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

BACKGROUND: 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 2 broad groups: those with proportional FMR who respond less favorably, 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. OBJECTIVES: 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. METHODS: This is a pooled analysis from 3 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%). RESULTS: 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). CONCLUSION: 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.

The long-term benefit of a cardiac rehabilitation program after myocardial infarction in patients under the Managed Care for Acute Myocardial Infarction Survivors (MACAMIS) program in Poland: A single-center study.

BACKGROUND: The Managed Care for Acute Myocardial Infarction Survivors (MACAMIS) program introduced for patients after myocardial infarction (MI) consists of 4 modules including early cardiac rehabilitation (CR). AIMS: We compared the impact of CR on survival of patients after MI included in the MACAMIS program. METHODS: Patients in MACAMIS were divided into subgroups based on being qualified or not qual-ified for CR and on whether they completed or failed to complete CR. We evaluated one-, two-, and three-year mortality. RESULTS: Of 244 patients in MACAMIS, 174 patients were qualified for CR. They were younger, had less advanced coronary artery disease (CAD), higher ejection fraction (EF), and fewer comorbidities. Finally, 102 (58.6%) patients completed CR. These patients were younger and more likely to have STEMI; they were more often treated invasively, with no differences in comorbidity burden. The survival rates at one, two, and three years were 93.6%, 87.8%, and 65.0%, respectively. Patients who qualified for CR had a better prognosis. The mortality rates at one, two, and three years were 2.38% vs. 16.18% (P = 0.0003), 6.71% vs. 25.4% (P = 0.002), and 26.87% vs. 51.35% (P = 0.01), respectively. Patients who completed CR, again, had a significantly better prognosis. The mortality rate was 1% vs. 10.29% (P = 0.009), 4.17% vs. 17.56% (P = 0.002), and 23.33% vs. 40.54% (P = 0.09) in analyzed periods. The only independent factors related to survival were completion of CR and number of comorbidities. CONCLUSIONS: Patients with MI in the MACAMIS program had better prognosis when participating in CR. After completing the MACAMIS program, increased mortality was observed in the following years. Despite the flexibility of the CR program, the proportion of patients who qualified and completed CR remained low.

Electrocardiographic criteria for anterior STEMI - Does the cut-off point affect treatment delay?

BACKGROUND: Diagnostic criteria for anterior STEMI differ between the European Society of Cardiology (ESC) and the European Resuscitation Council (ERC). A greater degree of ST-segment elevation is required to meet ERC criteria compared to ESC criteria. This may potentially lead to discrepancies in management between emergency teams and cardiologists, subsequent delay in reperfusion therapy and worse prognosis. METHODS: We performed an observational study in patients with anterior STEMI routinely treated with primary PCI and assessed whether differing electrocardiographic diagnostic criteria could impact treatment and short-term prognosis. All patients in the study had anterior STEMI confirmed by electrocardiographic ESC criteria and subsequent coronary angiography. Patients were divided into two groups. Those who did not meet ERC criteria in the index ECG were assigned to the "non-ERC" group and were compared with those who met them - the "ERC" group. RESULTS: Out of 60 patients with anterior STEMI based on ESC criteria (mean age 66.9 ± 13.6 years, 70% males), 26 patients (44%) did not meet ERC criteria ("non-ERC" group) for STEMI. There were no significant differences in age, gender distribution or clinical characteristics between "ERC" and "non-ERC" patients. Total-Ischemic-Time, Patient-Delay, and System-Delay times were significantly longer in "non-ERC" group (433.1 ± 389.9 min vs. 264.2 ± 229.6 min, p = 0.03; 290.8 ± 337.6 min vs. 129.5 ± 144.9 min; p < 0.05 and 158.8 ± 158 vs 134.6 ± 191 min, p < 0.02 respectively). There were no differences in In-Hospital-Delay, procedure duration, and success rate of PCI. Proximal LAD occlusion (64.7%) and TIMI = 0 flow (73.5%) tended to be more frequently observed in "ERC" than in the "non-ERC" group (53.8% and 65.4%, respectively). Hospitalization time and LVEF (44.4 ± 8.7 vs 42.8 ± 9.5%, p = 0.53) were similar between groups. CONCLUSIONS: Differences in electrocardiographic criteria for anterior STEMI leave a significant proportion of patients undiagnosed. Patients with STEMI who failed to meet less strict ERC criteria had more distal LAD disease with better TIMI flow but received reperfusion therapy later. Thus, character of the disease may compensate for treatment delay but this needs to be further evaluated. Finally, lowering the cut-off point with stricter criteria compromises specificity and is expected to increase the false positive rate, however there were no false positives in this study as all patients were angiographically confirmed to have acute coronary obstruction.

Long-term results of irrigated bipolar radiofrequency ablation in patients with recurrent arrhythmia after failed unipolar ablation.

INTRODUCTION: The RF ablation of ventricular tachycardia (VT) or atrial flutter (AFl) can be unsuccessful due to lack of lesion transmurality. Bipolar ablation (BA) is more successful than unipolar ablation (UA). The purpose of our study was to investigate the long-term effect of BA ablation in patients after failed UA. METHODS: Patients with septal VT (5) or AFL (2) after 2 to 5 unsuccessful UA were prospectively analysed after BA. All patients presented with heart failure or had ICD interventions. RESULTS: BA was successful in 5 patients (1 failure each in the AFL and VT group). The follow-up duration was 10 to 26 months. In AFL group, BA was successful in 1 patient, unidirectional cavotricuspid block in was achieved in the other patient. All patients were asymptomatic for 12 months, but 1 had atrial fibrillation and the other had AFL reablation 19 months after BA. In VT group, all patients had several forms of septal VT. BA was successful in 4 patients. In 2 patients with high septal VT BA resulted in complete atrioventricular block. During follow-up, 1 patient had VT recurrence 26 months after BA and died after an unsuccessful reablation. Three patients had VT recurrences of different morphologies, which required reablation (UA in 2 and alcohol septal ablation in the other patient). CONCLUSION: BA was successful in patients with AFL and septal VT resistant to standard ablation. Relapses of clinical arrhythmia are rare; however, long-term follow-up is complicated by recurrences of different arrhythmias related to complex arrhythmogenic substrate.

Emergency treatment of iatrogenic coronary perforation by transcatheter embolization with gelatin sponge particles-Description of technique.

Coronary artery perforation (CAP) is a rare but potentially life-threatening complication of percutaneous coronary intervention (PCI) that requires prompt diagnosis and effective treatment. Importantly, dynamic advances in interventional cardiology reflected by the increasing percentage of more challenging PCIs performed in more complex lesions have resulted in significant changes in CAPs pattern. Herein, we describe a technique and present a case report of CAP that occurred during percutaneous recanalization of the occluded restenotic right coronary artery (RCA) successfully treated with transcatheter embolization using gelatin sponge particles prepared on-site. The patient underwent coronary angiography with a subsequent attempt to open chronically occluded RCA. During the procedure, a guidewire was inadvertently positioned outside the arterial bed resulting in type III CAP. After unsuccessful prolonged balloon inflations as well as an anticoagulation reversal, embolization of the RCA with gelatin sponge particles as an ultima ratio treatment was performed. Sponge particles were prepared on-site by the operator, by cutting gelatin sponge used for wound healing. The procedure resulted in a total occlusion of the RCA and significant clinical improvement. The patient did not require pericardiocentesis and was discharged from the hospital after 10 days of an uneventful postprocedural course. The described technique is an easy and effective method of guidewire-related CAPs treatment in whom stent grafts cannot be implanted. Noteworthy, the technique can be applied in most cath labs as it utilizes a widely available gelatin sponge and does not require any specific expertise.

A Successfully Treated STEMI Due to Simultaneous Thrombotic Occlusion of Left Anterior Descending Artery and Left Circumflex Artery: A Case Report and Review of the Literature.

ST-segment elevation myocardial infarction (STEMI) due to simultaneous double vessel thrombotic occlusion of two major coronary arteries is an extremely rare clinical entity. Available studies indicate that most frequently it affects two coronary arteries originating from different sides of a coronary tree (i.e. right coronary artery (RCA) and left anterior descending artery (LAD) or RCA and left circumflex artery (LCx)) and usually has a fatal clinical course. However, it must be pointed out that the data have been derived from studies before the era of a widely-used pre-hospital electrocardiogram (ECG) teletransmission. Herein, we present a case report of successfully-treated STEMI due to simultaneous occlusion of LAD and LCx. Furhtermore, the case report highlights a crucial role of ECG teletransmission for immediate treatment and survival of patients with the so-called "the deadly double infarct syndrome".

Safety of transesophageal echocardiography­guided electrical cardioversion in patients with atrial fibrillation and inadequate anticoagulation.

INTRODUCTION    Restoring sinus rhythm in patients with atrial fibrillation (AF)/atrial flutter (AFl) requires adequate oral anticoagulation prior to direct current cardioversion (DCC). Some patients eligible for DCC are not properly anticoagulated. OBJECTIVES    The aim of the study was to assess risk factors for thrombus and spontaneous echo contrast (SEC) in the left atrium (LA) as well as the safety profile of transesophageal echocardiography (TEE)-guided DCC in patients with inadequate anticoagulation. PATIENTS AND METHODS    From the cohort of 316 patients admitted for DCC, 139 patients (mean [SD] age, 63.4 [11.5] years) had inadequate anticoagulation; 91 patients were admitted urgently for acute coronary syndrome, heart failure (HF), or poor tolerance of arrhythmia. The mean (SD) CHA2DS2­VASc score was 3.0 (1.7). RESULTS    TEE revealed a left atrial appendage (LAA) thrombus in 16 patients (11.5%), and SEC in the LA in 63 patients (45.3%). In a univariate analysis, LAA thrombus was more common in patients after myocardial infarction (odds ratio [OR], 3.92; 95% CI, 1.34-11.48; P = 0.009), while SEC in the LA was more common in patients with HF (OR, 2.23; 95% CI, 1.1-4.53; P = 0.02) and left ventricular ejection fraction of less than 40% (OR, 3.65; 95% CI, 1.66-8.06; P = 0.001). In a multivariate model, the most powerful SEC­predicting factor was the LA size exceeding 45 mm (OR, 3.08; 95% CI, 1.3-7.29). DCC was performed in 105 patients. No complications of TEE or DCC were observed. CONCLUSIONS    AF/AFl inadequately treated with oral anticoagulation predisposes to thrombus formation and SEC in the LA. Once thrombus is excluded, DCC is a safe procedure. There were no predictors of LAA thrombus; therefore, TEE before DCC should be performed in all patients with AF/AFl in accordance with the guidelines.

Cath lab costs in patients undergoing percutaneous coronary angioplasty - detailed analysis of consecutive procedures.

BACKGROUND: Costs of percutaneous coronary interventions (PCI) have an important impact on health care expenditures. Despite the present stress upon the cost-effectiveness issues in medicine, few comprehensive data exist on costs and resource use in different clinical settings. AIM: To assess catheterisation laboratory costs related to use of drugs and single-use devices in patients undergoing PCI due to coronary artery disease. METHODS: Retrospective analysis of 1500 consecutive PCIs (radial approach, n = 1103; femoral approach, n = 397) performed due to ST segment elevation myocardial infarction (STEMI; n = 345) and non ST-segment elevation myocardial infarction (NSTEMI; n = 426) as well as unstable angina (UA; n = 489) and stable angina (SA; n = 241) was undertaken. Comparative cost analysis was performed and shown in local currency units (PLN). RESULTS: The cath lab costs were higher in STEMI (4295.01 ± 2384.54PLN, p < 0.001) compared to NSTEMI (3493.40 ± 1907.43 PLN, p < 0.001), UA (3206.31 ± 1692.82 PLN, p < 0.001) and SA patients (3138.91 ± 1427.62 PLN, p < 0.001). They were higher in males than in females (3668.9 ± 2095.2 vs. 3292.0 ± 1656.0 PLN, p < 0.05). In females PCIs performed via radial approach were more expensive than via femoral approach (3360.4 ± 1540.1 vs. 3135.5 ± 1890.3 PLN, p < 0.01). In all subgroups analysed, costs were positively correlated with X-ray dose, fluoroscopy, and total procedure times. Patients' age negatively correlated with cath lab costs in STEMI/NSTEMI patients. CONCLUSIONS: Cath lab costs were higher in STEMI patients compared to other groups. In STEMI/NSTEMI they were lower in older patients. In all analysed groups costs were related to the level of procedural difficulty. In female patients, the costs of PCI performed via radial approach were higher compared to femoral approach. Despite younger age, male patients underwent more expensive procedures.

Evaluation of radiological risk during coronary angioplasty procedures: comparison of transradial and transfemoral approaches.

Increasing operator experience and newer available interventional cardiology devices require reassessment of radiological risk related to percutaneous coronary interventions (PCI). We aimed at comparison of radiological risk and procedural data of PCIs performed by radial (RA) and femoral (FA) approach in real life patients. Detailed retrospective analysis of 1500 consecutive PCIs with the use of radial or femoral access was performed. Comparison between RA and FA groups included procedural time (PT), fluoroscopy time (FT), radiation dose and contrast volume usage. There was no significant differences between RA and FA procedures in FT (12.6 ± 13.5 vs. 11.7 ± 9.5 min), X-ray dose generated during PCI (805.9 ± 615.9 vs. 792.2 ± 633.9 mGy) and use of contrast medium (145.2 ± 62.2 vs. 152.5 ± 64.2 ml). Mean total PT was shorter in RA (43.7 ± 24.5 min) than in FA group (47.2 ± 30.13 min, p < 0.02). Patients' age positively correlated with FT (r = 0.14, p < 0.05) and PT (r = 0.07, p < 0.05) in RA but not in FA group (r = 0.05; r = -0.06, respectively). Despite younger age, PCIs in males needed higher usage of contrast medium (151.7 ± 69.2 vs. 139.1 ± 49.3 ml; p < 0.001), and higher X-ray dose (887.0 ± 660.4 vs. 657.8 ± 515.2 mGy; p < 0.001). Age significantly correlated with PT only in female (r = 0.093, p < 0.05) but not in male patients (r = 0.015). We conclude that fluoroscopy times, X-ray dose and use of contrast medium were similar in RA and FA, but mean total procedural time was significantly shorter in RA than in FA group. However, older patients in RA group needed longer fluoroscopy and procedural times to complete PCI and this was not seen in FA.

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.

Bipolar irrigated radiofrequency ablation of resistant ventricular tachycardia with a septal intramural origin: the initial experience and a description of the method.

Bipolar radiofrequency (RF) ablation is effective in treatment of ventricular tachycardia originating from thick interventricular septum. The RF generator and CARTO system can be used to precisely and safely perform ablation. Standard ablation catheter can be used with indifferent ablation electrode connected to the electrode receptacle in RF generator with custom-made cable.

Coronary sinus-based percutaneous annuloplasty as treatment for functional mitral regurgitation: the TITAN II trial.

OBJECTIVE: Functional (or secondary) mitral regurgitation (FMR) is associated with greater morbidity and worse outcomes in patients with congestive heart failure (CHF) and cardiomyopathy. The Carillon® Mitral Contour System® is a coronary sinus-based percutaneous therapy to reduce FMR. We evaluated the safety and efficacy of a modified version of the Carillon device in the treatment of patients with cardiomyopathy and FMR. METHODS: 36 patients with CHF, depressed left ventricular function (ejection fraction <40%) and at least moderate FMR underwent the Carillon device implant. RESULTS: There was 1 major adverse event within 30 days-a death (not device related)-occurring 17 days after the implant. Reductions in FMR and improvements in functional class and 6 min walk tests were seen, similar to prior studies. Device fractures in the high strain region of the proximal anchor (seen in prior studies) were not seen in this study. CONCLUSIONS: The modified Carillon device was associated with improvements in clinical and echocardiographic parameters in treating patients with FMR, while successfully addressing the issue of anchor fracture. This version of the Carillon device will be used in a blinded randomised trial of symptomatic patients with FMR.

Stent loss in the radial artery - surgical vs. interventional approach - report of two cases.

Stent loss during coronary angioplasty is a complication that can be managed in various manners; however, transradial access limits the options available. We describe two coronary interventions complicated by stent dislodgement, initially managed by pulling the stent back to the radial artery. Both stents were unwillingly lost on different levels in radial arteries. The first case was managed with a direct radial artery cut-down because distal location made it a quick and straightforward procedure. In the second case a partially deployed stent was lost in the proximal part of the radial artery. It was rewired, deployed, and post-dilated with a larger balloon. This enabled continuation of the procedure using the same access. Both cases were asymptomatic during 24 months of follow-up. It is crucial to avoid leaving artificial bodies in arteries supplying vital organs because stent-related thrombosis or stenosis may seriously compromise blood flow. Removing the stent via the introducer sheath should be considered the optimal treatment. Unfortunately it is common that a partially expanded stent will not pass through the sheath. The superficial location of the distal radial artery segment facilitates surgical cut-down with local anaesthesia. When dislodgement occurs in deeper segments of the radial artery, the benefits from cut-down seem to be less because the procedure might take more time and be more difficult - as in the presented case in which we decided to rewire and fully expand the stent in situ. Retrieval of the stent at all costs might have led to further complications; hence stent deployment may be a good alternative to retrieval in such cases.

Transseptal puncture from the jugular vein and balloon cryoablation for atrial fibrillation in a patient with azygos continuation of an interrupted inferior vena cava.

AIMS: Inferior vena cava (IVC) interruption is a rare anatomic variant where the azygos vein (AV) drains the blood from the IVC to the upper part of the right atrium via the superior vena cava. Here, we report balloon cryoablation of the pulmonary veins (PVs) via superior access in a patient with atrial fibrillation. METHODS AND RESULTS: After the first failed ablation attempt due to IVC interruption, balloon cryoablation with a 28-mm Arctic Front Advance cryoballoon (Medtronic CryoCath LP, Quebec, Canada) via superior access was performed; it requires only a single transseptal puncture (TP), and the patient had optimal PV anatomy. Deflectable electrodes were inserted into the right ventricle and coronary sinus from the right femoral vein. The right internal jugular vein was accessed using an SL0 transseptal sheath and BRK needle. The TP was performed under transoesophageal echocardiographic guidance with a Safe Sept wire because the septum was stiff. All PVs were engaged: the left using an ablation catheter before balloon insertion and the inferior following a 'push-up' technique because of a leak above the veins. Cryothermal energy was delivered after checking for occlusion. The procedure lasted 210 min, fluoroscopy time was 78 min, and air-kerma dose was 194 mGy. During the 6-month follow-up, no episodes of atrial fibrillation were detected on several Holter recordings. CONCLUSIONS: Successful PV isolation in patients with AV continuation of an interrupted IVC can be safely performed using superior access with balloon cryoablation, after several modifications of standard equipment.

3D heart model printing for preparation of percutaneous structural interventions: description of the technology and case report.

BACKGROUND: Structural heart disease, including valvular disease as well as congenital defects, causes important alterations in heart anatomy. As a result, individualised planning for both surgical and percutaneous procedures is crucial for procedural optimisation. Three dimensional (3D) rapid prototyping techniques are being utilised to aid operators in planning structural heart procedures. AIM: We intend to provide a description of 3D printing as a clinically applicable heart modelling technology for the planning of percutaneous structural heart procedures as well as to report our first clinical use of a 3D printed patient-specific heart model in preparation for a percutaneous mitral annuloplasty using the Mitralign percutaneous annuloplasty system. METHODS: Retrospectively gated, contrast enhanced, multi-slice computed tomography (MSCT) scans were obtained. MSCT DICOM data was analysed using software that creates 3D surface files of the blood volume of specific regions of interest in the heart. The surface files are rendered using a software package that creates a solid model that can be printed using commercially available stereolithography machines. RESULTS: The technique of direct percutaneous mitral annuloplasty requires advancement of a guiding catheter through the aorta, into the left ventricle, and requires the positioning of the tip of the catheter between the papillary muscles in close proximity to the mitral annulus. The 3D heart model was used to create a procedural plan to optimise potential device implantation. The size of the deflectable guiding catheter was selected on the basis of the patient's heart model. Target locations for annulus crossing wires were evaluated pre-procedurally using the individual patient's 3D heart model. In addition, the ability to position the Bident Catheter at the appropriate locations under the mitral annulus as well as the manoeuvrability between the papillary muscles were analysed on the heart model, enabling safe completion of the procedure, which resulted in a significant reduction in mitral regurgitation. CONCLUSIONS: 3D printing is a helpful tool in individualised planning for percutaneous structural interventions. Future studies are warranted to assess its role in preparing for percutaneous and surgical heart procedures.

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.

Percutaneous direct mitral annuloplasty using the Mitralign Bident system: description of the method and a case report.

BACKGROUND: Functional mitral regurgitation (FMR) is known to contribute to a poor prognosis in patients with heart failure (HF). Current guidelines do not recommend cardiac surgery in patients with FMR and impaired ejection fraction due to the high procedural risk. Percutaneous techniques aimed at mitral valve repair may constitute an alternative to currently used routine medical treatment. AIM: To provide a description of a novel percutaneous suture-based technique of direct mitral annuloplasty using the Mitralign Bident system, as well as report our first case successfully treated with this method. METHODS: A deflectable guiding catheter is advanced via the femoral route across the aortic valve to the posterior wall of the ventricle. A nested deflectable catheter is advanced through the guide toward the mitral annulus that allows the advancement of an insulated radiofrequency wire to cross the annulus. The wire is directed across the annulus in a target area that is 2-5 mm from the base of the leaflet into the annulus, as assessed by real-time 3D transoesophageal echocardiography. After placement of the first wire, another wire is positioned using a duel lumen bident delivery catheter, which provides a predetermined separation between wires (i.e. 14, 17 or 21 mm). Each wire provides a guide rail for implantation of sutured pledget implants within the annulus. Two pairs of pledgets are implanted, one pair in each of the P1 and P3 scallop regions of the posterior mitral annulus. A dedicated plication lock device is used to provide a means for plication of the annulus within each pair of the pledgets, and to retain the plication by delivering a suture locking implant. The plications result in improved leaflet coaptation and a reduction of the regurgitant orifice area. RESULTS: A 60-year-old female with diagnosed dilated cardiomyopathy, concomitant FMR class III and congestive HF was successfully treated with the Mitralign Bident system. Two pairs of pledgets were implanted resulting in an improvement of transoesophageal echocardiographic parameters, including proximal isovelocity surface area radius (0.7 cm to 0.4 cm), effective regurgitant orfice area (0.3 cm² to 0.1 cm²) and mitral regurgitant volume (49 mL to 10 mL). CONCLUSIONS: Percutaneous mitral annuloplasty with the Mitralign Bident system is feasible. Future clinical trials are needed to assess its safety and efficacy.