Topics

Annuloplasty for Not-Severe TR in Patient Undergoing MV Repair Versus Mitral Repair Only (NOSTRUM)

2016-12-19 20:38:22 | BioPortfolio

Summary

The therapeutic strategy making in patients with ≤2 + functional tricuspid regurgitation (TR) is extremely controversial: some observational studies have suggested that perform the tricuspid annuloplasty in all patients undergoing mitral valve surgery have a dilated tricuspid ring, regardless of the degree of failure, may provide a clinical benefit, while in other observational studies such benefit has not been documented.

The ESC Guidelines assign the class IIa recommendation in patients with tricuspid regurgitation≥ 2+ and dilated annulus, if surgery is concomitant to the repair or replacement of the mitral valve; this means that although the debate still ongoing, experimental evidence or expert opinion is in favor of the effectiveness and usefulness of the intervention in the patient with these clinical features.

The aim of the study will be to establish the effectiveness of the tricuspid annuloplasty in the early stage. The investigators enrolled patient with TR≤2+ and annular dilation undergoing mitral valve repair.

Primary end-point will be the freedom from recurrence of TR≥3+ and from progression by 2 degrees compared to pre-operative, at discharge and 12 months after surgery, assessment by transthoracic echocardiography. Secondary endpoints are to demonstrate the superiority of combined treatment (M & T Repair Group) compared to single treatment (Mitral-Only Group) at 5 and 10 years after surgery.

This will be an experimental superiority, prospective, spontaneous, single-center, randomized trial.

Patients will be randomly assigned to two parallel arms with an allocation ratio 1:1, to receive mitral repair only (Mitral-Only group) ore both mitral and tricuspid repair (M & T Repair group).

Description

Current guidelines recommend surgical treatment of secondary tricuspid regurgitation (TR) in patients with mild or moderate TR undergoing mitral valve (MV) surgery if significant dilatation of the tricuspid annulus is documented. Indeed, several observational series and small randomized studies have shown that in the presence of tricuspid annulus dilatation, not treating less than severe secondary TR may lead to progression of the tricuspid disease despite correction of the associated left-sided lesion. The vast majority of those data, however, come from series that did not include patients with functional mitral regurgitation (MR) or included a very limited number of them. Only a few reports describe the evolution of mild or moderate TR in the context of dilated cardiomyopathy (DCM), and results are usually limited to early or mid-term follow-up. In the past, the concept that less than severe secondary TR decreases after MV surgery alone was widely accepted and the size of the tricuspid annulus was not used to guide the decision-making process in terms of TR correction.

The aim of the study will be to establish the effectiveness of the tricuspid annuloplasty in the early stage. The investigators enrolled patient with TR≤2+ and annular dilation undergoing mitral valve repair.

This will be a single center single-blind parallel group randomized controlled trial. Patients will be randomly assigned to two parallel arms with an allocation ratio 1:1, to receive one of two surgical procedures. Patients that will match the inclusion criteria at the preoperative evaluation will be recruited.

Patient will be randomized according to a computer-generated list of casual numbers. Information about patient allocation will be kept in closed opaque envelopes and nobody will know patient allocation before randomization. Patients will be blind to allocation.

The day of surgery patients will be subsequently randomized into two arms:

1. M & T Repair Group

2. Mitral-Only Group Each group will consist of 71 patients. All patients will receive the mitral valve repair and in patients enrolled in the M & T Repair Group an Edwards MC3 Tricuspid ring will be implanted.

Primary end-point will be the freedom from recurrence of TR≥3+ and from progression by 2 degrees compared to pre-operative, at discharge and 12 months after surgery, assessment by transthoracic echocardiography. Secondary endpoints are to demonstrate the superiority of combined treatment (M & T Repair Group) compared to single treatment (Mitral-Only Group) at 5 and 10 years after surgery.

For statistical analysis the data will be expressed as "average + or - standard deviation" or a percentage. A "probability value" less than 0.05 will be considered as "statistically significant." Outcomes will be compared using the "X2" analysis for categorical variables and the "t-test" for those continuous. The data will be analyzed using SPSS version 11.5 (SPSS Inc., Chicago, IL, USA) for Windows (Microsoft Corp, Redmond, WA). Survival and freedom from reoperation and TR≥3+ or TR progression> 2+ compared to preoperative, will be analyzed by the method of Kaplan-Meier. The analysis "univariate" and possibly "multivariate" of risk factors will be performed with "Cox proportional hazards regression".

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Tricuspid Disease

Intervention

M & T Repair Group, Mitral-Only Group

Location

Michele De Bonis
Milan
Italy
20132

Status

Recruiting

Source

Ospedale San Raffaele

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-12-19T20:38:22-0500

Clinical Trials [7220 Associated Clinical Trials listed on BioPortfolio]

PROphylactic triCuspID Annuloplasty in Patients With Dilated Tricuspid Annulus

Patients elected to undergo mitral valve surgery (either repair or replacement) with less equal than moderate (≤+2) tricuspid regurgitation and dilated tricuspid annulus (>21mm/m2) at pr...

Outcome of MC3 Ring Annuloplasty for Functional Tricuspid Regurgitation

This study includes 105 patients who underwent repair for ≥ moderate tricuspid regurgitation (TR) during mitral valve replacement for rheumatic valve disease. Between January 2016 and De...

Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery

The purpose of the research is to determine whether repairing a tricuspid valve (TV) in patients with mild to moderate tricuspid regurgitation (TR), at the time of planned mitral valve sur...

The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System

The purpose of the study is to assess the safety and device performance of the Edwards Tricuspid Transcatheter Repair System in patients with clinically significant, symptomatic, tricuspid...

Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation Study

The purpose of this study is to determine the utility of tricuspid valve repair at the time of LVAD implantation for patients presenting with moderate or severe tricuspid regurgitation. Th...

PubMed Articles [28001 Associated PubMed Articles listed on BioPortfolio]

Combined Tricuspid and Mitral Versus Isolated Mitral Valve Repair for Severe Mitral and Tricuspid Regurgitation: An Analysis From the TriValve and TRAMI Registries.

The aim of this study was to retrospectively compare the characteristics, procedural courses, and outcomes of patients presenting with concomitant mitral regurgitation (MR) and tricuspid regurgitation...

Evolution of Tricuspid Regurgitation after Repair of Degenerative Mitral Regurgitation.

The fate of unrepaired tricuspid regurgitation (TR) after mitral repair (MVr) for degenerative mitral regurgitation (MR) remains highly debated. The objective of this study was to examine the progress...

Concomitant Tricuspid Valve Repair during Minimally Invasive Mitral Valve Repair.

 Concomitant use of tricuspid valve (TV) surgery and minimally invasive mitral valve (MV) repair is debatable due to a prolonged time of surgery with presumably elevated operative risk. Herein, we e...

Should Moderate Functional Tricuspid Regurgitation be Repaired During Surgery for Rheumatic Mitral Valve Disease?

Surgical repair of concomitant functional moderate tricuspid valve (TV) regurgitation at the time of mitral valve (MV) surgery remains controversial.

Impact of abrupt versus gradual correction of mitral and tricuspid regurgitation: a modelling study.

Correction of mitral and/or tricuspid regurgitation (MR, TR) frequently leads to poor outcomes in the days following intervention. We sought to understand how abrupt correction of MR and TR affects ve...

Medical and Biotech [MESH] Definitions

A type of heart valve surgery that involves the repair, replacement, or reconstruction of the annulus of the MITRAL VALVE. It includes shortening the circumference of the annulus to improve valve closing capacity and reinforcing the annulus as a step in more complex valve repairs.

Abnormal protrusion of one or more of the leaflets of TRICUSPID VALVE into the RIGHT ATRIUM during SYSTOLE. This allows the backflow of blood into right atrium leading to TRICUSPID VALVE INSUFFICIENCY; SYSTOLIC MURMURS. Its most common cause is not primary valve abnormality but rather the dilation of the RIGHT VENTRICLE and the tricuspid annulus.

Backflow of blood from the LEFT VENTRICLE into the LEFT ATRIUM due to imperfect closure of the MITRAL VALVE. This can lead to mitral valve regurgitation.

The pathologic narrowing of the orifice of the TRICUSPID VALVE. This hinders the emptying of RIGHT ATRIUM leading to elevated right atrial pressure and systemic venous congestion. Tricuspid valve stenosis is almost always due to RHEUMATIC FEVER.

Abnormal protrusion or billowing of one or both of the leaflets of MITRAL VALVE into the LEFT ATRIUM during SYSTOLE. This allows the backflow of blood into left atrium leading to MITRAL VALVE INSUFFICIENCY; SYSTOLIC MURMURS; or CARDIAC ARRHYTHMIA.

More From BioPortfolio on "Annuloplasty for Not-Severe TR in Patient Undergoing MV Repair Versus Mitral Repair Only (NOSTRUM)"

Quick Search

Relevant Topics

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...

Cardiology
Cardiology is a specialty of internal medicine.  Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...


Searches Linking to this Trial