Browsing by Subject "STENOSIS"

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  • Moriyama, Noriaki; Laakso, Teemu; Raivio, Peter; Dahlbacka, Sebastian; Kinnunen, Eeva-Maija; Juvonen, Tatu; Valtola, Antti; Husso, Annastiina; Jalava, Maina P.; Ahvenvaara, Tuomas; Tauriainen, Tuomas; Piuhola, Jarkko; Lahtinen, Asta; Niemelä, Matti; Mäkikallio, Timo; Virtanen, Marko; Maaranen, Pasi; Eskola, Markku; Savontaus, Mikko; Airaksinen, Juhani; Biancari, Fausto; Laine, Mika (2021)
    Background: The data on acute kidney injury (AKI) in patients without chronic kidney disease (CKD) after transcatheter aortic valve replacement (TAVR) are limited. The study sought to compare the incidence of AKI and its impact on 5-year mortality after TAVR and surgical aortic valve replacement (SAVR) in patients without CKD. Methods: This registry included data from 6463 consecutive patients who underwent TAVR or SAVR. CKD was defined as estimated glomerular filtration rate Results: The study included 4555 consecutive patients (TAVR, n = 1215 and SAVR, n = 3340) without CKD. Propensity-score matching identified 542 pairs. Patients who underwent TAVR had a significantly lower incidence of AKI in comparison to those who underwent SAVR (unmatched 4.7% vs 16.4%, P <0.001, multivariable analysis: odds ratio, 0.29, 95% confidence interval [CI], 0.20-0.41; matched 5.9% vs 19.0%, P <0.001). Patients with AKI had significantly increased 5-year mortality compared with those without AKI (unmatched 36.0% vs 19.1%, log-rank P <0.001; matched 36.3% vs 24.0%, log-rank P <0.001). The adjusted hazard ratios for 5-year mortality were 1.58 (95% CI, 1.20-2.08) for AKI grade 1, 3.27 (95% CI, 2.09-5.06) for grade 2, and 4.82 (95% CI, 2.93-8.04) for grade 3. Conclusions: TAVR in patients without CKD was associated with a significantly less frequent incidence of AKI compared with SAVR. AKI significantly increased the risk of 5-year mortality after either TAVR or SAVR, and increasing severity of AKI was incrementally associated with 5-year mortality.
  • Venermo, Maarit; Sprynger, Muriel; Desormais, Ileana; Björck, Martin; Brodmann, Marianne; Cohnert, Tina; De Carlo, Marco; Espinola-Klein, Christine; Kownator, Serge; Mazzolai, Lucia; Naylor, Ross; Vlachopoulos, Charalambos; Ricco, Jean-Baptiste; Aboyans, Victor (2019)
    Peripheral arterial diseases comprise different clinical presentations, from cerebrovascular disease down to lower extremity artery disease, from subclinical to disabling symptoms and events. According to clinical presentation, the patient's general condition, anatomical location and extension of lesions, revascularisation may be needed in addition to best medical treatment. The 2017 European Society of Cardiology guidelines in collaboration with the European Society for Vascular Surgery have addressed the indications for revascularisation. While most cases are amenable to either endovascular or surgical revascularisation, maintaining long-term patency is often challenging. Early and late procedural complications, but also local and remote recurrences frequently lead to revascularisation failure. The rationale for surveillance is to propose the accurate implementation of preventive strategies to avoid other cardiovascular events and disease progression and avoid recurrence of symptoms and the need for redo revascularisation. Combined with vascular history and physical examination, duplex ultrasound scanning is the pivotal imaging technique for identifying revascularisation failures. Other non-invasive examinations (ankle and toe brachial index, computed tomography scan, magnetic resonance imaging) at regular intervals can optimise surveillance in specific settings. Currently, optimal revascularisation surveillance programmes are not well defined and systematic reviews addressing long-term results after revascularisation are lacking. We have systematically reviewed the literature addressing follow-up after revascularisation and we propose this consensus document as a complement to the recent guidelines for optimal surveillance of revascularised patients beyond the perioperative period.
  • Venermo, Maarit; Sprynger, Muriel; Desormais, Ileana; Björck, Martin; Brodmann, Marianne; Cohnert, Tina; Carlo, Marco De; Espinola-Klein, Christine; Kownator, Serge; Mazzolai, Lucia; Naylor, Ross; Vlachopoulos, Charalambos; Ricco, Jean-Baptiste; Aboyans, Victor (2019)
    Peripheral arterial diseases comprise different clinical presentations, from cerebrovascular disease down to lower extremity artery disease, from subclinical to disabling symptoms and events. According to clinical presentation, the patient's general condition, anatomical location and extension of lesions, revascularisation may be needed in addition to best medical treatment. The 2017 European Society of Cardiology guidelines in collaboration with the European Society for Vascular Surgery have addressed the indications for revascularisation. While most cases are amenable to either endovascular or surgical revascularisation, maintaining long-term patency is often challenging. Early and late procedural complications, but also local and remote recurrences frequently lead to revascularisation failure. The rationale for surveillance is to propose the accurate implementation of preventive strategies to avoid other cardiovascular events and disease progression and avoid recurrence of symptoms and the need for redo revascularisation. Combined with vascular history and physical examination, duplex ultrasound scanning is the pivotal imaging technique for identifying revascularisation failures. Other non-invasive examinations (ankle and toe brachial index, computed tomography scan, magnetic resonance imaging) at regular intervals can optimise surveillance in specific settings. Currently, optimal revascularisation surveillance programmes are not well defined and systematic reviews addressing long-term results after revascularisation are lacking. We have systematically reviewed the literature addressing follow-up after revascularisation and we propose this consensus document as a complement to the recent guidelines for optimal surveillance of revascularised patients beyond the perioperative period.
  • Saia, Francesco; Gandolfo, Caterina; Palmerini, Tullio; Berti, Sergio; Doshi, Sagar N.; Laine, Mika; Marcelli, Chiara; Piva, Tommaso; Ribichini, Flavio; De Benedictis, Mauro; Cardaioli, Francesco; Cannata, Stefano; Tarantini, Giuseppe (2020)
    Aims: The aim of this study was to evaluate 30-day safety and efficacy outcomes of transcatheter aortic valve implantation (TAVI) performed with the SAPIEN 3 Ultra system. Methods and results: The S3U registry is a physician-led, post-approval, multicentre, observational registry of transfemoral TAVI with the SAPIEN 3 Ultra. New features include an improved sealing skirt, a 14 Fr expandable sheath and a new delivery catheter. Overall, 139 consecutive patients at nine participating centres were enrolled. Mean age was 81.4 +/- 8.3 years, average STS score 3.8 +/- 2.4%. The vast majority (97.2%) underwent TAVI with local anaesthesia (28.8%) or conscious sedation (68.3%). Balloon predilatation was performed in 30 patients (21.6%), post-dilatation in three (2.2%). In-hospital, there were no cases of death, stroke, or conversion to open heart surgery. Major vascular complications occurred in three patients (2.2%), as well as major or life-threatening bleedings in three patients (2.2%). There were two moderate (1.4%) and no moderate/severe paravalvular leaks. Median length of stay after TAVI was three days (IQR 3-5 days). At 30 days, there were no deaths, MI, or strokes, and the incidence of new permanent pacemaker implantation was 4.4%. Conclusions: This first multicentre international experience of transfemoral TAVI with the SAPIEN 3 Ultra transcatheter heart valve shows good in-hospital and 30-day clinical outcomes.
  • Kiug, Tejs Ehlers; Hentze, Malene; Schytte, Sten; Farnebo, Lovisa; Rikardsen, Oddveig; Sihvo, Eero; Räsänen, Jari; Mäkitie, Antti (2019)
    Purpose We aimed to obtain information on the number of Nordic centers performing tracheal resections, crico-tracheal resections, and laryngo-tracheal reconstructions, as well as the patient volume and the standard regimens associated with these procedures. Methods Consultants at all Departments of Otorhinolaryngology-Head and Neck Surgery (ORL-HNS, n = 22) and Thoracic Surgery (n = 21) in the five Nordic countries were invited (April 2018-January 2019) to participate in an online survey. Results All 43 departments responded to the survey. Twenty departments declared to perform one or more of the three types of tracheal resections. At five hospitals, departments of ORL-HNS and Thoracic Surgery perform these operations in collaboration. Hence, one or more of the tracheal operations in question are carried out at 15 centers. The median annual number of tracheal operations per center is five (range 1-20). Great variations were found regarding contraindications (relative and absolute) for surgery, the use of guardian sterno-mental sutures (all patients, 33%; selected cases, 40% of centers), prophylactic antibiotic therapy (cefuroxime +/- metronidazole, penicillin +/- metronidazole, clindamycin, imipenem, or none), post-operative follow-up time (range: children: 3-120 months; adults: 0-60 months), and the performance of postoperative bronchoscopy. Conclusions Fifteen centers each perform a low number of annual operations with significant variations in the selection of patients and the clinical setup, which raises the question if a higher degree of collaboration and centralization would be warranted. We encourage Nordic transnational collaboration, pursuing alignment on central management issues, and establishment of a common prospective database for future tracheal resection surgery.
  • Malmberg, Markus; Palomäki, Antti; Sipilä, Jussi O. T.; Rautava, Päivi; Gunn, Jarmo; Kytö, Ville (2021)
    Background: Patients with rheumatoid arthritis (RA) have increased risk of developing cardiovascular disease and events. Little is, however, known about the influence of RA to the outcomes after surgical aortic valve replacement (SAVR). Methods: In a retrospective, nationwide, multicenter cohort study, RA patients (n = 109) were compared to patients without RA (n = 1090) treated with isolated SAVR for aortic valve stenosis. Propensity score-matching adjustment for baseline features was used to study the outcome differences in a median follow-up of 5.6 years. Results: Patients with RA had higher all-cause mortality (HR 1.76; CI 1.21-2.57; p = 0.003), higher incidence of major adverse cardiovascular events (HR 1.63; CI 1.06-2.49; p = 0.025), and they needed more often coronary artery revascularization for coronary artery disease (HR 3.96; CI 1.21-12.90; p = 0.027) in long-term follow-up after SAVR. As well, cardiovascular mortality rate was higher in patients with RA (35.7% vs. 23.4%, p = 0.023). There was no difference in 30-day mortality (2.8% vs. 1.8%, p = 0.518) or in the need for aortic valve reoperations (3.7% vs. 4.0%, p = 0.532). Conclusions: Patients with rheumatoid arthritis had impaired long-term results and increased cardiovascular mortality after SAVR for aortic valve stenosis. Special attention is needed to improve outcomes of aortic valve stenosis patients with RA after SAVR.
  • Nuotio, Krista; Ijäs, Petra; Heikkilä, Hanna M.; Koskinen, Suvi M.; Saksi, Jani; Vikatmaa, Pirkka; Sorto, Pia; Mäkitie, Laura; Eriksson, Henrietta; Kasari, Sonja; Silvennoinen, Heli; Valanne, Leena; Mäyränpää, Mikko I.; Kovanen, Petri T.; Soinne, Lauri; Lindsberg, Perttu J. (2018)
    Introduction: Every fifth ischemic stroke is caused by thromboembolism originating from an atherosclerotic carotid artery plaque. While prevention is the most cost-effective stroke therapy, antiplatelet and cholesterol-lowering drugs have a ceiling effect in their efficacy. Therefore, discovery of novel pathophysiologic targets are needed to improve the primary and secondary prevention of stroke. This article provides a detailed study design and protocol of HeCES2, an observational prospective cohort study with the objective to investigate the pathophysiology of carotid atherosclerosis.Materials and Methods: Recruitment and carotid endarterectomies of the study patients with carotid atherosclerosis were performed from October 2012 to September 2015. After brain and carotid artery imaging, endarterectomised carotid plaques (CPs) and blood samples were collected from 500 patients for detailed biochemical and molecular analyses.Findings to date: We developed a morphological grading for macroscopic characteristics within CPs. The dominant macroscopic CP characteristics were: smoothness 62%, ulceration 61%, intraplaque hemorrhage 60%, atheromatous gruel 59%, luminal coral-type calcification 34%, abundant (44%) and moderate (39%) intramural calcification, and symptom-causing hot spot area 53%.Future plans: By combining clinically oriented and basic biomedical research, this large-scale study attempts to untangle the pathophysiological perplexities of human carotid atherosclerosis.Key MessagesThis article is a rationale and design of the HeCES2 study that is an observational prospective cohort study with the objective to investigate the pathophysiology of carotid atherosclerosis.The HeCES2 study strives to develop diagnostic algorithms including radiologic imaging to identify carotid atherosclerosis patients who warrant surgical treatment.In addition, the study aims at finding out new tools for clinical risk stratification as well as novel molecular targets for drug development.
  • Tal, Andrea Oliver; Finkelmeier, Fabian; Filmann, Natalie; Kylänpää, Leena; Udd, Marianne; Parzanese, Ilaria; Cantu, Paolo; Dechene, Alexander; Penndorf, Volker; Schnitzbauer, Andreas; Friedrich-Rust, Mireen; Zeuzem, Stefan; Albert, Joerg G. (2017)
    Background and Aims: Treatment of anastomotic biliary strictures (ABSs) after orthotopic liver transplantation by endoscopic insertion of multiple plastic stents (MPSs) is well established. The use of covered self-expandable metal stents (cSEMSs) for this indication is less investigated. Methods: In an open-label, multicenter, randomized trial, patients with confirmed ABSs were randomly assigned 1:1 to receive either an MPS or a cSEMS. The primary endpoint was the number of endoscopic interventions until ABS resolution. Secondary endpoints were frequency of adverse events, treatment success rates, and time to treatment success and recurrence of ABS during follow-up of at least 1 year. Results: Fifty-eight patients were included between 2012 and 2015, and 48 patients completed follow-up. Patients receiving MPS (n = 24) underwent a median of 4 (range, 3-12) endoscopic retrograde cholangiography examinations, whereas those in the cSEMS group (n = 24) underwent a median of 2 (range, 2-12) sessions until ABS resolution (P <.001). A median of 8 (range, 2-32) stents was used until ABS resolution within the MPS group and 1 (range, 1-24) in the cSEMS group (P <.0001). cSEMS migration occurred in 8 (33.3%) patients. Treatment duration did not differ significantly. Initial treatment success rates were high with 23 (95.8%) in the MPS group and 24 (100%) for cSEMSs (P = 1). Five (20.8%) patients in both groups showed stricture recurrence after a median follow-up of 500 days (range, 48-1317 days). Conclusions: cSEMSs for treatment of ABSs needed less endoscopic interventions to achieve similar efficacy as MPS and might become a new treatment standard. However, the optimal duration of cSEMS therapy and cost-efficacy have to be evaluated.
  • Nissinen, Maunu; Lehto, Joonas; Biancari, Fausto; Nieminen, Tuomo; Malmberg, Markus; Yannopoulos, Fredrik; Salmi, Samuli; Airaksinen, Juhani K. E.; Kiviniemi, Tuomas; Hartikainen, Juha E. K. (2020)
    Background Preoperative permanent atrial fibrillation (AF) is associated with impaired outcome after surgical aortic valve replacement (SAVR). The impact of preoperative paroxysmal AF, however, has remained elusive. Purpose We assessed the impact of preoperative paroxysmal AF on outcome in patients undergoing SAVR with bioprosthesis. Methods A total of 666 patients undergoing isolated AVR with a bioprosthesis were included. Survival data was obtained from the national registry Statistics Finland. Patients were divided into three groups according to the preoperative rhythm: sinus rhythm (n = 502), paroxysmal AF (n = 90), and permanent AF (n = 74). Results Patients in the sinus rhythm and paroxysmal AF groups did not differ with respect to age (P = .484), gender (P = .402) or CHA(2)DS(2)-VASc score (P = .333). At 12-month follow-up, AF was present in 6.2% of sinus rhythm patients and in 42.4% of paroxysmal AF patients (P <.001). During follow-up, incidence of fatal strokes in the paroxysmal AF group was higher compared to sinus rhythm group (1.9 vs 0.4 per 100 patient-years, HR 4.4 95% Cl 1.8-11.0, P = .001). Cardiovascular mortality was higher in the paroxysmal AF group than in the sinus rhythm group (5.0 vs 3.0 per 100 patient-years, HR 1.70 95% CI 1.05-2.76, P = .03) and equal to patients in the permanent AF (5.0 per 100 patient-years). Conclusion Patients undergoing SAVR with bioprosthesis and history of paroxysmal AF had higher risk of developing permanent AF, cardiovascular mortality and incidence of fatal strokes compared to patients with preoperative sinus rhythm. Life-long anticoagulation should be considered in patients with a history of preoperative paroxysmal AF.
  • Escaned, Javier; Ryan, Nicola; Mejia-Renteria, Hernan; Cook, Christopher M.; Dehbi, Hakim-Moulay; Alegria-Barrero, Eduardo; Alghamdi, Ali; Al-Lamee, Rasha; Altman, John; Ambrosia, Alphonse; Baptista, Sergio B.; Bertilsson, Maria; Bhindi, Ravinay; Birgander, Mats; Bojara, Waldemar; Brugaletta, Salvatore; Buller, Christopher; Calais, Fredrik; Silva, Pedro Canas; Carlsson, Jorg; Christiansen, Evald H.; Danielewicz, Mikael; Di Mario, Carlo; Doh, Joon-Hyung; Erglis, Andrejs; Erlinge, David; Gerber, Robert T.; Going, Olaf; Gudmundsdottir, Ingibjorg; Haerle, Tobias; Hauer, Dario; Hellig, Farrel; Indolfi, Ciro; Jakobsen, Lars; Janssens, Luc; Jensen, Jens; Jeremias, Allen; Karegren, Amra; Karlsson, Ann-Charlotte; Kharbanda, Rajesh K.; Khashaba, Ahmed; Kikuta, Yuetsu; Krackhardt, Florian; Koo, Bon-Kwon; Koul, Sasha; Laine, Mika; Lehman, Sam J.; Lindroos, Pontus; Malik, Iqbal S.; Maeng, Michael; Matsuo, Hitoshi; Meuwissen, Martijn; Nam, Chang-Wook; Niccoli, Giampaolo; Nijjer, Sukhjinder S.; Olsson, Hans; Olsson, Sven-Erik; Omerovic, Elmir; Panayi, Georgios; Petraco, Ricardo; Piek, Jan J.; Ribichini, Flavo; Samady, Habib; Samuels, Bruce; Sandhall, Lennart; Sapontis, James; Sen, Sayan; Seto, Arnold H.; Sezer, Murat; Sharp, Andrew S. P.; Shin, Eun-Seok; Singh, Jasvindar; Takashima, Hiroaki; Talwar, Suneel; Tanaka, Nobuhiro; Tang, Kare; Van Belle, Eric; van Royen, Niels; Varenhorst, Christoph; Vinhas, Hugo; Vrints, Christiaan J.; Walters, Darren; Yokoi, Hiroyoshi; Frobert, Ole; Patel, Manesh R.; Serruys, Patrick; Davies, Justin E.; Gotberg, Matthias (2018)
    OBJECTIVES The aim of this study was to investigate the clinical outcomes of patients deferred from coronary revascularization on the basis of instantaneous wave-free ratio (iFR) or fractional flow reserve (FFR) measurements in stable angina pectoris (SAP) and acute coronary syndromes (ACS). BACKGROUND Assessment of coronary stenosis severity with pressure guidewires is recommended to determine the need for myocardial revascularization. METHODS The safety of deferral of coronary revascularization in the pooled per-protocol population (n = 4,486) of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) and iFR-SWEDEHEART (Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve in Patients With Stable Angina Pectoris or Acute Coronary Syndrome) randomized clinical trials was investigated. Patients were stratified according to revascularization decision making on the basis of iFR or FFR and to clinical presentation (SAP or ACS). The primary endpoint was major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year. RESULTS Coronary revascularization was deferred in 2,130 patients. Deferral was performed in 1,117 patients (50%) in the iFR group and 1,013 patients (45%) in the FFR group (p <0.01). At 1 year, the MACE rate in the deferred population was similar between the iFR and FFR groups (4.12% vs. 4.05%; fully adjusted hazard ratio: 1.13; 95% confidence interval: 0.72 to 1.79; p = 0.60). A clinical presentation with ACS was associated with a higher MACE rate compared with SAP in deferred patients (5.91% vs. 3.64% in ACS and SAP, respectively; fully adjusted hazard ratio: 0.61 in favor of SAP; 95% confidence interval: 0.38 to 0.99; p = 0.04). CONCLUSIONS Overall, deferral of revascularization is equally safe with both iFR and FFR, with a low MACE rate of about 4%. Lesions were more frequently deferred when iFR was used to assess physiological significance. In deferred patients presenting with ACS, the event rate was significantly increased compared with SAP at 1 year. (C) 2018 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.
  • Kim, Chee Hae; Koo, Bon-Kwon; Dehbi, Hakim-Moulay; Lee, Joo Myung; Doh, Joon-Hyung; Nam, Chang-Wook; Shin, Eun-Seok; Cook, Christopher M.; Al-Lamee, Rasha; Petraco, Ricardo; Sen, Sayan; Malik, Iqbal S.; Nijjer, Sukhjinder S.; Mejia-Renteria, Hernan; Alegria-Barrero, Eduardo; Alghamdi, Ali; Altman, John; Baptista, Sergio B.; Bhindi, Ravinay; Bojara, Waldemar; Brugaletta, Salvatore; Silva, Pedro Canas; Di Mario, Carlo; Erglis, Andrejs; Gerber, Robert T.; Going, Olaf; Haerle, Tobias; Hellig, Farrel; Indolfi, Ciro; Janssens, Luc; Jeremias, Allen; Kharbanda, Rajesh K.; Khashaba, Ahmed; Kikuta, Yuetsu; Krackhardt, Florian; Laine, Mika; Lehman, Sam J.; Matsuo, Hitoshi; Meuwissen, Martijin; Niccoli, Giampaolo; Piek, Jan J.; Ribichini, Flavo; Samady, Habib; Sapontis, James; Seto, Arnold H.; Sezer, Murat; Sharp, Andrew S. P.; Singh, Jasvindar; Takashima, Hiroaki; Talwar, Suneel; Tanaka, Nobuhiro; Tang, Kare; Van Belle, Eric; van Royen, Niels; Vinhas, Hugo; Vrints, Christiaan J.; Walters, Darren; Yokoi, Hiroyoshi; Samuels, Bruce; Buller, Christopher; Patel, Manesh R.; Serruys, Patrick W.; Escaned, Javier; Davies, Justin E. (2019)
    OBJECTIVES This study sought to evaluate sex differences in procedural characteristics and clinical outcomes of instantaneous wave-free ratio (iFR)- and fractional flow reserve (FFR)-guided revascularization strategies. BACKGROUND An iFR-guided strategy has shown a lower revascularization rate than an FFR-guided strategy, without differences in clinical outcomes. METHODS This is a post hoc analysis of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate stenosis to guide Revascularization) study, in which 601 women and 1,891 men were randomized to iFR- or FFR-guided strategy. The primary endpoint was 1-year major adverse cardiac events (MACE), a composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization. RESULTS Among the entire population, women had a lower number of functionally significant lesions per patient (0.31 +/- 0.51 vs. 0.43 +/- 0.59; p <0.001) and less frequently underwent revascularization than men (42.1% vs. 53.1%; p <0.001). There was no difference in mean iFR value according to sex (0.91 +/- 0.09 vs. 0.91 +/- 0.10; p = 0.442). However, the mean FFR value was lower in men than in women (0.83 +/- 0.09 vs. 0.85 +/- 0.10; p = 0.001). In men, an FFR-guided strategy was associated with a higher rate of revascularization than an iFR-guided strategy (57.1% vs. 49.3%; p = 0.001), but this difference was not observed in women (41.4% vs. 42.6%; p = 0.757). There was no difference in MACE rates between iFR- and FFR-guided strategies in both women (5.4% vs. 5.6%, adjusted hazard ratio: 1.10; 95% confidence interval: 0.50 to 2.43; p = 0.805) and men (6.6% vs. 7.0%, adjusted hazard ratio: 0.98; 95% confidence interval: 0.66 to 1.46; p = 0.919). CONCLUSIONS An FFR-guided strategy was associated with a higher rate of revascularization than iFR-guided strategy in men, but not in women. However, iFR- and FFR-guided strategies showed comparable clinical outcomes, regardless of sex. (C) 2019 by the American College of Cardiology Foundation.
  • Jaakkola, Jussi; Jaakkola, Samuli; Airaksinen, K. E. Juhani; Husso, Annastiina; Juvonen, Tatu; Laine, Mika; Virtanen, Marko; Maaranen, Pasi; Niemelä, Matti; Mäkikallio, Timo; Savontaus, Mikko; Tauriainen, Tuomas; Valtola, Antti; Vento, Antti; Eskola, Markku; Raivio, Peter; Biancari, Fausto (2020)
    Whether the subtype of atrial fibrillation affects outcomes after transcatheter aortic valve replacement for aortic stenosis is unclear. The nationwide FinnValve registry included 2130 patients who underwent primary after transcatheter aortic valve replacement for aortic stenosis during 2008–2017. Altogether, 281 (13.2%) patients had pre-existing paroxysmal atrial fibrillation, 651 (30.6%) had pre-existing non-paroxysmal atrial fibrillation and 160 (7.5%) were diagnosed with new-onset atrial fibrillation during the index hospitalization. The median follow-up was 2.4 (interquartile range: 1.6–3.8) years. Paroxysmal atrial fibrillation did not affect 30-day or overall mortality (p-values >0.05). Non-paroxysmal atrial fibrillation demonstrated an increased risk of overall mortality (hazard ratio: 1.61, 95% confidence interval: 1.35–1.92; p0.05). In conclusion, non-paroxysmal atrial fibrillation and new-onset atrial fibrillation are associated with increased mortality after transcatheter aortic valve replacement for aortic stenosis, whereas paroxysmal atrial fibrillation has no effect on mortality. These findings suggest that non-paroxysmal atrial fibrillation rather than paroxysmal atrial fibrillation may be associated with structural cardiac damage which is of prognostic significance in patients with aortic stenosis undergoing transcatheter aortic valve replacement.
  • Mäkikallio, Timo; Jalava, Maina P.; Husso, Annastiina; Virtanen, Marko; Laakso, Teemu; Ahvenvaara, Tuomas; Tauriainen, Tuomas; Maaranen, Pasi; Kinnunen, Eeva-Maija; Dahlbacka, Sebastian; Jaakkola, Jussi; Airaksinen, Juhani; Anttila, Vesa; Savontaus, Mikko; Laine, Mika; Juvonen, Tatu; Valtola, Antti; Raivio, Peter; Eskola, Markku; Niemelä, Matti; Biancari, Fausto (2019)
    Aim: We investigated the outcomes of transcatheter (TAVR) and surgical aortic valve replacement (SAVR) in Finland during the last decade. Methods: The nationwide FinnValve registry included data from 6463 patients who underwent TAVR or SAVR with a bioprosthesis for aortic stenosis from 2008 to 2017. Results: The annual number of treated patients increased three-fold during the study period. Thirty-day mortality declined from 4.8% to 1.2% for TAVR (p = .011) and from 4.1% to 1.8% for SAVR (p = .048). Two-year survival improved from 71.4% to 83.9% for TAVR (p <.001) and from 87.2% to 91.6% for SAVR (p = .006). During the study period, a significant reduction in moderate-to-severe paravalvular regurgitation was observed among TAVR patients and a reduction of the rate of acute kidney injury was observed among both SAVR and TAVR patients. Similarly, the rate of red blood cell transfusion and severe bleeding decreased significantly among SAVR and TAVR patients. Hospital stay declined from 10.4 +/- 8.4 to 3.7 +/- 3.4 days after TAVR (p <.001) and from 9.0 +/- 5.9 to 7.8 +/- 5.1 days after SAVR (p <.001). Conclusions: In Finland, the introduction of TAVR has led to an increase in the invasive treatment of severe aortic stenosis, which was accompanied by improved early outcomes after both SAVR and TAVR.
  • Bapat, Vinayak; Frank, Derk; Cocchieri, Ricardo; Jagielak, Dariusz; Bonaros, Nikolaos; Aiello, Marco; Lapeze, Joel; Laine, Mika; Chocron, Sidney; Muir, Douglas; Eichinger, Walter; Thielmann, Matthias; Labrousse, Louis; Rein, Kjell Arne; Verhoye, Jean-Philippe; Gerosa, Gino; Baumbach, Hardy; Bramlage, Peter; Deutsch, Cornelia; Thoenes, Martin; Romano, Mauro (2016)
    OBJECTIVES The Registry of the Utilization of the TAo-TAVR approach using the Edwards SAPIEN Valve (ROUTE) was established to assess the effectiveness and safety of the use of transaortic (TAo) access for transcatheter aortic valve replacement (TAVR) procedures (NCT01991431). BACKGROUND TAVR represents an alternative to surgical valve replacement in high-risk patients. Whereas the transfemoral access route is used commonly as the first-line approach, transapical access is an option for patients not suitable for transfemoral treatment mainly due to anatomic conditions. TAo-TAVR has been shown to be a viable alternative surgical access route; however, only limited data on its effectiveness and safety has been published. METHODS ROUTE is a multicenter, international, prospective, observational registry; data were collected from 18 centers across Europe starting in February 2013. Patients having severe calcific aortic stenosis were documented if they were scheduled to undergo TAo-TAVR using an Edwards SAPIEN XT or a SAPIEN 3 valve. The primary endpoint was 30-day mortality. Secondary endpoints were intraprocedural or in hospital and 30-day complication rates. RESULTS A total of 301 patients with a mean age of 81.7 +/- 5.9 years and an Society of Thoracic Surgeons score of 9.0 +/- 7.6% were included. Valve success was documented in 96.7%. The 30-day mortality was 6.1% (18/293) (procedure-related mortality: 3.1%; 9 of 293). The Valve Academic Research Consortium-2 defined complications included myocardial infarction (1.0%), stroke (1.0%), transient ischemic attack (0.3%), major vascular complications (3.4%), life-threatening bleeding (3.4%), and acute kidney injury (9.5%). In 3.3% of patients, paravalvular regurgitation was classified as moderate or severe (10 of 300). Twenty-six patients (8.8%) required permanent pacemaker implantation. CONCLUSIONS TAo access for TAVR seems to be a safe alternative to the transapical procedure. (C) 2016 by the American College of Cardiology Foundation.