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.

Cost effectiveness and clinical efficacy of patent foramen ovale closure as compared to medical therapy in cryptogenic stroke patients: A detailed cost analysis and meta-analysis of randomized controlled trials.

BACKGROUND: Up to half the patients with cryptogenic stroke under the age of 55 years have been found to have a PFO. Observational studies have demonstrated a benefit from closure of PFO and several RCTs have shown a trend toward benefit. The cost and clinical effectiveness of PFO closure is unclear. METHODS AND RESULTS: We searched for RCTs of PFO closure in patients with cryptogenic stroke and performed a detailed cost analysis and meta-analysis of treatment outcomes based on the results of the meta-analysis. Five RCTs containing 3404 patients with cryptogenic stroke were included. Of these 1829 underwent PFO closure and 1611 received medical therapy. Mean follow-up was 4.0 years. PFO closure achieved cost effectiveness (<$50,000/Quality-adjusted life-year gained) 2.7 years (95% Confidence Interval (CI) 2.2-3.4) after closure. The incremental cost to prevent one combined end point (CEP, combined transient ischemic attack (TIA), stroke, and death) by PFO closure was $535,655(95% CI $458,329-$642,674). After 55.4 years (95%CI 51.1-60.5) of follow-up, the per patient total cost of medical therapy exceeded that of PFO closure. PFO closure demonstrated clinical efficacy with a decreased risk of CEP (pooled hazard ratio (HR = 0.43(95%CI 0.27-0.59))) and a decreased risk of stroke (HR = 0.29(95%CI 0.02-0.57)). CONCLUSIONS: In comparison to medical therapy alone, PFO closure appears to be cost-effective and clinically efficacious.

Influence of hospital volume on outcomes of percutaneous atrial septal defect and patent foramen ovale closure: a 10-years US perspective.

BACKGROUND: Contemporary data regarding percutaneous closure of atrial septal defect/patent foramen ovale (ASD/PFO) are lacking. We evaluated the current trends in utilization of ASD/PFO closure in adults and investigated the effect of annual hospital volume on in-hospital outcomes. METHODS: We queried the Nationwide Inpatient Sample between the years 2001 and 2010 using the International Classification of Diseases (ICD-9-CM) procedure code for percutaneous closure of ASD/PFO with device. Hierarchical mixed effects models were generated to identify the independent multivariate predictors of outcomes. RESULTS: A total of 7,107 percutaneous ASD/PFO closure procedures (weighted n = 34,992) were available for analysis. A 4.7-fold increase in the utilization of this procedure from 3/million in 2001 to 14/million adults in 2010 in US (P < 0.001) was noted. Overall, percutaneous ASD/PFO closure was associated with 0.5% mortality and 12% in-hospital complications. The utilization of intracardiac echocardiography (ICE) increased 15 fold (P < 0.001) during the study period. The procedures performed at the high volume hospitals [2nd (14-37 procedures/year) and 3rd (>38 procedures/year) tertile] were associated with significant reduction in complications, length of stay and cost of hospitalization when compared to those performed at lowest volume centers (<13 procedures/year). Majority (70.5%) of the studied hospitals were found to be performing <10 procedures/year hence deviating from the ACC/AHA/SCAI clinical competency guidelines. CONCLUSIONS: Low hospital volume is associated with an increased composite (mortality and procedural complications) adverse outcome following ASD/PFO closure. In the interest of patient safety, implementation of the current guidelines for minimum required annual hospital volume to improve clinical outcomes is warranted.

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.

Intra-cardiac echocardiography in atrial septal interventions: impact on hospitalization costs.

OBJECTIVE: Intra-cardiac echocardiography (ICE) is used to guide percutaneous interventions on the atrial septum. However, ICE catheters are expensive. We questioned the impact of the use of ICE catheters on hospitalization costs for patent foramen ovale (PFO) or atrial septal defect (ASD) closure. METHODS AND RESULTS: Patients, scheduled for atrial septal closure, were randomly selected to use the AcuNav catheter (Biosense Webster Inc, Diamond Bar, CA, US) on top of the standard procedure (three or two days of hospitalization, procedure with transoesophageal echocardiography (TEE) and general anaesthesia). The AcuNav catheter was provided for free and the total hospitalization cost for each patient was calculated by verification of the bills, sent to the patient and the national health insurance. This was compared with a fictive hospitalization cost when ICE alone would have been used (three or two days of hospitalization, procedure without TEE, and local anaesthesia). Feasibility and safety were also evaluated. Three PFOs and two ASDs were successfully closed (3F/2M, age 55 +/- 12 years). The total hospitalization cost for a standard closing procedure was EUR 9345 +/- 132 and EUR 9303 +/- 132 for three and two days of hospitalization, respectively. With a free ICE catheter and no general anaesthesia, hospitalization cost lowered to EUR 8464 +/- 131 and EUR 8422 +/-131, respectively. Cost saving would be EUR 881 +/- 3, but the price of a single-use ICE catheter varies between EUR 2000 and 2500. In all patients, adequate images were obtained and no complications related to the ICE catheter occurred. CONCLUSIONS: Single-use ICE catheters remain expensive in percutaneous ASD or PFO closure. However, general anaesthesia might be avoided, which could open a discussion on cost savings.

Patent foramen ovale closure without echocardiographic control: use of "standby" intracardiac ultrasound.

OBJECTIVES: Our aim was to develop a "standby intracardiac echocardiography" approach to patent foramen ovale (PFO) closures where intracardiac echocardiography (ICE) is only utilized where there are adverse features. BACKGROUND: Percutaneous closure of PFO is usually aided by transesophageal echocardiography or ICE. This may be unnecessary where anatomical features are straightforward. METHODS: Patients were excluded from standby ICE if they had adverse anatomical features on their diagnostic transoesophageal echocardiogram, a device other than Amplatzer (AGA Medical, Plymouth, Minnesota), STARflex (NMT Medical, Boston, Massachusetts), or BioSTAR (NMT Medical) were to be used, or they were in a clinical trial demanding ICE/transesophageal echocardiography. Procedurally, defect diameter >15 mm on balloon sizing and tunnel length >12 mm warranted ICE guidance. RESULTS: Between April 2006 and October 2007, 124 patients underwent PFO closure. Fifty-four were excluded from standby ICE due to trial protocols (n = 22), hybrid atrial septal defect/PFO (n = 6), additional defect (n = 4), exuberant aneurysm (n = 3), or other device (n = 19, all HELEX, Gore Medical, Flagstaff, Arizona). The remaining 70 patients were age 38.1 +/- 6.4 years, 49% men. Primary indication for PFO closure was stroke (n = 46, 65%), transient ischemic attack (n = 22, 31%), or decompression illness (n = 2, 3%). Sixty-four (91%) underwent contrast fluoroscopic PFO closure alone. Six patients (9%) converted to ICE-controlled closure: PFO sized to >15 mm (n = 2); difficulties crossing PFO (n = 2), or long tunnel requiring transseptal puncture (n = 2). All 70 patients had procedural success without significant complications. Procedure duration and cost favored standby ICE. CONCLUSIONS: PFO closure can, in the majority of cases, be performed safely using contrast media and fluoroscopy alone. Standby ICE facilitates closure in the remaining patients during the index procedure.