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     

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.     

Patient-Specific Implantation Technique to Obtain Neo-Commissural Alignment With Self-Expanding Transcatheter Aortic Valves

ObjectivesThe authors sought to investigate whether a patient-specific implantation technique during transcatheter aortic valve replacement (TAVR) can result in a safe and reproducible neo-commissural alignment of self-expanding transcatheter heart valves (THVs).BackgroundTo date, little attention has been paid to neo-commissural alignment during TAVR.MethodsA fluoroscopy-based, patient- and valve-specific TAVR implantation technique was applied in 60 patients treated with 3 different self-expanding THV platforms (Evolut R/PRO, Medtronic; ACURATE neo2, Boston Scientific; and Portico, Abbott—20 patients in each group). Post-TAVR cardiac computed tomography was used to assess THV neo-commissural alignment.ResultsConsidering all 60 patients, ≤mild commissural misalignment (CMA <30°) was obtained in 53 patients (88%) using this modified TAVR implantation technique—in 36 patients (60%), optimal commissural alignment (<15°) was obtained. In 2 patients, cardiac computed tomography revealed severe CMA (>45°) with overlap between the coronary ostia and THV commissures. Using the ACURATE neo2 platform, operators succeeded in avoiding ≥moderate CMA in all 20 cases. When analyzing those cases in which the optimal amount of THV rotation could be assessed and applied before THV expansion (n = 52; 87%), the success rate of TAVR with ≤mild CMA was 98%. No procedure- or valve-related complications occurred in this study cohort.ConclusionsA patient-specific TAVR implantation technique aiming to obtain neo-commissural alignment is feasible and safe, and aides to prevent THV implantations with overlap between the coronary ostia and THV commissures. Optimized TAVR devices and design may further improve the success rate of TAVR with neo-commissural alignment.     

Impact of Commissural Misalignment on Hydrodynamic Function Following Valve-in-Valve Intervention With the ACURATE neo

BackgroundLimited evidence is available regarding valve-in-valve (VIV) intervention with the ACURATE neo transcatheter heart valve (THV). Low implantation has demonstrated leaflet interaction between the surgical bioprosthesis and the THV, leading to impaired hydrodynamic performance. It is unknown if commissural alignment (CA) can affect this phenomenon. Novel techniques have now been developed to achieve CA with the ACURATE neo THV.ObjectivesThe aim of this study was to assess the impact of commissural misalignment (CMA) on hydrodynamic function following VIV intervention with the ACURATE neo THV using a bench model.MethodsVIV intervention was performed with the ACURATE neo (a self-expanding THV with supra-annular leaflet position) implanted deep in the surgical bioprosthetic aortic valve (Mitroflow). Hydrodynamic function at CA (0°) and 3 different degrees of CMA (30°, 60°, and 90°) was tested. As per the International Organization for Standardization, a regurgitant fraction <20% is considered optimal.ResultsFollowing VIV, the central THV regurgitant fraction at 0°, 30°, 60°, and 90° of CMA was 8.6% ± 2.0%, 30.3% ± 12.0%, 42.6% ± 11.9%, and 66.7% ± 25.4% (P < 0.0001), respectively. On high-speed video there was no evidence of leaflet interaction at CA, whereas at 30°, 60°, and 90° of CMA there was clear evidence of THV leaflet interaction with those of the surgical valve, leading to impaired leaflet closure and to severe central THV regurgitation.ConclusionsIn VIV using the ACURATE neo THV at deep implantation, increasing degree of CMA was associated with THV leaflet interaction with those of the surgical valve and worsening regurgitant fraction. THV leaflet interaction was prevented when there was CA.     

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.     

Impacto clínico de la extensión del miocardio en riesgo en pacientes sometidos a intervención percutánea de la válvula aórtica

Introduction and objectivesCoronary artery disease (CAD) is found in 30%-50% of patients with severe aortic stenosis (AS) undergoing treatment. The best management of CAD in AS patients undergoing transcatheter aortic valve implantation (TAVI) is still unclear. We investigated the clinical impact of the extent of jeopardized myocardium in patients with concomitant CAD and severe AS treated by TAVI.MethodsConsecutive patients who underwent TAVI procedures at our hospital were identified. In the presence of CAD, the myocardium jeopardized before TAVI was graded using the British Cardiovascular Intervention Society (BCIS) jeopardy score (JS). The study population was divided in 3 groups: patients without concomitant CAD (no-CAD), patients with CAD and BCIS-JS ≤ 4 (CAD BCIS-JS ≤ 4) and patients with concomitant CAD and BCIS-JS > 4 (CAD BCIS-JS > 4). The primary study endpoint was major adverse cardiovascular and cerebrovascular events (MACCE).ResultsA total of 403 patients entered the study: 223 no-CAD, 94 CAD BCIS-JS ≤ 4 and 86 CAD BCIS-JS > 4. At > 3 months of follow-up [range 104–3296 days], patients without CAD and CAD patients with BCIS-JS ≤ 4 had better survival free from MACCE compared with those with less extensive revascularization (BCIS-JS > 4) (P = .049). This result was driven by a significant reduction in death (P = .031). On multivariate analysis, residual BCIS-JS ≤ 4 and NYHA class III-IV independently predicted MACCE.ConclusionsIn patients with concomitant CAD and severe AS, the extent of jeopardized myocardium before TAVI impacts on clinical 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.     

Valor pronóstico diferencial de la galectina-3 según los valores de antígeno carbohidrato 125 para el implante percutáneo de válvula aórtica

Introduction and objectivesGalectin-3 (Gal-3) and carbohydrate antigen 125 (CA125) have been associated with adverse outcomes after transcatheter aortic valve implantation (TAVI). Experimental data have suggested a potential molecular interaction. Therefore, we assessed the association of Gal-3 and CA125 with prognosis after TAVI.MethodsA total of 439 patients were enrolled. The primary endpoint was a composite of all-cause mortality or readmission for worsening heart failure after TAVI.ResultsThe primary endpoint occurred in 16.4%. Gal-3 was dichotomized at ≥ 8.71 ng/mL into elevated and not elevated. Gal-3 was elevated in 31.9% and was associated with a higher risk of the primary endpoint (25% vs 12.4%, HR, 2.26; P < .001). After multivariable adjustment, the association of elevated Gal-3 with the primary endpoint was borderline significant (HR, 1.59; P = .068). CA125 was dichotomized at ≥ 18.4 U/mL, accordingly. CA125 was elevated in 51.9% and was also associated with a higher risk of the primary endpoint (25.4% vs 6.6%, HR, 4.20; P < .001). After multivariable adjustment, elevated CA125 (HR, 2.83; P = .001) remained independently associated with the primary endpoint. A differential prognostic effect of Gal-3 was found across CA125 status (P for interaction = .048). Elevated Gal-3 was associated with a higher risk of the primary endpoint when CA125 was elevated (38.8% vs 18.2%, HR, 2.02; P = .015) but lacked significance when CA125 was not elevated (6.6% vs 6.7%, HR, 1.16; P = .981).ConclusionsIn patients undergoing TAVI, Gal-3 predicted adverse clinical outcomes only when CA125 was elevated.     

Valve-in-Valve Implantation Using the ACURATE Neo in Degenerated Aortic Bioprostheses: An International Multicenter Analysis

ObjectivesThis study reports an international experience using the transfemoral ACURATE neo transcatheter heart valve (Boston Scientific, Marlborough, Massachusetts) for the treatment of degenerated surgical aortic bioprostheses.BackgroundTranscatheter valve-in-valve procedures have emerged as an alternative to redo surgery. Supra-annular prostheses might be particularly useful in this indication.MethodsThis is an international multicenter analysis including 85 patients from 14 centers in Europe and Canada undergoing an ACURATE neo valve-in-valve procedure from March 2015 to February 2019.ResultsInternal diameter of the degenerated bioprosthesis was 20.3 ± 2.1 mm. Prosthesis size S was used in 70 (82%) procedures. The median depth of implantation was 3 mm and the upper crown of the ACURATE neo was positioned above the stent posts of the degenerated bioprosthesis in 54 (64%) and inside in 31 (36%). Mean transvalvular gradient before discharge was significantly lower if the upper crown was above the degenerated bioprosthesis (13.7 ± 5.9 mm Hg vs. 19.5 ± 10.0 mm Hg; p = 0.001). However, a high position of the ACURATE neo resulted in embolization in 1 patient, conversion to open-heart surgery in 1, and need for reintervention due to transcatheter heart valve failure within the first 18 months of follow-up in 4.ConclusionsThis early experience shows that a high implantation of the ACURATE neo with the upper crown above the stent posts of the degenerated bioprosthesis resulted in lower mean transvalvular gradients but a higher rate of malpositioning and early valve degeneration.     

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.     

La técnica de superposición de cúspides en TAVI con dispositivo autoexpandible optimiza la profundidad del implante y reduce la necesidad de marcapasos permanente

Introduction and objectivesThis study aimed to determine the safety and efficacy of modifying the classic implantation technique for aortic transcatheter heart valve (THV) implantation to a cusp-overlap-projection (COP) technique to achieve a higher implantation depth and to reduce the burden of new permanent pacemaker implantation (PPMI) at 30 days. Aortic self-expanding THV carries an elevated risk for PPMI. A higher implantation depth minimizes the damage in the conduction system and may reduce PPMI rates.MethodsFrom March 2017, 226 patients were consecutively included: 113 patients were treated using the COP implantation technique compared with the previous 113 consecutive patients treated using the classic technique. In all patients, implantation depth was assessed by 3 methods (noncoronary cusp to the THV, mean of the noncoronary cusp and the left coronary cusp to the THV, and the deepest edge from the left coronary cusp and the noncoronary cusp to the THV).ResultsThe COP group had a lower implantation depth than the group treated with the classic technique (4.8 mm ± 2.2 vs 5.7 mm ± 3.1; P = .011; 5.8 mm ± 3.1 vs 6.5 mm ± 2.4; P = .095; 7.1 mm ± 2.8 vs 7.4 mm ± 3.2; P = .392). Forty patients (17.7%) required a new PPMI after the 30-day follow-up but this requirement was significantly lower in the COP group (12.4% vs 23%, P = .036). The COP implantation technique consistently protected against the main event (OR, 0.45; 95%CI, 0.21-0.97; P = .043), with similar procedural success rates and complications.ConclusionsThe COP implantation technique is a simple modification of the implantation protocol and provides a higher implantation depth of self-expanding-THV with lower conduction disturbances and PPMI rates.     

Resultados en España de la encuesta de la Sociedad Europea de Cardiología sobre terapia de resincronización cardiaca (CRT-Survey II)

Introduction and objectivesWe describe the results for Spain of the Second European Cardiac Resynchronization Therapy Survey (CRT-Survey II) and compare them with those of the other participating countries.MethodsWe included patients undergoing CRT device implantation between October 2015 and December 2016 in 36 participating Spanish centers. We registered the patients’ baseline characteristics, implant procedure data, and short-term follow-up information until hospital discharge.ResultsImplant success was achieved in 95.9%. The median [interquartile range] annual implantation rate by center was significantly lower in Spain than in the other participating countries: 30 implants/y [21-50] vs 55 implants/y [33-100]; P = .00003. In Spanish centers, there was a lower proportion of patients ≥ 75 years (27.9% vs 32.4%; P = .0071), a higher proportion in NYHA class II (46.9% vs 36.9%, P < .00001), and a higher percentage with electrocardiographic criteria of left bundle branch block (82.9% vs 74.6%; P < .00001). The mean length of hospital stay was significantly lower in Spanish centers (5.8 ± 8.5 days vs 6.4 ± 11.6; P < .00001). Spanish patients were more likely to receive a quadripolar LV lead (74% vs 56%, P < .00001) and to be followed up by remote monitoring (55.8% vs 27.7%; P < .00001).ConclusionsThe CRT-Survey II shows that, compared with other participating countries, fewer patients in Spain aged ≥ 75 years received a CRT device, while more patients were in New York Heart Association functional class II and had left bundle branch block. In addition, the length of hospital stay was shorter, and there was greater use of quadripolar LV leads and remote CRT monitoring.Full English text available from:www.revespcardiol.org/en     

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.     

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.     

Impact of procedural success on clinical outcome after MitraClip: Results from the MITRA-FR trial

BackgroundDifferences in procedural success rates have been proposed to explain the divergent results between the MITRA-FR trial (Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation) and the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation).AimTo examine whether MITRA-FR patients who had successful clip implantation achieved a better outcome than the control group.MethodsBased on the per protocol population of MITRA-FR, we compared the outcome in 71 patients in whom optimal clip implantation was achieved (group 1: mitral regurgitation grade ≤ 1 + at discharge) with that in 23 patients with non-optimal clip implantation (group 2: mitral regurgitation grade ≥ 2 + at discharge) and that in 137 patients in the control group (group 3). The primary endpoint was all-cause death or unplanned hospitalization for heart failure at 24 months.ResultsEvent-free survival was not different across the groups (42 ± 6% in group 1, 30 ± 10% in group 2 and 31 ± 4% in group 3; log-rank P = 0.32). In multivariable analyses, after adjustment for age, sex, rhythm, aetiology, left ventricular ejection fraction and mitral regurgitation severity, group was not associated with variations in outcome: using Group 3 as reference, hazard ratio 0.86, 95% confidence interval 0.58–1.27 (P = 0.43) in group 1; and hazard ratio 0.98 95% confidence interval 0.54–1.76 (P = 0.94) in group 2.ConclusionsThe clinical outcome of patients in whom optimal procedural result was achieved at discharge was not different compared with the control group. Our results do not support the hypothesis that the differences in rates of residual mitral regurgitation at discharge between MITRA-FR and COAPT explain the divergent results between the two trials.     

Comparación de seguridad y efectividad entre los accesos radiales derecho e izquierdo en la intervención coronaria percutánea

Introduction and objectivesThere is a paucity of data comparing the left radial approach (LRA) and right radial approach (RRA) for percutaneous coronary intervention (PCI) in all-comers populations and performed by operators with different experience levels. Thus, we sought to compare the safety and clinical outcomes of the RRA and LRA during PCI in “real-world” patients with either stable angina or acute coronary syndrome (ACS).MethodsTo overcome the possible impact of the nonrandomized design, a propensity score was calculated to compare the 2 radial approaches. The study group comprised 18 716 matched pairs with stable angina and 46 241 with ACS treated with PCI and stent implantation between 2014 and 2017 in 151 tertiary invasive cardiology centers in Poland (the ORPKI Polish National Registry).ResultsThe rates of death and periprocedural complications were similar for the RRA and LRA in stable angina patients. A higher radiation dose was observed with PCI via the LRA in both clinical presentations (stable angina: 1067.0 ± 947.1 mGy vs 1007.4 ± 983.5 mGy, P = .001; ACS: 1212.7 ± 1005.5 mGy vs 1053.5 ± 1029.7 mGy, P = .001). More contrast was used in LRA procedures but only in ACS patients (174.2 ± 75.4 mL vs 167.2 ± 72.1 mL, P = .001). Furthermore, periprocedural complications such as coronary artery dissection (0.16% vs 0.09%, P = .008), no-reflow phenomenon (0.65% vs 0.49%, P = .005), and puncture site bleeding (0.09% vs 0.05%, P = .04) were more frequently observed with the LRA in ACS patients. There was no difference in mortality between the 2 groups (P = .90).ConclusionsOur finding of poorer outcomes with the LRA may be related to lower operator experience with this approach. While both the LRA and RRA are safe in the setting of stable angina, the LRA was associated with a higher rate of periprocedural complications during PCI in ACS patients.Full English text available from:www.revespcardiol.org/en     

Efectos del tratamiento médico guiado en pacientes con miocardiopatía inducida por bloqueo de rama izquierda

Introduction and objectivesLeft bundle branch block (LBBB)-induced cardiomyopathy occurs in patients with long-standing LBBB. These patients characteristically exhibit hyperresponsiveness to cardiac resynchronization therapies (CRT). However, there is scarce information on their response to medical treatment. The aim of this study was to assess the change in left ventricular ejection fraction (LVEF) after a 3-month period following titration of guideline-directed medical therapy for heart failure.MethodsThis retrospective analysis included all patients assessed in the heart failure unit of a Spanish University Hospital between 2020 and 2021, who presented with de novo ventricular dysfunction (LVEF < 40%) and had a history of long-standing LBBB with no other possible causes of cardiomyopathy.ResultsA total of 1497 patients were analyzed, of which 21 were finally eligible. Mean time from first diagnosis of LBBB to first consultation was 4.05 ± 4.1 years. Mean LVEF from first consultation to end of titration improved from 29.5 ± 5.7% to 32.7 ± 8.6% (P = .172), but none had recovered ventricular function at the end of follow-up. New York Heart Association functional class improved from 1.91 ± 0.46 to 1.81 ± 0.53 (P = .542). After CRT device implantation in 8 patients, LVEF improved by 18.1 ± 6.4% (P = .003).ConclusionsGuideline-directed medical therapy seems to be ineffective in improving LVEF and functional class in patients with de novo heart failure and LBBB-induced cardiomyopathy. Based on a positive response to CRT on LVEF improvement, early CRT implantation could be a reasonable strategy for these patients.Full English text available from:www.revespcardiol.org/en     

Effect of maternal lifestyle intervention on metabolic health and adiposity of offspring: Findings from the Finnish Gestational Diabetes Prevention Study (RADIEL)

AimTo assess in women at high risk of gestational diabetes mellitus (GDM) the effect of a lifestyle intervention on the metabolic health of their offspring around 5 years after delivery.MethodsFor the original Finnish gestational diabetes prevention study (RADIEL), 720 women with a prepregnancy body mass index (BMI) ≥ 30 kg/m² and/or previous GDM were enrolled before or during early pregnancy and allocated to either an interventional (n = 126) or conventional (n = 133) care group. The present 5-year follow-up substudy assessed the metabolic health outcomes of their offspring. Age- and gender-standardized residuals of metabolic health components (waist circumference, mean arterial pressure, high-density lipoprotein and triglyceride levels, and fasting insulin/glucose ratio) were also combined to determine the accumulation of metabolic effects. Body composition was assessed by electrical bioimpedance.ResultsOffspring of women in the intervention group had a less optimal metabolic profile after the 5-year follow-up compared with offspring in the usual care group (P = 0.014). This difference in metabolic health was primarily related to lipid metabolism, and was more prominent among boys (P = 0.001) than girls (P = 0.74). Neither GDM, gestational weight gain, prepregnancy BMI, offspring age nor timing of randomization (before or during pregnancy) could explain the detected difference, which was also more pronounced among the offspring of GDM pregnancies (P = 0.010). Offspring body composition was similar in both groups (P > 0.05).ConclusionThe lifestyle intervention aimed at GDM prevention was associated with unfavourable metabolic outcomes among offspring at around 5 years of age.     

Metabolic and psychological effects of short-term increased consumption of less-processed foods in daily diets: A Pilot Study

AimThis study evaluated whether the consumption of locally produced food without additives might have a positive effect on known risk factors for non-communicable diseases (NCDs) such as hypertension, and levels of fasting glucose and visceral adipose tissue (VAT). Attention was focused on various types of cheese, sausages, fresh pasta, pastries, biscuits and chocolate without additives to make them palatable and durable for transport.MethodsHealthy volunteers were randomized to purchase the foods under study from either local producers not using additives (group 1) or supermarkets (group 2). At baseline and after 6 months, both groups underwent evaluation for weight, blood pressure, VAT, serum sodium, potassium, fasting glucose, insulin, C-peptide and creatinine levels, and also the State-Trait Anxiety Inventory (STAI) and Beck Depression Inventory (BDI-II) by examiners blinded to group allocation. At baseline, the state part of the STAI and Wechsler Adult Intelligence Scale IV were also performed, and body mass index, HOMA index and estimated glomerular filtration rate calculated.ResultsData for 159 subjects (89 in group 1, 70 in group 2) were analyzed. Baseline evaluations did not differ between groups. At 6 months, HOMA scores and fasting glucose levels were lower in group 1 than in group 2 (P < 0.01). Also, in group 1, VAT (P = 0.006), systolic blood pressure (P = 0.001) and BDI-II score (P = 0.0005) were decreased, whereas serum fasting glucose (P = 0.04) and C-peptide (P = 0.03) levels, and diastolic blood pressure (P = 0.02), were increased in group 2.ConclusionConsumption of the locally produced food under study improved some of the major risk factors for NCDs after 6 months.     

The impact of antiviral therapy for HCV on kidney disease: a systematic review and meta-analysis

BackgroundControversy persists about the role of hepatitis C as a risk factor for developing kidney disease in the general population. Some authors have evaluated the effect of antiviral therapy for HCV on the risk of kidney disease.Study Aims and DesignA systematic review of the published medical literature was performed to assess whether antiviral therapy for HCV has an independent impact on kidney survival in the adult general population. A random effects model was used to generate an overall estimate of the risk of kidney disease after anti-HCV therapy across the published studies. Meta-regression and stratified analysis were also carried out.ResultsFifteen studies were eligible (n = 356, 285 patients) and separate meta-analyses were conducted according to the outcome. Pooling studies based on viral responses (n = 7; 34,763 individual patients) demonstrated a relationship between sustained viral response and lower frequency of kidney disease; the overall estimate for adjusted risk of kidney disease was 2.50 (95% CI, 1.41; 4.41) (p = 0.0016) and between-study heterogeneity was found (p-value by Q test = 0.004). Aggregation of studies comparing treated vs untreated cohorts (n = 8, n = 333,312 patients) revealed an association between anti-HCV therapy and lower risk of kidney disease. The overall estimate for adjusted risk of kidney disease across the eight studies was 0.39 (95% CI, 0.25; 0.612) (p = 0.0001). Meta-regression showed that the effectiveness of antiviral therapy in reducing the frequency of kidney disease diminishes as cirrhosis (p = 0.02) and HBV infection (p = 0.0001) increase among HCV-infected individuals.ConclusionsAntiviral therapy for HCV lowers the risk of kidney disease among HCV-infected individuals. Studies to understand the mechanisms underlying this association are ongoing.