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Bad Nauheim, Germany

Hoffmann R.,RWTH Aachen | Mollmann H.,Kerckhoff Klinik | Lotfi S.,RWTH Aachen
Catheterization and Cardiovascular Interventions | Year: 2013

Treatment options for re-stenotic aortic valve prosthesis implanted by transcatheter technique have not been evaluated systematically. We describe the case of a 75-year-old dialysis patient who was treated by transcatheter aortic valve implantation 3.5 years ago and now presented with severe stenosis of the percutaneous heart valve. The patient was initially treated with a trans-apical implantation of an Edwards Sapien 26 mm balloon expandable valve. The patient remained asymptomatic for 3 years when he presented with increasing shortness of breath and significant calcification of the valve prosthesis on transesophageal echocardiography. Valve-in-valve percutaneous heart valve implantation using a 26-mm CoreValve prosthesis was performed under local anesthesia. The prosthesis was implanted without prior valvuloplasty. Pacing with a frequency of 140/min was applied during placement of the valve prosthesis. Positioning was done with great care using only fluoroscopic guidance with the aim to have the ventricular strut end of the CoreValve prosthesis 5 mm higher than the ventricular strut end of the Edwards Sapien prosthesis. After placement of the CoreValve prosthesis within the Edwards Sapien valve additional valvuloplasty with rapid pacing was performed in order to further expand the CoreValve prosthesis. The final result was associated with a remaining mean gradient of 5 mm Hg and no aortic regurgitation. In conclusion, implantation of a CoreValve prosthesis for treatment of a restenotic Edwards Sapien prosthesis is feasible and is associated with a good functional result. Copyright © 2012 Wiley Periodicals, Inc.

Seeburger J.,University of Leipzig | Rinaldi M.,University of Turin | Nielsen S.L.,University of Aarhus | Salizzoni S.,University of Turin | And 6 more authors.
Journal of the American College of Cardiology | Year: 2014

Objectives The goal of this study was to evaluate the safety and performance of the NeoChord DS1000 system (NeoChord, Inc., Minneapolis, Minnesota). Background There is an increasing interest in transcatheter mitral valve (MV) treatment. The NeoChord DS 1000 system enables off-pump beating heart transapical MV repair with implantation of artificial neo-chordae. Methods Patients with severe mitral regurgitation (MR) due to isolated posterior prolapse were included in this TACT (Transapical Artificial Chordae Tendinae) trial. All patients were scheduled for off-pump transapical implantation of neo-chordae. Results Thirty patients at 7 centers were enrolled. Major adverse events included 1 death due to post-cardiotomy syndrome and concomitant sepsis and 1 minor stroke with the patient fully recovered at the 30-day follow-up visit. Additional patients experienced procedural major adverse events related to a reoperation or conversion to standard of care. Acute procedural success (placement of at least 1 neo-chord and reduction of MR from 3+ or 4+ to ≤2+) was achieved in 26 patients (86.7%). In 4 patients neo-chordae were not placed for technical and/or patient-specific reasons. These patients underwent intraoperative (3 patients) or post-operative (1 patient) standard MV repair. At 30 days, 17 patients maintained an MR grade ≤2+. Four patients who developed recurrent MR were successfully treated with open MV repair during 30-day follow-up. Results improved with experience: durable reduction in MR to ≤2+ at 30 days was achieved in 5 (33.3%) of the first 15 patients and 12 (85.7%) of the last 14 patients. Conclusions Off-pump transapical implantation of artificial chordae to correct MR is technically safe and feasible; however, it yields further potential for improvement of efficacy and durability. (Safety and Performance Study of the NeoChord Device [TACT]; NCT01777815).

Singh J.P.,Harvard University | Klein H.U.,University of Rochester | Huang D.T.,University of Rochester | Reek S.,University Hospital | And 8 more authors.
Circulation | Year: 2011

Background-: An important determinant of successful cardiac resynchronization therapy for heart failure is the position of the left ventricular (LV) pacing lead. The aim of this study was to analyze the impact of the LV lead position on outcome in patients randomized to cardiac resynchronization-defibrillation in the Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy (MADIT-CRT) study. Methods and results-: The location of the LV lead was assessed by means of coronary venograms and chest X-rays recorded at the time of device implantation. The LV lead location was classified along the short axis into an anterior, lateral, or posterior position and along the long axis into a basal, midventricular, or apical region. The primary end point of MADIT-CRT was heart failure (HF) hospitalization or death, whichever came first. The LV lead position was assessed in 799 patients, (55% patients 65 years of age, 26% female, 10% LV ejection fraction ≤25%, 55% ischemic cardiomyopathy, and 71% left bundle-branch block) with a follow-up of 29±11 months. The extent of cardiac resynchronization therapy benefit was similar for leads in the anterior, lateral, or posterior position (P=0.652). The apical lead location compared with leads located in the nonapical position (basal or midventricular region) was associated with a significantly increased risk for heart failure/death (hazard ratio=1.72; 95% confidence interval, 1.09 to 2.71; P=0.019) after adjustment for the clinical covariates. The apical lead position was also associated with an increased risk for death (hazard ratio=2.91; 95% confidence interval, 1.42 to 5.97; P=0.004). Conclusion-: LV leads positioned in the apical region were associated with an unfavorable outcome, suggesting that this lead location should be avoided in cardiac resynchronization therapy. © 2011 American Heart Association, Inc.

Schymik G.,Medical Clinic IV | Lefevre T.,Institute Hospitalier Jacques Cartier | Bartorelli A.L.,University of Milan | Rubino P.,Casa di Cura Montevergine | And 8 more authors.
JACC: Cardiovascular Interventions | Year: 2015

Objectives The SOURCE XT Registry (Edwards SAPIEN XT Aortic Bioprosthesis Multi-Region Outcome Registry) assessed the use and clinical outcomes with the SAPIEN XT (Edwards Lifesciences, Irvine, California) valve in the real-world setting. Background Transcatheter aortic valve replacement is an established treatment for high-risk/inoperable patients with severe aortic stenosis. The SAPIEN XT is a balloon-expandable valve with enhanced features allowing delivery via a lower profile sheath. Methods The SOURCE XT Registry is a prospective, multicenter, post-approval study. Data from 2,688 patients at 99 sites were analyzed. The main outcome measures were all-cause mortality, stroke, major vascular complications, bleeding, and pacemaker implantations at 30-days and 1 year post-procedure. Results The mean age was 81.4 ± 6.6 years, 42.3% were male, and the mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 20.4 ± 12.4%. Patients had a high burden of coronary disease (44.2%), diabetes (29.4%), renal insufficiency (28.9%), atrial fibrillation (25.6%), and peripheral vascular disease (21.2%). Survival was 93.7% at 30 days and 80.6% at 1 year. At 30-day follow-up, the stroke rate was 3.6%, the rate of major vascular complications was 6.5%, the rate of life-threatening bleeding was 5.5%, the rate of new pacemakers was 9.5%, and the rate of moderate/severe paravalvular leak was 5.5%. Multivariable analysis identified nontransfemoral approach (hazard ratio [HR]: 1.84; p < 0.0001), renal insufficiency (HR: 1.53; p < 0.0001), liver disease (HR: 1.67; p = 0.0453), moderate/severe tricuspid regurgitation (HR: 1.47; p = 0.0019), porcelain aorta (HR: 1.47; p = 0.0352), and atrial fibrillation (HR: 1.41; p = 0.0014), with the highest HRs for 1-year mortality. Major vascular complications and major/life-threatening bleeding were the most frequently seen complications associated with a significant increase in 1-year mortality. Conclusions The SOURCE XT Registry demonstrated appropriate use of the SAPIEN XT THV in the first year post-commercialization in Europe. The safety profile is sustained, and clinical benefits have been established in the real-world setting. (SOURCE XT Registry; NCT01238497). © 2015 American College of Cardiology Foundation.

Lorchner H.,Max Planck Institute for Heart and Lung Research | Poling J.,Max Planck Institute for Heart and Lung Research | Gajawada P.,Max Planck Institute for Heart and Lung Research | Hou Y.,Max Planck Institute for Heart and Lung Research | And 9 more authors.
Nature Medicine | Year: 2015

Cardiac healing after myocardial ischemia depends on the recruitment and local expansion of myeloid cells, particularly macrophages. Here we identify Reg3β as an essential regulator of macrophage trafficking to the damaged heart. Using mass spectrometry-based secretome analysis, we found that dedifferentiating cardiomyocytes release Reg3β in response to the cytokine OSM, which signals through Jak1 and Stat3. Loss of Reg3β led to a large decrease in the number of macrophages in the ischemic heart, accompanied by increased ventricular dilatation and insufficient removal of neutrophils. This defect in neutrophil removal in turn caused enhanced matrix degradation, delayed collagen deposition and increased susceptibility to cardiac rupture. Our data indicate that OSM, acting through distinct intracellular pathways, regulates both cardiomyocyte dedifferentiation and cardiomyocyte-dependent regulation of macrophage trafficking. Release of OSM from infiltrating neutrophils and macrophages initiates a positive feedback loop in which OSM-induced production of Reg3β in cardiomyocytes attracts additional OSM-secreting macrophages. The activity of the feedback loop controls the degree of macrophage accumulation in the heart, which is instrumental in myocardial healing.

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