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1.
EuroIntervention ; 15(9): e736-e738, 2019 Oct 04.
Artigo em Inglês | MEDLINE | ID: mdl-31579008
3.
Eur Heart J ; 2019 Sep 11.
Artigo em Inglês | MEDLINE | ID: mdl-31511897

RESUMO

Tricuspid regurgitation (TR) is a frequent and complex problem, commonly combined with left-sided heart disease, such as mitral regurgitation. Significant TR is associated with increased mortality if left untreated or recurrent after therapy. Tricuspid regurgitation was historically often disregarded and remained undertreated. Surgery is currently the only Class I Guideline recommended therapy for TR, in the form of annuloplasty, leaflet repair, or valve replacement. As growing experience of transcatheter therapy in structural heart disease, many dedicated transcatheter tricuspid repair or replacement devices, which mimic well-established surgical techniques, are currently under development. Nevertheless, many aspects of TR are little understood, including the disease process, surgical or interventional risk stratification, and predictors of successful therapy. The optimal treatment timing and the choice of proper surgical or interventional technique for significant TR remain to be elucidated. In this context, we aim to highlight the current evidence, underline major controversial issues in this field and present a future roadmap for TR therapy.

5.
Artigo em Inglês | MEDLINE | ID: mdl-31518417

RESUMO

AIMS: The prognostic significance of cardiac magnetic resonance (CMR)-derived infarct characteristics has been demonstrated in ST-elevation myocardial infarction (STEMI) cohorts but is undefined in non-ST-elevation myocardial infarction (NSTEMI) patients. We aimed to investigate determinants and the long-term prognostic impact of CMR imaging-derived infarct characteristics in patients with NSTEMI. METHODS AND RESULTS: Infarct size (IS), myocardial salvage index (MSI), and microvascular obstruction were assessed using CMR imaging in 284 NSTEMI patients undergoing percutaneous coronary intervention (PCI) in three centres. CMR imaging was performed 3 [interquartile range (IQR) 2-4] days after admission. The primary clinical endpoint was defined as major adverse cardiac events during median follow-up of 4.4 (IQR 3.6-4.9) years. Median IS was 7.2% (IQR 2.2-13.7) of left ventricular (LV) myocardial mass (%LV) and MSI was 65.7 (IQR 39.3-84.9). Age (P ≤ 0.003), heart rate (P ≤ 0.02), the number of diseased coronary arteries (P ≤ 0.01), and Thrombolysis In Myocardial Infarction (TIMI) flow grade before PCI (P < 0.001) were independent predictors of IS and MSI. The primary endpoint occurred in 64 (22.5%) patients. CMR-derived infarct characteristics had no additional prognostic value beyond LV ejection fraction in multivariable analysis. CONCLUSION: In this prospective, multicentre NSTEMI cohort reperfused by PCI, age, heart rate, the number of diseased coronary arteries, and TIMI flow grade before PCI were independent predictors of IS and MSI assessed by CMR. However, in contrast to STEMI patients there was no additional long-term prognostic value of CMR-derived infarct characteristics over and above LV ejection fraction. CLINICALTRIALS.GOV: NCT03516578.

6.
JACC Cardiovasc Interv ; 12(16): 1606-1617, 2019 Aug 26.
Artigo em Inglês | MEDLINE | ID: mdl-31439340

RESUMO

OBJECTIVES: This study sought to evaluate SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, California) positioning using different strategies. BACKGROUND: Aortic valve-in-valve (ViV) is associated with high risk of elevated gradients. METHODS: S3 aortic ViV procedures in stented bioprostheses were studied. Transcatheter heart valve (THV) positioning was analyzed in a centralized core lab blinded to clinical outcomes. A combined endpoint of severely elevated mean gradient (≥30 mm Hg) or pacemaker need was established. Two positioning strategies were compared: central marker method and top of S3 method. Optimal final depth was defined as S3 depth ≤20%. RESULTS: A total of 113 patients met inclusion criteria and were analyzed (76.5 ± 9.7 years of age, 65.8% male, STS score 8 ± 7.6%). THVs had incomplete shortening in comparison to fully expanded valves (92 ± 3.4%), and expansion was more complete in optimal positioning cases compared with others (93.2 ± 2.7% vs. 91.5 ± 3.5%; p = 0.027). The central marker method demonstrated greater correlation with final implantation depth than the top of S3 method (R2 of 0.48 and 0.14; p < 0.001 and p = 0.001, respectively). The combined endpoint rate was 4.3% in the optimal (higher than 3 mm) implantation group, 12% in the intermediate group, and 50% in the low group (p < 0.001). There were no cases of THV embolization. In cases with central marker higher than 3 mm, 72.4% had optimal final depth. In those with central marker higher than 6 mm, 90% had optimal final depth. CONCLUSIONS: Optimal S3 positioning in aortic ViV is associated with better outcomes. Central marker positioning is more reliable than top of S3 positioning. Central marker bottom position should be 3 mm to 6 mm above the ring.

7.
JACC cardiovasc. interv. ; 12(16): 1606-1617, ago., 2019. ilus., graf., tab.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1022472

RESUMO

OBJECTIVES: This study sought to evaluate SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, California) positioning using different strategies. BACKGROUND: Aortic valve-in-valve (ViV) is associated with high risk of elevated gradients. METHODS: S3 aortic ViV procedures in stented bioprostheses were studied. Transcatheter heart valve (THV) positioning was analyzed in a centralized core lab blinded to clinical outcomes. A combined endpoint of severely elevated mean gradient ($30 mm Hg) or pacemaker need was established. Two positioning strategies were compared: central marker method and top of S3 method. Optimal final depth was defined as S3 depth #20%. RESULTS: A total of 113 patients met inclusion criteria and were analyzed (76.5 _ 9.7 years of age, 65.8% male, STS score 8 _ 7.6%). THVs had incomplete shortening in comparison to fully expanded valves (92 _ 3.4%), and expansion was more complete in optimal positioning cases compared with others (93.2 _ 2.7% vs. 91.5 _ 3.5%; p » 0.027). The central marker method demonstrated greater correlation with final implantation depth than the top of S3 method (R2 of 0.48 and 0.14; p < 0.001 and p » 0.001, respectively). The combined endpoint rate was 4.3% in the optimal (higher than 3 mm) implantation group, 12% in the intermediate group, and 50% in the low group (p < 0.001). There were no cases of THV embolization. In cases with central marker higher than 3 mm, 72.4% had optimal final depth. In those with central marker higher than 6 mm, 90% had optimal final depth. CONCLUSIONS: Optimal S3 positioning in aortic ViV is associated with better outcomes. Central marker positioning is more reliable than top of S3 positioning. Central marker bottom position should be 3 mm to 6 mm above the ring. (AU)


Assuntos
Marca-Passo Artificial , Substituição da Valva Aórtica Transcateter , Balão Intra-Aórtico
8.
Can J Cardiol ; 35(7): 866-874, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31292085

RESUMO

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is the gold standard for severe valvular aortic stenosis in patients at high/prohibitive surgical risk. This procedure has also been used in patients with previous mitral valve (MV) prostheses, with contrasting outcomes reported. The aim of this study is to describe procedural and early outcomes of patients with previous MV prostheses undergoing TAVR. METHODS: This is a retrospective registry of 154 patients with previous MV prostheses who underwent TAVR across high-volume medical centres at a mean of 11.7 ± 8.4 years after mitral surgery. RESULTS: Mean mitroaortic distance at computed tomography was 9.7 ± 4.8 mm. Procedural success was achieved in 150 (97.4%) patients, with reduction of aortic gradients (42.6 ± 14.2 to 10.0 ± 7.0 mm Hg; P < 0.001). Device success was achieved in 133 (86.3%) patients. MV prosthesis interference by the TAVR device was observed in 2 patients; in both, the mitroaortic distance was <5 mm, with 1 complicated by TAVR prosthesis embolization. Periprocedural complications included 4 (2.6%) cerebrovascular accidents, 10 (6.6%) major vascular complications, 22 (14.4%) severe bleedings, 1 (0.7%) myocardial infarction, and 5 (3.2%) in-hospital deaths (all cases cardiovascular or procedure related). At a median follow-up of 13.5 (interquartile range 1.0 to 36.0) months, 26 (16.9%) deaths occurred; 15 (9.7%) were cardiac related. Late fatal mitral prosthesis thromboses occurred in 2 patients. We recorded a case of fatal hemorrhagic stroke; hospital readmission was observed in 25 (16.2%) patients due to worsening heart failure. CONCLUSIONS: TAVR in patients with previous mitral prostheses appears to be safe and feasible, with good hemodynamic results at 30-day and at longer-term follow-up.

9.
Cardiol Ther ; 2019 Jul 27.
Artigo em Inglês | MEDLINE | ID: mdl-31350729

RESUMO

INTRODUCTION: Rotational atherectomy (RA) historically was contraindicated in patients with impaired left ventricular (LV) function due to inherent cardio-depressive effects. Contemporary RA practice is less aggressive than traditional RA and no longer withheld from patients with reduced ejection fraction (EF). The aim of this analysis is to explore the outcomes of rotational atherectomy (RA) in patients with reduced left ventricular ejection fraction (LVEF). METHODS: Patients undergoing RA (n = 644) were divided into three groups according to LVEF (severely reduced ≤ 35%, n = 82; moderately reduced 36-54%, n = 170; and preserved LVEF ≥ 55%, n = 392). RESULTS: Compared to patients with preserved LVEF, those with severely reduced LVEF had higher rates of angiographic failure (12.2 vs. 3.3%, p = 0.003) and in-hospital major adverse cardiac events (MACE: 9.8 vs. 2.3%, p = 0.004) driven by more peri-procedural myocardial infarction (MI: 6.1 vs. 1.5%, p = 0.049). In-hospital outcomes were similar between patients with preserved and moderately reduced LVEF. At 5-year follow-up, a stepwise increase in all-cause death was observed with lower LVEF (preserved: 15%, moderately reduced: 23%, severely reduced: 43%; p < 0.001). On the other hand, revascularization and MI rates at 5 years were not affected by LVEF. CONCLUSIONS: Compared to patients with preserved LVEF, those with severely reduced LVEF have worse acute outcomes after RA, whereas a moderate reduction of LVEF poses no additional acute hazard after RA. Up to 5 years, the extent of left ventricular dysfunction was associated with a stepwise increase in mortality.

10.
EuroIntervention ; 15(5): 420-426, 2019 Aug 29.
Artigo em Inglês | MEDLINE | ID: mdl-31147307

RESUMO

AIMS: Quantitative aortography using videodensitometry is a valuable tool for quantifying paravalvular regurgitation after TAVI, especially in the minimalist approach - without general anaesthesia. However, retrospective assessment of aortograms showed moderate feasibility of assessment. We sought to determine the prospective feasibility of quantitative aortography after a protocol of acquisition. METHODS AND RESULTS: This was a multicentre registry in Japan, Canada, the Netherlands and Germany including consecutive patients with Heart Team indication to undergo TAVI over a median period of 12 months. Operators performed final aortograms according to a pre-planned projection (either by CT or visually - Teng's rule). An independent core laboratory (Cardialysis) analysed all images for feasibility and for regurgitation assessment. From the four centres included in the present analysis, a total of 354 patients underwent TAVI following the acquisition protocol and all the aortograms were analysed by the core lab. The analyses were feasible in 95.5% (95% confidence interval [CI]: 93.2% to 97.5%) of the cases. This rate of analysable assessment was significantly higher than the feasibility in previous validation studies, such as in the RESPOND population (95.5% vs. 57.5%, p<0.0001). No differences were observed among different planning strategies (CT 96.5% vs. Teng's rule 93%, p=0.159; or Circle 98.5% vs. 3mensio 95.8% vs. Teng's rule 93%, p=0.247). CONCLUSIONS: ASSESS-REGURGE showed a high feasibility of assessment of regurgitation with quantitative aortography with protocoled acquisition. This may be of great importance for quantifying regurgitation in TAVI procedures (optimisation, guidance of post-dilatation), and in future clinical trials, in order to address sealing features of novel devices for TAVI objectively. ClinicalTrials.gov Identifier: NCT03644784.


Assuntos
Insuficiência da Valva Aórtica , Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Valva Aórtica , Insuficiência da Valva Aórtica/cirurgia , Aortografia , Humanos , Valor Preditivo dos Testes , Estudos Prospectivos , Sistema de Registros , Estudos Retrospectivos , Índice de Gravidade de Doença , Resultado do Tratamento
11.
Am J Cardiol ; 124(1): 78-84, 2019 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-31047652

RESUMO

Cardiovascular magnetic resonance (CMR) has demonstrated a high accuracy for evaluating the severity of aortic regurgitation (AR). However, scarce data exist on the impact of AR as evaluated by CMR on clinical outcomes following transcatheter aortic valve implantation (TAVI). The objective of this study was to evaluate the impact of AR as determined by CMR on clinical outcomes (mortality, heart failure [HF] hospitalization) post-TAVI. A total of 448 TAVI recipients from 2 centers (mean age: 80 ± 7 years, mean STS: 5.8 ± 5.4%) who survived the periprocedural period with no pacemaker implantation were included. A newer generation transcatheter valve system was used in 213 patients (48%). The CMR examination was performed at a median of 12 (IQR: 7 to 21) days post-TAVI. After a mean follow-up of 24 ± 19 months, a total of 94 patients (21%) had died and 72 patients (16%) had at least 1 hospitalization because of decompensated HF. The aortic regurgitation fraction (RF) as determined by CMR was an independent predictor of mortality (hazard ratio[HR]:1.06 for each increase of 10%, 95% confidence interval [CI]: 1.01 to 1.12, p = 0.03) and HF hospitalization (HR:1.15 for each increase of 10%, 95% CI:1.02 to 1.30, p = 0.02). The rate of moderate-severe CMR-AR defined as a RF ≥30% was 3%, and this was associated with an increased risk of mortality (HR: 2.63, 95% CI: 2.30 to 2.99, p <0.001) and HF hospitalization (HR: 2.96, 95% CI: 1.62 to 5.42, p ˂0.001). A stepwise increase in the risk of mortality and HF hospitalization was observed with an increase in AR severity, with a peak increase among patients with RF ≥30%. In conclusion, our results showed the clinical usefulness of evaluating AR severity by CMR post-TAVI. CMR would be particularly helpful in doubtful cases or those with discordances between echocardiography and clinical data.

12.
Int J Cardiol ; 288: 39-43, 2019 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-30948219

RESUMO

BACKGROUND: The management of patients with mitral regurgitation (MR) undergoing transcatheter aortic valve replacement (TAVR) is challenging. We sought to investigate the evolution and long-term prognostic impact of residual post-TAVR MR. METHODS: The severity of MR was assessed at baseline and at 30 days and six months post-TAVR. Left ventricular mass and volumes were assessed by magnetic resonance imaging at two weeks and six months post-TAVR. RESULTS: The study included 970 patients (age, 80.6 ±â€¯6.2 years; female, 53.2%; Society of Thoracic Surgeons score, 5.2 ±â€¯4.6). Moderate-severe MR at baseline improved at 30-day post-TAVR in 60% of cases, and TAVR with the Medtronic CoreValve (OR: 0.44 [0.23-0.86]) was associated with a lower likelihood of improvement. Further MR improvement continued beyond 30 days post-TAVR especially in patients with a significant improvement of left ventricular volume and mass. Stratified by the severity of MR at 30 days post-TAVR, the 5-year cumulative incidence of the composite of cardiovascular mortality or heart failure hospitalization was 37.5%, 40.0%, and 58.2% in patients with none-mild, moderate, and severe MR, respectively (log rank p < .001; adjusted hazard ratio of severe vs. none-mild MR: 4.83 [2.49-9.38]. CONCLUSIONS: MR improves in a majority of patients early after TAVR, and its evolution continues thereafter in line with reverse cardiac remodeling. Residual post-TAVR severe MR is associated with adverse long-term outcome. Therefore, intervention to treat severe MR persisting after TAVR should be considered by the heart team.

13.
JACC Cardiovasc Interv ; 12(7): 673-680, 2019 Apr 08.
Artigo em Inglês | MEDLINE | ID: mdl-30947942

RESUMO

OBJECTIVES: The purpose of this study is to report the 1-year results of the CENTERA-EU trial. BACKGROUND: The CENTERA transcatheter heart valve (THV) (Edwards Lifesciences, Irvine, California) is a low-profile (14-F eSheath compatible), self-expanding nitinol valve, with a motorized delivery system allowing for repositionability. The 30-day results of the CENTERA-EU trial demonstrated the short-term safety and effectiveness of the valve. METHODS: Implantations were completed in 23 centers in Europe, Australia, and New Zealand. Transfemoral access was used in all patients. Echocardiographic outcomes were adjudicated by a core laboratory at baseline, discharge, 30 days, 6 months, and 1 year. Major adverse clinical events were adjudicated by an independent clinical events committee. RESULTS: Between March 2015 and July 2016, 203 high-risk patients (age 82.7 ± 5.5 years, 67.5% women, 68.0% New York Heart Association functional class III or IV, Society of Thoracic Surgeons score 6.1 ± 4.2%) with severe, symptomatic aortic stenosis underwent transcatheter aortic valve replacement with the CENTERA THV. The primary endpoint of the study was 30-day mortality (1.0%). At 1 year, overall mortality was 9.1%, cardiovascular mortality was 4.6%, disabling stroke was 4.1%, new permanent pacemakers were implanted in 6.5% of patients at risk, and cardiac-related rehospitalization was 6.8%. Hemodynamic parameters were stable at 1 year, with a mean aortic valve gradient of 8.1 ± 4.7 mm Hg, a mean effective orifice area of 1.7 ± 0.42 cm2, and no incidences of severe or moderate aortic regurgitation. CONCLUSIONS: The CENTERA-EU trial demonstrated mid-term safety and effectiveness of the CENTERA THV, with low mortality, sustained improvements in hemodynamic performances, and low incidence of permanent pacemaker implantations in high-risk patients with symptomatic aortic stenosis. (Safety and Performance of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve [CENTERA-2]; NCT02458560).

14.
Catheter Cardiovasc Interv ; 93(6): 1116-1123, 2019 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-30773838

RESUMO

AIMS: Patients with bicuspid valves represent a challenging anatomical subgroup for transcatheter aortic valve implantation (TAVI). This analysis evaluated the clinical outcomes of the fully repositionable and retrievable Lotus Valve System in patients with bicuspid aortic valves enrolled in the RESPOND post-market registry. METHODS AND RESULTS: The prospective, open-label RESPOND study enrolled 1,014 patients at 41 centers in Europe, New Zealand, and Latin America, 31 (3.1%) of whom had bicuspid aortic valves. The mean age in the bicuspid patient cohort was 76.4 years, 64.5% were male, and the baseline STS score was 6.0 ± 10.2. Procedural success was 100%, with no cases of malpositioning, valve migration, embolization, or valve-in-valve. Repositioning was attempted in 10 cases (32.3%). There was one death (3.2%) and one stroke (3.2%) at 30-day follow-up. Mean AV gradient was reduced from 48.7 ± 17.0 mmHg at baseline to 11.8 ± 5.1 mmHg at hospital discharge (P < 0.001); mean effective orifice area (EOA) was increased from 0.6 ± 0.2 cm2 to 1.7 ± 0.4 cm2 (P < 0.001). There were no cases of moderate or severe paravalvular leak (PVL) adjudicated by the core laboratory; four subjects (13.8%) had mild PVL, 5 (17.2%) had trace PVL. The rate of pacemaker (PM) implantation for PM-naïve patients was 22.2% (6/27). CONCLUSIONS: Data from the RESPOND registry demonstrate good clinical and echocardiographic outcomes up to 1 year postimplantation in patients with bicuspid aortic valves using the repositionable Lotus Valve.

15.
Int J Cardiovasc Imaging ; 35(6): 1079-1087, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30771036

RESUMO

Data derived from several studies suggest a better survival in smokers with acute myocardial infarction, a phenomenon referred to as the 'smoker's paradox'. We aimed to investigate the association of smoking with cardiac magnetic resonance (CMR) imaging determined infarct severity and major adverse cardiac events (MACE) defined as the occurrence of death, reinfarction, and congestive heart failure at 12 months in patients with non-ST-elevation myocardial infarction (NSTEMI) reperfused by early percutaneous coronary intervention (PCI). In this multicenter, registry study 311 NSTEMI patients underwent CMR imaging 3 (interquartile range [IQR] 2-4) days after PCI. Myocardial salvage index (MSI), infarct size (IS), and microvascular obstruction (MVO) as well as MACE rate were compared according to admission smoking status. Approximately one-third of patients were current smokers (n = 122, 39%). Smokers were significantly younger and less likely to have hypertension as compared to non-smokers (all p < 0.05). The extent of MSI (63.2, IQR 28.9-85.4 vs. 65.6, IQR 42.2-82.9, p = 0.30), and IS (7.2, IQR 2.3-15.7%LV vs. 7.0, IQR 2.2-12.4%LV, p = 0.27) did not differ significantly between smokers and non-smokers. Despite similar prevalence of MVO, MVO (%LV) was higher in smokers compared to non-smokers (2.0, IQR 0.9-4.7%LV vs. 1.2, IQR 0.7-2.2%LV, p = 0.03). MACE rates at 12 months were comparable in smokers and non-smokers (5.7% vs. 7.4%, p = 0.65). In NSTEMI patients, smoking is neither associated with increased myocardial salvage nor less severe myocardial damage. Clinical outcome at 12 months was similar in smokers and non-smokers.Trial registration NCT03516578.


Assuntos
Imagem por Ressonância Magnética , Infarto do Miocárdio sem Supradesnível do Segmento ST/diagnóstico por imagem , Fumantes , Fumar/efeitos adversos , Fatores Etários , Idoso , Áustria , Causas de Morte , Comorbidade , Progressão da Doença , Feminino , Alemanha , Insuficiência Cardíaca/diagnóstico por imagem , Insuficiência Cardíaca/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio sem Supradesnível do Segmento ST/mortalidade , Infarto do Miocárdio sem Supradesnível do Segmento ST/cirurgia , Intervenção Coronária Percutânea , Valor Preditivo dos Testes , Estudos Prospectivos , Recidiva , Sistema de Registros , Medição de Risco , Fatores de Risco , Fumar/mortalidade , Fatores de Tempo , Resultado do Tratamento
16.
Eur Heart J ; 40(17): 1340-1341, 2019 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-30602014
17.
Eur Heart J ; 40(2): 180-186, 2019 Jan 07.
Artigo em Inglês | MEDLINE | ID: mdl-30596995

RESUMO

Aims: To assess the effect of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) with contemporary drug-eluting stents on the composite of cardiac death or myocardial infarction (MI) vs. medical therapy in patients with stable coronary lesions. Methods and results: We performed a systematic review and meta-analysis of individual patient data (IPD) of the three available randomized trials of contemporary FFR-guided PCI vs. medical therapy for patients with stable coronary lesions: FAME 2 (NCT01132495), DANAMI-3-PRIMULTI (NCT01960933), and Compare-Acute (NCT01399736). FAME 2 enrolled patients with stable coronary artery disease (CAD), while the other two focused on non-culprit lesions in stabilized patients after acute coronary syndrome. A total of 2400 subjects were recruited from 54 sites world-wide with 1056 randomly assigned to FFR-guided PCI and 1344 to medical therapy. The pre-specified primary outcome was a composite of cardiac death or MI. We included data from extended follow-ups for FAME 2 (up to 5.5 years follow-up) and DANAMI-3-PRIMULTI (up to 4.7 years follow-up). After a median follow-up of 35 months (interquartile range 12-60 months), a reduction in the composite of cardiac death or MI was observed with FFR-guided PCI as compared with medical therapy (hazard ratio 0.72, 95% confidence interval 0.54-0.96; P = 0.02). The difference between groups was driven by MI. Conclusion: In this IPD meta-analysis of the three available randomized controlled trials to date, FFR-guided PCI resulted in a reduction of the composite of cardiac death or MI compared with medical therapy, which was driven by a decreased risk of MI.

18.
JACC Cardiovasc Interv ; 12(1): 38-49, 2019 01 14.
Artigo em Inglês | MEDLINE | ID: mdl-30621976

RESUMO

OBJECTIVES: The authors sought to evaluate 1-year clinical outcomes with the Lotus valve (Boston Scientific, Marlborough, Massachusetts) in a large international, multicenter prospective registry including patients eligible for transcatheter aortic valve replacement (TAVR) based on heart team consensus. BACKGROUND: TAVR is a safe and effective treatment for severe aortic valve stenosis; however, limited data are available on TAVR with the repositionable and fully retrievable Lotus valve in unrestricted contemporary clinical practice. METHODS: The RESPOND (Repositionable Lotus Valve System-Post-Market Evaluation of Real World Clinical Outcomes) study enrolled 1,014 patients; 996 patients were implanted with the Lotus valve (mean age 80.8 years, 50.8% female, mean STS score 6.0 ± 6.9%). The primary endpoint was all-cause mortality in the intent-to-treat population at 30 days and 1 year. An Extension cohort of 50 patients was treated with the Lotus valve with Depth Guard including a modified delivery system. Mortality and stroke were independently adjudicated. An independent core laboratory assessed echocardiographic data. RESULTS: One-year clinical follow-up was available for 99.9% of Lotus valve-treated patients. At 1 year, the all-cause mortality rate was 11.7% and 4.1% of patients had experienced a disabling stroke. The permanent pacemaker implantation rate was 32% (37% among pacemaker-naive patients). Echocardiographic data at 1 year were available for core laboratory assessment in 62.6% of patients. Paravalvular leak was absent or trace in 94.5%, mild in 5.1%, and moderate in 0.4% of patients. Data from the Extension cohort confirmed good clinical outcomes at 30 days with an 18% permanent pacemaker rate (20% among pacemaker-naive patients). CONCLUSIONS: One-year outcomes from the RESPOND study confirm the safety and efficacy of the Lotus valve when used in routine clinical practice. (Repositionable Lotus Valve System-Post-Market Evaluation of Real World Clinical Outcomes [RESPOND]; NCT02031302).

20.
Clin Res Cardiol ; 108(7): 763-771, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30552511

RESUMO

BACKGROUND: Current trials and registries of transcatheter valve implantation (TAVI) mostly include patients older than 75 years. Little is known about younger patients who undergo this treatment. We investigated comorbidities among patients < 75 years old who underwent TAVI in the SAPIEN 3™ European post-approval SOURCE 3 Registry, and analysed outcomes at 30 days and 1 year. METHODS AND RESULTS: Three age groups of patients were analysed for outcomes and characteristics: < 75 (n = 235), 75-80 (n = 391) and ≥ 80 years (n = 1320). Overall, the mean age was 81.6 ± 6.7 years; transfemoral access was used in 87.1% of patients treated with SAPIEN 3 transcatheter heart valves. The mean logistic EuroSCORE increased according to age group (12.6%, 17.3% and 19.7%, respectively, p < 0.001). Younger patients had a higher incidence of comorbidities, particularly those not included in surgical risk score assessment tools, e.g., severe liver disease, previous radiation therapy, and porcelain aorta. Mortality rates were similar between age groups at 30 days (1.7%, 2.0% and 2.3%, respectively, p = 0.79) and 1 year (14.2%, 9.3% and 13.3%, respectively, p = 0.08). However, sudden cardiac death rates were higher in the < 75 years age group compared with the ≥ 85 years age group (20.7% vs. 4.8%, p = 0.010). CONCLUSIONS: In current TAVI practice, patients younger than 75 years are a minority (12%). Despite younger age and lower surgical risk scores, this cohort was characterized by comorbidities not accounted for by traditional surgical risk scores. More data are needed for this age group to guide the appropriate decision between surgery and TAVI. CLINICALTRIAL. GOV NUMBER: NCT02698956.

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