INTRODUCTION:The prevalence of bioprosthetic aortic valve failure is increasing due to the broader use of bioprosthetic valves, both surgical and transcatheter, and an ageing population. Registry data indicate a higher risk of coronary obstruction and elevated gradients following valve-in-valve transcatheter aortic valve implantation (TAVI). We report outcomes of the Allegra transcatheter heart valve system in valve-in-valve TAVI. METHODS:In this retrospective multicentre cohort study, all patients undergoing valve-in-valve TAVI with the Allegra system between 2019 and 2025 at five UK centers were included. The combined primary outcomes were technical success, device success, and early safety at 30 days, as per the VARC-3 (Valve Academic Research Consortium-3) criteria. A key secondary outcome was all-cause mortality at the longest documented follow-up. RESULTS:A total of 106 patients underwent valve-in-valve TAVI. The mean age was 79 ± 6 years, with 57.5% being female. Almost half of the patients had an index valve ≤ 21 mm, with an STS (Society of Thoracic Surgery) score of 7.1% (5.1-12.0). The post-implant aortic valve mean pressure gradient was 12 ± 6 mmHg, and the mean valve area was 1.7 ± 0.5 cm2. The combined primary outcomes were technical success of 86.8% (CI 80.3%-93.2%), device success of 75.5% (CI 67.3%-83.7%), and early safety of 86.8% (CI 80.3%-93.2%). All-cause mortality at 30 days was 0%. All-cause mortality occurred in 6.6% at a median follow-up of 15 months. CONCLUSIONS:The Allegra TAVI system demonstrates promising technical and device success rates, with early safety and good post-implant haemodynamic performance in high-risk patients undergoing valve-in-valve TAVI. Larger randomized trials are needed to confirm these results.
Background Results from the Distal vs Conventional Radial Access (DISCO RADIAL) trial confirmed distal radial access (DRA) as a valid alternative to conventional transradial access, with equally low rates of radial artery occlusion (RAO), yet higher crossovers but shorter hemostasis. Objectives The purpose of the study was to investigate whether patient anthropometric measures influence the effect of randomized access on key secondary outcomes. Methods DISCO RADIAL was an international, multicenter, randomized controlled trial in which patients with indications for percutaneous coronary procedure using a 6-F Slender sheath were randomized to DRA (n = 650) or transradial access (n = 657) implementing best practices to reduce RAO. The primary endpoint of the trial was incidence of forearm RAO, which was extremely uncommon. Secondary endpoints, including sheath insertion time, radial artery spasm, crossover (failure to obtain access through assigned access site), hemostasis time, and access site complications, were the focus of the current analysis. Regression models (linear for continuous and logistic for binary outcomes) were used to determine whether anthropometric measures (weight, height, body mass index, and body surface area) influenced the effect of randomized access on outcomes. Results Across tertiles of weight, height, body mass index, and body surface area, both before and after adjustment for sex and age, the main effect of vascular access on radial artery spasm, crossover, hemostasis time, and access site complications remained, with no significant interaction effect. Conclusions The results of this exploratory analysis are consistent with the main findings of the trial and support the use of DRA in all patients, regardless of anthropometric measures.
BACKGROUND:Transcatheter aortic-valve implantation (TAVI) is associated with procedure-related stroke. Cerebral embolic protection (CEP) devices may reduce embolization to the cerebral circulation and hence the incidence of stroke. METHODS:We conducted a randomized, controlled trial across 33 centers in the United Kingdom. We randomly assigned 7635 participants with aortic stenosis in a 1:1 ratio to undergo TAVI with a CEP device (CEP group) or TAVI without a CEP device (control group). The primary outcome was stroke within 72 hours after TAVI or before discharge from the hospital (if discharge occurred sooner). RESULTS:A total of 3815 participants were assigned to the CEP group and 3820 to the control group. A primary-outcome event occurred in 81 of 3795 participants (2.1%) in the CEP group and in 82 of 3799 participants (2.2%) in the control group (difference, -0.02 percentage points; 95% confidence interval, -0.68 to 0.63; P = 0.94). Disabling stroke occurred in 47 participants (1.2%) in the CEP group and in 53 (1.4%) in the control group. Death occurred in 29 participants (0.8%) in the CEP group and in 26 (0.7%) in the control group. Overall access-site complications appeared to be similar in the two groups (8.1% in the CEP group and 7.7% in the control group). A total of 24 serious adverse events occurred in 22 of 3798 participants (0.6%) in the CEP group, and 13 serious adverse events occurred in 13 of 3803 participants (0.3%) in the control group. CONCLUSIONS:Among participants undergoing TAVI, routine use of CEP did not decrease the incidence of stroke within 72 hours. (Funded by the British Heart Foundation and Boston Scientific; BHF PROTECT-TAVI ISRCTN Registry number, ISRCTN16665769.).
BACKGROUND:The Synergy MegatronTM is an everolimus-drug eluting stent that may offer advantages in the treatment of aorto-ostial disease and large proximal vessels.AIMS:To report the short- to medium-term clinical outcomes from the European Synergy MegatronTM Implanters' Registry.METHODS:This registry was an investigator-initiated study conducted at 14 European centers. The primary outcome was target lesion failure (TLF), defined as the composite of cardiovascular death, target vessel myocardial infarction (MI), and target lesion revascularisation.RESULTS:Five hundred seventy-five patients underwent PCI with MegatronTM between 2019 and 2021. Patients were 69 ± 12 years old, 26% had diabetes mellitus, 24% had moderate-severe left ventricular impairment and 59% presented with an acute coronary syndrome. 15% were deemed prohibitively high risk for surgical revascularisation. The target vessel involved the left main stem in 55%, the ostium of the RCA in 13% and was a true bifurcation (Medina 1,1,1) in 50%. At 1 year, TLF was observed in 40 patients, with 26 (65%) occurring within the first 30 days. The cumulative incidence of TLF was 4.5% at 30 days and 8.6% (95% CI 6.3-11.7) at 1 year. The incidence of stent thrombosis was 0.5% with no late stent thromboses. By multivariate analysis, the strongest independent predictors of TLF were severe left ventricular impairment (HR 3.43, 95% CI: 1.67-6.76, p < 0.001) and a target vessel involving the left main (HR 4.00 95% CI 1.81-10.15 p = 0.001).CONCLUSIONS:Use of the Synergy MegatronTM everolimus eluting stent in a 'real-world' setting shows favorable outcomes at 30 days and 1 year.
Our study aimed to assess the characteristics and outcomes of transfemoral approach (TFA) versus the initial steps of a transradial approach (TRA) program and to assess the learning curve of TRA in contemporary, US practice.When compared to TFA, TRA has been shown to lower bleeding and vascular complications during percutaneous coronary intervention (PCI). However, use of TRA is still low. There are limited data regarding the characteristics of TRA learning curve, especially in an era with designated TRA equipment.Consecutive patients undergoing PCI in a single US center were divided into two cohorts according to vascular access approach: the last 250 TFA patients prior to the establishment of a TRA program and the initial 239 TRA patients following the establishment of a TRA program. Subgroup analysis of the TRA group, which was divided into five sequential case groups of 50 cases per group, was performed in order to assess TRA learning curve.Overall, the baseline characteristics of TFA vs. TRA groups were comparable. Fluoroscopy time was significantly longer during TRA procedures (18 ± 11 vs. 15 ± 8 min, respectively, p = 0.002); however, contrast use was lower during TRA procedures (161 ± 72 vs. 180 ± 63 ml, respectively, p = 0.002). In-hospital outcomes were similar between the two groups, with low frequencies of mortality, myocardial infarction, and stent thrombosis. Subanalysis of TRA group for learning curve assessment showed no major differences in patient demographics among the five subgroups. In the initial cases, more PCI was performed among non-acute cases (62% in patients 1–50 vs. 8–27% in patients 51–239, p < 0.001). Despite these differences, characteristics of the treated vessels were similar between groups. There was no significant change in fluoroscopy time or in the amount of iodinated contrast volume delivered. Similarly, no differences in procedural, in-hospital, and long-term outcomes were documented.Adopting TRA as a default is feasible for high-volume operators without significant learning curve effects.
BACKGROUND Currently, transradial access (TRA) is the recommended access for coronary procedures because of increased safety, with radial artery occlusion (RAO) being its most frequent complication, which will increasingly affect patients undergoing multiple procedures during their lifetimes. Recently, distal radial access (DRA) has emerged as a promising alternative access to minimize RAO risk. A large-scale, international, randomized trial comparing RAO with TRA and DRA is lacking. OBJECTIVES The aim of this study was to assess the superiority of DRA compared with conventional TRA with respect to forearm RAO. METHODS DISCO RADIAL (Distal vs Conventional Radial Access) was an international, multicenter, randomized controlled trial in which patients with indications for percutaneous coronary procedure using a 6-F Slender sheath were randomized to DRA or TRA with systematic implementation of best practices to reduce RAO. The primary endpoint was the incidence of forearm RAO assessed by vascular ultrasound at discharge. Secondary endpoints include crossover, hemostasis time, and access site-related complications. RESULTS Overall, 657 patients underwent TRA, and 650 patients underwent DRA. Forearm RAO did not differ between groups (0.91% vs 0.31%; P = 0.29). Patent hemostasis was achieved in 94.4% of TRA patients. Crossover rates were higher with DRA (3.5% vs 7.4%; P = 0.002), and median hemostasis time was shorter (180 vs 153 minutes; P < 0.001). Radial artery spasm occurred more with DRA (2.7% vs 5.4%; P = 0.015). Overall bleeding events and vascular complications did not differ between groups. CONCLUSIONS With the implementation of a rigorous hemostasis protocol, DRA and TRA have equally low RAO rates. DRA is associated with a higher crossover rate but a shorter hemostasis time. (C) 2022 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.
Abstract Background and Aims Coronary calcification remains a significant challenge for the contemporary interventional cardiologist. We aim to describe the use of intravascular lithotripsy (IVL) in a range of real‐world settings. Methods A retrospective two‐center analysis of patients treated with IVL between June 2018 and November 2019. Technical and procedural success, as well as procedural complications and 30‐day outcomes (death, myocardial infarction, or repeat target vessel revascularization), was recorded. Results Sixty‐five patients underwent IVL: 80% were male and the mean age was 70.1 ± 12.0 years. 54% of patients presented with acute coronary syndrome (ACS) and 68% of patients had intracoronary imaging. Twelve patients required IVL within pre‐existing stents, and 12 underwent IVL in the left main stem. All balloons were successfully delivered with 98.5% procedural success. There was a significant gain in MLA post PCI of 261.9 ± 100% following IVL. There were two procedural complications. At 30‐day follow‐up, there was one death, and one patient required a repeat procedure due to stent underexpansion. Conclusions In this largest real‐world series of imaging‐guided IVL for calcified lesions to date, we demonstrate that IVL is deliverable, safe, and effective at calcium modification especially when intracoronary imaging is used.
Background: Patients with complex high-risk coronary anatomy, such as those with a last remaining patent vessel (LRPV), are increasingly revascularized with percutaneous coronary intervention (PCI) in contemporary practice. There are limited data on the outcomes of these high-risk procedures. Methods: We analyzed a large longitudinal PCI cohort (2007–2014, n=501 841) from the British Cardiovascular Intervention Society database. Clinical, demographic, procedural, and outcome data were analyzed by dividing patients into 2 groups; LRPV group (n=2432) and all other PCI groups (n=506 691). Results: Patients in the LRPV PCI group were older, had more comorbidities, and higher prevalence of moderate-severe left ventricular systolic dysfunction. Mortality was higher in the LRPV PCI group during hospital admission (12 % versus 1.5 %, P <0.001), at 30 days (15% versus 2%, P <0.001), and at one-year (24% versus 5%, P <0.001). In a propensity score matching analysis the adjusted risk of mortality during index admission (odds ratio, 2.05 [95% CI, 1.65–2.44], P <0.001), at 30 days (odds ratio, 2.13 [95% CI, 1.78–2.5], P <0.001), at 1 year (odds ratio, 1.81 [95% CI, 1.59–2.03], P <0.001), and in-hospital major adverse cardiovascular events (odds ratio, 1.8 [95% CI, 1.42–2.19], P <0.001) were higher in LRPV PCI group as compared to control group. In sensitivity analyses, similar clinical outcomes were observed irrespective of which major epicardial coronary artery was treated. Conclusions: In this contemporary cohort, patients who had PCI to their LRPV had a higher-risk profile and more adverse clinical outcomes, irrespective of the vessel treated.
BACKGROUND:Whether cannabis use worsens outcomes in coronary heart disease is unknown and no previous study has evaluated the outcomes for patients who undergo percutaneous coronary intervention (PCI) according to cannabis use.METHODS:We analysed patients in the National Inpatient Sample between 2004 and 2014 who underwent PCI and evaluated rates, predictors and outcomes of patients according to cannabis misuse defined by cannabis abuse or dependence.RESULTS:A total of 7 306 012 patients were included and 32 765 cannabis misusers (0.4%). Cannabis misusers were younger (49.5 vs 64.6 years, P < .001) and were more likely to be male (82.7% vs 66.3%, P < .001). There was also a greater proportion of patients who were of black ethnicity in the cannabis misuse group (27.7% vs 7.9%, P < .001) and fewer elective admissions (7.8% vs 27.6%, P < .001). There was no difference in in-hospital mortality (OR 1.06 95% CI 0.80-1.40, P = .67), bleeding (OR 0.94 95% CI 0.77-1.15, P = .55) and stroke/transient ischaemic attack (OR 1.19 95% CI 0.98-1.45, P = .084) compared with non-cannabis misusers. Cannabis misusers had significantly lower odds of in-hospital vascular complications (OR 0.73 95% CI 0.58-0.90, P = .004).CONCLUSIONS:Our results suggest that cannabis misusers are more likely to be male, of black ethnicity and from the lowest quartile of income, but there was no evidence that cannabis misuse is associated with worse periprocedural outcomes following PCI when controlling for key proxies of health status.
A 62-year-old female was admitted with severe left-sided chest pain, nausea and pre-syncope. She had widespread T wave inversion on ECG and elevated troponins and was suspected to have an acute coronary syndrome event. Invasive coronary angiogram revealed normal coronary anatomy with no flow-limiting lesions. Echocardiography and cardiac MRI revealed impaired left ventricular (LV) systolic impairment, a mobile LV apical thrombus and a moderate global pericardial effusion with no significant compromise. Full blood count analysis indicated the patient to have significant eosinophilia, and the patient was diagnosed with idiopathic eosinophilic myocarditis. She was commenced on Prednisolone and Apixaban, and eosinophil levels returned to normal after 10 days of steroids. Over the course of 3 months, the patient had a complete recovery of her LV function and resolution of the LV thrombus. This case highlights a rare, reversible case of idiopathic eosinophilic myocarditis which may present similar to acute coronary syndrome.
Objectives This study aimed to examine the cost of coronary syndrome treated with percutaneous coronary intervention (PCI) and 30-day unplanned readmissions. Background There is limited understanding of the hospital cost of index PCI and 30-day unplanned readmissions. Methods Patients undergoing PCI between 2010 and 2014 in the U.S. Nationwide Readmission Database were included. The primary outcome was total cost defined by cost of index PCI and first unplanned readmission within 30 days. Results This analysis included 2,294,244 patients who underwent PCI, and the mean cost was $23,541 +/- $20,730 (similar to$10.8 billion/year). There was a modest increase in cost over the study years of 17.5%. Of the 9.4% with an unplanned readmission within 30 days, the mean total cost was $35,333 +/- 24,230 versus $22,323 +/- 19,941 for those not readmitted. The variables most strongly associated with the highest quartile of cost were heart failure (adjusted odds ratio (aOR) 25.60 [95% CI 21.59-30.35]), need for circulatory support (aOR 11.62 [10.13-13.32]), periprocedural coronary artery bypass graft (CABG, aOR 585.08 [357.85-956.58]), and readmission within 30 days (aOR 24.49 [22.40-26.77]). An acute kidney injury (AKI; 8.5%), major bleed (0.8%), vascular injury (0.8%), or need for periprodedural CABG (1.4%) had an average increased cost of $21,935; $30,898; $27,875; and $43,005, respectively, compared to PCI without adverse outcome. Conclusions The annual 30-day hospital cost of PCI is approximately $10.8 billion, and the costs associated with in-hospital adverse events, particularly the need for AKI and periprocedural CABG, were significant.
Percutaneous coronary intervention (PCI) in the context of heavily calcified coronary arteries can be challenging. Intravascular lithotripsy (IVL) has been suggested as an alternative to rotational atherectomy (RA). We report a case of stent under expansion, despite plaque modification using rotational atherectomy that was successfully managed with intravascular lithotripsy.
Annular Rupture Successfully Salvaged by Valve-in-Valve Implantation