Background
Doppler-derived hemodynamic data for normal tricuspid valve bioprostheses are limited.
Methods
A comprehensive retrospective Doppler echocardiographic assessment of 285 normal Carpentier-Edwards Duraflex, Medtronic Mosaic, St. Jude Medical Biocor, Carpentier-Edwards Perimount, and Medtronic Hancock II tricuspid valve bioprostheses was performed early after implantation. All the important Doppler-derived hemodynamic variables reported to date for mitral valve prostheses were used. Mean values for hemodynamic variables were obtained by averaging measurements of five and nine consecutive cardiac cycles.
Results
No clinically significant difference was found in the mean values obtained for the Doppler parameters when measurements were averaged from five or nine consecutive cardiac cycles. The mean value for the mean gradient was 5.2 mm Hg. Regardless of valve type and body surface area, pressure half-time was <200 msec for all 76 patients in whom it could be measured. Mean gradient <9 mm Hg, E velocity <2.1 m/sec, time-velocity integral of the tricuspid valve prosthesis <66 cm, and ratio of the time-velocity integral of the tricuspid valve prosthesis to the time-velocity integral of the left ventricular outflow tract <3.3 were recorded in 254 of the 285 patients (89%).
Conclusions
This study establishes parameters for Doppler-derived hemodynamic data for various types of normal tricuspid valve bioprostheses. These threshold values (mean + 2 standard deviations) are specific, but not sensitive, for identifying tricuspid valve bioprosthesis dysfunction. Prostheses with hemodynamic values that are higher than these threshold values are likely dysfunctional, but in select cases, tricuspid valve bioprosthesis dysfunction may be present even when hemodynamic values are lower than these thresholds.
Two-dimensional echocardiography combined with Doppler is the preferred method for assessing prosthetic valve function. Clinically useful Doppler-derived measures for assessing prosthetic mitral valve hemodynamic properties have been published previously, but Doppler data for prosthetic tricuspid valves are limited. Several studies have proposed normal parameters for mean gradient (MG), peak early tricuspid diastolic velocity (E velocity), and pressure half-time (PHT) for various tricuspid valve prostheses, but these studies included only a small number of patients with older types of prostheses.
Numerous mitral valve prosthesis studies, including several from our institution, have documented that clinically useful parameters for assessing mitral valve prosthesis function are the ratio of the time-velocity integral of the mitral valve prosthesis (TVI MVP ) to the time-velocity integral of the left ventricular outflow tract (TVI LVOT ), effective orifice area (EOA), and indexed EOA (IEOA). Similarly, we posit that the ratio of the time-velocity integral of the tricuspid valve prosthesis (TVI TVP ) to the TVI LVOT , EOA, and IEOA is clinically useful when assessing tricuspid valve prosthesis function. TVI TVP itself is also likely to be an important variable to consider. Reference (normal) parameters for TVI TVP , TVI TVP /TVI LVOT , EOA, and IEOA have not previously been published for any tricuspid valve prosthesis. Because of the large variability in Doppler measurements for each prosthesis type and size, it is important to establish reference values to identify probable normal and abnormal prosthesis function.
In vivo Doppler hemodynamic investigations are limited for tricuspid valve bioprostheses. To our knowledge, only two previous studies have reported Doppler-derived hemodynamic profiles for different sizes of normally functioning tricuspid valve bioprostheses. In these small studies, Doppler measurements were limited to E velocity, PHT, and MG. The purpose of this retrospective study was to define normal Carpentier-Edwards Duraflex (CED; Edwards Lifesciences, LLC, Irvine, CA), Medtronic Mosaic (MM; Medtronic, Inc., Minneapolis, MN), St. Jude Medical Biocor (SJMB; St. Jude Medical, Inc., St Paul, MN), Carpentier-Edwards Perimount (CEP; Edwards Lifesciences, LLC), and Medtronic Hancock II (HKII; Medtronic, Inc.) tricuspid valve bioprosthesis function in the early postoperative period, using all the important Doppler-derived hemodynamic variables described to date in the medical literature for mitral valve prostheses.
Methods
The study was approved by the Mayo Clinic Institutional Review Board. All study patients provided written informed consent to allow the use of their medical records for research purposes. No industry support was provided.
Patient Selection
From the cardiac surgical database of Mayo Clinic (Rochester, MN), we identified 763 patients aged ≥18 years who underwent tricuspid valve replacement between January 1, 1993, and December 31, 2007. Of these 763 patients, 606 had tricuspid valve bioprostheses implanted. Of the 606 patients, 397 (66%) received CED valves, 93 (15%) received MM valves, 63 (10%) received SJMB valves, 33 (5%) received HKII valves, and 20 (3%) received CEP valves. Three hundred twenty-one patients who met the prespecified exclusion criteria were omitted from the study: 34 patients died within 30 days of surgery, 24 patients did not undergo intraoperative transesophageal echocardiography (TEE), 33 patients did not have transthoracic echocardiography (TTE) performed within 30 days of surgery, 31 patients had signs of possible tricuspid prosthesis stenosis or regurgitation on intraoperative TEE or postoperative TTE, 10 patients were on vasopressors at the time of postoperative TTE, 33 patients had heart rates ≥100 beats/min, 153 patients had inadequate images for obtaining accurate and complete Doppler data on postoperative TTE, and three patients underwent Glenn procedures. The remaining 285 patients constituted the study population: 177 patients with the CED bioprosthesis, 49 patients with the MM bioprosthesis, 36 patients with the SJMB bioprosthesis, 12 patients with the CEP bioprosthesis, and 11 patients with the HKII bioprosthesis.
All bioprostheses appeared to be functioning normally on physical examination and by their appearance on both intraoperative TEE and TTE performed <30 days after surgery. No patient had greater than mild tricuspid regurgitation or pulmonary regurgitation by intraoperative TEE or postoperative TTE.
Echocardiographic Data
Left ventricular ejection fraction was obtained using either the M mode or a two-dimensional modification of the Quinones method. If these measurements were inadequate, left ventricular ejection fraction was estimated visually. Also noted were presence and severity of pulmonary regurgitation and tricuspid transprosthetic or periprosthetic regurgitation.
Doppler data were obtained from tapes using DigiView Release version 3.6.3 (Digisonics, Inc., Houston, TX) or from digital images using ProSolv (ProSolv CardioVascular, Indianapolis, IN) for off line analysis by one of the investigators (L.A.B.).
The standard practice at our institution is to average three cycles of the left-heart Doppler measurements if patients are in sinus rhythm and to average at least five cycles if patients have atrial fibrillation or another irregular rhythm. For tricuspid prosthesis Doppler measurements, at least nine or 10 cycles are usually averaged, regardless of rhythm, because of respiratory variation in the velocities. For patients with irregular rhythms, attempts are made whenever possible to use periods of physiologic heart rate and to match the nine or 10 cycle lengths that are used for each parameter. The number of cycles and the individual measurements are approved by the supervising echocardiographer before inclusion in the final report. For this study, Doppler measurements for each tricuspid valve bioprosthesis were recorded for nine consecutive cardiac cycles, and measurements were recorded as averages of the first five cycles and as averages of all nine cycles.
For the identification of possible tricuspid valve bioprosthesis dysfunction, threshold values for abnormal MG, E velocity, TVI TVP , TVI TVP /TVI LVOT , and PHT were determined by calculating the mean + 2 SDs for each variable. The bioprosthesis EOA was calculated by using the continuity equation (EOA = stroke volume/TVI TVP ) and the PHT method (EOA = c /PHT, where c is a constant) to compare these methods with each other for these specific prostheses. EOA PHT calculations were performed using two constants, c = 220 and c = 190. Continuous-wave Doppler measurements were used for PHT and TVI TVP .
Stroke volume was calculated as the product of the left ventricular outflow tract area and the TVI LVOT measured with pulsed-wave Doppler. The prosthesis performance index (PPI) was calculated as the ratio of the EOA derived by the continuity equation to the geometric orifice area provided by the manufacturer: 4.90, 5.72, 6.60, 7.54, and 8.55 cm 2 for the 27-mm, 29-mm, 31-mm, 33-mm, and 35-mm CED valves, respectively (information provided by Edwards Lifesciences); 3.97, 4.52, 5.30, 6.15, and 7.07 cm 2 for the 25-mm, 27-mm, 29-mm, 31-mm, and 33-mm MM valves, respectively (information provided by Medtronic); 5.72, 6.60, and 7.54 cm 2 for the 29-mm, 31-mm, and 33-mm SJMB valves, respectively (information provided by St. Jude Medical); 6.60, 7.54, and 8.55 cm 2 for the 29-mm, 31-mm, and 33-mm CEP valves, respectively (information provided by Edwards Lifesciences); and 6.15, 7.07, and 8.04 cm 2 for the 31-mm, 33-mm, and 35-mm HKII valves, respectively (information provided by Medtronic). Other calculated variables included IEOA and TVI TVP /TVI LVOT .
Tricuspid valve prosthesis-patient mismatch (PPM) was assessed by calculating the IEOA using the continuity equation. The threshold value for delineating severe tricuspid PPM (IEOA ≤0.9 cm 2 /m 2 ) was chosen on the basis of the results of previously published studies analyzing prostheses in the mitral valve position.
Statistical Analysis
Measurements calculated by the continuity equation and the PHT method (using both constants) were compared by using the paired t test. Continuous variables were compared among the various valve size groups by using analysis of variance. Differences were considered significant at P < .05. Significant differences were investigated by adjusting for multiple comparisons using the Student-Newman-Kuels procedure.
Results
Clinical Characteristics
The characteristics of the 285 patients who had tricuspid valve bioprostheses implanted are summarized in Tables 1 to 5 . The most common indications for tricuspid valve replacement were nonrheumatic tricuspid valve regurgitation in 81 patients (28%), unrepairable Ebstein anomaly in 76 patients (27%), carcinoid heart disease in 46 patients (16%), and probable device lead–induced tricuspid regurgitation in 34 patients (12%). Two hundred thirty-two patients (81%) had TTE performed within the first week after tricuspid valve replacement. In the 285 patients, the heart rhythm was sinus in 171 patients (60%), paced in 63 (22%), atrial fibrillation in 44 (15%), atrial flutter in four (1%), and junctional in three (1%). Of the 63 patients with paced heart rhythm, 40 (63%) had permanent pacemakers implanted before tricuspid valve replacement surgery, eight (13%) required placement of permanent pacemakers with epicardial leads at the time of surgery, 10 (16%) required placement of permanent pacemakers with transvenous right ventricular leads placed across the tricuspid valve prosthesis after surgery but before the predischarge TTE, and five (8%) were paced with temporary pacing wires at the time of the TTE.
| Prosthesis size (mm) | |||||||
|---|---|---|---|---|---|---|---|
| 27 | 29 | 31 | 33 | 35 | All patients ( N = 177) | ||
| Characteristic | ( n = 13) | ( n = 23) | ( n = 36) | ( n = 44) | ( n = 61) | Mean ± SD | Range |
| Age (years) | 62 ± 16.7 | 54 ± 18.7 | 60 ± 15.9 | 55 ± 20.3 | 48 ± 19.2 | 54 ± 19.1 | 18–89 |
| Women | 10 (77%) | 18 (78%) | 22 (61%) | 27 (61%) | 29 (48%) | 106 (60%) | NA |
| Congenital heart disease | |||||||
| Any disease | 1 (8%) | 6 (26%) | 6 (17%) | 16 (36%) | 44 (72%) | 73 (41%) | NA |
| Ebstein anomaly | 0 (0%) | 2 (9%) | 4 (11%) | 10 (23%) | 44 (72%) | 60 (34%) | NA |
| Heart rate (beats/min) | 78 ± 11.2 | 81 ± 10.2 | 78 ± 9.6 | 79 ± 10.6 | 78 ± 11.7 | 79 ± 10.7 | 50–99 |
| Hemoglobin (g/dL) | 9.9 ± 0.65 | 10.2 ± 1.24 | 10.6 ± 1.22 | 10.6 ± 1.27 | 10.5 ± 1.48 | 10.5 ± 1.30 | 7.7–17.5 |
| Hematocrit (%) | 29.4 ± 1.97 | 30.0 ± 3.66 | 31.3 ± 3.49 | 31.2 ± 3.71 | 30.7 ± 4.39 | 30.8 ± 3.82 | 22.1–52.2 |
| BSA (m 2 ) | 1.74 ± 0.17 | 1.75 ± 0.22 | 1.80 ± 0.22 | 1.86 ± 0.26 | 1.88 ± 0.26 | 1.83 ± 0.25 | 1.40–2.57 |
| LVEF (%) ∗ | 59 ± 13.9 | 61 ± 7.6 | 59 ± 11.9 | 60 ± 9.2 | 56 ± 12.0 | 58 ± 11.0 | 20–79 |
| LVEF < 50% | 3 (23%) | 1 (4%) | 4 (11%) | 5 (11%) | 9 (15%) | 22 (12%) | 20–49 |
| SV (mL) | 61 ± 11.3 | 70 ± 19.9 | 73 ± 14.0 | 77 ± 19.7 | 74 ± 19.4 | 73 ± 18.3 | 45–149 |
| SVI (mL/m 2 ) | 36 ± 7.9 | 40 ± 7.3 | 41 ± 7.0 | 42 ± 9.9 | 39 ± 8.5 | 40 ± 8.5 | 26–66 |
| PHT (m/sec) † | 130 ± 45.4 ( n = 6) | 102 ± 26.5 ( n = 7) | 115 ± 40.8 ( n = 14) | 116 ± 39.7 ( n = 9) | 83 ± 26.5 ( n = 10) | 108 ± 38.2 ( n = 46) | 38–196 |
| MG (mm Hg) | 5.2 ± 1.69 | 6.0 ± 1.95 | 5.7 ± 1.67 | 5.6 ± 2.10 | 5.3 ± 1.61 | 5.5 ± 1.80 | 2–10 |
| E velocity (m/s) | 1.5 ± 0.26 | 1.7 ± 0.27 | 1.5 ± 0.27 | 1.5 ± 0.26 | 1.5 ± 0.25 | 1.5 ± 0.26 | 0.9–2.2 |
| TVI TVP (cm) | 46 ± 8.0 | 47 ± 9.6 | 48 ± 9.0 | 47 ± 10.2 | 46 ± 10.5 | 47 ± 9.8 | 25–69 |
| TVI TVP /TVI LVOT | 2.4 ± 0.40 | 2.3 ± 0.60 | 2.3 ± 0.53 | 2.3 ± 0.54 | 2.3 ± 0.54 | 2.3 ± 0.53 | 1.3–3.6 |
| EOA (cm 2 ) | |||||||
| CON | 1.34 ± 0.22 | 1.54 ± 0.38 | 1.57 ± 0.39 | 1.69 ± 0.44 | 1.63 ± 0.38 | 1.60 ± 0.39 | 0.79–2.95 |
| PHT ( c = 190) | 1.62 ± 0.54 | 1.97 ± 0.48 | 1.93 ± 1.00 | 1.83 ± 0.69 | 2.54 ± 0.93 | 2.01 ± 0.84 | 0.97–5.00 |
| PHT ( c = 220) | 1.87 ± 0.63 | 2.28 ± 0.55 | 2.23 ± 1.16 | 2.12 ± 0.80 | 2.94 ± 1.08 | 2.32 ± 0.97 | 1.12–5.79 |
| IEOA (cm 2 /m 2 ) | |||||||
| CON | 0.78 ± 0.15 | 0.88 ± 0.19 | 0.88 ± 0.22 | 0.92 ± 0.24 | 0.88 ± 0.22 | 0.88 ± 0.22 | 0.50–1.59 |
| PHT ( c = 190) | 0.96 ± 0.31 | 1.12 ± 0.25 | 1.16 ± 0.74 | 1.04 ± 0.39 | 1.42 ± 0.53 | 1.16 ± 0.53 | 0.57–3.50 |
| PHT ( c = 220) | 1.11 ± 0.36 | 1.30 ± 0.29 | 1.34 ± 0.86 | 1.21 ± 0.45 | 1.64 ± 0.62 | 0.34 ± 0.62 | 0.66–4.05 |
| PPI CON | 0.27 ± 0.04 | 0.27 ± 0.07 | 0.24 ± 0.06 | 0.22 ± 0.06 | 0.19 ± 0.04 | 0.23 ± 0.06 | 0.10–0.45 |
∗ Obtained by visual estimate ( n = 97 [55%]), M-mode measurement ( n = 42 [24%]), or two-dimensional measurement ( n = 38 [21%]).
† Values are the means of 5 cardiac cycles for all Doppler measurements and calculations using Doppler measurements.
| Prosthesis size (mm) | |||||||
|---|---|---|---|---|---|---|---|
| 25 | 27 | 29 | 31 | 33 | All patients ( N = 49) | ||
| Characteristic | ( n = 1) | ( n = 4) | ( n = 8) | ( n = 24) | ( n = 12) | Mean ± SD | Range |
| Age (years) | 35 | 49 ± 26.3 | 61 ± 11.3 | 62 ± 17.9 | 62 ± 18.1 | 60 ± 17.8 | 19–90 |
| Women | 1 (100%) | 3 (75%) | 8 (100%) | 16 (67%) | 4 (33%) | 32 (65%) | NA |
| Congenital heart disease | |||||||
| Any disease | 1 (100%) | 2 (50%) | 0 (0%) | 3 (12%) | 5 (42%) | 11 (22%) | NA |
| Ebstein anomaly | 1 (100%) | 1 (25%) | 0 (0%) | 3 (12%) | 5 (42%) | 10 (20%) | NA |
| Heart rate (beats/min) | 90 | 69 ± 6.7 | 82 ± 8.5 | 75 ± 10.6 | 78 ± 11.6 | 76 ± 10.6 | 50–99 |
| Hemoglobin (g/dL) | 10.1 | 9.7 ± 1.49 | 9.4 ± 0.90 | 10.5 ± 1.23 | 10.6 ± 0.94 | 10.2 ± 1.18 | 8.1–13.4 |
| Hematocrit (%) | 30.1 | 28.3 ± 4.09 | 27.8 ± 2.79 | 30.8 ± 3.61 | 31.3 ± 2.94 | 30.2 ± 3.48 | 23.6–40.0 |
| BSA (m 2 ) | 1.47 | 1.81 ± 0.24 | 1.75 ± 0.17 | 1.86 ± 0.31 | 2.00 ± 0.31 | 1.86 ± 0.29 | 1.06–2.79 |
| LVEF (%) ∗ | 35 | 64 ± 4.4 | 65 ± 5.1 | 56 ± 12.6 | 59 ± 8.7 | 58 ± 11.1 | 20–75 |
| LVEF < 50% | 1 (100%) | 0 (0%) | 0 (0%) | 6 (25%) | 1 (8%) | 8 (16%) | 20–49 |
| SV (mL) | 48 | 77 ± 10.4 | 71 ± 15.1 | 78 ± 19.4 | 78 ± 14.7 | 76 ± 17.1 | 48–117 |
| SVI (mL/m 2 ) | 33 | 43 ± 7.8 | 40 ± 6.7 | 42 ± 9.8 | 39 ± 5.5 | 41 ± 8.2 | 28–64 |
| PHT (m/sec) † | 80 ( n = 1) | NR | 115 ± 13.4 ( n = 2) | 144 ± 28.6 ( n = 5) | 139 ± 56.5 ( n = 4) | 132 ± 39.6 ( n = 12) | 64–194 |
| MG (mm Hg) | 4.0 | 5.5 ± 0.58 | 6.0 ± 2.00 | 5.2 ± 1.43 | 4.3 ± 1.30 | 5.1 ± 1.52 | 2–9 |
| E velocity (m/s) | 1.6 | 1.6 ± 0.17 | 1.5 ± 0.26 | 1.5 ± 0.21 | 1.4 ± 0.19 | 1.5 ± 0.21 | 1.1–1.9 |
| TVI TVP (cm) | 35 | 51 ± 6.8 | 37 ± 9.7 | 46 ± 9.5 | 40 ± 8.6 | 43 ± 9.7 | 24–60 |
| TVI TVP /TVI LVOT | 3.2 | 2.2 ± 0.40 | 1.8 ± 0.39 | 2.2 ± 0.60 | 2.1 ± 0.30 | 2.1 ± 0.53 | 1.2–3.3 |
| EOA (cm 2 ) | |||||||
| CON | 1.37 | 1.53 ± 0.16 | 1.96 ± 0.39 | 1.74 ± 0.52 | 2.00 ± 0.53 | 1.81 ± 0.49 | 1.09–3.13 |
| PHT ( c = 190) | 2.38 | NR | 1.67 ± 0.20 | 1.37 ± 0.29 | 1.64 ± 0.91 | 1.59 ± 0.58 | 0.95–2.97 |
| PHT ( c = 220) | 2.75 | NR | 1.94 ± 0.23 | 1.59 ± 0.34 | 1.90 ± 1.05 | 1.84 ± 0.67 | 1.10–3.44 |
| IEOA (cm 2 /m 2 ) | |||||||
| CON | 0.93 | 0.86 ± 0.18 | 1.12 ± 0.21 | 0.95 ± 0.29 | 1.01 ± 0.26 | 0.98 ± 0.27 | 0.55–1.66 |
| PHT ( c = 190) | 1.62 | NR | 1.00 ± 0.15 | 0.82 ± 0.19 | 0.88 ± 0.48 | 0.93 ± 0.36 | 0.49–1.62 |
| PHT ( c = 220) | 1.87 | NR | 1.16 ± 0.18 | 0.95 ± 0.21 | 1.02 ± 0.56 | 1.08 ± 0.41 | 0.57–1.87 |
| PPI CON | 0.35 | 0.34 ± 0.03 | 0.37 ± 0.07 | 0.28 ± 0.08 | 0.28 ± 0.08 | 0.30 ± 0.08 | 0.18–0.51 |
∗ Obtained by visual estimate ( n = 23 [47%]), two-dimensional measurement ( n = 20 [41%]), or M-mode measurement ( n = 6 [12%]).
† Values are the means of 5 cardiac cycles for all Doppler measurements and calculations using Doppler measurements.
| Prosthesis size (mm) | |||||
|---|---|---|---|---|---|
| 29 | 31 | 33 | All patients ( N = 36) | ||
| Characteristic | ( n = 1) | ( n = 9) | ( n = 26) | Mean ± SD | Range |
| Age (years) | 63 | 52 ± 22.4 | 63 ± 17.7 | 60 ± 19.0 | 19–89 |
| Women | 1 (100%) | 9 (100%) | 13 (50%) | 23 (64%) | NA |
| Congenital heart disease | |||||
| Any disease | 0 (0%) | 4 (44%) | 7 (27%) | 11 (31%) | NA |
| Ebstein anomaly | 0 (0%) | 4 (44%) | 7 (27%) | 11 (31%) | NA |
| Heart rate (beats/min) | 60 | 76 ± 10.4 | 76 ± 11.8 | 76 ± 11.5 | 52–98 |
| Hemoglobin (g/dL) | 9.3 | 10.8 ± 1.39 | 10.5 ± 1.09 | 10.5 ± 1.22 | 8.1–13.6 |
| Hematocrit (%) | 27.9 | 31.5 ± 4.12 | 30.9 ± 3.30 | 30.9 ± 3.47 | 24.2–40.9 |
| BSA (m 2 ) | 1.85 | 1.69 ± 0.12 | 1.82 ± 0.12 | 1.79 ± 0.20 | 1.44–2.35 |
| LVEF (%) ∗ | 66 | 65 ± 5.1 | 59 ± 11.1 | 61 ± 10.1 | 35–75 |
| LVEF < 50% | 0 (0%) | 0 (0%) | 5 (19%) | 5 (14%) | 35–46 |
| SV (mL) | 122 | 75 ± 21.9 | 72 ± 17.5 | 74 ± 19.9 | 41–122 |
| SVI (mL/m 2 ) | 66 | 44 ± 10.8 | 40 ± 98.8 | 42 ± 10.2 | 25–66 |
| PHT (m/sec) † | NR | 106 ± 48.5 ( n = 5) | 125 ± 45.7 ( n = 7) | 117 ± 45.7 ( n = 12) | 48–189 |
| MG (mm Hg) | 6.0 | 5.1 ± 1.36 | 3.9 ± 1.20 | 4.3 ± 1.34 | 2–7 |
| E velocity (m/s) | 1.6 | 1.5 ± 0.34 | 1.3 ± 0.23 | 1.4 ± 0.28 | 1.0–2.2 |
| TVI TVP (cm) | 43 | 46 ± 12.5 | 39 ± 10.0 | 41 ± 10.8 | 24–64 |
| TVI TVP /TVI LVOT | 1.7 | 2.2 ± 0.57 | 1.9 ± 0.56 | 2.0 ± 0.56 | 1.0–3.4 |
| EOA (cm 2 ) | |||||
| CON | 2.84 | 1.67 ± 0.30 | 1.92 ± 0.50 | 1.88 ± 0.49 | 1.15–3.63 |
| PHT ( c = 190) | NR | 2.19 ± 1.12 | 1.77 ± 0.81 | 1.94 ± 0.93 | 1.01–3.96 |
| PHT ( c = 220) | NR | 2.53 ± 1.30 | 2.04 ± 0.94 | 2.25 ± 1.07 | 1.16–4.58 |
| IEOA (cm 2 /m 2 ) | |||||
| CON | 1.54 | 0.99 ± 0.19 | 1.07 ± 0.29 | 1.06 ± 0.28 | 0.63–1.91 |
| PHT ( c = 190) | NR | 1.33 ± 0.58 | 1.09 ± 0.46 | 1.18 ± 0.51 | 0.56–2.31 |
| PHT ( c = 220) | NR | 1.51 ± 0.72 | 1.18 ± 0.62 | 1.31 ± 0.65 | 0.63–2.56 |
| PPI CON | 0.50 | 0.25 ± 0.05 | 0.25 ± 0.07 | 0.26 ± 0.07 | 0.15–0.50 |
∗ Obtained by two-dimensional estimate ( n = 17 [47%]), visual measurement ( n = 11 [31%]), or M-mode measurement ( n = 8 [22%]).
† Values are the means of 5 cardiac cycles for all Doppler measurements and calculations using Doppler measurements.
| Prosthesis size (mm) | |||||
|---|---|---|---|---|---|
| 29 | 31 | 33 | All patients ( N = 12) | ||
| Characteristic | ( n = 2) | ( n = 3) | ( n = 7) | Mean ± SD | Range |
| Age (years) | 46 ± 17.0 | 50 ± 19.6 | 71 ± 4.9 | 62 ± 15.7 | 30–76 |
| Women | 2 (100%) | 3 (100%) | 4 (57%) | 9 (75%) | NA |
| Congenital heart disease | |||||
| Any disease | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | NA |
| Ebstein anomaly | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | NA |
| Heart rate (beats/min) | 84 ± 8.5 | 82 ± 2.7 | 76 ± 8.9 | 79 ± 8.1 | 62–90 |
| Hemoglobin (g/dL) | 12.0 ± 0.85 | 8.9 ± 1.80 | 10.4 ± 0.80 | 10.3 ± 1.44 | 7.4–12.6 |
| Hematocrit (%) | 35.7 ± 3.04 | 25.5 ± 5.66 | 30.5 ± 2.01 | 30.1 ± 4.51 | 20.6–37.8 |
| BSA (m 2 ) | 1.58 ± 0.17 | 1.77 ± 0.14 | 1.86 ± 0.16 | 1.79 ± 0.18 | 1.46–2.07 |
| LVEF (%) ∗ | 73 ± 3.5 | 69 ± 4.7 | 55 ± 14.8 | 61 ± 13.7 | 25–75 |
| LVEF < 50% | 0 (0%) | 0 (0%) | 1 (14%) | 1 (8%) | 25 |
| SV (mL) | 61 ± 2.8 | 75 ± 1.5 | 74 ± 27.4 | 72 ± 20.9 | 48–111 |
| SVI (mL/m 2 ) | 39 ± 2.4 | 42 ± 3.2 | 39 ± 12.6 | 40 ± 9.5 | 25–57 |
| PHT (m/sec) † | 94 ± 2.8 ( n = 2) | 74 ± 26.2 ( n = 2) | 137 ± 53.0 ( n = 2) | 101 ± 39.1 ( n = 6) | 55–174 |
| MG (mm Hg) | 2.0 ± 1.41 | 3.7 ± 1.53 | 3.9 ± 1.07 | 3.5 ± 1.31 | 1–5 |
| E velocity (m/s) | 1.1 ± 0.21 | 1.2 ± 0.20 | 1.4 ± 0.21 | 1.3 ± 0.24 | 0.9–1.7 |
| TVI TVP (cm) | 29 ± 7.1 | 37 ± 9.1 | 38 ± 7.9 | 36 ± 8.0 | 24–52 |
| TVI TVP /TVI LVOT | 1.6 ± 0.20 | 1.7 ± 0.35 | 1.9 ± 0.28 | 1.8 ± 0.29 | 1.3–2.4 |
| EOA (cm 2 ) | |||||
| CON | 2.16 ± 0.43 | 2.12 ± 0.53 | 1.93 ± 0.43 | 2.02 ± 0.42 | 1.41–2.70 |
| PHT ( c = 190) | 2.03 ± 0.06 | 2.76 ± 0.98 | 1.51 ± 0.59 | 2.10 ± 0.76 | 1.09–3.45 |
| PHT ( c = 220) | 2.34 ± 0.07 | 3.20 ± 1.14 | 1.74 ± 0.68 | 2.43 ± 0.88 | 1.26–4.00 |
| IEOA (cm 2 /m 2 ) | |||||
| CON | 1.39 ± 0.42 | 1.20 ± 0.29 | 1.03 ± 0.19 | 1.13 ± 0.27 | 0.80–1.68 |
| PHT ( c = 190) | 1.29 ± 0.10 | 1.61 ± 0.49 | 0.88 ± 0.45 | 1.26 ± 0.45 | 0.56–1.96 |
| PHT ( c = 220) | 1.49 ± 0.11 | 1.87 ± 0.57 | 1.02 ± 0.52 | 1.46 ± 0.52 | 0.65–2.27 |
| PPI CON | 0.36 ± 0.07 | 0.31 ± 0.08 | 0.28 ± 0.06 | 0.30 ± 0.07 | 0.21–0.41 |
∗ Obtained by visual estimate ( n = 6 [50%]), two-dimensional measurement ( n = 5 [42%]), or M-mode measurement ( n = 1 [8%]).
† Values are the means of 5 cardiac cycles for all Doppler measurements and calculations using Doppler measurements.
| Prosthesis size (mm) | |||||
|---|---|---|---|---|---|
| 31 | 33 | 35 | All patients ( N = 11) | ||
| Characteristic | ( n = 6) | ( n = 2) | ( n = 3) | Mean ± SD | Range |
| Age (years) | 58 ± 16.5 | 54 ± 25.5 | 54 ± 12.4 | 56 ± 15.4 | 33–77 |
| Women | 4 (67%) | 1 (50%) | 0 (0%) | 5 (45%) | NA |
| Congenital heart disease | |||||
| Any disease | 1 (17%) | 1 (50%) | 3 (100%) | 5 (45%) | NA |
| Ebstein anomaly | 0 (0%) | 1 (50%) | 3 (100%) | 4 (36%) | NA |
| Heart rate (beats/min) | 73 ± 12.8 | 75 ± 2.8 | 79 ± 5.1 | 75 ± 9.8 | 56–90 |
| Hemoglobin (g/dL) | 11.0 ± 1.58 | 9.8 ± 1.48 | 9.4 ± 1.35 | 10.3 ± 1.54 | 8.3–12.8 |
| Hematocrit (%) | 32.3 ± 4.72 | 28.5 ± 4.67 | 27.4 ± 4.02 | 30.3 ± 4.70 | 23.9–37.4 |
| BSA (m 2 ) | 1.85 ± 0.21 | 1.96 ± 0.18 | 2.12 ± 0.31 | 1.94 ± 0.24 | 1.60–2.47 |
| LVEF (%) ∗ | 60 ± 4.5 | 55 ± 20.5 | 59 ± 6.6 | 59 ± 8.1 | 40–69 |
| LVEF < 50% | 0 (0%) | 1 (50%) | 0 (0%) | 1 (9%) | 40 |
| SV (mL) | 67 ± 8.9 | 65 ± 6.4 | 88 ± 14.8 | 72 ± 13.7 | 53–104 |
| SVI (mL/m 2 ) | 37 ± 7.7 | 33 ± 0.3 | 42 ± 11.3 | 38 ± 8.1 | 26–55 |
| PHT (m/sec) † | NR | NR | NR | NR | NR |
| MG (mm Hg) | 5.7 ± 1.37 | 5.5 ± 3.54 | 5.3 ± 0.58 | 5.6 ± 1.51 | 3–8 |
| E velocity (m/s) | 1.6 ± 0.19 | 1.4 ± 0.28 | 1.3 ± 0.32 | 1.5 ± 0.25 | 0.9–1.8 |
| TVI TVP (cm) | 49 ± 8.7 | 50 ± 16.3 | 41 ± 2.5 | 47 ± 8.8 | 38–64 |
| TVI TVP /TVI LVOT | 2.3 ± 0.36 | 2.9 ± 0.48 | 1.8 ± 0.12 | 2.3 ± 0.49 | 1.6–3.2 |
| EOA (cm 2 ) | |||||
| CON | 1.40 ± 0.21 | 1.40 ± 0.59 | 2.11 ± 0.23 | 1.59 ± 0.42 | 0.98–2.36 |
| PHT ( c = 190) | NR | NR | NR | NR | NR |
| PHT ( c = 220) | NR | NR | NR | NR | NR |
| IEOA (cm 2 /m 2 ) | |||||
| CON | 0.77 ± 0.19 | 0.71 ± 0.24 | 1.01 ± 0.22 | 0.83 ± 0.22 | 0.54–1.25 |
| PHT ( c = 190) | NR | NR | NR | NR | NR |
| PHT ( c = 220) | NR | NR | NR | NR | NR |
| PPI CON | 0.23 ± 0.03 | 0.20 ± 0.08 | 0.26 ± 0.03 | 0.23 ± 0.04 | 0.14–0.29 |
∗ Obtained by visual estimate ( n = 7 [64%]), M-mode measurement ( n = 3 [27%]), or two-dimensional measurement ( n = 1 [9%]).
† Values are the means of 5 cardiac cycles for all Doppler measurements and calculations using Doppler measurements.
Doppler Data
Complete Doppler hemodynamic data were available for only 76 of the 285 patients (27%) because rounded Doppler diastolic profiles ( Figure 1 ) precluded PHT measurements for the other 209 patients. Excluding PHT, all 285 patients had otherwise complete hemodynamic data. One hundred fourteen (40%) patients had trivial or mild tricuspid transprosthetic or periprosthetic regurgitation that was apparent during TTE.
Doppler data were derived by averaging the values from measurements of five and nine consecutive cardiac cycles. Although the minimal and maximal values for each parameter varied considerably with respiration and beat-to-beat differences within the nine consecutive cycles, no clinically significant difference was observed in values for any hemodynamic parameters averaged over five or nine cycles. Therefore, in accordance with recently published guidelines for echocardiographic assessment of tricuspid valve prostheses, results averaged from five cycles were used to compare hemodynamic variables of different valve sizes.
The mean MG for each bioprosthesis type was as follows: 5.5 mm Hg (range, 2–10 mm Hg) for the CED bioprosthesis, 5.1 mm Hg (range, 2–9 mm Hg) for the MM bioprosthesis, 4.3 mm Hg (range, 2–7 mm Hg) for the SJMB bioprosthesis, 3.5 mm Hg (range, 1–5 mm Hg) for the CEP bioprosthesis, and 5.6 mm Hg (range, 3–8 mm Hg) for the HKII bioprosthesis ( Tables 1–5 ). The threshold values for MG suggestive of abnormal bioprosthesis function were 9.2 mm Hg for the CED bioprosthesis, 8.2 mm Hg for the MM bioprosthesis, 7.0 mm Hg for the SJMB bioprosthesis, 6.2 mm Hg for the CEP bioprosthesis, and 8.6 mm Hg for the HKII bioprosthesis. The threshold value for all five bioprosthesis types combined was 8.8 mm Hg ( Table 6 ). Two hundred sixty-nine (94%) of the 285 patients had MGs < 8.8 mm Hg.
| Type of prosthesis | MG (mm Hg) | E velocity (m/s) | TVI TVP (cm) | TVI TVP /TVI LVOT | PHT (m/sec) |
|---|---|---|---|---|---|
| Carpentier-Edwards Duraflex | |||||
| All patients ( n = 177) | 9.2 | 2.1 | 67 | 3.4 | 185 |
| Patients with IEOA ≤ 0.9 cm 2 /m 2 ( n = 108) | 9.3 | 2.2 | 68 | 3.6 | 196 |
| Patients with IEOA > 0.9 cm 2 /m 2 ( n = 69) | 8.4 | 2.0 | 59 | 2.8 | 175 |
| Medtronic Mosaic | |||||
| All patients ( n = 49) | 8.2 | 1.9 | 63 | 3.3 | 211 |
| Patients with IEOA ≤ 0.9 cm 2 /m 2 ( n = 20) | 8.5 | 2.0 | 66 | 3.3 | 187 |
| Patients with IEOA > 0.9 cm 2 /m 2 ( n = 29) | 7.3 | 1.9 | 56 | 3.0 | 218 |
| St. Jude Medical Biocor | |||||
| All patients ( n = 36) | 7.0 | 2.0 | 63 | 3.1 | 209 |
| Patients with IEOA ≤ 0.9 cm 2 /m 2 ( n = 11) | 7.7 | 1.9 | 63 | 3.7 | 218 |
| Patients with IEOA > 0.9 cm 2 /m 2 ( n = 25) | 6.8 | 2.0 | 61 | 2.7 | 196 |
| Carpentier-Edwards Perimount | |||||
| All patients ( n = 12) | 6.2 | 1.8 | 52 | 2.4 | 180 |
| Patients with IEOA ≤ 0.9 cm 2 /m 2 ( n = 2) | 5.9 | 2.1 | 37 | 3.0 | NR |
| Patients with IEOA > 0.9 cm 2 /m 2 ( n = 10) | 6.4 | 1.8 | 54 | 2.2 | 180 |
| Medtronic Hancock II | |||||
| All patients ( n = 11) | 8.6 | 2.0 | 65 | 3.3 | NR |
| Patients with IEOA ≤ 0.9 cm 2 /m 2 ( n = 7) | 9.3 | 2.1 | 70 | 3.4 | NR |
| Patients with IEOA > 0.9 cm 2 /m 2 ( n = 4) | 6.8 | 1.9 | 48 | 2.1 | NR |
| All prostheses | |||||
| All patients ( n = 285) | 8.8 | 2.1 | 66 | 3.3 | 193 |
| Patients with IEOA ≤ 0.9 cm 2 /m 2 ( n = 147) | 9.2 | 2.1 | 67 | 3.5 | 202 |
| Patients with IEOA > 0.9 cm 2 /m 2 ( n = 138) | 7.8 | 2.0 | 59 | 2.8 | 186 |
The calculated E velocity threshold values (mean + 2 standard deviations [SDs]) for detecting possible prosthesis dysfunction were 2.1 m/sec for the CED bioprosthesis, 1.9 m/sec for the MM bioprosthesis, 2.0 m/sec for the SJMB bioprosthesis, 1.8 m/sec for the CEP bioprosthesis, and 2.0 m/sec for the HKII bioprosthesis. Nearly all (278 [98%]) of the 285 patients had E velocities below these threshold values. The calculated threshold value for all five bioprosthesis types combined was 2.1 m/sec ( Table 6 ). Two hundred eighty (98%) of the 285 bioprostheses had E velocities <2.1 m/sec.
The mean TVI TVP was <45 cm for all five bioprosthesis types combined. The calculated threshold values indicating possible bioprosthesis dysfunction were 67 cm for the CED bioprosthesis, 63 cm for the MM bioprosthesis, 63 cm for the SJMB bioprosthesis, 52 cm for the CEP bioprosthesis, 65 cm for the HKII bioprosthesis, and 66 for all five bioprostheses combined ( Table 6 ). Two hundred eighty (98%) of the 285 bioprostheses had TVI TVP values < 66 cm.
The calculated threshold values for TVI ratio predictive of abnormal bioprosthesis function were 3.4 for the CED bioprosthesis, 3.3 for the MM bioprosthesis, 3.1 for the SJMB bioprosthesis, 2.4 for the CEP bioprosthesis, and 3.3 for the HKII bioprosthesis. The threshold value for all five bioprosthesis types combined was 3.3 ( Table 6 ). Two hundred seventy-four of the 285 patients (96%) had TVI ratios < 3.3.
The mean PHT varied among the five bioprosthesis types (101–132 msec). PHT was <200 msec for all 76 patients for whom it could be measured. PHT could not be measured in any of the 11 HKII patients, due to rounded Doppler signals. The threshold values for PHT indicating probable bioprosthesis dysfunction were 185 msec for the CED bioprosthesis, 211 msec for the MM bioprosthesis, 209 msec for the SJMB bioprosthesis, 180 msec for the CEP bioprosthesis, and 193 msec for all 76 patients combined ( Table 6 ).
The mean EOA calculated using the continuity equation was 1.60, 1.81, 1.88, 2.02, and 1.59 cm 2 for the CED, MM, SJMB, CEP, and HKII tricuspid valve bioprostheses, respectively ( Tables 1–5 ). Mean EOA and IEOA were significantly lower when calculated by the continuity equation than by the 220/PHT formula ( P < .001) for the five bioprosthesis types combined. With the 190/PHT formula, mean IEOA calculated by the continuity equation was also significantly lower ( P < .04), but mean EOA was not.
PPI
PPI, the ratio of the tricuspid valve bioprosthesis to the geometric orifice area, is a measure of how much of the primary geometric orifice area is used for flow. The PPI is useful for evaluating the efficiency of flow when comparing various prosthesis designs. In the current study, the mean PPI was 0.23, 0.30, 0.26, 0.30, and 0.23 for the CED, MM, SJMB, CEP, and HKII tricuspid valve bioprostheses, respectively ( Tables 1–5 ). There was no significant association between PPI and valve size.
Effect of Bioprosthesis Size
Valve sizes were 25 mm in one of the 285 patients (<1%), 27 mm in 17 patients (6%), 29 mm in 34 patients (12%), 31 mm in 78 patients (27%), 33 mm in 91 patients (32%), and 35 mm in 64 patients (22%). Clinical and hemodynamic variables among valve sizes were compared for the CED tricuspid valve bioprosthesis, but because of the small number of bioprostheses in each of the other valve type groups, comparison by size was not possible. No significant differences were observed among the various CED bioprosthesis valve sizes with respect to body surface area (BSA), mean MG, E velocity, TVI TVP , TVI ratio, EOA, and IEOA ( Figure 2 ) or any other parameters. Values for these variables for the MM, SJMB, CEP, and HKII tricuspid valve bioprostheses are illustrated in Figures 3 to 6 .
