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TAVI With or Without Predilation: Trends From a Large, Propensity-Score Weighted German Aortic Valve Registry (GARY) Population
Abstract
Background and Aims. Currently, it is unclear whether transcatheter aortic valve implantation (TAVI) without predilation (direct TAVI; d-TAVI) or with preimplantation balloon valvuloplasty (b-TAVI) provides similar clinical safety and efficacy. Therefore, we analyzed patients undergoing d-TAVI or b-TAVI for severe aortic stenosis (AS) with either self-expanding or balloon-expandable transcatheter heart valves (THVs) from the German Aortic Valve Registry (GARY). Methods. Between 2011 and 2017, a total of 44,783 TAVI patients were collected, with 25,717 (57.4%) receiving a balloon-expandable THV and 19,066 (42.6%) receiving a self-expanding THV. A propensity-score weighted model was used to compare d-TAVI vs b-TAVI regarding differences in outcome. Results. B-TAVI was performed in 71% and d-TAVI was performed in 29% of patients. In the investigated time interval, frequency of b-TAVI declined from 88.4% to 58.2%, accompanied by a constant rate of postdilation. After propensity weighting of patients receiving balloon-expandable THV, d-TAVI vs b-TAVI was associated with more frequent postoperative transvalvular mean pressure gradients (mPG) >15 mm Hg (20.7% vs 18.4%; P<.001), similar rates of paravalvular leakage (PVL) ≥ moderate (18.0% vs 16.9%; P=.08), fewer postdilations (13.4% vs 15.5%; P<.001), and fewer complications (permanent pacemaker implantation, 10.2% vs 11.9% [P=.01]; vascular complications, 1.9% vs 2.6% [P<.01]; pericardial tamponade, 0.5% vs 0.9% [P<.01]; and stroke, 0.9% vs 1.3% [P=.02]). In patients receiving self-expanding THVs, d-TAVI vs b-TAVI was associated with more frequent postimplantation mean PG ≥ 15 mm Hg (12.7% vs 10.4%; P<.01), higher rates of PVL ≥ moderate (24.8% vs 16.5%; P<.001), and similar complication rates including permanent pacemaker implantation. Conclusions. The safety and efficacy of d-TAVI vs b-TAVI depends on the type of THV implanted. For balloon-expandable valves, d-TAVI provides an advantage, while self-expanding valves offer a similar safety profile for d-TAVI compared with b-TAVI. However, increased mPG post intervention with both valve types and more significant PVL in self-expanding THVs emphasize the importance of proper patient selection and evaluation of valve anatomy to identify suitable cases for d-TAVI.
J INVASIVE CARDIOL 2022;34(12):E841-E849. Epub 2022 November 23.
Key words: TAVI, predilation, self-expanding valve, balloon-expanding valve, balloon aortic valvuloplasty
Transcatheter aortic valve implantation (TAVI) has become the standard of care for elderly patients with severe aortic stenosis (AS).1-5 Despite documented significant improvements in outcomes, mostly due to increased operator experience, enhanced valve technology, and patient selection, TAVI is still associated with complications related to procedure-inherent risks.6-8 Therefore, the reduction of periprocedural complications is of paramount importance before the expansion of TAVI for the treatment of younger and lower-risk patients can be taken into consideration.
Predilation with balloon aortic valvuloplasty (BAV) has been an important procedural step for facilitating both device implantation and expansion. However, several studies have provided evidence that BAV may be associated with increased rates of periprocedural stroke, aortic regurgitation, and vascular access-related complications, especially in high-risk patients.9-11 Since the advent of new-generation balloon-expandable transcatheter heart valves (THVs), characterized by a low profile and steerable delivery system, crossing of the valve is facilitated, and direct TAVI (d-TAVI) has been considered an attractive option to avoid complications and simplify the procedure.12,13
Previous studies investigating the safety and feasibility of d-TAVI included small patient numbers and presented inconclusive results.14-17 Although d-TAVI may be currently used frequently in clinical daily routine, there is still uncertainty whether predilation with BAV during TAVI for severe AS is beneficial in terms of clinical safety and efficacy. The aim of this study is to compare the effectiveness of balloon predilation before TAVI (b-TAVI) vs d-TAVI on clinical and periprocedural outcomes in a large cohort of patients from the German Aortic Valve Registry (GARY).
Methods
Registry design and patient population. GARY is the largest prospective, multicenter registry that monitors the safety and efficacy of interventional and surgical aortic valve procedures in Germany. The design of this all-comers registry has been described in detail previously.18 The present analysis includes data of patients treated with TAVI for severe AS between 2011 and 2017. Demographic, clinical, procedural, and in-hospital data were analyzed. The investigators had full access to the data and control of the analysis. Initial approval for GARY was obtained from the Freiburg International Ethical Committee, and patients gave written informed consent prior to the procedure.
Between 2011 and 2017, a total of 135,160 patients entered the registry, with 83,337 patients undergoing aortic valve surgery and 51,823 undergoing TAVI. After excluding patients with non-plausible characteristics, a total of 44,783 patients remained for further analysis. Of these, a total of 31,880 received b-TAVI and 12,903 received d-TAVI.
Study endpoints. The primary study endpoint was procedural success according to the Valve Academic Research Consortium (VARC)-2 criteria.19 According to these criteria, procedural success is defined as the absence of immediate procedural mortality, correct positioning of a single THV and intended performance of the prosthetic valve (mean transvalvular pressure gradient [PG] <20 mm Hg and absence of moderate or severe regurgitation).2
Secondary endpoints included periprocedural myocardial infarction (MI) and stroke, procedural parameters (length of procedure, radiation exposure, amount of contrast agent, incidence of postdilation), and postprocedural complications, including new permanent pacemaker implantation (PPI) and vascular access complications. Postdilation was defined as balloon dilation of the THV prosthesis during the index procedure.
Statistical analysis. Baseline and procedural characteristics of patients are shown as mean ± standard error (SD) for continuous variables and as percentages and frequencies for categorical variables. Comparisons were performed with the Mann–Whitney U test or weighted non-parametric rank test for continuous variables and with the χ2 test or the univariate weighted logistic regression for categorical variables. A weighted propensity score (PS) model was used to adjust the comparison of characteristics between BAV and non-BAV groups. Variables included in the PS model were age, Society of Thoracic Surgeons (STS) score, logistic EuroScore I, gender, serum creatinine, presence of neurological dysfunction, lung disease, previous cardiac surgery, degree of aortic valve calcification, and presence of a pacemaker or defibrillator lead. Patients receiving BAV were weighted with this model in a way that variables included in the PS model are approximately comparable with those of the no-BAV patients. A 2-sided P-value of <.01 was considered statistically significant. Statistical analysis was performed with SAS statistical software, version 9.4 (SAS Institute) and R (R Foundation for Statistical Computing). The R package “twang” was used for calculating PS weights and the corresponding weighted analysis.
Results
Trends in b-TAVI vs d-TAVI and in postdilation. Among the total 44,783 patients, b-TAVI was performed in 31,880 patients (71.2%) with no differences between THV types (18,224 balloon-expandable THVs [70.9%]; 13,656 self-expanding THVs [71.6%]). Conversely, d-TAVI was performed in 12,903 patients (28.8%), with balloon expandable THVs utilized in 7493 (29.1%) and self-expanding THVs utilized in 5410 (28.4%).
From 2011 to 2017, the percentage of b-TAVIs per year declined in the overall cohort (88.4% to 58.2%), as well as in patients receiving balloon-expandable valves (95.1% to 51.8%) and in patients receiving self-expanding valves (80.0% to 63.5%) (Figure 1A).
Postdilation was performed in 9327 patients overall (20.8%); it was less frequent in balloon-expandable vs self-expanding THV groups (3768 [14.7%] vs 5559 [29.2%], respectively).
The frequency of postdilation between 2011 and 2017 is depicted in Figure 1B. In the overall population, the frequency of postdilation remained mostly constant throughout the study interval (from 22.0% to 23.5% over the study period from 2011 to 2017). Patients receiving balloon-expandable prostheses had constantly lower postdilation rates compared with those receiving self-expanding prostheses (15.4% to 14.4% vs 30.2% to 31.1% throughout 2011 to 2017, respectively).
Baseline characteristics of the overall study population. Overall unadjusted baseline characteristics of all patients, according to b-TAVI vs d-TAVI, are shown in Table 1. Both groups differed significantly regarding demographic characteristics, comorbidities, and value of AVA. From the overall study population, 25,717 patients (57.4%) received balloon-expandable prostheses and 19,066 (42.6%) received self-expanding prostheses. Patients provided with b-TAVI presented with lower comorbidity burden and consecutive lower risk stratification values, but smaller preoperative effective orifice areas.
Baseline characteristics after PS adjustment. After data adjustment, the majority of preoperative intergroup differences were balanced. Residual significant differences remained regarding previous PCI (31.6% in the b-TAVI group vs 34.1% in the d-TAVI group; P<.001), severe tricuspid regurgitation (2.6% in the b-TAVI group vs 3.8% in the d-TAVI group; P<.001), left ventricular ejection fraction <30% (6.9% in the b-TAVI group vs 9.4% in the d-TAVI group; P<.001), and previous heart failure episodes, effective orifice area, mean transvalvular pressure gradient, pulmonary hypertension, and diabetes mellitus. Detailed baseline characteristics after data adjustment are shown in Table 2.
Periprocedural data and outcomes after PS adjustment. Detailed peri-and postprocedural outcomes after PS weighting of b-TAVI vs d-TAVI are documented in Table 3. A depiction of clinical safety and efficacy of d-TAVI vs b-TAVI is shown in Figure 2. After PS adjustment, b-TAVI vs d-TAVI was associated with lower rates of mPG ≥15 mm Hg (15.1% vs 17.6%, respectively; odds ratio [OR], 1.20; 95% confidence interval [CI], 1.11-1.30; P<.001), less frequent significant paravalvular leakage (PVL ≥ moderate; 16.7% vs 20.8%, respectively; OR, 1.31; 95% CI, 1.23-1.40; P<.001), and longer procedural duration (82.3 ± 0.3 minutes vs 78.8 ± 0.4 minutes, respectively; P<.001), higher use of contrast agent (138.8 ± 0.52 mL vs 131.4 ± 0.66 mL, respectively; P<.001), and higher radiation exposure (dose area product, 6,344,599 ± 32,356 cGy•cm2 vs 6,044,285 ± 41,145 cGy•cm2, respectively; P<.001).
B-TAVI vs d-TAVI was further associated with more frequent need for rapid pacing (74.2% vs 65.9%, respectively; OR, 0.67; 95% CI, 0.64-0.71; P<.001), more frequent postdilation (21.1% vs 19.5%, respectively; OR, 0.91; 95% CI, 0.86-0.97; P<.01), higher incidence of new PPI (15.2% vs 14.0%, respectively; OR, 0.91; 95% CI, 0.83-0.99; P=.04), more frequent pericardial tamponade (0.8% vs 0.5%, respectively; OR, 0.64; 95% CI, 0.47-0.88; P<.01), and more frequent stroke (1.4% vs 1.0%, respectively; OR, 0.74; 95% CI, 0.59-0.93; P=.01).
Outcomes after PS adjustment in the subgroup receiving a balloon-expandable prosthesis. Adjusted data for patients receiving a balloon-expandable prosthesis are depicted in Figure 2B. In TAVI utilizing balloon-expandable THVs, b-TAVI vs d-TAVI was associated with lower rates of postprocedural increased aortic valve mPG (≥15 mm Hg; 18.4% vs 20.7%, respectively; OR, 1.16; 95% CI, 1.05-1.28; P<.01), longer procedure duration (81.4 ± 0.38 minutes vs 76.1 ± 0.51 minutes, respectively; SD, -0.13; P<.001), increased amount of used contrast agent (132.9 ± 0.66 mL vs 122.9 ± 0.83 mL, respectively; SD, -0.13; P<.001), higher radiation exposure measured by DAP (6,110,411 ± 40,518 cGy•cm2 vs 5,574,756 ± 52,391 cGy•cm2, respectively; SD, -0.165; P<.001), more frequent postdilation (15.5% vs 13.4%, respectively; OR, 0.85; 95% CI, 0.77-0.92; P<.001), increased rates of postinterventional PPI (11.9% vs 10.2%, respectively; OR, 0.84; 95% CI, 0.74-0.96; P=.01), more frequent pericardial tamponade (0.9% vs 0.5%, respectively; OR, 0.53; 95% CI, 0.35-0.80; P<.01), increased vascular complications (2.6% vs 1.9%, respectively; OR, 0.72; 95% CI, 0.58-0.90; P<.01), and more frequent stroke (1.3% vs 0.9%, respectively; OR, 0.69; 95% CI, 0.50-0.93; P=.02). Rates of PVL ≥ moderate (16.9% vs 18.0%, respectively; P=.08) (Figure 3A) and myocardial infarction (0.4% vs 0.2%, respectively; P=.05) were similar in both groups.
Outcomes after PS adjustment in the subgroup receiving a self-expanding prosthesis. Adjusted data for patients receiving a self-expanding prosthesis are given in Figure 2C. B-TAVI vs d-TAVI was associated with less frequent mPG ≥15 mm Hg (10.4% vs 12.7%, respectively; OR, 1.26; 95% CI, 1.09-1.46; P<.01), less frequent ≥ moderate PVL (16.5% vs 24.8%, respectively; OR, 1.66; 95% CI, 1.51-1.83; P<.001) (Figure 3B), and higher use of contrast agent (147.0 ± 0.83 mL vs 143.2 ± 1.07 mL, respectively; SD, -0.05; P<.01). Procedure duration (83.3 ± 0.46 minutes vs 82.6 ± 0.61 minutes; P=.30), radiation exposure measured by DAP (6,631,910 ± 52,173 cGy•cm2 vs 6,628,487 ± 64,674 cGy•cm2, respectively; SD, -0.001; P=.96), rate of balloon postdilation (28.1% vs 28.1%, respectively; P>.99), new-onset conduction disturbances with need of PPI (20.2% vs 19.1%, respectively; P=.25), pericardial tamponade (0.5% vs 0.5%, respectively; P=.81), vascular complications (3.7% vs 3.8%, respectively; P=.87), stroke (1.5% vs 1.1%, respectively; P=.13), and myocardial infarction (0.4% vs 0.5%, respectively; P=.54) were similar in both groups.
Discussion
The main findings of this large PS-matched study investigating the effects of d-TAVI compared with B-TAVI in patients undergoing TAVI are: (1) throughout the study period, a dramatic increase in the rate of d-TAVI was observed. This trend was independent of the rate of performed postdilatations; and (2) the effects of d-TAVI compared with b-TAVI regarding safety and efficacy depend on the type of THV, irrespective of the degree of AV calcification. In patients receiving a balloon-expandable THV, d-TAVI is associated with shorter procedure time and radiation exposure, fewer postdilations; and reduced periprocedural complications. The rate of PVL ≥ moderate was similar, but postprocedural mPG ≥15 mm Hg was more frequent. In patients receiving a self-expanding THV, d-TAVI was associated with similar procedure time and similar rates of postdilations and complications, but higher rates of postprocedural mPG ≥15 mm Hg and PVL ≥ moderate compared with b-TAVI.
Until recently, b-TAVI was the standard of care, but over the past years, numbers have dramatically decreased. This may be in part due to increased operator experience, improved THV technology, and/or patient screening. However, in patients with severe AV calcifications, predilation with BAV is still considered mandatory in most centers to achieve optimal procedural results in terms of postoperative hemodynamics. In this analysis of the GARY database comparing b-TAVI with d-TAVI, we saw a continuous increase in rates of d-TAVI in both THV types, without an increase in postdilation rates in the entire patient cohort. The finding of stable postdilation rates despite a decrease of BAV in TAVI is different from previous studies. The EASE-IT registry reported a reduction of postdilation requirements by BAV in patients with a greater degree of leaflet calcification.20 To elucidate this aspect, in our study, b-TAVI and d-TAVI patients were matched for numerous baseline parameters, including the degree of AV calcifications, enabling a comparison of these strategies beyond the calcification degree of the AV annulus. Although there were no differences regarding the primary endpoint of procedural success and d-TAVI presented an excellent safety profile with fewer PPIs and lower stroke and pericardial tamponade rates, hemodynamic results were unfavorable compared with b-TAVI in terms of residual significant PVL and rates of significant elevated transvalvular pressure gradients. In this regard, our data are in line with data from previous meta-analyses.21,22 Moreover, we could demonstrate that the effects of d-TAVI do not depend on the degree of valve calcification but rather on the type of THV.
Balloon-expandable THV and d-TAVI. The recently published DIRECTAVI (DIRECT transcatheter Aortic Valve Implantation) randomized trial showed that direct TAVI with a third-generation balloon-expandable THV is non-inferior to conventional TAVI.14 Similarly, we observed that in patients receiving balloon-expandable THV, d-TAVI was associated with shorter procedure duration and radiation exposure, reduced utilization of contrast agent, and reduced rates of balloon postdilation. In addition, there were fewer periprocedural complications and adverse events (eg, PPI, vascular complications, pericardial tamponade, and stroke) accompanied by similar rates of significant PVL and myocardial infarction compared with b-TAVI. These results are also supported by findings from the UK-TAVI registry, which reports d-TAVI to be safe in balloon-expandable THV, as well as those of the recent multicenter ROUTE (Registry Of the Utilization of the Transaortic TAVI Approach Using the Edwards Sapien XT Valve) study, which included 300 patients undergoing transaortic balloon-expandable THV implantation.17,23 However, in the present study, rates of increased postprocedural transvalvular pressure gradients were higher with d-TAVI. The reasons for that finding may be more frequent stent underexpansion in a non-predilated AV apparatus or a more challenging THV placement, especially in heavily calcified AVs.
The reason for the clinical advantage of d-TAVI using balloon-expandable THVs may be due to immediate fixation of AVcalcium by the THV and less application of force when avoiding BAV with consecutive lower rates of stroke and PPI.
Self-expanding THVs and d-TAVI. In our study, patients receiving self-expanding THVs via the d-TAVI approach had higher postimplantation valvular gradients and significantly more PVLs compared with those undergoing b-TAVI. The reasons for this effect remain speculative since no data regarding eccentricity indices or calcium load of the left ventricular outflow tract are available, but may be attributable to underexpansion of nitinol stents in heavily calcified and/or eccentric aortic valves.
Rates of postdilation and postprocedural course with regards to secondary outcome parameters and adverse events were similar in both groups. Recently, Toutouzas et al demonstrated in 171 patients from the randomized DIRECT (Predilatation in Transcatheter Aortic Valve Implantation Trial) a noninferiority of d-TAVI vs b-TAVI in patients undergoing TAVI with a self-expanding THV.15 The authors reported no difference in major vascular complications and rates of PPIs, which is in line with data from our study, but higher postdilation rates in the d-TAVI group. The postdilation rate observed in our study was similar for b-TAVI and d-TAVI. A possible explanation for our findings may be that there was a sample mismatch between our study and the reported sample undercalculation in the DIRECT trial. Further possible–but mostly speculative—explanations include more side effects of postdilation in self-expanding THVs due to more variable force distribution compared with balloon-expandable THVs, significant microlacerations of self-expanding THVs in non-predilated aortic annuli, and the propensity of the more flexible stents in self-expanding THVs to underexpand in non-predilated annuli.
In summary, in this large, PS-matched multicenter study of patients with severe AS, extending over a time span of 7 years, we observed that a significant increase in the number of direct TAVI procedures is supported by its superior safety and non-inferior efficacy profile in balloon-expandable THVs. However, in self-expanding THVs, the advantages and disadvantages of d-TAVI have to be weighed and a clear advantage of d-TAVI with self-expanding THVs was not seen.
Study limitations. The limitations of the present study are its non-randomized design, as it was a large, prospective, all-comers registry database. Nonetheless, the large prospective design and the use of a PS-weighted model allow for data comparison. Data were obtained with TAVI techniques used through the years 2011 and 2017; therefore, further analyses will be necessary in the coming years to address further technical refinements.
Conclusion
In this first GARY analysis of weighted comparison between TAVI with balloon predilation and direct TAVI without balloon predilation, the latter demonstrated a better safety and non-inferior efficacy profile in balloon-expandable valves and displayed both advantages and disadvantages in self-expanding valves. The decision for or against balloon aortic valvuloplasty preceding THV insertion should be based on individual patient characteristics, anatomical factors, and the choice of THV.
Impact on daily practice. In this analysis of a large PS-weighted all-comers registry, specific trends in TAVI implantation technique regarding the utilization of balloon predilation were seen. The safety and efficacy of d-TAVI vs b-TAVI depend on the type of THV implanted; for both balloon-expandable and self-expandable THVs, d-TAVI provides an advantageous (balloon-expandable) or similar (self-expanding) safety profile compared with b-TAVI regarding postoperative complications. However, postinterventional hemodynamics showed higher rates of increased mean pressure gradient for both valve types and more significant PVL in self-expanding THVs, emphasizing the importance of proper patient selection and careful preinterventional evaluation of valve anatomy to identify suitable cases for d-TAVI.
Affiliations and Disclosures
From the 1Department of Internal Medicine, Cardiology, and Angiology, Zollernalb-Klinikum, Abstadt, Germany; 2Department of Cardiovascular Diseases, Campus Benjamin Franklin, Charité—Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, and German Centre for Cardiovascular Research, Berlin (DZHK), Germany; 3Department of General and Interventional Cardiology, Helios Klinikum Erfurt, Germany; 4Institute of Biostatistics and Mathematical Modelling at Goethe University, Frankfurt am Main, Germany; 5German Center for Cardiovascular Research, DZHK, Partner Site Rhine Main, Theodor-Stern-Kai, Frankfurt am Main, Germany; 6Department of Cardiovascular Surgery, University Heart and Vascular Center Hamburg, Hamburg, Germany; 7Sana Klinikum Offenbach, Department of Cardiology, Offenbach, Germany; 8German Society for Thoracic and Cardiovascular Surgery, Langenbeck Virchow Haus, Berlin, Germany; 9Clinic for Thoracic and Cardiovascular Surgery, Herz- und Diabeteszentrum NRW, Ruhr Universität Bochum, Bad Oeynhausen, Germany; 10,IIDepartment of Medicine, University Medical Center Schleswig-Holstein, Lübeck, Germany; 11Medizinische Klinik I, St. Johannes Hospital Dortmund, Germany; 12Department of Cardiac Surgery, Goethe University Hospital, Frankfurt, Germany; 13Department of Cardiology, Robert Bosch Hospital, Stuttgart, Germany; and 14the Department of Cardiovascular Surgery, University Centre Lübeck, Schleswig-Holstein, Germany.
Funding: This work was supported by the German Center for Cardiovascular Research/Deutsches Zentrum für Herz-Kreislauf Forschung (DZHK).
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Schaefer reports lecture fees from Abbott; travel support from Edwards Lifesciences. Dr Bleiziffer reports speaker fees from Medtronic, Edwards Lifesciences, Boston Scientific, and Abbott. Dr Frerker reports travel grants, lecture honoraria, and proctor fees from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Structural. Dr Ensminger is a consultant for Edwards Lifesciences and reports lecture fees from Edwards Lifesciences and Medtronic. Dr Conradi reports fees from Edwards Lifesciences, LivaNova, Boston Scientific, and Microinterventions. The remaining authors report no conflicts of interest regarding the content herein.
Manuscript accepted July 26, 2022.
Address for correspondence: Dr Brunilda Alushi, Department of Cardiology, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin, Hindenburgdamm 20-12200 Berlin, Germany. Email: brunilda.alushi@charite.de
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