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Registry Hot Line: Interventions, devices and outcomes

ESC Congress 2014 - Hot Line report

Resources are published as they become available during ESC Congress



Reduction in office blood pressure after renal denervation in a large real world patient population with uncontrolled hypertension: interim results from the Global SYMPLICITY Registry

By Felix Mahfoud, (Homburg/Saar, Germany)
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Authors:
F. Mahfoud 1, G. Mancia 2, M. Schlaich 3, K. Narkiewicz 4, L. Ruilope 5, R. Schmieder 6, M. Bohm 1
(1) Saarland University Hospital, Homburg, Germany (2) University of Milan-Bicocca, Milan, Italy (3) Baker IDI Heart and Diabetes Institute, Melbourne, Australia (4) Medical University of Gdansk, Department of Hypertension and Diabetology, Gdansk, Poland (5) University Hospital 12 de Octubre, Madrid, Spain (6) University of Erlangen-Nuremberg, Department of Nephrology and Hypertension, Erlangen, Germany

Abstract

Purpose
To examine the safety and effectiveness of renal denervation in a large real-world patient population with uncontrolled hypertension and/or other diseases characterized by elevated sympathetic drive.
Methods
The Global SYMPLICITY Registry (GSR) will enroll ≥5,000 patients at over 200 sites. Patient selection, treatment and follow-up to 5 years are according to local practice. Analysis includes safety in the first 1000 consecutively enrolled patients and change from baseline in office and 24-hour ambulatory blood pressure (BP) for the subgroup with severe, resistant hypertension.
Results
Among patients with baseline office systolic BP (SBP) ≥160 mm Hg and ambulatory SBP ≥135 mm Hg receiving ≥3 antihypertensive medications ( n=327), baseline office BP and 24-hour ambulatory SBP measurements are shown (Table). Mean age was 61 ± 11 years, 64% were men, mean body mass index was 31 kg/m2, 45% had a history of diabetes, and 28% had renal impairment (defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2). The mean number of antihypertensive medication classes at baseline was 4.7 ± 1.2. Office SBP and diastolic BP (DBP), and 24-hour ambulatory SBP significantly decreased at both 3 and 6 months (p<0.0001 for all values, Table). At 6 months, 68.4% had a reduction in office SBP >10 mmHg; 18.0% had controlled office SBP (≤140 mmHg). The incidence of peri-procedural complications was low in the total population (n=913): 2 (0.22%) renal artery re-interventions, and 4 (0.44%) vascular complications. Adverse events through 6 months included 4 (0.44%) deaths, 2 (0.22%) development of new end stage renal disease (1 with pre-existing renal insufficiency and 1 due to suicide), and 9 (.99%) hospitalizations for hypertensive crises. There were no cases of new renal artery stenosis >70%.
Conclusions
In this "real world" patient population, patients in the GSR with BP inclusion criteria matching those of SYMPLICITY HTN-3 demonstrated a substantial reduction in office and ambulatory SBP after RDN with a favorable safety profile. Complete 12 month follow-up results in the first 1000 enrolled patients plus 6 month follow-up of 1500 patients and correlates for response will be reported in August.

SCAAR: Lower late and very late stent thrombosis rates with new generation drug eluting stents compared to bare metal stents

Christoph VarenhorstBy Christoph Varenhorst, (Uppsala, Sweden)
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Authors:
C. Varenhorst (1), G. Sarno (2), G. Olivecrona (3), P. Tornvall (4), J. Nilsson (5), J. Carlsson (6), S. James (2), B. Lagerqvist (2)
(1) Dept of Medical Sciences, Cardiology, Uppsala, Sweden (2) Uppsala Clinical Research Center and Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden (3) Lund University, Department of Cardiology, Lund, Sweden (4) Karolinska Institute, Södersjukhuset, Stockholm, Sweden (5) Umea University, Department of Cardiology, Heart Centre, Umea, Sweden (6) Kalmar County Hospital, Department of Internal Medicine, Kalmar, Sweden

Abstract

Purpose
Old-generation drug eluting coronary stents (o-DES) have despite being safe and effective been associated with an increased propensity of late stent thrombosis (ST). We evaluated late and very late ST rates in o-DES, new generation DES (n-DES) and bare metal stents (BMS).
Methods
We evaluated all implantations with BMS, o-DES (Cordis Cypher, Boston Scientific Taxus Liberté and Medtronic Endeavor) and n-DES in the Swedish coronary angiography and angioplasty registry (SCAAR) between 1 January 2007 and 8 January 2014 (N= 177488). All cases of ST (N=1969) until 8 January 2014 were analyzed.
Results
The overall risk of ST was lower in both n-DES and o-DES compared with BMS up to one year (n-DES vs BMS: adjusted risk ratio (RR) 0.50 (0.41-0.59) and o-DES vs BMS: 0.55 (0.46-0.67), both p<0.001). From one year after stent implantation and onward, the risk for ST was higher in o-DES compared with BMS (adjusted RR, 1.81 (1.44-2.28), p<0.001). N-DES were associated with similar low ST rates as BMS from one year and onward (adjusted RR 1.17 (0.88-1.56), p=0.279).
Conclusions
New generation DES were associated with both lower late and very late ST rates compared to BMS and o-DES. 

Relation between Hospital Procedure Volume und Complications in Pacemaker Implantation - Results of 430.416 implantations in a nationwide obligatory external quality control program

Bernd NowakBy Bernd Nowak, FESC (Frankfurt Am Main, Germany)
Authors:
B. Nowak 1, K. Tasche 2, L. Barnewold 2, G. Heller 2, KJR Chun 1, B. Schmidt 1
1-Cardioangiologisches Centrum Bethanien, Frankfurt, Germany
2-Aqua-Institute, Göttingen, Germany

Abstract

Purpose/Background
Several studies demonstrated a relationship between hospital ICD implantation volume and complication rate. It is not clear, whether such a relation exists for pacemaker therapy as well, especially regarding gender effects.
Aim of this study was therefore, to evaluate in a contemporary population, whether hospital pacemaker implantation volume and procedural complications are related.
Methods
The database of the obligatory external quality control program in Germany was evaluated retrospectively for the years 2007 – 2012. We analysed mean annual hospital implantation volume and in-hospital complications for primary pacemaker implantation.
Results
Overall 430,416 in-hospital implantations have been performed in 1,226 hospitals. Mean age of the patients was 75.9 ± 10.5 years (53.4 % male). Implanted systems have been: Dual-chamber pacemakers in 73.5 %, Single-chamber pacemakers in 26.1 % and CRT-P systems in 1.1 %. Total in-hospital complication rate was 0.99 % for surgical complications,  0.92 % for ventricular lead dislocation, and 1.22 % for atrial lead dislocation. For comparison, we stratified the hospitals by quintiles of annual pacemaker implantations.


Conclusion
Primary pacemaker implantation in hospitals with lower implantation volume was associated with a significantly higher rate of surgical complications and lead dislocations for both genders, although implantation rates of complex systems were lower. Surgical complications and ventricular lead dislocations occured more frequently in women, while men experienced more atrial lead dislocations.

Major improvement in one-year mortality in elderly patients admitted with AMI in relation with early PCI and recommended medications: data from the FAST-MI programme 1995-2010

By Etienne Puymirat, (Paris, France)
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Authors:
E. Puymirat 1, F. Schiele 2, M. Elbaz 3, M. Hanssen 4, P. Henry 5, J. Ferrieres 3, P. Gueret 6, T. Simon 7, N. Danchin 1
(1) AP-HP - European Hospital Georges Pompidou, Paris, France (2) Regional University Hospital Jean Minjoz, Besancon, France (3) Rangueil Hospital of Toulouse, Toulouse, France (4) Centre Hospitalier, Haguenau, France (5) Hospital Lariboisiere, Paris, France (6) University Hospital Henri Mondor, Creteil, France (7) AP-HP - Hospital Saint Antoine, Paris, France

Abstract

Background and aim
Comparatively few elderly patients (≥75 years) have been included in randomized trials in the setting of acute myocardial infarction (AMI). Whether recommended management such as used in younger patients has led to similar improvements in outcomes remains an open question.
Methods
USIK 1995, USIC 2000, FAST-MI 2005 and FAST-MI 2010 are 4 nationwide French surveys conducted with a similar methodology and including all patients admitted to cardiology departments of general, academic or private hospitals for STEMI or NSTEMI with symptom onset ≤ 48 hours during a one-month period. Of the 10610 patients included, 3389 were ≥75 years of age (1995: 683; 2000: 684; 2005: 1062; 2010: 960). The proportion of NSTEMI (1995: 33%, 2000: 25%, 2005: 58%, 2010: 54.5%) increased after 2000 because of the widespread use of troponins.
Results
From 1995 to 2010, mean age remained stable (82 ± 5 years) and was similar in STEMI and NSTEMI patients. Obesity (9% to 15%), diabetes (20.5 to 30%), hypertension (58% to 75%), and hypercholesterolemia (27.5% to 43%) increased. History of prior MI (21% to 23%), prior stroke (10% to 9%) and peripheral artery disease (15% to 13%) remained stable, while history of heart failure decreased (19% to 10%, P<0.001). Major changes in management were noted: PCI ≤ 72 hours of admission increased from 6% to 55%; early treatment with antiplatelet agents (86% to 97%), low molecular weight heparin (0 to 51%), beta-blockers (40% to 71%), ACE-I or ARB (46% to 60.5%) and statins (4% to 81%) all significantly increased. One-year mortality (Fig 1) decreased from 36% to 20% (HR adjusted on baseline characteristics 2010 vs 1995: 0.50, 0.41-0.61, P<0.001), both for STEMI (from 37% to 21%) and NSTEMI (from 35% to 19%). Study period, however was no longer associated with decreased mortality when variables reflecting management changes were entered into the multivariate analysis (HR 2010 vs 1995: 1.04, 0.78-1.38); compared with patients with no early PCI or low molecular weight heparin, a decreased risk of 1-year death was observed for PCI and LMWH (HR 0.31, 0.22-0.43, P<001), PCI and no LMWH (HR 0.68, 0.53-0.87, P=à.002) and LMWH without PCI (HR 0.76, 0.62-0.93, P=0.009)(Fig 2). Decreased 1-year death was also associated with early beta-blocker (HR 0.48, 0.41-0.56, P<0.001), ACE-I (HR 0.81, 0.70-0.94, P=0.007) and statin therapy (HR 0.83, 0.69- 1.00, P=0.049).
Conclusion
One-year mortality of elderly patients with AMI has dramatically decreased over the past 15 years. This improvement can be explained by increasing use of early PCI, newer anticoagulants and recommended medications.

Prospective multicenter evaluation of a 1h-algorithm in the diagnosis of myocardial infarction using high-sensitivity cardiac Troponin T

Christian Mueller, FESCBy Christian Mueller, FESC (Basel, Switzerland)
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Authors:
C. Mueller 1, E. Giannitsis 2, M. Christ 3, J. Ordonez-Llanos 4, C R. Defilippi 5, R M. Nowak 6, R. Body 7, M. Panteghini 8, T. Jernberg 9, B. Lindahl 10
(1) University Hospital Basel, Department of Cardiology, Basel, Switzerland (2) University Hospital of Heidelberg, Heidelberg, Germany (3) Community Hospital Nuremberg, Department of Emergency and Critical Care Medicine, Nuremberg, Germany (4) Institut d'Investigacions Biomèdiques Sant Pau, Department of Clinical Biochemistry, Barcelona, Spain (5) University of Maryland School of Medicine, Department of Medicine, Baltimore, United States of America (6) Henry Ford Hospital, Detroit, United States of America (7) University of Manchester, Cardiovascular Sciences Research Group, Manchester, United Kingdom (8) University of Milan Medical School, Department of Biomedical and Clinical Sciences 'Luigi Sacco', Milan, Italy (9) Karolinska Institute, Department of Medicine, Stockholm, Sweden (10) Uppsala University, Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala, Sweden

Abstract

Background
We aimed to prospectively validate the performance of a novel 1h-algorithm using high-sensitivity cardiac troponin T (hs-cTnT) for the early rule-out and rule-in of acute myocardial infarction (AMI).
Methods
We enrolled 1282 unselected patients presenting with suspected AMI and recent (<6h) onset of symptoms to the emergency department. Hs-cTnT and s-cTnI ultra were measured at study inclusion (T0), and after 1h, 2h and 4- 14h. The final diagnosis was centrally adjudicated by two independent cardiologists using all available information including coronary angiography, echocardiography, follow-up data, and serial measurements of s-cTnI ultra, while adjudicators remained blinded to hs-cTnT.
Results
AMI was the final diagnosis in 16.6% of patients. Applying the predefined hs-cTnT 1h-algorithm, 813 (63.4%) patients were classified as "rule-out", 184 (14.3%) patients were classified as "rule-in" and 285 (22.2%) patients were classified in the "observational zone". Overall, this resulted in a negative predictive value for AMI of 99.1% (95% CI, 98.2-99.7%) in the "rule-out" zone, a positive predictive value for AMI of 77.2% (95% CI, 70.4-83.0%) in the "rule-in" zone, and a prevalence of AMI of 22.5% in the "observational" zone. Cumulative 30-days mortality was 0.1%, 0.7% and 2.7% (p<0.001, log-rank test) in patients classified as "rule-out", "observational zone" and "rule-in".
Conclusions
The hs-cTnT 1h-algorithm performs well for early rule-out as well as rule-in of AMI. Used in conjunction with all other clinical information including ECG, the 1h-algorithm will be a safe and effective approach to substantially reduce time to diagnosis.

ELECTRa (European Lead Extraction ConTRolled) Registry: preliminary data on transvenous lead extraction in europe

Maria Gracia Bongiorni, FESCBy Maria Grazia Bongiorni, FESC (Pisa, Italy)
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Authors:
M G. Bongiorni 1, C. Kennergren 2, C. Butter 3, J C. Deharo 4, A. Kutarski 5, C A. Rinaldi 6, A P. Maggioni 7, C. Blomstrom-Lundqvist 8, A. Auricchio 9, K H. Kuck 10
(1) Santa Chiara Hospital, Cardiovascular Diseases Unit 2, Pisa, Italy (2) Sahlgrenska University Hospital, Department of Cardiothoracic Surgery, Goteborg, Sweden (3) Brandenburg Heart Center, Bernau Bei Berlin, Germany (4) Hospital La Timone of Marseille, Arrhythmias Unit, Department of Cardiology, Marseille, France (5) Medical University of Lublin, Department of Cardiology, Lublin, Poland (6) St Thomas' Hospital, Department of Cardiology, London, United Kingdom (7) European Society of Cardiology , EORP department, Sophie Antipolis, France (8) Uppsala University, Department of Cardiology, Istitution of Medical Science, Uppsala, Sweden (9) Cardiocentro Ticino, Division of Cardiology, Lugano, Switzerland (10) Asklepios Clinic St. Georg, Department of Cardiology, Hamburg, Germany

Abstract

Background
In the recent years, the number of cardiac rhythm devices implant procedures has significantly increased as well as the number of complications related to these devices leading to a higher number of Transvenous Lead Extraction (TLE). Several European centers started to implement this procedure, albeit consistent and objective data concerning indication, success rate and safety of TLE are still lacking.
Study Design and methods
This Registry is a large, prospective, multicentre registry of patients undergoing TLE in ESC countries. Its primary objective is to evaluate the acute and long-term safety of TLE; secondary objectives include the description of patient characteristic, leads, indications for TLE and techniques currently used for this procedure as well as the assessment of the outcomes of TLE procedures and the complication rate comparison between low and high volume centres (high volume > 2.5 pts/month and low volume Centres < = 2.5 pts/month).
Recruitment of patients started on November 2012 and ended on June 2014. The Data were collected using a web based system and audited at random centers. No specific protocol for the procedure, materials, techniques of extraction, or treatment after the procedure was mandatory during this observational study. Patients will be also followed up to 1 year.
Results
Seventy-five hospitals, from 19 different Countries, enrolled 3524 patients. The 72% of the patients were male, with a mean age of 65 years. Fifty-three percent of patients had hypertension and 22% had diabetes. Patients had different type of devices and their representative percentages were: 38.1% had dual chamber pacemaker, 16.4% dual chamber defibrillator, 16.7% CRT defibrillator, 3.5% CRT pacemaker, 9.9% single chamber pacemaker, 14% single chamber defibrillator, 1% other pacing systems, 0.2% other defibrillating systems, 0.2% had no generators but only abandoned leads. Infections were 52.7% of cases, not infective indications were 47.3%. A total of 6433 leads were extracted, whose 3316 were from Pacemaker-implanted patients and 3105 from ICD patients, 12 were abandoned leads in patients without generator. Data demonstrated major complications in 2.7%: 2.5% for high volume centres while 3.9% for low volume centres. Death rate was 1.4%: 1.2% in high volume centres and 2.5% in low volume centres.
The percentage of the complete success, defined as complete extraction and clinical success was 95.5%, the clinical success even without complete lead extraction was 2.8%, the complete radiological success without clinical success was 0.2% and the failures were 1.5%.
Conclusions
The information collected in the Survey will allow getting a description of the European practice on TLE, a comparison of data between low and high volume centres. This information will be very useful to increase the quality of care in the lead extraction process and to verify and improve the standards for TLE procedures.

Prospective Registry Of Patients Using The Wearable Defibrillator (WEARIT-II Registry)

Valentina KutyifaBy Valentina Kutyifa, FESC (Rochester, United States of America)

Authors:

Valentina Kutyifa, MD, PhD, Ilan Goldenberg, MD, Wojciech Zareba, MD, PhD, Helmut Klein, MD, Chingping Wan, MD, Bonnie MacKecknie, Mark L. Andrews, MS, Steve Szymkiewicz, MD and Arthur J. Moss, MD. University of Rochester Medical Center - Heart Research Follow-up Program, Rochester, NY, ZOLL, Pittsburgh, PA

Abstract

Background
Patients with a high risk for sudden cardiac death and potentially eligible for an implantable cardioverter defibrillator (ICD) may present with a transient arrhythmic risk. In these patients, the Wearable Cardioverter Defibrillator (WCD) provides continuous arrhythmia monitoring and defibrillation of a potentially fatal ventricular tachyarrhythmia. The WEARIT-II Registry was designed to provide prospective data on the safety and efficacy of the WCD.
WEARIT-II is a prospective Registry that enrolled 2000 patients prescribed the WCD. Clinical data, arrhythmia events and need for ICD implantation after termination of WCD usage were captured. The study was approved by the Institutional Review Board and all patients provided written informed consent.
Results
Between August 2011 and February 2014, 2000 patients who were prescribed a WCD in the US were enrolled in the Registry. The median age was 62 years, median left ventricular ejection fraction 25%, and 30% of the enrolled patients were women. Congenital and/or inherited heart disease comprised 13.4% (n=268) of the patients; 805 (40.3%) patients with acquired heart disease had ischemic cardiomyopathy, and 927 patients (46.4%) had cardiomyopathy of non-ischemic etiology. The median WCD wear time was 90 days with a median daily use of 22.5 hours. Arrhythmia events during WCD use are presented in the Table below. There were a total number of 120 sustained ventricular tachyarrhythmia events in 41 patients, corresponding to a rate of 22 sustained episodes per 100 patient-years (Table), whereas the rates of inappropriate WCD therapy (0.5 % or 2 events per 100 patient-years) was very low. At the end of WCD use, ICD was implanted in 794 of the 2000 patients. The most frequent reason not to implant an ICD following WCD wear was improvement in left ventricular ejection fraction (40%).
Conclusion
Our findings from the WEARIT-II Registry demonstrate that WCD is safe and useful to bridge a period of risk assessment in order to avoid unnecessary ICD implantation, most often because of significant improvement in left ventricular ejection fraction, in a real world setting.

References


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Registry Hot Line: Interventions, devices and outcomes

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.