Percutaneous coronary intervention with ridaforolimus eluting-stents in small vessel coronary artery disease.

INTRODUCTION: The ridaforolimus-eluting stent (RES) system uses a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting ridaforolimus. AIM OF STUDY: To assess the safety and efficacy of small diameter (2.25 mm) RES (EluNIR) in small coronary artery disease. METHODS: A prospective, multicenter, single-arm, open-label clinical trial. Clinical follow-up was performed at 30 days, 6 months, and 1 year after the procedure. Target lesions were located in native coronary arteries or bypass graft conduits, with visually estimated diameter of ≥2.25 mm to ≤2.5 mm. The primary endpoint was combined device success, defined as final in-stent residual diameter stenosis <30%, without 30-day major adverse cardiovascular events (MACE). RESULTS: A total of 81 patients were enrolled in the study. Twenty-three patients (28%) had acute coronary syndrome (ACS) at presentation and 37 (46%) had prior myocardial infarction (MI). Most of the target lesions were located in the circumflex coronary artery (44%) and were classified as B2/C grade according to the American Heart Association/American College of Cardiology classification. The final mean minimal lumen diameter, mean reference vessel diameter, and mean residual percent diameter stenosis were 2.0 ± 0.2 mm, 2.3 ± 0.1 mm, and 14 + 6.6%, respectively. The primary endpoint of device success without 30-day MACE was achieved in 98.8% of the patients. Target lesion failure (TLF) at 6 months was 1.2%. Thirty-day and 1-year MACE rates were 1.2% and 2.5%, respectively. CONCLUSION: The EluNIR 2.25 mm stent shows excellent results in small coronary artery disease and adds another tool in the treatment of this complex lesion type.

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.

Preoperative evaluation of pulmonary hypertension in lung transplant candidates: echocardiography versus right heart catheterization.

BACKGROUND: Right heart catheterization (RHC) and echocardiography are both routinely used for pulmonary artery systolic pressure (PASP) assessment in lung transplantation (LT) candidates, although this is not mandated by current guidelines. We aimed to explore the performance of echocardiographic PASP as an indicator of pulmonary hypertension in LT candidates, in order to assess the necessity of RHC. METHODS: From a retrospective registry of 393 LT candidates undergoing RHC and echocardiography during 2015-2019, patients were assessed for the presence of pulmonary hypertension (PH), defined as mean pulmonary artery pressure (mPAP) above 20 mmHg, according to two methods-echocardiography and RHC. The primary outcome was the correlation between the PASP estimated by echocardiography to that measured by RHC. Secondary outcomes were the prediction value of the echocardiographic evaluation and its accuracy. RESULTS: The mean value of PASP estimated by echocardiography was 49.5 ± 20.0 mmHg, compared to 42.5 ± 18.0 mmHg measured by RHC. The correlation between the two measurements was moderate (Pearson's correlation: r = 0.609, p < 0.01). Echocardiography PASP measurements were moderately discriminative to diagnose PH, with an area under the curve (AUC) of 0.72 (95% CI 0.66-0.77). Echocardiographic overestimation of PASP of more than 10 mmHg was found in 35.0% of the patients, and underestimation was found in 11.6% of the patients. CONCLUSION: In the pre-surgical evaluation of LT candidates, echocardiographic estimation of PASP had moderate correlation and limited accuracy compared to the PASP measured by RHC. We thus recommend performing routine RHC to all LT candidates, regardless of the echocardiographic estimation of PASP.

Percutaneous mechanical circulatory support from the collaborative multicenter Mechanical Unusual Support in TAVI (MUST) Registry.

OBJECTIVES: To evaluate the use and outcomes of percutaneous mechanical circulatory support (pMCS) utilized during transcatheter aortic valve implantation (TAVI) from high-volume centers. METHODS AND RESULTS: Our international multicenter registry including 13 high-volume TAVI centers with 87 patients (76.5 ± 11.8 years, 63.2% men) who underwent TAVI for severe aortic stenosis and required pMCS (75.9% VA-ECMO, 19.5% Impella CP, 4.6% TandemHeart) during the procedure (prior to TAVI 39.1%, emergent rescue 50.6%, following TAVI 10.3%). The procedures were considered high-risk, with 50.6% having severe left ventricular dysfunction, 24.1% biventricular dysfunction, and 32.2% severe pulmonary hypertension. In-hospital and 1-year mortality were 27.5% and 49.4%, respectively. Patients with prophylactic hemodynamic support had lower periprocedural mortality compared to patients with rescue insertion of pMCS (log rank = 0.013) and patients who did not undergo cardiopulmonary resuscitation during the TAVI procedure had better short and long term survival (log rank <0.001 and 0.015, respectively). CONCLUSIONS: Given the overall survival rate and low frequency of pMCS-related complications, our study results support the use of pMCS prophylactically or during the course of TAVI (bailout) in order to improve clinical outcomes in high-risk procedures or in case of acute life-threatening hemodynamic collapse.

Timing of Nonculprit Percutaneous Coronary Intervention after ST-Elevation Myocardial Infarction.

INTRODUCTION: Complete revascularization of ST-elevation myocardial infarction (STEMI) patients with multivessel disease (MVD) has recently shown to reduce risk of adverse cardiovascular events, including cardiovascular death. Optimal timing of revascularization of nonculprit lesions remains controversial. We aimed to measure cardiac outcomes related to duration between primary percutaneous coronary intervention (pPCI) of the culprit lesion and staged PCI (sPCI) of nonculprit lesions. METHODS: From a prospectively collected consecutive registry of 3,002 patients treated for STEMI by pPCI, 1,555 patients with MVD requiring sPCI were identified. Patients were placed into quartiles of duration to sPCI: 0-7 days (Q1), 7-22 days (Q2), 22-42 days (Q3), >42 days (Q4), excluding those who had complete revascularization at the index event. Major adverse cardiac events (MACEs) included all-cause mortality, myocardial infarction, target vessel revascularization, and coronary artery bypass surgery. Cox regression and propensity score matching were performed correcting for confounding factors. RESULTS: The average age at presentation was 65.7 ± 11.5 years. 333 were female (21.4%). Mean time between pPCI and sPCI was 28.3 days (±24.8). Rates of MACE were Q1 - 16.5%, Q2 - 21.2%, Q3 - 25.8%, and Q4 - 30.1% (log-rank <0.001). Following regression analysis, sPCI remained an independent risk factor for MACE (hazard ratio [HR] = 1.226 [95% confidence interval {CI}: 1.129-1.331, p < 0.001]). There was no association between the time interval up to sPCI with all-cause death (HR = 1.022 [95% CI: 0.925-1.129, p = 0.671]). CONCLUSIONS: Patients with MVD are at increased risk of experiencing MACE after revascularization of nonculprit vessels with increasing time delay between pPCI and sPCI.

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.

Outcomes of primary percutaneous cardiac intervention for ST elevation myocardial infarction with a saphenous vein graft culprit.

BACKGROUND: Patients treated with primary percutaneous coronary intervention (pPCI) for ST elevation myocardial infarction (STEMI) who have a history of coronary artery bypass grafting (CABG) are at high risk of adverse cardiovascular outcomes. Data on the risk of a saphenous vein graft (SVG)-infarct-related artery (IRA) compared to other culprit vessels are sparse. METHODS: The study was based on a prospectively collected registry of 2,405 consecutive patients with STEMI attending a tertiary medical center in 2001-2017. Patients with an SVG-IRA (n = 172) were compared with patients with native vessel disease (n = 2,333) for mortality and major adverse cardiac events (MACE), which included death, myocardial infarction (MI), target vessel revascularization (TVR), and coronary artery bypass surgery (CABG) at 1 month and 3 years. RESULTS: The SVG-IRA group was significantly older than the native vessel group (p = .05), with no between-group differences in rates of male patients (76 vs. 82%, p = .59), diabetes (24.2 vs. 26.2%, p = .73), and renal failure (18.8 vs. 9.2%, p = .25). Mortality was higher in the SVG-IRA group at 1 month (13.9 vs. 2.5%, p < .01) and 3 years (23.9 vs. 7.4%, p < .01). At 3 years, SVG-IRA was associated with the highest rates of MACE (55.6%), compared with native vessel disease. After correction for confounders, SVG-IRA remained an independent risk factor for MACE both at 1 month (HR-2.08, 95%CI 1.72-3.11, p < .01) and 3 years (HR-2.01, 95%CI 1.28-3.09, p < .01). CONCLUSION: Among patients treated with pPCI for STEMI, outcomes are worse when the culprit is an SVG.

Percutaneous nitinol-based vascular closure device for large bore arterial access hemostasis: Results of a prospective multicenter study.

BACKGROUND: Vascular complications during transcatheter aortic valve replacement (TAVR) still pose a significant concern regarding procedural safety. Designated closure devices for large-bore vascular access are needed. METHODS: Patients undergoing TAVR were prospectively enrolled into the study. The InSeal vascular closure device (VCD) achieves hemostasis by utilizing a crescent-shaped nitinol scaffold covered by a biodegradable membrane, which is delivered at the arterial puncture site. The coprimary endpoints were predefined as hemostasis within 15 min following vessel access site closure and after activated clotting time falls below 200 s and the rate of related major vascular adverse events in first month. RESULTS: A total of 50 patients were prospectively enrolled into the study, with an average age of 80.8 ± 7.4 years and 62% males. Hemostasis with the Inseal VCD was achieved in 94% of the patients with average time-to-hemostasis of 51 ± 97 s. The rates of in-hospital vascular complications were 12% mostly driven by minor vascular complications (10%). Femoral artery stents were used in three patients due to failed hemostasis. CONCLUSIONS: Initial clinical experience indicates that a novel, nitinol-based, large-bore vascular closure device is safe and effective in achieving hemostasis after TAVR.

Prognostic significance of the Medina classification in bifurcation lesion percutaneous coronary intervention with second-generation drug-eluting stents.

The Medina classification is the most widespread method to describe bifurcation lesions. However, little is known regarding its prognostic impact. Therefore, the aim of this study is to assess the prognostic significance of the Medina classification following percutaneous coronary intervention (PCI). From a prospective registry of 738 consecutive patients undergoing PCI for bifurcation lesions, 505 were treated with second-generation drug-eluting stents (DES). Of these, 407 (80.6%) presented with "true bifurcation" (TB) lesions (Medina class 1.0.1, 1.1.1, 0.1.1) and 98 (19.4%) in all other categories ("non-true bifurcation" = NTB). We compared rates of death and major adverse cardiac events (MACE: cardiac death, myocardial infarction, or target vessel revascularization) at 12 months and 3 years. Patients with TB had lower rates of previous bypass surgery (7.4% vs. 11.2%, p = 0.043). TB lesions were more likely to be calcified (33.9% vs. 28.6%, p = 0.003) and ulcerated (8.8% vs. 4.1%, p < 0.01). At 12 months, mortality was numerically higher for TB PCI (4.1% vs. 2.1%, p = 0.052) and MACE rates were higher (19.2% vs. 10.2%, p < 0.001). At 3 years, both all-cause death (10.1% vs. 5.1%, p = 0.002) and rates of MACE (37.2% vs. 17.6%, p < 0.001) were higher for TB PCI. After performing regression analysis, TB remained an independent predictor for poor outcomes (OR-2.28 at 12 months, CI 1.45-9.50, p = 0.007, OR-3.75 at 3 years, CI 1.52-6.77, p = 0.001 for MACE). In conclusion, TB lesions, according to the Medina classification, portend worse prognosis for patients undergoing bifurcation PCI. This may guide prognostication and decision-making in treatment.

[DIFFERENT ANESTHESIA APPROACHES IN THE TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE AND THEIR POSSIBLE EFFECT ON MORBIDITY AND MORTALITY].

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is used in patients with severe aortic stenosis (AS) who are at high surgical risk. Pre- and post-operative management is challenging as these patients are older, have significant comorbidities and a very high expected mortality rate in conventional surgery. There is no consensus in the literature about the preferred form of anesthesia, however, currently most centers perform the procedure using local anesthesia with sedation (LA-S). OBJECTIVES: To compare general anesthesia (GA) and LA-S in patients undergoing TAVI. METHODS: A retrospective review of the first 100 patients who underwent TAVI (11/2008-6/2011) at the Rabin Medical Center, due to severe and symptomatic AS and a counter-indication for conventional valve replacement surgery. RESULTS: A total of 46 patients underwent the procedure with GA and 54 with LA-S. In 63 patients, the transfemoral approach was used, transapical in 23, and transaxillary in 11. There were no significant differences in short- and long-term mortality, but average hospitalization was longer in the GA group. A larger proportion of patients needed norepinephrine and blood transfusions during the procedure in the GA group. In the LA-S group, more conduction, vascular complications and postoperative fever were observed. In comparisons between anesthesia methods with the transfemoral approach, most of the differences lost their significance. Therefore, these differences are most likely attributed to the surgical approach and not to the anesthesia method. CONCLUSIONS: There is no clear preference for GA in TAVI. LA-S appears to be an effective and safe option for eligible patients.

Long-term Israeli Single-Center Experience with the Percutaneous MitraClip Procedure.

BACKGROUND: The MitraClip procedure is becoming an acceptable alternative for high-risk patients with mitral regurgitation (MR) due to functional (FMR) or degenerative (DMR) disease and suitable mitral anatomy. OBJECTIVES: To evaluate the results of MitraClip at our institute in carefully selected patients. METHODS: We conducted a retrospective analysis of medical records and echocardiography data from January 2012 to December 2017. RESULTS: A total of 39 MitraClip procedures in 37 patients (aged 75 ± 12 years, 9 women) was performed. Twenty-four patients presented with FMR, 12 with DMR, and 1 with combined pathology. One-day post-procedure MR was moderate to low in 86.1% of patients, with immediate device success in 88.8%. MR at 1 year was moderate to low in 79% at 1 year. Survival at 1 year was 86% and at 2 years 69.4%. Peri-procedural (< 1 week) death and MitraClip failure occurred in one and three patients, respectively. New York Heart Association score improved to class 1 or 2 in 37% of patients at 1 year vs. one patient at baseline. Post-procedural systolic pulmonary pressure was reduced from 53 (range 48-65) to 43 (range 36-52) mmHg at 1 month with a subsequent plateau at follow-up, to 41 (34-57) mmHg at 6 months, and to 47 (38-50) at 12 months. CONCLUSIONS: MitraClip in severe MR resulted in modest improvement in functional status and pulmonary pressure with a small risk of immediate procedural complications. Outcomes are encouraging considering the natural course of MR and the risks of surgical intervention.

Long-term Outcomes of Contemporary Coronary Revascularization by Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting in Young Adults.

BACKGROUND: Current guidelines for choosing between revascularization modalities may not be appropriate for young patients. OBJECTIVES: To compare outcomes and guide treatment options for patients < 40 years of age, who underwent percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) between 2008 and 2018. METHODS: Outcomes were compared for 183 consecutive patients aged < 40 years who underwent PCI or CABG between 2008 and 2018, Outcomes were compared as time to first event and as cumulative events for non-fatal outcomes. RESULTS: Mean patient age was 36.3 years and 96% were male. Risk factors were similar for both groups. Drug eluting stents were implemented in 71% of PCI patients and total arterial revascularization in 74% of CABG patients. During a median follow-up of 6.5 years, 16 patients (8.6%) died. First cardiovascular events occurred in 35 (38.8%) of the PCI group vs. 29 (31.1%) of the CABG group (log rank P = 0.022), repeat events occurred in 96 vs. 51 (P < 0.01), respectively. After multivariate adjustment, CABG was associated with a significantly reduced risk for first adverse event (hazard ratio [HR] 0.305, P < 0.01) caused by a reduction in repeat revascularization. CABG was also associated with a reduction in overall repeat events (HR 0.293, P < 0.01). There was no difference in overall mortality between CABG and PCI. CONCLUSIONS: Young patients with coronary disease treated by CABG showed a reduction in the risk for non-fatal cardiac events. Mortality was similar with CABG and PCI.

Temporal trends in percutaneous coronary interventions thru the drug eluting stent era: Insights from 18,641 procedures performed over 12-year period.

BACKGROUND: The last decade, regarded as the DES era in PCI, has witnessed significant advances in the management of coronary disease. We aimed to assess temporal trends in the practice and outcome of percutaneous coronary intervention (PCI) during the drug eluting stent (DES) era. METHODS: We analyzed 18,641 consecutive PCI's performed between January 2004 and December 2016, distinguished by procedural date (Q1 : 2004-2006, n = 4,865; Q2 : 2007-2009, n = 4,977; Q3 : 2010-2012, n = 4,230; Q4 : 2013-2016, n = 4,569). RESULTS: At presentation, mean patients age was 65 (±11) years and 22.8% were females. Over time, there was a rise in the relative number of octogenarians (Q1 : 10.7% vs Q4 : 15.5%, P < 0.001) and an increase in the burden of most comorbidities (e.g., left ventricular dysfunction ≥ moderate and chronic kidney disease, P < 0.001 for both). Despite a 2-fold increase in the rate of complex interventions, and a 3-fold increase in the rate of unprotected left-main angioplasty (P < 0.001 for both), the radial approach was increasingly adopted (Q1 : 2% to Q4 : 63.5%, P < 0.001). DES implantation increased from 43% to 83% at the expense of bare metal stent (BMS) application, and accompanied by drug coated balloon sprout to 1.8%, P < 0.001. Kaplan-Meier survival curves revealed a time-based enhanced outcome, with a decreased rate of death, MI, target vessel revascularization and CABG over the years. CONCLUSIONS: In the last decade, PCI has evolved to offer better outcome to more elderly, sicker patient population, with more complex coronary disease interventions. The shift to second generation DES and to enhanced PCI techniques may explain part of this progress.

Long Term Outcomes of MGuard Stent Deployment in Saphenous Vein Grafts and Native Coronary Arteries: A Single Center Experience.

BACKGROUND: The MGuard™ stent (InspireMD, Tel Aviv, Israel) is a bare metal mesh-covered stent, developed to prevent no-reflow phenomenon during percutaneous coronary intervention (PCI) of saphenous vein grafts (SVG) and acute myocardial infarction (MI), both associated with significant atherothrombotic lesions. OBJECTIVES: To report on local experience with patients treated with the MGuard stent until follow-up at 1 year. METHODS: We followed 163 consecutive patients who underwent MGuard stent deployment during the period 2009 to 2014 in a large tertiary cardiac center in central Israel. RESULTS: The MGuard stent was used in 67% of patients who underwent SVG-PCI while 33% were treated for native coronary artery disease, the majority during ST-elevation MI (STEMI). The mean age was 67 years and 83% were males. The clinical presentation was STEMI in 30% and non-STEMI/unstable angina in 60% of patients. Of the total number of patients, 47% had diabetes and 29% had chronic kidney disease. All patients had follow-up at 1 year. Mortality in the native group was 1.9% vs. 10% in the vein graft cohort. ST was 2% in both groups. The major adverse cardiac event (MACE) rates were 11% in the native artery and 29% in the vein graft group, mainly due to respective target lesion revascularization/target vessel revascularization rates of 6% and 7% in the native vessel group and 11% and 15% in the SVG group. CONCLUSIONS: In suitable patients undergoing SVG-PCI or native lesion intervention during acute MI, the MGuard stent is a viable treatment strategy. Its potential merits and limitations warrant further evaluation.

Aortic Valve Gradient and Clinical Outcome in Patients Undergoing Transcatheter Aortic Valve Implantation for Severe Aortic Stenosis.

OBJECTIVES: To explore the relation between the baseline aortic valve gradient (AVG) as a continuous variable and clinical outcomes following transcatheter aortic valve implantation (TAVI) in general and specifically in patients with high-gradient aortic stenosis (AS). METHODS: We reviewed 317 consecutive patients who underwent TAVI at our institution. We investigated the relation between AVG as a continuous/categorical variable and outcome among all patients and in patients without low-flow low-gradient AS, using the Cox proportional hazard model adjusting for multiple prognostic variables. RESULTS: Patients had a peak AVG of 79.9 ± 22.8 mm Hg (mean 50.5 ±15.7). During a mean follow-up of 2.7 years, AVG was inversely associated with mortality and mortality or cardiac hospitalization. Every 10-mm-Hg increase in peak AVG was associated with 18% reduction in mortality (p = 0.003) and 19% reduction in mortality/cardiac hospitalization (p < 0.001). Every 10-mm-Hg increase in mean AVG was associated with a 24% reduction in both outcomes (p = 0.005 and p < 0.001). Subgroup analysis of patients with left-ventricular ejection fraction >40% or peak AVG >64 mm Hg yielded similar results. CONCLUSIONS: Mean and peak baseline AVGs are directly associated with improved outcomes after TAVI; AVG can be used to select the patients most likely to benefit from TAVI.

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.

Insights from 2D and 3D Quantitative Angiographic Assessment of Bioresorbable Everolimus-Eluting Vascular Scaffolds.

BACKGROUND: Bioresorbable vascular scaffold (BVS) is a promising technology that potentially offers several advantages over contemporary coronary drug-eluting stents (DES). Crucial to BVS implantation is the correct choice of scaffold size (diameter and length) in order to avoid "geographic miss" in length, provide the maximal support to the vessel wall, and avoid leaving "free-floating" foreign material in the coronary vasculature. OBJECTIVES: To assess the optimal method for measuring coronary stenosis prior to BVS implantation. METHODS: We compared the performance of two quantitative coronary angiography assessment (QCA) techniques: two dimensional real-time QCA (2D-QCA) and offline 3D QCA (3D-QCA) for the evaluation of coronary lesions in patients enrolled in a multicenter randomized controlled trial of BVS vs. metallic stents, by calculating the weighted kappa value for agreement regarding optimal BVS size with the reference method - CoreLab offline 2D-QCA measurements..In addition, we collected 2 year clinical outcomes (death/myocardial infarction/repeat revascularization/scaffold thrombosis) in BVS-implanted patients. RESULTS: In 17 patients with available CoreLab data, the weighted kappa for agreement for 3D-QCA was significantly better than for 2D-QCA (0.90, 95%CI 0.72-1.00 vs. 0.439, 95%CI 0.16-0.77). The rate of clinical events at 2 years was low (9.5%). CONCLUSIONS: Initial experience in a small group of carefully selected patients at our institution, suggests that the use of BVS for coronary revascularization is associated with a low rate of adverse events in suitable patients. 3D-QCA may be superior to 2D-QCA analysis in terms of reproducibility, and results in more patients receiving optimal size BVS.