Device Selection in Patients with Borderline Size Aortic Valve Annulus Undergoing Transcatheter Aortic Valve Implantation

doi:10.21203/rs.3.rs-770281/v1

Transcatheter heart valve (THV) selection for transcatheter aortic valve implantation (TAVI) is crucial to achieve procedural success. Borderline aortic annulus size (BAAS), which allows a choice between two consecutive valve sizes, is a common challenge during device selection. In the present study, we evaluated TAVI outcomes in patients with BAAS according to THV size selection. We performed a retrospective study including patients with severe aortic stenosis (AS) and BAAS, measured by multidetector computed tomography (MDCT), undergoing TAVI with self-expandable (SE) or balloon-expandable (BE) THV from the Israeli multicenter TAVI registry. TAVI outcomes were assessed according to the Valve Academic Research Consortium-2 (VARC-2). Out of 2,352 patients with MDCT measurements, 598 patients with BAAS as defined for at least one THV type were included in the study. In BAAS patients treated with SE-THV, larger THV selection was associated with lower rate of paravalvular leak (PVL), compared to smaller THV (45.3% vs. 64.5%; pv = 0.0038). Regarding BE-THV, larger valve selection was associated with lower post-procedural transvalvular gradients compared to smaller THV (mean gradient: 9.9 ± 3.7mmHg vs. 12.5 ± 7.2mmHg; p = 0.019). Of note, rates of mortality, left bundle branch block, permanent pacemaker implantation, stroke, annular rupture and/or coronary occlusion did not differ between groups. BAAS is common among patients undergoing TAVI. Selection of a larger THV in these patients is associated with lower rates of PVL and better hemodynamic profile in patients implanted with SE and BE-THV, respectively, with no effect on procedural complications.

Scientific Communication

Software Engineering

Transcatheter heart valve (THV)

transcatheter aortic valve implantation (TAVI)

Borderline aortic annulus size (BAAS)

multidetector computed tomography (MDCT)

balloon-expandable (BE)

Aortic valve stenosis (AS) is the most common valvular heart disease among elderly¹. Transcatheter aortic valve implantation (TAVI) has become an established and effective therapeutic procedure for symptomatic patients with severe AS regardless of procedural risk^{2, 3}, and recently is offered to a younger and lower risk population. These changes in TAVI candidates emphasize the need for optimal transcatheter heart valve (THV) implantation to achieve procedural success and prolonged durability. The selection of an appropriately sized THV is a crucial component of the TAVI procedure. Valve undersizing may lead to paravalvular leak (PVL), valve embolization and poor hemodynamics. Oversizing may result in coronary occlusion, atrioventricular block, mitral valve injury, septal or annular rupture and periaortic hematoma⁴.

Multidetector computed tomography (MDCT) is the gold standard method for pre-procedural planning and annular sizing of both balloon-expandable (BE) and self-expanding (SE) THV⁵. THVs are currently available in a limited number of sizes and the manufacturer’s sizing guidelines allow for a gray area with considerable overlap, where patients with borderline aortic annulus size (BAAS) may be candidates for either of the two suitable THV sizes (smaller or larger). Meanwhile, BAAS remains a common challenge during device size selection and the most effective THV selection strategy for these patients remains unclear.

Herein, we aim to evaluate the outcomes of TAVI in patients with BAAS according to THV size selection (smaller vs larger), as well as the benefit of shifting between THV types to avoid gray-zone size selection.

Study design and methodology

We performed a retrospective analysis from the Israeli multicenter TAVI registry, including patients with severe symptomatic AS and BAAS, measured by MDCT, undergoing TAVI with SE-THV (CoreValve, Evolut R and Evolut PRO) or BE-THV (Sapien XT, Sapien 3) during the years 2015–2019, at 1 of 4 tertiary centers in Israel. The study was approved by the institutional review board of the Rabin Medical Center, Tel-Aviv Sourasky Medical Center, Chaim Sheba Medical Center and Hadassah Medical Center. All methods were carried out in accordance with relevant guidelines and regulations. The Israeli Multicenter TAVI registry depends upon the Israeli Heart Society and includes anonymized data from 4 tertiary hospital in Israel. Informed consent was waived by the Helsinki Committee of the Tel-Aviv Sourasky Medical center; the Rabin Medical Center institutional review board - Helsinki Committee; the Helsinki Committee of the Chaim Sheba Medical Center and the Helsinki Committee of the Hadassah Medical Center

Eligibility for TAVI was established after a multidisciplinary approach as indicated by the current recommendations. The preoperative workout included MDCT scan to plan the most appropriate route of intervention and to establish the aortic size and dimensions. Aortic sizing and valve measurements were performed by the local team in each center. All centers adopted a transfemoral-first approach policy; other vascular accesses (trans-apical, trans-subclavian, etc.) were considered in cases in which the transfemoral access was not feasible. According to the local policy, TAVIs were performed under local or general anesthesia. The selection of prosthesis type and size was at the discretion of the treating physicians at each center.

Prespecified clinical and laboratory data were collected for all patients at baseline before the procedure, immediately after the procedure, during the index hospitalization, and during long-term follow-up. Collected data included medical history, electrocardiogram, echocardiography studies, MDCT measurements, laboratory tests, and clinical outcomes. Outcomes were collected according to the Valve Academic Research Consortium (VARC) 2 consensus document⁶.

BAAS was defined based on THV manufacturer sizing instructions; size cut-off ± 1mm for SE-THV (62.8 ± 1mm for valve size of 23 vs. 26mm; 72.3 ± 1mm for 26 vs. 29mm; 81.7 ± 1mm for 29 vs. 34mm) and borderline range for BE-THV (330-350mm² for valve size of 20 vs 23mm; 420-440mm² for 23 vs. 26mm; 530-560mm² for 26 vs. 29mm) ⁷. Patients who underwent valve in valve or valve in ring procedures were excluded from the study.

Study Devices

The Evolut R SE valve is constituted by a nitinol frame mounting 3 porcine pericardial leaflets. The valve is repositionable, partially recapturable, and it is deliverable using a dedicated delivery system 14/16-Fr compatible depending on valve size. The Evolut PRO device represents an evolution of its predecessor and features a porcine pericardial outer wrap that contributes to reduce the risk of residual PVL. Evolut R covers a wide range of sizes and is available in 23, 26, 29, and 34 mm sizes⁸; the PRO valve is available in 23, 26, and 29 mm sizes ⁹.

The Sapien XT/3 BE valve incorporates a cobalt chromium stent that mounts bovine pericardial leaflets. Sapien 3, has both an inner and an outer polyethylene terephthalate fabric seal to minimize the risk of PVL. The delivery system has an active 3-dimensional coaxial positioning catheter and a 16-Fr expandable sheath¹⁰.

Statistical methods

Continuous variables were expressed as mean ± standard deviation and compared using Mann-Whitney test. Categorical variables were compared using Chi-square or Fisher's exact tests as needed. All analyses were conducted using Python version 3.5, p value < 0.05 was considered statistically significant.

Out of 2,352 patients following implantation of SE-THV (CoreValve, Evolut R and Evolut PRO) or BE-THV (Sapien XT, Sapien 3) with pre-procedural MDCT measurements, 124 were excluded due to valve in valve, valve in ring or mitral valve interventions. Additional thirty-eight patients with BAAS and an annulus area of 330-350mm² who were implanted with BE-THV were excluded from the analysis since the smaller valve size of 20mm was not implanted. Eventually, 598 patients with BAAS as defined for at least one THV type, 309 for SE-THV, 248 for BE-THV and forty-one patients for both devices were included in the analysis. Of them, 367 (61.4%) patients were implanted with borderline valves, while all others were implanted with non-borderline valves due to shift from SE-THV to BE-THV, or vice versa. The SE-THV group included 93 patients implanted with smaller valves, and 150 patients implanted with larger valves. In the BE-THV group, 22 patients were implanted with smaller valves, and 102 patients with larger valves.

In BAAS patients implanted with SE-THV, the baseline clinical characteristics of both groups (smaller and larger valves) did not differ, except for the New York Heart Association (NYHA) functional class (Table 1A). In addition, no significant differences were observed in imaging (echocardiography and MDCT) measurements (Table 2A). In BAAS patients implanted with BE-THV, differences were noted in left ventricular function (Table 2B). Other measured baseline clinical and imaging characteristics did not differ between smaller and larger valves implantation (Table 1B and Table 2B).

Baseline clinical and imaging characteristics of patients with borderline annulus for SE devices implanted with borderline large SE-THV or non-borderline BE-THV did not differ, except for aortic valve mean pressure gradient (Table 2A). Comparison between non-borderline SE-THV implantation to large BE-borderline valves implantation in patients with borderline annulus for BE devices showed more females and higher Society of Thoracic Surgeons (STS) score in patients implanted with non-borderline SE-THV compared to large BE-borderline valves (Table 1B). In addition, in patients implanted with non-borderline SE-THV the left main (LM) and right coronary artery (RCA) heights were shorter compared with patients implanted with larger BE-borderline valves (Table 2B).

In the present cohort, favorable outcomes were observed while using larger valves in BAAS patients. For SE-THV, selection of larger valves compared to smaller valves was accompanied with significantly lower rates of PVL measured by both echocardiography (none: 54.6% vs. 35.5%, mild: 36% vs. 54.8%, mild to moderate: 7.3% vs. 6.4%, moderate: 2% vs. 2.1%, moderate to severe: 0% vs. 1%; pv=0.0282; Table 3) and angiography (none: 85.3% vs. 68.8%, mild: 13.3% vs. 27.9%, moderate: 1.3% vs. 3.2%; pv=0.0088; Table 3) and a trend toward lower gradients across the THV (7.9∓5.4 vs. 10.2∓10.8; pv=0.083; Table 3); for BE-THV, selection of larger valves compared to smaller valves resulted in better hemodynamics with lower gradients across the THV (9.9∓3.7 vs. 12.5∓7.2; pv=0.019; Table 3). In BE-THV no significant differences were demonstrated in PVL rates while comparing larger to smaller valves implantation in BAAS patients (Table 3). Selection of larger valves (either SE or BE) in BAAS patients did not change the rate of post-dilatation as well as adverse clinical outcomes such as new left bundle branch block (LBBB), rate of new pacemaker implantation, stroke or transient ischemic attack (TIA), annular rupture, coronary occlusion or mortality (Table 3).

Shift from large borderline SE-THV to non-borderline BE-THV was associated with higher gradients across the THV (7.98.5∓5.46.3 vs 12.11∓4.53; pv<0.0001; Table 4); However, lower rates of post-dilatation were observed (38% vs. 12.8%; pv=0.0001; Table 4), but without significant differences in PVL rates (Table 4). In a subgroup of patients who didn’t undergo post-dilatation the PVL rates also did not differ (Table 4). Shift from large borderline BE-THV to non-borderline SE-THV resulted in lower gradients (9.9∓3.7 vs 7.8∓3.5, pv<0.001; Table 4), and increased rates of post-dilatation (7.8% vs. 35.4%, pv<0.001; Table 4) with a trend toward increased overall PVL rated per echocardiography (33% vs. 45.8%, pv=0.08; Table 4). In a subgroup of patients who didn’t undergo post-dilation the PVL rates were increased in non-borderline SE-THV compared to large borderline BE-THV (none: 35.8% vs. 72%, mild: 51.2% vs. 25.8%, mild to moderate: 10.2% vs. 3.37%, moderate: 3% vs 0%, pv=0.001; Table 4).

BAAS is common among patients undergoing TAVI, however, the most effective THV selection strategy for these patients remains unclear. The present study of 598 patients with severe symptomatic AS undergoing TAVI based on the ISRAELI-TAVI registry is the largest observational study to date comparing clinical outcomes according to size selection of SE-THV and BE-THV in patients with BAAS. The main findings of our study (Figure 1) are as follows:

Selection of a larger valve in BAAS patients did not increase adverse clinical outcomes such as new LBBB, rate of new pacemaker implantation, stroke or TIA, annular rupture, coronary occlusion or mortality.
Favorable outcomes were observed while using larger versus smaller valves in BAAS patients. For SE-THV, selection of a larger valve was accompanied by significantly lower rates of PVL and a trend toward lower gradients across the THV; for BE-THV, selection of a larger valve resulted in better hemodynamics with lower gradients across the THV.
Shift from borderline SE-THV to non-borderline BE-THV was associated with lower post-dilatation rates, but with higher THV gradients. Shift from borderline BE-THV to non-borderline SE-THV led to lower gradients, but resulted in increased post-dilatation rates; In addition, in a subgroup of patients in whom post-dilatation was not performed, increased PVL rates were observed.

Large size THV implantation was previously shown to be associated with favorable hemodynamics and lower PVL rate, both associated with better outcomes ^4,¹¹. In fact, evidence shows deleterious prognostic effects even with mild residual PVL after TAVI, including increased mortality^12,¹³. In addition, higher post-TAVI transaortic gradients are associated with decreased THV long-term durability¹⁴. The advantages of implanting larger, over smaller, devices were indeed reflected in our cohort of BAAS patients by lower gradients across BE-THV and lower rates of PVL with SE-THV. These findings are particularly important in the current era, in which younger and relatively healthier patients are being treated with TAVI and in whom the durability of the device is extremely important to minimize the need for future reintervention. Importantly, the use of a larger THV in BAAS patients was not associated with increased adverse outcomes commonly encountered with large prostheses, such as conduction disturbances, annular rupture and coronary occlusion¹⁵^, ¹⁶. Given the above results, the present study advocates the selection of a large THV for BAAS patients undergoing TAVI with either SE or BE prostheses.

In our cohort of BAAS patients, 93% of cases were defined as BAAS for one device only (i.e. either BE or SE). In these patients, it is thus conceivable to apply a strategy of selecting the non-borderline device whenever possible. In fact, non-borderline devices were selected over borderline devices in 38.6% of patients in our cohort. We found that selection of non-borderline SE-THV over borderline BE-THV led to lower gradients, but at the cost of increased rates of post-dilatation or PVL. On the other hand, selection of non-borderline BE-THV over borderline SE-THV was associated with lower rates of post-dilatation, but at the cost of increased gradients. This trade-off between PVL and higher gradients was repeatedly described in comparative studies between BE and SE devices both in tricuspid and bicuspid AS patients^17,¹⁸. These changes were mainly attributed to THV mechanical characteristics, such as annular/supra-annular valve position, radial forces, and the presence of outer skirt¹⁴. Therefore, our findings point out that similar considerations taken while selecting THV type for non-BAAS patients (including calcifications, coronary height, sinus of valsalva dimensions), should be applied also in BAAS patients.

We acknowledge several limitations of our study. The main limitation is the observational nature of the study. Therefore, undocumented factors, such as sinus of valsalva diameter or calcium score, may have affected device selection. In addition, potential impact of unknown or unmeasured confounding factors on study outcomes cannot be excluded. The low number of patients implanted with smaller BE-valve may affect the significance of the results and even necessitated the exclusion of patients with annulus measurements of 330-350mm² from the analysis. BE-TVH over or under-sizing by over or under-inflation of the valve balloon in order to fine tune the valve dimensions was not registered and might have affected in-situ valve size. Nevertheless, the practice of over/under-inflation in the four centers was according to a known algorithm proposed by the company.

The results of the present study support, for both devices (BE and SE), the selection of larger valves for TAVI candidates with BAAS. Shifting from borderline devices to non-borderline devices resulted in significant changes in post-dilatation, PVL and gradients across the THV. Therefore, our findings point out that the same consideration taken while selecting THV type for non-BAAS patients, should be applied in BAAS patients, and whenever a borderline device is selected the larger valve device should be recommended.

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Table 1 A

Baseline clinical characteristics of patients with BAAS for SE-THV, implanted with SE or non-borderline BE-THV. Values are mean ± SD or n (%). DM = diabetes mellitus; BMI = body mass index; STS score = the society of thoracic surgeons scores; NYHA = New York Heart Association; SE = self-expandable; BE = balloon-expandable; THV = transcatheter heart valve. ^*Smaller borderline-SE-THV versus larger borderline-SE-THV. ^#Larger borderline-SE-THV versus non-borderline-BE.

	Smaller borderline-SE-THV (n=93)	Larger borderline-SE-THV (n=150)	Non- borderline BE-THV (n=70)	p value^*	p value^#
Female (%)	52 (56)	88 (58)	50 (71)	0.69	0.07
DM (%)	31 (33)	55 (36)	30 (42)	0.68	0.55
BMI kg/m²	27.6∓5.4	27∓4.6	27.9∓4.2	0.21	0.09
STS score	4.2∓2.3	4.3∓3.3	4.48∓2.86	0.29	0.28
PR interval (ms)	179.7∓40	171∓44	179∓38.7	0.13	0.09
QRS interval (ms)	120∓33	112∓35	104∓33	0.08	0.36
NYHA functional class:				0.03	0.38
I	0 (0)	2 (1.4)	1 (1.4)
II	29 (33)	31 (22)	21 (31)
III	51(58)	78 (55)	37 (54.4)
IV	8 (9)	30 (21)	9 (13.2)

Table 1B

Baseline clinical characteristics of patients with BAAS for BE-THV, implanted with BE or non-borderline SE-THV. Values are mean ± SD or n (%). DM = diabetes mellitus; BMI = body mass index; STS score = the society of thoracic surgeons scores; NYHA = New York Heart Association; SE = self-expandable; BE = balloon-expandable; THV = transcatheter heart valve. ^*Smaller borderline-BE-THV versus larger borderline-BE-THV. ^#Larger borderline-BE-THV versus non-borderline-SE.

	Smaller borderline-BE-THV (n=22)	Larger borderline-BE-THV (n=102)	Non- borderline SE-THV (n=96)	p value^*	p value^#
Female (%)	10 (45.4)	24 (23.5)	61 (63.5)	0.06	1.40e-08
DM (%)	10 (45.4)	43 (42.1)	43 (44.8)	1	0.24
BMI kg/m2	28.6∓3.7	27.5∓4.4	28∓4.9	0.12	0.23
STS score	4∓4.5	3.4∓2.25	4.2∓2.4	0.36	0.003
PR interval (ms)	185∓60	181∓34	174∓34.18	0.42	0.12
QRS duration (ms)	135∓30	121∓33	106.9∓28	0.11	0.05
NYHA functional class:				0.18	0.1
I	1 (4.5)	0 (0)	2
II	5 (22.7)	22 (21.5)	29
III	12 (54.5)	61 (59.8)	44
IV	4 (18)	13 (12.7)	17

Table 2A

Baseline echocardiography and MDCT characteristics of patients with BAAS for SE-THV implanted with SE or non-borderline BE-THV. Values are mean ± SD. LM = left main; RCA = right coronary artery; AV = aortic valve; AVA = aortic valve area; SE = self-expandable; BE = balloon-expandable; THV = transcatheter heart valve; LV = left ventricular. ^*Smaller borderline-SE-THV versus larger borderline-SE-THV. ^#Larger borderline-SE-THV versus non-borderline-BE.

	Smaller borderline-SE-THV (n=93)	Larger borderline-SE-THV (n=150)	Non- borderline BE-THV (n=70)	p value^*	p value^#
Distance of LM (mm)	12.4∓3.2	12.6∓2.6	12.6∓2.7	0.26	0.39
Distance of RCA (mm)	14.8∓3	15.19∓2.9	14.9∓2.8	0.44	0.27
AV mean pressure (mmHg)	45∓15	44∓14	48∓12	0.4	0.02
LV Function				0.189	0.52
Normal (>55%)	65 (70.6)	120 (82)	58 (84)
Mild (45-54%)	7 (7.6)	8 (5.4)	6 (8.6)
Mild-Moderate (40-44%)	6 (6.5)	4 (2.7)	2 (2.8)
Moderate (35-39%)	3 (3.2)	7 (4.7)	1 (1.4)
Moderate-Severe (30-34%)	5 (5.4)	3 (2)	2 (2.8)
Severe (< 29%)	6 (6.5)	4 (2.7)	0 (0)

Table 2B

Baseline echocardiography and MDCT characteristics of patients with BAAS for BE-THV implanted with BE or non-borderline SE-THV. Values are mean ± SD. LM = left main; RCA = right coronary artery; AV = aortic valve; AVA = aortic valve area; SE = self-expandable; BE = balloon-expandable; THV = transcatheter heart valve; LV = left ventricular. ^*Smaller borderline-BE-THV versus larger borderline-BE-THV. ^#Larger borderline-BE-THV versus non-borderline-SE.

	Smaller borderline-BE-THV (n=22)	Larger borderline-BE-THV (n=102)	Non- borderline SE-THV (n=96)	p value^*	p value^#
Distance of LM (mm)	13.8∓2.7	13.69∓3	12.45∓2.49	0.36	0.0006
Distance of RCA (mm)	15.66∓3.2	16∓3.6	14.5∓3.12	0.25	0.0003
AV mean pressure (mmHg)	45∓12.86	41∓16	44.2∓17.4	0.17	0.35
LV function				0.0192	0.35
Normal (>55%)	10 (47.6)	68 (70.8)	76 (80.8)
Mild (45-54%)	3 (14.2)	14 (14.5)	12 (12.7)
Mild-Moderate (40-44%)	5 (23.8)	4 (4.1)	3 (3.2)
Moderate (35-39%)	0 (0)	3 (3.1)	2 (2.1)
Moderate-Severe (30-34%)	1 (4.7)	5 (5.2)	1 (1)
Severe (< 29%)	2 (9.5)	2 (2)	0 (0)

Table 3

Comparison of procedural outcomes between BAAS patients implanted with smaller versus larger valves (SE or BE). Values are mean ± SD or n (%). VARC = valve academic research consortium; TIA = transient ischemic attack; LBBB = left bundle branch block; AV = aortic valve; PVL = paravalvular leak; echo = echocardiography; SE = self-expandable; BE = balloon-expandable; THV = transcatheter heart valve.

	SE-borderline THV		p value	BE-borderline THV		p value
	Smaller (n=93)	Larger (n=150)	p value	Smaller (n=22)	Larger (n=102)	p value
Need for post-dilatation	37 (40)	57 (38)	0.786	1 (4.7)	8 (7.8)	1
device success (VARC-2) (%)	91 (97)	146 (97)	1	22 (100)	101(99)	1
Need for a second valve (%)	2 (2)	2 (1.3)	0.638	0 (0)	2 (1.9)	1
Valve malposition (%)	2 (2)	2 (1.3)	0.638	0 (0)	0 (0)
Valve migration (%)	2 (2)	1 (0.6)	0.565	0 (0)	0 (0)
Ischemic stroke/TIA (%)	3 (3.2)	2 (0.1)	0.616	2 (9)	0 (0)	0.12
Endocarditis (%)	2 (2)	0 (0)	1	0 (0)	1 (0.98)	1
Procedural mortality (%)	1 (1)	2 (0.1)	0.599	0 (0)	0 (0)
Coronary obstruction (%)	0 (0)	0 (0)		0 (0)	0 (0)
New LBBB (%)	21 (23)	34 (23)	0.882	4 (18.1)	29 (28)	0.471
New pacemaker (%)	16 (17)	17 (11.3)	0.4	2 (9)	21 (20)	0.521
AV mean pressure (mmHg)	10.2∓10.8	7.9∓5.4	0.083	12.5∓7.2	9.9∓3.7	0.019
PVL per angiogram			0.0088			0.403
none	64 (68.8)	128 (85.3)		21 (95.4)	88 (86)
mild	26 (27.9)	20 (13.3)		1 (4.5)	14 (13.7)
moderate	3 (3.2)	2 (1.3)		0 (0)	0 (0)
PVL per echo			0.028			0.856
none (%)	33 (35.5)	82 (54.6)		13 (59)	68 (66.6)
mild (%)	51 (54.8)	54 (36)		8 (36)	29 (28.4)
mild-mod (%)	6 (6.4)	11 (7.3)		1 (4.5)	4 (3.9)
moderate (%)	2 (2.1)	3 (2)		0 (0)	1 (0.98)
moderate-severe (%)	1 (1)	0 (0)		0 (0)	0 (0)

Table 4

Comparison of procedural outcomes between patients implanted with large borderline-SE versus non-borderline-BE devices; or large borderline-BE versus non-borderline-SE devices. Values are mean ± SD or n (%). VARC = valve academic research consortium; TIA = transient ischemic attack; LBBB = left bundle branch block; AV = aortic valve; PVL = paravalvular leak; SE = self-expandable; BE = balloon-expandable; THV = transcatheter heart valve; echo=echocardiography. ⁺subgroup of patients who did undergo post-dilatation.

	BAAS for SE device		p value	BAAS for BE device		p value
	Large SE-borderline Valve (n=150)	BE- non-borderline valve (n=70)	p value	Large BE-borderline Valve (n=102)	SE- non-borderline valve (n=96)	p value
Need for post dilatation	57(38)	9(12.8)	0.0001	8(7.8)	34(35.4)	2.97e-06
device success (VARC-2) (%)	146(97)	70(100)	0.554	101(99)	93(96.8)	0.11
Need for a second valve (%)	2(1.3)	0(0)	1	2(1.9)	2(2)	1
Valve malposition (%)	2(1.3)	0(0)	1	0(0)	1(1)	1
Valve migration (%)	1(0.6)	0(0)	1	0(0)	0(0)
Ischemic stroke/TIA (%)	2(0.1)	0(0)	1	0(0)	2(2)	0.508
Endocarditis (%)	0(0)	1(1.4)	0.36	1(0.98)	1(1)	1
Procedural mortality (%)	2(0.1)	0(0)	0.528	0(0)	1(1.6)	0.927
Coronary obstruction (%)	0(0)	2(3.3)	0.166	0(0)	1(1.6)	0.927
New LBBB (%)	34(23)	17(28.3)	0.615	29(28)	27(28.1)	0.737
New pacemaker (%)	17(11.3)	9(15)	0.579	21(20)	17(17.7)	0.499
AV mean pressure (mmHg)	7.9∓5.4	12.1∓4.5	1.70e-10	9.9∓3.7	7.8∓3.5	3.90e-05
PVL per echo⁺			0.246			0.191
none (%)	82(54.6)	47(67.1)		68(66.6)	52(54)
mild (%)	54(36)	20(28.5)		29(28.4)	36(37.5)
mild-mod (%)	11(7.3)	3(4.3)		4(3.9)	6(6.25)
moderate (%)	3(2)	0(0)		1(0.98)	2(2)
Moderate-severe (%)	0(0)	0(0)		0(0)	0(0)
Overall PVL per echo⁺	68(45.3)	23(32.8)	0.106	34(33)	44(45.8)	0.0818
	Large SE-borderline Valve (n=93)	BE- non-borderline valve (n=32)		Large BE-borderline Valve (n=94)	SE- non-borderline valve (n=39)
PVL per echo⁺			0.699			0.0015
none (%)	42 (45.1)	16 (50)		68 (72.3)	14 (35.8)
mild (%)	40 (45.9)	14 (43.7)		23 (25.8)	20 (51.2)
mild-moderate (%)	10 (11.4)	2 (6.25)		3 (3.37)	4 (10.2)
moderate (%)	1 (1.1)	0 (0)		0 (0)	1 (3)
moderate-severe (%)	0 (0)	0 (0)		0 (0)	0 (0)
Overall PVL per echo⁺	51	16	0.413	26	25	0.0003

No competing interests reported.

Device Selection in Patients with Borderline Size Aortic Valve Annulus Undergoing Transcatheter Aortic Valve Implantation

Status:

Version 1

Abstract

Figures

Introduction

Methods

Study design and methodology

Study Devices

Statistical methods

Results

Discussion

References

Tables

Additional Declarations

Status:

Version 1