Comparison of permanent pacemaker implantation rate after first and second generation of transcatheter aortic valve implantation-A retrospective cohort study.

OBJECTIVES: This study aimed to compare permanent pacemaker implantation (PPMI) rates among patients undergoing Trans-catheter Aortic Valve Implantation (TAVI) with first generation (G1) versus second generation (G2) valves and the impact of PPMI on long-term mortality. BACKGROUND: PPMI is a known adverse event after TAVI. Recently, two novel iterations of valve designs of both the balloon expandable valves (BEV) and self-expanding valves (SEV) were introduced as a second generation valves. METHODS: All patients included in the Israeli multicenter TAVI registry were grouped according to valve type (BEV vs. SEV) and generation (G1 vs. G2). A comparison was made for clinical and outcome indices of patients undergoing TAVI with G1 and G2 in each of the valve systems. RESULTS: A total of 1377 patients were included. The incidence of PPMI did not differ between G1-BEV versus G2-BEV (15.3% vs. 17.4%; p = 0.598) nor between G1-SEV versus G2-SEV (23.4% vs. 20.3%; p = 0.302). Depth of implantation and complete right bundle branch block were independently associated with PPMI post-TAVI in both valve systems. PPMI was not associated with an increased risk for 2-year mortality. CONCLUSIONS: The incidence of PPMI remains a relevant adverse event post-TAVI even when the newer generation valves are used. Since the predictors for PPMI are well established, a standardized approach for the management of conduction disorders is much needed.

Association of Polycythemia with Outcomes of Acute Coronary Syndrome.

BACKGROUND: Polycythemia has not been extensively studied for its impact on acute coronary syndrome (ACS) outcomes. A previous study reported only 30-day outcomes to be worse in these patients. METHODS: Data from the ACS Israeli survey between 2000 and 2018 were utilized to compare between 3 groups of patients with ACS: anemic group (hemoglobin <12 g/dL for women and <12.5 g/dL for men), normal hemoglobin group, and polycythemic group (>16 g/dL and >16.5 g/dL, respectively). Measured outcomes included 30-day major adverse cardiac events (MACE comprising all-cause mortality, recurrent ACS, need for urgent revascularization, and stroke) and 1- and 5-year all-cause mortality. RESULTS: Of 14,746 ACS patients, 10,752 (72.9%) had normal hemoglobin levels, 3,492 (23.7%) were anemic, and 502 (3.4%) were polycythemic. In comparison with normal and anemic patients, polycythemic patients were younger (55.9 ± 10.5 vs. 61.9 ± 12.4 and 71.1 ± 12.2 for anemic, respectively, p < 0.001 for both), more frequently men (93.8% vs. 81.3% and 63.1%, respectively, p < 0.001), and less likely diabetic or hypertensive. Upon adjustment to baseline characteristics, compared with normal hemoglobin, polycythemia was not independently associated with 30-day MACE or 1-year mortality, but it was independently associated with higher risk for 5-year mortality (HR 1.76, 95% CI: 1.19-2.59, p = 0.005). Similar results were observed after propensity score matching. CONCLUSIONS: Although younger and with fewer comorbidities, polycythemic ACS patients are at increased risk for long-term all-cause mortality. Further study of this association is warranted to understand the causes and possibly to improve the outcomes of these patients.

Shifting from vitamin K antagonists to non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation: predictors, patterns and temporal trends.

BACKGROUND: Non-Vitamin K antagonist oral anticoagulants (NOACs) emerged as an alternative with comparable or superior efficacy and safety to vitamin K antagonists (VKAs) for stroke prevention in patients with non-valvular atrial fibrillation (AF). OBJECTIVES: The aim of the current study was to investigate the patterns, predictors, timelines and temporal trends of shifting from VKAs to NOACs. METHODS: In this retrospective observational study, the computerized database of a large healthcare provider in Israel, Maccabi Healthcare Services, was searched to identify patients with AF for whom either a VKA or NOAC was prescribed between 2012 and 2015. Time from diagnosis to therapy initiation and to shifting between therapies was evaluated. RESULTS: Out of 6987 eligible AF incident patients, 2338 (33.4%) initiated treatment with a VKA and 2221 (31.7%) with a NOAC. In addition, 5259 prevalent patients were analyzed. During the study period, NOAC prescriptions proportion among the newly diagnosed cases increased from 32 to 68.4% (p for trend <  0.001). The median time from diagnosis to first dispensing was greater in NOAC than VKA and decreased among patients treated with NOAC during the study period (2012: 1.9 and 0.3 months, 2015: 0.7 and 0.2 months, respectively). During follow-up, 3737 (49%) patients (54.3% and 47.1% of the incident and prevalent cases, respectively), shifted from a VKA to a NOAC, after a median of 22 months and 39 months in the incident and prevalent cases, respectively, decreasing throughout the study period. Female gender, younger age, southern district, higher CHADS2 and CHA2DS2-VASC score, non-smoking, and treatment with antiplatelets were associated with a greater likelihood for therapy shift. Shifting from a NOAC to a VKA decreased over time from 8 to 4.5% in 2012 to 0.5% and 0.7% in 2015 in the incident and prevalent groups, p <  0.001 respectively. CONCLUSIONS: Shifting from VKA to NOAC occurred in 50% of the cases, more frequently among incident cases, and younger patients with greater stroke risk. Shifting from a NOAC to a VKA was much less frequent, yet it occurred more often in incident cases and decreased over time. A socially and economically sensitive program to optimize the initiation of OAC therapy upon diagnosis is warranted.

Return to training in the COVID-19 era: The physiological effects of face masks during exercise.

COVID-19 outbreak has a profound impact on almost every aspect of life. Universal masking is recommended as a means of source control. Routinely exercising in a safe environment is an important strategy for healthy living during this crisis. As sports clubs and public spaces may serve a source of viral transmission, masking may become an integral part of physical activity. This study aimed to assess the physiological effects of wearing surgical masks and N95 respirators during short-term strenuous workout. This was a multiple cross-over trial of healthy volunteers. Using a standard cycle ergometry ramp protocol, each subject performed a maximal exercise test without a mask, with a surgical mask, and with an N95 respirator. Physiological parameters and time to exhaustion were compared. Each subject served his own control. Sixteen male volunteers (mean age and BMI of 34 ± 4 years and 28.72 ± 3.78 kg/m2 , respectively) completed the protocol. Heart rate, respiratory rate, blood pressure, oxygen saturation, and time to exhaustion did not differ significantly. Exercising with N95 mask was associated with a significant increase in end-tidal carbon dioxide (EtCO2 ) levels. The differences were more prominent as the load increased, reaching 8 mm Hg at exhaustion (none vs N95, P = .001). In conclusion, in healthy subjects, short-term moderate-strenuous aerobic physical activity with a mask is feasible, safe, and associated with only minor changes in physiological parameters, particularly a mild increase in EtCO2 . Subjects suffering from lung diseases should have a cautious evaluation before attempting physical activity with any mask.

[HYPERTENSION AMONG HEMODIALYSIS PATIENTS, NOT NECESSARILY HYPERVOLEMIA].

BACKGROUND: Hypertension in dialysis patients is common. In daily practice, it is not always clear whether adjustment of dry weight or vasodilatory medication should be administered and treatment strategy is often based on clinical impression. We used a whole-body bio-impedance based, non-invasive, hemodynamics monitoring technology to acquire hemodynamic data in order to evaluate the incidence and causes of hypertension in dialysis patients. METHODS: Novel noninvasive impedance based technique was used to collect hemodynamic data from patients undergoing chronic hemodialysis in four different dialysis units. Patients were defined as having hypertension if their predialysis systolic or diastolic BP results were >140mmHg or >90 respectively and as hypervolemic if their total body water (TBW) was greater than normal according to the Kushner formula+1SD. Vasoconstriction was defined as total peripheral resistance index (TPRI) greater than 3000 dyn*sec/cm5*m2. RESULTS: Of 144 hemodialysis patients, 81 (56%) were male; mean age was 67.3±12.1 years and 67 (47%) had hypertension. Among the hypertensive patients, only 18(27%) met hypervolemia criteria and thirty (45%) met vasoconstriction criteria (mean TPRI of 4474±1592dyn*sec/cm5*m2). Patients with hypertension due to vasoconstriction had higher vintage (50±45 vs 20±8 months 0=0.018), lower heart rate (71±11 vs 79±11 BPM p=0.002), lower stroke index (28±7 vs 44±8ml/m2 p<0.001) and cardiac index (2.1±0.5 vs 3.5±0.6 p=0<0.001) compared to patients without vasoconstriction. CONCLUSIONS: Vasoconstriction was the main etiology for pre-dialysis hypertension in chronic hemodialysis patients. This calls for individualized, hemodynamic-based therapeutic intervention.

Non-invasive hemodynamic profiling of patients undergoing hemodialysis - a multicenter observational cohort study.

BACKGROUND: Intradialytic blood pressure (BP) measurement is currently the main parameter used for monitoring hemodynamics during hemodialysis (HD). Since BP is dependent on cardiac output and total peripheral resistance, knowledge of these parameters throughout the HD treatment would potentially be valuable. METHODS: The use of a novel non-invasive monitoring system for profiling hemodynamic response patterns during HD was explored: a whole-body bio-impedance system was used to assess cardiac index (CI), total peripheral resistance index (TPRI), cardiac power index (CPI) among other parameters in chronic HD patients from 4 medical centers. Measurements were made pre, during and post dialysis. Patients were grouped into 5 hemodynamic profiles based on their main hemodynamic response during dialysis i.e. high TPRI; high CPI; low CPI; low TPRI and those with normal hemodynamics. Comparisons were made between the groups for baseline characteristics and 1-year mortality. RESULTS: In 144 patients with mean age of 67.3 ± 12.1 years pre-dialysis hemodynamic measurements were within normal limits in 35.4% but only 6.9% overall remained hemodynamically stable during dialysis. Intradialytic BP decreased in 65 (45.1%) in whom, low CPI (47 (72.3%)) and low TPRI (18 (27.7%) were recorded. At 1-year follow-up, mortality rates were highest in patients with low CPI (23.4%) and low TPRI (22.2%). CONCLUSIONS: Non-invasive assessment of patients' response to HD provides relevant hemodynamic information that exceeds that provided by currently used BP measurements. Use of these online analyses could potentially improve the safety and performance standards of dialysis by guiding appropriate interventions, particularly in responding to hypertension and hypotension.

Does direct stenting with drug-eluting stents improve outcome? A meta-analysis of 10,900 patients.

OBJECTIVES: The aim of this study is to summarize the outcomes of patients undergoing direct stenting (DS) with drug-eluting stents (DES) compared to those who underwent balloon predilatation. BACKGROUND: DS has been associated with improved outcomes in the bare-metal stent era. Although DS with DES implantation has been increasingly adopted in clinical practice, its safety and effectiveness remain controversial. METHODS: The search criteria identified 546 studies in the Medline/PubMed, Cochrane, and EMBASE databases from 2001 to July 2014. From these, seven studies totaling 10,900 patients were selected. Summarized estimates [odds ratio (OR) and 95% confidence intervals] were obtained using a random-effects model. The primary outcomes were a composite of major adverse cardiac events (MACE), including all-cause death, myocardial infarction (MI), and repeat revascularization. The secondary outcomes included a composite of death and MI and the rates of target lesion revascularization (TLR). RESULTS: Overall, 4101 (38%) and 6799 (62%) patients underwent DS with DES and balloon pre-dilatation, respectively. DS with DES reduced the likelihood of MACE (OR: 0.81 [0.71-0.93]). Additionally, DS with DES was associated with reduced rates of death/MI (OR: 0.76 [0.62-0.92]), and TLR (OR: 0.66 [0.44-0.98]). CONCLUSIONS: DS with DES is safe and may be associated with better outcomes in selected patients. © 2016 Wiley Periodicals, Inc.

Routine Laboratory Indices as Predictor of Neurological Recovery in Post-Resuscitation Syndrome Patients Treated with Therapeutic Hypothermia.

BACKGROUND: Hypothermia is associated with improved outcome in selected survivors of cardiac arrest but no single metric enables proper prediction of neurological outcome. OBJECTIVES: To explored the association between routine laboratory indices of patients treated by hypothermia for cardiac arrest and their neurological outcome. METHODS: We retrospectively collected data from survivors of cardiac arrest treated with hypothermia for 24 hours and grouped them according to their neurological outcome to either "poor" or "favorable". Routine laboratory indices were collected at constant time intervals up to one week of admission. A comparison between the laboratory values in both groups was performed. RESULTS: Between May 2008 to November 2011, 41 consecutive patients with a mean age of 54.3 ± 16.7 years were included in this study. No significant correlation was found between routine laboratory indices and the neurological outcome. The temporal trend of decay in the serum glucose values and the ratio of polymorphonuclears to white blood cells during the first 72 hours after admission was steeper in the favorable outcome group (P for trend < 0.05). CONCLUSIONS: No single routine laboratory index was associated with neurological outcome of survivors of cardiac arrest treated with hypothermia. The temporal trends in both serum glucose and polymorphonuclear ratio signal a more intense inflammatory response associated with poor outcome.

Impact of baseline mitral regurgitation on short- and long-term outcomes following transcatheter aortic valve replacement.

BACKGROUND: The prevalence of concomitant significant mitral regurgitation (MR) in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) ranges from 2% to 33%. The impact of significant MR on post-TAVR outcomes remains controversial. METHODS: The data from a cohort of patients with symptomatic severe AS undergoing TAVR at out institution were retrospectively analyzed. The last transthoracic echocardiogram (TTE) before the index TAVR procedure was selected as the baseline assessment of the degree of MR. The total study cohort (N = 589) was divided into 2 groups: significant ≥moderate MR (n = 68) versus nonsignificant

Does the disparity in baseline characteristics of patients undergoing transcatheter aortic valve replacement with 23 mm vs. 26 mm valves impact clinical outcome?

OBJECTIVES: We sought to identify if baseline characteristic differences in patients who receive a 23 mm vs. 26 mm valve impact clinical outcomes. BACKGROUND: Transcatheter aortic valve replacement (TAVR) is currently an approved therapy for patients with severe aortic stenosis who are considered inoperable or are at high risk. METHODS: We retrospectively examined baseline characteristics and outcomes of patients receiving a 23 mm (n = 132) vs. 26 mm valve (n = 81) via the transfemoral approach. RESULTS: Gender (P < 0.01), previous coronary artery bypass surgery (P < 0.01), history of atrial fibrillation (P = 0.04), and mean Society of Thoracic Surgeons (STS) score (P < 0.01) were significantly different between groups. There were no significant differences in the rates of minor/major vascular complications (2.2 vs. 3.7%, P = 0.68 and 13.0 vs. 12.3%, P = 0.89, respectively). Bleeding complications were also comparable (major bleed 2.3 vs. 1%, P >0.99, minor bleed 19.0 vs. 22.0%, P = 0.67 and life threatening bleed 7.0 vs. 5.0%, P = 0.77). In-hospital death (6.0 vs. 5.0%, P >0.99), 30-day all-cause death (7.6 vs. 6.2%, P = 0.69), and all-cause death at 1 year (17.4 vs. 25.9%, P = 0.13) were also similar between groups. Gender, valve size, previous coronary bypass surgery and atrial fibrillation were not independently associated with mortality; however, on multivariate analysis STS score was (HR 1.11; 95% CI 1.02-1.19; P = 0.01). CONCLUSION: Patients undergoing TAVR with 23 and 26 mm valves have similar clinical outcomes despite significant differences in baseline characteristics. © 2015 Wiley Periodicals, Inc.

Body mass index association with survival in severe aortic stenosis patients undergoing transcatheter aortic valve replacement.

BACKGROUND: Conflicting results have been reported regarding impact of body mass index (BMI) on outcome of transcatheter aortic valve replacement (TAVR) patients. This study evaluates the impact of BMI on 1 year mortality in patients undergoing TAVR via the transfemoral (TF) access. METHODS: Aortic stenosis (AS) patients undergoing TAVR via a TF access between May 2007 and December 2014 were categorized to 4 groups by BMI: low (<20), normal (20-24.9), overweight (25-30), and obese (>30). Baseline parameters were compared, and multivariate Cox proportional hazard regression models were generated to assess outcome differences. RESULTS: Among 491 severe AS TAVR patients, 43 had low BMI, 148 had normal BMI, 162 were overweight, and 138 were obese. Obese patients were younger with lower Society of Thoracic Surgeons scores and higher rates of preserved ejection fraction and diabetes. There was a higher rate of women in the BMI extremes. Aortic valve area was higher among obese patients; however, the indexed area was inversely correlated with BMI. Vascular complications and transfusions were more common in the low-BMI group, while acute kidney injury was more common in obese patients. All-cause mortality at 1 year was higher in the low-BMI group (log-rank p = 0.003) with no significant difference among normal and above-normal BMI patients. In a multivariate model, BMI <20 kg/m(2) was an independent predictor of mortality (HR = 2.45, p = 0.01). CONCLUSIONS: BMI <20 kg/m(2) should be considered a frailty marker during the screening process of severe AS TAVR patients as it is associated with higher mortality, while obesity confers similar mortality risk as normal weight. © 2015 Wiley Periodicals, Inc.

Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial: Technical performance.

OBJECTIVES: To assess technical performance learning curves of teams performing transfemoral transcatheter aortic valve replacement (TF-TAVR). BACKGROUND: TF-TAVR is a new procedure for treating severe aortic stenosis. The number of cases required for procedural efficiency is unknown. METHODS: In the PARTNER-I trial, 1,521 patients underwent TF-TAVR from 4/2007-2/2012. Learning curve analysis of technical performance metrics was performed using institution-specific patient sequence number, interval between procedures, and institutional trial entry date. Learning curve characteristics were assessed using semi-parametric and parametric mixed-effects models. RESULTS: As patient sequence number increased, average procedure time decreased from 154 to 85 minutes (P < 0.0001), and fluoroscopy time from 28 to 20 minutes (P < 0.0001). Procedure time plateaued at an average of 83 minutes (range 52-140). Procedure time plateau was dynamic during the course of the trial, averaging 25 cases (range 21-52) by its end. The later institutions enrolled in the trial, the shorter the initial procedure time. During the trial, percutaneous rather than surgical access increased from 7.9% to 69%. CONCLUSIONS: Technical performance learning curves exist for TF-TAVR; procedural efficiency increased with experience, with concomitant decreases in radiation and contrast media exposure. The number of cases needed to achieve efficiency decreased progressively, with optimal procedural performance reached after approximately 25 cases for late-entering institutions. Knowledge and experience accumulated by early TF-TAVR institutions were disseminated, shortening the learning curve of late-entering institutions. Technological advances resulting from learning during the trial moved the field from initial conservative surgical cut-down to percutaneous access for most patients. © 2015 Wiley Periodicals, Inc.

Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial: Success and safety.

OBJECTIVES: To identify number of cases needed to maximize device success and minimize adverse events after transfemoral transcatheter aortic valve replacement (TF-TAVR), and determine if adverse events were linked to the technical performance learning curve. BACKGROUND: TF-TAVR is a complex procedure with an incompletely characterized learning curve for clinical outcomes. METHODS: From 4/2007-2/2012, 1521 patients underwent TF-TAVR in the PARTNER-I trial. Outcomes learning curves were defined as number of cases needed to reach a plateau for device success, adverse events, and post-procedure length of stay. Institutional variation was accounted for by mixed-model non-linear techniques, which were also used to identify contribution of the procedure time learning curve to 30-day major adverse events and length of stay. RESULTS: Eighty percent device success was achieved after 22 cases; major vascular complications fell below 5% after 70 cases and major bleeding below 10% after 25 cases. It took an average of 28 cases to achieve a consistent low risk of 30-day major adverse events, but institutions entering in the middle of the trial achieved it after about 26. The most significant correlate of 30-day major adverse events and post-procedure length of stay was procedure time (P < 0.0001). However, this association was related to patient and unmeasured variables, not the procedure time learning curve (P = 0.6). CONCLUSIONS: By end of trial, a consistent low risk of adverse events was achieved after ∼26 cases. However, these improved results were due to change in patient risk profile; outcomes were not linked to the technical performance learning curve. © 2015 Wiley Periodicals, Inc.

The choice of arterial access for percutaneous coronary intervention and its impact on outcome: An expert opinion perspective.

The prevention of major bleeding during percutaneous coronary intervention is one of the most widely discussed and often controversial topics within interventional cardiology. The choice of arterial access should be considered a mechanism for bleeding avoidance, and various strategies have been proposed to prevent or lower major bleeding and vascular complications with varying levels of strength. Herein, we review the current literature on arterial access as a bleeding avoidance strategy during percutaneous coronary intervention and its impact on outcome and provide a consensus opinion based on the strength of the evidence supporting various techniques.

Predictors and clinical implications of atrial fibrillation in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation.

OBJECTIVES: To assess the prevalence at baseline, postprocedural incidence, and clinical impact of atrial fibrillation (AF) on consecutive patients undergoing transcatheter aortic valve implantation (TAVI). BACKGROUND: AF in patients with aortic stenosis (AS) is an independent risk factor for adverse outcome. Despite the evidence for high AF prevalence and the increased risk in surgical series, there are limited data with regard to AF and its impact on outcome after TAVI. METHODS: Consecutive patients with symptomatic, severe AS were analyzed and categorized according to prevalence of AF on initial admission (baseline AF) and according to the development of new AF postprocedure (postprocedure AF). A total of 371 patients were included in the analysis; of them, 143 (39%) had AF at baseline. RESULTS: No difference in procedural and hospital outcome was found between groups; however, baseline AF patients did have higher 1-year mortality (28.8 vs. 18%, P = 0.01). Of the patients with no baseline AF, 46 patients (20%) developed new, postprocedural AF during their hospital stay. Inhospital death was twice as frequent in patients with new, postprocedure AF, however, this difference did not reach statistical significance (13 vs. 6.7%, P = 0.22). Procedure hemodynamic instability (OR 9.3; 95% CI 1.5-59), and transapical access (OR 4.96, 95% CI 1.9-13.2) were independent predictors for development of new AF. CONCLUSIONS: Baseline and postprocedure AF are common in AS patients undergoing TAVI. However, only postprocedure AF is associated with a prolonged and more complicated hospital course. AF is associated with poor long-term, but not short-term, mortality.

Safety and long-term outcomes after percutaneous coronary intervention in patients with human immunodeficiency virus.

OBJECTIVE: This study aims to report the long-term outcomes after percutaneous coronary intervention (PCI) in human immunodeficiency virus (HIV+) patients. BACKGROUND: Sparse data exists regarding the risk of patients with HIV who undergo PCI. METHODS: Using a case-control design, we compared baseline characteristics, procedure-related outcomes, in-hospital, and 2-year clinical outcomes of 112 consecutive HIV+ patients versus 112 HIV- controls matched for age, gender, and diabetes mellitus who underwent PCI from April 2003 to September 2011. RESULTS: Baseline characteristics were generally comparable, save for more African Americans and history of chronic renal insufficiency in the HIV+ vs. HIV- group (62.5% vs. 21.4%, P < 0.001) and (27.7% vs. 9.9%, P < 0.001). There was no correlation between CD4 nadir count and extent and diffuseness of coronary artery disease. The occurrence of major adverse cardiac events at 2 years was similar in both groups. Multivariable analysis for independent correlates of major adverse cardiac events at 2 years detected patients with a history of chronic renal insufficiency (OR: 2.44, 95% confidence interval: 1.02-5.83; P = 0.04) and acute myocardial infarction (OR: 2.92, 95% confidence interval: 1.39-6.15; P = 0.005) as correlates for outcome. Post-hoc analysis showed that drug-eluting stent (DES) use in the HIV+ group was beneficial. CONCLUSION: PCI in HIV+ patients is safe, with high procedural success rates, and produces similar outcomes to those seen in HIV- patients at 2 years. HIV+ patients should be treated with DES if possible.

Outcome comparison of African-American and Caucasian patients with severe aortic stenosis subjected to transcatheter aortic valve replacement: a single-center experience.

OBJECTIVE: This study aimed to report the outcomes of African Americans (AAs) in the US undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS). BACKGROUND: Compared to Caucasians, AAs are reported to have poorer outcomes from most cardiovascular diseases, including high complication rates after surgical aortic valve replacement. The outcomes of AAs undergoing TAVR are not well established. METHODS: Consecutive patients who underwent TAVR were included in this analysis. Patients' baseline characteristics, procedural data, in-hospital- and long-term outcomes were recorded and a comparison was performed between the AA and Caucasian cohorts. RESULTS: In a cohort of 469 consecutive patients, 51 (10.8%) were AA and 345 (74.5%) were Caucasian. The remaining patients (n = 73; 15.3%) self-reported their race as "unknown" or were from other races. Most baseline characteristics were similar between the two groups except for less men (33.3 vs. 50.1%; P = 0.016), a lower mean left ventricular ejection fraction (48.85 ± 16.35 vs. 53.24 ± 13.41%; P = 0.04) and lower rates of atrial fibrillation in AAs (15.7 vs.45.4%; P < 0.001). TAVR procedures in AAs were less frequently performed as part of a clinical trial (60.8 vs. 76.8%; P = 0.014). Most procedural and periprocedural outcome parameters were similar save for a higher rate of hemodynamic instability and postoperative need for intubation in AAs (10.4 vs. 2.5%; P = 0.018 and 29.4 vs. 16.9%; P = 0.03, respectively). This did not translate into a difference in mortality between AAs and Caucasians (30-day mortality 9.8 vs. 9.9%; P = 0.99; 1-year mortality 19.6 vs. 24.3%; P = 0.458, respectively). CONCLUSION: Unlike with other cardiovascular interventions, this study demonstrates that AA patients referred for TAVR shared similar risks and outcomes when compared to a Caucasian population.

Acquired thrombocytopenia after transcatheter aortic valve replacement: clinical correlates and association with outcomes.

AIMS: This study aimed to evaluate incidence and correlates for low platelet count after transcatheter aortic valve replacement (TAVR) and to determine a possible association between acquired thrombocytopenia and clinical outcomes. METHODS AND RESULTS: Patients undergoing TAVR from two medical centres were included in the study. They were stratified according to nadir platelet count post procedure: no/mild thrombocytopenia, ≥100 × 10(9)/L; moderate, 50-99 × 10(9)/L; and severe, <50 × 10(9)/L. A total of 488 patients composed of the study population (age 84.7 ± 7.5 years). At a median time of 2 days after TAVR, 176 patients (36.1%) developed significant thrombocytopenia: 149 (30.5%) moderate; 27 patients (5.5%) severe. Upon discharge, the vast majority of patients (90.2%) had no/mild thrombocytopenia. Nadir platelet count <50 × 10(9)/L was highly specific (96.3%), and a count <150 × 10(9)/L highly sensitive (91.2%), for predicting 30-day death (C-statistic 0.76). Patients with severe acquired thrombocytopenia had a significantly higher mortality rate at 1 year (66.7% for severe vs. 16.0% for no/mild vs. 20.1% for moderate; P < 0.001). In multivariate logistic regression, severe thrombocytopenia was independently associated with 1-year mortality (hazard ratio 3.44, CI: 1.02-11.6; P = 0.046). CONCLUSIONS: Acquired thrombocytopenia was common after TAVR and was mostly resolved at patient discharge. The severity of thrombocytopenia after TAVR could be used as an excellent, easily obtainable, marker for worse short- and long-term outcomes after the procedure.

[ONE YEAR FOLLOW-UP OF PATIENTS AFTER CARDIAC ARREST TREATED WITH THERAPEUTIC HYPOTHERMIA: PROSPECTIVE COHORT STUDY COMPARED WITH HISTORICAL CONTROL].

BACKGROUND: Mild therapeutic hypothermia has been shown to reduce mortality and neurological morbidity in post cardiac arrest survivors. These beneficial effects had initially been reported in retrospective studies and subsequently more evidence has been gathered by two cornerstone randomized control trials. All these studies focused on the acute outcome and the clinical status at the time of hospital discharge. The main goal of this study was to describe the long term effects of therapeutic hypothermia in this population. PATIENTS AND METHODS: A prospective cohort with a historical control group was used in this study. All consecutive patients eligible for therapeutic hypothermia after cardiac arrest were enrolled. These patients were compared to an historical control group of patients who had met the same criteria of treatment with therapeutic hypothermia, but were not treated since it was not yet available. Patients' records and clinical assessment at 1 week, one, six and twelve months follow-up were collected. RESULTS: In the present study 54 consecutive patients were recruited prospectively, treated with mild hypothermia and 41 patients served as the historical control group for a similar period of time. The cooling group was significantly younger than the control group, 54 ± 16.3 versus 61.1 ± 14.5 years (p < 0.04). Peripheral arterial embolism complication was more common in the hypothermia group. 11.1% versus 0% (p < 0.035). No other clinically meaningful differences were found. In this respect, the beneficial trend towards reduced neurological outcome and mortality was observed in favor of the cooling group, which was statistically significant at six months follow-up (p < 0.044). Beyond 6 months the differences did not reach statistical significance. CONCLUSION: In the current phase of the study, a tendency in favor of mild cooling was observed in the short and medium term outcomes in patients resuscitated after out of hospital cardiac arrest due to fatal arrhythmia. The current results indicate that in spite of high survival rates after the acute stage in the cooling group, the long term mortality rate in this group is still high.

Does baseline hematocrit influence the assays of on-treatment platelet reactivity to clopidogrel?

BACKGROUND: High on-treatment platelet reactivity (HTPR) has been shown to be associated with adverse cardiac events in patients undergoing percutaneous coronary intervention, but the effect of baseline hematologic parameters upon platelet reactivity remains controversial. OBJECTIVE: The present study aims to evaluate the impact of hematocrit on 2 different assay methods used to assess on-treatment platelet reactivity to clopidogrel. METHODS: We tested clopidogrel on-treatment platelet reactivity in 466 consecutive patients using VerifyNow P2Y12 (VN) and light transmission aggregometry (LTA) with adenosine diphosphate (ADP) 5 and 20 µM assays 6 to 24 hours after percutaneous coronary intervention. Patients were categorized into 4 groups according to baseline hematocrit. One-year major adverse cardiac events, including death, nonfatal myocardial infarction, and definite stent thrombosis, were collected. RESULTS: Lower hematocrit was associated with higher P2Y12 reaction unit (PRU) and a higher rate of HTPR (P < .001) as measured by VN assay. No differences were seen among the 4 groups in platelet reactivity measured by LTA using ADP 5 µM (P = .23) and ADP 20 µM (P = .21). In a multivariable logistic regression model, baseline hematocrit was independently associated with PRU ≥208 (odds ratio [OR] 0.92, 95% CI 0.86-0.97, P = .005) but had no correlation with LTA ADP 5 µM ≥46% (OR 1.0, 95% CI 0.95-1.06, P = .88) or LTA ADP 20 µM ≥59% (OR 1.03, 95% CI 0.97-1.09, P = .39). In a logistic regression model, the addition of VN assay results, hematocrit, and interaction between the hematocrit and assay results had shown a significant influence on the area under curve for prediction of 1-year major adverse cardiac events compared with baseline clinical variables only for PRU (0.63 vs 0.76, P = .006) but not with LTA (0.64 vs 0.74, P = .13). CONCLUSION: Baseline hematocrit has a differential influence on results of the ex vivo platelet functional assays. Lower baseline hematocrit was independently associated with HTPR by VN but not LTA. This may affect the interpretation of platelet function testing in patients with significant anemia.