Remodelling and Improved Hemodynamics
TCT 2022 Poster
Goldberg S et al.
Prospective trials of the Carillon Mitral Contour System have shown effective hemodynamic and clinical improvement in patients with heart failure and functional mitral regurgitation (FMR) including beneficial left ventricular and left atrial remodeling.
The CINCH registry is a multi-center, real-world study of patients treated with the Carillon device as standard of care. It is intended to enroll up to 250 patients in up to 40 centers in Germany.
The poster presented shows an interim analysis of 101 patients with up to 5 years follow-up data, including mortality, device related safety, change in NYHA class and rate of heart failure hospitalizations.
Witte K et al.
Although any degree of secondary mitral regurgitation (SMR) is known to further complicate heart failure symptoms and mortality, a treatment paradigm for patients with mild and moderate SMR is lacking. The recent publication on Carillon in the European Journal of Heart Failure – Treating symptoms and reversing remodelling: clinical and echocardiographic 1-year outcomes with percutaneous mitral annuloplasty for mild to moderate secondary mitral regurgitation – was particularly enlightening.
The purpose of the authors’ investigation was to determine the effects of percutaneous mitral annuloplasty on symptoms, 6-minute walk distance, and left ventricular (LV) structure and function in patients with mild or moderate SMR in heart failure with reduced ejection fraction. They examined a total of 68 patients from all Carillon trials who had mild and moderate SMR in a retrospective study of one-year outcomes. The findings were very encouraging:
- Mean 6-minute walk test distance increased by 34 m (95% CI 12 to 57; P < 0.01)
- Mean KCCQ scores increased from baseline by 10 units [95% confidence interval (CI) 3 to 17; P < 0.01]
- SMR grade improved in 25% of patients and was maintained in 58% of patients with changes in mean regurgitant volume of −7 mL (95% CI −11 to −3; P < 0.001), vena contracta −0.11 cm (95% CI −0.20 to −0.02; P < 0.05), and effective regurgitant orifice area −0.03 cm2 (95% CI −0.06 to −0.01; P < 0.05)
- New York Heart Association class status was maintained (48%) or improved (46%) in the vast majority of patients
- Survival over one year was 89% and freedom from HF hospitalization was 73%
The authors conclude: “Among patients with symptomatic HF and mild or moderate SMR on guideline-directed medical therapy, percutaneous mitral annuloplasty [i.e., the Carillon therapy] was associated with improvements in symptoms, SMR, a stabilization of LV structure and function, and high survival rates.”
JACC: Heart Failure
Anker et al.
Although COAPT was successful, MITRA.fr was not. The prevailing theories as to the difference in the trials is the amount of left ventricular dysfunction in enrolled patients. This is a pooled analysis of patients with functional MR and severe LV enlargement (LV end-diastolic diameter > 65 mm) who were treated with GDMT and the Carillon device vs GDMT alone – i.e., MITRA.fr patients. Key outcomes of this analysis were changes over 1 year of follow-up in mitral valve and LV echocardiographic parameters, functional outcome, quality of life, mortality, and heart failure hospitalization (HFH).
- A total of 95 patients (67 Carillon group; 28 GDMT group) with severe LV enlargement were included.
- In the Carillon group, all mitral valve and LV morphology parameters were significantly improved at 1 year.
- Regurgitant volume decreased by 12 ml (p<0.001)
- MR grade decreased by 0.6 units (p<0.001)
- LV end-diastolic volume decreased by 25 cc (p=0.005)
- LV end-systolic volume decreased by 21 cc (p=0.01)
- Significant functional improvement differences were also noted between the Carillon group vs. GDMT group:
- Improvement of KCCQ score (15±4 vs 6±6; p=0.03)
- Incidence of HFH was 29.9% vs. 50.0% and the cumulative rate of HFH was 0.43 vs. 0.75 (p<0.001)
In conclusion, “In patients with functional MR and severe LV enlargement, the Carillon device improved mitral valve function, LV morphology, and functional outcome compared to patients receiving GDMT only. Preoperative LV dimension should not be a limiting factor when evaluating patient eligibility or anticipated response to therapy with the Carillon device.”
Lipiecki et al.
Indirect Annuloplasty of the Mitral Valve The Carillon Mitral Contour System*
This article addresses the millions of heart failure patients worldwide that have a significantly increased risk of mortality because of functional mitral regurgitation (FMR). The article goes on to discuss the extensive clinical experience available for the Carillon device in treating FMR, advantages of the Carillon approach over alternative therapies, and highlights numerous patient groups that could benefit from treatment with the Carillon device. The authors conclude:
- The results of studies conducted to date suggest that FMR treatment with the Carillon device is both safe and effective in reducing both mitral regurgitation and left ventricular dysfunction.
- The short procedure time and the easy deployment of the device are certainly an advantage over other techniques available on the market.
- The prospective CARILLON US trial, currently underway, evaluates the effectiveness of the Carillon device on morbidity and mortality, and should validate the Carillon Mitral Contour System as a first-line interventional therapy.
*Original article published in the March 2021 edition of CATH’LAB. The article summary above has been translated from the original French publication with the assistance of machine translation (DeepL).
ESC Heart Failure
Khan et al.
An individual patient data meta‐analysis was conducted from 3 prospective studies that enrolled heart failure patients with reduced ejection fraction and functional mitral regurgitation (FMR) implanted with the Carillon Mitral Contour System. The main outcomes assessed were changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Summary Scores (KCCQ-OSS), six-minute walk test (6MWT) distance and New York Heart Association (NYHA) classification at month 1 and 12 post device implantation.
- Among 139 patients included in the analysis, Carillon device significantly improved the 6MWT distance (63.0m; 95%CI 18.8-107.2, p=0.0056) and KCCQ-OSS score (15.1; 95%CI 5.6-24.7, p=0.0022) at 1 month from baseline. These benefits were sustained at 12 months (64.1m; 95%CI 13.2-115.0, p=0.0141for 6MWT distance, and 12.3; 95%CI 4.7-19.8, p=0.0019 for KCCQ-OSS score).
- More than 50% of the patients had improvements in KCCQ-OSS by ≥ 5 (60.4%; 95%CI 47.4-72.1) and 10 points (50.5%; 95%CI 34.9-66.0) at 12 months.
- Almost half of the patients experienced a ≥1 class improvement in NYHA class after implantation of the device at 1 month (67.9%; 95%CI 37.3-88.3) and at 12 months (48.8%; 95%CI 31.8-66.2).
- Results remained similar for KCCQ-OSS, 6MWT distance and NYHA classification when only patients with grade 3 or 4 mitral regurgitation were analyzed.
The Carillon Mitral Contour System significantly improved patient reported quality of life outcomes in heart failure patients with functional mitral regurgitation. Quality of life improvement in patients who were treated with the Carillon device was similar or better than other recently reported heart failure trials.
ESC Heart Failure
Khan et al.
Patients with heart failure often have impaired physical function and reduced quality of life (QoL). Therefore, improving QoL by a minimum clinically important difference (MCID) is an important measure of the effectiveness of heart failure management.
This recently published paper is a rigorous analysis of the REDUCE FMR trial, focusing on the intended patient population based on core-lab adjudication*. It shows convincing 12-month results for the only sham-controlled randomized blinded study ever conducted in heart valve treatment.
- A substantially higher number of patients achieved MCID for all patient‐centered outcomes with the Carillon device compared with the sham procedure.
- Improvement for the 6 minute walk test (6MWT)
- Improvement in NYHA class
- Improvement in QoL, based on the KCCQ survey
- Decrease in heart failure hospitalization
- In particular, the proportion of patients who achieved MCID improvement in the 6MWT (≥30 m increase) at 1 year of follow‐up from baseline was significantly higher in the Carillon device group compared with the sham group (59% vs. 23%, respectively; P = 0.029), even though REDUCE-FMR was only powered to detect the mechanistic endpoint of mitral regurgitation reduction.
- The number needed to treat (NNT) for a ≥30 m increase in 6MWT distance with the Carillon device was 2.8, and the NNT for a ≥20 m increase in 6MWT distance was 3.6.
- Additionally, all other clinical improvements of patients receiving the device relative to control are also encouraging and support the continued utilization of the Carillon device.
The authors conclude: “The patient population in this subgroup of those enrolled in REDUCE‐FMR (EROA, 0.31 cm2; LVDD, 66 mm) resembles that of the MITRA‐FR trial and is more generalizable to patients with HF and moderate to severe FMR. However, unlike the MITRA‐FR trial, our results show a trend towards improvement in patient‐centred outcomes with the Carillion device. In fact, the low NNT for all patient‐centred outcomes suggests that the Carillon device is likely to provide benefit in a large proportion of patients with FMR, rather than just a small subset. Furthermore, unlike the COAPT and MITRA‐FR trials, the REDUCE‐FMR trial used a sham procedure in the control group, which increases the reliability of its results by minimizing placebo and nocebo effects.”
*The intended patient population analysis was conducted to assess functional outcomes of patients with heart failure with reduced ejection fraction and moderate to severe (Grades 2+ to 4+) functional mitral regurgitation (FMR) treated with the Carillon device or control. Since 29.7% of patients were enrolled with only mild core-lab adjudicated MR grade 1+, this analysis focused on the intended patient population of the REDUCE FMR Trial with inclusion criteria of MR grades 2+ to 4+.
JACC: Cardiovascular Interventions
Rottländer et al.
Echographic outcomes of patients with atrial derived FMR (aFMR) and heart failure with preserved ejection fraction (HFpEF) were compared to patients with ventricular derived FMR (vFMR) and heart failure with reduced ejection fraction (HFrEF) after percutaneous mitral valve repair with the Carillon Mitral Contour System.
- Patients with aFMR showed similar reductions in mitral annulus diameter and concomitant reduction in regurgitant volume through 3 months compared to those with vFMR.
- Significant reduction in MR as assessed by vena contracta, effective regurgitant volume as well as MR was seen as soon as 3 months after procedure in both groups.
- Similarly, after 3 months the proportion of patients with NYHA class III or IV was reduced from 92.8% to 42.8% which was maintained throughout 12 month follow-up.
The Carillon device is feasible in HFpEF patients with aFMR and is associated with significant reductions in MR.
ESC Heart Failure
Giallauria et al.
An individual patient data meta‐analysis was conducted from 3 prospective studies that enrolled 209 heart failure patients with reduced ejection fraction and functional mitral regurgitation (FMR). Patients implanted with the Carillon Mitral Contour System or control were assessed for 12-month outcomes relating to mitral regurgitation severity, left ventricular (LV) remodeling, functional status, and heart failure‐related hospitalization.
- Patients implanted with the device showed significantly improved hemodynamics, MR severity (regurgitant volume and MR grade), left ventricular volume (LVEDV) and left atrial volume (LAV), as compared to those patients who did not receive a device at 12 months.
- Improvement of symptoms as assessed by change in NYHA class also significantly favored device implantation vs control (p<0.00001) with 69.9% (51/73) of implanted patients with baseline class III or IV improving by at least one class at 12 months.
- Similarly, the rate of hospitalizations due to heart failure (HFH) was significantly reduced in implanted patients (45.3% vs 64%, p=0.04).
- Sensitivity analysis performed on subjects with more severe MR (MR grade 3+/4+) at baseline supported the overall cohort in terms of hemodynamic improvement and maintained a significant improvement in HFH (43.9% vs 82.9%, p=0.04).
In conclusion, this comprehensive meta‐analysis of individual patient data has shown that the CARILLON device provides statistically significant and clinically meaningful benefits in LV volumes, NYHA functional class and indexes of mitral valve performance, along with a reduction in the rate of subsequent HFH.
ESC Heart Failure
Mitja Lainscak and Michael Böhm
In this editorial Dr. Lainscak and Professor Böhm discuss the optimal management strategy for patients with Functional Mitral Regurgitation. There is a need in the therapeutic spectrum for additional therapies that are safe and can be deployed as an early intervention to reduce the need for repeated hospitalizations. The data presented by Gialluria et al. supports the use of the Carillon Mitral Contour System to achieve this goal. Owing to less invasive approaches, favourable effects on left ventricular volumes, and possibility of step‐wise upgrade with other interventions, Carillon could be considered early in the patient trajectory for a timely and effective management of heart failure patients with reduced ejection fraction and functional mitral regurgitation.
ESC Heart Failure
- 30 patients with symptomatic moderate or severe SMR [FMR] were assessed for the acute effects of Carillon therapy by advanced echocardiography 1 day prior to procedure and at discharge.
- Treatment of SMR [FMR] with the Carillon device leads to acute reduction of MR severity in 83% of patients after the procedure.
- Both PISA based measurements of regurgitant volume as well as measurements derived from regurgitant fraction were significantly improved (p<0.05) after the procedure.
- Effective [forward] stroke volume was significantly improved (p<0.001) and ejection fraction was non-significantly improved (p = 0.06) immediately after the intervention.
ESC Heart Failure
- 37 patients implanted with the Carillon device were included in this retrospective, single-center study.
- First study to show significant reduction in annular diameter in both anterior-posterior and anterolateral-posteromedial aspects (p<0.001) after any transcatheter mitral valve repair therapy.
- Left atrial volume significantly reduced (p<0.02) at 30 days follow up and maintained through 1 year.
JACC: Heart Failure
The REDUCE FMR study was the first double-blinded trial of a percutaneous heart valve therapy, achieved its primary endpoint, and demonstrated favorable reverse LV remodeling. A median 22% reduction in regurgitant volume was demonstrated, as assessed by a blinded, independent echo core lab. The results of The REDUCE FMR study are consistent with the prior Carillon device studies.
REDUCE FMR was the first ever double-blinded, randomized, parallel, sham-controlled RCT of a percutaneous heart valve therapy. The objective was to assess the safety and effectiveness of the Carillon Mitral Contour System for treatment of secondary (functional) mitral regurgitation (FMR) associated with heart failure. Key eligibility criteria were similar to the prior trials of the Carillon system including NYHA class II-IV, MR grade 2+ to 4+, LVEDD >55mm and an ejection fraction <50%, despite the use of stable guideline-directed medical therapy. The primary endpoint was change in regurgitant volume (RV) at 1 year by intention-to-treat analysis. Being double-blind, the study was of the highest scientific rigor – patients and assessors were blinded throughout follow-up and the independent echo core lab not only was blinded to treatment and the timing of the images but also read the images in random order.
In total, 120 patients were randomly allocated to treatment (87) or the sham-control (33) arm at 31 sites in Europe, Australia and New Zealand.
Echocardiographic evaluation was performed at the site prior to enrollment, and 35 patients (29.2%) were later judged by the echo core laboratory to have had MR 1+ at baseline. In 14 (16%) of those allocated to treatment, no device was implanted, due most commonly to coronary impingement (n=8) which resolved following device removal in all cases. The average device implant time was 64.2±34.8 minutes and total procedure time averaged 102.7±54.9 minutes. Freedom from device-related major adverse events (MAE) was 98.9%, with no device embolizations, device fractures, cardiac perforations or intra-procedural ischemic events. There were two deaths within 30 days, both in implanted patients attributed to progressive cardio-renal deterioration. The incidence of MAE at 1 year was not statistically different between the treatment and control groups (16.1% in treatment group vs. 18.2% in control group).
The primary endpoint was met with a statistically significant reduction in mitral RV in the treatment group as compared to the control group (decrease of 7.1 mL/beat vs. an increase of 3.3 mL/beat, p=0.049). A secondary analysis of patients with more severe FMR (MR grade ≥3+) demonstrated a similar pattern of changes. Patients in the treatment group (n=15) experienced a reduction in mitral RV of 12.8 mL/beat whereas patients in the control group (n=8) experienced an increase of 0.6 mL/beat (p=0.14). In addition to improvements in RV, favorable reverse LV remodeling was demonstrated, with a significant reduction in LV volumes in patients receiving the device vs. the control group.
Patients in the treatment group also experienced a significant improvement in 6-minute walk distance at 12 months compared with their baseline (p=0.002), whereas patients allocated to the control group did not (p=0.29). Likewise, the treatment group had a significant improvement in NYHA class at 12 months compared with baseline (p=0.002) whereas patients allocated to the control group did not (p=0.75).
With REDUCE FMR, the Carillon system became the first TMVr therapy to demonstrate significant favorable reverse LV remodeling at 1 year and significant reduction in RV in a blinded, randomized, sham-controlled trial.
J. Invasive Cardiology
This analysis showed that Carillon addresses FMR and, in as little as one-month, successful implantation results in left ventricular reverse remodelling and increased systolic performance. Mitral tenting area is an important baseline parameter in predicting treatment efficacy with Carillon.
- 35 patients were enrolled and 22 were successfully implanted with the Carillon device. Some patients were not implanted due to coronary sinus size (n=3), impaired access (n=2), compromised coronary flow (n=4), or insufficient mitral regurgitation reduction (n=4).
- At one-month follow-up, statistically significant reductions in the following parameters were observed: anteroposterior (AP) diameter, regurgitant volume (RV), vena contracta (VC), effective regurgitant orifice area (EROA), proximal isovelocity surface area (PISA), mitral tenting area, mitral tethering, and mean diastolic interpapillary distance.
- Patients with increased left atrial diameters saw greater improvement in ejection fraction, following implantation.
The TITAN II study achieved its endpoint and showed significant improvements in echo parameters and patient function.
TITAN II was a single-arm study designed to assess the safety and efficacy of an updated version of the Carillon system. Inclusion and exclusion criteria were similar to those in TITAN. Patients had symptomatic congestive heart failure (NYHA class ≥2), MR grade 2+ to 4+, a dilated LV (LVEDD >55 mm) and an ejection fraction <40%. Quantitative assessments of MR were performed by an independent core echo laboratory, and MAE were reviewed by an independent data and safety monitoring board. In total, 36 patients were enrolled; 30 received a permanent implant.
J. Invasive Cardiology
This study showed that potential coronary artery compromise can be managed safely and effectively in all patients with 95% successfully implanted.
- 17 patients were implanted with the Carillon device in a prospective, single-center, non-randomized study.
- Patients experienced a mean one grade reduction of MR acutely (2.8 to 1.9, p<0.005) with an additional improvement at 3 months (1.5, p<0.005).
- In 41.2% of patients an acute reduction of coronary artery flow was detected intraoperatively and in all except one patient this could be easily managed such that the patients successfully received the implant.
Catheterization and Cardiovascular Interventions
In patients with severe heart failure and mitral regurgitation, Carillon can be successfully used as a first line medical device intervention.
- Case report of a NYHA class IV patient who presented with severe dyspnea progressing to orthopnea and paroxysmal nocturnal dyspnea. He was found to have severe functional mitral regurgitation Grade 4 and severe left ventricle systolic dysfunction. Surgical mitral intervention was not considered suitable and percutaneous mitral annuloplasty was performed with Carillon Mitral Contour System.
- From baseline to 6-months following implantation of Carillon the patient experienced a 70% reduction in vena contracta (0.25cm vs. 0.84cm), 90% reduction in regurgitant volume (29ml vs. 291ml). MR Grade was reduced from a grade 4 to grade 2 and NYHA class improved from IV to I.
- Remodelling of the left ventricle was observed and resulted in an absolute improvement in ejection fraction of 30% (from 20% to 50%).
- The patient’s symptoms improved so significantly that he was no longer considered an immediate candidate for CRT.
European Journal of Heart Failure
The TITAN study met its endpoint and showed the Carillon device can significantly and safely reduce FMR severity in heart failure patients, resulting in significant favorable reverse LV remodeling over 12 months and improved measures of clinical outcomes over 24 months.
The TITAN study was a prospective, non-randomized multi-center European study. The objective of the study was to determine if the Carillon device could safely and effectively reduce FMR and yield a durable long-term clinical benefit. Follow-up included typical clinical and echo assessments through 1 year and implanted patients had an additional clinical follow-up assessment at 2 years. The study was rigorously conducted with oversight by independent parties including an echo core lab, clinical events committee, and a data and safety monitoring board. Key inclusion criteria included MR grade 2+ to 4+, NYHA Class II-IV and LVEF <40%.
Of the 53 patients enrolled in the study, 36 underwent permanent implant of the device. In 17 patients, the device was recaptured (due to transient coronary impingement (n=8) or <1 grade FMR reduction (n=9). These non-implant patients were followed as a comparator group.
Kardiol Pol 2011; 69, 3: 228-233
Carillon increased functional capacity and improved echocardiographic parameters in FMR patients.
- This study enrolled 14 consecutive patients who underwent Carillon implantation.
- Echocardiographic parameters, 6MWD, Naughton treadmill exercise test, NYHA class and QOL were assessed at baseline and after one month.
- All measurements demonstrated statistically significant improvement at one month from baseline.
- Echocardiographic MR parameters were observed immediately after the procedure and during the one month follow up; these parameters included vena contracta (0.36cm after procedure and 0.31cm at one month vs. 0.65cm at baseline, both p<0.001) and effective regurgitant orifice area (0.18cm2 after procedure and 0.20cm2 at one month vs. 0.28cm2 at baseline, p<0.05 and p<0.005, respectively).
- One month after the procedure the 6MWT (25%, p<0.001), Naughton treadmill exercise test (45.0%, p<0.005) and NYHA classifications (34.1%, p<0.005) were significantly improved.
Kardiol Pol. 2010.
Carillon improved echocardiographic parameters in functional mitral regurgitation patients.
- In this study, nine patients were enrolled and successfully implanted with the Carillon device.
- One-month post-implant, vena contracta, the ratio of the jet area to the left atrial area, and other echocardiographic parameters were assessed relative to baseline.
- Vena contracta and jet area to left atrial area improved (p<0.05 and p<0.005, respectively).
The first-in-human AMADEUS study met its endpoint and demonstrated successful deployment of the Carillon device and a significant reduction in FMR.
AMADEUS was a single-arm, first-in-human study designed to evaluate the safety and feasibility of the Carillon system. The study utilized several independent bodies to minimize bias and increase rigor, including a blinded echo core lab, clinical events committee, and data and safety monitoring board. Key inclusion criteria included moderate to severe FMR, NYHA class II-IV, LVEDD >55mm, and ejection fraction <40% receiving sustained stable and optimal HF medication regimen. The study enrolled 48 patients with the device successfully implanted in 30 patients. At six months, the degree of FMR reduction among five different quantitative echo measures ranged from 22-32%.
- Dennis Rottländer, MD; Miriel Gödde, MD; Hubertus Degen, MD; Alev Ögütcü, MD; Michael Haude, MD, PhD. Percutaneous Coronary Sinus-Based Mitral Valve Annuloplasty in Atrial Functional Mitral Regurgitation. JACC: Cardiovascular Interventions. December 28, 2020
- Lipiecki, J, Fahrat, H, Séverine, M, et al. Long-term prognosis of patients treated by coronary sinus-based annuloplasty: single centre experience. ESC Heart Failure. October, 2020.
- Stephan Heyl, Aria Nikkhoo, Markus Wieszner, Stephan Fichtlscherer, Florian Seeger, Birgit Assmus, Brigitte Luu, Katrin Hemmann, Claudia Walther, Joerg Honold. Comparison of effectiveness and survival after the MitraClip or Carillon procedure for severe functional mitral regurgitation: a single-center retrospective analysis. Arch Med Sci Atheroscler Dis. June, 2020.
- Stephan Stöbe, Kristin Kreyer, Daniel Jurisch, Dietrich Pfeiffer, Daniel Lavall, Gerardo Farese, Ulrich Laufs, Andreas Hagendorff. Echocardiographic analysis of acute effects of percutaneous mitral annuloplasty on severity of secondary mitral regurgitation. ESC Heart Failure. May, 2020.
- Tobias Friedrich Ruf, Felix Kreidel, Alexander Robert Tamm, Martin Geyer, Omar Hahad, Julia Claudia Zirbs, Ben Luca Schwidtal, Andres Beiras-Fernandez, Klaus K. Witte, Thomas Münzel, Ralph Stephan von Bardeleben. Transcatheter indirect mitral annuloplasty induces annular and left atrial remodelling in secondary mitral regurgitation. ESC Heart Failure. April, 2020.
- Lipiecki, J, Kaye DM, Witte KK, et al. Long-Term Survival Following Transcatheter Mitral Valve Repair: Pooled Analysis of Prospective Trials with the Carillon Device. Cardiovascular Revascularization Medicine. February, 2020.
- Kałmucki P., Jerzykowska O., Dankowski R., Baszko A., Kramer L., Szyszka A., Siminiak T. Percutaneous Trans-Coronary Venous Mitral Annuloplasty in Patients With Functional Mitral Regurgitation: Analysis of Poznan Carillon Registry Data. J Interv Cardiol. 2016.
- Klein, N. et al. Mitral Annuloplasty Device Implantation for Non-Surgical Treatment of Mitral Regurgitation: Clinical Experience after the Approval Studies. Journal of Invasive Cardiology. February, 2016.
- Borisenko, O., Haude, M., Hoppe, UC., Siminiak, T., Lipiecki, J., Goldberg, S., Mehta, N., Bouknight, O., Bjessmo S., Reuter DG. Cost-utility analysis of percutaneous mitral valve repair in inoperable patients with functional mitral regurgitation in German settings. BMC Cardiovascular Disorders. 2015;15:43.
- Soofi, M.A., Alsamadi F. Restoration of Normal Left Ventricular Geometry after Percutaneous Mitral Annuloplasty: Case Report and Review of Literature. Catheterization and Cardiovascular Interventions. 2014.
- Siminiak T, Jerzykowska O, Kałmucki P, Link R, Baszko A. Cardiac resynchronization therapy after percutaneous trans-coronary-venous mitral annuloplasty. Kardiol Pol. 2013;71(12):1293-4.
- Woloszyn M, Jerzykowska O, Kałmucki P, Lunk R, Firek L, Kuzemczak M, Siminiak T. Functional assessment of patients after percutaneous mitral valvuloplasty with Carillon device: a preliminary report. Kardiol Pol. 2011;69(3):228-33.
- Jerzykowska O, Kalmucki P, Woloszyn M, Smuszkiewicz P, Firek L, Siminiak T. Echocardiographic evaluation of percutaneous vavle repair in patients with mitral regurgitation using the Carillon system. Kardiol Pol. 2010;68(1):57-63.
- Hoppe UC, Brandt MC, Degen H, Dodos F, Schneider T, Stoepel C, Kroener A, Haude M. Percutaneous mitral annuloplasty device leaves free access to cardiac veins for resynchronization therapy. Catheter Cardiovasc Interv. 2009;74(3):506-11.
- Lainscak M, Bohm, M. Embracing secondary mitral regurgitation with Carillon: past, present, and future. ESC Heart Failure 2020; 7: 3268-3270.
- Giallauria F, Di Lorenzo A, Parlato A, et. al. Individual patient data meta-analysis of the effects of the CARILLON® mitral contour system. ESC Heart Failure 2020; 7: 3383-3391.
- Khan MS et al.; Functional outcomes with Carillon device over 1 year in patients with functional mitral regurgitation of Grades 2+ to 4+: results from the REDUCE-FMR trial; ESC Heart Failure (2021); Published online in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/ehf2.13273.
- Khan MS et al.; Effect of Carillon Mitral Contour System on patient‐reported outcomes in functional mitral regurgitation: an individual participant data meta‐analysis; Published online in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/ehf2.13301.
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NOTE: The Carillon Mitral Contour System has received CE Mark (0344) and is available for sale in Europe and other countries that recognize CE Mark.
CAUTION: Investigational Device. Limited by United States law to investigational use.