THE INFLUENCE OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE UPON CLINICAL OUTCOMES AND QUALITY OF LIFE IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION. THE EFFECTS OF DIFFERENT ACCESS ROUTE APPROACHES.

Objectives: Main objectives of this study were: 1) to evaluate the impact of chronic obstructive pulmonary disease (COPD) upon clinical outcomes and quality of life (QoL), in patients undergoing transcatheter aortic valve implantation (TAVI) for severe symptomatic aortic valve stenosis (AS); 2) to describe the various surgical and percutaneous access routes available for TAVI; 3) to evaluate the effects of access route on clinical results and QoL in patients with COPD undergoing balloon-expandable TAVI via different access routes (transfemoral, transapical and transaortic). Background: Catheter-based therapies represent potentially transformational technologies for valvular heart disease. With evidence of feasibility, safety and mortality benefit established, a clearer definition of comorbid conditions that adversely affect survival despite successful valve implementation is becoming mandatory. Similarly, quality of life and health economic assessment is crucial, so that this therapy is appropriately used in patients likely to benefit compared with those unlikely to improve despite technical success. There are very few data about symptomatic improvement in patients with COPD, whose main symptom is dispnea as AS’ is, and where nothing is often really accomplished. One of the unique variables for successful TAVI involves the ability to secure an access route for deployment of the aortic prosthesis. The effects of access route approaches upon QoL are even less clear. Methods: A prospective analysis was performed upon data from 285 consecutive patients receiving transfemoral (TF), transapical (TA) or transaortic (TAo) TAVI. Patients were confirmed and stratified with regard to lung disease severity on the basis of pulmonary function test results and data on oxygen-dependency. QoL was assessed using the self-reported European Quality of Life-5 Dimensions (EQ-5D) questionnaire. In order to assess the effect of COPD on outcomes following TAVI, patients were organized into mutually exclusive groups according to pulmonary disfunction (nonCOPD and COPD) and according to airflow limitation severity in COPD patients (mild and moderate to severe COPD [modsevCOPD]). Results: Based on spirometry, 58 (20%) patients were affected by moderate to severe COPD (median FEV1/FVC 0.65 [IQR 0.57-0.72]), with a median FEV1 of 58% (IQR 51-70%). All kinds of access routes were used in modsevCOPD patients with rates comparable to nonCOPDs. Notwithstanding a higher peri-operative risk, the COPD cohort had comparable procedural success, 30-day and 1-year mortality as the nonCOPD cohort. No statistical difference was noted between the two groups in terms of respiratory complications neither in terms of post-procedural Intensive/Coronary Care Unit stay and overall in-patient stay. Overall mortality at the median follow-up of 27 months was higher in COPD patients (p Log-Rank <0.01). COPD was an independent predictor of late follow-up cumulative mortality after TAVI (HR: 1.80; 95% CI: 1.07 to 3.03; p=0.03). Improvement in functional status and QoL was observed after TAVI in both groups (p <0.01 for NYHA, EQ-5Dindex and EQ-5DVAS). COPD patients exhibited as few problems in any EQ-5D domain as nonCOPD patients and comparable EQ-5Dindex,EQ-5DVAS, absolute improvement from baseline (ΔEQ-5Dindex and ΔEQ-VAS) and NYHA class at 30 days and 1 year. Among modsevCOPD, QoL improvement after TAVI resulted dependent on the access route only at 30 days, when the nonTF-TAVI patients reported more problems (lower ΔEQ-5Dindex improvement, p=0.04). TF-TAVI and baseline mean transvalvular gradient best determined the likelihood of benefit after TAVI (Hosmer-Lemeshow goodness-of-fit test: 4.74 with 7 df, p=0.69). Conclusions: Considered clinical and QoL results, this study demonstrated that TAVI represents an appropriate, effective and safe therapy in high-risk patients with both severe AS and COPD. This study confirmed the importance of recognizing preexisting severe COPD before making operative decisions in such patients, in order to allocate medical resources to patients who have a bare possibility to regain fulfillment from activities of daily living. In COPD patients with moderate to severe disease, the probability of QoL improvement at 30 days and at 1 year resulted to be independent on the access route other than at 30 days, when the transfemoral access was shown to be a strong predictor of QoL improvement.