Interim analysis of the Reitan Catheter Pump (RCP) heart failure efficacy study: RCP improves cardiovascular and renal function in acute decompensated heart failure (ADHF)

Background: The RCP is a 14 French collapsable percutaneous cardiovascular support device positioned in the descending part of the thoracic aorta via the femoral artery. A 10 patient first in man study demonstrated device safety and significant improvement in renal function among high risk PCI patients. We now report haemodynamic and renal efficacy in patients with ADHF.Methods: Prospective non randomised study seeking to recruit 20 patients with ADHF with a need for inotropic or mechanical circulatory support with: i) EF < 30% ii)Cardiac index(CI) < 2.2 L / min / m2 Outcome measures included: 1) Cardiac index (CI) 2) Pulmonary Capillary Wedge Pressure (PCWP) 3) Urine output / serum creatinine 4) Vascular / device complications 5) 30 day mortalityResults: INTERIM ANALYSIS (n=12) The mean age of the study group was 64 years, with a mean baseline creatinine of 193 umol/L, eGFR 38 ml/min. The intended RCP treatment period was 24 hours. During RCP treatment there was a significant mean reduction of PCWP at 4 hours of 17% (25 to 21 mmHg p=0.04). Mean CI increased at 12 hours by 11%, though not reaching significance (1.78 to 1.96 L/min/m2 p=0.08). RCP insertion prompted substantial diuresis. Urine output tripled over the first 12 hours compared to baseline (55 ml/hr vs 213 ml/hr p=0.03). This was associated with significantly improved renal function, a 28% reduction in serum creatinine at 12 hours (193 to 151 umol/L p=0.003), and a increase in eGFR from 38 ml/min to 50 ml/min (p=0.0007). 2 patients previously refused cardiac transplantation were reassessed and successfully transplanted within 9 months of RCP treatment on the basis of demonstrable renal reversibility. There were no vascular or device complications. There were 2 deaths at 30 days, one from multi-organ failure and sepsis, and one from intractable heart failure - neither were device related.Conclusion: RCP support in ADHF patients was associated with improved haemodynamics, and an improvement in renal function. The Reitan Catheter Pump may have a role in providing percutaneous cardiovascular and renal support in the acutely decompensated cardiac patient, and may have a role in suggesting renal reversibility in potential cardiac transplant patients. Further data will be reported at recruitment completion.

Intraobserver and interobserver variability of ascending aorta diameter as assessed with ECG-gated MDCT: automatic versus manual measurements

Purpose: Recently morphometric measurements of the ascending aorta have been done with ECG-gated MDCT to help the development of future endovascular therapies (TCT) [1]. However, the variability of these measurements remains unknown. It will be interesting to know the impact of CAD (computer aided diagnosis) with automated segmentation of the vessel and automatic measurements of diameter on the management of ascending aorta aneurysms. Methods and Materials: Thirty patients referred for ECG-gated CT thoracic angiography (64-row CT scanner) were evaluated. Measurements of the maximum and minimum ascending aorta diameters were obtained automatically with a commercially available CAD and semi-manually by two observers separately. The CAD algorithms segment the iv-enhanced lumen of the ascending aorta into perpendicular planes along the centreline. The CAD then determines the largest and the smallest diameters. Both observers repeated the automatic measurements and the semimanual measurements during a different session at least one month after the first measurements. The Bland and Altman method was used to study the inter/intraobserver variability. A Wilcoxon signed-rank test was also used to analyse differences between observers. Results: Interobserver variability for semi-manual measurements between the first and second observers was between 1.2 to 1.0 mm for maximal and minimal diameter, respectively. Intraobserver variability of each observer ranged from 0.8 to 1.2 mm, the lowest variability being produced by the more experienced observer. CAD variability could be as low as 0.3 mm, showing that it can perform better than human observers. However, when used in nonoptimal conditions (streak artefacts from contrast in the superior vena cava or weak lumen enhancement), CAD has a variability that can be as high as 0.9 mm, reaching variability of semi-manual measurements. Furthermore, there were significant differences between both observers for maximal and minimal diameter measurements (p<0.001). There was also a significant difference between the first observer and CAD for maximal diameter measurements with the former underestimating the diameter compared to the latter (p<0.001). As for minimal diameters, they were higher when measured by the second observer than when measured by CAD (p<0.001). Neither the difference of mean minimal diameter between the first observer and CAD nor the difference of mean maximal diameter between the second observer and CAD was significant (p=0.20 and 0.06, respectively). Conclusion: CAD algorithms can lessen the variability of diameter measurements in the follow-up of ascending aorta aneurysms. Nevertheless, in non-optimal conditions, it may be necessary to correct manually the measurements. Improvements of the algorithms will help to avoid such a situation.

Ascending aorta measurements as assessed by ECG-gated multi-detector computed tomography : a pilot study to etablish normative values for transcatheters therapies

Rapport de synthèse : Mesures de l'aorte ascendante par scanner synchronisé au rythme cardiaque: une étude pilote pour établir des valeurs normatives dans le cadre des futures thérapies par transcathéter. Objectif : L'objectif de cette étude est d'établir les valeurs morphométriques normatives de l'aorte ascendante à l'aide de l'angiographie par scanner synchronisé au rythme cardiaque, afin d'aider au développement des futurs traitements par transcathéter. Matériels et méthodes : Chez soixante-dix-sept patients (âgé de 22 à 83 ans, âge moyen: 54,7 ans), une angiographie par scanner synchronisé au rythme cardiaque a été réalisée pour évaluation des vaisseaux coronaires. Les examens ont été revus afin d'étudier l'anatomie de la chambre de chasse du ventricule gauche jusqu'au tronc brachio-céphalique droit. A l'aide de programmes de reconstructions multiplanaires et de segmentation automatique, différents diamètres et longueurs considérés comme importants pour les futurs traitements par transcathéter ont été mesurés. Les valeurs sont exprimées en moyennes, médianes, maximums, minimums, écart-types et en coefficients de variation. Les variations de diamètre de l'aorte ascendante durant le cycle cardiaque ont été aussi considérées. Résultats : Le diamètre moyen de la chambre de chasse du ventricule gauche était de 20.3+/-3.4 mm. Au niveau du sinus coronaire de l'aorte, il était de 34.2+/-4.1 mm et au niveau de la jonction sinotubulaire il était de 29.7+/-3.4 mm. Le diamètre moyen de l'aorte ascendante était de 32.7+/-3.8 mm. Le coefficient de variation de ces mesures variait de 12 à 17%. La distance moyenne entre l'insertion proximale des valvules aortiques et le départ du tronc brachio-céphalique droit était de 92.6+/-11.8 mm. La distance moyenne entre l'insertion proximale des valvules aortiques et l'origine de l'artère coronaire proximale était de 12.1+/-3.7 mm avec un coefficient de variation de 31%. La distance moyenne entre les deux ostia coronaires était de 7.2+/-3.1 mm avec un coefficient de variation de 43%. La longueur moyenne du petit arc de l'aorte ascendante entre l'artère coronaire gauche et le tronc brachio-céphalique droit était de 52.9+/-9.5 mm. La longueur moyenne de la continuité fibreuse entre la valve aortique et la valvule mitrale antérieure était de 14.6+/-3.3 mm avec un coefficient de variation de 23%. L'aire moyenne de la valve aortique était de 582.0+/-131.9 mm2. La variation du diamètre antéro-postérieur et transverse de l'aorte ascendante était respectivement de 8.4% et de 7.3%. Conclusion Il existe d'importantes variations inter-individuelles dans les mesures de l'aorte ascendante avec cependant des variations intra-individuelles faibles durant le cycle cardiaque. De ce fait, une approche personnalisée pour chaque patient est recommandée dans la confection des futures endoprothèses de l'aorte ascendante. Le scanner synchronisé au rythme cardiaque jouera un rôle prépondérant dans le bilan préthérapeutique. Abstract : The aim of this study was to provide an insight into normative values of the ascending aorta in regards to novel endovascular procedures using ECG-gated multi-detector CT angiography. Seventy-seven adult patients without ascending aortic abnormalities were evaluated. Measurements at relevant levels of the aortic root and ascending aorta were obtained. Diameter variations of the ascending aorta during cardiac cycle were also considered. Mean diameters (mm) were as follows: LV outflow tract 20.3+/-3.4, coronary sinus 34.2+/-4.1, sinotubular junction 29.7+-3.4 and mid ascending aorta 32.7+/-3.8 with coefficients of variation (CV) ranging from 12 to 17%. Mean distances (mm) were: from the plane passing through the proximal insertions of the aortic valve cusps to the right brachio-cephalic artery (BCA) 92.6111.8, from the plane passing through the proximal insertions of the aortic valve cusps to the proximal coronary ostium 12.1+/-3.7, and between both coronary ostia 7.2+/-3.1, minimal arc of the ascending aorta from left coronary ostium to right BCA 52.9 X9.5, and the fibrous continuity between the aortic valve and the anterior leaflet of the mitral valve 14.óf3.3, CV 13-43%. Mean aortic valve area was 582+-131.9 mm2. The variations of the antero-posterior and transverse diameters of the ascending aorta during the cardiac cycle were 8.4% and 7.3%, respectively. Results showed large inter-individual variations in diameters and distances but with limited intra-individual variations during the cardiac cycle. A personalized approach for planning endovascular devices must be considered.

Aortic valve dysfunction and aortic dilatation in adults with coarctation of the aorta

Objectif: Déterminer la prévalence de la dysfonction de la valve aortique, de la dilatation de l'aorte proximale et des interventions au niveau de la valve aortique et de l'aorte ascendante chez les adultes avec une coarctation de l'aorte. Contexte: La dysfonction de la valve aortique et la dilatation de l'aorte proximale sont rares chez les enfants et les adolescents avec une coarctation de l'aorte. A long terme, les adultes pourraient être plus à risque de développer ce type de pathologie. Méthode: Nous avons rétrospectivement passé en revue tous les adultes avec une coarctation de l'aorte corrigée ou pas suivis au « Boston Children's Hospital » entre 2004 et 2010. Résultats: 216 adultes (56 % d'hommes) avec une coarctation ont été identifiés. L'âge médian à la dernière évaluation était de 28 (de 18 à 75) ans. Une bicuspidie aortique était présente dans 66% des cas. Au dernier contrôle, 3% avaient une sténose aortique modérée ou sévère et 4% avaient une insuffisance aortique modérée à sévère. Une dilatation de la racine de l'aorte ou de l'aorte ascendante était présente dans 28%, respectivement 42% des patients. Une dilatation au moins modérée de la racine de l'aorte ou de l'aorte ascendante (score Z > 4) était présente dans 8%, respectivement 14%. Les patients avec une bicuspidie aortique étaient plus sujets à avoir une dilatation au moins modérée de la racine de l'aorte ou de l'aorte ascendante comparés à ceux sans bicuspidie (20% contre 0%; p<0.001). L'âge était associé à une dilatation de l'aorte ascendante (p=0.04). Au dernier suivi, 6% avait nécessité une intervention au niveau de la valve aortique et 3% un remplacement de la racine de l'aorte ou de l'aorte ascendante.

Variability of ascending aorta diameter measurements as assessed with electrocardiography-gated multidetector computerized tomography and computer assisted diagnosis software.

Recently, morphometric measurements of the ascending aorta have been done with ECG-gated multidector computerized tomography (MDCT) to help the development of future novel transcatheter therapies (TCT); nevertheless, the variability of such measurements remains unknown. Thirty patients referred for ECG-gated CT thoracic angiography were evaluated. Continuous reformations of the ascending aorta, perpendicular to the centerline, were obtained automatically with a commercially available computer aided diagnosis (CAD). Then measurements of the maximal diameter were done with the CAD and manually by two observers (separately). Measurements were repeated one month later. The Bland-Altman method, Spearman coefficients, and a Wilcoxon signed-rank test were used to evaluate the variability, the correlation, and the differences between observers. The interobserver variability for maximal diameter between the two observers was up to 1.2 mm with limits of agreement [-1.5, +0.9] mm; whereas the intraobserver limits were [-1.2, +1.0] mm for the first observer and [-0.8, +0.8] mm for the second observer. The intraobserver CAD variability was 0.8 mm. The correlation was good between observers and the CAD (0.980-0.986); however, significant differences do exist (P<0.001). The maximum variability observed was 1.2 mm and should be considered in reports of measurements of the ascending aorta. The CAD is as reproducible as an experienced reader.

Transapical aortic valve replacement through a chronic apical aneurysm.

Transapical aortic valve replacement through an apical aneurysm is traditionally contraindicated because of the risk of severe systemic embolization when thrombi are present. However, a chronic fibrotic aneurysm without apical thrombi carries a low risk of distal embolization and can be safely employed for a transapical transcatheter aortic valve replacement in case of absence of an alternative access site (severe vascular disease, small vascular sizes and diseased calcified aorta). We illustrate our experience with a 73-year-old patient suffering from symptomatic aortic valve stenosis, coronary artery disease with occluded left anterior descending artery, left ventricular apical aneurysm and severe peripheral vascular disease, who successfully underwent a transapical 26 mm Sapien? XT stent-valve implantation through the fibrotic thin akinetic apical wall.

Assessment of occlusive arterial disease of abdominal aorta and lower extremities arteries : value of multidetector CT angiography using and adaptative acquisition method

Rapport de synthèse : Objectif : Le but de ce travail est d`étudier l'angiographie par scanner multi-barrette (AS) dans l'évaluation de l'artériopathie oblitérante (AOMI) de l'aorte abdominale et des membres inférieurs utilisant une méthode adaptative d'acquisition pour optimiser le rehaussement artériel en particulier pour le lit artériel distal et les artères des pieds. Matériels et méthodes : Trente-quatre patients pressentant une AOMI ont bénéficié d'une angiographie trans-cathéter (ATC) et d'une AS dans un délai inférieur ou égal à 15 jours. L'AS a été effectuée du tronc coeliaque jusqu'aux artères des pieds en une seule acquisition utilisant une haute résolution spatiale (16x0.625 mm). La vitesse de table et le temps de rotation pour chaque examen ont été choisis selon le temps de transit du produit de contraste, obtenu après un bolus test. Une quantité totale de 130 ml de contraste à 4 ml/s a été utilisée. L'analyse des images de l'AS a été effectuée par deux observateurs et les données ATC ont été interprétées de manière indépendante par deux autres observateurs. L'analyse a inclus la qualité de l'image et la détection de sténose supérieure ou égale à 50 % par patient et par segment artériel. La sensibilité et la spécificité de l'AS ont été calculées en considérant l'ATC comme examen de référence. La variabilité Interobservateur a été mesurée au moyen d'une statistique de kappa. Résultas : L'ATC a été non-conclusive dans 0.7 % des segments, tandis que l'AS était conclusive dans tous les segments. Sur l'analyse par patient, la sensibilité et la spécificité totales pour détecter une sténose significative égale ou supérieure à 50 % étaient de 100 %. L'analyse par segment a montré des sensibilités et de spécificités variant respectivement de 91 à 100 % et de 81 à 100 %. L'analyse des artères distales des pieds a révélé une sensibilité de 100 % et une spécificité de 90 %. Conclusion : L'angiographie par CT multi-barrettes utilisant cette méthode adaptative d'acquisition améliore la qualité de l'image et fournit une technique non-invasive et fiable pour évaluer L'AOMI, y compris les artères distales des pieds.

Fish oil after abdominal aorta aneurysm surgery

OBJECTIVE: Fish oil (FO) may attenuate the inflammatory response after major surgery such as abdominal aortic aneurysm (AAA) surgery. We aimed at evaluating the clinical impact and safety aspects of a FO containing parenteral nutrition (PN) after AAA surgery. METHODS: Intervention consisted in 4 days of either standard (STD: Lipofundin medium-chain triglyceride (MCT): long-chain triglyceride (LCT)50%-MCT50%) or FO containing PN (FO: Lipoplus: LCT40%-MCT50%-FO10%). Energy target were set at 1.3 times the preoperative resting energy expenditure by indirect calorimetry. Blood sampling on days 0, 2, 3 and 4. Glucose turnover by the (2)H(2)-glucose method. Muscle microdialysis. Clinical data: maximal daily T degrees, intensive care unit (ICU) and hospital stay. RESULTS: Both solutions were clinically well tolerated, without any differences in laboratory safety parameters, inflammatory, metabolic data, or in organ failures. Plasma tocopherol increased similarly; with FO, docosahexaenoic and eicosapentaenoic acid increased significantly by day 4 versus baseline or STD. To increased postoperatively, with a trend to lower values in FO group (P=0.09). After FO, a trend toward shorter ICU stay (1.6+/-0.4 versus 2.3+/-0.4), and hospital stay (9.9+/-2.4 versus 11.3+/-2.7 days: P=0.19) was observed. CONCLUSIONS: Both lipid emulsions were well tolerated. FO-PN enhanced the plasma n-3 polyunsaturated fatty acid content, and was associated with trends to lower body temperature and shorter length of stay.

Type A quadricuspid aortic valve and ascending aorta aneurysm: a rare combination.

Quadricuspid aortic valve (QAV) is a rare congenital anomaly associated with aortic valve insufficiency and significant morbidity, and requires the replacement or, rarely, the repair of the malfunctioning heart valve. A QAV associated with an ascending aorta aneurysm is an extremely rare anatomic combination with a hypothetical, but not clear, shared embryological etiology. To date, only two cases of type B QAV with ascending aorta aneurysm have been reported. Herein is described the first ever case of a 38-year-old male suffering from severe symptomatic aortic valve regurgitation due to a type A QAV, associated with an ascending aorta aneurism, who underwent a successful combined replacement of the aortic valve and ascending aorta.

Aortic valve dysfunction and aortic dilation in adults with coarctation of the aorta.

OBJECTIVES: To determine the prevalence of aortic valve dysfunction, aortic dilation, and aortic valve and ascending aortic intervention in adults with coarctation of the aorta (CoA). BACKGROUND: Aortic valve dysfunction and aortic dilation are rare among children and adolescents with CoA. With longer follow-up, adults may be more likely to have progressive disease. METHODS: We retrospectively reviewed all adults with CoA, repaired or unrepaired, seen at our center between 2004 and 2010. RESULTS: Two hundred sixteen adults (56.0% male) with CoA were identified. Median age at last evaluation was 28.3 (range 18.0 to 75.3) years. Bicuspid aortic valve (BAV) was present in 65.7%. At last follow-up, 3.2% had moderate or severe aortic stenosis, and 3.7% had moderate or severe aortic regurgitation. Dilation of the aortic root or ascending aorta was present in 28.0% and 41.6% of patients, respectively. Moderate or severe aortic root or ascending aortic dilation (z-score > 4) was present in 8.2% and 13.7%, respectively. Patients with BAV were more likely to have moderate or severe ascending aortic dilation compared with those without BAV (19.5% vs. 0%; P < 0.001). Age was associated with ascending aortic dilation (P = 0.04). At most recent follow-up, 5.6% had undergone aortic valve intervention, and 3.2% had aortic root or ascending aortic replacement. CONCLUSION: In adults with CoA, significant aortic valve dysfunction and interventions during early adulthood were uncommon. However, aortic dilation was prevalent, especially of the ascending aorta, in patients with BAV.

How to manage the left subclavian artery during endovascular stenting of the thoracic aorta.

We performed a systematic review of the literature to establish whether revascularisation of the left subclavian territory is necessary when this artery is covered by a stent. We retrieved data from 99 studies incorporating 4906 patients. Incidences of left-arm ischaemia (0.0% vs 9.2%, p=0.002) and stroke (4.7% vs 7.2%, p<0.001) were significantly less following revascularisation, although mortality (10.5% vs 3.4%, p=0.032) and endoleak incidence (25.8% vs 12.6%, p=0.008) were increased. No significant differences in spinal-cord ischaemia were seen. Revascularisation may reduce downstream ischaemic complications but can cause significant risk. Indications must be carefully considered on an individual patient basis.

Aortobronchial and aortoesophageal fistulae as risk factors in surgery of descending thoracic aortic aneurysms.

OBJECTIVE: Assess outcome of patients with descending thoracic aortic aneurysms complicated by aortobronchial and aortoesophageal fistulae in comparison to patients undergoing repair of aortic aneurysms without fistulae. METHODS: In a consecutive series of 145 patients (age 60 +/- 12 years) with repair of descending thoracic and thoracoabdominal aortic aneurysms, 11 patients (8%; age 63 +/- 9; NS) primarily presented for hematemesis and/or hemoptysis. In 8/11 patients (73%) an aortobronchial fistula was identified, and 3/11 patients (27%) suffered from an aortoesophageal fistula. Five of 11 patients (45%) had undergone previous aortic surgery in the same region. RESULTS: Extent of aortic segments (range 1-8) replaced was 3.1 +/- 1.4 for all versus 2.6 +/- 0.9 for fistulae (NS). Aortic cross clamp time was 38 +/- 22 min for all versus 45 +/- 15 min for fistulae (NS). Mortality at 30 days was 18/145 (12%) for all versus 16/134 (12%) without fistulae versus 2/11 (18%) with fistulae (NS). Paraparesis and or paraplegia was observed in 11/145 (8%) for all versus 10/134 (7%) without fistulae versus 1/11 (9%) for cases with fistulae (NS). Nine additional patients died after hospital discharge, seven without fistulae and two with fistulae (days 80, and 120) bringing the 1-year mortality up to 23/134 (17%) without fistulae versus 4/11 (36%) with fistulae (NS). Further analysis shows that the 1-year mortality accounts for 1/8 patients (13%) with aorto-bronchial fistulae versus to 3/3 patients (100%) with aorto-esophageal fistulae (esophageal versus bronchial fistula: P = 0.018; esophageal versus no fistula: P = 0.006). CONCLUSIONS: Outcome of patients suffering from descending thoracic aortic aneurysms complicated by aorto-bronchial fistulae can be similar to that without fistulae, whereas for cases complicated by aorto-esophageal fistulae the prognosis seems to remain poor even after successful hospital discharge.