Percutaneous left-ventricular support with the Impella-2.5-assist device in acute cardiogenic shock: results of the Impella-EUROSHOCK-registry

BACKGROUND Acute cardiogenic shock after myocardial infarction is associated with high in-hospital mortality attributable to persisting low-cardiac output. The Impella-EUROSHOCK-registry evaluates the safety and efficacy of the Impella-2.5-percutaneous left-ventricular assist device in patients with cardiogenic shock after acute myocardial infarction. METHODS AND RESULTS This multicenter registry retrospectively included 120 patients (63.6±12.2 years; 81.7% male) with cardiogenic shock from acute myocardial infarction receiving temporary circulatory support with the Impella-2.5-percutaneous left-ventricular assist device. The primary end point evaluated mortality at 30 days. The secondary end point analyzed the change of plasma lactate after the institution of hemodynamic support, and the rate of early major adverse cardiac and cerebrovascular events as well as long-term survival. Thirty-day mortality was 64.2% in the study population. After Impella-2.5-percutaneous left-ventricular assist device implantation, lactate levels decreased from 5.8±5.0 mmol/L to 4.7±5.4 mmol/L (P=0.28) and 2.5±2.6 mmol/L (P=0.023) at 24 and 48 hours, respectively. Early major adverse cardiac and cerebrovascular events were reported in 18 (15%) patients. Major bleeding at the vascular access site, hemolysis, and pericardial tamponade occurred in 34 (28.6%), 9 (7.5%), and 2 (1.7%) patients, respectively. The parameters of age >65 and lactate level >3.8 mmol/L at admission were identified as predictors of 30-day mortality. After 317±526 days of follow-up, survival was 28.3%. CONCLUSIONS In patients with acute cardiogenic shock from acute myocardial infarction, Impella 2.5-treatment is feasible and results in a reduction of lactate levels, suggesting improved organ perfusion. However, 30-day mortality remains high in these patients. This likely reflects the last-resort character of Impella-2.5-application in selected patients with a poor hemodynamic profile and a greater imminent risk of death. Carefully conducted randomized controlled trials are necessary to evaluate the efficacy of Impella-2.5-support in this high-risk patient group.

Minimal-invasive percutaneous reduction and transsacral screw fixation for U-shaped fractures

STUDY DESIGN Technical note and case series. OBJECTIVE To introduce an innovative minimal-invasive surgical procedure reducing surgery time and blood loss in management of U-shaped sacrum fractures. SUMMARY OF BACKGROUND Despite their seldom appearance, U-shaped fractures can cause severe neurological deficits and surgical management difficulties. According to the nature of the injury normally occurring in multi-injured patients after a fall from height, a jump, or road traffic accident, U-shaped fractures create a spinopelvic dissociation and hence are highly unstable. In the past, time-consuming open procedures like large posterior constructs or shortening osteotomies with or without decompression were the method of choice, sacrificing spinal mobility. Insufficient restoration of sacrococcygeal angle and pelvic incidence with conventional techniques may have adverse long-term effects in these patients. METHODS In a consecutive series of 3 patients, percutaneous reduction of the fracture with Schanz pins inserted in either the pedicles of L5 or the S1 body and the posterior superior iliac crest was achieved. The Schanz pins act as lever, allowing a good manipulation of the fracture. The reduction is secured by a temporary external fixator to permit optimal restoration of pelvic incidence and sacral kyphosis. Insertion of 2 transsacral screws allow fixation of the restored spinopelvic alignment. RESULTS Anatomic alignment of the sacrum was possible in each case. Surgery time ranged from 90 to 155 minutes and the blood loss was <50 mL in all 3 cases. Two patients had very good results in the long term regarding maintenance of pelvic incidence and sacrococcygeal angle. One patient with previous cauda equina decompression had loss of correction after 6 months. CONCLUSIONS Percutaneous reduction and transsacral screw fixation offers a less invasive method for treating U-shaped fractures. This can be advantageous in treatment of patients with multiple injuries.

Ureteroileal Strictures After Urinary Diversion with an Ileal Segment—Is There a Place for Endourological Treatment at All?

Purpose We compared the long-term results of minimally invasive endourological intervention and open surgical revision in patients with a nonmalignant ureteroileal stricture. Materials and Methods We retrospectively evaluated the records of 74 patients (85 renal units) treated for unilateral or bilateral nonmalignant ureteroileal strictures. Overall, 96 endourological and 35 open surgical procedures were performed. Balloon dilatation and Acucise® or Ho:YAG laser endoureterotomy were used as minimally invasive endourological interventions. Open surgical revision with stricture resection and open ureteroileal end-to-side-reanastomosis was the alternate therapy. Treatment success was defined as radiological normalization or improvement of upper urinary tract morphology combined with absent flank pain, infection, ureteral stents or percutaneous nephrostomies. Results Median followup was 29 months (range 2 to 177). The overall success rate was 26% (25 of 96 cases) for endourological intervention vs 91% (32 of 35) for open surgical revision (p <0.001). Subgroup analysis showed a significant difference in the success rate of minimally invasive endourological interventions vs open surgical revision for strictures greater than 1 cm (3 of 52 cases or 6% vs 19 of 22 or 86%, p <0.001). The success rate of endourological and open surgical procedures for strictures 1 cm or less was 50% (22 of 44 cases) and 100% (13 of 13), respectively. After adjusting for multiple preoperative stricture characteristics, only stricture length was strongly and inversely associated with a successful outcome (p <0.001). Conclusions Open surgical revision produces better results than minimally invasive endourological intervention for ureteroileal strictures, particularly those greater than 1 cm. The success rate of endourological intervention is acceptable only for ureteroileal strictures 1 cm or less. Therefore, ureteroileal strictures greater than 1 cm should be primarily managed by open surgical revision.

Monitoring cerebral oxygenation during balloon occlusion with multichannel NIRS

We report on oxygenation changes noninvasively recorded by multichannel continuous-wave near infrared spectroscopy (CW-NIRS) during endovascular neuroradiologic interventions requiring temporary balloon occlusion of arteries supplying the cerebral circulation. Digital subtraction angiography (DSA) provides reference data on the site, timing, and effectiveness of the flow stagnation as well as on the amount and direction of collateral circulation. This setting allows us to relate CW-NIRS findings to brain specific perfusion changes. We focused our analysis on the transition from normal perfusion to vessel occlusion, i.e., before hypoxia becomes clinically apparent. The localization of the maximal response correlated either with the core (occlusion of the middle cerebral artery) or with the watershed areas (occlusion of the internal carotid artery) of the respective vascular territories. In one patient with clinically and angiographically confirmed insufficient collateral flow during carotid artery occlusion, the total hemoglobin concentration became significantly asymmetric, with decreased values in the ipsilateral watershed area and contralaterally increased values. Multichannel CW-NIRS monitoring might serve as an objective and early predictive marker of critical perfusion changes during interventions-to prevent hypoxic damage of the brain. It also might provide valuable human reference data on oxygenation changes as they typically occur during acute stroke.

Localized amyloid light-chain amyloidosis and extramedullary plasmacytoma of the mitral valve

An unusual case of localized amyloid light-chain (AL) amyloidosis and extramedullary plasmacytoma of the mitral valve is described. The worsening of a mitral regurgitation led to investigations and surgery. The valve presented marked distortion and thickening by type AL amyloid associated with a monotypic CD138+ immunoglobulin lambda plasma cell proliferation. Systemic staging showed a normal bone marrow and no evidence of amyloid deposition in other localizations. The patient's outcome after mitral valve replacement was excellent. To our knowledge, this is the first description of a localized AL amyloidosis as well as of a primary extramedullary plasmacytoma of the mitral valve.

Clinical outcome of patients with stable ischaemic heart disease as compared to those with acute coronary syndromes after percutaneous coronary intervention

Aims: To compare clinical outcomes after percutaneous coronary intervention (PCI) between patients with acute coronary syndromes (ACS) and those with stable ischaemic heart disease (SIHD) stratified by anatomic disease complexity (SYNTAX score). Methods and results: Patient-level data from three all-comers PCI trials were pooled. Patients (n=4,204) were stratified by clinical presentation (i.e., ACS or SIHD) and by SYNTAX score (i.e., lowest vs. two highest tertiles). The major adverse cardiac event (MACE) rates of patients with low-risk SIHD (n=531) and high-risk SIHD (n=1,066) were compared with ACS patients (n=2,607), respectively. At two years, the risk of MACE was higher for high-risk SIHD patients (OR 1.34, 95% CI: 1.08-1.66) and lower for low-risk SIHD patients (OR 0.61, 95% CI: 0.43-0.87) compared with ACS patients, respectively. This difference between high-risk SIHD patients and ACS patients was primarily driven by a higher risk of myocardial infarction (OR 1.64, 95% CI: 1.21-2.21), while there was no difference for cardiac death (OR 0.77, 95% CI: 0.49-1.21) or target lesion revascularisation (OR 1.21, 95% CI: 0.91-1.62). Conclusions: In this pooled analysis, the majority of patients undergoing PCI for SIHD (i.e., with SYNTAX score >8) had a higher risk of MACE than patients with ACS. Trial registration: URL: http://www.ClinicalTrials.gov; unique identifier: NCT00297661 (Sirtax), NCT00389220 (Leaders), NCT00114972 (Resolute-AC).

Real-life results of balloon kyphoplasty for vertebral compression fractures from the SWISSspine registry

BACKGROUND CONTEXT The Swiss Federal Office of Public Health mandated a nationwide health technology assessment-registry for balloon kyphoplasty (BKP) for decision making on reimbursement of these interventions. The early results of the registry led to a permanent coverage of BKP by basic health insurance. The documentation was continued for further evidence generation. PURPOSE This analysis reports on the 1 year results of patients after BKP treatment. STUDY DESIGN Prospective multicenter observational case series. PATIENT SAMPLE The data on 625 cases with 819 treated vertebrae were documented from March 2005 to May 2012. OUTCOME MEASURES Surgeon-administered outcome instruments were primary intervention form for BKP and the follow-up form; patient self-reported measures were EuroQol-5D questionnaire, North American Spine Society outcome instrument /Core Outcome Measures Index (including visual analog scale), and a comorbidity questionnaire. Outcome measures were back pain, medication, quality of life (QoL), cement extrusions, and new fractures within the first postoperative year. METHODS Data were recorded preoperatively and at 3 to 6-month and 1-year follow-ups. Wilcoxon signed-rank test was used for comparison of pre- with postoperative measurements. Multivariate logistic regression was used to identify factors with a significant influence on the outcome. RESULTS Seventy percent of patients were women with mean age of 71 years (range, 18-91 years); mean age of men was 65 years (range, 15-93 years). Significant and clinically relevant reduction of back pain, improvement of QoL, and reduction of pain killer consumption was seen within the first postoperative year. Preoperative back pain decreased from 69.3 to 29.0 at 3 to 6-month and remained unchanged at 1-year follow-ups. Consequently, QoL improved from 0.23 to 0.71 and 0.75 at the same follow-up intervals. The overall vertebra-based cement extrusion rates with and without extrusions into intervertebral discs were 22.1% and 15.3%, respectively. Symptomatic cement extrusions with radiculopathy were five (0.8%). A new vertebral fracture within a year from the BKP surgery was observed in 18.4% of the patients. CONCLUSIONS The results of the largest observational study for BKP so far are consistent with published randomized trials and systematic reviews. In this routine health care setting, BKP is safe and effective in reducing pain, improving QoL, and lowering pain_killer consumption and has an acceptable rate of cement extrusions. Postoperative outcome results show clear and significant clinical improvement at early follow-up that remain stable during the first postoperative year.

Intra- and postoperative complications of navigated and conventional techniques in percutaneous iliosacral screw fixation after pelvic fractures: Results from the German Pelvic Trauma Registry

Background: Percutaneous iliosacral screw placement following pelvic trauma is a very demanding technique involving a high rate of screw malpositions possibly associated with the risk of neurological damage or inadequate stability. In the conventional technique, the screw’s correct entry point and the small target corridor for the iliosacral screw may be difficult to visualise using an image intensifier. 2D and 3D navigation techniques may therefore be helpful tools. The aim of this multicentre study was to evaluate the intra- and postoperative complications after percutaneous screw implantation by classifying the fractures using data from a prospective pelvic trauma registry. The a priori hypothesis was that the navigation techniques have lower rates of intraoperative and postoperative complications. Methods: This study is based on data from the prospective pelvic trauma registry introduced by the German Society of Traumatology and the German Section of the AO/ASIF International in 1991. The registry provides data on all patients with pelvic fractures treated between July 2008 and June 2011 at any one of the 23 Level I trauma centres contributing to the registry. Results: A total of 2615 patients were identified. Out of these a further analysis was performed in 597 patients suffering injuries of the SI joint (187 � with surgical interventions) and 597 patients with sacral fractures (334 � with surgical interventions). The rate of intraoperative complications was not significantly different, with 10/114 patients undergoing navigated techniques (8.8%) and 14/239 patients in the conventional group (5.9%) for percutaneous screw implantation (p = 0.4242). Postoperative complications were analysed in 30/114 patients in the navigated group (26.3%) and in 70/239 patients (29.3%) in the conventional group (p = 0.6542). Patients who underwent no surgery had with 66/197 cases (33.5%) a relatively high rate of complications during their hospital stay. The rate of surgically-treated fractures was higher in the group with more unstable Type-C fractures, but the fracture classification had no significant influence on the rate of complications. Discussion: In this prospective multicentre study, the 2D/3D navigation techniques revealed similar results for the rate of intraoperative and postoperative complications compared to the conventional technique. The rate of neurological complications was significantly higher in the navigated group.

The effectiveness of a needleless intravenous system in prevention of percutaneous injury in two hospitals

This study assessed if hospital-wide implementation of a needleless intravenous connection system reduces the number of reported percutaneous injuries, overall and those specifically due to intravenous connection activities.^ Incidence rates were compared before and after hospital-wide implementation of a needleless intravenous system at two hospitals, a full service general hospital and a pediatric hospital. The years 1989-1991 were designated as pre-implementation and 1993 was designated as post-implementation. Data from 1992 were not included in the effectiveness evaluation to allow employees to become familiar with use of the new device. The two hospitals showed rate ratios of 1.37 (95% CI = 1.22-1.54, p $\le$.0001) and 1.63 (95% CI = 1.34-1.97, p $\le$.0001), or a 27.1% and a 38.6% reduction in overall injury rate, respectively. Rate ratios for intravenous connection injuries were 2.67 (95% CI = 1.89-3.78, p $\le$.0001) and 3.35 (95% CI = 1.87-6.02, p $\le$.0001), or a 62.5% and a 69.9% reduction in injury rate, respectively. Rate ratios for all non-intravenous connection injuries were calculated to control for factors other than device implementation that may have been operating to reduce the injury rate. These rate ratios were lower, 1.21 and 1.44, demonstrating the magnitude of injury reduction due to factors other than device implementation. It was concluded that the device was effective in reduction of numbers of reported percutaneous injuries.^ Use-effectiveness of the system was also assessed by a survey of randomly selected device users to determine satisfaction with the device, frequency of use and barriers to use. Four hundred seventy-eight surveys were returned for a response rate of 50.9%. Approximately 94% of respondents at both hospitals expressed satisfaction with the needleless system and recommended continued use. The survey also revealed that even though over 50% of respondents report using the device "always" or "most of the time" for intravenous medication administration, flushing lines, and connecting secondary intravenous lines, needles were still being used for these same activities. Compatibility, accessibility and other technical problems were reported as reasons for using needles for these activities. These problems must be addressed, by both manufacturers and users, before the needleless system will be effective in prevention of all intravenous connection injuries. ^

In Vitro Testing of a Temporary Catheter-Based Aortic "Parachute" Valve

Recently developed technologies allow aortic valve implantation off-pump in a beating heart. In this procedure, the native, stenotic aortic valve is not removed, but simply crushed by a pressure balloon mounted on a percutaneous catheter. Removal of the native aortic cusps before valve replacement may reduce the incidence of annular or cuspal calcium embolization and late perivalvular leaks and increase implantable valve size. However, a temporary valve system in the ascending aorta may be necessary to maintain hemodynamic stability by reducing acute aortic regurgitation and left ventricular volume overload. This study evaluates the hemodynamic effects of a wire-mounted, monoleaflet, temporary valve apparatus in a mechanical cardiovascular simulator. Aortic flow, systemic pressure and left ventricular pressure were continuously monitored. An intraluminal camera obtained real-time proximal and distal images of the valve in operation. Insertion of the parachute valve in the simulator increased diastolic pressure from 7 to 38 mm Hg. Cardiac output increased from 2.08 to 4.66 L/min and regurgitant volume decreased from 65 to 23 mL. In conclusion, placement of a temporary valve in the ascending aorta may help maintain hemodynamic stability and improve off-pump aortic valve replacement.

Early recoil after balloon angioplasty of tibial artery obstructions in patients with critical limb ischemia.

PURPOSE To assess the extent of early recoil in patients with critical limb ischemia (CLI) undergoing conventional tibial balloon angioplasty. METHODS Our hypothesis was that early recoil, defined as lumen compromise >10%, is frequent and accounts for considerable luminal narrowing after tibial angioplasty, promoting restenosis. To test this theory, 30 consecutive CLI patients (18 men; mean age 76.2±12.1 years) were angiographically evaluated immediately after tibial balloon angioplasty and 15 minutes later. Half the patients were diabetics. Target lesions included anterior and posterior tibial arteries and the peroneal artery with / without the tibioperoneal trunk. Mean tibial lesion length was 83.8 mm. Early elastic recoil was determined on the basis of minimal lumen diameter (MLD) measurements at baseline (MLDbaseline), immediately after tibial balloon angioplasty (MLDpostdilation), and 15 minutes thereafter (MLD15min). RESULTS Elastic recoil was observed in 29 (97%) patients with a mean luminal compromise of 29% according to MLD measurements (MLDbaseline 0.23 mm, MLD postdilation 2.0 mm, and MLD15min 1.47 mm). CONCLUSION Early recoil is frequently observed in CLI patients undergoing tibial angioplasty and may significantly contribute to restenosis. These findings support the role of dedicated mechanical scaffolding approaches for the prevention of restenosis in tibial arteries.

The MI SYNTAX score for risk stratification in patients undergoing primary percutaneous coronary intervention for treatment of acute myocardial infarction: A substudy of the COMFORTABLE AMI trial.

BACKGROUND To investigate the performance of the MI Sxscore in a multicentre randomised trial of patients undergoing primary percutaneous coronary intervention (PPCI). METHODS AND RESULTS The MI Sxscore was prospectively determined among 1132 STEMI patients enrolled into the COMFORTABLE AMI trial, which randomised patients to treatment with bare-metal (BMS) or biolimus-eluting (BES) stents. Patient- (death, myocardial infarction, any revascularisation) and device-oriented (cardiac death, target-vessel MI, target lesion revascularisation) major adverse cardiac events (MACEs) were compared across MI Sxscore tertiles and according to stent type. The median MI SXscore was 14 (IQR: 9-21). Patients were divided into tertiles of Sxscorelow (≤10), Sxscoreintermediate (11-18) and Sxscorehigh (≥19). At 1year, patient-oriented MACE occurred in 15% of the Sxscorehigh, 9% of the Sxscoreintermediate and 5% of the Sxscorelow tertiles (p<0.001), whereas device-oriented MACE occurred in 8% of the Sxscorehigh, 6% of the Sxscoreintermediate and 4% of the Sxscorelow tertiles (p=0.03). Addition of the MI Sxscore to the TIMI risk score improved prediction of patient- (c-statistic value increase from 0.63 to 0.69) and device-oriented MACEs (c-statistic value increase from 0.65 to 0.70). Differences in the risk for device-oriented MACE between BMS and BES were evident among Sxscorehigh (13% vs. 4% HR 0.33 (0.15-0.74), p=0.007 rather than those in Sxscorelow: 4% vs. 3% HR 0.68 (0.24-1.97), p=0.48) tertiles. CONCLUSIONS The MI Sxscore allows risk stratification of patient- and device-oriented MACEs among patients undergoing PPCI. The addition of the MI Sxscore to the TIMI risk score is of incremental prognostic value among patients undergoing PPCI for treatment of STEMI.