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Paravalvular Leak (PVL)

Valvular plug 512977760

Fills gaps fills dreams

When you had your valve replacement surgery, a new valve was inserted into your heart. This valve is usually put in place with no gaps between the edges of the valve and the surrounding natural heart tissue. Sometimes gaps can be left or develop around the replaced valve – these are known as paravalvular defects. When blood leaks through these gaps, this is known as a paravalvular leak (PVL) or paravalvular regurgitation (PVR).

Amplatzer™ Valvular Plug III
Valvular plug device patient

What are some of the symptoms of a PVL?

If a PVL is small, patients can feel little to nothing. If the PVL is moderate or severe, it can lead to the symptoms associated with heart failure, including shortness of breath, unexplained weight gain, and swelling of legs and feet. In addition, the destruction of red blood cells passing through the gaps between the artificial valve and the surrounding tissue may cause severe anemia.

PVL Facts

Pvl fact1

Paravalvular leaks

Paravalvular leaks occur in 5 to 18% of patients who undergo surgical valve implantation in the aortic or mitral locations.¹

Pvl fact2

Risk factors

Risk factors for PVL development include: annular calcification, tissue friability, prior endocarditis, or other inflammatory processes and recent initiation of corticosteroid therapy.²

Pvl fact3

Valve implantation

.PVLs can occur soon after valve replacement or several years later. ³,⁴

Pvl fact4

Emerged in the early 1990s

Transcatheter (percutaneous) PVL closure first emerged as an alternative to surgery in the early 1990s. ⁵

Amplatzer Paravalvular Plug III for surgically implanted valves

  • Most commonly used device to plug instances of
    PVL worldwide6
  • Up to 93% of PVLs effectively closed at 12 month follow-up. 7
  • Comes with Abbott service and education
Amplatzer™ Valvular Plug III
Valvular plug Clinically proven 614348016

Clinically proven in independent studies to be safe and effective

The Amplatzer Valvular Plug III, formerly known as AVP III, has
been specially designed to offer patients an effective solution to PVL, opening up a new horizon of better health and life quality. This oblong, self-expanding device is made from braided nitinol wires with shape memory characteristics, making it well suited to PVL closure.3,4,6,8

To close PVLs with different morphologies, the Amplatzer Valvular Plug III comes in a range of nine sizes and has a flexible nitinol waist, ensuring an excellent device-to-patient fit. The Amplatzer Valvular Plug III can provide an excellent solution to closure and significantly improve your quality of life, wherever you are.4,7,9,10

The Amplatzer Valvular Plug III, formerly known as AVP III, has
been specially designed to offer patients an effective solution to PVL, opening up a new horizon of better health and life quality. This oblong, self-expanding device is made from braided nitinol wires with shape memory characteristics, making it well suited to PVL closure.3,4,6,8

To close PVLs with different morphologies, the Amplatzer Valvular Plug III comes in a range of nine sizes and has a flexible nitinol waist, ensuring an excellent device-to-patient fit. The Amplatzer Valvular Plug III can provide an excellent solution to closure and significantly improve your quality of life, wherever you are.4,7,9,10

Amplatzer™ Valvular Plug III
Valvular plug tried and tested 614348016

Tried and tested

The Amplatzer Valvular Plug III leverages over 2 decades of nitinol wire design experience. It has been used extensively for more than a decade on patients all over the world.²

Consistently over time, clinical studies have shown that the Amplatzer Valvular Plug III is an effective solution in closing PVLs near mechanical surgical valves. In fact, up to 90% of patients who receive the device indicate improvements of one class in the New York Heart Association (NYHA) classification.4,7,9,10

What does this mean? Patients report easier breathing, the ability to engage in more intense physical exertion, and higher levels of physical durability.

The procedure

The Amplatzer Valvular Plug III procedure is minimally invasive. It involves making a small incision, and inserting a small tube, called a catheter, to navigate the blood vessels in order to reach the procedure site within the heart.

The doctor guides the device through the catheter to seal the PVL. Once the device is placed in the PVL, the doctor will carefully study
its position using cardiac imaging systems. Once satisfied with the position, the device is released to remain permanently in the PVL.
The catheter is removed, and the procedure is completed. The procedure itself takes place in a heart catheterization laboratory, where many minimally invasive, nonsurgical procedures are performed. Patients may be offered an anesthetic, so that no significant discomfort is felt.

Valvular plug after procedure 846278272

What happens after the procedure?

Your doctor will provide guidelines for activities and may prescribe medications that should be taken at home at their discretion.

Many doctors require follow-up appointments over the next year to ensure your recovery is going well. What to expect during and after the procedure will vary, so it is important to discuss any questions and concerns you may have with your doctor.

References
  1. Bernard S, Yucel E. Paravalvular Leaks-From Diagnosis to Management. Curr Treat Options Cardiovasc Med 2019;21:67.
  2. Ruiz CE, Hahn RT, Berrebi A, et al. Clinical trial principles and endpoint definitions for paravalvular leaks in surgical prosthesis: an expert statement. J Am Coll Cardiol. 2017;69(16):2067-2087.
  3. Garcia et al. Outcomes and predictors of success and complications for paravalvular leak closure: an analysis of the SpanisH real-wOrld paravalvular LEaks closure (HOLE) registry. EuroIntervention. 2017;12(16):1962-1968.
  4. Calvert et al. Percutaneous device closure of paravalvular leak. Circulation. 2016;134(13):934-944.
  5. Hourihan M, Perry SB, Mandell VS, et al. Transcatheter closure of valvular and perivalvular leaks. J Am Coll Cardiol 1992;20:1371
  6. Data on File at Abbott
  7. Smolka G, Pysz P, Jasiński M, et al. Multiplug paravalvular leak closure using Amplatzer Vascular Plugs III: A prospective registry. Catheter Cardiovasc Interv. 2016;87(3):478-487.
  8. Sanchez-Recalde et al. Immediate and Mid-term Clinical Course After Percutaneous Closure of Paravalvular Leakage. Rev Esp Cardiol. 2014;67(8):615–62
  9. Yildirim A, Goktekin O, Gorgulu S, et al. A new specific device in transcatheter prosthetic paravalvular leak closure: a prospective two-center trial. Catheter Cardiovasc Interv. 2016;88(4):618-624.
  10. Angulo-Llanos R, Sarnago-Cebada F, Rivera AR, et al. Two-Year Follow Up After Surgical Versus Percutaneous Paravalvular Leak Closure: A Non-Randomized Analysis. Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2016;88(4):626-634.
MAT-2013068 v1.0 | Item approved for OUS use only.

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