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Multicenter Study
. 2018 Sep 18;7(18):e009195.
doi: 10.1161/JAHA.118.009195.

Patients Refusing Transcatheter Aortic Valve Replacement Even Once Have Poorer Clinical Outcomes

Tetsuro Shimura  1 , Masanori Yamamoto  1   2 , Seiji Kano  1 , Soh Hosoba  1 , Mitsuru Sago  1 , Ai Kagase  2 , Yutaka Koyama  2 , Satoshi Tsujimoto  2 , Toshiaki Otsuka  3   4 , Norio Tada  5 , Toru Naganuma  6 , Motoharu Araki  7 , Futoshi Yamanaka  8 , Shinichi Shirai  9 , Kazuki Mizutani  10 , Minoru Tabata  11 , Hiroshi Ueno  12 , Kensuke Takagi  13 , Akihiro Higashimori  14 , Yusuke Watanabe  15 , Kentaro Hayashida  16 ; OCEAN‐TAVI Investigators
Affiliations
Multicenter Study

Patients Refusing Transcatheter Aortic Valve Replacement Even Once Have Poorer Clinical Outcomes

Tetsuro Shimura et al. J Am Heart Assoc. .

Abstract

Background Although transcatheter aortic valve replacement ( TAVR ) is the least invasive treatment for patients with symptomatic aortic stenosis, some patients hesitate to undergo the procedure. We investigated the clinical impact of treatment delay after patient refusal of TAVR . Methods and Results We used the Japanese OCEAN (Optimized Catheter valvular intervention) regsitry data of 1542 patients who underwent TAVR . Refusal was defined as at least 1 refusal of TAVR at the time of informed consent. Patients were separated into 2 groups: refusal (28/1542, 1.8%) and non-refusal (1514/1542, 98.2%). We compared the baseline characteristics, procedural outcomes, and mortality rates between the groups. Additionally, data on reasons for refusal and those leading to eventually undergoing TAVR were collected. Age, surgical risk scores, and frailty were higher in the refusal group than in the non-refusal group ( P<0.05 for all). Periprocedural complications did not differ between groups, whereas 30-day and cumulative 1-year mortality were significantly higher in the refusal group than in the non-refusal group (7.1% versus 1.3%, P=0.008 and 28.8% versus 10.3%, P=0.010, respectively). Multivariate Cox regression analysis revealed that TAVR refusal was an independent predictor of increased midterm mortality (hazard ratio: 3.37; 95% confidence interval: 1.52-7.48; P=0.003). The most common reason for refusal was fear (13/28, 46.4%), and the most common reason for changing their mind was worsening heart failure (21/28, 75.0%). All patients in the refusal group decided to undergo TAVR within 20 months (median: 5.5 months). Conclusions Refusing TAVR even once led to poorer prognosis; therefore, this fact should be clearly discussed when obtaining informed consent.

Keywords: Optimized Catheter Valvular Intervention; refusal; transcatheter aortic valve implantation; transcatheter aortic valve replacement; treatment delay.

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Figures

Figure 1
Figure 1
CONSORT patient flow chart and definitions of TAVR refusal. This study enrolled 1613 patients from the OCEAN‐TAVI registry. Of these, 71 patients who underwent non‐elective TAVR were excluded. The remaining 1542 patients were divided into the refusal group and the non‐refusal group. TAVR indicates transcatheter aortic valve replacement.
Figure 2
Figure 2
Kaplan–Meier analysis of all‐cause mortality of patients in the refusal and non‐refusal groups. The cumulative 1‐year mortality rates were significantly higher in the refusal group than in the non‐refusal group.
Figure 3
Figure 3
Kaplan–Meier curve showing cumulative (A>) cardiovascular mortality and (B) non‐cardiovascular mortality in the refusal and non‐refusal groups. A, The cumulative 1‐year cardiovascular mortality rate was significantly higher in the refusal group than in the non‐refusal group. B, The cumulative 1‐year non‐cardiovascular mortality rate was not significantly different between the groups.
Figure 4
Figure 4
Distribution of reasons for (A) refusing TAVR and (B) eventually deciding to undergo TAVR after initial refusal in the refusal group. A, This pie chart summarizes the distribution of reasons for patient refusal of TAVR. B, This pie chart summarizes the distribution of reasons for eventually deciding to undergo TAVR after initial refusal. TAVR indicates transcatheter aortic valve replacement.
Figure 5
Figure 5
Time‐to‐TAVR curves for patients in the refusal group. The figure shows the change in the time course of patient numbers from initial TAVR refusal. All patients decided to undergo TAVR within 20 months after initial refusal (grey). Five of the 28 patients decided to undergo TAVR without AS symptom worsening within 8 months (blue). The number of patients who decided to undergo TAVR because of worsening AS symptoms steadily increased with time (orange). AS indicates aortic stenosis; TAVR, transcatheter aortic valve replacement.
Figure 6
Figure 6
One‐year cumulative mortality of patients in the refusal group. The cumulative 1‐year all‐cause mortality of patients who decided to undergo TAVR with AS symptom worsening (orange) was higher than that of patients who decided to undergo TAVR without AS symptom worsening (blue). AS indicates aortic stenosis; TAVR, transcatheter aortic valve replacement.
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