30-Day and 1-Year Outcomes With HYDRA Self-Expanding Transcatheter Aortic Valve: The Hydra CE Study.

OBJECTIVES: This study sought to evaluate the 30-day and 1-year safety and performance of the Hydra transcatheter aortic valve (THV) (in the treatment of symptomatic severe aortic stenosis in patients at high or extreme surgical risk. BACKGROUND: The Hydra THV is a novel repositionable self-expanding system with supra-annular bovine pericardial leaflets. METHODS: The Hydra CE study was a premarket, prospective, multicenter, single-arm study conducted across 18 study centers in Europe and Asia-Pacific countries. The primary endpoint was all-cause mortality at 30 days. All endpoints were adjudicated by an independent clinical events committee. RESULTS: A total of 157 patients (79.2 ± 7.1 years of age, 58.6% female; Society of Thoracic Surgeons score 4.7 ± 3.4%) were enrolled. Successful implantation was achieved in 94.3% cases. At 30 days, there were 11 (7.0%) deaths, including 9 (5.7%) cardiovascular deaths, of which 5 (3.2%) were device related. At 1 year, there were 23 (14.6%) deaths, including 13 (8.3%) cardiovascular deaths. At 30 days, there were significant improvement of effective orifice area (from 0.7 ± 0.2 cm2 to 1.9 ± 0.6 cm2) and mean aortic valve gradient (from 49.5 ± 18.5 mm Hg to 8.1 ± 3.7 mm Hg), which were sustained up to 1 year. Moderate or severe paravalvular leak was observed in 6.3% of patients at 30 days and 6.9% of patients at 1 year. The rate of new permanent pacemaker implantation was 11.7% at 30 days and 12.4% at 1 year. CONCLUSIONS: The Hydra CE study demonstrated that transcatheter aortic valve replacement with Hydra THV offered favorable efficacy at 1 year, providing large effective orifice area and low transvalvular gradient as well as acceptable complication rates with regard to new permanent pacemaker and paravalvular leak. (A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve; NCT02434263).

Short term clinical outcomes and analysis of risk factors for pacemaker implantation: a single center experience of self-expandable TAVI valves.

OBJECTIVES: Transcatheter aortic valve implantation is a recognized treatment for patients with severe aortic stenosis at all risk groups. However, permanent pacemaker rates remain high for self expandable transcatheter valves and permanent pacemaker implantation has been associated with increased morbidity. In this analysis we aim to evaluate short term clinical outcomes post self expandable transcatheter aortic valve implantation and determine risk factors for permanent pacemaker implantation. METHODS: 88 patients with severe aortic stenosis with transcatheter aortic valve implantation performed between the year 2016-2018 were retrospectively analyzed. Outcomes of interest included 1- year all cause mortality, 30-day major adverse cardiovascular events, permanent pacemaker and paravalvular leak rates. Survival analysis was performed with Kaplan Meier analysis and risk factors for survival and permanent pacemaker rates were identified with log rank test and regression analysis. RESULTS: The mean age of the cohort was 80.3 +/- 6.9 years. The mean STS score was 9.25. The 30 day all-cause mortality was 5.7% and 1-year all cause mortality was 16.7%. 80 patients had transfemoral transcatheter aortic valve implantation, and a majority of the patients (85.2%) were implanted with Corevalve Evolut R device. The device success rate was 88.6%. Multivariate analysis identified concomitant severe coronary artery disease (OR = 18.2 +/- 0.9; P = 0.002), pre transcatheter aortic valve implantation atrial fibrillation (OR = 8.6 +/- 0.91; P = 0.02) and post procedural disabling stroke (OR = 32.6 +/- 1.35; P = 0.01) as risk factors for 1-year mortality. The 30-day pacemaker rate was 17.6%. The presence of right bundle branch block (OR 11.1 +/- 0.86; P = 0.005), non-coronary cusp implantation depth (OR = 1.34 +/- 0.15; P = 0.05) and a non coronary cusp implantation depth / membranous septal length ratio of more than 50% were associated with post procedural pacemaker implantation (OR = 29.9 +/- 1.72; P = 0.05). Among the 15 patients with post procedural pacemaker implantation, 40% were found to be non-pacemaker dependent at 1 year. CONCLUSION: Short term outcomes of transcatheter aortic valve implantation in severe aortic stenosis patients are promising. Pacemaker rates remain high. More studies are needed to evaluate the factors that influence pacemaker rates and dependence to further improve transcatheter aortic valve implantation outcomes.

Application of Cerebral Protection System in Open Mitral Replacement with Extensive Calcified Left Atrial Thrombus.

Neurological complications remain a major burden in cardiac surgery, despite various intraoperative measures attempting to reduce its occurrence. Advancement of percutaneous approach in valve replacement has brought focus to the use of cerebral protection system (CPS). We reported a novel application of percutaneous CPS in open heart surgery for a patient with an extensive calcified left atrial thrombus to reduce risk of embolic stroke. Although, there is no evidence to advocate routine use of CPS in all open cardiac surgical patients, we believe it is a technically feasible and probably safe approach for neurological protection in high-risk patients.

Aspirin desensitisation for Chinese patients with coronary artery disease.

OBJECTIVE. To assess the efficacy and safety of aspirin desensitisation in Chinese patients with coronary artery disease. DESIGN. Case series. SETTING. A regional hospital in Hong Kong. PATIENTS. Chinese patients with coronary artery disease and a history of a hypersensitivity reaction to aspirin or non-steroidal anti-inflammatory drug, who underwent aspirin desensitisation between February 2008 and July 2012. RESULTS. There were 24 Chinese patients with coronary artery disease who were admitted to our unit for aspirin desensitisation during this period. The majority (79%) were clinical admissions for desensitisation; eight (33%) of them developed a hypersensitivity reaction during desensitisation. Half of the latter had only limited cutaneous reactions and were able to complete the desensitisation protocol and developed aspirin tolerance. Overall, 20 (83%) of the patients were successfully desensitised at the initial attempt. No serious adverse reactions occurred in the cohort. Twelve of the patients had significant coronary artery disease revealed by coronary angiography and received a percutaneous coronary intervention, nine of whom received drug-eluting stents while three received bare metal stents due to financial constraints. All 11 successfully desensitised patients received aspirin and clopidogrel as double antiplatelet therapy after percutaneous coronary intervention. The remaining patient had a bare metal stent implant due to failed aspirin desensitisation. CONCLUSION. Given the potentially different genetic basis of aspirin hypersensitivity in different ethnicities, recourse to desensitisation in the Chinese population has not previously been addressed. This study demonstrated that aspirin desensitisation using a rapid protocol can be performed effectively and safely in Chinese patients. Our results were comparable to those in other reported studies involving other ethnicities. Successful aspirin desensitisation permits patients to pursue long-term double antiplatelet therapy that includes aspirin after percutaneous coronary intervention, and thus allows the use of drug-eluting stents as a feasible option.

Jeopardised Inferior Myocardium (JIM) score: an arithmetic electrocardiographic score to predict the infarct-related artery in inferior myocardial infarction.

INTRODUCTION: A few electrocardiographic criteria have been described to identify the infarct-related artery in inferior myocardial infarction. The aim of this study was to devise an arithmetic score to further improve the diagnostic accuracy. MATERIALS AND METHODS: From 2004 to 2006, 78 patients who underwent primary angioplasty for inferior myocardial infarction within 6 hours from symptom onset were recruited for electrocardiographic and angiographic analysis. RESULTS: The mean age of patients was 65 ± 12 years with male predominance (74%). Less ST depression in lead I and aVL, and more prominent ST depression in lead V1-3 were observed in left circumflex artery (LCX) than right coronary artery (RCA) occlusions. In addition, more prominent ST depression in lead I and ST elevation in V1 were found in proximal RCA than distal RCA occlusions. Based on the findings, the Jeopardised Inferior Myocardium (JIM) score was constructed and defi ned as [II-V3/III+V1- I]. The sensitivity and specificity of JIM score ≤0.5 to predict proximal RCA occlusions; 0.5 1.5 to predict LCX occlusions were 58% and 85%, 69% and 68%, and 79% and 94%, respectively. The accuracy of prediction is slightly better than the 2 previously reported criteria. CONCLUSION: By taking into account more leads, the JIM score is capable of identifying the infarct-related artery with an improved diagnostic accuracy.

Primary percutaneous coronary intervention for ST elevation myocardial infarction: performance with focus on timeliness of treatment.

OBJECTIVE: To review primary percutaneous coronary interventions performed for patients with ST elevation myocardial infarction with a focus on door-to-treatment time, especially after introduction of a new management programme in November 2003. DESIGN: Retrospective study. SETTING: Regional hospital, Hong Kong. PATIENTS: All patients with ST elevation myocardial infarction who underwent primary percutaneous coronary intervention in our hospital from January 2002 to December 2007. RESULTS: In all, 209 patients with ST elevation myocardial infarction had primary percutaneous coronary interventions between January 2002 and December 2007; 140 of them were admitted within office hours, 125 of whom came directly from Accident and Emergency Department. The mean door-to-balloon time of these patients was 115 minutes, and in 41% the time was less than 90 minutes (as recommended by the American College of Cardiology/American Heart Association guidelines). Since introduction of the new programme, the mean door-to-balloon time has diminished significantly, from 146 to 116 minutes (P=0.047). Delay in diagnosis (28%) and Cardiac Catheterization Laboratory being occupied (20%) were the two most common reasons for prolonged door-to-balloon times. CONCLUSION: We achieved satisfactory performance in our primary percutaneous coronary intervention programme, providing timely reperfusion therapy for patients with ST elevation myocardial infarction. A well-organised and systematic clinical pathway is a prerequisite for a centre that provides a timely and effective primary percutaneous coronary intervention service for patients with ST elevation myocardial infarction. Better public education and greater awareness on the part of medical service providers are needed, so as to facilitate urgent revascularisation and improve outcomes in patients with ST elevation myocardial infarction.