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INTRODUCTION: Cardiac surgery in patients on chronic renal dialysis is associated with significant morbidity and mortality. Minimally invasive extracorporeal circuits (MiECC) have shown a positive impact on patient outcome in different high-risk populations. This retrospective study compares the outcome of these high-risk patients undergoing heart surgery either with a MiECC or a conventional extracorporeal circulation (CECC). METHODS: This is a single-center experience including 131 consecutive dialysis dependent patients undergoing cardiac surgery between January 2006 and December 2016. A propensity score matching was employed leaving 30 matched cases in each group. RESULTS: After propensity score matching the 30-day mortality was significantly lower in the MiECC group (n = 3 (10%) vs n = 10 (33%) in the CECC group, p = .028). Further, intraoperative transfused units of packed red blood cells were lower in the MiECC group (1.4 ± 1.8 units vs 2.8 ± 1.7, p < .001). CONCLUSIONS: There are evident advantages to using MiECC in dialysis dependent patients, especially regarding mortality. These findings necessitate additional research in MiECC usage in high-risk populations.
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BACKGROUND: Previous studies have demonstrated the efficacy of rehabilitation after a cardiovascular procedure. Especially older and multimorbid patients benefit from rehabilitation after a cardiac procedure. Prehabilitation prior to cardiac procedures may also have positive effects on patients' pre- and postoperative outcomes. Results of a current meta-analysis show that prehabilitation prior to cardiac procedures can improve perioperative outcomes and alleviate adverse effects. Germany currently lacks a structured cardiac prehabilitation program for older patients, which is coordinated across healthcare sectors. METHODS: In a randomized, controlled, two-arm parallel group, assessor-blinded multicenter intervention trial (PRECOVERY), we will randomize 422 patients aged 75 years or older scheduled for an elective cardiac procedure (e.g., coronary artery bypass graft surgery or transcatheter aortic valve replacement). In PRECOVERY, patients randomized to the intervention group participate in a 2-week multimodal prehabilitation intervention conducted in selected cardiac-specific rehabilitation facilities. The multimodal prehabilitation includes seven modules: exercise therapy, occupational therapy, cognitive training, psychosocial intervention, disease-specific education, education with relatives, and nutritional intervention. Participants in the control group receive standard medical care. The co-primary outcomes are quality of life (QoL) and mortality after 12 months. QoL will be measured by the EuroQol 5-dimensional questionnaire (EQ-5D-5L). A health economic evaluation using health insurance data will measure cost-effectiveness. A mixed-methods process evaluation will accompany the randomized, controlled trial to evaluate dose, reach, fidelity and adaptions of the intervention. DISCUSSION: In this study, we investigate whether a tailored prehabilitation program can improve long-term survival, QoL and functional capacity. Additionally, we will analyze whether the intervention is cost-effective. This is the largest cardiac prehabilitation trial targeting the wide implementation of a new form of care for geriatric cardiac patients. TRIAL REGISTRATION: German Clinical Trials Register (DRKS; http://www.drks.de ; DRKS00030526). Registered on 30 January 2023.
Subject(s)
Cardiac Rehabilitation , Quality of Life , Humans , Aged , Preoperative Exercise , Coronary Artery Bypass , Cardiac Rehabilitation/adverse effects , Exercise Therapy/adverse effects , Randomized Controlled Trials as Topic , Multicenter Studies as Topic , Meta-Analysis as TopicABSTRACT
BACKGROUND AND OBJECTIVES: Corrected count increment (CCI) measurements monitor the effectiveness of platelet transfusions in haemato-oncology, but they usually fail in patients undergoing cardiac surgery. We investigated whether polymerase chain reaction (PCR) of mitochondrial single-nucleotide polymorphisms (SNPs) is able to monitor the survival of transfused platelets in these patients. MATERIALS AND METHODS: Leukocyte-free, platelet-rich plasma was prepared from patients' blood to measure platelet counts based on patient-/donor-specific SNPs by digital PCR after DNA extraction. Platelet counts in samples from patients with severe thrombocytopenia were analysed by both PCR and flow cytometry. Ten patients undergoing cardiac surgery with the use of heart lung machine and without overt bleeding received a single apheresis platelet concentrate because of either dual platelet inhibition during a non-elective intervention or a complex procedure. Blood samples were collected at nine defined intervals (0-120 h) post transfusion. RESULTS: The digital PCR of the seven SNPs reliably quantified levels ≥0.6 G/L platelets, in good agreement with flow cytometry and without interference by other SNPs or by platelet activation. A mean 24-h CCI of 11.8 (range: 5.6-19.8) and a mean 120-h area under the curve (AUC) of 1386 (915-1821) hxG/L were observed for the transfused platelets. The mean AUC of 14,103 (3415-27,305) hxG/L for the patients' endogenous platelets indicates that transfused platelets represented only 11% (5-25) of the total platelet counts during 120 h post transfusion. CONCLUSION: PCR of mitochondrial SNPs offers a tool to assess the survival of platelets from apheresis concentrates in cardiac surgery patients to facilitate the implementation of improved transfusion strategies.
Subject(s)
Cardiac Surgical Procedures , Thrombocytopenia , Humans , Platelet Transfusion/methods , Blood Platelets/physiology , Polymerase Chain ReactionABSTRACT
OBJECTIVES: The aim of this retrospective study was to assess the early- and long-term outcomes following the use of cryopreserved allografts in aortic valve endocarditis with peri-annular abscess formation. METHODS: From 2001 to 2021, 110 consecutive patients with active infective endocarditis and peri-annular abscess, underwent a cryopreserved allograft root replacement. In 100 patients (91%), the operation was performed <48 h after admission due to refractory heart failure and or septic shock. In 95 patients (86.4%), a redo operation was performed due to a prosthetic valve endocarditis. Preoperatively, 12 patients were dialysis-dependent and 30 patients suffered from a recent stroke. RESULTS: The 30-day mortality was 18% (20 patients). Freedom from reintervention was 98.3% (standard deviation: 1.7) at 1 year and 83.3% (standard deviation: 8.5) at 10 years. Four patients required a redo operation. Three patients did develop re-endocarditis. Freedom from re-endocarditis was 95% after 17 years of follow-up. Preoperative dialysis dependency (odds ratio: 22.75, 95% confidence interval: 4.79-108.14, P < 0.001), ejection fraction under 30% (odds ratio: 17.91, 95% confidence interval: 3.27-98.01, P < 0.001) and stroke within 14 days prior to operation (odds ratio: 5.21, 95% confidence interval: 1.28-21.2, P = 0.021) were incremental factors associated with the 30-day mortality. CONCLUSIONS: In aortic root endocarditis with abscesses formation, cryopreserved allografts exhibit excellent clinical performance with a low rate of reinfection and reintervention, which make its use as valve replacement a very desirable option. Dialysis dependency, ejection fraction under 30% and recent stroke have the highest impact on the 30-day mortality.
Subject(s)
Endocarditis, Bacterial , Endocarditis , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Stroke , Abscess/etiology , Abscess/surgery , Allografts/surgery , Aortic Valve/surgery , Aortic Valve/transplantation , Endocarditis/surgery , Endocarditis, Bacterial/surgery , Heart Valve Prosthesis Implantation/adverse effects , Humans , Reoperation , Retrospective StudiesABSTRACT
OBJECTIVE: Minimal invasive extracorporeal circuits (MiECC) have been associated with a significant reduction in the incidence of postoperative atrial fibrillation (AF). Nevertheless, AF remains one of the most common complications following elective primary coronary artery bypass grafting (CABG). The aim of this study was to identify the predictors of AF persisting beyond the hospital stay in elective primary CABG patients. METHODS: We conducted a retrospective analysis for the predictors of AF that persisted beyond discharge between all patients who received an elective isolated CABG in our institution between 2009 and 2014. Patients with a positive history for intermittent or persistent AF were excluded from the analysis. Almost all patients were discharged to a rehabilitation facility where they stayed for 3 to 4 weeks postoperatively. At rehab approximately 91% of them received Holter monitoring at least once prior to their discharge. RESULTS: A total of 770 patients were included in the analysis of which 763 patients survived the in-hospital stay. The incidence of AF at hospital discharge was 4.2% (32/763) while that on Holter monitor at Rehab was 1.5% (10/685). Age and the type of extracorporeal circuit (ECC) utilized were the only significant predictors for both AF at discharge (p < 0.01 both) and on Holter monitor in rehab (p < 0.01 and 0.02, respectively). This was also confirmed on multivariate analysis. CONCLUSION: Our findings show that the benefits of MiECC regarding the incidence of postoperative AF persist beyond hospital discharge. They may thus positively influence the outcomes of patients beyond the early postoperative period.
Subject(s)
Atrial Fibrillation , Patient Discharge , Atrial Fibrillation/etiology , Coronary Artery Bypass/adverse effects , Hospitals , Humans , Postoperative Complications/etiology , Postoperative Period , Retrospective StudiesABSTRACT
OBJECTIVES: The aim of this study was to compare outcomes of transcatheter and surgical aortic valve implantation in chronic dialysis patients with aortic valve stenosis (AS). BACKGROUND: Chronic dialysis patients undergoing heart valve surgery are at higher risk for morbidity and mortality. Whether interventional techniques can reduce this risk is unclear because dialysis patients have thus far been excluded from randomized trials. METHODS: Chronic dialysis patients with AS enrolled in the German Aortic Valve Registry (GARY) between 2012 and 2015 were analyzed to compare transcatheter aortic valve implantation (TAVI n = 661) with surgical aortic valve replacement (SAVR n = 457). Propensity scores for inverse probability of treatment weighting (IPTW) were used to adjust the comparison of the two treatment groups for potential confounders. RESULTS: TAVI patients were older (78 ± 7.3 vs. 69 ± 10.2 years, p < 0.01, unadjusted) and had more comorbidities. Mortality at 1 year was the same (TAVI: 33.4% vs. SAVR 35.0%, p = 0.72, IPTW-adjusted) while it was lower with TAVI at 30 days (8.6% vs. 15.0%, p = 0.02, IPTW-adjusted). TAVI patients required more pacemaker implantation and showed more aortic regurgitation. SAVR patients required more blood transfusions and had longer hospital stay. Diabetes mellitus, atrial fibrillation, previous PCI, urgent procedure and EuroSCORE were associated with elevated 30-day mortality. Atrial fibrillation and older age were independent risk factor of 1-year mortality in both groups. CONCLUSIONS: Chronic dialysis patients with AS undergoing TAVI or SAVR had the same 1-year mortality, although survival at 30 days was better with TAVI. These results suggest that TAVI may improve peri-procedural outcomes.
Subject(s)
Aortic Valve Stenosis/surgery , Heart Valve Prosthesis , Kidney Failure, Chronic/therapy , Propensity Score , Registries , Renal Dialysis/methods , Transcatheter Aortic Valve Replacement/methods , Aged , Aortic Valve/surgery , Aortic Valve Stenosis/epidemiology , Comorbidity , Female , Follow-Up Studies , Germany/epidemiology , Humans , Kidney Failure, Chronic/epidemiology , Male , Prospective Studies , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVES: Minimally invasive extracorporeal circuits have been introduced to cardiac surgery in an attempt to reduce the negative effects of cardiopulmonary bypass on patient outcome. On the other hand, transcatheter aortic valve replacement (TAVR) provides an excellent option to replace the aortic valve without the need for cardiopulmonary bypass. Several studies have compared TAVR to surgical aortic valve replacement (SAVR) but none have utilized a minimally invasive extracorporeal circuit. METHODS: We retrospectively analysed the results of both procedures among octogenarians operated in our department from 2003 to 2016. Excluded were patients with an active endocarditis, a history of previous cardiac surgery, as well as those who had a minimally invasive surgical approach. This yielded 81 and 142 octogenarians in the SAVR and TAVR groups, respectively. To compensate for a lack of randomization, we performed a propensity score analysis, which yielded 68 patient pairs for the final analysis. RESULTS: The 30-day postoperative mortality was lower in the SAVR group (1.5% vs 5.9%) but not statistically significant (P = 0.4). In contrast, the incidence of postoperative atrial fibrillation was lower in the TAVR group (13% vs 29%) but also non-significant (P = 0.2). Finally, the incidence of paravalvular leakage was in favour of the SAVR group (2.9% vs 52%; P = 0.001) while the transfusion requirement was significantly lower in the TAVR group (29% vs 72%; P < 0.001). CONCLUSIONS: SAVR utilizing a minimally invasive extracorporeal circuit improves the quality of patient care and can offer an alternative to TAVR in octogenarians.
Subject(s)
Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Extracorporeal Membrane Oxygenation/methods , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis , Minimally Invasive Surgical Procedures/methods , Postoperative Complications/epidemiology , Age Factors , Aged, 80 and over , Female , Germany/epidemiology , Humans , Incidence , Male , Propensity Score , Retrospective Studies , Survival Rate/trends , Treatment OutcomeABSTRACT
OBJECTIVES: The purpose of this study was to evaluate the incidence of new pacemaker implantation (NPMI) after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR), and investigate its influence on 1-year mortality. METHODS: Patients who were enrolled in 'The German Aortic Valve Registry' undergoing isolated TAVR or SAVR between 2011 and 2015 were analysed. The rate of NPMI was analysed for both groups and multivariable Cox regression analysis was performed to investigate the possible independent association between NPMI and 1-year mortality. RESULTS: Twenty thousand eight hundred and seventy-two patients who underwent TAVR and 17 750 patients who received SAVR were included in this study. The rate of NPMI was 16.6% after TAVR and 3.6% after SAVR. In the TAVR group, NPMI was associated with significantly increased 1-year mortality in univariable Cox regression analysis [hazard ratio (HR) 1.29, confidence interval (CI) 1.18-1.41; P < 0.001]. This association persisted after adjustment for confounding factors (HR 1.29, CI 1.16-1.43; P < 0.001). In the SAVR group, NPMI significantly increased 1-year mortality in univariable analysis as well (HR 1.55, CI 1.08-2.22; P = 0.02), whereas after multivariable adjustment, NPMI did not emerge as an independent risk factor (HR 1.29, 0.88-1.89; P = 0.19). NPMI was not associated with 30-day mortality in both procedure groups. CONCLUSIONS: The rate of NPMI was markedly higher after TAVR compared with SAVR and was independently associated with 1-year mortality after TAVR, whereas this was not significant after SAVR. As 30-day mortality was not different for TAVR and SAVR, the subsequent procedure of an NPMI itself seems not to increase the risk of mortality.
Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis Implantation , Pacemaker, Artificial , Transcatheter Aortic Valve Replacement , Aortic Valve/surgery , Aortic Valve Stenosis/surgery , Humans , Risk Factors , Transcatheter Aortic Valve Replacement/adverse effects , Treatment OutcomeABSTRACT
Based on a longtime voluntary registry, founded by the German Society for Thoracic and Cardiovascular Surgery (GSTCVS), well-defined data of all cardiac, thoracic, and vascular surgery procedures performed in 78 German heart surgery departments during the year 2018 are analyzed. For this period, a total of 174,902 procedures were submitted to the registry, 98,707 summarized as heart surgery procedures in the classical meaning. The unadjusted in-hospital survival rate for 33,999 isolated coronary artery bypass grafting procedures (relationship on-/off-pump 3.8:1) was 97.1% and for 34,915 isolated heart valve procedures, 14,396 transcatheter interventions included, it was 96.0%. Concerning short- and long-term circulatory supports, a total of 2,871 extracorporeal life support (ECLS)/extracorporeal membrane oxygenation (ECMO) implants, respectively, 942 assist device implantations (L-/R-/BVAD, TAH) were registered. In 2018, the number of isolated heart transplantations increased to 312, a growth of 23% compared with the previous year. The isolated lung transplantations reached 340, a rise of nearly 19%. This annual updated registry of the GSTCVS represents voluntary public reporting by accumulating actual information for nearly all heart surgical procedures in Germany, constitutes advancements in heart medicine, and is a basis for quality management for all participating institutions. In addition, the registry demonstrates that the provision of cardiac surgery in Germany is appropriate and nationwide patient treatment is guaranteed all the time.
Subject(s)
Cardiac Surgical Procedures/trends , Heart Diseases/surgery , Cardiac Surgical Procedures/adverse effects , Cardiac Surgical Procedures/instrumentation , Cardiac Surgical Procedures/mortality , Germany/epidemiology , Heart Diseases/diagnosis , Heart Diseases/mortality , Hospital Mortality/trends , Humans , Postoperative Complications/mortality , Practice Patterns, Physicians'/trends , Quality Indicators, Health Care/trends , Registries , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVE: The positive impact of minimally invasive extracorporeal circuits (MiECC) on patient outcome is expected to be most evident in patients with limited physiologic reserves. Nevertheless, most studies have limited their use to low-risk patients undergoing myocardial revascularization. As such, there is little evidence to their benefit outside this patient population. We, therefore, set out to explore their potential benefit in octogenarians undergoing aortic valve replacement (AVR) with or without concomitant myocardial revascularization. METHODS: Based on the type of the utilized ECC, we performed a retrospective propensity score-matched comparison among all octogenarians (n = 218) who received a primary AVR with or without concomitant coronary artery bypass grafting in our institution between 2003 and 2010. RESULTS: A MiECC was utilized in 32% of the patients. The propensity score matching yielded 52 matched pairs. The 30-day postoperative mortality (2% vs. 10%; p=0.2), the incidence of low cardiac output (0% vs. 6%; p=0.2) and the Intensive Care Unit (ICU) stay (2.5 ± 2.6 vs. 3.8 ± 4.7 days; p=0.06) were all in favour of the MiECC group, but failed to reach statistical significance while the 90-day postoperative mortality did (2% vs. 16%; p=0.02). CONCLUSION: MiECCs have a positive influence on the outcome of octogenarians undergoing AVR with or without concomitant coronary artery bypass grafting. Their use should, therefore, be extended beyond isolated coronary artery bypass graft (CABG) surgery.
Subject(s)
Aortic Valve/surgery , Heart Valve Prosthesis Implantation , Myocardial Revascularization , Aged , Aged, 80 and over , Coronary Artery Bypass/instrumentation , Coronary Artery Bypass/methods , Equipment Design , Female , Heart Valve Prosthesis , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis Implantation/methods , Humans , Male , Minimally Invasive Surgical Procedures/instrumentation , Minimally Invasive Surgical Procedures/methods , Myocardial Revascularization/instrumentation , Myocardial Revascularization/methods , Propensity Score , Retrospective Studies , Treatment OutcomeABSTRACT
BACKGROUND: In context of the multidisciplinary German scientific guideline "Use of extracorporeal circulation (extracorporeal life support [ECLS]/extracorporeal membrane oxygenation) for cardiac and circulatory failure," a nationwide survey should depict the status of organization and application of ECLS therapy in Germany. METHODS: Between June and October 2017, a standardized questionnaire consisting of 30 items related to ECLS therapy was sent to all German cardiosurgical departments, and all returned results were analyzed and evaluated. RESULTS: The return rate amounted to 92.9% (78 out of 84 departments). In the participating departments, ECLS therapy is subject to different responsibilities, and exhibits divergent processes and various ways for specialization of the involved personnel. This also concerns local application standards, such as cannulation strategies, anticoagulation management, left ventricular unloading, antiwatershed treatment, and weaning from circulatory support. CONCLUSION: This nationwide survey underlines the necessity of a multidisciplinary guideline concerning ECLS therapy.
Subject(s)
Cardiology Service, Hospital/organization & administration , Delivery of Health Care/organization & administration , Extracorporeal Membrane Oxygenation , Heart Failure/therapy , Shock/therapy , Cardiology Service, Hospital/trends , Delivery of Health Care/trends , Extracorporeal Membrane Oxygenation/adverse effects , Extracorporeal Membrane Oxygenation/trends , Germany , Health Care Surveys , Heart Failure/diagnosis , Heart Failure/physiopathology , Humans , Patient Care Team/organization & administration , Recovery of Function , Shock/diagnosis , Shock/physiopathology , Treatment OutcomeABSTRACT
Based on a longtime voluntary registry, founded by the German Society for Thoracic and Cardiovascular Surgery (GSTCVS), well-defined data of all cardiac, thoracic, and vascular surgery procedures performed in 78 German heart surgery departments during the year 2017 are analyzed. In 2017, a total of 179,337 procedures were submitted to the registry, and 101,728 were summarized as heart surgery procedures in the narrower sense. About 16.8% of these patients were at least 80 years old, resulting in an increase of 1.1% compared with the data of 2016. The 36,273 isolated coronary artery bypass grafting procedures (relationship on-/off-pump 4.2:1) were associated with an unadjusted in-hospital survival rate of 97.3%. Concerning the 34,394 isolated heart valve procedures (including 12,965 transcatheter interventions), the unadjusted in-hospital survival rate was 96.0%.This annual updated registry of the GSTCVS represents voluntary public reporting by accumulating actual information for nearly all heart surgical procedures in Germany, describes advancements in heart medicine, and is a basis for in- and external quality assurance for all participating institutions. In addition, the registry demonstrates that the provision of cardiac surgery in Germany is appropriate, and nationwide patient treatment is guaranteed at any time.
Subject(s)
Cardiac Surgical Procedures/trends , Heart Diseases/surgery , Cardiac Surgical Procedures/adverse effects , Cardiac Surgical Procedures/mortality , Germany/epidemiology , Health Services Needs and Demand/trends , Heart Diseases/diagnosis , Heart Diseases/epidemiology , Humans , Quality Indicators, Health Care/trends , Registries , Risk Factors , Societies, Medical , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: Transcatheter aortic valve replacement (TAVR) is increasingly being used for treatment of severe aortic valve stenosis in patients at intermediate risk for surgical aortic valve replacement (SAVR). Currently, real-world data comparing indications and clinical outcomes of patients at intermediate surgical risk undergoing isolated TAVR with those undergoing SAVR are scarce. METHODS: We compared clinical characteristics and outcomes of patients with intermediate surgical risk (Society of Thoracic Surgeons score 4%-8%) who underwent isolated TAVR or conventional SAVR within the prospective, all-comers German Aortic Valve Registry. RESULTS: A total of 7613 patients at intermediate surgical risk underwent isolated TAVR (n=6469) or SAVR (n=1144) at 92 sites in Germany between 2012 and 2014. Patients treated by TAVR were significantly older (82.5±5.0 versus 76.6±6.7 years, P<0.001) and had higher risk scores (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation]: 21.2±12.3% versus 14.2±9.5%, P<0.001; Society of Thoracic Surgeons score: 5.6±1.1 versus 5.2±1.0, P<0.001). Multivariable analyses revealed that advanced age, coronary artery disease, New York Heart Association class III/IV, pulmonary hypertension, prior cardiac decompensation, elective procedure, arterial occlusive disease, no diabetes mellitus, and a smaller aortic valve area were associated with performing TAVR instead of SAVR (all P<0.001). Unadjusted in-hospital mortality rates were equal for TAVR and SAVR (3.6% versus 3.6%, P=0.976), whereas unadjusted 1-year mortality was significantly higher in patients after TAVR (17.5% versus 10.8%, P<0.001). After propensity score matching, the difference in 1-year mortality between patients with TAVR and SAVR was no longer significant (17.1% versus 15.7%, P=0.59). CONCLUSIONS: Patients at intermediate risk undergoing TAVR differ significantly from those treated with SAVR with regard to age and baseline characteristics. Isolated TAVR and SAVR were associated with an in-hospital mortality rate of 3.6%. In the propensity score analysis, there was no significant difference in 1-year mortality between patients with TAVR and SAVR.
Subject(s)
Aortic Valve Stenosis/surgery , Heart Valve Prosthesis Implantation , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Aortic Valve Stenosis/mortality , Female , Follow-Up Studies , Germany , Hospital Mortality , Humans , Kaplan-Meier Estimate , Male , Propensity Score , Registries , Risk Factors , Treatment OutcomeABSTRACT
BACKGROUND: Surgical aortic valve replacement using conventional biological valves (CBVs) is the standard of care for treatment of old patients with aortic valve disease. Recently, rapid deployment valves (RDVs) have been introduced. OBJECTIVES: The purpose of this study was to report the nationwide German experience concerning RDVs for treatment of aortic valve stenosis and provide a head-to-head comparison with CBVs. METHODS: A total of 22,062 patients who underwent isolated surgical aortic valve replacement using CBV or RDV between 2011 and 2015 were enrolled into the German Aortic Valve Registry. Baseline, procedural, and in-hospital outcome parameters were analyzed for CBVs and RDVs using 1:1 propensity score matching. Furthermore, 3 RDVs were compared with each other. RESULTS: A total of 20,937 patients received a CBV, whereas 1,125 patients were treated with an RDV. Patients treated with an RDV presented with significantly reduced procedure (160 min [25th to 75th percentile: 135 to 195 min] vs. 150 min [25th to 75th percentile: 127 to 179 min]; p < 0.001), cardiopulmonary bypass (83 min [25th to 75th percentile: 68 to 104 min] vs. 70 min [25th to 75th percentile: 56 to 87 min]; p < 0.001), and aortic cross clamp times (60 min [25th to 75th percentile: 48 to 75 min] vs. 44 min [25th to 75th percentile: 35 to 57 min]; p < 0.001), but showed significantly elevated rates of pacemaker implantation (3.7% vs. 8.8%; p < 0.001) and disabling stroke (0.9% vs. 2.2%; p < 0.001), whereas in-hospital mortality was similar (1.7% vs. 2.2%; p = 0.22). These findings persisted after 1:1 propensity score matching. Comparison of the 3 RDVs revealed statistically nonsignificant different pacemaker rates and significantly different post-operative transvalvular gradients. CONCLUSIONS: In this large, all-comers database, the incidence of pacemaker implantation and disabling stroke was higher with RDVs, whereas no beneficial effect on in-hospital mortality was seen. The 3 RDVs presented different complication profiles with regard to pacemaker implantation and transvalvular gradients. (German Aortic Valve Registry [GARY]; NCT01165827).
Subject(s)
Aortic Valve Stenosis/epidemiology , Aortic Valve Stenosis/surgery , Bioprosthesis , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis , Prosthesis Design/instrumentation , Aged , Aortic Valve Stenosis/diagnostic imaging , Female , Germany/epidemiology , Heart Valve Prosthesis Implantation/methods , Humans , Male , Prospective Studies , Prosthesis Design/methods , Registries , Time FactorsABSTRACT
BACKGROUND: We present our results after elective, isolated David I procedures over the past 20 years. METHODS: Between 1993 and 2015, 197 patients (mean age 46 ± 17 years, 73% men) underwent isolated aortic valve reimplantation using straight tube grafts (David I procedure). Sixty patients (31%) had Marfan syndrome, and 24 (12%) had a bicuspid aortic valve. Twenty-four patients (12%) were operated through upper mini-sternotomy. RESULTS: There were no perioperative deaths. Stroke rate was 1% (2 of 197). Discharge echocardiography showed none to trivial aortic regurgitation (AR) in 71% (139 of 197 patients) and mild AR in 26% (51 of 197 patients). Thirty-two patients (16%) died during follow-up (9.0 ± 5.5 years after operation). One death was aortic valve related. Twenty-six patients (13%) underwent aortic valve reoperations during follow-up (5.5 ± 5.0 years after operation). Late endocarditis occurred in 2 patients (1.0%). More than trivial AR at discharge predicted a higher reoperation rate. In 144 non-reoperated survivors, echocardiography showed none to trivial AR in 56 (39%), mild AR in 53 (37%), moderate AR in 19 (6.3%), and severe AR in 4 (2.7%) of the patients after 12 ± 5.3 years. CONCLUSIONS: The valve-sparing David I procedure has excellent short- and long-term results. Erosion due to supposed leaflet contact with the straight tube graft was not observed in any patient, proving that using a straight graft has no negative impact on the leaflets. The "spared valve" (being native living tissue) seems to be more resistant to infection than prosthetic valves.
Subject(s)
Aortic Valve/abnormalities , Blood Vessel Prosthesis Implantation/methods , Heart Valve Diseases/surgery , Heart Valve Prosthesis , Marfan Syndrome/surgery , Adult , Aged , Aortic Valve/surgery , Bicuspid Aortic Valve Disease , Elective Surgical Procedures , Female , Humans , Male , Middle Aged , Reoperation , Retrospective Studies , Treatment OutcomeABSTRACT
OBJECTIVES: Surgical aortic valve replacement (sAVR) is coming under close scrutiny with the recent upswing in the use of less invasive approaches. The aim of this analysis was to identify current trends in patient selection, procedural characteristics and outcomes after sAVR in Germany. METHODS: We analysed data from 42 776 patients included in the German Aortic Valve Registry who underwent sAVR with and without coronary artery bypass surgery (CABG) between 2011 and 2015. Baseline, procedural and short-term outcome parameters were analysed. RESULTS: Of all registered patients, 26 618 (62.2%) underwent isolated sAVR and 16 158 (37.8%) sAVR + CABG. The median age was 72 years, and the median Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) was 2.3%. From 2011 to 2015, there was a decline in STS PROM (2.4-2.2%, P < 0.001) and a decline in risk factors, such as pulmonary hypertension (9.1-3.2%, P < 0.001), occlusive arterial disease (19.6-17.7%, P = 0.003), mitral regurgitation ≥2° (10.6-7.6%, P < 0.001) and New York Heart Association Class III/IV (65.3-59.2%, P < 0.001). In-hospital mortality was 2.3%, 1.3% had disabling stroke, 0.4% residual aortic regurgitation ≥2°, and the incidence of new-onset pacemaker/implantable cardioverter-defibrillator implantation was 3.9%. There was an increase in the use of biological valves in patients <65 years (50.1-65.7%, P < 0.001), and the proportion of rapid deployment valves increased significantly (1.5-8.4%, P < 0.001) over the investigated time period. CONCLUSIONS: Both isolated sAVR as well as sAVR + CABG resulted in excellent in-hospital outcomes based on >42 000 patients treated between 2011 and 2015. The implementation of alternative treatment strategies has resulted in palpable changes in patient and device selection.