Systematic review and meta-analysis of early aortic valve replacement versus conservative therapy in patients with asymptomatic aortic valve stenosis with preserved left ventricle systolic function.

BACKGROUND: A quarter of patients with severe aortic stenosis (AS) were asymptomatic, and only a third of them survived at the end of 4 years. Only a select subset of these patients was recommended for aortic valve replacement (AVR) by the current American College of Cardiology/American Heart Association guidelines. We intended to study the effect of early AVR (eAVR) in this subset of asymptomatic patients with preserved left ventricle function. METHODS AND RESULTS: We searched PubMed and Embase for randomised and observational studies comparing the effect of eAVR versus conservative therapy in patients with severe, asymptomatic AS and normal left ventricular function. The primary outcome was all-cause mortality. The secondary outcomes were composite major adverse cardiac events (MACE) (study defined), myocardial infarction (MI), stroke, cardiac death, sudden death, the development of symptoms, heart failure hospitalisations and major bleeding. We used GRADEPro to assess the certainty of the evidence. In the randomised controlled trial (RCT) only analysis, we found no significant difference in all-cause mortality between the early aortic intervention group versus the conservative arm (CA) (incidence rate ratio, IRR (CI): 0.5 (0.2 to 1.1), I2=31%, p=0.09). However, in the overall cohort, we found mortality benefit for eAVR over CA (IRR (CI): 0.4 (0.3 to 0.7), I2=84%, p<0.01). There were significantly lower MACE, cardiac death, sudden death, development of symptoms and heart failure hospitalisations in the eAVR group. We noticed no difference in MI, stroke and major bleeding. CONCLUSION: We conclude that there is no reduction in all-cause mortality in the eAVR arm in patients with asymptomatic AS with preserved ejection fraction. However, eAVR reduces heart failure related hospitalisations and death or heart failure hospitalisations. PROSPERO REGISTRATION NUMBER: CRD42022306132.

Safety and Efficacy of OPN Balloon in Patients With Calcified Coronary Artery Disease.

BACKGROUND: Patients with symptomatic calcified coronary lesions have poor outcomes. Such lesions require additional atherectomy devices for bed preparation. AIM: To assess the safety and efficacy of OPN balloon in patients with calcified coronary lesions. METHODS: This is an investigator-initiated, prospective, observational study. The primary outcome of the study was a procedural success. RESULTS: We studied 71 patients (133 lesions). Maximum lesions were located in LAD [46.6 %]. The OPN balloon was used for pre-dilatation alone in 28.6 % (Pre-stent OPN group), post-dilatation alone in 63.2 % of lesions (Post-stent OPN group), and in both situations in 8.3 % of lesions with procedural success in 98.5 % of patients. Further dilatation with different NC balloons was required in both groups (30 %). The median (IQR) OPN balloon diameter in the pre- and post-stent OPN group were 2.5 (2.5, 3.0) and 3.0 (3.0,3.0) mm (p = 0.001), respectively. The difference between the diameter of the stent and OPN balloon used in pre-stent OPN group was 0.5 (0.2, 0.5) mm while it was 0.0 (0.0,0.2) mm in the post-stent OPN group (p < 0.001). Eight complications and two deaths occured. Distal shaft rupture was also noticed. CONCLUSION: OPN balloon is safe, and effective in treating calcified coronary lesions. We propose to undersize the balloon by 0.5 mm for pre-dilatation followed by 0.25 mm larger NC balloon if needed. In the post-dilatation group, use a 1:1 size balloon in a non-tortuous straight segment. Use imaging especially when (1) the pressure taken more than the rated burst pressure, (2) an OPN balloon size is ≥3 mm (3) using 1:1 size OPN balloon in a tortuous segment.

Procedural Safety and Long-Term Clinical Outcomes in Patients Receiving Ultra-Long Everolimus-Eluting Stent: A Single-Center Real-World Experience.

Background: Diffuse long coronary lesions are difficult to treat percutaneously. The aim of the present study was to assess the procedural safety and long-term efficacy of the ultra-long (48-mm) drug-eluting stent Xience Xpedition. Methods: This was an investigator-initiated, observational, all-comers study. A total of 92 patients with 93 lesions were enrolled in the study from October 2016 to October 2020. The primary outcome of the study was major adverse cardiac events (MACEs). Secondary outcomes were individual components of the primary outcome and procedural success. Results: The mean (standard deviation (SD)) age of the participants was 58.8 (10.8) years. More than half of the patients had ST-segment elevation myocardial infarction (STEMI) at presentation (55.4%). Ten patients were in cardiogenic shock (CGS; 10.8%). Most of the lesions were located in the left anterior descending artery (48.3%). American College of Cardiology/American Heart Association (ACC/AHA) type C was the most common lesion type amongst the intervened vessels (46.74%), with a mean syntax score (SD) of 16.99 (8.89). The mean stent diameter used was 2.77 mm (0.25). MACE was observed in 7.6% of patients studied at a median follow-up of 24 months. MACE was significantly lower in the population without CGS, occurring in only 2.4% of the patients; a significant difference in MACE was observed in patients with and without CGS (P < 0.001). Procedural success was obtained in 89.2% of total population; however, 96.3% of patients without CGS had procedural success. Conclusions: The deployment of the ultra-long 48-mm Xience Xpedition stent is feasible, safe, and effective; and it was associated with a good intermediate-term clinical outcome.

Clinical profile and management of patients with acute pulmonary thromboembolism - a single centre, large observational study from India.

Acute pulmonary thromboembolism is associated with high mortality, similar to that of myocardial infarction and stroke. We studied the clinical presentation and management of pulmonary thromboembolism in the Indian population. An analysis of 140 patients who presented with acute pulmonary thromboembolism at a large volume center in India from June 2015 through December 2018 was performed. The mean age of our study population was 50 years with 59% being male. Comorbidities including deep vein thrombosis, diabetes mellitus, hypertension, and chronic obstructive pulmonary disease were present in 52.9%, 40%, 35.7% and 7.14% of patients, respectively. Out of 140 patients, 40 (28.6%) patients had massive pulmonary thromboembolism, 36 (25.7%) sub-massive pulmonary thromboembolism, and 64 (45.7%) had low-risk pulmonary thromboembolism. Overall, in-hospital mortality was 25.7%. Multivariate regression analysis found chronic kidney disease and pulmonary thromboembolism severity to be the only independent risk factors. Thrombolysis was performed in 62.5% of patients with a massive pulmonary thromboembolism and 63.9% of patients with a sub-massive pulmonary thromboembolism. In the massive pulmonary thromboembolism group, patients receiving thrombolytic therapy had lower mortality compared with patients who did not receive therapy (p=0.022), whereas this difference was not observed in patients in the sub-massive pulmonary thromboembolism group. We conclude that patients with acute pulmonary thromboembolism in India presented more than a decade earlier than our western counterparts, and it was associated with poor clinical outcomes. Thrombolysis was associated with significantly reduced in-hospital mortality in patients with massive pulmonary thromboembolism.

Comparison of the effect of Morphine and Fentanyl in patients with acute coronary syndrome receiving Ticagrelor - The COMET (Comparison Morphine, Fentayl and Ticagrelor) randomized controlled trial.

INTRODUCTION: Dual antiplatelet therapy (DAPT) remains the cornerstone of acute coronary syndrome (ACS) management, and ticagrelor is one of the commonly used second antiplatelet agents. There is some evidence to suggest that morphine may reduce the antiplatelet effect of ticagrelor. METHODS AND RESULTS: In a single-center, randomized controlled trial, we compared the effect of morphine and fentanyl on platelet aggregation (PA) among patients with ACS treated with ticagrelor. Platelet aggregation was studied by automated light transmittance aggregometry (LTA) at baseline, and at 2 h after ticagrelor loading. The primary outcome was the difference in the maximal inhibition of platelet aggregation [IPA(%)] between the groups at 2 h. Pain relief, and drug-related adverse events were secondary outcomes. Of 136 patients randomized, 70 received fentanyl and 66 received morphine. At baseline, the median (IQR) platelet aggregation [61.35% (54.6 to 70) Vs. 58.8% (52.7 to 72.9)] were comparable between the groups. There was no statistically significant difference between the fentanyl and the morphine groups in IPA at 2-h [85.88%(64.65-98.16) and 81.93%(44.2-98.03), p = 0.09]. However, morphine use was independently associated with a PA of >30% at 2 h (p < 0.009). There was no difference in adverse events. CONCLUSION: In patients with ACS, there was no significant difference between the use of fentanyl or morphine on the effect of ticagrelor on PA. (CTRI/2018/04/013423).

Association of poor sleep quality with risk factors after coronary artery bypass graft surgery-A prospective cohort study.

Fragmented sleep is a daunting experience and a common health problem with high prevalence among patients 3 months after coronary artery bypass grafting (CABG). However, the potential predictors on poor seep quality remains unexplored. The main purpose of this study was to determine the predictors of poor sleep quality among patients 3 months after CABG. A prospective cohort study is a part of the randomized controlled trial between 2012 and 2013 in which 400 adult patients undergoing elective CABG were being randomly sampled as per the inclusion criteria followed up at 3 months after CABG surgery in the cardiovascular outpatient clinic of a tertiary-care hospital. The study was conducted according to the Declaration of Helsinki and was approved by the institutional ethical committee. All participants gave written informed consent on having received detailed information on the study. Demographic and clinical data were obtained from medical records at the time of CABG. The data on sleep quality were collected by using the Pittsburgh Sleep Quality Index and state anxiety was evaluated utilizing state-trait anxiety inventory (STAI-YI fo3rm). Multivariable logistic regression examined the association between the postoperative poor sleep quality and clinical, preoperative state anxiety, and angina. The significant variables are chosen based on the P-value associated with the significant level of model that lies on α = 0.05. Logit determination and the correlation between the variables are also discussed for further analysis. A total of 187 patients (mean age 55.6 ± 12.05 years) completed the questionnaire. Most patients (78%) reported poor sleep quality (4.23 ± 1.24) (PQSI score of less than 5). There was a strong relationship between PQSI and state anxiety. The higher state anxiety among 68% of patients with the mean score (53.51 ± 9.55) had 6.42 (95% CI 3.04-9.61) times the odds of being classified as high risk for sleep disturbance. There are 3 factors that most significant of the 8 factors tested were identified as having influence significantly on the poor sleep quality. These factors are diabetes (OR 1.186, 95% CI 1.016-1.097, P > .01), body mass index > 30 kg/m2 (OR 2.36, 95% CI 1.041-1.172, P > .05), sedentary lifestyle (OR 1.091, 95% CI 1.016-1.159, P > .01), and preoperative state anxiety (OR 1.186, 95% CI 1.074-1.115, P > .01). Even though the body mass index>30 kg/m2, sedentary lifestyle, and diabetes were significantly associated with sleep quality, the only factor with more significantly related to poor sleep quality was preoperative state anxiety which is the strong predictor of poor sleep quality. Hence, early recognition of predictors and careful management of poor sleep quality is warranted.