Publications by authors named "Joanna Chikwe"

178 Publications

Long-term outcomes after heart transplantation using ex vivo allograft perfusion in standard risk donors: A single-center experience.

Clin Transplant 2022 Jan 14:e14591. Epub 2022 Jan 14.

Department of Cardiac Surgery, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.

Introduction: The Organ Care System (OCS) is an ex vivo perfusion platform for donor heart preservation. Short/mid-term post-transplant outcomes after its use are comparable to standard cold storage (CS). We evaluated long-term outcomes following its use.

Methods: Between 2011 and 2013, 38 patients from a single center were randomized as a part of the PROCEED II trial to receive allografts preserved with CS (n = 19) or OCS (n = 19). Endpoints included 8-year survival, survival free from graft-related deaths, freedom from cardiac allograft vasculopathy (CAV), non-fatal major adverse cardiac events (NF-MACE), and rejections.

Results: Eight-year survival was 57.9% in the OCS group and 73.7% in the CS group (p = .24). Freedom from CAV was 89.5% in the OCS group and 67.8% in the CS group (p = .13). Freedom from NF-MACE was 89.5% in the OCS group and 67.5% in the CS group (p = .14). Eight-year survival free from graft-related death was equivalent between the two groups (84.2% vs. 84.2%, p = .93). No differences in rejection episodes were observed (all p > .5).

Conclusions: In select patients receiving OCS preserved allografts, late post-transplant survival trended lower than those transplanted with an allograft preserved with CS. This is based on a small single-center series, and larger numbers are needed to confirm these findings.
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http://dx.doi.org/10.1111/ctr.14591DOI Listing
January 2022

Optimal circulatory arrest temperature for aortic hemiarch replacement with antegrade brain perfusion.

J Thorac Cardiovasc Surg 2021 Nov 12. Epub 2021 Nov 12.

Division of Cardiac Surgery, Department of Cardiothoracic Surgery, University of Pittsburgh School of Medicine, Pittsburgh, Pa; University of Pittsburgh Medical Center Heart and Vascular Institute, Pittsburgh, Pa. Electronic address:

Objective: This study sought to identify the optimal temperature for moderate hypothermic circulatory arrest in patients undergoing elective hemiarch replacement with antegrade brain perfusion.

Methods: The Society of Thoracic Surgeons adult cardiac surgery database was queried for elective hemiarch replacements using antegrade brain perfusion for aneurysmal disease (2014-2019). Generalized estimating equations and restricted cubic splines were used to determine the risk-adjusted relationships between temperature as a continuous variable and outcomes.

Results: Elective hemiarch replacement with antegrade brain perfusion occurred in 3898 patients at 374 centers with a median nadir temperature of 24.9 °C (first quartile, third quartile = 22.0 °C, 27.5 °C) and median circulatory arrest time of 19 minutes (first quartile, third quartile = 14.0 minutes, 27.0 minutes). After adjustment for comorbidities, circulatory arrest time, and individual surgeon, patients cooled between 25 and 28 °C had an early survival advantage compared with 24 °C, whereas those cooled between 21 and 23 °C had higher risks of mortality compared with 24 °C. A nadir temperature of 27 °C was associated with the lowest risk-adjusted odds of mortality (odds ratio, 0.62; 95% confidence interval, 0.42-0.91). A nadir temperature of 21 °C had the highest risk of mortality (odds ratio, 1.4; 95% confidence interval, 1.13-1.73). Risk of experiencing a major morbidity was elevated in patients cooled between 21 and 23 °C, with the highest risk occurring in patients cooled to 21 °C (odds ratio, 1.12; 95% confidence interval, 1.01-1.24).

Conclusions: For patients with aneurysmal disease undergoing elective hemiarch with antegrade brain perfusion, circulatory arrest with a nadir temperature of 27 °C confers the greatest early survival benefit and smallest risk of postoperative morbidity.
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http://dx.doi.org/10.1016/j.jtcvs.2021.09.068DOI Listing
November 2021

Methodological Standards for the Design, Implementation, and Analysis of Randomized Trials in Cardiac Surgery: A Scientific Statement From the American Heart Association.

Circulation 2022 Jan 6;145(4):e129-e142. Epub 2021 Dec 6.

Cardiac surgery presents specific methodological challenges in the design, implementation, and analysis of randomized controlled trials. The purposes of this scientific statement are to review key standards in cardiac surgery randomized trial design and implementation, and to provide recommendations for conducting and interpreting cardiac surgery trials. Recommendations include a careful evaluation of the suitability of the research question for a clinical trial, assessment of clinical equipoise, feasibility of enrolling a representative patient cohort, impact of practice variations on the safety and efficacy of the study intervention, likelihood and impact of crossover, and duration of follow-up. Trial interventions and study end points should be predefined, and appropriate strategies must be used to ensure adequate deliverability of the trial interventions. Every effort must be made to ensure a high completeness of follow-up; trial design and analytic techniques must be tailored to the specific research question and trial setting.
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http://dx.doi.org/10.1161/CIR.0000000000001037DOI Listing
January 2022

Posterior left pericardiotomy for the prevention of atrial fibrillation after cardiac surgery: an adaptive, single-centre, single-blind, randomised, controlled trial.

Lancet 2021 12 14;398(10316):2075-2083. Epub 2021 Nov 14.

Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, NY, USA.

Background: Atrial fibrillation is the most common complication after cardiac surgery and is associated with extended in-hospital stay and increased adverse outcomes, including death and stroke. Pericardial effusion is common after cardiac surgery and can trigger atrial fibrillation. We tested the hypothesis that posterior left pericardiotomy, a surgical manoeuvre that drains the pericardial space into the left pleural cavity, might reduce the incidence of atrial fibrillation after cardiac surgery.

Methods: In this adaptive, randomised, controlled trial, we recruited adult patients (aged ≥18 years) undergoing elective interventions on the coronary arteries, aortic valve, or ascending aorta, or a combination of these, performed by members of the Department of Cardiothoracic Surgery from Weill Cornell Medicine at the New York Presbyterian Hospital in New York, NY, USA. Patients were eligible if they had no history of atrial fibrillation or other arrhythmias or contraindications to the experimental intervention. Eligible patients were randomly assigned (1:1), stratified by CHADS-VASc score and using a mixed-block randomisation approach (block sizes of 4, 6, and 8), to posterior left pericardiotomy or no intervention. Patients and assessors were blinded to treatment assignment. Patients were followed up until 30 days after hospital discharge. The primary outcome was the incidence of atrial fibrillation during postoperative in-hospital stay, which was assessed in the intention-to-treat (ITT) population. Safety was assessed in the as-treated population. This study is registered with ClinicalTrials.gov, NCT02875405, and is now complete.

Findings: Between Sept 18, 2017, and Aug 2, 2021, 3601 patients were screened and 420 were included and randomly assigned to the posterior left pericardiotomy group (n=212) or the no intervention group (n=208; ITT population). The median age was 61·0 years (IQR 53·0-70·0), 102 (24%) patients were female, and 318 (76%) were male, with a median CHADS-VASc score of 2·0 (IQR 1·0-3·0). The two groups were balanced with respect to clinical and surgical characteristics. No patients were lost to follow-up and data completeness was 100%. Three patients in the posterior left pericardiotomy group did not receive the intervention. In the ITT population, the incidence of postoperative atrial fibrillation was significantly lower in the posterior left pericardiotomy group than in the no intervention group (37 [17%] of 212 vs 66 [32%] of 208 [p=0·0007]; odds ratio adjusted for the stratification variable 0·44 [95% CI 0·27-0·70; p=0·0005]). Two (1%) of 209 patients in the posterior left pericardiotomy group and one (<1%) of 211 in the no intervention group died within 30 days after hospital discharge. The incidence of postoperative pericardial effusion was lower in the posterior left pericardiotomy group than in the no intervention group (26 [12%] of 209 vs 45 [21%] of 211; relative risk 0·58 [95% CI 0·37-0·91]). Postoperative major adverse events occurred in six (3%) patients in the posterior left pericardiotomy group and in four (2%) in the no intervention group. No posterior left pericardiotomy related complications were seen.

Interpretation: Posterior left pericardiotomy is highly effective in reducing the incidence of atrial fibrillation after surgery on the coronary arteries, aortic valve, or ascending aorta, or a combination of these without additional risk of postoperative complications.

Funding: None.
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http://dx.doi.org/10.1016/S0140-6736(21)02490-9DOI Listing
December 2021

The optimal strategy for multivessel coronary revascularization.

Eur Heart J 2021 Nov 11. Epub 2021 Nov 11.

Department of Cardiac Surgery, S. Raffaele University Hospital, Milan, Italy.

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http://dx.doi.org/10.1093/eurheartj/ehab768DOI Listing
November 2021

Association of Volume and Outcomes in 234,556 Patients Undergoing Surgical Aortic Valve Replacement.

Ann Thorac Surg 2021 Nov 13. Epub 2021 Nov 13.

Department of Cardiac Surgery, Ottawa Heart Institute, Canada.

Background: The relationship between institutional volume and operative mortality following SAVR remains unclear.

Methods: From 1/2013 to 6/2018, 234,556 patients underwent isolated SAVR (n=144,177) or SAVR+CABG (n=90,379) within the STS ACSD. The association between annualized SAVR volume [Group 1 (1-25 SAVR), Group 2 (26-50 SAVR), Group 3 (51-100 SAVR), and Group 4 (>100 SAVR)] and operative mortality and composite major morbidity/mortality was assessed. Random effects models were used to evaluate whether historic (2013-2015) SAVR volume or risk-adjusted outcomes explained future (2016-2018) risk-adjusted outcomes.

Results: The annualized median number of SAVRs per site was 35 [IQR: 22-59, isolated AVR: 20, AVR+CABG: 13]. Among isolated SAVR cases, the mean operative mortality and composite morbidity/mortality were 1.5% and 9.7%, respectively, at the highest volume sites (Group 4); with significantly higher rates among progressively lower volume groups (p-trend<0.001). After adjustment, lower volume centers experienced increased odds of operative mortality [Group 1 vs. 4 (Ref): AOR (SAVR), 2.24 (1.91-2.64); AOR (SAVR+CABG), 1.96 (1.67-2.30)] and major morbidity/mortality [AOR (SAVR), 1.53 (1.39-1.69); AOR (SAVR+CABG), 1.46 (1.32-1.61)] compared to the highest volume institutions. Substantial variation in outcomes was observed across hospitals within each volume category and prior outcomes explained a greater proportion of hospital operative outcomes than prior volume.

Conclusions: Operative outcomes following SAVR±CABG is inversely associated with institutional procedure volumes; however, prior outcomes are more predictive than prior volume of future outcomes. Given excellent outcomes observed at many lower volume hospitals, procedural outcomes may be preferable to procedural volumes as a quality metric.
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http://dx.doi.org/10.1016/j.athoracsur.2021.06.095DOI Listing
November 2021

The Association of Socio-Economic Factors with Outcomes for Coronary Artery Bypass Surgery.

Ann Thorac Surg 2021 Nov 11. Epub 2021 Nov 11.

Department of Cardiothoracic Surgery, Drexel University, Philadelphia. PA.

Background: Numerous studies have identified the associations of socio-economic factors with outcomes of cardiac procedures. The majority have focused on easily measured factors like sex, race, and insurance status, or on socio-economic characteristics of patients' 5-digit zip codes. The impact of more granular census-derived socio-economic information on outcomes has rarely been studied.

Methods: The independent impact of the Area Deprivation Index (ADI) on short-term mortality and readmissions was tested on patients undergoing isolated coronary artery bypass graft (CABG) surgery in New York by using it in logistic regression models in conjunction with patient risk factors and typical disparities measures (race, ethnicity, payer). Changes in hospitals' risk-adjusted outcomes and outlier status with the addition of socio-economic measures were also tested.

Results: After adjusting for numerous patient characteristics, patients in the fourth and fifth highest ADI quintiles (most deprived) were more likely to experience in-hospital/30-day mortality following CABG surgery (AOR = 1.54 (1.08, 2.20) and AOR = 1.50 (1.02, 2.21)), respectively. ADI was not associated with readmissions, but African Americans (AOR = 1.49 (1.18, 1.87)), Hispanics (AOR = 1.33 (1.06, 1.65)) and Medicaid patients (AOR = 1.34 (1.09, 1.64)) were more likely to be readmitted.

Conclusions: Patients with high ADIs are more likely to experience short-term mortality following CABG surgery. African Americans, Hispanics and Medicaid patients are more likely to experience 30-day readmissions. This information should be taken into account when monitoring patients to reduce adverse events following surgery, and more studies related to ADI are needed to fully understand its implications.
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http://dx.doi.org/10.1016/j.athoracsur.2021.10.006DOI Listing
November 2021

The Price of Freedom from Tricuspid Regurgitation.

N Engl J Med 2022 Jan 13;386(4):389-390. Epub 2021 Nov 13.

From the Department of Cardiac Surgery, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (J.C.), and the Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York (M.G.).

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http://dx.doi.org/10.1056/NEJMe2116776DOI Listing
January 2022

Outcomes of Venoarterial Extracorporeal Membrane Oxygenation for Cardiac Arrest in Adult Patients in the United States.

J Am Heart Assoc 2021 10 11;10(20):e021406. Epub 2021 Oct 11.

Division of Cardiology, Department of Medicine Stony Brook University Medical Center Stony Brook NY.

Background Factors associated with poor prognosis following receipt of extracorporeal membrane oxygenation (ECMO) in adults with cardiac arrest remain unclear. We aimed to identify predictors of mortality in adults with cardiac arrest receiving ECMO in a nationally representative sample. Methods and Results The US Healthcare Cost and Utilization Project's National Inpatient Sample was used to identify 782 adults hospitalized with cardiac arrest who received ECMO between 2006 and 2014. The primary outcome of interest was all-cause in-hospital mortality. Factors associated with mortality were analyzed using multivariable logistic regression. The overall in-hospital mortality rate was 60.4% (n=472). Patients who died were older and more often men, of non-White race, and with lower household income than those surviving to discharge. In the risk-adjusted analysis, independent predictors of mortality included older age, male sex, lower annual income, absence of ventricular arrhythmia, absence of percutaneous coronary intervention, and presence of therapeutic hypothermia. Conclusions Demographic and therapeutic factors are independently associated with mortality in patients with cardiac arrest receiving ECMO. Identification of which patients with cardiac arrest may receive the utmost benefit from ECMO may aid with decision-making regarding its implementation. Larger-scale studies are warranted to assess the appropriate candidates for ECMO in cardiac arrest.
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http://dx.doi.org/10.1161/JAHA.121.021406DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8751900PMC
October 2021

Ischemic mitral regurgitation: when should one intervene?

Curr Opin Cardiol 2021 11;36(6):755-763

Division of Cardiac Surgery, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.

Purpose Of Review: Optimal timing of intervention for ischemic mitral regurgitation remains to be elucidated. This review summarizes the data on the management of ischemic mitral regurgitation, and their implications on current practice and future research.

Recent Findings: Mechanistically, ischemic mitral regurgitation can present as Type I, Type IIIb or mixed Type I and IIIb disease. Severity of mitral regurgitation is typically quantified with echocardiography, either transthoracic or transesophageal echocardiography, but may also be assessed via cardiac MRI. In patients with moderate ischemic mitral regurgitation, revascularization can lead to left ventricular reverse remodeling in some. In patients with severe ischemic mitral regurgitation, mitral valve replacement may be associated with fewer adverse events related to heart failure and cardiovascular readmissions, compared with valve repair, although reverse remodeling may be better in patients following successful mitral repair. Transcatheter edge-to-edge repair also further complements the treatment of ischemic mitral regurgitation.

Summary: A tailored approach to patients should be considered for each patient presenting with ischemic mitral regurgitation.
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http://dx.doi.org/10.1097/HCO.0000000000000916DOI Listing
November 2021

Contemporary Left Ventricular Assist Device Outcomes in an Aging Population: An STS INTERMACS Analysis.

J Am Coll Cardiol 2021 08;78(9):883-894

Kirklin Institute for Research in Surgical Outcomes (KIRSO), Department Surgery, University of Alabama at Birmingham, Birmingham, Alabama, USA.

Background: Survival, functional outcomes, and quality of life after left ventricular assist device (LVAD) are ill-defined in elderly patients, and with new-generation devices.

Objectives: This study sought to evaluate survival, functional outcomes, and quality of life after LVAD in contemporary practice.

Methods: Adults receiving durable LVADs between January 1, 2010, and March 1, 2020, were identified from the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) database. The primary outcome was adjusted survival; secondary outcomes included quality of life rated using a visual analogue scale (where 0 represents "worst health" and 100 "best health"); 6-minute walk distance; stroke; device malfunction; and rehospitalization, stratified by patient age. Median follow-up was 15 months (IQR: 6-32 months).

Results: The cohort comprised 68.9% (n = 16,808) patients aged <65 years, 26.3% (n = 6,418) patients aged 65-75 years, and 4.8% (n = 1,182) patients aged >75 years, who were predominantly male (n = 19,119, 78%) and on destination therapy (n = 12,425, 51%). Competing outcomes analysis demonstrated mortality (70% CIs) of 34% (33%-34%), 54% (54%-55%), and 66% (64%-68%) for patients aged <65, 65-75, and >75 years, respectively, which improved during the study in patients aged >75 years. Newer-generation devices were associated with reduced late mortality (HR: 0.35; 95% CI: 0.25-0.49). Stroke, device malfunction or thrombosis, and rehospitalizations decreased with increasing age (all P < 0.01). Median 6-minute walk distance increased from 0 feet (IQR: 0-665 feet) to 1,065 feet (IQR: 642-1,313 feet) (P < 0.001), and quality of life improved from 40 (IQR: 15-60) to 75 (IQR: 60-90) (P < 0.001) after LVAD in all age groups.

Conclusions: In elderly patients, LVADs are associated with increased functional capacity, similar improvements in quality of life, and fewer complications compared with younger patients.
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http://dx.doi.org/10.1016/j.jacc.2021.06.035DOI Listing
August 2021

Durable Robotic Mitral Repair of Degenerative Primary Regurgitation With Long-Term Follow-Up.

Ann Thorac Surg 2021 Aug 23. Epub 2021 Aug 23.

Department of Cardiac Surgery, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California. Electronic address:

Background: Variation in degenerative mitral morphology may contribute to suboptimal repair rates. This study evaluates outcomes of a standardized mitral repair technique.

Methods: An institutional clinical registry was used to identify 1036 consecutive patients undergoing robotic mitral surgery between 2005 and 2020: 87% (n = 902) had degenerative disease. Calcification, failed transcatheter repair, and endocarditis were excluded, leaving 582 (68%) patients with isolated posterior leaflet and 268 (32%) with anterior or bileaflet prolapse. Standardized repair comprised triangular resection and true-sized flexible band in posterior leaflet prolapse. Freedom from greater than 2+ moderate mitral regurgitation stratified by prolapse location was assessed using competing risk analysis with death as a competing event. Median follow-up was 5.5 (range 0-15) years.

Results: Of patients with isolated posterior leaflet prolapse, 87% (n = 506) had standardized repairs and 13% (n = 76) had additional or nonresectional techniques vs 24% (n = 65) and 76% (n = 203), respectively, for anterior or bileaflet prolapse (P < .001). Adjunctive techniques in the isolated posterior leaflet group included chordal reconstruction (8.6%, n = 50) and commissural sutures (3.4%, n = 20). Overall, median clamp time was 80 (interquartile range, 68-98) minutes, 17 patients required intraoperative re-repair, and 6 required mitral replacement. Freedom from greater than 2+ regurgitation or reintervention at 10 years was 92% for posterior prolapse (vs 83% for anterior or bileaflet prolapse). Anterior or bileaflet prolapse was associated with late greater than 2+ regurgitation (hazard ratio, 3.0; 95% confidence interval, 1.3-7.0).

Conclusions: Posterior leaflet prolapse may be repaired in greater than 99% of patients using triangular resection and band annuloplasty, with satisfactory long-term durability. Increased risk of complex repairs and inferior durability highlights the value of identifying anterior and bileaflet prolapse preoperatively.
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http://dx.doi.org/10.1016/j.athoracsur.2021.07.060DOI Listing
August 2021

Sex differences in outcomes after coronary artery bypass grafting: a pooled analysis of individual patient data.

Eur Heart J 2021 12;43(1):18-28

Bristol Heart Institute, University of Bristol, Terrell St, Bristol BS2 8ED, UK.

Aims: Data suggest that women have worse outcomes than men after coronary artery bypass grafting (CABG), but results have been inconsistent across studies. Due to the large differences in baseline characteristics between sexes, suboptimal risk adjustment due to low-quality data may be the reason for the observed differences. To overcome this limitation, we undertook a systematic review and pooled analysis of high-quality individual patient data from large CABG trials to compare the adjusted outcomes of women and men.

Methods And Results: The primary outcome was a composite of all-cause mortality, myocardial infarction (MI), stroke, and repeat revascularization (major adverse cardiac and cerebrovascular events, MACCE). The secondary outcome was all-cause mortality. Multivariable mixed-effect Cox regression was used. Four trials involving 13 193 patients (10 479 males; 2714 females) were included. Over 5 years of follow-up, women had a significantly higher risk of MACCE [adjusted hazard ratio (HR) 1.12, 95% confidence interval (CI) 1.04-1.21; P = 0.004] but similar mortality (adjusted HR 1.03, 95% CI 0.94-1.14; P = 0.51) compared to men. Women had higher incidence of MI (adjusted HR 1.30, 95% CI 1.11-1.52) and repeat revascularization (adjusted HR 1.22, 95% CI 1.04-1.43) but not stroke (adjusted HR 1.17, 95% CI 0.90-1.52). The difference in MACCE between sexes was not significant in patients 75 years and older. The use of off-pump surgery and multiple arterial grafting did not modify the difference between sexes.

Conclusions: Women have worse outcomes than men in the first 5 years after CABG. This difference is not significant in patients aged over 75 years and is not affected by the surgical technique.
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http://dx.doi.org/10.1093/eurheartj/ehab504DOI Listing
December 2021

Atrial Septal Defect Closure Device-Related Infective Endocarditis in a 20-Week Pregnant Woman.

JACC Case Rep 2021 Feb 17;3(2):300-303. Epub 2021 Feb 17.

Division of Cardiovascular Medicine, Department of Medicine, State University of New York at Stony Brook, Stony Brook, New York, USA.

With increasing atrial septal defect (ASD) repairs, more women of childbearing age will have ASD closure devices. Current ASD closure trials have excluded women planning pregnancy, making their management challenging. We present a pregnant woman, with a repaired ASD, who presented with device-related infective endocarditis. ().
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http://dx.doi.org/10.1016/j.jaccas.2020.09.057DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8310939PMC
February 2021

Commentary: Signal or noise?

Authors:
Joanna Chikwe

J Thorac Cardiovasc Surg 2021 Jul 7. Epub 2021 Jul 7.

Department of Cardiac Surgery, Cedars-Sinai Medical Center, Smidt Heart Institute, Los Angeles, Calif. Electronic address:

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http://dx.doi.org/10.1016/j.jtcvs.2021.06.006DOI Listing
July 2021

Robotic mitral valve repair following failed transcatheter edge-to-edge repair.

Ann Thorac Surg 2021 Jun 28. Epub 2021 Jun 28.

Department of Cardiac Surgery, Cedars-Sinai, Los Angeles, USA. Electronic address:

Mitral valve repair is infrequently performed in patients undergoing corrective surgery for failed mitral transcatheter edge-to-edge repair (TEER) in current US practice. This article describes surgical techniques for reconstructive surgery following failed TEER. A total of nine patients underwent robotic-assisted mitral surgery following failed TEER between 2010 and 2020 at a single center. Repair was completed in 88.9% (n=8) patients and freedom from >2+ mitral regurgitation was 87.5% (n=7) at a median follow up of 1.9 years.
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http://dx.doi.org/10.1016/j.athoracsur.2021.05.083DOI Listing
June 2021

Characteristics of Randomized Clinical Trials in Surgery From 2008 to 2020: A Systematic Review.

JAMA Netw Open 2021 06 1;4(6):e2114494. Epub 2021 Jun 1.

Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, New York.

Importance: Randomized clinical trials (RCTs) provide the highest level of evidence to evaluate 2 or more surgical interventions. Surgical RCTs, however, face unique challenges in design and implementation.

Objective: To evaluate the design, conduct, and reporting of contemporary surgical RCTs.

Evidence Review: A literature search performed in the 2 journals with the highest impact factor in general medicine as well as 6 key surgical specialties was conducted to identify RCTs published between 2008 and 2020. All RCTs describing a surgical intervention in both experimental and control arms were included. The quality of included data was assessed by establishing an a priori protocol containing all the details to extract. Trial characteristics, fragility index, risk of bias (Cochrane Risk of Bias 2 Tool), pragmatism (Pragmatic Explanatory Continuum Indicator Summary 2 [PRECIS-2]), and reporting bias were assessed.

Findings: A total of 388 trials were identified. Of them, 242 (62.4%) were registered; discrepancies with the published protocol were identified in 81 (33.5%). Most trials used superiority design (329 [84.8%]), and intention-to-treat as primary analysis (221 [56.9%]) and were designed to detect a large treatment effect (50.0%; interquartile range [IQR], 24.7%-63.3%). Only 123 trials (31.7%) used major clinical events as the primary outcome. Most trials (303 [78.1%]) did not control for surgeon experience; only 17 trials (4.4%) assessed the quality of the intervention. The median sample size was 122 patients (IQR, 70-245 patients). The median follow-up was 24 months (IQR, 12.0-32.0 months). Most trials (211 [54.4%]) had some concern of bias and 91 (23.5%) had high risk of bias. The mean (SD) PRECIS-2 score was 3.52 (0.65) and increased significantly over the study period. Most trials (212 [54.6%]) reported a neutral result; reporting bias was identified in 109 of 211 (51.7%). The median fragility index was 3.0 (IQR, 1.0-6.0). Multiplicity was detected in 175 trials (45.1%), and only 35 (20.0%) adjusted for multiple comparisons.

Conclusions And Relevance: In this systematic review, the size of contemporary surgical trials was small and the focus was on minor clinical events. Trial registration remained suboptimal and discrepancies with the published protocol and reporting bias were frequent. Few trials controlled for surgeon experience or assessed the quality of the intervention.
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http://dx.doi.org/10.1001/jamanetworkopen.2021.14494DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8246313PMC
June 2021

Mitral Valve Replacement: Still a Durable Option.

Ann Thorac Surg 2021 Jun 21. Epub 2021 Jun 21.

Department of Cardiac Surgery, Smidt Heart Institute, Cedars-Sinai Medical Center, 127 S San Vicente Blvd., Los Angeles, CA 90048.

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http://dx.doi.org/10.1016/j.athoracsur.2021.05.066DOI Listing
June 2021

Mechanical Complications of Acute Myocardial Infarction: A Scientific Statement From the American Heart Association.

Circulation 2021 07 15;144(2):e16-e35. Epub 2021 Jun 15.

Over the past few decades, advances in pharmacological, catheter-based, and surgical reperfusion have improved outcomes for patients with acute myocardial infarctions. However, patients with large infarcts or those who do not receive timely revascularization remain at risk for mechanical complications of acute myocardial infarction. The most commonly encountered mechanical complications are acute mitral regurgitation secondary to papillary muscle rupture, ventricular septal defect, pseudoaneurysm, and free wall rupture; each complication is associated with a significant risk of morbidity, mortality, and hospital resource utilization. The care for patients with mechanical complications is complex and requires a multidisciplinary collaboration for prompt recognition, diagnosis, hemodynamic stabilization, and decision support to assist patients and families in the selection of definitive therapies or palliation. However, because of the relatively small number of high-quality studies that exist to guide clinical practice, there is significant variability in care that mainly depends on local expertise and available resources.
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http://dx.doi.org/10.1161/CIR.0000000000000985DOI Listing
July 2021

Gender Representation Among Principal Investigators in Cardiac Surgery Clinical Trials in the United States: The Glass Ceiling and Room for Improvement.

Ann Surg 2021 Jun 2. Epub 2021 Jun 2.

Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada Division of Cardiovascular Surgery, Department of Surgery, University of British Columbia, Vancouver, British Columbia, Canada Division of Cardiac Surgery, Department of Surgery, John Hopkins University, Baltimore, MD Department of Cardiac Surgery, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA Division of Cardiothoracic Surgery, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX Division of Cardiothoracic Surgery, Michael E. DeBakey VA Medical Center, Houston, TX Department of Cardiothoracic and Vascular Surgery, Cardiothoracic Surgery Section, University of Texas Health Science Center Houston, McGovern Medical School, Houston, TX Division of Cardiothoracic Surgery, Department of Surgery, Washington University School of Medicine at Barnes-Jewish Hospital, St. Louis, MO Department of Cardiovascular Surgery, Texas Heart Institute, Houston, TX.

Objective: To determine the gender representation among principal investigators (PIs) in US cardiac surgery clinical trials.

Summary Background Data: Being a principal investigator in a US clinical trial confers national recognition among peers. Gender representation among principal investigators (PIs) in US cardiac surgery clinical trials has not been evaluated.

Methods: We evaluated 124 US cardiac surgery trials registered on ClinicalTrials.gov from 2014 to 2019. Sixty trials included PIs (n = 266) from 128 institutions that had a combined total of 1040 adult cardiac surgeons. We examined gender representation among junior-level (instructor or assistant professor) and senior-level (associate, full, or Emeritus professor) PIs by calculating the participation-to-prevalence ratio (PPR), whereby a PPR range of 0.8-1.2 reflects equitable representation.

Results: The pool representation percentage was 6.1% (63/1040) for women and 93.9% (977/1040) for men. A total of 266 PI positions were assigned to adult cardiac surgeons: 6 (9.5%; PPR = 0.37) from the female pool and 260 (26.6%; PPR = 1.04) from the male pool (p = 0.004). The percentage of PIs with studies funded by industry was 9.5% of the female pool (PPR = 0.39) and 25.0% of the male pool (PPR = 1.04) (p = 0.009). No National Institutes of Health-funded or other funded trials had female PIs. An overall trend was observed towards disproportionally more men than women among PIs, especially at the senior level (p = 0.027).

Conclusions: Equitable opportunities for PI positions are available for junior-level but not senior-level cardiothoracic surgeons. These results suggest a need for active engagement and promotion of equal opportunities in cardiac surgery.
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http://dx.doi.org/10.1097/SLA.0000000000004961DOI Listing
June 2021

Aortic Endocarditis: Further Evidence for Early Surgical Intervention.

Ann Thorac Surg 2022 02 26;113(2):543-544. Epub 2021 May 26.

Department of Cardiac Surgery, Smidt Heart Institute, Cedars-Sinai Medical Center, 127 S San Vicente Blvd, Los Angeles, CA 90048.

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http://dx.doi.org/10.1016/j.athoracsur.2021.05.003DOI Listing
February 2022

Mitral Surgery After Transcatheter Edge-to-Edge Repair: Society of Thoracic Surgeons Database Analysis.

J Am Coll Cardiol 2021 07 1;78(1):1-9. Epub 2021 May 1.

Department of Cardiovascular Surgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA.

Background: Transcatheter edge-to-edge (TEER) mitral repair may be complicated by residual or recurrent mitral regurgitation. An increasing need for surgical reintervention has been reported, but operative outcomes are ill defined.

Objectives: This study evaluated national outcomes of mitral surgery after TEER.

Methods: The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database was used to identify 524 adults who underwent mitral surgery after TEER between July 2014 and June 2020. Emergencies (5.0%; n = 26), previous mitral surgery (5.3%; n = 28), or open implantation of transcatheter prostheses (1.5%; n = 8) were excluded. The primary outcome was 30-day or in-hospital mortality.

Results: In the study cohort of 463 patients, the median age was 76 years (interquartile range [IQR]: 67 to 81 years), median left ventricular ejection fraction was 57% (IQR: 48% to 62%), and 177 (38.2%) patients had degenerative disease. Major concomitant cardiac surgery was performed in 137 (29.4%) patients: in patients undergoing isolated mitral surgery, the median STS-predicted mortality was 6.5% (IQR: 3.9% to 10.5%), the observed mortality was 10.2% (n = 23 of 225), and the ratio of observed to expected mortality was 1.2 (95% confidence interval [CI]: 0.8 to 1.9). Predictors of mortality included urgent surgery (odds ratio [OR]: 2.4; 95% CI: 1.3 to 4.6), nondegenerative/unknown etiology (OR: 2.2; 95% CI: 1.1 to 4.5), creatinine of >2.0 mg/dl (OR: 3.8; 95% CI: 1.9 to 7.9) and age of >80 years (OR: 2.1; 95% CI: 1.1 to 4.4). In a volume outcomes analysis in an expanded cohort of 591 patients at 227 hospitals, operative mortality was 2.6% (n = 2 of 76) in 4 centers that performed >10 cases versus 12.4% (n = 64 of 515) in centers performing fewer (p = 0.01). The surgical repair rate after failed TEER was 4.8% (n = 22) and was 6.8% (n = 12) in degenerative disease.

Conclusions: This study indicates that mitral repair is infrequently achieved after failed TEER, which may have implications for treatment choice in lower-risk and younger patients with degenerative disease. These findings should inform patient consent for TEER, clinical trial design, and clinical performance measures.
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http://dx.doi.org/10.1016/j.jacc.2021.04.062DOI Listing
July 2021

Commentary: The importance of surgical case volume in the transcatheter era.

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

Department of Cardiac Surgery, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, Calif. Electronic address:

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http://dx.doi.org/10.1016/j.jtcvs.2020.07.076DOI Listing
July 2020

Venous bullet embolism to the right ventricle: Case report and review of management.

Clin Case Rep 2021 Feb 24;9(2):917-921. Epub 2020 Dec 24.

Department of Cardiothoracic Surgery Smidt Heart Institute Cedars-Sinai Medical Center Los Angeles CA USA.

Intravascular missile emboli to the right heart should be retrieved surgically if the risk of surgical complication due to sternotomy and cardiotomy is low. Endovascular retrieval is another possible method of extraction to be considered.
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http://dx.doi.org/10.1002/ccr3.3284DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7869315PMC
February 2021

Commentary: The problem of valve prosthesis-patient mismatch revisited.

J Thorac Cardiovasc Surg 2020 Dec 5. Epub 2020 Dec 5.

Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, Calif.

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http://dx.doi.org/10.1016/j.jtcvs.2020.11.145DOI Listing
December 2020

Challenges to Randomized Trials in Adult and Congenital Cardiac and Thoracic Surgery.

Ann Thorac Surg 2021 Jan 4. Epub 2021 Jan 4.

Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, New York.

Randomized trials in surgery face additional challenges compared with those in medicine. Some of the challenges are intrinsic to the nature of the field (eg, issues with blinding, learning curve and surgeons' experience, and difficulties in defining the appropriate timing for comparative trials). Other issues are related to the surgical culture, the attitude of surgeons toward randomized trials, and the lack of support by professional and national bodies. In this review, a group of investigators with experience in trials in congenital and adult cardiac and thoracic surgery discusses the key issues with surgical trials and suggests potential solutions.
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http://dx.doi.org/10.1016/j.athoracsur.2020.11.042DOI Listing
January 2021
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