Gemma Kay1, Elizabeth L Eby2, Benedict Brown3, Julie Lyon4, Simon Eggington3, Gayathri Kumar1, Elisabeth Fenwick1, M Rizwan Sohail5, David Jay Wright6. 1. a ICON Health Economics and Epidemiology , Abingdon , UK. 2. b Medtronic plc , Mounds View , MN , USA. 3. c Medtronic International Trading Sàrl , Tolochenaz , Switzerland. 4. d Medtronic, Ltd , Watford , UK. 5. e Divisions of Infectious Diseases and Cardiovascular Diseases , Mayo Clinic College of Medicine , Rochester , MN , USA. 6. f Liverpool Heart and Chest Hospital , Liverpool , UK.
Abstract
AIMS: Infection is a major complication of cardiovascular implantable electronic device (CIED) therapy that usually requires device extraction and is associated with increased morbidity and mortality. The TYRX Antibacterial Envelope is a polypropylene mesh that stabilizes the CIED and elutes minocycline and rifampin to reduce the risk of post-operative infection. METHODS: A decision tree was developed to assess the cost-effectiveness of TYRX vs standard of care (SOC) following implantation of four CIED device types. The model was parameterized for a UK National Health Service perspective. Probabilities were derived from the literature. Resource use included drug acquisition and administration, hospitalization, adverse events, device extraction, and replacement. Incremental cost-effectiveness ratios (ICERs) were calculated from costs and quality-adjusted life-years (QALYs). RESULTS: Over a 12-month time horizon, TYRX was less costly and more effective than SOC when utilized in patients with an ICD or CRT-D. TYRX was associated with ICERs of £46,548 and £21,768 per QALY gained in patients with an IPG or CRT-P, respectively. TYRX was cost-effective at a £30,000 threshold at baseline probabilities of infection exceeding 1.65% (CRT-D), 1.95% (CRT-P), 1.87% (IPG), and 1.38% (ICD). LIMITATIONS AND CONCLUSIONS: Device-specific infection rates for high-risk patients were not available in the literature and not used in this analysis, potentially under-estimating the impact of TYRX in certain devices. Nevertheless, TYRX is associated with a reduction in post-operative infection risk relative to SOC, resulting in reduced healthcare resource utilization at an initial cost. The ICERs are below the accepted willingness-to-pay thresholds used by UK decision-makers. TYRX, therefore, represents a cost-effective prevention option for CIED patients at high-risk of post-operative infection.
AIMS: Infection is a major complication of cardiovascular implantable electronic device (CIED) therapy that usually requires device extraction and is associated with increased morbidity and mortality. The TYRX Antibacterial Envelope is a polypropylene mesh that stabilizes the CIED and elutes minocycline and rifampin to reduce the risk of post-operative infection. METHODS: A decision tree was developed to assess the cost-effectiveness of TYRX vs standard of care (SOC) following implantation of four CIED device types. The model was parameterized for a UK National Health Service perspective. Probabilities were derived from the literature. Resource use included drug acquisition and administration, hospitalization, adverse events, device extraction, and replacement. Incremental cost-effectiveness ratios (ICERs) were calculated from costs and quality-adjusted life-years (QALYs). RESULTS: Over a 12-month time horizon, TYRX was less costly and more effective than SOC when utilized in patients with an ICD or CRT-D. TYRX was associated with ICERs of £46,548 and £21,768 per QALY gained in patients with an IPG or CRT-P, respectively. TYRX was cost-effective at a £30,000 threshold at baseline probabilities of infection exceeding 1.65% (CRT-D), 1.95% (CRT-P), 1.87% (IPG), and 1.38% (ICD). LIMITATIONS AND CONCLUSIONS: Device-specific infection rates for high-risk patients were not available in the literature and not used in this analysis, potentially under-estimating the impact of TYRX in certain devices. Nevertheless, TYRX is associated with a reduction in post-operative infection risk relative to SOC, resulting in reduced healthcare resource utilization at an initial cost. The ICERs are below the accepted willingness-to-pay thresholds used by UK decision-makers. TYRX, therefore, represents a cost-effective prevention option for CIEDpatients at high-risk of post-operative infection.
Authors: Melissa Khalil; Kaveh Karimzad; Jean-Bernard Durand; Alexandre E Malek; Issam I Raad; George M Viola Journal: Open Forum Infect Dis Date: 2020-09-13 Impact factor: 3.835
Authors: Bruce L Wilkoff; Giuseppe Boriani; Suneet Mittal; Jeanne E Poole; Charles Kennergren; G Ralph Corey; John C Love; Ralph Augostini; Svein Faerestrand; Sherman S Wiggins; Jeff S Healey; Reece Holbrook; Jeffrey D Lande; Daniel R Lexcen; Sarah Willey; Khaldoun G Tarakji Journal: Circ Arrhythm Electrophysiol Date: 2020-04-12
Authors: Bruce L Wilkoff; Giuseppe Boriani; Suneet Mittal; Jeanne E Poole; Charles Kennergren; G Ralph Corey; Andrew D Krahn; Edward J Schloss; Jose L Gallastegui; Robert A Pickett; Rudolph F Evonich; Steven F Roark; Denise M Sorrentino; Darius P Sholevar; Edmond M Cronin; Brett J Berman; David W Riggio; Hafiza H Khan; Marc T Silver; Jack Collier; Zayd Eldadah; Reece Holbrook; Jeff D Lande; Daniel R Lexcen; Swathi Seshadri; Khaldoun G Tarakji Journal: Circ Arrhythm Electrophysiol Date: 2020-09-11