Balloon Aortic Valvuloplasty for Severe Aortic Stenosis as a Bridge to High-Risk Transcatheter Aortic Valve Implantation

ABSTRACT: Objectives. To provide data on feasibility, safety and efficacy of balloon aortic valvuloplasty (BAV) as a bridge to trans-catheter aortic valve implantation (TAVI). Background. There are no data on BAV use as a bridge to TAVI in patients at high risk of peri-procedural complications. Methods. Between June 2007 to May 2009, 83 consecutive patients with symptomatic severe aortic stenosis (48 female, 35 male) aged from 65 to 88 years (mean age 81 ± 5 years) were treated with TAVI. Early hemodynamic and clinical outcomes of patients undergoing palliative BAV before TAVI (BAV Group, n = 43) were compared with those of patients who directly underwent TAVI (no-BAV Group, n = 40). Results. Patients in the BAV group had worse baseline clinical characteristics than those in the no-BAV group, with higher rates of congestive heart failure, New York Heart Association (NYHA) functional class III or IV and a higher EuroSCORE. In the BAV group, significant changes were found after valvuloplasty with regard to NYHA functional class, mean pressure gradient and aortic valve area. Peak-to-peak transvalvular pressure gradient and left ventricular systolic pressure also decreased immediately after BAV. Before TAVI, no differences in either clinical status or hemodynamic data were observed between patients who underwent BAV and those who did not. Conclusions. Bridging to TAVI with BAV is a feasible and reasonably safe approach to offer temporary relief in selected high-risk patients with symptomatic severe aortic stenosis and a high chance of periprocedural complications. J INVASIVE CARDIOL 2010;22:161–166 Key words: degenerative aortic stenosis, transcatheter aortic valve implantation, percutaneous coronary intervention
Degenerative aortic stenosis (AS) is the most common valve disorder in the Western world, with increasing prevalence expected in an aging population.^1–3 Surgical aortic valve replacement (SAVR) is the primary treatment modality recommended for AS regardless of age,^4,5 but physicians are increasingly challenged in finding suitable therapy for elderly patients who are poor candidates for traditional valve replacement surgery. ⁶ Percutaneous balloon aortic valvuloplasty (BAV) was originally proposed as an alternative to cardiac surgery for AS treatment, but it was rapidly neglected secondary to high restenosis rates and lower survival at follow up compared to SAVR. ^7–9 However, some evidence has been reported that BAV might be a reasonable option as a bridge to surgery in adult patients with AS who are at high risk for SAVR. ^10–14 Current guidelines support this statement, assigning to this procedure a Class IIb recommendation. ⁵ The availability of aortic valve prostheses designed to be implanted percutaneously^15,16has raised new interest regarding the opportunity to employ BAV as a bridge to safer transcatheter aortic valve implantation (TAVI) in patients at high risk for periprocedural complications. However, whether this strategy may be appropriate in selected patients at high risk for TAVI-related periprocedural complications is undefined. The present study reports our institutional experience of BAV in high-risk patients with AS who subsequently underwent TAVI with the 18 Fr CoreValve ReValving™ System (CRS, CoreValve-Medtronic, Inc., Minneapolis, Minnesota, CE mark-approved) and reviews the technique, clinical effects and efficacy of the procedure.

Materials and Methods

Patient population and selection. Between June 2007 to May 2009, 83 consecutive patients (48 female, 35 male) aged from 65 to 88 years (mean age 81 ± 5 years) underwent TAVI for symptomatic severe AS and were enrolled in this prospective, single-center, nonrandomized study. Criteria for TAVI included native aortic valve stenosis with aortic valve area < 1 cm2 (< 0.6 cm2/m2) determined by echocardiography, aortic valve annulus diameter 20 mm and 27 mm, sinotubular junction 43 mm, diameter of the iliac and femoral arteries 7 mm, logistic EuroSCORE > 20%, contraindication to surgery because of concomitant comorbid conditions assessed and agreed to by both an independent cardiologist and a cardiovascular surgeon. Of the 83 enrolled patients, 43 (52%) presented characteristics deemed high risk for TAVI-related periprocedural complications and underwent palliative BAV before TAVI with the aim of improving their hemodynamic and clinical conditions. The criteria for BAV as a “bridge” to TAVI included severe AS with < 2+ aortic regurgitation, New York Heart Association (NYHA) class III, severe ventricular dysfunction defined as left ventricular ejection fraction (LVEF) < 30%, pulmonary arterial hypertension, mitral regurgitation (MR) > 2+ and/or single-vessel coronary stenosis with indication for percutaneous coronary intervention (PCI). Pre-BAV screening included both angiographic and hemodynamic evaluations and transthoracic echocardiography (TTE) recording LVEF, systolic pulmonary artery pressure, aortic valve annulus diameter and additional mitral and aortic valve regurgitation. The study was conducted according to the Declaration of Helsinki. The local medical ethics committee approved the protocol, and written informed consent was obtained from every patient and their closest relatives. The authors had full access to the data and take full responsibility for their integrity. All authors have read and agreed to the manuscript as written. BAV procedure. Patients selected for BAV underwent right and left cardiac catheterization with local anesthesia. After coronary angiography, aortography was performed with a 5 Fr pigtail catheter. Using a left anterior oblique projection, the aortic valve was crossed with an AL1 7 Fr catheter and a 0.035 inch movable straight guidewire (Johnson & Johnson - Cordis Unit, Cordis Europe, NV). Left ventricular systolic, end-diastolic pressures and peak-to-peak gradients were recorded. Then, a 300 cm Amplatz super-stiff guidewire with 6 cm precurved soft tip was positioned in a stable and safe position in the left ventricle and valve enlargement was performed by inflating an undersized balloon for 5 to 10 seconds a maximum of three times (14–16 mm in small valves, 18–20 mm in large valves) with a mean annulus-to-balloon diameter ratio of 0.5. A TyShack Balloon Catheter (Numed Canada Inc./BVM Medical Ltd.) with a 9 Fr shaft was employed for this purpose. Arterial accesses were sealed using percutaneous stitches with a Proglide 6 (Abbott Vascular, Abbott Park, Illinois). All patients underwent TAVI after a mean of 59 ± 57 days (median 35 days). Details on the TAVI procedure have been described previously. ¹⁷Follow up, data collection and definitions. In-hospital follow up consisted of vital parameters and renal function monitoring and serial TTE. Additional clinical and echocardiographic follow up was planned at 30 days following TAVI. All clinically relevant baseline and follow-up variables were recorded on case report forms and prospectively entered into a dedicated database. Clinical events were adjudicated by an independent clinical events committee. Device success was defined as stable placement of the prosthesis and function as assessed by angiography and echocardiography. For insights on the procedural and early outcome after TAVI, the occurrence of major adverse cerebrovascular and cardiovascular events (MACCE) was assessed at 48 hours and 30 days following prosthesis implantation. MACCE were defined as the composite of death from any cause, myocardial infarction, cardiac tamponade, stroke, urgent or emergency conversion to surgery or BAV, emergency PCI, cardiogenic shock, endocarditis, aortic dissection or major bleeding. Myocardial infarction was defined as creatinine kinase-MB enzyme elevation 3 times the upper limit of normal. Major bleeding was defined as bleeding associated with a hemoglobin decrease of > 5 g/dL (or a hematocrit decrease of 15%). Statistical analysis.Continuous variables were analyzed for a normal distribution with the Shapiro-Wilk test. Continuous variables following a normal distribution are presented as mean ± standard deviations and were compared using the Student’s unpaired or paired t-test, as appropriate. Variables not following a normal distribution are expressed as median (interquartile range) and were compared using the Mann-Whitney Rank Sum test or Friedman’s test, as appropriate. Categorical variables are presented as counts and percentages and were compared with the chi-square test when appropriate (expected frequency > 5). Otherwise, Fisher’s exact test was used. Differences were considered statistically significant for p < 0.05. All data were processed using the Statistical Package for Social Sciences, version 15 (SPSS, Inc., Chicago, Illinois).

Results

Patients who underwent staged BAV and TAVI (n = 43) had worse baseline clinical characteristics than those who did not (n = 40). In fact, they were more likely to present with congestive heart failure (65% vs. 43%; p = 0.039), higher EuroSCORE (31 ± 17 vs. 24 ± 11; p = 0.027) and NYHA functional class III or IV (100% vs. 67%; p < 0.001), as shown in Tables 1 and 2. Mean procedure and fluoroscopic times for BAV were 49 ± 15 and 10 ± 6 minutes, respectively. Forty-two procedures (98%) resulted in no increase or only one grade increase in aortic regurgitation, while 1 (2%) resulted in more than one grade increase in insufficiency. Procedural and early outcome after BAV. This patient developed acute aortic regurgitation as a result of left coronary cusp perforation and was managed with furosemide, systemic vasodilators and TAVI 5 days later. The perioperative course was uneventful and improved functional status was observed at discharge. Three patients (7%) experienced left bundle branch block and 1 patient (2%) had transient complete atrioventricular block that did not require permanent pacemaker implantation. No other complications (e.g., calcium or other embolic phenomena, cardiac tamponade or left ventricular perforation) occurred as a consequence of BAV among the other patients. Fourteen of them (33%) underwent PCI immediately after BAV. Echocardiographic and hemodynamic measurements obtained before and after BAV, as well as those obtained before TAVI, are summarized in Table 2. Mean NYHA functional class declined from III–IV to I–II in 24 patients (56%) after BAV (p < 0.001). This benefit was sustained in 22 of them (92%) at the time of TAVI. Significant changes were found after BAV in terms of peak pressure gradient, mean pressure gradient and aortic valve area as assessed by echocardiography (p < 0.001 for all the comparisons). Invasive measurements such as peak-to-peak transvalvular pressure gradient, left ventricular systolic pressure and mean pulmonary artery pressure also significantly decreased immediately after BAV (p < 0.001 for all the comparisons). Post-ischemic and functional MR ≥ 2+ were present in 12 and 11 patients before BAV, respectively. After BAV, a ≥ 1+ decrease in MR was observed in 2 patients with post-ischemic MR and 7 patients with functional MR (17 vs. 64%; p < 0.001). Benefits in terms of aortic valve area gain, peak-to-peak pressure gradient and left ventricular systolic pressure were substantially sustained after 59 ± 57 days, the mean delay between BAV and TAVI. Systolic pulmonary artery pressure, LVEF and renal function did not significantly change after BAV. Immediate and early outcome after TAVI. Baseline echocardiographic and hemodynamic measurements obtained in patients who underwent TAVI alone were compared with those obtained in BAV patients at the time of TAVI and are shown in Tables 1 and 2. Importantly, no differences in NYHA functional status, echocardiographic or hemodynamic data were observed prior to TAVI between patients who underwent BAV and patients who did not. This observation supports the understanding that BAV partly leveled the baseline differences among groups by stabilizing the clinical and hemodynamic conditions of those patients with a potential for higher TAVI-related periprocedural complications. Acute device success was achieved in 78 patients (94%). In the BAV group, a too-high placement of the prosthesis in a patient with an angulated aorta resulted in 3+ aortic regurgitation and needed to be corrected by implantation of a second CoreValve prosthesis (valve-in-valve technique), as reported elsewhere. ¹⁸ In the same group, other causes for an additional 3 cases of device failure were low implantation (managed with successful replacement), prosthesis embolization (managed with the implantation of 2 consecutive valves) and failed release. Another case of failed release of the prosthesis occurred in the no-BAV group. MACCE within 48 hours after implantation were observed in 4 patients (9.3%) in the BAV group and 5 patients (12.5%) in the no-BAV group (p = 0.73), as summarized in Figure 1. Both groups experienced similar clinical, echocardiographic and hemodynamic improvements following TAVI (Table 3). NYHA class was I–II in 95% of patients in the BAV group and 97% of patients in the no-BAV group (p = 1.00). Peak-to-peak aortic transvalvular gradient, as assessed in the catheterization laboratory after the procedure, and the estimated aortic valve area significantly improved and were not significantly different between the groups after TAVI. Mean pressure gradients were also clearly reduced in both groups immediately after CRS implantation and this benefit was sustained at 30 days. Intravalvular aortic regurgitation was absent in both groups after the procedure. Consistent with the higher EuroSCORE observed among patients who underwent BAV, the mortality rate at 30 days was lower in patients who underwent TAVI alone, even if this difference was not statistically significant (2.5% vs. 11.6%; p = 0.20) as a reflection of a power issue. In the BAV group we observed 2 cardiac deaths at 3 and 8 days for cardiac tamponade caused by temporary pacemaker wire perforation and cardiogenic shock, respectively; the other deaths were not related to the procedure (acute respiratory failure, gastrointestinal bleeding and hemorrhagic stroke). Conversely, the only death in the no-BAV group was caused by cardiac tamponade due to perforation of the left ventricle by the stiff guidewire. Full details on the deceased patients are shown in Table 4. No other MACCE were reported in the two groups within the first 30 days after TAVI. BAV outcomes in patients who did not undergo TAVI.In the study period, BAV was also performed uneventfully in 20 patients who did not undergo TAVI. Of these, 15 (75%) are on a waiting list for TAVI, 3 (15%) refused TAVI due to a marked improvement of their clinical status and 2 patients (10%) died at 35 and 49 days from BAV, respectively, the first one due to an ischemic stroke and the second due to an unknown cause.

Discussion

The present study demonstrated that in patients with AS, a strategy of staging BAV before TAVI in selected patients at high risk for periprocedural complications is feasible, effective and associated with favorable early outcomes following TAVI. Importantly, these outcomes are not inferior to those observed in patients with AS who directly undergo TAVI, despite worse baseline clinical, echocardiographic and hemodynamic conditions observed prior to the execution of BAV. AS is the most frequent expression of valvular heart disease in western countries. ^1,2 Despite the proven efficacy of SAVR, this procedure still carries high operative mortality and morbidity in the growing population of patients at high risk because of age and comorbidities. This set the stage for the emergence of less invasive techniques. ^19,20 Percutaneous aortic valvuloplasty was developed as a nonsurgical option by Cribier et al in 1985. ⁷ Despite a relatively modest improvement in valve function, a degree of functional improvement of short duration is common after the procedure. Then, the benefit declines and generally disappears after a few months because of valve restenosis. ^9,16,21 Moreover, some concerns have been advocated because of high rates of periprocedural complications with BAV. In the National Heart, Lung and Blood Institute (NHLBI) Balloon Valvuloplasty Registry, a survey reporting acute and late outcomes of 674 patients undergoing BAV, the periprocedural mortality rate was 3%, the rate of cerebrovascular events was 2% and the need for emergency conversion to surgery was 1%.²¹ The most common issues associated with BAV were vascular complications at the puncture site. ²¹ Based on these concerns, current guidelines consider BAV a reasonable palliative option for patients in whom SAVR cannot be performed because of serious comorbid conditions and assign a weak recommendation for BAV as a bridge to surgery in hemodynamically unstable patients with AS who are at high risk for SAVR. ⁵ Small experiences of SAVR after bridge BAV were reported with favorable results, ^10–14 while no data are available on bridging to TAVI, which is a relatively new technique. The results attributed to TAVI are strongly influenced by the selection strategy and patients with more comorbidities and/or hemodynamic instability are likely to have a more critical early post-operative period.^22,23 Based on these assumptions we tested the hypothesis that staging BAV before TAVI may be a safe and effective option for reducing the rates of complications in patients at high risk. BAV was performed in 43 patients with poor functional status (100% in NYHA class III or IV), high risk of periprocedural complications (mean logistic EuroSCORE 35%) and a mean peak-to-peak gradient > 70 mmHg. Acute procedural results were a mean increase of aortic valve area from 0.50 to 0.66 cm2 and a parallel reduction of pulmonary artery pressure, peak-to-peak aortic valve gradient and MR. Also, the majority of patients experienced significant symptomatic improvement. Importantly, these early results were partially sustained at a mean of 59 days pending TAVI. As a consequence, although these patients originally presented with worse NYHA class, mean pressure gradient and aortic valve area than those who did not undergo BAV, clinical, hemodynamic and echocardiographic measurements were similar between the BAV and no-BAV groups at the time of TAVI. This may represent a possible explanation for the similar periprocedural MACCE rates observed in these populations, despite a higher potential for acute complications in the BAV group. This study was not designed to investigate the superiority of bridge BAV over direct TAVI in reducing the rates of in-hospital complications and early mortality in high-risk patients because only a randomized comparison can provide the evidence for supporting this hypothesis. Importantly, clinical outcomes of patients undergoing staged BAV and TAVI were not superior to those previously reported for direct TAVI. ^17,24 It is intuitive that in order to advocate BAV prior to TAVI, there must be either a symptomatic, hemodynamic or mortality benefit to offset the potential risk of a second procedure, which might outweigh or even exceed the benefit previously described, especially if applied unselectively. However, an issue that emerges from this study is that a careful selection of patients who are more likely to benefit from BAV may allow them to undergo TAVI in better clinical and hemodynamic conditions, without the significantly increased risk associated with BAV. We observed only 1 case of left coronary cusp perforation with aortic regurgitation successfully managed with medical therapy and TAVI and 4 cases of arrhythmic disorders. No deaths, embolic phenomena, cardiac tamponade or left ventricular perforations occurred as a consequence of BAV in our series. These results compare very favorably with those of the pivotal registries on BAV^,21,25 reflecting more advanced standards and protocols for the procedure and the benefit associated with the use of smaller catheters, undersized balloon, shorter inflation times and closure devices for arterial hemostasis. Of note, we observed higher mortality rates in patients who underwent staged BAV and TAVI at 30 days. In-depth analysis of the mortality patterns reveals that their high risk was anticipated by their mean predicted mortality rate of 43% by the EuroSCORE, with 2 patients presenting with a EuroSCORE > 65%. This finding corroborates the understanding that aside from acute device and procedural success, the EuroSCORE remains one of the most powerful determinants of early mortality in patients treated for severe AS. ²⁶ An emerging concept is that in elderly and frail patients, such as those undergoing palliative TAVI, operative outcomes should not only take the improvement of life expectancy and survival rate into account, but also the improved comfort in daily life. ²7 Our criteria for BAV were planned ad hoc but were based on several assumptions. First, NYHA functional status has been proven to be an independent predictor of improved probability of survival following BAV, ²⁸ and similar figures are likely to be applied for other transaortic procedures such as TAVI. One advantage of BAV in patients selected for TAVI is the potential to provide substantial relief of their worsening symptoms that will enable them to withstand the necessary technical delay before the intervention. Second, pulmonary arterial hypertension in patients with severe AS is often associated with left ventricular dysfunction and/or severe MR.²⁹ Pulmonary hypertension and severe ventricular dysfunction are also associated with a high risk of mortality in patients undergoing surgery. ²⁶ BAV can help to identify patients who are likely to recover from pulmonary arterial hypertension following TAVI and can thus have an impact on their prognosis. Finally, improvement in MR following BAV or SAVR has been described by several authors. ^30–34 American guidelines recommend SAVR as the treatment of choice in patients with severe aortic valve stenosis and functional MR with undamaged leaflets. ⁵Although appealing, the concept of reducing the degree of functional MR by reducing the afterload with TAVI needs to be proven. However, BAV may aid in identifying patients with reversible functional MR among those needing intervention on both valves. Importantly, among patients undergoing BAV in our study, 64% of those with functional MR benefited from BAV versus only 17% of those with post-ischemic MR. Nevertheless, these findings need to be confirmed by larger studies.

Conclusion

In conclusion, bridging to TAVI with BAV is a feasible and reasonably safe approach to offer temporary relief in selected high-risk patients with symptomatic severe degenerative aortic stenosis and an elevated risk of periprocedural complications. Under the right circumstances, BAV can be utilized as part of a complex therapy aimed at prolonging life.

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From the *Department of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy, and the †ETNA Foundation, Catania, Italy. Disclosures: This Study was supported by a research grant provided by Associazione Cuore e Ricerca, Catania, Italy. Dr. G. Ussia is a physician proctor for the CoreValve ReValving® Inc. None of the other authors have conflicts of interest to report. Manuscript submitted October 7, 2009, provisional acceptance given November 3, 2009, final version accepted January 19, 2010. Address for correspondence: Davide Capodanno, MD, Ferrarotto Hospital, via Citelli 6, 95124 Catania, Italy. E-mail: dcapodanno@gmail.com