Search

Background: Permanent pacemaker implantation (PPMI) after transcatheter aortic valve implantation (TAVI) remains an issue open for criticism. Aim of this study is to investigate a strategy to reduce PPMI rate after TAVI in general and more specifically after implantation of the LOTUS ® prosthesis., Methods: Through our learning curve, we have developed a structured protocol to reduce PPMI rate. The protocol includes: shallow implantation depth within the native annulus, strict adherence to the international guidelines for PPMI, PPMI not earlier than 5 days after TAVI, and intravenous chronotropic and steroidal treatment (orciprenaline 0.6-1.7 mg/h i.v. and dexamethasone 25 mg/day i.v. for a maximum of 5 days) in case of acute onset of intraventricular and/or atrio-ventricular conduction disturbances after TAVI., Results: The first 35 patients (group A) were managed as per routine in our early stage experience with the LOTUS valve. The PPMI reduction protocol was applied in the second phase on the last 31 patients (group B). The PPMI rate was reduced from 34.3% (12/35) to 9.7% (3/31) (p = 0.02). At logistic regression analysis being treated in the second phase of our experience (group B) had a protective effect against PPMI (p = 0.05; OR = 0.1; CI = 0.01-1.0). Prosthesis implantation depth was directly related to PPMI (p = 0.005; OR = 2.0; CI = 1.2-3.2). Receiver operating characteristic curve analysis confirmed that a LOTUS implantation depth > 4.8 mm was the cut-off to predict PPMI (AUC = 0.8; p = 0.003; CI = 0.6-0.9) with maximal sensitivity (78.6%) and specificity (73.2%)., Conclusions: PPMI rate after LOTUS can be reduced with experience by applying specific clinical and operative strategies.

Aims: The 6-min walk test (6 MWT) has been established as an important tool for functional assessment in heart failure patients. However, its prognostic impact on the outcome in subjects with mitral regurgitation undergoing transcatheter mitral valve repair is unknown., Methods: This present work represents a sub-analysis of the German, prospective, multicenter, Transcatheter Mitral Valve Interventions (TRAMI) registry. Of the main study cohort (n = 828) 326 patients underwent 6 MWT prior to the procedure. Patients were assigned to two groups depending on the preprocedural 6 MWT distance using the median (< 200 m [group 1] vs. ≥ 200 m [group 2])., Results: No differences regarding procedural success (97 vs. 96%; p = 0.71) and 30-day mortality (3 vs. 4%; p = 0.96) were observed between the groups. With regards to 1-year outcome, patients with a walking distance < 200 m had higher all-cause mortality (26 vs. 14%; p = 0.013) as compared to those with a 6 MWT distance 200 m. After adjustment of baseline risk factors, 6 MWT distance < 200 m still showed a strong trend towards increased 1-year all-cause mortality (HR 1.63, 95% confidence interval 0.96-2.76; p = 0.071)., Conclusions: In the present study preprocedural 6 MWT distance < 200 m showed a strong trend towards increased 1-year mortality in patients undergoing MitraClip implantation.

Aims: The aim of the present study was to assess the safety and efficacy of percutaneous mitral valve repair using the MitraClip™ device in patients with severely reduced systolic left ventricular (LV) function., Methods and Results: Among 777 MitraClip™ implantations included in the German mitral valve registry, we identified 256 patients suffering from severely reduced LV function [ejection fraction (EF) <30%] in whom successful percutaneous mitral valve repair was performed. Procedural safety, efficacy, and 1-year outcome was compared with 241 patients with preserved LV function (EF >50%) and 280 patients presenting with an EF 30-50% prior to MitraClip™ therapy. High procedural success rates, low periprocedural complication rates, and low residual mitral regurgitation grades at discharge were achieved throughout all groups. In-hospital mortality was low and comparable in all groups. After 1 year, mortality rates were 24.2% (EF <30%), 17.3% (EF 30-50%), and 18.9% (EF >50%). Major adverse cardiac or cardiovascular event rates were 29.7% (EF <30%), 24.4% (EF 30-50%), and 23.5% (EF >50%). Procedural failure was the main predictor for mortality in EF <30% patients (hazard ratio 10.38; 95% CI 3.71-29.02). Improved clinical symptoms were observed in the majority of patients in all groups. Thus, 69.5% of EF <30% patients improved by one or more New York Heart Association functional class. Compared with patients with preserved LV function, this is a significantly larger proportion (EF >50%: 56.8%; P < 0.05). Moreover, quality of life, being very poor at baseline, improved distinctively in severe heart failure patients., Conclusion: In patients with severely reduced systolic LV function undergoing MitraClip™ therapy, procedural safety, efficacy, and clinical improvement after 1 year are comparable to patients with preserved LV function., (© 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology.)

Prediction of follow-up shock is crucial to stratify patients with dilated cardiomyopathy (DCM) requiring implantable cardioverter defibrillator (ICD). The objective of the article is to assess the predictive value of endo-myocardial biopsy (EMB) towards ICD shock and follow-up mortality. A series of patients with DCM scheduled for ICD implantation underwent EMB to further determine the genesis of DCM. Presence of fibrosis and inflammation was documented and related to outcomes. A total of 240 patients were referred for ICD as primary (56%) and secondary (44%) prophylaxis. EMB showed myocardial fibrosis in 55.4%, inflammation in 55.7%, and viral genomic material in 60%. Median follow-up was 39 months (1-209). Appropriate and inappropriate shocks occurred in 29.2 and 20.4%. At logistic regression, determinants of appropriate shock were ICD indication for secondary prophylaxis (direct relationship: p = 0.009, OR 3.4, CI 1.3-8.8) and presence of inflammation at EMB (inverse relationship: p = 0.04, OR 0.4, CI 0.1-0.9). Moreover, the sole determinant of inappropriate shock was age at implant (inverse relationship: p = 0.003, OR = 0.9, CI 0.90-0.98). Overall mean estimated survival was 168 months and 5-year survival was 83%. Degree of improvement in LVEF% was the sole determinant of follow-up mortality (inverse relationship p = 0.02; HR = 0.9; CI 0.88-0.99). Present selection criteria for ICDs implant rely mainly on LVEF% that lacks sensitivity and specificity. EMB can identify the substrate of increased or reduced life-threatening arrhythmias. Presence of inflammation is a positive prognostic factor for reduced arrhythmogenic risk, independently by the ICD implantation indication.

Objectives: The study aim is to present the long-term performance of a new generation implantable cardioverter defibrillator (ICD) electrode with floating atrial dipole (Linox S DX, Biotronik, Berlin, Germany)., Background: The single ICD electrode with a floating dipole in the atrial chamber was introduced about 15 years ago to overcome risk of inappropriate shock., Methods: After implantation, internal electrocardiogram data were prospectively collected via telemonitoring (Home Monitoring, Biotronik)., Results: A total of 93 patients (81.5% male, 18.5% female; 58.9 ± 12.3 years) were implanted with a single-chamber ICD using the Linox S DX. Patients were followed up for a median of 693 days (33-2,460 days). At time of implantation average p-wave value was 3.5 ± 1.7 mV and remained stable throughout follow-up with an average value of 3.7 ± 1 mV (P = 0.2). A total of 460 arrhythmic episodes were recorded and 185 (40.2%) were incorrectly stratified by the device software. Seven patients (7.5%) experienced inappropriate ICD therapy. In three patients, VT episodes were not detected and remained untreated., Conclusions: Although the Linox S DX lead presents a satisfactory long-term stability of the atrial sensing, many of the messages sent to the device during follow-up were incorrectly classified by the ICD software. As a result, inappropriate therapy occurred with a rate similar to that observed with dual-chamber ICDs, but some malignant arrhythmias remained undiagnosed and untreated while occurring. Results in larger prospective cohorts should be analyzed and software improvements of the device should be suggested to overcome these potential drawbacks., (© 2017 Wiley Periodicals, Inc.)

Background: Drug-eluting stents (DES) compared to bare metal stents (BMS) have shown superior clinical performance, but are considered less suitable in complex cases. Most studies do not distinguish between DES and BMS with respect to their mechanical performance. The objective was to obtain mechanical parameters for direct comparison of BMS and DES., Methods: In vitro bench tests evaluated crimped stent profiles, crossability in stenosis models, elastic recoil, bending stiffness (crimped and expanded), and scaffolding properties. The study included five pairs of BMS and DES each with the same stent platforms (all n = 5; PRO-Kinetic Energy, Orsiro: BIOTRONIK AG, Bülach, Switzerland; MULTI-LINK 8, XIENCE Xpedition: Abbott Vascular, Temecula, CA; REBEL Monorail, Promus PREMIER, Boston Scientific, Marlborough, MA; Integrity, Resolute Integrity, Medtronic, Minneapolis, MN; Kaname, Ultimaster: Terumo Corporation, Tokyo, Japan). Statistical analysis used pooled variance t tests for pairwise comparison of BMS with DES., Results: Crimped profiles in BMS groups ranged from 0.97 ± 0.01 mm (PRO-Kinetic Energy) to 1.13 ± 0.01 mm (Kaname) and in DES groups from 1.02 ± 0.01 mm (Orsiro) to 1.13 ± 0.01 mm (Ultimaster). Crossability was best for low profile stent systems. Elastic recoil ranged from 4.07 ± 0.22% (Orsiro) to 5.87 ± 0.54% (REBEL Monorail) including both BMS and DES. The bending stiffness of crimped and expanded stents showed no systematic differences between BMS and DES neither did the scaffolding., Conclusions: Based on in vitro measurements BMS appear superior to DES in some aspects of mechanical performance, yet the differences are small and not class uniform. The data provide assistance in selecting the optimal system for treatment and assessment of new generations of bioresorbable scaffolds., Trial Registration: not applicable.

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., (Copyright © 2017 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.)

Aims: RESPOND is a prospective, open-label, single-arm study evaluating the outcomes following transcatheter aortic valve implantation (TAVI) with the repositionable and fully retrievable Lotus Valve used in routine clinical practice for the treatment of patients with aortic valve stenosis., Methods and Results: RESPOND enrolled 1014 patients at sites across Europe, New Zealand, and Latin America; 996 patients received a Lotus Valve (mean age: 80.8 years; 50.8% female; Society of Thoracic Surgeons score: 6.0 ± 6.9). Repositioning was attempted in 29.2% of patients, with 99% success. The rate of all-cause mortality in the intent-to-treat population at 30 days (primary endpoint) was 2.6% (P < 0.001 vs. pre-specified performance goal). Thirty-day clinical follow-up was completed for 97.3% of patients. Among patients who received a Lotus Valve, the 30-day overall and disabling stroke rates were 3.0% and 2.2%, respectively. The 30-day permanent pacemaker implantation rate was 30.0% in all patients, and 34.6% in pacemaker-naïve patients. Echocardiographic data at baseline and pre-discharge were assessed by an independent core laboratory. Mean aortic valve gradient declined from 37.7 ± 15.2 mmHg at baseline to 10.8 ± 4.6 mmHg at hospital discharge (P < 0.001). Aortic valve area increased from 0.7 ± 0.2 cm2 at baseline to 1.8 ± 0.4 cm2 at discharge (P < 0.001). At hospital discharge, paravalvular leak (PVL) was absent or trace in 92% of patients; no patients had severe PVL, 0.3% of patients exhibited moderate PVL, and 7.7% of patients had mild PVL. Clinical follow-up in RESPOND will extend to 5 years., Conclusion: The results of RESPOND confirm the safety and efficacy of TAVI with the Lotus Valve in routine clinical practice., Trial Registration: ClinicalTrials.gov #NCT 02031302., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.)

Objectives: In contrast to stented transcatheter aortic valves, the Direct Flow Medical (DFM) valve is a stentless bovine aortic bioprosthesis mounted in a non-metallic inflatable frame. Hence, severe asymmetric annular calcification may result in residually elevated transaortic pressure gradients after DFM implantation. We present a novel intraprocedural dilatation (IDIL) technique for successful implantation of the DFM valve in the presence of complex annular calcification., Methods: Between January 2014 and May 2015, 55 patients underwent DFM valve-based transcatheter aortic valve implantation at our institution. Of these, 5 patients required an IDIL technique due to a residual intraoperative transaortic pressure mean gradient above 15 mmHg. The mean patient age was 73 ± 8.2 years; the mean logistic EuroSCORE was 24.5 ± 8.2% and the mean Society of Thoracic Surgeons score was 6.3 ± 4.3%., Results: The IDIL technique immediately attenuated transvalvular mean pressure gradients from 20 ± 2 mmHg to 6 ± 1 mmHg. The results remained stable during the 30-day observation period at 10 ± 3 mmHg. Minimal paravalvular aortic regurgitation (trace) was detected in 2 patients. No in-hospital deaths were observed., Conclusions: The IDIL technique facilitates safe DFM valve implantation in patients with complex asymmetric annular calcification without adverse side effects on valve structure or performance in short-term follow-up., (© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) has been popularized as a precious patients' management tool. We have investigated RM within the premises of a multicenter, prospective, real-world registry, i.e., the German Device II., Methods: We have focused on: (1) CIEDs with RM capabilities implantation rate and (2) actual rate of RM features activation., Results: A cohort of 1223 CIEDs patients were treated from 04/11 to 02/14. Of these, 720 (58.8%) were implanted with RM-capable devices and were presenting significantly more often a clinical diagnosis of dilatative cardiomyopathy and an indication for cardiac resynchronization. At discharge, the RM feature was activated in only 12.6% (91/720) of the total number of patients implanted with RM-capable CIEDs. After adjusting for implanting center, there was no significant correlation between any of the patient clinical characteristics and RM activation. One-year estimated mortality was 9.0% in patients with activated RM, 5.6% in those with not activated RM, and 7.7% in those without RM capability (p = 0.3). The RM feature was still activated in 13.8% of the patients surviving at follow-up. Patients undergoing RM had a trend for higher re-hospitalization rate and less visits in the device outpatient clinic., Conclusions: Although RM in CIEDs may be a clinically valuable technological armamentarium, its activation does not reflect patients' clinical profile. In fact, RM is often not activated, most probably because it is still recognized as a source of increased workload in a reality where reimbursement plans for dedicated human resources are not yet optimized.

The treatment of mitral regurgitation has changed in recent years due to the advent of interventional techniques, mostly the percutaneous edge-to-edge repair, and, more recently, annuloplasty and chordal replacement. In the future, more advances are expected from further development of interventional techniques, careful evaluation and better patient selection.

Aims: While LAA closure has recently been incorporated into both European and US guidelines for stroke prevention, uncertainties regarding post-procedural drug therapy so far limit its adoption. The aim of this analysis is to compare real-world outcome data stratified for the post-procedural drug regimen employed., Methods and Results: One thousand and five patients were implanted with a WATCHMAN device in the prospective EWOLUTION study at 47 centres; 73.5% of the patients were deemed contraindicated for long-term OAC therapy. Here we report on three-month data including the first follow-up TOE exam for 94% of the study population. Following LAA closure, patients received DAPT, VKA, NOAC, single antiplatelet or no therapy (60.3%, 15.4%, 10.9%, 7% and 6.5%, respectively). Device thrombus (2.6%), stroke (0.4%) and major bleeding SAE (2.6%) rates were low overall and did not vary by post-implantation medication strategy. Patients on NOAC had the lowest bleeding rate, without an increase in device thrombus or stroke rates., Conclusions: LAA closure with the WATCHMAN device is feasible in patients with a relative or absolute contraindication to oral anticoagulation. Neither DAPT nor NOAC therapy leads to a significant increase in device thrombus, stroke or bleeding compared to the standard VKA regimen. Numerically, NOAC therapy had the lowest event rate.

Many patients with severe aortic stenosis have a "low-flow, low-gradient" aortic stenosis. The management of these patients can be quite difficult, as these patients often show impairment of the left ventricle, which can lead to false measurements of the severity of stenosis and also leads to a higher risk during aortic valve replacement. More diagnostic tools than only standard echocardiography are needed to correctly differentiate true severe aortic stenosis from pseudo severe aortic stenosis.

Background: Left atrial appendage (LAA) occlusion with WATCHMAN has emerged as viable alternative to vitamin K antagonists in randomized controlled trials., Objective: EWOLUTION was designed to provide data in routine practice from a prospective multicenter registry., Methods: A total of 1025 patients scheduled for a WATCHMAN implant were prospectively and sequentially enrolled at 47 centers. Indication for LAA closure was based on European Society of Cardiology guidelines. Follow-up and transesophageal echocardiography (TEE) were performed per local practice., Results: The baseline CHA 2 DS 2 -VASc score was 4.5 ± 1.6; the mean age was 73.4 ± 9 years; previous transient ischemic attack/ischemic stroke was present in 312 (30.5%), 155 (15.1%) had previous hemorrhagic stroke, and 320 (31.3%) had a history of major bleeding; and 750 (73%) were deemed unsuitable for oral anticoagulation therapy. WATCHMAN implant succeeded in 1005 (98.5%) of patients, without leaks >5 mm in 1002 (99.7%) with at least 1 TEE follow-up in 875 patients (87%). Antiplatelet therapy was used in 784 (83%), while vitamin K antagonists were used in only 75 (8%). At 1 year, mortality was 98 (9.8%), reflecting the advanced age and comorbidities in this population. Device thrombus was observed in 28 patients at routine TEE (3.7%) and was not correlated with the drug regimen (P = .14). Ischemic stroke rate was 1.1% (relative risk 84% vs estimated historical data); the major bleeding rate was 2.6% and was predominantly (2.3%) nonprocedure/device related., Conclusion: LAA closure with the WATCHMAN device has a high implant and sealing success. This method of stroke risk reduction appears to be safe and effective with an ischemic stroke rate as low as 1.1%, even though 73% of patients had a contraindication to and were not using oral anticoagulation., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Aims: The aim of this study was to identify the impact of previous aortic valve replacement (AVR) in MitraClip (MC) patients., Methods and Results: Data from the German transcatheter mitral valve interventions (TRAMI) registry were analysed in the light of previous AVR by means of either standard AVR (SAVR) or transcatheter AVR (TAVR). Out of 791 MC patients, 68 (8.6%) had been submitted to AVR (68.4% SAVR and 31.6% TAVR). The AVR group was significantly older (77.2±8.0 years vs. 75.1±8.6 years; p<0.05) and had a trend towards a higher risk profile (median STS score 10 [8.0-12.0] vs. 6.0 [3.0-11.0]; p=0.1). No procedural mortality was observed. Severe residual MV regurgitation was reported in 6.2% of AVR vs. 3.7% of the no-AVR patients (p=0.1). Thirty-day mortality was 10.6% in the previous AVR group vs. 3.9% in the no-AVR group (p<0.05). One-year estimated survival was lower in the AVR group (AVR 63% vs. no-AVR 81%; p<0.0001; HR 2.25, 95% CI: 1.42-3.55). Estimated survival in TAVR compared to SAVR was lower (TAVR 44.4% vs. SAVR 70%; p=0.039; HR 2.32, 95% CI: 0.99-5.37). AVR was a determinant of follow-up mortality (HR 2.18, 95% CI: 1.4-3.4; p<0.001)., Conclusions: Previous AVR in patients undergoing MC therapy carries a heavy and independent burden of mortality/morbidity.

Aims: We aimed to assess the safety and performance of the DREAMS 2G scaffold up to 24 months post implant., Methods and Results: The present study population comprises a total of 184 patients with 189 lesions who were enrolled in the prospective, multicentre BIOSOLVE-II and BIOSOLVE-III trials. Clinical follow-up was scheduled at one, six, 12, 24 and 36 months. The present report includes pooled follow-up data at six months and BIOSOLVE-II data at 24 months. Patients were 65.5±10.8 years old, and lesions were 12.5±5.1 mm long with reference diameters of 2.7±0.4 mm. Procedural success was obtained in 97.8%. At six months, the composite clinical endpoint target lesion failure was 3.3% (95% CI: 1.2-7.1), based on two cardiac deaths (1.1%, one unknown and one not device-related), one target vessel myocardial infarction (0.6%), and three clinically driven target lesion revascularisations (1.7%). For BIOSOLVE-II at 24 months, the target lesion failure rate was 5.9% (95% CI: 2.4-11.8), based on two cardiac deaths (1.7%), one target vessel myocardial infarction (0.9%) and four target lesion revascularisations (3.4%). There was no definite or probable scaffold thrombosis., Conclusions: The present analysis provides additional evidence on the safety of a drug-eluting absorbable metal scaffold with promising clinical outcomes up to 24 months and absence of definite or probable scaffold thrombosis.

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., (© 2016 John Wiley & Sons Ltd.)

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.

Background: The Parachute is a novel percutaneously implanted ventricular partitioning device (VPD) that has emerged as a safe and feasible treatment option for patients with heart failure following anterior wall myocardial infarction. VPD efficacy is likely dependent on optimal device placement, but to date there are no published data examining the effect of device positioning on patient outcomes., Methods and Results: We retrospectively identified 32 patients successfully implanted with the Parachute device, all of whom underwent cardiac computed tomography (CCT) at baseline and after 6 months of follow-up. Patients were divided into two groups based on self-reported improvement in New York Heart Association (NYHA) functional class: "not improved NYHA" (n = 12) and "improved NYHA" (n = 20). There were significant differences between both groups with regard to device positioning on follow-up CCT. Compared to patients with "improved NYHA," patients with "not improved NYHA" had longer distances from device foot to left ventricular apex (8.0 ± 4.9 vs. 2.9 ± 4.6 mm; P = 0.01), and higher lateral angles (18.0 ± 14 vs. 9.1 ± 6.8 degrees; P = 0.02), respectively. There was no significant difference between the two groups in landing zone (45.4 ± 7. vs. 45.1 ± 6.9 mm; P = 0.92) and inferior angle (14.0 ± 11.9 vs. 14.3 ± 10.1 degrees; P = 0.95). There was a numerically larger malapposition area in the "not improved NYHA" group (5.1 ± 4.5 vs. 3.2 ± 2.2 cm2; P = 0.12)., Conclusion: Quality of Parachute implant impacted clinical outcome, these findings should be applied prospectively in helping operators to achieve optimal implant. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Objectives: To analyze our single center experience with the Direct Flow Medical (DFM)., Background: The DFM has been recently introduced to the market and large real world experiences are lacking., Methods: A total of 126 patients with severe aortic valve stenosis (AVS) were treated by the same team from March 2013 to May 2015. Device success and procedural safety were classified, according to valve academic research consortium (VARC) criteria, for the entire cohort, including patients treated in the early phases of our learning curve., Results: Clinical and trans-thoracic echocardiography follow-up was performed (median duration 279 days; 36-761 days). Mean age was 80.9 ± 5.5 years and median logistic Euro-SCORE was 15.9 (5.5-84.2). Cardiovascular 30-day mortality was 4.8% (6/126), device success 89.6% (113/126), and early safety 85.7% (108/126). At discharge, no aortic regurgitation (AR) was present in 85.7% and mild AR in 14.3% of the patients. Estimated 1-year follow-up survival was 91%. At follow-up, no AR was present in 87.3%, mild AR in 10.9%, and moderate AR in 1.8%. Mean gradient of 15.1 ± 6.3 mm Hg and prosthesis effective orifice area of 1.6 ± 0.6 cm 2 were reported., Conclusions: In this single center experience, the DFM valve showed satisfactory clinical and hemodynamic results. Short-term follow-up confirmed the consistent clinical results, with low rates of AR and acceptable trans-prosthetic gradients and prosthetic effective orifice area. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

The MitraClip system is a device for percutaneous edge-to-edge reconstruction of the mitral valve in patients with severe mitral regurgitation who are deemed at high risk for surgery. Studies have underlined the therapeutic benefit of the MitraClip system for patients at extreme and high risk for mitral valve surgery, suffering from either degenerative or functional mitral regurgitation. The MitraClip procedure shows low peri-procedural complication rates, and a significant reduction in mitral regurgitation, as well as an improvement in functional capacity and most importantly quality of life. It hereby widens the spectrum of mitral valve repair for the Heart Team. The current review underscores the efficacy of the procedure and describes the technique to simplify the procedure., Competing Interests: The authors declare that there is no conflict of interest.

Outcomes of acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) have been significantly improved with the use of potent P2Y 12 receptor inhibitors like prasugrel. While most of the ischaemic risk reduction for prasugrel versus clopidogrel was demonstrated in the early treatment period, the risk of bleeding became particularly prominent during the chronic course of therapy. It may therefore be a valid approach to substitute prasugrel for clopidogrel in the early phase of chronic antiplatelet treatment after PCI. In the Testing Responsiveness To Platelet Inhibition On Chronic Antiplatelet Treatment For Acute Coronary Syndromes (TROPICAL-ACS) trial, we aim to compare standard prasugrel therapy with a de-escalating antiplatelet treatment approach guided by platelet function testing (PFT). The study is an investigator-initiated European multicentre, randomised clinical trial in biomarker-positive ACS patients after successful PCI. Two thousand six hundred patients will be randomised prior to hospital discharge in a 1:1 fashion to either receive standard prasugrel therapy (control group) or de-escalating therapy (one-week prasugrel followed by one-week clopidogrel and PFT-guided maintenance therapy from day 14 after hospital discharge, monitoring group). Patients of the monitoring group with high on-clopidogrel platelet reactivity (HPR) based on Multiplate analyzer testing (HPR: ≥ 46U per consensus definition) will be switched back to prasugrel, whereas those without HPR (<46 U) will continue clopidogrel treatment. The overall study treatment duration will be one year in both groups. The primary endpoint of the study is net clinical benefit (combined incidence of cardiovascular death, myocardial infarction, stroke and bleeding ≥ grade 2 according to BARC criteria) one-year after randomisation. TROPICAL-ACS is the first large-scale, randomised controlled trial assessing the clinical value of a PFT-guided de-escalation of antiplatelet treatment in biomarker positive ACS patients undergoing PCI.

Objectives: We present our single center experience with the direct flow medical (DFM) prosthesis addressing the impact of native aortic valve (AV) calcification degree on outcomes., Background: The DFM® has been introduced for transcatheter aortic valve implantation (TAVI). The valve has a nonmetallic and inflatable support structure., Methods: Patients were divided in two groups according to preoperative cardiac computed tomography (CT): group I moderate calcification and group II heavy calcification of the total AV area. We evaluated 118 patients: 53 (45%) group I and 65 (55%) group II., Results: Preoperative trans-AV gradient and calcification extension across the aortic unit were significantly higher in group II (P = 0.008 and P < 0.0001). CT perimeter derived annular diameter (group I 24.7 ± 2.1 mm vs. group II 24.8 ± 1.9; P = 0.6) and implanted prosthesis size (group I 26.1 ± 1.5 mm vs. group II 25.7 ± 1.5; P = 0.1) were similar. Hemodynamics were similar: mean gradient 16.1 ± 5.9 mm Hg (group I) vs. 17.3 ± 6.5 mm Hg (group II) (P = 0.3). Total aortic regurgitation (AR) was mild in 5.7% in group I and 20% in group II (P = 0.03). None developed moderate/severe AR. Heavy AV calcification was the sole independent determinant for mild regurgitation (P = 0.02; OR = 7; 95% CI: 1.2-37.6). Follow-up (289 days; 40-760 days) estimated survival was 88.1% (group I) and 93.8% (group II) (P = 0.3)., Conclusions: Independent of AV calcification degree, adequate sizing and implantation can be achieved with the DFM®. Although higher burden of calcification increases the rate of mild AR, no patient developed moderate and severe AR. Short-term estimated survival was not influenced by calcification degree. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Aims: Stem cell-based regenerative therapies for the treatment of ischemic myocardium are currently a subject of intensive investigation. A variety of cell populations have been demonstrated to be safe and to exert some positive effects in human Phase I and II clinical trials, however conclusive evidence of efficacy is still lacking. While the relevance of animal models for appropriate pre-clinical safety and efficacy testing with regard to application in Phase III studies continues to increase, concerns have been expressed regarding the validity of the mouse model to predict clinical results. Against the background that hundreds of preclinical studies have assessed the efficacy of numerous kinds of cell preparations - including pluripotent stem cells - for cardiac repair, we undertook a systematic re-evaluation of data from the mouse model, which initially paved the way for the first clinical trials in this field., Methods and Results: A systematic literature screen was performed to identify publications reporting results of cardiac stem cell therapies for the treatment of myocardial ischemia in the mouse model. Only peer-reviewed and placebo-controlled studies using magnet resonance imaging (MRI) for left ventricular ejection fraction (LVEF) assessment were included. Experimental data from 21 studies involving 583 animals demonstrate a significant improvement in LVEF of 8.59%+/- 2.36; p=.012 (95% CI, 3.7-13.8) compared with control animals., Conclusion: The mouse is a valid model to evaluate the efficacy of cell-based advanced therapies for the treatment of ischemic myocardial damage. Further studies are required to understand the mechanisms underlying stem cell based improvement of cardiac function after ischemia., (© 2017 The Author(s). Published by S. Karger AG, Basel.)

Aims: Our aim was to assess the clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System (DFM-TAVS), when used in routine clinical practice., Methods and Results: This is a prospective, open-label, multicentre, post-market registry of patients treated with DFM-TAVS according to approved commercial indications. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events were adjudicated and classified according to VARC-2 criteria by an independent clinical events committee. The primary endpoint was freedom from all-cause mortality at 30 days post procedure. Secondary endpoints included procedural, early safety and efficacy endpoints at 30 days. Two hundred and fifty patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) with the DFM-TAVS were enrolled in 21 European centres. The primary endpoint, freedom from all-cause mortality at 30 days, was met in 98% (245/250) of patients. Device success was 83.8%. Moderate or severe aortic regurgitation was reported in 3% of patients, and none/trace regurgitation in 73% of patients. Post-procedural permanent pacemaker implantation was performed in 30 patients (12.0%)., Conclusions: The DFM-TAVS was associated with good short-term outcomes in this real-world registry. The low pacemaker and aortic regurgitation rates confirm the advantages of this next-generation transcatheter heart valve (THV).

Background: Second-generation TAVI prostheses may enhance the procedure reducing operative time and complications rate, maintaining adequate valve hemodynamic performance. We present our results with 2 new generation trans-catheter aortic valve (TAVI) prostheses in obese patients., Methods: A series of 172 patients underwent trans-femoral TAVI with new generation prostheses (Direct Flow Medical, DFM®, and LOTUS®). Two groups were identified according to body mass index (BMI): group NO (125) BMI<30kg/m(2) and group O (47) BMI≥30kg/m(2)., Results: Trans-femoral approach was possible in all patients without conversion to conventional surgery/cardiopulmonary bypass. Operative/fluoroscopy time and contrast use were comparable. Vascular and bleeding complications were also equally represented in the 2 groups. Thirty-day mortality was 7.2% in group NO and 6.4% in group O (p=0.9). At discharge, aortic regurgitation was absent/mild in 96% of group NO and in all patients in group O (p=0.3). Mild prosthetic stenosis was reported in 3.8% of the patients in group NO and 2.2% in group O. No moderate/severe prosthetic stenosis was reported. Estimated 1-year survival was 93.1% in group NO and 83.2% in group O (p=0.6). Estimated 1-year freedom from MACCE was 74.7% in group NO and 62.8% in group O (p=0.4). At follow-up echocardiography no significant differences were noticed in the 2 groups., Conclusions: Second generation TAVI prostheses allow for safe and effective procedures in obese patients. In spite of patient's body habitus, agile prosthesis placement will lead to optimized hemodynamics. Valve and clinical performance are confirmed at follow-up., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Aims: Metal absorbable scaffolds constitute a conceptually attractive alternative to polymeric scaffolds. Promising 6-month outcomes of a second-generation drug-eluting absorbable metal scaffold (DREAMS 2G), consisting of an absorbable magnesium scaffold backbone, have been reported. We assessed the 12-month safety and performance of this novel device., Methods and Results: The prospective, international, multi-centre, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to two de novo lesions with a reference diameter between 2.2 and 3.7 mm. All patients were scheduled for angiographic follow-up at 6 months, and-if subjects consented-at 12 months. Dual antiplatelet therapy was recommended for 6 months. Quantitative coronary angiography (QCA) parameters remained stable from 6 to 12 months [paired data of 42 patients: in-segment late lumen loss 0.20 ± 0.21 mm vs. 0.25 ± 0.22 mm, P = 0.117, Δ 0.05 ± 0.21 mm (95% CI: -0.01;0.12); in-scaffold late lumen loss 0.37 ± 0.25 mm vs. 0.39 ± 0.27 mm, P = 0.446, Δ 0.03 ± 0.22 (95% CI: -0.04;0.10), respectively]. Intravascular ultrasound and optical coherence tomography findings corroborated the QCA results. Target lesion failure occurred in four patients (3.4%), consisting of one death of unknown cause, one target-vessel myocardial infarction, and two clinically driven target lesion revascularization. No additional event occurred beyond the 6-month follow-up. During the entire follow-up of 12 months, none of the patients experienced a definite or probable scaffold thrombosis., Conclusion: The novel drug-eluting metal absorbable scaffold DREAMS 2G showed a continuous favourable safety profile up to 12 months and stable angiographic parameters between 6 and 12 months., Clinicaltrialsgov Identifier: NCT01960504., (© The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.)

The demographic changes in society lead to an increasing number of patients with aortic valve stenosis and mitral regurgitation. Simultaneously the higher age of patients is associated with an increase in multimorbidity with a high surgical risk so that they cannot be referred to surgery. Besides the current gold standard of surgery, minimally invasive therapeutic options are increasingly becoming established for these patients. For the differentiated indications and therapeutic success, a multidisciplinary heart team assumes an important role. The next generation of transcatheter aortic valve implantation (TAVI) systems will lead to improvement in the results, lower complication rates and mortality and as a result there is a general trend towards expanding the indications. New innovative minimally invasive mitral valve devices are still undergoing clinical trials and will define future therapy options.

Objectives: The aim of current study is to assess the near term impact of percutaneous ventricular restoration therapy (PVR), Parachute(®) on mitral valve (MV) geometry by cardiac computed tomography (CCT)., Background: Recent data demonstrates the feasibility of PVR for treatment of post anterior myocardial infarction (MI) heart failure. Little is known, however, about the interaction of the device and left ventricular structures, particularly the MV apparatus., Methods: This is a retrospective Core Laboratory analysis of Parachute Trials' CCT data. Patients with paired (before and after Parachute implant) CCT acquisitions were included into analysis. MV geometric parameters were measured., Results: Thirty-three patients were included in the analysis. The mean time of follow-up CCT post procedure was 188 ± 52 days. There were significant reduction in tenting height (A1P1: -1.70 ± 1.89 mm, -17.40 ± 20.20%; A2P2: -1.43 ± 1.89 mm, -12.10 ± 15.00%; A3P3: -1.54 ± 1.58 mm, -15.50 ± 15.20%, P < 0.001), tenting volume (-0.93 ± 0.60 mm3, -22.00 ± 11.40%, P < 0.001), systolic interpapillary muscle distance (-2.22 ± 2.11 mm, -7.51 ± 7.23%, P < 0.001) and diastolic interpapillary muscle distance (-3.14 ± 2.20 mm, -8.46 ± 5.73%, P < 0.001) post PVR., Conclusions: In post anterior MI heart failure patients, PVR has favorable near term impact on MV geometry as assessed by CCT. © 2015 Wiley Periodicals, Inc., (© 2015 Wiley Periodicals, Inc.)

Aim: MULTIPRAC was designed to provide insights into the use and outcomes associated with prehospital initiation of antiplatelet therapy with either prasugrel or clopidogrel in the context of primary percutaneous coronary intervention. After a previous report on efficacy and safety outcomes during hospitalization, we report here the 1-year follow-up data, including cardiovascular (CV) mortality., Methods and Results: MULTIPRAC is a multinational, prospective registry of patients with ST-elevation myocardial infarction (STEMI) from 25 hospitals in nine countries, all of which had an established practice of prehospital start of dual antiplatelet therapy in place. The key outcome was CV death at 1 year. Among 2,036 patients followed-up through 1 year, 49 died (2.4%), 10 during the initial hospitalization and 39 within 1 year after hospital discharge. The primary analysis was based on the P2Y12-inhibitor, used from prehospital loading dose through hospital discharge. Prasugrel (n=824) was more commonly used than clopidogrel (n=425). The observed 1-year rates for CV death were 0.5% with prasugrel and 2.6% with clopidogrel. After adjustment for differences in baseline characteristics, treatment with prasugrel was associated with a significantly lower risk of CV death than treatment with clopidogrel (odds ratio 0.248; 95% confidence interval 0.06-0.89)., Conclusion: In STEMI patients from routine practice undergoing primary angioplasty, who were able to start oral antiplatelet therapy prehospital, treatment with prasugrel as compared to clopidogrel was associated with a lower risk of CV death at 1-year follow-up.

Transcatheter aortic valve implantation (TAVI) is an established and approved procedure with an increasing implantation rate, whilst the number of surgical aortic valve replacements (SAVR) remained unchanged (AQUA data). This demonstrates that more patients who were unsuitable for SAVR were treated with TAVI. First randomized trials have shown a significant survival benefit for TAVI compared to conservative therapy (PARTNER B) and non-inferiority to SAVR in high-risk patients (PARTNER A). The US pivotal trials demonstrated even a significant survival benefit in TAVI patients compared to SAVR. The current 5-year data of the PARTNER trials demonstrate a long-term durability of the TAVI valves, which even have superior hemodynamic parameters. Increasing experience, optimization and evolution of the TAVI systems lead to better results and lower rates of complications and mortality, as was shown by the "real world data" from the German aortic valve registry (GARY). The analysis of the subgroups and also the Nordic aortic valve intervention (NOTION) study showed equivalent results for TAVI and SAVR in patients with intermediate and low risk. There is a trend to expand the indications to patients with intermediate risk and the currently ongoing large prospective and randomized trials SURTAVI and PARTNER II could provide greater clarity.

Objectives: We present our experience with an inflatable, non-metallic, fully retrievable, and repositionable transcatheter aortic valve [Direct Flow® Medical (DFM)] focusing on technical features adopted during implantation., Background: Implantation techniques of new generation percutaneous aortic valves are still developing and with experience implementations are described., Methods: The "low pressure" (initial valve inflation at 4 ATM, lower than the recommended 12 ATM) and the "alternate aortic curve" techniques (initial valve pulling either from the wire running on the side of the inner or from the one on the outer aortic curve) are part of our modified protocol for DFM® implantation., Results: Forty-two consecutive patients underwent TAVI with DFM. The "low pressure" technique was used in all patients. In 27 (64.3%) patients the bulkiest calcifications were on the inner aortic curve side, and an inner curve technique was used to initiate valve pulling toward the annular hinge point. In the remaining 15 (35.7%) patients, an outer curve technique was used. Neither pull-through nor re-valving was reported. Valve performance showed mean gradient of 8.9 mm Hg. Mild paravalvular leak was reported in seven (16%) patients. No one experienced moderate or severe aortic insufficiency. Thirty-day mortality was 9.5% (4/42)., Conclusion: The "low pressure technique" and the "alternate curve technique" guarantee an anatomy and patient tailored approach to achieve controlled and finely tuned valve seating., (© 2015 Wiley Periodicals, Inc.)

Aims: Our aim was to assess the performance of the Direct Flow Medical (DFM) repositionable and retrievable transcatheter aortic valve implantation (TAVI) system in high-risk patients with severe aortic stenosis., Methods and Results: One hundred and five consecutive high-risk patients with severe aortic stenosis undergoing TAVI with the DFM prosthesis were enrolled in six high-volume TAVI centres in Germany, Italy, The Netherlands, Belgium, and Luxembourg. The "inner curve" technique was systematically used in all patients. The primary endpoint was all-cause mortality at 30 days of clinical follow-up. Secondary endpoints for the same time frame were: (i) VARC-2-defined patient safety; and (ii) VARC-2-defined device success. The primary endpoint of all-cause mortality at 30 days was met in 1.9% (two patients). The VARC-2-defined device success rate was 98.1%. The combined patient safety endpoint was met in 88.6%. Residual moderate aortic regurgitation was observed in 1.9% (two patients). Permanent pacemaker implantation due to post-procedural persistent advanced atrioventricular block was performed in 9.5% (10 patients)., Conclusions: In a multicentre, real-world clinical setting of high-risk patients with severe aortic stenosis, a repositionable and retrievable TAVI system was effective and safe in the short-term follow-up.

Background: Absorbable scaffolds were designed to overcome the limitations of conventional, non-absorbable metal-based drug-eluting stents. So far, only polymeric absorbable scaffolds are commercially available. We aimed to assess the safety and performance of a novel second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de-novo coronary artery lesions., Methods: We did this prospective, multicentre, non-randomised, first-in-man trial at 13 percutaneous coronary intervention centres in Belgium, Brazil, Denmark, Germany, Singapore, Spain, Switzerland, and the Netherlands. Eligible patients had stable or unstable angina or documented silent ischaemia, and a maximum of two de-novo lesions with a reference vessel diameter between 2·2 mm and 3·7 mm. Clinical follow-up was scheduled at months 1, 6, 12, 24, and 36. Patients were scheduled for angiographic follow-up at 6 months, and a subgroup of patients was scheduled for intravascular ultrasound, optical coherence tomography, and vasomotion assessment. All patients were recommended to take dual antiplatelet treatment for at least 6 months. The primary endpoint was in-segment late lumen loss at 6 months. We did analysis by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01960504., Findings: Between Oct 8, 2013, and May 22, 2015, we enrolled 123 patients with 123 coronary target lesions. At 6 months, mean in-segment late lumen loss was 0·27 mm (SD 0·37), and angiographically discernable vasomotion was documented in 20 (80%) of 25 patients. Intravascular ultrasound assessments showed a preservation of the scaffold area (mean 6·24 mm(2) [SD 1·15] post-procedure vs 6·21 mm(2) [1·22] at 6 months) with a low mean neointimal area (0·08 mm(2) [0·09]), and optical coherence tomography did not detect any intraluminal mass. Target lesion failure occurred in four (3%) patients: one (<1%) patient died from cardiac death, one (<1%) patient had periprocedural myocardial infarction, and two (2%) patients needed clinically driven target lesion revascularisation. No definite or probable scaffold thrombosis was observed., Interpretation: Our findings show that implantation of the DREAMS 2G device in de-novo coronary lesions is feasible, with favourable safety and performance outcomes at 6 months. This novel absorbable metal scaffold could be an alternative to absorbable polymeric scaffolds for treatment of obstructive coronary disease., Funding: Biotronik AG., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Background: Accurate preoperative assessment of the aortic annulus dimension is crucial for successful transcatheter aortic valve implantation (TAVI). In this study we examined the accuracy of a novel method using two-dimensional transesophageal echocardiography (2D-TEE) for measurement of the aortic annulus., Methods: We evaluated the theoretical impact of the measurement of the annulus diameter and area using the circumcircle of a triangle method on the decision to perform the procedure and choice of the prosthesis size., Results: Sixty-three consecutive patients were scheduled for TAVI. Mean age was 82 ± 4 years, and 25 patients (55.6 %) were female. Mean aortic annulus diameter was 20.3 ± 2.2 mm assessed by TEE on the mid-esophageal long-axis view and 23.9 ± 2.3 mm using CT (p < 0.001). There was a tendency for the TEE derived areas using the new method to be higher (p < 0.001). The TEE measurements were on average 42.33 mm(2) higher than the CT measurements without an evidence of a systematic over- or under-sizing (p = 1.00). Agreement between TEE and CT chosen valve sizes was good overall (kappa = 0.67 and weighted kappa = 0.71). For patients who turned out to have no AR, the two methods agreed in 84.6 % of patients., Conclusions: CT remanis the gold standard in sizing of the aortic valve annulus. Nevertheless, sizing of the aortic valve annulus using TEE derived area may be helpful. The impact of integration of this method in the algorithm of aortic annulus sizing on the outcome of patients undergoing TAVI should be examined in future studies.

Aims: This prospective, non-randomised, observational study conducted in Europe was designed in order to assess the long-term safety and efficacy of the Parachute device in ischaemic heart failure subjects as a result of left ventricle remodelling after anterior wall myocardial infarction., Methods and Results: One hundred subjects with New York Heart Association Class II-IV ischaemic heart failure (HF), ejection fraction (EF) between 15% and 40%, and dilated akinetic or dyskinetic anterior-apical wall without the need to be revascularised were enrolled. The primary safety endpoint was procedural- or device-related major adverse cardiac cerebral events (MACCE). The secondary safety endpoint was the composite of mortality and morbidity. Secondary efficacy endpoints included haemodynamic measurements determined by echocardiography, LV volume indices, and assessment of functional improvement measured by a standardised six-minute walk test. Of the 100 subjects enrolled, device implantation was successful in 97 (97%) subjects. The one-year rates of the primary and secondary safety endpoints were 7% and 32.3%, respectively. The secondary endpoints, LV volume reduction (p<0.0001) and six-minute walk distance improvement (p<0.01), were achieved., Conclusions: The favourable outcomes observed in this high-risk population provide reassuring safety and efficacy data to support adoption of this technology as a therapeutic option for HF subjects.

Objectives: To present results of endovascular treatment of complicated type B aortic dissection., Methods: Patients with acutely complicated type B aortic dissection extending from the left sub-clavian artery to the abdominal aorta were treated. The strategy involved the placement of a covered endoprosthesis to seal the primary entry tear and, in cases where malperfusion persisted, distal extension with uncovered stents, to enhance true lumen (TL) expansion and reperfusion of the ischaemic arterial branches originating from the TL., Results: Thirty-five patients were included. Mean age was 63.1 (37-79) years and malperfusion syndrome occurred in 71.4%. Average aortic coverage with endoprostheses was 220.6 mm (136-355 mm). In 17 cases (48.5%), distal extension with uncovered stents was necessary. Thirty-day major morbidity was 28.5%, and mortality 2.8%. At follow-up (25.6 ± 19.5 months; 4-73 months), overall mortality was 15.2%, and aortic mortality 12.1%. Additional aortic intervention was necessary in 18.2%. Although patients undergoing distal extension with bare metal stents suffered most often from preoperative malperfusion, no significant differences were noted in the 30-day and follow-up clinical results. Follow-up angio-computed tomography showed complete thrombosis of the false lumen in the proximal half of the thoracic aorta in 76.4%. Patients treated with bare stents had significantly larger aortic TL sizes, at the different abdominal aorta levels., Conclusions: In patients with complicated type B aortic dissection, tailored elongation with uncovered stents is a safe treatment of persistent malperfusion. Although the results presented are encouraging, randomized data and a longer follow-up are required to confirm benefits and complications of this strategy., (© The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Purpose: To compare semiological characteristics, precipitating stress factors and psychiatric diagnoses of girls and boys with psychogenic nonepileptic seizures (PNESs)., Methods: We retrospectively reviewed medical records of children diagnosed with PNES and who also underwent psychiatric evaluation. Sixty-two children (44 girls, 18 boys), aged 11-18 years (mean age 14.19 ± 1.96 years) were included. Diagnosis of PNES was established by any of the following: (1) observation of the seizure by a neurologist and routine EEG, (2) evaluation of amateur video records of the typical seizure and routine EEG, or (3) video-EEG monitoring. Psychiatric examinations of patients were performed using the Schedule for Affective Disorders and Schizophrenia for School Age Children-Present and Lifetime Version (KSADS-PL)., Results: Tremor was the most prevalent ictal motor sign in both girls and boys. Atonic falls and longer episodes were significantly more frequent in girls than boys. Tonic-clonic-like movements of the extremities were significantly more prevalent in boys than girls. No gender-specific differences were observed in the rates of semiological types. Academic underachievement was the most prevalent precipitating stressor for boys, and was significantly more prevalent in boys than girls. The rate of major depression was significantly higher in girls than boys. The most prominent diagnosis in boys was attention deficit/hyperactivity disorder, and this was significantly more prevalent than in girls., Conclusion: PNES in males of juvenile age may be a distinct entity from that in girls with different semiological and psychogenic correlates. Consideration of these gender-related differences may be beneficial for the early recognition and treatment of PNES., (Copyright © 2015 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.)

Unlabelled: Cell therapy is an evolving option for patients with end-stage heart failure and ongoing symptoms despite optimal medical therapy. Our goal was to evaluate retrograde bone marrow cell delivery in patients with either ischemic heart failure (IHF) or nonischemic heart failure (NIHF). This was a prospective randomized, multicenter, open-label study of the safety and feasibility of bone marrow aspirate concentrate (BMAC) infused retrograde into the coronary sinus. Sixty patients were stratified by IHF and NIHF and randomized to receive either BMAC infusion or control (standard heart failure care) in a 4:1 ratio. Accordingly, 24 subjects were randomized to the ischemic BMAC group and 6 to the ischemic control group. Similarly, 24 subjects were randomized to the nonischemic BMAC group and 6 to the nonischemic control group. All 60 patients were successfully enrolled in the study. The treatment groups received BMAC infusion without complications. The left ventricular ejection fraction in the patients receiving BMAC demonstrated significant improvement compared with baseline, from 25.1% at screening to 31.1% at 12 months (p=.007) in the NIHF group and from 26.3% to 31.1% in the IHF group (p=.035). The end-systolic diameter decreased significantly in the nonischemic BMAC group from 55.6 to 50.9 mm (p=.020). Retrograde BMAC delivery is safe. All patients receiving BMAC experienced improvements in left ventricular ejection fraction, but only those with NIHF showed improvements in left ventricular end-systolic diameter and B-type natriuretic peptide. These results provide the basis for a larger clinical trial in HF patients., Significance: This work is the first prospective randomized clinical trial using high-dose cell therapy delivered via a retrograde coronary sinus infusion in patients with heart failure. This was a multinational, multicenter study, and it is novel, translatable, and scalable. On the basis of this trial and the safety of retrograde coronary sinus infusion, there are three other trials under way using this route of delivery., (©AlphaMed Press.)

Secondary mitral regurgitation (MR) has a complex pathophysiology that includes global or segmental left ventricular (LV) motion abnormalities (of non-ischaemic or ischaemic origin) leading to impaired leaflet coaptation of a normally structured mitral valve (MV). In this context, the LV functional and geometrical changes result in MV leaflet tethering, MV annulus flattening and the decrement of systolic MV closing forces. In light of its complexity, management of secondary MR remains a challenge. In fact, a long-lasting successful treatment using a single medical device and/or intervention that addresses solely the MV target cannot, at least at the present time, be proposed.