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

OBJECTIVES: 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. BACKGROUND: FMR exacerbates left ventricular (LV) dilatation and contributes to both LV remodeling and heart failure. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

B-type natriuretic peptide in patients after percutaneous trans-coronary-sinus mitral annuloplasty.

BACKGROUND AND AIM: Functional mitral regurgitation (MR) remains a significant clinical problem. Surgical valve repair carries a high procedural risk. Thus, percutaneous techniques are under development. One of the most advanced devices for percutaneous mitral annuloplasty (PTMA) is the Carillon™ device. B-type natriuretic peptide (BNP) is a marker of haemodynamic status in heart failure patients. So far, its usefulness in patients after PTMA is unknown. METHODS: Thirteen consecutive patients after successful implantation of the Carillon™ device were enrolled. PTMA was achieved through the coronary sinus in order to improve leaflet coaptation. Before PTMA, immediately after, and at one month follow-up, transthoracic echocardiography was performed. Furthermore, plasma BNP levels, the six-minute walk test (6MWT) and the Naughton treadmill exercise test were evaluated before PTMA and after one month. RESULTS: In patients after successful PTMA, significant improvement in echocardiographic parameters was maintained at one-month follow-up: vena contracta (0.31 ± 0.03 vs. 0.64 ± 0.03 cm, p < 0.05), effective regurgitant orifice area (0.2 ± 0.02 vs. 0.32 ± 0.05 cm², p < 0.05), MR jet area/left atrial area (32.33 ± 1.98 vs. 47.06 ± 2.3%,p < 0.05) and regurgitant volume (27.84 ± 2.17 vs. 45.25 ± 7.47 mL, p < 0.05). Both the duration of the exercise test (4.3 ± 0.45 vs. 3.12 ± 0.18 min, p < 0.05) and 6MWT (320 ± 29.63 vs. 295.2 ± 13.4 m, p < 0.05) improved. Furthermore, improvement of the NYHA class was observed. Despite that, mean BNP levels remained unchanged (405.3 ± 133.9 vs. 596.5 ± 245.2 pg/mL, p = 0.191; after and before the procedure, respectively). In some patients with device located above the annulus level, an increase in BNP leve ls was observed. CONCLUSIONS: BNP seems to be useless for the assessment of patients after PTMA. This may be related to mechanical stress on the annulus and atrial wall caused by the device itself.

Cardiac resynchronisation therapy after percutaneous trans-coronary-venous mitral annuloplasty.

We present a case of a 45-year-old man 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 clinical improvement as well as in a decrease in the degree of MR as assessed by echocardiography. Fifteen months later, the patient underwent cardiac resynchronisation (CRT) device implantation, resulting in a further improvement in echocardiographic measures of FMR. This case not only confirms the feasibility of CRT after percutaneous trans-coronary-venous mitral annuloplasty, but also suggests a possible synergistic effect of both therapies, warranting future clinical trials.

Value of rotational angiography (3D-ATG) with contrast agent administration into the right atrium during atrial fibrillation ablation procedures: a preliminary report.

BACKGROUND: Efficacy and safety of radiofrequency (RF) ablation in patients with atrial fibrillation (AF) strongly depend on the possibility of three-dimensional (3D) visualisation of atria as well as the ostia of pulmonary veins. Current angiographic systems allow 3D visualisation of anatomical heart structures using rotational angiography. AIM: To evaluate clinical usefulness of rotational angiography (3D-ATG) after contrast agent administration into the right atrium for the purpose of evaluating left atrial anatomy in patients undergoing RF ablation of AF. METHODS: We also compared images obtained using 3D-ATG with magnetic resonance imaging (MRI). In 18 consecutive patients undergoing RF ablation of AF or left-atrial tachycardia, 3D-ATG was performed uneventfully, followed by 3D reconstruction of the left atrium and the aorta. Ablation using the CARTO 3 system was successful in 17 patients. Total ablation time was 127 ± 28 min, fluoroscopy time 31 ± 8 min, and radiation dose was 413 ± 170 mGy. Mean fluoroscopy time for 3D-ATG was 1.75 ± 0.4 min and the mean radiation dose was 159 ± 57 mGy. Appropriate 3D visualisation of the left atrium was possible in 17 patients, including 16 patients in whom all 4 pulmonary venous ostia were imaged. In 1 patient, all right-sided pulmonary veins were located outside the scan area. In 1 case, 3D-ATG did not allow visualisation of the right inferior pulmonary vein, and in another case the left-sided veins had a common ostium as shown in MRI but not visualised in 3D-ATG. RESULTS: Pulmonary vein diameter assessed by 3D-ATG was slightly higher than by MRI (16.6 ± 3.2 vs. 15.2 ± 3.6 mm, p = 0.28), although this was mainly related to a single nonvisualised right inferior pulmonary vein. Good agreement (< 2 mm) between the two methods for the assessment of pulmonary venous ostia was higher for the right-sided than the left-sided veins (62.5% vs. 44%, p = 0.03). CONCLUSIONS: We conclude that 3D-ATG after contrast agent administration into the right atrium seems to be a safe and effective method to visualise pulmonary venous ostia and left atrial anatomy. It remains to be established whether it enables evaluation of anatomical anomalies.

Functional assessment of patients after percutaneous mitral valvuloplasty with Carillon™ device: a preliminary report.

BACKGROUND: Functional mitral regurgitation (MR) due to dilated cardiomyopathy or coronary artery disease remains a significant clinical problem. These clinical entities lead to left ventricular enlargement, which results in annular dilation and MR. Surgical valvuloplasty is associated with a high perioperative risk. This is the reason why percutaneous techniques for mitral valve repair are under development. One of the most advanced devices for mitral annuloplasty is the Carillon™ system. AIM: Functional assessment of patients who have undergone mitral annuloplasty using the Carillon™ device. METHODS: Fourteen consecutive patients with functional MR who had undergone successful implantation of the Carillon™ device were enrolled. The device was implanted into the venous system of the heart and applied tension to the mitral annulus in order to improve coaptation of the cusps and reduce MR. In implanted patients echocardiographic MR parameters (vena contracta, effective regurgitant orifice area) were assessed before, immediately after the procedure and during 1-month follow-up. Furthermore, the 6-minute walk test (6MWT), Naughton stress test and the NYHA functional class assessment were performed before the procedure and at 1 month. Quality of life was evaluated by the Kansas City Cardiomyopathy Questionnaire. One month after the procedure patients were also asked to compare their health status with their baseline condition. RESULTS: In implanted patients improvement of echocardiographic MR parameters was observed, both immediately after the procedure and during 1 month follow-up. These parameters included vena contracta (0.36 ± 0.03 and 0.31 ± 0.03 vs 0.65 ± ± 0.04 cm, both p < 0.001) as well as effective regurgitant orifice area (0.18 ± 0.02 and 0.20 ± 0.02 vs 0.28 ± 0.04 cm², p < 0.05 and p < 0.005, respectively). One month after the procedure the 6MWT (390 ± 26.25 vs 311.9 ± 15.71 m, p < 0.001), Naughton treadmill exercise test (5.06 ± 0.47 vs 3.49 ± 0.27 min, p < 0.005) and NYHA classification (1.93 ± ± 0.20 vs 2.93 ± 0.07, p < 0.005) were significantly improved. Quality of life improved from 67.93 ± 3.30 at baseline to 88.31 ± 4.02 at 1 month (p < 0.001). All the patients reported some degree of improvement at 1 month compared to baseline. CONCLUSIONS: Implantation of the Carillon™ device in patients with functional MR leads to increased exercise capacity and improvement of selected echocardiographic MR parameters. Randomised trials are needed to assess the clinical value of the technique. Kardiol Pol 2011; 69, 3: 228-233.

Echocardiographic evaluation of percutaneous valve repair in patients with mitral regurgitation using the CARILLON system.

BACKGROUND: Dilated cardiomyopathy is characterised by significant enlargement of cardiac chambers, which can lead to functional mitral regurgitation. Surgery is a widely accepted treatment of secondary mitral regurgitation. Conventional cardiac surgery has a high procedural risk and therefore new techniques for percutaneous repair of mitral valve are being developed. The CARILLON system is one of devices that is implanted into the coronary venous system, which enables tension of the mitral ring in order to improve coaptation of the leaflets. AIM: Echocardiographic analysis of the CARILLON system implantation efficacy evaluated directly and one month after implantation. METHODS: The study in included 9 patients, aged 58.56 +/- 6 years, with severe functional mitral regurgitation, who fulfilled the following echocardiographic criteria: large central jet l 4 cm(2) or l 20% of the left atrium area or wall-impinging eccentric jet reaching the pulmonary veins, vena contracta (VC) l 0.30 cm, effective regurgitant orifice area (ERO) l 0.2 cm(2), regurgitant volume (RV) l 30 ml or regurgitant fraction (RF) > 30%. Exclusion criteria were: concomitant severe tricuspid valve insufficiency, significant organic mitral valve pathology, chronic atrial fibrillation, foreign body in the coronary sinus, or thrombus in the left atrial appendage. The prerequsite for implanting the device was a significant reduction in the mitral regurgitation jet observed by transesophageal echo-cadiography (TEE), seen during the procedure. After one month, a transthoracic echocardiography (TTE) was performed to evaluate mitral regurgitation by analysing the same parameters assessed before implanting CARILLON to the coronary sinus. RESULTS: A significant improvement of VC after the procedure, in comparison to the value before the procedure (0.43 +/- 0.12 vs. 0.66 +/- 0.14 cm, p < 0.05), was observed. This improvement was lower one month after the implantation of the device (0.35 +/- 0.1 cm, p < 0.005). The ratio of the jet area to the left atrial area was reduced from 54.96 +/- 11.18% to 38.57 +/- 9.79% (p < 0.005) and sustained after a month at 36.33 +/- 10.15% (p < 0.005). Other echocardiographic parameters of evaluation of mitral regurgitation tended to improve, however the differences did not reach statistical significance. The ERO in subsequent studies was: 0.25 +/- 0.09 cm(2), 0.23 +/- 0.07 cm(2), and 0.24 +/- 0.07 cm(2), and RV decreased from 33.06 +/- 11.81 ml before the procedure, to 32.33 +/- 7.84 ml one month after the procedure. CONCLUSIONS: The CARILLON system implantation to the coronary venous system in patients with secondary mitral regurgitation can lead to the improvement of selected echocardiographic indices of mitral regurgitation.

Changes in heart rate variability caused by coronary angioplasty depend on the localisation of coronary lesions.

BACKGROUND: Coronary angioplasty (PTCA) is a common treatment method in patients with coronary heart disease, but its effects on heart rate variability (HRV) have not been well established. AIM: To verify whether the localisation of coronary lesion undergoing PTCA affects HRV parameters. METHODS: Ninety six consecutive individuals underwent elective coronary angiography with subsequent ad hoc successful PTCA. Two five-minute ECG were recorded, one before PTCA and the second 24-hour after PTCA. The HRV indices were determined by means of classical and 'new' mathematical models. RESULTS: The PTCA-induced changes in HRV variables depended on the localisation of dilated lesion. PTCA of the circumflex artery revealed the most significant HRV changes--a decrease in value of domain indices: Yeh DI (0.033+/-0.031 vs. 0.011+/-0.006 un/unitless, p=0.005), Yeh II (0.053+/-0.039 vs. 0.032+/-0.013 un, p=0.017), Organ BAND (9.101+/-9.245 vs. 4.62+/-2.205 bpm/beat per minute, p=0.031), Huey STV (208.821+/-262.248 vs. 76.444+/-35.281 bpm, p=0.013), Dalton MABB (15.733+/-16.575 vs. 7.57+/-4.89 ms, p=0.015), Dalton SD (48.741+/-37.468 vs. 27.759+/-10.533 ms, p=0.015), Zugaib STV (0.0129+/-0.0132 vs. 0.005+/-0.003 un, p=0.005), SDNN (27.204+/-18.592 vs. 21.329+/-32.784 ms, p=0.044), rMSSD (56.239+/-19.751 vs. 51.496+/-43.889 ms, p=0.025) and increased LF/HF (2.384+/-2.072 vs. 5.632+/-5.379 un, p=0.044). Angioplasty of the right coronary artery resulted in decreased AR TP (18.273+/-2.296 vs. 17.085+/-2.256 ms(2), p=0.017) and alteration of the sympathovagal balance of the autonomic nervous system towards predominance of sympathetic activity: AR LF (0.264+/-0.029 vs. 0.284+/-0.040 un, p=0.007), LF/HF (4.310+/-4.457 vs. 6.958+/-7.013 un, p=0.018), HF (0.199+/-0.165 vs. 0.141+/-0.157 un, p=0.031), AR HF (0.647+/-0.043 vs. 0.621+/-0.054 un, p=0.014). PTCA of the left anterior descending artery caused no change. CONCLUSION: Changes in heart rate variability caused by coronary angioplasty depend on the localisation of coronary lesions.

Percutaneous valve repair for mitral regurgitation using the Carillon Mitral Contour System. Description of the method and case report.

Mitral regurgitation may result from left ventricular dilatation and cause progression of heart failure. Percutaneous techniques for mitral valve repair are under development. Techniques utilizing a trans-coronary venous approach exploit the anatomical relationship between the mitral annulus and the venous system of the heart. The coronary sinus, great cardiac vein and the origin of the anterior interventricular vein surround the posterior mitral annulus. This enables percutaneous approaches to annuloplasty for mitral regurgitation. Devices can be implanted into the coronary veins that modify the shape and size of the mitral annulus. We present a case of ischaemic mitral regurgitation successfully treated by use of a percutaneous approach, the Carillon Mitral Contour System. Significant reduction of the mitral regurgitation jet was observed. The patient was discharged 4 days after the procedure. During the follow-up visits, the patient showed an improved general condition and increased exercise capacity. Procedural steps are shown in detail and the current status of the coronary sinus based technique is discussed. Percutaneous techniques for mitral valve repair may be an attractive alternative to cardiac surgery in heart failure patients with secondary mitral regurgitation. The Carillon Mitral Contour System is under ongoing clinical evaluation in the AMADEUS trial.

Percutaneous trans-coronary-venous transplantation of autologous skeletal myoblasts in the treatment of post-infarction myocardial contractility impairment: the POZNAN trial.

AIMS: Several experimental studies and the initial clinical experience have shown that autologous skeletal myoblast transplantation into the area of post-infarction left ventricular injury results in an increase in segmental contractile performance. This phase I clinical trial was designed to assess the feasibility and safety of autologous skeletal myoblast transplantation performed via a percutaneous trans-coronary-venous approach in patients with post-infarction left ventricular dysfunction. METHODS AND RESULTS: Ten patients with heart failure and presence of an akinetic or a dyskinetic post-infarction injury with no viable myocardium were included in the study. Skeletal myoblasts were obtained from a biopsy specimen and grown in cell culture. Patients were treated with prophylactic amiodarone infusion before and during the procedure, except one patient. Skeletal myoblast transplantations were performed uneventfully in nine patients using the TransAccess catheter system under fluoroscopic and intravascular ultrasound guidance. In one patient, the procedure was not performed because of the inability of appropriate coronary sinus guiding wire positioning across venous valve. In five patients, the anterior interventricular vein and in four patients, the middle cardiac vein were used to access the myocardium. Two to four intramyocardial injections 1.5-4.5 cm deep were performed in each patient, delivering up to 100 million cells in 0.4-2.5 mL of saline. During 6 months follow-up, New York Heart Association class improved in all patients and ejection fraction increased 3-8% in six out of nine cases. CONCLUSION: These data suggest the feasibility and procedural safety of myoblast transplantation performed via the trans-coronary-venous approach using the TransAccess catheter system.

Autologous skeletal myoblast transplantation for the treatment of postinfarction myocardial injury: phase I clinical study with 12 months of follow-up.

BACKGROUND: Experimental studies have shown that skeletal myoblast transplantation into an area of postinfarction left ventricular injury results in an increase of segmental contractile performance that could be related to transplanted myoblasts. Initial experience with autologous skeletal myoblast transplantation in patients with postinfarction myocardial injury has also been obtained. METHODS: Patients who survived an acute myocardial infarction and were scheduled to undergo coronary artery bypass grafting were screened by means of dobutamine stress echocardiography and included into the study when no contractility changes within akinetic/dyskinetic segments were observed. Ten patients who gave informed consent were enrolled, and autologous myoblasts (satellite cells) were isolated from the skeletal muscle biopsy. Myoblast injections into the akinetic/dyskinetic area were performed after constriction of the anastomoses during the coronary artery bypass grafting procedure. RESULTS: Myoblast transplantations were performed after 3 weeks of in vitro culture in all patients. One patient died of a recent infarction at day 7 postoperatively because of a recent infarction in a remote area of the left ventricle. The left ventricular ejection fraction increased from 25% to 40% (mean, 35.2%) before the procedure to 29% to 47% (mean, 42.0%) during the 4-month visit (P <.05), and the effect was maintained throughout 12 months of follow-up. Sustained ventricular tachycardia was observed in 2 patients in the early postoperative period and in the other 2 patients after 2 weeks of follow-up. Prophylactic amiodarone infusion was used in the remaining 8 patients and prevented sustained ventricular tachycardia episodes. CONCLUSIONS: Autologous skeletal myoblast transplantation for the treatment of postinfarction heart failure is feasible. Our initial observations justify further research to validate this method in a clinical practice.

Percutaneous autologous myoblast transplantation in the treatment of post-infarction myocardial contractility impairment--report on two cases.

Numerous animal experimental studies as well as the initial human experience have shown that autologous skeletal myoblast transplantation into area of post-infarction left ventricular injury results in an increase in segmental contractile performance related to contraction of cells differentiated from transplanted myoblasts. We have previously introduced skeletal myoblast transplantation performed at the time of coronary artery bypass grafting. Currently, we report the first two cases in Poland of percutaneous autologous myoblast transplantation in the treatment of post-infarction heart failure. The procedures were performed using a catheter system enabling intra-myocardial injections from the lumen of cardiac veins under intravascular ultrasound guidance. Lack of major procedural complications and expected benefits from myocardial regeneration in patients with post-infarction heart failure justify initiation of phase one clinical trial to evaluate this method.

Autologous bone marrow stem cell transplantation in acute myocardial infarction-report of two cases.

The results of numerous experimental and clinical studies evaluating transplantation of bone marrow-derived pluripotential stem cells into the area of postinfarction myocardial injury, including direct myocyte precursors, are very encouraging. We have previously reported our clinical experience with transplantation of autologous skeletal myoblasts in the treatment of postinfarction myocardial injury. Currently, we report on two cases of intracoronary autologous bone marrow - derived CD34+ stem cells transplantation during acute phase of myocardial infarction. Lack of major procedural complication and expected benefits resulting from myocardial regeneration justify the initiation of a clinical study evaluating the use of this method in the treatment of patients with myocardial infarction. Our current report is only a method description and the two first cases presentation, indicating its feasibility - evaluation of the efficacy requires future investigations.