Oral anticoagulant treatment after bioprosthetic valvular intervention or valvuloplasty in patients with atrial fibrillation—A SWEDEHEART study

Aims To describe the prevalence of atrial fibrillation (AF), use of oral anticoagulants (OAC) and change in antithrombotic treatment patterns during follow-up after valve intervention with a biological prosthesis or valvuloplasty. Methods and results All patients with history of AF or new-onset AF discharged alive after valvular intervention (biological prosthesis or valvuloplasty) between 2010–2016 in Sweden were included (n = 7,362). Information about comorbidities was collected from national patient registers. Exposure to OAC was based on pharmacy dispensation data. In total 4,800 (65.2%) patients had a history of AF, and 2,562 (34.8%) patients developed new-onset AF, with 999 (39.0%) developing new-onset AF within 3 months after intervention. The proportion of patients with biological valve prosthesis was higher in patients with new-onset AF compared to history of AF (p<0.001). CHA2DS2-VASc score ≥2 was observed in 83.1% and 75.5% patients with history of AF and new-onset AF, respectively. Warfarin was more frequently dispensed than NOAC at discharge in patients with history of AF (43.9% vs 7.3%), and in patients with new-onset AF (36.6% vs 17.1%). Almost half of the AF population was not dispensed on any OAC at discharge (48.8% in patients with history of AF and 46.3% in patients with new-onset AF). Conclusion In this real world study of patients with AF and recent valvular intervention, risk of new-onset AF after valvular intervention is high emphasizing need for frequent rhythm monitoring after intervention. A considerable undertreatment with OAC was observed despite being indicated for the majority of the patients. Warfarin was the OAC most frequently dispensed.

The feasibility evaluation of transapical saddle-shaped valved stent for transcatheter mitral valve implantation

Background: Transcatheter mitral valve implantation (TMVI) is a promising and minimally invasive treatment for high-risk mitral regurgitation (MR). The purpose of this study was to investigate the feasibility of a novel self-expanding valved stent for transcatheter mitral valve implantation via apical access. Methods: A novel self-expanding mitral valved stent system was designed and fabricated for the in vivo evaluation. It is consists of an atrial flange and a saddle-shaped ventricular body connected by two opposing anchors and two opposing extensions. During the valve deployment, each anchor is controlled by a recurrent string. TMVI was performed in ten pigs using the valve prosthesis through the apical access to verify technical feasibility. Echocardiography and ventricular angiography were used to assess hemodynamic data and valve function. The surviving pigs were sacrificed four weeks later to confirm stent deployment. Results: Ten animals underwent transapical mitral valve implantation with the novel mitral valved stent. Optimal valve deployment and accurate anatomical adjustment were obtained in nine animals. Implantation failed in one case, and the animal died one day later due to stent mismatch. After stent implantation, the hemodynamic parameter of other animals was stable and valve function was normal. The mean pressure across the mitral valve and left ventricular outflow tract (LVOT) were 2.98±0.91mmHg and 3.42±0.66 mmHg, respectively. The macroscopic evaluation confirmed the stable and secure positioning of the stents in the mitral valve. No obvious valve displacement, embolism, and paravalvular leakage were observed four weeks after valve implantation. Conclusions: This study proved that the novel mitral valved valve stent is technically feasible in animals. This device features opposing anchors, opposing recurrent strings, and saddle-like ventricular portions, providing structural design details for reducing TMVI complications. However, the long-term feasibility and durability of this valved stent need to be improved and verified.

Successful delayed endovascular correction of migration of transcatheter aortic valve prosthesis in left ventricle outflow tract: case report

<p>We report the successful endovascular correction of the migration of a transcatheter aortic valve prosthesis in the left ventricle outflow tract (LVOT). A 72-old man was underwent transcatheter aortic valve implantation (TAVI) at Almazov National Medical Research Centre for severe aortic stenosis. During the procedure, the self-expanding prosthesis dislocated 10–12 mm into the LVOT. The frame was optimised with the use of a balloon catheter, and aortic regurgitation I-II degree was achieved. However, on day 17 of hospitalisation, acute heart failure with episodes of asystole occurred as a result of severe paravalvular regurgitation; cardiopulmonary resuscitation was necessary. The prosthesis malpositioning was corrected by traction with endovascular snare devices. The patient was stable during the postprocedural period and discharged on day 31. Dislocation of self-expanding prostheses into the LVOT is a complication specific to TAVI that may quickly aggravate a patient’s condition; therefore, correction of valve malpositioning should be performed as soon as possible. The case reported here in an illustration of successful endovascular correction of dislocation performed with the snare traction technique. This bail-out approach can be used by interventional cardiologists in similar situations.</p><p>Received 27 May 2021. Revised 29 July 2021. Accepted 30 July 2021.</p><p><strong>Funding:</strong> The study did not have sponsorship.</p><p><strong>Conflict of interest: </strong>Authors declare no conflict of interest.</p><p><strong>Contribution of the authors<br /> </strong>Literature review: A.D. Gorovaya, D.D. Zubarev, A.A. Prokhorikhin<br /> Drafting the article: A.D. Gorovaya, V.S. Krasnov, A.A. Prokhorikhin<br /> Critical revision of the article: A.D. Gorovaya, M.A. Chernyavskiy, A.A. Prokhorikhin<br /> Surgical treatment: D.D. Zubarev, V.S. Krasnov, A.A. Prokhorikhin<br /> Final approval of the version to be published: A.D. Gorovaya, D.D. Zubarev, V.S. Krasnov, M.A. Chernyavskiy, A.A. Prokhorikhin</p>

Surgery after Failed Transcatheter Aortic Valve Implantation: Indications and Outcomes of a Concerning Condition

Objectives: The number of transcatheter aortic valve implantations (TAVI) has increased enormously in recent decades. Transcatheter valve prosthesis failure and the requirement of conventional surgical replacement are expected to attract more focus in the near future. Indeed, given the scarcity of research in this field, the next decade will likely represent the beginning of a period of meaningful exploration of the degenerative changes that occur with transcatheter valves. The current study represents—through a series of consecutive cases—one of the first analyses of the underlying causes of TAVI failure, i.e., degenerative, functional and infective, followed by surgical aortic valve replacement (SAVR) and postoperative outcome. Methods: Between October 2008 and March 2021, 2098 TAVI procedures, including 1423 with transfemoral, 309 with transapical, and 366 with transaortic access, were performed in our institution. Among these, 0.5% (number(n) = 11) required acute SAVR (n = 6) within 7 days (n = 3) or later (n = 2), and were included in the study. Results: Valve stent dislocation was the most common cause of replacement (83%). Causes of replacement within 7 days after TAVI were multifactorial. In the later course, endocarditis was the sole indication for SAVR after TAVI. TAVI with transapical or transaortal approach had a higher EuroSCORE II (10.9 (7.2–35.3) vs. 3.5 (1.8–7.8)). Their 30-day mortality after surgical conversion was higher (67% vs. 20%), when compared to those who underwent a transfemoral procedure. The longest documented survival beyond 30 days was 58 months. Conclusions: The causes of SAVR after TAVI failure are multifactorial, and include biological, physical and infectious factors. An acceptable midterm prognosis may be expected in patients with physical causes when dislocation of the catheter prosthesis is observed; in such cases, emergency conversion is required. Conversion due to infection, as in cases of endocarditis, had the worst outcome. Prognosis after conversion due to degeneration is still problematic, due to a lack of autopsies and the recent history of prosthetic implantations.

540 Progressive temporal reduction of complications after TAVI

Aims The TAVI registry represents a single-centre observational retrospective study that consecutively collected symptomatic patients with severe aortic stenosis between September 2009 and February 2021 at the Magna Graecia University (Catanzaro, Italy). Our aim was to evaluate the rate of complications which can occur after Transcatheter aortic valve replacement (TAVR) and its possible predictors. Methods We included a total of 346 consecutive patients, admitted to our institution between September 2009 and February 2021. Inclusion criteria were: severe aortic stenosis in high-risk patients unsuitable for surgery after cardiac team consent, valve anatomy adjusted according to device instructions for use, life expectancy&gt; 1 year. Clinical, echocardiographic and procedural data were collected and reported in an electronic database. Surgical risk was prospectively assessed using the European Cardiac Operational Risk Assessment System (EuroSCORE II, https://www.euros core.org/calc.html). The mean age of the population was 80.3 ± 5.4 years; 144 patients (41.6%) were male. The average EuroSCORE II was 6.3 ± 5.7. All reported P-values are two-sided and P-values &lt;0.05 were considered significant. STATA (StataCorp, USA) was used for data analysis. Results Out of the total population analysed, the number of patients who underwent a vascular complication was 23 or 6.6%. Female sex was an independent predictor of vascular complication (P 0.015) regardless of the presence of peripheral vascular disease (OR 3.73; 95% CI 1.20–11.5), while no correlation was found with BSA. The number of patients experiencing severe bleeding and/or need for transfusion was 85 or 24.6% of the total. Mean baseline haemoglobin values were 12.1 g/dL ± 1.7 with lower mean values reported during hospitalization of 9.2 g/dL ± 1.4 (P &lt;0.001), while predicted values at discharge were 9.8 g/dL ± 1.2. The pre and post procedural PR interval value was 171.1 ± 33.6 ms vs. 193.3 ± 35.7 ms (P &lt;0.001) (Figure 2). The pre-procedural QRS interval value was 95.0 ± 21.7, the post-procedural mean value was 115.4 ± 26.5 (P &lt;0.001). The number of patients with QRS&gt; 120 ms after the procedure was 92 (26.5%). Out of the total number of patients analysed, the number of subjects who required PM implantation was 77 patients, i.e. 22.3% of the total. Of these, 25 patients (32.4%), Evolut R 45 patients (58.6%) and Sapien 7 patients (9.0%) had received implants. The need for pacemaker implantation did not affect the average length of stay (P 0.5). Conclusions Since its advent, the transfemoral aortic valve prosthesis implant has experienced impressive and continuous growth, radically revolutionizing the treatment of symptomatic severe aortic stenosis. Furthermore, the clear improvement of the procedural safety and efficacy profiles, due on the one hand to the technological evolution of the devices, of the introduction and release systems and of the experience of the operators, has reduced the number of complications related to the implant and improved the management of the same.

Mitral valve-in-valve implantation during pregnancy

A 32-year-old, 11-week pregnant African woman with known rheumatic heart disease presented to the emergency department with worsening shortness of breath on exertion. She had undergone a double bioprosthetic valve replacement and left atrial appendage resection 8 years prior for severe mitral stenosis, moderate mitral regurgitation and moderate aortic regurgitation. A transo-oesophageal echocardiography at this presentation confirmed a morphologically calcified and stenosed mitral bioprosthesis, with moderate stenosis of her aortic bioprosthesis. Her multidisciplinary team, including cardiologists, cardiothoracic surgeons and obstetricians, came to a consensus decision to proceed with a transseptal transcatheter valve implantation within the mitral valve prosthesis (valve-in-valve implantation). Transthoracic echocardiography performed 2 months post procedure showed satisfactory mitral valve gradients and at 30 weeks’ gestation, she successfully delivered her fifth child. 2 years later, the valve in valve complex is still functioning well.

Concomittant use of Sapien 3 Transcatheter Valve for Severe MAC with Intuity Elite Rapid Deployment Valve for Aortic Stenosis

Background-Concomitant double valve pathology in the presence of severe MAC poses significant technical challenges when planning surgical intervention. With continued evolution of valve prosthesis, innovative techniques can be considered with the potential for additional therapeutic benefit. Case presentation-We present a novel technique of using a rapid deployment surgical aortic valve in combination with open surgical transcatheter mitral valve implantation (TMVI) for severe Mitral Annular Calcification (MAC). The Intuity Elite rapid deployment prosthesis (Edwards Lifesciences, Irvine, CA) was used concomitantly with the Sapien 3 (Edwards Lifesciences, Irvine, CA) transcatheter prosthesis trans-atrially on cardiopulmonary bypass in a patient with critical aortic stenosis and moderate-severe mixed mitral valve disease in the setting of severe MAC (off-label use). Conclusions-We demonstrate how both technologies can, not only be accommodated, but indeed complement each other achieving an excellent outcome in a high-risk patient.