Variabilidad interregional en el uso de tecnologías cardiovasculares (2011-2019). Correlación con índices económicos y frecuentación y mortalidad hospitalarias / Interregional variability in the use of cardiovascular technologies (2011-2019). Correlation with economic indicators, admissions, and in-hospital mortality

Introducción y objetivos La igualdad de oportunidades para acceder a avances técnicos de reconocido valor clínico debe ser una prioridad del sistema público de salud. Se analizó la variabilidad entre todas las comunidades autónomas españolas en el uso de técnicas cardiológicas con indicación ya establecida y su relación con indicadores económicos, carga de enfermedad y mortalidad hospitalaria. Métodos Se analizaron los registros de actividad de las asociaciones de la Sociedad Española de Cardiología desde 2011 a 2019 en coronariografía, intervención coronaria percutánea (ICP) general, ICP primaria, desfibrilador automático implantable (DAI), terapia de resincronización cardiaca e implante percutáneo de válvula aórtica (TAVI). Se obtuvieron índices económicos (producto interior bruto y gasto sanitario per cápita) y datos sobre frecuentación y mortalidad hospitalarias reportados en los informes RECALCAR (Recursos y Calidad en Cardiología) de la Sociedad Española de Cardiología. Se analizó el coeficiente de variación en la actividad y la correlación de esta con los índices regionales económicos, de frecuentación y la razón de mortalidad hospitalaria estandarizada por riesgo. Resultados Existe una variación notable en el uso de las tecnologías, especialmente ICP primaria (18%), DAI (22%), terapia de resincronización cardiaca (36%) y TAVI (42%). Solo se observó cierta correlación con la frecuentación de la ICP general y el DAI. No se encontró una correlación significativa entre la penetración de las técnicas y los índices económicos de riqueza y gasto. La correlación con la mortalidad hospitalaria no mostró resultados significativos, aunque es el análisis con más limitaciones, ya que estas técnicas tienen mayor impacto en la supervivencia en el medio y largo plazo. Conclusiones Los resultados del estudio, con sus limitaciones inherentes (AU)

Introduction and objectives Equal opportunities to access technical advances with recognized clinical value should be a priority of the publicly-funded health system. We analyzed variability among all the Spanish autonomous communities in the use of cardiovascular techniques with an established indication and its relationship with economic indicators, burden of disease, and hospital mortality. Method The activity registries of various Associations of the Spanish Society of Cardiology from 2011 to 2019 were analyzed for coronary angiography, overall percutaneous coronary intervention (PCI), primary PCI, implantable cardioverter-defibrillators (ICD), cardiac resynchronization therapy, and transcatheter aortic valve replacement (TAVR). Economic indices (gross domestic product and per capita health care expenditure) were obtained from public sources and data on attendance rates and mortality from the Resources and Quality in Cardiology (RECALCAR) reports of the Spanish Society of Cardiology. We analyzed the coefficient of variation for activity and the correlation of activity with regional economic indices, attendance rates, and risk-adjusted rates of in-hospital mortality. Results We identified wide variability in the use of technologies, especially for primary PCI (18%), ICD (22%), cardiac resynchronization therapy (36%), and TAVR (42%). A certain correlation with attendance rates was seen only for overall PCI and ICD. In general, no significant correlation was found between the use of the techniques and the economic indices of wealth and expenditure. The correlation with in-hospital mortality showed no significant results, although this was the analysis with the greatest limitations because the impact of these techniques on survival is exerted more in the mid- and long-term Conclusions The results of this study, despite its inherent limitations, show marked variability between autonomous communities in the use of cardiovascular technologies (AU)

Resultados clínicos tempranos tras el implante percutáneo de válvula aórtica por acceso transaxilar comparado con el acceso transfemoral. Datos del registro español de TAVI / Early clinical outcomes after transaxillary versus transfemoral TAVI. Data from the Spanish TAVI registry

Introducción y objetivos: El acceso transaxilar (ATx) se ha convertido en el acceso alternativo al transfemoral (ATF), más utilizado en pacientes sometidos a implante percutáneo de válvula aórtica (TAVI). El objetivo principal de este estudio es comparar la mortalidad total hospitalaria y a los 30 días de los pacientes incluidos en el registro español de TAVI a los que se trató por acceso ATx frente a ATF. Métodos: Se analizó a todos los pacientes incluidos en el registro español de TAVI tratados por ATx o ATF. Los eventos hospitalarios y a los 30 días de seguimiento se definieron según las recomendaciones de la Valve Academic Research Consortium. Se evaluó el impacto de la vía de acceso mediante emparejamiento por puntuación de propensión según las características clínicas y ecográficas. Resultados: Se incluyó a 6.603 pacientes, 191 (2,9%) tratados por ATx y 6.412 con ATF. Después del ajuste (grupo de ATx, n=113; grupo de ATF, n=3.035), el éxito del dispositivo fue similar entre ambos grupos (el 94% en el grupo de ATx frente al 95% en el de ATF; p=0,95); sin embargo, se observó un incremento en la tasa de infarto agudo de miocardio (OR=5,3; IC95%, 2,0-13,8; p=0,001), complicaciones renales (OR=2,3; IC95%, 1,3-4,1; p=0,003) e implante de marcapasos (OR=1,6; IC95%, 1,01-2,6; p=0,03) en el grupo de ATx comparado con el de ATF. De mismo modo, la mortalidad hospitalaria y a los 30 días fueron superiores en el grupo de ATx (respectivamente, OR=2,2; IC95%, 1,04-4,6; p=0,039; y OR=2,3; IC95%, 1,2-4,5; p=0,01). Conclusiones: El ATx se asocia con un aumento en la mortalidad total tanto hospitalaria como a los 30 días frente al ATF. Ante estos resultados, el ATx debe considerarse solo en caso de que el ATF no sea posible (AU)

Introduction and objectives: Transaxillary access (TXA) has become the most widely used alternative to transfemoral access (TFA) in patients undergoing transcatheter aortic valve implantation (TAVI). The aim of this study was to compare total in-hospital and 30-day mortality in patients included in the Spanish TAVI registry who were treated by TXA or TFA access. Methods: We analyzed data from patients treated with TXA or TFA and who were included in the TAVI Spanish registry. In-hospital and 30-day events were defined according to the recommendations of the Valve Academic Research Consortium. The impact of the access route was evaluated by propensity score matching according to clinical and echocardiogram characteristics. Results: A total of 6603 patients were included; 191 (2.9%) were treated via TXA and 6412 via TFA access. After adjustment (n=113 TXA group and n=3035 TFA group) device success was similar between the 2 groups (94%, TXA vs 95%, TFA; P=.95). However, compared with the TFA group, the TXA group showed a higher rate of acute myocardial infarction (OR, 5.3; 95%CI, 2.0-13.8); P=.001), renal complications (OR, 2.3; 95%CI, 1.3-4.1; P=.003), and pacemaker implantation (OR, 1.6; 95%CI, 1.01-2.6; P=.03). The TXA group also had higher in-hospital and 30-day mortality rates (OR, 2.2; 95%CI, 1.04-4.6; P=.039 and OR, 2.3; 95%CI, 1.2-4.5; P=.01, respectively). Conclusions: Compared with ATF, TXA is associated with higher total mortality, both in-hospital and at 30 days. Given these results, we believe that TXA should be considered only in those patients who are not suitable candidates for TFA (AU)

Rationale and study design of the RESERVOIR trial: a randomized trial comparing reservoir-based polymer-free amphilimus-eluting stents versus everolimus-eluting stents with durable polymer in patients with diabetes mellitus.

BACKGROUND: Patients with diabetes mellitus (DM) remain at high risk for stent restenosis and adverse cardiovascular events in the drug-eluting stent era. The amphilimus-eluting stent (AES) is a third generation reservoir-based polymer-free drug-eluting stent that has shown promising preliminary results in patients with DM. It has been suggested that the formulation of the drug with fatty acids could not only modulate the drug release in a timely manner but also achieve convenient levels of drug concentration in diabetic cardiac cells. The aim of this trial is to assess the efficacy of the AES in patients with DM compared with the cobalt chromium everolimus-eluting stent with non-erodible polymer (EES). STUDY DESIGN: This is an investigator-initiated, multicenter, randomized clinical trial, performed in patients with DM. A total of 112 diabetic patients receiving glucose-lowering agents and requiring percutaneous revascularization of a de novo lesion will be randomized in a 1:1 fashion to receive AES or EES. The primary endpoint is the neointimal volume obstruction at 9 months, evaluated by optical coherence tomography. Secondary endpoints will include strut coverage, angiographic in-stent late loss and clinical endpoints such as target vessel revascularization or probable/definite stent thrombosis. This study completed the inclusion in October 2013. CONCLUSIONS: The RESERVOIR trial is an investigator-initiated trial that will evaluate whether the polymer-free AES is not inferior to the EES inhibiting the neointimal hyperplasia in patients with DM. These results are also expected to improve our knowledge of the neointimal healing process in this population (Clinicaltrials.gov number NCT01710748).

Predictors and impact of myocardial injury after transcatheter aortic valve replacement: a multicenter registry

BACKGROUND:Cardiac biomarker release signifying myocardial injury post-transcatheter aortic valve replacement (TAVR) is common, yet its clinical impact within a large TAVR cohort receiving differing types of valve and procedural approaches is unknown.OBJECTIVES:This study sought to determine the incidence, clinical impact, and factors associated with cardiac biomarker elevation post TAVR.METHODS:This multicenter study included 1,131 consecutive patients undergoing TAVR with balloon-expandable (58%) or self-expandable (42%) valves. Transfemoral and transapical (TA) approaches were selected in 73.1% and 20.3% of patients, respectively. Creatine kinase-myocardial band (CK-MB) measurements were obtained at baseline and at several time points within the initial 72 h post TAVR. Echocardiography was performed at baseline and at 6- to 12-month follow-up.RESULTS:Overall, 66% of the TAVR population demonstrated some degree of myocardial injury as determined by a rise in CK-MB levels (peak value: 1.6-fold [interquartile range (IQR): 0.9 to 2.8-fold]). A TA approach and major procedural complications were independently associated with higher peak of CK-MB levels (p < 0.01 for all), which translated into impaired systolic left ventricular function at 6 to 12 months post TAVR (p < 0.01). A greater rise in CK-MB levels independently associated with an increased 30-day, late (median of 21 [IQR: 8 to 36] months) overall and cardiovascular mortality (p < 0.001 for all)...

Diabetes mellitus and percutaneous coronary revascularization.

Diabetes mellitus is a complex metabolic disorder with aggressive and progressive cardiovascular expression. This article reviews the main percutaneous techniques and their results in the diabetic population, from the early days of balloon angioplasty to the recently advent of drug eluting stents. As the latter devices may eradicate restenosis, plaque progression will remain the cornerstone for interventional cardiologists and the medical community. Attempts to modify life habits, and a more accurate control of the components of the metabolic syndrome should be the main therapeutic objective to slow down the progression and expansion of the disease.