Objective: In the present study, we aimed to evaluate in detail the late outcomes of the overall endovascular cohort of the PARADE study, with a focus on factors that could influence such outcomes as these may provide useful insights for patients and clinicians alike. Methods: Between January 2010 and December 2023 patients with nonacute elective popliteal artery aneurysms undergoing endovascular exclusion with the Viabahn stent graft were included in a multicenter retrospective cohort study (40 sites from 10 countries). A cut-off of 15 procedures was used to define a participating center as high volume (>15) or low volume (<15). Results: During the 14-year studied period, 326 patients were treated who met inclusion criteria for the present study. Patients were predominantly male (304, 93.3%) with a mean age of 74.6 ± 9.2 years. Most patients were asymptomatic (221 [67.8%]); 56 (17.2%) had intermittent claudication and 49 (15%) chronic limb-threatening ischemia. Acute technical success was not obtained in two cases (0.6%), owing to residual type Ia endoleak (one case), and residual type Ib endoleak (one case). Of these, one patient underwent an open conversion, whereas the other one was followed up because unfit for any type of reintervention. At 30 days, two patients died with an overall 30-day mortality rate of 0.6%. Both were not cardiovascular deaths related to interventions. In addition, 30-day rates of major adverse cardiovascular events, graft occlusion, and procedure-related reinterventions were 1.2%, 3.7%, and 5.2%, respectively. No patient underwent early major amputation. The 5-year Kaplan-Meier estimates of primary patency, secondary patency, freedom from reinterventions(s), and amputation-free survival were 65.8% (95% confidence interval [CI], 61.7%-71.9%), 84.9% (95% CI, 78.7%-89.1%), 70.5% (95% CI, 66.2%-74.8%), and 98.2% (95% CI, 96.4%-99.6%), respectively. Amputation-free survival was adversely affected by active smoking (P = .011), chronic kidney disease (P < .001), poor run-off status (P = .042), and low number of cases for each center (<15) (P = .011). Multivariate analysis reported an approaching significance for active smoking (hazard ratio, 3.460; 95% CI, 2.6-6.1; P = .051), and confirmed the association with chronic kidney disease (hazard ratio, 7.413; 95% CI, 5.4-9.3; P = .006). Conclusions: The findings from this study show that endovascular repair using the Viabahn stent graft may provide a feasible technical option for elective treatment of popliteal artery aneurysm. Some patient-related and procedure-related factors were identified, including chronic kidney disease, that were associated with higher rates of long-term complications.
Late outcomes of Viabahn self-expandable covered stents for the elective treatment of popliteal artery aneurysms / Troisi N, Bertagna G, Lepidi S, Berchiolli R, Badalamenti G, D'Oria M; Daniele Adami, Valentina Scarati, Marco Andreini, Raffaele Pulli, Walter Dorigo, Carlo Pratesi, Sara Speziali, Brigida Biancofiore, Franco Grego, Michele Antonello, Michele Piazza, Francesco Squizzato, Elda Chiara Colacchio, Maria Antonella Ruffino, Giorgio Prouse, Alessandro Robaldo, Stefano Bonardelli, Luca Bertoglio, Paolo Baggi, Apollonia Verrengia, Arnaldo Ippoliti, Fabio Massimo Oddi, Andrea Ascoli Marchetti, Luca Di Marzo, Wassim Mansour, Alessia Di Girolamo, Antonio Marzano, Drosos Kotelis, Christian Zielasek, Dimitrios D Papazoglou, Reinhold Perkmann, Marco D Pipitone, Maurizio Taurino, Pasqualino Sirignano, Elisa Romano, Massimo Lenti, Giacomo Isernia, Gioele Simonte, Gianluigi Fino, Gian F Veraldi, Luca Mezzetto, Domenico Angiletta, Sergio Zacà, Margot Ringold, Francesca Sodero, Georgios Pitoulias, Dimitrios A Chatzelas, Aaron Fargion, Luca Traina, Gladiol Zenunaj, Manar Khashram, Nusr Ghamri, Thomas M Lovelock, Hany Zayed, Ayman Hamdy, Lukla Biasi, Patel Sanjay, Sandro Lepidi, Mario D'Oria, Giovanni Badalamenti, Massimo G Ruggiero, Claudio Desantis, Federico Filippi, Manfredi Anzaldi, Andrea Siani, Federico Accrocca, Roberto Gabrielli, Stefano Bartoli, Massimiliano Martelli, Raimondo Micheli, Maria C Gugliotta, Nikolaos Bessias, Konstantinos Roditis, Paraskevi Tsiantoula, Theofanis T Papas, Konstantinos G Seretis, Marco V Usai, Yamume Tshomba, Marco Natola, Lucia Scurto, Grigorios Korosoglou, Christoph Schoefthaler, Amila Jehn, Athanasios Saratzis, Robert Davies, Gabriele Maritati, Shantonu Kumar Ghosh, Konstantinos P Donas, Apostolos G Pitoulias, Konstantinos Avranas, Gennaro Bafile, Eugenio Martelli, Eduardo Cavallo, Roberto Caronno, Aldo Alberti, Pietro Volpe, Mafalda Massara, Antonino Alberti, Gian F Fadda, Sara Zappadu, Giovanni B Torsello, Giuseppe Asciutto, Erika Lilja, Pablo Del Canto Peruyera. - In: JOURNAL OF VASCULAR SURGERY. - ISSN 0741-5214. - STAMPA. - (2025), pp. 1658-1668.
Late outcomes of Viabahn self-expandable covered stents for the elective treatment of popliteal artery aneurysms
Raffaele Pulli;Walter Dorigo;Carlo Pratesi;Sara Speziali;Brigida Biancofiore;
2025
Abstract
Objective: In the present study, we aimed to evaluate in detail the late outcomes of the overall endovascular cohort of the PARADE study, with a focus on factors that could influence such outcomes as these may provide useful insights for patients and clinicians alike. Methods: Between January 2010 and December 2023 patients with nonacute elective popliteal artery aneurysms undergoing endovascular exclusion with the Viabahn stent graft were included in a multicenter retrospective cohort study (40 sites from 10 countries). A cut-off of 15 procedures was used to define a participating center as high volume (>15) or low volume (<15). Results: During the 14-year studied period, 326 patients were treated who met inclusion criteria for the present study. Patients were predominantly male (304, 93.3%) with a mean age of 74.6 ± 9.2 years. Most patients were asymptomatic (221 [67.8%]); 56 (17.2%) had intermittent claudication and 49 (15%) chronic limb-threatening ischemia. Acute technical success was not obtained in two cases (0.6%), owing to residual type Ia endoleak (one case), and residual type Ib endoleak (one case). Of these, one patient underwent an open conversion, whereas the other one was followed up because unfit for any type of reintervention. At 30 days, two patients died with an overall 30-day mortality rate of 0.6%. Both were not cardiovascular deaths related to interventions. In addition, 30-day rates of major adverse cardiovascular events, graft occlusion, and procedure-related reinterventions were 1.2%, 3.7%, and 5.2%, respectively. No patient underwent early major amputation. The 5-year Kaplan-Meier estimates of primary patency, secondary patency, freedom from reinterventions(s), and amputation-free survival were 65.8% (95% confidence interval [CI], 61.7%-71.9%), 84.9% (95% CI, 78.7%-89.1%), 70.5% (95% CI, 66.2%-74.8%), and 98.2% (95% CI, 96.4%-99.6%), respectively. Amputation-free survival was adversely affected by active smoking (P = .011), chronic kidney disease (P < .001), poor run-off status (P = .042), and low number of cases for each center (<15) (P = .011). Multivariate analysis reported an approaching significance for active smoking (hazard ratio, 3.460; 95% CI, 2.6-6.1; P = .051), and confirmed the association with chronic kidney disease (hazard ratio, 7.413; 95% CI, 5.4-9.3; P = .006). Conclusions: The findings from this study show that endovascular repair using the Viabahn stent graft may provide a feasible technical option for elective treatment of popliteal artery aneurysm. Some patient-related and procedure-related factors were identified, including chronic kidney disease, that were associated with higher rates of long-term complications.
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