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1.
J Am Coll Cardiol ; 75(17): 2099-2106, 2020 May 05.
Artigo em Inglês | MEDLINE | ID: mdl-32194195

RESUMO

BACKGROUND: In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial, transcatheter mitral valve repair (TMVr) with the MitraClip rapidly improved health status and reduced the long-term risks for death and heart failure (HF) hospitalization in patients with HF and severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated guideline-directed medical therapy (GDMT). OBJECTIVES: The aim of this study was to examine if early health status changes were associated with long-term clinical outcomes in the COAPT population. METHODS: The association between change in health status (Kansas City Cardiomyopathy Questionnaire overall summary score [KCCQ-OS]) from baseline to 1 month and the composite rate of death or HF hospitalization between 1 month and 2 years in the COAPT trial were evaluated, and whether treatment (TMVr or GDMT alone) modified this association was tested. RESULTS: Among 551 patients with HF and severe secondary mitral regurgitation who were alive at 1 month, those randomized to TMVr were more likely than those randomized to GDMT alone to achieve a ≥10-point improvement in KCCQ-OS from baseline to 1 month (TMVr, 58%; GDMT alone, 26%). Early improvement in KCCQ-OS was inversely associated with the risk for death or HF hospitalization between 1 month and 2 years (p < 0.001). When analyzed as a continuous variable, a 10-point increase in KCCQ-OS was associated with a 14% lower risk for death or HF hospitalization (hazard ratio: 0.86; 95% confidence interval: 0.81 to 0.92; p < 0.001), with no significant interaction with treatment group (pinteraction = 0.17). After adjusting for demographic and clinical factors, the association between change in KCCQ-OS and outcomes was strengthened (hazard ratio: 0.79; 95% confidence interval: 0.73 to 0.86; p < 0.001). CONCLUSIONS: In patients with HF and severe secondary mitral regurgitation, a short-term change in disease-specific health status was strongly associated with the subsequent long-term risk for death or HF hospitalization. These findings reinforce the prognostic utility of serial KCCQ-OS assessments to identify patients at risk for poor long-term clinical outcomes in this population. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial]; NCT01626079).

2.
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.

4.
J Am Heart Assoc ; 9(4): e013168, 2020 Feb 18.
Artigo em Inglês | MEDLINE | ID: mdl-32063125

RESUMO

Background Recurrent hospitalization is prevalent in women with signs and symptoms of ischemia and no obstructive coronary artery disease. We hypothesized that rates of angina hospitalization might have changed over time, given advances in diagnostic and therapeutic approaches. Methods and Results We evaluated 551 women enrolled in the WISE (Women's Ischemia Syndrome Evaluation) study with no obstructive coronary artery disease (CAD) for a follow-up period of 9.1 years. We analyzed angina hospitalization rates using the Kaplan-Meier method. Univariate analysis and multivariable Cox proportional hazard models were developed for prediction of angina hospitalization in women with signs and symptoms of angina and no CAD. A total of 223 women had nonobstructive CAD (>20-50%

5.
Catheter Cardiovasc Interv ; 95(3): 349-354, 2020 Feb 15.
Artigo em Inglês | MEDLINE | ID: mdl-31131978

RESUMO

OBJECTIVES: To compare transesophageal echocardiography (TOE) findings after patent foramen ovale (PFO) closure by BioSTAR (NMT Medical Inc, Boston, MA) and Amplatzer PFO occluders (Abbott Vascular, Plymouth, MN). BACKGROUND: PFO closure with a biodegradable device represents an attractive alternative to permanent devices. Long-term effectiveness and morphology after biodegradation remain unknown. METHODS: Between February 2008 and June 2014, 49 patients received BioSTAR and 48 Amplatzer PFO occluder. TOE was performed after closure, at 6 months and beyond 2 years. RESULTS: PFO features were comparable between the groups. Immediate effective closure (<5 bubbles on Valsalva) was obtained in 96% by BioSTAR and 88% by Amplatzer PFO occluder (p = .16). Except for transient fever after BioSTAR (10.8 vs. 0%; p = .08), there was no adverse events. TOE at 6 months revealed comparable effective closure (93 vs. 89%; p = .74), all devices in correct position and no thrombus/pericardial effusion. In the BioSTAR group, a peri-device left-to-right color Doppler shunt was documented in one patient (2.2%), protrusion of the nitinol framework strut(s) into the atrial cavity in two patients (4.3%), and both events in one patient (2.2%). TOE beyond 2 years showed comparable effective closure (92 vs. 96%; p = 1.00) and again BioSTAR-associated peri-device left-to-right shunt and metal framework strut(s) protrusion. There was no stroke or peripheral embolization in either group while TIA was numerically greater in BioSTAR patients (6.8 vs. 2.5%; p = .61). CONCLUSION: BioSTAR provided similar PFO closure rate as Amplatzer PFO occluder. As yet unreported BioSTAR-associated peri-device left-to-right shunt and metal framework strut(s) protrusion may have practical implications for further development of biodegradable devices.

6.
J Am Coll Cardiol ; 74(23): 2878-2889, 2019 Dec 10.
Artigo em Inglês | MEDLINE | ID: mdl-31806131

RESUMO

BACKGROUND: Long-term data on the safety and efficacy of left atrial appendage closure (LAAC) for stroke prevention in patients with nonvalvular atrial fibrillation remain limited. OBJECTIVES: The purpose of this study was to evaluate 4.5- to 5-year data in 2 U.S. Food and Drug Association LAAC mandated registries (CAP [Continued Access to PROTECT-AF] and CAP2 [Continued Access to PREVAIL]) for safety and efficacy. METHODS: Two registries of patients implanted with LAAC devices provide the largest source of follow-up data. Both accompanied their respective randomized clinical trials, PROTECT-AF (Watchman Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation) and PREVAIL (Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device In Patients with Atrial Fibrillation versus Long Term Warfarin Therapy), which used the same endpoints (primary efficacy of composite of stroke, systemic embolism, cardiovascular/unexplained death, and safety). RESULTS: CAP included 566 patients with an average follow-up of 50.1 months (2,293 patient-years), and CAP2 included 578 patients with an average follow-up of 50.3 months (2,227 patient-years). CAP2 patients were significantly older and had higher CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke/transient ischemic attack, vascular disease, age 65 to 74 years, sex category) scores (4.51 vs. 3.88; p < 0.001). Procedural success was similar in both (94%). The primary composite endpoint occurred at a rate of 3.05 per 100 patient-years in CAP and 4.80 per 100 patient-years in CAP2; events contributing to this endpoint were most commonly cardiovascular/unexplained death (1.69 per 100 patient-years for CAP and 2.92 per 100 patient-years for CAP2). Hemorrhagic stroke was significantly less than ischemic stroke (0.17 per 100 patient-years in CAP and 0.09 per 100 patient-years in CAP2), and total stroke rates were significantly less than predicted by CHA2DS2-VASc score (78% reduction with CAP, 69% reduction with CAP2). CONCLUSIONS: These registries, which contain the longest and largest follow-up data of patients with the Watchman device, support LAAC as a safe and effective therapy for long-term anticoagulation in patients with nonvalvular atrial fibrillation, and document the lowest rate of hemorrhagic stroke identified in this population.

8.
Artigo em Inglês | MEDLINE | ID: mdl-31823234

RESUMO

BACKGROUND: Left atrial (LA) strain and strain rate (SR) analysis by two-dimensional speckle tracking echocardiography is a novel way of LA function assessment. From prior study, we know that LA appendage closure with LARIAT appears to improve LA function. OBJECTIVE: The purpose of this study was to assess the impact of LAA closure via Watchman device on LA function via strain and volumetric analyses using two-dimensional speckle tracking echocardiography (2D-STE). METHODS: Twenty-five patients who underwent Watchman device implantation (WDI) were included. LA function parameters (volumetric, strain indices) were calculated from apical four chamber views with the reference point set at QRS using 2D-STE before and after WDI. LA expansion index, strain and strain rate during ventricular systole represent LA reservoir function. Passive emptying fraction, strain and strain rate during early ventricular diastole represent LA conduit function. RESULTS: Mean age was 76 ± 6.9 years with 60% males. There was significant improvement in conduit function (LA passive emptying fraction; post 28.6 (21.9-35.9) vs pre 21.0 (13.8-34.7), p = 0.032), reservoir function (LA expansion index; post 75.3 (52.3-98.0) vs pre 58.1 (37.8-85.2), p = 0.026), and booster function (LA active emptying fraction; post 13.3 (9.7-29.9) vs pre 12.6 (8.8-25.5), p = 0.04) by volumetric indices. No significant improvement was noted with strain indices in conduit function (SRe; post - 0.56 (0.43-0.93) vs pre - 0.58 (0.46-0.87); p = 0.518) and reservoir function (SRs; post + 0.58 (0.28-0.40) vs pre + 0.52 (0.35-0.86); p = 0.851). CONCLUSIONS: WDI resulted in discrepancy of volumetric and strain indices in LA function assessment.

9.
J Interv Cardiol ; 2019: 7169275, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31772544

RESUMO

Objective: In a separate, contemporary cohort, we sought to confirm findings of the original Women's Ischemia Syndrome Evaluation (WISE). Background: The original WISE observed a high prevalence of both invasively determined coronary endothelial and coronary microvascular dysfunction (CMD) that predicted adverse events in follow-up. Methods: We comparatively studied the WISE-Coronary Vascular Dysfunction (CVD) cohort (2009-2011), with signs and symptoms of ischemia but without significant CAD, to the original WISE (1997-2001) cohort. CMD was defined as coronary flow reserve (CFR) ≤2.5, or endothelial dysfunction as epicardial coronary artery constriction to acetylcholine (ACH), or <20% epicardial coronary dilation to nitroglycerin (NTG). Results: In WISE (n=181) and WISE-CVD (n=235) women, mean age in both was 54 years, and 83% were white (WISE) vs 74% (WISE-CVD, p=0.04). Use of hormone replacement therapy was less frequent in WISE-CVD vs WISE (46% vs 57%, p=0.026) as was presence of hypertension (40% vs 52%, p=0.013), hyperlipidemia (20% vs 46%, p<0.0001), and smoking (46% vs 56%, p=0.036). Similar rates were observed in WISE-CVD and WISE cohorts for CMD (mean CFR 2.7±0.6 vs 2.6±0.8, p=0.35), mean change in diameter with intracoronary ACH (0.2±10.0 vs 1.6±12.8 mm, p=0.34), and mean change in diameter with intracoronary NTG (9.7±13.0 vs 9.8±13.5 mm, p=0.94), respectively. Conclusions: This study confirms prevalence of CMD in the contemporary WISE-CVD cohort similar to that of the original WISE cohort, despite a lower risk factor burden in WISE-CVD. Because these coronary functional abnormalities predict major adverse cardiac events, clinical trials of therapies targeting these abnormalities are indicated.


Assuntos
Endotélio Vascular/fisiopatologia , Microvasos/fisiopatologia , Isquemia Miocárdica , Estudos de Coortes , Angiografia Coronária/métodos , Vasos Coronários/fisiopatologia , Feminino , Humanos , Pessoa de Meia-Idade , Isquemia Miocárdica/diagnóstico , Isquemia Miocárdica/epidemiologia , Isquemia Miocárdica/fisiopatologia , National Heart, Lung, and Blood Institute (U.S.) , Prognóstico , Fatores de Risco , Estados Unidos/epidemiologia
10.
J Am Coll Cardiol ; 74(18): 2267-2274, 2019 Nov 05.
Artigo em Inglês | MEDLINE | ID: mdl-31672183

RESUMO

BACKGROUND: Direct current cardioversion (DCCV) is a common rhythm control strategy in patients with symptomatic atrial fibrillation or flutter. There is no long-term data regarding the safety of DCCV in patients with endocardial left atrial appendage occlusion (LAAO) devices. OBJECTIVES: The purpose of this study was to assess the feasibility and safety of DCCV in patients with an LAAO device. METHODS: This multicenter retrospective study included 148 patients with an LAAO device who underwent DCCV for symptomatic atrial fibrillation or atrial flutter. RESULTS: The average age of the included patients was 72 ± 7 years and 59% were men. All patients (100%) had a transesophageal echocardiogram prior to DCCV. Device-related thrombus was seen in 2.7%. They were all successfully treated with oral anticoagulation (OAC) and were able to undergo DCCV after 6 to 8 weeks. DCCV restored sinus rhythm in all patients. None of the patients had DCCV-related thromboembolic complications. A total of 22% of patients were newly started on OAC after DCCV. There was no difference in DCCV-related complications between patients treated with or without OAC post-DCCV. Patients receiving OAC post-DCCV were found to undergo cardioversion at an earlier time after implantation (3.6 months [interquartile range (IQR): 0.7 to 8.6 months] vs. 8.6 months [IQR: 2.5 to 13.3 months]; p = 0.003). Three transient ischemic attacks, unrelated to DCCV, were found during follow-up. During a median follow-up of 12.8 months (IQR: 11.8 to 14.2 months), no device or left atrial thrombosis, device dislodgement, or a new device leak were observed. One patient died during follow-up due to noncardiac cause. CONCLUSIONS: DCCV is feasible in high-risk AF patients with an LAAO device without the need for oral anticoagulation if pre-procedural transesophageal echocardiography shows good device position, absence of device-related thrombus, and peridevice leak of ≤5 mm. The preliminary results are encouraging, but further large studies are warranted to establish safety.

11.
Artigo em Inglês | MEDLINE | ID: mdl-31605479

RESUMO

AIMS: We sought to find the morphological mechanisms of recurrent mitral regurgitation (MR) after MitraClip procedure using 3D transoesophageal echocardiography (TOE). METHODS AND RESULTS: Of 478 consecutive patients treated with the initial MitraClip procedure, 41 patients who underwent repeat mitral valve (MV) transcatheter or surgical intervention for recurrent MR were retrospectively reviewed. Using 3D-TOE, we investigated morphological changes of MV leading to repeat MV intervention. Aetiology of MR at the index intervention was primary in 24 (59%) and secondary in 17 (41%) patients. In the primary MR group, worsening leaflet prolapse at the clip site caused recurrent MR in 12 (50%) patients, while 7 (29%) patients had a leaflet tear at the clip site. Acute single leaflet device detachment was seen in four patients and one patient had recurrent MR between the plug and the clip. In secondary MR, left ventricular (LV)/left atrial dilation caused recurrent MR in 13 (76%) patients. Significant increase in the LV end-diastolic volume and tenting height were observed from post-index procedure to repeat intervention (LV end-diastolic volume; from 205 to 237 ml, P < 0.001, tenting height; from 0.8 to 1.3 cm, P < 0.001). New emergent leaflet prolapse/flail was seen in 3 (18%) patients, suggesting iatrogenic MR. CONCLUSION: Mechanisms of recurrent MR after MitraClip procedure varied and depended on the underlying MV pathology: in primary MR, worsening mitral leaflet prolapse and in secondary MR, progressive LV dilation with worsening tenting were the main causes of recurrent MR.

12.
J Am Coll Cardiol ; 74(24): 2969-2979, 2019 Dec 17.
Artigo em Inglês | MEDLINE | ID: mdl-31574303

RESUMO

BACKGROUND: In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial among patients with heart failure (HF) and moderate-to-severe (3+) or severe (4+) secondary mitral regurgitation, patients treated with transcatheter mitral valve repair (TMVr) through leaflet approximation had reduced rates of HF hospitalization and mortality compared with guideline-directed medical therapy (GDMT) alone. OBJECTIVES: The purpose of this study was to describe the echocardiographic patient qualification process for the COAPT trial, baseline echocardiographic characteristics, changes over time, and the interaction between treatment group and echocardiographic parameters on clinical outcomes. METHODS: A novel echocardiographic algorithm was implemented for grading mitral regurgitation severity during the screening process. Standardized echocardiograms were obtained at baseline and during regular follow-up intervals through 2 years, and were analyzed by a core laboratory. RESULTS: A total of 614 patients were randomized to TMVr plus maximally tolerated GDMT or GDMT alone. Mean baseline left ventricular (LV) ejection fraction was 31.3 ± 9.3%, LV end-diastolic volume was 192.7 ± 71 ml, and effective regurgitant orifice area was 0.41 ± 0.15 cm2. The beneficial effect of TMVr compared with GDMT alone was consistent in all echocardiographic subgroups, independent of the severity of LV dysfunction, LV dilatation, pulmonary hypertension, severity of tricuspid regurgitation, or individual mitral regurgitation characteristics. The LV ejection fraction decreased and the LV volumes progressively increased in both groups during follow-up, although less after TMVr (p < 0.05). CONCLUSIONS: HF patients in the COAPT trial with 3+ or 4+ secondary mitral regurgitation, selected using strict echocardiographic criteria, benefitted from TMVr with reduced 2-year rates of death and HF hospitalization. Strict application of these echocardiographic criteria should enable the COAPT results to be translated to clinical practice. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] [COAPT]; NCT01626079).

13.
JACC Cardiovasc Interv ; 12(23): 2402-2412, 2019 Dec 09.
Artigo em Inglês | MEDLINE | ID: mdl-31629753

RESUMO

OBJECTIVES: This study proposes a physiologic assessment of left ventricular outflow tract obstruction (LVOTO) that accommodates changes in systolic flow and accounts for the dynamic neo-left ventricular outflow tract (LVOT). BACKGROUND: Patients considered for transcatheter mitral valve replacement trials often screen-fail because of the perceived risk of LVOTO. In the Intrepid Global Pilot Study, assumed risk of LVOTO was based on computed tomography estimates of the neo-LVOT area computed at end-systole. However, this may overestimate actual risk. METHODS: Retrospective analyses were performed for screen-failed patients for potential LVOTO (n = 33) and treated patients (n = 29) with available dynamic computed tomography. A multiphase assessment of the neo-LVOT area was performed and represented as: 1) multiphase average; and 2) early systolic value. Prospective evaluation was performed in 9 patients approved for enrollment with multiphase and early systole methods that would have previously screen-failed with the end-systolic approach. RESULTS: Of 166 patients screened for possible inclusion; 32 were screen-failed for nonanatomical reasons. Screen failure for assumed LVOTO risk occurred in 37 of 134 (27.6%) patients. Retrospective analysis indicated a potential enrollment increase of 11 of 33 (33.3%) and 18 of 33 (54.5%) patients using multiphase and early systolic assessment methods. In the prospective cohort, there were no clinical observations of LVOTO 30 days post-procedure, despite assumed risk based on end-systolic estimates. CONCLUSIONS: Multiphase, and specifically early systolic, assessment of the neo-LVOT may better determine risk of LVOTO with transcatheter mitral valve replacement compared with end-systolic estimates. This novel approach has the potential to significantly increase patient eligibility, with over one-half of patients previously screen-failed now eligible for treatment.

14.
EuroIntervention ; 15(6): e482-e483, 2019 Aug 09.
Artigo em Inglês | MEDLINE | ID: mdl-31395574
15.
JACC Cardiovasc Interv ; 12(14): 1342-1352, 2019 Jul 22.
Artigo em Inglês | MEDLINE | ID: mdl-31320029

RESUMO

OBJECTIVES: The aim of this study was to examine the relation between institutional experience and procedural results of transcatheter mitral valve repair. BACKGROUND: Transcatheter mitral valve repair for the treatment of mitral regurgitation (MR) is a complex procedure requiring navigation of the left atrium, left ventricle, and mitral valve apparatus using echocardiographic guidance. METHODS: MitraClip procedures from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry were stratified into tertiles on the basis of site-specific case sequence (1 to 18, 19 to 51, and 52 to 482). In-hospital outcomes of procedural success, procedural time, and procedural complications were examined. To evaluate the learning curve for the procedure, generalized linear mixed models were developed using case sequence number as a continuous variable. RESULTS: MitraClip procedures (n = 12,334) performed at 275 sites between November 2013 and September 2017 were analyzed. Optimal procedural success (≤1+ residual MR without mortality or need for cardiac surgery) increased across tertiles of case experience (62.0%, 65.5%, and 72.5%; p < 0.001), whereas procedural time and procedural complications decreased. Acceptable procedural success (≤2+ residual MR without death or need for cardiac surgery) also increased across tertiles of case experience, but the differences were smaller (91.2%, 91.2%; and 92.9%; p = 0.006). In the learning-curve analysis, visual inflection points for procedural time, procedural success, and procedural complications were evident after about 50 cases, with continued improvements observed up to 200 cases. CONCLUSIONS: For transcatheter mitral valve repair with the MitraClip, increasing institutional experience was associated with improvements in procedural success, procedure time, and procedural complications. The impact of institutional experience was larger when considering the goal of achieving optimal MR reduction.

16.
JACC Cardiovasc Interv ; 12(14): 1369-1378, 2019 Jul 22.
Artigo em Inglês | MEDLINE | ID: mdl-31255562

RESUMO

OBJECTIVES: The authors report the procedural and 30-day results of the PASCAL Transcatheter Valve Repair System (Edwards Lifesciences, Irvine, California) in patients with mitral regurgitation (MR) enrolled in the multicenter, prospective, single-arm CLASP study. BACKGROUND: Severe MR may lead to symptoms, impaired quality of life, and reduced functional capacity when untreated. METHODS: Eligible patients had grade 3+ or 4+ MR despite optimal medical therapy and were deemed appropriate for the study by the local heart team. All outcomes were assessed through 30 days post-procedure. Major adverse events (MAEs) were adjudicated by an independent clinical events committee, and echocardiographic images were assessed by a core laboratory. The primary safety endpoint was the rate of MAEs at 30 days. RESULTS: Between June 2017 and September 2018, 62 patients with grade 3+ or 4+ MR were enrolled. The mean age was 76.5 years, and 51.6% of patients were in New York Heart Association functional class III or IV, with 56% functional, 36% degenerative, and 8% mixed MR etiology. At 30 days, the MAE rate was 6.5%, with an all-cause mortality rate of 1.6% and no occurrence of stroke; 98% had MR grade ≤2+, with 86% with MR grade ≤1+ (p < 0.0001); and 85% were in New York Heart Association functional class I or II (p < 0.0001). Six-minute walk distance improved by 36 m (p = 0.0018), and Kansas City Cardiomyopathy Questionnaire and EQ-5D scores improved by 17 (p < 0.0001) and 10 (p = 0.0004) points, respectively. CONCLUSIONS: The PASCAL repair system showed feasibility and acceptable safety in the treatment of patients with grade 3+ or 4+ MR. MR severity, irrespective of etiology, was significantly reduced and accompanied by clinically and statistically significant improvements in functional status, exercise capacity, and quality of life. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study; NCT03170349).

17.
JACC Cardiovasc Interv ; 12(11): 1055-1063, 2019 Jun 10.
Artigo em Inglês | MEDLINE | ID: mdl-31171282

RESUMO

OBJECTIVES: In this propensity-matched analysis of post-left atrial appendage closure antithrombotic therapy, the safety and effectiveness of oral anticoagulation (OAC) and antiplatelet therapy (APT) were compared. BACKGROUND: Left atrial appendage closure with the WATCHMAN device is an alternative to OAC in patients with nonvalvular atrial fibrillation, who are at high bleeding risk. Initial trials included 45 days of post-implantation OAC, but registry data suggest that APT may suffice. METHODS: Patients from the PROTECT-AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation), PREVAIL (Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy), CAP (Continued Access to PROTECT-AF), CAP2 (Continued Access to PREVAIL), ASAP (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology), and EWOLUTION (Registry on WATCHMAN Outcomes in Real-Life Utilization) trials receiving either OAC or APT post-implantation were matched and compared for nonprocedural bleeding and stroke or systemic thromboembolism over 6 months following implantation. Each patient on APT was matched with 2 patients on OAC, with propensity scores derived from age, sex, congestive heart failure, hypertension, diabetes, prior transient ischemic attack or stroke, peripheral vascular disease, left ventricular ejection fraction, renal impairment, and different atrial fibrillation subtypes. RESULTS: The cohort on OAC (n = 1,018; 95% receiving warfarin and 5% receiving nonwarfarin OAC) was prescribed 45-day OAC post-implantation (92% also received single APT), followed by 6-month single or dual APT. The cohort on APT (n = 509; 91% receiving dual APT and 9% receiving single APT) received APT for variable durations. Six-month freedom from nonprocedural major bleeding was similar (OAC, 95.7%; APT, 95.5%; p = 0.775) despite more early bleeds with OAC. Freedom from thromboembolism beyond 7 days was similar between groups (OAC, 98.8%; APT, 99.4%; p = 0.089). However, device-related thrombosis was more frequent with APT (OAC, 1.4%; APT, 3.1%; p = 0.018). CONCLUSIONS: After left atrial appendage closure with the WATCHMAN, although device-related thrombosis was more common with APT, both APT and OAC strategies resulted in similar safety and efficacy endpoints.

19.
J Am Coll Cardiol ; 73(17): 2123-2132, 2019 05 07.
Artigo em Inglês | MEDLINE | ID: mdl-30894288

RESUMO

BACKGROUND: In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, transcatheter mitral valve repair (TMVr) led to reduced heart failure (HF) hospitalizations and improved survival in patients with symptomatic HF and 3+ to 4+ secondary mitral regurgitation (MR) on maximally-tolerated medical therapy. Given the advanced age and comorbidities of these patients, improvement in health status is also an important treatment goal. OBJECTIVES: The purpose of this study was to understand the health status outcomes of patients with HF and 3+ to 4+ secondary MR treated with TMVr versus standard care. METHODS: The COAPT trial randomized patients with HF and 3+ to 4+ secondary MR to TMVr (n = 302) or standard care (n = 312). Health status was assessed at baseline and at 1, 6, 12, and 24 months with the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the SF-36 health status survey. The primary health status endpoint was the KCCQ overall summary score (KCCQ-OS; range 0 to 100; higher = better; minimum clinically important difference = 5 points). RESULTS: At baseline, patients had substantially impaired health status (mean KCCQ-OS 52.4 ± 23.0). While health status was unchanged over time in the standard care arm, patients randomized to TMVr demonstrated substantial improvement in the KCCQ-OS at 1 month (mean between-group difference 15.9 points; 95% confidence interval [CI]: 12.3 to 19.5 points), with only slight attenuation of this benefit through 24 months (mean between-group difference 12.8 points; 95% CI: 7.5 to 18.2 points). At 24 months, 36.4% of TMVr patients were alive with a moderately large (≥10-point) improvement versus 16.6% of standard care patients (p < 0.001), for a number needed to treat of 5.1 patients (95% CI: 3.6 to 8.7 patients). TMVr patients also reported better generic health status at each timepoint (24-month mean difference in SF-36 summary scores: physical 3.6 points; 95% CI: 1.4 to 5.8 points; mental 3.6 points; 95% CI: 0.8 to 6.4 points). CONCLUSIONS: Among patients with symptomatic HF and 3+ to 4+ secondary MR receiving maximally-tolerated medical therapy, edge-to-edge TMVr resulted in substantial early and sustained health status improvement compared with medical therapy alone. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] [COAPT]; NCT01626079).

20.
JACC Cardiovasc Interv ; 12(2): 140-150, 2019 01 28.
Artigo em Inglês | MEDLINE | ID: mdl-30678793

RESUMO

OBJECTIVES: The aim of this study was to determine the prognostic value of pulmonary venous (PV) flow during MitraClip implantation. BACKGROUND: The clinical significance of PV flow information during MitraClip implantation is unknown. METHODS: A total of 300 patients who underwent MitraClip implantation and in whom the measurement of PV flow was completed using intraprocedural transesophageal echocardiography were retrospectively reviewed. The optimal threshold of the ratio of systolic velocity-time integral (Svti) to diastolic velocity-time integral (Dvti) ratio after MitraClip placement for major adverse cardiovascular events (all-cause death, redo MitraClip implantation, mitral valve surgery, and heart transplantation) during 12 months was assessed. The best cutoff ratio was 0.72. Patients were divided into 2 groups using this cutoff ratio (low Svti/Dvti, n = 91; high Svti/Dvti, n = 209). RESULTS: Following mitral regurgitation reduction by MitraClip placement, Svti increased in the both groups. The frequency of mitral regurgitation 3/4+ immediately after MitraClip implantation, at 1-month follow-up, and at 12-month follow-up was significantly higher in patients with low Svti/Dvti ratios than in those with high Svti/Dvti ratios (after MitraClip placement, 5.5% vs. 0%; p < 0.001; at 1 month; 26% vs. 5.2%; p < 0.001; at 12 months, 18% vs. 5.3%; p = 0.006). Major adverse cardiovascular events during 12 months were significantly higher in patients with low Svti/Dvti ratios than in those with high Svti/Dvti ratios (23% vs. 6.2%; p < 0.001). Multivariate analysis demonstrated that low Svti/Dvti ratio was significantly associated with major adverse cardiovascular events during 12 months after adjustment for age, baseline renal function, and mean transmitral pressure gradient (adjusted hazard ratio: 4.00; 95% confidence interval: 2.02 to 8.23; p < 0.001). CONCLUSIONS: PV flow information in the catheterization laboratory immediately after MitraClip implantation predicted recurrent mitral regurgitation and worse long-term outcomes.


Assuntos
Cateterismo Cardíaco/instrumentação , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Hemodinâmica , Insuficiência da Valva Mitral/cirurgia , Valva Mitral/cirurgia , Monitorização Intraoperatória/métodos , Circulação Pulmonar , Veias Pulmonares/fisiopatologia , Idoso , Idoso de 80 Anos ou mais , Cateterismo Cardíaco/efeitos adversos , Bases de Dados Factuais , Ecocardiografia Transesofagiana , Feminino , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Valva Mitral/diagnóstico por imagem , Valva Mitral/fisiopatologia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/fisiopatologia , Valor Preditivo dos Testes , Desenho de Prótese , Recuperação de Função Fisiológica , Recidiva , Reoperação , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
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