RESUMO
RATIONALE AND OBJECTIVES: Bleeding is a major complication of transbronchial lung cryobiopsy (TBLC), and pre-placing a bronchial balloon is one of the clinical practices used to prevent it, but with very weak evidence, which should be confirmed. This study aimed to conduct whether pre-placing a bronchial balloon in TBLC for diagnosing interstitial lung disease (ILD) is more safety. MATERIALS AND METHODS: In this prospective, single-center, randomized controlled trial, patients with suspected ILD were enrolled and randomly assigned to pre-placed balloon and none-pre-placed balloon groups. The primary outcome was incidence of moderate bleeding in each group. The secondary endpoints were the incidence of severe bleeding, pneumothorax, and other procedural complications. RESULTS: Exactly 250 patients were enrolled between August 2019 and March 2022, with 125 in each group. There were no significant differences in severe bleeding between the none-pre-placed balloon group and pre-placed balloon group (1.6% vs. 0.8%; adjusted p = 0.520), while more moderate bleeding occurred in the none-pre-placed balloon group (26.4% vs. 6.4%, adjusted p = 0.001), as well as more use of hemostatic drug (28.0% vs. 6.4%, adjusted p = 0.001). Three patients in the none-pre-placed balloon group used the bronchial balloon. More samples could be acquired in the pre-placed balloon group than in the none-pre-placed balloon group (3.8 ± 0.9 vs. 3.1 ± 0.9, p < 0.001). There were no significant differences in multidisciplinary discussion (MDD) between the two groups (89.6% vs. 91.2%, adjusted p = 0.182). CONCLUSION: A pre-placed bronchial balloon can reduce the incidence of moderate bleeding and increase the confidence of the bronchoscopists. However, it had no effect on increasing the diagnostic rate of MDD and reducing severe bleeding. REGISTRATION NUMBER: NCT04047667 ( www. CLINICALTRIALS: gov identifier).
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Broncoscopia , Criocirurgia , Doenças Pulmonares Intersticiais , Humanos , Masculino , Feminino , Doenças Pulmonares Intersticiais/diagnóstico , Doenças Pulmonares Intersticiais/patologia , Pessoa de Meia-Idade , Idoso , Estudos Prospectivos , Broncoscopia/métodos , Broncoscopia/efeitos adversos , Criocirurgia/métodos , Criocirurgia/efeitos adversos , Biópsia/métodos , Biópsia/efeitos adversos , Hemorragia/etiologia , Hemorragia/diagnóstico , Hemorragia/prevenção & controle , Pulmão/patologia , Brônquios/patologiaRESUMO
INTRODUCTION: Three recent randomised controlled trials have demonstrated that pulmonary vein isolation as an initial rhythm control strategy with cryoablation reduces atrial arrhythmia recurrence in patients with symptomatic paroxysmal atrial fibrillation (PAF) compared with antiarrhythmic drug (AAD) therapy. The aim of this study was to evaluate the cost-effectiveness of first-line cryoablation compared with first-line AADs for treating symptomatic PAF in an English National Health Service (NHS) setting. METHODS: Individual patient-level data from 703 participants with PAF enrolled into Cryo-FIRST (Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation), STOP AF First (Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation) and EARLY-AF (Early Aggressive Invasive Intervention for Atrial Fibrillation) were used to derive the parameters applied in the cost-effectiveness model (CEM). The CEM comprised a hybrid decision tree and Markov structure. The decision tree had a 1-year time horizon and was used to inform the initial health state allocation in the first cycle of the Markov model (40-year time horizon; 3-month cycle length). Health benefits were expressed in quality-adjusted life years (QALYs). Costs and benefits were discounted at 3.5% per year. Model outcomes were generated using probabilistic sensitivity analysis. RESULTS: The results estimated that cryoablation would yield more QALYs (+0.17) and higher costs (+£641) per patient over a lifetime than AADs. This produced an incremental cost-effectiveness ratio of £3783 per QALY gained. Independent of initial treatment, individuals were expected to receive ~1.2 ablations over a lifetime. There was a 45% relative reduction in time spent in AF health states for those initially treated with cryoablation. DISCUSSION: AF rhythm control with first-line cryoablation is cost effective compared with first-line AADs in an English NHS setting.
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Fibrilação Atrial , Criocirurgia , Humanos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/cirurgia , Análise Custo-Benefício , Medicina Estatal , Antiarrítmicos/efeitos adversos , Criocirurgia/efeitos adversos , Criocirurgia/métodosRESUMO
Postburned auricular keloids are a challenging problem for the patient and physician. We describe a successful combined treatment of a bulky postburn auricular keloid employing intralesional cryosurgery followed by multiple W-plasty. An EAR-Q pre- and postoperative patient-reported outcome assessments have revealed a significant improvement in all ear parameters of appearance, adverse effects, and quality of life. This combined treatment might be added to the armamentarium of possible treatment modalities for this perplexing problem.
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Queimaduras , Criocirurgia , Queloide , Humanos , Queloide/cirurgia , Queloide/patologia , Criocirurgia/efeitos adversos , Qualidade de Vida , Queimaduras/cirurgia , Medidas de Resultados Relatados pelo Paciente , Resultado do TratamentoRESUMO
BACKGROUND: Pectus excavatum is the most common congenital chest wall abnormality, with the Nuss procedure being the most commonly performed repair. Pain control is the predominant factor in the postoperative treatment of these patients. This study aims to compare the cost and outcomes of intercostal nerve cryoablation (INC) and thoracic epidural (TE) in patients undergoing the Nuss procedure. METHODS: A retrospective chart review was conducted at our institution for all patients who underwent the Nuss procedure for pectus excavatum from 2002 to 2020. Patients were stratified by pain management strategy, INC vs. TE. Chi-square and Fisher's exact were used to compare categorical variables. Wilcoxon tests were used to evaluate continuous variables and costs. RESULTS: A total of 158 patients were identified. Of these, 80.4% (N = 127) were treated with epidural, while 19.6% (N = 31) were treated with intercostal nerve cryoablation. The INC group had lower rates of PCA use (35.5% vs. 93.7%, p < 0.001), lower total morphine milligram equivalent requirement (27.0 vs. 290.8, p < 0.001), and shorter length of stay (3.2 days vs. 5.3 days, p < 0.001) compared to the TE group. INC was also associated with longer operative times (153.0 min vs. 89.0 min, p < 0.001). The total hospitalization cost for the INC group was higher compared to the TE group ($24,742.5 vs $21,621.9, p = 0.001). CONCLUSIONS: In patients undergoing the Nuss procedure, compared to thoracic epidural, INC was associated with lower opioid use and shorter length of stay but at the cost of longer operative time and increased hospitalization cost. LEVEL OF EVIDENCE: Treatment Study, Level III.
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Criocirurgia , Tórax em Funil , Parede Torácica , Humanos , Estudos Retrospectivos , Analgésicos Opioides , Tórax em Funil/cirurgia , Nervos Intercostais/cirurgia , Criocirurgia/efeitos adversos , Dor Pós-Operatória/etiologia , Dor Pós-Operatória/terapia , Procedimentos Cirúrgicos Minimamente Invasivos/métodosRESUMO
INTRODUCTION: Optimal occlusion of pulmonary vein (PV) is essential for atrial fibrillation (AF) cryoballoon ablation (CBA). The aim of the study was to investigate the performance of two different tools for the assessment of PV occlusion with a novel navigation system in CBA procedure. METHODS: In consecutive patients with paroxysmal AF who underwent CBA procedure with the guidance of the novel 3-dimentional mapping system, the baseline tool, injection tool and pulmonary venography were all employed to assess the degree of PV occlusion, and the corresponding cryoablation parameters were recorded. RESULTS: In 23 patients (mean age 60.0 ± 13.9 years, 56.5% male), a total of 149 attempts of occlusion and 122 cryoablations in 92 PVs were performed. Using pulmonary venography as the gold standard, the overall sensitivity, specificity of the baseline tool was 96.7% (95% confidence interval [CI] 90.0%-99.1%), and 40.5% (95% CI 26.0%-56.7%), respectively, while the corresponding value of the injection tool was 69.6% (95% CI 59.7%-78.1%), and 100.0% (95% CI 90.6%-100.0%), respectively. Cryoablation with optimal occlusion showed lower nadir temperature (baseline tool: -44.3 ± 8.4°C vs. -35.1 ± 6.5°C, p < .001; injection tool: -46.7 ± 6.4°C vs. -38.3 ± 9.2°C, p < .001) and longer total thaw time (baseline tool: 53.3 ± 17.0 s vs. 38.2 ± 14.9 s, p = .003; injection tool: 58.5 ± 15.5 s vs. 41.7 ± 15.2 s, p < .001) compared with those without. CONCLUSIONS: Both tools were able to accurately assess the degree of PV occlusion and predict the acute cryoablation effect, with the baseline tool being more sensitive and the injection tool more specific.
Assuntos
Fibrilação Atrial , Ablação por Cateter , Criocirurgia , Veias Pulmonares , Pneumopatia Veno-Oclusiva , Humanos , Masculino , Pessoa de Meia-Idade , Idoso , Feminino , Veias Pulmonares/diagnóstico por imagem , Veias Pulmonares/cirurgia , Resultado do Tratamento , Criocirurgia/efeitos adversos , Criocirurgia/métodos , Fibrilação Atrial/diagnóstico por imagem , Fibrilação Atrial/cirurgia , Ablação por Cateter/métodosRESUMO
BACKGROUND: There is growing evidence that partial nephrectomy (PN) and percutaneous cryoablation (PCA) yield comparable outcomes for patients with cT1a renal cell carcinoma (RCC), although the cost-effectiveness of both treatments still needs to be assessed. PURPOSE: To perform a cost-effectiveness analysis of PN and PCA for patients with cT1a RCC. MATERIALS AND METHODS: A decision analysis was created over a 5-year span from a healthcare payer's perspective computing expected costs and outcomes of PN and PCA in terms of quality-adjusted life-years (QALYs) and incremental cost-effectiveness (ICER). After each treatment, the following states were modelled using data from the recent literature: procedural complications, no evidence of disease (NED), local recurrence, metastases, and death from RCC- or non-RCC-related causes. Probabilistic and deterministic sensitivity analyses were performed. RESULTS: PCA and PN yielded health benefits of 3.68 QALY and 3.67 QALY. Overall expected costs were $20,491 and $26,478 for PCA and PN. On probabilistic sensitivity analysis, PCA was more cost-effective than PN in 84.78% of Monte Carlo simulations. PCA was more cost-effective until its complication risk was at least 38% higher than PN. PCA was more cost-effective than PN when (i) PCAs annual local recurrence risk was < 3.5% higher than that of PN in absolute values; (ii) PCAs annual metastatic risk was < 1.0% higher than that of PN; or (iii) PCAs annual cancer-specific mortality risk < 0.65% higher than that of PN. PCA remained cost-effective until its procedural cost is above $13,875. CONCLUSION: PCA appears to be more cost-effective than PN for the treatment of cT1a RCC, although the currently available evidence is of limited quality. PCA may be the better treatment strategy in the majority of scenarios varying procedural complications, recurrence, metastatic risk, and RCC-mortality in clinically plausible ranges. KEY POINTS: ⢠For patients with cT1a RCCs, PCA yields a comparable health benefit at lower costs compared to PN, making PCA the dominant and therefore more cost-effective treatment strategy over PN. ⢠PCA was more cost-effective than PN when (i) PCAs annual local recurrence risk was < 3.5% higher than PN in absolute values; (ii) PCAs annual metastatic risk was < 1.0% higher than PN; or (iii) PCAs annual cancer-specific mortality risk < 0.65% higher than PN. ⢠PCA is more cost-effective than PN for the treatment of cT1a RCC, and it remained so in the majority of scenarios varying procedural complications, recurrence, metastatic risk, and RCC mortality.
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Carcinoma de Células Renais , Criocirurgia , Neoplasias Renais , Humanos , Carcinoma de Células Renais/cirurgia , Carcinoma de Células Renais/secundário , Neoplasias Renais/cirurgia , Neoplasias Renais/patologia , Análise Custo-Benefício , Criocirurgia/efeitos adversos , Nefrectomia , Resultado do TratamentoRESUMO
BACKGROUND: Cryoballoon ablation (CBA) is an effective first-line treatment for symptomatic atrial fibrillation (AF), as recently demonstrated by three randomized trials. This sub-analysis of the Cryo Global Registry aims to examine current clinical practices of first-line CBA. METHODS: AF patients treated with first-line CBA were compared to CBA in antiarrhythmic drug (AAD)-refractory patients at 12 months. Efficacy was examined using time-to-first atrial arrhythmia recurrence following a 90-day blanking period. Healthcare utilization was evaluated by repeat ablations and hospitalizations. Disease burden was examined by assessing quality of life (QOL) and patients' reporting of symptoms. RESULTS: Of 1394 patients, 433 (31.1%) were treated with first-line CBA, which was more frequent in high-volume centers. Serious procedure-related adverse event rates were similar. Efficacy at 12 months was higher in the first-line group (87.8 vs. 81.6%, HRunadj 0.64 (95% CI 0.47-0.88); p < 0.01) regardless of the centers' CBA experience; when controlling for baseline characteristics, the difference was not significant (HRadj 0.87 (95% CI 0.56-1.37); p = 0.55). No difference was observed in repeat ablations and hospitalizations between cohorts. First-line patients experienced a larger mean reduction in symptoms and were prescribed AADs at a lower rate at 12-month follow-up (9.7 vs. 29.9%). QOL improved in both cohorts from baseline to 12 months with no significant difference between groups (p = 0.29). CONCLUSIONS: In this global real-world experience, first-line CBA in patients with symptomatic AF is effective, with a larger symptom reduction compared with CBA after AAD failure and without a difference in healthcare utilization at mid-term follow-up. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02752737.
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Fibrilação Atrial , Ablação por Cateter , Criocirurgia , Humanos , Antiarrítmicos/uso terapêutico , Efeitos Psicossociais da Doença , Criocirurgia/efeitos adversos , Aceitação pelo Paciente de Cuidados de Saúde , Qualidade de Vida , Recidiva , Resultado do TratamentoRESUMO
BACKGROUND: Intercostal nerve cryoablation with the Nuss procedure has been shown to decrease opioid requirements and hospital length of stay; however, few studies have evaluated the impact on complications and hospital costs. METHODS: A retrospective cohort study was performed for all Nuss procedures at our institution from 2016 through 2020. Outcomes were compared across 4 pain modalities: cryoablation with standardized pain regimen (n = 98), patient-controlled analgesia (PCA; n = 96), epidural (n = 36), and PCA with peripheral nerve block (PNB; n = 35). Outcomes collected included length of stay, opioid use, variable direct costs, and postoperative complications. Univariate and multivariate hierarchical regression analysis was used to compare outcomes between the pain modalities. RESULTS: Cryoablation was associated with increased total hospital cost compared with PCA (cryoablation, $11 145; PCA, $8975; P < .01), but not when compared with epidural ($9678) or PCA with PNB ($10 303). The primary driver for increased costs was operating room supplies (PCA, $2741; epidural, $2767; PCA with PNB, $3157; and cryoablation, $5938; P < .01). With multivariate analysis, cryoablation was associated with decreased length of stay (-1.94; 95% CI, -2.30 to -1.57), opioid use during hospitalization (-3.54; 95% CI, -4.81 to -2.28), and urinary retention (0.13; 95% CI, 0.05-0.35). CONCLUSIONS: Cryoablation significantly reduces opioid requirements and length of stay relative to alternative modalities, but it was associated with an increase in total hospital costs relative to PCA, but not epidural or PCA with PNB. Cryoablation was not associated with allodynia or slipped bars requiring reoperation.
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Analgesia Epidural , Criocirurgia , Tórax em Funil , Transtornos Relacionados ao Uso de Opioides , Humanos , Nervos Intercostais/cirurgia , Analgésicos Opioides/uso terapêutico , Estudos Retrospectivos , Dor Pós-Operatória/tratamento farmacológico , Criocirurgia/efeitos adversos , Criocirurgia/métodos , Tórax em Funil/cirurgia , Analgesia Epidural/métodosRESUMO
PURPOSE OF REVIEW: Atrial fibrillation is a growing public health problem and is associated with an increased risk of comorbidities with enormous socioeconomic implications. This review article focuses on fiscal burden of atrial fibrillation on the healthcare system and economic value of atrial fibrillation ablations brought to the patient and the payers by improvement in outcomes and reduction in treatment costs. RECENT FINDINGS: This article summarizes the recently published studies evaluating the economic impact of atrial fibrillation treatment. Catheter ablation have shown to be the most successful strategy for treatment of defibrillation. However, repeat ablation is associated with higher costs, over and above any subsequent procedural costs, compared with a single ablation procedure for atrial fibrillation. Cryoballoon ablation has been shown to have fewer repeat ablations than radiofrequency ablations, which resulted in overall cost reduction. Improvement in laboratory efficiency, better utilization of laboratory resources and same-day discharge strategy can lead to further healthcare savings and increase in value to all stakeholders. SUMMARY: The value of healthcare delivery for patient with atrial fibrillation can be improved by advancement in technology that demonstrates cost reduction to the health system and outcomes improvements. Implementation of tactics that decrease cost and improve outcomes can alleviate some of the financial strain on healthcare systems, which is of extreme importance in the current climate.
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Fibrilação Atrial , Ablação por Cateter , Criocirurgia , Fibrilação Atrial/terapia , Ablação por Cateter/métodos , Criocirurgia/efeitos adversos , Humanos , Resultado do TratamentoRESUMO
BACKGROUND: Pulmonary vein isolation (PVI) lesions after cryoballoon ablation (CBA) are characterized as a wider and more continuous than that after conventional radiofrequency catheter ablation (RFCA) without the contact force (CF)-sensing technology. However, the impact on the lesion characteristics of ablation with a CF-sensing catheter has not been well discussed. We sought to assess the lesions using late-gadolinium enhancement magnetic resonance imaging (LGE-MRI) and to compare the differences between the two groups (CB group vs. RF group). METHODS: A total of 30 consecutive patients who underwent PVI were enrolled (CB group, 18; RF group, 12). The RF applications were delivered with a target lesion size index (LSI) of 5. The PVI lesions were assessed by LGE-MRI 3 months after the PVI. The region around the PV was divided into eight segments: roof, anterior-superior, anterior carina, anterior inferior, bottom, posterior inferior, posterior carina, and posterior superior segment. The lesion width and visual gap of each segment were compared between the two groups. The visual gaps were defined as no-enhancement site of >4 mm. RESULTS: The mean LSI was 4.7 ± 0.7. The lesion width was significantly wider but the visual gaps were more frequently documented at the bottom segment of right PV in the CBA group (lesion width: 8.1 ± 2.2 vs. 6.3 ± 2.2 mm; p = .032; visual gap at the bottom segment or right PV: 39% vs. 0%; p = .016). CONCLUSIONS: The PVI lesion was wider after CBA, while the visual gaps were fewer after RFCA with a CF-sensing catheter.
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Fibrilação Atrial , Ablação por Cateter , Criocirurgia , Veias Pulmonares , Ablação por Radiofrequência , Fibrilação Atrial/diagnóstico por imagem , Fibrilação Atrial/cirurgia , Ablação por Cateter/efeitos adversos , Catéteres , Meios de Contraste , Criocirurgia/efeitos adversos , Gadolínio , Humanos , Imageamento por Ressonância Magnética , Veias Pulmonares/diagnóstico por imagem , Veias Pulmonares/cirurgia , Ablação por Radiofrequência/efeitos adversos , Resultado do TratamentoRESUMO
PURPOSE: To evaluate the cost effectiveness of incorporating cryoablation in the treatment regimens for uncomplicated bone metastases using radiation therapy (RT) in single-fraction RT (SFRT) or multiple-fraction RT (MFRT) regimens. MATERIALS AND METHODS: A Markov model was constructed using 1-month cycles over a lifetime horizon to compare the cost effectiveness of multiple strategies, including RT followed by RT (RT-RT) for recurrent pain, RT followed by cryoablation (RT-ablation), and cryoablation followed by RT (ablation-RT). RT-RT consisted of 8 Gy in 1 fraction/8 Gy in 1 fraction (SFRT-SFRT) and 30 Gy in 10 fractions/20 Gy in 5 fractions (MFRT-MFRT). Probabilities and utilities were extracted from a search of the medical literature. Costs were calculated from a payer perspective using 2017 Medicare reimbursement in an outpatient setting. Incremental cost effectiveness ratios (ICERs) were calculated using strategies evaluated for willingness-to-pay threshold of $100,000 per quality-adjusted life-year (QALY). To account for model uncertainty, one-way and probabilistic sensitivity analyses were performed. RESULTS: In the base case analysis, SFRT-ablation was cost effective relative to SFRT-SFRT at $96,387/QALY. MFRT-ablation was cost effective relative to MFRT-MFRT at $85,576/QALY. Ablation-SFRT and ablation-MFRT were not cost effective with ICERs >$100,000/QALY. In one-way sensitivity analyses, results were highly sensitive to variation in multiple model parameters, including median survival (base: 9 months), with SFRT-SFRT favored at median survival ≤8.7 months. Probabilistic sensitivity analysis examining SFRT-based regimens showed that SFRT-ablation was preferred in 36.9% of simulations at WTP of $100,000/QALY. CONCLUSIONS: Cryoablation is a potentially cost-effective alternative to reirradiation with RT for recurrent of pain following RT; however, no strategy incorporating initial cryoablation was cost effective.
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Neoplasias Ósseas/terapia , Criocirurgia/economia , Custos de Cuidados de Saúde , Cuidados Paliativos/economia , Cirurgia Assistida por Computador/economia , Neoplasias Ósseas/diagnóstico por imagem , Neoplasias Ósseas/mortalidade , Neoplasias Ósseas/secundário , Redução de Custos , Análise Custo-Benefício , Criocirurgia/efeitos adversos , Fracionamento da Dose de Radiação , Humanos , Cadeias de Markov , Modelos Econômicos , Anos de Vida Ajustados por Qualidade de Vida , Radioterapia/economia , Ensaios Clínicos Controlados Aleatórios como Assunto , Retratamento/economia , Cirurgia Assistida por Computador/efeitos adversos , Fatores de Tempo , Resultado do TratamentoRESUMO
INTRODUCTION: One cause of cerebral infarction during cryoballoon ablation is the entry of air into a sheath due to the use of inappropriate catheters. It is known that the left atrial pressure of patients with obstructive sleep apnea syndrome can be negative. However, the effects of catheter selection and negative pressure changes in the sheath on air intrusion are not yet well understood. The aim of this study was to evaluate how catheter selection and negative pressure changes affect air intrusion and to perform countermeasures for air intrusion. METHODS AND RESULTS: This experiment used siphon principle to create negative pressure in the sheath. Noncryoablation catheters (not designed exclusively for cryoballoon ablation) and cryoballoon catheters were investigated. Catheters were inserted into the sheath and then removed. Thereafter, the amount of air in the sheath was measured. For catheters producing significantly larger amounts of air intrusion, the catheters were inserted via a long sheath in the sheath (sheath-in-sheath technique) and the same procedures were repeated. We found that the amount of air intrusion through most of the noncryoablation catheters was significantly larger than that through cryoablation catheters. An increase in the magnitude of negative pressure in the sheath resulted in a proportional increase in air intrusion, but the sheath-in-sheath technique significantly reduced air intrusion. CONCLUSION: The amount of air intrusion increased when using catheters with complicated tip shapes and thin outer diameters and when the magnitude of negative pressure in the sheath increased. The sheath-in-sheath technique may be an effective countermeasure.
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Cateterismo Cardíaco/instrumentação , Cateteres Cardíacos , Criocirurgia/instrumentação , Embolia/prevenção & controle , Função do Átrio Esquerdo , Pressão Atrial , Cateterismo Cardíaco/efeitos adversos , Criocirurgia/efeitos adversos , Embolia/etiologia , Embolia/fisiopatologia , Desenho de Equipamento , Humanos , Teste de Materiais , Fatores de RiscoRESUMO
AIMS: The goals of this study were to develop a method that combines cryoablation with real-time magnetic resonance imaging (MRI) guidance for pulmonary vein isolation (PVI) and to further quantify the lesion formation by imaging both acute and chronic cryolesions. METHODS AND RESULTS: Investigational MRI-compatible cryoablation devices were created by modifying cryoballoons and cryocatheters. These devices were used in canines (n = 8) and a complete series of lesions (PVI: n = 5, superior vena cava: n = 4, focal: n = 13) were made under real-time MRI guidance. Late gadolinium enhancement (LGE) magnetic resonance imaging was acquired at acute and chronic time points. Late gadolinium enhancement magnetic resonance imagings show a significant amount of acute tissue injury immediately following cryoablation which subsides over time. In the pulmonary veins, scar covered 100% of the perimeter of the ostium of the veins acutely, which subsided to 95.6 ± 4.3% after 3 months. Focal point lesions showed significantly larger acute enhancement volumes compared to the volumes estimated from gross pathology measurements (0.4392 ± 0.28 cm3 vs. 0.1657 ± 0.08 cm3, P = 0.0043). Additionally, our results with focal point ablations indicate that freeze-zone formation reached a maximum area after 120 s. CONCLUSION: This study reports on the development of an MRI-based cryoablation system and shows that with acute cryolesions there is a large area of reversible injury. Real-time MRI provides the ability to visualize the freeze-zone formation during the freeze cycle and for focal lesions reaches a maximum after 120 s suggesting that for maximizing lesion size 120 s might be the lower limit for dosing duration.
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Criocirurgia , Imagem por Ressonância Magnética Intervencionista , Veias Pulmonares/cirurgia , Veia Cava Superior/cirurgia , Animais , Criocirurgia/efeitos adversos , Cães , Imagem por Ressonância Magnética Intervencionista/efeitos adversos , Veias Pulmonares/diagnóstico por imagem , Veias Pulmonares/patologia , Fatores de Risco , Fatores de Tempo , Veia Cava Superior/diagnóstico por imagem , Veia Cava Superior/patologiaRESUMO
AIMS: We investigated safety and efficacy of a high throughput atrial fibrillation (AF) ablation service within a local non-cardiac centre compared with matched patients at the regional tertiary cardiac centre. METHODS AND RESULTS: Patients were consented in clinic and pre-assessed by clerical staff. Locally, other than physicians, staff had no experience of ablation and were trained with simulations. Pulmonary vein isolation (PVI) was performed with conscious sedation, on uninterrupted anticoagulation for at least 4 weeks. No transoesophageal echocardiogram (TOE) was performed. A 28 mm Arctic Front Advance Cryoballoon was used. A 20 mm Achieve wire demonstrated PVI on a portable laptop-based EP recording system. Phrenic nerve function was monitored during right PVI. Finally, a transthoracic echocardiogram excluded a pericardial effusion. A Femostop was applied. Two hundred and seventy-six patients were matched. Average age was 61 ± 0.7 years, 39% female. CHA2DS2 VASc score varied from 0 to 7. Procedure time was significantly shorter at the local hospital (63.5 ± 1.1 vs. 101.7 ± 2.9 min, P < 0.0001). Fluoroscopy time (5.5 ± 0.2 vs. 12.6 ± 0.6 min, P < 0.0001) and fluoroscopy dose were lower (17.2 ± 2.1 vs. 97.6 ± 14.6 mGy, P < 0.0001). Successful PVI was achieved in all. The complication rate was low (5.4% vs. 6.3%, P = not significant). Four (1.4%) patients were not day case discharges. At 3 month follow-up, 54.3% had complete resolution, and 26.1% had improvement of symptoms. A total of 16.6% patients requested repeat procedures for ongoing symptoms. CONCLUSION: In experienced hands, cryoballoon for paroxysmal AF is delivered safely and effectively in a local centre. Outcomes remain excellent. These short, day case procedures allow utilization of non-cardiac centres. The service provides a model to meet increasing demands.
Assuntos
Procedimentos Cirúrgicos Ambulatórios , Fibrilação Atrial/cirurgia , Criocirurgia , Hospitais com Alto Volume de Atendimentos , Hospitais com Baixo Volume de Atendimentos , Veias Pulmonares/cirurgia , Centros de Atenção Terciária , Procedimentos Cirúrgicos Ambulatórios/efeitos adversos , Anticoagulantes/administração & dosagem , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Sedação Consciente , Criocirurgia/efeitos adversos , Feminino , Necessidades e Demandas de Serviços de Saúde , Humanos , Tempo de Internação , Masculino , Auditoria Médica , Pessoa de Meia-Idade , Duração da Cirurgia , Alta do Paciente , Segurança do Paciente , Complicações Pós-Operatórias/etiologia , Estudos Prospectivos , Veias Pulmonares/fisiopatologia , Recidiva , Reoperação , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES: This study sought to evaluate the sensitivity of noninvasive imaging in the assessment of severely stenosed and occluded pulmonary veins, and examine clinical outcomes following percutaneous intervention. BACKGROUND: PV stenosis (PVS) is a rare complication of atrial fibrillation ablation, but is associated with significant morbidity. Patients present with nonspecific pulmonary symptoms that can result in delayed diagnosis and progression to PV occlusion. The assessment and management of PV occlusion has rarely been described. METHODS: This was a prospective observational study performed from 2000 to 2014. RESULTS: Computed tomography identified 124 patients with severe PVS, including 46 patients with at least 1 occluded vein. Patients with PV occlusion more frequently presented with cough (64.1% vs. 32.8%; p = 0.002) and hemoptysis (39.1% vs. 14.1%; p = 0.0015) and were more likely to have pulmonary parenchymal consolidation (77.3% vs. 41.7%; p = 0.0002). Intervention was attempted in 65 occluded veins and a residual microchannel was identified in 22 (34.0%). Balloon angioplasty was performed in 11, and 11 were treated with stenting. Over 3 years the rates of restenosis were similar for patients with PVS and PV occlusion (47.0% vs. 35.0%; p = 0.24). Among patients with PV occlusion, stenting significantly reduced the rate of restenosis (hazard ratio: 3.97; 95% confidence interval: 1.14 to 13.85; p = 0.03). CONCLUSIONS: Veins deemed occluded on noninvasive imaging require invasive characterization, as residual microchannels may be present in one-third of patients. In patients with a microchannel, intervention can be performed with either balloon angioplasty or stenting. Recurrence remains a common problem; however, stenting significantly reduces the rate of subsequent restenosis.
Assuntos
Angioplastia com Balão , Fibrilação Atrial/cirurgia , Ablação por Cateter/efeitos adversos , Angiografia por Tomografia Computadorizada , Criocirurgia/efeitos adversos , Flebografia/métodos , Estenose de Veia Pulmonar/diagnóstico por imagem , Estenose de Veia Pulmonar/cirurgia , Adulto , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/instrumentação , Fibrilação Atrial/diagnóstico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Estudos Prospectivos , Recidiva , Fatores de Risco , Estenose de Veia Pulmonar/etiologia , Estenose de Veia Pulmonar/fisiopatologia , Stents , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução VascularRESUMO
PURPOSE: To evaluate perioperative outcomes of thermal ablation with microwave (MW), radiofrequency (RF), and cryoablation for stage T1c renal cell carcinoma (RCC). MATERIALS AND METHODS: A retrospective analysis of 384 patients (mean age, 71 y; range, 22-88 y) was performed between October 2006 and October 2016. Mean radius, exophytic/endophytic, nearness to collecting system or sinus, anterior/posterior, and location relative to polar lines; preoperative aspects and dimensions used for anatomic classification; and centrality index scores were 6.3, 7.9, and 2.7, respectively. Assessment of pre- and postablation serum blood urea nitrogen, creatinine, and estimated glomerular filtration rate was performed to assess functional outcomes. Linear regression analyses were performed to compare sedation medication dosages among the three treatment cohorts. Univariable and multivariable logistic regression analyses were performed to compare rates of residual disease and complications among treatment modalities. RESULTS: A total of 437 clinical stage T1N0M0 biopsy-proven RCCs measuring 1.2-6.9 cm were treated with computed tomography (CT)-guided MW ablation (n = 44; 10%), RF ablation (n = 347; 79%), or cryoablation (n = 46; 11%). There were no significant differences in patient demographic or tumor characteristics among cohorts. Complication rates and immediate renal function changes were similar among the three ablation modalities (P = .46 and P = .08, respectively). MW ablation was associated with significantly decreased ablation time (P < .05), procedural time (P < .05), and dosage of sedative medication (P < .05) compared with RF ablation and cryoablation. CONCLUSIONS: CT-guided percutaneous MW ablation is comparable to RF ablation or cryoablation for the treatment of stage T1N0M0 RCC with regard to treatment response and is associated with shorter treatment times and less sedation than RF ablation or cryoablation. In addition, the safety profile of CT-guided MW ablation is noninferior to those of RF ablation or cryoablation.
Assuntos
Carcinoma de Células Renais/cirurgia , Ablação por Cateter , Criocirurgia , Neoplasias Renais/cirurgia , Micro-Ondas/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Biópsia , Carcinoma de Células Renais/diagnóstico por imagem , Carcinoma de Células Renais/patologia , Ablação por Cateter/efeitos adversos , Criocirurgia/efeitos adversos , Feminino , Humanos , Hipnóticos e Sedativos/administração & dosagem , Neoplasias Renais/diagnóstico por imagem , Neoplasias Renais/patologia , Modelos Lineares , Modelos Logísticos , Masculino , Micro-Ondas/efeitos adversos , Pessoa de Meia-Idade , Análise Multivariada , Estadiamento de Neoplasias , Razão de Chances , Duração da Cirurgia , Complicações Pós-Operatórias/etiologia , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Tomografia Computadorizada por Raios X , Resultado do Tratamento , Adulto JovemRESUMO
OBJECTIVE: This study aimed to estimate the cost-effectiveness of Coblation compared with cold steel tonsillectomy in adult and paediatric patients in the UK. METHOD: Decision analysis was undertaken by combining published clinical outcomes with resource utilisation estimates derived from a panel of clinicians. RESULTS: Using a cold steel procedure instead of Coblation is expected to generate an incremental cost of more than £2000 for each additional avoided haemorrhage, and the probability of cold steel being cost-effective was approximately 0.50. Therefore, the cost-effectiveness of the two techniques was comparable. When the published clinical outcomes were replaced with clinicians' estimates of current practice, Coblation was found to improve outcome for less cost, and the probability of Coblation being cost-effective was at least 0.70. CONCLUSION: A best-case scenario suggests Coblation affords the National Health Service a cost-effective intervention for tonsillectomy in adult and paediatric patients compared with cold steel procedures. A worst-case scenario suggests Coblation affords the National Health Service an equivalent cost-effective intervention for adult and paediatric patients.
Assuntos
Criocirurgia/economia , Custos de Cuidados de Saúde/estatística & dados numéricos , Ablação por Radiofrequência/economia , Tonsilectomia/métodos , Adulto , Criança , Pré-Escolar , Auditoria Clínica , Análise Custo-Benefício , Criocirurgia/efeitos adversos , Criocirurgia/métodos , Humanos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Estudos Prospectivos , Ablação por Radiofrequência/efeitos adversos , Ablação por Radiofrequência/métodos , Tonsilectomia/efeitos adversos , Tonsilectomia/economia , Reino UnidoRESUMO
INTRODUCTION: Although noninferiority of cryoballoon ablation (CBA) and radiofrequency catheter ablation for antral pulmonary vein isolation (APVI) has been reported in patients with paroxysmal atrial fibrillation (PAF), it is not clear whether contact force sensing (CF-RFA) and CBA with the second-generation catheter have similar procedural costs and long-term outcomes. The objective of this study is to compare the long-term efficacy and cost implications of CBA and CF-RFA in patients with PAF. METHODS AND RESULTS: A first APVI was performed in 146 consecutive patients (age: 63 ± 10 years, men: 95 [65%], left atrial diameter: 42 ± 6 mm) with PAF using CBA (71) or CF-RFA (75). Clinical outcomes and procedural costs were compared. The mean procedure time was significantly shorter with CBA than with CF-RFA (98 ± 39 vs. 158 ± 47 minutes, P < 0.0001). Despite a higher equipment cost in the CBA than the CF-RFA group, the total procedure cost was similar between the two groups (P = 0.26), primarily driven by a shorter procedure duration that resulted in a lower anesthesia cost. At 25 ± 5 months after a single ablation procedure, 51 patients (72%) in the CBA, and 55 patients (73%) in the CF-RFA groups remained free from atrial arrhythmias without antiarrhythmic drug therapy (P = 0.84). CONCLUSIONS: The procedure duration was approximately 60 minutes shorter with CBA than CF-RFA. The procedural costs were similar with both approaches. At 2 years after a single procedure, CBA and CF-RFA have similar single-procedure efficacies of 72-73%.