Skip to main content
Erschienen in: Journal of Cardiothoracic Surgery 1/2022

Open Access 01.12.2022 | Research

Subannular repair for functional mitral regurgitation with reduced systolic ventricle function: rationale and design of REFORM-MR registry

verfasst von: Evaldas Girdauskas, Jonas Pausch, Hermann Reichenspurner, Jörg Kempfert, Thomas Kuntze, Tamer Owais, Tomas Holubec, Markus Krane, Keti Vitanova, Michael Borger, Matthias Eden, Violetta Hachaturyan, Peter Bramlage, Volkmar Falk

Erschienen in: Journal of Cardiothoracic Surgery | Ausgabe 1/2022

Abstract

Background

Functional mitral regurgitation (FMR) is one of the most common heart valve diseases that is a sequel of left ventricular remodelling. Although mitral valve annuloplasty is a standard treatment of FMR, the recurrence of FMR is a major drawback and occurs in 10–50% of patients. The REFORM-MR registry aims to investigate the effectiveness of standardized papillary muscle relocation and ring annuloplasty and to identify the risk factors associated with recurrent FMR.

Methods

REFORM-MR is a prospective, multicenter registry that enrols consecutive FMR patients across five sites in Germany. All patients with FMR and restricted movement of leaflets during systole (i.e., type IIIb mitral regurgitation) undergoing standardized subannular repair in combination with mitral valve annuloplasty are included in the study. The primary objective is to examine the effect of combined papillary muscle relocation and ring annuloplasty on the recurrence of FMR at 2 years postoperatively. The secondary objectives are MACCE rate, reinterventions on the mitral valve and cardiac-related mortality in the study cohort. Echocardiography core-lab and MRI core-lab will provide anonymized analysis of the imaging data in the REFORM-MR registry. Student’s t-test or Mann–Whitney U test for continuous variables and the Chi-Square or Fisher exact test for categorical variables are used for group comparisons. Kaplan–Meier analyses is performed for survival and safety outcomes.

Results

As of May 2021, a total of 97 patients were enrolled across five sites in Germany.

Conclusions

The results of this study will help define the outcomes of combined papillary muscle relocation and ring annuloplasty in the FMR treatment in a multicentre setting and to improve the understanding of the limitations of subannular repair procedures while treating patients with type III FMR.
Trial registration clinicaltrials.gov Identifier: NCT03470155.
Hinweise

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Abkürzungen
DICOM
Digital Imaging and Communication in Medicine
ECG
Electrocardiogram
eCRF
Electronic case report form
FMR
Functional mitral regurgitation
IQR
Interquartile range
LV
Left ventricle
MACCE
Major Adverse Cardiac and Cerebrovascular Events
MR
Mitral regurgitation
MVr
Mitral valve repair
SD
Standard deviation
QoL
Quality of life

Background

Mitral regurgitation (MR) is one of the most common valvular diseases in adults that affects more than 2% of the general population worldwide and has an increasing prevalence with age [1]. Functional (or secondary) mitral regurgitation (FMR) results from annular dilation (i.e., type I MR) and/or apico-lateral papillary muscle displacement due to left ventricular (LV) remodelling (type IIIb MR). LV enlargement with the resulting geometric dislocation of the papillary muscles and increased distance between papillary muscle tips and mitral annular plane leads to restricted systolic motion of the mitral valve leaflets (so-called mitral valve tethering) [2]. FMR is associated with increased morbidity and mortality [3]. The treatment of FMR has significantly changed over the last decades, while mitral valve annuloplasty remains the most frequently used surgical technique. However, despite the fact that mitral valve annuloplasty has been shown to reduce the severity of FMR and improve the heart failure symptoms in the short term, it has also been associated with a high recurrence rate of FMR [46].
The recurrence rate of moderate to severe FMR in patients during follow-up after mitral valve annuloplasty has been reported in the range of 10–50%, resulting in an increased long-term mortality, new or worsening heart failure, and compromised quality of life (QoL) [5, 7, 8]. A number of studies examined technical and clinical factors that may reduce the risk of FMR recurrence after mitral valve repair (MVr), including the cause of FMR, type of the surgical procedure, anatomical characteristics of the mitral valve, and pre-existing medical conditions [5]. However, there is still an urgent clinical demand to identify reliable pre-procedural parameters that may predict MVr failure and FMR recurrence.
A subgroup of FMR patients presented with echocardiographic evidence of reverse LV remodelling after an isolated ring annuloplasty, while a continued LV remodelling was observed in the remaining FMR patients despite an initially successful mitral valve annuloplasty [9, 10]. In the case of progressive LV remodelling, recurrent FMR is mostly due to increasing leaflet tethering. This is because the ring annuloplasty primarily targets mitral valve annulus dilation and does not relieve leaflet tethering due to papillary muscle displacement. To address the tethering issue, several subannular repair techniques have been developed to ameliorate the drawbacks of isolated ring annuloplasty. Subannular techniques describe a wide spectrum of surgical manoeuvres, including cutting of the secondary chordae, patch augmentation of the posterior or anterior mitral leaflet, papillary muscle approximation, and papillary muscle relocation [1114]. A recent meta-analysis has highlighted potential advantages of combining ring annuloplasty with a papillary muscle intervention to enable a complete geometric MVr and thereby to reduce the recurrence rate of FMR [15]. However, due to lack of robust data on FMR treatment from well-designed, prospective, multicenter trials, clinical adoption of papillary muscle techniques is still very limited.
We designed the prospective, multicentre REFORM-MR registry to assess the feasibility and efficacy of a combined subannular repair by relocation of papillary muscles and ring annuloplasty to reduce the risk of recurrent FMR in patients with type IIIb MR. In addition, we aimed to identify pre-procedural characteristics and echocardiographic parameters that may predict FMR recurrence after such procedure. Taken together, these findings could provide strong evidence for standardization and consistency in the clinical practice while treating patients with the type IIIb FMR.

Methods/design

REFORM-MR is a prospective, observational, multicenter registry with a follow-up of 2 years to assess the effectiveness of standardized subannular repair by papillary muscle relocation and annuloplasty on the FMR recurrence, Major Adverse Cardiac and Cerebrovascular Events (MACCE), and QoL at 2 years following surgery. The registry was registered at www.​clinicaltrials.​gov, Identifier NCT03470155.

Participating sites

Sites were selected based on recommendations of the principal investigator and included only high-volume surgical centers in Germany performing > 100 mitral valve surgery cases/year. The prerequisites for site’s participation were an extensive experience in mitral valve surgery, including minimally invasive techniques, and the site’s readiness in using the standardized subannular repair technique in consecutive FMR patients.
In preselected centers, the most experienced mitral surgeons were included and all of them had mitral valve case-load > 50 procedures/year over the last years. The training program in all participating centers included a theoretical teaching unit, visiting of the Core center with a watching of live-surgery, and an individual proctoring of the first 2–4 cases by the first author of  the manuscript.

Patients

Patients were enrolled in the registry based on the following inclusion criteria: (1) presence of FMR with impaired movement of leaflets during systole (type IIIb)—effective regurgitation orifice area more than 20 mm2/regurgitant volume more than 30 ml/beat, (2) left ventricular ejection fraction less than 50%, (3) left ventricular end-diastolic diameter of at least 55 mm, and (4) tenting height of the posterior and/or anterior mitral leaflets > 10 mm (Table 1). Patients were excluded based on the exclusion criteria summarized in Table 1. Written informed consent was obtained from all patients prior to enrolment and compliance with the Declaration of Helsinki was ensured throughout the trial.
Table 1
REFORM-MR inclusion/exclusion criteria
Inclusion criteria
Exclusion criteria
Presence of FMR with impaired movement of leaflets during systole (type IIIb)—effective regurgitation orifice area greater than 20 mm2/regurgitant volume more than 30 ml/beat
Prolapse of anterior or posterior mitral valve leaflet (type II MR)
Left ventricular ejection fraction < 50% and/or left ventricular end-diastolic diameter ≥ 55 mm
Combined procedure with simultaneous aortic valve surgery
Tenting of the posterior and/or anterior mitral leaflet > 10 mm
Redo surgery of the mitral valve
 
Previous coronary artery bypass graft (CABG) or valvular surgery (aortic, mitral, tricuspid)
 
Degenerative mitral valve disease (e.g., extensive annulus calcification or leaflet/chordae fibrosis/restriction)
 
Type I MR without leaflet tethering (i.e., atrial FMR)

Preoperative assessment

As part of a mandatory preoperative screening, transthoracic echocardiogram (TTE), stress echocardiography, blood test, and 6-minute walk test were performed in all patients. QoL was also assessed in all patients using the SF-12 Health Survey. Cardiac magnetic resonance imaging (MRI) was performed in patients with no contraindications for a cardiac MRI in order to determine the ventricular functional reserve.

Surgical technique

The technique of subannular repair by relocation of both papillary muscles has been described in detail previously (Fig. 1) [16]. The Carpentier-McCarthy-Adams IMR ETlogix annuloplasty ring (Edwards Lifesciences, Irvine, CA, USA) with a reduced antero-posterior diameter was used for a true-sized annuloplasty in all study patients. Briefly, double-armed pledgeted 3–0 Polytetrafluoroethylene sutures are passed through the trunks of both papillary muscles (i.e., anterolateral and posteromedial) in a U-formed fashion. Both suture ends are subsequently passed through the posterior mitral valve annulus from the ventricular to atrial side. Further, both sutures are retrieved outside the chest and secured for later use after placement of the annuloplasty ring. Next, the annuloplasty ring is being lowered down on the native mitral annulus while both sutures are kept outside the ring. After ring sutures are completely tied thereby securing the annuloplasty ring, both sutures are passed through the posterior aspect of the annuloplasty ring. In the next step of procedure, ”physiological” LV geometry is mimicked by filling the LV with a cold saline and thereby inducing a maximally possible tenting of mitral leaflets. While the LV is maximally filled, stepwise traction is applied to both sutures until leaflet tethering disappears and a mild “pseudoprolapse” of anterior mitral leaflet occurs. Both sutures are tightly knotted while keeping this traction and the knots are additionally secured with hemoclips. This maneuver allows for a very controlled realignment of both papillary muscles, reaching an appropriate distance between papillary muscle tips and mitral annular plane [16].

Objectives

The primary objective of REFORM-MR is to evaluate the clinical outcomes of the standardized subannular repair in combination with annuloplasty, focusing on the recurrence of FMR (Grade 2 or more) in patients with type IIIb FMR at 2-year follow-up after the surgery (Table 2). Secondary objectives are the identification of echocardiographic predictors of recurrent MR in patients undergoing subannular repair. This includes the investigation of the underlying pathology of mitral valve and the analysis of the common tenting parameters that could serve as potential prognostic biomarkers. In addition, MACCE, mitral valve re-interventions, device therapy for advanced heart failure, mortality, re-hospitalization for heart failure, and QoL of patients with FMR before and after the surgery are assessed.
Table 2
REFORM-MR registry objectives
Primary objective
Freedom from recurrent FMR (> Grade 2) in patients with type IIIb FMR with reduced systolic ventricle function at 2-years follow-up after subannular repair by realignment of papillary muscles combined with annuloplasty
Secondary objectives
Assessment of common tenting parameters (tenting height, coaptation length, tenting area, posterior mitral leaflet and anterior mitral leaflet angles) via detailed echocardiographic examination and their correlation with the following clinical outcomes 6 months, 1 year, and 2 years after subannular repair combined with annuloplasty:
 
  Adverse cardiac events (MACCE)
 
  Mitral valve re-intervention
 
  Device therapy in advanced heart failure (Left ventricular assist device/Heart transplantation)
 
  Cardiac mortality
 
Re-hospitalization due to heart failure
 
QoL assessment of patients with FMR before and after subannular repair using SF-12 Health Survey
 
Development of surgical strategies to improve long-term outcomes in patients with high-grade LV dilatation, including:
 
  Recurrent heart failure
 
  Long-term survival
 
  Ventricular function

Data collection

The clinical outcome data collected are based on the site’s standards of care for MVr. The collected data include medical history, laboratory results and symptoms, TTE, and QoL measures, among others (Table 3). Data are captured by an electronic case report form (eCRF; Software for Trials Europe GmbH, Berlin, Germany) by either a study nurse or physician, and are checked automatically for plausibility and completeness. Digital Imaging and Communication in Medicine (DICOM) files of the echocardiograms are collected for analysis by the Echo Core Laboratory to ensure unbiased and consistent analysis of the echocardiographic data.
Table 3
Data collection schedule
 
Preoperative parameters
Surgery
Discharge
6 months
Year 1
Year 2
Registry exit
Adverse events
Signed informed consent
X
       
Inclusion/exclusion criteria
X
       
Baseline characteristics
X
       
Demographics and vital signs
X
       
Medical historya
X
       
Echo valve pathology
X
       
Laboratory/Symptoms
X
  
X
X
X
  
MRI
X
   
X
X
  
Access (Operative data)
 
X
      
Discharge data
  
X
     
Echocardiogram (TTE)
X
 
X
X
X
X
  
Echo form
  
X
X
X
X
  
6 Minute Walk Test
X
   
X
X
  
QoL questionnaire (SF-12)
X
  
X
X
X
  
Outcome questionsb
   
X
X
X
  
Expiration (death form)
  
X
X
X
X
  
Device and Patient success
  
X
     
Registry exit
      
X
 
Adverse events
   
X
X
X
 
X
MRI magnetic resonance imaging, QoL quality of life, SF-12 short form-12, TTE transthoracic echocardiogram
aIncludes current and previous cardiovascular and non‐cardiovascular conditions
bIncludes occurrence of cardiovascular complications, site complications, and re-interventions since the last visit

Monitoring

Physicians/surgeons and study personnel are required to make themselves familiar with the registry protocol, eCRF, requirements, and procedures. Approximately 20% of sites’ entries are selected at random and monitored after the completion of patient documentation, including follow-up. Source data verification is performed for all patients in these selected centers.

Statistical analysis

Based on the expected recurrence of FMR between 10 and 50%, a sample of 100 patients will arrive at a 95% confidence interval (CI) of ± 8.98% for 30% FMR recurrence. The CI for 20% would be ± 7.84% and ± 5.88% for 10% FMR recurrence.
Statistical analyses are performed for the total study population. Continuous variables are presented as mean ± standard deviation (SD) or as median with interquartile range (IQR), and categorical variables (e.g., gender) are reported as frequencies and percentages. The Kolmogorov–Smirnov test is used to test for normal distribution. Comparisons are performed using Student’s t-test or Mann–Whitney U test for continuous variables and the Chi-Square or Fisher exact test for categorical variables. Linearized rates and actuarial probability statistics may be used where appropriate for adverse event reporting. Kaplan–Meier analyses is performed for survival and safety outcomes. All statistical analyses are performed using IBM SPSS Statistics version 24 (IBM, Armonk, New York). A p-value of < 0.05 is considered statistically significant.

Results

As of May 2021, a total of 97 patients were enrolled across five sites in Germany.

Discussion

Recurrent MR is common in patients undergoing an isolated annuloplasty for FMR, even in initially successful cases [10]. Although isolated annuloplasty is still considered as a gold standard for treating FMR, this procedure only corrects the mitral annulus without addressing the underlying pathophysiological mechanism of FMR. Liel-Cohen et al. initially highlighted the importance of papillary muscle tip-to-annulus distance in promoting mitral leaflet tethering [17]. Therefore, it seems quite logical to combine novel subannular repair manoeuvres with a ring annuloplasty for a pathophysiology-oriented management of FMR patients.

Available data

Previous studies have demonstrated the benefits of adding various subannular manoeuvres to annuloplasty, including a reduced risk of MR recurrence, decreased leaflet tethering, reversed LV remodeling, and improved mid-term cardiac outcomes [1820]. Since type IIIb FMR results from gradually increasing distance between the mitral annular plane and the tips of papillary muscles, applying papillary muscle interventions might prevent or at least delay the recurrence of MR by suppressing further apico-lateral papillary displacement. Data from meta-analyses suggest that a combination of papillary muscle techniques and annuloplasty is associated with significantly lower MR recurrence in FMR with restricted systolic leaflet motion when compared to annuloplasty alone [15, 21]. Fattouch and colleagues reported decreased mitral leaflet tethering and reduced rates of recurrent FMR and adverse cardiac events after additional papillary relocation as compared to an isolated annuloplasty [22]. Recently, Harmel et al. [23] published results of papillary muscle repositioning technique in combination with annuloplasty and similarly found a significantly lower recurrence rate of FMR at 1-year follow-up as well as decreased residual leaflet tenting after papillary muscle relocation vs. annuloplasty alone. Furthermore, papillary muscle relocation/repositioning has been shown to be more effective at preventing MR recurrence than papillary muscle approximation [21].

Need for additional evidence

Despite the growing evidence suggesting that papillary muscles relocation is associated with better postoperative outcomes and longer overall survival, there is still no consensus regarding the most appropriate surgical strategy for subannular repair. Most reported data are from small, single-center, retrospective or observational studies [12, 22, 24]. Therefore, we designed a multicenter single-arm registry to further evaluate the combination of papillary muscle repositioning with annuloplasty for repairing type IIIb FMR. In addition, a better understanding of the tenting parameters and the underlying pathological mechanisms of recurrent MR will enable physicians to determine an individualised surgical strategy.

Critical appraisal of the methodology

The REFORM-MR is a prospective, non-randomized single-arm registry conducted in multiple centres in Germany. The multicenter setting definitely increases the applicability of findings but might limit the generalizability of the results across other countries. Because of the multicentre design, an Echo CoreLab has been established to ensure unbiased and consistent analysis of the collected clinical data. In addition, Echo CoreLab can reduce variability of imaging data and ensure the validity of the results. Based on the recurrence rate of FMR, the sample size of 100 patients was determined and deemed sufficient for an accurate estimate of the predictive variables.

Limitations

This registry is a non-randomized trial and has, therefore, a potential for confounding and bias in the analysis with a limited ability for adjustment. However, systematic data on patients’ outcomes after subannular MVr is scarce. Therefore, a prospective investigation of the preoperative parameters and postoperative outcomes in patients undergoing subannular MVr is valuable and may enable a wider use of this novel surgical approach in the clinical practice.
The lack of control group is another limitation of our study. Given the fact that the key point of this registry was implementation of standardized subannular repair technique in a multicenter setting and, therefore, included proctored cases as well as institutional learning curve, the general consensus was to start with a single-armed prospective registry with the focus on implementation of standardized subannular repair.
Finally, this manuscript is a protocol publication and describes the background and design of REFORM-MR registry only. However, taking into account that this registry represents the first multicenter initiative on a standardized subannular repair in type IIIb MR, we strongly believe that even a protocol paper has an apparent scientific value for the cardiac surgical community. It aims to further stimulate multicenter networking to create a solid evidence basis for pathophysiology-oriented repair in FMR and to encourage ongoing surgical research in this important area.

Conclusion

The ultimate goal of REFORM-RM is to evaluate a standardized, reproducible, and effective papillary muscle relocation technique for type IIIb FMR in a multicenter setting. Thus, the results of this registry will provide supportive evidence of the efficacy of papillary muscle relocation in type IIIb FMR and in-depth information on the impact of tenting parameters on the outcomes of the subannular MVr. Together, these findings will help improve postoperative outcomes of FMR patients, reduce the risk of re-hospitalization, and potentially improve their long-term survival.

Acknowledgements

We acknowledge the support of all participating patients and their physicians.

Declarations

The registry is established in accordance with the Declaration of Helsinki (1964) and was approved by the Ethics Committee of the Hamburg Medical Association (#PV5686) as well as the ethics committees responsible at each center. Patients provided written informed consent prior to the enrolment.
Not applicable.

Competing interests

EG: Received research funding for this registry and compensation for patient documentation and talks and advisory roles from Edwards Lifesciences (Nyon, Switzerland). JP: received compensation for patient documentation. HR: received compensation for patient documentation. JK: received compensation for patient documentation and talks and advisory roles from Edwards Lifesciences (Nyon, Switzerland). TK: received compensation for patient documentation. TO: received compensation for patient documentation. TH: received compensation for patient documentation. MK: received compensation for patient documentation. KV: received compensation for patient documentation. MB: received compensation for patient documentation and talks and advisory roles from Edwards Lifesciences (Nyon, Switzerland). ME: has no conflict to declare. VH: has no conflict to declare. PB: received research funding for this registry and compensation for talks and advisory roles from Edwards Lifesciences (Nyon, Switzerland). VF: received compensation for patient documentation and talks and advisory roles from Edwards Lifesciences (Nyon, Switzerland).
Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://​creativecommons.​org/​licenses/​by/​4.​0/​. The Creative Commons Public Domain Dedication waiver (http://​creativecommons.​org/​publicdomain/​zero/​1.​0/​) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Literatur
1.
Zurück zum Zitat Douedi S, Douedi H. Mitral regurgitation. Treasure Island: StatPearls Publishing; 2021. Douedi S, Douedi H. Mitral regurgitation. Treasure Island: StatPearls Publishing; 2021.
2.
Zurück zum Zitat Pausch J, Harmel E, Sinning C, Reichenspurner H, Girdauskas E. Standardized subannular repair for type IIIb functional mitral regurgitation in a minimally invasive mitral valve surgery setting†. Eur J Cardiothorac Surg. 2019;56(5):968–75.CrossRef Pausch J, Harmel E, Sinning C, Reichenspurner H, Girdauskas E. Standardized subannular repair for type IIIb functional mitral regurgitation in a minimally invasive mitral valve surgery setting†. Eur J Cardiothorac Surg. 2019;56(5):968–75.CrossRef
3.
Zurück zum Zitat Petrus AHJ, Dekkers OM, Tops LF, Timmer E, Klautz RJM, Braun J. Impact of recurrent mitral regurgitation after mitral valve repair for functional mitral regurgitation: long-term analysis of competing outcomes. Eur Heart J. 2019;40(27):2206–14.CrossRef Petrus AHJ, Dekkers OM, Tops LF, Timmer E, Klautz RJM, Braun J. Impact of recurrent mitral regurgitation after mitral valve repair for functional mitral regurgitation: long-term analysis of competing outcomes. Eur Heart J. 2019;40(27):2206–14.CrossRef
4.
Zurück zum Zitat Asgar AW, Mack MJ, Stone GW. Secondary mitral regurgitation in heart failure: pathophysiology, prognosis, and therapeutic considerations. J Am Coll Cardiol. 2015;65(12):1231–48.CrossRef Asgar AW, Mack MJ, Stone GW. Secondary mitral regurgitation in heart failure: pathophysiology, prognosis, and therapeutic considerations. J Am Coll Cardiol. 2015;65(12):1231–48.CrossRef
5.
Zurück zum Zitat Echarte-Morales J, Minguito-Carazo C, Benito-González T, Estévez-Loureiro R, Garrote-Coloma C, Prado APd, et al. Percutaneous treatment of mitral regurgitation recurrence after mitral valve surgery. Vessel Plus. 2021;5:54. Echarte-Morales J, Minguito-Carazo C, Benito-González T, Estévez-Loureiro R, Garrote-Coloma C, Prado APd, et al. Percutaneous treatment of mitral regurgitation recurrence after mitral valve surgery. Vessel Plus. 2021;5:54.
6.
Zurück zum Zitat Coats AJS, Anker SD, Baumbach A, Alfieri O, von Bardeleben RS, Bauersachs J, et al. The management of secondary mitral regurgitation in patients with heart failure: a joint position statement from the Heart Failure Association (HFA), European Association of Cardiovascular Imaging (EACVI), European Heart Rhythm Association (EHRA), and European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the ESC. Eur Heart J. 2021;42(13):1254–69.CrossRef Coats AJS, Anker SD, Baumbach A, Alfieri O, von Bardeleben RS, Bauersachs J, et al. The management of secondary mitral regurgitation in patients with heart failure: a joint position statement from the Heart Failure Association (HFA), European Association of Cardiovascular Imaging (EACVI), European Heart Rhythm Association (EHRA), and European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the ESC. Eur Heart J. 2021;42(13):1254–69.CrossRef
7.
Zurück zum Zitat Acker MA, Parides MK, Perrault LP, Moskowitz AJ, Gelijns AC, Voisine P, et al. Mitral-valve repair versus replacement for severe ischemic mitral regurgitation. N Engl J Med. 2014;370(1):23–32.CrossRef Acker MA, Parides MK, Perrault LP, Moskowitz AJ, Gelijns AC, Voisine P, et al. Mitral-valve repair versus replacement for severe ischemic mitral regurgitation. N Engl J Med. 2014;370(1):23–32.CrossRef
8.
Zurück zum Zitat Ciarka A, Braun J, Delgado V, Versteegh M, Boersma E, Klautz R, et al. Predictors of mitral regurgitation recurrence in patients with heart failure undergoing mitral valve annuloplasty. Am J Cardiol. 2010;106(3):395–401.CrossRef Ciarka A, Braun J, Delgado V, Versteegh M, Boersma E, Klautz R, et al. Predictors of mitral regurgitation recurrence in patients with heart failure undergoing mitral valve annuloplasty. Am J Cardiol. 2010;106(3):395–401.CrossRef
9.
Zurück zum Zitat Bax JJ, Braun J, Somer ST, Klautz R, Holman ER, Versteegh MIM, et al. Restrictive annuloplasty and coronary revascularization in ischemic mitral regurgitation results in reverse left ventricular remodeling. Circulation. 2004;110(11 Suppl 1):II103–8. Bax JJ, Braun J, Somer ST, Klautz R, Holman ER, Versteegh MIM, et al. Restrictive annuloplasty and coronary revascularization in ischemic mitral regurgitation results in reverse left ventricular remodeling. Circulation. 2004;110(11 Suppl 1):II103–8.
10.
Zurück zum Zitat Hung J, Papakostas L, Tahta SA, Hardy BG, Bollen BA, Duran CM, et al. Mechanism of recurrent ischemic mitral regurgitation after annuloplasty: continued LV remodeling as a moving target. Circulation. 2004;110(11 Suppl 1):II85-90. Hung J, Papakostas L, Tahta SA, Hardy BG, Bollen BA, Duran CM, et al. Mechanism of recurrent ischemic mitral regurgitation after annuloplasty: continued LV remodeling as a moving target. Circulation. 2004;110(11 Suppl 1):II85-90.
11.
Zurück zum Zitat Borger MA, Murphy PM, Alam A, Fazel S, Maganti M, Armstrong S, et al. Initial results of the chordal-cutting operation for ischemic mitral regurgitation. J Thorac Cardiovasc Surg. 2007;133(6):1483-92.e1.CrossRef Borger MA, Murphy PM, Alam A, Fazel S, Maganti M, Armstrong S, et al. Initial results of the chordal-cutting operation for ischemic mitral regurgitation. J Thorac Cardiovasc Surg. 2007;133(6):1483-92.e1.CrossRef
12.
Zurück zum Zitat Fattouch K, Castrovinci S, Murana G, Dioguardi P, Guccione F, Nasso G, et al. Papillary muscle relocation and mitral annuloplasty in ischemic mitral valve regurgitation: midterm results. J Thorac Cardiovasc Surg. 2014;148(5):1947–50.CrossRef Fattouch K, Castrovinci S, Murana G, Dioguardi P, Guccione F, Nasso G, et al. Papillary muscle relocation and mitral annuloplasty in ischemic mitral valve regurgitation: midterm results. J Thorac Cardiovasc Surg. 2014;148(5):1947–50.CrossRef
13.
Zurück zum Zitat Rabbah J-PM, Siefert AW, Bolling SF, Yoganathan AP. Mitral valve annuloplasty and anterior leaflet augmentation for functional ischemic mitral regurgitation: quantitative comparison of coaptation and subvalvular tethering. J Thorac Cardiovasc Surg. 2014;148(4):1688–93.CrossRef Rabbah J-PM, Siefert AW, Bolling SF, Yoganathan AP. Mitral valve annuloplasty and anterior leaflet augmentation for functional ischemic mitral regurgitation: quantitative comparison of coaptation and subvalvular tethering. J Thorac Cardiovasc Surg. 2014;148(4):1688–93.CrossRef
14.
Zurück zum Zitat Robb JD, Minakawa M, Koomalsingh KJ, Shuto T, Jassar AS, Ratcliffe SJ, et al. Posterior leaflet augmentation improves leaflet tethering in repair of ischemic mitral regurgitation☆,☆☆. Eur J Cardiothorac Surg. 2011;40(6):1501–7. Robb JD, Minakawa M, Koomalsingh KJ, Shuto T, Jassar AS, Ratcliffe SJ, et al. Posterior leaflet augmentation improves leaflet tethering in repair of ischemic mitral regurgitation☆,☆☆. Eur J Cardiothorac Surg. 2011;40(6):1501–7.
15.
Zurück zum Zitat Harmel EK, Reichenspurner H, Girdauskas E. Subannular reconstruction in secondary mitral regurgitation: a meta-analysis. Heart. 2018;104(21):1783–90.CrossRef Harmel EK, Reichenspurner H, Girdauskas E. Subannular reconstruction in secondary mitral regurgitation: a meta-analysis. Heart. 2018;104(21):1783–90.CrossRef
16.
Zurück zum Zitat Pausch J, Girdauskas E, Conradi L, Reichenspurner H. Secondary mitral regurgitation repair techniques and outcomes: subannular repair techniques in secondary mitral regurgitation type IIIb. JTCVS Tech. 2021;10:92–7.CrossRef Pausch J, Girdauskas E, Conradi L, Reichenspurner H. Secondary mitral regurgitation repair techniques and outcomes: subannular repair techniques in secondary mitral regurgitation type IIIb. JTCVS Tech. 2021;10:92–7.CrossRef
17.
Zurück zum Zitat Liel-Cohen N, Guerrero JL, Otsuji Y, Handschumacher MD, Rudski LG, Hunziker PR, et al. Design of a new surgical approach for ventricular remodeling to relieve ischemic mitral regurgitation: insights from 3-dimensional echocardiography. Circulation. 2000;101(23):2756–63.CrossRef Liel-Cohen N, Guerrero JL, Otsuji Y, Handschumacher MD, Rudski LG, Hunziker PR, et al. Design of a new surgical approach for ventricular remodeling to relieve ischemic mitral regurgitation: insights from 3-dimensional echocardiography. Circulation. 2000;101(23):2756–63.CrossRef
18.
Zurück zum Zitat Mihos CG, Larrauri-Reyes M, Santana O. A meta-analysis of ring annuloplasty versus combined ring annuloplasty and subvalvular repair for moderate-to-severe functional mitral regurgitation. J Card Surg. 2016;31(1):31–7.CrossRef Mihos CG, Larrauri-Reyes M, Santana O. A meta-analysis of ring annuloplasty versus combined ring annuloplasty and subvalvular repair for moderate-to-severe functional mitral regurgitation. J Card Surg. 2016;31(1):31–7.CrossRef
19.
Zurück zum Zitat Nappi F, Lusini M, Spadaccio C, Nenna A, Covino E, Acar C, et al. Papillary muscle approximation versus restrictive annuloplasty alone for severe ischemic mitral regurgitation. J Am Coll Cardiol. 2016;67(20):2334–46.CrossRef Nappi F, Lusini M, Spadaccio C, Nenna A, Covino E, Acar C, et al. Papillary muscle approximation versus restrictive annuloplasty alone for severe ischemic mitral regurgitation. J Am Coll Cardiol. 2016;67(20):2334–46.CrossRef
20.
Zurück zum Zitat Santana O, Solenkova NV, Pineda AM, Mihos CG, Lamelas J. Minimally invasive papillary muscle sling placement during mitral valve repair in patients with functional mitral regurgitation. J Thorac Cardiovasc Surg. 2014;147(1):496–9.CrossRef Santana O, Solenkova NV, Pineda AM, Mihos CG, Lamelas J. Minimally invasive papillary muscle sling placement during mitral valve repair in patients with functional mitral regurgitation. J Thorac Cardiovasc Surg. 2014;147(1):496–9.CrossRef
21.
Zurück zum Zitat Micali LR, Qadrouh MN, Parise O, Parise G, Matteucci F, de Jong M, et al. Papillary muscle intervention vs mitral ring annuloplasty in ischemic mitral regurgitation. J Card Surg. 2020;35(3):645–53.CrossRef Micali LR, Qadrouh MN, Parise O, Parise G, Matteucci F, de Jong M, et al. Papillary muscle intervention vs mitral ring annuloplasty in ischemic mitral regurgitation. J Card Surg. 2020;35(3):645–53.CrossRef
22.
Zurück zum Zitat Fattouch K, Lancellotti P, Castrovinci S, Murana G, Sampognaro R, Corrado E, et al. Papillary muscle relocation in conjunction with valve annuloplasty improve repair results in severe ischemic mitral regurgitation. J Thorac Cardiovasc Surg. 2012;143(6):1352–5.CrossRef Fattouch K, Lancellotti P, Castrovinci S, Murana G, Sampognaro R, Corrado E, et al. Papillary muscle relocation in conjunction with valve annuloplasty improve repair results in severe ischemic mitral regurgitation. J Thorac Cardiovasc Surg. 2012;143(6):1352–5.CrossRef
23.
Zurück zum Zitat Harmel E, Pausch J, Gross T, Petersen J, Sinning C, Kubitz J, et al. Standardized subannular repair improves outcomes in Type IIIb functional mitral regurgitation. Ann Thorac Surg. 2019;108(6):1783–92.CrossRef Harmel E, Pausch J, Gross T, Petersen J, Sinning C, Kubitz J, et al. Standardized subannular repair improves outcomes in Type IIIb functional mitral regurgitation. Ann Thorac Surg. 2019;108(6):1783–92.CrossRef
24.
Zurück zum Zitat Li B, Sun H. Subannular repair for moderate to severe ischemic mitral regurgitation: Still a long way to go: Authors’ reply. Cardiol J. 2020;27(2):223–4.CrossRef Li B, Sun H. Subannular repair for moderate to severe ischemic mitral regurgitation: Still a long way to go: Authors’ reply. Cardiol J. 2020;27(2):223–4.CrossRef
Metadaten
Titel
Subannular repair for functional mitral regurgitation with reduced systolic ventricle function: rationale and design of REFORM-MR registry
verfasst von
Evaldas Girdauskas
Jonas Pausch
Hermann Reichenspurner
Jörg Kempfert
Thomas Kuntze
Tamer Owais
Tomas Holubec
Markus Krane
Keti Vitanova
Michael Borger
Matthias Eden
Violetta Hachaturyan
Peter Bramlage
Volkmar Falk
Publikationsdatum
01.12.2022
Verlag
BioMed Central
Erschienen in
Journal of Cardiothoracic Surgery / Ausgabe 1/2022
Elektronische ISSN: 1749-8090
DOI
https://doi.org/10.1186/s13019-022-02045-9

Weitere Artikel der Ausgabe 1/2022

Journal of Cardiothoracic Surgery 1/2022 Zur Ausgabe

Mehr Frauen im OP – weniger postoperative Komplikationen

21.05.2024 Allgemeine Chirurgie Nachrichten

Ein Frauenanteil von mindestens einem Drittel im ärztlichen Op.-Team war in einer großen retrospektiven Studie aus Kanada mit einer signifikanten Reduktion der postoperativen Morbidität assoziiert.

Real-World-Daten sprechen eher für Dupilumab als für Op.

14.05.2024 Rhinosinusitis Nachrichten

Zur Behandlung schwerer Formen der chronischen Rhinosinusitis mit Nasenpolypen (CRSwNP) stehen seit Kurzem verschiedene Behandlungsmethoden zur Verfügung, darunter Biologika, wie Dupilumab, und die endoskopische Sinuschirurgie (ESS). Beim Vergleich der beiden Therapieoptionen war Dupilumab leicht im Vorteil.

Vorsicht, erhöhte Blutungsgefahr nach PCI!

10.05.2024 Koronare Herzerkrankung Nachrichten

Nach PCI besteht ein erhöhtes Blutungsrisiko, wenn die Behandelten eine verminderte linksventrikuläre Ejektionsfraktion aufweisen. Das Risiko ist umso höher, je stärker die Pumpfunktion eingeschränkt ist.

Darf man die Behandlung eines Neonazis ablehnen?

08.05.2024 Gesellschaft Nachrichten

In einer Leseranfrage in der Zeitschrift Journal of the American Academy of Dermatology möchte ein anonymer Dermatologe bzw. eine anonyme Dermatologin wissen, ob er oder sie einen Patienten behandeln muss, der eine rassistische Tätowierung trägt.

Update Chirurgie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.

S3-Leitlinie „Diagnostik und Therapie des Karpaltunnelsyndroms“

Karpaltunnelsyndrom BDC Leitlinien Webinare
CME: 2 Punkte

Das Karpaltunnelsyndrom ist die häufigste Kompressionsneuropathie peripherer Nerven. Obwohl die Anamnese mit dem nächtlichen Einschlafen der Hand (Brachialgia parästhetica nocturna) sehr typisch ist, ist eine klinisch-neurologische Untersuchung und Elektroneurografie in manchen Fällen auch eine Neurosonografie erforderlich. Im Anfangsstadium sind konservative Maßnahmen (Handgelenksschiene, Ergotherapie) empfehlenswert. Bei nicht Ansprechen der konservativen Therapie oder Auftreten von neurologischen Ausfällen ist eine Dekompression des N. medianus am Karpaltunnel indiziert.

Prof. Dr. med. Gregor Antoniadis
Berufsverband der Deutschen Chirurgie e.V.

S2e-Leitlinie „Distale Radiusfraktur“

Radiusfraktur BDC Leitlinien Webinare
CME: 2 Punkte

Das Webinar beschäftigt sich mit Fragen und Antworten zu Diagnostik und Klassifikation sowie Möglichkeiten des Ausschlusses von Zusatzverletzungen. Die Referenten erläutern, welche Frakturen konservativ behandelt werden können und wie. Das Webinar beantwortet die Frage nach aktuellen operativen Therapiekonzepten: Welcher Zugang, welches Osteosynthesematerial? Auf was muss bei der Nachbehandlung der distalen Radiusfraktur geachtet werden?

PD Dr. med. Oliver Pieske
Dr. med. Benjamin Meyknecht
Berufsverband der Deutschen Chirurgie e.V.

S1-Leitlinie „Empfehlungen zur Therapie der akuten Appendizitis bei Erwachsenen“

Appendizitis BDC Leitlinien Webinare
CME: 2 Punkte

Inhalte des Webinars zur S1-Leitlinie „Empfehlungen zur Therapie der akuten Appendizitis bei Erwachsenen“ sind die Darstellung des Projektes und des Erstellungswegs zur S1-Leitlinie, die Erläuterung der klinischen Relevanz der Klassifikation EAES 2015, die wissenschaftliche Begründung der wichtigsten Empfehlungen und die Darstellung stadiengerechter Therapieoptionen.

Dr. med. Mihailo Andric
Berufsverband der Deutschen Chirurgie e.V.