One-year outcomes after transcatheter aortic valve implantation with the latest-generation SAPIEN balloon-expandable valve: the S3U registry.

BACKGROUND: Initial data about the performance of the new-generation SAPIEN 3 Ultra (S3U) valve are highly promising. However, evidence about the longer-term performance and safety of the S3U is scarce. AIMS: We aimed to investigate the 1-year clinical and echocardiographic outcomes of transcatheter aortic valve implantation (TAVI) using the S3U compared with its predecessor, the SAPIEN 3 valve (S3). METHODS: The SAPIEN 3 Ultra registry included consecutive patients who underwent transfemoral TAVI at 12 European centres with the S3U or S3 between October 2016 and December 2020. One-to-one propensity score (PS) matching was performed to account for differences in baseline characteristics. The primary outcomes of interest were all-cause death and the composite of all-cause death, disabling stroke and hospitalisation for heart failure at 1 year. RESULTS: The overall study cohort encompassed 1,692 patients treated with either the S3U (n=519) or S3 (n=1,173). The PS-matched population had a total of 992 patients (496 per group). At 1 year, the rate of death from any cause was 4.9% in the S3U group and 6.3% in the S3 group (p=0.743). Similarly, there were no significant differences in the rates of the primary composite outcome (9.5% in the S3 group and 6.6% in the S3U group; p=0.162). The S3U was associated with lower rates of mild paravalvular leak (PVL) compared with the S3 (odds ratio 0.63, 95% confidence interval: 0.44 to 0.88; p<0.01). No significant differences in transprosthetic gradients were observed between the two groups. CONCLUSIONS: Compared with the S3, the S3U transcatheter heart valve was associated with similar 1-year clinical outcomes but reduced rates of mild PVL.

Center Valve Preference and Outcomes of Transcatheter Aortic Valve Replacement: Insights From the AMTRAC Registry.

BACKGROUND: Data on outcomes of transcatheter aortic valve replacement (TAVR) using balloon-expandable valves (BEVs) or self-expandable valves (SEVs) as well as the impact of center valve preference on these outcomes are limited. OBJECTIVES: The aim of this study was to compare outcomes of TAVR procedures using third-generation BEVs and SEVs stratified by center valve preference. METHODS: In a multicenter registry (n = 17), 13 centers exhibited valve preference (66.6%-90% of volume) and were included. Outcomes were compared between BEVs and SEVs stratified by center valve preference. RESULTS: In total, 7,528 TAVR procedures (3,854 with SEVs and 3,674 with BEVs) were included. The mean age was 81 years, and the mean Society of Thoracic Surgeons score was 5.2. Baseline characteristics were similar between BEVs and SEVs. Need for pacemaker implantation was higher with SEVs at BEV- and SEV-dominant centers (17.8% vs 9.3% [P < 0.001] and 12.7% vs 10.0% [P = 0.036], respectively; HR: 1.51; P for interaction = 0.021), risk for cerebrovascular accident was higher with SEVs at BEV-dominant but not SEV-dominant centers (3.6% vs 1.1% [P < 0.001] and 2.2% vs 1.4% [P = 0.162]; HR: 2.08; P for interaction < 0.01). Aortic regurgitation greater than mild was more frequent with SEVs at BEV-dominant centers and similar with BEVs regardless of center dominance (5.2% vs 2.8% [P < 0.001] and 3.4% vs 3.7% [P = 0.504], respectively). Two-year mortality was higher with SEVs at BEV-dominant centers but not at SEV-dominant centers (21.9% vs 16.9% [P = 0.021] and 16.8% vs 16.5% [P = 0.642], respectively; HR: 1.20; P for interaction = 0.032). CONCLUSIONS: Periprocedural outcomes, aortic regurgitation greater than mild, and 2-year mortality are worse when TAVR is performed using SEVs at BEV-dominant centers. Outcomes are similar regardless of valve type at SEV-dominant centers. The present results stress the need to account for this factor when comparing BEV and SEV outcomes. (The Aortic+Mitral Transcatheter [AMTRAC] Valve Registry; NCT04031274).

Development of atrioventricular and intraventricular conduction disturbances in patients undergoing transcatheter aortic valve replacement with new generation self-expanding valves: A real world multicenter analysis.

BACKGROUND: High degree cardiac conduction disturbances (HDCD) remain a major complication after transcatheter aortic valve replacement (TAVR), especially with self-expandable valves (SEV). Our aim was to investigate peri-procedural and in-hospital modification of atrioventricular and intracardiac conduction associated to new generation SEV implantation, and the development of new HDCD resulting in permanent pacemaker implantation (PPM) in patients undergoing TAVR. METHODS AND RESULTS: Three-hundred forty-four consecutive patients with severe aortic stenosis who underwent TAVR with a new generation SEV [Evolut-R/Pro (n = 130), Acurate-neo (n = 79), Portico (n = 75) and Allegra (n = 60)] were included. An analysis of baseline, post-TAVR and pre-discharge ECG and procedural aspects were centrally performed. A significant increase in baseline PR interval (169.6 ± 28.2 ms) and QRS complex width (101.7 ± 25.9 ms) was noted immediately post-TAVR (188.04 ± 34.49; 129.55 ± 30.02 ms), with a partial in-hospital reversal (179.4 ± 30.1; 123.06 ± 30.94 ms), resulting in a net increase at hospital discharge of 12.6 ± 38.8 ms and 21.4 ± 31.6 ms (p < 0.001), respectively. The global incidence of new onset persistent HDCD at hospital discharge was 46.3%, with 17.7% of patients requiring PPM. Independent predictors of new onset HCDC at hospital discharge were valve recapture (OR: 2.8; 95% IC: 1.1-7.2, p = 0.033) and implantation depth ≥ 6 mm (OR: 1.9 05% IC 1.1-3.3, p = 0.015), while higher implantation (<3 mm (OR: 0.3, 95% IC 0.1-0.7, p = 0.014) and use of Acurate-Neo valve (OR: 0.4; 95% IC 0.2-0.8, p = 0.009) were protective factor. CONCLUSIONS: New generation self-expanding aortic valves were associated with a significant increase in PR and QRS interval at hospital discharge leading to a very high rate of HDCD. While valve recapture and implantation depth were independent predictors for the occurrence of HDCD, use of Accurate-Neo valve was a protective factor.

Unplanned Hospital Readmissions After Transcatheter Aortic Valve Replacement in the Era of New-Generation Devices.

OBJECTIVES: Unplanned hospital readmissions after transcatheter aortic valve replacement (TAVR) are frequent and have been associated with a poor prognosis. We sought to determine the trends in the incidence and causes of unplanned hospital readmission after TAVR in patients receiving new-generation devices (NGDs) vs early-generation devices (EGDs). METHODS: The study population consisted of 1802 consecutive TAVR recipients (863 EGDs and 939 NGDs). Early and late readmissions were defined as those occurring ≤30 days and >30 days to 1-year post TAVR, respectively. RESULTS: A total of 986 unplanned hospital readmissions (cardiac cause, 38.4%; non-cardiac cause, 61.6%) were recorded at a median time of 110 days (interquartile range [IQR], 37-217) post TAVR. The rates of early (12.3% vs 9.4%; P=.046) and late (39.1% vs 31.6%; P<.01) readmission were lower in the NGD population. In the NGD group, major/life-threatening periprocedural bleeding (hazard ratio [HR], 2.40, 95% confidence interval [CI], 1.06-5.42; P=.04) and estimated glomerular filtration rate (eGFR) <60 mL/min at hospital discharge (HR, 1.80; 95% CI, 1.15-2.83; P=.01) were associated with an increased risk of early readmission post TAVR. Chronic obstructive pulmonary disease (HR, 1.42; 95% CI, 1.07-1.88; P=.02), eGFR <60 mL/min (HR, 1.43; 95% CI, 1.11-1.84; P<.01), and combining antiplatelet and anticoagulation therapy (HR, 1.37; 95% CI, 1.01-1.85; P=.04) determined an increased risk of late readmission. CONCLUSIONS: TAVR recipients receiving NGDs exhibited a significant but modest reduction in unplanned hospital readmissions, with about one-third of patients still requiring rehospitalization at 1-year follow-up in the contemporary TAVR era. Non-cardiac comorbidities, periprocedural bleeding events, and intensive antithrombotic therapy determined an increased risk.

Management and outcomes of patients with left atrial appendage thrombus prior to percutaneous closure.

OBJECTIVE: Left atrial appendage (LAA) thrombus has heretofore been considered a contraindication to percutaneous LAA closure (LAAC). Data regarding its management are very limited. The aim of this study was to analyse the medical and invasive treatment of patients referred for LAAC in the presence of LAA thrombus. METHODS: This multicentre observational registry included 126 consecutive patients referred for LAAC with LAA thrombus on preprocedural imaging. Treatment strategies included intensification of antithrombotic therapy (IAT) or direct LAAC. The primary and secondary endpoints were a composite of bleeding, stroke and death at 18 months, and procedural success, respectively. RESULTS: IAT was the preferred strategy in 57.9% of patients, with total thrombus resolution observed in 60.3% and 75.3% after initial and subsequent IAT, respectively. Bleeding complications and stroke during IAT occurred in 9.6% and 2.9%, respectively, compared with 3.8% bleeding and no embolic events in the direct LAAC group before the procedure. Procedural success was 90.5% (96.2% vs 86.3% in direct LAAC and IAT group, respectively, p=0.072), without cases of in-hospital thromboembolic complications. The primary endpoint occurred in 29.3% and device-related thrombosis was found in 12.8%, without significant difference according to treatment strategy. Bleeding complications at 18 months occurred in 22.5% vs 10.5% in the IAT and direct LAAC group, respectively (p=0.102). CONCLUSION: In the presence of LAA thrombus, IAT was the initial management strategy in half of our cohort, with initial thrombus resolution in 60% of these, but with a relatively high bleeding rate (~10%). Direct LAAC was feasible, with high procedural success and absence of periprocedural embolic complications. However, a high rate of device-related thrombosis was detected during follow-up.

Pre-dilation and Post-dilation in Transcatheter Aortic Valve Replacement: Indications, Benefits and Risks.

Transcatheter aortic valve replacement (TAVR) is an established treatment for patients with symptomatic severe aortic stenosis. In recent years, an emphasis has been placed on simplification of the procedure. Balloon predilation was initially considered a mandatory step to cross and prepare the stenotic aortic valve, but several studies demonstrated the feasibility of performing TAVR without balloon valvuloplasty. Balloon postdilation of the implanted valve is sometimes required to optimise results, although many patients do not require this step. Contemporary consensus advocates an individualised approach to TAVR procedures and so balloon pre- and post-dilation are performed selectively. This review aims to outline the advantages and disadvantages of balloon pre- and post-dilation and to identify the scenarios in which they are required during TAVR procedures.

Effect of Transcatheter Aortic Valve Replacement on Concomitant Mitral Regurgitation and Its Impact on Mortality.

OBJECTIVES: The purpose of this study was to examine the impact of residual mitral regurgitation (MR) on mortality in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: MR is common in patients undergoing TAVR. Data on optimal management of patients with significant MR after TAVR are limited. METHODS: The registry consisted of 16 TAVR centers (n = 7,303). Outcomes of patients with ≥ moderate versus lesser grade MR after TAVR were compared. RESULTS: In 1,983 (27.2%) patients, baseline MR grade was ≥ moderate. MR regressed in 874 (44.1%) patients and persisted in 1,109 (55.9%) after TAVR. Four-year mortality was higher for those with MR persistence, but not for those with MR regression after TAVR, compared with nonsignificant baseline MR (43.8% vs. 35.1% vs. 32.4%; hazard ratio [HR]: 1.38; p = 0.008; HR: 1.02; p = 0.383, respectively). New York Heart Association functional class III to IV after TAVR was more common in those with MR persistence vs. regression (14.4% vs. 3.9%; p < 0.001). In a propensity score-matched cohort (91 patients' pairs), with significant residual MR after TAVR who did or did not undergo staged mitral intervention, staged intervention was associated with a better functional class through 1 year of follow-up (82.4% vs. 33.3% New York Heart Association functional class I or II; p < 0.001), and a numerically lower 4-year mortality, which was not statistically significant (64.6% vs. 37.5%; HR: 1.66; p = 0.097). CONCLUSIONS: Risk stratification based on improvement in MR and symptoms after TAVR can identify patients at increased mortality risk after TAVR. These patients may benefit from a staged transcatheter mitral intervention, but this requires further proof from future studies. (Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter [AMTRAC] Valve Registry [AMTRAC]; NCT04031274).

Percutaneous mitral valve repair with MitraClip device in hemodynamically unstable patients: A systematic review.

BACKGROUND: Very few data exist on percutaneous mitral valve repair (PMVr) in unstable patients with concomitant moderate-severe mitral regurgitation (MR). The purpose of this systematic review was to evaluate baseline characteristics, management and clinical outcomes of critically ill patients undergoing PMVr with MitraClip. METHODS: We conducted a systematic review of the published data on MitraClip from its first use in 2003 to December 2020. Studies referring to critically ill patients in cardiogenic shock or acute refractory pulmonary edema were included. A total of 40 publications including 254 patients with significant MR (Grade 4 in 91%) were included. RESULTS: Mean age was 70 ± 12 years with mean Euroscore II and STS of 21 ± 13 and 20.5 ± 16, respectively. Clinical presentation was with cardiogenic shock and acute myocardial infarction in 72.8 and 60.0% of patients, respectively. Device success was achieved in 238 (93.7%) patients with a significant reduction in MR (Grade ≤ 2 in 91.8%, p < .001). The median weaning time from the procedure, to discontinuation of mechanical circulatory or respiratory support, was 2 days (IQR 1-4), with an in-hospital mortality and non-fatal complication rate of 12.6 and 9.1%, respectively. Kaplan-Meier curves estimated an overall mortality rate of 39.1% at 12-month follow-up, with persistent reduction in MR severity for survivors (Grade ≤ 2 in 81.3%) and one case of mitral valve reintervention. CONCLUSIONS: Percutaneous mitral valve repair with MitraClip device is a technically feasible and potentially viable management option in high-risk patients with cardiogenic shock or refractory pulmonary edema and concomitant moderate-severe MR. Prospective trials are required to confirm these findings, and definitively determine the value of MitraClip in hemodynamically unstable patients.

Impacto socioeconómico del manejo actual de la pancreatitis aguda de origen biliar severa: estudio comparativo / Socioeconomic impact of the current management of severe biliary acute pancreatitis: comparative study

RESUMEN Objetivo La pancreatitis aguda de origen biliar es una patología gastrointestinal común, en donde el tratamiento oportuno es el pilar más importante a pesar de sus discrepancias. El objetivo del estudio es establecer el impacto socioeconómico en el manejo actual de esta patología, comparando dos hospitales de tercer nivel de estrato socioeconómico alto y bajo de la ciudad de Bogotá, Colombia. Materiales y Métodos Se realizó un estudio retrospectivo, comparativo de corte transversal entre enero de 2012 y diciembre de 2017, en dos hospitales de Bogotá D. C. Se evaluaron sus características socioeconómicas, género, tiempo de evolución al momento de la consulta, Marshall score, estancia en UCI, estancia hospitalaria, complicaciones, manejo quirúrgico y mortalidad. Resultados Se analizaron 101 pacientes de dos estratos socioeconómicos diferentes (alto y bajo). Se encontró que los pacientes de estrato bajo tienen un riesgo diez veces mayor de requerir un procedimiento quirúrgico. Asimismo, registraron una mayor mortalidad en comparación con pacientes de estrato alto (11,3% vs. 4,2%). También se evidenciaron más complicaciones en el grupo de nivel socioeconómico bajo con respecto al alto, como en la falla exocrina (81,1% vs. 31,3%) y el síndrome compartimental (35,8% vs. 4,2%). Conclusión Se encuentra mayor morbimortalidad en los pacientes de bajo nivel socioeconómico en el contexto de esta patología. Este estudio puede guiar a nuevas investigaciones acerca del impacto socioeconómico en los desenlaces de pancreatitis aguda severa.(AU)

ABSTRACT Objetive Acute pancreatitis of biliary origin is a common gastrointestinal pathology, in which timely management still is the most important. The aims of this research is establish the socioeconomic impact in the current management of severe acute pancreatitis of biliary origin comparing two centers of the third level, one of high socioeconomic population and another of low in Bogotá, Colombia. Materials and Methods A retrospective, cross-sectional comparative study was conducted between January 2012 and December 2017, in two hospitals of Bogotá DC. We evaluated their socioeconomic characteristics, gender, time of evolution at the time of consultation, Marshall score, ICU stay, hospital stay, complications, surgical management and mortality. Results 101 patients from two different socioeconomic strata (high and low) were analyzed, where a 10 times higher risk of requiring a surgical procedure in the group of patients with low stratum was found, as well as a higher mortality compared with those of high stratum. (11.3% Vs 4.2%). There were also more complications in the low socioeconomic group with respect to the high, as in the exocrine failure (81.1% vs 31.3%) and the compartment syndrome (35.8% vs 4.2%). Conclusion There is greater morbidity and mortality in patients of low socioeconomic status in the context of this pathology. This study can guide new research that increases the clarity of the socioeconomic impact on the outcomes of severe acute pancreatitis.(AU)

[Socioeconomic impact of the current management of severe biliary acute pancreatitis: comparative study]. / Impacto socioeconómico del manejo actual de la pancreatitis aguda de origen biliar severa: estudio comparativo.

OBJETIVE: Acute pancreatitis of biliary origin is a common gastrointestinal pathology, in which timely management still is the most important. The aims of this research is establish the socioeconomic impact in the current management of severe acute pancreatitis of biliary origin comparing two centers of the third level, one of high socioeconomic population and another of low in Bogotá, Colombia. MATERIALS AND METHODS: A retrospective, cross-sectional comparative study was conducted between January 2012 and December 2017, in two hospitals of Bogotá DC. We evaluated their socioeconomic characteristics, gender, time of evolution at the time of consultation, Marshall score, ICU stay, hospital stay, complications, surgical management and mortality. RESULTS: 101 patients from two different socioeconomic strata (high and low) were analyzed, where a 10 times higher risk of requiring a surgical procedure in the group of patients with low stratum was found, as well as a higher mortality compared with those of high stratum. (11.3% Vs 4.2%). There were also more complications in the low socioeconomic group with respect to the high, as in the exocrine failure (81.1% vs 31.3%) and the compartment syndrome (35.8% vs 4.2%). CONCLUSION: There is greater morbidity and mortality in patients of low socioeconomic status in the context of this pathology. This study can guide new research that increases the clarity of the socioeconomic impact on the outcomes of severe acute pancreatitis.

OBJETIVO: La pancreatitis aguda de origen biliar es una patología gastrointestinal común, en donde el tratamiento oportuno es el pilar más importante a pesar de sus discrepancias. El objetivo del estudio es establecer el impacto socioeconómico en el manejo actual de esta patología, comparando dos hospitales de tercer nivel de estrato socioeconómico alto y bajo de la ciudad de Bogotá, Colombia. MATERIALES Y MÉTODOS: Se realizó un estudio retrospectivo, comparativo de corte transversal entre enero de 2012 y diciembre de 2017, en dos hospitales de Bogotá D. C. Se evaluaron sus características socioeconómicas, género, tiempo de evolución al momento de la consulta, Marshall score, estancia en UCI, estancia hospitalaria, complicaciones, manejo quirúrgico y mortalidad. RESULTADOS: Se analizaron 101 pacientes de dos estratos socioeconómicos diferentes (alto y bajo). Se encontró que los pacientes de estrato bajo tienen un riesgo diez veces mayor de requerir un procedimiento quirúrgico. Asimismo, registraron una mayor mortalidad en comparación con pacientes de estrato alto (11,3% vs. 4,2%). También se evidenciaron más complicaciones en el grupo de nivel socioeconómico bajo con respecto al alto, como en la falla exocrina (81,1% vs. 31,3%) y el síndrome compartimental (35,8% vs. 4,2%). CONCLUSIÓN: Se encuentra mayor morbimortalidad en los pacientes de bajo nivel socioeconómico en el contexto de esta patología. Este estudio puede guiar a nuevas investigaciones acerca del impacto socioeconómico en los desenlaces de pancreatitis aguda severa.

Role of the burden of premature atrial contractions during the blanking period following second-generation cryoballoon ablation in predicting late recurrences of atrial arrhythmias.

PURPOSE: Recent data suggests that high burden of premature atrial complexes after pulmonary vein isolation predicts recurrences of atrial arrhythmias. The present study sought to assess the role of premature atrial complexes burden in predicting atrial arrhythmias recurrences in patients with atrial fibrillation (AF) who have undergone second-generation cryoballoon ablation (CB-Adv). METHODS: Consecutive patients with drug-resistant paroxysmal atrial fibrillation who underwent pulmonary vein isolation using CB-Adv technology as the index procedure were retrospectively included. Twenty-four-hour Holter recordings were performed for every patient. Based on previously published data, a burden of more than 76 premature atrial complexes per day was considered as being high. RESULTS: One hundred and seven patients were included in the analysis. The recurrence rate among the group of patients with more than 76 premature atrial complexes per day was significantly higher compared with the group with a lower burden of premature atrial complexes (47.5 vs 11.9%, respectively; p < 0.001). In the multivariate analysis, the documentation of more than 76 premature atrial complexes per day registered at 1 month and at the end of the blanking period, predicted late recurrence of atrial arrhythmias. CONCLUSIONS: Frequent premature atrial complexes in the early stages after CB-Adv ablation strongly predict late recurrences of atrial arrhythmias.

Single freeze strategy with the second- generation cryballoon for atrial fibrillation: a multicenter international retrospective analysis in a large cohort of patients.

PURPOSE: The second-generation cryoballoon (CB-A, Arctic Front Advance, Medtronic, Minneapolis, MN, USA) has proven to be highly effective in achieving freedom from atrial fibrillation; nonetheless, the ideal number and duration of freezing cycles is still a matter of debate. We investigated the acute success, procedural complications, and clinical outcome of a single freeze strategy using the CB-A in a large, retrospective, international multicenter study. METHODS: Between January 2013 and September 2015, 818 consecutive patients (58 ± 12 years, 68% males) with drug-resistant atrial fibrillation (AF) who underwent a CB-A using a single freeze strategy were taken into consideration for our analysis. RESULTS: Paroxysmal AF was documented in 74.1% of the patients, while 25.9% presented with persistent AF. Additional freezes were needed in a mean 1.4 veins per patient. 0.2% of the patients experienced persistent PNP that was still documented at the last follow-up. After a median follow-up of 14 ± 8 months, taking into consideration a blanking period (BP) of 3 months, 692 patients (84.6%) were free from arrhythmia recurrence. After a single procedure, AF recurrence during BP and persistent AF were identified as predictors of clinical recurrence after BP. CONCLUSIONS: Single freeze CB-A ablation is effective in treating drug-resistant AF and affords freedom from arrhythmia recurrences in 84.6% of patients during a 14-month follow-up. Persistent AF and recurrence during BP are predictors of arrhythmia recurrences.