LUS in Aortic Stenosis Patients Undergoing TAVR

August 26, 2021 updated by: Francesco Burzotta, Catholic University of the Sacred Heart

Lung Ultrasound in Aortic Stenosis Patients Undergoing Transcatheter Aortic Valve Replacement: a Prospective Study

  1. Introduction and aims:

    Transcatheter aortic valve replacement (TAVR) is the gold standard for the treatment of elderly patients with severe aortic valve stenosis (AS). AS causes left ventricular remodeling as well as left atrial enlargement, pulmonary artery and right ventricular changes, these changes, and whether they are reversible (reverse remodeling) are major determinants of outcome after TAVR. Heart Failure (HF) is the most frequent cause of cardiac re-hospitalization after TAVR. Most HF exacerbations are related to a progressive rise in cardiac filling pressures that precipitates pulmonary congestion and symptomatic decompensation. Traditionally, pulmonary congestion has been assessed by physical examination and chest radiography but clinical signs and symptoms of congestion are poor surrogates for ventricular filling pressures and are not reliable predictors of imminent hospitalization. Recently, lung ultrasonography (LUS) has been identified as a sensitive and semi-quantitative tool for the assessment of pulmonary congestion in HF. The technique is based on the detection of vertical echogenic artifacts arising from the pleural line, named "B-lines". The number of B-lines is associated with increased risk of adverse events during hospitalization and after hospital discharge. CLUSTER-HF Trial demonstrated that the routine incorporation of LUS during clinical follow-up of patients with recent acute decompensated HF without a surgically correctable cause, was associated with a risk reduction of adverse HF events, mainly urgent HF visits.

    Thus, LUS could represent a promising tool to detect pulmonary congestion related to AS. To date, there are no studies on the role of LUS in the context of AS and TAVR.

    The study hypothesis is that in patients with higher number of B-lines before-TAVR and after TAVR, the rate of adverse events during follow-up is higher.

  2. Study design:

    This is a single center prospective study carried out at Fondazione Policlinico Gemelli IRCCS, Roma and involving patients with severe aortic stenosis submitted to TAVR treatment. The expected recruitment period is approximately one year For patients fulfilling inclusion/exclusion criteria, all data about clinical status leading to TAVR, exams and any specific documentation during hospitalization will be collected.

  3. Number of patients:

    For the primary end-point, a sample-size of 91 is computed using the one-sample chi-square test and assuming a proportion of LUS-evaluated pulmonary congested patients before TAVR of 50% and a proportion of 35% of LUS-evaluated pulmonary congested patients after TAVR. To accommodate for possible missing investigations, sample size will be increased to 105 patients.

    The secondary end-point is the association between pre-TAVR and post-TAVR B-lines and long-term outcomes. Based on previous studies, the investigators know that the incidence of rehospitalization for heart failure during one-year after TAVR is 14% and that patients suffering from heart failure without LUS-evaluated pulmonary congestion are at very low risk of heart failure rehospitalization during follow-up. So, for sample size calculation of the secondary endpoint, the investigators estimated a cumulative incidence higher in the LUS- evaluated pulmonary congestion group with more than 16 B-lines on all scanning sites (30% of events during 1-year of follow-up) with a lower incidence of 8% in the remaining patients. With an HR of 5 favoring patients wit less than 15 B-Lines on all scanning, and aiming to a 2-sided alpha level of 0.05 and a power of 80% the investigators estimated 144 patients. To accommodate for possible missing investigations, sample size will be increased to 150 patients.

  4. In-hospital study schedule:

    For each patient, the investigators will obtain from our general hospital database the following clinical data:

    • Demographic and clinical data documentation;
    • Clinical examination: before TAVR, before discharge and when adverse events occur;
    • Blood analysis;
    • TAVR procedural characteristics and complications.

  5. Instrumental diagnostic exams (Echocardiography and lung ultrasound):

    Each patient will be evaluated before and after TAVR with a comprehensive echocardiogram and LUS for the evaluation of the pulmonary congestion. All the evaluations will be performed the day before TAVR and after TAVR.

    In consideration of the operator's dependence on ultrasound methods to reduce the error rate, all examinations will be performed by qualified personnel.

  6. Clinical follow up assessment:

Clinical follow up information will be obtained from: visits, review of the patient's hospital record, personal communication with the patient's physician and review of the patient's chart, a telephone interview with the patient conducted by trained medical personnel The following information will be recorded: clinical status assessment, adverse event assessment, record cardiac medications.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Recruiting
        • Policlinico A. Gemelli. Università Cattolica del Sacro Cuore
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing TAVR for severe aortic stenosis could participate in the study and therefore, be evaluated according to the selection criteria defined in the protocol.

Description

Inclusion Criteria:

  • severe aortic stenosis,
  • life expectancy >1 year,
  • patient candidate to percutaneous transfemoral aortic valve implantation after formal indication of our "Heart Team".

Exclusion Criteria:

  • clinical history of lung cancer or lung surgery, fibrothorax and pneumothorax, pulmonary fibrosis,
  • patients undergoing urgent aortic valvuloplasty,
  • patients admitted for cardiogenic shock,
  • recent (within 1 month) pneumonia or ARDS (Acute Respiratory Distress Syndrome),
  • lack of will to participate,
  • more than moderate aortic regurgitation,
  • valve-in-valve procedures,
  • transapical and transaortic TAVR.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Severe aortic stenosis patients undergoing TAVR
Severe aortic stenosis patients undergoing TAVR will be stratified according to LUS evaluated pulmonary congestion before and after TAVR
Procedure: Transfemoral TAVR (Transcatheter aortic valve replacement)
Transfemoral transcatheter aortic valve replacement (TAVR) is a minimally invasive heart procedure to replace a narrowed aortic valve that fails to open properly (aortic valve stenosis) through an incision in the groin. All FDA approved transcatheter aortic prosthesys are allowed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of LUS-evaluated pulmonary congestion in patients with severe aortic stenosis undergoing TAVR
Time Frame: pre-intervention (baseline) and after the intervention within 72 hours
pre-intervention (baseline) and after the intervention within 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to evaluate the possible prognostic role of LUS-evaluated pulmonary congestion at 12 months follow-up.
Time Frame: One year after hospital discharge.
The main adverse events considered in the secondary end-point are: death from cardiovascular cause, hospitalization for HF and urgent medical visits for worsening dyspnea in the 12 months following discharge
One year after hospital discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Collaborators

Francesca Graziani, MD
Stefano Cangemi, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2021

Primary Completion (Anticipated)

April 30, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

August 10, 2021

First Submitted That Met QC Criteria

August 26, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Actual)

August 27, 2021

Last Update Submitted That Met QC Criteria

August 26, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID 3965

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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