Quality of life among patients undergoing transcatheter aortic valve implantation

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Outcomes, Health Policy, and Managed Care Quality of life among patients undergoing transcatheter aortic valve implantation Markus Krane, MD, a Marcus-Andre ´ Deutsch, MD, a Sabine Bleiziffer, MD, Lisa Schneider, MS, Hendrik Ruge, MD, Domenico Mazzitelli, MD, Christian Schreiber, MD, PhD, Gernod Brockmann, MD, Bernhard Voss, MD, Robert Bauernschmitt, MD, PhD, and Ru ¨diger Lange, MD, PhD Munich, Germany Background Transcatheter aortic valve implantation (TAVI) has been introduced to offer a new treatment option for patients who are not eligible for conventional aortic valve replacement. Especially in this subset of patients, the expected improvement of quality of life (QoL) after valve implantation will be critical for decision-making for TAVI. Methods We performed a prospective analysis of 99 patients (41 male) aged 82 years (range 57-94 years) who underwent TAVI. For assessment of QoL, the Short Form 36 Health Survey Questionnaire was used preoperatively and 3 months after TAVI. Results Thirty-day mortality rate was 10.1%. The Short Form 36 Health Survey Questionnaire scores for physical functioning (34.7 ± 2.8 vs 48.5 ± 3.4, P b .001), bodily pain (61.7 ± 3.1 vs 73.2 ± 2.9, P b .01), general health (47.1 ± 1.9 vs 54.1 ± 2.3, P b .01), and vitality (37 ± 2.8 vs 46.1 ± 2.7, P b .01) increased significantly 3 months after TAVI compared with preoperative scores. No significant changes were found for role-physical (21.7 ± 4.1 vs 31.1 ± 5.1, P b .08), social functioning (74.6 ± 3.4 vs 74.6 ± 3.1, P = 1), and mental health (63 ± 2.9 vs 67.4 ± 2.2, P = .17) 3 months after TAVI. Only the score for role-emotional (69.3 ± 5.6 vs 51.7 ± 6, P = .02) decreased significantly 3 months after TAVI compared with the preoperative score. Corresponding to these results, the physical health summarized score (31.2 ± 1.2 vs 38.6 ± 1.6, P b .001) was significantly increased 3 months after TAVI compared with the preoperative score, whereas the mental health summarized score (48.5 ± 1.8 vs 47.3 ± 1.7, P = .5) showed no changes. Conclusion In patients who are not eligible for conventional aortic valve replacement, TAVI leads to a considerable QoL improvement within 3 months after valve implantation. (Am Heart J 2010;160:451-7.) Aortic stenosis (AS) is currently the most frequent acquired valvular heart disease in Western industrialized countries, and its prevalence considerably increases with age. 1 Both a rapidly growing proportion of the older population and the ability to perform complex cardiac surgical procedures in these patients have led to a growing number of elderly patients referred for aortic valve surgery. Surgical aortic valve replacement (AVR) is the criterion standard for the treatment of high-grade, symptomatic AS. Advances in operative, cardiopulmo- nary bypass, and myocardial protection techniques as well as improved perioperative care have made it possible to perform open-heart surgery in octogenarians with acceptable morbidity and mortality rates. 2-4 How- ever, open-heart surgery in the elderly is still associated with higher morbidity and mortality rates compared with younger patients. 5 In an effort to minimize perioperative morbidity and mortality associated with sternotomy or cardiopulmonary bypass, less-invasive, catheter-assisted techniques for aortic valve implantation (transcatheter aortic valve implantation [TAVI]) have been developed to offer an alternative treatment modality for those patients either not amenable or considered to be too high an operative risk for conventional AVR. During the last years, it has been demonstrated that TAVI is safe and can be performed with remarkable short- and midterm results. 6,7 An improvement in quality of life (QoL) after TAVI, especially in elderly patients with severe comorbidities, plays a critical role not only in the decision-making for TAVI but also in judging the outcome of this novel and promising technology. 8 In this respect, less is known about the question of whether the novel treatment option leads to a QoL improvement in these patients. Therefore, the objective of our study was to evaluate changes in the QoL of patients undergoing TAVI. From the Department of Cardiovascular Surgery, German Heart Center Munich, Technische Universität München, Munich, Germany. a M. K. and M. A. D. contributed equally to this work. Submitted December 28, 2009; accepted May 8, 2010. Reprint requests: Markus Krane, MD, German Heart Center Munich, Department of Cardiovascular Surgery, Technische Universität München, Lazarettstrasse 36, 80636 Munich, Germany. E-mails: [email protected], [email protected] 0002-8703/$ - see front matter © 2010, Mosby, Inc. All rights reserved. doi:10.1016/j.ahj.2010.05.038

Transcript of Quality of life among patients undergoing transcatheter aortic valve implantation

Outcomes, Health Policy, and Managed Care

Quality of life among patients undergoingtranscatheter aortic valve implantationMarkus Krane, MD,a Marcus-Andre Deutsch, MD,a Sabine Bleiziffer, MD, Lisa Schneider, MS, Hendrik Ruge, MD,Domenico Mazzitelli, MD, Christian Schreiber, MD, PhD, Gernod Brockmann, MD, Bernhard Voss, MD,Robert Bauernschmitt, MD, PhD, and Rudiger Lange, MD, PhD Munich, Germany

Background Transcatheter aortic valve implantation (TAVI) has been introduced to offer a new treatment option forpatients who are not eligible for conventional aortic valve replacement. Especially in this subset of patients, the expectedimprovement of quality of life (QoL) after valve implantation will be critical for decision-making for TAVI.

Methods We performed a prospective analysis of 99 patients (41 male) aged 82 years (range 57-94 years) whounderwent TAVI. For assessment of QoL, the Short Form 36 Health Survey Questionnaire was used preoperatively and3 months after TAVI.

Results Thirty-day mortality rate was 10.1%. The Short Form 36 Health Survey Questionnaire scores for physicalfunctioning (34.7 ± 2.8 vs 48.5 ± 3.4, P b .001), bodily pain (61.7 ± 3.1 vs 73.2 ± 2.9, P b .01), general health (47.1 ± 1.9vs 54.1 ± 2.3, P b .01), and vitality (37 ± 2.8 vs 46.1 ± 2.7, P b .01) increased significantly 3 months after TAVI comparedwith preoperative scores. No significant changes were found for role-physical (21.7 ± 4.1 vs 31.1 ± 5.1, P b .08), socialfunctioning (74.6 ± 3.4 vs 74.6 ± 3.1, P = 1), and mental health (63 ± 2.9 vs 67.4 ± 2.2, P = .17) 3 months after TAVI. Onlythe score for role-emotional (69.3 ± 5.6 vs 51.7 ± 6, P = .02) decreased significantly 3 months after TAVI compared with thepreoperative score. Corresponding to these results, the physical health summarized score (31.2 ± 1.2 vs 38.6 ± 1.6, P b .001)was significantly increased 3 months after TAVI compared with the preoperative score, whereas the mental health summarizedscore (48.5 ± 1.8 vs 47.3 ± 1.7, P = .5) showed no changes.

Conclusion In patients who are not eligible for conventional aortic valve replacement, TAVI leads to a considerable QoLimprovement within 3 months after valve implantation. (Am Heart J 2010;160:451-7.)

Aortic stenosis (AS) is currently the most frequentacquired valvular heart disease in Western industrializedcountries, and its prevalence considerably increases withage.1 Both a rapidly growing proportion of the olderpopulation and the ability to perform complex cardiacsurgical procedures in these patients have led to agrowing number of elderly patients referred for aorticvalve surgery. Surgical aortic valve replacement (AVR) isthe criterion standard for the treatment of high-grade,symptomatic AS. Advances in operative, cardiopulmo-nary bypass, and myocardial protection techniques aswell as improved perioperative care have made it

From the Department of Cardiovascular Surgery, German Heart Center MunichTechnische Universität München, Munich, Germany.aM. K. and M. A. D. contributed equally to this work.Submitted December 28, 2009; accepted May 8, 2010.Reprint requests: Markus Krane, MD, German Heart Center Munich, Department oCardiovascular Surgery, Technische Universität München, Lazarettstrasse 36, 80636Munich, Germany.E-mails: [email protected], [email protected]/$ - see front matter© 2010, Mosby, Inc. All rights reserved.doi:10.1016/j.ahj.2010.05.038

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possible to perform open-heart surgery in octogenarianswith acceptable morbidity and mortality rates.2-4 How-ever, open-heart surgery in the elderly is still associatedwith higher morbidity and mortality rates compared withyounger patients.5 In an effort to minimize perioperativemorbidity and mortality associated with sternotomy orcardiopulmonary bypass, less-invasive, catheter-assistedtechniques for aortic valve implantation (transcatheteraortic valve implantation [TAVI]) have been developed tooffer an alternative treatment modality for those patientseither not amenable or considered to be too high anoperative risk for conventional AVR. During the last years,it has been demonstrated that TAVI is safe and can beperformed with remarkable short- and midterm results.6,7

An improvement in quality of life (QoL) after TAVI,especially in elderly patients with severe comorbidities,plays a critical role not only in the decision-making forTAVI but also in judging the outcome of this novel andpromising technology.8 In this respect, less is knownabout the question of whether the novel treatmentoption leads to a QoL improvement in these patients.Therefore, the objective of our study was to evaluatechanges in the QoL of patients undergoing TAVI.

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MethodsPatientsOnly patients ≥75 years old or patients ineligible for

conventional AVR because of considerable comorbidities wereselected for TAVI as described before.7

Preoperative assessment included medical history, physicalexamination, transthoracic echocardiography, transesophagealechocardiography, and computed tomography of the thorax,abdomen, and pelvis with 3-dimensional reconstruction of thecomplete aorta and specific reconstruction (individual orthog-onal angulation) of the aortic root and coronary angiography.For our prospective cohort study, we included patients

undergoing a TAVI procedure at the German Heart CenterMunich from November 2007 to December 2008. Inclusioncriterion for participation was the ability to understand, read,and write German. Furthermore, the included patients had tohave the ability to answer the questionnaire by themselves orwith minor help by one of their family members.Quality of life was assessed by the Short Form 36 Health

Survey Questionnaire (SF-36). All included patients completedbaseline questionnaires after admission into our hospital at least1 day before the intervention. At follow-up after 3 months,patients received the SF-36 again by mail and an additionalquestionnaire to evaluate their individual living condition andthe current New York Heart Association (NYHA) functionalclass and to reaffirm the decision to have TAVI.The study was approved by the local ethics committee (2234/

08). All patients signed an informed consent.

The SF-36The SF-36 was used to evaluate the status of QoL. The SF-36

consists of 36 items grouped in 8 general health parameters:physical functioning, role-physical, bodily pain, general health,role-emotional, social functioning, vitality, and mental health.The number of possible responses per item varies from 2 to 6.For each parameter, scores are calculated and transformed to ascale from 0 to 100, with higher scores reflecting a better QoL.Scores were calculated by using the standard SF-36 SPSS syntaxprovided with the SF-36 test manual.Each item measures performance in different aspects of

daily life3:

Physical functioning:

limitations in lifting, climbing, bending, kneeling,walking, or running

Role-physical:

degree of physical health to perform activitiestypical for the specific age and socialresponsibility, such as a job, community activities,and volunteer work

Bodily pain:

intensity and duration of bodily pain andlimitations in activities due to pain

General health:

beliefs and evaluations of overall health Vitality: feelings of energy, pep, fatigue, and tiredness Social functioning: ability to develop, maintain, and nurture mature

social relationships (including family, friends,and spouse)

Role-emotional:

personal feelings about job performance, work, orother activities

Mental health:

emotional, cognitive, and intellectual status

The 8 parameters could be summarized into 2 summarizedscores: the physical health score and the mental health score. It

is a self-administered instrument that takes about 15 minutes tocomplete. The used questionnaire evaluates the status of QoLfor the previous 4 weeks.

Assessment of the current living condition andreaffirming decision to have TAVIBeyond the SF-36, patients were asked about the degree of

independency at home and whether they would again decide infavor of TAVI. To describe their current independence, theywere able to decide between 5 categories:

1. Living completely independent alone or with her/hishusband/wife

2. Living independent alone or with her/his husband/wifeand receiving minor help for cleaning, shopping, etc

3. Living alone or with her/his husband/wife and receivingmajor help for dressing, assistance for personal hygiene

4. Living in an assisted living facility5. Living in a nursing home facility

We added a further question for the confirmation or negationof the decision to undergo TAVI in the retrospective 3 monthsafter the procedure. This question could be answered with yesor no.

Valve device and route of implantationThe CoreValve prosthesis (Medtronic, Irvine, CA) and the

Sapien prosthesis (Edwards Lifesciences, Irvine, CA) wereimplanted in our study population. The CoreValve prosthesiswas used for transarterial implantation and the Sapienprosthesis for transapical implantation. The CoreValve prosthe-sis, a porcine pericardial valve mounted in a self-expandablenitinol stent, has an 18F delivery sheath suitable for vessels≥6.5 mm. The CoreValve is typically implanted retrogradelyfrom the femoral artery under fluoroscopic guidance. Inpatients with contraindications for transfemoral valve implan-tation, that is, peripheral vessel disease, previous peripheralbypass surgery, or stenosis of the femoral or iliac vessels, wehave chosen the subclavian artery as access site.9 Transfemoralvalve implantation via a modified Seldinger technique wasperformed in combination with a device closure system(ProStar XL; Abbott Vascular, Abbott Park, IL) or with surgicaldissection of the femoral artery. For the subclavian access, thesubclavian artery was dissected through a 5-cm subclavicularskin incision.The Sapien prosthesis is a bovine pericardial valve in a

balloon-expandable steel stent. Transapical valve implantationwith the Sapien prosthesis was performed through a leftanterolateral minithoracotomy in patients who did not meetthe vessel diameter requirements or had other contraindicationsfor transarterial implantation (ie, severe calcifications of theaortic arch).To achieve stable hemodynamics and avoid patient move-

ments during valve implantation, the procedure was performedunder general anesthesia. All patients were operated on in asurgical hybrid suite. A transient pacemaker wire was placedtransvenously for transarterial retrograde implantation tech-nique, whereas a transient epicardial pacemaker was used fortransapical antegrade valve implantation. Balloon valvuloplastyof the native, stenotic aortic valve was performed under rapidventricular pacing at 160 to 180 beat/min in all patients. The

Table I. Preoperative patient population characteristics

Parameter n (%)

Male 41 (41.4)Age, yMean ± SD 81 ± 6Median (range) 82 (57-94

LVEF (%)N50% 63 (6335%-50% 20 (20b35% 16 (16

CAD 58 (58.8%PAD 24 (24.5%MI 8 (8.1%)TI 11 (11.1%MI + TI 4 (4%)Pulmonary hypertension (N60 mm Hg systemic) 20 (20.2%Previous cardiac surgery 21 (21.2%Pacemaker 13 (13.1%CVA 11 (11.1%COPD 17 (17.2%Renal insufficiency (creatinine N1.5 mg/dL) 18 (18.4%Log EuroScore 20%

LVEF, Left ventricular ejection fraction; CAD, coronary artery disease; PAD, peripheraartery disease; MI, mitral insufficiency; TI, tricuspid insufficiency; CVA, cerebrovascular accident; COPD, chronicle obstructive pulmonary disease.

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prosthesis was placed in the aortic annulus under fluoroscopycontrol. Prosthesis function was assessed by angiography andintraoperative transesophageal echocardiography.

Statistical analysisResults are presented as median or mean ± 1 SD. Results of the

SF-36 are depicted as mean ± SE. For comparisons betweendichotomous variables, Fisher exact test was used; and forcomparison of means of continuous variables, the t test wasused. A P value of b .05 was considered to be statisticallysignificant. All statistical analyses were performed using the SPSS16 software (SPSS, Chicago, IL).

No extramural funding was used to support this work. Theauthors are solely responsible for the design and conduct of thisstudy, all study analyses, the drafting and editing of the paper,and its final contents.

ResultsIn our prospective study, 99 patients (41 male,

median age 82 years) were included who underwentTAVI between November 2007 and December 2008and participated in the preoperative evaluation of theirQoL status by the SF-36. Seventy-three patients weretreated with a transarterial CoreValve prosthesis,whereas 26 underwent TAVI with a transapical Sapienaortic valve prosthesis. Detailed preoperative charac-teristics of the entire study cohort are summarized inTable I. Figure 1 shows the postoperative follow-up ofthe entire cohort. Sixty-eight of 99 patients whounderwent TAVI completed the SF-36 at baseline and3 months after TAVI.

Clinical outcomeIn our study population, the 30-day mortality was

10.1%. Four patients suffered from a stroke aftertransfemoral CoreValve Implantation. Two of them diedon postoperative day 7 and 32, respectively. Theremaining 2 patients were not able to participate in the3-month follow-up. The mean postprocedural stay was9 ± 6.1 days. Detailed clinical outcome is depicted inTable II.Having achieved a significant increase of the effective

orifice area (P b .001), the peak and mean pressuregradients of the aortic valve decreased significantly (bothP b .001). Baseline and postprocedural echocardiograph-ic parameters are given in Table III. The mean NYHA classimproved significantly from 3.1 ± 0.25 to 1.7 ± 0.62 (P b.001) 3 months after TAVI (Figure 2).

QoL as assessed by the SF-36The scores for physical functioning (34.7 ± 2.8 vs 48.5 ±

3.4, P b .001), bodily pain (61.7 ± 3.1 vs 73.2 ± 2.9, P b.01), general health (47.1 ± 1.9 vs 54.1 ± 2.3, P b .01), andvitality (37 ± 2.8 vs 46.1 ± 2.7, P b .01) were significantlyimproved 3 months after TAVI. No significant changeswere found for role-physical (21.7 ± 4.1 vs 31.1 ± 5.1, P b.08), social functioning (74.6 ± 3.4 vs 74.6 ± 3.1, P = 1),and mental health (63 ± 2.9 vs 67.4 ± 2.2, P = .17) 3months after TAVI. The SF-36 score for role-emotional(69.3 ± 5.6 vs 51.7 ± 6, P = .02) was significantlydecreased 3 months after TAVI compared with thepreoperative score (Figure 3, A and B). Three monthsafter TAVI, the physical health summarized score (31.2 ±1.2 vs 38.6 ± 1.6, P b .001) was significantly improvedcompared with the preoperative score. In contrast, themental health summarized score (48.5 ± 1.8 vs 47.3 ± 1.7,P = .5) showed no changes between the preoperativescore and the score 3 months after TAVI.

Reaffirming decision to have TAVI and currentliving conditionsThe majority of patients (85%) who underwent TAVI

reaffirmed their decision to have TAVI 3 months afterthe procedure. Furthermore, N80% of patients whoparticipated in the 3-month follow-up lived independent-ly or with minor help at home, whereas only 3 patientsrequired an assisted living or nursing home facility(Figure 4).

DiscussionIn this prospective single-center study, by using the

well-validated and often applied SF-36, we could demon-strate that TAVI is able to improve the QoL 3 months afterintervention compared with preoperative scores.Corresponding to an improved QoL, an improvement inNYHA functional class was achieved. The majority of

Figure 1

The flowchart shows the follow-up of the included 99 patients.

Table II. Clinical outcome within 30 days

Parameter n (%)

30-d mortality 10 (10.1%)Stroke 4 (4.0%)Vascular complications 12 (12.1%)Nonfatal pericardial tamponade 1 (1.0%)Postoperative renal insufficiency 15 (15.1%)Atrioventricular block grade III 20 (20%)Myocardial infarction 3 (3%)Postprocedural stay (d)Mean ± SD 9 ± 6.1Median (range) 7 (3-41)

Table III. Baseline and postprocedural echocardiographiccharacteristics at discharge

Preoperative Postoperative P value

EOA (cm2) 0.65 ± 0.17 1.54 ± 0.4 b.001Peak pressure gradient

(mm Hg)78.6 ± 22.3 21.8 ± 6.8 b.001

Mean pressure gradient(mm Hg)

48.7 ± 15.0 12.54 ± 4.1 b.001

Aortic regurgitation (%)None, minimal, or mild 67 (67.7%)Mild to moderate 18 (18.2%)Moderate to severe 4 (5.1)

Periprosthetic leaks (%) 60 (60.2%)

EOA, Effective orifice area.

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patients who underwent TAVI confirmed their decisionto have TAVI. Remarkably, 85% of the participating 68patients who answered the questionnaire at 3-monthfollow-up lived independently or with minor help at home.Transcatheter aortic valve implantation, a novel treat-

ment modality in the armamentarium to treat severesymptomatic AS, is currently performed to treat patientsineligible for conventional AVR. The assessment of thisnovel technique has been claimed to be critical for apatient-centered decision-making and future health carepolicies.10-12 First experiences are promising with regardto mortality rates and functional data. According to the

recent literature, the 30-day mortality of TAVI is 9% to18% and is currently 10.1% at our own institution. Currentavailable results obtained with TAVI suggest that thesetechniques are feasible and can provide hemodynamicand clinical improvement.6,7

In a position statement from the European Associationof Cardio-Thoracic Surgery and the European Society ofCardiology, a paramount importance was ascribed to theQoL outcome in this particular patient population. Beyondmortality, morbidity, and hemodynamic valve performance,

Figure 3

A, Results of the SF-36 preprocedure (black bars) compared with 3months after TAVI (gray bars) of the physical health parameters. B,Results of the SF-36 preprocedure (black bars) compared with 3months after TAVI (gray bars) of the mental health parameters. C,Results of the summarized scores for the physical health and themental health preprocedure (black bars) and 3 months after TAVI(gray bars). ⁎P b .05, ⁎⁎P b .01, and ⁎⁎⁎P b .001.

Figure 2

The NYHA class changes comparing pre- and postoperative status atfollow-up of the included 68 patients (preoperative NYHA class =black bars; postoperative NYHA class = gray bars).

Krane et al 455American Heart JournalVolume 160, Number 3

QoL dynamics have to be assessed to guide a patient-centered clinical decision-making.10-12 In the aged and frailpopulation currently presenting for TAVI, clinicians areconfronted with a heterogeneous group of individuals interms of life expectancy, presence of comorbidities, anddegree of disability. In addition, our study populationshowed a high frequency of comorbidities in patientsselected for TAVI (Table I). The presence of multiplecomorbidities may limit functional and QoL improvementsdespite a hemodynamically effective treatment of the AS.In this respect, little is known about the question ofwhether this novel treatment modality translates into aconsiderable improvement of the QoL in this particularpatient population.At present, our study is the largest and most compre-

hensive prospective study investigating the QoL dynam-ics in patients undergoing TAVI. Recently, the results ofthe first prospective study using an SF-12 were publishedby Ussia et al.13 They demonstrated in an analysis of57 consecutive patients, of whom 30 patients completeda 5-month follow-up period, a clearly significant increasein all 8 QoL parameters assessed by the SF-12.Corresponding to these results, both summarized scoresimproved significantly 5 months after TAVI in their studypopulation. Furthermore, none of their patients experi-enced a worsening in their QoL scores after theprocedure. This finding is surprising and different fromour observation. We were able to show a remarkableincrease for parameters describing the physical healthand, corresponding to this, a significantly increasedphysical health summarized score. Contrary to the resultsdescribed by Ussia et al, we were not able to show animprovement for mental health parameters except for thevitality score. Accordingly, the mental health summarizedscore showed no changes 3 months after the procedure

in our study population. We believe that we could notestimate an improvement in terms of mental health in theshort term especially in this aged population withconsiderable comorbidities. It is possible that thefollow-up period of 3 months was too short to translateinto an improvement of the mental health scores. Qualityof life before the procedure may be impaired by physical

Figure 4

Degree of independence and form of living of the 68 patients whocompleted follow-up 3 months after TAVI.

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symptoms, psychological problems, adverse treatmenteffects, and social limitations. These factors may leadindividuals to withdraw from activities and previoussocial contacts, losing their social relations and socialsupport over a longer period preoperatively when thesymptoms of AS and heart failure are becoming increas-ingly apparent.14 Quite likely, postprocedurally, it mighttake longer than 3 months to reverse the decay ofsocial activities and relationships represented in the SF-36domains of social functioning, role-emotional, andmental health.In addition to the standardized SF-36, we asked our

patients whether they would again decide to undergo theprocedure. The majority of our patients (85%) whocompleted the follow-up reaffirmed their decision ofhaving undergone TAVI. One possibility for this positivefeedback is the remarkable improvement in QoL afterTAVI. Moreover, we evaluated the current form of livingrepresenting an important fact with respect to thepatient's degree of independence. Remarkably, wecould demonstrate that the majority of patients whocompleted the follow-up are able to live independently asearly as 3 months after the procedure. This item is notrepresented in either the SF-12 or the SF-36. Unlike inyoung patients, the main purpose of treatment in theelderly is to improve symptoms and to preserve the levelof independence rather than to increase the duration oflife.15 A study conducted by Stanek et al16 revealed thatthe majority of congestive heart failure patient placedgreater importance on improved symptoms rather thanlonger survival as preferred therapeutic goal.

LimitationsThe results of the present study were acquired at

a single institution, which potentially limits theirgeneralizability.

Because of the short follow-up period, we cannotexclude that longer follow-up will result in worse QoLoutcomes. On the other hand, it might be possible thatlonger follow-up might be able to show better QoL resultsespecially when looking at mental health scores. Further-more, because of the current patient number, we werenot able to identify predictors for a patient selectionregarding the worsening or improvement in QoL.During the study period, 164 patients underwent TAVI

in our hospital. However, a comparison of included (n =99) and nonincluded (n = 65) patients revealed nosignificant differences regarding gender, coronary arterydisease, chronicle obstructive pulmonary disease, cere-brovascular accident, left ventricular ejection fraction,pulmonary hypertension, renal insufficiency, and previ-ous cardiac surgery. The Society of Thoracic Surgeonsscore showed no differences between both groups,whereas the log Euroscore showed a trend to besignificantly higher in the group of nonparticipantscompared with the group of participants (24.8% vs20%, P = .05).The QoL data could have a potential selection bias due

to the 20 patients who died early after TAVI or within thefollow-up period or/and due to the 11 patients who failedto complete the questionnaire 3 months after TAVI.

ConclusionIn conclusion, especially in the elderly patient,

postprocedural QoL is and will be decisive for decision-making. In judging outcomes, not only mortality,morbidity, hemodynamic performance, and durability ofthe novel valves have to be considered, but alsosymptoms and QoL. Our results show that, in the majorityof patients suffering from severe symptomatic AS, TAVI isable to improve QoL and to preserve a high degree ofindependence. The question of whether this effect willlast and whether TAVI might be able to improve mentalhealth in the longer term remains to be determined.

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