Pathophysiology of ischemic mitral insufficiency: Does repair make a difference?

Gorman, Joseph H.; Ryan, Liam; Gorman, Robert C.

doi:10.1007/s10741-006-0101-9

Cited by 5 publications

(5 citation statements)

References 41 publications

(53 reference statements)

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“…before and after device implant) and the following parameters: 90% power, 1-sided 5% significance level, standard deviation of 8 and mean of 5% (assuming a baseline AHCWR of 15% and a postoperative value of 20% at 12 months). AHCWR values range from 20 to 30% when a mitral valve functions properly and from 10 to 17% for diseased valve [8][9][10][11][12]. The sample size calculated using the above parameters was 41 for MEMO 4D featuring a saddle-shape configuration (34−42 mm).…”

Section: Discussionmentioning

confidence: 99%

The MANTRA study: a new umbrella concept prospectively applied to assess implantable medical devices for heart valve procedures

Meuris¹,

Günaydın

Lancellotti

et al. 2023

J Cardiothorac Surg

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Background Clinical evidence is commonly obtained through individual trials that are time-, cost- and resource-consuming, and which often leave unanswered clinically relevant questions. Umbrella studies have been developed to address the need for more efficient and flexible trial structures, predominantly for cancer treatments. The umbrella concept foresees data collection within a unifying trial structure, to which one or more substudies may be added at any time to address product- or therapy-specific questions. To our knowledge, the umbrella concept has not yet been used in the medical device area, but it may offer similar advantages as in other settings, particularly in areas where multiple therapies are available within one large treatment area. Methods The MANTRA study (NCT05002543) is a prospective, global, post-marketing clinical follow-up study. The aim is to collect safety and device performance data covering the Corcym cardiac surgery portfolio for the treatment of aortic, mitral, and tricuspid valve diseases. The study uses a master protocol that outlines the main common parameters, and the specific questions are addressed in three substudies. The primary endpoints are device success at 30 days. Secondary endpoints include safety- and device performance-related data at 30 days, 1 year, and then annually through to 10 years. All endpoints are defined according to the more recent guidelines for heart valve procedures. Additionally, procedure and hospitalization information are collected, including Enhanced Recovery after Surgery in sites using such protocols, and patient outcome measures such as New York Heart Association classification and quality-of-life questionnaires. Results The study started in June 2021. Enrollment in all three substudies is ongoing. Conclusions The MANTRA study will provide contemporary information on the long-term outcomes of medical devices for the treatment of aortic, mitral, and tricuspid heart valve diseases in routine clinical practice. The umbrella approach adopted in the study has the potential of longitudinally assessing long-term efficacy of the devices and the flexibility to investigate new research questions as they arise.

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Section: Discussionmentioning

confidence: 99%

The MANTRA study: a new umbrella concept prospectively applied to assess implantable medical devices for heart valve procedures

Meuris¹,

Günaydın

Lancellotti

et al. 2023

J Cardiothorac Surg

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“…IMR at rest 1 and worsening of IMR during exercise in patients with chronic ischemic cardiomyopathy 4 carry an unfavorable effect on prognosis. Unfortunately, surgical repair of IMR has not been accompanied by an increase in survival in these patients 22 . Revascularization in patients with NSTACS improves the regional myocardial function 23 and this may attenuate the development or the progression of IMR in the long term.…”

Section: Discussionmentioning

confidence: 99%

“…Unfortunately, surgical repair of IMR has not been accompanied by an increase in survival in these patients. 22 Revascularization in patients with NSTACS improves the regional myocardial function 23 and this may attenuate the development or the progression of IMR in the long term. Therefore, patients with NSTACS and MR at rest or worsening of the regurgitation during exercise echocardiography could represent a subgroup that deserves particular attention.…”

Section: Discussionmentioning

confidence: 99%

Determinants of Exercise‐Induced Increase of Mitral Regurgitation in Patients with Acute Coronary Syndromes

et al. 2010

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“…Chronic IMR is a complex process that involves a combination of (1) annular dilatation plus flattening and (2) displacement of papillary muscles because of changes in function and geometry of the LV. The final result is a MV that shows a combination of Carpentier's class I (dilated annulus) and class IIIb (restricted leaflets tenting into the LV) mechanisms of MR. 12,13 The impact of ischemia-induced acute changes of ventricular wall motion on IMR is also a subject of debate and research. In a recent article, patients showing both ischemic heart disease and moderate MR and who planned to undergo CABG were assessed using low-dose (up to 10 μg/kg/min) dobutamine.…”

Section: Ischemic MV For Repairmentioning

confidence: 99%

Intraoperative TEE Assessment During Mitral Valve Repair for Degenerative and Ischemic Mitral Valve Regurgitation

Iglesias

2007

Semin Cardiothorac Vasc Anesth

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Pathophysiology of ischemic mitral insufficiency: Does repair make a difference?

Cited by 5 publications

References 41 publications

The MANTRA study: a new umbrella concept prospectively applied to assess implantable medical devices for heart valve procedures

The MANTRA study: a new umbrella concept prospectively applied to assess implantable medical devices for heart valve procedures

Determinants of Exercise‐Induced Increase of Mitral Regurgitation in Patients with Acute Coronary Syndromes

Intraoperative TEE Assessment During Mitral Valve Repair for Degenerative and Ischemic Mitral Valve Regurgitation

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