Early pacemaker insertion after aortic valve replacement with an Edwards Intuity sutureless valve

BackgroundPostoperative conduction disorders are serious adverse events in patients undergoing aortic valve replacement, and may prolong the duration of hospitalization and require pacemaker insertion.AimOur aim was to evaluate the rate of pacemaker insertion after implantation of an Edwards Intuity sutureless aortic valve (Edwards Lifesciences, Irvine, CA, USA) compared with a standard surgical bioprosthesis.MethodsThis retrospective single-centre study included patients who underwent aortic valve replacement with an Intuity sutureless aortic valve or a standard bioprosthetic valve between 4 June 2014 and 27 June 2016. The main outcome criterion was the rate of postoperative pacemaker insertion. Secondary outcome criteria included the rate of new conduction disorders, the rate of atrial arrhythmia or paroxysmal conduction disorders, mortality and duration of hospital stay.ResultsNinety-three patients received an Intuity sutureless aortic valve (median age 76 years, interquartile range 71–80 years), and 176 were implanted with a standard biological aortic valve (median age 73 years, interquartile range 68–79 years; P = 0.007). The rate of postoperative pacemaker insertion, after adjustment, was 22.44% in the Intuity group and 5.66% in the standard aortic valve group (P = 0.030). The main indications for postoperative pacemaker insertion were complete atrioventricular block and left bundle branch block with prolongation of the H-V interval. The rate of new postoperative left bundle branch block conduction disorders was significantly higher in patients implanted with an Intuity valve (odds ratio 5.28, 95% confidence interval 1.59 to 23.05; P = 0.012).ConclusionHigher rates of pacemaker insertion and new conduction disorders were observed in patients implanted with an Intuity sutureless bioprosthesis compared with those who received a standard surgical aortic valve.     

Transcatheter aortic valve implantation using the SAPIEN 3 valve to treat aortic regurgitation: The French multicentre S3AR study

BackgroundTranscatheter aortic valve implantation now has a major role in the treatment of patients with severe aortic stenosis. However, evidence is scarce on its feasibility and safety to treat patients with pure aortic regurgitation.AimsWe sought to evaluate the results of transcatheter aortic valve implantation using the balloon-expandable SAPIEN 3 transcatheter heart valve (Edwards Lifesciences, Irvine, CA, USA) in patients with pure aortic regurgitation on native non-calcified valves.MethodsWe conducted a retrospective and prospective French multicentre observational study. We included all patients with symptomatic severe pure aortic regurgitation on native non-calcified valves, contraindicated to or at high risk for surgical valve replacement, who underwent transcatheter aortic valve implantation using the SAPIEN 3 transcatheter heart valve.ResultsA total of 37 patients (male sex, 73%) with a median age of 81 years (interquartile range 69–85 years) were screened using transthoracic echocardiography and computed tomography and were included at eight French centres. At baseline, 83.8% of patients (n = 31) had dyspnoea New York Heart Association class ≥ III. The device success rate was 94.6% (n = 35). At 30 days, the all-cause mortality rate was 8.1% (n = 3) and valve migration occurred in 10.8% of cases (n = 4). Dyspnoea New York Heart Association class ≤ II was seen in 86.5% of patients (n = 32), and all survivors had aortic regurgitation grade ≤ 1. At 1-year follow-up, all-cause mortality was 16.2% (n = 6), 89.7% (n = 26/29) of survivors were in New York Heart Association class ≤ II and all had aortic regurgitation grade ≤ 2.ConclusionTranscatheter aortic valve implantation using the SAPIEN 3 transcatheter heart valve seems promising to treat selected high-risk patients with pure aortic regurgitation on non-calcified native valves, contraindicated to surgical aortic valve replacement.     

Evaluación multimodal de la degeneración estructural de válvulas percutáneas en el seguimiento a largo plazo

Introduction and objectivesWe assessed the long-term hemodynamic performance of transcatheter heart valve (THV) by paired transthoracic echocardiography (TTE), and the incidence, characteristics and factors associated with THV structural valve degeneration (SVD).MethodsA total of 212 patients who underwent transcatheter aortic valve replacement and had a potential follow-up > 5 years with at least 1 TTE ≥ 1-year postprocedure were included. All patients had a TTE at 1 to 5 years and 36 had another one at 6 to 10 years. SVD was defined as subclinical (increase > 10 mmHg in mean transvalvular gradient +  decrease > 0.3 cm² in valve area and/or new-onset mild or moderate aortic regurgitation) and clinically relevant (increase > 20 mmHg in mean transvalvular gradient + decrease > 0.6 cm² in valve area and/or new-onset moderate-to-severe aortic regurgitation). Fifteen patients had a transesophageal echocardiography at the time of SVD diagnosis, and 85 an opportunistic computed tomography examination at 1 (0.5-2) years.ResultsTransvalvular mean gradient increased and valve area decreased over time (P < .01). At 8 years of follow-up, SVD occurred in 30.2% of patients (clinically relevant: 9.3%). Transesophageal echocardiography revealed thickened and reduced-mobility leaflets in 80% and 73% of SVD cases, respectively. No baseline or procedural factors were associated with SVD. THV underexpansion (3.5%) or eccentricity (8.2%) had no impact on valve hemodynamics/SVD at follow-up.ConclusionsA gradual THV hemodynamic deterioration occurred throughout a 10-year period, leading to SVD in ～30% of patients (clinically relevant in < 10%). Leaflet morphology/mobility were frequently impaired in SVD cases, but THV geometry did not influence valve hemodynamics or SVD.     

Unsupervised clustering of patients with severe aortic stenosis: A myocardial continuum

BackgroundTraditional statistics, based on prediction models with a limited number of prespecified variables, are probably not adequate to provide an appropriate classification of a condition that is as heterogeneous as aortic stenosis (AS).AimsTo investigate a new classification system for severe AS using phenomapping.MethodsConsecutive patients from a referral centre (training cohort) who met the echocardiographic definition of an aortic valve area (AVA) ≤ 1 cm² were included. Clinical, laboratory and imaging continuous variables were entered into an agglomerative hierarchical clustering model to separate patients into phenogroups. Individuals from an external validation cohort were then assigned to these original clusters using the K nearest neighbour (KNN) function and their 5-year survival was compared after adjustment for aortic valve replacement (AVR) as a time-dependent covariable.ResultsIn total, 613 patients were initially recruited, with a mean ± standard deviation AVA of 0.72 ± 0.17 cm². Twenty-six variables were entered into the model to generate a specific heatmap. Penalized model-based clustering identified four phenogroups (A, B, C and D), of which phenogroups B and D tended to include smaller, older women and larger, older men, respectively. The application of supervised algorithms to the validation cohort (n = 1303) yielded the same clusters, showing incremental cardiac remodelling from phenogroup A to phenogroup D. According to this myocardial continuum, there was a stepwise increase in overall mortality (adjusted hazard ratio for phenogroup D vs A 2.18, 95% confidence interval 1.46–3.26; P < 0.001).ConclusionsArtificial intelligence re-emphasizes the significance of cardiac remodelling in the prognosis of patients with severe AS and highlights AS not only as an isolated valvular condition, but also a global disease.     

Impact of left atrial and diastolic ventricular dysfunction on mortality in patients with aortic stenosis

BackgroundDiastolic dysfunction (DD) is common in severe aortic stenosis (AS) and preserved left ventricular ejection fraction (LVEF ≥ 50%).AimTo determine the impact of American Society of Echocardiography/European Association of Cardiovascular Imaging-recommended DD grading and left atrial strain on mortality in a cohort of patients with severe AS and preserved LVEF.MethodsWe studied patients with severe AS (aortic valve area indexed < 0.6 cm²/m² and/or aortic valve area < 1 cm²), LVEF ≥ 50% and no or mild AS-related symptoms. The endpoint was all-cause mortality.ResultsA total of 387 patients (median age 76 years; 53% women) were studied. During a median follow-up of 57 (interquartile range 37; 83) months, 158 patients died. After adjustment for prognostic factors, patients with grade II or III DD had an increased mortality risk versus patients with grade I DD (adjusted hazard ratio (aHR) 1.62, 95% confidence interval (CI) 1.11–2.38; P = 0.013; aHR 4.73, 95% CI 2.49–8.99; P < 0.001; respectively). Adding peak atrial longitudinal strain (PALS) ≤ 14% to a multivariable model including DD grade improved predictive performance, with better global model fit, reclassification and discrimination. Patients with grade III DD or grade II DD + PALS ≤ 14% displayed an increased mortality risk versus patients with grade I DD + PALS > 14% (aHR 4.17, 95% CI 2.46–7.06; P < 0.0001). Those with grade I DD + PALS ≤ 14% or grade II DD + PALS > 14% were at intermediate risk (aHR 1.63, 95% CI 1.07–2.49; P = 0.024).ConclusionsOur results demonstrate the strong relationship between DD and mortality in patients with severe AS and preserved LVEF. Patients with grade III or grade II DD and impaired PALS are at very high risk. These data demonstrate the importance of a comprehensive assessment of diastolic function in patients with severe AS.     

5-Year Follow-Up From the PARTNER 2 Aortic Valve-in-Valve Registry for Degenerated Aortic Surgical Bioprostheses

ObjectivesThe aim of this study was to report the outcomes of valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) at 5 years.BackgroundTAVR for degenerated surgical bioprostheses in patients at high risk for reoperative surgery is an important treatment option that may delay or obviate the need for surgical intervention; however, long-term outcomes of this procedure are unknown.MethodsThe PARTNER (Placement of Aortic Transcatheter Valves) 2 ViV and continued access registries prospectively enrolled patients with failed surgical bioprostheses at high risk for reoperation. Five-year clinical and echocardiographic follow-up data were obtained in 95.9% of patients.ResultsIn 365 (96 registry and 269 continued access) patients, the mean age was 78.9 ± 10.2 years, the mean Society of Thoracic Surgeons predicted risk of surgical mortality score was 9.1 ± 4.7%, and New York Heart Association functional class was III or IV in 90.4%. At 5 years, the Kaplan-Meier rates of all-cause mortality and any stroke were 50.6% and 10.5%, respectively. Using Valve Academic Research Consortium 3 definitions, the incidence of structural valve deterioration, related hemodynamic valve deterioration, or bioprosthetic valve failure at 5 years was 6.6%. Aortic valve re-replacement was performed in 6.3% (n = 14), the majority of which was due to stenosis (n = 6) and combined aortic insufficiency/paravalvular regurgitation (n = 3). The mean gradient, Doppler velocity index, paravalvular regurgitation, and quality of life measured by Kansas City Cardiomyopathy Questionnaire scores in survivors remained stable from 30 days postprocedure through 5 years.ConclusionsAt the 5-year follow-up, TAVR for bioprosthetic aortic valve failure in high surgical risk patients was associated with sustained improvement in clinical and echocardiographic outcomes.     

Resultados intrahospitalarios tras tratamiento percutáneo frente a quirúrgico en pacientes con estenosis aórtica y enfermedad arterial coronaria concomitante

Introduction and objectivesConcomitant coronary artery disease (CAD) is prevalent among aortic stenosis patients; however the optimal therapeutic strategy remains debated. We investigated periprocedural outcomes among patients undergoing transcatheter aortic valve implantation with percutaneous coronary intervention (TAVI/PCI) vs surgical aortic valve replacement with coronary artery bypass grafting (SAVR/CABG) for aortic stenosis with CAD.MethodsUsing discharge data from the Spanish National Health System, we identified 6194 patients (5217 SAVR/CABG and 977 TAVI/PCI) between 2016 and 2019. Propensity score matching was adjusted for baseline characteristics. The primary outcome was in-hospital all-cause mortality. Secondary outcomes were in-hospital complications and 30-day cardiovascular readmission.ResultsMatching resulted in 774 pairs. In-hospital all-cause mortality was more common in the SAVR/CABG group (3.4% vs 9.4%, P < .001) as was periprocedural stroke (0.9% vs 2.2%; P = .004), acute kidney injury (4.3% vs 16.0%, P < .001), blood transfusion (9.6% vs 21.1%, P < .001), and hospital-acquired pneumonia (0.1% vs 1.7%, P = .001). Permanent pacemaker implantation was higher for matched TAVI/PCI (12.0% vs 5.7%, P < .001). Lower volume centers (< 130 procedures/y) had higher in-hospital all-cause mortality for both procedures: TAVI/PCI (3.6% vs 2.9%, P < .001) and SAVR/CABG (8.3 vs 6.8%, P < .001). Thirty-day cardiovascular readmission did not differ between groups.ConclusionsIn this large contemporary nationwide study, percutaneous management of aortic stenosis and CAD with TAVI/PCI had lower in-hospital mortality and morbidity than surgical intervention. Higher volume centers had less in-hospital mortality in both groups. Dedicated national high-volume heart centers warrant further investigation.     

Effectiveness of high implantation of SAPIEN 3 in preventing pacemaker implantation: A propensity score analysis

BackgroundIn transcatheter aortic valve implantation, high implantation on the aortic annulus may prevent conduction pathway injury, leading to a decrease in the rate of permanent pacemaker implantation.AimTo assess the impact of high implantation of SAPIEN 3 on the prevention of permanent pacemaker implantation.MethodsSince August 2020, we have performed high implantation by fluoroscopically positioning the lower part of the lucent line at the virtual basal ring line on a coplanar view before valve implantation. Patients treated before the adoption of this method were defined as the conventional group. We compared the high implantation group with the conventional group using propensity score analysis.ResultsOverall, the high implantation group (n = 95) showed a significantly shorter ventricular strut length than the conventional group (n = 85): median 1.3 (interquartile range 0.2–2.4) mm vs 2.8 (1.8–4.1) mm (P < 0.001). The permanent pacemaker implantation rate was significantly lower in the high implantation group than in the conventional group (2.1% vs 11.8%; P = 0.009). According to 100 propensity score analyses based on multiple imputation and the selection of appropriate covariates, the median P value for the comparison of permanent pacemaker implantation rates after transcatheter aortic valve implantation between the high implantation group and the conventional group ranged between 0.001 and 0.017, indicating a more significant reduction in the permanent pacemaker implantation rate in the high implantation group than in the conventional group. Neither valve dislodgement nor the need for a second valve was observed in either group.ConclusionsThe high implantation of SAPIEN 3 successfully decreases ventricular strut length, reducing the permanent pacemaker implantation rate after transcatheter aortic valve implantation.     

Valve preserving surgery in patients with bicuspid aortic valve

Bicuspid aortic valve can be associated with clinically important aortic regurgitation and dilatation of ascending aorta. Aortic valve repair seems to be optimal therapeutic option how to avoid valve-related and anticoagulation-related complications. We have analyzed midterm outcomes of patients after bicuspid aortic valve repair.MethodsBetween January 2008 and December 2015, 91 patients (mean age 40.9 ± 12.2) with bicuspid aortic valve (type 0 or 1) underwent valve-sparing surgery for aortic valve insufficiency or aortic aneurysm. Urgent procedures and patients of age more than 65 were not included. The cohort of patients was retrospectively divided into two groups. Forty-nine patients underwent aortic valve-sparing procedure with root replacement (group 1). Forty-two patients underwent aortic valve repair without root replacement (group 2). The mean length of follow-up was 57.5 months.ResultsThere was no death in connection with aortic valve repair during follow up. Three patients from group 2 required in-hospital reoperation for early repair failure. Another seven patients (4 from group 1 and 3 from group 2) were reoperated for recurrent aortic insufficiency during follow-up period. Freedom from aortic valve reoperation at 5 years was 90% in group 1 and 87% in group 2. Freedom from recurrent aortic insufficiency (>2°) at 5 years was 85% in group 1 and 78% in group 2.ConclusionBicuspid aortic valve repair is a safe procedure, which can be performed with acceptable midterm results. Risk of repair failure depends on preoperative valve morphology and choice of repair technique. Repair technique needs to be tailored to the specific anatomy of the valve.     

5-Year Outcomes Comparing Surgical Versus Transcatheter Aortic Valve Replacement in Patients With Chronic Kidney Disease

ObjectivesThe aim of this study was to compare 5-year cardiovascular, renal, and bioprosthetic valve durability outcomes in patients with severe aortic stenosis (AS) and chronic kidney disease (CKD) undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR).BackgroundPatients with severe AS and CKD undergoing TAVR or SAVR are a challenging, understudied clinical subset.MethodsIntermediate-risk patients with moderate to severe CKD (estimated glomerular filtration rate <60 mL/min/m²) from the PARTNER (Placement of Aortic Transcatheter Valve) 2A trial (patients randomly assigned to SAPIEN XT TAVR or SAVR) and SAPIEN 3 Intermediate Risk Registry were pooled. The composite primary outcome of death, stroke, rehospitalization, and new hemodialysis was evaluated using Cox regression analysis. Patients with and without perioperative acute kidney injury (AKI) were followed through 5 years. A core laboratory–adjudicated analysis of structural valve deterioration and bioprosthetic valve failure was also performed.ResultsThe study population included 1,045 TAVR patients (512 SAPIEN XT, 533 SAPIEN 3) and 479 SAVR patients. At 5 years, SAVR was better than SAPIEN XT TAVR (52.8% vs 68.0%; P = 0.04) but similar to SAPIEN 3 TAVR (52.8% vs 58.7%; P = 0.89). Perioperative AKI was more common after SAVR than TAVR (26.3% vs 10.3%; P < 0.001) and was independently associated with long-term outcomes. Compared with SAVR, bioprosthetic valve failure and stage 2 or 3 structural valve deterioration were significantly greater for SAPIEN XT TAVR (P < 0.05) but not for SAPIEN 3 TAVR.ConclusionsIn intermediate-risk patients with AS and CKD, SAPIEN 3 TAVR and SAVR were associated with a similar risk for the primary endpoint at 5 years. AKI was more common after SAVR than TAVR, and SAPIEN 3 valve durability was comparable with that of surgical bioprostheses.     

Esperanza de vida después del recambio valvular debido a estenosis aórtica de bajo gradiente con función ventricular conservada

Introduction and objectivesSurgical aortic valve replacement (SAVR) can modify the natural history of severe aortic stenosis (SAS). However, compared with the general population, these patients have a loss of life expectancy. The life expectancy of patients who undergo SAVR due to low-gradient SAS with preserved left ventricular ejection fraction (LVEF) is unknown.MethodsWe included all patients between 50 and 65 years who underwent isolated SAVR in 27 Spanish centers during an 18-year period. We analyzed observed and expected survival at 18 years in patients with low-gradient SAS with preserved LVEF and all other types of SAS. We used propensity score matching to compare the life expectancy of patients with low-gradient SAS with preserved LVEF vs those with high-gradient SAS with preserved LVEF.ResultsWe analyzed 5084 patients, of whom 413 had low-gradient SAS with preserved LVEF. For these patients, observed survival at 10, 15 and 18 years was 86.6% (95%CI, 85.3-87.8), 75% (95%CI, 72.7-77.2), and 63.5% (95%CI, 58.8-67.8). Expected survival at 10, 15 and 18 years was 90.2%, 82.1%, and 75.7%. In the matched sample, survival of patients with low-gradient SAS with preserved LVEF was similar to that of patients with high-gradient with preserved LVEF, log-rank test, P = .95; HR = 1 (95%CI, 0.7–1.4; P = .95).ConclusionsThere is a loss of life expectancy in patients with all types of SAS undergoing SAVR. This loss is higher in patients with left ventricular dysfunction and lower in patients with low-gradient or high-gradient aortic stenosis with preserved LVEF. The benefit of surgery is similar between these last 2 groups.     

Prótesis percutáneas autoexpandibles para la estenosis aórtica: resultados a corto plazo y comparación hemodinámica tras emparejamiento

Introduction and objectivesAortic self-expandable (SE) transcatheter aortic valve implantation (TAVI) devices are particularly useful for patients with aortic stenosis and small/tortuous vessels, small aortic annuli, or low coronary ostia. However, it is unclear whether the growing range of SE devices shows comparable hemodynamic and clinical outcomes. We aimed to determine the differential hemodynamic (residual valve area and regurgitation) and clinical outcomes of these devices in comparable scenarios.MethodsAll patients were enrolled from 4 institutions and were managed with 4 different SE TAVI devices. Baseline and follow-up clinical data were collected and echocardiographic tests blindly and centrally analyzed. Patients were compared according to valve type and a 1:1 matched comparison was performed according to degree of calcification, aortic annulus dimensions, left ventricular ejection fraction, and body surface area.ResultsIn total, 514 patients were included (Evolut R/PRO, 217; ACURATE neo, 107; ALLEGRA, 102; Portico, 88). Surgical risk scores were comparable in the unmatched population. No differences were observed in the post-TAVI regurgitation rate and in in-hospital mortality (2.7%). The rate of pacemaker implantation at discharge was significantly different among devices (P = .049), with Portico showing the highest rate (23%) and ACURATE neo the lowest (9.5%); Evolut R/PRO and ALLEGRA had rates of 15.9% and 21.2%, respectively. The adjusted comparison showed worse residual TAVI gradients and aortic valve area with ACURATE neo vs ALLEGRA (P = .001) but the latter had higher risk of valve embolization and a tendency for more cerebrovascular events.ConclusionsA matched comparison of 4 SE TAVI devices showed no differences regarding residual aortic regurgitation and in-hospital mortality.     

Progresión y predictores de insuficiencia valvular neoaórtica y dilatación de la raíz neoaórtica en adultos jóvenes tras cirugía de switch arterial

Introduction and objectivesThere are limited data on the long-term development of neoaortic root dilatation (NRD) and neoaortic valve regurgitation (AR) after arterial switch operation (ASO) for transposition of the great arteries during adult life.MethodsWe performed a retrospective longitudinal analysis of 152 patients older than 15 years who underwent ASO for transposition of the great arteries and who were followed-up for 4.9 ± 3.3 years in 2 referral centers. Sequential changes in body surface-adjusted aortic root dimensions and progression to moderate/severe AR were determined in patients with 2 or more echocardiographic examinations. Risk factors for dilatation were tested by Cox regression to identify predictors of AR progression.ResultsAt baseline, moderate AR was present in 9 patients (5.9%) and severe AR in 4 (2.6%), of whom 3 had required aortic valve surgery. Initially, the median neoaortic root dimension was 20.05 ± 2.4 mm/m², which increased significantly to 20.73 ± 2.8 mm/m² (P < .001) at the end of follow-up. The mean change over time was 0.14 mm/m²/y (95%CI, 0.07-0.2). Progressive AR was observed in 20 patients (13.5%) and 6 patients (4%) required aortic valve surgery. Progressive AR was associated with bicuspid valve, AR at baseline, NRD at baseline, and neoaortic root enlargement. Independent predictors were bicuspid valve (HR, 3.3; 95%CI, 1.1-15.2; P = .037), AR at baseline (HR, 5.9; 95%CI, 1.6-59.2; P = .006) and increase in NRD (HR, 4.1 95%CI, 2-13.5; P = .023).ConclusionsIn adult life, NRD and AR progress over time after ASO. Predictors of progressive AR are bicuspid valve, AR at baseline, and increase in NRD.     

Transcatheter edge-to-edge repair following surgical valve repair with ring implantation: Results from the multicentre “Clip-in-Ring” registry

BackgroundManagement of mitral regurgitation recurrence after failed surgical valve repair with ring implantation is controversial.AimTo describe the French experience regarding midterm safety and efficacy of transcatheter edge-to-edge mitral valve repair (TEER) in patients with failed surgical valve repair with ring implantation.MethodsThe “Clip-in-Ring” registry is a multicentre registry conducted in 11 centres in France, approved by local institutional review boards, of consecutive TEER following surgical valve repair with ring implantation. Outcomes were Mitral Valve Academic Research Consortium (MVARC) technical success, modified 30-day device and procedural success (where 10 mmHg is considered as a cut-off for significant mitral stenosis) and MVARC complications.ResultsTwenty-three patients were studied: mean age, 69 ± 10 years; male sex, 74%; EuroSCORE II, 16 ± 17; left ventricular ejection fraction, 53 ± 12%; mitral regurgitation grade 3+/4+, 17%/78%; New York Heart Association class III/IV, 47%/22%; median surgery to TEER delay, 23 (6–94) months. Technical success was 100%. At discharge, residual mitral regurgitation grade was ≤ 2+ in 87% and median transmitral gradient was 4 (3–5) mmHg. Thirty-day modified MVARC device and procedural success was 82%: four patients (17%) had residual mitral regurgitation grade > 2+, including two patients who needed complementary surgery. No patient had a 30-day transmitral gradient > 7 mmHg. No patient died or had a stroke or any life-threatening complications. One patient presented a vascular access complication requiring transfusion. No other MVARC-2 adverse event was reported.ConclusionsTEER in patients with failed mitral ring is feasible and safe. Further studies should delineate its exact role in the therapeutic armamentarium for this medical issue.     

Resultados clínicos tempranos tras el implante percutáneo de válvula aórtica por acceso transaxilar comparado con el acceso transfemoral. Datos del registro español de TAVI

Introduction and objectivesTransaxillary access (TXA) has become the most widely used alternative to transfemoral access (TFA) in patients undergoing transcatheter aortic valve implantation (TAVI). The aim of this study was to compare total in-hospital and 30-day mortality in patients included in the Spanish TAVI registry who were treated by TXA or TFA access.MethodsWe analyzed data from patients treated with TXA or TFA and who were included in the TAVI Spanish registry. In-hospital and 30-day events were defined according to the recommendations of the Valve Academic Research Consortium. The impact of the access route was evaluated by propensity score matching according to clinical and echocardiogram characteristics.ResultsA total of 6603 patients were included; 191 (2.9%) were treated via TXA and 6412 via TFA access. After adjustment (n = 113 TXA group and n = 3035 TFA group) device success was similar between the 2 groups (94%, TXA vs 95%, TFA; P = .95). However, compared with the TFA group, the TXA group showed a higher rate of acute myocardial infarction (OR, 5.3; 95%CI, 2.0-13.8); P = .001), renal complications (OR, 2.3; 95%CI, 1.3-4.1; P = .003), and pacemaker implantation (OR, 1.6; 95%CI, 1.01-2.6; P = .03). The TXA group also had higher in-hospital and 30-day mortality rates (OR, 2.2; 95%CI, 1.04-4.6; P = .039 and OR, 2.3; 95%CI, 1.2-4.5; P = .01, respectively).ConclusionsCompared with ATF, TXA is associated with higher total mortality, both in-hospital and at 30 days. Given these results, we believe that TXA should be considered only in those patients who are not suitable candidates for TFA.     

ACOD frente a AVK en pacientes con fibrilación auricular y bioprótesis: revisión sistemática y metanálisis

Introduction and objectivesDirect oral anticoagulant (DOAC) therapy has been shown to be safe and effective in patients with atrial fibrillation (AF). However, outcomes in AF patients with bioprosthetic valves are unclear, as this population has been underrepresented in clinical trials. The aim of this study was to assess the safety and efficacy of DOACs in this population based on the existing published literature.MethodsA systematic search and review were conducted to identify randomized clinical trials and comparative observational studies published from 2017 to January 2022 that compared DOACs and vitamin K antagonists (VKAs) in AF patients with bioprosthetic valves. Hazard ratios (HR) were collected to compare the 2 treatments in terms of cardiovascular and all-cause mortality, stroke/systemic embolism, and major bleeding. A meta-analysis combining the results was performed.ResultsWe included 12 studies (30 283 patients). DOACs and VKAs were compared based on HRs at the 95% confidence interval. DOAC therapy was associated with a significant 9% reduction in all-cause mortality (HR, 0.91; 95%CI, 0.85-0.97; P = .0068; I² = 8%), with no significant differences in the risk of stroke/systemic embolism (HR, 0.87; 95%CI, 0.67-1.14; P = .29; I² = 45%) or major bleeding (HR, 0.82; 95%CI, 0.67-1.00; P = .054; I² = 48.7%).ConclusionsDOAC therapy in AF patients with bioprosthetic valves may be associated with a significant reduction in all-cause mortality, with no reduction in the efficacy of stroke/systemic embolism prevention or increase in major bleeding risk.     

Factibilidad del alineamiento comisural y coronario precisos con TAVI balón-expandible

Introduction and objectivesWe aimed to describe the feasibility and preliminary outcomes of commissural alignment (CA) for the balloon-expandable transcatheter heart valve.MethodsThe relationship among native commissures and transcatheter aortic valve implantation neocommissures was analyzed in 10 consecutive patients with tricuspid severe aortic stenosis undergoing transcatheter aortic valve implantation after guided implantation based on computed tomography analysis with a self-developed software. CA was predicted by in silico bio-modelling in the 10 patients and the calculated rotation was applied during crimping. Degrees of CA and coronary overlap (CO) were measured through 1-month follow up computed tomography. Transvalvular residual gradients and the rate of paravalvular leak were also analyzed.ResultsMean commissural misalignment was 16.7 ± 8°. Four patients showed mild misalignment but none of them showed a moderate or severe degree of misalignment. The in silico model accurately predicted the final in vivo position with a correlation coefficient of 0.983 (95%CI, 0.966-0.992), P < .001. Severe CO with right coronary ostium occurred in 3 patients likely due to ostial eccentricity, and CO was not present with the left coronary artery in any of the patients. Mean transaortic gradient was 6.1 ± 3.3 mmHg and there were no moderate-severe paravalvular leaks.ConclusionsPatient-specific rotation during valve crimping based on preprocedural computed tomography is feasible with balloon-expandable devices and is associated with the absence of moderate or severe commissural misalignment and left main CO.Full English text available from:www.revespcardiol.org/en     

El cateterismo cardiaco derecho de esfuerzo predice eventos en los pacientes con estenosis aórtica degenerativa asintomática

Introduction and objectivesDegenerative aortic stenosis (DAS) is the most frequent valvular heart disease. It remains unclear how to identify asymptomatic DAS patients with normal left ventricular ejection fraction who have a high probability of event occurrence and would thus benefit from early intervention. Here, we describe a protocol for exercise hemodynamics in true asymptomatic patients with moderate or severe DAS and assess the prognostic value of the data obtained in this population.MethodsThis study involved a prospective single-centre registry of consecutive asymptomatic patients with moderate or severe DAS. Patients underwent cardiopulmonary exercise testing to confirm symptom absence during exercise and then right heart catheterization (RHC) at rest and during exercise. Events were defined as death, surgical aortic valve replacement, or transcatheter aortic valve implantation according to clinical guidelines.ResultsThirty-three patients underwent baseline and exercise RHC. The mean aortic valve area was 1.08 cm² and the aortic gradient was 39 mmHg. The mean pulmonary artery pressure was 21 mmHg with a pulmonary artery occlusion pressure of 14 mmHg and cardiac output of 5.6 L/min. The mean pulmonary artery pressure at peak exercise was 34 mmHg. After a mean follow-up of 27 months, 8 patients experienced an event (24%). There were no differences in baseline variables, aortic valve area, or cardiopulmonary exercise testing parameters between the event and event-free groups. Patients with an event did not have higher pulmonary or filling pressures after peak exercise but had lower pulmonary artery oxygen saturation on effort (median, 48% vs 57%, P = .03).ConclusionsExercise RHC is feasible and safe in this population. Peak pulmonary artery oxygen saturation might identify patients with increased risk of serious adverse events.     

Predictores e impacto pronóstico de la insuficiencia cardiaca tras el implante percutáneo de válvula aórtica con una prótesis autoexpandible

Introduction and objectivesThe purpose of this analysis was to assess the incidence, predictors and prognostic impact of acute heart failure (AHF) after transcatheter aortic valve implantation (TAVI) using a self-expanding prosthesis.MethodsFrom November 2008 to June 2017, all consecutive patients undergoing TAVI in our center were prospectively included in our TAVI registry. The predictive effect of AHF on all-cause mortality following the TAVI procedure was analyzed using Cox regression models.ResultsA total of 399 patients underwent TAVI with a mean age of 82.4 ± 5.8 years, of which 213 (53.4%) were women. During follow-up (27.0 ± 24.1 months), 29.8% (n  =  119) were admitted due to AHF, which represents a cumulative incidence function of 13.2% (95%CI, 11.1%-15.8%). At the end of follow-up, 150 patients (37.59%) had died. Those who developed AHF showed a significantly higher mortality rate (52.1% vs 31.4%; HR, 1.84; 95%CI, 1.14-2.97; P  =  .012). Independent predictors of AHF after TAVI were a past history of heart failure (P = .019) and high Society of Thoracic Surgeons score (P = .004). We found that nutritional risk index and chronic obstructive pulmonary disease were strongly correlated with outcomes in the AHF group.ConclusionsTAVI was associated with a high incidence of clinical AHF. Those who developed AHF had higher mortality. Pre-TAVI AHF and high Society of Thoracic Surgeons score were the only independent predictors of AHF in our cohort. A low nutritional risk index and chronic obstructive pulmonary disease were independent markers of mortality in the AHF group.     

Five-year mortality in patients with diabetic foot ulcer during 2009–2010 was lower than expected

AimMortality rates are decreasing in patients with diabetes. However, as this observation also concerns patients with diabetic foot ulcer (DFU), additional data are needed. For this reason, our study evaluated the 5-year mortality rate in patients with DFU during 2009–2010 and identified risk factors associated with mortality.MethodsConsecutive patients who attended a clinic for new DFU during 2009–2010 were followed until healing and at 1 year. Data on mortality were collected at year 5. Multivariate Cox proportional-hazards model was used to identify mortality risk factors.ResultsA total of 347 patients were included: mean age was 65 ± 12 years, diabetes duration was 16 [10; 27] years; 13% were on dialysis; and 7% had an organ transplant. At 5 years, 49 patients (14%) were considered lost to follow-up. Total mortality rate at 5 years was 35%, and 16% in patients with neuropathy. On multivariate analyses, mortality was positively associated with: age [hazard ratio (HR): 1.05 (1.03–1.07), P < 0.0001]; duration of diabetes [HR: 1.02 (1.001–1.03], P = 0.03]; PEDIS perfusion grade 2 vs. 1 [HR: 2.35 (1.28–4.29), P = 0.006)]; PEDIS perfusion grade 3 vs. 1 [HR: 3.14 (1.58–6.24), P = 0.001); and ulcer duration at year 1 [HR 2.09 (1.35–3.22), P = 0.0009].ConclusionMortality rates were not as high as expected despite the large number of comorbidities, suggesting that progress has been made in the health management of these patients. In particular, patients with neuropathic foot ulcer had a survival rate of 84% at 5 years.