Background:

While the importance of patients’ quality of life (QoL) in heart failure is increasingly been acknowledged and has become a treatment target, the burden of pulmonary embolism (PE) on patients’ QoL has received little attention thus far.

We aimed to i) validate the German version of the disease-specific Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire, ii) identify associations between QoL and both, clinical and functional parameters assessed at 6-month follow-up after an acute PE and iii) investigate the prognostic relevance of QoL.

Methods:

Patients with confirmed PE enrolled in a prospective single-centre cohort study between 01/2011 and 08/2013 were invited to a clinical 6-month follow-up visit. QoL was assessed with the German version of the PEmb-QoL questionnaire including six dimensions (categories) of questions. Internal consistency reliability, construct related validity and regressions between PEmb-QoL and clinical patient characteristics were assessed using standard-scale construction techniques. QoL was set in relation to baseline characteristics, clinical examination results at follow-up, socio-economic status and long-term mortality. Long-term (all-cause) mortality during median follow-up period of 3.6 years (IQR, 3.1-4.5) was ascertained by checking vital status of all patients through the population registries of Germany.

Results:

Overall, 101 patients (median age, 69 [IQR 57-75] years, 48.5% females) were examined 208 (185-242) days after the acute PE. The questionnaire was completed by 86%.

Internal consistency reliability was adequate (Cronbach’s α=0.77-0.91), except for the dimension “intensity of complaints” (α=0.54). Construct related validity showed acceptable associations of single items with the proposed scores, but dimensions revealed distinct floor effects (12.0-59.2%).
In total, 12.9% of patients were diagnosed with post-thrombotic syndrome, 4.0% with CTEPH and 5.9% had new diagnosis of cancer; no patient suffered from recurrent PE. As much as 18.8% of patients reported dyspnoea in NYHA class III/IV, 25.3% were diagnosed with “post-PE impairment” (defined as combination of clinical, echocardiographic and laboratory parameters) and 15.7% with depression at follow-up.

While PEmb-QoL dimensions were not affected by depression, cancer and RV dysfunction on echocardiography at follow-up and only slightly by patients’ socio-economic status, “post-PE impairment” was associated with “work-related problems” (OR 3.4 [95%CI 1.1-10.8]; p=0.041), and persisted dyspnoea (NYHA III/IV) with all dimensions except “emotional complaints”.

Overall, 12 patients (11.9%) died during the long-term observation period (3.6 [IQR, 3.1-4.5] years). Interestingly, the dimensions “activities of daily living limitations”, “work related problems”, “social limitations” and “emotional complaints” were associated with an increased risk for long-term mortality. In contrast, all other study outcomes at 6-month follow-up including “post-PE impairment” had no relevant impact on long-term survival.

Conclusions:

The German PEmb-QoL questionnaire is a reliable instrument to assess QoL six months after acute PE although the assessment of two dimensions was characterised by large floor effects. QoL was affected by dyspnoea (NYHA III/IV) and “post-PE impairment” at 6-month follow-up and associated with an increased risk for long-term mortality.