Predictors of clinical outcomes after cardiac resynchronization therapy in patients ≥75 years

doi:10.21203/rs.2.11022/v1

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Predictors of clinical outcomes after cardiac resynchronization therapy in patients ≥75 years

https://doi.org/10.21203/rs.2.11022/v1

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published 21 Nov, 2019

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Background: Cardiac resynchronization therapy benefit has been proved in selected patients with heart failure and reduced ejection fraction. Older patients have been underrepresented in CRT trials. This study was conducted to determine whether predictive factors of cardiac resynchronization therapy outcomes may differ in patients older and younger than 75 years. Methods: Consecutive patients who received cardiac resynchronization therapy device between 2013 and 2016 in our center were retrospectively included. The primary endpoint was cardiac resynchronization therapy effectiveness defined as combination of survival for one year with no heart failure hospitalization and improvement by one or more NYHA classes. Secondary endpoints were mortality, complications, and device therapies. Results: Among the 243 patients included, 102 were ≥75 years. Cardiac resynchronization therapy effectiveness was observed in 70 patients (50%) <75 years and in 48 patients (47%) ≥75 years (p=0.69). NYHA class ≥III (OR=6.02; CI95% [1.33-18.77], p=0.002) was a predictive factor of cardiac resynchronization therapy effectiveness only in ≥75 years group, while in <75 years group atrial fibrillation was independently negatively associated with primary endpoint (OR=0.28; CI95% [0.13-0.62], p=0.001). One-year mortality rate was 14% with no difference between age groups. Rescue cardiac resynchronization therapy and atrial fibrillation were independent predictive factors for mortality in both age groups. Eighty-two complications occurred in 45 patients (19%) with no difference between groups. Defibrillator use and QRS duration were independent predictive factors for complications in both age groups. There was no difference considering device therapies. Conclusion: At one-year, cardiac resynchronization therapy response is not compromised by patients age. In older patients, highly symptomatic individuals with NYHA class ≥III have better outcomes after cardiac resynchronization therapy. KEY WORDS: Resynchronization therapy; heart failure; aged; treatment outcome

Cardiac & Cardiovascular Systems

Health Economics & Outcomes Research

Geriatrics & Gerontology

Resynchronization therapy

heart failure

aged

treatment outcome

Cardiac resynchronization therapy (CRT) has become a standard therapy in patients with chronic heart failure (HF) related to reduced left ventricular ejection fraction (LVEF). Large clinical trials have demonstrated CRT benefits on symptoms, quality of life and morbi-mortality on top of optimal medical therapy. Current guidelines recommend CRT for selected patients regardless of age status¹ although older patients, defined as ≥65 years, and especially those ≥75 have been underrepresented in these studies². Prevalence of HF is increasing with age, and the European Survey on CRT reported that median age of patients was 70 with 31% patients ≥75 years³. A few reports already highlighted feasibility and efficiency of CRT in older patients but little is known about predictors of response in this population^4–8.

We aimed to determine age-related predictive factors of clinical outcomes in older patients receiving CRT.

Study population

We retrospectively included consecutive patients referred at Caen Normandy University Hospital for CRT device implantation between January 2013 and December 2016. CRT was implanted according to contemporary European guidelines⁹: New-York Heart Association (NYHA) functional class II to ambulatory IV, LVEF ≤ 35%, QRS duration ≥ 120ms and left-bundle branch block (LBBB) QRS morphology or QRS duration ≥ 150ms and non-LBBB QRS morphology, despite optimized medical treatment. After publication of latest guidelines in 2016¹, minimum QRS duration required was 130ms in case of LBBB QRS morphology. Patients with ventricular pacing indication and reduced LVEF as well as those with previous device upgraded to CRT pacemaker or CRT defibrillator were also included. We also considered patients implanted for rescue CRT, defined as CRT device implanted for amine-dependent end-stage HF. We excluded patients under 18 years or lost to follow-up. We defined older patients as those who were ≥75 years at the time of implantation and then divided our population into two age groups: <75 and ≥75 years.

Device therapy

CRT device was implanted using standard techniques. In case of atrial fibrillation (AF), atrioventricular node ablation was performed if medical treatment failed to achieve heart rate control. The choice between defibrillator and pacemaker for primary prevention of sudden cardiac death, as well as baseline programming were at the discretion of the attending physician.

Data collection

Evaluation of candidates for CRT implantation, except in case of rescue-CRT, had to be performed within 3-months before the procedure, including 12-lead electrocardiogram and standard two-dimensional echocardiography performed with IE 33™ or Epic 5™ system (Philips Healthcare, Amsterdam, Netherlands) in our center with LVEF measured using Simpson’s biplane method. Clinical, biological, electrocardiogram and echocardiographic data were anonymously collected.

Follow-up and clinical endpoints

Patients’ follow-up was scheduled according to our standard of care with physical examination and device interrogation, before hospital discharge, at one-month, six-month and one-year. Remote monitoring system was proposed if appropriate.

The primary endpoint was CRT effectiveness, defined as a modified combined clinical score previously described⁵: survival for one year with no heart failure hospitalization and improvement by ≥ one NYHA classes. Secondary endpoints were all-cause mortality, complications, and occurrence of device therapies in patients with a defibrillator. Appropriate device therapy was defined as anti-tachycardia pacing and/or internal shocks delivered to terminate sustained ventricular arrhythmia. Device therapy delivered in any other circumstance was considered inappropriate.

Statistical analysis

Categorical variables were expressed as numbers and percentages and compared using the Pearson Chi square or Fisher’s exact test depending on validity criteria. Continuous variables were expressed as mean and standard deviation if normally distributed or median and interquartile range. They were then compared using the student T-test or the Mann-Whitney Test. Association between baseline characteristics and the occurrence of clinical event was evaluated by univariate analysis. Variables with p value ≤0.20 in univariate analysis were then introduced in multivariate analysis using binary logistic regression model with Wald's step-by-step method. Survival time for primary endpoint was defined as the number of days between implantation and the first event. If a patient didn’t experience any endpoint during the follow-up period, his outcome was considered censored. The Kaplan- Meier method was used to construct survival curves, with the log-rank test used for comparison among groups. Statistical significance was set at a two-tailed probability level of <0.05. All analyses were performed using IBM SPSS Statistics for Windows version 20.0 (IBM Corp. Released 2011. Armonk, NY: IBM Corp.).

Baseline characteristics

Two hundred and fifty patients underwent CRT implantation; among them, 7 were excluded because of missing follow-up data. Hence, our study population comprised the remaining 243 patients, of which 102 (42%) were ≥75 years. Baseline characteristics according to age groups are summarized in Table 1. Patients were predominantly men but there were more women in ≥75 years group (23%) than in <75 years group (13%) (p=0.04). Patients ≥75 years were more symptomatic according to NYHA class, had more chronic kidney disease (CKD, defined by estimated glomerular filtration <60ml/min/1.73m²), and loop diuretics but less aldosterone antagonists. However, patients ≥75 years were less likely to have defibrillator than those <75 years (52% versus 87% respectively; p<0.001). Both groups had comparable LVEF impairment with a median LVEF of 28% (23.5-30), and mostly a LBBB QRS morphology (79%). There was no difference regarding proportion of upgraded device, CRT for rescue therapy and time procedure.

Table 1: Baseline characteristics and outcomes

Primary endpoint

There was no difference in CRT effectiveness between age groups with 70 patients considered responders out of 141 (50%) in <75 years group compared to 48 patients out of 102 (47%) in ≥75 years group (p=0.69). Outcomes are detailed in Table 1. In univariate and multivariate analyzes, NYHA class ≥III before implantation was associated with CRT response in overall population (OR=3.30; 95% confidence interval (CI95%) [1.70-6.51], p<0.001). NYHA class ≥III was strongly predictive of CRT effectiveness among older patients (OR=6.02; CI95% [1.33-18.77], p=0.002). In <75 years group, there was a trend towards better CRT response in patients with previous NYHA class ≥III (p=0.07). In univariate analysis, AF, CKD and rescue CRT were negatively associated with CRT response. Only AF and CKD remained predictors of CRT non-response in multivariate analysis in overall population. Moreover, AF negative impact was significant only in <75 years group (OR=0.28; CI95% [0.13-0.62], p=0.001) but not in ≥75 years group. Defibrillator use was not associated with primary endpoint. Results of univariate and multivariate analyzes in ≥75 years group are listed in Table 2 and those in <75 years group in Table 3.

Table 2: Univariate and multivariate analyzes of outcomes in the ≥75 years group

Table 3: Univariate and multivariate analyzes of outcomes in <75 years group.

Secondary endpoints

All-cause mortality

At one-year, mortality rates were 12% and 17% in <75 and ≥75 years groups respectively (p=0.31). Survival curves are represented in Figure 1. Defibrillator use was associated with better survival in univariate analysis (p=0.01) but not after logistic regression. Multivariate analysis showed that rescue CRT (p=0.01 and 0.002 in ≥75 and <75 years group respectively) and AF (p=0.04 and 0.02 in ≥75 and <75 years groups respectively) were associated with mortality in both groups. CKD was predictive of one-year mortality only in <75 years group (p=0.04) whereas ivabradine use was associated with mortality only in ≥75 years group (p=0.04).

Complications

Eighty-two complications were reported in 45 patients (19%) of the study population. There was no difference in the one-year complications rates between age groups, 15% and 21% in ≥75 and <75 years groups respectively (p=0.19). Lead dislodgment and re-interventions were the most frequent issues with a trend towards a greater rate of reinterventions in <75 years group (p=0.07). Only defibrillator use (p=0.003) and QRS duration (p=0.02) were found independent predictive factors in overall population. There was no age-related predictor of complications.

Device therapies in patients with defibrillator (n=175)

Nine (17%) patients ≥75 years experienced appropriate therapies compared to 11 (9%) patients <75 years (p=0.2). Only four patients, all in <75 years group, received inappropriate therapies.

In our study, older patients with CRT presented more comorbidities than younger counterparts. Such differences were highlighted in others studies⁴ and registries^3,10. However, they were likely to respond to CRT as well as younger individuals, considering a clinical combined endpoint for CRT effectiveness defined as survival for one year with no heart failure hospitalization and improvement by ≥ one NYHA classes. Patients ≥75 years old with previous NYHA ≥III class were found to better respond than less symptomatic individuals whereas functional status was not predictive of CRT response in younger individuals. CRT was also found to be safe in both age groups with no difference neither in mortality nor in complications rates. Strongest predictors of mortality, rescue CRT and AF, were not age-related.

Whether CRT could be as efficient in older patients as in younger remains uncertain. Observational studies^4,5,11,12 already showed that older patients are likely to respond to CRT as well as younger patients. In our study, age was not predictive of CRT response, as in a sub-analysis of two randomized trials comparing three age groups (<65; 65-75; >75 years) and reporting same improvements in LVEF and NYHA class regardless of age¹³. On the contrary, Maass et al. recently identified age <60 years as a predictive factor of reverse ventricular remodeling after CRT¹⁴. Little is known about response predictors according to age. We reported here for the first time that NYHA class ≥III at the time of implantation was associated with CRT response in the ≥75 years individuals but not in younger patients. Conversely, a recent study showed that NYHA class ≤III was an independent predictor of CRT benefit in a mid-sixties population¹⁵. On the contrary, AF has been associated with poor results of CRT¹⁶. In our study, this negative impact of AF was found in younger group whereas patients ≥75 years with AF improved as well as those in sinus rhythm.

There are conflicting results about CRT impact on mortality among older patients. We found no difference in mortality rates between age groups. This was also reported in limited studies⁵. Killu et al. showed after multivariate analysis no significant difference in survival between ≤80 and >80 years patients⁶. On the contrary, several authors pointed higher mortality rates among older patients^7,10,12,17 but with more non-cardiac death in these latter¹⁷ and similar time to death between age groups⁷. Diabetes mellitus, CKD and low functional capacity were predictive of worse survival in ≥75 years patients during long-term follow-up¹⁷. In our study we found that one-year mortality was strongly associated with rescue CRT and AF, which were not age-related. CKD was not associated with mortality in ≥75 age group but only in younger patients. The COMPANION trial reported that CRT reduced all-causes mortality only in defibrillator group¹⁸, whereas defibrillator use was not associated with survival neither in <75 nor in ≥75 years patients in our study. We also found that ivabradine use was predictive of death in older patients. We have no explanation for this finding that hasn’t been reported before and could be hazard-related. On the contrary, a recent study showed that ivabradine was well-tolerated in patients ≥70 years with systolic HF¹⁹.

There was no difference concerning complications after CRT implantation between age groups. Despite higher rates of comorbidities and advanced HF, age ≥75 years wasn’t associated with higher complications rates. This is consistent with most of published data^5,10. Höke et al reported only a trend towards higher incidence of pneumothorax and pocket hematoma in ≥75 years patients¹⁷. Nevertheless, risk of adverse events is the most frequent reported explanation for CRT age-limit observed in European centers²⁰. As reported recently²¹, we found that CRT defibrillator was more associated with complications than CRT pacemaker regardless of age.

Thus, our results support that CRT is essential for older adults. Those patients are difficult to “optimize” because of CKD and hypotension limiting medical therapy, disabilities limiting cardiac rehabilitation and others age-related features defining elderly’s frailty. Patients over 75 years, with advanced HF and high NYHA class, even with AF, should be considered for CRT. Age should not be a limit itself but individual risk has to be evaluated thanks to other comorbidities to decide CRT implantation whether associated or not with defibrillator.

Limits

Some limits of our study should be addressed. This retrospective study with a small sample size may be underpowered and subject to selection bias. Except in case of rescue CRT, we can assume that the frailest elderly patients were not implanted and this could lead to overestimate CRT benefit among the ≥75 years. Causes of death weren’t adjudicated and therefore not analyzed. Last, we didn’t retrieve cognitive status, quality of life score and end-of-life experiences whereas these outcomes are at great concerns especially for the older patients². Further studies should be designed to address these differences in outcomes predictors between younger and older patients with CRT.

CONCLUSION

Our study showed that very symptomatic older adults are likely to respond to CRT and that AF was not associated with worse outcomes. We also highlighted safety and efficiency of CRT regardless of patients’ age.

AF: Atrial fibrillation

CKD: Chronic kidney disease

CRT: Cardiac resynchronization therapy

HF: Heart failure

LBBB: Left-bundle branch block

LVEF: Left ventricular ejection fraction

NYHA: New-York Heart Association

Ethics approval and consent to participate

This retrospective study based on previous collected data complied with standards of Méthodologie de référence (MR-004) defined by Commission Nationale Informatique et Libertés and published in Journal Officiel de la République Française (JORF n°0160 du 13 juillet 2018 : Délibération n° 2018-155 du 3 mai 2018 portant homologation de la méthodologie de référence relative aux traitements de données à caractère personnel mis en œuvre dans le cadre des recherches n'impliquant pas la personne humaine, des études et évaluations dans le domaine de la santé (MR-004). Patient’s consent is not required for this study type.

Consent for publication

Not applicable

Availability of data and materials

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Competing interests

Authors have no conflict of interest regarding this study.

Funding

This study received no funding.

Authors’ contributions

LCR, ALC, PO, MC, AP, DL, PM conceived and designed the research. LCR, ALC, PO, MC, AP, DL collected and analyzed data. PO, LCR, ALC performed statistical analysis. LCR, ALC, PM wrote manuscript. All authors made critical revision of the manuscript and approved the final version. LCR and ALC contributed equally.

Acknowledgements

Not applicable

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Table 1: Baseline characteristics and outcomes.

	<75 years (n=141)	≥75 years (n=102)	p value
Age (years)	64 (10)	79 (7)	<0.001
Male gender, n (%)	122 (87)	78 (77)	0.04
Ischemic cardiomyopathy, n (%)	71 (50)	63 (62)	0.08
Atrial fibrillation, n (%)	66 (47)	56 (57)	0.14
Diabetes mellitus, n (%)	44 (31)	29 (29)	0.71
CKD, n (%)	62 (49)	68 (72)	0.001
NYHA functional class, n (%)
I	3 (2)	1 (1)	0.01
II	57 (40)	22 (21)
III	52 (37)	62 (61)
IV ambulatory	7 (5)	7 (7)
IV in hospital	22 (16)	10 (10)
Rescue CRT, n (%)	14 (10)	8 (8)	0.58
Beta blocker, n (%)	119 (85)	78 (79)	0.21
ACEI or ARB, n (%)	112 (80)	71 (72)	0.14
Aldosterone antagonist, n (%)	71 (51)	36 (36)	0.03
Loop diuretic, n (%)	105 (75)	85 (86)	0.04
Ivabradine, n (%)	21 (15)	11 (11)	0.38
Anticoagulation therapy, n (%)	73 (52)	59 (58)	0.33
Anti-platelet agent, n (%)	73 (52)	55 (54)	0.60
QRS morphology, n (%)
LBBB	110 (78)	82 (80)	0.50
RBBB	10 (7)	6 (6)
NIVCD	3 (2)	0
Paced QRS	18 (13)	14 (14)
LVEF (%)	28 (6)	28 (7)	0.47
CRT-D, n (%)	122 (87)	53 (52)	< 0,001
Upgrade, n (%)	41 (29)	25 (25)	0.43
Effectiveness, n (%)	70 (50)	48 (47)	0.69
One-year survival	124 (88)	85 (83)	0.31
NYHA improvement	86 (61)	67 (66)	0.72
No admission for HF	107 (76)	71 (70)	0.33
Complications, n in n patients (%)	55 in 30 (21)	27 in 15 (15)	0.19
Reintervention, n (% of complications)	24 (44)	9 (33)	0.07
Lead displacement, n (% of complications)	19 (34)	7 (26)	0.10
Implantation failure, n (% of complications)	3 (5)	5 (19)	0.23
Infection, n (% of complications)	6 (11)	3 (11)	0.59
Pneumothorax, n (% of complications)	2 (4)	2 (7)	0.74
Perforating lead, n (% of complications)	0	1 (4)	0.24
Pericardial effusion, n (% of complications)	1 (2)	0	0.39
Hematoma, n (% of complications)	0	0

Continuous variables are reported as median and interquartile range; categorical variables as numbers and percentages. ACEI: angiotensin-converting enzyme inhibitor; ARB: angiotensin II receptor blocker; CKD: chronic kidney disease (defined by estimated glomerular filtration <60ml/mn/1.73m²); CRT: cardiac resynchronization therapy; CRT-D: CRT with defibrillator; HF: Heart failure; LBBB: left bundle branch block; LVEF: left ventricular ejection fraction; NYHA: New-York Heart Association; NIVCD: non-specific intraventricular conduction delay; RBBB: right bundle branch block.

Table 2: Univariate and multivariate analyzes of outcomes in the ≥75 years group

	Univariate analysis		Multivariate analysis (model 1 with atrial fibrillation)		Multivariate analysis (model 2 with anticoagulation)
Primary endpoint	OR (95% CI)	p value	OR (95% CI)	p value	OR (95% CI)	p value
NYHA ≥III	5.91 (2.02-17.30)	0.001	6.02 (1.33-18.77)	0.002	6.30 (2.04-19.67)	0.001
Rescue CRT	0.49 (0.40-0.60)	0.01
CKD	0.41 (0.16-1.03)	0.06
Loop diuretics	0.32 (0.09-1.11)	0.06
Anticoagulation	0.51 (0.23-1.15)	0.10
Atrial fibrillation	0.51 (0.23-1.15)	0.10
ACEI-ARB	2.07 (0.84-5.11)	0.11	2.55 (0.91-7.11))	0.07	2.38 (0.87-6.49)	0.09
Surgery duration	1.87 (0.85-4.11)	0.12
QRS= 130-150ms	0.50 (0.20-1.27)	0.14
One-year mortality	OR (95% CI)	p value	OR (95% CI)	p value	OR (95% CI)	p value
Rescue CRT	58.8 (6.55-528-28)	<0.001	44.67 (2.91-686)	0.01	63.28 (4.47-896)	0.002
CRT-D	0.23 (0.07-0.75)	0.01
Atrial fibrillation	4.03 (1.07-15.20)	0.03	6.72 (0.99-45.61)	0.04
QRS>150ms	2.64 (0.86-8.15)	0.08	3.79 (0.79-18.21)	0.10
Surgery duration	0.39 (0.13-1.2)	0.09	0.11 (0.02-0.63)	0.01	0.14 (0.03-0.76)	0.02
CKD	3.54 (0.75-16.67)	0.09
Upgrade	0.36 (0.08-1.69)	0.10
Anticoagulation	2.43 (0.72-8.13)	0.14
Beta-blockers	0.42 (0.12-1.42)	0.15
Ivabradine	2.63 (0.60-11.41)	0.18	9.99 (1.17-85.42)	0.04	6.36 (1.10-36.90)	0.04
ACEI-ARB	0.47 (0.15-1.49)	0.19

Anticoagulation and atrial fibrillation were significantly correlated in ≥75 years group (Pearson coefficient 0.79, p<0.001). We performed two different regression models if p values were both <0.2 in univariate analysis. We reported here variables with p value ≤0.2 in univariate analysis and ≤0.10 in multivariate analysis. ACEI: angiotensin-converting enzyme inhibitor; ARB: angiotensin II receptor blocker; CKD: chronic kidney disease (defined by estimated glomerular filtration <60ml/mn/1.73m²); CRT: cardiac resynchronization therapy; CRT-D: CRT with defibrillator; NYHA: New-York Heart Association.

Table 3: Univariate and multivariate analyzes of outcomes in <75 years group.

	Univariate analysis		Multivariate analysis
Primary endpoint	OR (95% CI)	p value	OR (95% CI)		p value
Atrial fibrillation	0.36 (0.18-0.71)	0.003	0.28 (0.13-0.62)		0.001
CRT-D	2.39 (0.85-6.70)	0.09
Male gender	2.39 (0.85-6.70)	0.09
CKD	0.53 (0.26-1.07)	0.08
Ivabradine	2.25 (0.85-5.97)	0.10
NYHA ≥III	1.74 (0.89-3.41)	0.11	2.09 (0.95-4.59)		0.07
QRS<130ms	0.51 (0.21-1.24)	0.13
QRS>150ms	1.63 (0.83-3.17)	0.15
	Univariate analysis		Multivariate analysis (model 1 with atrial fibrillation)		Multivariate analysis (model 2 with anticoagulation)
One-year mortality	OR (95% CI)	p value	OR (95% CI)	p value	OR (95% CI)	p value
Atrial fibrillation	23.68 (3.04-184.30)	<0.001	14.35 (1.6-125.90)	0.02
Rescue CRT	17.48 (4.97-61.44)	<0.001	14.32 (2.61-79.20)	0.002	15.81 (3.35-75.10)	<0.001
CRT-D	0.11 (0.04-0.34)	<0.001
Beta-blockers	0.16 (0.05-0.51)	0.001
CKD	5.93 (1.61-21.83)	0.003	5.96 (1.13-31.30)	0.04	7.65 (1.47-39.61)	0.02
Anticoagulation	7.71 (1.68-33.26)	0.003			5.32 (0.96-29.40)	0.06
ACEI-ARB	0.26 (0.09-0.78)	0.01
Diabetes mellitus	2.86 (1.02-8.01)	0.04
Loop diuretics	5.67 (0.72-44.56)	0.07
NYHA ≥III	4.24 (1.16-15-48)	0.02
QRS>150ms	0.46 (0.15-1.38)	0.16
Complications	2.06 (0.69-6.08)	0.19	4.20 (0.91-18.91)	0.07

Anticoagulation and atrial fibrillation were significantly correlated in <75 years group (Pearson coefficient 0.69, p<0.001). We performed two different regression models if p values were both <0.2 in univariate analysis. We reported here variables with p value ≤0.2 in univariate analysis and ≤0.10 in multivariate analysis. ACEI: angiotensin-converting enzyme inhibitor; ARB: angiotensin II receptor blocker; CKD: chronic kidney disease (defined by estimated glomerular filtration <60ml/mn/1.73m²); CRT: cardiac resynchronization therapy; CRT-D: CRT with defibrillator; NYHA: New-York Heart Association.

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published 21 Nov, 2019

Read the published version in BMC Geriatrics →

Editorial decision: Major revision
03 Oct, 2019
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Review #1 received at journal
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Reviewer #1 agreed at journal
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Predictors of clinical outcomes after cardiac resynchronization therapy in patients ≥75 years

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Abstract

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BACKGROUND

METHODS

Study population

Device therapy

Data collection

Follow-up and clinical endpoints

Statistical analysis

RESULTS

Baseline characteristics

Primary endpoint

Secondary endpoints

DISCUSSION

Limits

CONCLUSION

LIST OF ABBREVIATIONS

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Ethics approval and consent to participate

Consent for publication

Availability of data and materials

Competing interests

Funding

Authors’ contributions

Acknowledgements

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