Sutureless Versus Rapid Deployment Aortic Valve Replacement: Results From a Multicenter Registry.

BACKGROUND: This study compared clinical and hemodynamic in-hospital outcomes of patients undergoing sutureless vs rapid deployment aortic valve replacement (SURD-AVR) in the large population of the Sutureless and Rapid Deployment International Registry (SURD-IR). METHODS: We examined 4695 patients who underwent isolated or combined SURD-AVR. The "sutureless" Perceval valve (LivaNova PLC, London, United Kingdom) was used in 3133 patients and the "rapid deployment" Intuity (Edwards Lifesciences, Irvine, CA) in 1562. Potential confounding factors were addressed by the use of propensity score matching. After matching, 2 well-balanced cohorts of 823 pairs (isolated SURD-AVR) and 467 pairs (combined SURD-AVR) were created. RESULTS: Patients who received Perceval and Intuity valves showed similar in-hospital mortality and rate of major postoperative complications. Perceval was associated shorter cross-clamp and cardiopulmonary bypass times. In the isolated SURD-AVR group, patients receiving Perceval were more likely to undergo anterior right thoracotomy incision. Postoperative transvalvular gradients were significantly lower for the Intuity valve compared with those of the Perceval valve, either in isolated and combined SURD-AVR. The Intuity valve was associated with a lower rate of postoperative mild aortic regurgitation. CONCLUSIONS: Our results confirm the safety and efficacy of SURD-AVR regardless of the valve type. The Perceval valve was associated with reduced operative times and increased anterior right thoracotomy incision. The Intuity valve showed superior hemodynamic outcomes and a lower incidence of postoperative mild aortic regurgitation.

Cardiac surgery practice during the COVID-19 outbreak: a multicentre national survey.

OBJECTIVES: Healthcare systems worldwide have been overburdened by the coronavirus disease 2019 (COVID-19) outbreak. Accordingly, hospitals had to implement strategies to profoundly reshape both non-COVID-19 medical care and surgical activities. Knowledge about the impact of the COVID-19 pandemic on cardiac surgery practice is pivotal. The goal of the present study was to describe the changes in cardiac surgery practices during the health emergency at the national level. METHODS: A 26-question web-enabled survey including all adult cardiac surgery units in Italy was conducted to assess how their clinical practice changed during the national lockdown. Data were compared to data from the corresponding period in 2019. RESULTS: All but 2 centres (94.9%) adopted specific protocols to screen patients and personnel. A significant reduction in the number of dedicated cardiac intensive care unit beds (-35.4%) and operating rooms (-29.2%), along with healthcare personnel reallocation to COVID departments (nurses -15.4%, anaesthesiologists -7.7%), was noted. Overall adult cardiac surgery volumes were dramatically reduced (1734 procedures vs 3447; P < 0.001), with a significant drop in elective procedures [580 (33.4%) vs 2420 (70.2%)]. CONCLUSIONS: This national survey found major changes in cardiac surgery practice as a response to the COVID-19 pandemic. This experience should lead to the development of permanent systems-based plans to face possible future pandemics. These data may effectively help policy decision-making in prioritizing healthcare resource reallocation during the ongoing pandemic and once the healthcare emergency is over.

Minimally Invasive vs Conventional Aortic Valve Replacement With Rapid-Deployment Bioprostheses.

BACKGROUND: The aim of this multicenter retrospective study was to compare early and midterm clinical and hemodynamic results of aortic valve replacement with rapid-deployment bioprostheses performed through conventional full-sternotomy vs mini-sternotomy. METHODS: Data from the Italian multicenter registry of aortic valve replacement with rapid-deployment bioprostheses (INTU-ITA registry) were analyzed. Patients were divided into 2 groups: full sternotomy (FS) and ministernotomy (MS). Primary endpoint was the comparison of early and midterm mortality. Secondary endpoints were: comparison of intraoperative variables, complications, and hemodynamic performance. A propensity score weighting approach was used for data analysis. RESULTS: A total of 1057 patients were analyzed: 435 (41.2%) and 622 (58.8%) in group FS and MS, respectively. Thirty-day mortality was 1.6% and 0.6% in FS and MS groups, respectively (P = .074). cardiopulmonary bypass time was 78.5 minutes and 83 minutes in FS and MS groups, respectively (P = .414). In the overall cohort, the incidence of intraoperative complications and of device success was 3.8% (40 patients) and 95.9% (1014 patients), respectively, with no significant differences between groups. Survival at 1, 3, and 5 years was 94.1%, 98.1%, 88.5% and 91.8%, 85.2%, and 84.8% in FS and MS groups, respectively (P = .412). The 2 groups showed similar postoperative gradients (median mean gradient, FS: 10.0 mm Hg, MS: 11.0 mm Hg; P = .170) and also similar incidence of patient-prosthesis mismatch (FS: 7%, MS: 6.4%, P = .647). CONCLUSIONS: According to our data, rapid-deployment bioprostheses allow the performance of minimally invasive aortic valve replacement with similar surgical times and similar clinical and hemodynamic outcomes to conventional surgery and should be considered the first choice in these procedures.

Sutureless and rapid deployment implantation in bicuspid aortic valve: results from the sutureless and rapid-deployment aortic valve replacement international registry.

BACKGROUND: Benefits of sutureless and rapid deployment (SURD) bioprostheses in bicuspid aortic valves (BAV) are controversial. The aim of this study is to report the outcomes of patients undergoing aortic valve replacement (AVR) for BAV from the Sutureless and Rapid-Deployment Aortic Valve Replacement International Registry (SURD-IR). METHODS: Of the 4,636 patients who received primary isolated SURD-AVR between 2007 and 2018, 191 (4.1%) BAV patients underwent AVR with SURD valve. RESULTS: Overall 30-day mortality was 1.6%. The Intuity valve was implanted in 53.9% of cases, whereas the Perceval was implanted in 46.1%. Rate of stroke for isolated AVR was 4.2%. No case of endocarditis, thromboembolism, myocardial infarction, valve dislocation or structural valve deterioration was reported in the early phase. Rate of pacemaker implantation and moderate-severe aortic regurgitation (AR) were 7.9% and 3.7%, respectively. CONCLUSIONS: BAV is not considered a contraindication for the implantation of SURD valves. However, detailed information of aortic root geometry as well as the knowledge of some technical considerations are mandatory for a good outcome.

Minimally invasive access type related to outcomes of sutureless and rapid deployment valves.

OBJECTIVES: Minimally invasive surgical techniques with optimal outcomes are of paramount importance. Sutureless and rapid deployment aortic valves are increasingly implanted via minimally invasive approaches. We aimed to analyse the procedural outcomes of a full sternotomy (FS) compared with those of minimally invasive cardiac surgery (MICS) and further assess MICS, namely ministernotomy (MS) and anterior right thoracotomy (ART). METHODS: We selected all isolated aortic valve replacements in the Sutureless and Rapid Deployment Aortic Valve Replacement International Registry (SURD-IR, n = 2257) and performed propensity score matching to compare aortic valve replacement through FS or MICS (n = 508/group) as well as through MS and ART accesses (n = 569/group). RESULTS: Postoperative mortality was 1.6% in FS and MICS patients who had a mean logistic EuroSCORE of 11%. Cross-clamp and cardiopulmonary bypass (CPB) times were shorter in the FS group than in the MICS group (mean difference 3.2 and 9.2 min; P < 0.001). Patients undergoing FS had a higher rate of acute kidney injury (5.6% vs 2.8%; P = 0.012). Direct comparison of MS and ART revealed longer mean cross-clamp and CPB times (12 and 16.7 min) in the ART group (P < 0.001). The postoperative outcome revealed a higher stroke rate (3.2% vs 1.2%; P = 0.043) as well as a longer postoperative intensive care unit [2 (1-3) vs 1 (1-3) days; P = 0.009] and hospital stay [11 (8-16) vs 8 (7-12) days; P < 0.001] in the MS group than in the ART group. CONCLUSIONS: According to this non-randomized international registry, FS resulted in a higher rate of acute kidney injury. The ART access showed a lower stroke rate than MS and a shorter hospital stay than all other accesses. All these findings may be related to underlying patient risk factors.

Current trends of sutureless and rapid deployment valves: an 11-year experience from the Sutureless and Rapid Deployment International Registry.

OBJECTIVES: Current evidence on sutureless and rapid deployment aortic valve replacement (SURD-AVR) is limited and does not allow for the assessment of the clinical impact and the evolution of procedural and clinical outcomes of this new valve technology. The Sutureless and Rapid Deployment International Registry (SURD-IR) represents a unique opportunity to evaluate the current trends and outcomes of SURD-AVR interventions. METHODS: Data from 3682 patients enrolled between 2007 and 2018 were analysed. Patients were divided according to the date of surgery into 6 equal groups and by the type of intervention: isolated SURD-AVR (n = 2472) and combined SURD-AVR (n = 1086). RESULTS: Across the 11-year study period, significant changes occurred in patient characteristics including a decrease in age and in estimated surgical risk. Less invasive approaches for isolated SURD-AVR increased considerably from 49.4% to 85.5%. The overall in-hospital mortality rate was 1.6% and 3.9% in isolated and combined procedures, respectively, with no change over time. The rate of perioperative stroke decreased significantly (from 4% to 0.5%), as did the rates of postoperative pacemaker implantation (from 12.8% to 5.9%) and aortic regurgitation (from 17.8% to 2.7%). CONCLUSIONS: The present study provides a comprehensive analysis of the current trends and results of SURD-AVR interventions. The most notable changes over time were the increasing implantation of SURD valves in a younger population, with more frequent utilization of less invasive techniques. SURD-AVR demonstrated remarkable improvements in clinical outcomes with a significant reduction in the rates of stroke, pacemaker implantation and postoperative aortic regurgitation.

Minimally Invasive Redo Aortic Valve Replacement: Results From a Multicentric Registry (SURD-IR).

BACKGROUND: Reoperation for aortic valve replacement can be challenging and is usually associated with an increased risk for complications and mortality. The study aim was to report the results of a multicenter cohort of patients who underwent minimally invasive reoperative aortic valve replacement with a sutureless or rapid-deployment prosthesis. METHODS: From 2007 to 2018 data from 3651 patients were retrospectively collected from the Sutureless and Rapid-Deployment Aortic Valve Replacement International Registry. Of them, 63 patients who had previously undergone cardiac surgery represented the study population. In-hospital clinical and echocardiographic outcomes were recorded. RESULTS: Mean age of the selected 63 patients was 75.3 ± 7.8 years and logistic EuroSCORE 10.1. Surgery was performed by ministernotomy in 43 patients (68.3%) and by anterior right thoracotomy in 20 (31.7%); 31 patients (49.2%) received the Perceval valve (Livanova PLC, London, UK) and 32 (50.8%) the Intuity valve (Edwards Lifesciences, Irvine, CA). Mean cross-clamp time was 57.8 ± 23.2 minutes and cardiopulmonary bypass time 95.0 ± 34.3 minutes. Neither conversion to full sternotomy nor in-hospital deaths occurred. Postoperative events were ischemic cerebral events in 3 patients (4.8%), need for pacemaker implantation in 2 (3.6%), bleeding requiring reoperation in 5 (8.9%), and dialysis in 1 (1.6%). Median intensive care unit stay was 1 day, and median length of hospital stay was 10 days. On echocardiographic evaluation 1 patient showed a significant postoperative aortic regurgitation. CONCLUSIONS: Minimally invasive reoperative aortic valve replacement with a sutureless or rapid-deployment prosthesis is a safe and feasible treatment strategy, resulting in fast recovery and improved postoperative outcome with no mortality and an acceptable complication rate.

Mitral Valve Replacement With a Third-Generation Porcine Valve: An Italian Multicentered Study.

BACKGROUND: Postoperative outcomes of a third-generation porcine bioprosthesis for mitral valve replacement (MVR) have been poorly addressed. The objective of this study was to perform an independent, retrospective, multicenter study on outcomes of patients undergoing MVR with a Mosaic (Medtronic Inc, Minneapolis, MN) porcine bioprosthesis. METHODS: From 1998 to 2011, 805 patients underwent MVR with a Mosaic porcine valve in 11 cardiac centers. There were 465 female patients (58%), and the overall mean age was 73.5 ± 7 years. Associated procedures included coronary artery bypass grafting (201 patients; 24.9%), aortic valve replacement (152 patients; 18.9%), tricuspid annuloplasty (187 patients; 22.3%), and other cardiac procedures (116 patients; 14.4%). RESULTS: Median follow-up was 44 months (interquartile range, 16 to 63), with a cumulative duration of 2.769 patient-years. Early mortality for isolated elective MVR was 3.8% (12 of 313), and overall early mortality was 7.8% (n = 63). The rate of late mortality was 3.4%/patient-year (95 late deaths). At 10 years, overall survival was 57.4% (95% confidence interval [CI], 48.8% to 67.5%), and cumulative rates of cardiac- and valve-related death were 7.4% (95% CI, 4.8% to 10.1%) and 1.1% (95% CI, 0.2% to 1.9%), respectively. The 10-year cumulative rates of thromboembolic and hemorrhagic events were 6.6% (95% CI, 1.4% to 11.8%) and 3.9% (95% CI, 0.1% to 8%), respectively, and the 10-year cumulative incidence of prosthetic valve endocarditis was 3% (95% CI, 1.2% to 4.9%). Finally, the 10-year cumulative incidences of structural valve degeneration and reoperations were 5.8% (95% CI, 0.2% to 11.5%) and 4.8% (95% CI, 0.7% to 10.3%), respectively. CONCLUSIONS: This independent, multicenter, retrospective study indicated that the Mosaic porcine bioprosthesis for MVR provides satisfactory results in terms of both early and long-term outcomes up to 14 years from its implantation.

Carpal Tunnel Syndrome: Diagnostic Usefulness of Ultrasound Measurement of the Median Nerve Area and Quantitative Elastographic Measurement of the Median Nerve Stiffness.

OBJECTIVES: To correlate the ultrasound (US) measurements of the median nerve cross-sectional area (CSA) and the measurements of its stiffness by shear wave elastography (SWE) with the severity grade of carpal tunnel syndrome (CTS) using electrodiagnostic testing (EDT) and to determine the cutoff points for CSA and SWE measurements to allow us to discriminate patients with moderate and severe CTS from those with mild or negative EDT findings. METHODS: Seventy-three patients with 105 hands with a clinical suspicion of CTS were studied with US and SWE. We measured the median nerve CSA and elasticity (E) at the tunnel inlet (CSAu and Eu), in the quadratus pronator (CSAo and Eo), and the differences (CSAu - CSAo and Eu - Eo). RESULTS: The nerve area and stiffness increased according to the EDT severity of CTS; the CSA increased proportionally as CTS increased from negative to severe according to EDT, and the stiffness was not different between patients with negative and mild EDT findings but was higher in patients with moderate and severe EDT findings versus negative and mild EDT findings. The cutoff points of a CSAu of 14 mm2 or greater and an Eu - Eo of 57 kPa or greater together allowed the discrimination of moderate and severe CTS from the rest. CONCLUSIONS: The joint use of US and SWE is an alternative to EDT in the clinical management and treatment of patients with a clinical suspicion of CTS.

Minimally invasive aortic valve replacement with sutureless and rapid deployment valves: a report from an international registry (Sutureless and Rapid Deployment International Registry)†.

OBJECTIVES: The impact of sutureless and rapid deployment (SURD) valves on the clinical outcomes of patients undergoing minimally invasive aortic valve replacement (MI-AVR) has still to be defined. The aim of this study was to assess clinical characteristics and in-hospital results of patients receiving SURD-AVR through less invasive approaches in the large population of the Sutureless and Rapid Deployment International Registry (SURD-IR). METHODS: Of the 1935 patients who received primary isolated SURD-AVR between 2009 and 2018, a total of 1418 (73.3%) underwent MI interventions and were included in this analysis. SURD-AVR was performed using upper ministernotomy in 56.4% (n = 800) of cases and anterior right thoracotomy in 43.6% (n = 618). Perceval S was implanted in 1011 (71.3%) patients and Edwards Intuity or Intuity Elite in 407 (28.7%) patients. RESULTS: Overall in-hospital mortality and stroke rates were 1.7% and 2%, respectively. A definitive pacemaker implantation was reported in 9% of cases and significantly decreased over the observational period, from 20.6% to 5.6% (P = 0.002). The Perceval valve was associated with shorter operative times and was more frequently implanted in patients receiving anterior right thoracotomy incision. The Intuity valve was preferred in younger patients and revealed superior postoperative haemodynamic results. CONCLUSIONS: SURD-AVR was largely performed through less invasive approaches and can be considered as a primary indication in MI surgery. In the SURD-IR cohort, MI SURD-AVR using both Perceval and Intuity valves appeared a safe and reproducible procedure associated with promising early results.

Operative outcome of patients at low, intermediate, high and 'very high' surgical risk undergoing isolated aortic valve replacement with sutureless and rapid deployment prostheses: results of the SURD-IR registry.

OBJECTIVES: The ideal strategy for the treatment of severe aortic valve stenosis in patients of varying risk categories has become a debated topic in the last years: should the transcatheter or surgical approach be adopted? The aim of this study was to evaluate the outcomes of low-, intermediate-, high- and very high-risk patients undergoing sutureless, rapid deployment aortic valve replacement. METHODS: From 2007 to 2017, data on a total of 3651 patients were collected from the Sutureless and Rapid Deployment Aortic Valve Replacement International Registry (SURD-IR). Of these, 2057 patients who underwent primary isolated aortic valve replacement were considered for this analysis and classified as being at low (EuroSCORE <5; n = 500), intermediate (EuroSCORE 5-10; n = 901), high (EuroSCORE 11-20; n = 500) and very high (EuroSCORE >20; n = 156) preoperative risk. RESULTS: Overall, a less invasive approach was used in 74.1% of patients and represented the most frequent (>50%) approach in all risk categories. The Perceval prosthesis was used more frequently than other devices, especially in patients at high and very high risk. Hospital mortality was 1.6%, 0.8%, 1.9% and 2.7% in low-, intermediate-, high- and very high-risk patients, respectively, with no significant differences among subgroups. Similarly, postoperative complication rates were similar across the different risk categories. CONCLUSIONS: Surgical aortic valve replacement using sutureless, rapid deployment biological valve prostheses is associated with excellent results and represents a safe and effective treatment option for patients with severe aortic valve stenosis. This seems to be particularly true in patients with a higher risk profile.

Sutureless and Rapid-Deployment Aortic Valve Replacement International Registry (SURD-IR): early results from 3343 patients.

OBJECTIVES: The Sutureless and Rapid-Deployment Aortic Valve Replacement International Registry (SURD-IR) was established by a consortium of 18 research centres-the International Valvular Surgery Study Group (IVSSG)-to overcome limitations of the literature and provide adequately powered evidence on sutureless and rapid-deployment aortic valves replacement (SURD-AVR). METHODS: Data from 3343 patients undergoing SURD-AVR over a 10-year period (2007-2017) were collected in the registry. The mean age of the patients was 76.8 ± 6.7 years, with 36.4% being 80 years or older. The average logistic EuroSCORE was 11.3 ± 9.7%. RESULTS: Isolated SURD-AVR was performed in 70.7% (n = 2362) of patients using full sternotomy (35.3%) or less invasive approaches (64.8%). Overall hospital mortality was 2.1%, being 1.4% in patients who had isolated SURD-AVR and 3.5% in those who had concomitant procedures (P < 0.001). When considering baseline risk profile, mortality rate was 0.8% and 1.9% in low risk (logistic EuroSCORE <10%) isolated SURD-AVR and combined SURD-AVR, respectively, and 2.2% and 3.7% in higher risk patients (logistic EuroSCORE ≥10%). Postoperative neurological complications included stroke (2.8%) and transient ischaemic attack (1.1%). New atrioventricular block requiring pacemaker occurred in 10.4% of the patients. The rate of pacemaker implantation significantly decreased over time [from 17.2% (2007-2008) to 5.4% (2016); P = 0.02]. CONCLUSIONS: Our findings showed that SURD-AVR is a safe and effective alternative to conventional aortic valve replacement and is associated with excellent clinical outcomes. Further adequately powered statistical analyses from the retrospective and prospective SURD-IR will allow for the development of high-quality evidence-based clinical guidelines for SURD-AVR.

Does pre-existing aortic regurgitation protect from death in patients who develop paravalvular leak after TAVI?

OBJECTIVE: The aim of this study was to investigate interactions among pre-procedural aortic regurgitation (AR), post-procedural paravalvular leak (PVL) and long-term clinical outcomes. METHODS AND RESULTS: We analyzed data prospectively collected in the Italian Transcatheter balloon-Expandable Registry (ITER) on aortic stenosis (AS) patients. The degree of pre-procedural AR and post-procedural PVL was stratified as: absent/trivial, mild, and moderate/severe. VARC definitions were applied to outcomes. Of 1708 patients, preoperatively, AR was absent/trivial in 40% of the patients, mild in 42%, and moderate in 18%. Postoperatively, PVL was moderate-severe in 5%, mild in 32% of patients, and absent/trivial in 63%. Clinical follow-up, median 821days (IQR 585.75), was performed in 99.7% of patients. PVL, but not preoperative AR, was a major predictor of adverse outcome (HR 1.33, CI 95% 0.9-2.05, p=0.012 for mild PVL, HR 1.36, CI 95% 0.9-2.05, p<0.001 for PVL≥moderate and OR 1.04, p=0.97 respectively). Patients with moderate-severe PVL and preoperative left ventricle (LV) dilatation (LVEDVi>75ml/m2) showed better survival than those without dilatation (HR 8.63, p=0.001). CONCLUSIONS: In patients with severe AS treated with balloon-expandable TAVI, the presence of PVL, but not pre-procedural AR, was a major predictor of adverse outcome. Preoperative LV dilatation seemed to offer some clinical advantages.

Incremental value of anemia in cardiac surgical risk prediction with the European System for Cardiac Operative Risk Evaluation (EuroSCORE) II model.

BACKGROUND: Anemia is a risk factor for adverse events after cardiac operations. We evaluated the incremental value of preoperative anemia over the European System for Cardiac Operative Risk Evaluation (EuroSCORE) II to predict hospital death after cardiac operations. METHODS: Data for 4,594 consecutive adults (1,548 women [33.7%]), aged 67 ± 11 years, who underwent cardiac operations from January 2011 to July 2013 were extracted from the Regional Cardiac Surgery Registry of Puglia. The last preoperative hemoglobin value was used, according to World Health Organization criteria, to classify anemia as mild (hemoglobin 11.0 to 12.9 g/dL in men and 11.0 to 11.9 g/dL in women) in 1,021 patients (22.2%) and as moderate to severe (hemoglobin <11.0 g/dL) in 593 patients (12.9%). The EuroSCORE II was used to evaluate predicted hospital death after operations. Logistic regression analysis for in-hospital death was performed including EuroSCORE II risk factors and anemia, with model discrimination quantified by C statistic and risk classification by the use of net reclassification improvement (NRI). RESULTS: Overall expected and observed mortality rates were 4.4% and 5.9%. Anemia was significantly associated with a mortality rate of 3.4% in patients without anemia, 7.7% in mild anemia, and 15.7% in moderate to severe anemia (p < 0.001) and also at multivariate analysis correcting for EuroSCORE II (p < 0.001). When anemia was analyzed with EuroSCORE II, the model improved in discrimination (C statistic = 0.852 vs 0.860; p = 0.007) and reclassification (category free-NRI, 0.592; p < 0.001), preserving the calibration with good concordance between predicted probabilities and outcome. CONCLUSIONS: Preoperative anemia has strong association with operative death in cardiac surgical patients. Anemia provides significant incremental value over the EuroSCORE II and should be considered for assessment of cardiac surgical risk.

Development and results of Puglia adult cardiac surgery registry.

AIMS: To evaluate the feasibility of a cardiac surgery registry and to describe patients' characteristics, type of procedures performed, incidence of postoperative complications with short and middle-term mortality. METHODS: A database with clinical information and details on cardiac surgical operations was implemented by Puglia Health Regional Agency to collect data of each cardiac surgery procedure performed in the seven adult cardiac surgery centres of the region. Health regional agency personnel guaranteed data accuracy and quality control procedures. Mortality after the discharge was evaluated for residents in Puglia by linking clinical data to the Health Information System. RESULTS: From January 2011 to December 2012, 6429 operations were performed. All operations were included in the registry with very high completeness of collected data (95.3% per patient). The majority of the operations performed were coronary artery bypass graft alone (41.1%), valve surgery alone (26.2%), coronary artery bypass graft and valve surgery (11.4%), or valve with other surgery (11.8%). During a median follow-up of 12 months (interquartile range 6-18 months), 211 deaths were detected after the discharge. Overall, cumulative mortality from the operation was 8.2% at 6 months and 9.5% at 12 months. CONCLUSION: Implementation of a regional clinical registry of cardiac surgery is feasible with a great level of accuracy and the evaluation of mid-term mortality overcomes the limited value of hospital mortality. An accurate cardiac surgery registry elicits epidemiologic evaluations, comparisons between expected and observed mortality, incidence of postoperative complications and encourages a reliable public reporting.

Myocardial damage influences short- and mid-term survival after valve surgery: a prospective multicenter study.

OBJECTIVE: Myocardial damage occurs after valve surgery, but its prognostic implication has not been evaluated. The aim of the present study was to assess the influence of myocardial damage on mortality and morbidity in patients undergoing aortic surgery (AVS) and mitral valve surgery (MVS). METHODS: In a prospective multicenter study from the cardiac surgery registry of the Puglia region, cardiac troponin I (cTnI) was measured immediately after and the morning after the intervention in consecutive patients undergoing AVS or MVS. The percentile ranks of the cTnI peak values within each center were analyzed. RESULTS: Of 965 patients (age, 67±12 years; 45.5% women), 579 had undergone AVS and 386 MVS. cTnI release was significantly greater in the MVS group than in the AVS group and in the nonsurvivors than in the survivors in both groups. The cTnI cutoff with the greatest sensitivity and specificity (60th percentile for AVS and 91st for MVS) in predicting hospital mortality (2.6%) was also associated with a greater rate of postoperative complications and mortality within 3 months postoperatively (multivariate hazard ratio, 3.38; P=.005). Compared with the reference model, which included the multivariate predictors of hospital mortality (active endocarditis, New York Heart Association class III-IV, left ventricular ejection fraction≤30%, and cardiopulmonary bypass duration), the addition of cTnI greater than the cutoffs showed significant improvement in model performance (likelihood ratio test, P=.009; net reclassification improvement, 0.751; P<.001; integrated discrimination improvement, 0.048; P=.002; c-index 0.832 vs 0.838). CONCLUSIONS: An elevated postoperative cTnI level was an independent risk factor for mortality and morbidity. Measurement of the cTnI level improved the risk reclassification of patients undergoing AVS or MVS.

Comparative application of multivariate models developed in Italy and Europe to predict early (28 days) and late (1 year) postoperative death after on- or off-pump coronary artery bypass grafting.

OBJECTIVES: The aim of this study was to compare the risk of death predictive performances of the OP-RISK, EuroSCORE, and Italian coronary artery bypass grafting (CABG) Outcome studies' functions when applied to a southern Italian cardiac surgery center (Sant'Anna hospital in Catanzaro [SAHCZ]), which contributed data to the Italian CABG Outcome study, and to see if this predictive index may be applied to on- and off-pump interventions. METHODS: The OP-RISK study data set was used to derive Weibull and logistic functions to predict early (28 days) and late (1 year) death rates following CABG based on ejection fraction, heart rate, age, and aortic cross-clamping time. Then the data of 385 CABG patients who underwent operations in 2003 in SAHCZ were collected with 1-year follow-up data, which also included data used to obtain EuroSCORE and Italian CABG Outcome study risk indices. RESULTS: Short- and long-term observed mortality rates after CABG were 2.59% and 5.88% in the SAHCZ series, largely dependent on whether CABG was alone (1.26% and 3.55%) or associated with ventriculoplasty (4.87% and 10.81%) or valve surgery (15.38% and 28.57%). There was a significant increasing trend (P = .002) of observed death rates in equinumeric tertiles of either OP-RISK (both Weibull and logistic) or EuroSCORE in the short term, whereas the trend was not significant for the Italian CABG Outcome study index. OP-RISK functions were significantly predictive for the long term (P < .005), as well as when only ejection fraction, heart rate, and age were considered (P < .011). CONCLUSIONS: It is essential to use clinical data following CABG when outcome prediction is concerned. OP-RISK and EuroSCORE indices are equally predictive in our experience, and a statistically significant (P = 0.02) difference was observed with the Italian CABG Outcome study index, whose trend in tertiles of calculated risk was not apparent, which is unexpected and unexplained. OP-RISK functions were adequate for long-term prediction. Since aortic cross-clamping time may be absent from tested predictive functions (for both short and long term), off-pump CABG mortality may also be predicted as similar to on-pump intervention mortality.

Topical cooling for myocardial protection: the results of a prospective randomized study of the "shallow technique".

INTRODUCTION AND BACKGROUND: Respiratory distress following cardiac surgery is a troublesome complication. In several cases it is associated to cool-related phrenic nerve injury (PNI) after adoption of iced slush or hypothermic cardiopulmonary bypass. We compare two different strategies for myocardial protection: the "shallow technique" (ST) (dripping and prompt removal of cold saline solution from the epicardial surface) plus normothermic cardiopulmonary bypass, versus mild hypothermic cardiopulmonary bypass plus iced slush. METHODS: Two hundred forty-nine patients undergoing elective cardiac surgery were randomly assigned to receive either ST (Group A) or iced slush (Group B). Occurrence of postoperative PNI (abnormal diaphragmatic movement plus alteration of nerve conduction) was evaluated. Multivariate analysis was performed for identification of factors associated to PNI. Patients had a 6-month follow-up. RESULTS: PNI and failure of extubation occurred more frequently in Group B (p = 0.009 and p = 0.034, respectively), but there was no statistically significant difference in mean intensive care unit stay. Diabetes and the use of iced slush were independent predictors of phrenic dysfunction, while internal thoracic artery (ITA) harvest was a significant risk factor only among Group B patients. Abnormal diaphragmatic movement was persistent at 6 months only in 30% of Group B individuals who suffered this complication in the early postoperative. CONCLUSIONS: ST likely reduces the incidence of postoperative PNI and might be protective mainly in the event of ITA harvest. It should be considered as a valuable tool for myocardial protection protocols.