Outcomes after transcatheter mitral valve implantation in valve-in-valve, valve-in-ring, and valve-in-mitral annular calcification.

AIMS: We aimed to evaluate transcatheter mitral valve implantation (TMVI) using predominantly balloon-expandable transcatheter heart valves (THV) in patients with a landing zone for a percutaneously delivered prosthesis. BACKGROUND: Patients with a degenerated mitral valve bioprosthesis, annuloplasty ring, and mitral annulus calcification (MAC) considered at high surgical risk currently represent a treatment challenge. TMVI is an alternative treatment option. METHODS: Retrospective analysis of patients with symptomatic degenerated mitral valve bioprosthesis, or annuloplasty ring, and MAC treated with TMVI between November 2011 and April 2021. Endpoints were defined according to Mitral Valve Academic Research Consortium (MVARC) criteria and included device and procedure success at 30 days as well as mortality at 30 days and 1 year after the procedure. RESULTS: A total of 77 patients underwent TMVI (valve in valve [ViV = 56], valve in ring [ViR = 11], and valve in MAC [ViMAC = 10]). There was a trend toward higher technical success (all = 93.5%, ViV = 96.4%, ViR = 90.9%, ViMAC = 80%, p = 0.06) and lower 30-day (all = 11.7%, ViV = 10.7%, ViR = 9.1%, ViMAC = 20%, p = 0.49) and 1-year mortality (all = 26%, ViV = 23.2%, ViR = 27.3%, ViMAC= 40%, p = 0.36) after ViV and ViR compared to ViMAC. CONCLUSION: TMVI represents a reasonable treatment option in selected patients with MAC or who are poor candidates for redo mitral valve surgery. Technical success and survival up to 1 year were not significantly dependent on the subgroup in which TMVI was performed.

Comparison of angiographic result and long-term outcome in patients with in-stent restenosis treated with cutting balloon or with scoring balloon angioplasty.

BACKGROUND: Lesion preparation with a cutting (CB) or scoring balloon (SB) is often used in patients with in-stent restenosis (ISR). However, there are no comparative studies. METHODS: We analyzed 81 patients (CB group: n = 38; SB group: n = 43) who had a calcified ISR from November 2019 to September 2021. The primary endpoint was strategy success (less than 20% residual stenosis); the secondary endpoints were major adverse cardiovascular events during the 1-year follow-up. Quantitative coronary angiography was performed to evaluate the strategy success. RESULTS: The patients in the CB group were more likely to have a severe calcified ISR (P = .001) and multiple stent layers (P = .001). A total of 64 patients (79.0%) reached the primary endpoint. Residual stenosis greater than 20% was more common in the CB group (39.5% vs 4.7%; P = .001). In the multivariate analysis, an effect of the intervention group on the achievement of the primary endpoint could be excluded (estimate 1.06; standard error 1.07; P = .322). The time interval of stent implantation prior to CB/SB (P = .007) and severe calcified ISR (P = .009) had a negative impact on reaching the primary endpoint. During the follow-up, there were no differences in rates of cardiac death (CB 2.5% vs. SB 1.2%; P = .598), acute myocardial infarction (CB 0% vs. SB 4.9%; P = .119), and target lesion failure (CB 3.7% vs SB 12.3%; P = .074). CONCLUSIONS: In our cohort, multivariate analysis showed that lesion preparation with CB or SB must be considered equivalent in terms of angiographic results. Factors like severe calcified ISR and the time interval of prior stent implantation negatively influenced the angiographic outcome.

Characterization and Management of Stable Coronary Artery Disease in Patients Undergoing Transcatheter Aortic Valve Implantation.

Background/Objectives: To date, data regarding the characteristics and management of obstructive, stable coronary artery disease (CAD) encountered in patients undergoing transcatheter aortic valve implantation (TAVI) are sparse. The aim of the study was to analyze granular details, treatment, and outcomes of patients undergoing TAVI with obstructive, stable CAD from real-world practice. Methods: REVASC-TAVI (Management of myocardial REVASCularization in patients undergoing Transcatheter Aortic Valve Implantation with coronary artery disease) is an investigator-initiated, multicenter registry, which collected data from patients undergoing TAVI with obstructive stable CAD found during the pre-TAVI work-up. Results: A total of 2025 patients from 30 centers worldwide with complete follow-up were included in the registry. Most patients had single-vessel CAD (56.1%). An involvement of proximal coronary tracts was detected in 62.5% of cases, with 12.0% of patients having CAD in left main (LM). Most patients received percutaneous coronary intervention (PCI) (n = 1617, 79.9%), especially those with proximal CAD (90.4%). At 2 years, the rates of all-cause death [Kaplan-Meier (KM) estimates 20.1% vs. 18.8%, plog-rank = 0.86] and of the composite of all-cause death, stroke, myocardial infarction, and rehospitalization for heart failure (KM estimates 29.7% vs. 27.5%, plog-rank = 0.82) did not differ between patients undergoing PCI and those who were not. Conclusions: Patients undergoing TAVI with obstructive CAD more commonly had a single-vessel disease and an involvement of proximal coronary tracts. They were commonly treated with PCI, with similar outcomes compared to those treated conservatively.

Timing of multivessel revascularization in stable patients with STEMI: a systematic review and network meta-analysis.

INTRODUCTION AND OBJECTIVES: Multivessel percutaneous coronary intervention (MV-PCI) is recommended in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease (CAD) without cardiogenic shock. The present network meta-analysis investigated the optimal timing of MV-PCI in this context. METHODS: We pooled the aggregated data from randomized trials investigating stable STEMI patients with multivessel CAD treated with a strategy of either MV-PCI or culprit vessel-only PCI. The primary outcome was all-cause death. The main secondary outcomes were cardiovascular death, myocardial infarction, and unplanned ischemia-driven revascularization. RESULTS: Among 11 trials, a total of 10 507 patients were randomly assigned to MV-PCI (same sitting, n=1683; staged during the index hospitalization, n=3460; staged during a subsequent hospitalization within 45 days, n=3275) or to culprit vessel-only PCI (n=2089). The median follow-up was 18.6 months. In comparison with culprit vessel-only PCI, MV-PCI staged during the index hospitalization significantly reduced all-cause death (risk ratio, 0.73; 95%CI, 0.56-0.92; P=.008) and ranked as possibly the best treatment option for this outcome compared with all other strategies. In comparison with culprit vessel-only PCI, a MV-PCI reduced cardiovascular mortality without differences dependent on the timing of revascularization. MV-PCI within the index hospitalization, either in a single procedure or staged, significantly reduced myocardial infarction and unplanned ischemia-driven revascularization, with no significant difference between each other. CONCLUSIONS: In patients with STEMI and multivessel CAD without cardiogenic shock, multivessel PCI within the index hospitalization, either in a single procedure or staged, represents the safest and most efficacious approach. The different timings of multivessel PCI did not result in any significant differences in all-cause death. This study is registered at PROSPERO (CRD42023457794).

Incidence, Predictors, and Outcomes of Paravalvular Regurgitation After TAVR in Sievers Type 1 Bicuspid Aortic Valves.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BAV) stenosis is technically challenging and is burdened by an increased risk of paravalvular regurgitation (PVR). OBJECTIVES: The aim of this study was to identify the incidence, predictors, and clinical outcomes of PVR after TAVR in Sievers type 1 BAV stenosis. METHODS: Consecutive patients with Sievers type 1 BAV stenosis undergoing TAVR with current-generation transcatheter heart valves (THVs) in 24 international centers were enrolled. PVR was graded as none/trace, mild, moderate, and severe according to echocardiographic criteria. The endpoint of major adverse events (MAEs), defined as a composite of all-cause death, stroke, or hospitalization for heart failure, was assessed at the last available follow-up. RESULTS: A total of 946 patients were enrolled. PVR occurred in 423 patients (44.7%)-mild, moderate, and severe in 387 (40.9%), 32 (3.4%), and 4 (0.4%) patients, respectively. Independent predictors of moderate or severe PVR were a larger virtual raphe ring perimeter (adjusted OR: 1.07; 95% CI: 1.02-1.13), severe annular or left ventricular outflow tract calcification (adjusted OR: 5.21; 95% CI: 1.45-18.77), a self-expanding valve (adjusted OR: 9.01; 95% CI: 2.09-38.86), and intentional supra-annular THV positioning (adjusted OR: 3.31; 95% CI: 1.04-10.54). At a median follow-up of 1.3 years (Q1-Q3: 0.5-2.4 years), moderate or severe PVR was associated with an increased risk of MAEs (adjusted HR: 2.52; 95% CI: 1.24-5.09). CONCLUSIONS: After TAVR with current-generation THVs in Sievers type 1 BAV stenosis, moderate or severe PVR occurred in about 4% of cases and was associated with an increased risk of MAEs during follow-up.

Short-Term Outcomes of ACURATE neo2.

Inferior outcomes with ACURATE neo, a self-expanding transcatheter heart valve (THV) for the treatment of severe aortic stenosis, were mainly driven by higher rates of moderate/severe paravalvular leak (PVL). To overcome this limitation, the next-generation ACURATE neo2 features a 60% larger external sealing skirt. Data on long-term performance are limited; however, clinical evidence suggests improved short-term performance which is comparable to contemporary THVs. This report reviews data on short-term clinical and echocardiographic outcomes of ACURATE neo2. A PubMed search yielded 13 studies, including 5 single arm and 8 nonrandomized comparative studies with other THVs which reported in-hospital or 30-day clinical and echocardiographic outcomes. In-hospital or 30-day all-cause mortality was ≤3.3%, which is comparable to other contemporary THVs. The rates of postprocedural ≧moderate PVL ranged 0.6%-4.7%. In multicenter propensity-matched analyses, neo2 significantly reduced the rate of ≧moderate PVL compared to neo (3.5% vs. 11.3%, p < 0.01), whereas rates were comparable to Evolut Pro/Pro+ (Neo2: 2.0% vs. Pro/Pro+: 3.1%, p = 0.28) and SAPIEN 3 Ultra (Neo2: 0.6% vs. Ultra: 1.1%, p = 0.72). The rate of permanent pacemaker implantation with neo2 was consistently low (3.3%-8.6%) except in one study, and in propensity-matched analyses were significantly lower than Evolut Pro/Pro+ (6.7% vs. 16.7%, p < 0.01), and comparable to SAPIEN 3 Ultra (8.1% vs. 10.3%, p = 0.29). In conclusion, ACURATE neo2 showed better short-term performance by considerably reducing PVL compared to its predecessor, with short-term clinical and echocardiographic outcomes comparable to contemporary THVs.

Invasive Assessment of Right Ventricular to Pulmonary Artery Coupling Improves 1-year Mortality Prediction After Transcatheter Aortic Valve Replacement and Anticipates the Persistence of Extra-Aortic Valve Cardiac Damage.

Background: The interplay between the right ventricle and the pulmonary artery, known as right ventricular to pulmonary artery (RV-PA) coupling, is crucial for assessing right ventricular systolic function against the afterload from the pulmonary circulation. Pulmonary artery pressure levels are ideally measured by right heart catheterization. Yet, echocardiography represents the most utilized method for evaluating pulmonary artery pressure levels, albeit with limitations in accuracy. This study therefore aims to evaluate the prognostic significance of right ventricular to pulmonary artery (RV-PA) coupling expressed as tricuspid annular plane systolic excursion (TAPSE) related to systolic pulmonary artery pressure (sPAP) levels measured by right heart catheterization (TAPSE/sPAPinvasive) or estimated by transthoracic echocardiography (TAPSE/sPAPechocardiography) in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR). Methods: Using data from a bicentric registry, this study compares TAPSE/sPAPinvasive vs. TAPSE/sPAPechocardiography in predicting 1-year all-cause mortality after TAVR. Results: Among 333 patients with complete echocardiography and right heart catheterization data obtained before TAVR, their mean age was 79.8 ± 6.74 years, 39.6% were female, and general 1-year survival was 89.8%. sPAPinvasive and sPAPechocardiography showed only moderate correlation (Pearson correlation coefficient R: 0.53, p value: <0.0001). TAPSE/sPAPinvasive was superior to TAPSE/sPAPechocardiography in predicting 1-year all-cause mortality after TAVR (area under the curve: 0.662 vs. 0.569, p value: 0.025). Patients with reduced TAPSE/sPAPinvasive levels (< 0.365 mm/mmHg) evidenced significantly lower 1-year survival rates than patients with preserved TAPSE/sPAPinvasive levels (81.8 vs. 93.6%, p value: 0.001; hazard ratio for 1-year mortality: 3.09 [95% confidence interval: 1.55-6.17]). Echocardiographic follow-up data revealed that patients with reduced RV-PA coupling suffer from persistent right ventricular dysfunction (TAPSE: 16.6 ± 4.05 mm vs. 21.6 ± 4.81 mm in patients with preserved RV-PA coupling) and severe tricuspid regurgitation (diagnosed in 19.7 vs. 6.58% in patients with preserved RV-PA coupling). Conclusions: RV-PA coupling expressed as TAPSE/sPAPinvasive can refine stratification of severe aortic stenosis patients into low-risk and high-risk cohorts for mortality after TAVR. Moreover, it can help to anticipate persistent extra-aortic valve cardiac damage, which will demand further treatment.

Comparison of two self-expanding transcatheter heart valves for degenerated surgical bioprostheses: the AVENGER multicentre registry.

BACKGROUND: There is a lack of comparative data on transcatheter aortic valve implantation (TAVI) in degenerated surgical prostheses (valve-in-valve [ViV]). AIMS: We sought to compare outcomes of using two self-expanding transcatheter heart valve (THV) systems for ViV. METHODS: In this retrospective multicentre registry, we included consecutive patients undergoing transfemoral ViV using either the ACURATE neo/neo2 (ACURATE group) or the Evolut R/PRO/PRO+ (EVOLUT group). The primary outcome measure was technical success according to Valve Academic Research Consortium (VARC)-3. Secondary outcomes were 30-day all-cause mortality, device success (VARC-3), coronary obstruction (CO) requiring intervention, rates of severe prosthesis-patient mismatch (PPM), and aortic regurgitation (AR) ≥moderate. Comparisons were made after 1:1 propensity score matching. RESULTS: The study cohort comprised 835 patients from 20 centres (ACURATE n=251; EVOLUT n=584). In the matched cohort (n=468), technical success (ACURATE 92.7% vs EVOLUT 88.9%; p=0.20) and device success (69.7% vs 73.9%; p=0.36) as well as 30-day mortality (2.8% vs 1.6%; p=0.392) were similar between the two groups. The mean gradients and rates of severe PPM, AR ≥moderate, or CO did not differ between the groups. Technical and device success were higher for the ACURATE platform among patients with a true inner diameter (ID) >19 mm, whereas a true ID ≤19 mm was associated with higher device success - but not technical success - among Evolut recipients. CONCLUSIONS: ViV TAVI using either ACURATE or Evolut THVs showed similar procedural outcomes. However, a true ID >19 mm was associated with higher device success among ACURATE recipients, whereas in patients with a true ID ≤19 mm, device success was higher when using Evolut.

Lower revascularization rates after high-speed rotational atherectomy compared to modified balloons in calcified coronary lesions: 5-year outcomes of the randomized PREPARE-CALC trial.

BACKGROUND: In the PREPARE-CALC trial, severely calcified lesion preparation with rotational atherectomy (RA) before biodegradable polymer sirolimus-eluting stent (SES) implantation demonstrated higher procedural success and comparable rates of acute lumen gain and late lumen loss compared to modified balloons (MB) (scoring/cutting). We aimed to analyze the 5-year outcomes of both lesion preparation strategies. METHODS: PREPARE-CALC randomly assigned 200 patients 1:1 to MB or RA, followed by SES implantation. The principal endpoint of the current analysis was target vessel failure (TVF) at 5 years. RESULTS: At 5 years, MB had comparable rates of TVF to RA (19% vs. 21%, HR 1.14, 95% CI 0.60-2.16, p = 0.687). Subgroup analysis showed a lesion length treatment interaction, favoring MB for short lesions and RA for long ones (p for interaction = 0.042). Target lesion revascularization (TLR) was significantly less common with RA (12 vs. 3%, HR 0.28, 95% CI 0.08-0.98, p = 0.048). In a multivariate analysis, RA was independently protective against TLR (adj. HR 0.17, 95% CI 0.04-0.78, p = 0.022), while ostial lesions were associated with higher TLR independent of treatment strategy (adj. HR 11.3, 95% CI 2.98-42.6, p < 0.001). CONCLUSION: In patients with severely calcified coronary lesions, using MB or RA for lesion preparation followed by biodegradable polymer SES implantation was associated with comparable rates of TVF at 5 years. However, a significant reduction of TLR was observed after RA. PREPARE-CALC is the first randomized trial showing potential clinical advantages of RA over MB during long-term follow-up. CLINICAL TRIAL REGISTRATION: URL: https://www. CLINICALTRIALS: gov . Unique identifier: NCT02502851.

[Update on the treatment of aortic valve stenosis in symptomatic and asymptomatic patients]. / Update zur Behandlung der Aortenklappenstenose bei symptomatischen und asymptomatischen Patienten.

Aortic valve stenosis is one of the most frequent valvular heart diseases requiring treatment in industrialized countries. The symptom onset is associated with a significantly increased mortality, so that there is a clear indication for treatment in patients with severe, symptomatic aortic valve stenosis; however, data on the optimal treatment of patients with asymptomatic aortic valve stenosis are scarce. Smaller studies in the field of cardiac surgery suggest that early surgical valve replacement is superior to a conservative approach. For this reason, the results of additional adequately powered randomized trials are awaited with great interest. In this year numerous long-term results from randomized comparisons of the two available treatment options (surgical versus transcatheter aortic valve replacement) were published, which will further guide the heart team to find the best treatment approach for each individual.

ACURATE neo2 Transcatheter aortic valve implantation without balloon aortic valvuloplasty - direct ACURATE neo2.

BACKGROUND: ACURATE neo2 (Neo2) implantation is performed after systematic Balloon Aortic Valvuloplasty (BAV) in most patients. No reports exist about the feasibility and safety of direct Neo2 transcatheter aortic valve implantation (TAVI) in comparison to the standard practice. AIM: We aimed to identify the patients' baseline anatomical characteristics, procedural, and early post-procedural outcomes in patients treated using Neo2 with and without BAV. METHODOLOGY: This is a retrospective multicentre analysis of 499 patients with severe aortic stenosis who underwent TAVI using Neo2. The comparison was done according to the performance or omission of BAV. Echocardiography and computed tomography were analysed by an independent Core Lab. Propensity score matching (PSM) was performed based on the annular diameter and AV calcium volume, which identified 84 matched pairs. RESULTS: Among the cohort included, 391 (78%) patients received BAV (BAV-yes) and 108 (22%) were not attempted (BAV-no or Direct TAVI). Patients in BAV-no cohort had smaller annular diameter (22.6 vs 23.4 mm; p < 0.001) and lower calcium volume (163 vs 581 mm3; p < 0.001) compared to BAV-yes cohort. In the matched cohort, VARC-3 device technical success was similar (95%) and all other outcome measures were statistically comparable between cohorts. CONCLUSION: Direct TAVI using ACURATEneo2 without pre-TAVI balloon aortic valvuloplasty in patients with mild or less valve calcifications might be feasible and associated with comparable early outcomes compared to patients with similar anatomical features undergoing systematic balloon valvuloplasty.

Comparison of long-term outcome in patients with in-stent restenosis treated with intravascular lithotripsy or with modified balloon angioplasty.

BACKGROUND: Modified balloon angioplasty (MB) using a cutting-/scoring balloon or intravascular lithotripsy (IVL) is used in patients with in-stent restenosis (ISR). However, IVL is an off-label use in this setting. The aim of this subgroup analysis of an all-comers registry was to compare IVL to MB angioplasty in patients with ISR. METHODS: The subgroup (n = 117) included all patients with an ISR treated by MB or IVL between 2019 and 2021. Primary endpoint was strategy success (< 20% residual stenosis). The secondary endpoint was cardiac death, acute myocardial infarction (AMI) and target lesion failure/revascularization (TVR). Quantitative coronary angiography was performed in all patients. RESULTS: A total of n = 36 patients were treated by IVL and n = 81 patients by MB. No significant differences in baseline characteristics were observed between the groups. The primary endpoint was reached in 99 patients (84.6%). Patients in the IVL group had less residual stenosis (2.8% vs. 21.0%; p = 0.012). Multivariate regression analysis revealed that IVL had a significant positive effect on reaching the primary end point (Estimate 2.857; standard error (SE) 1.166; p = 0.014). During the follow-up period (450 days) there were no significant differences in rates of cardiac death (IVL n = 2 (1.7%) vs. MB n = 3 (2.6%); p = 0.643), AMI (IVL n = 2 (1.7%) vs. MB n = 4 (3.4%); p = 0.999) and TVR (IVL n = 5 (4.3%) vs. MB n = 14 (12%); p = 0.851). CONCLUSION: IVL results in a significantly lower rate of residual stenosis than MB in patients with ISR. During the long-term follow-up, no differences in rates of cardiac death, AMI or TVR were observed.

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

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

Predictores de necesidad de marcapasos permanente y alteraciones de la conducción con el implante transcatéter de una nueva válvula aórtica autoexpandible / Predictors of need for permanent pacemaker implantation and conduction abnormalities with a novel self-expanding transcatheter heart valve

Introducción y objetivos: La incidencia de implante de marcapasos permanente (IMP) y nuevas alteraciones de la conducción (AC) con la ACURATE neo (Symetis S.A., Eclubens, Suiza) no se ha estudiado en detalle. Nuestro objetivo fue analizar sus predictores, evaluándose los factores relacionados con el paciente y con el dispositivo, tal como la profundidad del implante y la relación entre el dispositivo y el anillo (RDA). Métodos: De una población multicéntrica, se realizaron 2 análisis: nuevos IMP (n = 283), e IMP/nuevas AC en pacientes sin AC previas o marcapasos (n = 232). Resultados: En el 9,9% de los pacientes se necesitó nuevo IMP, que se asoció con un mayor índice de masa corporal, mayor proporción de bloqueo de rama derecha y bradicardia. Ni el implante de la prótesis ni la RDA difirieron entre pacientes con o sin IMP. En el análisis multivariante ni la RDA (OR = 1,010; IC95%, 0,967-1,055; p = 0,7), ni la profundidad del implante (OR = 0,972; IC95%, 0,743-1,272; p = 0,8) fueron predictores de IMP. Solo el índice de masa corporal, la bradicardia y el bloqueo de rama derecha persistieron como predictores independientes. El IMP/nueva aparición de AC ocurrió en el 22,8% de los pacientes y se asoció con un mayor EuroSCORE logístico. Ni la profundidad del implante ni la RDA eran diferentes en pacientes con o sin IMP/nueva aparición de AC (7,3 ± 1,9 frente a 7,1 ± 1,5 mm; p = 0,6 y 41,0 ± 7,9 frente a 42,2 ± 10,1%; p = 0,4). El único predictor de IMP/nuevo inicio de AC fue un mayor EuroSCORE logístico (OR = 1,039; IC95%, 1,008-1,071; p = 0,013). Conclusiones: La proporción de nuevos IMP y nueva aparición de AC eran inferiores con la ACURATE neo. Estos hechos están principalmente influenciados por las características de los pacientes y no por los factores dependientes del dispositivo

Introduction and objectives: The incidence of permanent pacemaker implantation (PPI) and new conduction abnormalities (CA) with the ACURATE neo (Symetis S.A., Eclubens, Switzerland) has not been studied in detail. We aimed to analyze their predictors, evaluating patient- and device-related factors, including implantation depth and device-to-annulus ratio (DAR). Methods: Two analyses of a multicenter population were performed: new PPI in pacemaker-naive patients (n = 283), and PPI/new-CA in patients without prior CA or pacemaker (n = 232). Results: A new PPI was required in 9.9% of patients, who had a higher body mass index, higher rate of right bundle branch block and bradycardia. Neither implantation depth nor DAR differed in patients with PPI compared with those without. In the multivariable analysis neither DAR (OR, 1.010; 95%CI, 0.967-1.055; P = .7) nor implantation depth (OR, 0.972; 95%CI, 0.743-1.272; P = .8) predicted PPI. Only high body mass index, bradycardia and right bundle branch block persisted as independent predictors. PPI/new-onset CA occurred in 22.8% of patients and was associated with a higher logistic EuroSCORE. Neither implantation depth nor DAR differed in patients with PPI/new-CA vs those without (7.3 ± 1.9 vs 7.1 ± 1.5 mm; P = .6 and 41.0 ± 7.9 vs 42.2 ± 10.1%; P = .4). The only predictor of PPI/new-CA was a higher logistic EuroSCORE (OR, 1.039; 95%CI, [1.008-1.071]; P = .013). Conclusions: New PPI and new-onset CA rates were low with the ACURATE neo. These were mainly influenced by patient characteristics and not by device-depending factors