Position paper of French Interventional Group (GACI) for TAVI in France in 2018.

Aortic stenosis is a frequent disease in the elderly. Its prevalence is 0.4% with a sharp increase after the age of 65, and its outcome is very poor when the patient becomes symptomatic. The interventional procedure known as TAVI (trans-catheter aortic valve implantation), which was developed in France and carried out for the first time in Rouen by Prof. Alain Cribier and his team in 2002, has proven to be a valid alternative to surgical aortic valve replacement. At first, this technique was shown to be efficient in patients with contra-indications to surgical treatment or deemed to be at high surgical risk. Given the very promising outcomes achieved as a result of close heart team collaboration, appropriate patient selection, simplified procedures and reduced complication rates, transfemoral (TF) TAVI is now preferred in symptomatic intermediate risk patients>75 years old according to the latest ESC guidelines. In 2017, in France, TAVI is currently performed in 50 centers with on-site cardiac surgery. The 2016 TAVI outcomes recorded in the French national TAVI registry (France TAVI) are very encouraging and show that for 7133 patients treated (age 83.4±7 years, logistic Euroscore 14%), 87% of whom via the TF approach, cross-over to surgery was very low (0.5%) with a 3.0% in-hospital mortality rate. The substantial increase in TAVI indications and the improvement of its outcomes may in the near future call for a reconsideration of the number of high volume centers authorized to carry out this technique.

Treatment of drug-eluting stents in-stent restenosis with paclitaxel-coated balloon angioplasty: Insights from the French "real-world" prospective GARO Registry.

BACKGROUND: Data about paclitaxel-eluting balloon (PCB) angioplasty to treat drug-eluting stents (DES) in-stent restenosis (ISR) were mainly collected in selected patient populations in the setting of randomized trials. The main goal of this prospective registry was to confirm the positive findings of these studies in an unselected population in clinical practice. METHODS: Consecutive patients with DES-ISR treated by PCB angioplasty were recruited in this prospective real-world registry. The primary endpoint was clinically driven target-lesion revascularization (TLR) at 9 months. Secondary endpoints included acute technical success, in-hospital outcomes, 9-month major adverse cardiac events (MACE) a composite of death, myocardial infarction (MI) and TLR and the occurrence of target vessel revascularization. RESULTS: A total of 206 patients (67.7 ± 10.2 years, 80.6% male, 41.3% diabetics) with 210 lesions were recruited. Unstable coronary artery disease was present in 55.3% of patients. The time from DES implantation to DES-ISR was 3.0 ± 2.4 years. Quantitative analyses revealed that patterns of treated DES-ISR were focal in 55.7% and diffuse in 44.3%. The reference diameter was 2.76 ± 0.64 mm. The 9-month follow-up rate was 90.8% (187/206). At 9 months, the TLR rate was 7.0% (13/187) whereas the rates for MACE, MI and cardiac death were 10.7% (20/187), 4.8% (9/187) and 2.1% (4/187) respectively. Results were consistent in patients with paclitaxel and non-paclitaxel-eluting stents (PES) ISR. CONCLUSION: This large prospective registry demonstrated acceptable rates of TLR and MACE at 9 months after treatment of DES-ISR by PCB angioplasty. PCB angioplasty was equally effective in patients with PES-ISR and non PES-ISR.

Increased prevalence of psoriasis in patients with coronary artery disease: results from a case-control study.

BACKGROUND: The incidence of myocardial events has been reported to be increased in patients with psoriasis. OBJECTIVES: To investigate whether psoriasis is an independent risk factor for coronary artery disease (CAD). METHODS: We compared the prevalence of psoriasis between case patients with a diagnosis of CAD based on coronary angiography findings and control patients with no CAD referred to the emergency surgery department for an acute noncardiovascular condition. Case and control patients were examined for the presence of psoriasis by two dermatologists. The prevalence of psoriasis was compared among patients with CAD according to CAD severity. Five-hundred cases and 500 age- and sex-matched controls were included. RESULTS: Using matched univariate analysis, the prevalence of psoriasis was about twofold higher in CAD case patients than in control patients [8·0% vs. 3·4%, odds ratio (OR) 2·64; 95% confidence interval (CI) 1·42-4·88]. Using unconditional multivariate analysis, the association of psoriasis with CAD appeared to be borderline significant (OR 1·84; 95% CI 0·99-3·40). Psoriasis in patients with CAD was significantly associated with three-vessel involvement relative to one-or two-vessel involvement (13·1% vs. 6·1%; OR 3·07; 95% CI 1·50-6·25). CONCLUSIONS: The prevalence of psoriasis is twofold higher in patients with CAD than in control patients without CAD. It is associated with a more severe coronary artery involvement.

[Percutaneous treatment of aortic stenosis]. / Traitement percutané du rétrécissement aortique.

Degenerative aortic stenosis is the most frequent valvular disease in developed countries. The reference treatment is surgical valve replacement but one third of the patients are not eligible for surgery. Alternative options have been recently proposed using transcatheter valve implantation (transfemoral or trans-apical approaches) in this subset of patients. Two models of valve (balloon expandable or self-expandable) have demonstrated their efficacy and have been implanted to date in over 4000 patients worldwide. These techniques are promising but several issues remain such as the selection of patients, and the safety and durability of the devices currently used.

[Revascularisation of unprotected left main coronary artery disease: an update]. / Revascularisation du tronc commun coronaire gauche non protégé.

Coronary bypass grafting is the reference treatment of unprotected left main coronary disease. Nevertheless, the experience of invasive cardiologists and the introduction of active stents make angioplasty possible in selected cases. Only the results of controlled clinical trials (SYNTAX trial currently under way) will enable physicians to choose the most appropriate method of revascularisation for their patients.

[Intra-stent restenosis following implantation of a bare endoprosthesis]. / Resténose intra-stent après implantalion d'une endoprothèse nue.

The aim of this retrospective study was to evaluate the immediate and long-term results of various treatments for patients with a primary lesion of intra-stent restenosis (ISR). The study included 214 patients (233 endoprostheses, site of a primary ISR), with an average age of 61+/-11 years. These patients had received one of the following treatments: balloon angioplasty alone (101 patients), implantation of a second endoprosthesis (32 patients), medical treatment (65 patients), or revascularisation surgery with aorto-coronary bypass (16 patients). After retrospective analysis of the initial data, clinical follow-up was studied for all patients, and severe cardiac events were recorded. The immediate treatment of the ISR with angioplasty or bypass had an initial success rate of 100%. At the end of follow up (26+/-1.8 months) for the series as a whole, 9 patients (4.1%) had died, 7 (3.2%) had suffered a myocardial infarction, and 22 (10.3%) had had to undergo a secondary revascularisation procedure. 111 (52%) patients had angiographic follow up. A second ISR was noted in 43 cases (39%). The type of treatment provided was not a predictive factor for the occurrence of a severe cardiac event. In conclusion, whatever treatment of ISR is used, the immediate result is satisfactory. The rate of severe cardiac events is acceptable and in 10.3% of cases necessitates a secondary revascularisation procedure within 2 years. The very promising recent development of new active endoprostheses could alter the management of coronary patients in the years to come.

[Treatment of intrastent restenosis]. / Traitement de la resténose intra-stent.

In-stent restenosis (ISR) remains an important limitation after stent implantation occurring in 20-30% of patients. Different techniques and treatments have been evaluated in this setting. Repeat balloon angioplasty alone has been rapidly followed by ablative techniques such as laser, rotational atherectomy or implantation of a second stent within the stent. Cutting balloon represents another alternative technique. None of these techniques has proven its superiority over plain balloon angioplasty alone. Brachytherapy is the only effective treatment for ISR by significantly decreasing recurrent restenosis rate at follow-up. However, its use is limited by cost and infrastructure associated with the risk of late thrombosis requiring prolonged antiplatelet therapy. Surgical treatment can be proposed in recurrent ISR as well as medical therapy alone in pauci-symptomatic patients. New drug-eluting stents are under evaluation in this indication.

[First human transcatheter implantation of an aortic valve prosthesis in a case of severe calcific aortic stenosis]. / Première implantation humaine d'une valve aortique artificielle par voie percutanée dans un cas de rétrécissement aortique calcifié.

A percutaneous implantable prosthetic heart valve was developed, and after animal studies, the first human case was performed in a 57-year-old man with calcific aortic stenosis with cardiogenic shock. The implantation was performed with the use of an antegrade trans-septal approach after aortic valvuloplasty, and over a follow-up period of 4 months, the valvular function remained satisfactory. However, severe noncardiac complications occurred leading to death 17 weeks after implantation.

[In-stent restenosis: which indications for drug-eluting stent?]. / La resténose intrastent: quelles indications pour le stent actif?

In-stent restenosis remains a limitation of stent implantation. Currently, at the exception of brachytherapy, any percutaneous technique is associated with a high recurrent restenosis rate (> 50%) in diffuse in-stent restenosis. Although based on a small number of patients, eluting stents (sirolimus, paclitaxel) appear promising for the treatment of instent restenosis.

[Percutaneous revascularization of multivessel coronary disease with systematic stent implantation. Immediate results and clinical follow-up and middle term angiography]. / Revascularisation percutanée des patients multitronculaires par implantation systématique d'endoprothèses coronaires. Résultats immédiats et suivi clinique et angiographique à moyen terme.

The aim of this retrospective study was to assess the immediate and medium-term clinical and angiographic results of multiple angioplasty with stenting in 100 consecutive patients with multivessel coronary artery disease. The mean age of the population was 62 +/- 11 years. Two hundred and eight lesions were treated (2.5 +/- 0.7 per patient) with implantation of 1.14 +/- 0.4 stents per lesion. The angiographic success rate was 98.7%. There were 5 major complications in the hospital period: 3 deaths, including 2 of cardiac causes, one coronary bypass procedure and one Q wave myocardial infarction. During follow-up (17 +/- 6 months), eight patients died (5 of cardiac causes) and secondary revascularisation procedures were required in 22 patients. At 6 months, the angiographic restenosis rate was 32% per lesion, 28.8% per stent and 33 patients had at least one restenosis.

[Curative treatment of restenosis]. / Traitement curatif de la resténose.

It has been clearly demonstrated that post-angioplasty restenosis is the result of the combination of three distinct mechanisms associated to different degrees: constrictive remodelling, neo-intimal hyperplasia and elastic recoil. In contrast, after stent implantation, constrictive remodelling is nil, elastic recoil is very mild and restenosis, when observed, is essentially due to a reaction of intimal hyperplasia. These physiopathological features are important as they affect the therapeutic opportunities. With rates of stent implantation attaining 100% in some centres, intra-stent restenosis is a new pathology which poses serious problems in everyday practice as the best management of this situation has not yet been determined. For a long time, redilatation with a balloon catheter was the only possible solution. Secondarily, ablative techniques were evaluated, such as rotational and laser atherectomy, techniques with the theoretic advantage of eliminating part of the intimal proliferation. Directional atherectomy has also been used by some groups. More recently, other approaches, such as implantation of a second stent inside the first, the cutting balloon and radiotherapy, have been suggested. A surgical option is always possible in cases of repeat and/or diffuse restenosis. Finally, abstention from any local treatment may be justified in asymptomatic patients. These different approaches are discussed in this paper.

Percutaneous mechanical mitral commissurotomy with a newly designed metallic valvulotome: immediate results of the initial experience in 153 patients.

BACKGROUND: Percutaneous balloon valvotomy has become a common treatment of mitral stenosis, but the cost of the procedure remains a limitation in countries with restricted financial resources, leading to a frequent reuse of the disposable catheters. To overcome this limitation, a reusable metallic valvotomy device has been developed with the goals of both improving the mitral valvotomy results and decreasing the cost of the procedure. METHODS AND RESULTS: The device consists of a detachable metallic cylinder with 2 articulated bars screwed onto the distal end of a disposable catheter whose proximal end is connected to an activating pliers. By the transseptal route, the device is advanced across the valve over a traction guidewire. Squeezing the pliers opens the bars up to a maximum extent of 40 mm. The clinical experience consisted of 153 patients with a broad spectrum of mitral valve deformities. The procedure was successful in 92% of cases and resulted in a significant increase in mitral valve area, from 0.95+/-0.2 to 2. 16+/-0.4 cm2. No increase in mitral regurgitation was noted in 80% of cases. Bilateral splitting of the commissures was observed in 87%. Complications were 2 cases of severe mitral regurgitation (1 requiring surgery), 1 pericardial tamponade, and 1 transient cerebrovascular embolic event. In this series, the maximum number of consecutive patients treated with the same device was 35. CONCLUSIONS: The results obtained with this new device are encouraging and at least comparable to those of current balloon techniques. Multiple uses after sterilization should markedly decrease the procedural cost, a major advantage in countries with limited resources and high incidence of mitral stenosis.

Primary stenting of de novo lesions in small coronary arteries: a prospective, pilot study.

Technical advancement and new anti-thrombotic regimens have recently shown so much improvement in the results of coronary stenting that the conventional contra-indication for stenting in small coronary arteries (<3 mm) needs to be revised. We undertook a prospective pilot study of elective Palmaz-Schatz stenting in de novo lesions located in coronary arteries of less than 3 mm diameter. Fifty consecutive patients (63 +/- 9 years) with stable (n = 38) and unstable angina (n = 12) were included. Philips-DCI quantitative coronary analysis was used to measure reference diameter, minimal lumen diameter and percent diameter stenosis before PTCA, after stenting and at 6-month angiographic follow-up study. All measurements were performed after intracoronary injection of nitroglycerin (300 microg). All patients received ticlopidine (250 mg/day) and aspirin (100 mg/day). The mean lesion length was 9 +/- 3 mm. The balloon size used for stent delivery was 2.75 mm in 30 patients and 2.5 mm in 20 patients and the mean balloon inflation pressure used for stent deployment was 12 +/- 2 atm. All stents were deployed successfully. In-hospital complications occurred in two patients, diagonal branch occlusion at day 2 requiring emergency PTCA in one and a hematoma at the femoral puncture site requiring surgery in the other. Major adverse cardiac event (MACE) rate remained 2% (nonfatal infarct in one). Follow-up angiography (n = 46, 92%) at 6 +/- 3 months showed a 30% restenosis rate. Target vessel revascularization (TVR) rate was 13%. We conclude that elective stenting in small coronary arteries is feasible and involves an acceptable risk of restenosis.

[Percutaneous coronary angioscopy in the diagnosis of cardiac graft coronary disease: comparison with the results of angiography]. / Place de l'angioscopie coronaire percutanée dans le diagnostic de la maladie coronaire du transplanté. Comparaison avec l'angiographie.

Coronary disease in cardiac transplant patients is a major factor in the limitation of long term survival. The aim of this study was to compare the results of angioscopy with those of coronary angiography performed systematically every 18 months in our center. Twenty-nine patients (31 angioscopies) were assessed 38 +/- 21 months after transplantation. The appearance observed by angioscopy were: 1) normal, 2) yellow pigmentation of the arterial surface, 3) elevated plaque < 50%, 4) elevated plaque > or = 50% stenosis. Angiography was: 1) normal, 2) iregularities of the lumen or < 50% stenosis, 3) > or = 50% stenosis. The films were viewed by two independent investigators. Angioscopy was performed on the left anterior descending artery (N = 35), the left circumflex (N = 24) and the right coronary artery (N = 9). One to three arterial segments were examined per vessel (total of 117 segments: average 3.8 segments per patient). Angioscopy was uniterpretable in 13/117 (11%) of cases. Of the 81 (78%) segments considered normal at coronary angiography, only 55 seemed normal at angioscopy (68%). Of the 23 segments considered to be abnormal at coronary angiography, all were also considered to be abnormal at angioscopy. The authors conclude that coronary angioscopy seems to be more sensitive than coronary angiography for the detection of coronary disease due to chronic rejection. Prospective studies are required to determine whether the infra-angiographic angioscopic lesions correspond to earlier stages of coronary disease of the cardiac graft.

One-month results of coronary stenting in patients > or = 75 years of age.

Coronary artery bypass operations are associated with increased morbidity and mortality in the elderly. Similarly, it has been shown that coronary angioplasty is associated with a higher risk of complications in the elderly than in younger patients. The purpose of this study was to evaluate the 1-month outcome of elderly patients (>75 years old) who were included in the Stenting without Coumadin French Registry. From December 1992 to March 1995, 2,900 patients (mean age 61+/-11 years) were included in this registry. All patients were treated with ticlopidine (250 to 500 mg/day) for 1 month from the day of percutaneous transluminal angioplasty, aspirin (100 to 250 mg/day) for >6 months, and low-molecular-weight heparin (antiXa 0.5 to 1 IU/ml) for 1 month in phase II, 15 days in phase III, and 7 days in phase IV. No heparin was given in phase V. The study group included 233 patients (8.0%) > 75 years old (mean age 79+/-4), 44 (18%) of whom were women. All patients underwent dilatation of a native coronary vessel. One hundred seventeen had unstable angina (50.2%), 20 had postmyocardial infarction ischemia (8.6%), and 6 had acute myocardial infarction (2.6%). Indications for stenting were de novo lesion in 63 patients (27.0%), restenosis in 38 (16.3%), suboptimal result in 48 (20.6%), nonocclusive dissection in 56 (24.0%), and occlusive dissection in 28 (12.0%), respectively. Stented coronary arteries were the left anterior descending in 109 (46.8%), the right in 80 (34.3%), the left circumflex in 40 (17.2%), and the left main in 4 (1.7%). Palmaz-Schatz stents were used in 228 patients (82.0%), AVE microstents in 38 (13.7%), and other stents in 12 (4.3%). More than 1 stent was used in 48 patients (17.3%). The mean diameter of the balloon used for stenting was 3.31+/-0.38 mm and maximal inflation pressure was 12.2+/-2.9 atm. At one-month follow-up, vascular complications occurred in 5 patients, requiring surgery in 2 (1.3%), acute closure occurred in 1 (0.4%), subacute closure in 3 (1.3%), emergency or planned coronary artery bypass graft surgery in none, acute myocardial infarction in 4 (1.7%), stroke in 1 (0.4%), and death in 8 (3.4%). The composite end point of a major cardiac event was observed in 13 cases (5.6%). Coronary stenting using ticlopidine and aspirin appears to be a particularly safe approach in this high-risk subset.

Angioscopic evaluation of rotational atherectomy followed by additional balloon angioplasty versus balloon angioplasty alone in coronary artery disease: a prospective, randomized study.

OBJECTIVES: This study sought to compare, by angioscopy, the morphologic changes induced by rotational atherectomy, followed by additional angioplasty, with those observed after balloon angioplasty alone. BACKGROUND: Rotational atherectomy and balloon angioplasty act by different mechanisms, which could explain the difference in morphologic changes induced by these two techniques. METHODS: The study group included 50 patients with 50 lesions who were randomly assigned to undergo rotational atherectomy (n = 24) or balloon angioplasty (n = 26). Rotational atherectomy with a single burr (approximately equal to 70% of coronary diameter) was systematically followed by additional balloon angioplasty. Angioscopy was performed immediately after the procedure. Abnormal angioscopic findings were 1) flaps, graded from 1 to 3 (1 = intimal flap; 2 = flap protruding into < 50% of the lumen; 3 = flap protruding into > or = 50% of the lumen); 2) thrombi, graded from 1 to 3 (1 = flat deposits; 2 = protruding but nonocclusive thrombus; 3 = occlusive thrombus); 3) subintimal hemorrhage; 4) longitudinal dissection. The two groups were comparable for clinical and angiographic baseline data. RESULTS: On angioscopy, flaps were observed less frequently after rotational atherectomy followed by additional balloon angioplasty (8 [33%] of 24 lesions) than after balloon angioplasty alone (14 [54%] of 26 lesions, p = 0.08) and were also less severe (grade 1 in 6 lesions, grade 2 in 2 and grade 3 in none vs. grade 1 in 4 lesions, grade 2 in 5 and grade 3 in 5). Longitudinal dissections were also significantly less frequent: one versus six (p = 0.05). There was no difference in the incidence of angioscopic thrombi (p = 0.16) or subintimal hemorrhage (p = 0.15), but the power to detect a significant difference was low for these variables (37% and 26%, respectively). CONCLUSIONS: Rotational atherectomy followed by additional balloon angioplasty leads to fewer angioscopic dissections and a trend toward fewer intimal flaps than balloon angioplasty alone. However, our angioscopic differences did not lead to an outcome difference between the two groups.

[Peripheral and coronary artery dissections in a young woman. A rare case of type IV Ehlers-Danlos syndrome]. / Dissections artérielles périphériques et coronaires chez une femme jeune. Un cas exceptionnel de syndrome d'Ehlers-Danlos de type IV.

Spontaneous coronary dissection is rare and the diagnosis is usually post-mortem. Less than 60 cases have been diagnosed at coronary angiography. The authors report, to the best of their knowledge, the first case of multiple spontaneous coronary artery dissections in a type IV Ehlers-Danlos syndrome in a young woman admitted to hospital for acute myocardial infarction. She had a previous history of regressive complete tetraplegia due to dissection of the basilar artery and episodes of dizziness related to a dissecting aneurysm of the left vertebral artery. The diagnosis of type IV Ehlers-Danlos syndrome was established after skin biopsy had shown typical histological changes. The patient died several months later after an acute abdominal syndrome probably related to dissection of the aorta. An autopsy was refused by her family. The authors believe this to be the first case of spontaneous coronary dissection related to a type IV Ehlers-Danlos syndrome.