Raquel del Valle

Predictive factors, management, and clinical outcomes of coronary obstruction following transcatheter aortic valve implantation: Insights from a large multicenter registry

OBJECTIVES This study sought to evaluate the main baseline and procedural characteristics, management, and clinical outcomes of patients from a large cohort of patients undergoing transcatheter aortic valve implantation (TAVI) who suffered coronary obstruction (CO). BACKGROUND Very little data exist on CO following TAVI. METHODS This multicenter registry included 44 patients who suffered symptomatic CO following TAVI of 6,688 patients (0.66%). Pre-TAVI computed tomography data was available in 28 CO patients and in a control group of 345 patients (comparisons were performed including all patients and a cohort matched 1:1 by age, sex, previous coronary artery bypass graft, transcatheter valve type, and size). RESULTS Baseline and procedural variables associated with CO were older age (p < 0.001), female sex (p < 0.001), no previous coronary artery bypass graft (p = 0.043), the use of a balloon-expandable valve (p = 0.023), and previous surgical aortic bioprosthesis (p = 0.045). The left coronary artery was the most commonly involved (88.6%). The mean left coronary artery ostia height and sinus of Valsalva diameters were lower in patients with obstruction than in control subjects (10.6 ± 2.1 mm vs. 13.4 ± 2.1 mm, p < 0.001; 28.1 ± 3.8 mm vs. 31.9 ± 4.1 mm, p < 0.001). Differences between groups remained significant after the case-matched analysis (p < 0.001 for coronary height; p = 0.01 for sinus of Valsalva diameter). Most patients presented with persistent severe hypotension (68.2%) and electrocardiographic changes (56.8%). Percutaneous coronary intervention was attempted in 75% of the cases and was successful in 81.8%. Thirty-day mortality was 40.9%. After a median follow-up of 12 (2 to 18) months, the cumulative mortality rate was 45.5%, and there were no cases of stent thrombosis or reintervention. CONCLUSIONS Symptomatic CO following TAVI was a rare but life-threatening complication that occurred more frequently in women, in patients receiving a balloon-expandable valve, and in those with a previous surgical bioprosthesis. Lower-lying coronary ostium and shallow sinus of Valsalva were associated anatomic factors, and despite successful treatment, acute and late mortality remained very high, highlighting the importance of anticipating and preventing the occurrence of this complication.

Late Cardiac Death in Patients Undergoing Transcatheter Aortic Valve Replacement Incidence and Predictors of Advanced Heart Failure and Sudden Cardiac Death

BACKGROUND Little evidence exists of the burden and predictors of cardiac death after transcatheter aortic valve replacement (TAVR). OBJECTIVES The purpose of this study was to assess the incidence and predictors of cardiac death from advanced heart failure (HF) and sudden cardiac death (SCD) in a large patient cohort undergoing TAVR. METHODS The study included a total of 3,726 patients who underwent TAVR using balloon (57%) or self-expandable (43%) valves. Causes of death were defined according to the Valve Academic Research Consortium-2. RESULTS At a mean follow-up of 22 ± 18 months, 155 patients had died due to advanced HF (15.2% of total deaths, 46.1% of deaths from cardiac causes) and 57 had died due to SCD (5.6% of deaths, 16.9% of cardiac deaths). Baseline comorbidities (chronic obstructive pulmonary disease, atrial fibrillation, left ventricular ejection fraction ≤40%, lower mean transaortic gradient, pulmonary artery systolic pressure >60 mm Hg; p < 0.05 for all) and 2 procedural factors (transapical approach, hazard ratio [HR]: 2.38, 95% confidence interval [CI]: 1.60 to 3.54; p < 0.001; presence of moderate or severe aortic regurgitation after TAVR, HR: 2.79, 95% CI: 1.82 to 4.27; p < 0.001) independently predicted death from advanced HF. Left ventricular ejection fraction ≤40% (HR: 1.93, 95% CI: 1.05 to 3.55; p = 0.033) and new-onset persistent left bundle-branch block following TAVR (HR: 2.26, 95% CI: 1.23 to 4.14; p = 0.009) were independently associated with an increased risk of SCD. Patients with new-onset persistent left bundle-branch block and a QRS duration >160 ms had a greater SCD risk (HR: 4.78, 95% CI: 1.56 to 14.63; p = 0.006). CONCLUSIONS Advanced HF and SCD accounted for two-thirds of cardiac deaths in patients after TAVR. Potentially modifiable or treatable factors leading to increased risk of mortality for HF and SCD were identified. Future studies should determine whether targeting these factors decreases the risk of cardiac death.

Atrioventricular Conduction Disturbance Characterization in Transcatheter Aortic Valve Implantation With the CoreValve Prosthesis

Background— Atrioventricular (AV) block is one of the most frequent complications of CoreValve transcatheter aortic valve implantation (TAVI). The aim of this study was to analyze the effects of CoreValve implantation on AV conduction. Methods and Results— Electrophysiological study was performed immediately before and after CoreValve implantation in 18 consecutive, permanent pacemaker-free patients. An electrode was placed on the His bundle during valve implantation, and data were continuously recorded during the procedure. With surface ECG, a median (first, third quartile) QRS width of 96 (84, 116) to 150 (121, 164) ms (P=0.001) and PR interval of 180 (159, 216) to 210 (190, 240) ms (P=0.008) were significantly prolonged, and QRS axis was left deviated 30° (−32°, 46°) to −20° (−60°, 2°) (P=0.005). With intracardiac electrograms, the AH (97 [70, 123] to 115 [96, 135] ms, P=0.021) and HV (52 [42, 55] to 60 [50, 70] ms, P=0.002) intervals were increased. At the end of the procedure, we observed significant ECG- or electrophysiological study-persistent conduction disturbances in 14 (78%) patients. Five patients experienced transient changes (2 AV blocks and 3 left bundle branch blocks). Conclusions— CoreValve implantation worsens AV conduction in most patients, either transiently or permanently. This worsening is the result of direct damage either on the His bundle or on the AV node.

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.

Percutaneous Implantation of the CoreValve ® Self-expanding Valve Prosthesis in Patients With Severe Aortic Stenosis and Porcelain Aorta: Medium-term Follow-up

INTRODUCTION AND OBJECTIVES There is little information on the use of transcatheter aortic valve implantation in patients with severe aortic stenosis and porcelain aorta. The primary aim of this study was to analyze death from any cause after CoreValve(®) implantation in patients with severe aortic stenosis, with and without porcelain aorta. METHODS In this multicenter, observational prospective study, carried out in 3 hospitals, percutaneous aortic valves were implanted in 449 patients with severely calcified aortic stenosis. Of these, 36 (8%) met the criteria for porcelain aorta. The primary end-point was death from any cause at 2 years. RESULTS Patients with porcelain aorta more frequently had extracardiac vascular disease (11 [30.6%] vs 49 [11.9%]; P=.002), prior coronary revascularization (15 [41.7%] vs 98 [23.7%]; P=.017), and dyslipidemia (26 [72.2%] vs 186 [45%]; P=.02). In these patients, there was greater use of general anesthesia (15 [41.7%] vs 111 [16.9%]; P=.058) and axillary access (9 [25%] vs 34 [8.2%]; P=.004). The success rate of the procedure (94.4 vs 97.3%; P=.28) and the incidence of complications (7 [19.4%] vs 48 [11.6%]; P=.20) were similar in both groups. There were no statistically significant differences in the primary end point at 24 months of follow-up (8 [22.2%] vs 66 [16%]; P=.33). The only predictive variable for the primary end point was the presence of complications during implantation (hazard ratio=2.6; 95% confidence interval, 1.5-4.5; P=.001). CONCLUSIONS In patients with aortic stenosis and porcelain aorta unsuitable for surgery, percutaneous implantation of the CoreValve(®) self-expanding valve prosthesis is safe and feasible.

Estenosis aórtica y aorta de porcelana, ¿el implante valvular percutáneo podría ser una opción terapéutica válida?

El implante transcatéter de prótesis valvular aórtica (TAVI, en glés) se ha consolidado en los últimos años como una alternativa caz y segura para el tratamiento de la estenosis valvular aórtica vera sintomática en pacientes de riesgo quirúrgico elevado. ra la selección de los candidatos se utilizan escalas de riesgo más usada es EuroSCORE) que valoran las comorbilidades ociadas de cada paciente y cuantifican el riesgo quirúrgico de odo individualizado. En nuestro medio, algunos pacientes son considerados inopebles por padecer comorbilidades dependientes de la anatomı́a rtica, que no se incluyen entre las variables del EuroSCORE, como existencia de una aorta de porcelana. Hay alternativas irúrgicas no convencionales (p. ej., el tubo ápico-aórtico) de s que no se han descrito series con suficiente seguimiento. La aorta de porcelana es una enfermedad estructural de la pared rtica definida como la calcificación extensa y circunferencial de aorta torácica, determinada mediante tomografı́a computarida (TC) o fluoroscopia. La frecuencia de presentación de aorta en rcelana en diferentes series de pacientes con estenosis aórtica atados con TAVI es variable y puede alcanzar un 18%. Esta y los alos accesos vasculares son las dos razones principales para dicar el acceso transapical en el tratamiento con TAVI. ao so pr de de tr pr

Real Structural Valve Deterioration of the Mitroflow Aortic Prosthesis: Competing Risk Analysis

INTRODUCTION AND OBJECTIVES The Mitroflow aortic prosthesis is a bovine pericardial bioprosthesis specially designed to increase the valve area in relation to its size. There is controversy regarding the pattern of structural valve deterioration (SVD). Our aim was to determine the cumulative incidence of SVD, risk factors influencing its occurrence, and its impact on mortality. METHODS A total of 1028 patients were clinically and echocardiographically followed up. Because the study population was elderly and had heart disease, we used a competing risk analysis. RESULTS The percentage of patients with SVD at 5 years was 4.22% (95%CI, 2.96-5.81) and was 15.77% at 8 years (95%CI, 12.46-19.43). The incidence was higher for small valves (19mm and 21mm) reaching 6.43% at 5 years (95%CI, 4.48-8.84) and 20.06% at 8 years (95%CI, 15.53-25.01). Severe patient-prosthesis mismatch (PPM) influenced the incidence of SVD (sHR, 3.53; 95%CI, 2.20-5.66; P < .001) but moderate PPM had no impact. The most powerful predictor of mortality was the presence of SVD (HR, 4.59; 95%CI, 2.91-7.22; P < .001). CONCLUSIONS This study used a definition based on the increase in the transprosthetic gradient and found a higher incidence of SVD of the Mitroflow prosthesis than that reported by other series, especially for sizes 19mm and 21mm and in patients with severe PPM. The incidence of SVD increased exponentially from the fifth year after implantation and its occurrence led to a 4.5-fold increase in the risk of death.

The importance of echocardiography in transcatheter aortic valve implantation: TAVI: a multimodality approach.

recently publishedin your journal about the importance of echocar-diography in transcatheter aortic valve implanta-tion (TAVI). We completely agree with theauthors regarding the major role of echocardiog-raphy in the selection of patients, prior to proce-dure, during the procedure, and also in thefollow-up. However, we think that in the era ofmultimodality imaging different techniques mustbe take into account, to provide a comprehen-sive assessment before and post TAVI. In thisaspect, multidetector computed tomography(MCT) plays an important role in patient screen-ing before TAVI, provides detailed anatomicassessment of the aortic root and valve annulus,assesses the suitability of iliofemoral access, anddetermines appropriate coaxial angles to opti-mize the valve implantation procedure.

Transapical Implantation in the Catheterization Laboratory of the Second Generation Engager Aortic Valve

Implantation of aortic valve prosthesis is the treatment of choice for patients with severe and symptomatic aortic valve stenosis unamenable to surgery. It is thus an alternative to surgery for high-risk patients. Second generation aortic valve prostheses have been developed to overcome the limitation of the devices currently used, namely, poor affixation and device embolization, perivalvular aortic regurgitation, and atrioventricular conduction disorders. One of these second generation devices is the Engager Aortic Valve (Medtronic Inc, Minneapolis, Minnesota, United States) for transapical implantation. The device can be repositioned and recaptured and it is designed to achieve an anatomical orientation, thereby helping reduce paravalvular regurgitation. In this article, we describe the first experience reported in Spain of the transapical implantation of this prosthesis in a catheterization laboratory. Medtronic’s biological Engager device has 3 leaflets of bovine pericardium affixed to a nitinol structure. It has a central, self-expanding frame whose proximal part is attached to left ventricular outflow tract. This frame has an external polyester skirt and a support structure and is affixed in 3 places to the aortic part of the central frame (the so-called commissural posts) between which 3 control arms are located, anchored to the base of the sinus of Valsalva. It is available in a size of 26 mm (while drafting this

Indicaciones del TAVI. ¿En qué se basan?

Resumen En este articulo se resume la evidencia disponible para el empleo del implante valvular aortico transcateter como tratamiento de eleccion para los pacientes con estenosis aortica grave sintomatica considerados inoperables y con esperanza de vida superior a 1 ano. Tambien se resume la evidencia disponible acerca de la no inferioridad del implante valvular aortico transcateter en comparacion con el recambio valvular aortico en pacientes de elevado riesgo quirurgico, por lo que se lo considera una alternativa valida a la cirugia. Finalmente se expone la experiencia reportada respecto a la aplicabilidad de este tratamiento en otros escenarios clinicos en los que se puede convertir, en un futuro cercano, en una alternativa terapeutica solida al recambio valvular aortico quirurgico.