Role of diabetes in heart rhythm disorders.

The incidence of diabetes mellitus (DM) is increasing rapidly. DM is the leading cause of cardiovascular diseases, which can lead to varied cardiovascular complications by aggravated atherosclerosis in large arteries and coronary atherosclerosis, thereby grows the risk for macro and microangiopathy such as myocardial infarction, stroke, limb loss and retinopathy. Moreover diabetes is one of the strongest and independent risk factor for cardiovascular morbidity and mortality, which is associated frequently with rhythm disorders such as atrial fibrillation (AF) and ventricular arrhythmias (VA). The present article provides a concise overview of the association between DM and rhythm disorders such as AF and VA with underlying pathophysiological mechanisms.

How should I treat a challenging case of MitraClip implantation?

BACKGROUND: A 71-year-old woman affected by idiopathic dilated cardiomyopathy with normal coronary arteries and permanent atrial fibrillation was found to have severe mitral regurgitation at transthoracic echocardiography (TTE), due to annular dilatation and restricted motion of the posterior leaflet. Because of poor quality of life, high functional class (NYHA Class III) and the high risk of surgery, the patient agreed to undergo the implantation of a MitraClip device. During the procedure, the transoesophageal echocardiographic (TEE) images were of a poor quality since the view of the mitral valve in the mid-oesophageal and transgastric projections did not accurately show the valve leaflets and the convergence area of the regurgitation at colour Doppler, which is indispensable for the correct positioning of the clip. INVESTIGATION: Physical examination, transthoracic echocardiography, transoesophageal echocardiography. DIAGNOSIS: Severe mitral regurgitation suitable for MitraClip implantation. MANAGEMENT: Transthoracic, and not transoesophageal, echocardiography approach during MitraClip procedure.

Surgical revision after percutaneous mitral valve repair by edge-to-edge device: when the strategy fails in the highest risk surgical population.

OBJECTIVES: Percutaneous edge-to-edge devices for non-surgical repair of mitral valve regurgitation are under clinical evaluation in high-risk patients deemed not suitable for conventional surgery. To address guidelines for initial therapy decision, we here report on 13 cases of surgery after failed percutaneous edge-to-edge mitral valve repair or attempted repair, and discuss methodology and prognostic factors for operative outcome in this high-risk situation. METHODS: Thirteen patients referred to our cardiothoracic unit after failed percutaneous mitral valve repair or attempted repair using the edge-to-edge technique, were treated surgically for mitral valve failure between June 2010 and December 2012. Pathology of mitral valve before and after interventional mitral valve repair (especially prevalent mode of failure) was evaluated and classified for each individual patient by echocardiography and intraoperative direct visualization. Number of implanted edge-to-edge devices were identified. Preoperative risk scores were matched with intraoperative observations and histopathological findings of valve tissue. Postoperative morbidity and mortality were analysed with respect to mitral valve and patient-related data. RESULTS: Three of 10 patients were referred with severe mitral valve regurgitation/stenosis after initially successful percutaneous edge-to-edge therapy or attempted therapy. In 3 patients, ≥ 2 edge-to-edge devices were implanted leading to very tight edge-to-edge leaflet connection and fibrosis. All patients underwent successful surgical mitral valve replacement and concomitant complete cardiac surgery (CABG, aortic or tricuspid valve surgery, ASD closure and pulmonary vein isolation for atrial fibrillation). The likelihood of repair was reduced with respect to multiple edge-to-edge technology. One device could not be harvested surgically because of embolization. One patient died on the second postoperative day due to sepsis with multiple organ failure. The remaining 12 patients were discharged with excellent valve prosthesis function and followed up to 2 years post-surgery. The current long-term survival rate is 77%. CONCLUSION: Our series demonstrate that highest risk patients can survive mitral valve surgery after failed multiple edge-to-edge interventional mitral valve repair. As long-term results of the MitraClip therapy are pending, we recommend close meshed follow-up of patients treated with the MitraClip device, especially within the first year of the index procedure as delays in salvage management, interventional or surgical, when the index procedure fails may increase morbidity and mortality.

Percutaneous mitral repair with the MitraClip system in patients with mild-to-moderate and severe heart failure: a single-centre experience.

AIMS: Edge-to-edge repair of mitral regurgitation (MR) with the MitraClip(®) (MC) system is increasingly applied in advanced heart failure. Our objective was to compare outcomes in patients with mild-to-moderate and severe systolic heart failure. METHODS AND RESULTS: Between February 2010 and July 2012, 121 patients with MR of at least grade 3+ and a mean EuroSCORE II of 10.6% underwent MC implantation. Thirty-nine had a left ventricular ejection fraction (LVEF) of ≤30% (group A) and 82 of >30% (group B). Procedural success was comparable in both groups (100% vs. 95.2%) with multiple (>2) clip implantation in 34% and 25% of patients, respectively. At 12 months, absolute reduction in MR grade (2.3 vs. 2.2) and relative reduction in mitral valve orifice area (48% vs. 42%) were also comparable. New York Heart Association class had improved independent from baseline LVEF (P < 0.001). In-hospital mortality was low in both groups (2.6% vs. 2.4%), but there was a strong trend for higher 12-month mortality in group A (34% vs. 18%, P = 0.05) with no significant difference in the overall rate of major adverse cerebrovascular and cardiac events (36.8% vs. 28.9%, P = 0.38). On multivariate analysis, MR grade after repair was the strongest predictor of mortality (OR 2.121, 95% CI 1.095-4.109), whereas systolic impairment was no independent predictor. CONCLUSIONS: Percutaneous mitral valve repair led to comparable symptomatic improvement in patients with mild-to-moderately or severely reduced LV function. LV-EF < 30% was not an independent predictor of short-term mortality, which was mainly governed by residual MR after repair.

Transcatheter valve-in-ring implantation after a failed surgical mitral repair using a transseptal approach and a veno-arterial loop for valve placement.

A failure of a mitral valve repair, which includes the implantation of a mitral annuloplasty ring in the majority of cases, is associated with relevant mortality. Surgery is considered as the standard treatment for these patients. For patients who have an unacceptable high peri-surgical risk a transcatheter valve-in-ring (TVIR) procedure might be an option. Isolated case reports and small case series report on the feasibility of a TVIR implantation in mitral position. We present a case where a 29-mm Edwards Sapien valve was placed in a 32-mm Carpentier Edwards ring. To our knowledge no valve has been implanted so far in this ring size and this is the first case where a veno-arterial loop was used as guide rail for valve implantation and helped considerably to position the valve properly.

Parachute implant: CT morphological criteria of our center to identify the suitable patient.

AIMS: In this study, we present and discuss our institutionalized and standardized computed tomography (CT) morphological criteria for the treatment of patients with a parachute device. METHODS AND RESULTS: After clinical and echocardiographic screening of 79 patients with ischemic heart failure, 28 were examined using multidetector computed tomography (MDCT) to assess their suitability for treatment with a parachute implant. From the 28 examined patients, nine were suitable for parachute implantation. Within the group of excluded patients, the cardiac diameters of one-third of the patients were too large, whereas for another third they were too small. Approximately 20% of the patients were rejected because of a deep insertion of the papillary muscles. Further reasons included left ventricular bands as well as mismatches between CT and echocardiographic measurements of left ventricular ejection fraction (LVEF). CONCLUSIONS: To ensure a safe parachute device implantation in patients with ischemic heart failure, only the CT at present offers the capability to obtain complete and dynamic three-dimensional (3D) measurements of the cardiac dimensions.

Challenges in patient selection for the parachute device implantation.

BACKGROUND: A novel percutaneous ventricular restoration therapy (PVRT) has been recently proposed to treat patients with ischemic heart failure (IHF) and antero-apical regional wall motion abnormalities after myocardial infarction (MI). In this prospective, single center, non-randomized study, we herein propose safety and feasibility evaluation of the device, in which a different patient selection strategy was used. MATERIAL AND METHODS: A three-stage evaluation was adopted in a series of patients referred for a Parachute Ventricular Partitioning Device (Parachute™). After an initial clinical evaluation, a secondary screening step was performed according to echocardiographic functional (LVEF<40%, apical/anterior akinesia/dyskinesia) and anatomical criteria [diameter of LV-apex (LVAD) = 4.0 × 5.0 cm, left ventricular end diastolic diameter (LVEDD)>56 mm, left ventricular end systolic diameter (LVESD)>38 mm]. Patients encountering the echocardiographic criteria were selected for 3D cardiac CT (architecture, geometry, and trabeculation of the left ventricle) and eventually treated with the Parachute™. RESULTS: Fifty patients were screened according to the echocardiographic criteria. Twenty-seven of those that met the echo inclusion criteria underwent further cardiac CT imaging. After CT imaging, eight patients were scheduled for Parachute™ implantation. The device was successfully implanted in all eight patients with no in-hospital mortality. A 3-month follow-up echocardiography showed LV-volume reduction [95% CI; LVEDV: -76.5 (-116; -36.8), P = 0.002 and LVESV: -47.4 (-63.8; -30.9), P = 0.003] and improvement of global EF [95% CI; global EF: 6.87 (5.36; 8.39), P = 0.008]. CONCLUSION: Selection criteria for Parachute™ placement should include left ventricular functional and anatomical parameters. When preprocedural echocardiography and cardiac CT are adequately implemented, satisfactory periprocedural and short term follow-up results may be achieved after Parachute™ implantation.

Mitral valve repair using multiple MitraClips®: a dobutamine stress echocardiography evaluation.

AIMS: The haemodynamic effect of mitral valve (MV) repair using multiple MitraClips® (MC) has not been investigated. The aim of the study was to evaluate the stress performance of MV repair with MC. METHODS AND RESULTS: Twenty consecutive patients (77±7 years, 13 men [65%]) after implantation of >2 MitraClips® were subsequently evaluated with dobutamine stress echocardiography (DSE). After MC implantation, mean transmitral pressure gradient (TPG) (3.3±0.8 mmHg vs. 4.0±0.6 mmHg; p<0.001) and mitral valve orifice area (2.9±0.3 cm2 vs. 3.9±0.4 cm2; p<0.001) were significantly increased during DSE showing a physiological behaviour effect of the MV. LVEF (41±18% vs. 46±21%; p<0.001) and systolic pulmonary artery pressure (42±11 mmHg vs. 44±12 mmHg; p=0.014) increased significantly. The degree of MR was stable during stress (p=0.68). At linear regression, only baseline peak TPG was related to stress mean TPG (p<0.001; Beta 0.816; 95% CI: 0.368-0.918). CONCLUSIONS: MV repair using MitraClips® should be performed with the aim of maximal reduction of MR degree. MV repair using MC may not lead to pathological degrees of MV stenosis. Although the TPG is significantly increased during stress, it never reaches pathological levels and is always accompanied by a significant increase in MVOA. The degree of residual MR remains unchanged during maximal pharmacological stress.

Residual mitral valve regurgitation after percutaneous mitral valve repair with the MitraClip® system is a risk factor for adverse one-year outcome.

OBJECTIVES: We undertook this study to investigate the mid-term clinical results after MitraClip® implantation and the impact of post-repair mitral valve (MV) function and anatomy on survival and outcome composite endpoint in high-risk patients. BACKGROUND: Percutaneous MV repair is a potential treatment option for high-risk patients with severe mitral regurgitation (MR). METHODS: MitraClip® was implanted in patients with symptomatic MR rejected to conventional surgery. Differences between patients that survived at follow-up and patients deceased were tested. A stepwise Cox multivariate analysis was performed to identify independent predictors for composite endpoint of mortality, cardiac re-hospitalization, re-intervention, and major cerebro-vascular and cardiac events. RESULTS: A total of 85 consecutive patients [78 ± 6 years, 48 (56.5%) men] with severe MR were included. There was no operative mortality while in-hospital mortality was 3.5% (n = 3) and 30-day mortality 4.7% (n = 4). Follow-up was 211 ± 173 days. Survival and composite endpoint-free survival at one year were 71% and 55%. Multivariate analysis revealed that residual MR immediately after MitraClip® placement (OR 7.4; 95% CI 2.3-23.7) and preoperative MV gradient (OR 2.7; 95% CI 1.5-5.0) were predictors for composite endpoint. Chronic obstructive pulmonary disease (OR 8.3; 95% CI 1.9-37.1) was an additional predictor for composite endpoint. CONCLUSION: MitraClip® is a valid tool with favorable outcomes in high-risk patients. The degree of residual MR seems to impact on follow-up composite endpoint outcome. An optimal correction of MR after MitraClip placement could be advocated to optimize the benefits of the procedure and minimize the risk of adverse outcomes.

Percutaneous mitral valve repair with the MitraClip system: perioperative and 1-year follow-up results using standard or multiple clipping strategy.

OBJECTIVES: The purpose of this study was to compare outcomes using standard clipping (SC) (one to two clips) or multiple clipping (MC) (more than two clips). BACKGROUND: MitraClip implantation using MC has been proposed to treat severe mitral regurgitation (MR) in high-risk patients. METHODS AND RESULTS: A tailored strategy was used implanting as many clips as required to eliminate MR. A total of 85 consecutive patients [78 ± 6 years, 48 men (56.5%) ] with MR (grade 3+ or 4+) were included. EuroSCORE was 24 ± 12 (2.5-56.3) and STS-score 12 ± 7 (1.2-31.2). SC was used in 61 (71.8%) and MC in 24 (28.2%) patients. Patients in MC group had larger mitral valve (MV) annuli (P = 0.025), MV orifice areas (MVOA) (P = 0.01), and MR degree (P = 0.005). Successful clip placement was achieved in 82 patients (96.5%). At discharge, no patient had grade 4+ MR. MR 3+ presented in 4 patients (7.0%) in the SC group and in 1 (4.5%) in the MC group (P = 0.72). There were 3 (3.5%) in-hospital deaths. Follow up (211 ± 173 days, range 4-652) echocardiography confirmed similar MVOA (P = 0.83) and MV gradients (P = 0.54) in the both groups. At linear regression there was no independent correlation between clips number and postoperative MVOA/gradient. One-year survival was 71.1% without difference between groups (P = 0.74). CONCLUSION: Although the hemodynamic and anatomical basis of MR may differ, every procedure should aim at eliminating MR. In some patients this goal can be achieved using MC with minimized risk of MV stenosis if preoperative anatomy/mechanism of MV regurgitation are adequately assessed.

Combined use of rapid pacing and adenosine facilitates catheter based correction of severe bileaflet prolapse with the MitraClip system.

The results of the Endovascular Valve Edge-to-Edge Repair Study (EVEREST) II trial have demonstrated that percutaneous mitral valve repair using the MitraClip in high-risk patients was associated favourable outcomes. However, commonly accepted contraindications for the standard MitraClip procedure include extensively prolapsed valves and flail leaflets. We report on the management of a patient not amenable to standard interventional procedure.

Percutaneous vs surgical repair of mitral valve regurgitation: single institution early and midterm outcomes.

BACKGROUND: The objective of this study was to compare outcomes of surgical repair (SR) vs MitraClip (MC) implantation for severe mitral regurgitation (MR). METHODS: A retrospective analysis of patients treated within a single institution was performed. Patients had EuroSCORE [European System for Cardiac Operative Risk Evaluation] < 20%, left ventricular ejection fraction ≥45%, and grade 3+/4+ MR. RESULTS: Fifty patients (24 [48%] MC group, 26 [52%] SR group) with EuroSCORE 7.9 ± 5.6 were included. The MC group included 24 (48%) and the SR group 26 (52%) patients. Patients in the MC group had a significantly more complex comorbid profile (P < 0.001). Successful MC placement was in 22 patients (91.7%) and SR in 26 (100%). At discharge, no patient had grade 3+/4+ MR. There were no in hospital or 30-day deaths. At follow-up (mean 526 ± 398 days), further mitral valve surgery was necessary in 1 (3.8%) patient in the SR group and in 2 (8.3%) patients in the MC group (P = 0.26). One-year freedom from composite end point (death, stroke, myocardial infarction, major bleeding, cardiac rehospitalization) was 75.5% (SR 83% vs MC 67%; P = 0.18). Degree of residual MR Degree of residual MR immediately after the procedure was equally distributed in both groups (P = 0.13) and the sole independent determinant for composite outcome (odds ratio, 16.9; P = 0.024). CONCLUSIONS: MC in nonsurgical candidates and SR in surgical patients showed similar perioperative and follow-up outcomes at an institution experienced with both techniques. Neither MC nor SR were independently related to outcome whenever similar degrees of acute correction with minimal residual MR were achieved. However, these findings should be interpreted within the selection biases and the numerical limitations of the present study.

Predictive factors for pacemaker requirement after transcatheter aortic valve implantation.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has been established as a treatment option for inoperable patients with symptomatic aortic valve stenosis. However, patients suffer frequently from conduction disturbances after TAVI. METHODS: Baseline, procedural as well as surface and intracardiac ECG parameters were evaluated for patients treated with TAVI and a comparison between patients requiring pacemaker with those not suffering from relevant conduction disorders were done. RESULTS: TAVI was successfully in all patients (n=45). Baseline surface and intracardiac ECG recording revealed longer PQ (197.1±51.2 msec versus 154.1±32.1 msec; p<0.001), longer AH (153.6±43.4 msec versus 116.1±31.2 msec; p<0.001) and HV interval (81.7±17.8 msec versus 56.8±8.5 msec; p<0.001) in patients with need for a pacemaker (n=23) versus control group (n=22); furthermore, 7-day follow-up analysis showed a higher prevalence of new left bundle branch block (LBBB) (87.0% versus 31.9%; p<0.001). Multivariate analysis revealed that only new LBBB, QRS duration >120 msec and a PQ interval >200 msec immediately (within 60 minutes) after implantation of the aortic valve were predictors for high-grade (type II second-degree and third-degree) AV block. Other clinical parameters as well as baseline electrocardiographic parameters had no impact on critical conduction delay. CONCLUSION: Cardiac conduction disturbances are common after TAVI. The need for pacing after TAVI is predictable by surface ECG evaluation immediately (within 60 minutes) after the procedure.

Morbidity and mortality of nonagenarians undergoing CoreValve implantation.

BACKGROUND: Nonagenarians are mostly denied from different therapeutic strategies due to high comorbidity index and risk-benefit calculation. We present the results of nonagenarians with high comorbidity index not eligible for conventional aortic valve surgery undergoing transcatheter aortic valve implantation (TAVI) with the CoreValve system. METHODS: Our retrospective analysis include baseline parameters, procedural characteristics, morbidity, mortality as well as twelve-lead surface ECG and echocardiographic parameters which were revealed preinterventionally, at hospital discharge and at 30-day follow-up. Clinical follow-up was performed 6 months after TAVI. RESULTS: Out of 158 patients 11 nonagenarians with a mean age of 92.6 ± 1.3 years suffering from severe aortic valve stenosis and elevated comorbidity index (logistic EuroSCORE of 32.0 ± 9.5%, STS score 25.3 ± 9.7%) underwent TAVI between January 2008 and January 2011 using the third-generation percutaneous self-expanding CoreValve prosthesis. Baseline transthoracic echocardiography reported a mean aortic valve area (AVA) of 0.6 ± 0.2 cm(2) with a mean and peak pressure gradient of 60.2 ± 13.1 mmHg and 91.0 ± 27.4 mmHg, respectively. The 30-day follow up all cause and cardiovascular mortality was 27.3% and 9.1%, respectively. One major stroke (9.1%), 2 pulmonary embolisms (18.2%), 1 periprocedural (9.1%) and 1 (9.1%) spontaneous myocardial infarction occured. Life-threatening or disabling bleeding occurred in 2 cases (18.2%), and minor bleeding in 7 cases (63.6%). Mean severity of heart failure according to NYHA functional class improved from 3.2 ± 0.8 to 1.36 ± 0.5 while mean AVA increased from 0.6 ± 0.2 cm(2) to 1.8 ± 0.2 cm(2). At 6-months follow-up 8 patients (72.7%) were alive without any additional myocardial infarction, pulmonary embolism, bleeding, or stroke as compared to 30-day follow-up. CONCLUSION: Our case series demonstrate that even with elevated comorbidity index, clinical endpoints and valve-associated results are relatively favorable in nonagenarians treated with CoreValve.

Early and mid-term outcomes of percutaneous mitral valve repair with the MitraClip®: comparative analysis of different EuroSCORE strata.

AIMS: Compare mid-term outcomes after MitraClip® implantation for severe mitral regurgitation (MR) in patients categorised in different logistic EuroSCORE (LES) groups. METHODS AND RESULTS: MitraClip was implanted in 85 patients (78 ± 6 years, 48 men [56.5%]) with severe symptomatic MR. Baseline characteristics, perioperative results, mid-term survival, major adverse cerebrovascular and cardiac events (MACCE), and re-hospitalisation were compared in patients with LES <20% (n=30) and ≥ 20% (n=55). Overall LES was 24 ± 12 (range 2.5-56.3) and STS-score 12 ± 7 (range 1.2-31.2). Overall procedural success rate was 96.5% with an in-hospital mortality rate of 3.5%. Echocardiographic and clinical follow-up confirmed similar mean transmitral pressure gradient (p=0.13), MR degree (p=0.48), and NYHA Class (p=0.93). Estimated six-month survival and freedom from composite endpoint was 80.7%/77.1% in LES ≥ 20% and 90.8/86.6% in LES<20% group, respectively (p= 0.014; p=0.018). Multivariate analysis determined LES ≥ 20% (OR=8.1; 95% CI 1.002-65.186), mean transmitral gradient after intervention (OR 2.5; 95% CI 1.267-5.131) and residual MR (OR=5.1; 95% CI 1.464-17.946) as predictors for overall mortality. CONCLUSIONS: LES is a good predictor of perioperative results, and follow-up adverse outcomes after MitraClip implantation are significantly influenced by the preoperative risk profile. The presence of residual MR immediately after MitraClip therapy can exacerbate the occurrence of MACCE.

Correlation between the functional impairment of bone marrow-derived circulating progenitor cells and the extend of coronary artery disease.

BACKGROUND: Bone marrow-derived circulating progenitor cells (BM-CPCs) in patients with coronary heart disease are impaired with respect to number and functional activity. However, the relation between the functional activity of BM-CPCs and the number of diseased coronary arteries is yet not known. We analyzed the influence of the number of diseased coronary arteries on the functional activity of BM-CPCs in peripheral blood (PB) in patients with ischemic heart disease (IHD). METHODS: The functional activity of BM-CPCs was measured by migration assay and colony forming unit in 120 patients with coronary 1 vessel (IHD1, n = 40), coronary 2 vessel (IHD2, n = 40), coronary 3 vessel disease (IHD3, n = 40) and in a control group of healthy subjects (n = 40). There was no significant difference of the total number of cardiovascular risk factors between IHD groups, beside diabetes mellitus (DM), which was significantly higher in IHD3 group compared to IHD2 and IHD1. RESULTS: The colony-forming capacity (CFU-E: p < 0.001, CFU-GM: p < 0.001) and migratory response to stromal cell-derived factor 1 (SDF-1: p < 0.001) as well as vascular endothelial growth factor (VEGF: p < 0001) of BM-CPCs were reduced in the group of patients with IHD compared to control group. The functional activity of BM-CPCs was significantly impaired in patients with IHD3 as compared to IHD1 (VEGF: p < 0.01, SDF-1: p < 0.001; CFU-E: p < 0.001, CFU-GM: p < 0.001) and to IHD2 (VEGF: p = 0.003, SDF-1: p = 0.003; CFU-E: p = 0.001, CFU-GM: p = 0.001). No significant differences were observed in functional activity of BM-CPCs between patients with IHD2 and IHD1 (VEGF: p = 0.8, SDF-1: p = 0.9; CFU-E: p = 0.1, CFU-GM: p = 0.1). Interestingly, the levels of haemoglobin AIc (HbAIc) correlated inversely with the functional activity of BM-CPCs (VEGF: p < 0.001, r = -0.8 SDF-1: p < 0.001, r = -0.8; CFU-E: p = 0.001, r = -0.7, CFU-GM: p = 0.001, r = -0.6) in IHD patients with DM. CONCLUSIONS: The functional activity of BM-CPCs in PB is impaired in patients with IHD. This impairment increases with the number of diseased coronary arteries. Moreover, the regenerative capacity of BM-CPCs in ischemic tissue further declines in IHD patients with DM. Furthermore, monitoring the level of BM-CPCs in PB may provide new insights in patients with IHD.

Intra coronary freshly isolated bone marrow cells transplantation improve cardiac function in patients with ischemic heart disease.

BACKGROUND: Autologous bone marrow cell transplantation (BMCs-Tx) is a promising novel option for treatment of cardiovascular disease. In this study we analyzed whether intracoronary autologous freshly isolated BMCs-Tx have beneficial effects on cardiac function in patients with ischemic heart disease (IHD). RESULTS: In this prospective nonrandomized study we treated 12 patients with IHD by freshly isolated BMCs-Tx by use of point of care system and compared them with a representative 12 control group without cell therapy. Global ejection fraction (EF) and infarct size area were determined by left ventriculography.Intracoronary transplantation of autologous freshly isolated BMCs led to a significant reduction of infarct size (p < 0.001) and an increase of global EF (p = 0.003) as well as infarct wall movement velocity (p < 0.001) after 6 months follow-up compared to control group. In control group there were no significant differences of global EF, infarct size and infarct wall movement velocity between baseline and 6 months after coronary angiography. Furthermore, we found significant decrease in New York Heart Association (NYHA) as well as significant decrease of B-type natriuretic peptide (BNP) level 6 months after intracoronary cell therapy (p < 0.001), whereas there were no significant differences in control group 6 months after coronary angiography. CONCLUSIONS: These results demonstrate that intracoronary transplantation of autologous freshly isolated BMCs by use of point of care system is safe and may lead to improvement of cardiac function in patients with IHD. REGISTRATION NUMBER: ISRCTN54510226.