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Three patients with rheumatic mitral stenosis were treated with percutaneous mitral valvotomy. A Brockenbrough catheter was advanced transseptally into the left atrium and then into the left ventricle over a long guide wire. An angle wire loop retriever was advanced through a 10 Fr straight catheter via the femoral artery into the left ventricle. The retriever was used to catch the flexible end of the long guide wire. This end of the long guide wire was then drawn out of the right femoral artery by the retriever through the straight catheter. The straight catheter was left in the descending aorta; the Brockenbrough catheter was removed and a 7 Fr balloon catheter was introduced percutaneously over the long guide wire through the femoral vein. This balloon catheter was used for interatrial septal dilatation and right femoral venous dilatation. In two patients this catheter was replaced over the long guide wire with a 9 Fr Schneider-Medintag Grüntzig catheter (3 X 12 mm diameter when inflated) and in the other by a Mansfield (18 mm diameter when inflated). The procedure was well tolerated in these three patients and there were no complications. Haemodynamic function improved, there was appreciable decrease in dyspnoea, and exercise tolerance was increased. This procedure has several advantages: the balloon is more easily positioned through the mitral valve; the stability of the balloon during inflation is improved by traction at both ends of the long guide wire; and there is the option of rapidly exchanging one balloon for a larger one over the long guide wire. This technique seems to be less arrhythmogenic and results in less blood loss because manual compression of the femoral vessels after the procedure is easier. [ABSTRACT FROM PUBLISHER]

Recently, percutaneous aortic valvuloplasty has been considered as a possible palliative procedure in elderly patients with critical valvular stenosis in whom valve replacement is deferred or contra-indicated because of high operative risk. However, the demonstration of the efficacy of such a procedure is based on immediate post dilatation haemodynamic data and clinical improvement. The purpose of this study was to evaluate the haemodynamic consequences of this procedure on the eighth day after a post procedure haemodynamic control. Thirty consecutive patients (mean age 75±8·4 years) with long-standing aortic stenosis were treated at the time of cardiac catheterization with balloon dilatation. Of these 30 patients, 24 (mean age 76±8) underwent haemodynamic evaluation eight days after the procedure.Prevalvuloplasty examination revealed a mean aortic valve gradient (MAVG) of 82±19·9 mmHg, a mean thermodilution calculated cardiac output (CO) of 3·6±0·91 min−1 and a mean aortic valve area (VA) of 0·37±0·14 cm2. Immediate postvalvuloplasty control showed a fall in MAVG to 44·5±16·7 mmHg (P≤0·001), a decrease in CO to 3·3±1·4 lmin−1 (NS) and an increase in VA to 0·60±0·35 cm2 (P≤0·01). Eighth-day haemodynamic control revealed an increase in MAVG to 71±18·8 mmHg (P≤0·001), an increase in CO to 4·1±1·3 lmin−1 (P≤0·001) and a decrease in VA down to 0·47±0·10 cm2 (P≤0·03). However, the comparison of the prevalvuloplasty data and the eighth-day haemodynamic control show: first, that the MAVG decreases from 81·8 to 71·3 mmHg (P≤0·01) but remains significant; second, the VA rises from 0·37±0·14 to 0·47±0·18 cm2 (P≤0·01) and remains within the limits of severe aortic stenosis. Real post valvuloplasty aortic valve modifications may be responsible for the slight but significant decrease of the MAVG and increase of VA on the eight-day control. However, the secondary important fall in mean aortic valve gradient and increase of valve area are probably also, in part, the consequence of a brief but considerable increase of the charge conditions superimposed to the left ventricle during the balloon inflation. Moreover, blood depletions added to arrhythmias and vaso-vagal phenomena are probably also responsible for modifications of charge conditions and, in our opinion, for the optimization of immediate post-valvuloplasty results. [ABSTRACT FROM PUBLISHER]

A prospective registry of 187 patients who underwent percutaneous coronary angioplasty with attempted long NIR stent delivery was performed. A successful stent delivery was achieved in 93% of cases with a low rate of major cardiovascular events, and 6-month follow-up showed low rates of clinical events, new revascularization procedures, and angiographic restenosis. [ABSTRACT FROM AUTHOR]

Competing Interests: Disclosure: There is no conflict of interest or other disclosures.

Purpose: Double inhibition of epidermal growth factor receptor (EGFR) using a tyrosine kinase inhibitor plus a monoclonal antibody may be a novel treatment strategy for non-small cell lung cancer (NSCLC). We assessed the efficacy and toxicity of afatinib + cetuximab versus afatinib alone in the first-line treatment of advanced EGFR -mutant NSCLC., Patients and Methods: In this phase II, randomized, open-label study, patients with stage III/IV EGFR -positive NSCLC were randomly assigned (1:1) to receive afatinib (group A) or afatinib + cetuximab (group A + C). Oral afatinib 40 mg was given once daily; cetuximab 250 mg/m² was administered intravenously on day 15 of cycle 1, then every 2 weeks at 500 mg/m² for 6 months. The primary endpoint was time to treatment failure (TTF) rate at 9 months. Exploratory analysis of EGFR circulating tumor DNA in plasma was performed., Results: Between June 2016 and November 2018, 59 patients were included in group A and 58 in group A + C. The study was ended early after a futility analysis was performed. The percentage of patients without treatment failure at 9 months was similar for both groups (59.3% for group A vs. 64.9% for group A + C), and median TTF was 11.1 (95% CI, 8.5-14.1) and 12.9 (9.2-14.5) months, respectively. Other endpoints, including progression-free survival and overall survival, also showed no improvement with the combination versus afatinib alone. There was a slight numerical increase in grade ≥3 adverse events in group A + C. Allele frequency of the EGFR gene mutation in circulating tumor DNA at baseline was associated with shorter PFS, regardless of the treatment received., Conclusions: These results suggest that addition of cetuximab to afatinib does not warrant further investigation in treatment-naïve advanced EGFR -mutant NSCLC., (©2021 American Association for Cancer Research.)

Background: Prolonged dual-antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients undergoing percutaneous coronary intervention can be challenging. We assessed the clinical safety of bare-metal stent (BMS) implantation followed by drug-coated balloon (DCB) treatment in HBR patients for whom drug-eluting stent implantation could be problematic in maintaining low ischemic event rate without increasing hemorrhagic events., Methods: The study included patients with at least 1 de novo lesion who were either under long-term anticoagulant treatment or required semi-urgent non-coronary intervention. The strategy consisted of PRO-Kinetic Energy BMS stent (Biotronik AG) implantation followed by Pantera Lux DCB (Biotronik AG) and patients were followed for up to 12 months in 37 French centers., Results: Between October 2013 and April 2015, a total of 432 patients with 623 de novo lesions who were either under long-term anticoagulant treatment (n = 300) or required semi-urgent non-cardiac surgery (n = 132) were treated by BMS plus DCB. Mean patient age was 74.1 ± 9.1 years, 76.4% were men, and 38% were diabetic. The composite primary endpoint rate (defined as target-lesion failure at 12 months) was 5.6% (95% confidence interval, 3.3-7.9). Median duration for DAPT treatment was 33 days. Hemorrhagic events, as defined by the Bleeding Academic Research Consortium, occurred in 31 patients (7.2%) and definite stent thrombosis occurred in 5 patients (1.3%)., Conclusions: The combination of BMS plus DCB intervention is safe even with a short duration of DAPT. This strategy might be an alternative to DES implantation in HBR patients if future randomized trials support this approach.

Background: Transcatheter aortic valve replacement (TAVR) is standard therapy for patients with severe aortic stenosis who are at high surgical risk. However, national data regarding procedural characteristics and clinical outcomes over time are limited., Objectives: The aim of this study was to assess nationwide performance trends and clinical outcomes of TAVR during a 6-year period., Methods: TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. Findings were further compared with those reported from the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry, which captured all TAVRs performed from January 2010 to January 2012 across 34 centers., Results: A total of 12,804 patients from FRANCE TAVI and 4,165 patients from FRANCE 2 were included in this analysis. The median age of patients was 84.6 years, and 49.7% were men. FRANCE TAVI participants were older but at lower surgical risk (median logistic European System for Cardiac Operative Risk Evaluation [EuroSCORE]: 15.0% vs. 18.4%; p < 0.001). More than 80% of patients in FRANCE TAVI underwent transfemoral TAVR. Transesophageal echocardiography guidance decreased from 60.7% to 32.3% of cases, whereas more recent procedures were increasingly performed in hybrid operating rooms (15.8% vs. 35.7%). Rates of Valve Academic Research Consortium-defined device success increased from 95.3% in FRANCE 2 to 96.8% in FRANCE TAVI (p < 0.001). In-hospital and 30-day mortality rates were 4.4% and 5.4%, respectively, in FRANCE TAVI compared with 8.2% and 10.1%, respectively, in FRANCE 2 (p < 0.001 for both). Stroke and potentially life-threatening complications, such as annulus rupture or aortic dissection, remained stable over time, whereas rates of cardiac tamponade and pacemaker implantation significantly increased., Conclusions: The FRANCE TAVI registry provided reassuring data regarding trends in TAVR performance in an all-comers population on a national scale. Nonetheless, given that TAVR indications are likely to expand to patients at lower surgical risk, concerns remain regarding potentially life-threatening complications and pacemaker implantation. (Registry of Aortic Valve Bioprostheses Established by Catheter [FRANCE TAVI]; NCT01777828)., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Operator radiation protection during percutaneous coronary angiography (CA) is a growing concern in the catheterisation laboratory (cath lab). The purpose of this study was to evaluate the efficacy of an additional mobile leaded shield on operator radiation exposure during diagnostic CA. The study involved two operators from the same cath lab and patients scheduled for diagnostic coronary catheterisation over a period of 2 months. Procedures were performed with standard radiation equipment during the first month. An additional mobile lead shield was added during the second month. Radiation exposure was measured by three dosimeters positioned on the operator's left hand, on their chest under the lead apron and on lead glasses. The intra-operator results were compared. Ninety-nine per cent of the procedures were carried out by radial access. For Operators 1 and 2, the mobile shield, respectively, decreased the radiation dose to the eyes by 43 and 33 % and to the hands by 61 and 83 %. Thorax dose was less than the minimum measurable dose (<0.01 mSv) for each operator. There was no significant difference in total procedure duration, fluoroscopy time or contrast dose required between the two groups of patients. Improved operator radiation protection is an important issue in the face of increased occupational doses. Mobile leaded shield, combined with standard preventive measures, seems to be an effective additional option to reduce the radiation exposure during diagnostic CA., (© The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Introduction: Approximately 2% of lung adenocarcinomas have BRAF (v-Raf murine sarcoma viral oncogene homolog B) mutations, including V600E and other types. Vemurafenib, dabrafenib, and sorafenib as BRAF inhibitors are currently tested in clinical trials, but access for patients is limited. The aim of this study was to document the clinical course of patients treated outside of clinical trials., Methods: We conducted a retrospective multicenter cohort study in Europe of patients with advanced BRAF-mutant lung cancer treated with known BRAF inhibitors. Data were anonymized and centrally assessed for age, gender, smoking, histology, stage, local molecular diagnostic results, systemic therapies, and survival. Best response was assessed locally by RECIST1.1., Results: We documented 35 patients treated in 17 centers with vemurafenib, dabrafenib, or sorafenib. Median age was 63 years (range 42-85); gender was balanced; 14 (40%) were never smokers; all (100%) had adenocarcinoma; 29 (83%) had V600E; 6 (17%) had other mutations; one of them had a concomitant KRAS mutation. Thirty (86%) patients had chemotherapy in the first line. Overall survival with first-line therapy was 25.3 months for V600E and 11.8 months for non-V600E. Thirty-one patients received one BRAF inhibitor, and four received a second inhibitor. Overall response rate with BRAF therapy was 53%, and disease control rate was 85%. Median progression-free survival with BRAF therapy was 5.0 months, and overall survival was 10.8 months., Conclusions: These results confirm the activity of targeted therapy in patients with BRAF-mutant lung adenocarcinoma. Further trials are warranted to study combination therapies and drug resistance mechanisms.

Introduction: The aim of this study was to investigate whether the efficacy of liraglutide observed in randomized controlled trials translates into therapeutic benefits in the French population during routine clinical practice., Methods: This observational, prospective, multicenter study included 3152 adults with type 2 diabetes who had recently started or were about to start liraglutide treatment. During 2 years of follow-up, an evaluation of the reasons for prescribing liraglutide, maintenance dose of liraglutide, changes in combined antidiabetic treatments, level of glycemic control, change in body weight and body mass index (BMI), patient satisfaction with diabetes treatment and safety of liraglutide were investigated. The primary study endpoint was the proportion of patients still receiving liraglutide and presenting with HbA1c <7.0% after 2 years of follow-up., Results: At the end of the study, 29.5% of patients maintained liraglutide treatment and reached the HbA(1c) target. Mean (±SD) HbA(1c), fasting plasma glucose concentration, body weight and BMI were significantly reduced from baseline [8.46% (±1.46) to 7.44% (±1.20); 180 (±60) to 146 (±44) mg/dL; 95.2 (±20.0) to 91.1 (±19.6) kg; 34.0 (±7.2) to 32.5 (±6.9) kg/m(2); respectively, all P < 0.0001]. Patient treatment satisfaction increased, with the mean diabetes treatment satisfaction questionnaire status version score increasing from 22.17 (±7.64) to 28.55 (±5.79), P < 0.0001. The main adverse event type was gastrointestinal, with a frequency of 10.9%, and the percentage of patients suffering ≥1 hypoglycemic episode decreased from 6.9% to 4.4%., Conclusion: The results of the EVIDENCE study suggest that the effectiveness of liraglutide in real-world clinical practice is similar to that observed in randomized controlled trials., Funding: Novo Nordisk A/S., Trial Registration: ClinicalTrials.gov identifier, NCT01226966.

Introduction: Endobronchial resection is now the standard treatment for tracheobronchial narrowing due to malignancy. The clinical and functional respiratory improvement has been evaluated previously but only in heterogeneous population., Methods: Between February 2009 and February 2011, we conducted a prospective single centre study at the University Hospital of Lille. Twenty-five patients with malignant tracheobronchial stenosis received a clinical and functional respiratory evaluation before and after a rigid bronchoscopy procedure to reduce the obstruction followed where appropriate by placement of an endobronchial stent., Results: Thirteen patients (52%) had primary lung cancer and in 12 the tumor had another origin. Nineteen patients (76%) received a stent after bronchial unblocking. Clinically, all patients felt an improvement in their dyspnea estimated by the Borg score with a median improvement of -2 points [-1; -4] following the procedure (P<0.001). In 96% the dyspnea visual analogic scale improved by 40 mm [27; 67] (P<0.0001). The FEV1 increased significantly after unblocking by 9% [-3.5; 28.5] (P<0.05). The Rint decreased significantly by -0.19 kPa/L per second [-0.06; -0.023] (P=0.001). Correlations between scales of dyspnea and spirometric values were not significant (P>0.05). The survival rate at 1 year was 29%., Conclusion: Interventional bronchoscopy decreases dyspnea. It modestly improves respiratory function and decreases the Rint. However, lung function and dyspnea scales are not correlated. No spirometry factor can predict clinical dyspnea response but an elevated Borg dyspnea scale might be a good indicator., (Copyright © 2013 SPLF. Published by Elsevier Masson SAS. All rights reserved.)

In the late 1980s, many alternative methods to coronary angioplasty were sought, among which rotational ablation was one of the most popular. With the huge development of coronary stents, this technique, however, was progressively left aside. More recently, though, rotational ablation has reappeared as a unique technique for the most calcified lesions and is used in a small but not negligible percentage of patients with success rates over 95% in recent series.

Background: Fractional flow reserve (FFR) is correlated with angiographic and intravascular ultrasound assessments of stent placement. Post-stenting FFR has been described as a good predictor of clinical events after 6 months., Objective: To evaluate the feasibility and clinical impact of targeting an FFR > 0.95 via incremental in-stent inflation pressures., Methods: In this multicenter prospective study, 100 consecutive patients underwent FFR measurement at baseline, after balloon predilatation, and after stenting with 4-atm inflation pressure increments from 8 to 20 atmospheres. Inflations were stopped when FFR increased above 0.95 and angiographic stenosis was less than 20%., Results: FFR > 0.95 was achieved in 81% of cases; this FFR target was reached at 8 atm in 47% of patients, 12 atm in 16 %, 16 atm in 15%, and 20 atm in 3%. Fifty percent of patients with adequate angiographic result had an FFR less than 0.95 and needed further higher inflations. FFR was correlated with residual stenosis when the total procedure was evaluated, and this correlation persisted when in-stent inflations alone were considered. Final FFR was significantly correlated with anginal status after 6 months., Conclusions: Angiography guided PCI does not allow optimization of FFR. Since optimal post stenting FFR is correlated to better anginal status at 6-months, this suggests that FFR guided PCI is required to achieve optimal functional results of PCI.

To assess the outcomes of direct coronary stenting (DS) using long stents and examine predictive factors of DS failure, this prospective multicenter registry included 128 consecutive patients who underwent the implantation of stents >or= 18 mm in length without balloon predilation for de novo coronary artery stenoses. Mean lesion and stent lengths were 20.7 +/- 5.4 and 21.4 +/- 3.8 mm, respectively. Rates of DS success, lesion success, and primary success were 82%, 99%, and 97.7%, respectively. At 6 months, rates of MACE and TVR were 12.5% and 6.3%, respectively. In multivariate analysis, factors predictive of DS failure vs. DS success were presence of calcifications (78% vs. 45%; P = 0.004) and reference vessel diameter (2.77 +/- 0.4 vs. 3.13 +/- 0.42 mm; P = 0.0002). DS of complex lesions with stents >or= 18 mm in length was performed safely and with a high success rate. This strategy was less successful in the treatment of small vessels and in presence of calcifications., (Copyright 2003 Wiley-Liss, Inc.)

In this intravascular ultrasound (IVUS) randomized trial we compared a strategy of direct stenting (DS) without predilation (n = 30) vs. conventional stenting with predilation (SWP) (n = 30) in patients with suitable type A or B non-calcified lesions in native vessels > or = 3 mm. Optimal deployment was achieved using angiographic criteria without interactive IVUS. The goal of our study was to determine whether stent expansion and coronary remodeling were similar. Maximal pressure inflation was comparable in the two groups (11.4 +/- 2.2 vs. 11.8 +/- 1.9 atm; NS). Stent deployment was obtained in all patients with complete apposition to the vessel wall. DS and SWP resulted in comparable lumen enlargement (5.4 +/- 2.5 vs. 5.5 +/- 2.1 mm2) with an identical mechanism: 66% of lumen enlargement was due to increased enlarged elastic membrane (EEM)-cross sectional area (CSA) (delta = 3.7 +/- 2.1 mm2 and delta = 2.4 +/- 6.8 mm2, respectively, p < 0.49) and 34% was due to a reduced P + M-CSA (delta = 0.02 +/- 6.9 mm2 and delta = 1.2 +/- 6.3 mm2, respectively, p < 0.50). We conclude that at the same maximal pressure inflation the mechanisms of stent expansion are similar in both DS and SWP groups. In this observational study, the IVUS data showed clearly under-expansion of stents in both groups in comparison with previously published CSA values (minimum stent CSA of 7.5 mm2).

The results of immediate percutaneous transluminal coronary angioplasty (PTCA) (260 +/- 167 minutes after onset of pain and an average of 56 minutes after thrombolysis) and deferred PTCA (average 9.6 days, range 1 to 30 days after infarction) were compared in 118 consecutive patients with acute myocardial infarction. The overall primary success rate of PTCA was 82.2 per cent; it was higher in those patients undergoing deferred angioplasty (96% vs 78%; p less than 0.05). The primary success rate of immediate PTCA was related to the severity of the stenosis before dilatation: 75 per cent success in occluded compared to 84 per cent in suboccluded vessels (over 90% stenosis) and 100 per cent success in vessels with under 90 per cent stenosis. Eighty one per cent of failed angioplasties occurred in patients with occluded arteries, the majority being left anterior descending (LAD) arteries (71.4%). The incidence of restenosis was 13.4 per cent. This complication was diagnosed at coronary arteriography performed 40 days after PTCA in 1 case, 47 days after PTCA in another case and at the 6 month control in 11 cases. Reocclusion was observed in 21 patients (21.7% of immediate successes). The occlusion was diagnosed at the first control after an average of 8 days in 15 cases. The interval between the onset of pain and thrombolysis and dilatation was significantly longer in the group with reocclusion compared with patients without reocclusion (314 minutes vs 193 minutes for thrombolysis, p less than 0.01; and 356 minutes vs 204 minutes fort PTCA, p less than 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)

Twenty patients in a stable condition suffering from congestive heart failure were treated with digoxin for at least three weeks and then with nicardipine concomitantly for five days. No statistically significant variation in serum digoxin concentrations determined at seven control times during a 24-hour period or in its mean concentration was found in the two groups of values examined before and after the concurrent nicardipine treatment. The mean increase of 6.8% in the AUC0----24h was not significant either. Since the maximum increase in serum digoxin concentrations at the steady state never exceeded 0.5 ng/ml, a toxic effect is not likely to occur in patients whose digoxin levels are normally monitored.

Identification of auricular activity is important for the diagnosis of arrhythmias. P waves however are often difficult to recognize. Using M-mode and 2-D echocardiographic techniques, it is often possible to recognize atrial contraction at the level of the atrial septum or of the free wall of the right atrium. Diagnosis can be made in cases of sinus tachycardia, supra ventricular tachycardia with and without aberrancy and ventricular tachycardia with dissociation. Ventricular tachycardia with one to one retrograde conduction or with atrial fibrillation cannot be recognized by this method.

Numerous studies have been devoted to the effect of slow calcium channel inhibitors on plasma digoxin concentrations. The principal drugs tested, verapamil and nifedipine, were found to increase significantly plasma digoxin levels mainly by reducing digoxin total clearance. Very few studies on the nicardipine-digoxin interaction have been reported. The dual purpose of the present study was to evaluate the influence of orally administered nicardipine on plasma digoxin concentrations over 24 hours and to measure possible variations in the pharmacodynamic effects of digoxin in 9 patients with chronic congestive heart failure. The pharmacodynamic assessment involved simple and cross-sectional echocardiography, systolic time interval measurements and cardiac catheterization. In these patients under chronic digoxin treatment, oral nicardipine had little effect on plasma digoxin concentrations which increased but not significantly; no sign of digitalis toxicity was observed. Nicardipine improved left ventricular function and myocardial contractility by reducing after-load, the nicardipine-induced peripheral vasodilatation tending to counteract the digoxin-induced vasoconstriction.

In about 50% of the cases, the carcinoid syndrome is complicated with cardiac lesions. These predominate in the right heart and consist of tricuspid and/or pulmonary valve disease, and endocarditis of the right atrium or ventricle. Two-dimensional echocardiography provides and early and accurate diagnosis of these lesions, so that surgical correction, if possible, can be performed before right cardiac failure with its high mortality rate develops.

Two rare mechanical complications of right ventricular infarction are reported: myocardial dissection and rupture of the RV free wall. The diagnosis was made by 2D echocardiography in both cases. Myocardial dissection resulted in the formation of an oblong, expansive, intraparietal space. The rupture of the RV free wall was visualised as a breach of the continuity of the ventricular wall. These cases underline the importance of 2D echocardiography in the acute phase of myocardial infarction for the diagnosis of these complications.