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 for transcatheter aortic valve replacement (TAVR), the clinical impact of coronary revascularization complexity remains largely 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 > 60 mm, 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 cardiovascular 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, 1.44; 95%CI, 1.09-1.83; P = .009). 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.

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.

Self-expanding TAVI using the cusp overlap technique versus the traditional technique: electrocardiogram changes and 1-year cardiovascular outcomes.

INTRODUCTION AND OBJECTIVES: Transcatheter aortic valve implantation (TAVI) using the cusp overlap technique (COT) has shown a lower pacemaker implantation rate at 30 days. The objective of this study was to compare electrocardiogram changes and clinical outcomes between COT and the traditional technique (TT) at 1 year of follow-up. METHODS: Observational, retrospective, nonrandomized study of consecutive patients undergoing TAVI between January 2015 and January 2021. Patients were matched using a propensity score and the TT was compared with COT. The primary endpoints were electrocardiogram changes and a combined endpoint including pacemaker implantation, hospitalization, or cardiovascular death at 1 year. RESULTS: We included 254 patients. After propensity score matching, 184 patients (92 per group) remained. There were no statistically significant differences in baseline characteristics. At 1 year, COT patients showed a significant reduction in new onset left bundle branch block (49% vs 27%, P=.002) and less P wave (13.1±21.0 msec vs 5.47±12.5 msec; P=.003) and QRS prolongation (29.77±27.0 msec vs 16.38±25.4 msec, P <.001). COT was associated with a significant reduction in the occurrence of the primary endpoint (SHR, 0.39 [IC95%, 0.21-0.76]; P=.005). CONCLUSIONS: At 1 year of follow-up, COT reduced the incidence of new onset left bundle branch block and diminished QRS and P wave widening compared with the TT. COT was also associated with a statistically significant reduction in the occurrence of the combined primary cardiovascular endpoint.

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)

Safety and Efficacy of TAVR With a Pressure Sensor and Pacing Guidewire: SAFE-TAVI Trial.

BACKGROUND: The SavvyWire (OpSens Inc) is a 0.035-inch preshaped guidewire with dedicated pacing properties and a distal pressure sensor allowing for continuous hemodynamic pressure monitoring. OBJECTIVES: This study sought to determine the efficacy and safety of the guidewire during transcatheter aortic valve replacement (TAVR) procedures. METHODS: This prospective, multicenter clinical study included patients with severe aortic stenosis undergoing TAVR in 8 European centers. The primary efficacy endpoint was defined as effective left ventricular rapid pacing runs with the guidewire translating into a significant systemic pressure drop (below 60 mm Hg). The safety outcome included the absence of major procedural complications related to the guidewire. RESULTS: A total of 121 patients (mean age: 82.2 ± 5.9 years, 50% women) were included in the study, and 119 (98.3%) patients were finally treated with the study device. A balloon-expandable valve was implanted in 45 (37.8%) patients. Predilatation and postdilatation were performed in 89 (74.8%) and 14 (11.8%) patients, respectively. The primary efficacy endpoint was achieved in 116 (98.3%) patients, and the mean aortic systolic arterial pressure achieved during rapid pacing was 46.6 ± 11.3 mm Hg. Hemodynamic assessment with the use of the OptoMonitor 3 (OpSens Inc) without additional catheter exchange was achieved in 117 (99.2%) patients. The safety endpoint was achieved in 117 (99.2%) patients. No procedural mortality, stroke, or ventricular perforation was reported. CONCLUSIONS: The use of the guidewire during TAVR procedures appeared to be efficacious and safe. This device could help minimize interventions during the procedure and improve the clinical decision making after transcatheter heart valve deployment. (SavvyWire Efficacy and Safety in Transcatheter Aortic Valve Implantation Procedures [SAFE-TAVI]; NCT05492383).

Sex Differences in Patients With Cryptogenic Cerebrovascular Events Undergoing Transcatheter Closure of Patent Foramen Ovale.

Background Scarce data exist on sex differences in patients with cryptogenic cerebrovascular events undergoing patent foramen ovale (PFO) closure. This study aimed to determine the sex differences in clinical profile, procedural characteristics, and long-term outcomes of patients with cryptogenic cerebrovascular events undergoing PFO closure. Methods and Results A retrospective cohort was used, including 1076 consecutive patients undergoing PFO closure because of a cryptogenic cerebrovascular event. Patients were divided into 2 groups: 469 (43.6%) women and 607 (56.4%) men. The median follow-up was 3 years (interquartile range, 2-8 years). Women were younger (46±13 versus 50±12 years; P<0.01) and had a higher risk of paradoxical embolism score (6.9±1.7 versus 6.6±1.6; P<0.01). Procedural characteristics and postprocedural antithrombotic therapy were similar. At follow-up, there were no differences in atrial fibrillation (women versus men: 0.47 versus 0.97 per 100 patient-years; incidence rate ratio [IRR], 0.55 [95% CI, 0.27-1.11]; P=0.095; adjusted P=0.901), stroke (0.17 versus 0.07 per 100 patient-years; IRR, 2.58 [95% CI, 0.47-14.1]; P=0.274; adjusted P=0.201), or transient ischemic attack (0.43 versus 0.18 per 100 patient-years; IRR, 2.58 [95% CI, 0.88-7.54]; P=0.084; adjusted P=0.121); nevertheless, women exhibited a higher incidence of combined ischemic cerebrovascular events (0.61 versus 0.26 per 100 patient-years; IRR, 2.58 [95% CI, 1.04-6.39]; P=0.041; adjusted P=0.028) and bleeding events (1.04 versus 0.45 per 100 patient-years; IRR, 2.82 [95% CI, 1.41-5.65]; P=0.003; adjusted P=0.004). Conclusions Compared with men, women with cryptogenic cerebrovascular events undergoing PFO closure were younger and had a higher risk of paradoxical embolism score. After a median follow-up of 3 years, there were no differences in stroke events, but women exhibited a higher rate of combined (stroke and transient ischemic attack) cerebrovascular events and bleeding complications. Additional studies are warranted to clarify sex-related outcomes after PFO closure further.

Late Bleeding Events in Patients Undergoing Percutaneous Coronary Intervention in the Workup Pre-TAVR.

BACKGROUND: In patients undergoing percutaneous coronary intervention (PCI) in the work-up pre-transcatheter aortic valve replacement (TAVR), the incidence and clinical impact of late bleeding events (LBEs) remain largely unknown. OBJECTIVES: This study sought to determine the incidence, clinical characteristics, associated factors, and outcomes of LBEs in patients undergoing PCI in the work-up pre-TAVR. METHODS: This was a multicenter study including 1,457 consecutive patients (mean age 81 ± 7 years; 41.5% women) who underwent TAVR and survived beyond 30 days. LBEs (>30 days post-TAVR) were defined according to the Valve Academic Research Consortium-2 criteria. RESULTS: LBEs occurred in 116 (7.9%) patients after a median follow-up of 23 (IQR: 12-40) months. Late bleeding was minor, major, and life-threatening or disabling in 21 (18.1%), 63 (54.3%), and 32 (27.6%) patients, respectively. Periprocedural (<30 days post-TAVR) major bleeding and the combination of antiplatelet and anticoagulation therapy at discharge were independent factors associated with LBEs (P ≤ 0.02 for all). LBEs conveyed an increased mortality risk at 4-year follow-up compared with no bleeding (43.9% vs 36.0; P = 0.034). Also, LBE was identified as an independent predictor of all-cause mortality after TAVR (HR: 1.39; 95% CI: 1.05-1.83; P = 0.020). CONCLUSIONS: In TAVR candidates with concomitant significant coronary artery disease requiring percutaneous treatment, LBEs after TAVR were frequent and associated with increased mortality. Combining antiplatelet and anticoagulation regimens and the occurrence of periprocedural bleeding determined an increased risk of LBEs. Preventive strategies should be pursued for preventing late bleeding after TAVR, and further studies are needed to provide more solid evidence on the most safe and effective antithrombotic regimen post-TAVR in this challenging group of patients.

Percutaneous Transcatheter Edge-to-Edge Mitral Valve Repair With MitraClip System in the Era of G4.

The use of transcatheter edge-to-edge mitral valve repair (TEER) in symptomatic patients with severe mitral regurgitation (MR) has dramatically increased over the last few years. Current guidelines consider TEER as a reasonable option in symptomatic patients with primary or chronic secondary severe MR with high or prohibitive surgical risk and favorable anatomy. However, several anatomical and morphological mitral features have restricted the use of this mini-invasive technique in its early experience. The latest fourth generation (G4) of the MitraClip system has been recently introduced and includes the possibility of independent leaflet grasping and 4 different sizes. This technical update offers the possibility of selecting and combining multiple devices for complex mitral valve anatomies and challenging procedures, which helps expand the applications of TEER. The present review describes the potential advantages and the help of the MitraClip G4 devices to overcome various anatomic and morphologic issues in challenging cases with complex primary and secondary MR procedures.

Current status of transcatheter mitral valve replacement: systematic review and meta-analysis.

Introduction: Mitral Regurgitation (MR) has a strong impact on quality of life and on mid-term survival. Transcatheter mitral valve replacement (TMVR) is rapidly expanding and a growing number of studies have been published recently. Methods: A systematic review of studies reporting on clinical data for patients with symptomatic severe MR undergoing TMVR was performed. Early- and mid-term outcomes (clinical and echocardiographic) were evaluated. Overall weighted means and rates were calculated. Risk ratios or mean differences were calculated for pre- and post-procedural comparisons. Results: A total of 12 studies and 347 patients who underwent TMVR with devices clinically available or under clinical evaluation were included. Thirty-day mortality, stroke and major bleeding rates were 8.4%, 2.6%, and 15.6%, respectively. Pooled random-effects demonstrated a significant reduction of ≥ grade 3+ MR (RR: 0.05; 95% CI: 0.02-0.11; p < 0.001) and in the rates of patients in NYHA class 3-4 after the intervention (RR: 0.27; 95% CI: 0.22-0.34; p < 0.001). Additionally, the pooled fixed-effect mean difference for quality of life based on the KCCQ score yielded an improvement in 12.9 points (95% CI:7.4-18.4, p < 0.001), and exercise capacity improved by a pooled fixed-effect mean difference of 56.8 meters in the 6-minute walk test (95% CI 32.2-81.3, p < 0.001). Conclusions: Among 12 studies and 347 patients comprising the updated evidence with current TMVR systems there was a statistically significant reduction in ≥ grade 3+ MR and in the number of patients exhibiting poor functional class (NYHA 3 or 4) after the intervention. Overall rate of major bleeding was the main shortcoming of this technique.

STEMI in women. Life expectancy recovery after primary percutaneous coronary intervention.

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.

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)

Leaving obstacles aside: Antegrade paravalvular leakage closure after transcatheter aortic valve replacement.

Paravalvular leakage (PVL) is yet a potential and serious complication after transcatheter aortic valve replacement. Percutaneous PVL closure may be the treatment of choice upon failure of balloon postdilation in patients with excessive surgical risk. If the retrograde approach fails, an antegrade strategy might provide the solution.

Anatomical Changes after Transcatheter Edge-to-Edge Repair in Functional MR According to MitraClip Generation.

BACKGROUND: The use of mitral transcatheter edge-to-edge repair (TEER) is rapidly increasing. Anatomical changes have been described after TEER with the MitraClip system in patients with functional mitral regurgitation (MR), although no study has yet evaluated such anatomical impacts in patients treated with the G4 MitraClip generation. METHODS: This research constituted a prospective, single-center, observational study including consecutive patients with functional MR. Mitral three-dimensional images were obtained transesophageally with echocardiography before and immediately after TEER. Patients receiving the late-generation (G4) system were compared to those receiving early-generation systems. RESULTS: A total of 116 functional MR patients were evaluated, and 40 (34.5%) and 76 (65.5%) received a late-generation (G4) or early-generation device system, respectively. The baseline clinical and echocardiographic features were well-balanced between the groups. Overall, there was a significant reduction in mitral annular size after the intervention, and greater reductions in the anteroposterior diameter (4 mm vs. 3.54 mm, p = 0.03), annular perimeter (11.07 mm vs. 5.29 mm for 3D-perimeter, p = 0.001), and annular area (1.29 cm2 vs. 1.03 cm2, p = 0.002) were found for patients receiving the late G4 device generation compared to the early-generation systems. CONCLUSIONS: In patients with functional MR, we observed significant changes in mitral valve anatomy with a reduction in anteroposterior diameter, valve perimeter, and area. In our cohort, the extent of those changes was greater with the use of the new-generation G4 MitraClip system compared to prior device generations.

Transcatheter Patent Foramen Ovale Closure in Patients With Transient Ischemic Attack.

Limited data exist on patients with a transient ischemic attack (TIA) who underwent patent foramen ovale (PFO) closure. The objectives of this study were to determine the clinical and procedural characteristics and long-term outcomes of patients with TIA who underwent transcatheter PFO closure. This was a multicenter study including 1,012 consecutive patients who underwent PFO closure after a cerebrovascular event. Patients were divided into 2 groups according to their index event leading to PFO closure: TIA (n = 183 [18%]), and stroke (n = 829 [82%]). The median follow-up was 3 (2 to 8) years (complete in 98% of patients). There were no significant differences between patients with TIA and stroke, except for a lower Risk of Paradoxical Embolism score in the TIA group (6.1 vs 6.9 in the stroke group, p <0.001). PFO closure was successful in all patients with a low rate of complications (<1%) in both groups. There were no differences in the incidence of neurologic events during long-term follow-up. There was 1 stroke event in the TIA group and 6 in the stroke group (0.08 vs 0.17 per 100 patients-years, p = 0.584). There were 2 TIA events in the TIA group and 10 in the stroke group (0.17 vs 0.28 per 100 patients-years, p = 0.557). In conclusion, our study showed that patients with TIA who underwent PFO closure have similar clinical characteristics as patients with stroke including a high Risk of Paradoxical Embolism score. Furthermore, these results suggest that PFO closure procedural results and long-term clinical outcomes are similar to their stroke counterparts, with a very low incidence of recurrent neurologic events. Further prospective randomized clinical trials are needed on this population.