Percutaneous Mitral Annuloplasty Research Articles

Clinical anatomy of the coronary venous system and relevance to retrograde cardioplegia and cardiac electrophysiological interventions.

Anomalies of coronary venous system, the valve of the coronary sinus (Thebesian valve) and other cardiac malformations may make interventions through the coronary sinus difficult. These variants may pose a challenge in cannulating the coronary sinus for retrograde cardioplegia and for interventions performed through the coronary sinus by cardiac electrophysiologist/interventional cardiologist. Retrograde cardioplegia is an established method of myocardial protection with advantages, indications, and complications. A good knowledge of the anatomy of the coronary sinus and its variants is important in understanding the difficulties encountered while cannulating the coronary sinus for the delivery of retrograde cardioplegia, cardiac resynchronization therapy, treatment of arrhythmias, and percutaneous mitral valve annuloplasty.

TCT-71 Outcomes of Percutaneous Mitral Annuloplasty With the Carillon Device: Retrospective Analysis of Implanted Versus Nonimplanted Patients

TCT-71 Outcomes of Percutaneous Mitral Annuloplasty With the Carillon Device: Retrospective Analysis of Implanted Versus Nonimplanted Patients

TCT-72 Improvement in Echocardiographic Mitral Regurgitation Parameters Correlates With LV Reverse Remodeling in Patients Undergoing Percutaneous Mitral Annuloplasty With the Carillon Technique

TCT-72 Improvement in Echocardiographic Mitral Regurgitation Parameters Correlates With LV Reverse Remodeling in Patients Undergoing Percutaneous Mitral Annuloplasty With the Carillon Technique

The CINCH-FMR postmarket registry: Real-world long-term outcomes with percutaneous mitral valve repair with the Carillon Mitral Contour System®

BackgroundThe Carillon® Mitral Contour System® has been studied in 4 prospective controlled studies in the treatment of functional mitral regurgitation (FMR) where it has been found to reduce mitral regurgitation, reduce left ventricular and atrial volumes, and be associated with improvements in clinical parameters. AimsThe CINCH post-market registry is designed to evaluate immediate, mid-term and long-term outcomes from a post-approval study of the Carillon® device evaluated in real-world practice. MethodsThe CINCH post-market registry is a single-arm study of percutaneous mitral annuloplasty with the Carillon device in patients with functional (secondary) mitral regurgitation and symptomatic congestive heart failure when utilized in real-world conditions. Patient selection, echocardiographic hemodynamic measurements, and patient follow-up requirements were performed per standard of care at each institution. ResultsA total of 101 patients treated with the Carillon device at 13 sites in Germany were enrolled in the CINCH registry. The mean age was 75 ± 9 years, 57 % were male, and patient presentation included primarily NYHA class III (69 %) with MR grade 3 (68 %). Over 5 years of follow-up, all-cause mortality was 40.1 %, the incidence of HFH was 53.9 %, and the composite outcome of HFH or death was 66.4 %. At each follow-up interval through 5 years, statistically significant reductions in NYHA class (p < 0.05) and MR grade (p < 0.01) were reported. ConclusionsIn this “real world” registry of the Carillon Mitral Contour System, procedural safety and medium-term follow-up outcomes is similar to the outcomes seen in the prospective, controlled clinical trials, despite being used in populations of patients that extend outside of those studied in the trials. The use of this therapy in patients with atrial functional mitral regurgitation, and heart failure with preserved ejection fraction, was notable, since these types of patients were excluded from the prospective, controlled trials. This supports possible additional patient populations who might benefit from this type of mechanical therapy. The safety profile of this therapy in this registry and in the earlier trials may support a potential role in earlier forms of secondary mitral regurgitation.

Percutaneous mitral annuloplasty with the Carillon device: Outcomes in proportionate and disproportionate functional mitral regurgitation

It has been suggested that the disparity of outcomes between the studies of transcutaneous edge-to-edge repair (TEER) for functional mitral regurgitation (FMR) in heart failure with reduced ejection fraction (HFrEF) could be due to systematic differences in the populations studied. One proposal is that there are two broad groups: those with proportional FMR who respond less favourably, and those in whom the FMR is greater than expected (disproportionate) FMR where edge-to-edge TEER seems to be more effective. Whether this grouping is relevant for other percutaneous interventions for FMR is unknown. We sought to compare clinical and echocardiographic outcomes of patients with HFrEF and proportionate and disproportionate FMR treated with indirect annuloplasty using the Carillon device. This is a pooled analysis from three trials of patients with FMR. Key patient eligibility in these trials specified persistent grade 2+ to 4+ FMR with >5.5 cm left ventricular (LV) end-diastolic diameter (LVEDD) and reduced ejection fraction. Patients with an effective regurgitant orifice area/LV end-diastolic volume (EROA/LVEDV) ratio under 0.15 were assigned to the proportionate FMR group (n=74;65%) and those with a ratio above 0.15 were classed as having disproportionate FMR (n=39;35%). At 12 months following treatment, both groups showed improvements in all MR variables including regurgitation volume, EROA and vena contracta. Moreover, in patients with proportionate MR there were clinically relevant and statistically significant improvements in LV volumes and diameters. There was no independent relationship between the degree of proportionality as a continuous variable and the remodeling response to Carillon therapy (change in LVEDV r=0.17; change in LVESV r=0.14). Percutaneous mitral annuloplasty with the Carillon device reduces MR in patients with both proportionate and disproportionate FMR, and also results in LV reverse remodeling in those with proportionate FMR. The effect on remodeling remains to be verified in a large scale trial.

Alternative methods to overcome the challenging anatomy of the coronary sinus during percutaneous mitral annuloplasty procedure.

Alternative methods to overcome the challenging anatomy of the coronary sinus during percutaneous mitral annuloplasty procedure.

November 2021 at a glance: focus on prevention, comorbidities, cardiogenic shock and novel devices.

November 2021 at a glance: focus on prevention, comorbidities, cardiogenic shock and novel devices.

Treating symptoms and reversing remodelling: clinical and echocardiographic 1-year outcomes with percutaneous mitral annuloplasty for mild to moderate secondary mitral regurgitation.

To determine the effects of percutaneous mitral annuloplasty on symptoms, walk distance and left ventricular (LV) structure and function in patients with mild or moderate secondary mitral regurgitation (SMR). This was a pooled analysis of patients (n= 68) who, despite guideline-directed medical therapy had symptomatic heart failure (HF) with mild (n= 25) or moderate (n= 43) SMR treated with percutaneous mitral annuloplasty as part of the TITAN, TITAN II, or REDUCE-FMR trials. Primary outcomes were changes in symptoms, 6-min walk distance, and quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) after 1year. Secondary analyses included changes in LV structure and function. At 1 year, New York Heart Association class status was maintained (48%) or improved (46%) in most patients, mean KCCQ scores increased from baseline by 10units [95% confidence interval (CI) 3 to17; P< 0.01] and mean 6-min walk test distance increased by 34 m (95% CI 12 to 57; P< 0.01). SMR grade improved in 25% of patients and was maintained in 58% of patients with changes in mean regurgitant volume of -7mL (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). There were non-significant improvements in LV ejection fraction and volumes. Survival over 1year was 89% with no difference between mild (96%) and moderate (86%) SMR (log-rank P= 0.22). Progression-free survival was 70% (82% in mild vs. 63% in moderate SMR; P= 0.16). Freedom from HF hospitalization was 73% (87% in mild SMR vs. 66% in moderate SMR; P= 0.07). Among patients with symptomatic HF and mild or moderate SMR on guideline-directed medical therapy, percutaneous mitral annuloplasty was associated with improvements in symptoms, SMR, a stabilization of LV structure and function, and high survival rates.

Percutaneous Mitral Valve Annuloplasty in Patients With Secondary Mitral Regurgitation and Severe Left Ventricular Enlargement

ObjectivesThis study sought to determine the effect of percutaneous mitral valve annuloplasty with the Carillon device versus guideline-directed medical therapy (GDMT) alone in patients with secondary mitral regurgitation (MR) and severe left ventricular (LV) enlargement. BackgroundThe clinical impact of the Carillon device in patients with severe LV dilation is not well established. MethodsThis is a pooled analysis involving 3 prospective trials (TITAN [Transcatheter Implantation of Carillon Mitral Annuloplasty Device], TITAN II, and REDUCE FMR [CARILLON Mitral Contour System for Reducing Functional Mitral Regurgitation] trials) in which patients with functional MR and severe LV enlargement (LV end-diastolic diameter >65 mm) were treated with GDMT and the Carillon device versus GDMT alone. 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). ResultsA total of 95 patients (67 in the Carillon group, 28 in the 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 U (p < 0.001), LV end-diastolic volume decreased by 25 cm3 (p = 0.005), and LV end-systolic volume decreased by 21 cm3 (p = 0.01). Significant functional improvement differences were also noted between the Carillon group and the GDMT group including an improvement of Kansas City Cardiomyopathy Questionnaire score (15 ± 4 vs. 6 ± 6; p = 0.03). The incidence of HFH was 29.9% versus 50.0% and the cumulative rate of HFH was 0.43 versus 0.75 (p < 0.001). ConclusionsIn patients with functional MR and severe LV enlargement, the Carillon device improved mitral valve function, LV morphology, and functional outcome compared with 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.

Reply: Cardiac CT prior to percutaneous coronary sinus-based mitral annuloplasty with the Carillon device.

Reply: Cardiac CT prior to percutaneous coronary sinus-based mitral annuloplasty with the Carillon device.

Letter: Cardiac CT prior to percutaneous coronary sinus-based mitral annuloplasty with the Carillon device.

Letter: Cardiac CT prior to percutaneous coronary sinus-based mitral annuloplasty with the Carillon device.

Echocardiographic analysis of acute effects of percutaneous mitral annuloplasty on severity of secondary mitral regurgitation.

AimsPercutaneous mitral annuloplasty (PMA) represents a new treatment option for secondary mitral regurgitation (SMR) being associated with higher morbidity and mortality. The present study was aimed to evaluate whether or not acute effects on SMR severity can quantitatively be assessed after PMA.Methods and resultsPMA was performed in 30 patients (mean age 76 ± 9; 37% males) with moderate (n = 14) or severe (n = 16) SMR. Vena contracta (VC), left ventricular (LV) velocity‐time‐integral ratio (VTIMV/LVOT), effective regurgitant orifice area (EROA) by two‐dimensional proximal isovelocity surface area (PISA), regurgitant volume (RVolPISA) and regurgitant fraction (RFPISA) by PISA, RVolvolume and RFvolume by LV volume analyses, and parameters describing LV morphology, function, and cardiac performance were assessed by transthoracic echocardiography prior to and after PMA. According to RFPISA/RFvolume, 14 patients showed mild, 15 moderate, and 1 severe SMR after PMA. Mean RF, RVol, EROA, VC, and VTIMV/LVOT were lower directly after PMA (RFPISA: 49% ± 11 vs. 34% ± 13, P < 0.001; RFvolume: 46% ± 10 vs. 34% ± 13, P < 0.001; RVolPISA: 33 mL ± 13 vs. 25 mL ± 12, P < 0.001; RVolvolume: 28 mL ± 17 vs. 20 mL ± 14, P < 0.05; EROAPISA: 0.24 cm2 ± 0.1 vs. 0.19 cm2 ± 0.1, P < 0.05; VC: 5.2 ± 0.1 vs. 4.1 ± 0.2, P < 0.001; VTIMV/LVOT: 1.9 ± 0.4 vs. 1.6 ± 0.5, P < 0.05). Parameters of LV morphology, function, and cardiac performance did not change directly after PMA.ConclusionsPMA leads to a reduction of MR severity in >80% of SMR patients. Acute effects of PMA can quantitatively be assessed by transthoracic echocardiography.

P912 Echocardiographic analysis of acute effects after treatment of functional mitral regurgitation by percutaneous mitral annuloplasty

Abstract Background Secondary or functional mitral regurgitation (FMR) is associated with increased morbidity and mortality, especially in heart failure patients, patients with many comorbidities and/or in the elderly. Previous studies about percutaneous mitral annuloplasty have shown evidence for long-term reduction of degree of FMR severity and left ventricular (LV) remodeling. In comparison to previous studies the present study did focus on the echocardiographic analysis of acute effects after percutaneous mitral annuloplasty (PMA). Methods Transthoracic echocardiography (TTE) has been performed in 30 patients with moderate or severe FMR before and after (± 3.5 days) percutaneous mitral annuloplasty (Carillon®). LV volumes and LV ejection fraction and semi-quantitative parameters, e.g. tenting Area, vena contracta and velocity-time-integral ratios of transmitral inflow and LV outflow (VTIMV/VTILVOT) were assessed. The assessment of the regurgitant volume (RV), regurgitant fraction (RF) and effective regurgitant orifice area (EROA) was quantitatively performed by the PISA method. RV and RF was also estimated by subtracting the effective forward stroke volume (SVLVOT, SVRVOT) from the total stroke volume (SVLV planimetry). Further, parameters of left ventricular contractility, e.g. global longitudinal strain (GLS), cardiac efficiency, peak power index etc., were assessed. Results a postinterventional reduction of degree of FMR severity was achieved in 25/30 patients (83%). In average, RF was reduced from 49 ± 11% to 34 ± 13% (p &amp;lt; 0.001), RV from 33 ± 13ml to 25 ± 12ml (p &amp;lt; 0.001) and EROA from 0.24 ± 0.1cm2 to 0.19 ± 0.1cm2 (p &amp;lt; 0.05). Significant decreases were also noted for vena contracta and VTIMV/LVOT. DiamMV (long axis) was reduced from 3.6 ± 0.6cm to 3.4± 0.6cm (p &amp;lt; 0.001), DiamMV (4-chamber view) from 3.9 ± 0.5cm to 3.6 ± 0.6cm (p &amp;lt; 0 .05). In patients with sinus rhythm (SR) or pacemacer stimulation a considerably higher reduction of RF was observed (ΔRF 20 ± 12%) in comparison to patients with atrial fibrillation (ΔRF 10 ± 12%). No significant changes were obtained for parameters of LV remodeling and LV contractility, e.g. GLS, cardiac efficiency, peak power index. Conclusion A reduction of degree of FMR severity can be achieved by percutaneous mitral annuloplasty (PMA) and acute effects can be quantitatively assessed by echocardiography. Further data are necessary to evaluate whether these acute effects will maintain in follow-up investigations. Abstract P912 Figure. Fig1-Reduction of RF and VC after PMA

Direct Percutaneous Mitral Annuloplasty in Patients With Functional Mitral Regurgitation: When and How.

Mitral regurgitation (MR) is a frequent valvular disease among patients deemed too high risk for surgery. Echocardiography along with CT is the primary diagnostic tool for MR and offers a comprehensive 3D assessment in patient selection and screening for the optimal treatment method. The direct percutaneous mitral annuloplasty addresses the underlying mechanisms of functional MR with a less invasive, catheter-based approach. The here-described techniques proved a sufficient safety profile, delivered significant MR reduction in most of the cases, and were associated with a notable improvement of symptoms. Although long-term outcome assessment is needed to support these early reports, the percutaneous mitral annuloplasty is likely to set a new standard of treatment in the forthcoming future.

Coronary Perforation From the Outside: Management of Unique Complication During Percutaneous Mitral Annuloplasty

An 88-year-old woman with severe symptomatic functional mitral regurgitation in spite of optimal medical therapy was referred for percutaneous mitral annuloplasty with the Cardioband system (Edwards Lifesciences, Irvine, California). Transesophageal echocardiogram revealed an ejection fraction of

Transient elevation of high-sensitive troponinT after Cardioband implantation.

The Cardioband system enables percutaneous surgical-like direct mitral valve annuloplasty and, thereby, repair of severe functional mitral valve regurgitation (MR) in patients with advanced systolic heart failure (HF) and dilation of the left ventricular (LV) annulus. Since the device is anchored by screws in the LV annulus, limited myocardial injury is likely to occur. Five patients (Society of Thoracic Surgeons score: 2.7 ± 0.7%) with severe HF (LV ejection fraction [LVEF]: 17 ± 1%; LV end-diastolic diameter [LVEDD]: 71 ± 3 mm) were treated with the Cardioband (sizes C-F) receiving 14-17screws in the LV annulus region. Myocardial injury was monitored by measuring high-sensitive cardiac troponinT (hsTnT) levels and by echocardiography. All patients showed significant periprocedural increase in hsTnT levels. Peak hsTnT concentration was reached between day1 and day6 (593 ± 141 pg/ml). None of the patients showed clinical signs of myocardial infarction, ST-segment elevation, new onset of deteriorated myocardial wall motion, or new ventricular tachycardia. hsTnT levels normalized in all patients after 14days (hsTnT on day0: 34 ± 6 pg/ml vs. hsTnT on day14: 36 ± 6 pg/ml; p = 0.604). This nonischemic hsTnT kinetics was compared to asixth patient who experienced proximal damage of the left circumflex artery (LCX) and ST-segment elevation during the Cardioband procedure, followed by immediate repair of the LCX, avoiding structural damage of the LV. Cardioband implantation is accompanied by significant elevation of hsTnT without causing structural myocardial damage or clinical symptoms such as worsening of LV function, new-onset LV regions exhibiting reduced wall motion, or ventricular tachycardia.

Fonksiyonel Mitral Yetersizliği Tedavisinde Perkütan Kapak Tamiri Sonrası Kardiyak Resenkronizasyon Tedavisi

We present a case of a 72-year-old female with symptomatic heart failure and ischaemic functional mitral regurgitation (FMR), who underwent a successful percutaneous trans-coronary venous mitral annuloplasty with the Carillon™ system. The procedure resulted in some clinical improvement but patient was still very symptomatic. Six months later, the patient underwent cardiac resynchronisation (CRT) device implantation, resulting in a further improvement in clinical and echo­cardiographic measures of FMR. This case suggests a possible synergistic effect between CRT and percutaneous trans-coronary-venous mitral annuloplasty.

Sex differences in diameter of the coronary sinus ostium: Correlation with weight of the heart

Diameter of the coronary sinus ostium is important in the designing of cannulation devices used in cardiac resynchronization therapy and percutaneous mitral valve annuloplasty. Population variation of the diameter may account for the failure rate of these procedures. Studies of the coronary sinus ostium from African populations are scarce and altogether absent for Kenya. Therefore, this study aimed at determining sex differences in the diameter of coronary sinus ostium and its correlation with the weight of the heart. Seventy-four hearts of adult black Kenyans [43 male, 31 females; age range 20 – 70 years] obtained during autopsy at the Department of Human Anatomy, University of Nairobi, Kenya were weighed. The coronary sinus ostium was identified and its transverse and supero-inferior diameters measured in millimeters. The measurements were analyzed using SPSS version 17. Sex comparison was established using student’s t test. Association between diameter and heart weight was established using Pearson’s correlation test and considered significant at a p-value of ≤0.05. Data were presented using scatter plots. Transverse and supero-inferior diameters of the ostium were 11.04±1.88mm and 9.50±1.80mm respectively. The mean diameter was 10.27 mm. These correlated positively with weight of the heart. When corrected for weight of the hearts, the transverse and supero-inferior diameters were larger in females (0.042 and 0.036 respectively) than in males (0.034 and 0.03 respectively). The diameter of coronary sinus ostium is larger in females and shows positive correlation with weight of the heart. These data should be considered during design and use of cardiac devices introduced through the coronary sinus.Key words: Coronary sinus, ostium, diameter, sex difference.

Percutaneous Trans-Coronary Venous Mitral Annuloplasty in Patients With Functional Mitral Regurgitation: Analysis of Poznan Carillon Registry Data.

The purpose of our study is to verify, whether percutaneous mitral annuloplasty results in reverse remodeling in patients with functional mitral regurgitation (FMR) and impaired ejection fraction (EF) and to investigate which echo parameters may help in prediction of the efficacy of the procedure. FMR exacerbates left ventricular (LV) dilatation and contributes to both LV remodeling and heart failure. We analyzed baseline and 1 month follow-up data in 22 consecutive patients with FMR, who underwent successful percutaneous trans-coronary venous mitral annuloplasty with the Carillon device. Significant reduction of FMR echo parameters, including vena contracta (VC), effective regurgitant orifice area (EROA), and regurgitant volume (RV) were observed and maintained throughout 1 month follow up and did not correlate with baseline annular, LV or with the left atrial diameters. Baseline mitral tenting area correlated negatively with the relative improvement (% difference) of EROA (r = -0.5898) and RV (r = -0.4363), but not with VC (r = 0.1341). In addition, increased EF as well as a significant reduction in left ventricular diameters were noted. The increase in EF negatively correlated with the change in EROA (r = -0.50058), PISA (r = -0.5327), and RV (r = -0.5457). Baseline mitral tenting area significantly correlated with the 1 month change in EF (r = 0.5946) and stroke volume (r = 0.6913). The improvement of FMR after treatment with the Carillon device is associated with LV reverse remodeling and an increase in systolic performance, that correlates with the reduction in mitral regurgitation, being not dependent on baseline heart diameters. Mitral tenting area seems to be an important parameter in prediction of benefit from percutaneous mitral annuloplasty.

TCT-639 The Impact of Mitral Regurgitation Severity on Efficacy of Percutaneous Mitral Valve Annuloplasty in Functional Mitral Regurgitation

TCT-639 The Impact of Mitral Regurgitation Severity on Efficacy of Percutaneous Mitral Valve Annuloplasty in Functional Mitral Regurgitation