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Supplemental material, Presentation 1, for The International Society for Minimally Invasive Cardiothoracic Surgery Expert Consensus Statement on Transcatheter and Surgical Aortic Valve Replacement in Low- and Intermediate-Risk Patients: A Meta-Analysis of Randomized and Propensity-Matched Studies by Vinod H. Thourani, J. James Edelman, Sari D. Holmes, Tom C. Nguyen, John Carroll, Michael J. Mack, Samir Kapadia, Gilbert H. L. Tang, Susheel Kodali, Tsuyoshi Kaneko, Christopher U. Meduri, Jessica Forcillo, Francis D. Ferdinand, Gregory Fontana, Piotr Suwalski, Bob Kiaii, Husam Balkhy, Joerg Kempfert, Anson Cheung, Michael A. Borger, Michael Reardon, Martin B. Leon, Jeffrey J. Popma and Niv Ad in Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery

Supplemental material, Table S1, for The International Society for Minimally Invasive Cardiothoracic Surgery Expert Consensus Statement on Transcatheter and Surgical Aortic Valve Replacement in Low- and Intermediate-Risk Patients: A Meta-Analysis of Randomized and Propensity-Matched Studies by Vinod H. Thourani, J. James Edelman, Sari D. Holmes, Tom C. Nguyen, John Carroll, Michael J. Mack, Samir Kapadia, Gilbert H. L. Tang, Susheel Kodali, Tsuyoshi Kaneko, Christopher U. Meduri, Jessica Forcillo, Francis D. Ferdinand, Gregory Fontana, Piotr Suwalski, Bob Kiaii, Husam Balkhy, Joerg Kempfert, Anson Cheung, Michael A. Borger, Michael Reardon, Martin B. Leon, Jeffrey J. Popma and Niv Ad in Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery

The authors investigated 1-year outcomes after transcaval access and closure for transcatheter aortic valve replacement (TAVR), using commercially available nitinol cardiac occluders off-label.Transcaval access is a fully percutaneous nonfemoral artery route for TAVR. The intermediate-term fate of transcaval access tracts is not known.The authors performed a prospective, multicenter, independently adjudicated trial of transcaval access, using Amplatzer nitinol cardiac occluders (Abbott Vascular, Minneapolis, Minnesota), among subjects without traditional transthoracic (transapical or transaortic) access options. One-year clinical follow-up included core laboratory analysis of serial abdominal computed tomography (CT).100 subjects were enrolled. Twelve-month mortality was 29%. After discharge, there were no vascular complications of transcaval access. Among 83 evaluable CT scans after 12 months, 77 of fistulas (93%) were proven occluded, and only 1 was proven patent. Fistula patency was not associated with overall survival (p = 0.37), nor with heart failure admissions (15% if patent vs. 23% if occluded; p = 0.30). There were no cases of occluder fracture or migration or visceral injury.Results are reassuring 1 year after transcaval TAVR and closure using permeable nitinol occluders off-label. There were no late major vascular complications. CT demonstrated spontaneous closure of almost all fistulas. Results may be different in a lower-risk cohort, with increased operator experience, and using a dedicated transcaval closure device. (Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access; NCT02280824).

The aim of this study was to evaluate whether transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve (S3-TAVR) results in improved quality of life (QoL) compared with previous-generation TAVR devices or surgical aortic valve replacement (SAVR).In patients with severe aortic stenosis at intermediate surgical risk, TAVR using the SAPIEN XT valve (XT-TAVR) results in similar QoL compared with SAVR. Compared with SAPIEN XT, the SAPIEN 3 valve offers a lower delivery profile and modifications to reduce paravalvular regurgitation.Between February and December 2014, 1,078 patients at intermediate surgical risk with severe aortic stenosis were treated with S3-TAVR in the PARTNER S3i (Placement of Aortic Transcatheter Valve) trial. QoL was assessed at baseline, 1 month, and 1 year using the Kansas City Cardiomyopathy Questionnaire, Medical Outcomes Study Short Form-36, and EQ-5D. QoL outcomes of S3-TAVR patients were compared with those in the SAVR and XT-TAVR arms of the PARTNER 2A trial using propensity score stratification to adjust for differences between the treatment groups.Over 1 year, S3-TAVR was associated with substantial improvements in QoL compared with baseline. At 1 month, S3-TAVR was associated with better QoL than either SAVR or XT-TAVR (adjusted differences in Kansas City Cardiomyopathy Questionnaire overall summary score 15.6 and 3.7 points, respectively; p 0.001). At 1 year, the differences in QoL between S3-TAVR and both SAVR and XT-TAVR were reduced but remained statistically significant (adjusted differences 2.0 and 2.2 points, respectively; p 0.05). Similar results were seen for generic QoL outcomes.Among patients at intermediate surgical risk with severe aortic stenosis, S3-TAVR resulted in improved QoL at both 1 month and 1 year compared with both XT-TAVR and SAVR.

OBJECTIVES: This study sought to compare the influence of the extent of multidetector computed tomography (MDCT) area oversizing on the incidence of paravalvular aortic regurgitation (PAR) between the Sapien 3 and the Sapien XT transcatheter heart valve (THV) to define a new MDCT sizing guideline suitable for the Sapien 3 platform.BACKGROUND: The inverse relationship of PAR occurrence and oversizing has been demonstrated for the Sapien XT but the incidence of PAR with comparable oversizing with the Sapien 3 is not known.METHODS: Sixty-one prospectively enrolled patients who underwent transcatheter aortic valve replacement with the Sapien 3 THV were compared with 92 patients who underwent transcatheter aortic valve replacement with the Sapien XT THV. Patients were categorized depending on the degree of MDCT area oversizing percentage: undersizing (below 0%), 0% to 5%, 5% to 10%, and above 10%. The primary endpoint was mild or greater PAR on transthoracic echocardiography.RESULTS: Mild or greater PAR was present in 19.7% of patients (12 of 61) in the Sapien 3 group and in 54.3% of patients (50 of 92) in the Sapien XT group (p < 0.01). The Sapien 3 group, compared with the Sapien XT group, consistently demonstrated significantly lower rates of mild or greater PAR except for oversizing >10% (p for interaction = 0.54). Moderate or severe PAR rates were also lower in the Sapien 3 group than in the Sapien XT group (3.3% vs. 13.0%, p = 0.04). In the Sapien 3 group, a MDCT area oversizing percentage value of ≤4.17% was identified as the optimal cutoff value to discriminate patients with or without mild or greater PAR.CONCLUSIONS: Our retrospective analysis suggests that the Sapien 3 THV displays significantly lower rates of PAR than does the Sapien XT THV. A lesser degree of MDCT area oversizing may be employed for this new balloon-expandable THV.

The goal of this study was to determine whether a less-invasive approach to aortic valve replacement (AVR) improves clinical outcomes in diabetic patients with aortic stenosis (AS).Diabetes is associated with increased morbidity and mortality after surgical AVR for AS.Among treated patients with severe symptomatic AS at high risk for surgery in the PARTNER (Placement of Aortic Transcatheter Valve) trial, we examined outcomes stratified according to diabetes status of patients randomly assigned to receive transcatheter or surgical AVR. The primary outcome was all-cause mortality at 1 year.Among 657 patients enrolled in PARTNER who underwent treatment, there were 275 patients with diabetes (145 transcatheter, 130 surgical). There was a significant interaction between diabetes and treatment group for 1-year all-cause mortality (p = 0.048). Among diabetic patients, all-cause mortality at 1 year was 18.0% in the transcatheter group and 27.4% in the surgical group (hazard ratio: 0.60 [95% confidence interval: 0.36 to 0.99]; p = 0.04). Results were consistent among patients treated via transfemoral or transapical routes. In contrast, among nondiabetic patients, there was no significant difference in all-cause mortality at 1 year (p = 0.48). Among diabetic patients, the 1-year rates of stroke were similar between treatment groups (3.5% transcatheter vs. 3.5% surgery; p = 0.88), but the rate of renal failure requiring dialysis30 days was lower in the transcatheter group (0% vs. 6.1%; p = 0.003).Among patients with diabetes and severe symptomatic AS at high risk for surgery, this post-hoc stratified analysis of the PARTNER trial suggests there is a survival benefit, no increase in stroke, and less renal failure from treatment with transcatheter AVR compared with surgical AVR. (The PARTNER Trial: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).

BackgroundPatients with severe aortic stenosis (AS) who were deemed too high risk or inoperable for conventional aortic valve replacement (AVR) in the PARTNER (Placement of Aortic Transcatheter Valves) trial were randomized to transcatheter aortic valve replacement (TAVR) versus AVR (PARTNER-A arm) or standard therapy (PARTNER-B arm).ObjectivesThis study compared when and how deaths occurred after TAVR versus surgical AVR or standard therapy.MethodsThe PARTNER-A arm included 244 transfemoral (TF) and 104 transapical (TA) TAVR patients, and 351 AVR patients; the PARTNER-B arm included 179 TF-TAVR patients and 179 standard therapy patients. Deaths were categorized as cardiovascular, noncardiovascular, or uncategorizable, and were characterized by multiphase hazard modelling.ResultsIn the PARTNER-A arm, the risk of death peaked after randomization in the TA-TAVR and AVR groups, falling to low levels commensurate with the U.S. population within 3 months. Early risk was less in TF-TAVR patients, resulting in initial superior survival; between 12 and 18 months, risk increased, such that within 2 years, TF-TAVR and AVR patients had similar survival rates. Cardiovascular, noncardiovascular, and uncategorizable deaths for TF-TAVR were 37%, 43%, and 20%, respectively, versus 22%, 41%, and 37%, respectively, for TA-TAVR and 33%, 43%, and 24%, respectively, for AVR. In the PARTNER-B arm, risk with standard therapy was 60% per year; TF-TAVR reduced risk to 20% per year, resulting in 0.5 years of life added within 2.5 years.ConclusionsIn inoperable AS patients, TAVR substantially reduced the risk of cardiovascular death. In high-risk patients, TA-TAVR and AVR were associated with elevated peri-procedural risk more than with TF-TAVR, although cardiovascular death was higher after TF-TAVR. Therefore, TF-TAVR should be considered the standard of care for severely symptomatic inoperable patients or those at high risk of noncardiovascular mortality after conventional surgery. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894)

ObjectivesThis study investigated the determinants and outcomes of acute insertion of a second transcatheter prosthetic valve (TV) within the first (TV-in-TV) or transcatheter valve embolization (TVE) after transcatheter aortic valve replacement (TAVR).BackgroundTAVR failure can occur with both TV-in-TV and TVE as a consequence of TAVR malpositioning. Only case reports and limited series pertaining to these complications have been reported to date.MethodsPatients undergoing TAVR in the PARTNER (Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve) randomized trial (cohorts A and B) and accompanying registries were studied. Data were dichotomized for those with and without TV-in-TV or TVE, respectively.ResultsFrom a total of 2,554 consecutive patients, 63 (2.47%) underwent TV-in-TV and 26 (1.01%) TVE. The indication for TV-in-TV was significant aortic regurgitation in most patients, often due not only to malpositioning but also to leaflet dysfunction. Despite similar aortic valve function on follow-up echoes, TV-in-TV was an independent predictor of 1-year cardiovascular mortality (hazard ratio [HR]: 1.86, 95% confidence interval [CI]: 1.03 to 3.38, p = 0.041), with a nonsignificant trend toward greater all-cause mortality (HR: 1.43, 95% CI: 0.88 to 2.33, p = 0.15). Technical and anatomical reasons accounted for most cases of TVE. A multivariable analysis found TVE to be an independent predictor of 1-year mortality (HR: 2.68, 95% CI: 1.34 to 5.36, p = 0.0055) but not cardiovascular mortality (HR: 1.30, 95% CI: 0.48 to 3.52, p = 0.60).ConclusionsAcute TV-in-TV and TVE are serious sequelae of TAVR, often resulting in multiple valve implants. They carry an excess of mortality and are caused by anatomic and technical factors, which may be avoidable with judicious procedural planning. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894)

Background Little is known about patients with severe symptomatic aortic stenosis (AS) who receive medical management despite evaluation at a heart valve treatment center. Objective We identified patient characteristics associated with medical management, physician-reported reasons for selecting medical management, and patients’ perceptions of their involvement and satisfaction with treatment selection. Methods and results Of 454 patients evaluated for AS at 9 established heart valve treatment centers from December 12, 2013 to August 19, 2014, we included 407 with severe symptomatic AS. Information was collected using medical record review and survey of patients and treating physicians. Of 407 patients, 212 received transcatheter aortic valve replacement (TAVR), 124 received surgical aortic valve replacement (SAVR), and 71 received medical management (no SAVR/TAVR). Thirty-day predicted mortality was higher in patients receiving TAVR (8.7%) or medical management (9.8%) compared with SAVR (3.4%) (P