High-risk Patient Profile Research Articles

Vascular Complications and Bleeding After Transfemoral TAVR With Surgical Versus Percutaneous Approach: A Contemporary Prospective Study

Background: Percutaneous (PC) access has become the first‐line strategy for transfemoral (TF) transcatheter aortic valve replacement (TAVR), but surgical cutdown (SC) may be required in selected and usually challenging cases. We aimed to compare the efficacy and safety of SC versus echo‐guided PC approach in TF TAVR.Methods: Between November 2019 and December 2020, all patients undergoing TF TAVR were included in a prospective study. The choice of PC or SC strategy was left at operators’ discretion, according to predictable access site difficulties. The primary endpoint included all vascular complications (VCs) and all bleeding at 1‐month follow‐up according to Valve Academic Research Consortium‐2 criteria.Results: Among 225 patients, 166 (73.8%) and 59 (26.2%) underwent PC or SC approach, respectively. Median age was 82 years, EuroSCORE 2 was higher (p = 0.02), and peripheral arterial disease (p < 0.001) was more common in the SC group. Femoral access was successful in 100% in the SC group vs 97.6% in the PC group (p = 0.2). The primary endpoint was reached in 32 patients (14.2%), 5 (8.4%) in the SC group and 27 (16.2%) in the PC group (p = 0.1) with low incidence of major VC in both groups (1.7% vs 3% in the SC and PC groups respectively, p = 0.6).Conclusion: Despite a higher risk profile of patients in the SC group, SC and PC approaches appear safe and effective in TF TAVR, with a high success rate. SC may be considered when vascular access is anticipated as complex, but this strategy might be confirmed in a randomized study.Trial Registration: ClinicalTrials.gov identifier: NCT03865043

Poster 313: More Severe Adverse Events are Associated with Worse Patient Reported Outcome Measures following Anterior Cruciate Ligament Reconstruction with and without Lateral Extra- articular Tenodesis Augmentation – Results from the Stability Randomized Trial

Objectives: Investigate how the severity of adverse events encountered during the follow up period of the Stability Study were associated with patient reported outcomes at two years post-operative. Methods: Stability is a pragmatic, multicenter, randomized clinical trial comparing single-bundle hamstring tendon ACLR with combined ACLR + LET. Patients aged 14-25 years with an ACL deficient knee were included (n = 618). Participants completed PROMs (KOOS, IKDC, ACL-QOL), and adverse events were documented pre-operatively and at 3, 6, 12 and 24 months postoperatively. Adverse events were categorized into four groups: none (no adverse event), minor medical (resolved spontaneously or with minimum medical management), minor surgical (event such as meniscus tear or stiffness that required surgical intervention but is not a graft rupture), contralateral ACL rupture, and graft rupture. A generalized linear model was used to compare mean PROM scores with the different levels of adverse events. Results: The rate of minor medical adverse events (11.2%), minor surgical adverse events (7.4%), and ipsilateral (7%) or contralateral (3%) ACL tears at 24 months post-operative were low considering the high-risk patient profile. There was no difference in the proportion of minor medical events, minor surgical events, or contralateral ACL ruptures between the ACLR only and ACLR + LET groups (p>0.05). The ACLR only group had a significantly higher rate of graft rupture (11 vs 4%, p<0.01). Increasing severity of adverse events were associated with lower PROM scores at 24 months post-operative. Patients who experienced any adverse event within the two-year follow up had significantly lower outcome scores than those with no events. When only adverse events in the first year post-operative were included, the influence of minor medical and minor surgical events was largely washed out suggesting the effect on outcomes may be due to recency rather than severity. However, graft tears and contralateral ACL tears within the first year led to significantly lower scores at two-years post-operative in all outcomes (p<0.01). Conclusions: Increasing severity of adverse events were associated with lower patient reported outcome measures at 2 years post-operative. Recent minor medical and minor surgical events worsened PROM scores, but this effect was largely eliminated within a year of the event. Patients who experience a graft rupture or contralateral ACL tear appear to have a significantly lower PROMs at 2 years post- operative, regardless of the time at which the tear occurs. Therefore, the benefit of the LET procedure reducing graft rupture outweighs the potential for less severe events such as hardware irritation/removal which will likely be less detrimental to patient-important outcomes.

No increase in adverse events with lateral extra-articular tenodesis augmentation of anterior cruciate ligament reconstruction – Results from the stability randomized trial

ObjectivesResults from the Stability Study suggest that adding a lateral extra-articular tenodesis (LET) to a hamstring tendon autograft reduces the rate of anterior cruciate ligament reconstruction (ACLR) failure in high-risk patients. The purpose of this study is to report adverse events over the 2-year follow-up period and compare groups (ACLR alone vs. ACLR + LET). MethodsStability is a randomized clinical trial comparing hamstring tendon ACLR with and without LET. Patients aged 14–25 years with an ACL deficient knee were included. Patients were followed and adverse events documented (type, actions taken, resolution) with visits at 3, 6, 12, and 24 months postoperatively. Adverse events were categorized as none, minor medical, minor surgical, contralateral ACL rupture, or graft rupture. Patient reported outcome measures (PROMs) collected at each visit included the Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee Score (IKDC), and ACL Quality of Life Questionnaire (ACL-QOL). ResultsIn total, 618 patients were randomized (mean age 18.9 years, 302 (49%) male). Forty-five patients (7%) suffered graft rupture; 34 (11%) in the ACLR group compared to 11 (4%) in the ACLR + LET group (RRR = 0.67, 95% CI 0.36 to 0.83, p < 0.001). There were no differences in effusion or infection rates between groups. The ACLR + LET group experienced an increased number of hardware removals (10 vs. 4). Overall, the rate of minor medical events (11%), minor surgical events (7%), and ipsilateral or contralateral ACL tears (10%) were low considering the high-risk patient profile. Increasing severity of adverse events was associated with lower PROMs at 24 months post-operative. Patients in the ACLR + LET group reported greater degree of pain at 3 months only. There were no clinically significant differences in range of motion between groups. ConclusionsThe addition of LET to hamstring tendon autograft ACLR in young patients at high risk of re-injury resulted in a statistically significant reduction in graft rupture. While the addition of LET may increase rates of hardware irritation, there was no significant increase in overall rates of minor medical adverse events, minor surgical events, or overall re-operation rates. The concerns regarding complications associated with a LET did not materialize in this study. Level of evidenceLevel I

Sternal wound infections after sternotomy: risk factors, prevention and management

A serious complication after cardiac surgery is sternal wound infection. Although incidence rates vary worldwide, this complication raises significant concern in a certain patient demographic. This article uses risk assessment strategies to identify a high-risk patient profile and draws parallels with positive predictors in the preoperative, intraoperative and postoperative setting. It describes the complexity of sternal wound infections and highlights guidelines on detection and treatment. The optimal goal of this article is to help minimise the incidence of sternal wound complications after sternotomy by discussing recommendations for preoperative, intraoperative and postoperative preventive measures.

SARS, MERS, COVID-19: Identification of Patients at a Higher Risk: A Narrative Review

The different presentations, comorbidities, and outcomes of COVID-19 highlight the importance of early identification and proper triage of patients. High-risk patients can be divided into patients with common comorbidities and patients with special categories. Common comorbidities include, but are not limited to, Cardiovascular Disease (CVD), Diabetes Mellitus (DM), immunosuppression, underlying respiratory disease, and obesity. Certain categories of COVID-19 patients are also at increased risk, including neonates and pregnant women. In the present article, we delineate the reported risk factors for acquisition of infection, and for increased severity of the clinical disease. We also comparatively analyze those risk factors associated with COVID-19 and with the antecedent human acute respiratory syndrome-causing viruses, SARS-CoV-1 and MERS-CoV. We hypothesize that the structural similarities of the three viruses predict a similarity in the profile of high-risk patients. Several pathophysiological patterns have been detected to support this theory.

Short and Long Term Outcome In Patients with Calcified Lesions Requiring Rotational Artherectomy

Objective: Despite the evolution of interventional techniques and operator experience, percutaneous revascularization of complex coronary lesions especially calcified lesions remains challenging because of lower procedural success and higher restenosis rates. Limited data are available on the effect of rotational atherectomy (RA) plus stenting in the treatment of complex calcified lesions of coronary artery disease. This study was aimed to investigate the characteristics, short and long term outcomes in patients undergoing RA.&#x0D; Material and Methods: A database search was performed from the year 2008 to 2013 in National Heart institute, Malaysia. A total of 16009 patients who underwent PCIs were enrolled in 2 groups, RA group (258 patients) and non RA group (15751 patients). The Chi square test and Kaplan - Meier analysis were used.&#x0D; Results: Male patients (73.6%) and elderly population (63.2%) were predominant in this study.The RA group had more co-morbidities such as diabetic on insulin (34%) and chronic kidney disease (57%). The lesions in RA group were more complex with higher Type C lesion (68.8%) and longer lesion (20.6%) compared to non RA group. Despite higher patient risk profile, the success rate of revascularization remains high in RA group (99.3%) as in non RA group (97%) (p value 0.89%). More importantly there were no significant difference in in-hospital mortality, myocardial infarction and stent thrombosis in both group (p value 0.1). In 1 year Kaplan - Meier survival graph, there were better survival noted in non RA group (97.7%) compare to RA (89.6%) (p value &lt;0.005),&#x0D; Conclusion: The use of RA allows debulking of a calcified lesion and possibly explains the higher acute procedural success rates. However, the lower 1-yearsurvival in the RA group highlights the higher associated baseline comorbitidity in this group. Therefore, besides coronary intervention, this RA group requires aggressive medical therapy through a multi-disciplinary approach.&#x0D; Bangladesh Heart Journal 2020; 35(2) : 140-146

One-year clinical outcome of patients with nonvalvular atrial fibrillation: Insights from KERALA-AF registry

BackgroundWe report patient characteristics, treatment pattern and one-year clinical outcome of nonvalvular atrial fibrillation (NVAF) from Kerala, India. This cohort forms part of Kerala Atrial Fibrillation (KERALA-AF) registry which is an ongoing large prospective study. MethodsKERALA-AF registry collected data of adults with previously or newly diagnosed atrial fibrillation (AF) during April 2016 to April 2017. A total of 3421 patients were recruited from 53 hospitals across Kerala state. We analysed one-year follow-up outcome of 2507 patients with NVAF. ResultsMean age at recruitment was 67.2 years (range 18–98) and 54.8% were males. Main co-morbidities were hypertension (61.2%), hyperlipidaemia (46.2%) and diabetes mellitus (37.2%). Major co-existing diseases were chronic kidney disease (42.1%), coronary artery disease (41.6%), and chronic heart failure (26.4%). Mean CHA2DS2-VASc score was 3.18 (SD ± 1.7) and HAS-BLED score, 1.84 (SD ± 1.3). At baseline, use of oral anticoagulants (OAC) was 38.6% and antiplatelets 32.7%. On one-month follow-up use of OAC increased to 65.8% and antiplatelets to 48.3%. One-year all-cause mortality was 16.48 and hospitalization 20.65 per 100 person years. The main causes of death were cardiovascular (75.0%), stroke (13.1%) and others (11.9%). The major causes of hospitalizations were acute coronary syndrome (35.0%), followed by arrhythmia (29.5%) and heart failure (8.4%). ConclusionsDespite high risk profile of patients in this registry, use of OAC was suboptimal, whereas antiplatelets were used in nearly half of patients. A relatively high rate of annual mortality and hospitalization was observed in patients with NVAF in Kerala AF Registry.

Transcarotid versus transfemoral access in patients undergoing transcatheter aortic valve replacement with complex aortofemoral anatomy.

While major vascular complications (MVC) remains an issue after Transfemoral (TF) transcatheter aortic valve replacement (TAVR), we compared outcomes in TF versus transcarotid (TC) approaches in patients with complex vascular anatomy. Among patients undergoing TAVR in our center between 2015 and 2018, we evaluated patients with complex vascular anatomy defined on CT scan as: (a) iliofemoral diameter between 5.5 and 6 mm or <6.5 mm with severe calcifications or tortuosity AND/OR (b) abdominal aorta pathology. The primary endpoint included access failure, mortality, MVC, major bleeding and stroke at 1-month. Among 483 patients, 131 (31.2%) with complex vascular anatomy underwent TF (n= 51;39.2%) or TC (n= 80;60.8%) TAVR. The mean age was 81.7± 6.9. TC group had higher STS score (p= .01), higher incidence of coronary artery disease (p= .04) and lower left ventricular ejection fraction (p< .001). In TC group, primary endpoint occurred twice less without reaching significance compared to TF group (n= 8; 10.0% vs. n= 10; 19.6% respectively; p= .1). Incidence of MVC was higher in TF group (11.8 vs. 1.3% in the TC group; p= .01) with similar incidence of stroke between groups (p= .8). Despite higher patient risk profile, TC approach in complex aortofemoral anatomy provides similar favorable outcomes with less MVC compared to TF approach.

Clinical outcomes of mitral valve intervention in patients with mitral annular calcification: A systematic review and meta-analysis.

Mitral valve (MV) disease with mitral annular calcification (MAC) poses a surgical challenge and the clinical outcomes of MV surgery as well as transcatheter mitral valve replacement (TMVR) remain relatively unexplored. We performed a systematic review and meta-analysis to assess the effects of MAC on clinical outcomes following MV surgery and TMVR. We searched MEDLINE and EMBASE databases until February 2019 for studies comparing clinical outcomes of MV surgery or TMVR in patients with and without MAC. Data were extracted by two independent investigators. Outcomes were perioperative and midterm complications and mortality. Seven observational studies enrolling 2902 patients were included. MAC patients were older, more likely to be female with greater chronic lung disease and kidney failure. Perioperative mortality was similar between patients with and without MAC undergoing MV surgery (risk ratio [RR], 1.15; 95% confidence interval [CI], 0.50-2.65; P = .74). MAC was associated with a higher risk of bleeding, permanent pacemaker implantation, and periprosthetic leak. Midterm mortality was greater in MAC patients undergoing MV surgery (incident rate ratio [IRR], 1.32; 95% CI, 1.05-1.67; P = .02). MAC patients undergoing TMVR had higher perioperative (RR, 4.65; 95% CI, 2.93-7.38; P < .01) and 1-year (RR, 5.44; 95% CI, 3.49-8.49; P < .01) mortality, decreased procedural success, greater left ventricular outflow tract obstruction and need for conversion to surgery when compared with patients undergoing TMVR for dysfunction of a bioprosthetic valve or annuloplasty ring. MV procedures in patients with MAC are associated with higher mortality and morbidity. This is largely driven by the high-risk patient profile associated with MAC. TMVR holds promise but has important limitations and should be reserved for select patients.

Systematic review and evaluation of freely available online diabetes medication decision aids

Rationale, aims and objectives: Diabetes mellitus is likely to be in the top 10 leading global burden of diseases by 2030, where self-management of diabetes is one avenue to alleviate burden. Shared decision-making processes and the use of decision aids may help facilitate self-management in patients with diabetes. We aimed to identify and assess all publicly available online diabetes medication decision aids, for suitability for low health literate patients, in terms of their understandability and actionability. Methods: Systematic review of public websites in August-November 2017 using an environmental scan methodology, assessment of clinical validity using a high-risk patient profile, assessment of understandability and actionability using the PEMAT-P subscales, readability using the Gunning Fog Index and Flesch­-Kincaid Reading score and ratings against the International Patient Decision Aids Standards Instrument Short Form (IPDASi-SF) and Version 4. Results: Seven diabetes medication decision aids were identified in this study. The mean understandability score was 88% (SD = 10%) the mean actionability score was 52% (SD = 24%) which ranged from 17 to 80%. The mean Gunning Fog index was 10.8 (SD = 0.7), the mean Flesch­-Kincaid Reading Score was 10.1 (SD = 0.7) the mean IPDASi-SF score was 57.34 ( SD =9.86). The Development subscale scores for the IPDASi-SF were poor (mean 1). Conclusions: Understandability of the decision aids overall was good however with the US 10 th grade reading levels they may not be suitable for a low health literacy audience. Actionability was also less than favourable.

Factors associated with involuntary hospitalisation for psychiatric patients in Switzerland: a retrospective study

BackgroundDespite the scarce evidence for patients’ benefits of coercion and its well-documented negative effects, the use of compulsion is still very common around Europe, with important variations among different countries. These variations have been partially explained by the different legal frameworks, but also by several individual-related, system-related and area-related characteristics, identified as predictors of the use of coercive measures. This study aimed to compare the socio-demographic and clinical profile as well as the referral and hospitalisation process of people voluntarily and involuntarily hospitalized in order to identify which factors could be associated with the use of coercion.MethodsAll psychiatric admissions occurred between the 1st January 2015 and the 31st December 2015 were included in this retrospective study (n = 5027). The whole sample was split into two subgroups accordingly to the hospitalisation legal status at admission (voluntary vs involuntary) and differences between the two groups were examined. In order to identify the factors associated with coercion, all the variables reaching a p < .01 level of significance when comparing the two groups were included as independent variables into a multivariate logistic regression model.ResultsGlobally, 62% of the admissions were voluntary and 38% were involuntary. Compared to the voluntary group, involuntary patients were significantly older, more frequently widowed and living in one specific district, and had a main diagnosis of schizophrenia (F20-F29) or organic mental disorders (F00-F09). People affected by organic mental disorders (F00-F09), with higher levels of psychotic symptoms, aggression and problems with medication adherence, were more likely to be involuntarily admitted. Moreover, living in District 1, being referred by a general practitioner, a general hospital or a psychiatric hospital and being involuntarily admitted during the previous 12 months, was associated with a higher risk of coercion.ConclusionsThis study identified several individual-related, as well as system-related factors associated with the use of coercion. These results allowed us to trace a clearer profile of high-risk patients and to provide several inputs that could help local authorities, professionals and researchers to develop better-targeted alternative interventions reducing the use of coercion.

Clinical Outcomes of Mitral Valve Reoperations in the United States: An Analysis of The Society of Thoracic Surgeons National Database

This study evaluated outcomes of reoperative mitral valve surgery (MVS) in the United States. Adults undergoing isolated MVS with prior open-heart operation in The Society of Thoracic Surgeons (STS) National Database between July 2011 and September 2016 were included. Urgent or emergent operations as well as all indications and causes for MVS were included. Primary outcomes were operative mortality and morbidity. Multivariable models were used for risk-adjustment, incorporating variables from the STS Valve Risk Model as well as type of prior operation and reoperative approach. A total of 17,195 patients underwent isolated reoperative MVS at 962 centers. The STS predicted risk of mortality was 8.0%, with 20% having an STS predicted risk of mortality greater than 10%. Prior cardiac operations included previous MVS (61%), coronary artery bypass (39%), aortic valve surgery (18%), and tricuspid valve surgery (6%). Operative mortality for the overall study cohort was 6.6%, and postoperative stroke occurred in 2.4%. Observed-to-expected mortality for the overall cohort was 0.82. The strongest independent predictors of operative mortality included salvage operation, preoperative dialysis dependence, congestive heart failure, recent myocardial infarction, and active endocarditis. Prior aortic valve replacement was associated with increased mortality risk, whereas prior MVS reduced mortality risk. Surgical approach did not affect mortality. For patients with prior MVS undergoing elective, non-endocarditis operations, the operative mortality was3.4%. Despite a high-risk patient profile, surgical outcomes of reoperative MVS were acceptable, particularly in patients with prior MVS and without endocarditis undergoing elective operations.

Clinical Validity, Understandability, and Actionability of Online Cardiovascular Disease Risk Calculators: Systematic Review.

BackgroundOnline health information is particularly important for cardiovascular disease (CVD) prevention, where lifestyle changes are recommended until risk becomes high enough to warrant pharmacological intervention. Online information is abundant, but the quality is often poor and many people do not have adequate health literacy to access, understand, and use it effectively.ObjectiveThis project aimed to review and evaluate the suitability of online CVD risk calculators for use by low health literate consumers in terms of clinical validity, understandability, and actionability.MethodsThis systematic review of public websites from August to November 2016 used evaluation of clinical validity based on a high-risk patient profile and assessment of understandability and actionability using Patient Education Material Evaluation Tool for Print Materials.ResultsA total of 67 unique webpages and 73 unique CVD risk calculators were identified. The same high-risk patient profile produced widely variable CVD risk estimates, ranging from as little as 3% to as high as a 43% risk of a CVD event over the next 10 years. One-quarter (25%) of risk calculators did not specify what model these estimates were based on. The most common clinical model was Framingham (44%), and most calculators (77%) provided a 10-year CVD risk estimate. The calculators scored moderately on understandability (mean score 64%) and poorly on actionability (mean score 19%). The absolute percentage risk was stated in most (but not all) calculators (79%), and only 18% included graphical formats consistent with recommended risk communication guidelines.ConclusionsThere is a plethora of online CVD risk calculators available, but they are not readily understandable and their actionability is poor. Entering the same clinical information produces widely varying results with little explanation. Developers need to address actionability as well as clinical validity and understandability to improve usefulness to consumers with low health literacy.

An evaluation of mini-laparotomy cholecystectomy in the laparoscopic era: a rural experience

Laparoscopic cholecystectomy (LC) is the gold standard for the management of symptomatic cholelithiasis and complications of gallstone disease. Mini laparotomy cholecystectomy (MOC) may be a more appropriate option in the resource constrained rural setting due to its widespread applicability and comparable outcome with LC. The study aimed to provide an epidemiological analysis of gallstone disease in the rural population and to evaluate the outcome of MOC in a rural hospital. A retrospective chart analysis of 248 patients undergoing cholecystectomy in a rural regional referral hospital in KwaZulu-Natal from January 2009 to December 2013 was undertaken. Of the 248 patients, the majority were females (n = 211, [85%]). The most frequent indications for cholecystectomy included: biliary colic (n = 115, [46.3%]); acute cholecystitis (n = 80, [32.3%]); gallstone pancreatitis (n = 27, [10.8%]). Forty cases (16.1%) were converted to open cholecystectomy (OC). The median operative time was 40 minutes (range18-57). Twenty-three morbidities (9.3%) occurred including: bile leaks (n = 6, [2.4%]); bleeding from drain site (n = 1, [0.4%]), incisional hernia (n = 8 [3.2%]) and wound sepsis (n = 8 [3.2%]). The median length of hospital stay in patients who underwent MOC was 48 hours (range: 24-72 hours) and the median time to return to work was 10 days (range: 4-14 days). There was one mortality in the entire cohort. MOC is a safe and feasible operation for symptomatic cholelithiasis when cholecystectomy is indicated. The low operative morbidity and mortality in the context of a high risk patient profile and complicated gallstone disease makes this procedure an alternative to LC where LC is inaccessible.

Reproducibility and Inter-rater Reliability of 2 Paediatric Nutritional Screening Tools.

The aim of the present study was to assess reproducibility and inter-rater reliability of 2 nutritional screening tools (NST): Screening Tool for Risk on Nutritional Status and Growth (STRONGkids) and Screening Tool for the Assessment of Malnutrition in Paediatrics (STAMP). Prospective observational multicentre study. Patients ages 1 month or older admitted to paediatric or surgical wards were tested within 24 hours of admission by 2 independent observers: experts specialized in paediatric nutrition (physicians or dieticians) and clinical staff nonexpert in nutrition. Diagnosis on admission, underlying diseases, and length of stay were registered. Kappa index (κ) to evaluate agreement between observers. A total of 223 patients were included (53.4% boys), with mean age of 5.59 (95% confidence interval 4.94-6.22) years. Experts classified 9.9% of patients at high risk with STRONGkids and 19.7% using STAMP, whereas nonexpert staff assigned 6.7% of patients to the high-risk category with STRONGkids and 21.9% with STAMP. Agreement between expert and nonexpert staff was good: 94.78% for STRONGkids (κ 0.72 [P < 0.001]); 92.55% for STAMP (κ 0.74 [P < 0.001]). The rate of malnutrition was significantly higher among high-risk patients with both NST, independent of examiner experience. After adjusting for age, both STRONGkids and STAMP high-risk scores predicted longer length of stay, whether assessed by experts or nonexperts, although differences were higher with STRONGkids. Agreement between experts and nonexpert staff in nutrition was good, producing a similar high-risk patient profile. Our results demonstrate that these NSTs are appropriate for nutritional screening in settings in which users have no previous experience in the field.

Out of theatre sedation – how I do it safely

No abstract available.

Early Outcomes of Coronary Endarterectomy in Patients Undergoing Coronary Artery Bypass Surgery.

Coronary endarterectomy (CE) is performed as an adjunct to coronary artery bypass surgery (CABG); however, the efficacy of this technique is still controversial. We aimed to evaluate the impact of CE combined with CABG when compared with isolated CABG. Patients who underwent CABG between July 2007 and June 2014 were included. 70 of 2452 patients (2.8%) underwent CE in addition to CABG. Early results were compared with isolated CABG and predictors of adverse outcome were measured in stepwise multivariate logistic regression analyses. The incidence of comorbidities including prior myocardial infarction, diabetes mellitus, and three-vessel coronary disease in CE patients was higher; however, mortality (4.3% versus control 3.6%; P = .762) and postoperative complications were not significantly increased in this group of patients (except supraventricular arrhythmia). Although age greater than 70 years, impaired ejection fraction, intraoperative intraaortic balloon pump, and prolonged cardiopulmonary bypass time were important predictors of adverse outcomes, CE was not associated with increased mortality or postoperative morbidities. Despite the higher risk profile of patients who underwent CE, this technique was not identified as an independent risk factor for adverse postoperative outcomes.

Temporal Trends in Clinical Outcome After Percutaneous Coronary Intervention 1984-2010 - Report From the Juntendo PCI Registry.

Since the introduction of PCI in 1977, it has evolved along with advances in the technology, improvement in operator technique and establishment of medical therapy. However, little is known of the improvement in clinical outcome following PCI. Data from the Juntendo PCI Registry during 1984-2010 were analyzed. The patients were divided into 3 groups according to date of index PCI: POBA era, January 1984-December 1997; BMS era, January 1998-July 2004; and DES era, August 2004-February 2010. The primary endpoint was a composite of MACE including all-cause mortality, non-fatal MI, non-fatal stroke and revascularization. A total of 3,831 patients were examined (POBA era, n=1,147; BMS era, n=1,180; DES era, n=1,504). Mean age was highest in the DES era. The prevalence of diabetes and hypertension was higher in the DES and BMS eras than in the POBA era. Unadjusted cumulative event-free survival rate for 2-year MACE was significantly different across the 3 eras. Adjusted relative risk reduction for 2-year MACE was 56% in the DES era and 34% in the BMS era, both compared with the POBA era. Age, ACS, and LVEF were associated with the incidence of MACE. Clinical outcome of PCI improved across the 26-year study period, despite the higher patient risk profile in the recent era.

Prolonged Effect of Postoperative Infectious Complications on Survival After Cardiac Surgery

Whether patients having infections after cardiac surgery are at a survival disadvantage after hospital discharge is unclear. Our objectives were (1) to identify characteristics of such patients and (2) to determine whether this complication is associated with increased mortality beyond hospital discharge. In all, 30,414 patients were discharged after isolated coronary artery bypass grafting, valve, ascending aorta repair, or combined procedures from January 2000 to January 2011. Surgical site infection, septicemia, pneumonia, and urinary tract infection occurred in 1,868 patients (6.1%). Propensity matching was used to account for differences in perioperative characteristics and postoperative in-hospital events between these patients and those not having postoperative infections, to give 1,593 propensity-matched pairs. Time-related mortality and instantaneous risk were compared. Surgical site infection occurred in 122 patients (0.40%), sternal wound infection in 263 (0.86%), septicemia in 656 (2.2%), urinary tract infection in 853 (2.8%), and pneumonia in 513 (1.7%). Infections were associated with older age, female sex, larger body mass index, and multiple comorbidities. Among 1,593 propensity-matched pairs, postdischarge survival at 6 months and at 1, 5, and 10 years, respectively, was 89%, 86%, 67%, and 45% for patients without infections, and 86%, 83%, 63%, and 43% (p = 0.008) for patients with infections. Survival differences resulted from a higher, but gradually declining, early instantaneous risk during the first year after surgery. Elevated risk was of shorter duration for surgical site infections than for other infections. Postoperative infection is associated with a high-risk patient profile, and risk of death is elevated early after hospital discharge. Reasons for this prolonged effect are unclear.

Estudios de eficacia

Pravafenix® is a fixed-dose combination of 40mg of pravastatin and 160mg of fenofibrate. The rationale behind the use of Pravafenix® is based on the increased residual cardiovascular risk observed in high risk patients with hypertriglyceridemia and/or low HDL cholesterol levels despite treatment with statins in monotherapy. In this article, we review the available evidence on the clinical efficacy of Pravafenix®, which shows complementary benefits in the overall lipid profile of high risk patients with mixed dyslipidemia not controlled with 40-mg pravastatin or 20-mg simvastatin.