Clinical and demographic characteristics of patients with congestive heart failure and implanted devices for cardiac resynchronization therapy

Clinical recommendations for cardiac resynchronization therapy (CRT) were based on the results of large multicenter studies. However, patients with congestive heart failure (CHF) in real clinical practice differ from the cohort included in randomized trials. Aim of the study was to evaluate the clinical and demographic characteristics of patients with CHF and implanted devices for CRT in real clinical practice according to the local register of implanted cardiac devices and to compare local cohort with patients included in large clinical trials and registers. Material and methods: The study enrolled 218 patients (83 % men, 17 % women) with CHF implanted with CRT devices from January 2003 to December 2018. Results and discussion: When compared to large studies and registers local cohort was significantly younger (75,9 % of patients were younger than 65 age), the mean age was 57,2 ± 10,5 years. NYHA functional class was lower and left ventricular ejection fraction was higher. However, the distribution of comorbidity was higher, 65 % of patients had ≥3 comorbid conditions. Atrial fibrillation (AF) was observed more frequently (38.5 %). Conclusion: Our data demonstrate significant differences between real clinical cohort and cohort of patients included in large multicenter studies. These differences may significantly affect the effectiveness of CRT both positively (lower age, lower NYHA) and negatively (high distribution of AF and other comorbidities). This explains the need for randomized control CRT studies in Russia and the creation of local registers of CRT devices.

cardiac resynchronization therapy, congestive heart failure

1. Moss A.J., Hall W.J., Cannom D.S., Klein H., Brown M.W., Daubert J.P., Estes N.A. 3rd, Foster E., Greenberg H., Higgins S.L., Pfeffer M.A, Solomon S.D., Wilber D., Zareba W., MADIT-CRT Trial Investigators. Cardiac-resynchronization therapy for the prevention of heart-failure events. N. Engl. J. Med. 2009; 361: 1329–1338. doi: 10.1056/NEJMoa0906431

2. Tang A.S.L., Wells G.A., Talajic M., Arnold M.O., Sheldon R., Connolly S., Hohnloser S.H., Nichol G., Birnie D.H., Sapp J.L., Yee R., Healey J.S., Rouleau J.L., Resynchronization-Defibrillation for Ambulatory Heart Failure Trial Investigators. Cardiacresynchronization therapy for mild-to-moderate heart failure. N. Engl. J. Med. 2010; 363 (25): 2385–2395. doi: 10.1056/nejmoa1009540

3. Cleland J.G.F., Daubert J.C., Erdmann E., Freemantle N., Gras D., Kappenberger L., Tavazzi L., Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N. Engl. J. Med. 2005; 352 (15): 1539–1549. doi: 10.1056/nejmoa050496

4. Ruschitzka F., Abraham W.T., Singh J.P., Bax J.J., Borer J.S., Brugada J., Dickstein K., Ford I., Gorcsan J. 3rd, Gras D., Krum H., Sogaard P., Holzmeister J., EchoCRT Study Group. Cardiac-resynchronization therapy in heart failure with a narrow QRS complex. N. Engl. J. Med. 2013; 369 (15): 1395–1405. doi: 10.1056/nejmoa1306687

5. Young J.B., Abraham W.T., Smith A.L., Leon A.R., Lieberman R., Wilkoff B., Canby R.C., Schroeder J.S., Liem L.B., Hall S., Wheelan K., Multicenter InSync ICD Randomized Clinical Evaluation (MIRACLE ICD) Trial Investigators. Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure. JAMA. 2003; 289 (20): 2685–2694. doi: 10.1001/jama.289.20.2685

6. Bristow M.R., Saxon L.A., Boehmer J., Krueger S., Kass D.A., de Marco T., Carson P., DiCarlo L., DeMets D., White B.G., DeVries D.W., Feldman A.M., Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N. Engl. J. Med. 2004; 350 (21): 2140–2150. doi: 10.1056/nejmoa032423

7. Dickstein K., Bogale N., Priori S., Auricchio A., Cleland J.G., Gitt A., Limbourg T., Linde C., van Veldhuisen D.J., Brugada J., Scientific Committee; National Coordinators. The European cardiac resynchronization therapy survey. Eur. Heart J. 2009; 30 (20): 2450–2460. doi: 10.1093/eurheartj/ehp359

8. Kuznetsov V.A., Kolunin G.V., Kharats V.E., Krinochkin D.V., Rychkov A.Yu., Gorbunova T.Yu., Pavlov A.V., Belonogov D.V., Churkevich T.O. Register of performed operations of cardiac resynchronization therapy. Electronic database, state registration № 2010620077 from 01.02.2010 [In Russian].

9. Achilli A., Turreni F., Gasparini M., Lunati M., Sassara M., Santini M., Landolina M., Padeletti L., Puglisi A., Bocchiardo M., Orazi S., Perego G.B., Valsecchi S., Denaro A. On behalf of the InSync/InSync ICD Italian Registry Investigators. Efficacy of cardiac resynchronization therapy in very old patients: the Insync/Insync ICD Italian Registry. Europace. 2007; 9 (9): 732–738. doi: 10.1093/europace/eum143

10. Dickstein K., Normand C., Auricchio A., Bogale N., Cleland J.G., Gitt A.K., Stellbrink C., Anker S.D., Filippatos G., Gasparini M., Hindricks G., Lundqvist C.B., Ponikowski P., Ruschitzka F., Botto G.L., Bulava A., Duray G., Israel C., Leclercq C., Margitfalvi P., Cano O., Plummer C., Sarigul N.U., Sterlinski M., Linde C. CRT Survey II: a European Society of Cardiology survey of cardiac resynchronisation therapy in 11 088 patients-who is doing what to whom and how? Eur. J. Heart Fail. 2018; 20 (6): 1039–1051. doi: 10.1002/ejhf.1142

11. Chung E.S., Leon A.R., Tavazzi L., Sun J.-P., Nihoyannopoulos P., Merlino J., Abraham W.T., Ghio S., Leclercq C., Bax J.J., Yu C.-M., Gorcsan J. 3rd, Sutton M.S.J., de Sutter J., Murillo J. Results of the predictors of response to CRT (PROSPECT) trial. Circulation. 2008; 117 (20): 2608–2616. doi: 10.1161/circulationaha.107.743120

12. Philippon F., Tang A., Yee R., Champagne J., Villeneuve H., Gulamhusein S., Rinne C., Leather R., Thibault B., Newman D. Cardiac resynchronization therapy: clinical outcomes from the Canadian RESTORE registry. J. Card. Fail. 2003; 9 (5): S52. doi: 10.1016/S1071-9164(03)00357-9

13. Tolosana J.M., Madrid A.H., Brugada J., Sitges M., Bolao I.G., Lozano I.F., Ferrer J.M., Quesada A., Macias A., Marin W., Escudier J.M., Gomez A.A., Alcala M.G., Tamborero D., Berruezo A., Mont L., SPARE Investigators. Comparison of benefits and mortality in cardiac resynchronization therapy in patients with atrial fibrillation versus patients in sinus rhythm (Results of the Spanish Atrial Fibrillation and Resynchronization [SPARE] Study). Am. J. Cardiol. 2008; 102 (4): 444–449. doi: 10.1016/j.amjcard.2008.04.008

14. Fein A.S., Wang Y., Curtis J.P., Masoudi F.A., Varosy P.D., Reynolds M.R., National Cardiovascular Data Registry. Prevalence and predictors of offlabel use of cardiac resynchronization therapy in patients enrolled in the National Cardiovascular Data Registry Implantable Cardiac-Defibrillator Registry. J. Am. Coll. Cardiol. 2010; 56 (10): 766–773. doi: 10.1016/j.jacc.2010.05.025

15. Linde C., Cleland J.G.F., Gold M.R., Daubert J.C., Tang A.S.L., Young J.B., Sherfesee L., Abraham W.T. The interaction of sex, height, and QRS duration on the effects of cardiac resynchronization therapy on morbidity and mortality: an individualpatient data meta-analysis. Eur. J. Heart Fail. 2018; 20 (4): 780–791. doi: 10.1002/ejhf.1133

16. Oganov R.G., Simanenkov V.I., Bakulin I.G., Bakulina N.V., Barbarash O.L., Boitsov S.A., Boldueva S.A., Garganeeva N.P., Doshchitsin V.L., Karateev A.E., Kotovskaya Yu.V., Lila A.M., Luk’yanov M.M., Morozova T.E., Pereverzev A.P., Petrova M.M., Pozdnyakov Yu.M., Syrov A.V., Tarasov A.V., Tkacheva O.N., Shal’nova S.A. Comorbidities in clinical practice. Algorithms for diagnostics and treatment. Kardiovaskulyarnaya terapiya i profilaktika = Cardiovascular Therapy and Prevention. 2019; 18 (1): 5–66. [In Russian]. doi: 10.15829/1728-88002019-1-5-66

17. Belenkov Yu.N., Mareev V.Yu., Ageev F.T., Fomin I.V., Badin Yu.V., Polyakov D.S., Danielyan M.O., Artem’eva E.G., Malenkova V.Yu., Poroshina E.A., Tarlovskaya E.I., Smirnova E.A., Yakushin S.S., Shcherbinina E.V. The true prevalence of CHF in the European part of the Russian Federation (hospital stage). Serdechnaya nedostatochnost’ = Russian Heart Failure Journal. 2011; 12 (2): 63–68. [In Russian]

18. Abraham W.T., Fisher W.G., Smith A.L., Delurgio D.B., Leon A.R., Loh E., Kocovic D.Z., Packer M., Clavell A.L., Hayes D.L., Ellestad M., Messenger J., MIRACLE Study Group. Multicenter InSync Randomized Clinical Evaluation. Cardiac resynchronization in chronic heart failure. N. Engl. J. Med. 2002; 346 (24): 1845–1853. doi: 10.1056/NEJMoa013168

19. Higgins S.L., Hummel J.D., Niazi I.K., Giudici M.C., Worley S.J., Saxon L.A., Boehmer J.P., Higginbotham M.B., de Marco T., Foster E., Yong P.G. Cardiac resynchronization therapy for the treatment of heart failure in patients with intraventricular conduction delay and malignant ventricular tachyarrhythmias. J. Am. Coll. Cardiol. 2003; 42 (8): 1454–1459. doi: 10.1016/S0735-1097(03)01042-8

20. Theuns D.A.M.J., Schaer B.A., Soliman O.I.I., Altmann D., Sticherling C., Geleijnse M.L., Osswald S., Jordaens L. The prognosis of implantable defibrillator patients treated with cardiac resynchronization therapy: comorbidity burden as predictor of mortality. Europace. 2010; 13 (1): 62–69. doi: 10.1093/europace/euq328

21. Singal G., Upadhyay G.A., Borgquist R., Friedman D.J., Chatterjee N.A., Kandala J., Park M.Y., Orencole M., Dec G.W., Picard M.H., Singh J.P., Mela T. Renal response in patients with chronic kidney disease predicts outcome following cardiac resynchronization therapy. Pacing Clin. Electrophysiol. 2015; 38 (10): 1192–1200. doi: 10.1111/pace.12685

22. Daly D.D., Maran A., Hyer J.M., Funke F., Waring A., Cuoco F.A., Sturdivant J.L., Leman R.B., Gold M.R. The effect of chronic kidney disease on mortality with cardiac resynchronization therapy. Pacing Clin. Electrophysiol. 2016; 39 (8): 863–869. doi: 10.1111/pace.12883

23. Moreira R.I., Cunha P.S., Rio P., da Silva M.N., Branco L.M., Galrinho A., Feliciano J., Soares R., Ferreira R.C., Oliveira M.M. Response and outcomes of cardiac resynchronization therapy in patients with renal dysfunction. J. Interv. Card. Electrophysiol. 2018; 51 (3): 237–244. doi: 10.1007/s10840-018-0330-6.

24. Leyva F., Zegard A., Okafor O., de Bono J., McNulty D., Ahmed A., Marshall H., Ray D., Qiu T. Survival after cardiac resynchronization therapy: results from 50 084 implantations. Europace. 2019; 21 (5): 754–762. doi: 10.1093/europace/euy267

25. Zeljkovic I., Burri H.K., Breitenstein A., Ammann P., Mueller A., Auricchio A., Delacrétaz E., Dickstein K., Linde C., Normand C., Sticherling C. Cardiac resynchronisation therapy (CRT) Survey II: CRT implantation in Europe and in Switzerland. Swiss Medical Weekly. 2018; 148: w14643. doi: 10.4414/smw.2018.14643

26. Fomin I.V. Chronic heart failure in Russian Federation: what do we know and what to do. Rossiyskiy kardiologicheskiy zhurnal = Russian Journal of Cardiology. 2016; 136 (8): 7–13. [In Russian]. doi: 10.15829/15604071-2016-8-7-13

27. Kuznetsov V.A., Pokushalov E.A., Chudinov G.V., Zenin S.A., Krasnoperov P.V., Popov S.V., Lebedeva V.K., Bokeriya O.L., Pervova E.V., Ostern E.A., Kolunin G.V., Belonogov D.V. Clinical and demographic characteristics of patients with chronic heart failure with implanted devices for cardiac resynchronization therapy: data from the PANORAMA registry in Russia. Serdechnaya nedostatochnost’ = Russian Heart Failure Journal. 2011; 12 (3): 149–153. [In Russian].

28. Soldatova A.M., Kuznetsov V.A., Gizatulina T.P., Malishevsky L.M., Dyachkov S.M. The relationship of the prolonged PR interval with the long-term survival in patients with heart failure undergoing cardiac resynchronization therapy. Rossiyskiy kardiologicheskiy zhurnal = Russian Journal of Cardiology. 2020; 25 (1): 3348. [In Russian]. doi: 10.15829/1560-4071-2020-13348

29. Soldatova A.M., Kuznetsov V.A., Krinochkin D.V., Enina T.N. Super – response to cardiac resynchronization therapy. Eur. J. Heart Fail. 2017; 19 (Suppl. S1): 106. doi: 10.1002/ejhf.833

30. Kuznetsov V.A., Vinogradova T.O., Enina T.N., Kolunin G.V., Kharats V.E., Krinochkin D.V., Gorbatenko E.A. Influence of atrioventricular junction ablation on survival of patients with congestive heart failure and atrial fibrillation receiving cardiac resynchronisation therapy in real clinical practice. Global Heart. 2014; 9 (1S): e42.

31. Soldatova A.M., Kuznetsov V.A., Bogdanova D.S., Benzineb F.T. The incidence of frailty and its relationship with long-term survival in patients with heart failure and implanted cardiac resynchronization therapy devices. Rossiyskiy kardiologicheskiy zhurnal = Russian Journal of Cardiology. 2020; 25 (8): 3685. [In Russian]. doi: 10.15829/1560-4071-2020-3685