Martin Horack

Aortic regurgitation after transcatheter aortic valve implantation: incidence and early outcome. Results from the German transcatheter aortic valve interventions registry

Background Significant aortic regurgitation (AR) is rare following surgical aortic valve replacement and has been associated with worse outcome. Following transcatheter aortic valve implantation (TAVI), AR is common, but little is known about its determinants and its effect on clinical outcome. Objective To evaluate early outcome and risk factors possibly associated with AR after TAVI. Methods Data were analysed from 690 patients with severe aortic stenosis treated with TAVI enrolled in the prospective multicentre German transcatheter aortic valve interventions registry. The occurrence of AR was evaluated angiographically after device deployment and removal of the catheter and guidewire. Significant AR was defined as AR≥2/4. Results The study populations mean age was 81.4±6.3 years and men represented 44%. The mean logistic Euroscore was 20.4±13.1%. Overall, 84% of patients received the Medtronic CoreValve system and 16% received the Edwards Sapien valve. Significant AR occurred in 119 patients (17.2%). Factors independently associated with significant AR were aortic valve area (adjusted OR=0.10), annulus measurement by transoesophageal echocardiography (adjusted OR=1.94), male gender (adjusted OR=1.80), cardiogenic shock (adjusted OR=1.94) and renal failure (adjusted OR=0.53). In-hospital death rates were significantly higher in patients with significant AR than in those with no/mild AR (15.1% vs 6.7%, OR=2.50, 95% CI 1.37 to 4.55), as were rates of low cardiac output (20% vs 4.4%) and respiratory failure (16.5% vs 7.1%). Using multivariate analysis, the presence of post-procedural AR≥2/4 remained a strong independent predictor of in-hospital death (adjusted OR=2.43, 95% CI 1.22 to 4.85). Conclusion Significant AR after TAVI is common and is associated with increased in-hospital mortality. Long-term follow-up is critical to further define the impact of residual AR on clinical outcome. Until these data become available, every effort should be made to prevent and treat this complication.

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.

The impact of peripheral arterial disease on early outcome after transcatheter aortic valve implantation: Results From the German Transcatheter Aortic Valve Interventions Registry

BACKGROUND A significant proportion of patients undergoing transcatheter aortic valve implantation (TAVI) have concomitant peripheral arterial disease (PAD), which plays a crucial role in the preinterventional selection process of determining an optimal vascular access site. The aim of our study was to determine the impact of PAD on clinical outcome after TAVI in a real-world setting. METHODS A total of 1,315 patients (mean logistic European System for Cardiac Operative Risk Evaluation 20.6% ± 13.7%) underwent TAVI in 27 centers and were included in the prospective German TAVI Registry. RESULTS Of the 1,315 patients with TAVI, 330 (25.1%) had PAD. These patients had a higher logistic European System for Cardiac Operative Risk Evaluation score (27.7% ± 16.0% vs 18.3% ± 12.0%, P < .0001), mainly attributed to more frequent and severe comorbidities. Compared with patients without PAD, patients with PAD had a higher rate of vascular complications (28.5% vs 20.7%, P < .01), dialysis-dependent renal failure (11.2% vs 5.4%, P < .001), myocardial infarction (1.2% vs 0.3%, P < .05), and, subsequently, 30-day mortality (12.7% vs 6.9%, P < .001). Choosing a surgical approach, for example, transapical access, did not reduce the periprocedural risk associated with PAD; in-hospital mortality was 15.7% for surgical and 10.5% for percutaneous patients with TAVI having PAD (P < .001). In a multivariate regression analysis, PAD was an independent predictor of 30-day mortality (hazard ratio 1.8, 95% CI 1.2-2.7, P = .004) after TAVI. CONCLUSIONS In this real-world TAVI Registry, PAD was an independent predictor of mortality in patients with percutaneous and surgical TAVI, including vascular complications. Assessment of PAD should play a crucial role in the preinterventional selection process, regardless of the access strategy.

Incidence and predictors of permanent pacemaker implantation following transcatheter aortic valve implantation: Analysis from the german transcatheter aortic valve interventions registry

To determine predictors of permanent pacemaker (PPM) implantation up to 30 days after transcatheter aortic valve implantation (TAVI) in a prospective multicenter registry.

Ablation of atrioventricular nodal reentrant tachycardia in the elderly: results from the German Ablation Registry

BACKGROUND Catheter ablation (CA) is considered the treatment of choice for patients with atrioventricular nodal reentrant tachycardia (AVNRT). However, there is a tendency to avoid CA in the elderly because of a presumed increased risk of periprocedural atrioventricular (AV) nodal block. OBJECTIVE The purpose of this prospective registry was to assess age-related differences in the efficacy and safety of CA within a large population with AVNRT. METHODS A total of 3,234 consecutive patients from 48 German trial centers who underwent CA of AVNRT between March 2007 and May 2010 were enrolled in this study. The cohort was divided into three age groups: <50 years (group 1, n = 1,268 [39.2%]; median age = 40 [30.0-45.0] years, 74.1% women), 50-75 years old (group 2, n = 1,707 [52.8%]; 63.0 [58.0-69.0] years, 63.0% women), and > 75 years old (group 3, n = 259 [8.0%]; 79.0 [77.0-82.0] years, 50.6% women). RESULTS CA was performed with radiofrequency current (RFC) in 97.7% and cryoablation technology in 2.3% of all cases. No differences were observed among the three groups with regard to primary CA success rate (98.7% vs. 98.8 % vs. 98.5%; P = .92) and overall procedure duration (75.0 minutes [50.0-105.0]; P = .93). Hemodynamically stable pericardial effusion occurred in five group 2 (0.3%) and two group 3 (0.8%) patients but in none of the group 1 (P <.05) patients. Complete AV block requiring permanent pacemaker implantation occurred in two patients in group 1 (0.2%) and six patients in group 2 (0.4%) but none in group 3 (P = 0.41). During a median follow-up period of 511.5 days (396.0-771.0), AVNRT recurrence occurred in 5.7% of all patients. Patients >75 years (group 3) had a significantly longer hospital stay (3.0 days [2.0-5.0]) compared with group 1 (2.0 days [1.0-2.0]) or group 2 (2.0 days [1.0-3.0]) patients (P <.0001). CONCLUSION CA of AVNRT is highly effective and safe and does not pose an increased risk for complete AV block in patients over 75 years of age, despite a higher prevalence of structural heart disease. Antiarrhythmic drug therapy is often ineffective in this age group; thus, CA for AVNRT should be considered the preferred treatment even in elderly patients.

Impact of aortic valve calcification on the outcome of transcatheter aortic valve implantation: results from the prospective multicenter German TAVI registry.

Transcatheter aortic valve implantation (TAVI) is an emerging technology in patients with severe aortic stenosis.

Current state of cardiac rehabilitation in Germany: patient characteristics, risk factor management and control status, by education level

Background After the acute hospital stay, most cardiac patients in Germany are transferred for a 3–4-week period of inpatient cardiac rehabilitation. We aim to describe patient characteristics and risk factor management of cardiac rehabilitation patients with a focus on drug treatment and control status, differentiated by education level (low level, elementary school; intermediate level, secondary modern school; high level, grammar school/university). Methods Data covering a time period between 2003 and 2008 from 68,191 hospitalized patients in cardiac rehabilitation from a large-scale registry (Transparency Registry to Objectify Guideline- Oriented Risk Factor Management) were analyzed descriptively. Further, a multivariate model was applied to assess factors associated with good control of risk factors. Results In the total cohort, patients with a manifestation of coronary artery disease (mean age 63.7 years, males 71.7%) were referred to cardiac rehabilitation after having received percutaneous coronary intervention (51.6%) or coronary bypass surgery (39.5%). Statin therapy increased from 76.3% at entry to 88.9% at discharge, and low density lipoprotein cholesterol < 100 mg/dL rates increased from 31.1% to 69.6%. Mean fasting blood glucose decreased from 108 mg/dL to 104 mg/dL, and mean exercise capacity increased from 78 W to 95 W. Age and gender did not differ by education. In contrast with patients having high education, those with low education had more diabetes, hypertension, and peripheral arterial disease, had lower exercise capacity, and received less treatment with statins and guideline-orientated therapy in general. In the multivariate model, good control was significantly more likely in men (odds ratio 1.38; 95% confidence interval 1.30–1.46), less likely in patients of higher age (0.99; 0.99–0.99), with diabetes (0.90; 0.85–0.95), or peripheral arterial disease (0.88; 0.82–0.95). Compared with a low level education, a mid level education was associated with poor control (0.94; 0.89–0.99), while high education did not have a significant effect (1.08; 0.99–1.17). Conclusion Patients with different levels of education treated in cardiac rehabilitation did not differ relevantly in terms of demographics, but did differ in some clinical aspects. With respect to the ultimate goal of cardiac rehabilitation, ie, optimal control of risk factors, education level does not play an important role.

Treatment patterns and risk factor control in patients with and without metabolic syndrome in cardiac rehabilitation

Aim Metabolic syndrome (MetS) is a clustering of factors that are associated with increased cardiovascular risk. We aimed to investigate the proportion of patients with MetS in patients undergoing cardiac rehabilitation (CR), and to describe differences between patients with MetS compared to those without MetS with regard to (1) patient characteristics including demographics, risk factors, and comorbidities, (2) risk factor management including drug treatment, and (3) control status of risk factors at entry to CR and discharge from CR. Methods Post-hoc analysis of data from 27,904 inpatients (Transparency Registry to Objectify Guideline-Oriented Risk Factor Management registry) that underwent a CR period of about 3 weeks were analyzed descriptively in total and compared by their MetS status. Results In the total cohort, mean age was 64.3 years, (71.7% male), with no major differences between groups. Patients had been referred after a ST elevation of myocardial infarction event in 41.1% of cases, non-ST elevation of myocardial infarction in 21.8%, or angina pectoris in 16.7%. They had received a percutaneous coronary intervention in 55.1% and bypass surgery (coronary artery bypass graft) in 39.5%. Patients with MetS (n = 15,819) compared to those without MetS (n = 12,085) were less frequently males, and in terms of cardiac interventions, more often received coronary artery bypass surgery. Overall, statin use increased from 79.9% at entry to 95.0% at discharge (MetS: 79.7% to 95.2%). Patients with MetS compared to those without MetS received angiotensin converting enzyme inhibitors, angiotensin receptor blockers, oral antidiabetics, and insulin at entry and discharge more frequently, and less frequently clopidogrel and aspirin/clopidogrel combinations. Mean blood pressure was within the normal range at discharge, and did not differ substantially between groups (124/73 versus 120/72 mmHg). Overall, between entry and discharge, levels of total cholesterol, low density lipoprotein cholesterol, and triglycerides were substantially lowered, in particular in MetS patients. Thus, control rates of lipid parameters improved substantially, with the exception of high density lipoprotein cholesterol. Low density lipoprotein cholesterol rates <100 mg/dL increased from 38.7% at entry to 73.8% at discharge (MetS: from 39.4% to 74.6%) and triglycerides control rates (<150 mg/dL) from 58.1% to 70.4% (MetS: 43.7% to 62.2%). Physical fitness on exercise testing improved substantially in both groups. Conclusion Patients with and without MetS benefited substantially from the participation in CR, as their lipid profile, blood pressure, and physical fitness improved. Treatment effects were similar in the two groups.

How does the TRS 2°P score relate to real-world patients?

TIMI Study Group, Cardiovascular Division, Brigham and Women’s Hospital, Boston, MA, USA; Department of Molecular Medicine University of Pavia, and Cardiac Intensive Care Unit and Laboratories for Experimental Cardiology, IRCCS Fondazione Policlinico San Matteo, Pavia, Italy; Oslo University Hospital, Department of Cardiology B, and Institute of Clinical Sciences, University of Oslo, Norway; Merck&Co., Inc., Kenilworth, NJ, USA; Stiftung Institut für Herzinfarktforschung Ludwigshafen, Ludwigshafen, Germany; Department of Cardiology, Toulouse Rangueil Hospital, Toulouse University School of Medicine, Toulouse, France; and Medizinische Klinik B, Klinikum der Stadt Ludwigshafen, Ludwigshafen, Germany

PERSISTENT HIGH DISTANCE TO RECOMMENDED LDL-CHOLESTEROL-TARGETS DESPITE CHRONIC STATIN TREATMENT: RESULTS OF DYSIS

International asscociations such as EAS/ESC recommend LDL-C <70 mg/dl in very high risk patients. Despite chronic statin treatment, only a minority of patients achieve this target. We examined the median distance to this treatment target. Between 2008 and 2012, consecutive statin-treated