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10 The Impact ofValve Surgery ontheHealth-Related Quality ofLife ofElderly Patients: Systematic Review
Operative Demographic
SAVR, TAVI, MVR, MVr
improve QoL
Full sternotomy vs Limited
sternotomy/Mini
Repair vs replacement
Post Valve surgery QoL
Fig. 10.2 Factors affecting HRQOL post valve surgery
Renal failure
Stroke/AF
NYHA/LV dysfunction
Diabetes/MI
205
reported that concomitant CABG and AVR is associated with poor QoL, precipitating higher mortality rates compared to sole AVR, however, on regression analysis—CABG alone was not signicantly responsible for this increase [26]. This was further challenged by Markou and col­leagues who reported in their prospective study of 215 concomitant (CABG+AVR) and 200 iso­lated valve that patients undergoing combined surgery exhibited greater benet from their sur­gery than their counterpart.
Ejection Fraction, NYHA andLV function
Three studies pre-selected ejection fraction, LV function and NHYA class to evaluate any improvement in QoL post-surgery. Work by Goldsmith et al. (2001) revealed signicant improvement in QoL following mitral valve repair but noted impaired LV function or end­systolic dimension is less likely to aid improve­ment in QoL. Likewise he presented higher NYHA functional score being independent pre­dictor of low improvement in QoL and general health status post mitral valve surgery. Conversely Zhao etal. [27] reported signicant improvement
in NYHA class and health status for mitral repair patients.
Other Determinants ofQuality ofLife
Type ofProsthesis
Prosthesis type was reported as another impor­tant indicator of QoL post-operatively. Some studies have pointed out that even though surgery improves QoL, certain prosthesis result in better gains than others. One example is the research done by Florath etal. (2005) who have concluded that elderly patients receiving a stentless bio­prosthetic aortic valve had a greater gain in the emotional QoL component due to the avoidance of warfarin [28]. This point was further supported by Zacek et al. [29] who stated QoL post­operatively is inuenced by the specic type of aortic valve and greater quality of life and free­dom is preserved by procedures that avoid life­long anticoagulation.
On the other hand Vicchio et al. [30] found that while survival in selected octogenarians was similar to the general elderly population, quality of life was not inuence by the type of aortic
206
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Y. S. Abdullahi et al.
valve used—that is to say, there was no differ­ence in quality of life between patients with bio­prosthetic or mechanical valves.
Type ofSurgery
QoL following mitral valve surgery has been a closely followed topic. Much of the literature suggests that patients undergoing mitral repair experiencing a greater QoL improvement whereas mitral valve replacement yield inferior QoL gains [31]. Interestingly, Jokinen et al. (2007) assert that their research indicated qual­ity- of life post-operatively was not signicantly different between mitral valve replacement or repair, whereas survival was longer after mitral valve replacement as compared to repair. Furthermore, when compared to an age- and sex­matched population, scores around energy and mobility were lower. Juxtaposed to this, Maisano et al. [23] found that quality of life following mitral valve surgery is suboptimal in almost half of all elderly patients, particularly those with residual mitral regurgitation.
Transcatheter aortic valve implantation (TAVI) has been used for over a decade as a less invasive option for those who cannot undergo SAVR due to high risk of surgical complications. Following continuous advancements in TAVI technology with the aim of reducing complica­tions, the use of TAVI has been extended to patients for whom SAVR is considered suitable but poses a high risk and also intermediate and lower risk patient populations, including younger patients with fewer comorbidities [45].
The all-cause mortality up to 5 years of fol­low- up did not differ signicantly between TAVI and SAVR in patients surgically operable at a high risk, but favoured TAVI over medical ther­apy in patients surgically inoperable. Although TAVI was non-inferior to SAVR inpatients surgi­cally operable at a high risk, shorter term benets were observed for those patients undergoing TAVI regarding QoL, NYHA classication, over­all incidence and severity of prosthesis-patient mismatch and lower incidence of acute kidney injury [4547].
QoL after MVr and MVR improves. Improvement in QoL after surgery was seen in elderly group, asymptomatic and ischaemic mitral regurgitation patient. Though not conclu­sive, MVr showed more improvement in QoL especially over the rst year. The use of robotic or mini mitral approach also confers benets to post operative QoL [5961, 64].
Incision Factor
The impact of full sternotomy on patient’s post­operative quality of life and the perceived benet of minimally invasive approach were investigated by Detter and colleagues [32] in their study of 140 patients that were separated equally to their respective cohort (minimal vs. conventional) group, and with a mean age 64.3 years and 34months follow-up.
Interestingly they presented the absence of any signicant difference between the two groups in any of the 8 domains of the quality of life tool used (SF 36). Furthermore, they reported patient’s satisfaction and scar judgement after the opera­tion was not inuence by the incision style. None the less their study has few limitations and to begin with their postop follow-up was not done at 3 months or at 12 months, hence they haven’t reported early mobilisation or the stability of the sternum at any given point. Similarly, their post­ op complication list didn’t not account for surgi­cal site infection on which case if considered and reported it may have inuence the patient’s satis­faction and quality of life results [32].
There was uncertainty on mortality or extra­corporeal support times with upper hemi­sternotomy for aortic valve replacement compared to full median sternotomy. The evi­dence to support a reduction in total hospital length of stay or intensive care stay was low in quality. There was also uncertainty of any differ­ence in the rates of other, secondary outcome measures or adverse events (blood loss, deep sternal wound infection, pain scores, QoL(SF-36), post-op AF, re-exploration) with minimally inva­sive limited sternotomy approaches to aortic valve replacement [5458, 68].
10 The Impact ofValve Surgery ontheHealth-Related Quality ofLife ofElderly Patients: Systematic Review
207
Limitation
In conducting this review, multiple limitations must be acknowledged. While some of the stud­ies reviewed were prospective in nature, many were retrospective (see table of studies above). Similarly, many studies were single centre, which can affect the generalisability of results. Quality analysis demonstrated some of the most common aws in the studies – namely patient selection, which must be acknowledge is largely due to ethical and technical consideration rather than poor selection.
We were specically interested in identifying predictors of poor QoL gains post-operatively, and given the paucity of data around the subject, this was particularly difcult. In all of the litera­ture identied, only few studies directly broached this topic. This provides a bottleneck in terms of validating the ndings of these arti­cles as well as limiting the scope of other poten­tial factors which can negatively affect QoL post-operatively.
Conclusion
Increases in average population age across developed countries means there is a greater prevalence of valvular heart disease. Elderly patients can safely undergo valvular surgery with excellent post-operative outcomes. While mortality and morbidity are both important measures of operative success, it is imperative that a quality of life measure be included when evaluating the success of valvular surgery in elderly patients. Our literature review identi­fied that quality of life gains post-operatively for elderly patients undergoing valvular heart surgery are both evident and significant when compared to pre-operative state. In saying that, we identified certain factors which can be correlated to limited QoL improvement— these included prosthetic type, valve dimen­sions, renal failure, AF, LV dysfunction, gender, NYHA score and replacement as com­pared to repair in mitral valve surgery (Fig.10.3).
Conclusion
• Variety of tools to measure QoL make Comparing across studies difficult
• Risk factors like diabetes, LV function, Gender, renal failure negatively impact post -op QoL
• Limited upper sternotomy may benefit in regards to secondary endpoints
• TAVI approach helps QoL in the first year
• QoL similar to between TAVI and SVAR by I year
• QoL improve after MVR but possibly more after MVr
• Mini Mitral approach allows for better QoL over the first 12 months
Fig. 10.3 Conclusions
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Quality ofLife After Mitral Valve
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andTricuspid Valve Surgery
NicolaDi Bari, MarcoMoscarelli, GiuseppeNasso, andGiuseppeSpeziale
11
Quality ofLife After Mitral Valve Surgery
Introduction
Recent years have seen a rising interest in mea­suring quality of life (QoL) as an outcome of car­diac surgery for mitral valve repair/replacement rather than focusing solely on postoperative mor­bidity and mortality. Consistent with available guidelines [1], the current clinical trend is to treat severe degenerative mitral disease surgically in the early phase when patients are still asymptom­atic. Earlier treatment makes preserving patient QoL a high priority and an important benchmark for procedural success.
Alongside a focus on postoperative QoL, car­diac centers are increasingly opting for mini­mally invasive surgical approaches as a way to minimize surgical risk. Recent strides forward in surgical technique have made fully endoscopic mitral valve repair/replacement a safe, common procedure that produces similar outcomes to the
N. Di Bari (*) Division of Cardiac Surgery, Department of Emergency and Organ Transplant, Policlinico Hospital, University of Bari, Bari, Italy
M. Moscarelli · G. Nasso · G. Speziale Department of Cardiovascular Surgery, GVM Care & Research Anthea Hospital, Bari, Italy e-mail: m.moscarelli@imperial.ac.uk;
gnasso@libero.it; gspeziale@gvmnet.it
sternotomy approach in terms of morbidity and mortality. To this end, it is imperative to examine QoL as an additional important outcome of mini­mally invasive and percutaneous procedures, as has been recently done for traditional surgical approaches.
Methods forAssessing theQuality ofLife
Several instruments are used to measure QoL after cardiac surgery. Generic tools (i.e., non­disease specic tools) include the Short-Form (SF) 36 [2], RAND SF-36 [3], SF-12 [4], Linear Analogue Scale Assessment [4], 6-Domain Australian QoL Index [5], Nottingham Health Prole Questionnaire [6], Patient Component of the Global Assessment [7], and the EuroQoL-5D [8]. Disease-specic tools include the Minnesota Living with Heart Failure Questionnaire (MLHFQ) [9], Kansas City Cardiomyopathy Questionnaire (KCCQ) [7], and Duke Activity Status index (DASI) [10]. These instruments can be used individually or in combination to assess QoL as an outcome of cardiac surgery.
The most widely used assessment among studies reported in the literature is the SF-36. Advantages of the SF-36 questionnaire include its brevity (on average, the survey takes no longer than 10min to complete) and precision (validity and reproducibility). The 36 questions of the
© Springer Nature Switzerland AG 2022 T. Athanasiou et al. (eds.), Patient Reported Outcomes and Quality of Life in Cardiovascular Interventions,
https://doi.org/10.1007/978-3-031-09815-4_11
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Predictors of impared health-related quality of life (HRQOL) improvement.
N. Di Bari et al.
SF-36 are subdivided into 8 different scales and 2 indices that summarize physical and mental health. A higher score indicates better self­perceived health. With regard to disease-specic scales, the KCCQ is most widely used and is structured in 23 items representing 6 dimensions, with higher scores indicating better QoL.
Negative Predictors ofQuality ofLife
In most studies, variables that negatively inu­ence QoL after mitral valve surgery are female sex, older age, and higher New York Heart Association (NYHA) class [11, 12]. Other fac­tors such as coronary heart disease (and associ­ated risk factors) and previous myocardial infarction also negatively impact QoL in this con­text (Fig.11.1).
In one study, Ay etal. [2] reported that preop­erative atrial brillation, oral anticoagulation, peripheral vascular disease, and female sex nega­tively inuenced mental score. Similarly, Maisano etal. [13] identied preoperative atrial brillation, diabetes mellitus, high creatinine level, Euroscore, degree of mitral insufciency (MI), and pulmonary artery pressure as negative predictors after mitral valve surgery.
Quality ofLife inRelation toProsthesis Type andSurgical Approach
Biological Versus Mechanical Heart Valve Replacement
In a study conducted by Molero Junior et al. [14], QoL was assessed using the SF-36in 36 patients (16 men, mean age 51 years) who underwent mitral valve replacement surgery. The authors found that prosthesis type did not inuence postoperative QoL after an average follow-up period of 32.5months. In contrast, a recent study of 150 patients by Huang et al. [15] found that mechanical mitral valve replace­ment with the ATS valve (ATS Medical, Inc., Minneapolis, Minn) was associated with better QoL at discharge (determined using the Chinese version of the SF-36) compared to replacement with the Sorin and St. Jude Medical (SJM) valves, although this difference gradually decreased at 3 and 12 months of follow-up. Another study by the same group [16] com­pared postoperative QoL after replacement with the Star GK (85 patients) and SJM (87 patients) and found no signicant difference between groups.
Predictors of Impaired HRQOL after mitral valve intervention
Patient factors Surgical factors
Higher NYHA Class Replacement instead of repair
Female
Increasing age
Previous myocardial infarction
Atrial fibrillation
Higher EuroSCORE
Risk factors for CAD
Peripheral vascular disease
Diabetes
Fig. 11.1 Predictors of Impaired HRQOL after mitral valve intervention.
Elevated trans-mitral gradient
Residual mitral regurgitation
Use of mechanical instead of bioprosthetic valves
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Conventional Mitral Valve Intervention (Surgical Repair or Replacement) Via Median Sternotomy
Several studies have reported the use of single assessment tools in patients undergoing conven­tional mitral repair or replacement surgery with median sternotomy. In general, patients exhibit improvements in QoL during the postoperative period with scores similar to or even higher than the normal population, especially for the physical component [6, 17, 18]. Some studies illustrate this effect to be larger in patients undergoing repair rather than replacement [9, 19]. On the other hand, a prospective randomized study iden­tied no signicant difference in postoperative QoL after repair versus replacement, even in patients with moderate or severe MI at follow-up [10].
Hansen etal. [11] found that QoL improved in all patients (n = 663) undergoing conventional valve repair surgery regardless of etiology. Moreover, patients treated for mitral degenera­tion showed a higher physical well-being score than a population sample matched for age and gender. Patients with idiopathic dilated cardio­myopathy had the worst QoL scores at follow-up, especially if they were women, despite higher comorbidities among men.
Conventional Mitral Valve Interventions (Surgical Repair or Replacement) versusMinimally Invasive Approach
In two studies comparing patients undergoing conventional versus minimally invasive mitral valve surgery, QoL (assessed using the SF-12 and SF-36, respectively) was superior in patients undergoing minimally invasive surgery at short­term follow-up, but there was no difference dur­ing long-term follow-up [20, 21]. Similarly, Suri etal. [20] identied a benet of robotic surgery to conventional surgery during the rst year of fol­low- up, but observed no signicant difference at 12 or 24months. Nasso et al. [21] conducted a
randomized controlled trial in 160 patients with Barlow’s disease and found that patients under­going minimally invasive mitral surgery had bet­ter physical activity and general well-being at 6 months, but there was no benet in terms of SF-36 score at 1year. Two other studies similarly detected no difference in QoL outcomes after conventional versus minimally invasive proce­dures beyond the immediate postoperative period [4, 22]. These studies do however conrm the non-superiority of minimally invasive surgery to conventional surgery for postoperative QoL, sup­porting the adoption of minimally invasive sur­gery as the gold standard for mitral repair/ replacement at many cardiac surgery centers.
A recent study by Zhao etal. [23] compared QoL measured with the SF-12 at 30 days and 6 months after mitral valve replacement with a robotic (da Vinci) versus conventional approach (47 patients in each group). In this study, QoL was initially better in the robotic group, but this difference diminished at 6months. However, the robotic approach is less invasive, favors quick postoperative recovery, and has higher patient satisfaction.
Another study retrospectively compared the effect of fully endoscopic versus conventional mitral surgery on QoL in a population of 163 patients using the Chinese version of the Medical Outcome Study (MOS) SF-36. At 3months fol­low- up, the authors noted a signicant group dif­ference in bodily pain and mental pain scores in favor of the minimally invasive group. In conclu­sion, compared to median sternotomy, endo­scopic surgery has a noninferior therapeutic effect and improves QoL with a better cosmetic effect and lower pain [5].
MitraClip Implantation
Edge-to-edge percutaneous mitral repair signi­cantly reduces mitral regurgitation with a low complication rate in patients with severe MI who are not eligible for conventional surgery. Many studies in the literature have reported a signicant improvement in QoL among patients receiving a MitraClip implant [2426]. In a
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N. Di Bari et al.
study by Agata Krawczyk-Ożóg etal. [27], the MitraClip was compared to conventional con­servative treatment in 33 patients with severe mitral regurgitation on a functional basis, as the efcacy and benet of this procedure is not yet fully established. Compared to conservative treatment, MitraClip implantation improved the clinical condition of patients measured as sig­nicant decrease in NYHA class; reduced the extent of regurgitation, effective regurgitant ori­ce area of the vena contracta, regurgitation volume, and end diastolic left ventricular diam­eter; and improved QoL measured on the EQ-5D-3L and SF-12v2 at a mean follow-up of
8.0 ± 2.3 months. Other studies have reported no signicant difference between the MitraClip implant and conventional surgery in this context [28, 29].
In a cohort study used by the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry, Arnold etal. [7] analyzed data from patients with severe MI treated between 2013 and 2017 at 217 US hospitals and measured changes in disease­specic health status (KCCQ-Overall Summary [OS] score; range 0-100 points, with higher scores indicating better health status) at 30days and 1year after the procedure. Risk factors asso­ciated with 30-day KCCQ-OS were also evalu­ated. KCCQ data were available from 81.2% of patients at baseline, 69.3% of survivors at 30days, and 47.4% of survivors at 1year. Among 4226 patients who underwent transcatheter mitral valve repair, KCCQ-OS increased from 41.9 before the procedure to 66.7 at 30days and scores remained stable to 1year post-procedure. In the multivariable analysis, atrial brillation, perma­nent pacemaker, severe lung disease, home oxy­gen, in-hospital renal failure, and lower KCCQ-OS scores at baseline were independently associated with lower 30-day KCCQ-OS scores. In estimates calculated with inverse probability weighting, 54.2% of patients were alive and well at 1-year follow-up, 23.0% had died, 21.9% had persistently poor health status (KCCQ-OS <60 points), 5.5% had a health status decline from baseline, and 4.6% had both poor health status and health status decline.
Other Percutaneous Mitral Valve Interventions
With regard to other percutaenous interventions, studies have demonstrated improvements in QoL after implantation with the Carillon Mitral Countou System [8, 30].
The Viacor percutaneous transvenous mitral annuloplasty device was used in one study, but the trial was terminated prematurely due to peri­operative complications and no observable improvement [31].
A study by Barth etal. [32] examined QoL at 5 months after treatment with the PASCAL device in 31 patients: 63% had functional MI, 29% had degenerative disease, and 9.7% had mixed etiology. Eighty-seven percent of the cohort completed follow-up including the KCCQ and EuroQoL5D.The authors detected postoper­ative QoL improvements of 31 and 9 points, respectively, supporting safety and efcacy of the device. Another work by Lim etal. [33] used the same QoL measures and identied improvements of 17 and 10 points, respectively, in 62 patients at 30days after PASCAL device implantation.
Finally, a study by Okoh etal. [34] evaluated QoL in 15 patients undergoing transcatheter valve-in-valve implantation for previous biologi­cal valve degeneration using the Sapien XT, Sapien, or Sapien S3 and reported QoL improve­ment in 10 out of 11 patients evaluated at 30days follow-up.
Quality ofLife After Tricuspid Valve Surgery
Severe tricuspid insufciency is relatively com­mon and higher severity is associated with higher morbidity and mortality. Treatments for isolated forms are limited. For most patients, both medi­cal therapy and conventional surgery can be effective; however, transcatheter repair surgery has become a treatment of choice and produces signicant improvements in QoL and mortality. Davidson etal. [35] reported outcomes of rst­time treatment with the Cardioband device in US cohort of 30 patients and found that 75% of
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patients were NYHA class I or II and showed a KCCQ score improvement of 16 points at 30 days follow-up. Another study by Nickenig etal. [36] demonstrated an increase in follow-up KCCQ score of 14 points after the same procedure.
Guillem Muntanè-Carol etal. [37] described an initial experience with the FORMA device for transcatheter tricuspid repair in high-risk patients. Patients showed signicant improvements in both heart disease symptoms and QoL.Positive results were also obtained with the TrialignTM device, which represents a new percutaneous tri­cuspid annuloplasty technique for functional insufciency [38]. The edge-to-edge transcathe­ter technique has also been shown to be safe and effective for reducing tricuspid insufciency and improves QoL by 16% [39].
Although there is considerable clinical experi­ence with transcatheter repair in the literature, repair is not possible or may not optimally reduce the severity of tricuspid regurgitation in a large number of patients. A large coaptation gap (>6–8 mm) and non-central regurgitant jets are associated with poor procedural success. Moreover, the presence of calcication and immobile or severely retracted leaets (espe­cially the septal leaet) with extensive tenting distances are also negative predictors of outcome after repair. Transcatheter replacement is the pre­ferred treatment option in cases of moderate or severe tricuspid regurgitation after repair. Valves currently in use include orthotopic types (Cardiovalve, Evoque, Lux-Valve, Navigate, TriSol, Intrepid, TriCares) and heterotopic types (Sapien XT, TricValve, Tricento), both of which appear to positively inuence QoL [40].
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