Goel, Kashish

BACKGROUND: The EARLY TAVR trial (Evaluation of TAVR Compared to Surveillance for Patients with Asymptomatic Severe Aortic Stenosis) demonstrated that early transcatheter aortic valve replacement (TAVR) was superior to clinical surveillance (CS) in asymptomatic severe aortic stenosis. The relative impact of early TAVR versus CS strategy by age is unknown. METHODS: The study population of the EARLY TAVR trial was stratified into 4 age groups: 65 to 69 years (n=141), 70 to 74 years (n=263), 75 to 79 years (n=250), and ≥80 years (n=247). Associations between age and the trial primary end point of death, stroke, or unplanned cardiovascular hospitalization; the composite end point of death, stroke, or heart failure hospitalization; and its individual components were examined. Interaction tests evaluated whether the treatment effect of early TAVR versus CS differed by age. RESULTS: No interaction was detected between age and the treatment effect of early TAVR versus CS for the composites or individual outcomes. We observed lower stroke rates with early TAVR compared with CS in the youngest (65–69 years, absolute risk reduction, 13%; P =0.008) and oldest (≥80 years; absolute risk reduction, 12.3%; P =0.029) age groups. The absolute difference in heart failure hospitalization rates between the early TAVR and CS arms at 2 years was greatest in the oldest patients (≥80 years, 9.1%; 75–79 years, 5.9%; 70–74 years, 5.1%; 65–69 years, 4.4%). In the CS group, time to conversion to AVR was similar across all age groups (median, 11 months; P =0.73). Approximately one-third of younger patients (65–69 years) in the CS arm presented with acute valve syndrome at the time of conversion, the frequency of which tended to increase with age ( P =0.06). CONCLUSIONS: In the EARLY TAVR trial, the relative benefit of early TAVR over CS was consistent among all age groups. The greatest absolute reduction in stroke rate with early TAVR compared with CS appeared in the youngest and oldest groups, whereas reduction in heart failure hospitalization was most pronounced in the oldest patients. These data suggest that early TAVR should be considered in all age groups above 65 years. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03042104.

BACKGROUND: Previous transcatheter valve therapy registry analyses of transcatheter mitral valve in valve (MViV) replacement of degenerated bioprosthesis reported early experience in the United States. Given recent increases in transseptal MViV volumes and introduction of the SAPIEN 3 Ultra valve, it is important to determine contemporary outcomes for patients undergoing transseptal SAPIEN 3/SAPIEN 3 Ultra MViV replacement. METHODS: The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy Registry was used to extract data for all patients undergoing transseptal SAPIEN 3/SAPIEN 3 Ultra MViV from 2015 to September 2022. Primary efficacy outcome was 1-year all-cause mortality. Secondary end points included 30-day mortality, functional class, quality of life, and mitral valve performance. Primary safety outcomes were device success and in-hospital complications. RESULTS: A total of 4243 patients with a mean±SD STS score of 9.2±7.7 underwent transseptal MViV at 455 sites. The rate of Mitral Valve Academic Research Consortium technical (96.6%) success was high, and procedural complications were low. All-cause in-hospital, 30-day, and 1-year mortality rates were 3.2%, 4.3%, and 13.4%, respectively. Significant improvements in New York Heart Association class (New York Heart Association I/II, 18% to 87%) and quality of life (Kansas City Cardiomyopathy Questionnaire score, 38 to 78) were noted at 1 year ( P <0.0001 for both) after MViV. Upon stratifying by STS scores, it was observed that the low-risk group (STS<4) had a significantly lower in-hospital mortality rate of 0.4%, whereas the intermediate-risk group (STS, 4–8) had an in-hospital mortality rate of 1.9%. From 2015 to 2022, the number of transseptal MViV cases/year increased significantly, whereas procedure times, length of stay, and intensive care unit hours shortened significantly. At the same time, there was a significant trend toward reduced in-hospital ( P =0.0005), 30-day ( P =0.004), and 1-year mortality rates ( P =0.01). CONCLUSIONS: This multicenter, prospective study reports excellent procedural outcomes, acceptable 1-year mortality rates, and a significant improvement in quality of life for patients undergoing transseptal MViV in the contemporary era. Patients in the low-risk and intermediate-risk STS score categories had significantly better outcomes compared with those in the high-risk category. MViV is a reasonable therapy for the majority of patients with degenerated bioprosthetic mitral valves, who are anatomical candidates.

Thais Coutinho, 2011 Finalist and Presenting Author

Importance In patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited. Objective To report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial. Design, Setting, and Participants SURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August and October 2021. Intervention Patients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis. Main Outcomes and Measures The prespecified secondary end points of death or disabling stroke and other adverse events and hemodynamic findings at 5 years. An independent clinical event committee adjudicated all serious adverse events and an independent echocardiographic core laboratory evaluated all echocardiograms at 5 years. Results A total of 1660 individuals underwent an attempted TAVR (n = 864) or surgical (n = 796) procedure. The mean (SD) age was 79.8 (6.2) years, 724 (43.6%) were female, and the mean (SD) Society of Thoracic Surgery Predicted Risk of Mortality score was 4.5% (1.6%). At 5 years, the rates of death or disabling stroke were similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI, 0.85-1.22]; P = .85). Transprosthetic gradients remained lower (mean [SD], 8.6 [5.5] mm Hg vs 11.2 [6.0] mm Hg; P &amp;lt; .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm 2 vs 1.8 [0.6] cm 2 ; P &amp;lt; .001) with TAVR vs surgery. More patients had moderate/severe paravalvular leak with TAVR than surgery (11 [3.0%] vs 2 [0.7%]; risk difference, 2.37% [95% CI, 0.17%- 4.85%]; P = .05). New pacemaker implantation rates were higher for TAVR than surgery at 5 years (289 [39.1%] vs 94 [15.1%]; hazard ratio, 3.30 [95% CI, 2.61-4.17]; log-rank P &amp;lt; .001), as were valve reintervention rates (27 [3.5%] vs 11 [1.9%]; hazard ratio, 2.21 [95% CI, 1.10-4.45]; log-rank P = .02), although between 2 and 5 years only 6 patients who underwent TAVR and 7 who underwent surgery required a reintervention. Conclusions and Relevance Among intermediate-risk patients with symptomatic severe aortic stenosis, major clinical outcomes at 5 years were similar for TAVR and surgery. TAVR was associated with superior hemodynamic valve performance but also with more paravalvular leak and valve reinterventions.

Introduction: The risk of stroke or transient ischemic attack (TIA) remains increased after transcatheter aortic valve replacement (TAVR), especially in the first 30 days. Limited data is available regarding the impact of procedural characteristics on risk of stroke/TIA. Hypothesis: Post deployment balloon dilatation (PD) and total number of balloon dilatations (pre, valve and post insertion) may be associated with increased risk of stroke/TIA in patients undergoing TAVR. Methods: We included consecutive patients who underwent balloon-expandable TAVR until June 2014 at Mayo Clinic, Rochester. Patients who died in the operating room, converted to open surgery, or had valve-in-valve, or underwent self-expanding TAVR were excluded. Primary end-point was stroke or TIA at 30 days. Results: Mean age was 80.9±8 y, mean STS score was 8.3±5 and 50% underwent transfemoral access. The overall incidence of PD was 14% (n=53). Total number of dilations ranged from 2-7, with 5% (n=19) getting ≥ 4 total dilatations. Out of the 370 patients, 13 patients (3.5%) suffered stroke/TIA (9.4% in PD group vs. 2.2% in non-PD group) in the first 30 days after TAVR. Cox-proportional hazards regression analysis indicated that PD during TAVR was associated with a significantly increased risk of 30-day stroke/TIA (HR, 3.8; 95% CI, 1.2-11.6; p=0.02). There was a trend towards increased stroke/TIA with total number of dilations (HR, 1.5; 95% CI, 0.87-2.6; p=0.14), longer procedural time (HR per 30 minutes, 1.3; 95% CI, 0.96-1.7; p=0.09) and severity of atherosclerosis (moderate-severe - HR, 1.9; 95% CI 0.95- 3.8; p=0.07). PD was not significantly associated with the risk of 30 day death (HR, 1.1; 95% CI, 0.24-4.85; p=0.93). Conclusions: In patients undergoing PD after balloon-expandable TAVR, 9.4% suffered a stroke or TIA in the first 30 days. PD was associated with a four-fold increase in 30 day risk of stroke or TIA.

Background: Cardiac rehabilitation (CR) improves functional capacity after heart valve surgery (HVS), but no survival benefit has yet been described. We hypothesized that attendance at CR after HVS would be associated with improved long-term survival. Methods: In 2013, we surveyed all patients (or a close family member if the patient was deceased) who had isolated HVS between 2006 through 2010 at the Mayo Clinic to assess if they attended CR after their HVS. We assessed survey reliability among local patients by comparing self-reported vs. medical-record verified CR attendance with the kappa statistic. We then performed a propensity-adjusted landmark mortality analysis through October 2014 for the association between CR attendance and long-term all-cause mortality conditional upon surviving the first year after HVS. Results: Survey response rate was 40% (573/1420), with responders more likely to be older, have longer hospitalizations, more aortic valve disease, but have better survival than non-responders. Among local patients, there was “substantial” agreement between reported attendance and medical-record verified CR attendance (agreement at 84%, kappa = 0.62.) A total of 547 patients (age 70 yrs., 62% male, 59% aortic valve surgery) with valid survey responses were included in the propensity analysis, of whom 296 (54.1%) attended CR. There were 100 deaths during a median follow-up of 5.4 years. For all patients, the propensity-adjusted model suggested no impact of CR on mortality (HR 1.03, 95% CI, 0.66 to 1.62). When stratified by procedure type, results suggested a potentially favorable, but non-significant, effect among patients with mitral valve surgery (HR 0.49, 95% CI 0.15 to 1.56), but not among patients with aortic valve surgery (HR 1.00, 95% CI 0.61 to 1.64.) Conclusions: Important improvements in functional capacity from CR have been previously reported after HVS, but, contrary to our hypothesis, we found that CR does not provide long-term survival benefits after HVS. These findings need additional confirmation to better clarify any mortality impact that may exist for CR following HVS, particularly among patients undergoing mitral valve surgery.

Background: Spontaneous coronary artery dissection (SCAD) typically presents as acute coronary syndrome in young women with no cardiovascular risk factors. It is associated with high morbidity and mortality, and is underdiagnosed. Despite this, risk factors and pathophysiology associated with SCAD are not completely understood. The objective of the present case series was to assess family history as a risk factor in patients with SCAD. Methods: We reviewed the medical records and questionnaires of 335 participants in the Mayo Clinic SCAD Registry for history of MI, SCAD or CAD in another family member. Coronary angiograms of all affected family members were reviewed by a senior interventional cardiologist. Results: We identified 4 familial cases of SCAD comprised of affected mother-daughter, identical twin sister, sister and aunt-niece pairs, implicating both recessive and dominant modes of inheritance. The mother-daughter pair also reported history of fatal MI in 3 maternal relatives including grandmother, great grandmother and great aunt. One of the affected twin sisters died of SCAD, which was confirmed on autopsy. None of the subjects had other potential risk factors for SCAD including extreme exercise, polycystic kidney disease, connective tissue disorder, peripartum status or diagnosed non-coronary fibromuscular dysplasia. The details of their demographics, risk factors, presentation, location of SCAD and management are presented in the table. Conclusions: This series is the first to identify a familial association in SCAD suggesting a genetic predisposition. Recognition of SCAD as a heritable disorder has implications for at-risk family members and furthers our understanding of the pathophysiology of this complex disease. Whole exome sequencing in these families provides a unique opportunity to identify the molecular underpinnings of SCAD susceptibility.

AbstractBackgroundTranscatheter aortic valve‐in‐valve replacement (ViV) has been widely accepted as a less invasive alternative to treat failed aortic surgical or transcatheter bioprosthetic valves. Angulated aortas present an additional challenge, particularly when using self‐expanding transcatheter heart valves (SE‐THV).MethodsTwo patients with failed surgical bioprosthetic aortic valves and one patient with a failed transcatheter bioprosthetic aortic valve underwent transcatheter aortic ViV using SE‐THV. All were deemed high‐risk for surgical aortic valve replacement by a heart team. All three patients had initial failed SE‐THV delivery using a conventional approach with subsequent successful delivery using the endovascular snare technique.ResultsIn Cases 1 and 2, the SE‐THV was biased towards the greater curve of the angulated aorta and behind the outer frame of the bioprosthetic valve frame. An endovascular snare was deployed through a secondary left femoral artery access, and the valve delivery system was advanced through the snare in the ascending aorta. The snare was tightened around the SE‐THV capsule proximal to the hat‐marker, allowing deflection of the SE‐THV and successful delivery. In Case 3, the SE‐THV interacted with the tall frame of a failed SE‐THV. A snare via the left femoral artery was deployed in the descending artery. The SE‐THV was advanced through the snare, and both the snare and SE‐THV were advanced together to the ascending aorta where the SE‐THV was deflected and successfully delivered.ConclusionsThe endovascular snare technique is a feasible option for successful delivery of SE‐THV during transcatheter aortic ViV in failed transcatheter or surgical bioprosthetic valves in angulated aortas.

Objectives The objective was to assess the impact of procedural characteristics on risk of stroke or transient ischaemic attack (TIA) after transcatheter aortic valve replacement (TAVR). Methods We included 370 consecutive patients who underwent balloon-expandable TAVR from 1 November 2008 to 30 June 2014. Procedural characteristics that may be associated with stroke/TIA were assessed. The primary outcome was stroke/TIA at 30 days. A propensity score was constructed using a logistic regression model with 29 parameters. Cox proportional hazards models were used with a propensity score covariate. Results Mean age was 80.9±7.9 years and mean Society of Thoracic Surgeons score was 8.3±5.0. The total number of balloon dilations ranged from 2 to 7. Out of 370 patients, 13 patients (3.5%) suffered stroke/TIA in the first 30 days after TAVR. In univariate analysis, postdeployment balloon dilation (PD) (HR 3.8, 95% CI 1.24 to 11.61; p=0.02) and emergent cardiopulmonary bypass (CPB) (HR 9.66, 95% CI 2.66 to 35.15; p<0.001) were significantly associated with 30-day stroke/TIA. In the multivariable Cox-proportional hazards model, PD (HR 4.95, 95% CI 1.02 to 24.03; p=0.04) and emergent CPB (HR 7.15, 95% CI 1.39 to 36.89; p=0.02) were independently associated with increased risk of 30-day stroke/TIA after adjusting for propensity score, total number of balloon dilations and periprosthetic regurgitation. Conclusion Postdilation as compared with total number of dilations, and emergent CPB were independently associated with increased risk of clinical neurological events in the first 30 days after TAVR. Reduction in balloon postdilation with appropriate valve sizing may reduce the risk of stroke or TIA after TAVR.