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1.
2.

Objective

To assess risk factors for paravalvular leak (PVL) after transcatheter aortic valve implantation in a large single-center cohort, including measurement of aortic valve calcification using a reproducible method.

Methods

We retrospectively analyzed preoperative contrast-enhanced multidetector computed tomography scans of patients who underwent transcatheter aortic valve implantation in our center between 2009 and 2016. Calcium volume was calculated for each aortic cusp in the aortic valve, left ventricular outflow tract, and device landing zone.

Results

Overall, 539 patients were included in the study who had experience with 4 prothesis types (SapienXT [Edwards Lifesciences, Irvine, Calif] [n = 192], Sapien3 [Edwards Lifesciences] [n = 206], CoreValve EvolutR [Medtronic, Minneapolis, Minn] [n = 44], and Acurate [Symetis, Ecublens, Switzerland] [n = 97]). Median calcium volume in the device landing zone was 757 mm3, with no significant differences among the 4 prosthesis groups. None of the patients had severe PVL. The overall incidence of mild-to-moderate PVL was 15.8% (95% confidence interval [CI], 12.8%-19.1%). On multivariate logistic regression, device landing zone calcification (P = .00006; odds ratio for an increase of 100 mm3, 1.08; 95% CI, 1.04-1.13) and use of the CoreValve (P = .0028; odds ratio, 4.1; 95% CI, 1.6-10 with SapienXT as reference) prosthesis were found to be associated with mild or greater PVL. In contrast, degree of oversizing (P = .002; odds ratio, 0.97; 95% CI, 0.95-0.99), and use of Sapien3 (P = .00005; odds ratio, 0.23; 95% CI, 0.11-0.47 with SapienXT as reference) were associated with a lower incidence of mild or greater PVL.

Conclusions

Aortic calcification volume in the device landing zone is associated with residual PVL after transcatheter aortic valve implantation. When taking calcification into account, the balloon-expandable prosthesis Sapien3 seems to be associated with a lower incidence of PVL.  相似文献   

3.

Objectives

Coexisting aortic root and mitral valve pathology is increasingly recognized among patients undergoing surgery. We characterized the pathology and surgical outcomes of patients with combined aortic root and mitral disease.

Methods

From 1987 to 2016, 118 patients (age 52.40 ± 17.71 years) underwent concomitant aortic root and mitral procedures (excluding aortic stenosis, endocarditis, and reoperations). Aortic root pathologies included degenerative aneurysm (94%) and aortic dissection (6%). The aortic valve was bicuspid in 15% of patients and had normally functioning tricuspid leaflets in 23% of patients. Marfan syndrome was present in 34 patients (29%). Degenerative mitral disease predominated (78%). Mitral procedures were repair (86%) and replacement (14%), and root procedures were valve-preserving root reimplantation (36%), Bentall procedure (47%), and homograft root replacement (17%). In the last 10 years, the combination of valve-preserving root reimplantation and mitral repair has increased to 50%. Kaplan–Meier and competing risk analyses were used to estimate survival and reoperation.

Results

There were 2 (1.7%) operative deaths with survival of 79% and 71% at 10 and 15 years, respectively, and reoperation rates of 4.7% and 12% after 5 and 10 years, respectively. There were no operative deaths in patients with combined valve-preserving root reimplantation and mitral repair, with survival of 89% and reoperation rate of 7.8% at 10 years. Among patients with Bentall/homograft and mitral operation, survival was 73% and reoperation was 9.8% at 10 years.

Conclusions

In patients with aortic root and mitral pathology, combined surgical risk is low and valve durability is high. When possible, valve-preserving root reimplantation and mitral repair should be considered to avoid prosthesis degeneration, anticoagulation, and lifestyle limitations.  相似文献   

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Objectives

Sutureless aortic valve replacement (SU-AVR) is an alternative technique to standard aortic valve replacement. We evaluated our experience with the Perceval SU-AVR with concomitant mitral valve surgery, with or without tricuspid valve surgery, and aimed to discuss the technical considerations.

Methods

From January 2013 through June 2016, 30 patients with concomitant severe mitral valve disease, with or without tricuspid valve disease, underwent SU-AVR with the Perceval prosthesis in a single center.

Results

The mean age was 73.0 ± 6.6 years, ranging from 63 to 86 years, and 60% (n = 18) were male. Mean logistic EuroScore of the study cohort was 9.8 ± 4.6. Concomitant procedures consisted of mitral valve repair (n = 8, 26.6%), mitral valve replacement (n = 22, 73.3%), tricuspid valve repair (n = 18, 60%), tricuspid valve replacement (n = 2, 6.6%), and cryoablation for atrial fibrillation (n = 21, 70%). Median prosthesis size was 25 mm (large size). At 1 year, there were 2 deaths from noncardiac causes. One patient (3.3%) had third-degree atrioventricular block requiring permanent pacemaker implantation. Three patients (10%) had intraoperative supra-annular malpositioning of the aortic prosthesis, which was safely removed and reimplanted in all cases. Mean follow-up was 18 ± 4.5 for months (maximum 3 years). During the postoperative period, sinus rhythm restoration rate in patients who underwent the cryo-maze procedure was 76.1% (n = 16) at discharge. There was no structural valve deterioration or migration of the prosthesis at follow-up.

Conclusions

Perceval SU-AVR is a technically feasible and safe procedure in patients with severe aortic stenosis with good results even in the presence of multivalvular disease and atrial fibrillation surgery.  相似文献   

7.

Objective

The study objective was to assess the technical and process improvement and clinical outcomes of robotic mitral valve surgery by examining the first 1000 cases performed in a tertiary care center.

Methods

We reviewed the first 1000 patients (mean age, 56 ± 10 years) undergoing robotic primary mitral valve surgery, including concomitant procedures (n = 185), from January 2006 to November 2013. Mitral valve disease cause was degenerative (n = 960, 96%), endocarditis (n = 26, 2.6%), rheumatic (n = 10, 1.0%), ischemic (n = 3, 0.3%), and fibroelastoma (n = 1, 0.1%). All procedures were performed via right chest access with femoral perfusion for cardiopulmonary bypass.

Results

Mitral valve repair was attempted in 997 patients (2 planned replacements and 1 resection of fibroelastoma), 992 (99.5%) of whom underwent valve repair, and 5 (0.5%) of whom underwent valve replacement. Intraoperative postrepair echocardiography showed that 99.7% of patients receiving repair (989/992) left the operating room with no or mild mitral regurgitation, and predischarge echocardiography showed that mitral regurgitation remained mild or less in 97.9% of patients (915/935). There was 1 hospital death (0.1%), and 14 patients (1.4%) experienced a stroke; stroke risk declined from 2% in the first 500 patients to 0.8% in the second 500 patients. Over the course of the experience, myocardial ischemic and cardiopulmonary bypass times (P < .0001), transfusion (P = .003), and intensive care unit and postoperative lengths of stay (P < .05) decreased.

Conclusions

Robotic mitral valve surgery is associated with a high likelihood of valve repair and low operative mortality and morbidity. The combination of algorithm-driven patient selection and increased experience enhanced clinical outcomes and procedural efficiency.  相似文献   

8.

Objective

Stentless aortic valves have been developed to overcome obstructive limitations associated with stented bioprostheses. The aim of the current multi-institutional study was to compare hemodynamics of transcatheter (TAVR) and the Freedom SOLO Stentless (FS) valve in an intermediate risk population undergoing surgical aortic valve replacement.

Methods

From 2010 to 2014, 420 consecutive patients underwent isolated surgical aortic valve replacement with FS and 375 patients underwent TAVR. Only patients with intermediate operative risk (Society of Thoracic Surgeons score 4-10) and small aortic annulus (≤23 mm) were included. After a propensity matched analysis 142 patients in each group were selected. Thirty-day postoperative clinical and echocardiographic parameters were evaluated.

Results

Mean prosthesis diameter was 22.2 ± 0.9 mm for FS and 22.4 ± 1.0 mm for TAVR. In-hospital mortality was 2.1% for FS and 6.3% for TAVR (P = .02). Postoperative FS peak gradients were 19.1 ± 9.6 mm Hg (mean 10.8 ± 5.9 mm Hg); TAVR peak gradients were 20.2 ± 9.5 mm Hg (mean 10.7 ± 6.9 mm Hg) P = .57 (P = .88). Postoperative effective orifice area was 1.93 ± 0.52 cm2 for FS and 1.83 ± 0.3 cm2 for TAVR (P = .65). There was no prostheses-patient mismatch in either group. Postoperative grade 2-3 paravalvular leak was present in 3.5% for TAVR and 0.7% for FS. Postoperative permanent pacemaker implant rate was 12% for TAVR and only 1 case (0.7%) in the FS group (P < .001).

Conclusions

In patients with small aortic annulus and intermediate risk, both FS and TAVR demonstrated similar excellent hemodynamic performance. TAVR demonstrated greater mortality and rates of pacemaker insertion. Further studies are warranted to validate TAVR indications in this subset of patients.  相似文献   

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ObjectiveDeterioration of the native aortic valve function by a late progression of rheumatic disease is not infrequent in patients who underwent rheumatic mitral valve surgery; however, this phenomenon has not been clearly quantified.MethodsA total of 1155 consecutive patients (age 52.0 ± 12.9 years; 807 female) who underwent rheumatic mitral valve surgery without concomitant aortic valve surgery from 1997 to 2015 were enrolled. The primary end point was the composite of progression to severe aortic valve dysfunction or a requirement of subsequent aortic valve replacements during follow-up. To determine the risk factors of the primary outcome, we performed the generalized linear mixed model.ResultsThe baseline severities of aortic valve were none to trivial in 880 patients (76.2%), mild in 256 patients (22.2%), and moderate in 19 patients (1.6%). The latest 1062 echocardiographic assessments (91.9%; median, 81.2 postoperative months; interquartile range, 37.3-132.1 months) demonstrated 26 cases (0.33%/patient-year) meeting the primary end point during follow-up. Cumulative incidence of the primary end point at 10 years was 0.4% ± 0.3% and 7.4% ± 2.5% depending on the presence of mild or greater aortic valve dysfunction at baseline (P < .01). In multivariable analyses, aortic valve peak pressure gradient (odds ratio, 1.14; 95% confidence interval, 1.10-1.20), aortic regurgitation degree (mild over none: odds ratio, 3.26; 95% confidence interval, 1.15-9.23), and time (odds ratio, 1.30; 95% confidence interval 1.19-1.41) were significantly associated with the occurrence of the primary end point.ConclusionsProgression of severe aortic valve dysfunction and the need for aortic valve replacement are uncommon in patients undergoing rheumatic mitral valve surgery. However, such events were relatively common among those with mild or greater aortic valve dysfunction at the time of mitral valve surgery.  相似文献   

11.

Objectives

An increasing number of octogenarians are referred to undergo mitral valve surgery for degenerative disease, and percutaneous approaches are being increasingly used in this subgroup of patients. We sought to determine the survival and its predictors after Mitral Valve Surgery in Octogenarians (MiSO) in a multicenter UK study of high-volume specialized centers.

Methods

Pooled data from 3 centers were collected retrospectively. To identify the predictors of short-term composite outcome of 30 days mortality, acute kidney injury, and cerebrovascular accident, a multivariable logistic regression model was developed. Multiple Cox regression analysis was performed for late mortality. Kaplan–Meier curves were generated for long-term survival in various subsets of patients. Receiver operating characteristic analysis was done to determine the predictive power of the logistic European System for Cardiac Operative Risk Evaluation.

Results

A total of 247 patients were included in the study. The median follow-up was 2.9 years (minimum 0, maximum 14 years). A total of 150 patients (60.7%) underwent mitral valve repair, and 97 patients (39.3%) underwent mitral valve replacement. Apart from redo cardiac surgery (mitral valve repair 6 [4%] vs mitral valve replacement 11 [11.3%], P = .04) and preoperative atrial fibrillation (mitral valve repair 79 [52.6%] vs mitral valve replacement 34 [35.1%], P < .01), there was no significant difference in terms of any other preoperative characteristics between the 2 groups. Patient operative risk, as estimated by logistic European System for Cardiac Operative Risk Evaluation, was lower in the mitral valve repair group (10.2 ± 11.8 vs 13.7 ± 15.2 in mitral valve replacement; P = .07). No difference was found between groups for duration of cardiopulmonary bypass and aortic crossclamp times. The 30-day mortality for the whole cohort was 13.8% (mitral valve repair 4.7% vs mitral valve replacement 18.6%; P < .01). No differences were found in terms of postoperative cerebrovascular accident (2% vs 3.1%; P = .9), acute kidney injury requiring dialysis (6.7% vs 13.4%; P = .12), and superficial or deep sternal wound infection (10% vs 16.5%, P = .17; 2% vs 3.1%, P = .67, respectively). The final multiple regression model for short-term composite outcome included previous cardiac surgery (odds ratio [OR], 4.47; 95% confidence interval [CI], 1.37-17.46; P = .02), intra-aortic balloon pump use (OR, 4.77; 95% CI, 1.67-15.79; P < .01), and mitral valve replacement (OR, 7.7; 95% CI, 4.04-14.9; P < .01). Overall survival for the entire cohort at 1, 5, and 10 years was 82.4%, 63.7%, and 45.5% (mitral valve repair vs mitral valve replacement: 89.9% vs 70.7% at 1 year, 69.6% vs 54% at 5 years, and 51.8% vs 35.5% at 10 years; P = .0005). Cox proportional hazard model results showed mitral valve replacement (hazard ratio, 1.88; 95% CI, 1.22-2.89; P < .01) and intra-aortic balloon pump use (hazard ratio, 2.54; 95% CI, 1.26-5.13; P < .01) to be independent predictor factors affecting long-term survival. Logistic European System for Cardiac Operative Risk Evaluation did not perform well in predicting early mortality (area under the curve, 0.57%).

Conclusions

In octogenarians, mitral valve repair for degenerative disease is associated with good survival and remains the gold standard, whereas mitral valve replacement is still associated with significant mortality. Logistic European System for Cardiac Operative Risk Evaluation was unable to predict early mortality in our cohort of patients. Larger international multicenter registries are required to optimize the decision-making process in such a high-risk subgroup.  相似文献   

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13.

Objective

Newly published guidelines made the highest level recommendation for surgical treatment for atrial fibrillation. However, the number of patients without a mitral valve procedure with atrial fibrillation who are treated with concomitant surgical ablation is still low (15%-25%), because surgeons are reluctant to perform procedures in patients who would not otherwise require left atriotomy. The purpose of this study was to compare the outcomes of concomitant Cox maze with and without mitral valve procedures.

Methods

Patients who underwent concomitant Cox maze procedures were prospectively followed since September 2005. Of the 711 patients, 238 did not receive mitral valve surgery. Propensity score matching was conducted to balance preoperative characteristics between patients with and without mitral valve procedures (164/group after matching).

Results

Before matching, patients in the mitral valve group were younger (65 vs 67 years, P = .047) and had higher euroSCORE II (European System for Cardiac Operative Risk Evaluation; 3.2% vs 2.6%, P = .002), larger mean left atrial size (5.3 vs 4.8 cm, P < .001), and shorter median atrial fibrillation duration (19 vs 25 months, P = .064). Early outcomes were similar for the matched groups. Cumulative 5-year freedom from stroke did not differ between matched mitral valve and non–mitral valve groups (96.1% vs 96.6%, P = .667). At each time point, the proportion in sinus rhythm off antiarrhythmic medications was similar for the matched groups, including 5 years after surgery (68% vs 63%, P = .492).

Conclusions

The Cox maze procedure is safe and effective with comparable outcomes when performed concomitant to mitral valve or non–mitral valve surgery. Surgeons should base the decision to perform surgical ablation procedures on atrial fibrillation pathophysiology and the benefit to patients, not on the type of concomitant procedure.  相似文献   

14.

Objectives

We performed a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption to assess safety and efficacy of Perceval, a sutureless bovine pericardial aortic valve representing the initial US experience.

Methods

From June 2013 to January 2015, 300 patients (mean age 76.7 ± 7.7 years, 54.3% men, 37.3% ≥80 years, median Society of Thoracic Surgeons Predicted Risk of Mortality 2.8%), underwent Perceval valve implantation at 18 centers across the United States. Twenty patients (6.7%) had a bicuspid aortic valve and 5 (1.7%) patients had previous aortic valve replacement. A minimally invasive approach was used in 80 (26.7%) and concomitant procedures were performed in 113 (37.8%) patients.

Results

Two hundred eighty-nine patients (96.3%) were successfully implanted. Operative mortality (≤30 days) was 1.3% (n = 4) (observed to expected ratio of 0.40). One-year results included all-cause mortality in 5.2% (n = 15), stroke in 1% (n = 3), and endocarditis in 1.7% (n = 5). New permanent periprocedural pacemaker rate was 10.7% (n = 30/281); 2.5% (n = 7/281) resulted from third-degree atrioventricular block. One-year valve-related reoperation was 2.1% (n = 6). At 1-year follow-up, 98% of patients were in New York Heart Association class I/II, left ventricular mass index decreased from 103.5 ± 30.1 g/m2 at discharge to 95.8 ± 27.1 g/m2 (P = .001), and 3 (1.3%) moderate paravalvular leaks were identified. Health-related quality of life score increased from 62.7 ± 21.8 before surgery to 85.5 ± 17.8 at 1 year (P < .001).

Conclusions

These results confirm the safety and effectiveness of the Perceval sutureless aortic valve replacement in study patients with lower mortality than expected from a risk prediction model. Persistent hemodynamic benefit and improvement in quality of life at 1 year support the importance of this device in the management of aortic valve disease.  相似文献   

15.

Background

The TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) trial (NCT01700439) evaluated the performance of the INTUITY rapid deployment aortic valve replacement (RDAVR) system in patients with severe aortic stenosis.

Methods

TRANSFORM was a prospective, nonrandomized, multicenter (n = 29), single-arm trial. INTUITY is comprised of a cloth-covered balloon-expandable frame attached to a Carpentier-Edwards PERIMOUNT Magna Ease aortic valve. Primary and effectiveness endpoints were evaluated at 1 year.

Results

Between 2012 and 2015, 839 patients underwent RDAVR. Mean age was 73.5 ± 8.3 years. Full sternotomy (FS) was used in 59% and minimally invasive surgical incisions in 41%. Technical success rate was 95%. For isolated RDAVR, mean crossclamp and cardiopulmonary bypass times for FS were 49.3 ± 26.9 minutes and 69.2 ± 34.7 minutes, respectively, and for minimally invasive surgical 63.1 ± 25.4 minutes and 84.6 ± 33.5 minutes, respectively. These times were favorable compared with Society of Thoracic Surgeons database comparators for FS: 76.3 minutes and 104.2 minutes, respectively, and for minimally invasive surgical, 82.9 minutes and 111.4 minutes, respectively (P < .001). At 30 days, all-cause mortality was 0.8%; valve explant, 0.1%; thromboembolism, 3.5%; and major bleeding, 1.3%. In patients with isolated aortic valve replacement, the rate of permanent pacemaker implantation was 11.9%. At 1 year, mean effective orifice area was 1.7 cm2; mean gradient, 10.3 mm Hg; and moderate and severe paravalvular leak, 1.2% and 0.4%, respectively.

Conclusions

INTUITY RDAVR performed effectively in this North American trial. It may lead to a relative reduction in aortic crossclamp time and cardiopulmonary bypass time and has excellent hemodynamic performance. Pacemaker implantation rate observed was somewhat greater than European trials and requires further investigation.  相似文献   

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