CT or Invasive Coronary Angiography in Stable Chest Pain.

BACKGROUND: In the diagnosis of obstructive coronary artery disease (CAD), computed tomography (CT) is an accurate, noninvasive alternative to invasive coronary angiography (ICA). However, the comparative effectiveness of CT and ICA in the management of CAD to reduce the frequency of major adverse cardiovascular events is uncertain. METHODS: We conducted a pragmatic, randomized trial comparing CT with ICA as initial diagnostic imaging strategies for guiding the treatment of patients with stable chest pain who had an intermediate pretest probability of obstructive CAD and were referred for ICA at one of 26 European centers. The primary outcome was major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) over 3.5 years. Key secondary outcomes were procedure-related complications and angina pectoris. RESULTS: Among 3561 patients (56.2% of whom were women), follow-up was complete for 3523 (98.9%). Major adverse cardiovascular events occurred in 38 of 1808 patients (2.1%) in the CT group and in 52 of 1753 (3.0%) in the ICA group (hazard ratio, 0.70; 95% confidence interval [CI], 0.46 to 1.07; P = 0.10). Major procedure-related complications occurred in 9 patients (0.5%) in the CT group and in 33 (1.9%) in the ICA group (hazard ratio, 0.26; 95% CI, 0.13 to 0.55). Angina during the final 4 weeks of follow-up was reported in 8.8% of the patients in the CT group and in 7.5% of those in the ICA group (odds ratio, 1.17; 95% CI, 0.92 to 1.48). CONCLUSIONS: Among patients referred for ICA because of stable chest pain and intermediate pretest probability of CAD, the risk of major adverse cardiovascular events was similar in the CT group and the ICA group. The frequency of major procedure-related complications was lower with an initial CT strategy. (Funded by the European Union Seventh Framework Program and others; DISCHARGE ClinicalTrials.gov number, NCT02400229.).

Single-center prospective study examining use of the Wattson temporary pacing guidewire for transcatheter aortic valve replacement.

OBJECTIVES: To assess the safety and efficacy of the Wattson temporary pacing guidewire. BACKGROUND: Transcatheter aortic valve replacement (TAVR) requires a guidewire for device delivery and generally requires temporary pacing wire for burst and back-up pacing. The Wattson wire provides concomitant support and bipolar pacing without the need to place a temporary venous pacemaker (TVP). METHODS: This was a single-center nonrandomized prospective clinical trial enrolling 20 patients. The primary endpoint was defined as successful rapid pacing and transcatheter heart valve (THV) delivery with no loss of capture. Safety, qualitative and quantitative secondary outcomes were also analyzed. RESULTS: Mean age was 77.4 ± 9.0 years. Mean Society of Thoracic Surgery (STS) score was 3.0 ± 1.5%. All patients received a balloon-expandable valve via a transfemoral approach. All patients met the primary end-point. One patient (5%) had balloon predilatation and six patients (30%) had postdilatation, all using the wire. Mean pacing threshold was 2.2 ± 1.2 mA that was evaluated prior to placing an insulating catheter over the wire. One patient required TVP placement and subsequent permanent pacemaker implantation due to complete heart block post THV deployment. There were no incidences of cardiac perforation or tamponade. One patient required valve reintervention, which was not related to the device. CONCLUSIONS: The Wattson wire offered predictable guidewire support with concomitant reliable bipolar pacing at low thresholds to allow safe THV delivery in this patient cohort. It has the potential to make TAVR a safer and more efficient procedure.

Performance of the TRUE dilatation balloon valvuloplasty catheter beyond rated burst pressure: A bench study.

OBJECTIVES: We undertook an independent bench test assessing the performance of the TRUE dilatation (TD) balloon valvuloplasty catheter (Bard Vascular Inc., Tempe, AZ) beyond its rated burst pressure (RBP). BACKGROUND: The TD balloon has a RBP of six atmospheres (atm), and its performance beyond this RBP is poorly understood. Techniques such as bioprosthetic valve fracture require inflation pressures beyond manufacturer recommendations. METHODS: A 20, 22, 24, 26, and 28 mm TD balloon were inflated to increasing pressures in increments of 3 atm until balloon failure. Measurements were performed at the proximal, middle, and distal balloon segments with scientific digital calipers. Z-MED balloons (Braun Interventional Systems Inc., Bethlehem, PA) were used as a comparator. RESULTS: The mean diameter at the middle of the 20, 22, 24, 26, and 28 mm TD balloon at nominal pressure (3 atm) was 20.02 ± 0.09, 21.77 ± 0.07, 23.9 ± 0.06, 25.82 ± 0.08, and 27.62 ± 0.08 mm, respectively. The maximal mean diameter at the middle of the 20, 22, 24, 26, and 28 mm TD balloon was 20.39 ± 0.03 mm (15 atm), 22.35 ± 0.03 mm (15 atm), 24.55 ± 0.02 mm (15 atm), 26.48 ± 0.02 mm (12 atm), and 28.39 ± 0.03 mm (12 atm), respectively. The 20/22/24 and 26/28 mm balloon failed when inflated beyond 15 atm and 12 atm, respectively. Failure was due to either leakage or longitudinal balloon rupture. TD balloons were more likely to maintain dimensions similar to their labeled size and less likely to fail at higher pressures as compared to Z-MED balloons. CONCLUSION: The TD balloon catheter maintains a similar diameter to its labeled size, when inflated beyond its RBP. When inflated beyond 12 atm, the TD balloon can fail due to either leakage or rupture. This has implications for percutaneous structural heart interventions.

Implications of hydrodynamic testing to guide sizing of self-expanding transcatheter heart valves for valve-in-valve procedures.

AIMS: The commonly used valve-in-valve (VIV) app recommends sizing based on dimensions of both the transcatheter heart valve (THV) and bioprosthetic surgical valve. The implications of hydrodynamic testing to guide VIV sizing are poorly understood. This bench study assessed the hydrodynamic performance of different sizes of self-expanding supra-annular THVs in three different surgical aortic bioprostheses at different implantation depths. METHODS: A small versus medium ACURATE neo (ACn), and a 26 mm versus 29 mm Evolut R were assessed after VIV implantation in 25 mm Mitroflow, Mosaic, and Magna Ease aortic surgical bioprostheses, at three implantation depths (+2 mm, -2 mm, and -6 mm). RESULTS: The medium-sized ACn had lower gradients compared to the small ACn when the THV was implanted high (+2 mm, or -2 mm). The 29 mm Evolut R had lower gradients compared to a 26 mm Evolut R for all implantation depths, except for a depth of -2 mm in the 25 mm Mitroflow. The medium ACn and 29 mm Evolut R had larger effective orifice areas compared to the small ACn and 26 mm Evolut R, respectively. Both Evolut R sizes had acceptable regurgitant fractions (<15%), while both ACn sizes were above the acceptable performance criteria (>15%), at all implantation depths. CONCLUSIONS: Use of a larger self-expanding THV was associated with superior hydrodynamic performance if the THV was implanted high. Hydrodynamic testing can provide additional information to the VIV app to help guide VIV sizing.

Mitral regurgitation in patients undergoing transcatheter aortic valve implantation for degenerated surgical aortic bioprosthesis: Insights from PARTNER 2 Valve-in-Valve Registry.

BACKGROUND: Valve-in-valve (VIV) treatment with transcatheter aortic valve replacement (TAVR) is a viable option for patients with failing aortic bioprosthetic valves. Optimal management of those with concomitant mitral regurgitation (MR) remains undetermined. Therefore, we sought to assess the implications of concomitant MR in patients undergoing VIV-TAVR. METHODS AND RESULTS: The PARTNER 2 VIV registry enrolled patients with degenerated surgical aortic bioprosthesis at high risk for reoperation. Patients with core-laboratory echocardiographic assessment of MR were analyzed; severe MR was excluded. We compared patients with ≤mild MR versus moderate MR and assessed changes in MR severity and clinical outcomes. A total of 339 patients (89 initial registry, 250 continued access) underwent VIV procedures; mean age 79.0 ± 10.2 years, mean Society of Thoracic Surgeon score 8.9 ± 4.5%. At baseline, 228/339 (67.3%) had ≤mild MR and 111/339 (32.7%) had moderate MR. In paired analysis, there was significant improvement in ≥moderate MR from baseline to 30 days (32.6% vs. 14.5%, p < .0001 [n = 304]), and no significant change between 30 days and 1 year (13.4% vs. 12.1%, p = .56 [n = 224]) or 1 year and 2 years (11.0% vs. 10.4%, p = .81 [n = 182]). There was no difference in death or stroke between ≤mild MR and moderate MR at 30 days (4.0% vs. 7.2%, p = .20), 1 year (15.5% vs. 15.3%, p = .98) or 2 years (26.5% vs. 23.5%, p = .67). CONCLUSION: Moderate concomitant MR tends to improve with VIV-TAVR, and was not a predictor of long-term adverse outcomes in this cohort. In selected patients undergoing VIV-TAVR, it may be appropriate to conservatively manage concomitant MR. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT# 03225001.

Correction to: Pilot study of the multicentre DISCHARGE trial: image quality and protocol adherence results of computed tomography and invasive coronary angiography.

The original version of this article, published on 16 December 2019, unfortunately contained two mistakes.

Pilot study of the multicentre DISCHARGE Trial: image quality and protocol adherence results of computed tomography and invasive coronary angiography.

OBJECTIVE: To implement detailed EU cardiac computed tomography angiography (CCTA) quality criteria in the multicentre DISCHARGE trial (FP72007-2013, EC-GA 603266), we reviewed image quality and adherence to CCTA protocol and to the recommendations of invasive coronary angiography (ICA) in a pilot study. MATERIALS AND METHODS: From every clinical centre, imaging datasets of three patients per arm were assessed for adherence to the inclusion/exclusion criteria of the pilot study, predefined standards for the CCTA protocol and ICA recommendations, image quality and non-diagnostic (NDX) rate. These parameters were compared via multinomial regression and ANOVA. If a site did not reach the minimum quality level, additional datasets had to be sent before entering into the final accepted database (FADB). RESULTS: We analysed 226 cases (150 CCTA/76 ICA). The inclusion/exclusion criteria were not met by 6 of the 226 (2.7%) datasets. The predefined standard was not met by 13 of 76 ICA datasets (17.1%). This percentage decreased between the initial CCTA database and the FADB (multinomial regression, 53 of 70 vs 17 of 75 [76%] vs [23%]). The signal-to-noise ratio and contrast-to-noise ratio of the FADB did not improve significantly (ANOVA, p = 0.20; p = 0.09). The CTA NDX rate was reduced, but not significantly (initial CCTA database 15 of 70 [21.4%]) and FADB 9 of 75 [12%]; p = 0.13). CONCLUSION: We were able to increase conformity to the inclusion/exclusion criteria and CCTA protocol, improve image quality and decrease the CCTA NDX rate by implementing EU CCTA quality criteria and ICA recommendations. KEY POINTS: • Failure to meet protocol adherence in cardiac CTA was high in the pilot study (77.6%). • Image quality varies between sites and can be improved by feedback given by the core lab. • Conformance with new EU cardiac CT quality criteria might render cardiac CTA findings more consistent and comparable.

Health-related qualify of life, angina type and coronary artery disease in patients with stable chest pain.

BACKGROUND: Health-related quality of life (HRQoL) is impaired in patients with stable angina but patients often present with other forms of chest pain. The aim of this study was to compare the pre-diagnostic HRQoL in patients with suspected coronary artery disease (CAD) according to angina type, gender, and presence of obstructive CAD. METHODS: From the pilot study for the European DISCHARGE trial, we analysed data from 24 sites including 1263 patients (45.9% women, 61.1 ± 11.3 years) who were clinically referred for invasive coronary angiography (ICA; 617 patients) or coronary computed tomography angiography (CTA; 646 patients). Prior to the procedures, patients completed HRQoL questionnaires: the Short Form (SF)-12v2, the EuroQoL (EQ-5D-3 L) and the Hospital Anxiety and Depression Scale. RESULTS: Fifty-five percent of ICA and 35% of CTA patients had typical angina, 23 and 33% had atypical angina, 18 and 28% had non-anginal chest discomfort and 5 and 5% had other chest discomfort, respectively. Patients with typical angina had the poorest physical functioning compared to the other angina groups (SF-12 physical component score; 41.2 ± 8.8, 43.3 ± 9.1, 46.2 ± 9.0, 46.4 ± 11.4, respectively, all age and gender-adjusted p < 0.01), and highest anxiety levels (8.3 ± 4.1, 7.5 ± 4.1, 6.5 ± 4.0, 4.7 ± 4.5, respectively, all adjusted p < 0.01). On all other measures, patients with typical or atypical angina had lower HRQoL compared to the two other groups (all adjusted p < 0.05). HRQoL did not differ between patients with and without obstructive CAD while women had worse HRQoL compared with men, irrespective of age and angina type. CONCLUSIONS: Prior to a diagnostic procedure for stable chest pain, HRQoL is associated with chest pain characteristics, but not with obstructive CAD, and is significantly lower in women. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02400229.

Correction to: Health-related qualify of life, angina type and coronary artery disease in patients with stable chest pain.

An amendment to this paper has been published and can be accessed via the original article.

Overexpansion of older generation balloon expandable transcatheter heart valves: An ex-vivo bench study.

BACKGROUND: The SAPIEN 3 (S3) transcatheter heart valve (THV) can be over-expanded beyond its labeled diameter. Overexpansion can be achieved with use of either a compliant or non-compliant balloon. Objective data regarding the ability to over-expand older generation balloon expandable valves are limited. We sought to assess the effects of over-expanding the SAPIEN and SAPIEN XT (Edwards Lifesciences, Irvine, CA) valve beyond labeled size (diameter) through an ex-vivo bench study. METHODS AND RESULTS: We assessed SAPIEN and SAPIEN XT THVs, sized 23/26 mm and 23/26/29 mm, respectively. The SAPIEN THVs were explanted samples. Valves were expanded to nominal dimensions, and then incrementally overexpanded with balloons sized 1-, 2-, and 3-mm larger than the recommended diameter. When an appropriate sized non-compliant balloon was not available, a compliant balloon was utilized. Valves underwent visual and radiographic assessment of overexpansion. SAPIEN THVs with labeled size of 23 and 26 mm could be incrementally overexpanded to midvalve (MV) diameters of 26.7 and 27.4 mm, respectively. SAPIENT XT THVs with labeled size of 23, 26, and 29 mm could be incrementally overexpanded to MV diameters of 26.8, 28.3, and 28.8 mm, respectively. The desired degree of overexpansion was only achieved with use of non-compliant balloons and not with compliant balloons. The outflow of the SAPIEN and SAPIEN XT had larger diameters than the MV and inflow of the THV. CONCLUSION: Overexpansion of older generation SAPIEN and SAPIEN XT THVs is possible. Achieving the desired degree of overexpansion was only achieved with use of non-compliant balloons. This has potential implications for the treatment of failed THVs.

TAVR and SAVR in ESRD: Just because we can doesn't necessarily mean that we should.

In patients with end stage renal disease on hemodialysis, TAVR resulted in reduced length of stay, hospitalization cost, complication rate and higher rates of home discharge compared to SAVR. In-hospital mortality and complication rates were high in both groups. Careful patient selection and further research is required to identify patients with end-stage renal disease who might, or might not, benefit from intervention.

Accuracy in precordial ECG lead placement: Improving performance through a peer-led educational intervention.

BACKGROUND AND OBJECTIVES: Inaccurate electrocardiography (ECG) lead placement may lead to erroneous diagnoses, such as poor R wave progression. We sought to assess the accuracy of precordial ECG lead placement amongst hospital staff members, and to re-evaluate performance after an educational intervention. METHODS AND RESULTS: 100 randomly selected eligible staff members placed sticker dots on a mannequin, their positions were recorded on a radar plot and compared to the correct precordial lead positions. The commonest errors were placing V1 and V2 leads too superiorly, and V5 and V6 leads too medially.Following an educational intervention with the aid of moderated poster presentations and volunteer patients, the study was repeated six months later. 60 subjects correctly placed all leads, compared to 10 in the pre-intervention cohort (P<0.0001) with the proportion achieving correct placement of any lead rising from 0.34 to 0.83, (p<0.0001 for all leads). CONCLUSION: Incorrect ECG lead placement is common. This may be addressed through regular training incorporated into annual induction processes for relevant health care professionals.

The use of a novel ROX central arteriovenous fistula formation device in a patient with severe drug-resistant hypertension and prior aortic graft.

We report a case of the successful use of a central arteriovenous (cAV) coupler device to treat severe drug-resistant primary hypertension in a 46-year-old female. The device is inserted via a femoral approach to create an ateriovenous fistula between the external iliac artery and vein and has shown promise in the treatment of severe hypertension. The patient's 24-hr ambulatory blood pressure (ABP) pre device insertion on eleven anti-hypertensive medications revealed a mean 24-hr ABP of 165/98 mm Hg. The insertion of the cAV coupler resulted in a sustained anti-hypertensive effect nine months post-procedure, with mean 24-hr ABP of 154/91 mm Hg on only two anti-hypertensives. Her significant anti-hypertensive response may be explained by the presence of an inelastic aortic graft that had been inserted due to prior aortic dissection as it allowed the restoration of elasticity in a previously inelastic arterial system. We believe that the ROX cAV coupler device warrants further investigation. © 2017 Wiley Periodicals, Inc.

Is Heart Rate a Norepiphenomenon in Heart Failure?

There has been an increased focus on heart rate as a target in the management of cardiovascular disease and more specifically in heart failure with preserved ejection fraction in recent years with several studies showing the benefit of a lower resting heart rate on outcomes. This review paper examines the pathophysiology behind the benefits of lowering heart rate in heart failure and also the evidence for and against the pharmacological agents available to achieve this.

Age and Computed Tomography and Invasive Coronary Angiography in Stable Chest Pain: A Prespecified Secondary Analysis of the DISCHARGE Randomized Clinical Trial.

Importance: The effectiveness and safety of computed tomography (CT) and invasive coronary angiography (ICA) in different age groups is unknown. Objective: To determine the association of age with outcomes of CT and ICA in patients with stable chest pain. Design, Setting, and Participants: The assessor-blinded Diagnostic Imaging Strategies for Patients With Stable Chest Pain and Intermediate Risk of Coronary Artery Disease (DISCHARGE) randomized clinical trial was conducted between October 2015 and April 2019 in 26 European centers. Patients referred for ICA with stable chest pain and an intermediate probability of obstructive coronary artery disease were analyzed in an intention-to-treat analysis. Data were analyzed from July 2022 to January 2023. Interventions: Patients were randomly assigned to a CT-first strategy or a direct-to-ICA strategy. Main Outcomes and Measures: MACE (ie, cardiovascular death, nonfatal myocardial infarction, or stroke) and major procedure-related complications. The primary prespecified outcome of this secondary analysis of age was major adverse cardiovascular events (MACE) at a median follow-up of 3.5 years. Results: Among 3561 patients (mean [SD] age, 60.1 [10.1] years; 2002 female [56.2%]), 2360 (66.3%) were younger than 65 years, 982 (27.6%) were between ages 65 to 75 years, and 219 (6.1%) were older than 75 years. The primary outcome was MACE at a median (IQR) follow-up of 3.5 (2.9-4.2) years for 3523 patients (99%). Modeling age as a continuous variable, age, and randomization group were not associated with MACE (hazard ratio, 1.02; 95% CI, 0.98-1.07; P for interaction = .31). Age and randomization group were associated with major procedure-related complications (odds ratio, 1.15; 95% CI, 1.05-1.27; P for interaction = .005), which were lower in younger patients. Conclusions and Relevance: Age did not modify the effect of randomization group on the primary outcome of MACE but did modify the effect on major procedure-related complications. Results suggest that CT was associated with a lower risk of major procedure-related complications in younger patients. Trial Registration: ClinicalTrials.gov Identifier: NCT02400229.

Safety and efficacy of e-cigarettes in those with atherosclerotic disease: a review.

Smoking cessation is the most effective intervention to reduce mortality in patients with established atherosclerotic cardiovascular disease (ASCVD), with 'e-cigarettes' becoming an increasingly used intervention to achieve smoking cessation. The current review aims to summarise the current evidence base for their efficacy and safety in the ASCVD cohort. A search of the PUBMED and MEDLINE databases using the terms 'e-cigarette', 'cessation', 'safety' and 'efficacy' since 2012 yielded 706 results. Both observational and experimental studies were included, while those with an unavailable full text, non-English or duplicates were excluded, yielding 78 relevant articles, with 13 subsequent additional articles included from a search of reference lists, for a total of 91 included papers. E-cigarette vapour contains many known pro-atherosclerotic substances and has been demonstrated to potentiate traditional atherosclerotic mechanisms. While e-cigarettes may be more effective in promoting smoking cessation in the general population over a medium term (>6 months), when compared with nicotine replacement therapy (NRT), few studies specifically examined those with ASCVD, despite the latter having a higher baseline quit rate (52% vs 2%). Most studies compare e-cigarettes with NRT alone and do not include pharmacotherapy, which may be more effective in the ASCVD cohort. The single randomised controlled trial addressing the research question favoured traditional methods. Those that successfully quit smoking using e-cigarettes are more likely to continue to use the intervention at 1 year (90% vs 9%). Conflicting advice exists regarding the utilisation of e-cigarettes for smoking cessation. E-cigarettes may be inferior to standard care for smoking cessation in those with ASCVD, and their use is likely to promote the key drivers of the atherosclerotic process already active in this cohort.

The use of deformation imaging in the assessment of patients pre and post transcatheter aortic valve implantation.

BACKGROUND: Deformation imaging represents a method of measuring myocardial function, including global longitudinal strain (GLS), peak atrial longitudinal strain (PALS) and radial strain. This study aimed to assess subclinical improvements in left ventricular function in patients undergoing transcatheter aortic valve implantation (TAVI) by comparing GLS, PALS and radial strain pre and post procedure. METHODS: We conducted a single site prospective observational study of 25 patients undergoing TAVI, comparing baseline and post-TAVI echocardiograms. Individual participants were assessed for differences in GLS, PALS and radial strain in addition to changes in left ventricular ejection fraction (LVEF) (%). RESULTS: Our results revealed a significant improvement in GLS (mean change pre-post of 2.14% [95% CI 1.08, 3.20] p = 0.0003) with no significant change in LVEF (0.96% [95% CI - 2.30, 4.22], p = 0.55). There was a statistically significant improvement in radial strain pre and post TAVI (mean 9.68% [95% CI 3.10, 16.25] p = 0.0058). There was positive trend towards improvements in PALS pre and post TAVI (mean change of 2.30% [95% CI - 0.19, 4.80] p = 0.068). CONCLUSION: In patients undergoing TAVI, measuring GLS and radial strain provided statistically significant information regarding subclinical improvements in LV function, which may have prognostic implications. The incorporation of deformation imaging in addition to standard echocardiographic measurements may have an important role in guiding future management in patients undergoing TAVI and assessing response.

Intravascular lithotripsy-assisted PCI for severely calcified coronary lesions: evaluating the impact on quality of life and outcomes.

BACKGROUND: Despite the increased uptake of intravascular lithotripsy (IVL) for treating severely calcified coronary lesions, there is limited patient-level data examining the effect of IVL on quality of life, symptomatology, and outcomes beyond 30 days. We sought to assess demographics, procedural characteristics, outcomes, and impact of IVL on patient-reported angina after a minimum of 6 months follow-up. METHODS: A retrospective single-center study was conducted of patients treated with coronary IVL between January and October 2020. Baseline demographics were obtained from electronic patient records and SYNTAX scores were calculated from index coronary angiograms. Technical success and complications were assessed along with clinical outcomes, which included all-cause mortality, myocardial infarction (MI), target lesion revascularization (TLR), and MACE (composite of death, stroke, MI, and TLR). Canadian Cardiovascular Society (CCS) angina classification was assessed at virtual clinical follow-up. RESULTS: Forty-seven consecutive patients were included. At a mean follow-up of 306 ± 74 days, the mean CCS angina score was reduced by 53% post-IVL-assisted PCI (2.9 vs 1.4, p < 0.001). Technical and procedural success were high (94% and 92%, respectively). One patient (2%) met the pre-specified criteria for in-hospital MACE and 4 (9%) met pre-specified MACE at follow-up, including 2 deaths and 2 TLR. Procedural complications included coronary dissection (11%) and coronary perforation (6%) and were managed either conservatively or with PCI. CONCLUSIONS: Coronary IVL is a safe and effective adjunctive therapy for treating heavily calcified coronary lesions. This cohort shows high procedural success and a significant reduction in CCS angina at follow-up.