Clinical trial NCT03117296: Physical Therapy and Occupational Therapy After Transcatheter Aortic Valve Replacement
Official title: Physical Therapy and Occupational Therapy After Transcatheter Aortic Valve Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transcatheter Aortic Valve Implantation
Keywords: physical therapy
occupational therapy
tAVR
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Henry Ford Hospital
First posted: 2017-04-17
Enrollment: 189
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Post Procedure Hospital Length of Stay
timeFrame: at discharge
measure: Total Hospital Length of Stay
timeFrame: at discharge
Secondary outcomes:
measure: Discharge Disposition, Home
timeFrame: on day of hospital discharge
measure: Discharge Destination, Rehab Facility
timeFrame: on day of hospital discharge
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Adele Myszenski, MPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.