1. 016 门诊 CLINIC
东闻视野·TAVR探索 The TAVR
深入PARTNER研究，探讨更优化的TAVR技术
Probe into PARTNER and Find out Refining
TAVR Therapies
2. 017门诊 CLINIC
Physicians’Viewpoints 专家观点·东闻视野
TAVR——Transcatheter Aortic Valve Replacement
is no doubt a controversial topic in current cardiovascular
interventional world, since it has provided an important micro-
invasive alternative but also a tremendous fatal risk profile both
procedural and post-procedural to treat this high-risk patients with
advanced age for aortic stenosis.
The crucial investigators on TAVR globally including Gregg
W. Stone from Columbia University Medical Center, New York
and Junbo Ge from Fudan University Zhongshan Hospital,
Shanghai convey their insights concerning the trends of refining
TAVR therapy Esp. on solutions to frequent MLBCs profile
associated with its invariably increased mortality in PARTNER 1
followed by PARTNER Registry extension comprising regimens
and devices on March Clinic •Cardiology.
经皮主动脉瓣置换术（TAVR）无疑已是全球心血管介
入领域今日最火热的争议点之一。TAVR是一个了不起的技
术——人工瓣膜经皮置换为主动脉狭窄的高危老年人群提供
了一种微创的介入治疗手段；然而，术中及术后极高的事件
和死亡风险又使其在真实世界能够产生的终点获益及生存年
数获益遭受争议。
因 此 T A V R 需 要 循 证 ， 以 在 临 床 中 获 得 验 证 并 突
破；也因此针对TAVR的最新研究报道从未止休。最近
的PARTNER 1 Trial以及在此基础上扩展的PARTNER
Registry显示，PARTNER 1A及PARTNER 1B患者群体
TAVR术后30天至1年期间MLBCs（主要远期出血并发症）
极为高发，并随之引起死亡率的上升。三月刊《门诊·心血
管领域》杂志聚集海内外TAVR临床的知名专家，包括纽约
哥伦比亚大学医学中心的Gregg W. Stone教授和复旦大学附
属中山医院的葛均波院士共同探讨更精细化TAVR技术的发
展趋势，尤其他们对于术中及术后有效控制MLBCs更优化的
药物及技术策略的见解。
3. 018 门诊 CLINIC
东闻视野·TAVR探索 The TAVR
Incidence, Predictors, and Prognostic Impact of Late Bleeding
Complications After Transcatheter Aortic Valve Replacement
Philippe Généreux, MD, David J. Cohen, MD, MSC, Michael Mack, MD, Josep Rodes-Cabau, MD, Mayank Yadav, MD, Ke Xu, PHD, Rupa
Parvataneni, MS, Rebecca Hahn, MD, Susheel K. Kodali, MD, John G. Webb, MD, Martin B. Leon, MD
Disclosures
J Am Coll Cardiol. 2014;64(24):2605-2615.
Abstract
Background The incidence and prognostic impact of late
bleeding complications after transcatheter aortic valve
replacement (TAVR) are unknown
Objectives The aim of this study was to identify the incidence,
predictors, and prognostic impact of major late bleeding
complications (MLBCs) (≥30 days) after TAVR.
Methods Clinical and echocardiographic outcomes of patients
who underwent TAVR within the randomized cohorts and
continued access registries in the PARTNER (Placement of
Aortic Transcatheter Valves) trial were analyzed after stratifying
by the occurrence of MLBCs. Predictors of MLBCs and their
association with 30-day to 1-year mortality were assessed.
Results Among 2,401 patients who underwent TAVR and
survived to 30 days, MLBCs occurred in 142 (5.9%) at a median
time of 132 days (interquartile range: 71 to 230 days) after the
index procedure. Gastrointestinal complications (n = 58 [40.8%]),
neurological complications (n = 22 [15.5%]), and traumatic falls
(n = 11 [7.8%]) were identified as the most frequent types of
MLBCs. Independent predictors of MLBCs were the presence of
low hemoglobin at baseline, atrial fibrillation or flutter at baseline
or 30 days, the presence of moderate or severe paravalvular leak
at 30 days, and greater left ventricular mass at 30 days. MLBCs
were identified as a strong independent predictor of mortality
between 30 days and 1 year (adjusted hazard ratio: 3.91; 95%
confidence interval: 2.67 to 5.71; p < 0.001).
Conclusions MLBCs after TAVR were frequent and associated
with increased mortality. Better individualized and risk-adjusted
antithrombotic therapy after TAVR is urgently needed in this
high-risk population.
Figure 1.
Kaplan-Meier Curves Showing
Cumulative Adverse Event Rates
Through 1 Year Between Patients
With Late Bleeding Compared With
No Late Bleeding Complications
Comparison of cumulative adverse
event rates through 1 year in patients
with late bleeding compared with patients
with no late bleeding. (A) All-cause
mortality, (B) cardiac mortality, (C)
rehospitalization, and (D) major stroke. CI
= confidence interval; HR = hazard ratio.
4. 019门诊 CLINIC
Physicians’Viewpoints 专家观点·东闻视野
TAVR Perspective
Dr. Gregg W. Stone: All medical procedures have risks
and complications. For patients with severe aortic stenosis the
aortic valve has to be replaced. TAVR is a safer alternative than
surgical aortic valve replacement, despite bleeding complications
and should be used in patients at high risk for surgery.
Dr. Philippe Généreux: Above all things, the PARTNER
trial whether the PARTNER trial 1B, 1A, or all the Continued
Access studies show that TAVR is a really viable option, for
patients that are inoperable or not suitable for surgery. The goal
of this paper on late bleeding events was to investigate what were
the incidence, the impact, and the predictor of late bleeding after
TAVR, meaning the bleeding that occurred after 30 days.
Why have we looked into the late bleeding? The early experience
showed very high rate of peri-procedural bleeding (within 30
days) after TAVR mainly because of vascular complications.
On the other hand, the surgical AVR also showed high rates of
bleeding events after surgery, actually 2 to 3 times higher than
TAVR.
Currently, peri-procedural bleeding and vascular complications
have been significantly reduced with improved devices profile.
With more experienced operator and with further improvement in
device size and profile, these complications (vascular and bleeding
within 30 days) would be almost eliminated.
What was not known before was what was the bleeding rate after
30 days, especially among patient who survived. We saw that
these late bleeding, between 30 days and 1 year, were frequent,
occurring in about 6% of the patients. These findings highlight the
need to better improve the treatment of patient after the procedure,
mainly by individualizing the anti-thrombotic and antiplatelet
therapy after TAVR among this population of patients that are at
high risk of bleeding. One thing to keep in mind is that despite
Clinic: The result of PARTNER trial shows that, Major Late Bleeding Complications
(MLBCs) between 30 days and 1 year after TAVR were frequent and associated
with increased mortality. Hence，do you think TAVR is a perspective technique and
qualified to be spread in real world in future?
the high rate of late bleeding among TAVR patients, the risk of
bleeding among SAVR patients after 30 days is expected to be
even higher, mainly because of the highest risk of new onset atrial
fibrillation, requiring aggressive anticoagulation.
I truly believe that this work will not preclude or slow-down any
widespread of the TAVR procedure as the preferred option of
treatment for inoperable or high risk patients suffering of severe
aortic stenosis. On the contrary, we have identified area for further
improvement to improve patient outcome, mainly by reducing
bleeding events after TAVR. Several randomized trials are
currently underway and may bring meaningful insight relatively to
this problem.
Dr. Junbo Ge: Despite MLBCs after TAVR were frequent in
PARTNER 1, it is not considered the reason that would frustrate
TAVR from being spread in the overall world as is an effective
therapy. PARTNER 1B showed that TAVR leaded to significant
mortality reduction, while the vascular complications and stroke
were remained high occurrence. And actually, for the observed
in trial were patients with advanced age who have multiple
comorbidities at baseline per se, in whole the bleeding risk was
originally high from their recruitment. Hence, the MALCs shown
were not invariably associated with their TAVR therapies.
In analysis in PARTNER B, the researchers found that the
MLBCs (between 30 days and 1 year) after TAVR compared
with non-invasive arm were not significantly different (5.5% vs.
7.3%, P > 0.05). Furthermore, the MLBCs in TAVR group versus
Surgical AVR were not statistically different either (5.4% vs. 6.2%,
P > 0.05). That said, the majority of MLBCs in PARTNER were
more related to the patients’ bleeding susceptibility instead of
deriving from TAVR interventional procedure.
Dr. Yan Wang: According to the clinical evidences of
5. 020 门诊 CLINIC
东闻视野·TAVR探索 The TAVR
treatment of severe aortic stenosis so far, TAVR is no doubt a
perspective technology. During the past decade or more when
TAVR is getting developed, there have been more than 100,000
patients undergoing the procedure. Retrospective study shows
that among the symptomatic severe aortic stenosis patients,
only 35.2% of them received traditional SAVR. Because of the
high surgical risk, there were 5.6% patients taking transcatheter
aortic valve implantation and 56.4% of them taking medication[1]
.
And among those who did not undergo SAVR, Cardiovascular
Event Free Survival rate within 2 years was only 20%[2]
. Due to
th poor long-term curative effect of aortic valvuloplasty, it has
been applied lesser and lesser in clinic practice, and it is now
only used as a transition treatment approach to alleviate the pre-
proceduralsymptoms[3]
of the patients.
Currently, relevant clinical evidences show that the clinical
effect of TAVR is better than medication and non-inferior to
SAVR[4]
. PIVOTAL study released in 2014 confirmed that the
survival rate one year after TAVR in patients who experienced
TAVR was even higher than those undergoing SAVR[5]
. Several
5-year (or more) follow-up results showed that the function
declining of TAVR valve implanted was also in the acceptable
range[6, 7]
. For example, in a trial announced by Prof. Vahanian
A (Bichat Hospital, Paris, France) which recruited 123 patients
who underwent TAVR procedure, around 1/3 patients were still
survival in the sixth year of follow up. And the quality of life and
heart function were also benefited[8]
.
And we believe that due to the development of techniques such as
Valve-in-Valve, those with severe aortic stenosis at intermediate
risk who cannot undergo SAVR are also potentially adapted to
TAVR therapy[9]
.
Gregg W. Stone
MD, FACC, FSCAI is the Professor of Medicine at the Columbia University Medical
Center, Director of Cardiovascular Research and Education at the Center for
Interventional Vascular Therapy at New York-Presbyterian Hospital, and Co-
Director of Medical Research and Education at the Cardiovascular Research
Foundation in New York, NY. Dr. Stone has served as the national or international
principal investigator for more than 80 national and international multicenter
randomized trials, has authored more than 2000 book chapters, manuscripts and
abstracts published in the peer-reviewed literature, and has delivered thousands
of invited lectures around the world. Dr. Stone, along with Dr. Martin B. Leon, is the
director of Transcatheter Cardiovascular Therapeutics (TCT), the world's largest
symposium devoted to interventional cardiology and vascular medicine, directs
the annual National Interventional Cardiology Fellow's Course, and co-directs
multiple other annual courses.
Dr. Stone completed medical school at Johns Hopkins University Medical Center,
in Baltimore, MD, and his internship and residency at the New York Hospital-
Cornell Medical Center in New York City. He completed his general cardiology
fellowship at Cedars-Sinai Medical Center in Los Angeles, CA, under Dr. Jeremy
Swan, and subsequently a dedicated fellowship in advanced coronary angioplasty
along with Dr. Geoffrey O. Hartzler in Kansas City, MO.
Philippe Généreux
graduated from Montreal University Medical School. He completed his training
in internal medicine and cardiology at Sherbrooke University, with one year of
interventional cardiology fellowship at Sacré-Coeur Hospital, Montreal University,
and a master degree in biostatistics from Montreal University. He completed his
training with a three year fellowship at Columbia University Medical Center and
the Cardiovascular Research Foundation. He is working as an Interventional
Cardiologist at Sacré-Coeur Hospital, Montreal University, and Columbia
University Medical Center/CRF. Philippe is the Director of the angiographic Core
Laboratory at the CRF. During the TCT 2012, he received the "Young Investigator
Awards" for his clinical and research activities. He currently has more than 125
manuscripts and 150 abstracts, published or in-press.
7. 022 门诊 CLINIC
东闻视野·TAVR探索 The TAVR
Major Late Bleeding Complications
Clinic: Is there any means to be developed to reduce the MLBCs caused mortality?
Dr. Gregg W. Stone: In the future bleeding complications
after TAVR will decrease as the size and profile of the TAVR
devices is reduced, which will decrease vascular complications.
Dr. Philippe Généreux: During the procedure, we are
already seeing a dramatic reduction of bleeding events mainly
because of the better profile of the device. Also, increase operator
experience and maturity of the Heart Team have resulted in a
significant reduction of such complications.
To insure improve outcomes after 30 days, we have to make
sure that these patients would get optimal antiplatelet or anti-
coagulation therapy to reduce stroke and other thrombotic
events, but at the same time, safer therapy to reduce bleeding.
Avoiding triple therapy or to make sure that these patients have
adequate gastro-protection are some examples of good practices
to prevent bleeding events.
Dr. Junbo Ge: The predictive factors for bleeding risk in
PARTNER trial are Atrial Fibrillation (AF), moderate-severe
paravalvular leak (PVL), and greater left ventricular mass index
(LVMI). Patient with AF face increased bleeding risk due to
their indispensable antithrombotic medication; moderate-severe
paravalvular leak triggers high-flow turbulence that promotes
bleeding events.
As far as reducing MALCs and associated mortality is
concerned, on one hand, we should define safer antithrombotic
regimens, prescribe more NOACs, and an application of LAAC
is also an optimal alternative on eligible population. And on
the other hand, new designed TAVR valve is commissioned to
accomplish PVLs decreasing.
Dr. Yan Wang: By now, the studies mainly regarding
MLBCs are remained quite few. Early Bleeding Complications
after TAVR are about 30% to 70%, while Late Bleeding
Complications reach 14.7% to 28.6%. Nearly 60% late bleeding
is associated with dual antiplatelet therapy, and more than 80%
late bleeding occurs within 6 months after TAVR[10]
.
ESC Guidelines[11,12]
currently recommend dual antiplatelet
therapy (ASA+PLAVIX) for Post-TAVR patient lasting 3~6
months. Although there is the retrospective study in single
center to show that dual antiplatelet therapy is not superior to
Aspirin[13,14]
, it is still a lack of convincing evidence based on
randomized controlled clinical tials.
Furthermore, it is a fact that patient with severe aortic stenosis
combined with coronary disease or atrial fibrillation is majority
among all TAVR population. Those patients have an increased
occurrence of MLBCs [15]
risk due to a longer duration of DAPT
and most probable additional anticoagulation therapy. The
previous studies indicate that the risk factors associated with
post-procedural bleeding can be illustrated as advanced age,
anemia tendency, renal failure and low Body Mass Index[10]
,
based on which the author makes the recommendations to reduce
the bleeding risk as below:
A. Enhance Pre-procedural Assessment: We are recommended
not only assess the severity and surgical risk of patient with valve
disease but also their bleeding risk under antiplatelet (or plus
anti-coagulation) therapy via predictive tools that we have now.
B. Make Individualized Procedural Strategies: To select
appropriate procedural access, sizes of devices is so crucial
an aspect that avails to decrease bleeding risk at the maximal
extent. For procedural or post-procedural complications are
often associated with procedural access, and the major vascular
complications once happened subsequently will invariably impair
patient’s short/long term survival.
C. Utilize bleeding risk score specialized in TAVR: Use those
tools to guide antiplatelet or anti-coagulation therapies after
procedure. To patient at high risk of bleeding, mono-antiplatelet
agent/Vitamin K antagonists are the options to reduce MLBCs.
While there are not yet any clinical evidences to support that
New Oral Anticoagulants (NOACs) are used as secondary
prevention of post-TAVR thrombosis.
9. 024 门诊 CLINIC
东闻视野·TAVR探索 The TAVR
Antithrombotic Therapies
Clinic: The authors concluded PARTNER trial at appealing that better individualized and risk adjusted
antithrombotic therapy after TAVR is urgently needed in this high-risk population. In your viewpoint,
what is the antithrombotic therapy we urgently need that gains maximally for this post-TAVR subset?
Dr. Gregg W. Stone: Antiplatelet and antithrombotic
agents increase bleeding. Currently we don’t know whether after
TAVR patients should be on aspirin, aspirin and clopidogrel,
clopidogrel alone, and for how long. Warfarin further increases
bleeding but is important in patients with atrial fibrillation.
Further studies are required to learn in whom combinations of
these agents is beneficial and reasonably safe.
Dr. Philippe Généreux: The first thing we should do is
to categorize patients into different category. Every single patient
is unique, and a single regimen will not be appropriate for all of
them. Four groups of patients may exist.
The first one is a severe aortic stenosis patient with no coronary
disease and no atrial fibrillation. This patient is very low risk
for stroke as well as for bleeding, and probably a less intense
antiplatelet therapy will be appropriate.
The second subset of patient is the patient with severe aortic
stenosis and prior PCI, treated with recent (within 12 months)
stent implanation. Of course, these patients will need dual anti-
platelet therapy, including aspirin and another antiplatelet agent,
for a certain period of time.
The third subset of patient is patient with atrial fibrillation. We
know that these patients are very high risk of stroke but also
often at high risk of bleeding. According to patient bleeding and
thrombotic risk, oral anticoagulation only, without aspirin, may
be a good option.
And the last group of patients is the Valve-in-Valve group, where
a TAVR device was implanted inside a failed surgical bio-
prosthesis. While still unknown, these patients may be at higher
risk of valve thrombosis, and may deserve stronger antiplatelet
therapy, and potentially early anticoagulation therapy. Further
studies are needed among this specific group of patients.
In conclusion, the future of TAVR procedure is without any
doubt very bright. That being said, fine tuning and optimization of
post -TAVR care is mandatory if the full benefit of this incredible
technology is to be achieved among all treated patients.
10. 025门诊 CLINIC
Physicians’Viewpoints 专家观点·东闻视野
Dr. Junbo Ge: Indeed, the safest and most effective post-
procedural antithrombotic strategies are what we urgently need,
but they are in suspension up until now however. Nowadays,
a great deal centers execute DAPT of Aspirin+Clopidogrel
lasting 1~3 months, and then convert to Aspirin alone. However,
relevant studies have been reported of the issue that Aspirin
compared with Aspirin+Clopidogrel both dosing for 30 days
shows no difference in outcomes. In our center, we would like to
employ DAPT on patient at a relatively high bleeding risk whose
HAS-BLED score is equal to and above 3 lasting one month
followed by Aspirin alone; if extremely high risk, mono-therapy
of Aspirin is considered from the initiate.
Dr. Yan Wang: It is quite important to optimize
individualized Antithrombotic therapy for each TAVR patient
to reduce the occurrence of clinical outcomes. When lacking
of the good-quality randomized controlled clinical studies, we
can still consult the high-level clinical evidences of antiplatelet
and anticoagulation therapies on other diseases. And we need
estimate the risk of thrombosis, embolism, bleeding and use
(more than) one reasonable therapies to find out the best balance
between bleeding and thrombosis risk according to the distinct
scenario of every individual patient respectively.
ESC Guidelines have recommended that the ACS patient who
is supposed to receive interventional PCI procedure is excluded
with TAVR population. And it is also a considerable option
to deploy simple angioplasty or bare stent on patient at high
risk to shorten the bout of DAPT. To those PCI patients who
need long-term medication of Vitamin K antagonists, triple
antithrombotic therapy is better limited in 2 weeks after that
Vitamin K antagonist combined with a single antiplatelet agent is
alternatively considered. And one of the Vitamin K antagonists
alone is the safer regimen for patient 3~6 months after TAVR.
TAVR术后最优化的个体化抗栓治疗策略
《门诊》：作者在PARTNER试验结论的最后呼吁，优化个体化治疗方案；术后采
用更合理的抗栓策略是TAVR临床治疗这样一个高危患者群体最紧迫的需要。因此
依您的观点，如何是更为合理、能够提高患者真实获益的抗栓治疗？
Gregg W. Stone教授：抗血小板和抗栓药物都会
增加出血风险。目前我们还未知TAVR术后患者最佳的抗栓
策略是阿司匹林单抗、阿司匹林联合氯吡格雷，或是氯吡格
雷单独使用；以及抗血小板治疗时间该持续多久。华法林虽
然进一步增加出血风险，然而它对于房颤患者是至关重要的
药物。下一个阶段的研究方向，需要关注多种抗栓药物联合
使用的适用人群，即明确多种抗栓药物联合治疗对于哪一患
者人群既产生获益又具有合理的安全性。
Philippe Généreux教授：首先我们需要做的是
将患者进行分类。每一个患者都具有个体差异，并且每一种
治疗策略都无法适用于所有人群。临床上大致可将患者分为
四类人群。
第一类人群是严重主动脉瓣狭窄，但既没有冠脉疾病又
不合并房颤的患者。这一个患者群体的卒中和出血风险都很
低，因此低强度的抗血小板治疗策略较为适合。
第二类人群是严重主动脉瓣狭窄，在过去的12个月内曾
行PCI支架术的患者。这些患者自然需要接受双联抗血小板
药物治疗，包括阿司匹林与另一种抗血小板药物联合用药，
维持一段时间的治疗期。
第三类人群是房颤患者。我们都清楚房颤患者具有很高
的卒中风险，而同时又存在与卒中同等程度的出血风险。基
于这一患者人群的出血及血栓形成风险，我们认为在口服抗
凝药物之外不再增加阿司匹林的治疗，是最佳治疗策略。
最后一组人群是瓣中瓣患者，即外科手术治疗失败后，
通过TAVR手段在原先植入的瓣膜内植入另一个瓣膜。目前
对这一个人群的事件风险仍不十分明确，我们只能认为这一
人群可能具有更高的瓣膜血栓风险，因此可能需要强度更高
的抗血小板治疗，以及潜在需要从更早期开始服用抗凝药
物。对于这一特殊人群我们有待进一步的研究结果。
11. 026 门诊 CLINIC
东闻视野·TAVR探索 The TAVR
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Hansen ML, Sørensen R, Clausen MT, et al. Risk of bleeding with
single, dual, or triple therapy with warfarin, aspirin, and clopidogrel
in patients with atrial fibrillation. Arch Intern Med. 2010 Sep
13;170(16):1433-41.
王建，王焱。新型心脏植入器械血管入路和入路相关并发症的预防。
《国际心血管病杂志》，刊印中。
Escárcega RO, Lipinski MJ, Magalhaes MA, et al. Impact of blood
transfusions on short- and long-term mortality in patients who
underwent transcatheter aortic valve implantation. Am J Cardiol. 2015
Jan 1;115(1):93-9.
[1]
[2]
[3]
[4]
[5]
[6]
[7]
[8]
[9]
[10]
[11]
[12]
[13]
[14]
[15]
[16]
[17]
综上所述，TAVR毫无疑问是一个充满发展前景的术
式。然而话虽如此，我们必须先达到TAVR术后更精细并更
优化的医疗护理，才能期待这一个了不起的技术能够为所有
治疗患者带来最大获益。
葛均波院士：关于TAVR术后最优化的抗栓治疗策略
目前尚不清楚。目前许多中心采用阿司匹林＋氯吡格雷双联
抗1～3月，后改为阿司匹林。但已有研究显示仅仅接受阿司
匹林的患者30天心血管事件发生率与服用双联抗血小板药物
（阿司匹林＋氯吡格雷）相比并无差异。我们倾向于对于出
血风险比较高的患者（HAS-BLED评分≥3分）采用双联抗
血小板药物治疗持续1月，后改为单用阿司匹林。而对于出血
风险高的患者单用阿司匹林。
王焱教授：个体化地针对每一位接受TAVR患者制定
最佳的抗栓策略，对于减少临床终点事件的发生是极为重要
的。在缺乏高质量随机对照的临床研究时，我们仍可以借鉴
或结合以往针对其他疾病高质量的抗血小板、抗凝的临床证
据。针对患者的实际临床情况，评估其血栓、栓塞、出血风
险，合理地使用其中的一种或联用，找到出血与血栓栓塞之
间的最佳平衡点。目前，ESC指南要求在TAVR术前排除患
者有需要介入干预的冠心病，单纯的血管成形或裸支架植入
以缩短出血高危患者的双联抗血小板时间是一种可以考虑的
选择；对于需要长期使用维生素K拮抗剂的PCI患者，三联抗
栓治疗最好限制于2周以内，之后改为维生素K拮抗剂联合单
一的抗血小板药物，3～6个月后改为单一的维生素K拮抗剂
则更为安全。
12. 027门诊 CLINIC
Questions Extension 话题延展·东闻视野
Topic Extension: Future Developing Trends
Dr. Gregg W. Stone：Cohort C patients for the next
phase are those who are too ill to benefit from TAVR. While
there is no single universally agreed upon definition, this would
include patients with severe dementia, those who are bedridden
for numerous reasons such as a severe stroke, comatose patients,
those with metastatic cancer and life expectancy of only a few
months, etc.
Dr. Junbo Ge: Thus far, the trial of PARTNER 2 is
underway, and is anticipated to be completed by December 2015.
In PARTNER 2, the patient recruited is patient at intermediate
risk (STS 4-8) on whom because the setting of this trial to
compare TAVR with SAVR. Since it has proved the outcomes of
TAVR procedure on patient inoperable or not suitable for surgery
due to high risk, the next necessity that is urgently to be known is
to observe TAVR therapy on intermediate risk population who is
a larger subset then.
Dr. Yan Wang: Up until now, there still have been many
questions about TAVR that need answering. For example, the
existing Guidelines suggest that patient with severe aortic stenosis
at a high risk for Surgical AVR is the eligible candidate for
TAVR procedure, however, no Guideline by now has indicated
any predictive tools/means for procedural risk or complications of
TAVR. supposed that TAVR will be widespread in future, it will
be of vital importance for the new centers to have the capacity
to screen eligible patient properly. And we urgently need one
or more tools to estimate prognosis and complications for every
individual after TAVR.
Currently, the "standard outcomes" — a kind of predictive tool
based on VARC-2 is put in use in our center to predict the clinical
events of every post-TAVR individual so that we may adjust
the procedural strategies [changing procedural access, devices
(including valve) etc] accordingly considering every event that
may happen if conditioned. And we find that our predictive work
contributes to a significant reduction of the complications related
to procedure.
with my point of view, the next important problem to be solved
is that we need more evidences to exclude the patient who is
contraindicated to TAVR procedure instead of to further expand
the indications for TAVR therapy.
Dr. Yongjian Wu: In current years, the studies on TAVR are
mostly focused on procedure such as, how to reduce paravalvular
leak (PVL) and permanent pacemaker implantation or how to
improve procedural success rate of valve replacement which are
always what are investigated in researches. This study released
not long ago in 2014 in JACC really highlighted the problem of
bleeding after procedure. While we need ask why has the bleeding
complications not been brought to the forefront in the past 10
more years?
Reviewing the data of the limited cases (near 200 procedures)
achieved in China, those mentioned as above including the
procedural success rate were indeed the very concernings of the
researchers. However the major bleeding complications were
somewhat disregarded.
Now we know that the MLBCs were at a rate of 6% as shown in
this study which was far above our expectation. But I personally
think a larger amount of evidence is what is needed to further
clarify this bleeding risk after TAVR. And we cannot verdict if
TAVR will be kept from being spread due to the rate of MLBCs
(between 30 days to 1 year) after TAVR at present when it is still
too early to say. While one thing we can affirm is that the bleeding
complications after TAVR are decreasing since the recruitment
of the patient at younger age and at intermediate risk. Although if
patient at intermediate risk eligible to TAVR is still on the carpet,
we all know that age (and age related factors) are within the
highest risk factors leading to Post-TAVR bleeding events.
It is assured that individualized (based on baseline) therapies and
optimized antithrombotic regimens are definitely the solutions to
diminish bleeding risk after TAVR.
14. 029门诊 CLINIC
Editorial 述评·东闻视野
TAVR to China: A Second Interventional Evolution,
Or A Second Industrial Revolution?
procedurally and post-procedurally no matter in medication or
device profile. And that we see and foresee TAVR therapy of its
achievements in nowadays and impact for future with a soberly
global insight is of vital importance for us Chinese interventional
world. “Because we are already standing on a cross road, and it
is the time we must decide strategically what to do next?” The
editorialist of Clinic•Cardiology calls on.
The most crucial questions remained for TAVR to resolve
with are mainly focused on Long-term valve durability, stroke
complications, cost-effectiveness, and antithrombotic therapies
after procedure. And now, we have CoreValve High Risk Trial
to describe the trends in cost-effectiveness of TAVR relative to
surgical AVR, PARTNER 1 that proved the 5-year mortality and
valve durability findings and its continued access PARTNER
TAVR——Transcatheter Aortic Valve Replacement is an incredible technology raised up specifically for severe
aortic stenosis——today, we talk about TAVR. How is TAVR in east; how is TAVR in west? What has TAVR
caused; what has TAVR brought? What does TAVR mean to interventional world; what does TAVR mean
to China? Be set up on Clinic·Cardiology "The TAVR" in March.
TAVR technology in East and West Nowadays
It is not debatable to say that TAVR is a budding technology,
while it is quite controversial to say TAVR is a beneficial therapy
in clinic.
This novel technology of TAVR is specialized in severe aortic
stenosis that is inoperable or not suitable for surgery. It has
passed through more than decade having been employed on
around 160,000 patients throughout the world. And during this
span since its being emerged may be reckoned the germinating
era of TAVR. Yes, TAVR seems to pace its way slowly, while we
have to realize that TAVR is reaching maturity in every different
aspect. After all, the advanced age associated risk factors and
multiple complications of the eligible treated patient that is the
frailest population require it to achieve the refining therapy both
15. 030 门诊 CLINIC
东闻视野·述评 Editorial
Registry showing the Major Late Bleeding Complications
(between 30 days and 1 year) after TAVR, and also we have
acquainted with the efficacy of embolic protection devices
measured in key clinical trial for procedural stroke prevention
from CLEAN-TAVI. And with the device profile improvement,
and with the operator growing in skill, we are seeing TAVR has a
bright future with a worldwide view.
When TAVR is without any doubt shown perspective in results of
varying Trials and real-world Registries, we need be alerted since
all the clinical evidences to critically guide TAVR practice are
from western areas, meaning none is achieved at home among
Asian/Chinese population.
But we are still delighted that we do have evidence-based trial
that recruited hundreds of patients who were all for TAVR
procedure by far in mainland China. While, if the guidance to a
TAVR clinic of a country, the data on no more than 200 cases is
surely lacking of power or significance.
A TAVR Evolution is Approaching
Thus, we can easily find our vigilance and awareness now of the
defect and deficiency of our TAVR clinic while in the context of
THE TAVR developed and keeping going on in the west, either
in devices including valve profile and embolic protection devices
or in procedure such as Valve-in-Valve. But the awareness alone
is not what avails to make the difference, instead of which to
work on the roots causing the hindrance and constraints that
keeps the TAVR at home from flourishing and growing is what
we urgently need devote ourselves to. And we all know that,
they are the too high cost of undergoing this procedure beyond
majority of eligible patients at home, inadequate medical care
after procedure, the tremendously unbalanced medical resource
distribution between the centers in developed cities and that in
undeveloped cities, so and so.
And how can we conquer and break all these barriers? Maybe
the answer is in tracing the first interventional evolution: PCI
evolution——it was the era when the PCI techniques developed
and procedures increased dramatically that was reckoned as
the first interventional evolution in the overall cardiovascular
world. In the first evolution, Chinese PCI techniques fully
triumphed; the indigenous DES scaffold of Firehawk (Microport)
was victorious over the strong competitors overseas and utterly
approbated as good as (non-inferior to) the first-classic DES
scaffold: Abbott (Abbott Laboratories) in numerous areas all
over the world including where the PCI procedures and scaffold
technologies are the most developed.
How did the home PCI procedures and indigenous scaffold
technologies prevail during that evolutional era under the same
restrictions? The answer is that “we did everything and nothing”.
The governors realized the technology; the cardiologists realized
the era; we put our all in it, and we made a go of it. And the issue
is what it is. Now we see Chinese scholars’ academic reports,
Chinese physicians’ procedure demonstration, and Chinese
scaffolds deployment in PCI category almost everywhere and
every day. It really means something to us, it meaning we CAN
MAKE IT, and we MADE IT if we MAKE IT.
Challenge and Opportunities We are Meeting Again
There is explicitly a TAVR evolution before us and also the
overall interventional cardiologists. That TAVR is a viable option
and worth bright future is what is ascertained, and to some
extent this evolution is already underway. Now we are standing
on the cross road it has just begun, and when we go through
all the processes of the TAVR evolutional era, where will we
be standing, the home TAVR procedure and indigenous bio-
prosthesis?
We know that we have the randomized trial of around 200
recruitments, and will the Chinese TAVR procedures address to
the world? We know that we possess our own valve techniques of
Venus A Valve, and will it indispensable and be a Valve among
the first-classic devices with Edward Sapien and CoreValve? The
TAVR evolution era is unveiled, and the opportunities are open.
For THE TAVR in China, whether it is the second interventional
evolution unto maturity or the second industrial revolution unto
elimination is all hinged on what we are to do to respond to the
challenge and opportunities put before us at the present hour. It is
the strategic time for us to realize it and make the decision.
Clinic Editorialist: Rahab Jin
《门诊》评论员: 金瑜冰
