经导管主动脉瓣置换的介入瓣膜的现状及展望

经导管主动脉瓣置换术（TAVR）经过最近几年快速发展已经取得巨大进步。迄今为止全球接受TAVR的患者数已近3万例,已成为无法耐受传统手术患者的标准备选治疗措施。从目前已临床应用的介入瓣膜到正在实验研究的新型介入瓣膜可以看出,未来介入瓣膜的发展目标是尺寸更小、长期有效、安全性高、并发症少、操作简单及定位精准。随着TAVR的推广,新型介入瓣的研发,操作者经验的积累,以及长期随访的开展,将给TAVR提供更科学的病例选择标准,减少介入手术的相关并发症,提高更安全有效的治疗效果。未来此项技术还会逐渐扩大适用人群的范围,成为代替传统的主动脉瓣置换术举足轻重的治疗措施。     

Long-term outlook for transcatheter aortic valve replacement

Transcatheter aortic valve replacement (TAVR) revolutionized the treatment of severe symptomatic aortic stenosis (AS). TAVR is increasingly offered for lower-risk patients. The role and place of TAVR in the future treatment of AS is not clear yet. In this review, we discuss the long-term outlook for TAVR, its challenges and its relationship to conventional surgical aortic valve replacement.     

Pacemaker dependency after transcatheter aortic valve replacement compared to surgical aortic valve replacement

Transcatheter aortic valve replacement (TAVR) is a standard treatment indicated for severe aortic stenosis in high-risk patients. The objective of this study was to evaluate the incidence of pacemaker dependency after permanent pacemaker implantation (PPI) following TAVR or surgical aortic valve replacement (SAVR) and the risk of mortality at a tertiary center in Korea.In this retrospective study conducted at a single tertiary center, clinical outcomes related to pacemaker dependency were evaluated for patients implanted with pacemakers after TAVR from January 2012 to November 2018 and post-SAVR from January 2005 to May 2015. Investigators reviewed patients’ electrocardiograms and baseline rhythms as well as conduction abnormalities. Pacemaker dependency was defined as a ventricular pacing rate > 90% with an intrinsic rate of <40 bpm during interrogation.Of 511 patients who underwent TAVR for severe AS, 37(7.3%) underwent PPI after a median duration of 6 (3–7) days, whereas pacemakers were implanted after a median interval of 13 (8–28) days post-SAVR in 10 of 663 patients (P < .001). Pacemaker dependency was observed in 36 (97.3%) patients during 7 days immediately post-TAVR and in 25 (64.9%) patients between 8 and 180 days post-TAVR. Pacemaker dependency occurred after 180 days in 17 (50%) patients with TAVR and in 4 (44.4%) patients with SAVR. Twelve (41.4%) patients were pacemaker-dependent after 365 days post-TAVR.Pacemaker dependency did not differ at 6 months after TAVR vs SAVR. In patients undergoing post-TAVR PPI, 58.6% were not pacemaker-dependent at 1 year after the TAVR procedure.     

Urgent transcatheter aortic valve replacement for severe acute aortic regurgitation following open mitral valve surgery

Transcatheter aortic valve replacement (TAVR) is not currently approved for pure native valve aortic incompetence, and is typically performed on a compassionate basis in selected patients who are at high risk for conventional surgery. We describe the first use of TAVR to treat iatrogenic severe acute pure aortic incompetence following mitral valve surgery. A 71‐year‐old gentleman developed life‐threatening acute aortic regurgitation (AR) within hours of a very challenging fifth open heart mitral valve replacement. Careful inspection of echocardiographic and computed tomographic imaging identified the cause as a disrupted left coronary cusp at the commissure caused by the surgical mitral annular reconstruction. Medical management with afterload reduction failed with recurrent pulmonary edema, and a sixth open heart surgery was deemed prohibitively high risk. The lack of aortic annular calcium onto which anchors a transcatheter valve was a concern for TAVR. However, we postulated that the struts of the mitral valve bioprosthesis would offer some support to the TAVR valve. We opted for a self‐expanding system because of concerns about potential unfavorable interaction between the balloon onto which balloon‐expandable bioprosthesis is mounted and the struts of the mitral bioprosthesis, and because the Evolut R system has additional anchoring points at the crown which might enhance transcatheter valve stability in the non‐calcified annulus, compared with the Edwards Sapien system. Transfemoral TAVR, performed with a Medtronic Evolut R 34 mm system under general anesthesia and using moderately rapid ventricular pacing, was successful with minimal residual AR. On follow‐up 1 month later the patient was asymptomatic, and the aortic and mitral bioprostheses were functioning normally on echocardiogram.     

Transaortic transcatheter aortic valve implantation within a previous bioprosthetic aortic valve replacement

This report documents the first reported case of transaortic transcatheter aortic valve implantation (TAVI) using the CoreValve ReValving system (Medtronic CoreValve System, Luxembourg), within a previous bioprosthetic aortic valve replacement. TAVI has become a recognized percutaneous treatment for patients with severe native or bioprosthetic aortic valve stenosis. However, as the number of patients screened for TAVI increases, a number of patients are found with absolutely no option for peripheral arterial access, either from the femoral or subclavian routes. Transaortic CoreValve placement offers an alternate minimally invasive hybrid surgical/interventional technique when peripheral access is not possible. A CoreValve prosthesis was implanted via the transaortic route in an 81‐year‐old woman with severe bioprosthetic aortic valve stenosis (21 mm Mitroflow pericardial valve, peak instantaneous gradient of 99 mmHg, effective valve orifice area (EOA) of 0.3 cm², as ilio‐femoral and left subclavian angiography revealed small calibre vessels (<6 mm). Access was achieved via a mini thoracotomy via the left anterior second intercostal space. The procedure went without complication. Post procedure the patient was transferred directly to the Cardiac Care Unit for recuperation. Post procedure echocardiography showed that the TAVI was well positioned with no para‐valvular leak and a reduction in peak instantaneous gradient to 30 mmHg and an increase in EOA to 1.5 cm². She was discharged on the third post‐procedural day in sinus rhythm with a narrow QRS complex. CoreValve implantation within previous surgical bioprosthesis is now an established treatment. The transaortic approach to transcatheter implantation is a promising recent development, when due to anatomical reasons, transfemoral or subclavian TAVI is not feasible. © 2011 Wiley‐Liss, Inc.     

The impact of mitral stenosis on outcomes of aortic valve stenosis patient undergoing surgical aortic valve replacement or transcatheter aortic valve replacement

Background

The concomitant presence of mitral stenosis (MS) in the setting of symptomatic aortic stenosis represent a clinical challenge. Little is known regarding the outcome of mitral stenosis (MS) patients undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Therefore, we sought to study the outcome of MS patients undergoing aortic valve replacement (AVR).

Method

Using weighted data from the National Inpatient Sample (NIS) database between 2011 and 2014, we identified patients who were diagnosed with MS. Patients who had undergone TAVR as a primary procedure were identified and compared to patients who had SAVR. Univariate and multivariate logistic regression analysis were performed for the outcomes of in‐hospital mortality, length of stay (LOS), blood transfusion, postprocedural hemorrhage, vascular, cardiac and respiratory complications, permanent pacemaker placement (PPM), postprocedural stroke, acute kidney injury (AKI), and discharge to an outside facility.

Results

A total of 4524 patients were diagnosed with MS, of which 552 (12.2%) had TAVR and 3972 (87.8%) had SAVR. TAVR patients were older (79.9 vs 70.0) with more females (67.4% vs 60.0%) and African American patients (7.7% vs 7.1%) (P < 0.001). In addition, the TAVR group had more comorbidities compared to SAVR in term of coronary artery disease (CAD), congestive heart failure (CHF), chronic lung disease, hypertension (HTN), chronic kidney disease (CKD), and peripheral vascular disease (PVD) (P < 0.001 for all). Using Multivariate logistic regression, and after adjusting for potential risk factors, TAVR patients had lower in‐hospital mortality (7.9% vs 8.1% adjusted Odds Ratio [aOR], 0.615; 95% confidence interval [CI], 0.392–0.964, P = 0.034), shorter LOS. Also, TAVR patients had lower rates of cardiac and respiratory complications, PPM, AKI, and discharge to an outside facility compared with the SAVR group.

Conclusion

In patients with severe aortic stenosis and concomitant mitral stenosis, TAVR is a safe and attractive option for patients undergoing AVR with less complications compared with SAVR.

     

Carotid artery access for transcatheter aortic valve replacement

We report three patients who had successful transcatheter aortic valve replacement (TAVR) via carotid artery access. None were candidates for thoracotomy (including minimal access incisions) and had no other vascular access sites that would accommodate the transcatheter valve sheath. Antegrade carotid perfusion and retrograde insertion of the delivery sheath maintained cerebral blood flow without sequelae. Carotid access for TAVR is an option for unusual patients without other access. © 2012 Wiley Periodicals, Inc.     

Echocardiographic follow‐up after transcatheter aortic valve replacement

The use of transcatheter aortic valve replacement (TAVR) for high‐risk patients with aortic stenosis has rapidly increased during the past years. Accordingly, more and more patients are referred for a follow‐up echocardiographic study after TAVR. However, the echocardiographic evaluation of patients who underwent TAVR places specific demands on echocardiographers. Furthermore, TAVR may be associated with new types of complications, which are frequently unrecognized or underestimated due to lack of familiarity with the normal and pathological appearance of TAVR. Therefore, this review summarizes the echocardiographic parameters describing the structural and functional status of bioprostheses used in TAVR, procedures taking into account their peculiar hemodynamics. We also describe the strengths and the limitations of echocardiography and of other imaging modalities in detecting long‐term complications of TAVR (eg, infective endocarditis, thrombosis). The aim of this review was to serve as a guide for a structured echocardiographic follow‐up of TAVR patients, as well as for the echocardiographic diagnosis of the procedure‐associated complications.     

经股动脉经导管主动脉瓣置换术治疗单纯主动脉瓣关闭不全

【摘要】 目的 探讨Venus-A支架瓣膜行经股动脉经导管主动脉瓣置换术治疗单纯主动脉瓣关闭不全患者的可行性。方法 回顾性调阅2018年12月至2019年12月在阜外医院接受经股动脉经导管主动脉瓣置换术的15例单纯主动脉瓣关闭不全患者的床资料。其中男性12例, 女性3例,年龄68—83岁,平均年龄(74.65±5.52)岁。患者术前均有左心功能不全症状,且术前心脏超声诊断均为单纯主动脉瓣重度返流。结果 患者行经股动脉经导管主动脉瓣置换术。所有病例成功植入Venus-A支架瓣膜。全组病例无死亡。出院前对患者进行临床评估和超声心动图检查。术中行瓣中瓣治疗3例,少量瓣周返流2例。其余病人均无明显瓣周返流,并且顺利出院。结论 经股动脉经导管主动脉瓣置换术治疗单纯主动脉瓣关闭不全患者是可行的,术后早期结果满意。     

Salvaging lowermost deployment of an acurate device during transcatheter aortic valve replacement with balloon and lasso pull techniques

Transcatheter aortic valve replacement (TAVR), also known as transcatheter aortic valve implantation (TAVI), is being used with increasing frequency in patients with severe aortic stenosis at high or prohibitive surgical risk. A number of devices are becoming available for TAVR, and competence in using them is mandatory to maximize the safety and efficacy of TAVR, while individualizing device selection in keeping with patient features. The ACURATE TF is a novel promising device for transfemoral TAVR. However, its peculiar features may require additional maneuvers in case of complications. We hereby report the case of a patient undergoing transfemoral TAVR with the ACURATE TF device, in whom lowermost deployment was complicated by massive aortic regurgitation. With two separate remedial actions, the balloon pull and lasso techniques, we were able to pull back the device and significantly reduce post‐TAVR aortic regurgitation. Awareness of this complication and the possible use of these two techniques may increase the safety and efficacy of TAVR with this and other new devices. © 2015 Wiley Periodicals, Inc.     

The noninferiority of transcatheter aortic valve implantation compared to surgical aortic valve replacement for severe aortic disease: Evidence based on 16 randomized controlled trials

Background:Currently, transcatheter aortic valve implantation (TAVI) as an effective and convenient intervention has been adopted extensively for patients with severe aortic disease. However, the efficacy and safety of TAVI have not yet been well evaluated and its noninferiority compared with traditional surgical aortic valve replacement (sAVR) still lack sufficient evidence. This meta-analysis was designed to comprehensively compare the noninferiority of TAVI with sAVR for patients with severe aortic disease.Methods:A systematic search of PubMed, Embase, Cochrane Library, and Web of Science up to October 1, 2020 was conducted for relevant studies that comparing TAVI and sAVR in the treatment of severe aortic disease. The primary outcomes were early, midterm and long term mortality. The secondary outcomes included early complications and other late outcomes. Two reviewers assessed trial quality and extracted the data independently. All statistical analyzes were performed using the standard statistical procedures provided in Review Manager 5.2.Results:A total of 16 studies including 14394 patients were identified. There was no difference in 30-day, 1-year, 2-year, and 5-year all-cause or cardiovascular mortality as well as stroke between TAVI and sAVR. Regarding to the 30-day outcomes, compared with sAVR, TAVI experienced a significantly lower incidence of myocardial infarction (risk ratio [RR] 0.62; 95% confidence interval [CI] 0.40–0.97; 5441 pts), cardiogenic shock (RR 0.34; 95% CI 0.19–0.59; 1936 pts), acute kidney injury (AKI) > stage 2 (RR 0.37; 95% CI 0.25–0.54; 5371 pts), and new-onset atrial fibrillation (NOAF) (RR 0.29; 95% CI 0.24–0.35; 5371 pts) respectively, but higher incidence of permanent pacemaker implantation (RR 3.16; 95% CI 1.61–6.21; 5441 pts) and major vascular complications (RR 2.22; 95% CI 1.14–4.32; 5371 pts). Regarding to the 1- and 2-year outcomes, compared with sAVR, TAVI experienced a significantly lower incidence of NOAF, but higher incidence of neurological events, transient ischemic attacks (TIA), permanent pacemaker and major vascular complications respectively. Regarding to the 5-year outcomes, compared with sAVR, TAVI experienced a significantly lower incidence of NOAF, but higher incidence of TIA and reintervention respectively.Conclusions:Our analysis shows that TAVI was equal to sAVR in early, midterm and long term mortality for patients with severe aortic disease. In addition, TAVI may be favorable in reducing the incidence of both early, midterm and long term NOAF. However, pooled results showed superiority of sAVR in reducing permanent pacemaker implantation, neurological events, TIA, major vascular complications and reintervention.     

Procedural and clinical outcomes of the valve‐in‐valve technique for severe aortic insufficiency after balloon‐expandable transcatheter aortic valve replacement

Objective : To describe the clinical and procedural outcomes of patients treated with the valve‐in‐valve technique for severe aortic insufficiency (AI) after balloon‐expandable transcatheter aortic valve replacement (TAVR). Background : Severe AI immediately after valve implantation is a notable complication of TAVR. It can be treated with a valve‐in‐valve technique which involves deploying a second valve within the first one to crush the leaflets of the first implant leaving a new functional valve. Methods : We analyzed data on 142 consecutive patients at our institution undergoing TAVR with the Sapien valve between November of 2007 and April of 2011. Etiologies of acute AI, procedural and intermediate term clinical outcomes were reported for those in whom a valve‐in‐valve procedure was necessary. Post‐hoc analysis of these cases with C‐THV imaging (Paieon Medical Ltd.) was performed to elucidate the mechanism for successful AI treatment. Results : A total of 5 of 142 (3.5%) patients were treated with the valve‐in‐valve technique. Etiologies of the aortic valve insufficiency included bioprosthesis malposition (n = 3), valve dysfunction (n = 1), and valve undersizing (n = 1). With placement of the second valve, the first valve dimensions increased to approach the nominal valve size while the second valve size remained less than nominal. Conclusions : The valve‐in‐valve technique is an appropriate bailout measure for patients with acute valvular AI after balloon‐expandable TAVR. © 2012 Wiley Periodicals Inc.     

Transfemoral transcatheter aortic valve implantation after aortic valve repair with HAART 300 device

We report the first successful case, to our knowledge, of CoreValve Evolut R (Medtronic, Minneapolis, MN) implantation into a failed HAART 300 aortic annuloplasty device (BioStable Science & Engineering, TX). An 81‐year‐old man presented with severe symptomatic aortic regurgitation secondary to failure of the 21 mm HAART 300 device, which had been implanted 45 days previously. Transthoracic echocardiography (TTE) revealed grade 3 aortic regurgitation with central jet, without aortic valve stenosis. Because of the high risk for redo surgery, the heart team proceeded with femoral transcatheter aortic valve implantation. The 26 mm CoreValve Evolut R was deployed into the 21 mm HAART 300 device without difficulty or complications. There were no intraoperative or postoperative complications. The patient was discharged after 5 days. TTE showed a mean aortic valve gradient of 18 mmHg, with minimal paravalvular leak. Our experience suggests that CoreValve Evolut R implantation may be an attractive option in patients with failed HAART 300 aortic annuloplasty.     

A very rare vascular complication of the Edwards expandable eSheath during transcatheter aortic valve replacement

Transcatheter aortic valve replacement (TAVR) has revolutionized the management of severe symptomatic aortic valve stenosis. TAVR is now indicated as an alternative to surgical replacement in a wide risk profile ranging from high to low surgical risk. Although vascular complications have decreased in frequency over time, with the introduction of lower profile delivery systems and sheaths, they remain one of the most frequently encountered and serious complications of TAVR. Patient-specific predisposing factors have been well characterized. However, much less is known about device-specific complications. Awareness of the possible device-related complications may lead to earlier identification, prompt management, and better outcomes. We report a previously unreported complication of the Edwards expandable eSheath that lead to avulsion of the external iliac artery following successful TAVR with a 29-mm Edwards Sapien 3 transcatheter heart valve. Bleeding was promptly controlled with an occlusion balloon and emergency surgical repair was required with a favorable outcome.