Publications by authors named "Eugene H Blackstone"

569 Publications

Aortic allograft infection risk.

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

Department of Thoracic and Cardiovascular Surgery, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Objective: Intrinsic risk of infection of cryopreserved allograft aortic root replacements remains poorly understood despite their long history of use. The objective of this study was to determine this intrinsic risk of allograft infection and its risk factors when allografts are implanted for both nonendocarditis indications and infective endocarditis.

Methods: From January 1987 to January 2017, 2042 patients received 2110 allograft aortic valves at a quaternary medical center, 1124 (53%) for nonendocarditis indications and 986 (47%) for endocarditis indications (670 [68%] prosthetic valve endocarditis). Staphylococcus aureus caused 193 of 949 cases of endocarditis (20%), 71 (7.3%) in persons who injected drugs. Periodic surveillance and cross-sectional follow-up achieved 85% of possible follow-up time. The primary end point was allograft infection in patients with nonendocarditis and endocarditis indications. Risk factors were identified by hazard function decomposition and machine learning.

Results: During follow-up, 30 allografts (26 explanted) became infected in patients in the nonendocarditis group and 49 (41 explanted) in patients with endocarditis. At 20 years, the probability of allograft infection was 5.6% in patients in the nonendocarditis group and 14% in patients with endocarditis. Risk factors for allograft infection in patients in the nonendocarditis group were younger patient age and older donor age. Risk factors for allograft infection in patients with endocarditis were earlier implant year, injection drug use, and younger age. In patients with endocarditis, 18% of allograft infections were caused by the original organism.

Conclusions: The low infection rates, both in patients without and with endocarditis, support continued use of allografts in the modern era, in particular for the treatment of invasive endocarditis of the aortic root.
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http://dx.doi.org/10.1016/j.jtcvs.2021.04.086DOI Listing
May 2021

Health-Related Quality of Life After Extensive Aortic Replacement.

Semin Thorac Cardiovasc Surg 2021 Jul 13. Epub 2021 Jul 13.

Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio. Electronic address:

To assess and compare patient-reported long-term health-related quality of life (HRQoL) after combined proximal aortic (arch ± ascending, root) and distal aortic (descending thoracic ± abdominal) replacement using open vs multimodal/endovascular (hybrid) approaches. From 2010 to 2016, 146 adults underwent single- or multi-stage aortic arch plus descending thoracic aorta replacement, 31 open and 115 hybrid. The 2 surgical approach groups had similar preoperative characteristics and extent of surgery. Cross-sectional follow-up revealed 49 deaths (7 open, 42 hybrid). Of the 97 survivors, 72 (74%) responded to the Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 survey (18 open, 54 hybrid) a median 6.2 years (15th, 85th percentiles: 3.1, 7.9) after their last aortic surgery. Predictors of HRQoL scores were identified by random forest regression. Overall physical HRQoL T-score was lower than that of population norms (46 vs 50, P < 0.0001); mental HRQoL T-score was similar (50 vs 50, P > 0.9). Neither T-score was significantly different according to surgical approach (P ≥ 0.3). Greater number of postoperative complications and history of chronic obstructive pulmonary disease were the most important predictors of lower physical HRQoL, and prior myocardial infarction was the most important predictor of lower mental HRQoL. Although extensive aortic replacement had a small long-term effect on patient-reported physical HRQoL, both physical and mental HRQoL can be preserved in survivors with both surgical approaches. Surgeons should recommend the approach they believe will yield the best long-term survival, but lifelong follow-up is crucial, and patients should understand that they may require multiple operations.
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http://dx.doi.org/10.1053/j.semtcvs.2021.07.006DOI Listing
July 2021

Introduction to Expert Opinions on appropriate use of databases in cardiothoracic research: Pounding nails with a screwdriver.

J Thorac Cardiovasc Surg 2021 Oct 8;162(4):1143-1145. Epub 2021 Jun 8.

Sydell and Arnold Miller Family Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

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http://dx.doi.org/10.1016/j.jtcvs.2021.05.042DOI Listing
October 2021

Time-related risk of pulmonary conduit re-replacement: a Congenital Heart Surgeons' Society Study.

Ann Thorac Surg 2021 Jun 4. Epub 2021 Jun 4.

Division of Pediatric Cardiology, The Hospital for Sick Children, 555 University Ave., Toronto, ON M5G 1X8, Canada. Electronic address:

Background: Patients receiving a right ventricle-to-pulmonary artery conduit in infancy will require successive procedures or replacements, each with variable longevity. We sought to identify factors associated with time-related risk of a subsequent surgical replacement (PC3) or transcatheter pulmonary valve insertion (TPVI) after a second surgically-placed PC (PC2).

Methods: From 2002 to 2016, 630 patients from 29 Congenital Heart Surgeons' Society member institutions survived to discharge after initial valved PC insertion (PC1) at age < 2 years. Of those, 355 had undergone surgical replacement (PC2) of that initial conduit. Competing risk methodology and multiphase parametric hazard analyses were used to identify factors associated with time-related risk of PC3 or TPVI.

Results: Of 355 PC2 patients (median follow-up of 5.3 years), 65 underwent PC3 and 41 TPVI. Factors at PC2 associated with increased time-related risk of PC3 were smaller PC2 Z score (Hazard Ratio [HR] 1.6, p<0.001), concomitant aortic valve intervention (HR 7.6, p=0.009), aortic allograft (HR 2.2, p=0.008), younger age (HR 1.4, p<0.001), and larger Z score of PC1 (HR 1.2, p=0.04). Factors at PC2 associated with increased time-related risk of TPVI were aortic allograft (HR: 3.3, p=0.006), porcine unstented conduit (HR 4.7, p<0.001), and older age (HR 2.3, p=0.01).

Conclusions: Aortic allograft as PC2 was associated with increased time-related risk of both PC3 and TPVI. Surgeons may reduce risk of these subsequent procedures by not selecting an aortic homograft at PC2, and by oversizing the conduit when anatomically feasible.
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http://dx.doi.org/10.1016/j.athoracsur.2021.05.024DOI Listing
June 2021

Value of psychosocial evaluation for left ventricular assist device candidates.

J Thorac Cardiovasc Surg 2021 Apr 29. Epub 2021 Apr 29.

Cleveland Clinic Heart and Vascular Institute, Cleveland, Ohio; Cleveland Clinic Lerner College of Medicine of Case Western Reserve University School of Medicine, Cleveland, Ohio. Electronic address:

Objective: Left ventricular assist devices require a psychosocial assessment to determine candidacy despite limited data correlating with outcome. Our objective is to determine whether the Stanford Integrated Psychosocial Assessment for Transplant, a tool validated for transplant and widely used by left ventricular assist device programs, predicts left ventricular assist device program hospital readmissions and death.

Methods: We performed a retrospective analysis of adults at the Cleveland Clinic with Stanford Integrated Psychosocial Assessment for Transplant scores before primary left ventricular assist device program implantation from April 1, 2013, to December 31, 2018. The primary outcome was unplanned hospital readmissions censored at death, transplantation, and transfer of care. The secondary outcome was death.

Results: There were 263 patients in the left ventricular assist device program with a median (Q1, Q3) Stanford Integrated Psychosocial Assessment for Transplant score of 16 (8, 28). During a median follow-up 1.2 years, 56 died, 65 underwent transplantation, and 21 had transferred care. There were 640 unplanned hospital readmissions among 250 patients with at least 1 outpatient visit at our center. In a multivariable analysis, Stanford Integrated Psychosocial Assessment for Transplant components but not total Stanford Integrated Psychosocial Assessment for Transplant score was associated with readmissions. Psychopathology (Stanford Integrated Psychosocial Assessment for Transplant C-IX) was associated with hemocompatibility (coefficient 0.21 ± standard error 0.11, P = .040) and cardiac (0.15 ± 0.065, P = .02) readmissions. Patient readiness was associated with noncardiac (Stanford Integrated Psychosocial Assessment for Transplant A-III, 0.24 ± 0.099, P = .016) and cardiac (Stanford Integrated Psychosocial Assessment for Transplant A-low total, 0.037 ± 0.014, P = .007) readmissions. Poor living environment (Stanford Integrated Psychosocial Assessment for Transplant B-VIII) was associated with device-related readmissions (0.83 ± 0.34, P = .014). Death was associated with organic psychopathology or neurocognitive impairment (Stanford Integrated Psychosocial Assessment for Transplant C-X, 0.59 ± 0.21, P = .006).

Conclusions: Total Stanford Integrated Psychosocial Assessment for Transplant score was not associated with left ventricular assist device program readmission or mortality. However, we identified certain Stanford Integrated Psychosocial Assessment for Transplant components that were associated with outcome and could be used to create a left ventricular assist device program specific psychosocial tool.
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http://dx.doi.org/10.1016/j.jtcvs.2021.04.065DOI Listing
April 2021

Outcomes of Open v. Endovascular Repair of Descending Thoracic and Thoracoabdominal Aortic Aneurysms.

Ann Thorac Surg 2021 May 25. Epub 2021 May 25.

Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio.

Background: Open repair is the standard of care for patients with descending thoracic and thoracoabdominal aortic aneurysms. Although effective, surgery carries a high risk of morbidity and mortality. Endovascular stent-grafts were introduced to treat these aneurysms in patients considered too high risk for open repair. Early results are promising, but later results are incompletely known. Therefore, we sought to compare short- and intermediate-term outcomes of open versus endovascular repair for these aneurysms.

Methods: From 2000-2010, 1,053 patients underwent open (n=457) or endovascular (n=596) repair of descending thoracic and thoracoabdominal aortic aneurysms at Cleveland Clinic. To balance patient characteristics between these groups, propensity-score matching was performed, yielding 278 well-matched pairs (61% of possible pairs). Endpoints included short- and long-term outcomes.

Results: In matched patients, compared with endovascular stenting, open repair achieved similar in-hospital mortality (n=23/8.3% vs n=21/7.6%, P=.8) and occurrence of paralysis and stroke (n=10/3.6% vs n=6/2.2%, P=.3), despite longer postoperative stay (median 11 vs 6 days), more dialysis-dependent acute renal failure (n=24/8.6% vs n=9/3.3%, P=.008), and prolonged ventilation (n=106/46% vs n=17/6.3%, P<.0001). Open repair resulted in better 10-year survival than endovascular repair (52% vs 33%, P<.0001), and aortic reintervention was less frequent (4% vs 21%, P<.0001). Despite a decrease in the first postoperative year, average aneurysm size did not recover to normal range after endovascular stenting.

Conclusions: Open repair of descending thoracic and thoracoabdominal aneurysms can achieve acceptable short-term outcomes with better intermediate-term outcomes than endovascular repair.
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http://dx.doi.org/10.1016/j.athoracsur.2021.04.100DOI Listing
May 2021

Pleural space management after lung transplant: Early and late outcomes of pleural decortication.

J Heart Lung Transplant 2021 Jul 29;40(7):623-630. Epub 2021 Mar 29.

Department of Thoracic and Cardiovascular Surgery, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio; Lung Transplant Program, Transplant Institute, Cleveland Clinic, Cleveland, Ohio; Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Background: Pleural complications after lung transplant may restrict allograft expansion, requiring decortication. However, its extent, indications, risk factors, and effect on allograft function and survival are unclear.

Methods: From January 2006 to January 2017, 1,039 patients underwent primary lung transplant and 468 had pleural complications, 77 (16%) of whom underwent 84 surgical decortications for pleural space management. Multivariable time-related analysis was performed to identify risk factors for decortication. Mixed-effect longitudinal modeling was used to assess allograft function before and after decortication.

Results: Cumulative number of decortications per 100 transplants was 1.8, 7.8, and 8.8 at 1 month, 1 year, and 3 years after transplant, respectively. Indications for the 84 decortications were complex effusion in 47 (56%), fibrothorax in 17 (20%), empyema in 11 (13%), and hemothorax in 9 (11%). Thoracoscopic operations were performed in 52 (62%) and full lung re-expansion was achieved in 76 (90%). Complications occurred after 30 (36%) decortications, with 15 pulmonary complications (18%), including 2 patients requiring extracorporeal support due to worsening function. Ten reinterventions occurred via thoracentesis (2), tube thoracostomy (1), and reoperation (7). In-hospital and 30-day mortality was 5.2% (n = 4/77). Forced expiratory volume in 1 second increased from 50% to 60% within the first year after decortication, followed by a slow decline to 55% at 5 years. Postdecortication survival was 87%, 68%, and 48% at 1, 3, and 5 years, respectively.

Conclusions: Despite high risk of reoperative surgery, decortication after lung transplant allows salvage of pleural space and graft function with a reasonable morbidity profile.
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http://dx.doi.org/10.1016/j.healun.2021.03.021DOI Listing
July 2021

Similar long-term survival after isolated bioprosthetic versus mechanical aortic valve replacement: A propensity-matched analysis.

J Thorac Cardiovasc Surg 2021 Jan 20. Epub 2021 Jan 20.

Department of Thoracic and Cardiovascular Surgery, Heart, Vascular, and Thoracic Institute, Cleveland, Ohio. Electronic address:

Objectives: Improved durability and preference to avoid anticoagulation have led to increasing use of bioprostheses in younger patients despite the need for eventual reoperation. Therefore, we compared in-hospital complications, reoperation, and survival after bioprosthetic and mechanical aortic valve replacement.

Methods: From January 1990 to January 2020, 6143 patients underwent isolated aortic valve replacement at Cleveland Clinic; 637 patients received a mechanical prosthesis and 5506 a bioprosthesis. Propensity matching identified 527 well-matched pairs (83% of possible matches) for comparison of perioperative outcomes. The average age of patients was 54 years in the bioprosthesis group and 55 years in the mechanical prosthesis group. Random Forest machine-learning analysis was performed to compare survival using the entire cohort of 6143 patients.

Results: Among matched patients, major in-hospital complications, including stroke, deep sternal wound infection, and reoperation for bleeding, were similar, as was in-hospital mortality (2 in the bioprosthesis group [0.38%] vs 3 in the mechanical prosthesis group [0.57%]; P > .9). Patients receiving a bioprosthesis had shorter hospital stays (median 6 vs 7 days, P < .0001). Fifty-one patients (32% at 14 years) in the bioprosthesis group and 17 patients in the mechanical prosthesis group (8% at 14 years) underwent reoperation (P [log-rank] < .0001); 5-year survival after reoperation was 85% versus 82% (P = .6). Risk-adjusted Random Forest prediction of 18-year survival was 60% in the bioprosthetic group and 58% in the mechanical prosthesis group.

Conclusions: Aortic valve bioprostheses are associated with excellent short-term outcomes and 18-year survival similar to that of patients receiving mechanical valves. Reoperation does not adversely affect survival. These results suggest that risk for reoperation alone should not deter the use of bioprostheses in younger patients.
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http://dx.doi.org/10.1016/j.jtcvs.2020.11.181DOI Listing
January 2021

Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research.

J Am Coll Cardiol 2021 Jun 19;77(21):2717-2746. Epub 2021 Apr 19.

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

Aims: The Valve Academic Research Consortium (VARC), founded in 2010, was intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. Rapid evolution of the field, including the emergence of new complications, expanding clinical indications, and novel therapy strategies have mandated further refinement and expansion of these definitions to ensure clinical relevance. This document provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.

Methods And Results: Several years after the publication of the VARC-2 manuscript, an in-person meeting was held involving over 50 independent clinical experts representing several professional societies, academic research organizations, the US Food and Drug Administration (FDA), and industry representatives to (i) evaluate utilization of VARC endpoint definitions in clinical research, (ii) discuss the scope of this focused update, and (iii) review and revise specific clinical endpoint definitions. A writing committee of independent experts was convened and subsequently met to further address outstanding issues. There were ongoing discussions with FDA and many experts to develop a new classification schema for bioprosthetic valve dysfunction and failure. Overall, this multi-disciplinary process has resulted in important recommendations for data reporting, clinical research methods, and updated endpoint definitions. New definitions or modifications of existing definitions are being proposed for repeat hospitalizations, access site-related complications, bleeding events, conduction disturbances, cardiac structural complications, and bioprosthetic valve dysfunction and failure (including valve leaflet thickening and thrombosis). A more granular 5-class grading scheme for paravalvular regurgitation (PVR) is being proposed to help refine the assessment of PVR. Finally, more specific recommendations on quality-of-life assessments have been included, which have been targeted to specific clinical study designs.

Conclusions: Acknowledging the dynamic and evolving nature of less-invasive aortic valve therapies, further refinements of clinical research processes are required. The adoption of these updated and newly proposed VARC-3 endpoints and definitions will ensure homogenous event reporting, accurate adjudication, and appropriate comparisons of clinical research studies involving devices and new therapeutic strategies.
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http://dx.doi.org/10.1016/j.jacc.2021.02.038DOI Listing
June 2021

Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research.

Eur Heart J 2021 05;42(19):1825-1857

Columbia University Irving Medical Center/NewYork-Presbyterian Hospital and Cardiovascular Research Foundation, New York, NY, USA.

Aims: The Valve Academic Research Consortium (VARC), founded in 2010, was intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. Rapid evolution of the field, including the emergence of new complications, expanding clinical indications, and novel therapy strategies have mandated further refinement and expansion of these definitions to ensure clinical relevance. This document provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.

Methods And Results: Several years after the publication of the VARC-2 manuscript, an in-person meeting was held involving over 50 independent clinical experts representing several professional societies, academic research organizations, the US Food and Drug Administration (FDA), and industry representatives to (i) evaluate utilization of VARC endpoint definitions in clinical research, (ii) discuss the scope of this focused update, and (iii) review and revise specific clinical endpoint definitions. A writing committee of independent experts was convened and subsequently met to further address outstanding issues. There were ongoing discussions with FDA and many experts to develop a new classification schema for bioprosthetic valve dysfunction and failure. Overall, this multi-disciplinary process has resulted in important recommendations for data reporting, clinical research methods, and updated endpoint definitions. New definitions or modifications of existing definitions are being proposed for repeat hospitalizations, access site-related complications, bleeding events, conduction disturbances, cardiac structural complications, and bioprosthetic valve dysfunction and failure (including valve leaflet thickening and thrombosis). A more granular 5-class grading scheme for paravalvular regurgitation (PVR) is being proposed to help refine the assessment of PVR. Finally, more specific recommendations on quality-of-life assessments have been included, which have been targeted to specific clinical study designs.

Conclusions: Acknowledging the dynamic and evolving nature of less-invasive aortic valve therapies, further refinements of clinical research processes are required. The adoption of these updated and newly proposed VARC-3 endpoints and definitions will ensure homogenous event reporting, accurate adjudication, and appropriate comparisons of clinical research studies involving devices and new therapeutic strategies.
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http://dx.doi.org/10.1093/eurheartj/ehaa799DOI Listing
May 2021

Invasive Aortic Valve Endocarditis: Clinical and Tissue Findings from a Prospective Investigation.

Ann Thorac Surg 2021 Apr 8. Epub 2021 Apr 8.

Department of Thoracic and Cardiovascular Surgery, Pathology and Laboratory Medicine Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Background: Advanced aortic valve infective endocarditis (IE) with progression and destruction beyond the valve cusps-invasive IE-is incompletely characterized. We aimed to further characterize invasive disease extent, location, and stage and correlate macroscopic operative findings with microscopic disease patterns and progression.

Methods: Forty-three patients with invasive aortic valve IE were prospectively enrolled from 8/2017 to 7/2018. Twenty-three (53%) had prosthetic valve, 2 (5%) allograft, and 18 (42%) native aortic valve IE. Surgical findings and intraoperative photography were analyzed for invasion location, extent, and stage. Surgical samples were formalin-fixed and analyzed histologically. Time course of disease and management was evaluated.

Results: Pathogens included Staphylococcus aureus in 17 (40%). Invasion predominantly affected the non-left commissure (76%) and was circumferential in 15 (35%; 14 were prosthetic valves). Extra-aortic cellulitis was present in 29 (67%), abscess in 13 (30%), abscess cavity in 29 (67%), and pseudoaneurysm in 8 (19%); 7 (16%) had fistulae. Histopathology revealed acute inflammation, abscess formation, and lysis of connective tissue, but not myocardium or elastic tissue. Median time from onset of symptoms to antibiotics was 5 days, invasion confirmation 15 days, and surgery 37 days. S. aureus cases had a 21-day shorter time course than non-S. aureus cases. Eight patients developed new/worsening heart block.

Conclusions: Advanced invasive aortic valve IE demonstrates consistent gross patterns and stages correlating with histopathologic findings. Invasion results from a confluence of factors, pathogen, time, host immune response and other and primarily affects the fibrous skeleton of the heart and expands to low-pressure regions.
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http://dx.doi.org/10.1016/j.athoracsur.2021.03.072DOI Listing
April 2021

Modern practice and outcomes of reoperative cardiac surgery.

J Thorac Cardiovasc Surg 2021 Jan 23. Epub 2021 Jan 23.

Department of Thoracic and Cardiovascular Surgery, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio.

Objectives: To evaluate recent practice and outcomes of reoperative cardiac surgery via re-sternotomy. Use of early versus late institution of cardiopulmonary bypass (CPB) before sternal re-entry was of particular interest.

Methods: From January 2008 to July 2017, 7640 patients underwent reoperative cardiac surgery at Cleveland Clinic. The study group consisted of 6627 who had a re-sternotomy and preoperative computed tomography scans; 755 and 5872 were in the early and late institution of CPB groups, respectively. Patients were stratified into high (n = 563) or low (n = 6064) anatomic risk of re-entry on the basis of computed tomography criteria. Weighted propensity-balanced operative mortality and morbidity were compared with surgeon as a random effect.

Results: Reoperative procedures most commonly incorporated aortic valve replacement (n = 3611) and coronary artery bypass grafting (n = 2029), but also aortic root (n = 1061) and arch procedures (n = 527). Unadjusted operative mortality was 3.5% (235/6627), and major sternal re-entry and mediastinal dissection injuries were uncommon (2.8%). In the propensity-weighted analysis, similar mortality (3.1% vs 4.5%; P = .6) and major morbidity, including stroke (1.8% vs 3.2%) and dialysis (0 vs 2.6%), were noted in the high anatomic risk cohort between early and late CPB groups. Similar trends were observed in the low anatomic risk cohort (mortality 3.5% vs 2.1%; P = .2).

Conclusions: Reoperative cardiac surgery is associated with low operative morbidity and mortality at an experienced center. Early and late CPB strategies have comparable outcomes in the context of an image-guided, team-based strategy.
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http://dx.doi.org/10.1016/j.jtcvs.2021.01.028DOI Listing
January 2021

Evolution of Alternative-access Transcatheter Aortic Valve Replacement.

Ann Thorac Surg 2021 Feb 27. Epub 2021 Feb 27.

Department of Thoracic and Cardiovascular Surgery, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Background: Transfemoral access is the most common approach for transcatheter aortic valve replacement (TAVR). However, a subset of patients require alternative access. This study describes the evolution and outcomes of alternative-access TAVR at Cleveland Clinic.

Methods: From January 2006 to January 2019, 2446 patients underwent TAVR, 414 (17%) through alternative access (247 transapical, 95 transaortic, 56 transaxillary, 2 transcarotid, 10 transiliac, 4 transcaval). Patients undergoing alternative-access TAVR had high preoperative risk. Propensity-matched comparisons were targeted at comparing transfemoral versus transaxillary approaches since 2012.

Results: Over time, the favored alternative-access approach shifted from transapical and transaortic to transaxillary. Pacemaker requirement was similar for alternative-access and transfemoral approaches. Compared with transfemoral access, major vascular injuries were higher in the alternative-access group (12 [2.9%] vs 27 [1.3%], P = .02), but minor vascular injuries were lower (13 [3.1%] vs 198 [9.8%], P < .0001). Non-risk-adjusted 5-year survival was lower in the alternative-access group (45% vs 59%). Compared with intrathoracic approaches (transapical and transaortic), transaxillary access was associated with fewer blood transfusions (12 [21%] vs 176 [51%], P < .0001), less prolonged ventilation (1 [1.8%] vs 38 [11%], P = .03), and shorter length of stay (median, 5 vs 7.5 days, P < .0001). Survival and major morbidity were similar in matched comparisons of the transfemoral and transaxillary approaches. No brachial plexus injuries occurred with transaxillary access.

Conclusions: The transaxillary approach has emerged as our preferred alternative-access strategy for TAVR. It is associated with superior operative outcomes compared with transthoracic approaches, and results are comparable with those of the transfemoral approach.
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http://dx.doi.org/10.1016/j.athoracsur.2021.02.018DOI Listing
February 2021

Repair, Reconstruct, or Divert: Fate of the Perforated Esophagus.

Ann Surg 2021 Jan 15. Epub 2021 Jan 15.

*Heart and Vascular Institute, Department of Thoracic and Cardiovascular Surgery, Cleveland, OH †Research Institute, Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH.

Objectives: The aim of this study was to determine differences in esophageal perforation populations undergoing different advanced interventions for perforated esophagus and identify predictors of treatment outcomes.

Summary Background Data: Contained esophageal perforation can often be managed expectantly, but uncontained perforation is uniformly fatal without invasive intervention. Treatment options for the latter range from simple endoscopic control through advanced intervention. Clinical presentation varies greatly and directs which intervention is most appropriate.

Methods: From 1996 to 2017, 335 patients were treated for esophageal perforation, and 166 for advanced interventions: 74 primary repair with tissue flap (repair), 26 esophagectomy and gastric pull-up (resection), and 66 esophagectomy and immediate diversion with planned delayed reconstruction (resection-diversion). Patient characteristics, clinical presentation, operative outcomes, and survival were abstracted. Pittsburgh Severity Scores (PSS) were retrospectively calculated. Random survival forest analysis was performed for 90-day mortality and competing risks for reconstruction after resection-diversion.

Results: Repair and resection patients had lower PSS than resection-diversion patients (3 vs 3 vs 6, respectively). Ninety-day mortality for repair, resection, and resection-diversion was 11% vs 7.7% vs 23%, and 5-year survival was 71% vs 63% vs 47%. Risk of death after resection-diversion was highest within 1 year, but 52% of patients had reconstruction of the upper alimentary tract within 2 years.

Conclusions: Several advanced interventions exist for critically ill patients with uncontained esophageal perforation. Repair and organ preservation are always preferred; however, patients at extremes of illness might best be treated with resection-diversion, with the understanding that the competing risk of death may preclude eventual reconstruction.
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http://dx.doi.org/10.1097/SLA.0000000000003648DOI Listing
January 2021

To P or not to P, that is the question: Four expert opinions on the P value controversy.

J Thorac Cardiovasc Surg 2021 04 28;161(4):1365-1366. Epub 2020 Dec 28.

Sydell and Arnold Miller Family Heart, Vascular, and Thoracic Institute and Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland Clinic, Cleveland, Ohio. Electronic address:

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http://dx.doi.org/10.1016/j.jtcvs.2020.12.091DOI Listing
April 2021

Looking beyond the eyeball test: A novel vitality index to predict recovery after esophagectomy.

J Thorac Cardiovasc Surg 2021 03 13;161(3):822-832.e6. Epub 2020 Nov 13.

Department of Thoracic and Cardiovascular Surgery, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Objectives: To (1) measure 4 physiologic metrics before esophagectomy, (2) use these in an index to predict composite postoperative outcome after esophagectomy, and (3) compare predictive accuracy of this index to that of the Fried Frailty Index and Modified Frailty Index.

Methods: Grip strength (kilograms), 30-second chair sit-stands (number), 6-minute walk distance (meters), and normalized psoas muscle area (cm/m) were measured for 77 consenting patients from January 1, 2018, to April 1, 2019. Imbalanced random forest classification estimated probability of a composite postoperative outcome, which included mortality, respiratory complications, anastomotic leak, delirium, length of stay ≥14 days, discharge to nursing facility, and readmission. G-mean error was used to compare predictive accuracy among indexes.

Results: Median grip strength was 38 kg (25th-75th percentiles, 31-44), number of sit-stands 11 (10-14), psoas muscle area to height ratio 6.9 cm/m (6.0-8.2), and 6-minute walk distance 407 m (368-451). There was generally weak correlation between these metrics, with the highest between 30-second sit-stands and 6-minute walk distance (r = 0.57). Age, degree of patient-reported exhaustion, and the 4 objective metrics comprised the Esophageal Vitality Index, which had a lower G-mean error of 32% (31-33) than the Fried Frailty Index, 37% (37-38), and the Modified Frailty Index, 48% (47-48).

Conclusions: The Esophageal Vitality Index, an objective, simple assessment consisting of grip strength, 30-second chair sit-stands, 6-minute walk, and psoas muscle area to height ratio outperformed commonly used frailty indexes in predicting postesophagectomy mortality and morbidity. The index provides a robust picture of patients' fitness for surgery beyond the qualitative "eyeball" test.
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http://dx.doi.org/10.1016/j.jtcvs.2020.10.122DOI Listing
March 2021

A conservative screening algorithm to determine candidacy for robotic mitral valve surgery.

J Thorac Cardiovasc Surg 2020 Dec 17. Epub 2020 Dec 17.

Department of Thoracic and Cardiovascular Surgery, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Objective: Patient selection for robotically assisted mitral valve repair remains controversial. We assessed outcomes of a conservative screening algorithm developed to select patients with degenerative mitral valve disease for robotic surgery.

Methods: From January 2014 to January 2019, a screening algorithm that included transthoracic echocardiography and computed tomography scanning was rigorously applied by 3 surgeons to assess candidacy of 1000 consecutive patients with isolated degenerative mitral valve disease (age 58 ± 11 years, 67% male) for robotic surgery. Screening results and hospital outcomes of those selected for robotic versus sternotomy approaches were compared.

Results: With application of the screening algorithm, 605 patients were selected for robotic surgery. Common reasons for sternotomy (n = 395) were aortoiliac atherosclerosis (n = 74/292, 25%), femoral artery diameter <7 mm (n = 60/292, 20%), mitral annular calcification (n = 83/390, 21%), aortic regurgitation (n = 100/391, 26%), and reduced left ventricular function (n = 126/391, 32%). Mitral valve repair was accomplished in 996. Compared with sternotomy, patients undergoing robotic surgery had less new-onset atrial fibrillation (n = 144/582, 25% vs n = 125/373, 34%; P = .002), fewer red blood cell transfusions (n = 61/601, 10% vs 69/395, 17%; P < .001), and shorter hospital stay (5.2 ± 2.9 days vs 5.9 ± 2.1 days; P < .001). No hospital deaths occurred, and occurrence of postoperative stroke in the robotic (n = 3/605, 0.50%) and sternotomy (n = 4/395, 1.0%; P = .3) groups was similar.

Conclusions: This conservative screening algorithm qualified 60% of patients with isolated degenerative mitral valve disease for robotic surgery. Outcomes were comparable with those obtained with sternotomy, validating this as an approach to select patients for robotic mitral valve surgery.
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December 2020

Commentary: Tell me a story.

J Thorac Cardiovasc Surg 2020 Nov 7. Epub 2020 Nov 7.

Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

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http://dx.doi.org/10.1016/j.jtcvs.2020.11.011DOI Listing
November 2020

Anomalous Aortic Origin of a Coronary Artery in Adults.

Ann Thorac Surg 2020 Dec 4. Epub 2020 Dec 4.

Department of Pediatric Cardiology, St. Luke's Health System, Boise, Idaho. Electronic address:

Background: Anomalous aortic origin of a coronary artery (AAOCA) is the second leading cause of sudden death in youth. However, its significance and optimal management in adults is poorly understood. Our objective is to characterize AAOCA in a large single-center adult cohort based on coronary anatomic variants and surgical management strategies.

Methods: We reviewed imaging, clinic, and operative reports for 645 adults with an encounter diagnosis code of congenital coronary anomaly from July 2015 to July 2017. After excluding other congenital heart defects, we characterized 167 patients with AAOCAs by anatomic variant, symptoms at diagnosis, indication for advanced imaging, and if performed, surgical repair. To describe the anatomic variant, we classified the origin and course by following the atomization scheme developed by the Congenital Heart Surgeon's Society's AAOCA registry.

Results: Among adults with AAOCA, the anomalous origin involved the right coronary artery in 57% (96 of 167), left main coronary artery in 23% (39 of 167), left anterior descending in 2% (4 of 167), circumflex in 16% (26 of 167), and multiple coronaries in 1% (2 of 167). Anomalous right coronary arteries were diagnosed at an older median age than anomalous left main coronary arteries (55 vs 51 years, respectively; P = .026). Surgical repair of AAOCA occurred in 22% (36 of 167) of patients. Concomitant cardiac surgical procedures accompanied 36% (13 of 36) of them. No deaths occurred over a median follow-up of 2.5 years.

Conclusions: Most patients in our single-center AAOCA registry were diagnosed in the presence of cardiac symptoms. Concomitant aortic valve disease and coronary atherosclerotic burden complicate both the evaluation and surgical approach to adult AAOCA repair.
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http://dx.doi.org/10.1016/j.athoracsur.2020.06.153DOI Listing
December 2020

Response to Comments on "Value of Lymphadenectomy in Patients Receiving Neoadjuvant Therapy for Esophageal Adenocarcinoma".

Ann Surg 2020 Dec 3. Epub 2020 Dec 3.

Heart and Vascular Institute Department of Thoracic and Cardiovascular Surgery Cleveland Clinic, Cleveland, Ohio Heart and Vascular Institute Department of Thoracic and Cardiovascular Surgery Cleveland Clinic, Cleveland, Ohio Research Institute Department of Quantitative Health Sciences Cleveland Clinic, Cleveland, Ohio.

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http://dx.doi.org/10.1097/SLA.0000000000004272DOI Listing
December 2020

Adjunctive endovascular balloon fracture fenestration for chronic aortic dissection.

J Thorac Cardiovasc Surg 2020 Oct 7. Epub 2020 Oct 7.

Department of Thoracic and Cardiovascular Surgery, Heart Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio; Aortic Center, Heart Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio;. Electronic address:

Objective: Positive remodeling after thoracic endovascular aortic repair (TEVAR) for chronic thoracic aortic dissection is variable due to incomplete distal seal and retrograde false lumen perfusion. We assessed the outcomes of adjunctive balloon fracture fenestration (BFF) during TEVAR in patients with chronic aortic dissection complicated by negative remodeling.

Methods: From June 2013 to January 2016, 49 patients with chronic aortic dissection complicated by aneurysm due to negative remodeling underwent TEVAR with BFF. Contrast-enhanced computed tomography was performed before discharge, at 3 to 6 months, and annually.

Results: Intraoperatively, endovascular stent graft expansion was achieved in all patients. There was 1 hospital death due to visceral malperfusion related to acute-on-chronic dissection noted before planned BFF. There were no occurrences of paraplegia, 3 patients had stroke, and 3 had acute renal failure. Survival at 1 year was 91%. Late reintervention for incomplete false lumen exclusion was required in 16 patients and freedom from reintervention was 75% at 1 year. Thirty-six patients (73.5%) had complete false lumen thrombosis through the treated segment. True lumen area increased following TEVAR with BFF and continued to incrementally expand with subsequent aortic remodeling at 1-year follow-up. Thirteen patients had positive remodeling, defined as thrombosis of false lumen, ≥10% decrease in aortic dimension, and ≥10% increase in true lumen diameter. Patients with positive remodeling had an average decrease of 11 mm in maximal aortic diameter at final follow-up.

Conclusions: BFF of chronic dissection membrane is a beneficial adjunct to TEVAR during short-term follow-up and may promote positive aortic remodeling and is worthy of further study.
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http://dx.doi.org/10.1016/j.jtcvs.2020.09.106DOI Listing
October 2020

Right versus left heart reverse remodelling after treating ischaemic mitral and tricuspid regurgitation.

Eur J Cardiothorac Surg 2020 Nov 14. Epub 2020 Nov 14.

Department of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH, USA.

Objectives: Repair outcomes of tricuspid regurgitation (TR) associated with ischaemic mitral regurgitation (IMR) are inferior to functional TR in terms of TR recurrence and right ventricular (RV) reverse remodelling. Our objective is to analyse right versus left heart reverse remodelling after surgery for IMR-associated TR.

Methods: From 2001 to 2011, 568 patients with severe IMR underwent mitral valve surgery (repair 87%, replacement 13%), and 131 had concomitant tricuspid valve repair. Median follow-up was 3.0 years; 25% of living patients were followed up for 6.3 years. Longitudinal analysis of 1527 follow-up echocardiograms was performed to assess ventricular reverse remodelling and function.

Results: Unlike the left heart, the right heart failed to reverse remodel (failed to recover ventricular function or halt dilatation). During follow-up after surgery, the right ventricle continued to dilate while the left ventricle regressed in size. RV ejection fraction decreased (46% at 1 month and 44% at 5 years), while left ventricular ejection fraction increased (33% and 37%, respectively). RV strain showed early (-11% at 1 month) and late (-12% at 5 years) dysfunction. Patients who underwent tricuspid valve repair had worse RV function. Mitral regurgitation remained stable after surgical intervention, and TR gradually recurred (37% moderate, 20% severe at 7 years).

Conclusions: Surgical treatment of IMR and TR along with revascularization failed to induce reverse remodelling of the right heart. These findings warrant further investigations to identify optimal timing and approach of intervention for IMR-associated TR with respect to RV remodelling.
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http://dx.doi.org/10.1093/ejcts/ezaa326DOI Listing
November 2020

Outcomes of mitral valve re-replacement for bioprosthetic structural valve deterioration.

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

Department of Thoracic and Cardiovascular Surgery, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Objectives: Reoperation for structural valve deterioration (SVD) of bioprosthetic mitral valves carries a presumed high operative risk, and transcatheter mitral valve-in-valve implantation has emerged as an alternative. However, surgical risk and long-term outcome following mitral valve re-replacement in these patients remain ill-defined. Hence, we sought to evaluate outcomes and long-term survival following surgical mitral valve re-replacement and to identify risk factors for mortality.

Methods: From January 1990 to January 2017, 525 patients underwent surgical mitral valve re-replacement at Cleveland Clinic for bioprosthetic SVD: 133 (25%) isolated operations and 392 (75%) with concomitant procedures. Surgical complications and modes of death were compiled, long-term mortality assessed, and risk factors identified using a multivariable nonproportional hazards model and random forest analysis.

Results: SVD was characterized by bioprosthetic regurgitation in 81% (425 out of 525) and stenosis in 44% (231 out of 525). One in-hospital death occurred after isolated valve re-replacement (0.75%) and 28 deaths occurred (7.1%; P = .003) after nonisolated re-replacement, 19 (68%) of which were from coagulopathy, vasoplegia, and multisystem organ failure. In the nonisolated group, incremental risk factors for time-related death after re-replacement included New York Heart Association functional class IV symptoms, concomitant coronary artery bypass grafting, prolonged cardiopulmonary bypass time, and transfusions.

Conclusions: Mitral valve re-replacement for bioprosthetic SVD was associated with low surgical risk and excellent long-term survival. Isolated mitral valve re-replacement for bioprosthetic SVD had near-zero surgical risk. Excessive cardiopulmonary bypass duration and multiple transfusions correlated with increased early mortality in nonisolated procedures, as did preoperative severe heart failure. Optimal surgical plan and timing of surgery are keys to success.
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http://dx.doi.org/10.1016/j.jtcvs.2020.08.067DOI Listing
August 2020

Commentary: Dabblers: Beware of hidden dangers in machine-learning comparisons.

J Thorac Cardiovasc Surg 2020 Aug 31. Epub 2020 Aug 31.

Department of Quantitative Health Sciences, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

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http://dx.doi.org/10.1016/j.jtcvs.2020.08.091DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7914303PMC
August 2020

Durability and Performance of 2298 Trifecta Aortic Valve Prostheses: A Propensity-Matched Analysis.

Ann Thorac Surg 2021 04 1;111(4):1198-1205. Epub 2020 Oct 1.

Department of Thoracic and Cardiovascular Surgery, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio; Aorta Center, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Background: Reports of early failure of the Trifecta externally wrapped, bovine pericardial aortic valve prosthesis (Abbott Laboratories, Abbott Park, IL) raise concerns about its durability. This study evaluated the hemodynamic performance and explant of Trifecta valves compared with the PERIMOUNT bovine pericardial prosthesis (Edwards Lifesciences, Irvine, CA).

Methods: From October 2007 to July 2017, 2305 patients received a Trifecta bioprosthesis during aortic valve replacement at Cleveland Clinic. Trends in postoperative valve hemodynamics were assessed from 4971 transthoracic echocardiograms and valve explants by systemic follow-up. To compare outcomes, 2298 patients receiving a Trifecta valve were 1:1 propensity matched from 17,281 patients receiving a PERIMOUNT bioprosthesis.

Results: Mean age at implant was 69 years in both matched groups. Compared with PERIMOUNT valves, early transvalvular mean gradient of Trifecta valves was lower (11 vs 15 mm Hg at 1 year, P < .001); however, its longitudinal rate of rise was greater (P < .001), resulting in 5-year mean gradients of 17 vs 16 mm Hg, and more patients experienced severe aortic regurgitation (2.4% vs 0.81%; P < .001). At 5 years, 35 Trifecta valves had been explanted vs 14 PERIMOUNT valves; freedom from explant at 1, 3, and 5 years was 98.9%, 98.0%, and 95.9%, respectively, for the Trifecta group vs 99.3%, 99.0%, and 98.7% for the PERIMOUNT group (P < .001).

Conclusions: Compared with an older-generation internally mounted bovine pericardial valve, the Trifecta externally wrapped bioprosthesis exhibits superior early hemodynamic performance, but has a rapid increase in transvalvular gradient and more aortic regurgitation, with lower freedom from explant at 5 years. These findings raise concern regarding long-term Trifecta durability despite favorable early hemodynamics.
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http://dx.doi.org/10.1016/j.athoracsur.2020.07.040DOI Listing
April 2021

Performance and Durability of Cryopreserved Allograft Aortic Valve Replacements.

Ann Thorac Surg 2021 06 25;111(6):1893-1900. Epub 2020 Sep 25.

Department of Thoracic and Cardiovascular Surgery, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Background: The value of allografts for aortic root replacement is controversial, with recent concern about limited durability. Currently, we prefer allografts for invasive infective endocarditis. Purposes of this study were to assess allograft performance and durability in our cumulative experience with aortic allografts.

Methods: From January 1987 to January 2017, 2042 adults received 2110 aortic allograft root replacements at our institution: 986 (47%) for infective endocarditis (669 [68%] for prosthetic valve endocarditis) and 1124 (53%) for other indications. Mean recipient age was 54 ± 15 years, and mean allograft donor age was 35 ± 13 years. Follow-up was 85% complete and comprised 17,253 patient-years of data. Longitudinal allograft performance was extracted from 6339 available echocardiographic studies. Durability was assessed by explant for allograft structural failure.

Results: Allograft mean gradient at hospital discharge was 6 mm Hg and 9, 13, and 15 mm Hg at 5, 10, and 15 years post-implant, respectively. Severe aortic regurgitation was 0% at hospital discharge, but 14%, 25%, and 35% at 5, 10, and 15 years, respectively. A total of 405 allografts were explanted for structural failure, actuarially 2%, 14%, 34%, and 51% at 5, 10, 15, and 20 years, respectively. Risk factors for structural failure were younger recipient age, larger body surface area, hypertension, and thoracic aorta disease; donor factors were older age and larger allograft size. Implant for infective endocarditis was not associated with accelerated structural failure.

Conclusions: This study affirms allografts' long-term acceptable hemodynamic performance and durability. Concern about structural failure should not limit allograft use. Recipient hypertension, allograft size, and donor age are modifiable risk factors.
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http://dx.doi.org/10.1016/j.athoracsur.2020.07.033DOI Listing
June 2021

Outcomes of Early Coronary Angiography or Revascularization After Cardiac Surgery.

Ann Thorac Surg 2021 05 16;111(5):1494-1501. Epub 2020 Sep 16.

Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Background: Early coronary ischemic events are uncommon after cardiac surgery, with little known about their management or associated outcomes. We evaluated clinical outcomes of patients undergoing coronary angiography ± percutaneous coronary intervention or redo coronary artery bypass grafting for suspected coronary ischemia within 3 weeks after index cardiac surgery.

Methods: This is a retrospective observational study based on data from 53,287 patients who underwent cardiac surgery at our institution (1996-2017); 180 patients (0.34%) satisfied the inclusion criteria. The primary outcome was 1-year all-cause mortality. Statistical evaluation involved χ, analysis of variance, Kaplan-Meier, and receiver operating characteristic curve analyses.

Results: Most coronary angiography ± percutaneous coronary intervention and redo coronary artery bypass grafting procedures occurred in the first 2 weeks after index cardiac surgery. Patients presenting with ST elevation myocardial infarction (STEMI)/non-STEMI had the lowest 1-year mortality (13.5%), followed by patients with ventricular tachycardia/fibrillation (28.1%), and patients with non-ventricular tachycardia/fibrillation arrest or hemodynamic instability alone the worst (38.6%) (χ = 17.3, P = .001). Peak troponin T level after cardiac surgery was strongly predictive of 1-year mortality (area under the curve, 0.74; 95% confidence interval, 0.65-0.84; P < .001) but did not predict the presence of coronary compromise. For acute graft failure, 1-year mortality was better with percutaneous coronary intervention (18.2%) than redo coronary artery bypass grafting (23.5%) or no indicated/feasible intervention (29.2%).

Conclusions: Although suspected myocardial ischemia requiring coronary angiography or intervention early after cardiac surgery was rare, mortality was high, particularly in presentations other than STEMI/non-STEMI. In patients with overt signs and symptoms of myocardial ischemia after index cardiac surgery, troponin T was not a reliable marker of underlying coronary or graft obstruction but was a robust predictor of 1-year mortality.
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http://dx.doi.org/10.1016/j.athoracsur.2020.06.113DOI Listing
May 2021

Impact of Transcatheter Aortic Valve Replacement on Severity of Chronic Kidney Disease.

J Am Coll Cardiol 2020 09;76(12):1410-1421

Thoracic and Cardiovascular Surgery, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio.

Background: The effect of transcatheter aortic valve replacement (TAVR) on kidney function stage in patients with aortic stenosis remains poorly understood. We hypothesized that in some patients, TAVR results in improved kidney function by alleviating cardiorenal syndrome.

Objectives: The purpose of this study was to assess change in chronic kidney disease (CKD) stage following TAVR, identify variables associated with pre- and post-TAVR estimated glomerular filtration rate (eGFR), and assess association of post-TAVR eGFR with mortality.

Methods: Patients (n = 5,190) receiving TAVR in the PARTNER (Placement of Aortic Transcatheter Valves) 1, 2, and PARTNER 2 S3 trials between April 2007 and October 2014 were included. Pre-TAVR and procedural variables associated with post-TAVR eGFR, change in CKD stage at ≤7 days post-TAVR, and association of post-TAVR eGFR on intermediate-term mortality were assessed.

Results: At baseline, CKD stage ≥2 was present in 91% of patients. CKD stage either improved or was unchanged following TAVR in the majority of patients (77% stage 1, 90% stage 2, 89% stage 3A, 94% stage 3B, and 99% stage 4). Progression to CKD stage 5 occurred in 1 (0.035%) of 2,892 patients within 7 days post-TAVR. Of 3,546 patients in whom data were available, 70 (2.0%) underwent post-TAVR dialysis. Higher pre-TAVR eGFR and transfemoral approach were strongly associated with higher post-TAVR eGFR. Lower baseline and longitudinal post-TAVR eGFR were associated with lower intermediate-term survival.

Conclusions: In patients with severe aortic stenosis undergoing TAVR, even with baseline impaired eGFR, CKD stage is more likely to stay the same or improve than worsen. Aortic stenosis may contribute to cardiorenal syndrome that improves with TAVR.
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http://dx.doi.org/10.1016/j.jacc.2020.07.048DOI Listing
September 2020

Non-small cell lung cancer in never- and ever-smokers: Is it the same disease?

J Thorac Cardiovasc Surg 2021 06 18;161(6):1903-1917.e9. Epub 2020 Jun 18.

Department of Thoracic and Cardiovascular Surgery, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Objectives: To investigate differences in presentation, pathology, and outcomes after resection of non-small cell lung cancer (NSCLC) in never-smokers versus ever-smokers.

Methods: From January 2006 to July 2016, 172 never-smokers and 1376 ever-smokers with NSCLC underwent pulmonary resection. The 2 cohorts were matched on patient characteristics, histopathological cancer cell type, and pathological stage group using a weighted balancing score, and overall survival and cancer recurrence were compared by pathological stage. Random forests for survival was used to identify granular cancer characteristics with different survival and cancer recurrence importance between groups.

Results: In never-smokers, the prevalence of NSCLC was more frequent in women than in men (63% [n = 109] vs 45% [n = 63]). Compared with ever-smokers, never-smokers had less upper-lobe disease (53% [n = 91] vs 62% [n = 855]) and more adenocarcinoma (88% [n = 151] vs 62% [n = 845]). Postoperative complications were similar. Never-smokers had a lower prevalence of non-lung cancer deaths than ever-smokers (13% vs 23% at 5 years; P = .006). Among matched pairs, never-smokers had better overall survival at 5 years in pathological stage I (96% vs 78%), but worse survival in stage II (54% vs 78%). Tumor size, N category, and histopathological cell type were more important drivers of mortality and cancer recurrence in never-smokers than in ever-smokers.

Conclusions: NSCLC in never-smokers affects women more than men and presents with different anatomic and histopathological distributions. Matched never-smokers have better or equivalent outcomes than ever-smokers in pathological stage I cancer, but are less likely to survive and to be cured of cancer as tumor burden increases. These findings suggest that there might be unique tumor or host behaviors differentially impacting survival of never- and ever-smoking patients with NSCLC.
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http://dx.doi.org/10.1016/j.jtcvs.2020.03.175DOI Listing
June 2021

Natural History of Pleural Complications After Lung Transplantation.

Ann Thorac Surg 2021 02 24;111(2):407-415. Epub 2020 Aug 24.

Department of Thoracic and Cardiovascular Surgery, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio; Transplant Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Background: Despite advances in lung transplantation, 5-year survival remains at 56%. Although the focus has been on chronic lung allograft dysfunction and infection, pleural complications in some may contribute to adverse outcomes. Therefore, we determined (1) the prevalence of, and risk factors for, pleural complications after lung transplantation and (2) their association with allograft function and mortality.

Methods: From 2006 to 2017, 1039 adults underwent primary lung transplantation at Cleveland Clinic in Cleveland, Ohio. Multivariable analyses were performed in the multiphase mixed longitudinal and hazard function domains to identify risk factors associated with allograft function and survival.

Results: A total of 468 patients (45%) had pleural complications, including pleural effusion in 271 (26%), pneumothorax in 152 (15%), hemothorax in 128 (12%), empyema in 47 (5%), and chylothorax in 9 (1%). Risk factors for pleural complications within the first 3 months included higher recipient-to-donor weight ratio, lower recipient albumin, and recipient-to-donor race mismatch; risk factors extending beyond 3 months included older age, hypertension, smoking history, lower lung allocation score, and donor death from anoxia. Cardiopulmonary bypass and previous thoracic interventions were not risk factors in patients with pleural effusions who were treated with thoracentesis only, and forced expiratory volume in 1 second improved after drainage; however, repeat percutaneous or surgical interventions did not impart a similar benefit. Pleural complications were associated with worse survival.

Conclusions: Pleural complications are common after lung transplantation and are associated with worse allograft function and survival. These complications are likely secondary to other underlying clinical problems. Malnourishment and size mismatch are modifiable risk factors.
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February 2021
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