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Author

Holden, Andrew

Published
2005

14. Editor's Choice -- European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Asymptomatic Lower Limb Peripheral Arterial Disease and Intermittent Claudication

Author

Nordanstig, Joakim, Behrendt, Christian-Alexander, Baumgartner, Iris, Belch, Jill, Bäck, Maria, Fitridge, Robert, Hinchliffe, Robert, Lejay, Anne, Mills, Joseph L., Rother, Ulrich, Sigvant, Birgitta, Spanos, Konstantinos, Szeberin, Zoltán, van de Water, Willemien, Antoniou, George A., Björck, Martin, Gonçalves, Frederico Bastos, Coscas, Raphael, Dias, Nuno V., Van Herzeele, Isabelle, Lepidi, Sandro, Mees, Barend M.E., Resch, Timothy A., Ricco, Jean-Baptiste, Trimarchi, Santi, Twine, Christopher P., Tulamo, Riikka, Wanhainen, Anders, Boyle, Jonathan R., Brodmann, Marianne, Dardik, Alan, Dick, Florian, Goëffic, Yann, Holden, Andrew, Kakkos, Stavros K., Kolh, Phillipe, and McDermott, Mary M.

Published
2024
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16. Update on paclitaxel for femoral-popliteal occlusive disease in the 15 months following a summary level meta-analysis demonstrated increased risk of late mortality and dose response to paclitaxel

Author

Schneider, Peter A, Varcoe, Ramon L, Secemsky, Eric, Schermerhorn, Marc, and Holden, Andrew

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Cancer, Patient Safety, Cardiovascular, Clinical Research, Clinical Trials and Supportive Activities, Good Health and Well Being, Angioplasty, Balloon, Arterial Occlusive Diseases, Coated Materials, Biocompatible, Dose-Response Relationship, Drug, Femoral Artery, Follow-Up Studies, Global Health, Humans, Paclitaxel, Popliteal Artery, Survival Rate, Time Factors, Tubulin Modulators, Drug-coated balloon, Drug-eluting stent, Femoral-popliteal occlusive disease, Medical and Health Sciences, Cardiovascular System & Hematology, Cardiovascular medicine and haematology, Clinical sciences
Abstract

BackgroundPeripheral vascular devices (stents and balloons) coated with paclitaxel were developed to address suboptimal outcomes associated with percutaneous revascularization procedures of the femoral-popliteal arteries. In randomized controlled trials (RCT), paclitaxel-coated devices (PCD) provided increased long-term patency and a decreased need for repeat revascularization procedures compared with uncoated devices. This finding resulted in the adoption of their use for endovascular lower extremity revascularization procedures. However, in late 2018 a study-level meta-analysis showed increased all-cause mortality at 2 years or more after the procedure in patients treated with PCDs. This review examines the subsequent data evaluation following the publication of the meta-analysis.MethodsWe review the published responses of physicians, regulatory agencies, and patient advocates during 15-month period after the meta-analysis. We present the additional data gathered from RCTs that comprised the meta-analysis and safety outcomes from large insurance databases in both the United States and Europe.ResultsImmediately after the publication of the meta-analysis, concern for patient safety resulted in less PCD use, the suspension of large RCTs evaluating their use, and the publication of a letter from the U.S. Food and Drug Administration informing physicians that there was uncertainty in the benefit-risk profile of these devices for indicated patients and that the potential risk should be assessed before the use of PCDs. Review of the meta-analysis found that a mortality signal was present, but criticisms included that the evaluation was performed on study-level, not patient-level data, and the studies in the analysis were heterogenous in device type, paclitaxel doses, and patient characteristics. Further, the studies were not designed to be pooled nor were they powered for evaluating long-term safety. Clinical characteristics associated with a drug effect or causal relationship were also absent. Specifically, there was no dose response, no clustering of causes of death, and a lack of signal consistency across geographic regions. As more long-term data became available in the RCTs the strength of the mortality signal diminished and analysis of real-world use in large insurance databases, showed that there was no significant increase in all-cause mortality associated with PCD use.ConclusionsThe available data do not provide definitive proof for increased mortality with PCD use. A key observation is that trial design improvements will be necessary to better evaluate the risk-benefit profile of PCDs.

Published
2021

20. Evaluation of an Infrapopliteal Drug-Eluting Resorbable Scaffold: Design Methodology for the LIFE-BTK Randomized Controlled Trial

Author

Varcoe, Ramon L., Parikh, Sahil A., DeRubertis, Brian G., Jones-McMeans, Jennifer M., Teraphongphom, Nutte Tarn, Wang, Jin, Kolluri, Raghu, Weinberg, Ido, Holden, Andrew H., Garcia-Garcia, Hector M., Kum, Steven W.C., Bonaca, Marc P., Bajakian, Danielle R., Garcia, Lawrence A., Krishnan, Prakash, Armstrong, Ehrin, Shishehbor, Mehdi H., Rundback, John, and Metzger, D. Chris

Published
2023
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25. Opera avanti a Dio! : religion and opera in liberal Italy from Unification to the First World War

Author

Holden, Andrew James and Eichner, Barbara

Subjects
945
Abstract

Against the background of the evolving confrontation between the Catholic Church and the new state, religion in opera in Liberal Italy took on a new significance, both in new works and the revival of operas from earlier in the nineteenth century. Focusing on repertoire reflecting Catholic settings and theology, this thesis offers a fresh argument about the consistency of religious tropes and their significance in the political, cultural and social trends of Liberal Italy. It sets the treatment and reception of religious themes in opera in three contrasting urban contexts - the fascination with the supernatural in the positivist, intellectual centre of Turin, the culture war between competing visions of society and the purpose of art in Venice, and the confrontation between Papal Rome and the growing new capital city. Two thematic chapters consider how the adaptation of source texts in this period tended to augment religious themes, often emphasising conventional and orthodox religious views, and examine a series of musical and dramaturgical examples of the operatic markers of religion, which represented religious tropes including liturgical scenes, prayers and visions of the celestial and infernal, to suggest how little these changed in comparison to the broader musical style in this period. It challenges existing assumptions in several ways, including highlighting the continuing role of censorship until the mid-1890s. However, the Catholic social revival and the realignment of clerical and conservative political forces during the 1890s supported a broader, positive reading of religious tropes in opera. Analysis of archival sources, the daily and Catholic press, show that by 1900, even Puccini's Tosca, supposedly the most anticlerical opera according to many musicologists, was read sympathetically by Catholic opinion. Before the First World War, the arrival on Italian stages of Wagner's Parsifal saw liberal and Catholic opinion compete to praise its specifically Catholic qualities and Italian heritage.

Published
2019
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27. Editor's Choice – PRINciples of optimal antithrombotiC therapy and coagulation managEment during elective fenestrated and branched EndovaScular aortic repairS (PRINCE2SS): An International Expert Based Delphi Consensus Study

Author

Abisi, Said, Adam, Donald, Antonello, Michele, Austermann, Martin, Beck, Adam W., Berard, Xavier, Bisdas, Theodosios, Böckler, Dittmar, Budtz-Lilly, Jacob, Cheng, Stephen W.K., Czerny, Martin, DeMartino, Randall, Dias, Nuno, Donas, Konstantinos P., Eagleton, Matthew J., Farber, Mark A., Fargion, Aaron Thomas, Ferreira, Marcelo, Forbes, Thomas L., Gargiulo, Mauro, Gasper, Warren J., Jakimowicz, Tomasz, Haulon, Stéphan, Hockley, Joseph A., Holden, Andrew, Holt, Peter, Kahlberg, Andrea, Khashram, Manar, Kotelis, Drosos, Lundberg, Göran, Maldonado, Thomas S., Mangialardi, Nicola, Mastracci, Tara M., Maurel, Blandine, Milner, Ross, Modarai, Bijan, Pannuccio, Giuseppe, Parlani, Gianbattista, Pratesi, Giovanni, Pulli, Raffaele, Qasabian, Raffi A., Reijnen, Michel M.P. J., Resh, Timothy, Riambau, Vincente, Settembre, Nicla, Schanzer, Andres, Schmidt, Andrej, Schneider, Darren, Schurink, Geert Willem H., Silingardi, Roberto, Sobocinski, Jonathan, Soler, Raphael, Sweet, Matthew P., Leong Tan, Glenn Wei, Tenorio, Emanuel R., Tielliu, Ignace F.J., Timaran, Carlos H., Tshomba, Yamume, Tsilimparis, Nikolaos, Van den Eynde, Wouter, Vasudevan, Thodur, Veraldi, Gian Franco, Verhagen, Hence JM., Verhoeven, Eric, Verzini, Fabio, Wanhainen, Anders, Zimmermann, Alexander, D’Oria, Mario, Bertoglio, Luca, Bignamini, Angelo Antonio, Mani, Kevin, Kölbel, Tilo, Oderich, Gustavo, Chiesa, Roberto, and Lepidi, Sandro

Published
2022
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30. Accounting for healthcare in the Newcastle Infirmary during the 19th century

Author

Holden, Andrew John

Subjects
362.1068
Abstract

Accounting played a critical role in the management of the Newcastle Infirmary during the 19th century. In a class-based society, the poor relied upon the generosity of the wealthy for their healthcare at a time when poverty itself was seen as a sin, an act against God. These wealthy donors established and maintained hospitals, such as the Newcastle Infirmary, and were responsible for the governance, management and admission of patients. Their aim was to be seen to use resources efficiently and to treat the "deserving poor" to restore them to productive members of society. Throughout the century new buildings, medical advances and increasingly highly specialised staff had to be financed to cope with increasing demand. In the last quarter of the century, paid administrators were employed to manage the Infirmary as finance came less from the wealthy few and more from individual workers and separate charitable bodies. This thesis demonstrates how the management of the Newcastle Infirmary used accounting as a moral practice to allow treatment for patients who were outside the rules, which were a guide to the admission and treatment of patients, and to justify expenditure on large capital projects on nothing more than acts of faith. In turn, accounting was used as a tool to hold managers accountable for their actions and as a vehicle for communicating that accountability to the changing providers of finance. This thesis adds to the literature on accounting within early voluntary hospitals by identifying the balance of contributions of costing systems to planning and decision making and the impact of finance on governance and holding managers accountable for their performance and the successful treatment of patients.

Published
2018

33. One Year Outcomes of an International Multicentre Prospective Cohort Study on the Gore Excluder Iliac Branch Endoprosthesis for Aorto-Iliac Aneurysms

Author

van der Veen, Daphne, Holewijn, Suzanne, van Sterkenburg, Steven M.M., Lardenoije, Jan-Willem H.P., Smeets, Luuk, Reijnen, Michel M.P.J., Bellosta, Raffaello, Attisani, Luca, Luzzani, Luca, Heyligers, Jan M.M., van Hees, Koen, Ficarelli, Ilaria, Ruotolo, Carlo, Gómez Palonés, Francisco J., Sala Almonacil, Vicente A., Mangialardi, Nicola, Ronchey, Sonia, Orrico, Matteo, Mosquera, Nilo J., Villardefrancos, Rosa, and Holden, Andrew

Published
2021
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37. Long-Term Follow-up of Subjects With Iliac Occlusive Disease Treated With the Viabahn VBX Balloon-Expandable Endoprosthesis.

Author

Holden, Andrew, Takele, Elleni, Hill, Andrew, Sakhuja, Rahul, Metzger, Christopher, Gray, Bruce H., and Cavadino, Alana

Abstract

Introduction: This physician-initiated study provides 5-year (i.e., long-term) treatment durability data from 3 top recruitment sites that participated in the prospective, multicenter, nonrandomized, single-arm VBX FLEX clinical study (ClinicalTrials.gov identifier: NCT02080871). It evaluates the long-term treatment durability of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX Stent-Graft) in the treatment of subjects with de novo or restenotic aortoiliac lesions. Materials and Methods: A total of 59 subjects with 94 treated lesions were enrolled at the 3 participating sites from the original 140 intent-to-treat subjects in the VBX FLEX study. The primary durability endpoint was long-term primary patency. Secondary long-term outcomes included freedom from target lesion revascularization (TLR), freedom from target vessel revascularization (TVR), as well as resting ankle-brachial index (ABI), Rutherford category, EuroQol 5 Dimensions, and Walking Impairment status. Results: Fifty-nine subjects participated and twenty-eight (47.5%) were available through the end of the study at 5-year follow-up (the median follow-up time was 6.6 years due to complications resulting from COVID-19 precautions). At 3 and 5 years, the Kaplan-Meier estimates for freedom from all-cause mortality were 94.5% and 81.7%, respectively. The Kaplan-Meier estimates for primary patency at 3 and 5 years were 94.0% and 89.5% (by lesion) and 91.7% and 84.4% (by subject). Primary assisted patency at 3 and 5 years were 93.3% and 93.3%. Kaplan-Meier estimate for freedom from TLR at 5 years was 89.1%. The majority of subjects were asymptomatic (Rutherford category 0) at 3 years (29/59; 72%), and at 5-year follow-up (18/28; 64%). The 5-year mean resting ankle-brachial index was 0.95±0.18, an improvement of 0.15±0.26 from the baseline (p<0.001). Quality of life measures also showed sustained improvement through long-term follow-up. Conclusion: The 5-year long-term follow-up data underscore the robustness and durability of the Viabahn Balloon-Expandable Endoprosthesis for treating aortoiliac occlusive disease. Clinical Impact: Durable improvement after endovascular treatment of iliac occlusive disease is clinically important because many of these patients are claudicants with significant life expectancy. This study is the first to evaluate the long-term outcomes in patients with iliac occlusive disease treated with the Viabahn VBX balloon-expandable endopirostheses. The study reports excellent long-term patency outcomes with prolonged clinical benefit. These durable results are likely to be an important consideration for clinicians undertaking iliac artery revascularization procedures. [ABSTRACT FROM AUTHOR]

Published
2025
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38. Shape memory polymer technology in peripheral vascular embolization.

Author

Holden, Andrew, Hill, Andrew A, and Buckley, Brendan T

Abstract

Objectives: Porous, radiolucent, shape memory polymer is a new technology available in discrete peripheral vascular embolization devices. Shape memory polymers can exist in two stable shapes; crimped for catheter delivery and expanded for vessel embolization. The expanded shape memory polymer in these new devices is hemostatic, and the porous polymeric scaffold has been shown to support tissue ingrowth and eventually bioabsorbs in preclinical animal studies. This report describes clinical experience with this novel material in vascular plug devices. Methods: a prospective, single-arm, safety study at a single center in New Zealand with longer term follow-up via retrospective imaging review. The study device was a pushable shape memory polymer vascular plug with a distal nitinol anchor coil and a proximal radiopaque marker. Results: Ten male patients were each implanted with a single shape memory polymer vascular plug. Three inferior mesenteric arteries and an accessory renal artery were embolized during endovascular aneurysm repair. An internal iliac artery was treated prior to the open surgical repair of aorto-iliac aneurysms. An internal iliac artery and a subclavian artery were embolized to treat/prophylactically address potential endoleaks. A profunda branch was embolized prior to tumor resection, and two testicular veins were embolized to treat varicoceles. Acute technical success of target vessel embolization was achieved in all implantation cases. Patients were followed for 30 days as part of the study, and no serious adverse events with a relationship to the study device occurred. No recurrent clinical symptoms attributable to treated vessel embolization or recanalization were documented. There was no evidence of recanalization on retrospective review of follow-up imaging through a mean of 22.2 months (range, <1–44 months) post-procedure. Conclusions: Shape memory polymer vascular embolization devices were safe and effective over the follow-up period of this small safety study. Further experience and longer term follow-up will assess further applicability. [ABSTRACT FROM AUTHOR]

Published
2024
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42. Balloon-Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease: 9-Month Results from the BOLSTER Multicenter Study

Author

Elmasri, Fakhir, Robinson, William, Beasley, Robert, Mego, David, Marica, Silviu, Bersin, Robert, Kujath, Scott, Razavi, Mahmood, Teßarek, Jörg, Schulte, Karl-Ludwig, Laird, John R., Zeller, Thomas, Holden, Andrew, Scheinert, Dierk, Moore, Erin, Mendes, Robert, Schmiedel, Rainer, Settlage, Richard, Lansky, Alexandra, and Jaff, Michael R.

Published
2019
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46. An International Expert-Based CONsensus on Indications and Techniques for aoRtic balloOn occLusion in the Management of Ruptured Abdominal Aortic Aneurysms (CONTROL-RAAA)

Author

D’Oria, Mario, primary, Lembo, Rosalba, additional, Hörer, Tal M., additional, Rasmussen, Todd, additional, Mani, Kevin, additional, Parlani, Gianbattista, additional, Ierardi, Anna Maria, additional, Veraldi, Gian Franco, additional, Melloni, Andrea, additional, Bonardelli, Stefano, additional, Lepidi, Sandro, additional, Bertoglio, Luca, additional, Antonello, Michele, additional, Mees, Barend, additional, Bath, Jonathan, additional, Goncalves, Frederico Bastos, additional, Beck, Adam W, additional, Bellmunt, Sergi, additional, Berard, Xavier, additional, Bose, Joseph Du, additional, Budtz-Lilly, Jacob, additional, Calvagna, Cristiano, additional, Czerny, Martin, additional, Dawson, David, additional, McGreevy, David T, additional, Greenberg, George, additional, Savlania, Ajay, additional, Davies, Mark G, additional, Dias, Nuno, additional, Farber, Mark A, additional, Fajer, Simone, additional, Ferreira, Marcelo, additional, Franchin, Marco, additional, Gallitto, Enrico, additional, Goldin, Ilya, additional, Jakimowicz, Tomasz, additional, van Herzeele, Isabelle, additional, Hockley, Joseph A, additional, Holden, Andrew, additional, Kahlberg, Andrea, additional, Charlton-Ouw, Kristofer M, additional, Khashram, Manar, additional, Kotelis, Drosos, additional, Giacomo, Isernia, additional, Maldonado, Thomas S, additional, Magee, Gregory, additional, Maurel, Blandine, additional, Mezzetto, Luca, additional, Milner, Ross, additional, Panuccio, Giuseppe, additional, Helmio, Paivi, additional, Pratesi, Giovanni, additional, Reijnen, Michel M P J, additional, Resch, Timothy, additional, Riambau, Vincente, additional, Starnes, Benjamin, additional, Settembre, Nicla, additional, Smeds, Matthew R., additional, Scali, Salvatore, additional, Psyllas, Anastasios, additional, Sobocinski, Jonathan, additional, Guliani, Sundeep, additional, Tan, Glenn Wei Leong, additional, Tinelli, Giovanni, additional, Tsilimparis, Nikolaos, additional, Trimarchi, Santi, additional, Vriens, Patrick, additional, Wahlgren, Carl, additional, Van den Eynde, Wouter, additional, Vasudevan, Thodur, additional, Verhagen, Hence JM, additional, Zacà, Sergio, additional, Troisi, Nicola, additional, Wanhainen, Anders, additional, Witheford, Miranda, additional, and Zimmermann, Alexander, additional

Published
2023
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47. European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Asymptomatic Lower Limb Peripheral Arterial Disease and Intermittent Claudication

Author

Nordanstig, Joakim, primary, Behrendt, Christian-Alexander, additional, Baumgartner, Iris, additional, Belch, Jill, additional, Bäck, Maria, additional, Fitridge, Robert, additional, Hinchliffe, Robert, additional, Lejay, Anne, additional, Mills, Joseph L., additional, Rother, Ulrich, additional, Sigvant, Birgitta, additional, Spanos, Konstantinos, additional, Szeberin, Zoltán, additional, van de Water, Willemien, additional, Antoniou, George A., additional, Björck, Martin, additional, Gonçalves, Frederico Bastos, additional, Coscas, Raphael, additional, Dias, Nuno V., additional, van Herzeele, Isabelle, additional, Lepidi, Sandro, additional, Mees, Barend M.E., additional, Resch, Timothy A., additional, Ricco, Jean-Baptiste, additional, Trimarchi, Santi, additional, Twine, Christopher P., additional, Tulamo, Riikka, additional, Wanhainen, Anders, additional, Boyle, Jonathan R., additional, Brodmann, Marianne, additional, Dardik, Alan, additional, Dick, Florian, additional, Goëffic, Yann, additional, Holden, Andrew, additional, Kakkos, Stavros, additional, Kolh, Phillipe, additional, and McDermott, Mary M., additional

Published
2023
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50. A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial

Author

Albrecht, Thomas, Ando, Kenji, Babaev, Anvar, Bacharach, Michael J, Bachinsky, William, Bajakian, Danielle, Beasley, Robert, Benenati, James, Benko, Andrew, Burket, Mark, Cardenas, Joseph, Das, Tony, De Martino, Randall, Deutschmann, Hannes, Dulas, Daniel, Feldman, Robert, Fugate, Mark, Garcia, Lawrence, Golzar, Jaafer, Gutta, Rao, Hall, Patrick, Hawkins, Stewart, Henao, Steve, Herdrich, Benjamin, Hirano, Keisuke, Holden, Andrew, Jaalouk, Safwan, Janzer, Sean, Kawasaki, Daizo, Keirse, Koen, Khatib, Yazan, Kichikawa, Kimihiko, Korngold, Ethan, Loewe, Christian, Lopez, Louis, Lui, Henry, Mano, Toshiaki, Mendes, Robert, Miyamoto, Akira, Müller-Hülsbeck, Stefan, Nakamura, Masato, O'Connor, David, Ohki, Takao, Park, James, Powell, Richard, Pratsos, Antonis, Prem, Jeffery, Rao, Vikram, Rashid, John, Rhee, Robert, Ricci, Jason, Scheinert, Dierk, Schroë, Herman, Schroeder, Henrik, Simon, Peter O, Jr., Singh, Gagan, Tan, Kongteng, Tolerico, Paul, Vasudevan, Thodur, Vermassen, Frank, Werner, Martin, Wiechmann, Bret, Yokoi, Hiroyoshi, Yokoi, Yoshiaki, Zeller, Thomas, Gray, William A, Soga, Yoshimitsu, Prem, Jeffery T, Popma, Jeffrey, Jaff, Michael R, and Diaz-Cartelle, Juan

Published
2018
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