For Patients
What is the V-Wave™ Ventura Interatrial Shunt?
The V-Wave Ventura Interatrial Shunt is a small device that stays in the heart permanently. It is made of medical grade materials, and has no battery and no moving parts.
How It Works
The heart has two upper chambers called the atria (a “left atrium” and a “right atrium”). The shunt creates a pathway (opening) that allows a small amount of blood flow from the left atrium to the right atrium. It is designed to lower pressure on the left side of the heart and keep patients out of the hospital.1
Clinical Study Findings
A recent clinical study found that HFrEF patients* who received a shunt compared to those who did not:
Experienced 48% fewer Heart Failure Hospitalizations over 2 years
Experienced 45% fewer Heart Failure events over 2 years
Who Is It For?
You may be eligible if the following apply to you:
- Your heart failure has been described as NYHA (New York Heart Association) class III, meaning a noticeable limitation in activities.
- Your heart's pumping function is reduced;described as pumping strength (ejection fraction) of 40% or less.
- You are taking your medication, but have still experienced a hospitalization due to your heart failure OR - You are taking your medication s and continue to experience symptoms of heart failure.
- You are not planning another procedure for your heart in the next 6 months.
Please talk to your physician for a full assessment to see if you qualify.
What Can You Expect During a Procedure?
The shunt is put in the heart through a minimally invasive procedure.1
The procedure is done in a hospital catheterization lab (a special procedure room with X-ray imaging).
The procedure usually takes about 1 to 2 hours.
The care team decides whether light sedation or general anesthesia is used.
A small puncture is made in the groin to reach a vein, then a thin tube (catheter) is guided to the heart.
Pressures in the heart are measured to confirm whether the shunt can be placed.
A small opening is made in the wall between the two upper chambers of the heart.
The V-Wave Ventura Interatrial Shunt is positioned between the left and right atria.
Imaging equipment will be used to help guide the placement of the device in your heart.
The Shunt Will Start Working Right Away
Once the shunt is in place it will allow a small amount of blood to move from the left atrium to the right atrium. You may start to notice a reduction in heart failure symptoms that lead to hospitalizations.
You may stay in the hospital overnight for observation and be discharged the following morning. After you are discharged, you will follow up with your regular cardiologist or family doctor. You will be given instructions for returning to normal activities.
Post-Procedure Medication and Preventive Care
If you are not currently taking a blood thinner for another medical reason, your doctor will prescribe an antiplatelet medication such as Clopidogrel for approximately 6 months and low-dose aspirin daily for the rest of your life.
Your doctor will tell you how long you should be taking antiplatelet medications that help prevent blood clots and narrowing of the shunt. It is very important to take these medications exactly as instructed by your doctor.
Regular medical follow-up is advised to evaluate the proper functioning of the Shunt. Your doctor may schedule a heart ultrasound as follow-up to assess for blood flow through the shunt.
Notify your doctor if you are scheduled to see a dentist. Your doctor may want to prescribe an antibiotic prior to any major procedures or dental work to decrease the risk of infective endocarditis (heart infection) for up to six months after implantation.
Continue to take your medications as prescribed to manage your heart failure. This device is not a replacement for medical therapy.
Potential Complications and Adverse Events
The following anticipated events have been identified as possible complications of implantation of the V-Wave Ventura Interatrial Shunt. The potential complications include, but are not limited to, the following:
* Abnormal laboratory results
* Acute decompensated heart failure
* Allergy, anaphylactic reaction, drug reaction to contrast medium, anesthesia, or device components
* Arrhythmia
* Atrial septal defect (iatrogenic)
* Bleeding
* Cardiac arrest
* Cardiac or great vessel perforation
* Cardiac tamponade
* Coagulopathy
* Damage to adjacent cardiac structures
* Death
* Deep venous thrombosis (DVT)
* Device migration, embolization, or erosion
* Gastrointestinal disturbance (peritonitis, infarction, ileus, nausea, vomiting, diarrhea)
* Device thrombosis
* Dislodgement of previously implanted devices
* Effusion (e.g., pericardial, pleural, ascites)
* Emboli (air, thrombus, device)
* Emergency cardiac or vascular surgery
* Esophageal irritation, bleeding, perforation, or stricture
* Failure to deliver interatrial shunt to its intended site
* Failure to retrieve delivery system components
* Fever or hyperthermia
* Hematuria
* Hemorrhage requiring transfusion
* Hypertension or hypotension
* Hypoxemia
* Infection (including septicemia and endocarditis)
* Interference with other implanted devices
* Loss of limb
* Myocardial infarction
* Nerve damage
* Pain
* Permanent disability
* Pneumothorax
* Pulmonary hypertension
* Pulmonary thromboembolism
* Reintervention/closure due to excessive shunting
* Removal of shunt due to infection
* Renal insufficiency
* Respiratory failure, atelectasis, pneumonia
* Seizure
* Shock (cardiogenic or anaphylactic)
* Skin irritation or inflammation
* Stridor
* Stroke or transient ischemic attack (TIA)
* Syncope
* Thrombosis
* Urinary retention
* Urinary tract infection
* Vascular trauma (dissection, occlusion, hematoma, arteriovenous fistula, pseudoaneurysm, perforation, spasm)
* Worsening RV Failure and Pulmonary Hypertension
For complete information on the benefits and risks of the procedure, please speak with your doctor and refer to the Instructions for Use.
*NYHA Class III HFrEF patients (LVEF<40%) who remain symptomatic despite GDMT.
References
Stone G, Lindenfeld j, Rodes-Cabau J, et al. Interatrial Shunt Treatment for Heart Failure:The Randomized RELIEVE-HF Trial. Circulation 2024; 150:00–00. DOI: 10.1161/CIRCULATIONAHA.124.070870
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