Cost-Effectiveness Analysis of Percutaneous Patent Foramen Ovale Closure Preventing Secondary Ischemic Stroke in Japan.

OBJECTIVES: Patent foramen ovale is a hemodynamically insignificant interatrial communication that may cause ischemic stroke. Percutaneous patent foramen ovale closure reduces the risk for recurrent ischemic stroke in patients with a history of cryptogenic ischemic stroke. This study evaluated the cost-effectiveness of patent foramen ovale closure against medical therapy in patients after their first cryptogenic ischemic stroke in Japan. MATERIALS AND METHODS: The cost-effectiveness of patent foramen ovale closure compared with medical therapy was evaluated using the Markov model. The target patients started with patent foramen ovale closure or medical therapy for preventing secondary ischemic stroke under a stable state. Quality-adjusted life year was used as the outcome of effectiveness, and the analysis was conducted with a discount rate of 2% applied to both cost and effectiveness. The results of a multicenter open-label randomized controlled trial (RESPECT trial) evaluating patent foramen ovale closure using the Amplatzer™ PFO Occluder were used as clinical evidence. Cost-effectiveness was evaluated using the incremental cost-effectiveness ratio. It was evaluated as cost-effective if it was lower than 5 million JPY/ quality-adjusted life year. RESULTS: Patent foramen ovale closure was dominant over medical therapy by 2.53 quality-adjusted life years and an estimated cost reduction of 2,353,926 JPY. The probability of patent foramen ovale closure being dominant was 82.9%. CONCLUSIONS: Patent foramen ovale closure was dominant over medical therapy for preventing secondary ischemic stroke in patients with cryptogenic ischemic stroke.

Left Atrial Appendage Occlusion: Past, Present and Future.

There are several situations whereby oral anticoagulation may be unsuitable for stroke prevention in patients with atrial fibrillation (AF). Percutaneous left atrial appendage (LAA) occlusion has received much attention in this area. Various devices have already been developed and tested for this purpose. Data from registries and cohort studies have indicated favourable short- and long-term outcomes with LAA occlusion, and several international guidelines recommend its use in AF patients with contraindications to oral anticoagulation. However, prospective controlled trials in this very population are lacking. Furthermore, while modelling studies on cost analyses have suggested that LAA occlusion may be a cost-effective strategy compared with standard medical therapy, these have not been performed in high-risk patients who may have limited survival in the medium to long term. Thus, while LAA occlusion offers promise, there is a strong need for additional research to investigate its exact role, its long-term outcomes and cost efficacy.

Percutaneous Device Closure of Congenital Isolated Ventricular Septal Defects: A Single-Center Retrospective Database Study Amongst 412 Cases.

To identify suitable cases and reduce failure/complication rates for percutaneous ventricular septal defect (VSD) closure, we aimed to (1) study causes of device failure and (2) compare outcomes with different VSD types and devices in a high-volume single center with limited resources. Retrospective data of 412 elective percutaneous VSD closure of isolated congenital VSDs between 2003 and 2017 were analyzed. Out of 412, 363 were successfully implanted, in 30 device implantation failed, and in 19 the procedure was abandoned. Outcome was assessed using echocardiography, electrocardiography, and catheterization data (before procedure, immediately after and during follow-up). Logistic regression analyses were performed to assess effects of age, VSD type, and device type and size on procedural outcome. Median [interquartile range] age and body surface area were 6.6 [4.1-10.9] years and 0.7 [0.5-1.0] m2, respectively. Device failure was not associated with age (p = 0.08), type of VSD (p = 0.5), device type (p = 0.2), or device size (p = 0.1). Device failure occurred in 7.6% of patients. As device type is not related to failure rate and device failure and complication risk was not associated with age, it is justifiable to use financially beneficial ductal devices in VSD position and to consider closure of VSD with device in clinically indicated children.

Transesophageal echocardiography and fluoroscopy for percutaneous closure of atrial septal defects: A comparative study.

The aim of the study was to compare transesophageal echocardiography (TEE) and fluoroscopy for percutaneous atrial septal defect (ASD) closure.This was a retrospective analysis of children who underwent percutaneous ASD closure. The procedure was guided by TEE without fluoroscopy in 130 patients (TEE group) and by fluoroscopy in 163 patients (fluoroscopy group). Baseline demographic/clinical characteristics were recorded. Patients were followed until hospital discharge. Outcomes were procedure duration, peri/postoperative complications, hospital stay, and costs.The TEE and fluoroscopy groups showed no significant differences in age (71.7 ±â€Š40.7 vs 62.5 ±â€Š38.8 months), male/female ratio (54/76 vs 66/97), weight (22.0 ±â€Š12.0 vs 20.1 ±â€Š9.0 kg), ASD diameter (9.9 ±â€Š4.2 vs 9.3 ±â€Š3.9 cm), distances to the superior vena cava (13.4 ±â€Š4.6 vs 13.3 ±â€Š4.2 cm), inferior vena cava (13.4 ±â€Š4.3 vs 13.9 ±â€Š4.1 cm) and atrial septal roof (12.1 ±â€Š4.0 vs 12.3 ±â€Š3.2 cm), or atrial septal size (38.2 ±â€Š6.2 vs 39.4 ±â€Š26.6 cm); distance to the mitral valve was greater in the TEE group (13.2 ±â€Š4.4 vs 11.3 ±â€Š3.9 cm; P < .001). The TEE and fluoroscopy groups showed no significant differences in occlusion device size (14.3 ±â€Š4.6 vs 13.8 ±â€Š4.0 cm) or sheath size (8.7 ±â€Š1.8 vs 8.7 ±â€Š0.9 cm), but procedure duration was shorter in the TEE group (21.5 ±â€Š14.6 vs 28.6 ±â€Š10.9 minutes; P < .001). Postoperative fever (>38°C) occurred less frequently in the TEE group than in the fluoroscopy group (0.8% vs 9.2%; P < .001); there were no significant differences for the other complications. No patient had postoperative residual shunt, occlusion device shedding/displacement, or pericardial effusion. The TEE group had longer hospital stay (3.2 ±â€Š0.6 vs 2.9 ±â€Š0.6 days; P < .001) and higher procedure cost (29,687 ±â€Š4218 vs 28,530 ±â€Š1668 CNY (China Yuan); P = .002) than the fluoroscopy group.TEE-guided percutaneous ASD closure can be used as an alternative to fluoroscopy-guided procedures and avoids the use of radiation or contrast agents.

Lower Hospital Charges and Societal Costs for Catheter Device Closure of Atrial Septal Defects.

Atrial septal defects (ASD) are among the most common congenital heart defects. As more ASDs are corrected by interventional catheterization instead of surgery, it is critical to understand the associated clinical and societal costs. The goal of this study was to use a national U.S. database to describe hospital charges and societal costs for surgical and catheter-based (ASD) closure. Retrospective review of hospital discharge data from the Kids' Inpatient Database from January 2010 to December 2012. The database was queried for admissions for <21 years old with ICD-9 procedure codes for surgical (35.51 or 35.61) or catheter (35.52) ASD closure; those with other cardiac conditions and/or additional cardiac procedures were excluded. Age, length of stay (LOS), and hospital charges and lost parental wages (societal costs) were compared between groups using t test or Mann-Whitney U test, as appropriate. Four hundred and eighty-six surgical and 305 catheter ASD closures were identified. LOS, hospital charges, and total societal costs were higher in surgical ASD compared to catheter ASD admissions (3.6 vs. 1.3 days, p < 0.001, $87,465 vs. $64,109, p < 0.001, and $90,000 vs. $64,966, p < 0.001, respectively). In this review of a large national inpatient database, we found that hospital and societal costs for surgical ASD closure are significantly higher than catheter ASD closure in the United States in the current era. Factors that likely contribute to this include longer LOS and longer post-operative recovery. Using "real-world" data, this study demonstrates a substantial cost advantage for catheter ASD closure compared to surgical.

Cost-Effectiveness of Percutaneous Closure of the Left Atrial Appendage in Atrial Fibrillation Based on Results From PROTECT AF Versus PREVAIL.

BACKGROUND: Randomized trials of left atrial appendage (LAA) closure with the Watchman device have shown varying results, and its cost effectiveness compared with anticoagulation has not been evaluated using all available contemporary trial data. METHODS AND RESULTS: We used a Markov decision model to estimate lifetime quality-adjusted survival, costs, and cost effectiveness of LAA closure with Watchman, compared directly with warfarin and indirectly with dabigatran, using data from the long-term (mean 3.8 year) follow-up of Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation (PROTECT AF) and Prospective Randomized Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation (PREVAIL) randomized trials. Using data from PROTECT AF, the incremental cost-effectiveness ratios compared with warfarin and dabigatran were $20 486 and $23 422 per quality-adjusted life year, respectively. Using data from PREVAIL, LAA closure was dominated by warfarin and dabigatran, meaning that it was less effective (8.44, 8.54, and 8.59 quality-adjusted life years, respectively) and more costly. At a willingness-to-pay threshold of $50 000 per quality-adjusted life year, LAA closure was cost effective 90% and 9% of the time under PROTECT AF and PREVAIL assumptions, respectively. These results were sensitive to the rates of ischemic stroke and intracranial hemorrhage for LAA closure and medical anticoagulation. CONCLUSIONS: Using data from the PROTECT AF trial, LAA closure with the Watchman device was cost effective; using PREVAIL trial data, Watchman was more costly and less effective than warfarin and dabigatran. PROTECT AF enrolled more patients and has substantially longer follow-up time, allowing greater statistical certainty with the cost-effectiveness results. However, longer-term trial results and postmarketing surveillance of major adverse events will be vital to determining the value of the Watchman in clinical practice.

Budget impact analysis of the percutaneous septal occluder for treatment of ostium secundum atrial septal defects in the Brazilian Unified National Health System.

The aim of this study was to perform a budget impact analysis on the adoption of percutaneous occlusion of ostium secundum atrial septal defects in the Brazilian Unified National Health System. Costs were collected using micro-costing technique from medical records for each treatment technique (conventional surgery versus percutaneous septal occluder) at a public federal hospital specialized in high-complexity cardiology. The analysis showed that expenditures associated with percutaneous occlusion were lower than with conventional surgery, and sensitivity analysis confirmed the cost reduction in several scenarios, showing a significant budget impact with a 30% adoption rate for the percutaneous occluder (savings of approximately 1.5 million dollars per year). The study indicates that the adoption of the percutaneous septal occluder would mean cost savings of approximately 3.5 million dollars for the Brazilian public health system.

Budget impact analysis of the percutaneous septal occluder for treatment of ostium secundum atrial septal defects in the Brazilian Unified National Health System / Análise do impacto orçamentário do uso de oclusor percutâneo septal para fechamento de comunicação interatrial no Sistema Único de Saúde / Análisis del impacto presupuestario en el uso del oclusor percutáneo septal para la oclusión de comunicación interauricular en el Sistema Único de Salud brasileño

The aim of this study was to perform a budget impact analysis on the adoption of percutaneous occlusion of ostium secundum atrial septal defects in the Brazilian Unified National Health System. Costs were collected using micro-costing technique from medical records for each treatment technique (conventional surgery versus percutaneous septal occluder) at a public federal hospital specialized in high-complexity cardiology. The analysis showed that expenditures associated with percutaneous occlusion were lower than with conventional surgery, and sensitivity analysis confirmed the cost reduction in several scenarios, showing a significant budget impact with a 30% adoption rate for the percutaneous occluder (savings of approximately 1.5 million dollars per year). The study indicates that the adoption of the percutaneous septal occluder would mean cost savings of approximately 3.5 million dollars for the Brazilian public health system.

O objetivo foi analisar o impacto orçamentário da incorporação do oclusor septal percutâneo para o tratamento de defeitos do septo atrial do tipo ostium secundum, sob a perspectiva do Sistema Único de Saúde brasileiro. Os custos foram coletados por microcusteio com base nos registros das intervenções terapêuticas (cirurgia convencional ou implante percutâneo de oclusor septal) realizadas em um hospital público federal especializado em cardiologia de alta complexidade. A análise identificou que os custos associados ao procedimento percutâneo de oclusor septal foram inferiores aos relacionados com a cirurgia convencional, a análise de sensibilidade confirmou a redução dos custos em diversos cenários e mostrou que o impacto no orçamento foi significativo a partir de uma taxa de incorporação de 30% do oclusor septal percutâneo pelo sistema de saúde (redução dos gastos em torno de 1,5 milhão de dólares por ano). O estudo indica que a adoção do implante percutâneo do oclusor septal pode representar uma economia de aproximadamente 3,5 milhões de dólares para o sistema de saúde brasileiro.

El estudio consistió en analizar el impacto presupuestario de la implementación del oclusor septal percutáneo para el tratamiento de defectos del tabique auricular del ostium secundum, desde la perspectiva del Sistema Único de Salud. Los costes incluidos en el modelo por la técnica de micro-coste se obtuvieron de los registros de las intervenciones terapéuticas (cirurgía convencional u oclusor septal percutáneo) en un hospital público federal, especializado en cardiología de alta complejidad. El análisis reveló que los costos asociados con el oclusor septal percutáneo fueron más bajos que los asociados con la cirugía convencional, un análisis de sensibilidad confirmó la reducción de costos en diferentes escenarios y mostró que el impacto fue significativo desde una tasa del 30% de incorporación del oclusor septal percutáneo por el sistema de salud (reducción en el gasto de alrededor de 1.5 millones de dolares por año). El estudio indica que la adopción del implante percutáneo del oclusor septal puede representar un ahorro de aproximadamente 3,5 millones de dólares anuales al sistema de salud brasileño.

Results of comparing transthoracic device closure and surgical repair with right infra-axillary thoracotomy for perimembranous ventricular septal defects.

OBJECTIVES: Transthoracic device closure (TTDC) and surgical repair with right infra-axillary thoracotomy (SRRIAT) are two main alternative minimally invasive approaches for restrictive perimembranous ventricular septal defect (VSD); however, few studies have compared them with each other in terms of effectiveness and cost. METHODS: Patients with perimembranous VSD undergoing TTDC or SRRIAT from January 2012 to July 2013 were reviewed in a comparative investigation between the two procedures. RESULTS: Success from the procedures was achieved in 30 TTDC (30/33, 91%) and 96 SRRIAT patients (100%). Operation duration in the TTDC group was significantly shorter than that of the SRRIAT group (115.8 ± 43.8 vs 175.6 ± 41.3 min, P < 0.01). The total perioperative drainage, use of red blood cells, mechanical ventilation time, stay in the intensive care unit and hospital stay for the TTDC group were significantly less than those in the SRRIAT group. No deaths or complete atrioventricular block occurred in either group. One SRRIAT patient accepted a second surgery for residual shunt. TTDC costs slightly more than SRRIAT (40270.6 ± 2741.3 renmingbi [RMB] vs 32964.5 ± 8221.6 RMB, P < 0.01). CONCLUSIONS: Both TTDC and SRRIAT showed excellent outcomes and cosmetic appearance for suitable VSD candidates. Although its costs were higher, TTDC had the advantages over SRRIAT of a short operation duration and intensive care unit stay and fewer days in the hospital.

Cost effectiveness of percutaneous closure versus medical therapy for cryptogenic stroke in patients with a patent foramen ovale.

In patients with patent foramen ovales (PFOs) and cryptogenic stroke, observational studies have demonstrated reductions in recurrent neurologic events with transcatheter PFO closure compared with medical therapy. Randomized controlled trials and meta-analyses have shown a trend toward benefit with device closure. The cost-effectiveness of PFO closure has not been described. Therefore, a detailed cost analysis was performed using pooled weighted outcome and complication rates from published randomized controlled trials, Medicare cost tables, and wholesale medication prices. Incremental cost per life-year gained and per quality-adjusted life-year (QALY) gained by PFO closure was calculated. The commonly accepted cost-effectiveness threshold of <$50,000/quality-adjusted life-year gained was used. At 2.6 years (the mean duration of randomized controlled trial follow-up), PFO closure was more costly ($16,213, 95% confidence interval [CI] $15,753 to $16,749) per patient, with a cost of $103,607 (95% CI $5,826 to $2,544,750) per life-year gained. The expenditure to prevent 1 combined end point (transient ischemic attack, stroke, and death) at 2.6 years was $1.09 million (95% CI $1.04 million to $1.20 million). Modeling the costs of medical treatment prospectively, PFO closure reached cost-effectiveness (<$50,000/quality-adjusted life-year gained) at 2.6 years (95% CI 1.5 to 44.2). At 30.2 years (95% CI 28.2 to 36.2), the per patient mean cost of medical therapy exceeded that of PFO closure. In conclusion, PFO closure is associated with higher expenditures related to procedural costs; however, this increase may be offset over time by reduced event rates and costs of long-term medical treatment in patients who undergo transcatheter PFO closure. In younger patients typical of cryptogenic stroke, PFO closure may be cost effective in the long term.

Percutaneous device occlusion and minimally invasive surgical repair for perimembranous ventricular septal defect.

BACKGROUND: Percutaneous device occlusion and minimally invasive surgical repair for perimembranous ventricular septal defect (pmVSD) are two typical methods to reduce the invasiveness of the conventional operation through a median sternotomy. However, few studies have compared them in terms of effectiveness and cost. METHODS: Inpatients with isolated pmVSD who had undergone percutaneous device occlusion or minimally invasive surgical repair from June 2009 to June 2012 were reviewed for a comparative investigation between the two procedures. RESULTS: Procedure success was achieved in 80 percutaneous (93.0%) and in 113 surgical (98.3%) procedures (p=0.076). Percutaneous patients were older, with a smaller VSD size than surgical patients (16±11.7 vs 3.8±2.4 mm, p<0.001; 4.0±1.2 vs 4.3±1.3 mm, p=0.034, respectively). Major complications occurred in 1 percutaneous (1.2%) and in 4 surgical (3.5%) procedures (p=0.602), and minor complications occurred in 27 percutaneous (33.3%) and in 37 surgical (32.2%) procedures (p=0.991). The surgical repair cost 31% less than the device occlusion (¥20,565±¥3,497 vs ¥29,795±¥2,643, p<0.001), where most of the cost was attributed to the occluder in the amount of ¥19,500. CONCLUSIONS: Compared with device occlusion, minimally invasive surgical repair can provide comparable efficacy and complication rates. In addition, it is 31% cheaper than device occlusion. In low-income countries where health care resources are limited, medical resources must be judiciously allocated to the treatment that allows for effective treatment of the largest number of patients.

Long-term cost-effectiveness of transcatheter versus surgical closure of secundum atrial septal defect in adults.

BACKGROUND: The most common congenital anomaly in adults is secundum, which can be closed using a surgical or transcatheter approach. Despite the growing use of transcatheter ASD closure, few studies have examined the cost-effectiveness of this strategy. We sought to compare the long-term cost effectiveness of transcatheter and surgical closure of secundum in adults. METHODS: A decision-analytic model was used with all clinical outcome parameter estimates obtained from the province-wide Québec Congenital Heart Disease Database. Costs were obtained from a single academic centre (Canadian dollars). A cost-effectiveness analysis using a discrete event Monte Carlo simulation model from the perspective of a single third party payer and multiple sensitivity analyses were performed. Patients were followed for a maximum of 5 years after ASD closure. RESULTS: Between l998 and 2005, we identified 718 adults (n=335 transcatheter; n=383 surgical) who underwent ASD closure in Quebec. The 5-year cost of surgical closure was $15,304 SD $4581 versus $11,060 SD $5169 for the transcatheter alternative. At 5 years, transcatheter closure was marginally more effective than surgery (4.683 SD 0.379 life-years versus 4.618 SD 0.638 life-years). Probabilistic sensitivity analyses demonstrated that transcatheter ASD closure was a dominant strategy with an 80% probability of cost savings and equal or greater efficacy compared to surgical treatment. CONCLUSION: Although definitive conclusions are limited given the observational nature of the primary data sources, transcatheter ASD closure appeared to be a cost-effective strategy associated with slightly improved clinical outcomes and reduced costs compared to surgical closure at 5-years follow-up.

Comparison of immediate results and mid-term follow-up of surgical and percutaneous closure of ruptured sinus of Valsalva aneurysm.

BACKGROUND: The past decade has witnessed considerable improvement in implantation techniques for percutaneous closure of ruptured sinus of Valsalva aneurysm. This study was undertaken to compare the immediate results and mid-term follow-up of traditional surgery and percutaneous closure of ruptured sinus of Valsalva aneurysm in China. METHODS: Between January 1993 and January 2013, a total of 35 patients with ruptured sinus of Valsalva aneurysm were enrolled for attempted closure in our institution. Twenty patients (57.1%) underwent surgical repair and the other 15 patients (42.9%) underwent percutaneous closure. RESULTS: Nineteen patients (95.0%) in the surgical group had complete closure and 14 patients (93.3%) in the percutaneous closure group were treated successfully (p=0.681). Twelve patients with ruptured sinus of Valsalva aneurysm combined with subarterial ventricular septal defect (VSD) underwent surgical repair concomitantly. Two patients in the percutaneous closure group were treated for ruptured sinus of Valsalva aneurysm and perimembranous VSD using occluders concomitantly. One case of severe hemolysis developed 8h after the procedure in the percutaneous closure group. One death and one case of patch leak occurred in the surgical group during hospitalization. The time of hospital stay in the percutaneous closure group was shorter than that in the surgical group (p=0.004). The total medical cost of isolated ruptured sinus of Valsalva aneurysm in the percutaneous closure group was lower compared with that in the surgical group (p=0.046). During a median follow-up of 15 months (2-240 months), there were no deaths, infective endocarditis, device embolization, or malposition. CONCLUSIONS: Percutaneous closure is an attractive alternative to surgery in selected patients with ruptured sinus of Valsalva aneurysm for the better clinical advantages and economic benefits.

Cardi-O-Fix duct occluder versus Amplatzer duct occluder for closure of patent ductus arteriosus.

BACKGROUND: We sought to investigate the safety, efficacy, and follow-up results of percutaneous patent ductus arteriosus (PDA) closure using the novel Cardi-O-Fix duct occluder (CDO), a device similar to but less expensive than the Amplatzer duct occluder (ADO). We also aimed to compare these two devices in terms of results. METHODS: Between March 2005 and May 2012, 167 patients diagnosed with moderate-to-large PDA underwent transcatheter closure. ADO was used in 56 (33.5%) patients with a mean age of 8.1 ± 11.9 years (3.6 months-56 years), whereas CDO was used in 111 (66.5%) patients with a mean age of 12.6 ± 14.6 years (4.8 months-63 years). RESULTS: The narrowest PDA diameter, the used device diameter, procedure time, fluoroscopy time, and residual shunt rates were similar between the two groups. Procedural success rate was 100% in both groups. Although the residual shunt rate was higher in the CDO group immediately after the procedure, the difference was not statistically significant (12.6 vs. 8.9%; P = 0.3). There was no statistically significant difference between groups at discharge and during follow-up. No deaths occurred in any of the groups, and there were no differences in complication rates during the short- and mid-term follow-up periods (CDO 7/111 vs. ADO 5/56; P = 0.5 π). CONCLUSION: The CDO can be used for PDA closure because of its safety, effectiveness, and simplicity in use. It is available in bigger sizes and can be used in patients with large defects. According to our short- and mid-term findings, the results it yields are similar to those of the ADO; thus, it may be the preferred choice owing to its low cost and large size variability.

Closure of perimembranous ventricular septal defects with intraoperative device technique: another safe alternative to surgical repair.

OBJECTIVES: This study aims at assessing the safety and feasibility of intraoperative device closure of the perimembranous ventricular septal defect (VSD). METHODS: Total 89 patients in group I with intraoperative device closure and 58 in group II with surgical repair were enrolled in our hospital to participate in the study from January 2009 to December 2010. In group I, the approach involved a minimal inferior median incision that was performed after full evaluation of the perimembranous VSD by real-time transesophageal echocardiographic guidance, and the insertion of an asymmetric or a symmetric domestically made device was used to occlude the perimembranous VSD. RESULTS: In group I, 83 patients were occluded successfully under this approach. The size of the occluder implanted ranged from 6 to 14 mm. Complete atrioventricular block occurred in one case and Mobitz type II atrioventricular block occurred in one case during the procedure. One patient presented complete atrioventricular block one week after the operation. Two patients converted to surgical repair because of severe intraoperative aortic valve regurgitation. One patient with significant residual shunt transformed to surgical treatment. In our comparative studies, patients in group II experienced significantly longer operative time, ICU stay, and hospital stay (p < 0.001). The cost of group I was less than that of group II (p < 0.001). CONCLUSIONS: Minimally invasive transthoracic device closure of the perimembranous VSD with an asymmetric or a symmetric domestically made device without cardiopulmonary bypass is safe and feasible. It should be considered an acceptable alternative to surgery in selected subgroups. However, it is necessary to evaluate the long-term results.

Comparison of results and economic analysis of surgical and transcatheter closure of perimembranous ventricular septal defect.

OBJECTIVES: The last decade has witnessed considerable improvement in design and implantation techniques for the percutaneous closure of perimembranous ventricular septal defects. This study was undertaken to compare the results and economic analysis of traditional surgery and percutaneous closure with a modified double-disk occluder during hospitalization. METHODS: A total of 345 consecutive patients who underwent isolated perimembranous ventricular septal defect closure were identified between July 2009 and July 2011 in our institution. A total of 157 patients with perimembranous ventricular septal defect (45.5%) underwent percutaneous closure and the remaining 188 patients (54.5%) were treated surgically. RESULTS: In the percutaneous closure group, 156 patients (99.4%) had immediate complete closure and 186 (98.9%) in the surgical group were treated successfully (P = 0.671). The surgical group was significantly younger (P = 0.000) and larger in size (P = 0.000). One case of irreversible complete atrioventricular block and one death occurred in the surgical group. There was no significant difference in terms of hospital stay between the two groups. The total medical cost in the percutaneous closure group was lower compared with that in the surgical group (P = 0.005). Charges for medication, bed occupancy and nursing care of patients undergoing surgical closure were greater than those for patients undergoing transcatheter closure (P = 0.000, P = 0.000, P = 0.000, respectively). None of the patients in the percutaneous closure group required blood transfusion during hospitalization. Charges for radiography, lab and ultrasound in the percutaneous closure group were higher compared with those in the surgical group (P = 0.000, P = 0.000, respectively). CONCLUSIONS: Compared with surgical repair at our institution, the superior clinical outcomes and economic benefits of percutaneous closure are inspiring. Percutaneous closure is a valuable alternative to surgery and allows more patients to be effectively treated in China.

Cost-effectiveness of pharmacologic and invasive therapies for stroke prophylaxis in atrial fibrillation.

Atrial fibrillation is an abnormal heart rhythm characterized by rapid, disorganized activation (fibrillation) of the left and right atria of the heart, and is responsible for 15% of 700,000 strokes in the United States each year. There are multiple pharmacologic and nonpharmacologic therapies used for stroke prevention in atrial fibrillation, including vitamin K antagonists such as warfarin, antiplatelet agents such as aspirin and clopidogrel, and newer agents such as dabigatran, rivaroxaban and apixaban. Nonpharmacologic therapies involve excluding the left atrial appendage from the systemic circulation by surgical ligation or excision, percutaneous ligation, or endovascular implantation of a left atrial occlusion device. Because atrial fibrillation-related stroke is preventable, a comparison of the value of these interventions by cost-effectiveness analysis (CEA) could inform clinical and health policy recommendations. In this article, we review the principles of CEA and identify 11 articles that examine CEA of stroke prophylaxis strategies in atrial fibrillation. Although most studies evaluate aspirin and warfarin across a variety of atrial fibrillation stroke risk profiles, we also review new literature on new pharmacologic therapies such as direct thrombin inhibitors and discuss the potential value of device-based therapies.

Comparison of long-term clinical outcomes and costs between video-assisted thoracoscopic surgery and transcatheter amplatzer occlusion of the patent ductus arteriosus.

The current study was designed to compare long-term clinical outcomes and costs between video-assisted thoracoscopic surgery (VATS) and transcatheter Amplatzer occlusion (TAO). This study enrolled 294 patients with isolated patent ductus arteriosus (PDA) from April 2002 to April 2007, and 290 of these patients were followed up until April 2010. Of the 294 patients, 196 underwent VATS and 98 accepted TAO for PDA closure. The two groups were similar in terms of demographics and preoperative clinical characteristics. No cardiac deaths occurred in either group. All the patients in the VATS group had successful PDA closure, and 94 patients (94/98, 95.9%) in the TAO group had successful PDA occlusion. The incidence of acute procedure-related complications recorded was 1.5% in the VATS group compared with 10.2% in TAO group (P < 0.05). The cost per patient was $1,309.40 ± $312.20 in the VATS group and $3,415.80 ± $637.30 in the TAO group (P < 0.05). There were no cardiac deaths or newly occurring arrhythmias in either group during the fellow-up period. Up to the latest follow-up, no late recanalization or residual shunting was documented, and heart structure returned to normal level in the VATS group. However, residual shunting was detected in four more TAO patients. This study confirmed the long-term safety and efficacy of VATS clipping of PDA. Compared with TAO, PDA interrupted with VATS can achieve both excellent clinical results and satisfying cost effectiveness. The cost for VATS is only a little more than one third the cost for TAO.

Intraoperative device closure of atrial septal defects with inferior vena cava rim deficiency: a safe alternative to surgical repair.

OBJECTIVE: Our objective was to evaluate the safety and feasibility of intraoperative device closure of atrial septal defects with inferior vena cava rim deficiency. METHODS: From January 2005 to December 2008, we enrolled 65 patients who had a secundum atrial septal defect with inferior vena cava rim deficiency closure in our institution. Patients were divided into 2 groups: 35 patients in group I underwent intraoperative device closure with a right lateral minithoracotomy and 30 in group II underwent open cardiac repair with a right lateral thoracotomy and cardiopulmonary bypass. Intraoperative device closure involved a minimal intercostal incision that was performed after full evaluation of the atrial septal defect by transthoracic echocardiography and the insertion of the device through the delivery sheath to occlude the atrial septal defect. RESULTS: The procedure was successful in all patients. In group I, the diameter of the atrial septal defect ranged from 30 to 44 mm (mean, 35.3 ± 3.9 mm), and the size of the implanted occluder ranged from 34 to 48 mm (mean, 40 ± 2.1 mm). The total occlusion rate was 82.9% immediately after the operation, 97.1% at 3 months, and 100% at 12 and 24 months of follow-up. In group II, all patients had successful closure. A follow-up period of 12 to 24 months was obtained in both groups. During the follow-up, there was no recurrence, thrombosis, or device failure. In our comparative studies, group II had significantly longer operative time, intensive care unit stay, and hospital stay than group I (P < .001). The cost of group I was less than that of group II (20,450.9 ± 840.8 RMB vs 25,884.9 ± 701.8; P < .001). CONCLUSIONS: Intraoperative device closure of atrial septal defects with inferior vena cava rim deficiency is a safe and feasible technique. It has the advantages of cost savings, cosmetic results, and less trauma than surgical closure. Early and midterm results are encouraging.