Temporal Trends in Patient Characteristics and Clinical Outcomes of TAVR: Over a Decade of Practice.

Background/Objective: Transcatheter aortic valve replacement (TAVR) is indicated for severe aortic stenosis patients with a prohibitive surgical risk. However, its use has been expanding in recent years to include intermediate- and low-risk patients. Thus, registry data describing changes in patient characteristics and outcomes are needed. The aim of this study was to analyse the temporal changes in patient profiles and clinical outcomes of all-comer TAVR. Methods: Baseline characteristics and VARC-3 outcomes of 1632 consecutive patients undergoing TAVR between 2008 and 2021 were analysed. Results: The annual rate of TAVR increased from 30 procedures in 2008-2009 to 398 in 2020-2021. Over the follow-up period, patient age decreased from 85 ± 4 to 80 ± 6.8 (p < 0.001) and the STS score decreased from 5.9% to 2.8% (p < 0.001). Procedural characteristics significantly changed, representing a shift into a minimally invasive approach: adoption of local anaesthesia (none to 48%, p < 0.001) and preference of transfemoral access (74% in 2011-2012 vs. 94.5% in 2020-2021, p < 0.001). The rates of almost all procedural complications decreased, including major vascular and bleeding complications, acute kidney injury (AKI) and in-hospital heart failure. There was a striking decline in rates of complete atrioventricular block (CAVB) and the need for a permanent pacemaker (PPM). PPM rates, however, remain high (17.8%). Thirty-day and one-year mortality significantly declined to 1.8% and 8.3%, respectively. Multivariable analysis shows that AKI, bleeding and stroke are strong predictors of one-year mortality (p < 0.001). Conclusions: The TAVR procedure has changed dramatically during the last 14 years in terms of patient characteristics, procedural aspects and device maturity. These shifts have led to improved procedural safety, contributing to improved short- and long-term patient outcomes.

Cardiology department versus intensive care unit admission after successful uncomplicated transcatheter aortic valve replacement (TAVR).

BACKGROUND: Most patients after transcatheter aortic valve replacement (TAVR) are admitted directly to the cardiac intensive care unit (CICU) despite low complication rates. Reducing unnecessary CICU hospitalization reduces healthcare costs. This study aimed to compare the outcomes between patients admitted directly to the cardiology department (CD) and those admitted to CICU based on prespecified protocols. METHODS: Historical cohort study of all patients who underwent TAVR and were admitted directly to the CD according to a prespecified protocol (uncomplicated procedure, hemodynamically stable, without new conduction abnormalities) in 2017-2018, and the same number of patients meeting the same criteria who were admitted to the CICU in 2015-2016 before direct CD admission was initiated. Pacemaker implantation during the procedure was not considered a new conduction abnormality. In-hospital outcomes and 30-day post-discharge outcomes were compared. RESULTS: Overall, 260 patients (130 CICU + 130 CD) were included in the study. There was no in-hospital mortality in either group, and the post-procedure length of stay was shorter for patients admitted to CD (median and IQR: 2, 2-4 vs. 4, 3-5 days, p <0.001). There was no significant difference in 30-day emergency department visits between groups (CICU:13.9% vs. CD:16.2%, p = 0.602), rehospitalization rate (9.3%) was the same in both groups, and one patient from the CICU group died. Similar results were observed in multivariable analysis and after matching. CONCLUSION: Direct admission to the CD after TAVR, according to the proposed criteria, may be considered as a safe and less expensive alternative for stable patients after an uncomplicated TAVR procedure.

Transcatheter edge-to-edge repair in papillary muscle injury complicating acute myocardial infarction.

AIMS: Acute mitral regurgitation (MR) in the setting of myocardial infarction (MI) may be the result of papillary muscle rupture (PMR). This condition is associated with high morbidity and mortality. We aim to evaluate the feasibility of transcatheter edge-to-edge mitral valve repair (TEER) in this acute setting. METHODS AND RESULTS: We analysed data from the International Registry of MitraClip in Acute Mitral Regurgitation following acute Myocardial Infarction (IREMMI) of 30 centres in Europe, North America, and the middle east. We included patients with post-MI PMR treated with TEER as a salvage procedure, and we evaluated immediate and 30-day outcomes. Twenty-three patients were included in this analysis (9 patients suffered complete papillary muscle rupture, 9 partial and 5 chordal rupture). The patients' mean age was 68 ± 14 years. Patients were at high surgical risk with median EuroSCORE II 27% (IQR 16, 28) and 20 out of 23 (87% were in cardiogenic shock). All patients were treated with vasopressors, and 17 out of 23 patients required mechanical support. TEER procedure was performed on the median 6 days after the index MI date IQR (3, 11). Procedural success was achieved in 87% of patients. The grade of MR was significantly decreased after the procedure. MR reduction to 0 or 1 + was achieved in 13 patients (57%), to 2 + in 7 patients (30%), P < 0.01. V-Wave was reduced from 49 ± 8 mmHg to 26 ± 10 mmHg post-procedure, P < 0.01. Sixteen out of 23 patients (70%) were discharged from hospital and 5 of them required reintervention with surgical mitral valve replacement. No additional death at 1 year was documented. CONCLUSIONS: TEER is a feasible therapy in critically ill patients with PMR due to a recent MI. TEER may have a role as salvage treatment or bridge to surgery in this population.

Echocardiography vs hemodynamic assessment of diastolic dysfunction.

OBJECTIVES: Ostial CTOs can be challenging to revascularize. We aim to describe the outcomes of ostial chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: We examined the clinical and angiographic characteristics and procedural outcomes of 8788 CTO PCIs performed at 35 US and non-US centers between 2012 and 2022. In-hospital major adverse cardiac events (MACE) included death, myocardial infarction, urgent repeat target-vessel revascularization, tamponade requiring pericardiocentesis or surgery, and stroke. RESULTS: Ostial CTOs constituted 12% of all CTOs. Patients with ostial CTOs had higher J-CTO score (2.9 ± 1.2 vs 2.3 ± 1.3; P less than .01). Ostial CTO PCI had lower technical (82% vs. 86%; P less than .01) and procedural (81% vs. 85%; P less than .01) success rates compared with non-ostial CTO PCI. Ostial location was not independently associated with technical success (OR 1.03, CI 95% 0.83-1.29 P =.73). Ostial CTO PCI had a trend towards higher incidence of MACE (2.6% vs. 1.8%; P =.06), driven by higher incidence of in-hospital death (0.9% vs 0.3% P less than.01) and stroke (0.5% vs 0.1% P less than .01). Ostial lesions required more often use of the retrograde approach (30% vs 9%; P less than .01). Ostial CTO PCI required longer procedure time (149 [103,204] vs 110 [72,160] min; P less than .01) and higher air kerma radiation dose (2.3 [1.3, 3.6] vs 2.0 [1.1, 3.5] Gray; P less than .01). CONCLUSIONS: Ostial CTOs are associated with higher lesion complexity and lower technical and procedural success rates. CTO PCI of ostial lesions is associated with frequent need for retrograde crossing, higher incidence of death and stroke, longer procedure time and higher radiation dose.

Comparison of MANTA versus Perclose Prostyle large-bore vascular closure devices during transcatheter aortic valve implantation.

BACKGROUND: New vascular closure devices (VCD) are being introduced for achieving hemostasis after transcatheter aortic valve implantation (TAVI). However, no safety or efficacy data have been published compared to other contemporary VCD. AIM: To compare the safety and efficacy of suture-based Perclose Prostyle as compared to plug-based MANTA device. METHODS: A total of 408 consecutive TAVI patients from two high volume TAVI centers were included in the present study. Patients were grouped according to VCD: Prostyle versus MANTA. Propensity score matching (PSM) and multivariable analysis were utilized to compare clinical endpoints between the two groups. The primary endpoint was any vascular complication (VC) according to VARC-3 criteria. RESULTS: After PSM, a total of 264 patients were analyzed, of them 132 in each group. Overall baseline characteristics of the two groups were comparable. Primary end-point was similar between MANTA as compared to Prostyle (16.7% vs. 15.3% respectively, p = 0.888). The main driver for VC among MANTA group were minor vascular complications (15.2%). Conversely, minor and major VC contributed equally to the primary endpoint among Prostyle group (7.6%) (p = 0.013). No outcome predictors were identified in multivariate analysis. CONCLUSIONS: VCD for transfemoral TAVI using the new-generation Prostyle device or the MANTA device achieved comparable VARC-3 VC rates.

Transcatheter edge-to-edge mitral valve repair in patients with acute decompensated heart failure due to severe mitral regurgitation.

BACKGROUND: Transcatheter edge-to-edge mitral valve repair (TEER) has been established as a therapy for severe symptomatic mitral regurgitation (MR) in stable patients, and it has recently emerged as a reasonable option for acutely ill patients. The aim of this study was to evaluate the safety and efficacy of TEER in hospitalized patients with acute decompensated heart failure (ADHF) and severe MR that was deemed to play a major role in their deterioration. METHODS: We included 31 patients who underwent emergent TEER for MR ≥ 3+ from 2012 to 2022 at Sheba Medical Center. Outcomes included procedural safety, procedural success, all-cause mortality, heart failure readmission, and functional improvement. Outcomes were evaluated at 3 months and at 1 year. Data were obtained retrospectively by chart review. RESULTS: Implantation of a TEER device was achieved in 97% of patients, and reduction in MR severity of at least two grades and final MR ≤ 2+ at discharge was achieved in 74%. No intra-procedural mortality or life-threatening complications were noted. Mortality at 30 days was 23%. No excess mortality occurred beyond 6 months, with a total mortality of 41%. At 1 year all survivors had MR ≤ 2+, all were free of heart failure hospitalizations, and 88% were at New York Heart Association class ≤ II. CONCLUSIONS: Mitral valve TEER for patients with ADHF and significant MR is safe, feasible, and achieves substantial reduction in MR severity. Despite high early mortality, procedural success is associated with good long-term clinical outcomes for patients surviving longer than 6 months.

Evaluation of coronary disease among patients undergoing transcatheter aortic valve implantation: propensity score matching analysis.

BACKGROUND: Chronic coronary syndrome (CCS) is common among elderly patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI). Current guidelines recommend performance of percutaneous coronary intervention (PCI) of any > 70% proximal coronary lesions prior to TAVI. AIMS: To evaluate the outcomes of two diagnostic approaches for CCS clearance pre-TAVI and to determine the reduction in the need of invasive angiography (IA). METHODS: We investigated 2219 patients undergoing TAVI for severe aortic stenosis at two large centers with different pre-procedural strategies for CCS assessment: pre-TAVI computed tomography angiography (CTA) with selective invasive angiography according to CTA results or mandatory IA. We preformed propensity score matching analysis using a 1:1 ratio. The final study cohort included 870 matched patients. Peri-procedural complications were documented according to the VARC-2 criteria. Mortality rates were prospectively documented. RESULTS: Mean age of the study population was 82 ± 7, of whom 55% were female. Patients in the IA group had significantly higher rates of pre-TAVI PCI compared to the CTA group (39% vs. 22%, p < 0.001). Following TAVI, peri-procedural myocardial infarction (MI) rates were similar between the two groups (0.3% vs. 0.7%, p value = 0.41), but spontaneous MI were significantly lower among the IA group (0% vs. 1.3%, p value = 0.03). Kaplan-Meier's survival analysis found that the cumulative probability of 1-year morality was similar between the two groups (p value log rank = 0.65). Cox regression analysis did not find association between CCS clearance strategy and outcome. CONCLUSIONS: In elderly patients, CTA-driven approach for CCS evaluation pre-TAVI is a valid strategy with similar outcome as compared to invasive approach. CTA strategy significantly reduces invasive procedures rates without compromising patient's outcome.

Pseudo-discordance mimicking low-flow low-gradient aortic stenosis in transcatheter aortic valve replacement patients with severe symptomatic aortic stenosis.

BACKGROUND: While the combination of a small aortic valve area (AVA) and low mean gradient is frequently labeled 'low-flow low-gradient aortic stenosis (AS)', there are two potential causes for this finding: underestimation of mean gradient and underestimation of AVA. METHODS: In order to investigate the prevalence and causes of discordant echocardiographic findings in symptomatic patients with AS and normal left ventricular (LV) function, we evaluated 72 symptomatic patients with AS and normal LV function by comparing Doppler, invasive, computed tomography (CT) LV outflow tract (LVOT) area, and calcium score (CaSc). RESULTS: Thirty-six patients had discordant echocardiographic findings (mean gradient < 40 mmHg, AVA ≤ 1 cm²). Of those, 19 had discordant invasive measurements (true discordant [TD]) and 17 concordant (false discordant [FD]): In 12 of the FD the mean gradient was > 30 mmHg; technical pitfalls were found in 10 patients (no reliable right parasternal Doppler in 6). LVOT area by echocardiography or CT could not differentiate between concordants and discordants nor between TD and FD (p = NS). CaSc was similar in concordants and FD (p = 0.3), and it was higher in true concordants than in TD (p = 0.005). CaSc positive predictive value for the correct diagnosis of severe AS was 95% for concordants and 93% for discordants. CONCLUSIONS: Discordant echocardiographic findings are commonly found in patients with symptomatic AS. Underestimation of the true mean gradient due to technical difficulties is an important cause of these discrepant findings. LVOT area by echocardiography or CT cannot differentiate between TD and FD. In the absence of a reliable and compete multi-window Doppler evaluation, patients should undergo CaSc assessment.

Left atrial size predicts long-term outcome after balloon mitral valvuloplasty.

BACKGROUND: The treatment of choice for severe rheumatic mitral stenosis is balloon mitral valvuloplasty (BMV). Numerous predictors of immediate and long-term procedural success have been described. The aims of this study were to describe our experience with BMV over the last decade and to evaluate predictors of long-term event-free survival. METHODS: Medical records were retrospectively analyzed of patients who underwent BMV between 2009 and 2021. The primary outcome was a composite endpoint of all-cause mortality, mitral valve replacement (MVR), and repeat BMV. Long-term event-free survival was estimated using Kaplan-Meier curves. Logistic regression was used to create a multivariate model to assess pre-procedural predictors of the primary outcome. RESULTS: A total of 96 patients underwent BMV during the study period. The primary outcome occurred in 36 patients during 12-year follow-up: one (1%) patient underwent re-BMV, 28 (29%) underwent MVR, and eight (8%) died. Overall, event-free survival was 62% at 12 years. On multivariate analysis, pre-procedural left atrial volume index (LAVI) > 80 mL/m2 had a significant independent influence on event-free survival, as did previous mitral valve procedure and systolic pulmonary arterial pressure above 50 mmHg. CONCLUSIONS: Despite being a relatively low-volume center, excellent short and long-term results were demonstrated, with event-free survival rates consistent with previous studies from high-volume centers. LAVI independently predicted long-term event-free survival.

Early Invasive Strategy and Outcome of Non-ST-Segment Elevation Myocardial Infarction Patients With Chronic Kidney Disease.

BACKGROUND: Current guidelines suggest that an early invasive strategy should be considered for the treatment of non-ST-segment elevation myocardial infarction (NSTEMI). Although chronic kidney disease (CKD) is common among NSTEMI patients, these patients are under-represented in clinical trials, and data regarding their management are limited. OBJECTIVES: The authors sought to evaluate the association between early invasive strategy and long-term survival among patients with NSTEMI and CKD. METHODS: This was a retrospective analysis of 7,107 consecutive NSTEMI patients between 2008 and 2021. Patients were dichotomized into early (≤24 hours) and delayed invasive groups and stratified by kidney function. Inverse probability treatment weighting was used to adjust for differences in baseline characteristics. The primary outcome was all-cause mortality. RESULTS: The final study population comprised 3,529 invasively treated patients with a median age of 66 years (IQR: 58-74 years), 1,837 (52%) of whom were treated early. There were 483 (14%) patients with at least moderate CKD (estimated glomerular filtration rate [eGFR] <45 mL/min/1.73 m2). During a median follow-up of 4 years (IQR: 2-6 years), 527 (15%) patients died. After inverse probability treatment weighting, an early invasive strategy was associated with a significant 30% lower mortality compared with a delayed strategy (HR: 0.7; 95% CI: 0.56-0.85). The association between early invasive strategy and mortality was modified by eGFR (Pinteraction < 0.001) and declined with lower renal function, with no difference in mortality among patients with eGFR <45 mL/min/1.73 m2 (HR: 0.89; 95% CI: 0.64-1.24). CONCLUSIONS: Among NSTEMI patients, the association of early invasive strategy with long-term survival is modified by CKD and was not observed in patients with eGFR <45 mL/min/1.73 m2.

Management and outcome of patients with non-ST elevation myocardial infarction and intercurrent non-coronary precipitating events.

AIMS: To evaluate the effect of an intercurrent non-coronary illness on the management and outcome of patients with non-ST-segment elevation myocardial infarction (NSTEMI). METHODS AND RESULTS: Consecutive hospitalized patients with a primary diagnosis of NSTEMI between August 2008 and December 2019 at Sheba Medical Center. All patients' records were reviewed for the presence of a non-coronary precipitating event (NCPE): a major intercurrent acute non-coronary illness or condition, either cardiac or non-cardiac. The primary outcome was all-cause mortality. Cox regression with interaction analysis was applied. Final study population comprised 6491 patients, of whom 2621 (40%) had NCPEs. Patients with NCPEs were older (77 vs. 69 years) and more likely to have comorbidities. The most prevalent event was infection (35%, n = 922). During a median follow-up of 30 months, 2529 patients died. Patients with NCPEs were 43% more likely to die during follow-up in a multivariable model (95% CI: 1.31-1.55). Invasive strategy was associated with a 55% lower mortality among patients without NCPE and only 44% among patients with NCPE (P for interaction < 0.001). Dual antiplatelet therapy (DAPT) was associated with a 20% lower mortality in patients without NCEP and a non-significant mortality difference among patients with NCPE (P for interaction = 0.014). Sub-analysis by the specific NCPE showed the highest mortality risk among patients with infectious precipitant. The lower mortality associated with invasive strategy was not observed in this subgroup. CONCLUSION: Among NSTEMI patients, the presence of an NCPE is associated with poor survival and modifies the effect of management strategies.

Procedural and long-term outcome among patients undergoing expedited trans-catheter aortic valve replacement.

OBJECTIVE: Patients with rapidly deteriorating clinical status due to severe aortic stenosis are often referred for expedited transcatheter aortic valve replacement (TAVR). Data regarding the outcome of such interventions is limited. We aimed to evaluate the outcome of patients undergoing expedited TAVR. DESIGN AND SETTING: Data were derived from the Israeli Multicenter Registry. SUBJECTS: Subjects were divided into two groups based on procedure urgency: patients who were electively hospitalized for the procedure (N = 3140) and those who had an expedited TAVR (N = 142). Procedural and periprocedural complication rates were significantly higher among patients with an expedited indication for TAVR compared to those having an elective procedure: valve malposition 4.6% versus 0.6% (p < 0.001), procedural cardiopulmonary resuscitation 4.3% versus 1.0% (p = 0.007), postprocedure myocardial infarction 2.0% versus 0.4% (p = 0.002), and stage 3 acute kidney injury 3.0% versus 1.1%, (p < 0.001). Patients with expedited indication for TAVR had significantly higher in hospital mortality (5.6% vs. 1.4%, p = 0.003). Kaplan-Meier's survival analysis showed that patients undergoing expedited TAVR had higher 3-year mortality rates compared to patients undergoing an elective TAVR procedure (p < 0.001). Multivariate analysis found that patients with expedited indication had fourfolds increased risk of in-hospital mortality (odds ratio: 4.07, p = 0.001), and nearly twofolds increased risk of mortality at 3-year (hazard ratio: 1.69, p = 0.001) compared to those having an elective procedure. CONCLUSION: Patients with expedited indications for TAVR suffer from poor short- and long-term outcomes. It is important to characterize and identify these patients before the deterioration to perform TAVR in a fast-track pathway to minimize their procedural risk.

Invasive Management in Older Adults (≥80 Years) With Non-ST Elevation Myocardial Infarction.

OBJECTIVE: To evaluate the association of invasive management (coronary angiogram) with all-cause mortality among older adult (≥80 years of age) patients presenting with non-ST elevation myocardial infarction (NSTEMI) by frailty status. PATIENTS AND METHODS: This study used a retrospective cohort of consecutive older adult patients who were hospitalized with NSTEMI as their primary clinical diagnosis between August 1, 2008, and December 31, 2019. Cox regression models were applied with stratification by frailty status (low, medium, and high). Extensive sensitivity analyses were conducted including propensity score matching and inverse probability treatment weighting models. RESULTS: The study population included 2317 patients with median age of 86 years (IQR, 83-90 years) of whom 1243 (53.6%) were men. Patients who were managed invasively (n=581 [25%]) were less likely to be frail (7% vs 44%, P<.001). During the follow-up (median, 19 months, IQR, 4-41 months), 1599 (69%) patients died. In a multivariable Cox model, invasive approach was associated with adjusted hazard ratio (HR) of 0.61 (95% CI, 0.53 to 0.71) for the risk of death. The benefit of invasive approach was consistent among low, medium, and high frailty subgroups with adjusted HRs of 0.74 (95% CI, 0.58 to 0.93), 0.65 (95% CI, 0.50 to 0.85), and 0.52 (95% CI, 0.34 to 0.78), respectively (P for interaction = 0.48). Results were consistent with propensity score matching and inverse probability treatment weighting analyses (HR, 0.6; 95% CI, 0.50 to 0.71 and HR, 0.67; 95% CI, 0.55 to 0.82, respectively). Sensitivity analysis addressing potential immortal time bias and residual confounding yielded similar results. CONCLUSION: Invasive approach is associated with improved survival among older adults with NSTEMI irrespective of frailty status.

The Association of Severe Tricuspid Regurgitation with Poor Survival Is Modified by Right Ventricular Pressure and Function: Insights from SHEBAHEART Big Data.

BACKGROUND: Contemporary data on the independent association of severe tricuspid regurgitation (TR) with excess mortality are needed. The aims of this study were to describe contemporary outcomes of patients with severe TR and to identify outcome modifiers. METHODS: Consecutive echocardiographic reports linked to clinical data from the largest medical center in Israel (2007-2019) were reviewed. The primary outcome was all-cause mortality. Cox regression and propensity score matching models were applied. RESULTS: The final cohort included 97,096 patients. Mild, moderate, and severe TR was documented in 27,147 (28%), 2,844 (3%) and 1,805 (2%) patients, respectively. During a median follow-up period of 5 years (interquartile range, 2-8 years), 22,170 patients (23%) died. Kaplan-Meier survival analysis demonstrated an increased risk for death with an increasing degree of TR (log-rank P < .001). Propensity score matching of 1,265 patients with severe TR and matched control subjects showed that compared with those with nonsevere TR, patients with severe TR were 17% more likely to die (95% CI, 1.05-1.29; P = .003). The association of severe TR with survival was dependent on estimated right ventricular (RV) pressure, with a more pronounced effect among patients with estimated systolic pressure ≤ 40 mm Hg (hazard ratio, 2.12 vs 1.04; P for interaction < .001). A landmark subanalysis of 17,967 patients demonstrated that RV function deterioration on follow-up echocardiography modified the association of severe TR with survival. It was more significant among patients with preserved and stable RV function (P for interaction = .035). CONCLUSIONS: The outcome of severe TR is modified by RV pressure and function. Once RV function deteriorates, differences in the outcomes of patients with and without severe TR are less pronounced.

Local Anesthesia versus Conscious Sedation among Patients Undergoing Transcatheter Aortic Valve Implantation-A Propensity Score Analysis.

BACKGROUND: Conscious sedation (CS) has been used successfully to treat patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) and as such is considered the standard anesthesia method. The local anesthesia (LA) only approach may be feasible and safe thanks to improvements in operators' experience. OBJECTIVE: To evaluate differences between LA only versus CS approaches on short- and long-term outcomes among patients undergoing TAVI. METHODS: We performed a propensity score analysis on 1096 patients undergoing TAVI for severe AS. Two hundred and seventy-four patients in the LA group were matched in a ratio of 1:3 with 822 patients in the CS group. The primary outcome was a 1-year mortality rate. Secondary outcomes included procedural and peri-procedural complication rates and in-hospital mortality. RESULTS: Patients in the CS group had significantly higher rates of grade 2-3 acute kidney injury and were more likely to have had new left bundle branch block and high-degree atrioventricular block. Patients who underwent TAVI under CS had significantly higher in-hospital and 1-year mortality rates compared to LA (1.6% vs. 0.0% p-value = 0.036 and 8.5% vs. 3.3% p-value = 0.004, respectively). Kaplan-Meier's survival analysis showed that the cumulative probability of 1-year mortality was significantly higher among subjects undergoing CS compared to patients LA (p-value log-rank = 0.024). Regression analysis indicated that patients undergoing CS were twice more likely to die of at 1-year when compared to patients under LA (HR 2.18, 95%CI 1.09-4.36, p-value = 0.028). CONCLUSIONS: As compared to CS, the LA-only approach is associated with lower rates of peri-procedural complications and 1-year mortality rates.

Peripheral Arterial Disease in Patients With Acute Coronary Syndrome: Results From a Large Real-World Registry.

BACKGROUND: Limited data exist regarding the significance of peripheral arterial disease (PAD) in patients with acute coronary syndrome (ACS). METHODS: We evaluated 16,922 consecutive ACS patients who were prospectively included in a national ACS registry. The co-primary endpoint included 30 days major adverse cardiovascular event (MACE) (re-infarction, stroke, and/or cardiovascular death) and 1-year mortality. RESULTS: PAD patients were older (70±11 vs 63±13; p<0.01), male predominance (80% vs 77%; p=0.01), and more likely to sustain prior cardiovascular events. PAD patients were less likely to undergo coronary angiography (69% vs 83%; p<0.001) and revascularisation (80% vs 86%; p<0.001). Patients with PAD were more likely to sustain 30-day MACE (22% vs 14%; p<0.001) and mortality (10% vs 4.4%; p<0.001), as well as re-hospitalisation (23% vs 19%; p=0.001). After adjusting for potential confounders, PAD remained an independent predictor of 30-day MACE (odds ratio [OR], 1.6 [95% confidence interval (CI), 1.24-2.06]). Patients with compared to those without PAD had 2.5 times higher 1-year mortality rate (22% vs 9%; p<0.001). Co-existence of PAD remained an independent predictor of 1-year mortality after adjustment for potential confounders by multivariable regression analysis (OR, 1.62; 95% CI, 1.4-1.9). PAD was associated with a significant higher 1-year mortality rate across numerous sub-groups of patients including type of myocardial infarction (ST-elevation myocardial infarction vs non-ST-elevation myocardial infarction), and whether the patient underwent revascularisation. CONCLUSIONS: Acute coronary syndrome with concomitant PAD represents a high-risk subgroup that warrants special attention and a more tailored approach.

Hemodynamic Changes After Left Ventricular Assist Device Implantation Among Heart Failure Patients With and Without Elevated Pulmonary Vascular Resistance.

Background: Left ventricular assist devices (LVADs) may reverse elevated pulmonary vascular resistance (PVR) which is associated with worse prognosis in heart failure (HF) patients. We aim to describe the temporal changes in hemodynamic parameters before and after LVAD implantation among patients with or without elevated PVR. Methods: HF patients who received continuous-flow LVAD (HeartMate 2&3) at a tertiary medical center and underwent right heart catheterization with PVR reversibility study before and after LVAD surgery. Patients were divided into 3 groups: normal PVR (<4WU); reversible PVR (initial PVR ≥4WU with positive reversibility); and non-reversible (persistent PVR ≥4WU). Results: Overall, 85 LVAD patients with a mean age of 58 years (IQR 49-64), 65 patients (76%) were male; 60 patients had normal PVR, 20 patients with reversible and 5 patients with non-reversible PVR pre-LVAD. All patients with elevated PVR (≥4WU) had higher pulmonary pressures (PP) and increased trans-pulmonary gradient (TPG) compared to patients with normal PVR (p < 0.05). Patients with non-reversible PVR were more likely to have a significantly lower baseline cardiac output (CO) compared to all other groups (p ≤ 0.02). Hemodynamic parameters and PVR post LVAD were similar in all study groups. Patients with baseline elevated PVR (reversible and non-reversible) demonstrated a significant improvement in PP and TPG compared to patients with normal baseline PVR (p ≤ 0.05). The improvement in CO and PVR post-LVAD in the non-reversible PVR group was significantly greater compared to all other groups (p < 0.01). There were no significant differences between study groups in post LVAD and post heart transplantation course. Conclusion: Hemodynamic parameters improved after LVAD implantation, regardless of baseline PVR and reversibility, and enabled heart transplantation in patients who were ineligible due to non-reversible elevated PVR. Our findings suggest that mitigation of elevated non-reversible PVR is related to reduction in PP and increase in CO.

Pacing burden and clinical outcomes after transcatheter aortic valve replacement-A real-world registry report.

INTRODUCTION: Conflicting data exist on the prognostic significance of permanent pacemaker (PPM) implantation after transcatheter aortic valve replacement (TAVR). OBJECTIVE: The purpose of this study was to evaluate whether PPM implantation after TAVR is associated with adverse outcomes. METHODS: A retrospective analysis of a cohort comprised patients enrolled in a prospective registry between 2008 and 2019. Participants were allocated into 3 groups: patients without a prior pacemaker (n = 930 [75%]), those with previous pacemaker implantation (n = 118 [10%]), and those with pacemaker implantation after TAVR (n = 191 [15%]). The primary outcome included death and heart failure hospitalizations at 1 year. Secondary outcomes included death and heart failure hospitalizations stratified by pacing burden. RESULTS: A total of 1239 patients underwent TAVR with a median follow-up period of 2.3 years (interquartile range 1-4 years). Patients with previous and new pacemaker implantation were older (84 [80-88], 84 [80-88], and 82 [78-86] years; P = .009) and had lower baseline left ventricular ejection fraction (50% ± 15%, 55% ± 12%, and 56% ± 12%; P < .001). Patients who underwent new pacemaker implantation had higher combined outcome of death and heart failure hospitalizations (21%,12%, and 14%; P = .01). New pacemaker implantation was associated with almost twice the risk of 1-year mortality (odds ratio 1.85; 95% confidence interval 1.13-3.02; P = .014). Pacing burden, however, was not associated with the primary outcome. Furthermore, no significant difference was observed at long-term follow-up (cumulative probability to develop the primary end point at 3 years was 57% ± 2% [without PPM], 57% ± 6% [prior PPM], 54% ± 4% [new PPM]; P = .52). CONCLUSION: Pacemaker implantation after TAVR is associated with higher 1-year adverse outcome, but this attenuates over time, suggesting that competing factors may play a role. Interestingly, pacing burden is not associated with adverse clinical course.

Diastolic Plateau - Invasive Hemodynamic Marker of Adverse Outcome Among Left Ventricular Assist Device Patients.

Background: Diastolic plateau is an invasive hemodynamic marker of impaired right ventricular (RV) diastolic filling. The purpose of the current analysis was to evaluate the prognostic importance of this sign in left ventricular assist device (LVAD) patients. Methods: The analysis included all LVAD patients who received continuous-flow LVAD (HeartMate 3) at the Sheba medical center and underwent right heart catheterization (RHC) during follow up post-LVAD surgery. Patients were dichotomized into 2 mutually exclusive groups based on a plateau duration cutoff of 55% of diastole. The primary end point of the current analysis was the composite of death, heart transplantation, or increase in diuretic dosage in a 12-month follow-up period post-RHC. Results: Study cohort included 59 LVAD patients with a mean age of 57 (IQR 54-66) of whom 48 (81%) were males. RHC was performed at 303 ± 36 days after LVAD surgery. Patients with and without diastolic plateau had similar clinical, echocardiographic, and hemodynamic parameters. Kaplan-Meier survival analysis showed that the cumulative probability of event at 1 year was 65 ± 49% vs. 21 ± 42% for primary outcomes among patients with and without diastolic plateau (p Log rank < 0.05 for both). A multivariate model with adjustment for age, INTERMACS score and ischemic cardiomyopathy consistently showed that patients with diastolic plateau were 4 times more likely to meet the study composite end point (HR = 4.35, 95% CI 1.75-10.83, p = 0.002). Conclusion: Diastolic plateau during RHC is a marker of adverse outcome among LVAD patients.

The Impact of Novel Anti-Diabetic Medications on CV Outcomes: A New Therapeutic Horizon for Diabetic and Non-Diabetic Cardiac Patients.

It is estimated that in the past two decades the number of patients diagnosed with diabetes mellites (DM) has doubled. Despite significant progress in the treatment of cardiovascular disease (CVD), including novel anti-platelet agents, effective lipid-lowering medications, and advanced revascularization techniques, patients with DM still are least twice as likely to die of cardiovascular causes compared with their non-diabetic counterparts, and current guidelines define patients with DM at the highest risk for atherosclerotic cardiovascular disease and major adverse cardiovascular events (MACE). Over the last few years, there has been a breakthrough in anti-diabetic therapeutics, as two novel anti-diabetic classes have demonstrated cardiovascular benefit with consistently reduced MACE, and for some agents, also improvement in heart failure status as well as reduced cardiovascular and all-cause mortality. These include the sodium-glucose cotransporter-2 inhibitors and the glucagon-like peptide-1 receptor agonists. The benefits of these medications are thought to be derived not only from their anti-diabetic effect but also from additional mechanisms. The purpose of this review is to provide the everyday clinician a detailed review of the various agents within each class with regard to their specific characteristics and the effects on MACE and cardiovascular outcomes.