Lack of "obesity paradox" in patients presenting with ST-segment elevation myocardial infarction including cardiogenic shock: a multicenter German network registry analysis.

BACKGROUND: Studies have associated obesity with better outcomes in comparison to non-obese patients after elective and emergency coronary revascularization. However, these findings might have been influenced by patient selection. Therefore we thought to look into the obesity paradox in a consecutive network STEMI population. METHODS: The database of two German myocardial infarction network registries were combined and data from a total of 890 consecutive patients admitted and treated for acute STEMI including cardiogenic shock and cardiopulmonary resuscitation according to standardized protocols were analyzed. Patients were categorized in normal weight (≤24.9 kg/m(2)), overweight (25-30 kg/m(2)) and obese (>30 kg/m(2)) according to BMI. RESULTS: Baseline clinical parameters revealed a higher comorbidity index for overweight and obese patients; 1-year follow-up comparison between varying groups revealed similar rates of all-cause death (9.1 % vs. 8.3 % vs. 6.2 %; p = 0.50), major adverse cardiac and cerebrovascular [MACCE (15.1 % vs. 13.4 % vs. 10.2 %; p = 0.53)] and target vessel revascularization in survivors [TVR (7.0 % vs. 5.0 % vs. 4.0 %; p = 0.47)] with normal weight when compared to overweight or obese patients. These results persisted after risk-adjustment for heterogeneous baseline characteristics of groups. An analysis of patients suffering from cardiogenic shock showed no impact of BMI on clinical endpoints. CONCLUSION: Our data from two network systems in Germany revealed no evidence of an "obesity paradox"in an all-comer STEMI population including patients with cardiogenic shock.

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.

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.

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.

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.

Relation between the frequency of CD34⁺ bone marrow derived circulating progenitor cells and the number of diseased coronary arteries in patients with myocardial ischemia and diabetes.

BACKGROUND: Bone marrow-derived circulating progenitor cells (BM-CPCs) in patients with coronary heart disease are impaired with respect to number and mobilization. However, it is unknown whether the mobilization of BM-CPCs depends on the number of diseased coronary arteries. Therefore, in our study, we analysed the correlation between the diseased coronary arteries and the frequency of CD34/45+ BM-CPCs in peripheral blood (PB) in patients with ischemic heart disease (IHD). METHODS: The frequency of CD34/45+ BM-CPCs was measured by flow cytometry 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 groups. RESULTS: The frequency of CD34/45+ BM-CPCs was significantly reduced in patients with IHD compared to the control group (CD34/45+; p < 0.001). The frequency of BM-CPCs was impaired in patients with IHD3 compared to IHD1 (CD34/45+; p < 0.001) and to IHD2 (CD34/45+; p = 0.001). But there was no significant difference in frequency of BM-CPCs between the patients with IHD2 and IHD1 (CD34/45+; p = 0.28). In a subgroup we observed a significant negative correlation between levels of hemoglobin AIc (HbAIc) and the frequency of BM-CPCs (CD34/45+; p < 0.001, r = -0.8). CONCLUSIONS: The frequency of CD34/45+ BM-CPCs in PB is impaired in patients with IHD. This impairment may augment with an increased number of diseased coronary arteries. Moreover, the frequency of CD34/45+ BM-CPCs in ischemic tissue is further impaired by diabetes in patients with IHD.

Improvement of cardiac function by intracoronary freshly isolated bone marrow cells transplantation in patients with acute myocardial infarction.

BACKGROUND: We analyzed in the present study the influence of intracoronary autologous freshly isolated bone marrow cells transplantation (BMCs-Tx) on cardiac function in patients with acute myocardial infarction (AMI). METHODS AND RESULTS: The 32 patients with AMI were enrolled in this prospective nonrandomized study to either freshly isolated BMC-Tx or to a control group without cell therapy. Global left ventricular ejection fraction (LVEF) and the size of infarct area were determined by left ventriculography. We observed in patients with autologous freshly isolated BMCs-Tx at 6 months follow up a significant reduction of infarct size as compared to control group. Moreover, we found a significant increase of LVEF as well as infarct wall movement velocity at 6 months follow up in cell therapy group as compared to control group. In the control group there was no significant difference of LVEF, infarct size and infarct wall movement velocity between baseline and 6 months after AMI. CONCLUSIONS: These results demonstrate for the first time that intracoronary transplantation of autologous freshly isolated BMCs by use of a point of care system is safe, and may lead to improvement of cardiac function in patients with AMI.

Impaired mobilization of CD133(+) bone marrow-derived circulating progenitor cells with an increased number of diseased coronary arteries in ischemic heart disease patients with diabetes.

BACKGROUND: The influence of the number of diseased coronary arteries on the mobilization of CD133/45(+) bone marrow-derived circulating progenitor cells (BM-CPCs) in peripheral blood (PB) in patients with ischemic heart disease (IHD) was analyzed. METHODS AND RESULTS: Mobilization of CD133/45(+) BM-CPCs by flow cytometry was measured in 120 patients with coronary 1 vessel (IHD1, n=40), coronary 2 vessel (IHD2, n=40), and coronary 3 vessel disease (IHD3, n=40), and in a control group (n=40). The mobilization of CD133/45(+) BM-CPCs was significantly reduced in patients with IHD compared to the control group (P<0.001). The mobilization of CD133/45(+) BM-CPCs was impaired in patients with IHD3 compared to IHD1 (P<0.001) and to IHD2 (P<0.001). But there was no significant difference in mobilization of CD133/45(+) BM-CPCs between the patients with IHD2 and IHD1 (P=0.35). Moreover, we found significantly reduced CD133/45(+) cell mobilization in patients with a high SYNTAX-Score (SS) compared to a low SS (P<0.001) and an intermediate SS (P<0.001). In subgroup analyzes, we observed a significantly negative correlation between levels of hemoglobin A(1c) and the mobilization of CD133/45(+) BM-CPCs (P=0.001, r=-0.6). CONCLUSIONS: The mobilization of CD133/45(+) BM-CPCs in PB is impaired in patients with IHD. This impairment might augment with increased number of diseased coronary arteries. Moreover, mobilization of CD133/45(+) BM-CPCs in ischemic tissue is further impaired by diabetes in patients with IHD.

Technique of interventional repair in adult aortic coarctation.

Surgical treatment of aortic coarctation has increased life expectancy and reduced mortality. Unfortunately, the average lifespan after repair remains only 35 to 50 years, and significant morbidity persists as a result of aneurysm formation, hypertension, accelerated coronary disease, and stroke. Follow-up studies have revealed restenosis rates of 30% and persistent hypertension at rest and during exercise, sometimes with compromised cardiac function. The less invasive nature of nonsurgical repair using transcatheter therapies has led to balloon angioplasty and, recently, stent implantation as an emerging concept for the treatment of aortic coarctation. This review focuses on advances in the management, current indication, and techniques of interventional repair in aortic coarctation.

The paclitaxel-eluting coroflex stent study II (PECOPS II) acute and 6-month clinical and angiographic follow-up, 1-year clinical follow-up.

BACKGROUND AND OBJECTIVES: Paclitaxel-coated stents have proven their efficacy for reducing restenosis in de novo coronary artery lesions and in-stent restenoses with superiority compared to bare metal stents. This study was performed to evaluate the procedural and 1 year results of the Paclitaxel-eluting Coroflex Please stent in coronary artery lesions. METHODS: One-hundred and twenty-nine patients (66.2 +/- 8.2 years, 31.0% diabetics, 20.2% unstable angina, 41.8% multivessel disease) were enrolled per protocol for elective single stent deployment into native de novo or post-PTCA restenotic coronary lesions.The mean reference diameter was 2.84 +/- 0.43 mm, the lesion length 12.51 +/- 4.6 mm, and the minimal lumen diameter 0.75 +/- 0.29 mm. Follow-up was performed clinically in 129/129 (100%) after 6 and 12 months and angiographically in 120/129 (93%) patients after 6 months. RESULTS: The success rates of the procedure and deployment were 100% and 95.3%, respectively. The in-stent late loss and the late-loss index were 0.27 +/- 0.59 mm and 0.17 +/- 0.40 resulting in binary in-stent restenoses in 16/120 (13.3%) subjects and in-segment restenoses in 20/120 (16.7%) subjects. Major adverse cardiac events occurred in 23/129 (17.8%) during the first 6 months of follow-up with 3/129 (2.3%) myocardial infarctions, 1/129 (0.8%) secondary to stent thrombosis. From 6 to 12 months, 2/129 (1.6%) nonlesion related PCI were performed. CONCLUSION: The data of the Paclitaxel-eluting Coroflex Please stent evaluated in PECOPS II are within the range of the other currently available Paclitaxel-eluting stent.

The paclitaxel-eluting Coroflex Please stent study (PECOPS I): the 3-year clinical follow-up.

BACKGROUND: The evaluation of drug-eluting devices in humans should include longterm follow-up owing to risk of late target vessel thrombosis with the possible fatal sequel. METHODS AND RESULTS: Therefore, the three-year clinical outcome of the paclitaxel-eluting Corofiex Please stent in patients with de-novo coronary lesions was evaluated in the single-arm PECOPS I pilot study. The clinical data of 123/125 (98.4%) of all patients included were available 3.05 +/- 0.12 years following stent deployment. In the intention-to-treat analysis the incidence of cardiac death was 9/123 (7.3%), of myocardial infarction 4/123 (3.3%), and of in-segment target lesion revascularization 14/123 (11.4%). Target lesion revascularizations tended (p = 0.30) to occur less frequently (9/96 (16.6%)) in those patients in whom the stent length was longer than the lesion (4.80 +/- 2.71 mm) compared to 5/27 (18.5%) in those patients in whom the stent was shorter than the lesion (-3.0 +/- 2.43 mm). Stent thromboses occurred in 2/123 (1.6%) patients during the first 6 months, one of which two days after premature discontinuation of clopidogrel. The total 3-year MACE rate was 22/123 (17.9%). CONCLUSION: The present study describes the paclitaxel-eluting Corotlex Please stent as a safe device with good long term performance when deployed in native coronary arteries. The occurrence of late major adverse events and late thromboses in particular seem to be very low.

Renal Insufficiency Following Radiocontrast Exposure Trial (REINFORCE): a randomized comparison of sodium bicarbonate versus sodium chloride hydration for the prevention of contrast-induced nephropathy.

INTRODUCTION: For the prevention of contrast-induced nephropathy (CIN) after coronary angiography, hydration by 0.9% sodium chloride solution and N-acetylcysteine is currently recommended. However, it is unclear whether volume supplementation with sodium bicarbonate is better than with sodium chloride when used in conjunction with nonionic, low-osmolar iopamidol. The aim of this study was to analyze and compare the effects of sodium bicarbonate and sodium chloride on renal function in 145 patients exposed to nonionic iso-osmolar contrast medium iodixanol in a randomized study. PATIENTS AND METHODS: Renal Insufficiency Following Radiocontrast Exposure is a prospective, randomized, single-center, double-blinded trial of 145 patients (age 72.6+/-6.7 years) with elevated baseline serum creatinine levels (mean 132.6+/-29.3 micromol/l). Eligible patients were randomized to either a 154 mEq/l infusion of sodium bicarbonate (n=71, group I) or sodium chloride 0.9% solution (n=74, group II). The primary endpoint was serum creatinine elevation beyond 25% or 44 micromol/l on the first or second day following exposure to the contrast medium. Serum creatinine, serum cystatin C, plasma viscosity, urinary enzymes alanine aminopeptidase and N-acetyl-beta-D-glucosaminidase, and alpha1-microglobulin were measured at baseline and on days 1 and 2 after contrast medium administration. RESULTS: An overall proportion of five CIN (3.4%) was observed with equal distribution among the groups (4.2% in sodium bicarbonate group vs. 2.7% in sodium chloride group; P=0.614). Parameters of renal function demonstrated no differences between the two hydration regimens on day 1 after angiography; even on day 2 most parameters were similar in groups I and II. CONCLUSION: Renal Insufficiency Following Radiocontrast Exposure demonstrates a homogeneously low rate of CIN after exposure to nonionic, iso-osmolar iodixanol regardless of the use of either bicarbonate sodium or sodium chloride solution for volume supplementation. Low-toxicity contrast media and any hydration may offset potential antioxidant effects of sodium bicarbonate.

Current role of endovascular therapy in Marfan patients with previous aortic surgery.

The Marfan syndrome is a heritable disorder of the connective tissue which affects the cardiovascular, ocular, and skeletal system. The cardiovascular manifestation with aortic root dilatation, aortic valve regurgitation, and aortic dissection has a prevalence of 60% to 90% and determines the premature death of these patients. Thirty-four percent of the patients with Marfan syndrome will have serious cardiovascular complications requiring surgery in the first 10 years after diagnosis. Before aortic surgery became available, the majority of the patients died by the age of 32 years. Introduction in the aortic surgery techniques caused an increase of the 10 year survival rate up to 97%. The purpose of this article is to give an overview about the feasibility and outcome of stent-graft placement in the descending thoracic aorta in Marfan patients with previous aortic surgery.

Comparison of a novel biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: results of the randomized BIOFLOW-II trial.

BACKGROUND: Biodegradable polymers for release of antiproliferative drugs from drug-eluting stents aim to improve vascular healing. We assessed noninferiority of a novel ultrathin strut drug-eluting stent releasing sirolimus from a biodegradable polymer (Orsiro, O-SES) compared with the durable polymer Xience Prime everolimus-eluting stent (X-EES) in terms of the primary end point in-stent late lumen loss at 9 months. METHODS AND RESULTS: A total of 452 patients were randomly assigned 2:1 to treatment with O-SES (298 patients, 332 lesions) or X-EES (154 patients, 173 lesions) in a multicenter, noninferiority trial. The primary end point was in-stent late loss at 9 months. O-SES was noninferior to X-EES for the primary end point (0.10±0.32 versus 0.11±0.29 mm; difference=0.00063 mm; 95% confidence interval, -0.06 to 0.07; Pnoninferiority<0.0001). Clinical outcome showed similar rates of target-lesion failure at 1 year (O-SES 6.5% versus X-EES 8.0%; hazard ratio=0.82; 95% confidence interval, 0.40-1.68; log-rank test: P=0.58) without cases of stent thrombosis. A subgroup of patients (n=55) underwent serial optical coherence tomography at 9 months, which demonstrated similar neointimal thickness among lesions allocated to O-SES and X-EES (0.10±0.04 mm versus 0.11±0.04 mm; -0.01 [-0.04, -0.01]; P=0.37). Another subgroup of patients (n=56) underwent serial intravascular ultrasound at baseline and 9 months indicating a potential difference in neointimal area at follow-up (O-SES, 0.16±0.33 mm(2) versus X-EES, 0.43±0.56 mm(2); P=0.04). CONCLUSIONS: Compared with durable polymer X-EES, novel biodegradable polymer-based O-SES was found noninferior for the primary end point in-stent late lumen loss at 9 months. Clinical event rates were comparable without cases of stent thrombosis throughout 1 year of follow-up. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01356888.

Short term cost effectiveness of a regional myocardial infarction network.

AIMS: Myocardial infarction networks have been shown to improve guideline adherent therapy and outcomes in patients presenting with acute ST-elevation myocardial infarction (STEMI). Our objective was to assess the short term cost effectiveness of a network structure. METHODS AND RESULTS: Outcome data and reimbursement data for the index hospital stay were gathered in consecutive patients with acute STEMI (n = 536) admitted to any of the hospitals in a 350.000 inhabitant rural network area during the years 2002 (n = 185), 2005 (n = 163) and 2008 (n = 188). Network structure was established between 2002 and 2005 aiming for identical treatment of all acute STEMI patients during 24 h/7d a week with primary angioplasty. Patient baseline characteristics in the different years were quite comparable. From 2002 to 2005 regional hospital mortality in STEMI patients decreased from 16% to 9%. Lower mortality under network conditions was confirmed in 2008. Reimbursement data of different years were standardized to exclude effects not induced by the network. The mean initial costs per saved live during the index stay were €7727 with a 95%-confidence interval of €-3.500 to €36.700 (referenced to the German reimbursement in 2005). CONCLUSION: The short term cost effectiveness of a myocardial infarction network organisation is within well accepted boundaries under conditions of the German reimbursement system.

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.

Twelve-month results of a paclitaxel releasing balloon in patients presenting with in-stent restenosis First-in-Man (PEPPER) trial.

BACKGROUND: Coronary in-stent restenosis (ISR) continues to be a therapeutic challenge especially after drug eluting stent (DES) implantation. We studied patients with ISR to investigate safety and efficacy of a novel drug coated balloon (DCB) incorporating paclitaxel into a microcrystalline structure by applying the inert excipient butyryltri-n-hexyl citrate (BTHC) in a prospective First-in-Man trial. METHODS AND MATERIALS: Eighty-one patients were enrolled at 9 European sites, thereof 43 (53.1%) presenting with bare metal stent (BMS)-ISR and 38 (46.9%) with DES-ISR. The primary study endpoint was in-stent late lumen loss (LLL) independently assessed by a quantitative coronary angiography laboratory at 6 months. A secondary endpoint was major adverse cardiac events (MACE), a composite of cardiac death, non-fatal myocardial infarction, clinically driven target vessel revascularization after 6 and 12 months. RESULTS: At 6 months, overall LLL was 0.07±0.31 mm showing differences in BMS-ISR and DES-ISR treatment (-0.05±0.28 mm vs. 0.19±0.29 mm, respectively, P=.001). Overall MACE rates at 6 and 12 months were 6.5% and 11.8%. At the 12-month follow-up, one myocardial infarction, and no cardiac death nor stent thrombosis had occurred. CONCLUSION: Application of a novel paclitaxel coated balloon using BTHC as an excipient in patients with ISR is safe and results in very low LLL, revascularization- and MACE-rates at follow-up. (ClinicalTrials.gov: NCT00961181).

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.