Prevención primaria con cardiodesfibrilador implantable y terapia de resincronización cardíaca en pacientes ancianos: resultados de un estudio multicéntrico español

Propósito: a la fecha sigue sin haber pruebas en cuanto a los resultados del uso de dispositivos para arritmias ventriculares en pacientes añosos, y menos aun para indicaciones de prevención primaria. La finalidad del estudio fue describir la evolución en términos de la eficacia y seguridad de la terapia con cardiodesfibriladores implantables (CDI) en una gran cohorte de pacientes añosos. Métodos y resultados: estudio multicéntrico retrospectivo realizado en 15 hospitales españoles. Se incluyeron pacientes consecutivos referidos para implante de CDI antes de 2011. Se consideró que 162 de los 1.174 pacientes (13,8%) con 75 años o más eran “añosos”. Comparado con aquellos pacientes <75 años, este subgrupo presentaba más comorbilidades como hipertensión, enfermedad pulmonar obstructiva crónica y falla renal, y más internaciones previas debido a insuficiencia cardíaca (IC). A lo largo de una media de seguimiento de 104,4 ± 3,3 meses, fallecieron 162 pacientes (14%), 120 de los más jóvenes (12,4%) y 42 (24,4%) de los añosos. El análisis de Kaplan-Meier mostró un aumento de la probabilidad de morir con el aumento de la edad (17, 24, 28, y 69% a los 12, 24, 48, y 60 meses de seguimiento en el grupo de pacientes añosos). No hubo diferencias entre la tasa de intervenciones con CDI apropiadas o inapropiadas. Conclusión: en el mundo real, los pacientes añosos constituyen ~15% de los implantes de CDI para prevención primaria de la muerte súbita cardíaca (MSC). Si bien la tasa de terapias apropiadas es similar en los diferentes grupos, el beneficio de CDI se ve atenuado por un mayor aumento del riesgo de mortalidad entre los pacientes que son mayores de 75 años al momento del implante.

Terapia de resincronización cardíaca para sujetos con insuficiencia cardíaca asintomáticos o levemente sintomáticos: Un cambio de paradigma: del rescate a la prevención

Hacia fines de la década de 1990 comenzó a utilizarse con éxito la estimulación cardíaca en ambas cámaras ventriculares (resincronización venticular) como terapia en insuficiencia cardíaca refractaria al tratamiento farmacológico convencional en pacientes con complejo QRS ensanchado. Fue hasta el 2005 que el estudio CARE-HF demostró que la resincronización reducía la mortalidad en forma significativa, incluso sin necesidad de acompañarla de un cardiodesfibrilador implantable (DAI o desfibrilador automático implantable). En forma más reciente, a través de los estudios REVERSE, MADIT-CRT y RAFT, se ha comprobado la utilidad de la terapia de resincronización incluso en individuos con insuficiencia cardíaca poco sintomática, es decir en clase funcional I o II, lo cual constituye un cambio cualitativo y cuantitativo en este tratamiento eléctrico para la insuficiencia cardíaca. Al mismo tiempo se han hecho significativos avances en la selección del paciente considerando la enfermedad de base, el patrón de bloqueo en el electrocardiograma, la duración del complejo QRS, y la presencia o no de fibrilación auricular. Como resultado de esto, la terapia de resincronización ha producido mejoría en la calidad de vida, ha demostrado que favorece el fenómeno de remodelado inverso y que también disminuye la mortalidad en individuos en clase funcional I o II.

New encapsulating materials for implantable devices

Synthetic, natural, or composite, biomaterials occupy a key position in the management of disease and support continuous advancement of health care. Clinical utility of many permanent and biodegradable implants can be significantly improved via surface modification. Here, we discuss a novel polymer material developed from essential oil-based monoterpene alcohol using plasma polymerisation. The developed coatings are cytocompatible and limit adhesion and proliferation of a variety of pathogens. The coating can also be used to control degradation behaviour of resorbable materials, such as magnesium.

Implantable devices: issues and challenges

Ageing population and a multitude of neurological and cardiovascular illnesses that cannot be mitigated by medication alone have resulted in a significant growth in the number of patients that require implantable electronic devices. These range from sensors, gastric and cardiac pacemakers, cardioverter defibrillators, to deep brain, nerve, and bone stimulators. Long-term implants present specific engineering challenges, including low energy consumption and stable performance. Resorbable electronics may offer excellent short-term performance without the need for surgical removal. However, most electronic materials have poor bio- and cytocompatibility, resulting in immune reactions and infections. This paper reviews the current situation and highlights challenges for future advancements.

A novel implantable multichannel silicon-based microelectrode

Silicon-based microelectrodes have been confirmed to be helpful in neural prostheses. The fabricated 7-channel silicon-based microelectrode was feasible to be implanted into the brain cortex. The manufacturing process by microelectromechanical system (MEMS) technology was detailed with four photolithographic masks. The microscopic photographs and SEM images indicated that the probe shank was 3mm long, 100 mu m wide and 20 mu m thick with the recording sites spaced 120 mu m apart for good signal isolation. To facilitate the insertion and minimize the trauma, the microelectrode is narrowed down gradually near the tip with the tip taper angle of 6 degrees. Curve of the single recording site impedance versus frequency was shown by test in vitro and the impedance declined from 150.5 k Omega to 6.0 k Omega with frequency changing from 10 k to 10MHz.

Subretinal implantable micro photodetector array

A subretinal implant device, Micro Photo Diode Array, which can partly imitate the function of photoreceptor cells, was presented. Process to fabricate the MPDA and characteristics of the MPDA in vivo were described.

Implantable Microsystem for Wireless Neural Recording Applications

A prototype microsystem is presented for wireless neural recording application. An inductive link was built for transcutaneous wireless power transfer and data transmission. Total 16.5 mW power and 50 bps - 2.5 Kbps command data can be received over 1 - 5 MHz with a distance of 0-10 mm. The integrated amplifiers were designed with a limited bandwidth for neural signals acquisition. The gain of 60 dB was obtained by preamplifier at 7 Hz - 3 KHz. An integrated FM transmitter was used to transmit the extracted neural signals to external equipments with 0.374 - 2 mW power comsumption and a maximum data rate of 500 Kbps at 100 MHz. All the integrated circuits modules except the power recovery circuit were tested or stimulated under a 3.3 V power supply, and fabricated in standard CMOS processing.

Subretinal implantable artificial photoreceptor

The present study reports a subretinal implant device which can imitate the function of photoreceptor cells. Photodiode (PD) arrays on the chip translate the incident light into current according to the intensity of light. With an electrode at the end of every photodiode, the PDs transfer the current to the remnant healthy visual cells such as bipolar cells and horizontal cells and then activate these cells. Biocompatible character of the materials and artificial photoreceptor itself were tested and the photoelectric characteristics of the chips in simulative condition were described and discussed.

Guidelines on the management of implantable cardioverter defibrillators at the end of life

El presente artículo es un documento conjunto de la Sociedad Española de Geriatría y Gerontología, la Sociedad Española de Cuidados Paliativos y la Sección de Cardiología Geriátrica de la Sociedad Española de Cardiología. Su objetivo es paliar la laguna que existe en España en lo que respecta al manejo de los desfibriladores automáticos implantables (DAI) en las fases finales de la vida. Cada vez es más frecuente encontrarse enfermos portadores de DAI en fase terminal de una enfermedad avanzada, como insuficiencia cardíaca refractaria, enfermedades oncológicas, otras insuficiencias orgánicas o enfermedades neurodegenerativas con mal pronóstico a corto plazo. La enorme mayoría de estos pacientes tiene más de 65 años, por ello el documento se enfoca de forma particular a los ancianos que se encuentran en esta situación, aunque el proceso de toma de decisiones es similar en portadores de DAI más jóvenes que están en la fase final de su vida.

Heart Rhythm UK position statement on clinical indications for implantable cardioverter defibrillators in adult patients with familial sudden cardiac death syndromes

Whilst the decision regarding defibrillator implantation in a patient with a familial sudden cardiac death syndrome is likely to be most significant for any particular individual, the clinical decision-making process itself is complex and requires interpretation and extrapolation of information from a number of different sources. This document provides recommendations for adult patients with the congenital Long QT syndromes, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia, hypertrophic cardiomyopathy, and arrhythmogenic right ventricular cardiomyopathy. Although these specific conditions differ in terms of clinical features and prognosis, it is possible and logical to take an approach to determining a threshold for implantable cardioveter-defibrillator implantation that is common to all of the familial sudden cardiac death syndromes based on estimates of absolute risk of sudden death. Published on behalf of the European Society of Cardiology. © The Author 2010.

The mechanical and rheological characterisation of implantable medical devices formulated from binary mixtures of cellulose derivatives

This study highlights the potential associated with utilising multi-component polymeric gels to formulate materials that possess unique rheological and mechanical properties. The synergistic effect* and interaction between hydroxyethylcellulose (HEC) and sodium carboxymethylcellulose (NaCMC), polymers which are commonly employed as drug delivery platforms for implantable medical devices (1), have been determined using dynamic, continuous shear and texture profile analysis. * The difference between the actual response of a binary mixture and the sum of the two components comprising the mixture Increases in polymer concentration resulted in an increase in G', G? and ?' whereas tan d decreased. Similarly, significant increases were also apparent in continuous shear and texture analysis. All binary mixtures showed positive synergy values which may suggest associative interaction between the two components.

Robust implantable antenna for in-body communications

A compact implantable printed meandered folded dipole antenna with a volume of 101.8 mm3 and robust performance is presented for operation in the 2.4 GHz medical ISM bands. The implant antenna is shown to maintain its return loss performance in the 2360???2400 MHz, 2400???2483.5 MHz and 2483.5???2500 MHz frequency bands, simulated in eleven different body tissue types with a broad range of electrical properties. Bandwidth and resonant frequency changes are reported for the same antenna implanted in high water content tissues such as muscle and skin as well as low water content tissues such as subcutaneous fat and bone. The antenna was also shown to maintain its return loss performance as it was moved towards a tissue boundary within a simulated phantom testbed.

Correcting Interdevice Bias of Horizontal White-to-White and Sulcus-to-Sulcus Measures Used for Implantable Collamer Lens Sizing.

PURPOSE: To assess the agreement and repeatability of horizontal white-to-white (WTW) and horizontal sulcus-to-sulcus (STS) diameter measurements and use these data in combination with available literature to correct for interdevice bias in preoperative implantable collamer lens (ICL) size selection. DESIGN: Interinstrument reliability and bias assessment study. METHODS: A total of 107 eyes from 56 patients assessed for ICL implantation at our institution were included in the study. This was a consecutive series of all patients with suitable available data. The agreement and bias between WTW (measured with the Pentacam and BioGraph devices) and STS (measured with the HiScan device) were estimated. RESULTS: The mean spherical equivalent was -8.93 ± 5.69 diopters. The BioGraph measures of WTW were wider than those taken with the Pentacam (bias = 0.26 mm, P < .01), and both horizontal WTW measures were wider than the horizontal STS measures (bias >0.91 mm, P < .01). The repeatability (Sr) of STS measured with the HiScan was 0.39 mm, which was significantly reduced (Sr = 0.15 mm) when the average of 2 measures was used. Agreement between the horizontal WTW measures and horizontal STS estimates when bias was accounted for was г = 0.54 with the Pentacam and г = 0.64 with the BioGraph. CONCLUSIONS: Large interdevice bias was observed for WTW and STS measures. STS measures demonstrated poor repeatability, but the average of repeated measures significantly improved repeatability. In order to conform to the US Food and Drug Administration's accepted guidelines for ICL sizing, clinicians should be aware of and account for the inconsistencies between devices.

Évaluation d’une intervention infirmière basée sur une approche caring et cognitive comportementale sur l’acceptation d’un défibrillateur cardiaque implantable

Le taux de mortalité chez les patients à risque d’arythmies cardiaques menaçantes à la vie a été considérablement réduit grâce au défibrillateur cardiaque implantable (DCI). Toutefois, des préoccupations uniques face au DCI, y compris les chocs que l’appareil peut déclencher, sont susceptibles de provoquer des symptômes d'anxiété et une limitation perçue des activités chez les porteurs de DCI. Ces réactions émotives et modifications de comportement peuvent affecter l’acceptation du patient envers le DCI. Cette étude pilote randomisée avec groupe contrôle (n=15 /groupe) visait à examiner la faisabilité et l'acceptabilité d'une intervention infirmière individualisée de même que ses effets préliminaires sur l’anxiété, le fonctionnement dans les activités de la vie quotidienne et l’acceptation du DCI auprès de nouveaux porteurs de DCI. L'intervention infirmière, basée sur la théorie du Human Caring et teintée d’une approche cognitive comportementale, ciblait les préoccupations individuelles face au DCI. À partir des préoccupations identifiées, l’infirmière intervenait en mettant l'accent sur les croyances contraignantes du patient, qui pouvaient mener à de l’anxiété et des comportements d'évitement. Après randomisation, les patients du groupe intervention (GI) ont participé à un premier entretien en face-à-face avant le congé hospitalier. Subséquemment, deux entretiens se sont faits par téléphone, à environ 7 et 14 jours suite au congé hospitalier. Les résultats soutiennent la faisabilité et l’acceptabilité du devis de l’étude et de l’intervention évaluée. De plus, ils soulignent le potentiel de l’intervention à diminuer les sentiments anxieux chez les participants du GI. Les résultats de cette étude pilote offrent des pistes de recherches futures et permettront de guider la pratique clinique.