Impact of renin-angiotensin system inhibitors on clinical outcomes and ventricular remodelling after transcatheter aortic valve implantation: rationale and design of the RASTAVI randomised multicentre study.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) as a treatment in severe aortic stenosis (AS) is an excellent alternative to conventional surgical replacement. However, long-term outcomes are not benign. Renin-angiotensin system (RAS) blockade has shown benefit in terms of adverse remodelling in severe AS and after surgical replacement. METHODS AND ANALYSIS: The RAS blockade after TAVI (RASTAVI) trial aims to detect if there is a benefit in clinical outcomes and ventricular remodelling with this therapeutic strategy following the TAVI procedure. The study has been designed as a randomised 1:1 open-label study that will be undertaken in 8 centres including 336 TAVI recipients. All patients will receive the standard treatment. The active treatment group will receive ramipril as well. Randomisation will be done before discharge, after signing informed consent. All patients will be followed up for 3 years. A cardiac magnetic resonance will be performed initially and at 1 year to assess ventricular remodelling, defined as ventricular dimensions, ejection fraction, ventricular mass and fibrosis. Recorded events will include cardiac death, admission due to heart failure and stroke. The RASTAVI Study will improve the management of patients after TAVI and may help to increase their quality of life, reduce readmissions and improve long-term survival in this scenario. ETHICS AND DISSEMINATION: All authors and local ethics committees have approved the study design. All patients will provide informed consent. Results will be published irrespective of whether the findings are positive or negative. TRIAL REGISTRATION NUMBER: NCT03201185.

Terapias percutáneas en el tratamiento de la insuficiencia cardiaca aguda y crónica: presente y futuro / Current and future percutaneous strategies for the treatment of acute and chronic heart failure

La prevalencia de la insuficiencia cardiaca (IC) aumenta paralelamente al envejecimiento poblacional y la mayor supervivencia de los pacientes con infarto de miocardio. Recientemente se han desarrollado nuevas terapias percutáneas con el objetivo de complementar los tratamientos actuales de la IC aguda/descompensada y crónica minimizando los riesgos. En la IC aguda, el fracaso del tratamiento médico ya no puede ser el final de la estrategia terapeútica para el shock cardiogénico, dado el éxito de los dispositivos de soporte circulatorio mecánico. A pesar de que la evidencia en esta área es difícil de generar, el pronóstico de la IC aguda está cambiando radicalmente gracias a la investigación en red sobre dispositivos de flujo pulsátil (balón de contrapulsación intraaórtico), continuo axial (Impella) o continuo centrífugo (TandemHeart; HeartMate PHP) junto con el implante percutáneo de oxigenador extracorpóreo de membrana. Las nuevas terapias percutáneas en la IC crónica se basan en atractivas hipótesis como la descompresión de la aurícula izquierda (shunts), la restauración ventricular (compartimentación) o la monitorización intratorácica de presiones mediante dispositivos implantables que permitan tratar precozmente las descompensaciones. Actualmente solo la última se ha probado efectiva en un estudio aleatorizado. Por lo tanto, es necesario estudiar a fondo este dinámico y prometedor campo (AU)

The prevalence of heart failure (HF) has risen in parallel with improved survival in patients after a myocardial infarction and an aging population worldwide. In recent years, new percutaneous therapies have been developed to complement current established treatments for acute/decompensated and chronic HF and minimize risks. In acute presentations, the failure of medical treatment is no longer the end of the road in refractory circulatory shock; the use of mechanical circulatory support devices may be the next milestone in well-resourced health settings. Although evidence in this area is difficult to generate, research networks can facilitate the volume and quality of data needed to further augment the clinician's knowledge. Pulsatile (intra-aortic balloon pump), axial continuous (Impella), or centrifugal continuous pumps (TandemHeart; HeartMate PHP) together with percutaneously implanted extracorporeal membrane oxygenation are radically changing the prognosis of acute HF. Newer percutaneous therapies for chronic HF are based on attractive hypotheses, including left atrial decompression with shunting devices, left ventricle restoration through partitioning devices, or pressure-guided implantable therapies that may help to promptly treat decompensations. To date, only the last has been proved effective in a randomized study. Therefore, thorough research is still needed in this dynamic and promising field (AU)

Current and Future Percutaneous Strategies for the Treatment of Acute and Chronic Heart Failure.

The prevalence of heart failure (HF) has risen in parallel with improved survival in patients after a myocardial infarction and an aging population worldwide. In recent years, new percutaneous therapies have been developed to complement current established treatments for acute/decompensated and chronic HF and minimize risks. In acute presentations, the failure of medical treatment is no longer the end of the road in refractory circulatory shock; the use of mechanical circulatory support devices may be the next milestone in well-resourced health settings. Although evidence in this area is difficult to generate, research networks can facilitate the volume and quality of data needed to further augment the clinician's knowledge. Pulsatile (intra-aortic balloon pump), axial continuous (Impella), or centrifugal continuous pumps (TandemHeart; HeartMate PHP) together with percutaneously implanted extracorporeal membrane oxygenation are radically changing the prognosis of acute HF. Newer percutaneous therapies for chronic HF are based on attractive hypotheses, including left atrial decompression with shunting devices, left ventricle restoration through partitioning devices, or pressure-guided implantable therapies that may help to promptly treat decompensations. To date, only the last has been proved effective in a randomized study. Therefore, thorough research is still needed in this dynamic and promising field.

Delayed left anterior mitral leaflet perforation and infective endocarditis after transapical aortic valve implantation-Case report and systematic review.

AIM: We aimed to illustrate the physiopathology of anterior mitral leaflet perforation after TAVI in patients suffering from infective endocarditis (IE). METHODS AND RESULTS: The first known case of balloon-expandable transapical case from our series suffering from this complication was reported. In addition, a systematic electronic search of all published cases reporting both entities was performed. Five transfemoral cases have been published to the date, all males with mean age of 79.2 year (range: 66-88). Four were treated with self-expandable prostheses (deeply implanted in the outflow tract). There was moderate residual aortic regurgitation in four. Fever and positive blood cultures for typical micoorganisms were present at certain time point in all cases between the first week and up to 11 months (early IE). Three cases underwent cardiac surgery with adequate outcomes and two others died during hospitalization. Medical management in the case from our series allowed patient's survival at 1-year follow up. CONCLUSIONS: Early suspicion of IE whenever anterior mitral perforation is found after TAVI can be life-saving. The hypothetical higher risk of this complication due to higher rate of aortic regurgitation has to be prevented through adequate prosthesis depth and careful sterile surgical technique. © 2016 Wiley Periodicals, Inc.

Acquired Aseptic Intracardiac Shunts Following Transcatheter Aortic Valve Replacement: A Systematic Review.

OBJECTIVES: The aim of this study was to describe the incidence, mechanisms, features, and management of aseptic intracardiac shunts (AICS). BACKGROUND: AICS following transcatheter aortic valve replacement (TAVR) are an uncommon and barely described complication. METHODS: A systematic review was performed of all published cases of AICS following TAVR, and the incidence, predictors, main features, management, and related outcomes were analyzed. RESULTS: A total of 31 post-TAVR AICS were gathered. After excluding transapical fistulas, the 28 remaining cases corresponded with an incidence of about 0.5%. Mean age and mean logistic European System for Cardiac Operative Risk Evaluation score were 80 ± 11 years and 19.2 ± 8.3%, respectively. Prior radiation therapy for cancer was present in 14.3%, and 42.8% had severe calcification of the aortic valve. TAVR was undertaken using balloon-expandable prostheses in the majority of cases (85.7%), via the transapical approach in one-third. Median time from TAVR to diagnosis was 21 days (interquartile range: 7 to 30 days), with intraprocedural suspicion in 12 cases (42.9%) and a mean Qp/Qs ratio of 1.8 ± 0.6. The most common location for AICS was the interventricular septum (60.7%). Heart failure was frequent (46.4%), but 14 patients (50%) remained asymptomatic. Medical treatment (71.4%) was associated with poor outcomes (30-day mortality rate 25%), especially in symptomatic patients (35% vs. 0%; p = 0.020) and in those with higher Qp/Qs ratios (1.9 ± 0.6 vs. 1.4 ± 0.1), while cardiac surgery (3.6%), and percutaneous closure (25%) led to good outcomes after a median follow-up period of 3 months (interquartile range: 1 to 9 months). CONCLUSIONS: Post-TAVR AICS are uncommon but have high 30-day mortality if left untreated, especially in symptomatic patients. Percutaneous closure was feasible and safe in symptomatic patients but remains controversial in asymptomatic subjects.

Propensity score matched comparison of transcatheter aortic valve implantation versus conventional surgery in intermediate and low risk aortic stenosis patients: A hint of real-world.

BACKGROUND: Recently, the use of transcatheter aortic valve implantation (TAVI) in inter-mediate-low risk patients has been evaluated in the PARTNER II randomized trial. However, in the last years, this therapy has been employed in this scenario with underreported results, as compared to surgical aortic valve replacement (SAVR). METHODS: We enrolled 362 consecutive patients with severe symptomatic aortic stenosis and intermediate-low surgical risk (logEuroSCORE < 20%), treated in our center with TAVI (103 patients) or single SAVR (259 patients) between 2009 and 2014. Patients were matched according to age, gender, logEuroSCORE, and use of bioprosthesis. RESULTS: Mean age of the patients was 73 ± 10.4 years, and 40.3% were women. LogEuroSCORE and Society Thoracic Surgeons score were 7.0 ± 4.4% and 4.2 ± 2.5%, respectively, with mean left ventricular ejection fraction of 52 ± 9%. There were no differences regarding other comorbidities. The length-of-hospitalization was 11 ± 5 days after TAVI vs. 17 ± 9 days after SAVR (p = 0.003). After matched comparison, no differences in terms of in-hospital mortality (5.7% after TAVI vs. 2.9% after SAVR, p = 0.687) and 1-year mortality (11.4% vs. 7.1%, p = 0.381) were found. The combined endpoint of stroke and mortality at 1-year was also similar between both groups (15.7% in TAVI patients vs. 14.4% after SAVR, p = 0.136). Multivariate analysis determined that aortic regurgitation (AR) was an independent predictor of mortality (OR = 3.623, 95% CI: 1.267-10.358, p = 0.016). Although the rate of AR was higher after TAVI, none of the patients treated with the newest generation devices (10.7%) presented more than a mild degree of AR. CONCLUSIONS: TAVI is feasible and shows comparable results to surgery in terms of early, 1-year mortality, as well as cerebrovascular events in patients with severe aortic stenosis and intermediate-low operative risk. Better transvalvular gradients, yet higher rates of AR were found, however, newer devices presented comparable rate of AR.

Catheter Entrapment During Posterior Mitral Leaflet Pushing Maneuver for MitraClip Implantation.

MitraClip (Abbott Vascular) therapy has been reported to be an effective procedure for mitral regurgitation, especially in high-risk patients. Recently, the novel pushing maneuver technique has been described for approaching restricted and short posterior leaflets with a pigtail catheter in order to facilitate grasping of the clip. However, complications or unexpected situations may occur. We report the case of an 84-year-old patient who underwent MitraClip implantation wherein the pushing maneuver was complicated by the clip accidentally gripping the pigtail catheter along with the two leaflets.