Percutaneous Mitral Valve Edge-to-Edge Repair Nickenig, Georg, MD, PhD; Estevez-Loureiro, Rodrigo, MD, PhD; Franzen, Olaf, MD ...
Journal of the American College of Cardiology,
09/2014, Letnik:
64, Številka:
9
Journal Article
Recenzirano
Odprti dostop
Abstract Background The use of transcatheter mitral valve repair (TMVR) has gained widespread acceptance in Europe, but data on immediate success, safety, and long-term echocardiographic follow-up in ...real-world patients are still limited. Objectives The aim of this multinational registry is to present a real-world overview of TMVR use in Europe. Methods The Transcatheter Valve Treatment Sentinel Pilot Registry is a prospective, independent, consecutive collection of individual patient data. Results A total of 628 patients (mean age 74.2 ± 9.7 years, 63.1% men) underwent TMVR between January 2011 and December 2012 in 25 centers in 8 European countries. The prevalent pathogenesis was functional mitral regurgitation (FMR) (n = 452 72.0%). The majority of patients (85.5%) were highly symptomatic (New York Heart Association functional class III or higher), with a high logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) (20.4 ± 16.7%). Acute procedural success was high (95.4%) and similar in FMR and degenerative mitral regurgitation (p = 0.662). One clip was implanted in 61.4% of patients. In-hospital mortality was low (2.9%), without significant differences between groups. The estimated 1-year mortality was 15.3%, which was similar for FMR and degenerative mitral regurgitation. The estimated 1-year rate of rehospitalization because of heart failure was 22.8%, significantly higher in the FMR group (25.8% vs. 12.0%, plog-rank = 0.009). Paired echocardiographic data from the 1-year follow-up, available for 368 consecutive patients in 15 centers, showed a persistent reduction in the degree of mitral regurgitation at 1 year (6.0% of patients with severe mitral regurgitation). Conclusions This independent, contemporary registry shows that TMVR is associated with high immediate success, low complication rates, and sustained 1-year reduction of the severity of mitral regurgitation and improvement of clinical symptoms.
The paradigm of a shorter pain-to-balloon time decreasing extent of infarct size may be not completely true in transferred patients. This study evaluated the influence of pain-to-balloon time on ...infarct size as assessed by delayed enhancement magnetic resonance imaging in patients transferred from a peripheral hospital to a tertiary center for primary coronary angioplasty (percutaneous coronary intervention PCI). Sixty patients (40 men, 64 ± 3 years of age) with first acute myocardial infarction were treated within <168, 168 to 222, 223 to 300, and >300 minutes. A presentation score system including clinical, laboratory, and echocardiographic data was used to classify severity of presentation at admission. Magnetic resonance imaging was performed 6 ± 3 days after PCI. Group 1 had a higher presentation score than did group 2 (p <0.02) and group 3 (p <0.02). Group 1 had a significantly longer delayed enhancement than did group 2 (p <0.002) and group 3 (p <0.03). In conclusion we found that patients with worse presentation are transferred sooner for primary PCI. This approach in these patients does not decrease infarct size likely because of unavoidable delay to reperfusion. This finding suggests a different therapeutic strategy in these patients.
Objectives The aim of this study was to evaluate whether thrombectomy during primary percutaneous coronary intervention (pPCI) in patients with high thrombus burden improves myocardial reperfusion ...and reduces infarct size. Background Thrombectomy aims at reducing distal thrombotic embolization during pPCI, improving myocardial reperfusion and clinical outcome. Methods We randomized 208 patients with high thrombus burden in a 1:1 ratio to either pPCI with thrombectomy (Group T) or standard pPCI (Group S). Thrombectomy was performed with either rheolytic or manual aspiration catheters. Three-month magnetic resonance imaging was performed to assess infarct size and transmurality and microvascular obstruction (MVO). The primary endpoints were ST-segment elevation resolution (STR) >70% at 60 min and 3-month infarct size. Results The baseline profile was similar between groups, except for a higher rate of initial Thrombolysis In Myocardial Infarction flow grade 3 in Group S (p = 0.002). Group T showed a significantly higher rate of STR (57.4% vs. 37.3%; p = 0.004) and of final myocardial blush 3 (68.3% vs. 52.9%; p = 0.03). Group T and Group S did not differ with regard to infarct size (20.4 ± 10.5% vs. 19.3 ± 10.6%; p = 0.54) and transmurality (11.9 ± 12.0% vs. 11.6 ± 12.7%; p = 0.92), but Group T showed significantly less MVO (11.4% vs. 26.7%; p = 0.02) and a higher prevalence of inhomogeneous scar (p < 0.0001). One-year freedom from major adverse cardiac events was similar between groups. Conclusions Thrombectomy as an adjunct to pPCI in patients with high thrombus load yielded better post-procedural STR and reduced MVO at 3 months but was not associated with a reduction in infarct size and transmurality. Thromboaspiration in Patients With High Thrombotic Burden Undergoing Primary Percutaneous (Coronary Intervention; NCT01472718 )
Objectives This study sought to determine the risk versus benefit ratio of an early aggressive (EA) approach in elderly patients with non–ST-segment elevation acute coronary syndromes (NSTEACS). ...Background Elderly patients have been scarcely represented in trials comparing treatment strategies in NSTEACS. Methods A total of 313 patients ≥75 years of age (mean 82 years) with NSTEACS within 48 h from qualifying symptoms were randomly allocated to an EA strategy (coronary angiography and, when indicated, revascularization within 72 h) or an initially conservative (IC) strategy (angiography and revascularization only for recurrent ischemia). The primary endpoint was the composite of death, myocardial infarction, disabling stroke, and repeat hospital stay for cardiovascular causes or severe bleeding within 1 year. Results During admission, 88% of the patients in the EA group underwent angiography (55% revascularization), compared with 29% (23% revascularization) in the IC group. The primary outcome occurred in 43 patients (27.9%) in the EA group and 55 (34.6%) in the IC group (hazard ratio HR: 0.80; 95% confidence interval CI: 0.53 to 1.19; p = 0.26). The rates of mortality (HR: 0.87; 95% CI: 0.49 to 1.56), myocardial infarction (HR: 0.67; 95% CI: 0.33 to 1.36), and repeat hospital stay (HR: 0.81; 95% CI: 0.45 to 1.46) did not differ between groups. The primary endpoint was significantly reduced in patients with elevated troponin on admission (HR: 0.43; 95% CI: 0.23 to 0.80), but not in those with normal troponin (HR: 1.67; 95% CI: 0.75 to 3.70; p for interaction = 0.03). Conclusions The present study does not allow a definite conclusion about the benefit of an EA approach when applied systematically among elderly patients with NSTEACS. The finding of a significant interaction for the treatment effect according to troponin status at baseline should be confirmed in a larger size trial. (Italian Elderly ACS Study; NCT00510185 )
Objectives We appraised the incidence and clinical outcomes of patients who were treated with the valve-in-valve (ViV) technique for hemodynamically destabilizing paraprosthetic leak (PPL). ...Background Device malpositioning causing severe PPL after transcatheter aortic valve implantation is not an uncommon finding. It occurs after release of the prosthesis, leading to hemodynamic compromise. It can be managed successfully in selected cases with implantation of a second device inside the malpositioned primary prosthesis (ViV technique). Methods Consecutive patients (n = 663) who underwent transcatheter aortic valve implantation with the 18-F CoreValve ReValving System (Medtronic, Inc., Minneapolis, Minnesota) at 14 centers across Italy were included in this prospective web-based registry. We identified patients treated with the ViV technique for severe PPL and analyzed their clinical and echocardiographic outcomes. Primary end points were major adverse cerebrovascular and cardiac events and prosthesis performance at the 30-day and midterm follow-up. Results Overall procedural success was obtained in 650 patients (98.0%). The ViV technique was used in 24 (3.6%) of 663 patients. The 30-day major adverse cerebrovascular and cardiac event rates were 7.0% and 0% in patients undergoing the standard procedure and ViV technique, respectively (p = 0.185); the mortality rates were 5.6% versus 0% in patients undergoing the standard procedure and ViV technique, respectively (p = 0.238). There was an improvement in the mean transaortic gradient in all patients without significant difference between the 2 groups (from 52.1 ± 17.1 mm Hg and 45.4 ± 14.8 mm Hg p = 0.060 to 10.1 ± 4.2 mm Hg and 10.5 ± 5.2 mm Hg, respectively p = 0.838). At 12 months, the major adverse cerebrovascular and cardiac event rates in the standard procedure and ViV technique groups were 4.5% and 14.1%, respectively (p = 0.158), and the mortality rates were 4.5% versus 13.7%, respectively (p = 0.230). Conclusions This large, multicenter registry provides important information about the feasibility, safety, and efficacy of the ViV technique with the third-generation CoreValve ReValving System. The clinical and echocardiographic end points compare favorably with those of patients undergoing the standard procedure. The ViV technique offers a viable therapeutic option in patients with acute significant PPL without recourse to emergent surgery.
Objectives Aortic valve implantation through peripheral vascular access is an option for high-risk patients with severe aortic valve stenosis. The authors aimed to compare the acute effect of ...endovascular and surgical aortic valve procedures on left ventricular diastolic function. Design A case-matched, nonrandomized study. Setting A university hospital. Participants Patients with aortic stenosis. Interventions B-natriuretic peptide was measured in 30 patients with a logistic EuroSCORE ≥20% undergoing endovascular aortic valve implantation. Patients were case matched (age, mitral flow propagation velocity, mitral annulus early diastolic velocity, and B-natriuretic peptide measurement) with 30 control patients undergoing surgical aortic valve replacement through sternotomy. Left ventricular diastole was evaluated initially and after valve procedures with echocardiography by mitral flow propagation velocity and mitral annulus early diastolic velocity. Measurements and Main Results B-natriuretic peptide was similar preoperatively in the 2 groups (346 188-438 v 367 211-458 pg/mL) and higher ( p = 0.006) in the surgical group postoperatively (389.5 237-479 v 710.5 389-822 pg/mL), with a postprocedural statistically significant increase only in the surgical group. Diastolic function was similar in the 2 groups preoperatively, improved postoperatively in the endovascular group, and worsened in the surgical group. Conclusions B-natriuretic peptide increased after surgical but not after endovascular aortic valve replacement. Furthermore, endovascular aortic valve implantation acutely improved left ventricular diastolic function as documented by increases in mitral flow propagation velocity and mitral annulus early diastolic velocity.
Objectives The FINESSE-ANGIO (Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events–Angiographic) study evaluated acute treatment effects on infarct-related artery (IRA) patency and ...angiographic correlates of coronary microcirculatory function. Background The FINESSE trial evaluated the effects on clinical outcomes of primary percutaneous coronary intervention (PCI) facilitated with pre–catheterization laboratory administration of abciximab with half-dose reteplase (combination-facilitated group), abciximab alone (abciximab-facilitated group), or with abciximab administered immediately before the procedure (primary PCI). Methods The FINESSE-ANGIO substudy compared the effects of the 3 treatment strategies on patency (TIMI Thrombolysis In Myocardial Infarction flow grade 2/3) of the IRA at basal coronary angiography. The secondary efficacy end points were corrected TIMI frame count, percentage of patients achieving TIMI flow grade 3, and the percentage achieving myocardial blush grade 2/3 of the IRA at post-PCI angiography. All angiographies were evaluated at a central core laboratory. Results Of the 2,452 FINESSE patients, 637 were included in the FINESSE-ANGIO substudy. Patients in the combination-facilitated group exhibited significantly higher rates of baseline IRA patency compared with the abciximab-facilitated and the primary PCI groups (76.1% vs. 43.7% and 32.7%, respectively; p < 0.0001 for both; p = 0.025 abciximab-facilitated vs. primary PCI). There were no significant differences in the post-PCI corrected TIMI frame count (17.1 ± 15.8, 17.4 ± 17.3, and 15.8 ± 14.1) or the rates of post-PCI TIMI flow grade 3 (79.8%, 77.7%, and 76.6%), myocardial blush grade 2/3 (85.6%, 79.5%, and 86.4%), respectively. Conclusions Pre–catheterization laboratory administration of abciximab alone and especially in combination with half-dose reteplase resulted in higher rates of IRA patency at baseline coronary angiography compared with no pre-treatment. However, post-procedural angiographic and microcirculatory variables were unaffected by facilitation therapy.
Interatrial communications (ICs) have been linked to paradoxic embolism, which may be prevented using both surgical and percutaneous interventions. The case of a 61-year-old woman with a history of ...transient cerebral ischemic attack who developed repetitive ventricular arrhythmias and an intermittent left branch bundle block immediately after percutaneous closure of an IC is described. Transthoracic echocardiography showed that the device had migrated into the left ventricular outflow tract, and the patient consequently underwent emergency cardiac surgery to retrieve the device and repair the IC. In conclusion, percutaneous transcatheter closure of ICs is more rapid and less invasive compared with surgery, but nevertheless may be associated with significant short-term morbidity.
Randomized Comparison of Sirolimus and Paclitaxel Drug-Eluting Stents for Long Lesions in the Left Anterior Descending Artery: An Intravascular Ultrasound Study Anna Sonia Petronio, Marco De Carlo, ...Giulia Branchitta, Barbara Papini, Nicola Ciabatti, Roberto Gistri, Bernardo Cortese, Gherardo Gherarducci, Antonio Barsotti The objective of this prospective randomized study was to verify whether the superiority of the sirolimus-eluting stent (SES) in inhibiting neointimal hyperplasia could be demonstrated in complex coronary lesions. The SES was compared with the paclitaxel-eluting stent (PES) in long lesions of the left anterior descending artery with intravascular ultrasound (IVUS) and quantitative angiography. Late luminal loss and mean neointimal hyperplasia were significantly lower in the SES group compared with the PES group, and peri-stent plaque area was significantly reduced in the SES group only. Both groups had excellent IVUS and angiographic results at 9-month follow up.
Summary Background Whether the two drug-eluting stents approved by the US Food and Drug Administration—a sirolimus-eluting stent and a paclitaxel-eluting stent—are associated with increased risks of ...death, myocardial infarction, or stent thrombosis compared with bare-metal stents is uncertain. Our aim was to compare the safety and effectiveness of these stents. Methods We searched relevant sources from inception to March, 2007, and contacted investigators and manufacturers to identify randomised controlled trials in patients with coronary artery disease that compared drug-eluting with bare-metal stents, or that compared sirolimus-eluting stents head-to-head with paclitaxel-eluting stents. Safety outcomes included mortality, myocardial infarction, and definite stent thrombosis; the effectiveness outcome was target lesion revascularisation. We included 38 trials (18 023 patients) with a follow-up of up to 4 years. Trialists and manufacturers provided additional data on clinical outcomes for 29 trials. We did a network meta-analysis with a mixed-treatment comparison method to combine direct within-trial comparisons between stents with indirect evidence from other trials while maintaining randomisation. Findings Mortality was similar in the three groups: hazard ratios (HR) were 1·00 (95% credibility interval 0·82–1·25) for sirolimus-eluting versus bare-metal stents, 1·03 (0·84–1·22) for paclitaxel-eluting versus bare-metal stents, and 0·96 (0·83–1·24) for sirolimus-eluting versus paclitaxel-eluting stents. Sirolimus-eluting stents were associated with the lowest risk of myocardial infarction (HR 0·81, 95% credibility interval 0·66–0·97, p=0·030 vs bare-metal stents; 0·83, 0·71–1·00, p=0·045 vs paclitaxel-eluting stents). There were no significant differences in the risk of definite stent thrombosis (0 days to 4 years). However, the risk of late definite stent thrombosis (>30 days) was increased with paclitaxel-eluting stents (HR 2·11, 95% credibility interval 1·19–4·23, p=0·017 vs bare-metal stents; 1·85, 1·02–3·85, p=0·041 vs sirolimus-eluting stents). The reduction in target lesion revascularisation seen with drug-eluting stents compared with bare-metal stents was more pronounced with sirolimus-eluting stents than with paclitaxel-eluting stents (0·70, 0·56–0·84; p=0·0021). Interpretation The risks of mortality associated with drug-eluting and bare-metal stents are similar. Sirolimus-eluting stents seem to be clinically better than bare-metal and paclitaxel-eluting stents.
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