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).

Impact of One-Catheter Strategy with TIG I Catheter on Coronary Catheterization Performance and Economic Costs / Impacto da Estratégia de um Cateter com Cateter TIG I no Desempenho da Coronariografia por Cateterismo e Custos Econômicos

Abstract Background: Coronary angiography with two catheters is the traditional strategy for diagnostic coronary procedures. TIG I catheter permits to cannulate both coronary arteries, avoiding exchanging catheters during coronary angiography by transradial access. Objective: The aim of this study is to evaluate the impact of one-catheter strategy, by avoiding catheter exchange, on coronary catheterization performance and economic costs. Methods: Transradial coronary diagnostic procedures conducted from January 2013 to June 2017 were collected. One-catheter strategy (TIG I catheter) and two-catheter strategy (left and right Judkins catheters) were compared. The volume of iodinated contrast administered was the primary endpoint. Secondary endpoints included radial spasm, procedural duration (fluoroscopy time) and exposure to ionizing radiation (dose-area product and air kerma). Direct economic costs were also evaluated. For statistical analyses, two-tailed p-values < 0.05 were considered statistically significant. Results: From a total of 1,953 procedures in 1,829 patients, 252 procedures were assigned to one-catheter strategy and 1,701 procedures to two-catheter strategy. There were no differences in baseline characteristics between the groups. One-catheter strategy required less iodinated contrast [primary endpoint; (60-105)-mL vs. 92 (64-120)-mL; p < 0.001] than the two-catheter strategy. Also, the one-catheter group presented less radial spasm (5.2% vs. 9.3%, p = 0.022) and shorter fluoroscopy time [3.9 (2.2-8.0)-min vs. 4.8 (2.9-8.3)-min, p = 0.001] and saved costs [149 (140-160)-€/procedure vs. 171 (160-183)-€/procedure; p < 0.001]. No differences in dose-area product and air kerma were detected between the groups. Conclusions: One-catheter strategy, with TIG I catheter, improves coronary catheterization performance and reduces economic costs compared to traditional two-catheter strategy in patients referred for coronary angiography.

Resumo Fundamento: A cineangiocoronariografia com dois cateteres é a estratégia tradicional para procedimentos coronarianos de diagnóstico. O cateter TIG I permite canular ambas as artérias coronárias, evitando a troca de cateteres durante a cineangiocoronariografia por acesso transradial. Objetivo: O objetivo deste estudo é avaliar o impacto da estratégia de um cateter, evitando a troca de cateter, no desempenho da coronariografia por cateterismo e nos seus custos econômicos. Métodos: Foram coletados os procedimentos diagnósticos coronarianos transradiais realizados entre janeiro de 2013 e junho de 2017. A estratégia de um cateter (cateter TIG I) e a estratégia de dois cateteres (cateteres coronários direito e esquerdo de Judkins) foram comparadas. O volume de contraste iodado administrado foi o endpoint primário. Os endpoints secundários eram espasmo radial, duração do procedimento (tempo de fluoroscopia) e exposição a radiações ionizantes (produto dose-área e kerma no ar). Os custos econômicos diretos também foram avaliados. Para as análises estatísticas, valores de p < 0,05 bicaudais foram considerados estatisticamente significativos. Resultados: De um total de 1.953 procedimentos em 1.829 pacientes, 252 procedimentos foram atribuídos à estratégia de um cateter e 1.701 procedimentos à estratégia de dois cateteres. Não houve diferenças nas características basais entre os grupos. A estratégia de um cateter exigiu menos contraste iodado [endpoint primário; (60-105) -mL vs. 92 (64-120) -mL; p < 0,001] em comparação com a estratégia de dois cateteres. Além disso, o grupo da estratégia de um cateter apresentou menos espasmo radial (5,2% vs. 9,3%, p = 0,022) e menor tempo de fluoroscopia [3,9 (2,2-8,0) -min vs. 4,8 (2,9-8,3) -min, p = 0,001] e economia de custos [149 (140-160)-€/procedimento vs. 171 (160-183) -€/procedimento; p < 0,001]. Não foram detectadas diferenças no produto dose-área e kerma no ar entre os grupos. Conclusões: A estratégia de um cateter, com cateter TIG I, melhora o desempenho da coronariografia por cateterismo e reduz os custos econômicos em comparação com a estratégia tradicional de dois cateteres em pacientes encaminhados para cineangiocoronariografia.

Economic impact of atrial fibrillation ablation with radiofrequency contact force catheter versus cryoballoon catheter.

AIM: To compare health utilization among atrial fibrillation (AF) patients undergoing ablation with a contact force-sensing (CF) catheter versus a cryoballoon (CB) catheter. METHODS: AF patients who underwent ablation using the CF catheter (THERMOCOOL SMARTTOUCH® catheter) or CB catheter (Arctic Front™/Arctic Front Advance™ catheter) were identified from the Premier Healthcare database. Propensity score analyses were used to evaluate cost, length of stay and readmissions. RESULTS: The CF catheter (n = 1409) was associated with significantly lower total (∼7%) and supply (∼13%) costs and a significantly lower likelihood of 4-12 month all-cause and CV-related readmission compared with the CB catheter (n = 2306). CONCLUSION: Differential health utilization outcomes are associated with the CF catheter versus the CB catheter in AF ablation.

The Impact of Cryoballoon Versus Radiofrequency Ablation for Paroxysmal Atrial Fibrillation on Healthcare Utilization and Costs: An Economic Analysis From the FIRE AND ICE Trial.

BACKGROUND: This study sought to assess payer costs following cryoballoon or radiofrequency current (RFC) catheter ablation of paroxysmal atrial fibrillation in the randomized FIRE AND ICE trial. METHODS AND RESULTS: A trial period analysis of healthcare costs evaluated the impact of ablation modality (cryoballoon versus RFC) on differences in resource use and associated payer costs. Analyses were based on repeat interventions, rehospitalizations, and cardioversions during the trial, with unit costs based on 3 national healthcare systems (Germany [€], the United Kingdom [£], and the United States [$]). Total payer costs were calculated by applying standard unit costs to hospital stays, using International Classification of Diseases, 10th Revision diagnoses and procedure codes that were mapped to country-specific diagnosis-related groups. Patients (N=750) randomized 1:1 to cryoballoon (n=374) or RFC (n=376) ablation were followed for a mean of 1.5 years. Resource use was lower in the cryoballoon than the RFC group (205 hospitalizations and/or interventions in 122 patients versus 268 events in 154 patients). The cost differences per patient in mean total payer costs during follow-up were €640, £364, and $925 in favor of cryoballoon ablation (P=0.012, 0.013, and 0.016, respectively). This resulted in trial period total cost savings of €245 000, £140 000, and $355 000. CONCLUSIONS: When compared with RFC ablation, cryoballoon ablation was associated with a reduction in resource use and payer costs. In all 3 national healthcare systems analyzed, this reduction resulted in substantial trial period cost savings, primarily attributable to fewer repeat ablations and a reduction in cardiovascular rehospitalizations with cryoballoon ablation. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Identifier: NCT01490814.

Navvus FFR to reduce CONTRAst, Cost and radiaTion (CONTRACT); insights from a single-centre clinical and economical evaluation with the RXi Rapid-Exchange FFR device.

OBJECTIVES: To assess whether the RXi Navvus system compared to the use of standard Fractional Flow Reserve (FFR) wires reduces total contrast volume, radiation and overall study cost in a real world patient population referred for coronary angiography or percutaneous coronary intervention. BACKGROUND: FFR is the mainstay of functional hemodynamic assessment of coronary artery lesions. The RXi Navvus system (ACIST Medical Systems, Eden Prairie, MN) is a monorail microcatheter with FFR-measurement capability through optical pressure sensor technology. METHODS: This is an investigator-initiated, prospective, single-center, observational cohort study. A total of 238 patients were enrolled, 97 patients with Navvus and 141 with conventional pressure-wire based FFR (PW-FFR). Final analyses were performed on the cohort in which only 1 device was used (82 Navvus procedures vs. 136 PW-FFR procedures). RESULTS: No significant differences were found in the total amount of contrast used (150±77 vs 147±79ml; p=0.81), radiation use (6200±4601 vs. 5076±4655 centiG∗cm2; p=0.09) or costs (€1994,- vs. €1930,-; p=0.32) in the Navvus vs. PW-FFR groups respectively. CONCLUSIONS: No significant differences were found in the amount of contrast used, total procedural costs or radiation when the Navvus system was used as compared to conventional FFR wires. CONDENSED ABSTRACT: CONTRACT is an investigator-initiated, prospective, single-center, observational cohort study that evaluated whether the RXi Navvus system compared to the use of standard Fractional Flow Reserve (FFR) wires reduces total contrast volume, radiation and overall study cost in a real world patient population referred for coronary angiography or percutaneous coronary intervention. Use of the RXi Navvus system was associated with comparable procedural costs, amount of radiation and contrast used as compared to PW-FFR systems.

Outcomes and costs associated with two different lead-extraction approaches: a single-centre study.

AIMS: We sought to compare outcomes and costs of a stepwise approach to transvenous lead extraction (TLE) involving laser-assisted sheaths or mechanical polypropylene sheaths, with/without crossover. METHODS AND RESULTS: We prospectively included patients who underwent TLE (between August 2013 and December 2014) as part of a stepwise approach involving simple traction, lead snaring, and sheath-assisted dissection; all of these patients underwent a first-line polypropylene-sheath-extraction approach (Group A). The comparison group (Group B) was consecutive patients who had undergone TLE before August 2013, during which laser-assisted sheath extraction was the first-line approach. The number of patients in Group B was adjusted to match the number who eventually needed sheaths in Group A. Procedural data, outcomes, and costs were compared between groups (comparison of approaches) and in patients who needed sheath-assisted extraction (comparison of techniques). Overall, 521 leads were extracted (131 patients in Group A, 104 in Group B). Radiological and clinical success rates were similar; crossover from polypropylene to laser sheaths was needed in 10 patients in Group A (vs. none in Group B). Radiological (P< 0.001) and clinical (P= 0.01) success rates were higher and were achieved with a lower radiation exposure (P= 0.03) with laser sheaths in patients (60 in each group) who needed sheath-assisted extraction. Complication rates were similar in both groups (P= 0.66) but two deaths occurred in Group B. The laser approach had higher material cost (P= 0.002). CONCLUSIONS: Although laser-assisted TLE was more effective than polypropylene sheath-assisted TLE, the latter was associated with fewer complications and was more cost-effective.

Use of pulmonary artery catheter in coronary artery bypass graft. Costs and long-term outcomes.

BACKGROUND: Pulmonary artery catheters (PAC) are used widely to monitor hemodynamics in patients undergoing coronary bypass graft (CABG) surgery. However, recent studies have raised concerns regarding both the effectiveness and safety of PAC. Therefore, our aim was to determine the effects of the use of PAC on the short- and long-term health and economic outcomes of patients undergoing CABG. METHODS: 1361 Chinese patients who consecutively underwent isolated, primary CABG at the Cardiovascular Institute of Fuwai Hospital from June 1, 2012 to December 31, 2012 were included in this study. Of all the patients, 453 received PAC during operation (PAC group) and 908 received no PAC therapy (control group). Short-term and long-term mortality and major complications were analyzed with multivariate regression analysis and propensity score matched-pair analysis was used to yield two well-matched groups for further comparison. RESULTS: The patients who were managed with PAC more often received intraoperative vasoactive drugs dopamine (70.9% vs. 45.5%; P<0.001) and epinephrine (7.7% vs. 2.6%; P<0.001). In addition, costs for initial hospitalization were higher for PAC patients ($14,535 vs. $13,873, respectively, p = 0.004). PAC use was neither associated with the perioperative mortality or major complications, nor was it associated with long-term mortality and major adverse cardiac and cerebrovascular events. In addition, comparison between two well-matched groups showed no significant differences either in baseline characteristics or in short-term and long-term outcomes. CONCLUSIONS: There is no clear indication of any benefit or harm in managing CABG patients with PAC. However, use of PAC in CABG is more expensive. That is, PAC use increased costs without benefit and thus appears unjustified for routine use in CABG surgery.

Análise de custo-efetividade do reúso de cateteres de cinecoronariografia sob a perspectiva de uma instituição pública no Município do Rio de Janeiro, Brasil / Cost-effectiveness analysis on the reutilization of coronary artery catheters in a public hospital in Rio de Janeiro, Brazil / Análisis del coste-efectividad en la reutilización de catéteres bajo la perspectiva de una institución pública en la ciudad de Río de Janeiro, Brasil

O objetivo foi comparar a relação de custo-efetividade entre o uso de cateteres cardíacos novos com cateteres reprocessados sob a perspectiva de uma instituição pública federal. Foi elaborado um modelo analítico de decisão elaborado para estimar a razão de custo-efetividade entre duas estratégias de utilização de materiais para cateterismo cardíaco utilizando, como desfecho clínico, a ocorrência de reação pirogênica. Os custos foram estimados por coleta direta nos setores envolvidos e valorados em Real (R$) para o ano de 2012. A árvore de decisão foi construída com as probabilidades de pirogenia descritas em estudo clínico. O custo para o reúso foi de R$ 109,84, e, para cateteres novos, de R$ 283,43. A estratégia de reúso demonstrou ser custo-efetiva, e a razão de custo-efetividade incremental indicou que, para evitar um caso de pirogenia, serão gastos R$ 13.561,75. O estudo aponta o reúso de cateteres como uma estratégia de menor custo comparada ao uso exclusivo de cateteres novos e pode contribuir para a tomada de decisão dos gestores.

The aim of this study was to compare the cost-effectiveness ratio of new versus reprocessed coronary artery catheters in a Federal public hospital. This was an analytical decision-making model prepared to estimate the cost-effectiveness ratio between two strategies in the use of materials in coronary artery catheterization, with pyrogenic reaction as the clinical outcome. Costs were estimated using direct data collection in the respective catheterization services and expressed in Brazilian Reais (R$), with 2012 as the reference year. The decision-making tree was constructed with the probabilities of pyrogenic reaction as described in a clinical trial. The cost per catheter for reuse was R$ 109.84, as compared to R$ 283.43 for a new catheter. The reutilization strategy proved to be cost cost-effective, and the incremental cost-effectiveness ratio indicated that R$ 13,561.75 would be spent to avoid one case of pyrogenic reaction. The study identified reuse of coronary artery catheters as a lower cost strategy compared to the exclusive use of new catheters, thus potentially assisting decision-making by health administrators.

El objetivo fue comparar la relación coste-eficacia en la reutilización de catéteres cardíacos respecto a los nuevos, bajo la perspectiva de un servicio público. Se utilizó un modelo analítico con el objeto de estimar la relación coste-efectividad entre las dos estrategias para el uso de materiales en el cateterismo cardíaco, utilizando la ocurrencia de reacción pirogénica como resultados clínicos. Los costes fueron estimados por la recogida directa en los sectores implicados y se expresan en reales (R$) para el año 2012. Un diagrama de decisiones se construyó con las probabilidades pirogénicas descritas en el estudio clínico. El coste de la reutilización era de R$ 109,84 y de R$ 283,43 por catéteres nuevos. La estrategia de reutilización ha demostrado ser coste-efectiva y la tasa de coste-efectividad incremental indicó que para prevenir un caso pirogénico se gastarían R$ 13,561.75. El estudio demuestra que la reutilización de catéteres es una estrategia de menor coste, en comparación con el uso exclusivo de los nuevos catéteres, y puede contribuir a la toma de decisiones.