Aortic valve replacement for aortic stenosis: Influence of centre volume on TAVR adoption rates and outcomes in France.

BACKGROUND: Transcatheter (TAVR) has supplanted surgical (SAVR) aortic valve replacement (AVR). AIM: To evaluate whether adoption of this technology has varied according to centre volume at the nationwide level. METHODS: From an administrative hospital-discharge database, we collected data on all AVRs performed in France between 2007 and 2019. Centres were divided into terciles based on the annual number of SAVRs performed in 2007-2009 ("before TAVR era"). RESULTS: A total of 192,773 AVRs (134,662 SAVRs and 58,111 TAVRs) were performed in 47 centres. The annual number of AVRs and TAVRs increased significantly and linearly in low-volume (<152 SAVRs/year; median 106, interquartile range [IQR] 75-129), middle-volume (152-219 SAVRs/year; median 197, IQR 172-212) and high-volume (>219 SAVRs/year; median 303, IQR 268-513) terciles, but to a greater degree in the latter (+14, +16 and +24 AVRs/centre/year and +16, +19 and +31 TAVRs/centre/year, respectively; PANCOVA<0.001). Charlson Comorbidity Index and in-hospital death rates declined from 2010 to 2019 in all terciles (all Ptrend<0.05). In 2017-2019, after adjusting for age, sex and Charlson Comorbidity Index, there was a trend toward lower death rates in the high-volume tercile (P=0.06) for SAVR, whereas death rates were similar for TAVR irrespective of tercile (P=0.27). Similar results were obtained when terciles were defined based on number of interventions performed in the last instead of the first 3years. Importantly, even centres in the lowest-volume tercile performed a relatively high number of interventions (150 TAVRs/year/centre). CONCLUSIONS: In a centralized public healthcare system, the total number of AVRs increased linearly between 2007 and 2019, mostly due to an increase in TAVR, irrespective of centre volume. Progressive declines in patient risk profiles and death rates were observed in all terciles; in 2017-2019 death rates were similar in all terciles, although lower in high-volume centres for SAVR.

Impact of the coronavirus disease 2019 pandemic on aortic valve replacement and outcomes in France.

BACKGROUND: The coronavirus disease of 2019 (COVID-19) pandemic lockdowns limited access to medical care. The impact on surgical (SAVR) and transcatheter (TAVR) aortic valve replacement (AVR) has been poorly described. AIM: We sought to evaluate the impact of the COVID-19 pandemic on the number and modalities of AVR, patient demographics and in-hospital outcomes at the nationwide level. METHODS: Using the French nationwide administrative hospital discharge database, we compared projected numbers and proportions of AVR and hospital outcomes, obtained using linear regressions derived from 2015-2019 trends, with those observed in 2020. RESULTS: In 2020, 21,382 AVRs were performed (13,051 TAVRs, 5706 isolated SAVRs and 2625 SAVRs combined with other cardiac surgery). Compared with the 2020 projected number of AVRs (24,586, 95% confidence interval [CI] 23,525-25,646), TAVRs (14,866, 95% CI 14,164-15,568), isolated SAVRs (6652, 95% CI 6203-7100) and SAVRs combined with other cardiac surgery (3069, 95% CI 2822-3315), there were reductions of 13.0%, 12.2%, 14.2% and 14.5%, respectively. These trends were similar regardless of sex or age. In 2020, the mean age, Charlson Comorbidity Index and hospital admission duration continued to decline, and the proportion of females remained constant, following 2015-2019 trends. Overall, 2020 in-hospital mortality was higher than projected (2.0% observed vs. 1.7% projected; 95% CI 1.5-1.9%), with no increased pacemaker implantation, but more acute kidney injury and cerebrovascular accidents in some surgical subsets. CONCLUSIONS: During the COVID-19 pandemic, fewer TAVR and SAVR procedures were performed, with increased in-hospital mortality and periprocedural complications. Extended follow-up will be important to establish the long-term effect of the COVID-19 pandemic on patient management and outcomes.

Association of Age and Sex With Use of Transcatheter Aortic Valve Replacement in France.

BACKGROUND: Current guidelines recommend selecting surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) based on age, comorbidities, and surgical risk. Nevertheless, reports from the United States suggest a rapid expansion of TAVR in young patients. OBJECTIVES: The authors sought to evaluate the trends in TAVR uptake at a nationwide level in France according to age and sex. METHODS: Using a nationwide administrative database, we evaluated age- and sex-related trends in TAVR uptake, patient demographics, and in-hospital outcomes between 2015 and 2020. RESULTS: A total of 107,397 patients (44.0% female) underwent an isolated aortic valve replacement (AVR) (59.1% TAVR, 40.9% SAVR). In patients <65 years of age, the proportion of TAVR increased by 63.2% (P < 0.001) from 2015 to 2020 but remained uncommon at 11.1% of all AVR by 2020 (12.4% in females, 10.6% in males) while TAVR was the dominant modality in patients ≥65 years of age. In patients undergoing TAVR, the Charlson comorbidity index (CCI) (P = 0.119 for trend) and in-hospital mortality (P = 0.740 for trend) remained unchanged in patients <65 years of age but declined in those ≥65 years of age irrespective of sex (all P < 0.001 for trends). Females were older (P < 0.001), had lower CCI (P < 0.001), were more likely to undergo TAVR (P < 0.001), and experienced higher in-hospital mortality (TAVR, P = 0.015; SAVR, P < 0.001) that persisted despite adjustment for age and CCI. CONCLUSIONS: In France, the use of TAVR remained uncommon in young patients, predominantly restricted to those at high risk. Important sex differences were observed in patent demographics, selection of AVR modality, and patient outcomes. Additional research evaluating the long-term impact of TAVR use in young patients and prospective data evaluating sex differences in AVR modality selection and outcomes are needed.

Aortic Stenosis Progression: A Systematic Review and Meta-Analysis.

BACKGROUND: Aortic valve stenosis is a progressive disorder with variable progression rates. The factors affecting aortic stenosis (AS) progression remain largely unknown. OBJECTIVES: This systematic review and meta-analysis sought to determine AS progression rates and to assess the impact of baseline AS severity and sex on disease progression. METHODS: The authors searched Medline, Embase, and the Cochrane Central Register of Controlled Trials from inception to July 1, 2020, for prospective studies evaluating the progression of AS with the use of echocardiography (mean gradient [MG], peak velocity [PV], peak gradient [PG], or aortic valve area [AVA]) or computed tomography (calcium score [AVC]). Random-effects meta-analysis was performed to evaluate the rate of AS progression for each parameter stratified by baseline severity, and meta-regression was performed to determine the impact of baseline severity and of sex on AS progression rate. RESULTS: A total of 24 studies including 5,450 patients (40% female) met inclusion criteria. The pooled annualized progression of MG was +4.10 mm Hg (95% CI: 2.80-5.41 mm Hg), AVA -0.08 cm2 (95% CI: 0.06-0.10 cm2), PV +0.19 m/s (95% CI: 0.13-0.24 m/s), PG +7.86 mm Hg (95% CI: 4.98-10.75 mm Hg), and AVC +158.5 AU (95% CI: 55.0-261.9 AU). Increasing baseline severity of AS was predictive of higher rates of progression for MG (P < 0.001), PV (P = 0.001), and AVC (P < 0.001), but not AVA (P = 0.34) or PG (P = 0.21). Only 4 studies reported AS progression stratified by sex, with only PV and AVC having 3 studies to perform a meta-analysis. No difference between sex was observed for PV (P = 0.397) or AVC (P = 0.572), but the level of confidence was low. CONCLUSIONS: This study provides progression rates for both hemodynamic and anatomic parameters of AS and shows that increasing hemodynamic and anatomic baseline severity is associated with faster AS progression. More studies are needed to determine if sex differences affect AS progression. (Aortic Valve Stenosis Progression Rate: A Systematic Review and Meta-Analysis; CRD42021207726).

Trends in aortic valve replacement for aortic stenosis: a French nationwide study.

AIMS: Transcatheter aortic valve replacement (TAVR) as an alternative to surgical aortic valve replacement (SAVR) has profoundly changed the management of patients with aortic valve stenosis (AS). Large unbiased nationwide data regarding TAVR implementation, impact on SAVR and their respective outcomes are scarce. METHODS AND RESULTS: Based on a French administrative hospital-discharge database, we collected data on all consecutive aortic valve replacements (AVRs) performed in France for AS between 2007 and 2019 [106 253 isolated SAVR (49%), 46 514 combined SAVR (21%), and 65 651 TAVR (30%)]. The number of AVR linearly increased between 2007 and 2019 (from 10 892 to 23 109, P for trend < 0.0001) due to a marked increase in TAVR (from 253 to 13 030, P for trend < 0.0001), while SAVR increased up to 2013 and then declined (10 892 in 2007, 12 699 in 2013, and 10 079 in 2019). The Charlson index decreased linearly for TAVR, but in two steps for SAVR (2011 and 2017). In-hospital mortality rates of both SAVR and TAVR declined (both P for trend < 0.0001) and were similar or lower for TAVR than for isolated SAVR in patients 75 years or above in the last 3 years (2017-19). Complication rates of TAVR also declined but permanent pacemaker rates remained high and length of stay substantial (16.7% and median 6 days, respectively, in 2017-19). CONCLUSION: The number of AVR has doubled in a decade and TAVR has become the dominant form of AVR in 2018. The improvement in patient profiles seems to have anticipated the demonstrated benefit of TAVR in intermediate and low-risk patients. In patients 75 years or older, TAVR should be considered as the first option. We also highlight two important areas for improvement, the high permanent pacemaker rates, and the long length of stay even in the contemporary era. Our results may have major implications for clinical practice and policymakers.

Natural History of Mitral Annular Calcification and Calcific Mitral Valve Disease.

BACKGROUND: The natural history of mitral annular calcification (MAC) and risk for developing calcific mitral valve disease (CMVD) have been poorly defined. The aim of this study was to evaluate the progression rate of MAC and of the development of CMVD. METHODS: Patients with MAC and paired echocardiograms ≥1 year apart between 2005 and 2019 were included. Progression rates from mild or moderate to severe MAC and to CMVD (defined as severe MAC and significant mitral stenosis and/or regurgitation) were assessed, along with potential association with sex. RESULTS: A total of 11,605 patients (mean age, 73 ± 10 years; 51% men) with MAC (78% mild, 17% moderate, 5% severe) were included and underwent follow-up echocardiography at 4.2 ± 2.7 years. Among patients with mild or moderate MAC, 33% presented with severe MAC at 10 years. The rate of severe MAC was higher in women than in men (41% vs 24% [P < .001]; hazard ratio, 1.3; P < .001) and in patients with moderate versus mild MAC (71% vs 22% [P < .001]; hazard ratio, 6.1; P < .001). At 10 years, 10% presented with CMVD (4%, 23%, and 60% in patients with mild, moderate, and severe MAC, respectively), which was predicted by female sex (15% vs 5%; P < .0001), even after adjustment for MAC severity (hazard ratio, 1.9; P < .001). CONCLUSION: In this large cohort of patients with MAC, progression to severe MAC was common and frequently resulted in CMVD. Female sex was associated with higher progression rates. MAC and CMVD are expected to dramatically increase as the population ages, highlighting the importance of a better understanding of the pathophysiology of MAC to develop effective preventive medical therapies.

Trends in aortic valve replacement for aortic stenosis: a French nationwide study.

AIMS: Transcatheter aortic valve replacement (TAVR) as an alternative to surgical aortic valve replacement (SAVR) has profoundly changed the management of patients with aortic valve stenosis (AS). Large unbiased nationwide data regarding TAVR implementation, impact on SAVR and their respective outcomes are scarce. METHODS AND RESULTS: Based on a French administrative hospital-discharge database, we collected data on all consecutive aortic valve replacements (AVRs) performed in France for AS between 2007 and 2019 [106 253 isolated SAVR (49%), 46 514 combined SAVR (21%), and 65 651 TAVR (30%)]. The number of AVR linearly increased between 2007 and 2019 (from 10 892 to 23 109, P for trend < 0.0001) due to a marked increase in TAVR (from 253 to 13 030, P for trend < 0.0001), while SAVR increased up to 2013 and then declined (10 892 in 2007, 12 699 in 2013, and 10 079 in 2019). The Charlson index decreased linearly for TAVR, but in two steps for SAVR (2011 and 2017). In-hospital mortality rates of both SAVR and TAVR declined (both P for trend < 0.0001) and were similar or lower for TAVR than for isolated SAVR in patients 75 years or above in the last 3 years (2017-19). Complication rates of TAVR also declined but permanent pacemaker rates remained high and length of stay substantial (16.7% and median 6 days, respectively, in 2017-19). CONCLUSION: The number of AVR has doubled in a decade and TAVR has become the dominant form of AVR in 2018. The improvement in patient profiles seems to have anticipated the demonstrated benefit of TAVR in intermediate and low-risk patients. In patients 75 years or older, TAVR should be considered as the first option. We also highlight two important areas for improvement, the high permanent pacemaker rates, and the long length of stay even in the contemporary era. Our results may have major implications for clinical practice and policymakers.

Coronary artery ectasia: prevalence, angiographic characteristics and clinical outcome.

OBJECTIVE: Determine coronary artery ectasia (CAE) prevalence and clinical outcome in a large cohort of patients underwent coronary angiography. METHODS: In an 11-year period, between 2006 and 2017, 20 455 coronary angiography studies were performed at a large university centre. Patients diagnosed with CAE based on procedure report were included in the final analysis. RESULTS: CAE was diagnosed in 174 out of 20 455 studies (0.85% per total angiograms, 161 patients). Patients' average age was 59.6±11.2 years old with male predominance (90.7%). Diffuse ectasia morphology was most common (78.9%), followed by fusiform (16.1%) and saccular (5%). Mixed CAE and atherosclerotic heart disease (ASHD) was present in 75.2% of the patients and isolated CAE in 24.8%. The most common coronary artery involved was the right coronary artery (RCA) (79%). Following index angiography, all the isolated CAE group was managed conservatively, while 67% of the mixed CAE-ASHD group underwent coronary intervention. In an average follow-up of 6±3.6 years, adverse clinical event (a composite endpoint of any death, cerebrovascular accident, myocardial infarction, thromboembolic event, bleeding and stent thrombosis) occurred in 48.8% of the mixed CAE-ASHD group compared with 25% in the isolated CAE group (p<0.05). CONCLUSIONS: CAE is a rare phenomenon. The most common artery involved was the RCA, and the diffused type of CAE was the most frequent. Most patients with CAE have also concomitant ASHD, and those patients have higher mortality and complications rate, compared with isolated CAE disease.

Digital recording and documentation of endoscopic procedures: physicians' practice and perspectives.

BACKGROUND: In recent years, it has become increasingly prevalent internationally to record and archive digital recordings of endoscopic procedures. This emerging documentation tool raises weighty educational, ethical and legal issues - which are viewed as both deterrents and incentives to its adoption. We conducted a survey study aimed at evaluating the use of DRD in endoscopic procedures, to examine physicians' support of this practice and to map the considerations weighed by physicians when deciding whether or not to support a more extensive use of DRD. METHODS: Israeli physicians from specialties that employ endoscopic technics were surveyed anonymously for demographic background, existence and use of recording equipment, existence of institutional guidelines regarding DRD, and self-ranking (on a scale from 1 to 7) of personal attitudes regarding DRD. RESULTS: 322 physicians were surveyed. 84% reported performing routine endoscopic procedures, 78% had the required equipment for digital recording, and 64% of them stated that they never or only rarely actually recorded the procedure. General surgeons had the second highest rate of DRD equipment (96.5%) but the lowest rates of DRD practice (17.5%). The average ranking of support of DRD by all participants was 5.07 ± 1.9, indicating a moderately high level of support. Significant positive correlation exists between actual DRD rates and average support of DRD (p < 0.001). Based on mediation models, for all specialties and with no exceptions, having routine recording guidelines and positive support of DRD were found to increase the probability of actual recording. Being a surgeon or an urologist negatively correlated with support of DRD, and decreased actual recording rates. The argument "Recording might cause more lawsuits" was ranked significantly higher than all other arguments against DRD (p < 0.001), and "Recording could aid teaching of interns" was ranked higher than all other arguments in favor of DRD (p < 0.001). CONCLUSIONS: While DRD facilities and equipment are fairly widespread in Israel, the actual recording rate is generally low and varies among specialties. Having institutional guidelines requiring routine recording and a positive personal support of DRD correlated with actual DRD rates, with general surgeons being markedly less supportive of DRD and having the lowest actual recording rates. Physicians in all specialties were very much concerned about DRD's potential to enhance lawsuits, and this greatly influenced their use of DRD. These findings should be addressed by educational efforts, centering on professionals from reluctant specialties, as well as by the issuing of both professional and institutional guidelines endorsing DRD as well as requiring it where applicable.

Semaphorin 4D levels in heart failure patients: a potential novel biomarker of acute heart failure?

AIMS: Semaphorin 4D (Sema4D) is expressed on platelets and T-cells and known to be involved in inflammation. The aims of this study include comparing Sema4D and N terminal pro brain natriuretic peptide (NT-proBNP) serum levels in heart failure (HF) patients to a control group, evaluating the correlation between Sema4D and NT-proBNP levels, and assessing Sema4D serum levels in HF patients during acute exacerbation and remission. METHODS AND RESULTS: Forty-five patients diagnosed with HF (based on echocardiographic findings, positive NT-proBNP levels, and normal C-reactive protein) and 11 healthy controls (declaring no chronic diseases or medications) comprised the study population. Demographic, clinical, laboratory, and echocardiographic data were used to create the study database. NT-proBNP and Sema4D serum samples were taken on admission and discharge. NT-proBNP levels were significantly higher in the HF group than in controls (P < 0.001). Sema4D levels were significantly higher in HF patients than in healthy controls (2143.04 ± 1253 vs. 762.18 ± 581.6 ng/mL, P < 0.001, respectively). Using linear regression, a higher creatinine level was found to predict both higher levels of NT-proBNP and Sema4D (P = 0.05 and P < 0.014, respectively), while a reduced ejection fraction was found to predict higher NT-proBNP levels only (P < 0.001 and P = 0.87, respectively). Average Sema4D levels reduced significantly at remission (3534.94 ± 1650.55 vs. 2455.67 ± 1424, P = 0.03), while mean NT-proBNP levels did not change significantly. CONCLUSIONS: Sema4D levels in HF patients' serum are significantly higher than in healthy controls. Clinical improvement caused rapid reduction in Sema4D levels, possibly reflecting the inflammatory aspect of HF. These findings might suggest that Sema4D can be used as a diagnostic biomarker of acute HF. Further studies of Sema4D and HF are warranted.

Digital Recording and Documentation of Endoscopic Procedures: Do Patients and Doctors Think Alike?

Aims and Methods. Conducting a survey study of a large number of patients and gastroenterologists aimed at identifying relevant predictors of interest in digital recording and documentation (DRD) of endoscopic procedures. Outpatients presenting to the endoscopy unit at our institution for an endoscopy examination were anonymously surveyed, regarding their views and opinions of a possible recording of the procedure. A parallel survey for gastroenterologists was conducted. Results. 417 patients and 62 gastroenterologists participated in two parallel surveys regarding DRD of endoscopic procedures. 66.4% of the patients expressed interest in digital documentation of their endoscopic procedure, with 90.5% of them requesting a copy. 43.6% of the physicians supported digital recording while 27.4% opposed it, with 48.4% opposing to making a copy of the recording available to the patient. No sociodemographic or background factors predicted patient's interest in DRD. 66% of the physicians reported having recording facilities in their institutions, but only 43.6% of them stated performing recording. Having institutional guidelines for DRD was found to be the only significant predictor for routine recording. Conclusions. Our study exposes patients' positive views of digital recording and documentation of endoscopic procedures. In contrast, physicians appear to be much more reluctant towards DRD and are centrally motivated by legal concerns when opposing DRD, as well as when supporting it.

[KIDNEY DISEASES IN NORTH ISRAEL ACCORDING TO KIDNEY BIOPSIES - BNAI-ZION MEDICAL CENTER 14 YEARS' EXPERIENCE].

INTRODUCTION: Little is known about the prevalence of kidney diseases according to renal biopsy in Israel. Since updated literature worldwide emphasizes changing etiologies of chronic kidney disease, it is crucial to research and define the epidemiology and pathology of kidney disease in Israel. Hereby, we introduce an original review of the prevalence of kidney diseases in our study population, which we believe reflects the prevalence of kidney diseases in the population of Israel. AIMS: To investigate the prevalence of kidney diseases diagnosed by renal biopsy, according to age, gender, race and clinical symptoms. METHODS: A total of 155 kidney biopsies were conducted in the years 2000-2014 in Bnai-Zion Medical Center in Haifa, according to formal accepted indications. Most of the biopsies (65%) were needle aspirations in a retroperitoneal approach, in which 90% were ultrasound guided and the rest computed tomography guided, while the other 35% of biopsies involved laparoscopic approaches. RESULTS: The most common indications for kidney biopsy were nephrotic syndrome, nephritic syndrome and proteinuria (37.4%, 25.8% and 24.5%, respectively). Average glomeruli number per biopsy was 17.5 vs. 82.2 for needle aspiration and laparoscopic approach, respectively (statistically significant). The most common diagnosis was focal segmental glomerulosclerosis (FSGS), followed by chronic glomerulonephritis, IgA nephropathy, lupus nephritis, minimal change disease (MCD), membranous nephropathy and tubulointerstitial disease (20%, 11.5%, 11.5%, 10.1%, 9.5%, 8.1% and 6.1%, respectively). CONCLUSIONS: FSGS was the most common diagnosis in patients presented with nephrotic syndrome or proteinuria, men, and patients above 60 years of age. Patients below 30 years of age were mainly diagnosed with IgA nephropathy. DISCUSSION: In recent years, FSGS is becoming more prevalent compared with other chronic kidney disease especially in the older population. IgA nephropathy is still the most common diagnosis in young patients and in patients presented with hematuria. To the best of our knowledge, no data exists on the prevalence of kidney diseases in Israel, and our study is an important contribution to the epidemiological and clinical knowledge on the subject.

[SPONTANEOUS BACTERIAL EMPYEMA--A RARE BUT IMPORTANT COMPLICATION OF HEPATIC HYDROTHORAX IN CIRRHOTIC PATIENTS].

Spontaneous bacterial empyema, a complication of hepatic hydrothorax in cirrhotic patients, is a rare but nevertheless important medical entity. The diagnosis, treatment and prognosis of spontaneous bacterial empyema differs from the "usual" empyema, and avoiding proper diagnosis or treatment delay may have far reaching consequences. We report on a patient who was diagnosed in our department with spontaneous bacterial empyema, review the main current literature on the subject and elaborate on the specific therapeutic considerations related to the case management.

Almost a tragedy: severe methotrexate toxicity in a hemodialysis patient treated for ectopic pregnancy.

BACKGROUND: Methotrexate (MTX), an antimetabolite of folic acid, is the drug of choice for the nonsurgical management of ectopic pregnancy. MTX-related toxicity may include leukopenia, thrombocytopenia, pancytopenia, nausea, vomiting, stomatitis, mucositis, and liver and lung toxicity, depending primarily on the dosage of the drug and patients' renal function. Currently, the use of MTX in hemodialysis patients, even at a low dosage, is controversial, and no clear-cut guidelines are available. CASE REPORT: We report here a rare case of a life-threatening complication characterized by severe pancytopenia and skin and mucosal injury, which developed in a young patient on hemodialysis after oral treatment with MTX for ectopic pregnancy. CONCLUSION: We conclude that even low-dose MTX administration is not to be used in patients with renal insufficiency, and when no other therapeutic options are available we suggest taking several clinical measures to prevent or treat myelosuppression.