Balloon Aortic Valvuloplasty With Same-Setting Complex Percutaneous Coronary Intervention in the TAVR Era: A Case Series

Background. The use of balloon aortic valvuloplasty (BAV) prior to same-setting complex percutaneous coronary intervention (PCI) in patients with severe aortic stenosis (AS) and concomitant severe coronary artery disease (CAD) has not been well studied in the era of transcatheter aortic valve replacement (TAVR). Methods. We reviewed 379 BAVs performed between January 2016 and April 2020 at an academic tertiary-care medical center. Overall, 327 BAVs were performed in the setting of TAVR. Of the remaining 52 BAVs, 20 were performed immediately prior to same-setting complex PCI. We examined the baseline and procedural data, and clinical outcomes of these cases. Results. Mean patient age was 81 ± 9 years and 70% were men. Chronic kidney disease (40%), diabetes mellitus (35%), and atrial fibrillation (35%) were the most prevalent comorbidities. Rotational atherectomy was performed in 75% of cases and Impella device was utilized in 15%. PCI of distal left main coronary artery and proximal left anterior descending coronary artery was performed in 30% and 80% of cases, respectively. Mean contrast volume was 149 ± 61 mL, fluoroscopy time was 37 ± 20 minutes, total skin dose was 2821 ± 1931 mGy, and total area dose was 18651 ± 12090 µGy/m². Rate of in-hospital complications was low, with a 0% mortality and stroke rate. Eighty percent of patients were referred for TAVR; 70% went on to undergo successful TAVR and 10% deferred TAVR due to improvement in symptoms. Conclusions. BAV with same-setting complex PCI is safe and feasible in patients with severe AS and severe CAD awaiting TAVR. 

J INVASIVE CARDIOL 2021;33(6):E479-E482. Epub 2021 May 20.

Key words: aortic stenosis, aortic valve stenosis, atherectomy, balloon aortic valvuloplasty, Impella, percutaneous left ventricular support, rotational atherectomy, transcatheter aortic valve intervention

Performance of coronary artery bypass graft (CABG) surgery at the time of surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis (AS) and concomitant coronary artery disease (CAD) with severe stenoses has served as the standard of care for several decades. With the expanding utilization of transcatheter aortic valve replacement (TAVR) in recent years, treatment of concomitant CAD in adults with severe AS has become a subject of heightened interest. Nearly two-thirds of patients undergoing TAVR have CAD.¹ The 2017 appropriate use criteria for the treatment of patients with severe AS recommend that in high- and intermediate-risk patients with extensive CAD (ie, left main, 3-vessel disease), TAVR alone is typically “rarely appropriate.”² Few data exist on the use of balloon aortic valvuloplasty (BAV) prior to same-setting complex percutaneous coronary intervention (PCI) in patients with complex CAD and severe AS, especially in the TAVR era.^3-8 We examined the presentation and outcomes of the contemporary use of BAV with same-setting complex PCI at an academic tertiary-care medical center.

We reviewed all BAVs performed between January 2016 and April 2020 at Stony Brook University Medical Center. Cases in which BAV was performed prior to same-setting complex PCI were selected. We examined the baseline and procedural data, as well as clinical outcomes of these cases. 

Demographic and baseline medical history data extracted included age, sex, weight, height, body mass index (BMI), left ventricular ejection fraction, prior CABG surgery, prior PCI, prior myocardial infarction, congestive heart failure, atrial fibrillation, chronic obstructive pulmonary disease, peripheral artery disease, diabetes mellitus, and chronic kidney disease. Procedural data extracted included vessel intervened, number of stents, maximal size of valvuloplasty balloon (with pre-and postprocedure aortic valve gradients), anticoagulant use, and presence of rotational atherectomy (with maximal burr size), Impella device (Abiomed) support, transvenous pacer, and right heart catheterization. Contrast amount and fluoroscopy data (ie, fluoroscopy time, total skin dose, and total area dose) were also extracted. Clinical outcomes included in-hospital outcomes (all-cause mortality, stroke, contrast-induced nephropathy, vascular complications, and access-site and non-access site bleeding) and performance of eventual TAVR. This study was approved by our institutional review board. A waiver of consent to use data prospectively was obtained. 

Statistical analysis. Categorical variables are expressed as numbers with percentages, while continuous variables are presented as mean ± standard deviation. 

Between January 2016 and April 2020, a total of 379 BAVs were performed at Stony Brook University Medical Center. Overall, 327 BAVs were performed in the setting of TAVR. Of the remaining 52 BAVs, 20 were performed immediately prior to same-setting complex PCI. The baseline characteristics of the BAV-complex PCI patients are shown in Table 1. Mean patient age was 81 ± 9 years and 70% were men. Chronic kidney disease (40%), diabetes mellitus (35%), and atrial fibrillation (35%) were the most prevalent comorbidities. 

The procedural characteristics are summarized in Table 2. Rotational atherectomy was performed in 75% of cases and Impella device was utilized in 15% (Figure 1). PCI of distal left main coronary artery and proximal left anterior descending coronary artery was performed in 30% and 80% of cases, respectively. Aortic valve mean gradients were checked pre and post BAV in 90% and 65% of patients, respectively. Mean gradients pre and post BAV were 41 ± 20 mm Hg and 20 ± 12 mm Hg, respectively. Mean contrast volume was 149 ± 61 mL, fluoroscopy time was 37 ± 20 minutes, total skin dose was 2821 ± 1931 mGy, and total area dose was 18651 ± 12090 µGy/m².

Rates of in-hospital mortality and stroke were both 0%. Two patients were noted to have a groin hematoma and 1 patient had a postprocedural femoral pseudoaneurysm. Eighty percent of patients were referred for TAVR; 70% went on to undergo successful TAVR within 6 months and 10% deferred TAVR due to improvement in symptoms. 

The major finding of our contemporary study is that BAV followed by same-setting complex PCI is safe and feasible in adults with severe AS and advanced CAD awaiting TAVR. In the TAVR era, there has been a renewed interest in BAV as it has proven to be a useful therapeutic tool for palliation of symptoms, bridge to SAVR or TAVR, and evaluation of response in select high-risk patients with severe AS. The use of BAV to support complex PCI, however, has been a subject of controversy. Older studies examining BAV and concomitant PCI demonstrated significantly higher rates of major adverse cardiac events, with mortality rates as high as 10%-40% and transfusion rates as high as 20%.^3,8 High-risk coronary lesions, however, were typically avoided in these high-risk surgical patients, with nearly 60% of patients having complex PCI deferred.⁷ A more recent study examining the use of same-setting BAV-PCI in the TAVR era has reported lower in-hospital mortality rates of 5%-6% and 1-year mortality rate of approximately 30%, but it is unclear whether these patients underwent complex PCI.⁴ Use of smaller BAV balloons in this case series likely contributed to the lower complication rate. However, despite less aggressive balloon dilation, a 50% reduction in mean aortic gradient was still noted.

Our study reported rotational atherectomy use in 75% and Impella percutaneous left ventricular support in 15% of patients. Furthermore, 30% of patients in our study underwent distal left main coronary artery intervention. Use of rotational atherectomy and Impella during high-risk PCI with BAV has been reported in case reports and small case studies.^9-12 A substudy from the OCEAN (Optimized transCathetEr vAlvular iNtervention) registry¹² examined the use of rotational atherectomy in patients with severe AS and heavily calcified CAD and demonstrated a 100% procedural success rate, with 16% of patients receiving same-session BAV and 16% receiving an intra-aortic balloon pump. Safety and feasibility of orbital atherectomy in patients with severe AS was recently reported, with 12% in-hospital mortality in the absence of BAV.¹³ 

Performance of BAV during PCI potentially permits safe passage of percutaneous left ventricular assist devices through severely stenotic aortic valves that may not otherwise allow passage of bulky devices without dilation. Use of such ventricular support devices may be important in supporting these patients with complex CAD, especially in the setting of reduced left ventricular ejection fraction and/or challenging hemodynamic state. The potential of hemodynamic collapse from reduced flow in a coronary artery following atherectomy or significant hypotension in patients with depressed left ventricular ejection fraction may be ameliorated by dilation of a significant stenosis across the aortic valve with or without placement of a back-up hemodynamic support device.  

Study limitations. Our study has limitations. First, this was a single-center, retrospective, observational analysis, without independent clinical event adjudication and core laboratory assessment of the study angiograms. Second, this study only assessed patients with severe AS and concomitant CAD undergoing simultaneous BAV and complex PCI. Hence, patients with severe AS who underwent PCI without BAV were not captured in this study. 

In this contemporary case series, BAV with same-setting complex PCI is safe and feasible in patients with severe AS and severe CAD awaiting TAVR. As the utilization of TAVR continues to grow worldwide, the percutaneous management of patients with complex CAD and severe AS will also continue to rise. Further studies examining the impact of BAV on outcomes in pre-TAVR patients undergoing complex PCI are warranted. 

From the Division of Cardiovascular Medicine, Department of Medicine, State University of New York at Stony Brook, Stony Brook, New York.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein.

Manuscript accepted November 2, 2020.

The authors report that patient consent was provided for publication of the images used herein.

Address for correspondence: Puja B. Parikh, MD, MPH, Director, Transcatheter Aortic Valve Replacement Program, Division of Cardiology, Stony Brook University Medical Center Health Sciences Center, T16-080, Stony Brook, NY 11794-8160. Email: puja.parikh@stonybrookmedicine.edu