Introduction
In this prospective randomized study, whether an ART with a single antiplatelet therapy strategy (aspirin alone) was associated with morbidity and increased patient morbidity compared to the dual antiplatelet strategy (aspirin and thienopyridines). Transcatheter aortic valve replacement (TAVR) has emerged as an important treatment option for patients with aortic stenosis (AS). The SOCIAL and CoreValve tests showed that TAVR was superior to medical therapy in treating inoperable patients with severe AS and non-surgical lower than in April (SAVR) in patients with severe AD who were high-risk and intermediate. These TAVR tests have prominently positioned as an alternative to SAVR, but the clinical benefits of TAVR should be assessed in balance with peri-procedural complications, in particular strokes and coagulation (Table 1), which are associated with increased morbidity and mortality.
METHODS Study design
The retrospective investigation was performed in a singular focus planned associate review was going for continuous enrollment of all patients experiencing TAVR systems at the Heart Center Segeberger Kliniken, Bad Segeberg, Germany. Information accumulation was affirmed by the nearby morals board of trustees and educated, composed assent was gotten from all patients. The present investigation incorporates 514 back-to-back patients who experienced TAVR between September 2007 and December 2014 at the Heart.
Focus Segeberger Kliniken, Germany. Twenty patients were avoided from this investigation in light of antithrombotic medicines other than DAPT or OAC, or because of system-related demise. TAVR was performed in all patients with CE-checked gadgets. TAVR methods were led using trans-femoral, trans-subclavian, trans-apical or trans-aortic get to destinations. Gadget achievement was characterized by the Valve Academic Research Consortium 2 (VARC-2) agreement record, which is a specialized composite end point including active vascular get to, conveyance and arrangement of the gadget and fruitful recovery of the transportation framework; rectify position of the device in the correct anatomical area; expected execution of the prosthetic heart valve (aortic valve zone [AVA] > 1.2 cm2, mean aortic valve inclination < 20 mm Hg, or pinnacle speed < 3 m/s, without direct or severe prosthetic valve aortic spewing forth as surveyed by post-interventional transthoracic echocardiography [TTE]) and having just 1 pipe embedded in the best possible anatomical area.
Patients were classified into two gatherings given the antithrombotic treatment set up after TAVR. The DAPT aggregate comprised of 315 (61.3%) patients treated with a mix of oral headache medicine and clopidogrel for three months taken after by long lasting ibuprofen treatment. The OAC amass included 199 (38.7%) patients treated with a blend of an oral anticoagulant and clopidogrel for three months taken after by OAC alone (Fig. 1). In patients treated with associative percutaneous coronary mediation (PCI) and medication eluting stent implantation antithrombotic treatment with DAPT or blend of OAC + clopidogrel was sought after for up to 6 months.
Development and study endpoints
All patients in the registry had a pre-characterized clinical and transthoracic echocardiographic (Vivid 7 Ultrasound Machine and an M4S lattice exhibit area transducer GE Medical Systems, Milwaukee, WI, USA) follow-up at 30 days, six months and one year. Extra transesophageal echocardiography (TEE) assessment was performed in instances of exacerbating indications or suspected valve thrombosis, characterized as valve brokenness (mean transvalvular angle > 20 mm Hg, a decrease of the AVA to < 1.2 cm2 or new onset more than gentle transvalvular spewing forth) or recently evident portable mass suspicious of thrombus, independent of brokenness, and without the disease.
Moreover, multidetector figured tomography (MDCT) examination was performed to affirm the finding of suspected valve thrombosis additionally. CT scan was finished with a moment-era second source CT scanner (Somatom Definition Flash, Siemens Healthcare, Forchheim, Germany). Differentiate upgraded ECG-gated obtaining of the aortic root was performed after infusion of iodinated balance operator with the area of intrigue put in the ascending aorta and central areas of 0.6 mm. All information was exchanged to a devoted post-handling workstation (Syngo Multimodality Workplace, Siemens Healthcare, Forchheim, Germany) for examination. Pictures were assessed for hypoattenuating zones with or without decreased portability of at least one handouts identifiable in two distinct projections. Valve thrombosis was ordered in light of the planning of finding after TAVR as intense (0–10 days); subacute (11–30 days) or late (> 1 month).
Pre-determined viability endpoints of this review were characterized as all-cause demise, myocardial localized necrosis (MI), stroke and clinical valve thrombosis at 30 days, six months and one year. The key viability endpoint was a composite of all at one year. The key wellbeing endpoint was the event of life debilitating or significant sleeping at one year. Singular endpoints were characterized by the VARC-2 criteria for occasion definition.
Measurable investigation
Constant information is accounted for as mean ± standard deviation (SD) for regularly circulating factors and as the middle with interquartile extend for non-ordinarily appropriated elements. All out factors are accounted for as some patients (% of patients). Typically, and non-ordinarily circulated factors were looked at utilizing the Student’s t-test or the Mann-Whitney U test appropriately. Correlations between independent factors were performed using the χ2 or Fisher’s correct test, wherever fitting. Keeping in mind the end goal to recognize whether the counter thrombotic treatment methodology was prescient of all-cause mortality, cardiovascular mortality, stroke, significant dying, or consolidated adequacy and wellbeing endpoints multivariable twofold calculated relapse investigation was performed. Factors which achieved a p-esteem < 0.1 on univariate paired relapse examination were incorporated into the model. Factors are balanced for age, sex, body mass record (BMI), AF and arranged PCI. All tests were two followed and a p-estimation of < 0.05 was considered as actually noteworthy. Every one of the examinations was review and performed utilizing STATA from 14 (STATA Corp., TX, USA) or (SPSS, Release 22; SPSS Inc, Chicago, IL).
RESULTS
A sum of 514 consecutive patients that experienced TAVR at the showed Foundation were incorporated into this review. The mean age of the review populace was 80.4 years, 43.7% were guys, with an average strategic EuroScore of 18.49%. In both gatherings, patients had severe aortic stenosis. Echocardiographic attributes did not contrast fundamentally in either gathering. The mean (± SD) inclination was 46 ± 16.8 mm Hg in the DAPT collection and 44 ± 16.8 mm Hg in the OAC conference (p = 0.27). The ordered AVA was 0.41 ± 0.2 cm2/m2 and 0.39 ± 0.2 cm2/m2 (p = 0.28). The two gatherings had comparable pattern attributes (Table 1), with the exception of a higher rate of AF in the OAC gathering (10.5 versus 69.2%; p < 0.01) and a higher rate of arranged PCI in patients experiencing TAVR in the DAPT gathering (40.1 versus 28.3%; p = 0.01). Procedural attributes did not vary between either gathering (Table 2). At release, 315 (61.3%) patients got DAPT and 199 (38.7%) a blend of OAC and clopidogrel (n = 188 phenprocoumon, n = 7 rivaroxaban, n = 4 dabigatran) taking after TAVR (Fig. 1).
Results at 30 days
At 30 days, all-cause mortality happened in an aggregate of 18 patients (3.5%), 11 (3.5%) in the DAPT gathering and 7 (3.5%) in the OAC gathering (p=0.98) (Table 3). Cardiovascular mortality was accounted for in 3.5% of the patients in the DAPT gathering and 2.5% in the OAC gathering (p = 0.61). There was no huge distinction between either gather in the frequency of MI (0.9% versus 0.5%, p = 1.0), stroke (3.8% versus 3.5%, p = 0.86) or valve thrombosis (0.3% versus 0%, p = 1.0) at 30-days. Additionally, security endpoints did not contrast between either gathering: life-debilitating dying (7.3% versus 9.5%, p = 0.36) and significant dying (16.8% versus 15.1%, p = 0.60).
Results at six months
At six months, all-cause mortality was accounted for in 25 (7.9%) patients in the DAPT gathering and 24 (12.1%) patients in the OAC meeting (p = 0.15) (Table 4). There was no noteworthy distinction amongst DAPT and OAC bunches in the frequency of MI (1.6% versus 0.5%, p = 0.41) and stroke (4.5% versus 4.1%, p = 0.83). In spite of the fact that valve thrombosis was just detailed in the DAPT gathering, there was no critical contrast (1.9% versus 0%, p = 0.08) between the groups following six months. Consolidated adequacy (15.3% versus 14.6%, p = 0.8) and security (24.4% versus 26.1%, p = 0.64) endpoints at 6 months did not contrast essentially (Table 4).
At one year all-cause mortality had happened in an aggregate of 74 (14.4%) patients. 39 (12.4%) passings were accounted for in the DAPT gathering and 35 (17.6 %) in the OAC collection (Fig. 2). Despite the fact that a pattern towards a higher death rate could be seen in the OAC gathering, this expansion did not achieve factual essentialness (p = 0.09). Besides, there was no distinction in MI (2.9% versus 0.5%, p = 0.09) and stroke (5.2% versus 4.1%, p = 0.67) rates between the DAPT and OAC gatherings. Following one year, 8 (2.5%) instances of valve thrombosis were recorded in the gathering of patients on antiplatelet treatment, while in patients on OAC no valve thrombosis was accounted for (2.5% versus 0%, p = 0.02). Joined key viability (21.5% versus 19.7%, p = 0.61) and security (25.1% versus 27.8%, p = 0.53) endpoints at 1 year did not contrast between the gatherings (Fig. 3). A balanced calculated relapse investigation affirmed that notwithstanding a pattern towards an expansion taking all things together causes mortality following one year was seen in patients under OAC, there was no general huge distinction in the event rates of the predefined endpoints (Fig. 3). In any case, OAC diminished the danger of valve thrombosis-free of age, sex, BMI, AF and whether organized PCI was performed (OR 0.53; 95% CI 0.23–0.76).
In the present examination, transcatheter heart valve (THV) thrombosis was accounted for in 8 patients with a mean age of 78.7 years. Middle and interim to the finding of THV thrombosis were 181 (interquartile go 176–263) days and 196 days, individually. THV thrombosis was thought to be subacute in 1 and late in 7 patients (Table 5). Each of the eight instances of THV thrombosis happened in the DAPT gathering. While two patients were still under DAPT (headache medicine/clopidogrel) 6 patients were under ibuprofen monotherapy at the point in time of the finding of THV thrombosis. Instances of valve thrombosis included seven patients who had experienced TAVR with an inflatable expandable THV and one tolerant treated with a self-expandable THV. Three cases of THV thrombosis happened in patients who underwent TAVR for the treatment of declined surgical bioprosthesis (valve-in-valve). Declining dyspnoea was the main clinical sign of THV thrombosis and was seen in 5 patients. In the other three patients, no clinical side effect could be ascribed to the event of THV thrombosis. No instance of stroke, MI or fringe embolism could be related to THV thrombosis.
Lifted transvalvular angles were the main finding in all patients on TTE examination. The pinnacle and mean transaortic angles at the season of the finding of THV thrombosis were 61 mm Hg and 39 mm Hg, individually. TEE was performed in all patients with suspected THV thrombosis. TEE discoveries included limited handout versatility (n = 3), thrombotic mass (n = 3) and thickened flyers (n = 4) (Table 5). In 1 case TEE was uncertain. CT examination was performed in 4 patients and showed hypoattenuating injuries of the pamphlets and limited flyer movement predictable with THV thrombosis. All patients determined to have THV thrombosis were treated with VKA in restorative measurements.
Three patients were dealt with likewise with clopidogrel. Under oral anticoagulation follow-up, TTE examinations reported a reduction of the transvalvular slopes in all patients. Follow-up CT was performed in 3 patients 1 (n = 2) and 2 (n = 1) months after the start of anticoagulant treatment affirmed the determination of the hypoattenuating injuries and flyer thickening with the rebuilding of pamphlet movement. After determination of THV thrombosis, OAC was stopped in 3 patients while VKA treatment proceeded in 5 patients. No repeat of THV thrombosis was accounted for.
DISCUSSION
This individual tracer screening test analyzed the results of two antithrombotic regimens after TAVR intake. After a subsequent 1-year period, no significant total endpoint feasibility and safety contrasts were observed between an antithrombotic in the light of the DAPT initial phase of 3-6 months the technique as suggestions indicated the existing rule
What’s more, OAC. However, clinical valve thrombosis occurred after TAVR at the DAPT meeting and was effectively treated by the OAC foundation.
Most cardioembolic events after TAVR were considered to happen in the primary days after TAVR. In this review, the 30-day death rate for all causes, stroke, and IM was similar to what is already distributed at the next test point of testing and even across the record country. DAPT or OAC post-intervention has produced comparable rates of myocardial infarction, stroke and death for all cause up to 6 months after TAVR, then underlining the vitality of both useful regimens. After six months, patients who meet fixed DAPT in anti-tumor therapy (headache medication), while the anticoagulant sought in the OAC group due to concomitant diseases, in particular, paroxysmal or life. One year later TAVR, single-drug monotherapy for a headache also provided comparative results when compared to OAC compared to predetermined evaluation criteria. Therefore, actual results agree with previous reviews strongly support DAPT interference after a 3-6 month TAVR in patients who have no other sign for DAPT, for example, end-of-coronary heart disease (<12 Months) O coronary stent implant (<6 months)]. It is interesting to note that after one year, independently altering an FA event and different factors, a pattern could be observed to increase mortality from all causes at the OAC meeting. review given the limited size of the revision population and also the correction mode, this perception requires clarification of the vigils.
In replacement of moderately young perinatal aortic valve period, he developed an increasing number of reports describing the post-TAVR thrombocytic subacute cases clinically appropriate application and delayed movement delayed movement MDCT recognized may be related to subclinical replacement valve thrombosis.
This valve and post-TAVR work rotate broken thrombosis reports created about the clinical relevance of this wonder. In this review, thrombosis of the valve given the echocardiographic examination routine to follow up with 1.5% of the total population and as regularly as 2.5% in patients initially treated with DAPT was analyzed. The conclusion depended on echocardiographic parameters that showed a significant increase in transvalued angulation or thrombotic mass weight and asserted by the results revealing MDCT thickening of the flaps and reduced brochure movements. THV thrombosis showed an aggravation of dyspnea in 5 out of 8 patients and was not related to any clinical manifestation in 3 patients.
In patients with THV thrombosis, DAPT was switched to OAC for not less than three months; follow-up ranges were shortened. By echocardiography and also the clinical examination reported the reconstruction of the valve capacity under OAC by reducing pelvic and medical transvaginal course on the valve prosthesis, the determination of thrombotic mass and a further change of clinical side effects to all patients. Interestingly, rather than collecting DAPT, no thrombosis valve cases were analyzed in any of the patients in OAC and calculated the relapse test showed that OAC was associated with a risk primarily to reduce THV thrombosis. This perception agrees with current editorial reports suggest that OAC treatment still prevents platelet thrombosis or
Reduced aortic leaf movement, which can speak of subclinical valve thrombosis. Further studies are needed with a specific end goal to represent this patient subgroup better and distinguish indicators show potential patients who may benefit from OAC after separating different signs for TAVR anticoagulant therapy.
Hemorrhagic disadvantages are continuous and significant side effects, or life-wasting after TAVR checks about 20-30% and 15%, individually [16, 17, 29]. Despite the fundamental components, disabling or debilitating discharge life is a critical indicator of great and late mortality in patients undergoing TAVR. Drainage indicators have been distinguished for a couple of encounters [30, 31]. Including vascular tonsils or into processed tonsils, female sex, and pallor series have been detailed most of the time. While periprocedural drainage is driven primarily by anatomical and specialized contemplations, greater drainage and subsequent post-mining life indicate that time is predominantly linked to the patient’s drainage vulnerability, the current antithrombotic operator used.
In this research, the criterion of being composed occurred mainly within the first six months after TAVR at both meetings. This perception unequivocally suggests that DAPT is OAC mixing with a self-agonizing drug alone, for example, clopidogrel results in a sharp increase in complexity bleeding after TAVR in a population of patients at high risk of loss due to morbidity and lightness. At one year, the composite safety criterion frequency was only slightly greater in both meetings when compared to the 6-month time point and was identified primarily in the manner following a 6-month high thienopyridine treatment stopped in patients without A sign for the further treatment of long-distance clopidogrel, for example, ACS. Past reviews and records have announced a fleeting risk identified with the confusion of drainage being the clearest in the first three months since the beginning of the VKA plus a single anti-drug or DAPT treatment. A new meta-search excludes OAC patients have shown that monotherapy head pain while being as efficient as DAPT in predicting thromboembolic complexity and post-intervention has been better than DAPT on difficulties.
Taken together these perceptions may challenge the present work on prescribing DAPT for 3–6 months after TAVR yet these outcomes should be affirmed by at the moment continuous planned randomized trials. On the administration of antithrombotic treatment after TAVR in patients on OAC, facilitate information announcing is justified. In this review examination patients on OAC were treated with clopidogrel for no less than three months after TAVR as indicated by popular suggestions [4]. Since most of the draining occasions happened in this gathering inside the initial six months, the net advantage of including a platelet inhibitor top of OAC might be addressed. Concerning DAPT, imminent randomized trials are required to characterize the most suitable antithrombotic post-TAVR treatment in patients on OAC. Finally, while the more popular direct oral anticoagulants have turned out to be more secure and at any rate as proficient as VKA in anticipation of thromboembolic occasions in patients with fundamental non-valvular AF, their part in patients experiencing TAVR stays to be characterized.
Conclusion
TAVR – is the transformation and development of treatment for patients with severe aortic stenosis. Cases of peri-procedure stroke and exhaustion related to dramatic horror and death in patients with the mark. Deep holes remain in our lack of adjunctive antithrombotic treatments to increase the risk of thromboembolic changes and cases of leakage in the lower and TVR. Agreements and recommendations for modern judicial standards require anticoagulation with unfractionated heparin vnutriprotsedurnoy and to maintain ACT extends 250-300, and are administered to patients after the mark, to achieve DAPT for 1-6 months with clopidogrel, without leaving pharmacological treatment of headaches. There is a need for a fantastic clinical synthesis to advise the standards and apply the best treatment protocol that is taken after TVAR. Numerous clinical studies on adjuvant antiplatelet therapy and anticoagulant therapy after TAVR. Several randomized clinical trials provide clinically vital, highly anticipated clinical research in the perfect pharmacological system, strength and duration of antithrombotic treatment after TVAR. The future clinical examination would also require the creation of equipment hazard expectations used to detect the net benefits and risks of adjuvant antithrombotic therapy in this heterogeneous patient population.
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AP P E N D I X
| DAPT (n = 315) OAC (n = 199) p | |||||||
| All cause death | 
25 (7.9%) |
24 (12.0%) |
0.15 |
||||
| Cardiovascular death | 16 (5.0%) | 14 ( 7.0%) | 0.12 | ||||
| Myocardial infarction | 5 (1.6%) | 1 (0.5%) | 0.41 | ||||
| Stroke, all | 14 (4.4%) | 8 (4.0%) | 0.83 | ||||
| Transcatheter heart valve thrombosis | 6 (1.9%) | 0 (0%) | 0.08 | ||||
| Combined efficacy endpoint | 48 (15.2%) | 29 (14,6%) | 0.86 | ||||
| Major bleeding | 55 (17.5%) | 33 (16.5%) | 0.80 | ||||
| Combined safety endpoint | 76 (24.1%) | 51 (25.6%) | 0.64 | ||||
| DAPT (n = 315) OAC (n = 199) p | ||||
| 5 (1.6%) | 1 (0.5%) | 0.41 | ||
| 14 (4.4%) | 8 (4.0%) | 0.83 | ||
| 6 (1.9%) | 0 (0%) | 0.08 | ||
| 48 (15.2%) | 29 (14,6%) | 0.86 | ||
| 55 (17.5%) | 33 (16.5%) | 0.80 | ||
| Age (years)
Women
Hypertension
Diabetes mellitus Peripheral vascular disease Porcelain aortaCongestive heart failure*
Previous myocardial infarction
Previous stroke
Previous transient ischemic attack
Previous coronary artery bypass grafting Previous cardiac surgery†
Previous percutaneous coronary intervention Chronic obstructive pulmonary disease
Liver cirrhosis
Chronic kidney failure
Permanent atrial fibrillation
Previous aortic valvuloplasty
Previous pacemaker
New York Heart Association class III and IV Echocardiographic findings
Mean gradient (mm Hg) Aortic valve area (cm2) |
76 (24.1%) | 51 (25.6%) | 0.64 | |
| Valvular Heart Disease/Antiplatelet Therapy After TAVI | 1773 | ||||||
| Table 1 | |||||||
| Baseline clinical and echocardiographic characteristics | |||||||
| Variable | Overall | DAPT | Aspirin | p Value | |||
| (n 79) | (n 40) | (n 39) | |||||
| Age (years) | 81 4 | 80 6 | 81 4 | 0.68 | |||
| Women | 43 | (54%) | 20 | (50%) | 23 | (59%) | 0.44 |
| Hypertension | 66 | (84%) | 35 | (88%) | 31 | (80%) | 0.96 |
| Diabetes mellitus | 21 | (27%) | 13 | (33%) | 8 | (21%) | 0.35 |
| Peripheral vascular disease | 7 | (9%) | 3 | (8%) | 4 | (10%) | 0.43 |
| Porcelain aorta | 2 | (3%) | 1 | (3%) | 1 | (3%) | 0.72 |
| Congestive heart failure* | 32 | (41%) | 18 | (45%) | 14 | (36%) | 0.65 |
| Previous myocardial infarction | 11 | (14%) | 7 | (18%) | 4 | (10%) | 0.31 |
| Previous stroke | 6 | (8%) | 2 | (5%) | 4 | (10%) | 0.28 |
| Previous transient ischemic attack | 4 | (5%) | 2 | (5%) | 2 | (5%) | 0.68 |
| Previous coronary artery bypass grafting | 6 | (8%) | 2 | (5%) | 4 | (10%) | 0.28 |
| Previous cardiac surgery† | 3 | (4%) | 2 | (5%) | 1 | (3%) | 0.55 |
| Previous percutaneous coronary intervention | 21 | (27%) | 12 | (30%) | 9 | (23%) | 0.35 |
| Chronic obstructive pulmonary disease | 17 | (22%) | 10 | (25%) | 7 | (18%) | 0.60 |
| Liver cirrhosis | 1 | (1%) | 0 | 1 | (3%) | 0.47 | |
| Chronic kidney failure | 11 | (14%) | 6 | (15%) | 5 | (13%) | 0.92 |
| Permanent atrial fibrillation | 10 | (13%) | 4 | (10%) | 6 | (15%) | 0.29 |
| Previous aortic valvuloplasty | 42 | (53%) | 24 | (60%) | 18 | (46%) | 0.45 |
| Previous pacemaker | 5 | (6%) | 4 | (10%) | 1 | (3%) | 0.22 |
| New York Heart Association class III and IV | 49 | (62%) | 26 | (65%) | 23 | (59%) | 0.60 |
| Echocardiographic findings | |||||||
| Mean gradient (mm Hg) | 53 17 | 52 6 | 57 18 | 0.23 | |||
| Aortic valve area (cm2) | 0.6 0.2 | 0.6 0.2 | 0.6 0.3 | 0.70 | |||
| Left ventricular ejection fraction (%) | 52 12 | 51 12 | 54 8 | 0.49 | |||
| Logistic EuroSCORE (%) | 21 13 | 23 15 | 21 16 | 0.60 | |||
| Society of Thoracic Surgeons score (%) | 7.3 4 | 8 5 | 7 3 | 0.37 | |||
| Variable | Overall | DAPT | Aspirin | p | |||||||
| (n 79) | (n 40) | (n 39) | Value | ||||||||
| Procedural variables | |||||||||||
| Procedure time (minutes) | 45 26 | 44 23 | 47 23 | 0.70 | |||||||
| Fluoroscopy time | 22 13 | 22 13 | 22 13 | 0.48 | |||||||
| (minutes) | |||||||||||
| Approach | |||||||||||
| Transfemoral | 77 | (97%) | 38 | (95%) | 39 | (100%) | |||||
| Trans-subclavian | 2 | (3%) | 2 | (5%) | 0 | ||||||
| Device | |||||||||||
| CoreValve Revalving | 35 | (44%) | 23 | (56%) | 12 | (31%) | |||||
| system 26-mm | |||||||||||
| CoreValve Revalving | 44 | (56%) | 17 | (43%) | 27 | (69%) | |||||
| system 29-mm | |||||||||||
| Procedural success | 74 | (94%) | 38 | (95%) | 36 | (92%) | 0.49 | ||||
| Postdilation | 4 | (5%) | 1 | (3%) | 3 | (8%) | 0.30 | ||||
| Valve-on-valve | 3 | (4%) | 2 | (5%) | 1 | (3%) | 0.51 | ||||
| Valve-in-valve | 0 | 0 | 0 | — | |||||||
