NCT01176968.

Objectives Information on gender‐related differences in terms of baseline characteristics and clinical outcome of patients undergoing MitraClip® implantation in daily clinical practice have been studied in smaller populations previously. This study sought to additionally evaluate gender‐related differences in a larger German real‐world patient population. Methods and results We analyzed data from the prospective and multicenter German TRAMI Registry. Between 08/2010 and 07/2013 327 women and 501 men underwent MitraClip® implantation for significant mitral valve regurgitation. Female patients were significantly older and showed higher rates of frailty compared to men. In contrast, men had significantly higher rates of comorbidities compared to women. The majority of patients underwent MitraClip® implantation for secondary mitral regurgitation, with no significant gender‐related differences. MitraClip® treatment was equally effective in terms of procedural results and residual mitral regurgitation in women and men and complication rates were low. However, in this real‐world analysis severe bleeding complications were significantly higher in women (p = .02) and re‐intervention rates were significantly higher in men after MitraClip® treatment (p = .02). Women showed less improvement in functional NYHA class after MitraClip® treatment compared to men at 1‐year follow‐up (FU; p < .001). No significant differences between female and male patients were found in 1‐year mortality and in re‐hospitalization rates. Conclusion In this analysis from a large prospective, multicenter real‐world registry MitraClip® implantation is safe and effective for treatment of significant mitral regurgitation with equal postprocedural results and mortality rates during 1‐year follow‐up. Men and women showed a persisting and significant clinical benefit at 1‐year FU after treatment. Complication and re‐intervention rates were low. Additional studies are needed to further evaluate our findings on increased bleeding complications and decreased functional improvement in women at 1‐year follow‐up after MitraClip® therapy.

Stroke complicating TAVI is a serious complication with a clinically relevant incidence even in daily practice leading to a fivefold increase in 30-day-mortality rate, as well as a significant increase in morbidity and disability in patients, who survive this devastating complication. Further research is needed to identify risk factors and ways to reduce stroke after TAVI. © 2016 Wiley Periodicals, Inc.

These data from the early TAVI experience show a 5-year mortality of 59.1%. Some of the predictors of 5-year mortality seem to be modifiable, such as residual aortic regurgitation, type of TAVI access route and concomitant mitral regurgitation.

Background-Stroke is a rare but serious complication of percutaneous coronary interventions (PCIsIn multivariate analysis hemodynamic instability, age ≥75 years, history of stroke, and congestive heart failure were found to be independent predictors for periprocedural stroke in ACS, whereas only PCI of a bypass graft and renal failure could be identified as independent predictors for stroke in elective patients. Conclusions-Stroke as complication of PCI occurs rarely (0.4%) in clinical practice in Europe today. However, periinterventional stroke is still associated with an exceedingly high in-hospital mortality rate. Most predictors for periprocedural stroke are not modifiable and cannot be diminished before PCI. Therefore, treatment of patients with stroke after PCI needs further research. (Circ Cardiovasc Interv. 2013;6:362-369.)

Background: Transcatheter aortic valve replacement (TAVR) is increasingly being used for treatment of severe aortic valve stenosis in patients at intermediate risk for surgical aortic valve replacement (SAVR). Currently, real-world data comparing indications and clinical outcomes of patients at intermediate surgical risk undergoing isolated TAVR with those undergoing SAVR are scarce. Methods: We compared clinical characteristics and outcomes of patients with intermediate surgical risk (Society of Thoracic Surgeons score 4%–8%) who underwent isolated TAVR or conventional SAVR within the prospective, all-comers German Aortic Valve Registry. Results: A total of 7613 patients at intermediate surgical risk underwent isolated TAVR (n=6469) or SAVR (n=1144) at 92 sites in Germany between 2012 and 2014. Patients treated by TAVR were significantly older (82.5±5.0 versus 76.6±6.7 years, P <0.001) and had higher risk scores (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation]: 21.2±12.3% versus 14.2±9.5%, P <0.001; Society of Thoracic Surgeons score: 5.6±1.1 versus 5.2±1.0, P <0.001). Multivariable analyses revealed that advanced age, coronary artery disease, New York Heart Association class III/IV, pulmonary hypertension, prior cardiac decompensation, elective procedure, arterial occlusive disease, no diabetes mellitus, and a smaller aortic valve area were associated with performing TAVR instead of SAVR (all P <0.001). Unadjusted in-hospital mortality rates were equal for TAVR and SAVR (3.6% versus 3.6%, P =0.976), whereas unadjusted 1-year mortality was significantly higher in patients after TAVR (17.5% versus 10.8%, P <0.001). After propensity score matching, the difference in 1-year mortality between patients with TAVR and SAVR was no longer significant (17.1% versus 15.7%, P =0.59). Conclusions: Patients at intermediate risk undergoing TAVR differ significantly from those treated with SAVR with regard to age and baseline characteristics. Isolated TAVR and SAVR were associated with an in-hospital mortality rate of 3.6%. In the propensity score analysis, there was no significant difference in 1-year mortality between patients with TAVR and SAVR.

In the present day, coronary angiography and percutaneous coronary intervention are considered to be safe procedures with low complication rates in general. Nevertheless due to their widespread use and their application in a continually aging population known to carry a higher risk for complications, periprocedural stroke affects thousands of patients undergoing coronary angiography and percutaneous coronary intervention worldwide every year. Stroke is reported to occur in 0.05-0.1% of diagnostic cardiac catheterizations and in 0.18-0.44% of patients treated with percutaneous coronary intervention in clinical routine today. Despite all improvements in pharmacological and technical issues, the rate of stroke after cardiac catheterization has remained almost constant over the last 20 years of invasive cardiology of invasive and interventional cardiology, which is most probably due to the immutability of the majority of risk factors before cardiac procedures. An advanced age, arterial hypertension, diabetes mellitus, coronary angiography performed under emergency conditions, history of stroke, renal failure, the use of an intra-aortic balloon pump, congestive heart failure and interventions at bypass grafts have been identified as risk factors for periprocedural stroke in large registries. Due to exceedingly high rates of mortality and disability stroke after coronary angiography still has an enormous impact on the patient's prognosis and on quality of life. If patients survive this devastating complication, most of them suffer from persistent neurological deficits such as motor or speech disorders. For its low incidence and consecutively missing data from randomized clinical trials, an evidence-based treatment could not yet be established, and treatment options are generally based on case series and small studies only. Nevertheless, intra-arterial thrombolysis and mechanical embolectomy seem to be promising and relatively safe approaches in the treatment of periprocedural ischemic stroke. Further research by randomized trials and large registries are needed to validate its efficacy and safety.

Transcatheter aortic VinV with the balloon-expandable SAPIEN XT or SAPIEN 3 was similarly safe and effective. However, residual stenosis remains a concern, particularly in smaller bioprostheses and with increasing implantation depth.