Significant Paravalvular Regurgitation Research Articles

HAEMODYNAMIC FORCES ANALYSIS IN PATIENTS WITH PARAVALVULAR REGURGITATION AFTER TAVR: A PROPENSITY–SCORE MATCHED RETROSPECTIVE STUDY

Abstract Background Paravalvular regurgitation (PVR) after TAVR is a frequent complication, but its direct quantification and grading with conventional echocardiography is still limited by several factors. LV remodeling has still a role in the evaluation of PVR and its pathophysiology. Hemodynamic forces (HDF) analysis has emerged as a new tool to evaluate LV cardiac function in addiction to ejection fraction (EF) and global longitudinal strain (GLS). Aim of the study: To evaluate the difference in pre– and post–TAVR HDF in patients with preserved EF, using a propensity–matched analysis comparing patients with more than mild PVR to patients with mild or no PVR. Medis Ultrasound Suite software has been used for the estimation of HDF in order to differentiate earlier LV function modification between the two groups and its relationship with clinical outcomes. Material and Methods 25 patients from two European high–volume centers with more than mild PVR and coupled pre– and post–TAVR echocardiographic evaluation available for HDF analysis were retrospectively included, paired 1:2 with 50 patients, matched for characteristics that may influence HDF analysis and with mild or none PVR. Clinical outcome was a composite of heart failure (HF) valve–related hospitalization and worsening HF at 1 year. Results No significative differences were found at baseline clinical and echocardiography evaluation between the two groups: median age was 83 years, mean LVEF was 61%. Post–procedural echocardiographic evaluation was performed at 34 days after TAVR (IQR 5 – 50). Patients with significant PVR had higher LV end–diastolic volume (p = 0.044), lower endocardial GLS (p = 0.07) and lower LV diastolic apex–base longitudinal forces (LVD Apex–Base) (p = 0.045). The difference between LVD Apex–base pre– and post–TAVR was significantly lower in the significant PVR group (–0.8 vs 0.3%, p = 0.021). At Cox regression analysis, LV longitudinal force (LVLF) Ratio turned out to be predictive of clinical outcome (HR 1.11, 95CI 1.02 – 1.20, p = 0.017) in the overall population. Conclusion HDF analysis seems to be superior to conventional echocardiographic values of left ventricular cardiac function to detect the early effects of LV volume overload in patients with significant PVR after TAVR. Furthermore, in the overall population, LVLF Ratio predicts clinical outcomes and could be a promising new index to better evaluate the development of heart failure in patients with AS undergoing TAVR.

Abstract 14286: Rapid Involution of a Bioprosthetic Transcatheter Aortic Valve Replacement Presenting as Late Bioprosthetic Stenosis

A 65 year old male with a bioprosthetic 29 mm Edwards Sapien Ultra S3 TAVR implant for symptomatic severe aortic stenosis presented for evaluation after a 30-day transthoracic echocardiogram demonstrated bioprosthetic valve stenosis. Following TAVR deployment, TEE showed normal bioprosthetic valve function without evidence of significant paravalvular regurgitation. There were no procedural complications. Echocardiogram performed 1-day post-implantation demonstrated expected transvalvular gradients and valve area. The patient reported immediate symptomatic improvement following TAVR. At 30 days post-implant, TTE demonstrated a peak velocity of 3.37 m/s, mean gradient of 29 mmHg, dimensionless index of 0.29, and effective valve orifice area of 0.9 cm2. This was associated with a progressive decline in exercise capacity. At 57 days post-implant, TEE showed tissue growth of the aortic root anterior to the valve stent, causing deformation and under-expansion of the valve architecture from a circular to an ovoid shape. Notably, the bioprosthetic leaflets did not appear thickened or calcified, but exhibited restricted motion as a result of the abnormal valve architecture. Peak velocity had further increased to 4.6 m/s, with a mean gradient of 57 mmHg, dimensionless index of 0.21, and calculated effective orifice area of 0.52 cm2. Bioprosthetic aortic valve valve stenosis is an expected complication of valve replacement, though typically characterized by progressive leaflet calcification and pannus formation over several years or by valve thrombosis. Here, we present a rare case of rapidly progressive bioprosthetic TAVR stenosis identified at 30 days post-implantation after normal morphology and gradients on immediate and 1-day imaging. Stenosis was characterized by a process of tissue growth anterior to the stent with involution and underexpansion of the stent architecture and morphologically normal leaflet tissue.

Transcatheter Double Valve Replacement to Treat Aortic Stenosis and Severe Tricuspid Regurgitation with 3D Printing Guidance after Mechanical Mitral Valve Replacement

Background: Transcatheter treatments of tricuspid regurgitation (TR) have been emerging as alternatives for high-risk patients. In contrast to the immobilization of the common transcatheter tricuspid device, using a radial force-independent stent valve device at the native tricuspid annular site has several distinct advantages. Case summary: A 76-year-old patient with renal insufficiency who underwent mechanical mitral valve replacement in 2001 and transcatheter aortic valve replacement in 2021 due to severe aortic stenosis presented with chest pain and shortness of breath. Echocardiography suggested that the flow velocities of the mitral mechanical valve and aortic prosthetic valve were both within the normal range, with no significant paravalvular regurgitation; the tricuspid valve exhibited massive regurgitation (VMAX 258 cm/s, PGMAX 27 mmHg). Due to the high surgical risk, we simulated the procedure with a three-dimensional (3D)-printed model and performed transcatheter tricuspid valve replacement using a LuX-Valve (Ningbo Jenscare Biotechnology Co., Ningbo, China). Discussion: We describe transcatheter tricuspid valve replacement using the LuX-Valve and preprocedural guidance with 3D printing. Postprocedural TR was significantly reduced, indicating that 3D printing plays an important role in preprocedural guidance and that the LuX-Valve was safe and practicable for tricuspid valve replacement.

Safety, Efficacy and Long-Term Outcomes of Patients Treated with the Occlutech Paravalvular Leak Device for Significant Paravalvular Regurgitation.

Between December 2014 and March 2021, 144 patients with aortic (Ao) or mitral (Mi) paravalvular leaks (PVLs) were enrolled at 21 sites in 10 countries. Safety data were available for 137 patients, who were included in the safety analysis fraction (SAF), 93 patients with Mi PVLs and 44 patients with Ao PVLs. The full analysis set (FAS) comprised 112 patients with available stratum (aortic/mitral leak) as well as baseline (BL), 180-day or later assessments (2 years). Procedural success (implantation of the device with a proper closure of the PVL, defined as reduction in paravalvular regurgitation of ≥one grade as assessed by echocardiography post implantation) was achieved in 91.3% of FAS patients with Mi PVLs and in 90.0% of those with Ao PVLs. The proportion of patients suffering from significant or severe heart failure (HF), classified as New York Heart Association (NYHA) class III/IV, decreased from 80% at baseline to 14.1% at 2-year follow-up (FAS). The proportion of FAS patients needing hemolysis-related blood transfusion decreased from 35.5% to 3.8% and from 8.1% to 0% in Mi patients and Ao patients, respectively. In total, 35 serious adverse events (SAEs) were reported in 27 patients (19.7%) of the SAF population. The SAEs considered possibly or probably related to the device included device embolization (three patients), residual leak (two patients) and vascular complication (one patient). During follow-up, 12/137 (8.8%) patients died, but none of the deaths was considered to be device-related. Patients implanted with the Occlutech Paravalvular Leak Device (PLD) showed long-lasting improvements in clinical parameters, including NYHA class and a reduced dependency on hemolysis-related blood transfusions.

Patient-specific computer simulation to predict long-term outcomes after transcatheter aortic valve replacement

BackgroundPatient-specific computer simulation may predict the development of paravalvular regurgitation (PVR) after transcatheter aortic valve replacement (TAVR). We hypothesised that patient-specific computer simulation might identify patients at risk for long-term adverse outcomes after TAVR. MethodsA multi-centre retrospective study was performed on patients with symptomatic severe aortic stenosis who had undergone TAVR with a self-expanding transcatheter heart valve (THV). Pre-procedural cardiac computed tomography imaging was used to create finite element models of the aortic root. Finite element analysis (FEA) was performed in order to simulate the interaction between the THV and the native anatomy. The blood domain was extracted from the FEA output and computational fluid dynamics (CFD) simulation undertaken. Predicted PVR was recorded in the left ventricular outflow tract. Patients were classified into those where computer simulation predicted no significant PVR (predicted PVR from CFD <16.0 ​mL/s) and those where computer simulation predicted significant PVR (predicted PVR from CFD ≥16.0 ​mL/s). ResultsA total of 203 patients were included in the study. THVs implanted were CoreValve (n ​= ​20), Evolut R (n ​= ​90) and Evolut PRO (n ​= ​93). At 2 years, the Kaplan-Meier estimate of the rate of death from any cause was higher in the group where CFD simulation predicted significant PVR (35.8% vs. 16.3%; hazard ratio, 2.62; 95% confidence interval, 1.29 to 5.30; P ​= ​0.006 by log-rank test). ConclusionsComputer simulation may identify patients who are at a higher risk for death after TAVR.

Transcatheter Aortic Valve Dislocation in Left Ventricular Outflow Tract with Successful Repositioning Using “Double Snare” Technique

Background: Transcatheter aortic valve implantation (TAVI) is a widely used treatment of severe aortic stenosis. Implantation of a self-expanding valve into a dense calcified aortic annulus can be challenging and may result in device malposition and malfunction. Aim: The aim of our case report is to present a novel technique of transcatheter aortic valve dislocation treatment. Case presentation: An 86-year-old woman with severely calcified aortic valve underwent TAVI using a 27-mm self-expanding Portico valve (Abbott Vasc, USA). In the last phase of implantation, the valve dislocated deep into the left ventricular outflow tract resulting in significant paravalvular regurgitation and patient instability. Repositioning of the valve with a single snare was ineffective because of severe aortic ring calcifications. A novel “double snare” technique was applied and the valve was successfully repositioned upward with an excellent anatomic and haemodynamic result. Conclusion: “Double snare” technique can be an effective strategy for repositioning of deeply implanted self-expanding transcatheter aortic valves. It represents an efficient bailout strategy in case of single snare approach failure, especially in cases of severe aortic ring calcifications.

A novel pressure-regulated deployment strategy for improving the safety and efficacy of balloon-expandable transcatheter aortic valves

Abstract Background Annular rupture is a catastrophic complication of Transcatheter Aortic Valve Implantation, more commonly seen with balloon expandable valves. Size selection and deployment of these valves often presents a serious challenge as prosthesis oversizing increases the risk of rupture, while undersizing results in greater paravalvular regurgitation (PVR). Current deployment protocols are volume-regulated and susceptible to undesired prosthesis over or under-expansion. Laplace's Law demonstrates that the stress exerted on the aortic wall is determined by both the valve area and internal pressure during deployment. Yet the issue of balloon pressure during deployment has been thus far ignored. Purpose In this feasibility study, we aimed to develop a novel pressure-regulated deployment method that allows optimising apposition between valve and annulus, while preventing significant tissue injury and rupture. Methods We analysed a cohort of 278 consecutive patients with severe aortic stenosis and intermediate-severe surgical risk who underwent TAVI using Sapien 3 valves. This included 88 patients (32%) considered at high risk of annular rupture based on accepted factors such as moderate-severe subannular calcification. A pressure gauge was connected to the apparatus and in each case the valve was deployed until reaching a pre-determined pressure limit. In earlier cases lower pressures of 4–4.5atm were used to establish safety, while in later cases pressure limit was increased to maximum of 7atm. In some patients post-dilatation was performed to improve angiographic regurgitation. Using a biomechanical application of Laplace's Law, the estimated annular wall stress was calculated for each case and assessed against recorded complications such as annular rupture, PPM insertion, new LBBB and PVR on post-procedure TTE. Based on these analyses we then determined the optimal pressure limit for each available valve size. Results Distribution of deployment pressures and associated estimated wall stress are shown in attached Figure. 1 case of annular rupture (0.4%) occurred in high risk patient at 3.81MPa. Wall stress levels &amp;gt;3.0MPa were associated with reduced rates of post dilatation (13% vs 37%, p&amp;lt;0.001) and ≥mild PVR (10.7% vs 20%, p=0.093). In patients (148) with estimated wall stress between 3–3.8MPa rates of new PPM and LBBB were 7.4% and 8.1%, respectively. Greater wall stress was not associated with increased new PPM/LBBB risk. Therefore, we suggest the optimal deployment pressure limit to minimise risk of rupture, rates of post-dilatation and clinically significant PVR is: 6atm for 23mm valves, 5.5atm for 26mm valves and 5atm for 29mm valves. Conclusion Pressure-regulated deployment strategy is a reproducible, safe and effective method for balloon expandable TAVI, alleviating concerns of valve oversizing in high risk patients. Further trials are needed to validate this novel method and compare it with current volume-regulated techniques. Abstract Figures Funding Acknowledgement Type of funding source: None

P1458 Recurrent endocarditis on mitral valve prosthesis

Abstract Patient Presentation and initial work up A 72 years old man with history of hypertension was admitted to our hospital due to acute pulmonary oedema. He had no fever at that time and he had an history of known mitral valve prolapse but with no reported mitral valve regurgitation (MR). Transthoracic Echocardiogram (TTE) was performed and it showed a severe MR. Transesophageal echocardiogram (TOE) showed prolapse of the posterior leaflet of the mitral valve with suspicion of cordal rupture and the presence of an aneurysm of the anterior mitral valve leaflet with perforation of it (panel A and B). Diagnosis and Management Diagnosis of severe MR as the result of previous endocarditis was made. Blood cultures were negative, as well as there were no signs of active endocarditis. However, since there were heart failure and signs of uncontrolled infection, the patient underwent surgical mitral valve replacement (MVR) with bioprosthesis. Moreover, it was started antibiotic therapy with vancomycin, rifampin and ceftriaxone, which was continued for two weeks and then stopped since the microbiological culture of the valve was negative. Follow-up After two months he was re-admitted to the hospital due to a new onset of breathlessness. TTE showed a dehiscence of the mitral prosthetic valve in the inferolateral zone with rocking movement, subvalvular pseudoaneurysm and moderate paravalvular leak (panel C and D). Blood cultures were positive for Staphylococcus Aureus. Consequently, the patient underwent a new surgical MVR. Furthermore, six weeks of antibiotic therapy were carried out with daptomycin and rifampin. However, after another three months, he was admitted once again to the hospital for heart failure with a new evidence of abruption of the mitral prosthesis, again in the inferolateral region and, this time, with the evidence of a vegetation on the atrial side of the prosthesis (panel E and F). Again, blood cultures were positive for Staphylococcus Aureus, and the patient underwent the third surgical intervention of MVR. Another six weeks of antibiotic therapy with daptomycin and rifampin were performed. The patient was then discharged and he is now strictly followed clinically. Conclusion In conclusion, we reported the case of a recurrent relapse of endocarditis on mitral valve prosthesis due to Staphylococcus Aureus infection. Interestingly, the mitral prosthesis was involved always in the same zone (inferolateral area) with abruption of the prosthesis and significant paravalvular regurgitation. At the second relapse there was also a vegetation on it and both times blood cultures were positive. Moreover, antibiotic therapy was conducted for six weeks both times, but the recurrence of endocarditis showed us that he was a sensitive patient and that in cases of relapses like this it should be performed a more careful clinical follow up, involving frequent laboratory tests and clinical and echocardiographic evaluations. Abstract P1458 Figure.

P184511 years of transcatheter aortic valve implantation in a single centre and outcomes for all 1004 patient cases completed

Abstract Background Long-term outcome data after TAVI is of key importance as indications have extended from high risk patients to intermediate risk alongside contemporary study of low risk patients. Purpose We report our complete 11 y experience of TAVI. Methods All patients (n=1004) treated with TAVI in our institution between Feb 2008 &amp; Nov 2018 were included. Data was collected prospectively and all death certificates were reviewed. Independent predictors of mortality were determined by multivariable cox proportional hazard modelling. Annular sizing was performed via echocardiography +/or angiography until Aug 2012 after which time cardiac CT was used. Results Patients were 53% female &amp; had mean age 81.9±6.6 y, logistic EuroScore 18.5%. 89% were NYHA &gt;2, and 26.7% had a left ventricular ejection fraction (LVEF) of &lt;50%. TAVI was performed for severe degenerative aortic valve disease (93.5%), while valve-in-valve (2.4%) bicuspid (2.1%) &amp; rheumatic (2%) made up the remainder. Self-expanding valves were implanted in 73% cases. 98% cases were performed under local anaesthesia. A percutaneous transfemoral approach was used in 92% cases. For the first 6 y 19% procedures were performed for urgent inpatients, rising to 42% over the last 5 y. The mean time to discharge was 5.5 d, overall, &amp; 60% cases were discharged within 72 h in the last 5 y. Mortality, for those at risk, was 3.2%, 12.8%, 53% &amp; 88% at 30 d, 1 y, 5 y &amp; 10 y. The median time to death was 2.6 y. Non-cardiac death accounted for 62% deaths, with sepsis being the main cause (55%). The main cause of cardiac death was heart failure (HF (53%)). Independent clinical predictors of death were increased age, atrial fibrillation, pulmonary disease &amp; LVEF &lt;50%. Use of a 2nd generation valve was associated with better survival at 5 y (p&lt;0.001). 30 d new permanent pacemaker and stroke incidence were 13.7% and 2% respectively. 30 d readmission occurred in 13% patients. Independent clinical predictors of 1 y HF (7%) readmission were NYHA Class &gt;2 and LVEF &lt;50%. Endocarditis was seen in 1.6% during a mean follow-up 2,593 patient y. Mean aortic gradients at 1 y, 5 y &amp; 10 y were 9.7mmHg, 8.4mmHg &amp; 10.53mmHg. One patient had severe trans-aortic regurgitation during the follow-up. A 2nd TAVI procedure was performed in 5 patients with clinically significant paravalvular regurgitation, all within 30 d. Figure 1. A. Survival. B. Predictors death Conclusion This comprehensive evaluation of all patients treated with this innovative technology provides reassurance regarding the long-term clinical efficacy of TAVI &amp; gives insight into the evolution of our programme with time.

Time-Integrated Aortic Regurgitation Index Helps Guide Balloon Postdilation During Transcatheter Aortic Valve Replacement and Predicts Survival.

BackgroundBalloon postdilation (BPD) has emerged as an effective strategy to reduce paravalvular regurgitation (PVR) during transcatheter aortic valve replacement (TAVR). We investigated the utility of a time‐integrated aortic regurgitation index (TIARI) to guide balloon postdilation (BPD) after valve deployment.Methods and ResultsAll consecutive patients who had echocardiography, aortography, and hemodynamic tracings recorded immediately after valve deployment during TAVR were included in the study. Catheter‐derived invasive hemodynamic parameters were calculated offline. Among 157 patients who underwent TAVR, 49 (32%) patients required BPD to reduce significant PVR after valve deployment. Two experienced operators decided whether the patients required BPD for significant PVR. Median TIARI measured immediately after valve deployment was significantly lower in patients who required BPD when compared with patients who did not require BPD (P<0.001). In a multivariable analysis, lower TIARI (odds ratio: 0.81; P=0.003) and higher PVR grade on aortography and echocardiography (P<0.001 for both) were associated with BPD. Adding TIARI to echocardiography and aortographic PVR assessment resulted in a significant increase in global χ2 (P<0.001), an integrated discrimination index of 9% (P=0.002), and combined C‐statistics of 0.99 for predicting BPD. Higher TIARI after valve deployment was associated with better survival (hazard ratio: 0.94, P=0.014), while other hemodynamic and imaging parameters did not predict mortality after TAVR.ConclusionsAmong patients undergoing TAVR, a TIARI measured immediately after valve deployment adds incremental value to guide BPD over aortography and echocardiography. Higher residual TIARI is associated with better survival after TAVR.

A New Three-Dimensional Echocardiography Method to Quantify Aortic Valve Calcification

Aortic valve calcification (AVC) quantification is computed from multidetector computed tomography (MDCT). The aim of this study was to test the hypothesis that three-dimensional (3D) transthoracic echocardiography can be used to provide a bedside method to assess AVC. The study included 94 patients (mean age, 78±12years; mean aortic valve [AV] area, 1.0±0.6cm2) referred for MDCT and echocardiography for AV assessment. Apical 3D full-volume data sets focused on the AV region were acquired during transthoracic echocardiography, and a region-growing algorithm was applied offline to compute 3D transthoracic echocardiographic AVC (AVC-3DEcho). AVC-3DEcho was compared with AVC by MDCT and with calcium weight in the subgroup of patients referred for surgery, with explanted AVs analyzed by a pathologist (n=22). In the explanted valve group, AVC-3DEcho score exhibited fair correlations with MDCT score (r=0.85, P<.001), calcium load (r=0.81, P<.001), and peak AV velocity (r=0.64, P<.001). In the overall population, AVC-3DEcho score correlated modestly with MDCT score (r=0.61, P<.001) but had similar accuracy to identify severe aortic stenosis (area under the curve=0.94). AVC-3DEcho > 1,054mm3 identified severe aortic stenosis with specificity of 100% and sensitivity of 76%. In addition, AVC-3DEcho was associated with the presence of significant paravalvular regurgitation after transcatheter aortic valve implantation. Finally, intraobserver and interobserver variability for AVC-3DEcho score was 4.2% and 8.9%, respectively. AVC-3DEcho correlated with calcium weight obtained from pathologic analysis and MDCT. These data suggest that a bedside method for quantifying AV calcification with ultrasound is feasible.

Aortic valve and left ventricular outflow tract calcium volume and distribution in transcatheter aortic valve replacement: Influence on the risk of significant paravalvular regurgitation

ObjectivesWe sought to determine the impact of aortic root calcium on the risk of significant paravalvular regurgitation (sPAR) in transcatheter aortic valve replacement (TAVR). MethodsIn 302 consecutive patients from 3 centers, aortic root calcium was quantified volumetrically on pre-TAVR multidetector computed tomography (MDCT) in three regions: 1) the aortic valve region, 2) the overall left ventricular outflow tract (LVOT) and 3) the upper LVOT. Transcathether heart valve (THV) oversizing was calculated as (THV nominal area/MDCT annular area−1) × 100. The study endpoint sPAR was a composite of post-dilatation (PD) and PAR > mild. ResultssPAR occurred in 15% (46/302) of patients. Upper LVOT calcium volume was more predictive of sPAR than overall LVOT calcium volume, with an area under the receiver operating curve (AUC) (95% confidence interval [CI]) of 0.80 (0.67–0.89) vs. 0.60 (0.51–0.70); p = 0.0001. The optimal cut-off calcium volume thresholds determined from receiver operating curves were 21 mm3 and 30 mm3 for upper LVOT and overall LVOT calcium, respectively. Upper LVOT calcium ≥ 21 mm3, but not overall LVOT calcium ≥ 30 mm3, independently predicted sPAR, odds ratio (95%CI): 9.5 (4.1–22.3) vs 1.6 (0.6–2.7). Upper LVOT calcium was more predictive of sPAR in patients with THV oversizing ≥ 13% compared to patients with THV oversizing <13%, AUC (95% CI): 0.83 (0.72–0.93) vs. 0.67 (0.51–0.74); p < 0.0001. ConclusionsUpper LVOT calcium predicts more-than-mild paravalvular regurgitation following TAVR or the need for postdilatation. Upper LVOT calcium is most predictive of paravalvular regurgitation in the event of THV oversizing ≥ 13%.

Pressure-Regulated Deployment of Balloon Expandable Transcatheter Aortic Valves: A Novel Approach to Valve Expansion

Annular rupture is a devastating complication of transcatheter aortic valve implantation. The risk of rupture increases with prosthesis oversizing and subannular calcification. Conversely, under expanding valves to reduce risk of rupture increases the likelihood of paravalvular regurgitation, which is associated with poor long-term outcomes. Current deployment techniques are volume regulated and estimate prosthesis cross sectional area, based upon the volume to which a deployment balloon is filled. However, arterial wall tension is determined by both inflation pressure and balloon diameter, as demonstrated by Laplace's Law where: Hoop stress = Pressure × Diameter. Therefore, avoiding high pressures during valve deployment should reduce wall tension and risk of rupture. This study evaluated the safety and feasibility of deploying balloon-expandable transcatheter heart valves in a pressure-regulated manner. Valves were deployed between 4–5 atm, which resulted in residual volumes within the deployment syringe. Ninety-nine patients were included: 52 received valves deployed at 4 atm. Of these, 44% required postdilatation balloon aortic valvuloplasty (BAV), a surrogate marker for significant paravalvular regurgitation. In contrast, 41 patients received valves deployed between 4.5–5 atm and 24% required postdilatation BAV. This suggests that deployment at ≥4.5 atm significantly reduces paravalvular regurgitation after the initial deployment (p = 0.047). This cohort included 30 patients who received valves that would have been oversized by >20% if deployed at nominal volume, and 18 patients with moderate-severe subannular calcification. No patient experienced annular rupture. Thus, using pressure-limited technique it was demonstrated that safe deployment is possible, even in patients who are at high risk of annular rupture.

Quantified degree of eccentricity of aortic valve calcification predicts risk of paravalvular regurgitation and response to balloon post-dilation after self-expandable transcatheter aortic valve replacement

BackgroundLimited data exist regarding the impact of aortic valve calcification (AVC) eccentricity on the risk of paravalvular regurgitation (PVR) and response to balloon post-dilation (BPD) after transcatheter aortic valve replacement (TAVR). We investigated the prognostic value of AVC eccentricity in predicting the risk of PVR and response to BPD in patients undergoing TAVR. MethodsWe analyzed 85 patients with severe aortic stenosis who underwent self-expandable TAVR (43 women; 77.2±7.1years). AVC was quantified as the total amount of calcification (total AVC load) and as the eccentricity of calcium (EoC) using calcium volume scoring with contrast computed tomography angiography (CTA). The EoC was defined as the maximum absolute difference in calcium volume scores between 2 adjacent sectors (bi-partition method) or between sectors based on leaflets (leaflet-based method). ResultsTotal AVC load and bi-partition EoC, but not leaflet-based EoC, were significant predictors for the occurrence of ≥moderate PVR, and bi-partition EoC had a better predictive value than total AVC load (area under the curve [AUC]=0.863 versus 0.760, p for difference=0.006). In multivariate analysis, bi-partition EoC was an independent predictor for the risk of ≥moderate PVR regardless of perimeter oversizing index. The greater bi-partition EoC was the only significant parameter to predict poor response to BPD (AUC=0.775, p=0.004). ConclusionPre-procedural assessment of AVC eccentricity using CTA as “bi-partition EoC” provides useful predictive information on the risk of significant PVR and response to BPD in patients undergoing TAVR with self-expandable valves.

Transcatheter Aortic Valve Implantation In Patients With a Large Aortic Annulus

As the indications for transcatheter aortic valve implantation (TAVI) have expanded, so to have the demands on interventionists to allow as many patients to access this technology as possible. We retrospectively reviewed our TAVI database for patients who had received a 29mm SAPIEN 3 valve despite having an annular area greater than the manufacturer-recommended upper limit of 683mm2, as determined by multi-detector computed tomography (MDCT). Procedural and inpatient outcome data were collected. The study population was 5 of 121 patients receiving a SAPIEN 3 valve since it became available in March 2015. Their annular area ranged from 691 to 800mm2. Valve deployment was successful in all patients. The deployment balloon volume was nominal, except for an additional 1ml in one patient. No patient had a new indication for permanent pacing, and no significant valvular or paravalvular regurgitation (PVR) was identified on post-procedure transthoracic echocardiography. All patients survived to hospital discharge. In this select group of patients we have demonstrated that it is safe and feasible to use the 29mm SAPIEN 3 in patients with annular dimensions greater than those recommended, with minimal balloon overfilling.

A systematic review of reported cases of combined transcatheter aortic and mitral valve interventions.

To summarize the published data of combined transcatheter aortic and mitral valve intervention (CTAMVI). CTAMVI, a combination of either transcatheter aortic valve replacement (TAVR) or transcatheter aortic valve-in-valve (TAViV) and transcatheter mitral valve replacement (TMVR), transcatheter mitral valve-in-valve/valve-in-ring (TMViV/ViR), or percutaneous mitral valve repair (PMVR) is an attractive alternative in high-surgical risk patients with combined aortic and mitral valve disease. However, its procedural details and clinical outcomes have not been well described. We performed a systematic review of all the published articles from PUBMED and EMBASE. A total of 37 studies with 60 patients were included. The indication for CTAMVI was high or inoperable surgical risk and symptomatic severe aortic stenosis (92%) or severe aortic regurgitation (8%) combined with moderate to severe/severe mitral stenosis (30%) or moderate/severe mitral regurgitation (65%) or both (5%). In majority of the cases, aortic valve intervention was performed prior to the mitral valve. Mortality rate were 25% for TAVR + TMVR (range 42 days to 10 months), 17% for TAVR + TMViV/ViR (range 13 days to 6 months), 0% for TAViV + TMViV/ViR (range 6-365 days), and 15% for TAVR/ViV + PMVR (range 17 days to 419 days). Significant (more than moderate) paravalvular regurgitation post-procedure was rare. CTAMVI appears to confer reasonable clinical outcome. Further large study is warranted to clarify the optimal strategy, procedural details and clinical outcomes in the future.

Comparison of outcomes in new-generation versus early-generation heart valve in transcatheter aortic valve implantation: A systematic review and meta-analysis.

New-generation (NG) valves for transcatheter aortic valve implantation (TAVI) has recently been widely used in real-world practice, yet its comparative outcomes with early-generation (EG) valves remain under-explored. An electronic literature search using PUBMED and EMBASE was conducted from inception to April 2017 for matched-cohort studies. Articles that compared the outcomes of NG vs. EG valves post TAVI with at least one of the following clinical outcome reported were included: all-cause mortality, major or life-threatening bleeding, major vascular complications (MVC), significant (more than moderate) paravalvular regurgitation (PVR), cerebrovascular events, significant (stage 2 or 3) acute kidney injury (AKI) and new permanent pacemaker implantation (PPI) that occurred either in-hospital or within 30-days. A total of 6 observational matched-cohort studies with 585 and 647 patients included in NG and EG valves, respectively, were included. EG valves were associated with a lower incidence of major or life-threatening bleeding (5.7% vs. 15.7%, p<0.00001), significant paravalvular regurgitation (5.3% vs. 14.4%, p=0.001), and significant AKI (4.4% vs. 7.5, p=0.03). All-cause mortality (3.5% vs. 5.0, p=0.43), cerebrovascular events (3.4% vs. 2.3%, p=0.34) and new PPI (11.0% vs. 14.6%, p=0.52) were similar between the two groups. NG demonstrated lower tendency of MVC (2.5% vs. 7.2, p=0.09) compared to EG valves. NG demonstrated lower rates of significant AKI, significant PVR and major or life-threatening bleeding while all-cause mortality, new PPI, and cerebrovascular events remained similar compared to EG valves.

Contemporary transcatheter aortic valve replacement with third-generation balloon-expandable versus self-expanding devices.

To evaluate balloon-expandable and self-expanding third-generation transcatheter aortic valve replacement (TAVR) devices according to patient selection criteria and outcomes. Two competing third-generation TAVR technologies are currently commercially available in the US. There are no published head-to-head comparisons of the relative performance of these two devices. 257 consecutive patients undergoing TAVR with a third-generation balloon-expandable (Edwards Sapien 3) or self-expanding device (Medtronic CoreValve Evolut R) at a single US medical center were included. Choice of TAVR device was at the discretion of the multidisciplinary Heart Team. Baseline clinical characteristics, echocardiographic and CT imaging, procedural and 30-day outcomes were prospectively collected. 74 patients received a self-expanding valve (SEV) and 183 received a balloon-expandable valve (BEV). Patients selected for SEV were more frequently women, with lower body surface area and smaller calcified iliofemoral arteries. Three SEV patients required implantation of a second valve to successfully treat paravalvular leak. Only one BEV patient had moderate paravalvular regurgitation. There was no difference in the rate of stroke, major vascular complication or bleeding. Permanent pacemaker implantation rate was significantly higher with SEV (12.7% vs 4.7%, P = 0.49) and hospital length of stay was longer (8.3% vs 6.5%, P = 0.043), but 30-day mortality was comparable (1.4% vs 1.6%, P = 1.00). Short-term outcomes were equivalent between the two technologies. Clinically significant paravalvular regurgitation was rare. SEV were more frequently selected in women and patients with challenging transfemoral access, but were associated with higher permanent pacemaker implantation rate and longer hospital length of stay.

Safety and Efficacy of Transcatheter Aortic Valve Replacement in the Treatment of Pure Aortic Regurgitation in Native Valves and Failing Surgical Bioprostheses: Results From an International Registry Study

ObjectivesThe aim of this study was to evaluate the use of transcatheter heart valves (THV) for the treatment of noncalcific pure native aortic valve regurgitation (NAVR) and failing bioprosthetic surgical heart valves (SHVs) with pure severe aortic regurgitation (AR). BackgroundLimited data are available about the “off-label” use of transcatheter aortic valve replacement (TAVR) to treat pure severe AR. MethodsThe study population consisted of patients with pure severe AR treated by TAVR at 18 different centers. Study endpoints were device success, early safety, and clinical efficacy at 30 days, as defined by Valve Academic Research Consortium 2 criteria. ResultsA total of 146 patients were included, 78 patients in the NAVR group and 68 patients in the failing SHV group. In the NAVR group, device success, early safety, and clinical efficacy were 72%, 66%, and 61%, respectively. Device success and clinical efficacy were significantly better with newer generation THVs compared with old-generation THVs (85% vs. 54% and 75% vs. 46%, respectively, p < 0.05); this was mainly due to less second THV implantations and a lower rate of moderate to severe paravalvular regurgitation (10% vs. 24% and 3% vs. 27%, respectively). Independent predictors of 30-day mortality were body mass index <20 kg/m2, STS surgical risk score >8%, major vascular or access complication, and moderate to severe AR. In the failing SHV group, device success, early safety, and clinical efficacy were 71%, 90%, and 77%, respectively. ConclusionsTAVR for pure NAVR remains a challenging condition, with old-generation THVs being associated with THV embolization and migration and significant paravalvular regurgitation. Newer generation THVs show more promising outcomes. For those patients with severe AR due to failing SHVs, TAVR is a valuable therapeutic option.

Next-Generation Transcatheter Aortic Valve Replacement (TAVR) Clinical Outcomes in Low-Intermediate Risk Patients: Large Single-Centre Experience

Background: TAVR is an established option for high surgical risk patients with severe aortic stenosis. There are limited data on clinical outcomes with next generation TAVR devices (Lotus and Evolut R) in low-intermediate risk patients. Methods: Consecutive patients with STS mortality score <8% who underwent transfemoral TAVR with the Lotus Valve and Evolut R systems were included. Outcomes were assessed in accordance with VARC-2 criteria. Results: 190 patients were analysed (mean age 83.6 years and STS score 3.83%). Baseline characteristics were similar. Clinical outcomes of device success, death and stroke were similar. The Lotus Valve had lower rates of valve-in-valve and significant (moderate or greater) paravalvular regurgitation (PVR). Conclusion: Next-generation TAVR systems perform well in low-intermediate surgical risk patients. While the Lotus Valve has lower rates of valve-in-valve and significant PVR, both devices have acceptable clinical outcomes.