Initial Invasive or Conservative Strategy for Stable Coronary Disease.

BACKGROUND: Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain. METHODS: We randomly assigned 5179 patients with moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. A key secondary outcome was death from cardiovascular causes or myocardial infarction. RESULTS: Over a median of 3.2 years, 318 primary outcome events occurred in the invasive-strategy group and 352 occurred in the conservative-strategy group. At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0). Results were similar with respect to the key secondary outcome. The incidence of the primary outcome was sensitive to the definition of myocardial infarction; a secondary analysis yielded more procedural myocardial infarctions of uncertain clinical importance. There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32). CONCLUSIONS: Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. The trial findings were sensitive to the definition of myocardial infarction that was used. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).

Rationale and design of the TUXEDO-2 India study: Ultra-Thin strUt Supraflex Cruz versus XiencE in a Diabetic pOpulation with multi-vessel disease-2.

BACKGROUND: The role of percutaneous coronary interventions (PCI) in patients with diabetes mellitus and multi-vessel disease has been questioned by the results of the FREEDOM trial, which showed superiority of coronary artery bypass graft(CABG) over first generation drug-eluting stents (DES) including a reduction in mortality. In the light of safer and more efficacious stents and significantly better medical management, those results that date back to 2012 need to be revisited. TUXEDO-2 is a study designed to compare two contemporary stents in Indian diabetic patients with multi-vessel disease. AIMS: The primary objective of the TUXEDO-2 study is to compare the clinical outcomes of PCI with ultra-thin Supraflex Cruz vs Xience when combined with contemporary optimal medical therapy (OMT) in diabetic patients with multi-vessel disease. The secondary objective is to compare clinical outcomes between a pooled cohort from both arms of the study (Supraflex Cruz + Xience; PCI arm) vs CABG based on a performance goal derived from the CABG arm of the FREEDOM trial (historical cohort). The tertiary objective is a randomized comparison of ticagrelor vs prasugrel in addition to aspirin for the composite of ischemic and bleeding events. METHODS: In this prospective, open-label, multi-centre, 2 × 2 factorial, randomized, controlled study, 1,800 patients with diabetes mellitus and multi-vessel disease (inclusion criteria similar to FREEDOM trial) with indication for coronary revascularization will be randomly assigned to Supraflex Cruz or Xience stents and also to ticagrelor- or prasugrel- based antiplatelet strategies. All patients will receive guideline directed OMT and optimal PCI including image- and physiology-guided complete revascularization where feasible. The patients will be followed through five years to assess their clinical status and major clinical events. The primary endpoint is a non-inferiority comparison of target lesion failure at one-year for Supraflex Cruz vs Xience (primary objective) with an expected event rate of 11% and a non-inferiority margin of 4.5%. For PCI vs CABG (secondary objective), the primary endpoint is major adverse cardiac events (MACE), defined as a composite of all cause death, nonfatal myocardial infarction, or stroke at one-year and yearly up to five years, with a performance goal of 21.6%. For ticagrelor vs prasugrel (tertiary objective), the primary endpoint is composite of death, myocardial infarction, stroke, and major bleeding as per the Bleeding Academic Research Consortium (BARC) at one-year with expected event rate of 15% and a non-inferiority margin of 5%. CONCLUSIONS: The TUXEDO-2 study is a contemporary study involving state-of-the-art PCI combined with guideline directed OMT in a complex subset of patients with diabetes mellitus and multi-vessel disease. The trial will answer the question as to whether a biodegradable polymer coated ultra-thin Supraflex Cruz stent is an attractive option for PCI in diabetic patients with multi-vessel disease. It will also help address the question whether the results of FREEDOM trial would have been different in the current era of safer and more efficacious stents and modern medical therapy. In addition, the comparative efficacy and safety of ticagrelor vs prasugrel in addition to aspirin will be evaluated. (CTRI/2019/11/022088).

Valvular heart disease in Antiphospholipid antibody syndrome: Isolated Tricuspid stenosis.

Antiphospholipid antibody syndrome (APLS) is a rare disorder characterized by a hypercoagulable state. Manifestations include arterial or venous thrombosis, recurrent fetal wastage, coronary artery disease, valvular heart disease, dilated cardiomyopathy, pulmonary artery hypertension, and intracardiac thrombus. Most commonly mitral valve is affected followed by aortic and then tricuspid valve. In this report, a rare case of spontaneous aortic thrombosis with tricuspid stenosis uncomplicated by other valve lesions is presented with clinical and echocardiographic studies and computed tomographic images.

Prosthetic mitral valve thrombosis, malfunction, and paroxysmal mitral regurgitation.

Intermittent dysfunction of mechanical mitral valve prosthesis is an uncommon condition. It carries serious clinical implications if unrecognized. Here, we present a case of a 28-year-old female with a history of rheumatic multivalvular disease, for which she had undergone double valve replacement and tricuspid annuloplasty. Six months later, she presented with heart failure. Clinical examination revealed intermittent loss of closing clicks followed by a pansystolic murmur at the apex, suggestive of mitral prosthetic valve dysfunction. We highlight the echocardiographic findings of paroxysmal mitral valvular regurgitation secondary to prosthetic valve malfunction secondary to prosthetic valve thrombosis.

Peeling off the Mask: Pseudo Myocardial Infarction Pattern on Electrocardiogram During AICD Implantation.

Lead induced transient right bundle branch block is not uncommon during pacemaker implantation. We describe a patient with old anterior wall myocardial infarction with severe left ventricular dysfunction presenting with recurrent ventricular tachycardia who developed transient right bundle branch block and pseudomyocardial infacrction pattern during AICD implantation.

Percutaneous stenting of interrupted aortic arch to treat compressive myelopathy.

Neurological complications of coarctation of aorta include spontaneous SAH, intracerebral hemorrhage, and cerebral abscess. Interrupted aortic arch (IAA) present as compressive myelopathy is not known. We describe an adult male presenting to neurology department with progressive paraparesis and was detected to have IAA with intraspinal collaterals causing compressive myelopathy. He was successfully treated with percutaneous stenting of IAA with dramatic improvement in paraparesis. © 2014 Wiley Periodicals, Inc.

Rheumatic severe mitral stenosis with complete heart block.

Rheumatic fever presenting with complete heart block is very rare and usually transient. We describe a child with chronic severe rheumatic mitral stenosis with persistent complete heart block with interesting echocardiographic findings.

Left ventricular hydatid cyst: an uncommon cause of chest pain in young adults.

Isolated cardiac involvement in hydatid disease is very rare. We report the case of a young adult male who presented to the emergency department with acute onset of chest pain and was surprisingly detected to have a hydatid cyst in the left ventricular myocardium. The transthoracic echocardiography and cardiac magnetic resonance imaging confirmed the diagnosis. Cardiac hydatid disease should be considered in the differential diagnosis of chest pain in young individuals in the absence of conventional risk factors of atherosclerosis.

Impact of Complete Revascularization in the ISCHEMIA Trial.

BACKGROUND: Anatomic complete revascularization (ACR) and functional complete revascularization (FCR) have been associated with reduced death and myocardial infarction (MI) in some prior studies. The impact of complete revascularization (CR) in patients undergoing an invasive (INV) compared with a conservative (CON) management strategy has not been reported. OBJECTIVES: Among patients with chronic coronary disease without prior coronary artery bypass grafting randomized to INV vs CON management in the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trial, we examined the following: 1) the outcomes of ACR and FCR compared with incomplete revascularization; and 2) the potential impact of achieving CR in all INV patients compared with CON management. METHODS: ACR and FCR in the INV group were assessed at an independent core laboratory. Multivariable-adjusted outcomes of CR were examined in INV patients. Inverse probability weighted modeling was then performed to estimate the treatment effect had CR been achieved in all INV patients compared with CON management. RESULTS: ACR and FCR were achieved in 43.4% and 58.4% of 1,824 INV patients. ACR was associated with reduced 4-year rates of cardiovascular death or MI compared with incomplete revascularization. By inverse probability weighted modeling, ACR in all 2,296 INV patients compared with 2,498 CON patients was associated with a lower 4-year rate of cardiovascular death or MI (difference -3.5; 95% CI: -7.2% to 0.0%). In comparison, the event rate difference of cardiovascular death or MI for INV minus CON in the overall ISCHEMIA trial was -2.4%. Results were similar but less pronounced with FCR. CONCLUSIONS: The outcomes of an INV strategy may be improved if CR (especially ACR) is achieved. (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches [ISCHEMIA]; NCT01471522).

An alternative angiographic view to unmask the hidden patent ductus arteriosus during device closure.

Transcatheter closure of patent ductus arteriosus (PDA) with various devices has been evaluated worldwide and in selected cases can be performed successfully, thus avoiding the morbidity associated with surgical closure. Traditionally, left lateral projection is adopted for angiographic visualization of the PDA. However, rarely due to anatomical variations of the ductus, it may be difficult to properly visualize and deploy device in above-said traditional view. In such cases, right anterior oblique projection may be used for proper visualization.

The role of noninvasive imaging in early diagnosis of clinically masked prepulseless inflammatory phase of Takayasu's Arteritis.

Diagnosis of early-phase Takayasu's arteritis (TA) is extremely difficult and overlooked as most often presentation is nonspecific and mimics various other diseases. Early diagnosis and initiation of proper therapy could alter the natural course of the disease. We describe an adolescent male presenting with pyrexia of unknown origin and clinical features simulating idiopathic dilated cardiomyopathy. Transthoracic echocardiography was suggestive of dilated cardiomyopathy with severe left ventricular dysfunction. Later vascular ultrasonography and CT aortography showed extensive thickening of intima-media of aorta and its major branches suggestive of inflammatory phase of TA. We discuss the role of noninvasive imaging in diagnosis of clinically masked prepulseless inflammatory phase of TA.

Tetralogy of Fallot with infective endocarditis: an echocardiographic explanation of misleading clinical signs.

Echocardiography has a known key role in the diagnosis of infective endocarditis, the diagnosis of complications, follow-up evaluation after therapy, and prognostic assessment Habib (Eur J Echocardiogr 11:202-219, 3). This report describes a boy with tetralogy of Fallot who presented with infective endocarditis and large vegetation occluding the ventricular septal defect, thus resulting in a hemodynamically restrictive ventriculoseptal defect with misleading clinical signs. This case illustrates the role of echocardiography in both explaining clinical signs and providing hemodynamic data.

Tracking the path traversed by temporary pacing lead.

Persistent left superior vena cava (PLSVC) results from abnormal development of the sinus venosus in the early stages of fetal life. Though there are numerous reports of successful permanent pacemaker implants in such cases, placement of permanent pacing leads in such cases is technically challenging, often requiring shaping of stylets and considerable lead maneuvering. We describe an interesting case wherein a temporary pacemaker lead after entering the PLSVC followed an unusual fluoroscopic course with demonstrable pacing in right ventricle (RV), right atrium (RA) and the left ventricle (LV). Interventional cardiologists and intensivists performing pacing procedures need to be aware that one may rarely encounter such interesting radiographic and electrocardiographic patterns in these cases with anomalous systemic venous drainage.

"Add-on pacing lead": an effective and safe alternative to lead replacement in ICD pacing failure.

Despite recent advances in implantable cardioverter defibrillator (ICD) technology, the long-term reliability of ICD leads remains a significant problem. Lead failures constitute a major risk for patients with an implantable cardioverter defibrillator. There is no clear consensus on treatment strategy of ICD lead failure and decision should be individualized. We report a pacing-dependent elderly male with ICD lead pacing failure secondary to insulation break resulting in recurrent syncope. We emphasize the technique of "Add-on pacing lead implantation" could be an effective and alternative to ICD lead replacement.

Thrombolytic therapy in prosthetic valve thrombosis during early pregnancy.

Regardless of the improvements in the design of prosthetic heart valves and the use of anticoagulation, systemic embolism and valve thrombosis remains the most dreaded complications of mechanical heart valve replacement. A course of thrombolytic therapy may be considered as a first-line therapy for prosthetic heart valve thrombosis. The safety of thrombolysis in early pregnancy is not known. We describe a primigravida with mitral valve replacement status presenting with acute prosthetic valve thrombosis and treated successfully with intravenous streptokinase.

Successful balloon mitral valvotomy in rheumatic mitral stenosis with Ebstein's anomaly.

The association of Ebstein's anomaly of tricuspid valve with rheumatic mitral stenosis is extremely rare. The case is presented of a young female who had been admitted with progressive dyspnea secondary to severe rheumatic mitral stenosis with moderate pulmonary hypertension, along with Ebstein's anomaly of tricuspid valve. The patient underwent successful balloon mitral valvotomy, using the Inoue technique, with a marked improvement in her symptoms.

Sequential single-stage percutaneous balloon dilatation of an inferior vena cava obstruction with rheumatic mitral stenosis.

The case is reported of severe rheumatic mitral stenosis (MS) associated with asymptomatic inferior vena cava (IVC) occlusion, detected incidentally while performing percutaneous balloon mitral valvotomy (PBMV). The patient successfully underwent a single-stage balloon dilatation of the membranous obstruction in the IVC, followed by PBMV using the Inoue technique. The case represents a rare, incidental concurrence of IVC obstruction and severe rheumatic MS. This rare hybrid percutaneous sequential balloon dilatation is the first of its type to be reported, and highlights the growing experience of percutaneous interventional techniques in the management of such complex cases.

Takayasu's arteritis mimicking unilateral pulmonary artery agenesis in a child with severe pulmonary hypertension and right heart failure: a diagnostic dilemma.

Affliction of the pulmonary arteries in Takayasu's arteritis is uncommon. Moreover the incidence of pulmonary artery involvement in this condition is often underestimated because of asymptomatic nature in most patients. Severe involvement may however present with pulmonary artery hypertension and hemoptysis, which may prove to be fatal. This case report describes a 9-year-old girl with severe pulmonary hypertension and right heart failure secondary to total occlusion of the right pulmonary artery. Detailed clinical examination and computed tomography (CT) angiography confirmed this diagnosis.

A mysterious pacemaker suture: an uncommon foreign body reaction.

Surgical suture material is usually inert and nontoxic and causes minimal inflammation of tissue. However, foreign body reactions to various suture types can lead to granuloma, abscess, or even sinus formation. We report an elderly female who was incidentally detected to have a mass protruding from the incision site which was confirmed histopathologically a chronic granulomatous reaction to non absorbable suture. The foreign body granulomatous reaction to suture material in the setting of pacemaker implantation has not been described in the literature. We also discuss the existing literature on this underrecognised entity.

Role of Angiotensin-Converting Enzyme (ACE) gene polymorphism and ACE activity in predicting outcome after acute myocardial infarction.

BACKGROUND: The Ace polymorphism had shown association with ACE activity, premature atherosclerosis, myocardial infarction, LV dysfunction, LV remodelling, severity and extent of CAD and mortality after MI. Though ACE I/D polymorphism has been reported to be associated with various cardiovascular diseases it remained a controversial risk factor and studies have presented conflicting results. This study was designed to determine the association between ACE) gene insertion/deletion (I/D) polymorphism, ACE activity and acute STEMI in Indian population and to determine its influence on outcome after acute MI. MATERIALS AND METHODS: We investigated 934 patients diagnosed with acute STEMI who underwent thrombolysis. ACE I/D polymorphism was detected by polymerase chain reaction and ACE activity was measured in 615 patients. RESULTS: The prevalence of DD, ID, and II genotypes in our study group were 41.97%, 34.36%, and 23.66% respectively. The ACE polymorphism was not significantly associated with the type of myocardial infarction, the LV ejection fraction, the number of vessels diseased and patency of the vessel after thrombolysis. The polymorphism had no influence on in hospital mortality (P = 0.453). The ACE activity also showed no influence on in hospital mortality (P = 0.482). The age > 60 years, Male gender, occluded artery and severe LV dysfunction (LVEF < 35%) were predictors of in-hospital mortality on multivariate regression analysis. CONCLUSION: There was no differences among ACE (I/D) polymorphism observed in STEMI population. Neither ACE I/D polymorphism nor ACE activity predicted in-hospital mortality inpatients admitted with acute STEMI.