The use of pledget-reinforced sutures during surgical aortic valve replacement: A systematic review and meta-analysis.

Objective: Literature presents conflicting results on the pros and cons of pledget-reinforced sutures during surgical aortic valve replacement (SAVR). We aimed to investigate the effect of pledget-reinforced sutures versus sutures without pledgets during SAVR on different outcomes in a systematic review and meta-analysis. Methods: A literature search was performed in five different medical literature databases. Studies must include patients undergoing SAVR and must compare any pledget-reinforced with any suturing technique without pledgets. The primary outcome was paravalvular leakage (PVL), and secondary outcomes comprised thromboembolism, endocarditis, mortality, mean pressure gradient (MPG) and effective orifice area (EOA). Results were pooled using a random-effects model as risk ratios (RRs) or mean differences (MDs) for which the no pledgets group served as reference. Results: Nine observational studies met the inclusion criteria. The risk of bias was critical in seven studies, and high and moderate in two other. The pooled RR for moderate or greater PVL was 0.59 (95 % confidence interval [CI] 0.13, 2.73). The pooled RR for mortality at 30-days was 1.02 (95 % CI 0.48, 2.18) and during follow-up was 1.15 (95 % CI 0.67, 2.00). For MPG and EOA at 1-year follow-up, the pooled MDs were 0.60 mmHg (95 % CI -4.92, 6.11) and -0.03 cm2 (95 % CI -0.18, 0.12), respectively. Conclusions: Literature on the use of pledget-reinforced sutures during SAVR is at high risk of bias. Pooled results are inconclusive regarding superiority of either pledget-reinforced sutures or sutures without pledgets. Hence, there is no evidence to support or oppose the use of pledget-reinforced sutures.

A review of polymeric heart valves leaflet geometric configuration and structural optimization.

Valvular heart disease (VHD) is a major cause of loss of physical function, quality of life and longevity, and its prevalence is growing worldwide due to increased survival rates and an aging population. The most common treatment for VHD is surgical heart valve replacement with mechanical heart valves (MHVs) and bioprosthetic heart valves (BHVs), but with different limitations. Polymeric heart valves (PHVs) exhibit promising material properties, valve dynamics and biocompatibility, representing the most feasible alternative to existing artificial heart valves. However, inadequate fatigue performance remains a critical obstacle to their clinical translation. In this case, geometry and material design are essential to obtain the best mechanical properties of the PHV. In this study, we summarized the effects of optimal design of PHVs from geometrical configuration optimization (valve height, thickness and design curve) and structural material optimization (anisotropy, fiber reinforcement, variable thickness, microstructure and asymmetric optimization), and selected the parameters including Effective Orifice Area (EOA), Regurgitant fraction (RF), and Stress Distribution to compare the performance of valves. It would provide the theoretical support for the optimal design of PHVs.

Five-Year Outcomes of Measured and Predicted Prosthesis-Patient Mismatch following Transcatheter Aortic Valve Implantation.

Data on the long-term outcomes of prosthesis patient mismatch (PPM) after transcatheter aortic valve implantation (TAVI) remain controversial. This study aimed to investigate the incidence and clinical outcomes of measured PPM (PPMM) and predicted PPM (PPMP) in patients who underwent TAVI. This is a retrospective analysis of 3,016 patients who underwent TAVI at a large health care system between 2012 and 2021. Effective orifice area indexed to body surface area (EOAi) was measured at discharge using the continuity equation. EOAi was predicted according to the published predictive tables for each model and size of the valve. Primary end point was 5-year survival rate. Mean age was 80 years, and 55.6% were male. The mean Society of Thoracic Surgeons risk score was 4.66%. 74.9% of patients received a balloon-expandable valve (BEV), and 25.1% received a self-expanding valve (SEV). The incidence of severe PPM was markedly lower when defined by predicted versus measured EOAi (0.8% vs 6.3%, p <0.001) and when assessed in SEV versus BEV (5.3% vs 6.6%, p = 0.02). Neither severe PPMp nor severe PPMM was associated with 5-year mortality (hazard ratio 1.26, 95% confidence interval 0.96 to 1.66, p = 0.095; hazard ratio 1.03, 95% confidence interval 0.42 to 2.49, p = 0.954, respectively), irrespective of the presence of high residual pressure gradient. Neither BEV nor SEV was associated with an increased 5-year mortality, irrespective of PPM definition or severity. In this large health care system analysis, neither severe PPMP nor severe PPMM was associated with 5-year all-cause mortality. There was no difference between BEV and SEV in terms of mortality, irrespective of the definition or severity of PPM.

A fluid-structure interaction simulation on the impact of transcatheter micro ventricular assist devices on aortic valves.

BACKGROUND AND OBJECTIVE: The implantation of ventricular assist devices (VADs) has become an important treatment option for patients with heart failure. Aortic valve insufficiency is a common complication caused by VADs implantation. Currently, there is very little quantitative research on the effects of transcatheter micro VADs or the intervention pumps on the aortic valves. METHODS: In this study, the multi-component arbitrary Lagrange-Eulerian method is used to perform fluid-structure interaction simulations of the aortic valve model with and without intervention pumps. The effects of intervention pumps implantation on the opening area of the aortic valves, the stress distribution, and the flow characteristics are quantitatively analyzed. Statistical results are consistent with clinical guidelines and experiments. RESULTS: The implantation of intervention pumps leads to the valve insufficiency and causes weak valve regurgitation. In the short-term treatment, the valve regurgitation is within a controllable range. The distribution and variation of stress on the leaflets are also affected by intervention pumps. The whirling flow in the flow direction affects the closing speed of the aortic valves and optimizes the stress distribution of the valves. In the models with whirling flow, the effects of intervention pumps implantation on valve motion and stress distribution differ from those without whirling flow. However, the valve insufficiency and valve regurgitation caused by intervention pumps still exist in the models with whirling flow. Conventional artificial bioprosthetic valves have limited effectiveness in treating the valve diseases caused by intervention pumps implantation. CONCLUSIONS: This study quantitatively investigates the impact of intervention pumps on the aortic valves, and investigates the effect of blood rotation on the valve behavior, which is a gap in previous research. We suggest that in the short-term treatment, the implantation of intervention pumps has limited impact on aortic valves, caution should be exercised against valve regurgitation issues caused by intervention pumps.

Comparison of the Early Results of Supra-Annular and Intra-Annular Aortic Valve Replacement in Isolated Aortic Valve Replacement.

Objectives: This study aims to compare the early results of patients who underwent isolated aortic valve replacement (AVR) with supra-annular and intra-annular AVR. Methods: Between 2013 and 2019, 113 patients (77 males; mean age 57.8±16.36 years) who underwent isolated AVR were evaluated. The patients were divided into two groups those who underwent supra-annular (n=59) and intra-annular (n=54) AVR. The most commonly used valves in surgeries St Jude Medical Masters (St. Jude Medical, Minneapolis, MN, USA), (n=35, 30.9%), Sorin Mitroflow (Sorin Group Inc., Mitroflow Division, Canada), (n=32, 28.3%, and Carbomedics Top Hat (Sulzer, Carbomedics, Austin, TX), (n=31, 27.4%). Results: The cross-clamp (XCL) and cardiopulmonary bypass (CPB) times of the patients who underwent supra-annular AVR were found to be significantly higher than the patients who underwent intra-annular AVR. However, there was no significant difference between the two groups in terms of postoperative adverse events. There was no significant difference between the two groups in the postoperative first-week transthoracic echocardiographic (TTE) findings. Conclusion: When comparing supra-annular and intra-annular valve positioning results in patients undergoing isolated AVR, no significant difference was found between the groups in terms of postoperative complications, gradient differences in postoperative TTE, and ejection fractions. Supra-annular valve positioning should be considered, especially in patients with small annulus, in the presence of suitable anatomical features. However, this issue needs to be investigated in future prospective studies with more patients.

[Experimental Study on Effects of Mitral Regurgitation on Hydrodynamic Performance of Aortic Valve].

OBJECTIVE: Aims researches on the interaction between heart valves is limited in clinical. Meanwhile the data of in vitro testing are insufficient. In this study, the in vitro hydrodynamic performance of an aortic valve was studied by using a model of mitral regurgitation that could finely adjust the regurgitant volume. METHODS: The regurgitation of mitral valve was gradually increased under the certain condition of heart rate, stroke volume, and mean aortic pressure and captured the hydrodynamic performance of the aortic valve. RESULTS: The study on the hydrodynamic performance of mechanical aortic valve (25AJ-501) by using a model of mitral regurgitation found that the effective orifice area and mean pressure difference of the aortic valve are negatively correlated with the degree of mitral regurgitation. CONCLUSIONS: The method based on a model of mitral regurgitation that could finely adjust the regurgitant volume established in this study can be used to study the effect of mitral valve regurgitation on the hydrodynamic performance of the aortic valve.

Pledgeted versus nonpledgeted sutures in aortic valve replacement: Insights from a prospective multicenter trial.

Objective: The objective of this study was to compare short- and midterm clinical and echocardiographic outcomes according to the use of pledgeted sutures during aortic valve replacement. Methods: Patients with aortic stenosis or regurgitation requiring aortic valve replacement were enrolled in a prospective cohort study to evaluate the safety of a new stented bioprosthesis. Outcomes were analyzed according to the use of pledgets (pledgeted group) or no pledgets (nonpledgeted group). The primary outcome was a composite of thromboembolism, endocarditis, and major paravalvular leak at 5 years of follow-up. Secondary outcomes included multiple clinical endpoints and hemodynamic outcomes. Propensity score matching was performed to adjust for prognostic factors, and subanalyses with small valve sizes (<23 mm) and suturing techniques were performed. Results: The pledgeted group comprised 640 patients (59%), and the nonpledgeted group 442 (41%), with baseline discrepancies in demographic characteristics, comorbidities, and stenosis severity. There were no differences between groups in any outcome. After propensity score matching, the primary outcome occurred in 41 (11.7%) patients in the pledgeted and 36 (9.8%) in the nonpledgeted group (P = .51). The effective orifice area was smaller in the pledgeted group (P = .045), whereas no difference was observed for the mean or peak pressure gradient. Separate subanalyses with small valve sizes and suturing techniques did not show relevant differences. Conclusions: In this large propensity score-matched cohort, comprehensive clinical outcomes were comparable between patients who underwent aortic valve replacement with pledgeted and nonpledgeted sutures up to 5 years of follow-up, but pledgets might lead to a slightly smaller effective orifice area in the long run.

Patient-Prosthesis Mismatch Associated With Somatic Growth After Mechanical Mitral Valve Replacement in Small Children: Metrics for Reoperation and Outcomes.

Reoperation after pediatric mitral valve replacement (MVR) is inevitable due to patient-prosthesis mismatch (PPM) associated with somatic growth. We analyzed potential metrics for PPM and outcomes of redo MVR for valve upsizing. Between 1999 and 2018, 15 children without obstructive left heart lesions other than mitral stenosis underwent initial MVR with a 16-mm ATS-Advanced Performance valve. We analyzed hemodynamic data from 28 postoperative catheterizations and concomitant echocardiograms. The median age and body weight at initial MVR were 4.9 months (25th, 75th percentile: 3.6, 6.6) and 5.9 kg (5.0, 7.3). Redo MVR was planned when patients had congestive heart failure and postcapillary pulmonary hypertension (PH) due to PPM: systolic pulmonary arterial pressure (SPAP) >35 mm Hg and pulmonary capillary wedge pressure (PCWP) >15 mm Hg on catheterization. Indexed effective orifice area (iEOA) and mean transmitral pressure gradient (TMPG) were strongly correlated with SPAP (r = -0.72, P < 0.001 and r = 0.75, P < 0.001) and PCWP (r = -082, P < 0.001 and r = 0.84, P < 0.001). Cut-off values for detecting postcapillary PH due to PPM were 1.0 cm2/m2 for iEOA and 18 mm Hg for mean TMPG. Nine patients underwent redo MVR for postcapillary PH due to PPM at a median postoperative interval of 10 years (9.2, 11.9). All the patients survived, and PH was improved one year after surgery. iEOA and mean TMPG can be metrics for PPM in children after MVR. Careful follow-up is required to confirm the improvement of preoperatively existing PH after redo MVR for valve upsizing.

The ratio of measured and reference effective orifice areas for discriminating prosthetic aortic valve obstruction.

AIMS: We aimed to evaluate the efficacy of the measured effective orifice area (EOA)/reference EOA ratio in discriminating mechanical prosthetic aortic valve (PAV) obstruction. METHODS AND RESULTS: This is a retrospective study of 193 mechanical PAV patients with an elevated mean transprosthetic pressure gradient (PG) over 20 mmHg or peak velocity over 3 m/s. Of those, 143 patients were objectively proven PAV obstruction with cardiac computed tomography or surgical inspection. The EOA was measured using the continuity equation, and the reference EOA values were obtained from previous guidelines. The measured/reference EOA ratio was significantly lower in the obstruction group (0.63 ± 0.18 vs. 0.86 ± 0.17; P < 0.001). The EOA ratio added incremental value for discriminating obstruction from the conventional parameters recommended in the guidelines. Receiver operating characteristic curve analysis revealed that the measured/reference EOA ratio discriminated PAV obstruction from those without obstruction [area under the curve (AUC), 0.840; 95% confidence interval, 0.783-0.898; P < 0.001]. A cutoff of 0.71 had 73.4% sensitivity and 82.0% specificity. The novel diagnostic algorithm adding the EOA ratio had similar accuracy to previous guideline algorithms, including reference EOA, and conventional Doppler parameters (AUC, 0.763 vs. 0.731; P = 0.309). In patients with a large PAV (≥23 mm), the novel algorithm had higher accuracy than the previous algorithm (AUC, 0.788 vs. 0.642; P = 0.019). CONCLUSION: The ratio of measured/reference EOA adds incremental value over conventional Doppler parameters and might be helpful for distinguishing PAV obstruction.

Experimental Study on Effects of Mitral Regurgitation on Hydrodynamic Performance of Aortic Valve / 中国医疗器械杂志

OBJECTIVE@#Aims researches on the interaction between heart valves is limited in clinical. Meanwhile the data of in vitro testing are insufficient. In this study, the in vitro hydrodynamic performance of an aortic valve was studied by using a model of mitral regurgitation that could finely adjust the regurgitant volume.@*METHODS@#The regurgitation of mitral valve was gradually increased under the certain condition of heart rate, stroke volume, and mean aortic pressure and captured the hydrodynamic performance of the aortic valve.@*RESULTS@#The study on the hydrodynamic performance of mechanical aortic valve (25AJ-501) by using a model of mitral regurgitation found that the effective orifice area and mean pressure difference of the aortic valve are negatively correlated with the degree of mitral regurgitation.@*CONCLUSIONS@#The method based on a model of mitral regurgitation that could finely adjust the regurgitant volume established in this study can be used to study the effect of mitral valve regurgitation on the hydrodynamic performance of the aortic valve.

Surgical versus transcatheter aortic valve replacement: Impact of patient-prosthesis mismatch on outcomes.

BACKGROUND: The hemodynamics of most prosthetic valves are often inferior to that of the normal native valve, and a significant proportion of patients undergoing surgical (SAVR) or transcatheter aortic valve replacement (TAVR) have high residual transaortic pressure gradients due to prosthesis-patient mismatch (PPM). As the experience with TAVR has increased and long-term outcomes are reported, a close look at the PPM literature is required in light of new evidence. METHODS: For this review, we searched the Embase, Medline, and Cochrane databases from 2000 to 2022. Articles reporting PPM as an outcome following aortic valve replacements were identified and reviewed. RESULTS: The impact of PPM on clinical outcomes in aortic valve replacement has not been clear as multiple studies failed to report PPM incidence. However, the PPM outcomes after SAVR vary more widely than after TAVR, ranging from 8% to 80% in SAVR and from 24% to 35% in TAVR. Incidence of severe PPM following redo SAVR ranges from 2% to 9% and following valve-in-valve TAVR is from 14% to 33%, however, while PPM is higher in valve-in-valve TAVR, patients had better survival rates. CONCLUSIONS: The gap between valve performance and clinical outcomes in SAVR and TAVR could be reduced by carefully selecting patients for either treatment option. Understanding predictors of PPM can add to the safety, effectiveness, and increased survival benefit of both SAVR and TAVR.

Durability of a bovine pericardial aortic bioprosthesis based on Valve Academic Research Consortium-3 echocardiographic criteria.

Objectives: The Carpentier-Edwards Perimount Magna Ease (Edwards Lifesciences) pericardial bioprosthesis has demonstrated satisfying hemodynamics at midterm follow-up, but its durability remains unclear. We report our 10-year experience with this third-generation valve implanted in the aortic position, with particular attention to structural valve deterioration. Methods: From 2007 to 2016 at our center, 338 patients underwent aortic valve replacement using the Perimount Magna Ease pericardial bioprosthesis. Patients were prospectively followed (mean 6.6 ± 2.6 years) with clinical evaluation and yearly echocardiography. Follow-up was 98% complete (7 patients lost) for a total of 2238 valve-years. Bioprosthesis structural valve deterioration was determined by strict echocardiographic assessment based on the Valve Academic Research Consortium 3 criteria. Results: Overall operative mortality was 1.2%. Actuarial survival including early deaths averaged 80.9% ± 2.2% and 66.7% ± 4.4% after 5 and 10 years of follow-up, respectively. Actuarial freedom from explantation due to structural valve deterioration at 5 and 10 years was 99.6% ± 0.4% and 88.8% ± 5.0%, respectively, and actuarial freedom of structural valve deterioration at 5 and 10 years was 98.5% ± 0.7% and 44.0% ± 6.4%, respectively. More precisely, actuarial freedom of structural valve deterioration stage 3 was 99.6% ± 0.4% at 5 years and 88.3% ± 5.0% at 10 years, whereas freedom of structural valve deterioration stage 2/3 was 98.5% ± 0.7% and 60.9% ± 7.0%, respectively. Conclusions: With a low rate of explantation due to structural valve deterioration events at 10 years, and particularly a low rate of moderate or severe structural valve deterioration based on echocardiographic Valve Academic Research Consortium 3 criteria, the Carpentier-Edwards Perimount Magna Ease pericardial bioprosthesis remains a reliable choice for a tissue valve in the aortic position.

Long-term durability of a new surgical aortic valve: A 1 billion cycle in vitro study.

Background: This study assessed the long-term hemodynamic functional performance of the new Inspiris Resilia aortic valve after accelerated wear testing (AWT). Methods: Three 21-mm and 23-mm Inspiris valves were used for the AWT procedure. After 1 billion cycles (equivalent to 25 years), the valves' hemodynamic performance was compared with that of the corresponding zero-cycled condition. Next, 1 AWT cycled valve of each valve size was selected at random for particle image velocimetry (PIV) and leaflet kinematic tests, and the data were compared with data for an uncycled Inspiris Resilia aortic valve of the same size. PIV was used to quantitatively evaluate flow fields downstream of the valve. Valves were tested according to International Standards Organization 5840-2:2015 protocols. Results: The 21-mm and 23-mm valves met the International Organization for Standardization (ISO) durability performance requirements to 1 billion cycles. The mean effective orifice areas for the 21-mm and 23-mm zero-cycled and 1 billion-cycled valves were 1.89 ± 0.02 cm2 and 1.94 ± 0.01 cm2, respectively (P < .05) and 2.3 ± 0.13 cm2 and 2.40 ± 0.11 cm2, respectively (P < .05). Flow characterization of the control valves and the study valves demonstrated similar flow characteristics. The velocity and shear stress fields were also similar in the control and study valves. Conclusions: The Inspiris Resilia aortic valve demonstrated very good durability and hemodynamic performance after an equivalent of 25 years of simulated in vitro accelerated wear. The study valves exceeded 1 billion cycles of simulated wear, 5 times longer than the standard requirement for a tissue valve as stipulated in ISO 5840-2:2015.

Flow dynamics of surgical and transcatheter aortic valves: Past to present.

Objective: To perform an in vitro characterization of surgical aortic valves (SAVs) and transcatheter aortic valves (TAVs) to highlight the development of the flow dynamics depending on the type of valve implanted and assess the basic differences in the light of flow turbulence and its effect on blood damage likelihood and hemodynamic parameters that shed light on valve performance. Methods: A Starr-Edwards ball and cage valve of internal diameter 22 mm, a 23-mm Medtronic Hancock II SAV, a 23-mm St Jude Trifecta SAV, a 23-mm St Jude SJM (mechanical valve) SAV, a 26-mm Medtronic Evolut TAV, and a 26-mm Edwards SAPIEN 3 TAV were assessed in a pulse duplicator under physiological conditions. Particle image velocimetry was performed for each valve. Pressure gradient and effective orifice area (EOA) along with velocity flow field, Reynolds shear stress (RSS), and viscous shear stress (VSS) were calculated. Results: The SJM mechanical valve exhibited the greatest EOA (1.96 ± 0.02 cm2), showing superiority of efficiency compared with the same-size Trifecta (1.87 ± 0.07 cm2) and Hancock II (1.05 ± 0.01 cm2) (P < .0001). The TAVs show close EOAs (2.10 ± 0.06 cm2 with Evolut and 2.06 ± 0.03 cm2 with SAPIEN 3; P < .0001). The flow characteristics and behavior downstream of the valves differed depending on the valve type, design, and size. The greater the RSS and VSS the more turbulent the downstream flow. Hancock II displays the greatest range of RSS and VSS magnitudes compared with the same-size Trifecta and SJM. The Evolut displays the greatest range of RSS and VSS compared with the SAPIEN 3. Conclusions: The results of this study shed light on numerous advancements in the design of aortic valve replacement prosthesis and the subsequent hemodynamic variations. Future surgical and transcatheter valve designs should aim at not only concentrating on hemodynamic parameters but also at optimizing downstream flow properties.

Functional performance of 8 small surgical aortic valve bioprostheses: an in vitro study.

OBJECTIVES: Selection of a surgical aortic valve (SAV) bioprosthesis model for the treatment of aortic valve disease remains controversial. The aim of this study was to characterize the functional performance of 8 SAV models in a standardized in vitro setting. METHODS: The hydrodynamic performance of 8 SAVs with labelled size 21 mm (Avalus™, Hancock® II, Mosaic® Ultra™, Perimount®, Perimount® Magna Ease, Epic™ Supra, Trifecta™ GT; Freestyle®), was investigated in a pulse duplicator. Transvalvular pressure gradients and effective orifice area (EOA) were recorded. The geometrical orifice area and physical dimensions of the valves were determined, and new functional dimensions were introduced. RESULTS: Mean pressure gradient (MPG) and EOA differed significantly between the analysed SAVs. The Epic presented with the lowest EOA and highest MPG, while the Trifecta showed the highest EOA and the lowest MPG. We introduce a useful way to determine the minimal internal diameter and a new measure termed 'relative orifice area' to characterize a valve's performance. CONCLUSIONS: SAVs showed significant differences in their hydrodynamic performance despite the same label size. This finding was related to the construction of the valves. We introduce a new measure that characterizes the functional performance of a valve model and size for the treatment of an aortic annulus of a specific size. Our data emphasize that SAV selection should carefully be done using an individual patient approach and that future research is necessary to improve the current generation of SAVs.

Prosthesis-patient mismatch after transcatheter aortic valve implantation.

Prosthesis-patient mismatch (PPM), first described in 1978, occurs when a prosthetic valve functions normally, but has an effective orifice area that is too small relative to the patient's body surface area. It results in residual left ventricular afterload and higher transvalvular pressure gradient, which has been considered to impair prognosis. PPM following surgical aortic replacement is reportedly associated with worse clinical outcomes, such as high mortality. However, the impact of PPM on clinical outcomes after transcatheter aortic valve implantation (TAVI) remains unclear. There is conflicting evidence on the impact of PPM following TAVI due to differences across studies in terms of follow-up period, methods, patient populations, and type of bioprosthetic valve. The present review summarizes the most recent evidence on PPM after TAVI.

Delivery balloon volume positively correlates with the diameter and effective orifice area of implanted SAPIEN 3.

BACKGROUND: In transcatheter aortic valve replacement (TAVR) using SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, CA, USA), some clinicians decrease or increase the delivery balloon volume (VOL) when deploying S3 or conducting post-dilatation. However, the effects of controlling VOL on transcatheter heart valve diameter (THVD) and valve function remain unclear. We assessed associations among VOL, THVD, and effective orifice area (EOA) of S3. METHODS: We enrolled patients undergoing TAVR using 23- and 26-mm S3 in Sendai Kousei Hospital between 2017 and 2019. VOL was controlled based on preprocedural computed tomography and intraprocedural transesophageal echocardiography (TEE). THVD were defined as the diameters of transcatheter heart valve at mid-level measured by TEE. RESULTS: In enrolled 332 patients (23-mm, n = 188; 26-mm, n = 144), one (0.3%) and two (0.6%) developed annulus rupture and moderate/severe paravalvular leak, respectively. VOL at deployment was positively correlated with THVD on deployment (23-mm, r = 0.44, p < 0.001; 26-mm, r = 0.57, p < 0.001) and EOA (23-mm, r = 0.23, p = 0.0019; 26-mm, r = 0.22, p = 0.0094). In multiple regression analyses, VOL and post-dilatation were significant determinants of THVD, although aortic annulus area, calcium volume, and pre-dilatation were not. The areas under the receiver operating characteristic curve that were used to evaluate the accuracy of the index obtained by dividing THVD by body surface area (indexed THVD) to predict patient-prosthesis mismatch (PPM) were 0.744 and 0.811 in the 23- and 26-mm cohorts, respectively. A cut-off indexed THVD of ≤11.5 and 12.1 mm/m2 well predicted PPM (23-mm, odds ratio, 5.20; 95% confidence interval, 1.33-20.3; 26-mm, odds ratio 14.1, 95% confidence interval 2.40-81.0). CONCLUSION: VOL was positively correlated with THVD and EOA. Smaller indexed THVD was associated with a higher incidence of PPM. Controlling VOL under on-site THVD evaluation may be useful in reducing the PPM incidence.

Patient Prosthesis Mismatch After SAVR and TAVR.

Patient-prosthesis mismatch (PPM) remains one out of many factors to be considered during decision-making for the treatment of aortic valve pathologies. The idea of adequate sizing of a prosthetic heart valve was established by Rahimtoola already in 1978. In this article, the author described the phenomenon that the orifice area of a prosthetic heart valve may be too small for the individual patient. PPM is assessed by measurement or projection of the prosthetic effective orifice area indexed to body surface area (iEOA), while it is recommended to use different cut point values for non-obese and obese patients for the categorization of moderate and severe PPM. Several factors influence the accuracy of both the projected and the measured iEOA for PPM assessment, which leads to a certain number of false assignments to the PPM or no PPM group. Despite divergent findings on the impact of PPM on clinical outcomes, there is consensus that PPM should be avoided to prevent sequelae of increased prosthetic gradients after aortic valve replacement. To prevent PPM, it is required to anticipate the iEOA of the prosthesis prior to the procedure. The use of adequate reference tables, derived from echocardiographically measured mean effective orifice area (EOA) values from preferably large numbers of patients, is most appropriate to predict the iEOA. Such tables should be used also for transcatheter heart valves in the future. During the decision-making process, all available options should be taken into account for the individual patient. If the predicted size and type of a surgical prosthesis cannot be implanted, additional surgical procedures, such as annular enlargement with the Manougian technique, or alternative procedures, such as transcatheter aortic valve implantation (TAVI) can prevent PPM. PPM prevention for TAVI patients is a new field of interest and includes anticipation of the iEOA, prosthesis selection, and procedural strategies.

Orifice Areas of Balloon-Expandable Transcatheter Heart Valves: A Three-Dimensional Transesophageal Echocardiographic Study.

BACKGROUND: Accurate expected effective orifice area (EOA) values for balloon-expandable (BE) transcatheter heart valves (THV) are crucial for preventing patient-prosthesis mismatch (PPM) and assessment of THV function. Currently published reference EOAs, however, are based on transthoracic echocardiography (TTE), which may be subject to left ventricular outflow tract diameter underestimation and/or suboptimal THV Doppler interrogation. The objective of this study was to establish reference EOA values for BE THVs on the basis of Doppler and three-dimensional (3D) transesophageal echocardiography (TEE). METHODS: Two hundred twelve intraprocedural transesophageal echocardiographic examinations performed during BE THV implantation with optimal postimplantation Doppler and 3D imaging were retrospectively reviewed. Continuity equation-derived EOAs were compared with geometric orifice areas by 3D planimetry (GOA3D). Performance indices (i.e., EOA normalized to valve size) and PPM rates were determined. TTE-based EOAs obtained within 30 days were also calculated in a subset of 170 patients. RESULTS: The average EOA for all BE THV valves (77% SAPIEN 3) was 2.3 ± 0.5 cm2, while the average EOA was 1.6 ± 0.2 cm2 for 20-mm, 2.0 ± 0.2 cm2, for 23-mm, 2.5 ± 0.3 cm2 for 26-mm, and 3.0 ± 0.3 cm2 for 29-mm THV size (P < .001). Bland-Altman analysis demonstrated very good agreement between EOA and GOA3D (bias -0.04 ± 0.15 cm2). There were strong correlations between annular area and TEE-based EOA (R = 0.84) and GOA3D (R = 0.87). The mean performance index was 47 ± 5% and was similar for all THV sizes (P = .21). EOAs based on TTE were smaller compared with those based on TEE, while the correlation with annular area (R = 0.67) and agreement with GOA3D (bias -0.26 ± 0.43 cm2) was not as strong. The overall PPM rate was 2% in the TEE cohort and 12% in the TTE cohort. CONCLUSIONS: EOAs for BE THVs based on intraprocedural Doppler and 3D TEE suggest that previously published TTE-based reference values for EOA are underestimated, while PPM rates may be overestimated. Our findings have important clinical implications for preimplantation decision-making and for the evaluation of THV hemodynamics and function during follow-up.

Transcatheter Aortic Valve Replacement for Bicuspid Aortic Insufficiency After Valve-Sparing Aortic Root Replacement.

Bicuspid aortic insufficiency (BAI) patients with root aneurysm often require aortic valve and root replacement in a composite procedure. The valve-sparing root replacement (VSARR) procedure is aimed at preserving the native valve when possible. This case highlights a successful transcatheter aortic valve replacement procedure in a BAI patient previously treated with VSARR. (Level of Difficulty: Intermediate.).