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1. Quality of life after pharmacomechanical catheter-directed thrombolysis for proximal deep vein thrombosis

Author

Susan R. Kahn, Jim A. Julian, Clive Kearon, Chu-Shu Gu, David J. Cohen, Elizabeth A. Magnuson, Anthony J. Comerota, Samuel Z. Goldhaber, Michael R. Jaff, Mahmood K. Razavi, Andrei L. Kindzelski, Joseph R. Schneider, Paul Kim, Rabih Chaer, Akhilesh K. Sista, Robert B. McLafferty, John A. Kaufman, Brandt C. Wible, Morey Blinder, Suresh Vedantham, Michael Sichlau, Athanasios Vlahos, Steven Smith, Quinn Thalheimer, Nisha Singh, Rekha Harting, John Gocke, Scott Guth, Neel Shah, Paul Brady, Marvin Schatz, Mindy Horrow, Peyman Markazi, Leli Forouzan, Terence A.S. Matalon, David Hertzog, Swapna Goday, Margaret Kennedy, Robert Kaplan, Thomas Campbell, Jamie Hartman, Elmer Nahum, Arvind Venkat, Venkataramu Krishnamurthy, John Rectenwald, Peter Henke, Jonathan Eliason, Jonathon Willatt, Guillermo Escobar, Shaun Samuels, Barry Katzen, James Benenati, Alex Powell, Constantino Pena, Howard Wallach, Ripal Gandhi, Joseph Schneider, Stanley Kim, Farrah Hashemi, Joseph Boyle, Nilesh Patel, Michael Verta, Daniel Leung, Marc Garcia, Phillip Blatt, Jamil Khatri, Dave Epstein, Randall Ryan, Tom Sweeny, Michael Stillabower, George Kimbiris, Tuhina Raman, Paul Sierzenski, Lelia Getto, Michael Dignazio, Mark Horvath, Heather Gornik, John Bartholomew, Mehdi Shishehbor, Frank Peacock, Douglas Joseph, Soo Hyum Kim, Natalia Fendrikova Mahlay, Daniel Clair, Sean Lyden, Baljendra Kapoor, Gordon McLennon, Gregory Pierce, James Newman, James Spain, Amanjiit Gill, Aaron Hamilton, Anthony Rizzo, Woosup Park, Alan Dietzek, Ira Galin, Dahlia Plummer, Richard Hsu, Patrick Broderick, Andrew Keller, Sameer Sayeed, Dennis Slater, Herb Lustberg, Jan Akus, Robert Sidman, Mandeep Dhami, Phillip Kohanski, Anca Bulgaru, Renuka Dulala, James Burch, Dinesh Kapur, Jie Yang, Mark Ranson, Alan Wladis, David Varnagy, Tarek Mekhail, Robert Winter, Manuel Perez-Izquierdo, Stephen Motew, Robin Royd-Kranis, Raymond Workman, Scott Kribbs, Gerald Hogsette, Phillip Moore, Bradley Thomason, William Means, Richard Bonsall, John Stewart, Daniel Golwya, Ezana Azene, Wayne Bottner, William Bishop, Dave Clayton, Lincoln Gundersen, Jody Riherd, Irina Shakhnovich, Kurt Ziegelbein, Thomas Chang, Karun Sharma, Sandra Allison, Fil Banovac, Emil Cohen, Brendan Furlong, Craig Kessler, Mike McCullough, Jim Spies, Judith Lin, Scott Kaatz, Todd Getzen, Joseph Miller, Scott Schwartz, Loay Kabbani, David McVinnie, John Rundback, Joseph Manno, Richard Schwab, Randolph Cole, Kevin Herman, David Singh, Ravit Barkama, Amish Patel, Anthony Comerota, John Pigott, Andrew Seiwert, Ralph Whalen, Todd Russell, Zakaria Assi, Sahira Kazanjian, Jonathan Yobbagy, Brian Kaminski, Allan Kaufman, Garett Begeman, Robert DiSalle, Subash Thakur, Marc Jacquet, Thomas Dykes, Joseph Gerding, Christopher Baker, Mark Debiasto, Derek Mittleider, George Higgins, Steven Amberson, Roger Pezzuti, Thomas Gallagher, Robert Schainfeld, Stephan Wicky, Sanjeeva Kalva, Gregory Walker, Gloria Salazar, Benjamin Pomerantz, Virenda Patel, Christopher Kabrhel, Shams Iqbal, Suvranu Gangull, Rahmi Oklu, Scott Brannan, Sanjay Misra, Haraldur Bjarnason, Aneel Ashrani, Michael Caccavale, Chad Fleming, Jeremy Friese, John Heit, Manju Kalra, Thanila Macedo, Robert McBane, Michael McKusick, Andrew Stockland, David Woodrum, Waldemar Wysokinski, Adarsh Verma, Andrew Davis, Jerry Chung, David Nicker, Brian Anderson, Robert Stein, Michael Weiss, Parag Patel, William Rilling, Sean Tutton, Robert Hieb, Eric Hohenwalter, M. Riccardo Colella, James Gosset, Sarah White, Brian Lewis, Kellie Brown, Peter Rossi, Gary Seabrook, Marcelo Guimaraes, J. Bayne Selby, William McGary, Christopher Hannegan, Jacob Robison, Thomas Brothers, Bruce Elliott, Nitin Garg, M. Bret Anderson, Renan Uflacker, Claudio Schonholz, Laurence Raney, Charles Greenberg, John Kaufman, Frederick Keller, Kenneth Kolbeck, Gregory Landry, Erica Mitchell, Robert Barton, Thomas DeLoughery, Norman Kalbfleisch, Renee Minjarez, Paul Lakin, Timothy Liem, Gregory Moneta, Khashayar Farsad, Ross Fleischman, Loren French, Vasco Marques, Yasir Al−Hassani, Asad Sawar, Frank Taylor, Rajul Patel, Rahul Malhotra, Farah Hashemi, Marvin Padnick, Melissa Gurley, Fred Cucher, Ronald Sterrenberg, G. Reshmaal Deepthi, Gomes Cumaranatunge, Sumit Bhatla, Darick Jacobs, Eric Dolen, Pablo Gamboa, L. Mark Dean, Thomas Davis, John Lippert, Sanjeev Khanna, Brian Schirf, Jeffrey Silber, Donald Wood, J. Kevin McGraw, Lucy LaPerna, Paul Willette, Timothy Murphy, Joselyn Cerezo, Rajoo Dhangana, Sun Ho Ahn, Gregory Dubel, Richard Haas, Bryan Jay, Ethan Prince, Gregory Soares, James Klinger, Robert Lambiase, Gregory Jay, Robert Tubbs, Michael Beland, Chris Hampson, Ryan O'Hara, Chad Thompson, Aaron Frodsham, Fenwick Gardiner, Abdel Jaffan, Lawrence Keating, Abdul Zafar, Radica Alicic, Rodney Raabe, Jayson Brower, David McClellan, Thomas Pellow, Christopher Zylak, Joseph Davis, M. Kathleen Reilly, Kenneth Symington, Camerson Seibold, Ryan Nachreiner, Daniel Murray, Stephen Murray, Sandeep Saha, Gregory Luna, Kim Hodgson, Robert McLafferty, Douglas Hood, Colleen Moore, David Griffen, Darren Hurst, David Lubbers, Daniel Kim, Brent Warren, Jeremy Engel, D.P. Suresh, Eric VanderWoude, Rahul Razdan, Mark Hutchins, Terry Rounsborg, Madhu Midathada, Daniel Moravec, Joni Tilford, Joni Beckman, Mahmood Razavi, Kurt Openshaw, D. Preston Flanigan, Christopher Loh, Howard Dorne, Michael Chan, Jamie Thomas, Justin Psaila, Michael Ringold, Jay Fisher, Any Lipcomb, Timothy Oskin, Brandt Wible, Brendan Coleman, David Elliott, Gary Gaddis, C. Doug Cochran, Kannan Natarajan, Stewart Bick, Jeffrey Cooke, Ann Hedderman, Anne Greist, Lorrie Miller, Brandon Martinez, Vincent Flanders, Mark Underhill, Lawrence Hofmann, Daniel Sze, William Kuo, John Louie, Gloria Hwang, David Hovsepian, Nishita Kothary, Caroline Berube, Donald Schreiber, Brooke Jeffrey, Jonathan Schor, Jonathan Deitch, Kuldeep Singh, Barry Hahn, Brahim Ardolic, Shilip Gupta, Riyaz Bashir, Angara Koneti Rao, Manish Garg, Pravin Patil, Chad Zack, Gary Cohen, Frank Schmieder, Valdimir Lakhter, David Sacks, Robert Guay, Mark Scott, Karekin Cunningham, Adam Sigal, Terrence Cescon, Nick Leasure, Thiruvenkatasamy Dhurairaj, Patrick Muck, Kurt Knochel, Joann Lohr, Jose Barreau, Matthew Recht, Jayapandia Bhaskaran, Ranga Brahmamdam, David Draper, Apurva Mehta, James Maher, Melhem Sharafuddin, Steven Lentz, Andrew Nugent, William Sharp, Timothy Kresowik, Rachel Nicholson, Shiliang Sun, Fadi Youness, Luigi Pascarella, Charles Ray, Martha-Gracia Knuttinen, James Bui, Ron Gaba, Valerie Dobiesz, Ejaz Shamim, Sangeetha Nimmagadda, David Peace, Aarti Zain, Alison Palumto, Ziv Haskal, Jon Mark Hirshon, Howard Richard, Avelino Verceles, Jade Wong-You-Chong, Bertrand Othee, Rahul Patel, Bogdan Iliescu, David Williams, Joseph Gemmete, Wojciech Cwikiel, Kyung Cho, James Schields, Ranjith Vellody, Paula Novelli, Narasimham Dasika, Thomas Wakefield, Jeffrey Desmond, James Froehlich, Minhajuddin Khaja, David Hunter, Jafar Golzarian, Erik Cressman, Yvonne Dotta, Nate Schmiechen, John Marek, David Garcia, Isaac Tawil, Mark Langsfeld, Stephan Moll, Matthew Mauro, Joseph Stavas, Charles Burke, Robert Dixon, Hyeon Yu, Blair Keagy, Kyuny Kim, Raj Kasthuri, Nigel Key, Michael Makaroun, Robert Rhee, Jae−Sung Cho, Donald Baril, Luke Marone, Margaret Hseih, Kristian Feterik, Roy Smith, Geetha Jeyabalan, Jennifer Rogers, Russel Vinik, Dan Kinikini, Larry Kraiss, Michelle Mueller, Robert Pendleton, Matthew Rondina, Mark Sarfati, Nathan Wanner, Stacy Johnson, Christy Hopkins, Daniel Ihnat, John Angle, Alan Matsumoto, Nancy Harthun, Ulku Turba, Wael Saad, Brian Uthlaut, Srikant Nannapaneni, David Ling, Saher Sabri, John Kern, B. Gail Macik, George Hoke, Auh Wahn Park, James Stone, Benjamin Sneed, Scott Syverud, Kelly Davidson, Aditya Sharma, Luke Wilkins, Carl Black, Mark Asay, Daniel Hatch, Robert Smilanich, Craig Patten, S. Douglas Brown, Ryan Nielsen, William Alward, John Collins, Matthew Nokes, Randolph Geary, Matthew Edwards, Christopher Godshall, Pavel Levy, Ronald Winokur, Akhilesh Sista, David Madoff, Kyungmouk Lee, Bradley Pua, Maria DeSancho, Raffaele Milizia, Jing Gao, Gordon McLean, Sanualah Khalid, Larry Lewis, Nael Saad, Mark Thoelke, Robert Pallow, Seth Klein, Gregorio Sicard, Heather L. Gornik, Jim Julian, Stephen Kee, Lawrence Lewis, Elizabeth Magnuson, and Timothy P. Murphy

Subjects
Adult, Male, medicine.medical_specialty, Time Factors, Mechanical Thrombolysis, medicine.medical_treatment, Catheter directed thrombolysis, 030204 cardiovascular system & hematology, Iliac Vein, Article, law.invention, 03 medical and health sciences, 0302 clinical medicine, Fibrinolytic Agents, Quality of life, Randomized controlled trial, law, Surveys and Questionnaires, Internal medicine, Epidemiology, Medicine, Humans, In patient, Thrombolytic Therapy, 030212 general & internal medicine, cardiovascular diseases, Thrombus, Venous Thrombosis, business.industry, Thrombolysis, Femoral Vein, Middle Aged, medicine.disease, United States, humanities, 3. Good health, Venous thrombosis, Treatment Outcome, Quality of Life, Female, Surgery, Cardiology and Cardiovascular Medicine, business
Abstract

After deep venous thrombosis (DVT), many patients have impaired quality of life (QOL). We aimed to assess whether pharmacomechanical catheter-directed thrombolysis (PCDT) improves short-term or long-term QOL in patients with proximal DVT and whether QOL is related to extent of DVT.The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial was an assessor-blinded randomized trial that compared PCDT with no PCDT in patients with DVT of the femoral, common femoral, or iliac veins. QOL was assessed at baseline and 1 month, 6 months, 12 months, 18 months, and 24 months using the Venous Insufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym) disease-specific QOL measure and the 36-Item Short Form Health Survey (SF-36) physical component summary (PCS) and mental component summary general QOL measures. Change in QOL scores from baseline to assessment time were compared in the PCDT and no PCDT treatment groups overall and in the iliofemoral DVT and femoral-popliteal DVT subgroups.Of 692 ATTRACT patients, 691 were analyzed (mean age, 53 years; 62% male; 57% iliofemoral DVT). VEINES-QOL change scores were greater (ie, better) in PCDT vs no PCDT from baseline to 1 month (difference, 5.7; P = .0006) and from baseline to 6 months (5.1; P = .0029) but not for other intervals. SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 2.4; P = .01) but not for other intervals. Among iliofemoral DVT patients, VEINES-QOL change scores from baseline to all assessments were greater in the PCDT vs no PCDT group; this was statistically significant in the intention-to-treat analysis at 1 month (difference, 10.0; P .0001) and 6 months (8.8; P .0001) and in the per-protocol analysis at 18 months (difference, 5.8; P = .0086) and 24 months (difference, 6.6; P = .0067). SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 3.2; P = .0010) but not for other intervals. In contrast, in femoral-popliteal DVT patients, change scores from baseline to all assessments were similar in the PCDT and no PCDT groups.Among patients with proximal DVT, PCDT leads to greater improvement in disease-specific QOL than no PCDT at 1 month and 6 months but not later. In patients with iliofemoral DVT, PCDT led to greater improvement in disease-specific QOL during 24 months.

Published
2020

2. Carotid Artery Stenosis in Patients Treated for Head and Neck Cancer: A Community Based Retrospective Analysis

Author

Brian J Mitchell, Howard R Sanders, Aaron E Wagner, Wayne T. Lamoreaux, Christopher M. Lee, Jeffrey D Bunn, Robert K. Fairbanks, Ryan Nachreiner, Jason A. Call, and John S Goodman

Subjects
medicine.medical_specialty, business.industry, medicine.medical_treatment, Head and neck cancer, Gold standard, Retrospective cohort study, medicine.disease, Asymptomatic, Surgery, Radiation therapy, Stenosis, Exact test, medicine, medicine.symptom, business, Stroke
Abstract

Purpose Radiotherapy treatment to the head and neck region is associated with a higher risk of developing carotid artery stenosis (CAS). This increases the patient’s risk for future cerebral vascular events such as stroke or transient ischemic attacks. We performed a community based observational retrospective study of CAS in patients who received surgical and/or radiation therapy treatment for head and neck malignancies. Methods and Material This study is a retrospective two-site institutional study. Data from 170 patients were obtained from Sacred Heart Hospital and Holy Family Hospital in Spokane, WA, USA between 2004 and 2007. A Fisher’s exact test was used to determine the prevalence of post-treatment CAS in patients who received radiotherapy and those who received surgery alone. Results One hundred and seventy patients met the inclusion criteria for this study. Thirty patients received surgery alone, 80 patients received radiation alone, and 60 received radiation plus surgery. Patients who received radiation therapy (radiation alone and radiation plus surgery groups) had a rate of any CAS of 17.9%, while those who received surgery alone had a rate of 13.3% (P = 0.789). Comparing patients who received radiation therapy to those who received surgery alone revealed rates of clinically significant CAS of 14.2% and 10.0%, respectively (P = 0.770). There were seven cases of severe CAS, all occurring in patients who received radiation. Conclusions Our study revealed nominally higher rates of CAS in patients who received radiotherapy for head and neck cancer. CAS is associated with an increased risk of harmful cerebrovascular events such as stroke and transient ischemic attack. A “gold standard” screening algorithm and management protocol has not yet been established for these patients. Thus, more research is needed to establish a “gold standard” screening algorithm for asymptomatic CAS in head and neck cancer survivors who have received therapeutic radiotherapy treatment.

Published
2018

3. Long-term Cost-effectiveness in the Veterans Affairs Open vs Endovascular Repair Study of Aortic Abdominal Aneurysm

Author

Hosam Farouk El Sayed, Cinda Sobotta, Reba Jones, Kellie R. Brown, Henry M. Baraniewski, Amanda J. Snodgrass, C. Keith Ozaki, Fred N. Littooy, Roderick A. Barke, Christian De Virgillio, Richard J. Massen, Anne S. Irwin, Gregory L. Moneta, George Pisimisis, Sister Frances Randall, Sheila M. Coogan, Joseph S. Giglia, Caron Rockman, Richard L. McCann, David Whitley, Erika R. Ketteler, Jeffrey H. Lawson, Matthew W. Mell, John L. Gray, Angela G. Vouyouka, Howard Greisler, Roy M. Fujitani, John W. Hallett, James M. Goff, Kathleen Hickson, Elizabeth Latts, Claudia Yales, Margaret Antonelli, Mina Behdad, Andrea M. Escalante, Karen Chong, Stephen M. Kubaska, Jorge Lopez, Joseph J. Cullen, Glenn C. Hunter, Brenda J. Jasper, John M. Marek, Kimberly Yan, Dennis F. Bandyk, June Poulton, Thomas S. Burdick, Bassem Safadi, Richard J. Gusberg, Sally Reinhardt, Erik Owens, Randy Baum, Robert J. Guerra, Laura Ashe, Mary T. O'Sullivan, Edward Perry, Michael A. Golden, Lynn Durant, Peter H. Lin, Margaret L. Schwarze, Jennifer Poirier, Jessie M. Jean-Claude, Jane Guidot, J. David Pitcher, Elaine O'Brien, Steven J. Busuttil, Stephanie Ross, Darra D. Kingsley, Vicki Bishop, Anna Busman, Kathleen M. Swanson, Rebecca L. Reinhard, Scott Zellner, Beth A. Forbes, John L. Mills, Carmelene Joncas, Georgia Purviance, Theodore Karrison, Sherilyn Pillack, Christine Maagas, Mark Langsfeld, Nancy Oberle, Stephen G. Lalka, Clair M. Haakenson, Carlos F. Bechara, Scott A. Berceli, Murray L. Shames, Michelle A. Bhola, Mary Le Gwin, Anna Rockich, Stephen P. Johnson, Robert W. Zickler, Julie A. Freischlag, John P. Matts, Heather G. Allore, Christian Bianchi, Bernadette Aulivola, Terry O'Connor, Richard A. Yeager, Brad Johnson, Ronald M. Fairman, John F. Eidt, Melita Braganza, Alice Kossack, Rajni Mehta, Bauer E. Sumpio, David Minion, Joseph H. Rapp, Brajesh K. Lal, Michelle Endo, Jon S. Matsumura, Iraklis I. Pipinos, Melanie Estes, Girma Tefera, Mitzi Rusomaroff, Gregory J. Landry, John R. Hoch, Cindy Inman, Janice Rieder, Loretta Cole, Gary Lemmon, Shemuel B. Psalms, James M. Edwards, Ted R. Kohler, Peter R. Nelson, David A. Katz, Hugh A. Gelabert, James Ebaugh, Brian D. Lewis, Nancy N. Day, Nikhil Kansal, Glenn R. Jacobowitz, Ruth L. Bush, Reverend Michael Zeman, Sandra M. Walsh, Jill Warner-Carpenter, Catherine Cagiannos, Mark R. Nehler, Carlos H. Timaran, Prakash Chand, Leah J. Caropolo, Ling Ge, Shirley Joyner, Karen Eschberger, Mohammed Moursi, Michael P. Lilly, Susan Framberg, Christa Kallio, Robyn A. Macsata, Barbara Salabsky, Charles W. Acher, Frank A. Lederle, Jason M. Johanning, Tammy Nguyen, Gerald Treiman, Ian L. Gordon, Deanna Maples, Catherine Proebstle, Joy Kimbrough, William Farrell, Satish Muluk, Gilles Pinault, Beth Dunlap, Sandra C. Carr, William D. Jordan, Erin Olgren, Thomas A. Whitehill, Donald Beckwith, Peter Guarino, Lloyd M. Taylor, Wendy Meadows, Vanessa McBride, Subodh Arora, James Niederman, E. Lynne Kelly, Jonathan Weiswasser, David G. Glickerman, Gene Guinn, Pamela Strecker, Bart E. Muhs, Eleanor Cannady, Heron E. Rodriguez, Christopher Owens, Karen L. Wilson, Shawna Thunen, Elizabeth Davis, Stanislav V. Kasl, Shelley S. Dwyer, Julie Thornton, Maria Foster, Vickie Beach, Doghdoo D. Bahmani, Penny Vasilas, Luis R. Leon, Matthew Nalbandian, Reza Azadegan, Diane C. Robertson, Richard A. Marottoli, Ross Milner, John M. Stuart, David A. Rigberg, Nina M. Peterson, Mary Evans, David Chew, Subhash Lathi, Nadine White, Macario Riveros, Jeffrey Pollak, Timothy J. O'Leary, Yvonne Jonk, Frank T. Padberg, Richard Feldman, Stephanie Hatton-Ward, J. Gregory Modrall, Paul J. Gagne, James Wong, Kimberly Pedersen, Norman Hertzer, Brian D. Matteson, Wei Zhou, Nina Lee, Mark W. Sebastian, Steven M. Santilli, William C. Krupski, Neal Cayne, Anton N. Sidawy, Neal R. Barshes, Christina Paap, Sherry M. Wren, Alex Westerband, Sandra Brock, Vivian Gahtan, John D. Hughes, Panagiotis Kougias, Jonathan B. Towne, Michael Ranella, W. Anthony Lee, Ryan Nachreiner, Cynthia K. Shortell, Patricia A. Prinzo, Kea Ellis, Ronald L. Dalman, Thomas G. Lynch, Karthikeshwar Kasirajan, H. Edward Garrett, Joaquim J. Cerveira, Peter Peduzzi, Marcelo Spector, Carla Blackwell, Omran Abul-Khoudoud, Dolores F. Cikrit, Jean Kistler Tetterton, Martin Back, Darrell N. Jones, Darryl S. Weiman, Donna Kerns, Mark Wilson, Preet Kang, Kenneth Granke, Gary R. Johnson, Linda M. Reilly, Marilyn Bader, Lauri Lee Johnson, Ravi K. Veeraswamy, Sandra L. Perez, W. John Sharp, Gary R. Seabrook, Karthnik Kasirajan, Brenda Allende, John D. Corson, Kathy Zalecki, Joseph D. Raffetto, Thomas H. Schwarcz, Mark A. Patterson, Matthew Eiseman, John K.Y. Chacko, Mark Adelman, Holly De Spiegelaere, Alan Dardik, Madeline Ruf, Kevin T. Stroupe, Grant D. Huang, M. Burress Welborn, Alexandre C. D'Audiffret, Rajaabrata Sarkar, Michael Sobel, Steve M. Taylor, Barbara Guillory, Sandra C. Thomas, Thomas S. Hatsukami, Robert A. Cambria, Jeanne L. McCandless, Susan Stratton, Cindy Cushing, Karen A. Hauck, Atef Salam, Melina R. Kibbe, Tassos C. Kyriakides, Amy B. Reed, Jason T. Lee, Jamal J. Hoballah, Marc E. Mitchell, Hasan H. Dosluoglu, Marc A. Passman, Edith Tzeng, Patricia Cleary, and John Aruny

Subjects
Diagnostic Imaging, Male, medicine.medical_specialty, Time Factors, Cost effectiveness, Cost-Benefit Analysis, Comparative effectiveness research, 030204 cardiovascular system & hematology, 030230 surgery, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Humans, Medicine, cardiovascular diseases, Veterans Affairs, health care economics and organizations, Aged, Intention-to-treat analysis, business.industry, Endovascular Procedures, Health Care Costs, Length of Stay, Middle Aged, medicine.disease, Abdominal aortic aneurysm, Quality-adjusted life year, Surgery, Elective Surgical Procedures, Quality of Life, Health Resources, Female, Quality-Adjusted Life Years, business, Aortic Aneurysm, Abdominal, Follow-Up Studies, Abdominal surgery
Abstract

Importance Because of the similarity in clinical outcomes after elective open and endovascular repair of abdominal aortic aneurysm (AAA), cost may be an important factor in choosing a procedure. Objective To compare total and AAA-related use of health care services, costs, and cost-effectiveness between groups randomized to open or endovascular repair. Design, Setting, and Participants This unblinded randomized clinical trial enrolled 881 patients undergoing planned elective repair of AAA who were candidates for open and endovascular repair procedures. Patients were randomized from October 15, 2002, to April 15, 2008, at 42 Veterans Affairs medical centers. Follow-up was completed on October 15, 2011, and data were analyzed from April 15, 2013, to April 15, 2016, based on intention to treat. Main Outcomes and Measures Mean total and AAA-related health care cost per life-year and per quality-adjusted life-year (QALY). Results A total of 881 patients (876 men [99.4%]; 5 women [0.6%]; mean [SD] age, 70 [7.8] years) were included in the analysis. After a mean of 5.2 years of follow-up, mean life-years were 4.89 in the endovascular group and 4.84 in the open repair group ( P = .68), and mean QALYs were 3.72 in the endovascular group and 3.70 in the open repair group ( P = .82). Total mean health care costs did not differ significantly between the 2 groups (endovascular group, $142 745; open repair group, $153 533; difference, −$10 788; 95% CI, −$29 796 to $5825; P = .25). Costs related to AAA, including the initial repair, constituted nearly 40% of total costs and did not differ significantly between the 2 groups (endovascular group, $57 501; open repair group, $57 893; difference, −$393; 95% CI, −$12 071 to $7928; P = .94). Lower costs due to shorter hospitalization for initial endovascular repair were offset by increased costs from AAA-related secondary procedures and imaging studies. The probability of endovascular repair being less costly and more effective was 56.8% when effectiveness was measured in life-years and 55.4% when effectiveness was measured in QALYs for total costs and 31.3% and 34.3%, respectively, for AAA-related costs. Conclusions and Relevance In this multicenter randomized clinical trial with follow-up to 9 years, survival, quality of life, costs, and cost-effectiveness did not differ between elective open and endovascular repair of AAA. Trial Registration clinicaltrials.gov Identifier:NCT00094575

Published
2016

4. Costs of repair of abdominal aortic aneurysm with different devices in a multicenter randomized trial

Author

Jon S. Matsumura, Kevin T. Stroupe, Frank A. Lederle, Tassos C. Kyriakides, Ling Ge, Julie A. Freischlag, Erika R. Ketteler, Darra D. Kingsley, John M. Marek, Richard J. Massen, Brian D. Matteson, J. David Pitcher, Mark Langsfeld, John D. Corson, James M. Goff, Karthnik Kasirajan, Christina Paap, Diane C. Robertson, Atef Salam, Ravi Veeraswamy, Ross Milner, Karthikeshwar Kasirajan, Jane Guidot, Brajesh K. Lal, Steven J. Busuttil, Michael P. Lilly, Melita Braganza, Kea Ellis, Mark A. Patterson, William D. Jordan, David Whitley, Steve Taylor, Marc Passman, Donna Kerns, Cindy Inman, Jennifer Poirier, James Ebaugh, Joseph Raffetto, David Chew, Subhash Lathi, Christopher Owens, Kathleen Hickson, Hasan H. Dosluoglu, Karen Eschberger, Melina R. Kibbe, Henry M. Baraniewski, Jon Matsumura, Michelle Endo, Anna Busman, Wendy Meadows, Mary Evans, Joseph S. Giglia, Hosam El Sayed, Amy B. Reed, Madeline Ruf, Stephanie Ross, Jessie M. Jean-Claude, Gilles Pinault, Preet Kang, Nadine White, Matthew Eiseman, Reba Jones, Carlos H. Timaran, J. Gregory Modrall, M. Burress Welborn, Jorge Lopez, Tammy Nguyen, John K.Y. Chacko, Kenneth Granke, Angela G. Vouyouka, Erin Olgren, Prakash Chand, Brenda Allende, Michael Ranella, Claudia Yales, Thomas A. Whitehill, William C. Krupski, Mark R. Nehler, Stephen P. Johnson, Darrell N. Jones, Pamela Strecker, Michelle A. Bhola, Cynthia K. Shortell, John L. Gray, Jeffrey H. Lawson, Richard McCann, Mark W. Sebastian, Jean Kistler Tetterton, Carla Blackwell, Patricia A. Prinzo, Nina Lee, Frank T. Padberg, Joaquim J. Cerveira, Robert W. Zickler, Karen A. Hauck, Scott A. Berceli, W. Anthony Lee, C. Keith Ozaki, Peter R. Nelson, Anne S. Irwin, Randy Baum, Bernadette Aulivola, Heron Rodriguez, Fred N. Littooy, Howard Greisler, Mary T. O'Sullivan, Panagiotis Kougias, Peter H. Lin, Ruth L. Bush, Gene Guinn, Catherine Cagiannos, Sherilyn Pillack, Barbara Guillory, Dolores Cikrit, Stephen G. Lalka, Gary Lemmon, Ryan Nachreiner, Mitzi Rusomaroff, Elaine O'Brien, Joseph J. Cullen, Jamal Hoballah, W. John Sharp, Jeanne L. McCandless, Vickie Beach, David Minion, Thomas H. Schwarcz, Joy Kimbrough, Laura Ashe, Anna Rockich, Jill Warner-Carpenter, Mohammed Moursi, John F. Eidt, Sandra Brock, Christian Bianchi, Vicki Bishop, Ian L. Gordon, Roy Fujitani, Stephen M. Kubaska, Mina Behdad, Reza Azadegan, Christine Ma Agas, Kathy Zalecki, John R. Hoch, Sandra C. Carr, Charles Acher, Margaret Schwarze, Girma Tefera, Matthew Mell, Beth Dunlap, Janice Rieder, John M. Stuart, Darryl S. Weiman, Omran Abul-Khoudoud, H. Edward Garrett, Sandra M. Walsh, Karen L. Wilson, Gary R. Seabrook, Robert A. Cambria, Kellie R. Brown, Brian D. Lewis, Susan Framberg, Christa Kallio, Roderick A. Barke, Steven M. Santilli, Alexandre C. d'Audiffret, Nancy Oberle, Catherine Proebstle, Lauri Lee Johnson, Glenn R. Jacobowitz, Neal Cayne, Caron Rockman, Mark Adelman, Paul Gagne, Matthew Nalbandian, Leah J. Caropolo, Iraklis I. Pipinos, Jason Johanning, Thomas Lynch, Holly DeSpiegelaere, Georgia Purviance, Wei Zhou, Ronald Dalman, Jason T. Lee, Bassem Safadi, Sheila M. Coogan, Sherry M. Wren, Doghdoo D. Bahmani, Deanna Maples, Shawna Thunen, Michael A. Golden, Marc E. Mitchell, Ronald Fairman, Sally Reinhardt, Mark A. Wilson, Edith Tzeng, Satish Muluk, Nina M. Peterson, Maria Foster, James Edwards, Gregory L. Moneta, Gregory Landry, Lloyd Taylor, Richard Yeager, Eleanor Cannady, Gerald Treiman, Stephanie Hatton-Ward, Barbara Salabsky, Nikhil Kansal, Erik Owens, Melanie Estes, Beth A. Forbes, Cinda Sobotta, Joseph H. Rapp, Linda M. Reilly, Sandra L. Perez, Kimberly Yan, Rajaabrata Sarkar, Shelley S. Dwyer, Ted R. Kohler, Thomas S. Hatsukami, David G. Glickerman, Michael Sobel, Thomas S. Burdick, Kimberly Pedersen, Patricia Cleary, Martin Back, Dennis Bandyk, Brad Johnson, Murray Shames, Rebecca L. Reinhard, Sandra C. Thomas, Glenn C. Hunter, Luis R. Leon, Alex Westerband, Robert J. Guerra, Macario Riveros, John L. Mills, John D. Hughes, Andrea M. Escalante, Shemuel B. Psalms, Nancy N. Day, Robyn Macsata, Anton Sidawy, Jonathan Weiswasser, Subodh Arora, Brenda J. Jasper, Alan Dardik, Vivian Gahtan, Bart E. Muhs, Bauer E. Sumpio, Richard J. Gusberg, Marcelo Spector, Jeffrey Pollak, John Aruny, E. Lynne Kelly, James Wong, Penny Vasilas, Carmelene Joncas, Hugh A. Gelabert, Christian DeVirgillio, David A. Rigberg, and Loretta Cole

Subjects
medicine.medical_specialty, Time Factors, medicine.medical_treatment, Prosthesis Design, Endovascular aneurysm repair, law.invention, Blood Vessel Prosthesis Implantation, Aortic aneurysm, Randomized controlled trial, law, Blood vessel prosthesis, Health care, medicine, Humans, Hospital Costs, Veterans Affairs, health care economics and organizations, Health economics, business.industry, Endovascular Procedures, Health Care Costs, Length of Stay, medicine.disease, United States, Abdominal aortic aneurysm, Blood Vessel Prosthesis, Surgery, United States Department of Veterans Affairs, Treatment Outcome, Stents, Health Expenditures, Cardiology and Cardiovascular Medicine, business, Aortic Aneurysm, Abdominal
Abstract

Objective Prior analysis in the Open vs Endovascular Repair Veterans Affairs (VA) Cooperative Study (CSP #498) demonstrated that survival, quality of life, and total health care costs are not significantly different between the open and endovascular methods of repair of abdominal aortic aneurysm. The device is a major cost of this method of repair, and the objective of this study was to evaluate the costs of the device, abdominal aortic aneurysm repair, and total health care costs when different endograft systems are selected for the endovascular repair (EVR). Within each selected system, EVR costs are compared with open repair costs. Methods The study randomized 881 patients to open (n = 437) or EVR (n = 444). Device selection was recorded before randomization; therefore, open repair controls were matched to each device cohort. Data were excluded for two low-volume devices, implanted in only 13 individuals, leaving 423 control and 431 endovascular patients: 166 Zenith (Cook Medical, Bloomington, Ind), 177 Excluder (W. L. Gore & Associates, Flagstaff, Ariz), and 88 AneuRx (Medtronic, Minneapolis, Minn). Mean device, hospitalization, and total health care costs from randomization to 2 years were compared. Health care utilization data were obtained from patients and national VA and Medicare data sources. VA costs were determined using methods previously developed by the VA Health Economics Resource Center. Non-VA costs were obtained from Medicare claims data and billing data from the patient's health care providers. Results Implant costs were 38% of initial hospitalization costs. Mean device (range, $13,600-$14,400), initial hospitalization (range, $34,800-$38,900), and total health care costs at 2 years in the endovascular (range, $72,400-$78,200) and open repair groups (range, $75,600-$82,100) were not significantly different among device systems. Differences between endovascular and corresponding open repair cohorts showed lower mean costs for EVR (range, $3200-$8300), but these were not statistically different. Conclusions The implant costs of endovascular aneurysm repair are substantial. When evaluating total health care system expenditures, there is large individual variability in costs, and there is no significant difference at 2 years among systems or when an individual system is compared with open repair.

Published
2015

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