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German Aortic Valve Registry: differential 1 year outcome in TAVI procedures

Session Registry Hot Line: Valves and heart failure

Speaker Christian Hamm

Event : ESC Congress 2014

  • Topic : valvular, myocardial, pericardial, pulmonary, congenital heart disease
  • Sub-topic : Valvular Heart Disease – Clinical
  • Session type : Clinical Trial Update

The free consultation period for this content is over.

It is now only available year-round to ESC Professional Members, Fellows of the ESC, and Young combined Members

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Registry Hot Line: Valves and heart failure

ESC Congress 2014 - Hot Line report

Resources are published as they become available during the congress


German Aortic Valve Registry: differential 1 year outcome in TAVI procedures

Christian Hamm, FESCBy Christian Hamm, FESC (Bad Nauheim, Germany)
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C W. Hamm 1, H. Moellmann 1, T. Walther 1, F. Mohr 2
(1) Kerckhoff Clinic, Bad Nauheim, Germany
(2) Heart Center of Leipzig, Leipzig, Germany


The nationwide German Aortic valve RegistrY (GARY) was established by the German Cardiac Society and the Cardiac Society for Thoracic and
Cardiovascular Surgery to evaluate contemporary treatment of aortic valve disease, including transcatheter aortic valve implantation (T-AVI).
Out of 9111 patients undergoing T-AVI in 2011 and 2012, one-year followup was complete in 97.6%. Patients were 81±6 years old in mean, 55.4% were female, and the patient risk profile according to the logistic EuroSCORE I was 24±17%. GARY is supported by unrestricted grants from medical companies and data are managed through an independent research institute for quality and patient safety.
In this all-comers T-AVI cohort in-hospital mortality was 5.2% and one-year mortality was 21.3%. Rehospitalization due to complications of the procedure was low (5.2%). Patients treated with a transvascular versus transapical approach had significantly lower in-hospital (4.6% vs. 6.8%) and one-year follow-up (19.8% vs. 24.9%) mortalities (p<0.001 for both). Residual aortic regurgitation, even when trivial, was associated with increased mortality at one year. The implantation of various heartvalve-prosthesis led to different outcomes, but these differences were not statistically significant.
T-AVI procedures in this large and unselected all-comers cohort of high-risk patients yield good early and one-year outcomes. Different approaches and devices were associated with meaningful differences and may impact clinical decision making in the future.

Pregnancy in women with a mechanical valve prosthesis

Jolien Roos-Hesselink, FESCBy Jolien W Roos-Hesselink, FESC (Rotterdam, Netherlands)
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JW. Roos-Hesselink 1, I M. Van Hagen 1, MR. Johnson 2, R. Hall 3
(1) Erasmus Medical Center, Cardiology, Rotterdam, Netherlands (2) Chelsea and Westminster Hospital NHS Trust, Obstetrics, London, United Kingdom (3) Norfolk and Norwich University Hospital, Cardiology, Norwich, United Kingdom


Cardiac disease is one of the leading causes of maternal mortality. Pregnancy induces not only a major hemodynamic burden but also a hypercoagulable state. Therefore, pregnant women with mechanical valve prostheses are at particularly high risk of thrombotic complications associated with the valve. Effective anticoagulation is essential to prevent these problems, but inevitably this carries an increased risk of hemorrhagic events, particularly during delivery. Previous small studies (e.g. the ZAHARA study), suggest that having a mechanical valve is a strong risk factor for an adverse pregnancy outcome. Further, they highlight that although oral anticoagulation is the optimal treatment for the mother, it is associated with a higher miscarriage rate and fetal abnormalities, and conversely that although heparin is safe for the baby it is suboptimal for the mother. The lack of any large studies means that current guidelines only give level C (weak) recommendations in this important area. Thus, large prospective studies are desperately needed to define the optimal treatment regimen.
The Registry On Pregnancy And Cardiac disease (ROPAC) is an ongoing worldwide registry of pregnancy in women with structural cardiac disease, initiated by the ESC working groups on “Valvular heart disease” and “Congenital heart disease”. From January 2008 until April 2014, seventy-one centers from 40 countries entered 2500 pregnancies in women with cardiac disease. More than two hundred patients with mechanical valve prostheses were included. This is the largest study of its type to date.  We will report on the incidence of hemorrhagic events, valve thrombosis and other complications, as well as maternal and fetal outcomes in this group. An overview of the used anticoagulation regimens will be provided to give insight in the current practice and to outline the best available strategy for prevention of complications. This information will provide tools for better counseling and treatment of these high-risk patients.

REMEDY: The Global Rheumatic Heart Disease Registry -Clinical characteristics, sequelae and gaps in evidence-based interventions in 3310 children and adults from 14 countries

Liesl ZuhlkeBy Liesl Zuhlke, (Cape Town, South Africa)
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Liesl Zühlke, 1, 2; Mark Engel,2; Ganesan Karthikeyan, 3; Teo Koon, 4; Salim Yusuf,4; Bongani M Mayosi 2; for the Global Rheumatic Heart Disease Registry (REMEDY) Investigators
1-Division of Paediatric Cardiology, Department of Paediatrics and Child Health, University of Cape Town, Cape Town, South Africa;
2-Department of Medicine, Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa
3-Department of Cardiology, All India Institute of Medical Sciences Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa
4-Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada.


RHD is the principal cause of heart disease in the young and a significant contributor to cardiovascular disease-related morbidity and mortality in developing countries. Yet, there is a paucity of contemporary data documenting the clinical characteristics, sequelae and gaps in evidence-based interventions among affected patients in the developing world.
The Global Rheumatic Heart Disease Registry (REMEDY) is prospective, international, multicentre, hospital-based registry comprehensively characterising RHD over two-years.
We enrolled 3343 patients (median age 28 years, 66.2% female) presenting with RHD at 25 hospitals in 14 low and middle-income countries between January 2010 and November 2012. The majority (n=2136, 63.9%) had moderate to severe multivalvular disease complicated by congestive heart failure (33.4%), pulmonary hypertension (28.8%), atrial fibrillation (AF) (21.8%), stroke (7.1%), infective endocarditis (4%), and major bleeding (2.7%). One quarter of adults and 5.3% of children had decreased left ventricular (LV) systolic function; 23% of adults and 14.1% of children had dilated LVs. Fifty-five percent (n = 1761) of patients were on secondary antibiotic prophylaxis. Oral anticoagulants were prescribed in 69.5% (n = 946) of patients with mechanical valves (n = 501), AF (n = 397), and high-risk mitral stenosis in sinus rhythm (n = 48). However, only 28.3% (n = 269) had a therapeutic international normalised ratio (INR). Among 1825 women of child-bearing age (12-51 years), only 3.7% (n = 65) were on contraception. The utilisation of valvuloplasty and valve surgery was higher in upper-middle compared to lower-income countries (p=0.001).
RHD patients were young, predominantly female, and had high prevalence of major cardiovascular complications. There is suboptimal utilization of secondary antibiotic prophylaxis, oral anticoagulation, and contraception, and variations in the use of percutaneous and surgical interventions by country income level.

Is TAVI the treatment of choice for high risk diabetic patients with aortic stenosis ? insights from the FRANCE 2 Registry

Professor Eric Van Belle, FESCBy Eric Van Belle, FESC (Lille Cedex, France)
Eric Van Belle 1,2,MD, PhD; Emmanuel Teiger,14,MD, PhD, Françis Juthier 1,2,MD; Antoine Rauch 1,2,MD;
Sophie Susen 1,2,MD,PhD; Bernard Iung 4 ,MD; André Vincentelli 1,2,MD, PhD; Jean Dallongeville 3,MD,PhD; Hélène Eltchaninoff 5,MD; Marc Laskar 6,MD; Pascal Leprince 7,MD; Michel Lievre 8,MD, PhD; Carlo Banfi 1,2,MD,PhD; Jean-Luc Auffray1,2,MD; Cedric Delhaye1,2, MD; Gilles Lemesle 1,2,MD; Guillaume Schurtz 1,2,MD; Christopher Hurt 1,2,MD; Flavien Vincent 1,2,MD; Bérénice Marchant1,2,BsC; Nicolas Debry 1,2,MD; Patrick Donzeau-Gouge 9,MD; Karine Chevreul 10,MD,PhD; Jean Fajadet 11,MD; Alain Leguerrier 12,MD; Alain Prat 1,2,MD; and Martine Gilard 13,MD; for the FRANCE 2 Investigators.
1-Departments of Cardiology, University Hospital;
2-EA2693, Lille-II-University;
5-CHU Rouen;
6-CHU Dupuytren, Limoges;
7-CHU Pitié–Salpêtrière, Paris;
8-University Lyon-1;
9-Institut cardiovasculaire Paris-Sud;
11-Clinique Pasteur, Toulouse;
12-CHU Rennes;
13-CHU Brest;
14-CHU Mondor Créteil, France.


Patients with diabetes-mellitus and aortic stenosis (AS) have a poor clinical outcome after surgical valve replacement. Our purpose was to investigate the impact of diabetes-mellitus on the outcome of patients with AS undergoing TAVR.
3,195 consecutive patients planned for TAVR in 34 French centers were prospectively included in the France2 registry. Baseline clinical and echocardiography (TTE) data, post-procedural TTE and clinical follow-up (306 days(IQR=178-490) were prospectively recorded.
The outcome of diabetic vs non-diabetic patients, including the primary endpoint of death and/or stroke at 1-year, was analyzed in the overall population and according to device technology and delivery route.
Diabetic patients (n=797,24.9%) were younger (p<0.0001), more likely men (p=0.005), with a lower LVEF (p=0.01), more comorbidities and a higher median STS score (p<0.00001). The higher risk profile of diabetic patients was still present after adjustment on age, gender and BMI.
Post-procedural Aortic-Regurgitation≥grade2 was lower (11.8%vs17.1%,p=0.001) and “device success” was higher (86.9%vs82.7%, p=0.005) in diabetic compared to non-diabetic patients. These results were confirmed after multivariable adjustment and were independent of device technology and delivery-route.
The primary endpoint of death and/or stroke at 1-year was lower in diabetic compared to nondiabetic patients(19.7%vs23.1%, p=0.04), was confirmed after multivariable adjustment and irrespective of device technology. An interaction-term was found between diabetes-mellitus, delivery approach and clinical outcome. In patients undergoing “femoral”-TAVR, the rate of death and/or stroke at 1-year was similar in diabetic and non-diabetic patients (19.9% vs 20.6%,p=0.67). In diabetics undergoing “nonfemoral”-
TAVR it was lower than in non-diabetic patients (19% vs 30.3%,p=0.001) and in the same magnitude than in patients undergoing “femoral”-TAVR.
Despite a higher risk profile, diabetics with AS undergoing TAVR, have a favorable outcome compared to non-diabetics. Furthermore diabetics undergoing “non-femoral”-TAVR do not have the extra-risk usually associated with this approach. These data suggest also that TAVR could become the treatment of choice of high-risk diabetic patients with AS.

Association between beta blockers and outcomes in patients with heart failure and preserved ejection fraction

Lars LundBy Lars Lund, (Stockholm, Sweden)
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LH. Lund 1, L. Benson 2, U. Dahlstrom 3, M. Edner 2, L. Friberg 2
(1) Karolinska University Hospital, Department of Cardiology, Stockholm, Sweden
(2) Karolinska Institute, Department of Medicine, Cardiology Unit, Stockholm, Sweden
(3) Linkoping University, Medicine, Linkoping, Sweden


Heart failure with preserved ejection fraction (HFPEF) may be as common and as lethal as heart failure with reduced ejection fraction (HFREF). Beta-blockers reduce mortality in HFREF but are inadequately studied in HFPEF.
To test the hypothesis that beta-blockers are associated with reduced all-cause mortality in HFPEF.
Prospective propensity score matched cohort study using the Swedish Heart Failure Registry; patients registered between 1 July 2005 and 30 December 2012; follow-up until 31 December 2012; median 755 days; no patients lost to follow-up.
Setting: Nationwide registry of 67 hospital in- and out-patient units and 95 out-patient primary care clinics in Sweden.
Consecutive sample of 41,976 patients.  Of these, 19,083 patients with HFPEF (mean±SD age 76±12, 46% women), of which 8,244 were matched 2:1 based on age and propensity score for beta-blocker use, yielding 5,496 treated and 2,748 un-treated patients with HFPEF, and a “positive control” consistency analysis in 22,893 patients with HFREF, of which 6,081 were matched yielding 4,054 treated and 2,027 un-treated patients with HFREF. Propensity scores were derived from 52 baseline clinical and socioeconomic variables.
Beta-blocker at discharge from hospital or out-patient visit; beta-blocker use followed for duration of study, analyzed intention-to-treat and per-protocol with censoring at cross-over.
Outcomes: The pre-defined outcomes were: primary outcome all-cause mortality; secondary outcome: combined all-cause mortality or heart failure hospitalization.
In the matched HFPEF cohort, one-year survival was 80% vs. 79% for treated vs. un-treated patients, and 5-year survival was 45% vs. 42%, with 177 vs. 191 deaths per 1,000 patient-years, hazard ratio (HR) 0.92 (95% CI 0.86-0.99, p=0.021) (FIGURE). Beta-blockers were not associated with reduced combined HF hospitalization or mortality (HR 0.98, 95% CI 0.92-1.03, p=0.422). In the matched HFREF cohort, the HR for mortality was 0.90 (0.83-0.97, p=0.008) and beta-blockers were also associated with reduced combined mortality or HF hospitalization (HR 0.90, 95% CI 0.84-0.95, p=0.001).
Conclusion and Relevance
In patients with HFPEF, use of beta-blockers was associated with reduced all-cause mortality but not combined all-cause mortality or HF hospitalization. Beta-blockers in HFPEF should be examined in a large randomized controlled trial.

Adherence to clinical practice guidelines: examining reasons for variation across OECD countries - results from the long term european society of cardiology heart failure registry

Aldo Pitro Maggioni, FESCBy Aldo Pietro Maggioni, FESC (Florence, Italy)
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A P. Maggioni 1, N. Klazinga 2, N. Biondi 2, R. Urso 1, K. Van Gool 3, N. Maniadakis 4, L. Tavazzi 5
(1) ANMCO Research Center, Florence, Italy
(2) Organisation for Economic Cooperation and Development (OECD), Paris, France
(3) University of Technology, Centre for Health Economics Research and Evaluation, Sydney, Australia
(4) School of Public Health , Health Services Organisation & Management National, Athens, Greece
(5) Maria Cecilia Hospital - GVM Care&Research , E.S. Health Science Foundation, Cotignola, Italy


The burden of heart failure (HF) is considerable in most countries. HF is a complex condition that requires extensive monitoring and treatment involving multiple providers and health care institutions leading to high health care use and costs. Despite the potential for practice guidelines to improve health care outcomes, there is evidence that they are adopted too slowly or are applied inconsistently. This often leads to suboptimal care and fails to deliver further improvements in the quality of care and health outcomes. Lack of adherence could be due to patient characteristics, contraindications or comorbidities, but may also relate to socio-economic variables including costs and access to care as well as the patient’s perceived benefits of care.
Main purpose
It seemed particularly attractive to evaluate not only the role of clinical variables on the adherence to the recommendations of current guidelines but also that of variables describing the health structure/organization of different countries.
To undertake the analysis, three different sources of data were combined: the ESC’s Heart Failure Long-Term Registry, the OECD’s Health System Characteristics Survey and the OECD Health Statistics 2013 Database. The ESC’s Heart Failure Long-Term Registry is a prospective observational study, conducted in 32 ESC countries. The Registry tried to reflect ‘real-world’ management from a variety of hospitals, of all levels of complexity. Currently, reports of trials or registries concerning treatments of patients with HF, as well as in other conditions, quantitatively define the use of guideline-recommended drugs, usually as the proportion of patients who received these treatments.
In the ESC Long-Term Registry detailed information has been obtained not only on patient characteristics and the use of procedures and treatments, but also on the reasons why recommended pharmacological treatments were not appropriately utilized in patients with HF. This information has generally not been available from previous administrative datasets, trials, or registries. The OECD Health System Characteristics survey collects information on a wide range of health system characteristics including coverage of health services and products, provider payment systems, health care financing arrangements, provision of health care and governance structures. Fifteen variables related to access, resources and quality were selected for the analysis and used as "group-level" variables.
For drug treatment of patients with heart failure and reduced ejection fraction, non-adherence to ESC guidelines was defined as all patients: - not treated with at least one of the 2 recommended treatments (ACE-Inhibitors-ARBs and beta-blockers); or - treated with both ACE-Inhibitors/ARBs and beta-blockers, but with a dosage of at least 1 of the 2 drugs with less than 100% of the recommended dosage; and - absence of a documented contraindication or intolerance.
Multiple logistic regression was performed including patient-level variables only and using a conventional stepwise variable-reduction technique. After the best set of patient-level covariates was identified in the (single-level) multiple logistic regression and, the variable that defines the clusters ("country") was introduced to test the suitability of a multilevel model as the nature of the data is hierarchical with patients nested within countries. The association between non-adherence and each covariate was calculated using odds ratios (OR) with 95% confidence intervals (CI).
The results of the ESC-OECD Project will be formally presented for the first time at the ESC Congress.




Registry Hot Line: Valves and heart failure

The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.


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