Initial aortic repair versus medical therapy for early uncomplicated type B dissections

Jyh Shinn Teh; Jui-Hsiang Chen; Ying-Ting Kuo; Chun-Yang Huang; Tai-Wei Chen; Chun-Che Shih; Chiao-Po Hsu

doi:10.1371/journal.pone.0319561

. 2025 Mar 20;20(3):e0319561. doi: 10.1371/journal.pone.0319561

Initial aortic repair versus medical therapy for early uncomplicated type B dissections

Jyh Shinn Teh ^1,², Jui-Hsiang Chen ^1,², Ying-Ting Kuo ³, Chun-Yang Huang ^1,², Tai-Wei Chen ^1,², Chun-Che Shih ⁴, Chiao-Po Hsu ^1,^2,^5,^*

Editor: Eyüp Serhat Çalık⁶

PMCID: PMC11957770 PMID: 40111982

Abstract

Background

Uncomplicated type B aortic dissections was regarded benign and treated with optimal medical therapy (OMT). However, studies showed highly unpredictable of disease progression, which suggested the need of earlier intervention. To search for features associated with worse outcomes with OMT is important due to risk of intervention. We investigated mortality and aortic remodeling between aggressive (OMT and pre-emptive endovascular intervention) and conservative therapy (OMT and necessary operations).

Methods

Retrospective analysis was performed in acute and subacute uncomplicated type B dissections patients, including typical aortic dissection, intramural hematoma and penetrating atherosclerotic ulcer, diagnosed between June 2005 and May 2021. Patients with Marfan, traumatic, iatrogenic, zone 0 (ascending aorta) involvement, and maximal aortic diameter > 45mm were excluded. Patients are classified according to initial management.

Results

77 and 33 patients in the aggressive and conservative groups were included respectively. There was no differences in baseline clinical and radiological characteristics between them. During mid-term follow-up (median 62.5 months), there was no difference in the mortality but the incidence of 30-day acute kidney injury was significantly higher in aggressive group. Positive aortic remodeling was noted in aggressive group, with development to complete or incomplete false lumen thrombosis (p < 0.01).

Conclusion

Aggressive pre-emptive endovascular therapy though has acceptable outcomes and positive aortic remodelling in early uncomplicated type B dissection with maximal aortic diameter ≤ 45mm. However, it could not translate into better mid-term survival than conservative therapy, but with higher risk of 30-day acute kidney injury. Aggressive pre-emptive endovascular intervention should be cautious in these patients.

Introduction

Acute aortic syndromes encompass a spectrum of three interrelated life-threatening aortic disease, including typical aortic dissection (TAD), intramural hematoma (IMH) and penetrating atherosclerotic ulcer (PAU). Although pathophysiologic mechanism and evolution differ among these entities, current guidelines suggested similar management strategy in line with management of TAD.[1, 2] Stanford classification system was widely adopted in current practice, which ascending aorta is involved in type A, spared in type B. The wait-and watch strategy with optimal medical therapy (OMT) was suggested for type B aortic syndromes, and surgical interventions with open or endovascular repair (TEVAR) was only considered for complicated cases. However, long-term outcomes of the diseases remain sobering due to aneurysmal expansion of false lumen and other late aortic complications with OMT.[3, 4] Furthermore, the disease progression of acute uncomplicated type B IMH (TBIMH) and PAU (TBPAU) is highly unpredictable, varying from complete absorption, conversion to classic aortic dissection to abrupt aortic rupture.[5, 6]

The INSTEAD (Investigation of STEnt grafts in Acute Dissection) and INSTEAD-XL trial demonstrated reduction of aortic-related mortality and delayed disease progression at 5 years, with pre-emptive TEVAR in 15-day to one-year uncomplicated type B typical aortic dissection (TBTAD).[7, 8] ADSORB trial also tells us pre-emptive TEVAR makes favorable aortic remodeling in one year for acute (≤14 days) uncomplicated TBTAD.[9] In acute uncomplicated TBIMH, Mesar et al, reported IMH thickness > 8mm was an independent risk factor to predictor medical therapy failure and need for endovascular repair,[5] and pre-emptive TEVAR may improve aortic-related adverse events, aortic related mortality and aortic remodeling in patients with high-risk features, such as focal intimal disruption, maximum aortic diameter ( ≥ 40–45mm) and hematoma thickness ( ≥ 10mm).[10] Some practitioners have advocated more aggressive treatment with pre-emptive TEVAR.

Due to inherent risk of morbidity and mortality, to search for features that predict worse outcomes with OMT is important for pre-emptive TEVAR. In this study, we aimed to clarify the need to shift toward more aggressive therapeutic approach in uncomplicated type B aortic syndromes with maximal aortic diameter ≤ 45mm.

Methods

Study population

This retrospective study was approved by the Institutional Review Board of the Taipei Veterans General Hospital (approval number: 2022-02-011CC). Informed written consent to access medical records was obtained from each patient. Selection criteria were patients with acute ( ≤ 14 days) and subacute (15 to 90 days) uncomplicated type B aortic syndromes, including TAD, and atypical dissection (IMH and PAU), according to SVS/STS classification scheme,[1] and those who received conservative therapy (OMT and necessary TEVAR) or aggressive therapy (OMT and pre-emptive TEVAR) in Taipei Veterans General Hospital from June 2005 to May 2021. Diagnosis of the diseases was established with computed tomography angiography (CTA) examination upon admission. Patients with Marfan syndrome, traumatic or iatrogenic dissections (including during cardiac operation or catheterization) were excluded. Furthermore, the composition is heterogeneous between two groups, to maximize the validity of the comparison, maximal aortic diameter > 45mm were also excluded in the study. Dissections that involved zone 0 were also excluded due to high uncertainty, as they were regarded as type A dissection in the Stanford classification. Patients are classified according to initial management (conservative or aggressive).

Outcomes

The clinical follow-up data were collected from records of hospitalization and scheduled monthly clinic evaluations or through direct telephone contact for all-cause (aortic or non-aortic reasons) mortality and major complications, which included all-cause death, cerebral ischemia, spinal cord ischemia, myocardial infarction and aortic rupture. Aorta-related mortality was defined as death from aortic rupture, malperfusion, or aortic dissection, confirmed by sonography or CTA examination.

Clinical examinations and imaging follow-up were performed basically at 1, 3, 6 and 12 months and then annually. Examinations were adjusted in patients with disease progression. Aortic remodeling was assessed with measurement of maximum false and true lumen diameter, hematoma thickness and maximum aortic diameter, as well as thrombosis of false lumen. For follow-up and outcome assessment, a comprehensive, systematic, cross sectional telephone survey was conducted at the endpoint of June 2022.

Statistical analysis

Data were processed with the SPSS/PC software package version 28. Continuous variables were presented as median (IQR) and compared with (non-parametric statistical) Mann-Whitney U test, while categorical data were compared with Fisher’s exact test. Overall survival between two groups was estimated by Kaplan-Meier survival analysis with log-rank test. All tests were 2 tailed, and P < 0.05 was considered statistically significant.

Results

A total of 110 patients were selected from patients with uncomplicated type B aortic syndromes, in acute and subacute setting, in our hospital between June 2005 and May 2021, with follow-up for 62.5 (34.2-101.6) months. (Fig 1) 77 patients received aggressive therapy and the other 33 patients received conservative therapy. The demographic characteristics of all patients are summarized in Table 1, there was no significant differences in clinical and radiographic variables. High risk features of dissection [1] were also compared between them and show no differences (S1 Table).

Table 1. Baseline characteristics by initial management in uncomplicated type B aortic syndrome.

	Aggressive (N = 77)	Conservative (N = 33)	P value
Clinical characteristics
Age (y)	61.0 (51.5– 71.5)	64.0 (56.5– 78.5)	0.255
Male	53 (68.8%)	22 (66.7%)	0.823
Hypertension	56 (72.7%)	26 (78.8%)	0.504
DM	8 (10.4%)	2 (6.1%)	0.720
Hyperlipidemia	2 (2.6%)	1 (3.0%)	1
Smoking	30 (39%)	9 (27.2%)	0.148
Cerebrovascular disease	4 (5.2%)	0	0.314
Coronary artery disease	8 (10.4%)	5 (15.2%)	0.525
Pulmonary disease	6 (7.8%)	2 (6.0%)	1
Previous aortic surgery	2 (2.6%)	1 (3.0%)	1
Uremia	3 (3.9%)	1 (3.0%)	1
eGFR (mL/min/1.73m²)^a	68.2 (54.4– 93.9)	67 (47.8– 75.2)	0.173
Creatinine (mg/dL)^a	1.03 (0.76– 1.26)	1.08 (0.88– 1.32)	0.210
Typical/Atypical dissection	42/35	15/18	0.382
Acute/Subacute dissection	64/13	29/4	0.774
Number of high-risk dissections	44 (57.1%)	13 (39.4%)	0.1
Radiographic characteristics
Thoracic aortic diameter (mm)	36.8 (33.5– 39.2)	36.3 (33.4– 40.9)	0.562
Abdominal aortic diameter (mm)	29.2 (26.9– 32.5)	28.5 (27.4– 34.3)	0.809
Maximal aortic diameter (mm) Maximal false lumen diameter^b (mm)	37.9 (35.0– 40.0) 20 (15.93– 24.73)	35.6 (33.4– 39.2) 18.2 (13.70– 23.2)	0.212 0.601
Hematoma or ulceration thickness^c (mm)	9.9 (7.5‒ 12)	8.75 (6.80‒ 10.6)	0.053
Proximal dissection level			0.147
Zone 1	3 (3.9%)	1 (3.0%)
Zone 2	13 (16.9%)	2 (6.1%)
Zone 3	59 (76.6%)	27 (81.8%)
Zone 4	2 (2.6%)	1 (3.0%)
Zone 5	0	2 (6.1%)

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Pulmonary disease: Chronic obstructive pulmonary disease and/or asthma

^acalculated with MDRD equation and excluded uremic patients;

^bonly typical dissection;

^conly atypical dissection.

Procedural details were summarized in S2 Table In the conservative group, the reason of intervention is progressive aneurysm formation. In terms of early outcomes (Table 2), there was no difference in mortality and major complications (cerebral ischemia, spinal cord ischemia, myocardial infarction, and aortic rupture) in both groups, however, aggressive group has significantly longer intensive care unit and hospital stays. The aggressive therapy had higher rate of acute kidney injury (AKI) (16.9% vs. 0%, p = 0.009) than the conservative therapy. 9 patients in the aggressive group had early post-operative endoleak, with 2 patients required re-intervention in one month. Subgroup analysis (TBTAD and atypical TBIMH & TBPAU) did not show unexpected findings (S3 Table and S4).

Table 2. Outcomes by initial management in uncomplicated Type B aortic syndrome.

	Aggressive (N = 77)	Conservative (N = 33)	P value
Early outcomes (≦30 days)
Mortality	1 (1.3%)	0	1
Aortic rupture	1 (1.3%)	0	1
Acute myocardial infarction	0	0
Neurological event	6 (7.8%)	0	0.176
Cerebral ischemia	4 (5.2%)	0	0.314
Spinal cord	2 (2.6%)	0	1
Major complications	6 (7.8%)	0	0.176
Retrograde type A dissection	1 (1.3%)		1
Acute kidney injury^a	13 (16.9%)	0	0.009
Post stent-grafting ischemic limb	1 (1.3%)	X
Post stent-grafting GI bleeding	1 (1.3%)	X
Post stent-grafting pneumonia	4 (5.2%)	X
Post stent-grafting respiratory failure	2 (2.6%)	X
Endoleak	9 (11.7%)	X
Type 1b	1 (1.3%)
Type 2	7 (9.1%)
Type 3	1 (1.3%)
Re-intervention	2 (2.6%)	X
Intensive care unit stay	4 (1.5–6)	2 (0–3)	<0.001
Hospital stay	16 (11–24.5)	9 (6.5–13.5)	<0.001
Cumulative midterm outcomes
All-Cause Mortality	23 (29.9%)	12 (36.4%)	0.503
Aorta-related Mortality	1 (1.3%)	0	1
Retrograde Type A dissection	2 (2.6%)	0	1
Endoleak	15 (19.5%)	1 (3.0%)	0.066
Type 1	3 (3.9%)	0
Type 2	11 (13.0%)	0
Type 3	2 (2.6%)	1 (3.0%)
Re-intervention	17 (22.1%)	2 (6.1%)	0.042
FL thrombosis within 3 year^b	N = 38	N = 14	<0.001
None/ Incomplete/ Complete	0/19 (50%)/19 (50%)	7 (50%)/4 (28.6%)/ 3 (21.4%)

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Major complication: Cerebral ischemia, spinal cord ischemia, myocardial infarction, and aortic rupture.

^aincrease in serum creatinine of ≧ 0.5 mg/dL or increase to ≧ 150% from baseline.

^bonly typical dissection

During longer follow-up, there was no significant differences in all-cause or aorta-related mortality between the two groups, but no doubt more patients with endoleak which may need re-intervention in aggressive therapy. Kaplan-Meier survival analysis revealed similar survival rate between two groups (Fig 2). Subgroup analysis showed similar results (S3 Table and S4).

Morphological evolution of aorta over time in uncomplicated TBTAD patients was summarized in Table 3. Positive aortic remodeling was found in the aggressive group, but not in conservative group. The maximal false lumen diameter and maximum aortic diameter significantly shrank at 3 months, 1 year and 3 year post stent-grafting. True lumen diameter increased and false lumen diameter decreased at level of or above celiac trunk post stent-grafting (p < 0.005). Aggressive treatment demonstrated significant accelerating false lumen thrombosis within 3-year follow-up (p < 0.01 in Table 2). On the contrary, TBIMH showed positive aortic remodeling over time no matter what aggressive or conservative, and without statistical difference between both groups (Table 4).

Table 3. Aortic remodeling by initial management in uncomplicated typical type B aortic dissection.

(Unit: mm)	Aggressive	Conservative	P value
Baseline	N=38	N=13
Maximum aortic diameter	38 (34.75– 40.68)	35.4 (32.40– 38.50)	0.121
Maximum FL diameter	20 (15.93– 24.73)	18.2 (13.70– 23.20)	0.337
TL diameter at LSCA level	18.7 (15.85– 22.75)	17.2 (10.75– 25.65)	0.795
FL diameter at LSCA level	16.9 (14.65– 21.80)	19.2 (14.00– 24.55)	0.525
TL diameter at hiatus level	15.3 (12.50– 20.28)	16.7 (13.90– 24.45)	0.266
FL diameter at hiatus level	16.2 (12.85– 20.85)	13.7 (10.30– 17.10)	0.302
TL diameter at celiac trunk level	13.9 (11.15– 19.88)	16.4 (12.70– 20.30)	0.234
FL diameter at celiac trunk level	13.6 (11.10– 18.40)	14.0 (10.70– 17.80)	0.588
TL diameter at renal artery level	14.45 (11.68– 18.53)	12.2 (8.93– 20.90)	0.427
FL diameter at renal artery level	9.5 (6.53– 14.33)	13.7 (10.48– 16.33)	0.123
3-month remodeling	N=38	N=12
Maximum aortic diameter	‒3.2 (‒5.4– +0.13)^c	+1.8 (‒2.23– +2.85)	0.012
Maximum FL diameter	‒6.2 (‒11.73– ‒2.88)^c	0 (‒3.08– +3.78)	< 0.001
TL diameter at LSCA level	+11.3 (+6.08– +14.55)^c	+1.5 (‒1.30– +6.15)	< 0.001
FL diameter at LSCA level	‒15.7 (‒18.5– ‒9.23)^c	‒0.1 (‒9.55– +2.53)	< 0.001
TL diameter at hiatus level	+7 (+3.70– +10.75)^c	‒0.5 (‒3.68– +5.85)	0.001
FL diameter at hiatus level	‒10.15 (‒16.05– 0)^c	+1.2 (‒3.30– +8.38)	0.004
TL diameter at celiac trunk level	+3.2 (+0.65– +10.43)^c	+0.8 (‒1.73– +3.90)	0.022
FL diameter at celiac trunk level	‒1.9 (‒8.4– +0.03)^c	+0.7 (‒3.5– +7.28)	0.021
TL diameter at renal artery level	+1.9 (‒0.40– +3.60)	‒0.6 (‒4.50– +2.40)	0.122
FL diameter at renal artery level	0 (‒2.93– +2.08)	0 (‒1.30– +1.20)	0.913
1-Year remodeling	N=32	N=10
Maximum aortic diameter	‒2.8 (‒6.40– ‒0.20)^c	+2.1 (‒1.90– +7.98)	0.007
Maximum FL diameter	‒8.1 (‒12.23– ‒2.40)^c	+0.5 (‒2.98– +4.45)	0.008
TL diameter at LSCA level	+10.9 (+7.3– +16.18)^c	+3.05 (+1.20– +7.80)	< 0.001
FL diameter at LSCA level	‒16.4 (‒19.40– ‒12.0)^c	‒1.95 (‒11.28– +2.00)	< 0.001
TL diameter at hiatus level	+6.4 (+3.45– +12.80)^c	‒0.5 (‒4.33– +6.95)	0.012
FL diameter at hiatus level	‒10.5 (‒17.15– ‒2.1)^c	+3.95 (‒7.43– +10.75)	0.004
TL diameter at celiac trunk level	+ 5.2 (+1.0– +9.53)^c	+0.2 (‒2.75– +1.60)	0.004
FL diameter at celiac trunk level	‒1.5 (‒9.38– +0.78)^c	+0.3 (‒2.43– + 7.18)	0.053
TL diameter at renal artery level	+1.4 (‒1.23– +4.70)	+1.3 (‒0.58– +4.88)	0.953
FL diameter at renal artery level	0 (‒4.35– +2.48)^a	0 (‒0.43– +1.53)	0.687
3-Year remodeling	N=30	N=9
Maximum aortic diameter	‒2.2 (‒6.85– +0.35)^c	+2.3 (‒0.1– +6.45)	0.006
Maximum FL diameter	‒7.55 (‒12.35– ‒3.85)^c	+0.5 (‒5.25– +5.30)	0.008
TL diameter at LSCA level	+11.25 (+6.58– +16.35)^c	+6.8 (+1.65– +14.85)	0.211
FL diameter at LSCA level	‒16.35 (‒20.13– ‒11.75)^c	‒12.9 (‒15.20– ‒4.60)	0.014
TL diameter at hiatus level	+6.3 (+3.15– +10.65)^c	+4.8 (‒1.50– +8.90)	0.424
FL diameter at hiatus level	‒8.7 (‒18.20– 0)^c	‒2.4 (‒12.95– +10.0)	0.142
TL diameter at celiac trunk level	+6.0 (+1.30– +11.48)^c	+1.9 (‒0.45– +2.95)	0.014
FL diameter at celiac trunk level	‒3.5 (‒13.05– +0.55)^c	+2.8 (+0.3– +8.15)	0.015
TL diameter at renal artery level	+2.0 (-0.45– +3.58)	+0.9 (-3.6– +3.15)	0.301
FL diameter at renal artery level	0 (‒2.68– +5.35)	0 (‒0.35– +1.60)	0.853

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FL: false lumen; LSCA: left subclavian artery; TL: true lumen

^ap < 0.05;

^bp < 0.01;

^cp < 0.005 vs. baseline within group.

Table 4. Aortic remodeling by initial management in uncomplicated Type B IMH.

(unit: mm)	Aggressive	Conservative	P value
Baseline	N = 29	N = 16
Maximum aortic diameter	37.05 (35.73‒ 39.60)	37.4 (34.60‒ 39.75)	0.785
Maximum hematoma thickness	10 (7.73‒ 12.08)	8.75 (6.20‒ 11.40)	0.162
3-month remodeling	N = 25	N = 8
Maximum aortic diameter	‒4.45 (‒6.88‒ ‒2.65)^c	‒7.05 (‒9.98‒ ‒1.75)^a	0.396
Maximum hematoma thickness	‒5.7 (‒8.70‒ ‒2.15)^c	‒4.9 (‒8.38‒ ‒0.53)	0.557
1-year remodeling	N = 20	N = 9
Maximum aortic diameter	‒4.9 (‒1.50‒ ‒6.43)^c	‒6.6 (‒9.05‒ ‒2.15)	0.289
Maximum hematoma thickness	‒7.35 (‒10.20‒ ‒4.68)^c	‒4 (‒8.15‒ ‒1.85)	0.045
3‒year remodeling	N = 18	N = 7
Maximum aortic diameter	‒4.1 (‒5.98‒ ‒2.85)^c	‒3.8 (‒8.90‒ ‒2.50)^b	0.856
Maximum hematoma thickness	‒7.9 (‒12.18‒ ‒4.78)^c	‒4.9 (‒9.10‒ ‒2.90)^c	0.318

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^ap < 0.05;

^bp < 0.01;

^cp < 0.005 vs. baseline within group.

Discussion

In our study, aggressive treatment with early pre-emptive TEVAR failed to demonstrate any survival benefits. However, a higher risk of AKI was identified in patients with a maximum aortic diameter of ≤ 45 mm over a 10-year follow-up period. Pre-emptive TEVAR promoted positive aortic remodeling, evidenced by a reduction in maximum aortic diameter and/or false lumen diameter in type B aortic dissections. However, the positive aortic remodeling did not translate into improved survival outcomes for this group of patients.

Medical therapy is widely accepted as the first-line treatment, and it is a class 1 recommendation for acute uncomplicated type B aortic syndromes.[2,11,12] However, long-term survival rates continue to be poor.[3] Data from the International Registry of Acute Aortic Dissection (IRAD) have indicated that the short-term outcomes of medical treatment are excellent, whereas the long-term outcomes are poor, with reports of aneurysmal degeneration affecting up to 60% of patients and high follow-up mortality, approaching one in every four patients at 3 years.[3] Several studies have also reported high OMT failure rates in TBIMH cases, with progression to typical aortic dissection, aneurysm formation, and increased hematoma size.[5,13]

ADSORB and INSTEAD, two randomized control trials involving patients with acute (1–14 days) and subacute to chronic (15 days to 1 year) uncomplicated TBTAD, respectively, were not sufficiently powered to demonstrate clinical benefits in terms of short-term (2-year) mortality; however, improvements in aorta-related mortality and disease progression at 5 years were identified in patients randomized to TEVAR.[7–9] Similar results were reported in other studies.[14, 15] Because of the risks associated with performing a procedure on the vulnerable diseased aorta of asymptomatic patients, pre-emptive TEVAR currently classified as a class 2a or 2b recommendation for acute uncomplicated type B aortic syndromes.[2,11,12]

Therefore, identifying individuals who would benefit from pre-emptive TEVAR might be more helpful. IRAD data and other studies have suggested that long-term adverse events or mortality associated with uncomplicated type B aortic dissections can be predicted by various risk factors, such as maximum aortic diameter, hematoma thickness, false lumen flow, and presence of connective tissue disease.[5,16–19] By targeting these high-risk features, pre-emptive TEVAR could improve survival as early as the first year.[20, 21] Therefore, the “wait and watch” strategy with OMT is not necessarily the optimal or most appropriate care policy for early uncomplicated type B aortic syndrome, and treatment decisions should be based on high-risk factors for mortality or adverse events during follow-up.[10] In our study, we adopted a reverse approach by excluding patients with a maximum aortic diameter of > 45mm or Marfan syndrome and following up on these patients. This is because various other risk factors can directly or indirectly affect the aortic diameter. This suggests that the aortic diameter is the central or final marker for these risk factors in determining outcomes. Our study results indicated that pre-emptive TEVAR did not improve clinical benefits even with a follow-up period of 10 years. Furthermore, the 3-year survival exceeded 80% in both groups, which is higher than that reported by Tsai et al.[3] This also suggests that the survival rate is higher for patients with a maximum aortic diameter of ≤ 45mm than for those with a diameter of > 45mm. (S1 Fig). Overall, these findings provide us with valuable insights for clinical practice.

Sailer et al reported a high risk (approximately 25%) of adverse event in the first year after TBIMH onset, with the risk stabilizing during subsequent follow-ups. By contrast, the risk of an adverse event in the first year is approximately 15% for patients with TBTAD and remains consistent in subsequent years.[22] This suggests that the risk of adverse events may differ between TBTAD, TBIMH, and TBPAU. However, no significant difference between these pathologies was identified in our study.

The second issue is the timing of pre-emptive TEVAR. The median time for the aggressive group was 15 days, extending beyond the acute stage in our study. This delay is based on the concept that the intima of the dissected aorta is highly fragile during the acute stage. Numerous studies have suggested that performing TEVAR in the subacute stage yields more favorable results, and more complications, particularly aortic rupture, retrograde type A dissection, and stroke, have been reported in cases of TEVAR conducted during the acute phase (<15 days).[20,23,24]

The 30-day mortality appears to be better in our study than in previous ones (0 in the OMT group and 1.3% in the TEVAR group of our study vs. 1.5% in the OMT group and 2.8% in the TEVAR group of the INSTEAD trial and 7.6% in the medical group and 8.7% in the TEVAR group in a recently published meta-analysis by Wang et al.).[7,25] However, if patients with Marfan syndrome and a larger aortic diameter (maximum aortic diameter > 45 mm) were included, 30-day mortality would increase to more than 2%. This indirectly supports the hypothesis that the maximum aortic diameter is a significant factor influencing early mortality.[26] However, 30-day complication rate in our study is only generally consistent with those reported in previous studies, without being significantly lower.[7,24] This may be attributed to the inherent risks of TEVAR, even in patients with smaller maximum aortic diameters. Post-operative AKI was significantly higher in the aggressive group in our cohort. The incidence of AKI, which is seldom emphasized, was significantly higher (16.9%) in patients undergoing TEVAR.[27] This complication can be attributed to the use of contrast during stent-graft deployment, which places patients at risk for AKI.

In addition to the higher risk of AKI and stent-graft-related endoleak, longer ICU and hospital stays contribute to increased health-care expenditure associated with hospitalization and the increasing number of invasive procedures. Although we did not assess the cost-effectiveness of these two therapeutic options, from the viewpoint of clinical outcomes, pre-emptive TEVAR may not be an appropriate option for these patients.

Positive aortic remodeling in TBTAD was identified in the aggressive group, with decreases in both the maximum false lumen diameter and the total aortic diameter during the follow-up periods at 3 months, 1 year, and 3 years after stent-grafting. The present study confirmed previous findings that aortic remodeling and false lumen thrombosis after TEVAR is a continuous process with greater remodeling in proximal aortic segments.[8, 9] The VIRTUE registry revealed that most of the aortic remodeling process was complete at 1 year, whereas false-lumen thrombosis rates continued to increase over the course of 3 years.[28] The results for aortic remodeling in the TBIMH did not indicate any obvious beneficial effect in the aggressive group compared with the conservative group. The lack of significance may be associated with the smaller wall stress in patients with smaller aortic diameters, which may facilitate positive aortic remodeling even without TEVAR. Other studies have reported similar observations.[19,29]

Our study demonstrated that OMT is sufficient for patients with acute and subacute uncomplicated type B aortic syndrome with a maximum aortic diameter of ≤ 45 mm, and no significant difference in outcomes after intervention was identified between TBTAD and IMH. Thus, more randomized control studies are warranted to confirm the nonsignificant effects of pre-emptive TEVAR in these patients in the future.

Conclusion

Aggressive therapy with pre-emptive TEVAR produced acceptable outcomes. However, compared with conservative therapy (OMT), TEVAR did not translate into a survival benefit based on positive aortic remodeling in patients with acute and subacute uncomplicated type B aortic dissection and a maximum aortic diameter of ≤ 45 mm. Although the incidence of major complications, including paraplegia, stroke, and retrograde type A dissection, was low, the 20% incidence of AKI following TEVAR warrants increased attention. Pre-emptive TEVAR should be approached with caution in these patients.

Limitation of study

There are several limitations of this study. This was a retrospective study during a span of fifteen years, which leads to heterogeneity in various aspects, including management strategy and surgical techniques. Only 30% patients were followed up more than 10 years. Selection bias is possible as the patient grouping was not randomised. Sample size in our study was relatively small and subgroup analysis between acute and subacute disease was not performed in our study. Besides that, optimal therapeutic efficacy of OMT was failed to assess as unavailable information of medication adherence in each patient and exact cause of some mortalities cannot be acquired merely by telephone survey.

Supporting information

S1. Table. High risk features by initial management in uncomplicated type B aortic syndrome.

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S2 Table. Procedural characteristics by initial management in uncomplicated type B aortic syndrome.

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pone.0319561.s002.docx^{(27.2KB, docx)}

S3 Table. Outcomes by initial management in uncomplicated typical type B aortic dissection.

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pone.0319561.s003.docx^{(28.1KB, docx)}

S4 Table. Outcomes by initial management in uncomplicated atypical type B aortic dissection.

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pone.0319561.s004.docx^{(28KB, docx)}

S1 Fig. KM Plot of aggressive group (Excluded cases (Marfan, Maximum aortic diameter > 45mm patient) vs included cases).

(TIF)

pone.0319561.s005.tif^{(635.9KB, tif)}

S1 Data. Pre-TEVAR baseline characteristic of patients.

(XLSX)

pone.0319561.s006.xlsx^{(29.5KB, xlsx)}

S2 Data. Procedural details, early and late outcome.

(XLSX)

pone.0319561.s007.xlsx^{(182KB, xlsx)}

Data Availability

All relevant data are within the article and its Supporting Information files.

Funding Statement

The author(s) received no specific funding for this work.

References

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PLoS One. 2025 Mar 20;20(3):e0319561. doi: 10.1371/journal.pone.0319561.r001

Author response to Decision Letter 0

9 Jul 2023

PLoS One. doi: 10.1371/journal.pone.0319561.r002

Decision Letter 0

Eyüp Serhat Çalık

29 Aug 2024

PONE-D-23-19689Initial aortic repair versus medical therapy for early uncomplicated type B dissectionsPLOS ONE

Dear Dr. Hsu,

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Additional Editor Comments:

Dear Authors

Optimal medical treatment of uncomplicated Type B aortic dissections has been considered the classical approach, but with the widespread use of TEVAR, immediate interventional or hybrid treatment approaches have become more common. Demonstrating the advantages and disadvantages of these two approaches makes your manuscript important. The manuscript has been evaluated by two reviewers and their recommendations are as follows. I would especially like to emphasize the revision of your statistical methods and language editing. Good luck.

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Reviewer #1: No

Reviewer #2: Partly

**********

2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: No

Reviewer #2: No

**********

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Reviewer #1: Yes

Reviewer #2: Yes

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Reviewer #1: With interest, I have read a paper by Jyh Shinn Teh and associates devoted to a topical problem of choosing between medical and interventional treatment of early uncomplicated type B aortic dissection.

There is a big amount of data concerning the recommendation of medical therapy as preferable treatment in early acute uncomplicated Stanford type B aortic dissection. At the same time, some research studies suggest early aggressive approach in treatment of such patients, mostly in the form of transcatheter intervention. The authors performed retrospective comparative analysis of results in patients with acute and subacute uncomplicated type B typical aortic dissection, intramural hematoma and penetrating atherosclerotic aortic ulcer, who received medical and interventional treatment. I would recommend shrinking the Introduction section, and moving the information from it to the Discussion section. The purpose of the study has not been defined. No data about amount of patients with retrograde aortic dissection is provided. A significantly higher proportion of patients with signs of unfavourable prognosis in the interventional treatment group is noteworthy. This may have influenced the results obtained. To offset this effect, I would recommend averaging the patients according to the presence or absence of signs of unfavourable prognosis, all together or individually (maximum aortic diameter 22 mm or more, pleural effusion, refractory hypertension, etc.). I would also recommend excluding patients with Marfan syndrome from the analysis, as there are few of them (3 in each group) and removing them would allow for more "clean" groups and more reliable results. In addition, there is a question of whether transcatheter interventions in patients with Marfan syndrome and acute aortic syndrome are consistent with the recommendation to prefer open surgery in these patients. The question arises as to why the median time from the onset of dissection to surgery in the intervention group was 16 days (from 9 to 26 days) and how correct it is in this situation to talk about treating acute dissection. I would like to know what were the indications for total arch prosthetics under CPB and if the frozen or conventional elephant trunk technique was used. The conclusion of the worst results of aggressive treatment with early TEVAR is based on the incorrect comparison of two different groups. I would recommend performing “cleaning” and averaging of the study groups as mentioned above. To maximize the validity of the comparison, I would recommend that the authors discuss the possibility of performing a propensity score matching. The absence of differences between the results of different types of treatment indicates a correct selection of patients for medical, interventional and open surgical treatment, and the authors' task is to statistically process the data in such a way as to offset the effects of heterogeneous composition of the groups.

I recommend performing English proofreading and major revision.

Reviewer #2: 1. To be distribution-free and no need to account for normal distribution, please use non-parametric statistical methods for all analyses (your sample sizes were also not large), i.e. median+-IQR, Mann-Whitney U test (not t-test), and Fisher's exact test.

2. The presented tables are too complicated and please consolidate, for example, Tables 6 and 7. There were too many measurements. Possible to simplify them and just show aortic remodeling % or Yes/No?

3. Plos ONE is a general-purpose journal, not a cardiovascular or aortic surgery journal. Please rewrite the whole manuscript to make it more reader-friendly to non-specialist audience. For example, please define "aortic remodeling" and explain its relationships to all your measurements in Tables 6 and 7.

4. Please define "survival" or "mortality". Hospital survival? Overall survival? 30-day survival? Hospital mortality? All-cause mortality? Aorta-related mortality? Surgical mortality? 30-day mortality? Please define your hard and soft outcomes. Short-term? Long-term? How to define short- and long-term?

5. You said aggressive group had no survival advantage. Was it long-term, short-term, or overall? Then you said aortic remodeling in the aggressive group may translate into improved long-term survival. How and why? Were they contradicted viewpoints? Please explain with your data by a reader-friendly way.

6. An analog to your topic is "Initial CABG versus PTCA for early uncomplicated CAD-1VD". How do you think the data will show? CABG may show better long-term graft patency but was it worthy the surgical risks and would the patient/family accept it? Over-treatment may show superior efficacy but how about the risk, cost, or life-quality effect? Please discuss this kind of arguments in your discussion.

Simply put, non-parametric statistics, simply your tables, better definitions, discuss over-treatment, and rewrite for non-specialist readers.

**********

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Reviewer #1: Yes: Vladimir Uspenskiy

Reviewer #2: Yes: Robert J. Chen, MD, MPH

**********

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PLoS One. 2025 Mar 20;20(3):e0319561. doi: 10.1371/journal.pone.0319561.r003

Author response to Decision Letter 0

28 Oct 2024

PLOS ONE, EDITORIAL OFFICE

27 Oct 2024

Dear Reviewers or Editors,

The feedback provided by reviewers has been helpful to improving this manuscript and we are grateful for their input. We have also responded in detail to all the comments made in the following pages. This rebuttal follows the format in which the points from the reviewers were left in the original order, in blue, and our responses (in black) were then inserted after each of those points.

Reviewer #1

1. I would recommend shrinking the Introduction section, and moving the information from it to the Discussion section.

Authors: According to the reviewer’s suggestion, we have re-written the introduction and discussion sections.

2. The purpose of the study has not been defined.

Authors: We have added in last paragraph of Introduction. (Page 6, Line 102-104)

3. No data about amount of patients with retrograde aortic dissection is provided.

Authors: In Figure 1, 76 patients were excluded because of zone 0 involvement, and they were also known as retrograde aortic dissection cases (in the new reporting standards as B0,x).1

4. A significantly higher proportion of patients with signs of unfavourable prognosis in the interventional treatment group is noteworthy. This may have influenced the results obtained. To offset this effect, I would recommend averaging the patients according to the presence or absence of signs of unfavourable prognosis, all together or individually (maximum aortic diameter 22 mm or more, pleural effusion, refractory hypertension, etc.).

Authors: We would discuss how to manage this issue in answer to comment 9.

5. I would also recommend excluding patients with Marfan syndrome from the analysis, as there are few of them (3 in each group) and removing them would allow for more "clean" groups and more reliable results.

Authors: Marfan syndrome patients were excluded in revised version.

6. In addition, there is a question of whether transcatheter interventions in patients with Marfan syndrome and acute aortic syndrome are consistent with the recommendation to prefer open surgery in these patients.

Authors: Yes, transcatheter intervention was not recommended in Marfan patients. However, this is a retrospective study and some patients without typical characteristics were diagnosed with Marfan syndrome after operation by genetic test. It is not an issue in the revised manuscript as Marfan patients were excluded.

7. The question arises as to why the median time from the onset of dissection to surgery in the intervention group was 16 days (from 9 to 26 days) and how correct it is in this situation to talk about treating acute dissection.

Authors: We use “early” in the topic of this manuscript, which represented “acute and subacute” dissection. These patients are uncomplicated dissection cases and TEVAR could be done non-urgently, and beyond the acute phase. Furthermore, many studies suggested that performing TEVAR in subacute stage would be better. 2-4

8. I would like to know what were the indications for total arch prosthetics under CPB and if the frozen or conventional elephant trunk technique was used.

Authors: This is a retrospective study, and the indication of total arch replacement is not clearly mentioned in medical records. The decision to perform total arch replacement depends on surgeon in-charge, which usually associated with unhealthy aortic arch, arch anatomy or larger aortic arch diameter. Frozen elephant trunk was used in all total arch replacement cases of this study.

9. The conclusion of the worst results of aggressive treatment with early TEVAR is based on the incorrect comparison of two different groups. I would recommend performing “cleaning” and averaging of the study groups as mentioned above. To maximize the validity of the comparison, I would recommend that the authors discuss the possibility of performing a propensity score matching. The absence of differences between the results of different types of treatment indicates a correct selection of patients for medical, interventional and open surgical treatment, and the authors' task is to statistically process the data in such a way as to offset the effects of heterogeneous composition of the groups.

Authors: We tried to offset the effects of heterogeneous composition between these two groups. The association of survival and high-risk features were analyzed, and only “maximal aortic diameter” was strongly related to survival, and the others (ulceration thickness, radiographic malperfusion and IMH with ulcer-like projection) were not. Then distribution of the variable (maximal aortic diameter) was checked in two groups and found that more patients in the aggressive group had larger aortic diameters. Directly excluding patients whose maximal aortic diameter larger than 45mm can correct the pre-treatment difference of variables between the two groups without excluding too many cases (as performing Propensity Score Matching). Hence, we excluded patients with “maximal aortic diameter” larger than 45 mm in the revised manuscript.

10. I recommend performing English proofreading and major revision.

Authors: English proofreading was done.

Reviewer #2:

1. To be distribution-free and no need to account for normal distribution, please use non-parametric statistical methods for all analyses (your sample sizes were also not large), i.e. median+-IQR, Mann-Whitney U test (not t-test), and Fisher's exact test.

Answer: Statistical methods were corrected in the revised manuscript.

Answer: Most tables and measurements have been simplified. However, details of aortic remodeling were kept as it demonstrated effect of TEVAR over different segment of aorta.

Answer: Definition and evaluation of aortic remodeling was mentioned in the method section.

Answer: We have simplified measurements to 30-day, overall and aortic-related mortality. Definitions were mentioned in Method section. Outcomes were also simplified to short term (30 day) and mid-term (10 years), with major aorta related complications such as aorta rupture and aorta related mortality, procedural complications, neurological complications and else.

Answer: In the revised manuscript, we focused on patients whose maximum aortic diameter ≤ 45mm. However, in this specific group, aortic remodeling in the aggressive group could not translate into improved mid-term survival.

Answer: A short paragraph mentioned about cost-effectiveness was added in the discussion section of revised manuscript.

Reference:

1.Lombardi JV, Hughes GC, Appoo JJ, Bavaria JE, Beck AW, Cambria RP, Charlton-Ouw K, Eslami MH, Kim KM, Leshnower BG, Maldonado T, Reece TB and Wang GJ. Society for Vascular Surgery (SVS) and Society of Thoracic Surgeons (STS) Reporting Standards for Type B Aortic Dissections. The Annals of thoracic surgery. 2020;109:959-981.

2.Potter HA, Ding L, Han SM, Weaver FA, Beck AW, Malas MB and Magee GA. Impact of high-risk features and timing of repair for acute type B aortic dissections. Journal of vascular surgery. 2022;76:364-371.e3.

3.Jubouri M, Al-Tawil M, Yip HCA, Bashir A, Tan S, Bashir M, Anderson R, Bailey D, Nienaber CA, Coselli JS and Williams I. Mid- and long-term outcomes of thoracic endovascular aortic repair in acute and subacute uncomplicated type B aortic dissection. Journal of cardiac surgery. 2022;37:1328-1339.

4.Xie E, Yang F, Liu Y, Xue L, Fan R, Xie N, Chen L, Liu J and Luo J. Timing and Outcome of Endovascular Repair for Uncomplicated Type B Aortic Dissection. European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. 2021;61:788-797.

Attachment

Submitted filename: Responses to Reviewers.docx

pone.0319561.s009.docx^{(31.1KB, docx)}

PLoS One. doi: 10.1371/journal.pone.0319561.r004

Decision Letter 1

Eyüp Serhat Çalık

3 Dec 2024

PONE-D-23-19689R1Initial aortic repair versus medical therapy for early uncomplicated type B dissectionsPLOS ONE

Dear Dr. Hsu,

Please submit your revised manuscript by Jan 17 2025 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org . When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

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PLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #2: All comments have been addressed

Reviewer #3: (No Response)

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

Reviewer #2: Yes

Reviewer #3: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #2: Yes

Reviewer #3: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

Reviewer #2: Yes

Reviewer #3: No

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

Reviewer #2: Yes

Reviewer #3: Yes

**********

6. Review Comments to the Author

Reviewer #2: After carefully reviewing the revised manuscript and the authors' responses, I am pleased with the improvements made based on previous feedback. The authors effectively addressed critical points from my initial review, specifically the implementation of non-parametric statistical methods and the simplification of tables, which enhances the manuscript’s readability. Additionally, the clarification of complex terms, such as "aortic remodeling," and the distinctions between short- and long-term outcomes improve accessibility for the PLOS ONE readership. The nuanced discussion about aggressive management benefits, including aortic remodeling without survival benefits, is balanced and well-articulated. I commend the authors for thoroughly integrating these modifications, which significantly strengthen the clarity and relevance of the findings.

Reviewer #3: 1. If you exclude the maximum aortic diameter >45mm, you should discuss about these patients separately since these are the high risk patients.

2. Original conclusion is better than the revised conclusion. Revised conclusion sounds very negative.

3. I don't see the procedure details which is Table S2...

4. Some patients in both groups have zone 1,2 involvement. These are type A dissection, not type B. So I am not sure you should include these patients.

5. To be honest, I don't know what's new on this paper...

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean? ). If published, this will include your full peer review and any attached files.

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Reviewer #2: Yes: Robert J. Chen, MD, MPH

Reviewer #3: No

**********

PLoS One. 2025 Mar 20;20(3):e0319561. doi: 10.1371/journal.pone.0319561.r005

Author response to Decision Letter 1

21 Dec 2024

PLOS ONE, EDITORIAL OFFICE

15 Dec 2024

Dear Reviewers or Editors,

The feedback provided by reviewers has been helpful to improving this manuscript and we are grateful for their input. We have responded in detail to all the comments by reviewer #3 made in the following pages.

Reviewer #3:

1. If you exclude the maximum aortic diameter >45mm, you should discuss about these patients separately since these are the high risk patients.

Figure 1: KM Plot of excluded cases (Marfan, Maximum aortic diameter > 45mm patient) vs. included cases

Figure 2: KM Plot of aggressive group (Excluded cases vs included cases)

From Figure 1 and 2, patient with Marfan syndrome and maximum aortic diameter > 45mm had worse survival outcome than included cases, with statistically significant. This indirectly supports the hypothesis that the maximum aortic diameter is a significant factor influencing early mortality.

There were 3 cases (7.9%) with Marfan or maximum aortic diameter >45mm in the conservative group. On the contrary, there were 18 cases (18.4%) with Marfan or maximum aortic diameter >45mm in the aggressive group. Hence, if we did not exclude these patients, the power of comparison may be not enough. Furthermore, most patients whose maximum aortic diameter >45mm received pre-emptive TEVAR. In consideration of these factors, we excluded these cases in our study at last. The above Figure 2 was added in the discussion section of revised manuscript.

2. Original conclusion is better than the revised conclusion. Revised conclusion sounds very negative.

The revised conclusion is no survival benefits with aggressive treatment, but positive remodeling of aorta in type B patients with maximal aortic diameter ≤45mm. (Focused on the group maximal aortic diameter ≤45mm)

3. I don't see the procedure details which is Table S2...

Procedural details were showed in the Table S2, which could be downloaded via the link of supplemental tables in the page 40 of manuscript PDF file.

4. Some patients in both groups have zone 1,2 involvement. These are type A dissection, not type B. So I am not sure you should include these patients.

Although newer classification system of aortic dissection has been proposed,1 we used the SVS/STS classification scheme for aortic dissection proposed in 2020.2 In this classification, the arch involved (zone 1, 2) type B dissection was not regarded as type A. In our study, we used this classification scheme to collect patients and written in the method section.

5. To be honest, I don't know what's new on this paper

In our study, pre-emptive TEVAR promotes positive aortic remodeling in type B patients. However, no survival benefits were noted in patients with maximal aortic diameter ≤45mm compared with optimal medical control. Moreover, higher risk of 30-day acute kidney injury was noted after pre-emptive TEVAR. It hints that the decision should be more careful to balance the risk of TEVAR with the benefit of aortic remodeling only in this specific group of patients.

Reference:

1. Ramesh P, Al-Zubaidi FI, Abdelghaffar M, Babiker S, Aspinall A, Butt S, Sabry H, Zeinah M and Harky A. TEM Classification of Aortic Dissection-The Evolving Scoring System: A Literature Review. Heart, lung & circulation. 2024;33:17-22.

2. Lombardi JV, Hughes GC, Appoo JJ, Bavaria JE, Beck AW, Cambria RP, Charlton-Ouw K, Eslami MH, Kim KM, Leshnower BG, Maldonado T, Reece TB and Wang GJ. Society for Vascular Surgery (SVS) and Society of Thoracic Surgeons (STS) Reporting Standards for Type B Aortic Dissections. The Annals of thoracic surgery. 2020;109:959-981.

** For more details, please see Response to reviewers

PLoS One. doi: 10.1371/journal.pone.0319561.r006

Decision Letter 2

Eyüp Serhat Çalık

7 Jan 2025

PONE-D-23-19689R2Initial aortic repair versus medical therapy for early uncomplicated type B dissectionsPLOS ONE

Dear Dr. Hsu,

Please submit your revised manuscript by Feb 21 2025 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org . When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

We look forward to receiving your revised manuscript.

Kind regards,

Eyüp Serhat Çalık

Academic Editor

PLOS ONE

Journal Requirements:

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

Additional Editor Comments:

I would like to thank the authors for their appropriate revisions and point-by-point responses. Your manuscript has been reviewed by previous reviewers and here are some of their suggestions for minor corrections. Good luck.

Note: Please note the attached pages.

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

Reviewer #1: All comments have been addressed

Reviewer #2: All comments have been addressed

Reviewer #3: (No Response)

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

Reviewer #1: No

Reviewer #2: Yes

Reviewer #3: Yes

**********

6. Review Comments to the Author

Reviewer #1: The list of references used needs to be updated. Of the 32 papers used, 24 (75%) were published earlier than 2019 (more than 5 years ago), including 5 papers published in 2004 and earlier (20 or more years ago).

The text contains a number of typographical errors (e.g., on line 82) as well as some syntylic errors. I recommend performing English proofreading by a native speaker.

In general, the paper is technically sound, and the methods are appropriate and properly conducted. The results and conclusions logically follow from the conducted analysis. The data are adequately interpreted. The statistical analysis is sound. The claims are fully supported by the study data. There are no special ethical concerns regarding the use of human subjects. I have no other special comments on the work, and I recommend it for publication after minor revision.

Thank you for submitting your study to the Journal and good luck for the paper.

Reviewer #2: The authors have addressed the reviewer's comments thoroughly and thoughtfully. They provided additional analyses and clarifications to support their methodology and findings. The revised conclusion appropriately reflects the study's results, highlighting both the positive aortic remodeling and lack of survival benefits in the specific patient group. The manuscript's novelty lies in its focus on patients with maximal aortic diameter ≤45mm, offering valuable insights for clinical decision-making in this subset.

Reviewer #3: Still you didn't answer my question about Figure 1. Figure 1 is study flow diagram, but you mentioned Figure 1 is KM plot of excluded cases in the"Author's Response to Reviewer's Comments". I still need to see the outcome of excluded cases. Same as Figure 2 which you mentioned "KM plot of aggressive group" which I don't see...

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean? ). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy .

Reviewer #1: Yes: Vladimir Uspenskiy, MD, DrHabil, Associate Professor

Reviewer #2: Yes: Robert Jeenchen Chen, MD, MPH

Reviewer #3: No

**********

Attachment

Submitted filename: PONE-D-23-19689 _review 04 Jan 2025.docx

pone.0319561.s010.docx^{(16.3KB, docx)}

PLoS One. 2025 Mar 20;20(3):e0319561. doi: 10.1371/journal.pone.0319561.r007

Author response to Decision Letter 2

29 Jan 2025

1. Some of the references have been updated with relevant, which showed in the revised manuscript.

2. Both of the figures were attached in “ Response to Reviewers” instead of manuscript. We will redefined them as Figure 3 and Figure 4.

From Figure 3 and 4, patient with Marfan syndrome and maximum aortic diameter > 45mm had worse survival outcome than included cases, with statistically significant. This indirectly supports the hypothesis that the maximum aortic diameter is a significant factor influencing early mortality.

There were 3 cases (7.9%) with Marfan or maximum aortic diameter >45mm in the conservative group. On the contrary, there were 18 cases (18.4%) with Marfan or maximum aortic diameter >45mm in the aggressive group. Hence, if we did not exclude these patients, the power of comparison may be not enough. Furthermore, most patients whose maximum aortic diameter >45mm received pre-emptive TEVAR. In consideration of these factors, we excluded these cases in our study at last. The above Figure 4 was added in the discussion section of revised manuscript (showed as Figure S1)..

Attachment

Submitted filename: Response to reviewers 0115.docx

pone.0319561.s012.docx^{(7.7MB, docx)}

PLoS One. doi: 10.1371/journal.pone.0319561.r008

Decision Letter 3

Eyüp Serhat Çalık

5 Feb 2025

Initial aortic repair versus medical therapy for early uncomplicated type B dissections

PONE-D-23-19689R3

Dear Dr. Hsu,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

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Kind regards,

Eyüp Serhat Çalık

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

PLoS One. doi: 10.1371/journal.pone.0319561.r009

Acceptance letter

Eyüp Serhat Çalık

PONE-D-23-19689R3

PLOS ONE

Dear Dr. Hsu,

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team.

At this stage, our production department will prepare your paper for publication. This includes ensuring the following:

* All references, tables, and figures are properly cited

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on behalf of

Dr. Eyüp Serhat Çalık

Academic Editor

PLOS ONE

Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

S1. Table. High risk features by initial management in uncomplicated type B aortic syndrome.

(DOCX)

pone.0319561.s001.docx^{(25.5KB, docx)}

S2 Table. Procedural characteristics by initial management in uncomplicated type B aortic syndrome.

(DOCX)

pone.0319561.s002.docx^{(27.2KB, docx)}

S3 Table. Outcomes by initial management in uncomplicated typical type B aortic dissection.

(DOCX)

pone.0319561.s003.docx^{(28.1KB, docx)}

S4 Table. Outcomes by initial management in uncomplicated atypical type B aortic dissection.

(DOCX)

pone.0319561.s004.docx^{(28KB, docx)}

S1 Fig. KM Plot of aggressive group (Excluded cases (Marfan, Maximum aortic diameter > 45mm patient) vs included cases).

(TIF)

pone.0319561.s005.tif^{(635.9KB, tif)}

S1 Data. Pre-TEVAR baseline characteristic of patients.

(XLSX)

pone.0319561.s006.xlsx^{(29.5KB, xlsx)}

S2 Data. Procedural details, early and late outcome.

(XLSX)

pone.0319561.s007.xlsx^{(182KB, xlsx)}

Attachment

Submitted filename: Responses to Reviewers.docx

pone.0319561.s009.docx^{(31.1KB, docx)}

Attachment

Submitted filename: PONE-D-23-19689 _review 04 Jan 2025.docx

pone.0319561.s010.docx^{(16.3KB, docx)}

Attachment

Submitted filename: Response to reviewers 0115.docx

pone.0319561.s012.docx^{(7.7MB, docx)}

Data Availability Statement

All relevant data are within the article and its Supporting Information files.

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PERMALINK

Initial aortic repair versus medical therapy for early uncomplicated type B dissections

Jyh Shinn Teh

Jui-Hsiang Chen

Ying-Ting Kuo

Chun-Yang Huang

Tai-Wei Chen

Chun-Che Shih

Chiao-Po Hsu

Roles

Abstract

Background

Methods

Results

Conclusion

Introduction

Methods

Study population

Outcomes

Statistical analysis

Results

Fig 1. Study flow diagram.

Table 1. Baseline characteristics by initial management in uncomplicated type B aortic syndrome.

Table 2. Outcomes by initial management in uncomplicated Type B aortic syndrome.

Fig 2. Kaplan Meier five-year survival of aggressive and conventional groups in uncomplicated dissection.

Table 3. Aortic remodeling by initial management in uncomplicated typical type B aortic dissection.

Table 4. Aortic remodeling by initial management in uncomplicated Type B IMH.

Discussion

Conclusion

Limitation of study

Supporting information

Data Availability

Funding Statement

References

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