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1.
Arch Cardiovasc Dis ; 115(4): 214-224, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-35537922

RESUMO

BACKGROUND: Previous studies provided conflicting data on the impact of new conduction abnormalities (CA), including new left bundle branch block (LBBB) and permanent pacemaker (PPM) implantation, on patient outcomes after transcatheter aortic valve implantation (TAVI). AIMS: To investigate the effect of new-onset CA after TAVI on long-term clinical outcomes and the impact of new CA depending on patient baseline profile. METHODS: Using data from a prospective TAVI registry (NCT01368250), patients without pre-existing LBBB or PPM were included in this study, and were stratified into three groups: no CA, new LBBB and new PPM after TAVI. RESULTS: Among 2370 eligible patients, 1533 (64.7%) had no CA, 336 (14.2%) had new LBBB and 501 (21.1%) had new PPM after TAVI. At 5 years, patients with new LBBB had an increased risk of all-cause death (adjusted hazard ratio [HRadjusted] 1.41, 95% confidence interval [CI] 1.04-1.92; P=0.026), whereas patients with new PPM had a numerically increased risk of mortality (HRadjusted 1.26, 95% CI 0.99-1.60; P=0.065) compared to patients without CA. There was no significant difference in cardiovascular mortality between groups (HRadjusted for new LBBB 1.33, 95% CI 0.91-1.97; P=0.15; HRadjusted for new PPM 1.25, 95% CI 0.93-1.68; P=0.13]). The adverse effects of new CA were consistent across all subgroups except for the impact of new PPM stratified by balloon-expandable versus self-expanding or mechanically expanding valves (Pinteraction=0.004). CONCLUSIONS: New-onset LBBB after TAVI was associated with an increased risk of 5-year all-cause mortality, while new PPM implantation conferred a non-significant trend.

2.
JAMA ; 327(18): 1771-1781, 2022 05 10.
Artigo em Inglês | MEDLINE | ID: mdl-35368058

RESUMO

Importance: Coronary plaques that are prone to rupture and cause adverse cardiac events are characterized by large plaque burden, large lipid content, and thin fibrous caps. Statins can halt the progression of coronary atherosclerosis; however, the effect of the proprotein convertase subtilisin kexin type 9 inhibitor alirocumab added to statin therapy on plaque burden and composition remains largely unknown. Objective: To determine the effects of alirocumab on coronary atherosclerosis using serial multimodality intracoronary imaging in patients with acute myocardial infarction. Design, Setting, and Participants: The PACMAN-AMI double-blind, placebo-controlled, randomized clinical trial (enrollment: May 9, 2017, through October 7, 2020; final follow-up: October 13, 2021) enrolled 300 patients undergoing percutaneous coronary intervention for acute myocardial infarction at 9 academic European hospitals. Interventions: Patients were randomized to receive biweekly subcutaneous alirocumab (150 mg; n = 148) or placebo (n = 152), initiated less than 24 hours after urgent percutaneous coronary intervention of the culprit lesion, for 52 weeks in addition to high-intensity statin therapy (rosuvastatin, 20 mg). Main Outcomes and Measures: Intravascular ultrasonography (IVUS), near-infrared spectroscopy, and optical coherence tomography were serially performed in the 2 non-infarct-related coronary arteries at baseline and after 52 weeks. The primary efficacy end point was the change in IVUS-derived percent atheroma volume from baseline to week 52. Two powered secondary end points were changes in near-infrared spectroscopy-derived maximum lipid core burden index within 4 mm (higher values indicating greater lipid content) and optical coherence tomography-derived minimal fibrous cap thickness (smaller values indicating thin-capped, vulnerable plaques) from baseline to week 52. Results: Among 300 randomized patients (mean [SD] age, 58.5 [9.7] years; 56 [18.7%] women; mean [SD] low-density lipoprotein cholesterol level, 152.4 [33.8] mg/dL), 265 (88.3%) underwent serial IVUS imaging in 537 arteries. At 52 weeks, mean change in percent atheroma volume was -2.13% with alirocumab vs -0.92% with placebo (difference, -1.21% [95% CI, -1.78% to -0.65%], P < .001). Mean change in maximum lipid core burden index within 4 mm was -79.42 with alirocumab vs -37.60 with placebo (difference, -41.24 [95% CI, -70.71 to -11.77]; P = .006). Mean change in minimal fibrous cap thickness was 62.67 µm with alirocumab vs 33.19 µm with placebo (difference, 29.65 µm [95% CI, 11.75-47.55]; P = .001). Adverse events occurred in 70.7% of patients treated with alirocumab vs 72.8% of patients receiving placebo. Conclusions and Relevance: Among patients with acute myocardial infarction, the addition of subcutaneous biweekly alirocumab, compared with placebo, to high-intensity statin therapy resulted in significantly greater coronary plaque regression in non-infarct-related arteries after 52 weeks. Further research is needed to understand whether alirocumab improves clinical outcomes in this population. Trial Registration: ClinicalTrials.gov Identifier: NCT03067844.


Assuntos
Doença da Artéria Coronariana , Inibidores de Hidroximetilglutaril-CoA Redutases , Infarto do Miocárdio , Placa Aterosclerótica , Idoso , Anticorpos Monoclonais Humanizados/uso terapêutico , LDL-Colesterol , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/tratamento farmacológico , Método Duplo-Cego , Feminino , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/complicações , Infarto do Miocárdio/tratamento farmacológico , Placa Aterosclerótica/complicações , Placa Aterosclerótica/diagnóstico por imagem , Placa Aterosclerótica/tratamento farmacológico , Resultado do Tratamento
3.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-35437213

RESUMO

INTRODUCTION AND OBJECTIVES: The DECADE cooperation is a pooled analysis of individual patient data from drug-eluting stent (DES) trials with a 10-year follow-up. This analysis reports the risk of definite stent thrombosis (ST) through to 10 years after percutaneous coronary intervention (PCI) in patients treated with early- and new-generation DES. METHODS: Individual patient data from 5 DES trials with a 10-year follow-up were pooled. The primary endpoint was definite ST up to 10 years after PCI. Patients were divided into 2 groups as per the generation of DES implanted (early and new DES). Individual participant data were analyzed using a 1-stage approach. RESULTS: We included 9700 patients, 6866 in the new DES group and 2834 in the early DES group. Through to 10 years, definite ST occurred in 69 of 6866 patients treated with new DES and in 91 of 2834 patients treated with early DES (1.0% vs 3.5%, adjusted hazard ratio, 0.32; 95%CI, 0.23-0.45). The rate of definite ST was lower in the new DES group than in the early DES group from 1 to 5 years (rate ratio, 0.14; 95%CI, 0.08-0.26) and from 5 to 10 years (rate ratio, 0.23; 95%CI, 0.08-0.61) after PCI. CONCLUSIONS: The incidence of definite ST through to 10 years after PCI with new-generation DES was 1%. New-generation DES are associated with a lower 10-year incidence of definite ST than early-generation DES, particularly beyond 1 year after PCI.

4.
Heart ; 2022 Mar 29.
Artigo em Inglês | MEDLINE | ID: mdl-35351823

RESUMO

BACKGROUND: Rheumatic heart disease (RHD) accounts for the highest number of deaths from valvular heart disease globally. Yet, rheumatic aortic stenosis (AS) was excluded from landmark studies investigating the safety and efficacy of transcatheter aortic valve implantation (TAVI). We aimed to describe the clinical and anatomical characteristics of patients with rheumatic AS undergoing TAVI, and to compare procedural and clinical outcomes with patients undergoing TAVI for degenerative AS. METHODS: In a prospective TAVI registry, patients with rheumatic AS were identified based on International Classification of Diseases version 10 codes and/or a documented history of acute rheumatic fever and/or the World Heart Federation criteria for echocardiographic diagnosis of RHD, and were propensity score-matched in a 1:4 ratio to patients with degenerative AS. RESULTS: Among 2329 patients undergoing TAVI, 105 (4.5%) had rheumatic AS. Compared with patients with degenerative AS, patients with rheumatic AS were more commonly female, older, had higher surgical risk and more commonly suffered from multivalvular heart disease. In the unmatched cohort, both technical success (85.7% vs 85.9%, p=0.887) and 1-year cardiovascular mortality (10.0% vs 8.6%; HR 1.16, 95% CI 0.61 to 2.18, p=0.656) were comparable between patients with rheumatic and degenerative AS. In contrast, patients with rheumatic AS had lower rates of 30-day and 1-year cardiovascular mortality compared with matched patients with degenerative AS (1.9% vs 8.9%, adjusted HR (HRadj) 0.18, 95% CI 0.04 to 0.80, p=0.024; and 10.0% vs 20.3%, HRadj 0.44, 95% CI 0.24 to 0.84, p=0.012, respectively). CONCLUSION: TAVI may be a safe and effective treatment strategy for selected elderly patients with rheumatic AS. TRIAL REGISTRATION NUMBER: NCT01368250.

5.
J Am Heart Assoc ; 11(10): e024291, 2022 May 17.
Artigo em Inglês | MEDLINE | ID: mdl-35229616

RESUMO

Background In the GLOBAL LEADERS trial, ticagrelor monotherapy beyond 1 month compared with standard antiplatelet regimens after coronary stent implantation did not improve outcomes at intention-to-treat analysis. Considerable differences in treatment adherence between the experimental and control groups may have affected the intention-to-treat results. In this reanalysis of the GLOBAL LEADERS trial, we compared the experimental and control treatment strategies in a per-protocol analysis of patients who did not deviate from the study protocol. Methods and Results Baseline and postrandomization information were used to classify whether and when patients were deviating from the study protocol. With logistic regressions, we derived time-varying inverse probabilities of nondeviation from protocol to reconstruct the trial population without protocol deviation. The primary end point was a composite of all-cause mortality or nonfatal Q-wave myocardial infarction at 2 years. At 2-year follow-up, 1103 (13.8%) of 7980 patients in the experimental group and 785 (9.8%) of 7988 patients in the control group qualified as protocol deviators. At per-protocol analysis, the rate ratio for the primary end point was 0.88 (95% CI, 0.75-1.03; P=0.10) on the basis of 274 versus 325 events in the experimental versus control group. The rate ratio for the key safety end point of major bleeding was 1.00 (95% CI, 0.79-1.26; P=0.99). The per-protocol and intention-to-treat effect estimates were overall consistent. Conclusions Among patients who complied with the study protocol in the GLOBAL LEADERS trial, ticagrelor plus aspirin for 1 month followed by ticagrelor monotherapy was not superior to 1-year standard dual antiplatelet therapy followed by aspirin alone at 2 years after coronary stenting. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01813435.

6.
Europace ; 2022 Mar 07.
Artigo em Inglês | MEDLINE | ID: mdl-35253840

RESUMO

AIMS: No studies have compared Watchman 2.5 (W2.5) with Watchman FLX (FLX) devices to date. We aimed at comparing the FLX with W2.5 devices with respect to clinical outcomes, left atrial appendage (LAA) sealing properties and device-related thrombus (DRT). METHODS AND RESULTS: All consecutive left atrial appendage closure (LAAC) procedures performed at two European centres between November 2017 and February 2021 were included. Procedure-related complications and net adverse cardiovascular events (NACE) at 6 months after LAAC were recorded. At 45-day computed tomography (CT) follow-up, intra- (IDL) and peri- (PDL) device leak, residual patent neck area (RPNA), and DRT were assessed by a Corelab. Out of 144 LAAC consecutive procedures, 71 and 73 interventions were performed using W2.5 and FLX devices, respectively. There were no differences in terms of procedure-related complications (4.2% vs. 2.7%, P = 0.626). At 45-day CT, the FLX was associated with lower frequency of IDL [21.3% vs. 40.0%; P = 0.032; odds ratio (OR): 0.375; 95% confidence interval (CI): 0.160-0.876; P = 0.024], similar rate of PDL (29.5% vs. 42.0%; P = 0.170), and smaller RPNA [6 (0-36) vs. 40 (6-115) mm2; P = 0.001; OR: 0.240; 95% CI: 0.100-0.577; P = 0.001] compared with the W2.5 group. At 45 days, rate of DRT as detected by CT and/or transoesophageal echocardiography (TOE), was higher with W2.5 (6.0% vs. 0%, P = 0.045). At 6-month follow-up, NACE did not differ between groups. CONCLUSIONS: In this cohort of consecutive LAACs, FLX as compared to W2.5, was associated with similar procedure-related complications and 6-month NACE, but with improved LAA neck coverage, and lower IDL and DRT.

7.
Catheter Cardiovasc Interv ; 99(6): 1908-1917, 2022 May.
Artigo em Inglês | MEDLINE | ID: mdl-35170846

RESUMO

BACKGROUND: Increased left ventricular afterload resulting from severe aortic stenosis (AS) leads to progressive cardiac remodeling. Left atrial enlargement (LAE) is an early manifestation in a series of maladaptive changes and may affect clinical outcomes after valvular replacement therapy. The aim of this study is to determine the impact of LAE on clinical outcomes in symptomatic patients with severe AS undergoing transcatheter aortic valve implantation (TAVI). METHODS: In a prospective single-center TAVI registry, we analyzed LA dimensions measured by echocardiography before intervention. Patients with atrial fibrillation or concomitant mitral valve disease were excluded. LAE was defined as indexed LA volume >34 ml/m2 . The primary endpoint was cardiovascular death (CVD) at 1 year. RESULTS: Among 1663 patients undergoing TAVI between August 2007 and December 2016, 768 (46.2%) were eligible for the present analysis and 486 patients had LAE. The prevalence of LAE was higher in males (68.3%) as compared to females (58.8%). Patients with LAE were older (82.3 ± 6.7 years vs. 80.0 ± 6.4 years) and had a higher STS-PROM score (6.1 ± 4.7% vs. 4.7 ± 2.9%). After adjustment, patients with LAE had an increased risk of CVD at 1-year compared to patients with normal LA dimensions (49 [10.4%] vs. 8 [2.9%]; HRadj , 3.52; 95% CI, 1.66-7.44)]. In multivariable analysis, LAE was independently associated with an increased risk of CVD at 1-year (HRadj , 3.52; 95% CI, 1.66-7.44). CONCLUSIONS: LAE secondary to AS was documented in a significant proportion of patients undergoing TAVI and was associated with a more than threefold increased risk of CVD at 1-year.

8.
J Am Coll Cardiol ; 79(6): 513-526, 2022 02 15.
Artigo em Inglês | MEDLINE | ID: mdl-35144742

RESUMO

BACKGROUND: Definitions of periprocedural myocardial infarction (MI) differ with respect to biomarker threshold as well as ancillary criteria for myocardial ischemia and are limited in terms of validation. OBJECTIVES: This study evaluated the frequency and impact of periprocedural MI by using various MI definitions among patients with chronic coronary syndrome (CCS) undergoing percutaneous coronary intervention (PCI). METHODS: Between 2010 and 2018, periprocedural MIs were assessed according to the third and fourth Universal Definition of Myocardial Infarction (UDMI), Academic Research Consortium-2 (ARC-2), and Society for Cardiovascular Angiography and Interventions (SCAI) criteria based on high-sensitivity troponin in patients with CCS undergoing PCI enrolled into the Bern PCI registry. The primary endpoint was cardiac death at 1 year. RESULTS: Among 4,404 patients with CCS, periprocedural MI defined by the third UDMI, fourth UDMI, ARC-2, and SCAI were observed in 18.0%, 14.9%, 2.0%, and 2.0% of patients, respectively. Among patients with periprocedural MI defined by the third UDMI, fourth UDMI, ARC-2, and SCAI, cardiac mortality at 1 year was 2.9%, 3.0%, 5.8%, and 10.0%. The ARC-2 (HR: 3.90; 95% CI: 1.54-9.93) and SCAI (HR: 7.66; 95% CI: 3.64-16.11) were more relevant compared with the third UDMI (HR: 1.76; 95% CI: 1.04-3.00) and fourth UDMI (HR: 1.93; 95% CI: 1.11-3.37) for cardiac death at 1 year. CONCLUSIONS: Among patients with CCS undergoing PCI, periprocedural MI defined according to the ARC-2 and SCAI criteria was 7 to 9 times less frequent compared with the third and fourth UDMI. Periprocedural MI defined by using the ARC-2 and SCAI were more prognostic for cardiac death at 1 year compared with the third and fourth UDMI. (CARDIOBASE Bern PCI Registry; NCT02241291).


Assuntos
Doença da Artéria Coronariana/complicações , Infarto do Miocárdio/epidemiologia , Intervenção Coronária Percutânea , Sistema de Registros , Idoso , Biomarcadores/sangue , Doença da Artéria Coronariana/cirurgia , Feminino , Seguimentos , Humanos , Incidência , Masculino , Infarto do Miocárdio/sangue , Infarto do Miocárdio/etiologia , Oligopeptídeos , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Síndrome , Troponina/sangue
9.
JACC Cardiovasc Interv ; 15(4): 353-364, 2022 02 28.
Artigo em Inglês | MEDLINE | ID: mdl-35093281

RESUMO

OBJECTIVES: The authors aimed to investigate the rates, predictors, and prognostic impact of technical success in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: The Valve Academic Research Consortium-3 (VARC-3) has introduced a composite endpoint to assess the immediate technical success of TAVR. METHODS: In the prospective Bern TAVR registry, patients were stratified according to VARC-3 technical success. Technical failure differentiated between vascular and cardiac complications. RESULTS: In a total of 1,624 patients undergoing TAVR between March 2012 and December 2019, 1,435 (88.4%) patients had technical success. Among 189 patients with technical failure, 140 (8.6%) had vascular and 49 (3.0%) had cardiac technical failure. Female, larger device landing zone calcium volume, and the early term of the study period were associated with an increased risk for cardiac technical failure, whereas higher body mass index and the use of the Prostar (Abbott Vascular Inc) MANTA (Teleflex) (compared with the ProGlide [Abbott Vascular Inc]) were predictors of vascular technical failure. In multivariable analysis, technical failure conferred an increased risk for cardiovascular death or stroke (HR: 2.01; 95% CI: 1.37-2.95). The adverse effect remained when stratified to cardiac (HR: 2.62; 95% CI: 1.38-4.97) or vascular technical failure (HR: 1.95; 95% CI: 1.28-2.95) and limited to the periprocedural period (0-30 days: HR: 3.42 [95% CI: 2.05-5.69]; 30-360 days: HR: 1.36 [95% CI: 0.79-2.35]; P for interaction = 0.002). CONCLUSIONS: Technical failure according to VARC-3 was observed in 1 of 10 patients undergoing TAVR and was associated with a 2-fold increased risk of the composite outcome at 1 year after TAVR. (Swiss TAVI Registry; NCT01368250).


Assuntos
Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/etiologia , Estenose da Valva Aórtica/cirurgia , Feminino , Humanos , Estudos Prospectivos , Sistema de Registros , Fatores de Risco , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
10.
Am Heart J ; 247: 33-41, 2022 May.
Artigo em Inglês | MEDLINE | ID: mdl-35092722

RESUMO

BACKGROUND: Activation of inflammatory pathways during acute myocardial infarction contributes to infarct size and left ventricular (LV) remodeling. The present prospective randomized clinical trial was designed to test the efficacy and safety of broad-spectrum anti-inflammatory therapy with a mammalian target of rapamycin (mTOR) inhibitor to reduce infarct size. DESIGN: Controlled-Level EVERolimus in Acute Coronary Syndrome (CLEVER-ACS, clinicaltrials.gov NCT01529554) is a phase II randomized, double-blind, multi-center, placebo-controlled trial on the effects of a 5-day course of oral everolimus on infarct size, LV remodeling, and inflammation in patients with acute ST-elevation myocardial infarction (STEMI). Within 5 days of successful primary percutaneous coronary intervention (pPCI), patients are randomly assigned to everolimus (first 3 days: 7.5 mg every day; days 4 and 5: 5.0 mg every day) or placebo, respectively. The primary efficacy outcome is the change from baseline (defined as 12 hours to 5 days after pPCI) to 30-day follow-up in myocardial infarct size as measured by cardiac magnetic resonance imaging (CMRI). Secondary endpoints comprise corresponding changes in cardiac and inflammatory biomarkers as well as microvascular obstruction and LV volumes assessed by CMRI. Clinical events, laboratory parameters, and blood cell counts are reported as safety endpoints at 30 days. CONCLUSION: The CLEVER-ACS trial tests the hypothesis whether mTOR inhibition using everolimus at the time of an acute STEMI affects LV infarct size following successful pPCI.


Assuntos
Síndrome Coronariana Aguda , Infarto Miocárdico de Parede Anterior , Infarto do Miocárdio , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Síndrome Coronariana Aguda/tratamento farmacológico , Arritmias Cardíacas , Método Duplo-Cego , Everolimo/uso terapêutico , Humanos , Imageamento por Ressonância Magnética , Infarto do Miocárdio/tratamento farmacológico , Estudos Prospectivos , Infarto do Miocárdio com Supradesnível do Segmento ST/tratamento farmacológico , Serina-Treonina Quinases TOR/uso terapêutico , Resultado do Tratamento , Remodelação Ventricular
11.
Circulation ; 145(10): 724-738, 2022 03 08.
Artigo em Inglês | MEDLINE | ID: mdl-34747186

RESUMO

BACKGROUND: No study has so far compared Amulet with the new Watchman FLX in terms of residual left atrial appendage (LAA) patency or clinical outcomes in patients undergoing percutaneous LAA closure. METHODS: In the investigator-initiated SWISS APERO trial (Comparison of Amulet Versus Watchman/FLX Device in Patients Undergoing Left Atrial Appendage Closure), patients undergoing LAA closure were randomly assigned (1:1) open label to receive Amulet or Watchman 2.5 or FLX (Watchman) across 8 European centers. The primary end point was the composite of justified crossover to a nonrandomized device during LAA closure procedure or residual LAA patency detected by cardiac computed tomography angiography (CCTA) at 45 days. The secondary end points included procedural complications, device-related thrombus, peridevice leak at transesophageal echocardiography, and clinical outcomes at 45 days. RESULTS: Between June 2018 and May 2021, 221 patients were randomly assigned to Amulet (111 [50.2%]) or Watchman (110 [49.8%]), of whom 25 (22.7%) patients included before October 2019 received Watchman 2.5, and 85 (77.3%) patients received Watchman FLX. The primary end point was assessable in 205 (92.8%) patients and occurred in 71 (67.6%) patients receiving Amulet and 70 (70.0%) patients receiving Watchman, respectively (risk ratio, 0.97 [95% CI, 0.80-1.16]; P=0.713). A single justified crossover occurred in a patient with Amulet who fulfilled LAA patency criteria at 45-day CCTA. Major procedure-related complications occurred more frequently in the Amulet group (9.0% versus 2.7%; P=0.047) because of more frequent bleeding (7.2% versus 1.8%). At 45 days, the peridevice leak rate at transesophageal echocardiography was higher with Watchman than with Amulet (27.5% versus 13.7%, P=0.020), albeit none was major (ie, >5 mm), whereas device-related thrombus was detected in 1 (0.9%) patient with Amulet and 3 (3.0%) patients with Watchman at CCTA and in 2 (2.1%) and 5 (5.5%) patients at transesophageal echocardiography, respectively. Clinical outcomes at 45 days did not differ between the groups. CONCLUSIONS: Amulet was not associated with a lower rate of the composite of crossover or residual LAA patency compared with Watchman at 45-day CCTA. Amulet, however, was associated with lower peridevice leak rates at transesophageal echocardiography, higher procedural complications, and similar clinical outcomes at 45 days compared with Watchman. The clinical relevance of CCTA-detected LAA patency requires further investigation. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03399851.


Assuntos
Apêndice Atrial , Fibrilação Atrial , Procedimentos Cirúrgicos Cardíacos , Apêndice Atrial/diagnóstico por imagem , Apêndice Atrial/cirurgia , Fibrilação Atrial/diagnóstico por imagem , Fibrilação Atrial/cirurgia , Cateterismo Cardíaco/efeitos adversos , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Ecocardiografia Transesofagiana/métodos , Humanos , Resultado do Tratamento
12.
J Cardiovasc Comput Tomogr ; 16(3): 215-221, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-34756819

RESUMO

BACKGROUND: Current guidelines favor transcatheter aortic valve implantation (TAVI) over surgical aortic valve replacement in patients with porcelain aorta (PAo). The clinical relevance of PAo in patients undergoing TAVI is however incompletely understood. The purpose of this study is to evaluate clinical outcome of patients with PAo undergoing TAVI. METHODS: Consecutive patients undergoing TAVI were enrolled in a prospective single-center registry. Presence of PAo was evaluated by ECG-gated multi-slice computed tomography prior to the intervention. The primary endpoint was disabling stroke. RESULTS: Among 2199 patients (mean age, 82.0 â€‹± â€‹6.3 years; 1135 females [51.6%]) undergoing TAVI between August 2007 and December 2019, 114 patients (5.2%) met VARC-2 criteria for PAo. Compared to individuals without PAo, patients with PAo were younger (79.4 â€‹± â€‹7.4 years vs. 82.1 â€‹± â€‹6.2 years; p â€‹< â€‹0.001), had a lower left ventricular ejection fraction (51.8 â€‹± â€‹14.9% vs. 55.3 â€‹± â€‹14.2%; p â€‹= â€‹0.009) and higher STS-PROM Scores (6.5 â€‹± â€‹4.3% vs. 4.9 â€‹± â€‹3.4%; p â€‹< â€‹0.001). At 1 year, disabling stroke occurred more often in patients with PAo (7.2%) than in those without (3.0%) (HRadj, 2.49; 95% CI, 1.12-5.55). The risk difference emerged within 30 days after TAVI (HRadj, 3.70; 95% CI, 1.52-9.03), and was driven by a high PAo-associated risk of disabling stroke in patients with alternative access (HRadj, 5.79; 95% CI, 1.38-24.3), not in those with transfemoral (HRadj, 1.47; 95% CI 0.45-4.85). CONCLUSIONS: TAVI patients with PAo had a more than three-fold increased risk of periprocedural disabling stroke compared to patients with no PAo. The difference was driven by a higher risk of stroke in patients treated by alternative access.


Assuntos
Estenose da Valva Aórtica , Acidente Vascular Cerebral , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Aorta/cirurgia , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/etiologia , Estenose da Valva Aórtica/cirurgia , Porcelana Dentária , Feminino , Humanos , Masculino , Valor Preditivo dos Testes , Estudos Prospectivos , Sistema de Registros , Medição de Risco , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/etiologia , Volume Sistólico , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Resultado do Tratamento , Função Ventricular Esquerda
14.
Am Heart J ; 244: 94-106, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34788603

RESUMO

BACKGROUND: Ascending aortic root anatomy is routinely evaluated on pre-procedural multi-detector computed tomography (MDCT). However, its clinical significance has not been adequately studied. We aimed to investigate the impact of the sinus of Valsalva (SOV) dimension on clinical outcomes in patients undergoing transcatheter aortic valve implantation (TAVI). METHODS: In a prospective TAVI registry, we retrospectively assessed SOV dimensions by pre-procedural MDCT. Patients were stratified according to tertiles of SOV diameter indexed to body surface area (SOVi). The primary endpoint was all-cause mortality at 1 year. RESULTS: Among 2066 consecutive patients undergoing TAVI between August 2007 and June 2018, 1554 patients were eligible for the present analysis. Patients in the large SOVi group were older (83 ± 6 vs 82 ± 6 vs 81 ± 6; P < .001) and had a higher Society of Thoracic Surgeons Predicted Risk of Mortality (6.3 ± 3.8 vs 5.1 ± 3.1 vs 4.9 ± 3.5; P < .001) than those in the other groups. Patients in the large SOVi group had a higher incidence of moderate or severe paravalvular regurgitation (11.9% vs 4.5% vs 3.5%; P < .001). At 1 year, a large SOVi was independently associated with an increased risk of mortality (HR: 1.62; 95% CI: 1.19-2.21; P = .002) and major or life-threatening bleeding (HR: 1.30; 95% CI: 1.02-1.65; P = .035). CONCLUSIONS: Dilatation of the aortic root at the SOV was associated with adverse outcomes after TAVI. The assessment of the aortic root should be integrated into the risk stratification system in patients undergoing TAVI.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Seio Aórtico , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Humanos , Estudos Prospectivos , Estudos Retrospectivos , Seio Aórtico/diagnóstico por imagem , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
15.
Cardiovasc Revasc Med ; 34: 3-10, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-33653633

RESUMO

BACKGROUND: Thin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) have been shown to reduce target lesion failure (TLF) at one-year follow-up compared with durable polymer everolimus-eluting stents (DP-EES) among patients with acute coronary syndrome (ACS). The long-term clinical benefits of thin-strut BP-SES over DP-EES in ACS patients after complete degradation of the polymer coating remain uncertain. METHODS: We performed a post-hoc subgroup analysis of ACS patients included into the BIOSCIENCE randomized trial (NCT01443104). The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction or clinically indicated target lesion revascularization, at 5 years. RESULTS: Among 2119 patients enrolled between March 2012 and May 2013, 1131 (53%) presented with ACS. The 5-year cumulative incidence of TLF was significantly lower in patients with ACS compared to chronic coronary syndrome [16.5% vs. 22.9%; rate ratio (RR), 0.69; 95% confidence interval (CI), 0.57-0.85; p < 0.001]. At 5 years, TLF occurred similarly in ACS patients treated with BP-SES and DP-EES (16.9% vs. 16.0%; RR, 1.04; 95% CI, 0.78-1.41; p = 0.78). The individual components of the primary endpoint did not differ between ACS patients treated with BP-SES or DP-EES at 5 years. Overall, there was no interaction between clinical presentation and treatment effect. CONCLUSIONS: In a subgroup analysis of the BIOSCIENCE trial, we found no difference in long-term outcomes between ACS patients treated with BP-SES or DP-EES at 5 years.


Assuntos
Síndrome Coronariana Aguda , Stents Farmacológicos , Intervenção Coronária Percutânea , Implantes Absorvíveis , Síndrome Coronariana Aguda/diagnóstico por imagem , Síndrome Coronariana Aguda/terapia , Everolimo , Humanos , Polímeros , Desenho de Prótese , Sirolimo , Resultado do Tratamento
16.
Eur Heart J Cardiovasc Pharmacother ; 8(1): 28-38, 2022 01 05.
Artigo em Inglês | MEDLINE | ID: mdl-32941620

RESUMO

AIMS: The five-item PRECISE-DAPT, integrating age, haemoglobin, white-blood-cell count, creatinine clearance, and prior bleeding, predicts bleeding risk in patients on dual antiplatelet therapy (DAPT) after stent implantation. We sought to assess whether the bleeding risk prediction offered by the PRECISE-DAPT remains valid among patients receiving ticagrelor monotherapy from 1 month onwards after coronary stenting instead of standard DAPT and having or not having centrally adjudicated bleeding endpoints. METHODS AND RESULTS: The PRECISE-DAPT was calculated in 14 928 and 7134 patients from GLOBAL LEADERS and GLASSY trials, respectively. The ability of the score to predict Bleeding Academic Research Consortium 3 or 5 bleeding was assessed and compared among patients on ticagrelor monotherapy (experimental strategy) or standard DAPT (reference strategy) from 1 month after drug-eluting stent implantation. Bleeding endpoints were investigator-reported or centrally adjudicated in GLOBAL LEADERS and GLASSY, respectively. At 2 years, the c-indexes for the score among patients treated with the experimental or reference strategy were 0.67 [95% confidence interval (CI): 0.63-0.71] vs. 0.63 (95% CI: 0.59-0.67) in GLOBAL LEADERS (P = 0.27), and 0.67 (95% CI: 0.61-0.73) vs. 0.66 (95% CI: 0.61-0.72) in GLASSY (P = 0.88). Decision curve analysis showed net benefit using the PRECISE-DAPT to guide bleeding risk assessment under both treatment strategies. Results were consistent between investigator-reported and adjudicated endpoints and using the simplified four-item PRECISE-DAPT. CONCLUSION: The PRECISE-DAPT offers a prediction model that proved similarly effective to predict clinically relevant bleeding among patients on ticagrelor monotherapy from 1 month after coronary stenting compared with standard DAPT and appears to be unaffected by the presence or absence of adjudicated bleeding endpoints.


Assuntos
Stents Farmacológicos , Intervenção Coronária Percutânea , Stents Farmacológicos/efeitos adversos , Terapia Antiplaquetária Dupla/efeitos adversos , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Inibidores da Agregação Plaquetária/efeitos adversos , Ticagrelor/efeitos adversos
18.
EuroIntervention ; 18(1): 33-42, 2022 May 15.
Artigo em Inglês | MEDLINE | ID: mdl-34930717

RESUMO

BACKGROUND: Mild paravalvular regurgitation (PVR) remains a frequent and underappreciated adverse event after transcatheter aortic valve implantation (TAVI) despite remarkable progress in device technology and implantation technique. AIMS: This study sought to investigate the impact of mild PVR after TAVI on five-year clinical outcomes. METHODS: In a prospective TAVI registry, PVR prior to discharge was retrospectively assessed in an echocardiographic core laboratory. Patients with ≥moderate PVR were excluded. Mild PVR was categorised into mild and mild-to-moderate PVR using a recently proposed unifying 5-class grading scheme. RESULTS: A total of 1,128 patients undergoing TAVI between 2007 and 2015 were enrolled. Of these, 560 patients had mild PVR, including 433 with mild (5-class) PVR and 127 with mild-to-moderate PVR. Patients with mild PVR were older (83 years vs 82 years, p=0.013) and had a higher surgical risk compared to patients with none/trace PVR (STS-PROM: 6.49±4.68 vs 5.41±3.48, p<0.001). At five years, patients with mild PVR had a higher risk of mortality than those with none/trace PVR (54.6% vs 43.8%; HRadjusted 1.26, 95% CI: 1.06-1.50). When applying the 5-class grading scheme, only mild-to-moderate PVR was associated with an increased risk of mortality at five years (mild PVR: HRadjusted 1.19, 95% CI: 0.99-1.43, mild-to-moderate PVR: HRadjusted 1.56, 95% CI: 1.20-2.02). The effect of mild PVR on five-year mortality was consistent across major subgroups. CONCLUSIONS: Mild PVR was associated with an increased risk of mortality at five years after TAVI. The detrimental effect was primarily driven by mild-to-moderate PVR using the 5-class grading scheme. CLINICAL TRIAL REGISTRATION: https://www. CLINICALTRIALS: gov. NCT01368250.

19.
Eur J Prev Cardiol ; 2021 Dec 11.
Artigo em Inglês | MEDLINE | ID: mdl-34894217

RESUMO

AIMS: Underrepresentation of migrants, women, and older adults in cardiovascular disease (CVD) trials may contribute to disparate care and survival. Among patients who underwent percutaneous coronary intervention (PCI), we aimed to investigate the associations of (i) underrepresented groups with major adverse cardiac events (MACE), CVD mortality, and non-CVD mortality, (ii) underrepresented groups with cardiac rehabilitation (CR) uptake, and (iii) CR uptake with outcomes. METHODS AND RESULTS: We included 15 211 consecutive patients from the CARDIOBASE Bern PCI registry (2009-18). In multi-state models comparing transition probabilities of events, sex was not associated with increased risk of any event. For each year increase in age, the increased risk of non-CVD and CVD mortality was 8% [95% confidence interval (CI) 6-9%]. Being migrant was associated with a lower risk of non-CVD mortality [hazard ratio (HR) (95% CI) 0.49 (0.27-0.90)] but not with CVD mortality. In logistic regression analysis, CR uptake was lower among women [odds ratio (95% CI) = 0.72 (0.57-0.86)] and older adults [0.32 (0.27-0.38)], but not among migrants. In cox regression, CR was independently associated with lower all-cause [HR (95% CI) = 0.12 (0.03-0.37)] and CVD mortality [0.1 (0.02-0.7)], but not with MACE [1.08 (0.8-1.4)]. CONCLUSION: Among underrepresented groups undergoing PCI, age, but not migration status nor sex, contributed to disparities in mortality. Migrant status did not result in lower attendance of CR. Considering the protective associations of CR on CVD mortality independent of age, sex, and migration status, the lower uptake in women and older adults is noteworthy.

20.
JACC Cardiovasc Interv ; 14(20): 2246-2256, 2021 10 25.
Artigo em Inglês | MEDLINE | ID: mdl-34600873

RESUMO

OBJECTIVES: The aims of this study were to document the prevalence of concomitant tricuspid regurgitation (TR) before and after transcatheter aortic valve replacement (TAVR), to quantify potential eligibility for transcatheter tricuspid valve intervention (TTVI), and to report clinical outcomes as a function of the severity of TR and potential candidacy for TTVI. BACKGROUND: The importance of concomitant TR in patients with severe aortic stenosis undergoing TAVR remains unclear. METHODS: In a prospective TAVR registry, the severity of TR before and after TAVR was retrospectively evaluated in an echocardiography core laboratory. RESULTS: Among 2,008 eligible patients, 1,659 patients (82.6%) had mild or less TR, 242 (12.1%) had moderate TR, 57 (2.8%) had severe TR, and 50 (2.5%) had massive TR. More than one-half of patients with moderate or greater TR had a reduction in TR, while a small proportion of patients with severe or less of TR had worsening of TR after TAVR. In contrast to TR at baseline, severe TR (adjusted HR [HRadjusted]: 1.90; 95% CI: 1.03-3.49) and massive TR (HRadjusted: 2.17; 95% CI: 1.10-4.30) after TAVR conferred an increased risk for mortality compared with mild or less TR at 1 year after TAVR. After TAVR, 63 patients (3.1%) were deemed potential candidates for TTVI. They had a 2-fold increased risk for mortality between 30 days and 1 year (HRadjusted: 1.93; 95% CI: 1.15-3.25) and a higher risk for persistent heart failure symptoms (adjusted risk ratio: 2.80; 95% CI: 1.78-4.40). CONCLUSIONS: A non-negligible proportion of patients were considered potential candidates for TTVI after TAVR and had impaired prognosis and persistently impaired functional status at 1 year. (SwissTAVI Registry; NCT01368250).


Assuntos
Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Humanos , Prognóstico , Estudos Prospectivos , Estudos Retrospectivos , Fatores de Risco , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento , Valva Tricúspide/diagnóstico por imagem , Valva Tricúspide/cirurgia
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