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MAC for TAVR: Eyes Wide OpenManoj Iyer, MDMay 19, 2017

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No Conflicts of Interest

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Objectives

• Review the literature of TAVRs performed under MAC/sedation vsGeneral Anesthesia

• Discuss possible complications of TAVRs done under sedation and risk factors for conversion from sedation to general anesthesia

• Discuss potential cost (monetary, time and outcomes) savings for cases done under sedation versus general anesthesia

Transcatheter Aortic Valve Replacement

• >200,000 TAVRs have been performed worldwide

• First performed April 16, 2002 in Paris1

‒ 16 years of evolution has lead to this becoming an everyday procedure

• Revolutionized treatment of severe aortic stenosis when patients were considered non-operable

• FDA has recently approved for intermediate-risk patients

• Studies looking at TAVR for low risk patients4

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Overview of Procedure

• Newest generation valve systems‒ Sapien 3 (Edwards Lifescience)‒ CoreValve Evolut-R (Medtronic)

• Retrograde transfemoral approach‒ Other options include subclavian/axillary, transaortic,

transapical, transcaval and even transcarotid

• Differences‒ Sapien is balloon-expandable

• Requires rapid ventricular pacing to prevent migration or ejection of valve

‒ CoreValve is self-expanding‒ CoreValve can be recaptured and repositioned if

necessary

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General (GA) versus Monitored Anesthesia Care (MAC)

• First TAVR performed with local anesthesia and minimal sedation

• Early stage of development of TAVR saw almost uniform use of GA‒ still most common type of anesthesia today5

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Choice of Anesthesia—the tides are changing

• Bufton et al. (2013)6

‒ North America (95%) GA‒ Europe (30%) GA

• Giri et al. (2016)‒ MAC increased from 10 to almost 30%

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Anesthetic Considerations

• Monitoring/IV access‒ Arterial line‒ Echocardiography‒ Fluoroscopy‒ IV access

• Procedure‒ Supine position‒ Duration‒ Access‒ Need for pacing‒ Emergency surgical conversion

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Advantages of General

• More control of procedural environment with secure airway and completely immobile patient

• Can allow for apneic periods to allow for precise valve deployment

• Gives cardiologist unlimited time to complete procedure via any access point

• Allows use of TEE for quick assessment of valve deployment

• Allows for quick conversion to sAVR if needed

• Early stages of TAVR necessitated GA‒ Higher complications rates‒ Duration of procedure was longer

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Disadvantages of General Anesthesia

• Pneumonia‒ Prolonged intubation

• Hemodynamic compromise‒ Need for maintenance of SVR and vasopressors

• Increased length of stay/ICU stay‒ Increased mortality‒ Increased hospital acquired infections

• Risk of mortality 0.03 per 1000 patients

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Evolution of MAC

• Technological advancements

• Better operator experiences

• Standardized protocols

• Lower profile delivery systems

• Less paravalvular regurgitation

• GA still required for most non-transfemoral approaches, high risk patients, and when TEE guidance is needed

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MAC

• Used almost exclusively at most high-volume centers7,8

• Depends on amenable percutaneous transfemoralapproach

• TTE if necessary

• Reduction or elimination of balloon valvuloplasty

• Clearly defined post-op plans

• Hurdles:‒ No standardization for sedations‒ Tight rope between sedation and “disinhibited” state‒ Patient consent

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Benefits of MAC

• Less hemodynamic instability

• Avoidance of intubation and mechanical ventilation

• Faster postop recovery

• Ability to monitor of CNS embolic events

• With newer valve design, paravalvular regurgitation has decreased significantly‒ No need for immediate post implant echo imagining‒ Less need for echocardiography staff and physicians

• Lower risk of postoperative delirium

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Postoperative delirium

• Patient population for TAVR is at unique risk for developing postop delirium‒ Advanced age, frailty, significant comorbidities

• Abawi et al9

‒ Retrospective study‒ Delirium more frequent in non-transfemoral approaches

(50% vs 10%)• Confounded that all non-transfemoral approaches

performed under GA—cannot determine if independent from type of anesthesia

• Severe vascular disease—leads to nontransfemoralapproach—higher risk of cerebral emboli and ischemia‒ Leads to longer ICU/hospital stay

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MAC anesthesia

• Previous studies have not shown a difference in short or intermediate-term survival between GA and MAC

• More recent data shows MAC may be associated with better outcomes

• Largest study thus far (Giri et al5):‒ 10,997 patients 4/14-6/15‒ MAC patients had significantly lower 30 day mortality

(2.9% vs 4.1%), lower composite mortality and/or stroke rate (4.8% vs 6.4%), shorter hospital stay (6d vs 7d)

‒ Despite propensity matching, may have bias due to non-transfemoral patients having more comorbidities

• 4/14-6/15‒ Number of programs using MAC went from 10% up to

almost 30%

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Risks of MAC

• Need to be prepared for contingencies

• Need for general anesthesia promptly

• Hypoxia and hypercarbia‒ Pulmonary aspiration

• Rate of conversion is about 2%, but can be as high as 5-6%5

‒ Usually due to annular rupture or cardiac perforation‒ Embolization of TAVR in to the LV‒ Patient intolerance of laying still

• Goals of care need to be discussed prior to proceeding

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Intraprocedural Anesthesia characteristics

• Average procedural time 137 +/- 32 minutes‒ GA significantly longer 146+/- 34 mins vs 132 +/- 30 mins

• Complications‒ More pulmonary complications in GA group, but not

statistically significant‒ Higher incidence of sepsis in GA group‒ Patients in GA group more likely to receive blood‒ Overall hospital stay was similar‒ 4.7% converted to GA

• Hypotension was the main problem with failed sedations

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Summary

• TAVR has revolutionized care of patients with severe aortic stenosis

• A superior treatment alternative to sAVR in patients that are at high risk

• MAC shows similar procedural success as GA, but has improved patient safety outcomes

• Anesthesia provider must always be prepared—along with proceduralist teams

• As TAVR moves to low risk candidates, the importance of readiness becomes more relevant

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References

• 1. Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation 2002; 106:3006-8.

• 2. Vahl TP, Kodali SK, Leon MB. Transcatheter aortic valve replacement 2016: a modern-day “through the looking-glass” adventure. J Am Coll Cardiol2016; 67: 1472-1487.

• 3. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2014; 63:e57-e185.

• 4. The safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve in low risk patients with aortic stenosis (Partner 3). https://clinicaltrials.gov/ct2/show/NCT02675114

• 5. Giri, J. Moderate sedation vs. general anesthesia for transcatheter aortic valve replacement: An STS/ACC Transcatheter Valve Therapy Registry analysis. SCAI Annual Meeting, May 2016.

• 6. Bufton KA, Augoustides JA, et al. Anesthesia for transfemoral aortic valve replacement in North American and Europe. J Cardiovasc Thoracic Anesth. 2013;26:46-49.

• 7. Motloch LJ, Rottlaender D, Reda S, et al. Local versus general anesthesia for transfemoral aortic valve implantation. Clin Res Cardiol 2012; 101:45-53.

• 8. Kasel AM, Shivaraju A, Schneider S, et al. Standardized methodology for transfemoral transcatheter aortic valve replacement with the Edwards Sapien XT valve under fluoroscopy guidance. J Invasive Cardiol 2014; 26: 451-461.

• 9. Abawi M, Nijhoff F, Agostino P, et al. Incidence, predictive factors, and effect of delirium after transcatheter aortic valve replacement. JACC Cardiovasc Interv 2016; 25;9:160-8.

• Maniar HS, Lindman BR, et al. Delirium after surgical and transcatheter aortic valve replacement is associated with increased mortality. J ThoracCardiovasc Surg 2016;151:815-23.

• Kiramijyan S, Ben-Dor I, Koifman E, Didier R, Magalhaes MA, Escarcega RA, Negi SI, Baker NC, Gai J, Torguson R, Okubabzi P, Asch FM, Wang Z, Gaglia MA Jr, Satler LF, Pichard AD, Waksman R. Comparison of clinical outcomes with the utilization of monitored anesthesia care vs. general anesthesia in patients undergoing transcatheter aortic valve replacement. Cardiovasc Revasc Med. 2016 Sep; 17(6):384-90.

• Goren O, Finkelstein A, Gluch A, Sheinberg N, Dery E, Matot I. Sedation or general anesthesia for patients undergoing transcatheter aortic valve implantation—does it affect outcome? An observational single-center study. J Clin Anesth. 2015 Aug; 27(5):385-90

• Jabbar A, Khurana A, Mohammed A, Das R, Zaman A, Edwards R. Local Versus General Anesthesia in Transcatheter Aortic Valve Replacement. Am J Cardiol. 2016 Dec 1; 118(11):1712-1716.

• Brecker SJ, Bleiziffer S, Vosmans J, Gerckens U, Tamburino C, Wenaweser P, Linke A; ADVANCE Study Investigators. Impact of Anesthesia Type on Outcomes of Transcatheter Aortic Valve Implantation (from the Multicenter ADVANCE Study). Am J Cardiol. 2016 Apr 15;117(8): 1332-8.

• Novak, TE and Parulkar S. The Anesthesia Professional’s Role in Patient Safety During TAVR (Transcatheter Aortic Valve Replacement). ASPF Newsletter 2017 Feb Vol 31, No. 3 73-75.

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