The Burden of Atrial Septal Defects (ASD)4,5


 

Symptoms of ASD

Patients who have large atrial shunts can experience symptoms related to excess pulmonary blood flow and right-sided heart failure.

Symptoms in infants to young adults (~20 years of age):


Most children with isolated ASDs are asymptomatic. If patients are untreated however, symptoms can occur in adulthood.6


 

Symptoms in older adults:


 

50% of adults with untreated secundum defect have reduced exercise capacity of 50%-60%6


 


 

The Risk of a Late Diagnosis and Undertreatment

Because many ASD patients experience a gradual onset of symptoms—and may exhibit only subtle physical findings—late diagnosis can occur, putting them at a higher risk for arrhythmias, pulmonary arterial hypertension, left ventricular systolic dysfunction, and paradoxical embolism.

 

Untreated large secundum ASD annual mortality rates for patients in their:6

 

40s is 4.5%

60s is 7.5%


 

Are there any treatment options for ASD patients?7

There are a number of treatment options for ASD, and there is no single option that is suitable for every patient. However, there are a few standard approaches that should be considered. The first option is medical therapy that may be used to manage the symptoms associated with ASD. Other treatment options include open-heart surgery and catheter-based procedures to close the defect. A catheter-based procedure is a minimally invasive treatment option available to some patients. 

The Amplatzer™ Septal Occluder Solution

Abbott’s Amplatzer™ Septal Occluder is the proven standard of care8,9 — with more than 20 years of global clinical experience in ASD closure.10

Patients diagnosed with an ASD, who are indicated for closure with an Amplatzer™ Septal Occluder, exhibit both:11

  • Echocardiographic evidence of ostium secundum ASD
  • Clinical evidence of right ventricular (RV) volume overload (i.e., ratio of pulmonary to systemic flow > 1.5 or RV enlargement)

References

References

1.  PubMed (2018, Mar.) Retrieved from www.pubmed.gov.

2. Thomson JD, Qureshi SA. Device closure of secundum atrial septal defect's and the risk of cardiac erosion. Echo Res Pract. 2015;2(4):R73-78.

3. Nassif M, et al. Historical developments of atrial septal defect closure devices: what we learn from the past. Expert Review of Medical Devices. 2016;13(6):555-568.

4.  Australian Institute of Health and Welfare 2019. Congenital heart disease in Australia. Cat. no. CDK 14. Canberra: AIHW.

5.  Nyboe C, et al. Long-term mortality in patients with atrial septal defect: a nationwide cohort-study. Eur Heart J. 2018;39:993-998.

6.  Geva T, et al. Atrial septal defects. Lancet. 2014;383:1921-1932.

7. Stout KK, et al. 2018 AHA/ACC guideline for the management of adults with congenital heart disease: a report of the American College of Cardiology/ American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2018;000:e000–e000.

8.  Kashour TS, et al. Successful percutaneous closure of a secundum atrial septal defect through femoral approach in a patient with interrupted inferior vena cava. Congenit Heart Dis. 2010;5:620–623.

9.  Tadros VX, Asgar AW. Transcatheter closure of atrial septal defects: an update on ASD occlusion devices. Card Interv Today. 2016; March-April.

10.  Data on file at Abbott.

11. AmplatzerTM Septal Occluder Instructions for Use.

Why Choose the Amplatzer™ Septal Occluders?

The Amplatzer™ line not only pioneered structural heart defect occluder devices, but it also remains the global leader in innovation and treatment and is the most studied transcatheter ASD closure device available.1-5


 

Following ASD occlusion, patients may benefit from:5

Symptom
Improvement

Patients typically report symptom improvement following ASD closure.

Benefits for Young Adults
and Children

Increased growth rate in young children and improvements in LV filling in children and young adults.

Normalisation
of the RV

Greater likelihood of normalisation of RV size in younger patients who had less chamber enlargement before repair.

Discover the Amplatzer™ Septal Occluders

Abbott offers two devices for percutaneous, transcatheter ASD closure:

The Amplatzer™ Septal Occluder for patients with an ASD in the secundum position or patients who have undergone a fenestrated Fontan procedure and who now require closure of the fenestration.6


 

The Amplatzer™ Cribriform Occluder for the closure of multi-fenestrated (cribriform) ASDs.7

 


 


*This testimonial relates an account of an individual’s response to the treatment. This patient’s account is genuine, typical and documented. However, it does not provide any indication, guide, warranty or guarantee as to the response other persons may have to the treatment. Responses to the treatment discussed can and do vary and are specific to the individual patient.


 

Abbreviations and References

Abbreviations: LV, Left Ventricle; RV, Right Ventricle.

References:

1.  PubMed (2018, Mar.) Retrieved from www.pubmed.gov.

2. Thomson JD, Qureshi SA. Device closure of secundum atrial septal defect's and the risk of cardiac erosion. Echo Res Pract. 2015;2(4):R73-78.

3. Nassif M, et al. Historical developments of atrial septal defect closure devices: what we learn from the past. Expert Review of Medical Devices. 2016;13(6):555-568.

4. Data on file at Abbott.

5.  Baumgartner H, et al. 2020 ESC Guidelines for the management of adult congenital heart disease. Eur Heart J. 2021;42(6):563-645.

6.  AmplatzerTM Septal Occluder Instructions for Use.

7.  AmplatzerTM Multi-Fenestrated Septal Occluder - Cribriform Instructions for Use.

Clinical Evidence: Amplatzer Septal Occluders

U.S. Pivotal Trial4

This study was conducted to determine the safety and efficacy of transcatheter ASD closure involving 442 device-closure patients and 911.5 total patient-years of device experience.

Trial Results Showed:

Amplatzer™ Septal Occluder Post-Approval Study5

This study evaluated the long-term safety and efficacy of the Amplatzer Septal Occluder from 1,000 patients reported in July 2011.

Study Results Showed:

97.9%

Procedural success rate

98.5%

One-month closure rate

97.9%

Two-year closure rate

0.3%

Cardiac erosion rate

MAGIC Atrial Septal Defect Study6

This study evaluated the initial safety and results of unrestricted multi-institution routine use of the Amplatzer™ Septal Occluder in 478 patients.

Study Results Showed:

96%

Procedual success rate

99%

1-Day closure rate

1.1% & 4.8%

Major and minor complication rates respectively

References

References:

1.  PubMed (2018, Mar.) Retrieved from www.pubmed.gov.

2. Thomson JD, Qureshi SA. Device closure of secundum atrial septal defect's and the risk of cardiac erosion. Echo Res Pract. 2015;2(4):R73-78.

3. Nassif M, et al. Historical developments of atrial septal defect closure devices: what we learn from the past. Expert Review of Medical Devices. 2016;13(6):555-568.

4.   Du ZD, et al. Comparison between transcatheter and surgical closure of secundum atrial septal defect in children and adults: results of a multicenter nonrandomized trial. J Am Coll Cardiol. 2002;39:1836-1844.

5.  Turner DR, et al. Closure of secundum atrial septal defects with the Amplatzer Septal Occluder: a prospective, multicenter, post-approval study. Circ Cardiovasc Interv. 2017;10:e004212.

6.  Everett AD, et al. Community use of the Amplatzer atrial septal defect occluder: results of the multicenter MAGIC atrial septal defect study. Pediatr Cardiol. 2009;30:240-247.


 

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