Transcatheter valve implantation for degenerated tricuspid bioprosthesis and failed tricuspid ring
Introduction
Biological prostheses in the tricuspid position are at risk of degeneration, resulting in prosthesis failure, manifesting as tricuspid regurgitation (TR) or stenosis (TS). An accurate rate of tricuspid valve replacement (TVR) longevity is difficult to estimate because data available for ‘freedom from reoperation’ likely underestimates the true incidence of valve degeneration, since reoperation for isolated tricuspid valve (TV) disease is rare and carries a high degree of surgical risk (1). The reported bioprosthesis failure (TR or TS) rate necessitating re-operation is between 10% and 22% during a follow-up of five to nine years (2-6). These rates are even higher for patients with Ebstein’s anomaly, with a reoperation rate of 18–26% within ten years (2,7,8).
Surgical replacement of failing tricuspid prosthesis is among the highest risk operations classified in the Society of Thoracic Surgeons (STS) registry, particularly in the presence of right ventricular dysfunction (9). Thus, transcatheter tricuspid valve-in-valve (TViV) and valve-in-ring (TViR) implantation have become a viable therapy for a failed tricuspid bioprosthesis (10), due to the favorable safety profile and high success rate of TViV and TViR compared with redo tricuspid surgery (11). This is especially apparent in the setting of right ventricular dysfunction, which is frequently associated with a failed tricuspid prosthesis and inversely influences surgical outcomes (12-15).
Methods
Patients and data collection
The electronic databases of New York Presbyterian Columbia Medical Center were retrospectively reviewed for cases of transcatheter tricuspid valve replacement (TViV or TViR). From June 2012 to November 2019, data was retrospectively collected from ten consecutive patients treated with transcatheter tricuspid valve replacement. All procedures were performed at Columbia University Medical Center, New York, NY. Patient data was obtained through retrospective record review. Thirty-day events were acquired from the office visit record.
Endpoints
The primary safety endpoint was procedure-related adverse events, including clinically evident cardiac perforation, new pericardial effusion and sustained ventricular arrhythmia. The primary efficacy endpoint was defined as successful valve deployment with total (paravalvular or intravalvular) tricuspid regurgitation estimated as mild or less.
Statistical analysis
Results are depicted as median [interquartile range (IQR)] for numerical data and percentage for categorical data. Results are descriptive in nature.
Results
Demographic data
A total of ten patients with degenerated tricuspid bioprosthetic valve were included in this study. Baseline characteristics are presented in Tables 1,2 and Tables S1-S3. All patients had a significant comorbidity burden with median STS score of 9.5% (IQR 1.8, 19.3) and significant exertional limitations, with 70% of patients with greater than or equal to NYHA class 3 symptoms. Other heart failure symptoms were edema (70%), ascites (40%), and fatigue 70%). Of the ten patients, 40% presented with isolated TS, 20% with isolated TR, and 40% with mixed TS and TR.
Table 1
| Patient | Age | Sex | STS score | Years from initial TVR | Surgical prosthesis type (ring |
Surgical prosthesis brand | Surgical |
Mode of prosthesis |
Mean Gradient (mmHg) | iEOA |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 79 | M | 23 | 8 | Valve | Carpentier-Edwards | 25 | Severe TS | 6 | n/a |
| 2 | 58 | F | 8.9 | 4.7 | Valve | “Tissue” | 33 | Severe TR, Severe TS | 7 | 0.3 |
| 3 | 46 | F | 5.6 | 11.5 | Valve | Carpentier-Edwards | 31 | Severe TS, Moderate TR | 7 | 0.7 |
| 4 | 31 | M | 1.0 | 9.3 | Valve | Carpentier-Edwards | 33 | Severe TS, Moderate TR | 4 | 0.5 |
| 5 | 70 | F | 29.9 | 5.9 | Valve | Carpentier-Edwards | 33 | Severe TS | 6.3 | n/a |
| 6 | 28 | M | 1.8 | 5.2 | Valve | EPIC | 33 | Severe TR | 6.5 | n/a |
| 7 | 59 | M | 11.3 | 12.2 | Valve | Carpentier-Edwards | 33 | Severe TS | 14 | 0.3 |
| 8 | 75 | F | 19.3 | 11 | Valve | Mosaic | 33 | Severe TR, Severe TS | 7.7 | 0.2 |
| 9 | 62 | M | 10.1 | 19 | Valve | Carpentier-Edwards | 31 | Severe TS | 13.1 | 0.3 |
| 10 | 40 | F | 1.8 | 10.5 | Valve | Edwards 6900 | 33 | Severe TR | 2.5 | 0.9 |
TS, tricuspid stenosis; TR, tricuspid regurgitation; LEE, lower extremity edema; DOE, dyspnea on exertion; STS, Society of Thoracic Surgeons; TVR, tricuspid valve replacement; iEOA, index effective orifice area.
Table 2
| Patient | LE edema | Ascites (abdominal distention) | Fatigue | Pleural effusion | NYHA | LVEF* | LV size* | RVF* | RV size* | RVSP* | TR* (central/PVL) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | + | + | + | + | 4 | 60−65 | Normal | Preserved | Normal | n/a | None |
| 2 | − | − | + | − | 2 | 68 | Normal | Normal | Normal | n/a | Severe central |
| 3 | + | − | + | − | 2 | 60−65 | Normal | Normal | Normal | 38 | Moderate central |
| 4 | − | − | + | − | 2 | 55−60 | Small cavity | Moderately reduced | Severely increased | 27.6 | Moderate central |
| 5 | + | + | + | + | 4 | 55−60 | Small cavity | Preserved | Normal | 33 | Mild central |
| 6 | − | − | + | − | 4 | 10−15 | Small cavity | Severely reduced | Severely increased | n/a | Severe central |
| 7 | + | + | − | + | 4 | 67 | Normal | Moderately reduced | Moderately increased | 28 | Mild central |
| 8 | + | + | + | − | 3 | 55−60 | Mildly increased | Mild-moderately reduced | Normal | 37 | Severe central |
| 9 | + | − | − | − | 3 | 60−65 | Normal | Normal | Normal | n/a | Mild central |
| 10 | + | − | − | − | 3 | 71 | Normal | Moderately-severely reduced | Severely increased | 31 | Severe central |
LE, lower extremity; NYHA, New York Heart Association; LVEF, left ventricular ejection fraction; LV, left ventricle; RVF, right ventricular function; RV, right ventricle; RVSP, right ventricular systolic pressure; TR, tricuspid regurgitation.
Procedural outcomes
All patients were treated with the SAPIEN transcatheter heart valve (THV) (first generation, XT or Sapien 3; Table 3) (Edwards Lifesciences, Irinve, California, USA). The TViV procedure was successful in all patients, and no immediate post-replacement paravalvular leak (PVL) was reported in any patient. All patients tolerated the procedure well, and no intra-procedural complications were reported. No patient required treatment with inotropes or mechanical support after the procedure. Median length of hospitalization was 2.5 days (IQR 1, 6), and the majority of patients (90%) were treated with anticoagulation at discharge (of them, three patients were treated with anticoagulation on admission).
Table 3
| Patient | THV brand | THV Size | iEOA (immediate post) (cm2/m2) | PVL grade |
Mean gradient (mmHg) | Procedure |
Length of |
|---|---|---|---|---|---|---|---|
| 1 | Sapien | 26 | 1.4 | None | 2 | None | 4 |
| 2 | Sapien XT | 29 | 1.1 | None | 2 | None | 1 |
| 3 | Sapien XT | 29 | 1.7 | None | 1 | None | 1 |
| 4 | Sapien XT | 29 | 1.3 | None | 1 | None | 3 |
| 5 | Sapien 3 | 29 | 1.4 | None | 1 | None | 23 |
| 6 | Sapien 3 | 29 | n/a | None | 1.7 | None | 1 |
| 7 | Sapien 3 Ultra Valve | 29 | 1.2 | None | 2 | None | 29 |
| 8 | Sapien 3 | 29 | n/a | None | 4.8 | None | 6 |
| 9 | Sapien 3 | 29 | n/a | None | 4 | None | 2 |
| 10 | Sapien 3 Ultra Valve | 29 | 1.3 | None | 2 | None | 1 |
THV, transcatheter heart valve; iEOA, index effective orifice area; PVL, paravalvular leak.
Thirty-day outcomes
At thirty-days, all patients were alive and reported significant improvements in symptoms and functional status (Table 4). Edema improved in four patients (40%), ascites in three patients (30%) and follow-up echocardiography at a median of 1.3 months (IQR 0.7, 4.2) confirmed the absence of significant residual TR in all patients. Left ventricular (LV) function remained similar to baseline in all patients. Right ventricular (RV) function remained stable at thirty-days after the procedure in two patients, deteriorated in three patients and improved in one patient. Treatment with diuretics at thirty-days remained similar to baseline (pre-procedure).
Table 4
| Patient | LE Edema | Ascites (abdominal distention) | Fatigue | Pleural Effusion | NYHA | LVEF* | LV Size* | RVF* | RV size* | RVSP* | TR* (central/PVL) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | + | + | + | + | 3 | 55 | Normal | Mildly reduced | Mildly increased | n/a | None |
| 2 | − | − | − | − | 1 | 65 | Normal | n/a | n/a | n/a | None |
| 3 | − | − | − | − | “Exercise tolerance has definitely improved” | 60–65 | Normal | Normal | Normal | n/a | Trace central |
| 4 | − | − | − | − | “Improvement in stamina” | 60 | Mildly reduced | Severely reduced | Severely increased | 25 | Trace central |
| 5 | − | − | + | + | “Feeling better but still limited due to DOE” | n/a | n/a | n/a | n/a | n/a | n/a |
| 6 | − | − | − | − | “Symptoms of DOE have markedly improved” | 10–15 | Normal | Severely reduced | Severely increased | n/a | None |
| 7 | + | − | − | − | “DOE is much improved” | 65 (2 weeks post) | Normal | Severely reduced | Mildly increased | n/a | Trace PVL |
| 8 | − | − | − | − | 2 | 50–55 | Mildly increased | Borderline reduced | Normal | n/a | None |
| 9 | + | − | − | − | 2 | n/a | n/a | n/a | n/a | n/a | n/a |
| 10 | − | − | − | − | 2 | n/a | n/a | n/a | n/a | n/a | n/a |
*, Follow-up echocardiography was performed from 12 days to 7 months. DOE, dyspnea on exertion; LE, lower extremity; NYHA, New York Heart Association; LVEF, left ventricular ejection fraction; LV, left ventricle; RVF, right ventricular function; RV, right ventricle; RVSP, right ventricular systolic pressure; TR, tricuspid regurgitation; PVL, paravalvular leak.
Discussion
In the current study, we evaluated the safety and efficacy of TViV in a single center registry. In this study, the TViV provided an effective and safe alternative to surgery in patients with high to prohibitive surgical risk. Our findings are in line with previously published data from 306 patients who underwent transcatheter tricuspid valve replacement (TViV or TViR) (10), demonstrating the feasibility and safety of the procedure. In the current study, all patients reported significant clinical improvement. Follow-up echocardiography confirmed the absence of significant TR (central or paravalvular) in all patients.
Transcatheter valve sizing
The planning of a TViV or TViR procedure includes the identification of the surgical prosthesis and transcatheter valve size. For TViV, examination of the surgical implant information (prosthesis card or surgical note) and multimodality imaging are used in order to determine the true internal diameter of the surgical prosthesis, to enable an accurate THV sizing. For this purpose, computed tomography (CT) imaging should be performed in all cases (Figure 1), if kidney function allows, particularly in TViR, or in cases where the surgical valve size is unknown. Alternatively, particularly in patients with kidney dysfunction, transesophageal echocardiography (TEE) should be performed. Both modalities (CT and TEE) also provide additional important information, such as the presence of PVL, prosthesis thrombus or infective endocarditis, as these are exclusion criteria for transcatheter TViV or TViR. Due to the presence of the mounted leaflets inside the valve prosthesis, the true internal diameter is typically 1 to 2 mm smaller than the diameter of the surgical valve prosthesis size reported by the manufacturer (16). As there are no dedicated surgical bioprostheses for the tricuspid position, the mitral Valve-in-Valve app (17) can be used to identify the surgical prosthesis type and guide THV size selection and positioning. If a Melody valve (Medtronic PLC, Minneapolis, Minnesota) is implanted, balloon sizing of the existing bioprosthesis is usually performed to profile the waist of the existing bioprosthesis (18). In the case of TViR, CT and balloon-sizing are useful in THV sizing.
Transcatheter valve selection
Valve selection is guided by the patient’s anatomy and the size of the surgical prosthesis. In general, the Melody valve is preferable for a surgical bioprosthesis with an inner diameter of ≤23 mm (Melody valve inner diameter 22 mm, outer diameter 24 mm), and the Edwards SAPIEN 3 valve for a surgical bioprosthesis with an inner diameter of ≥29 mm (SAPIEN 3 valve is available in sizes up to 29 mm, which can be over-expanded up to 31 mm) (18). For a surgical bioprosthesis with an outer diameter between 25 and 29 mm, both THVs can be used. While the Melody valve is mounted in the standard fashion, a SAPIEN 3 valve must be mounted for antegrade delivery onto the delivery catheter, and the valve delivery system introduced with the Edwards ‘E’ logo facing downward, in order to allow for appropriate flexion of the catheter.
Transcatheter valve positioning and implantation
The procedure is performed under fluoroscopy and echocardiography guidance [transthoracic echocardiography (TTE) or TEE]; both moderate sedation and general anesthesia can be used, depending on patient-related risk factors. The procedure can be performed via a transfemoral or a transjugular route. However, transfemoral access has become the most frequently used route with the development of more directable and flexible valve delivery systems, which have allowed for operators to overcome the acute angle between the inferior vena cava and the tricuspid valve. After obtaining femoral vein access with a five French sheath system, pre-close is typically performed with one Perclose ProGlide suture-mediated closure system. The sheath is then replaced with a dedicated large sheath (14–16 French) and the tricuspid valve is crossed with a straight-tip wire (stiff glidewire for TS or tiger-wire for TR). This wire is replaced with a pre-formed stiff wire which is positioned through the surgical bioprosthesis at the RV apex. Special attention should be paid to confirm that the stiff wire is crossing within the bioprosthesis rather than through a PVL. The selected THV is advanced to the deployment position: for surgical prostheses with a visible stent frame, the central marker of the SAPIEN 3 valve should be aligned 3 mm ventricular to the atrial edge of surgical bioprosthesis stent frame, while for surgical valves with visible outflow markers, the outflow of the crimped SAPIEN 3 valve should be aligned 1−2 mm atrial to the ventricular surgical valve outflow markers. For surgical valves with no radiopaque markers, the base of the central SAPIEN 3 marker should be aligned with the annular plane. A sample video is shown (Video 1). The Melody valve is typically implanted with about 40% of the stent frame on the atrial side (18). The primary principle for deployment is: (I) anchor the transcatheter valve at the sewing ring of the surgical, and (II) land the THV such that leaflet overhang of the surgical prosthesis does not occur. The foreshortening of the SAPIEN 3 valve frame occurs from the inflow, corresponding to the right atrial side of the valve.
In cases of TViR implantation, it is important to determine whether the prosthesis is a ring or a band, complete or incomplete and flexible, rigid or semirigid. Compared with rigid or semirigid bands and complete rings, flexible bands are more challenging for THV anchoring, as they may expand during THV deployment. In fact, flexible bands convey the highest risk for THV embolization, which should be taken into consideration before performing TViR in such prostheses. On the other hand, the flexible bands have a lower risk of paravalvular leak, as semi-rigid and rigid rings will not circularize. The resulting PVL can be severe and/or require PVL closure. In the case of TViR, the central marker of the SAPIEN 3 prosthesis should be aligned 2 mm ventricular to the annular ring. Caution should be undertaken before proceeding with any TViR, due to the much higher risks and lower chance of procedural success.
Once the THV is positioned appropriately across the surgical prosthesis, it should be deployed in a slow and controlled fashion to allow for adjustment of the THV position as needed. In most cases THV deployment can be performed without pacing. In cases of excessive cardiac motion, pacing can be performed in the coronary sinus, or through the stiff wire located in the RV apex. In the case of a pre-existing permanent pacemaker, jailing of its leads by the THV is usually well tolerated, and does not cause significant PVL. Close coordination between the two implanters and a slow deployment, with continuous adjustment, is required for accurate positioning. Additional guidance for deployment can be found on the VIV app.
Limitations
The current study intends to describe our primary experience with TViV and includes a small number of patients. All transcatheter valve implantations were performed for degenerative tricuspid bioprosthesis and none were performed for failed tricuspid ring. In addition, patients were carefully selected and approved by a local heart team. As such, the results presented above cannot be generalized to all patients with surgical prosthesis failure and should be carefully interpreted. Follow up is limited to 30 days and long term follow up and data regarding the longevity of TViV are not available. Nevertheless, data presented above support previous reports that in selected patients with surgical prosthesis failure, TViV or TViR is a feasible and safe procedure. The THV durability and long-term clinical outcomes are still unknown, as are the risk for leaflet thrombosis and endocarditis. Accordingly, the optimal medical treatment regimen after TViV or TViR (aspirin, dual anti-platelets, or anticoagulation) is yet to be determined.
Acknowledgments
Funding: None.
Footnote
Conflicts of Interest: IG: CardioMech, VDyne, Atricure, ValCare Medical, MitreMedical, J&J. SC and LD: none.
Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.
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