Experience with the ACURATE neo and neo2 transcatheter aortic valves in Spain. The PRECISA (PRospective Evaluation Complementing Investigation with ACURATE devices) registry.

BACKGROUND: Previous studies have documented a high rate of implantation success with the ACURATE neo2 valve, as well as a reduction in paravalvular leak (PVL) compared to its predecessor, the ACURATE neo. However, there are no studies that have reviewed and compared the long-term clinical and hemodynamic outcomes of these patients. AIMS: This study aimed to evaluate the results of the ACURATE neo transcatheter aortic valve in a real-world context, and to compare the results of the outcomes of both generations of this device (ACURATE neo and ACURATE neo2), with a specific focus on procedural success, safety, and long-term effectiveness. METHODS: A prospective study including all consecutive patients treated with the ACURATE neo device in seven hospitals was conducted (Clinical Trials Identification Number: NCT03846557). The primary endpoint consisted of a composite of adverse events, including mortality, aortic insufficiency, and other procedural complications. As the second-generation device (ACURATE neo2) replaced the ACURATE neo during the study period, hemodynamic and clinical results before admission, at 30 days, and at 1 year of follow-up were compared between the two generations. RESULTS: A total of 296 patients underwent transcatheter aortic valve implantation with the ACURATE device, with 178 patients receiving the ACURATE neo and 118 patients receiving the ACURATE neo2. In the overall population, the absence of device success occurred in 14.5%. The primary reason for the absence of device success was the presence of para-valvular regurgitation ≥ 2. There were no instances of coronary occlusions, valve embolization, annulus rupture, or procedural deaths. ACURATE neo2 was associated with a significantly higher device success rate (91.7% vs. 82%, p = 0.04), primarily due to a significantly lower rate of para-valvular regurgitation, which remained significant at 1 year. CONCLUSION: The use of ACURATE neo and neo2 transcatheter aortic valves is associated with satisfactory clinical results and an extremely low rate of complications. The ACURATE neo2 enables a significantly higher device success rate, primarily attributed to a significant reduction in the rate of PVL.

Evolution and Prognostic Significance of Patient-Reported Symptoms After Intervention in Severe Aortic Stenosis.

OBJECTIVE: To describe the evolution of symptoms in patients with symptomatic severe aortic stenosis (sSAS) undergoing valve replacement, the predictors of the persistence of these symptoms, and their prognostic significance. The evolution of symptoms after intervention in sSAS and their association with outcome are unknown. PATIENTS AND METHODS: Data from patients with sSAS who underwent intervention were collected. All-cause mortality and cardiovascular mortality were considered events. The evolution of symptoms and their association with events were studied. RESULTS: In this study, 451 consecutive patients with sSAS and no other valvular or coronary disease who were alive 30 days after intervention were included. Before valve replacement, 133 of the 451 patients (29.5%) had congestive heart failure requiring hospitalization. Of the remaining 318 patients, 287 (90.2%) had dyspnea on effort, 129 (40.6%) had angina, and 59 had syncope (18.6%). Symptoms disappeared after intervention in 192 of the 451 patients (42.6%) and remained in 259 (57.4%): 193 dyspnea, 9 angina, 17 syncope, and 60 admission for heart failure. Syncope on effort persisted in 4 of 33 patients (12.1%) and at rest in 11 of 20 (55.0%; P<.001). Age, body mass index, previous admission for heart failure, and chronic obstructive pulmonary disease were independently related to persistence of symptoms. Over a median follow-up of 56 months in our cohort of 451 patients, 129 deaths were registered (28.6%), 40 of which were cardiovascular (8.9%). Age, chronic obstructive pulmonary disease, chronic kidney disease, atrial fibrillation, heart failure, and persistence of symptoms were independently associated with all-cause mortality. CONCLUSION: Symptoms attributed to SAS remain after intervention in a high proportion of patients, particularly dyspnea on effort and syncope at rest. The persistence of symptoms after intervention identifies patients with poor outcome.

Safety of coronary revascularization deferral based on fractional flow reserve and instantaneous wave-free ratio in patients with chronic kidney disease.

BACKGROUND: The safety of revascularization deferral according to pressure wire examination in patients with chronic kidney disease (CKD) has not been fully established. METHODS: From a retrospective cohort of 439 patients in whom revascularization was deferred after physiological assessment, we examined the incidence of patient-oriented composite endpoint (POCE: all-cause death, myocardial infarction [MI] and unplanned revascularization) in patients with CKD (estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73 m²) and without it. RESULTS: At 4 years of follow-up, the primary endpoint was met by 25.0% of patients with CKD and by 14.4% of patients without CKD (hazard ratio [HR] 1.56, 95% confidence interval [CI] 0.96-2.53, p = 0.071). The incidence of POCE was even higher in patients with an eGFR < 30 mL/min/1.73 m²: 43.8% (HR 3.10, 95% CI 1.08-8.92, p = 0.036). However, no differences were observed in the incidence of MI (4.2% vs. 4.4% in non-CKD), target vessel revascularization (5.8% vs. 5.9%), and target vessel MI (0.8% vs. 4.6%). CONCLUSIONS: Patients with CKD in whom pressure-wire evaluation led to deferral of coronary revascularization develop more POCE in the long term, compared to patients with normal renal function. However, the increase in POCE in patients with CKD was seldom related to deferred vessels, thus suggesting an epiphenomenon of an intrinsically higher cardiovascular risk of CKD patients.

Stent strut thickness and acute vessel injury during percutaneous coronary interventions: an optical coherence tomography randomized clinical trial.

AIMS: Compare the degree of acute vascular injury caused by a polymer-free, thin-strut drug-eluting stent (DES) to that caused by a bioresorbable polymer, thick-strut DES using optical coherence tomography (OCT). METHODS AND RESULTS: Fifty patients requiring nonurgent PCI were randomized to receive either a thin or a thick-strut DES. OCT was performed before and after stent implantation. OCT-based injury score (IS) after implantation was numerically higher within thick-strut stents 0.32 vs. 0.23, but the difference was NS (P = 0.61). Edge dissections were present in 36% of the patients without differences between groups. Tissue prolapse (TP) area was larger with thin-strut stents (2.26 vs. 1.83 mm2, P = 0.04). Stent expansion and symmetry index were similar between the two platforms (85% vs. 94%, P = 0.08; and 0.82 vs. 0.80, P = 0.25). No differences were observed in total malapposition area (1.85 mm2 in thin-strut stents vs. 1.47 mm2, P = 0.48). Regarding the influence of plaque-type, IS tended to be higher (non-significant) with thick strut DES in fibrocalcific plaques. Stent malapposition area was smaller in fibrous plaques, especially with thin strut stents (P = 0.03). CONCLUSION: There was no difference in the extent of OCT-based vessel injury associated with thin and thick-strut DES platforms. TP was larger with the thin strut DES, potentially reflecting a deeper stent embedment in the vessel wall.

Rational and design of the Baseline Interatrial block and Transcatheter aortic valve implantation (BIT) registry.

BACKGROUND: Aortic stenosis (AS) is currently the most frequent heart valve disease. Symptomatic severe AS has a poor prognosis and transcatheter aortic valve implantation (TAVI) is becoming the therapy of choice in these patients. Changes in the conduction tissue after the procedure constitute one of the main limitations of TAVI, with a frequent need for a definitive pacemaker. Interatrial block (IAB) is defined as a prolonged P-wave duration and is related with atrial fibrosis. The presence of IAB could be a marker of conduction tissue abnormalities at other levels. No study has specifically analyzed the role of IAB as a predictor of the need for permanent pacemaker in patients with AS undergoing TAVI. METHODS: The Baseline Interatrial block and Transcatheter aortic valve implantation (BIT) registry will be performed in approximately 3000 patients with severe AS treated with TAVI. A centralized analysis of baseline ECGs will study the presence and type of IAB and other ECG data (rhythm, P-wave duration, PR and QRS intervals/intraventricular conduction disorders). Clinical follow-up will be carried out by local researchers. The primary endpoint will be the requirement of permanent pacemaker during post-TAVI hospitalization. As secondary objectives, the incidence of new onset AF, stroke, or mortality during follow-up will be analyzed. Secondary endpoints will include the incidence of new onset AF, stroke, or mortality during follow-up. CONCLUSION: The BIT registry will study, for the first time, the influence of previous IAB in the need of permanent pacemaker after TAVI: This large registry will also provide information regarding the association of this and other ECG parameters with prognosis.

Reparación percutánea combinada de válvula mitral: cierre de fuga paravalvular e implante de prótesis transcatéter en paciente de alto riesgo con insuficiencia mitral grave / Combined percutaneous mitral valve implantation and paravalvular leak closure in a high-risk patient with severe mitral regurgitation

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Cierre percutáneo de CIV y TAVI transfemoral asociado a la exclusión de la orejuela: potenciales beneficios del intervencionismo estructural combinado / Percutaneous Closure of VSD and TAVI With Left Atrial Appendage Exclusion in a Single Procedure: Potential Benefits of a Combined Structural Interventional Procedure

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[Primary percutaneous angioplasty. An analysis of reperfusion delays, their determining factors and their prognostic implications]. / Angioplastia primaria en nuestro medio. Análisis de los retrasos hasta la reperfusión, sus condicionantes y su implicación pronóstica.

INTRODUCTION AND OBJECTIVES: The optimum treatment for patients with ST-segment elevation acute myocardial infraction (AMI) is primary percutaneous coronary intervention (PCI), provided that the door-to-balloon time is less than 90 min. The aims of this study were to determine actual treatment times in our patients, to investigate the effect of different factors in reducing those times, and to evaluate the impact of any delay on prognosis. METHODS: The study involved patients who underwent primary or rescue PCI at our center between January 2005 and October 2007. Treatment times, clinical and angiographic characteristics, and follow-up findings at 1 and 12 months were recorded prospectively. RESULTS: Overall, 389 PCIs were performed: 361 primary and 28 rescue interventions. The median total duration of ischemia was 235 [interquartile range, 170-335] min. The median door-to-balloon time was 79 [53-104] min. The door-to-balloon time was shorter when the ambulance service was able to notify the on-duty cardiologist, who alerted the interventional cardiology team. The difference was 30 [60-90] min (P< .01). Patients who arrived at the emergency department by their own means had the longest door-to-balloon time (100 min vs. 74 min; P< .01). A door-to-balloon time >120 min was associated with higher mortality at 30 days; multivariate analysis showed a clearly increasing trend. CONCLUSIONS: The door-to-balloon time at our center was in line with current recommendations, with the time being markedly shorter for patients for whom the ambulance service was able to give advanced warning. A shorter time was associated with a trend towards lower 30-day mortality.

Angioplastia primaria en nuestro medio. Análisis de los retrasos hasta la reperfusión, sus condicionantes y su implicación pronóstica / Primary percutaneous angioplasty. An analysis of reperfusion delays, their determining factors and their prognostic implications

Introducción y objetivos. El mejor tratamiento para el IAM con elevación del ST es la ICPP siempre que el tiempo puerta-balón sea < 90 min. Presentamos nuestros tiempos reales y valoramos la influencia de determinados factores en su reducción, y la evolución en relación con el tiempo de demora. Métodos. Hemos recogido de manera prospectiva los tiempos, los datos clínicos y angiográficos y el seguimiento a 1 y 12 meses de los pacientes a los que se realizó una ICPP o de rescate en nuestro centro de enero de 2005 a octubre de 2007. Resultados. Se realizaron 389 angioplastias, 361 primarias y 28 de rescate. La mediana del tiempo de isquemia fue 235 [percentiles 25-75, 170-335] min. La mediana del TPG fue 79 [53-104] min. El TPG fue menor cuando el servicio de transporte urgente avisó al cardiólogo de guardia, quien puso en marcha la alerta de hemodinámica, con una diferencia de 30 [90-60] min (p < 0,01). Los pacientes que llegaron a la urgencia por sus propios medios presentaron el mayor tiempo puerta-guía (100 frente a 74 min; p < 0,01). El tiempo puerta-guía > 120 min se asoció a mayor mortalidad a 30 días y a una clara tendencia a aumentarla en el análisis multivariable. Conclusiones. El tiempo puerta-guía en nuestro medio se ajusta a las recomendaciones vigentes, con una clara reducción cuando el servicio de transporte urgente avisa con antelación. Su reducción se relaciona con una tendencia a una menor mortalidad a 30 días (AU)

Introduction and objectives. The optimum treatment for patients with ST-segment elevation acute myocardial infraction (AMI) is primary percutaneous coronary intervention (PCI), provided that the door-to-balloon time is less than 90 min. The aims of this study were to determine actual treatment times in our patients, to investigate the effect of different factors in reducing those times, and to evaluate the impact of any delay on prognosis. Methods. The study involved patients who underwent primary or rescue PCI at our center between January 2005 and October 2007. Treatment times, clinical and angiographic characteristics, and follow-up findings at 1 and 12 months were recorded prospectively. Results. Overall, 389 PCIs were performed: 361 primary and 28 rescue interventions. The median total duration of ischemia was 235 [interquartile range, 170-335] min. The median door-to-balloon time was 79 [53-104] min. The door-to-balloon time was shorter when the ambulance service was able to notify the on-duty cardiologist, who alerted the interventional cardiology team. The difference was 30 [60-90] min (P<.01). Patients who arrived at the emergency department by their own means had the longest door-to-balloon time (100 min vs. 74 min; P<.01). A door-to-balloon time >120 min was associated with higher mortality at 30 days; multivariate analysis showed a clearly increasing trend. Conclusions. The door-to-balloon time at our center was in line with current recommendations, with the time being markedly shorter for patients for whom the ambulance service was able to give advanced warning. A shorter time was associated with a trend towards lower 30-day mortality (AU)