Transcatheter Aortic Valve Implantation
Conditions
Keywords
physical therapy, occupational therapy, tAVR
Brief summary
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.
Detailed description
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) * Improve patient outcomes including increasing the percentage of patients returning to home rather than a rehab facility destination at discharge * Decrease length of stay Implementation: * Plan: PT and OT identified a gap in consults and need for specific education targeted at a new surgeries population (tAVR); Structural Heart division of CV institute identified an increase LOS and decreased activity of their patients in the hospital. In October 2014 planning began to introduce a SHD tAVR pathway that would include post procedure day number 0 nursing requirements and training, post procedure day number 1-3 PT and OT assessment and interventions. * Do: Implemented pathway in November 2014. * Check: Order set revision; Patient handouts ; Cardiac Rehab; Weekend criteria; staff training * Act: February 2015, order sets in place, patient handouts finalized and full pathway finalized for post op tAVR patients. * Continued checks identified additional SHD procedures and team determined that Mitral Clips and LARIATs were not criteria for tAVR pathway but would receive routine PT and OT consults. Intervention: • Added PT and OT to Structural Heart Order Set. * PT and OT assessments completed on post procedure day number day 1. * PT and OT follow up treatments post procedure day number 2, 3 and beyond as appropriate. * Patient education handouts individualized for patient population * Pre-op education handouts individualized for patient population 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).
Interventions
PT evaluation and treatment on post procedure day zero: Nurses mobility patient using egress testing one time
post procedure day one: PT and OT assessment, education and intervention.
PT and OT Daily until goals met or patient discharge.
Routine PT or OT consulted by physician when identified discharge disposition of home
Sponsors
Study design
Eligibility
Inclusion criteria
* admission to henry ford hospital after March 1, 2012 * status post transcatheter aortic valve replacement via transfemoral catheter approach, with or without minor intra or post procedure events (GI bleeds, minor access bleeds, afib, etc)
Exclusion criteria
* Occurrence of major events including stroke, pacemaker placement, other CV repair or surgery required, etc) * procedure via appropriate other than femoral access (transapical, transcaval)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Procedure Hospital Length of Stay | at discharge | From date of procedure until date of hospital discharge, assessed up to 50 days. |
| Total Hospital Length of Stay | at discharge | Days from Hospital admission to Hospital Discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Discharge Disposition, Home | on day of hospital discharge | Discharge destination at discharge. Home includes those discharge home, Home with assistance or Home with Home care. |
| Discharge Destination, Rehab Facility | on day of hospital discharge | At hospital discharge, did the patient return Home or were they discharged to a post-acute care Rehab Facility |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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 | 74 |
| 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. | 115 |
| Total | 189 |
Baseline characteristics
| Characteristic | Control Group (TAVR 3/1/12-11/1/14) Pre PT OT Pathway Implementation | Intervention Group (TAVR 11/2/14-12/31/15) Post PT OT Pathway Implementation | Total |
|---|---|---|---|
| Age, Continuous | 79.5 years STANDARD_DEVIATION 11.2 | 81.6 years STANDARD_DEVIATION 8.4 | 80.6 years STANDARD_DEVIATION 9.8 |
| BMI | 28.4 kg/m^2 STANDARD_DEVIATION 6.2 | 28.4 kg/m^2 STANDARD_DEVIATION 6.1 | 28.4 kg/m^2 STANDARD_DEVIATION 6.2 |
| Region of Enrollment United States | 74 participants | 115 participants | 189 participants |
| Sex: Female, Male Female | 32 Participants | 47 Participants | 79 Participants |
| Sex: Female, Male Male | 42 Participants | 68 Participants | 110 Participants |
| Society of Thoracic Surgeons Risk Score | 8.5 Percentage STANDARD_DEVIATION 8.5 | 7.0 Percentage STANDARD_DEVIATION 4.6 | 7.75 Percentage STANDARD_DEVIATION 6.6 |
| Valve Sheath Delivery Size | 18.1 milimeter diameter of tAVR device STANDARD_DEVIATION 4.2 | 19.3 milimeter diameter of tAVR device STANDARD_DEVIATION 3.8 | 18.7 milimeter diameter of tAVR device STANDARD_DEVIATION 4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Post Procedure Hospital Length of Stay
From date of procedure until date of hospital discharge, assessed up to 50 days.
Time frame: at discharge
Population: Adults admitted to Henry Ford Hospital and received a transcatheter aortic valve replacement via femoral access site and free from major events or complications.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group (TAVR 3/1/12-11/1/14) Pre PT OT Pathway Implementation | Post Procedure Hospital Length of Stay | 4.8 days | Standard Deviation 2.9 |
| Intervention Group (TAVR 11/2/14-12/31/15) Post PT OT Pathway Implementation | Post Procedure Hospital Length of Stay | 3.5 days | Standard Deviation 4 |
Total Hospital Length of Stay
Days from Hospital admission to Hospital Discharge
Time frame: at discharge
Population: Adults admitted to HFH and s/p tAVR via femoral site, free from events or complications
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group (TAVR 3/1/12-11/1/14) Pre PT OT Pathway Implementation | Total Hospital Length of Stay | 6.9 days | Standard Deviation 5.4 |
| Intervention Group (TAVR 11/2/14-12/31/15) Post PT OT Pathway Implementation | Total Hospital Length of Stay | 4.5 days | Standard Deviation 5.4 |
Discharge Destination, Rehab Facility
At hospital discharge, did the patient return Home or were they discharged to a post-acute care Rehab Facility
Time frame: on day of hospital discharge
Population: Adults admit to HFH and s/p tavr via femoral, no events or complications
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group (TAVR 3/1/12-11/1/14) Pre PT OT Pathway Implementation | Discharge Destination, Rehab Facility | 17 Participants |
| Intervention Group (TAVR 11/2/14-12/31/15) Post PT OT Pathway Implementation | Discharge Destination, Rehab Facility | 16 Participants |
Discharge Disposition, Home
Discharge destination at discharge. Home includes those discharge home, Home with assistance or Home with Home care.
Time frame: on day of hospital discharge
Population: Adults admit to HFH and s/p TAVR via femoral access, free from events or complications
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group (TAVR 3/1/12-11/1/14) Pre PT OT Pathway Implementation | Discharge Disposition, Home | 57 Participants |
| Intervention Group (TAVR 11/2/14-12/31/15) Post PT OT Pathway Implementation | Discharge Disposition, Home | 99 Participants |