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1.
EuroIntervention ; 15(14): 1223-1224, 2020 Feb 20.
Artigo em Inglês | MEDLINE | ID: mdl-32044730
2.
Artigo em Inglês | MEDLINE | ID: mdl-31977142

RESUMO

BACKGROUND: The prevalence of both chronic kidney disease (CKD) and aortic stenosis (AS) increase with age. Although baseline CKD is frequent in patients undergoing transcatheter aortic valve replacement (TAVR), its significance among women is largely unknown. METHODS: Women's INternational Transcatheter Aortic Valve Implantation (WIN-TAVI) is a multinational, prospective registry of women undergoing TAVR for severe AS. We included patients with available baseline estimated glomerular filtration rate (eGFR) and completed 1-year follow-up. Patients were categorized into three groups based on their eGFR: No CKD (normal kidney function to stage 2 CKD: eGFR ≥60 ml/min/1.73 m2 ); (b) mild CKD (stage 3a CKD: eGFR = 45-59 ml/min/1.73 m2 ); and (c) moderate/severe CKD (stage ≥3b CKD: eGFR <45 ml/min/1.73 m2 ). All events were adjudicated according to the Valve Academic Research Consortium (VARC)-2 criteria. RESULT: Out of 852 women undergoing TAVR, 326 (38.3%) had no CKD, 225 (26.4%) had mild CKD, and 301 (35.3%) had moderate/severe CKD. Women with higher stage of CKD at baseline were more likely to have a history of hypertension, diabetes, atrial fibrillation, anemia, chronic lung disease, hemodialysis, prior percutaneous coronary intervention, and pacemaker implantation. After multivariate adjustment, moderate/severe CKD was associated with a greater risk of 1-year VARC-2 safety endpoints [hazard ratio (HR) 1.68, 95% confidence interval (CI): 1.10-2.60], all-cause death (HR 2.00, 95% CI: 1.03-3.90), and composite of death, myocardial infarction, stroke or life-threatening bleeding (HR 1.70, 95% CI: 1.04-2.76). There were no differences in 30-day and 1-year VARC-2 efficacy and 30-day VARC-2 safety outcomes. CONCLUSION: CKD is associated with substantial and independent risk for mortality and morbidity at 1-year follow-up in women undergoing TAVR.

3.
Artigo em Inglês | MEDLINE | ID: mdl-31943717

RESUMO

BACKGROUND/OBJECTIVES: Clinicians use validated scores to risk-stratify patients undergoing transcatheter aortic valve replacement (TAVR). However, evaluation by the Heart Team often deems patients to be at higher risk than their formal scores suggest. We sought to assess clinical outcomes of TAVR patients defined as high-risk by the Heart Team's assessment versus the patient's logistic EuroSCORE (LES). METHODS: The BRAVO-3 trial randomized patients at high risk (LES ≥ 18, or deemed inoperable by the Heart Team) to TAVR with periprocedural anticoagulation with unfractionated heparin versus bivalirudin. Endpoints included net adverse cardiac events (NACE: the composite of all-cause mortality, MI, stroke, or bleeding), major adverse cardiovascular events (MACE: death, MI, or stroke), the individual components of MACE, major vascular complications, BARC ≥ 3b bleeding and VARC life-threatening bleeding at 30 days. We compared patients deemed high-risk based on LES ≥ 18 versus high-risk by the Heart Team despite lower LES. RESULTS: A total of 467/800 (58.4%) patients were deemed high-risk by the Heart Team despite LES < 18. After multivariable analysis, there were no differences in the odds of endpoints between groups (NACE, ORLES≥18 : 1.32, 95% CI 0.86-2.02, p = .21; MACE, ORLES≥18 : 1.27, 95% CI 0.72-2.25, p = .41; major vascular complications, ORLES≥18 : 0.97, 95% CI 0.65-1.44, p = .88; BARC ≥3b, ORLES≥18 : 1.38, 95% CI 0.82-2.33, p = .23; and VARC life-threatening bleeding, ORLES≥18 : 0.99, 95% CI 0.69-1.41, p = .95). CONCLUSION: Patients undergoing TAVR and labeled high-risk by LES ≥ 18 or Heart Team assessment despite LES < 18 have comparable short-term outcomes. Assignment of high-risk status to over 50% of patients is attributable to Heart Team's clinical assessment.

4.
Am J Cardiol ; 125(3): 441-448, 2020 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-31813530

RESUMO

We sought to analyze outcomes of women receiving balloon-expandable valves (BEV) or self-expanding valves (SEV) in contemporary transcatheter aortic valve implantation (TAVI). WIN TAVI (Women's INternational Transcatheter Aortic Valve Implantation) is the first all-female TAVI registry to study the safety and performance of TAVI in women. We compared women treated with BEV (n = 408, 46.9%) versus those treated with SEV (n = 461, 53.1%). The primary efficacy end point was the Valve Academic Research Consortium-2 (VARC-2) composite of 1-year all-cause death, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction. Women receiving SEV had higher surgical risk scores, higher rate of previous stroke and pulmonary hypertension whereas women receiving BEV were more frequently denied surgical valve replacement due to frailty. BEV patients were less likely to require post-dilation and had significantly lower rates of residual aortic regurgitation grade ≥2 (9.8% vs 4.7%, p = 0.007). At 1 year, the crude incidence and adjusted risk of the primary VARC-2 efficacy end point was similar between groups (17.1% with SEV and 14.3% with BEV, p = 0.25; hazards ratio 1.09, 95% confidence interval 0.68 to 1.75). Conversely the crude rate and adjusted risk of new pacemaker implantation was higher with SEV than BEV (15% vs 8.6%, p = 0.001; hazards ratio 1.97, 95% confidence interval 1.13 to 3.43). A subanalysis on new generation valves showed no difference in the need for pacemaker implantation between the 2 devices (10.1% vs 8.0%, p = 0.56). In conclusion, in contemporary TAVI, SEV are used more frequently in women with greater co-morbidities. While there were no differences in unadjusted and adjusted risk of 1-year primary efficacy end point between the valve types, there was a greater need for permanent pacemakers after SEV implantation.

5.
Int J Cardiol ; 300: 60-65, 2020 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-31718825

RESUMO

BACKGROUND: The aim of this study was to compare the 12-month clinical outcomes of patients treated with Magmaris or Orsiro. Second generation drug-eluting absorbable metal scaffold Magmaris (Dreams 2G) has proved to be safe and effective in the BIOSOLVE-II study. Similarly, biodegradable polymer sirolimus-eluting stent, Orsiro has shown notable clinical results even in all-comer populations. METHODS: Magmaris group patients were taken from the BIOSOLVE-II and BIOSOLVE-III trials, while the patients from Orsiro group were enrolled in BIOFLOW-II trial. The primary outcome was explored using a time-to-event assessment of the unadjusted clinical outcomes for target lesion failure (TLF) at 12 months, followed by a multivariate analysis adjusting for all the significantly different covariates between the groups. RESULTS: The study population consisted of 482 patients (521 lesions), 184 patients (189 lesions) in Magmaris group and 298 patients (332 lesions) in Orsiro group. The mean age was 65.5 ±â€¯10.8 and 62.7 ±â€¯10.4 years in Magmaris and Orsiro groups, respectively (p = 0.005). Magmaris and Orsiro unadjusted TLF rates were 6.0 and 6.4% with no significant difference between the groups (p = 0.869). In the multivariate analysis, there were no meaningful differences between Magmaris and Orsiro groups. Finally, none of the groups presented device thrombosis cases at 12 months. CONCLUSION: At 12 months there were no significant differences between Magmaris and Orsiro groups neither in the unadjusted assessment nor in the multivariate analysis for target lesion failure. These results should be taken as hypothesis generating and may warrant a head to head comparison on a randomized fashion.

6.
Circulation ; 141(4): 243-259, 2020 Jan 28.
Artigo em Inglês | MEDLINE | ID: mdl-31736356

RESUMO

BACKGROUND: No randomized study powered to compare balloon expandable (BE) with self expanding (SE) transcatheter heart valves (THVs) on individual end points after transcatheter aortic valve replacement has been conducted to date. METHODS: From January 2013 to December 2015, the FRANCE-TAVI nationwide registry (Registry of Aortic Valve Bioprostheses Established by Catheter) included 12 141 patients undergoing BE-THV (Edwards, n=8038) or SE-THV (Medtronic, n=4103) for treatment of native aortic stenosis. Long term mortality status was available in all patients (median 20 months; interquartile range, 14 to 30). Patients treated with BE-THV (n=3910) were successfully matched 1:1 with 3910 patients treated with SE-THV by using propensity score (25 clinical, anatomical, and procedural variables) and by date of the procedure (within 3 months). The first coprimary outcome was ≥ moderate occurrence of paravalvular regurgitation or in-hospital mortality, or both. The second coprimary outcome was 2-year all-cause mortality. RESULTS: In propensity-matched analyses, the incidence of the first coprimary outcome was higher with SE-THV (19.8%) compared with BE-THV (11.9%; relative risk, 1.68 [95% CI, 1.46-1.91]; P<0.0001). Each component of the outcome was also higher in patients receiving SE-THV: ≥ moderate paravalvular regurgitation (15.5% versus 8.3%; relative risk, 1.90 [95% CI, 1.63-2.22]; P<0.0001) and in hospital mortality (5.6% versus 4.2%; relative risk, 1.34 [95% CI, 1.07-1.66]; P=0.01). During follow up, all cause mortality occurred in 899 patients treated with SE-THV (2-year mortality, 29.8%) and in 801 patients treated with BE-THV (2-year mortality, 26.6%; hazard ratio, 1.17 [95% CI, 1.06-1.29]; P=0.003). Similar results were found using inverse probability of treatment weighting using propensity score analysis. CONCLUSION: The present study suggests that use of SE-THV was associated with a higher risk of paravalvular regurgitation and higher in-hospital and 2-year mortality compared with use of BE-THV. These data strongly support the need for a randomized trial sufficiently powered to compare the latest generation of SE-THV and BE-THV. CLINICAL TRIAL REGISTRATION: https://www.clinicaltrials.gov. Unique identifier: NCT01777828.

7.
JACC Cardiovasc Interv ; 12(24): 2449-2459, 2019 Dec 23.
Artigo em Inglês | MEDLINE | ID: mdl-31857014

RESUMO

OBJECTIVES: This study investigated whether left ventricular (LV) stimulation via a guidewire-reduced procedure duration while maintaining efficacy and safety compared with standard right ventricular (RV) stimulation. BACKGROUND: Rapid ventricular pacing is necessary to ensure cardiac standstill during transcatheter aortic valve replacement (TAVR). METHODS: This is a prospective, multicenter, single-blinded, superiority, randomized controlled trial. Patients undergoing transfemoral TAVR with a SAPIEN valve (Edwards Lifesciences, Irvine, California) were allocated to LV or RV stimulation. The primary endpoint was procedure duration. Secondary endpoints included efficacy, safety, and cost at 30 days. RESULTS: Between May 2017 and May 2018, 307 patients were randomized, but 4 were excluded because they did not receive the intended treatment: 303 patients were analyzed in the LV (n = 151) or RV (n = 152) stimulation groups. Mean procedure duration was significantly shorter in the LV stimulation group (48.4 ± 16.9 min vs. 55.6 ± 26.9 min; p = 0.0013), with a difference of -0.12 (95% confidence interval: -0.20 to -0.05) in the log-transformed procedure duration (p = 0.0012). Effective stimulation was similar in the LV and RV stimulation groups: 124 (84.9%) versus 128 (87.1%) (p = 0.60). Safety of stimulation was also similar in the LV and RV stimulation groups: procedural success occurred in 151 (100%) versus 151 (99.3%) patients (p = 0.99); 30-day MACE-TAVR (major adverse cardiovascular event-transcatheter aortic valve replacement) occurred in 21 (13.9%) versus 26 (17.1%) patients (p = 0.44); fluoroscopy time (min) was lower in the LV stimulation group (13.48 ± 5.98 vs. 14.60 ± 5.59; p = 0.02), as was cost (€18,807 ± 1,318 vs. €19,437 ± 2,318; p = 0.001). CONCLUSIONS: Compared with RV stimulation, LV stimulation during TAVR was associated with significantly reduced procedure duration, fluoroscopy time, and cost, with similar efficacy and safety. (Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVR [EASY TAVI]; NCT02781896).

8.
J Am Coll Cardiol ; 74(22): 2728-2739, 2019 Dec 03.
Artigo em Inglês | MEDLINE | ID: mdl-31779788

RESUMO

BACKGROUND: Femoral access is the gold standard for transcatheter aortic valve replacement (TAVR). Guidelines recommend reconsidering surgery when this access is not feasible. However, alternative peripheral accesses exist, although they have not been accurately compared with femoral access. OBJECTIVES: This study compared nonfemoral peripheral (n-FP) TAVR with femoral TAVR. METHODS: Using the data from the national prospective French registry (FRANCE TAVI [French Transcatheter Aortic Valve Implantation]), this study compared the characteristics and outcomes of TAVR procedures according to whether they were performed through a femoral or a n-FP access, using a pre-specified propensity score-based matching between groups. Subanalysis during 2 study periods (2013 to 2015 and 2016 to 2017) and among low/intermediate-low and intermediate-high/high volume centers were performed. RESULTS: Among 21,611 patients, 19,995 (92.5%) underwent femoral TAVR and 1,616 (7.5%) underwent n-FP TAVR (transcarotid, n = 914 or trans-subclavian, n = 702). Patients in the n-FP access group had more severe disease (mean logistic EuroSCORE 19.95 vs. 16.95; p < 0.001), with a higher rate of peripheral vascular disease, known coronary artery disease, chronic pulmonary disease, and renal failure. After matching, there was no difference in the rate of post-procedural death and complications according to access site, except for a 2-fold lower rate of major vascular complications (odds ratio: 0.45; 95% confidence interval: 0.21 to 0.93; p = 0.032) and unplanned vascular repairs (odds ratio: 0.41; 95% confidence interval: 0.29 to 0.59; p < 0.001) in those who underwent n-FP access. The comparison of outcomes provided similar results during the second study period and in intermediate-high/high volume centers. CONCLUSIONS: n-FP TAVR is associated with similar outcomes compared with femoral peripheral TAVR, except for a 2-fold lower rate of major vascular complications and unplanned vascular repairs. n-FP TAVR may be favored over surgery in patients who are deemed ineligible for femoral TAVR and may be a safe alternative when femoral access risk is considered too high.

9.
Artigo em Inglês | MEDLINE | ID: mdl-31778163

RESUMO

OBJECTIVES: Transcatheter aortic valve implantation with a transaortic approach (TAo-TAVI) is an alternative to transapical or femoral access. We studied the procedural and midterm efficacy and safety of TAo-TAVI with Edwards Sapien XT and Medtronic CoreValve devices. METHODS: Among 901 patients receiving TAVI since 2006, 265 consecutive patients underwent TAo-TAVI between January 2011 and September 2014. Procedural and midterm results were evaluated according to Valve Academic Research Consortium-2 criteria. RESULTS: The mean age was 83 ± 5 years. Sapien XT and CoreValve were used in 191 (72.1%) and 74 (27.9%) patients, respectively. Full sternotomy made elective concomitant off-pump coronary artery bypass grafting possible in 38 patients (14.3%) with severe coronary artery disease unsuitable for percutaneous coronary intervention. The device success rate was 95.5%. Postprocedural paravalvular leak ≥2/4 was observed in 16 patients (6.4%). Emergency open chest surgery was required in 10 patients (3.8%) (3 aortic dissections, 3 valve embolizations, 2 LMCA occlusions, 1 aortic annulus rupture and 1 aortic rupture). Cerebrovascular accidents occurred in 3 patients (1.1%). Transfusions ≥4 units were required in 36 patients (13.6%). New pacemakers were implanted in 26 patients (9.8%). Thirty-day and 1-year mortality were 8.7% and 16.2%, respectively. Mean follow-up duration was 24 ± 6 months. At 3 years, freedom from all-cause death was 80% ± 4%. New York Heart Association class

10.
EuroIntervention ; 2019 Sep 24.
Artigo em Inglês | MEDLINE | ID: mdl-31543500

RESUMO

AIMS: To demonstrate the noninferiority of the BiOSS LIM C sirolimus-eluting cobalt-chromium bifurcation dedicated stent against the Xience stent regarding patients oriented composite endpoint (POCE) at 12 months among patients with left main coronary artery disease (LMCA). METHODS AND RESULTS: The POLBOS LM study is a single-arm prospective multi-centre study enrolling 260 patients (SYNTAX score ≤32) with pre-specified performance goal based on the results of the EXCEL trial with contemporary percutaneous coronary intervention (PCI) for LMCA disease. Patient enrollment will comply with objective inclusion criteria of diameter stenosis ≥50% in LMCA based on off-line quantitative coronary angiography (QCA) analyzed by an independent core laboratory using dedicated-bifurcation QCA software. The BiOSS LIM C is used for the treatment of LMCA disease with the specific technical classification for the BiOSS LIM (modified MADS classification) and the stent implantation is optimized by using pre-specified intravascular ultrasound criteria. Primary endpoint is POCE (a composite of all-cause death, stroke, any myocardial infarction, and any revascularization) at 12 months. CONCLUSION: The POLBOS LM study will indicate the efficacy of BiOSS LIM C stent with contemporary PCI for distal left main bifurcation lesions in comparison with the XIENCE stent from the recent EXCEL trial, as a performance index.

11.
Circ Cardiovasc Interv ; 12(10): e008434, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31553205

RESUMO

BACKGROUND: The feasibility of intravascular lithotripsy (IVL) for modification of severe coronary artery calcification (CAC) was demonstrated in the Disrupt CAD I study (Disrupt Coronary Artery Disease). We next sought to confirm the safety and effectiveness of IVL for these lesions. METHODS: The Disrupt CAD II study was a prospective multicenter, single-arm post-approval study conducted at 15 hospitals in 9 countries. Patients with severe CAC with a clinical indication for revascularization underwent vessel preparation for stent implantation with IVL. The primary end point was in-hospital major adverse cardiac events (cardiac death, myocardial infarction, or target vessel revascularization). An optical coherence tomography substudy was performed to evaluate the mechanism of action of IVL, quantifying CAC characteristics and calcium plaque fracture. Independent core laboratories adjudicated angiography and optical coherence tomography, and an independent clinical events committee adjudicated major adverse cardiac events. RESULTS: Between May 2018 and March 2019, 120 patients were enrolled. Severe CAC was present in 94.2% of lesions. Successful delivery and use of the IVL catheter was achieved in all patients. The post-IVL angiographic acute luminal gain was 0.83±0.47 mm, and residual stenosis was 32.7±10.4%, which further decreased to 7.8±7.1% after drug-eluting stent implantation. The primary end point occurred in 5.8% of patients, consisting of 7 non-Q-wave myocardial infarctions. There was no procedural abrupt closure, slow or no reflow, or perforations. In 47 patients with post-percutaneous coronary intervention optical coherence tomography, calcium fracture was identified in 78.7% of lesions with 3.4±2.6 fractures per lesion, measuring 5.5±5.0 mm in length. CONCLUSIONS: In patients with severe CAC who require coronary revascularization, IVL was safely performed with high procedural success and minimal complications and resulted in substantial calcific plaque fracture in most lesions. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03328949.

12.
Eur J Heart Fail ; 21(12): 1619-1627, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31476260

RESUMO

AIMS: The MITRA-FR trial showed that among symptomatic patients with severe secondary mitral regurgitation, percutaneous repair did not reduce the risk of death or hospitalization for heart failure at 12 months compared with guideline-directed medical treatment alone. We report the 24-month outcome from this trial. METHODS AND RESULTS: At 37 centres, we randomly assigned 304 symptomatic heart failure patients with severe secondary mitral regurgitation (effective regurgitant orifice area >20 mm2 or regurgitant volume >30 mL), and left ventricular ejection fraction between 15% and 40% to undergo percutaneous valve repair plus medical treatment (intervention group, n = 152) or medical treatment alone (control group, n = 152). The primary efficacy outcome was the composite of all-cause death and unplanned hospitalization for heart failure at 12 months. At 24 months, all-cause death and unplanned hospitalization for heart failure occurred in 63.8% of patients (97/152) in the intervention group and 67.1% (102/152) in the control group [hazard ratio (HR) 1.01, 95% confidence interval (CI) 0.77-1.34]. All-cause mortality occurred in 34.9% of patients (53/152) in the intervention group and 34.2% (52/152) in the control group (HR 1.02, 95% CI 0.70-1.50). Unplanned hospitalization for heart failure occurred in 55.9% of patients (85/152) in the intervention group and 61.8% (94/152) in the control group (HR 0.97, 95% CI 0.72-1.30). CONCLUSIONS: In patients with severe secondary mitral regurgitation, percutaneous repair added to medical treatment did not significantly reduce the risk of death or hospitalization for heart failure at 2 years compared with medical treatment alone.

13.
Int J Cardiol ; 296: 98-102, 2019 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-31455517

RESUMO

BACKGROUND: Predictors of heart failure (HF) hospitalization after transcatheter aortic valve implantation (TAVI) are not well defined. CAPRI is a score for predicting 1-year post-TAVI cardiovascular and all-cause mortality. The aim of the present study is to assess the prognostic significance of the CAPRI score for HF hospitalization 1 year after TAVI. METHODS AND RESULTS: CAPRI-HF is an ancillary study of the C4CAPRI trial, analyzing 409 consecutive patients treated by TAVI. The primary outcome was hospitalization for HF during the first year post-intervention. The prognostic value of the CAPRI score was assessed by multivariable analysis adjusted for diabetes, atrial fibrillation, vascular route, pacemaker implantation, post-TAVI aortic regurgitation, transfusion and pulmonary artery systolic pressure. A subanalysis focused on patients with low-gradient aortic stenosis (LGAS). At 1 year, HF hospitalization occurred in 78 (19.9%) patients. Patients with HF were more prone to have diabetes, atrial fibrillation, renal dysfunction, lower mean aortic gradient, higher logistic EuroSCORE and higher CAPRI score (p < .05 for all associations). In the multivariable analysis, CAPRI score was the sole predictor of HF: hazard ratio (HR) for each 0.1 CAPRI score increase was 1.065, 95% confidence interval (CI) 1.021-1.110. This was confirmed when adjusted for EuroSCORE: HR 1.066, 95% CI 1.024-1.110. The predictive power of the CAPRI score increased for LGAS: HR 1.098, 95% CI 1.028-1.172. CONCLUSIONS: CAPRI score helps predict HF post-TAVI. Including the score in the decision-making process may help selecting candidates for TAVI and identifying patients who need close monitoring post-procedure.

14.
Eur J Cardiothorac Surg ; 56(6): 1140-1146, 2019 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-31365061

RESUMO

OBJECTIVES: The transcarotid (TC) approach for transcatheter aortic valve implantation (TAVI) is potentially an optimal alternative to the transfemoral (TF) approach. Our goal was to compare the safety and efficacy of TC- and TF-TAVI. METHODS: Patients who underwent TF-TAVI or TC-TAVI in the prospectively collected FRANCE TAVI registry between January 2013 and December 2015 were compared. Propensity score inverse probability weighting methods were employed to minimize the impact of bias related to non-random treatment assignment. RESULTS: Of the 11 033 patients included in the current study, 10 598 (96%) underwent a TF-TAVI and 435 (4.1%) had a TC-TAVI. Patients in the TC-TAVI access group presented with a higher risk profile but were significantly younger. There were no differences in the perioperative and 2-year mortality rates after adjustment [odds ratio (OR) 1.02, 95% confidence interval (CI) 0.62-1.68; P = 0.99 and hazard ratio 1.03, 95% CI 0.7-1.35; P = 0.83). TC-TAVI was associated with a significant risk of stroke (OR 2.42, 95% CI 2.01-2.92; P < 0.001), ST-elevation myocardial infarction (OR 7.32, 95% CI 3.87-13.87; P < 0.001), infections (OR 2.36, 95% CI 2.04-2.71; P < 0.001), bleeding (OR 2.01, 95% CI 1.76-2.29; P < 0.001), renal failure (OR 2.23, 95% CI 1.90-2.60; P < 0.001) and need for dialysis (OR 2.36, 95% CI 2.01-2.76, P < 0.001). Conversely, TC-TAVI was not confirmed as a risk factor for pacemaker implantation after adjustment (OR 1.05, 95% CI 0.96-1.15; P < 0.28) and was a protective factor for vascular complications (OR 0.37, 95% CI 0.32-0.43; P < 0.001). CONCLUSIONS: TC-TAVI is a safe procedure compared to TF-TAVI, although it holds an increased risk of perioperative complications. It should be considered in case of non-femoral peripheral access as the second access choice, to increase the overall safety of TAVI procedures.

15.
Int J Cardiol ; 296: 32-37, 2019 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-31256993

RESUMO

AIMS: To investigate the impact of transcatheter aortic valve replacement (TAVR) without preliminary balloon aortic valvuloplasty (pre-BAV) on periprocedural outcomes in a large, real-world registry. METHODS AND RESULTS: The SOURCE 3 registry was an observational, multi-center, single-arm study of patients with severe, symptomatic aortic stenosis at high surgical risk treated with the SAPIEN 3 transcatheter heart valve (THV). Procedural and 30-day outcomes were compared between two groups of 772 patients each (retrospectively matched) with or without pre-BAV. All baseline clinical, echocardiographic, and anatomical valve characteristics were comparable between groups except for Society of Thoracic Surgeons (STS) score, which was lower in the direct TAVR group (6.0 ±â€¯5.9 vs 7.8 ±â€¯8.3; p = 0.003). In the direct TAVR group, there were less post-dilatations (8.1% vs. 13.1%, p = 0.002), shorter procedural time (70.9 ±â€¯39.8 min vs 73.0 ±â€¯32.2 min, p = 0.033) and fluoroscopy time (13.4 ±â€¯7.0 min vs 14.9 ±â€¯7.4 min, p < 0.001). Other procedural outcomes and echocardiographic variables at 30 days did not differ significantly between the two groups: safety endpoint (10.4% with pre-BAV vs 13.5% with direct TAVR, p = 0.059), mortality (2.1% vs 2.3%, p = 0.730), disabling strokes (0.4% vs 0.5%, p = 0.704), and moderate to severe paravalvular leak (PVL) (3.2% vs 2.2%, p = 0.40). Unexpectedly, new permanent pacemaker implantation and life-threatening bleeds were less frequently observed with pre-BAV group than with direct TAVR (10.4% vs 13.9%, p = 0.032 and 3.5% vs 6.5%, p = 0.007, respectively). CONCLUSION: In this large TAVR dataset, direct implantation of the SAPIEN 3 THV without pre-BAV was feasible and safe and resulted in shorter procedures, without impact on 30-day prosthesis function and PVL.

16.
Open Heart ; 6(1): e001008, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31218003

RESUMO

Background: Patients with severe aortic stenosis (AS) have a reduced life expectancy and quality of life (QoL), owing to advanced age and the presence of multiple comorbidities. Currently, there is no AS-specific QoL measurement tool, which prevents an accurate assessment of how this chronic condition and its treatment affect patients. The Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) was developed in order to address this deficiency. Methods: The present trial protocol was designed to enable validation of the TASQ, which has been produced in five languages (English, French, German, Italian and Spanish) to increase usability. Patients with severe AS who are undergoing surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) will be asked to complete the TASQ and, for comparative purposes, the Kansas City Cardiomyopathy Questionnaire and the general health-related QoL Short Form-12 questionnaire. The questionnaires will be completed prior to the intervention, at discharge, as well as at 30 days and 3 months follow-up. A total of 290 patients will be recruited across one Canadian and nine European centres. Overall, the protocol validation aims to include 120 patients undergoing transfemoral TAVI (TF-TAVI), 120 undergoing SAVR and up to 50 being treated medically. The primary objective of the registry is to validate the TASQ in five different languages. The secondary objective is to assess the utility of the TASQ for assessing differences in QoL outcome between patients undergoing TF-TAVI, SAVR or medical management for their AS. Discussion: Validation and roll-out of the TASQ will enable clinicians to capture an accurate assessment of how AS and its management affects the QoL of patients and will help them to determine the most appropriate treatment strategy for individual patients. Trial registration number: NCT03186339.

17.
Curr Opin Insect Sci ; 34: 48-54, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31247417

RESUMO

Behavioural resistance to insecticides may be an important factor restraining the efficacy of vector control against mosquito-transmitted diseases. However, our understanding of the mechanisms underlying such behavioural resistance remains sparse. In this review, we focus on the behavioural adaptations of mosquito vectors in response to the use of insecticides and provide a general framework for guiding future investigations. We present our review of vector behaviour in the field and a conceptual classification of behavioural adaptations to insecticides. We emphasise that behavioural adaptations can result from constitutive or induced (i.e. phenotypically plastic) traits. Lastly, we identify gaps in knowledge limiting a better understanding of how mosquito behavioural adaptations may affect the fight against vector-borne diseases.

18.
Int J Cardiol ; 288: 29-33, 2019 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-31047703

RESUMO

BACKGROUND: Conflicting results have been reported regarding sex differences in percutaneous coronary intervention (PCI), but their potential influence on clinical outcomes after chronic total coronary occlusion (CTO) PCI remains unknown. We aimed to identify sex-related differences in long-term clinical outcomes after CTO PCI. METHODS AND RESULTS: All consecutive patients undergoing CTO PCI between 2004 and 2012 were included in a prospective registry. Baseline, procedural characteristics and clinical outcomes were compared according to sex. Out of 1343 patients, 194 were female (14.4%). Women were older (68.5 ±â€¯9.9 vs 62.3 ±â€¯10.8 years, p < 0.001), more frequently diabetic (33.5% vs 26.4%, p = 0.026) and hypertensive (70.1% vs 57.4%, p < 0,001), whereas males were more frequently smokers (28.5% vs 15.5%, p < 0.001). J-CTO score was similar between both sexes (1.59 ±â€¯0.91 vs 1.51 ±â€¯0.88). The procedural success rate was also similar in men and women (74.0% vs 77.3%, respectively). At 8 years' follow-up, successful CTO PCI was associated with reduced mortality in women (14.8% vs 36.2%, p = 0.003) and men (18.5% vs 29.1%, p < 0.001). In successful CTO PCI cases, no sex-related differences were observed in terms of major adverse cardiac events. CONCLUSIONS: Our study suggests an equal benefit of CTO interventions with a marked reduction in mortality after successful CTO PCI in women and men alike.

19.
Sci Rep ; 9(1): 6664, 2019 Apr 30.
Artigo em Inglês | MEDLINE | ID: mdl-31040349

RESUMO

Within mosquito vector populations, infectious mosquitoes are the ones completing the transmission of pathogens to susceptible hosts and they are, consequently, of great epidemiological interest. Mosquito infection by malaria parasites has been shown to affect several traits of mosquito physiology and behavior, and could interplay with the efficacy of control tools. In this study, we evaluated, in pyrethroid resistant Anopheles gambiae, the effect of mosquito infection with the human malaria parasite Plasmodium falciparum on the efficacy of nets treated with either the insecticide deltamethrin or the repellent DEET, measuring (i) mosquito success to pass through the net, (ii) blood-feeding on a host and (iii) chemicals-induced mortality. Infection of mosquitoes at non-infectious stage did not affect their success to pass through the net, to blood-feed, nor chemicals-induced mortality. At infectious stage, depending on replicates, infected mosquitoes had higher mortality rates than uninfected mosquitoes, with stronger effect in presence of DEET. This data evidenced a cost of infection on mosquito survival at transmissible stages of infection, which could have significant consequences for both malaria epidemiology and vector control. This stresses the need for understanding the combined effects of insecticide resistance and infection on the efficacy on control tools.

20.
Am J Cardiol ; 124(1): 90-97, 2019 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-31076081

RESUMO

Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) emerged has a less invasive treatment than surgery for patients with degenerated bioprosthesis. However, few data are currently available regarding results of ViV versus TAVI in native aortic valve. We aimed to compare hemodynamic performances and 1-year outcomes between patients who underwent ViV procedure and patients who underwent non-ViV TAVI. This bicentric study included all patients who underwent aortic ViV procedure for surgical bioprosthetic aortic failure between 2013 and 2017. All patients who underwent TAVI were included in the analysis during the same period. ViV and non-ViV patients were matched with 1:2 ratio according to size, type of TAVI device, age (±5 years), sex, and STS score. Primary end point was hemodynamic performance including mean aortic gradient and aortic regurgitation at 1-year follow-up. A total of 132 patients were included, 49 in the ViV group and 83 in the non-ViV group. Mean age was 82.8 ± 5.9 years, 55.3% were female. Mean STS score was 5.2% ± 3.1%. Self-expandable valves were implanted in 78.8% of patients. At 1-year follow-up, aortic mean gradient was significantly higher in ViV group (18.1 ± 9.4 mm Hg vs 11.4 ± 5.4 mm Hg; p < 0.0001) and 17 (38.6%) patients had a mean aortic gradient ≥20 mm Hg vs 6 (7.8%) in the non-ViV group (p = 0.0001). Aortic regurgitation > grade 2 were similar in both groups (p = 0.71). In the ViV group, new pacemaker implantation was less frequent (p = 0.01) and coronary occlusions occurred only in ViV group (n = 2 [4.1%]). At 1-year follow-up, 3 patients (2.3%) died from cardiac cause, 1 (2.1%) in the ViV group vs 2 (2.4%) in the non-ViV group (p = 0.9). There was no stroke. In conclusion, compared with TAVI in native aortic stenosis, ViV appears as a safe and feasible strategy in patients with impaired bioprosthesis. As 1-year hemodynamic performances seem better in native TAVI procedure, long-term follow-up should be assessed to determinate the impact of residual stenosis on outcomes and durability.


Assuntos
Estenose da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/cirurgia , Bioprótese , Próteses Valvulares Cardíacas , Reoperação , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Pressão Sanguínea/fisiologia , Feminino , Humanos , Masculino , Desenho de Prótese , Estudos Retrospectivos , Volume Sistólico/fisiologia , Fatores de Tempo , Resultado do Tratamento
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