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| Name | Class |
|---|---|
| Henry Ford Hospital | OTHER |
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Implementation of Physical Therapy (PT) and Occupational Therapy (OT) pathway (initiation of services on Post procedure day #1 and continued daily with focus on education and activity progression) for all patients undergoing a transcatheter aortic value repair procedure began on December 2, 2014. Retrospective data was collected from The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Aortic Valve Replacement Procedures (STS/ACC TVT, trademark) Registry - National database for Transcatherter Aortic Valve Replacement Procedures and included subjects from March 2012 through July 31, 2015. Patients included: s/p tAVR via transfemoral catheter approach, with or without minor intra or post procedure events (GI bleeds, minor access bleeds, afib, etc); Exclusions: Major events including stroke, pacemaker placement, other cardiovascular (CV) repair or surgery required, etc). Future data analysis will extend subjects to December 31, 2015 and annually.
Rationale: Frequency of transcatheter and other structural heart procedures increased dramatically from 2012 to 2014 and is trending even higher for 2015. Procedures increased from 15 in 2012 to 50 cases in 2013 (233% increase) and to 70 cases in 2014 (40% increase from 2013 to 2014.) -- PT and OT identified a gap in consults and need for specific education targeted for a new surgery population (tAVR) without sternotomy. Often consults were placed on day of discharge to rehab facility or not at all. -- Structural Heart division of CV institute identified increased length of stay (LOS) and decreased activity of their patients in the hospital. -- No literature on this subject found via Henry Ford Hospital Sladen Library PubMed literature review
Aim: • Create a standardized pathway for new transcatheter aortic valve replacement patients in the Structural Heart Division (SHD)
Implementation:
Intervention: • Added PT and OT to Structural Heart Order Set.
Outcome measures: Hospital Length of stay, discharge disposition. Data Analysis: Chi-square tests are used to compare proportions between groups, while Wilcoxon two-sample tests are used to compare distributions of continuous variables between groups. This nonparametric test was chosen due to non-Gaussian distribution of the continuous outcomes within groups. Statistical significance was set at p<0.05. All analyses were performed using SAS 9.4 (SAS Institute Inc, Cary, North Carolina, USA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post procedure routine PT and or OT | Routine PT and or OT |
| |
| Post Procedure PT and OT pathway | Post procedure day zero nursing mobilization; post procedure day one PT and OT assessment and intervention, daily PT and OT intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Post procedure daily PT and OT | Other | PT evaluation and treatment on post procedure day zero: Nurses mobility patient using egress testing one time |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post Procedure Hospital Length of Stay | From date of procedure until date of hospital discharge, assessed up to 50 days. | at discharge |
| Total Hospital Length of Stay | Days from Hospital admission to Hospital Discharge | at discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Discharge Disposition, Home | Discharge destination at discharge. Home includes those discharge home, Home with assistance or Home with Home care. | on day of hospital discharge |
| Discharge Destination, Rehab Facility |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive population sample of patients at Henry Ford Hospital, Detroit, Michigan undergoing transcatheter aortic valve replacement via femoral access in cath lab from March 2012 to present.
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| Name | Affiliation | Role |
|---|---|---|
| Adele Myszenski, MPT | Henry Ford Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25086843 | Background | Babaliaros V, Devireddy C, Lerakis S, Leonardi R, Iturra SA, Mavromatis K, Leshnower BG, Guyton RA, Kanitkar M, Keegan P, Simone A, Stewart JP, Ghasemzadeh N, Block P, Thourani VH. Comparison of transfemoral transcatheter aortic valve replacement performed in the catheterization laboratory (minimalist approach) versus hybrid operating room (standard approach): outcomes and cost analysis. JACC Cardiovasc Interv. 2014 Aug;7(8):898-904. doi: 10.1016/j.jcin.2014.04.005. Epub 2014 Jul 30. | |
| 25413312 |
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IRB was closed March 08-2021 and no plans to share data from this preliminary study
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Patients excluded from database included those with an access sites other than femoral, the occurrence of major events including death, stroke, myocardial infarction (MI), additional cardiac or vascular surgery, electrophysiological monitoring, pacemaker placement, atrial fibrillation, other car-diovascular repair or surgery required, gastrointestinal bleeds, hematoma or access bleeds, or complications
Retrospective study of patients whom received a tAVR procedure via transfemoral catheter percutaneous access site in the catheterization laboratory at HFH from March 1, 2012, to December 31, 2015. Exclusion criteria included access sites other than femoral, the occurrence of major events.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group (TAVR 3/1/12-11/1/14) Pre PT OT Pathway Implementation | Routine PT and or OT Routine PT or OT: Routine PT or OT consulted by physician when identified discharge disposition of home |
| FG001 | Intervention Group (TAVR 11/2/14-12/31/15) Post PT OT Pathway Implementation | Post procedure day zero nursing mobilization; post procedure day one PT and OT assessment and intervention, daily PT and OT intervention Post procedure daily PT and OT: PT evaluation and treatment on post procedure day zero: Nurses mobility patient using egress testing one time PT post procedure: post procedure day one: PT and OT assessment, education and intervention. OT post procedure: PT and OT Daily until goals met or patient discharge. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group (TAVR 3/1/12-11/1/14) Pre PT OT Pathway Implementation | Routine PT and or OT Routine PT or OT: Routine PT or OT consulted by physician when identified discharge disposition of home |
| BG001 | Intervention Group (TAVR 11/2/14-12/31/15) Post PT OT Pathway Implementation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post Procedure Hospital Length of Stay | From date of procedure until date of hospital discharge, assessed up to 50 days. | Adults admitted to Henry Ford Hospital and received a transcatheter aortic valve replacement via femoral access site and free from major events or complications. | Posted | Mean | Standard Deviation | days | at discharge |
|
This was a retrospective study.
This was a retrospective study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group (TAVR 3/1/12-11/1/14) Pre PT OT Pathway Implementation | Routine PT and or OT Routine PT or OT: Routine PT or OT consulted by physician when identified discharge disposition of home |
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One hospital in one area. Low subject number.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adele Myszenski, PT, DPT | Henry Ford Hospital | 313-916-1334 | amyszen1@hfhs.org |
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| PT post procedure | Other | post procedure day one: PT and OT assessment, education and intervention. |
|
| OT post procedure | Other | PT and OT Daily until goals met or patient discharge. |
|
| Routine PT or OT | Other | Routine PT or OT consulted by physician when identified discharge disposition of home |
|
At hospital discharge, did the patient return Home or were they discharged to a post-acute care Rehab Facility
| on day of hospital discharge |
| Background |
| Marcantuono R, Gutsche J, Burke-Julien M, Anwaruddin S, Augoustides JG, Jones D, Mangino-Blanchard L, Hoke N, Houseman S, Li R, Patel P, Stetson R, Walsh E, Szeto WY, Herrmann HC. Rationale, development, implementation, and initial results of a fast track protocol for transfemoral transcatheter aortic valve replacement (TAVR). Catheter Cardiovasc Interv. 2015 Mar;85(4):648-54. doi: 10.1002/ccd.25749. Epub 2014 Nov 29. |
| 28304219 | Background | Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M, Adams DH, Deeb GM, Maini B, Gada H, Chetcuti S, Gleason T, Heiser J, Lange R, Merhi W, Oh JK, Olsen PS, Piazza N, Williams M, Windecker S, Yakubov SJ, Grube E, Makkar R, Lee JS, Conte J, Vang E, Nguyen H, Chang Y, Mugglin AS, Serruys PW, Kappetein AP; SURTAVI Investigators. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2017 Apr 6;376(14):1321-1331. doi: 10.1056/NEJMoa1700456. Epub 2017 Mar 17. |
Post procedure day zero nursing mobilization; post procedure day one PT and OT assessment and intervention, daily PT and OT intervention Post procedure daily PT and OT: PT evaluation and treatment on post procedure day zero: Nurses mobility patient using egress testing one time PT post procedure: post procedure day one: PT and OT assessment, education and intervention. OT post procedure: PT and OT Daily until goals met or patient discharge. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Society of Thoracic Surgeons Risk Score | The Society of Thoracic Surgeons adult cardiac surgery risk model calculates patient's risk of mortality & morbidities for the most common cardiac surgeries; estimates should be considered as only 1 of several sources of information in decision-making and patient counseling. The STS score is a validated risk-prediction model for open surgery based on data from the STS National Adult Cardiac Surgery Database.1 In general, an STS predicted risk of surgical mortality of 4%-8% is considered intermediate risk and 8% or greater is considered high risk. J INVASIVE CARDIOL 2017;29(3):109-114 | Mean | Standard Deviation | Percentage |
|
| Valve Sheath Delivery Size | Society of Thoracic Surgeons Registry records the size of the catheter used during the tAVR procedure. Sizes range from 17.8 to 30.1. The latest generation of TAVR devices have incorporated features to reduce the delivery catheter profile, facilitate deployment, and enable repositioning and retrieval capability, with the aim of obtaining the desired position and reducing TAVR-related complications. https://citoday.com/pdfs/cit0317\_F5\_Barbanti.pdf This variable was initially an important way to control for the fact that over time from 2013 to 2015, smaller sizes can reduce complications. | Mean | Standard Deviation | milimeter diameter of tAVR device |
|
Post procedure day zero nursing mobilization; post procedure day one PT and OT assessment and intervention, daily PT and OT intervention
Post procedure daily PT and OT: PT evaluation and treatment on post procedure day zero: Nurses mobility patient using egress testing one time
PT post procedure: post procedure day one: PT and OT assessment, education and intervention.
OT post procedure: PT and OT Daily until goals met or patient discharge.
|
|
| Primary | Total Hospital Length of Stay | Days from Hospital admission to Hospital Discharge | Adults admitted to HFH and s/p tAVR via femoral site, free from events or complications | Posted | Mean | Standard Deviation | days | at discharge |
|
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|
|
| Secondary | Discharge Disposition, Home | Discharge destination at discharge. Home includes those discharge home, Home with assistance or Home with Home care. | Adults admit to HFH and s/p TAVR via femoral access, free from events or complications | Posted | Count of Participants | Participants | on day of hospital discharge |
|
|
|
| Secondary | Discharge Destination, Rehab Facility | At hospital discharge, did the patient return Home or were they discharged to a post-acute care Rehab Facility | Adults admit to HFH and s/p tavr via femoral, no events or complications | Posted | Count of Participants | Participants | on day of hospital discharge |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Intervention Group (TAVR 11/2/14-12/31/15) Post PT OT Pathway Implementation | Post procedure day zero nursing mobilization; post procedure day one PT and OT assessment and intervention, daily PT and OT intervention Post procedure daily PT and OT: PT evaluation and treatment on post procedure day zero: Nurses mobility patient using egress testing one time PT post procedure: post procedure day one: PT and OT assessment, education and intervention. OT post procedure: PT and OT Daily until goals met or patient discharge. | 0 | 0 | 0 | 0 |
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