Right vs. left ventricular longitudinal strain for mortality prediction after transcatheter aortic valve implantation.

Introduction: This study aims at exploring biventricular remodelling and its implications for outcome in a representative patient cohort with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI). Methods and results: Pre-interventional echocardiographic examinations of 100 patients with severe AS undergoing TAVI were assessed by speckle tracking echocardiography of both ventricles. Association with mortality was determined for right ventricular global longitudinal strain (RVGLS), RV free wall strain (RVFWS) and left ventricular global longitudinal strain (LVGLS). During a median follow-up of 1,367 [959-2,123] days, 33 patients (33%) died. RVGLS was lower in non-survivors [-13.9% (-16.4 to -12.9)] than survivors [-17.1% (-20.2 to -15.2); P = 0.001]. In contrast, LVGLS as well as the conventional parameters LV ejection fraction (LVEF) and RV fractional area change (RVFAC) did not differ (P = ns). Kaplan-Meier analyses indicated a reduced survival probability when RVGLS was below the -14.6% cutpoint (P < 0.001). Lower RVGLS was associated with higher mortality [HR 1.13 (95% CI 1.04-1.23); P = 0.003] independent of LVGLS, LVEF, RVFAC, and EuroSCORE II. Addition of RVGLS clearly improved the fitness of bivariable and multivariable models including LVGLS, LVEF, RVFAC, and EuroSCORE II with potential incremental value for mortality prediction. In contrast, LVGLS, LVEF, and RVFAC were not associated with mortality. Discussion: In patients with severe AS undergoing TAVI, RVGLS but not LVGLS was reduced in non-survivors compared to survivors, differentiated non-survivors from survivors, was independently associated with mortality, and exhibited potential incremental value for outcome prediction. RVGLS appears to be more suitable than LVGLS for risk stratification in AS and timely valve replacement.

Cardiac Virtual Noncontrast Images for Calcium Quantification with Photon-counting Detector CT.

Purpose: To assess the accuracy of aortic valve calcium (AVC), mitral annular calcium (MAC), and coronary artery calcium (CAC) quantification and risk stratification using virtual noncontrast (VNC) images from late enhancement photon-counting detector CT as compared with true noncontrast images. Materials and Methods: This retrospective, institutional review board-approved study evaluated patients undergoing photon-counting detector CT between January and September 2022. VNC images were reconstructed from late enhancement cardiac scans at 60, 70, 80, and 90 keV using quantum iterative reconstruction (QIR) strengths of 2-4. AVC, MAC, and CAC were quantified on VNC images and compared with quantification of AVC, MAC, and CAC on true noncontrast images using Bland-Altman analyses, regression models, intraclass correlation coefficients (ICC), and Wilcoxon tests. Agreement between severe aortic stenosis likelihood categories and CAC risk categories determined from VNC and true noncontrast images was assessed by weighted κ analysis. Results: Ninety patients were included (mean age, 80 years ± 8 [SD]; 49 male patients). Scores were similar on true noncontrast images and VNC images at 80 keV for AVC and MAC, regardless of QIR strengths, and VNC images at 70 keV with QIR 4 for CAC (all P > .05). The best results were achieved using VNC images at 80 keV with QIR 4 for AVC (mean difference, 3; ICC = 0.992; r = 0.98) and MAC (mean difference, 6; ICC = 0.998; r = 0.99), and VNC images at 70 keV with QIR 4 for CAC (mean difference, 28; ICC = 0.996; r = 0.99). Agreement between calcification categories was excellent on VNC images at 80 keV for AVC (κ = 0.974) and on VNC images at 70 keV for CAC (κ = 0.967). Conclusion: VNC images from cardiac photon-counting detector CT enables patient risk stratification and accurate quantification of AVC, MAC, and CAC.Keywords: Coronary Arteries, Aortic Valve, Mitral Valve, Aortic Stenosis, Calcifications, Photon-counting Detector CT Supplemental material is available for this article © RSNA, 2023.

Incremental Prognostic Value of Coronary Artery Calcium Score for Predicting All-Cause Mortality after Transcatheter Aortic Valve Replacement.

Background Current risk models show limited performances for predicting all-cause mortality after transcatheter aortic valve replacement (TAVR). Purpose To determine the prognostic value of coronary artery calcium (CAC) scoring for predicting 30-day and 1-year mortality in patients undergoing TAVR. Materials and Methods In this single-center institutional review board-approved secondary analysis of prospectively collected data (SwissTAVI Registry), the authors evaluated participants who, before TAVR, underwent CT that included a nonenhanced electrocardiography-gated cardiac scan between May 2008 and September 2019 and who had not undergone previous coronary revascularization. Clinical data, including the European System for Cardiac Operative Risk Evaluation (EuroSCORE II), were recorded. The CAC score was determined, and 30-day and 1-year all-cause mortality were assessed by using Cox regression analyses. Results In total, 309 participants (mean age ± standard deviation, 81 years ± 7; 175 women) were included, with a median CAC score of 334 (interquartile range, 104-987). Seventy-seven of the 309 participants (25%) had a CAC score greater than or equal to 1000. A CAC score of 1000 or greater served as an independent predictor of 30-day (hazard ratio [HR], 4.5 [95% CI: 1.5, 13.6] compared with a CAC score <1000; P = .007) and 1-year (HR, 4.3 [95% CI: 1.5, 12.7] compared with a CAC score of 0-99; P = .008) mortality after TAVR. Similar trends were observed for each point increase of the EuroSCORE II as an independent predictor of 30-day (HR, 1.22 [95% CI: 1.10, 1.36]; P < .001) and 1-year (HR, 1.16 [95% CI: 1.08, 1.25]; P < .001) mortality. Adding the CAC score to the EuroSCORE II provided incremental prognostic value for 1-year mortality after TAVR over the EuroSCORE II alone (concordance index, 0.76 vs 0.69; P = .04). Conclusion In participants without prior coronary revascularization, the coronary artery calcium score represented an independent predictor of 30-day and 1-year mortality after transcatheter aortic valve replacement. ClinicalTrials.gov identifier, NCT01368250 © RSNA, 2021 Online supplemental material is available for this article. See also the editorial by Almeida in this issue.

Aortic valve calcification scoring with computed tomography: impact of iterative reconstruction techniques.

To investigate whether image reconstruction with iterative reconstruction (IR) affects aortic valve calcification (AVC) scoring and likelihood categorization of severe aortic stenosis (AS). In this IRB-approved retrospective study, we included 100 consecutive patients with AS (40 females; mean age 77 ± 10 years; age range: 36-99 years) undergoing CT prior to transcatheter aortic valve replacement. Non-enhanced, electrocardiography-gated CT of the heart was reconstructed with filtered back projection (FBP) and with advanced modeled IR at strength levels 1-5. AVC Agatston scores were calculated and gender-specific cut-off values for AS likelihood categorization were applied according to current European Society of Cardiology recommendations (from unlikely to very likely). Friedman test with post-hoc Bonferroni correction was applied to analyze interval- and ordinal-scaled data. Compared to FBP, each IR strength level produced significantly different AVC Agatston scores (p < 0.001-0.002). Median AVC Agatston score for image reconstruction with FBP was 2527 (IQR: 1711-3663) and decreased with increasing IR strength levels up to 2281 (IQR: 1471-3357) at strength level 5. Likelihood categorization of severe AS was significantly different among image reconstruction algorithms (p < 0.001). Image reconstruction with IR strength level 5 led to a downward shift of likelihood categorization in 28 patients (28%) compared to images reconstructed with FBP. IR significantly impacts AVC scoring with significantly decreasing AVC scores with increasing IR strength levels. This leads to relevant changes in likelihood categorization of patients with severe AS., leading to underestimation of severe AS.

Valor pronóstico diferencial de la galectina-3 según los valores de antígeno carbohidrato 125 para el implante percutáneo de válvula aórtica / Differential prognostic value of galectin-3 according to carbohydrate Aatigen 125 levels in transcatheter aortic valve implantation

Introducción y objetivos: La galectina-3 (Gal-3) y el antígeno carbohidrato 125 (CA125) han mostrado relación con eventos adversos tras el implante percutáneo de válvula aórtica (TAVI). Datos experimentales indican que podrían tener cierta interacción molecular. El objetivo del presente estudio es establecer la asociación de Gal-3 y CA125 con el pronóstico tras el TAVI. Métodos: Se incluyó en total a 439 pacientes. El objetivo primario fue el compuesto de mortalidad por todas las causas o reingreso por insuficiencia cardiaca tras el TAVI. Resultados: El objetivo primario se produjo en el 16,4% de la muestra. Los valores de Gal-3 se dicotomizaron en elevados (≥ 8,71 ng/ml) y no elevados. Los pacientes con Gal-3 elevado (31,9%) presentaron mayor riego de sufrir el objetivo primario (el 25 frente al 12,4%; HR=2,26; p<0,001). Tras el ajuste multivariable, la asociación entre Gal-3 y el pronóstico se situó en el límite de la significación (HR=1,59; p=0,068). En consecuencia, el CA125 se dicotomizó en ≥ 18,4 U/ml. El CA125 estaba elevado en el 51,9% y también se asoció con mayor riesgo del objetivo primario (el 25,4 frente al 6,6%; HR=4,20; p<0,001). Tras el ajuste multivariable, los valores de CA125 elevados (HR=2,83; p=0,001) mantenían la asociación independiente con el riesgo del objetivo primario. Se observó un efecto pronóstico diferencial para Gal-3 según los valores de CA125 (p de interacción=0,048). Así, los valores de Gal-3 elevados se asociaron significativamente con el pronóstico de los pacientes con CA125 elevado (el 38,8 frente al 18,2%; HR=2,02; p=0,015). Por el contrario, el Gal-3 no aportó información pronóstica con valores de CA125 bajos (el 6,6 frente al 6,7%; HR=1,16; p=0,981). Conclusiones: En pacientes sometidos a TAVI, los valores de Gal-3 se asociaron con mayor riesgo de eventos adversos clínicos solamente en presencia de valores de CA125 elevados

Introduction and objectives: Galectin-3 (Gal-3) and carbohydrate antigen 125 (CA125) have been associated with adverse outcomes after transcatheter aortic valve implantation (TAVI). Experimental data have suggested a potential molecular interaction. Therefore, we assessed the association of Gal-3 and CA125 with prognosis after TAVI. Methods: A total of 439 patients were enrolled. The primary endpoint was a composite of all-cause mortality or readmission for worsening heart failure after TAVI. Results: The primary endpoint occurred in 16.4%. Gal-3 was dichotomized at ≥ 8.71 ng/mL into elevated and not elevated. Gal-3 was elevated in 31.9% and was associated with a higher risk of the primary endpoint (25% vs 12.4%, HR, 2.26; P<.001). After multivariable adjustment, the association of elevated Gal-3 with the primary endpoint was borderline significant (HR, 1.59; P=.068). CA125 was dichotomized at ≥ 18.4 U/mL, accordingly. CA125 was elevated in 51.9% and was also associated with a higher risk of the primary endpoint (25.4% vs 6.6%, HR, 4.20; P<.001). After multivariable adjustment, elevated CA125 (HR, 2.83; P=.001) remained independently associated with the primary endpoint. A differential prognostic effect of Gal-3 was found across CA125 status (P for interaction=.048). Elevated Gal-3 was associated with a higher risk of the primary endpoint when CA125 was elevated (38.8% vs 18.2%, HR, 2.02; P=.015) but lacked significance when CA125 was not elevated (6.6% vs 6.7%, HR, 1.16; P=.981). Conclusions: In patients undergoing TAVI, Gal-3 predicted adverse clinical outcomes only when CA125 was elevated

Prevalence and Clinical Impact of Iron Deficiency in Patients With Severe Aortic Stenosis Referred for Transcatheter Aortic Valve Implantation.

Patients referred for transcatheter aortic valve implantation (TAVI) are typically elderly with several co-morbidities, which might limit prognosis despite successful procedural outcome. To date, the prevalence and clinical impact of iron deficiency (ID) in patients with severe aortic stenosis who underwent TAVI remains poorly defined. This study included 495 patients who underwent transfemoral TAVI for severe symptomatic aortic stenosis. ID was defined as ferritin <100 ng/ml or ferritin 100 to 300 ng/ml, when transferrin saturation was <20%. The primary end point of the study was a composite of all-cause mortality, unplanned readmission for worsening heart failure or red blood cell transfusions during the first year after TAVI, which occurred in 22% (109 of 495) of the population. ID was present in 54% (268 of 495) of the entire cohort and was associated with a higher rate of the primary end point (27.6% [74 of 268] vs 15.4% [35 of 227]; p = 0.001). After multivariable adjustment, the association of ID with the primary end point remained significant (hazard ratio 1.64, 95% confidence interval [1.08 to 2.48]; p = 0.019). In a subgroup of ferropenic patients (n = 56), treatment with intravenous iron before TAVI was feasible, resulting in a considerable improvement of ferritin, transferrin saturation and symptoms at 30-day follow-up. In conclusion, ID is common in TAVI patients and is associated with adverse clinical outcome after TAVI. Correction of ID with intravenous iron seems feasible in contemporary TAVI patients. Whether this reduces transfusion rates and impacts clinical outcome after TAVI remains to be investigated in future prospective trials.

Evaluación multicéntrica del sobredimensionamiento de la prótesis transcatéter SAPIEN 3. Impacto en el fallo del dispositivo y nuevos implantes de marcapasos / Multicenter evaluation of prosthesis oversizing of the SAPIEN 3 transcatheter heart valve. Impact on device failure and new pacemaker implantations

Introducción y objetivos: Para lograr el éxito del dispositivo, se recomienda cierto sobredimensionamiento de la prótesis (SP) SAPIEN 3. Sin embargo, un aumento en el SP puede incrementar las tasas de implante de marcapasos definitivo (IMD). Por lo tanto, se investiga la influencia del SP en el fallo del dispositivo y el IMD. Métodos: Se trató con SAPIEN 3 a 804 pacientes en 3 centros. El SP, determinado mediante tomografía computarizada multicorte, se calculó y analizó como variable continua y categorizada en incrementos del 5%, con -4% a 0 como referencia. Resultados: Se produjo fallo del dispositivo en el 8,8% de los pacientes. La mediana de SP fue menor en los pacientes con fallo del dispositivo que en aquellos con éxito (el +4 frente al +8%; p=0,038). El SP mostró un patrón de riesgo no lineal, con una tasa de fallo del dispositivo significativamente reducida para valores entre el +4 y el +22%. No hubo ningún caso de fuga paravalvular II+ entre un +10 y un +20% de SP. La tasa general de IMD fue del 16,2% y la mediana de SP fue significativamente mayor en los pacientes con IMD (IMD, el +9% frente a no IMD, el +7%; p=0,025), mientras que la profundidad del implante no varió entre pacientes con y sin IMD (6,9+/-1,7 frente a 6,6+/-1,9mm; p=0,101). El riesgo de IMD aumentó con el aumento del SP y fue mayor en las 2 categorías más altas. Conclusiones: El incremento en el SP reduce el riesgo de fallo del dispositivo, pero aumenta el de IMD. No se halló un intervalo de SP ideal para minimizar los riesgos de fallo del dispositivo e IMD

Introduction and objectives: A certain degree of prosthesis oversizing (OS) is recommended for the SAPIEN 3 to achieve device success. However, an increase in OS may increase permanent pacemaker implantation (PPI) rates. We therefore investigated the influence of OS on device failure and PPI. Methods: A total of 804 patients were treated with SAPIEN 3 at 3 centers. Multislice computed tomography-derived OS was calculated and analyzed both as a continuous variable and categorized in 5% increments with −4% to 0% as reference. Results: Device failure occurred in 8.8% of patients. Median OS was lower in patients with device failure vs those with device success (+4% vs +8%; P=.038). A nonlinear risk pattern was shown for OS with a significantly reduced device failure rate within 4% to +22% of OS. There was no case of paravalvular leakage II+ between +10% to +20% of OS. The overall PPI rate was 16.2% and the median OS was significantly larger in patients with PPI (PPI: +9% vs no PPI: +7%; P = .025), while implantation depth did not vary in patients with vs without PPI (6.9+/-1.7 mm vs 6.6+/-1.9 mm; P=.101). The risk of PPI increased with increasing OS and was highest in the 2 highest categories. Conclusions: An increase in OS reduces the risk for device failure but increases the risk for PPI. There was no ideal range of OS to minimize both device failure and PPI

One-year clinical outcome with a novel self-expanding transcatheter heart valve.

OBJECTIVES: To evaluate 1-year outcome using the ACURATE neo (Symetis S.A., a Boston Scientific Company, Ecublens, Switzerland) according to the updated Valve Academic Research Consortium (VARC-2) with emphasis on the composite endpoints "clinical efficacy after 30 days" and "time-related valve safety". BACKGROUND: Initial reports on the clinical performance of patients treated with the ACURATE neo are promising; however, information regarding one-year outcome is scarce, especially with regard to the composite endpoints proposed by the VARC-2. METHODS: One hundred and fifty one consecutive patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) with the ACURATE neo for severe aortic valve stenosis were enrolled. Data were prospectively collected and event rates during follow-up were calculated as the Kaplan-Meier estimates. RESULTS: Mean age was 81.1 ± 5.9 years and 49.7% (75/151) were female with a median logistic EuroScore of 13.8% [8.2-20.5]. Device success was achieved in 88.1% (133/151) and procedure related mortality was 0.7% (1/151). At one-year, all-cause mortality was 3.3% (5/151), while permanent pacemaker implantation occurred in 12.7% (19/151) of patients. The "clinical efficacy after 30 days" was observed in 24.8% (37/151), where the main contributor was symptom worsening in 14.8% (22/151) of cases. "Time-related valve safety" occurred in 22.0% (33/151) with structural valve deterioration as main contributor in 10.7% (16/151) of cases. CONCLUSIONS: Using the ACURATE neo, we found a favorable safety profile with low all-cause mortality at 1 year. The reported VARC-2 defined composite endpoints at 1 year reveal low rates of "clinical efficacy after 30 days" and "time-related valve safety".

Assessing the level of radiation experienced by anesthesiologists during transfemoral Transcatheter Aortic Valve Implantation and protection by a lead cap.

OBJECTIVE: Transfemoral Transcatheter Aortic Valve Implantation (TAVI) has become a standard therapy for patients with aortic valve stenosis. Fluoroscopic imaging is essential for TAVI with the anesthesiologist's workplace close to patient's head side. While the use of lead-caps has been shown to be useful for interventional cardiologists, data are lacking for anesthesiologists. METHODS: A protective cap with a 0.35 lead-equivalent was worn on 15 working days by one anesthesiologist. Six detectors (three outside, three inside) were analyzed to determine the reduction of radiation. Literature search was conducted between April and October 2018. RESULTS: In the observational period, 32 TAVI procedures were conducted. A maximum radiation dose of 0.55 mSv was detected by the dosimeters at the outside of the cap. The dosimeters inside the cap, in contrast, displayed a constant radiation dose of 0.08 mSv. CONCLUSION: The anesthesiologist's head is exposed to significant radiation during TAVI and it can be protected by wearing a lead-cap.

Multicenter Evaluation of Prosthesis Oversizing of the SAPIEN 3 Transcatheter Heart Valve. Impact on Device Failure and New Pacemaker Implantations.

INTRODUCTION AND OBJECTIVES: A certain degree of prosthesis oversizing (OS) is recommended for the SAPIEN 3 to achieve device success. However, an increase in OS may increase permanent pacemaker implantation (PPI) rates. We therefore investigated the influence of OS on device failure and PPI. METHODS: A total of 804 patients were treated with SAPIEN 3 at 3 centers. Multislice computed tomography-derived OS was calculated and analyzed both as a continuous variable and categorized in 5% increments with -4% to 0% as reference. RESULTS: Device failure occurred in 8.8% of patients. Median OS was lower in patients with device failure vs those with device success (+4% vs +8%; P=.038). A nonlinear risk pattern was shown for OS with a significantly reduced device failure rate within 4% to +22% of OS. There was no case of paravalvular leakage II+ between +10% to +20% of OS. The overall PPI rate was 16.2% and the median OS was significantly larger in patients with PPI (PPI: +9% vs no PPI: +7%; P = .025), while implantation depth did not vary in patients with vs without PPI (6.9±1.7 mm vs 6.6±1.9 mm; P=.101). The risk of PPI increased with increasing OS and was highest in the 2 highest categories. CONCLUSIONS: An increase in OS reduces the risk for device failure but increases the risk for PPI. There was no ideal range of OS to minimize both device failure and PPI.

Prophylactic ECMO during TAVI in patients with depressed left ventricular ejection fraction.

BACKGROUND: This study investigated the impact of prophylactic veno-arterial extracorporeal membrane oxygenation (pECMO) in patients with depressed left ventricular ejection fraction (dLVEF) undergoing transcatheter aortic valve implantation (TAVI). METHODS: Out of 1490 patients undergoing TAVI at two centers (2010-2015), 222 patients had dLVEF (≤ 40%). Of these, 21 patients (10%) underwent TAVI with pECMO. Complications and outcome according to pECMO were analyzed in the entire and in a propensity-matched population. RESULTS: In the entire population, patients with pECMO had a higher logEuroScore I (33% ± 19 vs. 25% ± 17; p = 0.037), worse LVEF (26% ± 7 vs. 32% ± 7; p = 0.001), more major bleedings (29% vs. 9%; p = 0.015), higher transfusion rate (30% vs. 10%; p = 0.019) and longer in-hospital stay (9.0 [7.0;14.0] vs. 7.0 [5.0;10.0] days; p = 0.024). After propensity matching only transfusion rate remained higher with pECMO (30% vs. 7%; p = 0.025). In the entire population, rate and risk of 30-day mortality was higher with pECMO (24% vs. 6%, HR 95%CI 4.29 [1.51-12.19]; p = 0.006). In the matched population, this effect was attenuated (24% vs. 12%, HR 95%CI 2.09 [0.61-7.23]; p = 0.243). Cumulative rate and risk of 1-year mortality did not differ in the entire (log-rank p = 0.069; 39% vs. 22%, HR 95%CI 1.99 [0.94-4.24]; p = 0.074) nor in the matched population (log-rank p = 0.520; 39% vs. 31%, HR 95%CI 1.34 [0.55-3.28]; p = 0.523). CONCLUSION: In patients with dLVEF undergoing TAVI, periprocedural pECMO support does not seem to improve patient outcome.

Differential Prognostic Value of Galectin-3 According to Carbohydrate Antigen 125 Levels in Transcatheter Aortic Valve Implantation.

INTRODUCTION AND OBJECTIVES: Galectin-3 (Gal-3) and carbohydrate antigen 125 (CA125) have been associated with adverse outcomes after transcatheter aortic valve implantation (TAVI). Experimental data have suggested a potential molecular interaction. Therefore, we assessed the association of Gal-3 and CA125 with prognosis after TAVI. METHODS: A total of 439 patients were enrolled. The primary endpoint was a composite of all-cause mortality or readmission for worsening heart failure after TAVI. RESULTS: The primary endpoint occurred in 16.4%. Gal-3 was dichotomized at ≥ 8.71 ng/mL into elevated and not elevated. Gal-3 was elevated in 31.9% and was associated with a higher risk of the primary endpoint (25% vs 12.4%, HR, 2.26; P<.001). After multivariable adjustment, the association of elevated Gal-3 with the primary endpoint was borderline significant (HR, 1.59; P=.068). CA125 was dichotomized at ≥ 18.4 U/mL, accordingly. CA125 was elevated in 51.9% and was also associated with a higher risk of the primary endpoint (25.4% vs 6.6%, HR, 4.20; P<.001). After multivariable adjustment, elevated CA125 (HR, 2.83; P=.001) remained independently associated with the primary endpoint. A differential prognostic effect of Gal-3 was found across CA125 status (P for interaction=.048). Elevated Gal-3 was associated with a higher risk of the primary endpoint when CA125 was elevated (38.8% vs 18.2%, HR, 2.02; P=.015) but lacked significance when CA125 was not elevated (6.6% vs 6.7%, HR, 1.16; P=.981). CONCLUSIONS: In patients undergoing TAVI, Gal-3 predicted adverse clinical outcomes only when CA125 was elevated.

Long-term effectiveness and safety of transcatheter closure of patent foramen ovale compared with antithrombotic therapy alone: a meta-analysis of six randomised clinical trials and 3,560 patients with reconstructed time-to-event data.

AIMS: Although three recent trials have shown a significant stroke risk reduction after tPFOc, the individual statistical power is limited and the impact on pooled evidence needs to be explored. We aimed to pool data from available randomised clinical trials (RCT) to assess whether tPFOc is more effective and safe than antithrombotic therapy alone (ATA). METHODS AND RESULTS: Major electronic databases and tangential sources were searched. Six trials (3,560 patients) were identified. At a median follow-up of 3.6 (2.0-5.2) years (13,930 person-years), the risk of stroke was significantly lower after tPFOc compared with ATA (HR 0.28, 95% CI: 0.12-0.64, p=0.003). Significant heterogeneity was detected (I2=66.1%), although single trials did not significantly influence the results. Reconstructed time-to-event data revealed that tPFOc benefits accrue after approximately one year and persist over time without significant variations (96.4% versus 88.0%; HR 0.25, 95% CI: 0.09-0.66, p=0.005; NNT=11). Although results showed a greater benefit in patients <45 years old, male, and with substantial shunt, interaction between subgroups was not significant. Trial sequential analysis showed that accumulated evidence appeared to be sufficient. However, tPFOc did not confer protection against transient ischaemic attack (TIA; HR 0.69, 95% CI: 0.31-1.54, p=0.365) and a significant excess in the risk of atrial fibrillation was observed (OR 4.99, 95% CI: 1.99-10.10, p<0.001), though generally early and transient. Major bleeding and migraine were comparable between treatments. CONCLUSIONS: Compared with ATA, tPFOc significantly reduces the risk of stroke at long-term follow-up but no benefit is observed in terms of TIA. Atrial fibrillation is higher after tPFOc, though generally early and transient. The risks of major bleeding and migraine are comparable between the groups.

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

AIMS: 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. METHODS AND RESULTS: 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. CONCLUSIONS: 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.

Incidental findings in multislice computed tomography prior to transcatheter aortic valve implantation: frequency, clinical relevance and outcome.

Multislice computed tomography (MSCT) has emerged as the mainstay in patients planned for transcatheter aortic valve implantation (TAVI). Incidental findings (IF) in MSCT are common. However, the exact incidence, clinical relevance and further consequences of IF are unclear and it is controversial whether IF adversely affect patients' outcome. We analyzed MSCT data of 1050 patients screened for TAVI between January 2011 and December 2014. Median follow-up of patients was 20 months. In total, 3194 IF were identified, which were classified into clinically non-relevant IF (2872, 90%) and clinically relevant IF (322, 10%). In 25% of patients (258/1050) at least one clinically relevant IF was present. Age (80 ± 7 vs. 80 ± 7 years; p = 0.198) and EuroSCORE II (3.6% [2.1-5.7] vs. 3.6% [2.1-5.9]; p = 0.874) was similar between patients with and without a clinically relevant IF. TAVI was performed less frequently in patients with a clinically relevant IF (76% vs. 85%; p < 0.001), with more patients receiving surgical aortic valve replacement in that group (14% vs. 11%; p = 0.042), possibly due to the high rate of incidental aneurysms of the ascending aorta (n = 48). If TAVI was performed mortality did not differ (30-days: 4% vs. 3%; p = 0.339, 1-year: 11% vs. 14%; p = 0.226) between patients with and without a clinically relevant IF. Our study is the largest study to analyze prevalence, clinical relevance and therapeutic consequences of IF during screening for TAVI. IF in pre-procedural MSCT are common and clinically relevant in one-quarter of patients. However, these findings had no impact on overall mortality.

Comparison of Carbohydrate Antigen 125 and N-Terminal Pro-Brain Natriuretic Peptide for Risk Prediction After Transcatheter Aortic Valve Implantation.

Elevated carbohydrate antigen 125 (CA125) and N-terminal pro-brain natriuretic peptide (NTproBNP) have been associated with adverse outcome after transcatheter aortic valve implantation (TAVI). This study performs a comparison of both biomarkers for prognosis after TAVI. The study includes 363 patients. The primary end point was all-cause death or readmission for worsening congestive heart failure within 1 year after TAVI, and this end point occurred in 16% of the population. The optimal cutoff to predict the primary end point was 18.4 U/ml for CA125 and 2,570 ng/L for NTproBNP. Elevated CA125 levels were present in 52% and were associated with a higher rate of the primary end point (27% vs 3%; p <0.001). In parallel, elevated NTproBNP levels were present in 42% and were also associated with a higher rate of the primary end point (27% vs 8%; p <0.001). After multivariable adjustment, elevated CA125 (hazard ratio [HR] 5.26; p <0.001) and elevated NTproBNP (HR 2.12; p = 0.022) were independent predictors of the primary end point. To explore the utility of combining both biomarkers, CA125 was added to the model containing baseline variables and NTproBNP. Elevated CA125 (HR 4.62; p = 0.001), but not NTproBNP (HR 1.58; p = 0.194), persisted as an independent predictor of the primary end point. Addition of CA125 significantly improved the predictive capability of the model (C-statistic: 0.805 vs 0.776) and the net reclassification index (50%, 95% confidence interval [20 to 84]) with an integrated discriminative improvement of 3.0%. In conclusion, elevated CA125 and NTproBNP predict adverse clinical outcome after TAVI. However, when combining both biomarkers, the predictive capacity of CA125 was superior.

Emergency extracorporeal membrane oxygenation in transcatheter aortic valve implantation: A two-center experience of incidence, outcome and temporal trends from 2010 to 2015.

BACKGROUND: Although the incidence of periprocedural complications has decreased in transcatheter aortic valve implantation (TAVI), life-threatening complications occur and emergency veno-arterial extracorporeal membrane oxygenation (vaECMO) can provide immediate circulatory stabilization. We report our two-center experience of vaECMO during life-threatening complications in TAVI. METHODS: From January 2010 to December 2015, 1,810 consecutive patients underwent TAVI at two centers. Clinical characteristics, type of complication, outcome and temporal trends in the requirement of emergency vaECMO were evaluated. RESULTS: Life-threatening complications requiring vaECMO occurred in 1.8% of cases (33 patients; 22 transfemoral, 11 transapical). Indications for vaECMO were ventricular rupture (30%, 10/33), low output (15%, 5/33), bleeding (12%, 4/33), coronary artery impairment (9%, 3/33), ventricular arrhythmias (6%, 2/33), severe aortic regurgitation (6%, 2/33), aortic annular rupture (6%, 2/33), and aortic dissection (3%, 1/33). In 4 cases, no definite cause for hemodynamic instability was identified. Conversion to open heart surgery was necessary in 42% of patients (14/33). Percutaneous coronary intervention was performed in all cases with coronary artery impairment (9%, 3/33). Patients with severe aortic regurgitation (6%, 2/33) underwent emergency valve-in-valve implantation. Other patients received, in addition to vaECMO support conservative treatment (42%, 14/33). In-hospital mortality and 30-day mortality were 46% (15/33). Of patients discharged, 67% (12/18) had no neurological impairment, whereas mild and severe neurological impairment was found in 11% (2/18) and 22% (4/18), respectively. From 2010 to 2015, with increasing procedures (from n = 43 to n = 553) requirement of vaECMO decreased from 9.3% to 0.9% (P for the trend <0.001). CONCLUSION: Over a 6-year period, need for emergency vaECMO during TAVI significantly decreased over time. Despite high in-hospital mortality, vaECMO represents a feasible strategy for hemodynamic support in case of life-threatening complications.

Clipping through a mirror: First reported successful MitraClip in a patient with dextrocardia.

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Multicenter Comparison of Novel Self-Expanding Versus Balloon-Expandable Transcatheter Heart Valves.

OBJECTIVES: This study sought to compare 2 next-generation transcatheter heart valves (THV), the self-expanding ACURATE neo (NEO) and the balloon-expandable SAPIEN 3 (S3), in terms of device failure and early safety at 30 days. BACKGROUND: Deployment of these THV showed promising initial clinical results. However, no comparative data are available. METHODS: Of 1,121 treated patients at 3 centers, a 1-to-2 nearest neighbor matching was performed to identify 2 patients treated with S3 (n = 622) for each patient treated with NEO (n = 311). RESULTS: In-hospital complications were comparable between NEO and S3, including stroke (1.9% vs. 2.4%; p = 0.64), major vascular complications (10.3% vs. 8.5%; p = 0.38), or life-threatening bleeding (4.2% vs. 3.7%; p = 0.72). Device failure with NEO was comparable with S3 (10.9% vs. 9.6%; odds ratio: 1.09 [95% confidence interval: 0.69 to 1.73]; p = 0.71) with more paravalvular leakage (PVL II+, 4.8% vs. 1.8%; p = 0.01), but less elevated gradients (≥20 mm Hg, 3.2% vs. 6.9%; p = 0.02) and pacemaker implantations (9.9% vs. 15.5%; p = 0.02). Thirty-day mortality (2.3% vs. 1.9%; p = 0.74) and the early safety composite endpoint (15.8% vs. 15.6%; hazard ratio: 0.97 [95% confidence interval: 0.68 to 1.39]; p = 0.88) were similar with NEO and S3. CONCLUSIONS: Very high success rates were achieved for both valves, and the clinical and procedural results were comparable. Compared with S3, NEO was associated with less new pacemaker implantations and less elevated gradients, but with more paravalvular leakage.