Mild Paravalvular Aortic Regurgitation Research Articles

Impact of different degrees of computed tomography-based oversizing on clinical outcomes after transcatheter aortic valve implantation using the Portico system.

The study aimed to evaluate the influence of different degrees of multidetector computed tomography (MDCT)-based perimeter oversizing on incidence and severity of paravalvular aortic regurgitation (PAR) and conduction disturbances (CD) for the Portico device. We retrospectively analyzed 63 patients who underwent transcatheter aortic implantation (TAVI) in our center from March 2017 to June 2019. Patients were divided into two groups (group I, below %13.9; group II, above 13.9%) based on the degree of oversizing. Oversizing was calculated as (Device nominal perimeter / MDCT-derived annular perimeter - 1) * 100. Procedural and clinical data were evaluated by VARC-2 definitions. Mild or greater PAR was present in 76.4% of patients in group I and 34.4% of patients in group II (P = 0.009). The rate of CD tended to be lower in the patient's group I (P = 0.034). A cutoff value of 13.9% was identified as having the best predictive value for mild or greater PAR. On multivariate analysis, a lower percentage of oversizing (odds ratio 6.38; %95 confidence interval 2.00 - 20.33; P = 0.002) emerged as the most powerful independent predictor of PAR, whereas the implantation depth and severe oversizing were independent predictors of CD (P = 0.003 and P = 0.029, respectively). We demonstrated that the optimal acceptable perimeter-based oversizing range appears to be between 10 - 15%. Perimeter-based oversizing by MDCT inversely correlated with PAR after TAVI for Portico device, and its preoperative evaluation could help in predicting PAR and CD.

Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement

BackgroundThere are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk.MethodsWe enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke.ResultsAt 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P=0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery.ConclusionsAmong patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.)

The Influence of Aortic Pulse Wave Velocity on Short-Term Functional Capacity in Patients with Mild Paravalvular Regurgitation Following Transcatheter Aortic Valve Implantation.

IntroductionRecently, the clinical significance of mild paravalvular aortic regurgitation (PAR) has been evaluated and suggested that it can be predictor of clinical outcomes. In our study, we aimed to investigate the interaction of aortic pulse wave velocity (PWV) and mild PAR and their effects on the functional status of patients after transcatheter aortic valve implantation (TAVI).MethodsA total of 109 consecutive patients with symptomatic severe aortic stenosis were enrolled prospectively. After TAVI procedure, they were divided in to three groups according to PAR and PWV measurements. Patients without PAR were defined as the NonePAR group (n=60), patients with mild PAR and normal PWV were defined as the MildPAR-nPWV group (n=23), and patients with mild PAR and high PWV were defined as the MildPAR-hPWV group (n=26).ResultsCompared with other groups, the MildPAR-hPWV group was older (P<0.001), hypertensive (P=0.015), and had a higher pulse pressure (P=0.018). In addition to PWV, this group had lower aortic regurgitation index (ARI) (P=0.010) and higher rate of New York Heart Association (NYHA) class II (at least) patients (P<0.001) in 30-day follow-up period. On multivariate regression analysis, the MildPARhPWV group (odds ratio=1.364, 95% confidence interval 1.221-1.843; P=0.011) as well as N-terminal-pro-brain natriuretic peptide levels and ARI were independently related with 30-day functional NYHA classification. However, NonePAR or MildPAR-nPWV group was not an independent predictor of early functional status.ConclusionIt was concluded that high PWV may adversely affect early functional status in patients with mild PAR in contrast to normal values following TAVI.

Mid-Term Outcomes of Transcatheter Aortic Valve Replacement in Extremely Large Annuli With Edwards SAPIEN 3 Valve

ObjectivesThe aim of this study was to report the 1-year results of transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli. BackgroundFavorable 30-day outcomes of S3 TAVR in annuli >683 mm2 have previously been reported. Pacemaker implantation rates were acceptable, and a larger left ventricular outflow tract and more eccentric annular anatomy were associated with increasing paravalvular leak. MethodsFrom December 2013 to December 2018, 105 patients across 15 centers with mean area 721.3 ± 36.1 mm2 (range 683.5 to 852.0 mm2) underwent TAVR using an S3 device. Clinical, anatomic, and procedural characteristics were analyzed. One-year survival and echocardiographic follow-up were reached in 94.3% and 82.1% of patients, respectively. Valve Academic Research Consortium-2 30-day and 1-year outcomes were reported. ResultsThe mean age was 76.9 ± 10.4 years, and Society of Thoracic Surgeons predicted risk score averaged 5.2 ± 3.4%. One-year overall mortality and stroke rates were 18.2% and 2.4%, respectively. Quality-of-life index improved from baseline to 30 days and at 1 year (p < 0.001 for both). Mild paravalvular aortic regurgitation occurred in 21.7% of patients, while moderate or greater paravalvular aortic regurgitation occurred in 4.3%. Mild and moderate or severe transvalvular aortic regurgitation occurred in 11.6% and 0%, respectively. Valve gradients remained stable at 1 year. ConclusionsS3 TAVR in annular areas >683 mm2 is feasible, with favorable mid-term outcomes.

Modified implantation height of the Sapien3™ transcatheter heart valve

Objectives: During transcatheter aortic valve implantation (TAVI), ideal positioning is crucial. The latest-generation balloon expandable Sapien3™ transcatheter heart valve (THV) comes with a marker, which is recommended to be exactly centered at the aortic annular level. We aimed to evaluate a higher “aortic” marker positioning.Material and methods: A total of 119 high-risk patients presenting with aortic stenosis were treated with the Sapien3™ THV. After having placed the THV more “aortic”, clinical and hemodynamic data, especially postoperative pacemaker implantation and paravalvular leakages, were evaluated at 30-days according to VARC-2.Results: The Sapien3™ THV was implanted in 92 patients via the transapical, in 13 patients via the transaortic and in 14 patients via the tranfemoral access. Mean age was 80.6 ± 5.7 years. Aortic valve area increased significantly (0.9 ± 0.3 vs. 1.80 ± 0.35cm2, p < .0001) and mean pressure gradients decreased from 41.0 ± 15.0 to 10.4 ± 3.5 mmHg (p < .0001). The majority of patients showed no or mild paravalvular aortic regurgitation (99.1%, 112/113), confirmed by transthoracic echocardiography at 30-days: PVL was absent or trace in 91.2% (103/113), mild in 7.9% (9/113) and moderate in 0.9% (1/113), whereas no patient developed severe PVL. Thirty days mortality was 5.0% (6/119). All patients (n = 113) were in NYHA functional class I or II at 30 days and three patients (2.5%) needed pacemaker implantation.Conclusions: In conclusion, a modified higher “aortic” implantation of the Sapien3™ THV holds promise to further reduce paravalvular leakage as well as permanent pacemaker implantation in TAVI. This trial showed an extremely low postoperative pacemaker implantation rate of 2.5%.

Computed tomography-based oversizing and incidence of paravalvular aortic regurgitation and permanent pacemaker implantation with a new-generation self-expanding transcatheter heart valve.

We aimed to evaluate the relationship between CT-based annular perimeter oversizing and the incidence of paravalvular aortic regurgitation (PAR) and permanent pacemaker (PPM) implantation in patients treated with the new self-expanding CENTERA transcatheter heart valve (THV) for severe aortic stenosis. One hundred and ninety-eight patients in the CENTERA-EU trial were stratified a priori into four groups based on the perimeter oversizing (2.5-10%, 10-15%, 15-20% and >20%). PAR at 30 days was moderate or higher in 0.6% of patients. The frequency of PPM implantation was 4.9%. The mean perimeter oversizing was 16.2±5.6%. For patients with a perimeter oversizing >10%, an inverse relationship between oversizing and ≥mild PAR was observed (43.3% for 10-15% oversizing; 37.7%, 15-20%; 33.3%, >20%). No association between oversizing and effective orifice area was observed. The optimal cut-off value of perimeter oversizing for the prediction of ≥mild PAR was 15.9% (AUC 0.718, 95% CI: 0.576, 0.860). No annular ruptures were observed. The CENTERA THV appears to have a wide range of sizing tolerance. The degree of oversizing to mitigate PAR is relatively low compared to other self-expanding transcatheter devices. There appears to be no compromise between occurrence of PAR and PPM across this wide range of oversizing.

Balloon sizing during transcatheter aortic valve implantation

Although balloon sizing has been found to be useful during transcatheter aortic valve implantation (TAVI), its effectiveness in patients with bicuspid aortic valve (BiAV) remains unknown. Patients who underwent balloon sizing were retrospectively identified. The study comprised 67patients (61.2% with BiAV). Preprocedural hypothetical transcatheter heart valve (THV) sizing was based on multislice computed tomography (MSCT) measurements at the annulus. Changes in valve size after balloon sizing were reviewed. Postprocedural MSCT measurements and the grade of paravalvular aortic regurgitation (PAR) were compared. When comparing patients with aBiAV and those with atricuspid aortic valve (TiAV), there was no significant difference (p = 0.97) in the proportion of decreased (43.9% vs. 46.2%), unchanged (51.2% vs. 50.0%), or increased (4.9% vs. 3.8%) valve sizes chosen on the basis of MSCT findings. The anticipated annular sizing ratio for patients who received asmaller valve was 7.2% (3.5-10.5%) while it was 15.7% (12.5-19.0) for the others (p < 0.01), and no significant difference in the proportion of mild (or more severe) PAR cases was found between the groups (37.9% vs. 30.6%, p = 0.53 at the 1‑month follow-up). Stent frame expansion and eccentricity index were comparable between the BiAV and TiAV subgroups among patients who received asmaller THV after balloon sizing. Balloon sizing is auseful tool that is complementary to the current gold standard of MSCT for THV size selection as well as for BiAV morphology assessment.

Abstract 21395: The One-Stop Trans-Apical Device for Aortic Valvular Disease: 1-Year Results of the Multi-Centre Study on J-Valve System

Objectives: This study presents the first report of multi-centre outcomes of the J-Valve TM system with a novel designed positioning element and a two-step positioning mechanism for easy and accurate implantation in patients with AS or AR. Methods: This multi-centre, prospective study, conducted at three largest cardiac centers in China, enrolled 107 patients (mean age 74.4 ± 5.18). Preoperative Euro-SCORE was (27.5 ± 8.3%). Clinical and echocardiographic evaluations were performed at baseline, post-procedure, discharge and 30 days, and also at 6 and 12 months. Results: TA-TAVI with the J-Valve device was successfully implanted in 98 patients (procedural success rate 93.33%). The overall mortality at 30 days and 12months was 4.7% and 5.0% respectively. Conversion to surgery was necessary in 6 patients (5.6%). Among 58 patients with AS, 12-month follow-up echocardiography demonstrated a favorable reduction of mean transvalvular gradients from 51±17 mmHg to 15±8 mmHg. All patients with completed follow up (n=93) reported improvements in at least one of the NYHA classes. The majority of successfully treated patients remained no or mild paravalvular aortic regurgitation (98.7%); none of the patients had severe post-procedural regurgitation (&gt;2+). The combined ratio of successful implantation without adverse events at 1-year was 85.0%. Conclusions: Transapical J-ValveTM implantation was safe and effective in the treatment of patients with AS or AR at high risk for surgery. Excellent hemodynamic performance during the one year follow-up was demonstrated with low incidence of post-operative complications.

SELECTIVE STRATEGY USING BALLOON-EXPANDABLE VERSUS SELF-EXPANDING TRANSCATHETER AORTIC VALVE PROSTHESIS TO MINIMIZE PARAVALVULAR AORTIC VALVE REGURGITATION

More than mild paravalvular aortic regurgitation (PAR) after transcatheter aortic valve implantation (TAVI) is associated with increased morbidity and mortality. Aortic valve prosthesis sizing by multidetector computed tomography (MDCT) 3-dimensional aortic annular dimensions reduces the incidence of PAR. We hypothesize that MDCT based aortic annular dimensions based strategy selecting balloon expandable (BE) vs. self expanding (SE) aortic valve prosthesis may further reduce the incidence of PAR. We started our TAVI program using BE valves only (Group 1, n=78) with MDCT based aortic annular sizing. We identified that aortic annulus ellipticity ratio (the ratio of the shortest and longest diameter of the aortic annulus) and the degree of aortic prosthesis oversizing [100 × (Prosthetic valve area - aortic annular area) / prosthetic valve area] independently predicted more than mild PAR. In second phase of our TAVI program we used both BE and SE prosthesis. We postulated that a SE prosthesis may conform to the contours of aortic annulus with higher degree of oversizing (DOS), though with less radial force, thereby minimizing risk of annular rupture. We adopted a preferred strategy of using SE prosthesis with aortic annulus ellipticity ratio (AAER) of < 0.7. Group 2 (n=82) comprised of 51 (62.2%) BE valves and 31 (37.8%) SE valves. PAR was assessed by transthoracic echocardiogram done within 30 days of TAVI procedure. In Group 1 with BE valves, AAER of < 0.7 was present in 12.8% of patients with multivariate analysis showing AAER (p=0.02) and DOS (p=0.005) independently predicting PAR. In Group 2 with selective use of BE and SE valves (n=82), AAER was present in 9.8% of patients. None of the patients with BE valves (n=51) had AAER < 0.7 vs. those with SE valves (n=31) AAER < 0.7 was present in 25.8% of patients (p< 0.001). DOS was 11.6% with BE valves and 19.5% with SE valves (p < 0.001). The incidence of more than mild PAR was 12.8% in Group 1. With selective strategy in Group 2 there was no patient with more than mild PAR at 30 days. Subgroup analysis showed similar results for second and third generation BE valves. Selective strategy of using SE valves based on AAER of < 0.7 and careful oversizing of prosthesis was associated with marked reduction in PAR at 30 days. The reduction in PAR is expected to improve clinical outcomes.

Comparison of valve performance of the mechanically expanding Lotus and the balloon-expanded SAPIEN3 transcatheter heart valves: an observational study with independent core laboratory analysis.

The Lotus and SAPIEN3 are second-generation transcatheter heart valves, which are designed to minimize paravalvular aortic regurgitation (PAR) after transcatheter aortic valve replacement (TAVR). We sought to compare both devices for valve performance and with emphasis on PAR by independent core laboratory analysis. A total of 162 (79 Lotus and 83 SAPIEN3) consecutive patients (51% female, 80 ± 8 years, Logistic EuroSCORE 14.8 ± 9.4%) who underwent TAVR because of aortic stenosis were included. Patients with aortic valve-in-valve treatment were excluded. Pre-discharge echocardiograms were analysed by an independent core laboratory using the Valve Academic Research Consortium 2 criteria. There were no differences in baseline and procedural characteristics, except for a larger aortic annulus and sizing indices in SAPIEN3-treated patients and frequency of post-dilatation (0% in Lotus and 13.1% in SAPIEN3). Both valves have similar mean residual gradient, indexed effective orifice area and Doppler velocity index when adjusted to valve size. The frequency of mild (13.9% vs. 31.3%) and at least moderate (1.3% vs. 3.6%) PAR was less after Lotus than after SAPIEN3 implantation (P = 0.02). Multi-slice computed tomography-based annulus and left ventricular outflow tract diameters, calcification and percentage of oversizing were not different between those with or without mild or more PAR. On multivariate analysis, the use of Lotus valve was associated with less (odds ratio OR, 0.41, P = 0.03) occurrence of PAR. Overall, haemodynamic performance was comparable between the Lotus and SAPIEN3 valves. Lotus valve required less oversizing and was associated with less PAR than SAPIEN3.

Impact of paravalvular aortic regurgitation after transcatheter aortic valve implantation on survival

ObjectivesTo determine whether ≥moderate paravalvular aortic regurgitation (PAR) after transcatheter aortic valve implantation (TAVI) independently impairs overall survival and how much the impact on survival is, we performed an updated meta-analysis pooling not unadjusted but adjusted hazard ratios (HRs). MethodsDatabases including MEDLINE and EMBASE were searched through January 2016 using PubMed and OVID. Search terms included paravalvular or perivalvular; regurgitation, leak, or leakage; percutaneous, transcatheter, transluminal, transarterial, transapical, transaortic, transcarotid, transaxillary, transsubclavian, transiliac, transfemoral, or transiliofemoral; and aortic valve. Studies considered for inclusion met the following criteria: the design was an observational comparative study; the study population was patients undergoing TAVI; patients were divided into ≥moderate and ≤mild post-TAVI PAR; outcomes included ≥1-year all-cause mortality; and the adjustment method was a multivariate Cox proportional hazards analysis. An adjusted HR with its 95% confidence interval (CI) for ≥moderate post-TAVI PAR was abstracted from each individual study. ResultsOur search identified 17 eligible studies including a total of 15,131 patients. A pooled analysis of all the 17 studies demonstrated a statistically significant 2.12-fold increase in mortality with ≥moderate PAR (HR, 2.12; 95% CI, 1.79 to 2.51; p<0.00001). Exclusion of any single study from the meta-analysis did not substantively alter the overall result disfavoring ≥moderate PAR. Although the statistical tests suggested funnel plot asymmetry, the corrected effect estimate from the trim-and-fill method demonstrated still a statistically significant 1.83-fold risk of mortality with ≥moderate PAR. Conclusions≥Moderate post-TAVI PAR is associated with a 2.12-fold increase in overall (≥1-year) all-cause mortality.

0345: Thirty-day outcomes of transcatheter aortic valve implantation with the latest generation Edwards SAPIEN 3 prosthesis via the transiliofemoral approach

Few data is available concerning the latest generation Edwards SAPIEN 3- S3 in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI). To evaluate periprocedural and 30-day clinical outcomes of TAVI using the Edwards SAPIEN 3 prosthesis) via transiliofemoral approach. Between September 2014 and March 2015, consecutive high-risk or non-operable patients with severe aortic stenosis had TAVI using Edwards SAPIEN 3 prosthesis in Institut Mutualiste Montsouris. Valve Academic Research Consortium endpoints were used. Of 142 patients who underwent TAVI using Edwards SAPIEN prosthesis, 66 were treated with SAPIEN 3 via transfemoral access (mean age 84±7.1 years; 70% female). About 65% and 48% of patients had, respectively, severe peripheral artery diseases and calcified iliofemorale arteries. Multi-detector computed tomography estimated an aortic annular diameter of 25,07±2mm. Mean logistic EuroSCORE was 15,8±10,8. The device success rate was 98.5%. No failure of valve deployment had occurred and no patient had more than mild paravalvular aortic regurgitation. Mean transaortic gradient decreased from 46, 0±12,33mmHg to 8,2±3,37mmHg (p<0,001), at 30 days follow up, there were no myocardial infarction. The major bleedings rate was 1.5%, and 6% of patients required transfusion. The major vascular complications were 6%, mortality and stroke were of 3%, and the rate for a new pacemaker was 10,6. In our study, TAVI with Edwards SAPIEN 3 was associated with a high rate of device success and low rate of paravalvular aortic regurgitations and major bleedings.

Value of CMR in quantification of paravalvular aortic regurgitation after TAVI.

To assess the value of cardiac magnetic resonance (CMR) using phase-contrast velocity mapping for paravalvular aortic regurgitation (PAR) quantification. All patients undergoing transcatheter aortic valve implantation (TAVI) in our centre between November 2012 and August 2013, without CMR-contraindication were included. PAR severity was assessed 5 days after TAVI using: transthoracic echocardiography (TTE) and CMR [regurgitant volume (RV), regurgitant fraction (RF)]. Aortic regurgitation (AR) index was obtained during TAVI. Thirty of 51 patients who underwent TAVI were included (COREVALVE, n = 10; or EDWARDS SAPIEN XT, n = 20). At TTE, PAR was mild in 22, moderate in 3, and severe in 5 patients. Reliable phase-contrast images were acquired at the sino-tubular junction for SAPIEN and at the tubular portion of the ascending aorta for COREVALVE. The reproducibility of CMR was high (coefficient of correlation = 0.99 for intra- and inter-operator variability). At CMR, RV, and RF were significantly (P < 0.0005) correlated with AR severity at TTE, with mean RF values at 9.2 ± 7.6% in mild, 20.3 ± 4.2% in moderate, and 46.8 ± 10.8% in severe PAR. A cut-off value of RF < 14% at CMR accurately discriminated mild from moderate/severe (sensitivity: 100%, specificity: 82%). The mean AR index was 29.4 ± 6 for mild and 13.8 ± 5 for moderate/severe PAR. Three patients had a RF > 14% and a low AR index <25 despite a mild PAR at TTE, suggesting an underestimation at TTE. CMR is a reproducible, accurate, and reliable method to assess PAR severity. CMR may allow correcting an underestimation at TTE when AR index is doubtful.

Low Incidence of Paravalvular Leakage With the Balloon-Expandable Sapien 3 Transcatheter Heart Valve

We evaluated the clinical and hemodynamic performance of the new balloon-expandable Sapien 3 (Edwards Lifesciences, Irvine, CA) transcatheter heart valve (S3 THV). Between April 2013 and January 2015, 54 consecutive high-risk patients presenting with aortic stenosis were treated with the new S3 THV. Clinical and hemodynamic data as well as device and procedure variables were obtained at baseline, intraoperatively and at 30-days according to Valve Academic Research Consortium-2. The S3 THV was implanted in 41 patients (44% female) via transapical access and in 13 patients via transaortic access. Patients were a mean ± standard deviation age of 80.3 ± 6.0 years. The mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I of all patients was 33.3% ± 13.4%, the mean The Society of Thoracic Surgeons Score was 6.7% ± 5.3%, and the mean EuroSCORE II was 7.0% ± 5.5%. All patients underwent successful implantation (23 mm, n = 12; 26 mm, n = 22; 29 mm, n = 20), without any intraprocedural complications or repeat ballooning. At 30 days, 53 patients (97.8%) showed no or mild paravalvular aortic regurgitation, 1 patient (2.2%) showed moderate regurgitation, and no patients had more than moderate postprocedural aortic regurgitation. Stroke incidence was 3.7% (2 of 54), and all-cause mortality was 3.7% (2 of 54, sepsis and multiorgan failure). Two patients required a new pacemaker. At 30 days, all patients were in New York Heart Association Functional Class I or II, and the mean pressure gradients were 10.8 ± 3.6 mm Hg. The present study shows excellent clinical and hemodynamic outcomes of high-risk transapical valve replacement patients treated with the new S3 THV. The S3 THV shows a low incidence of postoperative aortic regurgitation, with 98% presenting with less than mild aortic regurgitation.

Assessment of Paravalvular Aortic Regurgitation after Transcatheter Aortic Valve Replacement: Intra–Core Laboratory Variability

There is significant disparity in the reported incidence of moderate and severe paravalvular aortic regurgitation (PAR) between the Placement of Aortic Transcatheter Valves (PARTNER) I and PARTNER II trials, which may be related to the echocardiographic methodologies used by separate core laboratories. To further explore the variability in echocardiographic interpretation of PAR, agreement between the grading of PAR by the core laboratory of PARTNER IIB was compared with that by a consortium of echocardiography core laboratory directors. The PARTNER IIB core laboratory reevaluated patients using primarily the circumferential extent of the regurgitant jet for PAR. A consortium of echocardiography core laboratory directors was formed to evaluate the echocardiographic images and to grade PAR and central and total aortic regurgitation in a randomly chosen subset of the randomized patients in the PARTNER IIB trial using a multiwindow, multiparametric approach. Both a four-class scale (none or trace, mild, moderate, and severe) and a seven-class (none, trace, mild, mild to moderate, moderate, moderate to severe, and severe) scale were used. Levels of grading agreement between the consortium and original core laboratory in both scales were determined using weighted κ statistics. Only 87 patients assessed for PAR by the consortium could be paired with readings by the PARTNER IIB core laboratory. Using the four-class grading scheme the weighted κ statistic for PAR was 0.481 (95% confidence limits, 0.367, 0.595). Using the seven-class scale, the weighted κ statistic for PAR was 0.517 (95% confidence limits, 0.431, 0.607). For either grading scheme, 15.9% of patients graded by the PARTNER IIB core laboratory as having moderate PAR would have been graded as having mild PAR using the multiparametric approach. Similar results were seen for central and total aortic regurgitation assessments. Using primarily the circumferential extent criteria, the PARTNER IIB core laboratory overestimated the severity of PAR compared to the consortium using a multi-parametric approach. Although a more granular classification scheme for PAR may slightly improve concordance between core laboratories, differences in the incidence of moderate or severe PAR are likely related to differences in grading methodology. A multiparametric approach is advocated, and other echocardiographic methods for assessing PAR deserve further study.

The Odyssey of TAVR from concept to clinical reality.

On 16 April 2002, my colleagues and I performed, in an inoperable and desperately ill man with critical calcific aortic stenosis (AS), the first clinical percutaneous implantation of an aortic valve bioprosthesis. As of 2013, more than 80,000 patients have been treated; and transcatheter aortic valve replacement (TAVR), so strongly criticized by all the experts throughout the early years, continues to grow in parallel with its constant technological improvements. Transcatheter aortic valve replacement can now be recognized as a medical breakthrough. It is a revolutionary technology that meets an unfulfilled clinical need for a common disease, is validated by rigorous evidence-based studies, and is applicable worldwide. We report here the main phases of this 20-year odyssey and briefly consider the prospects of TAVR, which remains in continuous development.

Preparatory Balloon Aortic Valvuloplasty During Transcatheter Aortic Valve Implantation for Improved Valve Sizing

This study sought to evaluate whether supra-aortic angiography during preparatory balloon aortic valvuloplasty (BAV) improves valve sizing. Current recommendations for valve size selection are based on annular measurements by transesophageal echocardiography and computed tomography, but paravalvular aortic regurgitation (PAR) is a frequent problem. Data of 270 consecutive patients with either conventional sizing (group 1, n = 167) or balloon aortic valvuloplasty-based sizing (group 2, n = 103) were compared. PAR was graded angiographically and quantitatively using several hemodynamic indices. PAR was observed in 113 patients of group 1 and 41 patients of group 2 (67.7% vs. 39.8%, p < 0.001). More than mild PAR was found in 24 (14.4%) patients of group 1 and 8 (7.8%) patients of group 2. According to pre-interventional imaging, 40 (39%) patients had a borderline annulus size, raising uncertainty regarding valve size selection. Balloon sizing resulted in selection of the bigger prosthesis in 30 (29%) and the smaller prosthesis in the remaining patients, and only 1 of these 40 patients had more than mild PAR. As predicted by the hemodynamic indices of PAR, mortality at 30 days and 1 year was less in group 2 than in group 1 (5.8% vs. 9%, p = 0.2 and 10.6% vs. 20%, p = 0.01). Preparatory balloon aortic valvuloplasty during transcatheter aortic valve implantation improves valve size selection, reduces the associated PAR, and increases survival in borderline cases.

Transcatheter aortic valve replacement: many roads lead to Rome...but the implantation technique makes the difference!

Transcatheter aortic valve replacement (TAVR) has emerged as an alternative treatment strategy to surgical aortic valve replacement (SAVR) in high-risk patients and is superior to conservative management. In the currently treated patient population, which is characterised by severe comorbidities, the overall prognosis is significantly influenced by periprocedural complications such as more than mild paravalvular aortic regurgitation (AR) 1,2 . Today, with almost 100,000 implanted prostheses worldwide of the commercially available transcatheter heart valve (THV) systems, we have learned a lot about outcomes and complications after TAVR. However, so-called “next generation” THVs are eagerly awaited to further improve our results by device modifications such as paravalvular space-fillers as well as additional innovations; i.e., recapturability and repositionability. Nonetheless, we should bear in mind that – independent from the use of current and future THVs – the result of TAVR is only as good as the implantation itself and that only the perfectly implanted valve will lead to a good result for the patient. The first challenge before each TAVR procedure is the appropriate sizing of the dimensions of the aortic annulus. This cannot be measured during the procedure by direct visualisation as we can do in patients undergoing SAVR, so we must choose not only the size but also the THV type (selfexpanding vs. balloon expandable) that fits the given anatomy best 3

Challenges in transcatheter valve treatment: aortic regurgitation after transcatheter aortic valve implantation

Paravalvular aortic regurgitation (AR) has a negative impact on the prognosis following transcatheter aortic valve implantation (TAVI). As transcatheter heart valves (THV) are implanted in a sutureless fashion using oversizing to anchor the prosthesis stent frame at the level of the virtual aortic annulus, incomplete stent frame expansion due to heavily calcified cusps, suboptimal placement of the prosthesis, and/or annulus-prosthesis size mismatch due to malsizing can contribute to paravalvular AR with increased mortality in patients with more than mild paravalvular AR. Echocardiography is essential to differentiate between transvalvular and paravalvular AR and to elucidate further the aetiology of AR during the procedure. However, since echocardiographic quantification of AR in TAVI patients remains challenging especially in the implantation situation, a multimodal approach for the evaluation of AR with use of haemodynamic measurements and imaging modalities is imperative to quantify the severity of AR precisely immediately after valve implantation. Thus, patients who will benefit from corrective measures such as post-dilation or valve-in-valve implantation can be identified. In these patients, every measure has to be taken to reduce paravalvular aortic regurgitation in order to improve outcome.

Análise da incidência e preditores clínicos e ecocardiográficos do refluxo paraprotético aórtico após o implante de prótese aórtica transcateter

BACKGROUND: The incidence of paravalvular aortic regurgitation (PAR) seems higher among patients submitted to transcatheter aortic valve implantation and its potential association with an increased late mortality has raised concerns in the scientific community. Our objective was to evaluate the incidence and clinical impact of PAR and establish PAR predictors in our patient population. METHODS: Between July/2009 and February/2013, 112 patients were submitted to transcatheter aortic valve implantation. The degree of PAR after the procedure was assessed according to the VARC 2 criteria. The population was divided into no/mild PAR group and moderate/severe PAR group. RESULTS: Mean age was 82.5 ± 3.9 years, 58.9% were female and the logistic EuroSCORE was 23.6 ± 13.4. There was a decrease in the mean systolic gradient (54.7 ± 15.3 mmHg vs 11.7 ± 4 mmHg; P < 0.01) and a gain in the aortic valve area (0.66 ± 0.15 cm2 vs 1.8 ± 0.3 cm2; P < 0.01). At the end of the procedure 46.4% did not have PAR, and mild or moderate PAR was observed in 42% and 11.6% of the patients. No patient presented severe PAR. Multivariate analysis identified male gender [odds ratio (OR) 5.85, confidence interval (CI] 1.29-26.7; P = 0.022), previous percutaneous aortic val­vuloplasty (OR 18.44, CI 2.30-147.85; P = 0.006), ejection fraction < 35% (OR 4.160, CI 1.014-17.064; P = 0.048) and the presence of severe pulmonary hypertension (OR 7.649, CI 1.86-31.51; P = 0.005) as independent predictors of moderate/severe PAR. CONCLUSIONS: The incidence of moderate/severe PAR was low and comparable to other studies. Male gender, history of prior percutaneous aortic valvuloplasty, presence of severe pulmonary hypertension and severe left ventricular dysfunction were independent predictors of this complication.