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.).

Regulatory variants in TCF7L2 are associated with thoracic aortic aneurysm.

Thoracic aortic aneurysm (TAA) is characterized by dilation of the aortic root or ascending/descending aorta. TAA is a heritable disease that can be potentially life threatening. While 10%-20% of TAA cases are caused by rare, pathogenic variants in single genes, the origin of the majority of TAA cases remains unknown. A previous study implicated common variants in FBN1 with TAA disease risk. Here, we report a genome-wide scan of 1,351 TAA-affected individuals and 18,295 control individuals from the Cardiovascular Health Improvement Project and Michigan Genomics Initiative at the University of Michigan. We identified a genome-wide significant association with TAA for variants within the third intron of TCF7L2 following replication with meta-analysis of four additional independent cohorts. Common variants in this locus are the strongest known genetic risk factor for type 2 diabetes. Although evidence indicates the presence of different causal variants for TAA and type 2 diabetes at this locus, we observed an opposite direction of effect. The genetic association for TAA colocalizes with an aortic eQTL of TCF7L2, suggesting a functional relationship. These analyses predict an association of higher expression of TCF7L2 with TAA disease risk. In vitro, we show that upregulation of TCF7L2 is associated with BCL2 repression promoting vascular smooth muscle cell apoptosis, a key driver of TAA disease.

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.

Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients.

BACKGROUND: Transcatheter aortic-valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis who are at increased risk for death from surgery; less is known about TAVR in low-risk patients. METHODS: We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic-valve replacement in patients who had severe aortic stenosis and were at low surgical risk. When 850 patients had reached 12-month follow-up, we analyzed data regarding the primary end point, a composite of death or disabling stroke at 24 months, using Bayesian methods. RESULTS: Of the 1468 patients who underwent randomization, an attempted TAVR or surgical procedure was performed in 1403. The patients' mean age was 74 years. The 24-month estimated incidence of the primary end point was 5.3% in the TAVR group and 6.7% in the surgery group (difference, -1.4 percentage points; 95% Bayesian credible interval for difference, -4.9 to 2.1; posterior probability of noninferiority >0.999). At 30 days, patients who had undergone TAVR, as compared with surgery, had a lower incidence of disabling stroke (0.5% vs. 1.7%), bleeding complications (2.4% vs. 7.5%), acute kidney injury (0.9% vs. 2.8%), and atrial fibrillation (7.7% vs. 35.4%) and a higher incidence of moderate or severe aortic regurgitation (3.5% vs. 0.5%) and pacemaker implantation (17.4% vs. 6.1%). At 12 months, patients in the TAVR group had lower aortic-valve gradients than those in the surgery group (8.6 mm Hg vs. 11.2 mm Hg) and larger effective orifice areas (2.3 cm2 vs. 2.0 cm2). CONCLUSIONS: In patients with severe aortic stenosis who were at low surgical risk, TAVR with a self-expanding supraannular bioprosthesis was noninferior to surgery with respect to the composite end point of death or disabling stroke at 24 months. (Funded by Medtronic; ClinicalTrials.gov number, NCT02701283.).

Comparison of a Complete Percutaneous Versus Surgical Approach to Aortic Valve Replacement and Revascularization in Patients at Intermediate Surgical Risk: Results From the Randomized SURTAVI Trial.

BACKGROUND: For patients with severe aortic stenosis and coronary artery disease, the completely percutaneous approach to aortic valve replacement and revascularization has not been compared with the standard surgical approach. METHODS: The prospective SURTAVI trial (Safety and Efficiency Study of the Medtronic CoreValve System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement) enrolled intermediate-risk patients with severe aortic stenosis from 87 centers in the United States, Canada, and Europe between June 2012 and June 2016. Complex coronary artery disease with SYNTAX score (Synergy Between PCI with Taxus and Cardiac Surgery Trial) >22 was an exclusion criterion. Patients were stratified according to the need for revascularization and then randomly assigned to treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Patients assigned to revascularization in the TAVR group underwent percutaneous coronary intervention, whereas those in the SAVR group had coronary artery bypass grafting. The primary end point was the rate of all-cause mortality or disabling stroke at 2 years. RESULTS: Of 1660 subjects with attempted aortic valve implants, 332 (20%) were assigned to revascularization. They had a higher Society of Thoracic Surgeons risk score for mortality (4.8±1.7% versus 4.4±1.5%; P<0.01) and were more likely to be male (65.1% versus 54.2%; P<0.01) than the 1328 patients not assigned to revascularization. After randomization to treatment, there were 169 patients undergoing TAVR and percutaneous coronary intervention, 163 patients undergoing SAVR and coronary artery bypass grafting, 695 patients undergoing TAVR, and 633 patients undergoing SAVR. No significant difference in the rate of the primary end point was found between TAVR and percutaneous coronary intervention and SAVR and coronary artery bypass grafting (16.0%; 95% CI, 11.1-22.9 versus 14.0%; 95% CI, 9.2-21.1; P=0.62), or between TAVR and SAVR (11.9%; 95% CI, 9.5-14.7 versus 12.3%; 95% CI, 9.8-15.4; P=0.76). CONCLUSIONS: For patients at intermediate surgical risk with severe aortic stenosis and noncomplex coronary artery disease (SYNTAX score ≤22), a complete percutaneous approach of TAVR and percutaneous coronary intervention is a reasonable alternative to SAVR and coronary artery bypass grafting. CLINICAL TRIAL REGISTRATION: URL: https://www. CLINICALTRIALS: gov. Unique identifier: NCT01586910.

Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients.

BACKGROUND: Although transcatheter aortic-valve replacement (TAVR) is an accepted alternative to surgery in patients with severe aortic stenosis who are at high surgical risk, less is known about comparative outcomes among patients with aortic stenosis who are at intermediate surgical risk. METHODS: We evaluated the clinical outcomes in intermediate-risk patients with severe, symptomatic aortic stenosis in a randomized trial comparing TAVR (performed with the use of a self-expanding prosthesis) with surgical aortic-valve replacement. The primary end point was a composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic-valve replacement. We used Bayesian analytical methods (with a margin of 0.07) to evaluate the noninferiority of TAVR as compared with surgical valve replacement. RESULTS: A total of 1746 patients underwent randomization at 87 centers. Of these patients, 1660 underwent an attempted TAVR or surgical procedure. The mean (±SD) age of the patients was 79.8±6.2 years, and all were at intermediate risk for surgery (Society of Thoracic Surgeons Predicted Risk of Mortality, 4.5±1.6%). At 24 months, the estimated incidence of the primary end point was 12.6% in the TAVR group and 14.0% in the surgery group (95% credible interval [Bayesian analysis] for difference, -5.2 to 2.3%; posterior probability of noninferiority, >0.999). Surgery was associated with higher rates of acute kidney injury, atrial fibrillation, and transfusion requirements, whereas TAVR had higher rates of residual aortic regurgitation and need for pacemaker implantation. TAVR resulted in lower mean gradients and larger aortic-valve areas than surgery. Structural valve deterioration at 24 months did not occur in either group. CONCLUSIONS: TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk, with a different pattern of adverse events associated with each procedure. (Funded by Medtronic; SURTAVI ClinicalTrials.gov number, NCT01586910 .).

Endovascular Fenestration/Stenting First Followed by Delayed Open Aortic Repair for Acute Type A Aortic Dissection With Malperfusion Syndrome.

BACKGROUND: Immediate open repair of acute type A aortic dissection is traditionally recommended to prevent death from aortic rupture. However, organ failure because of malperfusion syndrome (MPS) might be the most imminent life-threatening problem for a subset of patients. METHODS: From 1996 to 2017, among 597 patients with acute type A aortic dissection, 135 patients with MPS were treated with upfront endovascular reperfusion (fenestration/stenting) followed by delayed open repair (OR). We compared outcomes between the first and second decades and observed mortalities with those expected with an "upfront OR for every patient" approach, determined using prognostic models from the literature (Verona, Leipzig-Halifax, Stockholm, Penn, and GERAADA [German Registry for Acute Aortic Dissection Type A] models). RESULTS: Overall, in-hospital mortality improved between the 2 decades (21.0% versus 10.7%, P<0.001). In the second decade, for patients with MPS initially treated with fenestration/stenting, mortality from aortic rupture decreased from 16% to 4% ( P=0.05), the risk of dying from organ failure was 6.6 times higher than dying from aortic rupture (hazard ratio=6.63; 95% CI, 1.5-29; P=0.01), and 30-day mortality after OR for MPS patients was 3.7%. Compared to the expected mortalities with the upfront OR for every patient models, our observed 30-day and in-hospital mortalities (9% and 11%, respectively) of all patients with acute type A aortic dissection were significantly lower ( P≤0.03). CONCLUSIONS: Immediate OR is the strategy to prevent death from aortic rupture for the majority of patients with acute type A aortic dissection. However, relatively stable (no rupture, no tamponade) patients with MPS benefit from a staged approach: upfront endovascular reperfusion followed by aortic OR at resolution of organ failure.

Transcatheter aortic-valve replacement with a self-expanding prosthesis.

BACKGROUND: We compared transcatheter aortic-valve replacement (TAVR), using a self-expanding transcatheter aortic-valve bioprosthesis, with surgical aortic-valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery. METHODS: We recruited patients with severe aortic stenosis who were at increased surgical risk as determined by the heart team at each study center. Risk assessment included the Society of Thoracic Surgeons Predictor Risk of Mortality estimate and consideration of other key risk factors. Eligible patients were randomly assigned in a 1:1 ratio to TAVR with the self-expanding transcatheter valve (TAVR group) or to surgical aortic-valve replacement (surgical group). The primary end point was the rate of death from any cause at 1 year, evaluated with the use of both noninferiority and superiority testing. RESULTS: A total of 795 patients underwent randomization at 45 centers in the United States. In the as-treated analysis, the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group (14.2% vs. 19.1%), with an absolute reduction in risk of 4.9 percentage points (upper boundary of the 95% confidence interval, -0.4; P<0.001 for noninferiority; P = 0.04 for superiority). The results were similar in the intention-to-treat analysis. In a hierarchical testing procedure, TAVR was noninferior with respect to echocardiographic indexes of valve stenosis, functional status, and quality of life. Exploratory analyses suggested a reduction in the rate of major adverse cardiovascular and cerebrovascular events and no increase in the risk of stroke. CONCLUSIONS: In patients with severe aortic stenosis who are at increased surgical risk, TAVR with a self-expanding transcatheter aortic-valve bioprosthesis was associated with a significantly higher rate of survival at 1 year than surgical aortic-valve replacement. (Funded by Medtronic; U.S. CoreValve High Risk Study ClinicalTrials.gov number, NCT01240902.).

A 20-year experience with thoracic endovascular aortic repair.

BACKGROUND: Endovascular approaches (thoracic endovascular aortic repair) have revolutionized treatment of thoracic aortic disease. OBJECTIVE: We report our 20-year experience with this therapy. METHODS: Four hundred twenty patients (mean age = 69.0 years; 54% male) underwent thoracic endovascular aortic repair (1993-2013), predominantly for fusiform aneurysm (n = 144), saccular aneurysm (n = 94), acute (n = 64) or chronic (n = 36) dissection, or traumatic injury (n = 39). Rupture was present in 80 patients (19.1%). Most patients (78.3%) were at high risk for open repair. Mean aortic diameter was 5.5 cm. Extent of repair included arch in 218 patients, total descending aorta in 193 patients, and thoracoabdominal aorta in 35 patients. RESULTS: Thirty-day mortality occurred in 20 patients (4.8%). Neurologic events included stroke (5.0%) and spinal cord ischemia (permanent 1.7%, temporary 7.9%). Although dialysis was only required in 1.4% of the patients, 19% had renal failure by RIFLE (Risk, Injury, Failure) criteria. Endoleak occurred in 32.9% of the patients. Ten-year freedom from dissection, rupture, or need for reintervention in treated or adjacent aortic segments (ie, treatment failure) was 63.2%. Independent predictors included presentation with rupture, preexisting renal failure, or intervention on the arch aorta (all Ps < 0.03). Aortic pathology also independently predicted treatment failure (P = 0.026). The 15-year survival rate was 32.3%. Advancing age, presence of coronary artery disease, rupture, or postoperative renal failure (all Ps < 0.05), but not treatment failure (P = 0.926), independently predicted late mortality. CONCLUSIONS: Thoracic endovascular aortic repair can be performed with acceptable results in a high-risk population. The risk of treatment failure persists, underscoring the importance of continued long-term endograft surveillance, but this does not seem to impact late mortality.

Open and endovascular repair of the nontraumatic isolated aortic arch aneurysm.

OBJECTIVE: Repair of isolated aortic arch aneurysms (nontraumatic) by either open (OAR) or endovascular (TEVAR) methods is associated with need for hypothermic circulatory arrest, complex debranching procedures, or use of marginal proximal landing zones. This study evaluates outcomes for treatment of this cohort. METHODS: Of 2153 patients undergoing arch repair (1993-2013), 137 (mean age, 60 years) were treated with isolated arch resection for nontraumatic aneurysms. Treatment was by open (n = 93), hybrid (n = 11), or TEVAR (n = 33) methods, with the last two approaches reserved for poor OAR candidates. Treatment was predominantly for saccular (n = 53) or fusiform (n = 30) aneurysms or dissection (n = 15). Rupture was present in 15%. Prior aortic repair was performed in the ascending (n = 30), arch (n = 40), descending (n = 24), or abdominal (n = 9) aorta. Propensity score adjustment was performed for multivariable analysis to account for baseline differences in patient groups as well as treatment selection bias. RESULTS: Early mortality was seen in nine patients (7%). Morbidity included stroke (n = 9), paraplegia (n = 1), and need for dialysis (n = 5) or tracheostomy (n = 10). A composite outcome of death and stroke was independently predicted by advancing age (P = .055) and performance of a hybrid procedure (P = .012). The 15-year survival was 59%, with late mortality predicted by increasing age, presence of peripheral vascular disease, and perioperative stroke (all P < .05). The 10-year freedom from aortic rupture or reintervention was 75% and was higher after OAR (2-year OAR, 94% vs TEVAR or hybrid, 78%; P = .018). After propensity-adjusted Cox regression analysis, both prior abdominal aortic aneurysmectomy (P = .017) and an endovascular or hybrid procedure (P = .001) independently predicted late aortic rupture or need for reintervention. CONCLUSIONS: Isolated arch repair remains a high-risk procedure occurring frequently in the reoperative setting. Despite being performed in a higher risk group, endovascular strategies yielded similar outcomes but with an increased risk for aorta-related complications. These data support ongoing efforts to develop branched endografts specifically tailored for arch disease to potentially reduce morbidity related to currently available approaches.

Alternative access techniques with thoracic endovascular aortic repair, open iliac conduit versus endoconduit technique.

BACKGROUND: Iliac artery endoconduits (ECs) have emerged as important alternatives to retroperitoneal open iliac conduits (ROICs) to aid in transfemoral delivery for thoracic endovascular aortic repair (TEVAR). We present, to our knowledge, the first comparative analysis between these alternative approaches. METHODS: All patients undergoing TEVAR with either ROIC (n = 23) or internal EC (n = 16) were identified. The mean age of the cohort was 72.4 ± 11.5 years (82.1% female). Device delivery was accomplished in 100% of cases. The primary outcome was the presence of iliofemoral complications, which was defined as: (1) the inability to successfully deliver the device into the aorta via the ROIC or EC approach; (2) rupture, dissection, or thrombosis of the ipsilateral iliac or femoral artery; and/or (3) retroperitoneal hematoma requiring exploration and evacuation. Secondary outcomes were 30-day mortality and rates of limb loss, claudication, or revascularization. RESULTS: At a median follow-up of 10.1 months, the incidence of iliofemoral complications was less for the EC approach compared with the ROIC technique (12.5% vs 26.1%; P = .301). No patients sustained limb loss. Revascularization was performed in two patients after ROIC. Lower extremity claudication occurred in one patient after EC. Early mortality was seen in one patient who underwent EC. Two-year Kaplan-Meier survival for the entire cohort was 74.4%, and did not differ between groups (ROIC, 78.3% vs EC, 68.8%; P = .350). Two-year Kaplan-Meier freedom from limb loss, claudication, or revascularization did not differ between the two approaches (ROIC, 91.3% vs EC, 93.8%; P = .961). CONCLUSIONS: Results of this early comparative evaluation of alternative access routes for TEVAR suggest that an EC approach is safe, effective, and associated with low rates of early mortality and late iliofemoral complications. In selected patients, the EC may be considered an appropriate delivery route for transfemoral TEVAR.

The perfect prosthesis/patient match: pursuit of the Holy Grail.

In 1978, Rahimtoola published a successful series of surgical aortic valve replacements (SAVR) on patients with severe aortic stenosis (AS) with congestive heart failure (CHF). He described the perfect prosthesis-patient match as a "prosthetic valve with a functioning opening area that matches the patient's normal functioning valve." This manuscript revisits the forty-six-year journey in pursuit of that perfect match. We address the essential components for the perfect match, such as the usefulness of the current valve sizing techniques using the manufacturer's labeled valve size (MLVS) and sizer, the accuracy of an objective parameter to define the perfect match, and the need and safety to enlarge the patient's annulus and root to accommodate the proper size valve. A thorough literature search was performed using the University of Michigan Medical Library search engine. The population included patients who underwent SAVR. Three individual searches were conducted: (I) valve size and sizing techniques; (II) hemodynamic performance (HP) and prosthesis-patient mismatch (PPM); and (III) aortic root enlargement (ARE) procedures. Excluded were articles not in English, articles that involved animal research, duplicate articles, articles involving valve repair, allograft or autograft replacement, and articles specific to aortic sizing and congenital heart surgery. The emphasis was placed on randomized prospective trials, large registry trials with and without propensity matching, and meta-analysis articles. We discovered that the manufacturer-labeled valve size and sizing technique does not accurately represent the functional opening area of the valve. A pre-operative multidetector computed tomography (CT) scan is an accurate and reproducible method for measuring patient root and annulus dimensions and should be used for pre-operative valve sizing for SAVR. Matching the CT area derived aortic diameter with the true functional diameter of the opening of the prosthetic valve will yield the best prosthesis-patient match. ARE is safe and should be used to attain the best match.

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.

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 Surgical Replacement and Transcatheter Aortic Valve Implantation (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.

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.

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.

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).

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.

Asymmetric expansion of aortic aneurysms on computed tomography imaging.

OBJECTIVE: To investigate whether wall growth during aneurysm development spares the aortic wall between the intercostal or lumbar arteries or, alternatively, is uniform around the circumference. METHODS: Computed tomography scans of 155 patients with aortic aneurysms (40 thoracic, 50 thoracoabdominal, and 65 abdominal) in a single hospital of a large academic institution were retrospectively inspected. Computed tomography studies of 100 control subjects (40 thoracic and 60 abdominal) were also reviewed. In all 255 patients, the ratio of the arc length between the origins of the intercostal or lumbar arteries (interbranch arc length) to the remainder of the aortic residual circumference was calculated. These ratios were compared between all subjects with aneurysms and the controls at each vertebral body level and between those with thoracic or thoracoabdominal or abdominal aneurysms and controls at each vertebral body level. RESULTS: Interbranch arc lengths and residual aortic circumferences were larger in aneurysm patients than in control subjects, but the differences were statistically significant only at T4 and from T8 to L4 (P = .009 to P < .001) and from T4 to L4 (P < .001), respectively. The ratio of interbranch arc length to residual circumference in aneurysmal aortas was significantly smaller than that in controls at 12 out of 13 levels from T4 to L4 (P = .004 to P < .001). There was a statistically significant smaller ratio at 8 out of 9 levels for thoracic aneurysms (P = .006 to P < .001), 12 out of 13 levels for thoracoabdominal aneurysms (P = .008 to P < .001), and 3 out of 4 levels for abdominal aneurysms compared with controls (P = .006 to P < .001). CONCLUSIONS: Wall growth in aortic aneurysms is asymmetric, with greater aneurysmal growth in the anterior aorta wall and relative sparing of the portion of aortic wall between the intercostal or lumbar arteries. The mechanisms effecting this asymmetric growth have not been fully characterized.