Safety and Efficacy of Mini-invasive left atrial appendage closure : a propensity score analysis.

BACKGROUND: Left atrial appendage closure (LAAC) for stroke prevention is validated in patients with non-valvular atrial fibrillation (NVAF) contraindicated to oral anticoagulation. General anesthesia (GA) is often used for procedural guidance by trans-oesophageal echocardiography (TEE); however, its use may be challenging in some patients. The aim of the study was to evaluate the safety and the mid-term efficacy of a mini-invasive LAAC strategy using micro-TEE under procedural sedation. METHODS: Comparison by propensity score of two cohorts of consecutive patients who underwent LAAC: standard TEE-guided LAAC (3D-TEE under GA) and, mini-invasive LAAC strategy (micro-TEE under procedural sedation). The primary endpoint was a composite of embolic or bleeding events, significant per-procedural complication, and cardiovascular deaths within 3 months after LAAC. RESULTS: In total, 432 patients were included (78.7±8 years old, 32.4% of women, CHA2DS2VASC score:4.9±1.1); 127 patients underwent mini-invasive LAAC strategy and were compared to 305 patients standard TEE-guided LAAC. The mini-invasive strategy was acheived in 122/127 (96.1%) planned patients. The primary endpoint occurred in 11.2% of patients from the mini-invasive LAAC strategy group and in 10.3% of patients from the standard TEE group (absolute difference = 0.9%[-6.4; 4.5], hazard-ratio=1.11[0.56; 2.19], p=0.76). Procedural times, fluoroscopy duration and hospital stays were shorter in the mini-invasive LAAC strategy group (p<0.001). CONCLUSIONS: The mini-invasive LAAC strategy is safe and effective compared to the standard TEE-guided LAAC strategy. A mini-invasive LAAC strategy may also be an important tool to help physicians to treat more patients as LAAC indications evolve in the future.

Reducing length of stay after transfemoral transcatheter aortic valve implantation: the FAST-TAVI II trial.

BACKGROUND AND AIMS: The length of stay (LOS) after transcatheter aortic valve implantation (TAVI) remains extremely variable whereas early discharge has been shown to be feasible and safe. The study objective was to evaluate the efficacy and safety of an intervention aimed at reducing LOS after transfemoral TAVI. METHODS: FAST-TAVI II is a prospective, multicentre, cluster, randomized, controlled study including patients with severe symptomatic aortic stenosis, who had transfemoral TAVI. The intervention consisted in a dedicated training programme to implement 10 quality of care measures to reduce LOS with an implementation phase of eight weeks. The primary endpoint was the proportion of patients discharged early within 3 days. Secondary endpoints included: LOS, 30-day mortality and 30-day incidence of readmission for cardiovascular events. RESULTS: During the study period, 969 patients were enrolled in the intervention group and 860 patients in the control group. Mean age was 81.9 ± 6.6 years and mean EuroSCORE II was 4.4 ± 4.5%. Early discharge was achieved in 563 (58.1%) patients in the intervention group vs. 364 (42.3%) patients in the control group (P < .0001). Median LOS was significantly reduced in the intervention group compared to the control group [3 (IQR: 3) vs. 4 days (IQR: 3), P < .0001]. Thirty-day mortality was low and similar in the two groups (0.5% vs. 0.9%, P = .30), as were 30-day readmissions (4.6% vs. 2.8%, P = .28). CONCLUSIONS: The intervention was simple and fast to implement, and was effective and safe to reduce LOS and increase the proportion of patients discharged early after TAVI (NCT04503655).

One year results of coronary bifurcation revascularization with the re-POT provisional sequential technique. The CABRIOLET registry.

BACKGROUND: Re-POT (proximal optimization technique (POT)) is a simple provisional sequential technique for percutaneous coronary bifurcation revascularization with better arterial geometry respect compared to classical techniques. Re-POT has demonstrated excellent mechanical and short-term clinical results. The multicenter CABRIOLET registry (NCT03550196) evaluate the long-term clinical benefit of the re-POT sequence in non-selected patients. METHODS: All consecutive patients presenting a coronary bifurcation lesion for which provisional stenting was indicated were included in 5 european centers. Re-POT strategy was systematically attempted. The primary endpoint was target lesion failure (TLF), comprising cardiac death, myocardial infarction, stent thrombosis and target lesion revascularization (TLR) at 12 months' follow-up. The secondary endpoints were the individual components of the primary endpoint, all-cause death, target vessel failure (TVF) and target vessel revascularization (TVR). Complex bifurcation was defined as Medina 0.1.1 or 1.1.1. RESULTS: A total of 500 patients aged 67.7 ± 11.7 years, 78.4% male, were included from 2015 to 2019, 174 of whom (34.8%) were considered having complex bifurcation lesions. Bifurcations involved the left main in 35.2% of cases. The full re-POT sequence was systematically performed in all cases. At 1 year, TLF was 2.0% (1.7% in complex vs. 2.1% in non-complex bifurcation; p = NS), and TLR was 1.6%, (1.1% vs. 1.8% respectively; p = NS). TVF and TVR rates were 3.2% and 2.8%. On multivariate analysis, only multivessel disease was predictive of TLF at 1 year (OR = 1.66 (1.09-2.53), p = 0.02). CONCLUSIONS: In this large prospective all-comer registry, provisional stenting with re-POT technique appeared safe and effective at 1 year, without anatomical bifurcation restriction.

Transfemoral versus trans-subclavian access in transcatheter aortic valve implantation using self-expandable valve: A propensity-matched comparison.

BACKGROUND: Transcatheter aortic valve implantation is unfeasible for 10-15% of patients using the conventional transfemoral approach. Other alternative approaches, such as the subclavian approach, have emerged, with no clear recommendation indicating the superiority of one technique over another. AIM: To compare the 1-month mortality and postprocedural outcomes of patients undergoing transcatheter aortic valve implantation using a self-expandable valve via transfemoral and subclavian access. METHODS: This was a retrospective single-centre study including 1496 patients who underwent transcatheter aortic valve implantation between January 2016 and December 2020 at Clermont-Ferrand University Hospital, France. Propensity score matching was used to compare transfemoral and subclavian access. RESULTS: After building two propensity score-matched groups of 221 patients each with either access route (total n=442), baseline characteristics were similar. The procedure duration was significantly longer in the subclavian access group (53 [45-64] versus 60 [51-72] minutes; P<0.001), but with a lower amount of contrast agent (138 [118-165] versus 123 [105-150] mL; P<0.001), fluoroscopy time (11.2 [9-14] versus 9.9 [7-12] minutes; P<0.001) and radiation dose (397 [264-620] versus 321 [217-485] mGy; P<0.001). No significant difference was observed concerning 1-month mortality (odds ratio 1.62, 95% confidence interval 0.52-5.03; P=0.39) or periprocedural complications. Follow-up at 1 year confirmed no difference in longer-term mortality (hazard ratio 0.78, 95% confidence interval 0.52-5.03; P=0.43). CONCLUSIONS: The subclavian approach provides similar results to the transfemoral approach in terms of mortality, efficacy and safety; it is a reasonable and effective alternative when the reference transfemoral approach is impossible or seems complex.

Right coronary artery kinking after tricuspid valve annuloplasty: a case report.

Background: Right coronary artery (RCA) injury is a rare complication of valvular surgery. However, complications should be considered, due to the significant clinical consequences. Identifying the coronary injury type and understanding the underlying pathophysiological mechanisms is essential to managing these complications. Case summary: The case of a 59-year-old man who underwent conservative mitral valve surgery with tricuspid valve annuloplasty is presented. The early post-operative period was complicated by acute coronary syndrome with inferior persistent ST-segment elevation. A coronary angiogram confirmed critical RCA hazy lesions, raising the suspicion of coronary kinking. To confirm the underlying mechanism for these lesions and determine the best treatment strategy, endocoronary imaging was performed, revealing coronary kinking of the RCA. Based on the persistent acute ischaemia, a long-lasting drug-eluting stent (DES) was implanted in the lower and upper knees of the RCA. After angioplasty, electrocardiography showed regression of the ST-segment elevation. Ten days later, coronary angiography and optical coherence tomography showed good results. The patient recovered from his myocardial infarction. Discussion: Only a few reports describe the use of endocoronary imaging for diagnosing coronary artery injury after tricuspid annuloplasty. The variety of lesion types that could underlie a single post-operative myocardial infarction makes endocoronary imaging a relevant technique to guide management strategy and optimize DES implantation.

Transcatheter aortic valve implantation with the Evolut platform for bicuspid aortic valve stenosis: the international, multicentre, prospective BIVOLUTX registry.

BACKGROUND: Prospective data about transcatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BAV) patients are limited. AIMS: We aimed to evaluate the clinical impact of the Evolut PRO and R (34 mm) self-expanding prostheses in BAV patients and explore the impact of different computed tomography (CT) sizing algorithms in a prospective registry. METHODS: A total of 149 bicuspid patients were treated in 14 countries. The primary endpoint was the intended valve performance at 30 days. Secondary endpoints were 30-day and 1-year mortality, severe patient-prosthesis mismatch (PPM) and the ellipticity index at 30 days. All study endpoints were adjudicated according to Valve Academic Research Consortium 3 criteria. RESULTS: The mean Society of Thoracic Surgeons score was 2.6% (1.7-4.2). Type I L-R BAV was observed in 72.5% of the patients. Evolut valve sizes 29 and 34 mm were utilised in 49.0% and 36.9% of the cases, respectively. The 30-day cardiac death rate was 2.6%; the 1-year cardiac death rate was 11.0%. Valve performance at 30 days was observed in 142/149 (95.3%) patients. The mean aortic valve area post-TAVI was 2.1 (1.8-2.6) cm2, and the mean aortic gradient was 7.2 (5.4-9.5) mmHg. No patient had more than moderate aortic regurgitation at 30 days. PPM was observed in 13/143 (9.1%) surviving patients and was severe in 2 patients (1.6%). Valve function was maintained at 1 year. The mean ellipticity index remained 1.3 (interquartile range 1.2-1.4). Overall, 30-day and 1-year clinical and echocardiography outcomes were similar between the two sizing strategies. CONCLUSIONS: BIVOLUTX demonstrated a favourable bioprosthetic valve performance and good clinical outcomes after TAVI with the Evolut platform in patients with bicuspid aortic stenosis. No impact from the sizing methodology could be identified.

Post-Dilatation of New-Generation Self-Expandable Transcatheter Aortic Valves Does Not Increase Atrioventricular Conduction Abnormalities.

The impact that post-dilatation has on the risk of experiencing conduction disorders after post-transcatheter aortic valve replacement with self-expanding valves (SE-TAVR) is unclear. We compared the rate of developing an atrioventricular (AV) high-grade conduction disorder and permanent pacemaker implantation (PPI) in post-TAVR patients undergoing post-dilatation. We enrolled patients with severe symptomatic calcified aortic stenosis (CAS) who were undergoing SE-TAVR between 1 January 2016, and 19 April 2019 at a single French center. Of the 532 patients treated with SE-TAVR, 417 subjects (78.4%) received Corevalve Evolute R and 115 subjects (21.6%) received the latest-generation Corevalve Evolute Pro valve. In total, 104/532 patients (19.5%; 21.6% with Evolute R vs. 12.2% with Evolute Pro, p = 0.024) required post-dilatation. Evolut R was associated with an increased risk of post-dilatation (odds ratio 2.1 (1.01-4.33, p = 0.046)). We did not observe any post-dilatation increases in AV or in intra- and interventricular conduction disorders. In total, 26.1% of participants needed PPI within the first 30 post-procedure days (p = 0.449). Post-dilatation was not associated with a higher PPI risk (subdistribution hazard ratio 1.033 (0.726-1.471); p = 0.857). No significant differences existed between the groups in terms of one-year mortality (10.3%; p = 0.507). Post-dilatation in SE-TAVR did not increase the rate of electrical conduction disorders and PPI in the early implantation phase. The latest generation of SE-TAVR valves was associated with less need for post-dilatation.

TIcagrelor in Rotational Atherectomy to Reduce TROPonin Enhancement: The TIRATROP Study, A Randomized Controlled Trial.

BACKGROUND: Because rotational atherectomy (RA) is associated with arterial trauma and platelet activation, patients treated with RA may benefit from more potent antiplatelet drugs. The aim of this trial was to assess the superiority of ticagrelor over clopidogrel in reducing post procedure troponin release. METHODS: TIRATROP (TIcagrelor in Rotational Atherectomy to reduce TROPonin enhancement) is a multicenter double-blind randomized controlled trial that included 180 patients with severe calcified lesions requiring RA who received either clopidogrel (300 mg loading dose, then 75 mg/d) or ticagrelor (loading dose 180 mg then 90 mg twice daily). Blood samples were collected at the beginning (T0), and 6, 12, 18, 24 and 36 h after the procedure. Primary end point was troponin release within the first 24 h using area under the curve analysis (troponin level as a function of time). RESULTS: The mean age of patients was 76 ± 10 years, 35% had diabetes. RA was used to treat 1, 2 or 3 calcified lesions in 72%, 23% and 5% of patients, respectively. Troponin release within the first 24 h was similar in both the ticagrelor (adjusted mean ±SD of ln AUC 8.85 ± 0.33) and the clopidogrel (8.77 ± 0.34, p = 0.60) arms. Independent predictors for troponin enhancement were acute coronary syndrome presentation, renal failure, elevated C-Reactive protein and multiple lesions treated with RA. CONCLUSION: Troponin release did not differ among treatment arms. Our results suggest that greater platelet inhibition does not affect periprocedural myocardial necrosis in the setting of RA.

Prevalence, Management and Outcomes of Percutaneous Coronary Intervention for Coronary In-Stent Restenosis: Insights From the France PCI Registry.

BACKGROUND: Despite the evolution of stent technology, there is a non-negligible risk of in-stent restenosis (ISR) after Percutaneous coronary intervention (PCI). Large-scale registry data on the prevalence and clinical management of ISR is lacking. METHODS: The aim was to describe the epidemiology and management of patients with ≥1 ISR lesions treated with PCI (ISR PCI). Data on characteristics, management and clinical outcomes were analyzed for patients undergoing ISR PCI in the France-PCI all-comers registry. RESULTS: Between January 2014 and December 2018, 31,892 lesions were treated in 22,592 patients, 7.3 % of whom underwent ISR PCI. Patients undergoing ISR PCI were older (68.5 vs 67.8; p < 0.001), and more likely to have diabetes (32.7 % vs 25.4 %, p < 0.001), chronic coronary syndrome or multivessel disease. ISR PCI concerned drug eluting stents (DES) ISR in 48.8 % of cases. Patients with ISR lesions were more frequently treated with DES than drug eluting balloon or balloon angioplasty (74.2 %, 11.6 % and 12.9 %, respectively). Intravascular imaging was rarely used. At 1 year, patients with ISR had higher target lesion revascularization rates (4.3 % vs. 1.6 %; HR 2.24 [1.64-3.06]; p < 0.001). CONCLUSIONS: In a large all-comers registry, ISR PCI was not infrequent and associated with worse prognosis than non-ISR PCI. Further studies and technical improvements are warranted to improve the outcomes of ISR PCI.

Incidence and management of atrioventricular conduction disorders in new-onset left bundle branch block after TAVI: A prospective multicenter study.

BACKGROUND: New-onset left bundle branch block (LBBB) is one of the most frequent complications after transcatheter aortic valve implantation (TAVI) and is associated with delayed high degree atrioventricular (AV) block. OBJECTIVES: The objectives of this study were to determine the incidence of AV block in such a population and to assess the performance and safety of a risk stratification algorithm on the basis of electrophysiology study (EPS) followed by implantation of a pacemaker or implantable loop recorder (ILR). METHODS: This was a prospective open-label study with 12-month follow-up. From June 8, 2015, to November 8, 2018, 183 TAVI recipients (mean age 82.3 ± 5.9 years) were included at 10 centers. New-onset LBBB after TAVI persisting for >24 hours was assessed by electrophysiology study during initial hospitalization. High-risk patients (His-ventricle interval ≥70 ms) were implanted with a dual-chamber pacemaker recording AV conduction disturbance episodes. Patients at lower risk were implanted with an ILR with automatic remote monitoring. RESULTS: A high-grade AV conduction disorder was identified in 56 patients (30.6%) at 12 months. Four subjects were symptomatic, all in the ILR group. No complications were associated with the stratification procedure. Patients with His-ventricle interval ≥70 ms displayed more high-grade AV conduction disorders (53.2% [25 of 47] vs 22.8% [31 of 136]; P < .001). In a multivariate analysis, His-ventricle interval ≥70 ms was independently associated with the occurrence of a high-grade conduction disorder (subdistribution hazard ratio 2.4; 95% confidence interval 1.2-4.8; P = .010). CONCLUSION: New-onset LBBB after TAVI was associated with high rates of high-grade AV conduction disturbances. The stratification algorithm provided safe and valuable aid to management decisions and reliable guidance on pacemaker implantation.

Prospective, single-centre evaluation of the safety and efficacy of percutaneous coronary interventions following a decision tree proposing a no-stent strategy in stable patients with coronary artery disease (SCRAP study).

AIM: We evaluated a decision algorithm for percutaneous coronary interventions (PCI) based on a no-stent strategy, corresponding to a combination of scoring balloon angioplasty (SCBA) and drug-coated balloon (DCB), as a first line approach. Stents were used only in unstable patients, or in case of mandatory bailout stenting (BO-stent). METHODS: From April 2019 to March 2020, 984 consecutive patients, including 1922 lesions, underwent PCI. The 12-month primary end-point was a composite of major adverse cardiac events (MACE) defined as all-cause death, nonfatal myocardial infarction, nonfatal stroke, and target lesion revascularization. Patients were classified into conventional or no-stent strategy groups according to the PCI strategy. In the no-stent strategy group, they were further classified into BO-stent or DCB-only groups. Their metal index was calculated by stent length divided by the total lesion length. RESULTS: The no-stent strategy was applied in 85% of the patients, and it was successful for 65% of them. MACE occurred in 7.1% of the study population, including 4.2% of all-cause death. Target lesion revascularization was required in 1.4%, 3.6%, and 1.5% of patients in the conventional DES, BO-stent, and DCB-only groups, respectively. MACE occurred more often in the elderly and in those treated with at least one stent (metal index greater than 0). CONCLUSIONS: The no-stent strategy, i.e., revascularization of coronary lesions by SCBA followed by DCB and with DES bailout stenting, was effective and safe at 1 year. This PCI approach was applicable on a daily practice in our cath lab. TRIAL REGISTRATION: This study was registered with clinicaltrials.gov (NCT03893396, first posted on March 28, 2019). Feasibility, safety and efficacy of percutaneous coronary interventions following a decision tree proposing a no-stent strategy in stable patients with coronary artery disease. DES: drug eluting stent; SCBA: scoring balloon angioplasty; BO-stent: at least one stent; DCB: drug coated balloon; BMS: bare metal stent; Bailout (dash lines); MACE: major adverse cardiac event.

[Invasive and non-invasive imaging analysis for calcified coronary artery lesions]. / Imagerie invasive et non invasive des lésions coronaires calcifiées.

Coronary calcifications are frequently identified within coronary lesions as their incidence increases with age and cardiovascular risk factors. Their location can be superficial or deep, according to different pathological process. In all cases, the presence of calcifications within the vascular wall predicts poor clinical prognosis and unfavorable evolution after percutaneous revascularization. Coronary calcifications can be analyzed by angiography, CT or intracoronary imaging (IVUS or OCT) with variable accuracies. Angiography is the most frequently used method but is not very sensitive (sensitivity close to 50%) and insufficient for their precise quantification. The CT scan is a more effective non-invasive method leading to an accurate analysis of the lesion before coronary angiography. IVUS and OCT have an excellent spatial resolution and are the most sensitive methods for the identification (present in nearly 75-80% of lesions) and quantification of calcifications. These intracoronary imaging techniques offer interesting perspectives for identification of the highest-risk lesions, PCI procedures planning (including the choice of an optimal dedicated plaque preparation devices), the monitoring of their execution and the evaluation of the immediate post-stenting results.

Unusual interventional treatment of a complex calcified coronary artery lesion in a child with Kawasaki disease: a case report.

Background: Kawasaki disease (KD) is a medium vessel vasculitis occurring in children, as yet of undetermined aetiology. KD can lead to severe complications such as coronary artery aneurysms, thrombosis, and sudden death. Monitoring of coronary anomalies is an important issue in the early phase of the disease, and their follow-up is based on different imaging methods. The interventional treatment of these coronary anomalies, which is often complex, is a therapeutic challenge. Case summary: We are reporting the case of a four-year-old child who presented KD which was complicated by coronary aneurysm of the proximal left anterior descending artery and ectasia of the right coronary artery (RCA). These lesions progressively calcified and resulted at the age of 13 in chronic occlusion of the RCA. After confirmation of myocardial viability and myocardial ischaemia, a complex angioplasty guided by intracoronary imaging was performed using rotational atherectomy, a cutting balloon, and a high pressure balloon. The control coronary angiography performed 1 year later revealed two false aneurysm on the RCA at the angioplasty site, which were successfully treated with a covered stent. Discussion: This case report describes the challenges of treating coronary artery abnormalities such as calcified coronary lesions in children with KD. The coronary intervention of these lesions remains complex and may lead to coronary rupture. We highlight the advantage of using intracoronary imaging in the management of these calcified lesions for successful revascularization, and to assess the complications of percutaneous coronary intervention.

Emergency bailout surgery saves lives in high-risk patients with complications after TAVR.

INTRODUCTION: With the expansion of the indication for transcatheter aortic valve implantation (TAVR), the value of access to on-site emergency heart surgery at performing centers needs to be assessed. AIMS: To evaluate postoperative mortality after surgical rescue post-TAVR, in a population at high surgical risk. METHODS: Retrospective analysis of a cohort of patients included in the France-TAVI registry who had undergone TAVR with the latest generation valves between January 2017 and February 2020. RESULTS: Among the 968 patients undergoing TAVR, 6 patients (0.62%) were identified as candidates for surgery: 3 in the peri-operative context and 3 during hospitalization. Four subjects were managed in a salvage situation, two due to tamponade, one due to aortic dissection, and one due to aortic annulus rupture. One patient died of a delayed aortic annulus rupture and one patient presented a right coronary occlusion which was medically treated. All patients who underwent emergency surgery were discharged alive from the hospital. CONCLUSIONS: In TAVR patients initially contraindicated for surgery, emergency bailout surgery could be performed successfully with all patients discharged alive. Access to on-site heart surgery represents a life-saving resource for TAVR centers.

Leaflet disruption of ViV-TAVI after bioprosthetic valve fracture leading to severe aortic regurgitation: a case report.

Background: Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) has emerged as an alternative for the treatment of degenerated bioprosthetic valves (BPVs) for high surgical risk patients. However, this procedure often results in patient-prosthesis mismatch. BPV fracture is a novel technique to address this problem. From now, complications following BPV fracture are few. Case summary: We present the case of a 84-year-old female with history of first surgical aortic BPV replacement with a Mitroflow Sorin 23 mm due to severe aotic stenosis in 2009. In 2017, a second intervention due to bioprosthetic aortic valve stenosis valve was performed with valve-in-valve TAVI with CoreValve Evolut R 23 mm. In 2021, she was admitted with severe heart failure due to TAVI degeneration with severe stenosis in the bioprothesis. After heart team discussions, the patient was deemed inoperable for new heart surgery and considered as a candidate for BPV fracture as last possible alternative. After BPV fracture was performed, the patient suffered acute hypotension. Urgent transoesophageal echocardiography and angiogram demonstrated severe acute intra-TAVI aortic insufficiency because of probable disruption of the CoreValve leaflets. The patient was successfully treated with a ViV 23 mm SAPIEN three Edwards valve with a resolution of the aortic insufficiency and improvement of her haemodynamics. The patient remains asymptomatic after 6 months, with improvement in clinical status. Discussion: This case demonstrates a disruption of the transcatheter heart valve leaflets causing severe aortic regurgitation as one of the complication of BPV fracture. To our knowledge, this is the first report of a TAVI in a patient who was already operated with ViV-TAVI. Although case series described few complications with improvement in clinical status, the procedure should be established with appropriate planning and careful technique.