In ambulatory sufferers with full coronary heart block (CHB), dual-chamber (DDD) pacing confers physiological advantages versus single-chamber (VVI) pacing, nonetheless, the influence on mortality is disputed. Nonagenarians represent an increasing proportion of pacemaker recipients, but information on gadget choice and outcomes are restricted, particularly in emergency conditions.
In nonagenarians with emergent CHB, we in contrast the scientific traits and outcomes of sufferers receiving VVI versus DDD pacemakers. Cox proportional-hazards evaluation examined all-cause mortality and demise from congestive cardiac failure (CCF).
There have been 168 consecutive sufferers followed-up for 30.6 ± 15.5 months. Of those, 22 sufferers (13.1%) acquired VVI pacemakers; in comparison with DDD recipients, these sufferers had comparable median age (93 vs. 91 years, p=0.15) and left ventricular (LV) systolic perform (LV ejection fraction [EF] 49.2% ± 9.7 vs. 50.7% ± 10.1, p=0.71), however have been extra frail (Rockwood scale 5.2 ± 1.8 vs. 4.3 ± 1.1, p=0.004) and extra more likely to have dementia (27.3% vs. 8.9%, p=0.011). Put up-implant, gadget interrogation demonstrated that VVI recipients had larger respiratory charges (21.3 ± 2.4 vs. 17.5 ± 2.6 breaths per minute, p=0.002), decrease imply coronary heart charges (65.5 ± 10.1 vs. 71.9 ± 8.6 bpm, p=0.002), and decrease each day exercise ranges (0.57 ± 0.3 vs. 1.5 ± 1.1 hours of exercise, p=0.016) than DDD recipients. Adjusting for age, frailty and dementia, VVI pacing was related to an elevated threat of all-cause mortality (adjusted hazard ratio [HR] 2.1, 95% confidence interval [CI] 1.08 to 4.1, p=0.03) and demise from CCF (adjusted HR 7.1, 95percentCI 2.5 to twenty.6, p<0.001).
In conclusion, in nonagenarians with emergent CHB, dual-chamber pacing was related to improved symptomatic and prognostic outcomes versus single-chamber pacing.
Introduction
In ambulatory people with high-grade atrioventricular (AV) block, it’s well-established that restoration of AV synchrony with dual-chamber pacing confers necessary physiological advantages over single-chamber pacing, together with enhancements in train capability, discount in incident atrial fibrillation (AF), and avoidance of pacemaker (PPM) syndrome.1,2 The influence of dual-chamber pacing on mortality stays disputed and, in older individuals, it has been proposed that the anticipated benefits of physiological pacing methods could also be mitigated by the upper prevalence of comorbidities and non-arrhythmic demise.1,3 Accordingly, the PASE (Pacemaker Choice within the Aged, 1998), UKPACE (United Kingdom Pacing and Cardiovascular Occasions, 2005), and CTOPP (Canadian Trial of Physiological Pacing, 2004) randomised-controlled trials didn’t report survival variations between single- or dual-chamber pacing methods in sufferers over the age of 65, 70, or 75 years of age, respectively.4–6
Regardless of this, extra not too long ago, Krzemień-Wolska et al. (2018) and Pérez-Díaz et al. (2019) reported an affiliation between dual-chamber pacing and improved survival in sufferers over 80 years of age with a combination of symptomatic AV block and sinus node illness.7,8 Likewise, Loirat et al. (2015) discovered that single-chamber pacing in sinus rhythm (i.e. non-physiological pacing) was independently related to all-cause mortality in nonagenarians.7,9 Whereas these modern observational research seem to assist dual-chamber gadgets in older sufferers, the choice so as to add complexity to a pacemaker process by implanting a second (i.e. atrial) lead is especially consequential on this inhabitants. In nonagenarians present process pacemaker implant, Dang et al. (2018) reported that procedural problems conferred a four-fold threat of mortality.10
Though nonagenarians comprise only one% of the UK inhabitants, at our establishment, since 2016, over 10% of sufferers who underwent cardiac implantable digital gadget (CIED) procedures have been aged over 90 years (determine 1).11 As such, we recommend that extra information are needed to assist information gadget choice on this increasing inhabitants, notably in emergency conditions the place scientific evaluate and doctor decision-making are time vital. We, due to this fact, investigated the presentation, demographics, symptomatic and prognostic outcomes for nonagenarians present process emergency pacemaker implant for full coronary heart block (CHB), inspecting the influence of single- (VVI) versus dual-chamber (DDD) pacing.
![Maclean - Figure 1. Participant recruitment flow chart](https://bjcardio.co.uk/wp-content/uploads/2024/06/Maclean-Figure-1.png)
Technique
Information have been extracted from a safe inner registry comprising 7,383 consecutive transvenous CIED procedures carried out at a single UK tertiary cardiac centre from 2016 to 2019. Scientific data have been screened to determine emergency transvenous pacemaker implants for sufferers with CHB over 90 years of age (determine 1). Sufferers with atrial arrhythmias or sinus arrest have been excluded.
Admission pathway
All included sufferers have been admitted to our centre in an emergency through the London Ambulance Service. Sufferers have been both identified with CHB in the neighborhood and conveyed on to our centre from their place of residence, or transferred following redirection from one among 11 regional emergency departments. On arrival, scientific evaluation and bedside assessments included 12-lead electrocardiogram (ECG), targeted echocardiogram, and venous blood gasoline sampling. Frailty was estimated in line with the Rockwood scientific frailty scale.12 Unstable sufferers underwent therapy with optimistic chronotropic medicine (atropine boluses or an isoprenaline infusion) and exterior transcutaneous pacing, as required. A guide electrophysiologist reviewed the scientific information to find out the urgency of pacemaker implantation. Scientific periods have been outlined as ‘in hours’ between 0800 and 1700 on Monday to Friday; all different periods have been outlined as ‘out of hours’.
Implant approach
All procedures have been carried out in a catheter laboratory underneath native anaesthetic and sedation, or underneath normal anaesthetic. All sufferers acquired a bolus of two intravenous antibiotics inside two hours of the process: gentamicin 5 mg/kg (most dose 450 mg) plus both flucloxacillin 1 g or, in sufferers with penicillin allergy or a optimistic or unknown methicillin-resistant Staphylococcus aureus (MRSA) standing, teicoplanin 6 mg/kg rounded to the closest 100 mg. Sufferers with each penicillin and teicoplanin allergy acquired both a cephalosporin or vancomycin, relying on the character of the allergic response. Chlorhexidine scrub was used previous to pores and skin draping. Native anaesthetic was administered within the type of 1% lignocaine. Following infraclavicular incision, a pre-pectoral pocket was usual, except precluded by lack of subcutaneous tissue, during which case a sub-pectoral pocket was used. Venous entry was obtained through direct cephalic cannulation, or by extrathoracic axillary puncture guided by fluoroscopy or ultrasound. Lively or passive leads have been deployed in line with operator desire. All lead collars have been secured with Ethibond, and wounds have been closed with layers of Polydioxanone (PDS), Vicryl, Monocryl, or a mix of those sutures. 3M Steri-Strips and a SoftporeTM adhesive dressing have been affixed to the pores and skin floor, and a stress dressing utilized in line with operator desire. No post-procedural oral antibiotics have been prescribed on this research. Sufferers have been suggested to maintain their wounds lined and dry for seven days; this was prolonged to 10 days in these with a historical past of diabetes. Within the absence of problems, ambulatory sufferers have been discharged 24 hours following their implant. These sufferers requiring additional rehabilitation have been transferred again to their native hospital for ongoing administration.
Comply with-up
Sufferers have been reviewed in a specialist CIED clinic at one, six and 12 months post-implant, and yearly thereafter, except an expedited evaluate was requested by the affected person or affected person’s doctor. Within the occasion of demise, explanation for demise was retrieved from the affected person’s normal practitioner.
Ethics
The research was registered with the native scientific effectiveness unit; as this was a retrospective evaluation of registry information for the needs of high quality assurance, the necessity for formal moral approval was waived by our establishment.
Statistical strategies
Statistical evaluation was carried out utilizing R. The Shapiro-Wilk take a look at discerned whether or not or not information have been usually distributed. Categorical group variables have been in contrast utilizing a Z-test for variations of proportion. Steady variables have been analysed utilizing two-tailed unpaired t-tests for usually distributed information or the Mann–Whitney U take a look at for non-normally distributed information. Group outcomes have been in contrast utilizing Fisher’s actual take a look at. Univariate Cox-proportional hazards evaluation for the prediction of all-cause mortality and demise from congestive cardiac failure (CCF) was carried out for sufferers’ baseline traits, threat components and procedural variables. The proportional hazards assumption was examined in line with the connection between scaled Schoenfeld residuals with time. Stepdown multi-variate evaluation (R bundle: My.stepwise) was carried out subsequently together with all uni-variate components with p<0.25; a variance inflating issue (VIF) was generated to evaluate for multi-collinearity with a cut-off of two.5 set for categorical variables and 10 for steady variables. Usually distributed information are introduced as imply ± commonplace deviation (SD) and non-normally distributed information as median (interquartile vary [IQR]). Hazard ratios (HR) are supplied with 95% confidence intervals (CI); the extent of significance for all assessments was set at p<0.05.
Outcomes
There have been 168 sufferers included and so they have been followed-up for 30.6 ± 15.5 months. Sufferers’ baseline traits, admission physiological information and outcomes – stratified by sort of gadget acquired – are proven in desk 1. There have been 62 sufferers (36.9%) admitted straight from their place of residence. There have been 106 sufferers (63.1%) admitted throughout an out-of-hours scientific session, and 90 sufferers (53.6%) underwent PPM implant throughout the identical scientific session during which they arrived. There have been 26 sufferers (15.6%) who required an isoprenaline infusion, eight (4.8%) necessitated a interval of transcutaneous pacing, and 12 (7.1%) underwent short-term wire insertion initially of the implant process. There have been 4 problems; one pneumothorax in a affected person receiving a single-chamber pacemaker, one cardiac perforation requiring pericardiocentesis in a affected person receiving a dual-chamber pacemaker, and two atrial lead displacements in sufferers receiving dual-chamber pacemakers, which required revision procedures. 4 sufferers died previous to hospital discharge; two of cardiogenic shock and two of community-acquired bronchopneumonia.
Desk 1. Demographics, admission and procedural information, and outcomes for nonagenarians present process emergency single- versus dual-chamber pacemaker implant
Parameter
Single chamberN=22
Twin chamberN=146
p worth
Demographics
Median age (IQR), years
93 (91–94)
91 (91–93)
0.15
Male, n (%)
9 (40.1)
66 (45.2)
0.7
Comorbidities, n (%)
Diabetes mellitus
4 (18.2)
31 (21.2)
0.74
Hypertension
11 (50)
96 (65.8)
0.15
Ischaemic coronary heart illness (MI, PCI or CABG)
4 (18.2)
29 (19.9)
0.85
Historical past of cardiac surgical procedure
0 (0)
7 (4.8)
0.29
Lively malignancy
2 (9.1)
18 (12.3)
0.66
Dementia
6 (27.3)
13 (8.9)
0.011
Useful standing
Imply Rockwood scale rating ± SD
5.2 ± 1.8
4.3 ± 1.1
0.004
Receiving each day help from group carer(s) at residence, n (%)
8 (36.4)
31 (21.2)
0.12
Residential residence resident, n (%)
6 (27.3)
15 (10.3)
0.024
Nursing residence resident, n (%)
3 (13.6)
9 (6.2)
0.2
Physiological parameters
Median coronary heart charge (IQR), bpm
34.5 (31.5–42)
38 (32–50)
0.45
Imply systolic blood stress on arrival ± SD, mmHg
137.9 ± 48
152.1 ± 36
0.12
Imply pH ± SD
7.34 ± 0.06
7.36 ± 0.06
0.43
Median venous lactate (IQR), mmol/L
2 (1.75–2.925)
1.85 (1.275–2.325)
0.48
Median eGFR (IQR), ml/min/1.73 m2
49 (48–66)
51.5 (34–64)
0.42
Imply LVEF ± SD, %
49.2 ± 9.7
50.7 ± 10.1
0.71
Admission information
Admitted out of hours, n (%)
10 (45.4)
68 (46.6)
0.92
Underwent process throughout the identical scientific session during which they arrived, n (%)
14 (63.7)
76 (52.1)
0.31
Imply period of signs ± SD, days
1.95 ± 2.4
3.9 ± 7.4
0.23
Syncope, n (%)
2 (9.1)
34 (23.3)
0.13
Pacing parameters
Imply base charge ± SD, bpm
59.5 ± 11.7
57.7 ± 5.3
0.22
Imply atrial pacing ± SD, %
NA
22 ± 23.4
NA
Imply ventricular pacing ± SD, %
91.3 ± 12.7
80.1 ± 33.3
0.13
Charge response on, n (%)
20 (90.1)
18 (12.3)
<0.001
Outcomes, n (%)
Loss of life inside 90 days
7 (31.8)
9 (6.2)
<0.001
Loss of life (long run)
13 (59.1)
52 (35.6)
0.034
Loss of life from CCF (long run)
9 (40.9)
9 (6.2)
<0.001
Problems
1 (4.5)
3 (2.1)
0.48
Key: CABG = coronary artery bypass graft; CCF = congestive cardiac failure; eGFR = estimated glomerular filtration charge; IQR = interquartile vary; LVEF = left ventricular ejection fraction; MI = myocardial infarction; NA = not relevant; PCI = percutaneous coronary intervention; SD = commonplace deviation
Sufferers who acquired VVI pacemakers have been extra frail (Rockwood scale 5.2 ± 1.8 vs. 4.3 ± 1.1, p=0.004), extra more likely to have cognitive impairment (prevalence of dementia 27.3% vs. 8.9%, p=0.011), and extra more likely to stay in a residential residence (27.3% vs. 10.3%, p=0.024) than those that acquired DDD pacemakers.
Close to physiological information from gadget interrogations, VVI recipients had larger respiratory charges (21.3 ± 2.4 vs. 17.5 ± 2.6 breaths per minute, p=0.002), decrease imply coronary heart charges (65.5 ± 10.1 vs. 71.9 ± 8.6 bpm, p=0.002), and decrease each day exercise ranges (0.57 ± 0.3 vs. 1.5 ± 1.1 hours of exercise, p=0.016) than DDD recipients.
In step with their elevated frailty, demise at 90 days post-implant (31.8% vs. 6.2%, p<0.001) and long run (59.1% vs. 35.6%, p<0.001) was extra widespread within the VVI group. VVI sufferers have been additionally extra more likely to die from congestive cardiac failure than DDD recipients (40.9% vs. 6.2%, p<0.001) regardless of comparable baseline left ventricular (LV) ejection fraction. These findings have been corroborated by temporal survival estimates: all-cause mortality log-rank p=0.0002 (determine 2); demise from CCF log-rank p<0.0001 (determine 3).
![Maclean - Figure 2. Kaplan-Meier plot demonstrating probability of all-cause mortality for nonagenarians receiving emergency single- versus dual-chamber pacemakers](https://bjcardio.co.uk/wp-content/uploads/2024/06/Maclean-Figure-2.png)
![Maclean - Figure 3. Kaplan-Meier plot demonstrating probability of death from congestive cardiac failure for nonagenarians receiving emergency single- versus dual-chamber pacemakers](https://bjcardio.co.uk/wp-content/uploads/2024/06/Maclean-Figure-3.png)
Uni-variate and subsequent stepdown multi-variate evaluation is proven in desk 2. After adjusting for vital covariates, VVI pacemakers have been independently related to all-cause mortality (adjusted HR 2.1, 95percentCI 1.08 to 4.1, p=0.03) and demise from CCF (adjusted HR 7.1, 95percentCI 2.5 to twenty.6, p<0.001).
Desk 2. Uni-variate and stepdown multi-variate evaluation of things related to all-cause mortality and demise from congestive cardiac failure (CCF)
Parameter
Uni-variate HR (95percentCI)
p worth
Multi-variate HR (95percentCI)
p worth
Loss of life (all-cause mortality)
Age
1.09 (0.99 to 1.19)
0.06
1.09 (0.99 to 1.2)
0.084
Rockwood scale
1.35 (1.11 to 1.64)
0.002
1.18 (0.96 to 1.47)
0.11
Dementia
2.5 (1.3 to 4.9)
0.005
1.59 (0.75 to three.4)
0.22
Male
0.89 (0.54 to 1.4)
0.66
Out of hours admission
1.4 (0.85 to 2.3)
0.18
QRS period >130 ms
1.04 (0.96 to 1.75)
0.89
Extreme LV systolic dysfunction
1.9 (0.58 to six.2)
0.28
Historical past of IHD
1.2 (0.64 to 2.2)
0.6
Diabetes
1.36 (0.76 to 2.4)
0.3
VVI pacemaker implanted
2.64 (1.4 to 4.8)
0.002
2.1 (1.08 to 4.1)
0.03
Loss of life from congestive cardiac failure
Age
1.1 (0.96 to 1.3)
0.15
1.16 (0.96 to 1.4)
0.12
Rockwood scale
1.67 (1.2 to 2.3)
0.003
1.25 (0.89 to 1.7)
0.2
Dementia
2.27 (0.64 to eight)
0.2
0.8 (0.2 to three.4)
0.81
Male
0.98 (0.38 to 2.5)
0.96
Out of hours admission
0.97 (0.38 to 2.4)
0.94
QRS period >130 ms
1.15 (0.85 to 1.87)
0.24
Extreme LV systolic dysfunction
1.7 (0.22 to 12.9)
0.62
Historical past of IHD
1.38 (0.45 to 4.3)
0.57
Diabetes
1.63 (0.57 to 4.7)
0.37
VVI pacemaker implanted
8.4 (3.3 to 21.6)
<0.001
7.1 (2.5 to twenty.6)
<0.001
Key: CI = confidence interval; HR = hazard ratio; IHD = ischaemic coronary heart illness; LV = left ventricle; VVI = single chamber
Dialogue
In nonagenarians present process emergency pacemaker implantation for CHB, we discovered an affiliation between dual-chamber pacing and improved symptomatic and prognostic outcomes versus single-chamber pacing. Implanting physicians had an inclination to pick out frailer sufferers for single-chamber pacing, and whereas the noticed variations in post-implant exercise ranges and all-cause mortality is likely to be anticipated given this divergence in sufferers’ useful baseline, adjusted evaluation urged that the choice to institute non-physiological pacing was independently related to adversarial outcomes.
As anticipated in a cohort with CHB, the ventricular pacing share was excessive, however, importantly, didn’t differ between teams. As such, the variations in mortality – and particularly demise from CCF – are much less more likely to be defined by pacing-induced ventricular dysfunction, and will as a substitute relate to asynchronous ventricular pacing from single-chamber gadgets. By preserving chronotropic response and avoiding retrograde atrial activation, dual-chamber gadgets with atrial monitoring have been proven to extend cardiac output by a mean of 800 ml per minute.2 Accordingly, within the current research, sufferers implanted with dual-chamber pacemakers maintained considerably larger imply coronary heart charges, and had decrease imply respiratory charges, than their single-chamber counterparts. Moreover, the burden of atrial pacing seen in dual-chamber pacemaker recipients was comparatively low (22%), suggesting that almost all of our nonagenarian sufferers retain good sinus node perform – this additional helps the advantages of atrial monitoring for delivering not solely synchronous AV pacing, but in addition physiological coronary heart charge variability, even in very outdated sufferers.
Notably, our findings distinction with these of the PASE, CTOPP and UKPACE randomised-controlled trials. As a retrospective evaluation, the authors acknowledge that the current research outcomes are vulnerable to bias and random probability, nonetheless, there are additionally necessary distinctions in research design and inhabitants, which may account for the disparate outcomes. To start with, temporal adjustments in life-expectancy – and, therefore, the diploma of profit conferred from physiological pacing – might account for variations within the distribution of adversarial occasions between trials. Moreover, whereas the current research solely recruited members with CHB, the PASE and CTOPP trials randomised sufferers with each AV block and sinus node illness, and the UKPACE trial included 26% of sufferers with second-degree AV block; this may increasingly have resulted in vital variations in each pacing burden and mode between research. Importantly, the CTOPP and PASE trials didn’t document the share of ventricular pacing in the course of the follow-up interval, and these information have been additionally lacking in one-third of sufferers within the UKPACE trial. We advise that, when inspecting scientific outcomes, share pacing burden is an crucial metric given the affiliation between proper ventricular pacing and subsequent systolic dysfunction, and we suggest that the potential for decrease than anticipated ventricular pacing burden within the single-chamber gadget arms might have decreased the incidence of adversarial occasions in these trials.13 Lastly, given the necessities for knowledgeable consent and affordable prognosis (i.e. life-expectancy of >1 12 months) to take part in these randomised trials, it’s probably that the examined members have been much less frail than the current research’s real-world inhabitants, and maybe, due to this fact, much less vulnerable to the deleterious results of asynchronous pacing from single-chamber pacemakers.
Observational research have beforehand reported single-chamber pacemaker implant charges as excessive as 80% in nonagenarians.10 Whereas our physicians preferentially chosen frailer sufferers for single-chamber gadgets, this solely comprised 13% of our cohort. This displays information from Greenspon et al. (2012) who, in a big US registry research, reported a development in direction of using dual-chamber pacemakers; by 2009, solely 14% of implanted pacemaker gadgets have been single-chamber, down from 36% in 1993.14
Though giant research have examined the feasibility and security of pacemaker implant in sufferers over 90 years of age,15 to our data, we current the very best quantity examination of a nonagenarian cohort with solely CHB, and in addition the primary research to incorporate solely emergency procedures. Whereas these procedures symbolize solely 2.3% of our CIED case load, that is an increasing affected person group with a paucity of information relating to gadget choice. Procedural problems on this cohort can show notably grave, therefore, it’s vital that the choice to proceed to dual-chamber implant be evidence-based.
Limitations
As a single-centre evaluation, our outcomes might not be generalisable to the broader inhabitants, nonetheless, our inhabitants was drawn from a catchment space of 4 million people through 11 totally different referring hospitals, so we recommend that the ultimate cohort is heterogeneous. The comparatively excessive occasion charge was enough to facilitate multi-variate evaluation adjusting for necessary confounders, nonetheless, unequal group sizes precluded sure subanalyses. Whereas the Rockwood scientific frailty scale is a quantitative metric, bedside evaluation of frailty is subjective, and the printed information might not actually mirror sufferers’ useful standing in all circumstances. There was a very excessive incidence of demise from CCF in sufferers with single-chamber pacemakers; though this was recorded from members’ demise certificates, post-mortem information was not obtainable for adjudication. It’s attainable that sufferers’ group medical doctors have been biased by the current cardiac historical past of pacemaker insertion, and, due to this fact, recorded ‘CCF’ because the almost definitely explanation for demise within the absence of a extra believable rationalization, giving rise to a falsely elevated occasion charge. The speed of problems in sufferers receiving dual-chamber pacemakers was low (2.1%) and might not be consultant of the broader inhabitants; importantly, larger complication charges would possibly affect operator decision-making relating to single- versus dual-chamber pacing. Lastly, as a retrospective evaluation, this research was not designed to evaluate causation and might solely be speculation producing; it’s attainable that not all vital confounders have been accounted for within the multi-variate modelling.
Conclusion
In nonagenarians presenting in an emergency with CHB, dual-chamber pacing was independently related to beneficial long-term symptomatic and prognostic outcomes versus single-chamber pacing, with the same incidence of procedural problems between teams. Our information add additional assist to the routine use of dual-chamber gadgets on this increasing cohort, nonetheless, a randomised-controlled trial can be required to exhibit a causal relationship.
Key messages
Information on gadget choice and outcomes for nonagenarians with full coronary heart block (CHB) are restricted
Twin-chamber pacing was related to improved symptomatic outcomes in contrast with single-chamber pacing in nonagenarians with CHB
Single-chamber pacing was related to elevated threat of all-cause mortality and demise from congestive cardiac failure in contrast with dual-chamber pacing in nonagenarians with CHB
Conflicts of curiosity
None declared.
Funding
None.
Research approval
The research was registered with the native scientific effectiveness unit; as this was a retrospective evaluation of registry information for the needs of high quality assurance, the necessity for formal moral approval was waived by our establishment.
References
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