Reasons for Screen Failure for Transcatheter Mitral Valve Repair and Replacement

Forrestal, Brian J.; Khan, Jaffar M.; Torguson, Rebecca; Case, Brian C.; Safren, Lowell; Nasher, Nayeem; Reddin, Gemma; Satler, Lowell F.; Ben‐Dor, Itsik; Shults, Christian; Collins, Erin C.; Rogers, Toby; Waksman, Ron

doi:10.1016/j.amjcard.2021.02.022

Cited by 16 publications

(5 citation statements)

References 17 publications

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“…According to the present analysis of consecutive MR patients, most patients (65.0%) were deemed to be non-eligible for TMVR. In line with our findings, previous studies have reported that up to 75% of patients with MR are considered to have non-suitable mitral valve morphology for TEER and TMVR in their screening phase [22][23][24][25]. The other limitations of TMVR techniques are (1) the need for preprocedural contrast-enhanced CT scans and (2) the overall complexity of currently available devices.…”

supporting

confidence: 83%

Contemporary Treatment and Outcomes of High Surgical Risk Mitral Regurgitation

Sudo

Vij

Wilde

et al. 2023

JCM

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Before the development of transcatheter interventions, patients with mitral regurgitation (MR) and high surgical risk were often conservatively treated and subject to poor prognoses. We aimed to assess the therapeutic approaches and outcomes in the contemporary era. The study participants were consecutive high-risk MR patients from April 2019 to October 2021. Among the 305 patients analyzed, 274 (89.8%) underwent mitral valve interventions, whereas 31 (10.2%) received medical therapy alone. Of the interventions, transcatheter edge-to-edge mitral repair (TEER) was the most frequent (82.0% of overall), followed by transcatheter mitral valve replacement (TMVR) (4.6%). In patients treated with medical therapy alone, non-optimal morphologies for TEER and TMVR were shown in 87.1% and 65.0%, respectively. Patients undergoing mitral valve interventions experienced less frequent heart failure (HF) rehospitalization compared to those with medical therapy alone (18.2% vs. 42.0%, p < 0.01). Mitral valve intervention was associated with a lower risk of HF rehospitalization (HR 0.36 [0.18–0.74]) and an improved New York Heart Association class (p < 0.01). Most high-risk MR patients can be treated with mitral valve interventions. However, approximately 10% remained on medical therapy alone and were considered as unsuitable for current transcatheter technologies. Mitral valve intervention was associated with a lower risk of HF rehospitalization and improved functional status.

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supporting

confidence: 83%

Contemporary Treatment and Outcomes of High Surgical Risk Mitral Regurgitation

Sudo

Vij

Wilde

et al. 2023

JCM

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“…Our data shows that the largest determinant of screen failure for patients is 'not meeting the inclusion criteria' (54.9%). While well-framed, objective criteria maintain the integrity of a study, this finding suggests that increasingly strict or rigid criteria could be contributing to a large number of screen failures [3,4]. Due to the burden of a large number of screen failures, it may be worth looking into and analysing inclusion criteria to ensure a balance between maintaining integrity of data and not being overly rigid [5][6][7].…”

Section: Discussionmentioning

confidence: 99%

Audit of screen failure in 15 randomised studies from a low and middle-income country

Parekh¹,

Patil²,

Nawale³

et al. 2022

ecancer

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Background: Growth and development in patient management occurs via randomised studies. Screen failure is a significant hurdle while conducting randomised studies. There is limited data available from low and middle-income countries about factors resulting in screen failure. Hence, this audit was performed to identify the proportion of patients who screen failed and to elucidate reasons for the same. Methods:This was an audit of 15 randomised studies performed by medical oncology solid tumour unit II of Tata Memorial Centre. The screening logs of these studies were acquired. From the screening logs, data regarding the number of patients who had screen failed & reason for the same were obtained. Descriptive statistics were performed.Results: A total of 7,481 patients were screened for 15 randomised clinical studies. Out of these, 3,666 (49.0%) patients were enrolled into trials and 3,815 (51.0%) screen failed. The most common reason for screen failure was 'not meeting inclusion criteria' (54.9%) followed by declining to take treatment (22.2%). Other factors that affect enrolment were 'not willing to stay in the locality of the trial site' (6.2%), being recruited in other studies (3.7%), poor performance status (PS) (3.4%), non-compliance (2.2%), meeting exclusion criteria (0.9%) and 'other' (6.5%). Conclusion:The commonest causes of screen failure in lower and middle-income countries are non-meeting of inclusion criteria followed by declining to take treatment, not willing to stay in locality of trial site, recruited into other studies, poor PS, non-compliance, meeting exclusion criteria & 'other'. This information would help analysing and hence planning of newer strategies to decrease the rate of screen failure.

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“…Variable size, geometry, and non‐rigid nature of the annulus, as well as the need to anchor the prosthesis and potential for LV outflow tract obstruction (LVOTO) are well described ( Figure ). In a registry analysis of 563 TMVR eligible patients with screening failure, exclusion due to unfavourable anatomy (including annular size and risk of LVOTO) occurred in 13.7% 43 . Data from the TENDER registry 20 and Nikura et al 44 .…”

Section: Transapical Versus Transseptal Approachmentioning

confidence: 99%

“…In a registry analysis of 563 TMVR eligible patients with screening failure, exclusion due to unfavourable anatomy (including annular size and risk of LVOTO) occurred in 13.7%. 43 Data from the TENDER registry 20 and Nikura et al 44 .…”

Section: Transapical Versus Transseptal Approach Anatomical Complexit...mentioning

confidence: 99%

Peri‐procedural management of transcatheter mitral valve replacement in patients with heart failure

Hungerford

Dahle

Duncan

et al. 2022

European J of Heart Fail

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Over the past decade, transcatheter mitral valve replacement (TMVR) technologies have evolved with the objective of improving outcomes for patients with severe mitral regurgitation (MR) deemed unsuitable for conventional mitral valve surgery. Although the safety and efficacy of transcatheter edge‐to‐edge mitral valve repair (TEER) is well‐established, there is a sense amongst innovators that a major advantage of TMVR may be to offer a more complete solution for the correction of MR in patients whose complex anatomy means that the likelihood of achieving grade 0 or 1 MR with TEER is low. However, abrupt correction of MR in a poorly prepared left ventricle poses a number of unique haemodynamic challenges, particularly when sudden elimination of regurgitant flow causes a relative increase in left ventricular (LV) afterload. Rapid reduction in LV cavity size following MR elimination may itself result in relative LV outflow tract obstruction (LVOTO), irrespective of the intrinsic risk of LVOTO associated with TMVR. Nevertheless, TMVR on a beating heart affords the opportunity to study real‐time invasive cardiac indices in high‐risk patients with acute reversal of severe MR.

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Reasons for Screen Failure for Transcatheter Mitral Valve Repair and Replacement

Cited by 16 publications

References 17 publications

Contemporary Treatment and Outcomes of High Surgical Risk Mitral Regurgitation

Contemporary Treatment and Outcomes of High Surgical Risk Mitral Regurgitation

Audit of screen failure in 15 randomised studies from a low and middle-income country

Peri‐procedural management of transcatheter mitral valve replacement in patients with heart failure

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