Comparison of a Pure Plug-Based Versus a Primary Suture-Based Vascular Closure Device Strategy for Transfemoral Transcatheter Aortic Valve Replacement: The CHOICE-CLOSURE Randomized Clinical Trial.

BACKGROUND: Transcatheter aortic valve replacement is an established treatment option for patients with severe symptomatic aortic stenosis and is most commonly performed through the transfemoral access route. Percutaneous access site closure can be achieved using dedicated plug-based or suture-based vascular closure device (VCD) strategies, but randomized comparative studies are scarce. METHODS: The CHOICE-CLOSURE trial (Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure during Transfemoral Transcatheter Aortic Valve Implantation) is an investigator-initiated, multicenter study, in which patients undergoing transfemoral transcatheter aortic valve replacement were randomly assigned to vascular access site closure using either a pure plug-based technique (MANTA, Teleflex) with no additional VCDs or a primary suture-based technique (ProGlide, Abbott Vascular) potentially complemented by a small plug. The primary end point consisted of access site- or access-related major and minor vascular complications during index hospitalization, defined according to the Valve Academic Research Consortium-2 criteria. Secondary end points included the rate of access site- or access-related bleeding, VCD failure, and time to hemostasis. RESULTS: A total of 516 patients were included and randomly assigned. The mean age of the study population was 80.5±6.1 years, 55.4% were male, 7.6% of patients had peripheral vascular disease, and the mean Society of Thoracic Surgeons score was 4.1±2.9%. The primary end point occurred in 19.4% (50/258) of the pure plug-based group and 12.0% (31/258) of the primary suture-based group (relative risk, 1.61 [95% CI, 1.07-2.44], P=0.029). Access site- or access-related bleeding occurred in 11.6% versus 7.4% (relative risk, 1.58 [95%CI: 0.91-2.73], P=0.133) and device failure in 4.7% versus 5.4% (relative risk, 0.86, [95% CI, 0.40-1.82], P=0.841) in the respective groups. Time to hemostasis was significantly shorter in the pure plug-based group (80 [32-180] versus 240 [174-316] seconds, P<0.001). CONCLUSIONS: Among patients treated with transfemoral transcatheter aortic valve replacement, a pure plug-based vascular closure technique using the MANTA VCD is associated with a higher rate of access site- or access-related vascular complications but a shorter time to hemostasis compared with a primary suture-based technique using the ProGlide VCD. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04459208.

Impact of Anesthesia Strategy and Valve Type on Clinical Outcomes After Transcatheter Aortic Valve Replacement.

BACKGROUND: The randomized SOLVE-TAVI (compariSon of secOnd-generation seLf-expandable vs. balloon-expandable Valves and gEneral vs. local anesthesia in Transcatheter Aortic Valve Implantation) trial compared newer-generation self-expanding valves (SEV) and balloon-expandable valves (BEV) as well as local anesthesia with conscious sedation (CS) and general anesthesia (GA) in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). Both strategies showed similar outcomes at 30 days. OBJECTIVES: The purpose of this study was to compare clinical outcomes during 1-year follow-up in the randomized SOLVE-TAVI trial. METHODS: Using a 2 × 2 factorial design 447 intermediate- to high-risk patients with severe, symptomatic aortic stenosis were randomly assigned to transfemoral TAVR using either the SEV (Evolut R, Medtronic Inc., Minneapolis, Minnesota) or the BEV (Sapien 3, Edwards Lifesciences, Irvine, California) as well as CS or GA at 7 sites. RESULTS: In the valve-comparison strategy, rates of the combined endpoint of all-cause mortality, stroke, moderate or severe paravalvular leakage, and permanent pacemaker implantation were similar between the BEV and SEV group (n = 84, 38.3% vs. n = 87, 40.4%; hazard ratio: 0.94; 95% confidence interval: 0.70 to 1.26; p = 0.66) at 1 year. Regarding the anesthesia comparison, the combined endpoint of all-cause mortality, stroke, myocardial infarction, and acute kidney injury occurred with similar rates in the GA and CS groups (n = 61, 25.7% vs. n = 54, 23.8%; hazard ratio: 1.09; 95% confidence interval: 0.76 to 1.57; p = 0.63). CONCLUSIONS: In intermediate- to high-risk patients undergoing transfemoral TAVR, newer-generation SEV and BEV as well as CS and GA showed similar clinical outcomes at 1 year using a combined clinical endpoint. (SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI [SOLVE-TAVI]; NCT02737150).

General Versus Local Anesthesia With Conscious Sedation in Transcatheter Aortic Valve Implantation: The Randomized SOLVE-TAVI Trial.

BACKGROUND: In clinical practice, local anesthesia with conscious sedation (CS) is performed in roughly 50% of patients undergoing transcatheter aortic valve replacement. However, no randomized data assessing the safety and efficacy of CS versus general anesthesia (GA) are available. METHODS: The SOLVE-TAVI (Comparison of Second-Generation Self-Expandable Versus Balloon-Expandable Valves and General Versus Local Anesthesia in Transcatheter Aortic Valve Implantation) trial is a multicenter, open-label, 2×2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement comparing CS versus GA. The primary efficacy end point was powered for equivalence (equivalence margin 10% with significance level 0.05) and consisted of the composite of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury at 30 days. RESULTS: The primary composite end point occurred in 27.2% of CS and 26.4% of GA patients (rate difference, 0.8 [90% CI, -6.2 to 7.8]; Pequivalence=0.015). Event rates for the individual components were as follows: all-cause mortality, 3.2% versus 2.3% (rate difference, 1.0 [90% CI, -2.9 to 4.8]; Pequivalence<0.001); stroke, 2.4% versus 2.8% (rate difference, -0.4 [90% CI, -3.8 to 3.8]; Pequivalence<0.001); myocardial infarction, 0.5% versus 0.0% (rate difference, 0.5 [90% CI, -3.0 to 3.9]; Pequivalence<0.001), infection requiring antibiotics 21.1% versus 22.0% (rate difference, -0.9 [90% CI, -7.5 to 5.7]; Pequivalence=0.011); acute kidney injury, 9.0% versus 9.2% (rate difference, -0.2 [90% CI, -5.2 to 4.8]; Pequivalence=0.0005). There was a lower need for inotropes or vasopressors with CS (62.8%) versus GA (97.3%; rate difference, -34.4 [90% CI, -41.0 to -27.8]). CONCLUSIONS: Among patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement, use of CS compared with GA resulted in similar outcomes for the primary efficacy end point. These findings suggest that CS can be safely applied for transcatheter aortic valve replacement. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02737150.

Comparison of newer generation self-expandable vs. balloon-expandable valves in transcatheter aortic valve implantation: the randomized SOLVE-TAVI trial.

AIMS: Transcatheter aortic valve implantation (TAVI) has emerged as established treatment option in patients with symptomatic aortic stenosis. Technical developments in valve design have addressed previous limitations such as suboptimal deployment, conduction disturbances, and paravalvular leakage. However, there are only limited data available for the comparison of newer generation self-expandable valve (SEV) and balloon-expandable valve (BEV). METHODS AND RESULTS: SOLVE-TAVI is a multicentre, open-label, 2 × 2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral TAVI comparing SEV (Evolut R, Medtronic Inc., Minneapolis, MN, USA) with BEV (Sapien 3, Edwards Lifesciences, Irvine, CA, USA). The primary efficacy composite endpoint of all-cause mortality, stroke, moderate/severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days was powered for equivalence (equivalence margin 10% with significance level 0.05). The primary composite endpoint occurred in 28.4% of SEV patients and 26.1% of BEV patients meeting the prespecified criteria of equivalence [rate difference -2.39 (90% confidence interval, CI -9.45 to 4.66); Pequivalence = 0.04]. Event rates for the individual components were as follows: all-cause mortality 3.2% vs. 2.3% [rate difference -0.93 (90% CI -4.78 to 2.92); Pequivalence < 0.001], stroke 0.5% vs. 4.7% [rate difference 4.20 (90% CI 0.12 to 8.27); Pequivalence = 0.003], moderate/severe paravalvular leak 3.4% vs. 1.5% [rate difference -1.89 (90% CI -5.86 to 2.08); Pequivalence = 0.0001], and permanent pacemaker implantation 23.0% vs. 19.2% [rate difference -3.85 (90% CI -10.41 to 2.72) in SEV vs. BEV patients; Pequivalence = 0.06]. CONCLUSION: In patients with aortic stenosis undergoing transfemoral TAVI, newer generation SEV and BEV are equivalent for the primary valve-related efficacy endpoint. These findings support the safe application of these newer generation percutaneous valves in the majority of patients with some specific preferences based on individual valve anatomy.

Effects of ß-Adrenoceptor and Catechol-O-Methyl-Transferase (COMT) Polymorphism on Postoperative Outcome in Cardiac Surgery Patients.

BACKGROUND There is a long-standing debate about the role of beta-adrenoceptor polymorphisms in the cardiovascular system. We wanted to elucidate whether ß1-adrenoceptor-polymorphisms affects the postoperative catecholamine consumption and the length of intermediate care unit stay in patients undergoing cardiac surgery, and whether this might be enhanced or attenuated by catechol-O-methyl-transferase (COMT) polymorphism. MATERIAL AND METHODS We included 116 patients (63±1.2 years; 34% females; 81±1 kg) undergoing cardiac surgery. We assessed Arg389Gly and Ser49Gly-ß1-adrenoceptor (B1AR) polymorphism together with Val158Met-COMT polymorphism by real-time PCR using fluorescence resonance energy transfer (PCR-FRET). The preoperative risk was assessed by EuroSCORE. In addition, we measured the endogenous preoperative epinephrine and norepinephrine plasma concentrations using an electrochemical HPLC method. RESULTS 84.6% were homozygous for Ser49Ser, 52.1% homozygous for Arg389Arg B1AR, and 32.5% for Val158Val-COMT, while 15.4% showed Ser49Gly B1AR, 38.5% Arg389Gly-B1AR, and 35.6% Val158Met-COMT. We found that the Gly49-variant, the Gly389-variant, and the Val158-COMT-variant were associated with higher postoperative norepinephrine consumption. All patients carrying the Val158-COMT allele exhibited higher preoperative norepinephrine concentrations. Moreover, we found that both ß1-adrenoceptor polymorphisms were associated with a longer stay in hospital, which was modulated by the COMT polymorphism. CONCLUSIONS These data show that the ß1-adrenoceptor polymorphisms, together with the COMT polymorphism, affect norepinephrine consumption and stay in hospital in a situation of enhanced cardiovascular stress, reflected here by the postoperative period after cardiac surgery. Moreover, we conclude that patients with the Val158-COMT genotype exhibit higher endogenous resting plasma norepinephrine levels.

Quality of Life After Transcatheter Aortic Valve Replacement: Prospective Data From GARY (German Aortic Valve Registry).

OBJECTIVES: This study sought to analyze health-related quality-of-life (HrQoL) outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) based on data from GARY (German Aortic Valve Registry). BACKGROUND: Typically, patients currently referred for and treated by TAVR are elderly with a concomitant variable spectrum of multiple comorbidities, disabilities, and limited life expectancy. Beyond mortality and morbidity, the assessment of HrQoL is of paramount importance not only to guide patient-centered clinical decision-making but also to judge this new treatment modality in this high-risk patient population. METHODS: In 2011, 3,875 patients undergoing TAVR were included in the GARY registry. HrQoL was prospectively measured using the EuroQol 5 dimensions questionnaire self-complete version on paper at baseline and 1 year. RESULTS: Complete follow-up EuroQol 5 dimensions questionnaire evaluation was available for 2,288 patients (transvascular transcatheter aortic valve replacement [TAVR-TV]: n = 1,626 and transapical TAVR [TAVR-TA]: n = 662). In-hospital mortality was 5.9% (n = 229) and the 1-year mortality was 23% (n = 893). The baseline visual analog scale score for general health status was 52.6% for TAVR-TV and 55.8% for TAVR-TA and, in parallel to an improvement in New York Heart Association functional class, improved to 59.6% and 58.5% at 1 year, respectively (p < 0.001). Between baseline and 1 year, the number of patients reporting no complaints increased by 7.8% (TAVR-TV) and by 3.5% within the mobility dimension, and by 14.1% (TAVR-TV) and 9.2% within the usual activity dimension, whereas only moderate changes were found for the self-care, pain or discomfort, and anxiety or depression dimensions. In a multiple linear regression analysis several pre- and post-operative factors were predictive for less pronounced HrQoL benefits. CONCLUSIONS: TAVR treatment led to improvements in HrQoL, especially in terms of mobility and usual activities. The magnitude of improvements was higher in the TAVR-TV group as compared to the TAVR-TA group. However, there was a sizable group of patients who did not derive any HrQoL benefits. Several independent pre- and post-operative factors were identified being predictive for less pronounced HrQoL benefits.

Porcine xenograft for aortic, mitral and double valve replacement: long-term results of 2544 consecutive patients.

OBJECTIVES: The aim of this study was to evaluate the results after stented porcine xenograft implantation with Linx™ anticalcification treatment in the aortic and/or mitral position in elderly patients. METHODS: Over a decade, a total of 2544 patients receiving aortic (AVR = 1920), mitral (MVR = 347) or double valve (DVR = 277) replacement (between November 2001 and March 2012) were evaluated. The study was designed on an 'all comers' basis including all patients with elective, urgent or emergent need for valve replacement. Outcome was assessed by reviewing the prospectively acquired hospital database as well as regular follow-up information obtained by annual written interviews. RESULTS: Mean patient age was 76.5 ± 6 (AVR), 73.8 ± 7 (MVR) and 74.2 ± 7 (DVR) years, respectively; 54.2%/41.9%/42.0% were male, and active endocarditis was diagnosed in 4.5%/19.9%/22.1%; indication for valve surgery and the logistic EUROSCORE I predicted risk for mortality was 15.4 ± 15%/19.9 ± 19%/22.3 ± 21%, respectively. Concomitant mitral valve repair was required in 196 (10.2%) (AVR) patients; coronary artery bypass graft surgery (CABG) in 840 (43.8%) (AVR), 82 (23.7%) (MVR) and 94 (34.1%) (DVR) patients; cryoablation in 232 (12.1%)/81 (23.4%)/67 (24.3%) patients and surgery on the thoracic aorta in 166 (8.7%)/12 (3.5%)/41 (14.9%) patients, respectively. The mean follow-up was 4.5 ± 3.5 years. The rate of freedom from endocarditis after 10 years was 98.3 ± 0.4%/97.5 ± 1.0%/97.4 ± 1.6% (P = n.s.). The rate of freedom from structural valve disease was 96.3 ± 0.6%/93.8 ± 2.4%/92.8 ± 2.2% (AVR versus DVR, P = 0.009), and from thromboembolic events was 94.8 ± 1.0%/91.5 ± 2.9%/97.9 ± 1.3%. The 30-day survival rate was 97.3 ± 0.4%/95.1 ± .1.2%/92.8 ± 1.6% and the 10-year survival rate was 42.1 ± 1.5%/33.9 ± 4.7%/22.1 ± 7.1%, respectively. CONCLUSIONS: The Epic™ stented porcine xenograft is associated with acceptable survival, with large proportions of patients free from valve-related complications and freedom from valve reintervention for all older, in-coming patients.

Cardiac Surgery in Germany during 2014: A Report on Behalf of the German Society for Thoracic and Cardiovascular Surgery.

Based on a voluntary registry of the German Society for Thoracic and Cardiovascular Surgery (GSTCVS), data of all heart surgery procedures performed in 78 German cardiac surgical units during the year 2014 are presented. In 2014, a total of 100,398 cardiac surgical procedures (implantable cardioverter-defibrillator and pacemaker procedures excluded) were submitted to the registry. More than 14.2% of the patients were older than 80 years, describing an increase of 0.4% compared with the previous year. The unadjusted in-hospital mortality for 40,006 isolated coronary artery bypass grafting procedures (84.7% on-pump, 15.3% off-pump) was 2.6%. In 31,359 isolated valve procedures (including 9,194 catheter-based procedures), an in-hospital mortality of 4.4% was observed. This annual updated registry of the GSTCVS is published since 1989. It is an important tool for quality assurance and voluntary public reporting by illustrating current standards and actual developments for nearly all cardiac surgical procedures in Germany.

The German Aortic Valve Registry: 1-year results from 13,680 patients with aortic valve disease.

OBJECTIVES: The German Aortic Valve Registry (GARY) seeks to provide information on a real-world, all-comers basis for patients undergoing aortic valve interventions. This registry comprises patients undergoing the complete spectrum of transcutaneous and conventional surgical aortic valve interventions. The aim of this study was to use the GARY registry to evaluate conventional and catheter-based aortic valve interventions in several risk groups. METHODS: A total of 13 860 consecutive patients undergoing intervention for aortic valve disease [conventional aortic valve replacement (AVR) or transvascular/transapical TAVR (TV-/TA-TAVR)] were enrolled in 78 German centres in 2011. Baseline, procedural and outcome data, including quality of life, were acquired up to 1 year post-intervention. Vital status at 1 year was known for 98.1% of patients. RESULTS: The 1-year mortality rate was 6.7% for conventional AVR patients (n = 6523) and 11.0% for patients who underwent AVR with coronary artery bypass grafting (n = 3464). The 1-year mortality rate was 20.7 and 28.0% in TV- and TA-TAVR patients, respectively (n = 2695 and 1181). However, if patients were stratified into four risk groups by means of the EuroSCORE and the German AV Score, the highest risk cohorts showed the same mortality at 1 year with either therapy. More than 80% of patients in all groups were in the same or better state of health at 1 year post-intervention and were satisfied with the procedural outcome. CONCLUSIONS: Conventional AVR surgery yields excellent results after 1 year in lower-risk patients. Catheter-based AVR is a good alternative in high-risk and elderly patients.

The German Aortic Valve Registry (GARY): in-hospital outcome.

BACKGROUND: Aortic stenosis is a frequent valvular disease especially in elderly patients. Catheter-based valve implantation has emerged as a valuable treatment approach for these patients being either at very high risk for conventional surgery or even deemed inoperable. The German Aortic Valve Registry (GARY) provides data on conventional and catheter-based aortic procedures on an all-comers basis. METHODS AND RESULTS: A total of 13 860 consecutive patients undergoing repair for aortic valve disease [conventional surgery and transvascular (TV) or transapical (TA) catheter-based techniques] have been enrolled in this registry during 2011 and baseline, procedural, and outcome data have been acquired. The registry summarizes the results of 6523 conventional aortic valve replacements without (AVR) and 3464 with concomitant coronary bypass surgery (AVR + CABG) as well as 2695 TV AVI and 1181 TA interventions (TA AVI). Patients undergoing catheter-based techniques were significantly older and had higher risk profiles. The stroke rate was low in all groups with 1.3% (AVR), 1.9% (AVR + CABG), 1.7% (TV AVI), and 2.3% (TA AVI). The in-hospital mortality was 2.1% (AVR) and 4.5% (AVR + CABG) for patients undergoing conventional surgery, and 5.1% (TV AVI) and AVI 7.7% (TA AVI). CONCLUSION: The in-hospital outcome results of this registry show that conventional surgery yields excellent results in all risk groups and that catheter-based aortic valve replacements is an alternative to conventional surgery in high risk and elderly patients.

Cardiac surgery in Germany during 2012: a report on behalf of the German Society for Thoracic and Cardiovascular Surgery.

On the basis of a voluntary registry of the German Society for Thoracic and Cardiovascular Surgery (GSTCVS), data of all cardiac surgical procedures performed in 79 German cardiac surgical units during the year 2012 are presented. In 2012, a total of 98,792 cardiac surgical procedures (ICD and pacemaker procedures excluded) were submitted to the registry. More than 13.8% of the patients were older than 80 years, which is a further increase in comparison to previous years. In-hospital mortality in 42,060 isolated coronary artery bypass grafting procedures (84.6% on-pump and 15.4% off-pump) was 2.9%. In 28,521 isolated valve procedures (including 6,804 catheter-based procedures), an in-hospital mortality of 4.8% was observed. This long-lasting registry of the GSTCVS will continue to be an important tool for quality control and voluntary public reporting by illustrating current facts and developments of cardiac surgery in Germany.

Isolated tricuspid valve surgery in patients with previous cardiac surgery.

OBJECTIVES: Few studies have been published in literature on outcomes of isolated tricuspid valve (TV) surgery when performed as a reoperation. Hence, we analyzed our early and midterm results of TV surgery in this unique group of patients. METHODS: We performed a retrospective analysis of 82 consecutive patients who underwent isolated TV surgery as a reoperation at our institution between 1997 and 2010. Symptomatic TV regurgitation (84.2%), acute endocarditis (14.6%), and valve thrombosis after TV repair (1.2%) were the indications for surgery. A minimally invasive access through a right anterolateral thoracotomy was the preferred approach in 60% of the patients. Previous cardiac operations included mitral, aortic, and TV surgery in 60%, 29%, and 27% and coronary bypass surgery in 18%, usually performed as combined procedures. Elective surgery was performed in 67.1% of the patients. Mean patient age was 64.1 ± 11.9 years, 28% being male with an average logistic EuroSCORE of 16.4% ± 14.3%. Follow-up was 96% complete, with a mean duration of 2.6 ± 2.4 years. RESULTS: Overall thirty-day mortality was 14.6%; for patients without and with endocarditis, it was 12.9% and 25%. Thirty-day mortality for patients undergoing elective surgery was 4.0%. Overall 2-year survival was 63.0% ± 5.5%. The 2-year freedom from TV-related reoperation was 93.5% ± 3.3%. CONCLUSIONS: Postoperative results of isolated TV surgery as a reoperation are acceptable when performed electively but dismal in patients undergoing nonelective surgery. Thus, redo TV surgery, when indicated, should be performed sooner rather than later. Minimally invasive surgery through a right lateral minithoracotomy is a safe approach for patients with elective surgery.

Cardiac surgery in Germany during 2011: a report on behalf of the German Society for Thoracic and Cardiovascular Surgery.

All cardiac surgical procedures performed in 78 German cardiac surgical units throughout the year 2011 are presented in this report, based on a voluntary registry which is organized by the German Society for Thoracic and Cardiovascular Surgery. In 2011, a total of 100,291 cardiac surgical procedures (implantable cardioverter defibrillator and pacemakers procedures excluded) have been collected in this registry. More than 13.4% of the patients were older than 80 years compared with 12.4% in 2010. Hospital mortality in 41,976 isolated coronary artery bypass graft procedures (14.7% off-pump) was 2.9%. In 26,972 isolated valve procedures (including 5,210 catheter-based procedures), an in-hospital mortality of 5.2% has been observed.This voluntary registry of the German Society for Thoracic and Cardiovascular Surgery will continue to be an important tool enabling quality control and illustrating current facts and the development of cardiac surgery in Germany.

Isolated reoperative minimally invasive tricuspid valve operations.

BACKGROUND: Tricuspid valve (TV) regurgitation has recently been identified as a major risk factor for long-term mortality. Isolated reoperative tricuspid valve repair/replacement (TVR/r) carries an excessively high operative risk. Currently, isolated TVR/r with minimally invasive access through a right lateral thoracotomy is being used increasingly in our institution to treat progressive TV pathologic processes after previous cardiac operations. We analyzed our early and midterm results with reoperative TVR/r in this unique patient cohort. METHODS: Forty-eight consecutive patients underwent isolated TV operations after previous cardiac operations with minimally invasive access through a right lateral thoracotomy at our institution between September 2000 and December 2011. Previous cardiac operations included 26 patients (54.2%) with mitral valve replacement/repair, 18 patients (37.5%) with an aortic valve replacement, 10 patients (20.4%) with a TVR/r, and 8 patients (16.7%) with coronary artery bypass grafting. Operations were performed electively in 79% of patients (n=38). Mean patient age was 63.8±13.4 years, with an average log EuroSCORE of 13.9%±11.3%; 67% of patients were women. Follow-up was 94% complete, with a mean duration of 2.8±2.3 years. RESULTS: Thirty-day mortality for patients undergoing elective surgery was zero. For all patients early mortality was 4.2%. Five-year survival for patients after elective reoperative TVR/r through minimally invasive access was 72.2%±10.0%, and 5-year freedom from TV-related reoperations was 88.1%±6.7%, respectively. CONCLUSIONS: Minimally invasive access through a right thoracotomy provides a safe option for reoperative TVR and offers excellent early outcome, particularly in elective cases. Surgical intervention should be performed earlier rather than later.

Visceral arterial compromise during intra-aortic balloon counterpulsation therapy.

BACKGROUND: Intraaortic balloon pump (IABP) therapy is a widely used method of circulatory support. Based on frequent findings of balloon malposition with visceral arterial compromise on computerized tomographic (CT) imaging studies, we conducted a systematic review of cardiac surgical IABP patients with available CT scans to determine reasons, incidence, and clinical relevance of malposition. METHODS AND RESULTS: From January 2007 to March 2009, a total of 621 of 7756 cardiac surgical patients (8.0%) received perioperative IABP support, of whom 63 (10.1%) received a thoracoabdominal CT scan during IABP support. Proximal and distal balloon positions were analyzed. The anatomic distance from the left subclavian artery to celiac trunk and aortic transverse diameter were measured in all patients and compared with implanted balloon dimensions. Mean age was 67.1±11.9 years; 33.3% were female, and height was 169±9 cm. Based on radiography, proximal balloon position was correct in 96.8% but only appropriate in 38.1% based on CT. In 61 of 63 patients, compromise of at least 1 visceral artery was found: celiac trunk, 96.8%; superior mesenteric artery, 87.3%; and renal arteries, 66.7%. Left subclavian artery to celiac trunk distance was 241±23 mm, and balloon length was 248±17 mm and corresponded to an anatomic to balloon length mismatch in 68.2%. Spinal deformations were found in 42.9%. Laparotomy for mesenteric ischemia was required in 23.8%. Hospital mortality rate was 60.3%. CONCLUSIONS: IABP malposition was commonly identified by CT. Reasons included incorrect proximal balloon position as well as an anatomic-to-balloon length mismatch. Thus, shorter than recommended balloon sizes and better positioning strategies had to be considered.

Cardiac surgery fast-track treatment in a postanesthetic care unit: six-month results of the Leipzig fast-track concept.

BACKGROUND: The authors compared the safety and efficacy of a newly developed fast-track concept at their center, including implementation of a direct admission postanesthetic care unit, to standard perioperative management. METHODS: All fast-track patients treated within the first 6 months of implementation of our direct admission postanesthetic care unit were matched via propensity scores and compared with a historical control group of patients who underwent cardiac surgery prior to fast-track implementation. RESULTS: A total of 421 fast-track patients were matched successfully to 421 control patients. The two groups of patients had a similar age (64 +/- 13 vs. 64 +/- 12 yr for fast-track vs. control, P = 0.45) and European System for Cardiac Operative Risk Evaluation-predicted risk of mortality (4.8 +/- 6.1% vs. 4.6 +/- 5.1%, P = 0.97). Fast-track patients had significantly shorter times to extubation (75 min [45-110] vs. 900 min [600-1140]), as well as shorter lengths of stay in the postanesthetic or intensive care unit (4 h [3.0-5] vs. 20 h [16-25]), intermediate care unit (21 h [17-39] vs. 26 h [19-49]), and hospital (10 days [8-12] vs. 11 days [9-14]) (expressed as median and interquartile range, all P < 0.01). Fast-track patients also had a lower risk of postoperative low cardiac output syndrome (0.5% vs. 2.9%, P < 0.05) and mortality (0.5% vs. 3.3%, P < 0.01). CONCLUSION: The Leipzig fast-track protocol is a safe and effective method to manage cardiac surgery patients after a variety of operations.

Emergency coronary artery bypass graft surgery for acute coronary syndrome: beating heart versus conventional cardioplegic cardiac arrest strategies.

BACKGROUND: Aim of this study was to compare the outcome of beating heart versus conventional coronary artery bypass graft (CABG) strategies in acute coronary syndromes for emergency indications. METHODS AND RESULTS: 638 consecutive patients with acute coronary syndrome (ACS) receiving emergency CABG surgery via midline sternotomy from January 2000 to September 2005 were evaluated. Propensity score analysis was used to predict the probability of undergoing beating heart (BH) (n=240) versus cardioplegic cardiac arrest (CA) (n=398) strategies. Patients presented with stable hemodynamics (n=531) or in cardiogenic shock (CS) (n=107). Hospital and follow-up outcome was compared by propensity score adjusted multiregression analysis. BH included 116 on-pump and 124 off-pump (OPCAB) procedures. There was a propensity to operate CS patients on the beating heart (multivariate odds ratio [OR], 3.8; P=0.001). Under stable hemodynamics significant predictors for BH selection were logEuroSCORE >20% (OR, 2.05), creatinine >1.8 mg/dL (OR, 4.12), complicated percutaneous coronary intervention (OR, 1.88), ejection fraction <30% (OR, 2.64), whereas left main disease (OR, 0.68), circumflex artery (OR, 0.32), and 3-vessel disease (OR, 0.67) indicated preference for cardioplegic arrest. Time from skin incision to culprit lesion revascularization was significantly reduced in BH patients. BH surgery led to a significant benefit in terms of less drainage loss, less transfusion requirement, less inotropic support, shorter ventilation time, lower stroke rate, and shorter intensive care unit stay. In CS, BH was associated with lower incidence of stroke, inotropic support, acute renal failure, new atrial fibrillation and sternal wound healing complications. In CS patients, hospital mortality rate was reduced when using beating heart strategies (P=0.048). Overall survival, major adverse cerebral and cardiovascular event rate, and repeated revascularization was comparable during a 5-year follow-up. CONCLUSIONS: Beating heart strategies are associated with an improved hospital outcome and comparable long-term results for high-risk patients presenting acute coronary syndrome with or without CS.