Transcatheter aortic valve with a novel self-expandable device in patients with previous mechanical mitral valve prosthesis.

OBJECTIVES: The aim of this study was to describe the procedural and early outcomes of patients with mechanical mitral valve prosthesis (MVP) undergoing transcatheter aortic valve replacement (TAVR) with a novel self-expandable retrievable device. BACKGROUND: TAVR in patients with prior MVP may have an increased risk of complications related to device positioning and interference between both prosthetic valves. METHODS: An observational study was conducted, including eight patients with severe symptomatic aortic stenosis and prior mechanical MVP who underwent TAVR with the novel device AllegraTM (Biosensors). No transesophageal monitoring was used. RESULTS: The mean age of the study population was 75 years. The mean distance between MVP and aortic annulus was 3.8 mm. Procedural success was achieved in all patients with no major intraprocedural, in-hospital, or follow-up complications. CONCLUSIONS: TAVR with Allegra TAVI system in patients with prior MVP offers good procedural and clinical outcomes.

Short- and long-term need for permanent pacemaker after transcatheter implantation of the Edwards Sapien aortic valve prosthesis.

INTRODUCTION: A permanent pacemaker is frequently needed after transcatheter aortic valve implantation, but the available data are mainly on the CoreValve system. OBJECTIVE: To evaluate the need for new permanent pacemaker after implantation of the Edwards Sapien device, as well as related factors. METHODS: We included the first 100 patients treated with the Edwards Sapien device at our institution. Of these, 12 had a permanent pacemaker before the procedure, and thus our study population was the remaining 88 patients. RESULTS: A permanent pacemaker was indicated in eight patients (9.1%) during hospitalization or at 30 days. After discharge, another four patients needed a pacemaker (at 42 days and three, 18, and 30 months). Two variables were associated with the need for pacemaker during hospitalization: previous dialysis (13% vs. 1%, p=0.042) and complete right bundle branch block before the procedure (25% vs. 5%, p=0.032). More than one month after the procedure, the characteristics associated with the need for pacemaker were plasma creatinine level (2.5±1.7 vs. 1.3±0.6 mg/dl, p=0.001) and previous myocardial infarction (50% vs. 10%, p=0.013). CONCLUSION: The rate of pacemaker implantation with the Edwards Sapien device was 9.1%. Right bundle branch block and dialysis were associated with this complication.

Cierre percutáneo de fugas perivalvulares mitrales en pacientes con prótesis metálica aórtica / Percutaneous closure of mitral paravalvular leaks in patients with aortic valve prostheses

No disponible

Clinical and prognostic implications of atrial fibrillation in patients undergoing transcatheter aortic valve implantation.

AIM: To study a cohort of consecutive patients undergoing transcatheter aortic valve implantation (TAVI) and compare the outcomes of atrial fibrillation (AF) patients vs patients in sinus rhythm (SR). METHODS: All consecutive patients undergoing TAVI in our hospital were included. The AF group comprised patients in AF at the time of TAVI or with history of AF, and were compared with the SR group. Procedural, echocardiographic and follow-up variables were compared. Likewise, the CHA(2)DS(2)-VASC stroke risk score and HAS-BLED bleeding risk score and antithrombotic treatment at discharge in AF patients were compared with that in SR patients. RESULTS: From a total of 34 patients undergoing TAVI, 17 (50%) were allocated to the AF group, of whom 15 (88%) were under chronic oral anticoagulation. Patients in the AF group were similar to those in the SR group except for a trend (P = 0.07) for a higher logistic EuroSCORE (28% vs 19%), and a higher prevalence of hypertension (82% vs 53%) and chronic renal failure (17% vs 0%). Risk of both stroke and bleeding was high in the AF group (mean CHA(2)DS(2)-VASC 4.3, mean HAS-BLED 2.9). In the AF group, treatment at discharge included chronic oral anticoagulation in all except one case, and in association with an antiplatelet drug in 57% of patients. During a mean follow-up of 11 mo (maximum 32), there were only two strokes, none of them during the peri-procedural period: one in the AF group at 30 mo and one in the SR group at 3 mo. There were no statistical differences in procedural success, and clinical outcome (survival at 1 year 81% vs 74% in AF and SR groups, respectively, P = NS). CONCLUSION: Patients in AF undergoing TAVI show a trend to a higher surgical risk. However, in our cohort, patients in AF did not have a higher stroke rate compared to the SR group, and the prognosis was similar in both groups.

[Transcatheter aortic valve implantation: results of a new therapeutic option for high surgical risk aortic stenosis]. / Implantação percutânea de próteses valvulares aórticas: resultados de uma nova opção terapêutica na estenose aórtica com alto risco cirúrgico.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) is an alternative to surgical aortic valve replacement in patients with severe aortic stenosis (AS) and unacceptably high surgical risk. METHODS: We present our first two years' experience with TAVI. A total of 76 AS patients were evaluated for TAVI and 23 of them underwent a TAVI procedure. These patients had a mean EuroSCORE of 22.4% and a mean age of 81.5 years, and were prospectively followed for a mean of 12.9 ± 11 months. RESULTS: The percutaneous aortic valve was successfully implanted in 100% of the patients. Mortality at 30 days was 4%. The most common complications were access site-related bleeding and transfusion (22%), followed by new permanent pacemaker implantation (9%). After a mean follow-up of 12.9 months, survival was 87%. In a maximum follow-up of 30 months there were no cases of prosthesis dysfunction or cardiovascular death. CONCLUSIONS: Two years after the introduction of a TAVI program in our center, the procedure has established itself as a safe and effective alternative for patients with severe AS and unacceptably high surgical risk.

Causes of peri-operative mortality after transcatheter aortic valve implantation: a pooled analysis of 12 studies and 1223 patients.

BACKGROUND: In order to improve technique and to prevent serious procedural complications during transcatheter aortic valve implantation (TAVI), it is crucial to identify the causes of death of patients undergoing this procedure. OBJECTIVE: The objective of this study was to identify the causes of death during the procedure and at 1 month in patients with severe aortic stenosis undergoing TAVI. METHODS: 12 published studies with information about the causes of death in patients undergoing TAVI were selected. Overall, 1223 patients were included in these studies, and 249 deaths were reported (119 at 1 month and 130 at >1 month post-procedure). Mortality during the procedure and at 1 month was 2.3% and 9.7%, respectively. The proportion of cardiac deaths was higher at <1 month in comparison with >1 month (56% versus 34%, respectively; p = 0.001). At 1 month, the most frequent causes of death were cardiac failure/multi-organ failure (24%), sudden death/cardiac arrest (17%), vascular and bleeding complications (17%), stroke (11%), sepsis (11%), and cardiac tamponade (10%). During the procedure, the most frequent causes of death were cardiac tamponade (39%), cardiac failure (21%), cardiac arrest (18%), and vascular and/or bleeding complications (18%). In patients treated with the CoreValve system (Medtronic, Minneapolis, Minnesota) versus those treated with Edwards valves (Cribier-Edwards, Edwards-SAPIEN or SAPIEN XT valve, Edward Lifesciences, Irvine, California), deaths at 1 month due to vascular and bleeding complications were less frequent (3% versus 22%, respectively; p = 0.019), but those due to cardiac tamponade (26% versus 6%, respectively; p = 0.019), and because of aortic regurgitation (10% versus 0%, respectively; p = 0.03) were more frequent. CONCLUSION: In this pooled analysis, mortality at 1 month after TAVI was 9.7%. The causes of death were widely variable, and of both cardiac and non-cardiac origin. There were some important differences between both devices in the cause of mortality.

Implantación de prótesis valvulares aórticas por vía transfemoral. Evaluación de pacientes candidatos al procedimiento / Implantation of aortic valvular prosthesis via transfemoral catheter. Evaluation of candidates undergoing the procedure

Fundamento y objetivo: El objetivo de este estudio es el de comparar la calidad de vida de pacientes ancianos a los que se les ha realizado cirugía de recambio valvular aórtico (RVA) con la de la población general española de la misma edad y del mismo sexo. Pacientes: Se analizó un total de 163 pacientes con una edad igual o superior a 75 años que habían recibido RVA. La calidad de vida se evaluó con el test SF-12 (Short Form Health Survey 12). La mediana del período de seguimiento fue de 37,4 meses. El seguimiento se completó en un 95,6% de los pacientes supervivientes. Los resultados se compararon con los datos publicados para la población general española de la misma edad y del mismo sexo (n=1.312). Resultados: La mortalidad hospitalaria fue del 7,4%. El resultado medio de los componentes sumarios físico y mental fue para las mujeres de 44,69 y de 49,88, y para los varones de 47,38 y de 56,19, respectivamente. Al confrontarlos con la población general española, los pacientes intervenidos mostraron un estado de salud comparable. Conclusiones: Los pacientes ancianos candidatos a RVA representan un grupo de alto riesgo quirúrgico. Sin embargo, la calidad de vida postoperatoria es comparable a la de la población general de la misma edad y del mismo sexo (AU)

Background and objective: The aim of the study was to compare the quality of life of elderly patients undergoing aortic valve replacement with that of a reference group. Patients: A total of 163 patients aged ⩾75 years who underwent aortic valve replacement were analyzed. Quality of life was evaluated by the Short Form Health Survey test 12 (SF-12). The median follow-up period was 37.4 months. Quality of life follow-up was complete at 95.6% of mid-term survivors. Quality of life data was compared with published data of a sample of the Spanish population (n.1312) of the same age and same sex .Results: Overall 30-day mortality was 7.4%. The mean SF-12 physical component score and SF-12 mental component score of the study population were 44,69 and 49,88 for woman and 47,38 and 56,19 for men, respectively. Results: Our sample population showed a post operative quality of live comparable with that of the general population. Conclusions: Elderly patients who are candidates to aortic valve replacement represent a high risk population. Nevertheless, the quality of life achieved post-operatively is comparable with that of the general population (AU)

[Implantation of aortic valvular prosthesis via transfemoral catheter. Evaluation of candidates undergoing the procedure]. / Implantación de prótesis valvulares aórticas por vía transfemoral. Evaluación de pacientes candidatos al procedimiento.

BACKGROUND AND OBJECTIVE: In recent years, techniques for implantation of aortic prosthesis via catheter have been developed as a therapeutic alternative in patients with severe aortic stenosis rejected for surgery. The correct selection of candidates is one of the more complex aspects of this treatment. We analyzed the acceptance rate in our environment for transcatheter aortic valve implantation in patients referred to our hospital for evaluation as possible candidates, describing the exclusion reasons. PATIENTS AND METHOD: 30 patients with severe aortic stenosis and rejected for surgical aortic valve replacement were referred to our hospital to evaluate transcatheter aortic valve implantation. The patients first underwent clinical evaluation and were studied with echocardiography, angiography and computed tomography. RESULTS: Of the 30 patients, 18 were rejected for the procedure (60%): 4 patients with non-severe aortic stenosis, 2 asymptomatic patients, 2 patients who finally underwent surgery because of a low-surgical-risk, 5 patients with contraindications for the procedure, 2 patients who finally did not want to undergo the procedure and 3 patients were further rejected because the vascular access was inappropriate. Of the remaining 12 patients initially accepted, 3 died before the procedure was performed. Finally, only 9 patients (30%) underwent transcatheter aortic valve implantation. CONCLUSIONS: Of the patients referred for transcatheter aortic valve implantation, only 40% were accepted. The mortality rate during the evaluation process of this procedure is high, showing that these patients are terminally ill.

Percutaneous PFO closure using the Premere device occluder: initial experience.

INTRODUCTION: Most data on percutaneous closure of patent foramen ovale (PFO) relate to devices not specifically designed for this pathology. OBJECTIVE: Our aim in this article is to share our initial experience with the Premere PFO closure system. METHODS: In our hospital 14 consecutive patients presenting cryptogenic stroke underwent percutaneous closure using this device. The device was successfully implanted in 11 of the 14 patients (78.5%). Implantation was impossible in three patients because of a significant atrial septal aneurysm (ASA) or a multiperforated septum. RESULTS: Mean clinical and echocardiographical follow-up was 7 +/- 7 months. A residual shunt was seen in only one patient (9%) three months after device implantation. During follow-up, no device-related complications were observed, such as device thrombosis or fistula. None of the patients presented other significant clinical events such as strokes or arrhythmia. CONCLUSION: According to our experience the Premere is a secure and reliable device for PFO closure, but patients must be selected carefully for implantation to exclude those presenting significant ASA.