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BACKGROUND Accurate and timely ascertainment of clinical endpoints, particularly hospitalizations, is crucial for clinical trials. The TAILOR-PCI Digital Study extended the main TAILOR-PCI trial's follow-up period (NCT#01742117) to two years, utilizing a smartphone-based research app featuring geofencing-triggered surveys and routine monthly mobile surveys to detect cardiovascular (CV) hospitalizations. This pilot study compared these digital tools to conventional site-coordinator ascertainment of CV hospitalizations. OBJECTIVE The primary objectives were to evaluate the geofencing-triggered notifications and routine monthly mobile surveys' performance in detecting CV hospitalizations compared to telephone visits and health record reviews by study coordinators at each site. METHODS Participants in the United States and Canada from the TAILOR-PCI Digital Follow-up Study were invited to download the Eureka Research Platform mobile app, opting in for location tracking using geofencing, triggering a smartphone-based survey if near a hospital for ≥4 hours. Participants also received monthly CV hospitalization survey notifications. RESULTS Of the 85 participants who consented for the Digital Study, downloaded the mobile app and had not previously completed their final follow-up visit, 73 (85.8%) initially opted in and consented to geofencing. There were 9 CV hospitalizations ascertained by study coordinators in 5 patients, whereas 8/9 (88.9%) were detected by routine monthly hospitalization surveys. One CV hospitalization was missed by the survey since it occurred within 2 weeks of the previous hospitalization and the participant could only report a single hospitalization. Three of these were also detected by the geofencing algorithm, but 6/9 (66.7%) were missed by geofencing: one occurred in a participant that never consented to geofencing, while five hospitalizations occurred in participants which had subsequently (after consent) turned off geofencing prior to their hospitalization. Geofencing-detected hospitalizations were ascertained within a median of 2 (Q1, Q3:1-3) days, monthly surveys within 11 (IQR: 6.5–25) days, and site coordinator methods within 38 (Q1, Q3: 9-105) days. The geofencing algorithm triggered 245 notifications in 39 participants, with 128 (52.2%) from true hospital presence and 117 (47.8%) from non-hospital healthcare facility visits. Algorithm refinement increased the accuracy of true hospital visit alerts from 35.4% to 93.3%. CONCLUSIONS The monthly survey detected 8/9 CV hospitalizations, while the geofencing survey enabled earlier detection but did not offer incremental value. Digital tools could potentially reduce the burden on site study coordinators in ascertaining CV hospitalizations. The benefits of more timely reporting with geofencing must be balanced against false notifications which can be overcome with algorithm refinements. CLINICALTRIAL NCT#01742117

Background: Left ventricular outflow tract obstruction may occur following transcatheter mitral valve replacement in the setting of mitral annular calcification. Methods: We present a case series whereby preemptive septal radiofrequency ablation (RADIO-TMVR) was used to augment the left ventricular outflow tract for transcatheter mitral valve replacement in 4 patients at risk for left ventricular outflow tract obstruction despite alcohol septal ablation. Results: All patients were female, average age of 74.9 (68.8–80.4) years. Baseline ejection fraction was 71% (63%–75%). Mean mitral valve area was 1.28 (range, 1.0–1.59) cm 2 . Mean mitral valve gradient at rest was 9.5 (range, 7–11) mm Hg. New York Heart Association symptoms were III to IV at baseline. Patients underwent preemptive septal radiofrequency ablation to prevent left ventricular outflow tract obstruction with transcatheter mitral valve replacement a range between 69 and 154 days after alcohol septal ablation. Procedural time was 384 (337–424) minutes with a fluoroscopic time of 31 (14–71) minutes. Radiofrequency ablation time was 132 (100–175) minutes. As anticipated, 3 patients developed complete heart block and underwent pacemaker implantation, whereas 1 had a preexisting pacemaker. One patient developed groin hematoma and heart failure exacerbation. There were no peri-procedural deaths. Preemptive septal radiofrequency ablation to prevent left ventricular outflow tract obstruction with transcatheter mitral valve replacement resulted in septal end-diastolic wall thickness reduction compared with baseline (28.6%, 30.4%, 30.3%, and 11.1%) and following alcohol septal ablation (23.1%, 12%, 8.5%). Valve replacement in the setting of mitral annular calcification was performed in all patients 89 (range, 38–45) days after preemptive septal radiofrequency ablation to prevent left ventricular outflow tract obstruction with transcatheter mitral valve replacement. Two patients had concomitant laceration of the anterior mitral leaflet to further augment the neo-left ventricular outflow tract. Postprocedure, New York Heart Association symptoms improved to class I (3 patients) and class II (1 patient). Conclusions: In at-risk individuals, preemptive septal radiofrequency ablation may be an effective strategy at preventing left ventricular outflow tract obstruction with transcatheter mitral valve replacement.

Introduction: Unsupervised machine learning (ML) can provide insight into a dataset without significant expert time for annotation and labeling, but was never used to assess the heterogeneous MitraClip population. Hypothesis: We hypothesized that unsupervised k-means ML could identify prognostically-distinct phenogroups in MitraClip patients without a priori knowledge of the dataset. Methods: Patients who underwent MitraClip (June 2014-September 2020) at Mayo Clinic sites were identified from the Mayo institutional NCDR database for baseline and follow-up data. Variables with ≥ 50% missing data were excluded. A k-means algorithm was used for clustering analysis. Input variables were grouped according to 4 distinct k-means determined clusters. Kaplan-Meier survival analysis was used to assess the survival of each cluster. Results: A total of 389 consecutive patients were included in the final analysis, and 95 unique variables were used. The mean age was 80.3±8.7 years; 256 (65.8%) were male. The mean STS MV Replace score was 9.1±5.7. Fifty-five (14.5%) patients died during the mean follow duration (185 days). Kaplan-Meier analysis showed significant survival differences among clusters (Figure 1). The cluster (cluster 2, n=120) with best survival performance (all-cause mortality 3.3%) had features of non-calcified mitral leaflets, nonischemic cardiomyopathy, and less than moderate tricuspid regurgitation. Cluster 3 (n=66) had the worst survival performance (all-cause mortality 27.3%) and opposite features than cluster 2. Conclusions: Unsupervised ML can identify distinct phenotype clusters with prognostic significance in MitraClip patients. Patients with non-calcified mitral leaflets, nonischemic cardiomyopathy, and less than moderate tricuspid regurgitation are intrinsically different from other MitraClip patients and should be considered the potential optimal candidates.

To assess the impact of pulmonary hypertension (PH) on outcomes of patients with severe mitral annular calcification (MAC) undergoing transcatheter mitral valve replacement (TMVR).PH is associated with poor outcomes after mitral valve surgery. Whether the presence of PH in patients with MAC undergoing (TMVR) is associated with poor outcomes, is unknown.Retrospective evaluation of 116 patients from 51 centers in 11 countries who underwent TMVR with valve in mitral annular calcification (ViMAC) using balloon-expandable aortic transcatheter valves (THVs) from September 2012 to March 2017. Pulmonary artery systolic blood pressure (PASP) by echocardiogram was available in 90 patients. The subjects were stratified based on PASP: No PH = PASP ≤35 mmHg (n = 11); mild to moderate PH = PASP 36-49 mmHg (n = 21) and severe PH = PASP ≥50 mmHg (n = 58). Clinical, procedural, and echocardiographic outcomes were assessed.Mean age was 72.7 (±12.8) years, 59 (65.6%) were female, Society of Thoracic Surgeons score was 15.8 + 11.8% and 90.0% where in New York Heart Association (NYHA) class III-IV. There was no significant difference in all-cause mortality at 30 days (no PH = 27.3%, mild-moderate PH = 19.0%, severe PH = 31.6%; p = 0.55) or at 1 year (no PH = 54.5%, mild-moderate PH = 38.1%, severe PH = 56.1%; p = 0.36). No difference in adverse events, NYHA class or amount of residual mitral regurgitation at 1 year were observed between the groups.This study suggests that the presence of PH in patients with predominantly mitral stenosis with MAC undergoing TMVR does not impact mortality or adverse events. Further studies are needed to fully understand the effect of PH in this group of patients.

Background The Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention (TAILOR-PCI) Digital Study is a novel proof-of-concept study that evaluated the feasibility of extending the TAILOR-PCI randomized controlled trial (RCT) follow-up period by using a remote digital platform. Objective The aim of this study is to describe patients’ onboarding, engagement, and results in a digital study after enrollment in an RCT. Methods In this intervention study, previously enrolled TAILOR-PCI patients in the United States and Canada within 24 months of randomization were invited by letter to download the study app. Those who did not respond to the letter were contacted by phone to survey the reasons for nonparticipation. A direct-to-patient digital research platform (the Eureka Research Platform) was used to onboard patients, obtain consent, and administer activities in the digital study. The patients were asked to complete health-related surveys and digitally provide follow-up data. Our primary end points were the consent rate, the duration of participation, and the monthly activity completion rate in the digital study. The hypothesis being tested was formulated before data collection began. Results After the parent trial was completed, letters were mailed to 907 eligible patients (representing 18.8% [907/4837] of total enrolled in the RCT) within 15.6 (SD 5.2) months of randomization across 24 sites. Among the 907 patients invited, 290 (32%) visited the study website and 110 (12.1%) consented—40.9% (45/110) after the letter, 33.6% (37/110) after the first phone call, and 25.5% (28/110) after the second call. Among the 47.4% (409/862) of patients who responded, 41.8% (171/409) declined to participate because of a lack of time, 31.2% (128/409) declined because of the lack of a smartphone, and 11.5% (47/409) declined because of difficulty understanding what was expected of them in the study. Patients who consented were older (aged 65.3 vs 62.5 years; P=.006) and had a lower prevalence of diabetes (19% vs 30%; P=.02) or tobacco use (6.4% vs 24.8%; P Conclusions Extended follow-up after enrollment in an RCT by using a digital study was technically feasible but was limited because of the inability to contact most eligible patients or a lack of time or access to a smartphone. Among the enrolled patients, most completed the required electronic visits. Enhanced recruitment methods, such as the introduction of a digital study at the time of RCT consent, smartphone provision, and robust study support for onboarding, should be explored further. Trial Registration Clinicaltrails.gov NCT01742117; https://clinicaltrials.gov/ct2/show/NCT01742117

BACKGROUND The Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention (TAILOR-PCI) Digital Study is a novel proof-of-concept study that evaluated the feasibility of extending the TAILOR-PCI randomized controlled trial (RCT) follow-up period by using a remote digital platform. OBJECTIVE The aim of this study is to describe patients’ onboarding, engagement, and results in a digital study after enrollment in an RCT. METHODS In this intervention study, previously enrolled TAILOR-PCI patients in the United States and Canada within 24 months of randomization were invited by letter to download the study app. Those who did not respond to the letter were contacted by phone to survey the reasons for nonparticipation. A direct-to-patient digital research platform (the Eureka Research Platform) was used to onboard patients, obtain consent, and administer activities in the digital study. The patients were asked to complete health-related surveys and digitally provide follow-up data. Our primary end points were the consent rate, the duration of participation, and the monthly activity completion rate in the digital study. The hypothesis being tested was formulated before data collection began. RESULTS After the parent trial was completed, letters were mailed to 907 eligible patients (representing 18.8% [907/4837] of total enrolled in the RCT) within 15.6 (SD 5.2) months of randomization across 24 sites. Among the 907 patients invited, 290 (32%) visited the study website and 110 (12.1%) consented—40.9% (45/110) after the letter, 33.6% (37/110) after the first phone call, and 25.5% (28/110) after the second call. Among the 47.4% (409/862) of patients who responded, 41.8% (171/409) declined to participate because of a lack of time, 31.2% (128/409) declined because of the lack of a smartphone, and 11.5% (47/409) declined because of difficulty understanding what was expected of them in the study. Patients who consented were older (aged 65.3 vs 62.5 years; P=.006) and had a lower prevalence of diabetes (19% vs 30%; P=.02) or tobacco use (6.4% vs 24.8%; P<.001). A greater proportion had bachelor’s degrees (47.2% vs 25.7%; P<.001) and were more computer literate (90.5% vs 62.3% of daily internet use; P<.001) than those who did not consent. The average completion rate of the 920 available monthly electronic visits was 64.9% (SD 7.6%); there was no decrease in this rate throughout the study duration. CONCLUSIONS Extended follow-up after enrollment in an RCT by using a digital study was technically feasible but was limited because of the inability to contact most eligible patients or a lack of time or access to a smartphone. Among the enrolled patients, most completed the required electronic visits. Enhanced recruitment methods, such as the introduction of a digital study at the time of RCT consent, smartphone provision, and robust study support for onboarding, should be explored further. CLINICALTRIAL Clinicaltrails.gov NCT01742117; https://clinicaltrials.gov/ct2/show/NCT01742117

The aim of this study was to examine the effect of CYP2C19 genotype on clinical outcomes in patients with coronary artery disease (CAD) who predominantly underwent percutaneous coronary intervention (PCI), comparing those treated with ticagrelor or prasugrel versus clopidogrel.The effect of CYP2C19 genotype on treatment outcomes with ticagrelor or prasugrel compared with clopidogrel is unclear.Databases through February 19, 2020, were searched for studies reporting the effect of CYP2C19 genotype on ischemic outcomes during ticagrelor or prasugrel versus clopidogrel treatment. Study eligibility required outcomes reported for CYP2C19 genotype status and clopidogrel and alternative P2YOf 1,335 studies identified, 7 RCTs were included (15,949 patients, mean age 62 years; 77% had PCI, 98% had acute coronary syndromes). Statistical heterogeneity was minimal, and risk for bias was low. Ticagrelor and prasugrel compared with clopidogrel resulted in a significant reduction in ischemic events (relative risk: 0.70; 95% confidence interval: 0.59 to 0.83) in CYP2C19 loss-of-function carriers but not in noncarriers (relative risk: 1.0; 95% confidence interval: 0.80 to 1.25). The test of interaction on the basis of CYP2C19 genotype status was statistically significant (p = 0.013), suggesting that CYP2C19 genotype modified the effect. An additional 4 observational studies were found, and adding them to the analysis provided the same conclusions (p value of the test of interaction 0.001).The effect of ticagrelor or prasugrel compared with clopidogrel in reducing ischemic events in patients with CAD who predominantly undergo PCI is based primarily on the presence of CYP2C19 loss-of-function carrier status. These results support genetic testing prior to prescribing P2Y

Extracorporeal membrane oxygenation (ECMO) support is indicated for the management of patients with cardiogenic shock or refractory cardiac arrest in the cardiac catheterization laboratory. The aim of this study was to review the outcomes of patients initiated on ECMO support in the cardiac catheterization laboratory.We performed a retrospective analysis of adult patients (18 years old) initiated on ECMO support in the cardiac catheterization laboratory from 2010-2017. Baseline demographics, clinical characteristics, procedural details, and indication for ECMO support were reviewed. The outcomes assessed included 30-day mortality, blood product transfusion, vascular injury, prolonged respiratory failure, stroke, ischemic bowel, renal failure requiring hemodialysis, and compartment syndrome.Between January 1, 2010 and December 31, 2017, a total of 25 patients were cannulated for ECMO in the cardiac catheterization laboratory. The mean age was 61 years and 56% of patients were men. Cardiac arrest was the most frequent indication for ECMO support (64%), followed by cardiogenic shock (28%). The 30-day mortality rate was 40%. The most frequent complications associated with ECMO were the need for vascular surgery (52%) and renal failure requiring hemodialysis (36%). The univariate predictors of 30-day mortality were age (P=.02; unit odds ratio [OR], 1.08; 95% confidence interval [CI], 1.01-1.15), history of tobacco use (P=.04; OR, 6; 95% CI, 1.01-35.91), and Apache IV score (P=.02; unit OR, 1.02; 95% CI, 1.01-1.09).ECMO should be considered early during the resuscitation attempts of selected patients with ongoing cardiopulmonary resuscitation or refractory cardiogenic shock in the cardiac catheterization laboratory.

Background The extent of coronary disease affects clinical outcomes and may predict the effectiveness of coronary revascularization with either coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI). The SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score quantifies the extent of coronary disease. Objectives This study sought to determine whether SYNTAX scores predicted outcomes and the effectiveness of coronary revascularization compared with medical therapy in the BARI-2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) trial. Methods Baseline SYNTAX scores were retrospectively calculated for BARI-2D patients without prior revascularization (N = 1,550) by angiographic laboratory investigators masked to patient characteristics and outcomes. The primary outcome was major cardiovascular events (a composite of death, myocardial infarction, and stroke) over 5 years. Results A mid/high SYNTAX score (≥23) was associated with a higher risk of major cardiovascular events (hazard ratio: 1.36, confidence interval: 1.07 to 1.75, p = 0.01). Patients in the CABG stratum had significantly higher SYNTAX scores: 36% had mid/high SYNTAX scores compared with 13% in the PCI stratum (p Conclusions Among patients with diabetes and stable ischemic heart disease, higher SYNTAX scores predict higher rates of major cardiovascular events and were associated with more favorable outcomes of revascularization compared with medical therapy among patients suitable for CABG. (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes; NCT00006305)

Introduction: Transcatheter mitral valve replacement (TMVR) using aortic transcatheter heart valves (THV) is developing as an alternative to surgery for patients with severely degenerated mitral valve (MV) bioprostheses. Retrospective self-reported registries have collected outcomes on these TMVR procedures in the STS/ACC Transcatheter Valve Therapy Registry and in the Valve-in-Valve International Database. Most reported TMVR procedures for failed surgical bioprostheses have been performed using a transapical access approach. A prospective comprehensive evaluation of mitral Valve-in-Valve (VIV) outcomes, including transseptal access has not previously been conducted. Objectives: To evaluate in-hospital and 30-day clinical outcomes of transseptal mitral VIV with SAPIEN 3 THV in patients with very high surgical risk. Methods: Prospective enrollment of very high surgical risk patients with symptomatic severely degenerated MV surgical bioprostheses in 30 patients at 15 sites in the U.S. Candidates were assessed by a case review committee prior to approval. Baseline qualifying echocardiograms and cardiac CT studies were analyzed by independent core labs. Echocardiograms, cardiac CT studies and neurology evaluations were also performed after mitral VIV procedures. Clinical events were adjudicated by a clinical events committee and safety was monitored by a data safety monitoring board. Results: 26 patients have been enrolled between July 2016 and June 2017. Mean age was 83 years, 62% female, mean STS score was 10% and 62% were in New York Heart Association class III or IV. Transseptal access was used in all procedures. Technical success was achieved in all patients and there was no in-hospital mortality. There was no 30-day cardiovascular mortality and 4% (1 patient) 30-day all-cause mortality (1 patient died of asphyxia on day 29 after choking on pills at home), which was lower than the 30-day mortality in the TVT registry (9%). Detailed procedural, in-hospital and 30-day outcomes will be presented on the complete cohort of 30 patients. Conclusions: In patients without surgical alternatives, transseptal mitral ViV procedures in failed surgical bioprostheses are associated with high technical and procedural success and low 30-day mortality.

This study sought to evaluate the outcomes of the early experience of transcatheter mitral valve replacement (TMVR) with balloon-expandable valves in patients with severe mitral annular calcification (MAC) and reports the first large series from a multicenter global registry.The risk of surgical mitral valve replacement in patients with severe MAC is high. There are isolated reports of successful TMVR with balloon-expandable valves in this patient population.We performed a multicenter retrospective review of clinical outcomes of patients with severe MAC undergoing TMVR.From September 2012 to July of 2015, 64 patients in 32 centers underwent TMVR with compassionate use of balloon-expandable valves. Mean age was 73 ± 13 years, 66% were female, and mean Society of Thoracic Surgeons score was 14.4 ± 9.5%. The mean mitral gradient was 11.45 ± 4.4 mm Hg and the mean mitral area was 1.18 ± 0.5 cm(2). SAPIEN valves (Edwards Lifesciences, Irvine, California) were used in 7.8%, SAPIEN XT in 59.4%, SAPIEN 3 in 28.1%, and Inovare (Braile Biomedica, Brazil) in 4.7%. Access was transatrial in 15.6%, transapical in 43.8%, and transseptal in 40.6%. Technical success according to Mitral Valve Academic Research Consortium criteria was achieved in 46 (72%) patients, primarily limited by the need for a second valve in 11 (17.2%). Six (9.3%) had left ventricular tract obstruction with hemodynamic compromise. Mean mitral gradient post-procedure was 4 ± 2.2 mm Hg, paravalvular regurgitation was mild or absent in all. Thirty-day all-cause mortality was 29.7% (cardiovascular = 12.5% and noncardiac = 17.2%); 84% of the survivors with follow-up data available were in New York Heart Association functional class I or II at 30 days (n = 25).TMVR with balloon-expandable valves in patients with severe MAC is feasible but may be associated with significant adverse events. This strategy might be an alternative for selected high-risk patients with limited treatment options.

To compare left ventricular (LV) systolic and diastolic function in patients with apical ballooning syndrome (ABS) and those with acute myocardial infarction (AMI) using 2-dimensional Doppler echocardiography and strain rate imaging (SRI).We prospectively enrolled patients with newly diagnosed AMI and ABS who had akinetic apical walls. Both 2-dimensional Doppler echocardiography and SRI were performed on hospital day 1 or within 24 hours of primary percutaneous coronary intervention.Twenty-four patients with AMI and 13 patients with ABS (mean +/- SD age, 63+/-15 vs 73+/-12 years; P=.03) were prospectively enrolled in the study from October 3, 2005 through July 12, 2006. The mean +/- SD LV end-diastolic volume was larger (58.1+/-9.1 vs 45.2+/-10.6 mL/m(2); P.001) and the mean +/- SD LV ejection fraction was lower (35%+/-6% vs 43%+/-9%; P=.006) in patients with ABS compared with patients with AMI. The early diastolic mitral annular velocity was similar (0.06+/-0.02 vs 0.06+/-0.02 m/s; P=.85) in both groups, but the ratio of early diastolic mitral valve inflow velocity to early diastolic mitral annulus velocity was higher in patients with AMI than in patients with ABS (16.3+/-6.9 vs 12.2+/-3.2; P=.05). The systolic strain rate was decreased at the apex in both groups (P=.98). Both the early diastolic strain rate of the apex (0.64+/-0.24 vs 0.48+/-0.30 s(-1); P=.04) and the postsystolic shortening index of the apex (61%+/-15% vs 45%+/-23%; P=.006) were higher in the patients with ABS than in those with AMI. However, early diastolic SR was higher in the akinetic apical walls of patients with AMI with recovery than those with no recovery (0.64+/-0.35 vs 0.43+/-0.25 s(-1); P=.04) and was similar between akinetic apical walls of patients with AMI with recovery and the akinetic apical walls of ABS.Compared with patients with AMI, those with ABS showed the functional paradox of worse initial LV systolic function with larger LV size but better LV diastolic function. The early systolic strain rate and postsystolic shortening were greater in patients with ABS than in those with AMI; hence, these measurements can be helpful in distinguishing ABS from AMI and in detecting myocardial viability.

Our aim was to examine the prognostic importance of hemorrhagic and ischemic complications after percutaneous coronary intervention (PCI) in unselected patients.In randomized trials of PCI, major bleeding and periprocedural myocardial infarction (pMI) have been associated with increased mortality. Whether similar associations exist among un-selected PCI patients is unknown.We used data from the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) registry-a multicenter registry of unselected patients undergoing PCI-to examine the association between both in-hospital bleeding and pMI and 1-year mortality. Cardiac enzyme levels were assessed in all patients, and pMI was defined as a peak creatine kinase-MB valueor=3x the upper limit of normal. Post-PCI bleeding was classified by Thrombolysis In Myocardial Infarction criteria.After excluding patients with elevated pre-PCI creatine kinase-MB values and ST-segment elevation myocardial infarction at presentation (n = 1,626), a total of 5,961 patients were available for evaluation. Rates of post-PCI bleeding and pMI were 3.0% and 7.1%, respectively; 1-year all-cause mortality was 2.8%. After multivariable adjustment, both post-PCI bleeding (adjusted hazard ratio [HR]: 3.83, 95% confidence interval: 2.48 to 5.90, p0.001) and pMI (adjusted HR: 1.84, 95% confidence interval: 1.17 to 2.89, p = 0.009) were independently associated with 1-year mortality. Time period-specific analyses demonstrated that the adjusted HR for bleeding was similar for 30-day mortality and mortality between 1 month and 1 year, while the adjusted HR for pMI was greater for 30-day mortality as compared with mortality between 1 month and 1 year.Among unselected PCI patients, both post-PCI bleeding and pMI are independently associated with increased 1-year mortality. Continued efforts to reduce these complications after PCI are warranted.

Endovascular therapy is emerging as a minimally invasive therapy in the treatment of high-risk patients with abdominal aortic aneurysms. We report on an 81-year-old male who developed a large distal anastomotic pseudoaneurysm after undergoing surgical repair of an abdominal aortic aneurysm. The pseudoaneurysm was successfully treated by embolization utilizing a 15 mm Amplatzer(R) septal occluder device.

Determination of a transvalvular pressure gradient for measurement of aortic valve area (AVA) by hemodynamic cardiac catheterization usually requires 2 catheters and 2 arterial access sites. We assessed the feasibility of using a single arterial puncture and a 0.014 inch pressure wire for evaluation of aortic stenosis.Eighteen patients (mean age, 76 years; 10 men) underwent hemodynamic catheterization for assessment of AVA. Cardiac output was determined by thermodilution (using a pulmonary artery catheter), and the transvalvular pressure gradient was obtained from simultaneous pressure recordings (using a pressure wire to measure left ventricular pressure and a 5 Fr catheter to measure ascending aortic pressure).This novel technique was technically feasible in all patients. Calibration of the pressure wire with the pressure of the fluid-filled catheter was possible and accurate in the left ventricle and aorta. The method required 36.4 +/- 9.6 minutes from injection of a local anesthetic to completion of AVA measurement; 53.3 +/- 18.6 minutes were required to finish all catheterization procedures, including coronary angiography. Measurements of AVA (mean, 1.01 +/- 0.43 cm2) and pressure gradients (mean, 27.5 +/- 10.5 mmHg) taken by a pressure wire were similar to measurements taken by Doppler echocardiography (1.07 +/- 0.58 cm2 and 32.9 +/- 12.1 mmHg, respectively); the correlation was significant (r = 0.856; p0.001, and r = 0.741; p0.001, respectively).Our findings suggest that a single arterial approach using a pressure wire is feasible, safe, accurate and rapid for the invasive assessment of aortic stenosis.

Transcatheter aortic valve replacement (TAVR) has emerged as the treatment of choice for many inoperable and high risk patients with aortic stenosis. In patients without appropriate transfemoral (TF) access, transapical (TA) TAVR has been shown to be an appropriate alternative to surgery. Little is