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1.
Circ Cardiovasc Interv ; 13(3): e008425, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32138529

RESUMO

BACKGROUND: Transcatheter mitral valve replacement using aortic transcatheter heart valves has recently become an alternative for patients with degenerated mitral bioprostheses, failed surgical repairs with annuloplasty rings or severe mitral annular calcification who are poor surgical candidates. Outcomes of these procedures are collected in the Society of Thoracic Surgeons/American College of Cardiology/Transcatheter Valve Therapy Registry. A comprehensive analysis of mitral valve-in-valve (MViV), mitral valve-in-ring (MViR), and valve-in-mitral annular calcification (ViMAC) outcomes has not been performed. We sought to evaluate short-term outcomes of early experience with MViV, MViR, and ViMAC in the United States. METHODS: Retrospective analysis of data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. RESULTS: Nine hundred three high-risk patients (median Society of Thoracic Surgeons score 10%) underwent MViV (n=680), MViR (n=123), or ViMAC (n=100) between March 2013 and June 2017 at 172 hospitals. Median age was 75 years, 59.2% female. Technical and procedural success were higher in MViV. Left ventricular outflow tract obstruction occurred more frequently with ViMAC (ViMAC=10%, MViR=4.9%, MViV=0.7%; P<0.001). In-hospital mortality (MViV=6.3%, MViR=9%, ViMAC=18%; P=0.004) and 30-day mortality (MViV=8.1%, MViR=11.5%, ViMAC=21.8%; P=0.003) were higher in ViMAC. At 30-day follow-up, median mean mitral valve gradient was 7 mm Hg, most patients (96.7%) had mitral regurgitation grade ≤1 (+) and were in New York Heart Association class I to II (81.7%). CONCLUSIONS: MViV using aortic balloon-expandable transcatheter heart valves is associated with a low complication rate, a 30-day mortality lower than predicted by the Society of Thoracic Surgeons score, and superior short-term outcomes than MViR and ViMAC. At 30 days, patients in all groups experienced improvement of symptoms, and valve performance remained stable. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02245763.

3.
J Vasc Surg ; 2020 Feb 14.
Artigo em Inglês | MEDLINE | ID: mdl-32067876

RESUMO

OBJECTIVE: The timing of operative revascularization for patients with concomitant carotid artery stenosis and coronary artery disease remains controversial. We examined the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database to evaluate the association of combined carotid endarterectomy (CEA) and coronary artery bypass grafting (CABG) with postoperative outcomes. METHODS: All patients undergoing CABG with known carotid stenosis of >80% were identified from 2011 to 2016. Individuals were stratified by use of cardiopulmonary bypass and whether a concomitant CEA was performed at the time of CABG. Multivariate logistic regression was used to model the probability of combined CABG and CEA. The resulting propensity scores were used to match individuals on the basis of clinical and operative characteristics to evaluate primary (30-day mortality and in-hospital transient ischemic attack and stroke) and secondary (STS morbidity composite events and length of stay) end points, with P < .05 required to declare statistical significance. RESULTS: After propensity score matching, 994 off-pump CABG patients (497 CABG only and 497 CABG-CEA) and 5952 on-pump CABG patients (2976 CABG only and 2976 CABG-CEA) were identified. For patients who received on-pump operations, those undergoing CABG-CEA had no observed difference in rate of in-hospital stroke (odds ratio [OR], 0.93; 95% confidence interval [CI], 0.72-1.21; P = .6), higher incidence of STS morbidity composite events (OR, 1.15, 95% CI, 1.01-1.31; P = .03), longer length of stay (7.0 [interquartile range, 5.0-9.0] days vs 6.0 [interquartile range, 5.0-9.0] days; P < .005), and no observed difference in 30-day mortality (OR, 1.28; 95% CI, 0.97-1.69; P = .08) compared with those undergoing CABG only. For off-pump procedures, CABG-CEA patients had no observed difference in rate of in-hospital stroke (OR, 0.80; 95% CI, 0.37-1.69; P = .56) compared with those undergoing CABG only. CONCLUSIONS: Whereas the differences are relatively small, these data suggest that a combined CABG-CEA approach is unlikely to provide significant stroke reduction benefit compared with CABG only. However, comparison with staged approaches merits further investigation.

4.
Circulation ; 2020 Feb 26.
Artigo em Inglês | MEDLINE | ID: mdl-32098500

RESUMO

Background: Patients with bicuspid aortic valve (AV) stenosis were excluded from the pivotal evaluations of transcatheter AV replacement (TAVR) devices. We sought to evaluate the outcomes of TAVR in patients with bicuspid AV stenosis compared with those with tricuspid AV. Methods: We used data from the Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy Registry (November 2011-November 2018) to determine device success, procedural outcomes, post-TAVR valve performance, and in-hospital clinical outcomes (mortality, stroke, and major bleeding) according to valve morphology (bicuspid vs. tricuspid). Results were stratified by older and current (Sapien 3 and Evolut R) generation valve prostheses. Medicare administrative claims were used to evaluate mortality and stroke to 1 year among eligible individuals (≥65 years). Results: After exclusions, there were 170,959 eligible procedures at 593 sites during the specified interval. Of these, 5,412 TAVR procedures (3.2%) were performed in bicuspid AV patients, including 3,705 with current generation devices. Compared to patients with tricuspid valves, bicuspid AV patients were younger and had a lower STS Predicted Risk of Operative Mortality (PROM) score. When current generation devices were used to treat bicuspid AV patients, device success increased (93.5 vs. 96.3, p=0.001) and the incidence of 2+ aortic insufficiency declined (14.0 vs. 2.7%, p<0.001) compared with older generation devices. With current generation devices, device success was slightly lower in the bicuspid (vs. tricuspid) AV group (96.3% in bicuspid vs. 97.4% in tricuspid, p=0.07), with a slightly higher incidence of residual moderate or severe aortic insufficiency among bicuspid AV patients (2.7% vs. 2.1%, p<0.001). A lower 1-year adjusted risk of mortality (hazard ratio 0.88, 95% confidence interval 0.78-0.99) was observed for bicuspid vs. tricuspid AV patients in the Medicare-linked cohort, while no difference was observed in the 1-year adjusted risk of stroke (hazard ratio 1.14, confidence interval 0.94-1.39). Conclusions: Using current generation devices, procedural, post-procedural, and 1-year outcomes were comparable following TAVR for bicuspid AV vs. tricuspid AV disease. With newer generation devices, TAVR is a viable treatment option for bicuspid AV patients.

5.
Circ Cardiovasc Interv ; 13(1): e008227, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31937138

RESUMO

BACKGROUND: Vascular and bleeding complications were commonly reported in transcatheter aortic valve replacement clinical trials. Little is known about complication rates in contemporary US clinical practice or clinical outcomes associated with these complications. METHODS: In the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, we evaluated patients undergoing transcatheter aortic valve replacement from November 1, 2011 to June 30, 2016. The primary outcomes were in-hospital vascular complications and bleeding events. Secondary outcomes included all-cause mortality, stroke, and rehospitalization at 1 year. P values for trends were calculated for rates over time, and multivariable logistic regression was used to determine the association between vascular/bleeding complications and in-hospital clinical outcomes. RESULTS: Overall, 34 893 patients undergoing transcatheter aortic valve replacement at 445 hospitals were analyzed. Of these, 9.3% (n=3257) experienced a vascular complication while 7.6% (n=2651) had an in-hospital bleeding event. Rates of both vascular complications and bleeding events decreased over time (P value for trend test <0.0001); however, there was significant variation in rates across hospital sites (adjusted median rate, 11.4%; IQR, 8.9-14.5). Vascular complications were independently associated with 30-day death (adjusted HR, 2.23 [95% CI, 1.80-2.77]) and death (adjusted HR, 1.17 [95% CI, 1.05-1.30]) and rehospitalization (adjusted HR, 1.14 [95% CI, 1.07-1.22]) at 1 year. Bleeding events were also associated with 30-day death (adjusted HR, 3.71 [95% CI, 2.94-4.69]), and with death (adjusted HR, 1.39 [95% CI, 1.23-1.56]) and hospital readmission (adjusted HR, 1.19 [95% CI, 1.11-1.27]) at 1 year. CONCLUSIONS: In patients undergoing transcatheter aortic valve replacement in the US, vascular complications and in-hospital bleeding events were common, but rates have declined over time with significant variation in complication rates across hospital sites. Vascular and bleeding complications are both associated with worse short- and long-term clinical outcomes including all-cause mortality. Further innovation to reduce sheath sizes and optimize antithrombotic therapy is necessary to reduce the incidence of these detrimental complications.

6.
Artigo em Inglês | MEDLINE | ID: mdl-31926005

RESUMO

BACKGROUND: While complications of TAVR have decreased, they still occur commonly and may negatively impact both short- and long-term outcomes. We sought to examine the association of complications after TAVR with survival and health status in a real world cohort. METHODS AND RESULTS: Among 45,884 TAVR patients from 513 US sites who survived 30 days, 21.4% had at least one major complication (stroke, bleed, vascular complication, new pacemaker, acute kidney injury [AKI], moderate/severe paravalvular leak [PVL]). In multivariable models, stage 3 AKI (HR 3.43, 95% CI 2.64-4.45), stroke (HR 2.62, 95% CI 2.06-3.32), and bleeding (HR 1.83, 95% CI 1.55-2.16) were independently associated with significantly increased risk of early death (<3 months) with slight attenuation in these hazards between 3 and 12 months. Moderate/severe PVL (HR 1.37, 95% CI 1.21-1.55) and new pacemaker (HR 1.15, 95% CI 1.05-1.25) were associated with more modest risk of excess mortality that was consistent through 12 months. Among surviving patients, stroke (-6.1 points, 95% CI -8.4 to -3.7), moderate/severe PVL (-3.2 points, 95% CI -4.9 to -1.6), and new pacemaker (-2.3, 95% CI -3.2 to -1.5) were associated with less improvement in 1-year health status, as assessed by the Kansas City Cardiomyopathy Questionnaire. CONCLUSIONS: In this study of contemporary TAVR, we found that complications remain common within the first 30 days after TAVR and are associated with worse one-year survival and health status among survivors. These findings support continued efforts to reduce major complications of TAVR and may also help define quality of care.

7.
N Engl J Med ; 382(9): 799-809, 2020 02 27.
Artigo em Inglês | MEDLINE | ID: mdl-31995682

RESUMO

BACKGROUND: There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk. METHODS: We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke. RESULTS: At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery. CONCLUSIONS: Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).


Assuntos
Estenose da Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Insuficiência da Valva Aórtica/etiologia , Insuficiência da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Estudos de Coortes , Ecocardiografia , Feminino , Nível de Saúde , Humanos , Incidência , Análise de Intenção de Tratamento , Estimativa de Kaplan-Meier , Masculino , Análise Multivariada , Complicações Pós-Operatórias/mortalidade , Fatores de Risco , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Resultado do Tratamento
8.
JACC Cardiovasc Interv ; 13(2): 219-231, 2020 Jan 27.
Artigo em Inglês | MEDLINE | ID: mdl-31973795

RESUMO

OBJECTIVES: This study sought to evaluate the ability of individual markers of frailty to predict outcomes after transcatheter aortic valve replacement (TAVR) and of their discriminatory value in different age groups. BACKGROUND: Appropriate patient selection for TAVR remains a dilemma, especially among the most elderly and potentially frail. METHODS: The study evaluated patients ≥65 years of age in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry, linked to Centers for Medicare and Medicaid administrative claims data, receiving elective TAVR from November 2011 to June 2016 (n = 36,242). Indices of frailty included anemia, albumin level, and 5-m walk speed. We performed Cox proportional hazards regression for 30-day and 1-year mortality, adjusting for risk factors known to be predictive of 30-day mortality in the Transcatheter Valve Therapy registry, as well as survival analysis. RESULTS: These indices are independently associated with mortality at 30 days and 1 year and provide incremental value in risk stratification for mortality, with low albumin providing the largest value (hazard ratio: 1.52). Those with low albumin and slower walking speed had longer lengths of stay and higher rates of bleeding and readmission (p < 0.001). Those with anemia also had higher rates of bleeding, readmission, and subsequent myocardial infarction (p < 0.001). CONCLUSIONS: This represents the largest study to date of the role of frailty indices after TAVR, further facilitating robust modeling and adjusting for a large number of confounders. These simple indices are easily attainable, and clinically relevant markers of frailty that may meaningfully stratify patients at risk for mortality after TAVR.

9.
Eur Heart J ; 41(8): 943-954, 2020 Feb 21.
Artigo em Inglês | MEDLINE | ID: mdl-31711153

RESUMO

AIMS: Left ventricular pressure overload is associated with activation of the cardiac renin-angiotensin system, which may contribute to myocardial fibrosis and worse clinical outcomes. We sought to assess the association between treatment with angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs) at baseline and clinical outcomes in patients with symptomatic, severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) in the PARTNER 2 trial and registries. METHODS AND RESULTS: A total of 3979 intermediate, high, or prohibitive risk patients who underwent TAVR in the PARTNER 2 trial and registries (excluding the valve in valve registry) were included in the study. Clinical outcomes at 2 years were compared according to baseline ACEI/ARB treatment status using Kaplan-Meier event rates and study-stratified multivariable Cox proportional hazards regression models. Sensitivity analysis was conducted using propensity score matching. Of 3979 patients who were included in the current analysis, 1736 (43.6%) were treated and 2243 (56.4%) were not treated with ACEI/ARB at baseline. Treatment with ACEI/ARB was associated with lower 2-year all-cause mortality (18.6% vs. 27.5%, P < 0.0001), cardiovascular mortality (12.3% vs. 17.9%, P < 0.0001), and non-cardiovascular mortality (7.2% vs. 11.7%, P < 0.0001). Angiotensin-converting enzyme inhibitor/ARB treatment at baseline remained independently associated with a lower hazard of 2-year all-cause and cardiovascular mortality after multivariable adjustment, and propensity score matching. CONCLUSION: In a large cohort of patients with severe symptomatic AS from the PARTNER 2 trial and registries, ACEI/ARB treatment at baseline was independently associated with a lower risk of 2-year all-cause and cardiovascular mortality.

10.
Ann Thorac Surg ; 109(3): 667-668, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31770503
12.
Ann Thorac Surg ; 109(2): 465-471, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31400333

RESUMO

BACKGROUND: Epiaortic ultrasound detects and localizes ascending aortic atherosclerosis. In this analysis we investigated the association between epiaortic ultrasound-based atheroma grade during surgical aortic valve replacement (SAVR) and perioperative adverse outcomes. METHODS: SAVR patients in a randomized trial of 2 embolic protection devices underwent a protocol-defined 5-view epiaortic ultrasound read at a core laboratory. Aortic atherosclerosis was quantified with the Katz atheroma grade, and patients were categorized as mild (grade I-II) or moderate/severe (grade III-V). Multivariable logistic regression was used to estimate associations between atheroma grade and adverse outcomes, including death, clinically apparent stroke, cerebral infarction on diffusion-weighted magnetic resonance imaging, delirium, and acute kidney injury (AKI) by 7 and 30 days. RESULTS: Precannulation epiaortic ultrasound data were available for 326 of 383 randomized patients (85.1%). Of these, 106 (32.5%) had moderate/severe Katz atheroma grade at any segment of the ascending aorta. Although differences in the composite of death, stroke, or cerebral infarction on diffusion-weighted magnetic resonance imaging by 7 days were not statistically significant, moderate/severe atheroma grade was associated with a greater risk of AKI by 7 days (adjusted odds ratio, 2.63; 95% confidence interval, 1.24-5.58; P = .01). At 30 days, patients with moderate/severe atheroma grade had a greater risk of death, stroke, or AKI (adjusted odds ratio, 1.97; 95% confidence interval, 1.04-3.71; P = .04). CONCLUSIONS: Moderate/severe aortic atherosclerosis was associated with an increased risk of adverse events after SAVR. Epiaortic ultrasound may serve as a useful adjunct for identifying patients who may benefit from strategies to reduce atheroembolic complications during SAVR.

13.
Ann Thorac Surg ; 109(1): 93, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31344345
14.
JACC Cardiovasc Interv ; 13(2): 210-216, 2020 Jan 27.
Artigo em Inglês | MEDLINE | ID: mdl-31883715

RESUMO

OBJECTIVES: The aim of this study was to report the 1-year results of transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli. BACKGROUND: Favorable 30-day outcomes of S3 TAVR in annuli >683 mm2 have previously been reported. Pacemaker implantation rates were acceptable, and a larger left ventricular outflow tract and more eccentric annular anatomy were associated with increasing paravalvular leak. METHODS: From December 2013 to December 2018, 105 patients across 15 centers with mean area 721.3 ± 36.1 mm2 (range 683.5 to 852.0 mm2) underwent TAVR using an S3 device. Clinical, anatomic, and procedural characteristics were analyzed. One-year survival and echocardiographic follow-up were reached in 94.3% and 82.1% of patients, respectively. Valve Academic Research Consortium-2 30-day and 1-year outcomes were reported. RESULTS: The mean age was 76.9 ± 10.4 years, and Society of Thoracic Surgeons predicted risk score averaged 5.2 ± 3.4%. One-year overall mortality and stroke rates were 18.2% and 2.4%, respectively. Quality-of-life index improved from baseline to 30 days and at 1 year (p < 0.001 for both). Mild paravalvular aortic regurgitation occurred in 21.7% of patients, while moderate or greater paravalvular aortic regurgitation occurred in 4.3%. Mild and moderate or severe transvalvular aortic regurgitation occurred in 11.6% and 0%, respectively. Valve gradients remained stable at 1 year. CONCLUSIONS: S3 TAVR in annular areas >683 mm2 is feasible, with favorable mid-term outcomes.

15.
Circulation ; 140(24): 1984-1994, 2019 Dec 10.
Artigo em Inglês | MEDLINE | ID: mdl-31690104

RESUMO

BACKGROUND: Prosthetic valve endocarditis (PVE) is a rare but critical mechanism of valve failure and death after transcatheter and surgical aortic valve replacement (TAVR, SAVR) warranting further analysis in modern aortic valve replacement experience. We characterize the incidence, risk factors, microbiological profile and outcomes of PVE from the PARTNER trials and registries (Placement of Aortic Transcatheter Valve). METHODS: We analyzed a pooled cohort of all patients in PARTNER 1 and PARTNER 2 trials and registries. Patients had severe aortic stenosis, were treated with TAVR or SAVR, and were analyzed with respect to development of PVE. PVE adjudication by a clinical events committee was based on modified Duke Criteria. The incidence, infection timing, organism, and association between PVE and all-cause mortality were analyzed. RESULTS: 8530 patients were included. PVE occurred in 107 cases (5.06 PVE events per 1000 person-years over a mean follow-up of 2.69±1.55 years [95% CI, 4.19-6.12]). The incidence of TAVR-PVE (5.21 PVE per 1000 person-years [95% CI, 4.26-6.38]) was not significantly different from SAVR-PVE (4.10 per 1000 person-years [95% CI, 2.33-7.22]; incident rate ratio, 1.27 [95% CI, 0.70-2.32]; P=0.44). Temporal risk of PVE was similar for TAVR and SAVR, even after adjusting for competing risk of death (hazard ratio, 1.15 [95% CI, 0.58-2.28]; P=0.69). Through multivariable analysis, PVE was associated with baseline cirrhosis (incident rate ratio, 2.86 [95% CI, 1.33-6.16]; P=0.007), pulmonary disease (incident rate ratio, 1.70 [95% CI, 1.16-2.48]; P=0.006), and renal insufficiency (incident rate ratio, 1.71 [95% CI, 1.03-2.83]; P=0.04). Timing of PVE was similar between TAVR and SAVR (<30 days: 4.2% vs 8.3%; 31 days to 1 year: 52.6% vs 66.7%; >1 year: 43.2% vs 25.0%; P=0.28). Staphylococcus occurred more commonly after SAVR (58.3% vs 28.4% in TAVR; P=0.04). PVE was strongly associated with all-cause mortality after endocarditis diagnosis (hazard ratio, 4.4 [95% CI, 3.42-5.72]; P<0.0001). CONCLUSIONS: The widespread adoption of TAVR and application to lower-risk patients makes understanding mechanisms of valve failure increasingly important. PVE is an established mechanism of prosthetic valve failure post-SAVR and TAVR with unclear differences between approaches. We herein demonstrate in the largest trials and registries of TAVR that PVE remains rare, but often fatal, in modern AVR experience and that there is no difference in incidence, predictors, or risk of PVE between TAVR and SAVR. CLINICAL TRIAL REGISTRATION: https://www.clinicaltrials.gov. Unique identifiers: NCT00530894 (PARTNER 1), NCT01314313 (PARTNER 1IA), NCT02184442 (PARTNER 1IB), NCT03222141 (PII S3HR), NCT03222128 (PII S3i).

16.
JAMA Cardiol ; 2019 Nov 20.
Artigo em Inglês | MEDLINE | ID: mdl-31746963

RESUMO

Importance: Pulmonary hypertension (pHTN) is associated with increased risk of mortality after mitral valve surgery for mitral regurgitation. However, its association with clinical outcomes in patients undergoing transcatheter mitral valve repair (TMVr) with a commercially available system (MitraClip) is unknown. Objective: To assess the association of pHTN with readmissions for heart failure and 1-year all-cause mortality after TMVr. Design, Setting, and Participants: This retrospective cohort study analyzed 4071 patients who underwent TMVr with the MitraClip system from November 4, 2013, through March 31, 2017, across 232 US sites in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry. Patients were stratified into the following 4 groups based on invasive mean pulmonary arterial pressure (mPAP): 1103 with no pHTN (mPAP, <25 mm Hg [group 1]); 1399 with mild pHTN (mPAP, 25-34 mm Hg [group 2]); 1011 with moderate pHTN (mPAP, 35-44 mm Hg [group 3]); and 558 with severe pHTN (mPAP, ≥45 mm Hg [group 4]). Data were analyzed from November 4, 2013, through March 31, 2017. Interventions: Patients were stratified into groups before TMVr, and clinical outcomes were assessed at 1 year after intervention. Main Outcomes and Measures: Primary end point was a composite of 1-year mortality and readmissions for heart failure. Secondary end points were 30-day and 1-year mortality and readmissions for heart failure. Linkage to Centers for Medicare & Medicaid Services administrative claims was performed to assess 1-year outcomes in 2381 patients. Results: Among the 4071 patients included in the analysis, the median age was 81 years (interquartile range, 73-86 years); 1885 (46.3%) were women and 2186 (53.7%) were men. The composite rate of 1-year mortality and readmissions for heart failure was 33.6% (95% CI, 31.6%-35.7%), which was higher in those with pHTN (27.8% [95% CI, 24.2%-31.5%] in group 1, 32.4% [95% CI, 29.0%-35.8%] in group 2, 36.0% [95% CI, 31.8%-40.2%] in group 3, and 45.2% [95% CI, 39.1%-51.0%] in group 4; P < .001). Similarly, 1-year mortality (16.3% [95% CI, 13.4%-19.5%] in group 1, 19.8% [95% CI, 17.0%-22.8%] in group 2, 22.4% [95% CI, 18.8%-26.1%] in group 3, and 27.8% [95% CI, 22.6%-33.3%] in group 4; P < .001) increased across pHTN groups. The association of pHTN with mortality persisted despite multivariable adjustment (hazard ratio per 5-mm Hg mPAP increase, 1.05; 95% CI, 1.01-1.09; P = .02). Conclusions and Relevance: These findings suggest that pHTN is associated with increased mortality and readmission for heart failure in patients undergoing TMVr using the MitraClip system for severe mitral regurgitation. Further efforts are needed to determine whether earlier intervention before pHTN develops will improve clinical outcomes.

17.
Ann Thorac Surg ; 2019 Oct 23.
Artigo em Inglês | MEDLINE | ID: mdl-31655043

RESUMO

BACKGROUND: Due to perceived technical challenges, patients with previous surgical mitral valve repair or replacement (SMVR) have been excluded from most transcatheter aortic valve replacement (TAVR) trials. Our objective was to compare the 30-day and 1-year outcomes of TAVR in patients with and without prior SMVR. METHODS: In a retrospective review of the Society of Thoracic Surgeons (STS) and American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry, we compared 1,097 patients with prior SMVR to 46,327 without prior SMVR who underwent TAVR between November 2011 and September 2015 at 394 U.S. centers. Preoperative characteristics, procedural details, and clinical outcomes were analyzed. RESULTS: Patients with previous SMVR were younger, more often female, and had higher STS Predicted Risk of Mortality (8.6% vs. 6.8%, p<0.001). However, there was no difference in 30-day mortality (4.6% vs. 5.5%, p=0.29), myocardial infarction, stroke, re-intervention, new dialysis, or readmission. Moderate/severe paravalvular leak (PVL) at discharge was also similar (5.8% vs. 4.9%, p=0.34). At 1 year, morbidity was similar but there was a trend toward higher mortality in those with prior SMVR (20.0% vs. 17.5%, p=0.09) that was significant after adjustment (HR 1.18, p=0.04). The type of prior SMVR (repair, bioprosthetic replacement, or mechanical replacement) had no impact on 30-day or 1-year survival. CONCLUSIONS: Patients with prior SMVR undergoing TAVR had similar 30-day outcomes, slightly higher 1-year mortality, and no increase in early PVL compared to those without previous SMVR. Prior SMVR should not preclude TAVR in appropriately selected patients.

18.
J Am Coll Cardiol ; 74(23): 2833-2842, 2019 Dec 10.
Artigo em Inglês | MEDLINE | ID: mdl-31577923

RESUMO

BACKGROUND: In patients with severe aortic stenosis (AS) at low surgical risk, treatment with transcatheter aortic valve replacement (TAVR) results in lower rates of death, stroke, and rehospitalization at 1 year compared with surgical aortic valve replacement; however, the effect of treatment strategy on health status is unknown. OBJECTIVES: This study sought to compare health status outcomes of TAVR versus surgery in low-risk patients with severe AS. METHODS: Between March 2016 and October 2017, 1,000 low-risk patients with AS were randomized to transfemoral TAVR using a balloon-expandable valve or surgery in the PARTNER 3 (Placement of Aortic Transcatheter Valves) trial. Health status was assessed at baseline and 1, 6, and 12 months using the KCCQ (Kansas City Cardiomyopathy Questionnaire), SF-36 (Short Form-36 Health Survey), and EQ-5D (EuroQoL). The primary endpoint was change in KCCQ-OS (KCCQ Overall Summary) score over time. Longitudinal growth curve modeling was used to compare changes in health status between treatment groups over time. RESULTS: At 1 month, TAVR was associated with better health status than surgery (mean difference in KCCQ-OS 16.0 points; p < 0.001). At 6 and 12 months, health status remained better with TAVR, although the effect was reduced (mean difference in KCCQ-OS 2.6 and 1.8 points respectively; p < 0.04 for both). The proportion of patients with an excellent outcome (alive with KCCQ-OS ≥75 and no significant decline from baseline) was greater with TAVR than surgery at 6 months (90.3% vs. 85.3%; p = 0.03) and 12 months (87.3% vs. 82.8%; p = 0.07). CONCLUSIONS: Among low-risk patients with severe AS, TAVR was associated with meaningful early and late health status benefits compared with surgery.

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