Emilia Stegemann

Thirty-day outcome after transcatheter aortic valve implantation compared with surgical valve replacement in patients with high-risk aortic stenosis: a matched comparison.

BackgroundTranscatheter aortic valve implantation (TAVI) has become a therapeutic alternative to surgery for the treatment of severe aortic stenosis in high-surgical risk patients. The aim of this study was to compare 30-day mortality of high-risk patients treated by TAVI versus surgical aortic valve replacement. MethodsA total of 175 patients (60 men; mean age, 80±6 years; Euroscore 21±13%) having undergone TAVI were compared with 175 matched patients (76 men; mean age, 79±3 years; Euroscore 17±9%), which have undergone conventional aortic valve replacement and were deemed to be high-risk patients by the cardiothoracic surgeons. Thirty-day mortality and major adverse events were recorded in both groups. Patients’ characteristics were analyzed for predictors of mortality in the TAVI group. ResultsTwenty-one patients (12%) in the TAVI group and 13 patients (8%) in the surgical group died within 30 days of the procedure (P=0.165). Two patients (1%) in the TAVI group and one patient (0.5%) in the conventional surgery group had a major stroke (P=1.0). Seven patients (4%) in the TAVI group and 25 patients (14%) in the conventional surgery group required dialysis post procedure (P=0.0013). The average length of stay in the intensive care unit was lower in the TAVI group compared with the conventional surgical group (3.3±3.1 vs. 6.6±10.5 days; P<0.001). Age was the only independent predictor of mortality in the TAVI group (odds ratio=1.009; 95% confidence interval: 1.001–1.018 per additional year; P=0.0186) and in the total study population (odds ratio=1.007; 95% confidence interval: 1.001–1.013 per additional year; P=0.0186). ConclusionIn high-surgical risk patients, TAVI can be performed at a mortality risk comparable with conventional surgery with a reduced length of post interventional intensive care unit stay and less need for dialysis.

Characterization of the Non-Invasive Assessment of the Cutaneous Microcirculation by Laser Doppler Perfusion Scanner

Microcirculation (2010) 17, 358–366. doi: 10.1111/j.1549‐8719.2010.00037.x

Local Association Between Endothelial Dysfunction and Intimal Hyperplasia: Relevance in Peripheral Artery Disease

Background Endothelial dysfunction is a key factor in the development of atherosclerosis. Commonly, endothelial function is determined in the brachial artery, whereas patients with peripheral artery disease (PAD) present with lower limb atherosclerosis. We hypothesized that in PAD, a segmental or local association exists between endothelial dysfunction and atherosclerotic structural changes. Methods and Results We used ultrasound to study endothelial function as flow‐mediated vasodilation, intima media thickness, and local stiffness of the superficial femoral artery (SFA) and brachial artery (BA). PAD patients with symptomatic SFA or below‐the‐knee disease were compared with age‐matched patients without PAD and young healthy controls. PAD patients with SFA or below‐the‐knee disease exhibited endothelial dysfunction of the proximal SFA (flow‐mediated vasodilation: 3.9±0.6%, 3.7±0.6%) compared with healthy controls (7.4±1.0%) and patients without PAD (5.4±0.6%). Brachial artery flow‐mediated vasodilation values were not different in PAD patients with SFA or below‐the‐knee disease compared with patients without PAD, but they were significantly lower than those of healthy controls. Endothelial dysfunction correlated with increased intima media thickness or plaque thickness at the site of flow‐mediated vasodilation measurement across vascular sites. In PAD patients with SFA disease, SFA flow‐mediated vasodilation was further impaired within and distal to stenosis (prestenosis 3.9±0.6%, intrastenosis 2.3±0.7%, poststenosis 2.5±0.6%) and recovered within 24 hours after SFA balloon angioplasty to prestenotic values but not to the brachial artery or SFA values in patients without PAD or controls. Conclusion A close association exists between local endothelial function and atherosclerotic structural remodeling, suggesting that in PAD, local and segmental factors—in addition to systemic factors—influence local endothelial function. Our data point toward a pathophysiological role for lower extremity endothelial dysfunction in PAD.

Everolimus-Eluting Versus Paclitaxel-Eluting Stents for Treatment of Bare Metal Stent Restenosis

First-generation drug-eluting stents have been proved to be very effective for the treatment of bare metal stent in-stent restenosis (BMS ISR). The efficacy of second-generation drug-eluting stents in this setting remains less well defined. The present study compared the long-term clinical outcome after treatment of BMS ISR using the second-generation everolimus-eluting stent (EES) to that after treatment using the paclitaxel-eluting stent (PES). A total of 174 patients with BMS ISR underwent percutaneous coronary intervention using a PES (95 patients) or an EES (79 patients) from 2003 to 2010. The patients in the PES and EES groups were followed up for 42.2 ± 22.2 and 18.3 ± 8.2 months, respectively. The primary end point of the study was survival free of major adverse cardiac events at 1 year. The secondary end points were survival free of the need for revascularization of the target lesion and definite stent thrombosis. The baseline clinical and angiographic parameters were comparable between the 2 groups. The freedom from major adverse cardiac event rate at 1 year of follow-up was 4.5% and 13.6% (p = 0.0663) for the EES and PES groups, respectively. The target lesion revascularization (TLR) rates were greater in the PES group at 1 year of follow-up compared to the EES group (1% vs 11.5%, p = 0.0193). The rate of myocardial infarction, death, and definite stent thrombosis for the EES and PES groups at 1 year of follow-up was 0% versus 4.2% (p = 0.0984), 3% versus 2.1% (p = 0.6855), and 0% versus 2.1% (p = 0.2382), respectively. The use of a PES for treatment of ISR was the only independent predictor of recurrent TLR at 1 year of follow-up (odds ratios 1.11, 95% confidence interval 1.05 to 1.18; p = 0.0193). During the complete follow-up period, the rates of TLR, myocardial infarction, death, major adverse cardiac events, and definite stent thrombosis were not different between the 2 treatment groups. In conclusion, EES resulted in reduced rates of TLR at 1 year of follow-up compared to PES when used for treatment of BMS ISR. However, at long-term follow-up, the event rates between EES and PES were comparable after treatment of BMS ISR.

IS ENZYME RELEASE A SIGN OF IRREVERSIBLE INJURY OF CARDIOMYOCYTES

The amount of creatine kinase (CK) release (percent of releasable CK) and the amount of irreversibly injured cardiomyocytes evaluated by counting trypan blue stained nuclei (percent of total) was investigated in isolated perfused rat hearts under various conditions: Intermittent contractive depression by low calcium (0.5 mM) and by administration of BDM (10 mM) as well as by anoxia/reoxygenation. For comparison severe injury induced by calcium paradox was also studied. CK release amounted to 0.5% to 3% (controls 15 to 105 min) and to 3 to 5% for the interventions and about 40% for calcium paradox. Irreversibly injured myocytes amounted to 0.1 to 0.3% and 0.3 to 0.5% respectively and to about 40% in calcium paradox. Thus, the percentage of enzyme release exceeded the percentage of irreversibly injured cells by more than one order of magnitude under all experimental conditions, including controls, except for calcium paradox where the percentages were the same. We conclude that cytosolic enzymes can be released to substantial amounts without irreversible injury of cardiomyocytes under various conditions, and only with severe membrane lesions (Ca paradox) enzyme release reflects irreversibly injury.

Carbondioxide-Aided Angiography Decreases Contrast Volume and Preserves Kidney Function in Peripheral Vascular Interventions

Chronic kidney disease is a common comorbidity in patients with peripheral artery disease. We investigated the safety and efficacy of carbon dioxide (CO2) as supplemental contrast agent to decrease contrast volume during fluoroscopy-guided peripheral vascular procedures in routine angiological practice. We analyzed 191 consecutive interventions of the lower extremity in claudicants and critical limb ischemia (CLI) that were performed with iodinated contrast media (ICM) alone (n = 154) or with the aided or exclusive use of CO2 (n = 37). The technical success rate, total irradiation, and intervention time were not significantly different between ICM and CO2. No severe procedure-related complications occurred. The contrast volume was lower in CO2 than in ICM. Although kidney function, creatinine, and estimated glomerular filtration rate was lower in CO2 at baseline, the incidence of contrast-induced nephropathy was lower in CO2 compared to ICM. These data support CO2 as an alternative supplemental contrast agent that can be applied safely and efficiently to lower contrast volume during peripheral vascular interventions preventing kidney dysfunction even in patients with disease of the popliteal artery and below the knee and CLI.

Effect of Preinterventional Ultrasound Examination on Frequency of Procedure-Related Vascular Complications in Percutaneous Coronary Interventions With Transfemoral Approach

Vascular complications are the most frequent adverse events associated with percutaneous coronary interventions (PCIs) leading to an increase in morbidity and mortality. Puncture of the common femoral artery in its middle segment is proved to decrease the risk of procedure-related vascular complications. Real-time ultrasound-guided puncture of the vessel is effective to decrease access site-related vascular complications but complex to perform. We evaluated whether an ultrasonic preinterventional examination of the femoral puncture site and skin marking of anatomic structures and specific vascular characteristics results in a decrease of access site-related vascular complications in PCIs with transfemoral access. Over a period of 12 months we prospectively examined all puncture sites before elective PCIs with transfemoral access (n = 848) using ultrasound. Presence, extent, and location of plaques and stenoses and exact location of bifurcation of the femoral artery were marked by a sonographer on the skin to guide the interventionists in vascular puncture. Postinterventional access site ultrasound was performed to determine possible access site-related complications. Frequency of vascular access site complications was compared to a control cohort (n = 1,027) that did not undergo ultrasound examination before intervention. With ultrasonic vascular access site management the rate of access site-related vascular complications was decreased from 4.2% to 1.9% (odds ratio 0.44, 0.23 to 0.80, p = 0.005). In conclusion, preinterventional ultrasonic access site examination and skin marking decreases the risk of vascular complications in elective PCI with femoral access.

Survival and quality of life in patients with cardiac resynchronization therapy for severe heart failure and in heart transplant recipients within a contemporary heart failure management program.

BACKGROUND Current treatment of advanced chronic heart failure comprises pharmacologic approaches, multidisciplinary management strategies and device therapy. We sought to compare the outcome after cardiac synchronization therapy (CRT) with the outcome after heart transplantation within a contemporary heart failure management program. METHODS In a cohort study, survival and quality of life were assessed in 105 patients who had received CRT (53% with defibrillator) for severe heart failure and in 112 heart transplant recipients attending a heart failure clinic at a tertiary hospital. For assessment of health-related quality of life the Medical Outcome Short Form 36 (SF-36) was applied to the survivors. A propensity score for receiving transplantation vs CRT was developed using logistic regression and was incorporated into statistical models. RESULTS Severity of heart failure before heart transplantation or CRT was similar. Survival was not different between device recipients and transplant recipients by Kaplan-Meier analysis. Cox regression analysis with time-dependent covariates revealed a significant interaction between treatment and time, which favored transplantation late after intervention. There were no significant differences in 7 of 8 subjective measures of health-related quality of life. The score for physical functioning was higher in the transplantation group; this difference remained of borderline significance after multivariate adjustment. CONCLUSIONS Contemporary management of patients with advanced heart failure including CRT leads to improved survival and quality of life and diminishes the difference in these outcomes between conservative management and heart transplantation within the time-frame studied. Patient selection for heart transplantation requires consideration of these results.

Evaluation of a Structured Training Program for Arterial Femoral Sheath Removal After Percutaneous Arterial Catheter Procedures by Assistant Personnel

After cardiac catheterization procedures, arterial closure can be achieved by manual compression (MC), using external mechanical compression devices, or by applying vascular closure devices (VCDs) with comparable vascular access site-related complication rates. The aim of the present study was to assess vascular access site-related complications during the implementation of structured sheath removal and MC by paramedics after catheterization procedures. After an observational phase of 3 months to assess the baseline complication rate, a structured 4-level training program was implemented to train assistant personnel, in this case paramedics, in the management of sheath removal by MC. Access site-related complication rates after sheath removal were assessed prospectively and MC by paramedics compared with MC by physicians and application of VCDs. To account for imbalances in procedure- and patient-related risk factors of access-site complications, propensity score-based matching analysis was performed (ClinicalTrials.gov identifier NCT00825331). All consecutive percutaneous transfemoral arterial cardiac catheterization procedures were prospectively assessed over a period of 8 months (n = 3,503). MC was performed in 2,315 cases, of which 180 were performed by paramedics and 2,135 by physicians; VCDs were applied in 1,188 procedures. Rates of access site-related complications were significantly lower for paramedics compared with physicians (p = 0.03) and similar between paramedics and VCDs (p = 0.77). In conclusion a structured program for paramedics to be trained in sheath removal after percutaneous cardiac catheterization procedures can be readily implemented during clinical routine with low in-hospital complication rates.

Carbon Dioxide Angiography Is a Standard Technique to Supplement Iodinated Contrast Angiography and Can Be a Feasible Alternative.

We would like to respond to several points brought up in the letter by Dogan et al entitled ‘‘Carbon Dioxide Angiography: To be or not to be an alternative?’’ Although the authors refer to our study as a randomized trial, our study was (unfortunately) not a randomized controlled trial. Furthermore, they criticize that the frame rate should have been specified for image quality assessment. In fact, the X-ray protocol including frame rates were given (see page 3, line 21-23). Furthermore, they state that specific equipment is needed. This is only true to a certain degree. Most modern catheterization suites with digital subtraction angiography capability are equipped for CO2 angiography and basically all catheters can be used. Although an automated CO2 gas injector is certainly nice and may lead to better images, it can be quite an investment. From our perspective, all it really requires for acceptable results is a laparoscopy grade CO2 gas bottle with a pressurelowering valve, standard single-use filters, and a reservoir to hold a certain gas volume; a few hundred Euros. We use the single-use 100-mL Angioset syringes from Optimed (Angioset, Optimed Medizinische Instrumente GmbH, Ettlingen, Germany) that cost as much as a guiding catheter. However, any type of sterile vessel can be used with a 3-way valve. Dogan et al also state that ‘‘this procedure may be very painful and general anesthesia is frequently preferred.’’ We agree that pain may occur following injection causing the patient to move in response leading to less good image quality. However, in our experience, pain only occurs in a fraction of patients and some patients also experience similar pain in response to other contrast agents. We disagree that ‘‘general anesthesia is frequently preferred.’’ There may be a difference in the concept of pain in different countries. Dogan et al may like to provide references to support their claim or state their own experience in more detail. Dogan et al conclude that ‘‘CO2 angiography needs more large-scale studies before its widespread use.’’ Although this technique may not be as widely accepted or accessible in some countries, CO2 angiography is an established technique known for a long time. We argue that in most modern high-volume vascular laboratories in developed countries, this technique can be regarded as a standard technique (with all known limitations) to supplement iodinated contrast angiography. It can even be a feasible alternative for some patients who could not be treated otherwise.