Bevezetés: Napjainkban a súlyos panaszos aortastenosis kezelésében a transzkatéteres billentyűimplantáció a sebészi billentyűcsere elérhető alternatíváját jelenti sebészi kontraindikáció és elfogadhatatlanul magas műtéti kockázat esetén. A szerzők intézetében ez a beavatkozás ma már a mindennapi rutin részének számít. Célkitűzés: A szerzők az első 200, transzkatéteres billentyűimplantációban részesült beteg eredményeit tárgyalják. Módszer: 2016. januárig 200 sikeres implantáció történt. A betegek 55%-a nő, átlagéletkoruk 79,9 év volt, az átlagos EuroSCORE: 19,3%, az át-lagos ejekciós frakció: 54%, az aortabillentyűn mérhető csúcsgradiens 81,2 Hgmm, az átlaggradiens: 50,9 Hgmm volt. Eredmények: A beavatkozásokat 99%-os sikeraránnyal végezték, a szövődmények feldolgozása a VARC-2 kritéri-umrendszer alapján történt. Az egy hónapos mortalitás 5%, az egyéves pedig 17,4% volt, utóbbiból a kardiális mortalitás 13,6% volt. Az egyéves cerebrovascularis történések előfordulása 5% volt. Az egyéves kontroll során a betegek 95%-a NYHA I vagy II funkcionális állapotban volt. Következtetés: Az eredmények nem térnek el lényegesen a nemzetközi vizsgálatok eredményeitől. Orv. Hetil., 2016, 157(45), 1786-1792. Kulcsszavak: aortastenosis, transzkatéteres billentyűimplantáció The first 200 transcatheter aortic valve implantations in the Gottsegen György Institute of Cardiology, HungaryIntroduction: Transcatheter aortic valve implantation is a therapeutic alternative for contraindicated and high surgical risk patients with severe symptomatic aortic stenosis. This intervention is part of daily routine in the Institute of the authors. Aim: In the present work the results of the first 200 patients are discussed. Method: Until January, 2016, 200 patients (female 55%, mean age 79.9 years, average EuroSCORE 19.3%, left ventricular ejection fraction 54%, peak gradient 81.2 mmHg, mean aortic gradient 50.9 mmHg) underwent transcatheter aortic valve implantation. Results:The procedure was performed with 99% success rate. Complications were evaluated according to VARC 2 definitions. Mortality was 5% at one month and 17.4% at one year. Cardiac mortality was 13.6 at one year. Cerebrovascular complications were 5% within one year, and 95% of patients were in NYHA I or II functional classes at one year. Conclusion: These findings are consistent with worldwide results.
Surgical aortic valve replacement in the elderly is now being supplanted by transcatheter aortic valve implantation (TAVI). Scoring systems to predict survival after catheter-based procedures are understudied. Both diabetes (DM) and underlying inflammatory conditions are common in patients undergoing TAVI, but their impact remains understudied in this patient group. We examined 560 consecutive TAVI procedures and identified eight pre-procedural factors: age, body mass index (BMI), DM, fasting blood glucose (BG), left-ventricular ejection fraction (EF), aortic valve (AV) mean gradient, C-reactive protein levels, and serum creatinine levels and studied their impact on survival. The overall mortality rate at 30 days, 1 year and 2 years were 5.2%, 16.6%, and 34.3%, respectively. All-cause mortality was higher in patients with DM (at 30 days: 8.9% vs. 3.1%, p = 0.008; at 1 year: 19.7% vs. 14.9%, p = 0.323; at 2 years: 37.9% vs. 32.2%, p = 0.304). The presence of DM was independently associated with increased 30-day mortality (hazard ratio [HR] 5.38, 95% confidence interval [CI], 1.24–23.25, p = 0.024). BG levels within 7–11, 1 mmol/L portended an increased risk for 30-day and 2-year mortality compared to normal BG (p = 0.001 and p = 0.027). For each 1 mmol/L increase in BG 30-day mortality increased (HR 1.21, 95% CI, 1.04–1.41, p = 0.015). Reduced EF and elevated CRP were each associated with increased 2-year mortality (p = 0.042 and p = 0.003). DM, elevated BG, reduced EF, and elevated baseline CRP levels each are independent predictors of short- and long-term mortality following TAVI. These easily accessible screening parameters should be integrated into risk-assessment tools for catheter-based aortic valve replacement candidates.
Background Outcomes for different subtypes of aortic stenosis defined by transvalvular flow and gradient after transcatheter aortic valve implantation (TAVI) are still subjects of debate. Purpose The aim of the study was to evaluate the prognostic impact of the initial transvalvular flow rate and aortic mean gradient on survival and to assess the changes of left ventricular function after TAVI. Patients and Methods From 2008. to 2017.06.30. TAVI was performed in 300 cases in our Institute (127 men, 173 women, mean age 80,0 ± 5,8 years) with severe (aortic valve area <1,0 cm²) symptomatic aortic stenosis (AS) and contraindication or high risk for surgery. Median time for follow-up was 28 (0-115) months, Echocardiography was performed before and 12 months after TAVI. Patients were divided into four groups according to flow (F) , aortic mean gradient (Gr) and ejection fraction (EF): HG Gr ≥ 40 mmHg (n = 237) LF-LG : F ≤ 35 ml/m2, Gr < 40 mmHg and EF < 50% (n = 41) PLF-LG: F ≤ 35 ml/m2, Gr < 40 mmHg and EF ≥50% (n = 9) NF-LG: F > 35 ml/m2 and Gr < 40 mmHg (n = 13) Our primary objective was the analysis of 30-day, 1-year and 3-year all-cause mortality of these groups, secondary goal was to observe the changes in EF after 12 months in the survivors. Results In the whole patient group 30-day all-cause mortality was 4,3%, 1-year 17,0% and 3-year 62,0%. The NFLG group had the most favourable outcomes (mortality: 30d 0, 1-year: 7,7%, 3-year: 46,2%). Mortality was low in the HG group in the 1st year (30-day: 3,8%, 1-y: 14,3%), but it increased to 62,8% at 3-year. Mortality rates were intermediate in the PLF-LG group (30-day 0, 1-year 22,2%, 3-year 55,6%) and were the highest in LF-LG (30-day 12,2%, p = 0,03 vs HG, 1-year 34,2% p = 0,005 vs. HG, 3-year 75,6%). Among clinical and echocardiographic variables only moderate or severe paravalvular aortic regurgitation (p = 0,03) and severe renal dysfunction (GFR <30 ml/min, p = 0,02) were independent predictors of all-cause 1-year mortality. In patients with severe (EF < 30%) , moderate (EF 30-40%) or mild ( EF 41-50%) systolic dysfunction the EF improved after TAVI (23,5 ± 3,5% vs. 30,3 ± 7,9% p < 0,001, 33,6 ±3,6% vs. 43,0 ± 10,5% p = 0,003, 45,5 ± 3,1% vs. 54,3 ± 8,7% p < 0,001) regardless of the initial flow and gradient subtype of AS. Conclusions Low flow-low gradient aortic stenosis is associated with worse short or long term prognosis after TAVI, therefore this subtype of AS needs detailed risk stratification before-, and careful management after TAVI. Improvement of initial left ventricular dysfuncion can be expected after TAVI.
Calcified aortic stenosis is the most common valve disease in the developed world. Transcatheter aortic valve implantation (TAVI) represents an available treatment option in patients with severe aortic stenosis who were not suitable or at extremely high risk for traditional surgical valve replacement. The present study reviews the most important historical milestones and trials of TAVI as it is used in our days. We discuss the present role of the procedure from indication to implantation.
Összefoglaló. Bevezetés: A transzkatéteres aortaműbillentyű-beültetés (TAVI) az idős, súlyos aortastenosisban szenvedő, multimorbid, magas műtéti kockázattal rendelkező betegek esetében javasolt a szívsebészeti aortaműbillentyű-beültetés alternatívájaként. Célkitűzés: Jelen munkánkban az intézetünkben elindult TAVI-program első 10 éve alatt elvégzett 463, TAVI-n átesett beteg rövid és hosszú távú eredményeit tekintjük át és értékeljük. Külön vizsgáljuk az első 200 beteg és az utánuk következő 263 beteg eredményeit. Módszer: 2008. november 11. és 2018. december 31. között 463 betegnél végeztünk TAVI-t. Betegeink átlagéletkora 79,6 év, átlagos logisztikus EuroSCORE-értékük 19,0%, átlagos STS-score-értékük pedig 5,2% volt. A beavatkozás előtt az esetek 72%-ában NYHA III-as vagy IV-es funkcionális stádiumban voltak. A beavatkozások 92,8%-át transfemoralis behatolásból végeztük. Az aortabillentyűn mért átlagos gradiens 50 Hgmm, a billentyűarea 0,55 cm2 volt. Az esetek mintegy 2%-ában az aortabillentyű-bioprotézis restenosisa miatt „valve-in-valve” beavatkozást végeztünk. Eredmények: A TAVI után a 30 napos halálozás 5,2%, az 1 éves pedig 16,4% volt. A TAVI-t követően kialakult szövődményeket a VARC-2 kritériumrendszere alapján értékeltük. A beavatkozás után 2,2%-ban fordult elő major stroke. A leggyakoribb szövődmény, a posztoperatív pacemakerimplantáció (19,9%) aránya szignifikánsan csökkent a később TAVI-n átesett 263 beteg esetében (26,5% vs. 14,8% [p = 0,002]). A vérzéses szövődmények aránya a percutan beavatkozások bevezetésével szignifikánsan emelkedett ugyan (10% vs. 20,2% [p = 0,016]), de ez nem járt a mortalitás emelkedésével. Következtetés: Az eredmények alapján elmondhatjuk, hogy a TAVI intézetünkben is biztonságos alternatívát jelent a magas műtéti rizikóval rendelkező, súlyos, tünetes aortastenosisban szenvedő betegek esetében. Orv Hetil. 2022; 163(6): 229–235. Summary. Introduction: Transcatheter aortic valve implantation (TAVI) is an alternative treatment to surgical aortic valve replacement for elderly, high surgical risk patients. Objective: The aim of this study was to evaluate the short- and long-term outcomes of those 463 patients who underwent TAVI during the first 10 years in our TAVI program. We compare the first 200 patients’ results with the further 263 patients’ results. Method: Between 11th November 2008 and 31st December 2018, 463 patients underwent TAVI. The average age of the patients was 79.6 years, the average logistic EuroSCORE was 19.0%, the average STS score was 5.2%. 72% of the patients were in NYHA III or IV stage before TAVI. 92% of TAVIs were performed from femoral arteries. Average mean gradient was 50.0 mmHg and aortic valve area was 0.55 cm2, respectively. In 2% of the cases, “valve-in-valve” intervention was performed because of the restenosis of former aortic valve prosthesis. Results: 30-day mortality was 5.2% and the 1-year mortality was 16.4% after TAVI. Post-TAVI complications were evaluated according to the VARC-2 definitions. Major stroke occurred in 2.2% after TAVI. The most common complication was pacemaker implantation (19.9%), but their incidence was significantly reduced between the 2 groups (26.5% vs. 14.8% [p = 0.002]). The incidence of vascular access site complications was significantly higher between the 2 groups (10% vs. 20.2% [p = 0.016]), but it did not affect the mortality. Conclusion: Based on our results, TAVI is a safe alternative treatment for patients with severe, symptomatic aortic stenosis in our institute as well. Orv Hetil. 2022; 163(6): 229–235.
Introduction The role of fractional flow reserve (FFR) measured directly after drug eluting stent (DES) implantation (post-PCI FFR) is not clear in predicting major adverse cardiac events (MACE), and it is not known which clinical parameters affect post-PCI FFR. Aim We aimed to clarify the relationship between post-PCI FFR and clinical parameters, post-PCI FFR and long-term MACE and determine the best post-PCI FFR cut-off in MACE prediction. Method Patients who underwent post-PCI (DES) FFR measurement at our center between March 2009 and January 2021 were included. We examined the relationship between post-PCI FFR and gender, age, hypertension, diabetes mellitus, hyperlipidemia, indication (acute (ACS) vs. chronic coronary syndrome (CCS)), stent diameter, in-stent restenosis vs de novo lesion category, proximal vs. non-proximal lesion location, LAD (vs. non-LAD) location, and pre-PCI FFR. We sought to determine the correlation between post-PCI FFR and target vessel-related MACE (cardiovascular death (CVD), non-fatal myocardial infarction (MI), recurrent revascularization (TVR)). Optimal cut-off was determined by ROC curves. Results Post-PCI FFR measurement was performed in 500 coronary arteries of 434 patients. LAD location (0.86 vs. non-LAD 0.91, p<0.001), male gender (0.87 vs. 0.89, p=0.001), younger age (p=0.0215), smaller stent diameter (p=0.0028) and lower pre-PCI FFR (p=0.0006) proved to be independent predictors of lower post-PCI FFR, no other parameter showed a significant correlation with post-PCI FFR. During a median follow-up of 37 months, 24 CVD, 15 MI and 47 TVR occurred. Follow-up was complete in 96.2% of patients. There was a significant inverse correlation between post-PCI FFR and MACE (p<0.001). Diabetes mellitus (p=0.0024) and in-stent restenosis (0.0356) were also independent predictors of MACE. The best post-PCI FFR cut-off for the total patient population, LAD and non-LAD lesions were 0.83 (p<0.0001), 0.83 (p<0.0001), and 0.88 (p=0.0091), respectively. Conclusion LAD location, male gender, younger age, smaller stent diameter and lower pre-PCI FFR value result in lower post-PCI FFR. There is no significant difference between post-PCI FFR measured in ACS vs. CCS. FFR measured after PCI, diabetes mellitus and in-stent restenosis are significant predictors of MACE-free long-term survival. The best post-PCI FFR cut-off to predict MACE was 0.83 for the whole patient population and for LAD and 0.88 for non-LAD lesions. Funding Acknowledgement Type of funding sources: None.
PurposeOutcomes for different subtypes of aortic stenosis (AS) after transcatheter aortic valve implantation (TAVI) are still subjects of debate. The aim of the study was to evaluate the prognostic impact of baseline flow rate (F) and mean gradient (G) on survival after TAVI. MethodsFrom 2008. to 06. 2017. TAVI was performed in 300 cases (127 men, 173 women, age 80,0±5,8 years) with severe AS. Follow-up was at least 3 years. Mortality tracking was 100%. Patients were divided into high gradient (HG: 237), low-flow low-gradient (LF-LG: 41), paradoxically low flow-low gradient (PLF-LG: 9) and normal flow-low gradient (NF-LG: 13) groups. Primary endpoint was 30-day, 1-year and 3-year all-cause mortality (M) . ResultsNF-LG had better prognosis (M: 30d 0, 1-year: 7,7%, 3-year: 46,2%). In HG patients mortality was low in the 1st year (30-day: 3,8%, 1-y: 14,3%), but higher (62,8%) after 3 year. PLF-LG had intermediate outcomes (30-day 0, 1-year 22,2%, 3-year 55,6%). LF-LG had the highest mortality (30-day 12,2%, p=0,03, 1-year 34,2% p=0,005, 3-year 75,6% p=0,009 vs.HG) and relative risk (2,44 [1,34-4,42] p=0,003 vs.HG). Independent predictors of 1-year mortality were only Grade 2+ paravalvular regurgitation (p=0,04) and severe renal dysfunction (p=0,04). ConclusionsTAVI survival is determined by the guideline-defined subtype of AS. Low flow – low gradient AS is associated with worse prognosis, therefore these patients need careful management after TAVI.
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