Predictors Of Structural Valve Deterioration Research Articles

Structural Valve Deterioration After Self-Expanding Transcatheter or Surgical Aortic Valve Implantation in Patients at Intermediate or High Risk

The frequency and clinical importance of structural valve deterioration (SVD) in patients undergoing self-expanding transcatheter aortic valve implantation (TAVI) or surgery is poorly understood. To evaluate the 5-year incidence, clinical outcomes, and predictors of hemodynamic SVD in patients undergoing self-expanding TAVI or surgery. This post hoc analysis pooled data from the CoreValve US High Risk Pivotal (n = 615) and SURTAVI (n = 1484) randomized clinical trials (RCTs); it was supplemented by the CoreValve Extreme Risk Pivotal trial (n = 485) and CoreValve Continued Access Study (n = 2178). Patients with severe aortic valve stenosis deemed to be at intermediate or increased risk of 30-day surgical mortality were included. Data were collected from December 2010 to June 2016, and data were analyzed from December 2021 to October 2022. Patients were randomized to self-expanding TAVI or surgery in the RCTs or underwent self-expanding TAVI for clinical indications in the nonrandomized studies. The primary end point was the incidence of SVD through 5 years (from the RCTs). Factors associated with SVD and its association with clinical outcomes were evaluated for the pooled RCT and non-RCT population. SVD was defined as (1) an increase in mean gradient of 10 mm Hg or greater from discharge or at 30 days to last echocardiography with a final mean gradient of 20 mm Hg or greater or (2) new-onset moderate or severe intraprosthetic aortic regurgitation or an increase of 1 grade or more. Of 4762 included patients, 2605 (54.7%) were male, and the mean (SD) age was 82.1 (7.4) years. A total of 2099 RCT patients, including 1128 who received TAVI and 971 who received surgery, and 2663 non-RCT patients who received TAVI were included. The cumulative incidence of SVD treating death as a competing risk was lower in patients undergoing TAVI than surgery (TAVI, 2.20%; surgery, 4.38%; hazard ratio [HR], 0.46; 95% CI, 0.27-0.78; P = .004). This lower risk was most pronounced in patients with smaller annuli (23 mm diameter or smaller; TAVI, 1.32%; surgery, 5.84%; HR, 0.21; 95% CI, 0.06-0.73; P = .02). SVD was associated with increased 5-year all-cause mortality (HR, 2.03; 95% CI, 1.46-2.82; P < .001), cardiovascular mortality (HR, 1.86; 95% CI, 1.20-2.90; P = .006), and valve disease or worsening heart failure hospitalizations (HR, 2.17; 95% CI, 1.23-3.84; P = .008). Predictors of SVD were developed from multivariate analysis. This study found a lower rate of SVD in patients undergoing self-expanding TAVI vs surgery at 5 years. Doppler echocardiography was a valuable tool to detect SVD, which was associated with worse clinical outcomes. ClinicalTrials.gov Identifiers: NCT01240902, NCT01586910, and NCT01531374.

Abstract 9429: The Impact of Hypo-Attenuated Leaflet Thickening on Valvular Haemodynamics and Structural Valve Deterioration Following Transcatheter Aortic Valve Replacement

Introduction: Hypo-attenuated leaflet thickening (HALT) has been described following transcatheter aortic valve replacement (TAVR). It is unclear if HALT impacts prosthetic haemodynamics or predicts structural valve deterioration (SVD). Hypothesis: HALT predicts SVD. Methods: We prospectively evaluated 186 patients who had undergone TAVR with 320-slice CT imaging for the presence of HALT, defined as hypo-attenuation of bioprosthetic leaflets. HALT depth (thickness) was the greatest depth in the sagittal view and HALT area was the greatest area in the axial view. SVD was defined as at least one of mean gradient ≥20 mmHg, increase in gradient ≥10 mmHg from baseline and at least moderate valvular regurgitation. Echocardiograms at discharge, one month and annually were assessed by cardiologists blinded to HALT status. Results: LT prevalence was 17.7% at a median CT scan of 6 weeks (IQR 4-12). SVD occurred in 8.6% at a median follow-up of 2 years (IQR 1-3); two required valve re-intervention, five required anticoagulation that reversed moderate-severe gradient and nine had mild-moderate gradient that were closely monitored. Patients with HALT were more likely to develop SVD (39.3% vs 1.9%, p&lt;0.01), repeat valve replacement (6.1% vs 0%, p = 0.03) and higher valvular gradients throughout follow-up (up to 3-years). HALT affected 1 leaflet in 17 cases, 2 leaflets in 13 cases and 3 leaflets in 3 cases. Patients with HALT had a median cumulative thickness of 2.9 mm (IQR 1.9-4.7) and a median area of 64.2 mm2(IQR 40.9-91.6). Threshold for the occurrence of SVD with HALT characteristics were cumulative depth of 2.4 mm (Spec. 94.1%, Sens. 75.0%, AUC=0.87) and cumulative area of 28 mm2 (Spec. 92.2%, Sens. 81.3%, AUC=0.86). Conclusions: HALT was associated with SVD, repeat valve intervention and higher valvular gradients following TAVR. HALT depth and area were strong predictors of SVD. CT following TAVR may determine patients at-risk of SVD.

Hypo-attenuated leaflet thickening is associated with structural valve deterioration following transcatheter aortic valve replacement

Abstract Background While hypo-attenuated leaflet thickening (HALT) has been extensively described following transcatheter aortic valve replacement (TAVR), it remains unclear if HALT impacts long-term prosthetic haemodynamics or predicts structural valve deterioration (SVD). Purpose To determine the role of HALT and its characteristics of depth and thickness in predicting SVD. Methods We prospectively evaluated 186 patients who had undergone TAVR with 320-slice CT imaging for the presence of HALT, defined as hypo-attenuation of bioprosthetic leaflets in diastole. All assessments were performed by two blinded operators on the 3Mensio workstation. HALT depth (thickness) was the greatest depth in the sagittal view and HALT area was the greatest area in the axial view. SVD was defined as at least one of mean gradient ≥20 mmHg, increase in gradient ≥10 mmHg from baseline and at least moderate valvular regurgitation. Echocardiograms at discharge, one month and annually were assessed by cardiologists blinded to HALT status. Results LT prevalence was 17.7% at a median CT scan of 6 weeks. SVD occurred in 8.6% at a median follow-up of 2 years (IQR 1–3); two required valve re-intervention, five required anticoagulation that reversed moderate-severe gradient and nine had mild-moderate gradients that were closely monitored. Patients with HALT were more likely to develop SVD (39.3% vs 1.9%, p&amp;lt;0.01) and higher trans-valvular gradients throughout follow-up at up to 3-year follow-up. HALT affected one leaflet in 17 cases, two leaflets in 13 cases and three leaflets in 3 cases. Patients with HALT had a median cumulative thickness of 2.9 mm (IQR 1.9–4.7) and a median area of 64.2 mm2 (IQR 40.9–91.6). Threshold for the occurrence of SVD with HALT characteristics were cumulative depth of 2.4 mm (Specificity 94.1%, Sensitivity 75.0%, AUC=0.87) and cumulative area of 28 mm2 (Specificity 92.2%, Sensitivity 81.3%, AUC=0.86). Conclusion HALT was associated with SVD and higher trans-valvular gradients following TAVR. HALT depth and area were strong predictors of SVD. CT following TAVR may determine patients at-risk of SVD. Funding Acknowledgement Type of funding sources: Foundation. Main funding source(s): National Heart Foundation AustraliaNational Health and Medical Research Council Australia

Computed tomography for the prediction of structural valve deterioration in patients undergoing transcatheter aortic valve implantation

Abstract Funding Acknowledgements Type of funding sources: None. Background Computed tomography (CT) provides excellent anatomy assessment of the aortic annulus (AoA) and is currently routinely utilized for pre-procedural planning of transcatheter aortic valve implantation (TAVI). This study sought to investigate if geometrical characteristics of the AoA determined by CT may represent predictors of structural valve deterioration (SVD) in patients undergoing transcatheter aortic implantation (TAVI) with balloon-expandable valves. Methods AoA maximum diameter (Dmax), minimum diameter (Dmin), and area were assessed using pre-procedural CT in patients undergoing TAVI in our Institution. SVD was identified with transthoracic echocardiography at 5.9 ± 1.7 follow-up years. Results 124 consecutive patients (mean age: 79 ± 7 years old; female: 61%) were retrospectively enrolled. AoA Dmax, Dmin and area were significantly smaller in patients with SVD compared to patients without SVD (27.1 ± 2.8 mm vs 25.6 ± 2.2 mm, p = 0.012; 21.8 ± 2.1 mm vs 20.5 ± 2.1 mm, p = 0.001 and 467 ± 88 mm2 vs 419 ± 77 mm2 p = 0.002 respectively). At univariate analysis, female sex, body surface area, the use of a -23 mm prosthetic valve a Dmax &amp;lt;27.1 mm and a Dmin &amp;lt; 19.9 mm were all variables independently associated with SVD whereas at multivariate analysis, only Dmin &amp;lt;19.9 mm (OR = 2.873, 95% CI: 1.191-6.929, p = 0.019) and female sex (OR = 2.659, 95% CI: 1.095-6.458, p = 0.031) were independent predictors of SVD. Conclusions Female sex and AoA Dmin &amp;lt; 19.9 mm are associated to SVD in patients undergoing TAVI with balloon explandable valves. Abstract Figure.

Incidence and Predictors of Structural Valve Deterioration after Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis.

Background Transcatheter aortic valve replacement (TAVR), widely used as an alternative therapy in patients with severe aortic stenosis, is expected to be offered to low-risk patents with a longer life expectancy. The durability of transcatheter aortic valve is becoming of increasing importance. Method PubMed, Embase, and Cochrane CENTRAL from the inception to March 2020 were systematically screened for studies reporting on structural valve deterioration (SVD) in TAVR patients. Incidence of SVD was diagnosed according to the latest European consensus as the primary end point. Predictors of SVD evaluated at multivariable analysis and cumulative incidence function (CIF) of SVD were the secondary end point. Result Twelve studies encompassing 10031 patients evaluating the incidence of SVD were included, with a follow-up between 1 and 8 years. The pooled incidence of SVD was 4.93% (95% CI, 2.75%–7.70%, I2 = 96%) at 1 year and 8.97% (95% CI, 6.89%–11.29%, I2 = 86%) in the long term (≥5 years). Subgroup analysis was performed to identify the valve type that may result in partial heterogeneity. SVD was more frequent in patents with a valve diameter of <26 mm (HR: 3.57, 1.47–8.69), oral anticoagulants (OAC), exposure at discharge (OR: 0.48, 0.38–0.61), or by a disease of renal dysfunction (OR 1.42, 1.03–1.96). Conclusion SVD represents infrequent events after TAVR in the long term (>5 years), occurring more commonly in renal dysfunction patients, with small valve diameter and without OAC exposure. There may be an underestimation of the incidence if we assume death as a competing risk.

P1276EXPLORING POSSIBLE PREDICTORS OF STRUCTURAL DETERIORATION AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION IN HEMODIALYSIS PATIENTS

Abstract Background and Aims Transcatheter aortic valve implantation (TAVI) is an effective treatment for aortic stenosis (AS) in high-risk patients, such as those who are suffering ESRD on hemodialysis. We previously showed that long-term survival of hemodialysis patients underwent TAVI was lower than that of non-hemodialysis patients but was comparable with that of hemodialysis patients treated with surgical aortic valve replacement. It is known that hemodialysis is a high risk of the bioprosthetic structural valve deterioration (SVD) after valve replacement surgery. Consistently, higher incidence of re-TAVI operation due to restenosis was observed in hemodialysis patients than in non-hemodialysis patients (Odds ratio [OR]:29.4, p&amp;lt;0.001). In this study, we aimed to identify predictors of SVD in post-TAVI hemodialysis patients. Method From April 2012 to December 2015, 24 patients on hemodialysis were selected to receive TAVI for the treatment of AS in Osaka University Hospital. Demographic and laboratory data at pre- and post-operation were compared between patients who underwent re-TAVI (valve-in-valve) (SVD group) and those who did not (no-SVD group). Results During the follow-up period (maximal 7 years), 4 out of 24 patients required re-TAVI (valve-in-valve) operation because of SVD. Although serum calcium, phosphate, and PTH levels before operation were comparable between SVD group and no-SVD group, serum magnesium levels were significantly lower in SVD group. Lower serum magnesium quartiles were associated with a higher risk of SVD (OR 5.83, p=0.036). While effective orifice area index (EOAi) of aortic valve at 1 week after TAVI was similar between the 2 groups, EOAi improvement at 1 month was significantly poorer in SVD group than in no-SVD group (1.70 ± 0.15 vs 2.50 ± 0.56, p = 0.049). Conclusion The higher incidence of re-TAVI due to SVD in hemodialysis patients could be related with pre-operative low magnesium levels and with one-month post-operative low EOAi improvement. This was a single center observational study, and the number of patients was very small so that our data would not be necessarily applicable for every patient. Further investigation is necessary for identifying a prognostic predictor of SVD, which will lead to the prevention of unfavorable re-operation in hemodialysis patients.

Younger age and valve oversizing are predictors of structural valve deterioration after pulmonary valve replacement in patients with tetralogy of Fallot

We sought to identify predictors of structural valve deterioration after pulmonary valve replacement in patients with tetralogy of Fallot. A retrospective review of 227 patients with tetralogy of Fallot who underwent stented bioprosthetic pulmonary valve replacement at Children's Hospital Boston between 1994 and 2009 was performed. Patient and valve characteristics were assessed as potential predictors of structural valve deterioration by using univariate and multivariable analysis. Freedom from pulmonary valve reintervention and structural valve deterioration were determined by using Kaplan-Meier analysis. Two hundred twenty-nine pulmonary valve replacement operations were performed, with no early mortalities. Freedom from reintervention and structural valve deterioration were 94% (95% confidence interval, 87%-100%) and 74% (95% confidence interval, 63%-85%) at 5 years, respectively, and median time to reintervention was 6.4 years (range, 2-10.1 years). Younger age and higher indexed valve internal diameter were predictors of reduced time to structural valve deterioration. Among patients aged less than 20 years at the time of pulmonary valve replacement, indexed valve internal diameter was a significant predictor of increased risk of structural valve deterioration. Valve manufacturer was not a significant predictor of structural valve deterioration. Younger age at the time of pulmonary valve replacement and valve oversizing in patients less than 20 years of age at the time of pulmonary valve replacement were significant predictors of structural valve deterioration and could potentially affect the timing of pulmonary valve replacement and the extent of valve oversizing in small children. No statistically significant difference in valve performance was seen between bioprosthetic valve types at short-term follow-up.

Mitral valve disease: if the mitral valve is not reparable/failed repair, is bioprosthesis suitable for replacement?☆

The durability of mitral bioprostheses has long been known to be inferior to aortic bioprostheses. Mitral valve reconstruction/repair is currently recommended for most mitral valve procedures. The choice of prostheses for non-reparable or failed mitral valve repairs has not been specified or given appropriate attention within the literature. The objective of this study is to address the role of bioprostheses in the specific subset of non-reparable or failed repair patients by using the knowledge of the general durability of mitral porcine bioprostheses, inclusive of the Carpentier-Edwards mitral porcine bioprosthesis. The CE-SAV was implanted in 1135 patients (1175 operations) for mitral valve replacement (MVR) from 1982 to 2000. The mean age was 65.0+/-12.1 years (range 13-86 years). The mean follow-up was 6.4+/-4.5 years, 7555.9 patient-years and 98.3% complete. The evaluation considered freedom from structural valve deterioration (SVD) and freedom from composites of complications, as well as risk assessment. For the 51-60 year age group, the actual and actuarial freedom from SVD was, at 18 years, 56.0+/-4.1% and 14.7+/-5.8%; for the 61-70 year age group was, at 18 years, 69.6+/-2.6% and 26.5+/-5.9%, respectively. For the >70 group, at 15 years was 92.2+/-2.0% and 69.0+/-9.7%, respectively. There were a total of 256 SVD events with 31 fatalities and 226 reoperations with 10 fatalities (4.42%). The predictors of SVD were age (hazard ratio [HR] 0.98, p=0.0002), concomitant CAB (HR 0.66, p=0.020) and valve size (HR 1.08, p=0.034). The overall actual freedom, at 15-18 years, for >70 age group was, for valve-related reoperation, 94.3+/-1.5%; and for valve-related mortality was 87.8+/-2.3%. The CE-SAV mitral porcine bioprosthesis cannot be recommended as representative of prosthesis-type of choice for non-reparable or failed repair of native mitral valves for ages </=70 years. The CE-SAV mitral porcine bioprosthesis is satisfactory for implantation >70 years of age. The clinical performance of the CE-SAV is similar to other mitral bioprostheses.

15-Year Comparison of Supra-Annular Porcine and PERIMOUNT Aortic Bioprostheses

The second-generation Carpentier-Edwards bioprostheses, the supra-annular porcine valve and the PERIMOUNT pericardial valve, have been evaluated longitudinally for several years. This study compared clinical performance over 15 years. Aortic valve replacement was performed with a supra-annular porcine valve in 1,823 patients (group 1) aged 19-89 years (mean, 68.9 +/- 10.9 years) and with a PERIMOUNT pericardial bioprosthesis in 1,430 patients (group 2) aged 16-90 years (mean, 69.5 +/- 10.4 years). The groups were similar except for concomitant coronary artery bypass in 43% of group 1 and 18% of group 2 ( p < 0.001). Overall survival at 15 years was 29.3% +/- 1.5% for group 1 and 35.2% +/- 3.1% for group 2 ( p = 0.0009). The actual freedom from valve-related mortality was 88.5% +/- 0.9% for group 1 and 84.9% +/- 1.7% for group 2. The actual freedom from structural valve deterioration at 15 years was similar overall, and for patients aged > 60 years, between the groups, but was dissimilar (group 2 > group 1) for age </= 60 years. The predictors of structural valve deterioration were valve type (group 1 > group 2), sex (male > female), age, and concomitant coronary artery bypass. Both bioprostheses provided satisfactory clinical performance at 15 years after aortic valve replacement.

Fifteen-year clinical experience with the Biocor porcine bioprostheses in the mitral position

Background. Bioprosthetic valve use represents a crucial improvement in surgical treatment of mitral valve disease. The aim of this study is to determine the long-term durability of the Biocor porcine bioprosthetic mitral valve. Methods. Between 1985 and 1989, a total of 158 Biocor porcine bioprosthetic valves were placed in the mitral position, and long-term results of these patients were investigated retrospectively in 1999. Results. Thirty-day mortality was 4.4% (7 patients). Total follow-up was 1,499 patient-years. Actuarial survival was 83.66% ± 3% at 5 years, 77.78% ± 3.36% at 13 years (1.8% patient-year). Multivariate analysis demonstrated younger age, duration of implantation, congestive heart failure, and functional class to be significant predictors of late mortality. Actuarial freedom from valve-related mortality was 98.58% ± 1% at 15 years (0.13% patient-year). Actuarial freedom from structural valve deterioration was 95.49% ± 1.8% at 5 years, 70.2% ± 4.12% at 10 years, and 64.82% ± 5.34% at 13 years (2.6% patient-year). Actuarial freedom from structural valve deterioration-related reoperation was 98.43% ± 1.1% at 5 years, 89.15% ± 2.85% at 10 years, and 76.82% ± 7.91% at 14 years. Multivariate analysis showed younger age and duration of implantation to be significant predictors of structural valve deterioration and its related reoperation. Conclusions. By studying a 15-year time period, it is seen that this new generation porcine bioprosthetic valve should be considered an alternative for mechanical valves in selected patients.

Late results of heart valve replacement with the Hancock II bioprosthesis

Objective: To review the late clinical outcomes of patients who had isolated aortic or mitral valve replacement with the Hancock II bioprosthesis. Methods: From 1982 to 1994, 670 patients underwent isolated aortic valve replacement and 310 underwent isolated mitral valve replacement with the Hancock II bioprosthesis (Medtronic Inc, Minneapolis, Minn). Mean age was 65 ± 12 years in both groups. Most patients were in New York Heart Association functional classes III or IV, and concomitant coronary artery disease was present in 44% of patients in the aortic valve group and 41% of patients in the mitral valve group. Patients were followed up prospectively at periodic intervals. Mean follow-up was 87 ± 45 months in the aortic valve group and 83 ± 50 months in the mitral valve group, and it was 99% complete. Results: Actuarial survival at 15 years was 47% ± 3% in the aortic valve group and 30% ± 5% in the mitral valve group. Older age, advanced functional class, impaired left ventricular function, active endocarditis, and coronary artery disease were independent predictors of late death. The freedom from thromboembolic complications at 15 years was 83% ± 3% in the aortic and 87% ± 3% in the mitral valve group. The freedom from infective endocarditis at 15 years was 96% ± 1% in the aortic and 91% ± 1% in the mitral valve group. At 15 years, the actuarial and actual freedom from structural valve deterioration was 81% ± 5% and 90% ± 3%, respectively, in the aortic group and 66% ± 6% and 83% ± 3%, respectively, in the mitral group. Younger age, mitral valve position, and poor ventricular function were independent predictors of structural valve deterioration. The freedom from repeat valve replacement at 15 years was 77% ± 5% in the aortic group and 69% ± 6% in the mitral. The vast majority of patients had functional improvement after valve replacement. Conclusions: The Hancock II bioprosthesis has provided good clinical outcomes and is a durable valve, particularly in the aortic position in older patients. (J Thorac Cardiovasc Surg 2001;121:268-78)