Balloon Aortic Valvuloplasty in the Transcatheter Aortic Valve Replacement Era

Anirudh Kumar, MD; David Paniagua, MD; Ravi S. Hira, MD; Mahboob Alam, MD; Ali E. Denktas, MD; Hani Jneid, MD

J Invasive Cardiol. 2016;28(8):341-348.

Abstract and Introduction

Abstract

Background. The introduction of transcatheter aortic valve replacement (TAVR) has renewed interest in balloon aortic valvuloplasty (BAV) for severe aortic stenosis (AS). It is unclear whether technical advances and increased operator experience associated with TAVR development have resulted in improved BAV outcomes. We performed a systematic review encompassing all published BAV studies and examined the evolution in indications, outcomes, and complications of BAV procedures since its inception.

Methods. A literature search from 1986 through June 2013 was conducted for all studies reporting BAV outcomes. Studies with <50 BAV procedures were excluded. BAV outcomes and complications were compared in studies enrolling patients in the early/pre-TAVR and contemporary/TAVR periods (before vs after 2005).

Results. Twenty-seven studies representing 4123 patients were included. In the contemporary era, BAV was performed as a bridge to TAVR in 23.4% of patients. Significant and comparable improvement in transaortic valvular gradients, aortic valve area, and cardiac output following BAV were observed in both time periods. There was, however, a significant reduction in procedural death (1.5% vs 2.9%; P<.01), in-hospital mortality (4.6% vs 8.5%; P<.001), and major vascular complications (4.0% vs 10.2%; P<.001) associated with BAV procedures in the contemporary/TAVR era.

Conclusion. BAV is increasingly used as a bridge to TAVR, continues to impart significant hemodynamic improvement in patients with severe AS, and has an improved safety profile in the contemporary era.

Introduction

Aortic stenosis (AS) is currently the most common valvular heart disease in the elderly, with a prevalence of moderate to severe AS in 2.8% of adults 75 years or older.^[1] Without treatment, AS is rapidly progressive with an average survival as low as 1–3 years after symptom onset.^[2–5] In the United States, only ~40% of patients with severe AS will undergo either surgical or transcatheter aortic valve replacement (TAVR).^[1] Surgical aortic valve replacement (SAVR) has been the gold-standard treatment for symptomatic patients for decades and is associated with low operative mortality in patients without significant comorbidities.^[6–10] In current clinical practice, many patients present with numerous medical comorbidities and advanced age, which make them prohibitive or high risk for SAVR.^[3] With an aging population, the prevalence of degenerative AS will continue to impose an increasing burden on the health-care system, requiring alternative forms of treatment for high-risk patients.^[11]

Percutaneous balloon aortic valvuloplasty (BAV), first clinically introduced by Cribier in 1986, was initially proposed as a therapeutic option for non-operative patients with severe AS.^[12] Although immediate postprocedural hemodynamic parameters demonstrated modest but consistent improvement, high procedural mortality rate, high complication rate, and limited impact on long-term survival driven by temporary relief of the stenosis tempered the initial enthusiasm for the procedure.^[13–15] As a result, previous American College of Cardiology/American Heart Association (ACC/AHA) guidelines recommended BAV as a possibly-reasonable therapy (class IIb) to be used as a bridge to surgery in hemodynamically unstable AS patients who are at high risk for SAVR, or for palliation in AS patients in whom AVR cannot be performed because of serious comorbidities.^[16]

TAVR has emerged as a definitive therapy for patients with severe AS who are at prohibitive or high surgical risk.^[3,17–18] With the advent of TAVR, the development of novel devices, and technical improvements, a resurgence in the use of BAV has been observed. In the current report, we have performed a systematic literature review and pooled analyses of all published BAV studies aiming to examine changes in the indications, outcomes, and complications of BAV in the early/pre-TAVR and contemporary/TAVR eras.

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Next Section

Abstract and Introduction
Methods
Results
Discussion
Conclusion
References

Table 1. Summary of the included studies.
	Lead Author	Period of Enrollment	Year of Publication	Study Design	Participating Sites	Region	Population Size (n)	BAVs (n)
1	Letac et al	Sep 1985 - Feb 1987	1988	Registry	Single center	Europe	218	218
2	Kuntz et al	Dec 1985 - Apr 1989	1991	Registry	Single center	USA	205	205
3	Acar et al	Feb 1986 - May 1987	1988	Registry	Single center	Europe	56	56
4	Block et al	Feb 1986 - Aug 1987	1988	Registry	Single center	USA	90	90
5	Dorros et al	July 1986 - Dec 1988	1990	Registry	Multicenter	USA	149	149
6	Ferguson et al	Oct 1986 - Jan 1989	1990	Registry	Single center	USA	68	73
7	Lieberman et al	Nov 1986 - Apr 1991	1995	Registry	Single center	USA	165	165
8	Kastrup et al	Dec 1986 - Sep 1990	1994	Registry	Multicenter	Europe	137	137
9	Holmes et al	Undisclosed	1989	Registry	Single center	USA	88	88
10	Eltchaninoff et al	Jan 1989 - June 1991	1995	Registry	Single center	Europe	86	86
11	Klein et al	Sep 1989 - Mar 2005	2006	Registry	Single center	USA	78	83
12	Kapadia et al	Jan 1990 - June 2005	2010	Retrospective cohort	Single center	USA	90	99
13	Agarwal et al	July 1994 - June 2002	2005	Retrospective cohort	Single center	USA	212	282
14	Sakata et al	Apr 1998 - Sep 2000; Jan 2001 - Mar 2004	2005	Retrospective cohort	Single center	USA	71	71
15	Shareghi et al	Jan 2000 - Jan 2006	2007	Registry	Single center	USA	80	104
16	Cubeddu et al	Jan 2000 - Dec 2006	2009	Retrospective cohort	Single center	USA	157	157
17	Saia et al	Jan 2000 - Jan 2010	2013	Registry	Single center	Europe	415	415
18	Elmariah et al	Jan 2001 - July 2007	2011	Registry	Single center	USA	281	281
19	Yong et al	Jan 2003 - July 2007	2009	Retrospective cohort	Single center	USA	82	82
20	Khawaja et al	Mar 2003 - May 2010	2013	Registry	Multicenter	Europe	423	423
21	Cockburn et al	Jan 2004 - Jan 2010	2012	Registry	Single center	Europe	54	54
22	Don et al	Dec 2004 - Dec 2008	2010	Retrospective cohort	Single center	USA	111	111
23	Sack et al	Apr 2005 - July 2007	2008	Registry	Single center	Europe	75	72
24	Kefer et al	Jan 2006 - Apr 2011	2013	Retrospective cohort	Single center	Europe	151	151
25	Ben-Dor et al	Jan 2006 - May 2011	2012	Retrospective cohort	Single center	USA	472	538
26	Spargias et al	Dec 2006 - Jan 2008	2009	Registry	Single center	Europe	45	50
27	Daly et al	Aug 2008 - Nov 2010	2012	Registry	Single center	Europe	64	64

BAV = balloon aortic valvuloplasty.

Table 2. Characteristics of patients who underwent balloon aortic valvuloplasty in the early/pre-transcatheter aortic valve replacement (TAVR) and contemporary/TAVR eras.
	Overall	Early BAV Experience	Contemporary BAV Experience	P-Value
Total patients (n)	4123	2231	1892	NA
Mean age (years)	79.8 ± 9.5	79.0 ± 9.9	80.8 ± 9.1	.20
Male	44.9%	43.0%	47.1%	.01
Baseline risk characteristics
Hyperlipidemia	56.1%	53.5%	58.7%	.04
Hypertension	74.0%	59.5%	82.0%	<.01
Diabetes mellitus	27.9%	22.4%	31.6%	<.01
Ejection fraction <35%	26.2%	24.8%	27.9%	.16
Chronic kidney disease	43.8%	25.9%	55.9%	<.01
Peripheral vascular disease	30.4%	25.5%	33.3%	<.01
Chronic obstructive pulmonary disease	23.7%	19.0%	26.8%	<.01
Prior stroke	16.4%	15.2%	17.2%	.21
Prior myocardial infarction	25.4%	28.4%	23.9%	.11
Prior coronary artery bypass graft	19.4%	20.2%	18.9%	.44
Clinical presentation
Congestive heart failure	88.8%	87.4%	92.2%	<.01
Stage IV	55.7%	52.7%	57.2%	.08
Angina	25.7%	30.9%	10.5%	<.01
Syncope	18.9%	20.5%	12.9%	<.01
Cardiogenic shock	6.9%	7.7%	6.3%	.25
Procedural indications
Excessive surgical risk	76.7%	86.9%	65.6%	<.01
Bridge to SAVR	7.1%	3.4%	11.0%	<.01
Bridge to TAVR	11.2%	0.0%	23.4%	<.01
Patient preference	5.0%	9.7%	0.0%	<.01
Procedural characteristics
Total procedures (n)	4304	2344	1960	NA
Retrograde access	95.1%	92.6%	95.6%	<.01
Rapid pacing	33.1%	0.1%	84.9%	<.01
Single balloon	92.6%	83.6%	100%	<.01

Data provided as number, mean ± standard deviation, or percentage.

Table 3. Comparison of hemodynamic outcomes and procedural complications among patients who underwent balloon aortic valvuloplasty in the early/pre-transcatheter aortic valve replacement (TAVR) and contemporary/TAVR eras.
Study Parameter	N	Overall	Early BAV Experience	Contemporary BAV Experience	P-Value
BAV outcomes
Pre-peak transaortic valve gradient (mm Hg)	2544	67.9 ± 27.0	68.0 ± 27.4	67.7 ± 26.6	<.05*
Post-peak transaortic valve gradient (mm Hg)		34.4 ± 18.0	31.0 ± 17.8	39.4 ± 18.3	<.05*
Pre-mean transaortic valve gradient (mm Hg)	3610	50.3 ± 20.3	51.6 ± 19.4	49.1 ± 21.1	<.05*
Post-mean transaortic valve gradient (mm Hg)		24.6 ± 13.0	24.7 ± 12.1	24.5 ± 13.7	<.05*
Pre-aortic valve area (cm²)	3999	0.6 ± 0.2	0.6 ± 0.2	0.6 ± 0.2	<.05*
Post-aortic valve area (cm²)		1.0 ± 0.3	1.0 ± 0.3	0.9 ± 0.3	<.05*
Pre-cardiac output (L/min)	2315	4.1 ± 1.3	4.1 ± 1.3	4.3 ± 1.3	<.05*
Post-cardiac output (L/min)		4.5 ± 1.6	4.6 ± 1.6	4.4 ± 1.5	<.05*
Pre-systolic blood pressure (mm Hg)	1481	122.4 ± 27.8	122.0 ± 25.7	123.0 ± 30.9	<.05*
Post-systolic blood pressure (mm Hg)		128.5 ± 28.2	125.2 ± 26.5	133.6 ± 30.6	<.05*
BAV complications
Procedural death	3913	2.2%	2.9%	1.5%	<.01
In-hospital mortality	2420	7.1%	8.5%	4.6%	<.01
Major vascular complications	3548	7.0%	10.2%	4.0%	<.01
Myocardial infarction	3201	0.8%	0.8%	0.7%	.73
Stroke	3483	1.1%	1.2%	1.1%	.91
Severe aortic insufficiency	3106	1.1%	1.1%	1.1%	.94
Cardiac tamponade	3201	0.9%	0.8%	0.9%	.85

*P<.05 for all comparisons between pre-BAV and post-BAV hemodynamic outcomes at all investigated time points (overall, early/pre-TAVR era, and contemporary/TAVR era. BAV = balloon aortic valvuloplasty; TAVR = transcatheter aortic valve replacement.