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Physical Therapy and Occupational Therapy After Transcatheter Aortic Valve Replacement

Physical Therapy and Occupational Therapy After Transcatheter Aortic Valve Replacement

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03117296
Acronym
PTOTtAVR
Enrollment
189
Registered
2017-04-17
Start date
2014-12-03
Completion date
2017-12-31
Last updated
2023-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transcatheter Aortic Valve Implantation

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

OTHERPost procedure daily PT and OT

PT evaluation and treatment on post procedure day zero: Nurses mobility patient using egress testing one time

OTHERPT post procedure

post procedure day one: PT and OT assessment, education and intervention.

OTHEROT post procedure

PT and OT Daily until goals met or patient discharge.

OTHERRoutine PT or OT

Routine PT or OT consulted by physician when identified discharge disposition of home

Sponsors

Henry Ford Hospital
CollaboratorOTHER
Henry Ford Health System
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

MeasureTime frameDescription
Post Procedure Hospital Length of Stayat dischargeFrom date of procedure until date of hospital discharge, assessed up to 50 days.
Total Hospital Length of Stayat dischargeDays from Hospital admission to Hospital Discharge

Secondary

MeasureTime frameDescription
Discharge Disposition, Homeon day of hospital dischargeDischarge destination at discharge. Home includes those discharge home, Home with assistance or Home with Home care.
Discharge Destination, Rehab Facilityon day of hospital dischargeAt 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

ArmCount
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
Total189

Baseline characteristics

CharacteristicControl Group (TAVR 3/1/12-11/1/14) Pre PT OT Pathway ImplementationIntervention Group (TAVR 11/2/14-12/31/15) Post PT OT Pathway ImplementationTotal
Age, Continuous79.5 years
STANDARD_DEVIATION 11.2
81.6 years
STANDARD_DEVIATION 8.4
80.6 years
STANDARD_DEVIATION 9.8
BMI28.4 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 participants115 participants189 participants
Sex: Female, Male
Female
32 Participants47 Participants79 Participants
Sex: Female, Male
Male
42 Participants68 Participants110 Participants
Society of Thoracic Surgeons Risk Score8.5 Percentage
STANDARD_DEVIATION 8.5
7.0 Percentage
STANDARD_DEVIATION 4.6
7.75 Percentage
STANDARD_DEVIATION 6.6
Valve Sheath Delivery Size18.1 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 typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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.

ArmMeasureValue (MEAN)Dispersion
Control Group (TAVR 3/1/12-11/1/14) Pre PT OT Pathway ImplementationPost Procedure Hospital Length of Stay4.8 daysStandard Deviation 2.9
Intervention Group (TAVR 11/2/14-12/31/15) Post PT OT Pathway ImplementationPost Procedure Hospital Length of Stay3.5 daysStandard Deviation 4
Primary

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

ArmMeasureValue (MEAN)Dispersion
Control Group (TAVR 3/1/12-11/1/14) Pre PT OT Pathway ImplementationTotal Hospital Length of Stay6.9 daysStandard Deviation 5.4
Intervention Group (TAVR 11/2/14-12/31/15) Post PT OT Pathway ImplementationTotal Hospital Length of Stay4.5 daysStandard Deviation 5.4
Comparison: Univariate 2-group comparisons were performed using χ2 and Fisher's exact tests (when expected cell counts are \<5) for categorical variables, using 2-group t tests and Wilcoxon rank-sum tests (when normality distributions were violated) for continuous variables. Statistical significance was set at P \< .05. All analyses were performed using SAS 9.4 (SAS Institute, Cary, North Carolina).p-value: <0.01Fisher Exact
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Control Group (TAVR 3/1/12-11/1/14) Pre PT OT Pathway ImplementationDischarge Destination, Rehab Facility17 Participants
Intervention Group (TAVR 11/2/14-12/31/15) Post PT OT Pathway ImplementationDischarge Destination, Rehab Facility16 Participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Control Group (TAVR 3/1/12-11/1/14) Pre PT OT Pathway ImplementationDischarge Disposition, Home57 Participants
Intervention Group (TAVR 11/2/14-12/31/15) Post PT OT Pathway ImplementationDischarge Disposition, Home99 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026