Surgical cut-down or percutaneous access-which is best for less vascular access complications in transfemoral TAVI?

OBJECTIVES: Objective of the present study was to compare VARC-2 access and bleeding complications of a complete percutaneous versus a surgical cut-down approach for transfemoral TAVI "in a real world-all comers" setting. BACKGROUND: The ideal approach for transfemoral TAVI is still part of a lively debate. Until today, for none of the available techniques superiority could be demonstrated. The present study adds a considerable number of patients to the available experience. METHODS: The study included 334 consecutive patients, including 199 patients in the percutaneous and 135 patients in the cut-down group. Mean patient's age was 81.4 ± 4.6. Calculated logistic EuroSCORE correlated an intermediate to high surgical risk (17.8% ± 12.3%). Primary study endpoints were vascular access site as well as bleeding complications according the actual VARC-2 criteria. RESULTS: Mean procedure time was significantly shorter in the cut-down group (69 ± 19 min vs. 91 ± 22 min; P < 0.01). Overall rate of VARC-2 access complications were significantly more frequent in the percutaneous group (n = 41/199; 20.6% vs. n = 11/135; 8.1%; P = 0.04); the incidence of major complications did not differ significantly (P = 0.19). VARC-2 bleeding complications were more frequent in the percutaneous group as well (18.1% vs. 4.4%; P = 0.029). Hospital stay differed not significantly (P = 0.214). Hospital mortality was 3.5% in the percutaneous group and 1.5% in the cut-down group (P = n.s.). CONCLUSION: Surgical cut-down provided a convenient and controlled access, resulting in less access and bleeding complications. Nontheless, major access complication differed not significantly. Both approaches must be seen as complementary techniques. A portfolio containing both techniques is the exclusive way to provide a tailor-made and patient-orientated approach. © 2015 Wiley Periodicals, Inc.

[Treatment of acute heart failure]. / Therapie der akuten Herzinsuffizienz.

Acute heart failure is a symptom complex of heterogeneous etiology. Clinically, it comprises a broad spectrum ranging from hypertensive pulmonary edema in patients with preserved left ventricular systolic function up to cardiogenic shock in patients with severely depressed left ventricular function. The pathophysiology of acute heart failure is based on a mismatch between myocardial pump function and afterload. Besides causal measures, vasodilators and diuretics are the mainstay of therapy. Catecholamines are indicated only when other drugs are unsuccessful. Opioids are often used in clinical practice but should be used cautiously as they are associated with a negative prognosis. Further adjunctive treatment consists of thromboembolism prophylaxis, non-invasive ventilation and in some cases mechanical circulatory support and renal replacement therapy. This article discusses the differential use of these treatment modalities.

Direct reimplantation as an alternative approach for treatment of anomalous aortic origin of the right coronary artery.

Anomalous aortic origin of the coronary artery (AAOCA) is a rare cardiac anomaly associated with myocardial ischemia, infarction, and even sudden death. We report 2 patients presenting with AAOCA of the right coronary artery originating from the left coronary sinus with an initial intramural course. In both patients, we performed uncomplicated direct reimplantation of the right coronary artery into the right coronary sinus. For this purpose, the right coronary artery was dissected from the transmural emersion point out of the aortic wall, subsequently as proximal as possible transected and directly reimplanted into the right coronary sinus. In both cases, the postoperative course was uneventful, and cardiac computed tomography confirmed excellent postoperative results after 1 year of follow-up. This technique is a convenient and easily performable approach, characterized by short cross-clamp times and avoidance of aortotomy, and thus is an excellent alternative strategy.

Comparison between on-label versus off-label use of drug-eluting coronary stents in clinical practice: results from the German DES.DE-Registry.

BACKGROUND: Observational studies from the USA have demonstrated that off-label use of drug-eluting stents (DES) is common. Data on off-label use in Western Europe are limited. METHODS: We analyzed the data of consecutive patients receiving DES prospectively enrolled in the multicenter German DES.DE registry (Deutsches Drug-Eluting Stent Register) between October 2005 and October 2006. Off-label use was defined in the presence of one of the following criteria: ST-elevation myocardial infarction, in-stent stenosis, chronic total occlusion, lesions in a bypass graft, in bifurcation or left main stem, stent length per lesion ≥32 mm, and vessel diameter <2.5 or >3.5 mm. RESULTS: Overall, 4,295 patients were included in this analysis and divided into two groups: 2,366 (55.1%) received DES for off-label and 1,929 (44.9%) for on-label indications. There were substantial differences in the rates of off-label use at the participating hospitals. Patients with off-label DES more often presented with high-risk features such as acute coronary syndrome, cardiogenic shock, congestive heart failure, and more complex coronary anatomy. Among hospital survivors, the incidence of the composite endpoint of death, myocardial infarction and stroke (MACCE) (9.2 vs. 7.4%, p < 0.05), and target vessel revascularization (TVR) (11.3 vs. 9.1%, p < 0.05) was increased in the off-label group at the 1-year follow-up. However, in the multivariate analysis off-label use was not linked with an elevated risk for MACCE (hazard ratio 0.86, 95% confidence interval 0.62-1.18) and TVR (hazard ratio 1.05, 95% confidence interval 0.78-1.42). CONCLUSIONS: In clinical practice, DES was very frequently used off-label. After adjustment for confounding variables, off-label use was not associated with an increase of adverse events.

Clinical outcomes after sirolimus-eluting, paclitaxel-eluting, and bare metal stents (from the first phase of the prospective multicenter German DES.DE Registry).

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.

Cobalt-chrome MULTI-LINK VISION-stent implantation in diabetics and complex lesions: results from the DaVinci-Registry.

AIMS: Restenosis in bare-metal stents is in part related to stent design and material. Optimized strut design of cobalt-chrome (CoCr) stents may yield nearly comparable results to drug-eluting stents (DES) in selected lesions. The prospective multicenter DaVinci registry investigates the clinical outcome of a CoCr coronary stent (MULTI-LINK VISION), particularly in terms of patients with diabetes and complex lesions (B1, B2, C). METHODS AND RESULTS: The prospective internet-based registry included 1,344 patients (76% males, aged 66 +/- 10 years) undergoing stent implantation (n = 1,642) in 32 centres from July 2003 to June 2004. Follow-up data (median 9 +/- 1 months) of this cohort were available for 1,289 patients (98.1%). Of these patients 327 (26.2%) were diabetics. In total, 1,429 de-novo lesions (A 11.9%, B1 47.7%, B2 31.6%, C 8.8%) were treated with the CoCr stent. The predefined primary endpoint was defined as a composite of death, Q-wave myocardial infarction (STEMI), non-STEMI (NSTEMI), target vessel revascularization (TVR) by coronary bypass graft (CABG) or PCI at 270 days (target vessel failure, TVF). Secondary endpoints include death, time to the first myocardial infarction, TVR and CABG. The cumulative incidence of major adverse cardiac events (MACE) was 12.4% with 0.8% deaths, 1.5% non-fatal MI, and 9.7% TVR. TVF in the overall cohort was documented in 137 (10.8%) patients. For diabetics and complex lesions TVF was 13.8% (95% CI 4.2-18) and 11.4% (95% CI 2.0-13.3), respectively. CONCLUSION: This large registry confirms good acute and long-term success of CoCr stents making this strategy valuable, particularly in a special cohort (diabetics and complex lesions) as long as late stent thrombosis with DES plays a role and short-term antiplatelet therapy is favoured.