Thomas Breymann

Bovine valved venous xenografts for RVOT reconstruction: results after 71 implantations

BACKGROUNDnPediatric right ventricular outflow tract (RVOT) reconstruction with homo- or porcine xenografts is problematic because of limited availability, lack of material for reconstruction, early degeneration, and tissue ingrowth. Contegra, a bovine jugular vein graft, might be an interesting alternative to overcome these problems.nnnPATIENTS AND METHODSnWithin a Federal Drug Administration controlled study, we implanted 71 Contegra pulmonary valved conduits from May 1999 to September 2001 in 71 patients (male/female 33/38) in the age range 2 days-17.4 years, median 1.2 years. Twenty five were primary repairs, 22 had previous graft implantations, and 24 had other repairs/palliations. Preoperative diagnoses: truncus arteriosus communis (19 patients), tetralogy of Fallot (32), double outlet right ventricle (13), transposition of the great arteries (5), and two rare complex malformations. The size of implanted Contegra conduits ranged from 12 to 22 mm. Echocardiography was performed at 1 and 3 months, and then every 3 months postoperatively. Follow-up time was 27 months (maximal), 80 years in total. Results were compared with our 52 homograft- and 30 Tissuemed porcine xenograft recipients.nnnRESULTSnContegra enables the surgeon to perform all anastomoses without additional material. Its tissue is very apt for suturing and its insufficiencies are common, but without clinical significance or tendency to increase. We saw no sign of conduit or valve degeneration during the whole follow-up up to 27 months. There were no device related adverse events. Redos: five for peripheral pulmonary arteries, two residual ventricular septum defect (VSD) closures. There were six deaths (five early, one late). The maximal transvalvular gradients of 25-42 mmHg were measured in seven patients; these gradients did not increase further during the follow-up. Six patients with completely intact Contegra conduits developed pressure gradients of more than 70 mmHg immediately distal from the conduit. At 27 months, Contegra grafts were advantageous compared to homografts with respect to survival and freedom from explantation. Right ventricle to left ventricle (RV/LV) ratio development and freedom from explantation/redo were equal for Contegra conduits and homografts. Porcine Tissuemed xenografts were significantly inferior.nnnCONCLUSIONnThe Contegra conduit offers unique tailoring and suturing options for primary and redo RVOT reconstruction. At 27 months, its durability seems at least equivalent to homografts and is superior to porcine Tissuemed xenografts.

Mechanical circulatory support: The Bad Oeynhausen experience

From September 1987 to February 1994, we treated 147 patients ranging between 11 and 82 years old with different mechanical circulatory support systems. The applied devices were the Bio-Medicus centrifugal pump in 61 patients, the Abiomed BVS System 5000 in 49 patients, the Thoratec ventricular assist device in 42 patients, and the Novacor left ventricular assist device in 7 patients. On the basis of indication for mechanical circulatory support, the patients were divided into three groups: group 1 consisted of 72 patients with postcardiotomy cardiogenic shock; group 2, 50 patients in whom mechanical support was used as a bridge to cardiac transplantation; and group 3 (miscellaneous), 25 patients in cardiogenic shock resulting from acute myocardial infarction (n = 14), acute fulminant myocarditis (n = 3), primary graft failure (n = 2), right heart failure after heart transplantation (n = 3), and acute rejection (n = 3). Time of support ranged from 1 hour to 97 days (mean duration, 10.8 days). Seventy-five patients (51%) were discharged from the hospital. The best survival rate was achieved in group 2 with 72%, followed by group 1 with 44% and then group 3 with 28%. The most frequent complications in group 1 were bleeding (44%), multiple-organ failure (24%), neurologic disorders (18%), and acute renal failure (15%). In group 2, the major complications were bleeding (34%) and cerebrovascular disorders (22%) and in group 3, multiple-organ failure and sepsis (60%) and bleeding (32%).

Temporary pulsatile ventricular assist devices and biventricular assist devices

BACKGROUNDnDuring the past years several systems for mechanical circulatory support have become available. In this study we describe our experience with short-term and mid-term application of the ABIOMED and Thoratec device.nnnMETHODSnSince 1990 the ABIOMED BVS and since 1992 the Thoratec VAD have been applied to 75 and 103 patients, respectively, with postcardiotomy heart failure, as a bridge-to-transplant procedure, and with different other indications.nnnRESULTSnIn the ABIOMED collective 25 of 50 patients (50%) with postcardiotomy heart failure and 1 of 4 patients with miscellaneous other indications could be discharged from hospital, 7 of 14 bridge-to-transplant patients (50%) underwent transplantation with a posttransplant survival of 86%. In the Thoratec collective 6 of 10 patients (60%) with postcardiotomy heart failure and 4 of 8 patients (50%) with miscellaneous indications could be discharged from hospital, 48 bridge-to-transplant patients (74%) underwent transplantation with a posttransplant survival of 90%.nnnCONCLUSIONSnThe results show the versatility of the Thoratec VAD for short-term and mid-term application in patients with postcardiotomy heart failure and as a bridge-to-transplant procedure. The use of the ABIOMED device is not indicated for bridging patients to transplantation. Although in case of postcardiotomy heart failure, Thoratec is also superior to ABIOMED, the high costs of the Thoratec VAD limits its wide acceptance in this patient cohort.

[INR self-management after mechanical heart valve replacement: ESCAT (Early Self-Controlled Anticoagulation Trial)].

Severe thromboembolic and hemorrhagic complications following mechanical heart valve replacement essentially occur due to intense oral anticoagulation and fluctuating individual INR values around the target range. INR self-management can help to minimize these fluctuations. Beginning this therapeutic control immediately after mechanical heart valve replacement further reduces anticoagulant-induced complications. Included in the study were 1200 patients. The quality of oral anticoagulation also improved through INR self-management. Over an observation period of two years, nearly 80 % of INR values recorded by the patients themselves were within the target therapeutic range of 2.5–4.5. This corresponds to a high significance of p < = 0.001 in favor of INR self-management. Only 64.9 % of INR values monitored by family practitioners were within the desired range. The results differed slightly in quality between patient groups with different levels of training (comprehensive, secondary modern, grammar with or without university). Of patients trained in INR self-management following mechanical heart valve replacement, 91.7 % maintained their competence in this technique throughout the entire follow-up period. Only 8.3 % of those trained immediately after surgery were unable to continue with INR self-management. Grundproblematik und Methodik Das Auftreten von schwerwiegenden, thrombembolischen und hämorrhagischen Komplikationen nach mechanischem Herzklappenersatz ist im Wesentlichen abhängig von der Intensität der oralen Antikoagulation und der Schwankung der einzelnen INR-Messwerte um den Zielbereich. Das INR-Selbstmanagement ist in der Lage, diese Schwankungen zu minimieren. Insbesondere durch den frühen postoperativen Beginn dieser Therapiekontrolle wird eine weitere Reduktion von antikoagulanzieninduzierten Komplikationen bewirkt. Mit dieser Arbeit soll geklärt werden, inwieweit ein unmittelbar postoperativ eingeführtes INR-Selbstmanagement nach mechanischem Herzklappenersatz zu einer verbesserten Therapiecompliance und hieraus resultierend zu einer Reduktion der thrombembolischen Komplikationsrate führt. Patienten und Methodik Insgesamt wurden 1200 Patienten in die ESCAT-Studie eingeschlossen, hiervon konnten 45 Patienten bei der Auswertung nicht berücksichtigt werden, da in 29 Fällen biologische Herzklappen implantiert wurden und 16 Patienten (1,3 %) nicht in der Lage waren, das Studienprotokoll zu erfüllen, somit ergab sich eine Grundpopulation von 1155 Patienten. Entsprechend der Randomisierung entfielen 576 Patienten (49,9 %) in die konventionelle Gruppe, in welcher die Antikoagulationstherapie vom Hausarzt durchgeführt wurde. Auf die Gruppe der Patienten, welche das INR-Selbstmanagement durchführten, entfielen 579 Patienten (50,1 %). Die INR-Werte und Komplikationsereignisse wurden in monatlichen Intervallen mittels Patientenprotokollbogen an das Studienzentrum geschickt. Ergebnisse Die INR-Selbstmanagementgruppe hatte signifikant weniger schwerwiegende Thrombembolien (p = 0,026). Das INR-Selbstmanagement bewirkt eine hohe Qualitatsverbesserung der laufenden oralen Antikoagulation. Annahernd 80 % der von den Patienten ermittelten INR-Werte lagen im vorgegebenen Therapiekorridor von INR 2,5–4,5. Hieraus resultiert eine hochst signifikante Differenz mit p ≤ 0,001 zugunsten des INR-Selbstmanagements. Nur 64,9 % der INR-Werte der konventionell kontrollierten Patienten lagen im gewunschen Therapiebereich. Die thrombembolische Komplikationsrate konnte von 2,8 % pro Patientenjahr auf 1,5 % pro Patientenjahr reduziert werden, unabhangig von der gewahlten Klappenposition, allein durch einen fruhen Beginn des INR-Selbstmanagements unmittelbar nach einem mechanischem Herzklappenersatz. Folgerung 91,7% der Patienten mit Einfuhrung ins INR-Selbstmanagement nach mechanischem Herzklappenersatz zeigten uber die gesamte Follow-up-Zeit ihre Kompetenz hinsichtlich des INR-Selbstmanagements. Nur 8,3 % der Patienten gaben ihren INR-Gerinnungsmonitor zuruck. Sie fuhlten sich nicht in der Lage, das INR-Selbstmanagement durchzufuhren. Insgesamt konnte eine signifikante thrombembolische Komplikationsreduktion nachgewiesen werden.

Results after Norwood procedure and subsequent cavopulmonary anastomoses for typical hypoplastic left heart syndrome and similar complex cardiovascular malformations.

OBJECTIVEnFrom October 1989 to June 1998, 60 patients have undergone the Norwood procedure (stage I) at our institution. The results of the staged surgical reconstruction and risk factors were analysed. Typical hypoplastic left heart syndrome (HLHS) and complex lesions with aortic hypoplasia were compared with each other.nnnPATIENTSnTypical HLHS: N = 48, median age 15 days (5-190 days), median weight 3.6 kg (2.6-5.3 kg). Complex lesions (dominant left ventricle): N = 12, median age 59 days (10-884 days), median weight 3.4 kg (2.4-12 kg).nnnRESULTSnTypical HLHS: The stage-I hospital survival was 73% (35/48). It improved from 60% (95% confidence interval: 49-71%) during 1989-1994 to 91% (95% CI: 81-100%) during 1997-1998. Seven patients were lost late. The right ventricular end diastolic diameter (P = 0.015), shortening fraction (P = 0.027), and the presence of an obstructed pulmonary venous return (P = 0.0032) were significant risk factors. 23 children underwent stage-II operation with four (17%) deaths. All survivors experienced an improvement of their statomotoric development. Stage-III operation was performed in 13 patients with no hospital death. Follow up after stage-III procedure was 7 months to 7 years. 4 year actuarial survival, including hospital mortality and deaths at subsequent stages, improved from 28% (95% CI: 18-38%) during 1989-1994 to 58% (95% CI: 48-68%) during 1994-1997. No patient had signs of myocardial insufficiency. Complex lesions: Stage-I hospital survival was 83% (10/12) with no late death. Stage-II was performed in 8 and stage-III in 6 patients with no death respectively.nnnCONCLUSIONnIn typical HLHS the results have improved over time. Both size and function of the right ventricle determined significantly stage-I survival. An early operation prevents the natural progression of pulmonary blood flow and may weaken all three risk factors. Patients with complex lesions seemed to have better chances of surviving the early postoperative period. The multistage reconstructions have become a realistic option for patients with HLHS and similar lesions, regardless of the morphologic subtype or diminutiveness of the aorta, and lead to an acceptable quality of life.

Does the noise of mechanical heart valve prostheses affect quality of life as measured by the SF-36® questionnaire?

OBJECTIVEnThe closure clicks of mechanical heart valve prostheses leaflets are quite often clearly audible. The study describes the effects of subjective valve sound perception on the patients quality of life and analyses factors that might contribute to valve noise-related discomfort.nnnMETHODSnWe included 556 patients who received a mechanical valve prosthesis and participated in the study in our institution from 1994 to 1998. All compiled the standardised questionnaire Short-Form-36 Health Survey (SF-36) and indicated their subjective disturbance grade pre- and postoperatively, then every 6 months up to 2 years. A series of factors was scanned for correlation with unpleasant noise perception.nnnRESULTSnTwo years after the operation, only 5.8% classified their valve sounds as quite or very much disturbing. Age <60 years and being female were statistically significant factors for persisting unease caused by valve sounds. Without one of these factors, severe disturbance chance was 1.5%. As expected, quality of life improved after surgery. Patients disturbed seriously by valve noise showed significantly lower mean life quality values on each SF-36 scale.nnnCONCLUSIONnPatients (94.2%) with mechanical heart valve replacement have no persistent complaints about the valve noise. The grade of annoyance by valve noise is paralleled by lower average quality of life. Age under 60 years or being female increases the probability of severe disturbance due to mechanical valve sounds. It remains unclear whether the disturbing noise is reason or consequence of lower quality of life.

Primary repair of complete atrioventricular septal defect in infancy

Forty infants with complete atrioventricular septal defect have undergone primary repair within their 1st year of life. The mean age at time of surgery was 4 months (range 1-12 months) and the mean weight 4.2 kg (range 2.9-7.0 kg). Either the one- or the two-patch method was used. Four patients died (10%). There were no late deaths. Three patients needed reoperation due to mitral valve insufficiency. Postoperative complications were: 1 total atrioventricular block in an infant with an absent ventricular septum 3 weeks after surgery, 9 complete right bundle branch blocks, 3 small residual ventricular septal defects. Mean follow-up of the 36 survivors is 22 months (3-46 months). Thirty (83%) are in NYHA functional class I, 4 (11%) in NYHA class II and 2 (6%) in NYHA class III. No atrioventricular valve regurgitation is detectable by the color Doppler technique in 19 (53%) patients. Mitral incompetence is mild in 13 cases (36%) and moderate in 4 (11%). In ten recatheterized patients the average systolic pulmonary to systemic artery pressure ratio dropped from 1.0 to 0.42 and the average pulmonary arteriolar resistance was reduced from 5.5 to 3.9 U/m2. All but one patient gained weight and underwent adequate statomotoric development. Primary repair should be performed at the age of 5-6 months or even earlier, if pulmonary arteriolar resistance exceeds 5 U/m2.

INR-Selbstmanagement nach mechanischem Herzklappenersatz: ESCAT (Early Self-Controlled Anticoagulation Trial)

Severe thromboembolic and hemorrhagic complications following mechanical heart valve replacement essentially occur due to intense oral anticoagulation and fluctuating individual INR values around the target range. INR self-management can help to minimize these fluctuations. Beginning this therapeutic control immediately after mechanical heart valve replacement further reduces anticoagulant-induced complications. Included in the study were 1200 patients. The quality of oral anticoagulation also improved through INR self-management. Over an observation period of two years, nearly 80 % of INR values recorded by the patients themselves were within the target therapeutic range of 2.5–4.5. This corresponds to a high significance of p < = 0.001 in favor of INR self-management. Only 64.9 % of INR values monitored by family practitioners were within the desired range. The results differed slightly in quality between patient groups with different levels of training (comprehensive, secondary modern, grammar with or without university). Of patients trained in INR self-management following mechanical heart valve replacement, 91.7 % maintained their competence in this technique throughout the entire follow-up period. Only 8.3 % of those trained immediately after surgery were unable to continue with INR self-management. Grundproblematik und Methodik Das Auftreten von schwerwiegenden, thrombembolischen und hämorrhagischen Komplikationen nach mechanischem Herzklappenersatz ist im Wesentlichen abhängig von der Intensität der oralen Antikoagulation und der Schwankung der einzelnen INR-Messwerte um den Zielbereich. Das INR-Selbstmanagement ist in der Lage, diese Schwankungen zu minimieren. Insbesondere durch den frühen postoperativen Beginn dieser Therapiekontrolle wird eine weitere Reduktion von antikoagulanzieninduzierten Komplikationen bewirkt. Mit dieser Arbeit soll geklärt werden, inwieweit ein unmittelbar postoperativ eingeführtes INR-Selbstmanagement nach mechanischem Herzklappenersatz zu einer verbesserten Therapiecompliance und hieraus resultierend zu einer Reduktion der thrombembolischen Komplikationsrate führt. Patienten und Methodik Insgesamt wurden 1200 Patienten in die ESCAT-Studie eingeschlossen, hiervon konnten 45 Patienten bei der Auswertung nicht berücksichtigt werden, da in 29 Fällen biologische Herzklappen implantiert wurden und 16 Patienten (1,3 %) nicht in der Lage waren, das Studienprotokoll zu erfüllen, somit ergab sich eine Grundpopulation von 1155 Patienten. Entsprechend der Randomisierung entfielen 576 Patienten (49,9 %) in die konventionelle Gruppe, in welcher die Antikoagulationstherapie vom Hausarzt durchgeführt wurde. Auf die Gruppe der Patienten, welche das INR-Selbstmanagement durchführten, entfielen 579 Patienten (50,1 %). Die INR-Werte und Komplikationsereignisse wurden in monatlichen Intervallen mittels Patientenprotokollbogen an das Studienzentrum geschickt. Ergebnisse Die INR-Selbstmanagementgruppe hatte signifikant weniger schwerwiegende Thrombembolien (p = 0,026). Das INR-Selbstmanagement bewirkt eine hohe Qualitatsverbesserung der laufenden oralen Antikoagulation. Annahernd 80 % der von den Patienten ermittelten INR-Werte lagen im vorgegebenen Therapiekorridor von INR 2,5–4,5. Hieraus resultiert eine hochst signifikante Differenz mit p ≤ 0,001 zugunsten des INR-Selbstmanagements. Nur 64,9 % der INR-Werte der konventionell kontrollierten Patienten lagen im gewunschen Therapiebereich. Die thrombembolische Komplikationsrate konnte von 2,8 % pro Patientenjahr auf 1,5 % pro Patientenjahr reduziert werden, unabhangig von der gewahlten Klappenposition, allein durch einen fruhen Beginn des INR-Selbstmanagements unmittelbar nach einem mechanischem Herzklappenersatz. Folgerung 91,7% der Patienten mit Einfuhrung ins INR-Selbstmanagement nach mechanischem Herzklappenersatz zeigten uber die gesamte Follow-up-Zeit ihre Kompetenz hinsichtlich des INR-Selbstmanagements. Nur 8,3 % der Patienten gaben ihren INR-Gerinnungsmonitor zuruck. Sie fuhlten sich nicht in der Lage, das INR-Selbstmanagement durchzufuhren. Insgesamt konnte eine signifikante thrombembolische Komplikationsreduktion nachgewiesen werden.

Das anatomische und funktionelle hypoplastische Linksherz-Syndrom und seine chirurgische Behandlung nach Norwood und Fontan

Die chirurgische Versorgung von Neugeborenen mit hypoplastischem Linksherz-Syndrom (HLHS) wird immer noch zurückhaltend betrachtet. Die komplette herzerhaltende Palliation beinhaltet neben der Norwood-Operation im Neugeborenenalter auch die spätere Kreislauftrennung nach Fontan. Unsere Erfahrungen mit den einzelnen operativen Teilschritten werden vorgestellt. 43 Säuglinge mit anatomischem (n = 33) oder funktionellem (n = 10) HLHS erhielten von 1989 bis 1996 eine Norwood-Operation. Funktionelle HLHS waren: Mitralatresie mit doppeltem Ausgang aus der rechten Kammer und subaortaler Stenose (n = 2), atrioventrikulärer Septumdefekt mit hypoplastischer linker Kammer, Subaortenstenose und Aortenkoarktation (n = 1), hypoplastischer, subaortaler rechter Ventrikel mit restriktivem Ventrikelseptumdefekt und Aortenhypoplasie (n = 7). Das mediane Operationsalter betrug 15 Tage (5 bis 182 Tage), das mittlere Gewicht war 3,3 kg (3,0 bis 4,9 kg). Die operative Sterblichkeit lag bei 32% (n = 14), wobei sie seit 1994 auf 16% (3 von 19 Patienten) gesenkt werden konnte. 5 Patienten (12%) verstarben 2 Wochen bis 6 Monate später, 2 Kinder wurden herztransplantiert. Von den 22 lang Überlebenden erhielten bisher 19 Patienten im medianen Alter von 7 Monaten (2 bis 14 Monate) die obere, bidirektionale kavopulmonale Anastomose als Hemi-Fontan. 2 Kinder verstarben (10%).Von den 17 Überlebenden erhielten bisher 12 nach einem mittleren Intervall von 12 Monaten die ergänzende kavopulmonale Anastomose. Alle Kinder überlebten den Eingriff und sind damit fertig palliiert. Die längste Nachbeobachtung nach kompletter Fontan-Operation liegt bisher bei 6 Jahren. Zusammenfassung: Die Ergebnisse der Norwood-Operation werden mit wachsender Erfahrung günstiger. Die nachfolgende zweischrittige Fontan-Operation hat dann nur noch ein relativ geringes Risiko und führt zu einer sehr guten Lebensqualität. The surgical therapy of newborns with hypoplastic left heart syndrome (HLHS) is still regarded with some distrust. The complete heart conserving palliation includes not only the Norwood operation during the newborn period but also the complete separation of both circuits by the Fontan operation some time later. Our experiences with each surgical step are presented. From 1989 to 1996 43 infants with anatomical (n = 33) or functional (n = 10) HLHS underwent the Norwood operation. Functional HLHS were: Mitralatresia with double outlet right ventricle and subaortic stenosis (n = 2), atrioventricular septal defect with hypoplastic left ventricle, subaortic stenosis, and aortic coarctation (n = 1), hypoplastic, subaortic right ventricle with restrictive ventricular septal defect and aortic hypoplasia (n = 7). The median age at operation was 15 days ( 5 to 182 days), mean weight was 3.3 kg (3.0 to 4.9 kg). Total operative mortality was 32% (n = 14) with 16% since 1994 (3/19 patients). Five infants (12%) died 2 weeks to 6 months later, and 2 patients underwent cardiac transplantation. Up to now, 10 out of the 22 long term survivors underwent the bidirectional cavopulmonary anastomosis (Hemi-Fontan) at a median age of 7 months (2 to 14 months). Two infants died (10%). Up to now, 12 out of the remaining 17 survivors received the total cavopulmonary anastomosis after a mean period of 12 months. All children survived, and they are now completely palliated. The longest follow up after the complete Fontan operation is 6 years. Conclusion: With increasing experience the results of the Norwood operation improved. The following two-stage Fontan procedure bears only low risk and leads to good life quality.

Stentless xenograft valve in a truncus arteriosus communis.

We report the use of a recently developed stentless porcine valve in a 2-year-old child with truncus arteriosus communis (type I). The child had received no previous surgical palliation. Despite a markedly increased pulmonary arteriolar resistance the right ventricle was connected to the pulmonary artery with a homograft. The postoperative course was complicated at first by right ventricular failure due to pulmonary hypertension and secondarily by left ventricular failure caused by rapidly increasing truncal valve incompetence. Because we did not have a suitable homograft at hand we replaced the truncal valve with a stentless porcine xenograft valve.