Expert Opinions on the Debate of Pericardial Reconstruction in Cardiovascular Surgery: To Close or Not to Close?

BACKGROUND: As of 2019, pericardial closure was performed in only a small portion of the over 320,000 cardiac surgeries performed annually. However, evidence regarding the benefits of pericardial closure or reconstruction has been accruing, particularly with the publication of the RECON study in 2019.  Methods: This group of authors convened to try to arrive at consensus expert opinion regarding pericardial reconstruction. Structured topic questions initially were used to stimulate discussion. Subsequently, a survey of proposed expert opinion statements was conducted among the authors. Based on that survey, consensus expert opinion statements and recommendations were compiled. RESULTS: The expert opinions encompass various topics relating to pericardial reconstruction, including definitions, benefits/risks, and technique. Observed benefits include reductions in: (1) adhesions; (2) postoperative pericardial effusion, atrial fibrillation, and bleeding; and (3) readmissions and length of hospital stay. Expert opinion recommendations regarding surgical technique are compiled into a single chart. Complete pericardial reconstruction should be performed, using native pericardial tissue if available and viable; if not feasible, a patch may be used. Patches that stimulate the formation of site-specific tissue in situ (such as natural extracellular matrix) may have additional benefits (including bioregenerative properties and lack of inflammatory response). Closure should be taut, but tension-free. Adequate drainage of the closed pericardium must be ensured. CONCLUSIONS: Based on available data and collective surgical experience, we endorse pericardial reconstruction as standard approach in appropriately selected patients. We also endorse adoption of standardized pericardial reconstruction techniques to optimize patient outcomes and improve evidence quality in future studies.

PROSE: Prospective Randomized Trial of the On-X Mechanical Prosthesis and the St Jude Medical Mechanical Prosthesis Evaluation: Part 2: Study results-prostheses, positions, and economic development.

Objectives: The Prospective Randomized On-X Mechanical Prosthesis Versus St Jude Medical Mechanical Prosthesis Evaluation (PROSE) trial purpose was to investigate whether a current-generation mechanical prosthesis (On-X; On-X Life Technologies/Artivion Inc) reduced the incidence of thromboembolic-related complications compared with a previous-generation mechanical prosthesis (St Jude Medical Mechanical Prosthesis; Abbott/St Jude Medical). This second report documents the valve-related complications by individual prostheses and by Western and Developing populations. Methods: The PROSE trial study was conducted in 28 worldwide centers and incorporated 855 subjects randomized between 2003 and 2016. The study enrollment was discontinued on August 31, 2016. The study protocol, and analyses of 10 demographic variables and 24 risk factors were published in detail in 2021. Results: The total patient population (N = 855) included patients receiving an On-X valve (n = 462) and a St Jude Medical valve (n = 393). The overall freedom evaluation showed no differences at 5 years between the prostheses for thromboembolism or for valve thrombosis. There were also no differences in mortality. There were several differences between Developing and Western populations. The freedom relations at 5 years for mortality favored Western over Developing populations. Valve thrombosis was differentiated by position and site: aortic < mitral (P = .007) and Western < Developing (P = .005). In the mitral position there were no cases in Western populations, whereas there were 8 in Developing populations (P = .217). Conclusions: The On-X valve and St Jude Medical valve performed equally well in the study with no differences found. The only differentiation occurred with valve thrombosis in the mitral position more than the aortic position and occurring in Developing more than Western populations. The occurrence of valve thrombosis was also related to a younger population possibly due to anticoagulation compliance based on record review.

PROSE: Prospective Randomized Trial of the On-X Mechanical Prosthesis and the St Jude Medical Mechanical Prosthesis Evaluation : Part 1(Patient Dynamics): Preoperative demographics and preoperative and operative risk factors.

OBJECTIVES: The PROSE trial purpose is to investigate whether the incidence of thromboembolic-related complications is reduced with a current generation mechanical prosthesis (On-X Life Technologies/CryoLife Inc.-On-X) compared with a previous generation mechanical prosthesis (St Jude Medical-SJM). The primary purpose of the initial report is to document the preoperative demographics, and the preoperative and operative risk factors by individual prosthesis and by Western and Developing populations. METHODS: The PROSE study was conducted in 28 worldwide centres and incorporated 855 subjects randomized between 2003 and 2016. The study enrollment was discontinued on August 31, 2016. The preoperative demographics incorporated age, gender, functional class, etiology, prosthetic degeneration, primary rhythm, primary valve lesion, weight, height, BSA and BMI. The preoperative and operative evaluation incorporated 24 risk factors. RESULTS: The total patient population (855) incorporated On-X population (462) and the St Jude Medical population (393). There was no significant difference of any of the preoperative demographics between the On-X and SJM groups. The preoperative and operative risk factors evaluation showed there was no significant difference between the On-X and St Jude Medical populations. The preoperative and operative risk factors by valve position (aortic and mitral) also documented no differentiation. The dominant preoperative demographics of the Western world population were older age, male gender, sinus rhythm, aortic stenosis, congenital aortic lesion, and mitral regurgitation. The dominant demographics of the Developing world population were rheumatic etiology, atrial fibrillation, aortic regurgitation, mixed aortic lesions, mitral stenosis and mixed mitral lesions. The Developing world group had only one significant risk factor, congestive heart failure. The majority of the preoperative and operative risk factors were significant in the Western world population. CONCLUSIONS: The preoperative demographics do not differentiate the prostheses but do differentiate the Western and Developing world populations. The preoperative and operative risk factors do not differentiate the prostheses BUT do differentiate the Western and Developing world populations.

Impact of Surgical Experience on Operative Mortality After Reoperative Cardiac Surgery.

BACKGROUND: Learning curves and skill attrition with aging have been reported to impair outcomes in select surgical subspecialties, but their role in complex cardiac surgery remains unknown. METHODS: From 1986 to 2019, 2314 patients underwent reoperative cardiac surgery: coronary artery bypass grafting (n = 543), valve (n = 1527), or combined coronary artery bypass grafting and valve (n = 244). Thirty-four different surgeons in practice between 1 and 39 years were included. Standardized mortality ratio (observed-to-expected) was determined for all surgeons in each post-training year of experience. RESULTS: Risk-adjusted cumulative sum change-point analysis was used to define five distinct career phases: 0 to 4 years, 5 to 8 years, 9 to 17 years, 18 to 28 years, and 29 to 39 years. With 5 to 8 years and 18 to 28 years of experience, standardized mortality ratio was near unity (0.95 and 1.05, respectively) and lowest with 9 to 17 years of experience (0.78, P = .03). In the youngest experience group (0 to 4 years), observed and expected mortality were both highest, and standardized mortality ratio was elevated at 1.29, which approached statistical significance (P = .059). In the oldest experience group (29 to 39 years), expected mortality was low compared with most other groups but observed mortality increased, yielding a significantly elevated standardized mortality ratio at 1.53 (P = .032). CONCLUSIONS: Standardized mortality ratios with reoperative cardiac surgery were highest early and late in a surgeon's career and lowest in mid career. As surgeons gain experience, outcomes improve through the first two career decades, then stabilize in the third decade before declining in the fourth decade.

A 20-year multicenter analysis of dialysis-dependent patients who had aortic or mitral valve replacement: Implications for valve selection.

OBJECTIVE: Valve selection in dialysis-dependent patients can be difficult because long-term survival is diminished and bleeding risks during anticoagulation treatment are greater in patients with renal failure. In this study we analyzed long-term outcomes of dialysis-dependent patients who underwent valve replacement to help guide optimal prosthetic valve type selection. METHODS: Dialysis-dependent patients who underwent aortic and/or mitral valve replacement at 3 institutions over 20 years were examined. The primary outcome was long-term survival. A Cox regression model was used to estimate survival according to 5 ages, presence of diabetes, and/or heart failure symptoms. RESULTS: Four hundred twenty-three available patients were analyzed; 341 patients had biological and 82 had mechanical valves. Overall complication and 30-day mortality rates were similar between the groups. Thirty-day readmission rates for biological and mechanical groups were 15% (50/341) and 28% (23/82; P = .005). Five-year survival was 23% and 33% for the biological and mechanical groups, respectively. After adjusting for age, New York Heart Association (NYHA) class, and diabetes using a multivariable Cox regression model, survival was similar between groups (hazard ratio, 0.93; 95% confidence interval, 0.66-1.29; P = .8). A Cox regression model on the basis of age, diabetes, and heart failure, estimated that patients only 30 or 40 years old, with NYHA class I-II failure without diabetes had a >50% estimated 5-year survival (P < .001). CONCLUSIONS: Dialysis-dependent patients who underwent valve replacement surgery had poor long-term survival. Young patients without diabetes or NYHA III or IV symptoms might survive long enough to justify placement of a mechanical valve; however, a biological valve is suitable for most patients.

Pulmonary Artery Intimal Sarcoma: A Case Report.

Pulmonary artery intimal sarcomas are rare and lethal malignant tumors that typically affect larger vessels: the aorta, inferior vena cava, and pulmonary arteries. Since symptoms and imaging of pulmonary arterial intimal sarcomas mimic pulmonary thromboembolism, the differential diagnosis of a patient presenting with chest pain, dyspnea, and filling defect within the pulmonary arteries should include intimal sarcoma. Often right ventricular failure is observed due to pulmonary hypertension caused by the obstructive effect of the tumor and concomitant chronic thromboembolism. We report the case of a 72-year-old African-American male with arterial intimal sarcoma of the left and right pulmonary artery with extension through the right artery into the bronchus and right lung.

A Reminder of Methylene Blue's Effectiveness in Treating Vasoplegic Syndrome after On-Pump Cardiac Surgery.

The inflammatory response induced by cardiopulmonary bypass decreases vascular tone, which in turn can lead to vasoplegic syndrome. Indeed the hypotension consequent to on-pump cardiac surgery often necessitates vasopressor and intravenous fluid support. Methylene blue counteracts vasoplegic syndrome by inhibiting the formation of nitric oxide. We report the use of methylene blue in a 75-year-old man who developed vasoplegic syndrome after cardiac surgery. After the administration of methylene blue, his hypotension improved to the extent that he could be weaned from vasopressors. The use of methylene blue should be considered in patients who develop hypotension refractory to standard treatment after cardiac surgery.

Incremental risk of the Cox-maze IV procedure for patients with atrial fibrillation undergoing mitral valve surgery.

OBJECTIVE: More than 50% of atrial fibrillation surgery occurs in the setting of mitral valve surgery. Despite this, no risk models have been validated for concomitant arrhythmia surgery. The purpose of the present study was to quantify the additional risk of performing the Cox-maze IV procedure for patients undergoing mitral valve surgery. METHODS: From January 2002 to June 2011, 213 patients with mitral valve disease and preoperative atrial fibrillation underwent mitral valve surgery only (n = 109) or in conjunction with a Cox-maze IV procedure (n = 104). The operative mortality for the mitral valve procedure alone was predicted for each group using the Society of Thoracic Surgeons perioperative risk calculator. The risk attributed to the added Cox-maze IV procedure was calculated by comparing the predicted mortality rate of an isolated mitral valve procedure and the actual mortality rate of mitral valve surgery with a concomitant Cox-maze IV procedure. RESULTS: For patients not undergoing a Cox-maze IV procedure, the predicted and actual postoperative mortality rate was 5.5% and 4.6% (5 of 109), respectively. For patients receiving mitral valve surgery and a concomitant Cox-maze IV, the predicted and actual postoperative mortality of the mitral valve procedure was 2.5% and 2.9% (3 of 104), respectively, and not significantly different. Patients not offered a Cox-maze IV procedure had significantly more serious comorbidities. CONCLUSIONS: For patients with atrial fibrillation and mitral valve disease undergoing mitral valve surgery, the decision to offer a concomitant Cox-maze IV procedure will be influenced by the underlying comorbid conditions. Nonetheless, in selected lower risk patients, the addition of a Cox-maze IV procedure did not significantly affect the procedural mortality.

Cox-Maze IV results for patients with lone atrial fibrillation versus concomitant mitral disease.

BACKGROUND: This study compared Cox-Maze IV (CMIV) outcomes for the treatment of atrial fibrillation (AF) in patients with lone AF vs those with AF and mitral valve (MV) disease. METHODS: Since 2002, 200 patients have undergone a CMIV procedure for lone AF (n=101) or concomitantly with MV operations (n=99). Preoperative, perioperative, and late outcomes between these groups were compared. Data were collected prospectively and reported at 3, 6, and 12 months. RESULTS: Lone AF patients had AF of longer duration; patients with AF and MV disease were older, with larger left atria and worse New York Heart Association classification (p<0.05). Operative mortality (1% vs 4%, p>0.05, respectively) was similar between both groups. Perioperative atrial tachyarrhythmias were more prevalent in patients with concomitant MV operations (57% vs 41%, p=0.03); however, freedom from AF and antiarrhythmics was similar for both groups at 12 months (76% and 77%). The only predictor for atrial tachyarrhythmia recurrence or arrhythmic drug dependence was failure to isolate the posterior left atrium (p<0.01). CONCLUSIONS: Patients with AF and MV disease have distinct comorbidities compared with patients with lone AF. However, the CMIV is safe and effective in both groups and should be considered for patients with AF undergoing MV operations. Patients with MV disease had more atrial tachyarrhythmias at 3 months, but freedom from AF and antiarrhythmics was similar to patients with lone AF at 1 year. The posterior left atrium should be isolated in every patient, because this was the only predictor for failure of the CMIV for either group.

The Cox maze IV procedure: predictors of late recurrence.

OBJECTIVES: The Cox maze III procedure achieved high cure rates and became the surgical gold standard for the treatment of atrial fibrillation. Because of its invasiveness, a more simplified ablation-assisted procedure, the Cox maze IV procedure, has been performed at our institution since January 2002. The study examined multiple preoperative and perioperative variables to determine predictors of late recurrence. METHODS: Data were collected prospectively on 282 patients who underwent the Cox maze IV procedure from January 2002 through December 2009. Forty-two percent of patients had paroxysmal and 58% had either persistent or long-standing persistent atrial fibrillation. All patients were available for follow-up. Follow-up included electrocardiograms in all patients. Since 2006, 24-hour Holter monitoring was obtained in 94% of patients at 3, 6, and 12 months. Data were analyzed by means of logistic regression analysis at 12 months, with 13 preoperative and perioperative variables used as covariates. RESULTS: Sixty-six percent of patients had a concomitant procedure. After an ablation-assisted Cox maze procedure, the freedom from atrial fibrillation was 89%, 93%, and 89% at 3, 6, and 12 months, respectively. The freedom from both atrial fibrillation and antiarrhythmic drugs was 63%, 79%, and 78% at 3, 6, and 12 months, respectively. The risk factors for atrial fibrillation recurrence at 1 year were enlarged left atrial diameter (P = .027), failure to isolate the entire posterior left atrium (P = .022), and early atrial tachyarrhythmias (P = .010). CONCLUSIONS: The Cox maze IV procedure has a high success rate at 1 year, even with improved follow-up and stricter definitions of failure. In patients with large left atria, there might be a need for more extensive size reduction or expanded lesion sets.

POINT: Prosthesis-patient mismatch does not affect survival for patients greater than 70 years of age undergoing bioprosthetic aortic valve replacement.

OBJECTIVE: The purpose of this investigation was to examine the impact of prosthesis-patient mismatch after bioprosthetic aortic valve replacement on long-term survival in patients greater than 70 years of age compared with those less than or equal to 70 years of age. METHODS: Between 1992 and 2007, 1399 patients underwent bioprosthetic aortic valve replacement, including 881 (63%) patients older than 70 years of age. Prosthesis-patient mismatch was defined as severe (prosthetic effective orifice area/body surface area < 0.65 cm(2)/m(2)), moderate (0.65-0.85 cm(2)/m(2)), or absent (>0.85 cm(2)/m(2)). For patients less than or equal to 70 years of age, mismatch was severe in 62 (12%), moderate in 251 (48%), and absent in 205 (40%). For patients greater than 70 years of age, mismatch was severe in 109 (12%), moderate in 451 (51%), and absent in 321 (37%). There was no difference in the distribution of prosthesis-patient mismatch between age groups (P = .50). RESULTS: For patients less than or equal to 70 years, prosthesis-patient mismatch was associated with impaired long-term survival (P = .02). Survival at 5 and 10 years was 61% +/- 7% and 28% +/- 12% for severe mismatch, 65% +/- 3% and 40% +/- 5% for moderate mismatch, and 73% +/- 5% and 46% +/- 9% for no mismatch. For patients greater than 70 years, prosthesis-patient mismatch did not affect long-term survival (P = .25). Survival at 5 and 10 years was 62% +/- 5% and 42% +/- 6% for severe mismatch, 62% +/- 2% and 30% +/- 5% for moderate mismatch, and 53% +/- 4% and 29% +/- 5% for absent mismatch. CONCLUSIONS: After bioprosthetic aortic valve replacement, prosthesis-patient mismatch had a negative impact on late survival for patients less than or equal to 70 years of age, but for patients greater than 70 years of age, prosthesis-patient mismatch did not influence late survival.

Isolating the entire posterior left atrium improves surgical outcomes after the Cox maze procedure.

OBJECTIVES: The importance of each ablation line in the Cox maze procedure for treatment of atrial fibrillation remains poorly defined. This study evaluated differences in surgical outcomes of the procedure performed either with a single connecting lesion between the right and left pulmonary vein isolations versus 2 connecting lesions (the box lesion), which isolated the entire posterior left atrium. METHODS: Data were collected prospectively on 137 patients who underwent the Cox maze procedure from April 2002 through September 2006. Before May 2004, the pulmonary veins were connected with a single bipolar radiofrequency ablation lesion (n = 56), whereas after this time, a box lesion was routinely performed (n = 81). The mean follow-up was 11.8 +/- 9.6 months. RESULTS: The incidence of early atrial tachyarrhythmia was significantly higher in the single connecting lesion group compared with that in the box lesion group (71% vs 37%, P < .001). The overall freedom from atrial fibrillation recurrence was significantly higher in the box lesion group at 1 (87% vs 69%, P = .015) and 3 (96% vs 85%, P = .028) months. The use of antiarrhythmic drugs was significantly lower in the box lesion group at 3 (35% vs 58%, P = .018) and 6 (15% vs 44%, P = .002) months. CONCLUSIONS: Isolating the entire posterior left atrium by creating a box lesion instead of a single connecting lesion between the pulmonary veins showed a significantly lower incidence of early atrial tachyarrhythmias, higher freedom from atrial fibrillation recurrence at 1 and 3 months, and lower use of antiarrhythmic drugs at 3 and 6 months. A complete box lesion should be included in all patients undergoing the Cox maze procedure.

Prosthesis-patient mismatch after aortic valve replacement: impact of age and body size on late survival.

BACKGROUND: The purpose of this study was to identify patient subgroups in which prosthesis-patient mismatch most influenced late survival. METHODS: Over a 12-year period, 1,400 consecutive patients underwent bioprosthetic (933 patients) or mechanical (467) aortic valve replacement. Prosthesis-patient mismatch was defined as prosthetic effective orifice area/body surface area less than 0.75 cm2/m2 and was present with 11% mechanical and 51% bioprosthetic valves. RESULTS: With bioprosthetic valves, prosthesis-patient mismatch was associated with impaired survival for patients less than 60 years old (10-year: 68% +/- 7% mismatch versus 75% +/- 7% no mismatch, p < 0.02) but not older patients (p = 0.47). Similarly, with mechanical valves, prosthesis-patient mismatch was associated with impaired survival for patients less than 60 years old (10-year: 62% +/- 11% versus 79% +/- 4%, p < 0.005) but not older patients (p = 0.26). For small patients (body surface area less than 1.7 m2), prosthesis-patient mismatch did not impact survival with bioprosthetic (p = 0.32) or mechanical (p = 0.71) valves. For average-size patients (body surface area 1.7 to 2.1 m2), prosthesis-patient mismatch was associated with impaired survival with both bioprosthetic (p < 0.05) and mechanical (p < 0.005) valves. For large patients (body surface area greater than 2.1 m2), prosthesis-patient mismatch was associated with impaired survival with mechanical (p < 0.04) but not bioprosthetic (p = 0.40) valves. CONCLUSIONS: Prosthesis-patient mismatch had a negative impact on survival for young patients, but its impact on older patients was minimal. In addition, although prosthesis-patient mismatch was not important in small patients, prosthesis-patient mismatch negatively impacted survival for average-size patients and for large patients with mechanical valves.