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Title:
The role of balloon aortic valvuloplasty in the treatment of severeaortic stenosis
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surgical aortic valve replacement ; transcatheter aortic valveimplantation ; aortic stenosis ; balloon aortic valvuloplasty
Abstract:
Aortic stenosis (AS) is the most frequent acquired valve disease indeveloped countries. The prevalence of AS in the elderly (>75 yearsold) is 12.4% of whom 3.4% have severe AS. Severe symptomatic ASis associated with a poor prognosis, as most patients die within 2–3years of diagnosis. Aortic valve replacement (AVR) is the preferred treatment of symptomatic AS but unavailable for many patients due to high procedural risk. Transcatheter aortic valve implantation (TAVI)and balloon aortic valve valvuloplasty (BAV) are less invasiveprocedures as compared to surgery. TAVI is now given particularprominence in the group of high-risk patients as an acceptablealternative to AVR, with reported improvement in the quality of lifeand clinical outcomes. According to the European Society ofCardiology (ESC) guidelines for the management of valvular heart disease, BAV may be considered as a bridge to surgery or TAVI inhaemodynamically unstable patients who are at high risk for surgery,or in patients with symptomatic severe AS who require urgent major non-cardiac surgery (Class IIb, Level C). BAV may also be consideredas a palliative procedure in selected cases when both surgery andTAVI are contraindicated because of severe comorbidities. BAV maybe especially beneficial in those patients leading to temporaryimprovement of LVEF and requalification to TAVI/AVR. Etiology of degenerative AS reveals s ; imilarities to the etiology ofCAD in inflammatory and calcific processes. Therefore, in almost halfof the patients aged ≥70 years, newly diagnosed AS coexists withCAD. The ESC guidelines recommend to perform coronaryangiography before valvular heart surgery in case of any of thefollowing: history of CAD, suspected myocardial ischaemia, leftventricular systolic dysfunction, in men >40 years andpostmenopausal women, or in patients with ≥1 cardiovascular riskfactor (Class I, Level C). In patients with a primary indication foraortic valve surgery, coronary artery bypass grafting (CABG) remains the preferred treatment of CAD if coronary artery diameter stenosis is≥70% (Class I, Level C). Therefore, until recently, the standardtreatment option for patients with severe AS and concomitant CAD was AVR combined with CABG. After the introduction of TAVI, newcomplex models of treatment have been developed with the additionaluse of percutaneous coronary intervention (PCI) together with BAV.Nowadays patients with significant CAD scheduled for BAV/TAVIcan be treated with PCI at the time of BAV/TAVI (as a singleprocedure) or with staged PCI. The post-implantation paravalvularleak (PVL) remains an important TAVI-related complication worsening clinical outcomes. PVL is present in up to 70% of all patients undergoing TAVI, and more than mild PVL has been reported in approximately 10–15% patients. ; Angiography and echocardiography are the primary tools to quantify the degree of PVL.Balloon post-dilatation (PD) can reduce PVL by achieving a better expansion of the prosthesis and optimal sealing of the paravalvularspace.AimThe aim of this study was to determine procedural and clinicaloutcomes of patients with severe AS undergoing standalone BAV orBAV with coronary angiography/PCI and to evaluate the effects of balloon PD on the reduction of PVL and mortality in patients undergoing TAVI. ; Methods We included consecutive patients with severe symptomatic AS whounder went standalone BAV, BAV with coronary angiography/PCIand/or TAVI. All patients were qualified for invasive treatment by an interdisciplinary team of specialists (heart team). The procedural risk was estimated by the logistic European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) and the Society of Thoracic Surgeons Predicted Risk of Mortality (STS) score. The study was approved by the local ethical committee. Clinical and echocardiographic data were prospectively collected within 1, 6, and12 months follow-up after BAV or until received TAVI/AVR, re-BAVor death. Procedure Coronary angiography/PCI was guided by fluoroscopy. The same femoral retrograde approach was used in case of concomitant coronary angiography/PCI and then during BAV to reach in aortic valve under echocardiographic and fluorosco ; pic guidance. Vascular accesses wereclosed with Angio-Seal vascular closure device (St. Jude Medical,USA) or with manual compression. Baseline and procedural characteristics, as well as long-term outcomes were assessed in three groups - stand alone BAV, BAV with coronary angiography (only),and BAV combined with PCI. In case of TAVI after valve deployment angiography, echocardiography, and the aortic regurgitation index(ARI) were used to assess the severity of PVL before and after balloonPD. Patients were divided into two groups based whether or not PDafter TAVI was performed. Reduction of PVL, change of ARI, andclinical outcomes was assessed. ; Results In the first analysis, a total of 114 BAVs were performed in 112 patients. The leading indication for BAV was bridge for TAVI (n=58,51.8%). Others included bridge for AVR (n=6, 5.4%), palliative treatment (n=37, 33.0%), cardiogenic shock (n=2, 1.8%), and urgent non-cardiac surgery (n=9, 8.0%). To sum up, during follow-up, 23(20.5%) of patients after BAV underwent TAVI and 11 (9.8%)patients underwent AVR. A total of 89.3% of patients were in NYHAclass III or IV. Median of STS score was 8.0 (5.5-10.6)% andEuroscore II 8.1 (5.1-11.8)%. Vascular closure device was used in 37(33%) patients. Echocardiograms performed after BAV and at 1, 6, 12months showed that AVA was higher (+0.23, +0.15, +0.05, +0.05cm2, respectively, p<0.05 for all) ; and pAVG was lower -28.6, -24.4, -8.7, -4.8 mmHg, respectively, p<0.05 for all) as compared to baseline. In patients with impaired LV function n=34 (30.4%, LVEF< 40%) we observed significant improvement of LVEF (median +16%) after 1 month (p<0.05) and this effect was stable up to 6 months after BAV. There was one severe AR after 12 months and patient was successfully treated with TAVI. Major complications occurred in 21 patients: a) intraprocedural death (n=3), b) tamponade (n=2), c) severe AR (n=1),d) severe cardiac arrhythmias (n=5), e) permanent pacemaker implantation (n=1), f) need for red blood cells transfusion: 1 unit in 3 patients, 2 units in 5 patients, 4 units in 4 patients, 5 units in 1 patient(n=13). Vascular access site complications (VC) occurred in 11 patients (9.8%). Peri-procedural, in-hospital, 1-, 6-, 12-month mortality were 2.7%; 8.9%; 8.9 %; 16.9%; 22.3%, respectively. Inunivariate analysis females had higher prevalence of VC than males(14.3% compared with 2.4%, p=0.04). In multivariate logistic regression analysis, the only independent predictor of 12-month all causemortality was STS - HR (95% CI) 1.130 (1.038 to 1.231);p=0.05.In the second analysis of the 97 patients, 34 (35.0%) underwentstandalone BAV, 45 (46.4%) underwent BAV with coronary angiography and 18 (18.6%) BAV with PCI. Almost half of the patients who underwent BAV with PCI had a history of p ; revious PCI.A higher contrast load, radiation dose and longer fluoroscopy time in patients with concomitant PCI or coronary angiography were noted. No higher risk of complications after BAV performed with concomitant coronary angiography/PCI was observed. In spite of no difference in in-hospital mortality (5.6% vs. 8.9%; p=0.76), patients with BAV and concomitant PCI had lower long-term mortality than patients with BAV and concomitant coronary angiography (28.5% vs.51.0%; p=0.03). In multivariable Cox analysis adjusted for age, sex and body mass index, the STS Risk of Mortality score was identifiedas the only independent predictor of long-term mortality for all patients (HR 1.09, 95% CI 1.04-1.15; p=0.0006).In the third analysis, balloon PD after TAVI was performed in 23(22.8%) patients. In 95.6%, post-implantation PVL reduction was successful (no or mild PVL). PD increased ARI from 23.4% (22.4–24.0) to 27.1% (26.1–28.3); p < 0.001. Thirty-day mortality rate was14.1% in the PD (–) group vs. 0.0% in the PD (+) group; p=0.07. One-year mortality (21.8% vs. 4.3%; p=0.97) and procedural stroke rate(7.7% vs. 8.7%; p=0.99) were not different between the groups. ; Conclusions BAV is a useful procedure in high-risk severe AS patients, nevertheless limited by poor long-term outcomes. Limitations concern intermittent improvement of symptoms, echocardiographic and hemodynamic parameters. H ; owever, achieved effects can be sufficient in bridging patients for TAVI/AVR. Our study provides additional evidence that BAV in some patients results in recovery of initially depressed LVEF (<40%). Concomitant PCI or coronary angiography performed with BAV may not increase the risk of major and vascular complications of BAV. Patients with BAV and concomitant PCI mayhave better survival than patients with BAV and concomitant coronary angiography. Balloon PD may be a safe and effective technique toreduce moderate to severe PVL after TAVI.
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choroby układu krążenia ; kardiochirurgia