Impact of sex on Transcatheter aortic valve replacement outcomes: Results of a single-center study.

BACKGROUND: Early studies on transcatheter aortic valve replacement (TAVR) outcomes showed that female sex was associated with better survival. With increased use of new-generation valves, the impact of sex on contemporary TAVR outcomes is less well known. METHODS: Retrospective analysis using institutional National Cardiovascular Data Registry STS/ACC TVT data was performed on all patients undergoing TAVR at Yale New Haven Hospital from July 2012 to August 2019. New-generation valves were Evolut PRO, Evolut R, and SAPIEN 3. Old-generation valves were CoreValve, SAPIEN, and SAPIEN XT. Log-rank test and Kaplan-Meier curves were used to compare sex differences in survival up to 1 year after TAVR. Cox modeling was used to adjust for baseline and procedural characteristic differences. RESULTS: 927 consecutive patients (41.4% women) underwent TAVR. Women were older (82.8 vs 80.6 years old; p < 0.001) with higher STS mortality scores compared with men (7.6% vs 6.4%; p < 0.001) despite lower prevalence of cardiovascular comorbidities including coronary artery disease, peripheral artery disease, and smoking. Most cases used transfemoral access (90.5%) and new-generation devices (72.3%). Women received smaller valves compared with men (20-26 mm: 78.0% vs 32.9%; 29-34 mm: 22.1% vs 67.1%; overall p < 0.0001). There were no statistically significant differences between sexes in both unadjusted and adjusted 1-year mortality. CONCLUSION: Our data show no significant difference in 1-year survival between sexes using primarily new generation valves. Further studies should reassess the impact of sex on TAVR outcomes and whether newer technologies like new valve design and sizes, and CT imaging may have eliminated sex-based disparities.

Early outcomes following transatrial transcatheter mitral valve replacement in patients with severe mitral annular calcification.

OBJECTIVE: Implantation of a transcatheter valve-in-mitral annular calcification (ViMAC) has emerged as an alternative to traditional surgical mitral valve (MV) replacement. Previous studies evaluating ViMAC aggregated transseptal, transapical, and transatrial forms of the procedure, leaving uncertainty about each technique's advantages and disadvantages. Thus, we sought to evaluate clinical outcomes specifically for transatrial ViMAC from the largest multicenter registry to-date. METHODS: Patients with symptomatic MV dysfunction and severe MAC who underwent ViMAC were enrolled from 12 centers across the United States and Europe. Clinical characteristics, procedural details, and clinical outcomes were abstracted from the electronic record. The primary end point was all-cause mortality. RESULTS: We analyzed 126 patients who underwent ViMAC (median age 76 years [interquartile range {IQR}, 70-82 years], 28.6% female, median Society of Thoracic Surgeons score 6.8% [IQR, 4.0-11.4], and median follow-up 89 days [IQR, 16-383.5]). Sixty-one (48.4%) had isolated mitral stenosis, 25 (19.8%) had isolated mitral regurgitation (MR), and 40 (31.7%) had mixed MV disease. Technical success was achieved in 119 (94.4%) patients. Thirty (23.8%) patients underwent concurrent septal myectomy, and 8 (6.3%) patients experienced left ventricular outflow tract obstruction (7/8 did not undergo myectomy). Five (4.2%) patients of 118 with postprocedure echocardiograms had greater than mild paravalvular leak. Thirty-day and 1-year all-cause mortality occurred in 16 and 33 patients, respectively. In multivariable models, moderate or greater MR at baseline was associated with increased risk of 1-year mortality (hazard ratio, 2.31; 95% confidence interval, 1.07-4.99, P = .03). CONCLUSIONS: Transatrial ViMAC is safe and feasible in this selected, male-predominant cohort. Patients with significant MR may derive less benefit from ViMAC than patients with mitral stenosis only.

Current state of transcatheter mitral valve implantation in bioprosthetic mitral valve and in mitral ring as a treatment approach for failed mitral prosthesis.

With heightened awareness of mitral valve disease and improvement in surgical techniques, the use of mitral valve bioprostheses has increased. There is a large aging population with prior surgical valvular interventions. Limited durability of the prosthesis due to valvular degeneration over time may necessitate the need for repair or replacement of the prior prosthesis in the future. This usually entails another surgical intervention in this population with elevated risk for a reoperation. There is an ongoing clinical need for newer, less invasive options that are feasible and carry a lower complication rate. The advent of transcatheter heart valve (THV) therapies has opened up a wide range of therapeutic options for treatment of a failed bioprosthesis. Their safety and feasibility are now well established. This article serves as a review of the currently available THVs for implantation in the mitral position, the pre-procedural assessment, the challenges associated with implantation, as well as outcomes associated with a mitral valve-in-valve (VIV) and a mitral valve-in-ring (VIR) procedure.

The axial distribution of lesion-site atherosclerotic plaque components: an in vivo volumetric intravascular ultrasound radio-frequency analysis of lumen stenosis, necrotic core and vessel remodeling.

Radio-frequency intravascular ultrasound (IVUS) analysis characterizes atherosclerotic plaques into necrotic core (NC), dense calcium (DC), fibrofatty (FF) and fibrotic (FI) tissue. We studied axial plaque component distribution with respect to stenosis and remodeling. Preintervention virtual histology (VH) IVUS was performed in 81 pts (90 de novo lesions: 43 left anterior descending artery [LAD] and 47 right coronary artery [RCA]). VH-IVUS at the reference, minimum lumen area (MLA) and maximum NC (MaxNC) sites were analyzed. Pullback length of 31.1 +/- 12.0 mm spanned a lesion length of 13.8 +/- 9.5 mm. The MaxNC site was located at the MLA in 3.3% of lesions, proximal to the MLA in 61% of lesions (by 4.11 mm) and distal to the MLA in 35.6% of lesions (by 3.56 mm). The %DC was greater at the MaxNC and %FI and %FF plaque were less than at the MLA site. Lesion fiberoatheromas (FAs) were more often detected at the MaxNC than the MLA (96% versus 51%) and were more often classified as thin-caped or multilayered than the MLA sites. The remodeling index was larger at the MaxNC than MLA sites and correlated with the NC area both at the MLA (r(2) 0.068, p = 0.013) and at the MaxNC (r(2) 0.074, p = 0.009). In conclusion, grey-scale and VH-IVUS analysis showed that the MLA is rarely at the site of greatest instability (largest NC and remodeling) and necrotic core on VH is correlated with remodeling index. These in vivo findings are consistent with previously reported histopathologic data and have important implications for the detection and treatment of coronary artery disease.

Mitral valve abnormalities in hypertrophic cardiomyopathy: echocardiographic features and surgical outcomes.

BACKGROUND: Functional and intrinsic mitral valve (MV) abnormalities are common in hypertrophic cardiomyopathy (HCM); however, morphologic characteristics constituting indications for surgical intervention are incompletely defined. This study was conducted to define the echocardiographic features of MV pathology in patients with HCM and relate these to repairability of the MV, MV procedures performed, durability of repair, and survival. METHODS: From 1986 to 2003, 851 patients with HCM underwent operation, and 115 had a concomitant MV procedure. Detailed analysis of their 784 transthoracic and transesophageal echocardiograms, performed intraoperatively and postoperatively, was conducted. Outcomes were assessed by cross-sectional follow-up. RESULTS: Sixty-seven patients (58%) underwent MV repair, and 48 (42%) had MV replacement. The mean left ventricular outflow tract peak gradient was 70 +/- 50 mm Hg. Systolic anterior motion was present in 95%. Valve abnormalities were degenerative in 36 (31%), myxomatous in 23 (20%), papillary muscle in 23 (20%), restrictive chordal in 22 (19%), restrictive leaflet in 80 (70%), and long leaflet in 64 (56%). Patients undergoing MV repair had higher prevalence of long leaflets and degenerative MV pathology. The anterior mitral leaflet was 3.0 +/- 0.49 cm in the repair group vs 2.5 +/- 0.40 cm in the replacement group (p = 0.0001). MV replacement patients were older, more symptomatic, and had more renal dysfunction and lower hematocrits. By 3 years, 91% of patients with a repair were free of reoperation. CONCLUSIONS: Intrinsic MV pathology is frequently observed in HCM patients with symptomatic obstruction who undergo myectomy. Echocardiography can identify MV features predictive of successful valve repair. Repair, although durable, is feasible in only about half of patients.

Necrotic core and its ratio to dense calcium are predictors of high-risk non-ST-elevation acute coronary syndrome.

Increased creatine kinase-MB levels and ST-segment depression are well-known prognostic factors in the setting of non-ST-elevation acute coronary syndrome (ACS). We hypothesized a relationship between virtual histology intravascular ultrasound (VH-IVUS) findings and these prognostic factors. We performed "whole vessel" VH-IVUS analysis in culprit arteries of 225 patients with ACS and measured the 4 basic VH-IVUS coronary plaque components--fibrous, fibrofatty, dense calcium (DC), and necrotic core (NC)--and calculated a NC/DC ratio. Patients' age was 62 +/- 11 years; 72% were men and 23% had diabetes. Only the NC/DC ratio had a positive association with creatine kinase-MB levels (r = 0.21, p = 0.03), and it was significantly higher for patients with ST-depression compared with those with non-ST-depression ACS (1.97 +/- 1.46 vs 1.58 +/- 1.10, p = 0.02). Sensitivity and specificity curves determined that a NC/DC value > or =2 (odds ratio 3.8, p = 0.01) and percentage of NC > or =6 (odds ratio 3.1, p = 0.04) were thresholds that best separated patients with high-risk non-ST-elevation ACS from those without abnormal creatine kinase-MB or ST depression. Patients with both predictors had significantly higher total cholesterol (204.7 +/- 60.5 vs 173.6 +/- 44.3 mg/dl, p = 0.01), higher low-density liprotein cholesterol (132.5 +/- 49.8 vs 101.3 +/- 33.2 mg/dl, p = 0.02), and more myocardial injury (creatine kinase-MB value of 42 +/- 38 vs 12 +/- 21, p = 0.01) than patients with no predictors. In conclusion, VH-IVUS analysis showed that the percentage of NC and its ratio to DC in diseased coronary segments are positively associated with a high-risk ACS presentation.

Current effectiveness and risks of isolated septal myectomy for hypertrophic obstructive cardiomyopathy.

BACKGROUND: Septal myectomy is the gold-standard therapy for hypertrophic obstructive cardiomyopathy (HOCM). However, it is being challenged by a less-invasive alternative: alcohol septal ablation. This study examined the clinical effectiveness and risks of isolated septal myectomy for HOCM. METHODS: From January 1994 to January 2005, 323 patients underwent isolated septal myectomy (mean age 50 +/- 14 years, 53% male). Preoperative septal thickness was 2.3 +/- 0.46 cm and peak left ventricular outflow tract (LVOT) gradient 68 +/- 43 mm Hg. Effectiveness of myectomy was assessed by echocardiography, sudden death, and functional limitation, early risks by intraoperative and postoperative complications, and late risks by follow-up for HOMC-related reoperation, heart block, and all-cause mortality (mean 3.6 +/- 2.8 years, 1,152 patient-years, 10% followed > or = 8 years). RESULTS: Myectomy was effective, resulting in sustained decrease in septal thickness and LVOT gradient, absence of sudden death, and improved functional status. Early in-hospital morbidity was low, with no hospital deaths; two iatrogenic ventricular septal defects were repaired uneventfully, and 22 pacemakers were required for heart block. In the intermediate term, 10 patients required HOCM-related reoperations (4 redo myectomies, 6 mitral valve procedures), with 92% freedom from reoperation at eight years. Seventy-nine percent were free of pacemakers by 8 years, and survival was 90%, equivalent to that of the general population. CONCLUSIONS: Isolated septal myectomy is effective in eliminating LVOT obstruction and sudden death and in improving functional status, with low operative morbidity and mortality. Few reoperations are required late and outcomes are excellent. It should be considered the treatment of choice for HOCM.

Natural history of ascending aortic aneurysms in the setting of an unreplaced bicuspid aortic valve.

BACKGROUND: Patients with bicuspid aortic valve (BAV) are at risk for valvular disease and ascending aortic aneurysms and dissections. Although others have investigated the need for concomitant repair, the natural history of aortic disease has not been addressed. METHODS: A review of our institutional clinical database identified 514 patients (326 male, 188 female) with unrepaired ascending aortic aneurysms followed from 1985 to 2005. Seventy patients (13.4%) diagnosed with BAV form group A; the remaining 445 patients form group B. Growth rates and risk factors for complications were assessed. RESULTS: Patients in group A had a lower incidence of hypertension (p = 0.0185), carotid artery disease, and stroke (p = 0.0184), and presented at an earlier age (49.0 versus 64.2 years, p < 0.0001). Group A also had a higher rate of aortic growth (0.19 versus 0.13 cm/year, p = 0.0102). The incidence of rupture and dissection were similar. Overall survival was better among patients with BAV (p < 0.0001). Among patients with BAV, those with aortic stenosis had a higher risk of rupture, dissection, or death before operative repair than did those with normally functioning valves (odds ratio 10.475, 95% confidence interval: 1.153 to 95.155). CONCLUSIONS: Aortic stenosis presents a significant added risk for patients with aneurysmal disease in the face of BAV. Despite faster rates of growth, however, patients with BAV have similar rates of aortic rupture, dissection, and death and improved long-term survival. Contributing to this finding may be the lower incidence of comorbidities, the younger age at presentation, and the more attentive follow-up with earlier operative repair.