Matthias Waliszewski

Bio: Matthias Waliszewski is an academic researcher from B. Braun Melsungen. The author has contributed to research in topics: Stent & Angioplasty. The author has an hindex of 11, co-authored 53 publications receiving 800 citations. Previous affiliations of Matthias Waliszewski include Charité.

Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty.

Abstract: This study investigated p aclitaxel-induced luminal changes following drug-coated balloon (DCB) angioplasty to treat coronary de novo lesions without additional stenting. DCB-mediated local drug delivery reduces late lumen loss in de novo coronary artery lesions. We performed a retrospective clinical assessment based on a pre-specified quantitative coronary angiography (QCA) protocol. QCA was performed for each centre to assess the primary endpoint late lumen changes, i.e. the difference between in-lesion minimal lumen diameter (MLD) at the routine angiographic follow-up as compared to post-procedural in-lesion MLDs. These MLD changes were compared to corresponding reference vessel diameter changes as an intra-patient control. We evaluated 58 consecutive native coronary artery lesions directly after DCB angioplasty and at a routine target follow-up angiography of 4 months by QCA. Target lesion MLD increased significantly within the 4.1 ± 2.1 month observation period (1.75 ± 0.55 vs. 1.91 ± 0.55 mm, p < 0.001, diameter stenosis 33.8 ± 12.3 vs. 26.9 ± 13.8 %, p < 0.001), while there were no changes in non-target reference vessel diameters (2.33 ± 0.60 vs. 2.34 ± 0.61 mm, p = ns). A total of 69 % of patients showed luminal enlargement whereas 29 % had minor luminal loss. Local application of paclitaxel by DCB angioplasty to native coronary arteries after pre-dilatation without major dissection and recoil leads to late lumen increase.

Prospective ‘real world’ registry for the use of the ‘PCB only’ strategy in small vessel de novo lesions

Abstract: Background This prospective registry assessed the safety and efficacy of paclitaxel coated balloon (PCB) angioplasty for small vessel coronary artery disease in Europe and Asia with the intention to treat lesions without additional stenting. The use of PCBs in small vessels seems to be associated with favourable outcomes; however, prospective data for the use of PCBs without stenting are limited. Methods The SeQuent Please Small Vessel ‘PCB only’ Registry was an international, prospective, multicentre registry enrolling patients with de novo lesions of small reference diameters (≥2.0 mm, ≤2.75 mm). The primary end point was clinically driven target lesion revascularisation (TLR) at 9 months. Secondary end points were acute technical success, in-hospital outcomes, 9-month major adverse cardiac events (MACE) (death, myocardial infarction, or TLR), and the occurrence of definite lesion and vessel thrombosis. Results A total of 479 patients (66.1±10.9 years, 36.7% diabetics) were enrolled, 105 (23.5%) with an acute coronary syndrome, 41 (9.2%) with ST elevation myocardial infarction (STEMI), and 60 (14.8%) with non-STEMI. The initial procedural success rate was 99.0%; 27 patients (6%) needed additional bare metal stent implantation. TLR at 9.4±1.7 months occurred in 14 patients (3.6%), while three patients (0.6%) had vessel thrombosis in non-target lesions. There was no cardiac death or coronary artery bypass graft surgery. Conclusions To date, this is the largest prospective study with PCBs in small vessel de novo lesions in unselected patients. Rates of TLR and MACE were low, suggesting the use of PCBs may be an attractive alternative treatment option to drug eluting stents in small vessels.

Long-Term Outcomes After Treatment With a Paclitaxel-Coated Balloon Versus Balloon Angioplasty: Insights From the PEPCAD-DES Study (Treatment of Drug-eluting Stent [DES] In-Stent Restenosis With SeQuent Please Paclitaxel-Coated Percutaneous Transluminal Coronary Angioplasty [PTCA] Catheter).

Abstract: Objectives The intention this PEPCAD-DES (Treatment of Drug-eluting Stent [DES] In-Stent Restenosis With SeQuent Please Paclitaxel Eluting Percutaneous Transluminal Coronary Angioplasty [PTCA] Catheter) study update was to demonstrate the safety and efficacy of paclitaxel-coated balloon (PCB) angioplasty in patients with DES-ISR at 3 years. Background In the PEPCAD-DES trial late lumen loss and the need for repeat target lesion revascularization (TLR) was significantly reduced with PCB angioplasty compared with plain old balloon angioplasty (POBA) in patients with drug-eluting stent in-stent restenosis (DES-ISR) at 6 months. We evaluated whether the clinical benefit of reduced TLR and major adverse cardiac events (MACE) was maintained up to 3 years. Methods A total of 110 patients with DES-ISR in native coronary arteries with reference diameters ranging from 2.5 mm to 3.5 mm and lesion lengths ≤22 mm were randomized to treatment with either PCB or POBA in a multicenter, randomized, single-blind clinical study. With a 2:1 randomization, 72 patients were randomized to the PCB group and 38 patients to the POBA group. At baseline, there were lesions with at least 2 stent layers in PCB (52.8%, 38 of 72) and POBA (55.3%, 21 of 38) patients. Results At 36 months, the TLR rates were significantly lower in the PCB group compared with the POBA control group (19.4% vs. 36.8%; p = 0.046). Multiple TLRs in individual patients were more frequent in the POBA group compared with the PCB group (more than 1 TLR: POBA, 13.2%; PCB, 1.4%; p = 0.021). The 36-month MACE rate was significantly reduced in the PCB group compared with the POBA group (20.8% vs. 52.6%, log-rank p = 0.001). Conclusions PCB angioplasty was superior to POBA for the treatment of DES-ISR patients in terms of MACE and TLR for up to 36 months. There was no late catch-up phenomenon. (Treatment of Drug-eluting Stent [DES] In-Stent Restenosis With SeQuent® Please Paclitaxel Eluting Percutaneous Transluminal Coronary Angioplasty [PTCA] Catheter [PEPCAD-DES]; NCT00998439 )

Two-Year Mortality After Angioplasty of the Femoro-Popliteal Artery with Uncoated Balloons and Paclitaxel-Coated Balloons-A Pooled Analysis of Four Randomized Controlled Multicenter Trials.

Abstract: In view of a recent meta-analysis reporting increased mortality following angioplasty with paclitaxel-coated devices in peripheral arteries, we performed a patient-level 2-year mortality analysis based on pooled original data of four randomized controlled trials (THUNDER, FEMPAC, PACIFIER and CONSEQUENT). Clinical data of four randomized controlled trial were pooled to assess 2-year mortality following paclitaxel-coated balloon (PCB) angioplasty compared to angioplasty without paclitaxel (control group). A logistic regression model was applied to identify potential predictors of mortality. At two years, 13 of 185 (7.0%) patients had died in the control group and 16/184 (8.7%) in the PBC group, p = 0.55. Kaplan–Meier analysis revealed no significant difference from all-cause death at 2 years (log rank p = 0.54). Causes of death were well balanced between the groups with no pattern or trend in favour of any specific causes in the PBC group. Logistic regression revealed that treatment groups (controls or PBC) were not a predictor of 2-year mortality. The only predictor for mortality was patient age ≥ 75 years. The delivered paclitaxel doses per patient were not significantly different in patients that died and those who did not die during the 24-month follow-up (5.300 ± 4.224 μg vs. 6.248 ± 4.629 μg, p = 0.433). Based on original patient-level data of four pooled randomized controlled trials, we found no increase in 2-year mortality in patients treated with PCB compared to control patients treated with uncoated balloons. Causes of death were well balanced between PCB and control patients.

I and i

Abstract: There is, I think, something ethereal about i —the square root of minus one. I remember first hearing about it at school. It seemed an odd beast at that time—an intruder hovering on the edge of reality. Usually familiarity dulls this sense of the bizarre, but in the case of i it was the reverse: over the years the sense of its surreal nature intensified. It seemed that it was impossible to write mathematics that described the real world in …

2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

Abstract: Authors/Task Force Members: Franz-Josef Neumann* (ESC Chairperson) (Germany), Miguel Sousa-Uva* (EACTS Chairperson) (Portugal), Anders Ahlsson (Sweden), Fernando Alfonso (Spain), Adrian P. Banning (UK), Umberto Benedetto (UK), Robert A. Byrne (Germany), Jean-Philippe Collet (France), Volkmar Falk (Germany), Stuart J. Head (The Netherlands), Peter Jüni (Canada), Adnan Kastrati (Germany), Akos Koller (Hungary), Steen D. Kristensen (Denmark), Josef Niebauer (Austria), Dimitrios J. Richter (Greece), Petar M. Seferovi c (Serbia), Dirk Sibbing (Germany), Giulio G. Stefanini (Italy), Stephan Windecker (Switzerland), Rashmi Yadav (UK), Michael O. Zembala (Poland) Document Reviewers: William Wijns (ESC Review Co-ordinator) (Ireland), David Glineur (EACTS Review Co-ordinator) (Canada), Victor Aboyans (France), Stephan Achenbach (Germany), Stefan Agewall (Norway), Felicita Andreotti (Italy), Emanuele Barbato (Italy), Andreas Baumbach (UK), James Brophy (Canada), Héctor Bueno (Spain), Patrick A. Calvert (UK), Davide Capodanno (Italy), Piroze M. Davierwala

Risk of Death Following Application of Paclitaxel‐Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials

Abstract: Background Several randomized controlled trials (RCTs) have already shown that paclitaxel‐coated balloons and stents significantly reduce the rates of vessel restenosis and target lesion revascular...