Title: The Impact of Transcatheter Atrial Septal Defect Closure in the Older Population: A Prospective Study
Topic: Congenital Heart Disease
Date Posted: 4/28/2010
Author(s): Khan AA, Tan JL, Li W, et al.
Citation: JACC Cardiovasc Interv 2010;3:276-281.
Clinical Trial: No
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JACC Cardiovasc Interv Article: The Impact of Transcatheter Atrial Septal Defect Closure in the Older Population: A Prospective Study
Study Question: What is the safety and efficacy of transcatheter atrial septal defect (ASD) closure in an older population?
Methods: In this single-center, prospective clinical trial, consecutive patients ages >40 years with hemodynamically significant ASD (defined by right heart dilation and Qp:Qs ≥1.5 by echocardiogram) were enrolled. Study protocol included laboratory testing (atrial and brain natriuretic peptides), electrocardiogram, chest X-ray, transthoracic echocardiogram (ECHO), 6-minute walk test (6MWT), quality of life (QOL; assessed with short form 36, version 2), and assessment of New York Heart Association (NYHA) functional class, with all tests performed immediately prior to ASD closure and at 6 weeks and 1 year post-closure. Transcatheter ASD closure was performed with the Amplatzer septal occluder (AGA Medical) using balloon sizing or intraprocedural echocardiography.
Results: Twenty-three patients (57% female, mean 69 years) were enrolled and all underwent successful device implantation. Significant comorbidities included atrial fibrillation (21%), hypertension (30%), hypercholesterolemia (26%), ischemic heart disease (13%), and chronic renal failure (4%). At the time of device implantation, mean pulmonary artery (PA) pressure was 22 mm Hg, Qp:Qs was 2.2, and ASD size was 18 mm. Mean implanted device size was 24 mm (range 10-36 mm), with two patients requiring implantation of two devices for separate defects. New-onset atrial fibrillation in one patient was the only significant periprocedural complication reported. NYHA functional class improved in the majority of patients from predominately class II (70%) preclosure to predominately class I (78%) at 1-year follow-up (p < 0.0001). 6MWT distance improved from 400 m at baseline to 451 and 493 m at 6-week and 1-year follow-up, respectively (p = 0.001). QOL physical and mental health scores increased significantly at 1 year (p ≤ 0.007). One-year ECHO follow-up demonstrated significant reduction in right ventricular diastolic dimension and right atrial volume, and increase in left ventricular diastolic and systolic dimensions and ejection fraction (p ≤ 0.004).
Conclusions: Percutaneous ASD closure is feasible in an older population and results in functional and anatomic improvements at 1 year.
Perspective: This prospective study, although nonrandomized, demonstrates that transcatheter ASD device closure can be undertaken in an older population with minimal procedural adverse effects. Efficacy of ASD device closure (i.e., presence of residual atrial level shunt) is not reported. The study cohort is small (n = 23), generally healthy (only 13% had ischemic heart disease), and uncommonly encountered clinically (no subjects had significant pulmonary hypertension despite a mean ASD size of 18 mm, Qp:Qs of >2:1, and age of nearly 70 years), all factors that limit the generalizability of this study. Timothy B. Cotts, M.D., F.A.C.C., Bryan Goldstein, M.D.
Title: Primary Transcatheter Patent Foramen Ovale Closure Is Effective in Improving Migraine in Patients With High-Risk Anatomic and Functional Characteristics for Paradoxical Embolism
Topic: Congenital Heart Disease
Date Posted: 4/28/2010
Author(s): Rigatelli G, Dell’Avvocata F, Ronco F, et al.
Citation: JACC Cardiovasc Interv 2010;3:282-287.
Clinical Trial: yes
Related Resources
JACC Cardiovasc Interv Article: Primary Transcatheter Patent Foramen Ovale Closure Is Effective in Improving Migraine in Patients With High-Risk Anatomic and Functional Characteristics for Paradoxical Embolism
Study Question: What is the effectiveness of transcatheter patent foramen ovale (PFO) closure in improving migraine in a group of patients with high-risk anatomic and functional characteristics for paradoxical embolism?
Methods: In this single-center, nonrandomized, prospective trial, patients with medication-refractory migraine and PFO referred for consideration of transcatheter PFO closure were enrolled. The Migraine Disability Assessment Score (MIDAS) was administered to all patients for evaluation of migraine severity. Device closure of PFO was performed in patients meeting high-risk inclusion criteria, including: curtain shunt pattern of right-to-left (R-L) shunt on transcranial Doppler (TC-D) and transesophogeal echocardiography (TEE), refractory and disabling migraine (MIDAS class 3-4), PFO, R-L shunt during normal respiration, atrial septal aneurysm, coagulation abnormalities, and presence of eustachian valve. Transcatheter PFO closure was performed using devices from AGA Medical Corporation and St. Jude Medical Incorporated, based on specific intracardiac echocardiographic findings. Follow-up included TEE, TC-D, MIDAS, and clinical interviews.
Results: Eighty-six patients (79% female, mean 35 ± 6.7 years) were enrolled and 40 met criteria for transcatheter PFO closure. Patients ineligible for PFO closure received standard of care medical management. Transcatheter PFO closure was successful and performed without periprocedural complications in all 40 subjects. The Amplatzer PFO Occluder was used in eight patients, Amplatzer Cribriform Occluder in 14 patients, and Premere occlusion system in 18 patients. At a mean follow-up of 29.2 ± 14.8 months, mean MIDAS score had fallen from 35.8 ± 4.7 to 8.3 ± 7.8 (p < 0.03) in the PFO closure group, and from 22.6 ± 7.1 to 19.1 ± 8.2 (p = 0.06) in the medical management group. PFO closure without residual shunt was achieved in 95% of subjects. Of 32 subjects who reported migraine with aura at baseline, all subjects reported abolishment of aura at follow-up. New-onset atrial fibrillation developed in 5% of PFO closure patients during follow-up.
Conclusions: In a highly selected population of patients with medically-refractory migraines and PFO with certain proposed high-risk anatomic and functional features, transcatheter PFO closure resulted in a marked reduction in migraine severity and abolition of aura.
Perspective: The MIST (Migraine Intervention with Starflex Technology) study, a large, randomized, sham-controlled study, failed to demonstrate significant symptomatic improvement in patients with migraine undergoing PFO closure. The question remains as to whether a subset of selected patients with migraine might benefit from PFO closure. This nonrandomized, possibly nonconsecutive, series reported by Rigatelli et al. is unique in its selection of patients with high-risk characteristics (for R-L shunt and microembolism) for PFO closure. This kind of highly selected group (whether using the described characteristics or others) may represent a subset of migraineurs more likely to respond to transcatheter therapy. However, the absence of a sham-control group and randomization of consecutive subjects severely limit the generalization of these data. Timothy B. Cotts, M.D., F.A.C.C., Bryan Goldstein, M.D.