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.

Patterns of genetic mutations explored by systematic screening of patients with aortopathy and their family members.

Objective: Genetic aortopathy, if left untreated, leads to aortic catastrophe in most affected individuals. We sought to determine the genetic mutation patterns and detection rates in patients with aortopathy and their families with a systematic screening protocol. Methods: In 2016 to 2020, patients with aortic dissection or root aneurysm (Z score ≥2) and their first-degree relatives were enrolled in a prospective registry at a tertiary referral center. The individuals underwent systematic single- or multi-gene panel testing depending on clinical presentations. Results: Among 575 enrolled individuals (mean age, 46.6 ± 14.5 years; 203 women), 346 (60.2%) underwent genetic testing. Rates of relevant gene mutations identified were 39.4% (91/231), 27.1% (54/199) and 72.4% (n = 105) in aneurysm, dissection, and family screening groups, respectively (P < .001). Mutated genes frequently identified were FBN1 (n = 199; Marfan), TGFBR1/2 or SMAD3 (n = 14; Loeys-Dietz), COL3A1/COL5A2 (n = 15; Ehlers-Danlos), and ACTA2 (n = 10). After enrollment, 123 aortic surgeries were performed in 117 patients (20.3%) including 15 family members, with resultant operative mortality of 0.8% (n = 1). In logistic regression analysis, systemic score in Ghent nosology was the only significant factor associated with positive gene mutation (odds ratio, 14.81; 95% confidence interval, 6.87-31.96), and its 3.5 point cutoff showed the best predictive value with 78.2% sensitivity and 87.2% specificity. Conclusions: Genetic aortopathy was identified in a considerable proportion of patients with aortopathy and their family members by systematic genetic testing. This strategy is recommended for timely diagnosis and proactive management of genetic aortopathy.

Impact of Optimal Medical Therapy on Long-Term Outcomes After Myocardial Revascularization for Multivessel Coronary Disease.

Although optimal medical therapy (OMT) after coronary revascularization is advocated for intensive secondary prevention, its criteria and effect on long-term outcomes are uncertain. Using data from the ASAN-Multivessel (Asan Medical Center-Multivessel Revascularization) registry, we identified 8,311 patients who underwent coronary artery bypass grafting (CABG) (n = 3,115) or percutaneous coronary intervention (PCI) (n = 5,196). OMT was defined as the combination of minimum of 3 medications in 4 drug classes (antiplatelet drugs, statins, ß blockers, and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers). Two primary outcomes were all-cause mortality and serious composite outcome of death, spontaneous myocardial infarction, or stroke at 10 years. Of 8,311 patients, 4,321 (52.0%) followed OMT. In the 3,397 propensity-score-matched cohort, OMT status compared with non-OMT status was significantly associated with a lower risk of all-cause mortality (10.7% vs 18.7%; hazard ratio [HR] 0.55, 95% confidence interval [CI] 0.47 to 0.65) and serious composite outcome (14.5% vs 22.5%, HR 0.635, 95% CI 0.55 to 0.73) at 10 years. The association on 10-year mortality was more prominent in the PCI group (HR 0.45, 95% CI 0.36 to 0.56) than in the CABG group (HR 0.72, 95% CI 0.58 to 0.90) with a significant interaction (p = 0.001). Overall findings were consistent using different OMT criteria (all 4 types of medications). In conclusion, OMT significantly lowered the risks of mortality and major cardiovascular events at 10 years in patients with multivessel revascularization. The OMT impact on mortality was more remarkable in the PCI group than in the CABG group. This work was registered at http://ClinicalTrials.gov (Identifier: NCT02039752).

Clinical outcomes after aortic valve replacement with severe stenosis of trileaflet aortic valve and low valve calcium score.

BACKGROUND: Some patients have severe aortic valve stenosis (AS) despite a lower degree of aortic valve calcification (AVC). This study compared the clinical features and prognosis of patients undergoing aortic valve replacement (AVR) for severe AS with a low AVC score compared with those with higher AVC scores. METHODS: This study included 1002 Korean patients with symptomatic severe degenerative AS who underwent AVR. We measured AVC score before AVR and defined low AVC as AVC score of <2000 units for male patients and <1300 units for female patients. Patients with bicuspid or rheumatic aortic valve disease were excluded. RESULTS: The mean age was 75.6±7.9 years and 487 patients (48.6%) were female. Mean left ventricular ejection fraction was 59.4%±10.4%, and concomitant coronary revascularisation was performed in 96 patients (9.6%). The median aortic valve calcium score was 3122 units (IQR 2249-4289 units) among male patients and 1756 units (IQR 1192-2572) among female patients. A total of 242 patients (24.2%) had low AVC; they were significantly younger (73.5±8.7 years vs 76.3±7.5 years, p<0.001) and were more likely to be female (59.5% vs 45.1%, p<0.001) and on haemodialysis (5.4% vs 1.8%, p=0.006) than those with high AVC. During a follow-up (median: 3.8 years), the patients with low AVC had significantly higher risk of death from any cause (adjusted HR 1.60, 95% CI 1.02 to 2.52, p=0.04), mostly non-cardiac cause. CONCLUSIONS: Patients with low AVC exhibit distinct clinical characteristics and a higher risk of long-term mortality compared with those with high AVC.

Myocardial Scar and Revascularization on Mortality in Ischemic Cardiomyopathy (from the Late Gadolinium Enhancement Cardiac Magnetic Resonance Study).

Myocardial viability test to guide revascularization remains uncertain in patients with ischemic cardiomyopathy. We evaluated the different impacts of revascularization on cardiac mortality according to the extent of myocardial scar assessed by cardiac magnetic resonance (CMR) with late gadolinium enhancement (LGE) in patients with ischemic cardiomyopathy. A total of 404 consecutive patients with significant coronary artery disease and an ejection fraction ≤35% were assessed by LGE-CMR before revascularization. Of them, 306 patients underwent revascularization and 98 patients received medical treatment alone. The primary outcome was cardiac death. During a median follow-up of 6.3 years, cardiac death occurred in 158 patients (39.1%). Revascularization was associated with a significantly lower risk of cardiac death than medical treatment alone in the overall population (adjusted hazard ratio [aHR] 0.29, 95% confidence interval (CI) 0.19 to 0.45, p <0.001). There was a significant interaction between the number of segments with >75% transmural LGE and revascularization on the risk of cardiac death (p = 0.037 for interaction). In patients with limited myocardial scar (<6 segments with >75% transmural LGE, n = 354), revascularization had a significantly lower risk of cardiac death than medical treatment alone (aHR 0.24, 95% CI 0.15 to 0.37, p <0.001); in patients with extensive myocardial scar (≥6 segments with >75% transmural LGE, n = 50), there was no significant difference between revascularization and medical treatment alone regarding the risk of cardiac death (aHR 1.33, 95% CI 0.46 to 3.80, p = 0.60). In conclusion, the assessment of myocardial scar by LGE-CMR may be helpful in the decision-making process for revascularization in patients with ischemic cardiomyopathy.

Developing Hemodynamic Valve Deterioration and Mortality in Aortic Valve Replacement.

BACKGROUND: As life span increases, in patients having a bioprosthetic valve, the development of hemodynamic valve deterioration (HVD) is an important concern. We evaluated the association of developing HVD to survival in patients undergoing surgical aortic valve replacement (SAVR). METHODS: The individuals undergoing isolated SAVR and serial echocardiography exams (interval >30 d) were included in this study. HVD was defined as mean pressure gradient ≥ 20 mmHg, mean pressure gradient ≥10 mmHg higher than in the baseline exam, or more than moderate regurgitation on Doppler echocardiography (moderate and severe grade). A time-dependent Cox proportional hazard model was used for this study. RESULTS: A total of 631 patients were included. The mean age was 71.8 ± 6.1 y old (female: 53.6%). HVD was found in 259 patients (41%) during echocardiographic follow-up (mean 3.3 ± 3.0 y). Patient-prosthetic mismatch was found in 174 patients. One hundred and twenty-six patients died during follow-up (median 62.1 mo, interquartile range 31.1-96.8). The development of HVD was an independent risk factor for death during follow-up (P = 0.038, hazard ratio 1.46, 95% confidential interval: 1.02-2.08). CONCLUSIONS: HVD was common after bioprosthetic SAVR during mid-term follow-up. Developing HVD, including moderate and severe grades, was associated with a poor survival rate compared with patients without HVD.

The fate of aortic valve after rheumatic mitral valve surgery.

OBJECTIVE: Deterioration of the native aortic valve function by a late progression of rheumatic disease is not infrequent in patients who underwent rheumatic mitral valve surgery; however, this phenomenon has not been clearly quantified. METHODS: A total of 1155 consecutive patients (age 52.0 ± 12.9 years; 807 female) who underwent rheumatic mitral valve surgery without concomitant aortic valve surgery from 1997 to 2015 were enrolled. The primary end point was the composite of progression to severe aortic valve dysfunction or a requirement of subsequent aortic valve replacements during follow-up. To determine the risk factors of the primary outcome, we performed the generalized linear mixed model. RESULTS: The baseline severities of aortic valve were none to trivial in 880 patients (76.2%), mild in 256 patients (22.2%), and moderate in 19 patients (1.6%). The latest 1062 echocardiographic assessments (91.9%; median, 81.2 postoperative months; interquartile range, 37.3-132.1 months) demonstrated 26 cases (0.33%/patient-year) meeting the primary end point during follow-up. Cumulative incidence of the primary end point at 10 years was 0.4% ± 0.3% and 7.4% ± 2.5% depending on the presence of mild or greater aortic valve dysfunction at baseline (P < .01). In multivariable analyses, aortic valve peak pressure gradient (odds ratio, 1.14; 95% confidence interval, 1.10-1.20), aortic regurgitation degree (mild over none: odds ratio, 3.26; 95% confidence interval, 1.15-9.23), and time (odds ratio, 1.30; 95% confidence interval 1.19-1.41) were significantly associated with the occurrence of the primary end point. CONCLUSIONS: Progression of severe aortic valve dysfunction and the need for aortic valve replacement are uncommon in patients undergoing rheumatic mitral valve surgery. However, such events were relatively common among those with mild or greater aortic valve dysfunction at the time of mitral valve surgery.

Surgical ablation for atrial fibrillation during aortic and mitral valve surgery: A nationwide population-based cohort study.

OBJECTIVE: There is limited evidence on the effectiveness of surgical atrial fibrillation ablation in reducing mortality or thromboembolic events during aortic/mitral valve surgery. We evaluated the association of surgical ablation versus no ablation with risks of all-cause death and ischemic stroke or systemic embolization among patients with preoperative atrial fibrillation undergoing concomitant aortic valve or mitral valve surgery. METHODS: With the use of administrative healthcare datasets from the Korean National Health Insurance Service database between 2003 and 2018, adult patients with atrial fibrillation undergoing aortic/mitral valve replacement or mitral valve repair were enrolled, and their outcomes were compared according to the performance of concomitant surgical ablation. The primary end points were all-cause death and thromboembolic event of ischemic stroke or systemic embolization. RESULTS: Among 17,247 patients with atrial fibrillation undergoing aortic/mitral valve surgery, 8716 (50.5%) received surgical ablation, whereas 8531 (49.5%) did not. During a median follow-up of 6.7 years (124,842.2 patient-years), death was less in the ablation group than in the no-ablation group (2.7 vs 4.1 patient-years; P < .001). The incidence of ischemic stroke or systemic embolization was also lower in the ablation group (0.9 vs 1.3 patient-years; P < .001). After adjustment with inverse probability of treatment weighting, surgical ablation was associated with decreased risks of all-cause death (hazard ratio, 0.86; 95% confidence interval, 0.80-0.92), ischemic stroke or systemic embolization (hazard ratio, 0.62; 95% confidence interval, 0.55-0.71), and hospitalization from heart failure (hazard ratio, 0.87; 95% confidence interval, 0.79-0.96). CONCLUSIONS: In patients with atrial fibrillation undergoing aortic/mitral valve surgery, concomitant surgical ablation was significantly associated with lower risks of mortality and thromboembolic events.

Incremental Prognostic Value of Left Ventricular Global Longitudinal Strain in Patients with Preserved Ejection Fraction Undergoing Transcatheter Aortic Valve Implantation.

BACKGROUND: Evaluation of left ventricular global longitudinal strain (LVGLS) has allowed better characterization than left ventricular ejection fraction (LVEF) of subtle differences in left ventricular performance. The aim of this study was to determine whether LVGLS has prognostic value in patients with severe aortic stenosis and preserved LVEF undergoing transcatheter aortic valve implantation (TAVI). METHODS: Among 412 consecutive patients who underwent TAVI, 344 patients (mean age, 78.9 ± 5.0 years; 161 men) with preserved LVEF (≥50%) at baseline were analyzed. Patients with low LVEF (<50%) were used as a comparison group in the survival analysis. The primary and secondary end points were all-cause death and a composite of cardiovascular death and heart failure hospitalization, respectively. RESULTS: The mean LVGLS and LVEF were -17.1 ± 2.7% and 63 ± 5%, respectively. Impaired LVGLS was defined as >-16%, which was the first LVGLS quartile (cutoff value, -16%). The estimated actuarial 5-year survival rate was 81.7 ± 4.2% in the normal LVGLS group and 66.8 ± 7.5% in the impaired LVGLS group (P = .005). In the multivariable analysis, impaired LVGLS was an independent predictor of all-cause death (adjusted hazard ratio, 2.26; 95% CI, 1.11-4.60) and the composite outcome (adjusted hazard ratio, 3.03; 95% CI, 1.45-6.33). Moreover, the impaired LVGLS group had a poor prognosis, similar to the impaired LVEF group (<50%). The addition of the absolute value of LVGLS to the clinical parameters and LVEF led to significant improvement in the prediction of all-cause mortality. CONCLUSIONS: In patients with severe aortic stenosis and preserved LVEF undergoing TAVI, subclinical LV dysfunction defined by impaired LVGLS is independently associated with poor clinical outcomes. LVGLS measurement provides incremental prognostic value above the established clinical and echocardiographic parameters.

Spontaneous Resolution of Extensive Iatrogenic Type A Aortic Dissection After Transcatheter Aortic Valve Replacement.

The management of type A aortic dissection (TAAD) during transcatheter aortic valve replacement (TAVR) is challenging because TAVR is often performed in elderly patients with significant surgical risk. We present a case of extensive TAAD that developed during the TAVR procedure, which resolved spontaneously with medical treatment. (Level of Difficulty: Intermediate).

Aortic arch isolation to reduce cerebral embolic risk during replacement of the atherosclerotic aortic arch.

OBJECTIVE: To analyze the efficacy of isolating the upper body circulation from the lower body (isolation technique) in reducing the risk of embolic stroke during cardiopulmonary bypass in patients with severe atherosclerosis undergoing aortic arch surgery. METHODS: Between 2006 and 2019, 156 patients with severe atherosclerosis undergoing total arch replacement were enrolled. Since 2017, the right axillary or innominate artery and ascending aorta were both cannulated before cardiopulmonary bypass in the isolation group (n = 30). The left common carotid artery was clamped and inserted with a 13-Fr balloon perfusion catheter. The innominate artery was clamped in succession and cardiopulmonary bypass was instituted, establishing a parallel noncommunicating circulation for the upper and lower body. Patients without atherosclerosis that were not considered at high risk of embolic complications were excluded. The no-isolation group was drawn from historically matched control patients undergoing total arch replacement. RESULTS: The permanent stroke rate in the isolation and no-isolation groups were 3.3% (n = 1) and 15.9% (n = 15.9), respectively. After inverse-probability-of-treatment-weighting adjustment, the early mortality (P = .043), stroke (P = .044), and composite of early mortality or stroke (P = .005) rates were significantly lower in the isolation group. The logistic regression analysis after inverse-probability-of-treatment-weighting risk adjustment showed a significantly reduced composite risk of early death and stroke in the isolation group (odds ratio, 0.09; 95% confidence interval, 0.01-0.70; P = .023). CONCLUSIONS: The isolation technique was associated with a significant reduction in early postoperative embolic stroke and mortality risks in patients with severe aortic atherosclerosis undergoing total arch replacement.

Prognostic Impact of Mildly Impaired Renal Function in Patients Undergoing Multivessel Coronary Revascularization.

BACKGROUND: The long-term prognostic impact of mildly decreased renal function in patients undergoing coronary revascularization is still unknown. OBJECTIVES: The goal of this study was to investigate the long-term prognostic impact of mildly decreased renal function and comparative outcomes after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in such a risk group of patients. METHODS: From the Asan Medical Center-Multivessel Revascularization registry, 10,354 eligible patients who underwent coronary revascularization were classified into 3 groups (stage I [n = 3,735]: normal renal function; stage II [n = 5,122]: mild dysfunction; and stage III [n = 1,497]: moderate dysfunction) according to estimated glomerular filtration rate. The primary outcome was the composite of death, spontaneous myocardial infarction, or stroke. Propensity score matching was used to assemble a cohort of patients with similar baseline characteristics. RESULTS: After propensity matching, the risk for primary composite outcome was not different between the stage I and the stage II group (HR: 1.12; 95% CI: 0.97-1.30). However, the risk of the primary outcome was significantly higher in the stage III group than in the stage I group (HR: 1.50; 95% CI: 1.22-1.84). The relative effect of PCI vs CABG for the primary outcome was similar in the matched cohort of each renal function group of stages I, II, and III. CONCLUSIONS: In patients with multivessel disease after revascularization by PCI or CABG, the presence of mildly decreased renal function was not significantly associated with an increased risk of the primary composite outcome and mortality. Comparative outcomes after PCI and CABG were similar in the borderline-risk group. (Asan Medical Center-Multivessel Revascularization registry; NCT02039752).

Mini-thoracotomy and full-sternotomy approach for reoperative mitral valve surgery after a previous sternotomy.

OBJECTIVES: Right mini-thoracotomy approach may enhance the visualization of mitral valve (MV) visualization during redo MV surgery, thereby minimizing the risk of reoperative median sternotomy. We described the clinical outcomes of redo MV surgery by mini-thoracotomy and full-sternotomy approach. METHODS: Of 730 consecutive adult patients who underwent redo MV surgery between 2002 and 2018 at our institution, we identified 380 patients (age: 56.0 [14.8] years) after excluding those who underwent concomitant aortic valve or coronary artery surgeries. RESULTS: The clinical outcomes in patients who underwent mini-thoracotomy (MINI group; n = 168) and full-sternotomy (STERN group; n = 218) were described. The early and overall mortality in the MINI group was 4.3% (7/162) and 17.3% (28/162), with the rates of early major complications as follows: low cardiac output syndrome, 5.6% (9/162); early stroke, 6.8% (11/162); new-onset dialysis, 6.2% (10/162); prolonged ventilation, 15.4% (25/162); and postoperative bleeding requiring exploration, 7.4% (12/162). In the STERN group, the early mortality was 11.0% (24/218), whereas the risk of low cardiac output syndrome, early stroke, new-onset dialysis, prolonged ventilation, and postoperative bleeding was 12.4% (27/218), 14.2% (31/218), 17.0% (37/218), 33.0% (72/218), and 10.1% (22/218), respectively. The duration of intensive care unit and hospital stay was 2.0 [range 1.0, 3.0] and 8.0 [6.0, 13.0], respectively, in the MINI group and 3.0 [2.0, 7.0] and 14.0 [8.0, 29.0], respectively, in the STERN group. CONCLUSIONS: Mini-thoracotomy may be a viable alternative to conventional sternotomy for redo MV surgery.

Inter-racial differences in patients undergoing transcatheter aortic valve implantation.

OBJECTIVE: Little information exists about inter-racial differences in patients with aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI). We investigated whether differences in baseline characteristics between Asian and non-Asian population may contribute to disparities in clinical outcomes after TAVI. METHODS: We performed a registry-based, multinational cohort study of patients with severe AS who underwent TAVI at two centres in the USA and one centre in South Korea. The primary outcome was a composite of death, stroke or rehospitalisation at 1 year. RESULTS: Of 1412 patients, 581 patients were Asian and 831 were non-Asian (87.5% white, 1.7% black, 6.1% Hispanic or 4.7% others). There were substantial differences in baseline characteristics between two racial groups. The primary composite outcome was significantly lower in the Asian group than in the non-Asian group (26.0% vs 35.0%; HR 0.73; 95% CI 0.59 to 0.89; p=0.003). However, after adjustment of baseline covariates, the risk of primary composite outcome was not significantly different (HR 0.79; 95% CI 0.60 to 1.03; p=0.08). The all-cause mortality at 1 year was significantly lower in the Asian group than the non-Asian group (7.4% vs 12.5%; HR 0.60; 95% CI 0.41 to 0.88; p=0.009). After multivariable adjustment, the risk of all-cause mortality was also similar (HR 1.17; 95% CI 0.73 to 1.88; p=0.52). CONCLUSIONS: There were significant differences in baseline and procedural factors among Asian and non-Asian patients who underwent TAVI. Observed inter-racial differences in clinical outcomes were largely explained by baseline differences in clinical, anatomical and procedural factors. TRIAL REGISTRATION NUMBER: NCT03826264 (https://wwwclinicaltrialsgov).

Implication of Different ECG Left Ventricular Hypertrophy in Patients Undergoing Transcatheter Aortic Valve Replacement.

Background Various ECG criteria for left ventricular hypertrophy (LVH) have been proposed, but their association with clinical outcomes in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement is unknown. We investigated the prevalence of ECG LVH according to different criteria and its prognostic impact on clinical outcomes after transcatheter aortic valve replacement. Methods and Results In this prospective observational cohort, we evaluated 700 patients who underwent transcatheter aortic valve replacement between March 2010 and December 2019. Baseline preprocedural LVH was defined by 3 ECG criteria-Sokolow-Lyon, Romhilt-Estes, and Cornell voltage criteria. The primary outcome was major adverse cardiac or cerebrovascular event (MACCE; composite of death, myocardial infarction, stroke, or rehospitalization from cardiovascular cause); the key secondary outcome was all-cause and cardiovascular mortality. Among 596 eligible patients, the prevalence of LVH was determined as 56.3% by Sokolow-Lyon, 31.1% by Romhilt-Estes, and 48.1% by Cornell criteria. Regardless of the criteria, patients with ECG LVH had more severe aortic stenosis hemodynamics and higher left ventricular mass index. After multivariate adjustment, the presence of LVH by the Cornell criteria was significantly associated with lower risks of MACCE (adjusted hazard ratio [HR], 0.68; 95% CI, 0.51-0.91; P=0.009), all-cause mortality (adjusted HR, 0.55; 95% CI, 0.34-0.90 [P=0.017]), and cardiovascular mortality (adjusted HR, 0.40; 95% CI, 0.20-0.79 [P=0.008]). However, this association was absent with the Sokolow-Lyon and Romhilt-Estes criteria. Conclusions ECG LVH by Cornell criteria only was significantly associated with lower risks of MACCE and all-cause or cardiovascular mortality. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03298178.

Bioprosthesis in the Mitral Position: Bovine Pericardial versus Porcine Xenograft.

BACKGROUND: While the use of bioprosthetic valves for mitral valve replacement (MVR) is increasing, very few studies have compared bovine pericardial and porcine valves in the mitral position to help guide bioprosthetic selection. METHODS: In the present study, patients who underwent MVR using bovine pericardial valves were compared with those who underwent MVR with porcine bioprostheses between January 1996 and July 2018. Those with prior MVR, infective endocarditis, congenital mitral valve disease, or ischemic mitral regurgitation were excluded. The primary outcomes were structural valve deterioration (SVD) and mitral valve reoperation from any cause, and death was regarded as a competing risk. Competing risk analysis and propensity score-matching were used for comparisons. RESULTS: Among the 388 patients enrolled, pericardial and porcine bioprostheses were implanted in 217 (55.9%) and 171 (44.1%), respectively. Propensity score-matching yielded 122 pairs of patients that were well-balanced for all baseline covariates. No significant differences were observed between the groups in unadjusted (p=0.09) and adjusted overall survival (hazard ratio [HR], 1.13; 95% confidence interval [CI], 0.72-1.76; p=0.60). Competing risk analysis revealed no significant differences in the risks of mitral reoperation (HR, 1.07; 95% CI, 0.50-2.27; p=0.86) and development of SVD (HR, 1.57; 95% CI, 0.56-4.36; p=0.39) between the groups. Matched population analysis confirmed similar results regarding reoperation (HR, 0.99; 95% CI, 0.40-3.22; p=0.98) and SVD (HR, 1.39; 95% CI, 0.41- 4.73; p=0.60). CONCLUSION: No significant differences in survival or valve durability were observed between bovine pericardial and porcine bioprosthetic MVR. These findings require further validation through studies with larger sample sizes.

Pericardial Versus Porcine Valves for Surgical Aortic Valve Replacement.

BACKGROUND AND OBJECTIVES: There still are controversies on which type between bovine pericardial and porcine valves is superior in the setting of aortic valve replacement (AVR). This study aims to compare clinical outcomes of AVR using between pericardial or porcine valves. METHODS: The study involved consecutive 636 patients underwent isolated AVR using stented bioprosthetic valves between January 2000 and May 2016. Of these, pericardial and porcine valves were implanted in 410 (pericardial group) and 226 patients (porcine group), respectively. Clinical outcomes including survival, structural valve deterioration (SVD) and trans-valvular pressure gradient were compared between the groups. To adjust for potential selection bias, inverse probability treatment weighting (IPTW) was conducted. RESULTS: The mean follow-up duration was 60.1±50.2 months. There were no significant differences in the rates of early mortality (3.1% vs. 3.1%; p=0.81) and SVD (0.3%/patient-year [PY] vs. 0.5%/PY; p=0.33) between groups. After adjustment using IPTW, however, landmark mortality analyses showed a significantly lower late (>8 years) mortality risk in pericardial group over porcine group (hazard ratio [HR], 0.61; 95% confidence interval, [CI] 0.41-0.90; p=0.01) while the risks of SVD were not significantly difference between groups (HR, 0.45; 95% CI, 0.12-1.70; p=0.24). Mean pressure gradient across prosthetic AV was lower in the Pericardial group than the Porcine group at both immediate postoperative point and latest follow-up (p values <0.001). CONCLUSIONS: In patients undergoing bioprosthetic surgical AVR, bovine pericardial valves showed superior results in terms of postoperative hemodynamic profiles and late survival rates over porcine valves.

Association of aortic valvular complex calcification burden with procedural and long-term clinical outcomes after transcatheter aortic valve replacement.

AIMS: This study aimed to assess the impact of valvular/subvalvular calcium burden on procedural and long-term outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS). METHODS AND RESULTS: In this prospective observational cohort study, we included patients with AS undergoing TAVR between March 2010 and December 2019. Calcium burden at baseline was quantified using multidetector computed tomography and the patients were classified into tertile groups according to the amount of calcium. Procedural outcomes [paravalvular leakage (PVL) or permanent pacemaker insertion (PPI)] and 12-month clinical outcomes (composite of death, stroke, or rehospitalization, and all-cause mortality) were assessed. A total of 676 patients (age, 79.8 ± 5.4 years) were analysed. The 30-day rates of moderate or severe PVL (P-for-trend = 0.03) and PPI (P-for-trend = 0.002) proportionally increased with the tertile levels of calcium volume. The 12-month rate of primary composite outcomes was 34.2% in low-tertile, 23.9% in middle-tertile, and 25.8% in high-tertile groups (log-rank P = 0.02). After multivariable adjustment, the risk for primary composite outcomes at 12 months was not significantly different between the tertile groups of calcium volume [reference = low-tertile; middle-tertile, hazard ratio (HR) 0.81; 95% confidence interval (CI) 0.54-1.22; P = 0.31; high-tertile, HR 0.93; 95% CI 0.56-1.57; P = 0.80]. A similar pattern was observed for all-cause mortality. CONCLUSION: The rates of PVL and PPI proportionally increased according to the levels of valvular/subvalvular calcium volume, while the adjusted risks for composite outcomes and mortality at 12 months were not significantly different.