RESUMEN

BACKGROUND: Mitral valve regurgitation (MR) is associated with worse outcomes in patients undergoing percutaneous coronary intervention (PCI). We sought to evaluate outcomes of Impella-supported high-risk PCI (HRPCI) patients according to MR severity. METHODS: Patients from the PROTECT III study undergoing Impella-supported HRPCI were stratified into 4 groups according to MR severity: No or trace MR, mild MR, moderate MR, and severe MR. Immediate PCI-related complications, major adverse cardiovascular and cerebrovascular events (MACCE: all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization) at 90 days and death at 1-year were assessed. RESULTS: From March 2017 to March 2020, 631 patients who underwent Impella-supported HRPCI in the PROTECT III study had evaluable MR severity at baseline. Patients with severe MR had lower body mass indices, lower left ventricular ejection fractions (LVEFs), and were more frequently diagnosed with heart failure. The incidence of immediate PCI-related complications was similar between groups. Unadjusted 90-day MACCE and 1-year mortality rates were numerically higher in patients with severe MR compared to the other study groups yet without reaching statistical significance. In multivariable analyses, there was no significant association between the presence of severe MR for 90-day MACCE or 1-year mortality compared with other degrees of MR (adj.HR = 1.71, 95 % CI [0.73, 3.98], p = 0.21; adj.HR = 1.79, 95 % CI [0.86, 3.74], p = 0.12, respectively). CONCLUSIONS: Impella-supported HRPCI patients with moderate or severe MR exhibited a higher prevalence of heart failure, lower LVEF, and longer hospital stays. Patients with severe MR showed numerically higher unadjusted rates of 90-day MACCE and 1-year mortality compared to other groups, however these differences did not reach statistical significance even after adjustment for potential confounders. CLINICAL TRIAL INFORMATION: Trial Name: The Global cVAD Study (cVAD). CLINICALTRIAL: govIdentifier:NCT04136392 URL: https://clinicaltrials.gov/ct2/show/NCT04136392?term=cvad&draw=2&rank=2.

RESUMEN

BACKGROUND: A prior Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry-based analysis reported similar 1-year clinical outcomes with small (20-mm) vs large (≥23-mm) balloon-expandable valves (BEV). OBJECTIVES: The aim of this study was to describe mid-term 3-year clinical outcomes for small vs large BEV and the relationship between discharge echocardiographic mean gradient (MG) and different definitions of prothesis-patient mismatch (PPM) with clinical outcomes. METHODS: Using the TVT Registry with Centers for Medicare and Medicaid Services linkage, a propensity-matched analysis of patients receiving 20- vs ≥23-mm BEVs was performed. Spline curves and Kaplan-Meier plots with adjusted HRs determined the relationship between MG and 3-year mortality. RESULTS: In total, 316,091 patients were analyzed; after propensity matching, 8,100 pairs of each group were compared. The 20-mm BEV was associated with higher MGs compared with ≥23-mm BEVs (16.2 ± 7.2 mm Hg vs 11.8 ± 5.7 mm Hg; P < 0.0001). At 3 years, there was no difference in mortality between 20- and ≥23-mm BEVs (31.5% vs 32.5%, respectively; HR: 0.97; 95% CI: 0.90-1.05). Compared with an MG of 10 to 30 mm Hg, an MG <10 mm Hg (HR: 1.25; 95% CI:1.22-1.27) was associated with increased 3-year mortality. Measured severe PPM and predicted no PPM were associated with increased 3-year mortality (33.5% vs 32.9% vs 32.1%; P < 0.0001) and (33.5% vs 31.1% vs 30%; P < 0.0001), respectively. Low MG and severe measured PPM were associated with lower left ventricular ejection fraction (LVEF). CONCLUSIONS: Patients with small-prosthesis BEVs (20 mm) had identical 3-year survival as those with larger (≥23-mm) BEV valves. Severe measured PPM and low MG (<10 mm Hg), but not predicted severe PPM, were associated with lower LVEF and increased mortality, suggesting that LVEF is the culprit for worse outcomes.

Asunto(s)

Válvula Aórtica , Valvuloplastia con Balón , Prótesis Valvulares Cardíacas , Diseño de Prótesis , Sistema de Registros , Humanos , Masculino , Femenino , Factores de Tiempo , Resultado del Tratamiento , Anciano , Factores de Riesgo , Estados Unidos , Valvuloplastia con Balón/mortalidad , Valvuloplastia con Balón/efectos adversos , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Válvula Aórtica/cirugía , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Medición de Riesgo , Hemodinámica , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/cirugía , Recuperación de la Función , Estudios Retrospectivos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/mortalidad

Asunto(s)

Prótesis Valvulares Cardíacas , Corazón Auxiliar , Humanos , Resultado del Tratamiento , Cateterismo Cardíaco/instrumentación , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Masculino , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Embolia/etiología , Embolia/diagnóstico por imagen , Embolia/terapia , Migración de Cuerpo Extraño/etiología , Migración de Cuerpo Extraño/diagnóstico por imagen , Migración de Cuerpo Extraño/terapia , Anciano , Femenino , Embolectomía

RESUMEN

Background: Post-transcatheter aortic valve replacement (TAVR), paravalvular leak (PVL) is a quality metric associated with worse clinical outcomes. Transcatheter heart valve (THV) sizing is based primarily on the systolic annular size without regard to the left ventricular outflow tract (LVOT), which also lies within the THV landing zone. We hypothesized that LVOT size relative to the annulus is associated with post-TAVR PVL. Methods: Data from consecutive patients undergoing TAVR in a single high-volume center from January 2018 to March 2019 were used. Pre-TAVR data from multidetector computed tomography (MDCT) were collected. Relative LVOT area was defined as LVOT area/annular area during systole. Logistic regression analysis was used to evaluate association with post-TAVR mild or greater PVL by transthoracic echocardiography before discharge. Results: Among 293 patients (median age, 81.1 years; female, 49.5%; White, 88.0%), 81.6% received SAPIEN 3 and 18.4% received CoreValve THV models. Aortic valve morphology was bicuspid in 10.9% of patients. Prevalence of mild or greater PVL was 23.5% (mild in 20.1%). Relative LVOT area had a significant inverse association such that the odds of mild or greater PVL decreased significantly with every 1% increase in relative LVOT area (adjusted odds ratio, 0.96; 95% CI, 0.93-0.98; P = .002). There was no interaction between the type of implanted valve and the relative LVOT area. Patients in the highest relative LVOT tertile had significantly lower odds of mild or greater PVL (adjusted odds ratio, 0.42; 95% CI, 0.21-0.87; P = .018 vs first tertile). Conclusions: In patients undergoing TAVR with the newer generation of THV (SAPIEN 3 and CoreValve models), a relatively narrower LVOT area vs annular area was independently associated with increased odds of mild or greater PVL before discharge.

RESUMEN

BACKGROUND: While transcatheter aortic valve replacement (TAVR) has broadened treatment options for critically ill patients, outcomes among those with concomitant cardiogenic shock (CS) are not well-explored. METHODS: We conducted a comprehensive search of major databases for studies comparing outcomes following TAVR in patients with and without CS since inception up to October 31, 2023. Our meta-analysis included five non-randomized observational. Dichotomous outcomes were assessed using the Mantel-Haenszel method (risk ratio, 95 % CI), and continuous outcomes were evaluated using mean difference and 95 % CI with the inverse variance method. Statistical heterogeneity was determined using the inconsistency test (I2). RESULTS: Among 26,283 patients across five studies, 30-day mortality was higher in the CS group (7267 patients; 27.6 %) compared to those without CS (OR 3.41, 95 % CI [2.01, 5.76], p < 0.01), as well as 30-day major vascular complications (OR 1.72, 95 % CI [1.54, 1.92], p < 0.01). At 1-year follow-up, there was no statistically significant difference in mortality rates between the compared groups (OR 2.68, 95 % CI [0.53, 13.46], p = 0.12). No significant between-group differences were observed in the likelihood of 30-day aortic valve reintervention (OR 3.20, 95 % CI [0.63, 16.22], p = 0.09) or post-TAVR aortic insufficiency (OR 0.91, 95 % CI [0.33, 2.51], p = 0.73). Furthermore, 30-day stroke, pacemaker implantation, and in-hospital major bleeding were comparable between both cohorts. CONCLUSION: Among patients undergoing TAVR, short-term mortality is higher but one-year outcomes are similar when comparing those with, to those without, CS. Future studies should examine whether TAVR outcomes are improved when the procedure is delayed to optimize CS and when delay is not possible, whether particular management strategies lead to more favorable periprocedural outcomes.

RESUMEN

BACKGROUND: Tricuspid regurgitation (TR) is highly prevalent in the transcatheter aortic valve replacement (TAVR) population, but clear management guidelines are lacking. OBJECTIVES: The aims of this study were to elucidate the prevalence and consequences of severe TR in patients with aortic stenosis undergoing TAVR and to examine the change in TR post-TAVR, including predictors of improvement and its impact on longer term mortality. METHODS: Using Centers for Medicare and Medicaid Services-linked TVT (Transcatheter Valve Therapy) Registry data, a propensity-matched analysis was performed among patients undergoing TAVR with baseline mild, moderate, or severe TR. Kaplan-Meier estimates were used to assess the impact of TR on 3-year mortality. Multivariable analysis identified predictors of 30-day TR improvement. RESULTS: Of the 312,320 included patients, 84% had mild, 13% moderate, and 3% severe TR. In a propensity-matched cohort, severe baseline TR was associated with higher in-hospital mortality (2.5% vs 2.1% for moderate TR and 1.8% for mild TR; P = 0.009), higher 1-year mortality (24% vs 19.6% for moderate TR and 16.6% for mild TR; P < 0.0001), and 3-year mortality (54.2% vs 48.5% for moderate TR and 43.3% for mild TR; P < 0.0001). Among the patients with severe TR at baseline, 76.4% improved to moderate or less TR 30 days after TAVR. Baseline mitral regurgitation moderate or greater, preserved ejection fraction, higher aortic valve gradient, and better kidney function predicted TR improvement after TAVR. However, severe 30-day residual TR was associated with higher 1-year mortality (27.4% vs 18.7% for moderate TR and 16.8% for mild TR; P < 0.0001). CONCLUSIONS: Severe baseline and 30-day residual TR after TAVR are associated with increased mortality up to 3 years. This analysis identifies a higher risk group that could be evaluated for the recently approved tricuspid interventions.

Asunto(s)

Estenosis de la Válvula Aórtica , Válvula Aórtica , Valvuloplastia con Balón , Prótesis Valvulares Cardíacas , Mortalidad Hospitalaria , Diseño de Prótesis , Recuperación de la Función , Sistema de Registros , Índice de Severidad de la Enfermedad , Reemplazo de la Válvula Aórtica Transcatéter , Insuficiencia de la Válvula Tricúspide , Humanos , Masculino , Femenino , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/fisiopatología , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Anciano de 80 o más Años , Resultado del Tratamiento , Insuficiencia de la Válvula Tricúspide/fisiopatología , Insuficiencia de la Válvula Tricúspide/mortalidad , Insuficiencia de la Válvula Tricúspide/diagnóstico por imagen , Insuficiencia de la Válvula Tricúspide/cirugía , Anciano , Estados Unidos/epidemiología , Factores de Riesgo , Factores de Tiempo , Válvula Aórtica/cirugía , Válvula Aórtica/fisiopatología , Válvula Aórtica/diagnóstico por imagen , Valvuloplastia con Balón/mortalidad , Valvuloplastia con Balón/efectos adversos , Medición de Riesgo , Prevalencia , Válvula Tricúspide/fisiopatología , Válvula Tricúspide/cirugía , Válvula Tricúspide/diagnóstico por imagen , Estudios Retrospectivos , Centers for Medicare and Medicaid Services, U.S. , Hemodinámica

RESUMEN

Background: Patients with complex coronary artery disease, as defined by high SYNTAX scores, undergoing percutaneous coronary intervention (PCI) have poorer outcomes when compared with patients with lower SYNTAX I scores. This study aimed to assess if mechanical circulatory support using Impella mitigates the effect of the SYNTAX I score on outcomes after high-risk percutaneous coronary intervention (HRPCI). Methods: Using data from the PROTECT III study, patients undergoing Impella-assisted HRPCI between March 2017 and March 2020 were divided into 3 cohorts based on SYNTAX I score-low (≤22), intermediate (23-32), and high (≥33). Procedural and clinical outcomes out to 90 days were compared between groups. Multivariable regression analysis was used to assess the impact of SYNTAX I score on major adverse cardiovascular and cerebrovascular events (MACCE) at 90 days. Results: A total of 850 subjects with core laboratory-adjudicated SYNTAX I scores were identified (low: n = 310; intermediate: n = 256; high: n = 284). Patients with high SYNTAX I scores were older than those with low or intermediate SYNTAX I scores (72.7 vs 69.7 vs 70.1 years, respectively; P < .01). After adjustment for covariates, high SYNTAX I score remained a significant predictor of 90-day MACCE (hazard ratio [HR], 2.14; 95% CI, 1.42-3.69; P < .01 vs low), whereas intermediate SYNTAX I score was not (HR, 0.92; 95% CI, 0.47-1.77; P = .80 vs low). These findings persisted after adjustment for post-PCI SYNTAX I score. Conclusions: A high SYNTAX I score was associated with higher rates of 90-day MACCE in patients who underwent Impella-assisted HRPCI. Further research is needed to understand the patient and procedural factors driving this finding.

RESUMEN

Background: Anemia is prevalent among patients with cardiovascular disease and is associated with adverse outcomes. However, data regarding the impact of anemia in high-risk percutaneous coronary intervention (HRPCI) are limited. Objectives: This study aimed to evaluate the impact of anemia in patients undergoing Impella-supported HRPCI in the PROTECT III study. Methods: Patients undergoing Impella-supported HRPCI in the multicenter PROTECT III study were assessed for anemia based on baseline hemoglobin levels according to World Health Organization criteria. Patients were stratified into three groups, namely, no anemia, mild anemia, and moderate or severe anemia. Major adverse cardiovascular and cerebrovascular events (MACCE: all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization) at 30 and 90 days, and major bleeding events were compared across groups. Results: Of 1,071 patients with baseline hemoglobin data, 37.9% had no anemia, 43.4% had mild anemia, and 18.7% had moderate or severe anemia. Anemic patients were older and more likely to have comorbidities. Anemia was associated with higher MACCE rates at 30 days (moderate to severe, 12.3%; mild, 9.8%; no anemia, 5.4%; p = 0.02) and at 90 days (moderate to severe, 18.7%; mild, 14.6%; none, 8.3%; p = 0.004). These differences persisted after adjustment for potential confounders at 30 and 90 days, and sensitivity analysis excluding dialysis showed similar results. Major bleeding at 30 days was also higher in anemic patients (5.5% vs. 1.2%, p = 0.002). Conclusion: Baseline anemia in Impella-supported HRPCI is common and independently associated with MACCE and major bleeding, emphasizing its significance as a prognostic factor. Specific management strategies to reduce anemia-associated MACCE risk after HRPCI should be examined. Clinical Trial Information Trial Name: The Global cVAD Study (cVAD)ClinicalTrial.gov Identifier: NCT04136392URL: https://clinicaltrials.gov/ct2/show/NCT04136392?term=cvad&draw=2&rank=2.

Asunto(s)

Aleaciones , Cateterismo Cardíaco , Dispositivo Oclusor Septal , Humanos , Resultado del Tratamiento , Cateterismo Cardíaco/instrumentación , Cateterismo Cardíaco/efectos adversos , Diseño de Prótesis , Masculino , Femenino , Embolización Terapéutica/instrumentación

RESUMEN

BACKGROUND: Prior studies have found that patients with chronic kidney disease (CKD) have worse outcomes following percutaneous coronary intervention (PCI). There are no data about patients with advanced CKD undergoing Impella-supported high-risk PCI. We, therefore, aimed to evaluate angiographic characteristics and clinical outcomes in patients with CKD who received Impella-supported high-risk PCI as part of the catheter-based ventricular assist device PROTECT III study (A Prospective, Multi-Center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump [IABP] in Patients Undergoing Non Emergent High Risk PCI). METHODS: Patients enrolled in the PROTECT III study were analyzed according to their baseline estimated glomerular filtration rate (eGFR). The primary outcome was 90-day major adverse cardiovascular and cerebrovascular events (the composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization). RESULTS: Of 1237 enrolled patients, 1052 patients with complete eGFR baseline assessment were evaluated: 586 with eGFR ≥60 mL/min per 1.73 m2, 190 with eGFR ≥45 to <60, 105 with eGFR ≥30 to <45, and 171 with eGFR <30 or on dialysis. Patients with lower eGFR (all groups with eGFR <60) were more frequently females and had a higher prevalence of hypertension, diabetes, anemia, and peripheral artery disease. The baseline Synergy Between PCI With Taxus and Cardiac Surgery score was similar between groups (28.2±12.6 for all groups). Patients with lower eGFR were more likely to have severe coronary calcifications and higher usage of atherectomy. There were no differences in individual PCI-related coronary complications between groups, but the rates of overall PCI complications were less frequent among patients with lower eGFR. Major adverse cardiovascular and cerebrovascular events at 90 days and 1-year mortality were significantly higher among patients with eGFR <30 mL/min per 1.73 m2 or on dialysis. CONCLUSIONS: Patients with advanced CKD undergoing Impella-assisted high-risk PCI tend to have higher baseline comorbidities, severe coronary calcification, and higher atherectomy usage, yet CKD was not associated with a higher rate of immediate PCI-related complications. However, 90-day major adverse cardiovascular and cerebrovascular events and 1-year mortality were significantly higher among patients with eGFR<30 mL/min per 1.73 m2 or on dialysis. Future studies of strategies to improve intermediate and long-term outcomes of these high-risk patients are warranted. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04136392.

Asunto(s)

Angiografía Coronaria , Enfermedad de la Arteria Coronaria , Tasa de Filtración Glomerular , Corazón Auxiliar , Intervención Coronaria Percutánea , Insuficiencia Renal Crónica , Humanos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Masculino , Femenino , Anciano , Insuficiencia Renal Crónica/mortalidad , Insuficiencia Renal Crónica/fisiopatología , Insuficiencia Renal Crónica/diagnóstico , Insuficiencia Renal Crónica/terapia , Estudios Prospectivos , Resultado del Tratamiento , Persona de Mediana Edad , Factores de Riesgo , Enfermedad de la Arteria Coronaria/mortalidad , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/fisiopatología , Medición de Riesgo , Factores de Tiempo , Valor Predictivo de las Pruebas , Contrapulsador Intraaórtico/efectos adversos , Contrapulsador Intraaórtico/mortalidad , Riñón/fisiopatología , Estados Unidos , Diseño de Prótesis

RESUMEN

Up to 20 % of patients presenting with acute heart failure and cardiogenic shock have a structural etiology. Despite efforts in timely management, mortality rates remain alarmingly high, ranging from 50 % to 80 %. Surgical intervention is often the definitive treatment for structural heart disease; however, many patients are considered high risk or unsuitable candidates for such procedures. Consequently, there has been a paradigm shift towards the development of novel percutaneous management strategies and temporizing interventions. This article aims to provide a comprehensive review of the pathophysiology of valvular and structural heart conditions presenting in cardiogenic shock, focusing on the evolving landscape of mechanical circulatory support devices and other management modalities.

Asunto(s)

Corazón Auxiliar , Choque Cardiogénico , Humanos , Choque Cardiogénico/terapia , Choque Cardiogénico/etiología , Atención Perioperativa/métodos , Cardiopatías , Procedimientos Quirúrgicos Cardíacos/métodos , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Insuficiencia Cardíaca/fisiopatología , Insuficiencia Cardíaca/terapia , Insuficiencia Cardíaca/cirugía

RESUMEN

BACKGROUND: The clinical efficacy and safety of alcohol septal ablation (ASA) for obstructive hypertrophic cardiomyopathy (HCM) have been well-established; however, less is known about outcomes in patients undergoing preemptive ASA before transcatheter mitral valve replacement (TMVR). AIMS: The goal of this study is to characterize the procedural characteristics and examine the clinical outcomes of ASA in both HCM and pre-TMVR. METHODS: This retrospective study compared procedural characteristics and outcomes in patient who underwent ASA for HCM and TMVR. RESULTS: In total, 137 patients were included, 86 in the HCM group and 51 in the TMVR group. The intraventricular septal thickness (mean 1.8 vs. 1.2 cm; p < 0.0001) and the pre-ASA LVOT gradient (73.6 vs. 33.8 mmHg; p ≤ 0.001) were higher in the HCM group vs the TMVR group. The mean volume of ethanol injected was higher (mean 2.4 vs. 1.7 cc; p < 0.0001). The average neo-left ventricular outflow tract area increased significantly after ASA in the patients undergoing TMVR (99.2 ± 83.37 mm2 vs. 196.5 ± 114.55 mm2; p = <0.0001). The HCM group had a greater reduction in the LVOT gradient after ASA vs the TMVR group (49.3 vs. 18 mmHg; p = 0.0040). The primary composite endpoint was higher in the TMVR group versus the HCM group (50.9% vs. 25.6%; p = 0.0404) and had a higher incidence of new permanent pacemaker (PPM) (25.5% vs. 18.6%; p = 0.3402). The TMVR group had a higher rate of all-cause mortality (9.8% vs. 1.2%; p = 0.0268). CONCLUSIONS: Preemptive ASA before TMVR was performed in patients with higher degree of clinical comorbidities, and correspondingly is associated with worse short-term clinical outcomes in comparison to ASA for HCM patients. ASA before TMVR enabled percutaneous mitral interventions in a small but significant minority of patients that would have otherwise been excluded. The degree of LVOT and neoLVOT area increase is significant and predictable.

Asunto(s)

Técnicas de Ablación , Cateterismo Cardíaco , Cardiomiopatía Hipertrófica , Etanol , Implantación de Prótesis de Válvulas Cardíacas , Válvula Mitral , Humanos , Estudios Retrospectivos , Masculino , Etanol/administración & dosificación , Etanol/efectos adversos , Cardiomiopatía Hipertrófica/diagnóstico por imagen , Cardiomiopatía Hipertrófica/mortalidad , Cardiomiopatía Hipertrófica/terapia , Cardiomiopatía Hipertrófica/cirugía , Cardiomiopatía Hipertrófica/fisiopatología , Femenino , Resultado del Tratamiento , Técnicas de Ablación/efectos adversos , Técnicas de Ablación/mortalidad , Anciano , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/mortalidad , Cateterismo Cardíaco/instrumentación , Persona de Mediana Edad , Factores de Riesgo , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Factores de Tiempo , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/fisiopatología , Válvula Mitral/cirugía , Recuperación de la Función , Anciano de 80 o más Años , Tabiques Cardíacos/diagnóstico por imagen , Tabiques Cardíacos/cirugía , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/fisiopatología , Insuficiencia de la Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/mortalidad

RESUMEN

BACKGROUND: Aortic valve lithotripsy can fragment aortic valve calcium deposits and potentially restore leaflet pliability in animal model and ex-vivo, but clinical data is limited. Transcatheter aortic valve implantation (TAVR) might not be feasible as an urgent procedure in critically ill patients. Balloon valvuloplasty has the major limitation of valve recoil and inducing aortic regurgitation. AIMS: To determine the clinical feasibility of aortic valve lithotripsy-facilitated balloon valvuloplasty in patients with severe aortic stenosis unsuitable for valvular replacement. METHODS: We performed lithotripsy as adjunctive therapy to balloon aortic valvuloplasty in ten consecutive patients, most of whom were deemed unfit for TAVR. Lithotripsy of the aortic valve was performed with simultaneous inflation of one to three peripheral lithotripsy balloons to deliver ultrasound pulses. Rapid pacing was not used during lithotripsy. Aortic valve velocity, gradient, and valve area were measured before and after the procedure by echocardiogram. Transvalvular pressure gradient was recorded intra-procedurally. Periprocedural and ninety-day clinical outcomes were followed. RESULTS: Procedure was technically successful in 9 out of 10 patients and aborted in one patient due to cardiogenic shock. One patient had femoral closure device related complication. There was a statistically significant decrease in valvular gradient and increase in aortic valve area. 9 out of 10 patients recovered from acute episode and were discharged. 6 patients had improvement in NYHA class. 4 patients were subsequently able to receive TAVR. 90-day mortality occurred in 3 patients. There was no stroke or bradyarrhythmia peri-procedurally and no heart failure hospitalization at 90 days. CONCLUSION: Aortic valve lithotripsy-facilitated balloon valvuloplasty has reasonable feasibility, safety and technical reproducibility and acute clinical result. Hemodynamic effect is similar to that of balloon valvuloplasty reported in the literature. Subsequent Prognosis is not altered in critically ill patients.

Asunto(s)

Intervención Coronaria Percutánea , Humanos , Intervención Coronaria Percutánea/métodos , Estados Unidos/epidemiología , Masculino , Femenino , Anciano , Persona de Mediana Edad , Enfermedad de la Arteria Coronaria/cirugía , Enfermedad de la Arteria Coronaria/epidemiología , Factores de Riesgo , Medición de Riesgo/métodos

Asunto(s)

Oxigenación por Membrana Extracorpórea , Choque Cardiogénico , Humanos , Choque Cardiogénico/terapia , Oxigenación por Membrana Extracorpórea/efectos adversos , Estudios de Factibilidad , Estudios Retrospectivos

Asunto(s)

Estenosis de la Válvula Aórtica , Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Anciano de 80 o más Años , Femenino , Humanos , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/fisiopatología , Aortografía , Cateterismo Periférico , Angiografía por Tomografía Computarizada , Diseño de Prótesis , Índice de Severidad de la Enfermedad , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Resultado del Tratamiento , Vena Cava Inferior/diagnóstico por imagen , Vena Cava Inferior/cirugía

Asunto(s)

Estenosis de la Válvula Aórtica , Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Humanos , Masculino , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/fisiopatología , Cateterismo Periférico , Prótesis Valvulares Cardíacas , Técnicas Hemostáticas/instrumentación , Punciones , Reoperación , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Resultado del Tratamiento

RESUMEN

Revascularization completeness after percutaneous coronary intervention (PCI) is associated with improved long-term outcomes. Mechanical circulatory support [intra-aortic balloon pump (IABP) or Impella] is used during high-risk PCI (HR-PCI) to enhance peri-procedural safety and achieve more complete revascularization. The relationship between revascularization completeness [post-PCI residual SYNTAX Score (rSS)] and left ventricular ejection fraction (LVEF) in HR-PCI has not been established. We investigated LVEF predictors at 90 days post-PCI with Impella or IABP support. Individual patient data (IPD) were analyzed from PROTECT II (NCT00562016) in the base case. IPD from PROTECT II and RESTORE-EF (NCT04648306) were naïvely pooled in the sensitivity analysis. Using complete cases only, linear regression was used to explore the predictors of LVEF at 90 days post-PCI. Models were refined using stepwise selection based on Akaike Information Criterion and included: treatment group (Impella, IABP), baseline characteristics [age, gender, race, New York Heart Association Functional Classification, LVEF, SYNTAX Score (SS)], and rSS. Impella treatment and higher baseline LVEF were significant predictors of LVEF improvement at 90 days post-PCI (p ≤ 0.05), and a lower rSS contributed to the model (p = 0.082). In the sensitivity analysis, Impella treatment, higher baseline LVEF, and lower rSS were significant predictors of LVEF improvement at 90 days (p ≤ 0.05), and SS pre-PCI contributed to the model (p = 0.070). Higher baseline LVEF, higher SS pre-PCI, lower rSS (i.e. completeness of revascularization), and Impella treatment were predictors of post-PCI LVEF improvement. The findings suggest potential mechanisms of Impella include improving the extent and quality of revascularization, and intraprocedural ventricular unloading.