Clinical outcomes of conventional surgery versus MitraClip® therapy for moderate to severe symptomatic mitral valve regurgitation in the elderly population: an institutional experience.

BACKGROUND: The aim of this study was to compare treatment of moderate to severe symptomatic mitral regurgitation (MR) with either conventional surgery or the mitral valve edge-to-edge device (MitraClip®) in very elderly patients. The newly introduced MitraClip device has demonstrated promising acute results in treating this patient cohort. Also noteworthy is the fact that patients who otherwise would have been denied surgery are increasingly referred for treatment with the MitraClip device. We sought to review our institutional experience, comparing outcomes in both surgical and MitraClip arms of treatment in the elderly population with symptomatic MR. METHODS: From October 2008 through October 2014, 136 consecutive patients aged ≥ 80 with moderate to severe symptomatic MR were scheduled for either conventional surgery or MitraClip intervention. 56 patients ≥ 80 were operated for symptomatic MR and 80 patients ≥ 80 were treated with the mitraClip device. Patients suitable for this study were identified from our hospital database. Patients ≥80 with moderate/severe symptomatic MR treated with either conventional surgery or the MitraClip device were eligible for our analysis. We compared the surgical patient cohort with the mitraClip patient cohort after eliminating patients that did not meet our inclusion criteria. Forty-two patients were identified from the conventional cohort who were then compared with 42 patients from the mitraClip cohort. Forty-two patients (50%) underwent mitral valve repair or replacement (40.5% functional MR, 59.5% organic/mixed MR) and 42 patients (50%) underwent MitraClip intervention (50% functional MR, 50% organic/mixed MR). Associated procedures in the conventional surgical group were myocardial revascularization 38%, pulmonary vein ablation 23.8%, left atrial appendage resection 52.4% and PFO occlusion 11.9%. RESULTS: Patients who underwent MitraClip treatment were though slightly older but the differences did not attain statistical significance (mean, 82.2 ± 1.65 vs 81.7 ± 1.35 years, p = 0,100), had lower LVEF (mean, 47.6 ± 14.2 vs 53.4 ± 14.3, p = 0.072), lower logistic EuroScore II (mean, 11.3 ± 5.63 vs 12.1 ± 10.6, p = 0.655) but higher STS risk score (mean, 11.8 ± 6.7 vs 8.1 ± 5.6, p = 0.008) respectively compared to surgical patients. Procedural success was 100% vs 96% in surgery and MitraClip groups respectively. Thirty -day mortality was 7.1% vs 4.8% (p = 1.000) in surgery and MitraClip group respectively. Residual postoperative MR ≥2 at discharge was present in none of the patients treated surgically, whereas this was the case in 10 (23.8%) patients treated with the MitraClip device. At 1 year a cumulative number of four (9.52%) patients died in the surgical group vs 9 (21.4%) patients who died in the MitraClip group. CONCLUSIONS: Elderly patients presenting with moderate to severe symptomatic MR may either be treated by conventional surgery or with the MitraClip device with acceptable acute outcomes. The decision for treatment with the MitraClip device should not depend on age alone rather on cumulative risk of conventional surgery. Concomitant cardiac pathologies, often times treated simultaneously during surgery for symptomatic MR may be omitted, if patients are scheduled outright to MitraClip treatment. The effect of concomitant cardiac pathologies left untreated at the time of interventional mitral valve repair on outcome after MitraClip therapy remain widely unknown.

Conventional Surgery for Early and Late Symptomatic Mitral Valve Stenosis After MitraClip® Intervention: An Institutional Experience With Four Consecutive Patients.

BACKGROUND: Surgical mitral valve repair is the gold standard for treatment of mitral regurgitation. Recently, the transcatheter treatment of mitral regurgitation with the MitraClip® device (Abbot Vascular Structural Heart, Menlo Park, CA) has demonstrated promising results in treating patients not amenable for surgical correction of mitral valve regurgitation. Most patients reported in the literature requiring surgical bailout after MitraClip treatment presented with residual or recurrent mitral valve regurgitation. Mitral valve stenosis after MitraClip treatment has been rarely reported. METHODS: From February 2010 to December 2014, four patients out of 165 patients who underwent MitraClip therapy developed symptomatic mitral valve stenosis (2.4%) and needed surgical correction. Data of the four patients were reviewed retrospectively. Follow-up data were obtained from each patient's general practitioner/cardiologist by phone calls and facsimile and were complete in all patients. RESULTS: All four patients were treated with ≥ 2 MitraClip (MC) devices during their initial presentation. All four patients underwent MV replacement with a tissue valve. The postoperative course was uneventful and there was no 30-day mortality. At 6-month follow-up, all patients were alive and in NYHA class I-III. CONCLUSION: Placement of multiple clip devices may lead to slightly elevated transmitral gradients. This may not necessarily interpret into symptomatic mitral stenosis. However, in some cases this is possible. Caution should be exercised at this phase of the learning curve of the percutaneous MC treatment, especially in use of multiple MC devices.

Previous malignancy is an independent predictor of follow-up mortality after percutaneous treatment of mitral valve regurgitation by means of MitraClip.

AIMS: To investigate the prognostic burden of previously diagnosed and treated malignancies in candidates for percutaneous mitral valve repair (MVR) with MitraClip. METHODS AND RESULTS: A total of 165 patients underwent MVR and 19 (11.5%) had been previously treated for malignancy and considered healed with life expectancy over 1 year at time of percutaneous MVR. There was a significant trend for an increased overall risk profile (euroSCORE II 14.0±11.4 vs 10.0±6.7, P=.01) in patients with a previous diagnosis of neoplasia. Moreover, neoplastic patients had lower device success rates (78.9% vs 97.3%; P=.001), longer hospitalization (12.3±10.6 vs 7.5±4.9 days, P=.001), and higher 30-day mortality (10.5% vs 2.7%, P=.09). Kaplan-Meier overall estimated 1-, 2-, 3-, and 4-year survival of the overall cohort was 72%, 61%, 48%, and 44%, respectively. Estimated 1- and 2-year survival were 44.4% and 22.2 % in patients with previous neoplasia and 75.3% and 65% in the remaining patients (P<.0001). Median survival was 312 days in the neoplastic group (CI 95%: 182.6-441.4 days) and 1209 days in the remaining patients (CI 95%: 758.8-1659.2 days) (P<.0001). At Cox regression, the strongest determinant for mortality was an anamnesis for neoplasia (HR 2.4, 95% CI 1.4-4.3, P=.001). CONCLUSIONS: Previous neoplasm is a significant independent predictor of increased mortality after MVR with MitraClip. This association is even stronger than that of other cardiac and overall comorbidities and should be kept into consideration when referring patients for treatment.

Do gender differences in primary PCI mortality represent a different adherence to guideline recommended therapy? a multicenter observation.

BACKGROUND: It is uncertain whether gender differences in outcome after primary percutaneous coronary intervention (PCI) are only attributable to different baseline characteristics or additional factors. METHODS: Databases of two German myocardial infarction network registries were combined with a total of 1104 consecutive patients admitted with acute ST-elevation myocardial infarction (STEMI) and treated according to standardized protocols. RESULTS: Approximately 25% of patients were females. Mean age (69 vs 61 years), incidence of diabetes (28% vs 20%), hypertension (68 vs 58%) and renal insufficiency (26% vs 19%) was significantly higher compared to males. Mean prehospital delay was numerically longer in females (227 vs 209 min) as was in hospital delay (35 vs 30 min). PCI was finally performed in 92% of females and 95% of males with comparable procedural success (95% vs 97%). Use of drug eluting stents (55% vs 68%) and application of GP 2b 3a blockers (75% vs 89%) was significantly less frequent in women. At discharge, prescription of beta blockers and lipid lowering drugs was also significantly lower in females (84% vs 90% and 71% vs 84%). Unadjusted in-hospital mortality was significantly higher in females (10% vs 5%) without attenuation after 12 months. Adjusted mortality however did not differ significantly between genders. CONCLUSION: Higher unadjusted mortality in females after primary PCI was accompanied by significant differences in baseline characteristics, interventional approach and secondary prophylaxis in spite of the same standard of care. Lower guideline adherence seems to be less gender specific but rather a manifestation of the risk-treatment paradox.

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.

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.

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.

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.

Staged total percutaneous treatment of aortic valve pathology and mitral regurgitation: institutional experience.

OBJECTIVES: To summarize our single Institution experience with staged total percutaneous management of aorto-mitral pathology. BACKGROUND: Percutaneous treatment of aortic valve stenosis (AVS) and mitral valve regurgitation (MVR) has been recently proposed for patients at high surgical risk. METHODS: Data concerning consecutive patients undergoing percutaneous transcatheter AV implantation (TAVI) followed by MV repair with MitraClip® were prospectively collected and analyzed. RESULTS: From January 2010 to February 2012 a total of 254 patients were referred to undergo TAVI in our Institution. Seventeen (6.7%) had preoperative severe MVR that remained unchanged after TAVI. Due to exacerbation of symptoms 12 patients were subsequently submitted to MV repair with the MitraClip® device. Mean age was 79 years (72-86 years), median Ambler score was 30.1 (17.2-42.6) and EuroSCORE 22.3 (10.2-48.6). Procedural success rate was 100%. Postprocedural hospitalization was 7.1 ± 2.7 and 4.6 ± 0.9 days after TAVI and MV repair, respectively. Six months follow-up echocardiography confirms improvement in LV-EF (37.2 ± 9.9 vs. 43.5 ± 10.7, P < 0.0001). No patient presents MVR exceeding grade I(+) or prosthetic aortic insufficiency > I grade and all patients experienced an improvement in functional status. CONCLUSIONS: Percutaneous treatment of AVS and MVR is feasible and safe. A tailored approach should be considered to treat firstly the AVS and subsequently the MVR when severe MV dysfunction and symptoms persist. Short-term durability of this combined percutaneous approach seems encouraging and justifies the economical burden to treat patients that have no other option.

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.

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.

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.

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 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.

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.

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.

In-hospital outcome of patients with severe mitral valve regurgitation classified as inoperable and treated with the MitraClip® device.

BACKGROUND: To evaluate the short-term outcome of patients predominantly at high risk treated with the MitraClip® device for severe mitral valve regurgitation (MR) using one or more clips. METHODS: We prospectively analyzed patients with highly symptomatic MR classified as inoperable (logistic EuroSCORE 24.16 ± 13.64%; STS-score 29.9 ± 14.5%) but subject to mitral valve repair with MitraClip® between May 2010 and January 2011. Thirty-three consecutive patients (57.6% male; age 77.8 ± 6.7 years) were enrolled and treated with either 1 (n = 7; 21.2%), 2 (n = 20; 60.6%), 3 (n = 4; 12.1%), or 4 (n = 2, 6.1%) clips. Grading of MR was performed by two-dimensional transesophageal echocardiography (2D-TEE) prior to TEE-guided clipping and before discharge. RESULTS: MR was classified as functional in 23 (69.7%) and organic in 10 (30.3%) of the patients with MR-grade ≥ 3+ in 32 (97%) and = 4 in 1 patients (3%) before repair. Reduction in MR grade to grade ≤1+ was achieved in 81.7% and to 2 in 12.1% (P = 0.00072). Invasive pulmonary artery systolic pressure (PAPsyst) and pulmonary capillary wedge pressure (PCWP) v-wave decreased from 59.2 ± 18.6 to 46.9 ± 15.3 mmHg (P = 0.00014) and 21.2 ± 6.7 to 8.0 ± 3.3 mmHg (P = 0.0093), respectively, as measured immediately after clipping. Functional NYHA class improved from mean 3 (range 3 [90.9%] to 4 [9.1%]) to 2 in 84.9% (P = 0.00081) as obtained at discharge. CONCLUSIONS: Mitral valve repair with MitraClip® using multiple clips is appropriate and safe in unselected patients resulting in reduced MR with positive impact on short-term functional capacity.