10/10/2016
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`Transcatheter Repair of Paravalvular Leak | Diagnostic and Interventional Cardiology
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`FEATURE | HEART VALVE TECHNOLOGY (/CHANNEL/HEART-VALVE-TECHNOLOGY) | FEBRUARY 08, 2016|
`DAVE FORNELL
`Transcatheter Repair of Paravalvular Leak
`O(cid:212)-label use of vascular plugs can successfully reduce the severity of paravalvular aortic and
`mitral valve leak
`
`Transcatheter repair of a surgical mitral replacement paravalvular leak with an Amplatzer Vascular Plug
`II.
`
`O(cid:212)-label use of the St. Jude Amplatzer vascular plug devices o(cid:212)ers a new solution for the minimally
`invasive repair of paravalvular leaks. Paravalvular leaks around surgical valve implants can result in poor
`outcomes, and the heart needing to work harder to pump can lead to heart failure. The small holes that
`cause paravalvular leak also form a Venturi e(cid:212)ect, causing fast-moving jets that can lead to red blood
`cell destruction (hemolysis), causing anemia and fatigue.
`
`Paravalvular leaks are a common issue with mechanical valve implantation. In 15-50 percent of cases,
`small paravalvular leaks are detected, but these are typically of minimal clinical signi(cid:213)cance.[1]
` However, in 1-5 percent of these cases, the leaks are associated with hemolysis, arrhythmias or
`congestive heart failure.[1-7]
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`10/10/2016
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`Transcatheter Repair of Paravalvular Leak | Diagnostic and Interventional Cardiology
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`Transcatheter repair of these leaks represents a new treatment option for these patients, who are often
`too frail for repeat surgery. Sessions on this technique presented at the Cardiovascular Research
`Foundation’s Transcatheter Valve Technologies (TVT) and Transcatheter Cardiovascular Therapeutics
`(TCT) conferences the past couple years have been packed. One of the key experts in this (cid:213)eld is
`Charanjit Rihal, M.D., chief of cardiology and professor of medicine, Mayo Clinic, Rochester, Minn.
`
`“The vast majority of our practice is with surgical valves, with 80 percent of these being mitral valves.
`And it seems to be a more common problem with mechanical valves than with tissue valves,” Rihal said.
`
`He said the next most common repairs they perform are for surgical aortic valve replacements, followed
`by transcatheter aortic valve replacements (TAVR). Earlier versions of the Edwards Sapien and
`Medtronic CoreValve TAVR valves had paravalvular regurgitation, but the newest versions approved in
`2015, especially the Sapien 3, have helped reduce this issue.
`
`TAVR trials have shown an incidence of 10-20 percent of patients with paravalvular leak, and the data
`show this can lead to less than optimal outcomes, Rihal said. “In the best of all possible worlds there
`would be no paravalvular regurgitation, and we are optimistic that the next generation of TAVR valves
`will help eliminate this,” he said.
`
`To seal these leaks, Amplatzer Vascular Plug II devices are used to (cid:213)ll the holes that have formed on the
`sides of the valve implant.
`
`He said the devices do endothelize, but may not completely stop the leak, However, he said that is
`alright. “To treat the heart failure, we don’t have to eliminate the leak, we just have to reduce it. If we can
`reduce the regurgitation from severe to mild, the patient will feel much better. It is di(cid:212)erent for
`hemolysis, where it is very important to eliminate the leak, because even small, high-velocity jets can
`result in hemolysis,” he explained.
`
`Watch a video interview with Charanjit Rihal on transcatheter paravalvular leak repair from TVT 2015.
`(http://www.dicardiology.com/videos/transcatheter-paravalvular-leak-repair-procedures-tvt-
`2015/4302221486001)
`
`
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`Friable Cardiac Tissue is Cause of Most Leaks
`
`The high rate of leak with mitral valves is usually due to the patient’s valve annulus tissue being
`calci(cid:213)ed. Rihal said surgeons have issues suturing in calci(cid:213)ed tissue and the sutures may pull out with
`normal heart movement.
`
`Other challenges Rihal’s team has found are with valve implants in post-endocarditis patients or the
`very elderly where the tissue tends to be very friable. This is particularly true if they have some form of
`chronic in(cid:214)ation problem, such as lupus or rheumatoid arthritis. He explained the tissue friability issue
`worsens if the patient is put on steroids. The condition causes sutures to just tear through the weakened
`cardiac tissue.
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`10/10/2016
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`Transcatheter Repair of Paravalvular Leak | Diagnostic and Interventional Cardiology
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`“You have to understand this is underdiagnosed,” Rihal said. “This is because it is often very di(cid:215)cult to
`visualize these leaks because on transthoracic echo [TTE] there is acoustic shadowing from the valve,
`the sewing ring and the calcium. So unless you are doing systematic transesophageal echo [TEE]
`surveys, which we usually don’t do, it is di(cid:215)cult to really know what the true incidence of this is.”
`Overall, he said the incidence is likely 5-10 percent of surgical valve replacements.
`
`Imaging for the Procedure
`Acoustic shadowing from TTE may totally obscure the view of some leaks, said Rebecca Hahn, M.D.,
`director of interventional echocardiography, Columbia University Medical Center / New York-
`Presbyterian Hospital. Hahn spoke on the imaging needs for interventional paravalvular leak repairs at
`TVT 2015. For this reason, she said these procedures take place mainly under real-time 3-D/4-D TEE.
`Hahn said echo can con(cid:213)rm the delivery catheter is in the leak defect and not through the valve. It also
`can con(cid:213)rm the closure device is not touching the valve lea(cid:214)ets. Using color Doppler, echo can show
`the paravalvular jets to aid device navigation and help decide if additional devices are needed. It is also
`used for post-procedural assessments.
`
`“The beauty of 3-D echo is that it allows us to also characterize the jets,” Hahn explained. “This allows
`us to pre-procedurally plan the devices we will choose, the sizing of the devices and the approach for
`deployment [transseptal or transapical].”
`
`She said procedural navigation systems that merge live TEE with live angiography are not necessary, but
`are a great aid for novice operators in this type of procedure. For those operators, Hahn said these
`systems can signi(cid:213)cantly shorten procedural time.
`
`The Procedure
`“With the mitral valve, we have adopted an antegrade transseptal approach,” Rihal said. “You put a
`catheter into the left atrium and that is de(cid:214)ectable, so you can bend and steer it. Using that catheter,
`you pass a wire through the defect and then over the wire you send in a delivery guide catheter — it can
`be a coronary guiding catheter for example. Then, through that, there are a variety of plugs we can use.”
`
`He said Mayo prefers to use thinner braid nitinol devices, such as the Amplatzer family of plugs, with
`the Amplatzer Vascular Plug II device being the workhorse for this kind of work. He said it is often
`necessary to use more than one plug to seal the holes. A tug test is usually performed to ensure the
`device is stable before its (cid:213)nal release.
`
`“None of these devices have been designed for this type of work, but there are no purpose-built devices
`and that has been the issue,” Rihal explained. “So we are sort of jury-rigging these devices to treat this
`very important problem. For that reason, we often have to use two or three of these devices to
`completely seal it o(cid:212) since we don’t have a single purpose-built device to do the job. I think they are
`pretty e(cid:212)ective, and about 99 percent of the time we can get adequate closure. We usually cannot
`completely eliminate the leak, but we can help improve the patient’s symptoms and relieve their
`hemolysis as well.”
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`Transcatheter Repair of Paravalvular Leak | Diagnostic and Interventional Cardiology
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`While the Amplatzer vascular plug was originally designed and cleared for vascular embolization, Rihal
`explained the design makes it ideal for closing paravalvular leaks. It has two self-expanding nitinol wire
`disks that open on either side of the valve, similar to the Amplatzer septal defect occluders, but are
`made of a (cid:213)ner wire. The plugs also have a raised, self-expanding center section that Rihal said helps (cid:213)ll
`the “nooks and crannies” along the side of the valve. The center section of the device has six layers of
`nitinol mesh, which helps occlude the hole. The Amplatzer II comes in sizes of 3-22 mm.
`
`He said the Amplatzer III also seems to be a good device for this application, but it is not available in
`the United States. That device is approved in Europe and cardiologists there are using it to close
`paravalvular mitral leaks. The Amplatzer III is more of an oval/rectangular shape instead of a circle,
`which Rihal said might make it a good candidate for paravalvular leak closure.
`
`“The Amplatzer IV is an interesting device because it seems to be ideally suited for post-TAVR
`paravalvular leaks,” Rihal said. “It will (cid:213)t into anything that will accommodate an 0.038 wire, including a
`diagnostic catheter, making the device more versatile.”
`
`He said the Amplatzer I is not useful for leak closures.
`
`For very large defects, larger sheaths are best to use because you can get multiple devices through them,
`said Samir Kapadia, M.D., professor of medicine, director, cardiac catheterization laboratories, Cleveland
`Clinic, who also presented at TVT 2015. He showed one case where he used a 20 French Cook sheath to
`facilitate deployment of what was originally planned to be three Amplatzer II devices at once. The
`defect was so large that it required the use of eight devices. He said it is easier to use a large sheath and
`use vascular closure devices to seal the entry site than to use a smaller sheath when multiple devices will
`be needed.
`
`Creating Dedicated Devices
`The tearing of sutures usually causes irregular shaped holes. Rihal suggested if a new dedicated device
`were created, he would build a universal device that could be used to treat all patients. He explained it
`would need something like a liquid polymer injected into its core to seal the interior of the device once
`implanted to completely (cid:213)ll the hole and prevent any residual regurgitation.
`
`In October 2014, the Occlutech Paravalvular Leak Closure Device (PLD) was the (cid:213)rst dedicated
`paravalvular leak occluder device to gain European CE mark market clearance. The device looks like a
`square version of the Amplatzer, using a similar (cid:214)exible, self-expanding nitinol wire mesh. The implant
`is available in di(cid:212)erent con(cid:213)gurations, multiple sizes and can accommodate a broad range of
`paravalvular leak anatomies. The device can be delivered transapically or transfemorally. Placement is
`aided by two gold markers that can be visualized on angiography.
`
`References:
`1. Bhindi R, Bull S, Schrale RG, Wilson N, Ormerod OJ. “Surgery insight: percutaneous treatment of
`prosthetic paravalvular leaks.” Nat Clin Pract Cardiovasc Med 2008;5(3):140–7. [PubMed]
`2. Pate GE, Al Zubaidi A, Chandavimol M, Thompson CR, Munt BI, Webb JG. “Percutaneous closure of
`prosthetic paravalvular leaks: case series and review.” Catheter Cardiovasc Interv 2006;68(4):528–33.
`
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`Transcatheter Repair of Paravalvular Leak | Diagnostic and Interventional Cardiology
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`[PubMed]
`3. Webb JG, Pate GE, Munt BI. “Percutaneous closure of an aortic prosthetic paravalvular leak with an
`Amplatzer duct occluder.” Catheter Cardiovasc Interv 2005;65(1):69–72. [PubMed]
`4. Sorajja P, Cabalka AK, Hagler DJ, Reeder GS, Chandrasekaran K, Cetta F, Rihal CS. “Successful
`percutaneous repair of perivalvular prosthetic regurgitation.” Catheter Cardiovasc Interv
`2007;70(6):815–23. [PubMed]
`5. Dussaillant GR, Romero L, Ramirez A, Sepulveda L. “Successful percutaneous closure of
`paraprosthetic aorto-right ventricular leak using the Amplatzer duct occluder.” Catheter Cardiovasc
`Interv 2006;67(6):976–80. [PubMed]
`6. Echevarria JR, Bernal JM, Rabasa JM, Morales D, Revilla Y, Revuelta JM. “Reoperation for
`bioprosthetic valve dysfunction. A decade of clinical experience.” Eur J Cardiothorac Surg 1991;
`5(10):523–7. [PubMed]
`7. Zoghbi WA, Chambers JB, Dumesnil JG, Foster E, Gottdiener JS, Grayburn PA, et al.
`“Recommendations for evaluation of prosthetic valves with echocardiography and Doppler ultrasound:
`a report from the American Society of Echocardiography's Guidelines and Standards Committee and
`the Task Force on Prosthetic Valves.” J Am Soc Echocardiogr 2009;22(9):975–1014. [PubMed]
`8. Kurt S. Ho(cid:212)mayer, Christian Zellner, Damon M. Kwan, et al. “Closure of a Para-valvular Aortic Leak
`with the Use of Amplatzer Devices and Real-Time 2− and 3-Dimensional Transesophageal
`Echocardiography.” Tex Heart Inst J. 2011; 38(1): 81–84.
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`Transcatheter Repair of Paravalvular Leak | Diagnostic and Interventional Cardiology
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`Paravalvular leak repair using eight Amplatzer II devices around a mechanical valve replacement. The
`large Amplatzer device to the right is a an earlier repair for a septal defect.
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