Aortic Stenosis
Conditions
Keywords
transcatheter aortic valve replacement, anesthesia, conscious sedation, managed anesthesia care
Brief summary
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
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.
Interventions
DRUGDexmedetomidine with propofol
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.
DRUGPropofol
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.
Sponsors
Yale University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Length | During surgery | Procedure length will be collected from retrospective analysis of charts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU Length of Stay | From the conclusion of surgery until patient leaves the ICU, up to 2 weeks | ICU length of stay will be collected from retrospective analysis of charts. |
| Rate of Conversion to General Anesthesia | During surgery | Rate of conversion to general anesthesia will be collected from retrospective analysis of charts. |
| Hospital Length of Stay | From the conclusion of surgery until patient is discharged, up to 2 weeks | Hospital length of stay will be collected via retrospective analysis of charts. |
| Delirium Incidence | From the conclusion of surgery until patient is discharged, up to 2 weeks | Whether or not the patient experiences delirium during their hospital stay as recorded in their notes by the treating physician. |
Participant flow
Recruitment details
This study was a retrospective chart review and did not include prospective enrollment. As noted in the pre-assignment details, the number of enrolled participants was determined by chart review.
Pre-assignment details
As specified above, this study was a retrospective chart review and thus enrollment was determined by existence of charts rather than by prospective enrollment. While patients were screened for other modes of sedation, data were only collected on the two groups included presently.
Participants by arm
| Arm | Count |
|---|---|
| Propofol and Dexmedetomidine Defined as any MAC that included both propofol and dexmedetomidine and may have included fentanyl, remifentanil, or midazolam | 34 |
| Propofol Only Defined as any MAC that included propofol infusions or injections in the absence of dexmedetomidine. These patients also may have received injections of fentanyl, remifentanil, or midazolam. | 39 |
| Total | 73 |
Baseline characteristics
| Characteristic | Propofol Only | Total | Propofol and Dexmedetomidine |
|---|---|---|---|
| Age, Continuous | 87 years | 87 years | 84 years |
| Alcoholism No | 38 Participants | 72 Participants | 34 Participants |
| Alcoholism Yes | 1 Participants | 1 Participants | 0 Participants |
| American Society of Anesthesiologists (ASA) Physical Status Score 3 | 3 Participants | 8 Participants | 5 Participants |
| American Society of Anesthesiologists (ASA) Physical Status Score 4 | 36 Participants | 65 Participants | 29 Participants |
| Anxiety disorder No | 35 Participants | 65 Participants | 30 Participants |
| Anxiety disorder Yes | 4 Participants | 8 Participants | 4 Participants |
| Atrial fibrillation No | 18 Participants | 40 Participants | 22 Participants |
| Atrial fibrillation Yes | 21 Participants | 33 Participants | 12 Participants |
| Body Mass Index (BMI) | 29.2 kg/m^2 | 26.7 kg/m^2 | 25.6 kg/m^2 |
| Cerebrovascular disease No | 38 Participants | 67 Participants | 29 Participants |
| Cerebrovascular disease Yes | 1 Participants | 6 Participants | 5 Participants |
| Congestive Heart Failure (CHF) No | 17 Participants | 32 Participants | 15 Participants |
| Congestive Heart Failure (CHF) Yes | 22 Participants | 41 Participants | 19 Participants |
| Coronary Artery Disease (CAD) No | 13 Participants | 25 Participants | 12 Participants |
| Coronary Artery Disease (CAD) Yes | 26 Participants | 48 Participants | 22 Participants |
| Depression No | 35 Participants | 65 Participants | 30 Participants |
| Depression Yes | 4 Participants | 8 Participants | 4 Participants |
| Diabetes No | 27 Participants | 51 Participants | 24 Participants |
| Diabetes Yes | 12 Participants | 22 Participants | 10 Participants |
| Height | 1.6 meters | 1.6 meters | 1.6 meters |
| Hypertension No | 5 Participants | 9 Participants | 4 Participants |
| Hypertension Yes | 34 Participants | 64 Participants | 30 Participants |
| Left ventricular ejection fraction (LVEF) | 62 % | 62 % | 63 % |
| New York Heart Association Congestive Heart Failure (NYHA CHF)HF classification 2 | 1 Participants | 6 Participants | 5 Participants |
| New York Heart Association Congestive Heart Failure (NYHA CHF)HF classification 3 | 32 Participants | 56 Participants | 24 Participants |
| New York Heart Association Congestive Heart Failure (NYHA CHF)HF classification 4 | 6 Participants | 11 Participants | 5 Participants |
| Obstructive sleep apnea No | 33 Participants | 65 Participants | 32 Participants |
| Obstructive sleep apnea Yes | 6 Participants | 8 Participants | 2 Participants |
| Peripheral vascular disease No | 35 Participants | 62 Participants | 27 Participants |
| Peripheral vascular disease Yes | 4 Participants | 11 Participants | 7 Participants |
| Psychosis No | 39 Participants | 73 Participants | 34 Participants |
| Psychosis Yes | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized White/Caucasian | 34 Participants | 65 Participants | 31 Participants |
| Renal disease No | 30 Participants | 52 Participants | 22 Participants |
| Renal disease Yes | 9 Participants | 21 Participants | 12 Participants |
| Sex: Female, Male Female | 15 Participants | 35 Participants | 20 Participants |
| Sex: Female, Male Male | 24 Participants | 38 Participants | 14 Participants |
| Substance abuse No | 39 Participants | 73 Participants | 34 Participants |
| Substance abuse Yes | 0 Participants | 0 Participants | 0 Participants |
| Weight | 76.6 kg | 73.7 kg | 71.5 kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Procedure Length
Procedure length will be collected from retrospective analysis of charts.
Time frame: During surgery
Population: NB: The analyzed groups are the subset of the participant arms that were deemed to have sufficient numbers for comparison. Other groups were excluded from analysis after descriptive understanding of the makeup of this retrospective cohort.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Propofol and Dexmedetomidine | Procedure Length | 114.5 minutes |
| Propofol Only | Procedure Length | 100 minutes |
Secondary
Delirium Incidence
Whether or not the patient experiences delirium during their hospital stay as recorded in their notes by the treating physician.
Time frame: From the conclusion of surgery until patient is discharged, up to 2 weeks
Population: NB: The analyzed groups are the subset of the participant arms that were deemed to have sufficient numbers for comparison. Other groups were excluded from analysis after descriptive understanding of the makeup of this retrospective cohort.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Propofol and Dexmedetomidine | Delirium Incidence | No | 34 Participants |
| Propofol and Dexmedetomidine | Delirium Incidence | Yes | 0 Participants |
| Propofol Only | Delirium Incidence | No | 38 Participants |
| Propofol Only | Delirium Incidence | Yes | 1 Participants |
Secondary
Hospital Length of Stay
Hospital length of stay will be collected via retrospective analysis of charts.
Time frame: From the conclusion of surgery until patient is discharged, up to 2 weeks
Population: NB: The analyzed groups are the subset of the participant arms that were deemed to have sufficient numbers for comparison. Other groups were excluded from analysis after descriptive understanding of the makeup of this retrospective cohort.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Propofol and Dexmedetomidine | Hospital Length of Stay | 2 days |
| Propofol Only | Hospital Length of Stay | 2 days |
Secondary
ICU Length of Stay
ICU length of stay will be collected from retrospective analysis of charts.
Time frame: From the conclusion of surgery until patient leaves the ICU, up to 2 weeks
Population: NB: The analyzed groups are the subset of the participant arms that were deemed to have sufficient numbers for comparison. Other groups were excluded from analysis after descriptive understanding of the makeup of this retrospective cohort.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Propofol and Dexmedetomidine | ICU Length of Stay | 1 days |
| Propofol Only | ICU Length of Stay | 1 days |
Secondary
Rate of Conversion to General Anesthesia
Rate of conversion to general anesthesia will be collected from retrospective analysis of charts.
Time frame: During surgery
Population: NB: The analyzed groups are the subset of the participant arms that were deemed to have sufficient numbers for comparison. Other groups were excluded from analysis after descriptive understanding of the makeup of this retrospective cohort.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Propofol and Dexmedetomidine | Rate of Conversion to General Anesthesia | No | 31 Participants |
| Propofol and Dexmedetomidine | Rate of Conversion to General Anesthesia | Yes | 3 Participants |
| Propofol Only | Rate of Conversion to General Anesthesia | No | 38 Participants |
| Propofol Only | Rate of Conversion to General Anesthesia | Yes | 1 Participants |