应用MitraClip导管系统行经皮二尖瓣成形术的研究进展

<正>各种原因所致的二尖瓣关闭不全均在不同程度上使收缩期左心室内血流向左心房反流,从而增加左心室前负荷,导致心功能不全。随着心室的重构扩大,二尖瓣环也随之增大,二尖瓣反流量进一步增加,如此的恶性循环使得左心室功能不全加重,严重影响患者生活质量,可能导致心力衰竭     

Percutaneous mitral valve repair with the mitraclip® system

Objectives : The purpose of this study was to compare outcomes using standard clipping (SC) (one to two clips) or multiple clipping (MC) (more than two clips). Background : MitraClip^® implantation using MC has been proposed to treat severe mitral regurgitation (MR) in high‐risk patients. Methods and Results : A tailored strategy was used implanting as many clips as required to eliminate MR. A total of 85 consecutive patients [78 ± 6 years, 48 men (56.5%) ] with MR (grade 3+ or 4+) were included. EuroSCORE was 24 ± 12 (2.5–56.3) and STS‐score 12 ± 7 (1.2–31.2). SC was used in 61 (71.8%) and MC in 24 (28.2%) patients. Patients in MC group had larger mitral valve (MV) annuli (P = 0.025), MV orifice areas (MVOA) (P = 0.01), and MR degree (P = 0.005). Successful clip placement was achieved in 82 patients (96.5%). At discharge, no patient had grade 4+ MR. MR 3+ presented in 4 patients (7.0%) in the SC group and in 1 (4.5%) in the MC group (P = 0.72). There were 3 (3.5%) in‐hospital deaths. Follow up (211 ± 173 days, range 4–652) echocardiography confirmed similar MVOA (P = 0.83) and MV gradients (P = 0.54) in the both groups. At linear regression there was no independent correlation between clips number and postoperative MVOA/gradient. One‐year survival was 71.1% without difference between groups (P = 0.74). Conclusion: Although the hemodynamic and anatomical basis of MR may differ, every procedure should aim at eliminating MR. In some patients this goal can be achieved using MC with minimized risk of MV stenosis if preoperative anatomy/mechanism of MV regurgitation are adequately assessed. © 2012 Wiley Periodicals, Inc.     

经皮二尖瓣球囊扩张术治疗二尖瓣狭窄伴中度返流

目的　探讨经皮二尖瓣球囊扩张术 (PBMV)治疗二尖瓣狭窄 (MS)伴中度二尖瓣返流(MR)的近、远期疗效。方法　采用自制二尖瓣球囊导管治疗MS伴中度MR患者 6 2例 ,其中二尖瓣膜明显增厚、钙化者 7例 ,对左室最大前后径、二尖瓣口面积、左房平均压、二尖瓣跨瓣压差及心功能(NYHA分级 )等主要指标随访观察 12～ 36个月。结果　术后二尖瓣口面积明显增大 [(0 83± 0 18)cm2 比 (1 86± 0 2 4 )cm2 ,P <0 0 1],左房平均压 [(32± 8)mmHg比 (13± 8)mmHg ,P <0 0 1,1mmHg=0 133kPa]及二尖瓣跨瓣压差 [(18± 9)mmHg比 (5± 3)mmHg ,P <0 0 1]明显降低 ,心功能明显改善 [(2 81± 0 2 4 )级比 (1 4 6± 0 37)级 ,P <0 0 1],左室最大前后径无显著改变 [(4 5± 4 )mm比 (4 6± 4 )mm ,P >0 0 5 ]。对左室最大前后径、二尖瓣口面积及心功能等指标随访观察 12～ 36个月均无明显改变。结论　选择合适病例 ,严格把握球囊扩张终点 ,风湿性二尖瓣狭窄并中度返流患者PBMV的近、远期疗效显著。     

Percutaneous mitral valve repair: A new treatment for mitral regurgitation

Mitral valve disease affects more than 4 million people in the United States. The gold standard of treatment in these patients is surgical repair or replacement of the valve with a prosthesis. The MitraClip (Abbott Vascular, Menlo Park, CA) is a new technology, which offers an alternative to open surgical repair or replacement via a minimally invasive route. We present an evidence-based clinical update that provides an overview of this technology as it relates to managing patients with significant mitral regurgitation. This review article is particularly useful to noninterventional cardiologists and interventional cardiologists who will be managing patients with this novel technology in increased volumes over the next decade but who do not perform this procedure.     

经导管二尖瓣夹合术的临床结果介绍

目的 评估经导管二尖瓣夹合术（MitraClip）治疗中重度或重度二尖瓣反流患者的安全性和有效性.方法 2013年10月至2014年3月,使用MitraClip系统对10例有症状的中重度（1例）或重度（9例）二尖瓣反流患者行经导管二尖瓣修复术,分析10例患者手术即刻效果和30d随访结果.结果 10例患者的平均年龄（74±10.6）岁,功能性反流8例,器质性反流2例.所有手术均成功开展,顺利置入1个（5例）或2个（5例）MitraClip.手术即刻效果提示,5例患者二尖瓣反流下降3级,5例患者下降2级,未发生相关并发症.30d超声心动图随访提示,所有患者二尖瓣反流较术前降低≥2级,左心室射血分数（LVEF）由（40.2±11.9）％提高到（44.8±11.6）％,左心房内径和舒张期左心室内径分别由（6.4±0.5） cm和（6.1±0.8） cm缩小至（6.0±0.5） cm和（6.0±0.8） cm.所有患者的主观症状较术前有不同程度的改善,纽约心功能分级均较术前提高1级,生活质量评分和6 min步行试验分别由（0.7±0.2）和（279.0±123.0）m提高到（0.9±0.1）和（347.0±91.0）m.结论 本中心初步经验提示,经导管二尖瓣夹合术（MitraClip）可以带来超声心动图指标的改善和早期的临床获益,是安全有效的,但中远期效果有待于进一步随访.     

Mitral regurgitation following PASCAL mitral valve repair system: A single arm meta-analysis

Major consequences of untreated severe mitral regurgitation (MR) includes heart failure, ventricular remodeling and pulmonary hypertension leading to significant morbidity and mortality. MitraClip is the most widely used device for treatment of severe MR. To overcome some of the shortcomings of MitraClip, novel devices like PASCAL mitral valve repair system are developed. We performed a single arm meta-analysis for patients with severe mitral regurgitation (MR) undergoing PASCAL mitral valve repair system. The results showed that 93.8% patients had reduction in MR grade, with an average operative time of 88 min and an average increase of 86.33 m in 6-min walk test.     

MitraClip in CRT non-responders with severe mitral regurgitation

Background

Severe mitral regurgitation (MR) ≥ 3 + and left ventricular dyssynchrony in heart failure patients are markers of CRT non response. The MitraClip (MC) implantation is a therapy for MR ≥ 3 + in patients with high surgical risk of mitral valve reconstruction.

Methods and results

We investigated 42 patients with CRT and MR ≥ 3 + who received an MC device at our center. One and two year mortality rates were compared with the predicted mortality by Seattle Heart Failure Model (SHFM) and meta-analysis global group in chronic heart failure (MAGGIC), using the baseline characteristics of patients at the time of MC implantation.The median time interval between CRT and MC implantation was 20.1 (4.5–43.3) months. In 19 patients we observed a functional regurgitation with normal leaflets and in 23 patients a degenerative mechanism for mitral regurgitation. There was no change in mean QRS duration by biventricular pacing or MC implantation. The use of MC led to significant reductions in: median N-terminal pro-brain natriuretic peptide (NT-proBNP) level (pg/ml) from 3923 to 2636 (p = 0.02), tricuspid regurgitation pressure gradient (TRPG) from 43 to 35 mm Hg (p = 0.019) and in left ventricular end-diastolic volume (LVEDV) by MC (p = 0.008). At the 2 year follow-up interval the all-cause mortality was 25%.

Conclusion

MC implantation leads to an improvement of NT-proBNP level, TRPG and LVEDV in both functional and degenerative MR but does not influence QRS duration. Two year all-cause mortality was 25% and did not differ significantly from that predicted by SHFM and MAGGIC.     

Challenging MitraClip imaging case

MitraClip is a well-established method for treatment of mitral regurgitation. It is dedicated for patients, who cannot undergo surgery. But, we are facing some cases, which are out of standard indication criteria and they are technically challenging and uncommon, finally with very good results. We present a case report of a man, who suffered from severe mitral regurgitation after a previous surgical mitral valve repair.This was successfully solved with MitraClip implantation.     

Percutaneous edge‐to‐edge repair of severe mitral regurgitation using the MitraClip XTR versus NTR system

BackgroundTranscatheter mitral valve repair (TMVR) has shown to improve symptoms and functional capacity in patients with severe mitral valve regurgitation (MR). Novel device developments provide the technology to treat patients with complex anatomies and large coaptation gaps. Nevertheless, the question of superiority of one device remains unanswered. We aimed to compare the MitraClip XTR and MitraClip NTR system in a real world setting.HypothesisTMVR with the MitraClip XTR system is equally effective, but associated with a higher risk of leaflet injury.MethodsWe retrospectively analyzed peri‐procedural and mid‐term clinical and echocardiographic outcomes of 113 patients treated for severe MR between March 2018 and August 2019 at the University Hospital of Munich.ResultsPostprocedural MR reduction to ≤2+ was comparable in both groups (XTR: 96.1% vs. NTR: 97.6%, p = .38). There was a significant difference in a composite safety endpoint of periprocedural Major adverse cardiac and cerebrovascular events (MACCE) including leaflet injury between groups (XTR 14.6% vs. NTR 1.7%, 95% CI [2.7, 24.6], p = .012). After a median follow‐up of 8.5 (4.4, 14.0) months, durable reduction of MR was confirmed (XTR: in 91.9% vs. NTR: 96.8%, p = .31) and clinical and symptomatic improvement was comparable in both groups accordingly.ConclusionWhile efficacy was comparable in both treatment groups, patients treated with the MitraClip XTR systems showed more events of acute leaflet tear and single leaflet device attachment (SLDA). A detailed echocardiographic assessment should be done to identify risk candidates for acute leaflet injury.     

Percutaneous mitral valve annuloplasty for functional mitral regurgitation: acute results of the first patient treated with the Viacor permanent device and future perspectives

BackgroundThere is a need to develop less invasive techniques to manage moderate or severe functional mitral regurgitation in patients at high surgical risk.ObjectiveWe report the acute results of the first patient treated with the permanent Viacor percutaneous transvenous mitral annuloplasty (PTMA) device in North America, introduce the PTOLEMY-2 protocol, and briefly discuss the current status of transvenous mitral valve techniques.Case reportAfter several episodes of pulmonary edema, an 87-year-old woman was referred for hemodynamic evaluation. Angiography revealed normal coronary arteries and severe mitral regurgitation. Baseline echocardiography showed severe (4+) functional mitral regurgitation. The coronary sinus was cannulated with a 9.5-Fr introducer from a left subclavian approach. After distal positioning of a coronary wire, the 7-Fr PTMA Viacor catheter was advanced to the anterior interventricular vein. Two 130 g/cm rods were then inserted resulting in an acute and dramatic reduction in mitral regurgitation as assessed by continuous transoesophageal echocardiography and which was associated with a sudden rise in arterial blood pressure. The next day, transthoracic echocardiogram showed a significant reduction in effective regurgitant orifice area (EROA) from 41 to 10 mm². The patient was discharged home the day following the procedure without complication. In accordance with the PTOLEMY-2 protocol, she will undergo 3-D transthoracic echocardiograms, quality of life assessments, and 6-min walk tests at regular intervals for the next 5 years.ConclusionPTMA is a promising technique for the treatment of severe mitral regurgitation in selected patients. Further ongoing research will determine the predictors of success and long-term safety and performance of this technique.     

MitraClip for radiotherapy-related mitral valve regurgitation

ObjectiveOwing to mediastinal and cardiac damage burden, the surgical treatment of radiotherapy-related mitral regurgitation (MR) may be associated with high operative risk or might even contraindicated. We evaluated the feasibility and outcome of MitraClip therapy in patients with radiotherapy-related MR as an alternative to surgery.MethodsBased on Doppler Echocardiography, 15 of 33 screened patients underwent MitraClip implantation.ResultsFollowing MitraClip MR improved (residual MR ≤2+) without significant mitral valve stenosis (planimetric area 2.83 ± 0.8 cm², mean gradient 4.6 ± 1.8 mm Hg). All patients completed a 6-month follow-up, while 14 of 15 patients achieved a longer follow-up, ranging from 12 to 72 months (median 24 months, IQR 42 months). At 6-month follow-up we observed NYHA improvement in 13 patients with an increase of 6-min walking covered distance (from 260 ± 34 to 367 ± 70, p < 0.001), sustained moderate or less MR, mild mitral stenosis in 3 patients, and significant systolic Pulmonary Artery Pressure (PAPs) reduction (from 52.5 ± 14 to 42 ± 9, p < 0.01). Sustained clinical improvement and ≤2+ MR was observed in 13 of 14 patients who completed the 12-month follow-up. Two patients died of acute pneumonia (11 months and 60 months, respectively). One patient developed moderate MV stenosis (MVA 1.4 cm²) at last follow-up (48 months) without related clinical instability. Tricuspid regurgitation improved in 12 patients with further improvement at late follow-up in 2 of 3 patient with 3+.ConclusionMitraClip may be an effective treatment for RT-induced MR, although unexpected late stenosis may occur in the context of sustained reactive mitral apparatus damage following mediastinal radiation.     

Triple-orifice valve repair in severe Barlow disease with multiple-jet mitral regurgitation: Report of mid-term experience

Objectives

Barlow disease represents a surgical challenge for mitral valve repair (MR) in the presence of mitral insufficiency (MI) with multiple regurgitant jets. We hereby present our mid-term experience using a modified edge-to-edge technique to address this peculiar MI.

Methods

From March 2003 till December 2010, 25 consecutive patients (mean age 54 ± 7 years, 14 males) affected by severe Barlow disease with multiple regurgitant jets were submitted to MR. Preoperative transesophageal echo (TEE) in all the cases showed at least 2 regurgitant jets, involving one or both leaflets in more than one segment. In all the patients, a triple orifice valve (TOV) repair with annuloplasty was performed. Intra-operative TEE and postoperative transthoracic echocardiography (TTE) were carried out to evaluate results of the TOV repair.

Results

There was no in-hospital death and one late death (non-cardiac related). At intra-operative TEE, the three orifices showed a mean total valve area of 2.9 ± 0.1 cm² (range 2.5–3.3 cm²) with no residual regurgitation (2 cases of trivial MI) and no sign of valve stenosis (mean transvalvular gradient 4.6 ± 1.5 mm Hg). At follow up (mean 38 ± 22 months), TTE showed favourable MR and no recurrence of significant MI (6 cases of trivial and 1 of mild MI). Stress TTE was performed in 5 cases showing persistent effective valve function (2 cases of trivial MI at peak exercise). All the patients showed significant NYHA functional class improvement.

Conclusions

This report indicates that the TOV technique is effective in correcting complex Barlow mitral valves with multiple jets. Further studies are required to confirm long-term applicability and durability in more numerous clinical cases.     

MitraClip: Catheter-based treatment of mitral regurgitation

Mitral regurgitation (MR) is the second most prevalent heart valve disease requiring surgery. Despite the evidence of unfavourable prognosis, around half of patients with severe MR are not referred for surgery due to high per-operative risk. MitraClip (Abbott Vascular-Structural Heart, Menlo Park, California, United States) implantation is an emerging percutaneous technique with edge-to-edge MV repair inspired by the Alfieri surgery. Favourable safety profile together with improvement of functional status and decrease of MR severity in high-surgical-risk patients have been demonstrated in randomized clinical trials and “real-world” registries for both primary and secondary MR. Our own data confirmed its safety and efficacy comparing to minimally invasive MV surgery in treatment of functional MR in population with severe systolic heart failure.     

Superiority of mitral valve repair in surgery for degenerative mitral regurgitation

OBJECTIVES: We aimed to assess the influence of type of operation on outcomein degenerative mitral regurgitation. METHODS: We compared outcomes in 278 consecutive patients who underwentmitral valve repair (167 patients), replacement with subvalvularpreservation (22 patients) and without subvalvular preservation(89 patients) for degenerative mitral regurgitation. RESULTS: There was a trend towards lower mortality with repair and replacementwith subvalvular preservation compared to replacement withoutsubvalvular preservation. Thirty-day mortality was 1·2%vs 0·0% vs 4·7% (ns) respectively. Six-year survivalwas, respectively, 67·8±7·4% (P=0·088)vs 80·8±11·0% (P=0·25 vs 63·3±5·9%for all-cause death, 78·5±6·8% (P=0·063)vs 95·5±4·4% (P=0·092) vs 67·6±5·9%for all complication-related death and 80·5±6·9%(P=0·076) vs 100·0±0·0% (P=0·045)vs 72· ± 5·8% for complication-relateddeath due to myocardial failure. Multivariate analysis confirmedindependent beneficial effects from repair compared to replacementwithout subvalvular preservation on complication-related death(hazard ratio 0·42, P=0·010) and death from myocardialfailure (hazard ratio 0·40 P=0·014), and fromrepair compared to mechanical replacement on thromboembolism(hazard ratio 0·45, P=0·029) and anticoagulation-relatedhaemorrhage (hazard ratio 0·19, P=0·026). CONCLUSIONS: Mitral valve repair is superior to replacement. The greatestsurvival advantage is in reduced mortality from myocardial failure.Repair should be the operation of choice for degenerative mitralregurgitation.     

Mitral valve repair for severe mitral regurgitation: the way forward?

Severe primary mitral regurgitation (MR) has a poor outcome if left uncorrected. Successful mitral valve repair has the unique potential to restore normal life expectancy and is superior to valve replacement. Despite this, mitral repair is performed relatively infrequently and many patients with potentially reparable valves have a replacement instead, subjecting them to unnecessary risk. Surgery in asymptomatic patients is a particularly difficult issue with some units advocating surgery irrespective of symptoms, based purely on the severity of regurgitation. This strategy cannot be widely adopted with the current patchy provision of high-quality valve repair surgery. Misplaced enthusiasm for early operation runs the risk of a failed repair and the hazards of a mechanical prosthesis. To ensure optimal treatment for patients with MR, cardiologists must be aware of the indications for valve repair and ensure that patients with potentially reparable valves are referred to surgeons with proven expertise, even if this means a shift from established practice. Surgical units need to promote subspecialization and rigorously audit their outcomes. There are currently no agreed standards for best practice in mitral valve repair and this is an area where professional societies may wish to take a role.