Association of Type of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement

Study Overview
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Brief Summary
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This study proposes to perform a descriptive analysis and pilot observational study looking at the types and quantity of anesthetic agents used and their associations with outcomes among patients scheduled to receive transfemoral aortic valve replacements (TAVR) at Yale New Haven Hospital (YNHH).

Detailed Description
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This study proposes to perform a descriptive analysis and pilot observational study looking at the types and quantity of anesthetic agents used and their associations with outcomes among patients scheduled to receive TAVR at YNHH. Hypothesis 1: TAVR surgery done under monitored anesthesia care are performed using some combination of the following anesthetics: dexmedetomidine, propofol, fentanyl, and midazolam. Hypothesis 2: Age-adjusted dosing of these agents will be insufficient to account for extreme age after controlling for preoperative comorbid status. Hypothesis 3: The rate of conversion to general anesthesia will be unrelated to the type of conscious sedation used. Hypothesis 4: ICU length of stay, delirium, hospital length of stay, and length of hospital stay will be shorter for patients who were sedated using dexmedetomidine vs those without. Research Plan: The research will be done via chart review and analysis of data already contained in the Multicenter Perioperative Outcomes Group databases at Yale. The possible risks are primarily the risk to privacy that is inherent in any retrospective chart review. The benefit may be to suggest areas of future study to improve sedation practices for TAVR at Yale and elsewhere. Information recorded will include demographic and preoperative medical assessment from prior to the TAVR, the anesthetic record, and the post-operative course of recovery for patients undergoing TAVR. These data will include age, gender, comorbidities, laboratory values, vital signs, and the results of imaging studies as well as other records potentially related to the above hospitalization.

Official Title
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Pilot Analysis of the Association Between Types of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement

Conditions
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Aortic Stenosis

Intervention / Treatment
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* Drug: Dexmedetomidine with propofol
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who underwent TAVR at YNHH under planned conscious sedation with monitored anesthetic care Exclusion Criteria: Patients who received monitored anesthesia care without the receipt of any study intervention drug (propofol, fentanyl, midazolam, or dexmedetomidine).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Propofol-dominant Sedation<br>Patients receiving propofol infusion for TAVR as the primary drug for sedation. | Drug: Propofol<br>* A propofol-dominant anesthetic will be defined as an anesthetic that included a continuous infusion of propofol within 15 minutes of anesthesia start. This definition was subsequently modified to include patients who received propofol infusion but not dexmedetomidine.<br>* Other names: Diprivan;|
| Dexmedetomidine-dominant Sedation<br>Patients receiving dexmedetomidine infusion for TAVR as the primary drug for sedation. | Drug: Dexmedetomidine with propofol<br>* A dexmedetomidine- dominant anesthetic will be defined as an anesthetic that included a continuous infusion of dexmedetomidine within 15 minutes of anesthesia start. This group was subsequently modified in light of retrospective data collection to specify a group receiving dexmedetomidine in combination with propofol.<br>* Other names: Precedex;Drug: Propofol<br>* A propofol-dominant anesthetic will be defined as an anesthetic that included a continuous infusion of propofol within 15 minutes of anesthesia start. This definition was subsequently modified to include patients who received propofol infusion but not dexmedetomidine.<br>* Other names: Diprivan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Length | Procedure length will be collected from retrospective analysis of charts. | During surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU Length of Stay | ICU length of stay will be collected from retrospective analysis of charts. | From the conclusion of surgery until patient leaves the ICU, up to 2 weeks | 
| Rate of Conversion to General Anesthesia | Rate of conversion to general anesthesia will be collected from retrospective analysis of charts. | During surgery | 
| Hospital Length of Stay | Hospital length of stay will be collected via retrospective analysis of charts. | From the conclusion of surgery until patient is discharged, up to 2 weeks | 
| Delirium Incidence | Whether or not the patient experiences delirium during their hospital stay as recorded in their notes by the treating physician. | From the conclusion of surgery until patient is discharged, up to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcatheter aortic valve replacement, anesthesia, conscious sedation, managed anesthesia care