International Journal of Cardiology xxx (2012) xxx–xxx

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International Journal of Cardiology

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Clinical outcome and quality of life in octogenarians following transcatheter aorticvalve implantation (TAVI) for symptomatic aortic stenosis

Antonio Grimaldi a,⁎, Filippo Figini a, Francesco Maisano a, Matteo Montorfano a, Alaide Chieffo a,Azeem Latib a, Federico Pappalardo a, Pietro Spagnolo b, Micaela Cioni a, Anna Chiara Vermi a,Santo Ferrarello a, Daniela Piraino a, Valeria Cammalleri a, Enrico Ammirati a, Francesco Maria Sacco a,Iryna Arendar a, Egidio Collu a, Giovanni La Canna a, Ottavio Alfieri a, Antonio Colombo a

a Cardiovascular and Thoracic Department, San Raffaele Scientific Institute and Università Vita-Salute, Milan, Italyb Cardiovascular Prevention Centre, San Raffaele Scientific Institute and Università Vita-Salute, Milan, Italy

⁎ Corresponding author. Tel.: +39 0226437124.E-mail address: grimaldi.antonio@hsr.it (A. Grimald

0167-5273/$ – see front matter © 2012 Elsevier Irelandhttp://dx.doi.org/10.1016/j.ijcard.2012.09.079

Please cite this article as: Grimaldi A, et al,tation (TAVI) for symptomatic aortic steno

a b s t r a c t

a r t i c l e i n f o

Article history:

Received 30 September 2011Received in revised form 14 May 2012Accepted 15 September 2012Available online xxxx

Keywords:TAVIAortic stenosisQuality of life

Objective: TAVI is the alternative option in pts with AS deemed ineligible for surgery. Although mortality andmorbidity are measures to assess the effectiveness of treatments, quality of life (QOL) should be an additionaltarget. We assessed clinical outcome and QOL in octogenarians following TAVI.Design: All octogenarians with a risk profile considered by the Heart Team to be unacceptable for surgeryentered in this registry. QOL was assessed by questionnaires concerning physical and psychic performance.Patients: A hundred forty-five octogenarians (age: 84.7±3.4 years; male: 48.3%) underwent TAVI for AS(97.2%) or isolated AR (2.8%). NYHA class: 2.8±0.6; Logistic EuroScore: 26.1±16.7; STS score: 9.2±7.7.Echocardiographic assessments included AVA (0.77±0.21 cm2), mean/peak gradients (54.5±12.2/88±19.5 mmHg), LVEF (21%=EF≤40%), sPAP (43.1±11.6 mmHg).

Interventions: All pts underwent successful TAVI using Edward-SAPIEN valve (71.2%) or Medtronic CoreValve(28.8%).Main outcome measures: Rates of mortality at 30 days, 6 months and 1 year were 2.8%, 11.2% and 17.5%.Results: At 16-month follow up, 85.5% survived showing improved NYHA class (2.8±0.6 vs 1.5±0.7;pb0.001), decreased sPAP (43.1±11.6 mmHg vs 37.1±7.7 mmHg; pb0.001) and increased LVEF in thosewith EF≤40% (34.9±6% vs 43.5±14.4%; p=0.006). Concerning QOL, 49% walked unassisted, 79% (39.5%among pts ≥85 years) reported self-awareness improvement; QOL was reported as “good” in 58% (31.4%among pts ≥85 years), “acceptable according to age” in 34% (16% among pts ≥85 years) and “bad” in 8%.Conclusion: TAVI procedures improve clinical outcome and subjective health-related QOL in very elderlypatients with symptomatic AS.

© 2012 Elsevier Ireland Ltd. All rights reserved.

1. Introduction

Changing clinical epidemiology in patients with valvular heartdisease have brought challenges for cardiologists and cardiacsurgeons alike. The definition of ‘elderly’ population in the cardiologyliterature has evolved: initially >70 years, then >75 years [1], now>80 years of age. Life expectancy and quality of life (QOL) of the elderlycontinue to expand at the cost of an increasing prevalence of cardiovas-cular conditions [2–5].

Aortic stenosis (AS) is the most common form of valvular heartdisease predominatly affecting the elderly (wich are very often highrisk candidates for surgical aortic valve replacement (AVR), stillconsidered as the gold standard treatment [6,7]. The alternatives

i).

Ltd. All rights reserved.

Clinical outcome and qualitysis, Int J Cardiol (2012), http

percutaneous approaches to the management of symptomatic AS inhigh-risk patients have become more attractive and raised profoundinterest in recent years. The superiority of transcatheter aortic valveimplantation (TAVI) compared with medical therapy for patientsdeemed unfit for surgery has been recently established by the“Placement of AoRTic TraNscathetER Valve” (PARTNER) Trial [8] andpreliminary randomized data in high-risk patients have confirmedthat TAVI is non-inferior to AVR in terms of a safety and effectiveness[9]. This finding will probably lead to an exponential increase in TAVIprocedures over the next decade. Although mortality and morbidityare typical outcome measures used to assess the effectiveness ofvarious treatments, QOL should be an additional target and a majorexpectation for this elderly patient's profile [10–12].

Purpose of the study was therefore to assess clinical outcomes ofoctogenarians following TAVI procedure, with a special emphasis onsymptoms, echocardiographic assessment and QOL of very elderlypatients (included those ≥85 years).

of life in octogenarians following transcatheter aortic valve implan-://dx.doi.org/10.1016/j.ijcard.2012.09.079

Table 2Clinical and echocardiographic characteristics of population study.

Variable Mean±SD (%)

N 145Age (years) 84.7±3.4Gender distribution (M) 70 (48.3)

2 A. Grimaldi et al. / International Journal of Cardiology xxx (2012) xxx–xxx

2. Material and methods

All octogenarians with a risk profile considered by the Heart Team to be unaccept-able for surgery entered in this prospective registry.

2.1. Patient evaluation

All the patients have been evaluated by a multidisciplinary heart team. Pre-proceduralscreening included standard transthoracic and/or transesophageal echocardiography,multislice computed tomography (MSCT), and if required, coronary angiography. Trans-thoracic echocardiography was performed at 24 to 48 h post-procedure and during clin-ical follow up at 1, 6 and 12 months, allowing to evaluate clinical improvement byreverse NYHA class and to assess prosthesis performance and left ventricular (LV) func-tion. The indication for TAVI was based on symptomatic severe AS [aortic valve area(AVA) b1 cm2 or mean gradient >40 mmHg] and high surgical risk profile defined as alogistic European System for Cardiac Operative Risk Evaluation (logistic-EuroSCORE)≥10% or Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) ≥10% orby associated co-morbidities not captured by the two scores (e.g. prior thoracic radiother-apy, porcelain aorta, liver cirrhosis, marked patient frailty) [13,14]. Some patients affectedby symptomatic isolated grade 4 AR entered in the registry. The suitability for thetransfemoral approach was determined by evaluating the ilio-femoral artery diameterson MSCT. †All patients provided written informed consent for the procedures and subse-quent data collection and analysis for research purposes. The devices currently availablewere the ballon-expandable Edwards Sapien (USA) and Sapien XT (Edwards LifesciencesInc, Irvine, CA, USA) and the self-expandable CoreValve Revalving System (Medtronic,Medtronic Inc, Minneapolis MN).

2.2. Quality of life

Post-TAVI QOL was assessed by a tailored questionnaire based on living conditions,physical status, walking capacity, perception of daily activity and psychic performancestatus (Table 1). Data were obtained from patients or family during the follow up visitor through further phone contact. Living conditions were classified as patient living “athome or in an institution” and general status as patient having or not “diffuse bodilypain”; physical performance status was defined by perception of daily activity(heavy, moderate or light) and by walking capacity, classified as patient “confined toa wheelchair”, or “able to walk unassisted≥500 mt/per day”, or “walking with trouble”(assisted, with sticks or walking frame). Psychic performance status was defined aspatient being “satisfied”, “not satisfied” or not being influenced by TAVI procedure.As a whole, QOL was classified as “good”, as “acceptable according to age” or “bad”.Being retrospective, the analysis of QOL was only descriptive; hence, no statisticaltest was performed.

3. Results

Clinical and echocardiographic characteristics of population enteredin the study are summarized in Table 2. A hundred forty-five prospec-tively studied octogenarians (mean age: 84.7±3.4 years; male: 70 pts,48.3%) undergone successful TAVI procedure for severe AS (141 pts;

Table 1Questionnaire concerning quality of life (QOL) following TAVI pro-cedure in the population study.

QOL

LifestyleAt homeIn a nursery

Physical statusDiffuse bodily painNo bodily pain

Perception of daily activityHeavyModerateLight

Walking capacityOn a weelchairWalking with troubleWalking unassisted≥500 m/per day

Psychic performance statusSatisfiedNot satisfiedNo change

QOL as a wholeGoodAcceptable according to ageBad

Please cite this article as: Grimaldi A, et al, Clinical outcome and qualitytation (TAVI) for symptomatic aortic stenosis, Int J Cardiol (2012), http

97.2%) (AVA: 0.77±0.21 cm2; mean gradient: 54.5±12.2 mmHg;peak gradient: 88±19.5 mmHg) or isolated grade 4 AR (4 pts; 2.8%).All patients were symptomatic (NYHA class: 2.8±0.6) and deemedunfit for conventional AVR according to advanced age and other risk fac-tors (Logistic EuroSCORE: 26.1±16.7; STS score: 9.2±7.74). Pre-TAVIechocardiography included assessments of LV systolic function (20.1%,30 pts with EF≤40%) and of systolic pulmonary arterial pressure(sPAP) (43.1±11.6 mmHg). All patients underwent successful TAVIprocedure using both systems devices, Edwards-SAPIEN valve (ESV)(63.5%) and Medtronic CoreValve (MCV) (35.9%) delivered by differentapproaches: transfemoral (83.4%), transaxillary (7.6%), transapical(8.3%) and transaortic (0.7%).

4. Outcomes

Clinical outcomes and echocardiographic endpoints are shown inTable 3. Rates of mortality at 30 days, 6 months and 1 year were re-spectively 2.8% (4/145 pts), 11.2% (13/116 pts) and 17.5% (14/80 pts)(Fig. 1). With a median follow-up of 13.5±10 months, survival ratewas 85.5% (124 pts) (Fig. 2); the median follow-up for patients able toattend the visit and answer QOL questionnaires was 16±10 months.

All patients referred improvement of clinical symptoms (NYHAbaseline 2.8±0.6 vs after 1.5±0.7; pb0.001) showing significant de-crease of sPAP (baseline 43.1±11.6 mmHg vs after 37.1±7.7 mmHg;pb0.001) and increase of LVEF in those with EF≤40% (baseline34.9±6.1% vs after 43.5±14.4%; p=0.006).

5. Quality of life

Results from QOL questionnaires are shown in Table 4. Among theoverall population, 99% of patients lived at home, 80.7 did not complainbodily pain, 65.3% described moderate daily fatigue, 47% walked withsticks and 49% walked unassisted. Concerning the psychic performance

NYHA class 2.8±0.58Logistic Euroscore 26.1±16.7STS score 9.2±7.74Indication for TAVI

AS 141 (97.2)AR 4 (2.8)

AVA (cm2) 0.77±0.21Aortic PG (mmHg)

Mean 54.5±12.2Max 88.14±19.55

EF (%) 52.4±11.5≤40 (30 pts) 34.9±6.1

sPAP (mmHg) 43.4±11.7Procedural approach

Transfemoral 121 (83.4)Transaxillary 11 (7.6)Transapical 12 (8.3)Transaortic 1 (0.7)

Device systemCorevalve (MCV) 52 (35.9)Edwards SAPIEN (ESV) 93 (63.5)

Valve size23 39 (26.9)26 74 (51)29 32 (22.1)

Values are expressed as mean±standard deviation.NYHA, New York Heart Association; STS, Society of Thoracic Surgeons; AS, aortic stenosis;AR, aortic regurgitation; AVA, aortic valve area; EF, ejection fraction; sPAP, systolic pulmo-nary arterial pressure. MCV, Medtronic CoreValve; ESV, Edwards-SAPIEN valve.

of life in octogenarians following transcatheter aortic valve implan-://dx.doi.org/10.1016/j.ijcard.2012.09.079

Table 3Clinical outcome and echocardiographic endpoints in the overall population.

Variable Mean±SD N (%)

Population Study 145Total deaths at follow-up 21/145 (14.5)Mortality rates at follow-up

30 days 4/145 (2.8)6 months 13/116 (11.2)1 year 14/80 (17.5)

Leading causes of death 21Sudden death 3Arrhythmic storm 1CHF following iatrogenic VSD 1Aortic rupture (in-hospital) 2Cancer 3Non cardiogenic respiratory failure 2Intracranial bleeding 2Ischemic stroke 1Other 3Unknown 3

NYHA class Pre-TAVI Post-TAVI P value2.8±0.6 1.5±0.7 b0.001⁎

Echocardiographic Endpoints Pre-TAVI Post-TAVI P valueEF (%)

>40 53.3±10.6 53±10.6 n.s.≤40 34.9±6.1 43.5±14.4 0.006⁎

sPAP (mmHg) 43.1±11.6 37.1±7.7 b0.001⁎

Values are expressed as mean±standard deviation.CHF, congestive heart failure; VSD, ventricular septal defect; NYHA, New York HeartAssociation; EF, ejection fraction; sPAP, systolic pulmonary arterial pressure.⁎ pb0.01.

Fig. 2. Survival rate in the overall population following TAVI procedure.

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status following TAVI, 79% of patients (39.5% among pts ≥85 years) re-ferred self-awareness improvement (Fig. 3); as a whole, QOL was re-ferred to be “good” by 72 pts (58% among overall population; 31.4%among pts ≥85 years), “acceptable according to age” by 42 pts (34%among overall population; 16% among pts ≥85 years) and “bad” by10 pts (8% of overall population; 3.2% among pts ≥85 years) (Fig. 4).

Fig. 1. Mortality rates in the overall pop

Please cite this article as: Grimaldi A, et al, Clinical outcome and qualitytation (TAVI) for symptomatic aortic stenosis, Int J Cardiol (2012), http

No significant correlation was found between the procedural complica-tions of TAVI (VARC criteria) and the clinical parameters describing theQOL outcomes in the population study (Table 5).

6. Discussion

Since there is no effective conservative treatment for symptomaticsevere AS, TAVI has become an appropriate alternative for elderly

ulation following TAVI procedure.

of life in octogenarians following transcatheter aortic valve implan-://dx.doi.org/10.1016/j.ijcard.2012.09.079

Table 4Quality of life following TAVI procedure in the population study.

VARIABLE N (%)

LifestyleAt home (99)In a nursery (1)

Physical statusDiffuse bodily pain 24 (19.3)No bodily pain 100 (80.7)

Walking capacityOn a wheelchair 5 (4)Walking with trouble 58 (46.8)Walking unassisted≥500 m/per day 61 (49.2)

Perception of daily activityHeavy 22 (17.7)Moderate 81 (65.3)Light 21 (17)

Overall population Age ≥85 years

Psychic performance status 124 (100) 63 (50.8)Satisfied 98 (79) 49 (39.5)Not satisfied 8 (6.5) 2 (1.6)Unchanged 18 (14.5) 12 (9.7)

QOL as a wholeGood 72 (58) 39 (31.5)Acceptable according to age 42 (34) 20 (16.1)Bad 10 (8) 4 (3.2)

4 A. Grimaldi et al. / International Journal of Cardiology xxx (2012) xxx–xxx

patients with very high surgical risk [14]. At the time patients are re-ferred for intervention, they present reduced life expectancy and severeheart failure symptomswith consequent restrictions in the normal dailyliving. In our report TAVI shows a favourable clinical outcome atmid-term follow-up in very elderly patients, reporting a rate of deathfrom any cause of 2.8% at 30-days, 11.2% at 6 months and 17.5 at1-year follow up (Fig. 1). These results reflect proper patients selectionand improved procedural learning curve including transfemoral andother approaches in agreement with previous reports [15].

6.1. QOL assessment

Previous studies have showed clinical benefit in terms of qualityof life in the first months [10] after TAVI but midterm follow-upQOL results are scarce [16].

Fig. 3. Quality of life in the overall popu

Please cite this article as: Grimaldi A, et al, Clinical outcome and qualitytation (TAVI) for symptomatic aortic stenosis, Int J Cardiol (2012), http

Clinical findings and referred improvements of QOL qualitativelyreflect the good results of TAVI in the elderly. Currenty, advancedage is other than an obsolete concern in terms of health-related qual-ity of life [17–21]. Mean age is rising in western countries and theperception of disease and discomforts may be totally different in theelderly compared to the youngs. Young patients do not easily acceptbody discomforts and nothwithstanding a prompt physical recoveryfollowing invasive treaments, they might pass through a depressivestatus and be concerned about disease recurrence during a long ex-pectancy of life; old patients do not reveal the same fast-track recov-ery andmay experience more periprocedural complications related tothe different biological status. But interestingly, the trend of psychicrecovery may be peculiar: octagenarians may experience a newtrend of life, if body discomfort diseappear. As a consequence, elderlypatients might consider their overall QOL as good (58% of overall popu-lation; 31.4% among pts≥85 years (Fig. 4), whereas the family will de-fine it as just acceptable, being the perception totally different accordingto the expectancy of life. On the other hand, elderly patients may be to-tally refractary (8% of overall population; 3.2% among pts ≥85 years(Fig. 3) to psychic improvement depending on chronicmorbidity affect-ing the mood and/or self-awareness (e.g. cancer, long-term oxygentherapy, cognitive impairment or recent widowood). Walking capacitymight not necessarily be a major issue affecting QOL as a whole sincealso patients confined “on a weelchair” (5 pts, 34.5%) considered theircurrent QOL as “acceptable according to age” (4 pts, 80%) once TAVIprocedure has removed dyspnea and severe fatigue allowing them toperform the daily activities on the same weelchair. This conditionwould probablymean that for elderly patients the perception of diseaseand recovery should be addressed toward different targets such as im-proved self–awareness and routine daily activity [18]. The feeling thatpatient's quality of life should be measured in clinical practice has ledto the development of a wide range of questionnaires [17,22] butmost of them might be difficult to assess in the clinical setting of veryelderly patients with symptomatic aortic stenosis and high riskcomorbidities. In our population advanced age (50% of pts were≥85 years) plus critical status (80.3% of pts ≥85 years were inNYHA III–IV) made the pre-procedural QOL assessment very difficultto get at admission to hospital. At follow-up, the analysis was retro-spective and descriptive and no comparison was performed to test astatistical QOL improvement between pre- and post-TAVI assessmentsas reported by other studies [10,11,21]. Nevertheless, we can assume

lation and in pts ≥85 years of age.

of life in octogenarians following transcatheter aortic valve implan-://dx.doi.org/10.1016/j.ijcard.2012.09.079

Fig. 4. Psychic performance status following TAVI procedure and in pts ≥85 years of age.

Table 5Correlation between procedural complications of TAVI (VARC definition) and quality of life in the population study.

Procedural complications Events Walking capacity n (%) Perception of activity n (%) Mental performance n (%) QOL n (%)

0=no 1 2 3 1 2 3 1 2 3 1 2 31=yes

Cardiovascular events 0=122 5(4) 57(47) 60(49) 22(18) 79(65) 21(17) 97(79) 8(7) 17(14) 70(57) 42(34) 10(8)1=2 0 1(50) 1(50) 0 2(100) 0 1(50) 0 1(50) 2(100) 0 0p=NS

Bleeding Life-threatening or major 0=46 1(2) 23(50) 22(48) 9(20) 31(64) 6(13) 38(83) 0 8(19) 28(61) 15(33) 3(6)1=78 4(5) 35(45) 39(50) 13(17) 50(64) 15(19) 60(77) 8(10) 10(3) 44(56) 27(35) 7(9)p=NS

AKI/stage 3 0=117 5(4) 54(46) 58(50) 21(18) 75(64) 21(18) 92(78) 8(7) 17(14) 66(56) 41(35) 10(9)1=7 0 4(57) 3(43) 1(14) 6(86) 0 6(86) 0 1(14) 6(86) 1(14) 0p=NS

MVC 0=104 5(5) 49(47) 50(48) 20(19) 67(64) 17(63) 81(78) 6(6) 17(16) 60(58) 36(35) 8(8)1=20 0 9(45) 11(55) 2(10) 14(70) 4(20) 17(85) 2(10) 1(5) 12(60) 6(30) 2(10)p=NS

CSE 0=46 2(4) 24(52) 20(44) 5(11) 35(76) 6(13) 41(89) 3(7) 2(4)* 27(59) 15(33) 4(9)1=77 3(4) 33(43) 41(53) 17(22) 45(58) 15(20) 56(72) 5(7) 16(21)* 45(59) 26(34) 6(8)*p=0.04

PM implantation 0=109 4(4) 51(47) 54(50) 19(17) 71(65) 19(17) 87(80) 5(5) 17(16) 65(60) 35(32) 9(8)1=15 1(7) 7(47) 7(47) 3(20) 10(67) 2(13) 11(73) 3(20) 1(7) 7(47) 7(47) 1(7)p=NS

QOL: Quality of life; AKI: Acute Kidney Injury; MVC: Major vascular complications; CSE: Combined Safety Endpoint (30 dd) according to VARC definitions.1,2,3=grading of QOL's parameters (see Table 4).

5A. Grimaldi et al. / International Journal of Cardiology xxx (2012) xxx–xxx

that physical and psychic performance status were both relevantmarkers of improved QOL in the population study since no signifi-cant association was found between the complications of TAVI proce-dure according to the VARC definition [23] and the clinical parametersaffecting the QOL outcomes (Table 5).

7. Conclusions and limits

TAVI procedures provides significant improvements in terms of clini-cal outcome and subjectivehealth-related quality of life also in very elder-ly patients with symptomatic AS. Impressive improvement in physicaland psychological dimensions was noted at 16-month follow-up andmost of patients were living independently and referred self-awarenessimprovement, reaffirming their decision to have TAVI. As a limit of thestudy, according to the advanced age and population's morbidity, thepost-TAVI analysis was only descriptive and further prospective studieswill be necessary to test the real clinical predictors of QOL improvement

Please cite this article as: Grimaldi A, et al, Clinical outcome and qualitytation (TAVI) for symptomatic aortic stenosis, Int J Cardiol (2012), http

in such a high risk population, possibly based on simple butmore clinical-ly focused questionnaires.

Acknowledgement

The authors of this manuscript have certified that they complywith the Principles of Ethical Publishing in the International Journalof Cardiology [24].

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of life in octogenarians following transcatheter aortic valve implan-://dx.doi.org/10.1016/j.ijcard.2012.09.079