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3. First-in-Human Multicenter Experience of the Newest Generation Supra-Annular Self-Expanding Evolut FX TAVR System

Author

Zaid, Syed, Attizzani, Guilherme F., Krishnamoorthy, Parasuram, Yoon, Sung-Han, Palma Dallan, Luis A., Chetcuti, Stanley, Fukuhara, Shinichi, Grossman, P. Michael, Goel, Sachin S., Atkins, Marvin D., Kleiman, Neal S., Puri, Rishi, Bakhtadze, Beka, Byrne, Timothy, Ibrahim, Akram W., Grubb, Kendra J., Tully, Andy, Herrmann, Howard C., Faggioni, Michela, Ramlawi, Basel, Khera, Sahil, Lerakis, Stamatios, Dangas, George D., Kini, Annapoorna S., Sharma, Samin K., Reardon, Michael J., and Tang, Gilbert H.L.

Published
2023
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8. 1-Year Results in Patients Undergoing Transcatheter Aortic Valve Replacement With Failed Surgical Bioprostheses

Author

Deeb, G. Michael, Chetcuti, Stanley J., Reardon, Michael J., Patel, Himanshu J., Grossman, P. Michael, Schreiber, Theodore, Forrest, John K., Bajwa, Tanvir K., O’Hair, Daniel P., Petrossian, George, Robinson, Newell, Katz, Stanley, Hartman, Alan, Dauerman, Harold L., Schmoker, Joseph, Khabbaz, Kamal, Watson, Daniel R., Yakubov, Steven J., Oh, Jae K., Li, Shuzhen, Kleiman, Neal S., Adams, David H., and Popma, Jeffrey J.

Published
2017
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12. Multifaceted Intervention to Improve P2Y12 Inhibitor Adherence After Percutaneous Coronary Intervention: A Stepped Wedge Trial

Author

Ho, P. Michael, primary, O’Donnell, Colin I., additional, McCreight, Marina, additional, Bavry, Anthony A., additional, Bosworth, Hayden B., additional, Girotra, Saket, additional, Grossman, P. Michael, additional, Helfrich, Christian, additional, Latif, Faisal, additional, Lu, David, additional, Matheny, Michael, additional, Mavromatis, Kreton, additional, Ortiz, Jose, additional, Parashar, Amitabh, additional, Ratliff, Devona M., additional, Grunwald, Gary K., additional, Gillette, Michael, additional, and Jneid, Hani, additional

Published
2022
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15. Aortic valve reintervention in patients with failing transcatheter aortic bioprostheses: A statewide experience

Author

Fukuhara, Shinichi, primary, Tanaka, Daizo, additional, Brescia, Alex A., additional, Wai Sang, Stephane Leung, additional, Grossman, P. Michael, additional, Sukul, Devraj, additional, Chetcuti, Stanley J., additional, He, Chang, additional, Eng, Marvin H., additional, Patel, Himanshu J., additional, and Deeb, G. Michael, additional

Published
2021
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16. The Relationship between Rate and Volume of Intravenous Fluid Administration and Kidney Outcomes after Angiography

Author

Soomro, Qandeel H., Anand, Sonia T., Weisbord, Steven D., Gallagher, Martin P., Ferguson, Ryan E., Palevsky, Paul M., Bhatt, Deepak L., Parikh, Chirag R., Kaufman, James S., Brophy, Mary, Chertow, Glenn, Conner, Todd, Ferguson, Ryan, Fine, M., Kaufman, James, Lew, Robert, McCullough, Peter, Palevsky, Paul, Parikh, Chirag, Ringer, Robert, Shunk, Kendrick, Soliva, Susan, Weisbord, Steven, Bhatt, Deepak, Cass, Alan, Gallagher, Martin, McFalls, Edward, Pirakh, Chirag, Wu, Hongsheng, Ratliff, Michelle, Ketteler, Erika, Goff, James, Snider, Richard, Jones, Debra, Kreuch, Jeannie, Duvernoy, Claire, Thomas, Michael, Willatt, Jonathan, Gurm, Hitinder, Krishnamurthy, Venkat, Nallamothu, Brahmajee, Szymanski, Kendra, Grossman, P. Michael, Menees, Daniel, Rose, Patricia, Mavromatis, Kreton, Kumar, Gautam, Raghavan, Sumati, Dow, Jeanne, Mandawat, Mahendra, Noe, Susan, Alavi, Hossain, Calkins, Joe, McNear, Jennifer, Beals, Donald, Cavalieri, Stuart, Sierzega, Renata, Pearson, Laura, Afaq, Mazhar, Vaitkus, Paul, Kudryk, Bruce, Hall, Dennis, Nadella, Neelima, Corin, William, Woklu, Nina, Inting-Toothman, Stella, Wescott, Lea, Ventura, Nicole, Kinlay, Scott, Croce, Kevin, Faxon, David, Vokonas, Pantel, Raffetto, Joseph, McPhee, James, Gupta, Naren, Nava, Adrianna, Ly, Samantha, My-Do, Jacquelyn, Ostrowski, Simon, Bundy, Mariah, Quinn, Margot, Chin, Melissa, Corbelli, John, Dosluoglu, Hasan, Lohr, James, Rivero, Mariel, Cooke, Beth, Galla, Ann, Cloen, Denise, Fernandes, Valerian, DiBona, Alexander, Nielsen, Christopher, Idleman, Lois, Lee, Bertha, Vidovich, Mladen, Kibbe, Melina, Griza, Decebal, Raicu, Mihai, Rothenberg, Florence, Thakar, Charuhas, Madabhushi, Aditi, Arif, Imran, Bath, Jonathan, Helmy, Tarek, Unterbrink, Kendra, Ross, Stephanie, Bailey, Cathy, Hailes, Myrtle, Goldberg, Jonathan, Jozic, Joseph, Kang, Preet, Kalman, Jeaniene, Rosenthal, Noah, Catania, Deborah, Marlow, Jeanne, Kumaran, Vinay, Krupka, Angela, Zappernick, Taissa, Brilakis, Emmanouil, Tsai, Shirling, Banerjee, Subhash, Modrall, J. Gregory, Roesle, Michele, Hamilton, Marcie, Lusk, Cassie, Compton, Jennifer, Willis, Cyenthia, Atwell, Amy, Soto-Gonzalez, Marilisa, Agarwal, Ajay, Saklayen, Mohammad, Woerner, Donna, Ross, Jeffrey, Turner, Karen, Zheng-Phelan, Ling, Rider, Kamia, Rao, Sunil, Jones, W. Schuyler, Povsic, Thomas, Krucoff, Mitchell, Brennan, James, Miller, Michael, Mureebe, Leila, Aristy, Kathy, Powell, Marilyn, Bavry, Anthony, Choi, Calvin, Park, Ki, Curry, Tempa, Robertson, Debra, Wright, Cila, Jneid, Hani, Paniagua, David, Denktas, Ali, Lara-Smalling, Agueda, Palmer, Leah, Malarchick, Jo Ann, Broussard, Emily, Bolad, Islam, Breall, Jeffrey, Motaganahalli, Raghunandan, English, Beth, Ramkaransingh, Jeffrey, Mukerji, Rita, Subbarao, Roopa, Williams, Vicki, Henson, Sharon, Krier, Connie, Parashara, Deepak, Ciniglio, Ricardo, Barua, Rajat, Roys, Michael, Surineni, Kamalakar, Mendes, Kimberley, Oni, Olurinde, Uretsky, Barry, Ahmed, Zubair, Yousaf, Muhammad, Hakeem, Abdul, Chung, Hui Yong, Miller, Kristin, Dishongh, Katherine, Ramanathan, Kodangudi, Shah, Rahman, McGee, Jesse, Qualls, Zoe, Armstrong, Ashley, Johnson, Lillie, Garcia, Santiago, Adabag, Selcuk, Vakil, Kairav, Nguyen, Jennifer, Berg, Matthew, Herrmann, Rebekah, Condon, Debra, Meyeraan, Tacy, Sedlis, Steven, Lorin, Jeffrey, Keary, Mary, Shah, Binita, Maranan, Leandro, Latif, Faisal, Thadani, Udho, Abu-Fadel, Mazen, Exaire, Jose, Rousan, Talla, Ramirez-Jimenez, Arleen, Pham, Trang, Giacomini, John, Lit, Yiming, Massaband, Payam, Yong, Celina, Fearon, William, Zhou, Wei, Aalami, Oliver, Peters, Theresa, Bratcher, Karen, Monteverde, Edgardo, Rahman, Aref, Bandi, Rupal, Garbelotti, Kelly, Mulukutla, Suresh, Overberger, Pamela, Watnick, Suzanne, Davies, Crispin, Larsen, Greg, Atkinson, Tamara, Walczyk, Jacqueline, Kenworthy-Heinige, Tawni, Guenther, Stephanie, Pitts, Alexandra, Jovin, Ion, Minisi, Anthony, Sumption, Kevin, Feldman, George, Ha, Jonathan, Hendrix, Mack, Maldonado, Maureen, Jeter, Deborah, Klein, Andrew, Forsberg, Michael, Rowe, Caroline, Nasir, Ammar, Mani, Kartik, Vercher, Paul, Waidmann, Kristi, Vargo, Kristin, Chilakapati, Venkata, Jarmukli, Nabil, Tan, Shen-Li, Sherigar, Rathnakara, Bottomley, Sharon, Capuno, Maribeth, Henley, Katherine, Dev, Devasmita, Mathew, Jacob, Ochalek, Tracy, Lui, Charles, Smith, Brigham, Huo, Eugene, Frodsham, Aaron, Eskelson, Noni, Velarde, Kandi, Dulin, Heather, Martinez, Lillian, Zimmet, Jeffrey, Sawhney, Rajiv, Malik, Fady, Chou, Tony, Huynh, Cynthia, Stanley, Kathleen, Garcia, Epifanio, Lehmann, Kenneth, Stadius, Michael, Beatty, Alexis, Naria, Sohilkumar, Galvin, Georgia, Chilton, Robert, Pham, Son, Oliveros, Rene, Hecht, Joan, Thai, Hoang, Truong, Huu Tam, Goldman, Steven, Thal, Sergio, Juneman, Elizabeth, Kapoor, Divya, Tsuda, Ryan, Kipps, Juliana, Mikhail, Amani, Sandoval, Michael, Currier, Jesse, Lee, Hsin-Yi, Chang, Donald, Walsworth, Matthew, Warner, Alberta, Chen, Alice, Lendvai, Dora, Johnson, Janet, Lee, Joanne, Coggan, Sarah, Kumar, Namrata Nath, Dempsey, Erika, Kotwal, Sradha, Smyth, Brendan, Yianni, Alexia, Lee, Li Hui, Cheong, Siew Yan, Yates, Casey, James, Earl, Talaulikar, Girish, Farshid, Ahmad, Johnson, Patricia, Taverner, Pearle, Chadwick, Heather, Stewart, Ralph, Benatar, Jocelyne, Stone, Louise, Howell, Leah, Anderson, Sue, Lehnhard, Siobhan, Patten, Cathrine, Farouque, Omar, Bellomo, Rinaldo, Horrigan, Mark, Scott, Peter, Jones, Nicolas, Yudi, Matias, Huq, Rafi, Al-Fiadh, Ali, Brown, Louise, Brieger, David, Hillis, Graham, Cherry, Jonathan, Aitken, Sarah, Anastasius, Malcom, Lau, Jerrett, Lowe, Harry, Ayoub, Chadi, Jardine, Meg, O?Connor, Jody, Wong, Christopher, Wu, June, Xu, Kitty, Webster, Julie, Mwaijele, Liliang, Hand, Samantha, Chew, Derek, Alyward, Philip, Balakrishnan, Deepu, Prakash, Roshan, Pathik, Bhupesh, Kinatra, Vineet, Jones, Dylan, Singh, Arun, Ratib, Karim, Hammad, Nassser Al, Gunton, James, Mazhar, Jawad, Musameh, Muntaser, O?Shea, Catherine, Judd, Jo, Raman, Betty, Wollaston, Fiona, Felice, Kerri Ann, Hincks, Christine, Harrison, Timothy, Fawcett, Malcolm, Wright, Therese, Horsfall, Lee-Anne, Kissajukian, Francis, Murphy, Diedre, Bartlett, Pamela, Stockle, Paul, William, Maged, Elsokkari, Ihab, Rangasamy, Karthikeyan, Roy, Probal, Tran, David, Hayat, Muhammed Umair, May, Austin, Nyakudarika, Elijah, Phang, Calvin, Conway, Bets, O?Donoghue, Michelle, Ellis, Katrina, Kanna, Rajesh, Hendriks, Randall, Forrest, Nicole, Tulloch, Gill, Greenwell, Della, Ghapar, Abd Kahar, Ghani, Abdul Raqib Abd, Sundaralingam, Shamini, Fuah, K., Habizal, Nor Halwani, Daud, Siti Rohaya, Haq, Hafsah Begum binti Abdul, Mohammad, Masliza Binti, Hassan, Faizah Che, Hashim, Hanani, Ismail, Omar, Kong, Poi Keong, Ma, Soot Keng, Wahab, Mohamed Jahangir Abdul, Abdulla, Zarina Banu, Kader, Mohamad Ali Sheikh Abdul, Goh, Chong Aik, Ahmadsha, Shahul Hamid, Naser, Mohamad Nazrulhisham Mad, Yusuf, Azizah, Govindasamy, Paramesveri, Ibrahim, Nur Azliati Binti, Yahaya, Normilah, Juergens, Craig, French, John, Mussap, C., Lo, Sidney, Burgess, S., Mallard, Trevor, Huang, Justin, Kumar, Manish, Lee, Adam, Leung, Dominic, Badie, Tamar, Xu, James, Terluk, Andrew, Croucher, Alexandria, O?Brien, Kelsey, Raynes, Suzanne, Plotz, Maria, Hallani, Hisham, Fernandes, Clyne, Fitzpatrick, Drew, Parikh, Devang, Coulshed, David, Pathan, Faraz, Ganda, Prashil, Chandrala, Pavan, Barry, Lisa, Mackenzie, Michele, VanGaal, William, Hyat, Umair, Tsay, It Men, Subiakto, Ivan, Cresp, Damian, Nelson, Gregory, Mau, James, Shaw, Elizabeth, Yan, Warren, Arena, Frank, Danson, Edward, Vernon, S., Ward, Michael, Allahwala, U., Reid, Emma, Straiton, Nicola, Whitley, Alexandra, Loxton, Annie, Erickson, Royal Perth Hospital: Matthew, Ihdayid, Abdul-Rhman, Dias, Peter, Atique, Syed, Bonner, Michelle, Venn-Edmonds, Clare, Prasan, Ananth, Sader, Mark, Ramsay, David, Ford, Tom, Weaver, James, Binnekamp, Maurits, Barrett, David, Roy, James, Ng, Ben, Youssef, George, Shrestha, Prakriti, Vrachas, Deborah, Dobinson, Kate, Ternouth, Ian, Lumb, Nicky, Sebastian, Jeffrey, Jackson, Carolyn, Vickers, Cathy, Prideaux, Jan, Ahmad, Wan Azman Wan, Abidin, Imran Zainal, Zuhdi, Ahmad Syadi Mahmood, Ismail, Muhammad Dzafir, Sridhar, Ganiga Srinivasaiah, Lim, Soo Kun, Hadi, Moud Firdaus, Adnan, Wan Ahmad Hafiz Wan Md, Kassim, Zainab Abu, Mansor, Syed Mukhtar Syed, Lee, Vin-Zhen, Harding, Scott, Ranchord, Anil, Matsis, Philip, Aitken, Andrew, Simmonds, Mark Bernard, Fairley, Sarah, Wolbinski, Mariusz, Plunkett, Susan, Sinan, Ali Al, Ferrier, Katherine, O?Meeghan, Tim, Wilkins, Ben, Anscomise, Russell, Sasse, Alexander, Kirby, Alyssa, Ershad, Shakiya, Smyth, Duncan, Lim, Ren Yik, Middleditch, Diane, and Davies, Bronwyn

Published
2022
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17. Early Structural Valve Degeneration of Trifecta Bioprosthesis

Author

Fukuhara, Shinichi, primary, Shiomi, Suzuna, additional, Yang, Bo, additional, Kim, Karen, additional, Bolling, Steven F., additional, Haft, Jonathan, additional, Tang, Paul, additional, Pagani, Francis, additional, Prager, Richard L., additional, Chetcuti, Stanley, additional, Grossman, P. Michael, additional, Patel, Himanshu J., additional, and Deeb, G. Michael, additional

Published
2020
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18. Self-Expanding Transcatheter Aortic Valve Replacement in Patients With Low-Gradient Aortic Stenosis

Author

Chetcuti, Stanley J., primary, Deeb, G. Michael, additional, Popma, Jeffrey J., additional, Yakubov, Steven J., additional, Grossman, P. Michael, additional, Patel, Himanshu J., additional, Casale, Alfred, additional, Dauerman, Harold L., additional, Resar, Jon R., additional, Boulware, Michael J., additional, Dries-Devlin, Jessica L., additional, Li, Shuzhen, additional, Oh, Jae K., additional, and Reardon, Michael J., additional

Published
2019
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19. Safety and efficacy of thrombectomy in patients undergoing primary percutaneous coronary intervention for Acute ST elevation MI: A Meta-Analysis of Randomized Controlled Trials

Author

Grossman P Michael, Hameed Irfan, Chetcuti Stanley, Tamhane Umesh U, Moscucci Mauro, and Gurm Hitinder S

Subjects
Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Abstract Background Clinical trials comparing thrombectomy devices with conventional percutaneous coronary interventions (PCI) in patients with acute ST elevation myocardial infarction (STEMI) have produced conflicting results. The objective of our study was to systematically evaluate currently available data comparing thrombectomy followed by PCI with conventional PCI alone in patients with acute STEMI. Methods Seventeen randomized trials (n = 3,909 patients) of thrombectomy versus PCI were included in this meta-analysis. We calculated the summary odds ratios for mortality, stroke, post procedural myocardial blush grade (MBG), thrombolysis in myocardial infarction (TIMI) grade flow, and post procedural ST segment resolution (STR) using random-effects and fixed-effects models. Results There was no difference in risk of 30-day mortality (44/1914 vs. 50/1907, OR 0.84, 95% CI 0.54-1.29, P = 0.42) among patients randomized to thrombectomy, compared with conventional PCI. Thrombectomy was associated with a significantly greater likelihood of TIMI 3 flow (1616/1826 vs. 1533/1806, OR 1.41, P = 0.007), MBG 3 (730/1526 vs. 486/1513, OR 2.42, P < 0.001), STR (923/1500 vs. 715/1494, OR 2.30, P < 0.001), and with a higher risk of stroke (14/1403 vs. 3/1413, OR 2.88, 95% CI 1.06-7.85, P = 0.04). Outcomes differed significantly between different device classes with a trend towards lower mortality with manual aspiration thrombectomy (MAT) (21/949 vs.36/953, OR 0.59, 95% CI 0.35-1.01, P = 0.05), whereas mechanical devices showed a trend towards higher mortality (20/416 vs.10/418, OR 2.07, 95% CI 0.95-4.48, P = 0.07). Conclusions Thrombectomy devices appear to improve markers of myocardial perfusion in patients undergoing primary PCI, with no difference in overall 30-day mortality but an increased likelihood of stroke. The clinical benefits of thrombectomy appear to be influenced by the device type with a trend towards survival benefit with MAT and worsening outcome with mechanical devices.

Published
2010
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20. Impact of Annular Size on Outcomes After Surgical or Transcatheter Aortic Valve Replacement

Author

Deeb, G. Michael, primary, Chetcuti, Stanley J., additional, Yakubov, Steven J., additional, Patel, Himanshu J., additional, Grossman, P. Michael, additional, Kleiman, Neal S., additional, Heiser, John, additional, Merhi, William, additional, Zorn, George L., additional, Tadros, Peter N., additional, Petrossian, George, additional, Robinson, Newell, additional, Mumtaz, Mubashir, additional, Gleason, Thomas G., additional, Huang, Jian, additional, Conte, John V., additional, Popma, Jeffrey J., additional, and Reardon, Michael J., additional

Published
2018
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22. 3-Year Outcomes in High-Risk Patients Who Underwent Surgical or Transcatheter Aortic Valve Replacement

Author

Deeb, G. Michael, primary, Reardon, Michael J., additional, Chetcuti, Stan, additional, Patel, Himanshu J., additional, Grossman, P. Michael, additional, Yakubov, Steven J., additional, Kleiman, Neal S., additional, Coselli, Joseph S., additional, Gleason, Thomas G., additional, Lee, Joon Sup, additional, Hermiller, James B., additional, Heiser, John, additional, Merhi, William, additional, Zorn, George L., additional, Tadros, Peter, additional, Robinson, Newell, additional, Petrossian, George, additional, Hughes, G. Chad, additional, Harrison, J. Kevin, additional, Maini, Brijeshwar, additional, Mumtaz, Mubashir, additional, Conte, John, additional, Resar, Jon, additional, Aharonian, Vicken, additional, Pfeffer, Thomas, additional, Oh, Jae K., additional, Qiao, Hongyan, additional, Adams, David H., additional, and Popma, Jeffrey J., additional

Published
2016
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23. Phase I study of multi-gene cell therapy in patients with peripheral artery disease

Author

Grossman, P Michael, primary, Mohler, Emile R, additional, Roessler, Blake J, additional, Wilensky, Robert L, additional, Levine, Bruce L, additional, Woo, Edward Y, additional, Upchurch, Gilbert R, additional, Schneiderman, Jacob, additional, Koren, Belly, additional, Hutoran, Marina, additional, Gershstein, Diana, additional, and Flugelman, Moshe Y, additional

Published
2015
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24. If not now, when? Prescription of evidence-based medical therapy prior to hospital discharge increases utilization at 6 months in patients with symptomatic peripheral artery disease

Author

Renard, Brian M, primary, Seth, Milan, additional, Share, David, additional, Aronow, Herb D, additional, Laveroni, Eugene W, additional, De Gregorio, Michele, additional, Hans, Sachinder S, additional, Henke, Peter K, additional, Gurm, Hitinder S, additional, and Grossman, P Michael, additional

Published
2015
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26. Phase I study of multi-gene cell therapy in patients with peripheral artery disease.

Author

Grossman, P. Michael, Mohler, Emile R., Roessler, Blake J., Wilensky, Robert L., Levine, Bruce L., Woo, Edward Y., Upchurch, Gilbert R., Schneiderman, Jacob, Koren, Belly, Hutoran, Marina, Gershstein, Diana, and Flugelman, Moshe Y.

Subjects
*ARTERIAL disease treatment, *CELLULAR therapy, *GENE therapy, *VASCULAR endothelial growth factors, *ANGIOPOIETIN-1
Abstract

Alternative treatment strategies for claudication are needed and cell-based therapies designed to induce angiogenesis are promising. The purpose of this report was to conduct a Phase I safety, dose-escalating, non-randomized, open-label study of autologous, fully differentiated venous endothelial and smooth muscle cells called MultiGeneAngio (MGA) for claudication due to peripheral artery disease. Twelve subjects, at two centers, received a single intra-arterial infusion of a suspension of equal amounts of transduced autologous venous smooth muscle cells expressing vascular endothelial growth factor (VEGF165) and endothelial cells expressing angiopoietin-1 (Ang-1) (Cohort 1: 1 × 107, Cohort 2: 2 × 107, Cohort 3: 5 × 107, Cohort 4: 7 × 107). The treatment was given unblinded and in the more symptomatic lower extremity. Transduced cells were tested for in vitro doubling time, telomerase activity, and gene expression. The main outcomes were clinical safety and tolerability. Other safety measures included ankle–brachial index (ABI) and walking time on a treadmill. All subjects were male (mean age 60 ± 5 years) including 25% with diabetes mellitus. At 1-year follow-up, there was one serious adverse event possibly related to MGA. Safety endpoints including VEGF and Ang-1 plasma protein levels were within normal ranges in all subjects. The mean maximal walking time increased from baseline to 1 year and the index limb ABI was unchanged, indicating no safety concerns. MGA, an autologous, transduced, cell-based therapy was well tolerated and safe in this Phase I study. Further evaluation is warranted in randomized human studies. Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT00390767. [ABSTRACT FROM AUTHOR]

Published
2016
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30. Defining the Optimal Degree of Heparin Anticoagulation for Peripheral Vascular Interventions

Author

Kasapis, Christos, primary, Gurm, Hitinder S., additional, Chetcuti, Stanley J., additional, Munir, Khan, additional, Luciano, Ann, additional, Smith, Dean, additional, Aronow, Herbert D., additional, Kassab, Elias H., additional, Knox, Michael F., additional, Moscucci, Mauro, additional, Share, David, additional, and Grossman, P. Michael, additional

Published
2010
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37. Myocardial Proinflammatory Cytokine Expression and Left Ventricular Remodeling in Patients With Chronic Mitral Regurgitation

Author

Oral, Hakan, primary, Sivasubramanian, Natarajan, additional, Dyke, David B., additional, Mehta, Rajendra H., additional, Grossman, P. Michael, additional, Briesmiester, Kerri, additional, Fay, William P., additional, Pagani, Francis D., additional, Bolling, Steven F., additional, Mann, Douglas L., additional, and Starling, Mark R., additional

Published
2003
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38. Safety and efficacy of thrombectomy in patientsundergoing primary percutaneous coronaryintervention for Acute ST elevation MI: AMeta-Analysis of Randomized Controlled Trials.

Author

Tamhane, Umesh U., Chetcuti, Stanley, Hameed, Irfan, Grossman, P. Michael, Moscucci, Mauro, and Gurm, Hitinder S.

Subjects
PERCUTANEOUS cholecystostomy, MYOCARDIAL infarction, RANDOMIZED controlled trials, CORONARY disease, META-analysis
Abstract

Background: Clinical trials comparing thrombectomy devices with conventional percutaneous coronary interventions (PCI) in patients with acute ST elevation myocardial infarction (STEMI) have produced conflicting results. The objective of our study was to systematically evaluate currently available data comparing thrombectomy followed by PCI with conventional PCI alone in patients with acute STEMI. Methods: Seventeen randomized trials (n = 3,909 patients) of thrombectomy versus PCI were included in this meta-analysis. We calculated the summary odds ratios for mortality, stroke, post procedural myocardial blush grade (MBG), thrombolysis in myocardial infarction (TIMI) grade flow, and post procedural ST segment resolution (STR) using random-effects and fixed-effects models. Results: There was no difference in risk of 30-day mortality (44/1914 vs. 50/1907, OR 0.84, 95% CI 0.54-1.29, P = 0.42) among patients randomized to thrombectomy, compared with conventional PCI. Thrombectomy was associated with a significantly greater likelihood of TIMI 3 flow (1616/1826 vs. 1533/1806, OR 1.41, P = 0.007), MBG 3 (730/1526 vs. 486/1513, OR 2.42, P < 0.001), STR (923/1500 vs. 715/1494, OR 2.30, P < 0.001), and with a higher risk of stroke (14/1403 vs. 3/1413, OR 2.88, 95% CI 1.06-7.85, P = 0.04). Outcomes differed significantly between different device classes with a trend towards lower mortality with manual aspiration thrombectomy (MAT) (21/949 vs.36/953, OR 0.59, 95% CI 0.35-1.01, P = 0.05), whereas mechanical devices showed a trend towards higher mortality (20/416 vs.10/418, OR 2.07, 95% CI 0.95-4.48, P = 0.07). Conclusions: Thrombectomy devices appear to improve markers of myocardial perfusion in patients undergoing primary PCI, with no difference in overall 30-day mortality but an increased likelihood of stroke. The clinical benefits of thrombectomy appear to be influenced by the device type with a trend towards survival benefit with MAT and worsening outcome with mechanical devices. [ABSTRACT FROM AUTHOR]

Published
2010
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40. Surgical Explantation of Transcatheter Aortic Valve Bioprostheses: A Statewide Experience.

Author

Brescia, Alexander A., Deeb, G. Michael, Sang, Stephane Leung Wai, Tanaka, Daizo, Grossman, P. Michael, Sukul, Devraj, He, Chang, Theurer, Patricia F., Clark, Melissa, Shannon, Francis L., Chetcuti, Stanley J., and Fukuhara, Shinichi

Abstract

Supplemental Digital Content is available in the text. Background: Despite the rapid adoption of transcatheter aortic valve replacement (TAVR) since its initial approval in 2011, the frequency and outcomes of surgical explantation of TAVR devices (TAVR-explant) is poorly understood. Methods: Patients undergoing TAVR-explant between January 2012 and June 2020 at 33 hospitals in Michigan were identified in the Society of Thoracic Surgeons Database and linked to index TAVR data from the Transcatheter Valve Therapy Registry through a statewide quality collaborative. The primary outcome was operative mortality. Indications for TAVR-explant, contraindications to redo TAVR, operative data, and outcomes were collected from Society of Thoracic Surgeons and Transcatheter Valve Therapy databases. Baseline Society of Thoracic Surgeons Predicted Risk of Mortality was compared between index TAVR and TAVR-explant. Results: Twenty-four surgeons at 12 hospitals performed TAVR-explants in 46 patients (median age, 73). The frequency of TAVR-explant was 0.4%, and the number of explants increased annually. Median time to TAVR-explant was 139 days and among known device types explanted, most were self-expanding valves (29/41, 71%). Common indications for TAVR-explant were procedure-related failure (35%), paravalvular leak (28%), and need for other cardiac surgery (26%). Contraindications to redo TAVR included need for other cardiac surgery (28%), unsuitable noncoronary anatomy (13%), coronary obstruction (11%), and endocarditis (11%). Overall, 65% (30/46) of patients underwent concomitant procedures, including aortic repair/replacement in 33% (n=15), mitral surgery in 22% (n=10), and coronary artery bypass grafting in 16% (n=7). The median Society of Thoracic Surgeons Predicted Risk of Mortality was 4.2% at index TAVR and 9.3% at TAVR-explant (P =0.001). Operative mortality was 20% (9/46) and 76% (35/46) of patients had in-hospital complications. Of patients alive at discharge, 37% (17/37) were discharged home and overall 3-month survival was 73±14%. Conclusions: TAVR-explant is rare but increasing, and its clinical impact is substantial. As the utilization of TAVR expands into younger and lower-risk patients, providers should consider the potential for future TAVR-explant during selection of an initial valve strategy. [ABSTRACT FROM AUTHOR]

Published
2021
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41. Safety of Contemporary Percutaneous Peripheral Arterial Interventions in the Elderly Insights From the BMC2 PVI (Blue Cross Blue Shield of Michigan Cardiovascular Consortium Peripheral Vascular Intervention) Registry

Author

Plaisance, Benjamin R., Munir, Khan, Share, David A., Mansour, M. Ashraf, Fox, James M., Bove, Paul G., Riba, Arthur L., Chetcuti, Stanley J., Gurm, Hitinder S., and Grossman, P. Michael

Subjects
peripheral vascular intervention, outcomes, peripheral artery disease, elderly
Abstract

ObjectivesThis study sought to evaluate the effect of age on procedure type, periprocedural management, and in-hospital outcomes of patients undergoing lower-extremity (LE) peripheral vascular intervention (PVI).BackgroundSurgical therapy of peripheral arterial disease is associated with significant morbidity and mortality in the elderly. There are limited data related to the influence of advanced age on the outcome of patients undergoing percutaneous LE PVI.MethodsClinical presentation, comorbidities, and in-hospital outcomes of patients undergoing LE PVI in a multicenter, multidisciplinary registry were compared between 3 age groups

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42. Impact of Sex on Morbidity and Mortality Rates After Lower Extremity Interventions for Peripheral Arterial Disease Observations From the Blue Cross Blue Shield of Michigan Cardiovascular Consortium

Author

Jackson, Elizabeth A., Munir, Khan, Schreiber, Theodore, Rubin, Jeffrey R., Cuff, Robert, Gallagher, Katherine A., Henke, Peter K., Gurm, Hitinder S., and Grossman, P. Michael

Subjects
peripheral vascular disease, sex, peripheral arterial intervention
Abstract

ObjectivesThis study sought to examine sex-related differences in outcomes related to peripheral vascular intervention (PVI) procedures.BackgroundPercutaneous PVI is frequently performed for the treatment of peripheral arterial disease (PAD). However, little is known about sex-related differences related to PVI procedures.MethodsWe assessed the impact of sex among 12,379 patients (41% female) who underwent lower extremity (LE)-PVI from 2004 to 2009 at 16 hospitals participating in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium PVI registry. Multivariate propensity-matched analyses were performed to adjust for differences in baseline characteristics, procedural indications, and comorbidities on the basis of sex.ResultsCompared with men, women were older and have multilevel disease and critical limb ischemia. In a propensity-matched analysis, female sex was associated with a higher rate of vascular complications, transfusions, and embolism. No differences were observed for in-hospital death, myocardial infarction, or stroke or transient ischemic attack. Technical success was more commonly achieved in women (91.2% vs. 89.1%, p = 0.014), but because of a higher complication rate, the overall procedural success rates were similar in men and women (79.7% vs. 81.6%, p = 0.08).ConclusionsWomen represent a significant proportion of patients undergoing LE-PVI, have a more severe and complex disease process, and are at increased risk for adverse outcomes. Despite higher complications rates, women had similar procedural success compared with men, making PVI an effective treatment strategy among women with LE-PAD.

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43. Percutaneous Coronary Intervention Complications and Guide Catheter Size Bigger Is Not Better

Author

Grossman, P. Michael, Gurm, Hitinder S., McNamara, Richard, LaLonde, Thomas, Changezi, Hameem, Share, David, Smith, Dean E., Chetcuti, Stanley J., and Moscucci, Mauro

Subjects
coronary intervention complications, coronary guide catheter size, percutaneous coronary intervention, coronary intervention outcomes
Abstract

ObjectivesWe evaluated the association between guiding catheter size and complications of percutaneous coronary intervention (PCI).BackgroundThe association between guiding catheter size and complications of PCI in contemporary practice remains controversial.MethodsProcedure and outcome variables from 103,070 consecutive patients that underwent PCI with 6-F (n = 64,335), 7-F (n = 32,676), and 8-F (n = 6,059) guide catheters were compared.ResultsCompared with 6-F guides, PCIs performed with 7- and 8-F guides were associated with incrementally more contrast agent use, and more post-PCI complications including contrast-induced nephropathy, vascular access site complications, bleeding, transfusion, major adverse cardiac event, and death. After multivariate analysis, the use of larger guides were associated with a higher risk of contrast-induced nephropathy (7-F odds ratio [OR]: 1.18, p = 0.0004; 8-F OR: 1.44, p < 0.0001), vascular complications (7-F OR: 1.19, p = 0.0002, 8-F OR: 1.68, p < 0.0001), decline in hemoglobin >3 g/dl (7-F OR: 1.12, p < 0.0001, 8-F OR: 1.72, p < 0.0001), and post-procedure blood transfusion (7-F OR: 1.08, p = 0.03; 8-F OR: 1.80, p < 0.0001), whereas major adverse cardiac events (7-F OR: 1.06, p = 0.13; 8-F OR: 1.37, p < 0.0001) and in-hospital mortality (7-F OR: 1.11, p = 0.13; 8-F OR: 1.34, p = 0.03) were increased with 8-F but not 7-F guides.ConclusionsCompared with 6-F guides, PCIs performed with 7- and 8-F guides were associated with more contrast medium use, renal complications, bleeding, vascular access site complications, greater need for post-procedure transfusion, and 8-F guides with increased nephropathy requiring dialysis, in-hospital major adverse cardiac events, and mortality. These data suggest that selection of smaller guide catheters may result in improved clinical outcome in patients undergoing contemporary PCI.

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44. Transcatheter Aortic Valve Replacement for Left Ventricular Assist Device-Related Aortic Regurgitation: The Michigan Medicine Experience.

Author

Gondi KT, Tam MC, Chetcuti SJ, Pagani FD, Grossman PM, Deeb GM, Menees DP, Haft JW, Patel HJ, Aaronson KD, and Sukul D

Abstract

Background: Aortic regurgitation (AR) is common and detrimental in patients with left ventricular assist devices (LVADs). Off-label use of transcatheter aortic valve replacement (TAVR) has emerged as a potential treatment option. Further data are required regarding the feasibility and outcomes of TAVR to treat AR in LVAD recipients., Methods: A retrospective review of all patients with LVADs who underwent TAVR for the treatment of AR at a single center was performed. All echocardiograms were independently reviewed to ensure accuracy., Results: Eleven patients with continuous-flow LVADs underwent TAVR for AR. All patients had moderate or severe AR with New York Heart Association (NYHA) class III and IV symptoms. Implantation of more than 1 valve was required in 4 (36.3%) patients; 1 patient died during the procedure because of valve migration into the left ventricle and 1 patient died in-hospital after TAVR. Of 9 (81.8%) patients discharged alive, 8 (72.7%) were alive at 12 months and all survivors had improvement in AR severity, natriuretic peptide levels, left ventricle end-diastolic diameter, and NYHA class. Five (62.5%) survivors had a large improvement (>20 points) in the Kansas City Cardiomyopathy Questionnaire score at 1 year. One survivor experienced heart failure, requiring hospitalization, within 1 year., Conclusions: In this single-center series, TAVR for the treatment of AR in patients with LVADs is technically challenging but feasible in select patients and may produce durable improvements in AR severity, functional status, and quality of life.

Published
2022
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45. Association of Anemia With Outcomes in Patients Undergoing Percutaneous Peripheral Vascular Intervention: Insights From the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2 VIC).

Author

Ambulgekar NV, Grey SF, Rosman HS, Othman H, Davis TP, Nypaver TJ, Schreiber T, Yamasaki H, Lalonde TA, Henke PK, Gurm HS, Mehta RH, and Grossman PM

Subjects
Aged, Blue Cross Blue Shield Insurance Plans statistics & numerical data, Comorbidity, Female, Humans, Male, Michigan epidemiology, Middle Aged, Outcome and Process Assessment, Health Care, Postoperative Complications diagnosis, Risk Assessment, Risk Factors, Anemia diagnosis, Anemia epidemiology, Peripheral Arterial Disease epidemiology, Peripheral Arterial Disease surgery, Postoperative Complications epidemiology, Vascular Surgical Procedures adverse effects, Vascular Surgical Procedures methods, Vascular Surgical Procedures statistics & numerical data
Abstract

Objectives: To evaluate the clinical features and outcomes of patients with anemia undergoing percutaneous peripheral vascular intervention (PVI) in a contemporary registry., Methods: We evaluated the differences in the clinical features and outcomes of patients with and without anemia undergoing PVI in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2 VIC) registry. Anemia was defined using World Health Organization criteria., Results: Baseline anemia was present in 42.3% of 15,683 patients undergoing PVI. Compared to patients without anemia, those with anemia were older (mean age, 67 years vs 71 years), were more often black (16% vs 29%), and had higher comorbidities. Anemic patients were twice as likely to present with acute limb ischemia (5% vs 11%) and undergo urgent PVI (6% vs 15%) or below-the-knee PVI (18% vs 35%). Many in-hospital adverse events were higher in anemic patients. In a propensity-matched cohort, any adverse outcome (3.4% vs 8.4%; odds ratio [OR], 2.58; 95% confidence interval [CI], 1.94-3.42) or major cardiovascular event, defined as death, myocardial infarction, stroke, or amputation (1.1% vs 3.2%; OR, 2.96; 95% CI, 1.83-4.79) was more likely in anemic patients. Of all adverse events, the highest odds were observed for post-PVI transfusions and amputations in anemic patients. Multivariable logistic regression showed that baseline hemoglobin (1 g/dL below the normal value) was associated with greater risk of any adverse event (OR, 1.57; 95% CI, 1.47-1.68)., Conclusion: The prevalence of anemia was high among PVI patients and was associated with significantly greater likelihood of amputation, any adverse event, and major cardiovascular events. Whether preprocedure correction of anemia has the potential to decrease post-PVI adverse events remains to be studied.

Published
2018

46. Cardiac-specific norepinephrine mass transport and its relationship to left ventricular size and systolic performance.

Author

Grossman PM, Linares OA, Supiano MA, Oral H, Mehta RH, and Starling MR

Subjects
Aged, Biological Transport, Cardiac Catheterization, Chronic Disease, Female, Heart Ventricles, Humans, Male, Middle Aged, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency metabolism, Motion Pictures, Myocardial Contraction, Norepinephrine blood, Radiography, Stroke Volume, Mitral Valve Insufficiency pathology, Mitral Valve Insufficiency physiopathology, Models, Cardiovascular, Myocardium metabolism, Myocardium pathology, Norepinephrine pharmacokinetics
Abstract

Objectives of this study were to develop a technique for quantifying cardiac-specific norepinephrine (NE) mass transport and determine whether cardiac NE kinetic modeling parameters were related to physiological variables of left ventricular (LV) size and systolic performance in nine patients with chronic mitral regurgitation. Biplane contrast cineventriculograms were used to determine LV size and ejection fraction (EF), micromanometer LV pressures and radionuclide LV volumes from a range of loading conditions to calculate LV end-systolic elastance, and [(3)H]NE infusions with LV and coronary sinus sampling for [(3)H]NE and endogenous NE during and after termination of infusions to model NE mass transport. Total NE release rate into cardiac interstitial fluid (M(IF)(R)) averaged 859 +/- 214 and NE released de novo into cardiac interstitial fluid (M(IF)(u,r,en)) averaged 546 +/- 174 pmol/min. Both M(IF)(R) and M(IF)(u,r,en)correlated directly with LV end-systolic volume (r = 0.84, P = 0.005; r = 0.86, P = 0.003); inversely with LV EFs (r = -0.75, P = 0.02; r = -0.81, P = 0.008); and inversely with LV end-systolic elastance values, optimally fit by a nonlinear function (r = 0.89, P = 0.04; r = 0.96, P = 0.01). We conclude that total and newly released NE into interstitial fluid of the heart, determined by regional mass transport kinetic model, are specific measures of regional cardiac-specific sympathetic nervous system activity and are strongly related to measures of LV size and systolic performance. These data support the concept that this new model of organ-specific NE kinetics has physiological relevance.

Published
2004
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