José M. Hernández-García

Percutaneous implantation of the CoreValve self-expanding aortic valve prosthesis in patients with severe aortic stenosis: early experience in Spain.

INTRODUCTION AND OBJECTIVES The aim of the study was to describe early experience and medium-term follow-up with the CoreValve self-expanding aortic prosthesis at three Spanish hospitals. METHODS The study included patients with severe symptomatic aortic stenosis. Other inclusion criteria were: aortic valve area <1 cm(2) (<0.6 cm(2)/m(2)); aortic valve annulus diameter in the range 20-27 mm; diameter of the ascending aorta at the level of the sinotubular junction < or = 40 mm (small prosthesis) or < or = 43 mm (large prosthesis), and femoral artery diameter >6 mm. RESULTS The study included 108 patients with a mean age of 78.6 + or - 6.7 years, a mean aortic valve area of 0.63 + or - 0.2 cm(2) and a mean logistic EuroSCORE of 16% + or - 13.9% (range, 2.27%-86.4%). After valve implantation, the maximum echocardiographic transaortic valve gradient decreased from 83.8 + or - 23 to 12.6 + or - 6 mmHg. No patient presented with greater than grade-2 residual aortic regurgitation on angiography. The procedural success rate was 98.1%. No patient died during the procedure. Definitive pacemaker implantation was carried out for atrioventricular block in 38 patients (35.2%). At 30 days, all-cause mortality and the rate of the combined endpoint of death, stroke, myocardial infarction or referral for surgery were 7.4% and 8.3%, respectively. The estimated 1-year survival rate calculated using the Kaplan-Meier method was 82.3% (for a median follow-up period of 7.6 months). CONCLUSIONS Our early experience indicates that percutaneous aortic valve replacement is a safe and practical therapeutic option for patients with severe aortic stenosis who are at a high surgical risk.

Factors Predicting and Having an Impact on the Need for a Permanent Pacemaker After CoreValve Prosthesis Implantation Using the New Accutrak Delivery Catheter System

OBJECTIVES The purpose of this study was to evaluate the need for a permanent pacemaker after transcatheter aortic valve implantation with the CoreValve prosthesis (Medtronic, Inc., Minneapolis, Minnesota) using the new Accutrak delivery system (Medtronic, Inc.). BACKGROUND The need for a permanent pacemaker is a recognized complication after transcatheter aortic valve implantation with the CoreValve prosthesis. METHODS Between April 23, 2008 and May 31, 2011, 195 consecutive patients with symptomatic aortic valve stenosis underwent transcatheter aortic valve implantation using the self-expanding CoreValve prosthesis. In 124 patients, the traditional delivery system was used, and in 71 patients, the Accutrak delivery system was used. RESULTS There were no significant differences in baseline electrocardiographic characteristics between the traditional system and the Accutrak patients: PR interval: 153 ± 46 mm versus 165 ± 30 mm, p = 0.12; left bundle branch block: 22 (20.2%) versus 8 (12.7%), p = 0.21; right bundle branch block: 21 (19.3%) versus 8 (12.7%), p = 0.26. The depth of the prosthesis in the left ventricular outflow tract was greater with the traditional system than with the Accutrak system (9.6 ± 3.2 mm vs. 6.4 ± 3 mm, p < 0.001) and the need for a permanent pacemaker was higher with traditional system than with Accutrak (35.1% vs. 14.3%, p = 0.003). The predictors of the need for a pacemaker were the depth of the prosthesis in the left ventricular outflow tract (hazard ratio [HR]: 1.2, 95% confidence interval [CI]: 1.08 to 1.34, p < 0.001), pre-existing right bundle branch block (HR: 3.5, 95% CI: 1.68 to 7.29, p = 0.001), and use of the traditional system (HR: 27, 95% CI: 2.81 to 257, p = 0.004). CONCLUSIONS The new Accutrak delivery system was associated with less deep prosthesis implantation in the left ventricular outflow tract, which could be related to the lower rate of permanent pacemaker requirement.

Transcatheter aortic valve implantation in patients with bicuspid aortic valve: A patient level multi-center analysis

OBJECTIVE We sought to evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with bicuspid aortic valve (BiAV). BACKGROUND BiAV remains a relative contraindication to TAVI resulting in exclusion from TAVI trials and thus limiting data on the clinical performance of transcatheter valves in these patients. METHODOLOGY We conducted an international patient level multicenter analysis on outcomes in patients with BiAV undergoing TAVI. The primary outcome of the study was the combined early safety endpoint--a composite of 30 day mortality, stroke, life-threatening bleeding, acute kidney injury, coronary artery obstruction, major vascular complication and valve related dysfunction. Secondary endpoints included the individual components of the primary endpoint as well as post-TAVI paravalvular leak (PVL), rehospitalization, new pacemaker insertion and device success rates at 30 days and 1 year. RESULTS A total of 108 patients with BiAV were identified in 21 centers in Canada, Spain, Italy, Poland and Singapore who underwent TAVI between January 2005 and March 2014. The composite primary outcome occurred in one quarter of patients (26.9%)--mainly driven by re-intervention for valve malposition (9.3%). The 30-day and 1 year mortality rates were 8.3% and 16.9% respectively with AR ≥ 3+ occurring in 9.6% of patients. Device success was achieved in 85.2% of cases with pacemaker insertion in 19.4%. While PVL was not associated with an increased risk of 30 day or 1 year mortality--Type I BiAV anatomy with left and right cusp fusion had significantly better outcomes than other valve variants. CONCLUSION In selected patients with BiAV and severe aortic stenosis, TAVI appears both safe and feasible with acceptable clinical outcomes. Clinical studies of TAVI in this patient population are warranted.

Alteraciones de la conducción auriculoventricular y predictores de la necesidad de marcapasos tras el implante percutáneo de la prótesis aórtica de CoreValve

Introduccion y objetivos Los cambios en la conduccion auriculoventricular son frecuentes tras el implante percutaneo de la protesis aortica, pero se desconoce que mecanismos estan implicados y su evolucion. Analizamos las alteraciones electrocardiograficas y los predictores de la necesidad de marcapasos tras el implante percutaneo con la protesis aortica CoreValve®. Metodos Entre abril de 2008 y octubre de 2009 se ha tratado a 65 pacientes con estenosis aortica grave sintomatica mediante la protesis aortica CoreValve®. Se analizaron caracteristicas clinicas y electrocardiograficas y predictores de la necesidad de marcapasos por bloqueo auriculoventricular avanzado. Del analisis se excluyo a 3 pacientes por tener marcapasos y a un cuarto paciente que fallecio durante el procedimiento. Resultados La media de edad era 79 ± 7,8 anos y el EuroSCORE logistico, 20% ± 14%. El exito del implante fue del 98,4%. Tras el implante de la protesis, el 47,5% tenia bloqueo de rama izquierda y 21 pacientes (34,4%) precisaron de marcapasos definitivo. La necesidad de marcapasos se relaciono con la mayor profundidad de la protesis en el tracto de salida del ventriculo izquierdo (TSVI) (13 ± 2,5 frente a 8,8 ± 2,8 mm; p Conclusiones Tras el implante de la protesis aortica CoreValve®, un alto porcentaje de pacientes precisan de marcapasos definitivo por bloqueo auriculoventricular avanzado. El unico predictor independiente es la profundidad de la protesis en el TSVI y podria detectar precozmente la necesidad de marcapasos.

The Ibero-American transcatheter aortic valve implantation registry with the CoreValve prosthesis. Early and long-term results

BACKGROUND Transcatheter aortic valve implantation (TAVI) is the recommended therapy for patients with severe aortic stenosis who are not suitable candidates for surgery. The aim of this study was to describe early experience and long-term follow-up with the CoreValve self-expanding aortic prosthesis at 42 Ibero-American hospitals. METHODS Multiple centre observational study including 1220 consecutive patients with symptomatic severe aortic stenosis who are not suitable candidates for surgery and underwent transcatheter aortic valve implantation with the self-expanding Medtronic CoreValve System between December 2007 and May 2012. RESULTS The registry included 1220 consecutive patients with a mean age of 80.8 ± 6.3 years and a mean logistic euroSCORE of 17.8% ± 13%. The procedural success rate was 96.1%. Hospital mortality was 7.3% and combined end-point was 21.3%. Aortic regurgitation after TAVI was present in 24.5% (Sellers grade ≥ 2). The estimated 1-year and 2-year survival rates were 82.1% and 73.4% respectively. The following issues were significant independent risk factors for hospital mortality: acute kidney failure (odds ratio 3.55); stroke (odds ratio 5.72); major bleeding (odds ratio 2.64) and euroSCORE (odds ratio 1.02). Long-term predictors of mortality were diabetes mellitus (hazard ratio 1.59, 95% confidence interval 1.09-2.31), severe chronic obstructive pulmonary disease (hazard ratio 1.85, 95% confidence interval 1.85-2.88), and functional classes NYHA III-IV (hazard ratio 1.31, 95% confidence interval 1.01-1.70). CONCLUSIONS Transcatheter aortic valve implantation constitutes a safe and viable therapeutic option for high operative risk patients with severe aortic stenosis. Long-term prognosis is conditioned by associate comorbidities.

Closure of perivalvular leaks using an Amplatzer occluder.

Reoperation of patients with perivalvular leaks due to heart failure or hemolysis is associated with increased morbidity and mortality. Percutaneous closure using an Amplatzer device offers a promising alternative. We describe our initial experience between 2004 and 2006, during which we used an Amplatzer device in eight patients for the percutaneous closure of perivalvular leaks (four aortic and four mitral). The patients were all symptomatic and had a high surgical risk. Device placement was successful in all patients with mitral leaks and in three with aortic leaks. There were no periprocedural complications. With four of the seven (57%) device placements, there was a significant reduction in the degree of regurgitation and, at 12-month follow-up, only these four patients showed clinical improvements. Of the other three, one required reoperation and two died of non-cardiovascular causes. Percutaneous closure of perivalvular leaks was feasible and safe and can be regarded as a treatment option in patients with a high surgical risk.

Utilización de los dispositivos Amplatzer para el cierre de fugas perivalvulares

La reintervencion de los pacientes con fugas perivalvulares por insuficiencia cardiaca o hemolisis esta asociada a una elevada morbimortalidad. La utilizacion percutanea de los dispositivos Amplatzer supone una alternativa atractiva. Presentamos nuestra experiencia inicial: entre 2004 y 2006 realizamos cierre percutaneo con dispositivo Amplatzer a 8 pacientes con fugas perivalvulares (4 aorticas y 4 mitrales), sintomaticos y con alto riesgo quirurgico. La implantacion del dispositivo fue posible en todas las mitrales y en 3 aorticas. No hubo complicaciones durante el procedimiento. En 4 (57%) de los 7 implantes se logro una reduccion significativa del grado de regurgitacion y, tras 12 meses de seguimiento, solamente estos pacientes mejoraron clinicamente. De los 3 restantes, 1 paciente preciso reintervencion y 2 fallecieron por causa no cardiovascular. El tratamiento percutaneo de las fugas perivalvulares es factible y seguro y puede considerarse como una opcion terapeutica en subgrupos de alto riesgo quirurgico.

Acceso axilar en el implante percutaneo de la valvula aortica: optimizacion del tratamiento endovascular de la estenosis aortica severa

INTRODUCTION AND OBJECTIVES To validate the axillary approach as a safe and efficient option for the transcatheter aortic valve implantation in patients who have contraindication for femoral approach at three Spanish hospitals. METHODS We included patients with severe symptomatic aortic stenosis at very high or prohibitive surgical risk, selected by a multidisciplinary team, for transcatheter aortic valve implantation, and had contraindication to the femoral approach. RESULTS We included 19 of 186 (10.5%) patients, who were implanted a percutaneous aortic valve, between November 2008 and March 2010. The mean age was 78.3 (standard deviation [SD]±8.65) years and 73.7% were males. The mean logistic EuroSCORE was 28.7% (SD±16.3%). The procedural success rate was 100%. After the procedure the maximum transvalve gradient decreased from 81.7 mmHg (SD±21.5) to 15.8 mmHg (SD±5.5), and no patient presented residual aortic regurgitation >2. The all-cause mortality, with a mean follow-up time of 9.2 (SD±3.2) months was 10.5%, and the in-hospital and 30-day mortality rates were 0%. The global incidence of major complications due to the procedure was 15.7%. Definitive pacemaker implantation was carried out for atrioventricular block in 8 patients (44.4%). CONCLUSIONS The axillary approach for transcatheter aortic valve implantation using the CoreValve(®) and contraindication to the femoral approach is safe and efficient for selected patients, with excellent results in terms of success implantation and in hospital and 30-day mortality.

Poor reproducibility of the oral glucose tolerance test in the diagnosis of diabetes during percutaneous coronary intervention

BACKGROUND Early de novo diagnosis of diabetes mellitus in patients admitted with acute coronary syndromes who have undergone percutaneous coronary revascularization may have prognostic implications. The ideal diagnostic method and its time of performance are unknown due to the uncertain reproducibility of the oral glucose tolerance test (OGTT). METHODS We assessed 88 patients with no known diabetes mellitus admitted with an acute coronary syndrome who underwent successful percutaneous revascularization. The patients received an OGTT the day after coronary revascularization (7.7+/-6 days after admittance in hospital) and 1 month later. RESULTS The mean age of the patients was 60.8+/-10.3 years and 82% were men. The most common reason for admission was acute coronary syndrome without ST elevation (42%), followed by acute coronary syndrome with ST elevation (36%) and stable angina (21%). After the first OGTT, 66 patients (75%) were found to have carbohydrate metabolism disorders (41% glucose intolerance and 34% diabetes mellitus). After the second OGTT 39 patients (44.3%) had carbohydrate metabolism disorders (26% glucose intolerance and 18% diabetes mellitus). The correlation between both tests was low (weighted kappa, 0.23+/-0.1; 0.03-0.43) (p=0.02). CONCLUSIONS The correlation of the OGTT done in patients admitted with acute coronary syndromes who underwent percutaneous coronary revascularization the day after admittance and the OGTT 1 month later was poor. The prevalence of carbohydrate intolerance in these patients was high.

Survival and predictive factors of mortality after 30 days in patients treated with percutaneous implantation of the CoreValve aortic prosthesis

BACKGROUND Few data exist on the clinical impact of transcatheter aortic valve implantation (TAVI) in patients with symptomatic aortic stenosis and a high surgical risk. The aim of this study was to determine the survival and the factors predicting mortality after 30 days post-TAVI with the CoreValve prosthesis (Medtronic, Minneapolis, MN). METHODS From April 2008 to October 2010, the CoreValve prosthesis (Medtronic) was implanted in 133 consecutive high-risk surgical patients with symptomatic severe aortic stenosis. RESULTS The mean age was 79.5 ± 6.7 years. The logistic European System for Cardiac Operative Risk Evaluation was 21.5% ± 14%. The implantation success rate was 97.7%. In-hospital mortality was 4.5%, and the combined end point of death, vascular complications, myocardial infarction, or stroke had a rate of 9%. Survival at 12 and 24 months was 84.5% and 79%, respectively, after a mean follow-up of 11.3 ± 8 months. The New York Heart Association functional class improved from 3.3 ± 0.5 to 1.18 ± 0.4 and remained stable at 1 year. A high Charlson index (hazard ratio [HR] 1.44, 95% CI 1.09-1.89, P < .01) and a worse Karnofsky score before the procedure (HR 0.95, 95% CI 0.92-0.99, P = .021) were predictors of mortality after 30 days. CONCLUSIONS Transcatheter aortic valve implantation with the CoreValve prosthesis for patients with aortic stenosis and a high surgical risk is a safe, efficient option resulting in a medium-term clinical improvement. Survival during follow-up depends on the associated comorbidities. Early mortality beyond 30 days is predicted by preoperative comorbidity scores and the functional status of the patient.