| Indications for Barostim | DATA | Competition | Scramble | ALL -IN Objection Handling |
|---|---|---|---|---|
|
What is <35%
The EF indication for BAT needs to be equal to or less than this
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What is BeAT-HF
Objective of this trial was to demonstrate safety and efficacy including morbidity and mortality.
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What is Impulse Dynamics
Cardiac Contractility Modulation makes this device
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What is ICD and BeAT-HF
80% of patients had this device already in place during what trial
|
What is:
-Agree there are certain patients you can treat with an optimizer, but maybe it isn't for all of them -What patients do you feel are best for optimizer? -What does there data say about low EF patients? -How do you feel about putting extra leads in the heart? -Have you had to extract a patient with both devices yet? -What patients would be better with no leads in the heart? -Do you have lower EF patients that would benefit from a device? -Would it make sense to offer both devices as part of a program -If you could do BAT in your EP lab by yourself would that change your mind?
We can treat these patients with Impulse Dynamics now and I can do the whole implant
|
|
What is NYHA III or NYHA II with a recent h/o III
This indication specifies what NYHA class the patient must be in on most recent exam
|
What is 25%
Significant reduction in NT-ProBNP was demonstrated by what percent in the BeAT-HF Pivotal Trial Results
|
What is Vagal Nerve Stimulation
This therapy delivers over multiple highways and only approved for epilepsy
|
HF is a highly morbid condition without options and the device addresses a significant unmet need
FDA granted Barostim a Breakthrough Device
Designation for what reason(s) |
What is:
- What would be your main concern with the long term results? Is there something in particular you are worried about? -Do you want to have M&M as a proof on concept or is it really important for you that the patient lives longer? -We have had HTN patient with this device over 10 years and HF patients with the device almost 8 years -A lot of HF patients only have a life expectacy of 5 years….If we can give them 5 good years or 5 more years? -NT-proBNP drop of 25% is a strong predictor of us getting positive M&M data -The FDA was unblinded to our M&M data when the gave us an approval without going to panel so that gives us some confidence. is:
You don't have M&M or long term data on the device
|
|
What is NT-proBNP < 1600 pg/ml
Bloodwork needed for BAT candidate to qualify
|
What is 78% and 14 point
This percentage of patients in the BeAT-HF Trial reported a significantly lower impact of symptoms on their daily lives who Feel Better and point improvement in QOL with BAT was demonstrated
|
What is CRT Leads
Tricuspid regurgitation, infection and occlusion are all side effects of this
|
What is
-Some patients do not do well and reach their therapeutic level -Entresto can lower BP -Compliance -Cost -
Name one disadvantage of Heart Failure Drugs (but do not go head to head with drugs you will not win LOL)
|
What is:
-agree the last thing you want is to be adjusting HF meds -You don't treat HF with medication changes typically but you do treat with devices -Do ICD and BiV patients have heart failure? -What do you do when you see a patient who is having heart failure symptoms - do you evaluate for an upgrade first? -Do you or device clinic follow a patient's alerts on a heart failure diagnostic like Heart Logic, Optivol, or cardiomems? -You already have the tools to identify these patients, but you don't want to be the one controlling their medication changes -Consider this like a BiV upgrade, but it is a 2nd device with nothing else touching the heart and minimal additional risk -Do you think it would be best for us to train Cardiologists or HF docs to put this in?
I don't treat Heart Failure or I want to let HF make these decisions
|
|
What is TRUE
True or False. All indications must be met prior to sending in for pre-authorization
|
What is MACE rate of BeAt-HF Pivotal Trial 97%
Safe Procedures and Potential Reduction in Serious Cardiovascular Events and what was the percentage
|
What is Entresto Writers
We should all be targeting these physicians in our accounts that write scripts for this Rx
|
What is Only if all other 3 indications are met does the patient qualify
Barostim is an option for CRT nonresponders if
|
What is:
-I agree you like many centers across the country are burdened by the work of treating HF What keeps you busy (another take on: what keeps you up at night?) -What you describe as your biggest challenge? -What causes your team to be stretched so thin? -Do you spend more time treating Advanced HF or less advanced class III heart failure -If you don't have time or don't want to treat Class III HF maybe this device isn't for you -Do you think this type of device is better managed by EPs and Cardiologists who treat HF but not advanced HF
Our heart failure team is stretched too thin right now to take anything else on
|
|
What is CRT
Patients are not candidates for this type of therapy
|
What is Conclusion of BeAt-HF Pivotal Trial
BAT is safe, improved the patient-centered symptomatic endpoints of QOL score, exercise capacity, and functional status, and significantly decreased NT-proBNP in patients with NYHA functional class III (or patients with NYHA functional class II who had a recent history of NYHA functional class III), EF #35%, NT-proBNP <1600 pg/ml, and who did not have a Class I indication for CRT.
|
1. leads in the CV
2. CCM must be in sinus rhythm 3. EF 25%-45% (BAT less than or equal to 35%) 4. CCM treats NYHA Class III 5. Has to be charged
Name three disadvantages of CCM vs. Barostim
|
What is
1. Messaging 2. MOA 3. Objection Handling
Three key points Craig wants each of us to follow DAILY
|
What is:
-I agree that M&M data would be nice to have. What other hard endpoints would you like to see? -Do patients care about symptoms? -Is a NYHA class I-II patient easier to manage than a class III -Do you consider NT-proBNP reduction a hard endpoint? -Do you wish we had an arm where the device was turned off? - That is hard to do in a 5 year study with M&M endpoints -Do you want to let other physicians and hospitals get early experience while you wait for M&M -The FDA has been unblinded to all our data when they made a decision to approve without a panel, that gives us some confidence
Barostim does not have hard endpoints 6MHW, MLWHFand NYHA are subjective
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