Abstract
Background
The current clinical practice standard is 10% to 20% oversizing of self-expanding valves in transcatheter aortic valve replacement. We aimed to determine whether >20% oversizing of self-expanding valves (Medtronic Evolut) would lead to better valve performance with similar or better outcomes.
Methods
From October 2011 to December 2016, we approached all transcatheter aortic valve replacement patients with a conscious attempt at large oversizing (>20%). The most common valve used, excluding those used in valve-in-valve patients, was the 29-mm Evolut R (29%). We used a retrospective chart review to compare moderate oversizing (group 1; 10% to 20%) with large oversizing (group 2; >20%).
Results
Of 556 patients, 45% were male; the overall mean Society of Thoracic Surgeons risk score was 5.8 ± 3.8. Eighty-five (15%) patients needed a pacemaker, and 21 (3.8%) developed significant paravalvular leak. Mean oversizing was 20.3% ± 6.0%, with 41.4% of patients included in group 1 and 54.5% in group 2. Incidences of complications in group 2 vs. group 1 were as follows: a) paravalvular leak (2.0 vs. 6.1%; odds ratio = 0.31, p = 0.01), b) pacemaker (15 vs. 14%), c) gastrointestinal bleed (n = 4 vs. 0; 1.3 vs. 0.0%; p = 0.03), d) annular dissection (n = 1 vs. 0; 0.3 vs. 0%; p = 0.29), e) mortality (n = 5 vs. 4; 1.6 vs. 1.7%). Incidence of paravalvular leak was higher in those who died than survivors (13 vs. 1.3%; p ≤ 0.0001).
Conclusions
These data suggest that, in current self-expanding valves, >20% oversizing delivers a significantly lower prevalence of paravalvular leak without an increase in other complications. Since paravalvular leak is associated with increased mortality, >20% oversizing may represent a superior prosthesis choice.
Keywords: Complications, Outcomes, Pacemaker implantation, Paravalvular leak, Transcatheter aortic valve replacement
Highlights
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10%-20% oversizing in transcatheter self-expanding aortic valves is current standard.
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In 556 patients, oversizing >20% led to lower rate of paravalvular leak.
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Pacemaker implant and annular rupture rates were similar.
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Large oversizing may be a better treatment strategy.
Introduction
Optimal sizing of the valve in patients undergoing transcatheter aortic valve replacement (TAVR) continues to be a challenge, as oversizing leads to an increased incidence of permanent pacemaker (PPM) implantation and undersizing results in paravalvular leak (PVL), both major determinants of postprocedure prognosis.1 For self-expanding, nitinol-based valves (Medtronic CoreValve, Evolut R, and Evolut PRO, Minneapolis, Minn.), the current industry guidelines call for the use of a prosthetic valve that is 10% to 20% larger than the patient’s valve, with a recommended range of 13% to 31% (personal communication; Medtronic). Multiple prior studies suggested that this oversizing in balloon-expandable valves (Edwards, Irvine, Calif.) led to annular rupture, which was not seen in self-expanding valves, as mentioned in a review article on this topic.2 The PPM implantation rate was quite high, approximately 30%, for both types of valves. The incidence of PVL was similar irrespective of valve type or size. The limitations of these studies included the use of an older version of self-expanding valve (CoreValve) and smaller sample sizes (n = 412 with 283 CoreValve and 129 Edwards SAPIEN valves), thus limiting their generalizability to more modern (Evolut and Evolut PRO) valves.3
We hypothesized that even greater oversizing (>20%) would be associated with a lesser incidence of PVL without an increase in the rate of PPM implantation or other complications and intentionally followed this hypothesis as a policy at our institution over the last several years. This study was carried out to gauge the impact of our large oversizing policy on outcomes.
Methods
Study Setting
From October 2011 to December 2016, all TAVR patients at our large, urban tertiary-care center were approached with a conscious attempt at large oversizing (>20%) with either the Evolut R or Evolut PRO valve. Demographics, echocardiographic data, computed tomographic (CT) data, procedural characteristics, and clinical outcomes were collected from electronic medical records. Critical aortic valve stenosis was defined as an aortic valve area of <0.6 cm2. Aortic valve annular calcification was qualitatively categorized as present if read as moderate or severe by the interpreting radiologist. Discharge status was determined at the moment each patient left the hospital grounds. Death rate was calculated based on patient discharge status. Post-TAVR aortic insufficiency4 was classified as none, trace/trivial, mild, moderate, or severe by transthoracic echocardiogram read on the first postoperative day by a TAVR-dedicated level III echocardiologist. Only a moderate or severe classification was deemed significant.
Each patient received a pre- and post-TAVR echocardiogram so valve function and performance could be examined. Pre-TAVR 3-dimensional multidetector (≥64 slice) CT imaging was performed on all patients in order to examine valve and artery morphology. Oversizing was calculated in reference to the patient’s native aortic annulus perimeter. Relative oversizing by perimeter (%) is equal to the device diameter minus the patient’s CT-scan-measured aortic annulus perimeter, divided by the patient’s CT-scan-measured aortic annulus perimeter, and then multiplied by 100 (personal communication; Medtronic).
Authorization from the Aurora Health Care Institutional Review Board was obtained (IRB #18-22ET) to perform a retrospective review of data, and the requirement for informed consent was waived.
Oversizing Degrees
Patients were divided into 3 groups based on the degree of oversizing of their prosthetic heart valve compared to their annulus size: 0% to 10%, 10% to 20% (moderate), >20% (large).
Definitions of Different Complications
Gastrointestinal (GI) bleed was defined as a patient experiencing GI bleeding associated with any of the following documented in the electronic medical record: hemoglobin drop of ≥3 g/dL, transfusion of whole blood or packed red blood cells, or procedural intervention/surgery at the bleeding site to reverse/stop or correct the bleeding (such as endoscopy with cautery of a GI bleed).
Annular dissection was defined as the indication that there was disruption or tearing of the valve annulus extending to the aorta caused by mechanical injury from oversizing a balloon or the valve device itself.
An unplanned other cardiac surgery or intervention was defined as the patient having subsequently undergone cardiac surgery or a catheterization laboratory intervention that was unplanned. This does not include an intervention or procedure already identified as an adverse event in the STS/ACC TVT Registry (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry).
An event labeled “other bleed” was defined as the patient experiencing bleeding from a site not otherwise specified, such as pulmonary bleeding. To qualify, the bleeding had to be associated with any of the following documented in the medical record: hemoglobin drop of ≥3 g/dL, transfusion of whole blood or packed red blood cells, or procedural intervention/surgery at the bleeding site to reverse/stop or correct the bleeding.
An unplanned vascular surgery or intervention was defined as the patient having required unplanned vascular surgery or intervention to correct a bleeding complication or vascular access site-related complication.
Major vascular complications were defined as any of the following: (a) any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudoaneurysm; (b) access site or access-related vascular injury (dissection, stenosis, perforation, rupture, arteriovenous fistula, pseudoaneurysm, hematoma, irreversible nerve injury, compartment syndrome, percutaneous closure device failure) leading to death, life-threatening or major bleeding,4 visceral ischemia, or neurological impairment; (c) distal embolization (noncerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage; (d) the use of unplanned endovascular or surgical intervention associated with death, major bleeding, visceral ischemia, or neurological impairment; (e) any new ipsilateral lower extremity ischemia documented by patient symptoms, physical examination, and/or decreased or absent blood flow on lower extremity angiogram; (f) surgery for access site-related nerve injury; and (g) permanent access site-related nerve injury.
Minor vascular complications were defined as any of the following: (a) access site or access-related vascular injury (dissection, stenosis, perforation, rupture, arteriovenous fistula, pseudoaneurysms, hematomas, percutaneous closure device failure) not leading to death, life-threatening or major bleeding,4 visceral ischemia, or neurological impairment; (b) distal embolization treated with embolectomy and/or thrombectomy and not resulting in amputation or irreversible end-organ damage; (c) any unplanned endovascular stenting or unplanned surgical intervention not meeting the criteria for a major vascular complication; or (d) vascular repair or the need for vascular repair (via surgery, ultrasound-guided compression, transcatheter embolization, or stent-graft).
All definitions used were those recorded in the STS/ACC TVT Registry Adverse Event Definitions v2.1 and VARC-2 criteria.4
Statistical Analysis
Patient data were collected from the electronic medical record and organized into one dataset. Continuous variable data were represented as mean ± SD. Variables were compared using one-way analysis of variance or Student’s t-test. Nominal data were represented as n (%). Variables were compared using the chi-square test.
Demographics, echocardiographic characteristics, CT characteristics, and clinical outcomes were compared and analyzed across all groups with a focus on the moderate oversizing group and large oversizing group. If any continuous variable had a skewed distribution, a Wilcoxon/Kruskal-Wallis test was performed, or the variable was converted to nominal and a one-way chi-square approximation test was performed.
Bivariate and stratum-specific analyses were performed in order to determine potential confounding variables. A meaningful change in odds ratio (OR) was defined as a >20% change in unadjusted OR, as this is considered a norm in clinical epidemiology circles.5 An alpha value of 0.05 was used to determine the statistical significance of data. All statistical analyses were performed using JMP software (SAS Institute, Cary, North Carolina).
Results
A total of 556 TAVR patients were included in this study (age 82.6 ± 7.4 years, 45% men) after the exclusion of valve-in-valve patients. The mean oversizing was 20.3% ± 6.0% with 4.1% of the patients in the 0% to 10% oversizing group, 41.4% in the 10% to 20% oversizing group, and 54.5% in the >20% oversizing group. The oversizing policy led to the Evolut R 29 mm being the valve most commonly deployed (n = 159; 29%), followed by the Evolut R 34 mm (n = 118; 21.2%), Evolut R 26 mm (n = 107; 19.2%), and Evolut PRO 29 mm (n = 100; 18%). Other sizes were utilized in <10% of patients.
Demographic and clinical characteristics of the patient population are presented in Table 1. The patients who received large oversizing had a statistically significant lower prevalence of diabetes (34.6 vs. 43.9%; p = 0.03), prior PPM (10.2 vs. 17.4%; p = 0.02), and peripheral artery disease (19.8 vs. 29.1%; p = 0.01), as well as a lower STS risk score (5.6 vs. 6.1; p = 0.01).
Table 1.
Demographic and clinical characteristics of population
| Characteristic | Overall | 0%-10% | Moderate oversizing (10%-20%) | Large oversizing (>20%) | p value of 10%-20% vs. >20% oversizing |
|---|---|---|---|---|---|
| Age (y) | 82.6 ± 7.4 | 79.7 ± 7.7 | 83.2 ± 7.0 | 82.4 ± 7.6 | 0.13 |
| Male sex | 250 (45.0) | 21 (91.3) | 89 (38.7) | 140 (46.2) | 0.08 |
| Height (cm) | 164.7 ± 10.9 | 172.6 ± 7.9 | 163.5 ± 11.0 | 165.0 ± 10.9 | 0.10 |
| Weight (kg) | 81.6 ± 31.3 | 89.3 ± 20.0 | 79.9 ± 23.3 | 82.3 ± 36.8 | 0.51 |
| Diabetes mellitus | 216 (38.8) | 10 (43.5) | 101 (43.9) | 105 (34.6) | 0.03∗ |
| Hypertension | 522 (93.9) | 23 (100) | 216 (93.9) | 283 (93.4) | 0.81 |
| Caucasian | 543 (97.7) | 23 (100) | 225 (97.8) | 295 (97.4) | 0.72 |
| Pacemaker | 76 (13.7) | 5 (21.7) | 40 (17.4) | 31 (10.2) | 0.02∗ |
| RBBB | 73 (13.5) | 4 (18) | 29 (13.2) | 40 (13.2) | 0.80 |
| Incomplete RBBB | 16 (3) | 1 (4.6) | 9 (4.1) | 6 (2) | 0.30 |
| LBBB | 31 (5.7) | 0 | 11 (5) | 20 (6.7) | 0.18 |
| Percutaneous coronary intervention | 145 (26.1) | 6 (26.1) | 58 (25.2) | 81 (26.8) | 0.68 |
| Stroke | 55 (9.9) | 4 (17.4) | 23 (10.0) | 28 (9.2) | 0.77 |
| Peripheral artery disease | 133 (23.9) | 6 (26.1) | 67 (29.1) | 60 (19.8) | 0.01∗ |
| Smoker | 30 (5.4) | 1 (4.3) | 14 (6.1) | 15 (4.9) | 0.57 |
| Current dialysis | 22 (4.0) | 3 (13.0) | 6 (2.6) | 13 (4.3) | 0.29 |
| Myocardial infarction | 103 (18.6) | 5 (21.7) | 46 (20.0) | 52 (17.3) | 0.42 |
| Porcelain aorta | 4 (0.7) | 1 (4.3) | 1 (0.4) | 2 (0.7) | 0.73 |
| Atrial fibrillation/flutter | 208 (37.4) | 12 (52.17) | 86 (37.4) | 110 (36.3) | 0.80 |
| Forced expiratory volume | 72.0 ± 21.9 | 65.8 ± 1.1 | 73.5 ± 19.9 | 71.5 ± 23.9 | 0.31 |
| STS risk score | 5.8 ± 3.8 | 5.0 ± 2.6 | 6.1 ± 3.3 | 5.6 ± 4.2 | 0.01∗ |
Notes. Data are presented as mean ± SD or n (%).
Abbreviations: LBBB, left bundle branch block; RBBB, right bundle branch block; STS, Society of Thoracic Surgeons.
10%-20% vs. >20%, p < 0.05.
Of all the echocardiographic characteristics presented in Table 2, all were statistically similar between groups except aortic valve area, which was significantly larger in the large oversizing group (0.76 vs. 0.72 cm2; p = 0.01).
Table 2.
Echocardiographic characteristics of population
| Characteristic | Overall | 0%-10% | Moderate oversizing (10%-20%) | Large oversizing (>20%) | p value of 10%-20% vs. >20% oversizing |
|---|---|---|---|---|---|
| Left ventricular ejection fraction (%) | 57.4 ± 13.1 | 53.4 ± 10.4 | 57.2 ± 13.7 | 57.9 ± 12.7 | 0.72 |
| Right ventricular systolic pressure (mmHg) | 42.7 ± 15.1 | 43.5 ± 11.5 | 43.9 ± 15.6 | 41.6 ± 14.9 | 0.15 |
| Left atrial volume index (mL/m2) | 47.2 ± 19.2 | 50.0 ± 15.3 | 47.5 ± 18.3 | 46.8 ± 20.3 | 0.63 |
| Left ventricular internal diastolic dimension (cm) | 4.6 ± 0.7 | 5.0 ± 0.6 | 4.6 ± 0.05 | 4.6 ± 0.04 | 0.46 |
| Septal wall (cm) | 1.3 ± 0.2 | 1.3 ± 0.3 | 1.2 ± 0.3 | 1.3 ± 0.2 | 0.86 |
| Posterior wall (cm) | 1.2 ± 0.2 | 1.3 ± 0.3 | 1.2 ± 0.2 | 1.1 ± 0.2 | 0.75 |
| Aortic valve area (cm2) | 0.7 ± 0.2 | 0.77 ± 0.17 | 0.72 ± 0.18 | 0.76 ± 0.19 | 0.01∗ |
| Critical aortic valve stenosis† | 94 (17.3) | 2 (8.7) | 43 (19.3) | 49 (16.5) | 0.41 |
| Aortic valve peak gradient (mmHg) | 68.4 ± 22.1 | 60.9 ± 18.7 | 69.9 ± 24.2 | 67.7 ± 20.4 | 0.26 |
Notes. Data are presented as mean ± SD or n (%).
10%-20% vs. >20%, p < 0.05.
Critical aortic valve stenosis = aortic valve area <0.6 cm2.
CT characteristics of the patient population, shown in Table 3, were similar between the moderate and large oversizing groups, except for a slightly smaller aortic valve annulus size (23.6 vs. 24.0 mm; p = 0.04) and a significantly higher prevalence of significant aortic valve annular calcification (46.4 vs. 29.6%; p = 0.0003), a subjective and qualitative measurement by the radiologist, in the large oversizing group. Calcium scores were higher in the large oversizing group (2503 vs. 2354); however, scoring was only performed for 216 out of 556 patients owing to the lack of availability of noncontrast CT studies.
Table 3.
Computed tomography characteristics of population
| Characteristic | Overall | 0%-10% | Moderate oversizing (10%-20%) | Large oversizing (>20%) | p value of 10%-20% oversizing vs. >20% oversizing |
|---|---|---|---|---|---|
| Perimeter (mm) | 76.3 ± 7.3 | 87.9 ± 3.2 | 76.1 ± 6.8 | 75.4 ± 7.1 | 0.25 |
| % of oversizing | 20.3 ± 6.0 | 6.5 ± 2.4 | 16.0 ± 2.2 | 24.6 ± 3.9 | <0.0001∗ |
| Aortic valve annulus size (mm) | 23.9 ± 2.4 | 27.4 ± 1.8 | 24.0 ± 2.3 | 23.6 ± 2.3 | 0.04∗ |
| Sinus of Valsalva left coronary cusp diameter (mm) | 31.9 ± 3.8 | 37.3 ± 2.9 | 31.6 ± 3.7 | 31.9 ± 3.6 | 0.39 |
| Sinus of Valsalva right coronary cusp diameter (mm) | 30.6 ± 3.7 | 36.2 ± 3.4 | 30.3 ± 3.5 | 30.5 ± 3.6 | 0.68 |
| Sinus of Valsalva noncoronary cusp diameter (mm) | 31.8 ± 4.0 | 37.4 ± 3.1 | 31.6 ± 4.2 | 31.6 ± 3.6 | 0.99 |
| Mean sinus of Valsalva diameter (mm) | 31.2 ± 4.7 | 33.8 ± 11.0 | 30.9 ± 4.6 | 31.2 ± 3.9 | 0.46 |
| Left coronary cusp sinus of Valsalva height (mm) | 24.0 ± 3.5 | 29.9 ± 3.6 | 23.8 ± 3.3 | 23.7 ± 3.3 | 0.63 |
| Right coronary cusp sinus of Valsalva height (mm) | 24.1 ± 9.9 | 28.8 ± 4.1 | 23.6 ± 3.0 | 24.1 ± 13.0 | 0.62 |
| Noncoronary cusp sinus of Valsalva height (mm) | 22.4 ± 3.5 | 27.3 ± 4.5 | 22.3 ± 3.4 | 22.1 ± 3.3 | 0.65 |
| Mean sinus of Valsalva height (mm) | 23.3 ± 4.9 | 26.1 ± 9.0 | 23.0 ± 3.5 | 23.2 ± 5.3 | 0.67 |
| Right common iliac mean (mm) | 8.4 ± 2.1 | 9.9 ± 2.4 | 8.3 ± 2.2 | 8.4 ± 1.9 | 0.62 |
| Right external iliac mean (mm) | 7.2 ± 1.6 | 8.0 ± 1.4 | 7.0 ± 1.7 | 7.2 ± 1.5 | 0.23 |
| Right common femoral mean (mm) | 6.9 ± 1.5 | 7.8 ± 1.6 | 6.8 ± 1.6 | 7.0 ± 1.5 | 0.27 |
| Left common iliac mean (mm) | 8.4 ± 2.0 | 9.4 ± 1.6 | 8.4 ± 2.1 | 8.3 ± 1.9 | 0.36 |
| Left external iliac mean (mm) | 7.2 ± 1.5 | 8.2 ± 1.2 | 7.1 ± 1.6 | 7.3 ± 1.5 | 0.15 |
| Left common femoral mean (mm) | 6.9 ± 1.5 | 7.9 ± 1.2 | 6.8 ± 1.5 | 6.9 ± 1.5 | 0.32 |
| Aortic valve annular calcification† | 179 (37.5) | 0 (0) | 56 (29.6) | 123 (46.4) | 0.0003∗ |
| Aortic valve calcium score (n = 216) | 2451.4 ± 1450.9 | N/A | 2354.3 ± 1530.3 | 2503.1 ± 1409.7 | 0.47 |
Notes. Data are presented as mean ± SD or n (%).
10%-20% vs. >20%, p < 0.05.
Classified as present if qualitatively categorized as moderate or severe by the interpreting radiologist.
Of the procedural characteristics shown in Table 4, contrast volume was significantly less in the large oversizing group (50.7 vs. 55.0 mL; p = 0.01). All other variables were similar.
Table 4.
Procedural characteristics
| Characteristic | Overall | 0%-10% | Moderate oversizing (10%-20%) | Large oversizing (>20%) | p value of 10%-20% vs. >20% oversizing |
|---|---|---|---|---|---|
| Evolut PRO | 141 (25.4) | 0 (0) | 60 (26.1) | 81 (26.7) | 0.87 |
| Anesthesia type (MAC) | 497 (89.4) | 22 (95.6) | 198 (86.1) | 277 (91.4) | 0.05 |
| Contrast volume (mL) | 52.6 ± 28.7 | 55.0 ± 14.6 | 55.0 ± 28.8 | 50.7 ± 29.3 | 0.01∗ |
| Fluoroscopy time (min) | 10.4 ± 4.5 | 12.4 ± 4.5 | 10.4 ± 4.6 | 10.2 ± 4.4 | 0.67 |
Notes. Data are presented as mean ± SD or n (%).
Abbreviation: MAC, monitored anesthesia care.
10%-20% vs. >20%, p < 0.05.
Large oversizing had slightly better post-TAVR valve performance (Table 5), consisting of a lower mean gradient (7.5 vs. 7.8 mmHg), larger aortic valve area (2.3 vs. 2.2 cm2), and a similar peak velocity (2.0 vs. 2.0 m/s), but all failed to reach statistical significance.
Table 5.
Post-TAVR valve performance
| Variable | Overall | 0%-10% | Moderate oversizing (10%-20%) | Large oversizing (>20%) | p value of 10%-20% vs. >20% oversizing∗ |
|---|---|---|---|---|---|
| Peak velocity (m/s) | 2.0 ± 0.5 | 2.0 ± 0.4 | 2.0 ± 0.6 | 2.0 ± 0.4 | 0.13 |
| Aortic valve mean gradient (mmHg) | 7.7 ± 3.4 | 8.5 ± 3.7 | 7.8 ± 3.5 | 7.5 ± 3.3 | 0.29 |
| Aortic valve area (cm2) | 2.2 ± 0.6 | 2.3 ± 0.8 | 2.2 ± 0.7 | 2.3 ± 0.6 | 0.14 |
Notes. Data are presented as mean ± SD or n (%).
Abbreviation: TAVR, transcatheter aortic valve replacement.
10%-20% vs. >20%, p < 0.05.
Regarding post-TAVR complications, shown in Table 6, there was a significantly lower prevalence of moderate or severe PVL in the large oversizing group (2.0 vs. 6.1%; p = 0.01). The difference in the incidence of post-TAVR PPM implantation between the moderate and large oversizing groups was insignificant (14.8 vs. 14.3%; p = 0.87). Of all the other possible complications, the occurrence of annular dissection was meaningful (n = 1 vs. 0; 0.3 vs. 0%; p = 0.29). Additionally, the large oversizing group had a statistically significant higher prevalence of GI bleed than the moderate oversizing group (n = 4 vs. 0; 1.3 vs. 0.0%; p = 0.03). At the time of discharge, the mortality rate was similar between groups (n = 5 [large] vs. 4 [moderate]; 1.6 vs. 1.7%; p = 0.94). Since post-TAVR PVL was the only complication that had a statistically significant and clinically meaningful difference in occurrence, this was the only outcome that was converted into an odds ratio and subjected to logistic regression.
Table 6.
Post-TAVR complications
| Complication | Overall | 0%-10% | Moderate oversizing (10%-20%) | Large oversizing (>20%) | p value of 10%-20% vs. >20% oversizing∗ |
|---|---|---|---|---|---|
| Pacemaker | 85 (15.3) | 7 (30.4) | 33 (14.3) | 45 (14.8) | 0.87 |
| Paravalvular leak (moderate or severe) | 21 (3.8) | 1 (4.5) | 14 (6.1) | 6 (2.0) | 0.01∗ |
| Ischemic stroke | 9 (1.6) | 0 (0) | 3 (1.3) | 6 (2.0) | 0.54 |
| Unplanned vascular surgery or intervention | 6 (1.1) | 1 (4.3) | 3 (1.3) | 2 (0.6) | 0.45 |
| Unplanned other cardiac surgery or intervention | 5 (0.9) | 0 (0) | 4 (1.7) | 1 (0.3) | 0.09 |
| Transient ischemic attack | 2 (0.4) | 0 (0) | 0 (0) | 2 (0.7) | 0.13 |
| Perforation with or without tamponade | 3 (0.5) | 0 (0) | 1 (0.4) | 2 (0.7) | 0.73 |
| Percutaneous coronary intervention | 1 (0.2) | 0 (0) | 1 (0.4) | 0 (0) | 0.19 |
| Other bleed | 13 (2.3) | 1 (4.3) | 6 (2.6) | 6 (2.0) | 0.63 |
| Any vascular complication | 14 (2.5) | 0 (0) | 3 (1.3) | 11 (3.6) | 0.08 |
| Minor vascular complications | 13 (2.3) | 0 (0) | 3 (1.3) | 10 (3.3) | 0.13 |
| Major vascular complications | 2 (0.4) | 0 (0) | 0 (0) | 2 (0.7) | 0.13 |
| Genitourinary bleed | 1 (0.2) | 0 (0) | 0 (0) | 1 (0.3) | 0.29 |
| Gastrointestinal bleed | 4 (0.7) | 0 (0) | 0 (0) | 4 (1.3) | 0.03∗ |
| Device migration | 1 (0.2) | 0 (0) | 1 (0.4) | 0 (0) | 0.19 |
| Cardiac arrest | 11 (2.0) | 3 (13.0) | 4 (1.7) | 4 (1.3) | 0.69 |
| Annular dissection | 1 (0.2) | 0 (0) | 0 (0) | 1 (0.3) | 0.29 |
| Atrial fibrillation | 15 (2.7) | 0 (0) | 6 (2.6) | 9 (3.0) | 0.80 |
| Coronary occlusion rate | 0 (0) | 0 (0) | 0 (0) | 0 (0) | N/A |
| Electrocardiographic abnormalities | 168 (30.3) | 6 (26.1) | 74 (32.2) | 88 (29.1) | 0.45 |
| Left bundle branch block | 168 (30.3) | 6 (26.1) | 74 (32.2) | 88 (29.1) | 0.45 |
| Death rate | 10 (1.8) | 1 (4.3) | 4 (1.7) | 5 (1.6) | 0.94 |
Notes. Data are presented as n (%).
Notes. One patient had a major and minor vascular complication.
Abbreviation: TAVR, transcatheter aortic valve replacement.
10%-20% vs. >20%, p < 0.05.
Bivariate analysis was performed on post-TAVR PVL comparing large oversizing to moderate oversizing; the results are presented in Table 7. Large oversizing continued to be associated with reduced PVL, irrespective of confounding by 16 demographic and clinical variables with 69% lower odds (OR = 0.31, 95% CI 0.12-0.83; p = 0.02). These variables included the STS risk score. Of all these variables, only atrial fibrillation/flutter was significantly associated with PVL (OR = 2.67, p = 0.04), independent of the effect of large oversizing.
Table 7.
Bivariate analysis of the association between post-TAVR paravalvular leak and demographic variables
| Model | Odds ratio | 95% Confidence interval | p value |
|---|---|---|---|
| Unadjusted model | |||
| Large vs. moderate oversizing | 0.31 | 0.12-0.83 | 0.02 |
| Model adjusted for age | |||
| Large oversizing | 0.32 | 0.12-0.86 | 0.02 |
| Age | 1.09 | 1.00-1.18 | 0.05 |
| Model adjusted for sex | |||
| Large oversizing | 0.32 | 0.12-0.84 | 0.02 |
| Sex | 0.77 | 0.3-2.0 | 0.59 |
| Model adjusted for height | |||
| Large oversizing | 0.31 | 0.11-0.81 | 0.02 |
| Height | 1.02 | 0.97-1.06 | 0.44 |
| Model adjusted for weight | |||
| Large oversizing | 0.32 | 0.12-0.84 | 0.02 |
| Weight | 0.99 | 0.97-1.01 | 0.39 |
| Model adjusted for diabetes | |||
| Large oversizing | 0.29 | 0.11-0.78 | 0.01 |
| Diabetes | 0.46 | 0.16-1.31 | 0.15 |
| Model adjusted for hypertension | |||
| Large oversizing | 0.33 | 0.12-0.88 | 0.03 |
| Hypertension | 0.28 | 0.08-1.05 | 0.06 |
| Model adjusted for pacemaker | |||
| Large oversizing | 0.31 | 0.12-0.83 | 0.02 |
| Pacemaker | 0.97 | 0.27-3.45 | 0.97 |
| Model adjusted for percutaneous coronary intervention | |||
| Large oversizing | 0.31 | 0.12-0.83 | 0.02 |
| Percutaneous coronary intervention | 0.71 | 0.23-2.16 | 0.54 |
| Model adjusted for smoker | |||
| Large oversizing | 0.31 | 0.12-0.81 | 0.02 |
| Smoker | 7.86e-7† | Too few patients to calculate | 0.99 |
| Model adjusted for stroke | |||
| Large oversizing | 0.31 | 0.12-0.82 | 0.02 |
| Stroke | 0.47 | 0.06-3.61 | 0.47 |
| Model adjusted for peripheral artery disease | |||
| Large oversizing | 0.31 | 0.12-0.82 | 0.02 |
| Peripheral artery disease | 0.92 | 0.32-2.62 | 0.88 |
| Model adjusted for current dialysis | |||
| Large oversizing | 0.31 | 0.12-0.82 | 0.02 |
| Current dialysis | 1.68 | 0.21-13.55 | 0.63 |
| Model adjusted for myocardial infarction | |||
| Large oversizing | 0.31 | 0.12-0.83 | 0.02 |
| Myocardial infarction | 1.06 | 0.34-3.26 | 0.92 |
| Model adjusted for porcelain aorta | |||
| Large oversizing | 0.31 | 0.12-0.83 | 0.02 |
| Porcelain aorta | 7.32e-6† | Too few patients to calculate | 0.99 |
| Model adjusted for atrial fibrillation/flutter | |||
| Large oversizing | 0.31 | 0.12-0.83 | 0.02 |
| Atrial fibrillation/flutter | 2.67 | 1.07-6.68 | 0.04∗ |
| Model adjusted for STS risk score | |||
| Large oversizing | 0.31 | 0.12-0.82 | 0.02 |
| STS risk score | 0.98 | 0.86-1.12 | 0.79 |
Notes. Meaningful change in odds ratio was defined as >20% change in unadjusted odds ratio (<0.248 or >0.372).
Abbreviations: STS, Society of Thoracic Surgeons; TAVR, transcatheter aortic valve replacement.
p < 0.05.
Too few patients to calculate.
Stratum-specific analyses were performed for the association between post-TAVR PVL in different strata of clinical variables (Table 8). Large oversizing was associated with reduced odds of PVL only in octogenarians (age >80 years; OR = 0.29, p = 0.02), those of short stature (males <181.6 cm, females <168.16 cm; OR = 0.31, p = 0.03), the nonobese (body mass index <30; OR = 0.25, p = 0.04), nondiabetics (OR = 0.31, p = 0.04), hypertensives (OR = 0.24, p = 0.02), nonsmokers (OR = 0.31, p = 0.02), those without peripheral artery disease (OR = 0.32, p = 0.04), nondialysis patients (OR = 0.34, p = 0.03), patients with no prior myocardial infarction (OR = 0.23, p = 0.01), and those with an STS risk score <6% (OR = 0.26, p = 0.03).
Table 8.
Stratum-specific analysis of the association between post-TAVR PVL as a function of large vs. moderate oversizing, stratified for demographic variables and clinical variables, shows that the relationship stands in most strata
| Model | Odds ratio | 95% Confidence interval | p value |
|---|---|---|---|
| Unadjusted model | |||
| Large vs. moderate oversizing | 0.31 | 0.12-0.83 | 0.02 |
| Model adjusted for age | |||
| Age >80 | 0.29 | 0.10-0.85 | 0.02∗ |
| Age <80 | 0.62 | 0.04-10.15 | 0.74 |
| Model adjusted for sex | |||
| Female | 0.74 | 0.24-2.24 | 0.59 |
| Male (n = 250) | 5.29E-8† | Too few patients to calculate | 0.99 |
| Model adjusted for height | |||
| Tall | 0.32 | 0.03-3.82 | 0.37 |
| Not tall | 0.31 | 0.11-0.89 | 0.03∗ |
| Model adjusted for obesity (BMI >30) | |||
| BMI >30 | 0.41 | 0.10-1.78 | 0.24 |
| BMI <30 | 0.25 | 0.07-0.96 | 0.04∗ |
| Model adjusted for diabetes | |||
| Diabetes | 0.23 | 0.03-2.12 | 0.20 |
| No diabetes | 0.31 | 0.1-9.3 | 0.04∗ |
| Model adjusted for hypertension | |||
| Hypertention | 0.24 | 0.08-0.77 | 0.02∗ |
| No hypertension | 1.37 | 0.11-17.10 | 0.80 |
| Model adjusted for pacemaker | |||
| Pacemaker (n = 76) | Too few patients to calculate | 0.99 | |
| No pacemaker | 0.37 | 0.13-1.01 | 0.05 |
| Model adjusted for percutaneous coronary intervention | |||
| Percutaneous coronary intervention (n = 145) | Too few patients to calculate | ||
| No percutaneous coronary intervention | 0.45 | 0.16-1.27 | 0.13 |
| Model adjusted for smoking | |||
| Smoker (n = 30) | |||
| Nonsmoker | 0.31 | 0.12-0.81 | 0.02∗ |
| Model adjusted for stroke | |||
| Stroke (n = 51) | Too few patients to calculate | 0.99 | |
| No stroke | 0.33 | 0.12-0.89 | 0.03 |
| Model adjusted for peripheral artery disease | |||
| Peripheral artery disease | 0.27 | 0.03-2.46 | 0.24 |
| No peripheral artery disease | 0.32 | 0.11-0.96 | 0.04∗ |
| Model adjusted for current dialysis | |||
| Current dialysis (n = 22) | Too few patients to calculate | 0.99 | |
| No current dialysis | 0.34 | 0.13-0.92 | 0.03∗ |
| Model adjusted for myocardial infarction | |||
| Myocardial infarction | 0.90 | 0.12-6.65 | 0.92 |
| No myocardial infarction | 0.23 | 0.07-0.74 | 0.01∗ |
| Model adjusted for porcelain aorta | |||
| Porcelain aorta (n = 4) | |||
| No porcelain aorta | 0.31 | 0.12-0.83 | 0.02 |
| Model adjusted for atrial fibrillation/flutter | |||
| Atrial fibrillation/flutter | 0.37 | 0.11-1.28 | 0.12 |
| No atrial fibrillation/flutter | 0.24 | 0.05-1.21 | 0.08 |
| Model adjusted for STS risk score | |||
| STS risk score >6% | 0.43 | 0.08-2.27 | 0.32 |
| STS risk score <6% | 0.26 | 0.08-0.87 | 0.03∗ |
Notes. Height criteria for identifying as tall was defined as ≥168.16 cm for females and ≥181.6 cm for males.
Abbreviations: PVL, paravalvular leak; STS, Society of Thoracic Surgeons; TAVR, transcatheter aortic valve replacement.
p < 0.05.
Too few patients to calculate.
Mortality Data
Of the 556 TAVR patients, 10 died while in the hospital (Table 9). One death occurred in the 0% to 10% oversizing group, 4 in the 10% to 20% oversizing group, and 5 in the >20% oversizing group, with no significant difference between the large and moderate oversizing groups. There were different causes of death in patients, including PVL (n = 3), PPM implantation (n = 2), stroke (n = 1), sepsis (n = 1), hemothorax (n = 1), severe left ventricular systolic function reduction (n = 1), and multifactorial death consisting of pericardial effusion, superficial femoral artery occlusion needing a stent, atrial fibrillation, and GI bleed (n = 1). The incidence of significant PVL was much higher in those who died than in survivors (13 vs. 1.3%; p ≤ 0.0001).
Table 9.
Mortality data
| Pt | Age (y) | Sex | % Of oversizing | STS risk score (%) | Cause of death | Rescue SAVR | Other complications | PVL |
|---|---|---|---|---|---|---|---|---|
| 1 | 90 | M | 8 | 5.26 | PVL | No | Cardiac arrest | Yes |
| 2 | 87 | F | 14 | 12.5 | PPM lead perforation and tamponade | No | None | No |
| 3 | 85 | M | 12 | 4.3 | Stroke | No | Aspiration pneumonia, respiratory failure | No |
| 4 | 81 | M | 11 | 5.4 | PVL | No | Cardiac arrest, cardiogenic shock, family refused emergent SAVR | Yes |
| 5 | 84 | F | 19 | 6.63 | Hemothorax from direct aortic approach | No | Intermittent CHB | No |
| 6 | 68 | M | 30 | 2.6 | PPM | No | CHB, ventricular fibrillation during RV lead insertion | No |
| 7 | 84 | F | 24 | 11 | Severe left ventricular systolic function reduction, pulmonary edema, cardiogenic shock | No | Other bleed, ischemia of right brachial artery | No |
| 8 | 85 | F | 23 | 4.2 | Multifactorial: pericardial effusion, stent, atrial fibrillation, GI bleed | No | None | No |
| 9 | 72 | F | 20 | 14.8 | Sepsis | No | Thrombocytopenia, excessive bleeding, INR too high because of disseminated intravascular coagulation, GI bleed, ischemic hepatitis, hypotension due to shock | No |
| 10 | 85 | M | 20 | 8.9 | PVL and annular dissection | Yes | Ventricular septal defect, stroke, left common carotid dissection | Yes |
Abbreviations: CHB, complete heart block; F, female; GI, gastrointestinal; INR, international normalized ratio; M, male; PPM, pacemaker; Pt, patient; PVL, paravalvular leak; RV, right ventricular; SAVR, surgical aortic valve replacement; STS, Society of Thoracic Surgeons.
Discussion
The current data represent the largest study to date evaluating the hypothesis that bigger self-expanding valves are associated with better outcomes in TAVR patients. The essential findings from this study are that large oversizing significantly reduced the occurrence of PVL and had no significant effect on the postprocedure PPM implantation rate or mortality rate.
Clinical Demographic, Echocardiographic, and Computed Tomographic Variables
Regarding clinical variables, lower prevalence of peripheral artery disease in the large oversizing group is likely indicative that the operator chose a larger valve because the patient was able to receive a 16 Fr sheath.
The STS risk score was significantly lower for the large oversizing group than the moderate oversizing group, which likely suggests that the operator chose healthier patients with larger vessels for a more oversized valve. Previously, Fadahunsi et al.6 found that patients with an increased STS risk score had higher odds of PPM. However, our data did not reveal any difference between the oversizing groups, even when our data were analyzed as in his study (data available on reasonable request to the corresponding author).
With regard to CT characteristics, aortic valve annulus size was smaller in the large oversizing group than the moderate oversizing group, but this difference was not clinically meaningful (23.6 vs. 24.0 mm). The prevalence of moderate or severe aortic valve annular calcification was much greater in the large oversizing group than the moderate oversizing group (Table 3, 46 vs. 29). The presence of greater calcification in the large oversizing group theoretically could have resulted in difficulty in delivery and expansion of the valve. However, this theoretical concern was not supported by our data.
All procedural characteristics were similar between the large and moderate oversizing groups except for contrast volume. Contrast volume was significantly less (50.7 vs. 55.0 mL) in the large oversizing group than the moderate oversizing group. Although, in theory, placement of a larger valve would require more imaging and more use of contrast, our data did not support this theoretical concern. This suggests that the risk of contrast-induced nephropathy would not be increased with large oversizing.
Complications of Large Oversizing vs. Moderate Oversizing in TAVR
Among postprocedure complications, there was no difference in PPM incidence between the large and moderate oversizing groups. However, the incidence of PVL was significantly lower (2 vs. 6%; p = 0.01) in the large oversizing group than in the moderate oversizing group.
The current study is in consonance with other studies in that oversizing reduced post-TAVR PVL (Table 10). All of these studies had a much smaller sample size than our study, with the largest sample size being 202—less than half of our sample size. Similarly, our data are in agreement with four other studies on self-expanding valves, evaluating the mean oversizing and its association with the incidence of PPM implantation (Table 11). The mean oversizing was similar for those who needed post-TAVR PPM implantation and those who did not need it. Our study extends these findings from prior studies, all of which solely utilized an outdated Medtronic CoreValve; our study represents current clinical practice by evaluating the Evolut valve, the current standard of care in self-expanding valves.
Table 10.
Previous studies evaluating % oversizing and PVL rate
| Study | Sample size (n) | Valve type | Age group (mean ± SD) | % OS | Post-TAVR PVL (moderate/severe) |
|---|---|---|---|---|---|
| Abdel-Wahab et al.7 | 120 | CoreValve | 79.6 ± 15.8 y | 14.8% | 5.8% |
| Debry et al.8 | 201 | CoreValve | 80.6 ± 7.2 y | Moderate OS: 2.1-2.5 Severe OS: 2.6-4 |
Moderate OS: 2% Severe OS: 0% |
| Dvir et al.9 | 202 | CoreValve | 81.5 ± 6.7 y | Moderate OS: 2.5%-9.5% Large OS: 9.6%-16.2% |
Moderate OS: 9.8% Large OS: 16.7% |
| Schultz et al.10 | 56 | CoreValve | 80 ± 6 y | 1.38 | 25%∗ |
| Ammar et al. | 556 | Evolut | 82.6 ± 7.4 y | Moderate OS: 10%-20% Large OS: >20% |
Moderate OS: 6.1% Large OS: 2.0% |
Notes. Oversizing criteria varied between studies, making it harder to compare. Abdel-Wahab et al. oversized by perimeter (%), Debry et al. by ratio between prosthesis area and annulus area indexed and measured on multislice computed tomography, Dvir et al. by perimeter (%), Schultz et al. by mean ratio of nominal prosthesis cross-sectional surface area at inflow to cross-sectional surface area of the native annulus, and our study by perimeter (%).
Abbreviations: OS, oversizing; PVL, paravalvular leak; TAVR, transcatheter aortic valve replacement.
Mild PVL.
Table 11.
Previous studies evaluating % oversizing and PPM rate showing the impact of oversizing on PPM incidence
| Study | Sample size (n) | Valve type | Mean % oversizing in patients needing a PPM | Mean % oversizing in patients who did not need a PPM | p value |
|---|---|---|---|---|---|
| Fadahunsi et al.6 | 1096 | CoreValve | 31.8% | 27.8% | <0.001 |
| Schroeter et al.11 | 88 | CoreValve | 4.19 mm | 3.56 mm | 0.10 |
| Ammar et al. | 556 | Evolut | 19.56% | 20.48% | 0.20 |
Notes. Oversizing criteria varied among studies, making it harder to compare. Fadahunsi et al. oversized by area (%), Schroeter et al. by the difference between the actual implanted valve size and the annular diameter as measured by transesophageal echocardiography (mm), and our study by perimeter (%). Our study extends the findings of Schroeter’s study but is in contradiction with Fadahunsi’s study.
The oversizing criteria varied among studies, making it harder to compare post-TAVR PVL and PPM implantation (Tables 10 and 12).6 Fadahunsi et al. oversized by area (%),6 Schroeter et al. by the difference between the actual implanted valve size and the annular diameter as measured by transesophageal echocardiography (mm),11 Schultz et al. by mean ratio of nominal prosthesis cross-sectional surface area at inflow to cross-sectional surface area of the native annulus,10 Debry et al. by the ratio between the prosthesis area and the annulus area indexed and measured on multislice CT,8 and our study by perimeter (%). Our study extends the findings of Schroeter’s study, but it is in contradiction with Fadahunsi’s study (Table 11).
Table 12.
Patients with post-TAVR vascular complications (n = 14)
| Vascular complication | Number of incidents | Major or minor |
|---|---|---|
| Rupture of aortic annulus and ascending aorta, left common carotid artery repair | 2 | Major |
| Femoral (n = 2) and iliac (n = 2) artery dissection or femoral artery occlusion (n = 4) and repair with stent | 7 | Minor |
| Hematoma at access site or pseudoaneurysm | 6 | Minor |
Abbreviation: TAVR, transcatheter aortic valve replacement.
The incidence of GI bleed was 1.3 vs. 0% in the large vs. moderate oversizing groups, but this number was driven by only 1 GI bleed.
The incidence of any post-TAVR vascular complication for our large oversizing group was much lesser than that reported in prior studies (3.6% in our study vs. 12.8% in Abdel-Wahab et al.7) despite the fact that our study oversized the valves by a greater amount (mean overall oversizing by perimeter was 20.3% in our study vs. 14.8% in the study by Abdel-Wahab et al.).
The incidence of major vascular complications was not significantly different between our large oversizing patients and moderate oversizing patients (0.66 vs. 0%; p = 0.13) and was much lower than that reported by Dvir et al. (10% in large oversizing vs. 7.1% in moderate oversizing; 0.07).9 The incidence of vascular complications in TAVR has decreased from 34% in the early-generation TAVR era (2008; owing to 24 Fr sheaths), to 9% in 2012 with a 16 Fr sheath, to even lower in our study (2.5%), which likely also reflects greater operator experience as well as most of our patients having undergone surgical cutdown.
The one patient who experienced annular dissection had severe calcification of the aortic valve, with a calcification score of 7174. This patient also had severe subaortic calcification that interfered with optimal delivery of the valve. During valve delivery, the first two valves were placed too deep below the aortic annulus, leading to severe PVL. A third valve was placed that had less PVL, but the patient developed further hemodynamic compromise. The patient underwent emergency thoracotomy and was found to have an annular rupture and a ventricular septal defect, likely secondary to balloon valvuloplasty of the prior valve. This patient expired on the surgeon’s table. Although this patient belonged to the large oversizing group, the mortality was more related to aortic valve annulus calcification and subaortic calcification, which made it difficult to deliver the valve at optimal position. In our opinion, this annular dissection does not provide evidence against our practice of oversizing, which is based on the premise that self-expanding valves can be oversized and still may not cause rupture as they do not need active balloon dilation/valvuloplasty, which is needed by balloon-expandable valves. It, in fact, provides evidence that balloon dilation/valvuloplasty predisposes the patient to annular rupture.
Confounding and Effect Modification in the Relationship Between Large Oversizing and PVL
Bivariate analysis to evaluate the relationship between large oversizing and PVL demonstrated that the beneficial association persisted irrespective of any of the confounding variables (Table 7). Stratum-specific analyses revealed that in many strata, the beneficial association between large oversizing and PVL persisted (Table 8). There was significant biological interaction, with persistence of the beneficial relationship only in the following strata of patients: octogenarians, those who were short of stature, those who were not obese, those who were not diabetic, hypertensives, nonsmokers, those without peripheral artery disease, nondialysis patients, patients with no prior myocardial infarction, and those with an STS risk score <6%.
To illustrate these findings, we displayed the individual findings from two cases comparing two otherwise similar patients, one of whom received moderate oversizing and the other large oversizing. Figure 1 shows that these 2 patients had similar aortic valve calcium scores, perimeter, and mean sinus of Valsalva diameter. Figure 2 shows each patient’s post-TAVR electrocardiogram and echocardiogram results: the patient with moderate oversizing had severe PVL and PPM implantation immediately post-TAVR, whereas the patient with large oversizing had trace PVL and no immediate PPM implantation.
Figure 1.
Illustrative cases of 2 transcatheter aortic valve replacement patients. The patients had similar calcification score, perimeter, and sinus of Valsalva diameter; one received a valve with moderate oversizing, the other a valve with large oversizing.
Figure 2.
Outcomes of the 2 patients from Figure 1. The patient with moderate oversizing (15% oversizing; Evolut R 29 mm) suffered from severe PVL and needed immediate PPM implantation, whereas the patient with large oversizing (30% oversizing; Evolut R 34 mm) did not have either complication.
Abbreviations: PVL, paravalvular leak; TAVR, transcatheter aortic valve replacement.
Clinical Implications
Data generated in this study support the possibility that oversizing >20% may be beneficial for reducing PVL without the cost of increased PPM incidence but at the cost of other procedural complications.
Strengths and Limitations
All the patient data collected for this study were from one institution. It suffers from selection bias as it represents the institutional clinical policy of preferring large oversizing over moderate oversizing. STS risk score was significantly lower in the large oversizing group, likely suggesting that the operator selected healthier patients with larger vessels for the more oversized valves. This selection bias could partially explain the reduced complications seen in the large oversizing group. However, the strength of this study is that the data were collected prospectively, which reduces the recall bias.
Conclusions
This study suggests that in self-expanding valves, a policy of large oversizing (>20%) is superior to standard clinical practice. Large oversizing leads to significantly lesser PVL post-TAVR without the cost of an increased incidence of PPM or major vascular complications. That large oversizing was associated with PVL reduction irrespective of confounding variables suggests that this reduction was a direct result of the larger oversizing. Stratum-specific analyses indicated that the benefit of large oversizing is more evident in specific subgroups, making it likely that the recommendation for >20% oversizing may need to be tailored to the individual patient’s profile.
CRediT Authorship Contributions
Khawaja Afzal Ammar (Study conception and design, Data analysis and interpretation, Drafting the manuscript, Critical revision). Jodi Zilinski (Study conception and design, Data analysis and interpretation, Critical revision). Daniel P. O’Hair (Study conception and design, Data analysis and interpretation, Critical revision). Renuka Jain (Study conception and design, Data analysis and interpretation, Critical revision). Suhail Q. Allaqaband (Study conception and design, Data analysis and interpretation, Critical revision). Tanvir Bajwa (Study conception and design, Data analysis and interpretation, Critical revision). Alexandria Graeber (Data acquisition, Data analysis and interpretation, Drafting the manuscript). Abdur Rahman Ahmad (Data acquisition, Data analysis and interpretation, Drafting the manuscript). All authors reviewed and approved the final manuscript.
Ethics Statement
Authorization from the Aurora Health Care Institutional Review Board was obtained (IRB #18-22ET) to perform a retrospective review of data, and the requirement for informed consent was waived.
Funding
The authors have no funding to report.
Prior Presentation
An earlier version of this research was presented at the American College of Cardiology Scientific Sessions, 2019, in New Orleans, LA.
Disclosure Statement
T. Bajwa, R. Jain, and D. P. O’Hair are consultants for Medtronic. The other authors had no conflicts to declare.
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