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Could not meet enrollment goal due to decrease in our target patient population (patients admitted for prehab).
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This study will aim to standardize the prehabilitation protocol to optimize patients and document the clinical and echo variables that could improve clinical outcomes of tricuspid valve intervention.
Prior to screening activities, each subject will be given an opportunity to ask questions and to understand the details of study participation. Subjects who meet the inclusion and exclusion criteria and have signed an informed consent form will be considered enrolled into the study. After a subject is consented and enrolled in the study, data will be collected prior to any intervention or surgery at the following time points: a) Screening/Baseline b) Day 1 of Prehab c) Day 2 of Prehab d) Day 3 of Prehab e) Day 4 of Prehab, f) and any data collected immediately prior to an intervention or incision (in the case of a surgical patient)
Subjects meeting eligibility criteria with planned tricuspid intervention will receive in-hospital optimization with THHBP's Prehab Protocol.
Prehabilitation will consist of careful pre-intervention assessment and personalized optimization, guided by Investigator judgment, with a specific focus on right ventricular function. This will be done by using a detailed echo acquisition protocol (Appendix 1). Assessments will be collected according to the schedule of events below (Table 1.). Therapy will include intravenous milrinone therapy and aggressive diuresis with evaluation for clinical and functional signs of improvement, according to standard of care. If there are clinical and functional signs of improvement before Day 4, and the subject is ready for TV surgery or any other intervention, they will have Day 4 procedures performed. After the tests and evaluations are completed, the Principal Investigator or Sub-Investigators will decide if the patient is a candidate for TV surgery or another intervention
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehabilitation | All study patients will receive preoperative optimization with a standardized prehabilitation protocol prior to any intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation | Other | Prehabilitation will consist of careful pre-intervention assessment and personalized optimization, guided by Investigator judgment, with a specific focus on right ventricular function. This will be done by using a detailed echo acquisition protocol (Appendix 1). Assessments will be collected according to the schedule of events below (Table 1.). Therapy will include intravenous milrinone therapy and aggressive diuresis with evaluation for clinical and functional signs of improvement, according to standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in volume status according to daily input/outputs | daily input/outputs (mL) | 4-5 days (Day 1 to Day 4 of Prehab or day of surgical intervention) |
| Change in volume status according to weight | daily weights (kg) | 5-6 days (Baseline to Day 4 of Prehab or day of surgical intervention) |
| Change in Severity of Tricuspid Regurgitation by Echocardiographic assessment | severity of tricuspid regurgitation (mild, moderate, severe) | 5 days (Baseline to Day 4 of Prehab) |
| Change in Nutritional Status | Pre-albumin (mg/dL) | 4 days (Baseline to Day 3 of Prehab) |
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Inclusion Criteria:
Exclusion Criteria:
1. Clinical instability according to the judgement of the Investigator
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40 adult male or female patients undergoing tricuspid valve intervention at The Heart Hospital Baylor Plano
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Scott & White Heart Hospital - Plano | Plano | Texas | 75093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29241483 | Background | Zack CJ, Fender EA, Chandrashekar P, Reddy YNV, Bennett CE, Stulak JM, Miller VM, Nishimura RA. National Trends and Outcomes in Isolated Tricuspid Valve Surgery. J Am Coll Cardiol. 2017 Dec 19;70(24):2953-2960. doi: 10.1016/j.jacc.2017.10.039. | |
| 30951698 | Background | Hamandi M, Smith RL, Ryan WH, Grayburn PA, Vasudevan A, George TJ, DiMaio JM, Hutcheson KA, Brinkman W, Szerlip M, Moore DO, Mack MJ. Outcomes of Isolated Tricuspid Valve Surgery Have Improved in the Modern Era. Ann Thorac Surg. 2019 Jul;108(1):11-15. doi: 10.1016/j.athoracsur.2019.03.004. Epub 2019 Apr 2. |
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We do not have a plan to shared IPD to researchers outside of our research team. We will make available aggregate data and results in the form of publications. Internal BSWH monitors will have access to IPD.
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| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000082622 | Preoperative Exercise |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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|
| 31805294 | Background | Hamandi M, George TJ, Smith RL, Mack MJ. Current outcomes of tricuspid valve surgery. Prog Cardiovasc Dis. 2019 Nov-Dec;62(6):463-466. doi: 10.1016/j.pcad.2019.11.014. Epub 2019 Dec 2. |
| D015444 |
| Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |