Discussion
This observational single-centre prospective cohort study with 435
patients undergoing TLE showed a high long-term mortality, also after a
complete resolution of CIED infection. With a very long-mortality rate
of 34%, this first analysis on the cause of death-data after TLE,
supported the notion that the survival continues to be burdened by
multiple chronic diseases progression, beyond the clinical resolution of
infection.
In the last two decades, numerous reports of single and multi-centres
experiences outlined mainly positive short-term results, paving the way
for guidelines definition (7). The largest “real-word” prospective
registry confirmed both “acute” safety and efficacy of TLE, with a
complete clinical success of 96.7% and all cause in-hospital deaths of
1.2% in high volume centres (2). Nonetheless, evidences on long-term
mortality after TLE are still scarce, as described by recent studies
focused on “CIED infection”-related predictors of long-term outcomes
after TLE (8–15).
Our results showed how patients undergoing a successful TLE, especially
for an infective cause, remain at high-risk of death at median follow-up
of 54 months due to progression of underlying multiple chronic diseases.
Conversely, the infective cause is the leading cause of death before
discharge. However, it should be noted that, after the initial phase of
short- and medium-term follow-up in which mortality may be due to septic
relapses or complications such as valvular insufficiencies or heart
failure, the mortality of the population could be similar to that of an
equivalent group of patients.
Moreover, we observed a relatively short-time interval to death after
discharge in elderly subjects, in patients with severe CKD and systolic
LV dysfunction.
More in detail, our population is high-risk population with high rates
of comorbidities and 92% of patients with evidence of infection as TLE
indication: as formerly stated, infective indication itself represents a
mortality risk enhancer as showed By Mehta et al. (11). Nonetheless,
clear evidence regarding mortality rates for untreated patients supports
the indication TLE in case of CIED-related infections (20).
With particular regard to long-term predictors, the postprocedural risk
conveyed by age confirms previous findings (12) as also the risk
conferred by chronic kidney disease strongly supported by the
literature, mainly with regard to short-term follow-up (10,12,15,21).
Conversely, long-term data on systolic LV dysfunction after TLE remained
unclear. According to Metha et al (11), our results showed LV systolic
dysfunction as an independent long–term predictor of death at
multivariate analysis in patients undergoing TLE with CIED infection as
indication. Recently, Nishii et al demonstrated that the survival rate
after TLE was not significantly different between patients with LVEF ≤
35% and those with LVEF > 35% at 30 days and 1 year after
TLE. Nevertheless, patients with systolic LV dysfunction were more
likely to require additional hemodynamic support and temporary cardiac
resynchronization therapy pacing after TLE and brain natriuretic
peptide levels as marker of heart failure represented a significant
predictor for 1-year mortality (22).
With regard to lead related data, number of extracted leads or dwelling
time were not significant predictors of mortality in our cohort, but the
impact of leads on long term mortality was more noticeable in the
non-infection group of patients undergoing TLE than in CIED infection
group (11).
As important limitation of our study focused on tertiary care center
dataset, referral bias could have affected the clinical data, thereby
limiting the generalization of our results to other populations.
Our findings suggest the urgent need for a risk score including age at
explant, CKD and reduced LVEF, in larger populations undergoing TLE to
better define not only the risk/benefit analysis of lead extraction and
related follow-up by the multidisciplinary team but also the
cost-effectiveness of this entire clinical pathway (Figure 4). In
particular, risk stratification allows a coherent segmentation that
divides patients into groups with relative service needs is a relevant
foundation for effective, equitable and sustainable care delivery
consistent with a public health perspective. This main clinical
implication is strongly reinforced by the analysis of the costs related
to the TLE procedure which showed a significant economic impact for the
national health service with particular regard for reimplanted patients.
A “risk prediction model” should help optimizing clinical management
since hospital admission, moving toward personalized, patient-centred
medicine. Given the goal of improving outcomes, these assumptions also
imply value-based care considerations in a global health perspective and
economic sustainability.