Barostim™�Anesthesia Reference Guide

950338-001 Rev. B

Patient preparation and equipment required

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Patient preparation

Expectations During Mapping

• Patient will be intubated

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• Procedure performed with patient supine, head rotated toward the contralateral side

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• Rotate intubation tubing toward the contralateral side

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• Arterial line is required for mapping

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• Consider using BIS monitoring
• Patient’s arms will be tucked
• Consider titrating down beta blockers day of procedure if HR <60 bpm

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• Several locations on the carotid artery

may be tested

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• Temporary Blood pressure and Heart Rate reductions of 5-10% of baseline

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• Mapping response typically seen withing 1-2 min of therapy ON

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• Artifact on the ECG monitor

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• Discuss with surgeon prior to administering stimulants if within 10 min of mapping as they may blunt the baroreceptors

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• If desired, convert to standard anesthetics once electrode is sutured in place

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Mapping is testing different locations on the internal carotid artery for a

Barostim therapy response

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Implant & anesthesia procedure flow

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Avg implant time is 60 min.

Phase of anesthesia

Step of implantation

Activation �of Barostim therapy

Approximate timeline

0 min

10 min

40 min

60 min

Functional Baroreflex

Effects of anesthetic agents on the baroreflex and half life

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NOTE: Use of a superficial block or sedation regimen may result in blunting of the baroreflex. It may also result in patient movement during the procedure

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TIVA anesthesia using Fentanyl

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• Consider administration with infusion pump or syringe driver rather than bolus
• Physicians should use their judgment and knowledge of the patient to determine dosages

TIVA anesthesia using Remifentanil

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• Consider administration with infusion pump or syringe driver rather than bolus
• Physicians should use their judgment and knowledge of the patient to determine dosages

Anesthesia using Nitrous Oxide

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• Midazolam may be added to this protocol
• Consider using a pre-emptive antiemetic and/or serotonin antagonist or similar for POVN �(i.e., dexamethasone (Decadron), ondansetron (Zofran) or similar)
• Physicians should use their judgment and knowledge of the patient to determine dosages

Anesthesia using Sevoflurane

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• Consider administration with infusion pump or syringe driver rather than bolus
• Midazolam maybe added to this protocol
• Physicians should use their judgment and knowledge of the patient to determine dosages

Early experience and anesthesia awareness with TIVA regimens

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• 320 clinical trial implants 2005-2009
• Bilateral circumferential dissection of the carotid arteries
• Average implant time: 190 minutes
• 2 reported incidences of anesthesia awareness during the early implant experience
1. Long operative time: 4 hr 20 min
2. Cumulative doses of �anesthetic agents

• 3000+ Clinical Trial / Commercial Implants 2014-present
• Unilateral exposure of the carotid artery to level of the peri-adventitia
• Average implant time: 60 min
• No reported incidences of �anesthesia awareness or cognitive dysfunction

Rheos^TM procedure

Barostim procedure

Thank You

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The Barostim Neo™ System is CE Marked and approved for sale for hypertension patients in Europe. It is also CE Marked and approved for sale for heart failure patients in Europe.

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CAUTION: Federal law restricts this device to sale by or on the order of a physician. See the Instructions for Use 900133-001, https://www.cvrx.com/ifu/ for a complete instruction for use and a description of indications, contraindications, warnings, precautions and adverse events.

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CAUTION: Federal law restricts this device to sale by or on the order of a physician. Humanitarian Device. Authorized by Fede ral law for use in the treatment of resistant hypertensive patients implanted with the Rheos CSL leads. The effectiveness of this device has not been demonstrated.

CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use. For a list of all potential benefits and risks go to www.cvrx.com/benefit-risk-analysis/

CANADA ONLY: Caution: Exclusively for Clinical Investigations

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CVRx, Barostim, BAT, Barostim NEO, Barostim NEO2, BATwire, and Outsmart the heart are all trademarks of CVRx, Inc. ©2022 CVRx, Inc. All rights reserved. All other trademarks are property of their respective owners.

Barostim™ brief summary for physicians

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The Barostim™ System is indicated for the improvement of symptoms of heart failure—quality of life, six-minute hall walk and functional status—for patients who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction ≤ 35%, a NT- proBNP < 1600 pg/ml and excluding patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines.

Patients are contraindicated if they have been assessed to have bilateral carotid bifurcations located above the level of the mandible, baroreflex failure or autonomic neuropathy, uncontrolled symptomatic cardiac bradyarrhythmias, carotid atherosclerosis that is determined by ultrasound or angiographic evaluation greater than 50%, ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation, known allergy to silicone or titanium.�

Warnings include: only trained physicians may use this system, prescribing physicians should be experienced in the diagnosis and treatment of heart failure and should be familiar

with the use of this system, monitor blood pressure and heart rate during Carotid Sinus Lead placement and when adjusting stimulation parameters intra-operatively, post- implantation, program the system to avoid the following: heart rate falls below 50 beats per minute (BPM), or systolic pressure falls below 90 mmHg, or diastolic blood pressure falls below 50 mmHg, or problematic adjacent tissue stimulation is noted, or undesirable interaction indicated by monitoring of any other implanted electrical device (see “Device Interaction Testing” in Section 10), or any other potentially hazardous patient responses are observed. Patients implanted with the system may receive Magnetic Resonance Imaging (MRI) only when all MR Conditional safety parameters are met as listed in the instructions for use.. Improper system implantation could result in serious injury or death. Do not use diathermy therapy including shortwave, microwave, or therapeutic ultrasound diathermy on patients implanted with the system. Patients should be counseled to stay at least 15 cm (6 inches) away from devices with strong electrical or magnetic fields such as strong magnets, loudspeaker magnets, Electronic Article Surveillance (EAS) system tag deactivators, arc welders, induction furnaces, and other similar electrical or electromechanical devices. This would include not placing items such as earphones in close proximity to the implanted pulse generator. The IPG may affect the operation of other implanted devices such as cardiac defibrillators, pacemakers, or neurological stimulation systems. For patients who currently have an implanted electrical medical device, physicians must verify compatibility with the implanted device during implantation of the system. Contralateral implant of the Barostim NEO IPG may help to reduce potential interactions. Interactions are more likely in devices that contain a sensing function, such as an implantable cardiac defibrillator or pacemaker. If an interaction is observed, the Barostim NEO IPG should be programmed to reduced therapy output settings in order to eliminate the interaction. If necessary, change settings in the other implant only if the changes are not expected to negatively impact its ability to perform its prescribed therapy. During the implant procedure, if device interactions cannot be eliminated the Barostim System should not be implanted.�

Precautions include: the system should be implanted and programmed carefully to avoid stimulation of tissues near the electrode or in the area of the IPG pocket. Such extraneous stimulation could involve the following: the regional nerves, causing laryngeal irritation, difficulty swallowing, or dyspnea, the cervical musculature, causing intermittent contraction, skeletal muscles, causing intermittent contraction around the IPG pocket. Proper sterile technique during implantation should be practiced and aggressive pre-operative antibiotics are recommended. Infections related to any implanted device are difficult to treat and may necessitate device explantation.

It is anticipated that subjects will be exposed to operative and post-operative risks similar to related surgical procedures involving the neck and/or a pacemaker implant. These risks

and potential risks of chronic device based baroreflex activation may include, but are not limited to: stroke, transient ischemic attack (TIA), systemic embolization, surgical or anesthetic complications, infection, wound complications, arterial damage, pain, nerve damage/stimulation, hypotension, hypertensive crisis, respiratory, exacerbation of heart failure, cardiac arrhythmias, tissue erosion/IPG migration, injury to baroreceptors, fibrosis, allergic reaction, general injury to user or patient, need for reoperation, secondary operative procedure, and death�

CAUTION: Federal law restricts this device to sale by or on the order of a physician. See Instructions for Use 900133-001 for a complete instruction for use and a description of

indications, contraindications, warnings, precautions and adverse events