Author + information
- Received December 6, 2010
- Accepted January 4, 2011
- Published online July 5, 2011.
- Philip A. Roberts, MBChB⁎,†,⁎ (, )
- Younes Boudjemline, MD, PhD‡,
- John P. Cheatham, MD§,
- Andreas Eicken, MD, PhD∥,
- Peter Ewert, MD¶,
- Doff B. McElhinney, MD⁎⁎,
- Sharon L. Hill, MSN, ACNP, PhD§,
- Felix Berger, MD, PhD¶,
- Danyal Khan, MD††,
- Dietmar Schranz, MD#,
- John Hess, MD, PhD∥,
- Michael D. Ezekowitz, MBChB, DPhil‡‡,
- David Celermajer, MBBS, PhD⁎,† and
- Evan Zahn, MD††
- ↵⁎Reprint requests and correspondence:
Dr. Philip A. Roberts, Heart Centre for Children, the Children's Hospital at Westmead, Westmead, Sydney NSW 2145, Australia
Objectives This study sought to describe the first human series of percutaneous tricuspid valve replacements in patients with congenital or acquired tricuspid valve (TV) disease.
Background Percutaneous transcatheter heart valve replacement of the ventriculoarterial (aortic, pulmonary) valves is established. Although there are isolated reports of transcatheter atrioventricular heart valve replacement (hybrid and percutaneous), this procedure has been less frequently described; we are aware of no series describing this procedure for TV disease.
Methods We approached institutions with significant experience with the Melody percutaneous pulmonary valve (Medtronic, Inc., Minneapolis, Minnesota) to collect data where this valve had been implanted in the tricuspid position. Clinical and procedural data were gathered for 15 patients. Indications for intervention included severe hemodynamic compromise and perceived high surgical risk; all had prior TV surgery and significant stenosis and/or regurgitation of a bioprosthetic TV or a right atrium–to–right ventricle conduit.
Results Procedural success was achieved in all 15 patients. In patients with predominantly stenosis, mean tricuspid gradient was reduced from 12.9 to 3.9 mm Hg (p < 0.01). In all patients, tricuspid regurgitation was reduced to mild or none. New York Heart Association functional class improved in 12 patients. The only major procedural complication was of third-degree heart block requiring pacemaker insertion in 1 patient. One patient developed endocarditis 2 months after implant, and 1 patient with pre-procedural multiorgan failure did not improve and died 20 days after the procedure. The remaining patients have well-functioning Melody valves in the TV position a median of 4 months after implantation.
Conclusions In selected cases, patients with prior TV surgery may be candidates for percutaneous TV replacement.
Primary tricuspid valve (TV) disease is a rare entity, the etiology of which can be either congenital (e.g., Ebstein's anomaly or primary TV dysplasia) or acquired (e.g., rheumatic, endocarditis, or carcinoid disease). Tricuspid valve replacement (TVR), therefore, is not a common operation and, in most series, is associated with high post-operative mortality, despite advances in perioperative care (1–4). There continues to be debate in the surgical literature regarding whether bioprosthetic or mechanical valves are preferable in the TV position, with many centers preferring bioprosthetic valves due to the high failure rates and the anticoagulation and thrombotic complications associated with mechanical valves in this setting (3,5,6). Although bioprosthetic valves appear to have improved performance early after surgery, these valves will inevitably experience wear and degeneration, requiring a second implant.
It has been 10 years since the first successful percutaneous valve implantation was described (7), and in the past decade, a large amount of experience has been gained with transcatheter valve replacement for the aortic and pulmonary valves (8,9). In contrast, there has been very limited experience regarding the feasibility of percutaneous valve implantation in the tricuspid position.
This report describes the combined experience of 8 centers with implantation of the Melody transcatheter pulmonary valve (Medtronic, Inc., Minneapolis, Minnesota) both in the orthotopic tricuspid position and right atrium (RA) to right ventricle (RV) conduit.
A data sheet was circulated to all centers known to have requested the use of the Melody valve on a “special request” basis with institutional review board approval as applicable for use in the TV position. For each case identified, the following data were collected: age, weight, sex, diagnosis, previous surgical procedures, indication for TV surgery, number of previous TV procedures, details of surgically placed bioprosthesis, pre- and post-echocardiographic data, procedure date, percutaneous route, size of delivery system used, procedure and screening times, complications, medication pre- and post-procedure, and duration of follow-up. Statistics were carried out using SPSS software (version 17.0, IBM, Armonk, New York). p values for gradient reduction were calculated using the paired t test.
Prior to each procedure, a careful evaluation of the inner dimension of the tricuspid bioprosthesis or RA-RV conduit was made to assess for the presence of a suitable anchor point and to ensure that adequate expansion of the Melody valve would be achievable. Standard venous vascular access techniques were used for right heart catheterization. All procedures were performed under general anesthesia using fluoroscopy with or without echocardiographic guidance.
A total of 15 patients were identified from 8 centers. The primary indication for the procedure was predominantly stenosis in 10 (mean gradient >5 mm Hg) and predominantly regurgitation in 5 (moderate to severe tricuspid regurgitation and mean gradient 5 mm Hg or less). As expected, a mixed pattern of both stenosis and regurgitation was frequently present. Demographic data and diagnoses are shown in Table 1 with procedural details in Table 2. Mean and median ages were 33 and 31.5 years (range 8 to 64 years) and mean and median weight 69 kg (range 29 to 110 kg). All patients were symptomatic with pre-procedure New York Heart Association (NYHA) functional class graded as IV in 1 patient, class III in 10 patients, and class II in 3 patients (Fig. 1). The ventilated patient with multisystem organ failure was excluded from the NYHA functional classification. Five procedures involved Melody valve implantation into a dysfunctional RA-RV conduit in the setting of a functionally single-ventricle Fontan palliation, and 10 involved implantation into a dysfunctional bioprosthetic valve located in the orthotopic TV position (Table 2). Valve delivery and deployment were performed via the femoral vein in 11 and the internal jugular vein in 4 patients. Pre-dilation or low-pressure balloon sizing was utilized in 4 patients prior to valve delivery. A 22-mm Ensemble delivery system (Medtronic Inc.) was used in all patients except 1, where a 24-mm BIB balloon (Numed, Hopington, New York) was used due to the large diameter of the previously placed surgical valve and concern regarding achieving adequate apposition of the Melody valve. Post-implantation dilation of the Melody valve using higher pressure valvuloplasty balloons was performed in 7 patients. Average procedure and screening times were 120 ± 64 min (range 54 to 251 min) and 29 ± 18 min (range 8.3 to 74 min), respectively. In 1 patient (Case #15), a Melody valve was implanted in both the tricuspid and pulmonary valve positions at the same procedure. Figures 2 to 4⇓⇓ show pre- and post-echocardiographic and fluoroscopic images, and Figure 5 shows balloon interrogation of a bioprosthesis.
In those patients being treated primarily for stenosis, the median valve gradient was reduced from 12.5 to 3.5 mm Hg (mean 12.9 to 3.9 mm Hg) (p < 0.01). The median post-procedure TV gradient for all patients was 2 mm Hg (mean 2.9 mm Hg, range 0 to 7 mm Hg) (p ≤ 0.01). No patient had more than mild tricuspid regurgitation at the completion of the procedure, with 10 having no regurgitation as judged by echocardiography. One patient, in whom the valve was implanted with a 24-mm balloon, developed early progressive (from mild to moderate) tricuspid regurgitation. This patient, who was comatose with multisystem organ failure prior to Melody implantation, experienced initial improvement with a reduction in mean valve gradient from 14 to 6 mm Hg associated with a transient improvement in mental state, but ultimately died 2 days after surgical removal and replacement of the valve, 20 days after the initial implant.
Other complications included 1 case of third-degree heart block necessitating pacemaker implantation and 1 case of Melody valve endocarditis requiring valve removal 2 months post-implant (Fig. 6).
At latest follow-up (mean 9 months, and median of 4 months, range 0 to 38 months), 14 of 15 patients who underwent the procedure are alive and well with 13 of 14 retaining the Melody valve in the TV position. NYHA functional class improved acutely in all but 2 of the surviving patients (Fig. 1).
Major advances in the surgical management of congenital and acquired right-sided valvular heart disease have allowed the survival of increasing numbers of affected patients with congenital or acquired disease. The right side of the heart provides its own special set of anatomical and functional considerations, often necessitating the use of a bioprosthetic valve or valved conduit, all of which have a variable but limited longevity.
A considerable body of literature supports the use of the Melody valve in a stenotic and/or regurgitant RV to pulmonary artery conduit with particular morphologic features (8). An even greater number of percutaneous aortic valve replacements have been performed worldwide (9). Following development of transcatheter heart valve replacement in the ventriculoarterial valve position for high-risk surgical patients, the natural extension was to look for options for nonsurgical treatment of the stenotic and/or regurgitant RA-RV connection in patients considered high surgical risk. Transcatheter heart valve use has been reported in a prosthetic RA to RV conduit (Bjork-type connection in a complex univentricular-type heart) (10), and preliminary animal work has reported percutaneous TVR in the native valve annulus (11). Webb et al. (12) recently reported implantation of an Edwards Sapien valve (Edwards Lifesciences, Irvine, California) in a patient with a TV bioprosthesis using a hybrid approach with transcatheter delivery of the valve through thoracotomy access. There is a case report of a percutaneous valve placed inside a bioprosthetic valve for tricuspid stenosis (13); this patient is included in the current series (Case #6 in Tables 1 and 2).
We now report a series of 15 percutaneous TVRs using a bioprosthetic valve placed inside a previously implanted bioprosthetic valve or valved conduit, with important hemodynamic compromise. This series shows that percutaneous TVR is achievable with a high procedural success rate, when undertaken by groups experienced with transcatheter pulmonary valve implantation in carefully selected patients. This procedure may potentially reduce the total number of open cardiac bypass surgical procedures that a patient may have to undergo during their lifetime and does not appear to preclude or jeopardize the future use of a surgical approach should it be required. The advent of newer, larger devices that could be expanded beyond the current 22-mm upper limit of the Melody valve may further enhance the opportunities for percutaneous TV treatment.
There were some important complications observed. Proximity to the conduction system means that there is a risk of heart block, and this was observed in 1 case, requiring pacemaker insertion. There are some data indicating a risk of medium-term endocarditis with the Melody valve (14), and this was indeed observed in 1 of our patients. One patient died, although we note that this patient had been critically ill prior to the procedure and died soon after surgical replacement of the TV, highlighting the risk of surgery in this group of patients. Melody valve competence has been tested and recommended up to a diameter of 22 mm. Using a 24-mm BIB to deliver the Melody may explain why this patient had developed moderate tricuspid regurgitation post-procedure.
There are limitations to this study. Data were collected retrospectively from centers experienced with percutaneous pulmonary valve implantation, and thus the results presented may not be generally applicable. Furthermore, reporting as well as selection bias may be possible, although the participating centers did enter all of their relevant patients in this series. On the other hand, the procedure was generally attempted only in very high-risk patients, which may have influenced adversely the number of complications seen. Finally, this is an early and preliminary report of a novel procedure (median follow-up was only 4 months, range: 0 to 38 monts), which was done “off label” for humanitarian reasons; longer-term follow-up is clearly required to better understand the results beyond the short term, including valve function in the tricuspid position in relation to RV loading, RV systolic and end-diastolic pressure, ejection fraction, potential for stent fracture, arrhythmia, and exercise capacity.
In selected cases, with a suitable anchor point in a surgically placed but now dysfunctional bioprosthetic connection between the RA and RV, successful relief of stenosis and/or regurgitation can be achieved via the percutaneous placement of a stented bioprosthetic valve delivered via the percutaneous transvenous route.
The authors thank Andrew Cole and Victoria Pye for their help with preparation of the manuscript.
Drs. Roberts, Cheatham, Eicken, Ewert, McElhinney, Berger, Hess, and Zahn are proctors and/or consultants for Medtronic, Inc. The other authors have reported that they have no relationships to disclose.
- Abbreviations and Acronyms
- New York Heart Association
- right atrium
- right ventricle
- tricuspid valve
- tricuspid valve replacement
- Received December 6, 2010.
- Accepted January 4, 2011.
- American College of Cardiology Foundation
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