C 2010, Wiley Periodicals, Inc. DOI: 10.1111/j.1540-8183.2010.00559.

Aortic Balloon Valvuloplasty: Is There Still a Role in High-risk Patients in the Era of Percutaneous Aortic Valve Replacement?
TAHIR HAMID, M.R.C.P., JONAS EICHHOFER, M.R.C.P., Ph.D., BERNARD CLARKE, B.Sc., M.D., F.R.C.P., F.E.S.C., F.A.C.C., and VAIKOM S. MAHADEVAN, M.R.C.P., M.D.
From the Manchester Heart Centre, Manchester Royal Inrmary, University of Central Manchester, Foundation NHS Trust, United Kingdom

Objectives: To assess procedural and clinical outcomes in adults with severe aortic stenosis (AS) undergoing percutaneous aortic balloon valvuloplasty (PABV), who are considered unsuitable on initial assessment for surgical aortic valve replacement or transcatheter aortic valve implantation (TAVI). Background: Surgical valve replacement provides better outcomes than conservative treatment for patients with severe symptomatic AS; however, patients with multiple comorbidities or hemodynamic instability carry a high operative risk. While TAVI offers an alternative to surgery, not all patients are suitable. This study looks at medium-term outcomes in a series of high-risk patients undergoing PABV. Methods: Pre- and postprocedure aortic valve gradients were measured by catheterization and echocardiography. Patients were assessed for symptomatic benet and clinical outcomes. Results: Over 4 years, 42 patients underwent PABV. Mean clinical follow-up was 8 5.8 months and survival was 63%. Mean echocardiographic aortic valve gradient fell from 84.6 27 mmHg to 51.3 16 mmHg (p < 0.05). In 29% (12/42) patients, PABV was performed as a bridge to denitive AVR. Four had surgical AVR and six had TAVI. Two had successful noncardiac surgery. Four patients died in the periprocedural period and all were in cardiogenic shock. Patients were in New York Heart Association (NYHA) class IV decreased from 60% to 5% postprocedure (p < 0.05). Conclusion: PABV is useful as a palliation or bridge to denitive therapy for treatment of patients with severe AS unsuitable for surgery. It is associated with good medium-term cardiac outcomes and enables some patients to receive denitive therapy. (J Interven Cardiol 2010; :14)

Introduction
Aortic valve replacement (AVR) surgery is the treatment of choice for severe calcied symptomatic aortic stenosis (AS) in adults. Average survival in patients with severe AS and symptoms such as dizziness, heart failure, angina, and syncope is only 23 years and there is a high risk of sudden death.1 Surgical valve replacement promises signicantly better outcomes than conservative treatment with improvement in symptoms
Address for reprints: Tahir Hamid, M.R.C.P., Manchester Heart Centre, Manchester Royal Inrmary, University of Central Manchester Foundation NHS Trust, UK. Fax: 0044-161 232 3335; e-mail: Tahirhamid76@yahoo.co.uk

and survival in this patient group.28 However, patients with multiple comorbidities or hemodynamic instability often carry an unacceptably high operative risk. While transcatheter aortic valve implantation (TAVI) might offer an alternative to surgery for this patient group in the future, it is currently still experimental and not all patients are suitable for this procedure. Percutaneous aortic balloon valvuloplasty (PABV) has long been used as a treatment modality in children and adolescents with valvular AS.5,9 PABV is useful as palliative treatment for symptomatic relief in elderly patients with severe calcied AS who are deemed inoperable.10 While PABV did not show long-term survival benet in patients who had no denitive management,11 it has recently shown in one study, it improved

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1-year survival in this subgroup.12 It can be used as bridge to more denitive surgical replacement in patients who present with hemodynamic compromise13 and patients requiring high-risk percutaneous coronary intervention.14 It has also been shown to reduce the risks of gestation, labor, and delivery in women with severe AS who develop major symptoms during pregnancy.13,1517 TAVI has limitations due to the currently available large prole transfemoral delivery system, and the minimum ileo-femoral vessel diameters required for their use18 and the transapical approach may not be suitable in patients who are in signicant heart failure with other comorbidities. This study looks at the mediumterm outcomes in a series of high-risk adult patients undergoing PABV in a tertiary referral center.

Table 1. Patient and Procedural Characteristics (n = 42) Men Age (Years) Atrial brillation Cardiogenic shock Severe LV systolic dysfunction (EF < 30%) Chronic renal failure Chronic airway disease Previous ischemic heart disease Previous coronary artery bypass surgery Previous percutaneous coronary intervention Underlying malignancy Local Anesthesia General anesthesia Use of temporary pacing wire Urgency of procedure Emergency 24 (57%) 77 12 10 (24%) 07 (17%) 19 (45%) 19 (45%) 4 (10%) 14 (33%) 6 (14%) 7 (17%) 5 (12%) 40 (95%) 02 (5%) 7 (17%) 08 (19%)

Methods
We performed a retrospective analysis of 42 consecutive adult patients with severe AS deemed unsuitable for surgical AVR undergoing PABV. Pre- and postaortic valve gradients and the degree of aortic regurgitation were measured by catheter pullback and transthorcacic echocardiography. Only seven patients had a temporary pacing wire inserted during the procedure. Patients were followed up in outpatients and their clinical outcomes were also analyzed. Emergency valvuloplasty was dened as PABV being performed within 24 hours of hospital admission. Data were analyzed retrospectively by a single unblinded observer. Statistical analysis was performed using Microsoft Excel R and paired t tests. Apart from clinical examination, patients had baseline (preprocedure), postprocedure, and 69 months follow-up transthorcacic echocardiography.

Echocardiographic parameters preprocedure, postprocedure, and at 6-month follow-up are as given in Table 2. Left ventricular ejection fraction at presentation was 28 10% that improved to 35 13% (p < 0.05) postprocedure. Mean transvalvular echocardiography gradient fell from 84.6 27 mmHg to 51.3 16 mmHg (p < 0.0001). Mean peak-to-peak catheter gradient preprocedure was 66.7 27 mmHg, which fell to 28.2 15 mmHg (p < 0.0001). The transcatheter valvular gradients across the aortic valve are shown in Fig. 1. This gure shows the fall in gradients in these patients divided into two groups, based on preprocedural gradients and both groups demonstrated a signicant decrease in gradients postprocedure (p < 0.001). Two patients underwent concurrent PCI. One patient required further PABV after 6 months. Only two patients had more than mild aortic regurgitation postprocedure. Four patients died in the periprocedural period (within 24 hours) and all of them were in cardiogenic shock preprocedure. There were 14 deaths in the follow-up period (12 with noncardiac causes,
Table 2. Transthoracic Echocardiography Data 6 months (n = 23) 40.5 4 62.6 30 70% (26/37)

Results
Forty-two PABV procedures were performed over a 4-year period. Patient demographics and procedural characteristics are shown in Table 1. The retrograde approach was used in all of the procedures with 95% (40/42) having a transfemoral approach while two patients had transbrachial approach due to severe peripheral vascular disease. Seventeen percent (7/42) were in cardiogenic shock requiring inotropic support. Five patients were admitted with troponin-positive acute coronary syndromes.

Variables Mean EF (% SD) Peak gradient (mmHg SD) Mild Moderate AR

P

Preprocedure Postprocedure 28 10 84.6 27 AR Nil 35 13 51.3 16 55% (23/42) 5.4% (2/37)

< 0.05 (as compared to base line).

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ROLE OF AORTIC BALLOON VALVULOPLASTY IN THE CURRENT ERA

Discussion
Surgical AVR is a highly effective therapy for symptomatic severe calcied AS in patients suitable for surgery. While PABV results tend to deteriorate over a 12-month period, the advent of percutaneous AVRs for high-risk patients has resulted in a resurgence of the PABV technique as part of the preparatory stage prior to valve deployment. While TAVI is being developed, there is lack of long-term data for this procedure and currently there are no randomized controlled trials to show its comparability to surgical AVR. Currently, TAVI is not possible in all patients considered unsuitable for a surgical AVR. Moreover in patients who are seriously ill with severe calcied AS, TAVI may still carry a signicant risk of procedural complications including the need for general anesthesia. Hence, there appears to be a twofold role for PABV in the current scenario: As a palliative procedure in patients who are too sick to undergo surgical AVR or TAVI. PABV can serve as bridge to more denitive treatment in the form of surgical AVR or TAVI in particularly high-risk or pregnant patients. In our series, 24% of patients underwent denitive treatment with either surgical AVR or TAVI. While the absence of a control group is a limiting factor for this study, we feel PABV has allowed this highrisk patient group to undergo successful denitive therapy at a lower risk. Emergency PABV is also a useful tool in patients who require noncardiac surgery/general anesthesia. Two of our patients, both of whom were nonagenarians,19 were admitted with neck of femur fracture and following emergency PABV underwent successful noncardiac surgery. The current use of newer Nucleus balloon, which has lesser mobility across the valve on ination due to its dumbbell pattern of ination, may obviate the need for rapid pacing. Patients who suffer from terminal illness with limited life expectancy and severe symptomatic AS might benet from palliative PABV, as a quality of life improvement measure where neither surgical AVR nor TAVI would be offered. Two patients required a brachial procedure due to severe peripheral vascular disease. Percutaneous valve replacement in these patients is still a challenge due to the need of larger bore catheters, and vascular access but transapical approach is a possible

Figure 1. Mean pre- and postprocedural peak-to-peak catheterization gradients. p < 0.01 compared to preprocedure.

one each with acute myocardial infarction and aortic valve endocarditis). Mean clinical follow-up was 8 5.8 months (range 228 months). The mean echocardiographic aortic valve gradient at 6 months follow-up was 62.6 30 mmHg (p 0.05) as compared to baseline. The average in-patient stay was 6 16 days. In 29% (12/42) patients, PABV was performed as a bridge to denitive AVR. Four had successful surgical aortic valve surgery and six had TAVI while a further two are awaiting TAVI. PABV enabled two patients to have successful noncardiac surgery for fracture neck of femur and one to have a successful peripartum outcome. The balloons used ranged from 15 mm to 25 mm in diameter with an average of 4 1.2 balloon inations. Changes in New York Heart Association (NYHA) class pre- and postprocedure are given in Figure 2. Preprocedurally, 60% of the patients were in NYHA class IV, which decreased to 5% postprocedure (p <0.05). The number of patients in NYHA class II increased from 7% preprocedure to 60% postprocedure (p < 0.05).

Figure 2. Symptomatic assessment using New York Heart Association classication.

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alternative. In this study, 95% of the PABV procedures were performed under local anesthetic. Surgical AVR and TAVI require a general anesthetic, increasing the risks in this patient cohort. Of the seven patients presenting with cardiogenic shock and receiving emergency PABV, four died in the periprocedural period reecting the high risk of this presentation. However, there were no cardiac related procedural deaths in patients not in cardiogenic shock suggesting that PABV is a well-tolerated procedure.

Conclusion
PABV can be used as a palliation or bridge to denitive therapy for treatment of patients with severe AS who are poor candidates for surgery. It is associated with good medium-term outcomes in this very highrisk population group and enables some patients to receive denitive therapy in the future.

References
1. Bonow RO, Carabello BA, Chatterjee K, et al. ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (writing Committee to Revise the 1998 guidelines for the management of patients with valvular heart disease) developed in collaboration with the Society of Cardiovascular Anesthesiologists endorsed by the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons. J Am Coll Cardiol 2006;48(3):e1e148. 2. Murphy ES, Lawson RM, Starr A, et al. Severe aortic stenosis in patients 60 years of age or older: Left ventricular function and 10-year survival after valve replacement. Circulation 1981;64(2 Pt 2):II184II188. 3. Kvidal P, Bergstrom R, Horte LG, et al. Observed and relative survival after aortic valve replacement. J Am Coll Cardiol 2000;35(3):747756. 4. Kvidal P, Bergstrom R, Malm T, et al. Long-term follow-up of morbidity and mortality after aortic valve replacement with a mechanical valve prosthesis. Eur Heart J 2000;21(13):1099 1111.

5. Brogan WC, 3rd, Grayburn PA, Lange RA, et al. Prognosis after valve replacement in patients with severe aortic stenosis and a low transvalvular pressure gradient. J Am Coll Cardiol 1993;21(7):16571660. 6. Smith N, McAnulty JH, Rahimtoola SH. Severe aortic stenosis with impaired left ventricular function and clinical heart failure: Results of valve replacement. Circulation 1978;58(2):255264. 7. Freeman RV, Otto CM. Spectrum of calcic aortic valve disease: Pathogenesis, disease progression, and treatment strategies. Circulation 2005;111(24):33163326. 8. Lund O. Preoperative risk evaluation and stratication of long-term survival after valve replacement for aortic stenosis. Reasons for earlier operative intervention. Circulation 1990;82(1):124139. 9. Fratz S, Gildein HP, Balling G, et al. Aortic valvuloplasty in pediatric patients substantially postpones the need for aortic valve surgery: A single-center experience of 188 patients after up to 17.5 years of follow-up. Circulation 2008;117(9):1201 1206. 10. Pedersen WR, Klaassen PJ, Boisjolie CR, et al. Feasibility of transcatheter intervention for severe aortic stenosis in patients >or = 90 years of age: Aortic valvuloplasty revisited. Catheter Cardiovasc Interv 2007;70(1):149154. 11. Lieberman EB, Bashore TM, Hermiller JB, et al. Balloon aortic valvuloplasty in adults: Failure of procedure to improve longterm survival. J Am Coll Cardiol 1995;26(6):15221528. 12. Sack S, Kahlert P, Khandanpour S, et al. Revival of an old method with new techniques: Balloon aortic valvuloplasty of the calcied aortic stenosis in the elderly. Clin Res Cardiol 2008;97(5):288297. 13. Moreno PR, Jang IK, Newell JB, et al. The role of percutaneous aortic balloon valvuloplasty in patients with cardiogenic shock and critical aortic stenosis. J Am Coll Cardiol 1994;23(5):10711075. 14. Aqel RA, Hage FG, Zoghbi GJ. Percutaneous aortic valvuloplasty as a bridge to a high-risk percutaneous coronary intervention. J Invasive Cardiol 2007;19(8):E238E241. 15. Lao TT, Adelman AG, Sermer M, et al. Balloon valvuloplasty for congenital aortic stenosis in pregnancy. Br J Obstet Gynaecol 1993;100(12):11411142. 16. McIvor RA. Percutaneous balloon aortic valvuloplasty during pregnancy. Int J Cardiol 1991;32(1):13. 17. Banning AP, Pearson JF, Hall RJ. Role of balloon dilatation of the aortic valve in pregnant patients with severe aortic stenosis. Br Heart J 1993;70(6):544545. 18. Hanzel GS, ONeill WW. Complications of percutaneous aortic valve replacement: Experience with the Cribier-Edwards percutaneous heart valve. EuroIntervention 2006;1(Supplement A):A3-A8. 19. Chacko S, Mamas M, Nair S, et al. Emergency percutaneous aortic balloon valvuloplasty in a nonagenarian. J Am Geriatr Soc 2009;57(1):185186.

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