Midterm Outcomes in Patients With Aortic Stenosis Treated With Contemporary Balloon-Expandable and Self-Expanding Valves: Does Valve Size Have an Impact on Outcome?

Background No data currently exist comparing the contemporary iterations of balloon-expandable (BE) Edwards SAPIEN 3/Ultra and the self-expanding (SE) Medtronic Evolut PRO/R34 valves. The aim of the study was the comparison of these transcatheter heart valves with emphasis on patients with small aortic annulus. Methods and Results In this retrospective registry, periprocedural outcomes and midterm all-cause mortality were analyzed. A total of 1673 patients (917 SE versus 756 BE) were followed up for a median of 15 months. A total of 194 patients died (11.6%) during follow-up. SE and BE groups showed similar survival at 1 (92.6% versus 90.6%) and 3 (80.3% versus 85.2%) years (Plog-rank=0.136). Compared with the BE group, patients treated with the SE device had lower peak (16.3±8 mm Hg SE versus 21.9±8 mm Hg BE) and mean (8.8±5 mm Hg SE versus 11.5±5 mm Hg BE) gradients at discharge. Conversely, the BE group demonstrated lower rates of at least moderate paravalvular regurgitation postoperatively (5.6% versus 0.7% for SE and BE valves, respectively; P<0.001). In patients treated with small transcatheter heart valves (≤26 mm for SE and ≤23 mm for BE; N=284 for SE and N=260 for BE), survival was higher among patients treated with SE valves at both 1 (96.7% SE versus 92.1% BE) and 3 (91.8% SE versus 82.2% BE) years (Plog-rank=0.042). In propensity-matched patients treated with small transcatheter heart valve, there remained a trend for higher survival among the SE group at both 1 (97% SE versus 92.3% BE) and 3 years (91.8% SE versus 78.7% BE), Plog-rank=0.096). Conclusions Real-world comparison of the latest-generation SE and BE devices demonstrated similar survival up to 3 years' follow-up. In patients with small transcatheter heart valves, there may be a trend for improved survival among those treated with SE valves.

Validation of the MIRACLE2 Score for Prognostication After Out-of-hospital Cardiac Arrest.

Background: Out-of-hospital cardiac arrest (OHCA) is associated with very poor clinical outcomes. An optimal pathway of care is yet to be defined, but prognostication is likely to assist in the challenging decision-making required for treatment of this high-risk patient cohort. The MIRACLE2 score provides a simple method of neuro-prognostication but as yet it has not been externally validated. The aim of this study was therefore to retrospectively apply the score to a cohort of OHCA patients to assess the predictive ability and accuracy in the identification of neurological outcome. Methods: Retrospective data of patients identified by hospital coding, over a period of 18 months, were collected from a large tertiary-level cardiac centre with a mature, multidisciplinary OHCA service. MIRACLE2 score performance was assessed against three existing OHCA prognostication scores. Results: Patients with all-comer OHCA, of presumed cardiac origin, with and without evidence of ST-elevation MI (43.4% versus 56.6%, respectively) were included. Regardless of presentation, the MIRACLE2 score performed well in neuro-prognostication, with a low MIRACLE2 score (≤2) providing a negative predictive value of 94% for poor neurological outcome at discharge, while a high score (≥5) had a positive predictive value of 95%. A high MIRACLE2 score performed well regardless of presenting ECG, with 91% of patients receiving early coronary angiography having a poor outcome. Conclusion: The MIRACLE2 score has good prognostic performance and is easily applicable to cardiac-origin OHCA presentation at the hospital front door. Prognostic scoring may assist decision-making regarding early angiographic assessment.

Time to TAVI: streamlining the pathway to treatment.

INTRODUCTION: Severe aortic stenosis is a major cause of morbidity and mortality. The existing treatment pathway for transcatheter aortic valve implantation (TAVI) traditionally relies on tertiary Heart Valve Centre workup. However, this has been associated with delays to treatment, in breach of British Cardiovascular Intervention Society targets. A novel pathway with emphasis on comprehensive patient workup at a local centre, alongside close collaboration with a Heart Valve Centre, may help reduce the time to TAVI. METHODS: The centre performing local workup implemented a novel TAVI referral pathway. Data were collected retrospectively for all outpatients referred for consideration of TAVI to a Heart Valve Centre from November 2020 to November 2021. The main outcome of time to TAVI was calculated as the time from Heart Valve Centre referral to TAVI, or alternative intervention, expressed in days. For the centre performing local workup, referral was defined as the date of multidisciplinary team discussion. For this centre, a total pathway time from echocardiographic diagnosis to TAVI was also evaluated. A secondary outcome of the proportion of referrals proceeding to TAVI at the Heart Valve Centre was analysed. RESULTS: Mean±SD time from referral to TAVI was significantly lower at the centre performing local workup, when compared with centres with traditional referral pathways (32.4±64 to 126±257 days, p<0.00001). The total pathway time from echocardiographic diagnosis to TAVI for the centre performing local workup was 89.9±67.6 days, which was also significantly shorter than referral to TAVI time from all other centres (p<0.003). Centres without local workup had a significantly lower percentage of patients accepted for TAVI (49.5% vs 97.8%, p<0.00001). DISCUSSION: A novel TAVI pathway with emphasis on local workup within a non-surgical centre significantly reduced both the time to TAVI and rejection rates from a Heart Valve Centre. If adopted across the other centres, this approach may help improve access to TAVI.

The uroguanylin system and human disease.

The uroguanylin system is a newly discovered endocrine/paracrine system that may have a role in the regulation of salt balance, appetite and gut health. The precursor pro-uroguanylin is predominantly synthesized in the gut, although there may be other sites of synthesis, including the kidney tubules. Products from pro-uroguanylin may mediate natriuresis following oral consumption of a salt load through both GC-C (guanylate cyclase C)-dependent and -independent mechanisms, and recent evidence suggests a role in appetite regulation. Local paracrine effects in the gut through GC-C stimulation may have tumour-suppressing actions through the regulation of cell proliferation and metabolism. Although most information on this system has been derived from knockout models, recent human studies have indicated possible roles in heart failure and renal failure. An improved understanding of the nature of its natriuretic, appetite and tumour-suppressing actions may facilitate the discovery of new therapies for heart failure, obesity and cancer prophylaxis.

Meta-Analysis Comparing Percutaneous to Surgical Access in Trans-Femoral Transcatheter Aortic Valve Implantation.

To compare the outcomes in trans-femoral transcatheter aortic valve implantation (TF-TAVI) performed with percutaneous approach (PC) versus surgical cut-down (SC). In 13 trials including 5,859 patients (PC = 3447, SC = 2412), the outcomes based on Valve Academic Research Consortium criteria were compared between PC and SC in TF-TAVI. Compared with SC, PC was associated with similar major vascular complications (VCs) (8.7% vs 8.5%; odds ratio [OR] = 0.93, 95% confidence interval [CI] = 0.76 to 1.15, p = 0.53), major bleeding (OR = 1.09, 95% CI = 0.66 to 1.8, p = 0.73), perioperative mortality (5.7% vs 5.2%; OR = 1.13, 95% CI = 0.85 to 1.49, p = 0.4), urgent surgical repair (OR = 1.27, 95% CI = 0.81 to 2.02, p = 0.3), stroke (3.3% vs 3.9%; OR = 0.85, 95% CI = 0.53 to 1.36, p = 0.5), myocardial infarction (1.3% vs 1.1%; OR = 1.06, 95% CI = 0.53 to 2.12, p = 0.86), and renal failure (5.2% vs 5.9%; OR = 0.68, 95% CI = 0.38 to 1.22, p = 0.2), but shorter hospital stay (9.1 ± 8.5 vs 9.6 ± 9.5 days; mean difference = -1.07 day, 95% CI = -2.0 to -0.15, p = 0.02) and less blood transfusion (18.5% vs 25.7%; OR = 0.61, 95% CI = 0.43-0.86, p = 0.005). Minor VCs occurred more frequently in PC compared to SC (11.9% vs 6.9%; OR = 1.67, 95% CI = 1.04-2.67, p = 0.03). In conclusion, in TF-TAVI, PC is a safe and feasible alternative to SC, and adopting either approach depends on operator experience after ensuring that vascular access could be safely achieved with that specific technique.

Bivalirudin versus heparin in primary PCI: clinical outcomes and cost analysis.

Background: The evidence for benefits of bivalirudin over heparin has recently been challenged. We aimed to analyse the safety and cost-effectiveness following reintroduction of heparin instead of bivalirudin as the standard anticoagulation for primary percutaneous coronary intervention (PPCI) in a high-volume centre. Methods and results: This analysis was an open-label, prospective registry including all patients admitted to our centre for PPCI from April 2014 to April 2016. Heparin was reintroduced as standard anticoagulant in April 2015. During the 2 years, 1291 patients underwent a PPCI, 662 in the Bivalirudin protocol period (Cohort B) and 629 in the Heparin protocol period (Cohort H). Baseline and procedural characteristics were not significantly different, except for a higher use of thromboaspiration and femoral access in the earlier Cohort B. Glycoprotein 2b3a (Gp2b3a) antagonists were used in 24% of the patients in Cohort B versus 28% in Cohort H (P<0.01). We did not observe any differences in death at 180 days (11.03% in Cohort B vs 11.29% in Cohort H)(HR 95% CI 0.98 (0.72 to 1.33), P=0.88). The incidence of any bleeding complications at 30 days did not differ between the two periods (21.9% vs 21.9%, P=0.99). The cost related to the anticoagulants amounted to £246 236 in Cohort B versus £4483 in Cohort H (£324 406 vs £102 347 when adding Gp2b3a antagonists). Conclusion: We did not find clinically relevant changes in patient outcomes, including bleeding complications with reintroduction of heparin in our PPCI protocol. However, the use of heparin was associated with a major reduction in treatment costs.

A systematic review of population-based studies of infective endocarditis.

BACKGROUND: We sought to summarize and critically appraise the literature on the epidemiology of infective endocarditis (IE) in the general population. METHODS: We retrieved population-based IE surveys by searching MEDLINE and EMBASE. Two reviewers independently extracted relevant data. We performed a metaregression to determine if temporal trends of IE characteristics exist. RESULTS: Fifteen population-based investigations with 2,371 IE cases from seven countries (Denmark, France, Italy, the Netherlands, Sweden, United Kingdom, and United States) from 1969 to 2000 were eligible. Different case definitions and procedures were used to capture all IE cases, including census of existing diagnoses, record-linkage system, and direct contact survey. In the unadjusted regression, there was a decline in the proportion of IE patients with underlying rheumatic heart disease (RHD; 12%; 95% confidence interval [CI], - 21 to - 3%; p = 0.01) and an increase in the proportion of patients undergoing valve surgery (9%; 95% CI, 3 to 16%) per decade. After adjusting for country, the decline in IE cases with underlying RHD became nonsignificant, but the proportions of IE patients undergoing valve surgery increased 7% per decade (95% CI, - 4 to 14%; p = 0.06), and those with underlying prosthetic valve increased 7% per decade (95% CI, - 1 to 16%; p = 0.07). There were no significant temporal trends in the causative organisms. CONCLUSION: Evidence from well-planned, representative IE epidemiologic surveys is scarce in many countries. Available studies suggest a changing distribution of underlying valvular heart disease in patients with IE and an increase in its surgical treatment.

Single-centre experience of STENTYS Xposition S in treatment of left main stem lesions.

BACKGROUND: The second generation STENTYS Xposition S self-expanding stent with a novel balloon delivery system was launched in May 2015. The stents unique properties are well suited for the treatment of left main stem disease where large diameters, coverage of diameter differences and precise positioning are required. We report the first consecutive experience of using this device in the treatment of left main stem lesions. METHODS: 20 consecutive patients with a mean age of 73.9±10.1 years were treated over a period of 8 months at our institution and were assessed on the parameters of technical, angiographic and procedural success. RESULTS: Technical success was achieved in 95% of cases and angiographic success in 80% of cases. There was no incidence of geographical miss. Side branch access was straightforward, with no failure to recross stent struts, dilate or deploy a second stent if required. In this unselected clinical cohort, 2 critically ill patients with cardiogenic shock on presentation died despite successful revascularisation. There was no incidence of early stent related complications up to 30-day follow up. CONCLUSION: This first consecutive series of left main lesions treated with STENTYS Xposition S documents high acute technical and procedural success rates.

Optimizing adjunctive antithrombotic and anticoagulant therapy in primary PCI for STEMI.

The pharmacological management of patients with ST elevation myocardial infarction (STEMI) poses a significant challenge to the clinician. While mechanical reperfusion with primary percutaneous coronary intervention (PPCI) has proved its superiority over fibrinolysis, the best antithrombotic strategy surrounding the procedure remains a matter of debate. Due to the high risk of bleeding induced by antithrombotic drugs, the pharmacological management of STEMI needs to focus on an optimal strategy that reduces the rate of coronary thrombotic events without leading to excess bleeding. Intravenous anticoagulants are recommended for all patients presenting with STEMI. Low molecular heparin may be preferred over unfractionated heparin in the setting of PPCI. Recent data suggest that anticoagulation with bivalirudin can be utilized as an alternative strategy to heparin and Gp2b3a but this should be limited to patients at high risk of bleeding. Dual antiplatelet therapy comprising aspirin and P2Y12 inhibitor represents the cornerstone treatment for STEMI. New P2Y12 inhibitors (prasugrel and ticagrelor) have restricted clopidogrel use to situations where these potent agents are contraindicated. Whilst all oral antiplatelet agents have been used with an initial loading dose in STEMI, the time of their administration remains a controversial issue. In everyday practice, intravenous antiplatelet agents appear less consensual. While Gp2b3a receptor inhibitors use has been restricted to bailout situations, the place of cangrelor is not yet defined in real life daily practice.

Complex cardiac pacing in the setting of a district general hospital: procedural success and complications.

BACKGROUND AND PURPOSE: Complex cardiac pacing with either an implantable cardiovertor defibrillator (ICD) or a biventricular pacemaker with pacing only (CRT-P) or biventricular pacemaker with implantable cardiovertor defibrillator (CRT-D) plays an important role in the management of patients with heart failure. However, device implantation is associated with rare but significant complications which may limit the number of centres offering this treatment. The aim of this study is to define procedural success and complication rates associated with implantation of complex implantable cardiac devices in a district general hospital. METHODS AND SUBJECTS: The pacing records of all the patients who underwent complex cardiac pacing (ICD, CRT-P and CRT-D) between January 2010 and December 2011 were reviewed. Information on clinical characteristics, pacing indications, venous access, implantation data, lead stability at follow-up, and procedure-related complications were obtained. RESULTS: A total of 151 devices (60 CRT-Ds, 55 CRT-Ps and 36 ICDs), were implanted between January 2010 and December 2011 with a median follow-up of 12 months. Overall transvenous procedural success rate was 99.3%. 14 (9.3%) out of the 151 patients suffered a complication. There were no procedure-related deaths, and lead displacement (5.3%) was the most common complication. Other complications included pocket haematoma and phrenic nerve stimulation (1.3% and 3.4%, respectively). There were no cases of pneumothorax, cardiac tamponade, device-related infection, symptomatic venous thrombosis and stroke. Lead thresholds, in particular that of the left ventricular lead, remained stable during the follow-up period indicating persistent delivery of cardiac resynchronisation therapy in the group receiving CRT systems. CONCLUSIONS: In the presence of necessary clinical expertise, complex cardiac devices can be implanted successfully and with a high degree of safety in the setting of a district general hospital.