbell Joyner, Stephen E. Fremes, Fuad Moussa, George Christakis, Reena Karkhanis, Terry Yau, Michael Farkouh, Anna Woo, Robert James Cusimano, Tirone David, Christopher Feindel, Lisa Garrard, Suzanne Fredericks, Amelia Mociornita, John C. Mullen, Jonathan Choy, Steven Meyer, Emily Kuurstra, Cindi A. Young, Dana Beach, Robert Villanueva, Pavan Atluri, Y. Joseph Woo, Mary Lou Mayer, Michael Bowdish, Vaughn A. Starnes, David Shavalle, Ray Matthews, Shadi Javadifar, Linda Romar, Irving L. Kron, Karen Johnston, John M. Dent, John Kern, Jessica Keim, Sandra Burks, Kim Gahring, David A. Bull, Patrice Desvigne-Nickens, Dennis O. Dixon, Mark Haigney, Richard Holubkov, Alice Jacobs, Frank Miller, John M. Murkin, John Spertus, Andrew S. Wechsler, Frank Sellke, Cheryl L. McDonald, Robert Byington, Neal Dickert, John S. Ikonomidis, David O. Williams, Clyde W. Yancy, James C. Fang, Nadia Giannetti, Wayne Richenbacher, Vivek Rao, Karen L. Furie, Rachel Miller, Sean Pinney, William C. Roberts, Mary N. Walsh, Niamh Kilcullen, David Hung, Stephen J. Keteyian, Clinton A. Brawner, Heather Aldred, Jeffrey Browndyke, and Yanne Toulgoat-Dubois

Subjects
Male, Pacemaker, Artificial, medicine.medical_specialty, medicine.medical_treatment, Myocardial Ischemia, 030204 cardiovascular system & hematology, Severity of Illness Index, 03 medical and health sciences, 0302 clinical medicine, Recurrence, medicine, Humans, Clinical significance, Prospective Studies, 030212 general & internal medicine, Stroke, Aged, Heart Failure, Mitral valve repair, business.industry, Area under the curve, Mitral Valve Insufficiency, Atrial fibrillation, medicine.disease, Tricuspid Valve Insufficiency, Defibrillators, Implantable, Surgery, Hospitalization, Echocardiography, Heart failure, Disease Progression, Female, Tricuspid Valve, Tricuspid Valve Regurgitation, Cardiology and Cardiovascular Medicine, Mitral valve regurgitation, business, Follow-Up Studies
Abstract

Whether to repair nonsevere tricuspid regurgitation (TR) during surgery for ischemic mitral valve regurgitation (IMR) remains uncertain.The goal of this study was to investigate the incidence, predictors, and clinical significance of TR progression and presence of ≥moderate TR after IMR surgery.Patients (n = 492) with untreated nonsevere TR within 2 prospectively randomized IMR trials were included. Key outcomes were TR progression (either progression by ≥2 grades, surgery for TR, or severe TR at 2 years) and presence of ≥moderate TR at 2 years.Patients' mean age was 66 ± 10 years (67% male), and TR distribution was 60% ≤trace, 31% mild, and 9% moderate. Among 2-year survivors, TR progression occurred in 20 (6%) of 325 patients. Baseline tricuspid annular diameter (TAD) was not predictive of TR progression. At 2 years, 37 (11%) of 323 patients had ≥moderate TR. Baseline TR grade, indexed TAD, and surgical ablation for atrial fibrillation were independent predictors of ≥moderate TR. However, TAD alone had poor discrimination (area under the curve, ≤0.65). Presence of ≥moderate TR at 2 years was higher in patients with MR recurrence (20% vs. 9%; p = 0.02) and a permanent pacemaker/defibrillator (19% vs. 9%; p = 0.01). Clinical event rates (composite of ≥1 New York Heart Association functional class increase, heart failure hospitalization, mitral valve surgery, and stroke) were higher in patients with TR progression (55% vs. 23%; p = 0.003) and ≥moderate TR at 2 years (38% vs. 22%; p = 0.04).After IMR surgery, progression of unrepaired nonsevere TR is uncommon. Baseline TAD is not predictive of TR progression and is poorly discriminative of ≥moderate TR at 2 years. TR progression and presence of ≥moderate TR are associated with clinical events. (Comparing the Effectiveness of a Mitral Valve Repair Procedure in Combination With Coronary Artery Bypass Grafting [CABG] Versus CABG Alone in People With Moderate Ischemic Mitral Regurgitation, NCT00806988; Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation, NCT00807040).

Published
2021

5. The impact of perioperative stroke and delirium on outcomes after surgical aortic valve replacement

Author

Steven R. Messé, Jessica R. Overbey, Vinod H. Thourani, Alan J. Moskowitz, Annetine C. Gelijns, Mark A. Groh, Michael J. Mack, Gorav Ailawadi, Karen L. Furie, Andrew M. Southerland, Michael L. James, Claudia Scala Moy, Lopa Gupta, Pierre Voisine, Louis P. Perrault, Michael E. Bowdish, A. Marc Gillinov, Patrick T. O'Gara, Maral Ouzounian, Bryan A. Whitson, John C. Mullen, Marissa A. Miller, James S. Gammie, Stephanie Pan, Guray Erus, Jeffrey N. Browndyke, Wendy C. Taddei-Peters, Neal O. Jeffries, Dennis Buxton, Nancy L. Geller, David Gordon, Catherine Burke, Albert Lee, Tyrone Smith, Claudia S. Moy, Ilana Kogan Gombos, Richard Weisel, Timothy J. Gardner, Eric A. Rose, Michael K. Parides, Deborah D. Ascheim, Emilia Bagiella, Ellen Moquete, Kinjal Shah, Helena Chang, Melissa Chase, Seth Goldfarb, Katherine Kirkwood, Edlira Dobrev, Ron Levitan, Karen O'Sullivan, Milerva Santos, Xia Ye, Michael Mack, Rachelle Winkle, Haley Boswell, Amanda Fenlon, Melissa Johnson, Jessica Jones, Megan Kolb, Sarah Lam, Lucy Miranda, Jackie Ward, Renessa Whitman, Brittany Zingler, William Ryan, Robert L. Smith, Paul Grayburn, Pedro Nosnik, Eugene H. Blackstone, Nader Moazami, Randall C. Starling, Benico Barzilai, Richard A. Grimm, Edward G. Soltesz, Irene Katzan, Brian Strippy, Shoi Smith, Michelle Garcia, Mary Alice bowman, Carrie Geither, Robert Wang, Michael Argenziano, Michael Borger, Hiroo Takayama, Martin B. Leon, Lyn Goldsmith, Allan Schwartz, Nadia Sookraj, Talaya McCright-Gill, Sowmya Sreekanth, Jock N. McCullough, Alexander Iribarne, Joseph P. DeSimone, Anthony W. DiScipio, Henry Stokes, Amanda St. Ivany, Gaylin Petty, Peter K. Smith, John H. Alexander, Carmelo A. Milano, Donald D. Glower, Joel Huber, Joel Morganlander, Joseph P. Mathew, Stacey Welsh, Sarah Casalinova, Victoria Johnson, Kathleen Lane, Derek Smith, Greg Tipton, Mark F. Berry, Judson B. Williams, Brian Englum, Matthew Hartwig, Robert Guyton, Omar Lattouf, Edward Chen, J. David Vega, Jefferson Baer, Duc Nguyen, Michael Halkos, Kim Baio, Tamara Prince, Natascha Cook, Alexis A. Neill, Mario Senechal, François Dagenais, Robert Laforce, Kim O'Connor, Gladys Dussault, Manon Caouette, Hugo Tremblay, Nathalie Gagne, Julie Dumont, Patricia Landry, Benjamin H. Trichon, Oliver A. Binns, Stephen W. Ely, Alan M. Johnson, Todd H. Hansen, John G. Short, Reid D. Taylor, Ralph Mangusan, Tracy Nanney, Holly Aubart, Kristin Cross, Leslie McPeters, Christina Riggsbee, Lucy Rixey, Robert E. Michler, Joseph J. DeRose, Daniel J. Goldstein, Ricardo A. Bello, Cynthia Taub, Daniel Spevack, Kathryn Kirchoff, Rebecca Meli, Juan Garcia, Jon Goldenberg, Lauren Kealy, Denis Bouchard, Jean François Tanguay, Eileen O'Meara, Jonathan Lacharité, Sophie Robichaud, Keith A. Horvath, Philip C. Corcoran, Michael P. Siegenthaler, Mandy Murphy, Margaret Iraola, Ann Greenberg, Greg Kumkumian, Mark Milner, Zurab Nadareishvili, Ayesha Hasan, Asia McDavid, Denise Fadorsen, Terry Yau, Michael Farkouh, Anna Woo, Robert James Cusimano, Tirone David, Christopher Feindel, Nishit Fumakia, Shakira Christie, Asvina Bissonauth, Alexandra Hripko, Zahid Noor, Kristen Mackowick, Stephanie Deasey, Manal Al-Suqi, Julia Collins, Michael A. Acker, Steven Messé, James Kirkpatrick, Mary Lou Mayer, Caitlin McDonald, Holley Fok, Breanna Maffei, Stephen Cresse, Christine Gepty, Michael Bowdish, Vaughn A. Starnes, David Shavalle, Christi Heck, Amy Hackmann, Craig Baker, Fernando Fleischman, Mark Cunningham, Edward Lozano, Michelle Hernandez, Irving L. Kron, Karen Johnston, Ravi K. Ghanta, John M. Dent, John Kern, Leora Yarboro, Michael Ragosta, Brian Annex, Jim Bergin, Sandra Burks, Mike Cosner, China Green, Samantha Loya, Hye Ryun Kim, David A. Bull, Patrice Desvigne-Nickens, Dennis O. Dixon, Rebecca Gottesman, Mark Haigney, Richard Holubkov, Constantino Iadecola, Alice Jacobs, Eric M. Meslin, John M. Murkin, John A. Spertus, Frank Sellke, Cheryl L. McDonald, John Canty, Neal Dickert, John S. Ikonomidis, KyungMann Kim, David O. Williams, Clyde W. Yancy, Seemant Chaturvedi, Marc Chimowitz, James C. Fang, Wayne Richenbacher, Vivek Rao, Rachel Miller, Jennifer Cook, David D'Alessandro, Frederick Han, Sean Pinney, Mary N. Walsh, David Greer, Koto Ishida, Christian Stapf, Judy Hung, Xin Zeng, David Hung, Sudarat Satitthummanid, Michel Billelo, Christos Davatzikos, Lauren Karpf, Lisa Desiderio, Yanne Toulgoat-Dubois, Rachele Brassard, Renu Virmanu, Maria E. Romero, and Ryan Braumann

Subjects
Pulmonary and Respiratory Medicine, Surgery, Cardiology and Cardiovascular Medicine
Abstract

The effects of stroke and delirium on postdischarge cognition and patient-centered health outcomes after surgical aortic valve replacement (SAVR) are not well characterized. Here, we assess the impact of postoperative stroke and delirium on these health outcomes in SAVR patients at 90 days.Patients (N = 383) undergoing SAVR (41% received concomitant coronary artery bypass graft) enrolled in a randomized trial of embolic protection devices underwent serial neurologic and delirium evaluations at postoperative days 1, 3, and 7 and magnetic resonance imaging at day 7. Outcomes included 90-day functional status, neurocognitive decline from presurgical baseline, and quality of life.By postoperative day 7, 25 (6.6%) patients experienced clinical stroke and 103 (28.5%) manifested delirium. During index hospitalization, time to discharge was longer in patients experiencing stroke (hazard ratio, 0.62; 95% confidence interval [CI], 0.42-0.94; P = .02) and patients experiencing delirium (hazard ratio, 0.68; 95% CI, 0.54-0.86; P = .001). At day 90, patients experiencing stroke were more likely to have a modified Rankin score2 (odds ratio [OR], 5.9; 95% CI, 1.7-20.1; P = .01), depression (OR, 5.3; 95% CI, 1.6-17.3; P = .006), a lower 12-Item Short Form Survey physical health score (adjusted mean difference -3.3 ± 1.9; P = .08), and neurocognitive decline (OR, 7.8; 95% CI, 2.3-26.4; P = .001). Delirium was associated with depression (OR, 2.2; 95% CI, 0.9-5.3; P = .08), lower 12-Item Short Form Survey physical health (adjusted mean difference -2.3 ± 1.1; P = .03), and neurocognitive decline (OR, 2.2; 95% CI, 1.2-4.0; P = .01).Stroke and delirium occur more frequently after SAVR than is commonly recognized, and these events are associated with disability, depression, cognitive decline, and poorer quality of life at 90 days postoperatively. These findings support the need for new interventions to reduce these events and improve patient-centered outcomes.

Published
2022

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

Author

Anuradha Lala, Helena L. Chang, Xiaoyu Liu, Eric J. Charles, Babatunde A. Yerokun, Michael E. Bowdish, Vinod H. Thourani, Michael J. Mack, Marissa A. Miller, Patrick T. O'Gara, Eugene H. Blackstone, Alan J. Moskowitz, Annetine C. Gelijns, John C. Mullen, Lynne W. Stevenson, Joseph J. DeRose, Alice Wang, Peter K. Smith, Michael A. Acker, Gorav Ailawadi, Wendy C. Taddei-Peters, Dennis Buxton, Ron Caulder, Nancy L. Geller, David Gordon, Neal O. Jeffries, Albert Lee, Ilana Kogan Gombos, Jennifer Ralph, Richard D. Weisel, Timothy J. Gardner, Eric A. Rose, Michael K. Parides, Deborah D. Ascheim, Emilia Bagiella, Ellen Moquete, Helena Chang, Melissa Chase, James Foo, Yingchun Chen, Seth Goldfarb, Lopa Gupta, Katherine Kirkwood, Edlira Dobrev, Ron Levitan, Karen O'Sullivan, Jessica Overbey, Milerva Santos, Deborah Williams, Michael Weglinski, Paula Williams, Carrie Wood, Xia Ye, Sten Lyager Nielsen, Henrik Wiggers, Henning Malgaard, Michael Mack, Tracine Adame, Natalie Settele, Jenny Adams, William Ryan, Robert L. Smith, Paul Grayburn, Frederick Y. Chen, Anju Nohria, Lawrence Cohn, Prem Shekar, Sary Aranki, Gregory Couper, Michael Davidson, R. Morton Bolman, Anne Burgess, Debra Conboy, Rita Lawrence, Nicolas Noiseux, Louis-Mathieu Stevens, Ignacio Prieto, Fadi Basile, Joannie Dionne, Julie Fecteau, A. Marc Gillinov, Pamela Lackner, Leoma Berroteran, Diana Dolney, Suzanne Fleming, Roberta Palumbo, Christine Whitman, Kathy Sankovic, Denise Kosty Sweeney, Carrie Geither, Kristen Doud, Gregory Pattakos, Pamela A. Clarke, Michael Argenziano, Mathew Williams, Lyn Goldsmith, Craig R. Smith, Yoshifumi Naka, Allan Stewart, Allan Schwartz, Daniel Bell, Danielle Van Patten, Sowmya Sreekanth, John H. Alexander, Carmelo A. Milano, Donald D. Glower, Joseph P. Mathew, J. Kevin Harrison, Stacey Welsh, Mark F. Berry, Cyrus J. Parsa, Betty C. Tong, Judson B. Williams, T. Bruce Ferguson, Alan P. Kypson, Evelio Rodriguez, Malissa Harris, Brenda Akers, Allison O'Neal, John D. Puskas, Robert Guyton, Jefferson Baer, Kim Baio, Alexis A. Neill, Pierre Voisine, Mario Senechal, François Dagenais, Kim O'Connor, Gladys Dussault, Tatiana Ballivian, Suzanne Keilani, Alan M. Speir, Patrick Magee, Niv Ad, Sally Keyte, Minh Dang, Mark Slaughter, Marsha Headlee, Heather Moody, Naresh Solankhi, Emma Birks, Mark A. Groh, Leslie E. Shell, Stephanie A. Shepard, Benjamin H. Trichon, Tracy Nanney, Lynne C. Hampton, Ralph Mangusan, Robert E. Michler, David A. D'Alessandro, Daniel J. Goldstein, Ricardo Bello, William Jakobleff, Mario Garcia, Cynthia Taub, Daniel Spevak, Roger Swayze, Nadia Sookraj, Louis P. Perrault, Arsène-Joseph Basmadjian, Denis Bouchard, Michel Carrier, Raymond Cartier, Michel Pellerin, Jean François Tanguay, Ismail El-Hamamsy, André Denault, Philippe Demers, Sophie Robichaud Jonathan Lacharité, Keith A. Horvath, Philip C. Corcoran, Michael P. Siegenthaler, Mandy Murphy, Margaret Iraola, Ann Greenberg, Chittoor Sai-Sudhakar, Ayseha Hasan, Asia McDavid, Bradley Kinn, Pierre Pagé, Carole Sirois, David Latter, Howard Leong-Poi, Daniel Bonneau, Lee Errett, Mark D. Peterson, Subodh Verma, Randi Feder-Elituv, Gideon Cohen, Campbell Joyner, Stephen E. Fremes, Fuad Moussa, George Christakis, Reena Karkhanis, Terry Yau, Michael Farkouh, Anna Woo, Robert James Cusimano, Tirone David, Christopher Feindel, Lisa Garrard, Suzanne Fredericks, Amelia Mociornita, Jonathan Choy, Steven Meyer, Emily Kuurstra, James S. Gammie, Cindi A. Young, Dana Beach, Robert Villanueva, Pavan Atluri, Y. Joseph Woo, Mary Lou Mayer, Michael Bowdish, Vaughn A. Starnes, David Shavalle, Ray Matthews, Shadi Javadifar, Linda Romar, Irving L. Kron, Karen Johnston, John M. Dent, John Kern, Jessica Keim, Sandra Burks, Kim Gahring, David A. Bull, Dennis O. Dixon, Mark Haigney, Richard Holubkov, Alice Jacobs, Frank Miller, John M. Murkin, John Spertus, Andrew S. Wechsler, Frank Sellke, Robert Byington, Neal Dickert, John S. Ikonomidis, David O. Williams, Clyde W. Yancy, James C. Fang, Nadia Giannetti, Wayne Richenbacher, Vivek Rao, Karen L. Furie, Rachel Miller, Sean Pinney, William C. Roberts, Mary N. Walsh, Judy Hung, Xin Zeng, Niamh Kilcullen, David Hung, Stephen J. Keteyian, Clinton A. Brawner, Heather Aldred, Jeffrey Browndyke, and Yanne Toulgoat-Dubois

Subjects
Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Myocardial Ischemia, 030204 cardiovascular system & hematology, Risk Assessment, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Risk Factors, Mitral valve, Humans, Medicine, Prospective Studies, Adverse effect, Aged, Mitral regurgitation, business.industry, Mitral Valve Insufficiency, Odds ratio, Middle Aged, medicine.disease, Patient Discharge, Confidence interval, 3. Good health, Cardiac surgery, Surgery, Treatment Outcome, medicine.anatomical_structure, 030228 respiratory system, Heart failure, Quality of Life, Female, Cardiology and Cardiovascular Medicine, business
Abstract

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).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.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.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.

Published
2021

7. Cost-Effectiveness of CABG plus Mitral-Valve Repair vs CABG Alone for Moderate Ischemic Mitral Regurgitation

Author

Bart S. Ferket, Vinod H. Thourani, Pierre Voisine, Samuel F. Hohmann, Helena L. Chang, Peter K. Smith, Robert E. Michler, Gorav Ailawadi, Louis P. Perrault, Marissa A. Miller, Karen O'Sullivan, Stephanie L. Mick, Emilia Bagiella, Michael A. Acker, Ellen Moquete, Judy W. Hung, Jessica R. Overbey, Anuradha Lala, Margaret Iraola, James S. Gammie, Annetine C. Gelijns, Patrick T. O'Gara, Alan J. Moskowitz, Wendy C. Taddei-Peters, Dennis Buxton, Ron Caulder, Nancy L. Geller, David Gordon, Neal O. Jeffries, Albert Lee, Claudia S. Moy, Ilana Kogan Gombos, Jennifer Ralph, Richard Weisel, Timothy J. Gardner, Eric A. Rose, Michael K. Parides, Deborah D. Ascheim, Helena Chang, Melissa Chase, Yingchun Chen, Seth Goldfarb, Lopa Gupta, Katherine Kirkwood, Edlira Dobrev, Ron Levitan, Jessica Overbey, Milerva Santos, Michael Weglinski, Paula Williams, Carrie Wood, Xia Ye, Sten Lyager Nielsen, Henrik Wiggers, Henning Malgaard, Michael Mack, Tracine Adame, Natalie Settele, Jenny Adams, William Ryan, Robert L. Smith, Paul Grayburn, Frederick Y. Chen, Anju Nohria, Lawrence Cohn, Prem Shekar, Sary Aranki, Gregory Couper, Michael Davidson, R. Morton Bolman, Anne Burgess, Debra Conboy, Nicolas Noiseux, Louis-Mathieu Stevens, Ignacio Prieto, Fadi Basile, Joannie Dionne, Julie Fecteau, Eugene H. Blackstone, A. Marc Gillinov, Pamela Lackner, Leoma Berroteran, Diana Dolney, Suzanne Fleming, Roberta Palumbo, Christine Whitman, Kathy Sankovic, Denise Kosty Sweeney, Gregory Pattakos, Pamela A. Clarke, Michael Argenziano, Mathew Williams, Lyn Goldsmith, Craig R. Smith, Yoshifumi Naka, Allan Stewart, Allan Schwartz, Daniel Bell, Danielle Van Patten, Sowmya Sreekanth, John H. Alexander, Carmelo A. Milano, Donald D. Glower, Joseph P. Mathew, J. Kevin Harrison, Stacey Welsh, Mark F. Berry, Cyrus J. Parsa, Betty C. Tong, Judson B. Williams, T. Bruce Ferguson, Alan P. Kypson, Evelio Rodriguez, Malissa Harris, Brenda Akers, Allison O'Neal, John D. Puskas, Robert Guyton, Jefferson Baer, Kim Baio, Alexis A. Neill, Mario Senechal, François Dagenais, Kim O'Connor, Gladys Dussault, Tatiana Ballivian, Suzanne Keilani, Alan M. Speir, Patrick Magee, Niv Ad, Sally Keyte, Minh Dang, Mark Slaughter, Marsha Headlee, Heather Moody, Naresh Solankhi, Emma Birks, Mark A. Groh, Leslie E. Shell, Stephanie A. Shepard, Benjamin H. Trichon, Tracy Nanney, Lynne C. Hampton, David A. D'Alessandro, Joseph J. DeRose, Daniel J. Goldstein, Ricardo Bello, William Jakobleff, Mario Garcia, Cynthia Taub, Daniel Spevak, Roger Swayze, Arsène-Joseph Basmadjian, Denis Bouchard, Michel Carrier, Raymond Cartier, Michel Pellerin, Jean François Tanguay, Ismail El-Hamamsy, André Denault, Philippe Demers, Sophie Robichaud, Keith A. Horvath, Philip C. Corcoran, Michael P. Siegenthaler, Mandy Murphy, Ann Greenberg, Chittoor Sai-Sudhakar, Ayseha Hasan, Asia McDavid, Bradley Kinn, Pierre Pagé, Carole Sirois, David Latter, Howard Leong-Poi, Daniel Bonneau, Lee Errett, Mark D. Peterson, Subodh Verma, Randi Feder-Elituv, Gideon Cohen, Campbell Joyner, Stephen E. Fremes, Fuad Moussa, George Christakis, Reena Karkhanis, Terry Yau, Michael Farkouh, Anna Woo, Robert James Cusimano, Tirone David, Christopher Feindel, Lisa Garrard, Suzanne Fredericks, Amelia Mociornita, John C. Mullen, Jonathan Choy, Steven Meyer, Emily Kuurstra, Cindi A. Young, Dana Beach, Pavan Atluri, Y. Joseph Woo, Mary Lou Mayer, Michael Bowdish, Vaughn A. Starnes, David Shavalle, Ray Matthews, Shadi Javadifar, Linda Romar, Irving L. Kron, Karen Johnston, John M. Dent, John Kern, Jessica Keim, Sandra Burks, Kim Gahring, David A. Bull, Patrice Desvigne-Nickens, Dennis O. Dixon, Mark Haigney, Richard Holubkov, Alice Jacobs, Frank Miller, John M. Murkin, John Spertus, Andrew S. Wechsler, Frank Sellke, Cheryl L. McDonald, Robert Byington, Neal Dickert, John S. Ikonomidis, David O. Williams, Clyde W. Yancy, James C. Fang, Nadia Giannetti, Wayne Richenbacher, Vivek Rao, Karen L. Furie, Rachel Miller, Sean Pinney, William C. Roberts, Mary N. Walsh, Stephen J. Keteyian, Clinton A. Brawner, Heather Aldred, Judy Hung, Xin Zeng, Jeffrey Browndyke, and Yanne Toulgoat-Dubois

Subjects
Male, Mitral Valve Annuloplasty, Time Factors, Cost effectiveness, medicine.medical_treatment, Cost-Benefit Analysis, Coronary Artery Disease, 030204 cardiovascular system & hematology, 0302 clinical medicine, Risk Factors, Mitral valve, Multicenter Studies as Topic, Hospital Costs, Coronary Artery Bypass, health care economics and organizations, Randomized Controlled Trials as Topic, Heart Valve Prosthesis Implantation, Mortality rate, Hazard ratio, Mitral Valve Insufficiency, Middle Aged, 3. Good health, Models, Economic, Treatment Outcome, medicine.anatomical_structure, Cardiology, Mitral Valve, Female, Quality-Adjusted Life Years, Cardiology and Cardiovascular Medicine, Incremental cost-effectiveness ratio, Artery, Pulmonary and Respiratory Medicine, Canada, medicine.medical_specialty, Article, 03 medical and health sciences, Internal medicine, medicine, Humans, Computer Simulation, Cardiac Surgical Procedures, Aged, Mitral regurgitation, Mitral valve repair, business.industry, 030228 respiratory system, Quality of Life, Surgery, business
Abstract

Objective The Cardiothoracic Surgical Trials Network reported that left ventricular reverse remodeling at 2 years did not differ between patients with moderate ischemic mitral regurgitation randomized to coronary artery bypass grafting plus mitral valve repair (n = 150) or coronary artery bypass grafting alone (n = 151). To address health resource use implications, we compared costs and quality-adjusted survival. Methods We used individual patient data from the Cardiothoracic Surgical Trials Network trial on survival, hospitalizations, quality of life, and US hospitalization costs to estimate cumulative costs and quality-adjusted life years. A microsimulation model was developed to extrapolate to 10 years. Bootstrap and deterministic sensitivity analyses were performed to address uncertainty. Results In-hospital costs were $59,745 for coronary artery bypass grafting plus mitral valve repair versus $51,326 for coronary artery bypass grafting alone (difference $8419; 95% uncertainty interval, 2259-18,757). Two-year costs were $81,263 versus $67,341 (difference 13,922 [2370 to 28,888]), and quality-adjusted life years were 1.35 versus 1.30 (difference 0.05; −0.04 to 0.14), resulting in an incremental cost-effectiveness ratio of $308,343/quality-adjusted life year for coronary artery bypass grafting plus mitral valve repair. At 10 years, its costs remained higher ($107,733 vs $88,583, difference 19,150 [−3866 to 56,826]) and quality-adjusted life years showed no difference (−0.92 to 0.87), with 5.08 versus 5.08. The likelihood that coronary artery bypass grafting plus mitral valve repair would be considered cost-effective at 10 years based on a cost-effectiveness threshold of $100K/quality-adjusted life year did not exceed 37%. Only when this procedure reduces the death rate by a relative 5% will the incremental cost-effectiveness ratio fall below $100K/quality-adjusted life year. Conclusions: The addition of mitral valve repair to coronary artery bypass grafting for patients with moderate ischemic mitral regurgitation is unlikely to be cost-effective. Only if late mortality benefits can be demonstrated will it meet commonly used cost-effectiveness criteria.

Published
2019

8. Pacemaker Implantation After Mitral Valve Surgery With Atrial Fibrillation Ablation

Author

Joseph J. DeRose, Donna M. Mancini, Helena L. Chang, Michael Argenziano, François Dagenais, Gorav Ailawadi, Louis P. Perrault, Michael K. Parides, Wendy C. Taddei-Peters, Michael J. Mack, Donald D. Glower, Babatunde A. Yerokun, Pavan Atluri, John C. Mullen, John D. Puskas, Karen O’Sullivan, Nancy M. Sledz, Hugo Tremblay, Ellen Moquete, Bart S. Ferket, Alan J. Moskowitz, Alexander Iribarne, Annetine C. Gelijns, Patrick T. O’Gara, Eugene H. Blackstone, A. Marc Gillinov, Marissa A. Miller, Dennis Buxton, Amy Connolly, Nancy L. Geller, David Gordon, Neal O. Jeffries, Albert Lee, Claudia S. Moy, Ilana Kogan Gombos, Jennifer Ralph, Richard Weisel, Timothy J. Gardner, Eric A. Rose, Deborah D. Ascheim, Emilia Bagiella, Helena Chang, Melissa Chase, Edlira Dobrev, Seth Goldfarb, Lopa Gupta, Katherine Kirkwood, Ron Levitan, Jessica Overbey, Milerva Santos, Michael Weglinski, Paula Williams, Carrie Wood, Xia Ye, Michael Mack, Tracine Adame, Natalie Settele, Jenny Adams, William Ryan, Robert L. Smith, Paul Grayburn, Frederick Y. Chen, Anju Nohria, Lawrence Cohn, Prem Shekar, Sary Aranki, Gregory Couper, Michael Davidson, R. Morton Bolman, Anne Burgess, Debra Conboy, Ray Blackwell, Roger Kerzner, Michael Banbury, Andrea M. Squire, Bruce Lytle, Tomislav Mihaljevic, Pamela Lackner, Leoma Berroteran, Diana Dolney, Suzanne Fleming, Roberta Palumbo, Christine Whitman, Kathy Sankovic, Denise Kosty Sweeney, Gregory Pattakos, Mathew Williams, Lyn Goldsmith, Craig R. Smith, Yoshifumi Naka, Allan Stewart, Allan Schwartz, Daniel Bell, Danielle Van Patten, Sowmya Sreekanth, Peter K. Smith, John H. Alexander, Carmelo A. Milano, Joseph P. Mathew, J. Kevin Harrison, Stacey Welsh, T. Bruce Ferguson, Alan P. Kypson, Evelio Rodriguez, Malissa Harris, Brenda Akers, Allison O'Neal, Vinod H. Thourani, Robert Guyton, Jefferson Baer, Kim Baio, Alexis A. Neill, Pierre Voisine, Mario Senechal, Kim O’Connor, Gladys Dussault, Tatiana Ballivian, Suzanne Keilani, Robert E. Michler, David A. D'Alessandro, Daniel J. Goldstein, Ricardo Bello, William Jakobleff, Mario Garcia, Cynthia Taub, Daniel Spevack, Roger Swayze, Nadia Sookraj, Arsène-Joseph Basmadjian, Denis Bouchard, Michel Carrier, Raymond Cartier, Michel Pellerin, Jean François Tanguay, Ismael El-Hamamsy, André Denault, Jonathan Lacharité, Sophie Robichaud, David H. Adams, Robin Varghese, Yael Mandel-Portnoy, Keith A. Horvath, Philip C. Corcoran, Michael P. Siegenthaler, Mandy Murphy, Margaret Iraola, Ann Greenberg, Chittoor Sai-Sudhakar, Ayseha Hasan, Asia McDavid, Bradley Kinn, Jonathan Choy, Steven Meyer, Emily Kuurstra, James S. Gammie, Christopher R. DeFilippi, Dino T. Gaetani, Cindi A. Young, Dana Beach, Julia Collins, Steven F. Bolling, Francis D. Pagani, Cathie Bloem, Michael A. Acker, Y. Joseph Woo, Mary Lou Mayer, Joseph E. Bavaria, Wilson Y. Szeto, Kenneth Margulies, Martin Keane, Helene Glassberg, Dinesh Jagasia, James Kirkpatrick, Irving L. Kron, Karen Johnston, John M. Dent, John Kern, Jessica Keim, Sandra Burks, Kim Gahring, Abeel Mangi, Joseph Akar, David Yuh, Lynn Wilson, David A. Bull, Patrice Desvigne-Nickens, Dennis O. Dixon, Mark Haigney, Richard Holubkov, Alice Jacobs, Frank Miller, John M. Murkin, John Spertus, Andrew S. Wechsler, Frank Sellke, Cheryl L. McDonald, Robert Byington, Neal Dickert, John S. Ikonomidis, David O. Williams, Clyde W. Yancy, John M. Canty, James C. Fang, Nadia Giannetti, Wayne Richenbacher, Vivek Rao, Karen L. Furie, Rachel Miller, Sean Pinney, William C. Roberts, Mary N. Walsh, Judy Hung, Xin Zeng, Jean-Philippe Couderc, Dan Balda, Wayne Bowen, Mauri Wilson, and Anne Schering

Subjects
Male, medicine.medical_specialty, Randomization, medicine.medical_treatment, Heart Valve Diseases, 030204 cardiovascular system & hematology, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Risk Factors, Internal medicine, Atrial Fibrillation, medicine, Humans, 030212 general & internal medicine, Heart Atria, Cardiac Surgical Procedures, Aged, business.industry, valvular heart disease, Hazard ratio, Cardiac Pacing, Artificial, Atrial fibrillation, Middle Aged, medicine.disease, Ablation, Confidence interval, Cardiac surgery, Pulmonary Veins, Cardiology, Catheter Ablation, Mitral Valve, Female, Cardiology and Cardiovascular Medicine, business
Abstract

Background The incidence of permanent pacemaker (PPM) implantation is higher following mitral valve surgery (MVS) with ablation for atrial fibrillation (AF) compared with MVS alone. Objectives This study identified risk factors and outcomes associated with PPM implantation in a randomized trial that evaluated ablation for AF in patients who underwent MVS. Methods A total of 243 patients with AF and without previous PPM placement were randomly assigned to MVS alone (n = 117) or MVS + ablation (n = 126). Patients in the ablation group were further randomized to pulmonary vein isolation (PVI) (n = 62) or the biatrial maze procedure (n = 64). Using competing risk models, this study examined the association among PPM and baseline and operative risk factors, and the effect of PPM on time to discharge, readmissions, and 1-year mortality. Results Thirty-five patients received a PPM within the first year (14.4%), 29 (83%) underwent implantation during the index hospitalization. The frequency of PPM implantation was 7.7% in patients randomized to MVS alone, 16.1% in MVS + PVI, and 25% in MVS + biatrial maze. The indications for PPM were similar among patients who underwent MVS with and without ablation. Ablation, multivalve surgery, and New York Heart Association functional (NYHA) functional class III/IV were independent risk factors for PPM implantation. Length of stay post-surgery was longer in patients who received PPMs, but it was not significant when adjusted for randomization assignment (MVS vs. ablation) and age (hazard ratio [HR]: 0.81; 95% confidence interval [CI]: 0.61 to 1.08; p = 0.14). PPM implantation did not increase 30-day readmission rate (HR: 1.43; 95% CI: 0.50 to 4.05; p = 0.50). The need for PPM was associated with a higher risk of 1-year mortality (HR: 3.21; 95% CI: 1.01 to 10.17; p = 0.05) after adjustment for randomization assignment, age, and NYHA functional class. Conclusions AF ablation, multivalve surgery, and NYHA functional class III/IV were associated with an increased risk for permanent pacing. PPM implantation following MVS was associated with a significant increase in 1-year mortality. (Surgical Ablation Versus No Surgical Ablation for Patients With Atrial Fibrillation Undergoing Mitral Valve Surgery; NCT00903370)

Published
2019

9. 43017 Learning about Adaptive Capacity and Preparedness of CTSA Hubs

Author

Cathleen Kane, Joe Hunt, Raj C. Shah, Jamie Doyle, Wayne T. McCormack, Miriam A. Bredella, Bart Ragon, Veronica Hoyo, Gaurav Dave, Tanha Patel, Laura Viera, Chris Pulley, Anita Walden, Keith Herzog, Sandra Burks, Boris Volkov, Kristi Holmes, and Anne Seymour

Subjects
Adaptive capacity, Process management, Computer science, Preparedness, General Medicine
Abstract

IMPACT: This work will inform the ongoing development of adaptive capacity and preparedness of the CTSA Program and other clinical and translational research organizations in their quest of improving processes that drive outcomes and impacts, shaping effective programs and services, and strengthening their emergency readiness and sustainability. OBJECTIVES/GOALS: -Share the progress and preliminary findings of an ‘Adaptive Capacity and Preparedness of CTSA Hubs’ CTSA Working Group; -Improve our awareness and understanding of the efficient and effective changes helping CTSA hubs build robust capacity to address METHODS/STUDY POPULATION: A multi-case study including: - Triangulating multiple sources of information and mixed methods (survey/interviews of research administrators, researchers, evaluators, and other key stakeholders), literature review, document and M&E system information analysis, and expert review; - Describing CTSA hubs’ experiences as related to research implementation, translation, and support during the time of emergency; - Administering a comprehensive survey of the CTSAs addressing their challenges, lessons learned, and practices that work in various program components/areas. Data collection includes aggregate and cross-sectional data, with representation based on CTSA size, maturity, and population density. RESULTS/ANTICIPATED RESULTS: The described approach shows sound promise to investigate and share strategies and best practices for building adaptive capacity and preparedness of CTSAs -- across various scientific sectors, translational research spectrum, and the goals outlined by NCATS for the CTSA program. The anticipated results of this research will include the identified/shared innovative solutions and lessons learned for this rapidly emerging, high-priority clinical and translational science issue. ‘High-quality lessons learned’ are those that represent principles extrapolated from multiple sources and triangulated to increase transferability to new contexts and situations. DISCUSSION/SIGNIFICANCE OF FINDINGS: The project provides useful knowledge and tools to research organizations and stakeholders across multiple disciplines -- for mitigating the impact of the COVID-19 disaster via effective adjusting programs, practices, and processes, and building capacity for future successful, ‘emergency ready and responsive’ research and training.

Published
2021

10. Secondary Surgical Site Infection after Coronary Artery Bypass Grafting: A Multi-Institutional Prospective Cohort Study

Author

Brian C. Gulack, Katherine A. Kirkwood, Wei Shi, Peter K. Smith, John H. Alexander, Sandra G. Burks, Annetine C. Gelijns, Vinod H. Thourani, Daniel Bell, Ann Greenberg, Seth D. Goldfarb, Mary Lou Mayer, Michael E. Bowdish, Marissa A. Miller, Wendy C. Taddei-Peters, Dennis Buxton, Ron Caulder, Nancy L. Geller, David Gordon, Neal O. Jeffries, Albert Lee, Claudia S. Moy, Ilana Kogan Gombos, Jennifer Ralph, Timothy J. Gardner, Patrick T. O'Gara, Michael K. Parides, Deborah D. Ascheim, Alan J. Moskowitz, Ellen Moquete, Eric A. Rose, Melissa Chase, Yingchun Chen, Rosemarie Gagliardi, Lopa Gupta, Edlira Kumbarce, Ron Levitan, Karen O'Sullivan, Milerva Santos, Alan Weinberg, Paula Williams, Carrie Wood, Xia Ye, Eugene H. Blackstone, A. Marc Gillinov, Pamela Lackner, Leoma Berroteran, Diana Dolney, Suzanne Fleming, Roberta Palumbo, Christine Whitman, Kathy Sankovic, Denise Kosty Sweeney, Gregory Pattakos, Pamela A. Clarke, Michael Argenziano, Mathew Williams, Lyn Goldsmith, Craig R. Smith, Yoshifumi Naka, Allan Stewart, Allan Schwartz, Danielle Van Patten, Stacey Welsh, Carmelo A. Milano, Donald D. Glower, Joseph P. Mathew, J. Kevin Harrison, Mark F. Berry, Cyrus J. Parsa, Betty C. Tong, Judson B. Williams, T. Bruce Ferguson, Alan P. Kypson, Evelio Rodriguez, Malissa Harris, Brenda Akers, Allison O'Neal, John D. Puskas, Robert Guyton, Jefferson Baer, Kim Baio, Alexis A. Neill, Robert E. Michler, David A. D'Alessandro, Joseph J. DeRose, Daniel J. Goldstein, Ricardo Bello, William Jakobleff, Mario Garcia, Cynthia Taub, Daniel Spevak, Roger Swayze, Louis P. Perrault, Arsène-Joseph Basmadjian, Denis Bouchard, Michel Carrier, Raymond Cartier, Michel Pellerin, Jean François Tanguay, Ismael El-Hamamsy, André Denault, Jonathan Lacharité, Sophie Robichaud, Keith A. Horvath, Philip C. Corcoran, Michael P. Siegenthaler, Mandy Murphy, Margaret Iraola, Michael A. Acker, Y. Joseph Woo, Irving L. Kron, Gorav Ailawadi, Karen Johnston, John M. Dent, John Kern, Jessica Keim Sandra Burks, Kim Gahring, David A. Bull, Patrice Desvigne-Nickens, Dennis O. Dixon, Mark Haigney, Richard Holubkov, Alice Jacobs, Frank Miller, John M. Murkin, John Spertus, Andrew S. Wechsler, Frank Sellke, Cheryl L. McDonald, Robert Byington, Neal Dickert, John S. Ikonomidis, David O. Williams, Clyde W. Yancy, James C. Fang, Wayne Richenbacher, Vivek Rao, Karen L. Furie, Rachel Miller, Sean Pinney, William C. Roberts, Shirish Huprikar, and Marilyn Levi

Subjects
Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Time Factors, 030204 cardiovascular system & hematology, Patient Readmission, Risk Assessment, Article, Body Mass Index, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Interquartile range, medicine, Humans, Surgical Wound Infection, Saphenous Vein, Prospective Studies, 030212 general & internal medicine, Coronary Artery Bypass, Prospective cohort study, Aged, Groin, business.industry, Incidence, Hazard ratio, Length of Stay, Middle Aged, United States, Confidence interval, Anti-Bacterial Agents, Surgery, Treatment Outcome, Editorial, surgical procedures, operative, medicine.anatomical_structure, Tissue and Organ Harvesting, Female, Erythrocyte Transfusion, Cardiology and Cardiovascular Medicine, business, Complication, Body mass index, Artery
Abstract

OBJECTIVE: To analyze patient risk factors and processes of care associated with secondary surgical site infection (SSI) after coronary artery bypass grafting (CABG). METHODS: Data were collected prospectively between February and October 2010 for consenting adult patients undergoing CABG with saphenous vein graft (SVG) conduits. Patients who developed a deep or superficial SSI of the leg or groin within 65 days of CABG were compared to those who did not develop a secondary SSI. RESULTS: Among 2,174 patients identified, 65 (3.0%) developed a secondary SSI. Median time to diagnosis was 16 days (interquartile range [IQR]: 11 - 29) with the majority (86%) diagnosed after discharge. Gram-positive bacteria were most common. Readmission was more common in patients with a secondary SSI (34% vs 17%, p < 0.01). After adjustment, an open SVG harvest approach was associated with an increased risk of secondary SSI (adjusted hazard ratio [HR]: 2.12, 95% confidence interval [CI]: 1.28, 3.48). Increased body mass index (BMI) (adjusted HR: 1.08, 95% CI: 1.04, 1.12) and packed red blood cell (PRBC) transfusions (adjusted HR: 1.13, 95% CI: 1.05, 1.22) were associated with a higher risk of secondary SSI. Antibiotic type, antibiotic duration, and post-operative hyperglycemia were not associated with risk of secondary SSI. CONCLUSIONS: Secondary SSI following CABG continues to be an important source of morbidity. This serious complication often occurs after discharge and is associated with open SVG harvesting, larger BMI, and blood transfusions. Patients with a secondary SSI have longer lengths of stay and are readmitted more frequently.

Published
2017

11. Biatrial maze procedure versus pulmonary vein isolation for atrial fibrillation during mitral valve surgery: New analytical approaches and end points

Author

Eugene H. Blackstone, Helena L. Chang, Jeevanantham Rajeswaran, Michael K. Parides, Hemant Ishwaran, Liang Li, John Ehrlinger, Annetine C. Gelijns, Alan J. Moskowitz, Michael Argenziano, Joseph J. DeRose, Jean-Phillipe Couderc, Dan Balda, François Dagenais, Michael J. Mack, Gorav Ailawadi, Peter K. Smith, Michael A. Acker, Patrick T. O'Gara, A. Marc Gillinov, Marissa A. Miller, Wendy C. Taddei-Peters, Dennis Buxton, Amy Connolly, Nancy L. Geller, David Gordon, Neal O. Jeffries, Albert Lee, Claudia S. Moy, Ilana Kogan Gombos, Jennifer Ralph, Richard Weisel, Timothy J. Gardner, Eric A. Rose, Deborah D. Ascheim, Emilia Bagiella, Ellen Moquete, Helena Chang, Melissa Chase, Seth Goldfarb, Lopa Gupta, Katherine Kirkwood, Edlira Kumbarce, Ron Levitan, Karen O'Sullivan, Jessica Overbey, Milerva Santos, Michael Weglinski, Paula Williams, Carrie Wood, Xia Ye, Michael Mack, Tracine Adame, Natalie Settele, Jenny Adams, William Ryan, Robert L. Smith, Paul Grayburn, Frederick Y. Chen, Anju Nohria, Lawrence Cohn, Prem Shekar, Sary Aranki, Gregory Couper, Michael Davidson, R. Morton Bolman, Anne Burgess, Debra Conboy, Ray Blackwell, Roger Kerzner, Michael Banbury, Andrea M. Squire, Bruce Lytle, Tomislav Mihaljevic, Pamela Lackner, Leoma Berroteran, Diana Dolney, Suzanne Fleming, Roberta Palumbo, Christine Whitman, Kathy Sankovic, Denise Kosty Sweeney, Gregory Pattakos, Mathew Williams, Lyn Goldsmith, Craig R. Smith, Yoshifumi Naka, Allan Stewart, Allan Schwartz, Daniel Bell, Danielle Van Patten, Sowmya Sreekanth, John H. Alexander, Carmelo A. Milano, Donald D. Glower, Joseph P. Mathew, J. Kevin Harrison, Stacey Welsh, T. Bruce Ferguson, Alan P. Kypson, Evelio Rodriguez, Malissa Harris, Brenda Akers, Allison O'Neal, John D. Puskas, Vinod H. Thourani, Robert Guyton, Jefferson Baer, Kim Baio, Alexis A. Neill, Pierre Voisine, Mario Senechal, Kim O'Connor, Gladys Dussault, Tatiana Ballivian, Suzanne Keilani, Robert E. Michler, David A. D'Alessandro, Daniel J. Goldstein, Ricardo Bello, William Jakobleff, Mario Garcia, Cynthia Taub, Daniel Spevack, Roger Swayze, Nadia Sookraj, Louis P. Perrault, Arsène-Joseph Basmadjian, Denis Bouchard, Michel Carrier, Raymond Cartier, Michel Pellerin, Jean François Tanguay, Ismael El-Hamamsy, André Denault, Jonathan Lacharité, Sophie Robichaud, David H. Adams, Robin Varghese, Yael Mandel-Portnoy, Keith A. Horvath, Philip C. Corcoran, Michael P. Siegenthaler, Mandy Murphy, Margaret Iraola, Ann Greenberg, Chittoor Sai-Sudhakar, Ayseha Hasan, Asia McDavid, Bradley Kinn, John C. Mullen, Jonathan Choy, Steven Meyer, Emily Kuurstra, James S. Gammie, Christopher R. DeFilippi, Dino T. Gaetani, Cindi A. Young, Dana Beach, Julia Collins, Steven F. Bolling, Francis D. Pagani, Cathie Bloem, Y. Joseph Woo, Mary Lou Mayer, Joseph E. Bavaria, Wilson Y. Szeto, Kenneth Margulies, Martin Keane, Helene Glassberg, Dinesh Jagasia, James Kirkpatrick, Irving L. Kron, Karen Johnston, John M. Dent, John Kern, Jessica Keim, Sandra Burks, Kim Gahring, Abeel Mangi, Joseph Akar, David Yuh, Lynn Wilson, David A. Bull, Patrice Desvigne-Nickens, Dennis O. Dixon, Mark Haigney, Richard Holubkov, Alice Jacobs, Frank Miller, John M. Murkin, John Spertus, Andrew S. Wechsler, Frank Sellke, Cheryl L. McDonald, Robert Byington, Neal Dickert, John S. Ikonomidis, David O. Williams, Clyde W. Yancy, John M. Canty, James C. Fang, Nadia Giannetti, Wayne Richenbacher, Vivek Rao, Karen L. Furie, Rachel Miller, Sean Pinney, William C. Roberts, Mary N. Walsh, Judy Hung, Xin Zeng, Jean-Philippe Couderc, Wayne Bowen, Mauri Wilson, and Anne Schering

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, business.industry, medicine.medical_treatment, Atrial fibrillation, Odds ratio, 030204 cardiovascular system & hematology, Ablation, medicine.disease, Confidence interval, 3. Good health, Confirmatory trial, Pulmonary vein, 03 medical and health sciences, 0302 clinical medicine, 030228 respiratory system, Internal medicine, medicine, Cardiology, Surgery, medicine.symptom, Cardiology and Cardiovascular Medicine, business, Atrial tachycardia, Atrial flutter
Abstract

Objective To use novel statistical methods for analyzing the effect of lesion set on (long-standing) persistent atrial fibrillation (AF) in the Cardiothoracic Surgical Trials Network trial of surgical ablation during mitral valve surgery (MVS). Methods Two hundred sixty such patients were randomized to MVS + surgical ablation or MVS alone. Ablation was randomized between pulmonary vein isolation and biatrial maze. During 12 months postsurgery, 228 patients (88%) submitted 7949 transtelephonic monitoring (TTM) recordings, analyzed for AF, atrial flutter (AFL), or atrial tachycardia (AT). As previously reported, more ablation than MVS-alone patients were free of AF or AF/AFL at 6 and 12 months (63% vs 29%; P Results Estimated freedom from AF/AFL/AT on any transmission trended higher after biatrial maze than pulmonary vein isolation (odds ratio, 2.31; 95% confidence interval, 0.95-5.65; P = .07) 3 to 12 months postsurgery; estimated AF/AFL/AT load (ie, proportion of TTM strips recording AF/AFL/AT) was similar (odds ratio, 0.90; 95% confidence interval, 0.57-1.43; P = .6). Within 12 months, estimated prevalence of AF/AFL/AT by TTM was 58% after MVS alone, and 36% versus 23% after pulmonary vein isolation versus biatrial maze (P Conclusions Statistical modeling using TTM recordings after MVS in patients with (long-standing) persistent AF suggests that a biatrial maze is associated with lower AF/AFL/AT prevalence, but not a lower load, compared with pulmonary vein isolation. The discrepancy between AF/AFL/AT prevalence assessed at 2 time points by Holter monitoring versus weekly TTM suggests the need for a confirmatory trial, reassessment of definitions for failure after ablation, and validation of statistical methods for assessing atrial rhythms longitudinally.

Published
2019

12. Secondary surgical-site infection after coronary artery bypass grafting: A multi-institutional prospective cohort study

Author

Gulack, Brian C., primary, Kirkwood, Katherine A., additional, Shi, Wei, additional, Smith, Peter K., additional, Alexander, John H., additional, Burks, Sandra G., additional, Gelijns, Annetine C., additional, Thourani, Vinod H., additional, Bell, Daniel, additional, Greenberg, Ann, additional, Goldfarb, Seth D., additional, Mayer, Mary Lou, additional, Bowdish, Michael E., additional, Miller, Marissa A., additional, Taddei-Peters, Wendy C., additional, Buxton, Dennis, additional, Caulder, Ron, additional, Geller, Nancy L., additional, Gordon, David, additional, Jeffries, Neal O., additional, Lee, Albert, additional, Moy, Claudia S., additional, Gombos, Ilana Kogan, additional, Ralph, Jennifer, additional, Gardner, Timothy J., additional, O'Gara, Patrick T., additional, Parides, Michael K., additional, Ascheim, Deborah D., additional, Moskowitz, Alan J., additional, Moquete, Ellen, additional, Rose, Eric A., additional, Chase, Melissa, additional, Chen, Yingchun, additional, Gagliardi, Rosemarie, additional, Gupta, Lopa, additional, Kumbarce, Edlira, additional, Levitan, Ron, additional, O'Sullivan, Karen, additional, Santos, Milerva, additional, Weinberg, Alan, additional, Williams, Paula, additional, Wood, Carrie, additional, Ye, Xia, additional, Blackstone, Eugene H., additional, Gillinov, A. Marc, additional, Lackner, Pamela, additional, Berroteran, Leoma, additional, Dolney, Diana, additional, Fleming, Suzanne, additional, Palumbo, Roberta, additional, Whitman, Christine, additional, Sankovic, Kathy, additional, Sweeney, Denise Kosty, additional, Pattakos, Gregory, additional, Clarke, Pamela A., additional, Argenziano, Michael, additional, Williams, Mathew, additional, Goldsmith, Lyn, additional, Smith, Craig R., additional, Naka, Yoshifumi, additional, Stewart, Allan, additional, Schwartz, Allan, additional, Van Patten, Danielle, additional, Welsh, Stacey, additional, Milano, Carmelo A., additional, Glower, Donald D., additional, Mathew, Joseph P., additional, Harrison, J. Kevin, additional, Berry, Mark F., additional, Parsa, Cyrus J., additional, Tong, Betty C., additional, Williams, Judson B., additional, Ferguson, T. Bruce, additional, Kypson, Alan P., additional, Rodriguez, Evelio, additional, Harris, Malissa, additional, Akers, Brenda, additional, O'Neal, Allison, additional, Puskas, John D., additional, Guyton, Robert, additional, Baer, Jefferson, additional, Baio, Kim, additional, Neill, Alexis A., additional, Michler, Robert E., additional, D'Alessandro, David A., additional, DeRose, Joseph J., additional, Goldstein, Daniel J., additional, Bello, Ricardo, additional, Jakobleff, William, additional, Garcia, Mario, additional, Taub, Cynthia, additional, Spevak, Daniel, additional, Swayze, Roger, additional, Perrault, Louis P., additional, Basmadjian, Arsène-Joseph, additional, Bouchard, Denis, additional, Carrier, Michel, additional, Cartier, Raymond, additional, Pellerin, Michel, additional, Tanguay, Jean François, additional, El-Hamamsy, Ismael, additional, Denault, André, additional, Lacharité, Jonathan, additional, Robichaud, Sophie, additional, Horvath, Keith A., additional, Corcoran, Philip C., additional, Siegenthaler, Michael P., additional, Murphy, Mandy, additional, Iraola, Margaret, additional, Acker, Michael A., additional, Woo, Y. Joseph, additional, Kron, Irving L., additional, Ailawadi, Gorav, additional, Johnston, Karen, additional, Dent, John M., additional, Kern, John, additional, Sandra Burks, Jessica Keim, additional, Gahring, Kim, additional, Bull, David A., additional, Desvigne-Nickens, Patrice, additional, Dixon, Dennis O., additional, Haigney, Mark, additional, Holubkov, Richard, additional, Jacobs, Alice, additional, Miller, Frank, additional, Murkin, John M., additional, Spertus, John, additional, Wechsler, Andrew S., additional, Sellke, Frank, additional, McDonald, Cheryl L., additional, Byington, Robert, additional, Dickert, Neal, additional, Ikonomidis, John S., additional, Williams, David O., additional, Yancy, Clyde W., additional, Fang, James C., additional, Richenbacher, Wayne, additional, Rao, Vivek, additional, Furie, Karen L., additional, Miller, Rachel, additional, Pinney, Sean, additional, Roberts, William C., additional, Huprikar, Shirish, additional, and Levi, Marilyn, additional

Published
2018
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13. Fibrin Sealant Facilitates Hemostasis in Arteriovenous Polytetrafluoroethylene Grafts for Renal Dialysis Access

Author

Worthington G. Schenk, Charles A. Goldthwaite, Sandra Burks, and William D. Spotnitz

Subjects
General Medicine
Abstract

A prospective randomized study was performed to evaluate the efficacy of fibrin sealant (FS) in patients undergoing upper-extremity polytetrafluoroethylene (PTFE) graft placement for dialysis. This procedure appears to be a reproducible and clinically relevant model for evaluating FS in vascular surgery. Consenting adult patients (n = 28) undergoing placement of a PTFE graft (6 mm) were randomized to either the treatment group using FS (Hemaseel APR, Haemacure Corp., Sarasota, FL) or control comparator groups (four) of bovine thrombin (T) (Thrombogen, GenTrac Inc., Middleton, WI), pressure (P), bovine thrombin (Thrombogen, GenTrac Inc.) -soaked cellulose sponges (TG) (Gelfoam, Upjohn Co., Kalamazoo, MI), or oxidized regenerated cellulose (S) (Surgicel, Johnson & Johnson, New Brunswick, NJ). All patients received heparin (3000 IU intravenous push) before placement of vascular clamps. The mean time to hemostasis was 29.3 seconds for FS, 147.4 seconds for T, 872.2 seconds for P, 346 seconds for TG, and 1044.5 seconds for S. There were no significant adverse events. FS appeared to be a superior hemostatic agent in these vascular procedures. No complications from FS were noted.

Published
2002

14. Hemostats, sealants, and adhesives III: a new update as well as cost and regulatory considerations for components of the surgical toolbox

Author

William D, Spotnitz and Sandra, Burks

Subjects
Infection Control, Thrombin, Fibrinogen, Gelatin Sponge, Absorbable, Hemostatics, Polyethylene Glycols, Inventions, Cost Savings, Glutaral, Costs and Cost Analysis, Animals, Equipment Contamination, Humans, Tissue Adhesives, Collagen, Cyanoacrylates, Drug Contamination, Drug Approval, Forecasting
Abstract

The hemostat, sealant, and adhesive components of the surgical toolbox continue to evolve and enter clinical practice at a rapid rate. The goal of this comprehensive, sequential review is to update these components to include those now available (February 2012) as well as to explore cost and regulatory factors that impact the development and use of these materials. A unique system of definitions for organizing these components based on group, category, and class is used as a means of improving the understanding and appropriate use of these materials. The system will be used here to present the most recent additions to the toolbox, which are evaluated based on safety, efficacy, usability, and cost. These new additions include pooled human plasma fibrinogen and thrombin embedded in an equine collagen patch for cardiac surgical hemostasis, polyethylene glycol (PEG) and human serum albumin for lung surgical pneumostasis, modified PEG and trilysine amine for spinal sealing, octyl and butyl lactoyl cyanoacrylate for vascular sealing, and a variety of octyl and butyl cyanoacrylates with or without dyes and/or polyester mesh for skin closure with the creation of a bacterial barrier. The system of definitions will also be used to clarify key strategies in the current health care environment for reducing costs and for increasing understanding of Food and Drug Administration regulatory decisions for these materials.

Published
2012

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