Abstract Background In the PROTECT AF (Watchman Left Atrial Appendage Closure Technology for Embolic Protection in Patients With Atrial Fibrillation) trial that evaluated patients with nonvalvular ...atrial fibrillation (NVAF), left atrial appendage (LAA) occlusion was noninferior to warfarin for stroke prevention, but a periprocedural safety hazard was identified. Objectives The goal of this study was to assess the safety and efficacy of LAA occlusion for stroke prevention in patients with NVAF compared with long-term warfarin therapy. Methods This randomized trial further assessed the efficacy and safety of the Watchman device. Patients with NVAF who had a CHADS2 (congestive heart failure, hypertension, age >75 years, diabetes mellitus, and previous stroke/transient ischemic attack) score ≥2 or 1 and another risk factor were eligible. Patients were randomly assigned (in a 2:1 ratio) to undergo LAA occlusion and subsequent discontinuation of warfarin (intervention group, n = 269) or receive chronic warfarin therapy (control group, n = 138). Two efficacy and 1 safety coprimary endpoints were assessed. Results At 18 months, the rate of the first coprimary efficacy endpoint (composite of stroke, systemic embolism SE, and cardiovascular/unexplained death) was 0.064 in the device group versus 0.063 in the control group (rate ratio 1.07 95% credible interval (CrI): 0.57 to 1.89) and did not achieve the prespecified criteria noninferiority (upper boundary of 95% CrI ≥1.75). The rate for the second coprimary efficacy endpoint (stroke or SE >7 days’ postrandomization) was 0.0253 versus 0.0200 (risk difference 0.0053 95% CrI: –0.0190 to 0.0273), achieving noninferiority. Early safety events occurred in 2.2% of the Watchman arm, significantly lower than in PROTECT AF, satisfying the pre-specified safety performance goal. Using a broader, more inclusive definition of adverse effects, these still were lower in PREVAIL (Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) trial than in PROTECT AF (4.2% vs. 8.7%; p = 0.004). Pericardial effusions requiring surgical repair decreased from 1.6% to 0.4% (p = 0.027), and those requiring pericardiocentesis decreased from 2.9% to 1.5% (p = 0.36), although the number of events was small. Conclusions In this trial, LAA occlusion was noninferior to warfarin for ischemic stroke prevention or SE >7 days’ post-procedure. Although noninferiority was not achieved for overall efficacy, event rates were low and numerically comparable in both arms. Procedural safety has significantly improved. This trial provides additional data that LAA occlusion is a reasonable alternative to warfarin therapy for stroke prevention in patients with NVAF who do not have an absolute contraindication to short-term warfarin therapy.
Abstract Background Surgical mitral valve repair (SMVR) remains the gold standard for severe degenerative mitral regurgitation (DMR). However, the results with transcatheter mitral valve repair ...(TMVR) in prohibitive-risk DMR patients have not been previously reported. Objectives This study aimed to evaluate treatment of mitral regurgitation (MR) in patients with severe DMR at prohibitive surgical risk undergoing TMVR. Methods A prohibitive-risk DMR cohort was identified by a multidisciplinary heart team that retrospectively evaluated high-risk DMR patients enrolled in the EVEREST (Endovascular Valve Edge-to-Edge Repair Study) II studies. Results A total of 141 high-risk DMR patients were consecutively enrolled; 127 of these patients were retrospectively identified as meeting the definition of prohibitive risk and had 1-year follow-up (median: 1.47 years) available. Patients were elderly (mean age: 82.4 years), severely symptomatic (87% New York Heart Association class III/IV), and at prohibitive surgical risk (STS score: 13.2 ± 7.3%). TMVR (MitraClip) was successfully performed in 95.3%; hospital stay was 2.9 ± 3.1 days. Major adverse events at 30 days included death in 6.3%, myocardial infarction in 0.8%, and stroke in 2.4%. Through 1 year, there were a total of 30 deaths (23.6%), with no survival difference between patients discharged with MR ≤1+ or MR 2+. At 1 year, the majority of surviving patients (82.9%) remained MR ≤2+ at 1 year, and 86.9% were in New York Heart Association functional class I or II. Left ventricular end-diastolic volume decreased (from 125.1 ± 40.1 ml to 108.5 ± 37.9 ml; p < 0.0001 n = 69 survivors with paired data). SF-36 quality-of-life scores improved and hospitalizations for heart failure were reduced in patients whose MR was reduced. Conclusions TMVR in prohibitive surgical risk patients is associated with safety and good clinical outcomes, including decreases in rehospitalization, functional improvements, and favorable ventricular remodeling, at 1 year. (Real World Expanded Multi-center Study of the MitraClip System REALISM; NCT01931956 )
Objectives The purpose of this study was to investigate the frequency and clinical impact of incomplete left atrial appendage (LAA) sealing and consequent peri-device residual blood flow in patients ...undergoing percutaneous LAA closure with the Watchman device (Atritech, Inc., Plymouth, Minnesota). Background During percutaneous LAA closure for stroke prophylaxis, the geometric variability of the LAA ostium may result in an incomplete seal of the LAA. On the one hand, this could enhance thrombus formation and embolization of thrombi around the device into the circulation; on the other hand, the relatively small size of these leaks may preclude clinically relevant embolizations. Methods Patients randomly assigned to device implantation in the PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial were analyzed. Transesophageal echocardiography was performed at 45 days, 6 months, and 12 months. Per the study protocol, patients discontinued warfarin therapy if the 45-day Transesophageal echocardiogram revealed either minimal or no peri-device flow (jet ≤5 mm width). The impact of peri-device flow severity, defined as minor, moderate, or major (<1 mm, 1 mm to 3 mm, >3 mm, respectively) on the composite primary efficacy endpoint (stroke, systemic embolism, and cardiovascular death) is expressed as hazard ratio (HR) with 95% confidence interval (CI). Results Transesophageal echocardiography follow-up revealed that 32.0% of implanted patients had at least some degree of peri-device flow at 12 months. The HR of the primary efficacy endpoint per 1 mm larger per-device flow was 0.84 (95% CI: 0.62 to 1.14; p = 0.256). Compared to patients with no peri-device flow, the HRs were 0.85 (95% CI: 0.11 to 6.40), 0.83 (95% CI: 0.33 to 2.09), and 0.48 (95% CI: 0.11 to 2.09) for minor, moderate, and major peri-device flow, respectively (p = 0.798). Compared to patients with no peri-device flow who discontinued warfarin, the HR for patients with any peri-device flow and continuing warfarin was 0.63 (95% CI: 0.14 to 2.71; p = 0.530). Conclusions These data indicate that residual peri-device flow into the LAA after percutaneous closure with the Watchman device was common, and is not associated with an increased risk of thromboembolism. This finding should be interpreted with caution as the low event rate decreases the confidence of this conclusion.
Abstract Background Transcatheter mitral valve (MV) repair with the MitraClip received approval in 2013 for the treatment of prohibitive-risk patients with primary mitral regurgitation (MR). ...Objectives The aim of this study was to report the initial U.S. commercial experience with transcatheter MV repair. Methods Data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry on patients commercially treated with this percutaneous mitral valve repair device were analyzed. Results Of 564 patients (56% men, median age 83 years), severe symptoms were present in 473 (86.0%). The median Society of Thoracic Surgeons Predicted Risk of Mortality scores for MV repair and replacement were 7.9% (interquartile range: 4.7% to 12.2%) and 10.0% (interquartile range: 6.3% to 14.5%), respectively. Frailty was noted in 323 patients (57.3%). Transcatheter MV repair was performed for degenerative disease, present in 90.8% of patients. Overall, MR was reduced to grade ≤2 in 93.0%. In-hospital mortality was 2.3%; 30-day mortality was 5.8%. Other 30-day events were stroke (1.8%), bleeding (2.6%), and device-related complications (1.4%). The median length of stay was 3 days (interquartile range: 1 to 6 days), with 84.0% patients discharged home. Overall, procedure success occurred in 90.6%. Variables associated with reduction in MR were end-diastolic dimension, MR severity, clip location, and case volume. Conclusions In this study of the initial commercial U.S. experience, it was found that procedural success was achieved in approximately 91% of patients, and the majority of patients were discharged home with moderate or less MR. These data support the effectiveness of this therapy in appropriately selected high-risk patients in a commercial setting. Further study is required to determine the long-term impact of transcatheter MV repair in this patient population.
Objectives The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study (HRS) assessed the safety and effectiveness of the MitraClip device (Abbott Vascular, Santa Clara, California) in ...patients with significant mitral regurgitation (MR) at high risk of surgical mortality rate. Background Patients with severe MR (3 to 4+) at high risk of surgery may benefit from percutaneous mitral leaflet repair, a potentially safer approach to reduce MR. Methods Patients with severe symptomatic MR and an estimated surgical mortality rate of ≥12% were enrolled. A comparator group of patients screened concurrently but not enrolled were identified retrospectively and consented to compare survival in patients treated by standard care. Results Seventy-eight patients underwent the MitraClip procedure. Their mean age was 77 years, >50% had previous cardiac surgery, and 46 had functional MR and 32 degenerative MR. MitraClip devices were successfully placed in 96% of patients. Protocol-predicted surgical mortality rate in the HRS and concurrent comparator group was 18.2% and 17.4%, respectively, and Society of Thoracic Surgeons calculator estimated mortality rate was 14.2% and 14.9%, respectively. The 30-day procedure-related mortality rate was 7.7% in the HRS and 8.3% in the comparator group (p = NS). The 12-month survival rate was 76% in the HRS and 55% in the concurrent comparator group (p = 0.047). In surviving patients with matched baseline and 12-month data, 78% had an MR grade of ≤2+. Left ventricular end-diastolic volume improved from 172 ml to 140 ml and end-systolic volume improved from 82 ml to 73 ml (both p = 0.001). New York Heart Association functional class improved from III/IV at baseline in 89% to class I/II in 74% (p < 0.0001). Quality of life was improved (Short Form-36 physical component score increased from 32.1 to 36.1 p = 0.014 and the mental component score from 45.5 to 48.7 p = 0.065) at 12 months. The annual rate of hospitalization for congestive heart failure in surviving patients with matched data decreased from 0.59 to 0.32 (p = 0.034). Conclusions The MitraClip device reduced MR in a majority of patients deemed at high risk of surgery, resulting in improvement in clinical symptoms and significant left ventricular reverse remodeling over 12 months. (Pivotal Study of a Percutaneous Mitral Valve Repair System EVEREST II; NCT00209274 )
Published studies of epicardial ligation of left atrial appendage (LAA) have reported discordant results.
The purpose of this study was to delineate the safety and efficacy of LAA closure with the ...LARIAT device.
This is a multicenter registry of 712 consecutive patients undergoing LAA ligation with LARIAT at 18 US hospitals. The primary end point was successful suture deployment, no leak by intraprocedural transesophageal echocardiography (TEE), and no major complication (death, stroke, cardiac perforation, and bleeding requiring transfusion) at discharge. A leak of 2-5 mm on follow-up TEE was the secondary end point.
LARIAT was successfully deployed in 682 patients (95.5%). A complete closure was achieved in 669 patients (98%), while 13 patients (1.8%) had a trace leak (<2 mm). There was 1 death related to the procedure. Ten patients (1.44%) had cardiac perforation necessitating open heart surgery, while another 14 (2.01%) did not need surgery. The risk of cardiac perforation decreased significantly after the introduction of a micropuncture (MP) needle for pericardial access. Delayed complications (pericarditis requiring >2 weeks of treatment with nonsteroidal anti-inflammatory drugs/colchicine and pericardial and pleural effusion after discharge) occurred in 34 (4.78%) patients, and the risk decreased significantly with the periprocedural use of colchicine. Follow-up TEE (n = 480) showed a leak of 2-5 mm in 6.5% and a thrombus in 2.5%. One patient had a leak of >5 mm.
LARIAT effectively closes the LAA and has acceptable procedural risks with the evolution of the use of the micropuncture needle for pericardial access and the use of colchicine for mitigating the postinflammatory response associated with LAA ligation and pericardial access.
The Acute Hemodynamic Effects of MitraClip Therapy Siegel, Robert J., MD; Biner, Simon, MD; Rafique, Asim M., MD ...
Journal of the American College of Cardiology,
04/2011, Letnik:
57, Številka:
16
Journal Article
Recenzirano
Odprti dostop
Objectives The objective of this study was to evaluate the acute hemodynamic consequences of mitral valve (MV) repair with the MitraClip device (Abbott Vascular, Menlo Park, California). Background ...Whether surgical correction of mitral regurgitation (MR) results in a low cardiac output (CO) state because of an acute increase in afterload remains controversial. The acute hemodynamic consequences of MR reduction with the MitraClip device have not been studied. Methods We evaluated 107 patients with cardiac catheterization before and immediately following percutaneous MV repair with the MitraClip device. In addition, pre- and post-procedural hemodynamic parameters were studied by transthoracic echocardiography. Results MitraClip treatment was attempted in 107 patients, and in 96 (90%) patients, a MitraClip was deployed. Successful MitraClip treatment resulted in: 1) an increase in CO from 5.0 ± 2.0 l/min to 5.7 ± 1.9 l/min (p = 0.003); 2) an increase in forward stroke volume (FSV) from 57 ± 17 ml to 65 ± 18 ml (p < 0.001); and 3) a decrease in systemic vascular resistance from 1,226 ± 481 dyn·s/cm5 to 1,004 ± 442 dyn·s/cm5 (p < 0.001). In addition, there was left ventricular (LV) unloading manifested by a decrease in LV end-diastolic pressure from 11.4 ± 9.0 mm Hg to 8.8 ± 5.8 mm Hg (p = 0.016) and a decrease in LV end-diastolic volume from 172 ± 37 ml to 158 ± 38 ml (p < 0.001). None of the patients developed acute post-procedural low CO state. Conclusions Successful MV repair with the MitraClip system results in an immediate and significant improvement in FSV, CO, and LV loading conditions. There was no evidence of a low CO state following MitraClip treatment for MR. These favorable hemodynamic effects with the MitraClip appear to reduce the risk of developing a low CO state, a complication occasionally observed after surgical MV repair for severe MR. (A Study of the Evalve Cardiovascular Valve Repair System Endovascular Valve Edge-to-Edge Repair Study EVEREST I; NCT00209339 and EVEREST II; NCT00209274 )
Objectives This study was designed for conducting a comparative evaluation of the healing response after Watchman (WM) (Boston Scientific, Plymouth, Minnesota) and Amplatzer Cardiac Plug (ACP) ...(St. Jude Medical, Minneapolis, Minnesota) in a canine left atrial appendage (LAA) model. Background There is no direct comparison of the WM and ACP device in pre-clinical or clinical settings. Methods The LAA from canine (n = 6) and human (n = 19) hearts were compared to determine the feasibility of the canine model and its relevance to clinical applications. Subsequently, implantation of WM and ACP in the canine LAA was performed (n = 3 per device) to evaluate the device conformation to the LA anatomy as well as the healing response at 28 days. Results The LAA is a variable tubular structure in both canine and human hearts. Gross examination showed that the WM was properly seated inside the LAA ostium, in comparison to the ACP where the disk was outside of the LAA orifice and extended to the edge of the left superior pulmonary vein and mitral valve. At 28 days, complete neo-endocardial coverage of the WM was observed; however, the ACP showed an incomplete covering on the disk surface especially at the lower edge and end-screw hub regions. Conclusions There are differences in conformation of LAA surrounding structures with variable healing response between WM and ACP after LAA closure in the canine model. WM does not obstruct or impact the LAA adjacent structures, resulting in a favorable surface recovery. In comparison, the disk of ACP could potentially jeopardize LAA neighboring structures and leads to delayed healing.
Objectives This study sought to assess quality of life parameters in a subset of patients enrolled in the PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for ...Prevention of Stroke in Patients With Atrial Fibrillation) trial. Background The PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial demonstrated that in patients with nonvalvular atrial fibrillation (AF) and CHADS2 (congestive heart failure, hypertension, age, diabetes mellitus, and prior stroke, transient ischemic attack, or thromboembolism) score ≥1, a left atrial appendage closure device is noninferior to long-term warfarin for stroke prevention. Given this equivalency, quality of life (QOL) indicators are an important metric for evaluating these 2 different strategies. Methods QOL using the Short-Form 12 Health Survey, version 2, measurement tool was obtained at baseline and 12 months in a subset of 547 patients in the PROTECT AF trial (361 device and 186 warfarin patients). The analysis cohort consisted of patients for whom either paired quality of life data were available after 12 months of follow-up or for patients who died. Results With the device, the total physical score improved in 34.9% and was unchanged in 29.9% versus warfarin in whom 24.7% were improved and 31.7% were unchanged (p = 0.01). Mental health improvement occurred in 33.0% of the device group versus 22.6% in the warfarin group (p = 0.06). There was a significant improvement in QOL in patients randomized to device for total physical score, physical function, and in physical role limitation compared to control. There were significant differences in the change in total physical score among warfarin naive and not–warfarin naive subgroups in the device group compared to control, but larger gains were seen with the warfarin naive subgroup with a 12-month change of 1.3 ± 8.8 versus −3.6 ± 6.7 (p = 0.0004) device compared to warfarin. Conclusions Patients with nonvalvular AF at risk for stroke treated with left atrial appendage closure have favorable QOL changes at 12 months versus patients treated with warfarin. (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation WATCHMAN PROTECT; NCT00129545 )
Transcatheter heart valve (THV) embolization is a rare but serious complication of transcatheter aortic valve implantation. Studies, including case reports, case series, and original reports ...published between 2002 and 2013, with regard to THV embolization were identified with a systemic electronic search using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. A total of 19 publications describing 71 patients were identified. Most patients (64%) were men, with a mean age of 80 ± 6 years and a mean logistic European System for Cardiac Operative Risk Evaluation score of 22.4 ± 9.3%. Balloon-expandable valves were used in 72% of the patients. The reported transcatheter aortic valve replacement access site was transfemoral in 80% of patients. Most cases (90%) occurred <1 hour after implantation, whereas 10% had late embolization (range 4 hours to 43 days). The most common site of embolization was the ascending aorta (38%), followed by the left ventricle (31%), descending aorta (23%), and aortic arch (8%). Open-heart surgery was required in 28% for valve retrieval and replacement. The 30-day stroke and mortality rates were 11% and 17%, respectively. Ventricular embolization and urgent conversion to open-heart surgery were significantly associated with death during hospitalization (p = 0.017 and p = 0.029, respectively). Likely causes of embolization were identified in 59 patients, with positioning error as the most commonly reported (47%), followed by pacing error (13%). In conclusion, THV embolization occurred early after transcatheter aortic valve implantation. The ascending aorta was the most common site of embolization. Higher 30-day stroke and mortality rates were associated with THV embolization compared with most published series of transcatheter aortic valve implantation outcomes.
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