Medtronic (Spain)

BackgroundInfections represent the most serious complication associated with cardiac implantable electronic devices (CIEDs). This can result in prolonged hospital stays, high morbidity and mortality, and a significant economic burden for healthcare systems.ObjectivesThis study aimed to evaluate the cost-effectiveness of the TYRX absorbable antibacterial envelope for CIED infection prevention from the Spanish Healthcare System perspective.MethodsA decision tree model with a lifetime horizon was developed to compare standard antibiotic prophylaxis with its combination with TYRX, regardless of infection risk. The model incorporated infection incidence, mortality, and utility values up to 36 months, derived from REINFORCE, AdaptResponse, and WRAP-IT studies. Unit costs (2025 euros) included prevention strategies and infection management. Lifetime costs and quality-adjusted life-years (QALYs) were assigned to survivors beyond 36 months. The incremental cost-effectiveness ratio (ICER) was reported by CIED and weighted by implant distribution (permanent pacemaker [PPM, 76.5%], implantable cardioverter-defibrillator [ICD, 15.2%], cardiac resynchronization therapy with defibrillator [CRT-D, 5.4%], and pacemaker [CRT-P, 2.9%]). A subgroup analysis was performed in high-risk patients (PADIT≥7), modifying infection rates based on PADIT risk stratification, along with sensitivity analyses. Model inputs were validated by an expert panel.ResultsTYRX was the dominant strategy (more effective and less costly) for CRT-D and ICD recipients and cost-effective for those receiving PPM (€17 740/QALY) or CRT-P (€14 647/QALY), considering a willingness-to-pay threshold of €25 000/QALY. Across the spectrum of CIEDs, the ICER was €11 709/QALY. TYRX remained cost-effective in 77% of sensitivity analysis simulations. In high-risk patients, TYRX was dominant for all CIEDs.DiscussionThis study is believed to be the first economic evaluation of TYRX in Spain and provides novel evidence in a broad, unselected population. Previous cost-effectiveness analyses conducted across different healthcare systems have consistently shown that TYRX is cost-effective in patients at elevated risk for device-related infections. Although the populations and healthcare settings differ, our findings are consistent with this body of evidence.ConclusionsTYRX represents a dominant strategy for infection prevention for CRT-D and ICD and is cost-effective for PPM and CRT-P, based on Spain’s willingness to pay.

BackgroundInfections represent the most serious complication associated with cardiac implantable electronic devices (CIEDs). This can result in prolonged hospital stays, high morbidity and mortality, and a significant economic burden for healthcare systems.ObjectivesThis study aimed to evaluate the cost-effectiveness of the TYRX absorbable antibacterial envelope for CIED infection prevention from the Spanish Healthcare System perspective.MethodsA decision tree model with a lifetime horizon was developed to compare standard antibiotic prophylaxis with its combination with TYRX, regardless of infection risk. The model incorporated infection incidence, mortality, and utility values up to 36 months, derived from REINFORCE, AdaptResponse, and WRAP-IT studies. Unit costs (2025 euros) included prevention strategies and infection management. Lifetime costs and quality-adjusted life-years (QALYs) were assigned to survivors beyond 36 months. The incremental cost-effectiveness ratio (ICER) was reported by CIED and weighted by implant distribution (permanent pacemaker [PPM, 76.5%], implantable cardioverter-defibrillator [ICD, 15.2%], cardiac resynchronization therapy with defibrillator [CRT-D, 5.4%], and pacemaker [CRT-P, 2.9%]). A subgroup analysis was performed in high-risk patients (PADIT≥7), modifying infection rates based on PADIT risk stratification, along with sensitivity analyses. Model inputs were validated by an expert panel.ResultsTYRX was the dominant strategy (more effective and less costly) for CRT-D and ICD recipients and cost-effective for those receiving PPM (€17 740/QALY) or CRT-P (€14 647/QALY), considering a willingness-to-pay threshold of €25 000/QALY. Across the spectrum of CIEDs, the ICER was €11 709/QALY. TYRX remained cost-effective in 77% of sensitivity analysis simulations. In high-risk patients, TYRX was dominant for all CIEDs.DiscussionThis study is believed to be the first economic evaluation of TYRX in Spain and provides novel evidence in a broad, unselected population. Previous cost-effectiveness analyses conducted across different healthcare systems have consistently shown that TYRX is cost-effective in patients at elevated risk for device-related infections. Although the populations and healthcare settings differ, our findings are consistent with this body of evidence.ConclusionsTYRX represents a dominant strategy for infection prevention for CRT-D and ICD and is cost-effective for PPM and CRT-P, based on Spain’s willingness to pay.

Objetivos. Los pacientes portadores de desfibriladores automáticos implantables (DAI) tienen riesgo de complicaciones graves que son atendidas con frecuencia en los servicios de urgencias hospitalarios (SUH). Este estudio analiza el manejo y el pronóstico de las urgencias en portadores de un DAI. Método. Estudio de cohorte observacional y multicéntrico que incluyó de manera consecutiva pacientes adultos portadores de DAI que consultaron en 27 SUH en España, con seguimiento posterior a 10 años. Se recogieron las variables clínicas, manejo en el SUH, fecha y causa del fallecimiento. La variable de resultado primaria fue la mortalidad por cualquier causa. Resultados. Se incluyeron 503 pacientes, 471 con cardiopatía estructural (CE) y 32 con enfermedad eléctrica primaria cardiaca (EEPC). Se prescribió betabloqueantes en el SUH al 55% de los pacientes con indicación. Durante el seguimiento fallecieron 24 (4,8%), 75 (15,7%) y 368 pacientes (73,2%) a 1 mes, 1 año y 10 años, respectivamente. De estos, 363 tenían CE y 5 EEPC (77,1% vs 15,6%, HR 8,05 IC 95% 3,33-19,46). Entre los pacientes con CE, la mortalidad global fue de causa cardiovascular en el 66% de los casos. La mortalidad se asoció significativamente con la consulta por una causa cardiovascular, edad avanzada, sexo masculino, diabetes, NHYA $ 2, disfunción ventricular grave y tratamiento crónico con amiodarona. Conclusiones. El pronóstico de los portadores de DAI con CE es muy adverso, fundamentalmente debido a complicaciones cardiovasculares en pacientes con comorbilidades que consultan por sintomatología cardiovascular. La mortalidad es menor en los pacientes con EEPC

A novel synthetic fully long-term resorbable self-gripping mesh has been recently developed to reinforce soft tissue where weakness exists during ventral hernia repair open procedures. This resorbable mesh is a macroporous, knitted, poly-L-lactide, poly-trimethylene carbonate copolymer monofilament mesh with the ProGrip™ technology, providing grips on one side of the mesh. A new poly-L-lactide, poly-trimethylene copolymer was developed to provide the required features for mechanical support during at least 20 weeks covering the critical healing period, including resistance to fatigue under cyclic loading conditions, as it occurs in patients. The yarns and mesh initial physical and biomechanical properties were characterized. Then, the mesh mechanical strength was evaluated over time. The mechanical properties of the proposed mesh were found to be above the generally recognized threshold value to mechanically support the repair site of a hernia over a 20-week period during in-vitro cyclic loading test. The mesh performance was evaluated in vivo using a published preclinical porcine model of hernia repair at 4-, 12- and 20-weeks post implantation. The burst strength of the hernia repair sites reinforced with the new mesh were higher at 4 & 12 weeks and comparable at 20 weeks to the one of the native abdominal walls. At all time points, the mesh was well tolerated with moderate inflammation and was fast integrated in the abdominal wall at 4 weeks. Particularly, the grips were nicely engulfed in the newly formed connective tissue. They must facilitate the anchoring of the mesh by their extension from the mesh and their mushroom shape. The preclinical data of the self-gripping resorbable mesh suggests that it has all the favorable characteristics for future clinical use during ventral hernia repair open procedures.Graphical

To determine, using the Delphi method, standardized recommendations for the follow-up of patients undergoing an interventional procedure for the treatment of chronic pain in Spain. First, a systematic literature review was performed to identify the literature on the management of patients with chronic pain undergoing interventional techniques; subsequently, a two-round Delphi survey with 108 questions was conducted. The questionnaire was validated by a Scientific Committee (5 experts) and sent to 47 experts specialized in chronic pain. "Consensus" or "intermediate consensus" was determined when ≥ 75% or < 75% to ≥ 65% of the experts selected the same answer for each item, respectively. Then, a face-to-face deliberation process was held with the Scientific Committee to analyze and discuss the results. The questionnaire was completed by 24 panelists (51%). Consensus was reached on 88.4% of the questions. The panelists identified pain, drug consumption, and quality of life as essential variables in the follow-up of patients with chronic pain. Consensus was reached on most of the scales/questionnaires to be used in measuring outcomes during follow-up, except for psychological status. Regarding the follow-up frequency, in radicular spinal chronic pain, a consensus was reached on the first visit 1-2 months after the intervention, during the first year, at 1, 3, 6, and 12 months, and then every 6 months thereafter. For non-radicular spinal chronic pain, the first visit 1-2 months after surgery was agreed upon, however, there was no consensus on follow-up during the first year. For non-spinal chronic pain, consensus was reached regarding the first visit at 1-2 months after surgery and during the first year at 1, 3, 6, and 12 months. No consensus was reached on follow-up frequency for oncological chronic pain. After receiving a permanent neurostimulator implant for chronic pain, the first visit was agreed upon at 1-3 weeks, during the first year, at 2 weeks, 1, 3, 6, and 12 months, and after, every 6 months. For intrathecal infusion, it was agreed that the first visit should occur during the first month, and thereafter whenever the pump requires a refill. These findings provide recommendations in relation to the frequency of follow-up and the scales to be used with chronic pain patients undergoing interventional techniques in Spain.

Introduction A direct transfer to angiosuite (DTAS) protocol has shown to be effective and safe by shortening in-hospital workflows and encouraging long-term outcome benefits. To implement DTAS at a new facility, a large organizational effort is necessary. We performed a cost-utility analysis and budget impact analysis (BIA) of the operation of a new angiosuite, primarily dedicated to stroke patients, that allows facilities to approximate the cost implications of utilizing a DTAS pathway. Methods Sixty-one patients who underwent endovascular treatment (EVT) following DTAS were matched for baseline variables to 117 patients who underwent a conventional imaging protocol at a hospital in Catalonia, Spain. An economic model, based on actual data from these patients, was developed to assess the short- and long-term clinical and economic implications of DTAS. In the BIA, the DTAS scenario was gradually implemented for 20% of patients each year until reaching a plateau at 80% of patients in the DTAS pathway. Initial investment and additional organizational costs, €4 million, were taken into consideration to compare the budget impact of the DTAS scenario with no organizational changes over five years. Results DTAS was associated with better patient functional independence rates (mRS 0–2: 50.9% vs. 41.0%) and a quality-adjusted life-years gain of 0.82 per patient. Despite the additional initial investment, DTAS development was associated with an estimated 10.2% reduction (€14.7 million) of the total costs (€144.5 million). Cost savings were mainly due to long-term associated costs related to patient disability (€13.2 million). Limitations The study relies on data obtained from a single-center, and therefore it may be difficult to generalize the findings Conclusions Our economic model predicts that the implementation of a DTAS program is cost-effective compared with no organizational changes. Our model also predicts better clinical outcomes for patients in terms of functional independence and quality-adjusted life years.

To assess the cost-effectiveness of stent-retriever mechanical thrombectomy and intravenous tissue plasminogen activator compared with intravenous tissue plasminogen activator alone in patients with acute ischaemic stroke due to large vessel occlusions in Spain. Clinical data were taken from the SWIFT PRIME clinical trial. A lifetime Markov state transition model defined by the modified Rankin Scale score was developed to estimate costs and health outcomes (life years gained and quality adjusted life years). A Spanish National Health System perspective (direct medical costs) was considered. Resource utilisation and utilities were obtained from available published data and endorsed by an expert panel. Costs (€, 2016) were obtained from various Spanish sources. Deterministic and probabilistic sensitivity analyses were performed. Stent-retriever thrombectomy after intravenous tissue plasminogen activator was associated with better outcomes (1.17 life years gained and 2.51 quality adjusted life years) and savings of €44,378, resulting in a dominant therapy over intravenous tissue plasminogen activator alone. A net monetary benefit of €119,744 was obtained considering a willingness-to-pay threshold of €30,000/quality adjusted life year gained. The combined therapy was also dominant in all sensitivity analyses, deterministic and probabilistic. The results were consistent with a previously published cost-effectiveness analysis and reinforce the likeliness of the selection of stent-retriever mechanical thrombectomy plus intravenous tissue plasminogen activator over intravenous tissue plasminogen activator alone. Stent-retriever thrombectomy after intravenous tissue plasminogen activator is a dominant alternative over intravenous tissue plasminogen activator alone (more effective and less costly) for the treatment of acute ischaemic stroke patients with large vessel occlusions in the Spanish setting.