Interventricular septal thickness on cardiac computed tomography as a novel risk factor for conduction disturbances in patients undergoing transcatheter aortic valve replacement.

AIMS: We examined whether thickness of the basal muscular interventricular septum (IVS), as measured by pre-procedural computed tomography (CT), could be used to identify the risk of conduction disturbances following transcatheter aortic valve replacement (TAVR). The IVS is a pivotal region of the electrical conduction system of the heart where the atrioventricular conduction axis is located. METHODS AND RESULTS: Included were 78 patients with severe aortic stenosis who underwent CT imaging prior to TAVR. The thickness of muscular IVS was measured in the coronal view, in systolic phases, at 1, 2, 5, and 10 mm below the membranous septum (MS). The primary endpoint was a composite of conduction disturbance following TAVR. Conduction disturbances occurred in 24 out of 78 patients (30.8%). Those with conduction disturbances were significantly more likely to have a thinner IVS than those without conduction disturbances at every measured IVS level (2.98 ± 0.52 mm vs. 3.38 ± 0.52 mm, 4.10 ± 1.02 mm vs. 4.65 ± 0.78 mm, 6.11 ± 1.12 mm vs. 6.88 ± 1.03 mm, and 9.72 ± 1.95 mm vs. 10.70 ± 1.55 mm for 1, 2, 5 and 10 mm below MS, respectively, P < 0.05 for all). Multivariable logistic regression analysis showed that pre-procedural IVS thickness (<4 mm at 2 mm below the MS) was a significant independent predictor of post-procedural conduction disturbance (adjOR 7.387, 95% CI: 2.003-27.244, P = 0.003). CONCLUSION: Pre-procedural CT assessment of basal IVS thickness is a novel predictive marker for the risk of conduction disturbances following TAVR. The IVS thickness potentially acts as an anatomical barrier protecting the underlying conduction system from mechanical compression during TAVR.

Treatment of late paravalvular regurgitation after transcatheter aortic valve implantation: prognostic implications.

AIMS: Paravalvular regurgitation (PVR) after transcatheter aortic valve implantation (TAVI) is associated with increased morbidity and mortality. The effect of transcatheter interventions to treat PVR after the index TAVI was investigated. METHODS AND RESULTS: A registry of consecutive patients who underwent transcatheter intervention for ≥ moderate PVR after the index TAVI at 22 centers. The principal outcomes were residual aortic regurgitation (AR) and mortality at 1 year after PVR treatment. A total of 201 patients were identified: 87 (43%) underwent redo-TAVI, 79 (39%) plug closure, and 35 (18%) balloon valvuloplasty. Median TAVI-to-re-intervention time was 207 (35; 765) days. The failed valve was self-expanding in 129 (63.9%) patients. The most frequent devices utilized were a Sapien 3 valve for redo-TAVI (55, 64%), an AVP II as plug (33, 42%), and a True balloon for valvuloplasty (20, 56%). At 30 days, AR ≥ moderate persisted in 33 (17.4%) patients: 8 (9.9%) after redo-TAVI, 18 (25.9%) after plug, and 7 (21.9%) after valvuloplasty (P = 0.036). Overall mortality was 10 (5.0%) at 30 days and 29 (14.4%) at 1 year: 0, 8 (10.1%), and 2 (5.7%) at 30 days (P = 0.010) and 11 (12.6%), 14 (17.7%), and 4 (11.4%) at 1 year (P = 0.418), after redo-TAVI, plug, and valvuloplasty, respectively. Regardless of treatment strategy, patients in whom AR was reduced to ≤ mild had lower mortality at 1 year compared with those with AR persisting ≥ moderate [11 (8.0%) vs. 6 (21.4%); P = 0.007]. CONCLUSION: This study describes the efficacy of transcatheter treatments for PVR after TAVI. Patients in whom PVR was successfully reduced had better prognosis. The selection of patients and the optimal PVR treatment modality require further investigation.

Transcatheter Mitral Valve Replacement After Surgical Repair or Replacement: Comprehensive Midterm Evaluation of Valve-in-Valve and Valve-in-Ring Implantation From the VIVID Registry.

BACKGROUND: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining midterm outcomes after mitral ViV and ViR. METHODS: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ≥10 mm Hg and significant residual mitral regurgitation (MR) as ≥ moderate. RESULTS: A total of 1079 patients (857 ViV, 222 ViR; mean age 73.5±12.5 years; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days (interquartile range, 76-996); median echocardiographic follow-up for patients that survived 1 year was 772.5 days (interquartile range, 510-1211.75). Four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR (P<0.001). Mean gradient across the mitral valve postprocedure was 5.7±2.8 mm Hg (≥5 mm Hg; 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients (P=0.09). Significant residual MR was more common in ViR patients (16.6% versus 3.1%; P<0.001) and was associated with lower survival at 4 years (35.1% versus 61.6%; P=0.02). The rates of Mitral Valve Academic Research Consortium-defined device success were low for both procedures (39.4% total; 32.0% ViR versus 41.3% ViV; P=0.01), mostly related to having postprocedural mean gradient ≥5 mm Hg. Correlates for residual MS were smaller true internal diameter, younger age, and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (subhazard ratio, 4.67; 95% CI, 1.74-12.56; P=0.002) and significant residual MR (subhazard ratio, 7.88; 95% CI, 2.88-21.53; P<0.001) were both independently associated with repeat mitral valve replacement. CONCLUSIONS: Significant residual MS and/or MR were not infrequent after mitral ViV and ViR procedures and were both associated with a need for repeat valve replacement. Strategies to improve postprocedural hemodynamics in mitral ViV and ViR should be further explored.

Temporary Trends in Fever following Transcatheter Aortic Valve Implantation.

OBJECTIVES: Fever following transcatheter aortic valve implantation (TAVI) is a common phenomenon, attributed mostly to inflammatory response which may impact outcome. Systemic inflammatory response may be triggered by multiple factors, most associated with the TAVI procedure itself. However, there are no data regarding the incidence of fever following TAVI in contemporary era with newer generation devices. Our primary objective was to measure temporal trends in fever incidence and features following TAVI. METHODS: We analyzed a retrospective cohort of 802 consecutive patients who underwent TAVI at our institution between November 2008 and February 2018. We identified and characterized all patients who developed fever (>38.0°C from any cause) within the first 72 h following the procedure and analyzed incidence and characteristics stratified into 3 time frames: 2008-2014, 2014-2016, and 2016-2018. RESULTS: Following TAVI, 190 (23.7%) patients developed fever (mean age 82.3 ± 5.2 years, 64.2% female). An infectious etiology was evident in only 32.1% of cases. The frequency decreased gradually and significantly across timeframes (32.8, 23.6, and 14.5%, respectively, p < 0.001). In a multivariate regression analysis, 1st generation CoreValve (HR 1.91; CI 95% 1.2-3.04, p = 0.006) was found to be associated with higher incidence of fever in addition to female gender, vascular complications, transfemoral access, and reduced GFR. CONCLUSIONS: Fever incidence post TAVI decreased significantly throughout the last decade. The higher rate of fever in the early years of TAVI was likely associated with first-generation devices, vascular complications, and reduced GFR.

Temporal trends in short and long-term outcomes after percutaneous coronary interventions among cancer patients.

While mortality of acute coronary syndrome (ACS) is known to have steadily decline over the last decades, data are lacking regarding the complex sub-population of patients with both coronary artery disease and cancer. A large single-center percutaneous coronary intervention (PCI) registry was used to retrieve patients who had a known diagnosis of malignancy during PCI. Patients were divided into two groups according to the period in which PCI was performed (period 1: 2006-2011, period 2: 2012-2017). Cox regression hazard models were implemented to compare primary endpoint, defined as the composite outcomes of major adverse cardiac events (MACE) (which include cardiovascular death, myocardial infarction or target vessel revascularization) and secondary endpoint of all-cause mortality, between the two time periods. A total of 3286 patients were included, 1819 (55%) had undergone PCI in period 1, and 1467 (45%) in period 2. Both short- and long-term MACE and overall mortality were significantly lower in patients who underwent PCI at the latter period (2.3% vs. 4.3%, p < 0.001 and 1.1% vs. 3.2%, p < 0.001 after 30 days and 24% vs. 30%, p < 0.001 and 12% vs. 22%, p < 0.001 after 2 years, respectively). However, in a multivariate analysis, going through PCI in the latter period was still associated with lower rates of overall mortality (HR 0.708, 95% confidence interval [CI] 0.53-0.93, p = 0.014) but there was no significant difference in MACE (HR 0.83, 95% CI 0.75-1.42, p = 0.16). Patients with cancer undergoing PCI during our most contemporary period had an improved overall survival, but no significant differences were observed in the composite cardiovascular endpoints, compared to an earlier PCI period. The management of coronary patients with cancer disease remains challenging.

The initial U.S. experience with the Tempo active fixation temporary pacing lead in structural heart interventions.

OBJECTIVES: This multicenter retrospective study of the initial U.S. experience evaluated the safety and efficacy of temporary cardiac pacing with the Tempo® Temporary Pacing Lead. BACKGROUND: Despite increasing use of temporary cardiac pacing with the rapid growth of structural heart procedures, temporary pacing leads have not significantly improved. The Tempo lead is a new temporary pacing lead with a soft tip intended to minimize the risk of perforation and a novel active fixation mechanism designed to enhance lead stability. METHODS: Data from 269 consecutive structural heart procedures were collected. Outcomes included device safety (absence of clinically significant cardiac perforation, new pericardial effusion, or sustained ventricular arrhythmia) and efficacy (clinically acceptable pacing thresholds with successful pace capture throughout the index procedure). Postprocedure practices and sustained lead performance were also analyzed. RESULTS: The Tempo lead was successfully positioned in the right ventricle and achieved pacing in 264 of 269 patients (98.1%). Two patients (0.8%) experienced loss of pace capture. Procedural mean pace capture threshold (PCT) was 0.7 ± 0.8 mA. There were no clinically significant perforations, pericardial effusions, or sustained device-related arrhythmias. The Tempo lead was left in place postprocedure in 189 patients (71.6%) for mean duration of 43.3 ± 0.7 hr (range 2.5-221.3 hr) with final PCT of 0.84 ± 1.04 mA (n = 80). Of these patients, 84.1% mobilized out of bed with no lead dislodgment. CONCLUSION: The Tempo lead is safe and effective for temporary cardiac pacing for structural heart procedures, provides stable peri and postprocedural pacing and allows mobilization of patients who require temporary pacing leads.

Coronary Stents in Diabetic Patients: State of the Knowledge.

PURPOSE OF REVIEW: This review article aims to summarize the findings of the most relevant research that compared the use of paclitaxel vs. "limus" based drug eluting stent (DES) in diabetic patients and to define the current state of knowledge with new stent technologies in this patient population. RECENT FINDINGS: Since drug eluting stents (DES) were introduced, it has been of great interest to establish whether paclitaxel or sirolimus eluting stents have the same safety and efficacy features for patients with coronary artery disease. The answer to this question is particularly relevant for diabetic patients. Several randomized trials, registry-based studies, and meta-analyses have assessed the performance of these different DES in diabetic patients. The most recently published data favors limus over paclitaxel DES in diabetic patients, but most of these studies compared first vs. second generation DES with the inherent caveats of comparing different platforms, alloys, and drug delivery vehicles. In this literature review, we found that there is robust evidence favoring the use of DES over bare metal stents in diabetic patients with coronary artery disease. We also found that the current state of knowledge is that the everolimus eluting stents have better safety and efficacy than paclitaxel eluting stents in diabetic patients and hence should be the preferred choice. New revascularization strategies including bio-absorbable scaffolds, polymer free stents, and bio-degradable polymers are being studied in diabetic patients with encouraging results.

Platelet reactivity in patients undergoing transcatheter aortic valve implantation.

Thromboembolic events, primarily stroke, might complicate transcatheter aortic-valve implantation (TAVI) procedures in 3-5 % of cases. Thus, it is common to administer aspirin and clopidogrel pharmacotherapy for 3-6 months following TAVI in order to prevent those events. The biologic response to the dual anti platelet treatment (DAPT) is heterogeneous, e.g. low response, known as high on treatment platelet reactivity (HTPR) may be associated with adverse thromboembolic events. Little is known about the prevalence of HTPR among patients undergoing TAVI. To assess the variability in response and rates of residual platelet reactivity in patients undergoing TAVI. We examined platelet reactivity in response to clopidogrel and aspirin in 40 consecutive patients (mean age 81.7 ± 6.5 years, 66.7 % women) who underwent successful TAVI using the VerifyNow P2Y12 assay and the multiple electrode aggregometry assay (Multiplate analyzer) in response to adenosine diphosphate and arachidonic acid respectively, at different time points before and following TAVI. Before TAVI, the majority of patients were on antiplatelet therapy (68.5 % aspirin, 12.5 % clopidogrel, 12.5 % DAPT). Following the procedure all patients were on DAPT or clopidogrel and warfarin. Among analyzed patients, 41 % had HTPR for clopidogrel and 12.5 % for aspirin at baseline, which did not significantly change 1-month following the procedure (p = 0.81 and p  = 0.33, respectively). In conclusion, patients undergoing TAVI for severe aortic stenosis and treated with DAPT have high rates of residual platelet reactivity during the peri-procedural period and up to 1-month thereafter. These findings may have clinical implications for the anti-platelet management of TAVI patients.

Type of Atrial Fibrillation and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement.

BACKGROUND: There are limited data available regarding the relationship between atrial fibrillation (AF) clinical type, oral anticoagulation (OAC) treatment, and clinical outcome after transcatheter aortic valve replacement (TAVR). The study was designed to evaluate this relationship. METHODS: We analyzed data from the Rabin Medical Center TAVR registry, including 319 consecutive patients who underwent TAVR from 2008 to 2014. Patients were divided into three groups based on their history of AF: sinus rhythm (SR), paroxysmal AF (PAF), or nonparoxysmal AF (NPAF). RESULTS: There were 211 (66%), 56 (18%), and 52 (16%) patients in the SR, PAF, and NPAF groups, respectively. The cumulative risk for stroke or death at 2 years was highest among patients with NPAF (38%), but similarly low in PAF (15%) and SR patients (16%, P < 0.001). By multivariate analysis, patients with NPAF demonstrated a significantly higher risk of stroke or death (HR = 2.76, 95% CI 1.63-4.66, P < 0.001), as compared with SR. In contrast, patients with PAF had a similar risk of stroke or death compared with SR (HR = 0.80, P = 0.508). Patients with NPAF not treated with OAC demonstrated an 8.3-fold (P < 0.001) increased risk of stroke or death, whereas patients with PAF not treated with OAC had a similar risk of stroke or death compared with the SR group (HR = 1.25, P = 0.569). CONCLUSION: History of NPAF, but not PAF, is associated with a significant increased risk of stroke or death compared with sinus rhythm in patients undergoing TAVR.

Treatment of Aortic, Mitral and Tricuspid Structural Bioprosthetic Valve Deterioration Using the Valve-in-Valve Technique.

BACKGROUND AND AIM OF THE STUDY: The percutaneous approach for a failed bioprosthetic valve is an emerging alternative to redo-valve surgery in patients at high surgical risk. The study aim was to describe the treatment of patients with structural bioprosthetic valve deterioration, using the valve-in-valve technique. METHODS: A total of 33 consecutive patients with symptomatic structural bioprosthetic valve deterioration was treated at the authors' institution, using the valve-in-valve technique. RESULTS: The valve-in-valve procedure in the aortic position was performed in 23 patients (mean age 81.4 ± 5.9 years; mean STS score 9.6 ± 5.4). The self-expandable and balloon-expandable devices were used in 21 cases (91.3%) and two cases (8.7%), respectively. Procedures were performed via the trans-femoral, trans-axillary and trans-apical routes in 18 (78.2%), three (13%) and two (8.7%) cases, respectively. After the procedure, all patients were in NYHA class I/II. Survival rates were 95.6% at the one-year follow up. The valve-in-valve procedure in the mitral position was performed in 10 patients (mean age 73.6 ± 15 years; mean STS score 7.7 ± 4.1). All procedures were performed using the balloon-expandable device via the trans-apical route. The composite end point of device success was achieved in all patients. Survival rates were 100% and 75% at one month and two years' follow up, respectively. A single valve-in-valve implantation within a failed tricuspid bioprosthetic valve was also successfully performed. CONCLUSION: In the authors' experience, the valve-in-valve technique for the treatment of a wide range of bioprosthetic valve deterioration modes of failure in different valve positions is safe and very effective.

Determinants of Left Ventricular Mass Regression in Patients with Severe Symptomatic Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation.

BACKGROUND AND AIM OF THE STUDY: The dynamics of left ventricular mass (LVM) regression following the relief of chronic left ventricular pressure overload are prone to variation. The study aim was to identify determinants of LVM regression following transcatheter aortic valve implantation (TAVI). METHODS: A total of 134 patients undergoing TAVI was identified. A retrospective analysis was performed of LVM indexed to body surface area (LVMi), calculated using transthoracic echocardiography at baseline and at six to 12 months post-TAVI. RESULTS: At six to 12 months after TAVI, there was a significant reduction in mean LVMi (from 118.2 ± 26.67 g/m2 to 103.4 ± 27.07 g/m2; p < 0.001) driven by a decrease in left ventricular wall thickness. The relative wall thickness (RWT) was decreased (0.54 ± 0.10 cm versus 0.51 ± 0.09 cm; p = 0.006), whereas the prevalence of concentric remodeling (RWT ≥ 0.42) remained unchanged (85.1% versus 80.6%; p = 0.3). However, 47 patients (35.1%) demonstrated significant LVMi regression, but had a lower baseline LVMi than patients who demonstrated significant regression (109.8 ± 25.8 g/m2 versus 122 ± 26.1 g/m2; p = 0.008) but had otherwise similar characteristics. A greater magnitude of LVMi reduction was associated with a greater baseline LVMi (r = 0.39; p < 0.001), where patients with LVMi in the highest quartile had the most substantial reduction in LVMi (p < 0.001). Multivariable analysis identified pre-TAVI LVMi as the sole independent predictor of LVMi regression at six to 12 months post-TAVI (P = 0.45; 95% confidence interval 0.255-0.534; p < 0.001). CONCLUSION: LVM regression at six to months post-TAVI was variable, with about one-third of patients not showing a significant regression. Only baseline LVM predicted LVM regression; patients with a higher baseline LVM demonstrated a greater regression.

The Impact of Transcatheter Aortic Valve Implantation on Mitral Regurgitation Regression in High-Risk Patients with Aortic Stenosis.

BACKGROUND AND AIM OF THE STUDY: In patients with aortic stenosis, mitral regurgitation (MR) is a common finding. Little is known regarding outcomes of MR in patients undergoing transcatheter aortic valve implantation (TAVI). The study aim was to characterize the short- and mid-term impact of the TAVI procedure on MR grade. METHODS: A total of 261 patients (59% females; mean age 82.1 +/- 6.9 years) undergoing TAVI was assessed for rates of significant MR and the severity of MR at baseline, and at one month and six months after the procedure. RESULTS: In patients with moderate MR or above at baseline (n = 26, 10% of the cohort), there was a mean reduction in grade of 1.5 +/- 1.1 and 1.8 +/- 1.4 after one and six months, respectively (p < 0.01). Reduction in MR grade (1+) at six months was identified in 54.1% (40/74) of patients with mild-moderate MR or greater, and in 88.5% (23/26) of those with moderate MR or above, and was associated with an improved NYHA functional class (correlation coefficient r = -0.294, p < 0.001). Multivariate analysis identified low pulmonary pressure and tricuspid regurgitation as independent predictors of improvements in MR. CONCLUSION: Among the present cohort of patients undergoing TAVI, those with MR at baseline showed an improvement in the severity of their MR. Patients with moderate MR regurgitation or above demonstrated the greatest improvement.

Circulating reticulated platelets over time in patients with myocardial infarction treated with prasugrel or ticagrelor.

Reticulated platelets (RP) are young, hyperactive platelets that are increased during situations of enhanced platelet turnover such as acute myocardial infarction (AMI). The dynamics of RP levels after AMI is not established. We aimed to characterize the levels of circulating RP over time in patients with AMI. Patients with AMI treated with ticagrelor or prasugrel who underwent percutaneous coronary intervention (PCI) were tested for circulating RP using flow cytometry with Thiazole orange staining at 3 time points at 2-4 days, 30-60 days and 1 year post PCI. Platelet reactivity was assessed using the VerifyNow P2Y12 assay at these time points (results in platelet reactivity units-PRU). Thirty-five patients were included in the study (mean age 62.6 ± 9.1 years, 82.9 % males). Median RP levels were similar at the first and second time points (17.5 %, IQR 25-75: 10.8-22.4 % and 14.9 %, IQR 25-75: 9.7-26.8 %, respectively; p = 0.75). However, RP levels after 1 year were significantly lower as compared to the first and second time points (10.5 % (IQR 25-75: 5.3-18.1 %), p = 0.005 and p = 0.01, respectively). Residual platelet reactivity was very low at all 3 time points (median PRU 25, IQR 25-75: 7-53) and did not change significantly between them (p = 0.66). No significant correlation was found between levels of RP and PRU at any given time point. RP levels of patients with AMI treated with prasugrel or ticagrelor decrease over time after the acute event. However, RP levels over time do not correlate well with residual platelet reactivity.

C-THV measures of self-expandable valve positioning and correlation with implant outcomes.

BACKGROUND: Accurate positioning of the valve device during transcutaneous aortic valve implantation (TAVI) is of crucial importance. The Paieon C-THV navigation system has been designed to correctly guide device deployment during TAVI. OBJECTIVES: Using this navigation system we aimed to determine the correlation between the anatomic measures of the native aortic valve and the deployed self-expandable valve positioning and to explore the impact upon procedural outcomes. METHODS: We analyzed data of 68 patients with severe symptomatic aortic stenosis undergoing TAVI, using the catheter-based Medtronic-CoreValve self-expandable system. Patients were subdivided into two groups according to whether the C-THV system was used (50) or not (18) during the implantation process. Analysis of geometrical outcomes vs. clinical outcomes including postprocedural electrical conduction defect and/or para-valvular leaks was performed. RESULTS: Taking the target implantation line as a reference; relatively lower vs. higher implantations correlated with a higher frequency of any new onset electrical conduction defect (ECD). The mean corresponding distance from valve inferior edge below the virtual aortic annulus line was 3.0 ± 1.6 mm vs. 1.2 ± 1.3 mm in patients with (38.5%) vs. without any new onset ECD, respectively (P = 0.05). The use of C-THV navigation seemed to correlate with higher valve implants but it had no impact on the occurrence of postprocedural paravalvular leaks. CONCLUSIONS: Self-expandable valve implants guided by C-THV navigation seems to be associated with more precise implants and lower risk for postprocedural electrical conduction defects, due to higher location in relation to the target line.

Outcomes of Drug-Eluting Balloons for In-Stent Restenosis: Large Cohort Analysis and Single-Center Clinical Experience.

BACKGROUND: The use of drug-eluting balloons (DEBs) remains clinically relevant in the contemporary era of drug-eluting stent percutaneous coronary interventions (DES-PCI), especially in the setting of in-stent restenosis (ISR). Our goal was to assess the outcomes of ISR patients in a large prospective registry. METHODS: A total of 2329 consecutive patients with ISR-PCI (675 using DEB and 1654 with DES) were treated in our medical centre from 2010 to 2021. Clinical end points included mortality and major adverse cardiac events (MACE) at 1 year. Clinical outcomes were adjusted for multiple confounders. RESULTS: Mean ages (65.9 ± 11.0 vs 66.1 ± 10.5; P = 0.73) and percentages of female patients (16.6% vs 18.2%; P = 0.353) were similar between both ISR groups. Patients treated with DEB for ISR suffered more from diabetes, hypertension, and previous myocardial infarction (P < 0.01 for all) and presented more frequently with acute coronary syndrome (40.0% vs 34.4%; P = 0.01) compared with patients treated with DES for ISR. One-year MACE was significantly higher in the DEB ISR-PCI group (23.4% vs 19.6%; P = 0.002) compared to the DES ISR-PCI group, but no significant differences in mortality were observed at 1 year between the groups. After adjustment for multiple confounders, DEB ISR-PCI was not associated with increased MACE at 1 year (P = 0.55). CONCLUSIONS: In our large experience, patients treated with DEB for ISR-PCI have higher baseline risk and sustained increased MACE rates compared with DES ISR-PCI patients. After adjustment for confounding variables, clinical outcomes are similar between the groups at 1 year after PCI.

Is 90 the new 80? Temporal trends in nonagenarians undergoing percutaneous coronary interventions.

BACKGROUND: Coronary artery disease (CAD) is a leading cause of death in the elderly population. Data regarding percutaneous coronary interventions (PCIs) in nonagenarians are scarce, and differences in long term outcomes between generations remain unclear. We aimed to study the pattern and temporal trends of nonagenarians treated with PCI. MATERIALS AND METHODS: A total of 14,695 patients underwent PCI between 2009-2020. We identified 2,034 (13.8%) octogenarians (age 80-89), and 222 (1.5%) nonagenarians (age 90-99). Endpoints included mortality and major adverse cardiac events (MACE) at 1 year. MATERIALS AND METHODS: A total of 14,695 patients underwent PCI between 2009-2020. We identified 2,034 (13.8%) octogenarians (age 80-89), and 222 (1.5%) nonagenarians (age 90-99). Endpoints included mortality and major adverse cardiac events (MACE) at 1 year. RESULTS: The number of nonagenarians undergoing PCI has increased substantially during the study time period, from 89 patients in the earlier time period (2009-2014) to 133 patients in the later time period (2015-2020). At 1-year, nonagenarians had significantly higher rates of both death (24.3% vs. 14.9%, p<0.01), and MACE (30.6% vs. 22.0%, p<0.01), as compared to octogenarians. The cumulative survival rate was higher among octogenarians both in the early and late time period (p<0.01 and p=0.039, respectively). A significant reduction in nonagenarian MACE rates were observed during the study time period, resulting in a non-significant difference in MACE rates in the later time period between both groups. CONCLUSION: The number of nonagenarians who undergo PCI is on the rise. While their clinical outcomes are inferior as compared to younger age groups, improvement was noted in the late time period.

The Impact of Cerebral Embolic Protection Devices on Characteristics and Outcomes of Stroke Complicating TAVR.

BACKGROUND: Acute ischemic stroke remains a serious complication of transcatheter aortic valve replacement (TAVR). Cerebral embolic protection devices (CEPD) were developed to mitigate the risk of acute ischemic stroke complicating TAVR (AISCT). However, the existing body of evidence does not clearly support CEPD efficacy in AISCT prevention. OBJECTIVES: In a cohort of patients with AISCT, we aimed to compare the characteristics and outcomes of patients who have had unprotected TAVR (CEPD-) vs CEPD-protected TAVR (CEPD+). METHODS: Data were derived from an international multicenter registry focusing on AISCT. We included all patients who experienced ischemic stroke within 72 hours of TAVR. Stroke severity was assessed using the National Institutes of Health Stroke Scale (NIHSS). Primary outcomes were neurologic disability status according to the modified Rankin Score at 30 days, and 6-month all-cause death. Propensity score matched analysis was used to control for differences between groups. RESULTS: In 18,725 TAVR procedures, 416 AISCT (2.2%) within 72 hours were documented, of which 376 were in the CEPD- TAVR group and 40 in the CEPD+ TAVR group. Although the middle cerebral artery stroke rate was similar in both groups (29.7% CEPD- vs 33.3% CEPD+; P = 0.71), AISCT in the CEPD+ group was characterized by a lower rate of internal carotid artery occlusion (0% vs 4.7%) and higher rate of vertebrobasilar system strokes (15.4% vs 5.7%; P = 0.04). AISCT was severe (NIHSS ≥15) in 21.6% CEPD- and 23.3% CEPD+ AISCT (P = 0.20). Disabling stroke rates (modified Rankin Score >1 at 30 days) were 47.3% vs 42.5% (P = 0.62), and 6-month mortality was 31.3% vs 23.3% (P = 0.61), in the CEPD- and CEPD+ groups, respectively. In the propensity score matched cohort, disabling stroke rates were 56.5% vs 41.6% (P = 0.16), and 6-month mortality was 33% vs 19.5% (P = 0.35), in the CEPD- and CEPD+ groups, respectively. CONCLUSIONS: In a large cohort of patients with AISCT, the use of CEPD had little effect on stroke distribution, severity, and outcomes.

The independent impact of dementia in patients undergoing percutaneous coronary intervention for acute myocardial infarction.

BACKGROUND: Although age and frailty are associated with worse prognoses for patients who undergo percutaneous coronary intervention (PCI), little is known regarding the independent impact of dementia. HYPOTHESIS: The aim of this study was to evaluate the association between dementia and outcomes for patients with acute myocardial infarction (AMI). METHODS: Consecutive patients with ST-elevation or non-ST elevation MI who had undergone PCI as part of our AMI registry were included in this study. We compared outcomes within the 1-year period of their PCI, including death and major adverse cardiac events (MACE) and corrected for confounders using Cox regression. RESULTS: Of 28 274 patients, 9167 patients who had undergone PCI for AMI were included in this study, 250 with dementia; Mean age (77.4 ± 9.4 in the dementia group vs. 63.6 ± 12.7 in the control), female gender (32.4 vs. 24.2%, p = .003), diabetes mellitus (54.0 vs. 42.4%, p < .001) and chronic kidney disease (44.4 vs. 19.3%, p < .001) were higher. At 12 months, unadjusted rates of death (25.5 vs. 9.8%, p < .001) and MACE (33.8 vs. 17.6%, p < .001) were higher for patients with dementia. After standardizing for confounding variables, dementia remained an independent risk factor for death (HR 1.90; CI 1.37-2.65; p < .001) and MACE (HR 1.73; CI 1.30-2.31; p < .001), as well as in propensity score matched analysis (HR 1.54; CI: 1.03-2.28; p < .001 and HR 1.49; CI: 1.09-2.02; p < .001, respectively). CONCLUSIONS: Dementia is an independent predictor of worse outcomes in patients undergoing PCI for AMI. Future intervention and specialized healthcare measures to mitigate this risk is warranted.

Noninvasive Hemodynamic Evaluation Following TAVI for Severe Aortic Stenosis.

Background Various hemodynamic changes occur following transcatheter aortic valve implantation (TAVI) that may impact therapeutic decisions. NICaS is a noninvasive bioimpedance monitoring system aimed at hemodynamic assessment. We used the NICaS system in patients with severe aortic stenosis (AS) to evaluate short-term hemodynamic changes after TAVI. Methods and Results We performed hemodynamic analysis using NICaS on 97 patients with severe AS who underwent TAVI using either self-expandable (68%) or balloon-expandable (32%) valves. Patients were more often women (54%) and had multiple comorbidities including hypertension (83%), coronary artery disease (46%), and diabetes (37%). NICaS was performed at several time points-before TAVI, soon after TAVI, at hospital discharge, and during follow-up. Compared with baseline NICaS measurements, we observed a significant increase in systolic blood pressure and total peripheral resistance (systolic blood pressure 132±21 mm Hg at baseline versus 147±23 mm Hg after TAVI, P<0.001; total peripheral resistance 1751±512 versus 2084±762 dynes*s/cm5, respectively, P<0.001) concurrent with a decrease in cardiac output and stroke volume (cardiac output 4.2±1.5 versus 3.9±1.3 L/min, P=0.037; stroke volume 61.4±14.8 versus 56.2±15.9 mL, P=0.001) in the immediate post-TAVI period. At follow-up (median 59 days [interquartile range, 40.5-91]) these measurements returned to values that were not different from the baseline. A significant improvement in echocardiography-based left ventricular ejection fraction was observed from baseline to follow-up (55.6%±11.6% to 59.4%±9.4%, P<0.001). Conclusions Unique short-term adaptive hemodynamic changes were observed using NICaS in patients with AS soon after TAVI. Noninvasive hemodynamic evaluation immediately following TAVI may contribute to the understanding of complex hemodynamic changes and merits favorable consideration.

The Impact of Sex on Cardiogenic Shock Outcomes Following ST Elevation Myocardial Infarction.

BACKGROUND: 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. METHODS: 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). RESULTS: 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, p < 0.01), and more had hypertension (68.3 vs. 52.8%, p = 0.019) and diabetes (38.7 vs. 24.8%, p = 0.047). Fewer were smokers (13.3 vs. 41.2%, p < 0.01), had previous PCI (9.1 vs. 22.3% p = 0.016), or required IABP (35.3 vs. 51.1% p = 0.027). Women had higher rates of mortality (53.2 vs. 35.3% in-hospital, p = 0.01; 61.3 vs. 41.9% at 1 month, p = 0.01; and 73.8 vs. 52.6% at 3 years, p = 0.05) and MACE (60.6 vs. 41.6% in-hospital, p = 0.032; 66.1 vs. 45.6% at 1 month, p = 0.007; and 62.9 vs. 80.3% at 3 years, p = 0.015). After multivariate adjustment, female sex remained an independent factor for death (HR-2.42 [95% CI 1.014-5.033], p = 0.042) and MACE (HR-1.91 [95% CI 1.217-3.031], p = 0.01). CONCLUSIONS: 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.