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Department of Cardiac Surgery, University of Michigan, Ann Arbor, MichMichigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative, Ann Arbor, Mich
Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative, Ann Arbor, MichDivision of Cardiac Surgery, Henry Ford Hospital, Detroit, Mich
Department of Cardiac Surgery, University of Michigan, Ann Arbor, MichMichigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative, Ann Arbor, Mich
Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative, Ann Arbor, MichMeijer Heart and Vascular Institute, Cardiothoracic Surgery, Grand Rapids, Mich
Department of Cardiac Surgery, University of Michigan, Ann Arbor, MichMichigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative, Ann Arbor, Mich
Department of Cardiac Surgery, University of Michigan, Ann Arbor, MichMichigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative, Ann Arbor, Mich
Despite the rapid adoption of transcatheter aortic valve replacement since its approval, the frequency and outcomes of aortic valve reintervention after transcatheter aortic valve replacement are poorly understood.
Methods
Valve reinterventions, either surgical transcatheter aortic valve explantation or repeat transcatheter aortic valve replacement, between 2012 and 2019 were queried using the Society of Thoracic Surgeons Database and the Transcatheter Valve Therapy Registry through the Michigan Statewide quality collaborative. The reintervention frequency and clinical outcomes including observed-to-expected mortality ratio using Society of Thoracic Surgeons Predicted Risk of Mortality were reviewed.
Results
Among 9694 transcatheter aortic valve replacement recipients, a total of 87 patients (0.90%) received a reintervention, consisting of 34 transcatheter aortic valve explants and 53 repeat transcatheter aortic valve replacement procedures. The transcatheter aortic valve explant group demonstrated a higher Society of Thoracic Surgeons Predicted Risk of Mortality. Reintervention cases increased from 0 in 2012 and 2013 to 26 in 2019. The proportion of transcatheter aortic valve explants among all reinterventions increased and was 65% in 2019. Self-expandable devices had a higher reintervention rate than balloon-expandable devices secondary to a higher transcatheter aortic valve explant frequency (0.58% [23/3957] vs 0.19% [11/5737]; P = .001), whereas repeat transcatheter aortic valve replacement rates were similar (0.61% [24/3957] vs 0.51% [29/5737]; P = .51). Among patients with transcatheter aortic valve explants, contraindications to repeat transcatheter aortic valve replacement included unfavorable anatomy (75%), need for other cardiac surgery (29%), other structural issues by transcatheter aortic valve device (18%), and endocarditis (12%). For transcatheter aortic valve explant and repeat transcatheter aortic valve replacement, the 30-day mortality was 15% and 2% (P = .032) and the observed-to-expected mortality ratio was 1.8 and 0.3 (P = .018), respectively.
Conclusions
Aortic valve reintervention remains rare but is increasing. The clinical impact of surgical device explantation was substantial, and the proportion of transcatheter aortic valve explants was significantly higher in patients with a self-expandable device.
Among valve reintervention cases after TAVR, the proportion of TAVR explants increased over time. Self-expandable devices had a higher reintervention rate secondary to a higher TAVR explant frequency.
Among post-TAVR reinterventions, the proportion of TAVR explants increased over time and the TAVR explant group demonstrated a higher PROM. Self-expandable devices had a higher reintervention rate than balloon-expandable devices because of more frequent TAVR explants. The clinical impact of TAVR explant appears substantial, and TAVR repeatability assessment should be weighed at the initial workup.
See Commentaries on pages 2021, 2023, and 2024.
Transcatheter aortic valve replacement (TAVR) is an established alternative to surgical aortic valve replacement (SAVR) for patients with severe symptomatic aortic stenosis, with a growing body of evidence demonstrating the short- and intermediate-term durability of current TAVR devices.
5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial.
However, as TAVR use rapidly increases, little is known about the fate of patients with a failed TAVR device. Despite the consistently higher rates of reintervention in the TAVR cohort compared with SAVR at 5 years in the previous randomized controlled trials,
5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial.
the details for valve reinterventions were not reported. Of particular concern is the complete lack of description regarding the clinical scenarios that led to a surgical TAVR valve explantation.
As we consider the best possible approach for patients suitable for both TAVR and SAVR, who will likely outlive the longevity of the TAVR valve, exceedingly careful thought is required to determine which patients will be best suited for TAVR or SAVR as the initial procedure. This study was undertaken to review the Michigan statewide experience of aortic valve reintervention after TAVR to fully characterize the frequency and clinical outcomes of valve reintervention and ultimately help refine patient selection for TAVR as the initial valve procedure.
Materials and Methods
Data Sources
Clinical data for TAVR explant procedures were collected through the Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative, developed in 2001 as a cardiac surgeon-led quality collaborative initiative embedded in the Michigan Society of Thoracic and Cardiovascular Surgeons including all 33 nonfederal hospitals performing cardiac surgery in Michigan. The Collaborative receives standardized harvest files sent by each center to the Society of Thoracic Surgeons (STS) adult cardiac surgery database.
Clinical data for repeat TAVR procedures were collected through Michigan TAVR, a collaboration between the Michigan Society of Thoracic and Cardiovascular Surgeons and the Blue Cross Blue Shield Cardiovascular Consortium. The Michigan TAVR Coordinating Center receives quarterly data for Michigan from the STS/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry. Patients who received their index TAVRs outside Michigan State were excluded from the analysis.
This study was approved by the University of Michigan Institutional Review Board (HUM00185363, approved on July 17, 2020). The approval included a waiver of informed consent. These data cannot be made available because of data use restrictions. Additional details pertaining to analytic methods are available from the corresponding author upon reasonable request.
Patient Population
The flow diagram of the patient population is summarized in Figure E1.
Identification of Repeat Transcatheter Aortic Valve Replacement Cohort
There were 9752 TAVR procedures identified in the Michigan TAVR database between January 1, 2012, and December 31, 2019. Of these, 50 patients (0.5%) with a mechanically expandable device and 8 patients (0.1%) with intraoperative conversion from TAVR to SAVR were excluded. Second TAVR device implantations during the index procedure were not counted as a repeat TAVR. By using prior aortic valve procedure variables and unique TVT client numbers, patients with at least 2 episodes of care were identified, and this was double-checked by reviewing unchangeable variables, including date of birth, sex, and height in each episode of care. This algorithm yielded 55 repeat TAVR procedures (29 balloon-expandable and 26 self-expandable devices) among 53 patients in the registry.
Identification of Transcatheter Aortic Valve Replacement Explant Cohort
Patients undergoing a SAVR with or without concurrent procedures with a documented prior TAVR procedure or documented TAVR explant during the same study period were identified from the Michigan STS database (n = 42). From these, 8 intraoperative conversions from TAVR to SAVR were excluded, yielding the TAVR explant cohort of 34 patients. Therefore, 87 patients who underwent an aortic valve reintervention, consisting of 34 (39%) with TAVR explants and 53 (61%) with repeat TAVRs, were included as the final cohort of interest.
Definitions and Outcomes
Where possible, the observed-to-expected (O/E) 30-day mortality ratio, calculated by dividing the observed 30-day mortality by the expected 30-day mortality as estimated by the STS Predicted Risk of Mortality (PROM), was used as an outcome measure metric. STS-PROM scores for TAVR explant and repeat TAVR cases were acquired from the STS database and TVT registry, respectively. In contrast, STS-PROM at the time of index TAVR procedure was not available in many patients.
The primary outcome was 30-day mortality. Secondary outcomes included time to reintervention, in-hospital complications, discharge location, 30-day readmission (including both same and different hospital readmissions), and O/E ratio.
Patient TVT (based on version 2.1) and STS data (versions 2.73, 2.81, 2.9) were used by the authors to determine clinical indications for valve reintervention and contraindications to repeat TAVR for patients requiring TAVR explant. Both indications for reintervention and contraindications to repeat TAVR could include more than 1 per patient. More detailed clinical or missing data were retroactively provided by each center to supplement missing information upon request by the Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative.
Statistical Analysis
Continuous variables are expressed as mean ± standard deviation for normally distributed variables and medians (interquartile range [IQR]) for non-normally distributed variables. Normality of continuous variables was assessed using the Shapiro–Wilk test. Categorical variables are presented as proportion and absolute number. Differences between groups were detected using the chi-square test or Fisher exact test for categorical variables and Student t test, Mann–Whitney U test, or Wilcoxon rank-sum test for continuous variables.
Survival data were depicted using the Kaplan–Meier method and the log-rank test with corresponding 95% confidence intervals. Time-to-event curves were created regarding the cumulative frequency of TAVR explant and repeat TAVR from the date of index TAVR with valve reintervention treated as a failure event. For those with more than 1 reintervention, the date of the first reintervention was used for these time-to-event analyses. All P values were the result of 2-tailed tests. The statistical analyses were performed using SPSS 27.0 (IBM-SPSS Inc, Armonk, NY) and Stata 14.2 (StataCorp, College Station, Tex).
Results
Valve Reintervention Frequency in Michigan
The statewide annual commercial TAVR procedure volume has increased every year since 2012 (Figure E2). The number of reinterventions increased from 0 in 2012 and 2013 to 26 in 2019. The proportion of TAVR explants among all reintervention procedures increased and was 65% in 2019 (Figures 1 and E3).
Figure 1Trend of aortic valve reintervention case numbers (red bar: TAVR explant; blue bar: repeat TAVR) and the proportion of TAVR explants (red line) by year. TAVR, Transcatheter aortic valve replacement.
The overall frequency of aortic valve reinterventions between 2012 and 2019 was 0.90% (87/9694 index TAVR procedures), consisting of 1.19% (47/3957) self-expandable device and 0.70% (40/5737) balloon-expandable device implants (P = .012) (Figure 2). Patients with a self-expandable device demonstrated a higher frequency of TAVR explant procedures than patients with a balloon-expandable device (0.58% [23/3957] vs 0.19% [11/5737]; P = .001), whereas the repeat TAVR rate was similar (0.61% [24/3957] vs 0.51% [29/5737]; P = .51). Therefore, the proportion of TAVR explants was significantly higher in patients with a self-expandable device than those with a balloon-expandable device (49% vs 28%; P = .041).
Figure 2Aortic valve reintervention frequency and proportion of TAVR explants among TAVR recipients between 2012 and 2019. The overall frequency of aortic valve reintervention (green bar) was 0.90% (87/9694 index TAVR procedures), consisting of 1.19% (47/3957) self-expandable and 0.70% (40/5737) balloon-expandable device implants (P = .012). Patients with a self-expandable device demonstrated a higher frequency of TAVR explant procedures (blue bars) than patients with a balloon-expandable device (0.58% [23/3957] vs 0.19% [11/5737]; P = .001), whereas the repeat TAVR rate (red bars) was similar (0.61% [24/3957] vs 0.51% [29/5737]; P = .51). TAVR, Transcatheter aortic valve replacement.
Among 157 cardiac surgeons at 33 hospitals in Michigan, 18 surgeons (12%) (median 1 [IQR, 1-2]; range, 1-10 per surgeon) at 10 hospitals (30%) (median, 1.5 [IQR, 1-3.5]; range, 1-17 per center) performed the TAVR explant procedures (Figure E4).
Patient Characteristics
The mean age of patients was 74.9 ± 9.7 years, 44% were female, and 90% demonstrated New York Heart Association class III/IV heart failure (Table 1). The STS-PROM score at the time of reintervention was available in 79 patients (91%) and was 6.1% (IQR, 3.4-10.0). Patients in the TAVR explant group versus repeat TAVR were more likely to be male (71% vs 47%; P = .032), more frequently received a self-expandable device during the index procedure (68% vs 43%; P = .041), and demonstrated a higher STS-PROM (7.7% vs 5.9%; P = .032) with fewer patients in the low-risk category (14% vs 39%; P < .001).
Table 1Patient characteristics at time of aortic valve reintervention
n = 29 patients with TAVR explant and n = 50 patients with repeat TAVR and available STS-PROM.
6.1% (3.4-10.0)
7.7% (5.2-13.4)
5.9% (3.2-9.0)
.032
Low (<4%)
24 (30)
4 (14)
20 (39)
<.001
Intermediate (4%-8%)
25 (32)
10 (36)
15 (29)
.57
High (>8%)
30 (38)
14 (50)
16 (31)
.10
Variables are expressed as numbers (percentages), means ± SDs, or medians (IQR), as appropriate. Bold indicates statistically significant (P < .05). TAVR, Transcatheter aortic valve replacement; CABG, coronary artery bypass grafting; SAVR, surgical aortic valve replacement; NYHA, New York Heart Association; STS-PROM, Society of Thoracic Surgeons Predicted Risk of Mortality.
∗ n = 29 patients with TAVR explant and n = 50 patients with repeat TAVR and available STS-PROM.
The index TAVR device and present aortic valve pathology are summarized in Table 2. Time to valve failure from index TAVR to valve reintervention is depicted in Figure E5. The median time to reintervention was 0.8 (IQR, 0.2-2.2) and 1.6 (IQR, 0.3-3.0) years in the TAVR explant and repeat TAVR groups, respectively (P = .20). Nineteen patients (56%) with TAVR explant underwent a valve reintervention within 1 year after index TAVR and 38% in patients with repeat TAVR.
Table 2Details of the index transcatheter bioprosthesis device and present aortic valve pathology
In regard to clinical indications for reintervention, some patients had more than 1 indication for reoperation. The most common indication was paravalvular leak (PVL)/aortic insufficiency (49%) followed by aortic stenosis (23%). There was a trend toward more frequent mixed aortic stenosis/aortic insufficiency pathology in the repeat TAVR group (26% vs 9%; P = .054). Additionally, 18% in the TAVR explant group had structural issues directly caused by the TAVR device, including mitral impingement (n = 4; 12%), partial left coronary obstruction (n = 1; 3%), and ventricular septal defect (n = 1; 3%). These pathologies were not present immediately after TAVR during the index hospitalization. Other unique indications in the TAVR explant group included endocarditis (12%) and primary aortic root pathology (9%), consisting of growing aortic root aneurysms (n = 2) and pseudoaneurysm due to post-TAVR suture line dehiscence of a previous aortic graft (n = 1).
Valve Reintervention Frequency After Excluding Nontranscatheter Aortic Valve Replacement–Related Clinical Indications
Valve reintervention frequency was recalculated after excluding clinical indications not directly caused by a TAVR device failure including endocarditis and aortic root pathologies. The overall frequency of valve reintervention was 0.83% (80/9687 index TAVR procedures), consisting of 1.09% (43/3953) self-expandable and 0.65% (37/5734) balloon-expandable device implants (P = .022) (Figure E6). Self-expandable devices remained significant with respect to TAVR explant frequency (0.48% vs 0.14%; P = .002), with a 2 times higher proportion of TAVR explant procedures than balloon-expandable device implants (44% vs 22%; P = .033).
Contraindications to Repeat Transcatheter Aortic Valve Replacement
Many patients had more than 1 contraindication. Therefore, the sum of all percentages is greater than 100%. Among patients in the TAVR explant group, contraindications to repeat TAVR included unfavorable anatomy (75%), need for other cardiac surgery (29%), other structural issues by the TAVR device (18%), and endocarditis (12%) (Figure 3). Anatomic reasons for repeat TAVR candidacy exclusion include coronary artery anatomy (n = 9; 27%), other anatomy (n = 9; 27%), and inadequate annulus size (n = 7; 21%). Unfavorable coronary anatomy was associated with insufficient valve-to-coronary distance or sequestered sinus of Valsalva. Insufficient annulus size was seen in patients with a small index TAVR device size with potential resultant redo TAVR device constraint or patient–prosthesis mismatch. Other anatomic factors were mainly related to PVL or index TAVR valve retrograde migration, which was associated with large native perimeter and index valve-in-valve TAVR within stentless bioprosthesis. However, not all patients with TAVR valve failure underwent an image analysis for repeat TAVR evaluation, and the unfavorable anatomy rates likely are underestimated.
Figure 3Contraindications to repeat TAVR in patients with TAVR explant. Many patients had more than 1 contraindication. Therefore, the sum of all percentages is greater than 100%. The leading was unfavorable anatomy (75%) followed by need for other cardiac procedures (29%), other structural issues caused by implanted TAVR valve (18%), and endocarditis (12%). VSD, Ventricular septal defect.
The operative data are summarized in Table 3. Forty-seven percent were redo sternotomies. Implanted surgical valve types included stented (85%) or stentless (6%) bioprosthesis and mechanical prosthesis (9%) with a median size of 25 mm (IQR, 23-27). Two (6%) were unplanned TAVR explant procedures during nonaortic valve procedures (mitral replacement and coronary artery bypass grafting [CABG]), because intraoperative transesophageal echocardiography showed a greater degree of PVL than preoperative transthoracic echocardiography.
Table 3Transcatheter aortic valve replacement explant procedure operative data
Characteristic
TAVR explant (n = 34)
Redo sternotomy
16 (47)
First time redo
15 (94)
Second time redo
1 (6)
Cardiopulmonary bypass time (min)
215 ± 100
Crossclamp time (min)
167 ± 79
Implanted aortic prosthesis
Stented bioprosthesis
29 (85)
Stentless bioprosthesis
2 (6)
Mechanical prosthesis
3 (9)
Implant device size (mm)
25 (23-27)
Concurrent procedures
23 (68)
Annulus/aortic root enlargement
4 (12)
Mitral repair/replacement
10 (29)
CABG
7 (21)
Tricuspid repair/replacement
6 (18)
Aortic repair
11 (32)
Root repair
7 (64)
Full root repair
5 (71)
Partial root repair
2 (29)
Ascending repair
8 (72)
Unplanned aortic repair
4 (36)
Ascending repair
3 (75)
Full root repair
1 (25)
Partial root repair
2 (50)
VSD repair
1 (3)
Multiple combined procedures
10 (29)
Aorta + mitral + tricuspid
1 (3)
Aorta + mitral + CABG
1 (3)
Aorta + CABG
2 (6)
Mitral + CABG
1 (3)
Mitral + tricuspid
2 (6)
Aorta + mitral
2 (6)
Tricuspid + VSD repair
1 (3)
Intra-aortic balloon pumping
2 (6)
Temporary mechanical circulatory support
1 (3)
Variables are expressed as numbers (percentages), means ± SDs, or medians (IQR), as appropriate. TAVR, Transcatheter aortic valve replacement; CABG, coronary artery bypass grafting; VSD, ventricular septal defect.
Concurrent procedures were frequent (68%), consisting of aortic repair (32%), mitral repair or replacement (29%), CABG (21%), tricuspid repair (18%), and ventricular septal defect repair (3%). These aortic repair cases included aortic root repair (64%) and ascending aortic repair (72%). Of these aortic procedures performed, 36% were unplanned aortic repair due to TAVR device adhesions to the contacting aorta, including 3 ascending aortic replacements, 2 partial aortic root replacements, and 1 full aortic root replacement. Furthermore, 29% underwent multiple combined procedures.
Repeat Transcatheter Aortic Valve Replacement
The procedural data are summarized in Table E1. Most procedures were performed through an iliofemoral access. Implanted devices included 23 (43%) self-expandable and 30 (57%) balloon-expandable devices. Concurrent percutaneous coronary intervention was performed in 2 patients (4%). The postprocedure mean pressure gradient across the TAVR valve was 11.0 (IQR, 7.5-16.0) mm Hg, and 15% demonstrated a mean gradient of 20 mm Hg or more. Postimplant PVL was common. More than 30% had at least mild PVL, and 8% had a moderate or severe PVL. One patient (2%) required a second TAVR device implantation due to immediate significant PVL. Despite the second device implantation, the PVL remained moderate in this patient. The procedure outcomes in patients with PVL etiology were similar to patients without PVL (Table E2).
Postoperative Outcomes and Survival
The postoperative outcomes are summarized in Table 4. The 30-day mortality for TAVR explant versus repeat TAVR was 15% and 2% (P = .032), and the O/E ratio was 1.8 and 0.3 (P = .018), respectively. Patients in the TAVR explant group demonstrated a longer length of postoperative hospital stay (10 days vs 3 days; P < .001) and more frequent 30-day readmission (28% vs 8%; P = .023) than patients in the repeat TAVR group. In contrast, 3 patients (6%) with significant PVL in the repeat TAVR group required aortic valve re-reinterventions including a second repeat TAVR procedure (the third TAVR implantation) during the same admission in 2 patients and TAVR explant 180 days after the repeat TAVR procedure in 1 patient. Follow-up was available up to 1 year in both groups. The unadjusted 9-month survival from the time of valve reintervention was 63% ± 11% and 85% ± 8% in the TAVR explant group versus repeat TAVR group (P = .014), respectively (Figure E7).
Outcomes of redo transcatheter aortic valve replacement for the treatment of postprocedural and late occurrence of paravalvular regurgitation and transcatheter valve failure.
whereas the true frequency of valve reinterventions and procedure type among all TAVR recipients is mostly unknown. In this context, the present investigation used real-world multicenter registry data to demonstrate the Michigan experience by linking TVT and STS data through a statewide quality collaborative, which allowed more granular data acquisition.
The primary findings of interest in this study were as follows: (1) The frequency of valve reintervention between 2012 and 2019 was 0.9% after the index TAVR; (2) patients with a self-expandable device demonstrated a higher frequency of valve reintervention versus patients with a balloon-expandable device; (3) the proportion of TAVR explant as a reintervention is increasing and was particularly high in patients with a self-expandable device with nearly half of the reinterventions being TAVR explant; (4) TAVR explants were associated with an excessively high morbidity and mortality; and (5) clinical outcomes after repeat TAVR appeared promising, but the incidence of high valvular gradients, postimplant PVL, and associated valve re-reinterventions were not negligible.
Despite commercially available balloon-expandable and self-expandable valves being used on a large scale, patient-level data evaluating valve reintervention and its clinical significance are lacking. Propensity-matched analyses of the FRANCE-TAVI registry comparing 3910 matched pairs revealed the use of the self-expandable device was associated with a higher risk of PVL and in-hospital and 2-year mortality compared with the use of the balloon-expandable device.
However, no valve reintervention data were provided in their report. The FRANCE-TAVI registry results were partially in line with the Comparison of Transcatheter Heart Valves in High Risk Patients with Severe Aortic Stenosis: Medtronic CoreValve versus Edwards SAPIEN XT (CHOICE) trial in terms of significantly higher frequency of residual aortic insufficiency/PVL in patients with a self-expandable device. However, there was no difference between balloon-expandable and self-expandable valves in all-cause or cardiovascular death, strokes, or readmission at 5 years.
In the CHOICE trial, there were only 3 patients with a valve reintervention in each device type group (of 121 balloon-expandable [2.5%], 120 self-expandable devices [2.6%]), and the details of reintervention were not reported.
In the present study, the overall TAVR explant proportion was 39% (34 TAVR explants/87 reinterventions), and it was higher in patients who received a self-expandable device with approximately half of the patients requiring TAVR explant procedures.
Outcomes of redo transcatheter aortic valve replacement for the treatment of postprocedural and late occurrence of paravalvular regurgitation and transcatheter valve failure.
reviewed the data from 14 centers including 13,876 patients post-TAVR. Fifty patients (0.4%) underwent a repeat TAVR, mostly due to PVL. More updated registry data from a study by Landes and colleagues
describe 212 repeat TAVRs at 37 centers with a frequency of 0.3% (212/63,876). Although outcomes from these repeat TAVR reports were favorable, a major limitation of these studies was exclusion of patients without suitable anatomy for repeat TAVR. Those with unsuitable anatomy are mandated to undergo a TAVR explant pathway or comfort care and death. Moreover, because the main reason for repeat TAVR was PVL, the numbers of valve failure may be underestimated because of the unaccounted PVL closure cases performed.
examined the image-based feasibility of coronary access and repeat TAVR in 137 low-risk patients with a balloon-expandable device. The TAVR device frame reached above the sinotubular junction in 21.2% cases, of which 62% demonstrated the highest risk configuration with valve-to-sinotubular junction distance less than 2 mm. Tang and colleagues
investigated the feasibility of repeat TAVR based on the intraoperative angiographic coplanar 3-cusp view. The authors concluded that repeat TAVR is unfeasible in 21.4% of cases. TAVR repeatability based on these theoretical studies is likely underestimated because these results were based solely on the immediate postoperative image. Other noncoronary anatomic issues and synchronous cardiac pathologies that can arise postimplant were not considered. Furthermore, these analyses were restricted to patients who received balloon-expandable devices. The challenges of coronary access and future repeat TAVR are likely more remarkable in patients with self-expandable devices according to the present study results. Currently, a high valve implantation during TAVR has been recommended and universally practiced to minimize postprocedural pacemaker implantation.
However, applying such an optimized implantation approach may prevent patients the opportunity to receive a repeat TAVR or retain coronary access caused by a relatively high valve implantation.
The main option in patients with a failing TAVR valve without suitable anatomy for a repeat TAVR is a TAVR explant procedure, which appears to be a more morbid procedure than originally thought, as demonstrated in the present study and recent reports.
Outcomes of redo transcatheter aortic valve replacement for the treatment of postprocedural and late occurrence of paravalvular regurgitation and transcatheter valve failure.
Although the TAVR explant group is distinctively different from the repeat TAVR group regarding multiple clinical and anatomic factors, TAVR explant demonstrated a high mortality rate (high O/E ratio = 1.8) in contrast to repeat TAVR (low O/E ratio = 0.3). Our recently published investigation using the STS national database demonstrated a 30-day mortality rate of 19.4% among 782 patients undergoing a TAVR explant with an O/E ratio of 1.54 in patients with isolated SAVR.
In that recent study, 56% of patients receiving TAVR explants required other concurrent procedures, including aortic repair (26%), mitral valve repair (21%), CABG (16%), and tricuspid procedures (6%), which is in line with the present study. Unlike the randomized clinical trial data,
5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial.
real-world application of TAVR without strict exclusion criteria involves a number of patients with various degrees of synchronous cardiac lesions, such as multivessel coronary artery and mitral lesions. The dismal explant-TAVR outcomes may be reflective of the combination of the procedure complexity and the degree of illness in patients.
There is a potential impact of this study on clinical practice. With the growing TAVR adoption in the lower-risk younger population, a careful assessment of repeat TAVR possibility including the choice of TAVR device type should be performed at the initial TAVR workup. We postulate the increasing frequency of TAVR explant resulted from more self-expandable valve use, evolving TAVR implantation technique (high implantation to reduce pacemaker necessity), and inclusion of lower-risk recipients. Given the present study results with approximately 50% of failed self-expandable devices requiring a TAVR explant, the self-expandable device with supra-annular design, which is disadvantageous for valve-to-coronary distance during repeat TAVR, may not be ideal as the initial TAVR choice for the younger population, particularly for those with unfavorable aortic root anatomy for repeat TAVR.
Study Limitations
This study has several limitations. First, it is descriptive, with a relatively small sample size. However, this is the only registry analysis providing both TAVR explant and repeat TAVR data by using linked STS and TVT data, reflective of the current real-world TAVR practice. Second, despite numerous competing events (death) among statewide TAVR recipients, a competing-risks regression analysis, representing more accurate frequency of reintervention rates, was unable to be used because of the lack of long-term survival data. Therefore, the reported aortic valve reintervention rate from the present study is remarkably underestimated. Furthermore, there might have been unaccounted TAVR failure cases without reinterventions among these uncaptured deaths. Third, the STS-PROM score was calculated for isolated SAVR with or without CABG. Underestimation of STS-PROM and resultant overestimation of O/E ratio in patients with TAVR explant with non-CABG concurrent procedures may exist. Fourth, patients who received a reintervention outside Michigan were not captured, although the number is likely small. Fifth, insights into procedural details and longer-term follow-up data are limited in this linked database study. Fourth, the granularity of valve reintervention indications and contraindications to repeat TAVR procedures in patients with explant-TAVR is limited, although this is an inherent limitation of registry studies.
Conclusions
This study highlighted the Michigan statewide experience of aortic valve reintervention after TAVR, which remains a rare event. However, as the role of TAVR has rapidly expanded into the lower-risk aortic stenosis patient population, a substantial increase in the number of TAVR reinterventions is expected in the next decade. The feasibility of repeat TAVR does not appear as high as previous theoretical image-based study results
indicated, particularly for self-expandable devices. Furthermore, the TAVR explant clinical scenario carries a significant risk of morbidity and mortality. In this context, more judicious clinical judgment and candidate selection are extremely crucial, and the multidisciplinary TAVR team should be mindful of “lifetime management” when planning valve type for the initial aortic valve procedure.
Figure 4 represents the graphical summary of the present investigation. Video 1 summarizing the present study is available.
Figure 4Summary of the present study. Among 9694 TAVR recipients in Michigan, 87 patients (0.90%) received a reintervention, consisting of 53 repeat TAVRs (2% mortality) and 34 TAVR explants (15% mortality). The proportion of TAVR explants among all reinterventions increased and was 65% in 2019. Self-expandable devices had a higher reintervention rate than balloon-expandable devices secondary to a higher TAVR explant frequency. Considering the lower than expected feasibility of repeat TAVR procedure and complexity of TAVR explant clinical scenario, careful assessment of TAVR procedure repeatability and extremely thoughtful patient selection should be weighed at the initial TAVR workup. TAVR, Transcatheter aortic valve replacement.
Support for the Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative is provided by the Blue Cross and Blue Shield of Michigan (BCBSM) and Blue Care Network as part of the BCBSM Value Partnerships program. Although BCBSM works collaboratively with the Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative, the opinions, beliefs, and viewpoints expressed by the authors do not necessarily reflect the opinions, beliefs, and viewpoints of BCBSM or any of its employees. S.F. serves as a consultant for Terumo Aortic. H.J.P. serves as a consultant for Medtronic Inc. G.M.D. is on the Medtronic Advisory Board and was supported by Medtronic, as site Principle Investigator for the Pivotal, Extreme, High, SURTAVI, and Low Risk TAVR trials. All money went to the University of Michigan; no personal remuneration was received. D.S. is a member of the Society for Cardiovascular Angiography and Interventions government relations committee. Institutional Review Board Number HUM00185363 (approved July 17, 2020). All other authors reported no conflicts of interest.
The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest.
The authors thank all members of the Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative and Blue Cross Blue Shield Cardiovascular Consortium Coordinating Centers for assistance with this study.
Figure E3Proportion of aortic valve reinterventions to the volume of TAVR procedures by year. Red line represents total valve reinterventions to annual TAVR volume. Green dashed line represents repeat TAVR proportion to annual TAVR volume. Yellow dashed line represents surgical TAVR valve explantation to annual TAVR volume. TAVR, Transcatheter aortic valve replacement.
Figure E6Aortic valve reintervention frequency after excluding nonvalvular and endocarditis clinical indications. The overall frequency of valve reintervention was 0.83% (80/9687 index TAVR procedures), consisting of 1.09% (43/3953) self-expandable and 0.65% (37/5734) balloon-expandable device implants (P = .022). Self-expandable devices remained significant with respect to TAVR explant frequency (0.48% vs 0.14%; P = .002). TAVR, Transcatheter aortic valve replacement.
Figure E7Unadjusted 9-month survival curve from the time of valve reintervention: repeat TAVR versus explant TAVR. Survival curves for the period between 10 and 12 months were truncated because of an insufficient number of patients at risk. TAVR, Transcatheter aortic valve replacement; CI, confidence interval.
5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial.
Outcomes of redo transcatheter aortic valve replacement for the treatment of postprocedural and late occurrence of paravalvular regurgitation and transcatheter valve failure.
Data on the long-term durability of transcatheter aortic valve replacement (TAVR) prostheses after 5 years are limited. With the expansion of TAVR indications across all surgical risk categories, it is expected that there will be an increase in the number of TAVR reinterventions. The optimal type of procedure (repeat TAVR vs surgical TAVR explant and surgical aortic valve replacement [SAVR]) among failed TAVR prostheses is undetermined.
On the basis of clinical evidence of multiple clinical randomized trials, the number of transcatheter aortic valve replacement (TAVR) procedures performed in North America has surpassed the number of isolated surgical aortic valve replacement (SAVR) procedures according to the Society of Thoracic Surgeons Adult Cardiac Surgery Database.1-5 Because TAVR is used in younger patients, valve reintervention is inevitable because of structural valve deterioration, significant paravalvular leak (PVL), severe prosthesis-patient mismatch, endocarditis, or the need for additional procedures.
In this edition of The Journal, Fukuhara and colleagues1 describe the outcomes of aortic valve reintervention following transcatheter aortic valve replacement (TAVR). By analyzing patients from the Michigan Statewide quality collaborative, they found that 87 of 9694 (0.90%) patients received reintervention following TAVR. The median time to reintervention was relatively short (9.6 months), and those who underwent surgical reintervention faced a high mortality rate of 15%.1 The authors are congratulated for their reporting on this important issue.
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