RESUMO
BACKGROUND: The "Minimalistic Hybrid Approach" (MHA) has been proposed to reduce the invasiveness of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). AIMS: This study aims to assess whether MHA may also reduce the utilization of PCI resources (devices, radiations, and contrast) by comparing it with other conventional algorithms. METHODS: We aimed to assess the impact of MHA on device, radiation, and contrast usage during CTO-PCI analyzing data from the Belgian Working Group on CTO (BWG-CTO) registry. Patients were divided, depending on the algorithm used, into two groups: Conventional versus Minimalistic. Primary objectives were procedure performance measures such as device usage (microcatheters and guidewires), radiological parameters, and contrast use. At 1-year follow-up, patients were evaluated for target vessel failure (TVF), defined as a composite of cardiac death, new myocardial infarction, and target vessel revascularization. RESULTS: Overall, we analyzed 821 CTO-PCIs (Conventional n = 650, Minimalistic n = 171). The Minimalistic group demonstrated higher complexity of CTO lesions. After adjusting for propensity score, the Minimalistic group had a significantly lower number of microcatheters used (1.49 ± 0.85 vs. 1.24 ± 0.64, p = 0.026), while the number of guidewires was comparable (4.80 ± 3.29 vs. 4.35 ± 2.94, p = 0.30). Both groups had similar rates of success and procedural complications, as well as comparable procedural and fluoroscopic times and contrast volume used. At the 1-year follow-up, both groups showed comparable rates of TVF (hazard ratio: 0.57; 95% confidence interval: 0.24-1.34, p = 0.195). CONCLUSION: The MHA may slightly reduce the number of dedicated devices used during CTO-PCI, without adversely affecting the procedural success or long-term outcome.
Assuntos
Oclusão Coronária , Intervenção Coronária Percutânea , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Resultado do Tratamento , Oclusão Coronária/diagnóstico por imagem , Oclusão Coronária/terapia , Oclusão Coronária/etiologia , Fatores de Risco , Doença Crônica , Algoritmos , Sistema de Registros , Angiografia CoronáriaRESUMO
Left circumflex coronary artery (LCx) injury related to mitral valve surgery is a rare complication. The best treatment option is not defined, and percutaneous coronary intervention (PCI) may represent an effective treatment to avoid prolonged myocardial ischemia. To evaluate feasibility and efficacy of PCI treatment, all records of LCx injury related to mitral valve surgery and treated with PCI were included after a systematic PubMed searching. Moreover, we retrospectively analyzed our single-center PCI database and patients fulfilling the inclusion criteria were included. Patients undergoing transcatheter mitral valve intervention, non-mitral valve surgery, conservatively or surgically treated after LCx injury were excluded. Data about patient characteristics, procedural details, PCI success, and in-hospital mortality were collected. Fifty-six patients were included, 58.9% were male (n = 33) and the median age was 60.5 years (IQR = 21.75). The majority had left dominant or codominant coronary system (62.2%, n = 28 and 15.6%, n = 7, respectively). Clinical manifestations ranged from hemodynamic stability (21.1%, n = 8) to hemodynamic instability (42.1%, n = 16) and cardiac arrest (18.4%, n = 7). On ECG, 23.5% of patients (n = 12) presented ST-segment depression, 58.8% (n = 30) ST-segment elevation, 7.8% (n = 4) atrioventricular block, and 29.4% (n = 15) ventricular arrhythmias. Left ventricle dysfunction was present in 52.3% (n = 22) of patients and wall motion abnormalities in 71.4% (n = 30). PCI success rate was 82.1% (n = 46) and in-hospital mortality 4.5% (n = 2). LCx injury related to mitral surgery is a rare complication characterized by an increased risk of mortality. PCI seems a feasible treatment option, still burdened by suboptimal results, probably related to the technical challenges posed by the surgical failure.
Assuntos
Vasos Coronários , Intervenção Coronária Percutânea , Humanos , Masculino , Pessoa de Meia-Idade , Feminino , Intervenção Coronária Percutânea/efeitos adversos , Resultado do Tratamento , Estudos Retrospectivos , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgiaRESUMO
Background: The impact of nodular calcifications in left ventricular outlow tract (LVOT) and aortic annulus on the procedural outcome of transcatheter aortic valve implantation (TAVI) with new-generation devices is yet to be elucidated. Similarly, computational simulations may provide a novel insight into the biomechanical features of TAVI devices and their interaction with nodular calcifications. Methods: This retrospective single-center study included 232 patients submitted to TAVI with Evolut-R (53.4%), Portico (33.6%) and Lotus (13.0%) devices with available preoperative computed tomography (CT) angiography and evidence of nodular calcifications in aortic annulus and/or LVOT. Calcification severity was defined ≥ moderate in presence of at least two nodules or one nodule ≤ 5 mm. Three virtual simulation models of aortic root presenting a nodular calcification of increasing size were implemented. Stress distribution, stent-root contact area and paravalvular orifice area were computed. Results: At least moderate calcifications were found in 123 (53.0%) patients, with no sex differences. Among the ≥ moderate calcification group, lower device success rate was evident (87.8% vs. 95.4%; p = 0.039). Higher rates of ≥ moderate paravalvular leak (PVL) (11.4% vs. 3.7%; p = 0.028) and vascular complications (9.8% vs. 2.8%; p = 0.030) were also observed. Among the Evolut-R group, higher rates of at ≥ moderate PVL (12.1%) were observed compared to Portico (3.8%; p = 0.045) and Lotus (0.0%; p = 0.044) groups. Calcification of both annulus and LVOT (odds ratio [OR] 0.105; p = 0.023) were independent predictors of device success. On computational simulations, Portico exhibited homogeneous stress distribution by increasing calfications and overall a larger paravalvular orifice areas compared to Evolut-R and Lotus. Evolut-R showed higher values of average stress than Portico, although with a more dishomogeneous distribution leading to greater paravalvular orifice areas by severe calcifications. Lotus showed overall small paravalvular orifice areas, with no significant increase across the three models. Conclusions: At least moderate nodular calcifications in the annulus/LVOT region significantly affected TAVI outcome, as they were independent predictors of device success. Lotus and Portico seemed to perform better than Evolut-R as for device success and ≥ moderate PVL. Computational simulations revealed unique biomechanical features of the investigated devices in terms of stent compliance and radial force.
RESUMO
OBJECTIVES: To evaluate the prognostic impact of baseline tricuspid annular plane systolic excursion/pulmonary artery systolic pressure (TAPSE/PASP) ratio, as an expression of the right ventricle-pulmonary artery (RV-PA) coupling, in patients with mitral regurgitation (MR) treated with the MitraClip. BACKGROUND: Impaired RV to PA coupling is considered a marker of RV dysfunction. METHODS: From February 2016 to February 2020, a total of 165 patients were evaluated and stratified in two groups according to a prespecified value of TAPSE/PASP ratio ≤ 0.36. RESULTS: The median patients' age was 79 (men: 62.4%). Sixty-three patients (38.1%) presented TAPSE/PASP ≤ 0.36 and were then compared with patients with TAPSE/PASP > 0.36. Functional MR etiology was more frequent in TAPSE/PASP ≤ 0.36 (71.4%; p = 0.046). Acute technical success was achieved in 92.7% of the population, without any significant difference between the two groups of study and with sustained results at 30-day (device success: 85.5%; procedural success: 84.8%). On multivariate Cox regression analysis, after correction for body mass index, chronic kidney disease and left ventricle ejection fraction ≥30% but <50%, TAPSE/PASP ≤ 0.36 remained a sustained predictor of mortality and hospitalization for heart failure at one year after MitraClip (hazard ratio: 3.87; 95% confidence interval: 1.83-8.22; p ≤ 0.001). Kaplan-Meier all-cause mortality and heart failure hospitalization rates at one year were consequently higher in patients with TAPSE/PASP ≤ 0.36 (39.4% vs. 14.8%; log-rank p ≤ 0.001). CONCLUSION: Baseline TAPSE/PASP ratio seems independently associated with all-cause mortality and heart failure hospitalization after MitraClip both in functional and degenerative MR.
Assuntos
Insuficiência Cardíaca , Insuficiência da Valva Mitral , Disfunção Ventricular Direita , Ventrículos do Coração , Humanos , Masculino , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Prognóstico , Artéria Pulmonar/diagnóstico por imagem , Resultado do Tratamento , Função Ventricular DireitaRESUMO
OBJECTIVES: To evaluate the incidence of vascular complication and major bleeding in patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI) with a fully trans-wrist access (TWA) approach versus a conventional approach based on trans-femoral access (TFA). BACKGROUND: TFA is the preferred vascular access in CTO PCI, but it has been associated with a non-negligible risk of complications. METHODS: This retrospective registry included all patients undergoing CTO PCI at five institutions between July 2011 and October 2018. Patients were divided into two groups: Conventional (patients treated with at least one TFA) and Fully TWA (subjects exclusively treated with one or two TWA). The primary safety endpoint was a composite of vascular complications and major bleeding. The primary efficacy endpoint was procedural success. RESULTS: We included 1,900 patients (Conventional n = 1,496 and Fully TWA n = 404). Conventional patients showed higher occlusion complexity (J-CTO score 2.1 ± 1.2 vs. 1.5 ± 1.1, p < .001). Procedural success showed no significant difference between both groups (85.7 vs. 83.0%, p = .17). The primary safety endpoint occurred more frequently in the Conventional group (10.3 vs. 4.5%, p < .001), driven by vascular complications (9.4 vs. 3.7%, p < .001). On multivariate analysis, not using a Fully TWA approach was an independent predictor of the study endpoint, after adjusting for age, sex, diabetes, body mass index, chronic kidney disease, prior coronary artery bypass graft, and J-CTO score. CONCLUSIONS: Embracing a Fully TWA approach for CTO PCI might be associated with lower incidence of a composite endpoint of vascular complications and major bleeding, compared with a Conventional approach.
Assuntos
Cateterismo Periférico , Oclusão Coronária/terapia , Artéria Femoral , Intervenção Coronária Percutânea , Punho/irrigação sanguínea , Idoso , Cateterismo Periférico/efeitos adversos , Doença Crônica , Oclusão Coronária/diagnóstico por imagem , Europa (Continente) , Feminino , Hemorragia/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Punções , Sistema de Registros , Estudos Retrospectivos , Stents , Resultado do Tratamento , Doenças Vasculares/etiologiaRESUMO
BACKGROUND: Percutaneous recanalization of coronary chronic total occlusions (CTOs) traditionally relies on the use of dual-access and large bore catheters, with trans-femoral approach adoption in most cases. OBJECTIVES: Aim of this manuscript is to describe the outcomes of an alternative hybrid algorithm, called "Minimalistic Hybrid Algorithm," which has the purpose to minimize the use of double access, large bore catheters, and femoral approach in order to minimize the risk of vascular complications and patient's discomfort, without compromising efficacy. METHODS: In this single-center registry, a "minimalistic" approach was attempted in consecutive patients undergoing CTO PCI between March 2016 and October 2017. Data regarding the applicability of this algorithm and the related procedural success rates were collected, together with common demographic and angiographic characteristics. RESULTS: Of the 100 CTO PCI performed in the study period, 91(91%) were successfully approached according to the novel algorithm. Mean J-CTO score of all minimalistic procedures was 1.9 ± 1.2, with 31(34%) patients presenting with J-CTO score ≥3. In 52 procedures, the approach consisted of single-catheter access, 49(94.2%) of which were trans-radial. Out of the 39 patients approached with dual-catheters, 26(69.2%) were biradial, and 8(21%) radial-femoral. Procedural success in patients approached with the minimalistic algorithm was 89%, in line with the results of large-multicenter experiences nowadays available. CONCLUSIONS: Our results show that an alternative algorithm limiting the routine use of large bore catheters and trans-femoral approach is feasible in the clinical practice and yields good procedural outcomes.
Assuntos
Algoritmos , Cateterismo Periférico , Protocolos Clínicos , Oclusão Coronária/terapia , Artéria Femoral , Intervenção Coronária Percutânea , Artéria Radial , Idoso , Cateterismo Periférico/efeitos adversos , Cateterismo Periférico/instrumentação , Doença Crônica , Oclusão Coronária/diagnóstico por imagem , Oclusão Coronária/fisiopatologia , Árvores de Decisões , Desenho de Equipamento , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento , Dispositivos de Acesso VascularRESUMO
BACKGROUND: Coronary chronic total occlusions (CTO) usually coexist with diffusely diseased coronary segments proximal and/or distal to the CTO segment. During percutaneous treatment of CTO, multiple overlapping stents are often needed to treat these long lesions. OBJECTIVES: Aim of this study is to report the first use of long, tapered coronary sirolimus-eluting stents (SES) in this setting. METHODS AND RESULTS: This is a retrospective analysis of 100 consecutive patients undergoing CTO recanalization following the hybrid algorithm. Procedural success rate was 89% (11 failures). Among the successful cases, "conventional" drug-eluting stents(DES) were used in 40(44.9%) patients, while in 49(55%) patients long-tapered SES were attempted with a success rate of 98% (1 cross-over to regular stents). Total stent length in the long-tapered DES group was higher compared to the "conventional" stenting group (76 ± 28 mm vs 46 ± 22 mm, P < .001), with a similar total number of stent (1.6 ± 0.8 vs 1.9 ± 0.8). At quantitative coronary analysis, proximal and distal segment involvement was more extended in patients undergoing long-tapered stenting, with longer overall lesion length. No differences in periprocedural complications and clinical outcomes at a mean follow-up of 303 ± 179 days were observed. CONCLUSIONS: The use of long tapered coronary DES is technically feasible and safe for the percutaneous treatment of CTOs, especially for patients presenting with long lesions.
Assuntos
Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Oclusão Coronária/terapia , Stents Farmacológicos , Sirolimo/administração & dosagem , Idoso , Fármacos Cardiovasculares/efeitos adversos , Doença Crônica , Oclusão Coronária/diagnóstico por imagem , Oclusão Coronária/fisiopatologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Desenho de Prótese , Estudos Retrospectivos , Sirolimo/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução VascularRESUMO
BACKGROUND: The trans-radial approach for cardiac catheterization led to an increasing adoption of 5 French (F) catheters. We aim to evaluate reliability and reproducibility of coronary physiology assessment performed with 5F guiding catheter (GC). METHODS: Physiological measurements were performed in a coronary flow simulator, which provides two pulsatile flows, the baseline and hyperaemic flows. Two screws, positioned proximally and distally to the distal sensor of a pressure-temperature guidewire, were used to determine various combinations of stenoses and distal obstructions, simulating different pathophysiological conditions. For each setting, 5 measurements of fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microvascular resistance (IMR) were performed with 6F and 5F GCs. RESULTS: A total amount of 190 measurements were performed, 95 with 6F GC and 95 with 5F GC. Minimal differences between 6F and 5F GCs were detected for FFR [0.91 (IQR: 0.87-0.94) and 0.87 (IQR: 0.82-0.92) respectively, p < 0.001] and IMR (16.5 ± 8.8 and 15.4 ± 8.3 respectively, p = 0.001). Mean CFR was comparable between 6F and 5F GCs (3.6 ± 1.1 and 3.5 ± 0.7 respectively, p = 0.38). Misclassification rates were 1.0 %, 1.0 % and 0 % for FFR, CFR and IMR, respectively. According to Passing-Bablok analysis, an excellent agreement between 6F and 5F GCs was demonstrated for FFR and IMR, and a modest agreement for CFR. All measurements with 5F GC showed high reproducibility. CONCLUSIONS: In our in-vitro model, a complete physiological assessment including FFR, CFR and IMR resulted substantially comparable between 6F and 5F GCs. Further in-vivo analysis is required to support these findings.
Assuntos
Estenose Coronária , Reserva Fracionada de Fluxo Miocárdico , Humanos , Estenose Coronária/diagnóstico , Estenose Coronária/terapia , Reprodutibilidade dos Testes , Reserva Fracionada de Fluxo Miocárdico/fisiologia , Cateterismo Cardíaco , Catéteres , Microcirculação/fisiologia , Vasos Coronários , Angiografia Coronária , Valor Preditivo dos TestesRESUMO
The presence of collateral channels providing distal blood supply is a distinctive characteristic of chronic total occlusion (CTO) lesions. However, data about the distinct baseline and procedural characteristics of each collateral subset are scarce. Accordingly, we sought to explore the procedural aspects specific for each collateral typology (ipsilateral collaterals [ICs], contralateral collaterals [CCs] or mixed) in CTO-percutaneous coronary intervention (PCI). A retrospective analysis of our CTO-PCI registry was performed to investigate the prevalence, procedural characteristics, and outcomes specific for each CTO-PCI subset, defined according to the inter-arterial connection anatomy. A total of 209 cases were included. Of the included cases, 45 (22%) and 92 (44%) patients displayed solely IC or CC, respectively, whereas in 72 (34%) both IC and CC were present (mixed). The procedural success rate was high (91.1%) and comparable among the different groups, despite greater lesion complexity in the CC group. The most frequent target vessel was the left circumflex in the IC group (51% of cases) and the right coronary artery in the CC (63%) and mixed (57%) groups. Among the IC cases, 42% showed a poor collateral connection function (2% and 10% for the CC and mixed group, respectively), and 46% showed a suboptimal collateral recipient artery filling (21% and 20% for the CC and mixed group, respectively). Most of the IC cases were performed using a single access (96%). In conclusion, the success and complication rates were comparable among the collateral typology groups, irrespective of the differences in the baseline and procedural characteristics. Phenotyping CTO as hereby proposed might be helpful for targeted procedural considerations.
Assuntos
Oclusão Coronária , Intervenção Coronária Percutânea , Humanos , Circulação Coronária , Resultado do Tratamento , Oclusão Coronária/diagnóstico , Oclusão Coronária/epidemiologia , Oclusão Coronária/cirurgia , Estudos Retrospectivos , Prevalência , Fatores de Risco , Angiografia Coronária , Circulação Colateral , Doença Crônica , Sistema de RegistrosRESUMO
Scant data exploring potential suboptimal physiological results after angiographic successful percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) are available. Sixty cases of successful CTO-PCI were selected for this retrospective analysis. Post-CTO-PCI angiography-based fractional flow reserve was computed using the Murray-based fractional flow reserve (µFR) software. Vessel-specific µFR, residual trans-stent gradient (TSG) and corrected TSGstent were calculated. In physiological suboptimal results (µFR < 0.90), the virtual pullback pressure gradient (PPG) curves were analyzed to localize the main pressure drop-down and characterize the patterns of residual disease. The virtual pullback pressure gradient index (vPPGi) was then calculated to objectively characterize the predominant pattern of residual disease (diffuse vs focal). The physiological result was suboptimal in 28 cases (46.7%). The main pressure drop was localised proximal to the stent in 2 (7.1%), distal in 17 (60.7%) and intra-stent in 9 cases (32.2%). Intra-stent residual disease was diffuse in 7 cases and mixed in 2. Distal residual disease was characterised by a pure focal pattern in 12 cases, diffuse in 2 and mixed in 3. In the predominant diffuse phenotype (vPPGi < 0.65), we found a higher rate of TSG ≥ 0.04 (61.5% vs 20.0%, p = 0.025) and TSGstent ≥ 0.009 (46.2% vs 20.0%, p = 0.017) while in the dominant focal phenotype poor-quality distal vessel was constantly present. In our cohort, post-CTO-PCI suboptimal physiological result was frequent (46.7%). Predominant focal phenotype was constantly associated with poor-quality distal vessel, while in the predominant diffuse phenotype, the rate of TSG ≥ 0.04 and TSGstent ≥ 0.009 were significantly higher.
Assuntos
Angiografia Coronária , Oclusão Coronária , Reserva Fracionada de Fluxo Miocárdico , Intervenção Coronária Percutânea , Valor Preditivo dos Testes , Stents , Humanos , Estudos Retrospectivos , Masculino , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Feminino , Oclusão Coronária/diagnóstico por imagem , Oclusão Coronária/fisiopatologia , Oclusão Coronária/terapia , Doença Crônica , Pessoa de Meia-Idade , Idoso , Resultado do Tratamento , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/fisiopatologia , Fatores de TempoRESUMO
In transcatheter aortic valve implantation (TAVI), final device position may be affected by device interaction with the whole aortic landing zone (LZ) extending to ascending aorta. We investigated the impact of aortic LZ curvature and angulation on TAVI implantation depth, comparing short-frame balloon-expanding (BE) and long-frame self-expanding (SE) devices. Patients (n = 202) treated with BE or SE devices were matched based on one-to-one propensity score. Primary endpoint was the mismatch between the intended (HPre) and the final (HPost) implantation depth. LZ curvature and angulation were calculated based on the aortic centerline trajectory available from pre-TAVI computed tomography. Total LZ curvature ( k L Z , t o t ) and LZ angulation distal to aortic annulus ( α L Z , D i s t a l ) were greater in the SE compared to the BE group (P < 0.001 for both). In the BE group, HPost was significantly higher than HPre at both cusps (P < 0.001). In the SE group, HPost was significantly deeper than HPre only at the left coronary cusp (P = 0.013). At multivariate analysis, α L Z , D i s t a l was the only independent predictor (OR = 1.11, P = 0.002) of deeper final implantation depth with a cut-off value of 17.8°. Aortic LZ curvature and angulation significantly affected final TAVI implantation depth, especially in high stent-frame SE devices reporting, upon complete release, deeper implantation depth with respect to the intended one.
Assuntos
Estenose da Valva Aórtica , Valva Aórtica , Substituição da Valva Aórtica Transcateter , Substituição da Valva Aórtica Transcateter/métodos , Humanos , Masculino , Feminino , Idoso de 80 Anos ou mais , Idoso , Valva Aórtica/cirurgia , Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Tomografia Computadorizada por Raios X , Aorta/diagnóstico por imagem , Aorta/cirurgia , Resultado do Tratamento , Próteses Valvulares Cardíacas , Estudos RetrospectivosRESUMO
The minimalistic hybrid approach (MHA) is a recently proposed algorithm to perform chronic total occlusion (CTO) percutaneous coronary intervention (PCI), reducing the overall invasiveness of the procedure without impacting the acute results. However, data on midterm results are lacking. This study aimed to evaluate the midterm clinical outcomes of a multicenter international cohort of CTO PCI treated according to the MHA. Data from a consecutive series of patients with a CTO who underwent PCI according to the MHA between February 2019 and March 2022 were prospectively collected in 3 European centers and retrospectively analyzed. The main outcome was the first occurrence of a major adverse cardiac event (MACE), defined as a composite outcome of all-cause death, any myocardial infarction, and target vessel revascularization, at the last follow-up available. A total of 212 patients were included. The majority of the patients were symptomatic for angina (Canadian Cardiovascular Society class 2 or 3: 63.7%) at the time of the index procedure. The mean Japanese-CTO and CASTLE scores were 2.1 ± 1.2 and 2.0 ± 1.3, respectively. Technical success (CTO open with optimal flow) was achieved in 198 patients (93.9%) and procedural success (technical success without in-hospital MACEs) in 195 (91.9%). At the last follow-up available (median 677 days), the cumulative incidence rate of MACEs was 11.5%; in particular, all-cause death was 7.4%, any myocardial infarction was 4.3%, and unplanned target vessel revascularization was 6.5%. In conclusion, the midterm results of the MHA seem to be in line with contemporary results of other CTO PCI algorithms, thus potentially validating the MHA as a valuable alternative, provided that interventionalists are already expert CTO operators and accustomed to the definitions and peculiarities of MHA.
Assuntos
Oclusão Coronária , Infarto do Miocárdio , Intervenção Coronária Percutânea , Humanos , Oclusão Coronária/epidemiologia , Resultado do Tratamento , Seguimentos , Intervenção Coronária Percutânea/métodos , Estudos Retrospectivos , Canadá , Infarto do Miocárdio/complicações , Doença Crônica , Fatores de Risco , Sistema de Registros , Angiografia Coronária/efeitos adversosRESUMO
Transcatheter aortic valve implantation (TAVI) is an established treatment strategy in aortic valve disease. Infolding, as a nonuniform expansion of the prosthesis leading to introflection of part of the device circumference, is a complication specific to self-expandable prostheses. The aim of the study is to determine incidence, predictors, treatment strategy, and outcomes of infolding during Medtronic Evolut TAVI (Minneapolis, MN, US). Between January 2018 and March 2022, all patients treated with Evolut TAVI were included in a multicenter observational retrospective study. According to the occurrence of infolding, the enrolled cohort was divided into 2 groups; periprocedural characteristics and 30-day outcomes were compared. A total of 1,470 patients were included; 23 infolding cases (1.6%) were detected. Preprocedural imaging showed larger aortic anatomy and greater calcium burden in the infolding group. Infolding occurred mostly with Evolut Pro+ and size 34 mm and was diagnosed before full prosthesis release in 78.3%. The rate of moderate-to-severe paravalvular regurgitation was higher in the infolding group (21.7% vs 1.9%, p <0.001). Short-term follow-up showed greater all-cause and cardiovascular mortality (respectively, 4.3% vs 0.7% and 4.3% vs 0.6%, p <0.05) and higher rate of pacemaker implantation (33.3% vs 15.7%, p = 0.042) in case of infolding. High right cusp calcium score and resheathing maneuvers were independent predictors of infolding. In conclusion, prosthesis infolding is a TAVI complication burdened by worse cardiovascular outcomes. Prompt intraprocedural infolding diagnosis is pivotal, especially in case of great native valve calcium burden and resheathing maneuvers, to safely overcome this complication by prosthesis recapture or postdilation.
Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Desenho de Prótese , Substituição da Valva Aórtica Transcateter , Humanos , Masculino , Feminino , Estudos Retrospectivos , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/cirurgia , Incidência , Idoso , Falha de Prótese , Complicações Pós-Operatórias/epidemiologia , Valva Aórtica/cirurgia , Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/epidemiologiaRESUMO
BACKGROUND: Coronary obstruction (CO) is a potentially life-threatening complication of transcatheter aortic valve replacement (TAVR). Chimney stenting or leaflet laceration with transcatheter electrosurgery (Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction [BASILICA]) are 2 techniques developed to prevent CO. OBJECTIVES: The aim of the present study was to compare periprocedural and 1-year outcomes of chimney and BASILICA in TAVR patients at high risk of CO. METHODS: This multicenter observational registry enrolled consecutive TAVR patients at high risk of CO, undergoing either preventive chimney stenting or BASILICA. Clinical success was defined as successful performance of the chimney or BASILICA technique without clinically relevant ostial CO. The primary endpoint was major adverse cardiovascular events, a composite of death, myocardial infarction, stroke, or unplanned target lesion coronary revascularization at 1 year. RESULTS: A total of 168 patients were included: 71 (42.3%) received chimney stenting, and 97 (57.7%) underwent BASILICA. Patients undergoing BASILICA had higher preprocedural risk of CO, as indicated by lower sinotubular junction height (18.2 ± 4.8 mm vs 14.8 ± 3.4 mm; P < 0.001) and diameter (28.2 ± 4.5 vs 26.8 ± 3.4; P = 0.029). Rates of periprocedural complications were similar between the 2 groups. Clinical success was 97.2% and 96.9% in chimney and BASILICA, respectively (P = 0.92). At 1-year follow-up, the cumulative incidence of major adverse cardiovascular events was 18.7% (95% CI: 11%-30.6%) in the chimney group and 19.9% (95% CI: 12.1%-31.5%) in the BASILICA group (log-rank P = 0.848), whereas chimney was associated with a numerically higher cardiovascular mortality than BASILICA (6.7% vs 1.3%; log-rank P = 0.168). CONCLUSIONS: Chimney stenting and BASILICA effectively prevent TAVR-induced acute CO. Both techniques seem to have comparable acceptable periprocedural and 1-year outcomes.
Assuntos
Estenose da Valva Aórtica , Oclusão Coronária , Próteses Valvulares Cardíacas , Lacerações , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Lacerações/complicações , Lacerações/cirurgia , Próteses Valvulares Cardíacas/efeitos adversos , Resultado do Tratamento , Oclusão Coronária/etiologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/complicações , Desenho de PróteseRESUMO
BACKGROUND: Severe pure aortic regurgitation (AR) carries a high mortality and morbidity risk, and it is often undertreated because of the inherent surgical risk. Transcatheter heart valves (THVs) have been used off-label in this setting with overall suboptimal results. The dedicated "purpose-built" Jena Valve Trilogy (JVT, JenaValve Technology) showed an encouraging performance, although it has never been compared to other THVs. OBJECTIVES: The aim of our study was to assess the performance of the latest iteration of THVs used off-label in comparison to the purpose-built JVT in inoperable patients with severe AR. METHODS: We performed a multicenter, retrospective registry with 18 participating centers worldwide collecting data on inoperable patients with severe AR of the native valve. A bicuspid aortic valve was the main exclusion criterion. The primary endpoints were technical and device success, 1-year all-cause mortality, and the composite of 1-year mortality and the heart failure rehospitalization rate. RESULTS: Overall, 256 patients were enrolled. THVs used off-label were used in 168 cases (66%), whereas JVT was used in 88 (34%). JVT had higher technical (81% vs 98%; P < 0.001) and device success rates (73% vs 95%; P < 0.001), primarily driven by significantly lower incidences of THV embolization (15% vs 1.1%; P < 0.001), the need for a second valve (11% vs 1.1%; P = 0.004), and moderate residual AR (10% vs 1.1%; P = 0.007). The permanent pacemaker implantation rate was comparable and elevated for both groups (22% vs 24%; P = 0.70). Finally, no significant difference was observed at the 1-year follow-up in terms of mortality (HR: 0.99; P = 0.980) and the composite endpoint (HR: 1.5; P = 0.355). CONCLUSIONS: The JVT platform has a better acute performance than other THVs when used off-label for inoperable patients with severe AR. A longer follow-up is conceivably needed to detect a possible impact on prognosis.
Assuntos
Insuficiência da Valva Aórtica , Valva Aórtica , Próteses Valvulares Cardíacas , Desenho de Prótese , Sistema de Registros , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter , Humanos , Insuficiência da Valva Aórtica/fisiopatologia , Insuficiência da Valva Aórtica/mortalidade , Insuficiência da Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/etiologia , Feminino , Masculino , Estudos Retrospectivos , Idoso , Resultado do Tratamento , Idoso de 80 Anos ou mais , Fatores de Risco , Valva Aórtica/cirurgia , Valva Aórtica/fisiopatologia , Valva Aórtica/diagnóstico por imagem , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Substituição da Valva Aórtica Transcateter/instrumentação , Readmissão do Paciente , Recuperação de Função Fisiológica , Europa (Continente) , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/terapia , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/diagnóstico , HemodinâmicaRESUMO
BACKGROUND: The off-label utilization of transcatheter heart valve (THV) devices for the treatment of inoperable or high-surgical risk patients with pure native aortic valve regurgitation (NAVR) has demonstrated suboptimal outcomes, both with self- and balloon-expandable (BE) devices. The aim of this study is to compare the use of different BE scaffolds in treating pure NAVR. METHODS: Consecutive patients with pure severe NAVR who were deemed to be at high-risk and were treated with last-generation BE-THVs among seventeen Centers in Europe and US. Technical and device success rates were the primary objectives. RESULTS: Between February 2018 and July 2023, among 144 patients, 41 (28 %) received a MyVal device and 103 (72 %) were treated with a Sapien THV. Patients treated with a MyVal THV had an extra-large annulus more frequently compared to the Sapien group (49%vs.20 %, p < 0.001). Technical and device success rates were 90 % and 81 %, respectively, p > 0.1. The rate of THV migration/embolization (MyVal 4.9%vs. Sapien 11 %, p = 0.4) and second valve needed (4.9%vs.7.8 %, p = 0.7) were numerically lower in the MyVal group, whereas the rate of at least moderate paravalvular leak (15%vs.7.8 %, p = 0.2) and permanent pacemaker implantation (25%vs.18 %, p = 0.16) were numerically higher in the Myval group. CONCLUSIONS: Off-label use of BE devices for pure NAVR represents a potential alternative in high-risk patients in the absence of dedicated devices. However, BE in NAVR is associated with suboptimal outcomes. The availability of larger THV sizes may introduce transcatheter aortic valve replacement as an effective treatment for patients traditionally deemed unsuitable. NON-STANDARD ABBREVIATIONS AND ACRONYMS: AR = aortic regurgitation, BE = balloon-expandable, NAVR = native aortic valve regurgitation, PM = pacemaker, TAVR = transcatheter aortic valve replacement, THV = transcatheter heart valve, TVEM = transcatheter valve embolization and migration, VARC-3 = Valve Academic Research Consortium 3.
RESUMO
Chronic total occlusions (CTOs) are frequent in patients with previous coronary artery bypass graft (CABG) surgery. Percutaneous coronary intervention (PCI) is the usual revascularization strategy. Whether or not the presence of a graft on a CTO vessel and post-PCI graft patency impacts outcomes after CTO-PCI is unknown. We sought to evaluate the impact of post-PCI graft patency on the durability of CTO-PCI. In total, 259 patients with previous CABG who underwent CTO-PCI in 12 international centers in 2019 to 2023 were categorized into "grafted" and "ungrafted" groups based on the presence of graft on a CTO vessel. The grafted group was subdivided into "graft-occluded" and "graft-patent" groups, depending on graft patency. The primary end points were (1) technical success rate, (2) target vessel failure, and (3) CTO failure rates at 1 year. CTO failure was defined as target vessel revascularization and/or significant in-stent restenosis. A total of 199 patients (77%) were in the grafted group. Grafted CTOs showed higher complexity and lower technical success rates (70% vs 80%, p = 0.004) than nongrafted CTOs. Of the grafted CTOs, 140 (70%) were in the grafted-occluded group and 59 (30%) were in the grafted-patent group. The technical success was lower in the former group (65% vs 81%, p = 0.022). An occluded graft was an independent predictor of technical failure (odds ratio 2.04, 95% confidence interval 1.03 to 4.76, p = 0.049) and persistent post-PCI graft patency was a strong independent predictor of CTO failure at 1 year (hazard ratio 5.6, 95% confidence interval 1.2 to 27.5, log-rank p = 0.033). In conclusion, in patients with previous CABG who underwent CTO-PCI, post-PCI graft patency was a significant predictor of CTO failure.
Assuntos
Angiografia Coronária , Ponte de Artéria Coronária , Oclusão Coronária , Oclusão de Enxerto Vascular , Intervenção Coronária Percutânea , Grau de Desobstrução Vascular , Humanos , Masculino , Feminino , Ponte de Artéria Coronária/métodos , Oclusão Coronária/cirurgia , Oclusão Coronária/fisiopatologia , Idoso , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/métodos , Doença Crônica , Oclusão de Enxerto Vascular/diagnóstico por imagem , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Midterm comparative analyses of the latest iterations of the most used Evolut and SAPIEN platforms for transcatheter aortic valve implantation (TAVI) are lacking. AIMS: We aimed to compare 1-year clinical outcomes of TAVI patients receiving Evolut PRO/PRO+ (PRO) or SAPIEN 3 Ultra (ULTRA) devices in current real-world practice. METHODS: Among patients enrolled in the OPERA-TAVI registry, patients with complete 1-year follow-up were considered for the purpose of this analysis. One-to-one propensity score matching was used to compare TAVI patients receiving PRO or ULTRA devices. The primary endpoint was a composite of 1-year all-cause death, disabling stroke and rehospitalisation for heart failure. Five prespecified subgroups of patients were considered according to leaflet and left ventricular outflow tract calcifications, annulus dimensions and angulation, and leaflet morphology. RESULTS: Among a total of 1,897 patients, 587 matched pairs of patients with similar clinical and anatomical characteristics were compared. The primary composite endpoint did not differ between patients receiving PRO or ULTRA devices (Kaplan-Meier [KM] estimates 14.0% vs 11.9%; log-rank p=0.27). Patients receiving PRO devices had higher rates of 1-year disabling stroke (KM estimates 2.6% vs 0.4%; log-rank p=0.001), predominantly occurring within 30 days after TAVI (1.4% vs 0.0%; p=0.004). Outcomes were consistent across all the prespecified subsets of anatomical scenarios (all pinteraction>0.10). CONCLUSIONS: One-year clinical outcomes of patients undergoing transfemoral TAVI and receiving PRO or ULTRA devices in the current clinical practice were similar, but PRO patients had higher rates of disabling stroke. Outcomes did not differ across the different anatomical subsets of the aortic root.
Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Acidente Vascular Cerebral , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas/efeitos adversos , Resultado do Tratamento , Sistema de Registros , Acidente Vascular Cerebral/etiologia , Desenho de PróteseRESUMO
BACKGROUND: The performance of latest iteration transcatheter aortic valve replacement platforms in patients with small aortic anatomy remains underexplored. OBJECTIVES: The aim of this study was to evaluate effectiveness and performance between the self-expanding (SE) Evolut PRO and PRO+ and the balloon-expandable (BE) SAPIEN ULTRA in patients with small aortic annuli. METHODS: Data from the OPERA-TAVI (Comparative Analysis of Evolut PRO vs. SAPIEN 3 ULTRA Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry were used, with 1:1 propensity score matching. Primary endpoints included 1-year effectiveness composite (all-cause mortality, disabling stroke, or heart failure hospitalization) and 30-day device-related (hemodynamic structural valve dysfunction and nonstructural valve dysfunction) outcomes. RESULTS: Among 3,516 patients, 251 matched pairs with aortic annular area <430 mm2 were assessed. The 1-year primary effectiveness outcome did not differ significantly between cohorts (SE 10.8% vs BE 11.2%; P = 0.91). The 30-day device-oriented composite outcome was more favorable in the Evolut PRO group (SE 4.8% vs BE 10.4%; P = 0.027). Notably, SE valve recipients showed higher rates of disabling stroke (SE 4.0% vs BE 0.0%; P < 0.01) and paravalvular leaks (mild or greater: SE 48.5% vs BE 18.6% [P < 0.001]; moderate: SE 4.5% vs BE 1.2% [P = 0.070]). The BE group had higher rates of prosthesis-patient mismatch (moderate or greater: SE 16.0% vs BE 47.1% [P < 0.001]; severe: SE 1.3% vs BE 5.7% [P = 0.197]) and more patients with residual mean gradients >20 mm Hg (SE 1.0% vs BE 13.5%; P < 0.001). CONCLUSIONS: In patients with small aortic annuli, transcatheter aortic valve replacement with latest iteration devices is safe. SE platforms are associated with more favorable device performance in terms of hemodynamic structural and nonstructural dysfunction. Randomized data are needed to validate these findings and guide informed device selection.
Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Acidente Vascular Cerebral , Substituição da Valva Aórtica Transcateter , Humanos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Desenho de Prótese , Resultado do Tratamento , Sistema de Registros , Acidente Vascular Cerebral/etiologiaRESUMO
Evidence regarding gender-related differences in response to transcatheter aortic valve implantation according to the valve type is lacking. This study aimed to evaluate the impact of gender on the treatment effect of Evolut PRO/PRO+ (PRO) or SAPIEN 3 Ultra (ULTRA) devices on clinical outcomes. The Comparative Analysis of Evolut PRO vs SAPIEN 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation (OPERA-TAVI) is a multicenter, multinational registry including patients who underwent the latest-iteration PRO or ULTRA implantation. Overall, 1,174 of 1,897 patients were matched based on valve type and compared according to gender, whereas 470 men and 630 women were matched and compared according to valve type. The 30-day and 1-year outcomes were evaluated. In the PRO and ULTRA groups, men had a higher co-morbidity burden, whereas women had smaller aortic root. The 30-day (device success [DS], early safety outcome, permanent pacemaker implantation, patient-prosthesis mismatch, paravalvular regurgitation, bleedings, vascular complications, and all-cause death) and 1-year outcomes (all-cause death, stroke, and heart failure hospitalization) did not differ according to gender in both valve groups. However, the male gender decreased the likelihood of 30-day DS with ULTRA versus PRO (p for interaction = 0.047). A higher risk of 30-day permanent pacemaker implantation and 1-year stroke and a lower risk of patient-prosthesis mismatch was observed in PRO versus ULTRA, regardless of gender. In conclusion, gender did not modify the treatment effect of PRO versus ULTRA on clinical outcomes, except for 30-day DS, which was decreased in men (vs women) who received ULTRA (vs PRO).