Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis in patients at high or prohibitive surgical risk. Nevertheless, long-term clinical and ...echocardiographic data are still lacking. We carried out an analysis of 560 consecutive patients who underwent TAVI at our institution from 2008 to 2016 to evaluate temporal changes in TAVI characteristics, predictors of 1-year and long-term outcomes, and to compare the performance of the early- and new-generation valve systems. With time, we have adopted lower risk threshold for patient selection and have been using conscious sedation and transfemoral access preferentially (p <0.001 for all). The incidence of greater than mild PVL decreased from 16% to 7.6%, p = 0.029. Within 5 years, 47% of the patients died, the majority (78%) due to noncardiac causes. Independent predictors of 1-year death included periprocedural aspects (i.e., vascular complications, stroke, and PVL), whereas death occurring later than 1 year was solely related to baseline co-morbidities. Transvalvular gradients and residual regurgitation remained nonclinically significant for up to 5 years of follow-up. New-generation valves were associated with less PVL compared with propensity score–matched early-generation valves (p <0.001). In conclusion, TAVI utilization at our institution has progressed to include lower risk patients with transfemoral access becoming applicable in the great majority. Poor long-term survival is attributable to population factors rather than to procedural factors. Intermediate- and long-term hemodynamics are excellent. PVL has diminished significantly with the new-generation valves. Efforts to improve long- and short-term outcomes remain a therapeutic challenge.
Guideline-directed medical therapies for heart failure (HF) may benefit patients with reduced left ventricular ejection fraction (LVEF) following acute coronary syndromes (ACS). Few real-world data ...are available regarding the early implementation of HF therapies in patients with ACS and reduced LVEF.
Data collected from the 2021 nationwide, prospective ACS Israeli Survey (ACSIS). Drug classes included: (a) angiotensin-converting enzyme inhibitors (ACEI), angiotensin receptor blockers (ARB) or angiotensin receptor-neprilysin inhibitors (ARNI); (b) beta-blockers; (c) mineralocorticoid receptor antagonist (MRA) and (d) sodium-glucose cotransporter-2 inhibitors (SGLT2I). The utilization of HF therapies at discharge or 90 days following ACS was analyzed in relation to LVEF reduced ≤40% (
= 406) or mildly-reduced 41-49% (
= 255) and short-term adverse outcomes.
History of HF, anterior wall myocardial infarction and Killip class II-IV (32% vs. 14%
< 0.001) were more prevalent in those with reduced compared to mildly-reduced LVEF. ACEI/ARB/ARNI and beta-blockers were used by the majority of patients in both LVEF groups, though ARNI was prescribed to only 3.9% (LVEF ≤ 40%). MRA was used by 42.9% and 12.2% of patients with LVEF ≤40% and 41-49%, respectively, and SGLT2I in about a quarter of both LVEF groups. Overall, ≥3 HF drug classes were documented in 44% of the patients. A trend towards higher rates of 90-day HF rehospitalizations, recurrent ACS or all-cause death was noted in those with reduced (7.6%) vs. mildly-reduced (3.7%) LVEF,
= 0.084. No association was observed between the number of HF drug classes or the use of ARNI and/or SGLT2I with adverse clinical outcomes.
In current clinical practice, the majority of patients with reduced and mildly-reduced LVEF are treated by ACEI/ARB and beta-blockers early following ACS, whereas MRA is underutilized and the adoption of SGLT2I and ARNI is low. A greater number of therapeutic classes was not associated with reduced short-term rehospitalizations or mortality.
Introduction: Transcatheter Aortic Valve Implantation (TAVI) has emerged as a common and effective treatment for patients with severe aortic stenosis. Changes in systemic blood pressure after TAVI ...have been described, yet their prognostic value are not established. Thus, we aimed to examine the association of the peri-procedural changes in systolic blood pressure and in pulse pressure on clinical outcomes after the procedure. Methods: A retrospective study of consecutive patients who underwent TAVI procedure in our medical center. We assessed the effect of the periprocedural changes in blood pressure measurements on mortality, acute myocardial infarction, stroke and hospitalizations at 1-year and on the combined outcome of death, myocardial infarction and stroke at one year following the procedure. Results: Our cohort included 455 patients (44% males). Of them, 343 patients (75.4%) have raised the systolic blood pressure (SBP) immediately after the procedure. Patients who raised SBP had a significantly higher rate of the 1-year composite outcome, compared to patients who did not raise SBP following the procedure (43 13% vs 6 5.4%, respectively, p=0.033). After adjustment for age and sex, the postprocedural increase in SBP was significantly associated with the composite outcome, with a hazard ratio of 2.42, 95% CI 1.03-5.7. Conclusion: An immediate increase in SBP after TAVI is associated with worse 1-year clinical cardiovascular outcomes.
Cardiogenic shock (CS) remains the leading cause of ST elevation myocardial infarction (STEMI)-related mortality. Contemporary studies have shown no sex-related differences in mortality.
STEMI-CS ...patients undergoing primary percutaneous coronary intervention (PPCI) were included based on a dedicated prospective STEMI database. We compared sex-specific differences in CS characteristics at baseline, during hospitalization, and in subsequent clinical outcomes. Endpoints included all-cause mortality and major adverse cardiac events (MACE).
Of 3202 consecutive STEMI patients, 210 (6.5%) had CS, of which 63 (30.0%) were women. Women were older than men (73.2 vs. 65.5% y,
< 0.01), and more had hypertension (68.3 vs. 52.8%,
= 0.019) and diabetes (38.7 vs. 24.8%,
= 0.047). Fewer were smokers (13.3 vs. 41.2%,
< 0.01), had previous PCI (9.1 vs. 22.3%
= 0.016), or required IABP (35.3 vs. 51.1%
= 0.027). Women had higher rates of mortality (53.2 vs. 35.3% in-hospital,
= 0.01; 61.3 vs. 41.9% at 1 month,
= 0.01; and 73.8 vs. 52.6% at 3 years,
= 0.05) and MACE (60.6 vs. 41.6% in-hospital,
= 0.032; 66.1 vs. 45.6% at 1 month,
= 0.007; and 62.9 vs. 80.3% at 3 years,
= 0.015). After multivariate adjustment, female sex remained an independent factor for death (HR-2.42 95% CI 1.014-5.033,
= 0.042) and MACE (HR-1.91 95% CI 1.217-3.031,
= 0.01).
CS complicating STEMI is associated with greater short- and long-term mortality and MACE in women. Sex-focused measures to improve diagnosis and treatment are mandatory for CS patients.
Diabetes Mellitus (DM) affects a third of patients with symptomatic severe aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI). DM is a well-known risk factor for cardiac ...surgery, but its prognostic impact in TAVI patients remains controversial. This study aimed to evaluate outcomes in diabetic patients undergoing TAVI.
This multicentre registry includes data of > 12,000 patients undergoing transfemoral TAVI. We assessed baseline patient characteristics and clinical outcomes in patients with DM and without DM. Clinical outcomes were defined by the second valve academic research consortium. Propensity score matching was applied to minimize potential confounding.
Of the 11,440 patients included, 31% (n = 3550) had DM and 69% (n = 7890) did not have DM. Diabetic patients were younger but had an overall worse cardiovascular risk profile than non-diabetic patients. All-cause mortality rates were comparable at 30 days (4.5% vs. 4.9%, RR 0.9, 95%CI 0.8-1.1, p = 0.43) and at one year (17.5% vs. 17.4%, RR 1.0, 95%CI 0.9-1.1, p = 0.86) in the unmatched population. Propensity score matching obtained 3281 patient-pairs. Also in the matched population, mortality rates were comparable at 30 days (4.7% vs. 4.3%, RR 1.1, 95%CI 0.9-1.4, p = 0.38) and one year (17.3% vs. 16.2%, RR 1.1, 95%CI 0.9-1.2, p = 0.37). Other clinical outcomes including stroke, major bleeding, myocardial infarction and permanent pacemaker implantation, were comparable between patients with DM and without DM. Insulin treated diabetics (n = 314) showed a trend to higher mortality compared with non-insulin treated diabetics (n = 701, Hazard Ratio 1.5, 95%CI 0.9-2.3, p = 0.08). EuroSCORE II was the most accurate risk score and underestimated 30-day mortality with an observed-expected ratio of 1.15 in DM patients, STS-PROM overestimated actual mortality with a ratio of 0.77 and Logistic EuroSCORE with 0.35.
DM was not associated with mortality during the first year after TAVI. DM patients undergoing TAVI had low rates of mortality and other adverse clinical outcomes, comparable to non-DM TAVI patients. Our results underscore the safety of TAVI treatment in DM patients.
The study is registered at clinicaltrials.gov (NCT03588247).
Purpose: To evaluate the role of diabetes mellitus in the incidence, risk factors, and outcomes of AKI (acute kidney injury) in patients admitted with ACS (acute coronary syndrome). Methods: We ...performed a comparative evaluation of ACS patients with vs. without DM who developed AKI enrolled in the biennial ACS Israeli Surveys (ACSIS) between 2000 and 2018. AKI was defined as an absolute increase in serum creatinine (≥0.5 mg/dL) or above 1.5 mg/dL or new renal replacement therapy upon admission with ACS. Outcomes included 30-day major adverse cardiovascular events (MACE) and 1-year all-cause mortality. Results: The current study included a total of 16,879 patients, median age 64 (IQR 54–74), 77% males, 36% with DM. The incidence of AKI was significantly higher among patients with vs. without DM (8.4% vs. 4.7%, p < 0.001). The rates of 30-day MACE (40.8% vs. 13.4%, p < 0.001) and 1-year mortality (43.7% vs. 10%, p < 0.001) were significantly greater among diabetic patients who developed vs. those who did not develop AKI respectively, yet very similar among patients that developed AKI with vs. without DM (30-day MACE 40.8% vs. 40.3%, p = 0.9 1-year mortality 43.7 vs. 44.8%, p = 0.8, respectively). Multivariate analyses adjusted to potential confounders, showed similar independent predictors of AKI among patients with and without DM, comprising; older age, chronic kidney disease, congestive heart failure, and peripheral arterial disease. Conclusions: Although patients with DM are at much greater risk for AKI when admitted with ACS, the independent predictors of AKI and the worse patient outcomes when AKI occurs, are similar irrespective to DM status.
Aims The aim of this study is to determine the most accurate renal function formula that predicts short- and long-term mortality in a wide spectrum of acute coronary syndrome (ACS) patients. Methods ...and results We analyzed 8,726 consecutive patients (46.3% ST-elevation myocardial infarction STEMI and 53.7% non–ST-elevation ACS NSTE-ACS) enrolled in the ACS survey in Israel. Renal function, assessed using 5 formulas as proxies of creatinine clearance or estimated glomerular filtration rate (Cockcroft-Gault, modification of diet in renal disease MDRD, Chronic Kidney Disease Epidemiology Collaboration, Mayo quadratic, and inulin clearance based), varied in applying the different formulas. For both STEMI and NSTE-ACS patients, the Mayo formula yielded the highest mean value (88.9 ± 27.7 and 81.4 ± 29.2 mL/min per 1.73 m2 , respectively) and Chronic Kidney Disease Epidemiology Collaboration the lowest (73.0 ± 23.1 and 67.0 ± 24.1 mL/min per 1.73 m2 , respectively). Using multivariate analysis, worse renal function was independently associated with increased mortality risk by 30% to 40% for each decrement of 10 U of creatinine clearance or estimated glomerular filtration rate in STEMI patients and by 25% to 30% for NSTE-ACS patients, using all 5 formulas. The only formula that more accurately predicted 1-year mortality than the MDRD formula was the Mayo quadratic formula with a 1-year net reclassification index of 0.26 and 0.14 for STEMI and NSTE-ACS patients, respectively, after multivariable adjustment. Conclusion Worse renal function was an independent predictor for short- and long-term mortality using all 5 formulas in a broad spectrum of ACS patients, but only the Mayo quadratic formula had better accuracy in predicting mortality relative to the MDRD, suggesting that it may be the preferred prognosticator among ACS patients.
The link between thyroid dysfunction and cardiovascular disease is well established. Hypothyroidism has been significantly associated with increased risk of dyslipidemia, atherosclerosis and heart ...failure. However, little is known regarding its effect on patients undergoing percutaneous coronary intervention (PCI).
The aim of study was to examine the impact of concomitant hypothyroidism on mortality and major adverse cardiac event (MACE) in patients undergoing PCI.
The Rabin Medical Center PCI registry includes all consecutive patients who have undergone PCI between 2004 and 2020. We identified patients with prior diagnosis of hypothyroidism, and compared rates of mortality and MACE (comprising death, myocardial infarction, target vessel revascularization and/or coronary bypass surgery).
Among 28,274 patients, 1,922 (6.8%) were found to have hypothryoidism. These patients were older (70.3 ± 10.4 vs. 66.0 ± 11.8 y.o,
< 0.001) and more likely to be women (34.2% vs. 26.1%,
< 0.001). They had a higher prevalence of atrial fibrillation (10.8% vs. 7.7%,
< 0.001), chronic renal dysfunction (25.1% vs. 18.7%,
= 0.04) and dementia (2.9% vs. 1.8%,
= 0.004). PCI was performed on ACS setting in 52-54% of patients in both groups (
= 0.569). Unadjusted 5-year rates of all-cause mortality (26.9% vs. 20.3%,
< 0.001) and MACE (40.3% vs. 29.4%,
< 0.001) were higher for hypothyroid patients. A propensity match score was able to form 672 matched pairs of HT and control patients, showing similar results. Moreover, following multivariate analysis, TSH as a continuous parameter was associated with a higher risk of mortality and MACE (HR, 1.06 per additional 1 mIU/L; CI, 1.02-1.11;
< 0.001 and HR, 1.07; CI, 1.02-1.12;
< 0.001, respectively) at 5-year follow up.
In our study, hypothyroidism confers worse outcomes in patients undergoing PCI. Further research is needed to establish effective ways to mitigate this augmented risk.
The Valve-in-Valve (ViV) technique is an emerging alternative for the treatment of bioprosthetic structural valve deterioration (SVD) in the mitral position. We report on intermediate-term outcomes ...of patients with symptomatic SVD in the mitral position who were treated by transcatheter mitral valve-in-valve (TM-ViV) implantation during the years 2010-2019 in our center. Three main outcomes were examined during the follow-up period: NYHA functional class, TM-ViV hemodynamic data per echocardiography, and mortality. Our cohort consisted of 49 patients (mean age 77.4 ± 10.5 years, 65.3% female). The indications for TM-ViV were mainly for regurgitant pathology (77.6%). All 49 patients were treated with a balloon-expandable device. The procedure was performed
transapical access in 17 cases (34.7%) and transfemoral vein/trans-atrial septal puncture in 32 cases (65.3%). Mean follow-up was 4.4 ± 2.0 years. 98% and 91% of patients were in NYHA I/II at 1 and 5 years, respectively. Mitral regurgitation was ≥moderate in 86.3% of patients prior to the procedure and this decreased to 0% (
< 0.001) following the procedure and was maintained over 2 years follow-up. The mean trans-mitral valve gradients decreased from pre-procedural values of 10.1 ± 5.1 mmHg to 7.0 ± 2.4 mmHg at 1 month following the procedure (
= 0.03). Mortality at 1 year was 16% (95%, CI 5-26) and 35% (95%, CI 18-49) at 5 years. ViV in the mitral position offers an effective and durable treatment option for patients with SVD at high surgical risk.
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