Late bleeding events in TAVI patients receiving vitamin K antagonists or direct oral anticoagulants.

INTRODUCTION AND OBJECTIVES: The optimal chronic antithrombotic regimen for patients with atrial fibrillation undergoing transcatheter aortic valve implantation (TAVI) remains uncertain. Our aim was to compare the incidence of late bleeding events between patients on direct oral anticoagulants (DOACs) and those on vitamin-K antagonists (VKA). METHODS: This single-center observational study included TAVI patients requiring oral anticoagulation at discharge between 2015 and 2021. The primary endpoint was any clinically significant bleeding event. Secondary endpoints were stroke, heart failure, and all-cause mortality. RESULTS: A total of 702 TAVI procedures were performed, with 297 patients requiring oral anticoagulation at discharge. Among them, 206 (69.4%) received VKA and 91 (30.6%) received DOAC. Baseline clinical, procedural and in-hospital characteristics did not significantly differ between groups, except for better renal function among DOAC patients. The median length of follow-up was 2.8 years. The risk of bleeding events was higher in patients receiving DOACs than in those receiving VKA (HR, 2.27; 95%CI, 1.21-4.26; incidence of 9.7 and 4.2 events per 100 patient-years of follow-up for DOAC and VKA patients, respectively). There were no statistically significant differences in the rates of stroke (HR, 1.28; 95%CI, 0.4-4.3), heart failure hospitalization (HR, 0.92; 95%CI, 0.46-1.86), or all-cause mortality (HR, 1.02; 95%CI, 0.68-1.55). CONCLUSIONS: In older patients undergoing TAVI and receiving anticoagulant therapy for atrial fibrillation, the use of DOAC was associated with a higher risk of late bleeding events than VKA.

Hemodynamic performance of self-expandable transcatheter aortic valve replacement systems during valve deployment.

OBJECTIVES: Little is known about valve hemodynamic performance during the Evolut and Neo deployment course. We aimed to evaluate transvalvular mean and peak-to-peak gradients over several intraprocedural timepoints during TAVR with Evolut PRO+ (Medtronic) and Neo (Boston Scientific) systems. METHODS: This was single-center pilot sub-study from the SavvyWire EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI) trial. Participants received either the Evolut PRO+ or Neo for native valve severe aortic stenosis and the SavvyWire (OpSens Medical) was used for device delivery, pacing, and continuous left ventricular and aortic pressure measurements. For the Evolut, evaluation was done for baseline, two-thirds of valve deployment (still recapturable), 90% of valve deployment (no longer recapturable), and post-deployment hemodynamics. For the Neo, analysis was done at baseline, after the first step (top-crown deployment), and at final status. RESULTS: Nineteen patients were included (Evolut = 15; Neo = 4). There were no statistically significant changes in peak-to-peak gradients (44 mm Hg [IQR:33-69] vs 43 mm Hg [IQR:26-62], P = .41) between baseline and two-thirds of valve deployment in the Evolut patients. There was a significant decrease in mean (40 mm Hg [IQR:32-54] vs 14 mm Hg [IQR:10-18], P less than .001) and peak-to-peak (43 mmHg [IQRS:26-62] vs 9 mm Hg [IQR:8-13], P less than .001) transvalvular gradients between two-thirds and 90% of valve deployment for Evolut. Neo patients exhibited a decrease in transvalvular gradients after top-crown deployment (42.5 mm Hg baseline vs 13 mm Hg). CONCLUSIONS: Transvalvular gradients did not vary between the point of "no-recapture" compared to baseline values in patients receiving the Evolut, whereas a significant reduction in transvalvular gradients was observed when the valve was deployed at 90% and fully deployed. The Neo valve was slightly obstructive after the first step of deployment.

Optimal oversizing in transcatheter aortic valve replacement with the self-expanding Evolut valve system.

OBJECTIVES: Valve oversizing has been associated with reduced paravalvular leaks (PVL) and valve migration risk. However, no optimal cut-off oversizing value has been defined for the Evolut system (Medtronic). The aim of this study was to assess the relationship between the degree of oversizing and moderate-to-severe PVL and determine the optimal oversizing cut-off value. METHODS: We conducted a multicenter study that included 740 consecutive patients with multidetector computed tomography (CT) data. Valve size was selected according to manufacturer recommendations, with oversizing ranging from 10% to 30%. The primary endpoint was moderate-to-severe PVL. RESULTS: The median age was 84 years (79-87 years), with 58.4% women, and a median EuroSCORE II of 4.1% (2.4-7.3%). Moderate-to-severe PVL was observed in 7.0% of the patients. An inverse relationship was found between oversizing and both PVL (11.3%, 8.6%, 5.4%, and 2.7% for quartiles Q1 to Q4; P = .007) and the need for post-dilation (P = .016). The multivariable analysis showed an association between oversizing and PVL (OR: 0.915 for each 1%-increase, P = .002). The optimal oversizing cut-off value to predict PVL was 20%, and PVL was significantly higher in patients with oversizing less than 20% (10.5% vs.4.2%, P less than .001). There were no differences in major clinical events according to the degree of oversizing, and a higher oversizing did not translate into an increased risk of permanent pacemaker (18.4% vs18.3%, P = .976). CONCLUSIONS: In TAVR with the Evolut valve, a higher oversizing was associated with lower rates of moderate-to-severe PVL and a lower need for post-dilation, with no negative impact on procedural and early clinical outcomes. A 20% oversizing threshold could be suggested to reduce PVLs. Further prospective studies are warranted to validate optimal oversizing for this valve system.

Sex-Related Differences in Life Expectancy Compared to General Population after Surgery for Ascending Aortic Aneurysm.

Background/Objectives: Understanding sex-based differences in cardiovascular outcomes is paramount to improving clinical outcomes. Surgery is an aggressive but effective therapy for ascending aortic aneurysm. We sought to determine if being a woman is a risk factor for long-term mortality after this surgery. We compared their life expectancy with a general population of the same age, sex, year, and region. Methods: We compared men and women undergoing AAA surgery at our institution from 2000 to 2019. After balancing the population with propensity score (PS) matching, we compared long-term mortality control with a Cox regression. We determined the RS using the Ederer II method and compared it to a healthy reference population of the same age, sex, and region. Results: From 2000 to 2019, 232 women and 506 men underwent ascending aortic aneurysm surgery. After a mean follow-up of 51.5 ± 34.5 months, sex was not an independent risk factor for long-term mortality in the multivariable analysis [HR: 0.68 (95% CI 0.43-1.07, p = 0.23)]. Matching by baseline characteristics, 196 pairs were analyzed with no differences regarding mortality in the Cox regression [HR: 1.11 (95% CI 0.65-1.9, p = 0.23)]. Men and women who survived the postoperative period presented a relative survival of 100.3% (95% CI 97.4-101%) and 100.3% (95% CI 98.9-101.1%), respectively, similar to the reference population without the disease. Conclusions: For patients undergoing AAA surgery, sex was not an independent predictor of mortality. Men and women who survived the postoperative period presented a similar life expectancy to that of the reference population (people free from the disease of the same age, sex, year, and region).

Clinical impact of complex percutaneous coronary intervention in the pre-TAVR workup.

INTRODUCTION AND OBJECTIVES: In patients undergoing percutaneous coronary intervention (PCI) in the workup pre-transcatheter aortic valve replacement (TAVR), the clinical impact of coronary revascularization complexity remains unknown. This study sought to examine the impact of PCI complexity on clinical outcomes after TAVR in patients undergoing PCI in the preprocedural workup. METHODS: This was a multicenter study including consecutive patients scheduled for TAVR with concomitant significant coronary artery disease. Complex PCI was defined as having at least 1 of the following features: 3 vessels treated, ≥ 3 stents implanted, ≥ 3 lesions treated, bifurcation with 2 stents implanted, total stent length >60mm, or chronic total occlusion. The rates of major adverse cardiac events (MACE), including cardiovascular mortality, myocardial infarction, and coronary revascularization were evaluated. RESULTS: A total of 1550 patients were included, of which 454 (29.3%) underwent complex PCI in the pre-TAVR workup. After a median follow-up period of 2 [1-3] years after TAVR, the incidence of MACE was 9.6 events per 100 patients-years. Complex PCI significantly increased the risk of cardiac death (HR, 1.44; 95%CI, 1.01-2.07), nonperiprocedural myocardial infarction (HR, 1.52; 95%CI, 1.04-2.21), and coronary revascularization (HR, 2.46; 95%CI, 1.44-4.20). In addition, PCI complexity was identified as an independent predictor of MACE after TAVR (HR, 1.31; 95%CI, 1.01-1.71; P=.042). CONCLUSIONS: In TAVR candidates with significant coronary artery disease requiring percutaneous treatment, complex revascularization was associated with a higher risk of MACE. The degree of procedural complexity should be considered a strong determinant of prognosis in the PCI-TAVR population.

IAMCEST en mujeres. Recuperación de la expectativa de vida tras la intervención coronaria percutánea / STEMI in women. Life expectancy recovery after primary percutaneous coronary intervention

Introducción y objetivos: La mortalidad tras un infarto agudo de miocardio con elevación del segmento ST (IAMCEST) sigue siendo alta a pesar de los avances médicos. Las mujeres están poco representadas en los estudios, lo que limita el conocimiento sobre su tratamiento y su pronóstico. Se desconoce si las mujeres tratadas con intervención coronaria percutánea (ICP) primaria recuperan una esperanza de vida similar a una población de referencia. El objetivo del estudio es determinar si las mujeres sometidas a ICP primaria recuperan una supervivencia similar a la población general de iguales edad y región. Métodos: Se incluyeron todos los IAMCEST desde enero de 2014 a octubre de 2021. Se emparejó la muestra con una población de referencia de iguales edad y región, obtenida del Instituto Nacional de Estadística. Se determinaron las supervivencias observada y esperada y el exceso de mortalidad (EM) mediante el método Ederer II. Se repitió el análisis para mujeres de edad ≤ 65 y> 65 años. Resultados: Se reclutó a 2.194 personas; 528 casos eran mujeres (23,9%). Entre las mujeres que sobrevivieron los primeros 30 días, los EM del 1.er, el 5.o y el 7.o año fueron del 1,6% (IC95%, 0,3-4), el 4,7% (IC95%, 0,3-10,1) y el 7,21% (IC95%, 0,5-15,1) respectivamente. Conclusiones: Las mujeres con un IAMCEST tratadas con ICP primaria que sobreviven al evento agudo reducen significativamente su EM y presentan una esperanza de vida similar a la de la población de referencia de iguales edad y región.(AU)

Introduction and objectives: Despite medical advances, mortality after ST-elevation myocardial infarction (STEMI) remains high. Women are often underrepresented in trials and registries, limiting knowledge of their management and prognosis. It is unknown whether life expectancy in women of all ages treated with primary percutaneous coronary intervention (PPCI) is similar to that in a reference population free of the disease. The main objective of this study was to determine whether life expectancy in women undergoing PPCI and surviving the main event returns to a similar level to that in the general population of the same age and region. Methods: We included all patients diagnosed with STEMI from January 2014 to October 2021. We matched women to a reference population of the same age and region from the National Institute of Statistics to determine observed survival, expected survival, and excess mortality (EM) using the Ederer II method. We repeated the analysis in women aged ≤ 65 and> 65 years. Results: A total of 2194 patients were recruited, of whom 528 were women (23.9%). In women surviving the first 30 days, EM at 1, 5 and 7 years was 1.6% (95%CI, 0.3-4), 4.7% (95%CI, 0.3-10.1), and 7.2% (95%CI, 0.5-15.1), respectively. Conclusions: EM was reduced in women with STEMI who were treated with PPCI and who survived the main event. However, life expectancy remained lower than that in a reference population of the same age and region.(AU)

Resultados a corto y medio plazo de la reparación transcatéter de la válvula tricúspide: revisión sistemática y metanálisis de estudios observacionales / Early and mid-term outcomes of transcatheter tricuspid valve repair: systematic review and meta-analysis of observational studies

Introducción y objetivos La insuficiencia tricuspídea (IT) se asocia con un peor pronóstico si no se corrige. Se han publicado recientemente numerosos estudios sobre reparación transcatéter de la válvula tricúspide (RTT) Métodos Se llevó a cabo una revisión sistemática de estudios que publican datos clínicos de pacientes con IT significativa sometidos a RTT. Se evaluaron objetivos clínicos y ecocardiográficos a corto y medio plazo. Las razones de riesgo (RR) y las diferencias de medias (DM) se obtuvieron de la comparación de datos previos y posteriores a la intervención. Se hizo también un análisis de sensibilidad según el abordaje principal (reparación borde a borde frente a anuloplastia) Resultados Se incluyeron 19 estudios (todos observacionales o ensayos de un solo grupo) con un total de 991 pacientes sometidos a RTT sola. Las tasas de mortalidad e ictus a 30 días fueron del 2,8 y el 0,2% respectivamente. El análisis agrupado de efectos aleatorios mostró una reducción significativa de IT (RR=0,33; IC95%, 0,26-0,42; p <0,001), vena contracta (DM, 5,9mm; IC95%, 4-7,9; p <0,001), diámetro telediastólico del ventrículo derecho (DM, 3,5mm; IC95%, 2,5-4,5; p <0,001) y clase funcional de la NYHA 3 o 4 (RR=0,32; IC95%, 0,27-0,37; p <0,001) a los 30 días. Las complicaciones hemorrágicas y la IT residual al menos grave fueron numéricamente superiores en el grupo de anuloplastia percutánea en comparación con el grupo de reparación borde a borde (hemorragias, el 13,3 y el 2,8%; IT residual, el 40,4 y el 27,9%) Conclusiones En los 991 pacientes que formaron parte de la experiencia inicial de RTT, tras la intervención se observó una reducción estadísticamente significativa del grado de IT grave o peor, una mala clase funcional (NYHA 3-4), la anchura de la vena contracta y el diámetro telediastólico del ventrículo derecho. Hasta ahora, el abordaje con reparación borde a borde parece tener un mejor perfil de seguridad (AU)

Introduction and objectives Severe tricuspid regurgitation (TR) is associated with poor prognosis when left untreated, and a growing number of studies on transcatheter tricuspid valve repair (TTVr) have been published over the last few months. Methods We performed a comprehensive systematic review of published literature providing clinical data on TTVr for patients with significant TR. Early and mid-term clinical and echocardiographic outcomes were evaluated. Risk ratios (RR) or mean differences (MD) were obtained when comparing pre- and postprocedural data. A sensitivity analysis was also performed according to the main approach for repair (edge-to-edge vs annuloplasty). Results A total of 19 studies (all observational or single-arm trials) and 991 patients who underwent isolated TTVr were included. Thirty-day mortality and stroke rates were 2.8% and 0.2%, respectively. Pooled random-effects resulted in a significant reduction of ≥ severe TR (RR, 0.33; 95%CI, 0.26-0.42; P<.001), vena contracta width (MD, 5.9mm; 95%CI, 4-7.9; P <.001), right ventricular end-diastolic diameter (MD, 3.5mm; 95%CI, 2.5-4.5; P <.001), and New York Heart Association (NYHA) class III or IV at last follow-up (RR, 0.32; 95%CI, 0.27-0.37; P <.001). Bleeding complications and residual ≥ severe TR were numerically higher in the annuloplasty-like group compared with edge-to-edge repair (13.3% vs 3.8% for bleeding and 40.4% vs 27.9% for residual severe TR). Conclusions Among 991 patients comprising the early experience for several TTVr devices, there was a statistically significant reduction in ≥ severe TR, NYHA class III-IV, vena contracta width and right ventricular end-diastolic diameter after TTVr. Thus far, the edge-to-edge approach seems to be associated with a better safety profile (AU)

Supervivencia de los pacientes ancianos con implante percutáneo de válvula aórtica comparados con la población general / Survival in elderly patients with transcatheter aortic valve implants compared with the general population

INTRODUCCIÓN Y OBJETIVOS: La estenosis aórtica grave sintomática conlleva un pronóstico ominoso. El recambio percutáneo de válvula aórtica ha mostrado que cambia la historia natural de la enfermedad. Sin embargo, se desconoce si los pacientes mayores intervenidos recuperan una supervivencia similar a la de la población general. Nuestro objetivo es conocerlo. MÉTODOS: Se analizó de manera retrospectiva la curva de supervivencia de los pacientes mayores de 75 años intervenidos mediante implante percutáneo de válvula aórtica (TAVI) en nuestro centro y se comparó con la población general de iguales edad, sexo y región geográfica utilizando datos del Instituto Nacional de Estadística. RESULTADOS: Se analizó a 526 pacientes. Una vez superado el periodo posoperatorio, las curvas de supervivencia se igualaron durante la mayor parte del seguimiento. Las probabilidades de sobrevivir para los pacientes TAVI a los 1, 3, 5 y 8 años fueron del 90,58% (intervalo de confianza [IC] del 95%, 87,54-92,91), el 72,51% (IC95%, 67,38-76,97), el 53,23% (IC95%, 46,52-59,48) y el 35,73% (IC95%, 27,72-43,80). En la población de referencia fueron el 91,93, el 75,63, el 59,6 y el 37,47%. CONCLUSIONES: La supervivencia de los pacientes mayores intervenidos mediante TAVI está condicionada por la mortalidad posoperatoria. Los supervivientes al periodo posoperatorio recuperan una supervivencia similar a la de la población general de iguales edad, sexo y territorio

INTRODUCTION AND OBJECTIVES: Severe symptomatic aortic stenosis carries a very poor prognosis. Transcatheter aortic valve replacement has been demonstrated to change the natural history of the disease. However, it is not known whether the probability of survival in older patients receiving this treatment returns to a similar value to that in the general population. Our objective was to determine survival in these patients vs that in the general population. METHODS: We retrospectively analyzed the survival curves of patients older than 75 years who underwent transcatheter aortic valve implantation (TAVI) at our hospital and compared them with those in the general population of the same age, sex, and geographic region by using data from the Spanish National Institute of Statistics. RESULTS: We analyzed 526 patients. Among postoperative survivors, survival curves were similar between the 2 groups during most of the follow-up. In TAVI patients, the probability of survival at 1, 3, 5, and 8 years of follow-up was 90.58% (confidence interval [CI] 95%, 87.54-92.91), 72.51% (95%CI, 67.38-76.97), 53.23% (95%CI, 46.52-59.48), and 35.73% (95%CI, 27.72-43.80). In the reference population, these percentages were 91.93%, 75.63%, 59.6%, and 37.47%. CONCLUSIONS: Long-term survival in elderly patients undergoing TAVI is influenced by postoperative mortality. In patients surviving the postoperative period, the probability of survival returns to a similar value to that in the general population of the same age, sex, and geographical area

Cierre percutáneo del foramen oval permeable en pacientes mayores de 60 años con ictus criptogénico / Transcatheter closure of patent foramen ovale in patients older than 60 years of age with cryptogenic embolism

INTRODUCCIÓN Y OBJETIVOS: Estudios aleatorizados han mostrado la eficacia del cierre percutáneo del foramen oval permeable (FOP) en pacientes de edad ≤ 60 años con ictus criptogénico. El objetivo de este estudio es determinar la seguridad y la eficacia a largo plazo del cierre percutáneo del FOP en pacientes mayores de 60 años con ictus criptogénico. MÉTODOS: De 475 pacientes consecutivos con ictus criptogénico que se sometieron al cierre del FOP, 90 eran mayores de 60 años (media, 66+/-5 años) y se los comparó con los 385 del grupo de edad ≤ 60 años (media, 44+/-10 años). RESULTADOS: Los pacientes mayores de 60 años tuvieron mayor prevalencia de factores de riesgo cardiovascular (FRCV) (hipertensión, dislipemia y diabetes; p <0,01). No hubo diferencias en cuanto a complicaciones periprocedimiento. El seguimiento medio fue de 8 (4-12) años y hubo 17 muertes, todas de causa no cardiovascular (el 7,8% de los mayores de 60 años y el 2,6% de los de edad ≤ 60 años; HR=4,12; IC95%, 1,56-10,89). Tuvieron un ictus recurrente 4 pacientes (el 2,2% de los mayores de 60 años frente al 0,5% de los de edad ≤ 60 años; HR=5,08; IC95%, 0,71-36,2), y un accidente isquémico transitorio (AIT) 12 pacientes (el 3,3 frente al 2,3%; HR=1,71; IC95%, 0,46-6,39). Hubo tendencia a una mayor incidencia de ictus/AIT en los mayores de 60 años (el 5,5 frente al 2,6%; HR=2,62; IC95%, 0,89-7,75; p = 0,081), que no persistió tras ajustar por FRCV (HR=1,97; IC95%, 0,59-6,56; p = 0,269). CONCLUSIONES: El cierre percutáneo del FOP en pacientes mayores de 60 años con ictus criptogénico resultó seguro y se asoció con una baja incidencia de eventos isquémicos a largo plazo. Sin embargo, en los pacientes mayores de 60 años se observó una tendencia a mayor incidencia de ictus/AIT probablemente relacionada con mayor prevalencia de FRCV

INTRODUCTION AND OBJECTIVES: Randomized trials have shown the efficacy of transcatheter closure of patent foramen ovale (PFO) in patients aged ≤ 60 years with cryptogenic embolism. We aimed to assess the long-term safety and efficacy of PFO closure in patients aged> 60 years. METHODS: Of 475 consecutive patients with cryptogenic embolism who underwent PFO closure, 90 older patients aged> 60 years (mean, 66+/-5 years) were compared with 385 younger patients aged ≤ 60 years (mean, 44+/-10 years). RESULTS: Older patients had a higher prevalence of cardiovascular risk factors (CVRF) (hypertension, dyslipidemia, diabetes; P <.01 for all vs younger patients). There were no differences in periprocedural complications between the 2 groups. During a median follow-up of 8 (4-12) years, there were a total of 17 deaths, all from noncardiovascular causes (7.8% and 2.6% in the older and younger patient groups, respectively; HR, 4.12; 95%CI, 1.56-10.89). Four patients had a recurrent stroke (2.2% and 0.5% in the older and younger patient groups, respectively; HR, 5.08; 95%CI, 0.71-36.2), and 12 patients had a transient ischemic attack (TIA) (3.3% and 2.3% in the older and younger patient groups, respectively; HR, 1.71; 95%CI, 0.46-6.39). There was a trend toward a higher rate of the composite of stroke/TIA in older patients (5.5% vs 2.6%; HR, 2.62; 95%CI, 0.89-7.75; P=.081), which did not persist after adjustment for CVRF (HR, 1.97; 95%CI, 0.59-6.56; P=.269). CONCLUSIONS: In older patients with cryptogenic embolism, PFO closure was safe and associated with a low rate of ischemic events at long-term. However, older patients exhibited a tendency toward a higher incidence of recurrent stroke/TIA compared with younger patients, likely related to a higher burden of CVRF