Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation: 1-Year Follow-Up Outcomes.

BACKGROUND: Several orthotopic transcatheter strategies have been developed to treat severe tricuspid regurgitation (TR); however, many patients are deemed unsuitable. Caval valve implantation with the TricValve system addresses this unmet need. OBJECTIVES: This study sought to determine the impact of TricValve on systemic congestion and quality of life (QOL) at 1 year. METHODS: The TRICUS (Safety and Efficacy of the TricValve® Transcatheter Bicaval Valves System in the Superior and Inferior Vena Cava in Patients With Severe Tricuspid Regurgitation) and TRICUS EURO studies were prospective, nonblinded, nonrandomized, single-arm trials representing the early-in-man experience of the TricValve system in NYHA functional class III or IV severe TR patients, optimally medicated and ineligible for open heart surgery, with significant caval backflow. The primary endpoint was QOL metrics and functional status. The 1-year results of the combined cohort are described here. RESULTS: Forty-four patients were included. Mean age was 76.2 ± 7.5 years, 81.0% were women, and the TRISCORE (risk score model for isolated tricuspid valve surgery) was 5.3 ± 1.3. Clinical improvement at 1 year was achieved in 42 (95.5%) patients, measured by (at least 1 of) an increase in ≥15 points from baseline in 12-item Kansas City Cardiomyopathy Questionnaire score, improvement to NYHA functional class to I or II, or an increase ≥40 m in the 6-minute walk test. There were 3 (6.8%) deaths at 1-year follow-up (1 cardiovascular), and the heart failure rehospitalization rate was 29.5%. Stent fracture, conduction system disturbances, or clinically significant leaflet thrombosis were not detected. Abolished hepatic vein backflow was achieved and persisted in 63.8% of the patients, contributing towards a reduction in congestive symptoms, N-terminal pro-B-type natriuretic peptide levels (P = 0.032), and diuretic treatment. CONCLUSIONS: Caval valve implantation with the TricValve system associated with meaningful 1-year clinical improvements in terms of QOL along with relatively low mortality rates. (TRICUS Study - Safety and Efficacy of the TricValve® Device; NCT03723239).

Clinical outcomes of TAVI with the Myval balloon-expandable valve for non-calcified aortic regurgitation.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) in non-calcified aortic regurgitation (NCAR) is an off-label procedure. The balloon-expandable Myval includes extra-large sizes (30.5 mm and 32 mm) of interest in this setting. AIMS: We aimed to evaluate the safety and feasibility of Myval in NCAR. METHODS: This was an international, multicentre, observational study that enrolled all consecutive patients with symptomatic severe NCAR undergoing TAVR with the Myval device. The images were centrally analysed. RESULTS: A total of 113 patients were recruited, 64.6% were men, the mean age was 78.4±7.5 years, and the Society of Thoracic Surgeons score was 2.7±1.7%. Aortic root dilatation was present in 59.3% of patients, 7.1% were bicuspid, and the mean annular area was 638.6±106.0 mm2. The annular area was beyond the recommended range for extra-large sizes in 2.6% of cases, and additional volume was added in 92% (median 4 cc, up to 9 cc). The extra-large sizes were used in 95 patients (84.1%), and the mean oversizing was 17.9±11.0%. The technical success rate was 94.7%; the rate of residual ≥moderate aortic regurgitation was 8.9%, and the pacemaker rate was 22.2%. There were no cases of annular rupture, cardiac tamponade, or aortic dissection, but in 4 patients (3.5%) valve embolisation occurred (1 antegrade and 3 ventricular), all in cases with a tapered left ventricle outflow tract (p=0.007). Thirty-day and 1-year mortality were 5.3% and 9.7%, respectively. Technical success was associated with better survival (97.1% vs 72.7%; p=0.012), and valve embolisation was the main determinant of mortality (p=0.047). CONCLUSIONS: Myval is a feasible and safe option for selected non-operable patients with NCAR and demonstrated good midterm outcomes and lack of impact of oversizing on device durability.

Tratamiento intervencionista de las complicaciones mecánicas en el infarto agudo de miocardio / Interventional management of mechanical complications in acute myocardial infarction

Las complicaciones mecánicas posteriores a un infarto agudo de miocardio no son comunes, pero tienen consecuencias dramáticas y potencialmente letales. El ventrículo izquierdo se ve afectado con mayor frecuencia y las complicaciones se clasifican, según su inicio después del evento primario, en tempranas (de días a semanas después) y tardías (de semanas hasta años). A pesar de que la incidencia de estas complicaciones se ha reducido en la era de la angioplastia primaria —allá donde está disponible—, la mortalidad sigue siendo significativa y, aunque estas complicaciones se consideran poco frecuentes, suponen una emergencia y son una importante causa de mortalidad a corto plazo. Los dispositivos de asistencia circulatoria mecánica, en especial implantados de forma mínimamente invasiva y sin necesidad de toracotomía, han mejorado el pronóstico de estos pacientes al facilitar su estabilidad hasta que se pueda aplicar el tratamiento definitivo. Por otro lado, la creciente experiencia en intervenciones percutáneas para el tratamiento de la rotura del septo interauricular y la insuficiencia mitral aguda se ha asociado con una aparente mejora en sus resultados que aún precisa de la obtención de evidencia prospectiva (AU)

Mechanical complications following a myocardial infarction are uncommon, but with dramatic consequences and high mortality. The left ventricle is the most often affected cardiac chamber and complications can be classified according to the timing in early (from days to first weeks) or late complications (from weeks to years). Despite the decrease in the incidence of these complications thank to primary percutaneous coronary intervention programs —wherever this option is available—, the mortality is still significant and these infrequent complications are an emergent scenario and one of the most important causes of mortality at short term in patients with myocardial infarction. Mechanical circulatory support devices, especially if minimally invasive implantation is used avoiding thoracotomy, have improved the prognosis of these patients by providing stability until definitive treatment can be applied. On the other hand, the growing experience in transcatheter interventions for the treatment of ventricular septal rupture or acute mitral regurgitation has been associated to an improvement in their results, even though prospective clinical evidence is still missing (AU)

Latest-iteration balloon- and self-expandable transcatheter valves for severe bicuspid aortic stenosis: the TRITON study.

INTRODUCTION AND OBJECTIVES: No comparisons have been published yet regarding the newest iteration of balloon- and self-expandable transcatheter heart valves for the treatment of bicuspid aortic valve (BAV) stenosis. METHODS: Multicenter registry of consecutive patients with severe BAV stenosis treated with balloon-expandable transcatheter heart valves (Myval and SAPIEN 3 Ultra, S3U) or self-expanding Evolut PRO+(EP+). TriMatch analysis was carried out to minimize the impact of baseline differences. The primary endpoint of the study was 30-day device success, and the secondary endpoints were the composite and individual components of early safety at 30 days. RESULTS: A total of 360 patients (age 76.6±7.6 years, 71.9% males) were included: 122 Myval (33.9%), 129 S3U (35.8%), and 109 EP+(30.3%). The mean STS score was 3.6±1.9%. There were no cases of coronary artery occlusion, annulus rupture, aortic dissection, or procedural death. The primary endpoint of device success at 30 days was significantly higher in the Myval group (Myval: 100%; S3U: 87.5%; and EP+: 81.3%), mainly due to higher residual aortic gradients with S3U and greater≥moderate aortic regurgitation (AR) with EP+. No significant differences were found in the unadjusted rate of pacemaker implantation. CONCLUSIONS: In patients with BAV stenosis deemed unsuitable for surgery, Myval, S3U and EP+showed similar safety but balloon-expandable Myval had better gradients than S3U, and both balloon-expandable devices had lower residual AR than EP+, suggesting that, taking into consideration the patient-specific risks, any of these devices can be selected with optimal outcomes.

Interventional management of mechanical complications in acute myocardial infarction.

Mechanical complications following a myocardial infarction are uncommon, but with dramatic consequences and high mortality. The left ventricle is the most often affected cardiac chamber and complications can be classified according to the timing in early (from days to first weeks) or late complications (from weeks to years). Despite the decrease in the incidence of these complications thank to primary percutaneous coronary intervention programs -wherever this option is available-, the mortality is still significant and these infrequent complications are an emergent scenario and one of the most important causes of mortality at short term in patients with myocardial infarction. Mechanical circulatory support devices, especially if minimally invasive implantation is used avoiding thoracotomy, have improved the prognosis of these patients by providing stability until definitive treatment can be applied. On the other hand, the growing experience in transcatheter interventions for the treatment of ventricular septal rupture or acute mitral regurgitation has been associated to an improvement in their results, even though prospective clinical evidence is still missing.

Factibilidad del alineamiento comisural y coronario precisos con TAVI balón-expandible / Feasibility of precise commissural and coronary alignment with balloon-expandable TAVI

Introducción y objetivos: Nuestro objetivo fue describir la factibilidad y resultados preliminares de una estrategia de alineamiento comisural preciso (ACP) con implante percutáneo de válvula aórtica balón-expandible. Métodos: Se analizó la relación entre las comisuras nativas y las neocomisuras en 10 pacientes consecutivos con estenosis aórtica grave trivalva y sintomática tras orientar el implante de TAVI basándose en la tomografía computarizada (TC) a través de un programa de análisis específicamente desarrollado. El ACP se predijo en base a modelos in silico que permitieron estimar cuantos grados había que girar la prótesis en el momento del crimpado. El grado de ACP y de solapamiento con los ostium coronarios se midió mediante TC al mes. Se recogieron gradientes transvalvulares y fuga perivalvular. Resultados: El mal alineamiento medio fue de 16,7±8°. Cuatro pacientes presentaron mal alineamiento ligero, pero ninguno moderado o grave. El análisis in silico predijo la posición final de las neocomisuras con un coeficiente de correlación de 0,983 (IC95%, 0,966-0,992), p <0,001. Se produjo solapamiento coronario severo con el ostium de la coronaria derecha en 3 casos en relación con excentricidad de su origen, pero en ningún caso con el ostium coronario izquierdo. El gradiente transaórtico medio fue de 6,1±3,3mmHg y no hubo casos de fuga perivalvular moderada o grave. Conclusiones: Es posible calcular una rotación paciente-específica de la prótesis balón-expandible en el momento del crimpado basándose en la TC preprocedimiento. De este modo, se logró evitar el mal alineamiento moderado o grave de las neo-comisuras y el solapamiento con el ostium coronario izquierdo en todos los casos.(AU)

Introduction and objectives: We aimed to describe the feasibility and preliminary outcomes of commissural alignment (CA) for the balloon-expandable transcatheter heart valve. Methods: The relationship among native commissures and transcatheter aortic valve implantation neocommissures was analyzed in 10 consecutive patients with tricuspid severe aortic stenosis undergoing transcatheter aortic valve implantation after guided implantation based on computed tomography analysis with a self-developed software. CA was predicted by in silico bio-modelling in the 10 patients and the calculated rotation was applied during crimping. Degrees of CA and coronary overlap (CO) were measured through 1-month follow up computed tomography. Transvalvular residual gradients and the rate of paravalvular leak were also analyzed. Results: Mean commissural misalignment was 16.7±8°. Four patients showed mild misalignment but none of them showed a moderate or severe degree of misalignment. The in silico model accurately predicted the final in vivo position with a correlation coefficient of 0.983 (95%CI, 0.966-0.992), P <.001. Severe CO with right coronary ostium occurred in 3 patients likely due to ostial eccentricity, and CO was not present with the left coronary artery in any of the patients. Mean transaortic gradient was 6.1±3.3mmHg and there were no moderate-severe paravalvular leaks. Conclusions: Patient-specific rotation during valve crimping based on preprocedural computed tomography is feasible with balloon-expandable devices and is associated with the absence of moderate or severe commissural misalignment and left main CO.(AU)

Feasibility of precise commissural and coronary alignment with balloon-expandable TAVI.

INTRODUCTION AND OBJECTIVES: We aimed to describe the feasibility and preliminary outcomes of commissural alignment (CA) for the balloon-expandable transcatheter heart valve. METHODS: The relationship among native commissures and transcatheter aortic valve implantation neocommissures was analyzed in 10 consecutive patients with tricuspid severe aortic stenosis undergoing transcatheter aortic valve implantation after guided implantation based on computed tomography analysis with a self-developed software. CA was predicted by in silico bio-modelling in the 10 patients and the calculated rotation was applied during crimping. Degrees of CA and coronary overlap (CO) were measured through 1-month follow up computed tomography. Transvalvular residual gradients and the rate of paravalvular leak were also analyzed. RESULTS: Mean commissural misalignment was 16.7±8°. Four patients showed mild misalignment but none of them showed a moderate or severe degree of misalignment. The in silico model accurately predicted the final in vivo position with a correlation coefficient of 0.983 (95%CI, 0.966-0.992), P <.001. Severe CO with right coronary ostium occurred in 3 patients likely due to ostial eccentricity, and CO was not present with the left coronary artery in any of the patients. Mean transaortic gradient was 6.1±3.3mmHg and there were no moderate-severe paravalvular leaks. CONCLUSIONS: Patient-specific rotation during valve crimping based on preprocedural computed tomography is feasible with balloon-expandable devices and is associated with the absence of moderate or severe commissural misalignment and left main CO.

Validation of Quantitative Flow Ratio-Derived Virtual Angioplasty with Post-Angioplasty Fractional Flow Reserve-The QIMERA-I Study.

Background: Quantitative flow ratio (QFR) virtual angioplasty with pre-PCI residual QFR showed better results compared with an angiographic approach to assess post-PCI functional results. However, correlation with pre-PCI residual QFR and post-PCI fractional flow reserve (FFR) is lacking. Methods: A multicenter prospective study including consecutive patients with angiographically 50-90% coronary lesions and positive QFR results. All patients were evaluated with QFR, hyperemic and non-hyperemic pressure ratios (NHPR) before and after the index PCI. Pre-PCI residual QFR (virtual angioplasty) was calculated and compared with post-PCI fractional flow reserve (FFR), QFR and NHPR. Results: A total of 84 patients with 92 treated coronary lesions were included, with a mean age of 65.5 ± 10.9 years and 59% of single vessel lesions being the left anterior descending artery in 69%. The mean vessel diameter was 2.82 ± 0.41 mm. Procedural success was achieved in all cases, with a mean number of implanted stents of 1.17 ± 0.46. The baseline QFR value was 0.69 ± 0.12 and baseline FFR and NHPR were 0.73 ± 0.08 and 0.82 ± 0.11, respectively. Mean post-PCI FFR increased to 0.87 ± 0.05 whereas residual QFR had been estimated as 0.95 ± 0.05, showing poor correlation with post-PCI FFR (0.163; 95% CI:0.078-0.386) and low diagnostic accuracy (30.9%, 95% CI:20-43%). Conclusions: In this analysis, the results of QFR-based virtual angioplasty did not seem to accurately correlate with post-PCI FFR.

Transcatheter Mitral Valve-in-Valve Implantation with the Balloon-Expandable Myval Device.

Background: The vast majority of transcatheter valve-in-valve (ViV) mitral procedures have been reported with the SAPIEN family. We aimed to report the preliminary experience with the Myval balloon-expandable device in this setting. Methods: Multicenter retrospective study of high-risk surgical patients with mitral bioprosthesis degeneration undergoing transcatheter ViV implantation with Myval device. Results: A total of 11 patients from five institutions were gathered between 2019 and 2022 (age 68 ± 7.8, 63% women). The peak and mean transvalvular gradients were 27 ± 5 mmHg and 14.7 ± 2.3 mmHg, respectively, and the predicted neo-left ventricular outflow tract (neo-LVOT) area was 183.4 ± 56 mm2 (range: 171 to 221 mm2). The procedures were performed via transfemoral access in all cases (through echocardiography-guided transeptal puncture (81.8% transesophageal, 11.2% intracardiac)). Technical success was achieved in all cases, with no significant residual mitral stenosis in any of them (peak 7.2 ± 2.7 and mean gradient 3.4 ± 1.7 mmHg) and no complications during the procedure. There were no data of LVOT obstruction, migration, or paravalvular leak in any case. Mean hospital stay was 3 days, with one major vascular complication and no stroke. At 6-month follow-up, there was one case with suboptimal anticoagulation presenting an increase in the transmitral gradients (mean 15 mmHg) that normalized after optimization of the anticoagulation, but no other relevant events. Conclusions: Transseptal ViV mitral implantation with the balloon-expandable Myval device was feasible and safe avoiding redo surgery in high-risk patients with bioprosthesis degeneration.

Efecto en el control glucémico y modificación del tratamiento en pacientes sometidos a cirugía bariátrica / Effect on glycemic control and modification of treatment in patients submitted to bariatric surgery

Resumen: La obesidad es el factor de riesgo ambiental más importante de diabetes mellitus tipo 2 y puede encontrarse hasta en 90% de los pacientes. La cirugía bariátrica, también conocida como cirugía metabólica, es cada vez más reconocida como una de las intervenciones más eficaces contra la obesidad y comorbilidades, ayudando a los pacientes a lograr la pérdida de peso sostenible y a mejorar su salud en general. Este artículo revisa los diferentes tipos de cirugía bariátrica, así como su efecto en el control glucémico y en la remisión de la diabetes mellitus 2.

Abstract: Obesity is the most important environmental risk factor of diabetes mellitus type 2 and may be found in 90% of patients. Bariatric surgery, also known as metabolic surgery, is each more recognized as one of the most efficient interventions against obesity and comorbidities, helping patients to reach the sustainable weight loss and to improve their general health. This article reviews the different types of bariatric surgery, as well as its impact on glycemic control and on the remission of diabetes mellitus type 2.