The GermAn Laser Lead Extraction RegistrY: GALLERY.

AIMS: The GermAn Laser Lead Extraction RegistrY: GALLERY is a retrospective, national multicentre registry, investigating the safety and efficacy of laser lead extraction procedures in Germany. METHODS AND RESULTS: Twenty-four German centres that are performing laser lead extraction have participated in the registry. All patients, treated with a laser lead extraction procedure between January 2013 and March 2017, were consecutively enrolled. Safety and efficacy of laser lead extraction were investigated. A total number of 2524 consecutive patients with 6117 leads were included into the registry. 5499 leads with a median lead dwell time of 96 (62-141) months were treated. The mean number of treated leads per patient was 2.18 ± 1.02. The clinical procedural success rate was 97.86% and the complete lead removal was observed in 94.85%. Additional extraction tools were used in 6.65% of cases. The rate of procedural failure was 2.14% with lead age ≥10 years being its only predictor. The overall complication rate was 4.32%, including 2.06% major and 2.26% minor complications. Procedure-related mortality was 0.55%. Female sex and the presence of abandoned leads were predictors for procedure-related complications. The all-cause in-hospital mortality was 3.56% with systemic infection being the strongest predictor, followed by age ≥75 years and chronic kidney disease. CONCLUSION: In the GALLERY, a high success- and low procedure-related complication rates have been demonstrated. In multivariate analysis, female sex and the presence of abandoned leads were predictors for procedure-related complications, while the presence of systemic infection, age ≥75 years, and chronic kidney disease were independent predictors for all-cause mortality.

Influence of a tilting prosthetic mitral valve orientation on the left ventricular flow - an experimental in vivo magnetic resonance imaging study.

OBJECTIVE: Orientation-related monoleaflet mechanical valve flow and velocity studies in the downstream are limited in mitral valve replacement studies. METHODS: In five sheep, ventricular blood flow was visualized prior to the implantation of a Medtronic Hall tilting valve model. In six sheep, the implant orientation was either anatomical (disc aligned with the anterior leaflet) or anti-anatomical. The mitral subvalvular apparatus was preserved. Sheep were positioned within an 1.5 T field strength MR scanner (Magnetom Sonata; Siemens) to assess time-dependent three dimensional blood flow. RESULTS: The preoperative ventricular velocity profiles presented negligible individual variances. Streamlines passed homogeneously without any spatial differences in flow velocities into the left ventricle. Starting from the anatomical position, blood entered mainly through the major orifice of the mechanical valve. The single artificial leaflet mimicked the rudder effect of the natural anterior mitral leaflet, preventing blood streaming directly towards the septum. The area with inhomogeneous blood velocities in the ventricle increased but not significantly from the preoperative status. The non-axial inflow not directed directly to the apex converted to a similar helix as observed in the preoperative cases. Anti-anatomical orientation of the prosthesis caused a significant increase in turbulence immediately after passing the mitral prosthesis. The main stream was changed so significantly that the blood flow shifted towards the septum and caused higher velocities of the stream profiles and turbulence apically. CONCLUSIONS: To achieve optimal hemodynamics, orientation of the mitral tilting valve has to be considered carefully, as has been long known from aortic valve replacement studies.

Clinical advantages of using mini-bypass systems in terms of blood product use, postoperative bleeding and air entrainment: an in vivo clinical perspective.

OBJECTIVE: In an effort to minimize the effect of extracorporeal circulation (ECC), mini-bypass is gaining clinical acceptance in routine coronary artery bypass grafting (CABG). These small circuits target combine the clinical advantages of reduced prime, 100% bio-coating and suction blood separation. We demonstrate that the use of mini-bypass in routine CABG reduces homologous blood product use and postoperative bleeding. Our goal was to also demonstrate that these small systems are effective in gaseous microemboli (GME) management as compared to a conventional extracorporeal system. METHODS: Prospective, randomized study comparing 30 mini-bypass (Dideco ECC.O) to 30 conventional systems (n=30, Dideco 903 Avant). Study included CABG cases only, independent of preoperative coagulative status; clinic ethical committee approval and informed patient consent was obtained before initiating study. RESULTS: There were no statistical differences in terms of patient demographics. Statistically significant differences were seen in transfusion frequency (27% of the study group vs 43% in the control group, p=0.05), transfused volume (133.3+/-244.5 ml vs 325+/-483.1 ml, p<0.05), fresh frozen plasma (0 unit vs 3 units, p<0.001), postoperative bleeding (301.8+/-531.9 ml vs 785.5+/-1000.4 ml, p<0.05) and GME activity post-arterial filter (0.14 microl vs 5.32 microl, p<0.05). CONCLUSIONS: The adoption of mini-bypass significantly potentially reduces hemodilution, donor blood usage, postoperative bleeding and exposure to GME in routine CABG patients as compared to the use of conventional extracorporeal circulation circuits.

Use of a dynamic bubble trap in the arterial line reduces microbubbles during cardiopulmonary bypass and microembolic signals in the middle cerebral artery.

Neurological complications remain an important cause of morbidity and mortality of patients following cardiopulmonary bypass (CPB). Microemboli, as well as cerebral hypoperfusion, are the main postulated mechanisms. This study demonstrates that the insertion of a dynamic bubble trap (DBT) into the curcuit reduces microbubbles in the arterial line and microembolic signals (MES) in the middle cerebral arteries (MCAs). We investigated 12 patients during coronary artery bypass grafting (CABG). The DBT was inserted between the arterial filter and the arterial cannula. For detection of microemboli before and after the DBT, a special ultrasound Doppler device was used. MES were detected by transcranial Doppler monitoring in both MCAs of the patients. Microbubbles and MES were counted during bypass. These data were compared to 12 patients who were operated in a previous period without the use of a DBT. There were no significant differences in both groups with respect to gender, age, crossclamp and bypass time and number of anastomoses. In the group without a DBT in the circuit, a mean of 6311 microbubbles per operation could be observed distal to the arterial filter, corresponding to 282 MES. After inclusion of a DBT, we could register, in the second group, 8496 microemboli proximal and 2915 distal of the DBT, corresponding to 89 MES per operation. The reduction rate of microbubbles in the tubing was 65.7%, corresponding to a reduction in MES of about 86.2%. We conclude that the insertion of a DBT in the arterial line of CPB circuit protects the cerebrovascular system from microembolic events, as demonstrated by lower MES counts.

Neuropsychological deficits after mechanical aortic valve replacement.

BACKGROUND AND AIM OF THE STUDY: Studies using transcranial Doppler monitoring have identified high-intensity transient signals (HITS) after mechanical valve replacement. Although cognitive dysfunction in relation to HITS was reported in some studies, the current data basis is inconsistent. The study aim was to investigate the long-term effects of HITS on cognitive function. METHODS: Forty patients who had undergone mechanical valve replacement (mean 5.3 years previously) participated in the study. HITS-measurements were performed on the day of neuropsychological assessment. Patients were allocated to HITS-high and HITS-low groups on the basis of the median HITS-rate. Both patient groups completed a neuropsychological test battery and were compared to healthy controls. RESULTS: Both patient groups showed verbal and visual memory deficits in comparison with controls. The HITS-high group scored lower on verbal memory compared to the HITS-low group. In addition, the HITS-high group showed executive deficits when compared to the HITS-low group and controls. The significant effects with respect to verbal memory and executive functions remained after extracorporeal circulation time differences were controlled for. CONCLUSION: The study results imply that heart valve replacement with mechanical prostheses may be associated with mild cognitive impairment. The differential impairment pattern of the high- and low-HITS groups further suggests that the number of HITS may be of critical importance. The observed memory impairments were consistent with the view that cognitive dysfunction after valve replacement may be due to temporal lobe dysfunction. However, future studies are required to investigate the association of number of HITS, cerebral changes and cognitive function in further detail.

The dynamic bubble trap reduces microbubbles in extracorporeal circulation and high intensity transient signals in the middle cerebral artery: a case report.

Microemboli during extracorporeal circulation (ECC) might be a reason for postoperative neuropsychological dysfunction. This case report shows that reduction of microbubbles in the arterial line, as well as high intensity transient signals (HITS) in the middle cerebral artery (MCA), could be accomplished by use of a dynamic bubble trap (DBT) during routine coronary artery bypass graft (CABG) surgery in a 63-year-old male. The DBT was placed after the arterial filter, an ultrasound Doppler device was used for detection of microemboli before and after the DBT. HITS were measured by a transcranial ultrasound Doppler in both MCAs. For first 32 min of ECC, the DBTwas excluded; 54 916 microbubbles and 507 HITS were counted. In the next 30 min, blood flow was directed through the DBT. This led to a significant reduction of microbubbles from 55 888 to 18 237; accordingly, only 120 HITS were registered. A DBT, integrated in ECC for routine CABG, effectively reduces air bubbles, thus protecting the cerebrovascular system from microembolization, as demonstrated by lower HITS counts.