CT-derived simulations to predict outcomes in patients undergoing transcatheter aortic valve implantation with an ACURATE Neo2 valve the PRECISE-TAVI cohort B trial.

BACKGROUND: Paravalvular leakage (PVL) and conduction disorders that require permanent pacemaker implantation (PPI) remain clinically relevant challenges after transcatheter aortic valve implantation (TAVI). Computed tomography-based simulations may predict the risk of significant PVL and PPI. AIMS: To evaluate the feasibility and accuracy of preprocedural computer simulation with FEops HEARTguide™ to predict >trace PVL and PPI after TAVI with the self-expanding supra-annular ACURATE Neo2 transcatheter heart valve. METHODS: Prospective multicenter observational study that included consecutive patients undergoing TAVI with an ACURATE Neo2 valve. Computer simulations were performed before the TAVI procedure as part of the preprocedural planning. Follow-up period for PPI and PVL was 30 days. RESULTS: Sixty-five patients were included (median age 81 years (25th-75th percentile 77-84.5)). New left bundle branch block occurred in five patients (7.7%) and PPI in two patients (3%). Contact pressure index (CPI) was similar for patients with vs without new conduction disorders. Patients with PPI had numerically higher CPI than those without PPI (median CPI 20.0% (25th-75th percentile 15.0-25.0) vs. 13.0% (25th-75th percentile 5.5-18), p = 0.27). More than trace PVL occurred in 30%. Median PVL was significantly lower in patients with none-trace PVL (3.2 mL/s [25th-75th percentile 2.2-5.0]), compared to mild PVL (5.2 mL/s [25th-75th percentile 3.2-10.3]) and moderate PVL (12.6 mL/s [25th-75th percentile 3.9-21.3])(p = 0.036). A simulated PVL-cutoff of 9.65 mL/s identified patients with >trace PVL (AUC 0.70 (95% CI 0.55-0.85), sensitivity 42%, specificity 95%). CONCLUSION: In our study FEops HEARTguide™ simulations identified patients at risk for >trace PVL with ACURATE Neo2 TAVI but not for PPI.

Demographics and outcomes of patients younger than 75 years undergoing aortic valve interventions in Rotterdam.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is considered a safe and effective alternative to surgical aortic valve replacement (SAVR) for elderly patients across the operative risk spectrum. In the Netherlands, TAVI is reimbursed only for patients with a high operative risk. Despite this, one fifth of TAVI patients are < 75 years of age. We aim to compare patient characteristics and outcomes of TAVI and SAVR patients < 75 years. METHODS: This study included all patients < 75 years without active endocarditis undergoing TAVI or SAVR for severe aortic stenosis, mixed aortic valve disease or degenerated aortic bioprosthesis between 2015 and 2020 at the Erasmus University Medical Centre. Dutch authority guidelines were used to classify operative risk. RESULTS: TAVI was performed in 292 patients, SAVR in 386 patients. Based on the Dutch risk algorithm, 59.6% of TAVI patients and 19.4% of SAVR patients were at high operative risk. There was no difference in 30-day all-cause mortality between TAVI and SAVR (2.4% vs 0.8%, p = 0.083). One-year and 5­year mortality was higher after TAVI than after SAVR (1-year: 12.5% vs 4.3%, p < 0.001; 5­year: 36.8% vs 12.0%, p < 0.001). Within risk categories we found no difference between treatment strategies. Independent predictors of mortality were cardiovascular comorbidities (left ventricular ejection fraction < 30%, atrial fibrillation, pulmonary hypertension) and the presence of malignancies, liver cirrhosis or immunomodulatory drug use. CONCLUSION: At the Erasmus University Medical Centre, in patients < 75 years, TAVI is selected for higher-risk phenotypes and overall has higher long-term mortality than SAVR. We found no evidence for worse outcome within risk categories.

Diagnostic Value of Aortic Valve Calcification Levels in the Assessment of Low-Gradient Aortic Stenosis.

BACKGROUND: In patients with low-gradient aortic stenosis (AS) and low transvalvular flow, dobutamine stress echocardiography (DSE) is recommended to determine AS severity, whereas the degree of aortic valve calcification (AVC) supposedly correlates with AS severity according to current European and American guidelines. OBJECTIVES: The purpose of this study was to assess the relationship between AVC and AS severity as determined using echocardiography and DSE in patients with aortic valve area <1 cm2 and peak aortic valve velocity <4.0 m/s. METHODS: All patients underwent DSE to determine AS severity and multislice computed tomography to quantify AVC. Receiver-operating characteristics curve analysis was used to assess the diagnostic value of AVC for AS severity grading as determined using echocardiography and DSE in men and women. RESULTS: A total of 214 patients were included. Median age was 78 years (25th-75th percentile: 71-84 years) and 25% were women. Left ventricular ejection fraction was reduced (<50%) in 197 (92.1%) patients. Severe AS was diagnosed in 106 patients (49.5%). Moderate AS was diagnosed in 108 patients (50.5%; in 77 based on resting transthoracic echocardiography, in 31 confirmed using DSE). AVC score was high (≥2,000 for men or ≥1,200 for women) in 47 (44.3%) patients with severe AS and in 47 (43.5%) patients with moderate AS. AVC sensitivity was 44.3%, specificity was 56.5%, and positive and negative predictive values for severe AS were 50.0% and 50.8%, respectively. Area under the receiver-operating characteristics curve was 0.508 for men and 0.524 for women. CONCLUSIONS: Multi-slice computed tomography-derived AVC scores showed poor discrimination between grades of AS severity using DSE and cannot replace DSE in the diagnostic work-up of low-gradient severe AS.

Clinical value of CT-derived simulations of transcatheter-aortic-valve-implantation in challenging anatomies the PRECISE-TAVI trial.

BACKGROUND: Preprocedural computed tomography planning improves procedural safety and efficacy of transcatheter aortic valve implantation (TAVI). However, contemporary imaging modalities do not account for device-host interactions. AIMS: This study evaluates the value of preprocedural computer simulation with FEops HEARTguideTM on overall device success in patients with challenging anatomies undergoing TAVI with a contemporary self-expanding supra-annular transcatheter heart valve. METHODS: This prospective multicenter observational study included patients with a challenging anatomy defined as bicuspid aortic valve, small annulus or severely calcified aortic valve. We compared the heart team's transcatheter heart valve (THV) planning decision based on (1) conventional multislice computed tomography (MSCT) and (2) MSCT imaging with FEops HEARTguideTM simulations. Clinical outcomes and THV performance were followed up to 30 days. RESULTS: A total of 77 patients were included (median age 79.9 years (IQR 74.2-83.8), 42% male). In 35% of the patients, preprocedural planning changed after FEops HEARTguideTM simulations (change in valve size selection [12%] or target implantation height [23%]). A new permanent pacemaker implantation (PPI) was implanted in 13% and >trace paravalvular leakage (PVL) occurred in 28.5%. The contact pressure index (i.e., simulation output indicating the risk of conduction abnormalities) was significantly higher in patients with a new PPI, compared to those without (16.0% [25th-75th percentile 12.0-21.0] vs. 3.5% [25th-75th percentile 0-11.3], p < 0.01) The predicted PVL was 5.7 mL/s (25th-75th percentile 1.3-11.1) in patients with none-trace PVL, 12.7 (25th-75th percentile 5.5-19.1) in mild PVL and 17.7 (25th-75th percentile 3.6-19.4) in moderate PVL (p = 0.04). CONCLUSION: FEops HEARTguideTM simulations may provide enhanced insights in the risk for PVL or PPI after TAVI with a self-expanding supra-annular THV in complex anatomies.

Changing haemodynamic status of patients referred for transcatheter aortic valve intervention during the COVID-19 pandemic.

INTRODUCTION: Delays in the diagnosis and referral of aortic stenosis (AS) during the coronavirus disease 2019 (COVID-19) pandemic may have affected the haemodynamic status of AS patients. We aimed to compare clinical and haemodynamic characteristics of severe AS patients referred for transcatheter aortic valve implantation (TAVI) or balloon aortic valvuloplasty (BAV) before the pandemic versus two subsequent periods. METHODS: This study compared three 1­year historical cohorts: a pre-COVID-19 group (PCOV), a 1st-year COVID-19 group (COV-Y1) and a 2nd-year COVID-19 group (COV-Y2). The main parameters were baseline New York Heart Association (NYHA) functional class, left ventricular ejection fraction (LVEF) and left ventricular end-diastolic pressure (LVEDP). Demographics, procedural characteristics and 30-day clinical outcomes were assessed. The transition time between heart team decision and TAVI was examined. Pairwise group comparisons were performed (PCOV vs COV-1Y and COV-1Y vs COV-2Y). RESULTS: A total of 720 patients were included with 266, 249 and 205 patients in the PCOV, COV-Y1 and COV-Y2 groups, respectively. BAV was performed in 28 patients (4%). NYHA class did not differ across the cohorts. Compared to PCOV, LVEF was slightly lower in COV-Y1 (58% (49-60%) vs 57% (45-60%), p = 0.03); no difference was observed when comparing COV-Y1 and COV-Y2. LVEDP was higher in COV-Y1 than in PCOV (20 mm Hg (16-26 mm Hg) vs 17 mm Hg (13-24 mm Hg), p = 0.01). No difference was found when comparing LVEDP between COV-Y1 and COV-Y2. Thirty-day mortality did not differ between groups. Transition time was reduced in the COVID era. Duration of hospital stay declined over the study period. CONCLUSIONS: Patients undergoing TAVI during the COVID-19 pandemic had more advanced AS illustrated by lower LVEF and higher LVEDP, but there were no differences in clinical outcome. The TAVI pathway became more efficient.

Validation of a Three-Dimensional Computed Tomography Reconstruction Tool for Aortic Valve Calcium Quantification.

Background: Aortic valve calcification correlates with the severity of aortic valve stenosis and a high calcium score is associated with conduction disturbances and paravalvular leakage after transcatheter aortic valve replacement. The 3mensio Structural Heart is a semiautomated software package to facilitate aortic root analysis by multislice computed tomography.The aim of the contemporary study is to validate a semiautomated calcium quantification scoring tool with a conventional manual calcium quantification tool. Methods: Fifty randomly selected patients who underwent multislice computed tomography for preprocedural planning were retrospectively selected to compare the semiautomated aortic valve Agatston calcium score by 3mensio with the manually obtained score using IntelliSpace Portal as standard reference. Results: Patients had a mean age of 76.7 ± 7.4 years and 60% were male. The median Agatston score was 3390 [interquartile range 1877-4509] with 3mensio and 3434 [interquartile range 1839-4620] with IntelliSpace.The mean difference was -0.18 [95% confidence interval (CI) -53.8 to 53.4]. The intraclass correlation coefficient between the Agatston scores using IntelliSpace and 3mensio showed an excellent correlation of 0.995 [95% CI 0.992-0.997], p ≤ 0.001. The interobserver and intraobserver variability was 0.993 ([95% CI 0.961-0.998], p ≤ 0.001) and 0.995([95%CI 0.981-0.999], p = <0.001), respectively. Conclusions: The semiautomated calcium quantification module in 3mensio Structural Heart highly correlated with a conventional manual calcium scoring tool.

Sex-Specific Differences in Aortic Valve Calcification Between Bicuspid and Tricuspid Severe Aortic Stenosis.

Sex-specific thresholds of aortic valve calcification (AVC) correlate with aortic stenosis (AS) and may complement echocardiography to determine AS severity. Importantly, current guideline-recommended thresholds of AVC scores derived by multislice computed tomography do not distinguish between bicuspid and tricuspid aortic valves. The objective of this study was to evaluate the sex-specific differences in the amount of AVC in patients with severe AS and tricuspid (TAV) versus bicuspid (BAV) aortic valve morphologies, retrospectively evaluated by 2 tertiary care institutions. The inclusion criteria comprised patients with severe AS and a left ventricular ejection fraction ≥50% and suitable imaging examinations. The study included 1,450 patients (723 men; 49.9%) with severe AS, including 1,335 patients with TAV (92.1%) and 115 with BAV (17.9%). The calculated Agatston score was higher in BAV patients (men: BAV 4,358 [2,644 to 6,005] AU vs TAV 2,643 [1,727 to 3,794] AU, p <0.01; women: BAV 2,174 [1,330 to 4,378] AU vs TAV 1,703 [964 to 2,534] AU, p <0.01), also when indexed for valve dimensions and body surface area (men: BAV 2,227 [321 to 3,105] AU/m2 vs TAV 1,333 [872 to 1,913] AU/m2, p <0.01; women: BAV 1,326 [782 to 2,148] AU/m2 vs TAV 930 [546 to 1,456] AU/m2, p <0.01). Differences between the BAV- and TAV-derived Agatston score was more prominent in concordant severe AS. In conclusion, sex-specific Agatston scores in severe AS were approximately 1/3 higher in patients with BAV than in patients with TAV for both women and men. Optimal AVC thresholds should be adjusted for BAV, also respecting considerable prognostic implications.

Explant vs Redo-TAVR After Transcatheter Valve Failure: Mid-Term Outcomes From the EXPLANTORREDO-TAVR International Registry.

BACKGROUND: Valve reintervention after transcatheter aortic valve replacement (TAVR) failure has not been studied in detail. OBJECTIVES: The authors sought to determine outcomes of TAVR surgical explantation (TAVR-explant) vs redo-TAVR because they are largely unknown. METHODS: From May 2009 to February 2022, 396 patients in the international EXPLANTORREDO-TAVR registry underwent TAVR-explant (181, 46.4%) or redo-TAVR (215, 54.3%) for transcatheter heart valve (THV) failure during a separate admission from the initial TAVR. Outcomes were reported at 30 days and 1 year. RESULTS: The incidence of reintervention after THV failure was 0.59% with increasing volume during the study period. Median time from index-TAVR to reintervention was shorter in TAVR-explant vs redo-TAVR (17.6 months [IQR: 5.0-40.7 months] vs 45.7 months [IQR: 10.6-75.6 months]; P < 0.001], respectively. TAVR-explant had more prosthesis-patient mismatch (17.1% vs 0.5%; P < 0.001) as the indication for reintervention, whereas redo-TAVR had more structural valve degeneration (63.7% vs 51.9%; P = 0.023), with a similar incidence of ≥moderate paravalvular leak between groups (28.7% vs 32.8% in redo-TAVR; P = 0.44). There was a similar proportion of balloon-expandable THV failures (39.8% TAVR-explant vs 40.5% redo-TAVR; P = 0.92). Median follow-up was 11.3 (IQR: 1.6-27.1 months) after reintervention. Compared with redo-TAVR, TAVR-explant had higher mortality at 30 days (13.6% vs 3.4%; P < 0.001) and 1 year (32.4% vs 15.4%; P = 0.001), with similar stroke rates between groups. On landmark analysis, mortality was similar between groups after 30 days (P = 0.91). CONCLUSIONS: In this first report of the EXPLANTORREDO-TAVR global registry, TAVR-explant had a shorter median time to reintervention, with less structural valve degeneration, more prosthesis-patient mismatch, and similar paravalvular leak rates compared with redo-TAVR. TAVR-explant had higher mortality at 30 days and 1 year, but similar rates on landmark analysis after 30 days.

Implantation of contemporary transcatheter aortic valves in small aortic annuli: the international multicentre TAVI-SMALL 2 registry.

BACKGROUND: Treatment of aortic stenosis in patients with small annuli is challenging and can result in prosthesis-patient mismatch (PPM). AIMS: We aimed to compare the forward flow haemodynamics and clinical outcomes of contemporary transcatheter valves in patients with small annuli. METHODS: The TAVI-SMALL 2 international retrospective registry included 1,378 patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm2) treated with transfemoral self-expanding (SEV; n=1,092) and balloon-expandable valves (BEV; n=286) in 16 high-volume centres between 2011 and 2020. Analyses comparing SEV versus BEV and supra-annular (SAV; n=920) versus intra-annular valves (IAV; n=458) included inverse probability of treatment weighting (IPTW). The primary endpoints were the predischarge mean aortic gradient and incidence of severe PPM. The secondary endpoint was the incidence of more than mild paravalvular leak (PVL). RESULTS: The predischarge mean aortic gradient was lower after SAV versus IAV (7.8±3.9 vs 12.0±5.1; p<0.001) and SEV versus BEV implantation (8.0±4.1 vs 13.6±4.7; p<0.001). Severe PPM was more common with IAV and BEV when compared to SAV and SEV implantation, respectively, (8.8% vs 3.6%; p=0.007 and 8.7% vs 4.6%; p=0.041). At multivariable logistic regression weighted by IPTW, SAV protected from severe PPM regardless of its definition. More than mild PVL occurred more often with SEV versus BEV (11.6% vs 2.6%; p<0.001). CONCLUSIONS: In small aortic annuli, implantation of SAV and SEV was associated with a more favourable forward haemodynamic profile than after IAV and BEV implantation, respectively. More than mild PVL was more common after SEV than BEV implantation.