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28—PULMONARY VALVE INTERVENTIONS 337

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INDICATIONS FOR INTERVENTION

Typical guidelines for consideration of TPVR are similar to those for surgical pulmonary valve replacement. Moderate-to-severe RVOT obstruction (mean Doppler gradient .35 to 40 mmHg), moderate-to-severe pulmonary regurgitation, presence of clinical symptomatology/New York Heart Association (NYHA) functional status, arrhythmia burden, and RV size and function should be evaluated when deciding to proceed with TPVR. Two systems are currently approved in the United States by the Food and Drug Administration (FDA) for treatment of dysfunctional surgical RVOT conduits or bioprosthetic valves: Melody (Medtronic, Inc. Minneapolis, MN, approved in 2010) and Edwards Sapien XT (Edwards Lifesciences, Inc., Irvine, CA, approved in 2016). However, it is estimated that only a small percentage of patients in need of RVOT therapy may be suitable for currently approved TPVR systems. Therefore off-label use of currently approved systems is commonplace. Clinical trials are being conducted to evaluate the Edwards Sapien 3 valve in the pulmonary position, as are trials of newly designed self-expanding stented valve systems to treat the dilated “native” RVOT with severe pulmonary regurgitation (such as the Alterra Adaptive Prestent [Edwards] designed for Sapien implant and the Harmony Valve [Medtronic, Inc].

AHA Guidelines

Recommendations in TOF

Pulmonary valve replacement (surgical or percutaneous) for relief

of symptoms is recommended for patients with repaired TOF and moderate or greater pulmonary regurgitation (PR) with cardiovascular symptoms not otherwise explained

Pulmonary valve replacement (surgical or percutaneous) is reasonable

for preservation of ventricular size and function in asymptomatic patients with repaired TOF and ventricular enlargement or dysfunction and moderate or greater PR

Recommendations in Isolated PR After Repair of PS

In symptomatic patients with moderate or greater PR resulting

from treated isolated pulmonary stenosis with RV dilatation or RV dysfunction, pulmonary valve replacement is recommended

I B-NR

IIa B-NR

I C-EO

Preprocedure Planning

Once a decision is made to proceed with TPVR, careful multimodality imaging assessment of the RVOT is necessary. Computed tomography with angiography (CTA) is useful for preprocedural imaging in most patients. Careful attention to the anatomy of the RVOT and PA branches is necessary, in addition to evaluation of surrounding cardiac structures, such as coronary artery origins and course in relationship to the RVOT and anticipated implant site. Three-dimensional reconstruction is useful for procedural planning, and evaluation of PA branch anatomy is recommended to determine if branch stent implantation will be needed. It is estimated that approximately 5% of patients who undergo this type of RVOT intervention are at risk for coronary compression, especially those patients in whom coronary artery manipulation or reimplantation has been performed (e.g., Ross procedure).

Device selection is typically based on the size of the existing RVOT conduit or bioprosthetic valve. The Melody valve is designed for implantation using the 22F Ensemble II delivery system (Medtronic, Inc., Minneapolis, MN), which comes with 18-, 20-, and 22-mm implant balloon diameters. The approved Sapien XT is available in 20-, 23-, 26-, and 29-mm diameters and is

338 8—ACHD INTERVENTIONS

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implanted on the NovaFlex catheter system; however, in many institutions at this time the Sapien S3 is being used in an off-label fashion.

Basic Procedure

General anesthesia is typically used for complex RVOT intervention and valve implantation; however, deep sedation in the adult congenital patient may be preferred to maintain baseline hemodynamics. The femoral approach is typical, although internal jugular access can be utilized. A 14 French sheath for initial right heart hemodynamics, angiography, and potential balloon interrogation of the RVOT should be sufﬁcient. Once a decision is made to proceed with valve therapy, this can be changed to a large-bore venous access; a 22 French Edwards dry seal will accommodate the Melody valve Ensemble delivery system. We recommend a 65-cm 26 French Edwards dry seal sheath positioned into the RVOT/pulmonary annulus landing zone for Sapien implantation. A large-bore venous sheath is placed, and the patient is fully heparinized to maintain an activated clotting time (ACT) greater than 250 seconds. Additional venous access is planned depending on the need for angiography and/or pacing during prestent or valve deployment. Preprocedure antibiotics are administered. Arterial access is necessary for aortic root angiography, selective coronary angiography, and arterial pressure monitoring during intervention.

Standard right heart catheterization is performed along with angiographic assessment of the

RVOT. RV angiography may be performed with a standard balloon-tipped angiographic or a pigtail catheter; alternatively, a multitrack catheter can be used for injection over the guidewire if this wire is positioned before angiography (Fig. 28.4). A balloon-tipped wedge catheter is used to achieve a distal position in a branch PA for anchoring of the exchange guidewire. The use of an angled Glidewire through the end hole of the wedge catheter facilitates positioning deep into a lower lobe PA branch; some prefer the left PA, as it is easier to visualize the wire tip during subsequent catheter manipulations. A 0.0350 exchange-length stiff guidewire is positioned into the distal PA branch (such as the Lunderquist [Cook, Bloomington, IN]).

Fig. 28.4 Main pulmonary artery (MPA) angiogram (lateral projection) in a patient who previously underwent a Ross procedure, now with dysfunctional, stenotic pulmonary homograft. There is also severe pulmonary regurgitation with contrast ﬁlling the right ventricular outﬂow tract (RVOT) in addition to moderate narrowing of the homograft (arrow).

28—PULMONARY VALVE INTERVENTIONS 339

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Depending on the nature of the existing RVOT conduit, preparation with prestenting may be necessary. Stenting should be performed when planning Melody valve implantation into a nonstented conduit, such as a homograft, to minimize the risk of subsequent Melody valve stent fracture that may lead to structural failure over time. Implantation of a longer bare-metal stent may provide a better “landing zone” for the shorter Sapien XT valve, but prestenting is not necessary to provide support for the frame of this valve. It is not common in our practice to prestent for preparation when implanting a Sapien valve. Certain types of bioprosthetic valves can be fractured prior to TPVR; typically a high-pressure balloon 1 mm larger than the labeled valve size is utilized. This allows expansion of the surgical valve to accommodate a slightly larger implant. In general, when implanting into a bioprosthetic valve, a prestent is not necessary. However, certain types of bioprosthetic valves may be fractured with high-pressure balloon dilation prior to TPVR to allow better expansion of implanted valve. Tips:

1. Guidewire position is critical: Care to achieve a secure distal wire position in a deep PA

branch will facilitate RVOT intervention, especially in the setting of signiﬁcant conduit stenosis. The left lower lobe PA is often preferred.

2. Gentle inflation of the balloon on the wedge catheter in the distal PA during

guidewire positioning can help secure the most distal position for a stiff exchange guidewire.

3. Serial inﬂation of noncompliant balloons in a stenotic/calciﬁed RVOT homograft con-

duit, beginning with a diameter approximately 110% of the minimum existing conduit diameter, is usually necessary to avoid conduit tear or rupture. Angiographic assessment between serial inﬂations should be performed to evaluate conduit disruption, and increasing balloon size should be performed in a small, stepwise fashion to avoid signiﬁcant disruption. If early conduit disruption is seen and coronary artery anatomy is unfavorable

surgery for deﬁnitive therapy. Otherwise, full rehabilitation of the conduit should be achieved before Melody valve implantation with high-pressure, noncompliant balloon dilation of ﬁnal stents to evaluate for recoil. Additional bare-metal stents may be needed to prevent conduit recoil once a covered stent is implanted.

4. Covered stents (i.e., Cheatham Platinum Stent System, B. Braun Medical, Inc., Bethlehem, PA)

should be available to the operator, particularly when rehabilitating a signiﬁcantly narrowed conduit, such as a homograft, where signiﬁcant conduit disruption can result in fatal hemorrhage if not able to be treated rapidly.

5. Selective coronary angiography may be necessary during RVOT balloon inﬂation to evalu-

ate the potential for compression if precatheterization CTA or baseline coronary angiography suggests risk with coronary proximity to the landing zone of the planned TPVR. The use of more dilute contrast in the RVOT balloon will allow visualization of the coronary artery during angiography. Often, a very “laid-back” view of the RVOT with caudal angulation showing the left coronary artery beneath is helpful (Fig. 28.5A and B). The patient who has undergone a Ross procedure or coronary reimplantation/manipulation may be at higher risk of this complication.

6. For optimal TPVR function, nearly complete relief of the RVOT gradient is best. This

is accomplished with placement of serial bare-metal stents (and/or covered stent depending on the nature of the conduit) to the point that there is minimal stent recoil upon deﬂation of the stent deployment balloon (Fig. 28.6). Therefore, during stent deployment, the response of the stent should be evaluated during balloon deﬂation, not just during inﬂation.

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A B

Fig. 28.5 (A) AP projection of selective left coronary angiogram during inﬂation of high-pressure Atlas balloon (22-mm diameter) in right ventricular outﬂow tract to document patency of the left main and branch coronary arteries during noncompliant balloon testing of right ventricular outﬂow tract. (B) Lateral projection in same patient.

Fig. 28.6 (A) Lateral projection showing ﬁnal Melody (darker stent) implant position within existing bare-metal stent (Melody implant balloon still present over wire). (B) Final main pulmonary angiogram showing competent Melody valve leaﬂets with trace pulmonary regurgitation (wire and catheter still through valve leaﬂets).

7. Implantation of either the Melody or Sapien into an existing bioprosthetic valve is rela-

tively straightforward and may be treated as a typical valve-in-valve procedure (Fig. 28.7).

Any conduit stenosis beyond the existing bioprosthetic valve should be treated with

stent implantation, but stenting of the bioprosthetic valve before TPVR is not generally

necessary.

8. A 26 Fr 65-cm GORE® DrySeal Flex Introducer Sheath (W. L. Gore & Associates, Inc.,

Flagstaff, AZ) is always used in our center for Sapien valve implantation to facilitate posi-

tioning of the valve into the RVOT, also to avoid damage to tricuspid apparatus (tricuspid

valve and RVOT crossed with balloon catheter to prevent catheter course through valve

chordae) (Fig. 28.8).

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A B

Fig. 28.7 (A) Anteroposterior (AP) projection showing wire position deep in the right pulmonary artery with Sapien valve/balloon system advanced into existing 33-mm Carpentier–Edwards bioprosthetic pulmonary valve (arrow). Pusher catheter has been withdrawn before delivery of valve (asterisk). (B) Balloon inﬂation to deliver 29-mm Sapien valve within existing bioprosthetic valve (arrow).

& Associates, Inc., Flagstaff AZ) technique for delivery of Sapien S3 mounted on the balloon outside the patient. RVOT calciﬁed homograft conduit has been pre-stented with a Covered CP Stent™ (NuMED Inc. Hopkinton, NY) into which the Sapien valve is advanced with the DrySeal as protection; the sheath is withdrawn below the proximal end of the balloon for valve deployment.

Potential Procedural Complications

All planned TPVR procedures should be considered with potential complications in mind. As previously mentioned, coronary artery compression may be the most signiﬁcant, potentially fatal complication of RVOT intervention. Other complications that can occur with deployment of a transcatheter valve include (but are not limited to) vascular injury, valve embolization, jailing of PA branches, and distal PA complications due to wire perforation. Therefore a skilled heart team approach is necessary for successful implementation of a transcatheter pulmonary valve program. Surgical backup and potential mechanical support should be available, particularly for the high-risk patient.

DrySeal Flex Introducer Sheath (W. L. Gore

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Postprocedure Management

Noninvasive echocardiography is essential for documentation of baseline TPVR function, determination of Doppler gradient, degree of valvular regurgitation, and follow-up of RV size and function. As RV remodeling occurs after pulmonary valve insertion, tricuspid valve regurgitation may improve. Serial imaging is necessary, with annual follow-up recommended. For patients who underwent signiﬁcant RVOT rehabilitation, including the placement of multiple stents before valve implantation, routine chest radiography should be performed, with consideration of periodic ﬂuoroscopic imaging to evaluate stent integrity, particularly if valve dysfunction is suspected or seen. All patients should be treated with antiplatelet therapy, typically aspirin, and should observe lifelong infective endocarditis precautions. Valve durability is expected to be similar to surgically placed bioprosthetic valves.

Summary

Percutaneous PBA is safe and effective, with acute success rates between 80% and 90%.

TPVR therapy is now an important part of intervention for patients with both congenital

and acquired pulmonary valve dysfunction.

Interventions should be performed by a pediatric interventional specialist or as part of a

multidisciplinary structural heart team that includes an experienced pediatric congenital interventionalist.

Further Reading

Allen KB, Chhatriwalla AK, Cohen DJ, et al. Bioprosthetic valve fracture to facilitate transcatheter valve-in-

valve implantation. Ann Thorac Surg. 2017;104(5):1501-1508.

Ansari MM, Cardoso R, Garcia D, et al. Percutaneous pulmonary valve implantation: present status and

evolving future. J Am Coll Cardiol. 2015;66(20):2246-2255.

Armstrong AK, Balzer DT, Cabalka AK, et al. One-year follow-up of the Melody transcatheter pulmonary

valve multicenter post-approval study. JACC Cardiovasc Interv. 2014;7:1254-1262.

Bergersen L, Benson LN, Gillespie MJ, et al. harmony feasibility trial: acute and short-term outcomes with

a self-expanding transcatheter pulmonary valve. JACC Cardiovasc Interv. 2017;10(17):1763-1773.

Cabalka AK, Hellenbrand WE, Eicken A, et al. Relationships among conduit type, pre-stenting, and out-

comes in patients undergoing transcatheter pulmonary valve replacement in the prospective North American and European Melody valve trials. JACC Cardiovasc Interv. 2017;10(17):1746-1759.

Cabalka AK, Asnes JD, Balzer DT, et al. Transcatheter pulmonary valve replacement using the Melody valve

for treatment of dysfunctional surgical bioprostheses: a multicenter study. J Thorac Cardiovasc Surg. 2018;155(4):1712-1724.

Cheatham JP, Hellenbrand WE, Zahn EM, et al. Clinical and hemodynamic outcomes up to 7 years after

transcatheter pulmonary valve replacement in the US Melody valve investigational device exemption trial. Circulation. 2015;131:1960-1970.

Haas NA, Carere RG, Kretschmar O, et al. Early outcomes of percutaneous pulmonary valve implantation

using the Edwards SAPIEN XT transcatheter heart valve system. Int J Cardiol. 2018;250:86-91.

Liu S, Xu X, Liu G, et al. Comparison of immediate and long-term results between the single balloon and

Inoue balloon techniques for percutaneous pulmonary valvuloplasty. Heart, Lung Circ. 2015;24:1.

McElhinney DB, Hellenbrand WE, Zahn EM, et al. Short- and medium-term outcomes after transcatheter

pulmonary valve placement in the expanded multicenter US Melody valve trial. Circulation. 2010;122:507-516.

O’Byrne ML, Glatz AC, Mercer-Rosa L, et al. Trends in pulmonary valve replacement in children and adults

with tetralogy of Fallot. Am J Cardiol. 2015;115:118-124.

Wilson WM, Benson LN, Osten MD, et al. Transcatheter pulmonary valve replacement with the Edwards

Sapien system: the Toronto experience. JACC Cardiovasc Interv. 2015;8(14):1819-1827.

Zahn EM, Chang JC, Armer D, Garg R. First human implant of the Alterra Adaptive PrestentTM: a new

self-expanding device designed to remodel the right ventricular outﬂow tract. Catheter Cardiovasc Interv. 2018;91(6):1125-1129.

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Abstract: Transcatheter pulmonary valve replacement is an important technology for application to patients with both complex congenital and acquired right ventricular outﬂow tract abnormalities. Catheter-based rehabilitation of right ventricular outﬂow tract conduits is a technically demanding procedure that requires a comprehensive congenital team approach.

Keywords: Pulmonary stenosis, pulmonary regurgitation, right ventricular outﬂow tract, transcatheter pulmonary valve replacement, transcatheter valve therapy

CHAPTER 29

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Pseudoaneurysm Diagnosis and Management

Kashish Goel Mohammed Al-Hijji Charanjit S. Rihal

Introduction

Cardiac pseudoaneurysms are an uncommon occurrence; however, they are associated with signiﬁcant risk of complications. or myocardial wall. A single layer of pericardium or adhesions lines the sac, increasing the risk of rupture and cardiac mortality approaching 30% to 50%. rysm, which is thinning of the wall and contains all three layers of the endocardium, myocardium, and epicardium.

Previously, surgical management of pseudoaneurysms was considered the gold standard; however, it is associated with signiﬁcant mortality approaching 23%. structural heart procedures has helped in identifying percutaneous solutions for the management of pseudoaneurysms in patients who otherwise have high surgical risk. This chapter will discuss the various techniques and approaches for the diagnosis and management of pseudoaneurysms.

2,4

1,2

A pseudoaneurysm is a contained rupture of the arterial vessel

This is in comparison to a true aneu-

1,5

Recent growth of

Incidence, Presentation, and Natural History

There are no prospective studies evaluating the natural history of pseudoaneurysms because of the low incidence. Retrospective studies have suggested that many patients are asymptomatic, with diagnosis made as an incidental ﬁnding on imaging. failure, chest pain, syncope, arrhythmias, or thromboembolism (Table 29.1). Recently, cases re- lated to wire perforations/injury during structural heart procedures such as transcatheter aortic valve replacement (TAVR) and mitral valve replacements have also been reported.

The left ventricle (LV) is the most common location of pseudoaneurysms. The etiology of LV pseudoaneurysms is variable according to the location. Myocardial infarction (MI) is the most common etiology, usually leading to an inferior-posterolateral scar and subsequent pseudoaneurysm formation. Cardiovascular surgery is the second most common cause. Right ventricular pseudoaneurysm is frequently seen with congenital surgeries, and paravalvular pseudoaneurysm,

TABLE 29.1 n Clinical Presentation of Pseudoaneurysm

Acute complication of myocardial infarction Post-structural heart procedures Heart failure Dyspnea Chest pain