Cardiac Resynchronisation Therapy Survey II

An initiative undertaken by the HFA (Heart Failure Association) and EHRA (European Heart Rhythm Association)

CRT is a potent adjunct therapy to heart failure medication, which reduces mortality and morbidity in patients with heart failure with electrical dyssynchrony (1, 2). CRT receives strong recommendations for treatment and levels of evidence in current guidelines (3,4). In spite of these recommendations and the expanding indications for CRT to include patients in NYHA II heart failure, the increase in the rate of CRT has been modest across Europe.

The CRT Survey II, a joint initiative of EHRA and HFA, is progressing well. Investigators have entered >4,500 patients. We will continue until we have more than 11,000 patients.

Cardiac Resynchronisation Therapy

There are large regional and national differences as reported in the results from the 2013 EHRA White Book (5). There are numerous explanations for this such as lack of funding, limited referrals, relatively few CRT implantation centers and an unawareness of the indications for CRT amongst non-heart failure or arrhythmia specialties. Therefore, actions to increase the awareness of the indications for CRT as well as to increase both the quality and level of care for follow-up over EHRA countries are needed. A representative survey creates benchmarking possibilities within and between countries and between different regions in Europe. Ultimately such knowledge may specifically highlight the need for better resources and referral systems and increase CRT availability for appropriate patients.

History

The first CRT Survey from 2008/2009 (6-9) included 13 countries and encompassed 2438 patients. The results demonstrated important differences in practice between countries and showed that implanters were exploring wider indications with frequent implantations in the elderly and in patients with atrial fibrillation or a narrow QRS duration. Many implantations were device upgrades. The Survey reflected real-life practice in patients not usually included in randomized clinical trials.(9). The results from the first CRT Survey received much attention, had a substantial impact on clinical discussions and the publications were frequently cited (6-9).

What is the CRT Survey II

The two ESC associations, EHRA and HFA planned a more extensive Survey CRT Survey II with an improved design based on experience from the first Survey, and greatly simplified electronic case report form. CRT Survey II began collecting data on 1^st October 2015 and is currently is operating in 40 countries. The Associations found it important to perform this second survey in view of our increased understanding of the expanding indications for CRT and the steady improvement in technology and care delivery.

The CRT Survey II is a 6-month, snapshot survey designed to describe clinical practice regarding implantation of Cardiac Resynchronisation Therapy (CRT) devices in a broad sample of hospitals in >40 ESC member countries. The large-volume of clinical and demographic data collected should reflect current patient selection, implantation and follow-up practice and provide information relevant for assessing healthcare resource utilisation in connection with CRT. The findings of this Survey will permit benchmarking between centres and countries across Europe. Moreover, the Survey may help to identify the major obstacles to implementation of CRT therapy and thus create a basis for enhancement of therapy access.

How to get involved

As an HFA or EHRA member, you can play an important role in ensuring that the Survey is representative across Europe as well as in your own country.

If you would like to participate in this highly important initiative that will help identify implantation patterns and define what actions need to be taken to overcome potential challenges:

Please contact operations at: tessa.baak.norway@gmail.com

00 47 452 07412

How it works

The Scientific Committee includes both Boards’ leadership as well as opinion leaders in the field and representatives of all five device companies. As in the first Survey, data collection and management will be performed by the Institut fur Herzinfarkforschung (IHF) in Ludwigshafen, Germanywith internet-based data collection. Each country enrolled in the Survey has a single national coordinator, selected by the corresponding National Cardiology Society. The National Coordinator’s role is to recruit centres and implanters and facilitate the successful performance of the Survey. Each country will retain the rights to publish on their national data and benchmark internationally. The National Coordinators will have responsibility for the publication process of their national data. A list of National coordinators is found at the end of the newsletter. Patients enrolled will be both those with new implantations of a CRT-P/CRT-D and upgrades.

There is a one-time,site description questionnaire completed by each site prior to inclusion of the first patient. This information describes the organisation of the device programme at each site and provides information useful for assessing health resource utilisation. Description of hospital type, the number and type of invasive procedures and device implantations performed, the number and speciality of implanting physicians and the follow-up options and routines provided for patients receiving CRT devices are entered.

The second and patient related eCRF is completed at each enrolment. This eCRF includes only essential information such as patient demographics, aetiology of heart failure, pharmacological therapy, EKG morphology and QRS duration, indication for CRT implantation, procedural details including LV lead position, device programming as well as discharge status, important peri-or post procedural complications and follow-up plans. Importantly and in contrast to the first CRT Survey, data from unsuccessful CRT implantations will also be included and identify obstacles for successful implantations of the LV lead. There is no follow-up after discharge from hospital.

Aspirations

This CRT Survey II should reflect changes in clinical practice due to the substantial modifications in ESC device guideline recommendations by both the HFA and EHRA (3,4). These recommendations emphasize the importance of QRS duration and morphology, appropriate patient selection and provide new indications for CRT such as in patients requiring conventional permanent pacemakers. We believe that CRT Survey II will give valuable information to the clinical cardiology community regarding CRT implantations in Europe and permit useful benchmarking for clinicians and the device industry as well as administrators responsible for health care resource utilization. Ultimately, we hope that the results will serve to increase CRT implementation for the heart failure patients in Europe.

Scientific committee:

HFA Representatives: Kenneth Dickstein (coordinator), Stefan D.Anker, Piotr Ponikowski, Gerasimos Filippatos, John Cleland, Frank Ruschitzka, Nigussie Bogale

EHRA Representatives, Cecilia Linde (coordinator), Karl-Heinz Kuck , Gerhard Hindricks,Angelo Auricchio, Carina Blomström Lundqvist, Christoph Stellbrink, Maurizio Gasparini

IHF Anselm Gitt

Cardiology fellow Camilla Normand

Industry representatives:

Medtronic, Boston Scientific, St. Jude, Biotronik, Sorin, Abbott Laboratories, Servier

References

Cleland JG, Abraham WT, Linde C, Gold MR, Young JB, Daubert JC, Sherfesee L, Wells GA, Tang ASL. An individual patient meta-analysis of five randomized trials assessing the effects of cardiac resynchronisation therapy on morbidity and mortality in patients with symptomatic heart failure. Eur Heart J 2013; 46:3547-56
Woods B, Hawkins N, Mealing S, Sutton A, Abraham WT, Beshai JF, Keliin H, Sculpher M, Plummer CJ, Cowie MR. Individual patient data network meta-analysis of mortality effects of implantable cardiac devices. Open Heart 2015; 22:1800-1806
McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Böhm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Køber L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Rønnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology, Bax JJ, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Kirchhof P, Knuuti J, Kolh P, McDonagh T, Moulin C, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Torbicki A, Vahanian A, Windecker S, McDonagh T, Sechtem U, Bonet LA, Avraamides P, Ben Lamin HA, Brignole M, Coca A, Cowburn P, Dargie H, Elliott P, Flachskampf FA, Guida GF, Hardman S, Iung B, Merkely B, Mueller C, Nanas JN, Nielsen OW, Orn S, Parissis JT, Ponikowski P; ESC Committee for Practice Guidelines.ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2012; 14:803-869.
2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: The Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Authors/Task Force Members, Brignole M, Auricchio A, Baron-Esquivias G, Bordachar P, Boriani G, Breithardt OA, Cleland J, Deharo JC, Delgado V, Elliott PM, Gorenek B, Israel CW, Leclercq C, Linde C, Mont L, Padeletti L, Sutton R, Vardas PE; ESC Committee for Practice Guidelines (CPG), Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers, Kirchhof P, Blomstrom-Lundqvist C, Badano LP, Aliyev F, Bänsch D, Baumgartner H, Bsata W, Buser P, Charron P, Daubert JC, Dobreanu D, Faerestrand S, Hasdai D, Hoes AW, Le Heuzey JY, Mavrakis H, McDonagh T, Merino JL, Nawar MM, Nielsen JC, Pieske B, Poposka L, Ruschitzka F, Tendera M, Van Gelder IC, Wilson CM. Europace. 2013 ;15:1070-1118.
Raatikainen MJP, Arnar DO, Zeppenfeld K, Merino JL, Levya F, Hindricks G, Kuck KH. Statistics on the use of cardiac electronic devices.and electrophysiological procedures in the European Society of Cardiology countries. 2014 report from the European Heart Rhythm Association. Europace 2015;i7-i75.
Dickstein K, Priori S, Auricchio A, Brugada J, Cleland J, Derumeaux G et al.European Cardiac Resynchronization therapy survey: rationale and design. The CRT Survey Scientific Committee Eur J Heart Fail 2009;11:326-330.
Dickstein K, Bogale N, Priori S, Auricchio A, Cleland J, Gitt A, Limbourg T, Linde L, van Veldhuisen DJ, Brugada J On behalf of the Scientific Committee and all National Coordinators. The European Cardiac Resynchronization Therapy Survey Eur Heart J 2009 Oct;30(20):2450-60.
Bogale N, Priori S, Gitt A, Linde C, Dickstein K. Patient selection and implantation practice of CRT devices vary according to center volume; the European CRT Survey. Europace 2011 10:1445-1453
Bogale N, Priori S, Cleland JG, Brugada J, Linde C, Auricchio A, van Veldhuisen DJ, Limbourg T, Gitt A, Gras D, Stellbrink C, Gasparini M, Metra M, Derumeaux G, Gadler F, Buga L, Dickstein K; Scientific Committee, National Coordinators, and Investigator The European CRT Survey: 1 year (9-15 months) follow-up results Eur J Heart Fail. 2012: 1:61-73.
Dickstein K, Normand C, Anker SD, Auricchio A, Blomström CL, Bogale N, Cleland J, Filippatos G, Gasparini M, Gitt A, Hindricks G, Kuck KH, Ponikowski P, Stellbrink C, Ruschitzka F, Linde C. European CRT Survey II, Rationale and design. Europace 2015 ;1:137-41.

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