Abstract Background The MitraClip is the worldwide established transcatheter edge-to-edge repair system with over 100,000 treated patients. The recently approved PASCAL repair system is well adopted in the field of percutaneous mitral regurgitation (MR) treatment with growing acceptance both in mitral and tricuspid valves. The aim of this retrospective multicenter study was to compare the Edwards' PASCAL System with the Abbott MitraClip System in terms of procedural results and short-term outcome. Methods We retrospectively evaluated patient data of three high volume German centers that performed percutaneous edge to edge procedures either with the MitraClip or the PASCAL repair system. Primary endpoint was the amount of MR reduction. Secondary endpoints were residual MR at discharge, technical success, device success and 30-day mortality. Results Between 2018 and 2020 a total of 412 procedures were performed in the three centers. 216 cases were performed with the MitraClip compared to 196 procedures done with the PASCAL repair system. Patients were male in 55.6% of the cases (50.5% in the MitraClip cohort compared to 61.2% in the PASCAL cohort, p=0.028), mean Logistic Euro-Score II was 4.42 (3.58 in the MitraClip and 3.23 in the PASCAL cohort, p=0.038) and reduced LVEF beyond 45% was seen in 42.6% of the cases (49.5% in the MitraClip compared to 35.3% in the PASCAL cohort, p=0.004). Severe MR at baseline was seen in 98.5% in the MitraClip cohort compared to 98.6% in the PASCAL cohort, p=0.909). Mean number of implanted devices was 1.41±0.56 in the MitraClip cohort and 1.37±0.55 in the PASCAL cohort (p=0.401). Procedures were successfully conducted with both edge-to-edge systems (device success rate 93.2% in the MitraClip cohort and 94.0% in the PASCAL cohort, p=0.775), leading to comparably good results (final MR ≤2 in 94.4% with the MitraClip compared to 95.9% with the PASCAL system, p=0.448) and very good results (final MR ≤1 in 72.6% in the MitraClip compared to 79.5% in the PASCAL cohort, p=0.102). After propensity score matching for adjustment of major differences among the two treatment strategies (including age, gender, MR etiology, EROA, Severe MR (III and IV), reduced LVEF and Mitral Valve orifice area) the achieved mean MR reduction remains comparable (2.29±0.82 with the MitraClip compared to 2.46±0.82 with the PASCAL system, p=0.191). In multivariate regression analysis STS Score independently correlates with a very good final result while device choice did not show a significant impact in this cohort. Conclusion In this retrospective multicenter study both the MitraClip and PASCAL system performed excellent with comparable procedural success rates. Achieved final average reduction of MR Grade was 2.29±0.82 with the MitraClip and 2.46±0.82 with the PASCAL system. Funding Acknowledgement Type of funding sources: None.
Background: Atrial fibrillation is common in patients with mitral regurgitation (MR) and has a negative impact on the clinical outcome of patients with valvular heart disease. We aimed to evaluate the impact of pre-procedural atrial fibrillation on the long-term clinical outcomes of patients with MR undergoing transcatheter mitral valve repair by MitraClip implantation. Methods: We analysed 355 consecutive patients with and without atrial fibrillation with symptomatic, severe MR and inoperability or high surgical risk undergoing MitraClip implantation in a three-year follow-up. Results: In patients with pre-procedural atrial fibrillation undergoing MitraClip implantation, we found advanced age, higher baseline NT-pro-BNP levels, increased left atrial diameter, and higher rate of severe tricuspid regurgitation, compared to patients with sinus rhythm. In the three-year follow-up after MitraClip implantation, mortality and major adverse cardiovascular and cerebral events (MACCE) occur significantly more often in patients with atrial fibrillation, compared to patients without atrial fibrillation. Multivariate regression analysis confirmed atrial fibrillation (hazard ratio 2.39, 95%-confidence interval 1.06⁻5.41, p = 0.036) as an independent predictor for three-year-mortality after MitraClip implantation. Conclusions: Atrial fibrillation is an independent predictor for long-term mortality after MitraClip implantation. We demonstrate the association of atrial fibrillation with mortality and MACCE in the long-term follow-up of patients undergoing MitraClip implantation.
The aim of this study was to evaluate the accuracy of 1-day stress-rest technetium-99m tetrofosmin myocardial tomography in the identification of patients with coronary artery disease (CAD), and in the detection of the individual occluded coronary vessels. A total of 42 patients with suspected CAD were studied. Significant coronary narrowing (> or = 50% luminal stenosis) was detected by angiography in 22 patients. All patients received two i.v. injections of 99mTc tetrofosmin, one at peak exercises (370 MBq) and the other (740 MBq) at rest 3 h after exercise (images 15-30 min after injections for both studies). At visual analysis, all patients with CAD (> or = 50% luminal stenosis) (n-22) had an abnormal 99mTc tetrofosmin tomogram. Nine out of 20 patients without significant coronary narrowing (but with tortuosis, atheromathosis, with microvascular diseases) showed abnormal findings. Overall sensitivity, specificity and diagnostic accuracy in the identification of CAD was 100%, 55%, and 79%, respectively. Sensitivity, specificity and diagnostic accuracy in the identification of individuals with occluded coronary vessels were 100%, 76% and 85%, respectively. The results of this study demonstrate that 1-day exercise-rest 99mTc tetrofosmin single-photon emission tomographic imaging (SPET) is a suitable and accurate technique to identify patients with CAD and for detection of individual occluded coronary vessels.
Abstract Aims Prevalence of mitral regurgitation (MR) and comorbidity burden rise with age. Mitral valve transcatheter edge‐to‐edge repair (M‐TEER) is increasingly performed in elderly patients, but only limited data are available for this specific subgroup. In this study, outcomes of octogenarians and nonagenarians undergoing M‐TEER were analysed using a large real‐world dataset. Methods This retrospective study included consecutive patients undergoing M‐TEER at the Ulm University Heart Center between January 2010 and December 2021. The cohort was divided into an elderly group and a younger group based on the cohorts' median age. Group differences regarding 1 and 3 year mortality and heart failure hospitalization rates were assessed using Kaplan–Meier survival analysis and Cox proportional hazard models. Results A total of 1118 patients [median age 79 (inter‐quartile range 74–83) years; 42% female] were included and divided into 513 elderly (≥80 years) and 605 younger (<80 years) patients. Primary MR was more frequent in the elderly group (56% vs. 27%, P < 0.001). Pre‐procedural and post‐procedural MR grades were comparable between groups (pre‐procedural MR grade 4: 69% in the elderly group vs. 71% in the younger group, P = 0.67; post‐procedural MR grade 1: 60% in the elderly group vs. 58% in the younger group, P = 0.77) as well as in‐hospital mortality rates (0.2% vs. 0.3%, P = 0.66). Three‐year heart failure hospitalization rates did not differ significantly between both groups (30.7% in the older age cohort vs. 36.0% in the younger cohort, P = 0.191). While 1 year all‐cause mortality rates were comparable (18% vs. 16.4%, P = 0.577), 3 year all‐cause mortality was significantly higher in the elderly [43.1% vs. 33.0%; hazard ratio (HR) 1.29 (95% confidence interval 1.02–1.65), P = 0.035]. Pre‐procedural N‐terminal pro‐brain natriuretic peptide (NT‐proBNP) ≥3402 pg/mL [HR 2.29 (95% CI 1.34–3.90), P = 0.002], pre‐interventional MR grade [HR 1.79 (95% CI 1.01–3.17), P = 0.045] and European System for Cardiac Operative Risk Evaluation (EuroSCORE) II [HR 1.06 (95% CI 1.03–1.08), P < 0.001] were identified as independent predictors of 3 year mortality in the elderly. Conclusions M‐TEER displays a safe and effective treatment option for elderly patients with symptomatic MR, offering symptom relief and comparable 1 year outcomes to younger patients. Elderly patients with elevated EuroSCORE II and advanced heart failure might benefit from additional care to further reduce 3 year mortality.
CENTURY II is a prospective, multicentre, randomised, single-blind trial comparing the bioresorbable polymer sirolimus-eluting Ultimaster® stent (BP-SES) with the permanent polymer everolimus-eluting XIENCE stent (PP-EES). Here we present a pre-specified analysis of safety and efficacy outcomes in a subgroup of patients with small vessel coronary artery disease.CENTURY II included 525 patients with lesions of reference diameter ≤2.5 mm. Treatment was randomly assigned: 277 patients received BP-SES (399 lesions) and 248 patients received PP-EES (377 lesions). The primary outcome was target lesion failure (TLF), which is a composite of cardiac death, target vessel-related myocardial infarction (MI) and target lesion revascularisation (TLR). There was no significant difference between treatment groups in baseline or procedural data. Mean pre-procedural reference diameter was similar (BP-SES 2.30±0.40 mm, PP-EES 2.31±0.42 mm, p=0.59). Stented length was 24.0±11.7 mm for BP-SES and 23.5±11.5 mm for PP-EES (p=0.45). At 12 months, there was no significant difference between the BP-SES and PP-EES groups in TLF (6.9% vs. 7.7%; p=0.72), cardiac death (1.1% vs. 1.2%; p=0.90), target vessel MI (1.8% vs. 3.2%; p=0.30), TLR (4.0% vs. 5.7%; p=0.37), or definite or probable stent thrombosis (0.7% vs. 1.2%; p=0.57).In the large-scale, randomised CENTURY II trial, use of BP-SES and PP-EES for the treatment of small vessel coronary artery disease resulted in similar outcomes at 12 months.
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.
Percutaneous coronary intervention with stent implantation is limited by the occurrence of re-stenosis and the risk of stent thromboses.
Objective
To define the impact of paclitaxel-coated balloon angioplasty plus endothelial progenitor cell capturing (EPC) stent implantation in de novo coronary artery disease. This combination may reduce neointimal proliferation within the EPC stent and address the risk of stent thrombosis by facilitating rapid endothelialisation.
Methods
In this prospective single-blind multicentre randomised trial, 120 patients with a de novo lesion in a native coronary artery were randomly assigned to undergo treatment with paclitaxel-coated balloon plus EPC stent or EPC stent alone. Dual antiplatelet therapy was prescribed for 3 months. Angiographic follow-up was scheduled at 6 months. The primary endpoint was in-stent late lumen loss. The secondary clinical endpoint was a composite of death from a cardiac cause, myocardial infarction attributed to the target vessel or target lesion revascularisation.
Results
There was no difference in patient baseline characteristics or procedural results. The angiographic follow-up rate was 96%. Treatment with paclitaxel-coated balloon plus EPC stent was superior to EPC stent alone, with an in-stent late loss of 0.34±0.45 mm versus 0.88±0.48 mm (p<0.001). The re-stenosis rate was reduced from 23.2% to 5.1% (p=0.006) and the clinical endpoint was reduced from 17.2% to 4.8% (p=0.039). There was no definite or probable stent thrombosis.
Conclusions
Paclitaxel-coated balloon plus EPC stent implantation is superior to EPC stent implantation alone for treatment of de novo coronary artery disease.
The third generation drug eluting Orsiro stent had shown already promising results in non-complex lesions.We evaluated angiographic and 24 month clinical results of the sirolimus eluting Orsiro stents (O-SES) after recanalization of coronary chronic total occlusions (CTO). Results were compared with the zotarolimus eluting Resolute Integrity (R-ZES).In a prospective series 57 patients were treated with a R-ZES followed by 74 patients treated with a O-SES stent. Angiographic follow up after 9 months and clinical follow-up after 12 and 24 months was performed.In-stent late lumen loss was 0.24±0.53 mm for the O-SES compared with 0.59±0.72 (P=0.01) for R-ZES. Rates for TLR were similar (O-SES 10.0% versus R-ZES 11.1%, P=0.84). There was no definite stent thrombosis.The O-SES resulted in a significant lower late lumen loss but with similar clinical results up to 24 month compared to the R-ZES after treatment of CTO lesions.
'%3e%3cg id='b'%3e%3cpath id='a' d='M0-3v3h1.5z' transform='rotate(18 0 -3)'/%3e%3cuse xlink:href='%23a' transform='scale(-1 1)'/%3e%3c/g%3e%3cuse xlink:href='%23b' transform='rotate(72)'/%3e%3cuse xlink:href='%23b' transform='rotate(144)'/%3e%3cuse xlink:href='%23b' transform='rotate(216)'/%3e%3cuse xlink:href='%23b' transform='rotate(288)'/%3e%3c/g%3e%3cpath d='M0 12h18v12H0z'/%3e%3c/g%3e%3cg fill='%23d21034'%3e%3cpath d='M18 0h18v12H18z'/%3e%3cuse xlink:href='%23c' x='18' y='12'/%3e%3c/g%3e%3c/svg%3e)