PSYChosomatic Medicine in ONcologIc and Cardiac Disease (PSYCHONIC) Study-A Retrospective and Prospective Observational Research Protocol.

Psychosocial factors play an important role in non-communicable diseases (NCDs). This observational study is primarily aimed at assessing the relationship of psychological characteristics of patients with the outcomes of different NCDs, and to assess short-term psychotherapy (STP) efficacy in the real world. Methods: One hundred and forty patients with recent acute myocardial infarction, Takotsubo syndrome, or non-metastatic breast cancer and a control group of 140 age and sex-matched healthy subjects, will be enrolled. All subjects will be administered psychometric tests, quality of life tests, a specific body perception questionnaire, a dream questionnaire, and a projective test, the Six Drawing test at baseline and follow-up. All subjects with medical conditions will be asked to freely choose between an ontopsychological STP along with standard medical therapy and, whenever indicated, rehabilitation therapy or medical therapy plus rehabilitation alone. The study endpoints will be to evaluate: the relationship of the psychological characteristics of enrolled subjects with the outcomes of different NCDs, predictors of the choice of psychotherapy, and the efficacy of ontopsychological intervention on psychological and medical outcomes. Conclusion: This study will generate data on distinctive psychological characteristics of patients suffering from different CDs and their relationship with medical outcomes, as well as explore the efficacy of ontopsychological STP in these patients in the real world. (Number of registration: NCT03437642).

Psychosocial Risk Factors and Ischemic Heart Disease: A New Perspective.

BACKGROUND: Cardiovascular disease is the most common cause of morbidity and mortality worldwide, with ischemic heart disease (IHD) accounting for roughly 50% of these events in industrialized nations. In recent years, the relative importance of IHD in less industrialized countries is also rising at an alarming and steadily-increasing rate. OBJECTIVES: Many experimental, observational and epidemiological studies have demonstrated the importance of psychosocial risk factors in the development and clinical manifestations of IHD. They act both indirectly, associated with an unhealthy lifestyle; and directly, through the activation of inflammatory cascades and the sympathetic nervous system. They also cluster with biological risk factors to increase the incidence and clinical manifestations of IHD. From these assumptions, there emerges the potential that an integrated approach that incorporates psychological therapy in various forms might reduce IHD patients' symptoms and maladaptive behaviors, and thereby enhance their prognosis. METHODS: To date, three psychotherapeutic approaches have been utilized within cardiac psychology practice: (1) cognitive-behavioral psychotherapy; (2) psychodynamic psychotherapy; and (3) ontopsychological psychotherapy. The current article briefly describes these three approaches and how their use might enhance the care of IHD patients. RESULTS: A range of psychological characteristics influence the development, course and management of cardiac patients' IHD. Among others, these include patients' emotions, attitudes, behaviors, relationships, and stressors. State-of- the-art literature suggests that psychological interventions should be considered in much the same way as medical interventions, in terms of their relevance to both patient management and outcomes. CONCLUSION: For this reason, it is essential that professional psychological and psychotherapeutic support be rendered available to cardiology patients, as a means to enhance both the effectiveness and efficiency of care.

Short-TErm Psychotherapy IN Acute Myocardial Infarction (STEP-IN-AMI) Trial: Final Results.

PURPOSE: The purpose of this research was to assess whether short-term psychotherapy enhances long-term clinical outcomes in patients with a recent acute myocardial infarction (AMI). METHODS: Patients ≤70 years old were randomized within 1 week of their AMI to short-term ontopsychological psychotherapy plus routine medical therapy vs routine medical therapy only. The primary composite outcome was defined as the combined incidence of new cardiovascular events (re-infarction, death, stroke, revascularization, life-threatening ventricular arrhythmias, and the recurrence of clinically significant angina) and clinically significant new comorbidities. Secondary outcome measures were: rates for individual components of the primary composite outcome; the rate of re-hospitalization for cardiovascular problems; and New York Heart Association functional class. RESULTS: Ninety-four patients were analyzed, translating into 425 patient-years. The 2 treatment groups were similar across baseline characteristics. At 5-year follow-up, psychotherapy patients had a lower incidence of primary outcome, relative to controls (77/223 vs 98/202 patient-years, respectively; P = .035; absolute risk reduction = 19%, number needed to treat = 8); this benefit was attributable to the lower incidence of new comorbidities and clinically significant angina in the psychotherapy group. Gains in the primary outcome, relative to controls, among psychotherapy patients occurred in the first year and subsequently remained stable over the following 4 years. CONCLUSIONS: Adding short-term ontopsychological psychotherapy to routine secondary prevention of myocardial infarction improves clinical outcomes overall up to 5 years post AMI. Studying time trends may aid in better targeting of psychological interventions during follow-up. Larger studies remain necessary to confirm these results. TRIAL REGISTRATION: www.ClinicalTrial.gov NCT00769366.

Clinical effects of routine postdilatation of drug-eluting stents.

OBJECTIVES: To assess the clinical effects of postdilatation of drug-eluting stents (DES). BACKGROUND: Subotpimal stent expansion occurs after DES deployment. Postidlatation may improve DES expansion, but it is unclear whether postdilatation may also improve clinical outcomes. METHODS: Since July 2009, we adopted a strategy of routine postdilatation with noncompliant balloons of all DES, while previously postdilatation was performed only for suboptimal results. The first 279 consecutive patients (age 62 ± 9 years, 231 men) who underwent routine postilatation were compared with 262 patients (age 61 ± 9 years, 220 men) who received DES in the previous 6 months (standard treatment). RESULTS: The two groups were similar for age, sex, clinical presentation, and main risk factors, including incidence of diabetes. Routine postdilatation resulted in an improved minimal lumen diameter at the end of the procedure (2.60 ± 0.34 vs. 2.51 ± 0.37 mm, P = 0.003). At 12-month follow-up incidence of MACE (including periprocedural myocardial infarction) was 19.5% in the standard treatment group and 12.5% in routine postdilatation group (P = 0.04), with a significant difference in target vessel revascularization (10.7% vs. 5.4%, P = 0.03), while incidence of myocardial infarction was not significantly different between the two groups (10.7% vs. 9.3%, P = 0.70). Stent thrombosis (definite or probable) occurred in 3 patients in standard treatment group, while no case of stent thrombosis occurred among patients treated with routine postdilatation (1.1% vs. 0%, P = 0.11). CONCLUSIONS: Our results suggest that a strategy of routine postdilatation with non compliant balloons may improve clinical outcomes of DES.

One-year results of the randomized, controlled, short-term psychotherapy in acute myocardial infarction (STEP-IN-AMI) trial.

BACKGROUND: Previous studies on cognitive and interpersonal interventions have yielded inconsistent results in ischemic heart disease patients. METHODS: 101 patients aged ≤ 70 years, and enrolled one week after complete revascularization with urgent/emergent angioplasty for an AMI, were randomized to standard cardiological therapy plus short-term humanistic-existential psychotherapy (STP) versus standard cardiological therapy only. Primary composite end point was: one-year incidence of new cardiological events (re-infarction, death, stroke, revascularization, life-threatening ventricular arrhythmias, and the recurrence of typical and clinically significant angina) and of clinically significant new comorbidities. Secondary end points were: rates for individual components of the primary outcome, incidence of re-hospitalizations for cardiological problems, New York Heart Association class, and psychometric test scores at follow-up. RESULTS: 94 patients were analyzed at one year. The two treatment groups were similar across all baseline characteristics. At follow-up, STP patients had had a lower incidence of the primary endpoint, relative to controls (21/49 vs. 35/45 patients; p=0.0006, respectively; NNT=3); this benefit was attributable to the lower incidence of recurrent angina and of new comorbidities in the STP group (14/49 vs. 22/45 patients, p=0.04, NNT=5; and 5/49 vs. 25/45, p<0.0001, NNT=3, respectively). Patients undergoing STP also had statistically fewer re-hospitalizations, a better NYHA class, higher quality of life, and lower depression scores. CONCLUSION: Adding STP to cardiological therapy improves cardiological symptoms, quality of life, and psychological and medical outcomes one year post AMI, while reducing the need for re-hospitalizations. Larger studies remain necessary to confirm the generalizability of these results. CLINICAL TRIAL REGISTRATION: ClinicalTrial.gov: NCT00769366.

Endothelial progenitor cells predict long-term prognosis in patients with stable angina treated with percutaneous coronary intervention: five-year follow-up of the PROCREATION study.

BACKGROUND: The association between endothelial progenitor cells (EPCs) at the time of percutaneous coronary intervention (PCI) and the subsequent long-term clinical outcome remains undefined. To address this issue, a pre-specified analysis of the PROgenitor Cells role in Restenosis and progression of coronary ATherosclerosis after percutaneous coronary intervention (PROCREATION) study was done. METHODS AND RESULTS: A total of 155 patients with stable angina treated with PCI had flow cytometry before PCI. Patients had a 5-year follow-up. Primary outcome was the composite of major adverse cardiac or cerebrovascular events (MACCE), that is, death, stroke, myocardial infarction, and revascularization. During follow-up, MACCE occurred in 65 of 155 patients (42%). There were no significant differences in clinical and angiographic variables between patients with or without MACCE, apart from a different extent of coronary atherosclerosis. The incidence of MACCE increased significantly over tertiles of CD34+/KDR+/CD45- cells and CD133+/KDR+/CD45- cells, with rates of 25%, 39%, and 69% (P=0.0001), and 26%, 44%, and 59% (P=0.003), respectively. On multivariate analysis it was estimated that the increase in CD34+/KDR+/CD45- cells was associated with a 35% higher risk for MACCE (hazard ratio [HR], 1.75; 95% confidence interval [CI]: 1.07-1.99; P=0.001), and the increase in CD133+/KDR+/CD45- cells was associated with a 25% higher risk for MACCE (HR, 1.35; 95% CI: 1.01-1.74; P=0.03). CONCLUSIONS: Assessment of subpopulations of circulating EPCs in patients with stable angina treated with PCI can improve characterization of long-term prognosis (ClinicalTrials.gov: NCT01575431).

Causes and clinical implications of premature discontinuation of dual antiplatelet therapy.

PURPOSE OF REVIEW: To address the problem of dual antiplatelet therapy (DAPT) discontinuation in patients undergoing surgery. RECENT FINDINGS: In about half of patients who suspend DAPT, the reasons for discontinuation are not known. The price to pay for this suspension is a dramatic increase in mortality and major cardiac adverse events, especially after early suspension (<1 month). This issue on when a patient on DAPT should undergo urgent surgery is particularly important. In this regard, the available literature data regarding DAPT continuation versus suspension and the best way to proceed are conflicting. Another important question is whether DAPT suspension has the same safety profile in all stents. Several studies demonstrated that the second-generation drug-eluting stent compared favorably to the first-generation stents in efficacy and safety, and that DAPT discontinuation after 6 months appears less critical in second-generation stents. Finally, there is the possibility that some psychological risk factors might play a considerable role in stent thrombosis after DAPT discontinuation, but the available data are scarce. SUMMARY: Half of the patients on DAPT discontinue therapy; the earlier the interruption, the higher the risk. Second-generation stents mitigate this scenario. Psychological factors (depression, anxiety, and so on) may reduce patients' compliance and, thereby, increase the risk of cardiovascular events and stent thrombosis.

Identifying factors that predict the choice and success rate of radial artery catheterisation in contemporary real world cardiology practice: a sub-analysis of the PREVAIL study data.

AIMS: To assess: the reasons behind an operator choosing to perform radial artery catheterisation (RAC) as against femoral arterial catheterisation, and to explore why RAC may fail in the real world. METHODS AND RESULTS: A pre-determined analysis of PREVAIL study database was performed. Relevant data were collected in a prospective, observational survey of 1,052 consecutive patients undergoing invasive cardiovascular procedures at nine Italian hospitals over a one month observation period. By multivariate analysis, the independent predictors of RAC choice were having the procedure performed: (1) at a high procedural volume centre; and (2) by an operator who performs a high volume of radial procedures; clinical variables played no statistically significant role. RAC failure was predicted independently by (1) a lower operator propensity to use RAC; and (2) the presence of obstructive peripheral artery disease. A 10-fold lower rate of RAC failure was observed among operators who perform RAC for > 85% of their personal caseload than among those who use RAC < 25% of the time (3.8% vs. 33.0%, respectively); by receiver operator characteristic (ROC) analysis, no threshold value for operator RAC volume predicted RAC failure. CONCLUSIONS: A routine RAC in all-comers is superior to a selective strategy in terms of feasibility and success rate.

Safety of drug eluting stents in patients on chronic anticoagulation using long-term single antiplatelet treatment with clopidogrel.

BACKGROUND: Use of triple therapy with aspirin, clopidogrel, and anticoagulants significantly increases bleeding, thus drug eluting stents (DES) are usually avoided in patients requiring anticoagulation. We tested use of DES vs. BMS using a long-term therapy with clopidogrel only and anticoagulants in this group of patients. METHODS: We enrolled 165 consecutive patients, 79 receiving DES (age 67 +/- 9 years, 84% with atrial fibrillation) and 86 receiving bare metal stents (BMS) (age 70 +/- 11 years, 71% with atrial fibrillation). All patients received aspirin + clopidogrel + oral anticoagulants for 4 weeks, then aspirin was stopped and clopidogrel was continued during the 12-month follow-up. Primary end point was the combined incidence of major adverse coronary events and major bleedings. RESULTS: Incidence of the primary endpoint was 10.1% in patients with DES and 26.7% in patients with BMS (P = 0.01). There was a large difference in incidence of target vessel revascularization (8.1% for DES, 23.3% for BMS, P = 0.01), whereas incidence of myocardial infarction (3.8% in DES vs. 8.1% in BMS) and major bleeding (1.3% vs. 2.3%, respectively) were not significantly different. There were no cases of stent thrombosis. On multivariate Cox regression analysis, the only factor associated with a reduced risk of the primary endpoint was use of DES (hazard ratio 0.35 with 95% confidence interval 0.14-0.85, P = 0.02). CONCLUSIONS: Results of our cohort study suggest that use of DES associated with a treatment with clopidogrel only may be safe and significantly reduce the need for new revascularization in patients requiring chronic anticoagulation.

Rationale and trial design of a randomized, controlled study on short-term psychotherapy after acute myocardial infarction: the STEP-IN-AMI trial (Short Term Psychotherapy in Acute Myocardial Infarction).

OBJECTIVE: A number of previous studies addressed the effect of psychological interventions in patients after acute myocardial infarction (AMI), but it is not known whether psychotherapy might be beneficial after medical and interventional therapy of AMI. We designed a randomized, controlled study to assess the effects of a short-term psychotherapy (STP) on the clinical outcomes of patients who underwent an emergency percutaneous coronary intervention after AMI. METHODS: One hundred consecutive patients undergoing an emergency percutaneous coronary intervention will be randomized 1 week after AMI to medical therapy (control group, C group) or to medical therapy and STP (STP group). Clinical follow-up visits are scheduled at 6 months, 1 and 5 years, whereas psychometric tests (Self-Evaluation test, Modified Maastricht Questionnaire, Social Support Questionnaire, Recent Life Change Questionnaire, Beck Depression Inventory, the MacNew Heart Disease Health-Related Quality of Life Questionnaire, Type D Personality test) are scheduled 1 week after AMI and at 1 year. The primary outcome measures of the study are the cumulative incidence of new cardiological events (myocardial reinfarction, death, stroke, life-threatening ventricular arrhythmias, and recurrence of angina) and the occurrence of new medical disorders. Secondary outcome measures are the incidence of rehospitalizations due to cardiological problems, the prevalence of patients with New York Heart Association class > or = II, left ventricular function, as assessed by echocardiography, and mean score of psychometric tests in the two groups at follow-up. CONCLUSION: Our study has been planned to obtain an insight into how a STP influences clinical outcomes after interventional and medical treatment of AMI.

Transcathether occlusion of interatrial communications: postprocedural transoesophageal echocardiography allows timely detection and treatment of intracardiac thrombus formation.

AIMS: Thrombus formation leading to ischaemic stroke is a major concern after transcathether occlusion of interatrial communications. The aim of our study was to verify if postprocedural transoesophageal echocardiography (TEE) might improve timely detection and management of thrombus formation. METHODS AND RESULTS: We studied 65 patients with patent foramen ovale or atrial septal defect who received an atrial septal closure device. Transoesophageal echocardiography was used to guide the procedure, and was repeated <1 h after the end of the procedure, at 30 day and 6 month follow-up visits. Transoesophageal echocardiography <1 h after procedure revealed a left-sided thrombus attached to the device in three patients. All cases were successfully treated by thrombolytic therapy with full-dose tenecteplase (0.53 mg/kg in 5-10 s) with disappearance of thrombus in 15-60 min. No cerebrovascular event was recorded during a follow-up of 311 +/- 235 days. CONCLUSION: Thrombus formation on interatrial closure devices can occur soon after device implantation and can be timely detected by postprocedural TEE.

Comparison of access-related bleeding complications in women versus men undergoing percutaneous coronary catheterization using the radial versus femoral artery.

Women constitute a high-risk population for bleeding, which is a major prognostic predictor after percutaneous coronary catheterization procedures. We prospectively followed 3,261 consecutive percutaneous coronary procedures performed by radial artery catheterization (RAC) or femoral artery catheterization (FAC). The primary study objective was to determine the relative incidences of in-hospital major and minor puncture-related hemorrhages. Secondary objectives were to (1) identify predictors of major bleeds and (2) estimate how often a second, alternative access site is required for catheterization. In women, no major bleeding occurred after 299 RAC procedures performed, whereas 25 major bleeding episodes occurred after 601 FAC procedures (p = 0.0008). Women who underwent RAC also had a significantly lower incidence of minor hemorrhages than women who underwent FAC (19 of 299, 6.4%, vs 237 of 601, 39.4%, respectively, p = 0.00001). On multivariate analysis, independent predictors of major bleeding were FAC (odds ratio [OR] 27.4, 95% confidence interval [CI] 3.8 to 199.9), use of glycoprotein IIb/IIIa inhibitors (OR 5.6, 95% CI 2.7 to 11.9), female gender (OR 4.5, 95% CI 2.2 to 9.0), age >70 years (OR 2.4, 95% CI 1.2 to 4.8), and an acute coronary syndrome setting (OR 2.4, 95% CI 1.1 to 5.0). Women who underwent RAC were more likely to require a second access site than men (14% vs 1.7%), but operators less selective in RAC use successfully completed the procedure by radial approach in >90% of patients. In conclusion, extensive RAC was more effective at preventing access-related bleeding complications in women than FAC.

Safety and efficacy of short-term celecoxib before elective percutaneous coronary intervention for stable angina pectoris.

Fifty patients with stable angina pectoris entered a randomized, double-blind study and were assigned to receive celecoxib (200 mg 2 times daily) or placebo 7 days before percutaneous coronary intervention (PCI). Results showed that detection of markers of myocardial injury above the upper normal limit was significantly lower in the celecoxib than in the placebo group: 12% versus 35% for creatine kinase-MB (CK-MB; p = 0.001), 20% versus 48% for troponin I (p = 0.0004), and 22% versus 51% for myoglobin (p = 0.0005). Myocardial infarction by CK-MB determination was less commonly seen after PCI in the celecoxib than in the placebo group (5% vs 18%, p = 0.025). Postprocedural peak levels of CK-MB (2.9 +/- 18 vs 7.5 +/- 18 ng/ml, p = 0.0002) were also significantly lower in the celecoxib than in the placebo group. No significant side effect was reported by the 2 groups of patients. In conclusion, pretreatment with celecoxib 200 mg 2 times daily for 7 days significantly decreased procedural myocardial injury in elective PCI. These findings indicate that the antiphlogistic action of cyclo-oxygenase-2 inhibition may provide a friendly protection to ischemic cardiomyocytes.

Effects of the nitric oxide donor nitroprusside on no-reflow phenomenon during coronary interventions for acute myocardial infarction.

We tested the effects of the nitric oxide donor nitroprusside as treatment for no reflow in 23 consecutive patients who underwent coronary angioplasty for acute myocardial infarction. No reflow was defined as a decrease of >/=1 Thrombolysis In Myocardial Infarction (TIMI) trial flow grade occurring after successful initial coronary recanalization. Nitroprusside induced a significant improvement in coronary flow, with an increase in TIMI flow grade from 1.5 +/- 0.8 to 2.9 +/- 0.3 (p <0.0001) and in TIMI frame count from 46 +/- 25 to 16 +/- 5 (p <0.0001). There were no significant adverse effects apart from transient hypotension. Intracoronary nitroprusside should be considered as a treatment of no reflow occurring in acute myocardial infarction.

A uncommon cause of angina during upper limb exercise.

Subclavian artery stenosis or occlusion may be a cause of myocardial ischemia in patients treated using an internal mammary artery graft. Subclavian stenosis may cause myocardial ischemia during arm exercise by a coronary-subclavian steal phenomenon, with flow inversion in the graft from the coronary tree to the left subclavian artery. We here describe a case of a patient developing left subclavian occlusion after coronary artery bypass grafting with the left internal mammary artery. The lesion was successfully treated with a carotid-subclavian bypass. The article underscores the importance of an early diagnosis (possibly before bypass surgery) and discusses possible treatments. Percutaneous interventions with stent implantation appear the treatment of choice, but surgery has an important role in case of total occlusion.