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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.
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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.
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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.
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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.
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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.
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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.
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Válvula Aórtica , Calcinosis , Prótesis Valvulares Cardíacas , Hidrodinámica , Diseño de Prótesis , Falla de Prótesis , Sistema de Registros , Reemplazo de la Válvula Aórtica Transcatéter , Microtomografía por Rayos X , Humanos , Anciano , Válvula Aórtica/fisiopatología , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Válvula Aórtica/patología , Calcinosis/fisiopatología , Calcinosis/diagnóstico por imagen , Calcinosis/patología , Calcinosis/cirugía , Femenino , Anciano de 80 o más Años , Masculino , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Persona de Mediana Edad , Factores de Tiempo , Remoción de Dispositivos , Estenosis de la Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Hemodinámica , Fenómenos Biomecánicos , Ensayo de Materiales , Grabación en VideoRESUMEN
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.
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Endocarditis , Falla de Prótesis , Infecciones Relacionadas con Prótesis , Sistema de Registros , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Masculino , Femenino , Anciano , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Infecciones Relacionadas con Prótesis/epidemiología , Infecciones Relacionadas con Prótesis/mortalidad , Endocarditis/cirugía , Endocarditis/mortalidad , Remoción de Dispositivos , Prótesis Valvulares Cardíacas/efectos adversos , Bioprótesis/efectos adversos , Resultado del Tratamiento , Anciano de 80 o más Años , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiologíaRESUMEN
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.
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Lesión Renal Aguda , Disección Aórtica , Implantación de Prótesis Vascular , Masculino , Femenino , Humanos , Alta del Paciente , Estudios Retrospectivos , Disección Aórtica/cirugía , Diálisis Renal , Factores de Riesgo , Lesión Renal Aguda/etiología , Lesión Renal Aguda/terapia , Resultado del TratamientoRESUMEN
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.
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Hybrid coronary revascularization (HCR) is an alternative option to conventional coronary artery bypass grafting (CABG), but the long-term outcomes of HCR versus CABG remain unclear. We aimed to analyze the long-term outcomes after HCR and CABG for patients with multivessel coronary artery disease using meta-analysis. A systemic literature search of PubMed and EMBASE was performed from inception to March 2023. Studies reporting Kaplan-Meier curves with follow-up ≥1 year were included. The primary outcome was all-cause mortality, and the secondary outcomes were major adverse cardiac and cerebrovascular events (MACCEs) and repeat revascularization. In total, 13 studies (1 randomized controlled trial and 12 propensity-score matched observational studies) were analyzed. The mean follow-up period was 5.1 ± 3.1 years. HCR was associated with similar overall mortality (hazard ratio [HR] 1.09, 95% confidence interval [CI] 0.87 to 1.36), significantly higher incidence of MACCEs (HR 1.49, 95% CI 1.07 to 2.06), and repeat revascularization (HR 2.01, 95% CI 1.53 to 2.64) compared with CABG. In phase-specific analysis, the mortality rate was similar, and the incidence of repeat revascularization was higher in HCR regardless of phases. The incidence of MACCEs was higher in HCR during the mid-term phase (1 to 5 years), but it was similar during the long-term phase (long-term: ≥5 years). In conclusion, despite the higher incidence of MACCEs and repeat revascularization compared with CABG, HCR offered a similar long-term survival. Even longer-term follow-up and randomized controlled trials with a large population are warranted to investigate the role of HCR for multivessel coronary artery disease.
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Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Humanos , Intervención Coronaria Percutánea/efectos adversos , Resultado del Tratamiento , Puente de Arteria Coronaria/efectos adversos , IncidenciaRESUMEN
BACKGROUND: Transcatheter aortic valve replacement (TAVR) is as an alternative treatment to surgical AVR, but the long-term outcomes of TAVR remain unclear. AIMS: This study aimed to analyze long-term outcomes following TAVR using meta-analysis. METHODS: A literature search was performed with MEDLINE, EMBASE, Cochrane Library, Web of Science, and Google Scholar through November 2022; studies reporting clinical outcomes of TAVR with follow-up periods of ≥8 years were included. The outcomes of interest were overall survival and/or freedom from structural valve deterioration (SVD). Surgical risk was assessed with the Society of Thoracic Surgeons (STS) predicted risk of mortality (PROM) score. A subgroup analysis was conducted for intermediate-/high-surgical risk patients only. RESULTS: Eleven studies including 5458 patients were identified and analyzed. The mean age was 82.0 ± 6.5 years, and mean STS PROM score ranged from 2.9 to 10.6%. Survival rate at 5 and 10 years was 47.7% ± 1.4% and 12.1 ± 2.0%. Five studies including 1509 patients were analyzed for SVD. Freedom from SVD at 5 and 8 years was 95.5 ± 0.7% and 85.1 ± 3.1%. Similar results for survival and SVD were noted in the subgroup analysis of intermediate-/high-risk patients. CONCLUSIONS: Following TAVR, approximately 88% of patients died within 10 years, whereas 85% were free from SVD at 8 years. These date suggest that baseline patient demographic have the greatest impact on survival, and SVD does not seem to have a prognostic impact in this population. Further investigations on longer-term outcomes of younger and lower-risk patients are warranted.
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Estenosis de la Válvula Aórtica , Implantación de Prótesis de Válvulas Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Anciano , Anciano de 80 o más Años , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Resultado del Tratamiento , Factores de RiesgoRESUMEN
Background: The optimal aortic valve substitute for non-elderly adults remains controversial. Recently, considerable data on the Ross procedure have accumulated. This study aimed to analyze long-term outcomes following the Ross procedure from the current literature using a meta-analysis of time-to-event outcomes. Methods: A literature search was performed with MEDLINE, EMBASE, Cochrane Library, Web of Science, and Google Scholar through June 2022; studies reporting clinical outcomes of the Ross procedure beyond 20 years were included for analysis. The outcomes of interest were late survival and freedom from surgical or percutaneous reintervention of the autograft or right ventricular outflow tract (RVOT). Results: Six studies, including 4,910 patients (3,601 males), were identified and analyzed. Survival rate at 5, 10, 15, and 20 years was 99.9%±0.1%, 97.6%±0.5%, 94.3%±0.9%, and 87.4%±1.9%. Freedom from autograft reintervention at 5, 10, 15, and 20 years was 97.7%±0.5%, 95.3%±0.7%, 91.4%±1.2%, 84.8%±2.5%. Freedom from RVOT reintervention was 99.0%±0.3%, 99.0%±0.3%, 97.5%±0.7%, 93.3%±1.8%. Freedom from any valve reintervention (either autograft or RVOT) at 5, 10, 15, and 20 years was 95.8%±0.6%, 92.6%±0.9%, 88.5%±1.2%, 80.8%±2.5%. Conclusions: This meta-analysis demonstrated that the Ross procedure was confirmed to provide excellent survival despite the need for reintervention of autograft or RVOT in approximately 20% of patients at 20 years.
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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.
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BACKGROUND: The latest-generation Evolut FX TAVR system (Medtronic) offers several potential design improvements over its predecessors, but early reported experience has been limited. OBJECTIVES: This study sought to report our multicenter, limited market release, first-in-human experience of transcatheter aortic valve replacement (TAVR) with the Evolut FX system and compare it with a single-center PRO+ (Medtronic) experience. METHODS: From June 27 to September 16, 2022, 226 consecutive patients from 9 US centers underwent transfemoral TAVR with the Evolut FX system for native aortic stenosis (89.4%) or prosthetic valve degeneration (10.6%). Commissural alignment was defined as 0° to 30° between native and FX commissures. Patient, anatomical, and procedural characteristics were retrospectively reviewed, and 30-day clinical and echocardiographic outcomes per Valve Academic Research Consortium-3 definitions were reported. RESULTS: Of 226 patients, 34.1% were low risk, 4% had a bicuspid valve, and 11.5% had a horizontal root (≥60°). Direct Inline sheath (Medtronic) was used in 67.6% and Lunderquist stiff wire (Cook Medical) in 35.4% of cases. Optimal hat marker orientation during deployment was achieved in 98.4%, with commissural alignment in 96.5%. At 30 days, 14.3% mild, 0.9% moderate, and no severe paravalvular leak were observed. Compared with the Evolut PRO+ experience from 1 center, FX had a more symmetrical implantation with shallower depth at the left coronary cusp (P < 0.001), fewer device recaptures (26.1% vs 39.5%; P = 0.004), and improved commissural alignment (96.5% vs 80.2%; P < 0.001). CONCLUSIONS: The Evolut FX system demonstrated favorable 30-day outcomes with a significant improvement over PRO+ in achieving commissural alignment, fewer device recaptures, and more symmetrical implantation. These features may benefit younger patients undergoing TAVR with the supra-annular, self-expanding valve, where lifetime management would be important.
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Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Estudios Retrospectivos , Resultado del Tratamiento , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , CatéteresRESUMEN
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.
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OBJECTIVE: Transcatheter aortic valve replacement (TAVR) is an established alternative to surgical aortic valve replacement (SAVR) for severe symptomatic aortic stenosis, although phase-specific survival and cause of death are implicated following these procedures. Herein, we conducted a phase-specific meta-analysis to compare outcomes after TAVR versus SAVR. METHODS: A systematic search of databases was performed from inception through December 2022 to identify randomized controlled trials that compared outcomes of TAVR and SAVR. For each trial, the hazard ratio (HR) with 95% confidence interval (CI) of outcomes of interest was extracted for the following each specific phase: the very short-term (0-1 years after the procedure), short-term (1-2 years), and mid-term (2-5 years). Phase-specific HRs were separately pooled using the random-effects model. RESULTS: Our analysis included 8 randomized controlled trials, which enrolled a total of 8885 patients with a mean age of 79 years. The survival after TAVR compared with SAVR was greater in the very short-term periods (HR, 0.85; 95% CI, 0.74-0.98; P = .02) but similar in the short-term periods. In contrast, lower survival was observed in the TAVR group compared with the SAVR group in the mid-term periods (HR, 1.15; 95% CI, 1.03-1.29; P = .02). Similar temporal trends favoring SAVR in the mid-term were present for cardiovascular mortality and rehospitalization rates. In contrast, the rates of aortic valve reinterventions and permanent pacemaker implantations were initially greater in the TAVR group, although SAVR's superiority eventually disappeared in the mid-term. CONCLUSIONS: Our analysis demonstrated phase-specific outcomes following TAVR and SAVR.
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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.