Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis and Small Aortic Annulus: A Randomized Clinical Trial.

BACKGROUND: The optimal treatment in patients with severe aortic stenosis and small aortic annulus (SAA) remains to be determined. This study aimed to compare the hemodynamic and clinical outcomes between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in patients with a SAA. METHODS: This prospective multicenter international randomized trial was performed in 15 university hospitals. Participants were 151 patients with severe aortic stenosis and SAA (mean diameter <23 mm) randomized (1:1) to TAVR (n=77) versus SAVR (n=74). The primary outcome was impaired valve hemodynamics (ie, severe prosthesis patient mismatch or moderate-severe aortic regurgitation) at 60 days as evaluated by Doppler echocardiography and analyzed in a central echocardiography core laboratory. Clinical events were secondary outcomes. RESULTS: The mean age of the participants was 75.5±5.1 years, with 140 (93%) women, a median Society of Thoracic Surgeons predicted risk of mortality of 2.50% (interquartile range, 1.67%-3.28%), and a median annulus diameter of 21.1 mm (interquartile range, 20.4-22.0 mm). There were no differences between groups in the rate of severe prosthesis patient mismatch (TAVR, 4 [5.6%]; SAVR, 7 [10.3%]; P=0.30) and moderate-severe aortic regurgitation (none in both groups). No differences were found between groups in mortality rate (TAVR, 1 [1.3%]; SAVR, 1 [1.4%]; P=1.00) and stroke (TAVR, 0; SAVR, 2 [2.7%]; P=0.24) at 30 days. After a median follow-up of 2 (interquartile range, 1-4) years, there were no differences between groups in mortality rate (TAVR, 7 [9.1%]; SAVR, 6 [8.1%]; P=0.89), stroke (TAVR, 3 [3.9%]; SAVR, 3 [4.1%]; P=0.95), and cardiac hospitalization (TAVR, 15 [19.5%]; SAVR, 15 [20.3%]; P=0.80). CONCLUSIONS: In patients with severe aortic stenosis and SAA (women in the majority), there was no evidence of superiority of contemporary TAVR versus SAVR in valve hemodynamic results. After a median follow-up of 2 years, there were no differences in clinical outcomes between groups. These findings suggest that the 2 therapies represent a valid alternative for treating patients with severe aortic stenosis and SAA, and treatment selection should likely be individualized according to baseline characteristics, additional anatomical risk factors, and patient preference. However, the results of this study should be interpreted with caution because of the limited sample size leading to an underpowered study, and need to be confirmed in future larger studies. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03383445.

Macroscopic and microscopic features of surgically explanted transcatheter aortic valve prostheses.

OBJECTIVES: With the extended indications of transcatheter aortic valve (TAV) replacement (TAVR) to lower-risk patients, there is an increasing number of patients requiring surgical explantation of failed TAV. We sought to describe macroscopic and microscopic features of surgically explanted percutaneous aortic valve prostheses. METHODS: Preoperative and surgical characteristic of patients undergoing surgical explantation of TAV were retrospectively analyzed from 2007 to 2020. Surgical and pathologic features of these valves, and outcomes of the surgical valve replacement were described. RESULTS: Out of 1764 patients who underwent a TAVR procedure, 21 were operated for TAV failure. Isolated or combined indications for surgery included: significant paravalvular leak (n = 15), delayed prosthesis migration (n = 5), significant increase of trans-TAV gradients (n = 6), and endocarditis (n = 3). Mean time elapsed between TAVR and explantations was 674.9 ± 803.9 days. Macroscopic lesions found on explanted percutaneous valves were severe adhesions to the aorta (n = 10), calcifications (n = 7), leaflet thrombosis (n = 4), and vegetations (n = 3). Except for patients with endocarditis, one or more pathological lesions were found in 15 patients. Pathology analyses on these valves showed fibro-calcific degenerations (n = 12), pannus formation (n = 9), and chronic inflammation (n = 3). One patient (4.8%) died after surgical explantation, and 13 (61.9%) had concomitant procedures. The survival rate at 1 year was 94.4%. CONCLUSIONS: Microscopic findings of fibro-calcific leaflet degeneration, and pannus formation in addition to macroscopic calcification and thrombosis present early, (within a mean of 2 years) after TAVR. Further investigation with a higher number of patients and echocardiographic follow-up is warranted.

Post-pneumonectomy patients undergoing cardiac surgery: A case series.

BACKGROUND: Data regarding post-pneumonectomy patient assessment for cardiac surgery is scarce. This retrospective study was conducted to define early and late outcomes in these patients, and to identify risk factors for poor outcomes. METHODS: This study included patients with a previous history of pneumonectomy undergoing on-pump cardiac surgery with median sternotomy. The institutional database was reviewed from 1992 to 2018. RESULTS: Sixteen post-pneumonectomy patients (all lung cancer) were identified. The age range was 53-81 years. The mean FEV1/FVC was 69%. The mean EuroSCORE II was 11.6%. Four patients had heart failure symptoms in the 2 weeks before surgery. Seven patients had isolated coronary artery bypass grafting (CABG) and six patients had CABG + aortic valve replacement (AVR). The major perioperative events affecting the ease and outcomes of the surgical procedures were structural shifts (5), extensive adhesions on heart and vessels (5), and extensive calcification of heart components (5). Important postoperative complications were respiratory (7), infections (5), and acute kidney injury (5). The median hospital length of stay was 7 days. Five patients died in hospital (none with isolated CABG) with a preoperative New York Heart Association classification (NYHA) of III-IV, a cardiopulmonary bypass time of 175.2 min and an aortic cross-clamp time of 104.0 min. The long-term survival data were recorded with a mean follow-up of 7.3 ± 7.1 years (range from 0 to 19). The overall, 5-year survival, was 50% for all cardiac surgeries, 71% for isolated CABG surgeries, and 17% for CABG + AVR surgeries, respectively. CONCLUSION: Post-pneumonectomy patients have acceptable postoperative outcomes and survival. Simple and short surgeries with careful planning can yield favorable outcomes for this high-risk subgroup of patients.

Prognosis of functional mitral regurgitation after aortic valve replacement for pure severe aortic stenosis.

OBJECTIVE: Whether patients with severe aortic stenosis (AS) and significant functional mitral regurgitation (MR) should undergo isolated aortic (aortic valve replacement [AVR]) or double aortic-mitral valve procedure (DVP) remains controversial. We sought to determine outcomes of such patients undergoing surgical (surgical aortic valve replacement [SAVR]) and transcatheter AVR (TAVR) or DVP, identify echocardiographic parameters predictive of significant residual MR after isolated AVR, and determine its impact on long-term survival. METHODS: Data prospectively collected from 736 consecutive patients with severe AS and significant MR undergoing AVR or DVP were retrospectively analyzed. Exclusion of organic MR, other valve diseases and concomitant CABG yielded a final population of 74 patients with significant functional MR (32 TAVR, 23 SAVR, 19 DVP). Demographics, postoperative complications and age-adjusted survival were compared. Echocardiographic predictors of significant residual MR and its impact on survival were analyzed for patients undergoing isolated AVR. RESULTS: In the isolated AVR group, MR improvement occurred in 60% of patients and was associated with a significant increase in survival compared to persistence of significant MR (p = .03). Patients with improved MR had significantly greater preoperative left ventricular dilatation (LVEDD: 49 vs. 43 mm, p = .001; LVESD: 35 vs. 29 mm, p = .03; LVEDV: 101 vs. 71 ml, p = .0003; LVESV: 57 vs. 33 ml, p = .002). There was no significant difference in perioperative mortality (5.3 vs. 4.4 vs. 9.4%, p = .85) or age-adjusted long-term survival between isolated AVR and DVP groups (76.3 vs. 84.2% survival at 2-year follow-up, p = .26), or between SAVR, TAVR and DVP groups (78.2 vs. 75.0 vs. 84.2% survival at 2-year follow-up, p = .13). CONCLUSIONS: After isolated AVR, MR improvement occurs in 60% of patients. It is predicted by greater ventricular dimensions and associated with significantly better long-term survival. Whether a staged approach with transcatheter correction of MR should be considered in patients with significant residual MR following AVR remains undetermined.

Early to midterm survival of patients with deep sternal wound infection managed with laparoscopically harvested omentum.

OBJECTIVE: The optimal management of deep sternal wound infection (DWSI) remains controversial. Our objective was to evaluate outcomes of patients with DSWI managed with transposition of laparoscopically harvested omentum (LHO). METHODS: Between 2000 and 2020, a total of 38,623 adult patients who underwent full median sternotomy for cardiac surgery were analyzed retrospectively at our institution. DSWI occurred in 455 (1.2%), of whom 364 (93.2%) were managed with pectoralis myocutaneous flap (PMF) and 33 (7.2%) with LHO. Univariate and multivariate analysis models were used to determine predictors of cumulative late mortality and adjusted survival curves were generated. RESULTS: Among patients who received LHO, average age was 65.7 ± 9.7 years and a larger proportion of patients were male. A majority of patients (88%) had coronary bypass surgery, with bilateral internal mammary arteries use in only 21.2%. Mean length of stay (LOS) was 58.90 days and early hospital mortality occurred in 4 patients (12.1%). Patients who received LHO compared to only PMF had larger body mass index and had more heart failure. Furthermore, the hospital LOS was also significantly prolonged in the LHO group (58.9 vs. 27.4 days, p = .002), with a slightly higher in-hospital mortality (12.1% vs. 3.3%, p = .03). Late survival for LHO patients at 5 and 10 years was 71.9% and 44.8%, respectively. CONCLUSION: Use of LHO is a safe and viable alternative to traditional myocutaneous flaps to manage complex DSWI. Early and late survival were favorable in this high-risk population.

Aortic Stenosis and Small Aortic Annulus.

The presence of a small aortic annulus poses a considerable challenge in the management of patients with severe aortic stenosis, especially in elderly women, where it is a very frequent finding. The optimal approach for treating these patients remains controversial, and several surgical strategies such as aortic root enlargement, supra-annular stented prosthetic valves, stentless bioprosthesis, and sutureless bioprostheses have been proposed to improve valve hemodynamics and clinical outcomes. More recently, transcatheter aortic valve replacement has emerged as a valid alternative for the treatment of aortic stenosis and excellent valve hemodynamic results have been observed among patients with a small aortic annulus. The purpose of this review is to provide an overview of the current definition, prevalence, and clinical impact of small aortic annulus in patients with aortic stenosis, and evaluate the different therapeutic strategies currently available to improve valve hemodynamics and outcomes in this population.

Intraprocedural high-degree atrioventricular block or complete heart block in transcatheter aortic valve replacement recipients with no prior intraventricular conduction disturbances.

BACKGROUND: Conduction disturbances are the most frequent complication of transcatheter aortic valve replacement (TAVR). However, no data exists regarding the outcomes of intraprocedural high-degree atrioventricular block (HAVB) or complete heart block (CHB) in patients without previous conduction disturbances. OBJECTIVES: The aim of this study was to evaluate the outcomes of intraprocedural-HAVB/CHB in patients without previous intraventricular conduction disturbances. METHODS: The occurrence of intraprocedural-HAVB/CHB was assessed in 676 consecutive patients undergoing TAVR, and two groups were established according to its duration: persistent-HAVB/CHB (PHAVB/CHB) and transient-HAVB/CHB (THAVB/CHB), not present at the end of the procedure. RESULTS: Intraprocedural-HAVB/CHB occurred in 50 patients (7.4%), being persistent in 32 (64.0%), and transient in 18 (36.0%). The use of Medtronic Corevalve Revalving System (MCRS) and a greater oversizing of the valve increased the risk of intraprocedural-HAVB/CHB (p < 0.001). Permanent pacemaker implantation (PPI) was more frequent in the PHAVB/CHB than in the THAVB/CHB group (96.9% vs. 33.3%; p < 0.001). At 1-month follow-up, the PHAVB/CHB group showed a 98% ventricular pacing rate (VPR) compared to 16% in the THAVB/CHB group (p < 0.001), and similar VPR were observed at 1-year follow-up (98% vs. 37%, p < 0.001). Left ventricular ejection fraction (LVEF) decreased at 1-year follow-up in patients with PHAVB/CHB (-3.9 ± 1.8%, p = 0.003). CONCLUSIONS: In TAVR recipients with no prior intraventricular conduction disturbances, intraprocedural-HAVB/CHB occurred in 7.4% of cases. HAVB/CHB was persistent in most cases and determined a high rate of PPI post-TAVR. Very high VPR at 1- and 12-month follow-up were observed, which in turn was associated with a negative effect on LVEF. These results support early PPI and close follow-up in patients developing intraprocedural-PHAVB/CHB.

Timing and evolution of advanced conduction disturbances in patients with right bundle branch block undergoing transcatheter aortic valve replacement.

AIMS: This study sought to determine the timing and evolution over time of advanced conduction disturbances (CDs) in patients with baseline right bundle branch block (RBBB) undergoing transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: One hundred and ten consecutive patients with pre-existing RBBB were included (out of 1341, 8.2%). All arrhythmias during the hospitalization period were recorded. Follow-up was performed at 30 days, 1 year, and yearly thereafter. Conduction recovery and ventricular pacing percentage (VPP) was evaluated at 30 days in those patients with permanent pacemaker implantation (PPMI). Sixty-one (55.5%) patients suffered advanced CDs [97% complete or high-degree atrioventricular block (CHB/HAVB)], and the vast majority (98%) occurred within the first 3 days post-procedure (intraprocedural: 85%). Fifty-two (47.3%) patients had PPMI (vs. 11.0% in non-RBBB patients, P < 0.001). Ventricular pacing percentage at 1 month was higher in patients with persistent-intraprocedural CHB/HAVB compared to those with transient-intraprocedural or post-procedural CHB/HAVB [99 (interquartile range, IQR 97-100)% vs. 72 (IQR 30-99)%, P = 0.02]. Complete recovery (VPP < 1%) was observed in only one patient (2%) with CHB/HAVB. After hospital discharge, no symptomatic bradyarrhythmias or sudden death occurred within 30 days. Patients with pre-existing RBBB exhibited a higher risk of PPMI at 4-year follow-up (26% vs. 8% in non-RBBB patients, P < 0.001). CONCLUSION: In patients with pre-existing RBBB, the vast majority of advanced CDs occurred within the 3 days following TAVR, and most did not recover at 1-month, particularly those with intra-procedural persistent CHB/HAVB. These results should help to determine the hospitalization length and timing of PPMI in RBBB patients undergoing TAVR.

Annulus root enlargement during redo aortic valve replacement: Perioperative results and hemodynamic impact.

OBJECTIVES: Redo aortic valve replacement (AVR) might present an increased risk for predicted patient-prosthesis mismatch (PPM). Aortic root enlargement (ARE) procedures can decrease PPM and improve hemodynamic parameters. It is crucial to evaluate the safety of ARE in the context of redo AVR to allow better patient selection. METHODS: This is a matched case-control study of 125 patients who underwent a redo AVR between 1991 and 2016, 21 patients had a concomitant ARE procedure. Patients were matched for age, gender, presence of coronary artery disease, renal clearance, left ventricular ejection fraction, and body mass index. The primary outcome was the occurrence of major adverse cardiovascular events (MACE). Secondary outcomes were postoperative impact of the ARE procedures on echocardiographic measurements and survival. RESULTS: Preoperatively, indexed aortic valve area (0.49 vs 0.66 cm2 /m2 ; P = .02) and left ventricle outflow tract diameters (20.1 vs 22.2 mm; P < .01) were significantly smaller in the ARE group. ARE procedures increased the aortic valve area by an average of 0.4 cm2 (pre = 0.9, post = 1.3; P < .01), with a reduction of maximum and mean transvalvular gradients of 26.6 mm Hg (pre = 56.8, post = 30.2; P < .01) and 17.1 mm Hg (pre = 31.9, post = 14.8; P < .01), respectively. Postoperatively, the occurrence of MACE was similar (ARE = 19%, no ARE = 14%; P = .68). Survival rates were similar (P = .29). CONCLUSIONS: For patients undergoing redo AVR, ARE is not associated with higher perioperative mortality and morbidity when compared with patients undergoing AVR without ARE. The fear of perioperative complications potentially associated with ARE should not be a prohibiting factor in symptomatic redo patients with small aortic annulus and predicted PPM.

Rate, Timing, Correlates, and Outcomes of Hemodynamic Valve Deterioration After Bioprosthetic Surgical Aortic Valve Replacement.

BACKGROUND: The incidence of structural valve deterioration after bioprosthesis (BP) aortic valve replacement (AVR) established on the basis of reoperation may substantially underestimate the true incidence. The objective is to determine the rate, timing, correlates, and association between hemodynamic valve deterioration (HVD) and outcomes assessed by Doppler echocardiography after surgical BP AVR. METHODS: A total of 1387 patients (62.2% male, 70.5±7.8 years of age) who underwent BP AVR were included in this retrospective study. Baseline echocardiography was performed at a median time of 4.1 (1.3-6.5) months after AVR. All patients had an echocardiographic follow-up ≥2 years after AVR (926 at least 5 years and 385 at least 10 years). HVD was defined by Doppler assessment as a ≥10 mm Hg increase in mean gradient or worsening of transprosthetic regurgitation ≥1/3 class. HVD was classified according to the timing after AVR: "very early," during the first 2-years; "early," between 2 and 5 years; "midterm," between 5 and 10 years; and "long-term," >10 years. RESULTS: A total of 428 patients (30.9%) developed HVD. Among these patients, 52 (12.0%) were classified as "very early," 129 (30.1%) as "early," 158 (36.9%) as "midterm," and 89 (20.8%) as "long-term" HVD. Factors independently associated with HVD occurring within the first 5 years after AVR were diabetes mellitus ( P=0.01), active smoking ( P=0.01), renal insufficiency ( P=0.01), baseline postoperative mean gradient ≥15 mm Hg ( P=0.04) or transprosthetic regurgitation ≥mild ( P=0.04), and type of BP (stented versus stentless, P=0.003). Factors associated with HVD occurring after the fifth year after AVR were female sex ( P=0.03), warfarin use ( P=0.007), and BP type ( P<0.001). HVD was independently associated with mortality (hazard ratio, 2.18; 95% CI, 1.86-2.57; P<0.001). CONCLUSIONS: HVD as identified by Doppler echocardiography occurred in one third of patients and was associated with a 2.2-fold higher adjusted mortality. Diabetes mellitus and renal insufficiency were associated with early HVD, whereas female sex, warfarin use, and stented BPs (versus stentless) were associated with late HVD.

Sex-Related Discordance Between Aortic Valve Calcification and Hemodynamic Severity of Aortic Stenosis: Is Valvular Fibrosis the Explanation?

RATIONALE: Calcific aortic stenosis (AS) is characterized by calcium deposition in valve leaflets. However, women present lower aortic valve calcification loads than men for the same AS hemodynamic severity. OBJECTIVE: We, thus, aimed to assess sex differences in aortic valve fibrocalcific remodeling. METHODS AND RESULTS: One hundred and twenty-five patients underwent Doppler echocardiography and multidetector computed tomography within 3 months before aortic valve replacement. Explanted stenotic tricuspid aortic valves were weighed, and fibrosis degree was determined. Sixty-four men and 39 women were frequency matched for age, body mass index, hypertension, renal disease, diabetes mellitus, and AS severity. Mean age (75±9 years), mean gradient (41±18 mm Hg), and indexed aortic valve area (0.41±0.12 cm2/m2) were similar between men and women (all P≥0.18). Median aortic valve calcification (1973 [1124-3490] Agatston units) and mean valve weight (2.36±0.99 g) were lower in women compared with men (both P<0.0001). Aortic valve calcification density correlated better with valve weight in men (r2=0.57; P<0.0001) than in women (r2=0.26; P=0.0008). After adjustment for age, body mass index, aortic valve calcification density, and aortic annulus diameter, female sex was an independent risk factor for higher fibrosis score in AS valves (P=0.003). Picrosirius red staining of explanted valves showed greater amount of collagen fibers (P=0.01), and Masson trichrome staining revealed a greater proportion of dense connective tissue (P=0.02) in women compared with men. CONCLUSIONS: In this series of patients with tricuspid aortic valve and similar AS severity, women have less valvular calcification but more fibrosis compared with men. These findings suggest that the pathophysiology of AS and thus potential targets for drug development may be different according to sex.

Clinical and Technical Characteristics of Coronary Angiography and Percutaneous Coronary Interventions Performed before and after Transcatheter Aortic Valve Replacement with a Balloon-Expandable Valve.

OBJECTIVES: To report on the feasibility and technical differences between coronary procedures performed before and after TAVR with the balloon-expandable Edwards-SAPIEN or the SAPIEN XT valves. BACKGROUND: Coronary artery disease (CAD) and aortic stenosis often coexist. Transcatheter aortic valve replacement (TAVR) is emerging as a treatment for younger and lower surgical risk patients who might not present with clinically evident CAD before TAVR. The demand for performing post-TAVR coronary angiograms (CAs) and percutaneous coronary interventions (PCIs) will thus increase, posing new technical challenges. METHODS: Over 1000 TAVRs were performed at the Quebec Heart and Lung Institute, of which 616 with the abovementioned valves. Of these, 28 patients had an analyzable pre- and post-TAVR CAs and 13 patients had pre- and post-TAVR PCIs performed. Procedural characteristics were gathered from all coronary procedures and subsequently compared amongst the same type of procedure performed at these two distinct time periods. RESULTS: Neither CAs-nor PCIs-performed after valve implantation revealed significant differences regarding arterial access site, catheter diameter, number of diagnostic or guiding catheters used, procedural duration, fluoroscopy time, or achievement of selective coronary injection. Lesion location and classification, as well as the preference of using a drug-eluting stent, remained unchanged. During post-TAVR CA, the amount of contrast delivered and the radiation dose area product were significantly lower compared with pre-TAVR CA values. CONCLUSIONS: Performance of CA and PCI after TAVR with a balloon-expandable valve appears unaffected by its presence.

Significant mitral regurgitation in patients undergoing TAVR: Mechanisms and imaging variables associated with improvement.

BACKGROUND: Significant mitral regurgitation (MR) is associated with poorer outcomes in patients undergoing transcatheter aortic valve replacement (TAVR). Factors associated with MR improvement have not been studied thoroughly. METHODS: Retrospective analysis of consecutive patients treated with TAVR with more than mild MR at baseline. MR evolution was assessed at 1-3 and 6-12 months after intervention. MR severity and mechanisms were assessed by echocardiography. Mitral annulus calcification (MAC) was quantified using preoperative cardiac CT. RESULTS: From 674 consecutive TAVR recipients, 78 with more than mild MR had a 6-12 months follow-up. Following TAVR, MR improved in 34 patients (43%), remained stable in 38 (49%) and worsened in 6 (8%). Patients with MR improvement had greater tenting area (141 ± 56 vs. 99 ± 40 mm2 , P < 0.01), tenting height (7.2 ± 1.9 vs. 5.6 ± 1.9 mm, P < 0.01) and lower ejection fraction (43 ± 16 vs. 52 ± 14%, P = 0.01). MAC was frequent (87.7% of patients) and a trend in greater MAC was observed in patients without MR improvement (3560 ± 5587 vs. 2053 ± 2800, P = 0.16). In multivariable analysis, tenting area (OR per 10 mm2 increase: 1.012, 95% CI, 1.001-1.024 P = 0.039) and annulus calcifications associated with leaflet restriction (OR = 0.108, 95% CI, 0.012-0.956, P = 0.045) were independently associated with MR outcome after TAVR. CONCLUSION: Larger mitral valve tenting area was associated with more improvement of MR after TAVR whereas extensive MAC associated with leaflet restriction was associated with less improvement. This may help in the clinical decision-making process of TAVR candidates with concomitant MR.

Predictors and Association With Clinical Outcomes of the Changes in Exercise Capacity After Transcatheter Aortic Valve Replacement.

BACKGROUND: At present, there are no objective data specifically examining the clinical impact of variations in exercise capacity post-transcatheter aortic valve replacement (TAVR). We describe the changes in exercise capacity between baseline and 6 months post-TAVR, and ascertain factors associated with and clinical implications of a lack of improvement in exercise capacity post-TAVR. METHODS: A total of 305 patients (mean age, 79±9 years; 44% men; Society of Thoracic Surgeons predicted risk mortality score, 6.7±4.2%) undergoing TAVR completed both baseline and follow-up exercise capacity assessments at 6 months post-TAVR. Exercise capacity was evaluated by the 6-minute walk test (6MWT). Clinical outcomes were compared between patients displaying greater than (n=152; improving group) versus less than (n=153; nonimproving group) the median percentage change in distance walked between baseline and 6-month follow-up examinations. The primary outcome measure was clinical event rates, measured from the 6-month post-TAVR period onward. Further dichotomization according to baseline 6MWT distance (less than versus more than median walking distance, or slow walker versus fast walker) was also assessed. RESULTS: The mean overall distances walked pre- and post-TAVR (6 months post-TAVR) were 204±119 and 263±116 m, respectively (Δ6MWT=60±106 m), with 219 (72%) patients demonstrating an increase in their walking distance (median percentage increase of the entire population was 20% [interquartile range, 0%-80%]). Factors independently correlated with reduced exercise capacity improvement included a range of baseline clinical characteristics (older age, female sex, chronic obstructive pulmonary disease; P<0.05 for all), periprocedural major or life-threatening bleeding (P=0.009) and new-onset anemia at 6 months post-TAVR (P=0.009). Failure to improve the 6MWT distance by at least 20% was independently associated with all-cause mortality (P=0.002) and cardiovascular death or rehospitalization for cardiovascular causes (P=0.001). Baseline slow walkers who were able to improve the 6MWT distance presented with significantly better outcomes than nonimprovers (P=0.01 for all-cause mortality; P=0.001 for cardiovascular end point). CONCLUSIONS: Approximately one-third of patients undergoing TAVR did not improve their exercise capacity postprocedure. The lack of functional improvement post-TAVR was predicted by a mix of baseline and periprocedural factors translating into poorer clinical outcomes. These results suggest that systematically implementing exercise capacity assessment pre- and post-TAVR may help to improve patient risk stratification.

Clinical Presentation and Value of Echocardiography in the Diagnosis of Freestyle Aortic Bioprosthesis Leaflet Tears: A Retrospective Study.

BACKGROUND: The unique design of the Freestyle stentless aortic bioprosthesis has led to different mechanisms of failure, particularly leaflet tearing. The aim of this retrospective study was to review the clinical presentation and echocardiographic data of symptomatic patients with leaflet tears and significant aortic regurgitation (AR) following implantation of the Freestyle bioprosthesis. METHODS: Between January 1993 and May 2011, a total of 430 consecutive patients was identified at the authors' institution who had undergone primary aortic valve replacement with a Freestyle stentless aortic bioprosthesis. Clinical and echocardiographic data were collected prospectively for all patients. Structural valve deterioration was the major cause of bioprosthetic valve failure. RESULTS: Twenty symptomatic patients presented with significant AR due to leaflet tears in the absence of more than mild valvular calcification. At presentation, all patients complained of dyspnea. Some 50% of patients (n = 10) presented with acute pulmonary edema, and 10% (n = 2) with cardiogenic shock. A leaflet tear was initially diagnosed using transthoracic echocardiography in five cases (25%), using transesophageal echocardiography (TEE) in eight cases (40%), or at surgery in seven cases (35%). An appropriate diagnosis of leaflet tearing was recognized at surgery in more than one-third of patients. Consequently, clinicians must be aware of the variety of clinical presentations and should have a high degree of suspicion regarding leaflet tears in patients who have received a Freestyle stentless aortic bioprosthesis and present with moderate to severe AR. CONCLUSIONS: For the optimal management of patients with Freestyle stentless aortic bioprosthesis and new moderate to severe AR, TEE should be considered in all patients.

Embolic protection in patients undergoing transaortic transcatheter aortic valve replacement: initial experience with the TriGuard HDH embolic deflection device.

BACKGROUND: Stroke remains one of the most worrisome complications following transcatheter aortic valve replacement (TAVR). This pilot study evaluates the safety, feasibility, and exploratory efficacy of the TriGuard HDH embolic deflection device (Keystone Heart Ltd., Caesarea, Israel) in patients undergoing transaortic TAVR. METHODS: A total of 10 patients (median age: 81 years, STS score: 9.6 ± 5.6%) undergoing transaortic TAVR were included. All 30-day events were recorded and defined according to Valve Academic Research Consortium-2 criteria. Cerebral diffusion-weighted magnetic resonance imaging exams were planned preprocedure and within 10 days post-TAVR. The results of the magnetic resonances were analyzed in an independent core laboratory blinded to clinical data. Neurocognitive evaluation tests (Montreal Cognitive Assessment, Cogstate, Digit Symbol Substitution Test, Word Fluency Test, and Trailmaking tests) were performed at baseline, and within 10 and 30 days post-TAVR. RESULTS: The TriGuard HDH device was successfully deployed in all patients without complications. There was one procedural major vascular complication unrelated to the study device, and no clinically apparent stroke events were observed at 30-day follow-up. Cerebral diffusion weighted magnetic resonance imaging exams were performed in six patients at 7.5 ± 1.9 days post-TAVR showing the presence of new ischemic lesions in five patients (83.3%), which were single lesions in 60% of these individuals. Paired neurocognitive evaluation tests demonstrated no significant changes in neurocognitive parameters over time. CONCLUSIONS: This study shows the safety and feasibility of using the TriGuard HDH embolic protection device in transaortic TAVR. Further studies are warranted to determine the efficacy of embolic protection in this population.

A novel approach for the green synthesis of iron nanoparticles using marigold extract, black liquor, and nanocellulose: Effect on marigold growth parameters.

This study aimed to investigate a novel method for the green synthesis of iron nanoparticles (FeNPs) using marigold extract (Calendula officinalis L), kraft pulping black liquor, and nanocellulose. Then, the efficacy of FeNPs as a direct nanofertilizer on the growth parameters of marigold was investigated. Characterization techniques including FESEM, EDX, VSM, and FTIR were used to confirm the successful synthesis of FeNPs. The characterization results confirmed the formation and presence of FeNPs in the 20-100 nm range. FeNPs synthesized with nanocellulose notably enhanced marigold growth parameters compared to other materials. However, all nanoparticle variants, including those from marigold extract and black liquor, improved germination, plant height, root length, and plant dry weight compared to the control. Moreover, treatments exhibited higher available iron and total plant iron levels than the control. Thus, employing 10 mg FeNPs (prepared with 5.0 % nanocellulose) appears optimal for enhancing marigold growth and yield.

Aortic Stenosis With Coronary Artery Disease: SAVR or TAVR-When and How?

The growing number of candidates for transcatheter aortic valve replacement (TAVR) has increased the interest in the concomitant presence of coronary artery disease (CAD) and severe aortic stenosis (AS), prompting the need to define the appropriate revascularization strategy for each case. The reported prevalence of concurrent AS and CAD has varied over the years on the basis of the CAD definition and the population evaluated. Revascularization for treating CAD in patients with severe AS involves additional interventions that could impact outcomes. The addition of coronary artery bypass grafting (CABG) to surgical aortic valve replacement (SAVR) has demonstrated favourable effects on long-term prognosis, while the impact of adding percutaneous coronary intervention (PCI) to TAVR may depend on the CAD complexity and the feasibility of achieving complete or reasonably incomplete revascularization. Furthermore, the comparison between SAVR+CABG and TAVR+PCI in low-intermediate surgical risk and low-intermediate complex CAD patients did not reveal differences in all-cause mortality or stroke between the groups. However, there is some evidence showing a lower incidence of major cardiovascular events with the SAVR+CABG strategy for patients with complex CAD. Thus, SAVR+CABG seems to be the best option for patients with low-intermediate surgical risk and complex CAD, and TAVR+PCI for high surgical risk patients seeking complete and/or reasonable incomplete revascularization. After deciding between TAVR+PCI or SAVR+CABG, factors such as timing for PCI, low ejection fraction, coronary reaccess, and valve durability must be considered. Finally, alternative methods for assessing CAD severity are currently under evaluation to ascertain their real value for guiding revascularization in patients with severe AS with CAD.

Optimal oversizing in transcatheter aortic valve replacement with the self-expanding Evolut valve system.

OBJECTIVES: Valve oversizing has been associated with reduced paravalvular leaks (PVL) and valve migration risk. However, no optimal cut-off oversizing value has been defined for the Evolut system (Medtronic). The aim of this study was to assess the relationship between the degree of oversizing and moderate-to-severe PVL and determine the optimal oversizing cut-off value. METHODS: We conducted a multicenter study that included 740 consecutive patients with multidetector computed tomography (CT) data. Valve size was selected according to manufacturer recommendations, with oversizing ranging from 10% to 30%. The primary endpoint was moderate-to-severe PVL. RESULTS: The median age was 84 years (79-87 years), with 58.4% women, and a median EuroSCORE II of 4.1% (2.4-7.3%). Moderate-to-severe PVL was observed in 7.0% of the patients. An inverse relationship was found between oversizing and both PVL (11.3%, 8.6%, 5.4%, and 2.7% for quartiles Q1 to Q4; P = .007) and the need for post-dilation (P = .016). The multivariable analysis showed an association between oversizing and PVL (OR: 0.915 for each 1%-increase, P = .002). The optimal oversizing cut-off value to predict PVL was 20%, and PVL was significantly higher in patients with oversizing less than 20% (10.5% vs.4.2%, P less than .001). There were no differences in major clinical events according to the degree of oversizing, and a higher oversizing did not translate into an increased risk of permanent pacemaker (18.4% vs18.3%, P = .976). CONCLUSIONS: In TAVR with the Evolut valve, a higher oversizing was associated with lower rates of moderate-to-severe PVL and a lower need for post-dilation, with no negative impact on procedural and early clinical outcomes. A 20% oversizing threshold could be suggested to reduce PVLs. Further prospective studies are warranted to validate optimal oversizing for this valve system.