Bärbel Klein

There are two sides to everything: two case reports on sequelae of rescue interventions to treat complications of transcatheter aortic valve implantation of the Medtronic CoreValve™ prosthesis

Percutaneous transcatheter aortic valve implantation (TAVI) is becoming an increasingly preferred option for the treatment of severe symptomatic aortic stenosis in patients not suitable or at high risk for surgical valve replacement. Currently, the retrograde approach over the femoral artery and retrograde passage of the aortic valve is preferred [6, 7, 21]. Either the balloon-expandable SapienEdwards prosthesis (Edwards Lifesciences, Irvine, CA, USA) or the selfexpanding Medtronic CoreValve Revalving system (Medtronic CoreValve, Irvine, CA, USA) can be used. Alternatively to the trans-femoral approach a minimal-invasive trans-apical approach [16, 18, 19] or a trans-subclavian/trans-axillary approach [1, 3] can be used. Data from a European TAVI registry showed promising acute and mid-term results for this new option in high surgical risk patients [12]. Although less invasive than surgical therapy, some serious complications, such as cerebral embolism, pericardial tamponade, severe aortic insufficiencies, aortic dissections or aortic or cardiac ruptures as well as access complications can occur during TAVI [5–7, 10, 21]. Some of these complications can be treated with catheter-based techniques: Severe aortic insufficiency due to too deep implantation of the Medtronic CoreValve may be treated with either implantation of a second valve (‘‘Russian doll’’concept) [5, 13] or by catheter-based repositioning of the valve [5, 7, 17, 23]; para-valvular leakage can be treated by implantation of a plug device [8, 15] and misplacement of the valve can be treated by retracting the device if it is only partially released followed by a re-implantation [17]. However, such rescue interventions are challenging procedures which are time-consuming and may themselves cause complications. We report on two patients who, after being initially treated with catheter-based techniques to cope with complications of TAVI, developed complications due to these rescue interventions.

Trends im Einsatz von Drug-eluting Stents im klinischen Alltag in Deutschland

BACKGROUND AND PURPOSE : Drug-eluting stents (DES) have been shown to reduce the risk of in-stent stenosis, one of the major problems of percutaneous coronary intervention (PCI) with implantation of baremetal stents. DES are approved in Germany since 2002. The following study is based on data of the ALKK PCI registry and assesses the use of DES depending on patient characteristics, indication and coronary status comparing the treatment years 2003 and 2005. METHODS : The ALKK (Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte) PCI registry is focused on quality management based on guidelines in coronary interventions. Data were obtained by standardized questionnaires and analyzed centrally at the KL-Neuhaus Datenzentrum, Ludwigshafen, Germany. For this study, data of 40,434 PCI procedures of 32 hospitals were obtained. RESULTS : In 2003, a total of 18,564 PCIs, and in 2005, a total of 21,870 PCIs were registered. Figure 1 shows the rate of DES in PCI in the hospitals participating in the registry in both years, 2003 and 2005. The use of DES was low with 4.3% in 2003 and increased to 19.1% in 2005. DES were mostly used in patients with stable angina (2003: 68.4%, 2005: 55.3%), in patients with former PCI (2003: 42.5%, 2005: 48.1%) and a positive stress test (DES 2003: 58.4%, 2005: 32.0%; Table 1). The rate of DES was high in unprotected left main procedures (DES 2003: 15.6%, 2005: 35.9%), PCI of ostial lesions (DES 2003: 6.4%, 2005: 32.7%), in in-stent stenosis (DES 2003: 9.5%, 2005: 40.6%), and in multivessel PCI (DES 2003: 7.6%, 2005: 29.3%; Figure 3). CONCLUSION : DES were mainly applied in a stable situation (Figure 2), but were also increasingly used for complex coronary interventions in off-label indications.ZusammenfassungHintergrund und Ziel:Medikamente freisetzende Stents („drug-eluting stents“ [DES]) zeichnen sich im Vergleich zu unbeschichteten Metallstents durch eine niedrigere Restenoserate aus. Seit 2002 sind sie in Deutschland zugelassen. Die folgende Analyse zeigt die Verwendung von DES im klinischen Alltag sowie Determinanten des Einsatzes in den Jahren 2003 und 2005 in Deutschland.Methodik:Das ALKK-Register (Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte) erfasst konsekutiv klinische und prozedurale Parameter interventionell behandelter Patienten mittels standardisierter Fragebögen, welche zur Datenzentrale des KL-Neuhaus Datenzentrums (Ludwigshafen) weitergeleitet werden. Die folgende Analyse umfasst die Daten von 40 434 Koronarinterventionen (PCIs), welche in den Jahren 2003 und 2005 an 32 Kliniken durchgeführt wurden.Ergebnisse:Insgesamt wurden 2003 18 564 PCIs und 2005 21 870 PCIs erfasst. Der Anteil von DES lag 2003 bei 4,3% und stieg bis 2005 auf 19,1% an. Die Hauptindikation für die Implantation eines DES war die stabile Angina pectoris (2003: 68,4%, 2005: 55,3%); DES wurden vor allem bei Patienten mit bekannter PCI eingesetzt (2003: 42,5%, 2005: 48,1%) . Der Anteil von DES bei komplexen Prozeduren war besonders hoch bei Interventionen am ungeschützten Hauptstamm (DES 2003: 15,6%, 2005: 35,9%), einer Ostiumstenose (DES 2003: 6,4%, 2005: 32,7%), bei In-Stent-Stenose (DES 2003: 9,5%, 2005: 40,6%) und Interventionen an mehr als einem Versorgungsgebiet (DES 2003: 7,6%, 2005: 29,3%).Schlussfolgerung:DES wurden vorwiegend bei stabiler Angina pectoris eingesetzt, allerdings mit zunehmendem Anteil auch bei komplexen Koronarläsionen im Off-Label-Bereich.AbstractBackground and Purpose:Drug-eluting stents (DES) have been shown to reduce the risk of in-stent stenosis, one of the major problems of percutaneous coronary intervention (PCI) with implantation of baremetal stents. DES are approved in Germany since 2002. The following study is based on data of the ALKK PCI registry and assesses the use of DES depending on patient characteristics, indication and coronary status comparing the treatment years 2003 and 2005.Methods:The ALKK (Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte) PCI registry is focused on quality management based on guidelines in coronary interventions. Data were obtained by standardized questionnaires and analyzed centrally at the KL-Neuhaus Datenzentrum, Ludwigshafen, Germany. For this study, data of 40,434 PCI procedures of 32 hospitals were obtained.Results:In 2003, a total of 18,564 PCIs, and in 2005, a total of 21,870 PCIs were registered. Figure 1 shows the rate of DES in PCI in the hospitals participating in the registry in both years, 2003 and 2005. The use of DES was low with 4.3% in 2003 and increased to 19.1% in 2005. DES were mostly used in patients with stable angina (2003: 68.4%, 2005: 55.3%), in patients with former PCI (2003: 42.5%, 2005: 48.1%) and a positive stress test (DES 2003: 58.4%, 2005: 32.0%; Table 1). The rate of DES was high in unprotected left main procedures (DES 2003: 15.6%, 2005: 35.9%), PCI of ostial lesions (DES 2003: 6.4%, 2005: 32.7%), in in-stent stenosis (DES 2003: 9.5%, 2005: 40.6%), and in multivessel PCI (DES 2003: 7.6%, 2005: 29.3%; Figure 3).Conclusion:DES were mainly applied in a stable situation (Figure 2), but were also increasingly used for complex coronary interventions in off-label indications.

[Temporal trends in the use of drug-eluting stents in German clinical practice].

BACKGROUND AND PURPOSE : Drug-eluting stents (DES) have been shown to reduce the risk of in-stent stenosis, one of the major problems of percutaneous coronary intervention (PCI) with implantation of baremetal stents. DES are approved in Germany since 2002. The following study is based on data of the ALKK PCI registry and assesses the use of DES depending on patient characteristics, indication and coronary status comparing the treatment years 2003 and 2005. METHODS : The ALKK (Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte) PCI registry is focused on quality management based on guidelines in coronary interventions. Data were obtained by standardized questionnaires and analyzed centrally at the KL-Neuhaus Datenzentrum, Ludwigshafen, Germany. For this study, data of 40,434 PCI procedures of 32 hospitals were obtained. RESULTS : In 2003, a total of 18,564 PCIs, and in 2005, a total of 21,870 PCIs were registered. Figure 1 shows the rate of DES in PCI in the hospitals participating in the registry in both years, 2003 and 2005. The use of DES was low with 4.3% in 2003 and increased to 19.1% in 2005. DES were mostly used in patients with stable angina (2003: 68.4%, 2005: 55.3%), in patients with former PCI (2003: 42.5%, 2005: 48.1%) and a positive stress test (DES 2003: 58.4%, 2005: 32.0%; Table 1). The rate of DES was high in unprotected left main procedures (DES 2003: 15.6%, 2005: 35.9%), PCI of ostial lesions (DES 2003: 6.4%, 2005: 32.7%), in in-stent stenosis (DES 2003: 9.5%, 2005: 40.6%), and in multivessel PCI (DES 2003: 7.6%, 2005: 29.3%; Figure 3). CONCLUSION : DES were mainly applied in a stable situation (Figure 2), but were also increasingly used for complex coronary interventions in off-label indications.ZusammenfassungHintergrund und Ziel:Medikamente freisetzende Stents („drug-eluting stents“ [DES]) zeichnen sich im Vergleich zu unbeschichteten Metallstents durch eine niedrigere Restenoserate aus. Seit 2002 sind sie in Deutschland zugelassen. Die folgende Analyse zeigt die Verwendung von DES im klinischen Alltag sowie Determinanten des Einsatzes in den Jahren 2003 und 2005 in Deutschland.Methodik:Das ALKK-Register (Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte) erfasst konsekutiv klinische und prozedurale Parameter interventionell behandelter Patienten mittels standardisierter Fragebögen, welche zur Datenzentrale des KL-Neuhaus Datenzentrums (Ludwigshafen) weitergeleitet werden. Die folgende Analyse umfasst die Daten von 40 434 Koronarinterventionen (PCIs), welche in den Jahren 2003 und 2005 an 32 Kliniken durchgeführt wurden.Ergebnisse:Insgesamt wurden 2003 18 564 PCIs und 2005 21 870 PCIs erfasst. Der Anteil von DES lag 2003 bei 4,3% und stieg bis 2005 auf 19,1% an. Die Hauptindikation für die Implantation eines DES war die stabile Angina pectoris (2003: 68,4%, 2005: 55,3%); DES wurden vor allem bei Patienten mit bekannter PCI eingesetzt (2003: 42,5%, 2005: 48,1%) . Der Anteil von DES bei komplexen Prozeduren war besonders hoch bei Interventionen am ungeschützten Hauptstamm (DES 2003: 15,6%, 2005: 35,9%), einer Ostiumstenose (DES 2003: 6,4%, 2005: 32,7%), bei In-Stent-Stenose (DES 2003: 9,5%, 2005: 40,6%) und Interventionen an mehr als einem Versorgungsgebiet (DES 2003: 7,6%, 2005: 29,3%).Schlussfolgerung:DES wurden vorwiegend bei stabiler Angina pectoris eingesetzt, allerdings mit zunehmendem Anteil auch bei komplexen Koronarläsionen im Off-Label-Bereich.AbstractBackground and Purpose:Drug-eluting stents (DES) have been shown to reduce the risk of in-stent stenosis, one of the major problems of percutaneous coronary intervention (PCI) with implantation of baremetal stents. DES are approved in Germany since 2002. The following study is based on data of the ALKK PCI registry and assesses the use of DES depending on patient characteristics, indication and coronary status comparing the treatment years 2003 and 2005.Methods:The ALKK (Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte) PCI registry is focused on quality management based on guidelines in coronary interventions. Data were obtained by standardized questionnaires and analyzed centrally at the KL-Neuhaus Datenzentrum, Ludwigshafen, Germany. For this study, data of 40,434 PCI procedures of 32 hospitals were obtained.Results:In 2003, a total of 18,564 PCIs, and in 2005, a total of 21,870 PCIs were registered. Figure 1 shows the rate of DES in PCI in the hospitals participating in the registry in both years, 2003 and 2005. The use of DES was low with 4.3% in 2003 and increased to 19.1% in 2005. DES were mostly used in patients with stable angina (2003: 68.4%, 2005: 55.3%), in patients with former PCI (2003: 42.5%, 2005: 48.1%) and a positive stress test (DES 2003: 58.4%, 2005: 32.0%; Table 1). The rate of DES was high in unprotected left main procedures (DES 2003: 15.6%, 2005: 35.9%), PCI of ostial lesions (DES 2003: 6.4%, 2005: 32.7%), in in-stent stenosis (DES 2003: 9.5%, 2005: 40.6%), and in multivessel PCI (DES 2003: 7.6%, 2005: 29.3%; Figure 3).Conclusion:DES were mainly applied in a stable situation (Figure 2), but were also increasingly used for complex coronary interventions in off-label indications.

Trends im Einsatz von Drug-eluting Stents im klinischen Alltag in DeutschlandTemporal Trends in the Use of Drug-Eluting Stents in German Clinical Practice

BACKGROUND AND PURPOSE : Drug-eluting stents (DES) have been shown to reduce the risk of in-stent stenosis, one of the major problems of percutaneous coronary intervention (PCI) with implantation of baremetal stents. DES are approved in Germany since 2002. The following study is based on data of the ALKK PCI registry and assesses the use of DES depending on patient characteristics, indication and coronary status comparing the treatment years 2003 and 2005. METHODS : The ALKK (Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte) PCI registry is focused on quality management based on guidelines in coronary interventions. Data were obtained by standardized questionnaires and analyzed centrally at the KL-Neuhaus Datenzentrum, Ludwigshafen, Germany. For this study, data of 40,434 PCI procedures of 32 hospitals were obtained. RESULTS : In 2003, a total of 18,564 PCIs, and in 2005, a total of 21,870 PCIs were registered. Figure 1 shows the rate of DES in PCI in the hospitals participating in the registry in both years, 2003 and 2005. The use of DES was low with 4.3% in 2003 and increased to 19.1% in 2005. DES were mostly used in patients with stable angina (2003: 68.4%, 2005: 55.3%), in patients with former PCI (2003: 42.5%, 2005: 48.1%) and a positive stress test (DES 2003: 58.4%, 2005: 32.0%; Table 1). The rate of DES was high in unprotected left main procedures (DES 2003: 15.6%, 2005: 35.9%), PCI of ostial lesions (DES 2003: 6.4%, 2005: 32.7%), in in-stent stenosis (DES 2003: 9.5%, 2005: 40.6%), and in multivessel PCI (DES 2003: 7.6%, 2005: 29.3%; Figure 3). CONCLUSION : DES were mainly applied in a stable situation (Figure 2), but were also increasingly used for complex coronary interventions in off-label indications.ZusammenfassungHintergrund und Ziel:Medikamente freisetzende Stents („drug-eluting stents“ [DES]) zeichnen sich im Vergleich zu unbeschichteten Metallstents durch eine niedrigere Restenoserate aus. Seit 2002 sind sie in Deutschland zugelassen. Die folgende Analyse zeigt die Verwendung von DES im klinischen Alltag sowie Determinanten des Einsatzes in den Jahren 2003 und 2005 in Deutschland.Methodik:Das ALKK-Register (Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte) erfasst konsekutiv klinische und prozedurale Parameter interventionell behandelter Patienten mittels standardisierter Fragebögen, welche zur Datenzentrale des KL-Neuhaus Datenzentrums (Ludwigshafen) weitergeleitet werden. Die folgende Analyse umfasst die Daten von 40 434 Koronarinterventionen (PCIs), welche in den Jahren 2003 und 2005 an 32 Kliniken durchgeführt wurden.Ergebnisse:Insgesamt wurden 2003 18 564 PCIs und 2005 21 870 PCIs erfasst. Der Anteil von DES lag 2003 bei 4,3% und stieg bis 2005 auf 19,1% an. Die Hauptindikation für die Implantation eines DES war die stabile Angina pectoris (2003: 68,4%, 2005: 55,3%); DES wurden vor allem bei Patienten mit bekannter PCI eingesetzt (2003: 42,5%, 2005: 48,1%) . Der Anteil von DES bei komplexen Prozeduren war besonders hoch bei Interventionen am ungeschützten Hauptstamm (DES 2003: 15,6%, 2005: 35,9%), einer Ostiumstenose (DES 2003: 6,4%, 2005: 32,7%), bei In-Stent-Stenose (DES 2003: 9,5%, 2005: 40,6%) und Interventionen an mehr als einem Versorgungsgebiet (DES 2003: 7,6%, 2005: 29,3%).Schlussfolgerung:DES wurden vorwiegend bei stabiler Angina pectoris eingesetzt, allerdings mit zunehmendem Anteil auch bei komplexen Koronarläsionen im Off-Label-Bereich.AbstractBackground and Purpose:Drug-eluting stents (DES) have been shown to reduce the risk of in-stent stenosis, one of the major problems of percutaneous coronary intervention (PCI) with implantation of baremetal stents. DES are approved in Germany since 2002. The following study is based on data of the ALKK PCI registry and assesses the use of DES depending on patient characteristics, indication and coronary status comparing the treatment years 2003 and 2005.Methods:The ALKK (Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte) PCI registry is focused on quality management based on guidelines in coronary interventions. Data were obtained by standardized questionnaires and analyzed centrally at the KL-Neuhaus Datenzentrum, Ludwigshafen, Germany. For this study, data of 40,434 PCI procedures of 32 hospitals were obtained.Results:In 2003, a total of 18,564 PCIs, and in 2005, a total of 21,870 PCIs were registered. Figure 1 shows the rate of DES in PCI in the hospitals participating in the registry in both years, 2003 and 2005. The use of DES was low with 4.3% in 2003 and increased to 19.1% in 2005. DES were mostly used in patients with stable angina (2003: 68.4%, 2005: 55.3%), in patients with former PCI (2003: 42.5%, 2005: 48.1%) and a positive stress test (DES 2003: 58.4%, 2005: 32.0%; Table 1). The rate of DES was high in unprotected left main procedures (DES 2003: 15.6%, 2005: 35.9%), PCI of ostial lesions (DES 2003: 6.4%, 2005: 32.7%), in in-stent stenosis (DES 2003: 9.5%, 2005: 40.6%), and in multivessel PCI (DES 2003: 7.6%, 2005: 29.3%; Figure 3).Conclusion:DES were mainly applied in a stable situation (Figure 2), but were also increasingly used for complex coronary interventions in off-label indications.

Trends im Einsatz von Drug-eluting Stents im klinischen Alltag in Deutschland@@@Temporal Trends in the Use of Drug-Eluting Stents in German Clinical Practice: Daten des ALKK-Registers

BACKGROUND AND PURPOSE : Drug-eluting stents (DES) have been shown to reduce the risk of in-stent stenosis, one of the major problems of percutaneous coronary intervention (PCI) with implantation of baremetal stents. DES are approved in Germany since 2002. The following study is based on data of the ALKK PCI registry and assesses the use of DES depending on patient characteristics, indication and coronary status comparing the treatment years 2003 and 2005. METHODS : The ALKK (Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte) PCI registry is focused on quality management based on guidelines in coronary interventions. Data were obtained by standardized questionnaires and analyzed centrally at the KL-Neuhaus Datenzentrum, Ludwigshafen, Germany. For this study, data of 40,434 PCI procedures of 32 hospitals were obtained. RESULTS : In 2003, a total of 18,564 PCIs, and in 2005, a total of 21,870 PCIs were registered. Figure 1 shows the rate of DES in PCI in the hospitals participating in the registry in both years, 2003 and 2005. The use of DES was low with 4.3% in 2003 and increased to 19.1% in 2005. DES were mostly used in patients with stable angina (2003: 68.4%, 2005: 55.3%), in patients with former PCI (2003: 42.5%, 2005: 48.1%) and a positive stress test (DES 2003: 58.4%, 2005: 32.0%; Table 1). The rate of DES was high in unprotected left main procedures (DES 2003: 15.6%, 2005: 35.9%), PCI of ostial lesions (DES 2003: 6.4%, 2005: 32.7%), in in-stent stenosis (DES 2003: 9.5%, 2005: 40.6%), and in multivessel PCI (DES 2003: 7.6%, 2005: 29.3%; Figure 3). CONCLUSION : DES were mainly applied in a stable situation (Figure 2), but were also increasingly used for complex coronary interventions in off-label indications.ZusammenfassungHintergrund und Ziel:Medikamente freisetzende Stents („drug-eluting stents“ [DES]) zeichnen sich im Vergleich zu unbeschichteten Metallstents durch eine niedrigere Restenoserate aus. Seit 2002 sind sie in Deutschland zugelassen. Die folgende Analyse zeigt die Verwendung von DES im klinischen Alltag sowie Determinanten des Einsatzes in den Jahren 2003 und 2005 in Deutschland.Methodik:Das ALKK-Register (Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte) erfasst konsekutiv klinische und prozedurale Parameter interventionell behandelter Patienten mittels standardisierter Fragebögen, welche zur Datenzentrale des KL-Neuhaus Datenzentrums (Ludwigshafen) weitergeleitet werden. Die folgende Analyse umfasst die Daten von 40 434 Koronarinterventionen (PCIs), welche in den Jahren 2003 und 2005 an 32 Kliniken durchgeführt wurden.Ergebnisse:Insgesamt wurden 2003 18 564 PCIs und 2005 21 870 PCIs erfasst. Der Anteil von DES lag 2003 bei 4,3% und stieg bis 2005 auf 19,1% an. Die Hauptindikation für die Implantation eines DES war die stabile Angina pectoris (2003: 68,4%, 2005: 55,3%); DES wurden vor allem bei Patienten mit bekannter PCI eingesetzt (2003: 42,5%, 2005: 48,1%) . Der Anteil von DES bei komplexen Prozeduren war besonders hoch bei Interventionen am ungeschützten Hauptstamm (DES 2003: 15,6%, 2005: 35,9%), einer Ostiumstenose (DES 2003: 6,4%, 2005: 32,7%), bei In-Stent-Stenose (DES 2003: 9,5%, 2005: 40,6%) und Interventionen an mehr als einem Versorgungsgebiet (DES 2003: 7,6%, 2005: 29,3%).Schlussfolgerung:DES wurden vorwiegend bei stabiler Angina pectoris eingesetzt, allerdings mit zunehmendem Anteil auch bei komplexen Koronarläsionen im Off-Label-Bereich.AbstractBackground and Purpose:Drug-eluting stents (DES) have been shown to reduce the risk of in-stent stenosis, one of the major problems of percutaneous coronary intervention (PCI) with implantation of baremetal stents. DES are approved in Germany since 2002. The following study is based on data of the ALKK PCI registry and assesses the use of DES depending on patient characteristics, indication and coronary status comparing the treatment years 2003 and 2005.Methods:The ALKK (Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte) PCI registry is focused on quality management based on guidelines in coronary interventions. Data were obtained by standardized questionnaires and analyzed centrally at the KL-Neuhaus Datenzentrum, Ludwigshafen, Germany. For this study, data of 40,434 PCI procedures of 32 hospitals were obtained.Results:In 2003, a total of 18,564 PCIs, and in 2005, a total of 21,870 PCIs were registered. Figure 1 shows the rate of DES in PCI in the hospitals participating in the registry in both years, 2003 and 2005. The use of DES was low with 4.3% in 2003 and increased to 19.1% in 2005. DES were mostly used in patients with stable angina (2003: 68.4%, 2005: 55.3%), in patients with former PCI (2003: 42.5%, 2005: 48.1%) and a positive stress test (DES 2003: 58.4%, 2005: 32.0%; Table 1). The rate of DES was high in unprotected left main procedures (DES 2003: 15.6%, 2005: 35.9%), PCI of ostial lesions (DES 2003: 6.4%, 2005: 32.7%), in in-stent stenosis (DES 2003: 9.5%, 2005: 40.6%), and in multivessel PCI (DES 2003: 7.6%, 2005: 29.3%; Figure 3).Conclusion:DES were mainly applied in a stable situation (Figure 2), but were also increasingly used for complex coronary interventions in off-label indications.