Transcatheter aortic valve implantation (TAVI) is already an accepted option to treat elderly patients with severe symptomatic aortic stenosis who are inoperable or at high surgical risk. However, ...short- and long-term mortality after TAVI remains an important issue, raising the need to further improve the technology of TAVI as well as to identify patients who will not benefit from TAVI. A total of 1,391 patients treated with TAVI at 27 hospitals were included in the German Transcatheter Aortic Valve Interventions – Registry. One-year follow-up data were available for 1,318 patients (94.8%), with a mean follow-up period of 12.9 ± 4.5 months. One-year mortality was 19.9%. Survivors and nonsurvivors showed multiple differences in patient characteristics, indications for interventions, preintervention and interventional characteristics, and postintervention events. A higher logistic European System for Cardiac Operative Risk Evaluation score was associated with higher 1-year mortality (p <0.0001). Cox proportional-hazards analysis revealed the following independent predictors of mortality: among preintervention findings: previous mitral insufficiency ≥II° (p = 0.0005), low-gradient aortic stenosis (p = 0.0008), previous decompensation (p = 0.0061), previous myocardial infarction (p = 0.0138), renal failure (p = 0.0180), previous New York Heart Association class IV (p = 0.0254), and female gender (p = 0.0346); among procedural factors: intraprocedural conversion to surgery (p = 0.0009), peri-intervention stroke (p = 0.0003), and residual aortic insufficiency ≥II° (p = 0.0022); and among postprocedural events: postintervention myocardial infarction (p = 0.0009) and postintervention pulmonary embolism (p = 0.0025). In conclusion, 1-year mortality after TAVI was 19.9% in this series. Patient characteristics and procedural as well as postintervention factors associated with mortality were identified, which may allow better patient selection and better care for these critically ill patients.
Stratification of patients with atrial fibrillation (AF) according to mechanistic and prognostic criteria may optimize the effectiveness and safety of catheter ablation. In women, AF is associated ...with more severe symptoms and worse prognosis.
We sought to assess sex-related differences in catheter ablation procedures and outcome in a large cohort of patients with AF.
A total of 3652 patients (1198 women 33%; 2454 men 67%) included in the German Ablation Registry were analyzed. Periprocedural parameters and outcome at 12-month follow-up were compared between male and female patients.
Women were older at the time of ablation (women: 63.6 years; men: 59.1 years; P < .0001) and exhibited a higher prevalence of paroxysmal AF (women: 72%; men: 61%; P < .0001). They were less often affected by cardiovascular disease and reduced left ventricular function. Energy application duration and overall procedure duration were shorter in women. Conversely, the rate of major inhospital complications was increased in female patients (1.9% vs 0.8%; P = .023) and mainly driven by major bleeding events. At follow-up, women experienced higher AF recurrence rates (women: 50%; men: 45%; P = .017) and more often received oral medication for rhythm and rate control. In addition, the rate of pacemaker implantation was higher in the female cohort. Women more frequently reported femoral access site complications (women: 6%; men: 3%; P < .001). Overall, male patients were more often free from AF-related symptoms and satisfied with the treatment.
Catheter ablation of AF was associated with a distinct sex-related outcome and complication profile that requires consideration in clinical practice.
Although radiofrequency (RF) ablation has long been the standard of care for atrial fibrillation (AF) ablation, cryoballoon technology has emerged as a feasible approach with promising results. ...Prospective multicenter registry data referring to both ablation technologies in AF ablation are lacking so far.
The purpose of this study was to report data from the German ablation registry with respect to efficacy and safety in pulmonary vein ablation with different energy sources for paroxysmal AF after 1-year follow-up.
A total of 2306 patients with symptomatic paroxysmal AF from the German ablation registry were included in this analysis. The cohort was divided into two groups according to the ablation energy source used: cryoballoon and RF ablation. MACCE was defined as a combination of death, myocardial infarction, or stroke.
AF recurrence rate after a single ablation procedure at 1 year follow-up was not significantly different between the two groups (45.8% after cryoablation and 45.4% after RF ablation, P = .87). Also, the rate of patients without AF recurrence and free of antiarrhythmic drug at 12-month follow-up was similar (cryoablation 44.2% and RF 41.4%, P = .25). MACCE occurred with an incidence of 0.7% within 500 days after cryoablation and 1.4% after RF ablation (P = .30). Persistent phrenic nerve palsy was more common after cryoablation compared to RF ablation (1.1% vs. 0.3%, P <.05).
AF recurrence rate at 1-year follow-up was similar in RF ablation compared to cryoablation, whereas the spectrum and relevance of complications were significantly different between the two ablation methods. This finding might influence the choice of ablation method offered to the individual paroxysmal AF patient.
Abstract Iron deficiency (ID) has been identified as an important comorbidity in patients with heart failure (HF). Intravenous iron therapy reduced symptoms and rehospitalisations of iron-deficient ...HF-patients in randomised trials. The present multicenter study investigated the “real-world” management of iron status in patients with HF. Consecutive patients with HF and ejection fraction < 40% were recruited and analyzed from 12/2010 to 10/2015 by 11 centres in Germany and Switzerland. Out of 1484 patients with HF, iron status was determined in only 923 patients (62.2%), despite participation of the centres in a registry focusing on ID and despite guideline recommendation to determine iron status. In patients with determined iron status, a prevalence of 54.7% (505 patients) for ID was observed. Iron therapy was performed in only 8.5% of the iron-deficient HF-patients; 2.6% were treated with intravenous iron therapy. The patients with iron therapy were characterised by a high rate of symptomatic HF and anemia. In conclusion despite strong evidence of beneficial effects of iron therapy on symptoms and rehospitalisations, diagnostic and therapeutic efforts on ID in HF are low in the actual clinical practice, and the awareness to diagnose and treat ID in HF should be strongly enforced.
Transcatheter aortic valve implantation (TAVI) is rapidly evolving in Germany. Especially severe reduced left ventricular ejection fraction (LVEF) is known as a prominent risk factor for adverse ...outcome in open heart surgery. Thus, the data of the prospective multicenter German Transcatheter Aortic Valve Interventions Registry were analyzed for outcomes in patients with severe depressed LVEF. Data of 1,432 patients were consecutively collected after transcatheter aortic valve implantation. Patients were divided into 2 groups (A: LVEF ≤30%, n = 169, age 79.9 ± 6.7 years, logES 34.2 ± 17.8%; B: LVEF >30%, n = 1,263, age 82.0 ± 6.1 years, logES 18.9 ± 12.0%), and procedural success rates, New York Heart Association classification, and quality of life were compared at 30 days and 1 year, respectively. Technical success was achieved in 95.9% (A) and 97.6% (B). Survival and the New York Heart Association classification at 30 days demonstrated an excellent outcome in both groups. There was a significant improvement according to the self-assessment in health condition (0 to 100 scale) with a much larger gain in group A (28 vs 19 patients, p <0.0001). Nevertheless, low cardiac output syndrome (12.3% vs 5.9%, p <0.01) and resuscitation (10.4% vs 5.6%, p <0.05) were more frequently seen in group A, contributing to a higher mortality at 30 days (14.3% vs 7.2%) and 1 year (33.7% vs 18.1%, p <0.001). In conclusion, this real-world registry demonstrated a comparably high success rate for patients with severe reduced LVEF and an early improvement in functional status as demonstrated by substantial benefit, despite a doubled postprocedural mortality.
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 presence of severe atherosclerosis of the ascending aorta, and its extreme form the “porcelain” aorta, is associated with a worse clinical outcome in patients undergoing surgical aortic valve ...replacement. Percutaneous transcatheter aortic valve implantation (TAVI) for severe symptomatic aortic stenosis can overcome this problem: 1,374 TAVI procedures were performed at 27 hospitals in 147 patients (10.7%) with and 1,227 (89.3%) without a porcelain aorta. The mean reported prevalence of a porcelain aorta at the hospitals was 7.8% ± 14.8% (range 0% to 70%). Diabetes mellitus (46.3% vs 33.2%, p = 0.00018), chronic obstructive pulmonary disease (43.5% vs 22.2%, p <0.0001), and peripheral arterial obstructive disease (34.7% vs 20.0%, p <0.0001) were more prevalent in patients with a porcelain aorta. In patients with a porcelain aorta, coronary ischemia occurred more often (2.0% vs 0.1%, p <0.0001), with a tendency toward a greater stroke rate (5.5% vs 2.8%, p = 0.08), greater in-hospital death rate (10.9% vs 8.1%, p = 0.24), and greater death or stroke rate (14.4% vs 10.2%, p = 0.12). On multivariate analysis, the presence of a porcelain aorta was not associated with in-hospital death (odds ratio 1.36, 95% confidence interval 0.72 to 2.55, p = 0.3441) nor in-hospital death or stroke (odds ratio 1.50, 95% confidence interval 0.81 to 2.47, p = 0.2207). In conclusion, in this real-world TAVI registry, a “porcelain” aorta was diagnosed in almost every tenth patient. Although differences were found in its frequency among the participating hospitals, the presence of a porcelain aorta was not associated with in-hospital death or stroke.
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.
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.
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).
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).
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.
Abstract Background We investigated the current management of unstable angina pectoris (UAP) in certified chest pain units (CPUs) in Germany and focused on the European Society of Cardiology (ESC) ...guideline-adherence in the timing of invasive strategies or choice of conservative treatment options. More specifically, we analyzed differences in clinical outcome with respect to guideline-adherence. Method Prospective data from 1400 UAP patients were collected. Analyses of high-risk criteria with indication for invasive management and 3-month clinical outcome data were performed. Guideline-adherence was tested for a primarily conservative strategy as well as for percutaneous coronary intervention (PCI) within <24 and <72 h after admission. Results Overall guideline-conforming management was performed in 38.2%. In UAP patients at risk, undertreatment caused by an insufficient consideration of risk criteria was obvious in 78%. Reciprocally, overtreatment in the absence of adequate risk markers was performed in 27%, whereas a guideline-conforming primarily conservative strategy was chosen in 73% of the low-risk patients. Together, the 3-month major adverse coronary and cerebrovascular events (MACCE) were low (3.6%). Nonetheless, guideline-conforming treatment was even associated with significantly lower MACCE rates (1.6% vs. 4.0%, p < 0.05). Conclusion The data suggest an inadequate adherence to ESC guidelines in nearly two thirds of the patients, particularly in those patients at high to intermediate risk with secondary risk factors, emphasizing the need for further attention to consistent risk profiling in the CPU and its certification process.
The prospective multicenter German Drug-Eluting Stent ( DES.DE ) registry is an observational study to analyze and evaluate the therapeutic principle of the differential drug-eluting stents ...(sirolimus- and paclitaxel-eluting stents) and bare metal stents under real world conditions in the context of the German healthcare system. The baseline clinical and angiographic characteristics and follow-up events for 1 year were recorded for all enrolled patients. In addition, a health economics assessment was performed at 3, 6, 9, and 12 months after initial stent placement. The composite of death, myocardial infarction, and stroke, defined as major adverse cardiac and cerebrovascular events, and target vessel revascularization were used as the primary objectives. From October 2005 to October 2006, 6,384 patients were enrolled (sirolimus-eluting stents, n = 2,137; paclitaxel-eluting stents, n = 2,740; bare metal stents, n = 485) at 98 Deutsches Drug-Eluting Stent Register sites. With similar baseline clinical and descriptive morphology of coronary artery disease between both drug-eluting stent groups, no differences were present at 1 year of follow-up in the rates of overall mortality (3.8% vs 4.1%), target vessel revascularization (10.4% vs 10.4%), overall stent thrombosis (3.6% vs 3.8%), and major adverse cardiac and cerebrovascular events (8.1% vs 8.0%). Compared with the bare metal stent group, patients treated with drug-eluting stents had significantly lower rates of myocardial infarction (3.2% vs 6.0%; p <0.01), stroke (1.2% vs 2.7%; p <0.05), and target vessel revascularization (10.4% vs 14.9%; p <0.01) without any difference in the stent thrombosis rate (3.7% vs 4.3%; p = 0.57) or mortality rate (4.0% vs 5.2%; p = 0.21). In conclusion, the data generated from the German Drug-Eluting Stent registry revealed no differences between patients receiving a paclitaxel-eluting stent and sirolimus-eluting stent in a “real-world” setting with regard to the clinical outcomes at 1 year.
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