Transcatheter aortic valve implantation in small surgical aortic prosthesis for small body size patients.

Transcatheter aortic valve replacement valve-in-valve: Future implications for the surgeon

Self-Expanding Versus Balloon-Expandable Valve: Are We at the Cusp of Delivering a Perfect Transcatheter Aortic Valve?

Introduction: Surgical aortic valve replacement (SAVR) in a small aortic root is still challenging with regard to the surgical technique and prosthesis size selection, which often causes patient-prosthesis mismatch (PPM). On the other hand, because a prosthetic valve of transcatheter aortic valve replacement (TAVR) is tightly implanted inside a native valve, larger effective orifice area (EOA) may be gained. The aim of this study is to prove that hemodynamic performance after TAVR is superior to that after SAVR. Methods: 160 patients, who underwent SAVR (n=36; age 75.1±5.6 years) and TAVR (n=124; age 82.4±6.8 years) for aortic valve stenosis, were enrolled. Preoperative ECG-gated multi-slice CT (MSCT) and echocardiography immediately before a discharge were performed in all patients. PPM was defined as the effective orifice area index ≤0.85cm2/m2 and we compared and examined hemodynamic performance after TAVR and SAVR. Results: Although the mean body size was significantly smaller (p<.05) in TAVR than that in SAVR (1.44±0.15 vs 1.51±0.20 m2), there were no significant differences in the diameters of annulus (23.2±1.6 vs 23.3±2.8 mm), valsalva sinus (29.8±2.6 vs 29.9±4.4 mm), and ST junction (25.2±2.8 vs 24.8±3.5 mm) on preoperative MSCT findings. Postoperative echocardiography revealed significantly less Vmax (2.2±0.4 vs 2.5±0.5 m/s, p<.0001), less mean pressure gradient (10.1±3.6 vs 14.5±5.0 mmHg, p<.0001), and larger EOA (1.62±0.29 vs 1.45±0.36 cm2, p<.005) in TAVR compared to SAVR, respectively. Consequently, PPM was more frequently in SAVR compared to TAVR (33.3 vs 8.9%; p<.0007). In multivariate analysis in SAVR identified small ST junction with only predictive factor of PPM (odds ratio [OR], 2.08; 95% CI, 1.23-4.36; p<.005; area under the receiver-operating characteristic curve [AUC], 0.84). On the other hand, regarding TAVR, large BSA was only predictive factor of PPM (p<.05). Conclusions: The hemodynamic performance of transcatheter prosthetic valve is superior to that of surgical prosthetic valve in a patient with small aortic root, in particular, small ST junction. TAVR should be considered in patients with anticipated PPM if the surgical risk is similar to TAVR.

Commentary: When you wish upon a valve…

Prosthesis-patient mismatch (PPM) after surgical aortic valve replacement (SAVR) for severe aortic valve stenosis (AVS) is common, but less common after transcatheter aortic valve replacement (TAVR) in patients considered at high risk for death after surgery. The objectives of this study were to determine incidence and clinical effect of PPM after SAVR and TAVR in a primarily low-risk patient group. Patients 70 years or older with severe isolated AVS, regardless of predicted operative mortality risk, were consecutively randomized 1:1 to TAVR using a self-expandable bioprosthesis (n = 145) or SAVR (n = 135). Post-procedure PPM was graded after 3 months as follows: Not present-mild, if indexed effective orifice area (iEOA) >0.85 cm2/m2, moderate, if 0.65 cm2/m2 < iEOA ≤ 0.85 cm2/m2 and severe, if iEOA ≤0.65 cm2/m2. Outcomes were major adverse cardiac and cerebrovascular events (MACCE, e.g. composite rate of all-cause death, stroke, myocardial infarction or valve reintervention), cardiac-related hospitalizations and New York Heart Association (NYHA) functional class after 2 years. The incidence and the severity of PPM were significantly lower after TAVR compared with SAVR (severe, moderate, none-mild 14.0, 35.5, 50.4 vs 33.9, 36.7, 29.4%; P<0.001). PPM resulted in similar higher mean valve gradients at 3 months for both groups. Baseline characteristics related to severe PPM were younger age, absence of diabetes mellitus, lower mortality-risk score for TAVR, and younger age and higher body mass index for SAVR. At 2 years, there were numerical but no statistically significant differences between both TAVR and SAVR patients with severe and no severe PPM for MACCE (0.0 vs 12.8% for TAVR; P = 0.13, and 13.5 vs 7.0% for SAVR; P = 0.27), number of cardiac-related hospitalizations (mean ± standard deviation 0.4 ± 0.6 vs 0.6 ± 0.8; P = 0.23, and 0.4 ± 0.8 vs 0.5 ± 0.9; P = 0.70) and NYHA functional class (Class I/II/III/IV: 64.7/29.4/5.9/0.0 vs 62.1/34.7/3.2/0.0%, respectively; P = 0.91, and 71.4/25.7/2.9/0.0 vs 72.9/22.9/4.3/0.0%, respectively; P = 0.92). The incidence of PPM was lower and less severe after TAVR compared with SAVR in intermediate- and low-risk patients with severe AVS. There were no significant differences in MACCE, cardiac-related hospitalizations or NYHA class after 2 years for patients with versus those without severe PPM.

Comparison of Transcatheter and Surgical Aortic Valve Replacement in Severe Aortic Stenosis: A Longitudinal Study of Echocardiography Parameters in Cohort A of the PARTNER Trial (Placement of Aortic Transcatheter Valves)

Robotic aortic valve replacement

The following are highlights from the new series, Circulation: Cardiovascular Quality and Outcomes Topic Reviews. This series will summarize the most important manuscripts, as selected by the Editor, which have been published in the Circulation portfolio. The objective of this new series is to provide our readership with a timely, comprehensive selection of important papers that are relevant to the quality and outcomes as well as general cardiology audience. The studies included in this article represent the most significant research in the area of valvular heart disease. ( Circ Cardiovasc Quality and Outcomes . 2012;5:-e103.) In recent years, no field of clinical cardiology has experienced a great influx of transformational therapeutic options as has the area of valvular heart disease. Treatment of severe aortic stenosis (AS) has been revolutionized by transcatheter aortic valve replacement (TAVR), which has been shown to improve life expectancy and functional outcomes in patients with inoperable AS1,2 and to have short-term outcomes comparable to surgical aortic valve replacement (AVR) in patients at high perioperative risk.3,4 Analogously, mitral valve disease has been amenable to percutaneous valve replacement,5,6 as well as clipping procedures7 that can substantively reduce severe mitral regurgitation (MR) and improve functional outcomes. Even right-sided heart disease involving valves in pulmonary8,9 and tricuspid10 positions has been treated successfully with endovascular techniques. Yet, even with this growing focus on percutaneous valvular interventions, open surgical techniques remain the dominant treatment strategies and standard of care for most advanced lesions. Surgical valve repair and replacement account for 10% to 20% of all cardiac surgical procedures,11–13 approximately two thirds of which are for AS.11–13 For patients undergoing surgery, there remains considerable debate about risk stratification,14 intraoperative technique,15 and postoperative …

Limited data is available about the effect of implanted valve size on prosthesis-patient mismatch (PPM) incidence and aortic gradient (AG) after transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). We compared PPM incidence and postprocedural AG between TAVR and SAVR patients considering the impact of implanted valve size. From March 20, 2012, to September 30, 2015, 563 consecutive patients underwent TAVR (n = 419) or isolated SAVR (n = 144). Postprocedural transthoracic echocardiography was obtained within 30 days; AG, effective orifice area (EOA), and EOA index were calculated. A total of 381 patients in TAVR group and 82 patients in SAVR group were included. Mean preoperative AG and mean aortic valve area were not significantly different between the 2 groups. Postprocedural AG was significantly lower in TAVR than SAVR group, 7.74 ± 5.39 versus 14.27 ± 8.16 (P < 0.001). Between patients who had TAVR and SAVR with a valve size ≤23 mm, SAVR patients were 3 times more likely to have greater than mild AG after the procedure, OR: 3.1 (95% CI, 1.1 to 8.9) (P < 0.001). PPM incidence was significantly higher in SAVR group than TAVR group, 44 (53.7%) versus 112 (29.4%), OR = 2.8 (95% CI, 1.7 to 4.5) (P < 0.001). The PPM incidence was also higher in SAVR group than TAVR group among those who had the procedures with a valve size ≤23 mm, 35 (64.8%) versus 56 (47.9%), OR = 2 (95% CI, 1.1 to 3.9) (P = 0.048). Postprocedural outcomes were comparable between the 2 groups. In comparison to SAVR, TAVR is associated with less PPM and lower AG, especially in patients receiving a valve size ≤23 mm.

Invited Commentary

Commentary: Age is just an element of the quality of life puzzle following aortic valve replacement

The CoreValve US High-Risk Clinical Study compared clinical outcomes and serial echocardiographic findings in patients with severe aortic valve stenosis after transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis or surgical aortic valve replacement (SAVR). Eligible patients were randomly assigned 1:1 to TAVR with a self-expanding bioprosthesis or SAVR (N=747). Echocardiograms were obtained at baseline, discharge, 30 days, 6 months, and 1 year after the procedure and were analyzed at a central core laboratory. Compared with SAVR patients (N=357), TAVR patients (N=390) had a lower mean aortic valve gradient, larger valve area, and less patient-prosthesis mismatch (all P<0.001), but more paravalvular regurgitation at discharge, which decreased at 1 year. SAVR patients experienced significant right ventricular systolic dysfunction at discharge and 1 month with normal right ventricular function at 1 year. One-year all-cause mortality was 14.2% for TAVR and 19.1% for SAVR patients. Preimplantation aortic regurgitation ≥mild was associated with reduced mortality hazard for both the TAVR (hazard ratio 0.48, 95% confidence interval 0.27-0.85; P=0.01) and the SAVR groups (hazard ratio 0.53, 95% confidence interval 0.32-0.87; P=0.01). Aortic regurgitation ≥mild after TAVR was associated with increased risk for all-cause mortality (hazard ratio 1.95, 95% confidence interval 1.08-3.53; P=0.03). In patients with severe aortic stenosis at increased surgical risk, TAVR was associated with better systolic valve performance, similar left ventricular remodeling, more paravalvular regurgitation, and less right ventricular systolic dysfunction compared with SAVR. Despite an overall mortality reduction for the TAVR group, ≥mild aortic valve regurgitation after TAVR was associated with an increased mortality hazard. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01240902.

Introduction Both surgical and transcatheter aortic valve replacement are effective interventions for treatment of patients with severe aortic stenosis. Data from landmark randomized trials have shown comparable improvement in aortic valve hemodynamics and left ventricular remodeling. Whether similar patterns will be observed in real-world practice has not been completely investigated. Purpose To compare the impact of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) on short- and intermediate-term changes in aortic valve hemodynamics and left ventricular reverse-remodeling. Methods A total of 213 patients with severe AS were referred for TAVR (n=137) or SAVR (n=76) at a single center (August/ 2015-Feb/ 2021). Patient demographics and echocardiographic parameters of aortic valve stenosis severity were collected retrospectively. Changes over-time in aortic valve area, mean gradient, dimensionless index, left ventricular ejection fraction (EF), and ventricular septal thickness were examined using linear mixed models. Results Patients undergoing TAVR were older with higher STS risk scores and a greater burden of comorbidities (Table). Over a median follow-up of 13 months (IQR 4–31), both groups experienced a significant reduction in aortic valve mean gradient (25.7 mmHg with TAVR and 18.8 mmHg with SAVR), with no significant between-group difference (P=0.15). Aortic valve dimensionless index significantly increased in TAVR and SAVR groups (0.23 and 0.13, respectively) and was more pronounced in the TAVR group (P=0.01). Similarly, aortic valve area increased significantly in both groups (0.66 cm2 and 0.42 cm2, respectively) without a significant across-group difference (P=0.07). On the other hand, left ventricular ejection fraction did not change significantly over time (−0.61 and 1.15 EF points, respectively) with no significant between-group difference at 12 months (P=0.06). Ventricular septal thickness was significantly reduced in both groups, with no significant between group difference (P=0.4; Figure). Conclusion In this real-world experience, both TAVR and SAVR were associated with significant improvement in aortic valve hemodynamic parameters and modest reverse left ventricular remodeling. Furthermore, these changes were comparable with both modalities, adding to available evidence from randomized clinical trials on beneficial effects of both TAVR and SAVR. Funding Acknowledgement Type of funding sources: None. Table 1Figure 1

Severe prosthesis-patient mismatch (PPM) is diagnosed by an indexed effective orifice area <0.65 cm2/m2, which is derived from stroke volume index. We examined the impact of flow, determined by stroke volume index, on severe PPM following transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). We included SAVR patients from the PARTNER 2A trial (Placement of Aortic Transcatheter Valve 2A) and TAVR patients from the PARTNER 2 S3i (Placement of Aortic Transcatheter Valve 2 S3i) registry. The primary end point was the separate analysis of all-cause death, cardiac death, and rehospitalization at 5 years. Following TAVR and SAVR, we compared the primary end points between severe versus no-severe PPM in all patients, in low flow (LF), and in normal flow. Multivariable analysis was performed to determine variables associated with the end points. Nine hundred fifty-four TAVR and 726 SAVR patients with PPM and flow data were included. Severe PPM following TAVR was significantly lower compared with SAVR in all patients (9% versus 28%, P<0.0001), in normal flow (5% versus 8%, P=0.04), and in LF (20% versus 42%, P<0.0001). Severe PPM was associated with rehospitalization following TAVR (odds ratio, 1.52 [95% CI, 1.01-2.29], P=0.0456) and SAVR (odds ratio, 1.51 [95% CI, 1.06-2.16], P=0.0237). Severe PPM in LF was independently associated with cardiac death following TAVR (odds ratio, 1.85 [95% CI, 1.06-3.23], P=0.0308). Following SAVR, severe PPM in LF and low ejection fraction was associated with increased cardiac death (35.26% versus 12.51%, P=0.01) and rehospitalization (37.59% versus 15.46%, P=0.006) compared with severe PPM in LF and preserved ejection fraction, respectively. Severe PPM in normal flow was not associated with clinical outcomes despite higher gradients and smaller valves compared with severe PPM in LF. Severe PPM is more common following SAVR compared with TAVR. Regardless of the implanted valve size or gradient, severe PPM impacts mortality only in patients with LF following TAVR and LF and low ejection fraction following SAVR. Severe PPM in normal flow is not associated with poor outcomes. Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01314313 and NCT02687035.

Determine the comparative impact of small prosthesis size on transcatheter and surgical aortic valve replacement (SAVR) outcomes. Patients with small aortic annuli tend to have worse postoperative outcomes and hemodynamics. We sought to describe surgical outcomes in patients with very small aortic annuli and then compare early hemodynamic and clinical outcomes in patients undergoing surgical or transcatheter aortic valve replacement (TAVR) with the smallest available valves to assist in optimal prosthesis selection for this challenging patient population. A retrospective single-center study comparing patient data from 2143 patients undergoing SAVR with valves having a true internal diameter (ID) of ≥19 mm with 130 patients receiving surgical valves with true ID's <19 mm (SmSAVR). Outcomes of SmSAVR patients were then compared with 40 patients undergoing TAVR receiving small valves (SmTAVR). A representative SmSAVR cohort was then compared with the SmTAVR patients for post-operative hemodynamics. Receiving a small surgical valve may significantly increase 1-year mortality compared with standard-sized surgical valves (HR 1.93; 95% confidence interval 1.03-3.61). SmTAVR patients had significantly shorter lengths of stay than SmSAVR (median 5 vs. 9 days), and significantly better postoperative hemodynamic profiles (mean gradient 13.4 ± 7.8 vs. 18.1 ± 8.4 mm Hg, P = 0.006, peak velocity of 2.5 ± 0.6 vs. 2.9 ± 0.6 m/s, P = 0.003). TAVR is a safe and reasonable option for patients with small aortic annuli and is associated with shorter hospital stays and more favorable postoperative hemodynamic outcomes compared with SAVR. © 2017 Wiley Periodicals, Inc.