Assessment of atrial septal defects using 3-dimensional transthoracic echocardiography prior to percutaneous device closure: first report from Bangladesh.

BACKGROUND: Secundum atrial septal defect (ASD) is treated following trans-catheter closure in alternative to surgical treatment. Per-intervention selection of device size with balloon occlusive diameter (BOD) often cause tearing or enlarging, causing arrhythmias and hypotension. We assessed the suitability of percutaneous device closure for ASD using 3-dimensional transthoracic echocardiography (3DTTE). OBJECTIVES: This study was conducted to investigate if 3DTTE could be an alternative of balloon sizing for selection of device size in atrial septal defect device closure. DESIGN: It was a cross-sectional comparative study. METHODS: This study was conducted at the department of Pediatric Cardiology, Bangabandhu Sheikh Mujib Medical University for a period of 2 years. Thirty-three purposively selected secundum ASD patients suitable for device closure were included in the study. Ethical permission was taken from the Institutional Review Board and written consent was taken from each patient's guardian. In this study, 3DTTE derived ASD diameter and BOD were compared with that of deployed device size using correlation analysis. RESULTS: Out of 33 patients, 63.6% were female and 36.4% were males had a mean age of 18.07 ± 14.58 years (range 2-55 years). Mean diameter of ASD measured by 2-dimensional (2D) and 3-dimensional (3D) echocardiography were 17.09 ± 6.08 mm and 21.30 ± 6.56 mm, respectively, yielding a significant difference (p < 0.001). 3D echocardiography derived ASDs diameter were highly correlated with device size than BOD and 2D echocardiography derived diameter (2D echocardiography: r = 0.796, p = <0.001, 3D echocardiography: r = 0.960, p = <0.001, BOD: r = 0.840, p = <0.001). CONCLUSION: 3DTTE can accurately measure ASD diameter and can be used as an alternate, effective, and safe method to select device size.

Appropriate selection of echocardiographic guidance for transcatheter atrial septal defect closure.

Transesophageal echocardiography (TEE) under general anesthesia (GA) or intracardiac echocardiography (ICE) under sedation is usually used for echocardiographic guidance during transcatheter atrial septal defect (ASD) closure. However, appropriate selection of guidance has not been fully established. Our study aimed to evaluate whether selection of guidance depending on anatomic ASD features and TEE tolerability under sedation contributes to procedure success. On the basis of anatomic ASD characteristics and TEE tolerability under sedation during the pre-procedural TEE, we selected either TEE, ICE, or combined TEE and ICE under moderate-to-deep sedation or TEE under GA for guidance. Anatomic characteristics of the defect, medical costs, complications, and primary outcomes for these four different types of guidance were analyzed. A total of 154 patients were classified into four guidance groups depending on the results of diagnostic TEE under sedation; 11 patients were scheduled for the procedure under GA in advance. Procedures were successfully completed in all but two patients in whom closure guided by TEE under sedation was attempted for an extremely large defect or extensive superior rim deficiency. Two patients who underwent TEE or combined TEE and ICE guidance under sedation were converted to ICE-only guidance due to desaturation or excessive body movement. Device dislodgement was not observed during the procedure or during median follow-up of 1188 days [interquartile range 577-1831]. Appropriate selection of guidance might contribute to successful transcatheter ASD closure.

Changes in blood volume shunting in patients with atrial septal defects: assessment of heart function with cardiovascular magnetic resonance during dobutamine stress.

BACKGROUND: The purpose of this study was to determine the effect of stress on left-to-right shunting in patients with atrial septal defect (ASD) and to investigate if the degree of shunting, cardiac output (CO), and right ventricular (RV) volumes are related to exercise capacity. METHODS: Twenty-six patients with a secundum ASD and 16 healthy volunteers were studied with rest/stress cardiac magnetic resonance using 20 µg/kg/min dobutamine and 0.25-0.75 mg atropine to quantify CO, pulmonary to systemic flow ratio (QP/QS), and left ventricular (LV) and RV volumes. Peak oxygen uptake (VO2peak) was determined on ergospirometry. RESULTS: In patients with ASD the QP/QS decreased from 2.0 ± 0.2 at rest to 1.5 ± 0.1 (P < 0.001) during dobutamine stress (n = 20) and shunt volume per heartbeat decreased from 70 ± 9 to 38 ± 9 mL (P < 0.001). However, absolute shunt volume per minute was unchanged (5.1 ± 0.8 vs. 4.5 ± 1.0 L/min, P = 0.32) explained by a higher increase in systemic CO during stress (90 ± 11%) compared with pulmonary CO (43 ± 7%, P < 0.001). In ASD patients, VO2peak correlated with aortic CO during stress (r = 0.77) and QP/QS at rest (r = -0.48) but not during stress (P = 0.09). VO2peak did not correlate with RV volumes in patients. CONCLUSION: Pulmonary to systemic flow ratio and shunt volume per heartbeat decrease during stress in ASD patients. This may be explained by an enhanced LV diastolic function during stress and may have implications to detect disturbances in LV compliance in ASD patients. A high systemic CO during stress is a strong predictor of exercise capacity.

Off-label use of Amplatzer Duct Occluder II additional sizes.

OBJECTIVE: To report our experience on novel, off-label use of Amplatzer Duct Occluder type II additional sizes (ADO II-AS) device (St. Jude Medical, Inc.; St. Paul, Minnesota, USA) to manage nonduct shunt lesions. METHODS AND RESULTS: Among the 114 patients submitted to ADO II-AS implantation at our institution, 12 received this device as off-label treatment of paravalvular leak (n = 5), sinus of Valsalva fissuration (n = 2), accessory atrial septal defect (n = 2), muscular ventricular septal defect (n = 1), bleeding bronchial artery aneurysm (n = 1) and reverse shunt due to abnormal origin of left subclavian artery from pulmonary artery (n = 1). Age and body weight of these patients ranged from 3 to 74 years and from 15 to 80 kg, respectively. All procedures were completed without anatomical, functional or ECG complications and without residual shunt. In one patient with mitral paravalvular leak, mild restriction of the posterior disc excursion after device deployment was recorded. CONCLUSION: In our case series, ADO II-AS was well tolerated, versatile and cost-effective in treatment of different types of nonduct shunt lesions, mainly in young children and in older patients with comorbidities.

Transcatheter Versus Surgical Closure of Atrial Septal Defects in Children: A Value Comparison.

OBJECTIVES: The purpose of this study was to determine whether a transcatheter procedure or surgical closure offers a better value proposition for atrial septal defect (ASD) closure. BACKGROUND: Secundum ASDs are common congenital heart defects with both transcatheter and surgical treatment options. Although both options have been shown to have excellent results in children, the relative value of the 2 procedures is unclear. METHODS: Using data from the Pediatric Hospital Information System for 2004 to 2012, we compared the value of transcatheter versus surgical ASD closure for children ages 1 to 17 years, with value being defined as outcomes relative to costs. Total charges for procedure-related encounters were converted to costs using hospital-specific cost-to-charge ratios, and all costs were adjusted for inflation to reflect 2012 dollars. RESULTS: There were 4,606 transcatheter procedures and 3,159 surgeries at 35 children's hospitals. Those undergoing transcatheter closure were more likely to be older (5.6 years vs. 4.5 years, p < 0.0001). There was no mortality in either group. Children with a surgical procedure had a longer length of stay (4.0 days vs. 1.5 days, p < 0.0001), were more likely to have an infection (odds ratio: 3.73, p < 0.0001) or procedural complication (odds ratio: 6.66, p < 0.0001). Costs for transcatheter procedure encounters were lower than costs for surgical encounters (mean of $19,128 vs. $25,359, p < 0.0001). CONCLUSIONS: Both transcatheter and surgical ASD closure had excellent short-term outcomes, but transcatheter procedures had lower lengths of stay, rates of infection, and complications, resulting in lower overall costs. For children who are eligible, transcatheter ASD closure provides better short-term value than surgery.

Cost comparison of transcatheter and operative closures of ostium secundum atrial septal defects.

BACKGROUND: Clinical outcomes for transcatheter and operative closures of atrial septal defects (ASDs) are similar. Economic cost for each method has not been well described. METHODS: A single-center retrospective cohort study of children and adults<30 years of age undergoing closure for single secundum ASD from January 1, 2007, to April 1, 2012, was performed to measure differences in inflation-adjusted cost of operative and transcatheter closures of ASD. A propensity score weight-adjusted multivariate regression model was used in an intention-to-treat analysis. Costs for reintervention and crossover admissions were included in primary analysis. RESULTS: A total of 244 subjects were included in the study (64% transcatheter and 36% operative), of which 2% (n = 5) were ≥18 years. Crossover rate from transcatheter to operative group was 3%. Risk of reintervention (P = .66) and 30-day mortality (P = .37) were not significantly different. In a multivariate model, adjusted cost of operative closure was 2012 US $60,992 versus 2012 US $55,841 for transcatheter closure (P < .001). Components of total cost favoring transcatheter closure were length of stay, medications, and follow-up radiologic and laboratory testing, overcoming higher costs of procedure and echocardiography. Professional costs did not differ. The rate of 30-day readmission was greater in the operative cohort, further increasing the cost advantage of transcatheter closure. Sensitivity analyses demonstrated that costs of follow-up visits influenced relative cost but that device closure remained favorable over a broad range of crossover and reintervention rates. CONCLUSION: For single secundum ASD, cost comparison analysis favors transcatheter closure over the short term. The cost of follow-up regimens influences the cost advantage of transcatheter closure.

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 procedures for treatment of ostium secundum atrial septal defects occlusion comparing conventional surgery and septal percutaneous implant.

OBJECTIVES: The study performs a cost-effectiveness analysis of procedures for atrial septal defects occlusion, comparing conventional surgery to septal percutaneous implant. METHODS: A model of analytical decision was structured with symmetric branches to estimate cost-effectiveness ratio between the procedures. The decision tree model was based on evidences gathered through meta-analysis of literature, and validated by a panel of specialists. The lower number of surgical procedures performed for atrial septal defects occlusion at each branch was considered as the effectiveness outcome. Direct medical costs and probabilities for each event were inserted in the model using data available from Brazilian public sector database system and information extracted from the literature review, using micro-costing technique. Sensitivity analysis included price variations of percutaneous implant. RESULTS: The results obtained from the decision model demonstrated that the percutaneous implant was more cost effective in cost-effectiveness analysis at a cost of US$8,936.34 with a reduction in the probability of surgery occurrence in 93% of the cases. Probability of atrial septal communication occlusion and cost of the implant are the determinant factors of cost-effectiveness ratio. CONCLUSIONS: The proposal of a decision model seeks to fill a void in the academic literature. The decision model proposed includes the outcomes that present major impact in relation to the overall costs of the procedure. The atrial septal defects occlusion using percutaneous implant reduces the physical and psychological distress to the patients in relation to the conventional surgery, which represent intangible costs in the context of economic evaluation.

Prospective randomized trial of transthoracic echocardiography versus transesophageal echocardiography for assessment and guidance of transcatheter closure of atrial septal defects in children using the Amplatzer septal occluder.

OBJECTIVES: This study sought to determine whether transthoracic echocardiography (TTE) can provide safety and efficacy equivalent to transesophageal echocardiography (TEE) for assessment and guidance of transcatheter atrial septal defect (ASD) closure in pediatric patients. METHODS: We performed a prospective randomized trial of ASD closure using the Amplatzer septal occluder (ASO) from March 2008 to April 2012. Inclusion criteria were isolated secundum ASD, age 2 to 18 years, and adequate TTE windows. Forty patients were enrolled and randomized to either TEE or TTE. In the TEE group, we used "stop flow" balloon sizing to determine device size. In the TTE group, we used the average ASD diameter times 1.2 (scaled). Patients were followed up to 1 year. RESULTS: Patient general and hemodynamic characteristics were similar in both groups. Procedural success was 100% in both groups. The average TEE stop flow diameter was similar to the scaled TTE diameter (15.35 ± 4.62 mm vs. 16.57 ± 5.47 mm; p = 0.46). Device size (16.0 ± 4.94 mm vs. 16.37 ± 5.05 mm, p = 0.82) and ratio of device to defect size (1.0 ± 0.06 vs. 0.99 ± 0.03, p = 0.52) were also similar. Total procedure (70.6 ± 22.98 min vs. 51.1 ± 17.61 min, p = 0.005), room (126.8 ± 28.41 min vs. 95.7 ± 20.53 min, p = 0.0004), and fluoroscopy (13.6 ± 6.17 min vs. 8.9 ± 8.45 min, p = 0.007) times were all significantly shorter in the TTE group. Neither group had significant complications during the procedure nor in follow-up. Rates of shunt resolution were similar between groups. CONCLUSIONS: This study suggests that in selected pediatric patients, use of TTE is as efficacious and safe as TEE for assessment and guidance of ASD occlusion using the ASO. TTE also may offer the additional safety benefit of reduced fluoroscopy exposure.

Device closure of interatrial communications: peri-interventional echocardiographic assessment.

The interventional closure of interatrial communications requires peri-interventional echocardiographic assessment and guidance to make those treatments as safe as possible. Transoesophageal echocardiography (TEE) including real-time three-dimensional (RT-3D) imaging, later complemented and in part replaced by intracardiac echocardiography (ICE), has become established as the standard approach to prepare for and to guide the interventional treatment of interatrial communications. Accurate imaging of the anatomic features of the particular communication is critical for case selection, planning, and intraprocedural guidance. Especially in the atrial septal defect (ASD) closure, which tends to be more challenging than the patent foramen ovale (PFO) closure, a certain risk of severe complications remains and may result from suboptimal device performance. Other complications may be related to discontinuous use of echocardiographic monitoring. Image fusion and RT-3D ICE are currently under clinical testing and might be suitable to facilitate spatial orientation. Nowadays, two-dimensional ICE is the method of choice for guiding percutaneous device closure, especially of ASDs and 'complex' PFOs. Uninterrupted TEE under deep sedation is an alternative. In contrast, the closure of 'simple' PFOs will often require nothing but final confirmation of the result, and therefore, short echocardiographic viewing is sufficient in many cases.

Long-term outcomes after surgical versus transcatheter closure of atrial septal defects in adults.

OBJECTIVES: The purpose of this study was to assess the comparative effectiveness and long-term safety of transcatheter versus surgical closure of secundum atrial septal defects (ASD) in adults. BACKGROUND: Transcatheter ASD closure has largely replaced surgery in most industrialized countries, but long-term data comparing the 2 techniques are limited. METHODS: We performed a retrospective population-based cohort study of all patients, ages 18 to 75 years, who had surgical or transcatheter ASD closure in Québec, Canada's second-largest province, using provincial administrative databases. Primary outcomes were long-term (5-year) reintervention and all-cause mortality. Secondary outcomes were short-term (1-year) onset of congestive heart failure, stroke, or transient ischemic attack, and markers of health service use. RESULTS: Of the 718 ASD closures performed between 1988 and 2005, 383 were surgical and 335 were transcatheter. The long-term reintervention rate was higher in patients with transcatheter ASD closure (7.9% vs. 0.3% at 5 years, p = 0.0038), but the majority of these reinterventions occurred in the first year. Long-term mortality with the transcatheter technique was not inferior to surgical ASD closure (5.3% vs. 6.3% at 5 years, p = 1.00). Secondary outcomes were similar in the 2 groups. CONCLUSIONS: Transcatheter ASD closure is associated with a higher long-term reintervention rate and long-term mortality that is not inferior to surgery. Overall, these data support the current practice of using transcatheter ASD closure in the majority of eligible patients and support the decision to intervene on ASD with significant shunts before symptoms become evident.

Prevalence of treatment, risk factors, and management of atrial septal defects in a pediatric Medicaid cohort.

Atrial septal defects (ASDs) vary greatly depending on their size, age at closure, and clinical management. This report characterizes the prevalence, complexity, and clinical management of these lesions in a statewide pediatric cohort and examines predictors for receiving closures. A 15-year Medicaid data set (1996-2010) from one state was analyzed. The selection criteria specified patients 17 years of age or younger with a diagnosis of ASD primum, secundum, or sinus venosus on one or more service visits to a pediatrician or pediatric cardiologist. During the 15-year period, ASDs represented a prevalence rate for treatment of 0.47/1000 CHDs identified, with 61 % presenting as complex lesions. Concomitant cardiac anomalies that might have a negative impact on prognosis were present including patent ductus arteriosus (26.1 %), pulmonary hypertension (3.8 %), and supraventricular tachycardia (2.4 %). Pharmacologic treatments, predominantly diuretics, were prescribed for 21 % of the cohort. Both surgical closures (6.3 %) and transcatheter closures (1.4 %) were used for ASD secundum cases, whereas surgical closures predominated for ASD primum (25.6 %) and sinus venosus (13.5 %) lesions. The postoperative follow-up period was two to three times longer for children with ASD primum or sinus venosus than for those with ASD secundum (average, ~1 year). Factors predicting the likelihood of having ASD closure were older age, having a concomitant patent ductus arteriosus (PDA) repair, treatment with ibuprofen, having two or more concomitant CHDs, and receiving diuretics or preload/afterload-reducing agents. Care of ASDs in routine practice settings involves more complications and appears to be more conservative than portrayed in previous investigations of isolated ASDs.

A tale of two balloons: assessment of hemodynamics with atrial septal defect temporary balloon occlusion.

We describe two cases in which temporary balloon occlusion (TBO) was used to determine the suitability of atrial septal defect (ASD) closure. These cases underscore the utility of TBO in select patients undergoing percutaneous closure of ASDs.

Assessment of right ventricular function by three-dimensional echocardiography and myocardial strain imaging in adult atrial septal defect before and after percutaneous closure.

Real-time three-dimensional (3D) echocardiography allows us to measure right ventricular (RV) end-diastolic volume irrespective of its shape. Tissue Doppler imaging (TDI) and speckle tracking imaging (STI) are new tools to assess myocardial function. We sought to evaluate RV function by 3D echocardiography and myocardial strain imaging in adult patients with atrial septal defect (ASD) before and 6 months after transcatheter closure in order to assess the utility of these new indexes in comparison with standard two-dimensional (2D) and Doppler parameters. Thirty-nine ASD patients and 39 healthy age- and sex-matched controls were studied using a commercially available cardiovascular ultrasound system. 2D-Doppler parameters of RV function (fractional area change, tricuspid annular plane systolic excursion, myocardial performance index) were calculated. 3D RV volumes were also obtained. RV peak-systolic velocities, peak-systolic strain, and peak systolic and diastolic strain-rate were measured in the basal, mid and apical segments of lateral and septal walls in apical 4-chamber view by TDI and STI. In open ASD, RV ejection fraction (3D-RVEF) and global and regional RV longitudinal strain were significantly higher than control group and decreased significantly after closure. By multivariate analysis 3D-RVEF, apical strain and strain rate were independent predictors of functional class. ROC analysis showed 3D-RVEF and apical strain to be more sensitive predictors of unfavorable outcome after defect closure compared to 2D-Doppler indexes. 3D echocardiography and myocardial strain imaging give useful insights in the quantitative assessment of RV function in ASD patients before and after closure.

Comparison of clinical outcomes and cost between surgical and transcatheter device closure of atrial septal defects in Singapore children.

INTRODUCTION: With advances in interventional catheterisation, transcatheter device closure of atrial septal defect (ASD) is now a feasible option to open heart surgery, especially in patients with isolated ASD. We aim to compare the outcomes, benefits and costs between device closure versus standard open-heart surgery for ASD in Singapore. MATERIALS AND METHODS: This is a comparative study between 2 cohorts with isolated secundum ASDs who underwent closure of ASD either by surgery or device, at the Department of Paediatrics, National University Hospital (NUH). The clinical outcomes, complications, length of stay and total costs incurred were compared. RESULTS: Surgical patients were at slightly greater risk of developing complications (RR=1.33; 95% CI, 0.30 to 5.95) than the device group. The median length of inpatient stay for the surgical group was significantly longer than that for the device group. Seventy percent of the patients in the device group did not need to be in ICU while 40% of patients in the surgery group stayed 2 or at least 3 days in ICU (P <0.001). The mean cost per successful procedure was $1511 (95% CI, -352 to 3375) higher for the device group patients despite a shorter length of stay in hospital. CONCLUSIONS: We concluded that transcatheter device closure is an effective and safe alternative to surgery in the treatment of suitable ASDs. Despite the high cost of the device, direct and indirect benefits for the patients and their families, who undergo device occlusion include less morbidity, better cosmesis, shorter length of stay in hospital, faster recovery and shorter time taken to resume normal activities.

Clinical value of stereoscopic three-dimensional echocardiography in assessment of atrial septal defects: feasibility and efficiency.

Stereoscopic three-dimensional echocardiography(S-3DE) is a novel displaying technology based on real-time 3-dimensional echocardiography (RT-3DE). Our study was to evaluate the feasibility and efficiency of S-3DE in the diagnosis of atrial septal defect (ASD) and its use in the guidance for transcatheter ASD occlusion. Twelve patients with secundum ASD underwent RT-3DE examination and 9 of the 12 were subjected to transcatheter closure of ASD. Stereoscopic vision was generated with a high-performance volume renderer with red-green stereoscopic glasses. S-3DE was compared with standard RT-3D display for the assessment of the shape, size, and the surrounding tissues of ASD and for the guidance of ASD occlusion. The appearance rate of coronary sinus and the mean formation time of the IVC, SVC were compared. Our results showed that S-3DE could measure the diameter of ASD accurately and there was no significant difference in the measurements between S-3DE and standard 3D display (2.89+/-0.73 cm vs 2.85+/-0.72 cm, P>0.05; r=0.96, P<0.05). The appearance of coronary sinus for S-3DE was higher as compared with the standard 3D display (93.3% vs 100%). The mean time of the IVC, SVC for S-3DE monitor was slightly shorter than that of the standard 3D display (11.0+/-3.8 s vs 10.3+/-3.6 s, P>0.05). The mean completion time of interventional procedure was shortened with S-3DE display as compared with standard 3D display (17.3+/-3.1 min vs 23.0+/-3.9 min, P<0.05). Stereoscopic three-dimensional echocardiography could improve the visualization of three-dimensional echocardiography, facilitate the identification of the adjacent structures, decrease the time required for interventional manipulation. It may be a feasible, safe, and efficient tool for guiding transcatheter septal occlusion or the surgical interventions.

Atrial and ventricular shunt closure.

Since the initial description of an atrial septal defect closure device in the mid-1970s by King and Mills, transcatheter closure of atrial septal defects using various devices has now become an established practice in many centers. These techniques have proven to be safe, cost-effective and favorably compared with surgical closure. Closure of ventricular septal defects is regarded as more complex. This article reviews several studies and includes our single-center data on 875 atrial septal defect and ventricular septal defect patients.

Major complications associated with transcatheter atrial septal occluder implantation: a review of the medical literature and the manufacturer and user facility device experience (MAUDE) database.

OBJECTIVE: To summarize major complications and outcome for patients receiving percutaneous closure of atrial septal communications. DESIGN: The Medline database and the United States Food and Drug Administration manufacturer and user facility device experience databases (MAUDE) were searched for reports related to complications with atrial septal occluding devices. The medical literature documenting complication rates for these devices were reviewed and summarized. The MAUDE database complication reports were compared with those reported in the medical literature using national implant estimates. OUTCOME: The MAUDE database correlated in the type of complications most frequently encountered with each device. However, based on estimated total implant numbers, there is a higher incidence of major complications, including death. AGA devices had a 0.3% erosion/perforation rate with a higher morbidity and mortality (29%) than previously reported. NMT devices had a lower incidence of erosion/perforation rate of 0.05%. Embolization rates for the NMT devices were also lower than published European studies, possibly reflecting the US restriction of the device for closure of patent foramen ovale. Thrombus was more frequently encountered on the NMT device. Both AGA and NMT devices have been shown to be safe and effective alternatives to cardiac surgery. The MAUDE database correlated, with a very low overall complication rate, but showed a higher estimated major complication rate than the medical literature. These data demonstrate the difficulty in quantifying rare complications in the premarketing analysis and the obligation providers have to report and evaluate complications through vigilant postmarketing surveillance.

Surgical versus percutaneous occlusion of ostium secundum atrial septal defects: results and cost-effective considerations in a low-income country.

OBJECTIVES: We compared the effectiveness and cost of percutaneous occlusion using an Amplatzer septal occluder (ASO) (AGA Medical Corp., Golden Valley, Minnesota) device compared with surgical closure of an ostium secundum atrial septal defect (ASD II) in Guatemala. BACKGROUND: The percutaneous occlusion of ASD II in first-world nations seems to offer better clinical results and lower cost compared with surgical closure. METHODS: We reviewed the clinical course of 111 patients referred to our institution for closure of isolated ASD II. Successful closure was assessed immediately after the procedures and at 12 months. Actual hospital costs were calculated for every patient who underwent either of the two procedures. RESULTS: Eighty-three patients with ASD II (75%) were selected for percutaneous occlusion with the ASO device, and the remaining 28 patients (25%) underwent surgical closure. In the device group, in 72 patients (86.7%) devices were successfully deployed. At immediate and 12-month follow-up, the complete closure rate was 87.5% (63 of 72 patients) and 97.2% (70 of 71 patients), respectively. In the surgical group, all patients had successful closure immediately after the procedure and at 12 months. Surgical closure offered a 27% cost savings in comparison with percutaneous occlusion (U.S. 3,329.50 dollars +/- 411.30 dollars and U.S. 4,521.03 dollars +/- 429.71 dollars; p < 0.001, respectively). Cost of the device (U.S. 2,930.00 dollars) proved to be the main cause for this difference. CONCLUSIONS: We confirmed the clinical advantages of percutaneous occlusion over surgical closure of ASD II. However, percutaneous occlusion costs were higher compared with surgical closure. In Guatemala, where health care resources are limited, ASD II closure with the ASO device did not prove to be cost-effective.