Functional impairment assessed by the Barthel Index influenced outcomes after transcatheter aortic valve implantation.

Objective. We investigated the influence of functional impairment assessed by the Barthel index (BI) on the three-month outcomes after transfemoral-transcatheter aortic valve intervention (TF-TAVI) under general anesthesia. Design. We included retrospectively analyzed 336 patients undergoing TAVI between January 2017 and January 2018 in central hospital, Bad Berka, Germany. All patients were followed up at three-month in our center's outpatient clinic. We stratified the patients according to the BI. Results. At baseline, 76 patients had a BI <80. Patients with a BI <80 were characterized by advanced age (80.6 ± 5.6 vs. 83 ± 4.1 years. p = .027), diabetes mellitus on insulin and higher surgical risk scores. A prior cerebral ischemic event was recorded more in patients with a BI ≥80. Regarding intermediate outcomes, three-month mortality was significantly higher in patients with a BI <80. Patients with a BI <80 developed significantly more postoperative cardiac decompensation, delirium and strokes. Patients with BI <80 had lower hemoglobin level preoperative and needed more blood transfusion postoperative. Other valve academic research consortiums (VARCs) complications were equally distributed in both groups. A BI <80 was associated with prolonged postoperative hospital stay and was an independent predictor of FT protocol failure (OR 4; CI 95% 1.3-11. p .02). Conclusions. A BI <80 is associated with increased mortality and risk of neurological events and cardiac decompensations after TF TAVI. A BI <80 is an independent predictor of failure in fast track TAVI.

A randomized multicentre trial to compare revascularization with optimal medical therapy for the treatment of chronic total coronary occlusions.

Aims: The clinical value of percutaneous coronary intervention (PCI) for chronic coronary total occlusions (CTOs) is not established by randomized trials. This study should compare the benefit of PCI vs. optimal medical therapy (OMT) on the health status in patients with at least one CTO. Method and results: Three hundred and ninety-six patients were enrolled in a prospective randomized, multicentre, open-label, and controlled clinical trial to compare the treatment by PCI with OMT with a 2:1 randomization ratio. The primary endpoint was the change in health status assessed by the Seattle angina questionnaire (SAQ) between baseline and 12 months follow-up. Fifty-two percent of patients have multi-vessel disease in whom all significant non-occlusive lesions were treated before randomization. An intention-to-treat analysis was performed including 13.4% failed procedures in the PCI group and 7.3% cross-overs in the OMT group. At 12 months, a greater improvement of SAQ subscales was observed with PCI as compared with OMT for angina frequency [5.23, 95% confidence interval (CI) 1.75; 8.71; P = 0.003], and quality of life (6.62, 95% CI 1.78-11.46; P = 0.007), reaching the prespecified significance level of 0.01 for the primary endpoint. Physical limitation (P = 0.02) was also improved in the PCI group. Complete freedom from angina was more frequent with PCI 71.6% than OMT 57.8% (P = 0.008). There was no periprocedural death or myocardial infarction. At 12 months, major adverse cardiac events were comparable between the two groups. Conclusion: Percutaneous coronary intervention leads to a significant improvement of the health status in patients with stable angina and a CTO as compared with OMT alone. Trial registration: NCT01760083.

Transapical tricuspid valve-in-ring implantation: An alternative approach to a challenging clinical scenario.

We report on a transapical tricuspid valve-in-ring implantation performed via right ventricular apex using the Sapien-XT-prosthesis. A 57-year-old woman with recurrent episodes of right heart failure and three previous sternotomies, including tricuspid valve repair with a 32 mm Carpentier-Edwards-Classic annuloplasty ring was admitted due to recurrent severe tricuspid regurgitation. Given the excessive surgical risk, a 29 mm Sapien-XT-prosthesis was selected for valve-in-ring implantation. Transapical valve-in-ring implantation procedure was uneventful. Predischarge echocardiography showed only trace paravalvular tricuspid regurgitation in the septal region. Transapical approach via right ventricular apex is a viable alternative for tricuspid valve-in-ring implantation in selected high-risk patients. © 2016 Wiley Periodicals, Inc.

Patients' preferences for coronary bypass grafting or staged percutaneous coronary intervention in multi-vessel coronary artery disease.

BACKGROUND: The decision for coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) in patients with multi-vessel coronary artery disease (mCAD) is currently made by a heart-team approach. Patients' preference is less well investigated. METHODS: All consecutive patients with prior CABG and at least 2 PCI procedures were interviewed whether they would elect bypass surgery or staged PCI in case of a hypothetical scenario in which they had mCAD and CABG or PCI will equally improve symptoms and survival. RESULTS: A total 213 patients were surveyed. About 21 (10%) patients had multiple CABG, and mean number of PCI per patient was 4.0 ± 2.7. Complications during CABG were reported in 19.7% and in 14% after PCI, respectively. About 15% experienced complications after both CABG and PCI, and 51% had no complications at all. Mean symptom-free period was 5.2 (following CABG) vs 1.8 years (following PCI); P<.001. Duration of recovery was significant shorter after PCI (mean 9.2 ± 1.2 vs 136.4 ± 57.9 days; P<.01). Based on their personal experience with both procedures, 15% of the participants elected CABG in the hypothetical scenario and 67% choose staged PCI, 18% were equally happy with either. More participants preferred PCI when age was ≥70, complications following CABG occurred, and when undergoing CABG first. Gender, number of CABG or PCI procedures per patient, and complications following PCI did not affect participants' preference. CONCLUSIONS: In our hypothetical scenario, the majority of participants preferred staged PCI over CABG. Preferences were related to age, complications following CABG, and whether CABG was performed first.

Presentation and management of symptomatic central bone cement embolization.

BACKGROUND CONTEXT: With more cement augmentation procedures done, the occurrence of serious complications is also expected to rise. Symptomatic central cement embolization is a rare but very serious complication. Moreover, the pathophysiology and treatment of intrathoracic cement embolism remain controversial. PURPOSE: In this case series, we are trying to identify various presentations and suggest our emergent management scheme for symptomatic central cement embolization. PATIENT SAMPLE: Retrospective case series of nine patients with symptomatic central cement embolism identified after vertebroplasty with 24 months of follow-up. Level IV. OUTCOME MEASURES: The degree of dyspnea measured by the New York Heart Association (NYHA) score and/or death related to cement embolism induced cardio/respiratory failure at the final follow-up at 24 months. METHODS: The nine patients, eight females, and one male had a mean age of 70.25 years (range 65-78 years) and were operated between January 2004 and December 2014. They had percutaneous vertebroplasty for osteoporotic non-traumatic and malignant vertebral collapse of dorsal and lumbar vertebrae. Post-vertebroplasty dyspnea and stitching chest pain were striking in the nine patients. After exclusion of cardiac ischemia and medical pulmonary causes for dyspnea, we identified radiopaque lesions on the chest X-ray. Further echocardiography and high-resolution chest CT were performed for optimal localization. Emergent heart surgery was performed in two patients: interventional therapy was conducted in one patient, while the remaining six patients were conservatively treated by anticoagulation. The management decision was taken in the setting of an interdisciplinary meeting depending on localization, fragmentation, and clinical status. RESULTS: All patients of this series showed gradual improvement and an uneventful hospital stay. During our 24-month follow-up phase, eight patients showed no subsequent cardiological and/or respiratory symptoms (NYHA I). However, one mortality due to advanced malignancy occurred. Preoperative anemia was the only common intersecting preoperative parameter among these nine patients. CONCLUSIONS: After cement augmentation, close clinical monitoring is mandatory. A chest CT is pivotal in determining the interdisciplinary management approach in view of the availability of necessary expertise, facilities and the location of the cement emboli whether accessible by cardiac or vascular surgical means. The clinical presentation and its timing may vary and the patient may be seen subsequently by other health care providers obligating a wide-spread awareness for this serious entity among health care providers for this age group as spine surgeons, family and emergency room doctors, and institutional or home-care nurses. Most symptomatic central cement emboli may be treated conservatively.

Interaction between shock coils increased the incidence of inappropriate therapies and lead failure in implantable cardioverter defibrillator.

AIMS: Shock coil interaction in patients with multiple implantable cardioverter defibrillator (ICD) leads is occasionally observed. We aimed to evaluate the incidence of shock coil interaction and its clinical relevance. METHODS AND RESULTS: All ICD patients (646 patients) who came to follow up control in our ICD ambulance between January 1, 2011, and December 31, 2011 in the department of cardiology in Bad Berka hospital were retrospectively evaluated in this study. All baseline demographic, clinical, and procedural characteristics and postoperative chest x ray in postero-anterior and lateral view as well as clinical and ICD follow up data were evaluated. Among 646 patients 42 had multiple ICD leads (6.5%) of whom 36 patients (5.5% of total cohort patients and 85.7% of patients with multiple ICD leads) had shock coil interaction and presented the study group (Group I). The control group (Group II) consisted of 610 patients without coil-coil interaction including patients with single shock lead (604 patients) or patients with multiple leads but without interaction between shock coils (6 patients). Inappropriate anti-tachycardia therapies and RV lead revisions were more frequent in patients with interaction between shock coils (Group I vs Group II: 27.7% and 5.7%; p = 0.049 and 30.6% vs 6.4; p = 0.0001, respectively). CONCLUSIONS: Interaction between shock coils may be one of possible causes of lead failure and resulted in inappropriate therapies and subsequent lead revision.

Effect of intraoperative local application of 3% hydrogen peroxide on pocket infections following cardiac implantable electronic device implantation: An observational study.

AIMS: The aim of this study was to analyze whether local application of 3% hydrogen peroxide (H2O2) additionally to standard antibiotic prophylaxis following implantation of cardiac implantable electronic devices (CIED) reduces the incidence of pocket infections (PI). METHODS: In this observational case-control study every patient from the group additionally treated with H2O2 was matched with two patients out of the control group for age, male-gender, body-mass-index and operation time. The incidence of PI within 365 days after device implantation was compared. RESULTS: During the 5-year study period, 429 consecutive patients were additionally treated with H2O2 and matched with 858 patients undergoing standard treatment (mean age 69 ±â€¯12 years, 876 males (67.4%), body-mass-index 28 ±â€¯4.0 kg/m2 and operation time 45 ±â€¯23 min). Except for a more frequent use of dual-platelet-inhibition in the H2O2-group, clinical characteristics were otherwise similar. A total of 23 (1.78%) PIs occurred, most of them (14/23; 61%) during the first 45 days after implantation procedure. The use of H2O2 was associated with a significant reduction (3/429 = 0.69% versus 20/858 = 2.33%; p = 0.04), although patients of the H2O2 treated group received more complex procedures increasing the risk of PI. CONCLUSION: Intraoperative local application of 3% H2O2 seems to be associated with a significant reduced incidence of PI following implantation of CIED. Because of its non-randomized character this trial should be considered as a hypothesis generating study.

Comparative Case-Control analysis of a dedicated self-expanding Biolimus A9-eluting Bifurcation stent versus provisional or mandatory side branch intervention strategies in the treatment of coronary bifurcation lesions.

BACKGROUND: In a number of coronary bifurcation lesions, both the main vessel and the side branch (SB) need stent coverage. OBJECTIVES: To analyze the procedural performance and the impact on radiation times (RT) and contrast medium consumption (CMC) of the Axxess™ stent system (Biosensors, Switzerland) treating de novo bifurcation lesions (DBL). METHODS: One hundred and ten consecutive prospectively enrolled cases (Axxess Group) and 110 age, sex, and lesion location matched controls undergoing mandatory (Group A, n = 56) or provisional (Group B, n = 54) SB intervention were analyzed. RESULTS: Although more pre-dilatation was performed in the Axxess Group (92.7% vs. 46.4% [Group A] vs. 24.1% [Group B]), and more stents were used (2.4 vs. 1.2 vs. 1.05), RT and CMC were significantly lower in the Axxess Group [7.9 min/129 ml vs. 14.2 min/209 ml vs. 7.8 min/152 ml; P < 0.001]. Final Thrombolysis In Myocardial Infarction three flow in both branches was significantly more frequent in the Axxess Group (98.2% vs. 94.6% vs. 88.9%; P = 0.02), and post-interventional troponin T elevations were the lowest in the Axxess Group. Eighty one percent of the Axxess-stents could be implanted without technical difficulties. Difficult implantations procedures were mainly related to coronary anatomy. There was no safety concerns (cardiac death, stent-thrombosis) compared to controls. Cumulative 6-months MACE rates were 11% versus 23% versus 25%. TLR rates at 6-months were 5%, 18%, and 15%, respectively. CONCLUSIONS: Axxess bifurcation stent system procedures were associated with significantly less RT and CMC compared to conventional DBL therapy strategies. Difficult coronary anatomy may hinder successful implantation and a learning curve has to be considered. © 2016 Wiley Periodicals, Inc.

Pathophysiological Factors Associated with Left Ventricular Perforation in Transcatheter Aortic Valve Implantation by Transfemoral Approach.

BACKGROUND AND AIM OF THE STUDY: Left ventricular (LV) perforation is one of the rare and most serious complications of transcatheter aortic valve implantation (TAVI). The study aim was to determine the pathophysiological factors associated with this serious complication. METHODS: A retrospective study was conducted of pathophysiological factors shown in echocardiograms and computed tomography angiograms performed preoperatively in patients who developed LV perforation during transfemoral TAVI (study group) with regards to anatomic and functional variables. Results were then compared with data acquired from a randomly selected sample of patients without perforation (control group). Among 963 TAVI cases, LV perforation occurred in 11 patients (three males, eight females; mean age 79 years). These patients showed complications of LV perforation that required emergency sternotomy and repair of injury to the left ventricle. Ten patients were rescued by the procedure, but one patient died during surgery. RESULTS: Focus on preoperative factors and intraoperative steps was established in favor to identify possible predictors of LV perforation. A LV cavity size <4.2 cm and a hypercontractile ventricle were identified in 10 patients (90%). Only one patient had a dilated cardiomyopathic left ventricle, with a cavity size of 6.1 cm and an ejection fraction of 10%. The present study results revealed other specific patient-related factors, namely a narrow aorto-mitral angle and a thin ventricular muscular wall despite long-standing aortic stenosis. All 11 patients had an average mid-LV muscular wall thickness of 5 mm. An inverse proportional relationship between the aorto-mitral angle and the incidence of perforation was noted, where in all 11 patients the wire had directed itself towards the anterior free wall of the left ventricle, where it induced injury. CONCLUSIONS: A small LV cavity, a hypercontractile state, a thin muscular wall, and a narrow aorto-mitral angle may be considered potential predictors of the occurrence of LV perforation during TAVI.

Incidence, predictors, and outcome of inadvertent malposition of transvenous pacing or defibrillation lead in the left heart.

AIMS: Inadvertent lead malposition (ILM) in the left heart is a potential cause of thromboembolism and, therefore, a complication of heart rhythm device implantation [HRDI: pacemaker, implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT)]. The aim of the study was to report the incidence and clinical outcome of ILM. METHODS AND RESULTS: Postoperative lateral and posterior-anterior chest X-rays of all consecutive patients undergoing HRDI from 2007 through 2012 were retrospectively analysed. During the study period, 2579 patients underwent HRDI at our institution. ILM was present in six patients (0.34%, 50% male, mean age 71.5 ± 9.4 years). In one and four patients, malposition was in the left atrium and ventricle, respectively. In one case, the RV-lead was placed in a coronary sinus branch. In four patients, ILM was detected intra-operatively or in the early postoperative period. In the remaining two patients, malposition was not recognized and they suffered cerebral embolism 4 months and 1 year after implantation. ILM was corrected during the same hospital stay (four cases), or during follow-up by percutaneous extraction (two cases). Patients with ILM had significantly more scoliosis (16.7 vs. 0.17%; P = 0.01), congenital heart disease (CHD: 33.3 vs. 0.4%; P = 0.003), or prior surgery for CHD (16.7 vs. 0.5%; P = 0.03). The likelihood of ILM was also increased when HRDI was performed by an inexperienced operator (<100 HRDI; P < 0.01). CONCLUSION: The incidence of ILM was 0.34% in our series. Scoliosis, CHD, prior correction of CHD, and limited operator experience were identified as risk factors.

A hybrid approach for quantifying aortic valve stenosis using impedance cardiography and echocardiography.

BACKGROUND: Impedance cardiography (IC) is a noninvasive modality that utilizes changes in impedance across the thorax to assess hemodynamic parameters, including stroke volume (SV). This study compared aortic valve area (AVA) as assessed by a hybrid approach of transthoracic echocardiography (TTE) and impedance cardiography (IC) to AVA determined at cardiac catheterization using the Gorlin equation. METHODS: A total of 30 patients with moderate to severe aortic stenosis underwent AVA measurement using two different approaches: using the continuity equation (CE) in a hybrid method combining IC and TTE (AVA = stroke by volume impedance cardiography/trans-aortic-VTI) and using the Gorlin equation. Patient age ranged from 37 to 82 years (mean 48); there were 21 men and 9 women. Twenty-five patients were in sinus rhythm, and five had atrial fibrillation. RESULTS: There was no statistically significant difference for the mean AVA between the two methods (0.7 ± 0.24 cm(2) using the Gorlin equation versus 0.7 ± 0.23 cm(2) using the hybrid approach, p = 0.17; r = 0.76, p < 0.001). The mean difference was 0.004 cm(2), and the limits of agreement were -0.33 to 0.37. CONCLUSION: The hybrid method using impedance cardiography and TTE is a reasonable, clinically applicable approach to evaluate AVA and has significant correlation to invasive measurement using the Gorlin equation.

Anticoagulation After Biological Aortic Valve Replacement: Is There An Optimal Regimen?

BACKGROUND: The anticoagulation of biological heart valves remains a 'hot spot' of discussion in various domains due to the risk of developing valve thrombosis and arterial thromboembolism. The situation has always been controversial, especially during the early postoperative phase. The American College of Cardiology/ American Heart Association and European Society of Cardiology guidelines recommend the use of warfarin for the first three months after biological aortic valve replacement (BAVR), although the American College of Chest Physicians guidelines suggest that these recommendations are experience-based and that the risk/benefit is unclear. The aim of the present study was to compare the efficacy of aspirin and warfarin in patients after BAVR. METHODS: A total of 863 patients who underwent BAVR between 2008 and 2015 was allocated to two groups. Each group was managed with a specific anticoagulation regimen, with 430 patients receiving warfarin during the first three postoperative months, and 433 receiving aspirin. The major study end points were bleeding, cerebral ischemic events, and survival. RESULTS: In total, 10 and 15 postoperative cerebral ischemic events occurred between 24 h and three months after surgery in patients treated with aspirin and warfarin, respectively. After three months the incidence of cerebral ischemic events did not differ greatly between the two groups. The rate of major bleeding events and rates of stroke-free survival and overall survival were not statistically significant between the warfarin and aspirin groups. CONCLUSIONS: Plasma anticoagulation with warfarin during the early postoperative phase was shown statistically to be inferior to platelet aggregation inhibition by aspirin with regards to postoperative bleeding risk, cerebral ischemic events, and survival.

Incidence of ineffective safety margin testing (<10 J) and efficacy of routine subcutaneous array insertion during implantable cardioverter defibrillator implantation.

The purpose of this study was to assess (1) the incidence of safety margin testing <10 J (SMT) and (2) the efficacy/safety of routinely adding a subcutaneous array (SQA) (Medtronic 6996SQ) for these patients. Patients with SMT smaller than a 10-J safety margin from maximum output were considered to have very high readings and underwent SQA insertion. These patients were compared with the rest of the patients who had acceptable SMT (≥10 J). A total of 616 patients underwent ICD implantation during the analysis period. Of those, 16 (2.6%) had SMT <10 J. By univariate analysis, younger age, and non-ischemic cardiomyopathy, were all significant predictors of SMT <10 J (p < 0.05). In all 16 cases, other methods to improve SMT prior to array insertion were attempted but failed for all patients: reversing shock polarity (n = 15), removing the superior vena cava coil (n = 14), reprogramming shock waveform (n = 9), and repositioning right ventricular lead (n = 9). Addition of the SQA successfully increased SMT to within safety margin for all patients (32 ± 2 versus 21 ± 3 J; p < 0.001). Follow-up (mean 48.1 ± 21 months) was available for all patients with SQA, only 2 cases with inappropriate shocks due to atrial fibrillation had to be noted. None of the patients experienced complications due to SQA implantation. SMT <10 J occur in about 2.6% of patients undergoing ICD implantation. SQA insertion corrects this problem without procedural/mid-term complications.

Acute coronary syndrome without critical epicardial coronary disease: prevalence, characteristics, and outcome.

BACKGROUND: Absence of significant epicardial coronary artery stenosis in patients with acute onset of chest pain and elevation of myocardial necrosis markers is occasionally observed. The aim of this study was to retrospectively analyze the clinical characteristics and the outcome of such patients. METHODS: All patients with myocardial infarction (MI) but without significant coronary artery stenosis (≥50%) on angiography from May 2002 to April 2011 were compared with patients undergoing percutaneous coronary intervention due to non-ST-elevation MI (NSTEMI). RESULTS: Of 4311 consecutive patients with MI, 272 patients (6.3%) did not show significant coronary artery stenosis (group I) and were compared with 253 NSTEMI patients (group II). Younger age (61.9±14.0 vs 65.4±12.0 years; P=.003), female sex (49.3% vs 28.9%; P<.001), less severe anginal symptoms (Canadian Cardiovascular Society class III/IV 41.9% vs 49.8%; P=.05), lower level of myocardial necrosis marker (1.9±6.7 vs 27.4±68.7 ng/mL [troponin], 3.3±4 vs 14.2±20 mmol/L [creatine kinase]; P<.001 for both), and higher left ventricular ejection fraction (58.7%±12.6% vs 48.1%±12.4%; P<.01) were associated with group I patients. At a mean follow-up of 22.3±22.9 months, all-cause and cardiac mortality was lower in group I patients (4.9% vs 14.3%; and 2.9% vs 10.1%; P<.01, for both). Event-free survival was more frequent in group I patients (58.4% vs 28.8%; P<.0001) and inversely related to the troponin level. CONCLUSIONS: Absence of significant coronary stenosis accounts for a minority of patients presenting with MI and is associated with a better outcome compared to patients with NSTEMI, and the prognosis is inversely related to the troponin level.

Intra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock (IABP-SHOCK II): final 12 month results of a randomised, open-label trial.

BACKGROUND: In current international guidelines the recommendation for intra-aortic balloon pump (IABP) use has been downgraded in cardiogenic shock complicating acute myocardial infarction on the basis of registry data. In the largest randomised trial (IABP-SHOCK II), IABP support did not reduce 30 day mortality compared with control. However, previous trials in cardiogenic shock showed a mortality benefit only at extended follow-up. The present analysis therefore reports 6 and 12 month results. METHODS: The IABP-SHOCK II trial was a randomised, open-label, multicentre trial. Patients with cardiogenic shock complicating acute myocardial infarction who were undergoing early revascularisation and optimum medical therapy were randomly assigned (1:1) to IABP versus control via a central web-based system. The primary efficacy endpoint was 30 day all-cause mortality, but 6 and 12 month follow-up was done in addition to quality-of-life assessment for all survivors with the Euroqol-5D questionnaire. A masked central committee adjudicated clinical outcomes. Patients and investigators were not masked to treatment allocation. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, NCT00491036. FINDINGS: Between June 16, 2009, and March 3, 2012, 600 patients were assigned to IABP (n=301) or control (n=299). Of 595 patients completing 12 month follow-up, 155 (52%) of 299 patients in the IABP group and 152 (51%) of 296 patients in the control group had died (relative risk [RR] 1·01, 95% CI 0·86-1·18, p=0·91). There were no significant differences in reinfarction (RR 2·60, 95% CI 0·95-7·10, p=0·05), recurrent revascularisation (0·91, 0·58-1·41, p=0·77), or stroke (1·50, 0·25-8·84, p=1·00). For survivors, quality-of-life measures including mobility, self-care, usual activities, pain or discomfort, and anxiety or depression did not differ significantly between study groups. INTERPRETATION: In patients undergoing early revascularisation for myocardial infarction complicated by cardiogenic shock, IABP did not reduce 12 month all-cause mortality. FUNDING: German Research Foundation; German Heart Research Foundation; German Cardiac Society; Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte; University of Leipzig--Heart Centre; Maquet Cardiopulmonary; Teleflex Medical.

Incidence of adverse cardiac events 5 years after polymer-free sirolimus eluting stent implantation: Results from the prospective Bad Berka Yukon Choice™ registry.

OBJECTIVES: Drug-eluting stents (DES) constitute a major achievement in preventing re-stenosis, concerns remain regarding the increased inflammatory responses associated with the polymers used. This analysis focuses on outcomes in patients receiving the polymer-free sirolimus-eluting stent system YUKON-Choice (Yukon-DES, Translumina, Germany). METHODS: From 01/2006-09/2008 all patients receiving Yukon-DES (≥2.5 mm diameter) were prospectively enrolled in our registry. The primary endpoint was long-term major adverse cardiac events (MACE). RESULTS: 701 patients were included in our registry. Mean age was 65.7 ± 10 years (73% male gender, 35.5% diabetes, and 32.2% acute coronary syndrome). 76% of the lesions were of Type B2/C. Lesion length was 24.6 ± 5.2 mm and mean stent diameter was 2.8 ± 0.4 mm. A total of 511 pts (72%) underwent 6-months angiographic follow-up, target vessel revascularization was noted in 23.5%. At 5 years clinical outcomes were: cardiac death 5.8%; myocardial infarction 3.4%; and TVR 24.6%. The incidence of MACE differed significantly between "on-label" and "off-label" indications (14.8% vs. 40.8% MACE; P < 0.001). Incidence of definitive/probable stent thrombosis (ST) was 1.14% (8/701); very late (>1 year) ST occurred in 0.29%. CONCLUSION: Our data suggests that the implantation of the sirolimus-coated polymer-free YUKON-DES is safe and feasible with a very low incidence of ST in this real world patient cohort with high percentage of diabetes and small vessels.

Five-year clinical follow-up of a randomized comparison of a polymer-free sirolimus-eluting stent versus a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus (LIPSIA Yukon trial).

OBJECTIVES: The long-term performance of polymer-free stent systems in patients with diabetes mellitus has not been investigated extensively. This study reports long-term results of the LIPSIA Yukon trial which compared the polymer-free sirolimus-eluting Yukon Choice stent with the polymer-based paclitaxel-eluting Taxus Liberté stent in this subpopulation. At 9 months, the Yukon Choice stent failed to show non-inferiority in terms of the primary end point late lumen loss, while no significant difference in clinical outcome was detected. METHODS AND RESULTS: The LIPSIA Yukon trial randomized 240 patients with diabetes mellitus to a polymer-free sirolimus eluting stent (Yukon Choice, Translumina) versus a polymer-based paclitaxel-eluting stent (Taxus Liberté, Boston Scientific). Clinical follow-up was conducted with a standardized telephone follow-up and all events were centrally adjudicated. Follow-up was available for 98.3% of patients after a median of 5.0 years. The incidence of all-cause death (16.9% versus 14.0%, P = 0.67), respectively definite or presumed cardiovascular death (7.6% versus 8.8%, P = 0.94) were similar in the Yukon Choice and the Taxus Liberté group. There were no significant differences in the rates of myocardial infarction (9.3% versus 7.9%, P = 0.88), definite stent thrombosis (0.8% versus 0.9%, P = 1.0), target lesion revascularization (15.3% versus 15.8%, P = 1.0), target vessel revascularization (18.6% versus 23.7%, P = 0.44), non-target vessel revascularization (18.6% versus 26.3%, P = 0.21), and stroke (3.4% versus 4.4%, P = 0.96) between patients assigned to the Yukon Choice and the Taxus Liberté stent. CONCLUSION: At 5 years of follow-up, clinical outcome was similar between the polymer-free sirolimus-eluting Yukon Choice stent and the polymer-based paclitaxel-eluting Taxus Liberté stent.

Characteristics and outcome of primary congenital left ventricular aneurysm and diverticulum: analysis of cases from the literature.

OBJECTIVE: Congenital left ventricular aneurysm (LVA) and diverticulum (LVD) are rare cardiac anomalies. We aimed to analyse the characteristics and long-term outcome of prenatal diagnosed patients with LVA/LVD. METHODS: We performed a systematic review of the literature to identify and analyse patients diagnosed prenatally with LVA/LVD. RESULTS: Twenty-six fetuses with prenatal diagnosis of LVA (50% male subjects) and 16 with LVD (38% male subjects) were identified. Fetal age at diagnosis was 23.8 ± 6.1 weeks. Mean maternal age was 30.6 ± 6.1 years old. LVA was larger (375 ± 237 vs 60 ± 71 mm(2); p = 0.002), and LVA/LVD was frequently observed in an apical location (62%). Associated cardiac/extracardiac defects were reported in 13/42 (31%). Symptomatic patients presented with arrhythmias (LVA 16% vs LVD 0%), hydrops fetalis (LVA 27% vs LVD 18.8%), or rupture (LVA 4% vs LVD 38%; p = 0.02). Size changes of the LVA/LVD during pregnancy were reported in 17%. Fetal death occurred in nine cases (21.4%); termination of pregnancy was performed in six cases (14.3%). All other babies were delivered at term. During follow-up (mean 29.1 ± 38.2 months), the rate of adverse events was significantly increased in patients with LVA (40 vs 0%; p = 0.04) CONCLUSION: The rate of fetal complications including fetal death is high. Long-term outcome among the survivors is significantly worse in patients with LVA.

Intracoronary versus intravenous bolus abciximab during primary percutaneous coronary intervention in patients with acute ST-elevation myocardial infarction: a randomised trial.

BACKGROUND: Intracoronary administration of an abciximab bolus during a primary percutaneous coronary intervention results in a high local drug concentration, improved perfusion, and reduction of infarct size compared with intravenous bolus application. However, the safety and efficacy of intracoronary versus standard intravenous bolus application in patients with ST-elevation myocardial infarction (STEMI) undergoing this intervention has not been tested in a large-scale clinical trial. METHODS: The AIDA STEMI trial was a randomised, open-label, multicentre trial. Patients presenting with STEMI in the previous 12 h with no contraindications for abciximab were randomly assigned in a 1:1 ratio by a central web-based randomisation system to intracoronary versus intravenous abciximab bolus (0·25 mg/kg bodyweight) during percutaneous coronary intervention with a subsequent 12 h intravenous infusion 0·125 µg/kg per min (maximum 10 µg/min). The primary endpoint was a composite of all-cause mortality, recurrent infarction, or new congestive heart failure within 90 days of randomisation. Secondary endpoints were the time to occurrence of the primary endpoint, each individual component of that endpoint, early ST-segment resolution, thrombolysis in myocardial infarction (TIMI) flow grade, and enzymatic infarct size. A masked central committee adjudicated the primary outcome and its components. Treatment allocation was not concealed from patients and investigators. This trial is registered with ClinicalTrials.gov, NCT00712101. FINDINGS: Between July, 2008, and April, 2011, 2065 patients were randomly assigned intracoronary abciximab (n=1032) or intravenous abciximab (n=1033). Intracoronary, as compared with intravenous abciximab, resulted in a similar rate of the primary composite clinical endpoint at 90 days in 1876 analysable patients (7·0%vs 7·6%; odds ratio [OR] 0·91; 95% CI 0·64-1·28; p=0·58). The incidence of death (4·5%vs 3·6%; 1·24; 0·78-1·97; p=0·36) and reinfarction (1·8%vs 1·8%; 1·0; 0·51-1·96; p=0·99) did not differ between the treatment groups, whereas less patients in the intracoronary group had new congestive heart failure (2·4%vs 4·1%; 0·57; 0·33-0·97; p=0·04). None of the secondary endpoints or safety measures differed significantly between groups. INTERPRETATION: In patients with STEMI undergoing primary percutaneous coronary intervention, intracoronary as compared to intravenous abciximab did not result in a difference in the combined endpoint of death, reinfarction, or congestive heart failure. Since intracoronary abciximab bolus administration is safe and might be related to reduced rates of congestive heart failure the intracoronary route might be preferred if abciximab is indicated. FUNDING: Lilly, Germany. University of Leipzig-Heart Centre. University of Leipzig, Clinical Trial Centre Leipzig, supported by the Federal Ministry of Education and Research (BMBF).

Incidence and predictors of pericardial effusion after permanent heart rhythm device implantation: prospective evaluation of 968 consecutive patients.

BACKGROUND: Pericardial effusion (PE) may complicate permanent heart rhythm device (HRD: pacemaker, implantable cardioverter-defibrillator, and cardiac resynchronization therapy) placement. Incidence of and risk factors for this complication have never been prospectively evaluated. METHODS AND RESULTS: The subjects of this prospective observational study were 968 consecutive patients undergoing HRD implantation or upgrade, and underwent echocardiographic evaluation before and 24h after the operation. PE was documented in 98 patients (10%), 14 (1.5%) of whom progressed to cardiac tamponade requiring pericardiocentesis (n=12; 86%) or surgical treatment (n=2; 14%). In 70% (10/14) of those patients a bloody effusion suggested cardiac perforation of an implanted lead; acute pericarditis was observed in the remaining 30% (4/14). At multivariate analysis, female gender (hazard ratio [HR], 2.7; 95% confidence interval [CI]: 1.4-3.5, P=0.01) was predictive in the case of any post-procedural PE, whereas intake of antiplatelet medication (HR, 3.1; 95% CI: 2.1-3.8, P=0.01) was predictive for cardiac tamponade. Previous cardiac surgery (HR, 0.70; 95% CI: 0.50-0.92, P=0.02) was a protective factor in any PE and cardiac tamponade. None of the 84 patients with small or moderate PE required pericardial drainage. After 3.1±0.5 months, a PE was no longer observed at echocardiography in 71% of those patients. CONCLUSIONS: PE is frequently seen after HRD implantation, but rarely requires any therapy. Female gender and antiplatelet therapy are risk factors, whereas previous cardiac surgery was a protective factor.