Examining the typical hemodynamic performance of nearly 3000 modern surgical aortic bioprostheses.

OBJECTIVES: The objective of this analysis was to assess the normal haemodynamic performance of contemporary surgical aortic valves at 1 year postimplant in patients undergoing surgical aortic valve replacement for significant valvular dysfunction. By pooling data from 4 multicentre studies, this study will contribute to a better understanding of the effectiveness of surgical aortic valve replacement procedures, aiding clinicians and researchers in making informed decisions regarding valve selection and patient management. METHODS: Echocardiograms were assessed by a single core laboratory. Effective orifice area, dimensionless velocity index, mean aortic gradient, peak aortic velocity and stroke volume were evaluated. RESULTS: The cohort included 2958 patients. Baseline age in the studies ranged from 70.1 ± 9.0 to 83.3 ± 6.4 years, and Society of Thoracic Surgeons risk of mortality was 1.9 ± 0.7 to 7.5 ± 3.4%. Twenty patients who had received a valve model implanted in fewer than 10 cases were excluded. Ten valve models (all tissue valves; n = 2938 patients) were analysed. At 1 year, population mean effective orifice area ranged from 1.46 ± 0.34 to 2.12 ± 0.59 cm2, and dimensionless velocity index, from 0.39 ± 0.07 to 0.56 ± 0.15. The mean gradient ranged from 8.6 ± 3.4 to 16.1 ± 6.2 mmHg with peak aortic velocity of 1.96 ± 0.39 to 2.65 ± 0.47 m/s. Stroke volume was 75.3 ± 19.6 to 89.8 ± 24.3 ml. CONCLUSIONS: This pooled cohort is the largest to date of contemporary surgical aortic valves with echocardiograms analysed by a single core lab. Overall haemodynamic performance at 1 year ranged from good to excellent. These data can serve as a benchmark for other studies and may be useful to evaluate the performance of bioprosthetic surgical valves over time. CLINICAL TRIAL REGISTRATION NUMBER: NCT02088554, NCT02701283, NCT01586910 and NCT01531374.

Reinterventions After CoreValve/Evolut Transcatheter or Surgical Aortic Valve Replacement for Treatment of Severe Aortic Stenosis.

BACKGROUND: Data on valve reintervention after transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) are limited. OBJECTIVES: The authors compared the 5-year incidence of valve reintervention after self-expanding CoreValve/Evolut TAVR vs SAVR. METHODS: Pooled data from CoreValve and Evolut R/PRO (Medtronic) randomized trials and single-arm studies encompassed 5,925 TAVR (4,478 CoreValve and 1,447 Evolut R/PRO) and 1,832 SAVR patients. Reinterventions were categorized by indication, timing, and treatment. The cumulative incidence of reintervention was compared between TAVR vs SAVR, Evolut vs CoreValve, and Evolut vs SAVR. RESULTS: There were 99 reinterventions (80 TAVR and 19 SAVR). The cumulative incidence of reintervention through 5 years was higher with TAVR vs SAVR (2.2% vs 1.5%; P = 0.017), with differences observed early (≤1 year; adjusted subdistribution HR: 3.50; 95% CI: 1.53-8.02) but not from >1 to 5 years (adjusted subdistribution HR: 1.05; 95% CI: 0.48-2.28). The most common reason for reintervention was paravalvular regurgitation after TAVR and endocarditis after SAVR. Evolut had a significantly lower incidence of reintervention than CoreValve (0.9% vs 1.6%; P = 0.006) at 5 years with differences observed early (adjusted subdistribution HR: 0.30; 95% CI: 0.12-0.73) but not from >1 to 5 years (adjusted subdistribution HR: 0.61; 95% CI: 0.21-1.74). The 5-year incidence of reintervention was similar for Evolut vs SAVR (0.9% vs 1.5%; P = 0.41). CONCLUSIONS: A low incidence of reintervention was observed for CoreValve/Evolut R/PRO and SAVR through 5 years. Reintervention occurred most often at ≤1 year for TAVR and >1 year for SAVR. Most early reinterventions were with the first-generation CoreValve and managed percutaneously. Reinterventions were more common following CoreValve TAVR compared with Evolut TAVR or SAVR.

Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus.

BACKGROUND: Patients with severe aortic stenosis and a small aortic annulus are at risk for impaired valvular hemodynamic performance and associated adverse cardiovascular clinical outcomes after transcatheter aortic-valve replacement (TAVR). METHODS: We randomly assigned patients with symptomatic severe aortic stenosis and an aortic-valve annulus area of 430 mm2 or less in a 1:1 ratio to undergo TAVR with either a self-expanding supraannular valve or a balloon-expandable valve. The coprimary end points, each assessed through 12 months, were a composite of death, disabling stroke, or rehospitalization for heart failure (tested for noninferiority) and a composite end point measuring bioprosthetic-valve dysfunction (tested for superiority). RESULTS: A total of 716 patients were treated at 83 sites in 13 countries (mean age, 80 years; 87% women; mean Society of Thoracic Surgeons Predicted Risk of Mortality, 3.3%). The Kaplan-Meier estimate of the percentage of patients who died, had a disabling stroke, or were rehospitalized for heart failure through 12 months was 9.4% with the self-expanding valve and 10.6% with the balloon-expandable valve (difference, -1.2 percentage points; 90% confidence interval [CI], -4.9 to 2.5; P<0.001 for noninferiority). The Kaplan-Meier estimate of the percentage of patients with bioprosthetic-valve dysfunction through 12 months was 9.4% with the self-expanding valve and 41.6% with the balloon-expandable valve (difference, -32.2 percentage points; 95% CI, -38.7 to -25.6; P<0.001 for superiority). The aortic-valve mean gradient at 12 months was 7.7 mm Hg with the self-expanding valve and 15.7 mm Hg with the balloon-expandable valve, and the corresponding values for additional secondary end points through 12 months were as follows: mean effective orifice area, 1.99 cm2 and 1.50 cm2; percentage of patients with hemodynamic structural valve dysfunction, 3.5% and 32.8%; and percentage of women with bioprosthetic-valve dysfunction, 10.2% and 43.3% (all P<0.001). Moderate or severe prosthesis-patient mismatch at 30 days was found in 11.2% of the patients in the self-expanding valve group and 35.3% of those in the balloon-expandable valve group (P<0.001). Major safety end points appeared to be similar in the two groups. CONCLUSIONS: Among patients with severe aortic stenosis and a small aortic annulus who underwent TAVR, a self-expanding supraannular valve was noninferior to a balloon-expandable valve with respect to clinical outcomes and was superior with respect to bioprosthetic-valve dysfunction through 12 months. (Funded by Medtronic; SMART ClinicalTrials.gov number, NCT04722250.).

Transcatheter or Surgical Aortic Valve Replacement in Women With Small Annuli at Low or Intermediate Surgical Risk.

There are limited data from randomized controlled trials assessing the impact of transcatheter aortic valve replacement (TAVR) or surgery in women with aortic stenosis and small aortic annuli. We evaluated 2-year clinical and hemodynamic outcomes after aortic valve replacement to understand acute valve performance and early and midterm clinical outcomes. This post hoc analysis pooled women enrolled in the randomized, prospective, multicenter Evolut Low Risk and SURTAVI intermediate risk trials. Women with severe aortic stenosis at low or intermediate surgical risk who had a computed tomography-measured annular perimeter of ≤72.3 mm were included and underwent self-expanding, supra-annular TAVR or surgery. The primary end point was 2-year all-cause mortality or disabling stroke rate. The study included 620 women (323 TAVR, 297 surgery) with a mean age of 78 years. At 2 years, the all-cause mortality or disabling stroke was 6.5% for TAVR and 8.0% for surgery, p = 0.47. Pacemaker rates were 20.0% for TAVR and 8.3% for surgery, p <0.001. The mean effective orifice area at 2 years was 1.9 ± 0.5 cm2 for TAVR and 1.6 ± 0.5 cm2 for surgery and the mean gradient was 8.0 ± 4.1 versus 12.7 ± 6.0 mm Hg, respectively (both p <0.001). Moderate or severe patient-prothesis mismatch at discharge occurred in 10.9% of patients who underwent TAVR and 33.2% of patients who underwent surgery, p <0.001. In conclusion, in women with small annuli, the clinical outcomes to 2 years were similar between self-expanding, supra-annular TAVR and surgery, with better hemodynamics in the TAVR group and fewer pacemakers in the surgical group.

Quality of Life 5 Years Following Transfemoral TAVR or SAVR in Intermediate Risk Patients.

BACKGROUND: Symptomatic patients with severe aortic stenosis (AS) at high risk for surgical aortic valve replacement (SAVR) sustain comparable improvements in health status over 5 years after transcatheter aortic valve replacement (TAVR) or SAVR. Whether a similar long-term benefit is observed among intermediate-risk AS patients is unknown. OBJECTIVES: The purpose of this study was to assess health status outcomes through 5 years in intermediate risk patients treated with a self-expanding TAVR prosthesis or SAVR using data from the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial. METHODS: Intermediate-risk patients randomized to transfemoral TAVR or SAVR in the SURTAVI trial had disease-specific health status assessed at baseline, 30 days, and annually to 5 years using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Health status was compared between groups using fixed effects repeated measures modelling. RESULTS: Of the 1,584 patients (TAVR, n = 805; SAVR, n = 779) included in the analysis, health status improved more rapidly after TAVR compared with SAVR. However, by 1 year, both groups experienced large health status benefits (mean change in KCCQ-Overall Summary Score (KCCQ-OS) from baseline: TAVR: 20.5 ± 22.4; SAVR: 20.5 ± 22.2). This benefit was sustained, albeit modestly attenuated, at 5 years (mean change in KCCQ-OS from baseline: TAVR: 15.4 ± 25.1; SAVR: 14.3 ± 24.2). There were no significant differences in health status between the cohorts at 1 year or beyond. Similar findings were observed in the KCCQ subscales, although a substantial attenuation of benefit was noted in the physical limitation subscale over time in both groups. CONCLUSIONS: In intermediate-risk AS patients, both transfemoral TAVR and SAVR resulted in comparable and durable health status benefits to 5 years. Further research is necessary to elucidate the mechanisms for the small decline in health status noted at 5 years compared with 1 year in both groups. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement [SURTAVI]; NCT01586910).

Renal Dysfunction at Discharge and Long-Term Survival in Acute Type A Aortic Dissection.

INTRODUCTION: We aimed to investigate the association between renal dysfunction at discharge and long-term survival in acute type A aortic dissection (ATAAD) patients following surgery. METHODS: From 2000 to 2021, 784 patients underwent aortic repair for an ATAAD. Patients were stratified based on creatinine (Cr) level at discharge alive or dead: normal Cr (n = 582) and elevated Cr defined as >1.3 mg/dL for males and >1.0 mg/dL for females or on dialysis at discharge (n = 202). RESULTS: Preoperatively, both groups had similar rates of comorbidities except for the elevated-Cr group which had more diabetes, chronic obstructive pulmonary disease, and chronic and acute renal insufficiency. Both groups had similar open ATAAD repair procedures. Postoperative outcomes in the elevated-Cr group were significantly worse, including six times higher operative mortality (20% versus 3.4%, P < 0.0001). The landmark long-term survival after discharge alive was significantly worse in the elevated-Cr group than the normal-Cr group (10-y survival: 48% versus 69%, P = 0.0009). The elevated Cr on dialysis at discharge group had significantly worse five-year survival (40%) than the elevated Cr not on dialysis at discharge group (80%, P = 0.02) and the normal-Cr group (87%, P < 0.0001). Additionally, the elevated Cr not on dialysis had a worse five-year survival than the normal-Cr group (80% versus 87%, P = 0.02). Elevated Cr at discharge on dialysis was a significant risk factor for late mortality (hazard ratio = 4.22, 95% confidence interval: [2.07, 8.61], P < 0.0001). CONCLUSIONS: Renal dysfunction at discharge was associated with significantly decreased short-term and long-term survival following open ATAAD repair. Surgeons should aggressively prevent renal dysfunction, especially new-onset dialysis, at discharge as it is correlated with significantly worse short-term and long-term outcomes.

Acute type A intramural hematoma: The less-deadly acute aortic syndrome?

OBJECTIVE: To evaluate the short- and midterm outcomes of surgically managed acute type A intramural hematoma (IMH) versus classic acute type A aortic dissection (ATAAD). METHODS: From 1996 to February 2023, a total of 106 patients with acute type A IMH and 795 patients with classic ATAAD presented for open aortic repair at our institution. Data were obtained from the local Society of Thoracic Surgeons' Data Warehouse and medical chart review. RESULTS: Compared with the classic ATAAD group, the IMH group was older (65 vs 59 years, P < .001) and more likely to be female (45% vs 32%, P = .005), with fewer comorbidities such as severe aortic insufficiency (5.0% vs 25%, P < .001), acute stroke (2.8% vs 8.3%, P = .05), acute renal failure (5.7% vs 13%, P = .04), and malperfusion syndrome (8.5% vs 26%, P < .001) but more cardiac tamponade (18% vs 11%, P = .03). The IMH group had less aortic root replacement (15% vs 33%, P < .001), zone 2 arch replacements (9.4% vs 18%, P = .02), and shorter crossclamp times (120 minutes vs 150 minutes, P < .001). The operative mortality was significantly lower in the IMH group (0.9% vs 8.8%, P = .005) and a multivariable regression model showed IMH to be protective, odds ratio of 0.11, P = .03. The 10-year survival was similar between the 2 groups (65% vs 61%, P = .35). The hazard ratio of IMH for midterm mortality after surgery was 0.73, P = .12. CONCLUSIONS: Acute type A IMH could be treated with emergency open aortic repair with excellent short- and midterm outcomes.

Five-Year Follow-Up from the CoreValve Expanded Use Transcatheter Aortic Valve-in-Surgical Aortic Valve Study.

Transcatheter aortic valve replacement (TAVR) provides an option for extreme-risk patients who underwent reoperation for a failed surgical aortic bioprosthesis. Long-term data on patients who underwent TAVR within a failed surgical aortic valve (TAV-in-SAV) are limited. The CoreValve Expanded Use Study evaluated patients at extreme surgical risk who underwent TAV-in-SAV. Outcomes at 5 years were analyzed by SAV failure mode (stenosis, regurgitation, or combined). Echocardiographic outcomes are site-reported. TAV-in-SAV was attempted in 226 patients with a mean age of 76.7 ± 10.8 years; 63.3% were male, the Society of Thoracic Surgeons predicted risk of mortality score was 9.0 ± 6.7%, and 87.5% had a New York Heart Association classification III or IV symptoms. Most of the failed surgical bioprostheses were stented (81.9%), with an average implant duration of 10.2 ± 4.3 years. The 5-year all-cause mortality or major stroke rate was 47.2% in all patients; 54.4% in the stenosis, 37.6% in the regurgitation, and 38.0% in the combined groups (p = 0.046). At 5 years, all-cause mortality was higher in patients with versus without 30-day severe prosthesis-patient mismatch (51.7% vs 38.3%, p = 0.026). The overall aortic valve reintervention rate was 5.9%; highest in the regurgitation group (12.6%). The mean aortic valve gradient was 14.1 ± 9.8 mm Hg and effective orifice area was 1.57 ± 0.70 at 5 years. Few patients had >mild paravalvular regurgitation at 5 years (5.5% moderate, 0.0% severe). TAV-in-SAV with supra-annular, self-expanding TAVR continues to represent a safe and lasting intermediate option for extreme-risk patients who have appropriate sizing of the preexisting failed surgical valve. Clinical and hemodynamic outcomes were stable through 5 years.

Progression of distal aorta after endovascular fenestration/stenting in acute type A aortic dissection with malperfusion syndrome.

Objective: The study objective was to evaluate the progression of dissected distal aorta in patients with acute type A aortic dissection with malperfusion syndrome treated with endovascular fenestration/stenting and delayed open aortic repair. Methods: From 1996 to 2021, 927 patients presented with acute type A aortic dissection. Of these, 534 had DeBakey I dissection with no malperfusion syndrome and underwent emergency open aortic repair (no malperfusion syndrome group), whereas 97 patients with malperfusion syndrome underwent fenestration/stenting and delayed open aortic repair (malperfusion syndrome group). Sixty-three patients with malperfusion syndrome treated with fenestration/stenting were excluded due to no open aortic repair, including death from organ failure (n = 31), death from aortic rupture (n = 16), and discharged alive (n = 16). Results: Compared with the no malperfusion syndrome group, the malperfusion syndrome group had more patients with acute renal failure (60% vs 4.3%, P < .001). Both groups had similar aortic root and arch procedures. Postoperatively, the malperfusion syndrome group had similar operative mortality (5.2% vs 7.9%, P = .35) and permanent dialysis (4.7% vs 2.9%, P = .50), but more new-onset dialysis (22% vs 7.7%, P < .001) and prolonged ventilation (72% vs 49%, P < .001). The growth rate of the aortic arch (0.38 vs 0.35 mm/year, P = .81) was similar between the malperfusion syndrome and no malperfusion syndrome groups. The descending thoracic aorta growth rate (1.03 vs 0.68 mm/year, P = .001) and abdominal aorta growth rate (0.76 vs 0.59 mm/year, P = .02) were significantly higher in the malperfusion syndrome group. The cumulative incidence of reoperation over 10 years (18% vs 18%, P = .81) and 15-year survival outcome (50% vs 48%, P = .43) were similar between the malperfusion syndrome and no malperfusion syndrome groups. Conclusions: Endovascular fenestration/stenting followed by delayed open aortic repair was a valid approach for patients with malperfusion syndrome.

Predicting 5-Year Clinical Outcomes After Transcatheter or Surgical Aortic Valve Replacement (a Risk Score from the SURTAVI Trial).

Risk prediction scores for long-term outcomes after transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) are lacking. This study aimed to develop preprocedural risk scores for 5-year clinical outcomes after TAVI or SAVR. This analysis included 1,660 patients at an intermediate surgical risk with severe aortic stenosis randomly assigned to TAVI (n = 864) or SAVR (n = 796) from the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial. The primary end point was a composite of all-cause mortality or disabling stroke at 5 years. The secondary end point was a composite of cardiovascular mortality or hospitalizations for valve disease or worsening heart failure at 5 years. Preprocedural multivariable predictors of clinical outcomes were used to calculate a simple risk score for both procedures. At 5 years, the primary end point occurred in 31.3% of the patients with TAVI and 30.8% of the patients with SAVR. Preprocedural predictors differed between TAVI and SAVR. Baseline anticoagulant use was a common predictor for events in both procedures, whereas male sex and a left ventricular ejection fraction <60% were significant predictors for events in patients with TAVI and SAVR, respectively. A total of 4 simple scoring systems were created based on these multivariable predictors. The C-statistics of all models were modest but performed better than the contemporary risk scores. In conclusion, preprocedural predictors of events differ between TAVI and SAVR, necessitating separate risk models. Despite the modest predictive value of the SURTAVI risk scores, they appeared superior to other contemporary scores. Further research is needed to strengthen and validate our risk scores, possibly by including biomarker and echocardiographic parameters.

Reoperation following transcatheter aortic valve replacement: Insights from 10 years' experience.

OBJECTIVE: Use of transcatheter aortic valve replacement (TAVR) has demonstrated dramatic growth in the past decade. This study aims to investigate implications of post-TAVR reoperation from our 10-year experience. METHODS: Between 2011 and 2022, 66 post-TAVR patients underwent a reoperation, consisting of 42 (63.6%) patients with native TAVR and 24 (36.4%) patients with valve-in-valve TAVR (VIV-TAVR) after surgical aortic valve replacement. RESULTS: The aggregate proportion of patients belonging to the low-/intermediate-risk group at the time of TAVR exceeded that of the high-/extreme-risk cohort in 2021. The native TAVR group received a larger TAVR valve, whereas more frequent low-risk status at the time of TAVR than the VIV-TAVR group. Concurrent procedures were highly common during reoperation and isolated surgical aortic valve replacement represented only 18.2% of the entire cohort. The native TAVR group demonstrated significantly higher TAVR explant difficulty index score (2.0 vs 1.0 points; P < .001) and operative mortality (14.2% vs 0%; P = .079) compared with the VIV-TAVR group. The 8-year cumulative incidence of reoperation was 1.9% and 14.1% (subdistribution hazard ratio, 8.0; 95% CI, 4.1-15.9; P < .001) in the native and VIV-TAVR group, respectively. Furthermore, cumulative incidence of valve reintervention, combining reoperations and redo TAVRs, was 3.3% and 19.0% (subdistribution hazard ratio, 6.2; 95% CI, 3.6-10.9; P < .001). CONCLUSIONS: Low-/intermediate-risk patients are emerging as the predominant group necessitating reoperations. Native TAVR was associated with lower postimplant reintervention rates, albeit with higher reoperative technical difficulty and mortality. Conversely, VIV-TAVR was associated with higher reintervention, but demonstrated lower technical difficulty and mortality for reoperation.

Feasibility of redo-TAVI in self-expanding Evolut valves: a CT analysis from the Evolut Low Risk Trial substudy.

BACKGROUND: Transcatheter aortic valve implantation in an existing transcatheter valve (redo-TAVI) pins the index valve leaflets in the open position (neoskirt), which can cause coronary flow compromise and limit access. Whether anatomy may preclude redo-TAVI in self-expanding Evolut valves is unknown. AIMS: We aimed to evaluate the anatomical feasibility of redo-TAVI by simulating implantation of a balloon-expandable SAPIEN 3 (S3) within an Evolut or an Evolut within an Evolut. METHODS: A total of 204 post-TAVI computed tomography (CT) scans from the Evolut Low Risk CT substudy were analysed. Five redo-TAVI positions were evaluated: S3-in-Evolut inflow-to-inflow, S3 outflow at Evolut nodes 4, 5, and 6, and Evolut-in-Evolut inflow-to-inflow. Univariable modelling identified pre-TAVI clinical characteristics, CT anatomical parameters, and procedural variables associated with coronary flow compromise using the neoskirt height and post-TAVI aortic root dimensions. RESULTS: The risk of coronary flow compromise was lowest when the S3 outflow was at Evolut node 4 (20%) and highest when at Evolut node 6 (75%). The highest likelihood of preserving coronary accessibility occurred with the S3 outflow at Evolut node 4. Female sex and higher body mass index were associated with a higher risk of coronary flow compromise, as were a smaller annulus diameter, lower sinus of Valsalva height and width, shorter coronary height, smaller sinotubular junction diameter, and shallower Evolut implant depth. CONCLUSIONS: The feasibility of redo-TAVI after Evolut failure is multifactorial and relates to the native annular anatomy, as well as the implantation depth of the index and second bioprostheses. Placement of an S3 at a lower Evolut position may reduce the risk of coronary flow compromise while preserving coronary access. CLINICALTRIALS: gov: NCT02701283.

Redo Surgical Aortic Valve Replacement After Prior Transcatheter Versus Surgical Aortic Valve Replacement.

BACKGROUND: Aortic stenosis treatment should consider risks and benefits for lifetime management. Although the feasibility of redo transcatheter aortic valve replacement (TAVR) remains unclear, concerns are emerging regarding reoperation after TAVR. OBJECTIVES: The authors sought to define comparative risk of surgical aortic valve replacement (SAVR) after prior TAVR or SAVR. METHODS: Data on patients undergoing bioprosthetic SAVR after TAVR and/or SAVR were extracted from the Society of Thoracic Surgeons Database (2011-2021). Overall and isolated SAVR cohorts were analyzed. The primary outcome was operative mortality. Risk adjustment using hierarchical logistic regression as well as propensity score matching for isolated SAVR cases were performed. RESULTS: Of 31,106 SAVR patients, 1,126 had prior TAVR (TAVR-SAVR), 674 had prior SAVR and TAVR (SAVR-TAVR-SAVR), and 29,306 had prior SAVR (SAVR-SAVR). Yearly rates of TAVR-SAVR and SAVR-TAVR-SAVR increased over time, whereas SAVR-SAVR was stable. The TAVR-SAVR patients were older, with higher acuity, and with greater comorbidities than other cohorts. The unadjusted operative mortality was highest in the TAVR-SAVR group (17% vs 12% vs 9%, respectively; P < 0.001). Compared with SAVR-SAVR, risk-adjusted operative mortality was significantly higher for TAVR-SAVR (OR: 1.53; P = 0.004), but not SAVR-TAVR-SAVR (OR: 1.02; P = 0.927). After propensity score matching, operative mortality of isolated SAVR was 1.74 times higher for TAVR-SAVR than SAVR-SAVR patients (P = 0.020). CONCLUSIONS: The number of post-TAVR reoperations is increasing and represent a high-risk population. Yet even in isolated SAVR cases, SAVR after TAVR is independently associated with increased risk of mortality. Patients with life expectancy beyond a TAVR valve and unsuitable anatomy for redo-TAVR should consider a SAVR-first approach.

Prosthetic Valve Endocarditis After Transcatheter and Surgical Aortic Valve Replacement.

BACKGROUND: Prosthetic valve endocarditis (PVE) is a devastating sequela of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). However, reoperation for post-TAVR PVE is not well described. We investigated the implications of surgically managed PVE after TAVR and SAVR. METHODS: Reoperations for active PVE after TAVR and SAVR from 2011 to 2021 were queried using The Society of Thoracic Surgeons (STS) database. We identified 6257 patients, consisting of 374 TAVR (6%) and 5883 SAVR recipients (94%). RESULTS: Post-TAVR case volume increased from 1 in 2011 to 116 in 2020. Compared with SAVR, the TAVR group was associated with older age, more frequent preexisting pacemaker, and fewer aortic root abscesses. Intraoperatively, TAVR patients received less aortic root repair (24.9% vs 34.8%; P < .001) and had shorter cardiopulmonary bypass/aortic cross-clamp times. Among all comers, the operative mortality in patients with previous was 13.6% for TAVR vs 10.8% for SAVR (P = .088). After risk adjustment, previous TAVR itself was not associated with operative mortality (odds ratio, 0.99; 95% CI, 0.72-1.38). In contrast, among 154 post-TAVR and 2232 post-SAVR patients with STS-indexed procedures (SAVR ± coronary artery bypass grafting) with available STS predicted risk of mortality, the mortality was 14.3% and 7.9% (P = .005), with corresponding observed-to-expected mortality ratio of 2.2 and 1.3, respectively. CONCLUSIONS: Aortic root repair was seen less frequently after TAVR than after SAVR. Furthermore, previous TAVR was not associated with increased operative mortality. In contrast, the post-TAVR setting was associated with higher mortality regarding isolated SAVR or SAVR plus coronary artery bypass grafting.

3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis.

BACKGROUND: Randomized data comparing outcomes of transcatheter aortic valve replacement (TAVR) with surgery in low-surgical risk patients at time points beyond 2 years is limited. This presents an unknown for physicians striving to educate patients as part of a shared decision-making process. OBJECTIVES: The authors evaluated 3-year clinical and echocardiographic outcomes from the Evolut Low Risk trial. METHODS: Low-risk patients were randomized to TAVR with a self-expanding, supra-annular valve or surgery. The primary endpoint of all-cause mortality or disabling stroke and several secondary endpoints were assessed at 3 years. RESULTS: There were 1,414 attempted implantations (730 TAVR; 684 surgery). Patients had a mean age of 74 years and 35% were women. At 3 years, the primary endpoint occurred in 7.4% of TAVR patients and 10.4% of surgery patients (HR: 0.70; 95% CI: 0.49-1.00; P = 0.051). The difference between treatment arms for all-cause mortality or disabling stroke remained broadly consistent over time: -1.8% at year 1; -2.0% at year 2; and -2.9% at year 3. The incidence of mild paravalvular regurgitation (20.3% TAVR vs 2.5% surgery) and pacemaker placement (23.2% TAVR vs 9.1% surgery; P < 0.001) were lower in the surgery group. Rates of moderate or greater paravalvular regurgitation for both groups were <1% and not significantly different. Patients who underwent TAVR had significantly improved valve hemodynamics (mean gradient 9.1 mm Hg TAVR vs 12.1 mm Hg surgery; P < 0.001) at 3 years. CONCLUSIONS: Within the Evolut Low Risk study, TAVR at 3 years showed durable benefits compared with surgery with respect to all-cause mortality or disabling stroke. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283).

Valve-Sparing Aortic Root Replacement Technique: Valsalva Graft versus Two Straight Tubular Grafts.

Background: There are many variations in valve-sparing aortic root replacement techniques. Our aim is to determine the impact of the graft on mid-term outcomes: Valsalva graft vs. two straight tubular grafts. Methods: From 2004 to 2020, 332 patients underwent valve-sparing aortic root replacement with either a Valsalva graft (Valsalva group: n = 270) or two straight tubular grafts (two-graft group: n = 62). Data were obtained through chart review and the National Death Index. Primary outcomes were mid-term survival and freedom from reoperation. Results: The preoperative characteristics of the groups were similar, but the two-graft group had more type A dissections (32% vs. 19%) and emergent operations (26% vs. 15%) and was younger (45 vs. 50 years). Intraoperatively, the groups were similar, but the two-graft group had longer cross-clamp (245 vs. 215 minutes) and cardiopulmonary bypass times (284 vs. 255 minutes). Postoperative complications including reoperation for bleeding, stroke, pacemaker implantation, and renal failure were slightly more frequent in the Valsalva group, but the differences were not significant. Operative mortality was similar between the Valsalva and two-graft groups (0.7% vs. 0%). Five-year survival in the two-graft group was 100% compared to 96% in the Valsalva group (p=0.56). Five-year freedom from reoperation in the two-graft group was 100% compared to 93% in the Valsalva group (p=0.29). Conclusions: The Valsalva and two-graft techniques both have excellent short- and mid-term outcomes. The two-graft technique might have slightly better survival and freedom from reoperation, but a larger sample size and longer follow-up are needed to determine if these advantages are significant.

The Relationship Between Hospital Stroke Center Designation and TVT Reported Stroke: The Michigan TAVR Experience.

BACKGROUND: The 30-day rate of stroke after transcatheter aortic valve replacement (TAVR) has been suggested as a hospital quality metric. Thirty-day stroke rates for nonsurgical, high, and moderate-risk TAVR trials were 3.4% to 6.1%, whereas those in the national Transcatheter Valve Therapy (TVT) Registry for the same patient population were much lower. Hospital comprehensive stroke center (CSC) is the highest designation for integrated acute stroke recognition, management, and care. OBJECTIVES: Using Michigan TVT data, we assessed whether in-hospital post-TAVR stroke rates varied between CSC and non-CSC institutions. METHODS: TVT data submitted from the 22 Michigan Transcatheter Aortic Valve Replacement Collaborative participating institutions between January 1, 2016, and June 30, 2019, were included (N = 6,231). Bayesian hierarchical regression models accounting for patient clinical characteristics and hospital clustering were fitted to assess the association between hospital CSC accreditation and in-hospital post-TAVR stroke. Adjusted ORs and 95% credible intervals were estimated. The University of Michigan Institutional Review Board has waived the need for the approval of studies based on the data collected by the Blue Cross Blue Shield of Michigan Cardiovascular Consortium registry. RESULTS: There were 3,882 (62.3%) patients at 9 CSC sites and 2,349 (37.7%) patients at 13 non-CSC sites. CSC sites had significantly higher rates of in-hospital post-TAVR stroke (CSC: 2.65% vs non-CSC: 1.15%; P < 0.001). After adjustment, patients who underwent TAVR at a CSC hospital had a significantly higher risk of in-hospital stroke (adjusted OR: 2.21; 95% CI: 1.03-4.62). However, CSC designation was not significantly associated with other important post-TAVR clinical outcomes including 30-day mortality. CONCLUSIONS: Reported Michigan Transcatheter Aortic Valve Replacement Collaborative TVT stroke rates were significantly higher at sites with Joint Hospital Commission stroke designation status; however, other reported important clinical outcomes did not differ significantly based on this designation. CSC designation is a possible factor in stroke rate detection differences between TAVR institutions and might be a factor in the observed differences in stroke rates between TAVR trials and those reported in TVT. In addition, these data suggest that comparison between hospitals based on post-TAVR stroke rates is potentially problematic.