Transcatheter heart valve explant with infective endocarditis-associated prosthesis failure and outcomes: the EXPLANT-TAVR international registry.

BACKGROUND AND AIMS: Surgical explantation of transcatheter heart valves (THVs) is rapidly increasing, but there are limited data on patients with THV-associated infective endocarditis (IE). This study aims to assess the outcomes of patients undergoing THV explant for IE. METHODS: All patients who underwent THV explant between 2011 and 2022 from 44 sites in the EXPLANT-TAVR registry were identified. Patients with IE as the reason for THV explant were compared to those with other mechanisms of bioprosthetic valve dysfunction (BVD). RESULTS: A total of 372 patients from the EXPLANT-TAVR registry were included. Among them, 184 (49.5%) patients underwent THV explant due to IE and 188 (50.5%) patients due to BVD. At the index transcatheter aortic valve replacement, patients undergoing THV explant for IE were older (74.3 ± 8.6 vs. 71 ± 10.6 years) and had a lower Society of Thoracic Surgeons risk score [2.6% (1.8-5.0) vs. 3.3% (2.1-5.6), P = .029] compared to patients with BVD. Compared to BVD, IE patients had longer intensive care unit and hospital stays (P < .05) and higher stroke rates at 30 days (8.6% vs. 2.9%, P = .032) and 1 year (16.2% vs. 5.2%, P = .010). Adjusted in-hospital, 30-day, and 1-year mortality was 12.1%, 16.1%, and 33.8%, respectively, for the entire cohort, with no significant differences between groups. Although mortality was numerically higher in IE patients 3 years postsurgery (29.6% for BVD vs. 43.9% for IE), Kaplan-Meier analysis showed no significant differences between groups (P = .16). CONCLUSIONS: In the EXPLANT-TAVR registry, patients undergoing THV explant for IE had higher 30-day and 1-year stroke rates and longer intensive care unit and hospital stays. Moreover, patients undergoing THV explant for IE had a higher 3-year mortality rate, which did not reach statistical significance given the relatively small sample size of this unique cohort and the reduced number of events.

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.

Treatment strategies and outcomes following acute type A aortic dissection repair in patients with bicuspid and tricuspid aortic valves: A meta-analysis.

Background: There is no consensus regarding the strategies for repairing acute type A aortic dissection (ATAAD) in patients with bicuspid aortic valve (BAV). This meta-analysis aimed to compare the treatment strategies and outcomes of ATAAD repair between patients with BAV and those with tricuspid aortic valve (TAV). Methods: A systematic review of databases were performed from inception through March 2023. The primary outcome of interest was all-cause mortality, with a minimum follow-up of 1 year. The secondary outcomes of interest included ratios of performed procedures and rate of distal aortic reoperation. Data were extracted, and pooled analysis was performed using a random-effects model. Results: Eight observational studies including a total of 3701 patients (BAV, n = 349; TAV, n = 3352) were selected for a meta-analysis. Concerning proximal aortic procedures, BAV patients exhibited a higher incidence of necessary root replacement (odds ratio [OR], 6.53; 95% confidence interval [CI], 3.84 to 11.09; P < .01). Regarding distal aortic procedures, extended arch replacement was performed less frequently in BAV patients (OR, 0.69; 95% CI, 0.49 to 0.99; P = .04), whereas hemiarch procedure rates were comparable in the 2 groups. All-cause mortality was lower in the BAV group (hazard ratio, 0.68; 95% CI, 0.50 to 0.92; P = .01). Distal aortic reoperation rates were comparable in the 2 groups. Conclusions: This study highlights distinct procedural patterns in ATAAD patients with BAV and TAV. Despite differing baseline characteristics, BAV patients exhibited superior survival compared to TAV patients, with comparable distal aortic reoperation rates. These findings may be useful for decision making regarding limited versus extended aortic arch repair.

The Impact of Bicuspid Aortic Valve on Long-term Outcomes After Bioprosthetic Valve Replacement.

BACKGROUND: There are limited data comparing the outcomes of aortic valve replacement surgery between patients with bicuspid aortic valve (BAV) vs tricuspid aortic valve (TAV) morphology. METHODS: From January 2000 to June 2022, 1122 patients with TAV (n = 562) or BAV (n = 560) underwent surgical aortic valve replacement for aortic stenosis with the same type of bovine pericardial stented bioprosthesis. Propensity score matching identified 350 pairs by matching for age, sex, operative status, chronic lung disease, prior stroke, diabetes, ejection fraction, renal failure on dialysis, coronary artery disease, prior cardiac surgery, and concomitant procedures. The primary end points were long-term survival and reoperation. RESULTS: Perioperative outcomes, including reoperation for bleeding, atrial fibrillation, heart block requiring pacemaker, stroke, need for dialysis, and operative mortality, were similar between the matched groups. Survival at 10 years was 67% (95% CI, 59%-74%) in the BAV group and 54% (95% CI, 46%-61%) in the TAV group (P = .001). BAV valve was a significant protective factor for late mortality, with a hazard ratio of 0.60 (95% CI, 0.45-0.81; P < .001). Risk factors for late mortality included age, chronic lung disease, low ejection fraction, and renal failure on dialysis. Cumulative incidence of aortic valve reintervention at 10 years was similar between the groups at 10% in the BAV group and 4.9% in the TAV group (P = .55). CONCLUSIONS: Patients with BAV likely could not be considered the same as patients with TAV when deciding on the approach of aortic valve intervention.

Comparison of the short-term outcomes between Y-incision aortic annular enlargement and traditional aortic annular enlargement techniques.

Background: The short-term efficacy and safety of the Y-incision technique of aortic annular enlargement (AAE) has been established. We aimed to determine how the short-term outcomes of the Y-incision technique compared to traditional AAE techniques. Methods: From February 2011 to June 2022, 380 patients at the University of Michigan Hospital underwent aortic valve replacement (AVR) with AAE using either traditional annular enlargement techniques (Traditional group, n=270), including Nicks [63% (171/270)], Manouguian [34% (91/270)], and others [3% (8/270)], or the Y-incision technique (Y-incision group, n=110). Propensity score matching was performed by controlling for age, sex, body surface area (BSA), hypertension, diabetes, dialysis, chronic lung disease, stroke, prior cardiac surgery, primary indication, operative status, concomitant procedures, and prosthesis type, to generate a balanced cohort of 103 pairs. Results: There were no differences in demographics, comorbidities, primary indications of the operations, or concomitant procedures between the matched groups. The median native aortic annulus diameter, measured in the operating room, was 21 mm for both groups. Median prosthesis size was 23 in the Traditional group, and 27 in the Y-incision group (P<0.001). There were no differences in perioperative complications/outcomes between the matched groups, including operative mortality, which was 3.9% (8/206) overall. Short-term survival was similar between the groups on Kaplan-Meier analysis; one-year survival was 95% in the Traditional group, and 97% in the Y-incision group (P=0.54). The Y-incision group had significantly lower mean aortic valve gradients (7 vs. 10 mmHg, P<0.001), larger aortic valve areas (2.2 vs. 1.8 cm2, P=0.007), and less moderate/severe patient-prosthesis mismatch (PPM) (5.5% vs. 23%, P=0.039) on one-year follow-up echocardiography. Conclusions: The Y-incision technique was as safe and more effective in enlarging the aortic annulus and upsizing the prosthetic valve than the traditional techniques of AAE in AVR for small aortic annuli.

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.

Aortic Annular Enlargement versus Isolated Aortic Valve Replacement in Patients with Matched Annulus.

BACKGROUND: We aimed to determine the effect of aortic annular enlargement on the mid-term outcomes of aortic valve replacement surgery by comparing patients with the same-sized (≤23 mm) native aortic annuli. METHODS: From January 2011 to June 2022, 1,328 patients underwent isolated aortic valve replacement-1,163 without aortic annular enlargement (AVR group) and 165 with aortic annular enlargement (AVR+AAE group). Propensity score matching identified 112 pairs, controlling for native aortic annulus diameter, age, sex, diabetes, chronic lung disease, dialysis, ejection fraction, prior cardiac surgery, indication, hypertension, dyslipidemia, valve type, prior stroke, prior myocardial infarction, and case status. RESULTS: Demographic and preoperative parameters were similar, except body surface area was larger in the AVR+AAE group (2.1 m2 vs 1.9 m2). Median native aortic annulus diameter was 23 mm in both groups. Median prosthesis size was 25 and 23 in the AVR+AAE and AVR groups, respectively. The AVR+AAE group had longer cardiopulmonary bypass (143 vs 111 mins) and cross-clamp (115 vs 82 mins) times. Incidences of perioperative complications including operative mortality (1.8% AVR+AAE vs 3.6% AVR) were similar between groups. 6-year survival was 98% in the AVR+AAE group and 74% in the AVR group (p=0.016). Aortic annular enlargement was an independent protective factor for mid-term mortality with a hazard ratio of 0.19 (p=0.006). The rate of moderate/severe patient-prosthesis mismatch was 19% in the AVR+AAE group and 31% in the AVR group (p=0.16). CONCLUSIONS: Patients with small native aortic annuli (≤23 mm) undergoing isolated aortic valve replacement may benefit from aortic annular enlargement.

Hydrodynamic Assessment of Explanted Degenerated Transcatheter Aortic Valves: Novel Insights Into Noncalcific and Calcific Mechanisms.

BACKGROUND: The etiology of transcatheter aortic valve (TAV) degeneration is poorly understood, particularly noncalcific mechanisms. OBJECTIVES: The authors sought to investigate noncalcific and calcific mechanisms of TAV degeneration and evaluate their impact on leaflet function by bench testing, imaging, and histology. METHODS: TAV explants were obtained from the EXPLANT THV registry and clinical institutions. Hydrodynamic assessment was performed using a heart valve pulse duplicator system under physiological conditions. Micro-computed tomography, high-resolution photography, high speed video, and hematoxylin and eosin staining were used to evaluate the morphological appearance, leaflet kinematics, and calcium burden of TAVs. RESULTS: A total of 14 explants were evaluated: 10 self-expanding CoreValve/Evolut TAVs (Medtronic), 3 balloon-expandable SAPIEN 3 TAVs (Edwards Lifesciences), and 1 mechanically expandable Lotus TAV (Boston Scientific). The median patient age at explantation was 73.0 years (Q1-Q3: 64.5-80.0 years), with a time to explantation of 4 years 1 month (1 year 5 months to 4 years 11 months). Six TAV explants were found to have leaflet calcification (162.4 mm3; 58.8-603.0 mm3), and 8 had no calcification detectable by micro-computed tomography and histology. All samples had impaired leaflet kinematics. There was no significant difference in the hydrodynamic mean gradient between calcified (47.2 mm Hg; 26.6-74.1 mm Hg) and noncalcified (27.6 mm Hg; 15.2-36.7 mm Hg; P = 0.28) TAVs. Leaflet calcification had a weak but nonsignificant association with the hydrodynamic mean gradient (r = 0.42; P = 0.14). CONCLUSIONS: TAV function can be severely impacted by noncalcific and calcific mechanisms of tissue degeneration. Importantly, functional stenosis can occur in TAVs in the absence of obvious and significant calcification.

A Novel Hybrid Prosthesis for Open Repair of Acute DeBakey Type I Dissection with Malperfusion: Early Results from the PERSEVERE Trial.

OBJECTIVE: Outcomes after hemiarch repair for acute DeBakey Type I aortic dissection remain unfavorable, with high rates of major adverse events and negative aortic remodeling. The PERSEVERE study evaluates safety and effectiveness of the AMDS Hybrid prosthesis, a novel bare metal stent, in patients presenting with pre-operative malperfusion. METHODS: PERSEVERE is a prospective, single arm, investigational study conducted at 26 sites in the United States. Ninety-three patients underwent acute DeBakey Type I aortic dissection repair with AMDS implantation. The 30-day primary endpoints are composite rate of 4 major adverse events and rate of distal anastomotic new entry tears. The secondary endpoints include aortic remodeling. RESULTS: Clinical malperfusion was documented in 76 patients (82%), with the remaining having only radiographic malperfusion. Median follow-in 93 patients was 5.6 months. Within 30-days, there were 9 deaths (9.7%), 11 patients (11.8%) with new disabling stroke, 18 patients (19.4%) with new onset renal failure requiring ≥ 1 dialysis treatment, and no myocardial infarction. The composite rate of major adverse events (28%) was less than the reference cohort (58%). There were no distal anastomotic new entry tears. Technical success was achieved in 99% of patients. Early remodeling indicated total aortic diameter stability, true lumen expansion, and false lumen reduction in the treated aortic segment. CONCLUSIONS: Early results show significant reduction in major adverse events and distal anastomotic new entry tears, successfully meeting both primary endpoints. The technical success rate was high. AMDS can be used safely in patients with acute DeBakey type I dissection with malperfusion.

Quality of Life After Transcatheter Aortic Valve Replacement in Normal-Flow, Low-Gradient Aortic Stenosis.

Background: Prior studies of aortic valve replacement (AVR) in patients with normal-flow, low-gradient aortic stenosis (NF-LG AS) have demonstrated conflicting results regarding the survival benefit of AVR. Changes in quality of life (QoL) after transcatheter AVR (TAVR) have not been reported in this population. Objectives: The purpose of this study was to compare changes in QoL after TAVR for patients with NF-LG AS to patients with high-gradient aortic stenosis (HG-AS). Methods: Patients who underwent TAVR for severe aortic stenosis (AS) were divided into 4 hemodynamic profiles of AS, including NF-LG AS. Changes in Kansas City Cardiomyopathy Questionnaire-12 score from baseline to 1 year were compared between AS groups. The primary composite outcome indicating clinical improvement consisted of survival to 1 year and improved Kansas City Cardiomyopathy Questionnaire overall summary score of ≥5 points while adjusting for relevant baseline factors. Results: Out of 860 patients who underwent TAVR, high gradient AS was present in 368 (42.8%) patients and NF-LG AS in 245 (28.5%). HG-AS and NF-LG AS groups had a similar proportion of patients who met the primary unadjusted outcome of clinical improvement (70.4% vs 63.9%, respectively; P = 0.189). One-year Kaplan-Meier mortality estimates were higher for NF-LG AS patients than HG-AS patients (12.9% vs 5.8%, P < 0.001). In the primary adjusted analysis, there was no significant difference in the composite outcome between HG and NF-LG AS groups (adjusted OR: 0.72, 95% CI: 0.47-1.11). Conclusions: Selected patients with NF-LG AS experienced similar improvement in QoL after TAVR compared with HG-AS. Further investigation of patients with NF-LG AS will help to inform optimal selection for treatment with TAVR.

Midterm outcomes of open repair versus endovascular descending thoracic aortic aneurysm repair.

Objective: The study objective was to evaluate the midterm outcome of thoracic endovascular aortic repair compared with open repair in patients with descending thoracic aortic aneurysm. Methods: From August 1993 to February 2023, 499 patients with descending thoracic aortic aneurysms underwent open repair (n = 221) or thoracic endovascular aortic repair (n = 278). Of these, 120 matched pairs were identified using propensity score matching based on age, sex, chronic lung disease, stroke, coronary artery disease, diabetes, ejection fraction, dialysis, peripheral vascular disease, prior cardiac surgery, connective tissue disease, and chronic dissection. Primary outcomes were postoperative paralysis, operative mortality, reoperation, and midterm survival. Results: After matching, the preoperative demographics and comorbidities were balanced in both groups. Intraoperatively, open repair had a lower temperature (18 °C vs 36 °C) and more patients required blood products (66% vs 8%), P < .001. Postoperatively, patients undergoing thoracic endovascular aortic repair had fewer strokes (2.5% vs 9.2%; P = .03), less dialysis (0% vs 3.3%; P = .04), and shorter length of stay (5 days vs 12 days, P < .001), but similar lower-extremity paralysis (2.5% vs 2.5%, P = 1.00) compared with open repair. Furthermore, thoracic endovascular aortic repair had higher 7-year incidence of first reoperation (16.1% vs 3.6%, P < .001) but similar operative mortality (0.8% vs 4.2%; P = .10) and 10-year survival outcome (56%; 95% CI, 43-72 vs 58%; 95% CI, 49-68; P = .55) compared with open aortic repair. The hazard ratio was 0.93 (P = .78) for thoracic endovascular aortic repair for midterm mortality and 6.87 (P < .001) for reoperation. Conclusions: Open repair could be the first option for patients with descending thoracic aortic aneurysms who were surgical candidates.