Safety and efficacy of the next generation Resolute Onyx zotarolimus-eluting stent: Primary outcome of the RESOLUTE ONYX core trial.

OBJECTIVES: To assess the safety and efficacy of the novel Resolute (R-) Onyx drug-eluting stent (DES). BACKGROUND: The R-Onyx DES consists of a composite wire with an outer shell of cobalt chromium alloy and a platinum-iridium inner core to enhance radiopacity, with thinner, swaged struts and modified stent geometry compared with the predicate Resolute DES, resulting in a slightly lower total drug load in most sizes. METHODS: This was a prospective, single-arm non-inferiority trial compared with a historical control. Patients with stable angina/ischemia and up to 2 de novo target lesions ≤35 mm long with reference vessel diameter (RVD) of 2.25-4.2 mm were enrolled. The primary endpoint was late lumen loss at 8-month follow-up. Propensity-score adjusted outcomes from the single-arm RESOLUTE-US trial served as the control. RESULTS: Seventy-five patients (85 lesions) were enrolled. Mean patient age was 66 ± 9 years, 73% were male, and 32% had diabetes. Mean lesion length was 14.28 ± 6.68 mm, mean RVD was 2.57 ± 0.48 mm, and 86% of lesions were class B2/C. In-stent late lumen loss at 8 months was 0.24 ± 0.39 mm with R-Onyx DES compared with 0.36 ± 0.52 mm with Resolute DES (P < 0.001 for noninferiority, P = 0.029 for superiority). At 8 months, clinically driven target lesion revascularization occurred in 3 patients (4.0%) and target lesion failure occurred in 5 patients (6.7%). CONCLUSIONS: In-stent late lumen loss is non-inferior, and appears to be superior, with the thin-strut novel composite wire R-Onyx DES compared with Resolute DES. Continued evolution of stent design can improve angiographic outcomes in complex lesions, even in the current era of next-generation DES.

Staging of multivessel percutaneous coronary interventions: an expert consensus statement from the Society for Cardiovascular Angiography and Interventions.

Percutaneous coronary interventions (PCIs) to treat multivessel coronary artery disease (MVCAD) may involve single-vessel or multivessel interventions, performed in one or more stages. This consensus statement reviews factors that may influence choice of strategy and includes six recommendations to guide decisions regarding staging of PCI. Every patient who undergoes PCI should receive optimal therapy for coronary disease, ideally before starting the procedure. Multivessel PCI at the time of diagnostic catheterization should be considered only if informed consent included the risks and benefits of multivessel PCI and the risks and benefits of alternative treatments. When considering multivessel PCI, the interventionist should develop a strategy regarding which stenoses to treat or evaluate, and their order, method, and timing. This strategy should maximize patient benefits, minimize patient risk, and consider the factors described in this article. For planned multivessel PCI, additional vessel(s) should be treated only if the first vessel is treated successfully and if anticipated contrast and radiation doses and patient and operator conditions are favorable. After the first stage of the planned multistage PCI, the need for subsequent PCI should be reviewed before it is performed. Third party payers and quality auditors should recognize that multistage PCI for MVCAD is neither an indication of poor quality nor an attempt to increase reimbursement when performed according to recommendations in this article.

Day-to-day blood pressure variability predicts poor outcomes following percutaneous coronary intervention: A retrospective study.

BACKGROUND: For patients with cardiovascular disease, blood pressure variability (BPV), distinct from hypertension, is an important determinant of adverse cardiac events. Whether pre-operative BPV adversely affects outcomes after percutaneous coronary intervention (PCI) is to this point unclear. AIM: To investigate the relationship between blood pressure variability and outcomes for patients post-PCI. METHODS: Patients undergoing PCI in a single state in 2017 were studied (n = 647). Systolic and diastolic BPV, defined as both the largest change and standard deviation for the 3-60 mo prior to PCI was calculated and patients with more than ten blood pressure measurements in that time were included for analysis (n = 471). Adverse outcomes were identified up to a year following the procedure, including major adverse cardiac events (MACE), myocardial infarction, cerebrovascular accident, death, and all-cause hospitalization. RESULTS: Visit-to-visit systolic BPV, as measured by both standard deviation and largest change, was higher in patients who had myocardial infarction, were readmitted, or died within one year following PCI. Systolic BPV, as measured by largest change or standard deviation, was higher in patients who had MACE, or readmissions (P < 0.05). Diastolic BPV, as measured by largest change, was higher in patients with MACE and readmissions (P < 0.05). CONCLUSION: As BPV is easily measured and captured in the electronic medical record, these findings describe a novel method of identifying at-risk patients who undergo PCI. Aggressive risk modification for patients with elevated BPV and known coronary artery disease is indicated.

Percutaneous approaches for retrieval of an embolized or malpositioned left atrial appendage closure device: A multicenter experience.

BACKGROUND: Experience with retrieval of a Watchman left atrial (LA) appendage (LAA) closure device (WD) is limited. An embolized or grossly malpositioned WD warrants retrieval to minimize the risk of thromboembolic complications and vascular occlusion. OBJECTIVE: The purpose of this study was to report approaches for percutaneous retrieval of a WD from multicenter experience. METHODS: Data on successful WD retrievals were obtained from high-volume operators. Data included clinical characteristics; structural characteristics of the LA and LAA; and procedural details of the deployment and retrieval procedure, type of retrieval (immediate: during the same procedure; delayed: during a separate procedure after the successful deployment), equipment used, complications, and postretrieval management. RESULTS: Ten successful percutaneous and 1 surgical retrievals comprised this study. Seven patients had immediate retrieval, while 4 had delayed retrieval. The median duration before delayed retrieval was 45 days (range 1-45 days). The median LAA diameter and size of a successfully deployed WD was 16 mm (range 14-24 mm) and 21 mm (range 21-30 mm), respectively. A WD was retrieved from the LA (n = 1), LAA (n = 2), left ventricle (n = 2), and aorta (n = 6). The reason for retrieval from the LAA was inadequate deployment, resulting in a significant peri-device leak. Retrieval from the LA or LAA was successfully performed using snares (n = 2) and a Raptor grasping device (n = 1). Retrieval from the left ventricle was achieved with a snare (n = 1) and surgery (n = 1). Retrieval from the aorta required snares (n = 5) and retrieval forceps (n = 1). Five patients were successfully reimplanted with a larger size WD. The only complication during percutaneous retrieval was a pseudoaneurysm. CONCLUSION: Retrieval of an embolized or malpositioned WD is feasible, and familiarity with snares and grasping tools can facilitate a successful removal.

The development or worsening of hypertension after transcatheter aortic valve replacement (TAVR) improves short-term and long-term patient outcomes.

OBJECTIVES: In patients with symptomatic aortic valve disease who are at intermediate to high risk for open surgical aortic valve replacement, transcatheter aortic valve replacement (TAVR) decreases overall mortality and improves quality of life. Hypertension (HTN) after TAVR has been associated with improved cardiac function and short-term survival but its effect on survival over 1 year is unclear. Our study aims to evaluate the effect of HTN following TAVR on short-term and long-term clinical and echocardiographic outcomes. METHODS: A retrospective chart review case-control study of 343 consecutive patients who underwent TAVR between August 2012 and November 2016 was performed to elucidate the relationship between HTN and post-TAVR outcomes. RESULTS: 193 patients who underwent TAVR (56.2%) developed or had a worsening of their HTN after TAVR. The development of post-TAVR HTN was associated with a significantly better overall survival at 1 year (89% vs 67%, p<0.001) and 2 years (72% vs 46%, p=0.002). Patients with increased blood pressure also had a significant lower in hospital cardiovascular mortality (1% vs 12%, p<0.001). However, the development or worsening of their HTN after TAVR was associated with an increase in heart failure (HF) exacerbations and diuretic use. CONCLUSIONS: The development or worsening of HTN after TAVR is associated with improved overall survival despite an increase in postprocedural HF exacerbations and antihypertensive medication utilisation. The outcomes of this study could be important in postoperative management of patients who underwent TAVR.

Rapid triage and transport of patients with ST-elevation myocardial infarction for percutaneous coronary intervention in a rural health system.

This study was conducted to evaluate door-to-treatment times before and after the implementation of a rapid triage and transfer system for patients with ST-elevation myocardial infarction transferred from community hospitals to a rural angioplasty center for primary percutaneous coronary intervention (PCI). The system was developed in late 2004 and implemented at a rural percutaneous coronary intervention center in early 2005. Helicopter transport was available for 97% of requests for transfer from community hospitals. All patients with ST-elevation myocardial infarction transferred during 2004 and 2005 (n=226) were evaluated with respect to presentation and treatment times. Time from community hospital presentation to wire crossing decreased during the study from 205 to 105 minutes (p=0.0001). One fourth of patients were treated <90 minutes after presentation, and 2/3 were treated in <120 minutes. In conclusion, the implementation of a rapid triage, transfer, and treatment protocol can achieve a significant shortening of presentation-to-treatment times. Efficient community hospitals working with an efficient angioplasty center can achieve presentation-to-wire crossing times of <90 minutes for some patients.

Telephone reporting in the consultant-generalist relationship.

RATIONALE, AIMS AND OBJECTIVES: The aim of this paper is to examine the issue of telephone reporting by consultants in the medical community, which is rarely used in medicine today. METHODS: The paper reviews principal publications addressing this field that have shown that communication between consultants and primary care physicians has many shortcomings, frequently leaving the primary care physician with unanswered questions. DISCUSSION AND CONCLUSIONS: We present the value of routine telephone reporting by consultants to their primary care counterparts and also discuss possible future implications of communication via electronic mail.

Door-to-balloon times under 90 min can be routinely achieved for patients transferred for ST-segment elevation myocardial infarction percutaneous coronary intervention in a rural setting.

OBJECTIVES: The purpose of this study was to demonstrate the feasibility of routine transfer of ST-segment elevation myocardial infarction (STEMI) patients to achieve percutaneous coronary intervention (PCI) in less than 90 min from presentation. BACKGROUND: Many PCI hospitals have achieved routine door-to-balloon times under 90 min for patients with STEMI presenting directly to the hospital. However, few patients transferred from a non-PCI center undergo PCI within 90 min of presentation. METHODS: Our rural PCI hospital implemented a program in 2005 for rapid triage, transfer, and treatment of STEMI patients and made additional improvements in 2006 and 2007. Intervals between milestones in the STEMI triage/transfer/treatment process were assessed before and after implementation of the program. RESULTS: During the 5-year study period, 676 patients with 687 STEMIs were transferred from 19 community hospitals and underwent PCI. Median door-to-balloon time decreased from 189 min to 88 min (p < 0.001). The time intervals reflecting efficiency of the referring hospitals, transfer services, and PCI hospital all significantly improved. In 2008, median door-to-balloon times were <90 min for 6 of the 7 most frequently referring hospitals. Delays during off-hours presentation in 2004 were abolished after the program was implemented in 2005. In-hospital mortality decreased from 6% before to 3% after implementation of the program. In multivariate modeling, presentation before initiation of the STEMI program predicted increased risk of in-hospital mortality (odds ratio: 3.74, 95% confidence interval: 1.22 to 11.51, p = 0.021). CONCLUSIONS: A program of rapid triage, transfer, and treatment of STEMI patients presenting to non-PCI hospitals can reduce in-hospital mortality and produce progressive improvements in door-to-balloon time such that median door-to-balloon times under 90 min are feasible.

The angiographic step-up and step-down: a surrogate for optimal stent expansion by intravascular ultrasound.

BACKGROUND: Standard high-pressure stent implantation frequently results in suboptimal stent expansion by intravascular ultrasound (IVUS) criteria. We aim to show that routine expansion of the stent to a diameter greater than the reference segment, leading to an angiographic step-up at the proximal stent edge and step-down at the distal stent edge, results in improved stent expansion. METHODS: We studied 25 patients undergoing coronary stent implantation. Twelve patients were randomized to standard sizing and 13 patients to step-up and step-down sizing as the angiographic goal. IVUS was then performed on all patients to detect incomplete stent strut apposition, dissection within the stent or a suboptimal stent expansion index (SEI). SEI was defined as the minimum stent area (MSA)/average reference lumen area x 100. Optimal SEI was defined as greater than or equal to 90% for a MSA less than or equal to 9.0 mm2 and greater than or equal to 80% for a MSA >9.0 mm2. RESULTS: Four patients (33%) treated with standard stent implantation and 12 patients (92%) treated with the step-up and step-down approach (p = 0.004) achieved optimal stent expansion. No patients in either group had unapposed stent struts or instent dissection on IVUS. There were no major adverse cardiac events on 6-month follow up. CONCLUSIONS: Stent deployment with an angiographic step-up and step-down approach improves the likelihood of optimal stent deployment by IVUS criteria as compared to the standard angiographic endpoint. This stenting technique is a simple and frugal alternative to IVUS-guided percutaneous coronary intervention, achieving very high rates of adequate stent apposition and expansion.