REB Protocol Version 4, May 20, 2020

REB No: 00038830

REB Protocol

Title of the Capstone Project:

Improving the Uptake of TAVR In Ontario

Student Principal Investigator

Name: Abimbola. K. Saka M.D
Tel:
Email:

Translational Research Program Advisor Name:

Joseph Ferenbok Ph.D.
Tel:
Email:

Advisory Committee Members

Name: Michael Farkouh M.D
Tel:
Email:

Name: Harindra C. Wijeysundera M.D.

Tel:
Email:

Name: Neil Fam M.D

Tel:
Email:

Name: Laura Hartman Ph.D. OT Reg. (Ont.)

Tel:
Email:

Name: Maral Ouzounian M.D

Tel:
Email:
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What is Aortic Stenosis?

Aortic stenosis occurs when the normal blood flow across the aortic valve is impaired
either due to calcium deposits, congenital disability, or an infection such as Rheumatic Fever. In
individuals aged 65 years and above, aortic stenosis is mostly due to calcium accumulation in the
valve. Known for its poor prognosis, Aortic Stenosis has a 1-year survival rate of about 60%, and
a 5-year rate of about 32% (Joseph, Naqvi, Giri, & Goldberg, 2017).
Individuals with Aortic Stenosis often present with chest pain, shortness of breath,
fainting spells, and difficulty breathing during physical exertion. According to the American
Heart Association/American College of Cardiology guidelines (Nishimura et al., 2017), the
recommendations to perform either transcatheter aortic valve replacement or surgical aortic
valve replacement, are:
1. Symptomatic severe Aortic Stenosis
2. Asymptomatic severe aortic stenosis undergoing Coronary Artery Bypass Graft
3. Asymptomatic severe aortic stenosis undergoing heart valve or aortic surgery, and;
4. Asymptomatic severe aortic stenosis with ventricular systolic dysfunction with an
ejection fraction less than 50%
The incidence of Aortic Stenosis increases with age, with about 29% of cases occurring
in individuals aged 65 and older, and about 37% occurring at ages 75+ years (Nishimura et al.,
2017). In Canada, the prevalence of valvular diseases collectively is 2.5% at age 75years and
0.4% at age 80 years (Kingsbury et al., 2012). However, for aortic stenosis specifically, the
prevalence is 2.0% at age 75 years and 8.1% at age 85years, accounting for the most common
form of valvular diseases (Kingsbury et al., 2012).

What Is The Current Treatment For Aortic Stenosis?

Valve replacement is the only definitive treatment for severe Aortic Stenosis. Since 1986,
the recommendation for the management of aortic stenosis has been an open-heart procedure
known as Surgical Aortic Valve Replacement (SAVR). In addition to this, the guideline
recommends performing surgical valve replacement immediately after patients present with
symptoms (Bonow, 2011).
While SAVR is known to be an effective therapy for the management of severe aortic
stenosis, multiple surveys such as the EuroHeart survey of 2004, have revealed that more than a
quarter of patients eligible for surgery are denied surgery and left untreated (Cribier, 2014). The
reason for this denial is due to multiple factors such as comorbidities and advanced age, which
puts these patients at risk for surgical complications. Many people suffering from aortic stenosis
were deemed inoperable due to the operative morbidity and mortality associated with open-heart
surgery. Being over the age of 70 alone was a sufficient criterion to be denied SAVR in the
1980s (Cribier, 2014).
In response to the limitations to providing patients with the best practice interventions
due to complications associated with surgery, a less invasive procedure – Transcatheter Aortic
Valve Replacement (TAVR) - was developed. TAVR is a minimally invasive and effective
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procedure used to treat symptomatic severe aortic stenosis at high surgical risks and with
underlying comorbidities. After several years of animal testing, TAVR was used successfully in
humans for the treatment of symptomatic severe aortic stenosis with comorbidities, in 2002
(Cribier, 2014). TAVR made valve replacement a possibility for these individuals, becoming the
preferred procedure in cases where open-heart surgery carries substantial risks. Today, TAVR is
the recommended procedure in some cases of severe Aortic Stenosis and serves as a safer
alternative to (SAVR), especially in high-risk patients (Asgar et al., 2019).
The benefit of TAVR is well established that the American College of Cardiology (ACC)
and American Heart Association (AHA) guidelines deemed the old standard of care – SAVR –
no longer a safe option for moderate to high risk patients with severe aortic stenosis and
comorbidities. The guidelines recommend TAVR in the "moderate to high-risk patients,"
considering multiple factors such as surgical risk, patient fragility, comorbid conditions, and
patient preferences and values (Nishimura et al., 2017).

What Are We Trying To Do?

Despite an increased rate of Transcatheter Aortic Valve Replacement (TAVR) since
2011, with 28 TAVR centers in Canada, except for two provinces (Saskatchewan and
Newfoundland), there is yet an observed asymmetry in the uptake of TAVR across Canada
institutions when compared to other developed countries (Asgar et al., 2018). With comparable
benefits and lower risks of complications compared to surgical aortic valve replacement
(SAVR), TAVR is the preferred alternative therapy in low to high-risk patients not eligible for
surgery (Nishimura et al., 2017). Additionally, the recent study conducted by (Kolte et al., 2019)
and the 2017 updated AHA/ACC guideline on aortic stenosis are clear on TAVR benefits in low
to high-risk symptomatic patients with severe aortic stenosis (Nishimura et al., 2017). Given its
established safety and effectiveness (Asgar et al. 2019), Improving the uptake of TAVR across
Canada institutions can lead to an improved health outcome for patients with severe aortic
stenosis. This capstone project aims to:
1. To understand the principle reasons why SAVR is chosen over TAVR; and
2. To develop an evidence-based intervention to promote TAVR as the preferred alternative
in patients deemed intermediate to high risk for surgery.

How Will The Project make A Difference In Patient's Lives?

This capstone project will contribute to the understanding of the dissemination,
implementation, and adoption of new standards of care. It will provide insights into the
development and implementation of possible interventions to expedite the adoption of new
practices and improve the rate of TAVR over SAVR in Ontario- to lower the risk of
complications for intermediate to high-risk patients with severe aortic stenosis.
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Subject Population
Participants will be identified through a partner organization healthcare provider database
and recruited to participate in the survey. This survey will be sent on behalf of the research team
by a partner organization's cardiac department using a healthcare database to the participants
involved in the decision-making process for Aortic Stenosis therapies.
Study Design: A Mixed method
The research method has three phases; an online survey, a co-design session to
explore the decision-making behind performing either SAVR or TAVR therapies. and a pilot
phase to test and evaluate the intervention developed
Phase one (Survey): Adapting the validated survey from the study conducted by (Bailey,
Toner, & Corcoran, 2020), we developed a survey to understand the characteristics of the
decision-makers and the reasons why one therapy is preferred over another- after conducting a
thorough literature search and evaluation of validated surveys.
The link to the electronic survey will be sent via email to 385 identified decisionmakers
(interventional cardiologists, surgeons, nurses, and organization's heart team) for TAVR and
SAVR across hospitals in Ontario using the healthcare database of a partner institution. The
survey sample size of 385 was selected based on a 95% confidence level, 5% margin of error,
and a population proportion of 50%.
For identifying participants, an initial email will be sent by a partner organization's
cardiac department via the database listing of the healthcare team, interventional cardiologist,
and surgeons deciding for either TAVR or SAVR. Two follow-up emails will be sent to the same
database listing at a one-week interval to remind participants to complete the survey. The survey
will close after one month of the initial email.
The online survey will inquire about the characteristics of the decision-makers, their
knowledge of the procedure, their behaviors regarding the use of TAVR and SAVR, and aspects
of the decision-making process for referral to SAVR and/or TAVR. At the end of the online
survey, we will ask participants if they would be willing to participate in a 2hrs 30 minutes
codesign session to develop an intervention to improve the uptake of TAVR. If so, they will be
prompted to provide their email address. Personal information will not be collected unless
participants agree to participate in the co-design session.
At one month, the survey responses will be gathered and analyzed by the research team
using the descriptive analysis to note the mean, standard deviation for continuous variables, and
the frequencies for categorical variables using SPSS. Statistical package of social sciences
(SPSS) is a software used in the statistical analysis of data.

Inclusion and Exclusion Criteria Inclusion

Criteria:
1. Individuals who self-select as decision-makers for SAVR or TAVR Exclusion
Criteria:
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1. Individuals not involved in the decision making for SAVR or TAVR Participants
will be asked to:
1. Read and sign the consent form
2. Asked to complete the online survey questions
3. Asked for their interest in participating in the co-design session to develop an
intervention to improve the uptake of TAVR

Data Collection and Analysis

Collection: All identifiable information will be kept strictly confidential. Names, ids,
email addresses, profession, specializations, demographics will not be shared unless participants
give additional consent. Data collected will be assigned ID's that will only be accessible to the
research team. The anonymity of participants will be protected when reporting results obtained
from this study (i.e., demographic variables will be summarized, and no individual data will be
available to the University of Toronto). The survey data will not include identifiable
information such as; name, age, email addresses, and sex. Demographic details
summarized will consist of the year of practice, institutional practice type, institutional
setting, and specialty. Only participants with an expressed interest in the co-design session
will be asked to provide their email addresses. Emails will be collected solely to contact
interested participants and deleted after the co-design session.
Data Analysis: the research team will analyze survey data by descriptive analysis using
SPSS. Descriptive statistics will include the mean, range of responses collected. The results will
inform the intervention that will be developed in phase two.

Phase two (Co-design session): will involve a co-design session with a group of respondents
Using the implementation for change model by Zipfel et al., we will develop an intervention to
improve the uptake of TAVR. The co-design session will mitigate the "why" to the responses
gathered from the survey. The implementation for change model is a checklist that highlights the
different stages of change management and its impact at various levels of an organization (Zipfel
et al., 2019).
We will recruit ten respondents who meet the predefined criteria for the co-design
session. The predefined criterion for selection is that participants must have an active role in the
decision making of TAVR and must have completed the online survey in phase one of the
research. An invitation with the details and structure of the co-design session will be provided to
participants via email. This session will be facilitated by the student PI (Abi) and recorded for
accuracy using the student PI's desktop. All recordings will be stored electronically on
SharePoint and will be deleted after analysis.
We will ask the virtual co-design session participants to type In their responses
electronically. All electronic responses will be collected on an excel file, assigned id's and stored
on Sharepoint. The data stored on Sharepoint will be kept for up to 1 year and securely
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removed/deleted after the research is complete and in compliance with the University of
Toronto's regulations.
The co-design session will be a two and a half-hour session broken into:
An introduction of the facilitator and the participants. Detail description of co-design session
goals, key activities, the overall result of the first phase of the project, and informed consent to
audio-record, transcribe and analyze participation
Discussion around the barriers, facilitators, and decision determinants (see figure 1.) of TAVR
and SAVR- The facilitator (Abi) will initiate a conversation around the barriers, facilitators, and
the decision determinants of TAVR and SAVR identified from the survey results
General idea gathering for improving TAVR adoption- we will ask each participant to type in
ideas that come to mind when thinking of facilitators to change
Specific idea gathering for promoting TAVR adoption-we will ask each participant to narrow
down their ideas specifically to TAVR
Synthesis and mapping of each concept to the identified barriers to developing a testable
intervention. At the end of the co-design session, we will then test and evaluate the intervention
designed amongst a few stakeholders with the intention of broader implementation

Participant Sampling
We will select participants for the co-design session through a mix of criterion sampling-
a method of choosing participants who meet a predefined criterion (Patton, 1990). The criterion
for selection is that participants must have an active role in the decision making of TAVR and
must have completed the online survey in phase one of the research. Participation in the codesign
session will take place virtually.

Data Collection and Analysis

Collection: All identifiable information will be kept strictly confidential. No names, ids,
email addresses, profession, specializations, demographics will be shared unless participants give
additional consent. Data collected will be assigned ID's that will only be accessible to the
research team. Email addresses will be deleted after the co-design session.
The co-design session will be audio-recorded for accuracy. We will permanently delete
the audio recordings after analysis. The anonymity of participants will be protected when
reporting results collected from this study (i.e., demographic variables will be summarized, and
no individual data will be available to the University of Toronto).
Data Analysis: We will analyze the data collected during the co-design session by
thematic analysis using NVIVO to organize the data.

Phase three (Pilot Testing): will involve an evaluation of the intervention in a survey format of
five decision-makers to identify if the intervention works and if this will change or impact their
decision making using the following parameters; usability, effectiveness, and adaptability. The
survey link will be sent by email to five participants who meet the predefined criterion.
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The predefined criterion is that a participant must be a decision-maker and must have
participated in phase one of the research. Two follow-up emails will be sent at a one-week
interval to remind participants to complete the survey. The survey will close after three weeks of
the initial email.
At three weeks, the survey responses will be gathered and analyzed by the research team using
the descriptive analysis to note the mean responses using SPSS. Feedback obtained will be used
to improve the intervention.

Data Collection and Analysis

Collection: Collection: Data collection for the study will be through the surveys, and the
co-design session. Participants will complete the survey anonymously, and they will be asked
both open and closed-ended questions with regards to their use of TAVR based on the strategies
developed. Name, ids, email addresses, profession, specializations, demographics will not be
shared unless participants give additional consent. Data collected will be assigned ID's that will
only be accessible to the research team. The anonymity of participants will be protected when
reporting results obtained from this study (i.e., demographic variables will be summarized, and
no individual data will be available to the University of Toronto). The survey data will not
include identifiable information such as; name, age, email addresses, and sex. Demographic
details summarized will consist of the year of practice, institutional practice type,
institutional setting, and specialty. Only participants with an expressed interest in the
codesign session will be asked to provide their email addresses. Emails will be collected
solely to contact interested participants and deleted after the co-design session.
Analysis: the research team will analyze survey data by descriptive analysis using SPSS.

Privacy
All identifiable information will be kept strictly confidential. Names, ids, email
addresses, profession, specializations, demographics will not be shared unless participants give
additional consent. The data collected will be stored in a secure excel file and stored in
Sharpoint- a secure way of transferring data.
The data stored on Sharepoint will be kept for up to 1 year and securely removed/deleted
after the research is complete and in compliance with the University of Toronto's regulations.
All physical forms will be kept in a file and stored in a secure safe, and all data stored on
SharePoint will be password protected.

Sponsor
This capstone project is not sponsored. However, a total sum of $1000 will be made
available by the Translational program for administrative costs. The team will not profit
financially from this project.
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Reimbursement and Compensation

There is no reimbursement associated with participating in this project. We will give each
participant in the co-design session a $25 gift card as an honorarium for their time.

Appendix

Figure 1: Co-design session-

evaluation of the decision
determinants obtained from
the survey data. Patient preference
and values ( feedback
from clinicians)

Physician preference
and values Economic impact:
availability of funding

Clinical factors:
Guidelines
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Works Cited

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