INTRODUCTION — Percutaneous pulmonic valve implantation (PPVI) was developed as a nonsurgical treatment for patients with right ventricular outflow tract (RVOT) dysfunction [1]. PPVI devices are intended for use in a dysfunctional (stenotic or regurgitant) right ventricle-to-pulmonary artery conduit. PPVI is intended to extend the lifetime of a right ventricle-to-pulmonary artery conduit and hence reduce the total number of open-heart surgeries required over a patient’s lifetime.
Some centers have extended the application of PPVI to treat patients with tetralogy of Fallot without a conduit [2,3] and to treat patients with tetralogy of Fallot with failing pulmonic bioprosthetic valves [4,5].
INDICATIONS AND EXCLUSIONS
Our approach — We recommend PPVI for patients with right ventricle to pulmonary artery conduits, native right ventricle outflow tracts, or failing bioprosthetic valves in the pulmonary position meeting the following criteria for severe right ventricular outflow tract (RVOT) obstruction or severe pulmonic regurgitation [3,4,6-8]:
●Severe RVOT obstruction (as defined in the bullets below) with no or mild pulmonary regurgitation:
•With normal RV systolic function
-Symptoms (<65 percent of expected exercise tolerance) related to RVOT obstruction plus a peak continuous wave Doppler velocity of >3.5 m/s.
or
-No symptoms plus RVOT obstruction with peak continuous wave Doppler velocity >4.0 m/s or RVOT obstruction with right ventricular systolic pressure greater than two-thirds of systemic systolic pressure.
•With RV systolic dysfunction – Generally similar thresholds are used as with normal RV systolic function. However, some patients with severe RV systolic dysfunction may have severe RVOT obstruction with gradients that do not meet the standard thresholds for intervention due to low cardiac output; some of these patients may benefit from PPVI, although data are lacking to support this approach.
●Severe pulmonary regurgitation and little or no RVOT obstruction, with either symptoms, arrhythmias, or right ventricular end-diastolic volume index >150 cm/m² by cardiovascular magnetic resonance imaging.
Candidates for PPVI must also meet the following two criteria:
●Adequate RVOT conduit size to accommodate a covered stent. We do not have a lower size limitation. The upper size limitation is usually a diameter <29 mm. In selected cases, a slightly larger diameter may be successfully treated after pre-stenting to a smaller diameter to create a suitable "landing zone" or by overdilating an Edwards SAPIEN valve 29 to 31 mm.
●Adequate body size. There is no absolute lower age limit but an adequate body size (eg, weight >20 kg) is required to accommodate femoral placement of the introducer [7].
The following exclusion criteria are adapted from the 2010 European Society of Cardiology (ESC) guidelines for the management of grown-up congenital heart disease endorsed by the Association for European Pediatric Cardiology (AEPC) [8,9]:
●Evidence of risk of coronary compression by the expanded implant as determined by balloon testing (image 1) [10].
●Central vein occlusion or significant obstruction.
●Active infection (such as endocarditis) or high risk of infection (such as intravenous drug abuse).
●Surgery is preferred when additional interventions are considered such as tricuspid annuloplasty, coronary artery bypass, or arrhythmia surgery.
Major society guidelines — The 2010 ESC/AEPC guidelines for the management of grown-up congenital heart disease include the following indications for surgical intervention or PPVI in patients with right ventricular to pulmonary artery conduits [9]:
●Intervention is recommended in symptomatic patients with RV systolic pressure >60 mmHg (TR velocity >3.5 m/s; may be lower in cases with reduced flow) and/or moderate to severe pulmonic regurgitation.
●Intervention is suggested in asymptomatic patients with severe RVOT obstruction and/or severe pulmonic regurgitation when at least one of the following criteria is present:
•Decrease in exercise capacity on cardiopulmonary exercise testing
•Progressive RV dilation
•Progressive RV systolic dysfunction
•Progressive TR (at least moderate)
•RV systolic pressure >80 mmHg (TR velocity >4.3 m/s)
•Sustained atrial/ventricular arrhythmias
IMPLANTATION TECHNIQUE — Two different types of valves are commercially available for PPVI, the Medtronic Melody Transcatheter Pulmonary Valve and the Edwards SAPIEN Pulmonic Transcatheter Heart Valve. Initial results of a third self-expandable valve for right ventricular outflow tract (RVOT)-dysfunction are available [11,12].
The implantation technique for the two valves for PPVI is similar [1,7,10,13-16]. PPVI is usually performed using general endotracheal anesthesia or conscious sedation. Venous access is generally obtained through the femoral vein, although a jugular venous approach is also feasible. After a complete hemodynamic and angiographic study, a guidewire is positioned distally into a pulmonary artery.
Balloon test — Because coronary compression is a serious complication of PPVI, a balloon test to exclude potential coronary artery compression should always be performed. This involves inflation of a balloon in the RVOT conduit. During balloon inflation, an aortogram is obtained to display the coronary arteries (image 1) [10]. If coronary artery flow is impaired during this test, PPVI should not be performed. For this test, an aortogram may be preferable to selective coronary artery angiogram because intubation of the coronary artery by the catheter may lead to a false negative test. Initially, the balloon test is done with a low pressure balloon to prevent the risk of conduit rupture. The balloon diameter equals the intended external diameter of the landing zone for the pulmonic valve. In case of close proximity of the coronary arteries, a balloon test with a high pressure balloon (ie, Atlas Kevlar balloons) may be indicated as well as selective coronary angiograms in multiple planes.
Pre-stenting — Observational studies have found that pre-stenting of the conduit before PPVI is associated with a lower risk of developing PPVI stent fractures with the Melody valve [17]. Therefore, pre-stenting of the conduit before PPVI is now standard practice in most centers. Usually, a covered stent is preferred to avoid bleeding out of the ruptured conduit during deployment of the stent, because high-pressure balloons are needed to dilate the conduit to the previously tested diameter. In some cases (eg, long stenosis or significant recoil during balloon deflation), additional stents are needed for pre-stenting to support the landing zone. A non-covered stent is usually used if obstruction of the origin of one of the pulmonary branch arteries ("jailing") is expected after deployment of the pre-stent.
Valve types — Depending on the final diameter of the treated RVOT, either a Melody valve (balloon diameter 18, 20, or 22 mm and external valve diameter 20 to 24 mm) or a SAPIEN valve (23, 26, or 29 mm) is chosen.
The Medtronic Melody Transcatheter Pulmonary Valve (image 2) is available in two sizes (20 and 22). The 20 mm valve can be implanted with a diameter of 18 or 20 mm balloon and the 22 mm valve with an 18, 20, or 22 mm delivery system. The Melody valve consists of a 34 mm bare metal Cheatham platinum stent (NuMED CP Stent CP8Z34) into which a Medtronic Contegra bovine jugular venous valve is hand-sewn. The valve is crimped onto a designated double balloon delivery system requiring a 22F sheath.
The Edwards SAPIEN Pulmonic Transcatheter Heart Valve (THV) (image 3) is available in three sizes, 23, 26, and 29 mm. The SAPIEN valve is made of a trileaflet bovine pericardial valve hand-sewn into a stainless-steel stent. There is a fabric-sealing cuff covering the proximal part of the stent designed to prevent paravalvular leaking. The valve is crimped onto a designated balloon delivery system requiring a 14 or 16F sheath for the 23, 26, or 29 mm valve. The SAPIEN THV is advanced without protection into the RVOT. If the THV struts get caught in the tricuspid valve, the valve may be damaged [18]. To avoid this complication, some have advocated use of a large sheath for direct implantation of the valve in the RVOT [19].
Valve-in-valve — PPVI can also be performed as a repeat intervention after failure of the primary device in the RVOT [20]. The indications and the implantation technique are the same for repeat PPVI as for primary PPVI. Valve-in-valve technology has also been used in other prosthetic valve sites [21].
OUTCOMES — Short- and medium-term results of PPVI with the Melody and SAPIEN valves are similar, though more data are available for the Melody valve. Long-term data are available for the Melody valve, as discussed below. Long-term data are not yet available for the SAPIEN valve.
Melody valve — Data are available from four short- and medium-term observational studies with a total of over 450 patients with one- to five-year follow-up [7,8,22,23] as well as from longer-term studies. These studies excluded 4 to 8 percent of the patients planned for PPVI due to an unfavorable right ventricular outflow tract (RVOT) dimension or coronary artery compression.
After successful PPVI, the following findings were noted:
●Overall mortality was 0 to 5 percent and was, as far as could be assessed, not related to the PPVI.
●The device was unstable in 1 percent, a conduit rupture requiring surgery occurred in 0.8 to 2 percent, compression of the left main coronary artery after device deployment occurred in 0 to 1 percent, and obstruction of the origin of one of the pulmonary branch arteries ("jailing") in 0.6 percent.
●The gradient over the RVOT fell significantly from median values of 35 to 40 to 10 to 20 mmHg. Pulmonary regurgitation decreased from median values of 16 to 27 percent to 1 to 2 percent. Median peak velocity over the RVOT was 1.9 to 2.7 m/s at one-year echocardiographic follow-up.
●Freedom from Melody valve dysfunction or reintervention was 94 to 95 percent at one year. Patients not requiring reintervention had mild or less pulmonic valve regurgitation at one-year follow-up. Overall, surgery was required in 3 percent during follow-up with freedom from reoperation of 86 percent at 30 months.
●Endocarditis was diagnosed in 1 to 3 percent of the cases up to five years after PPVI with Melody valves. (See 'Endocarditis' below.)
●At six months, New York Heart Association (NYHA) class improved in 77 percent of the patients and worsened only in 0.8 percent. RV end-diastolic volume and RV mass decreased significantly as demonstrated by cardiovascular magnetic resonance imaging.
●Stent fractures occurred in 20 to 21 percent in a series without pre-stenting and in 5 to 16 percent in a series with pre-stenting.
●In an early study, the first 50 patients of the series and those with residual gradients >25 mmHg had a higher risk of reoperations compared with the rest of the study group [22].
Four long-term studies on PPVI with the Melody valve have been published [24-27]. The best long-term results (estimated event-free survival rate of 88 percent at 10 years) were observed among patients with a RVOT residual peak invasive gradient of <15 mmHg after the intervention. One study compared the long-term outcome of PPVI (Melody valve) with surgical bioprosthetic pulmonary valve replacement [28]. At 10 years’ follow-up, there was no difference in freedom from valve replacement between the groups.
Some data suggest that PPVI in patients with postoperative right ventricular outflow obstruction or pulmonic regurgitation and concomitant moderate to severe tricuspid regurgitation results in acute reduction in the severity of tricuspid regurgitation and improvement in right ventricular remodeling [29,30]. More data are needed on the impact of PPVI on tricuspid regurgitation.
SAPIEN valve — Comparison studies with conventional surgery are lacking. Data are available from two short- and medium-term observational studies with a total of 43 patients [15,16]. In the larger series of 36 patients, successful valve deployment was achieved in 33 of 34 attempts [16]. Pullback peak-to-peak systolic gradient across the conduit decreased from 27 to 12 mmHg. At six months’ follow-up, the number of patients in NYHA functional class I increased from 5 at baseline to 27. Pulmonic regurgitation was moderate or less in 97 percent of patients. One patient was treated with a second valve due to conduit-induced distortion of the initial implant.
In the COMPASSION study, a total of 69 patients (SAPIEN THV 23 [n = 22], SAPIEN THV 26 [n = 47]) were successfully and effectively treated, and at three years’ follow-up, 90 percent of the patients had only mild or less pulmonary regurgitation [31]. Freedom from reintervention was 94 percent, and freedom from infective endocarditis was 97 percent. Additionally, two studies reported off-label PPVI with the SAPIEN S3 valve with short follow-up [32,33].
COMPLICATIONS
Coronary artery compression — Compression of the left main coronary artery after device deployment occurs in approximately 0 to 1 percent of all cases of PPVI and nearly always has a fatal outcome [7,8,22,23]. Therefore, a balloon test to exclude potential coronary artery compression should always be performed prior to deployment of the valve [10]. A balloon test positive for coronary artery compression was initially identified in approximately 1 percent of cases referred to PPVI [22]. A later study found coronary compression during the balloon test in 5 percent of the patients [34]. The intervention was abandoned in these cases. (See 'Balloon test' above.)
Rarely, hematoma formation from conduit laceration may cause acute extrinsic coronary artery compression [35].
Conduit rupture — Contained conduit rupture may easily be treated with covered stent implantation. Noncontained conduit rupture is an emergency. If not controlled by covered stent implantation, emergency surgery may be necessary (less than 1 percent of patients after PPVI) [7,8,22]. Risk factors for conduit rupture include heavy calcification of the conduit and a right ventricular outflow tract (RVOT) homograft valve [36].
Stent fracture — Risk factors for stent fracture include PPVI without pre-stenting (particularly with the Melody valve), severely obstructed conduits, PPVI into a native outflow tract, and presence of PPV recoil during balloon deflation [37,38].
Stent fractures (image 4) occur in 20 to 21 percent with the Melody valve without pre-stenting [8,22] and in 5 to 16 percent with pre-stenting [7,23]. In the majority of cases, these stent fractures have no significant hemodynamic effect [38]. However, stent fractures may ultimately lead to embolization of stent parts or restenosis [22]. Observational data suggest that pre-stenting reduces the risk of stent fractures [17,37]. Therefore, pre-stenting of the conduit with a bare metal stent before PPVI is now standard practice in most centers. (See 'Pre-stenting' above.)
So far, stent fractures have not been reported after PPVI with the SAPIEN valve. However, in the COMPASSION study, 91 percent of the patients were pre-stented preceding SAPIEN implantation [31]. SAPIEN PPVI without pre-stenting has been performed, as illustrated by a report of 57 patients with no stent fracture observed with median 5.7 months follow-up [39]. The rationale for this approach is that the stent of the SAPIEN valve is stronger than the stent of the Melody valve and thus may be less prone to stent fracture.
Endocarditis — All bioprosthetic valves predispose the patient to infective endocarditis (IE). IE after PPVI has been observed in approximately 1 to 3 percent of patients during one- to four-year follow-up [7,8,22,23,40-43]. The largest investigation of IE following PPVI with the Melody valve included 311 patients pooled from three prospectively identified cohorts and followed for a median of 2.5 years [41]. The data were updated to a median follow-up of 5.1 years. The annualized incidence rate of IE was 3.1 percent per patient year, and the transcatheter pulmonary valve-related IE rate was 2.4 percent. At five years post-PPVI, freedom from IE was 89 percent. By multivariate analysis, age ≤12 years at implant and immediate post-implant gradient ≥15 mmHg were associated with development of IE [44].
The rate of IE after PPVI is similar to the generally observed rate of IE after surgical RVOT reconstruction, which ranges from approximately 0 to 5 percent of patients during one- to four-year follow-up [45-52]. However, the rate of IE after PPVI may be higher than that seen after RVOT reconstruction with a homograft. A retrospective study included 677 patients with 738 right ventricular outflow conduits implanted between 1989 and 2013 [53]. Kaplan-Meier survival free of IE for patients with surgically implanted homografts was 98.7 percent at five years and 97.3 percent at 10 years; for surgically implanted Contegra conduits, it was 87.8 percent at five years and 77.3 percent at 10 years; and for transcatheter Melody valves, it was 84.9 percent at five years. Thus, the Contegra conduit and Melody valved stents (both produced from bovine jugular vein) were associated with significantly higher incidence of IE than homografts. However, it should be noted that a Melody valve is often implanted in a stenotic homograft. Therefore, it may be that a relevant number of Melody valves were implanted in a homograft that already suffered from clinically silent IE. Thus, further studies are needed to clarify these important observations.
A single-center series reported a significantly higher rate of IE after PPVI with the Melody valve compared with the SAPIEN valve. At a median of 1.8-year follow-up, there were eight cases of IE among 32 (5.7 percent) patients who received a Melody valve and no cases of IE among 47 patients with a SAPIEN valve [54]. Since long-term data for the SAPIEN valve are not available, additional data are needed to confirm whether IE rates differ among valve types. In these comparisons, not only valve type but also indication for treatment (stenosis or regurgitation) needs to be included.
Vegetations on a transcatheter pulmonic valve or conduit can be difficult to visualize by echocardiography [41,55]. A report suggested that intracardiac echocardiography can be helpful when transthoracic and transesophageal echocardiography fail to show vegetations [42]. Alternate imaging with cardiac computed tomography, magnetic resonance imaging, or positron emission tomography may also be helpful.
All patients with prosthetic valves, including those who have undergone PPVI are considered among those at highest risk for IE and therefore prophylaxis for bacterial endocarditis is suggested for high risk procedures such as all dental procedures that involve manipulation of gingival tissue, the periapical region of teeth, or perforation of the oral mucosa. Recommendations for antibiotic prophylaxis for endocarditis are discussed in detail separately. (See "Antimicrobial prophylaxis for the prevention of bacterial endocarditis".)
Investigational approaches — Three self-expanding valves are currently being evaluated for approval. The Harmony transcatheter pulmonary valve, the venous P valve, and the Pulsta valve may enable treatment of patients with larger RVOTs [56-58].
Another approach is the implantation of an adaptive pre-stent to create a landing zone for secondary PPVI with the SAPIEN valve [59].
SOCIETY GUIDELINE LINKS — Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: Cardiac valve disease".)
SUMMARY AND RECOMMENDATIONS
●Percutaneous pulmonic valve implantation (PPVI) is an effective treatment for selected patients with right ventricular outflow tract (RVOT) conduit (or native) stenosis or regurgitation. Short- and mid-term results are satisfactory, long-term results are only available for the Melody valve, and direct comparison with conventional surgery is not yet available. (See 'Outcomes' above.)
●We recommend PPVI in selected patients with severe RVOT obstruction or severe pulmonary regurgitation. (See 'Our approach' above.)
●The most common complication following PPVI is stent fracture which usually is hemodynamically benign. Uncommon complications occurring in 2 percent or less of patients include clinically significant conduit rupture, coronary artery compression, and endocarditis. (See 'Complications' above.)
●Since coronary compression is a life-threatening complication of PPVI, a balloon test is performed in the RVOT to exclude potential coronary artery compression (image 1). (See 'Implantation technique' above and 'Coronary artery compression' above.)
●Melody valve stents seem to be associated with higher incidence of infective endocarditis than homografts, and vegetations may be challenging to visualize by transthoracic and transesophageal echocardiography. (See 'Endocarditis' above.)
ACKNOWLEDGMENT — The UpToDate editorial staff would like to thank Sohrab Fratz, MD, PhD, who contributed to earlier versions of this topic review.
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