Treatment of Calcified Lesions Using a Dedicated Super-High Pressure Balloon: Multicenter Optical Coherence Tomography Registry.

BACKGROUND: Calcified lesions often lead to difficulty achieving optimal stent expansion. OPN non-compliant (NC) is a twin layer balloon with high rated burst pressure that may modify calcium effectively. METHODS: Retrospective, multicenter registry in patients undergoing optical coherence tomography (OCT) guided intervention with OPN NC. Superficial calcification with > 180o arc and > 0.5 mm thickness, and/or nodular calcification with > 90o arc were included. OCT was performed in all cases before and after OPN NC, and after intervention. Primary efficacy endpoints were frequency of expansion (EXP) ≥80 % of the mean reference lumen area and mean final EXP by OCT, and secondary endpoints were calcium fractures (CF), and EXP ≥90 %. RESULTS: 50 cases were included; 25 (50 %) superficial, and 25 (50 %) nodular. Calcium score of 4 in 42 (84 %) cases and 3 in 8 (16 %). OPN NC was used alone, or after other devices if further modification was needed, NC in 27 (54 %), cutting in 29 (58 %), scoring in 1 (2 %), IVL in 2 (4 %); or if non-crossable lesion, rotablation in 5 (10 %) cases. EXP ≥80 % was achieved in 40 (80 %) cases with mean final EXP post intervention of 85.7 % ± 8.9. CF were documented in 49 (98 %) cases; multiple in 37 (74 %). There were 1 flow limiting dissection requiring stent deployment and 3 non-cardiovascular related deaths in 6 months follow-up. No records of perforation, no-reflow or other major adverse events. CONCLUSION: Among patients with heavy calcified lesions undergoing OCT guided intervention with OPN NC, acceptable expansion was achieved in most cases without procedure related complications.

A mouth watering case of Mycoplasma salivarium native mitral valve endocarditis: 'case report'.

BACKGROUND: Mycoplasma salivarium is part of our commensal oral flora and readily resides in dental plaque. Although considered indolent, few case reports have documented its pathogenic potential in humans. To this day no case of Mycoplasma salivarium infectious endocarditis has ever been described. CASE PRESENTATION: Our report describes a challenging case of Mycoplasma salivarium endocarditis, with a patient presenting with oligoarticular joint swelling, and later on in the course of his disease developed signs of right-sided heart failure. The diagnosis was initially mistaken for septic gonarthritis and was later established on the basis of echocardiography and eubacterial PCR of joint fluid. CONCLUSION: This report describes a first documented case of Mycoplasma salivarium culture negative endocarditis that was successfully treated with targeted antimicrobial therapy. Specific antimicrobial therapy targeting Mycoplasma spp, lead to clinical improvement, with radiological regression of the lesion and the resolution of the serum inflammation biomarkers.

"Burying" covered coronary stents under drug-eluting stents: A novel approach to ensure long-term stent patency.

BACKGROUND: Covered coronary stent (CS) implantation is associated with a high risk for in-stent restenosis (ISR) and stent thrombosis (ST). We describe the outcomes after overstenting ("burying") CS using contemporary drug-eluting stents (DES). METHODS: We analyzed short- and long-term outcomes of consecutive patients who had had a CS implanted, which was consecutively covered ("buried") with a third-generation DES. CSs were primarily post-dilated and then covered with a longer DES overlapping the proximal and distal edges of the CS. To ensure optimal stent expansion and appositions, all lesions were post-dilated using adequately sized non-compliant balloons. RESULTS: Between 2015 and 2020, 23 patients (mean age 67 ± 14 years, 74% males) were treated using this novel approach. Reasons for implanting CS included treatment of coronary aneurysms (n = 7; 30%), coronary perforations (n = 13; 57%), and aorto-ostial dissections (n = 3; 13%). All CSs were successfully deployed, and no peri-procedural complications occurred. The median time of follow-up was 24.5 (interquartile range [IQR] 11.7-37.9) months. All patients had a 1-month follow-up (FU) and 19/23 (83%) patients had 12-month FU (FU range 1-60 months). No probable or definite STs occurred, and no cardiovascular deaths were observed. Among patients undergoing angiographic FU (11/23 [48%]), 1/23 showed angiographically significant ISR 6 months post CS implantation. CONCLUSIONS: Burying a coronary CS under a DES appears to be a safe and promising strategy to overcome the limitations of the currently available CS devices, including a relatively high risk for target lesion failure due to ISR and ST.

Efficacy of Ranolazine for Treatment of Coronary Microvascular Dysfunction-A Systematic Review and Meta-analysis of Randomized Trials.

BACKGROUND: Coronary microvascular dysfunction (CMD) is a common cause of angina and exercise intolerance in patients without obstructive coronary artery disease. The efficacy of ranolazine, a late sodium channel blocker, in patients with symptomatic obstructive coronary artery disease is well established. To evaluate the efficacy of ranolazine in CMD, we performed a systematic review and meta-analysis of randomized studies. METHODS: MEDLINE, EMBASE, Cochrane CENTRAL, and conference abstracts were searched from January 1975 to March 2020. Randomized trials evaluating ranolazine in patients with CMD were screened. Two reviewers independently extracted data and assessed study quality. End points of interest included a change in angina measured by the Seattle Angina Questionnaire (SAQ), coronary flow reserve (CFR), and clinical outcomes. Data were combined using random-effects models. RESULTS: Of 836 citations, 6 randomized studies (318 patients) were included. Median follow-up was 4 weeks. When pooling the 6 trials analyzing ranolazine, we found that patients treated with ranolazine had a higher SAQ value regarding physical functioning (mean difference, 6.42; 95% confidence interval [CI], 2.41; 10.42) quality of life (10.07; 95% CI, 3.4; 16.74), and angina stability (20.14; 95% CI, 10.12; 30.17), as well as improved CFR (0.27; 95% CI, 0.09; 0.45) compared with placebo/control therapy. A high heterogeneity was observed (range I 2, 30%-84%). CONCLUSIONS: In CMD, ranolazine may be associated with improvements in CFR and some of the SAQ domains, including angina stability, physical functioning, and quality of life. However, it does not seem to beneficially impact angina frequency and treatment satisfaction. It is also unknown if it improves prognosis of afflicted patients.

CONTEXTE: La dysfonction microvasculaire coronaire (DMC) est une cause courante d'angine et d'intolérance à l'effort chez les patients sans coronaropathie obstructive. L'efficacité de la ranolazine, un bloqueur des canaux sodiques tardifs, chez les patients atteints d'une coronaropathie obstructive symptomatique est bien établie. Pour évaluer l'efficacité de la ranolazine dans le traitement de la DMC, nous avons effectué une revue systématique et méta-analyse d'études à répartition aléatoire. MÉTHODOLOGIE: MEDLINE, EMBASE, Cochrane CENTRAL et les résumés de congrès ont fait l'objet d'une recherche pour la période allant de janvier 1975 à mars 2020. Les essais à répartition aléatoire sur l'emploi de la ranolazine chez des patients atteints de DMC ont été criblés. Deux examinateurs ont, de manière indépendante, extrait les données et évalué la qualité des études. Les paramètres d'intérêt étaient une variation de l'angine mesurée à l'aide du questionnaire SAQ (Seattle Angina Questionnaire), la réserve coronaire et les issues cliniques. Les données ont été combinées avec des modèles à effets aléatoires. RÉSULTATS: Parmi 836 références, six études à répartition aléatoire (318 patients) ont été retenues. La durée médiane de suivi était de quatre semaines. Après avoir regroupé les données des six essais sur la ranolazine, nous avons constaté que les patients traités par la ranolazine avaient un score SAQ plus élevé en ce qui a trait au fonctionnement physique (différence moyenne : 6,42; intervalle de confiance [IC] à 95 % : 2,41 à 10,42), à la qualité de vie (10,07; IC à 95 % : 3,4 à 16,74) et à la stabilité de l'angine (20,14; IC à 95 % : 10,12 à 30,17), de même qu'une réserve coronaire améliorée (0,27; IC à 95 % : 0,09 à 0,45) comparativement aux patients ayant reçu un placebo/traitement témoin. Une forte hétérogénéité a été observée (plage des I 2 : 30 à 84 %). CONCLUSIONS: Dans les cas de DMC, la ranolazine est associée à des améliorations de la réserve coronaire et de certains des domaines du questionnaire SAQ, dont la stabilité de l'angine, le fonctionnement physique et la qualité de vie. Toutefois, elle ne semble pas avoir d'effet bénéfique sur la fréquence de l'angine et la satisfaction à l'égard du traitement. On ne sait pas non plus si elle améliore le pronostic des patients touchés.

Long-Term Outcomes of the FORMA Transcatheter Tricuspid Valve Repair System for the Treatment of Severe Tricuspid Regurgitation: Insights From the First-in-Human Experience.

OBJECTIVES: To evaluate the long-term (≥2 years) outcomes following transcatheter tricuspid valve repair (TTVr) with the FORMA Transcatheter Tricuspid Valve Repair System (Edwards Lifesciences, Irvine, California). BACKGROUND: Scarce data exist on long-term outcomes following TTVr. METHODS: This multicenter experience included patients with severe tricuspid regurgitation (TR) who underwent TTVr with the FORMA system at 4 centers under a compassionate clinical use program. Data were collected at baseline, 30 days, and 1 year, and yearly thereafter. RESULTS: Nineteen patients (76 ± 9 years of age, 74% women, mean EuroSCORE II [European System for Cardiac Operative Risk Evaluation] 9.2 ± 5.6%) with functional TR were included. Procedural success was achieved in 17 (89%) patients and there were no cases of 30-day mortality. At a median follow-up of 32 (interquartile range: 24 to 36) months, 4 (24%) patients had died (3 from terminal heart failure, 1 from sepsis) and 3 (18%) patients required rehospitalization for heart failure. There was 1 device-related thrombosis and 1 pulmonary embolism, both in the setting of subtherapeutic oral anticoagulation. Less than severe TR was observed at echocardiography in 67% of patients at the 2- to 3-year follow-up. Among 15 successfully implanted patients with at least 24-month follow-up, significant improvements in New York Heart Association functional class (p < 0.001), 6-min walk test (+54 m; p = 0.016) and Kansas City Cardiomyopathy Questionnaire score (+16 points; p = 0.016) were observed, compared with baseline. CONCLUSIONS: TTVr using the FORMA system showed favorable long-term safety profile in high-surgical-risk patients, with sustained functional improvement and acceptable TR reduction up to 3 years.

Transcatheter Tricuspid Valve Repair With a New Transcatheter Coaptation System for the Treatment of Severe Tricuspid Regurgitation: 1-Year Clinical and Echocardiographic Results.

OBJECTIVES: This study sought to describe the 1-year experience with the transcatheter FORMA system for severe tricuspid regurgitation (TR). BACKGROUND: Severe TR is associated with significant morbidity and mortality. Novel transcatheter therapies have been recently developed. METHODS: Eighteen patients underwent device implantation at 3 centers in Canada and Switzerland. Baseline characteristics, procedural, 30-day, and 1-year outcomes were prospectively evaluated using multimodality imaging and hemodynamic and clinical assessments. RESULTS: Procedural success was achieved in 16 (89%) patients. Unsuccessful procedures were because of right ventricular perforation requiring open surgery and device dislocation. At 1 year there were no deaths, significant arrhythmias, device infections, or dislocations. Thrombus was observed on 1 device at 4 months and there was 1 rehospitalization for heart failure. Among the 14 patients with successful device implantation and 1-year follow-up, 79% were in New York Heart Association functional class I/II (p < 0.001), the average 6-min walk test increased by 84 m (p = 0.03), and the Kansas City Cardiomyopathy Questionnaire heart failure score improved by 18 points (p = 0.02) compared with baseline. Echocardiography showed a reduction of TR from severe in 17 of 18 (94%) patients at baseline to moderate-severe or less in 11 of 16 patients (69%) by 30 days (p = 0.001) and 6 of 13 patients (46%) by 1 year (p = 0.01). The diameters of the tricuspid annulus and the right ventricle were reduced at 1 year (45.7 ± 4.8 mm to 42.1 ± 4.4 mm, p = 0.004; 54 ± 5.3 mm to 49.9 ± 4.3 mm, p = 0.02, respectively). CONCLUSIONS: Implantation of the FORMA system in high-risk patients with severe TR shows feasibility with a good mid-term safety profile. At 1 year, despite variable success in reducing echocardiographic TR grade, there were significant clinical improvements and reductions in right ventricular dimensions.

Feasibility of mobile cardiopulmonary exercise testing.

QUESTIONS UNDER STUDY: Evaluation of cardiopulmonary capacity and work ability is often done by cardiopulmonary exercise testing under laboratory conditions. Mobile CPET devices allow measurements under specific real-life conditions, i.e.: at the patient's workplace. We investigated the feasibility and validity of mobile CPET in healthy controls. METHOD: We compared oxygen uptake measured by mobile CPET (MCPET) with that by standard CPET (LCPET), and we compared oxygen uptake with markers of self-reported physical exhaustion. Twenty-two healthy subjects (15 male, 21-49 years) underwent LCPET and 6 outdoors 12-min running tests (MCPETs) at different intensities. Physical exhaustion and the time they could continue exercising (T(EX)) was reported for each level. Standard descriptive statistics were applied. RESULTS: Of 132 MCPETs, performed in 22 subjects, 128 (97%) were of suitable quality. The facemask was well tolerated and nobody felt uncomfortable at any time. On average VO2 [peak] was 21% (SD 9%) higher with MCPET compared to LCPET (median 3.60, range [2.22, 5.14] versus median 2.63, range [1.67, 4.16] L*min(-1)), but showed a strong correlation (r2 = 0.90). MCPET-VO2 at steady state correlated with subjectively rated physical exhaustion, and with TEX. CONCLUSIONS: Out-of-laboratory MCPET was feasible, correlated with parameters of standard CPET, and correlated with markers of physical exhaustion. After validation in patients, MCPET could be used for a rational evaluation of cardiopulmonary capacity and work ability in selected patients.