Alexander Lauten

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.

Heterotopic transcatheter tricuspid valve implantation: first-in-man application of a novel approach to tricuspid regurgitation

AIMS Transcatheter treatment of heart valve disease is well established today. However, for the treatment of tricuspid regurgitation (TR), no effective catheter-based approach is available. Herein, we report the first human case description of transcatheter treatment of severe TR in a 79-year-old patient with venous congestion and associated non-cardiac diseases. In this patient, surgical treatment had been declined and pharmacological therapy had been ineffective. After ex vivo and animal studies, the treatment of TR was performed by percutaneous caval valve implantation. METHODS AND RESULTS In a transcatheter approach through the right femoral vein, a custom-made self-expanding heart valve was implanted into the inferior vena cava (IVC). The device was anchored in the IVC at the cavoatrial junction with the level of the valve aligned immediately above the hepatic inflow and protruding into the right atrium. After deployment, excellent valve function was observed resulting in a marked reduction in caval pressure and an abolition of the ventricular wave in the IVC. Sequential echocardiographic exams over a follow-up period of 8 weeks confirmed continuous device function without paravalvular leakage or remaining venous regurgitation. The patient experienced improved physical capacity and was able to resume off-bed activities. There was no recurrence of right heart failure during follow-up and a partial reduction of ascites. The patient was discharged from hospital into a rehabilitation programme. CONCLUSION Transcatheter treatment of severe TR by caval valve implantation is feasible resulting in an immediate abolition of IVC regurgitation and mid-term clinical improvement. Thus, in selected non-surgical patients, caval valve implantation may become a therapeutic option to treat venous regurgitation and improve associated non-cardiac diseases. Further confirmatory experience with longer follow-up is required to evaluate the long-term clinical benefit of the procedure as well as potential deleterious effects.

Risk Assessment of Ventricular Arrhythmias in Patients with Nonischemic Dilated Cardiomyopathy by Strain Echocardiography

BACKGROUND Indications for prophylactic implantable cardioverter-defibrillator implantation in patients with nonischemic dilated cardiomyopathy (DCM) are based on left ventricular (LV) ejection fraction (LVEF), although LVEF has limited ability to predict arrhythmias. It has recently been shown that strain echocardiography can predict ventricular arrhythmias in patients after myocardial infarction. The aim of this study was to evaluate whether strain echocardiography may help in the risk stratification of ventricular arrhythmias in patients with DCM. METHODS Ninety-four patients with nonischemic DCM were prospectively included. By speckle-tracking strain echocardiography, global longitudinal strain was calculated as the average of peak longitudinal strain from a 16-segment LV model. The time interval from electrocardiographic peak R to peak negative strain was assessed in each LV segment. Mechanical dispersion was defined as the standard deviation of time to peak negative strain from 16 LV segments. RESULTS After a median of 22 months of follow-up (range, 1-46 months), 12 patients (13%) had experienced arrhythmic events, defined as sustained ventricular tachycardia or cardiac arrest. LVEF and global longitudinal strain were reduced in patients with DCM with arrhythmic events compared with those without (28 ± 10% vs 38 ± 13%, P = .01, and -6.4 ± 3.3% vs -12.3 ± 5.2%, P < .001, respectively). Global longitudinal strain showed greater area under the curve than LVEF to identify arrhythmic events in receiver operating characteristic curve analyses (P = .05). Patients with arrhythmic events had increased mechanical dispersion (98 ± 43 vs 56 ± 18 ms, P < .001). Mechanical dispersion predicted arrhythmias independently of LVEF (hazard ratio, 1.28; 95% confidence interval, 1.11-1.49; P = .001). CONCLUSIONS Global longitudinal strain is a promising marker of arrhythmias. Mechanical dispersion predicted arrhythmic events in patients with DCM independently of LVEF. Strain echocardiography may help in the risk stratification of patients with DCM not fulfilling current implantable cardioverter-defibrillator indications.

Transcatheter Aortic Valve Implantation in Patients With Low-Flow, Low-Gradient Aortic Stenosis

OBJECTIVES The purpose of this study was to evaluate the efficacy and outcome of transcatheter aortic valve implantation (TAVI) in patients with low-flow, low-gradient aortic stenosis (LG-AS). BACKGROUND Patients with LG-AS have a poor prognosis with medical treatment and a high risk for surgical aortic valve replacement. METHODS Between January 2009 and June 2010, a total of 1,302 patients underwent TAVI for severe AS and were prospectively included in the multicenter German TAVI registry. RESULTS LG-AS was present in 149 patients (11.4%; mean age: 80.2 ± 6.3 years). In this subgroup, the EuroSCORE was significantly higher (26.8 ± 16.6 vs. 20.0 ± 13.3; p < 0.0001) compared with patients with high-gradient AS (HG-AS). The procedural success rate (LG-AS: 95.3% vs. HG-AS: 97.5%; p = 0.13) and the rate of TAVI-associated complications were comparable in both groups (new pacemaker: 27.0% vs. 28.1%; p = 0.76; cerebrovascular events: 3.4% vs. 3.1%, p = 0.83). However, post-operative low-output syndrome occurred more frequently in the LG-AS-group (LG-AS: 14.9% vs. HG-AS: 5.7%, p < 0.0001), and mortality at 30 days and 1 year was significantly higher in this subgroup (LG-AS: 12.8% and 36.9% vs. HG-AS: 7.4% and 18.1%; p < 0.001 and p < 0.0001, respectively). Post-operative New York Heart Association functional class improved, and self-assessed quality of life increased significantly, demonstrating a substantial benefit in the LG-AS group at 30 days and 1 year after TAVI. CONCLUSIONS In high-risk patients with LG-AS, TAVI is associated with a significantly higher mortality at 30 days and at 1 year. However, long-term survivors benefit from TAVI with functional improvement and a significantly increased quality of life. Therefore, in view of the poor prognosis with medical treatment, TAVI should be considered an option in high-risk patients with LG-AS.

Percutaneous Bicaval Valve Implantation for Transcatheter Treatment of Tricuspid Regurgitation Clinical Observations and 12-Month Follow-Up

Severe tricuspid regurgitation (TR) frequently constitutes a high risk for surgical correction.1 For inoperable patients with TR, transcatheter caval valve implantation has been suggested.2 Herein, we report the human application and 12-month follow-up after first bicaval implantation of self- expanding valves into the superior (SVC) and inferior (IVC) vena cava as interventional concept for severe TR.3 The procedure was performed as compassionate treatment in an 83-year-old female with severe, long-standing functional and structural TR after University Hospital Jena institutional review board approval. At admission, she was in New York Heart Association-stage IV and presented symptoms of chronic right heart failure with peripheral edema, ascites, and orthopnea. Synthetic liver function was impaired with reduced serum albumin and cholinesterase because of congestive hepatopathy, echocardiography demonstrated right ventricle enlargement with preserved systolic function. Right heart catheterization confirmed severe TR with a ventricular wave (v-wave) in the right atrium (RA), the SVC, and the IVC of 32, 27, and 28 mm Hg, respectively, as well as a slightly elevated pulmonary artery pressure and vascular resistance. Hemodynamics, laboratory, and clinical parameters are detailed in the Table. View this table: Table. Clinical and Hemodynamic Parameters Before and After Caval Valve Implantation Based on computed tomography-angiographic images, 2 self-expanding percutaneous heart valves were custom-made with 10% to 20% oversizing to fit the anticipated implantation site in the SVC and IVC.4 The IVC valve was designed with the upper segment protruding into the RA with the biological valve located above …

Percutaneous caval stent valve implantation: investigation of an interventional approach for treatment of tricuspid regurgitation

AIMS Severe tricuspid regurgitation (TR) reduces cardiac output (CO) and increases central venous pressure leading to secondary organ dysfunction. To date, the open surgical approach is the only option to treat TR. Herein, we report our experience of treatment by percutaneous implantation of valved stents in the inferior vena cava (IVC) and superior vena cava (SVC) to substitute tricuspid valve function in a model of acute insufficiency. METHODS AND RESULTS Acute TR grades III-IV was created in 13 sheep (54-75 kg) via papillary muscle and chordae avulsion using a 0.07 inch wire blade. Successful creation of TR was confirmed using angiography and by a prominent ventricular wave in central venous pressure recording. Two self-expanding nitinol stents containing a porcine pulmonary valve were then implanted in the IVC and SVC in a transcatheter approach. Implantation was performed through the right jugular vein by means of a 21 F catheter and guided by fluoroscopy. Haemodynamics were continuously monitored and valve function was verified by angiography and epicardial echocardiography. After successful implantation and proof of concept in the acute study (acute group, n = 9), chronic studies were (n = 4, 4 weeks follow-up) performed. Tricuspid regurgitation grades III-IV was successfully created in all animals and resulted in a significant reduction of CO. A ventricular wave in the IVC of 16.2 +/- 2.33 mmHg (acute group) and 14.9 +/- 1.71 mmHg (chronic group) confirmed the presence of severe TR. After deployment of the IVC and the SVC valve, the ventricular wave in the IVC significantly decreased to 13.9 +/- 2.97 mmHg (acute group) and 12.7 +/- 1.15 (chronic group), whereas CO significantly increased to 4.20 +/- 0.84 L/min (acute group) and 5.4 +/- 0.67 L/min (chronic group). At autopsy, correct device position was verified in all successfully implanted animals, no macroscopic damage resulting from the implantation procedure was observed. CONCLUSION In high-grade tricuspid insufficiency, percutaneous implantation of valved stents in the central venous position reduces venous regurgitation and improves haemodynamics in the animal experiment. Implantation of one or two valves in central venous position is technically feasible. Functional replacement of the insufficient tricuspid valve leads to an increase in CO. This technique expands the potential therapeutic options for patients with relevant tricuspid valve regurgitation having a high risk for open heart surgery.

Evaluation of the sublingual microcirculation in cardiogenic shock

OBJECTIVES Orthogonal polarized spectral imaging- and sidestream darkfield-technique have enabled visual evaluation of the microcirculation. Different investigators described microcirculatory alterations, especially in surgical patients suffering from septic shock. We investigated the sublingual microcirculation in non-surgical patients admitted to our medical, intensive care unit (ICU). METHODS In 24 severely ill (APACHE-II Score: 27.8+/-11.3), intubated patients admitted to our ICU the sublingual microcirculation was recorded with a handheld intravital microscope. Sublingual vessels were categorized according to their size (small: 10-25 microm; medium: 26-50 microm; large: 51-100 microm) and the flow in semiquantitative categories (0: no flow; 1: intermittent flow; 2: sluggish flow; 3: continuous flow). RESULTS Patients with cardiogenic shock (n=7) had lower microflow compared with patients without cardiogenic shock (small p<0.001, medium p<0.001, large p=0.003). Several other diseases, including diabetes and arterial hypertension, age, gender, had no influence. In general, patients with a flow less than 3 in the small vessels showed higher arterial blood lactate levels (p=0.043) compared to continuous flow. CONCLUSIONS A consequence of cardiogenic shock is the impairment of microcirculation with organ hypoperfusion. We observed that cardiac output is correlated to disturbance in microflow in the smallest vessels. On-line evaluation of microcirculation in vivo may be a valid tool for optimizing therapeutic measures in high risk patients. Additional online material may be found at: http://www.kim1.uniklinik-jena.de/Microcirculation.html.

Red blood cell distribution width as useful tool to predict long-term mortality in patients with chronic heart failure

Mortality and morbidity in patients with chronic heart failure (CHF) remain high. Since 2000, there was growing interest into the relationship between CHF and anemia. Low blood hemoglobin content has been identified to be highly prevalent and to be associated with poor outcome [1,2]. The etiology of anemia in patients with CHF is multifactorial, although iron deficiency was confirmed to be the most common cause [3]. Red blood cell distribution width (RDW) is a measure of the variability in size of circulating erythrocytes and is expressed as the coefficient of variation of the erythrocyte size. An elevation of RDW occurs when small or large erythrocytes are mixed with normal sized erythrocytes, in hemolytic anemia, thrombotic or inflammatory conditions, or liver disease. The study protocolwas approved by the local ethics committees, and all subjects gave written informed consent. The study was conducted in accordance with the Helsinki Declaration. The recruitment phase of the studywas conducted between 1999 and 2005 among patients with CHF admitted electively in our referral cardiology heart failure centre. The criteria for study inclusion were a documented history of CHF of ≥6 months and clinical stability. Acute coronary syndromewas defined as exclusion criterion. Patientswere seen regularly in the outpatient CHF clinics with follow-up duration ≥48 months in all survivors. Information regarding survival was obtained directly from patients or their relatives or from the CHF clinic database. The primary endpoint was allcause death or heart transplantation (HTX, whatever occurred first). Laboratory values, including RDW, were determined in the central clinical routine laboratory. RDW was measured using SE 9000 and XE 2100 (both Sysmex Corporation, Japan). Kaplan–Meier curves for cumulative survival were constructed for the different variables. Differences in event-free survival rates were tested using the Cox–Mantel log-rank test. The associations between analyzed variables and survival were established usingmultivariate Cox proportional hazards analyses. In these analyses, we included the following parameters as potential prognosticators: age, sex, BMI, NYHA class, hemoglobin, and RDW, CRP, and erythrocyte sedimentation rate (ESR). A value of pb0.05 was considered statistically significant. All statistical analyses were performed with SPSS, version 17.0 (SPSS Inc.). There were 354 patients included into the study (268 males, median age: 49 years). Fifty-nine patients were censored (lost to further follow-up). The mean follow-up was 2430 (6.6 years)± 350 days (median 2579 days, range: 1–4573 days). The proportion of uncensored patients surviving free from death or HTX was 70%. RDW median was 13.5% (25th–75th percentile: 12.9–14.5%); hemoglobin median was 9.2 mmol/l (8.4–9.9 mmol/l). In multivariate Cox proportional hazard regression models, the following variables were shown to predict increased rate of death and HTX: age (hazard ratio (HR): 1.040 (confidence interval: 1.002–1.081), pb0.041, per year), and RDW (HR: 1.527 (CI: 1.274–1.831), pb0.001, per 1.0). Sex, weight, NYHA class, hemoglobin, CRP and ESR were not significant. Considering the 50th percentile, RDW (13.5%) predicts

Survival does not improve when therapeutic hypothermia is added to post-cardiac arrest care.

BACKGROUND We investigated whether the use of therapeutic hypothermia improves the outcome after cardiac arrest (CA) under routine clinical conditions. METHOD In a retrospective study, data of CA survivors treated from 2003 to 2010 were analysed. Of these, 143 patients were treated with hypothermia at 33 ± 0.5°C for 24h according to predefined inclusion criteria, while 67 who did not fulfil these criteria received comparable therapy without hypothermia. RESULTS 210 patients were included, 143 in the hypothermia group (HG) and 67 in the normothermia group (NG). There was no significant difference in mortality between the groups; 69 (48.2%) in the HG died in the first four weeks, compared to 30 patients (44.8%) in the NG (p=0.659). Patients in the NG were older and more seriously ill, and CA occurred more often in-hospital. Binary logistic regression revealed ventricular fibrillation (p=0.044), NSE serum level < 33 ng ml⁻¹ (p<0.001), age (p=0.035) and witnessed cardiac arrest (p=0.043) as independent factors significantly improving survival after CA, whereas hypothermia was not (p=0.69). The target temperature was maintained for a significantly longer time (19.5h vs. 15.2h; p=0.003) in hypothermia patients with a favourable outcome than in those with an unfavourable outcome. CONCLUSION There was no improvement in survival rates when hypothermia was added to standard therapy in this case series, as compared to standard therapy alone. The time at target temperature may be of relevance. We need better evidence in order to expand the recommendations for hypothermia after CA.

Multidimensional ECG-based analysis of cardiac autonomic regulation predicts early AF recurrence after electrical cardioversion.

BACKGROUND Heart rate turbulence, deceleration capacity (DC), and symbolic dynamics (SD) are promising novel domains of autonomic indices representing the multidimensional qualities of autonomic heart rate dynamics. PURPOSE The aim of this study was to test the impact of these novel indices in predicting early AF recurrence within the first month after electrical cardioversion (CV). METHODS In 45 patients with AF, standard Holter recordings were commenced immediately after CV. Holter-based indices were retrospectively analyzed using computerized algorithms. The best indices were applied in a multivariate model to select the optimal combination set that correctly classified patients who developed early AF recurrence. RESULTS Early AF recurrence occurred in 25 vs 20 patients with stable sinus rhythm. The set with the highest predictive power consisted of DC, turbulence onset, VLF/P, and PTH19 as a parameter of SD. The receiver operating curve analysis applied to this optimum set produced an area under the curve of 0.86, thus correctly classifying patients with 95.0% specificity and 76.0% sensitivity. CONCLUSION The analysis of novel multidimensional Holter-based autonomic indices after CV appears of clinical value because the procedure identifies patients with high risk of early AF recurrence. Furthermore, it indicates a substantial alteration of autonomic regulation.