Isaac Pascual

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.

Safety and efficacy of transcatheter aortic valve implantation in nonagenarian patients.

Degenerative aortic stenosis (AS) is the leading cause of valvular heart disease in our setting. Prevalence is increasing due to longer life expectancy and gradual population aging. Transcatheter aortic valve implantation (TAVI) is a safe and effective treatment for severe degenerative AS in patients in whom surgery is high risk or contraindicated. The main studies assessing the effectiveness of TAVI have not specifically analyzed the outcome of TAVI in very elderly patients. The aim of this study was to describe the safety and efficacy of TAVI in nonagenarian patients with major functional limitations secondary to severe degenerative AS. We conducted a multicenter, prospective, observational study from December 2008 until April 2012, enrolling 19 consecutive patients with severe degenerative AS aged 90 years and older from 3 hospitals in Spain: Hospital Virgen de la Victoria in Malaga (n = 8), Hospital Universitario Central de Asturias in Oviedo (n = 6), and the Complexo Hospitalario Universitario in Santiago de Compostela (n = 5). All patients were implanted with a self-expanding CoreValve prosthesis (Medtronic; Minneapolis, Minnesota, United States). We included patients aged 90 years and older with severe, symptomatic AS, who met anatomic implantation requirements as described in the literature. Surgical risk was assessed using the logistic EuroSCORE. A multidisciplinary team assessed each case to determine the indication for TAVI. We used the SPSS software package for basic descriptive statistics and to perform a KaplanMeier survival analysis. The baseline characteristics of the study population are shown in the Table. There were 2 major vascular complications, which were common femoral occlusion after percutaneous closure, solved by implanting a coated stent, and acute right iliac occlusion on valve removal, which required emergency vascular surgery and resulted in the patient’s death. There were no other complications. Mean hospital stay was 10.8 days (standard deviation, 4 days). Follow up was performed onsite or by telephone (February 2014). During the follow-up period (median, 1080 days [interquartile range, 823-1329 days]), there were no cerebrovascular accidents and 4 deaths, 2 of which were of cardiovascular origin and occurred in hospital (1 as described above for acute iliac occlusion and 1 due to refractory heart failure and multiple organ failure). The other 2 deaths were not cardiovascular-related and occurred at 846 days and 999 days post-implantation. Total survival (Figure) was 76.2%, with an estimated median survival of 1472 days (95% confidence interval, 1203.8-1740.1 days). Our case series shows that TAVI treatment in heart teamselected nonagenarian patients with severe, limiting, degenerative AS is safe and effective, despite their high-risk classification determined using the EuroSCORE. These patients are usually treated conservatively, regardless of the poor prognosis associated with medical treatment. In this respect, the results observed in our study are of key clinical importance because, in very elderly patients, age alone may be the main criterion to contraindicate surgery in the absence of other significant comorbidities (the EuroSCORE places considerable weight on advanced age). In our setting, in which life expectancy is increasing, it is common to see elderly patients with good quality of life, principally limited by a degenerative disease such as severe AS. We observed a high success rate for TAVI, matching data published in other series in which age was not a selection criterion. Complications Age, mean (SD), y 92 [90.1-93]

Vascular approaches for transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) is a rapidly evolving therapeutic modality currently available for patients with severe aortic stenosis (AS) that are unsuitable for surgery because of technical/anatomical issues or high-estimated surgical risk. Transfemoral approach is the preferred TAVI delivery route when possible. Alternative non-transfemoral access options include transaortic, trans-subclavian and transapical access. Other approaches are also feasible (transcarotid, transcaval, and antegrade aortic) but are restricted to operators and hospitals with experience. The peculiarities of each of the vascular approaches designed for TAVI delivery make it necessary to carefully assess patients atherosclerotic load and location, arterial size and tortuosity, and presence of mural thrombus. Several clinical trials are currently ongoing and in the near future the indications for these approaches will likely be better defined and extended to a broader spectrum of TAVI candidates.

Will TAVI Be the Standard of Care in the Treatment of Aortic Stenosis

Aortic stenosis (AS) is the most common valvular heart disease in developed countries. The prevalence of AS increases with age and varies from 0.2% at ages 50 to 59 years to 1.3% at 60 to 69 years, 3.9% at 70 to 79 years, and 9.8% at 80 to 89 years. Importantly, it is estimated that up to 1.3 million patients in Europe and nearly 1 million patients in the United States will develop severe symptomatic AS by 2025 and that these figures will double by the year 2050. Transcatheter aortic valve implantation (TAVI) has revolutionized the treatment of AS. Worldwide, TAVI is available in more than 65 countries with more than 250 000 implants to date. More than 70 000 cases have been implanted in 2015 and this number is likely to quadruple to over 280 000 by 2025. The adoption of TAVI has been somewhat uneven across different European countries, varying from 160 TAVI units/million inhabitants to 10 to 20 per million. This is determined mainly by local health policy and reimbursement. TAVI has become the standard of care for inoperable patients and the preferred treatment option for high-risk patients. In this article, we discuss the current status of this technique and offer a prediction for what TAVI may hold in the future.

Acceso aórtico directo para implante transcatéter de la válvula aórtica autoexpandible CoreValve ®: serie de dos casos

En pacientes con gran estenosis aórtica y elevado riesgo quirúrgico, el implante de prótesis transcatéter es una opción eficaz y segura. Hay dos prótesis disponibles, CoreValve de Medtronic y SAPIEN de Edwards Lifesciences. En casos con mal acceso vascular se puede utilizar el acceso transapical, sólo disponible para la prótesis SAPIEN; suelen ser pacientes con EuroSCORE superior que sufren más mortalidad y complicaciones. Como alternativa para casos seleccionados en los que no exista una vı́a de acceso vascular adecuada, para el implante de la válvula CoreValve se puede considerar el acceso directo por aorta ascendente a través de una estereotomı́a o toracotomı́a intercostal. Recientemente se ha descrito este acceso como tratamiento de una bioprótesis degenerada y una insuficiencia aórtica severa 1 semana después del implante de una prótesis SAPIEN. En este trabajo se presentan dos casos de gran estenosis aórtica degenerativa tratados mediante prótesis transcatéter CoreValve a través de acceso aórtico directo, realizados en dos hospitales españoles por un grupo mixto de cardiólogos intervencionistas y cirujanos cardiovasculares. El primer caso es un varón de 83 años, hipertenso y con fibrilación auricular crónica anticoagulada. Presentaba gran estenosis aórtica y disfunción grave del ventrı́culo izquierdo (fracción de eyección del ventrı́culo izquierdo, 35%), con varios ingresos por angina e insuficiencia cardiaca. Los gradientes aórticos máximo y medio por ecocardiograma con perfusión de dobutamina fueron 66 y 35 mmHg respectivamente. El área calculada fue 0,8 cm, el anillo aórtico midió 22 mm y la aorta ascendente, 45 mm con disposición muy horizontal. No se documentó enfermedad coronaria significativa. Las arterias femorales comunes tenı́an diámetros < 6 mm y subclavias < 4 mm. El EuroSCORE logı́stico fue del 35,3%. El paciente rechazó el recambio valvular quirúrgico. Se implantó prótesis CoreValve de 26 mm por vı́a aórtica directa tras valvuloplastia, con buen resultado y in complicaciones. El r o a

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

Long-term Follow-up of Patients With Severe Aortic Stenosis Treated With a Self-expanding Prosthesis

INTRODUCTION AND OBJECTIVES Transcatheter aortic valve implantation (TAVI) is a safe and effective alternative to surgical treatment in patients with severe aortic stenosis (AS) and those who are inoperable or at high surgical risk. The primary objective of this study was to evaluate the long-term survival of consecutive patients with severe AS treated with TAVI. METHODS Observational, multicenter, prospective, follow-up study of consecutive patients with severe symptomatic AS treated by TAVI in 3 high-volume hospitals in Spain. RESULTS We recruited 108 patients, treated with a self-expanding CoreValve prosthesis. The mean age at implantation was 78.6 ± 6.7 years, 49 (45.4%) were male and the mean logistic EuroSCORE was 16% ± 13.9%. The median follow-up was 6.1 years (2232 days). Survival rates at the end of years 1, 2, 3, 4, 5, and 6 were 84.3% (92.6% after hospitalization), 77.8%, 72.2%, 66.7%, 58.3%, and 52.8%. During follow-up, 71 patients (65.7%) died, 18 (25.3%) due to cardiac causes. Most (82.5%) survivors were in New York Heart Association class I or II. Six patients (5.5%) developed prosthetic valve dysfunction. CONCLUSIONS Long-term survival in AS patients after TAVI is acceptable. The main causes of death are cardiovascular in the first year and noncardiac causes in subsequent years. Valve function is maintained over time.

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.

Bicuspid aortic valve syndrome: a multidisciplinary approach for a complex entity

Bicuspid aortic valve (BAV) or bicuspid aortopathy is the most common congenital heart disease. It can be clinically silent and it is often identified as an incidental finding in otherwise healthy, asymptomatic patients. However, it can be dysfunctioning at birth, even requiring neonatal intervention, or, in time, lead to aortic stenosis, aortic insufficiency, and endocarditis, and also be associated with aortic aneurysm and aortic dissection. Given its prevalence and significant complications, it is estimated that BAV is responsible for more deaths and morbidity than the combined effects of all the other congenital heart defects. Pathology of BAV is still not well known and many questions are unresolved. In this manuscript we review some aspects on bicuspid aortopathy, a heterogeneous and frequent disease in which like some authors have previously described, complex gene environment are present. Further investigations and, what is more, multidisciplinary teams are needed to improve our knowledge on this really fascinating disease.

Long-term Outcome of Cirrhotic Patients With Severe Aortic Stenosis Treated With Transcatheter Aortic Valve Implantation

Transcatheter aortic valve implantation (TAVI) has become consolidated in recent years as a safe and effective alternative treatment for patients with severe symptomatic aortic stenosis with high surgical risk. The most commonly used scales for calculating preoperative surgical risk are the EuroSCORE (European System for Cardiac Operative Risk Evaluation)—the preferred scale in our setting—and the STS (Society of Thoracic Surgeons) scale. However, these risk scales do not include some conditions, such as porcelain aorta, frailty, and liver cirrhosis, which also have increased surgical risk. Patients with cirrhosis who undergo cardiac surgery are at increased risk of perioperative mortality and morbidity. These patients are more likely to have serious coagulopathy and multiorgan dysfunction associated with cardiopulmonary bypass, and treatment with TAVI could be a therapeutic alternative. There are no conclusive data regarding the role of TAVI in patients with severe aortic stenosis and liver cirrhosis. The aim of this article is to describe the results in a series of such patients treated with TAVI. Between June 2008 and September 2011, 10 consecutive patients with severe aortic stenosis and liver cirrhosis were treated with TAVI. The patients came from 3 Spanish hospitals: Hospital Virgen de la Victoria in Malaga (n = 7), Hospital Universitario Central de Asturias in Oviedo (n = 2) and Complexo Hospitalario Universitario in Santiago de Compostela (n = 1). Prior to implantation, the patients were evaluated by a multidisciplinary team: 7 patients were ineligible for surgery, and 3 refused to undergo surgery. We assessed surgical risk according to the logistic EuroSCORE, and the degree of severity of cirrhosis according to the Child-Pugh International Classification. This classification has 3 grades, A, B and C, from lowest to highest severity of liver failure. The self-expanding CoreValve prosthesis (Medtronic, Minneapolis, Minnesota, United States) was implanted in all patients. Follow-up was conducted until June 30, 2014, via direct contact with the patients themselves or close relatives. The primary objective of the study was to analyze mortality due to any cause. We performed a basic descriptive statistical analysis and survival analysis (Kaplan-Meier) using SPSS (Chicago, Illinois, United States). The baseline characteristics of the population are shown in the Table. Notably, the mean age was lower than in other series. The mean (SD) EuroSCORE was 9.7 (6.4) and 1 patient showed a EuroSCORE > 20. Ninety percent of patients were in functional class III or IV. One patient had chronic renal failure, another had left ventricular ejection fraction < 50%, and another was treated for deterioration of an aortic valve bioprosthesis. Liver cirrhosis classification was Child-Pugh grade A in 7 patients (including the 3 patients who refused surgery), A5 in 3 patients, A6 in 2 patients, grade B in 2 patients (B7 and B9), and grade C in 1 patient. The procedure was performed under heavy sedation, under general anesthesia in 9 patients, and using mechanical ventilation in 1 patient. The percutaneous femoral access route was used in all patients, with subsequent percutaneous closure. No deaths occurred during hospitalization or during the 30 days following implantation. One patient had major bleeding complications secondary to perforation of the femoral artery, which was treated by implantation of a coated stent. One patient required implantation of a second valve. The mean (SD) hospital stay was Table Baseline Characteristics of the Sample