Quality of life assessment in patients undergoing trans-catheter aortic valve implantation using MacNew Questionnaire

The MacNew questionnaire is a disease-specific quality of life measure that has been used in patients with myocardial infarction and heart failure. We aimed to investigate the impact of transcatheter aortic valve implantation (TAVI) on health-related quality of life (HRQoL) using MacNew Questionnaire and identify predictors associated with a change in its score. This was a prospective multi-center study performed across 5 National Health Service hospitals in the United Kingdom performing TAVI between 2016 and 2018. HRQoL was assessed using MacNew Questionnaire, Euro Quality of Life-5D-5L, and Short Form 36 questionnaires collected at baseline, 3-, 6- and 12 months after the procedure. Out of 225 recruited patients, 19 did not have TAVI and 4 withdrew their consent, and hence 202 patients were included. HRQoL was assessed in 181, 161, and 147 patients at 3, 6, and 12 months, respectively. Using MacNew, there was a significant improvement in all domains of HRQoL as early as 3 months after TAVI which was sustained up to 12 months with improved discrimination of change in HRQoL compared with other scales. Poor mobility at baseline and history of myocardial infarction were independent predictors of reduced improvement in HRQoL at 3 months. HRQoL increased in all subgroups of patients including frail ones. In conclusion, the MacNew assessment tool performed well in a representative TAVI cohort and could be used as an alternative disease-specific method for assessing HRQoL change after TAVI

Effect of transcatheter aortic valve implantation vs surgical aortic valve replacement on all-cause mortality in patients with aortic stenosis

Importance: Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to surgical aortic valve replacement and is the treatment of choice for patients at high operative risk. The role of TAVI in patients at lower risk is unclear. Objective: To determine whether TAVI is noninferior to surgery in patients at moderately increased operative risk. Design, Setting, and Participants: In this randomized clinical trial conducted at 34 UK centers, 913 patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk due to age or comorbidity were enrolled between April 2014 and April 2018 and followed up through April 2019. Interventions: TAVI using any valve with a CE mark (indicating conformity of the valve with all legal and safety requirements for sale throughout the European Economic Area) and any access route (n = 458) or surgical aortic valve replacement (surgery; n = 455). Main Outcomes and Measures: The primary outcome was all-cause mortality at 1 year. The primary hypothesis was that TAVI was noninferior to surgery, with a noninferiority margin of 5% for the upper limit of the 1-sided 97.5% CI for the absolute between-group difference in mortality. There were 36 secondary outcomes (30 reported herein), including duration of hospital stay, major bleeding events, vascular complications, conduction disturbance requiring pacemaker implantation, and aortic regurgitation. Results: Among 913 patients randomized (median age, 81 years [IQR, 78 to 84 years]; 424 [46%] were female; median Society of Thoracic Surgeons mortality risk score, 2.6% [IQR, 2.0% to 3.4%]), 912 (99.9%) completed follow-up and were included in the noninferiority analysis. At 1 year, there were 21 deaths (4.6%) in the TAVI group and 30 deaths (6.6%) in the surgery group, with an adjusted absolute risk difference of −2.0% (1-sided 97.5% CI, −∞ to 1.2%; P < .001 for noninferiority). Of 30 prespecified secondary outcomes reported herein, 24 showed no significant difference at 1 year. TAVI was associated with significantly shorter postprocedural hospitalization (median of 3 days [IQR, 2 to 5 days] vs 8 days [IQR, 6 to 13 days] in the surgery group). At 1 year, there were significantly fewer major bleeding events after TAVI compared with surgery (7.2% vs 20.2%, respectively; adjusted hazard ratio [HR], 0.33 [95% CI, 0.24 to 0.45]) but significantly more vascular complications (10.3% vs 2.4%; adjusted HR, 4.42 [95% CI, 2.54 to 7.71]), conduction disturbances requiring pacemaker implantation (14.2% vs 7.3%; adjusted HR, 2.05 [95% CI, 1.43 to 2.94]), and mild (38.3% vs 11.7%) or moderate (2.3% vs 0.6%) aortic regurgitation (adjusted odds ratio for mild, moderate, or severe [no instance of severe reported] aortic regurgitation combined vs none, 4.89 [95% CI, 3.08 to 7.75]). Conclusions and Relevance: Among patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk, TAVI was noninferior to surgery with respect to all-cause mortality at 1 year. Trial Registration: isrctn.com Identifier: ISRCTN57819173