Publications by authors named "Vinod H Thourani"

473 Publications

A Composite Metric for Benchmarking Site Performance in TAVR: Results from the STS/ACC TVT Registry.

Circulation 2021 May 5. Epub 2021 May 5.

Division of Cardiovascular Surgery, Hospital of the University of Pennsylvania, Philadelphia, PA; Penn Cardiovascular Outcomes, Quality, and Evaluative Research Center, Leonard Davis Institute of Health Economics, Philadelphia, PA.

Transcatheter aortic valve replacement (TAVR) is a transformative therapy for aortic stenosis. Despite rapid improvements in technology and techniques, serious complications remain relatively common and are not well described by single outcome measures. The purpose of this study was to determine if there is site-level variation in TAVR outcomes in the United States using a novel 30-day composite measure. We performed a retrospective cohort study using data from the STS/ACC TVT Registry to develop a novel ranked composite performance measure that incorporates mortality and serious complications. The selection and rank order of the complications for the composite was determined by their adjusted association with 1-year outcomes. Sites whose risk-adjusted outcomes were significantly more or less frequent than the national average based on a 95% probability interval were classified as performing worse or better than expected. The development cohort consisted of 52,561 patients who underwent TAVR between January 1, 2015 and December 31, 2017. Based on the associations with 1-year risk-adjusted mortality and health status, we identified four periprocedural complications to include in the composite risk model in addition to mortality. Ranked empirically according to severity, these included stroke, major, life-threatening or disabling bleeding, stage III acute kidney injury, and moderate or severe peri-valvular regurgitation. Based on these ranked outcomes, we found that there was significant site-level variation in quality of care in TAVR in the United States. Overall, better than expected site performance was observed in 25/301 (8%) of sites; performance as expected was observed in 242/301 sites (80%); and worse than expected performance was observed in 34/301 (11%) of sites. Thirty-day mortality, stroke, major, life-threatening or disabling bleeding, and moderate or severe peri-valvular leak were each substantially more common in sites with worse than expected performance as compared with other sites. There was good aggregate reliability of the model. There are substantial variations in the quality of TAVR care received in the United States, and 11% of sites were identified as providing care below the average level of performance. Further study is necessary to determine structural, process-related, and technical factors associated with high- and low-performing sites.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.051456DOI Listing
May 2021

Long-term outcomes of aortic root operations in the United States among Medicare beneficiaries.

J Thorac Cardiovasc Surg 2021 Feb 25. Epub 2021 Feb 25.

Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University Medical Center, Durham, NC. Electronic address:

Objective: The best method of aortic root repair in older patients remains unknown given a lack of comparative effectiveness of long-term outcomes data. The objective of this study was to compare long-term outcomes of different surgical approaches for aortic root repair in Medicare patients using The Society of Thoracic Surgeons Adult Cardiac Surgery Database-Centers for Medicare & Medicaid Services-linked data.

Methods: A retrospective cohort study was performed by querying the Society of Thoracic Surgeons Adult Cardiac Surgery Database for patients aged 65 years or more who underwent elective aortic root repair with or without aortic valve replacement. Primary long-term end points were mortality, any stroke, and aortic valve reintervention. Short-term outcomes and long-term survival were compared among each root repair strategy. Additional risk factors for mortality after aortic root repair were assessed with a multivariable Cox proportional hazards model.

Results: A total of 4173 patients aged 65 years or more underwent elective aortic root repair. Patients were stratified by operative strategy: mechanical Bentall, stented bioprosthetic Bentall, stentless bioprosthetic Bentall, or valve-sparing root replacement. Mean follow-up was 5.0 (±4.6) years. Relative to mechanical Bentall, stented bioprosthetic Bentall (adjusted hazard ratio, 0.80; confidence interval, 0.66-0.97) and stentless bioprosthetic Bentall (adjusted hazard ratio, 0.70; confidence interval, 0.59-0.84) were associated with better long-term survival. In addition, stentless bioprosthetic Bentall (adjusted hazard ratio, 0.64; confidence interval, 0.47-0.80) and valve-sparing root replacement (adjusted hazard ratio, 0.51; confidence interval, 0.29-0.90) were associated with lower long-term risk of stroke. Aortic valve reintervention risk was 2-fold higher after valve-sparing root replacement compared with other operative strategies.

Conclusions: In the Medicare population, there was poorer late survival and greater late stroke risk for patients undergoing mechanical Bentall and a higher rate of reintervention for valve-sparing root replacement. Bioprosthetic Bentall may be the procedure of choice in older patients undergoing aortic root repair, particularly in the era of transcatheter aortic valve replacement.
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http://dx.doi.org/10.1016/j.jtcvs.2021.02.068DOI Listing
February 2021

STS Adult Cardiac Surgery Database: 2021 Update on Outcomes, Quality, and Research.

Ann Thorac Surg 2021 Mar 29. Epub 2021 Mar 29.

Department of Cardiovascular and Thoracic Surgery, West Virginia University, Morgantown, West Virginia.

The Society of Thoracic Surgeons Adult Cardiac Surgery Database is the most mature and comprehensive cardiac surgery database. It has been the foundation for quality measurement and improvement activities in cardiac surgery, facilitated the generation of accurate risk adjusted performance benchmarks and serves as a platform for novel research. Recent enhancements have added to the database's functionality, ease of use, and value to multiple stakeholders. This report is the sixth in a series of annual reports that provide updated volumes, outcomes, database-related developments, quality improvement initiatives, and research summaries using the Adult Cardiac Surgery Database in the past year.
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http://dx.doi.org/10.1016/j.athoracsur.2021.03.043DOI Listing
March 2021

Commentary: American Heart Association/American College of Cardiology Valve guidelines: Starting point for discussion by the heart team or dictum?

J Thorac Cardiovasc Surg 2021 Feb 27. Epub 2021 Feb 27.

Department of Cardiovascular Surgery, Marcus Valve Center, Piedmont Heart Institute, Atlanta, Ga. Electronic address:

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http://dx.doi.org/10.1016/j.jtcvs.2021.02.080DOI Listing
February 2021

Atrial Fibrillation Is Associated With Mortality in Intermediate Surgical Risk Patients With Severe Aortic Stenosis: Analyses From the PARTNER 2A and PARTNER S3i Trials.

J Am Heart Assoc 2021 Apr 23;10(7):e019584. Epub 2021 Mar 23.

Division of Cardiology NewYork Presbyterian-Columbia University Medical Center New York NY.

Background The impact of atrial fibrillation (AF) in intermediate surgical risk patients with severe aortic stenosis who undergo either transcatheter or surgical aortic valve replacement (AVR) is not well established. Methods and Results Data were assessed in 2663 patients from the PARTNER (Placement of Aortic Transcatheter Valve) 2A or S3i trials. Analyses grouped patients into 3 categories according to their baseline and discharge rhythms (ie, sinus rhythm [SR]/SR, SR/AF, or AF/AF). Among patients with transcatheter AVR (n=1867), 79.2% had SR/SR, 17.6% had AF/AF, and 3.2% had SR/AF. Among patients with surgical AVR (n=796), 71.7% had SR/SR, 14.1% had AF/AF, and 14.2% had SR/AF. Patients with transcatheter AVR in AF at discharge had increased 2-year mortality (SR/AF versus SR/SR; hazard ratio [HR], 2.73; 95% CI, 1.68-4.44; <0.0001; AF/AF versus SR/SR; HR, 1.56; 95% CI, 1.16-2.09; =0.003); patients with SR/AF also experienced increased 2-year mortality relative to patients with AF/AF (HR, 1.77; 95% CI, 1.04-3.00; =0.03). For patients with surgicalAVR, the presence of AF at discharge was also associated with increased 2-year mortality (SR/AF versus SR/SR; HR, 1.93; 95% CI, 1.25-2.96; =0.002; and AF/AF versus SR/SR; HR, 1.67; 95% CI, 1.06-2.63; =0.027). Rehospitalization and persistent advanced heart failure symptoms were also more common among patients with transcatheter AVR and surgical AVR discharged in AF, and major bleeding was more common in the transcatheter AVR cohort. Conclusions The presence of AF at discharge in patients with intermediate surgical risk aortic stenosis was associated with worse outcomes-especially in patients with baseline SR-including increased all-cause mortality at 2-year follow-up. Registration URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01314313 and NCT03222128.
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http://dx.doi.org/10.1161/JAHA.120.019584DOI Listing
April 2021

Commentary: Younger patients are choosing tissue valves: Do the data match their fervor?

J Thorac Cardiovasc Surg 2021 Feb 24. Epub 2021 Feb 24.

Department of Cardiovascular Surgery, Marcus Valve Center, Piedmont Heart Institute, Atlanta, Ga. Electronic address:

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http://dx.doi.org/10.1016/j.jtcvs.2021.02.061DOI Listing
February 2021

Predicting the EQ-5D from the Kansas City Cardiomyopathy Questionnaire (KCCQ) in Patients with Heart Failure.

Eur Heart J Qual Care Clin Outcomes 2021 Mar 16. Epub 2021 Mar 16.

Saint Luke's Mid America Heart Institute, Kansas City, MO, USA.

Introduction: Evaluation of health status benefits, cost-effectiveness, and value of new heart failure therapies is critical for supporting their use. The Kansas City Cardiomyopathy Questionnaire (KCCQ) measures patients' heart failure-specific health status, but does not provide utilities needed for cost-effectiveness analyses. We mapped the KCCQ scores to EQ-5D scores so that estimates of societal-based utilities can be generated to support economic analyses.

Methods: Using data from two U.S. cohort studies, we developed models for predicting EQ-5D utilities (3L and 5L versions) from the KCCQ (23- and 12-item versions). In addition to predicting scores directly, we considered predicting the five EQ-5D health state items and deriving utilities from the predicted responses, allowing different countries' health state valuations to be used. Model validation was performed internally via bootstrap and externally using data from two clinical trials. Model performance was assessed using R2, mean prediction error, mean absolute prediction error, and calibration of observed versus predicted values.

Results: The EQ-5D-3L models were developed from 1,000 health status assessments in 547 patients with heart failure and reduced ejection fraction (HFrEF), while the EQ-5D-5L model was developed from 3,925 patients with HFrEF. For both versions, models predicting individual EQ-5D items performed as well as those predicting utilities directly. The selected models for the 3L had internally validated R-squares of 48.4-50.5% and 33.7-45.6% on external validation. The 5L version had validated R-square of 57.7%.

Conclusion: Mappings from the KCCQ to the EQ-5D can yield estimates of societal-based utilities to support cost-effectiveness analyses when EQ-5D data are not available.
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http://dx.doi.org/10.1093/ehjqcco/qcab014DOI Listing
March 2021

Sex disparities in patients with symptomatic severe aortic stenosis.

Am Heart J 2021 Mar 17;237:116-126. Epub 2021 Mar 17.

Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC. Electronic address:

Background: We evaluated whether there is equitable distribution across sexes of treatment and outcomes for aortic valve replacement (AVR), via surgical (SAVR) or transcatheter (TAVR) methods, in symptomatic severe aortic stenosis (ssAS) patients.

Methods: Using de-identified data, we identified 43,822 patients with ssAS (2008-2016). Multivariate competing risk models were used to determine the likelihood of any AVR, while accounting for the competing risk of death. Association between sex and 1-year mortality, stratified by AVR status, was evaluated using multivariate Cox regression models with AVR as a time-dependent variable.

Results: Among patients with ssAS, 20,986 (47.9%) were female. Females were older (median age 81 vs. 78, P<0.001), more likely to have body mass index <20 (8.5% vs. 3.5%), and home oxygen use (4.4% vs. 3.4%, P<0001 for all). Overall, 12,129 (27.7%) patients underwent AVR for ssAS. Females were less likely to undergo AVR compared with males (24.1% vs. 31.0%, adjusted hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.77-0.83), but when treated, were more likely to undergo TAVR (37.9% vs. 30.9%, adjusted HR 1.21, 95% CI 1.15-1.27). Untreated females and males had similarly high rates of mortality at 1 year (31.1% vs. 31.3%, adjusted HR 0.98, 95% CI 0.94-1.03). Among those undergoing AVR, females had significantly higher mortality (10.2% vs. 9.4%, adjusted HR 1.24, 95% CI 1.10-1.41), driven by increased SAVR-associated mortality (9.0% vs. 7.6%, adjusted HR 1.43, 95% CI 1.21-1.69).

Conclusions: Treatment rates for ssAS patients remain suboptimal with disparities in female treatment.
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http://dx.doi.org/10.1016/j.ahj.2021.01.021DOI Listing
March 2021

Atrial Fibrillation and Outcomes After Transcatheter or Surgical Aortic Valve Replacement (from the PARTNER 3 Trial).

Am J Cardiol 2021 Jun 7;148:116-123. Epub 2021 Mar 7.

Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York. Electronic address:

The prognostic impact of preexisting atrial fibrillation or flutter (AF) in low-risk patients with severe aortic stenosis treated with transcatheter (TAVR) or surgical aortic valve replacement (SAVR) remains unknown. In this sub-analysis of the PARTNER 3 trial of patients with severe aortic stenosis at low surgical risk randomized 1:1 to TAVR versus SAVR, clinical outcomes were analyzed at 2 years according to AF status. Among 948 patients included in the analysis (452 [47.7%] in the SAVR vs 496 [52.3%] in the TAVR arm), 168 (17.6%) patients had AF [88/452 (19.5%) and 80/496 (16.1%) treated with SAVR and TAVR, respectively]. At 2 years, patients with AF had higher unadjusted rates of the composite outcome of death, stroke or rehospitalization (21.2% vs 12.9%, p = 0.007) and rehospitalization alone (15.3% vs 9.4%, p = 0.03) but not all cause death (3.8% vs 2.6%, p = 0.45) or stroke (4.8% vs 2.6%, p = 0.12). In adjusted analyses, patients with AF had a higher risk for the composite outcome of death, stroke or rehospitalization (hazard ratio [HR] 1.80, 95% confidence interval [CI] 1.20-2.71, p = 0.0046) and rehospitalization alone (HR 1.8, 95% CI 0.12-2.9, p = 0.015), but not death or stroke. There was no interaction between treatment modality and AF on the composite outcome (Pinter = 0.83). In conclusion, preexisting AF in patients with severe AS at low surgical risk was associated with increased risk of the composite outcome of death, stroke or rehospitalization at 2 years, irrespective of treatment modality.
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http://dx.doi.org/10.1016/j.amjcard.2021.02.040DOI Listing
June 2021

Transcatheter Aortic Valve Replacement in Bicuspid Aortic Valve Stenosis.

Circulation 2021 Mar 8;143(10):1043-1061. Epub 2021 Mar 8.

Centre Hospitalier Universitaire de Lille, Institut Cœur Poumon, Cardiology, Department of Interventional Cardiology for Coronary, Valves and Structural Heart Diseases (F.V., T.D., C.D., N.D., B.V., B.S., T.P., H.S., G.S., E.VB.).

After 15 years of successive randomized, controlled trials, indications for transcatheter aortic valve replacement (TAVR) are rapidly expanding. In the coming years, this procedure could become the first line treatment for patients with a symptomatic severe aortic stenosis and a tricuspid aortic valve anatomy. However, randomized, controlled trials have excluded bicuspid aortic valve (BAV), which is the most frequent congenital heart disease occurring in 1% to 2% of the total population and representing at least 25% of patients 80 years of age or older referred for aortic valve replacement. The use of a less invasive transcatheter therapy in this elderly population became rapidly attractive, and approximately 10% of patients currently undergoing TAVR have a BAV. The U.S. Food and Drug Administration and the "European Conformity" have approved TAVR for low-risk patients regardless of the aortic valve anatomy whereas international guidelines recommend surgical replacement in BAV populations. Given this progressive expansion of TAVR toward younger and lower-risk patients, heart teams are encountering BAV patients more frequently, while the ability of this therapy to treat such a challenging anatomy remains uncertain. This review will address the singularity of BAV anatomy and associated technical challenges for the TAVR procedure. We will examine and summarize available clinical evidence and highlight critical knowledge gaps regarding TAVR utilization in BAV patients. We will provide a comprehensive overview of the role of computed tomography scans in the diagnosis, and classification of BAV and TAVR procedure planning. Overall, we will offer an integrated framework for understanding the current role of TAVR in the treatment of bicuspid aortic stenosis and for guiding physicians in clinical decision-making.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.048048DOI Listing
March 2021

Outcomes 2 Years After Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk.

J Am Coll Cardiol 2021 Mar;77(9):1149-1161

Department of Medicine, Laval University, Quebec, Quebec, Canada.

Background: In low surgical risk patients with symptomatic severe aortic stenosis, the PARTNER 3 (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis) trial demonstrated superiority of transcatheter aortic valve replacement (TAVR) versus surgery for the primary endpoint of death, stroke, or re-hospitalization at 1 year.

Objectives: This study determined both clinical and echocardiographic outcomes between 1 and 2 years in the PARTNER 3 trial.

Methods: This study randomly assigned 1,000 patients (1:1) to transfemoral TAVR with the SAPIEN 3 valve versus surgery (mean Society of Thoracic Surgeons score: 1.9%; mean age: 73 years) with clinical and echocardiography follow-up at 30 days and at 1 and 2 years. This study assessed 2-year rates of the primary endpoint and several secondary endpoints (clinical, echocardiography, and quality-of-life measures) in this as-treated analysis.

Results: Primary endpoint follow-up at 2 years was available in 96.5% of patients. The 2-year primary endpoint was significantly reduced after TAVR versus surgery (11.5% vs. 17.4%; hazard ratio: 0.63; 95% confidence interval: 0.45 to 0.88; p = 0.007). Differences in death and stroke favoring TAVR at 1 year were not statistically significant at 2 years (death: TAVR 2.4% vs. surgery 3.2%; p = 0.47; stroke: TAVR 2.4% vs. surgery 3.6%; p = 0.28). Valve thrombosis at 2 years was increased after TAVR (2.6%; 13 events) compared with surgery (0.7%; 3 events; p = 0.02). Disease-specific health status continued to be better after TAVR versus surgery through 2 years. Echocardiographic findings, including hemodynamic valve deterioration and bioprosthetic valve failure, were similar for TAVR and surgery at 2 years.

Conclusions: At 2 years, the primary endpoint remained significantly lower with TAVR versus surgery, but initial differences in death and stroke favoring TAVR were diminished and patients who underwent TAVR had increased valve thrombosis. (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis [PARTNER 3]; NCT02675114).
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http://dx.doi.org/10.1016/j.jacc.2020.12.052DOI Listing
March 2021

Predicting leaflet thrombosis: Is the clue in the blood?

Ann Thorac Surg 2021 Feb 10. Epub 2021 Feb 10.

Department of Biomedical Engineering, Georgia Institute of Technology, 387 Technology Circle NW, Atlanta, GA 30313. Electronic address:

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http://dx.doi.org/10.1016/j.athoracsur.2021.01.048DOI Listing
February 2021

Transcatheter devices for direct annuloplasty and chordal replacement in degenerative mitral regurgitation.

Ann Cardiothorac Surg 2021 Jan;10(1):164-166

Department of Cardiovascular Surgery, Marcus Valve Center, Piedmont Heart Institute, Atlanta, GA, USA.

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http://dx.doi.org/10.21037/acs-2020-mv-108DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7867436PMC
January 2021

Progression of Tricuspid Regurgitation After Surgery for Ischemic Mitral Regurgitation.

J Am Coll Cardiol 2021 Feb;77(6):713-724

Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts, USA.

Background: Whether to repair nonsevere tricuspid regurgitation (TR) during surgery for ischemic mitral valve regurgitation (IMR) remains uncertain.

Objectives: The goal of this study was to investigate the incidence, predictors, and clinical significance of TR progression and presence of ≥moderate TR after IMR surgery.

Methods: Patients (n = 492) with untreated nonsevere TR within 2 prospectively randomized IMR trials were included. Key outcomes were TR progression (either progression by ≥2 grades, surgery for TR, or severe TR at 2 years) and presence of ≥moderate TR at 2 years.

Results: Patients' mean age was 66 ± 10 years (67% male), and TR distribution was 60% ≤trace, 31% mild, and 9% moderate. Among 2-year survivors, TR progression occurred in 20 (6%) of 325 patients. Baseline tricuspid annular diameter (TAD) was not predictive of TR progression. At 2 years, 37 (11%) of 323 patients had ≥moderate TR. Baseline TR grade, indexed TAD, and surgical ablation for atrial fibrillation were independent predictors of ≥moderate TR. However, TAD alone had poor discrimination (area under the curve, ≤0.65). Presence of ≥moderate TR at 2 years was higher in patients with MR recurrence (20% vs. 9%; p = 0.02) and a permanent pacemaker/defibrillator (19% vs. 9%; p = 0.01). Clinical event rates (composite of ≥1 New York Heart Association functional class increase, heart failure hospitalization, mitral valve surgery, and stroke) were higher in patients with TR progression (55% vs. 23%; p = 0.003) and ≥moderate TR at 2 years (38% vs. 22%; p = 0.04).

Conclusions: After IMR surgery, progression of unrepaired nonsevere TR is uncommon. Baseline TAD is not predictive of TR progression and is poorly discriminative of ≥moderate TR at 2 years. TR progression and presence of ≥moderate TR are associated with clinical events. (Comparing the Effectiveness of a Mitral Valve Repair Procedure in Combination With Coronary Artery Bypass Grafting [CABG] Versus CABG Alone in People With Moderate Ischemic Mitral Regurgitation, NCT00806988; Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation, NCT00807040).
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http://dx.doi.org/10.1016/j.jacc.2020.11.066DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7953587PMC
February 2021

Commentary: Transventricular mitral valve repair: Are we ready to move in reverse to repair P2 prolapse?

J Thorac Cardiovasc Surg 2020 Dec 25. Epub 2020 Dec 25.

Department of Cardiovascular Surgery, Marcus Valve Center, Piedmont Heart Institute, Atlanta, Ga. Electronic address:

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http://dx.doi.org/10.1016/j.jtcvs.2020.12.084DOI Listing
December 2020

The International Society for Minimally Invasive Cardiothoracic Surgery Expert Consensus Statement on Transcatheter and Surgical Aortic Valve Replacement in Low- and Intermediate-Risk Patients: A Meta-Analysis of Randomized and Propensity-Matched Studies.

Innovations (Phila) 2021 Jan-Feb;16(1):3-16. Epub 2021 Jan 25.

12264 Division of Cardiac Surgery, University of Maryland School of Medicine, Baltimore, MD, USA.

Objective: There is an increasing amount of evidence supporting use of transcatheter aortic valve replacement (TAVR) for treatment of aortic stenosis in patients at low or intermediate risk for surgical aortic valve replacement (SAVR). TAVR is now approved for use in all patient cohorts. Despite this, there remains debate about the relative efficacy of TAVR compared with SAVR in lower-risk cohorts and various subgroups of patients. We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) and propensity-matched trials to guide a consensus among expert cardiologists and surgeons.

Methods: Studies comparing TAVR and SAVR in low- and intermediate-risk patients were identified by a thorough search of the major databases. Mortality, stroke, and other perioperative outcomes were assessed at 30 days and 1 year.

Results: Early mortality was lower in TAVR compared to SAVR in RCTs, but not propensity-matched studies in low-risk cohorts (0.66% vs 1.5%; odds ratio [OR] = 0.44, 95% confidence interval [CI] 0.20 to 0.98, = 0%). No difference in mortality between TAVR and SAVR was identified in intermediate-risk patients at early or later time points. Incidence of perioperative stroke in 3 low-risk RCTs was significantly lower in TAVR (0.4%) than SAVR (1.4%; OR = 0.33, 95% CI 0.13 to 0.81, = 0%). There was no difference in stroke for intermediate-risk patients between TAVR and SAVR. The expert panel of cardiologists and cardiac surgeons provided recommendations for TAVR and SAVR in various clinical scenarios.

Conclusions: In RCTs comparing TAVR and SAVR in low-risk patients, early mortality and stroke were lower in TAVR, but did not differ at 1 year. There was no difference in mortality and stroke in intermediate-risk patients. The Multidisciplinary Heart Team must consider individual patient characteristics and preferences when recommending TAVR or SAVR. The decision must consider the long-term management of each patient's aortic valve disease.
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http://dx.doi.org/10.1177/1556984520978316DOI Listing
January 2021

Commentary: Robotic aortic valve replacement-fad or future?

J Thorac Cardiovasc Surg 2021 May 15;161(5):1763-1764. Epub 2021 Jan 15.

Department of Cardiovascular Surgery, Marcus Valve Center, Piedmont Heart Institute, Atlanta, Ga. Electronic address:

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http://dx.doi.org/10.1016/j.jtcvs.2020.11.122DOI Listing
May 2021

Commentary: Yes! Size is important when performing aortic valve repair.

J Thorac Cardiovasc Surg 2020 Dec 25. Epub 2020 Dec 25.

Department of Cardiovascular Surgery, Marcus Valve Center, Piedmont Heart Institute, Atlanta, Ga. Electronic address:

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http://dx.doi.org/10.1016/j.jtcvs.2020.12.071DOI Listing
December 2020

First in human experience with an epicardial beating heart device for secondary mitral regurgitation.

J Thorac Cardiovasc Surg 2021 Mar 14;161(3):949-958.e4. Epub 2020 Dec 14.

Baylor Scott & White Heart and Vascular Hospital, Plano, Tex.

Objective: We describe a novel, off-pump, epicardial implant that is intended to reshape both the mitral valve annulus and the left ventricle (LV) in those with secondary mitral regurgitation (MR).

Methods: Five patients underwent an epicardial implant with the Mitral Touch device (Mitre Medical Corp, Morgan Hill, Calif), during concomitant off-pump coronary artery bypass for secondary MR. The median age was 71.2 years; 4 patients had severe MR and 1 moderate. Patients were followed for 1 year with transthoracic echocardiography and computed tomography. Safety, cardiac remodeling, and MR were assessed by an independent core laboratory.

Results: One patient died within 30 days from nondevice-related organ failure and the remaining 4 survived through 1-year follow-up. Implant technical success was 100% and took an average of 52 minutes. Paired computed tomography showed mean left ventricular end-systolic volume remodeling at 1 and 12 months of -35% and -31%, respectively. They averaged left atrial end-systolic volume remodeling of -12% and -15% at 1 and 12 months. Right ventricular end-systolic volume changes of -19% and -8% and right atrial end-systolic volume remodeling of -5% and 1%, at the 1- and 12-month time points were noted. Regurgitant volume by transthoracic echocardiography decreased by 46% and 44% and the ejection fraction from 34.6% to 32.1% and 39.5%, at 1 and 12 months, respectively. There were no device-related complications reported to 1 year.

Conclusions: The Epicardial Mitral Touch System for Mitral Regurgitation (ENRAPT-MR) study demonstrates a first-in-man, off-pump, epicardial repair of secondary MR. Procedural safety and geometric correction of the mitral valve apparatus and LV was achieved. Further studies in the United States are underway.
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http://dx.doi.org/10.1016/j.jtcvs.2020.11.169DOI Listing
March 2021

Aortic Annular Enlargement in the Elderly: Short and Long-Term Outcomes in the United States.

Ann Thorac Surg 2021 Jan 6. Epub 2021 Jan 6.

Division of Thoracic and Cardiovascular Surgery, University of Virginia, Charlottesville, VA. Electronic address:

Background: Patient prosthesis mismatch (PPM) is associated with significant long-term morbidity and mortality after aortic valve replacement, but the role and outcomes of annular enlargement (AE) remains poorly defined. We hypothesized that increasing rates of AE may lead to improved outcomes for patients at risk for severe PPM.

Methods: Patients over age 65 undergoing surgical aortic valve replacement (SAVR) with or without coronary artery bypass grafting from 2008-2016 in the Society of Thoracic Surgeons Adult Cardiac Surgery Database (STS-ACSD) with matching Center for Medicare Services data were included (n=189,268). Univariate, multivariate, and time-to-event analysis was used to evaluate the association between AE and early and late outcomes. Patients were stratified by projected degree of PPM based on calculated effective orifice area index (EOAi).

Results: A total of 5,412 (2.9%) patients underwent AE. STS predicted mortality was similar between AE and non-AE groups (2.97% vs 2.99%, p=0.052). Patients undergoing AE had higher risk-adjusted rates of 30-day complications and death (5.4% vs 3.4%, p<0.0001), but no differences in long-term rates of stroke, heart failure re-hospitalizations or aortic valve reoperation. Survival analysis demonstrated a higher risk of mortality with AE during the first 3 years after which the survival curves cross, favoring AE.

Conclusions: These data suggest annular enlargement during SAVR is associated with increased short-term risk in a Medicare population. Survival curves crossed after three years, which may portend a benefit in select patients. However, annular enlargement is still only done in the minority of patients who are at risk for PPM.
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http://dx.doi.org/10.1016/j.athoracsur.2020.12.023DOI Listing
January 2021

Lower Survival After Coronary Artery Bypass in Patients Who Had Atrial Fibrillation Missed by Widely Used Definitions.

Mayo Clin Proc Innov Qual Outcomes 2020 Dec 10;4(6):630-637. Epub 2020 Dec 10.

Department of Cardiac Surgery, Washington University School of Medicine and Barnes-Jewish Hospital, St Louis, MO.

Objective: To investigate the impact of limiting the definition of post-coronary artery bypass graft (CABG) atrial fibrillation (AF) to AF/flutter requiring treatment-as in the Society of Thoracic Surgeons' (STS) database- on the association with survival.

Patients And Methods: We assessed in-hospital incidence of post-CABG AF in 7110 consecutive isolated patients with CABG without preoperative AF at 4 hospitals (January 1, 2004 to December 31, 2010). Patients with ≥1 episode of post-CABG AF detected via continuous in-hospital electrocardiogram (ECG)/telemetry monitoring documented by physicians were assigned to the following: Group 1, identified as having post-CABG AF in STS data and Group 2, not identified as having post-CABG AF in STS data. Patients without documented post-CABG AF constituted Group 3. Survival was compared via a Cox model, adjusted for STS risk of mortality and accounting for site differences.

Results: Over 7 years' follow-up, 16.0% (295 of 1841) of Group 1, 18.7% (79 of 422) of Group 2, and 7.9% (382 of 4847) of Group 3 died. Group 2 had a significantly greater adjusted risk of death than both Group 1 (hazard ratio [HR]: 1.16; 95% confidence interval [CI], 1.02 to 1.33) and Group 3 (HR: 1.94; 95% CI, 1.69 to 2.22).

Conclusions: The statistically significant 16% higher risk of death for patients with AF post-CABG missed vs captured in STS data suggests treatment and postdischarge management should be investigated for differences. The historical misclassification of "missed" patients as experiencing no AF in the STS data weakens the ability to observe differences in risk between patients with and without post-CABG AF. Therefore, STS data should not be used for research examining post-CABG AF.
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http://dx.doi.org/10.1016/j.mayocpiqo.2020.07.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7749274PMC
December 2020

Diastolic Function and Clinical Outcomes After Transcatheter Aortic Valve Replacement: PARTNER 2 SAPIEN 3 Registry.

J Am Coll Cardiol 2020 12;76(25):2940-2951

Cardiovascular Research Foundation, New York, New York, USA; Columbia University Medical Center, New York-Presbyterian Hospital, New York, New York, USA. Electronic address:

Background: Few studies have evaluated if diastolic function could predict outcomes in patients with aortic stenosis.

Objectives: The authors aimed to assess the association between diastolic dysfunction (DD) and outcomes in patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR).

Methods: Baseline, 30-day, and 1- and 2-year transthoracic echocardiograms from the PARTNER (Placement of Aortic Transcatheter Valves) 2 SAPIEN 3 registry were analyzed by a consortium of core laboratories and divided into the American Society of Echocardiography DD groups.

Results: Among the 1,750 included, 682 (54.4%) had grade 1 DD, 352 (28.1%) had grade 2 DD, 168 (13.4%) had grade 3 DD, and 51 (4.1%) had indeterminate DD grade. Incremental baseline grades of DD were associated with an increase in combined 1- and 2-year cardiovascular (CV) death/rehospitalization (all p < 0.002) and all-cause death at 2 years (p = 0.01) but not at 1 year. Improvement in DD grade/grade 1 DD at 30 days post-TAVR was seen in 70.8% patients. Patients with improvement in ≥1 grade of DD/grade 1 DD had reduced 1-year CV death/rehospitalization (p < 0.001) and increased 2-year survival (p = 0.01). Baseline grade 3 DD was a predictor of 1-year CV death/rehospitalization (hazard ratio: 2.73; 95% confidence interval: 1.07 to 6.98; p = 0.04). Improvement in DD grade/grade 1 DD at 30 days was protective for 1-year CV death/rehospitalizations (hazard ratio: 0.39; 95% confidence interval: 0.19 to 0.83; p = 0.01).

Conclusions: In the PARTNER 2 SAPIEN 3 registry, baseline DD was a predictor of up to 2 years clinical outcomes in patients who underwent TAVR. Improvement in DD grade at 30 days was associated with improvement in short-term clinical outcomes. (The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - PARTNER II - PARTNERII - S3 Intermediate [PARTNERII S3i]; NCT03222128; PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7 [PII S3HR/NR7]; NCT03222141).
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http://dx.doi.org/10.1016/j.jacc.2020.10.032DOI Listing
December 2020

There is no "I" in "TEAM," Unless You Don't Play as Much.

Semin Thorac Cardiovasc Surg 2021 Spring;33(1):59-60. Epub 2020 Nov 26.

Department of Cardiovascular Surgery, Marcus Valve Center, Piedmont Heart Institute, Atlanta, Georgia. Electronic address:

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http://dx.doi.org/10.1053/j.semtcvs.2020.10.030DOI Listing
November 2020

STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement.

Ann Thorac Surg 2021 Feb 16;111(2):701-722. Epub 2020 Nov 16.

Division of Cardiovascular Surgery, University of Pennsylvania, Philadelphia, Pennsylvania.

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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http://dx.doi.org/10.1016/j.athoracsur.2020.09.002DOI Listing
February 2021

STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement.

J Am Coll Cardiol 2020 11;76(21):2492-2516

Division of Cardiovascular Surgery, University of Pennsylvania, Philadelphia, Pennsylvania.

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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http://dx.doi.org/10.1016/j.jacc.2020.09.595DOI Listing
November 2020

Surgical Valve Prosthesis Choices: Choose for the Now, But Don't Forget About the Future.

Ann Thorac Surg 2021 04 16;111(4):1206. Epub 2020 Nov 16.

Department of Cardiovascular Surgery, Marcus Heart and Vascular Center, Piedmont Heart Institute, 95 Collier Rd, Ste 5015, Atlanta, GA 30309. Electronic address:

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http://dx.doi.org/10.1016/j.athoracsur.2020.08.088DOI Listing
April 2021

First Report of SAPIEN 3 in Lotus: TAVR-in-TAVR With SAPIEN 3 Inside Degenerated Lotus Valve.

JACC Cardiovasc Interv 2020 11 28;13(22):2704-2707. Epub 2020 Oct 28.

Department of Cardiovascular Surgery, Marcus Heart Valve Center, Piedmont Heart Institute, Atlanta, Georgia.

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http://dx.doi.org/10.1016/j.jcin.2020.09.010DOI Listing
November 2020