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2016. Volume 5. Issue 3. Article CID e0304 DOI: 10.15275/rusomj.2016.0304_
Cardiovascular surgery
Original article
Comparison of impact of medical therapy and surgical treatment on overall mortality in patients with
severe chronic heart failure: a meta-analysis
Olanna T. Kotsoeva
North-Caucasian Multidisciplinary Medical Center, Beslan, Russia
Received 16 May 2016, Accepted 17 June 2016
© 2016, Kotsoeva O.T. © 2016, Russian Open Medical Journal
Abstract: Aim — Meta-analysis of clinical trials comparing the efficacy of medical therapy (MT) and surgical treatment, including cardiac resynchronization therapy with and without cardioversion-defibrillation (CRT and CRT-D), circulatory support system (CSS) and heart transplantation (HT), in terms of decreasing overall mortality in patients with severe chronic heart failure (CHF).
Material and Methods — Meta-analysis included 39 clinical trials with a total number of 30,257 patients. Search was performed in MEDLINE, Medscape, Pubmed databases and on web resources, dedicated to clinical trials (National Institutes of Health, Clinical Center, ClinicalStudyResults.org, ClinicalTrials.gov).
Results — There was no significant overall mortality reduction in patients receiving MT when compared to control group: OR=0.97 (95% CI: 0.85-1.10), p=0.211. Treatment with CRT and CRT-D, as well as CSS implantation and HT reduced overall mortality: OR=0.67 (95% CI: 0.570.79), p < 0.001 for CRT/CRT-D and OR=0.46 (95% CI: 0.24-0.86), p = 0.018 for CSS/HT.
Conclusion — Superiority of surgical treatment over traditional MT in terms of overall mortality was observed in patients with severe CHF.
Keywords: chronic heart failure, medical therapy, cardiac resynchronization therapy, circulatory support system, heart transplantation
Cite as Kotsoeva OT. Comparison of impact of medical therapy and surgical treatment on overall mortality in patients with severe chronic heart failure: a meta-analysis. Russian Open Medical Journal 2016; 5: e0304.
Correspondence to Olanna T. Kotsoeva. Address: Department of Medical Rehabilitation, North-Caucasian Multidisciplinary Medical Center, 139a, Frieva str., 363025, Beslan, Russia. E-mail: olana-kocoeva@mail.ru
Introduction
In the last decades problem of choosing how to manage patients with chronic heart failure (CHF) is becoming more and more relevant, because new approaches to this condition are being developed and included in clinical guidelines [1-5]. Standard models of organizing care for patients with CHF are also being developed [6], methods of evaluating its quality and efficacy are being perfected [7] and CHF registries are created [8-14]. Researchers turn their attention to different aspects of CHF: from influence of low-intensity electromagnetic fields on endothelium function [15] and genetic determinants of CHF [16] to vegetative [17] and cognitive dysfunction [18].
Defining optimal treatment for patients with severe CHF to improve their short-term and long-term prognosis remains an unsolved problem for modern cardiology and cardiac surgery, as condition of many patients worsens even while receiving medical therapy (MT). This fact has stimulated the development of surgical techniques for management of severe CHF, such as cardiac resynchronization therapy (CRT), cardiac resynchronization therapy combined with cardioversion-defibrillation (CRT-D), circulatory support system implantation (CSS) and heart transplantation (HT), which have their efficacy already proven [1924].
Earlier we have conducted a five year prospective clinical trial to evaluate long-term results of medical and surgical treatment in 90 patients with New York Heart Association (NYHA) functional class III-IV of CHF, who have received treatment in A.N. Bakoulev Scientific Center for Cardiovascular Surgery in 2007 [25]. Advantage of surgical treatment over traditional MT in setting of severe CHF was shown.
Despite great interest towards surgical and medical management of severe CHF, we found no comparative metaanalyses on this topic in available literature.
Aim of this study was to perform a meta-analysis of major clinical trials which compared the efficacy of MT and surgical treatment (CRT, CRT-D, CSS and HT) of patients with severe CHF.
Material and Methods
The meta-analysis included 39 clinical trials [25-67] with a total number of 30257 patients. Search was performed in MEDLINE, Medscape, Pubmed databases and on web resources, dedicated to clinical trials (National Institutes of Health, Clinical Center, ClinicalStudyResults.org, ClinicalTrials.gov).
2016. Volume 5. Issue 3. Article CID e0304 DOI: 10.15275/rusomj.2016.0304_
Cardiovascular surgery
Table 1. Brief description of studies which evaluated efficacy of MT in patients with severe CHF
Year Ref. Name of study Study group, n Control group, n Study design Drug class
2013 [66] ASTRONAUT study 808 807 aliskiren vs placebo DRIs
2001 [47] BEST study 1,354 1,354 bucindolol vs placebo ß-blockers
1987 [27] Bussmann study 12 11 Captopril vs placebo ACEIs
1999 [45] CIBIS II study 1,327 1,320 bisoprolol vs placebo ß-blockers
1994 [35] CIBIS study 320 321 bisoprolol vs placebo ß-blockers
1997 [42] Cohn study 70 35 carvedilol vs placebo ß-blockers
1987 [30] CONSENSUS study 127 126 enalapril vs placebo ACEIs
1994 [36] Cowley study 75 76 enoximone vs placebo PDEIs
1995 [40] Dickstein et al. study 108 58 losartan vs enalapril AngRBs
2007 [62] EMOTE study 101 100 enoximone vs placebo PDEIs
2003 [53] EPHESUS 3,319 3,313 eplerenone vs placebo AldRBs
2009 [64] ESSENTIAL II 472 478 enoximone vs placebo PDEIs
1994 [37] Fisher study 25 25 metoprolol vs placebo ß-blockers
1993 [34] Ghose study 50 51 hydralazine, isosorbide dinitrate vs placebo Vasodilators
1999 [46] Hamroff et al. study 16 17 losartan+ACEI vs ACEI AngRBs
1991 [31] IRG study 103 44 imazodan vs placebo PDEIs
1987 [28, 29] Kassis study 10 10 felodipine vs placebo CCBs
1995 [39] Krum study 33 16 carvedilol vs placebo ß-blockers
1991 [32] Lechat study 6 6 nebivolol vs placebo ß-blockers
1991 [40] Maass-a study 87 45 ramipril vs placebo ACEIs
1991 [41] Maass-c study 47 48 ramipril vs placebo ACEIs
1986 [26] Packer study 21 21 captopril vs enalapril ACEIs
2000 [56, 67] PRAISE II study 826 826 amlodipine vs placebo CCBs
1996 [41] PRAISE study 571 582 amlodipine vs placebo CCBs
1997 [43] PRIME II study 953 953 ibopamin vs placebo PDEIs
1991 [33] PROMISE study 561 527 milrinone vs placebo PDEIs
1998 [44] VEST study 2,550 1,283 vesnarinon vs placebo PDEIs
ACEIs, angiotensin-converting enzyme inhibitors; AldRBs, aldosterone receptor blockers; AngRBs, angiotensin receptor blockers; CCBs, calcium channel blockers; DRIs, direct renin inhibitors; PDEIs, phosphodiesterase-3 inhibitors.
Following keywords were used during the search: "heart failure", "ventricular dysfunction", "cardiac resynchronization therapy", "heart transplantation", "mechanical assist devices", "LVAD", "randomized controlled trial", "congestive heart failure", "biventricular pacing," "chronic cardiac failure resynchronization therapy," "Medtronic," "InSync," "Guidant," "St. Jude," "implantable defibrillators," "ICD," "single chamber ICD," "dual chamber ICD," "congestive heart failure," "CHF," "chronic heart failure," "biventricular assist device implantation", "continuous-flow LVAD", "ambulatory pts with HF", "quality of life", "exercise capacity", "peak oxygen consumption", "controlled clinical trial," "meta-analysis".
Inclusion criteria for the trials to be included in meta-analysis were:
• papers published in 1977-2014 (however, one trial was completed in 2014, but its results were published later, and it was included in meta-analysis [25]);
• randomized clinical trials (RCT), observational studies (prospective and retrospective, case-control studies), which included patients with NYHA class III-IV CHF and contained data on control / comparison groups;
• trials which compared one of single or combined treatments (MT, CRT, CRD-D) with lack of treatment or absence of one of treatment components (for combined treatment), and trials which compared efficacy and safety of CSS usage (based on pulse-style pumps) with MT, and trials which evaluated orthotopic HT;
• trials which included data on overall mortality.
Exclusion criteria for trials: conference reports, clinical cases,
case series, expert reports and opinions.
Primary endpoints: overall mortality.
Twenty seven trials were dedicated to analysis of MT efficacy
(Table 1). This group included 7 trials which evaluated the impact of using P-blockers [32, 35, 37, 39, 42, 45, 47], one trial which evaluated usage of aldosterone receptor blockers (AldRBs) [53], 5 trials which evaluated angiotensin-converting enzyme inhibitors (ACEIs) [26, 27, 30, 40], 2 trials on effects of angiotensin receptor blockers (AngRBs) [38, 46], 3 trials on effects of calcium channel blockers (CCBs) [28, 29, 41, 56, 67], 7 trials which evaluated effects of phosphodiesterase-3 inhibitors (PDEIs) [31, 33, 36, 43, 44, 62, 64], one trial on direct renin inhibitors (DRIs) [66] and one trial on vasodilator usage [34].
Thirteen trials described the effect of CRT in patients with severe CHF (Table 2). Seven trials evaluated efficacy of CRT only [48, 50-52, 57, 58, 60, 63, 65]. One trial [54] compared efficacy of cardiac resynchronization therapy combined with cardioversion-defibrillation (CRT-D) and efficacy of cardioversion-defibrillation only. Two trials compared efficacy of CRT-D with no resynchronization therapy [55, 61]. COMPANION (CRT vs MT) trial [55, 59] evaluated CRT with optimal MT. One trial (Kotsoeva-Bockeria) [24, 25] evaluated efficacy of CRT and CRT-D compared with MT in patients with severe CHF.
Also, meta-analysis included 2 trials on evaluation of efficacy and safety of surgical treatment for terminal CHF: REMATCH study [49] and Kotsoeva-Bockeria study (CSS, HT vs MT) [25, 68]. In these trials efficacy and safety of CSS usage, orthotopic HT and MT in patiens with NYHA class III-IV CHF were compared.
Meta-analysis was performed using Meta-analysis Comprehensive V.2.0 software (Biostat Inc., USA). In cases of insignificant statistical heterogeneity in trials (I2 <50%) the analysis was performed using fixed effects model. High statistical heterogeneity (I2 >50%) required us to use random effects model. Treatment effects were evaluated by calculating odds ratio (OR) and 95% confidence interval (95% CI).
2016. Volume 5. Issue 3. Article CID e0304 DOI: 10.15275/rusomj.2016.0304_
Cardiovascular surgery
Table 2. Brief description of studies which evaluated efficacy of CRT in patients with severe CHF
Year Ref. Name of study Study group, n Control group, n Study design
2005 [57, 63, 65] CARE-HF study 409 404 CRT vs non-CRT
2004 [55, 59] COMPANION (CRT vs MT) study 617 154 CRT vs MT
2004 [55] COMPANION (CRT+ICD vs CRT) study 595 617 CRT-D vs CRT
2004 [55, 59] COMPANION (CRT+ICD vs MT) study 595 154 CRT-D vs MT
2006 [60] HOBIPACE 16 16 CRT vs non-CRT
2002 [58] MIRACLE study 228 225 CRT vs non-CRT
2003 [54] MIRACLE-ICD-I study 187 182 CRT-D vs CVDF
2002 [51] MUSTIC AF study 25 18 CRT vs non-CRT
2001 [48] MUSTIC-SR study 29 29 CRT vs non-CRT
2002 [50] PATH-CHF study 24 17 CRT vs non-CRT
2003 [52] RD-CHF study 22 22 CRT vs non-CRT
2007 [61] RethinQ study 85 85 CRT-D vs non-CRT
2014 [25, 68] Kotsoeva-Bockeria (CRT, CRT-D vs MT) 30 30 CRT, CRT-D vs MT
CRT, cardiac resynchronization therapy; CRT-D, cardiac resynchronization therapy combined with cardioversion-defibrillation; CVDF, cardioversion-defibrillation; MT, medical therapy; non-CRT, patients without cardiac resynchronization therapy.
Table 3. Data on lethality in patients with severe CHF on different modes of treatment (results of randomized clinical studies)_
Treatment option Name of study Study group, n Control group, n
Total number of patients Event frequency Total number of patients Event frequency
MT BEST study 1,354 411 1,354 449
MT Bussmann study 12 2 11 3
MT Kassis study 10 5 10 3
MT CIBIS study 320 53 321 67
MT CIBIS II study 1,327 156 1,320 228
MT Colin study 70 2 35 2
MT CONSENSUS study 127 50 126 68
MT Cowley study 75 27 76 18
MT Dictntein et al. study 108 2 58 2
MT EMOTE study 101 38 100 31
MT EPHESUS 3,319 478 3,313 554
MT ESSENTIAL 472 157 478 144
MT Fisher study 25 1 25 2
MT Gime study 50 11 51 14
MT Hamroff et al. study 16 0 17 1
MT IRG study 103 8 44 3
MT Krum study 33 3 16 2
MT Mans-a study 87 8 45 4
MT Mans-c study 47 1 48 1
MT Pater study 21 1 21 1
MT PRAISE study 571 190 582 223
MT PRAISE II study 826 278 826 262
MT PRIME II study 953 232 953 193
MT PROMISE study 561 168 527 127
MT VEST study 2,550 560 1,283 242
CRT CARE-HF study 409 82 404 120
CRT COMPANION (CRT vs MT) study 617 131 154 39
CRT COMPANION (CRT-ICD vs CRT) study 595 105 617 131
CRT COMPANION (CRT-ICD vs MT) study 595 105 154 39
CRT HOBIPACE 16 1 16 1
CRT MIRACLE study 728 12 225 16
CRT MIRACLE-ICD-1 study 187 4 182 5
CRT MUSTIC AF study 25 1 18 0
CRT MUSTIC-SR study 29 1 29 0
CRT PATH-CHF study 24 2 17 0
CRT RD-CHF study 22 2 22 4
CRT RethinQ study 85 5 85 2
CRT Kotsoeva-Bockeria (CRT, CRT-D vs MT) 30 2 30 11
HT REMATCH study 66 41 68 54
HT Kotsoeva-Bockeria (CSS, HT vs MT) 30 7 30 11
CRT, cardiac resynchronization therapy; CSS, circulatory support system; HT, heart transplantation; MT, medical therapy.
2016. Volume 5. Issue 3. Article CID e0304 DOI: 10.15275/rusomj.2016.0304_
Cardiovascular surgery
CARFHF -IIK:.
COMRAMON (CRT vs MT) study COMPANION (CRT'[CD vs CRT Ï study COMPANION (ORT'ICD vi MT) study IЮШ РАСЕ MIRACLE slvdy
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MLJSTIC AF study MLJSTIC-KH ütiidy ;;д|.. .--)- ..:.„tv ttO'CNh S1UÜV Kotmnü StLKt^
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REMATCH study
Kotsoeva-BocKeria (CSS, HT va MT}
Total (fixed effects)
Figure 1. A metagraph of overall mortality in patients with severe CHF on MT (a), CRT / CRT-D (b) and CSS usage / after HT (c) compared to control group.
Left column shows names of the trials (brief description of trials is given in Tables 1, 2 and text). «Total» - total evaluation of odds ratios.
0.79), p<0.001 (Figure 1b) for CRT/CRT-D and OR=0.46 (95% CI: 0.24-0.86), p=0.018 (Figure 1c) for CSS/HT. No significant difference was onserved between CRT/CRT-D and CSS/HT in terms of overall mortality decrease.
Discussion
Results obtained in this meta-analysis complement existing knowledge on value of various options of surgical treatment for severe CHF. Evidence on a certain degree of superiority of surgical management over traditional MT in terms of decrease in overall mortality was gained.
CRT is studied most comprehensively of all surgical options. It is known that effect of CRT is pathogenetically based on its influence on interventricular dyssynchrony, which elevates personal risk level in patients with severe CHF [69]. Meta-analysis of CRT and CRT-D efficacy in patients with CHF is known, where it was demonstrated that CRT decreases overall mortality and hospitalization rate due to CHF, irrespective of NYHA class [70]. However, patients with I-II NYHA class CHF had too many adverse events, so is is advised to use CRT only for III-IV NYHA class patients [70]. It is important to note that CRT is seen by some authors as a temporary alternative solution for patients who will inevitably require transplantation [71, 72].
CSS implantation allows to improve quality of life of patients with severe CHF for a prolonged period, which is especially important for those who are in line for HT. M.S. Slaughter et al. [73] have demonstrated a relative safety of modern CSS in terms of stroke risk. A relatively favorable prognosis in patients with severe CHF with active CSS is confirmed by several literature reviews [74].
HT surgery is also a treatment of choice for selected patients with terminal CHF, especially when other options fail. Of course, HT is unable to radically change the situation with CHF on a population level [75].
It is out of the question that clinical decision making and personal risk evaluation for surgical management of severe CHF should be done with consideration of other risk factors, already well studied for cardiosurgical patients [76-80].
Of all trials included in this meta-analysis, none evaluated gender-specific effects of treating severe CHF on long-term prognosis. This problem requires thorough research in the future, with results by S. Zabarovskaja et al. taken into account [24], which provide evidence of lower long-term mortality in women who were treated with CRT when compared to men.
Study Limitations
An important limitation of this study was small number of trials on HT included for analysis.
a
b
c
Results
Meta-analysis of overall mortality in patients with severe CHF was performed by each treatment type (Table 3). There was no significant decrease of overall mortality risk in patients who received MT when compared to control group: OR=0.97 (95% CI: 0.85-1.10), p=0.211 (Figure 1a). Treatment of patients with severe CHF using CRT and CRT-D and also by CSS implantation and HT significantly decreased overall mortality: OR=0.67 (95% CI: 0.57-
Conclusion
Primarily, this meta-analysis has demonstrated the advantages of surgical options for treatment of severe CHF (such as CRT, CRT-D, CSS and HT) over traditional MT in terms of decrease of overall mortality.
Conflict of interest: none declared.
2016. Volume 5. Issue 3. Article CID e0304 DOI: 10.15275/rusomj.2016.0304_
Cardiovascular surgery
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Authors:
Olanna T. Kotsoeva - MD, PhD, Head of Department of Medical Rehabilitation, North-Caucasian Multidisciplinary Medical Center, Beslan, Russia.
