Browsing by Author "Dake, Michael D."

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    The Clinical Rationale for the Sentry Bioconvertible Inferior Vena Cava Filter for the Prevention of Pulmonary Embolism
    (Hindawi, 2019-05-26) Dake, Michael D.; Ansel, Gary M.; Johnson, Matthew S.; Mendes, Robert; Smouse, H. Bob; Vascular & Interventional Radiology, IU School of Medicine
    The Sentry inferior vena cava (IVC) filter is designed to provide temporary protection against pulmonary embolism (PE) during transient high-risk periods and then to bioconvert after 60 days after implantation. At the time of bioconversion, the device's nitinol arms retract from the filtering position into the caval wall. Subsequently, the stable stent-like nitinol frame is endothelialized. The Sentry bioconvertible IVC filter has been evaluated in a multicenter investigational-device-exemption pivotal trial (NCT01975090) of 129 patients with documented deep vein thrombosis (DVT) or PE, or at temporary risk of developing DVT or PE, and with contraindications to anticoagulation. Successful filter conversion was observed in 95.7% of patients at 6 months (110/115) and 96.4% at 12 months (106/110). Through 12 months, there were no cases of symptomatic PE. The rationale for development of the Sentry bioconvertible device includes the following considerations: (1) the period of highest risk of PE for the vast majority of patients occurs within the first 60 days after an index event, with most of the PEs occurring in the first 30 days; (2) the design of retrievable IVC filters to support their removal after a transitory high-PE-risk period has, in practice, been associated with insecure filter dynamics and time-dependent complications including tilting, fracture, embolization, migration, and IVC perforation; (3) most retrievable IVC filters are placed for temporary protection, but for a variety of reasons they are not removed in any more than half of implanted patients, and when removal is attempted, the procedure is not always successful even with advanced techniques; and (4) analysis of Medicare hospital data suggests that payment for the retrieval procedure does not routinely compensate for expense. The Sentry device is not intended for removal after bioconversion. In initial clinical use, complications have been limited. Long-term results for the Sentry bioconvertible IVC filter are anticipated soon.
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    One-Year Analysis of the Prospective Multicenter SENTRY Clinical Trial: Safety and Effectiveness of the Novate Sentry Bioconvertible Inferior Vena Cava Filter
    (Elsevier, 2018-10-01) Dake, Michael D.; Murphy, Timothy P.; Krämer, Albrecht H.; Darcy, Michael D.; Sewall, Luke E.; Curi, Michael A.; Johnson, Matthew S.; Arena, Frank; Swischuk, James L.; Ansel, Gary M.; Silver, Mitchell J.; Saddekni, Souheil; Brower, Jayson S.; Mendes, Robert; Dake, Michael D.; Feezor, Robert; Kalva, Sanjeeva; Kies, Darren; Bosiers, Marc; Ziegler, Werner; Farber, Mark; Paolini, David; Spillane, Robert; Jones, Steven; Peeters, Patrick; Radiology and Imaging Sciences, School of Medicine
    Purpose To prospectively assess the Sentry bioconvertible inferior vena cava (IVC) filter in patients requiring temporary protection against pulmonary embolism (PE). Materials and Methods At 23 sites, 129 patients with documented deep vein thrombosis (DVT) or PE, or at temporary risk of developing DVT or PE, unable to use anticoagulation were enrolled. The primary end point was clinical success, including successful filter deployment, freedom from new symptomatic PE through 60 days before filter bioconversion, and 6-month freedom from filter-related complications. Patients were monitored by means of radiography, computerized tomography (CT), and CT venography to assess filtering configuration through 60 days, filter bioconversion, and incidence of PE and filter-related complications through 12 months. Results Clinical success was achieved in 111 of 114 evaluable patients (97.4%, 95% confidence interval [CI] 92.5%–99.1%). The rate of freedom from new symptomatic PE through 60 days was 100% (n = 129, 95% CI 97.1%–100.0%), and there were no cases of PE through 12 months for either therapeutic or prophylactic indications. Two patients (1.6%) developed symptomatic caval thrombosis during the first month; neither experienced recurrence after successful interventions. There was no filter tilting, migration, embolization, fracture, or caval perforation by the filter, and no filter-related death through 12 months. Filter bioconversion was successful for 95.7% (110/115) at 6 months and for 96.4% (106/110) at 12 months. Conclusions The Sentry IVC filter provided safe and effective protection against PE, with a high rate of intended bioconversion and a low rate of device-related complications, through 12 months of imaging-intense follow-up.
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    Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia
    (Massachusetts Medical Society, 2022-11-07) Farber, Alik; Menard, Matthew T.; Conte, Michael S.; Kaufman, John A.; Powell, Richard J.; Choudhry, Niteesh K.; Hamza, Taye H.; Assmann, Susan F.; Creager, Mark A.; Cziraky, Mark J.; Dake, Michael D.; Jaff, Michael R.; Reid, Diane; Siami, Flora S.; Sopko, George; White, Christopher J.; van Over, Max; Strong, Michael B.; Villarreal , Maria F.; McKean, Michelle; Azene, Ezana; Azarbal, Amir; Barleben, Andrew; Chew, David K.; Clavijo, Leonardo C.; Douville, Yvan; Findeiss, Laura; Garg, Nitin; Gasper, Warren; Giles, Kristina A.; Goodney, Philip P.; Hawkins, Beau M.; Herman, Christine R.; Kalish, Jeffrey A.; Koopmann, Matthew C.; Laskowski, Igor A.; Mena-Hurtado, Carlos; Motaganahalli, Raghu; Rowe, Vincent L.; Schanzer, Andres; Schneider, Peter A.; Siracuse, Jeffrey J.; Venermo, Maarit; Rosenfield, Kenneth; BEST-CLI Investigators; Surgery, School of Medicine
    BACKGROUND Patients with chronic limb-threatening ischemia (CLTI) require revascularization to improve limb perfusion and thereby limit the risk of amputation. It is uncertain whether an initial strategy of endovascular therapy or surgical revascularization for CLTI is superior for improving limb outcomes. METHODS In this international, randomized trial, we enrolled 1830 patients with CLTI and infrainguinal peripheral artery disease in two parallel-cohort trials. Patients who had a single segment of great saphenous vein that could be used for surgery were assigned to cohort 1. Patients who needed an alternative bypass conduit were assigned to cohort 2. The primary outcome was a composite of a major adverse limb event — which was defined as amputation above the ankle or a major limb reintervention (a new bypass graft or graft revision, thrombectomy, or thrombolysis) — or death from any cause. RESULTS In cohort 1, after a median follow-up of 2.7 years, a primary-outcome event occurred in 302 of 709 patients (42.6%) in the surgical group and in 408 of 711 patients (57.4%) in the endovascular group (hazard ratio, 0.68; 95% confidence interval [CI], 0.59 to 0.79; P<0.001). In cohort 2, a primary-outcome event occurred in 83 of 194 patients (42.8%) in the surgical group and in 95 of 199 patients (47.7%) in the endovascular group (hazard ratio, 0.79; 95% CI, 0.58 to 1.06; P=0.12) after a median follow-up of 1.6 years. The incidence of adverse events was similar in the two groups in the two cohorts. CONCLUSIONS Among patients with CLTI who had an adequate great saphenous vein for surgical revascularization (cohort 1), the incidence of a major adverse limb event or death was significantly lower in the surgical group than in the endovascular group. Among the patients who lacked an adequate saphenous vein conduit (cohort 2), the outcomes in the two groups were similar. (Funded by the National Heart, Lung, and Blood Institute; BEST-CLI ClinicalTrials.gov number, NCT02060630.)