Christoph A. Nienaber

The Sirolimus-eluting coronary stent in daily routine practice in Germany: trends in indications over the years. Results from the prospective multi-centre German Cypher Stent Registry.

BackgroundDrugeluting coronary stents (DES) are increasingly used during percutaneous coronary interventions (PCI). Due to limited budgets in Germany, no special reimbursement has been given for their use and therefore they were mainly used in selected patients.MethodsIn order to determine the change in indications in patients treated with a Sirolimus-eluting stent (SES) in daily clinical practice between 2002 and 2005, we analysed data from a prospective multi-centre DES registry, the German Cypher Stent Registry.ResultsFrom April 2002 until September 2005, 11 507 patients at 132 hospitals, who received at least one SES during their PCI, were included. Between 2002 and 2005, the median age of patients increased from 63 years to 66 years (p for trend <0.0001), whereas the prevalence of prior coronary bypass surgery (p<0.0001) and prior PCI (p<0.001) significantly decreased. Initial presentation of patients was stable over time, with a small increase of patients treated for non-ST elevation myocardial infarction (p=0.05). We found a significant increase in the treatment of complex stenoses (p<0.0001) as well as an increase in the proportion of chronic total occlusions (p<0.01). There was a steady increase in the proportion of patients treated for de novo lesions (p<0.0001), which was accompanied by a relative decrease in the proportion of patients treated for in-stent restenosis (p<0.0001). Concerning interventional characteristics a significant increase in the length of SES implanted per lesion, the numbers of SES implanted per lesion as well as an increase of the proportion of patients treated for more than one stenosis during one intervention could be observed (all p<0.0001). There was a significant decrease in the use of glycoprotein II b/IIIa antagonists during the PCI (2002: 26.5 to 14.2% in 2005, p<0.0001). MACE rates until hospital discharge did not change significantly over time.ConclusionsBetween 2002 and 2005 there were two trends in the use of SES: a) a significant increase in the use of SES for de novo lesions and b) a significant trend to use SES for longer lesions, smaller arteries, more complex lesions and more SES per lesion. In summary these findings indicate that still SES are mainly used in patients with lesions that are at high risk for restenosis.

Changes in operative strategy for patients enrolled in the International Registry of Acute Aortic Dissection interventional cohort program

Objective: Advancements in cardiothoracic surgery prompted investigation into changes in operative management for acute type A aortic dissections over time. Methods: One thousand seven hundred thirty‐two patients undergoing surgery for type A aortic dissection were identified from the International Registry of Acute Aortic Dissection Interventional Cohort Database. Patients were divided into time tertiles (T) (T1: 1996–2003, T2: 2004–2010, and T3: 2011–2016). Results: Frequency of valve sparing procures increased (T1: 3.9%, T2: 18.6%, and T3: 26.7%; trend P < .001). Biologic valves were increasingly utilized (T1: 35.6%, T2; 40.6%, and T3: 52.0%; trend P = .009), whereas mechanical valve use decreased (T1: 57.6%, T2: 58.0%, and T3: 45.4%; trend P = .027) for aortic valve replacement. Adjunctive cerebral perfusion use increased (T1: 67.1%, T2: 89.5%, and T3: 84.8%; trend P < .001), with increase in antegrade cerebral techniques (T1: 55.9%, T2: 58.8%, and T3: 66.1%; trend P = .005) and hypothermic circulatory arrest (T1: 80.1%, T2: 85.9%, and T3: 86.8%; trend P = .030). Arterial perfusion through axillary cannulation increased (T1: 18.0%, T2: 33.2%, and T3: 55.7%), whereas perfusion via a femoral approach diminished (T1: 76.0%, T2: 53.3%, and T3: 30.1%) (both P values < .001). Hemiarch replacement was utilized more frequently (T1: 27.0%, T2: 63.3%, and T3: 51.7%; trend P = .001) and partial arch was utilized less frequently (T1: 20.7%, T2: 12.0%, and T3: 8.4%; trend P < .001), whereas complete arch replacement was used similarly (P = .131). In‐hospital mortality significantly decreased (T1: 17.5%, T2: 15.8%, and T3: 12.2%; trend P = .017). Conclusions: There have been significant changes in operative strategy over time in the management of type A aortic dissection, with more frequent use of valve‐sparing procedures, bioprosthetic aortic valve substitutes, antegrade cerebral perfusion strategies, and hypothermic circulatory arrest. Most importantly, a significant decrease of in‐hospital mortality was observed during the 20‐year timespan.

Corrigendum to: 2014 ESC Guidelines on the diagnosis and treatment of aortic diseases

Corrigendum to: 2014 ESC Guidelines on the diagnosis and treatment of aortic diseases [Eur Heart Journal (2014) 35, 2873–2926,doi:10.1093/eurheartj/ehu281]. In Table 3, the radiation for MRI is “0” and not “-“. The corrected table is shown below.

Risk factors for clinical events at 1-year follow-up after drug-eluting stent implantation: results from the prospective multicenter German DES.DE registry.

BackgroundDrug-eluting stents (DES) have substantially reduced target vessel revascularization (TVR) after percutaneous coronary interventions. Risk factors for clinical events need to be redefined with this treatment option.Methods and resultsIn the prospective DES.DE registry, baseline clinical and angiographic characteristics as well as in-hospital and follow-up events were recorded for all enrolled patients. Between October 2005 and May 2009, 21,774 patients receiving DES were enrolled at 98 DES.DE sites. The composite of death, myocardial infarction (MI) and stroke defined as major adverse cardiac and cerebrovascular events (MACCE) and TVR were predefined as primary endpoints. At 1-year follow-up rates for overall death, MI, stroke, MACCE, TVR and definite stent thrombosis were 2.7, 3.1, 1.4, 7.1, 11.5 and 0.6xa0%, respectively. Aside from well-known risk factors like age, diabetes mellitus and triple-vessel disease, stratification in patients with or without MACCE revealed atrial fibrillation, non-ST-segment elevation myocardial infarction, renal failure, impaired ejection fraction and peripheral vascular disease as strong predictors of MACCE at 1xa0year.ConclusionData collected in the DES.DE registry, reflecting the clinical practice in Germany, revealed favorable clinical outcomes after DES implantation in a real world setting but also identifying several high-risk populations.

Small aortic root in aortic valve stenosis: clinical characteristics and prognostic implications

AimsnIn aortic valve stenosis (AS), having a small aortic root may influence both the assessment of AS severity and the treatment strategy. The aim was to test the prognostic implications of having a small aortic root in AS within a large prospective study.nnnMethods and resultsnWe used data from 4.3-year follow-up of 1560 patients with asymptomatic, initially mostly moderate AS enrolled in the Simvastatin and Ezetimibe in Aortic Stenosis study. A small aortic root was defined as inner aortic sinotubular junction diameter indexed for body height <1.4 cm/m in women and <1.5 cm/m in men. A small aortic root was found in 270 patients (17.3%) at baseline. Having a small aortic root was associated with larger aortic root wall thickness, higher pressure recovery, lower systemic arterial compliance, left ventricular mass index, and female sex in a multivariable logistic regression analysis (all P < 0.05). In the Cox regression analysis, having a small aortic root at baseline was associated with higher hazard rates of ischaemic cardiovascular events (n = 268; HR 1.55, 95% CI 1.16-2.06), non-haemorrhagic stroke (n = 55; HR 1.88, 95% CI 1.04-3.41), and cardiovascular death (n = 81; HR 2.08, 95% CI 1.28-3.39) (all P < 0.05) after adjusting for confounders, including randomized study treatment, sex, hypertension, AS severity, and aortic valve replacement.nnnConclusionnIn AS patients without known cardiovascular disease or diabetes, having a small aortic root was associated with increased ischaemic cardiovascular events and mortality. The results suggest a relation between the presence of a small aortic root and that of subclinical atherosclerosis.nnnClinical trial registrationnClinicalTrials.gov identifier: NCT00092677.

The IRAD and beyond: what have we unravelled so far?

Acute aortic dissection is a life-threatening condition associated with high morbidity and mortality rates and a long history of challenges to both diagnose and manage this condition successfully. The International Registry of Acute Aortic Dissection (IRAD) was established in 1996 as a global database to understand this old disease better and improve care for dissection. IRAD initially targeted various areas including etiological factors of dissection, modes of presentation, clinical features, physical findings, imaging, management, and outcomes, and is currently branching out in more specific fields such as endovascular intervention, genetic profiling, and functional imaging. Although presenting symptoms and physical findings have not changed significantly over two decades, the widespread use of computed tomography is standard and has improved the diagnostic pathway. Moreover, more patients are managed with appropriate procedures, such as surgery in type A, and endovascular therapy in subsets of type B aortic dissection. With these ongoing improvements in swift diagnostic work-up and therapeutic care, fewer patients are not getting appropriate treatment and more patients survive once they reach hospital.

The Art of Stratifying Patients With Type B Aortic Dissection.

The management strategy for patients with “uncomplicated” type B aortic dissection has been the subject of ongoing debate since the advent of modern endovascular options to reconstruct a dissected aorta, and thereby, induce vascular remodeling [(1,2)][1]. Patient management for complicated type

Acute aortic dissections with entry tear in the arch: a report from the International Registry of Acute Aortic Dissection (IRAD)

Objective: To analyze presentation, management, and outcomes of acute aortic dissections with proximal entry tear in the arch. Methods: Patients enrolled in the International Registry of Acute Aortic Dissection and entry tear in the arch were classified into 2 groups: arch A (retrograde extension into the ascending aorta with or without antegrade extension) and arch B (only antegrade extension into the descending aorta or further distally). Presentation, management, and in‐hospital outcomes of the 2 groups were compared. Results: The arch A (n = 228) and arch B (n = 140) groups were similar concerning the presence of any preoperative complication (68.4% vs 60.0%; P = .115), but the types of complication were different. Arch A presented more commonly with shock, neurologic complications, cardiac tamponade, and grade 3 or 4 aortic valve insufficiency and less frequently with refractory hypertension, visceral ischemia, extension of dissection, and aortic rupture. Management for both groups were open surgery (77.6% vs 18.6%; P < .001), endovascular treatment (3.5% vs 25.0%; P < .001), and medical management (16.2% vs 51.4%; P < .001). Overall in‐hospital mortality was similar (16.7% vs 19.3%; P = .574), but mortality tended to be lower in the arch A group after open surgery (15.3% vs 30.8%; P = .090), and higher after endovascular (25.0% vs 14.3%; P = .597) or medical treatment (24.3% vs 13.9%; P = .191), although the differences were not significant. Conclusions: Acute aortic dissection patients with primary entry tear in the arch are currently managed by a patient‐specific approach. In choosing the management type of these patients, it may be advisable to stratify them based on retrograde or only antegrade extension of the dissection. Graphical abstract Figure. No caption available.

Early and midterm outcome of Multilayer Flow Modulator stent for complex aortic aneurysm treatment in Germany

Objective: The objective of this study was to assess the early and midterm outcomes of endovascular repair of complex aortic aneurysm cases using the Multilayer Flow Modulator (MFM; Cardiatis, Isnes, Belgium) endograft in Germany. Methods: A retrospective study including patients presenting with abdominal aortic aneurysm (AAA), thoracic aortic aneurysm, or thoracoabdominal aortic aneurysm treated with the MFM was conducted in Germany. Mortality and morbidity (in terms of spinal cord ischemia, visceral ischemia, and stroke) at 30 days postoperatively were evaluated. In addition, during follow‐up, freedom from reintervention, rupture, and failure mode were also assessed. Results: Between 2009 and 2014, a total of 61 patients with AAA, thoracoabdominal aortic aneurysm, or thoracic aortic aneurysm were treated with the MFM endograft in 29 hospitals around Germany. However, data of 40 patients with a mean age of 73.4 ± 11.2 years (72.5% male; 29/40) and mean aortic aneurysm diameter of 60.3 ± 16.6 mm from 14 hospitals were available for this retrospective study. Thirty‐seven (93%) patients were treated urgently. In 12 cases (12/40 [30%]), patients were treated outside instructions for use because of aortic aneurysm diameter >65 mm. A total of 69 MFM stents were used (1.7/patient). The technical success rate was 95% (38/40). Postoperatively, no patient presented with spinal cord ischemia, renal function deterioration, stroke, or intestinal ischemia, except for one patient who developed multiorgan failure because of early stent migration. The intraoperative and 30‐day mortality rate was 0% and 2.5%, respectively. The mean follow‐up was 12.9 months (±14.9 months), with a survival rate at 1 month, 6 months, and 12 months of 97%, 78%, and 70%, respectively. Freedom from failure mode (type I or II) at 1 month, 6 months, and 12 months was 97.5%, 88%, and 86%, respectively, and visceral vessel patency was 99.3% (155/156 available). During follow‐up, 4 patients (4/39 [10%]) had an aneurysm sac rupture and 10 (10/39 [25%]) underwent a reintervention. Freedom from rupture and freedom from reintervention at 1 month, 6 months, and 12 months were 97.5% and 100%, 96% and 84%, and 86% and 75%, respectively. Conclusions: The use of the MFM for endovascular treatment of complex aortic aneurysm in urgent cases appears to be technically feasible in terms of mortality and morbidity, with moderate 30‐day and acceptable midterm outcomes. Reinterventions may be needed to expand the utility of outcomes.

False lumen intervention to promote remodelling and thrombosis—The FLIRT concept in aortic dissection

Thoracic endovascular aortic repair (TEVAR) has changed the management of aortic dissection by induced remodelling. Beyond reconstructing the true lumen, we describe the concept of False Lumen Intervention to promote Remodelling and Thrombosis (FLIRT) in both type A and B aortic dissection.