Baroreflex activation device implant (Barostim)

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Baroreflex activation therapy (BAT) Barostim is an advanced device that leverages the principles of baroreflex activation therapy to modulate the autonomic nervous system and treat conditions like resistant hypertension and heart failure with reduced ejection fraction (HFrEF). The device currently implanted by our vascular surgeons is the Barostim Neo2 designed by CVRX. A lead is placed on the carotid sinus via a small cutdown, tunneled under the subcutaneous tissue, and connected to a generator that is placed in the chest and can be controlled by an external programmer. Heart failure with reduced ejection fraction involves disturbances of the autonomic nervous system characterized by decreased baroreceptor sensitivity, increased sympathetic tone, and decreased parasympathetic tone[1]. Baroreflex activation therapy (BAT) aims to restore balance to the autonomic nervous system by increasing parasympathetic output via electrical stimulation of the carotid baroreceptors. In clinical trials BAT has been shown to be safe and significantly improved QOL, exercise capacity, and NT-proBNP[2] in patients with HFrEF. This approach helps mitigate the progression of heart failure by reducing neurohormonal activation.[3][4][5]

Baroreflex activation device implant (Barostim)
Anesthesia type

General

Airway

ETT

Lines and access

PIV x2 +/- Arterial line

Monitors

Standard BIS +/- ABP

Primary anesthetic considerations
Preoperative

Heart failure symptoms

Intraoperative

Avoid baroreflex blunting medications

Postoperative

Standard

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Editor rating
Unrated
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Overview

Indications

  • Barostim is indicated for patients who are NYHA Class III or Class II (who had a recent history of Class III) despite treatment with guideline-directed medical therapies (medications and devices), have a left ventricular ejection fraction of ≤ 35% and a NT-proBNP <1600 pg/ml.[6][7][8][9]
  • Refractory hypertension or inability to tolerate antihypertensive agents
  • Contraindications to LVAD, heart transplant
  • Autonomic Imbalance and Sympathetic Hyperactivity/POTS/Tachycardia

Contraindications

  • Patient eligible for cardiac resynchronization therapy
  • Bilateral carotid bifurcations located above the level of the mandible
  • Baroreflex failure or autonomic neuropathy
  • Uncontrolled, symptomatic cardiac bradyarrhythmias
  • Carotid artery stenosis greater than 50% caused by atherosclerosis, as determined by ultrasound or angiographic evaluation
  • Pregnancy
  • Local or systemic infection
  • Device to device interactions possible (e.g. AICD)[10]

Controversy

Barostim’s cost-effectiveness in refractory hypertension patients is debated and battery replacement costs are a significant economic factor. [11][12]

Surgical procedure

The procedure is well described by Weaver et al[13]

Exposure

The first step in the procedure is exposing the carotid artery.

  • The carotid bifurcation is exposed via a cutdown
    • The right carotid is preferentially used as it has been shown to be more sensitive[14]
Mapping

The next step is to map the carotid sinus by testing the baroreceptor reflex at different areas.

  • The surgeons will stimulate different areas of the carotid sinus with an electrode to test for a decrease in heart rate and/or systolic blood pressure
    • Mapping requires a lot of communication between surgery and anesthesia teams
    • Before the initiation of mapping, a stable baseline heart rate and blood pressure should be established
    • Peak responses in heart rate and pressure generally occur within 30-120 seconds of initiating stimulation
  • Many common anesthetic medications can cause blunting of the baroreceptor reflex
    • Maintenance of anesthesia should be tailored to the patient to safely avoid baroreceptor blunting medications (see intraoperative management)
Anchoring and tunneling

The next step is to anchor the electrode to the point of maximal stimulus and tunnel the lead into the chest wall where it is attached to the generator.

Testing and closure

The next step is to test the lead and generator for adequate function and close the chest wall pocket and cutdown.

Preoperative management

Patient evaluation

System Considerations
Cardiovascular Only patients with significant heart failure history undergo BAT. They should be assessed for evidence of volume overload or current heart failure exacerbation. All patients will likely be on a beta blocker and should take it perioperatively
Pulmonary SOB may be evidence of worsening heart failure or exacerbation. Patients with baseline orthopnea may require different positioning prior to induction
Hematologic Likely anemic. Given proximity to great vessels, an active type and screen is recommended
Renal HFrEF patients may have concomitant CKD
Endocrine HFrEF patients may have concomitant diabetes

Labs and studies

  • Type and Screen
  • +/- TTE, TEE, EKG, Stress test

Operating room setup

  • Arterial catheter and transducer
  • Infusion and syringe pumps
  • Vasopressor infusions available
  • Push dose pressors drawn up

Patient preparation and premedication

  • Cardiovascular medications are stopped 4-6 hours before surgery with the exception of beta-blocker therapy, which is down-titrated 1-2 days in advance to a level at which intraoperative bradycardia is not expected to interfere with observation of the baroreflex response
  • If the patient is on DAPT or other anticoagulants they are held for the appropriate time given the indication and risk, as guided by discussion between surgeon and cardiologist
  • Likely a lower than normal threshold for benzodiazepine use in elderly patients as the sedative hypnotics options are limited by baroreceptor reflex concerns

Regional and neuraxial techniques

  • Regional anesthesia is NOT recommended in BAT implantation cases due to concerns for local anesthetic blunting of the baroreceptor reflex

Intraoperative management

Monitoring and access

  • PIV x2
  • Standard monitors
  • BIS
  • +/- Arterial line

Induction and airway management

  • Standard induction for heart failure patient, ETT

Positioning

  • Supine
  • Arms usually tucked

Maintenance and surgical considerations

  • Many of the medications routinely used for maintenance of general anesthesia modulate the baroreceptor reflex; including propofol[15], volatile anesthetics (in a dose dependent fashion)[16], ketamine (in rabbits)[17], and dexmedetomidine[18]
    • Importantly, opioids[19], benzodiazepines[20], etomidate[21], and nitrous oxide[22] all minimally affect the baroreceptor reflex
  • Initial protocols for BAT device implantation recommend avoiding any of the blunting agents: Etomidate induction, benzodiazepine, opioid (as a bolus or infusion), and paralytic maintenance
    • These protocols are based on the theoretical benefit. There is no published data on the success or failure of baroreflex mapping with different regimens [source needed]. The device manufacturers also make suggestions, however, there are no sure recommendations
  • BAT devices have been successfully implanted with different regimens. Safely achieving amnesia and immobility, while avoiding baroreflex blunting is the goal
    • Propofol is a reasonable choice for induction. While it does blunt the reflex, if used only for induction, the blunting effect dissipates in ~10 minutes - usually plenty of time to allow for draping, timeouts, and cutdown
    • Volatile anesthetics below 0.5 MAC limit blunting, are titratable, and allow for a more efficient emergence and recovery
    • Supplement with a remifentanil infusion, fentanyl boluses, or nitrous oxide to ensure adequate depth of anesthesia. Use BIS to help titrate medications
    • Avoid blunting agents which convey little benefit to efficiency and safety of the anesthetic (i.e., ketamine, dexmedetomidine)
    • Each strategy will of course have its drawbacks. A pure benzo-opioid regimen in a frail, elderly patient could necessitate a long recovery phase and increase the potential for delirium while using some of the blunting agents may require changing strategies mid-operation and/or risk failure
  • During the mapping phase the goal is a stable dose of anesthetic, so that changes in HR and SBP can be attributed to sinus stimulation and not changes in medications. You will have transient bradycardia and hypotension during mapping. Be patient, but be prepared to intervene if the patient does not recover after stimulation ceases

Emergence

  • Standard

Postoperative management

Disposition

  • PACU barring complications

Pain management

  • Mild pain procedure, low dose opioids generally sufficient

Potential complications

  • Local discomfort at the implantation site (most common)[23]
  • Bradycardia, hypotension intraoperatively/postoperatively[24]
  • Other arrythmias[25]
  • Pneumothorax (during tunneling or pouch creation)
  • Bleeding, hematoma
  • Hypertensive Crisis[26]
  • Infection
  • Lead displacement
  • Nerve injury
  • Stroke if combined with carotid surgery[27]
  • Safe with concurrent use of AICD[28]
  • In patients with ESRD, parasthesias and dysphagia reported[29]

References

  1. ↑ John S. Floras, Sympathetic Nervous System Activation in Human Heart Failure: Clinical Implications of an Updated Model, Journal of the American College of Cardiology, Volume 54, Issue 5, 2009, Pages 375-385, ISSN 0735-1097, https://doi.org/10.1016/j.jacc.2009.03.061.
  2. ↑ Zile MR, Lindenfeld J, Weaver FA, Zannad F, Galle E, Rogers T, Abraham WT. Baroreflex Activation Therapy in Patients With Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. 2020 Jul 7;76(1):1-13. doi: 10.1016/j.jacc.2020.05.015. PMID: 32616150.
  3. ↑ Zucker, Irving H.; Hackley, Johnnie F.; Cornish, Kurtis G.; Hiser, Bradley A.; Anderson, Nicholas R.; Kieval, Robert; Irwin, Eric D.; Serdar, David J.; Peuler, Jacob D.; Rossing, Martin A. (2007-11). "Chronic Baroreceptor Activation Enhances Survival in Dogs With Pacing-Induced Heart Failure". Hypertension. 50 (5): 904–910. doi:10.1161/HYPERTENSIONAHA.107.095216. ISSN 0194-911X. Check date values in: |date= (help)
  4. ↑ Zile, Michael R.; Abraham, William T.; Weaver, Fred A.; Butter, Christian; Ducharme, Anique; Halbach, Marcel; Klug, Didier; Lovett, Eric G.; Müller‐Ehmsen, Jochen; Schafer, Jill E.; Senni, Michele (2015-10). "Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction: safety and efficacy in patients with and without cardiac resynchronization therapy". European Journal of Heart Failure. 17 (10): 1066–1074. doi:10.1002/ejhf.299. ISSN 1388-9842. Check date values in: |date= (help)
  5. ↑ Abraham, William T.; Zile, Michael R.; Weaver, Fred A.; Butter, Christian; Ducharme, Anique; Halbach, Marcel; Klug, Didier; Lovett, Eric G.; Müller-Ehmsen, Jochen; Schafer, Jill E.; Senni, Michele (2015-06). "Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction". JACC: Heart Failure. 3 (6): 487–496. doi:10.1016/j.jchf.2015.02.006. Check date values in: |date= (help)
  6. ↑ Zile, Michael R.; Lindenfeld, JoAnn; Weaver, Fred A.; Zannad, Faiez; Galle, Elizabeth; Rogers, Tyson; Abraham, William T. (2020-07). "Baroreflex Activation Therapy in Patients With Heart Failure With Reduced Ejection Fraction". Journal of the American College of Cardiology. 76 (1): 1–13. doi:10.1016/j.jacc.2020.05.015. Check date values in: |date= (help)
  7. ↑ Coats, Andrew J.S.; Abraham, William T.; Zile, Michael R.; Lindenfeld, Joann A.; Weaver, Fred A.; Fudim, Marat; Bauersachs, Johann; Duval, Sue; Galle, Elizabeth; Zannad, Faiez (2022-09). "Baroreflex activation therapy with the Barostim ™ device in patients with heart failure with reduced ejection fraction: a patient level meta‐analysis of randomized controlled trials". European Journal of Heart Failure. 24 (9): 1665–1673. doi:10.1002/ejhf.2573. ISSN 1388-9842. PMC PMC9796660 Check |pmc= value (help). PMID 35713888 Check |pmid= value (help). Check date values in: |date= (help)CS1 maint: PMC format (link)
  8. ↑ Heidenreich, Paul A.; Bozkurt, Biykem; Aguilar, David; Allen, Larry A.; Byun, Joni J.; Colvin, Monica M.; Deswal, Anita; Drazner, Mark H.; Dunlay, Shannon M.; Evers, Linda R.; Fang, James C. (2022-05-03). "2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines". Circulation. 145 (18). doi:10.1161/CIR.0000000000001063. ISSN 0009-7322.
  9. ↑ Heidenreich, Paul A.; Bozkurt, Biykem; Aguilar, David; Allen, Larry A.; Byun, Joni J.; Colvin, Monica M.; Deswal, Anita; Drazner, Mark H.; Dunlay, Shannon M.; Evers, Linda R.; Fang, James C. (2022-05). "2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure". Journal of the American College of Cardiology. 79 (17): e263–e421. doi:10.1016/j.jacc.2021.12.012. Check date values in: |date= (help)
  10. ↑ Weipert, Kay F.; Andrick, Jens; Chasan, Ritvan; Gemein, Christopher; Most, Astrid; Hamm, Christian W.; Erkapic, Damir; Schmitt, Joern (2018-01). "Baroreceptor stimulation in a patient with preexisting subcutaneous implantable cardioverter defibrillator". Pacing and Clinical Electrophysiology. 41 (1): 90–92. doi:10.1111/pace.13115. ISSN 0147-8389. Check date values in: |date= (help)
  11. ↑ Soto, Marcelo; Sampietro-Colom, Laura; Sagarra, Joan; Brugada-Terradellas, Josep (2016-06). "InnovaSEC in Action: Cost-effectiveness of Barostim in the Treatment of Refractory Hypertension in Spain". Revista Espanola De Cardiologia (English Ed.). 69 (6): 563–571. doi:10.1016/j.rec.2015.11.027. ISSN 1885-5857. PMID 26907729. Check date values in: |date= (help)
  12. ↑ Borisenko, Oleg; Beige, Joachim; Lovett, Eric G.; Hoppe, Uta C.; Bjessmo, Staffan (2014-03). "Cost-effectiveness of Barostim therapy for the treatment of resistant hypertension in European settings". Journal of Hypertension. 32 (3): 681–692. doi:10.1097/HJH.0000000000000071. ISSN 0263-6352. Check date values in: |date= (help)
  13. ↑ Weaver FA, Abraham WT, Little WC, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Madershahian N, Müller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Zile MR. Surgical Experience and Long-term Results of Baroreflex Activation Therapy for Heart Failure With Reduced Ejection Fraction. Semin Thorac Cardiovasc Surg. 2016 Summer;28(2):320-328. doi: 10.1053/j.semtcvs.2016.04.017. Epub 2016 Jun 2. PMID: 28043438.
  14. ↑ de Leeuw PW, Alnima T, Lovett E, Sica D, Bisognano J, Haller H, Kroon AA. Bilateral or unilateral stimulation for baroreflex activation therapy. Hypertension. 2015 Jan;65(1):187-92. doi: 10.1161/HYPERTENSIONAHA.114.04492. Epub 2014 Oct 20. PMID: 25331845.
  15. ↑ Sato M, Tanaka M, Umehara S, Nishikawa T. Baroreflex control of heart rate during and after propofol infusion in humans. Br J Anaesth. 2005 May;94(5):577-81. doi: 10.1093/bja/aei092. Epub 2005 Feb 18. PMID: 15722386.
  16. ↑ Ebert, Thomas J. MD, PhD;  Harkin, Christopher P. MD;  Muzi, Michael MD. Cardiovascular Responses to Sevoflurane: A Review. Anesthesia & Analgesia 81(6S):p 11S-22S, December 1995.
  17. ↑ Van Leeuwen AF, Evans RG, Ludbrook J. Effects of halothane, ketamine, propofol and alfentanil anaesthesia on circulatory control in rabbits. Clin Exp Pharmacol Physiol. 1990 Nov;17(11):781-98. doi: 10.1111/j.1440-1681.1990.tb01280.x. PMID: 2078906.
  18. ↑ Ebert TJ, Hall JE, Barney JA, Uhrich TD, Colinco MD. The effects of increasing plasma concentrations of dexmedetomidine in humans. Anesthesiology. 2000 Aug;93(2):382-94. doi: 10.1097/00000542-200008000-00016. PMID: 10910487.
  19. ↑ Kotrly KJ, Ebert TJ, Vucins EJ, Roerig DL, Stadnicka A, Kampine JP. Effects of fentanyl-diazepam-nitrous oxide anaesthesia on arterial baroreflex control of heart rate in man. Br J Anaesth. 1986 Apr;58(4):406-14. doi: 10.1093/bja/58.4.406. PMID: 3954921.
  20. ↑ Win NN, Kohase H, Yoshikawa F, Wakita R, Takahashi M, Kondo N, Ushito D, Umino M. Haemodynamic changes and heart rate variability during midazolam-propofol co-induction. Anaesthesia. 2007 Jun;62(6):561-8. doi: 10.1111/j.1365-2044.2007.04990.x. PMID: 17506733.
  21. ↑ Ebert TJ, Muzi M, Berens R, Goff D, Kampine JP. Sympathetic responses to induction of anesthesia in humans with propofol or etomidate. Anesthesiology. 1992 May;76(5):725-33. doi: 10.1097/00000542-199205000-00010. PMID: 1575340.
  22. ↑ Tanaka, M., and T. Nishikawa. "Effects of nitrous oxide on baroreflex gain and heart rate variability." Acta anaesthesiologica scandinavica 48.9 (2004): 1163-1167.
  23. ↑ Wallbach, Manuel; Böhning, Enrico; Lehnig, Luca-Yves; Schroer, Charlotte; Müller, Gerhard Anton; Wachter, Rolf; Lüders, Stephan; Zenker, Dieter; Koziolek, Michael Johann (2018-08). "Safety profile of baroreflex activation therapy (NEO) in patients with resistant hypertension". Journal of Hypertension. 36 (8): 1762–1769. doi:10.1097/HJH.0000000000001753. ISSN 0263-6352. Check date values in: |date= (help)
  24. ↑ Wallbach, Manuel; Böhning, Enrico; Lehnig, Luca-Yves; Schroer, Charlotte; Müller, Gerhard Anton; Wachter, Rolf; Lüders, Stephan; Zenker, Dieter; Koziolek, Michael Johann (2018-08). "Safety profile of baroreflex activation therapy (NEO) in patients with resistant hypertension". Journal of Hypertension. 36 (8): 1762–1769. doi:10.1097/HJH.0000000000001753. ISSN 0263-6352. Check date values in: |date= (help)
  25. ↑ Wallbach, Manuel; Böhning, Enrico; Lehnig, Luca-Yves; Schroer, Charlotte; Müller, Gerhard Anton; Wachter, Rolf; Lüders, Stephan; Zenker, Dieter; Koziolek, Michael Johann (2018-08). "Safety profile of baroreflex activation therapy (NEO) in patients with resistant hypertension". Journal of Hypertension. 36 (8): 1762–1769. doi:10.1097/HJH.0000000000001753. ISSN 0263-6352. Check date values in: |date= (help)
  26. ↑ Wallbach, Manuel; Böhning, Enrico; Lehnig, Luca-Yves; Schroer, Charlotte; Müller, Gerhard Anton; Wachter, Rolf; Lüders, Stephan; Zenker, Dieter; Koziolek, Michael Johann (2018-08). "Safety profile of baroreflex activation therapy (NEO) in patients with resistant hypertension". Journal of Hypertension. 36 (8): 1762–1769. doi:10.1097/HJH.0000000000001753. ISSN 0263-6352. Check date values in: |date= (help)
  27. ↑ Weipert, Kay F.; Most, Astrid; Doerr, Oliver; Koshty, Ahmed; Hamm, Christian W.; Erkapic, Damir; Schmitt, Joern (2016-10). "Barostim Implantation with Ipsilateral Carotid Endarterectomy as a One-Stage Procedure". Annals of Vascular Surgery. 36: 295.e9–295.e11. doi:10.1016/j.avsg.2016.03.026. ISSN 1615-5947. PMID 27423727. Check date values in: |date= (help)
  28. ↑ Weipert, Kay F.; Andrick, Jens; Chasan, Ritvan; Gemein, Christopher; Most, Astrid; Hamm, Christian W.; Erkapic, Damir; Schmitt, Joern (2018-01). "Baroreceptor stimulation in a patient with preexisting subcutaneous implantable cardioverter defibrillator". Pacing and clinical electrophysiology: PACE. 41 (1): 90–92. doi:10.1111/pace.13115. ISSN 1540-8159. PMID 28543399. Check date values in: |date= (help)
  29. ↑ Beige, Joachim; Koziolek, Michael J.; Hennig, Gert; Hamza, Amir; Wendt, Ralph; Müller, Gerhard A.; Wallbach, Manuel (2015-11). "Baroreflex activation therapy in patients with end-stage renal failure: proof of concept". Journal of Hypertension. 33 (11): 2344–2349. doi:10.1097/HJH.0000000000000697. ISSN 0263-6352. Check date values in: |date= (help)

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