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Abdel-Wahab M.,Academic Teaching Hospital of the Universities of Kiel and Hamburg | Horack M.,University of Heidelberg | Gerckens U.,Helios Hospital | Schuler G.,University of Leipzig | And 5 more authors.
Clinical Research in Cardiology | Year: 2012

Objective: To examine the prevalence and impact of concomitant coronary artery disease (CAD) on short-term outcome after transcatheter aortic valve implantation (TAVI). Background: The prevalence of CAD in patients undergoing surgical aortic valve replacement is estimated at 30-50 % and its presence increases procedural risk. The prevalence and impact of CAD on outcome after TAVI are not well defined. Methods: We analyzed 1,382 patients enrolled in the German TAVI registry; the majority (81 %) received the Medtronic CoreValve. The presence of coronary lesions with ≥50 % stenosis on pre-TAVI angiography defined the existence of concomitant CAD. Results: 859 patients (62.2 %) had concomitant CAD, of which 534 (62.3 %) had multi-vessel and 83 (9.7 %) left main disease. Patients with CAD were younger (81.5 ± 6.1 vs. 82.1 ± 6.3 years, p<0.05), more commonly males (49.4 vs. 30.0 %, p < 0.0001) and diabetics (36.9 vs. 31.2 %, p < 0.05), and had a worse Canadian Cardiovascular Society angina class at baseline compared to patients with no CAD. During TAVI patients with CAD more often required additional coronary intervention and had longer procedures, but procedural success rates were similar (97.1 vs. 97.7 %). Crude in-hospital mortality was higher in patients with CAD (10.0 vs. 5.5 %, OR 1.90, 95 % CI 1.23-2.93), but this was not significant after adjustment for confounders (adjusted OR 1.41, 95 % CI 0.85-2.33). Both groups had significant improvement in 30-day symptoms and quality of life. Conclusion: The prevalence of CAD in contemporary TAVI patients is high. Its presence characterizes a high-risk population and is associated with increased crude short-term mortality, largely explained by co-morbidities, but does not limit functional improvement after TAVI. © The Author(s) 2012.

Jose J.,Academic Teaching Hospital of the Universities of Kiel and Hamburg | Jose J.,Christian Medical College Hospital | Manik G.,Christian Medical College Hospital | Abdel-Wahab M.,Academic Teaching Hospital of the Universities of Kiel and Hamburg
Indian Heart Journal | Year: 2015

Transcatheter aortic valve implantation (TAVI) has revolutionized the management of elderly patients with symptomatic severe aortic stenosis in the western world. It is a valuable alternative to surgical aortic valve replacement in patients, who are inoperable or at high surgical risk due to co-morbidities. The prevalence of aortic stenosis increases sharply with age after the sixth decade and is expected to have a significant impact on the geriatric health care system of India, given the rapid increase in life expectancy in recent years. Although a decade has passed since the first TAVI implantation, it is yet to penetrate most of the developing countries in a major way. This short review focuses on fundamentals of initiating a TAVI program based on the experience of a high volume TAVI center with a successful program in Germany. © 2015 Cardiological Society of India.

Abdel-Wahab M.,Academic Teaching Hospital of the Universities of Kiel and Hamburg | Mehilli J.,Ludwig Maximilians University of Munich | Neumann F.-J.,Albert Ludwigs University of Freiburg | Kurz T.,University of Lubeck | And 7 more authors.
JAMA - Journal of the American Medical Association | Year: 2014

IMPORTANCE: Transcatheter aortic valve replacement (TAVR) is an effective treatment option for high-risk patients with severe aortic stenosis. Different from surgery, transcatheter deployment of valves requires either a balloon-expandable or self-expandable system. A randomized comparison of these 2 systems has not been performed. OBJECTIVE: To determine whether the balloon-expandable device is associated with a better success rate than the self-expandable device. DESIGN, SETTING, AND PATIENTS: The CHOICE studywas an investigator-initiated trial in high-risk patients with severe aortic stenosis and an anatomy suitable for the transfemoral TAVR procedure. One hundred twenty-one patients were randomly assigned to receive a balloon-expandable valve (Edwards Sapien XT) and 120 were assigned to receive a self-expandable valve (Medtronic CoreValve). Patients were enrolled between March 2012 and December 2013 at 5 centers in Germany. INTERVENTIONS: Transfemoral TAVR with a balloon-expandable or self-expandable device. MAIN OUTCOMES AND MEASURES: The primary end pointwas device success, which is a composite end point including successful vascular access and deployment of the device and retrieval of the delivery system, correct position of the device, intended performance of the heart valve without moderate or severe regurgitation, and only 1 valve implanted in the proper anatomical location. Secondary end points included cardiovascular mortality, bleeding and vascular complications, postprocedural pacemaker placement, and a combined safety end point at 30 days, including all-cause mortality, major stroke, and other serious complications. RESULTS: Device success occurred in 116 of 121 patients (95.9%) in the balloon-expandable valve group and 93 of 120 patients (77.5%) in the self-expandable valve group (relative risk [RR], 1.24, 95%CI, 1.12-1.37, P < .001). This was attributed to a significantly lower frequency of residual more-than-mild aortic regurgitation (4.1%vs 18.3%; RR, 0.23; 95%CI, 0.09-0.58; P < .001) and the less frequent need for implanting more than 1 valve (0.8%vs 5.8%, P = .03) in the balloon-expandable valve group. Cardiovascular mortality at 30 days was 4.1% in the balloon-expandable valve group and 4.3%in the self-expandable valve group (RR, 0.97; 95% CI, 0.29-3.25; P = .99). Bleeding and vascular complications were not significantly different, and the combined safety end point occurred in 18.2%of those in the balloon-expandable valve group and 23.1%of the self-expandable valve group (RR, 0.79; 95%CI, 0.48-1.30; P = .42). Placement of a new permanent pacemaker was less frequent in the balloon-expandable valve group (17.3%vs 37.6%, P = .001). CONCLUSIONS AND RELEVANCE: Among patients with high-risk aortic stenosis undergoing TAVR, the use of a balloon-expandable valve resulted in a greater rate of device success than use of a self-expandable valve. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01645202. Copyright 2014 American Medical Association. All rights reserved.

Abdel-Wahab M.,Academic Teaching Hospital of the Universities of Kiel and Hamburg | Zahn R.,Heart Center Ludwigshafen | Gerckens U.,Gemeinschaftskrankenhaus | Linke A.,University of Leipzig | And 8 more authors.
Heart | Year: 2014

Objective: Residual aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) has been associated with increased mortality. Nevertheless, a considerable proportion of these patients survives and appears to tolerate AR. Identification of patients at higher risk of death may assist in tailoring therapy, but predictors of mortality in this subset of patients is largely unknown. Methods: A total of 1432 patients were included in the German TAVI registry. One-year follow-up data were available for 1318 patients (92%). Of the latter, 201 patients (15.2%) had more-than-mild AR as evaluated by angiography and represent the population of the current analysis. Among these patients, baseline demographic, clinical, echocardiographic and angiographic characteristics were compared among survivors and non-survivors to identify factors associated with mortality at 1 year. Results: Mean age was 81.2±6.6 years and men represented 55%. The mean logistic EuroSCORE was 22±15%. Overall, 92% of patients received the Medtronic CoreValve and 8% received the Edwards Sapien valve. At 1 year, 61 patients (31%) with more-than-mild post-TAVI AR had died. Compared with patients who survived, patients who died had more commonly coronary artery disease, peripheral arterial disease and chronic renal impairment. Patients who died had a lower baseline LVEF (44±18% vs 52±16%, p=0.002), higher prevalence of more-than-mild (≥2+) mitral regurgitation (44% vs 27%, p=0.001), and a higher systolic pulmonary artery pressure (51±18 mm Hg vs 44±19 mm Hg, p=0.002), but the severity of aortic stenosis was similar, and the prevalence and severity of pre-TAVI AR was comparable (any AR in 88% vs 83%, respectively, p=0.29). Using Cox regression analysis, only baseline mitral regurgitation ≥2+ (HR 1.77, 95% CI 1.05 to 2.99, p=0.03) and systolic pulmonary artery pressure (HR 1.15, 95% CI 1.01 to 1.33, p=0.04) were independently associated with 1-year mortality, while female gender was protective (HR 0.54, 95% CI 0.30 to 0.96, p=0.03). Conclusions: We identi fied preprocedural characteristics associated with 1-year mortality in patients with more-than-mild AR after TAVI. More-than-mild baseline mitral regurgitation, higher systolic pulmonary artery pressure and male gender were independently associated with worse outcome.

Abdel-Wahab M.,Academic Teaching Hospital of the Universities of Kiel and Hamburg | Richardt G.,Academic Teaching Hospital of the Universities of Kiel and Hamburg
EuroIntervention | Year: 2014

Transcatheter aortic valve implantation (TAVI) has developed rapidly in the past few years and is expected to expand further in the near future. A reasonable number of large multicentre registries and randomised clinical trials have been performed, which have provided a considerable quality of evidence necessary to ensure optimal use and optimal patient outcomes. Currently, a large number of different valves have been approved in Europe, with a varying amount of supporting evidence, which complicates the process of valve type selection. This article reviews the evolution and fundamental aspects of prosthesis type selection in patients undergoing TAVI, and summarises the most relevant clinical studies in this context. © Europa Digital & Publishing 2014. All rights reserved.

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