A proctoring system to manage the learning curve associated with the introduction of transcatheter aortic valve implantation in Japan View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2017-12-11

AUTHORS

Masahiro Yamawaki, Kiyotaka Iwasaki, Motoharu Araki, Tsutomu Ito, Yoshiaki Ito, Norio Tada, Kensuke Takagi, Futoshi Yamanaka, Yusuke Watanabe, Masanori Yamamoto, Shinichi Shirai, Kentaro Hayashida, On behalf of the OCEAN-TAVI Registry

ABSTRACT

As transcatheter aortic valve implantation (TAVI) requires multidisciplinary collaboration, operators and the entire heart team must overcome a steep learning curve. A web-based screening and traditional on-site proctoring system were developed for the introduction of TAVI in Japan. To assess the learning curve involved with the introduction of TAVI under the supervision of a novel proctoring system. We divided 749 consecutive patients enrolled in the OCEAN-TAVI study between October 2013 and August 2015 into the trans-femoral (TF, n = 608) and transapical (TA, n = 141) approach groups to compare outcomes in patients who underwent TAVI during the early proctoring period (proctoring group) and after the procedures began to be performed independently (independent group). The primary endpoint was the rate of composite events regarding early safety (at 30 days) according to the valve academic research consortium-2 criteria. For TF-TAVI, the logistic EuroSCORE and the rate of peripheral artery disease were significantly lower during the independent period. The rate of device success significantly increased during the independent period (90.5 vs. 81.8%, p = 0.005). The rate of the primary endpoint was significantly reduced during the independent period compared to that during the proctoring period for TA-TAVI (21.3 vs. 37.9%, p = 0.031); however, no difference was observed for TF-TAVI (16.8 vs. 13.1%, p = 0.283). No deaths occurred within 30 days during the proctoring period for TF-TAVI. After adjustment using propensity score matching, the procedure time for TF-TAVI (88 ± 43 vs. 102 ± 36 min, p = 0.004) and the rate of life-threatening bleeding for TA-TAVI (3.6 vs. 25%, p = 0.026) reduced during the independent period compared to the values during the proctoring period. During the introduction of TAVI under the supervision of a new proctoring system in Japan, clinical outcomes and technical aspects improved significantly. There are differences in the steepness of the learning curve between TF-TAVI and TA-TAVI. More... »

PAGES

630-639

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00380-017-1098-9

DOI

http://dx.doi.org/10.1007/s00380-017-1098-9

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1099695075

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/29230569


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25 schema:description As transcatheter aortic valve implantation (TAVI) requires multidisciplinary collaboration, operators and the entire heart team must overcome a steep learning curve. A web-based screening and traditional on-site proctoring system were developed for the introduction of TAVI in Japan. To assess the learning curve involved with the introduction of TAVI under the supervision of a novel proctoring system. We divided 749 consecutive patients enrolled in the OCEAN-TAVI study between October 2013 and August 2015 into the trans-femoral (TF, n = 608) and transapical (TA, n = 141) approach groups to compare outcomes in patients who underwent TAVI during the early proctoring period (proctoring group) and after the procedures began to be performed independently (independent group). The primary endpoint was the rate of composite events regarding early safety (at 30 days) according to the valve academic research consortium-2 criteria. For TF-TAVI, the logistic EuroSCORE and the rate of peripheral artery disease were significantly lower during the independent period. The rate of device success significantly increased during the independent period (90.5 vs. 81.8%, p = 0.005). The rate of the primary endpoint was significantly reduced during the independent period compared to that during the proctoring period for TA-TAVI (21.3 vs. 37.9%, p = 0.031); however, no difference was observed for TF-TAVI (16.8 vs. 13.1%, p = 0.283). No deaths occurred within 30 days during the proctoring period for TF-TAVI. After adjustment using propensity score matching, the procedure time for TF-TAVI (88 ± 43 vs. 102 ± 36 min, p = 0.004) and the rate of life-threatening bleeding for TA-TAVI (3.6 vs. 25%, p = 0.026) reduced during the independent period compared to the values during the proctoring period. During the introduction of TAVI under the supervision of a new proctoring system in Japan, clinical outcomes and technical aspects improved significantly. There are differences in the steepness of the learning curve between TF-TAVI and TA-TAVI.
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32 Japan
33 TA-TAVI
34 TF-TAVI
35 Valve Academic Research Consortium-2 criteria
36 adjustment
37 aortic valve implantation
38 approach group
39 artery disease
40 aspects
41 bleeding
42 clinical outcomes
43 collaboration
44 composite events
45 consecutive patients
46 criteria
47 curves
48 days
49 death
50 device success
51 differences
52 disease
53 early safety
54 endpoint
55 events
56 group
57 heart team
58 implantation
59 independent period
60 introduction
61 introduction of TAVI
62 learning curve
63 life-threatening bleeding
64 logistic EuroSCORE
65 multidisciplinary collaboration
66 operators
67 outcomes
68 patients
69 period
70 peripheral artery disease
71 primary endpoint
72 procedure
73 procedure time
74 propensity score
75 rate
76 safety
77 scores
78 screening
79 steep learning curve
80 steepness
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83 supervision
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86 technical aspects
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