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Catheter Management Pulmonary Valvular Disorders
Introduction
Advances in pediatric cardiology, cardiac surgery, and perioperative care have dramatically improved long-term survival for children born with congenital heart disease. As a result, the prevalence of congenital heart disease in the adult population has risen to approximately 1 in 150, with roughly half of these patients having undergone at least 1 surgical repair in childhood. A significant proportion will require reintervention during adulthood.[1][2]
The right ventricular outflow tract (RVOT) is involved in about 20% of newborns with congenital heart disease, encompassing lesions such as tetralogy of Fallot, truncus arteriosus, pulmonary atresia with ventricular septal defect, and others. Surgical palliation of these defects commonly requires reconstruction with bioprosthetic valves, transannular patches, or extracardiac conduits between the right ventricle and the pulmonary artery.[3] These conduits are typically necessary when an anomalous left anterior descending coronary artery arising from the right coronary artery crosses the RVOT, precluding safe transannular patch repair. Although these conduits initially restore pulmonary valve competence, they undergo progressive calcification, intimal proliferation, and somatic growth, limiting long-term durability and often necessitating reintervention.[4]
Conduit dysfunction is multifactorial and depends on the patient’s age at implantation, the underlying defect, tissue type, surgical technique, and material used. Homograft valves, in particular, tend to degenerate, leading to significant pulmonary regurgitation, pulmonary stenosis, or mixed lesions, with roughly half of patients eventually requiring further intervention.[5][6] Surgical reoperation carries substantial morbidity and mortality risks related to dense adhesions, cardiac injury, ischemia, heart failure, and multi-organ dysfunction.[7][8][9][10][11][12]
Earlier repairs for tetralogy of Fallot that relied on generous transannular patches often resulted in free pulmonary insufficiency, progressive right ventricular dilation, tricuspid annular enlargement with regurgitation, and an arrhythmic substrate that can contribute to sudden cardiac death. Balloon angioplasty and bare-metal stenting were important early advances but often left significant residual pulmonary regurgitation. Transcatheter pulmonary valve implantation (TPVI) has emerged as a common, less invasive option in adult congenital heart disease. This procedure allows earlier restoration of pulmonary valve function before irreversible right ventricular remodeling sets in and may reduce the lifetime number of open surgical procedures.[13][14][15][16]
Anatomy and Physiology
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Anatomy and Physiology
The pulmonary valve is located between the right ventricle and the main pulmonary artery and normally consists of 3 thin semilunar cusps that permit unidirectional blood flow into the pulmonary circulation (see Image. Transverse Cross Section of the Heart). Congenital RVOT abnormalities, such as tetralogy of Fallot, pulmonary atresia, truncus arteriosus, or isolated pulmonary valve stenosis, often require surgical reconstruction with right ventricle-to-pulmonary artery conduits, transannular patches, or bioprosthetic valves. Over time, these repairs often fail due to calcification, stenosis, regurgitation, or conduit degeneration, leading to progressive right ventricular dilation, dysfunction, arrhythmias, and exercise intolerance. A thorough understanding of RVOT anatomy, conduit characteristics, coronary artery relationships, branch pulmonary artery anatomy, and prior surgical repairs is essential for appropriate patient selection and procedural planning for TPVI.
Optimal anatomy for TPVI depends on the transcatheter valve system used. Balloon-expandable valves are primarily indicated for dysfunctional RVOT conduits measuring at least 16 mm in diameter, where a stable landing zone can be achieved. In contrast, self-expanding valves and self-expanding stents followed by balloon-expandable valve implantation are approved and routinely used in patients with native or patched RVOTs following transannular patch repair, accommodating the larger, more variable geometry commonly encountered in these patients.[17][18][19] Off-label use in smaller conduits or complex RVOT anatomies may be considered at experienced centers when anatomic characteristics are otherwise favorable and surgical risk is prohibitive. Preprocedural imaging with echocardiography, cardiac computed tomography, and cardiac magnetic resonance imaging is critical for defining RVOT dimensions, assessing calcification, identifying conduit morphology, evaluating branch pulmonary arteries, and excluding coronary artery compression during valve deployment, thereby ensuring safe device selection and optimal procedural outcomes.
Indications
Optimizing the timing for RVOT intervention remains challenging. Standard TPVI criteria closely mirror those for surgical pulmonary valve replacement and focus on right ventricular volumetric data, systolic function, significant tricuspid regurgitation, RVOT obstruction, arrhythmias, QRS duration, and residual intracardiac defects. In asymptomatic patients with moderate to severe pulmonary regurgitation, TPVI is generally indicated when 1 or more of the following are present:
- Significant right ventricular dilation (right ventricular end-diastolic volume index >150–160 mL/m² or right ventricular end-systolic volume index >80 mL/m²)
- Right ventricular systolic dysfunction (ejection fraction <45%)
- Persistent atrial or ventricular arrhythmias
- RVOT obstruction with right ventricular systolic pressure greater than two-thirds systemic or >80 mm Hg
- Progressive tricuspid regurgitation
- Symptoms with moderate to severe pulmonary regurgitation/pulmonary stenosis and right ventricular systolic pressure >60 mm Hg [20][21]
The 2025 American College of Cardiology/American Heart Association/Heart Rhythm Society/International Society for Adult Congenital Heart Disease/Society for Cardiovascular Angiography and Interventions (ACC/AHA/HRS/ISACHD/SCAI) guideline assigns the following classes:
- Class 1 recommendation for pulmonary valve replacement (surgical or transcatheter) in symptomatic individuals with severe pulmonary regurgitation or pulmonary stenosis.
- Class 2a recommendation supports intervention in asymptomatic individuals with moderate or greater pulmonary valve dysfunction plus progressive right ventricular dilation, systolic dysfunction, or arrhythmias.
Guidelines from various societies continue to weigh risk factors such as age at initial repair, electrophysiologic markers (including QRS duration as a predictor of arrhythmic risk and sudden cardiac death), and the hemodynamic consequences of severe pulmonary regurgitation. Once clinical criteria are met, a detailed anatomic assessment of RVOT morphology is mandatory to determine the feasibility of TPVI.[22]
Contraindications
Active infection and occluded central venous access are absolute contraindications for TPVI. Unfavorable coronary artery anatomy that would result in coronary compression during balloon testing or device deployment is also an absolute contraindication and must be meticulously excluded. An RVOT diameter exceeding the largest available valve size prevents secure anchoring. Recurrent infective endocarditis and active intravenous drug use increase long-term infection risk and are often considered relative contraindications requiring careful shared decision-making.[20][22]
Equipment
Balloon-expandable valves were the first transcatheter systems approved for pulmonary use (see Image. Catheter Management of Pulmonary Valvular Disorders).[19] Experience has shown TPVI to be less invasive than surgery, with lower risks of bleeding, infection, and bypass-related morbidity. Two broad device categories are now used: balloon-expandable valves and self-expanding valves.
Balloon-expandable valves
Balloon-expandable valves remain the most commonly implanted. In patients with large, irregular, or heavily calcified homografts and right ventricular-to-pulmonary artery conduits at high risk of disruption during dilation, a self-expanding covered aortic endoprosthesis can first be deployed to create a stable, protected landing zone before balloon-expandable valve implantation. This strategy has proven feasible and effective for preparation of failed (stenotic or regurgitant) pulmonary homografts or right ventricular-to-pulmonary artery conduits.[23] A modified deployment technique for the self-expanding endoprosthesis, which adjusts the retention sleeve to improve anchoring, helps prevent graft displacement during delivery-system removal and has expanded its utility in congenital applications.[24]
Self-expanding valves
In select cases with very large native or patched RVOTs, dedicated self-expanding valves or self-expanding stents are used, followed by implantation of a balloon-expandable valve.[19] When the central RVOT is too wide, but the branch pulmonary arteries are suitable, bilateral implantation of branch pulmonary artery valves has been described, though it remains uncommon. Additional equipment includes extra-stiff guidewires, pigtail catheters for angiography, medium- and high-pressure balloons for sizing, predilation and postdilation, large sheaths, self-expanding endografts, and covered or bare-metal stents when further landing zone preparation is required.[19][23] Suture-mediated vascular closure devices are routinely used for hemostasis.[25]
Personnel
A cardiac team comprising interventional cardiologists, cardiac surgeons, noninvasive cardiologists, and cardiac anesthesiologists is crucial to achieving the best possible outcome for this complex procedure. This team should be experienced in treating RVOT interventions. In addition, consider extracorporeal membrane oxygenation (ECMO) facilities in the event of significant instability or deterioration, although the need for ECMO support with this procedure is quite rare.
Pediatric or interventional cardiologists with expertise in cardiac magnetic resonance imaging, cardiac computed tomography, and echocardiography are extremely helpful for preprocedure assessment and planning. Nurses must be available for pre- and post-procedure care, including assessing vital signs, performing baseline laboratory tests, confirming the patient’s ABO-Rh blood group, determining baseline renal function, and maintaining hydration. Nursing staff handles pre- and post-procedure care, including laboratory evaluation, hydration, blood readiness, and vigilant monitoring for complications.
Preparation
A detailed review of the patient’s history, with a thorough understanding of cardiac anatomy and specific attention to details of previous surgical interventions (ie, type of RVOT reconstruction, conduit size, conduit type, intraoperative concerns or challenges), is crucial. Review of other available diagnostic studies, such as previous hemodynamic evaluations, echocardiography, electrocardiograms, stress tests, and cross-sectional imaging with either cardiac magnetic resonance (CMR) imaging or computed tomography (CT), is crucial.[26][27] Specific attention to detail, including biventricular function, RVOT morphology, the degree of RVOT stenosis and/or regurgitation (spectral Doppler evaluation), and tricuspid regurgitation, should be assessed with echocardiography.[28][29][30] Considering potential routes for vascular access—such as the femoral or internal jugular veins or a hybrid approach—helps ensure vessel patency.
The preferred approach may depend on several factors, such as RVOT morphology, RVOT compliance and distensibility, and coronary artery anatomy. CT or MRI cross-sectional imaging with 3-dimensional reconstruction can help assess RVOT morphology, conduit type, and the degree of calcification.[18][31] The most challenging morphology for transcatheter intervention is a pyramidal shape that is narrow distally and wide proximally.
In contrast, patients with a homograft or conduit in place are conventionally more suitable.[32][33][34][35] Another key determinant of suitability is RVOT compliance and distensibility. CMR can identify pulsatility, which CT cannot, while balloon testing can better assess RVOT distensibility. Device selection is guided by RVOT anatomy: self-expanding valves or self-expanding stents (followed by a balloon-expandable valve) are preferred for native or patched RVOTs, whereas balloon-expandable valves are standard for conduits and surgical bioprostheses.[19]
Technique or Treatment
Moderate sedation is usually employed for the procedure with on-site surgical support. In select cases, general anesthesia is used.[36] Various vascular access sites can be implemented, including femoral, jugular, and subclavian veins. Femoral access is the most common, although the jugular approach may allow a more desirable anatomical curvature for valve delivery in certain anatomic arrangements and may provide access to a larger vessel in smaller patients in whom femoral access may be prohibitive.
Before valve implantation, administer heparin to maintain an activated clotting time greater than 250 seconds, and typically give prophylactic antibiotics before placing any stents or hardware. Perform a right heart catheterization in the standard fashion, with pressure measurements throughout the right heart. When performing a right heart assessment, use a balloon-tipped catheter that, with the balloon inflated, crosses the largest effective orifice of the tricuspid valve. This helps prevent the catheter from traversing small spaces within the tricuspid valve chordae or right ventricular trabeculations, which could make it difficult to pass larger sheaths and/or damage the tricuspid valve.
Angiograms are typically performed in the main pulmonary artery and right ventricle in 2 projections, although in patients with severe pulmonary regurgitation, a single pulmonary artery angiogram may be sufficient. Very often, the anteroposterior projection is optimized with cranial angulation (20 to 30 degrees) to best profile the RVOT/conduit to most accurately determine the conduit’s length, diameter, and morphology. Typically, a straight lateral projection with the lateral camera nicely defines the conduit and the proximity to the sternum, which may help predict how and where the conduit will dilate during balloon testing.
Aortic root injection and, often, selective coronary angiography are also performed to assess the proximity of the coronary arteries to the conduit, as discussed below. When performing angiograms, it helps to leave a catheter and/or wire in the RVOT to identify the conduit's exact location relative to the coronary arteries. After determining whether reasonable clinical and/or hemodynamic criteria support intervention, consider how best to prepare the conduit for valve placement.
In contemporary practice, a self-expanding covered endograft is deployed across the entire conduit length to line it from within.[23][24] The conduit is then dilated with the largest appropriate noncompliant balloon to fracture the conduit and achieve full expansion. Balloon size is selected based on the dimension of the main pulmonary artery just distal to the conduit anastomosis.
In patients with complex congenital heart disease, the reported incidence of coronary artery compression during conduit dilation is approximately 5%.[37] To mitigate this risk, selective coronary angiography is performed simultaneously with balloon inflation. If compression is observed, the inflation is repeated with the next smaller balloon, and the sequence is continued until a diameter is identified at which the coronary artery is no longer compressed. Then, an appropriately sized balloon-expandable pulmonary valve is implanted inside the rehabilitated right ventricle-to-pulmonary artery conduit.[23]
This contemporary approach has shortened procedural time and improved safety. Previously, the conduit was dilated stepwise, beginning at the narrowest diameter and advancing in 2-mm increments, with selective coronary angiography after each inflation. A super-stiff wire is essential throughout this portion of the procedure, and the tip should be positioned as distally as possible within the pulmonary branch arteries. Assess aortic root compression, with or without coronary compression, during balloon sizing, as it may cause significant aortic insufficiency in patients with a native RVOT or a transannular patch.[37]
Following valve implantation, right heart hemodynamics are reassessed, and a pulmonary artery angiogram is repeated to confirm valve position, valve competence, and unobstructed branch pulmonary artery flow. Additional balloon dilation is occasionally required to optimize valve expansion or to address a residual gradient or paravalvular leak. Hemostasis is achieved with a figure-of-8 suture, a vascular closure device, or manual pressure, and bleeding from the venous access site is rarely problematic despite the use of large-bore sheaths.
Most patients are observed overnight and discharged the following morning, although selected patients can be discharged on the same day. We prescribe daily aspirin at discharge, and patients continue it indefinitely while the valve remains in place. Despite these technical considerations, the procedure has been performed successfully in more than 96% of patients with RVOT dysfunction.[36]
In patients with severe pulmonary regurgitation arising from a native RVOT, preprocedural cardiac CT is routinely obtained to characterize the outflow geometry and to guide device selection. Three-dimensional reconstruction enables accurate assessment of the minimum and maximum RVOT diameters, the outflow's conical or cylindrical morphology, the length of the available landing zone, and the RVOT's proximity to the proximal coronary arteries. These measurements inform the choice between two principal transcatheter strategies.
When the RVOT is tapered and dynamic, a self-expanding transcatheter pulmonary valve can be deployed directly into the native outflow tract without further preparation.[38][39] When the RVOT is more cylindrical or oversized, a self-expanding prestent is first deployed to establish a defined cylindrical landing zone, and a balloon-expandable transcatheter pulmonary valve is then implanted within the prestent waist.[40][41] Coronary artery and aortic root proximity are reviewed in advance using simulated balloon and valve positions on the reconstructed dataset, and any concern for compression prompts adjustment of device size or overall strategy before the procedure.[42]
Complications
Although uncommon, several potential procedural complications can occur in patients with severe right ventricular dysfunction; a stiff wire traversing the tricuspid valve, combined with pulmonary regurgitation, can cause tricuspid regurgitation, hypotension, and hemodynamic instability. More significantly, severe hemodynamic compromise may result from valve dislodgment into the pulmonary artery, causing obstruction of the pulmonary blood flow, coronary compression causing coronary ischemia, and conduit rupture causing major hemorrhage. However, these are fortunately rare. Heavy calcification and the presence of homograft conduits have been identified as risk factors for rupture.[43]
In homografts and conduits, pre- and post-deployment balloon dilations can cause rupture or tearing. Most cases can be managed successfully with a covered stent or self-expanding endograft.[23] Surgical bailout is rarely required following conduit rupture.[17][44] Valve migration/embolization remains a potentially serious procedural complication that may require surgical intervention; however, with adequate conduit assessment and RVOT preparation, this remains rare.
If this complication occurs, valve deployment into a branch pulmonary artery has been proposed as a potential remedy if the valve embolizes distally. Retrieval with deployment of the embolized valve into the inferior vena cava (IVC), followed by stenting to open the valve leaflets, has also been proposed. Still, this procedure carries a significant risk of injury to the tricuspid valve, right ventricle, and IVC.
Longer-term complications include stent fracture, which remains the most common reason for reintervention with first-generation valves, even despite prestenting (5%–16%). Risk factors include younger age, higher pre- and procedural RVOT gradient, smaller angiographic conduit diameter, valve position directly under the sternum, stent recoil, or compression after deployment.[44][45] Type I fracture consists of 1 strut disruption without loss of stent integrity.
Type II includes stent integrity loss, and type III includes fractures with fragment separation. Type I occurs in up to 40% of patients; however, this type is not usually associated with adverse effects. Type II and III stent fractures are associated with early conduit restenosis and valve failure and may require surgical replacement or repeat TPVI. Clinically significant stent fracture with the second-generation valve in the pulmonary position has not yet been reported.
More recently, the development of infective endocarditis has emerged as a significant risk, with an incidence of approximately 2.4% per patient-year. Male sex, multiple stents, unprotected dental treatment, previous history of endocarditis, and noncompliance with aspirin constitute the risk factors.[46][47][48][49] Percutaneous pulmonary valve (PPV) endocarditis is characterized by vegetation visualized on the implant or as new evidence of PPV dysfunction associated with bloodstream infection.[50]
A wide spectrum of organisms, ranging from coagulase-negative staphylococci to Haemophilus, Aggregatibacter (previously Actinobacillus), Cardiobacterium, Eikenella, Kingella (HACEK) organisms, can cause TPVI-related endocarditis. Streptococcus viridans and Staphylococcus aureus are the most common causes. Occasionally, clinicians can treat and clear this medically. However, due to significant postinfection valve dysfunction, many patients require surgical valve replacement even if the bloodstream can be cleared of infection.
Clinical Significance
A decade after its approval in the United States, TPVI has emerged as a safe, effective nonsurgical therapy for RVOT dysfunction, often producing a peak cath gradient of less than 35 mm Hg and no more than mild insufficiency, with a complication rate of 6% to 13%.[51][52][53] Several studies have demonstrated the procedure's clinical efficacy, highlighting its potential to reduce right ventricular pressure and the RVOT gradient and eliminate pulmonary regurgitation.[30][44][54][55] Percutaneous restoration of pulmonary valve function has also been shown to significantly decrease right ventricular dimensions, improve stroke volumes, and improve New York Heart Association (NYHA) functional classes.[51][56][57][58]
Furthermore, patients experience improved exercise capacity and peak oxygen consumption.[56][59][60][61] At 1 year, 93.5 ± 2.4% of patients were free of valve dysfunction or need for reintervention.[44] The postapproval study's results showed freedom from PPV dysfunction to be 96.9%. Thus, results from multiple studies have demonstrated excellent success rates, hemodynamic outcomes, and low complication rates.
The long-term rate of reintervention with the first-generation valve remains relatively low, with 1- and 5-year freedom from reintervention greater than 90% and 76%, respectively, excluding patients with stent fracture.[53] Several risk factors for the need for reintervention have been identified: lack of prestenting, presence of a homograft, moderate-to-severe preprocedural tricuspid valve insufficiency, and postintervention RVOT gradient greater than 25 mm Hg.[47][53][62] Long-term survival for patients receiving a valve is excellent at 98% and 97% at 5 and 7 years, respectively.[47][53]
Likewise, second-generation valves decrease the RVOT gradient and the degree of pulmonary regurgitation, improve NYHA functional class, and decrease right ventricular systolic pressure, right ventricle-pulmonary artery gradient, and pulmonary artery systolic pressure.[63][64] Technical success rates for second-generation valve implantation are equivalent to those for first-generation valves, at about 96%, with similar potential complications (stent migration, ventricular arrhythmia, and conduit rupture). The technical advantage is its ability to be implanted in larger conduits.[65][66] Freedom from reintervention at 6 months is about 97%. Thus, both valve systems show promising results, particularly when care is taken to adequately prepare the existing conduit, especially when it presents with severe conduit stenosis.
Enhancing Healthcare Team Outcomes
Optimal catheter-based management of pulmonary valvular disorders requires coordinated collaboration among interventional cardiologists, congenital heart disease specialists, cardiothoracic surgeons, cardiac imaging specialists, anesthesiologists, advanced practice providers, nurses, pharmacists, and cardiac technologists. Successful patient selection depends on accurate assessment of right ventricular outflow tract anatomy, multimodality imaging, hemodynamic evaluation, and application of evidence-based criteria to determine the most appropriate transcatheter intervention. Advanced practice providers facilitate preprocedural evaluation, patient education, longitudinal follow-up, and surveillance coordination.
At the same time, nurses provide procedural preparation, intraoperative monitoring, patient education, and early recognition of vascular, bleeding, rhythm, or valve-related complications. Imaging specialists play a critical role in procedural planning by evaluating right ventricular outflow tract dimensions, conduit morphology, coronary artery relationships, and device suitability. A strategic, multidisciplinary approach enhances procedural safety and long-term outcomes through standardized protocols, shared decision-making, and clear communication before, during, and after intervention.
Pharmacists optimize antithrombotic therapy, antibiotic prophylaxis when indicated, medication reconciliation, and perioperative medication management while monitoring for drug interactions and adverse effects. Cardiac technologists and catheterization laboratory staff ensure appropriate equipment selection, device preparation, radiation safety, and procedural efficiency. Regular multidisciplinary heart team conferences facilitate collaborative treatment planning for complex anatomy and high-risk individuals, while coordinated postoperative surveillance enables early detection of valve dysfunction, endocarditis, arrhythmias, and right ventricular deterioration. Effective interprofessional communication and coordinated longitudinal care improve patient-centered outcomes, procedural success, patient safety, and overall team performance.
Media
(Click Image to Enlarge)
Transverse Cross Section of the Heart. This illustration highlights the anatomical features visible in a transverse cross section of the heart. This picture includes both atria and auriculae, the left and right pulmonary veins, the superior vena cava, and the aortic and pulmonary valves.
Henry Vandyke Carter, Public Domain, via Wikimedia Commons
(Click Image to Enlarge)
Catheter Management of Pulmonary Valvular Disorders. This illustration shows the balloon inflated within the pulmonary valve.
StatPearls Publishing Illustration
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