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1.
Can J Cardiol ; 36(2): 159-169, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32036861

RESUMO

In this update, we focus on selected topics of high clinical relevance for health care providers who treat patients with heart failure (HF), on the basis of clinical trials published after 2017. Our objective was to review the evidence, and provide recommendations and practical tips regarding the management of candidates for the following HF therapies: (1) transcatheter mitral valve repair in HF with reduced ejection fraction; (2) a novel treatment for transthyretin amyloidosis or transthyretin cardiac amyloidosis; (3) angiotensin receptor-neprilysin inhibition in patients with HF and preserved ejection fraction (HFpEF); and (4) sodium glucose cotransport inhibitors for the prevention and treatment of HF in patients with and without type 2 diabetes. We emphasize the roles of optimal guideline-directed medical therapy and of multidisciplinary teams when considering transcatheter mitral valve repair, to ensure excellent evaluation and care of those patients. In the presence of suggestive clinical indices, health care providers should consider the possibility of cardiac amyloidosis and proceed with proper investigation. Tafamidis is the first agent shown in a prospective study to alter outcomes in patients with transthyretin cardiac amyloidosis. Patient subgroups with HFpEF might benefit from use of sacubitril/valsartan, however, further data are needed to clarify the effect of this therapy in patients with HFpEF. Sodium glucose cotransport inhibitors reduce the risk of incident HF, HF-related hospitalizations, and cardiovascular death in patients with type 2 diabetes and cardiovascular disease. A large clinical trial recently showed that dapagliflozin provides significant outcome benefits in well treated patients with HF with reduced ejection fraction (left ventricular ejection fraction ≤ 40%), with or without type 2 diabetes.

2.
Can J Cardiol ; 35(11): 1437-1448, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31679616

RESUMO

Transcatheter aortic valve implantation (TAVI) or replacement has rapidly changed the treatment of patients with severe symptomatic aortic stenosis. It is now the standard of care for patients believed to be inoperable or at high surgical risk, and a reasonable alternative to surgical aortic valve replacement for those at intermediate surgical risk. Recent clinical trial data have shown the benefits of this technology in patients at low surgical risk as well. This update of the 2012 Canadian Cardiovascular Society TAVI position statement incorporates clinical evidence to provide a practical framework for patient selection that does not rely on surgical risk scores but rather on individual patient evaluation of risk and benefit from either TAVI or surgical aortic valve replacement. In addition, this statement features new wait time categories and treatment time goals for patients accepted for TAVI. Institutional requirements and recommendations for operator training and maintenance of competency have also been revised to reflect current standards. Procedural considerations such as decision-making for concomitant coronary intervention, antiplatelet therapy after intervention, and follow-up guidelines are also discussed. Finally, we suggest that all patients with aortic stenosis might benefit from evaluation by the heart team to determine the optimal individualized treatment decision.

3.
Circulation ; 140(23): 1881-1891, 2019 Dec 03.
Artigo em Inglês | MEDLINE | ID: mdl-31564137

RESUMO

BACKGROUND: The COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) demonstrated that edge-to-edge transcatheter mitral valve repair (TMVr) with the MitraClip resulted in reduced mortality and heart failure hospitalizations and improved quality of life compared with maximally tolerated guideline-directed medical therapy (GDMT) in patients with heart failure and 3 to 4+ secondary mitral regurgitation. Whether TMVr is cost-effective compared with GDMT in this population is unknown. METHODS: We used data from the COAPT trial to perform a formal patient-level economic analysis of TMVr+GDMT versus GDMT alone for patients with heart failure and 3 to 4+ secondary mitral regurgitation from the perspective of the US healthcare system. Costs for the index TMVr hospitalization were assessed using a combination of resource-based accounting and hospital billing data (when available). Follow-up medical care costs were estimated on the basis of medical resource use collected during the COAPT trial. Health utilities were estimated for all patients at baseline and 1, 6, 12, and 24 months with the Short Form Six-Dimension Health Survey. RESULTS: Initial costs for the TMVr procedure and index hospitalization were $35 755 and $48 198, respectively. Although follow-up costs were significantly lower with TMVr compared with GDMT ($26 654 versus $38 345; P=0.018), cumulative 2-year costs remained higher with TMVr because of the upfront cost of the index procedure ($73 416 versus $38 345; P<0.001). When in-trial survival, health utilities, and costs were modeled over a lifetime horizon, TMVr was projected to increase life expectancy by 1.13 years and quality-adjusted life-years by 0.82 years at a cost of $45 648, yielding a lifetime incremental cost-effectiveness ratio of $40 361 per life-year gained and $55 600 per quality-adjusted life-year gained. CONCLUSIONS: For symptomatic patients with heart failure and 3 to 4+ secondary mitral regurgitation, TMVr increases life expectancy and quality-adjusted life expectancy compared with GDMT at an incremental cost per quality-adjusted life-year gained that represents acceptable economic value according to current US thresholds. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01626079.

4.
JACC Clin Electrophysiol ; 5(6): 671-680, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31221353

RESUMO

OBJECTIVES: This study sought to assess the feasibility, safety, and outcomes of a stepwise combined percutaneous approach that includes transvenous lead extraction (TLE) followed by baffle stenting and device reimplantation in patients with D-transposition of the great arteries (D-TGA) and atrial baffle dysfunction. BACKGROUND: Management of baffle leak or stenosis in patients with D-TGA and atrial switch surgery is challenging in the presence of transvenous cardiac implantable electronic devices. Baffle complications hinder device-related interventions and addressing baffle dysfunction often requires TLE. METHODS: All consecutive patients with D-TGA and TLE followed by a percutaneous baffle intervention at the Montreal Heart Institute between 2009 and 2018 were enrolled. RESULTS: Ten patients, median 38.6 years of age (range 15.2 to 50.6 years), 5 males (50.0%) were included. Procedures were performed for a device-related indication in 5 patients (50.0%) and for baffle dysfunction in 5 patients (50.0%). A total of 19 leads (17 pacing, 2 defibrillation) were targeted, with a median time from implantation of 8.7 (range 4.3 to 22.1) years. A laser sheath was most frequently required for successful TLE, which was achieved in all patients. Immediate baffle stenting was performed in 9 patients (90.0%) and immediate device reimplantation in 6 (60.0%). During a median follow-up of 3.0 (range 0.1 to 8.2) years, the only complication was subpulmonary atrioventricular valve damage requiring surgery in 1 patient, 8 months after the procedure. CONCLUSIONS: A combined approach with TLE followed by baffle stenting and reimplantation appears to be safe and feasible in D-TGA patients with atrial switch, baffle dysfunction, and transvenous leads.

5.
Interv Cardiol Clin ; 8(3): 269-278, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31078182

RESUMO

Transcatheter mitral valve replacement is the focus of much enthusiasm as the future of therapy for mitral valve disease. Despite technological advances, left ventricular outflow tract (LVOT) obstruction from the valve prosthesis remains an important issue. In this review the authors discuss the pathophysiology of LVOT obstruction in both the surgical and transcatheter experience, imaging evaluation preprocedure, outcomes to date, and therapeutic options.

6.
Catheter Cardiovasc Interv ; 93(7): 1374-1381, 2019 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-31116908

RESUMO

BACKGROUND/OBJECTIVE: Prostar XL (PS) and ProGlide (PG) are common vascular closure devices (VCD) used in TAVR via transfemoral vascular approach. The impact of these VCD on vascular and bleeding complications remains unclear. METHODS: The BRAVO-3 trial randomized 802 patients undergoing transfemoral TAVR. We stratified patients according to type of VCD used and examined the 30-day incidence of major or minor vascular complications, major bleeding (BARC ≥3b), AKI and major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction or stroke). RESULTS: A total of 746 (93%) patients were treated with either PS (n = 352, 47%) or PG (n = 394, 53%) VCD, without significant differences in successful deployment rate (PS 322 [91.2%] vs. PG 373 [94.2%] respectively, p = .20). PG was associated with a significantly lower incidence of major or minor vascular complications, compared to PS (adjusted OR: 0.54; 95% CI: 0.37-0.80; p < .01). Rates of acute kidney injury were also lower with the PG device. There was no significant difference between bleeding, MACCE, and death. CONCLUSIONS: Compared to PS, the PG VCD was associated with a lower rate of major or minor vascular complications and lower rates of AKI after transfemoral TAVR.

7.
JACC Cardiovasc Interv ; 12(8): 781-789, 2019 Apr 22.
Artigo em Inglês | MEDLINE | ID: mdl-31000014

RESUMO

OBJECTIVES: The authors sought to assess the distribution and prognostic significance of habitual physical activity (HPA) in older adults undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Low HPA is associated with mortality and disability in community-dwelling older adults. In the setting of TAVR, it is unclear whether low HPA is a risk factor for downstream morbidity or a byproduct of severe aortic stenosis that improves following its correction. METHODS: Older adults undergoing TAVR in the prospective multicentre FRAILTY-AVR (Frailty in Aortic Valve Replacement) study were interviewed to quantify their HPA in kilocalories/week using a validated questionnaire at baseline and follow-up. The primary endpoint was all-cause mortality at 12 months. RESULTS: The cohort consisted of 755 patients with a median age of 84.0 years (interquartile range [IQR]: 80.0 to 87.0 years). At baseline, median HPA was 1,116 kcal/week (IQR: 227 to 2,715 kcal/week) with 73% of patients performing <150 min/week of moderate or vigorous HPA. Sedentary patients were more likely to be older, female, frail, cognitively impaired, depressed, and have multimorbidity, although they had similar left ventricular function and aortic stenosis severity. In the logistic regression model adjusting for these covariates, HPA was found to be associated with mortality at 12 months (odds ratio: 0.84/100 kcal; 95% confidence interval: 0.73 to 0.98). HPA was associated with longer length of stay, discharge to health care facilities, and disability. At 12 months, median HPA among survivors was 933 kcal/week (IQR: 0 to 2,334 kcal/week) with pre-existing frailty being independently predictive of worsening HPA following TAVR. CONCLUSIONS: Sedentary patients have a higher risk of mortality and functional decline following TAVR.

8.
Circ Cardiovasc Qual Outcomes ; 12(3): e005363, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30879326

RESUMO

Background Women account for a large proportion of patients treated with transcatheter aortic valve replacement, yet there remain conflicting reports about the effect of sex on outcomes. Moreover, the sex-specific prevalence and prognostic impact of frailty has not been systematically studied in the context of transcatheter aortic valve replacement. Methods and Results A preplanned analysis of the FRAILTY-AVR study (Frailty Aortic Valve Replacement) was performed to analyze the determinants of outcomes in older women and men undergoing transcatheter aortic valve replacement. FRAILTY-AVR was a multinational, prospective, observational cohort assembled at 14 institutions in North America and Europe from 2012 to 2017. Multivariable logistic regression models were stratified by sex and adjusted for covariates. Interaction between sex and each of these covariates was assessed. The primary outcome was 12-month mortality, and the secondary outcome was 1-month composite mortality or major morbidity. The cohort consisted of 340 women and 419 men. Women were older and had higher predicted risk of mortality. Women were more likely to have physical frailty traits, but not cognitive or psychosocial frailty traits, and global indices of frailty were similarly associated with adverse events regardless of sex. Women were more likely to require discharge to a rehabilitation facility, particularly those with physical frailty at baseline, although their functional status was similar to men at 12 months. The risk of 1-month mortality or major morbidity was greater in women, particularly those treated with larger prostheses. The risk of 12-month mortality was not greater in women, with the exception of those with pulmonary hypertension, in whom, there was a significant interaction for increased mortality. Conclusions The present study highlights sex-specific differences in older adults undergoing transcatheter aortic valve replacement and draws attention to the impact of physical frailty in women and their potential risk associated with oversized prostheses and pulmonary hypertension.

9.
JACC Cardiovasc Interv ; 12(5): 459-469, 2019 03 11.
Artigo em Inglês | MEDLINE | ID: mdl-30846085

RESUMO

OBJECTIVES: The authors sought to prospectively determine the safety and efficacy of next-day discharge using the Vancouver 3M (Multidisciplinary, Multimodality, but Minimalist) Clinical Pathway. BACKGROUND: Transfemoral transcatheter aortic valve replacement (TAVR) is an alternative to surgery in high- and intermediate-risk patients; however, hospital stays average at least 6 days in most trials. The Vancouver 3M Clinical Pathway is focused on next-day discharge, made possible by the use of objective screening criteria as well as streamlined peri- and post-procedural management guidelines. METHODS: Patients were enrolled from 6 low-volume (<100 TAVR/year), 4 medium-volume, and 3 high-volume (>200 TAVR/year) centers in Canada and the United States. The primary outcomes were a composite of all-cause death or stroke by 30 days and the proportion of patients successfully discharged home the day following TAVR. RESULTS: Of 1,400 screened patients, 411 were enrolled at 13 centers and received a SAPIEN XT (58.2%) or SAPIEN 3 (41.8%) valve (Edwards Lifesciences, Irvine, California). In centers enrolling exclusively in the study, 55% of screened patients were enrolled. The median age was 84 years (interquartile range: 78 to 87 years) with a median STS score of 4.9% (interquartile range: 3.3% to 6.8%). Next-day discharge home was achieved in 80.1% of patients, and within 48 h in 89.5%. The composite of all-cause mortality or stroke by 30 days occurred in 2.9% (95% confidence interval: 1.7% to 5.1%), with neither component of the primary outcome affected by hospital TAVR volume (p = 0.51). Secondary outcomes at 30 days included major vascular complication 2.4% (n = 10), readmission 9.2% (n = 36), cardiac readmission 5.7% (n = 22), new permanent pacemaker 5.7% (n = 23), and >mild paravalvular regurgitation 3.8% (n = 15). CONCLUSIONS: Adherence to the Vancouver 3M Clinical Pathway at low-, medium-, and high-volume TAVR centers allows next-day discharge home with excellent safety and efficacy outcomes.

10.
Can J Cardiol ; 35(2): 178-184, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30760424

RESUMO

BACKGROUND: Echocardiographic evaluation of the systemic right ventricle (sRV) remains challenging in patients with transposition of the great arteries (TGA) corrected by an atrial switch (AS) and with congenitally corrected TGA (ccTGA). The aim of this study was to determine the interobserver and intraobserver variability of echocardiographic parameters for sRV size and systolic function. METHODS: Six independent observers retrospectively interpreted 44 previously acquired echocardiograms (25 patients with TGA/AS and 19 patients with ccTGA). Quantitative parameters included inlet and longitudinal diameters, systolic and diastolic areas, fractional area change (FAC), and wall thickness. sRV dilatation and systolic function were qualitatively graded as normal, mild, moderate, or severe. sRV hypertrophy was graded as present or absent. Intraclass correlation coefficients (ICCs) and Kappa statistics were computed to assess interobserver variability. Images from 10 patients (5 TGA/AS and 5 ccTGA) were reinterpreted at a 1-month interval, and ICC and Kendall tau b statistics were computed to assess intraobserver variability. RESULTS: Interobserver and intraobserver agreement were good to excellent for sRV diameters, areas and FAC (ICC, 0.49-0.97), except for the sRV wall thickness (ICC < 0) and the FAC for 1 observer. Interobserver agreement was poor for the qualitative assessment of sRV size and systolic function (Kappa < 0.25), but with a good to excellent intraobserver agreement. CONCLUSIONS: These findings suggest that overall appreciation of sRV size and systolic function relies on variable interpretation of measurements by observers. Readers experienced in CHD and with clear thresholds for quantitative parameters, along with a validated algorithm, are required to guide the evaluation of sRV.


Assuntos
Ecocardiografia/métodos , Ventrículos do Coração/diagnóstico por imagem , Transposição dos Grandes Vasos/diagnóstico , Função Ventricular Direita/fisiologia , Adulto , Feminino , Ventrículos do Coração/fisiopatologia , Humanos , Masculino , Curva ROC , Estudos Retrospectivos , Sístole , Transposição dos Grandes Vasos/fisiopatologia
11.
JACC Cardiovasc Interv ; 12(1): 65-75, 2019 01 14.
Artigo em Inglês | MEDLINE | ID: mdl-30621980

RESUMO

OBJECTIVES: The authors assessed the effect of valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) followed by bioprosthetic valve fracture (BVF), testing different transcatheter heart valve (THV) designs in an ex vivo bench study. BACKGROUND: Bioprosthetic valve fracture can be performed to improve residual transvalvular gradients following VIV TAVR. METHODS: The authors evaluated VIV TAVR and BVF with the SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, California) and ACURATE neo (Boston Scientific Corporation, Natick, Massachusetts) THVs. A 20-mm and 23-mm S3 were deployed in a 19-mm and 21-mm Mitroflow (Sorin Group USA, Arvada, Colorado), respectively. A small ACURATE neo was deployed in both sizes of Mitroflow tested. VIV TAVR samples underwent multimodality imaging, and hydrodynamic evaluation before and after BVF. RESULTS: A high implantation was required to enable full expansion of the upper crown of the ACURATE neo and allow optimal leaflet function. Marked underexpansion of the lower crown of the THV within the surgical valve was also observed. Before BVF, VIV TAVR in the 19-mm Mitroflow had high transvalvular gradients using either THV design (22.0 mm Hg S3, and 19.1 mm Hg ACURATE neo). After BVF, gradients improved and were similar for both THVs (14.2 mm Hg S3, and 13.8 mm Hg ACURATE neo). The effective orifice area increased with BVF from 1.2 to 1.6 cm2 with the S3 and from 1.4 to 1.6 cm2 with the ACURATE neo. Before BVF, VIV TAVR with the ACURATE neo in the 21-mm Mitroflow had lower gradients compared with S3 (11.3 mm Hg vs. 16 mm Hg). However, after BVF valve gradients were similar for both THVs (8.4 mm Hg ACURATE neo vs. 7.8 mm Hg S3). The effective orifice area increased from 1.5 to 2.1 cm2 with the S3 and from 1.8 to 2.2 cm2 with the ACURATE neo. CONCLUSIONS: BVF performed after VIV TAVR results in improved residual gradients. Following BVF, residual gradients were similar irrespective of THV design. Use of a small ACURATE neo for VIV TAVR in small (≤21 mm) surgical valves may be associated with challenges in achieving optimum THV position and expansion. BVF could be considered in selected clinical cases.


Assuntos
Bioprótese , Próteses Valvulares Cardíacas , Desenho de Prótese , Substituição da Valva Aórtica Transcateter/instrumentação , Valvuloplastia com Balão , Teste de Materiais , Falha de Prótese
12.
Cardiovasc Revasc Med ; 20(3): 228-234, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30075958

RESUMO

BACKGROUND: Scaffold thromboses (ST) and adverse events and have been associated with bioresorbable vascular scaffolds (BVS) at long-term, but their mechanism remains unclear. We sought to evaluate patient and lesion characteristics associated with mid- to long-term outcomes in patients treated with BVS. METHODS: This is an observational single-center, single-arm, retrospective study evaluating the performance of BVS in an all-comer population, including complex lesions (chronic total occlusions, long lesions), small vessels, and acute coronary syndromes (ACS). RESULTS: From May 2013 to June 2015, we included 482 patients (580 lesions) that were treated with BVS implantation including 71.2% treated for ACS in the present analysis. Mean follow-up period was 816.2 ±â€¯242.6 days. The primary endpoint was device oriented cardiac events (DOCE), defined as a composite of target-lesion revascularization (TLR), ST, target vessel myocardial infarction (TVMI) and cardiac death. Using Kaplan-Meier methods, the DOCE and ST rates at 36 months were 9.4% and 2.3%, respectively. No ST occurred between 2 and 3 years and ST occurred after 3 years, in one patient. Using multivariate analysis, ACS was the only significant predictor of lower rates of DOCE (p = 0.04, HR: 0.47, 95% CI: 0.23-0.96). CONCLUSIONS: In this large all-comers real-world cohort, lesions treated with BVS had non-negligible rates of DOCE and ST, in line with previous published randomized trials. The occurrence of very late event was very low after 24 months. ACS patients had lower rates of DOCE.

13.
Circ Cardiovasc Qual Outcomes ; 11(12): e004947, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30562064

RESUMO

BACKGROUND: Public reporting of hospital-level outcomes is increasingly common as a means to target quality improvement strategies to ensure the delivery of optimal care. Despite the rapid dissemination of transcatheter aortic valve replacement (TAVR), there is a paucity of reliable case-mix adjustment models for hospital profiling in TAVR. Our objective was to develop and evaluate different models for calculating risk-standardized all-cause mortality rates (RSMRs) post-TAVR. METHODS AND RESULTS: In this population-based study in Ontario, Canada, we identified all patients who underwent a TAVR procedure between April 1, 2012, and March 31, 2016. For each hospital, we calculated 30-day and 1-year RSMR, using 2-level hierarchical logistic regression models that accounted for patient-specific demographic and clinical characteristics, as well as the clustering of patients within the same hospital using a hospital-specific random effects. We classified each hospital into one of 3 groups: performing worse than expected, better than expected, or performing as expected, based on whether the 95% CI of the RSMR was above, below, or included the provincial average mortality rate, respectively. Our cohort consisted of 2129 TAVR procedures performed at 10 hospitals. The observed mortality was 7.0% at 30 days and 16.4% at 1 year, with a range of 4% to 10% and 8% to 22%, respectively, across hospitals. We developed case-mix adjustment models using 28 clinically relevant variables. Using 30-day and 1-year RSMR to profile each hospital, we found that all hospitals performed as expected, with 95% CI that included the provincial average. CONCLUSIONS: We found no significant interhospital variation in RSMR among hospitals, suggesting that quality improvement efforts should be directed at aspects other than the variation in observed mortality.


Assuntos
Valva Aórtica/cirurgia , Hospitais/tendências , Indicadores de Qualidade em Assistência à Saúde/tendências , Substituição da Valva Aórtica Transcateter/mortalidade , Idoso , Idoso de 80 Anos ou mais , Feminino , Disparidades em Assistência à Saúde/tendências , Mortalidade Hospitalar/tendências , Humanos , Masculino , Ontário , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/tendências , Resultado do Tratamento
16.
JACC Cardiovasc Interv ; 11(21): 2185-2192, 2018 11 12.
Artigo em Inglês | MEDLINE | ID: mdl-30343019

RESUMO

OBJECTIVES: The authors sought to determine whether frail older adults undergoing nonfemoral transcatheter aortic valve replacement (TAVR) procedures had a higher risk of 30-day and 12-month mortality. BACKGROUND: Frailty can help predict outcomes and guide therapy in older adults being considered for TAVR. Nonfemoral TAVR procedures are more invasive and impart a greater risk of adverse events, which may be less well tolerated in frail patients, compared with transfemoral TAVR procedures. METHODS: This study was a post hoc analysis of the FRAILTY-AVR (Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions) prospective multicenter cohort that consisted of older adults undergoing TAVR from 2012 to 2017. Frailty was assessed using the Essential Frailty Toolset (EFT). Endpoints of interest were 30-day and 12-month all-cause mortality. Interaction tables and multivariable logistic regression models were used to investigate statistical interaction on the additive and multiplicative scales. RESULTS: The cohort consisted of 723 patients with a mean age of 84 ± 6 years, of which 556 (77%) had femoral access and 167 (23%) had nonfemoral access. In frail patients with EFT scores ≥3 (35%), nonfemoral access was associated with increased 30-day mortality (odds ratio [OR]: 3.91; 95% confidence interval [CI]: 1.48 to 10.31); whereas in nonfrail patients with EFT scores <3 (65%), nonfemoral access had no effect (OR: 1.29; 95% CI: 0.34 to 4.94). There was statistical evidence of interaction between frailty and access site on 30-day mortality on the additive scale (relative excess risk due to interaction = 5.95). Nonfemoral access was associated with increased 1-year mortality in frail patients (OR: 1.98; 95% CI: 1.00 to 3.93) but not in nonfrail patients (OR: 1.83; 95% CI: 0.90 to 3.74), although there was no statistical evidence of interaction. CONCLUSIONS: Frail patients undergoing TAVR via a more invasive nonfemoral access face a substantially higher risk of 30-day mortality, whereas nonfrail older adults tolerate the procedure with a low short-term risk irrespective of access route.


Assuntos
Estenose da Valva Aórtica/cirurgia , Cateterismo Periférico/efeitos adversos , Artéria Femoral , Idoso Fragilizado , Fragilidade/complicações , Substituição da Valva Aórtica Transcateter/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Canadá , Cateterismo Periférico/mortalidade , Feminino , Fragilidade/diagnóstico , Fragilidade/mortalidade , França , Avaliação Geriátrica , Humanos , Masculino , Estudos Prospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento , Estados Unidos
17.
J Med Econ ; 21(11): 1091-1095, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30099924

RESUMO

BACKGROUND: Vascular complications are an important complication of transcatheter aortic valve implantation and are associated with increased morbidity and mortality as well as cost. The Solopath device is an expandable vascular access system that has previously been shown to be associated with lower rates of vascular complications. This study sought to evaluate the impact of the use of this system on vascular complications and costs in a decision model analysis. METHODS: A cost-consequence analysis was undertaken utilizing event rate data from the PARTNER trials and a published retrospective analysis of the Solopath device. The decision model estimated costs and benefits in a hypothetical cohort of patients with aortic stenosis undergoing TAVI using either a standard sheath or Solopath. The modeled analysis compared the occurrence of vascular complications and mortality at 30 days and 1 year using TreeAge Pro. RESULTS: The decision model demonstrated that use of the Solopath sheath resulted in 36 fewer major vascular complications, three fewer deaths at 30 days, and five fewer deaths at 1 year, resulting in a discounted cost savings of $846 CDN. Results were sensitive to decreasing rates of vascular complications with newer generation devices, however maintained modest cost-savings. CONCLUSIONS: Reduction in vascular complications is an important part of improving care for TAVI patients. The Solopath vascular access device offers an alternative to standard sheaths with a potential reduction in complications and cost-savings.


Assuntos
Estenose da Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter/economia , Substituição da Valva Aórtica Transcateter/instrumentação , Técnicas de Apoio para a Decisão , Gastos em Saúde , Recursos em Saúde/estatística & dados numéricos , Humanos , Modelos Econométricos , Estudos Retrospectivos
18.
Circulation ; 138(20): 2202-2211, 2018 11 13.
Artigo em Inglês | MEDLINE | ID: mdl-29976568

RESUMO

BACKGROUND: Older adults undergoing aortic valve replacement (AVR) are at risk for malnutrition. The association between preprocedural nutritional status and midterm mortality has yet to be determined. METHODS: The FRAILTY-AVR (Frailty in Aortic Valve Replacement) prospective multicenter cohort study was conducted between 2012 and 2017 in 14 centers in 3 countries. Patients ≥70 years of age who underwent transcatheter or surgical AVR were eligible. The Mini Nutritional Assessment-Short Form was assessed by trained observers preprocedure, with scores ≤7 of 14 considered malnourished and 8 to 11 of 14 considered at risk for malnutrition. The Short Performance Physical Battery was simultaneously assessed to measure physical frailty, with scores ≤5 of 12 considered severely frail and 6 to 8 of 12 considered mildly frail. The primary outcome was 1-year all-cause mortality, and the secondary outcome was 30-day composite mortality or major morbidity. Multivariable regression models were used to adjust for potential confounders. RESULTS: There were 1158 patients (727 transcatheter AVR and 431 surgical AVR), with 41.5% females, a mean age of 81.3 years, a mean body mass index of 27.5 kg/m2, and a mean Society of Thoracic Surgeons-Predicted Risk of Mortality of 5.1%. Overall, 8.7% of patients were classified as malnourished and 32.8% were at risk for malnutrition. Mini Nutritional Assessment-Short Form scores were modestly correlated with Short Performance Physical Battery scores (Spearman R=0.31, P<0.001). There were 126 deaths in the transcatheter AVR group (19.1 per 100 patient-years) and 30 deaths in the surgical AVR group (7.5 per 100 patient-years). Malnourished patients had a nearly 3-fold higher crude risk of 1-year mortality compared with those with normal nutritional status (28% versus 10%, P<0.001). After adjustment for frailty, Society of Thoracic Surgeons-Predicted Risk of Mortality, and procedure type, preprocedural nutritional status was a significant predictor of 1-year mortality (odds ratio, 1.08 per Mini Nutritional Assessment-Short Form point; 95% CI, 1.01-1.16) and of the 30-day composite safety end point (odds ratio, 1.06 per Mini Nutritional Assessment-Short Form point; 95% CI, 1.001-1.12). CONCLUSIONS: Preprocedural nutritional status is associated with mortality in older adults undergoing AVR. Clinical trials are needed to determine whether pre- and postprocedural nutritional interventions can improve clinical outcomes in these vulnerable patients.


Assuntos
Estenose da Valva Aórtica/patologia , Desnutrição/patologia , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/cirurgia , Índice de Massa Corporal , Estudos de Coortes , Feminino , Idoso Fragilizado , Humanos , Estimativa de Kaplan-Meier , Modelos Logísticos , Masculino , Desnutrição/complicações , Estado Nutricional , Razão de Chances , Estudos Prospectivos , Fatores de Risco , Índice de Gravidade de Doença
19.
Can J Cardiol ; 34(4): 422-428, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29395700

RESUMO

Aortic stenosis (AS), 1 of the most common valve diseases in developed countries, carries a poor prognosis if left untreated. Transcatheter aortic valve replacement (TAVR) has become the standard of care for high-risk and inoperable patients with severe aortic stenosis (AS). Women represent a significant proportion of patients with severe AS and demonstrate specific clinical, anatomic, and pathophysiological features that are evident both before and after valve replacement. In this review, we discuss these features as well as the outcomes of women undergoing TAVR for AS.


Assuntos
Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/cirurgia , Feminino , Humanos , Risco Ajustado/métodos , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Substituição da Valva Aórtica Transcateter/normas
20.
Can J Cardiol ; 34(3): 330-332, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-29475532

RESUMO

Transcatheter aortic valve implantation (TAVI) is a disruptive technology that has dramatically changed the way clinicians care for patients with aortic stenosis. In 15 short years, this technology has progressed from first-in-human to the standard of care for high-risk and inoperable patients with aortic stenosis. In 2016 the Canadian Cardiovascular Society published the first ever report of quality of care for TAVI in Canada. This report provided multiple insights into evaluating such care delivered to Canadians and the challenges that lie ahead. In this article, we summarize these challenges and encourage cardiologists to join the call to arms for improving quality of TAVI care in Canada.


Assuntos
Estenose da Valva Aórtica/cirurgia , Melhoria de Qualidade , Sistema de Registros , Substituição da Valva Aórtica Transcateter/mortalidade , Substituição da Valva Aórtica Transcateter/métodos , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Canadá , Bases de Dados Factuais , Feminino , Humanos , Masculino , Procedimentos Cirúrgicos Minimamente Invasivos/efeitos adversos , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Procedimentos Cirúrgicos Minimamente Invasivos/mortalidade , Indicadores de Qualidade em Assistência à Saúde , Estudos Retrospectivos , Medição de Risco , Taxa de Sobrevida , Substituição da Valva Aórtica Transcateter/efeitos adversos
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