Prosthetic Valve Regurgitation Research Articles

TCT-79 Multimodality Assessment of Prosthetic Valve Regurgitation to Predict Reverse Cardiac Remodeling and Long-Term Clinical Outcomes After Transcatheter Aortic Valve Replacement: Results From the Prospective POST-TAVI Registry

Prosthetic valve regurgitation (PVR) is associated with increased early and midterm mortality after transcatheter aortic valve replacement (TAVR); but, its impact on long-term outcomes in not known, and the relevant cutpoints of severity are not adequately validated. We sought to investigate the

Self-expanding transcatheter aortic valve implantation for degenerated Mitroflow bioprosthesis: Early outcomes

BackgroundThe aim of this study was to assess the safety and effectiveness of valve in valve (VIV) TAVI with the autoexpandable valve, specifically in patients with failed Mitroflow (MF) bioprosthetic aortic valves. MethodsPilot, single center, observational and prospective study that included 45 consecutive patients with symptomatic failed MF bioprosthetic aortic valve, referred for VIV TAVI. The safety primary endpoint was a composite of early events at 30 days, defined by VARC-2 criteria. The efficacy primary endpoint was the device success (no procedural mortality, correct positioning of a single prosthetic heart valve into the proper anatomical location and absence of moderate/severe prosthetic aortic valve regurgitation). We also analysed patient-prosthesis mismatch (PPM) parameters. ResultsBetween March 2012 to December 2017, 45 symptomatic patients (age 79.9 ± 6.5 years) with degenerated MF valves (numbers 19: 33.3%; 21: 28.9%; 23: 24.4%; 25: 13.3%) underwent CoreValve (n = 11) or Evolut R (n = 34) implantation (23 and 26 mm sizes). The STS predicted risk of mortality was 6.3 ± 6.3%. The safety primary endpoint occurred in 4 patients (8.8%). The efficacy endpoint was present in all patients (100%). There were no coronary occlusions or procedural deaths. The number of patients with any degree of PPM raised from 51.1% (pre-TAVI) to 60% (post-TAVI). ConclusionsSelf-expanding TAVI for degenerated MF bioprosthesis has favourable early outcomes. The VIV procedure has provided an important gateway to avoiding high-risk redo surgery and is now a potential option for MF failed surgically aortic implanted valves.

Study Protocol for Transcatheter Aortic Valve Replacement for a Degenerated Aortic Bioprosthesis in a Japanese Cohort

Background: The valve-in-valve (VIV) procedure is being increasingly performed in high-risk patients with a degenerated bioprosthesis in an aortic position in Western countries. The early safety and efficacy of the VIV procedure, however, remain unclear in Japanese patients with a small aortic annulus. We present the protocol for a study designed to evaluate the early safety and efficacy of the VIV procedure in the aortic position in Japanese patients. Methods and Results: The prospective, single-center, non-comparative, clinical study of the VIV procedure for the aortic position (AORTIC VIV study) commenced in August 2016 and will end in March 2020. Patients will be monitored for ≥1 month after the VIV procedure. The targeted number of patients is 11. Eligible patients are those who have undergone transcatheter aortic valve replacement for a surgical valve (including stented or stentless bioprosthetic valves), or for a transcatheter heart valve. The VIV procedure is performed in high-operative-risk patients with substantial prosthetic valve stenosis, and regurgitation and heart failure resistant to medical treatment (unless the patient meets an exclusion criterion). The safety and efficacy of the VIV procedure will be evaluated in accordance with the Valve Academic Research Consortium-2 initiative. Conclusions: The AORTIC VIV study will clarify the early safety and efficacy of the VIV procedure in Japanese patients.

One-Year Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement for Stenotic Bicuspid versus Tricuspid Aortic Valves: A Meta-Analysis and Meta-Regression.

Objective To assess 1-year mortality after transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic stenosis (AS). Background Clinical trials have proven the beneficial effect of TAVR on mortality in patients with tricuspid AS. Individuals with bicuspid AS were excluded from these trials. Methods A meta-analysis using literature search from the Cochrane, PubMed, ClinicalTrials, SCOPUS, and EMBASE databases was conducted to determine the effect of TAVR on 1-year mortality in patients with bicuspid AS. Short-term outcomes that could potentially impact one-year mortality were analyzed. Results After evaluating 380 potential articles, 5 observational studies were selected. A total of 3890 patients treated with TAVR were included: 721 had bicuspid and 3,169 had tricuspid AS. No statistically significant difference between the baseline characteristics of the two groups of patients was seen outside of mean aortic gradient. Our primary endpoint of one-year all-cause mortality revealed 85 deaths in 719 patients (11.82%) with bicuspid AS compared to 467 deaths in 3100 patients (15.06%) with tricuspid AS, with no difference between both groups [relative risk (RR) 1.03; 95% CI 0.70-1.51]. Patients with bicuspid AS were associated with a decrease in device success (RR 0.62; 95% CI 0.45-0.84) and an increase in moderate-to-severe prosthetic valve regurgitation (RR 1.55; 95% CI 1.07-2.22) after TAVR compared to patients with tricuspid AS. The effect of meta-regression coefficients on one-year all-cause mortality was not statistically significant for any patient baseline characteristics. Conclusion When comparing TAVR procedure in tricuspid AS versus bicuspid AS, there was no difference noted in one-year all-cause mortality.

Bioprosthetic Valve Performance After Transcatheter Aortic Valve Replacement With Self-Expanding Versus Balloon-Expandable Valves in Large Versus Small Aortic Valve Annuli: Insights From the CHOICE Trial and the CHOICE-Extend Registry

ObjectivesThe aim of this study was to compare self-expanding and balloon-expandable transcatheter heart valves (THVs) in large versus small aortic valve annuli. BackgroundThe degree of THV oversizing varies according to annular size, and this can modify the hemodynamic performance of self-expanding and balloon-expandable THVs. MethodsPatients undergoing transcatheter aortic valve replacement in the randomized CHOICE (Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve vs Edwards SAPIEN XT) trial (CoreValve [CV], n = 120; SAPIEN XT [SXT], n = 121) and the nonrandomized CHOICE-Extend registry (Evolut R [ER], n = 100; SAPIEN 3 [S3], n = 334) were compared for THV performance by echocardiography (in all patients) and by cardiac magnetic resonance imaging (MRI) regurgitant fraction (RF) (in a subgroup of patients). Patients were stratified according to aortic valve annular mean diameter into those with large (>23 mm) or small (≤23 mm) annuli. ResultsTHV percentage oversizing was 19.1 ± 6.4% with the CV, 11.4 ± 7.0% with the SXT, 18.8 ± 4.8% with the ER, and 3.7 ± 5.5% with the S3. Transvalvular mean pressure gradient was lower with the CV and ER than with the SXT and S3 in both the large and small annulus groups. In the randomized CHOICE trial, moderate to severe prosthetic valve regurgitation (PVR) was more with the CV than the SXT in large annuli (15.1% vs. 0.0%; p = 0.002; MRI RF: 10.5 ± 10.2% vs. 4.4 ± 4.5%; p = 0.036) but not in small annuli (0.0% vs. 5.7%; p = 0.50; MRI RF: 4.0 ± 4.1% vs. 4.0 ± 3.4%; p = 0.98). In the CHOICE-Extend registry, moderate to severe PVR occurred in 2 patients, and any PVR was not significantly different between the ER and the S3 in large (41.7% vs. 32.5%; p = 0.24) or small (47.1% vs. 43.8%; p = 0.84) annuli. MRI RF was not different in large annuli (5.0 ± 3.8% vs. 5.0 ± 6.1%; p = 0.99) but was significantly lower with the ER than the S3 in small annuli (2.9 ± 2.3% vs. 4.8 ± 3.7%; p = 0.023). On multivariate analysis, transcatheter aortic valve replacement with the ER in small annuli was associated with a lower rate of prosthesis-patient mismatch than with the S3, with no increased risk for PVR. ConclusionsOlder-generation balloon-expandable THVs were associated with less PVR than self-expanding THVs in patients with large but not small annuli. The next-generation self-expanding THV has improved sealing in patients with large annuli and may have potential advantages in patients with small annuli.

4285Impact of prosthetic valve regurgitation quantified by cardiac magnetic resonance imaging on long-term mortality after TAVI

4285Impact of prosthetic valve regurgitation quantified by cardiac magnetic resonance imaging on long-term mortality after TAVI

Two-Year Outcomes of Transcatheter Compared With Surgical Aortic Valve Replacement in “Minimal-Risk” Patients Lacking EuroSCORE Co-morbidities (from the TAVIK Registry)

We aimed to compare the outcomes of transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) in an elderly but nonfrail, minimally co-morbid population. Although data comparing these 2 procedures in intermediate- and low-risk patients are mounting, no distinction has been made between co-morbidity and age/gender as driving forces for surgical risk. Patients undergoing isolated TAVI or SAVR between May 2008 and March 2015 were documented. Data for 225 patients (TAVI 132, SAVR 93) aged ≥75 and <86 years and fulfilling minimal-risk criteria were analyzed. Patients who underwent TAVI were older (80.7 vs 77.4 years, p <0.0001) and had a higher mean Society of Thoracic Surgeons score (2.16% vs 1.72%, p <0.0001). Mild prosthetic valve regurgitation (odds ratio [OR] 4.9, 95% confidence interval [CI] 3.34 to 7.20) was more likely after TAVI, as were renal complications (predominantly stage I acute kidney injury; OR 2.86, 95% CI 1.79 to 4.55) and new pacemaker implantation (OR 3.33, 95% CI 1.76 to 6.26) at 30 days; however, life-threatening bleeding (OR 0.58, 95% CI 0.36 to 0.93) and reintervention for bleeding (OR 0.03, 95% CI 0.01 to 0.13) were less likely. Survival was comparable between groups at 30 days (99.2% vs 100%, p = 1.0) and 1 year (96.2% vs 96.8%, OR 0.85, 95% CI 0.20 to 3.63, p = 0.823), but it was poorer for patients who underwent TAVI at 2 years (OR 0.31, 95% CI 0.16 to 0.61). In conclusion, the short-term outcomes of TAVI in elderly, low-risk, minimally co-morbid patients appear to be similar to those of SAVR, with access-specific complications. Although these results point toward the potential for more liberal use of TAVI in minimal-risk patients, poorer midterm survival remains a concern, requiring further exploration.

A Novel Angiographic Quantification of Aortic Regurgitation After TAVR Provides an Accurate Estimation of Regurgitation Fraction Derived From Cardiac Magnetic Resonance Imaging

ObjectivesThis study sought to compare a new quantitative angiographic technique to cardiac magnetic resonance-derived regurgitation fraction (CMR-RF) for the quantification of prosthetic valve regurgitation (PVR) after transcatheter aortic valve replacement (TAVR). BackgroundPVR after TAVR is challenging to quantify, especially during the procedure. MethodsPost-replacement aortograms in 135 TAVR recipients were analyzed offline by videodensitometry to measure the ratio of the time-resolved contrast density in the left ventricular outflow tract to that in the aortic root (videodensitometric aortic regurgitation [VD-AR]). CMR was performed within an interval of ≤30 days (11 ± 6 days) after the procedure. ResultsThe average CMR-RF was 6.7 ± 7.0% whereas the average VD-AR was 7.0 ± 7.0%. The correlation between VD-AR and CMR-RF was substantial (r = 0.78, p < 0.001). On receiver-operating characteristic curves, a VD-AR ≥10% corresponded to >mild PVR as defined by CMR-RF (area under the curve: 0.94; p < 0.001; sensitivity 100%, specificity 83%), whereas a VD-AR ≥25% corresponded to moderate-to-severe PVR (area under the curve: 0.99; p = 0.004; sensitivity 100%, specificity 98%). Intraobserver reproducibility was excellent for both techniques (for CMR-RF, intraclass correlation coefficient: 0.91, p < 0.001; for VD-AR intraclass correlation coefficient: 0.93, p < 0.001). The difference on rerating was –0.04 ± 7.9% for CMR-RF and –0.40 ± 6.8% for VD-AR. ConclusionsThe angiographic VD-AR provides a surrogate assessment of PVR severity after TAVR that correlates well with the CMR-RF.

Videodensitometric quantification of paravalvular regurgitation of a transcatheter aortic valve: in vitro validation.

Videodensitometric assessment of aortography provides a periprocedural quantitation of prosthetic valve regurgitation (PVR) after transcatheter aortic valve implantation. We sought to compare the videodensitometric parameters of PVR severity to the regurgitation fraction (RF) in a controlled in vitro setting. In a mock circulation system, a transcatheter balloon-expandable valve inserted at the aortic valve position was gradually deformed to induce different grades of paravalvular leakage and the RF was measured with a transonic flow probe. Contrast aortography was performed and the following videodensitometric parameters were generated: left ventricle aortic regurgitation (LV-AR), LV outflow tract AR (LVOT-AR), quantitative regurgitation assessment (qRA) index, relative maximum density (relative max), and maximum upslope of the LV time-density curve. The correlation was substantial between videodensitometric parameters (LV-AR, LVOT-AR, qRA index, relative max, and maximum upslope) and RF (r2=0.96, 0.96, 0.93, 0.87, and 0.93; p<0.001 for all). LV-AR (region of interest [ROI]=entire LV) and LVOT-AR (ROI=LVOT) were not different (p=0.51) and were strongly correlated (r2=0.99) with a mean difference of 1.92% (95% limits of agreement: ±2.83). The correlations of LV-AR and LVOT-AR with RF were stronger when more than one cardiac cycle was included in the analysis (one cycle: r2=0.85 and r2=0.83; four cycles: r2=0.96 and r2=0.96, for LV-AR and LVOT-AR, respectively). Including more cycles beyond four did not improve accuracy. Quantitative assessment of PVR by videodensitometry of aortograms strongly correlates with the actual RF in a controlled in vitro setting. Accuracy is improved by including more than one cardiac cycle in the analysis.

Early Outcomes With the Evolut PRO Repositionable Self-Expanding Transcatheter Aortic Valve With Pericardial Wrap

ObjectivesThis study sought to evaluate the Medtronic Evolut PRO Transcatheter Aortic Valve System in patients with severe symptomatic aortic stenosis. BackgroundA next-generation self-expanding transcatheter aortic valve was designed with an external pericardial wrap with the intent to reduce paravalvular leak while maintaining the benefits of a low-profile, self-expanding, and repositionable supra-annular valve. MethodsThe Medtronic Evolut PRO Clinical Study included 60 patients undergoing transcatheter aortic valve replacement with the Evolut PRO valve at 8 investigational sites in the United States. Clinical outcomes at 30 days were evaluated using Valve Academic Research Consortium-2 criteria. The 2 primary safety endpoints were the incidence of all-cause mortality at 30 days and the incidence of disabling stroke at 30 days. The primary efficacy endpoint was the proportion of patients with no or trace prosthetic valve regurgitation at 30 days. An independent echocardiographic core laboratory (Mayo Clinic, Rochester, Minnesota) was used to adjudicate all echocardiographic assessments. ResultsAll 60 patients received the Evolut PRO valve. At 30 days, 1 patient (1.7%) died and 1 patient (1.7%) experienced a nonfatal disabling stroke. Paravalvular regurgitation at 30 days was absent or trace in 72.4% of patients and was mild in the remainder of patients, with no patients having worse than mild paravavlular leak. The mean atrioventricular gradient was 6.4 ± 2.1 mm Hg and effective orifice area was 2.0 ± 0.5 cm2 at 30 days. ConclusionsThe safety and efficacy results of this study support the use of the Evolut PRO System for the treatment of severe symptomatic aortic stenosis in patients who are at increased surgical risk, resulting in excellent hemodynamics and minimal paravalvular leak (The Medtronic TAVR 2.0 US Clinical Study; NCT02738853)

Transcatheter aortic valve implantation for mixed versus pure stenotic aortic valve disease.

In addition to patients with pure/predominant aortic stenosis (PAS), real-world transcatheter aortic valve implantation (TAVI) referrals include patients with mixed aortic valve disease (MAVD; severe stenosis+moderate-severe regurgitation). We sought to compare TAVI outcomes in patients with MAVD vs. PAS. Out of 793 consecutive patients undergoing TAVI, 106 (13.4%) had MAVD. Patients with MAVD were younger and had a higher operative risk, a more severe adverse cardiac remodelling, and a worse functional status than patients with PAS. Moderate-severe prosthetic valve regurgitation (PVR) was significantly more frequent in patients with MAVD than in patients with PAS (15.7% vs. 3.6%, p=0.003), even after propensity-score and multivariable adjustments. Moderate-severe PVR was associated with increased one-year mortality in patients with PAS (log-rank p=0.002), but not in patients with MAVD (log-rank p=0.27). Eventually, all-cause and cardiac mortality as well as the functional capacity were similar in the two study groups up to one year. A significant proportion of patients referred for TAVI in a real-world registry has MAVD. Moderate-severe AR at baseline can influence the rate and modify the clinical sequelae of post-TAVI PVR. Eventually, clinical outcomes in patients with MAVD are comparable to those in patients with PAS in the acute and midterm phases, in spite of a baseline higher risk. MAVD should not be considered a contraindication for TAVI.

P2966Quantitative assessment of prosthetic valve regurgitation after TAVI by angiography and cardiac magnetic resonance imaging

P2966Quantitative assessment of prosthetic valve regurgitation after TAVI by angiography and cardiac magnetic resonance imaging

1280Long-term impact of prosthetic valve regurgitation after transcatheter aortic valve implantation: a 5-year follow-up analysis from the German TAVI registry

1280Long-term impact of prosthetic valve regurgitation after transcatheter aortic valve implantation: a 5-year follow-up analysis from the German TAVI registry

Transcatheter Aortic Valve Implantation in Nonagenarians.

In this report, we assess the outcome of transcatheter aortic valve implantation (TAVI) in nonagenarians at our institution during a 6-year period. Between April 2008 and July 2014, 40 patients with a mean ± SD age of 91.8 ± 2.3 years (range, 90-98 years) underwent TAVI. Thirty-three patients (82.5%) received transapical TAVI, and seven patients (17.5%) received transfemoral TAVI. Baseline characteristics were as follows: mean ± SD EuroSCORE II, 23.9 ± 14.21; mean ± SD Society of Thoracic Surgeons mortality score, 24.2 ± 11.4; mean ± SD SYNTAX score, 7.6 ± 9.3; mean ± SD NYHA class, 3.5 ± 0.5; mean ± SD transvalvular gradient, 46.8 ± 17.8 mm Hg; mean ± SD aortic valve area, 0.7 ± 0.2 cm. Intraoperative mortality was 2.5% and 30-day all-cause mortality was 10%. The actuarial survival rates at 1 and 5 years were 58.6% and 30.4%, respectively. Seven patients (17.5%) underwent simultaneous elective TAVI and percutaneous coronary intervention. Three patients (7.5%) were operated on with the use of cardiopulmonary bypass. No conversion to open surgery occurred. In transesophageal echocardiography assessment, no moderate or severe prosthetic aortic valve regurgitation was observed. Four patients (10%) had postoperative acute renal failure stage 3 and needed new dialysis (P = 0.125). Three patients (7.5%) had a disabling stroke. Periprocedural myocardial infarction occurred in one patient (2.5%). Seven patients (17.5%) needed postoperative pacemaker implantation. Male sex and renal insufficiency were found to be predictors of mortality in univariable analysis. Transcatheter aortic valve implantation can be performed in nonagenarians despite very high preoperative risk scores and substantial multimorbidity, with acceptable outcomes.

Outcomes of Redo Transcatheter Aortic Valve Replacement for the Treatment of Postprocedural and Late Occurrence of Paravalvular Regurgitation and Transcatheter Valve Failure.

Transcatheter aortic valves can degenerate in a manner similar to surgical bioprostheses. Clinical and echocardiographic outcomes of patients who underwent redo transcatheter aortic valve replacement (TAVR) procedures >2 weeks post procedure were collected from 14 centers. Among 13 876 patients, 50 (0.4%) underwent redo TAVR procedure at participating centers. Indications for redo TAVR were moderate-severe prosthetic aortic valve stenosis (n=10, 21.7%), moderate-severe central prosthetic aortic valve regurgitation (n=13, 28.3%), and moderate-severe paraprosthetic aortic valve regurgitation (n=25, 50.0%). The index TAVR was most commonly a Medtronic CoreValve (N=38, 76.0%), followed by Edwards SAPIEN-type valves (n=12, 24.0%) and Portico (n=1, 2.0%). The redo TAVR device was most commonly a CoreValve/Evolut R (n=29, 58.0%), followed by a SAPIEN-type valve (n=20,40.0%) or a Boston Lotus valve (n=1, 2.0%). In 40 patients (80.0%), redo TAVR was performed using the identical device type or that of the succeeding generation. Valve performance was uniformly good after redo TAVR (mean transvalvular gradient post redo TAVR: 12.5±6.1 mm Hg). At hospital discharge, all patients remained alive, with 1 nondisabling stroke (2.0%) and 1 life-threatening bleed (2.0%). Permanent pacemaker implantation was required in 3 out of 35 patients without a prior pacemaker (8.6%). Late survival was 85.1% at a median follow-up of 1589 days (range: 31-3775) after index TAVR and 635 days (range: 8-2460) after redo TAVR. Redo TAVR for the treatment of postprocedural and late occurrence of paravalvular regurgitation and transcatheter aortic valve prosthesis failure seems to be safe, and it is associated with favorable acute and midterm clinical and echocardiographic outcomes.

A New Transcatheter Aortic Valve Replacement System for Predominant Aortic Regurgitation Implantation of the J-Valve and Early Outcome.

This study introduces a newly designed transcatheter aortic valve system, the J-Valve system, and evaluates its application in patients with predominant aortic regurgitation without significant valve calcification. We also report the early results of one of the first series of transapical implantations of this device and aim to offer guidance on the technical aspects of the procedure. Transcatheter aortic valve replacement (TAVR) has been widely used in high-risk patients for surgical aortic valve replacement. However, the majority of the TAVR devices were designed for aortic valve stenosis with significant valve calcification. Six patients with native aortic regurgitation without significant valve calcification (age, 61 to 83 years; mean age, 75.50 ± 8.14 years) underwent transapical implantation of the J-Valve prosthesis (JieCheng Medical Technology Co., Ltd., Suzhou, China), a self-expandable porcine valve, in the aortic position at our institution. All patients were considered to be prohibitive or high risk for surgical valve replacement (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation], 22.15% to 44.44%; mean, 29.32 ± 7.70%) after evaluation by an interdisciplinary heart team. Procedural and clinical outcomes were analyzed. Implantations were successful in all patients. During the follow-up period (from 31 days to 186 days, mean follow-up was 110.00 ± 77.944 days), only 1 patient had trivial prosthetic valve regurgitation, and none of these patients had paravalvular leak of more than mild grade. There were no major post-operative complications or mortality during the follow-up. Our study demonstrated the feasibility of transapical implantation of the J-Valve system in high-risk patients with predominant aortic regurgitation.

Echocardiographic evaluation of prosthetic heart valves.

The specific flow pattern and imaging features of prosthetic heart valves poses major challenges for the Doppler echocardiographic assessment of prosthetic valve structure and function. A comprehensive approach that integrates several semi-quantitative and quantitative parameters obtained from multiple views is key to appropriately detect and quantitate prosthetic valve dysfunction and complications. In patients with prosthetic valves, and particularly in those with mitral prostheses, transesophageal echocardiography is often required to confirm and/or complement information obtained by transthoracic echocardiography. Three-dimensional echocardiography may provide incremental information for the identification of the underlying etiology of prosthetic valve stenosis or regurgitation. Transcatheter aortic valve implantation has rapidly expanded in the past 10 years and paravalvular regurgitation is frequent following this procedure. Given that paravalvular regurgitant jets are often multiple, irregular, and eccentric, the grading of this type of regurgitation is particularly challenging and requires an integrative multiwindow, multiplane, multiparametric approach.

Incidence and Risk Factors of Hemolysis After Transcatheter Aortic Valve Implantation With a Balloon-Expandable Valve

There are currently no data evaluating the hematologic and biocompatibility profile of transcatheter aortic valves invivo. We evaluated the incidence, predictive factors, and clinical consequences associated with hemolysis post-transcatheter aortic valve implantation (TAVI). A total of 122 patients who underwent TAVI with a balloon-expandable valve were included. Baseline blood sampling and echocardiography, followed by early post-TAVI echocardiography and repeat blood sampling, at 6 to 12months post-TAVI were performed. Hemolysis post-TAVI was defined according to the established criteria. The incidence of hemolysis post-TAVI was 14.8% yet no patient experienced severe hemolytic anemia requiring transfusion. Compared with the nonhemolysis group, those with hemolysis demonstrated significant reductions in hemoglobin (p= 0.012), were more frequently women (67% vs 34%, p= 0.016), and had a higher incidence of post-TAVI severe prosthesis-patient mismatch (PPM) (44% vs 17%, p= 0.026). The rate of mild or more prosthetic valve regurgitation did not significantly differ between those patients with and without hemolysis (56% vs 37%, p= 0.44). Wall shear rate (WSR) and energy loss index (ELI), both indirect measures of shear stress, were higher (p= 0.039) and lower (p= 0.004), respectively, in those patients with hemolysis. Increasing PPM severity was also associated with significant stepwise WSR increments and ELI decrements (p <0.01 for both). In conclusion, subclinical hemolysis occurred in 15% of patients following TAVI. Although prosthetic valve regurgitation had no impact on hemolysis, a novel association between PPM and hemolysis was found, likely driven by higher shear stress as determined by WSR and ELI. These hematologic and biomechanical findings may have long-term clinical implications and could affect future transcatheter aortic valve design.

Transapical Mitral Implantation of the Tiara Bioprosthesis: Pre-Clinical Results

This study sought to describe the pre-clinical evaluation of transapical mitral implantation of the Tiara (Neovasc Inc, Vancouver, British Columbia, Canada) valve in preparation for first-in-man implantation.The Tiara is a transcatheter self-expanding mitral bioprosthesis, specifically designed for the complex anatomic configuration of the mitral apparatus.Tiara valves were implanted in a short-term porcine model, in a long-term ovine model, and in human cadavers.Short-term and long-term evaluation demonstrated excellent function and alignment of the valves, with no left ventricular outflow tract obstruction, coronary artery obstruction, or transvalvular gradients. Long-term evaluation of 7 sheep demonstrated clinically stable animals. A mild degree of prosthetic valve regurgitation was seen in 2 of the 7 sheep. A mild-to-moderate degree of paravalvular leak, which was attributed to this animal model, was observed in 6 of these animals. Cardioscopy and macroscopic evaluation demonstrated stable and secure positioning of the Tiara valve with no evidence of injury to the ventricular or atrial walls. Pericardial leaflets were free and mobile without calcifications. Implantation of the Tiara valves in human cadaver hearts demonstrated, upon visual inspection, proper anatomic alignment and seating of the valve, both at the atrial and at the ventricular aspects of the native mitral apparatus.In preparation for the first-in-man transcatheter mitral valve implantation, we report the successful pre-clinical evaluation of the Tiara transcatheter self-expanding mitral bioprosthetic valve. In porcine and ovine models without mitral regurgitation, transapical mitral implantation of the Tiara valve is technically feasible and safe, and results in a stable and well-functioning mitral bioprosthesis.

Severity of the Loss of High Molecular Weight Multimers Is Associated with Heyde Syndrome in Patients with Severe Aortic Stenosis.

AbstractAbstract 2230 Background:Heyde syndrome describes patients with severe aortic stenosis (AS) who have bleeding diathesis, especially gastrointestinal bleeding. Although acquired won Willebrand syndrome (AVWS) due to loss of the highest molecular weight multimers (HMWM) presents in most patients with severe AS, not all such patients develop Heyde syndrome. The goal of this study was to explore whether the severity of HMWM loss was significantly associated with Heyde syndrome. Methods:We first performed chart reviews on patients referred for double balloon enteroscopy (DBE) for GI bleeding or iron-deficiency anemia (GIB/FeDefic) in two time periods, from 2005–2008, and from 2009–2011. Next, patients who could have AVWS due to AS or other cardiovascular or hematologic disorders were identified. Laboratory tests including VWF antigen (VWF:Ag), VWF ristocetin cofactor activity or VWF latex immunoturgidic activity (VWF:Ltx) and/or VWF multimer analysis were performed as requested by physicians. From this population, patients with Heyde syndrome were identified. Their clinical and VWF laboratory testing results were compared to a separated group of patients with severe AS patients who had no clinically significant bleeding, but had matched gender and hemodynamic severity by echocardiogram (Matched AS Controls). These patients all had VWF:Ag, VWF:Ltx, and VWF multimers performed. In both Heyde syndrome patients and Matched AS controls, VWF multimer densitometry ratio of the HMWM (>15 mers) to low to intermediate multimers (2–15 mers) was assessed (VWF:multi ratio). Results:Overall, 437 patients underwent DBE for GIB/FeDef. Between 2005 and 2008, 1% of 318 patients had VWF testing. From 2009 to 2011, 23% of 119 patients were tested. Heyde syndrome was noted in 15 patients. Of the 437 patients, 134 patients (31%) likely had AVWS based on diagnoses of moderate-severe AS (30%), moderate to severe mitral regurgitation (25%), moderate to severe pulmonary hypertension (16%), prosthetic valve regurgitation or stenosis (13%), hypertrophic cardiomyopathy (10%), and hematologic disorders (4%). Among these 134 patients, 29 patients had VWF tests performed, and 22 had VWF multimer analysis. VWF antigen levels were similar in Heyde syndrome and Matched AS Controls (176±89% versus 155±77% respectively). Despite similar hemodynamic severity, more severe HMWM loss as indicated by lower VWF:Ltx/Ag and VWF:multi ratios was present in Heyde syndrome patients than matched AS controls (table, P<0.0007).Age, yearsMean gradient, mm HgVWF: Ltx/VWF:AgVWF:multi ratiosPFA-CADPHeyde (n=15)76±9†47±12†0.78±0.06*0.106±0.033*203±57†Matched AS Controls (n=25)78±1147±150.89±0.050.143±0.015174±121N=10 for VWF activity/antigen and PFA-CAPD in Heyde syndrome patients.*p<0.0007.†p=NS Conclusion:If AVWS is suspected in patients with GIB/FeDef, laboratory testing for VWF indices is important to confirm the diagnosis of AVWS. Despite similar hemodynamic severity, Heyde syndrome patients have more severe VWF HMWM loss indicated by significantly decreased VWF:Ltx/VWF:Ag and VWF:multi ratios. Conversely, though highly sensitive for AVWS, PFA-CADP does not predict bleeding tendency in patients with severe AS. Disclosures:No relevant conflicts of interest to declare.