Author + information
- Received March 22, 2018
- Revision received May 30, 2018
- Accepted June 4, 2018
- Published online October 1, 2018.
- Damien Kenny, MD, MPHa,∗ (, )
- John F. Rhodes, MDb,c,
- Gregory A. Fleming, MDc,
- Saibal Kar, MDd,
- Evan M. Zahn, MDd,
- Julie Vincent, MDe,
- Girish S. Shirali, MBBSf,
- Jeremy Gorelick, PhDg,
- Mark A. Fogel, MDh,
- John T. Fahey, MDi,
- Dennis W. Kim, MD, PhDj,
- Vasilis C. Babaliaros, MDk,
- Aimee K. Armstrong, MDl and
- Ziyad M. Hijazi, MD, MPHm
- aOur Lady’s Children’s Hospital, Dublin, Ireland
- bMiami Children’s Health System, Miami, Florida
- cDuke University School of Medicine, Durham, North Carolina
- dCedars-Sinai Medical Center, Los Angeles, California
- eMorgan Stanley Children’s Hospital, New York, New York
- fChildren’s Mercy, Kansas City, Missouri
- gEdwards Lifesciences, Irvine, California
- hChildren’s Hospital of Philadelphia, Philadelphia, Pennsylvania
- iYale New Haven Hospital, New Haven, Connecticut
- jChildren’s Healthcare of Atlanta, Atlanta, Georgia
- kEmory University School of Medicine, Atlanta, Georgia
- lNationwide Children’s Hospital, Columbus, Ohio
- mSidra Cardiovascular Center of Excellence, Weill Cornell Medical College, Doha, Qatar
- ↵∗Address for correspondence:
Prof. Damien Kenny, Our Lady’s Children’s Hospital, Cooley Road, Crumlin, Dublin 12, Ireland.
Objectives This study provides the 3-year follow-up results of the COMPASSION (Congenital Multicenter Trial of Pulmonic Valve Regurgitation Studying the SAPIEN Transcatheter Heart Valve) trial. Patients with moderate to severe pulmonary regurgitation and/or right ventricular outflow tract conduit obstruction were implanted with the SAPIEN transcatheter heart valve (THV).
Background Early safety and efficacy of the Edwards SAPIEN THV in the pulmonary position have been established through a multicenter clinical trial.
Methods Eligible patients were included if body weight was >35 kg and in situ conduit diameter was ≥16 and ≤24 mm. Adverse events were adjudicated by an independent clinical events committee. Three-year clinical and echocardiographic outcomes were evaluated in these patients.
Results Fifty-seven of the 63 eligible patients were accounted for at the 3-year follow-up visit from a total of 69 implantations in 81 enrolled patients. THV implantation was indicated for pulmonary stenosis (7.6%), regurgitation (12.7%), or both (79.7%). Twenty-two patients (27.8%) underwent implantation of 26-mm valves, and 47 patients received 23-mm valves. Functional improvement in New York Heart Association functional class was observed in 93.5% of patients. Mean peak conduit gradient decreased from 37.5 ± 25.4 to 17.8 ± 12.4 mm Hg (p < 0.001), and mean right ventricular systolic pressure decreased from 59.6 ± 17.7 to 42.9 ± 13.4 mm Hg (p < 0.001). Pulmonary regurgitation was mild or less in 91.1% of patients. Freedom from all-cause mortality at 3 years was 98.4%. Freedom from reintervention was 93.7% and from endocarditis was 97.1% at 3 years. There were no observed stent fractures.
Conclusions Transcatheter pulmonary valve replacement using the Edwards SAPIEN THV demonstrates excellent valve function and clinical outcomes at 3-year follow-up.
Transcatheter pulmonary valve replacement (TPVR) is widely accepted as a viable alternative to surgery for dysfunctional right ventricle–to–pulmonary artery (RV-PA) conduits. Clinical trials have been conducted evaluating the short-term outcomes with 2 commercially available balloon-expandable valve systems: SAPIEN (Edwards Lifesciences, Irvine, California) and Melody (Medtronic, Minneapolis, Minnesota), both demonstrating good procedural success, low major complication rates, and good early and medium-term valve function (1,2). To date, there has been more extensive clinical experience with the Melody valve in patients undergoing TPVR. Studies from multiple international sites have demonstrated low serious complication rates (3–5) and have confirmed good valve durability (6). There are, however, evolving concerns over the relatively high rates of frame fractures and endocarditis and the size limitations of the valve (7–10). Extensive clinical experience exists with the SAPIEN transcatheter heart valve (THV) in the transcatheter aortic valve replacement (TAVR) setting, but not in the early phase I clinical trial setting (11,12). However, such experience with the SAPIEN THV in the pulmonary position has been previously reported, although retrospectively (13–16).
The prospective, nonrandomized, multicenter COMPASSION (Congenital Multicenter Trial of Pulmonic Valve Regurgitation Studying the SAPIEN Interventional THV) investigational device exemption study was designed to assess the safety and efficacy of the SAPIEN THV for the treatment of dysfunctional right ventricular - outflow tract (RVOT) conduits with moderate to severe pulmonary regurgitation and/or obstruction. Here, we report the observed up to 3-year outcomes of the COMPASSION clinical trial with particular emphasis on valve function and freedom from reintervention.
Patients and study protocol
Between April 2008 and November 2014, 81 patients from 7 centers in the United States were enrolled in the prospective, multicenter investigational device exemption trial sponsored by Edwards Lifesciences. The study was conducted under investigational device exemption G060242 and was registered at ClinicalTrials.gov (NCT00676689). The U.S. Food and Drug Administration and the Institutional Review Boards of all participating centers approved the protocol prior to patient enrollment (Table 1).
Patients with dysfunctional RV-PA conduits, defined as ≥3+ pulmonary regurgitation by transthoracic echocardiography (TTE) or pulmonary regurgitant fraction ≥40% by cardiac magnetic resonance imaging (MRI) and/or RVOT conduit obstruction (mean gradient ≥35 mm Hg) by TTE were considered eligible for inclusion in the trial provided that body weight was ≥35 kg and in situ conduit diameter was ≥16 and ≤24 mm.
Important exclusion criteria included RVOT aneurysm, previous angiographic evidence of coronary artery (CA) compression, need for concomitant interventional procedures such as atrial septal defect or ventricular septal defect closure, obstruction of the central veins preventing advancement of the pulmonic bioprosthesis delivery system to the heart, and a history of endocarditis or active endocarditis. A complete listing of exclusion criteria is available in Table 2.
Informed consent was obtained from all potential subjects and/or their legal guardians prior to any study procedures being performed. Pre-procedural baseline assessment included standard laboratory testing and standardized protocols for echocardiography, exercise testing, computed tomography (CT) and MRI.
Patients were considered enrolled in the study after it had been determined that they met all of the inclusion and none of the exclusion criteria and provided written informed consent. The as-treated population was defined as all subjects who had the study valve implanted in the target location.
Valve system and procedural details
The specifics of the valve and valve delivery system and the intraprocedural protocol were described in detail in a previous clinical report (1). Briefly, transvenous access enables delivery of the SAPIEN THV (valve size of 23 or 26 mm) using the Retroflex delivery system.
Primary and secondary outcomes
The primary outcome for the trial was freedom from device- or procedure-related death and/or reintervention at 1 year. In addition, device success was measured and defined as deployment of the valve to the target area and removal of the delivery catheter from the body with improvement in pulmonary regurgitation to mild or less (≤2+) per the earliest evaluable echocardiogram.
Secondary outcomes included freedom from major adverse cardiovascular and cerebrovascular events (MACCE) and functional improvement; both were assessed at 6 months. MACCE included death, myocardial infarction, reoperation, vascular injury resulting in the need for an unplanned vascular intervention, stroke, and pulmonary embolism. Functional improvement was assessed by improvement in degree of pulmonary regurgitation and stenosis using TTE, pulmonary regurgitation on MRI, symptoms assessed by New York Heart Association (NYHA) functional classification, and exercise tolerance as assessed by cardiopulmonary exercise testing using a ramp work load protocol. Anaerobic threshold was determined by use of the modified V-slope method. All study echocardiograms, MRI examinations, and exercise stress tests were interpreted in centralized (core) facilities.
Following discharge from the hospital, an office visit for clinical follow-up was scheduled at 30 ± 7 days, 6 months ± 14 days, 12 months ± 30 days, and annually thereafter (±45 days) post-procedure. Outcome variables were recorded, and serial investigations were performed as previously outlined (1). Standardized protocols for TTE, CT, chest radiography (CXR), MRI, and exercise testing were implemented. Pulmonic regurgitation, right ventricular pressure, peak velocity across the implanted valve, pulmonic regurgitation jet velocity, pulmonic valve conduit mean gradient, and tricuspid valve peak and mean gradients were also evaluated at each visit on TTE and evaluated independently through the respective core laboratory. Stent fractures were evaluated on CXR by the core laboratory as well as an independent safety team at baseline, post-procedure, discharge, 30 days, 6 months, 1 year, and annually up to 5 years post-procedure.
All adverse events were carefully documented on the case report forms and were adjudicated by an independent clinical events committee. Time to reintervention was calculated as the time from implantation to reintervention or last follow-up. Follow-up CT was included to evaluate for pulmonary embolism. Serial CXR was performed to evaluate for valve frame fractures.
Baseline data were summarized for the enrolled patients. Summaries of data at follow-up were based on the cohort of patients who had the study valve implanted. Unless otherwise noted, the mean ± SD were calculated for continuous variables; the percentage of patients in each category were reported for categorical variables. Time to event data (death, reintervention, MACCE, and fracture) were calculated as the time from implantation to the event of interest or last follow-up. Freedom from the event was calculated using the Kaplan-Meier method. NYHA functional class and echocardiographic data were summarized at baseline, 30 days, 6 months, and 1 year. Kaplan-Meier rates are provided through 1 year. The Wilcoxon signed rank test was used to compare paravalvular regurgitation and NYHA functional class at baseline with each follow-up visit at α = 0.05. All statistical analysis was performed using SAS version 9.3 (SAS Institute, Cary, North Carolina).
Baseline and demographic characteristics
A summary of baseline, demographic, and clinical risk data is presented in Table 3. The median age of the valve-implanted cohort was 27.0 years (interquartile range: 18.0 to 34.0 years), with 26 patients (32.9%) <21 years or age and 65.8% of patients were men. The median weight of the valve-implanted cohort was 69.0 kg (interquartile range (IQR): 51.6 to 82.5 kg). The primary underlying diagnosis was tetralogy of Fallot in 42%, Ross procedure in 33%, and truncus arteriosus in 6%. The primary indications for THV implantation were pulmonary stenosis (7.6%), regurgitation (12.7%), and both (79.7%). At baseline, 73.3% of patients were diagnosed with moderate to severe pulmonic stenosis, whereas 26.7% of patients were in NYHA functional class III or IV. Of the treated cohort, 95.1% of patients were diagnosed with moderate to severe regurgitation. It is important to note that 91% of the patients underwent pre-stenting prior to or during the procedure. A variety of pre-stents were used, including Palmaz XL and ev3 Mega and Max LD.
Of the 81 enrolled patients, the index procedure started in 79 patients, with 2 exceptions due to pre-procedural screening failures. Late screening failure was identified in 4 patients because of inappropriate conduit size (n = 2), bioprosthetic valve in another position (n = 1), and potential for left CA compression (n = 1). Another 5 patients did not undergo attempted valve implantation secondary to procedural technical issues unrelated to the actual valve. Therefore, SAPIEN THV implantation was attempted in 70 patients and was successful in 69 patients, as shown in Figure 1 and Table 3. Follow-up visits were not completed for 2 patients, 7 patients, and 6 patients, at 1, 2, and 3 years, respectively. To evaluate stent fractures, CXR was performed in 60, 53, and 39 patients, respectively, at 1, 2, and 3 years.
Twenty-two patients (27.8%) underwent implantation with 26-mm valves; the remainder received 23-mm valves. The median duration of the procedure was 165.0 min (IQR: 104.0 to 211.0 min), and the total fluoroscopy time was 38.5 min (IQR: 30.0 to 56.3 min). The median volume of contrast used was 192.0 ml (IQR: 137.0 to 275.0 ml). Pre-stenting and high-pressure balloon valvuloplasty were needed in 91.0% and 61.3%, respectively, in the treated cohort. Procedural complications were noted in 6 patients who did not receive or retain study devices, including conduit rupture during pre-stent implantation (n = 3), homograft dissection (n = 1), pre-stent migration (n = 1), and SAPIEN valve dislodgement (n = 1). The latter 2 patients required surgery for the removal of the stents.
Follow-up data through 3 years were available in 57 of 62 patients eligible for 3-year follow-up (91.9%) who received SAPIEN THVs.
In this study, the overall device success rate was 95.2%. At 3 years, no SAPIEN THV stent fractures were reported.
Freedom from all-cause mortality was 100% at 1 year, 98.4% at 2 years, and 3 years of follow-up. Freedom from reintervention was 97.1% at both 1 and 2 years and 93.7% at 3 years (Figure 2). Through 3 years of follow-up, there were 7 reinterventions in 4 patients. Three patients underwent pulmonary valve replacement of the implanted SAPIEN THV. Of the 3 patients, 1 received a surgical pulmonary valve replacement with a Medtronic Freestyle valve, and 2 patients underwent valve-in-valve procedures with SAPIEN THVs. One patient who underwent a valve-in-valve procedure developed severe pulmonic stenosis and had surgical pulmonary valve replacement performed on day 223 after the index procedure. The same patient underwent a second surgical pulmonary valve replacement on day 714 because of pulmonary valve regurgitation. The fourth patient underwent pulmonary balloon valvuloplasty without pulmonary valve replacement.
Freedom from MACCE at 3 years was 87.5%. Two early (<30 days) valve failures were reported, one with significant valve stenosis on the second post-procedural day and thought to be due to a stuck leaflet and the other with significant pulmonary regurgitation noted 28 days after valve implantation. Both patients underwent successful valve-in-valve implantation. These results are summarized in Table 4. Kaplan-Meier survival estimates were calculated at each time point and used the first event per patient. Freedom from all-cause mortality, myocardial infarction, and stroke at 3 years was 98.4%, 98.3%, and 100%, respectively. At 3 years, freedom from vascular injury was 98.6%, pulmonary embolism was at 98.5%, and freedom from endocarditis was 97.1%. The total follow-up time was 192 years for the valve implantation population, and the annualized rate of infective endocarditis was 1.04% per patient year. For transcatheter pulmonary valve–related infective endocarditis, the annualized rate was 0.5% per patient per year.
Reduction in the conduit mean gradient is shown in Figure 3. The conduit mean gradient changed from 21.2 ± 14.2 mm Hg at baseline to 10.2 ± 7.8 mm Hg at 3 years (p < 0.0001). The percentage of patients with moderate to severe pulmonary regurgitation decreased from 89.9% at baseline to 8.8% at 3 years, as shown in Figure 4.
Improvement in NYHA functional class is shown in Figure 5. The proportion of patients in class III or IV decreased from 31.9% at baseline to 1.8% at 3 years, with improvements in NYHA functional class reported in 93.5% of patients. Through 3 years of follow-up, no patient was classified in NYHA functional class IV, and 80.4% of patients were classified in NYHA functional class I.
The results of the COMPASSION trial at 3 years of follow-up substantiate the excellent clinical performance and efficacy with the SAPIEN THV in the pulmonary position. Unlike alternative balloon-expandable valves implanted in dysfunctional RV-PA conduits, there were no stent fractures reported in the COMPASSION trial as assessed by serial CXR. In the U.S. Melody valve trial, freedom from diagnosis of stent fracture was 77.8% at 14 months. It is noteworthy that in the U.S. Melody trial, pre-stenting was not permitted initially, and fracture rates may have reduced following the introduction of pre-stenting.
At 2 and 3 years, freedom from reintervention was 97.1% and 93.7%, respectively, which is higher than that reported for Melody transcatheter pulmonary valve at 87.6% at 2-year follow-up (2). In the COMPASSION study, intracardiac echocardiography and cardiac catheterization were used to understand the mechanism of valve failure. Patient #1 had 4 reinterventions: the first 2 reinterventions were on the day of the procedure, and the third and fourth reinterventions were 7 months and 2 years after the procedure, respectively. The first 2 reinterventions consisted of balloon valvuloplasty because of a stuck leaflet and a valve-in-valve implantation. The other 2 reinterventions involved surgical pulmonary valve replacements because of severe pulmonic stenosis and pulmonary valve regurgitation, respectively. In patient #2, a valve-in-valve procedure with a SAPIEN THV was successfully performed at 30-day follow-up because of a stuck leaflet. In patient #3, balloon valvuloplasty was done at the RVOT. In patient #4, significant stenosis of SAPIEN THV led to a surgical pulmonary valve replacement.
Up to 3 years, freedom from endocarditis was 97.1% in the COMPASSION trial, with 3 events occurring in 2 patients at days 25, 51, and 71 days post-procedure. One patient developed Staphylococcus epidermidis endocarditis 25 days following implantation and was treated with vancomycin, rifampin, and gentamicin. The second patient traveled to the Caribbean islands and was bitten by sand flies and infected by Cardiobacterium hominis. The patient subsequently developed endocarditis 71 days following implantation and was treated by administrating antibiotics. Unfortunately, the patient developed pulmonary emboli (possibly secondary to septic emboli from the pulmonary valve), but TTE and Doppler imaging showed that the SAPIEN THV remained in a good position, with no evidence of stenosis, regurgitation, vegetation, thrombus, or deep vein thrombosis.
Previously, a low rate of 1% of endocarditis was reported in the aortic SAPIEN TAVR cohort of the high-risk PARTNER (Placement of Aortic Transcatheter Valve) trial (12). Studies have suggested that implantation technique may influence rates of early endocarditis following transcatheter valve replacement and that greater vigilance with procedural sterility may reduce further rates of early endocarditis (17). Endocarditis rates between 2.7% and 7.5% have been reported with the Medtronic Melody valve, at 2 years (7–9). Even though a greater propensity for bacteria to adhere to the bovine jugular vein material used in the Melody valve leaflets has been previously shown, the etiology of endocarditis in TPVR remains unclear (10,18). However, higher endocarditis rates have also been noted with surgically implanted Contegra conduits, which are also derived from bovine jugular vein material (8,10).
Functionality and clinical improvement
Effective functionality and clinical improvement of the SAPIEN THV in the pulmonic position as demonstrated in the COMPASSION trial has been previously reported in other studies with smaller cohorts. Kenny et al. (1) first evaluated the safety and effectiveness of the Edwards SAPIEN THV in the pulmonary position in patients with moderate to severe pulmonary regurgitation with or without stenosis, at 6 months. The durability of the Edwards SAPIEN THV was evident when assessing valvular competence and the SAPIEN THV maintained effective pulmonary competence (≤2+) in 97% of patients. In yet another study, Wilson et al. (15) reported sustained gradient reduction and longer term valve competence in a cohort of 25 patients from a single center undergoing TPVR with the SAPIEN and SAPIEN XT THVs with a mean follow-up period of 3.5 ± 2.1 years. Wilson et al. concluded that the SAPIEN and SAPIEN XT valves in the pulmonic position are a viable and durable option with low valve failure rates during longer term follow-up, even in older patients. These reports are in contrast to previously reported surgical series of pulmonary valve replacement in which left ventricular filling was limited in older patients (19,20).
In the COMPASSION study, a reduction in conduit gradients was sustained, with 96.7% of patients demonstrating mild pulmonary regurgitation or less. Similar early reduction in RVOT gradients and restoration of pulmonary valve competence have been seen in a multicenter cohort of 21 patients, 4 of whom underwent valve implantation in a native patched RVOT (12). In addition, Kenny et al. (1) demonstrated a 91% reduction in severe pulmonary regurgitation from baseline to 6-month follow-up period.
Freedom from MACCE
Freedom from MACCE, including the need for reintervention, was 92.6% and 87.5% at 2- and 3-year follow-up. Freedom from Melody valve dysfunction or reintervention was 87.6% at 2 years (2). Early valve failure rates of up to 17% at 1 year have been reported with surgical homografts, with distortion of homograft angle within the RVOT resulting in the development of significant pulmonary regurgitation (21). The creation of rigid stented outflow in the setting of TPVR is likely to militate against valve failure secondary to angular distortion of the RVOT.
Previously, reintervention rates in patients with RV-PA conduits have been linked to the underexpansion of the SAPIEN THV (22), emphasizing the importance of pre-stenting, not necessarily to mitigate against stent fracture but to ensure an adequately expanded landing zone for the valve. Adherence to sizing recommendations with avoidance of “oversizing” may also help avoid this occurrence. Further iterations of the SAPIEN THV have evolved with a greater range of valve diameters available, which may also help avoid conduit-valve size mismatch (10). Valve thrombosis has been reported previously in the aortic position (23). Early restenosis secondary to thrombus formation has been reported rarely in patients undergoing TAVR with the SAPIEN THV. The patients have responded well to oral anticoagulation, with resolution of increased transcatheter Doppler gradients as assessed by echocardiography, if the valve thrombosis is identified and treated early (22). It is unclear if this phenomenon may also be seen in the pulmonary circulation, with lower velocity flows and the presence of pre-stent material being potentially exacerbating factors. However, the addition of follow-up CT to the COMPASSION study demonstrated pulmonary embolus in only 1 patient, secondary to endocarditis. Despite this extremely low incidence, thrombosis should be considered in the rare instance of early valve restenosis, as it may respond well to conservative measures (24).
In the present study, 13% of patients in whom the index procedure was initiated did not receive SAPIEN THVs, as shown in Figure 1. Nine of the patients were late screening failures. Four of the late screening failures (5%) were a consequence of conduit rupture. Small tears in subjects’ pulmonary homografts during the procedure or during balloon dilation accounted for the conduit ruptures, and none of these patients required surgery. Previously, conduit rupture has been reported at 6% in patients undergoing TPVR (25). Off-label use of the NuMED covered Cheatham-Platinum Stent provides a therapeutic solution in cases of conduit rupture or tear. As the Cheatham-Platinum Stent was still investigational at the time of the COMPASSION trial enrollment, its use required that patients exit from the COMPASSION trial (25).
Similar to this COMPASSION study, Kenny et al. (1) showed the absence of early incidence of valve migration with the SAPIEN THV following implementation of a more detailed protocol outlining slower valve deployment.
Risk for CA compression
Although TPVR is a realistic alternative to surgical pulmonary conduit replacement, the durability of stented valve systems in the RVOT has been a concern (22). In the COMPASSION trial, the freedom from valve fracture is 100%.
Sizing algorithms using multidetector CT or magnetic resonance angiography and more detailed analysis of the landing zone are currently being used. These analyses may result in less embolization, valve rupture, or other landing zone complications such as coronary compression (22). Morray et al. (26) demonstrated, in a multicenter study of >400 patients undergoing catheterization for intended TPV implantation, that about 5% of patients did not undergo valve placement because of a documented risk for CA compression. Three patients undergoing prior Rastelli procedure had left anterior descending CA compression, where the risk for coronary compression appears to be most pronounced. Patients with abnormal CA anatomy are more likely to be excluded because of risk for CA compression. In the COMPASSSION trial, no patients had CA compression.
This study reports a series of patients implanted with the original SAPIEN THV. Even though the SAPIEN family has evolved, the predominant modifications have been made to the valve frame design and delivery system, and therefore the performance of the leaflets still remains valid.
The SAPIEN THV demonstrates excellent sustained valve function at 1 year. Mortality and reintervention rates are low, with freedom from endocarditis of 97.1% at 1 year. There were no observed valve stent fractures. Data gleaned from COMPASSION and out to 5 years after valve implantation will continue to provide important follow-up data assessing the longer term functionality and clinical outcomes of the SAPIEN THV in the pulmonary position. It is accepted that newer SAPIEN valve iterations are currently available, but as yet clinical trial evaluation of the performance of these valves in the pulmonic position is awaited.
WHAT IS KNOWN? Longer term performance of the SAPIEN THV in the pulmonary position has yet to be determined.
WHAT IS NEW? The 3-year outcomes of the COMPASSION multicenter clinical trial with particular emphasis on valve function and freedom from mortality and reintervention are accounted for in this report. When implanted in patients with moderate to severe pulmonary regurgitation and/or RVOT conduit obstruction, the SAPIEN THV was associated with favorable outcomes at 3 years, with low rates of all-cause mortality, reintervention, and endocarditis and no stent fractures.
WHAT IS NEXT? The translation of these results with the next-generation balloon-expanding valves is needed to identify clinical characteristics and benefits for patients.
The authors thank Jaime Wheeler, Tenley Koepnick, and Prashanthi Vandrangi of Edwards Lifesciences for their assistance with the data collection and the report.
The trial was sponsored and funded by Edwards Lifesciences. Drs. Hijazi, Zahn, and Babaliaros are consultants to Edwards Lifesciences.
Dr. Shirali is a consultant to, recipient of research grants from, and member of the advisory board of Philips Medical Systems; and has received research grants from Edwards Lifesciences. Dr. Fogel has received grants from Edwards Lifesciences for the COMPASSION study. Dr. Gorelick was an employee of Edwards Lifesciences during the trial. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Abbreviations and Acronyms
- coronary artery
- computed tomography
- chest radiography
- major adverse cardiovascular and cerebrovascular event(s)
- magnetic resonance imaging
- New York Heart Association
- right ventricular outflow tract
- right ventricle–to–pulmonary artery
- transcatheter aortic valve replacement
- transcatheter heart valve
- transcatheter pulmonary valve replacement
- transthoracic echocardiography
- Received March 22, 2018.
- Revision received May 30, 2018.
- Accepted June 4, 2018.
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