RecruitingACTRN12624000571572

Identifying patients suitable for same day discharge after Transcatheter Aortic Valve Implantation (NORTH SHORE DAY STAY TAVI)

Prospective observational study to accurately identify patients suitable for same day discharge after Transcatheter Aortic Valve Implantation in both self-expanding and balloon-expandable valves


Sponsor

Department of Cardiology, Royal North Shore Hospital

Enrollment

59 participants

Start Date

Feb 8, 2024

Study Type

Observational

Conditions

Summary

Next day discharge after transcatheter aortic valve implantation (TAVI) has been shown to be safe and is now commonly implemented in clinical practice. A small number of studies have investigated same day discharge (SDD) after TAVI, but more studies are needed, particularly in self-expanding valves. This study will prospectively apply a locally derived discharge protocol to all consecutive patients undergoing elective, transfemoral TAVI procedures at our centres. The study aims to determine if the NORTH SHORE DAY-STAY TAVI clinical pathway effectively identifies patients who are at low risk of post-procedural complications and to evaluate if they can be safely discharged on the same day following transfemoral transcatheter aortic valve implantation (tf-TAVI). The project will measure endpoints including all-cause mortality, stroke, major bleeding, major vascular complication, new renal replacement therapy and high-grade AV block during index hospitalization and at 30-day follow up.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure to replace a narrowed heart valve without open-heart surgery. Until recently, patients spent several days in hospital recovering after TAVI. Over time, hospitals have found that many patients can safely go home the next day. A smaller number of studies have looked at whether same-day discharge might be safe for carefully selected patients — but this has not been studied widely, particularly for self-expanding valve types. This study will apply a locally developed discharge protocol to all consecutive patients having an elective TAVI at participating centres, prospectively tracking who is identified as low risk and discharged the same day. The study will measure safety outcomes including death, stroke, major bleeding, major vascular complications, and need for a pacemaker over 30 days. You may be eligible if you are having an elective TAVI procedure via the femoral artery (in the groin) at a participating centre. Non-elective TAVI procedures or those performed via a non-femoral approach are not included in this study.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This study aims to determine if the NORTH SHORE DAY STAY TAVI clinical pathway effectively identifies patients who are low-risk of post-procedural complications and suitable for same day discharge (SD

This study aims to determine if the NORTH SHORE DAY STAY TAVI clinical pathway effectively identifies patients who are low-risk of post-procedural complications and suitable for same day discharge (SDD) after transfemoral Transcatheter Aortic Valve Implantation (TAVI). As part of the study, the clinical pathway will be applied to all patients undergoing transfemoral elective TAVI procedures at the included study sites. The NORTH SHORE DAY STAY TAVI clinical pathway involves comprehensive preprocedural, intraprocedural and postprocedural assessments to identify suitable patients and assess for early signs of complications. Postprocedural assessment will occur at 4-6 hours after TAVI. During that assessment the physician will assign the patient as either being suitable (NORTH SHORE DAY-STAY TAVI Score = 0) or unsuitable (NORTH SHORE DAY-STAY TAVI Score >= 1) for same day discharge based on objective screening criteria. Preprocedural requirements specified in the clinical pathway are non-urgent, elective TAVI, age greater than or equal to 18 years old, mobilising and living independently, adequate social supports to facilitate recovery at home and no significant medical comorbidities that necessitated additional in-hospital monitoring such as end stage renal disease or advanced dementia. Patients are additionally excluded if there was a right bundle branch block (RBBB) or atrioventricular block (AVB) on baseline ECG, unless the patient has a permanent pacemaker. Procedural requirements include no general anaesthesia (conscious sedation or local anaesthetic only), no high-grade AVB during valve deployment, no recorded intraprocedural complications and temporary pacing wires removed at the end of the case. Postprocedural requirements include: (1) no evidence of delirium, (2) no evidence of vascular access site complications such as haematoma or pseudoaneurysm, (3) no abnormal transthoracic echocardiogram features (LVEF > 30%, none or mild paravalvular leak, no new pericardial effusion and functioning implanted valve), (4) no new conduction abnormalities (new AVB including first degree block, or bundle branch block) unless the patient had a permanent pacemaker, (5) ability to mobilise 20 metres (assessed using the patient’s regular mobility aids) and (6) structural heart team review, together with patient and their family, to provide a final approval for SDD. A bedside duplex femoral ultrasound is the only additional assessment that is not part of standard care that will be required for included patients. Patients that undergo SDD will then be discharged with in-person review in a clinic the following day. Patients will again be followed up at 30 days after their TAVI to assess for outcome measures including all-cause mortality, rehospitalization and other complications. Follow up will involve a 15-30 minute in-person clinic review or telephone interview (if there are logistic and travel constraints such as regional or interstate patients) for patients. An additional review of medical records by the Research team will be performed to corroborate data collected and ensure comprehensive assessment for adverse events. Review by the patients regular treating Cardiologist and repeat transthoracic echocardiogram at 30 days after TAVI that is required by the study is part of standard care. Collection of this data will be performed by the Research Team. The following information will be collected for the study: - Patient demographics and clinical information (medical history and medication history) - Baseline clinical scores (quality of life measures, surgical risk score) - Baseline and post TAVI blood tests (haemoglobin, creatinine, albumin) - Pre and post TAVI echocardiograms (TTE) - Pre and post TAVI ECGs - CT (Computed Tomography) TAVI result (this is a pre-TAVI requirement, and is not an extra step of the research study) - TAVI procedure details (valve type and/or any complications) - Post-TAVI inpatient outcomes and clinical pathway score - Adverse events and complications that may have occurred, until 1 month after TAVI


Locations(2)

Royal North Shore Hospital - St Leonards

NSW, Australia

North Shore Private Hospital - St Leonards

NSW, Australia

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ACTRN12624000571572


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