Relatório de custos relacionados às próteses valvares e conjunto de circulação extracorpórea / Cost report related to valve prostheses and circulation set extracorporeal

ASSUNTO: Trata-se de relatório de custos de próteses valvares e conjunto de circulação extracorpórea realizado pelo Núcleo de Avaliação de Tecnologias (NATS INC), sob demanda da Direção Geral do Instituto Nacional de Cardiologia (INC) de modo a contribuir para a resolução do atual impasse sobre os valores de aquisição versus valores de ressarcimento dos procedimentos da Tabela de Procedimentos, Medicamentos, Órteses, Próteses e Materiais do SUS, por parte do Ministério da Saúde (Coordenação Geral de Atenção Especializada -CGAE/DAET/SAES). CONSIDERAÇÕES TÉCNICAS: Método empregado para avaliação dos custos dos matérias em comparação ao valor de ressarcimento da tabela SUS. RESULTADOS: próteses valvares e conjunto de circulação extracorpórea padronizados no INC (extraídos do sistema de gestão de estoques da unidade) com código CATMAT, data e quantidade da última compra (entrada), preço de aquisição, custo médio, código e repasse pelo SIGTAP. A prótese valvar aórtica de pericárdio bovino sem sutura (BR0437592) está em avaliação pela Comissão de Padronização de Material do INC, podendo ou não ser despadronizada. Vale destacar que estes são os códigos adotados no INC após a última revisão de padronização. A criação do código INC 58913 para prótese valvar mitral mecânica 18 a 23 mm teve por objetivo apenas separar as próteses para uso em pediatria, porém o custo unitário provavelmente será o mesmo da prótese descrita no código INC 58182. No caso da circulação extracorpórea, o INC adquiri o oxigenador adulto ­ circuito para circulação extracorpórea e em separado hemoconcentradores e bomba centrífuga, pois estes dois últimos não são utilizados em todos os procedimentos. No ano de 2020 as compras com maior variação de preço ocorreram na região Sudeste. Dos itens com código de repasse do SIGTAP, apenas 3: PRÓTESE VALVULAR MECÂNICA DE DUPLO FOLHETO (07.02.04.057-6); CONJUNTO PARA CIRCULAÇÃO EXTRACORPÓREA (PEDIÁTRICO) (07.02.04.021-5) e BOMBA CENTRÍFUGA DESCARTÁVEL PARA USO EM CIRCULAÇÃO EXTRACORPÓREA E/OU CIRCULAÇÃO ASSITIDA (07.02.05.001-6), apresentaram média de preço inferior ao repasse da tabela SUS. No ano de 2021 a região Sudeste também apresentou as maiores variações de preço. Apenas o CONJUNTO PARA CIRCULAÇÃO EXTRACORPÓREA (PEDIÁTRICO) (07.02.04.021-5), dos itens com código de repasse no SIGTAP, apresentou média de preço inferior ao repasse da tabela SUS. As próteses valvulares e o conjunto de circulação extracorpórea apresentaram variação expressiva de preço. No caso do conjunto de circulação extracorpórea, na região Sudeste o preço variou de -75% a mais de 2.000%. Em pesquisa no site da marca adquirida no valor de R$ 35.000,00, o fabricante relata que são oxigenadores para suporte cardiorrespiratório prolongado (14 dias), com redução no consumo de plaquetas e livre de heparina (adequado para pacientes com trombocitopenia Induzida por heparina aguda). Foram estimadas as médias ponderadas e médias (incluindo o custo do INC, para os matérias adquiridos no período avaliado) de custo unitário com e sem os outliers. Provavelmente estes valores extremamente divergentes se devem ao fato de que itens diferenciados são adquiridos utilizando o mesmo código do CATMAT. Foi realizada uma tentativa de identificação destes itens diferenciados no próprio site sem sucesso. Seria necessário o acesso aos editais de compras das unidades envolvidas, o que não foi possível neste momento (por este motivo os cálculos foram feitos com e sem os outliers). Com exceção dos hemoconcentradores, que não foi localizado código SIGTAP, todos os itens adquiridos nos anos de 2020 e 2021 pelo INC estão com preços abaixo do valor de repasse do SIGTAP.

A Real-World Comparison of 1-Year Survival and Expenditures for Transcatheter Aortic Valve Replacements: SAPIEN 3 Versus CoreValve Versus Evolut R.

OBJECTIVES: New versions of balloon-expandable and self-expandable valves for transcatheter aortic valve replacement (TAVR) have been developed, but few studies have examined the outcomes associated with these devices using national-level data. This study aimed to elucidate the clinical and economic outcomes of TAVR for aortic stenosis in Japan through an analysis of real-world data. METHODS: This retrospective cohort study was performed using data from patients with aortic stenosis who had undergone transfemoral TAVR with Edwards SAPIEN 3, Medtronic CoreValve, or Medtronic Evolut R valves throughout Japan from April 2016 to March 2018. Pacemaker implantation, mortality, and health expenditure were examined for each valve type during hospitalization and at 1 month, 3 months, 6 months, and 1 year. Generalized linear regression models and Cox proportional hazards models were used to examine the associations between the valve types and outcomes. RESULTS: We analyzed 7244 TAVR cases (SAPIEN 3: 5276, CoreValve: 418, and Evolut R: 1550) across 145 hospitals. The adjusted 1-year expenditures for SAPIEN 3, CoreValve, and Evolut R were $79 402, $76 125, and $75 527, respectively; SAPIEN 3 was significantly more expensive than the other valves (P < .05). The pacemaker implantation hazard ratios (95% confidence intervals) for CoreValve and Evolut R were significantly higher (P < .001) than SAPIEN 3 at 2.61 (2.07-3.27) and 1.80 (1.53-2.12), respectively. The mortality hazard ratios (95% confidence intervals) for CoreValve and Evolut R were not significant at 1.11 (0.84-1.46) and 1.22 (0.97-1.54), respectively. CONCLUSIONS: SAPIEN 3 users had generally lower pacemaker implantation and mortality but higher expenditures than CoreValve and Evolut R users.

Use of an Aortic Valve Replacement Simulation Model to Understand Hospital Costs and Resource Utilization Associated With Rapid-deployment Valves.

PURPOSE: Aortic stenosis (AS) is the most common cause of adult valvular heart disease. In the past decade, minimally invasive surgery (MIS) to treat AS has gained popularity, especially if performed in combination with rapid deployment valves (RDVs), which shorten cross-clamp time (XCT). This study examines specific outcomes and related costs of aortic valve replacement (AVR) before and after the introduction of RDVs. METHODS: We used the AVR simulator, an economic model developed to correlate cost and resource utilization associated with the adoption of RDVs, to compare 2 scenarios: (1) a current scenario based on standard AVR practices and (2) a proposed scenario based on increasing use of RDVs and an MIS approach. Both scenarios involved 3 subgroups of patients treated with (1) conventional AVR, (2) MIS, and (3) AVR combined with a coronary artery bypass graft. The current scenario (status quo) involved patients treated with traditional biological valves, and the proposed scenario involved patients who underwent implantation with an RDV. The AVR simulator was fed with real-world input data to estimate complication rates and resource consumption in the proposed scenario. Real-world input data for this analysis were obtained from patients diagnosed with a symptomatic heart valve disease between 2015 and 2018, at Clinica-San-Gaudenzio, Novara, Italy. Lastly, the AVR simulator estimated hospital savings by comparing the 2 scenarios. FINDINGS: A total of 132 patients underwent implantation with a traditional biological valve, and 107 were treated with a commercial valve system. The RDV was associated with an increase of 52% of patients undergoing MIS, which generated a 6.1-h reduction of XCT and a total savings of €6695. RDVs also reduced intensive care unit (ICU) and hospital ward length of stay (LOS), leading to savings of €677 and €595 per patient, respectively. Mortality and blood transfusions also improved. The savings for the hospital (related to shorter XCT, hospital ward LOS, and ICU LOS) amounted to €144.111. Our findings were consistent with data gathered from our real-word setting, and results of a sensitivity analysis indicate that our findings were robust across different possible situations. IMPLICATIONS: Switching to RDVs and MIS procedures for AVRs was associated with a reduction of costs related to XCT, hospital ward LOS, and ICU LOS. Hospitals can upload literature- and experience-based clinical and cost values to the AVR simulator to estimate a hospital's performance with the introduction of RDVs compared with standard biological valves. This study was not randomized, so more extensive studies could confirm our results in the future.

Early cost-utility analysis of tissue-engineered heart valves compared to bioprostheses in the aortic position in elderly patients.

OBJECTIVES: Aortic valve disease is the most frequent indication for heart valve replacement with the highest prevalence in elderly. Tissue-engineered heart valves (TEHV) are foreseen to have important advantages over currently used bioprosthetic heart valve substitutes, most importantly reducing valve degeneration with subsequent reduction of re-intervention. We performed early Health Technology Assessment of hypothetical TEHV in elderly patients (≥ 70 years) requiring surgical (SAVR) or transcatheter aortic valve implantation (TAVI) to assess the potential of TEHV and to inform future development decisions. METHODS: Using a patient-level simulation model, the potential cost-effectiveness of TEHV compared with bioprostheses was predicted from a societal perspective. Anticipated, but currently hypothetical improvements in performance of TEHV, divided in durability, thrombogenicity, and infection resistance, were explored in scenario analyses to estimate quality-adjusted life-year (QALY) gain, cost reduction, headroom, and budget impact. RESULTS: Durability of TEHV had the highest impact on QALY gain and costs, followed by infection resistance. Improved TEHV performance (- 50% prosthetic valve-related events) resulted in lifetime QALY gains of 0.131 and 0.043, lifetime cost reductions of €639 and €368, translating to headrooms of €3255 and €2498 per hypothetical TEHV compared to SAVR and TAVI, respectively. National savings in the first decade after implementation varied between €2.8 and €11.2 million (SAVR) and €3.2-€12.8 million (TAVI) for TEHV substitution rates of 25-100%. CONCLUSIONS: Despite the relatively short life expectancy of elderly patients undergoing SAVR/TAVI, hypothetical TEHV are predicted to be cost-effective compared to bioprostheses, commercially viable and result in national cost savings when biomedical engineers succeed in realising improved durability and/or infection resistance of TEHV.

Cost-Effectiveness of Transcatheter Aortic Valve Implantation Using a Balloon-Expandable Valve in Japan: Experience From the Japanese Pilot Health Technology Assessment.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an innovative and effective treatment in high-surgical-risk (HR) and inoperable patients with symptomatic severe aortic stenosis. OBJECTIVES: This cost-effectiveness analysis of transfemoral TAVI (TF-TAVI) compared with surgical aortic valve replacement (SAVR) conforms with the methodological guidelines for cost-effectiveness evaluation by the Ministry of Health, Labor, and Welfare in Japan. METHODS: The cost-effectiveness of TF-TAVI using SAPIEN XT was evaluated using a lifetime Markov simulation from the national payer perspective. Comparators were SAVR for HR patients and standard of care (SOC) for inoperable patients. A systematic literature review for clinical evidence of TF-TAVI and comparators was conducted. The evidence for TF-TAVI was derived from the SOURCE XT registry and Japanese post marketing surveillance. Because there was no literature directly or indirectly comparing TF-TAVI using SAPIEN XT with comparators, the comparator data were selected from relevant published studies, considering the similarity of study eligibility criteria and patient backgrounds (eg, age and surgical risk scores). Sensitivity analyses were used to validate the robustness of results. RESULTS: The incremental cost-effectiveness ratio of TF-TAVI versus SAVR for HR patients was ¥1.3 million/quality-adjusted life-years (QALYs). The incremental cost-effectiveness ratio of TF-TAVI versus SOC for inoperable patients was ¥3.5 million/QALY. CONCLUSIONS: TF-TAVI was cost-effective when compared with SAVR for HR patients and when compared with SOC for inoperable patients, using a threshold of ¥5 million/QALY.

Left Ventricular Rapid Pacing Via the Valve Delivery Guidewire in Transcatheter Aortic Valve Replacement.

OBJECTIVES: This study investigated whether left ventricular (LV) stimulation via a guidewire-reduced procedure duration while maintaining efficacy and safety compared with standard right ventricular (RV) stimulation. BACKGROUND: Rapid ventricular pacing is necessary to ensure cardiac standstill during transcatheter aortic valve replacement (TAVR). METHODS: This is a prospective, multicenter, single-blinded, superiority, randomized controlled trial. Patients undergoing transfemoral TAVR with a SAPIEN valve (Edwards Lifesciences, Irvine, California) were allocated to LV or RV stimulation. The primary endpoint was procedure duration. Secondary endpoints included efficacy, safety, and cost at 30 days. RESULTS: Between May 2017 and May 2018, 307 patients were randomized, but 4 were excluded because they did not receive the intended treatment: 303 patients were analyzed in the LV (n = 151) or RV (n = 152) stimulation groups. Mean procedure duration was significantly shorter in the LV stimulation group (48.4 ± 16.9 min vs. 55.6 ± 26.9 min; p = 0.0013), with a difference of -0.12 (95% confidence interval: -0.20 to -0.05) in the log-transformed procedure duration (p = 0.0012). Effective stimulation was similar in the LV and RV stimulation groups: 124 (84.9%) versus 128 (87.1%) (p = 0.60). Safety of stimulation was also similar in the LV and RV stimulation groups: procedural success occurred in 151 (100%) versus 151 (99.3%) patients (p = 0.99); 30-day MACE-TAVR (major adverse cardiovascular event-transcatheter aortic valve replacement) occurred in 21 (13.9%) versus 26 (17.1%) patients (p = 0.44); fluoroscopy time (min) was lower in the LV stimulation group (13.48 ± 5.98 vs. 14.60 ± 5.59; p = 0.02), as was cost (€18,807 ± 1,318 vs. €19,437 ± 2,318; p = 0.001). CONCLUSIONS: Compared with RV stimulation, LV stimulation during TAVR was associated with significantly reduced procedure duration, fluoroscopy time, and cost, with similar efficacy and safety. (Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVR [EASY TAVI]; NCT02781896).

Is the MitraClip® procedure profitable in a high-volume French hospital?

BACKGROUND: Mitral regurgitation is the second most frequent valvulopathy managed by surgery in Europe. For patients who have a contraindication to surgery or a high surgical risk, the percutaneous MitraClip® implantation procedure has emerged as a favourable alternative approach, but elevated procedural costs are a medicoeconomic concern. AIM: The objective of this study was to evaluate whether the MitraClip® procedure is profitable in a high-volume French hospital. METHODS: Patients eligible for mitral valve repair with a MitraClip® device, and covered by the French National Health Service, were included retrospectively in this single-centre study between September 2016 and June 2018. Subgroups were considered based on medicoeconomic severity level. The study primary endpoint was the difference between hospital costs and revenues, calculated for each patient. Secondary endpoints included profit based on severity level, breakdown of costs and adverse events during hospitalization. RESULTS: Twenty-two patients were included in the study. The mean hospital cost and revenue were €30,039±2476 and €30,331±2720 per patient, respectively, resulting in a profit of €292±2039 per patient. The total estimated profit was €6429 for the whole study period. The largest benefits were observed for patients assigned to the higher medicoeconomic severity levels (levels 2 and 3). Profit increased following a reduction in the device cost (€1136±2415 per patient). The price of the device represented 78% of the total costs. CONCLUSIONS: Percutaneous MitraClip implantation is a financially neutral procedure for a French university hospital, but this depends on patient severity level.

Cost-effectiveness of transcatheter aortic valve implantation compared to surgical aortic valve replacement in the intermediate surgical risk population.

BACKGROUND: The recent PARTNER S3i trial compared transcatheter aortic valve implantation (TAVI) using the third-generation SAPIEN 3 device to surgical aortic valve replacement (SAVR) in intermediate-risk patients with severe symptomatic aortic stenosis. Using data from PARTNER S3i, we performed a contemporary cost-effectiveness analysis of current-generation TAVI versus SAVR from the Australian healthcare system perspective. METHODS: A Markov model with monthly cycles and a ten-year horizon was constructed to estimate costs, life-years and quality adjusted life-years (QALYs) associated with TAVI and SAVR. Efficacy inputs were derived from the PARTNER S3i study. Costs were estimated from published sources. Deterministic and probabilistic sensitivity analyses were performed to assess model uncertainty. RESULTS: TAVI was found to have higher immediate procedural costs than SAVR, driven primarily by the cost of the transcatheter valve. This was offset by a shorter length of hospitalisation following TAVI, such that the combined cost of initial procedure and hospitalisation was lower in TAVI compared to SAVR. With 5% annual discounting, total costs over ten-years were $50,515 AUD in TAVI and $60,144 AUD in SAVR, and TAVI was found to produce 0.33 more life years and 0.31 more QALYs than SAVR. Thus, from a health economic perspective, TAVI was dominant compared to SAVR. Results were robust to sensitivity analyses, with TAVI being dominant in 68% of 10,000 Monte Carlo iterations and cost-effective in 92% of iterations at a willingness-to-pay threshold of $50,000/QALY gained. CONCLUSIONS: TAVI is likely to be highly cost-effective compared to SAVR in intermediate-risk patients with severe aortic stenosis.

Cost-comparison of third generation transcatheter aortic valve implantation (TAVI) devices in the German Health Care System.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has a substantial impact on daily cardiovascular care delivery based on issues such as cost effectiveness and economic value within a restricted health care budget. Until now, potential financial benefits of third generation valve models have not been evaluated in a real-world setting. METHODS AND RESULTS: We identified 204 eligible patients (Jan 2014-Sep 2016) who either received the balloon-expandable Edwards Sapien 3 (ES3) or the self-expandable Medtronic Evolut R (MER). Baseline information, procedural characteristics, 30-day outcome as well as in-hospital costs and reimbursement were collected and analyzed. The major cost driver was initial valve-kit costs with a significantly higher amount in the ES3 group, which was set at 0 with the lower price (ES3/MER: +4390.0€â€¯±â€¯3.807.0 vs. 0.0€â€¯±â€¯734.1; p < 0.01). However, initial valve-kit costs were balanced by additional material costs in the MER cohort. Overall costs did not differ significantly between valve models (ES3/MER: x + 13.808.0€â€¯±â€¯5.595.0 vs. x + 10.681.0€â€¯±â€¯4.518.0; p = 0.6885) and reimbursement was moderate (ES3/MER: 1.649.7€ vs. 4776.7€). CONCLUSION: Quality, success rate, and costs were comparable between third generation devices. Initial valve-kit costs were significantly higher in the ES3 group, whereas overall costs did not significantly differ between the two valve types.

Cost-Effectiveness of Self-Expandable Transcatheter Aortic Valves in Intermediate-Risk Patients.

BACKGROUND: A recent clinical trial showed that self-expandable transcatheter aortic valve replacement (TAVR) was non-inferior to surgical aortic valve replacement (SAVR). However, the cost-effectiveness of self-expandable TAVR in the intermediate-risk population remains unknown. METHODS: A cost-utility analysis from the Canadian health care system payer's perspective was undertaken to compare self-expandable TAVR with SAVR. A fully probabilistic Markov model over the patient's lifetime was constructed to estimate differences in costs (2016 Canadian dollars) and effectiveness (quality-adjusted life-years [QALYs]), discounted at 1.5% per annum. Incremental cost-effectiveness ratios (ICERs) were calculated. Efficacy inputs were obtained from the Surgical Replacement and Transcatheter Aortic Valve Implantation trial, and costs were primarily obtained from the Canadian Institute of Health Information. Probabilistic analysis (PA) and one-way deterministic sensitivity analyses were conducted around key point estimates to address uncertainty. RESULTS: In the base case analysis, with discounting, the total lifetime costs (mean ± standard deviation) in the TAVR and SAVR arms were $44,299 ± $7,260 and $32,994 ± $13,434, respectively, whereas total effectiveness values were 6.42 ± 1.33 QALYs and 6.28 ± 1.32 QALYs, respectively. This yielded an incremental cost of $11,305 and incremental effectiveness of 0.15 QALYs when TAVR was compared with SAVR for an ICER of $76,736/QALY. In the PA, there was moderate uncertainty, with 52.8% and 57.2% of simulations less than willingness-to-pay thresholds of $50,000 and $100,000, respectively. In the sensitivity analysis, when the cost of TAVR valve system was priced at $17,397 (base case $22,000 Canadian dollars), TAVR was found to be cost-effective at a willingness-to-pay threshold of $50,000/QALY. CONCLUSIONS: Self-expandable TAVR was found to be cost-effective; however, there was moderate uncertainty, reflecting the non-inferiority nature of the data.

Is transcatheter aortic valve replacement a profitable procedure in a high-volume French hospital?

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has revolutionized the prognosis of inoperable patients with severe aortic valve stenosis. Yet, the implantation of expensive prostheses in patients with comorbidities may be questionable in an era when healthcare costs are becoming a major concern. AIM: The objective of this study was to assess whether the TAVR procedure is profitable in a high-volume French hospital. METHODS: Consecutive patients eligible for transfemoral TAVR using the SAPIEN bioprostheses (Edwards Lifesciences, Irvine, CA, USA) were included retrospectively in this single-centre study between September 2014 and December 2015. Three medicoeconomic severity-level subgroups were considered. The primary clinical endpoint was the difference between hospital costs and revenues, calculated for each patient. Secondary composite endpoints included major adverse events within 30 days and breakdown of costs. RESULTS: Overall, 189 patients were included in the analysis. Three patients died (two from non-cardiac causes) within 30 days of the procedure. The mean hospital cost was €27,530±3814 per patient, and the mean hospital income was €30,313±2681 per patient (P<0.001), resulting in a significant profit of €2783±1743 per patient. The total estimated profit was €525,000 for the whole study period. The largest benefits were observed for patients assigned to the lowest severity level. The price of the bioprosthesis represented 71% of the total costs. CONCLUSIONS: The TAVR procedure performed in carefully selected patients was profitable for the academic centre, regardless of the level of severity assigned to the patients.

Cost and contribution margin of transcatheter versus surgical aortic valve replacement.

OBJECTIVE: To compare the cost of and payments for transcatheter aortic valve replacement (TAVR), a novel and expensive technology, and surgical aortic valve replacement (SAVR). METHODS: Medicare claims provided hospital charges, payments, and outcomes between January and December 2012. Hospital costs and charges were estimated using hospital-specific cost-to-charge ratios. Costs and payments were examined in propensity score- matched TAVR and SAVR patients. RESULTS: Medicare spent $215,770,200 nationally on 4083 patients who underwent TAVR in 2012. Hospital costs were higher for TAVR patients (median, $50,200; interquartile range [IQR], $39,800-$64,300) than for propensity-matched SAVR patients ($45,500; IQR, $34,500-$63,300; P < .01), owing largely to higher estimated medical supply costs, including the implanted valve prosthesis. Postprocedure hospital length of stay (LOS) length was shorter for TAVR patients (median, 5 days [IQR, 4-8 days] vs 7 days [IQR, 5-9 days]; P < .01), as was total intensive care unit (ICU) LOS (median, 2 days [IQR, 0-5 days] vs 3 days [IQR, 1-6 days]; P < .01). Medicare payments were lower for TAVR hospitalizations (median, $49,500; IQR, $36,900-$64,600) than for SAVR (median, $50,400; IQR, $37,400-$65,800; P < .01). The median of the differences between payments and costs (contribution margin) was -$3380 for TAVR hospitalizations and $2390 for SAVR hospitalizations (P < .01). CONCLUSIONS: TAVR accounted for $215 million in Medicare payments in its first year of clinical use. Among SAVR Medicare patients at a similar risk level, TAVR was associated with higher hospital costs despite shorter ICU LOS and hospital LOS. Overall and/or medical device cost reductions are needed for TAVR to have a net neutral financial impact on hospitals.

The economic value of rapid deployment aortic valve replacement via full sternotomy.

AIM: To compare the economic value of EDWARDS INTUITY Elite™ (EIE) valve system for rapid-deployment aortic valve replacement (RDAVR) in a full sternotomy (FS) approach (EIE-FS-RDAVR) versus FS-AVR using conventional stented bioprosthesis. DATA & METHODS: A simulation model to compare each treatment's 30-day inpatient utilization and complication rates utilized: clinical end points obtained from the TRANSFORM trial patient subset (EIE-FS-RDAVR) and a best evidence review of the published literature (FS-AVR); and costs from the Premier database and published literature. RESULTS: EIE-FS-RDAVR costs $800 less than FS-AVR per surgery episode attributable to lowered complication rates and utilization. Combined with the lower mortality, EIE-FS-RDAVR was a superior (dominant) technology versus FS-AVR. CONCLUSION: This preliminary investigation of EIE-FS-RDAVR versus conventional FS-AVR found the EIE valve offered superior economic value over a 30-day period. Real-world analyses with additional long-term follow-up are needed to evaluate if this result can be replicated over a longer timeframe.

Pathophysiology, incidence and predictors of conduction disturbances during Transcatheter Aortic Valve Implantation.

INTRODUCTION: Over the past decade, transcatheter aortic valve implantation (TAVI) has evolved rapidly toward an extremely reproducible, safe and effective procedure, with a marked reduction of its related complications. However, the occurrence of conduction disturbances and the need for permanent pacemaker implantation (PPI) after TAVI remains a concern. Areas covered: In this article review, we will go through the mechanisms involved in conduction disturbances after TAVI, and we will discuss the key aspects of pathophysiology, incidence and predictors of conduction disturbances following Transcatheter Aortic Valve Implantation. The evaluation of patient's valve anatomy and the selection of the most appropriate prosthesis have been proposed as a valuable options to reduce the incidence of conductions disturbances. Moreover, in recent times, a great number of new TAVI devices, so-called 'second-generation devices', have been introduced to address the limitations of the first-generation devices, including conduction disturbance, with scarce results. Expert commentary: Conduction disturbances after TAVI are increasingly recognized as an important issue in TAVI complications. Further characterization of the procedural- and patient-related factors that contribute to the development of conduction abnormalities will help to improve prosthesis designs and patient selection, making TAVI even more safer.

In-hospital cost comparison between percutaneous pulmonary valve implantation and surgery.

Objectives: Today, both surgical and percutaneous techniques are available for pulmonary valve implantation in patients with right ventricle outflow tract obstruction or insufficiency. In this controlled, non-randomized study the hospital costs per patient of the two treatment options were identified and compared. Methods: During the period of June 2011 until October 2014 cost data in 20 patients treated with the percutaneous technique and 14 patients treated with open surgery were consecutively included. Two methods for cost analysis were used, a retrospective average cost estimate (overhead costs) and a direct prospective detailed cost acquisition related to each individual patient (patient-specific costs). Results: The equipment cost, particularly the stents and valve itself was by far the main cost-driving factor in the percutaneous pulmonary valve group, representing 96% of the direct costs, whereas in the open surgery group the main costs derived from the postoperative care and particularly the stay in the intensive care department. The device-related cost in this group represented 13.5% of the direct costs. Length-of-stay-related costs in the percutaneous group were mean $3885 (1618) and mean $17 848 (5060) in the open surgery group. The difference in postoperative stay between the groups was statistically significant ( P ≤ 0.001). Conclusions: Given the high postoperative cost in open surgery, the percutaneous procedure could be cost saving even with a device cost of more than five times the cost of the surgical device.

Economic Evaluation of the Combined Use of Warfarin and Low-dose Aspirin Versus Warfarin Alone in Mechanical Valve Prostheses.

BACKGROUND: The use of combined therapy of antiplatelet and anticoagulant versus anticoagulant alone to reduce instances of thromboembolic events in patients with heart valve prostheses is an established standard of care in many countries but not in Egypt. A previous Markov model cost-effectiveness study on Egyptian patients aged 50-60 years demonstrated that the combined therapy reduces the overall treatment cost. However, due to the lack of actual real-world data on cost-effectiveness and the limitation of the Markov model study to 50- to 60-year-old patients, the Egyptian medical community is still questioning whether the added benefit is worth the cost. OBJECTIVE: To assess, from the perspective of the Egyptian health sector, the cost-effectiveness of the combined use of warfarin and low-dose aspirin (75 mg) versus that of warfarin alone in patients with mechanical heart valve prostheses who began therapy between the age of 15 and 50 years. METHODS: An economic evaluation was conducted alongside a randomized, controlled trial to assess the cost-effectiveness of the combined therapy in patients with mechanical valve prostheses. A total of 316 patients aged between 15 and 50 years were included in the study and randomly assigned to a group treated with both warfarin and aspirin or a group treated with warfarin alone. RESULTS: The patients in the combined therapy group exhibited a significantly longer duration of protection against the first event. Fewer primary events were observed in the patients treated with warfarin plus aspirin than in those treated with warfarin alone (1.4 %/year, vs. 4.8 %/year), and a higher mean quality-adjusted life-years (QALYs) value over 4 years was obtained for the group treated with warfarin plus aspirin (difference 0.058; 95 % CI 0.013-0.118), although this difference did not reach a conventional level of statistical significance. The total costs over a 4-year period were lower with the combined therapy (difference -US$244; 95 % CI -US$483.1 to -US$3.8), which yielded an incremental cost-effectiveness ratio of -US$4206 per QALY gained. Thus, the combined therapy was dominant. All costs were reported in US dollars (USD) for the financial year 2014. CONCLUSIONS: The results of this analysis indicate that from the perspective of the Egyptian health sector, the addition of aspirin to the typical warfarin therapy is more effective and less costly for patients with mechanical valve prostheses than treatment with warfarin alone. This combined strategy could be adopted to prevent the complications of mechanical valve prostheses. Our study adds to the body of evidence supporting the option of warfarin-plus-aspirin therapy for patients with mechanical valve prostheses.

Cost-Effectiveness of Transcatheter Aortic Valve Replacement With a Self-Expanding Prosthesis Versus Surgical Aortic Valve Replacement.

BACKGROUND: Previous studies of the cost-effectiveness of transcatheter aortic valve replacement (TAVR) have been based primarily on a single balloon-expandable system. OBJECTIVES: The goal of this study was to evaluate the cost-effectiveness of TAVR with a self-expanding prosthesis compared with surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis and high surgical risk. METHODS: We performed a formal economic analysis on the basis of individual, patient-level data from the CoreValve U.S. High Risk Pivotal Trial. Empirical data regarding survival and quality of life over 2 years, and medical resource use and hospital costs through 12 months were used to project life expectancy, quality-adjusted life expectancy, and lifetime medical costs in order to estimate the incremental cost-effectiveness of TAVR versus SAVR from a U.S. RESULTS: Relative to SAVR, TAVR reduced initial length of stay an average of 4.4 days, decreased the need for rehabilitation services at discharge, and resulted in superior 1-month quality of life. Index admission and projected lifetime costs were higher with TAVR than with SAVR (differences $11,260 and $17,849 per patient, respectively), whereas TAVR was projected to provide a lifetime gain of 0.32 quality-adjusted life-years ([QALY]; 0.41 LY) with 3% discounting. Lifetime incremental cost-effectiveness ratios were $55,090 per QALY gained and $43,114 per LY gained. Sensitivity analyses indicated that a reduction in the initial cost of TAVR by ∼$1,650 would lead to an incremental cost-effectiveness ratio <$50,000/QALY gained. CONCLUSIONS: In a high-risk clinical trial population, TAVR with a self-expanding prosthesis provided meaningful clinical benefits compared with SAVR, with incremental costs considered acceptable by current U.S. STANDARDS: With expected modest reductions in the cost of index TAVR admissions, the value of TAVR compared with SAVR in this patient population would become high. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement [Medtronic CoreValve U.S. Pivotal Trial]; NCT01240902).