5-Year Outcomes of PCI Guided by Measurement of Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve.

BACKGROUND: Instantaneous wave-free ratio (iFR) is a coronary physiology index used to assess the severity of coronary artery stenosis to guide revascularization. iFR has previously demonstrated noninferior short-term outcome compared to fractional flow reserve (FFR), but data on longer-term outcome have been lacking. OBJECTIVES: The purpose of this study was to investigate the prespecified 5-year follow-up of the primary composite outcome of all-cause mortality, myocardial infarction, and unplanned revascularization of the iFR-SWEDEHEART trial comparing iFR vs FFR in patients with chronic and acute coronary syndromes. METHODS: iFR-SWEDEHEART was a multicenter, controlled, open-label, registry-based randomized clinical trial using the Swedish Coronary Angiography and Angioplasty Registry for enrollment. A total of 2,037 patients were randomized to undergo revascularization guided by iFR or FFR. RESULTS: No patients were lost to follow-up. At 5 years, the rate of the primary composite endpoint was 21.5% in the iFR group and 19.9% in the FFR group (HR: 1.09; 95% CI: 0.90-1.33). The rates of all-cause death (9.4% vs 7.9%; HR: 1.20; 95% CI: 0.89-1.62), nonfatal myocardial infarction (5.7% vs 5.8%; HR: 1.00; 95% CI: 0.70-1.44), and unplanned revascularization (11.6% vs 11.3%; HR: 1.02; 95% CI: 0.79-1.32) were also not different between the 2 groups. The outcomes were consistent across prespecified subgroups. CONCLUSIONS: In patients with chronic or acute coronary syndromes, an iFR-guided revascularization strategy was associated with no difference in the 5-year composite outcome of death, myocardial infarction, and unplanned revascularization compared with an FFR-guided revascularization strategy. (Evaluation of iFR vs FFR in Stable Angina or Acute Coronary Syndrome [iFR SWEDEHEART]; NCT02166736).

ß-blockers after myocardial infarction and 1-year clinical outcome - a retrospective study.

BACKGROUND: Long term ß-blocker therapy after myocardial infarction (MI) reduces mortality and recurrent MI but evidence for this treatment predates contemporary acute coronary care. ß-blocker treatment is a key quality of care indicator in the Swedish national quality register for acute coronary care, Riks-HIA. Between 2011 and 2015 a declining number of MI-patients discharged with a ß-blocker from the coronary care unit (CCU) at Helsingborg and other hospitals was reported. This retrospective observational study aimed to investigate the causes for discharge without a ß-blocker and relate it to outcome, compared to patients discharged with a ß-blocker. METHODS: MI-patients registered in Riks-HIA discharged without ß-blocker during 2011-2015 (no-ß-group) and a control group (ß-group) comprised of patients discharged with ß-blocker treatment between January 1 to December 31, 2013, were matched by RIKS-HIA criteria for ß-blocker use. Clinical characteristics, date of death, readmission for MI, other cardiovascular events were collected from Riks-HIA and medical records. RESULTS: The no-ß-group included 141 patients, where 65.2% had a justified reason for non-ß-blocker use. The ß-group included 206 patients. There was no difference in cardiovascular risk factor profile. There were a trend towards a higher number of readmissions for MI in the no-ß-group was (n = 8 (5.7%) vs n = 2 (1.0%), p = 0.02), but not mortality (6 (4.3%) vs 2 (1.0%), p = 0.07) and combined readmission for angina pectoris, heart failure, arrhythmias or stroke/TIA (n = 23 (16.3%) vs n = 25 (12.1%), p = 0.27). CONCLUSION: A majority of the patients in the no-ß-group had a justified absence of a ß-blocker. ß-blocker treatment post-MI showed a trend towards fewer readmissions for MI. But important quality information is lacking to make a firm conclusion of the effect on outcome.

[CCTA-derived FFR in clinical practise]. / Ny metod prövad för att minska behovet av invasiv koronarangiografi - Stenosgrad i kranskärl bedöms utifrån befintligt bildmaterial.

Coranary investigation with CCTA can depict coronary stenosis of high and low grade with high degree of accuracy, while intermediary stenosis on CTTA often needs complementary investigation with invasive coronary angiography. Simulated FFRCT analysis is a non-invasive evaluation of degree of stenosis of coronary vessels with a potential to reduce the number of invasive coronary angiography of intermediate stenosis. Helsingborg Hospital, together with HeartFlow Inc, is the first clinic in Sweden to have implemented simulated FFRCT analysis in clinical practice.

Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials.

BACKGROUND: The immunogenicity profile of the 9-valent HPV (9vHPV) vaccine was evaluated across five phase III clinical studies conducted in girls and boys 9-15 years of age and young women 16-26 years of age. The effect of baseline characteristics of subjects on vaccine-induced HPV antibody responses was assessed. METHODS: Immunogenicity data from 11,304 subjects who received ≥1 dose of 9vHPV vaccine in five Phase III studies were analyzed. Vaccine was administered as a 3-dose regimen. HPV antibody titers were assessed 1 month after dose 3 using a competitive Luminex immunoassay and summarized as geometric mean titers (GMTs). Covariates examined were age, gender, race, region of residence, and HPV serostatus and PCR status at day 1. RESULTS: GMTs to all 9 vaccine HPV types decreased with age at vaccination initiation, and were otherwise generally similar among the demographic subgroups defined by gender, race and region of residence. For all subgroups defined by race or region of residence, GMTs were higher in girls and boys than in young women. Vaccination of subjects who were seropositive at day 1 to a vaccine HPV type resulted in higher GMTs to that type, compared with those in subjects who were seronegative for that type at day 1. CONCLUSIONS: 9vHPV vaccine immunogenicity was robust among subjects with differing baseline characteristics. It was generally comparable across subjects of different races and from different regions. Greater immunogenicity in girls and boys versus young women (the population used to establish 9vHPV vaccine efficacy in clinical studies) indicates that the anti-HPV responses generated by the vaccine in adolescents from all races or regions were sufficient to induce high-level protective efficacy. This immunogenicity profile supports a widespread 9vHPV vaccination program and early vaccination.

Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCI.

BACKGROUND: The instantaneous wave-free ratio (iFR) is an index used to assess the severity of coronary-artery stenosis. The index has been tested against fractional flow reserve (FFR) in small trials, and the two measures have been found to have similar diagnostic accuracy. However, studies of clinical outcomes associated with the use of iFR are lacking. We aimed to evaluate whether iFR is noninferior to FFR with respect to the rate of subsequent major adverse cardiac events. METHODS: We conducted a multicenter, randomized, controlled, open-label clinical trial using the Swedish Coronary Angiography and Angioplasty Registry for enrollment. A total of 2037 participants with stable angina or an acute coronary syndrome who had an indication for physiologically guided assessment of coronary-artery stenosis were randomly assigned to undergo revascularization guided by either iFR or FFR. The primary end point was the rate of a composite of death from any cause, nonfatal myocardial infarction, or unplanned revascularization within 12 months after the procedure. RESULTS: A primary end-point event occurred in 68 of 1012 patients (6.7%) in the iFR group and in 61 of 1007 (6.1%) in the FFR group (difference in event rates, 0.7 percentage points; 95% confidence interval [CI], -1.5 to 2.8; P=0.007 for noninferiority; hazard ratio, 1.12; 95% CI, 0.79 to 1.58; P=0.53); the upper limit of the 95% confidence interval for the difference in event rates fell within the prespecified noninferiority margin of 3.2 percentage points. The results were similar among major subgroups. The rates of myocardial infarction, target-lesion revascularization, restenosis, and stent thrombosis did not differ significantly between the two groups. A significantly higher proportion of patients in the FFR group than in the iFR group reported chest discomfort during the procedure. CONCLUSIONS: Among patients with stable angina or an acute coronary syndrome, an iFR-guided revascularization strategy was noninferior to an FFR-guided revascularization strategy with respect to the rate of major adverse cardiac events at 12 months. (Funded by Philips Volcano; iFR SWEDEHEART ClinicalTrials.gov number, NCT02166736 .).

Minor Cytological Abnormalities and up to 7-Year Risk for Subsequent High-Grade Lesions by HPV Type.

OBJECTIVE: Diagnoses of atypical squamous cells of undetermined significance (ASCUS) and low-grade squamous intraepithelial lesions (LSIL) are common, but the corresponding risk of disease varies by human papillomavirus (HPV) status, complicating management strategies. Our aim was to estimate the longer-term risk of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) among women with ASCUS/LSIL by age, HPV status, and genotype(s). METHODS: A total of 314 women with ASCUS/ LSIL were followed for a median of 3.8 years. Baseline HPV status was determined by reflex testing and women with histologically confirmed CIN2+ were identified through linkage to the Swedish National Quality Register for Cervical Cancer Prevention. Cumulative incidence and hazard ratios were estimated to explore differences between index data and associations with CIN2+. RESULTS: In total, 89 women (28.3%) developed CIN2+. High-risk (HR) HPV-positive women developed significantly more CIN2+ than HR-HPV-negative women (cumulative incidence 3.5 years after the index test: 42.2%, 95% CI: 32.5-53.5 for HPV16/18; 36.2%, 95% CI: 28.3-45.4 for other HR-HPV types; and 2.0%, 95% CI: 0.5-7.8 for HR-HPV-negative women; p<0.0001). CONCLUSION: HPV status was of greatest importance in determining the risk of CIN2+. The risk was low among HPV-negative women during the first years of follow-up, suggesting these women could be followed less intensively. HPV16/18-positive women may need intensified follow-up as they showed the highest risk of CIN2+.

Thrombotic occlusion of all left coronary branches in a young woman with severe ulcerative colitis.

Background. The thrombosis risk is increased in active ulcerative colitis. The limited number of reported complications have predominantly been cerebrovascular but other vessel territories may also be affected. Patient. During a severe attack of ulcerative colitis a 37-year-old woman suffered occlusion of all left coronary artery branches. Serial angiographies showed progressive recanalisation of the coronary arteries during anticoagulation, but no atherosclerotic stenosis. The cause of infarction was thus considered to be an extensive coronary thrombosis. However, a large battery of blood tests failed to identify any procoagulant abnormality. Conclusion. Evidence is now accumulating that the increased thrombosis risk also may involve the coronary arteries, even in young patients. To the best of our knowledge this is the third reported case of myocardial infarction despite angiographically normal coronary arteries in a patient with active ulcerative colitis. The extent of affected myocardium was in this case exceptionally large.

Decision support for the initial triage of patients with acute coronary syndromes.

Early revascularization of acute coronary syndromes improves the prognosis. It is of vital importance that the decision to treat the patient is taken as early as possible. The aim of this study was (i) to develop an automated tool for the analysis of electrocardiograms (ECGs) with regard to changes that indicate possible transmural ischaemia and (ii) to assess the influence of the tool on the ECG classifications of three interns with less than 12 months of experience in ECG reading. An artificial neural network was trained to automatically interpret ECGs using 3000 ECGs recorded at an emergency department. Thereafter, the performance of the network was evaluated using 1000 test ECGs. In the second step, three interns classified these test ECGs twice on different occasions, with and without the advice of the neural network. The gold standard was the classification made by two experienced cardiologists. On average, the three interns showed a sensitivity of 68% at a specificity of 92% without the advice of the neural network and a sensitivity of 93% at a specificity of 87% with the advice. The neural network itself showed a sensitivity of 95% at a specificity of 88%. The increase in sensitivity of 23-26% was significant (P<0.001) for all three interns. In conclusion, an artificial neural network can be trained to the improve performance in the interpretation of ST-segment changes in accordance with that of the experienced cardiologists.

Successful resuscitation with mechanical CPR, therapeutic hypothermia and coronary intervention during manual CPR after out-of-hospital cardiac arrest.

A 62-year-old man suffered out-of-hospital cardiac arrest and was treated with mechanical compression-decompression during transport to the hospital. In the emergency department, 28 min after cardiac arrest, spontaneous circulation returned briefly but the patient rapidly became asystolic and mechanical compression-decompression was again applied. After further resuscitation a spontaneous circulation returned and the patient was transferred, deeply comatose, to the coronary intervention laboratory while therapeutic hypothermia was induced. In the laboratory the heart arrested again and coronary angiography was performed during manual CPR revealing a left main stem occlusion. After successful reperfusion of the heart the patient was transferred to the intensive care unit with an intra-aortic balloon pump. The patient was treated with hypothermia for 24 h and awoke without neurological sequelae after a sustained intensive care period of 13 days. The present case is an example of how modern resuscitation principles implementing new clinical and experimental findings may strengthen the chain of survival during resuscitation.

Neural networks--a diagnostic tool in acute myocardial infarction with concomitant left bundle branch block.

The prognosis of acute myocardial infarction (AMI) improves by early revascularization. However the presence of left bundle branch block (LBBB) in the electrocardiogram (ECG) increases the difficulty in recognizing an AMI and different ECG criteria for the diagnosis of AMI have proved to be of limited value. The purpose of this study was to detect AMI in ECGs with LBBB using artificial neural networks and to compare the performance of the networks to that of six sets of conventional ECG criteria and two experienced cardiologists. A total of 518 ECGs, recorded at an emergency department, with a QRS duration > 120 ms and an LBBB configuration, were selected from the clinical ECG database. Of this sample 120 ECGs were recorded on patients with AMI, the remaining 398 ECGs being used as a control group. Artificial neural networks of feed-forward type were trained to classify the ECGs as AMI or not AMI. The neural network showed higher sensitivities than both the cardiologists and the criteria when compared at the same levels of specificity. The sensitivity of the neural network was 12% (P = 0.02) and 19% (P = 0.001) higher than that of the cardiologists. Artificial neural networks can be trained to detect AMI in ECGs with concomitant LBBB more effectively than conventional ECG criteria or experienced cardiologists.