Routine Functional Testing or Standard Care in High-Risk Patients after PCI.

BACKGROUND: There are limited data from randomized trials to guide a specific follow-up surveillance approach after myocardial revascularization. Whether a follow-up strategy that includes routine functional testing improves clinical outcomes among high-risk patients who have undergone percutaneous coronary intervention (PCI) is uncertain. METHODS: We randomly assigned 1706 patients with high-risk anatomical or clinical characteristics who had undergone PCI to a follow-up strategy of routine functional testing (nuclear stress testing, exercise electrocardiography, or stress echocardiography) at 1 year after PCI or to standard care alone. The primary outcome was a composite of death from any cause, myocardial infarction, or hospitalization for unstable angina at 2 years. Key secondary outcomes included invasive coronary angiography and repeat revascularization. RESULTS: The mean age of the patients was 64.7 years, 21.0% had left main disease, 43.5% had bifurcation disease, 69.8% had multivessel disease, 70.1% had diffuse long lesions, 38.7% had diabetes, and 96.4% had been treated with drug-eluting stents. At 2 years, a primary-outcome event had occurred in 46 of 849 patients (Kaplan-Meier estimate, 5.5%) in the functional-testing group and in 51 of 857 (Kaplan-Meier estimate, 6.0%) in the standard-care group (hazard ratio, 0.90; 95% confidence interval [CI], 0.61 to 1.35; P = 0.62). There were no between-group differences with respect to the components of the primary outcome. At 2 years, 12.3% of the patients in the functional-testing group and 9.3% in the standard-care group had undergone invasive coronary angiography (difference, 2.99 percentage points; 95% CI, -0.01 to 5.99), and 8.1% and 5.8% of patients, respectively, had undergone repeat revascularization (difference, 2.23 percentage points; 95% CI, -0.22 to 4.68). CONCLUSIONS: Among high-risk patients who had undergone PCI, a follow-up strategy of routine functional testing, as compared with standard care alone, did not improve clinical outcomes at 2 years. (Funded by the CardioVascular Research Foundation and Daewoong Pharmaceutical; POST-PCI ClinicalTrials.gov number, NCT03217877.).

Routine stress testing in diabetic patients after percutaneous coronary intervention: the POST-PCI trial.

BACKGROUND AND AIMS: The optimal follow-up surveillance strategy for high-risk diabetic patients with had undergone percutaneous coronary intervention (PCI) remains unknown. METHODS: The POST-PCI (Pragmatic Trial Comparing Symptom-Oriented versus Routine Stress Testing in High-Risk Patients Undergoing Percutaneous Coronary Intervention) study was a randomized trial comparing a follow-up strategy of routine functional testing at 1 year vs. standard care alone after high-risk PCI. Randomization was stratified according to diabetes status. The primary outcome was a composite of death from any cause, myocardial infarction, or hospitalization for unstable angina at 2 years. RESULTS: Among 1706 randomized patients, participants with diabetes (n = 660, 38.7%) had more frequent comorbidities and a higher prevalence of complex anatomical or procedural characteristics than those without diabetes (n = 1046, 61.3%). Patients with diabetes had a 52% greater risk of primary composite events [hazard ratio (HR) 1.52; 95% confidence interval (CI) 1.02-2.27; P = .039]. The 2-year incidences of the primary composite outcome were similar between strategies of routine functional testing or standard care alone in diabetic patients (7.1% vs. 7.5%; HR 0.94; 95% CI 0.53-1.66; P = .82) and non-diabetic patients (4.6% vs. 5.1%; HR 0.89; 95% CI 0.51-1.55; P = .68) (interaction term for diabetes: P = .91). The incidences of invasive coronary angiography and repeat revascularization after 1 year were higher in the routine functional-testing group than the standard-care group irrespective of diabetes status. CONCLUSIONS: Despite being at higher risk for adverse clinical events, patients with diabetes who had undergone high-risk PCI did not derive incremental benefit from routine surveillance stress testing compared with standard care alone during follow-up.

Recent Outcomes of Surgical Redo Aortic Valve Replacement in Prosthetic Valve Failure.

BACKGROUND: As redo surgical aortic valve replacement (AVR) is relatively high risk, valve-in-valve transcatheter AVR has emerged as an alternative for failed prostheses. However, the majority of studies are outdated. This study assessed the current clinical outcomes of redo AVR. METHODS AND RESULTS: This study enrolled 324 patients who underwent redo AVR due to prosthetic valve failure from 2010 to 2021 in four tertiary centers. The primary outcome was operative mortality. The secondary outcomes were overall survival, cardiac death, and aortic valve-related events. Logistic regression analysis, clustered Cox proportional hazards models, and competing risk analysis were used to evaluate the independent risk factors. Redo AVR was performed in 242 patients without endocarditis and 82 patients with endocarditis. Overall operative mortality was 4.6% (15 deaths). Excluding patients with endocarditis, the operative mortality of redo AVR decreased to 2.5%. Multivariate analyses demonstrated that endocarditis (hazard ratio [HR]: 3.990, p = 0.014), longer cardiopulmonary bypass time (HR: 1.006, p = 0.037), and lower left ventricular ejection fraction (LVEF) (HR: 0.956, p = 0.034) were risk factors of operative mortality. Endocarditis and lower LVEF were independent predictors of overall survival. CONCLUSION: The relatively high risk of redo AVR was due to reoperation for prosthetic valve endocarditis. The outcomes of redo AVR for nonendocarditis are excellent. Our findings suggest that patients without endocarditis, especially with acceptable LVEF, can be treated safely with redo AVR.

Differences in Brain Metabolite Profiles Between Normothermia and Hypothermia.

BACKGROUND: This study evaluated the difference in brain metabolite profiles between normothermia and hypothermia reaching 25°C in humans in vivo. METHODS: Thirteen patients who underwent thoracic aorta surgery under moderate hypothermia were prospectively enrolled. Plasma samples were collected simultaneously from the arteries and veins to estimate metabolite uptake or release. Targeted metabolomics based on liquid chromatographic mass spectrometry and direct flow injection were performed, and changes in the profiles of respective metabolites from normothermia to hypothermia were compared. The ratios of metabolite concentrations in venous blood samples to those in arterial blood samples (V/A ratios) were calculated, and log2 transformation of the ratios [log2(V/A)] was performed for comparison between the temperature groups. RESULTS: Targeted metabolomics were performed for 140 metabolites, including 20 amino acids, 13 biogenic amines, 10 acylcarnitines, 82 glycerophospholipids, 14 sphingomyelins, and 1 hexose. Of the 140 metabolites analyzed, 137 metabolites were released from the brain in normothermia, and the release of 132 of these 137 metabolites was decreased in hypothermia. Two metabolites (dopamine and hexose) showed constant release from the brain in hypothermia, and 3 metabolites (2 glycophospholipids and 1 sphingomyelin) showed conversion from release to uptake in hypothermia. Glutamic acid demonstrated a distinct brain metabolism in that it was taken up by the brain in normothermia, and the uptake was increased in hypothermia. CONCLUSION: Targeted metabolomics demonstrated various degrees of changes in the release of metabolites by the hypothermic brain. The release of most metabolites was decreased in hypothermia, whereas glutamic acid showed a distinct brain metabolism.

Immediate versus staged complete revascularization in patients with ST-segment elevation myocardial infarction and multivessel coronary artery disease: results from a prematurely discontinued randomized multicenter trial.

BACKGROUND: We aimed to compare clinical outcomes between immediate and staged complete revascularization in primary percutaneous coronary intervention (PCI) for treating ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD). METHODS: A total of 248 patients were enrolled in a prospective, randomized, and multicenter registry. Immediate revascularization was defined as one-time PCI of culprit and non-culprit lesions at the initial procedure. Staged revascularization was defined as PCI of non-culprit lesions at a later date (mean, 4.4 days; interquartile range, 1-11.4), following initial culprit revascularization. The end points were major adverse cardiovascular events (MACE; composite of total death, recurrent myocardial infarction, and revascularization), any individual components of MACE, cardiac death, stent thrombosis, and stroke at 12 months. RESULTS: During a follow-up of 1 year, MACE occurred in 12 patients (11.6%) in the immediate revascularization group and in 8 patients (7.5%) in staged revascularization group (hazard ratio [HR] 1.60, 95% confidence interval [CI] 0.65-3.91). The incidence of total death was numerically higher in the immediate group than in the staged group (9.7% vs 2.8%, HR 3.53, 95% CI 0.97-12.84); There were no significant differences between the 2 groups in risks of any individual component of MACE, cardiac death, stroke, and in-hospital complications, such as need for transfusion, bleeding, acute renal failure, and acute heart failure. This study was prematurely terminated due to halt of production of everolimus-eluting stents (manufactured as PROMUS Element by Boston Scientific, Natick, Massachusetts). CONCLUSIONS: Due to its limited power, no definite conclusion can be drawn regarding complete revascularization strategy from the present study. Further large randomized clinical trials would be warranted to confirm optimal timing of complete revascularization for patients with STEMI and MVD.

Rapid combinatorial rewiring of metabolic networks for enhanced poly(3-hydroxybutyrate) production in Corynebacterium glutamicum.

BACKGROUND: The disposal of plastic waste is a major environmental challenge. With recent advances in microbial genetic and metabolic engineering technologies, microbial polyhydroxyalkanoates (PHAs) are being used as next-generation biomaterials to replace petroleum-based synthetic plastics in a sustainable future. However, the relatively high production cost of bioprocesses hinders the production and application of microbial PHAs on an industrial scale. RESULTS: Here, we describe a rapid strategy to rewire metabolic networks in an industrial microorganism, Corynebacterium glutamicum, for the enhanced production of poly(3-hydroxybutyrate) (PHB). A three-gene PHB biosynthetic pathway in Rasltonia eutropha was refactored for high-level gene expression. A fluorescence-based quantification assay for cellular PHB content using BODIPY was devised for the rapid fluorescence-activated cell sorting (FACS)-based screening of a large combinatorial metabolic network library constructed in C. glutamicum. Rewiring metabolic networks across the central carbon metabolism enabled highly efficient production of PHB up to 29% of dry cell weight with the highest cellular PHB productivity ever reported in C. glutamicum using a sole carbon source. CONCLUSIONS: We successfully constructed a heterologous PHB biosynthetic pathway and rapidly optimized metabolic networks across central metabolism in C. glutamicum for enhanced production of PHB using glucose or fructose as a sole carbon source in minimal media. We expect that this FACS-based metabolic rewiring framework will accelerate strain engineering processes for the production of diverse biochemicals and biopolymers.

Rapid-Deployment Aortic Valve Replacement in a Real-World All-Comers Population.

BACKGROUND: This study was conducted to evaluate the mid-term outcomes of rapid-deployment aortic valve replacement (AVR) using Edwards Intuity. METHODS: A total of 215 patients underwent rapid-deployment AVR using Edwards Intuity at our institution. The median follow-up duration was 22 months (interquartile range, 8-36). Primary outcomes were overall survival, cumulative incidence of cardiac death, and major adverse cardiac events. Secondary outcomes were early and 1-year hemodynamic performances of the bioprosthetic valve. RESULTS: The mean age was 68.6 ± 10.5 years, and EuroSCORE II was 3.09 ± 4.5. The study population included 113 patients (52.6%) with bicuspid valves (24 patients with type 0 bicuspid valves), 20 patients (9.3%) with pure aortic regurgitation, and 3 patients (1.4%) with infective endocarditis. Isolated AVR was performed in 70 patients (32.4%) and concomitant procedures were performed in 146 patients (67.6%), including aorta surgery (42.3%) and mitral valve procedure (22.3%). Operative mortality was 2.8%. Complete atrioventricular block occurred in 12 patients, but most of them were transient and only 3 patients received permanent pacemaker implantation before discharge. Overall survival at 3 years was 92.3%. Early hemodynamic data showed mean pressure gradients of 15.5 ± 5.0 and 12.7 ± 4.2 mm Hg in the 19 and 21 mm valve, respectively. One-year hemodynamics were also excellent with mean pressure gradients of 14.7 ± 5.3 and 10.7 ± 3.6 mm Hg in the 19 and 21 mm valve, respectively. CONCLUSION: Based on a real-world all-comers population, rapid-deployment AVR using Edwards Intuity could be performed for various indications, including bicuspid valve, pure aortic regurgitation, and infective endocarditis, and the clinical and hemodynamic outcomes were excellent.

Preliminary Report from a Randomized Controlled Trial Comparing Two Bovine Pericardial Valves.

BACKGROUND: A randomized controlled trial was designed to compare 1-year hemodynamic profiles and clinical outcomes after bioprosthetic aortic valve replacement (AVR) using a recently introduced (study group) and world-widely used (control group) bovine pericardial bioprostheses. This study evaluated early postoperative outcomes as a preliminary analysis. METHODS: The primary end point of the trial was the mean pressure gradient across the aortic valve (AVMPG) at 1 year after surgery. Patients were screened to enroll 70 patients in each group based on a noninferiority design. Early postoperative hemodynamic and clinical outcomes were compared between the two groups. RESULTS: There were no differences in baseline characteristics, including sex and body surface area (1.64 ± 0.18 vs. 1.65 ± 0.15 m2) between the two groups. The AVMPG on early postoperative echocardiography was 15.2 ± 4.6 mm Hg and 16.5 ± 6.2 mm Hg in the study and control groups, respectively (p = 0.177). Although AVMPG of the 19 mm prostheses was lower in the study group than in the control group (17.0 ± 6.3 mm Hg vs. 22.8 ± 6.6 mm Hg, p = 0.039), there were no significant differences in the effective orifice area in all patients (1.57 ± 0.41 cm2 vs. 1.53 ± 0.34 cm2, p = 0.568), and each valve size. The effective orifice area index was also similar between the two groups in overall (p = 0.352), and in each valve size. There were no significant differences in clinical outcomes including operative mortality and postoperative complications between the two groups. CONCLUSION: Early postoperative hemodynamic and clinical results after AVR using a recently introduced bovine pericardial valve were comparable with those using the control valve (NCT03796442).

Results after Tricuspid Valve Surgery for Preserved and Dysfunctional Right Ventricle.

BACKGROUND: This study aimed to compare long-term outcomes after tricuspid valve (TV) repair (TVr) with those after TV replacement (TVR) by adjusting the right ventricular (RV) volume and function. METHODS: We enrolled 147 patients who underwent TVr (n = 78) and TVR (n = 69) for grade 3 or 4 tricuspid regurgitation and had preoperative cardiac magnetic resonance data. Long-term clinical outcomes were compared between the two groups using inverse probability treatment weighting (IPTW) to adjust for differences in preoperative characteristics between the two groups. Subgroup analyses were performed in patients with preserved and dysfunctional RV (ejection fraction < 50%). RESULTS: There were no significant differences in operative mortality or postoperative complications between the two groups before and after the IPTW adjustment. Five- and 10-year overall survival rates were 84.2 and 67.1%, respectively. Five- and 10-year cumulative incidences of TV-related events (TVREs) were 33.1 and 55.6%, respectively. There were no significant differences in overall survival and cumulative incidence of TVREs after IPTW adjustment (p = 0.236 and p = 0.989, respectively). The risk-adjusted overall survival was marginally higher in the TVr group of patients with preserved RV function (p = 0.054), while no such significant difference was found between the two groups of patients with dysfunctional RV (p = 0.513). CONCLUSION: Adjusted long-term clinical outcomes after TVr and TVR were comparable. TVr might be beneficial for patients with preserved RV function in terms of long-term survival; however, this benefit might disappear in patients with RV dysfunction.

A Controlled Trial Comparing One-Year Hemodynamics of Two Bovine Pericardial Valves.

BACKGROUND: This randomized controlled trial was designed to compare 1-year hemodynamic performances and clinical outcomes after aortic valve replacement (AVR) using a recently introduced (the AVALUS group) and worldwide used (the CEPME group) bovine pericardial bioprostheses. METHODS: Patients were screened to enroll 70 patients in each group based on a noninferiority design. The primary endpoint of the trial was the mean pressure gradient across the aortic valve (AVMPG) at 1 year after surgery. One-year echocardiographic data were obtained from 92.1% (129 of 140 patients) of the study patients. RESULTS: There were no differences in baseline characteristics, including sex and body surface area (1.64 ± 0.18 vs. 1.65 ± 0.15 m2) between the groups. The AVMPG on 1-year echocardiography was 14.0 ± 4.3 and 13.9 ± 5.1 mmHg in the AVALUS and CEPME groups, respectively (the p-value for noninferiority was 0.0004). In the subgroup analyses for the respective size of the prostheses, AVMPG of the 19-mm prostheses was significantly lower in the AVALUS group than in the CEPME group (14.0 ± 4.3 vs. 20.0 ± 4.7 mmHg, p = 0.012), whereas those of the other sizes were not significantly different between the two groups. There were no significant differences in the effective orifice area (1.49 ± 0.40 vs. 1.53 ± 0.38 cm2, p = 0.500) or effective orifice area index (0.91 ± 0.22 vs 0.93 ± 0.23 cm2/m2, p = 0.570) in all the patients, or in the subgroup analysis for the 19-mm prosthesis. There were no differences in the 1-year clinical outcomes between the two groups. CONCLUSION: The 1-year hemodynamic and clinical outcomes of the AVALUS group were noninferior to those of the CEPME group (NCT03796442).

Aortic Valve Replacement in the Era of Transcatheter Aortic Valve Implantation: Current Status in Korea.

BACKGROUND: In the era of transcatheter aortic valve implantation, this study was conducted to investigate the current trend of aortic valve procedures in Korea and to evaluate the early and mid-term outcomes of isolated surgical aortic valve replacement (SAVR) using bioprosthetic valves in contemporary Korea. METHODS: Contemporary outcomes of isolated bioprosthetic SAVR in Korea were analyzed using the datasets on a multicenter basis. Patients who underwent isolated SAVR using bioprostheses from June 2015 to May 2019 were included, and those with concomitant cardiac procedures, SAVR with mechanical valve, or SAVR for infective endocarditis were excluded. A total of 456 patients from 4 large-volume centers were enrolled in this study. Median follow-up duration was 43.4 months. Early postoperative outcomes, mid-term clinical outcomes, and echocardiographic outcomes were evaluated. RESULTS: Mean age of the patients was 73.1 ± 7.3 years, and EuroSCORE II was 2.23 ± 2.09. The cardiopulmonary bypass time and aortic cross-clamp times were median 106 and 76 minutes, respectively. SAVR was performed with full median sternotomy (81.8%), right thoracotomy (14.7%), or partial sternotomy (3.5%). Operative mortality was 1.8%. The incidences of stroke and permanent pacemaker implantation were 1.1% and 1.1%, respectively. Paravalvular regurgitation ≥ mild was detected in 2.6% of the patients. Cumulative incidence of all-cause mortality at 5 years was 13.0%. Cumulative incidences of cardiovascular mortality and bioprosthetic valve dysfunction at 5 years were 7.6% and 6.8%, respectively. CONCLUSION: The most recent data for isolated SAVR using bioprostheses in Korea resulted in excellent early and mid-term outcomes in a multicenter study.

Incidence and Risk Factors of Pannus after Mechanical Aortic Valve Replacement.

BACKGROUND: This study was conducted to evaluate the occurrence rate and risk factors of subaortic pannus (SAP) after bileaflet mechanical aortic valve (AV) replacement. METHODS: Between 1990 and 2014, 862 patients underwent primary AV replacement with bileaflet mechanical prosthesis. SAP was defined as (1) gradual increase in mean pressure gradient through mechanical AV without any evidence of motion limitation of the leaflets on echocardiography and (2) AV mean pressure gradient >40 mm Hg or AV peak velocity >4 m/s on echocardiography, and (3) any visible subaortic tissue ingrowth beneath the mechanical AV on echocardiography or computed tomography. Clinical and echocardiographic follow-up durations were 13.8 ± 8.0 and 10.7 ± 7.9 years, respectively. RESULTS: Mean age was 51.1 ± 12.1 years and concomitant surgeries were performed in 503 patients (58.4%). Overall survival at 10 and 20 years was 84.2 and 67.1%, respectively. SAP occurred in 33 patients, and in only 2 patients during the first 10 years after surgery. The cumulative incidence of SAP formation at 10, 20, and 25 years were 0.3, 5.0, and 9.9%, respectively. The Fine and Gray model demonstrated that small prosthetic valve size (hazard ratio [HR] [95% confidence interval, CI] = 0.738 [0.575-0.946]), young age (HR [95% CI] = 0.944 [0.909-0.981]), and concomitant mitral valve replacement (MVR) (HR [95% CI] = 3.863 [1.358-10.988]) were significant risk factors for the SAP formation. CONCLUSIONS: SAP occurred gradually over time with 10- and 20-year cumulative incidence of 0.3 and 5.0%, respectively. Young age, small prosthetic valve size, and concomitant MVR were risk factors for SAP formation. Therefore, we recommend efforts to select large prostheses for young patients requiring concomitant MVR.

Real-World Three-Year Clinical Outcomes of Biolimus-Eluting Stents versus Other Contemporary Drug-Eluting Stents in Patients with Acute Myocardial Infarction Patients: Data from the Korea Acute Myocardial Infarction Registry (KAMIR).

INTRODUCTION: Biolimus-eluting stents (BES) are known to be superior to bare-metal stents. This study aims to evaluate the safety and efficacy of BES compared to other drug-eluting stents (DES) based on big data from the Korea Acute Myocardial Infarction Registry (KAMIR). METHODS: The study analyzed a total of 9,759 acute myocardial infarction (AMI) patients who underwent percutaneous coronary intervention (PCI) with DES. Total death, cardiac death, recurrent MI, revascularization, stent thrombosis, target lesion failure (TLF, composite of cardiac death, recurrent myocardial infarction (MI), and target lesion revascularization), and major adverse cardiac events (MACE, composite of total death, recurrent MI, and revascularization) were analyzed in patients with AMI up to three years. Study populations were divided into BES (n = 2,020), everolimus-eluting stents (EES, n = 5,293), and zotarolimus-eluting stents (ZES, n = 2,446) groups. RESULTS: To adjust baseline potential confounders, an inverse probability weighting (IPTW) analysis was performed. After IPTW, at three years, total death (7.2%, 8.6%, and 9.5%, P < 0.001), cardiac death (4.1%, 5.3%, and 6.6%, P < 0.001), recurrent MI (1.6%, 2.6%, and 3.2%, P < 0.001), TLF (6.5%, 8.1%, and 9.1%, P < 0.001), and MACE (15.8%, 17.5%, and 18.2%, P < 0.001) were lowest in the BES group compared with the other DES groups in AMI patients. During the 3-year clinical follow-up, the BES group showed better outcomes of MACE (hazard ratio (HR), 0.773; 95% confidence interval (CI), 0.676-0.884; P < 0.001), TLF (HR, 0.659; 95% CI, 0.538-0.808; P < 0.001), total death (HR, 0.687; 95% CI, 0.566-0.835; P < 0.001), and cardiac death (HR,0.593; 95% CI, 0.462-0.541; P < 0.001) than the EES groups. CONCLUSIONS: In this study, BES was superior to EES or ZES in reducing total death, cardiac death, TLF, and MACE in AMI patients.

Long-Term Clinical Outcomes of the On-X Mechanical Prosthetic Valve in the Aortic or Mitral Position　- A Single-Center Experience of up to 20 Years' Follow up.

BACKGROUND: This study evaluated the long-term outcomes for up to 20 years after On-X mechanical valve implantation in the left side of the heart.Methods and Results:Between 1999 and 2015, 861 patients (mean age=51.6±10.9 years) who underwent prosthetic valve replacement using the On-X valve in the aortic or mitral position were enrolled (aortic=344, mitral=325, double=192). The mean clinical follow-up duration was 10.5±5.3 (median 10.9) years. Operative mortality occurred in 26 patients (3.0%), and linearized late cardiac mortality was 0.9%/patient-year without an intergroup difference. Linearized thromboembolism, bleeding, prosthetic valve endocarditis, non-structural valve deterioration (NSVD), and reoperation rates were 0.8%/patient-year, 0.6%/patient-year, 0.2%/patient-year, 0.5%/patient-year, and 0.5%/patient-year, respectively. Prosthetic valve endocarditis was more frequent after double valve replacement than after aortic or mitral valve replacement (P=0.008 and 0.005, respectively). NSVD and reoperation rates were significantly lower aortic valve replacement than after mitral or double valve replacement (P=0.001 and 0.002, P=0.001 and <0.001, respectively). Valve replacement in the mitral position was the only risk factor for NSVD (hazard ratio [95% confidence interval]=5.247 [1.608-17.116], P=0.006). CONCLUSIONS: On-X valve implantation in the left side heart had favorable clinical outcomes with acceptable early and late mortality and a low incidence of prosthetic valve-related complications. Particularly in the aortic position, the On-X valve had better long-term non-structural durability.

Comparative analysis of structural valve deterioration after bioprosthetic tricuspid valve replacement: Bovine pericardial versus porcine valves.

This study was conducted to compare the occurrence and the risk factors of structural valve deterioration (SVD) after bioprosthetic tricuspid valve replacement (TVR) between bovine pericardial valves and porcine valves. One-hundred and thirty-four TVR patients were enrolled; 108 patients underwent TVR with bovine pericardial bioprostheses (BTVR group) and 26 underwent TVR with porcine bioprostheses (PTVR group). The early results and long-term clinical outcomes were compared. The median follow-up duration was 90 (interquartile range: 33-135) months. Propensity score (PS) adjusted Cox regression and competing risk analyses were performed. The mean ages of the BTVR and PTVR groups were 62.2 ± 10.7 and 57.3 ± 13.9 years, respectively. The overall survival and cumulative incidence of cardiac death in the BTVR group were similar to those in the PTVR group (hazard ratio [95% confidence interval] = 1.399 [0.500-3.922] and 0.742 [0.249-2.212], respectively). SVD was significantly more frequent in the BTVR group (17.544 [1.070-243.902], P = .045). The tricuspid valve reoperation rate was significantly higher in the BTVR group (38.462 [2.591-476.190], P = .008). The cumulative incidence of SVD after bioprosthetic TVR was higher when using bovine pericardial valves than when using porcine valves.

The Performance of the Current Risk Prediction Scoring Systems in Patients Undergoing Anaortic Off-pump Coronary Artery Bypass Grafting.

BACKGROUND: This study aimed to evaluate the performance of the Society of Thoracic Surgeons (STS) risk model and European System for Cardiac Operative Risk Evaluation (EuroSCORE) II for patients undergoing anaortic off-pump coronary artery bypass grafting (OPCAB). METHODS: From January 2010 to June 2017, 1,048 patients (isolated anaortic OPCAB: 1,043, on-pump conversion:5) undergoing isolated anaortic OPCAB were enrolled. The STS risk score and EuroSCORE II were calculated with dedicated online software. Calibration of the models were performed by the risk-adjusted event ratio that was defined as observed events divided by expected events (O/E ratio) and Hosmer-Lemeshow test. The discrimination powers were evaluated by the area under the receiver operating characteristic curve (AUC). RESULTS: Operative mortality occurred in 10 patients (0.95%). The predicted mortality rates by the EuroSCORE II and STS risk model were 2.58 ± 4.15% and 1.72 ± 2.92%, respectively. The O/E ratio of the EuroSCORE II was 0.370 with significant overprediction of operative mortality (confidence interval [CI], 0.157-0.652; P = 0.003). The STS score also overpredicted the operative mortality (O/E ratio, 0.556) with marginal significance (CI, 0.266-1.023; P = 0.052). Permanent stroke occurred in 6 patients (0.53%). The predicted permanent stroke occurrence rate was 1.73 ± 1.48%. The O/E ratio was 0.332 with significant overprediction of permanent stroke (CI, 0.121-0.722; P = 0.011). Regarding discrimination power for the STS risk model, the operative mortality was excellent (AUC, 0.876) and permanent stroke was acceptable (AUC, 0.740). The EuroSCORE II showed good discrimination power (AUC, 0.784). There was a significant difference in discrimination power for mortality between STS and EuroSCORE II risk models (P = 0.007). CONCLUSION: Preexisting risk predicting scoring systems, STS risk model and EuroSCORE II, overpredict the risk of mortality and stroke rate for anaortic OPCAB. These findings suggest the possibility that anaortic OPCAB can lower the operative mortality and occurrence of postoperative stroke than conventional coronary artery bypass grafting.

Early and Two-year Outcomes after Sutureless and Conventional Aortic Valve Replacement: a Nationwide Population-based Study.

BACKGROUND: We compared early and 2-year clinical outcomes of sutureless aortic valve replacement (SAVR) with conventional aortic valve replacement (CAVR) in a nationwide study based on claims data. METHODS: From December 2016 to November 2018, 3,173 patients underwent bioprosthetic aortic valve replacements. SAVR and CAVR were performed in 641 and 2,532 patients, respectively. Propensity score-matched analysis was performed in 640 patient pairs. RESULTS: Operative mortality rate was 2.8% without significant differences between the SAVR (3.4%) and CAVR (2.3%) groups (P = 0.324). There were no significant differences in postoperative morbidities between the groups except for permanent pacemaker (PPM) implantation. PPM implantation rate was significantly higher in the SAVR (3.8%) than in the CAVR group (0.9%) (P < 0.001). One- and two-year overall survival was 89.1% and 87.5%, respectively, without significant differences between the groups (SAVR group vs. CAVR grouP = 89.9% and 90.5% vs. 87.2% and 88.7%, respectively; P = 0.475). There were no significant differences in the cumulative incidence of cardiac death, stroke, aortic valve reoperation and infective endocarditis between the groups. Cumulative PPM implantation incidence at 6 months in the CAVR was 1.1%, and no patient required PPM implantation after 6 months. In the SAVR, the cumulative PPM implantation incidence at 0.5, one, and two years was 3.9%, 5.0% and 5.6%, respectively. The cumulative PPM implantation rate was higher in the SAVR group than in the CAVR group (P < 0.001). CONCLUSION: Early and 2-year clinical outcomes between SAVR and CAVR were not different except for a high rate of permanent pacemaker implantation in the SAVR group.

Pragmatic trial comparing routine versus no routine functional testing in high-risk patients who underwent percutaneous coronary intervention: Rationale and design of POST-PCI trial.

BACKGROUND: Although the need to detect restenosis has diminished in the contemporary practice of percutaneous coronary intervention (PCI) with drug-eluting stents (DES), the surveillance of ischemia owing to restenosis or disease progression deserves attention in high-risk PCI settings. It is unknown whether follow-up strategy of routine noninvasive functional testing potentially reduces the risk of major cardiovascular events in high-risk PCI patients. METHODS: The POST-PCI study is an investigator-initiated, multicenter, prospective randomized trial comparing the effectiveness of two follow-up strategies in patients with high-risk anatomic or clinical characteristics who underwent PCI. Study participants were randomly assigned to either (1) the routine noninvasive stress testing (exercise electrocardiography, nuclear stress imaging, or stress echocardiography) at 12 months post-PCI or (2) the standard-care without routine testing. In the routine stress testing group, depending on the testing results, all clinical decisions regarding subsequent diagnostic or therapeutic procedures were at the treating physician's discretion. The primary endpoint was a composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI. RESULTS: More than 1700 high-risk PCI patients have been randomized over 2.0 years at 11 major cardiac centers in Korea. CONCLUSION: This pragmatic POST-PCI trial will provide valuable clinical evidence on the effectiveness of follow-up strategy of routine noninvasive stress testing in high-risk PCI patients.

Impact of Mitral Valve Repair Case Volume on Postoperative Mortality　- A Nationwide Korean Cohort Study.

BACKGROUND: Although mitral valve repair is recommended over replacement due to better outcomes, repair rates vary significantly among centers. This study examined the effect of institutional mitral valve repair volume on postoperative mortality.Methods and Results:All cases of adult mitral valve repair performed in Korea between 2009 and 2016 were analyzed. The association between case volume and 1-year mortality was analyzed after categorizing centers according to the number of mitral valve repairs performed as low-, medium-, or high-volume centers (<20, 20-40, and >40 cases/year, respectively). The effect of case volume on cumulative all-cause mortality was also assessed. In all, 6,041 mitral valve repairs were performed in 86 centers. The 1-year mortality in low-, medium-, and high-volume centers was 10.1%, 8.7%, and 4.7%, respectively. Low- and medium-volume centers had increased risk of 1-year mortality compared with high-volume centers, with odds ratios of 2.80 (95% confidence interval [CI] 2.15-3.64; P<0.001) and 2.66 (95% CI 1.94-3.64; P<0.001), respectively. The risk of cumulative all-cause mortality was also worse in low- and medium-volume centers, with hazard ratios of 1.96 (95% CI 1.68-2.29; P<0.001) and 1.77 (95% CI 1.47-2.12; P<0.001), respectively. CONCLUSIONS: Lower institutional case volume was associated with higher mortality after mitral valve repair. A minimum volume standard may be required for hospitals performing mitral valve repair to guarantee adequate outcome.

Prospective partially randomized comparison of clopidogrel loading versus maintenance dosing to prevent periprocedural myocardial infarction after stenting for stable angina pectoris: Results from the "Method of Clopidogrel Pre-treatment Undergoing Conventional Coronary Angiogram in Angina Patients (MECCA)" study.

WHAT IS KNOWN AND OBJECTIVE: Pre-treatment of clopidogrel 600 mg is better than 300 mg loading for reducing periprocedural myocardial infarction (PMI). We aimed to evaluate pre-treatment methods for preventing PMI among patients undergoing conventional coronary angiography (CAG) for stable angina pectoris. MATERIALS AND METHODS: The study analyzed 402 patients who underwent percutaneous coronary intervention (PCI) during 2010 - 2011 at three Korean hospitals. Clopidogrel-naïve patients received routine maintenance therapy (75 mg/day for ≥ 5 days) and were randomly assigned to a 300-mg reload (RL) or only the maintenance dose (MD). Patients who received a loading dose (LD; 600 mg at 2 - 24 hours before the procedure) were entered into a non-randomized group. RESULTS: After excluding patients who showed an abnormal creatinine kinase myocardial band (CK-MB) level, the study included 233 patients in the LD group, 85 patients in the RL group and 84 patients in the MD group. The LD group had a significantly higher rate of PMI (LD: 21, RL: 3, MD: 0 cases; p = 0.007) and a significant increase in the mean CK-MB levels after 8 hours (p = 0.016) and 24 h (p = 0.01). However, there was no difference in PMI between the RL and MD groups. Furthermore, no significant differences between the three groups were observed in the P2Y12 reaction unit (PRU) values (p = 0.57). Albeit not significantly, the LD group had a higher rate of moderate-to-severe GUSTO bleeding within 7 days. WHAT IS NEW AND CONCLUSION: Clopidogrel maintenance is better than 600-mg loading for preventing PMI, and the RL protocol did not further prevent PMI.