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Since its introduction in 2003, Abbott's MitraClip (MC) has become the most established catheter-based treatment for mitral regurgitation (MR). Recent approval of Edwards Lifescience's PASCAL device has extended the field of TEER. The aim of this retrospective multicenter study was to compare the PASCAL and MC regarding procedural results and short- and long-term outcomes after mitral valve transcatheter edge-to-edge repair (TEER). Data from 3 high-volume centers were analyzed. The primary endpoint was residual MR at discharge. Secondary endpoints were technical success, MR reduction, and 30-day mortality. After 1 year, all-cause mortality and residual MR were reported. A total of 412 patients (216 MC, 196 PASCAL) treated between 2018 and 2020 were included. A total of 184 patients (92 in each treatment group) remained after propensity score matching. The rate of baseline MR ≥3 was 98.9% in both groups (P = 1.00). Both TEER systems achieved equally high technical success rates (97.8%; P = 1.00), resulting in residual MR ≤1 in 69.6% vs 77.1% of patients (P = 0.24) and MR reduction by ≥2 grades in 83.7% vs 92.4% of patients (P = 0.13) using the MC and PASCAL, respectively. Thirty-day mortality was 1.1% in both cohorts (P = 0.98), and 1-year follow-up showed similar MR reductions (residual MR ≤1, 78.0% with MC vs 82.3% with PASCAL; P = 0.70) and comparable all-cause mortality (14.1% with MC vs 6.5% with PASCAL; P = 0.14). In multivariate regression analysis, Society of Thoracic Surgeons score independently correlated with an optimal result (MR ≤1), while device choice did not show a significant impact. In this retrospective multicenter study, the established MC and the novel PASCAL mitral valve TEER systems were safe and offered excellent performance with comparable short- and long-term outcomes. [Display omitted] [ABSTRACT FROM AUTHOR]

Transcatheter treatment techniques for tricuspid regurgitation (TR) have evolved in recent years, with leaflet repair being the most commonly used, but thus far evidence on the PASCAL and PASCAL Ace system is based mainly on compassionate use data. This is the first report on commercial use in a multicenter study with a large patient cohort investigating the safety and efficacy of the PASCAL and PASCAL Ace system in the treatment of TR. In a retrospective, multicenter, observational setting, data from all consecutive patients undergoing leaflet repair for TR at 8 centers was collected, including a centralized analysis of echocardiographic data. A total of 235 high-risk patients (mean age 78 ± 8 years, 49% women, mean Society of Thoracic Surgeons Predicted Risk of Mortality score 8.6% ± 6.8%) were included. TR was functional in 87% of patients and graded severe or higher in 91%. TR was successfully reduced to moderate or less in 78% of patients (P < 0.001). Procedural success was 78% (n = 153). At the latest available follow-up (median 173 days), TR reduction was sustained (78% with TR moderate or less; P < 0.001), and echocardiography showed indications of right ventricular remodeling (mean right ventricular end-diastolic diameter 56 ± 9 mm vs 53 ± 9 mm; P < 0.001). Patients' symptoms diminished significantly (63% were in New York Heart Association functional class I or II at follow-up; P < 0.001). In a device-specific analysis, the PASCAL and PASCAL Ace showed no difference in TR reduction (postprocedural TR moderate or less in 77% vs 78%; P = 0.82). In early clinical experience, the PASCAL (Ace) leaflet repair system has high technical and procedural success rates with efficient TR reduction and significant clinical and echocardiographic improvement at follow-up. [Display omitted] [ABSTRACT FROM AUTHOR]

Background: The phenomenon of declining numbers of patients presenting with myocardial infarction was reported from the beginning of the COVID-19 pandemic onward. It was thought that measures introduced to stem the pandemic, such as the lockdown, contributed to this development. However, the data on hospital admissions, delay times, and mortality are not consistent. Methods: Our systematic literature review and meta-analysis embraced studies reporting the number of hospital admissions of patients with ST-segment elevation myocardial infarction (STEMI) and/or non-ST-segment elevation myocardial infarction (NSTEMI) during lockdown episodes. We also collected data on patient- and system-related delay times and on mortality. Results: Data from 27 studies on a total of 81 163 patients were included in our meta-analysis. We found that the number of hospital admissions of patients with myocardial infarction was significantly lower during the lockdown than before the pandemic (incidence rate ratio [IRR] = 0.516 [0.403; 0.660], I² = 98%). This was true both for patients with STEMI (IRR = 0.620 [0.514; 0.746], I² = 96%) and for patients with NSTEMI (IRR = 0.454 [0.354; 0.584], I² = 96%). However, we found no significant differ- ence in the time from hospital admission to cardiac catheterization, or in mortality, in relation to the time from symptom onset to first medical contact. Conclusion: In this study, we have shown that the lockdown due to COVID-19 was associated with a marked decline in the number of hospital admissions of patients with myocardial infarction. As no significant effect on delay times or mortality was observed, it seems that timely medical care continued to be delivered. [ABSTRACT FROM AUTHOR]

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 ) [ABSTRACT FROM AUTHOR]

Background: Drug-coated balloons (DCBs) are an established treatment strategy for coronary artery disease. Randomized data on the application of DCBs in patients with an acute coronary syndrome (ACS) are limited. We evaluated the impact of clinical presentation (ACS versus chronic coronary syndrome) on clinical outcomes in patients undergoing DCB or drug-eluting stent (DES) treatment in a prespecified analysis of the BASKET-SMALL 2 trial (Basel Kosten Effektivitats Trial-Drug-Coated Balloons Versus Drug-Eluting Stents in Small Vessel Interventions). Methods: BASKET-SMALL 2 randomized 758 patients with small vessel coronary artery disease to DCB or DES treatment and followed them for 3 years regarding major adverse cardiac events (cardiac death, nonfatal myocardial infarction, and target vessel revascularization). Results: Among 758 patients, 214 patients (28.2%) presented with an ACS (15 patients [7%], ST-segment-elevation myocardial infarction; 109 patients [50.9%], non-ST-segment-elevation myocardial infarction; 90 patients [42.1%], unstable angina pectoris). At 1-year follow-up, there was no significant difference in the incidence of the primary end point by randomized treatment in patients with ACS (hazard ratio, 0.50 [95% CI, 0.19-1.26] for DCB versus DES) or chronic coronary syndrome (hazard ratio, 1.29 [95% CI, 0.67-2.47] for DCB versus DES). There was no significant interaction between clinical presentation and treatment effect (P for interaction, 0.088). For cardiac death (P for interaction, 0.049) and nonfatal myocardial infarction (P for interaction, 0.010), a significant interaction between clinical presentation and treatment was seen at 1 year with lower rates of these secondary end points in patients with ACS treated by DCB. At 3 years, there were similar major adverse cardiac event rates throughout groups without significant interaction between clinical presentation and treatment (P for interaction, 0.301). All-cause mortality was higher in ACS compared with chronic coronary syndrome; however, there was no difference between DCB and DES irrespective of clinical presentation. Conclusions: In this subgroup analysis of the BASKET-SMALL 2 trial, there was no interaction between indication for percutaneous coronary intervention (acute versus chronic coronary syndrome) and treatment effect of DCB versus DES in patients with small vessel coronary artery disease. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01574534. * A drug-coated balloon treatment strategy compared with drug-eluting stent implantation resulted in similar major adverse cardiac event rates at 1- and 3-year follow-up in patients presenting with acute coronary syndromes. * Major adverse cardiac event rates in drug-coated balloon-treated patients with an acute coronary syndrome were low and similar to the rates of those receiving drug-coated balloon treatment for chronic coronary syndrome. * The drug-coated balloon treatment strategy has evolved for patients presenting with in-stent restenosis, de novo small vessel coronary artery disease, and for patients at high bleeding risk. * Our results expand the knowledge of this approach to patients presenting with an acute coronary syndrome supporting the concept of leaving nothing behind without compromising safety. [ABSTRACT FROM AUTHOR]