Minimally invasive versus conventional aortic valve replacement: The network meta-analysis.

BACKGROUND: Outcome comparisons after surgical aortic valve replacement (SAVR) with minimally invasive approaches including mini-sternotomy (MS) and right mini-thoracotomy (RMT) and full sternotomy (FS) have been conflicting. Furthermore, the synthesis of mid-term mortality has not been performed. METHODS: MEDLINE and EMBASE were searched through April 2022 to identify propensity score matched (PSM) studies or randomized controlled trial (RCT) which compared outcomes following SAVR among three incisional approaches: FS, MS, or RMT. The network analysis was performed to compare these approaches with random effects model. Mid-term mortality was defined as 1-year mortality. RESULTS: A total of 42 studies met the inclusion criteria enrolling 14,925 patients. RCT and PSM were performed in 13 and 29 studies, respectively. The operative mortality was significantly lower with MS compared to FS (risk ratio [RR]: 0.60, 95% confidence interval [CI]: 0.41-0.90, p = .01, I2 = 25.8%) or RMT (RR: 0.51, 95% CI: 0.27-0.97, p = .03, I2 = 25.8%). RMT had significantly higher risk of reoperation for bleeding compared to MS (RR: 1.65, 95% CI: 1.18-2.30, p = .003, I2 = 0%). Hospital length of stay was significantly shorter with MS compared to FS (mean difference: -0.89 days, 95% CI: -1.58 to -0.2, p = .01, I2 = 95.5%) while it was equivocal between FS and RMT. The mid-term mortality was similar among the three approaches. CONCLUSIONS: While mid-term mortality was comparable among approaches, MS may be a safe and potentially more effective approach than FS and RMT for SAVR in the short term.

The impact of reoperative surgery on aortic root replacement in the United States.

OBJECTIVE: Reoperative sternotomy is associated with poor outcomes after cardiac surgery. We aimed to investigate the impact of reoperative sternotomy on the outcomes after aortic root replacement. METHODS: All patients who underwent aortic root replacement from January 2011 to June 2020 were identified using the Society of Thoracic Surgeons Adult Cardiac Surgery Database. We compared outcomes between patients who underwent first-time aortic root replacement with those with a history of sternotomy undergoing reoperative sternotomy aortic root replacement using propensity score matching. Subgroup analysis was performed among the reoperative sternotomy aortic root replacement group. RESULTS: A total of 56,447 patients underwent aortic root replacement. Among them, 14,935 (26.5%) underwent reoperative sternotomy aortic root replacement. The annual incidence of reoperative sternotomy aortic root replacement increased from 542 in 2011 to 2300 in 2019. Aneurysm and dissection were more frequently observed in the first-time aortic root replacement group, whereas infective endocarditis was more common in the reoperative sternotomy aortic root replacement group. Propensity score matching yielded 9568 pairs in each group. Cardiopulmonary bypass time was longer in the reoperative sternotomy aortic root replacement group (215 vs 179 minutes, standardized mean difference = 0.43). Operative mortality was higher in the reoperative sternotomy aortic root replacement group (10.8% vs 6.2%, standardized mean difference = 0.17). In the subgroup analysis, logistic regression demonstrated that individual patient repetition of (second or more resternotomy) surgery and annual institutional volume of aortic root replacement were independently associated with operative mortality. CONCLUSIONS: The incidence of reoperative sternotomy aortic root replacement might have increased over time. Reoperative sternotomy is a significant risk factor for morbidity and mortality in aortic root replacement. Referral to high-volume aortic centers should be considered in patients undergoing reoperative sternotomy aortic root replacement.

External validation of the ARCH score in patients undergoing aortic arch reconstruction under circulatory arrest.

BACKGROUND: Aortic arch surgery with hypothermic circulatory arrest (HCA) carries a higher risk of morbidity and mortality compared to routine cardiac surgical procedures. The newly developed ARCH (arch reconstruction under circulatory arrest with hypothermia) score has not been externally validated. We sought to externally validate this score in our local population. METHODS: All consecutive open aortic arch surgeries with HCA performed between 2014 and 2023 were included. Univariable and multivariable analyses were performed. Model discrimination was assessed by the C-statistic with 95% confidence intervals as part of the receiver operating characteristic (ROC) curve analysis. Model performance was visualized by a calibration plot and quantified by the Brier score. RESULTS: A total of 760 patients (38.3% females) were included. The mean age was 61 (±13.6) years, with 56.4% of patients' age >60 years. The procedures were carried out mostly emergently or urgently (59.6%). Total arch replacement was performed in 32.5% of the patients, and aortic root procedures were carried out in 74.6%. In-hospital death occurred in 64 patients (8.4%), and stroke occurred in 5.4%. The C-statistic revealed a low discriminatory ability for predicting in-hospital mortality (area under the ROC curve, 0.62; 95% confidence interval, 0.54-0.69; P = .002); however, model calibration was found to be excellent (Brier score of 0.07). CONCLUSIONS: The ARCH score for in-hospital mortality showed low discriminatory ability in our local population, although with excellent ability for prediction of mortality.

How to Do It: Transbrachial Impella Placement to Facilitate Percutaneous Coronary Intervention.

A 64-year-old man with diffusely diseased iliofemoral vessels and an ejection fraction of 20% to 25% presented with a non-ST elevation myocardial infarction and proximal left anterior descending (LAD) and left circumflex (LCx) coronary artery disease, with a chronically occluded right coronary artery. The iliofemoral system was not suitable for Impella placement, and bilateral axillary arteries were heavily calcified. The proximal left brachial artery was chosen for placement of both an Impella CP (Abiomed, Danvers, MA, USA) and percutaneous coronary intervention (PCI) sheath through a graft sewn to the brachial artery in this single-access technique. A 6 mm graft was sewn to the brachial artery, through which the Impella CP was placed. The Impella CP sheath was then used to introduce a 7F sheath for PCI. Successful PCI with drug-eluting stents was carried out to the LAD and LCx arteries, the Impella was weaned and removed, and the graft was stapled. The patient was discharged without any access or PCI complications. This report demonstrates the feasibility of the single-access Impella technique through a brachial artery cutdown approach.

Complete revascularization during coronary artery bypass grafting is associated with reduced major adverse events.

OBJECTIVE: Complete revascularization literature is limited by variance in patient cohorts and inconsistent definitions. The objective of the current study was to provide risk-adjusted outcomes for complete revascularization of significant nonmain-branch and main-branch vessel stenoses. METHODS: All patients that underwent first-time isolated coronary artery bypass grafting procedures were included. Kaplan-Meier survival estimates, cumulative incidence function, and Cox regression were used to analyze outcomes. RESULTS: The total population consisted of 3356 patients that underwent first-time isolated coronary artery bypass grafting. Eight hundred eighty-nine (26.5%) patients had incomplete and 2467 (73.5%) had complete revascularization. For main-branch vessels, 677 (20.2%) patients had incomplete revascularization and 2679 (79.8%) were completely revascularized. Following risk adjustment with inverse probability treatment weighting, all baseline characteristics were balanced (standardized mean difference, ≤ 0.10). On Kaplan-Meier estimates, survival at 1 year (94.6% vs 92.5%) and 5 years (86.5% vs 82.1%) (P = .05) was significantly better for patients who received complete revascularization. Freedom from major adverse cardiac and cerebrovascular events was significantly higher for the complete revascularization cohort at both 1 year (89.2% vs 84.2%) and 5 years (72.5% vs 66.7%) (P < .001). Complete revascularization (hazard ratio, 0.82; 95% confidence interval, 0.70-0.95; P = .01) was independently associated with a significant reduction in major adverse cardiac and cerebrovascular events. Incomplete revascularization of nonmain-branch vessels was not associated with mortality (hazard ratio, 1.14; 95% confidence interval, 0.74-1.8; P = .55) or major adverse cardiac and cerebrovascular events (hazard ratio, 0.90; 95% confidence interval, 0.66-1.24; P = .52). CONCLUSIONS: Complete surgical revascularization of all angiographically stenotic vessels in patients with multivessel coronary artery disease is associated with fewer major adverse events. Incomplete revascularization of nonmain-branch vessels is not associated with survival or major adverse cardiac and cerebrovascular events.

Matched Analysis of Surgical Versus Percutaneous Revascularization for Left Main Coronary Disease.

BACKGROUND: Percutaneous coronary intervention (PCI) is being performed more frequently for left main coronary artery disease (LMCAD). This study evaluated a real-world propensity-matched analysis of surgical vs percutaneous revascularization for LMCAD. METHODS: Adults (≥18 years of age) at a single academic institution undergoing coronary artery bypass grafting (CABG) or PCI for left main stenosis greater than or equal to 50% between 2010 and 2018 were examined. Greedy propensity-matching techniques were used to generate well-matched cohorts, and Kaplan-Meier analysis was used to compare survival. Multivariable Cox models were created for 5-year mortality and major adverse cardiac and cerebrovascular events (MACCE). RESULTS: A total of 1091 patients with LMCAD were identified (898 CABG, 193 PCI). Patients undergoing PCI were significantly older (77 years of age vs 68 years of age; P < .001), more likely to have heart failure (26.94% vs 13.14%; P < .001), and less likely to have 3-vessel disease (42.49% vs 65.59%; P < .001). Propensity matching yielded 215 CABG and 134 PCI well-matched patients. In the matched analysis, 1-year (77.61% vs 88.37%) and 5-year (48.77% vs 75.62%) survival were lower with PCI. Rates of MACCE at 5 years were also higher with PCI (64.93% vs 32.56%; P < .001). Rates of both myocardial infarction (19.40% vs 7.44%; P = .001) and repeat revascularization (26.12% vs 7.91%; P < .001) were higher with PCI. After risk adjustment, CABG remained associated with reduced risk of mortality (hazard ratio, 0.40; 95% confidence interval, 0.29-0.54; P < .001) and MACCE (hazard ratio, 0.37; 95% confidence interval, 0.28-0.48; P < .001) at 5 years. CONCLUSIONS: This real-world, propensity-matched analysis demonstrates substantial advantages in survival and MACCE with CABG for LMCAD, supporting surgical revascularization in this clinical setting in appropriate operative candidates.

High-Risk Committee for Cardiac Surgery Decision-Making: Results From 110 Consecutive Patients.

BACKGROUND: This study evaluated our institutional experience in forming a surgeon-based committee to discuss and provide consensus opinion on high-risk cardiac surgical cases. METHODS: The committee consisted of 4 surgeons with at least 1 senior surgeon at any given time with a rotating schedule. Patients with a Society of Thoracic Surgeons predicted risk of mortality above specified thresholds were mandated for referral to the committee in addition to patients referred at the discretion of the surgeon. Kaplan-Meier analysis was used to model survival. RESULTS: A total of 110 consecutive patients were reviewed by the committee. The most common procedure types for referral were isolated coronary artery bypass grafting (47.3%; n = 52) and coronary artery bypass grafting with concomitant aortic valve replacement (19.1%; n = 21). The overall median Society of Thoracic Surgeons predicted risk of mortality for referred patients was 5.35% (interquartile range, 4.07%-7.89%). After group discussion, a total of 62 patients were recommended to proceed with surgery (56.4%). Reasons for declining surgery included consensus that an intervention was not indicated (39.6%; n = 19), that an alternative, nonsurgical procedure was recommended (29.2%; n = 14), that there was continued medical management and reevaluation (18.8%; n = 9), and that the patient was deemed at too high a risk for surgery (12.5%; n = 6). Operative mortality in patients proceeding with surgery was 4.6% (n = 2), with an observed-to-expected mortality of 0.86. The 6-month survival after surgery was 92.2%. CONCLUSIONS: Implementation of a surgeon-based committee to discuss high-risk cases provided a unified voice to referring physicians and facilitated consensus decision-making with acceptable clinical outcomes in a challenging patient cohort.

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

OBJECTIVE: There is an increasing amount of evidence supporting use of transcatheter aortic valve replacement (TAVR) for treatment of aortic stenosis in patients at low or intermediate risk for surgical aortic valve replacement (SAVR). TAVR is now approved for use in all patient cohorts. Despite this, there remains debate about the relative efficacy of TAVR compared with SAVR in lower-risk cohorts and various subgroups of patients. We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) and propensity-matched trials to guide a consensus among expert cardiologists and surgeons. METHODS: Studies comparing TAVR and SAVR in low- and intermediate-risk patients were identified by a thorough search of the major databases. Mortality, stroke, and other perioperative outcomes were assessed at 30 days and 1 year. RESULTS: Early mortality was lower in TAVR compared to SAVR in RCTs, but not propensity-matched studies in low-risk cohorts (0.66% vs 1.5%; odds ratio [OR] = 0.44, 95% confidence interval [CI] 0.20 to 0.98, I2 = 0%). No difference in mortality between TAVR and SAVR was identified in intermediate-risk patients at early or later time points. Incidence of perioperative stroke in 3 low-risk RCTs was significantly lower in TAVR (0.4%) than SAVR (1.4%; OR = 0.33, 95% CI 0.13 to 0.81, I2 = 0%). There was no difference in stroke for intermediate-risk patients between TAVR and SAVR. The expert panel of cardiologists and cardiac surgeons provided recommendations for TAVR and SAVR in various clinical scenarios. CONCLUSIONS: In RCTs comparing TAVR and SAVR in low-risk patients, early mortality and stroke were lower in TAVR, but did not differ at 1 year. There was no difference in mortality and stroke in intermediate-risk patients. The Multidisciplinary Heart Team must consider individual patient characteristics and preferences when recommending TAVR or SAVR. The decision must consider the long-term management of each patient's aortic valve disease.

The impact of immediate extubation in the operating room after cardiac surgery on intensive care and hospital lengths of stay.

OBJECTIVE: To determine if lengths of stay in intensive care and the hospital are associated with extubation in the operating room at the conclusion of cardiac surgery. DESIGN: A nonrandomized, observational study with propensity score-guided case-control matching of prospectively collected data. SETTING: Three interrelated, university-affiliated, community hospitals. PARTICIPANTS: Three thousand three hundred seventeen patients undergoing elective or urgent coronary artery, valve repair or replacement, or combined surgery between 2000 and 2006. INTERVENTIONS: Tracheal extubation occurred, based on history and intraoperative events, either immediately in the operating room or in the intensive care unit. MEASUREMENTS AND MAIN RESULTS: Of 3,317 patients in the institutions' Society of Thoracic Surgeons database, 3,089 were extubated within 24 hours, 69% of them in the operating room. Only 0.6% of patients extubated in the operating room required reintubation, compared with 5.9% extubated in the intensive care unit (p < 0.0001). By logistic regression, 12 of 25 preoperative and intraoperative factors generated a propensity score for each of the 2,595 patients with complete data, representing the likelihood of immediate extubation (c-statistic = 0.727). A "greedy 5 to 1" propensity score-matching technique created 713 matched pairs of patients by extubation pathway. Those undergoing immediate extubation had reductions in intensive care duration by 23 hours on average (median from 46 to 27 hours, p < 0.0001) and in hospital length of stay by 0.8 days on average (median = 6 for each, p < 0.0001). Cox regression, using matched pairs as strata, identified the following independent predictors of length of stay in the intensive care unit and hospital: immediate extubation in the operating room, need for reintubation, postoperative renal failure, and postoperative atrial fibrillation. CONCLUSIONS: Selection of patients for immediate extubation in the operating room by experienced clinicians was associated with shorter ICU and hospital stays. Immediate extubation rarely resulted in tracheal re-intubation.

Endoscopic Conduit Harvest in Coronary Artery Bypass Grafting Surgery: An ISMICS Systematic Review and Consensus Conference Statements.

OBJECTIVE: The purpose of this consensus conference was to develop and update evidence-informed consensus statements and recommendations on harvesting saphenous vein and radial artery via an open as compared with endoscopic technique by systematically reviewing and performing a meta-analysis of randomized and nonrandomized clinical trials. METHODS: All randomized controlled trials and nonrandomized controlled trials included in the first the International Society for Minimally Invasive Cardiothoracic Surgery Consensus Conference and Statements, in 2005 up to November 30, 2015, were included in a systematic review and meta-analysis. Based on the resultant, 76 studies (23 randomized controlled trials and 53 nonrandomized controlled trials) on 281,459 patients analyzed, consensus statements, and recommendations were generated comparing the risks and benefits of endoscopic versus open conduit harvesting for patients undergoing coronary artery bypass grafting. RESULTS: Compared with open vein harvest, it is reasonable to perform endoscopic vein harvest of saphenous vein to reduce wound-related complications, postoperative length of stay, and outpatient wound management resources and to increase patient satisfaction (class I, level A). Based on the quality of the conduit and major adverse cardiac events as well as 6-month angiographic patency, endoscopic vein harvest was noninferior to open harvest. It is reasonable to perform endoscopic radial artery harvest to reduce wound-related complication and to increase patient satisfaction (class I, level B-R and B-NR, respectively) with reduction in major adverse cardiac events and noninferior patency rate at 1 and 3 to 5 years (class III, level B-R). CONCLUSIONS: Based on the consensus statements, the consensus panel recommends (class I, level B) that endoscopic saphenous vein and radial artery harvesting should be the standard of care for patients who require these conduits for coronary revascularization.

Outcome improvement and cost reduction in an increasingly morbid cardiac surgery population.

Two studies assessed initiatives to improve the quality and the cost-effectiveness of cardiac surgery. The first evaluated a system for access and stabilization (SAS), with coronary stabilization, and a clinical effectiveness quality initiative (CEQI) in off-pump coronary artery bypass grafting. The SAS + CEQI cohort showed significantly lower mortality, a lower percentage of patients requiring prolonged ventilation, and a shorter mean postoperative length of hospital stay than the pre-SAS cohort who underwent on-pump coronary artery bypass grafting. The second study assessed the potential for noninvasive cerebral oximetry to reduce strokes related to all cardiac surgery by optimizing cerebral oxygen delivery. The incidence of permanent stroke was significantly lower in the cerebral oximetry group than in an earlier control group in which cerebral oximetry was not used, despite the fact that the study group had a significantly greater number of patients in New York Heart Association classes III and IV. The proportion of patients requiring prolonged ventilation was significantly lower, and the length of postoperative hospital stay was significantly shorter in the study group than in the control group. The incidence of cerebrovascular accident in the study group was 0.97%, compared with 2.03% in the controls. This translated to a potential avoidance of 12 cerebrovascular accidents and approximately $254,214 in direct costs and more than $425,000 in total costs. The results show that specific measures can improve outcomes and reduce costs in cardiac surgery. Therefore, the use of a clinical effectiveness quality initiative and cerebral oximetry in all cardiac surgery, with the SAS system for off-pump surgery, should be advocated.

The Thoratec Implantable Ventricular Assist Device (IVAD): initial clinical experience.

BACKGROUND: The Thoratec Implantable Ventricular Assist Device (IVAD) is the only FDA-approved intracorporeal biventricular cardiac assist device. It is a titanium-coated version of its predecessor, the Paracorporeal Ventricular Assist Device (PVAD). The blood pump is compatible with the portable TLC-II driver, making home discharge feasible. METHODS: Nine consecutive patients were implanted with the IVAD from June 2005 through March 2006. The indications for support were acute heart failure in 6 cases and chronic heart failure in 3 cases. All patients were managed with maximal medical therapies including intravenous inotropic drugs prior to implant. RESULTS: All patients survived the surgical implant. Six patients were considered successful: 3 patients discharged to home and subsequently received transplantation, 2 are awaiting transplantation (1 at home and 1 in-house), and 1 patient was successfully explanted. Three patients expired postoperatively because of multiple organ system failure (2 patients) and pulmonary hemorrhage (1 patient). There were no device malfunctions. There was 1 localized driveline site infection and 1 thromboembolic event with partial visual loss. CONCLUSIONS: The IVAD is a unique device capable of providing uni- or bi-ventricular support for either acute or chronic heart failure conditions. Its versatility permits bridge to transplant or recovery options. Home discharge is feasible.

Patterns of secondary prevention in older patients undergoing coronary artery bypass grafting during hospitalization for acute myocardial infarction.

BACKGROUND: Aggressive risk factor modification decreases cardiovascular events and mortality in patients after coronary artery bypass grafting (CABG). Little is known regarding the use of secondary prevention in older patients undergoing CABG during hospitalization for acute myocardial infarction (AMI). METHODS AND RESULTS: Medical records were reviewed for a sample of 37,513 patients hospitalized with AMI in the United States between April 1998 and March 1999. Patients >or=65 years of age who underwent CABG after AMI (n=2,267 [8%]) were evaluated for the prescription of 4 therapies at discharge: aspirin, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, and lipid lowering, in eligible patients without contraindications to therapy and compared with patients who did not undergo CABG (n=26,484 [92%]). Patients undergoing CABG had higher rates of aspirin than patients who did not undergo CABG (88.0% versus 83.2%, P=0.0002). However, CABG patients were less likely to receive beta-blockers (61.5% versus 72.1%, P<0.0001), ACE inhibitors (55.5% versus 72.1%, P<0.0001), or lipid lowering (34.7% versus 55.7%, P<0.0001) prescriptions than patients who did not undergo CABG. After adjustment for disease severity, patients undergoing CABG were no longer more likely to receive discharge aspirin, and the magnitude of other differences in care increased. CONCLUSIONS: Evidence-based discharge therapies are underutilized in older patients who underwent CABG during hospitalization for AMI. Although national efforts focusing on improving short-term surgical mortality have been successful, strategies should be developed to increase the utilization of therapies known to improve long-term mortality in patients undergoing CABG.

ISMICS Consensus Conference and Statements of Randomized Controlled Trials of Off-Pump Versus Conventional Coronary Artery Bypass Surgery.

OBJECTIVE: At this consensus conference, we developed evidence-informed consensus statements and recommendations on the practice of off-pump coronary artery bypass graft (OPCAB) by systematically reviewing and performing meta-analysis of the randomized controlled trials (RCTs) comparing OPCAB and conventional coronary artery bypass (CCAB). METHODS: All RCTs of OPCAB versus CCAB through April 2013 were screened, and 102 relevant RCTs (19,101 patients) were included in a systematic review and meta-analysis (15 RCTs of 9551 high-risk patients; and 87 RCTs of 9550 low-risk patients) in accordance with the Cochrane Collaboration and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methodology. Consensus statements for the risks and benefits of OPCAB surgery in mortality, morbidity, and resource use were developed based on best available evidence. RESULTS: Compared to CCAB, it is reasonable to perform OPCAB to reduce risks of stroke [class IIa, level of evidence (LOE) A], renal dysfunction/failure (class IIa, LOE A), blood transfusion (class I, LOE A), respiratory failure (class I, LOE A), atrial fibrillation (class I, LOE A), wound infection (class I, LOE A), ventilation time, and ICU and hospital length of stay (class I, LOE A). However, OPCAB may be associated with a reduced number of grafts performed (class I, LOE A) and with diminished graft patency (class IIa, LOE A, with increased coronary reintervention at 1 year and beyond (class IIa, LOE A), as well as increased mortality at a median follow-up of 5 years (class IIb, LOE A). CONCLUSIONS: OPCAB compared with CCAB may improve outcomes in the short-term (stroke, renal dysfunction, blood transfusion, respiratory failure, atrial fibrillation, wound infection, ventilation time, and length of stay). However, over the longer-term, OPCAB may be associated with reduced graft patency, and increased risk of cardiac re-intervention and death.

Three dimensional reconstruction of CT scan images to aid the cardiac surgeon.

Minimally invasive techniques and approaches have the potential advantages of less operative stress and healthcare resource utilization but at the "cost" of less operative field of view. Newer imaging techniques utilizing three dimensional reconstruction of computed tomography scan images (3DCT) can aid the cardiac surgeon in visualizing the geometric relationships to plan and execute complex surgical procedures via minimally invasive or standard approaches. Multidetector-row CT scanning and post-processing yield these 3DCT images. We describe representative examples of this imaging technology in planning complex surgical procedures. Vascular structures, pulmonary and atrial venous relationships and cardiac ventricular functional anatomy are all visualized. Utilizing advances in imaging should allow surgeons to rapidly adopt newer technologies and minimally invasive techniques.

Optimizing intraoperative cerebral oxygen delivery using noninvasive cerebral oximetry decreases the incidence of stroke for cardiac surgical patients.

BACKGROUND: A recent study demonstrated that almost 75% of strokes after coronary artery revascularization surgery occur in patients classified preoperatively as low to medium risk. Thus, despite the use of risk classification, most strokes can occur when not expected. We hypothesized that optimization of cerebral oxygen delivery variables by using noninvasive cerebral oximetry could reduce the incidence of stroke. METHODS: Cerebral oximetry was used by all surgeons to monitor cerebral oxygen saturation in all cardiac surgery patients from January 1, 2002, until June 30, 2003 (n = 1034; 18 months, treatment group). Cerebral oxygen delivery was optimized during surgery by modifying oxygen delivery and consumption variables to maintain oximetry values at or near the patient's preinduction baseline. Stroke was defined according to guidelines of the Society of Thoracic Surgeons. The incidence of stroke in the treatment group was compared with that for patients who underwent cardiac surgery between July 1, 2000, and December 31, 2001, (n = 1245; 18 months, control group) before cerebral oximetry was incorporated. RESULTS: Age and sex distribution were similar in the 2 groups. The study group had significantly more patients in New York Heart Association (NYHA) classes III and IV than the control group, and patients in the study group were sicker overall. Despite this difference, the study group overall had fewer permanent strokes (10 [0.97%] versus 25 [2.5%]; P < .044). This difference remained significant when the results were controlled for NYHA class and on-pump or off-pump surgery. When the patients were examined by NYHA class, the proportion of patients requiring prolonged ventilation was significantly smaller in the study group (6.8% versus 10.6%; P < .0014), as was the length of hospital stay (P < .046). CONCLUSIONS: The treatment group, which underwent all cardiac surgeries with optimized cerebral oxygen delivery using cerebral oximetry monitoring, demonstrated a significantly lower incidence of permanent stroke. Because our study is retrospective, a prospective randomized trial is warranted.

Mitroflow aortic bioprosthesis 5-year follow-up: north american prospective multicenter study.

BACKGROUND: The Mitroflow valve (Sorin Group, Milan, Italy) has been in use since 1982 and has shown long-term durability in large studies from European centers but has not been studied for long-term hemodynamics in large standardized multicenter trials. This study sought to assess the hemodynamics of the Mitroflow valve by extending the duration of follow-up in an ongoing prospective multicenter trial conducted in North America. METHODS: Six sites participated in this midterm study requiring annual follow-up and echocardiographic evaluation using a standardized transthoracic echocardiography acquisition protocol. RESULTS: There were 276 patients enrolled (age 74±8 years) and 54% were in New York Heart Association (NYHA) functional class III-IV. Follow-up from the time of valve implantation had a mean of 4.0±1.7 years with a cumulative follow-up of 1,102 patient-years. At 5 years of follow-up, 99% of patients were free of moderate or severe aortic regurgitation and 94% were in NYHA functional class I or II. Between baseline and 5 years, mean gradients increased an average of 0.4 to 4.3 mm Hg. The change in effective orifice area was appreciably small (-0.1 to -0.3 cm2) after 5 years. There were 57 deaths (4 early and 53 late) and 9 valve explants. CONCLUSIONS: The Mitroflow valve implanted in the aortic position has shown to be hemodynamically stable over a 5-year follow-up in an elderly population with a high prevalence of comorbid conditions.