Summary Background Transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve demonstrates good 30 day clinical outcomes in patients with severe aortic stenosis who are at intermediate ...risk of surgical mortality. Here we report longer-term data in intermediate-risk patients given SAPIEN 3 TAVR and compare outcomes to those of intermediate-risk patients given surgical aortic valve replacement. Methods In the SAPIEN 3 observational study, 1077 intermediate-risk patients at 51 sites in the USA and Canada were assigned to receive TAVR with the SAPIEN 3 valve 952 88% via transfemoral access) between Feb 17, 2014, and Sept 3, 2014. In this population we assessed all-cause mortality and incidence of strokes, re-intervention, and aortic valve regurgitation at 1 year after implantation. Then we compared 1 year outcomes in this population with those for intermediate-risk patients treated with surgical valve replacement in the PARTNER 2A trial between Dec 23, 2011, and Nov 6, 2013, using a prespecified propensity score analysis to account for between-trial differences in baseline characteristics. The clinical events committee and echocardiographic core laboratory methods were the same for both studies. The primary endpoint was the composite of death from any cause, all strokes, and incidence of moderate or severe aortic regurgitation. We did non-inferiority (margin 7·5%) and superiority analyses in propensity score quintiles to calculate pooled weighted proportion differences for outcomes. Findings At 1 year follow-up of the SAPIEN 3 observational study, 79 of 1077 patients who initiated the TAVR procedure had died (all-cause mortality 7·4%; 6·5% in the transfemoral access subgroup), and disabling strokes had occurred in 24 (2%), aortic valve re-intervention in six (1%), and moderate or severe paravalvular regurgitation in 13 (2%). In the propensity-score analysis we included 963 patients treated with SAPIEN 3 TAVR and 747 with surgical valve replacement. For the primary composite endpoint of mortality, strokes, and moderate or severe aortic regurgitation, TAVR was both non-inferior (pooled weighted proportion difference of −9·2%; 90% CI −12·4 to −6; p<0·0001) and superior (−9·2%, 95% CI −13·0 to −5·4; p<0·0001) to surgical valve replacement. Interpretation TAVR with SAPIEN 3 in intermediate-risk patients with severe aortic stenosis is associated with low mortality, strokes, and regurgitation at 1 year. The propensity score analysis indicates a significant superiority for our composite outcome with TAVR compared with surgery, suggesting that TAVR might be the preferred treatment alternative in intermediate-risk patients. Funding None.
Executive Summary Surgical ablation for atrial fibrillation (AF) can be performed without additional risk of operative mortality or major morbidity, and is recommended at the time of concomitant ...mitral operations to restore sinus rhythm. (Class I, Level A) Surgical ablation for AF can be performed without additional operative risk of mortality or major morbidity, and is recommended at the time of concomitant isolated aortic valve replacement, isolated coronary artery bypass graft surgery, and aortic valve replacement plus coronary artery bypass graft operations to restore sinus rhythm. (Class I, Level B nonrandomized) Surgical ablation for symptomatic AF in the absence of structural heart disease that is refractory to class I/III antiarrhythmic drugs or catheter-based therapy or both is reasonable as a primary stand-alone procedure, to restore sinus rhythm. (Class IIA, Level B randomized) Surgical ablation for symptomatic persistent or longstanding persistent AF in the absence of structural heart disease is reasonable, as a stand-alone procedure using the Cox-Maze III/IV lesion set compared with pulmonary vein isolation alone. (Class IIA, Level B nonrandomized) Surgical ablation for symptomatic AF in the setting of left atrial enlargement (≥4.5 cm) or more than moderate mitral regurgitation by pulmonary vein isolation alone is not recommended. (Class III no benefit, Level C expert opinion) It is reasonable to perform left atrial appendage excision or exclusion in conjunction with surgical ablation for AF for longitudinal thromboembolic morbidity prevention. (Class IIA, Level C limited data) At the time of concomitant cardiac operations in patients with AF, it is reasonable to surgically manage the left atrial appendage for longitudinal thromboembolic morbidity prevention. (Class IIA, Level C expert opinion) In the treatment of AF, multidisciplinary heart team assessment, treatment planning, and long-term follow-up can be useful and beneficial to optimize patient outcomes. (Class I, Level C expert opinion)
Internal thoracic arteries (ITAs) should be used to bypass the left anterior descending (LAD) artery when bypass of the LAD is indicated (class of recommendation COR I, level of evidence LOE B). As ...an adjunct to left internal thoracic artery (LITA), a second arterial graft (right ITA or radial artery RA) should be considered in appropriate patients (COR IIa, LOE B). Use of bilateral ITAs (BITAs) should be considered in patients who do not have an excessive risk of sternal complications (COR IIa, LOE B). To reduce the risk of sternal infection with BITA, skeletonized grafts should be considered (COR IIa, LOE B), smoking cessation is recommended (COR I, LOE C), glycemic control should be considered (COR IIa, LOE B), and enhanced sternal stabilization may be considered (COR IIb, LOE C). As an adjunct to LITA to LAD (or in patients with inadequate LITA grafts), use of a RA graft is reasonable when grafting coronary targets with severe stenoses (COR IIa, LOE: B). When RA grafts are used, it is reasonable to use pharmacologic agents to reduce acute intraoperative and perioperative spasm (COR IIa, LOE C). The right gastroepiploic artery may be considered in patients with poor conduit options or as an adjunct to more complete arterial revascularization (COR IIb, LOE B). Use of arterial grafts (specific targets, number, and type) should be a part of the discussion of the heart team in determining the optimal approach for each patient (COR I, LOE C).
Prosthesis-patient mismatch (PPM) occurs when the effective orifice area (EOA) of the prosthetic valve is too small in relation to a patient’s body size, thus resulting in high residual postoperative ...pressure gradients across the prosthesis. Severe PPM occurs in 2% to 20% of patients undergoing surgical aortic valve replacement (AVR) and is associated with 1.5- to 2.0-fold increase in the risk of mortality and heart failure rehospitalization. The purpose of this article is to present an overview of the role of multimodality imaging in the assessment, prediction, prevention, and management of PPM following AVR. The risk of PPM can be anticipated at the time of AVR by calculating the predicted indexed from the normal reference value of EOA of the selected prosthesis and patient’s body surface area. The strategies to prevent PPM at the time of surgical AVR include: 1) implanting a newer generation of prosthetic valve with better hemodynamic; 2) enlarging the aortic root or annulus to accommodate a larger prosthetic valve; or 3) performing TAVR rather than surgical AVR. The identification and quantitation of PPM as well as its distinction versus prosthetic valve stenosis is primarily based on transthoracic echocardiography, but important information may be obtained from other imaging modalities such as transesophageal echocardiography and multidetector computed tomography. PPM is characterized by high transprosthetic velocity and gradients, normal EOA, small indexed EOA, and normal leaflet morphology and mobility. Transesophageal echocardiography and multidetector computed tomography are particularly helpful to assess prosthetic valve leaflet morphology and mobility, which is a cornerstone of the differential diagnosis between PPM and pathologic valve obstruction. Severe symptomatic PPM following AVR with a bioprosthetic valve may be treated by redo surgery or the transcatheter valve-in-valve procedure with fracturing of the surgical valve stent.
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The STS-ACC TVT Registry (Society of Thoracic Surgeons–American College of Cardiology Transcatheter Valve Therapy Registry) from 2011 to 2019 has collected data on 276,316 patients undergoing ...transcatheter aortic valve replacement (TAVR) at sites in all U.S. states. Volumes have increased every year, exceeding surgical aortic valve replacement in 2019 (72,991 vs. 57,626), and it is now performed in all U.S. states. TAVR now extends from extreme- to low-risk patients. This is the first presentation on 8,395 low-risk patients treated in 2019. In 2019, for the entire cohort, femoral access increased to 95.3%, hospital stay was 2 days, and 90.3% were discharged home. Since 2011, the 30-day mortality rate has decreased (7.2% to 2.5%), stroke has started to decrease (2.75% to 2.3%), but pacemaker need is unchanged (10.9% to 10.8%). Alive with acceptable patient-reported outcomes is achieved in 8 of 10 patients at 1 year. The Registry is a national resource to improve care and analyze TAVR’s evolution. Real-world outcomes, site performance, and the impact of coronavirus disease 2019 will be subsequently studied. (STS/ACC Transcatheter Valve Therapy Registry TVT Registry; NCT01737528)
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•The STS-ACC TVT Registry documents the growth of TAVR in the United States.•Low-risk patients and valve-in-valve procedures are rapidly growing subsets of TAVR procedures.•The Registry will continue to gather data on the demographics and outcomes of TAVR procedures and allow assessment of the impact of the COVID-19 on patients and health systems involved in this procedure.
Data from The Society of Thoracic Surgeons Adult Cardiac Surgery Database were analyzed to identify trends in patient characteristics and outcomes of mitral valve operations in North America.
All ...patients with isolated primary mitral valve operations with or without tricuspid valve repair, surgical atrial fibrillation ablation, or atrial septal defect closure performed July 2011 to September 2016 were identified. A subgroup analysis assessed patients with degenerative leaflet prolapse (DLP).
Isolated primary mitral valve operations were performed on 87,214 patients at 1,125 centers, increasing by 24% between 2011 (n = 14,442) and 2016 (n = 17,907). The most common etiology was DLP (60.7%); 4.3% had functional mitral regurgitation. Preoperatively, 47.3% of patients had an ejection fraction less than 60% and 34.2% had atrial fibrillation. Overall mitral valve repair rate was 65.6%, declining from 67.1% (2011) to 63.2% (2016; p < 0.0001). Repair rates were related to etiology (DLP, 82.5%; rheumatic, 17.5%). Of the 29,970 mitral valve replacements, 16.2% were preceded by an attempted repair. Repair techniques included prosthetic annuloplasty (94.3%), leaflet resection (46.5%), and artificial cord implantation (22.7%). Bioprosthetic valves were implanted with increasing frequency (2011, 65.4%; 2016, 75.8%; p < 0.0001). Less-invasive operations were performed in 23.0% and concomitant tricuspid valve repair in 15.7%. Unadjusted operative mortality was 3.7% (replacements) and 1.1% (repairs).
Patients undergoing primary isolated mitral valve operations commonly have ventricular dysfunction, atrial fibrillation, and heart failure. Although contemporary outcomes are excellent, earlier guideline-directed referral and increased frequency and quality of repair may further improve results of mitral valve operations.
The Society of Thoracic Surgeons (STS) uses statistical models to create risk-adjusted performance metrics for Adult Cardiac Surgery Database (ACSD) participants. Because of temporal changes in ...patient characteristics and outcomes, evolution of surgical practice, and additional risk factors available in recent ACSD versions, completely new risk models have been developed.
Using July 2011 to June 2014 ACSD data, risk models were developed for operative mortality, stroke, renal failure, prolonged ventilation, mediastinitis/deep sternal wound infection, reoperation, major morbidity or mortality composite, prolonged postoperative length of stay, and short postoperative length of stay among patients who underwent isolated coronary artery bypass grafting surgery (n = 439,092), aortic or mitral valve surgery (n = 150,150), or combined valve plus coronary artery bypass grafting surgery (n = 81,588). Separate models were developed for each procedure and endpoint except mediastinitis/deep sternal wound infection, which was analyzed in a combined model because of its infrequency. A surgeon panel selected predictors by assessing model performance and clinical face validity of full and progressively more parsimonious models. The ACSD data (July 2014 to December 2016) were used to assess model calibration and to compare discrimination with previous STS risk models.
Calibration in the validation sample was excellent for all models except mediastinitis/deep sternal wound infection, which slightly underestimated risk and will be recalibrated in feedback reports. The c-indices of new models exceeded those of the last published STS models for all populations and endpoints except stroke in valve patients.
New STS ACSD risk models have generally excellent calibration and discrimination and are well suited for risk adjustment of STS performance metrics.
Background The introduction of transcatheter aortic valve replacement mandates attention to outcomes after surgical aortic valve replacement (SAVR) in low-risk, intermediate-risk, and very high-risk ...patients. Methods The study population included 141,905 patients who underwent isolated primary SAVR from 2002 to 2010. Patients were risk-stratified by Society of Thoracic Surgeons (STS) predicted risk of mortality (PROM) <4% (group 1, n = 113,377), 4% to 8% (group 2, n = 19,769), and >8% (group 3, n = 8,759). The majority of patients were considered at low risk (80%), and only 6.2% were categorized as being at high risk. Outcomes were analyzed based on two time periods: 2002 to 2006 (n = 63,754) and 2007 to 2010 (n = 78,151). Results The mean age was 65 years in group 1, 77 in group 2, and 77 in group 3 ( p < 0.0001). The median STS PROM for the entire population was 1.84: 1.46% in group 1, 5.24% in group 2, and 11.2% in group 3 ( p < 0.0001). Compared with PROM, in-hospital mean mortality was lower than expected in all patients (2.5% vs 2.95%) and when analyzed within risk groups was as follows: group 1 (1.4% vs 1.7%), group 2 (5.1% vs 5.5%), and group 3 (11.8% vs 13.7%) ( p < 0.0001). In the most recent surgical era, operative mortality was significantly reduced in group 2 (5.4% vs 6.4%, p = 0.002) and group 3 (11.9% vs 14.4%, p = 0.0004) but not in group 1. Conclusions Nearly 80% of patients undergoing SAVR have outcomes that are superior to those by the predicted risk models. In the most recent era, early results have further improved in medium-risk and high-risk patients. This large real-world assessment serves as a benchmark for patients with aortic valve stenosis as therapeutic options are further evaluated.
IMPORTANCE: Transcatheter aortic valve replacement (TAVR) indications are expanding, leading to an increasing number of patients with bicuspid aortic stenosis undergoing TAVR. Pivotal randomized ...trials conducted to obtain US Food and Drug Administration approval excluded bicuspid anatomy. OBJECTIVE: To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis. DESIGN, SETTING, AND PARTICIPANTS: Registry-based prospective cohort study of patients undergoing TAVR at 552 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapies Registry from June 2015 to November 2018. EXPOSURES: TAVR for bicuspid vs tricuspid aortic stenosis. MAIN OUTCOMES AND MEASURES: Primary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications, valve hemodynamics, and quality of life assessment. RESULTS: Of 81 822 consecutive patients with aortic stenosis (2726 bicuspid; 79 096 tricuspid), 2691 propensity-score matched pairs of bicuspid and tricuspid aortic stenosis were analyzed (median age, 74 years interquartile range {IQR}, 66-81 years; 39.1%, women; mean SD STS-predicted risk of mortality, 4.9% 4.0% and 5.1% 4.2%, respectively). All-cause mortality was not significantly different between patients with bicuspid and tricuspid aortic stenosis at 30 days (2.6% vs 2.5%; hazard ratio HR, 1.04, 95% CI, 0.74-1.47) and 1 year (10.5% vs 12.0%; HR, 0.90 95% CI, 0.73-1.10). The 30-day stroke rate was significantly higher for bicuspid vs tricuspid aortic stenosis (2.5% vs 1.6%; HR, 1.57 95% CI, 1.06-2.33). The risk of procedural complications requiring open heart surgery was significantly higher in the bicuspid vs tricuspid cohort (0.9% vs 0.4%, respectively; absolute risk difference RD, 0.5% 95% CI, 0%-0.9%). There were no significant differences in valve hemodynamics. There were no significant differences in moderate or severe paravalvular leak at 30 days (2.0% vs 2.4%; absolute RD, 0.3% 95% CI, −1.3% to 0.7%) and 1 year (3.2% vs 2.5%; absolute RD, 0.7% 95% CI, −1.3% to 2.7%). At 1 year there was no significant difference in improvement in quality of life between the groups (difference in improvement in the Kansas City Cardiomyopathy Questionnaire overall summary score, −2.4 95% CI, −5.1 to 0.3; P = .08). CONCLUSIONS AND RELEVANCE: In this preliminary, registry-based study of propensity-matched patients who had undergone transcatheter aortic valve replacement for aortic stenosis, patients with bicuspid vs tricuspid aortic stenosis had no significant difference in 30-day or 1-year mortality but had increased 30-day risk for stroke. Because of the potential for selection bias and the absence of a control group treated surgically for bicuspid stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis.
A previous analysis in this trial showed that among patients with severe, symptomatic aortic stenosis who were at low surgical risk, the rate of the composite end point of death, stroke, or ...rehospitalization at 1 year was significantly lower with transcatheter aortic-valve replacement (TAVR) than with surgical aortic-valve replacement. Longer-term outcomes are unknown.
We randomly assigned patients with severe, symptomatic aortic stenosis and low surgical risk to undergo either TAVR or surgery. The first primary end point was a composite of death, stroke, or rehospitalization related to the valve, the procedure, or heart failure. The second primary end point was a hierarchical composite that included death, disabling stroke, nondisabling stroke, and the number of rehospitalization days, analyzed with the use of a win ratio analysis. Clinical, echocardiographic, and health-status outcomes were assessed through 5 years.
A total of 1000 patients underwent randomization: 503 patients were assigned to undergo TAVR, and 497 to undergo surgery. A component of the first primary end point occurred in 111 of 496 patients in the TAVR group and in 117 of 454 patients in the surgery group (Kaplan-Meier estimates, 22.8% in the TAVR group and 27.2% in the surgery group; difference, -4.3 percentage points; 95% confidence interval CI, -9.9 to 1.3; P = 0.07). The win ratio for the second primary end point was 1.17 (95% CI, 0.90 to 1.51; P = 0.25). The Kaplan-Meier estimates for the components of the first primary end point were as follows: death, 10.0% in the TAVR group and 8.2% in the surgery group; stroke, 5.8% and 6.4%, respectively; and rehospitalization, 13.7% and 17.4%. The hemodynamic performance of the valve, assessed according to the mean (±SD) valve gradient, was 12.8±6.5 mm Hg in the TAVR group and 11.7±5.6 mm Hg in the surgery group. Bioprosthetic-valve failure occurred in 3.3% of the patients in the TAVR group and in 3.8% of those in the surgery group.
Among low-risk patients with severe, symptomatic aortic stenosis who underwent TAVR or surgery, there was no significant between-group difference in the two primary composite outcomes. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.).
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