Name of the Procedure:

Septal Defect Implant System, Intracardiac (C1817)

Common name(s): Septal Defect Repair, ASD/VSD Closure Device Insertion

Summary

A minimally invasive procedure to place a specialized implant in the heart, used to repair a hole (septal defect) between the heart's chambers. This helps restore normal blood flow and improve heart function.

Purpose

The procedure addresses septal defects such as atrial septal defects (ASD) or ventricular septal defects (VSD), which are abnormal openings in the heart's septum. The goal is to close the opening, prevent improper blood flow, and reduce the risk of complications such as heart failure or stroke.

Indications

• Presence of a confirmed atrial or ventricular septal defect.
• Symptoms like shortness of breath, fatigue, or recurrent respiratory infections.
• Evidence of heart enlargement or other structural changes detected through imaging.
• Patients who are at higher risk for complications from open-heart surgery.

Preparation

• Patients are usually required to fast for at least 8 hours before the procedure.
• Certain medications may need to be adjusted or stopped.
• Pre-procedure tests may include echocardiograms, electrocardiograms (ECG), chest X-rays, and blood tests.

Procedure Description

1. The patient is given local anesthetic and sedation, or in some cases, general anesthesia.
2. A catheter is inserted into a blood vessel in the groin and guided to the heart using imaging technology.
3. The septal defect implant system is delivered through the catheter to the site of the defect.
4. The device is deployed to cover the hole, and its position is confirmed via imaging.
5. Catheter is removed and the insertion site is closed.

Tools: Catheter, septal defect implant device, imaging technology (e.g., fluoroscopy, echocardiography).

Duration

The procedure typically takes between 1 to 2 hours.

Setting

The procedure is typically performed in a cath lab within a hospital or specialized cardiac center.

Personnel

• Interventional cardiologist
• Cardiac surgeon (if necessary)
• Anesthesiologist or sedation nurse
• Cardiac technician
• Nursing staff

Risks and Complications

• Infection at the catheter insertion site
• Bleeding or bruising
• Device dislodgement
• Arrhythmias (irregular heartbeats)
• Allergic reactions to contrast dye or medication

Benefits

• Reduction or elimination of symptoms such as shortness of breath and fatigue.
• Decreased risk of future cardiac complications.
• Minimally invasive approach with quicker recovery time compared to open-heart surgery.

Recovery

• Patients are usually observed in the hospital for 24-48 hours.
• Instructions include avoiding strenuous activities for a few days, keeping the insertion site clean, and taking prescribed medications.
• Follow-up appointments are essential to monitor the success of the procedure and overall heart health.

Alternatives

• Medical management (medications to manage symptoms but not correct the defect)
• Open-heart surgery to repair the defect directly
• Pros of the implant procedure: Less invasive, shorter recovery
• Cons: Not suitable for defects that are too large, carries some risk of complications

Patient Experience

During the procedure, patients may feel slight pressure or discomfort at the insertion site. Afterward, mild pain or bruising in the groin area is common. Pain management may include over-the-counter pain relievers. Most patients can return to normal activities within a week but should follow their doctor's guidelines for a safe recovery.