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.

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.

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.

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.

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.

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 myoblasts for myocardial regeneration.

We overview the current knowledge about the use of skeletal myoblasts in regeneration of infarcted myocardium. Myoblasts are attractive candidates for cell source for cardiomyoplasty in chronic postmyocardial injury as indicated by experimental and initial clinical experience. We also review the recent developments in skeletal myoblasts transplantation techniques with special attention to percutaneous transvenous approach to deliver therapeutic agents into myocardium from the lumen of coronary veins under intravascular guidance.

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.